i

Food Code

2022 Recommendations of the

United States Public Health Service

Food and Drug Administration

The Food Code is a model for safeguarding public health and ensuring food is unadulterated 

and honestly presented when offered to the consumer. It represents FDA's best advice for a 

uniform system of provisions that address the safety and protection of food offered at retail 

and in food service. 

This model is offered for adoption by local, state, and federal governmental jurisdictions for 

administration by the various departments, agencies, bureaus, divisions, and other units 

within each jurisdiction that have been delegated compliance responsibilities for food 

service, retail food stores, or food vending operations. Alternatives that offer an equivalent 

level of public health protection to ensure that food at retail and foodservice is safe are 

recognized in this model.

January 18, 2023 Version
ii

Previous Editions of Codes

Recommended by The

United States Public Health Service

for 

Regulating Operations Providing Food Directly to the Consumer

1934 - Restaurant Sanitation Regulations,

Proposed by the U.S. Public Health Service in cooperation with the Conference of State and 

Territorial Health Officers and the National Restaurant Code Authority

1935 - An Ordinance Regulating Food and Drink Establishments

(Recommended by U.S. Public Health Service), December 1935, Mimeographed

1938 - Ordinance and Code Regulating Eating and Drinking Establishments, Recommended

by the U.S. Public Health Service, March 1938, Mimeographed

1940 - Ordinance and Code Regulating Eating and Drinking Establishments, Recommended

by the U.S. Public Health Service, June 1940, Mimeographed

1943 - Ordinance and Code Regulating Eating and Drinking Establishments, Recommended

by the United States Public Health Service, 1943, FSA, Public Health Bulletin No. 280

(Republished in 1955, DHEW, PHS Publication No. 37)

1957 - The Vending of Foods and Beverages - A Sanitation Ordinance and Code, 1957

Recommendations of the Public Health Service, DHEW, PHS Publication No. 546

1962 - Food Service Sanitation Manual Including A Model Food Service Sanitation Ordinance

and Code, 1962 Recommendations of the Public Health Service, DHEW, PHS

Publication No. 934

1965 - The Vending of Food and Beverages - A Sanitation Ordinance and Code, 1965

Recommendations of the Public Health Service, DHEW, PHS Publication No. 546

1976 - Food Service Sanitation Manual Including A Model Food Service Sanitation Ordinance,

1976 Recommendations of the Food and Drug Administration, DHEW/PHS/FDA, DHEW

Publication No. (FDA) 78-2091

1978 - The Vending of Food and Beverages Including A Model Sanitation Ordinance, 1978

Recommendations of the Food and Drug Administration, DHEW/PHS/FDA, DHEW

Publication No. (FDA) 78-2091

1982 - Retail Food Store Sanitation Code, 1982 Recommendations of the Association of Food

and Drug Officials and U.S. Department of Health and Human Services, Public Health

Service, Food and Drug Administration, AFDO/HHS Publication

1993 - Food Code, 1993 Recommendations of the United States Public Health Service, Food and 

Drug Administration, National Technical Information Service Publication PB94-113941

1995 - Food Code, 1995 Recommendations of the United States Public Health Service, Food and 
iii

Drug Administration, National Technical Information Service Publication PB95-265492

1997 - Food Code, 1997 Recommendations of the United States Public Health Service, 

Food and Drug Administration, National Technical Information Service Publication 

PB97-133656 

1999 - Food Code, 1999 Recommendations of the United States Public Health Service, 

Food and Drug Administration, National Technical Information Service Publication 

PB99-115925

2001 - Food Code, 2001Recommendations of the United States Public Health Service, 

Food and Drug Administration, National Technical Information Service Publication 

PB2002-100819

2003 - Supplement to the 2001 Food Code, National Technical Information Service 

Publication PB2003-106843

2005 - Food Code, 2005 Recommendations of the United States Public Health Service, 

Food and Drug Administration, National Technical Information Service Publication 

PB2005-102200

2007 - Supplement to the 2005 Food Code, National Technical Information Service 

Publication PB2007-112622 

2009 - Food Code, 2009 Recommendations of the United States Public Health Service, 

Food and Drug Administration, National Technical Information Service Publication 

PB2009-112613

2011 - Supplement to the 2009 Food Code, National Technical Information Service 

Publication PB2011-114303 

2013 - Food Code, 2013 Recommendations of the United States Public Health Service, 

Food and Drug Administration, National Technical Information Service Publication 

PB2013-110462

2015 - Supplement to the 2013 Food Code, National Technical Information Service 

Publication PB2015-104921 

2017 - Food Code, 2017 Recommendations of the United States Public Health Service, 

Food and Drug Administration, HHS Program Support Center, Publication number 

IFS17

2019 - Supplement to the 2017 Food Code, This document is available via the internet in 

PDF at the following link: www.fda.gov/foodcode
FDA Food Code 2022 Preface

Preface - i 

Preface

1. Foodborne Illness Estimates, Risk Factors, and Interventions

Foodborne illness in the United States is a major cause of personal distress, 

preventable illness and death, and avoidable economic burden. Scallan et al. (2011a,b) 

estimated that foodborne diseases cause approximately 48 million illnesses, 128,000 

hospitalizations, and 3,000 deaths in the United States each year. The occurrence of 

approximately 1,000 reported disease outbreaks (local, regional, and national) each 

year highlights the challenges of preventing these infections.

Most foodborne illnesses occur in persons who are not part of recognized outbreaks. 

For many victims, foodborne illness results only in discomfort or lost time from the job. 

For some, especially preschool age children, older adults in health care facilities, and 

those with impaired immune systems, foodborne illness is more serious and may be life 

threatening.

The annual cost of foodborne illness in terms of pain and suffering, reduced 

productivity, and medical costs are estimated to be $10 - $83 billion. As stated by 

Meade et. al., the nature of food and foodborne illness has changed dramatically in the 

United States over the last century. While technological advances such as 

pasteurization and proper canning have all but eliminated some disease, new causes of 

foodborne illness have been identified. Surveillance of foodborne illness is complicated 

by several factors. The first is underreporting. Although foodborne illnesses can be 

severe or even fatal, milder cases are often not detected through routine surveillance. 

Second, many pathogens transmitted through food are also spread through water or 

from person to person, thus obscuring the role of foodborne transmission. Finally, 

pathogens or agents that have not yet been identified and thus cannot be diagnosed 

cause some proportion of foodborne illness. 

Epidemiological outbreak data repeatedly identify five major risk factors related to 

employee behaviors and preparation practices in retail and food service establishments 

as contributing to foodborne illness: 

• Improper holding temperatures,

• Inadequate cooking, such as undercooking raw shell eggs,

• Contaminated equipment,

• Food from unsafe sources, and

• Poor personal hygiene

The Food Code addresses controls for risk factors and further establishes 5 key public 

health interventions to protect consumer health. Specifically, these interventions are: 

demonstration of knowledge, employee health controls, controlling hands as a vehicle of 

contamination, time and temperature parameters for controlling pathogens, and the 

consumer advisory. The first two interventions are found in Chapter 2 and the last three 
FDA Food Code 2022 Preface

Preface - ii

in Chapter 3. 

The Food and Drug Administration (FDA) endeavors to assist the approximately 75 

state and territorial agencies and more than 3,000 local departments that assume 

primary responsibility for preventing foodborne illness and for licensing and inspecting 

establishments within the retail segment of the food industry. This industry segment 

consists of more than one million establishments and employs a work force of over 16 

million. 

2. PHS Model Codes History, Purpose, and Authority 

(A) History and Purpose

U.S. Public Health Service (PHS) activities in the area of food protection began at the 

turn of the 20th century with studies on the role of milk in the spread of disease. These 

studies led to the conclusion that effective disease prevention requires the application of 

comprehensive food sanitation measures from production to consumption. Additional 

studies identified and evaluated measures which would most effectively control disease, 

including work which led to improved processes for pasteurization.

Next, model codes were developed to assist state and local governments in initiating 

and maintaining effective programs for prevention of foodborne illness. The first of 

these, which is now titled Grade A Pasteurized Milk Ordinance – Recommendations of 

the PHS/FDA, was initially published in 1924. Subsequently, the PHS published 

recommended model food codes that address the various components of the retail 

segment of the food industry. These code editions are listed chronologically on pp. iii 

and iv. Through the years all states, hundreds of local jurisdictions, and many federal 

agencies have adopted some edition of model food codes recommended by the PHS. 

Today, FDA's purpose in maintaining an updated model food code is to assist food 

control jurisdictions at all levels of government by providing them with a scientifically 

sound technical and legal basis for regulating the retail segment of the food industry. 

The retail segment includes those establishments or locations in the food distribution 

chain where the consumer takes possession of the food. 

The model Food Code is neither federal law nor federal regulation and is not 

preemptive. Rather, it represents FDA's best advice for a uniform system of regulation 

to ensure that food at retail is safe and properly protected and presented. Although not 

federal requirements (until adopted by federal bodies for use within federal 

jurisdictions), the model Food Code provisions are designed to be consistent with 

federal food laws and regulations, and are written for ease of legal adoption at all levels 

of government. A list of jurisdictions that have reported to FDA their status in adopting 

the Food Code is available on the FDA CFSAN Web Page at: 

http://www.fda.gov/RetailFoodProtection. The list is self-reported and FDA has not yet 

evaluated whether all the adopted codes are equivalent to the model Food Code. 

Providing model food codes and model code interpretations and opinions is the 

mechanism through which FDA, as a lead federal food control agency, promotes 
FDA Food Code 2022 Preface

Preface - iii

uniform implementation of national food regulatory policy among the several thousand 

federal, state, and local agencies and tribes that have primary responsibility for the 

regulation or oversight of retail level food operations. 

(B) Authority

PHS authority for providing assistance to state and local governments is derived from 

the Public Health Service Act [42 USC 243]. Section 311(a) states in part:

"... The Secretary shall ... assist states and their political subdivisions in the 

prevention and suppression of communicable diseases, and with respect to other 

public health matters, shall cooperate with and aid state and local authorities in 

the enforcement of their ... health regulations and shall advise the several states 

on matters relating to the preservation and improvement of the public health." 

Responsibility for carrying out the provisions of the Act relative to food protection was 

delegated within the PHS to the Commissioner of Food and Drugs in 1968 [21 CFR 

5.10(a)(2) and (3)]. 

Under authority of the Economy Act, June 30, 1932 as amended [31 USC 1535], FDA 

provides assistance to federal agencies. 

Assistance provided to local, state, and federal governmental bodies is also based on 

FDA's authorities and responsibilities under the Federal Food, Drug, and Cosmetic Act 

[21 USC 301]. 

3. Public Health and Consumer Expectations

It is a shared responsibility of the food industry and the government to ensure that food 

provided to the consumer is safe and does not become a vehicle in a disease outbreak 

or in the transmission of communicable disease. This shared responsibility extends to 

ensuring that consumer expectations are met and that food is unadulterated, prepared 

in a clean environment, and honestly presented.

Under FDA’s 2018 Mission Statement the agency is responsible for:

Protecting the public health by assuring the safety of our nation’s food supply...and for 

advancing the public health by helping the public get accurate, science-based 

information they need about foods to maintain and improve their health.

Accordingly, the provisions of the Food Code provide a system of prevention and 

overlapping safeguards designed to minimize foodborne illness; ensure employee 

health, industry manager knowledge, safe food, nontoxic and cleanable equipment, and 

acceptable levels of sanitation on food establishment premises; and promote fair 

dealings with the consumer. 

4. Advantage of Uniform Standards

The advantages of well-written, scientifically sound, and up-to-date model codes have 
FDA Food Code 2022 Preface

Preface - iv

long been recognized by industry and government officials. 

Industry conformance with acceptable procedures and practices is far more likely where 

regulatory officials "speak with one voice" about what is required to protect the public 

health, why it is important, and which alternatives for compliance may be accepted.

Model codes provide a guide for use in establishing what is required. They are useful to 

business in that they provide accepted standards that can be applied in training and 

quality assurance programs. They are helpful to local, state, and federal governmental 

bodies that are developing or updating their own codes.

The model Food Code provides guidance on food safety, sanitation, and fair dealing 

that can be uniformly adopted for the retail segment of the food industry. The document 

is the cumulative result of the efforts and recommendations of many contributing 

individuals, agencies, and organizations with years of experience using earlier model 

code editions. It embraces the concept that our quality of life, state of health, and the 

public welfare are directly affected by how we collectively provide and protect our food. 

The model Food Code provisions are consistent with, and where appropriate 

incorporate, federal performance standards for the same products and processes. 

Federal performance standards in effect define public food safety expectations for the 

product, usually in terms of lethality to a pathogenic microorganism of particular 

concern. Use of performance standards as the measure of regulatory compliance 

means establishments are free to use innovative approaches in producing safe 

products, in lieu of adherence to traditional processing approaches, such as specified 

cooking times and temperatures, that achieve the same end. Federally inspected 

establishments demonstrate compliance with performance standards by showing that 

their process adheres to an appropriately designed, validated HACCP plan. 

Retail processors may be given the same opportunity as federally-regulated

establishments to use innovative techniques in the production of safe foods. Retail 

establishments may apply to the regulatory authority for a variance to use a specific 

federal food safety performance standard for a product or a process in lieu of 

compliance with otherwise applicable specifications in the Food Code. However, to 

show compliance with the federal performance standard, the retail processor must, like 

a federally inspected establishment, show that processing controls are in place to 

ensure that the standard is being met. Thus, a request for a variance based on a 

federal performance standard must be supported by a validated HACCP plan with 

record keeping and documented verification being made available to the regulatory 

authority. 

5. Modifications and Improvements In This Edition 

The revisions contained in this edition reflect changes, additions, deletions, and format 

modifications listed in the Supplement to the 2017 FDA Food Code and 

recommendations developed during the 2020 Biennial meeting of the Conference for 

Food Protection (held in August 2021). The revisions also reflect input provided by 
FDA Food Code 2022 Preface

Preface - v

those who have been intimately involved with studying, teaching, and using the earlier 

editions. Most of these enhancements involve added clarification or new information. 

Some reflect evolving regulatory policy contained in new or revised federal regulations.

Several of the Tables, Charts, and images were checked throughout the Code to ensure 

meeting web accessibility requirements under Section 508 of the Rehabilitation Act of 

1973 (29 U.S.C. 794d). Section 508 mandates that all federal agencies eliminate the 

barriers in accessing electronic and information technology. The law helps to ensure 

that members of the public with disabilities have the ability to access government 

information and services. 

The needed clarifications and missing Code provisions were identified by FDA and 

others during standardization and certification activities, State Training Team courses, 

regional food protection seminars, the deliberations of food equipment standards 

organizations, and the verbal and written requests for clarification received by FDA field 

and headquarters components. 

Changes in provisions related to federal laws and regulations administered by other 

federal agencies such as the United States Department of Agriculture were jointly 

developed with those agencies. 

A Summary of Changes is provided at the end of the Food Code. General 

enhancements include: 

1) Added and improved definitions that are more precise and more consistent with 

terminology and definitions found in related laws and regulations;

2) Modified provisions to make them more consistent with national requirements 

and standards administered by other federal agencies and international bodies;

more flexible without compromising public health; and more internally consistent 

with other Food Code provisions; 

3) Clarified other provisions regarding their intent, thereby reducing confusion and 

the potential for inconsistent application;

4) Improved user aids contained in the Annexes such as added references and 

updated public health reasons, model forms, guides, and lists; and

5) Expanded the Index with additional terms to assist a broader base of users in 

finding topics of interest. 

Some of the significant changes to the 2022 Food Code include:

1) Adding sesame as the ninth (9th) major food allergen;

2) Requiring written notification to consumers of major food allergens as ingredients 

in unpackaged food and labeling of major food allergens in bulk food that is 

available for consumer self-dispensing;
FDA Food Code 2022 Preface

Preface - vi 

3) Establishing new criteria for the donation of food to aid in public health protection;

4) Revising the definition of intact meat including enhancements to clarify 

time/temperature cooking requirements; and 

5) Creating new requirements for the allowance of pet dogs in outdoor dining 

spaces.

6. Discussion of the Code as a HACCP Model and the Intention to Incorporate 

Other Models

It is important to note that preapproval of HACCP plans for food establishments 

operating pursuant to a variance is provided for under the Food Code, but such a plan 

preapproval is not a part of another HACCP regulatory model, the Fish and Fishery 

Products regulation 21 CFR 123, effective December 18, 1997. FDA published the Fish 

and Fisheries Hazards and Controls Guidance Fourth Edition April 2011, with the most 

recent edition issued in June 2022. Additionally, there are differences between the two 

models in the required content of the HACCP plan. For example, the HACCP plans 

requested by the Food Code must include flow diagrams, product formulations, training 

plans, and a corrective action plan. Flow diagrams and product formulations are 

suggested but not mandated components of the Fish and Fishery Products regulation.

These differences are necessitated by differences in the nature of the regulations and 

the regulatory structure set up to enforce them. HACCP plans developed under the 

Food Code variance process are provided to the regulatory authority to enable the 

regulatory authority to assess whether the establishment has designed a system of 

controls sufficient to ensure the safety of the product. The plans will be reviewed 

outside the food establishment and, in most cases, in the absence of any historical 

performance information for the product at that establishment. Therefore, the plan must 

contain sufficient detail to allow the regulator to fully understand the operations and the 

intended controls. Products requiring a variance are those which are deemed to be 

time/temperature control for safety food and for which retail production would otherwise 

be prohibited. 

To assist food establishments in applying HACCP principles at retail, FDA has issued a 

document entitled: Managing Food Safety: A HACCP Principles Guide for Operators of 

Food Service, Retail Food Stores, and Other Food Establishments at the Retail Level. 

This document is available from FDA and can be found on the FDA Web Page at:

http://www.fda.gov/RetailFoodProtection. 

Under the Fish and Fishery Products regulation, every seafood processor is required to 

perform a hazard analysis, and must have and implement a written HACCP Plan 

whenever a hazard analysis reveals a food safety hazard that is reasonably likely to 

occur. HACCP plans developed pursuant to the Fish and Fishery Products regulation 

are for all products in the class and are not for products for which production is 

presently prohibited. Plans will be reviewed on site, with records available to judge, 

among other things, the adequacy of past corrective actions.
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Preface - vii

It is intended that the Food Code will be amended to incorporate federal HACCP 

regulations and guidelines by inclusion in the text of the Food Code, by reference, or 

through the issuance of interpretations. This will provide alternatives to the preapproval 

of HACCP plans, such as simplified HACCP plans in line with the Fish and Fishery 

Products model, if the product is produced under a HACCP plan developed in 

conformance with such regulation or guideline. In so doing, the need for preapproved 

plans under the more intensive regimen of the Food Code will be significantly reduced. 

HACCP plans are key to the use of performance standards as measures of regulatory 

compliance. Performance standards issued by the Food Safety and Inspection Service 

are applicable to a broad range of meat, poultry, and egg products. Federal 

performance standards are acceptable, equivalent alternatives to the command-andcontrol provisions that now provide specific times and temperatures for processing 

various products. Federal performance standards may be used to determine the safety 

of a product or process under the Food Code if authorized under a variance granted in 

accord with the Code’s variance provisions, and demonstrated by adherence to a 

validated HACCP plan, consistent with the Code’s HACCP provisions. 

7. Code Adoption/Certified Copies

The model Food Code is provided for use by food regulatory jurisdictions at all levels of 

government. At the state and local levels the model may be:

(A) Enacted into statute as an act of the state legislative body;

(B) Promulgated as a regulation, if the state legislative body has delegated rulemaking authority to a governmental administrative agency; or 

(C)Adopted as an ordinance, if the local legislative body has been delegated rulemaking authority or regulatory powers.

Typically, code adoption bodies publish a notice of their intent to adopt a code, make 

copies available for public inspection, and provide an opportunity for public input prior to 

adoption. This is usually done in one of two ways.

The recommended method is the "short form" or "adoption by reference" approach 

where a simple statement is published stating that certified copies of the proposed code 

are on file for public review. This approach may be used by governmental bodies

located in states that have enabling laws authorizing the adoption of codes by 

reference. An advantage to this approach is a substantial reduction in the cost of 

publishing and printing. 

Certified copies of the Food Code for use in adopting the model by reference are 

available through the FDA Retail Food Protection Staff, HFS-320, 5001 Campus Drive, 

College Park, MD 20740-3835. Refer to item 2. (A) of this Preface to access a listing of 

jurisdictions’ adoptions. 
FDA Food Code 2022 Preface

Preface - viii

The alternative method is the "long form" or "section-by-section" approach where the 

proposed code is published in its entirety. Both methods of adoption allow for the 

modification of specific provisions to accommodate existing law, administrative 

procedure, or regulatory policy. Annex 7 contains model adoption forms for use by 

governmental bodies who wish to use either of these methods. 

8. Information to Assist the User 

Many of the improvements contained in the model Food Code, as listed under item 5 of 

this Preface, are provided to make the document easier to use. Other characteristics of 

the new edition, if they are understood by the user, make it easier to follow and apply. 

These include structure, nomenclature, and methodology.

Food Code provisions address essentially four areas: personnel (Chapter 2), food 

(Chapter 3), equipment/facilities/supplies (Chapters 4, 5, 6, 7), and compliance and 

enforcement (Chapter 8). A new user will find it helpful to review the Table of Contents 

together with the Code Reference Sheet (Annex 7, Guide 3-B) in order to quickly gain

an understanding of the scope and sequence of subjects included within these four 

areas. 

The structural nomenclature of the document is as follows:

Chapter 9 

Part 9-1 

Subpart 9-101

Section (§) 9-101.11

Paragraph (¶) 9-101.11(A)

Subparagraph 9-101.11(A)(1)

Code provisions are either appropriate for citing and debiting on an inspection report or 

they are not. Those not intended for citing/debiting are identified by the digits following 

the decimal point in the numbering system. These “nondebitable” provisions fall into 

two categories, those that end with two digits after the decimal point and the last digit is 

a zero, e.g., § 1-201.10; and those that end with three digits after the decimal point and 

the last 2 digits are zeros, e.g., § 8-805.100. 

Two types of internal cross referencing are widely used throughout the Code to 

eliminate the need for restating provisions. 

A. The first type of cross reference uses phrases that contain the word “under”, e.g., 

“as specified under ... (followed by the relevant portion of the Code).” The 

purpose of this type of cross reference is to: 

1) Alert the reader to relevant information, and

2) Provide a system by which each violation is recorded under the one most

appropriate provision. This type of cross reference signals to the reader 

the provision of the Code under which a certain violation is properly 
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Preface - ix

cited/debited. 

B. The second type of cross reference uses phrases that contain the word “in,” e.g., 

“as specified in... (followed by the relevant portion of the Code).” The purpose of 

this type of cross reference is to:

1) Indicate the specific provisions of a separate document such as a federal 

regulation that are being incorporated by reference in the requirement of 

the Code, e.g., ¶ 3-201.11(C); or

2) Refer the reader to a nondebitable provision of the Code which provides 

further information for consideration, such as provision for an exception or 

for an allowance to comply via an alternative method.

For example, ¶ 3-201.16 (A) begins with “Except as specified in ¶ (B)...” 

and ¶ (B) states the relevant exceptions to ¶ (A). Paragraph 3-201.11(E) 

states in part, “... as specified in ¶ 3-401.11(C)” and ¶ 3-401.11(C) 

provides for an allowance to serve or sell raw or undercooked, wholemeat, intact beef steaks in a ready-to-eat form. 

If you review the exception in ¶ 3-201.16(B) and the allowance in ¶ 3-

401.11(C), you will see that exceptions and allowances often contain 

conditions of compliance, i.e., conditions that must be met in order for the 

exception or allowance to convey. 

Based on the violation being cited, the substance of the text being referred to, and the 

context in which the reference is made, users of the Code must infer the intent of the 

cross reference. That is, the user must determine if the cross reference simply alerts 

the user to additional information about the requirement or if the cross reference:

• Sends (via the word “under”) the citing/debiting to another Code provision; 

or 

• Incorporates (via the word “in”) the referenced requirements into the Code 

provision 

The Food Code presents requirements by principle rather than by subject. For 

example, equipment requirements are presented under headings such as Materials, 

Design and Construction, Numbers and Capacities, Location and Installation, and 

Maintenance and Operation rather than by refrigerators, sinks, and thermometers. In 

this way provisions need be stated only once rather than repeated for each piece or 

category of equipment. Where there are special requirements for certain equipment, 

the requirement is delineated under the appropriate principle (e.g., Design and 

Construction) and listed separately in the index. 

Portions of some sections are written in italics. These provisions are not requirements 
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Preface - x

but are provided to convey relevant information about specific exceptions and 

alternative means for compliance. Italics are pursuant to a preceding provision that 

states a requirement, to which the italics offer an exception or another possibility. 

Italicized sections usually involve the words “except for,” “may”, “need not” or “does not 

apply.” See ¶ 3-202.18(D).

The former use of “critical” or “non-critical” has been changed in recognition of the need 

to better identify risk-based controls within the Code’s provisions. Requirements 

contained in the Food Code are presented as being in one of three categories of 

importance: PRIORITY ITEM (i.e. a provision in this Code whose application contributes 

directly to the elimination, prevention or reduction to an acceptable level, hazards 

associated with foodborne illness or injury and there is no other provision that more 

directly controls the hazard); PRIORITY FOUNDATION ITEM (i.e., a provision in this 

Code whose application supports, facilitates or enables one or more PRIORITY 

ITEMS); and, CORE ITEM (i.e., a provision in this Code that is not designated as a 

PRIORITY ITEM or a PRIORITY FOUNDATION ITEM and that usually relates to 

general sanitation, operational controls, sanitation standard operating procedures 

(SSOPs), facilities or structures, equipment design, or general maintenance.

A “P” or “Pf” designation after a paragraph or subparagraph indicates that the provision 

within that section is a PRIORITY ITEM or PRIORITY FOUNDATION ITEM. Any unmarked 

provisions within a section are CORE ITEMS. 

The following conventions are used in the Food Code. “Shall” means the act is 

imperative, i.e., “shall” constitutes a command. “May not” means absolute prohibition. 

“May” is permissive and means the act is allowed. The term “means” is followed by a 

declared fact. 

Defined words and terms are in “small caps” in the text of the Food Code chapters to 

alert the reader to the fact that there is a specific meaning assigned to those words and 

terms and that the meaning of a provision is to be interpreted in the defined context. A 

concerted effort was also made to place in “small caps” all forms and combinations of 

those defined words and terms that were intended to carry the weight of the definition. 

The annexes located at the back of the document can provide tremendous assistance 

to those charged with applying Food Code provisions. No reference is made in the text 

of a provision to the annexes which support its requirements. This is necessary in order 

to keep future laws or other requirements based on the model Food Code "clean." 

However, the annexes are provided specifically to assist the regulatory authority apply 

the provisions uniformly and effectively. 

It is, therefore, important for users to preview the subject and essence of each of the 

annexes before using the document. Some of the annexes (e.g., References, Public 

Health Reasons) are structured to present the information by the specific Food Code 

item number to which they apply. Other annexes provide information and materials 

intended to be helpful to the user such as model forms that can be used, a delineation 

of the principles of HACCP, guidelines for establishment inspection, and criteria for 
FDA Food Code 2022 Preface

Preface - xi

certain food processes for use in evaluating proposed HACCP plans. 

9. The Code Revision Process

(A) Food Code Revision and Publication Cycles

FDA is issuing a new edition of the Food Code every 4 years. During the 4-year span of 

time between editions, FDA may issue supplements to an existing edition. Each new 

edition will incorporate the changes made in the supplement as well as any new 

revisions. 

A change in the Code’s release cycle occurred ahead of the planned 2021 Food Code 

release. The FDA values the input of all retail food stakeholder groups through the 

Conference for Food Protection (CFP) and with the occurrence of the COVID-19 

pandemic, the CFP changed to an odd-year meeting cycle. With this change, and to

allow for stakeholder input into the Code, FDA adjusted the Food Code release cycle to 

be on an even-year cycle going forward. This 2022 full edition reflects that change.

(B) Submission of Food Code Change Suggestions

FDA will continue to receive concerns and recommendations for modification of the 

Food Code from any individual or organization. 

Given the purpose of the document as discussed in item 2 of this Preface, the Agency 

will be especially interested in addressing problems identified by those in government 

and industry who are responsible for implementing the Food Code. FDA will also be 

especially responsive to those needed policy and technical changes raised by an 

organization that uses a democratic process for addressing problems and concerns. 

Included are organizations that provide a process that encourages representative 

participation in deliberations by government, industry, and academic and consumer 

interests, followed by public health ratification such as a state-by-state vote by officially 

designated delegates. The Conference for Food Protection (retail food issues), the 

National Conference on Interstate Milk Shipments (milk and dairy products issues), and 

the Interstate Shellfish Sanitation Conference (molluscan shellfish issues) are examples 

of such organizations. These organizations receive problems submitted by any 

interested individual, but specify the forms on which the issues must be detailed and 

provide specific time frames during which they may be submitted. 

FDA encourages interested individuals to consider raising issues and suggesting 

solutions involving the federal-state cooperative programs based on FDA's model codes 

through these organizations. 

10. Acknowledgments

Many individuals devoted considerable time and effort in addressing concerns and 

developing recommendations that are now reflected in the Food Code. These 

individuals represent a wide diversity of regulators, educators, industry leaders, and 
FDA Food Code 2022 Preface

Preface - xii

consumer representatives acting through their agencies, companies, professional 

groups, or trade organizations. It is only through the dedicated efforts and contributions 

of experienced professionals that a scientifically sound, well focused, and up-to-date 

model code is possible. FDA acknowledges with gratitude the substantial assistance of 

those who contributed to public health and food safety in the development of the Food 

Code. 
FDA Food Code List of Chapters, Parts and Subparts

List of Chapters, Parts, and Subparts - 1

Chapters, Parts, and 

Subparts

CHAPTER 1 PURPOSE AND DEFINITIONS................................................................1

1-1 TITLE, INTENT, SCOPE .............................................................................................1

1-101 Title ...............................................................................................................1

1-102 Intent.............................................................................................................1

1-103 Scope............................................................................................................1

1-2 DEFINITIONS ...........................................................................................................1

1-201 Applicability and Terms Defined....................................................................1

CHAPTER 2 MANAGEMENT AND PERSONNEL........................................................1

2-1 SUPERVISION..........................................................................................................1

2-101 Responsibility................................................................................................1

2-102 Knowledge ....................................................................................................1

2-103 Duties............................................................................................................4

2-2 EMPLOYEE HEALTH .................................................................................................6

2-201 Responsibilities of Permit Holder, Person in Charge, Food Employees, and 

Conditional Employees ...........................................................................................6

2-3 PERSONAL CLEANLINESS.......................................................................................18

2-301 Hands and Arms .........................................................................................18

2-302 Fingernails ..................................................................................................20

2-303 Jewelry........................................................................................................20

2-304 Outer Clothing.............................................................................................21

2-4 HYGIENIC PRACTICES............................................................................................21

2-401 Food Contamination Prevention..................................................................21

2-402 Hair Restraints ............................................................................................21

2-403 Animals .......................................................................................................22

2-5 RESPONDING TO CONTAMINATION EVENTS .............................................................22

CHAPTER 3 FOOD........................................................................................................1

3-1 CHARACTERISTICS..................................................................................................1

3-101 Condition.......................................................................................................1

3-2 SOURCES, SPECIFICATIONS, AND ORIGINAL CONTAINERS AND RECORDS....................1

3-201 Sources.........................................................................................................1

3-202 Specifications for Receiving..........................................................................4

3-203 Original Containers and Records ..................................................................6

3-204 Food Donation ..............................................................................................8

3-3 PROTECTION FROM CONTAMINATION AFTER RECEIVING............................................8
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List of Chapters, Parts, and Subparts - 2

3-301 Preventing Contamination by Employees .....................................................8

3-302 Preventing food and ingredient contamination............................................10

3-303 Preventing Contamination from Ice Used As a Coolant ..............................12

3-304 Preventing Contamination from Equipment, Utensils, and Linens ..............13

3-305 Preventing contamination from the premises..............................................16

3-306 Preventing contamination by consumers ....................................................17

3-307 Preventing Contamination from Other Sources...........................................18

3-4 DESTRUCTION OF ORGANISMS OF PUBLIC HEALTH CONCERN ..................................18

3-401 Cooking.......................................................................................................18

3-402 Freezing......................................................................................................23

3-403 Reheating....................................................................................................24

3-404 Other Methods ............................................................................................25

3-5 LIMITATION OF GROWTH OF ORGANISMS OF PUBLIC HEALTH CONCERN ....................25

3-501 Temperature and Time Control...................................................................25

3-502 Specialized Processing Methods ................................................................32

3-6 FOOD IDENTITY, PRESENTATION, AND ON-PREMISES LABELING ...............................36

3-601 Accurate Representation ............................................................................36

3-602 Labeling ......................................................................................................37

3-603 Consumer Advisory.....................................................................................38

3-7 CONTAMINATED FOOD ..........................................................................................39

3-307 Disposition ..................................................................................................39

3-8 SPECIAL REQUIREMENTS FOR HIGHLY SUSCEPTIBLE POPULATIONS .........................39

3-801 Additional Safeguards.................................................................................39

CHAPTER 4 EQUIPMENT, UTENSILS, AND LINENS .................................................1

4-1 MATERIALS FOR CONSTRUCTION AND REPAIR...........................................................1

4-101 Multiuse.........................................................................................................1

4-2 DESIGN AND CONSTRUCTION...................................................................................4

4-201 Durability and Strength .................................................................................4

4-202 Cleanability ...................................................................................................4

4-203 Accuracy .......................................................................................................5

4-204 Functionality..................................................................................................6

4-205 Acceptability................................................................................................12

4-3 NUMBERS AND CAPACITIES ...................................................................................12

4-301 Equipment...................................................................................................12

4-302 Utensils, Temperature Measuring Devices, and Testing Devices ...............13

4-303 Cleaning Agents and Sanitizers ..................................................................14

4-4 LOCATION AND INSTALLATION ................................................................................14

4-401 Location ......................................................................................................14

4-402 Installation...................................................................................................15

4-5 MAINTENANCE AND OPERATION.............................................................................16

4-501 Equipment...................................................................................................16

4-502 Utensils and Temperature and Pressure Measuring Devices .....................20

4-6 CLEANING OF EQUIPMENT AND UTENSILS ...............................................................20

4-601 Objective.....................................................................................................20
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List of Chapters, Parts, and Subparts - 3

4-602 Frequency...................................................................................................21

4-603 Methods ......................................................................................................23

4-7 SANITIZATION OF EQUIPMENT AND UTENSILS ..........................................................25

4-701 Objective.....................................................................................................25

4-702 Frequency...................................................................................................25

4-703 Methods ......................................................................................................25

4-8 LAUNDERING........................................................................................................26

4-801 Objective.....................................................................................................26

4-802 Frequency...................................................................................................26

4-803 Methods ......................................................................................................26

4-9 PROTECTION OF CLEAN ITEMS...............................................................................27

4-901 Drying .........................................................................................................27

4-902 Lubricating and Reassembling....................................................................27

4-903 Storing.........................................................................................................28

4-904 Preventing Contamination...........................................................................29

CHAPTER 5 WATER, PLUMBING, AND WASTE ........................................................1

5-1 WATER..................................................................................................................1

5-101 Source ..........................................................................................................1

5-102 Quality...........................................................................................................1

5-103 Quantity and Availability................................................................................2

5-104 Distribution, Delivery, and Retention.............................................................2

5-2 PLUMBING SYSTEM.................................................................................................3

5-201 Materials .......................................................................................................3

5-202 Design, Construction, and Installation...........................................................3

5-203 Numbers and Capacities...............................................................................4

5-204 Location and Placement ...............................................................................5

5-205 Operation and Maintenance..........................................................................5

5-3 MOBILE WATER TANK AND MOBILE FOOD ESTABLISHMENT WATER TANK ...................6

5-301 Materials .......................................................................................................6

5-302 Design and Construction...............................................................................6

5-303 Numbers and Capacities...............................................................................7

5-304 Operation and Maintenance..........................................................................8

5-4 SEWAGE, OTHER LIQUID WASTE, AND RAINWATER ...................................................9

5-401 Mobile Holding Tank .....................................................................................9

5-402 Retention, Drainage, and Delivery ................................................................9

5-403 Disposal Facility ..........................................................................................10

5-5 REFUSE, RECYCLABLES, AND RETURNABLES..........................................................10

5-501 Facilities on the Premises ...........................................................................10

5-502 Removal......................................................................................................13

5-503 Facilities for Disposal and Recycling...........................................................13

CHAPTER 6 PHYSICAL FACILITIES ...........................................................................1

6-1 MATERIALS FOR CONSTRUCTION AND REPAIR ...........................................................1

6-101 Indoor Areas .................................................................................................1
FDA Food Code List of Chapters, Parts and Subparts

List of Chapters, Parts, and Subparts - 4

6-102 Outdoor Areas...............................................................................................1

6-2 DESIGN, CONSTRUCTION, AND INSTALLATION ............................................................2

6-201 Cleanability ...................................................................................................2

6-202 Functionality..................................................................................................3

6-3 NUMBERS AND CAPACITIES ......................................................................................5

6-301 Handwashing Sinks ......................................................................................5

6-302 Toilets and Urinals ........................................................................................6

6-303 Lighting .........................................................................................................6

6-304 Ventilation .....................................................................................................7

6-305 Dressing Areas and Lockers.........................................................................7

6-306 Service Sinks ................................................................................................7

6-4 LOCATION AND PLACEMENT .....................................................................................7

6-401 Handwashing Sinks ......................................................................................7

6-402 Toilet Rooms.................................................................................................7

6-403 Employee Accommodations..........................................................................8

6-404 Distressed Merchandise ...............................................................................8

6-405 Refuse, Recyclables, and Returnables .........................................................8

6-5 MAINTENANCE AND OPERATION................................................................................8

6-501 Premises, Structures, Attachments, and Fixtures - Methods ........................8

CHAPTER 7 POISONOUS OR TOXIC MATERIALS ....................................................1

7-1 LABELING AND IDENTIFICATION ................................................................................1

7-101 Original Containers .......................................................................................1

7-102 Working Containers ......................................................................................1

7-2 OPERATIONAL SUPPLIES AND APPLICATIONS ............................................................1

7-201 Storage .........................................................................................................1

7-202 Presence and Use ........................................................................................2

7-203 Container Prohibitions...................................................................................3

7-204 Chemicals .....................................................................................................3

7-205 Lubricants .....................................................................................................4

7-206 Pesticides......................................................................................................4

7-207 Medicines......................................................................................................5

7-208 First Aid Supplies ..........................................................................................5

7-209 Other Personal Care Items ...........................................................................5

7-3 STOCK AND RETAIL SALE ........................................................................................5

CHAPTER 8 COMPLIANCE AND ENFORCEMENT.....................................................1

8-1 CODE APPLICABILITY ..............................................................................................1

8-101 Use for Intended Purpose .............................................................................1

8-102 Additional Requirements...............................................................................1

8-103 Variances......................................................................................................2

8-2 PLAN SUBMISSION AND APPROVAL...........................................................................3

8-201 Facility and Operating Plans .........................................................................3

8-202 Confidentiality ...............................................................................................5

8-203 Construction Inspection and Approval ..........................................................5
FDA Food Code List of Chapters, Parts and Subparts

List of Chapters, Parts, and Subparts - 5

8-3 PERMIT TO OPERATE ..............................................................................................5

8-301 Requirement .................................................................................................5

8-302 Application Procedure...................................................................................5

8-303 Issuance........................................................................................................7

8-304 Conditions of Retention.................................................................................8

8-4 INSPECTION AND CORRECTION OF VIOLATIONS .......................................................10

8-401 Frequency...................................................................................................10

8-402 Competency and Access ............................................................................11

402.11 Allowed at Reasonable Times after Due Notice.......................................11

8-403 Report of Findings.......................................................................................12

8-404 Imminent Health Hazard .............................................................................13

8-405 Violation of Priority Item or Priority Foundatio Item .....................................14

8-406 Core Item Violation .....................................................................................14

8-5 PREVENTION OF FOODBORNE DISEASE TRANSMISSION BY EMPLOYEES....................15

8-501 Investigation and Control ............................................................................15

Annexes
FDA Food Code 2022 Chapter 1. Purpose and Definitions

Chapter 1 - 1

Chapter 1 Purpose and 

Definitions

Parts:

1-1 Title, Intent, Scope

1-2 Definitions

1-1 Title, Intent, Scope

1-101 Title

1-101.10 Food Code.

These provisions shall be known as the Food Code, hereinafter referred to as 

"this Code."

1-102 Intent

1-102.10 Food Safety, Illness Prevention, and Honest Presentation.

The purpose of this Code is to safeguard public health and provide to 

CONSUMERS FOOD that is safe, unADULTERATED, and honestly presented.

1-103 Scope

1-103.10 Statement.

This Code establishes definitions; sets standards for management and 

personnel, FOOD operations, and EQUIPMENT and facilities; and provides for FOOD

ESTABLISHMENT plan review, PERMIT issuance, inspection, EMPLOYEE RESTRICTION, 

and PERMIT suspension.

1-2 Definitions

1-201 Applicability and Terms Defined

1-201.10 Statement of Application and Listing of Terms.

(A) The following definitions shall apply in the interpretation and application of 

this Code.

(B) Terms Defined. As used in this Code, each of the terms listed in 

¶1-201.10(B) shall have the meaning stated below.

Accredited Program.

(1) "Accredited program" means a food protection manager 

certification program that has been evaluated and listed by an 
FDA Food Code 2022 Chapter 1. Purpose and Definitions

Chapter 1 - 2

accrediting agency as conforming to national standards for 

organizations that certify individuals. 

(2) "Accredited program" refers to the certification process and 

is a designation based upon an independent evaluation of factors 

such as the sponsor's mission; organizational structure; staff 

resources; revenue sources; policies; public information regarding 

program scope, eligibility requirements, re-certification, discipline 

and grievance procedures; and test development and 

administration. 

(3) "Accredited program" does not refer to training functions or 

educational programs.

Additive.

(1) "Food additive" has the meaning stated in the Federal Food, 

Drug, and Cosmetic Act, § 201(s) and 21 CFR 170.3(e)(1).

(2) "Color additive" has the meaning stated in the Federal Food, 

Drug, and Cosmetic Act, § 201(t) and 21 CFR 70.3(f).

"Adulterated" has the meaning stated in the Federal Food, Drug, and 

Cosmetic Act, § 402.

"Approved" means acceptable to the REGULATORY AUTHORITY based on a 

determination of conformity with principles, practices, and generally 

recognized standards that protect public health.

Asymptomatic.

(1) "Asymptomatic" means without obvious symptoms; not 

showing or producing indications of a disease or other medical 

condition, such as an individual infected with a pathogen but not 

exhibiting or producing any signs or symptoms of vomiting, 

diarrhea, or jaundice.

(2) "Asymptomatic" includes not showing symptoms because 

symptoms have resolved or subsided, or because symptoms never 

manifested. 

"aw" means water activity which is a measure of the free moisture in a 

FOOD, is the quotient of the water vapor pressure of the substance divided 

by the vapor pressure of pure water at the same temperature, and is 

indicated by the symbol AW.

"Balut" means an embryo inside a fertile EGG that has been incubated for 

a period sufficient for the embryo to reach a specific stage of 

development after which it is removed from incubation before hatching.

"Beverage" means a liquid for drinking, including water.
FDA Food Code 2022 Chapter 1. Purpose and Definitions

Chapter 1 - 3

"Bottled drinking water" means water that is SEALED in bottles, 

packages, or other containers and offered for sale for human 

consumption, including bottled mineral water.

"Casing" means a tubular container for sausage products made of either 

natural or artificial (synthetic) material.

"Certification number" means the unique identification number issued 

by the SHELLFISH CONTROL AUTHORITY to each dealer for each location. 

Each certification number shall consist to a one-to-five digit Arabic 

number preceded by the two letter State abbreviation and followed by a 

two-letter abbreviation for the type of activity or activities the dealer is 

qualified to perform in accordance with this provision of the National 

Shellfish Sanitation Program using the terms in the following tables:

 Table A. Certifications

ACRONYM TERM

SP Shucker Packer

RP Repacker

SS SHELLSTOCK

Shipper

RS Reshipper

DP Depuration

Table B. Permits

ACRONYM TERM

PHP Post-Harvest 

Processing

AQ Aquaculture

WS Wet Storage

"CFR" means CODE OF FEDERAL REGULATIONS. Citations in this Code to 

the CFR refer sequentially to the Title, Part, and Section numbers, such as 

40 CFR 180.194 refers to Title 40, Part 180, Section 194.

CIP.

(1) "CIP" means cleaned in place by the circulation or flowing by 

mechanical means through a piping system of a detergent solution, 

water rinse, and SANITIZING solution onto or over EQUIPMENT

surfaces that require cleaning, such as the method used, in part, to 

clean and SANITIZE a frozen dessert machine. 

(2) "CIP" does not include the cleaning of EQUIPMENT such as band 

saws, slicers, or mixers that are subjected to in-place manual 

cleaning without the use of a CIP system.

"Commingle" means the act of combining different lots of shellfish.

Comminuted. 

(1) "Comminuted" means reduced in size by methods including 

chopping, flaking, grinding, or mincing. 
FDA Food Code 2022 Chapter 1. Purpose and Definitions

Chapter 1 - 4

(2) "Comminuted" includes FISH or MEAT products that are reduced 

in size and restructured or reformulated such as gefilte FISH, gyros, 

ground beef, and sausage; and a mixture of 2 or more types of MEAT

that have been reduced in size and combined, such as sausages 

made from 2 or more MEATS. 

"Conditional employee" means a potential FOOD EMPLOYEE to whom a 

job offer is made, conditional on responses to subsequent medical 

questions or examinations designed to identify potential FOOD EMPLOYEES

who may be suffering from a disease that can be transmitted through 

FOOD and done in compliance with Title 1 of the Americans with 

Disabilities Act of 1990. 

"Confirmed disease outbreak" means a foodborne disease outbreak in 

which laboratory analysis of appropriate specimens identifies a causative 

agent and epidemiological analysis implicates the food as the source of 

the illness. 

"Consumer" means a person who is a member of the public, takes 

possession of food, is not functioning in the capacity of an operator of a 

food establishment or food processing plant, and does not offer the food 

for resale. 

Core Item. 

(1) "Core item" means a provision in this Code that is not 

designated as a PRIORITY ITEM or a PRIORITY FOUNDATION ITEM.

(2) "Core item" includes an item that usually relates to general 

sanitation, operational controls, sanitation standard operating 

procedures (SSOPs), facilities or structures, equipment design, or 

general maintenance. 

"Corrosion-resistant material" means a material that maintains 

acceptable surface cleanability characteristics under prolonged influence 

of the FOOD to be contacted, the normal use of cleaning compounds and 

SANITIZING solutions, and other conditions of the use environment. 

"Counter-mounted equipment" means EQUIPMENT that is not portable 

and is designed to be mounted off the floor on a table, counter, or shelf. 

"Critical control point" means a point or procedure in a specific FOOD

system where loss of control may result in an unacceptable health RISK. 

"Critical limit" means the maximum or minimum value to which a 

physical, biological, or chemical parameter must be controlled at a 

CRITICAL CONTROL POINT to minimize the RISK that the identified FOOD safety 

HAZARD may occur.

“Cut leafy greens” means fresh leafy greens whose leaves have been 

cut, shredded, sliced, chopped, or torn. The term “leafy greens” includes 

iceberg lettuce, romaine lettuce, leaf lettuce, butter lettuce, baby leaf 
FDA Food Code 2022 Chapter 1. Purpose and Definitions

Chapter 1 - 5

lettuce (i.e., immature lettuce or leafy greens), escarole, endive, spring 

mix, spinach, cabbage, kale, arugula and chard. The term “leafy greens” 

does not include herbs such as cilantro or parsley.

"Dealer" means a PERSON who is authorized by a SHELLFISH CONTROL 

AUTHORITY for the activities of SHELLSTOCK shipper, shucker-packer, 

repacker, reshipper, or depuration processor of MOLLUSCAN SHELLFISH

according to the provisions of the National Shellfish Sanitation Program.

"Disclosure" means a written statement that clearly identifies the animalderived FOODS which are, or can be ordered, raw, undercooked, or without 

otherwise being processed to eliminate pathogens, or items that contain 

an ingredient that is raw, undercooked, or without otherwise being 

processed to eliminate pathogens. 

Drinking Water.

(1) "Drinking water" means water that meets criteria as specified 

in 40 CFR 141 National Primary Drinking Water Regulations. 

(2) "Drinking water" is traditionally known as "potable water." 

(3) "Drinking water" includes the term "water" except where the 

term used connotes that the water is not potable, such as "boiler 

water," "mop water," "rainwater," "wastewater," and "nondrinking" 

water. 

"Dry storage area" means a room or area designated for the storage of 

PACKAGED or containerized bulk FOOD that is not TIME/TEMPERATURE 

CONTROL FOR SAFETY FOOD and dry goods such as SINGLE-SERVICE items.

Easily Cleanable.

(1) "Easily cleanable" means a characteristic of a surface that: 

(a) Allows effective removal of soil by normal cleaning 

methods;

(b) Is dependent on the material, design, construction, and 

installation of the surface; and 

(c) Varies with the likelihood of the surface's role in 

introducing pathogenic or toxigenic agents or other 

contaminants into FOOD based on the surface's APPROVED

placement, purpose, and use.

(2) "Easily cleanable" includes a tiered application of the criteria 

that qualify the surface as EASILY CLEANABLE as specified in 

Subparagraph (1) of this definition to different situations in which 

varying degrees of cleanability are required such as: 

(a) The appropriateness of stainless steel for a FOOD

preparation surface as opposed to the lack of need for 
FDA Food Code 2022 Chapter 1. Purpose and Definitions

Chapter 1 - 6

stainless steel to be used for floors or for tables used for 

CONSUMER dining; or 

(b) The need for a different degree of cleanability for a 

utilitarian attachment or accessory in the kitchen as opposed 

to a decorative attachment or accessory in the CONSUMER

dining area. 

"Easily movable" means: 

(1) Portable; mounted on casters, gliders, or rollers; or provided with 

a mechanical means to safely tilt a unit of EQUIPMENT for cleaning; 

and

(2) Having no utility connection, a utility connection that disconnects 

quickly, or a flexible utility connection line of sufficient length to 

allow the EQUIPMENT to be moved for cleaning of the EQUIPMENT and 

adjacent area. 

Egg.

(1) "Egg" means the shell EGG of avian species such as chicken, 

duck, goose, guinea, quail, RATITES or turkey. 

(2) "Egg" does not include:

(a) A balut;

(b) The egg of reptile species such as alligator; or

(c) An egg product. 

Egg Product. 

(1) "Egg Product" means all, or a portion of, the contents found 

inside EGGS separated from the shell and pasteurized in a FOOD 

PROCESSING PLANT, with or without added ingredients, intended for 

human consumption, such as dried, frozen or liquid eggs. 

(2) "Egg Product" does not include FOOD which contains EGGS only 

in a relatively small proportion such as cake mixes.

"Employee" means the PERMIT HOLDER, PERSON IN CHARGE, FOOD 

EMPLOYEE, PERSON having supervisory or management duties, PERSON on 

the payroll, family member, volunteer, PERSON performing work under 

contractual agreement, or other PERSON working in a FOOD ESTABLISHMENT. 

"EPA" means the U.S. Environmental Protection Agency.

Equipment.

(1) "Equipment" means an article that is used in the operation of a 

FOOD ESTABLISHMENT such as a freezer, grinder, hood, ice maker, 

MEAT block, mixer, oven, reach-in refrigerator, scale, sink, slicer, 

stove, table, TEMPERATURE MEASURING DEVICE for ambient air, 

VENDING MACHINE, or WAREWASHING machine. 
FDA Food Code 2022 Chapter 1. Purpose and Definitions

Chapter 1 - 7

(2) "Equipment" does not include apparatuses used for handling or 

storing large quantities of PACKAGED FOODS that are received from a 

supplier in a cased or overwrapped lot, such as hand trucks, 

forklifts, dollies, pallets, racks, and skids.

"Exclude" means to prevent a PERSON from working as an EMPLOYEE in a 

FOOD ESTABLISHMENT or entering a FOOD ESTABLISHMENT as an EMPLOYEE. 

"FDA" means the U.S. Food and Drug Administration.

Fish.

(1) "Fish" means fresh or saltwater finfish, crustaceans and other 

forms of aquatic life (including alligator, frog, aquatic turtle, jellyfish, 

sea cucumber, and sea urchin and the roe of such animals) other 

than birds or mammals, and all mollusks, if such animal life is 

intended for human consumption. 

(2) "Fish" includes an edible human FOOD product derived in whole 

or in part from FISH, including FISH that have been processed in any 

manner.

"Food" means a raw, cooked, or processed edible substance, ice, 

BEVERAGE, or ingredient used or intended for use or for sale in whole or in 

part for human consumption, or chewing gum. 

"Foodborne disease outbreak" means the occurrence of two or more 

cases of a similar illness resulting from the ingestion of a common FOOD. 

"Food-contact surface" means:

(1) A surface of EQUIPMENT or a UTENSIL with which FOOD normally 

comes into contact; or

(2) A surface of EQUIPMENT or a UTENSIL from which FOOD may drain, 

drip, or splash:

(a) Into a FOOD, or

(b) Onto a surface normally in contact with FOOD. 

"Food employee" means an individual working with unPACKAGED FOOD, 

FOOD EQUIPMENT or UTENSILS, or FOOD-CONTACT SURFACES. 

Food Establishment. 

(1) "Food establishment" means an operation that:

(a) stores, prepares, packages, serves, vends FOOD directly 

to the CONSUMER, or otherwise provides FOOD for human 

consumption such as a restaurant; satellite or catered 

feeding location; catering operation if the operation provides 

FOOD directly to a CONSUMER or to a conveyance used to 

transport people; market; vending location; conveyance used 

to transport people; institution; or FOOD bank; and 
FDA Food Code 2022 Chapter 1. Purpose and Definitions

Chapter 1 - 8

(b) relinquishes possession of FOOD to a CONSUMER directly, 

or indirectly through a delivery service such as home 

delivery of grocery orders or restaurant takeout orders, or 

delivery service that is provided by common carriers. 

(2) "Food establishment" includes: 

(a) An element of the operation such as a transportation 

vehicle or a central preparation facility that supplies a 

vending location or satellite feeding location unless the 

vending or feeding location is permitted by the REGULATORY 

AUTHORITY; and 

(b) An operation that is conducted in a mobile, stationary, 

temporary, or permanent facility or location; where 

consumption is on or off the PREMISES; and regardless of 

whether there is a charge for the FOOD. 

(3) "Food establishment" does not include:

(a) An establishment that offers only prePACKAGED FOODS

that are not TIME/TEMPERATURE CONTROL FOR SAFETY FOODS;

(b) A produce stand that only offers whole, uncut fresh fruits 

and vegetables;

(c) A FOOD PROCESSING PLANT; including those that are 

located on the PREMISES of a FOOD ESTABLISHMENT;

(d) A kitchen in a private home if only FOOD that is not 

TIME/TEMPERATURE CONTROL FOR SAFETY FOOD, is prepared for 

sale or service at a function such as a religious or charitable 

organization’s bake sale if allowed by LAW and if the 

CONSUMER is informed by a clearly visible placard at the 

sales or service location that the FOOD is prepared in a 

kitchen that is not subject to regulation and inspection by the 

REGULATORY AUTHORITY;

(e) An area where FOOD that is prepared as specified in 

Subparagraph (3)(d) of this definition is sold or offered for 

human consumption; 

(f) A kitchen in a private home, such as a small family daycare provider; or a bed-and-breakfast operation that 

prepares and offers FOOD to guests if the home is owner 

occupied, the number of available guest bedrooms does not 

exceed 6, breakfast is the only meal offered, the number of 

guests served does not exceed 18, and the CONSUMER is 

informed by statements contained in published 

advertisements, mailed brochures, and placards posted at 

the registration area that the FOOD is prepared in a kitchen 
FDA Food Code 2022 Chapter 1. Purpose and Definitions

Chapter 1 - 9

that is not regulated and inspected by the REGULATORY 

AUTHORITY; or

(g) A private home that receives catered or home-delivered 

FOOD.

Food Processing Plant.

(1) "Food processing plant" means a commercial operation that 

manufactures, packages, labels, or stores FOOD for human 

consumption, and provides FOOD for sale or distribution to other 

business entities such as FOOD PROCESSING PLANTS or FOOD 

ESTABLISHMENTS. 

(2) "Food processing plant" does not include a FOOD 

ESTABLISHMENT.

Game Animal. 

(1) "Game animal" means an animal, the products of which are 

FOOD, that is not classified as livestock, sheep, swine, goat, horse, 

mule, or other equine in 9 CFR 301.2 Definitions, or as Poultry, or 

FISH.

(2) "Game animal" includes mammals such as reindeer, elk, deer, 

antelope, water buffalo, bison, rabbit, squirrel, opossum, raccoon, 

nutria, or muskrat, and nonaquatic reptiles such as land snakes.

(3) "Game animal" does not include ratites.

"General use pesticide" means a pesticide that is not classified by EPA 

for restricted use as specified in 40 CFR 152.175 Pesticides classified for 

restricted use.

"Grade A standards" means the requirements of the United States 

Public Health Service/FDA "Grade A Pasteurized Milk Ordinance" with 

which certain fluid and dry milk and milk products comply. 

"HACCP plan" means a written document that delineates the formal 

procedures for following the HAZARD Analysis and CRITICAL CONTROL POINT

principles developed by The National Advisory Committee on 

Microbiological Criteria for Foods. 

Handwashing Sink.

(1) "Handwashing sink" means a lavatory, a basin or vessel for 

washing, a wash basin, or a plumbing fixture especially placed for 

use in personal hygiene and designed for the washing of the hands.

(2) "Handwashing sink" includes an automatic handwashing 

facility. 

"Hazard" means a biological, chemical, or physical property that may 

cause an unacceptable CONSUMER health RISK. 
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"Health practitioner" means a physician licensed to practice medicine, or 

if allowed by LAW, a nurse practitioner, physician assistant, or similar 

medical professional. 

"Hermetically sealed container" means a container that is designed and 

intended to be secure against the entry of microorganisms and, in the 

case of low acid canned FOODS, to maintain the commercial sterility of its 

contents after processing. 

"Highly susceptible population" means PERSONS who are more likely 

than other people in the general population to experience foodborne 

disease because they are: 

(1) Immunocompromised; preschool age children, or older adults; 

and 

(2) Obtaining FOOD at a facility that provides services such as 

custodial care, health care, or assisted living, such as a child or 

adult day care center, kidney dialysis center, hospital or nursing 

home, or nutritional or socialization services such as a senior 

center.

"Imminent health hazard" means a significant threat or danger to health 

that is considered to exist when there is evidence sufficient to show that a 

product, practice, circumstance, or event creates a situation that requires 

immediate correction or cessation of operation to prevent injury based on: 

(1) The number of potential injuries, and

(2) The nature, severity, and duration of the anticipated injury.

"Injected" means manipulating MEAT to which a solution has been 

introduced into its interior by processes that are referred to as "injecting," 

“pump marinating,” or "stitch pumping”.

“In-Shell Product” means non-living, processed shellfish with one or both 

shells present.

“Intact Meat” means a cut of whole muscle(s) MEAT that has not 

undergone COMMINUTION, MECHANICAL TENDERIZATION, vacuum tumbling 

with solutions, reconstruction, cubing or pounding.

Juice.

(1) "Juice" means the aqueous liquid expressed or extracted from 

one or more fruits or vegetables, purées of the edible portions of 

one or more fruits or vegetables, or any concentrates of such liquid 

or purée. 

(2) "Juice" does not include, for purposes of HACCP, liquids, 

purées, or concentrates that are not used as BEVERAGES or 

ingredients of BEVERAGES.

"Kitchenware" means FOOD preparation and storage UTENSILS. 
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"Law" means applicable local, state, and federal statutes, regulations, 

and ordinances. 

"Linens" means fabric items such as cloth hampers, cloth napkins, table 

cloths, wiping cloths, and work garments including cloth gloves.

Major Food Allergen.

(1) "Major food allergen" means:

(a) Milk, EGG, FISH (such as bass, flounder, cod, and 

including crustacean shellfish such as crab, lobster, or 

shrimp), tree nuts (such as almonds, pecans, or walnuts), 

wheat, peanuts, soybeans and sesame; or

b) A FOOD ingredient that contains protein derived from a 

FOOD, as specified in Subparagraph (1)(a) of this definition.

(2) "Major food allergen" does not include:

(a) Any highly refined oil derived from a food specified in 

Subparagraph (1)(a) of this definition and any ingredient 

derived from such highly refined oil; or

(b) Any ingredient that is exempt under the petition or 

notification process specified in the Food Allergen Labeling 

and Consumer Protection Act of 2004 (Public Law 108-282). 

"Meat" means the flesh of animals used as FOOD including the dressed 

flesh of cattle, swine, sheep, or goats and other edible animals, except 

FISH, POULTRY, and wild GAME ANIMALS as specified under Subparagraphs 

3-201.17(A)(3) and (4). 

"Mechanically Tenderized" means manipulating meat by piercing with a 

set of needles, pins, blades or any mechanical device, which breaks up 

muscle fiber and tough connective tissue, to increase tenderness. This 

includes INJECTION, scoring, and processes which may be referred to as 

“blade tenderizing,” “jaccarding,” “pinning,” or “needling”.

"mg/L" means milligrams per liter, which is the metric equivalent of parts 

per million (ppm). 

"Molluscan shellfish" means any edible species of fresh or frozen 

oysters, clams, mussels, and scallops or edible portions thereof, except 

when the scallop product consists only of the shucked adductor muscle. 

MOLLUSCAN SHELLFISH includes SHELLSTOCK, SHUCKED SHELLFISH and INSHELL PRODUCTS.

Non-Continuous Cooking.

(1) "Non-continuous cooking" means the cooking of FOOD in a 

FOOD ESTABLISHMENT using a process in which the initial heating of 

the FOOD is intentionally halted so that it may be cooled and held for 

complete cooking at a later time prior to sale or service.
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(2) "Non-continuous cooking" does not include cooking 

procedures that only involve temporarily interrupting or slowing an 

otherwise continuous cooking process.

Packaged.

(1) "Packaged" means bottled, canned, cartoned, bagged, or 

wrapped, whether PACKAGED in a FOOD ESTABLISHMENT or a FOOD 

PROCESSING PLANT. 

(2) "Packaged" does not include wrapped or placed in a carry-out 

container to protect the food during service or delivery to the 

consumer, by a food employee, upon consumer request.

"Permit" means the document issued by the REGULATORY AUTHORITY that 

authorizes a PERSON to operate a FOOD ESTABLISHMENT. 

"Permit holder" means the entity that: 

(1) Is legally responsible for the operation of the FOOD

ESTABLISHMENT such as the owner, the owner's agent, or other 

PERSON; and 

(2) Possesses a valid PERMIT to operate a FOOD ESTABLISHMENT.

"Person" means an association, a corporation, individual, partnership, 

other legal entity, government, or governmental subdivision or agency. 

"Person in charge" means the individual present at a FOOD

ESTABLISHMENT who is responsible for the operation at the time of 

inspection. 

Personal Care Items.

(1) "Personal care items" means items or substances that may be 

poisonous, toxic, or a source of contamination and are used to 

maintain or enhance a PERSON'S health, hygiene, or appearance.

(2) "Personal care items" include items such as medicines; first 

aid supplies; and other items such as cosmetics, and toiletries such 

as toothpaste and mouthwash.

"pH" means the symbol for the negative logarithm of the hydrogen ion 

concentration, which is a measure of the degree of acidity or alkalinity of a 

solution.

Values between 0 and 7 indicate acidity and values between 7 and 

14 indicate alkalinity. The value for pure distilled water is 7, which is 

considered neutral. 

"Physical facilities" means the structure and interior surfaces of a FOOD

ESTABLISHMENT including accessories such as soap and towel dispensers 

and attachments such as light fixtures and heating or air conditioning 

system vents. 

"Plumbing fixture" means a receptacle or device that:
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(1) Is permanently or temporarily connected to the water distribution 

system of the PREMISES and demands a supply of water from the 

system; or 

(2) Discharges used water, waste materials, or SEWAGE directly or 

indirectly to the drainage system of the PREMISES. 

"Plumbing system" means the water supply and distribution pipes; 

PLUMBING FIXTURES and traps; soil, waste, and vent pipes; sanitary and 

storm sewers and building drains, including their respective connections, 

devices, and appurtenances within the PREMISES; and water-treating 

EQUIPMENT. 

"Poisonous or toxic materials" means substances that are not intended 

for ingestion and are included in 5 categories: 

(1) Cleaners and SANITIZERS, which include cleaning and SANITIZING

agents and agents such as caustics, acids, drying agents, polishes, 

and other chemicals;

(2) Pesticides, except SANITIZERS, which include substances such as 

insecticides and rodenticides;

(3) Substances necessary for the operation and maintenance of the 

establishment such as nonfood grade lubricants and PERSONAL CARE 

ITEMS that may be deleterious to health; and 

(4) Substances that are not necessary for the operation and 

maintenance of the establishment and are on the PREMISES for retail 

sale, such as petroleum products and paints. 

(5) RESTRICTED USE PESTICIDE means a pesticide product that 

contains the active ingredients specified in 40 CFR 152.175 

Pesticides classified for restricted use, and that is limited to use by 

or under the direct supervision of a certified applicator.

"Poultry" means: 

(1) Any domesticated bird (chickens, turkeys, ducks, geese, 

guineas, ratites, or squabs), whether live or dead, as defined in 9 

CFR 381.1 Poultry Products Inspection Regulations Definitions, 

Poultry; and

(2) Any migratory waterfowl or game bird, pheasant, partridge, 

quail, grouse, or pigeon, whether live or dead, as defined in 9 CFR 

362.1 Voluntary Poultry Inspection Regulations, Definitions.

"Premises" means: 

(1) The PHYSICAL FACILITY, its contents, and the contiguous land or 

property under the control of the PERMIT HOLDER; or

(2) The PHYSICAL FACILITY, its contents, and the land or property not 

described in Subparagraph (1) of this definition if its facilities and 
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contents are under the control of the PERMIT HOLDER and may 

impact FOOD ESTABLISHMENT personnel, facilities, or operations, and 

a FOOD ESTABLISHMENT is only one component of a larger operation 

such as a health care facility, hotel, motel, school, recreational 

camp, or prison. 

"Primal cut" means a basic major cut into which carcasses and sides of 

MEAT are separated, such as a beef round, pork loin, lamb flank, or veal 

breast. 

Priority Item.

(1) "Priority item" means a provision in this Code whose 

application contributes directly to the elimination, prevention or 

reduction to an acceptable level, hazards associated with foodborne 

illness or injury and there is no other provision that more directly 

controls the hazard.

(2) "Priority item" includes items with a quantifiable measure to 

show control of hazards such as cooking, reheating, cooling, 

handwashing; and

(3) "Priority item" is an item that is denoted in this Code with a 

superscript “P” (i.e., P). 

Priority Foundation Item. 

(1) "Priority foundation item" means a provision in this Code 

whose application supports, facilitates or enables one or more 

PRIORITY ITEMS. 

(2) "Priority foundation item" includes an item that requires the 

purposeful incorporation of specific actions, equipment or 

procedures by industry management to attain control of risk 

factors that contribute to foodborne illness or injury such as 

personnel training, infrastructure or necessary equipment, 

HACCP plans, documentation or record keeping, and labeling; 

and 

(3) "Priority foundation item" is an item that is denoted in this 

Code with a superscript “Pf” (i.e., Pf). 

"Public water system" has the meaning stated in 40 CFR 141 National 

Primary Drinking Water Regulations. 

"Ratite" means a flightless bird such as an emu, ostrich, or rhea. 

Ready-to-Eat Food.

(1) "Ready-to-eat food" means FOOD that: 

(a) Is in a form that is edible without additional preparation to 

achieve FOOD safety, as specified under one of the following: 
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¶ 3-401.11(A) or (B), § 3-401.12, or § 3-402.11, or as 

specified in ¶ 3-401.11(C); or

(b) Is a raw or partially cooked animal FOOD and the 

consumer is advised as specified in Subparagraphs 3-

401.11(D)(1) and (3); or

(c) Is prepared in accordance with a variance that is granted 

as specified in Subparagraph 3-401.11(D) (4); and 

(d) May receive additional preparation for palatability or 

aesthetic, epicurean, gastronomic, or culinary purposes. 

(2) "Ready-to-eat food" includes: 

(a) Raw animal FOOD that is cooked as specified under § 3-

401.11 or 3-401.12, or frozen as specified under § 3-402.11; 

(b) Raw fruits and vegetables that are washed as specified 

under § 3-302.15;

(c) Plant FOODS that are cooked for hot holding, as specified 

under § 3-401.13; 

(d) All TIME/TEMPERATURE CONTROL FOR SAFETY FOOD that is 

cooked to the temperature and time required for the specific 

FOOD under Subpart 3-401 and cooled as specified under 

§ 3-501.14; 

(e) Plant FOOD for which further washing, cooking, or other 

processing is not required for FOOD safety, and from which 

rinds, peels, husks, or shells, if naturally present are 

removed;

(f) Substances derived from plants such as spices, 

seasonings, and sugar;

(g) A bakery item such as bread, cakes, pies, fillings, or icing 

for which further cooking is not required for FOOD safety;

(h) The following products that are produced in accordance 

with USDA guidelines and that have received a lethality 

treatment for pathogens: dry, fermented sausages, such as 

dry salami or pepperoni; salt-cured MEAT and POULTRY

products, such as prosciutto ham, country cured ham, and 

Parma ham; and dried MEAT and POULTRY products, such as 

jerky or beef sticks; and

(i) FOODS manufactured as specified in 21 CFR Part 113, 

Thermally Processed Low-Acid Foods Packaged in 

Hermetically Sealed Containers. 

(3) "Ready-to-eat food" does not include:
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(a) Commercially pACKAGED FOOD that bears a 

manufacturer’s cooking instructions; and

(b) FOOD for which the manufacturer has provided 

information that it has not been processed to control 

pathogens.

Reduced Oxygen Packaging. 

(1) "Reduced oxygen packaging" means:

(a) The reduction of the amount of oxygen in a PACKAGE by 

removing oxygen; displacing oxygen and replacing it with 

another gas or combination of gases; or otherwise 

controlling the oxygen content to a level below that normally 

found in the atmosphere (approximately 21% at sea level); 

and

(b) A process as specified in Subparagraph (1)(a) of this 

definition that involves a FOOD for which the HAZARDS

Clostridium botulinum or Listeria monocytogenes

require control in the final PACKAGED form. 

(2) "Reduced oxygen packaging" includes:

(a) Vacuum PACKAGING, in which air is removed from a 

PACKAGE of FOOD and the PACKAGE is HERMETICALLY SEALED

so that a vacuum remains inside the PACKAGE; 

(b) Modified atmosphere PACKAGING, in which the 

atmosphere of a PACKAGE of FOOD is modified so that its 

composition is different from air but the atmosphere may 

change over time due to the permeability of the PACKAGING 

material or the respiration of the FOOD. Modified atmosphere 

PACKAGING includes reduction in the proportion of oxygen, 

total replacement of oxygen, or an increase in the proportion 

of other gases such as carbon dioxide or nitrogen;

(c) Controlled atmosphere PACKAGING, in which the 

atmosphere of a PACKAGE of FOOD is modified so that until 

the PACKAGE is opened, its composition is different from air, 

and continuous control of that atmosphere is maintained, 

such as by using oxygen scavengers or a combination of 

total replacement of oxygen, nonrespiring FOOD, and 

impermeable PACKAGING material;

(d) Cook chill PACKAGING, in which cooked FOOD is hot filled 

into impermeable bags that are then sealed or crimped 

closed. The bagged FOOD is rapidly chilled and refrigerated 

at temperatures that inhibit the growth of psychrotrophic 

pathogens; or 
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(e) Sous vide PACKAGING, in which raw or partially cooked 

FOOD is vacuum packaged in an impermeable bag, cooked in 

the bag, rapidly chilled, and refrigerated at temperatures that 

inhibit the growth of psychrotrophic pathogens. 

"Refuse" means solid waste not carried by water through the SEWAGE

system.

"Regulatory authority" means the local, state, or federal enforcement 

body or authorized representative having jurisdiction over the FOOD

ESTABLISHMENT. 

"Reminder" means a written statement concerning the health RISK of 

consuming animal FOODS raw, undercooked, or without otherwise being 

processed to eliminate pathogens. 

"Re-service" means the transfer of FOOD that is unused and returned by a 

CONSUMER after being served or sold and in the possession of the 

CONSUMER, to another PERSON. 

"Restrict" means to limit the activities of a FOOD EMPLOYEE so that there is 

no RISK of transmitting a disease that is transmissible through FOOD and 

the FOOD EMPLOYEE does not work with exposed FOOD, clean EQUIPMENT,

UTENSILS, LINENS, or unwrapped SINGLE-SERVICE or SINGLE-USE ARTICLES. 

"Restricted egg" means any check, dirty EGG, incubator reject, inedible, 

leaker, or loss as defined in 9 CFR 590. 

"Restricted use pesticide" means a pesticide product that contains the 

active ingredients specified in 40 CFR 152.175 Pesticides classified for 

restricted use, and that is limited to use by or under the direct supervision 

of a certified applicator. 

"Risk" means the likelihood that an adverse health effect will occur within 

a population as a result of a HAZARD in a FOOD. 

"Safe material" means: 

(1) An article manufactured from or composed of materials that may 

not reasonably be expected to result, directly or indirectly, in their 

becoming a component or otherwise affecting the characteristics of 

any FOOD;

(2) An additive that is used as specified in § 409 of the Federal 

Food, Drug, and Cosmetic Act; or 

(3) Other materials that are not ADDITIVES and that are used in 

conformity with applicable regulations of the Food and Drug 

Administration.

"Sanitization" means the application of cumulative heat or chemicals on 

cleaned FOOD-CONTACT SURFACES that, when evaluated for efficacy, is 

sufficient to yield a reduction of 5 logs, which is equal to a 99.999% 
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reduction, of representative disease microorganisms of public health 

importance. 

"Sealed" means free of cracks or other openings that allow the entry or 

passage of moisture. 

"Service animal" means an animal such as a guide dog, signal dog, or 

other animal individually trained to provide assistance to an individual with 

a disability. 

"Servicing area" means an operating base location to which a mobile 

FOOD ESTABLISHMENT or transportation vehicle returns regularly for such 

things as vehicle and equipment cleaning, discharging liquid or solid 

wastes, refilling water tanks and ice bins, and boarding FOOD. 

"Sewage" means liquid waste containing animal or vegetable matter in 

suspension or solution and may include liquids containing chemicals in 

solution. 

"Shellfish control authority" means a state, federal, foreign, tribal, or 

other government entity legally responsible for administering a program 

that includes certification of MOLLUSCAN SHELLFISH harvesters and DEALERs 

for interstate commerce. 

"Shellstock" means live MOLLUSCAN SHELLFISH in the shell. 

"Shiga toxin-producing Escherichia coli" (STEC) means any E. coli

capable of producing Shiga toxins (also called verocytotoxins). STEC 

infections can be asymptomatic or may result in a spectrum of illness 

ranging from mild non-bloody diarrhea, to hemorrhagic colitis (i.e., bloody 

diarrhea), to hemolytic uremic syndrome (HUS - a type of kidney failure). 

Examples of serotypes of STEC include: E. coli O157:H7; E. coli

O157:NM; E. coli O26:H11; E. coli O145:NM; E. coli O103:H2; and E. coli

O111:NM. STEC are sometimes referred to as VTEC (verocytotoxigenic 

E. coli) or as EHEC (Enterohemorrhagic E. coli). EHEC are a subset of 

STEC which can cause hemorrhagic colitis or HUS.

"Shucked shellfish" means MOLLUSCAN SHELLFISH that have both shells 

removed. 

"Single-service articles" means TABLEWARE, carry-out UTENSILS, and 

other items such as bags, containers, placemats, stirrers, straws, 

toothpicks, and wrappers that are designed and constructed for one time, 

one PERSON use after which they are intended for discard. 

Single-Use Articles.

(1) "Single-use articles" means UTENSILS and bulk FOOD

containers designed and constructed to be used once and 

discarded.

(2) "Single-use articles" includes items such as wax paper, 

butcher paper, plastic wrap, formed aluminum FOOD containers, 
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jars, plastic tubs or buckets, bread wrappers, pickle barrels, ketchup 

bottles, and number 10 cans which do not meet the materials, 

durability, strength, and cleanability specifications under 

§§ 4-101.11, 4-201.11, and 4-202.11 for multiuse UTENSILS. 

"Slacking" means the process of moderating the temperature of a FOOD

such as allowing a FOOD to gradually increase from a temperature of -23oC 

(-10oF) to -4oC (25oF) in preparation for deep-fat frying or to facilitate even 

heat penetration during the cooking of previously block-frozen FOOD such 

as shrimp. 

"Smooth" means: 

(1) A FOOD-CONTACT SURFACE having a surface free of pits and 

inclusions with a cleanability equal to or exceeding that of (100 grit) 

number 3 stainless 

(2) A nonFOOD-CONTACT SURFACE of EQUIPMENT having a surface 

equal to that of commercial grade hot-rolled steel free of visible 

scale; and

(3) A floor, wall, or ceiling having an even or level surface with no 

roughness or projections that render it difficult to clean. 

"Tableware" means eating, drinking, and serving UTENSILS for table use 

such as flatware including forks, knives, and spoons; hollowware including 

bowls, cups, serving dishes, and tumblers; and plates. 

"Temperature measuring device" means a thermometer, thermocouple, 

thermistor, or other device that indicates the temperature of FOOD, air, or 

water. 

"Temporary food establishment" means a FOOD ESTABLISHMENT that 

operates for a period of no more than 14 consecutive days in conjunction 

with a single event or celebration. 

Time/Temperature Control for Safety Food (formerly “potentially 

hazardous food” (PHF)). 

(1) "Time/temperature control for safety food" means a FOOD

that requires time/temperature control for safety (TCS) to limit 

pathogenic microorganism growth or toxin formation.

(2) "Time/temperature control for safety food" includes: 

(a) An animal FOOD that is raw or heat-treated; a plant FOOD

that is heat-treated or consists of raw seed sprouts, cut 

melons, cut leafy greens, cut tomatoes or mixtures of cut 

tomatoes that are not modified in a way so that they are 

unable to support pathogenic microorganism growth or toxin 

formation, or garlic-in-oil mixtures that are not modified in a 

way so that they are unable to support pathogenic 

microorganism growth or toxin formation; and
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(b) Except as specified in Subparagraph (3)(d) of this 

definition, a food that because of the interaction of its aw 

and pH values is designat(b)ed as Product Assessment 

Required (PA) in Table A or B of this definition:

Table A. Interaction of pH and AW for control of spores in FOOD heat-treated

to destroy vegetative cells and subsequently PACKAGED

AW VALUES PH: 4.6 OR LESS PH: > 4.6 - 5.6 PH: > 5.6

≤0.92 Non-TCS food* non-TCS food non-TCS food

> 0.92 - 0.95 non-TCS food non-TCS food PA**

> 0.95 non-TCS food PA PA

* TCS FOOD means TIME/TEMPERATURE CONTROL FOR SAFETY FOOD

** PA means Product Assessment required

Table B. Interaction of PH and AW for control of vegetative cells and spores

in FOOD not heat-treated or heat-treated but not PACKAGED

AW VALUES PH: < 4.2 PH: 4.2 - 4.6 PH: > 4.6 - 5.0 PH: > 5.0

< 0.88 Non-TCS food* Non-TCS food non-TCS food non-TCS food

0.88 – 0.90 Non-TCS food Non-TCS food non-TCS food PA**

> 0.90 – 0.92 Non-TCS food Non-TCS food PA PA

> 0.92 Non-TCS food PA PA PA

* TCS FOOD means TIME/TEMPERATURE CONTROL FOR SAFETY FOOD

** PA means Product Assessment required

(3) "Time/temperature control for safety food" does not include:

(a) An air-cooled hard-boiled egg with shell intact, or an egg 

with shell intact that is not hard-boiled, but has been 

pasteurized to destroy all viable salmonellae;

(b) A FOOD in an unopened HERMETICALLY SEALED 

CONTAINTER that is commercially processed to achieve and

maintain commercial sterility under conditions of nonrefrigerated storage and distribution; 

(c) A FOOD that because of its PH or AW value, or interaction 

of AW and PH values, is designated as a non-TCS FOOD in 

Table A or B of this definition;
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(d) A FOOD that is designated as Product Assessment 

Required (PA) in Table A or B of this definition and has 

undergone a Product Assessment showing that the growth 

or toxin formation of pathogenic microorganisms that are 

reasonably likely to occur in that FOOD Is precluded due to:

(i) Intrinsic factors including added or natural 

characteristics of the FOOD such as preservatives, 

antimicrobials, humectants, acidulants, or nutrients,

(ii) Extrinsic factors including environmental or 

operational factors that affect the food such as 

packaging, modified atmosphere such as reduced 

oxygen packaging, shelf life and use, or temperature 

range of storage and use, or

(iii) A combination of intrinsic and extrinsic factors; or

(e) A FOOD that does not support the growth or toxin 

formation of pathogenic microorganisms in accordance 

with one of the Subparagraphs (3)(a) - (3)(d) of this 

definition even though the FOOD may contain a pathogenic 

microorganism or chemical or physical contaminant at a 

level sufficient to cause illness or injury.

"Tobacco Product" has the meaning stated in the Federal Food, Drug 

and Cosmetic Act §201(rr) (21 U.S.C. 321(rr)).

"USDA" means the U.S. Department of Agriculture.

"Utensil" means a FOOD-CONTACT implement or container used in the 

storage, preparation, transportation, dispensing, sale, or service of FOOD, 

such as KITCHENWARE or TABLEWARE that is multiuse, SINGLE-SERVICE, or 

SINGLE-USE; gloves used in contact with FOOD; temperature sensing probes 

of FOOD TEMPERATURE MEASURING DEVICES; and probe-type price or 

identification tags used in contact with FOOD.

"Variance" means a written document issued by the REGULATORY 

AUTHORITY that authorizes a modification or waiver of one or more 

requirements of this Code if, in the opinion of the REGULATORY AUTHORITY, 

a health HAZARD or nuisance will not result from the modification or waiver.

"Vending machine" means a self-service device that, upon insertion of a 

coin, paper currency, token, card, or key, or by electronic transaction or 

optional manual operation, dispenses unit servings of FOOD in bulk or in 

PACKAGES without the necessity of replenishing the device between each 

vending operation.

"Vending machine location" means the room, enclosure, space, or area 

where one or more VENDING MACHINES are installed and operated and 

includes the storage areas and areas on the PREMISES that are used to 

service and maintain the VENDING MACHINES.
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"Warewashing" means the cleaning and SANITIZING of UTENSILS and 

FOOD-CONTACT SURFACES of EQUIPMENT.

"Whole-muscle, intact beef" means whole muscle beef that is not 

injected, mechanically tenderized, reconstructed, or scored and 

marinated, from which beef steaks may be cut.
FDA Food Code 2022 Chapter 2. Management and Personnel

Chapter 2 - 1

Chapter 2 Management and 

Personnel

Parts:

2-1 Supervision

2-2 Employee Health

2-3 Personal Cleanliness

2-4 Hygienic Practices

2-5 Responding To Contamination Events

2-1 Supervision

2-101 Responsibility

2-101.11 Assignment 

(A) Except as specified in ¶¶ (B) and (C) of this section, the PERMIT HOLDER shall 

be the PERSON IN CHARGE or shall designate a PERSON IN CHARGE and shall ensure 

that a PERSON IN CHARGE is present at the FOOD ESTABLISHMENT during all hours of 

operation.Pf

(B) In a FOOD ESTABLISHMENT with two or more separately PERMITTED departments 

that are the legal responsibility of the same PERMIT HOLDER and that are located 

on the same PREMISES, the PERMIT HOLDER may, during specific time periods 

when food is not being prepared, packaged, or served, designate a single 

PERSON IN CHARGE who is present on the PREMISES during all hours of operation, 

and who is responsible for each separately PERMITTED FOOD ESTABLISHMENT on 

the PREMISES.

Pf

(C)This section does not apply to certain types of FOOD ESTABLISHMENTS deemed 

by the REGULATORY AUTHORITY to pose minimal risk of causing, or contributing to, 

foodborne illness based on the nature of the operation and extent of the FOOD

preparation.Pf

2-102 Knowledge

2-102.11 Demonstration.

Based on the RISKS inherent to the FOOD operation, during inspections and upon 

request the PERSON IN CHARGE shall demonstrate to the REGULATORY AUTHORITY

knowledge of foodborne disease prevention, application of the HAZARD Analysis 

and CRITICAL CONTROL POINT principles, and the requirements of this Code. The 

PERSON IN CHARGE shall demonstrate this knowledge by:
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(A) Complying with this Code by having no violations of PRIORITY ITEMS

during the current inspection; Pf

(B) Being a certified FOOD protection manager who has shown proficiency 

of required information through passing a test that is part of an ACCREDITED 

PROGRAM;

Pf or 

(C) Responding correctly to the inspector's questions as they relate to the 

specific FOOD operation. The areas of knowledge include: 

(1) Describing the relationship between the prevention of foodborne 

disease and the personal hygiene of a FOOD EMPLOYEE; Pf

(2) Explaining the responsibility of the PERSON IN CHARGE for 

preventing the transmission of foodborne disease by a FOOD 

EMPLOYEE who has a disease or medical condition that may cause 

foodborne disease; Pf

(3) Describing the symptoms associated with the diseases that are 

transmissible through FOOD; Pf

(4) Explaining the significance of the relationship between 

maintaining the time and temperature of TIME/TEMPERATURE

CONTROL FOR SAFETY FOOD and the prevention of foodborne illness; Pf

(5) Explaining the HAZARDS involved in the consumption of raw or 

undercooked MEAT, POULTRY, EGGS, and FISH; Pf

(6) Stating the required FOOD temperatures and times for safe 

cooking of TIME/TEMPERATURE CONTROL FOR SAFETY FOOD including 

MEAT, POULTRY, EGGS, and FISH; Pf

(7) Stating the required temperatures and times for the safe 

refrigerated storage, hot holding, cooling, and reheating of 

TIME/TEMPERATURE CONTROL FOR SAFETY FOOD; Pf

(8) Describing the relationship between the prevention of foodborne 

illness and the management and control of the following:

(a) Cross contamination, Pf

(b) Hand contact with READY-TO-EAT FOODS, Pf

(c) Handwashing, Pf and

(d) Maintaining the FOOD ESTABLISHMENT in a clean condition 

and in good repair; Pf

(9) Describing FOODS identified as MAJOR FOOD ALLERGENS and the 

symptoms that a MAJOR FOOD ALLERGEN could cause in a sensitive 

individual who has an allergic reaction. Pf

(10) Explaining the relationship between FOOD safety and providing 

EQUIPMENT that is: 

(a) Sufficient in number and capacity, Pf and
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(b) Properly designed, constructed, located, installed, 

operated, maintained, and cleaned; Pf

(11) Explaining correct procedures for cleaning and SANITIZING

UTENSILS and FOOD-CONTACT SURFACES of EQUIPMENT; Pf

(12) Identifying the source of water used and measures taken to 

ensure that it remains protected from contamination such as 

providing protection from backflow and precluding the creation of 

cross connections; Pf

(13) Identifying POISONOUS OR TOXIC MATERIALS in the FOOD

ESTABLISHMENT and the procedures necessary to ensure that they 

are safely stored, dispensed, used, and disposed of according to

LAW; Pf

(14) Identifying CRITICAL CONTROL POINTS in the operation from 

purchasing through sale or service that when not controlled may 

contribute to the transmission of foodborne illness and explaining 

steps taken to ensure that the points are controlled in accordance 

with the requirements of this Code; Pf

(15) Explaining the details of how the PERSON IN CHARGE and FOOD 

EMPLOYEES comply with the HACCP PLAN if a plan is required by the 

LAW, this Code, or an agreement between the REGULATORY 

AUTHORITY and the FOOD ESTABLISHMENT; Pf

(16) Explaining the responsibilities, rights, and authorities assigned 

by this Code to the: 

(a) Food employee, Pf

(b) Conditional employee, Pf

(c) Person in charge, Pf

(d) Regulatory authority; Pf and

(17) Explaining how the person in charge, food employees, and

conditional employees comply with reporting responsibilities and 

exclusion or restriction of food employees. Pf 

2-102.12 Certified Food Protection Manager

(A) The PERSON IN CHARGE shall be a certified FOOD protection manager who has 

shown proficiency of required information through passing a test that is part of an 

ACCREDITED PROGRAM.

(B) This section does not apply to certain types of FOOD ESTABLISHMENTS deemed 

by the REGULATORY AUTHORITY to pose minimal risk of causing, or contributing to, 

foodborne illness based on the nature of the operation and extent of FOOD

preparation.
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2-102.20 Food Protection Manager Certification.

(A) A PERSON IN CHARGE who demonstrates knowledge by being a FOOD

protection manager that is certified by a FOOD protection manager certification 

program that is evaluated and listed by a Conference for Food Protectionrecognized accrediting agency as conforming to the Conference for Food 

Protection Standard for Accreditation of FOOD Protection Manager Certification 

Programs is deemed to comply with ¶2-102.11(B). 

(B) A FOOD ESTABLISHMENT that has a PERSON IN CHARGE that is certified by a 

FOOD protection manager certification program that is evaluated and listed by a 

Conference for FOOD Protection-recognized accrediting agency as conforming to 

the Conference for FOOD Protection Standard for Accreditation of FOOD 

Protection Manager Certification Programs is deemed to comply with §2-102.12.

2-103 Duties

2-103.11 Person in Charge.

The PERSON IN CHARGE shall ensure that:

(A) FOOD ESTABLISHMENT operations are not conducted in a private home 

or in a room used as living or sleeping quarters as specified under § 6-

202.111; Pf

(B) PERSONS unnecessary to the FOOD ESTABLISHMENT operation are not 

allowed in the FOOD preparation, FOOD storage, or WAREWASHING areas, 

except that brief visits and tours may be authorized by the PERSON IN 

CHARGE if steps are taken to ensure that exposed FOOD; clean EQUIPMENT, 

UTENSILS, and LINENS; and unwrapped SINGLE-SERVICE and SINGLE-USE

ARTICLES are protected from contamination; Pf

(C) EMPLOYEES and other PERSONS such as delivery and maintenance 

PERSONS and pesticide applicators entering the FOOD preparation, FOOD

storage, and WAREWASHING areas comply with this Code; Pf

(D) EMPLOYEES are effectively cleaning their hands, by routinely monitoring 

the EMPLOYEES' handwashing; Pf

(E) EMPLOYEES are visibly observing FOODS as they are received to 

determine that they are from APPROVED sources, delivered at the required 

temperatures, protected from contamination, UNADULTERED, and accurately 

presented, by routinely monitoring the EMPLOYEES’ observations and 

periodically evaluating FOODS upon their receipt; Pf

(F) EMPLOYEES are verifying that FOODS delivered to the FOOD

ESTABLISHMENT during non-operating hours are from APPROVED sources 

and are placed into appropriate storage locations such that they are 

maintained at the required temperatures, protected from contamination, 

unADULTERATED, and accurately presented;Pf

(G) EMPLOYEES are properly cooking TIME/TEMPERATURE CONTROL FOR 

SAFETY FOOD, being particularly careful in cooking those FOODS known to 
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cause severe foodborne illness and death, such as EGGS and COMMINUTED

MEATS, through daily oversight of the EMPLOYEES' routine monitoring of the 

cooking temperatures using appropriate temperature measuring devices 

properly scaled and calibrated as specified under § 4-203.11 and 

¶ 4-502.11(B); Pf

(H) EMPLOYEES are using proper methods to rapidly cool

TIME/TEMPERATURE CONTROL FOR SAFETY FOODS that are not held hot or are 

not for consumption within 4 hours, through daily oversight of the 

EMPLOYEES' routine monitoring of FOOD temperatures during cooling; Pf

(I) EMPLOYEES are properly maintaining the temperatures of 

TIME/TEMPERATURE CONTROL FOR SAFETY FOODS during hot and cold holding

through daily oversight of the EMPLOYEES’ routine monitoring of FOOD

temperatures; Pf

(J) FOOD EMPLOYEES are properly maintaining the temperature of 

TIME/TEMPERATURE CONTROL FOR SAFETY FOODS during thawing through 

daily oversight of the FOOD EMPLOYEE’S routine monitoring of FOOD

temperatures; Pf

(K) CONSUMERS who order raw or partially cooked READY-TO-EAT FOODS of 

animal origin are informed as specified under § 3-603.11 that the FOOD is 

not cooked sufficiently to ensure its safety; Pf

(L) EMPLOYEES are properly SANITIZING cleaned multiuse EQUIPMENT and 

UTENSILS before they are reused, through routine monitoring of solution 

temperature and exposure time for hot water SANITIZING, and chemical 

concentration, pH, temperature, and exposure time for chemical 

SANITIZING; Pf

(M) CONSUMERS are notified that clean TABLEWARE is to be used when they 

return to self-service areas such as salad bars and buffets as specified 

under § 3-304.16; Pf

(N) Except when APPROVAL is obtained from the REGULATORY AUTHORITY as 

specified in ¶ 3-301.11(E), EMPLOYEES are preventing cross-contamination 

of READY-TO-EAT FOOD with bare hands by properly using suitable UTENSILS

such as deli tissue, spatulas, tongs, single-use gloves, or dispensing 

EQUIPMENT; Pf

(O) EMPLOYEES are properly trained in FOOD safety, including FOOD allergy 

awareness, as it relates to their assigned duties. FOOD allergy awareness 

includes describing FOODS identified as MAJOR FOOD ALLERGENS and the 

symptoms that a MAJOR FOOD ALLERGEN could cause in a sensitive 

individual who has an allergic reaction; Pf

(P) FOOD EMPLOYEES and CONDITIONAL EMPLOYEES are informed in a 

verifiable manner of their responsibility to report in accordance with LAW, 

to the PERSON IN CHARGE, information about their health and activities as 

they relate to diseases that are transmissible through FOOD, as specified 

under ¶ 2-201.11(A); Pf and
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(Q) Written procedures and plans, where specified by this Code and as 

developed by the FOOD ESTABLISHMENT, are maintained and implemented 

as required. Pf

2-2 Employee Health

2-201 Responsibilities of Permit Holder, Person in Charge, Food 

Employees, and Conditional Employees

2-201.11 Responsibility of Permit Holder, Person in Charge, and 

Conditional Employees.

(A) The PERMIT HOLDER shall require FOOD EMPLOYEES and CONDITIONAL 

EMPLOYEES to report to the PERSON IN CHARGE information about their health and 

activities as they relate to diseases that are transmissible through FOOD. A FOOD 

EMPLOYEE or CONDITIONAL EMPLOYEE shall report the information in a manner that 

allows the PERSON IN CHARGE to reduce the RISK of foodborne disease 

transmission, including providing necessary additional information, such as the 

date of onset of symptoms and an illness, or of a diagnosis without symptoms, if 

the FOOD EMPLOYEE or CONDITIONAL EMPLOYEE:

Reportable symptoms

(1) Has any of the following symptoms:

(a) Vomiting,P

(b) Diarrhea,P

(c) Jaundice,P

(d) Sore throat with fever,P or 

(e) A lesion containing pus such as a boil or infected wound that is 

open or draining and is:

(i) On the hands or wrists, unless an impermeable cover 

such as a finger cot or stall protects the lesion and a SINGLEUSE glove is worn over the impermeable cover,P

(ii) On exposed portions of the arms, unless the lesion is 

protected by an impermeable cover,P or

(iii) On other parts of the body, unless the lesion is covered 

by a dry, durable, tight-fitting bandage;P

Reportable diagnosis

(2) Has an illness diagnosed by a HEALTH PRACTITIONER due to: 

(a) Norovirus,P

(b) Hepatitis A virus,P
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(c) Shigella spp., P

(d) Shiga toxin-producing Escherichia coli,P

(e) Typhoid fever (caused by Salmonella Typhi)P or

(f) Salmonella (nontyphoidal);P

Reportable past illness

(3) Had Typhoid fever, diagnosed by a health practitioner, within the past 

three (3) months, without having received antibiotic therapy, as 

determined by a health practitioner;P

Reportable history of exposure

(4) Has been exposed to, or is the suspected source of, a confirmed 

disease outbreak, because the food employee or conditional employee 

consumed or prepared food implicated in the outbreak, or consumed food 

at an event prepared by a person who is infected or ill with:

(a) Norovirus within the past 48 hours of the last exposure,P

(b) SHIGA TOXIN-PRODUCING ESCHERICHIA COLI or Shigella spp. within 

the past 3 days of the last exposure,P

(c) Typhoid fever within the past 14 days of the last exposure,P or

(d) Hepatitis A virus within the past 30 days of the last exposure;P or

Reportable history of exposure

(5) Has been exposed by attending or working in a setting where there is a 

CONFIRMED DISEASE OUTBREAK, or living in the same household as, and has 

knowledge about, an individual who works or attends a setting where 

there is a CONFIRMED DISEASE OUTBREAK, or living in the same household 

as, and has knowledge about, an individual diagnosed with an illness 

caused by: 

(a) Norovirus within the past 48 hours of the last exposure,P

(b) SHIGA TOXIN-PRODUCING ESCHERICHIA COLI or Shigella spp. within 

the past 3 days of the last exposure,P

(c) Typhoid fever (caused by Salmonella Typhi) within the past 14 

days of the last exposure,P or

(d) Hepatitis A virus within the past 30 days of the last exposure.P

Responsibility of person in charge to notify the regulatory authority

(B) The person in charge shall notify the regulatory authority when a food 

employee is: 
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(1) Jaundiced,Pf or

(2) Diagnosed with an illness due to a pathogen as specified under 

Subparagraphs (A)(2)(a) - (f) of this section.Pf

Responsibility of the person in charge to prohibit a conditional employee from becoming 

a food employee

(C) The person in charge shall ensure that a conditional employee:

(1) Who exhibits or reports a symptom, or who reports a diagnosed illness 

as specified under Subparagraphs (A)(1) - (3) of this section, is prohibited 

from becoming a FOOD EMPLOYEE until the CONDITIONAL EMPLOYEE meets 

the criteria for the specific symptoms or diagnosed illness as specified 

under § 2-201.13;P and

(2) Who will work as a FOOD EMPLOYEE in a FOOD ESTABLISHMENT that 

serves as a HIGHLY SUSCEPTIBLE POPULATION and reports a history of 

exposure as specified under Subparagraphs (A)(4) – (5), is prohibited

from becoming a FOOD EMPLOYEE until the CONDITIONAL EMPLOYEE meets 

the criteria as specified under ¶ 2-201.13(J). P 

Responsibility of the person in charge to exclude or restrict

(D) The PERSON IN CHARGE shall ensure that a FOOD EMPLOYEE who exhibits or 

reports a symptom, or who reports a diagnosed illness or a history of exposure 

as specified under Subparagraphs (A)(1) - (5) of this section is:

(1) EXCLUDED as specified under ¶¶ 2-201.12 (A) - (C), and 

Subparagraphs (D)(1), (E)(1), (F)(1), or (H)(1) and in compliance with the 

provisions specified under ¶¶ 2-201.13(A) - (H); P or

(2) RESTRICTED as specified under Subparagraphs 2-201.12 (D)(2), (E)(2), 

(F)(2), (G), (H)(2), or ¶¶ 2-201.12(I) or (J) and in compliance with the 

provisions specified under ¶¶ 2-201.13(D) - (J). P 

Responsibility of food employees and conditional employees to report

(E) A FOOD EMPLOYEE or CONDITIONAL EMPLOYEE shall report to the PERSON IN 

CHARGE the information as specified under ¶ (A) of this section.Pf

 

Responsibility of food employees to comply

(F) A FOOD EMPLOYEE shall: 

(1) Comply with an EXCLUSION as specified under ¶¶ 2-201.12(A) - (C) and 

Subparagraphs 2-201.12(D)(1), (E)(1), (F)(1), (G), or (H)(1) and with the 

provisions specified under ¶¶ 2-201.13(A) - (H); P or

(2) Comply with a RESTRICTION as specified under 

Subparagraphs 2-201.12(D)(2), (E)(2), (F)(2), (G), (H)(2), or ¶¶ 2-201.12 
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(H), (I), or (J) and comply with the provisions specified under 

¶¶ 2-201.13(D) - (J). P

Conditions of exclusion and restriction

2-201.12 Exclusions and Restrictions.

The PERSON IN CHARGE shall EXCLUDE or RESTRICT a FOOD EMPLOYEE from a FOOD 

ESTABLISHMENT in accordance with the following: 

Symptomatic with vomiting or diarrhea

(A) Except when the symptom is from a noninfectious condition, EXCLUDE

a FOOD EMPLOYEE if the FOOD EMPLOYEE is: 

(1) Symptomatic with vomiting or diarrhea;P or

(2) Symptomatic with vomiting or diarrhea and diagnosed with an 

infection from Norovirus, Shigella spp., Salmonella (nontyphoidal),

or SHIGA TOXIN-PRODUCING E. COLI.

P

Jaundiced or diagnosed with Hepatitis A infection

(B) Exclude a food employee who is:

(1) Jaundiced and the onset of jaundice occurred within the last 7 

calendar days, unless the FOOD EMPLOYEE provides to the PERSON IN 

CHARGE written medical documentation from a HEALTH PRACTITIONER 

specifying that the jaundice is not caused by hepatitis A virus or 

other fecal-orally transmitted infection;P

(2) Diagnosed with an infection from Hepatitis A virus within 14 

calendar days from the onset of any illness symptoms, or within 7 

calendar days of the onset of jaundice;P or

(3) Diagnosed with an infection from hepatitis A virus without 

developing symptoms.P

Diagnosed or reported previous illness with Typhoid Fever

(C) EXCLUDE a food EMPLOYEE who is diagnosed with Typhoid fever, or 

reports having had Typhoid fever within the past 3 months as specified 

under Subparagraph 2-201.11(A)(3). P

Diagnosed with an asymptomatic infection from Norovirus

(D) If a FOOD EMPLOYEE is diagnosed with an infection from Norovirus and

is ASYMPTOMATIC:

(1) Exclude the food employee who works in a food establishment

serving a highly susceptible population;

Por
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(2) Restrict the food employee who works in a food establishment

not serving a highly susceptible population.

P

Diagnosed with Shigella spp. Infection and asymptomatic

(E) If a FOOD EMPLOYEE is diagnosed with an infection from Shigella spp. 

and is ASYMPTOMATIC: 

(1) Exclude the food employee who works in a food establishment

serving a highly susceptible population;

P or

(2) Restrict the food employee who works in a food establishment

not serving a highly susceptible population.

P

Diagnosed with STEC and asymptomatic

(F) If a FOOD EMPLOYEE is diagnosed with an infection from SHIGA TOXINPRODUCING E. COLI, and is ASYMPTOMATIC: 

(1) Exclude the food employee who works in a food establishment

serving a highly susceptible population;

Por

(2) Restrict the food employee who works in a food establishment

not serving a highly susceptible population.

P 

Diagnosed with nontyphoidal Salmonella and asymptomatic

(G) If a FOOD EMPLOYEE is diagnosed with an infection from Salmonella

(nontyphoidal) and is ASYMPTOMATIC, RESTRICT the FOOD EMPLOYEE who 

works in a FOOD ESTABLISHMENT serving a HIGHLY SUSCEPTIBLE POPULATION 

or in a FOOD ESTABLISHMENT not serving a HIGHLY SUSCEPTIBLE 

POPULATION.

P

Symptomatic with sore throat with fever

(H) If a FOOD EMPLOYEE is ill with symptoms of acute onset of sore throat 

with fever: 

(1) Exclude the food employee who works in a food establishment

serving a highly susceptible population;

Por

(2) Restrict the food employee who works in a food establishment

not serving a highly susceptible population.

P

Symptomatic with uncovered infected wound or pustular boil

(I) If a FOOD EMPLOYEE is infected with a skin lesion containing pus such as 

a boil or infected wound that is open or draining and not properly covered 

as specified under Subparagraph 2-201.11(A)(1)(e), RESTRICT the FOOD 

EMPLOYEE.

P
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Exposed to foodborne pathogen and works in food establishment serving HSP

(J) If a FOOD EMPLOYEE is exposed to a foodborne pathogen as specified 

under Subparagraphs 2-201.11(A)(4)(a-d) or 2-201.11(A)(5)(a-d), 

RESTRICT the FOOD EMPLOYEE who works in a FOOD ESTABLISHMENT serving 

a HIGHLY SUSCEPTIBLE POPULATION.

P

Managing Exclusions and Restrictions

2-201.13 Removal, Adjustment, or Retention of Exclusions and 

Restrictions.

The PERSON IN CHARGE shall adhere to the following conditions when removing, 

adjusting, or retaining the EXCLUSION or RESTRICTION of a FOOD EMPLOYEE:

(A) Except when a FOOD EMPLOYEE is diagnosed with Typhoid fever or an 

infection from hepatitis A virus:

Removing exclusion for food employee who was symptomatic and not diagnosed

(1) Reinstate a FOOD EMPLOYEE who was EXCLUDED as specified 

under Subparagraph 2-201.12(A)(1) if the FOOD EMPLOYEE: 

(a) Is ASYMPTOMATIC for at least 24 hours;P or

(b) Provides to the PERSON IN CHARGE written medical 

documentation from a HEALTH PRACTITIONER that states the 

symptom is from a noninfectious condition.P 

Norovirus diagnosis

(2) If a FOOD EMPLOYEE was diagnosed with an infection from 

Norovirus and EXCLUDED as specified under Subparagraph 

2-201.12(A)(2): 

Adjusting exclusion for food employee who was symptomatic and is now asymptomatic

(a) RESTRICT the FOOD EMPLOYEE, who is ASYMPTOMATIC for 

at least 24 hours and works in a FOOD ESTABLISHMENT not 

serving a HIGHLY SUSCEPTIBLE POPULATION, until the 

conditions for reinstatement as specified under 

Subparagraphs (D)(1) or (2) of this section are met;P or

Retaining exclusion for food employee who was asymptomatic and is now 

asymptomatic and works in food establishment serving HSP

(b) Retain the EXCLUSION for the FOOD EMPLOYEE, who is 

ASYMPTOMATIC for at least 24 hours and works in a FOOD 

ESTABLISHMENT that serves a HIGHLY SUSCEPTIBLE 

POPULATION, until the conditions for reinstatement as 
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specified under Subparagraphs (D)(1) or (2) of this section 

are met.

P

Shigella spp. diagnosis

(3) If a FOOD EMPLOYEE was diagnosed with an infection from 

Shigella spp. and EXCLUDED as specified under Subparagraph 

2-201.12(A)(2): 

Adjusting exclusion for food employee who was symptomatic and is now asymptomatic

(a) RESTRICT the FOOD EMPLOYEE, who is ASYMPTOMATIC for 

at least 24 hours and works in a FOOD ESTABLISHMENT not 

serving a HIGHLY SUSCEPTIBLE POPULATION, until the 

conditions for reinstatement as specified under 

Subparagraphs (E)(1) or (2) of this section are met;P or

Retaining exclusion for food employee who was asymptomatic and is now 

asymptomatic

(b) Retain the EXCLUSION for the FOOD EMPLOYEE, who is 

ASYMPTOMATIC for at least 24 hours and works in a FOOD 

ESTABLISHMENT that serves a HIGHLY SUSCEPTIBLE 

POPULATION, until the conditions for reinstatement as 

specified under Subparagraphs (E)(1) or (2) , or (E)(1) and 

(3)(a) of this section are met.P 

STEC diagnosis

(4) If a FOOD EMPLOYEE was diagnosed with an infection from SHIGA 

TOXIN-PRODUCING ESCHERICHIA COLI and EXCLUDED as specified 

under Subparagraph 2-201.12(A)(2): 

Adjusting exclusion for food employee who was symptomatic and is now asymptomatic

(a) RESTRICT the FOOD EMPLOYEE, who is ASYMPTOMATIC for 

at least 24 hours and works in a FOOD ESTABLISHMENT not 

serving a HIGHLY SUSCEPTIBLE POPULATION, until the 

conditions for reinstatement as specified under 

Subparagraphs (F)(1) or (2) of this section are met;P or

Retaining exclusion for food employee who was symptomatic and is now asymptomatic 

and works in food establishment serving HSP

(b) Retain the EXCLUSION for the FOOD EMPLOYEE, who is 

ASYMPTOMATIC for at least 24 hours and works in a FOOD 

ESTABLISHMENT that serves a HIGHLY SUSCEPTIBLE 

POPULATION, until the conditions for reinstatement as 
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specified under Subparagraphs (F)(1) or (2) are met.P

Nontyphoidal Salmonella Diagnosis

(5) If a FOOD EMPLOYEE was diagnosed with an infection from 

Salmonella (nontyphoidal) and EXCLUDED as specified under 

Subparagraph 2-201.12(A)(2):

Adjusting exclusion for food employee who was symptomatic and is now asymptomatic

(a) RESTRICT the FOOD EMPLOYEE, who is ASYMPTOMATIC for at 

least 30 days until conditions for reinstatement as specified 

under Subparagraphs (G)(1) or (2) of this section are met;P

or

Retaining exclusion for food employee that remains symptomatic

(b) Retain the EXCLUSION for the FOOD EMPLOYEE who is 

SYMPTOMATIC, until conditions for reinstatement as specified 

under Paragraphs (G)(1) or (G)(2) of this section are met.P

Hepatitis A virus or jaundice diagnosis - removing exclusions

(B) Reinstate a FOOD EMPLOYEE who was EXCLUDED as specified under 

¶ 2-201.12(B) if the PERSON IN CHARGE obtains APPROVAL from the 

REGULATORY AUTHORITY and one of the following conditions is met;

(1) The FOOD EMPLOYEE has been jaundiced for more than 

7 calendar days;P

(2) The anicteric FOOD EMPLOYEE has been symptomatic with 

symptoms other than jaundice for more than 14 calendar days;P or

(3) The FOOD EMPLOYEE provides to the PERSON IN CHARGE written 

medical documentation from a HEALTH PRACTITIONER stating that the 

FOOD EMPLOYEE is free of a hepatitis A virus infection.P 

Typhoid fever diagnosis - removing exclusions

(C) Reinstate a FOOD EMPLOYEE who was EXCLUDED as specified under 

¶ 2-201.12(C) if: 

(1) The person in charge obtains approval from the regulatory 

authority;

P and

(2) The food employee provides to the person in charge written 

medical documentation from a health practitioner that states the 

food employee is free from Typhoid fever.P 
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Chapter 2 - 14

Norovirus Diagnosis - Removing Exclusion Or Restriction

(D) Reinstate a FOOD EMPLOYEE who was EXCLUDED as specified under 

Subparagraphs 2-201.12(A)(2) or (D)(1) who was RESTRICTED under 

Subparagraph 2-201.12(D)(2) if the PERSON IN CHARGE obtains APPROVAL

from the REGULATORY AUTHORITY and one of the following conditions is 

met: 

(1) The EXCLUDED or RESTRICTED FOOD EMPLOYEE provides to the 

PERSON IN CHARGE written medical documentation from a HEALTH 

PRACTITIONER stating that the FOOD EMPLOYEE is free of a Norovirus 

infection;P

(2) The FOOD EMPLOYEE was EXCLUDED or RESTRICTED after 

symptoms of vomiting or diarrhea resolved, and more than 48 hours 

have passed since the FOOD EMPLOYEE became ASYMPTOMATIC;

P or 

(3) The FOOD EMPLOYEE was EXCLUDED or RESTRICTED and did not 

develop symptoms and more than 48 hours have passed since the 

FOOD EMPLOYEE was diagnosed.P 

Shigella spp. Diagnosis - Removing Exclusion Or Restriction

(E) Reinstate a FOOD EMPLOYEE who was EXCLUDED as specified under 

Subparagraphs 2-201.12(A)(2) or (E)(1) or who was RESTRICTED under 

Subparagraph 2-201.12(E)(2) if the PERSON IN CHARGE obtains APPROVAL

from the REGULATORY AUTHORITY and one of the following conditions is 

met: 

(1) The EXCLUDED or RESTRICTED FOOD EMPLOYEE provides to the 

PERSON IN CHARGE written medical documentation from a HEALTH 

PRACTITIONER stating that the FOOD EMPLOYEE is free of a Shigella

spp. infection based on test results showing 2 consecutive negative 

stool specimen cultures that are taken: 

(a) Not earlier than 48 hours after discontinuance of 

antibiotics,P and

(b) At least 24 hours apart;P

(2) The FOOD EMPLOYEE was EXCLUDED or RESTRICTED after 

symptoms of vomiting or diarrhea resolved, and more than 7 

calendar days have passed since the FOOD EMPLOYEE became 

ASYMPTOMATIC;

P or

(3) The FOOD EMPLOYEE was EXCLUDED or RESTRICTED and did not 

develop symptoms and more than 7 calendar days have passed 

since the FOOD EMPLOYEE was diagnosed.P
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STEC diagnosis - removing exclusion or restriction

(F) Reinstate a FOOD EMPLOYEE who was EXCLUDED or RESTRICTED as 

specified under Subparagraphs 2-201.12(A)(2) or (F)(1) or who was 

RESTRICTED under Subparagraph 2-201.12(F)(2) if the PERSON IN CHARGE

obtains APPROVAL from the REGULATORY AUTHORITY and one of the 

following conditions is met: 

(1) The EXCLUDED or RESTRICTED FOOD EMPLOYEE provides to the 

PERSON IN CHARGE written medical documentation from a HEALTH 

PRACTITIONER stating that the FOOD EMPLOYEE is free of an infection 

from SHIGA TOXIN-PRODUCING ESCHERICHIA COLI based on test results 

that show 2 consecutive negative stool specimen cultures that are 

taken: 

(a) Not earlier than 48 hours after discontinuance of 

antibiotics;P and

(b) At least 24 hours apart;P

(2) The FOOD EMPLOYEE was EXCLUDED or RESTRICTED after 

symptoms of vomiting or diarrhea resolved and more than 7 

calendar days have passed since the FOOD EMPLOYEE became 

ASYMPTOMATIC;

P or 

(3) The FOOD EMPLOYEE was EXCLUDED or RESTRICTED and did not 

develop symptoms and more than 7 days have passed since the 

FOOD EMPLOYEE was diagnosed.P

Nontyphoidal Salmonella - removing exclusion or restriction

(G) Reinstate a food employee who was EXCLUDED as specified under 

Subpargraph 2-201.12(A)(2) or who was RESTRICTED as specified under 

¶ 2-201.12(G) if the PERSON IN CHARGE obtains APPROVAL from the 

REGULATORY AUTHORITY P and one of the following conditions is met:

(1) The EXCLUDED or RESTRICTED FOOD EMPLOYEE provides to the 

PERSON IN CHARGE written medical documentation from a HEALTH 

PRACTITIONER stating that the FOOD EMPLOYEE is free of a Salmonella

(nontyphoidal) infection based on test results showing 2 

consecutive negative stool specimen cultures that are taken;

(a) Not earlier than 48 hours after discontinuance of 

antibiotics,P and

(b) At least 24 hours apart;P

(2) The FOOD EMPLOYEE was RESTRICTED after symptoms of vomiting 

or diarrhea resolved, and more than 30 days have passed since the 

FOOD EMPLOYEE became ASYMPTOMATIC;

P or
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Chapter 2 - 16

(3) The FOOD EMPLOYEE was EXCLUDED or RESTRICTED and did not 

develop symptoms and more than 30 days have passed since the 

FOOD EMPLOYEE was diagnosed.P

Sore throat with fever - removing exclusion or restriction

(H) Reinstate a FOOD EMPLOYEE who was EXCLUDED or RESTRICTED as 

specified under Subparagraphs 2-201.12(H)(1) or (2) if the FOOD EMPLOYEE

provides to the PERSON IN CHARGE written medical documentation from a 

HEALTH PRACTITIONER stating that the FOOD EMPLOYEE meets one of the 

following conditions: 

(1) Has received antibiotic therapy for Streptococcus pyogenes 

infection for more than 24 hours;P

(2) Has at least one negative throat specimen culture for 

Streptococcus pyogenes infection;P or 

(3) Is otherwise determined by a HEALTH PRACTITIONER to be free of 

a Streptococcus pyogenes infection.P

Uncovered infected wound or pustular boil - removing restriction

(I) Reinstate a FOOD EMPLOYEE who was RESTRICTED as specified under 

¶ 2-201.12(I) if the skin, infected wound, cut, or pustular boil is properly 

covered with one of the following: 

(1) An impermeable cover such as a finger cot or stall and a singleuse glove over the impermeable cover if the infected wound or 

pustular boil is on the hand, finger, or wrist;

P

(2) An impermeable cover on the arm if the infected wound or 

pustular boil is on the arm;

Por

(3) A dry, durable, tight-fitting bandage if the infected wound or 

pustular boil is on another part of the body.

P

Exposure to foodborne pathogen and works in food establishment serving HSP –

removing restriction

(J) Reinstate a FOOD EMPLOYEE who was RESTRICTED as specified under 

¶ 2-201.12(J) and was exposed to one of the following pathogens as 

specified under Subparagraph 2-201.11(A)(4)(a-d) or 2-201.11(A)(5)(a-d): 

Norovirus

(1) Norovirus and one of the following conditions is met: 

(a) More than 48 hours have passed since the last day the 

FOOD EMPLOYEE was potentially exposed;

P or 

(b) More than 48 hours have passed since the FOOD
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EMPLOYEE’S household contact became ASYMPTOMATIC.

P

Shigella spp. or STEC

(2) Shigella spp. or SHIGA TOXIN-PRODUCING ESCHERICHIA COLI and 

one of the following conditions is met: 

(a) More than 3 calendar days have passed since the last 

day the FOOD EMPLOYEE was potentially exposed;

P or 

(b) More than 3 calendar days have passed since the FOOD 

EMPLOYEE’S household contact became ASYMPTOMATIC.

P 

Typhoid fever (S. Typhi)

(3) Typhoid fever (caused by Salmonella Typhi) and one of the 

following conditions is met: 

(a) More than 14 calendar days have passed since the last 

day the FOOD EMPLOYEE was potentially exposed;

P or 

(b) More than 14 calendar days have passed since the FOOD 

EMPLOYEE’S household contact became ASYMPTOMATIC.

P

Hepatitis A

(4) Hepatitis A virus and one of the following conditions is met: 

(a) The FOOD EMPLOYEE is immune to hepatitis A virus

infection because of a prior illness from hepatitis A;

P

(b) The FOOD EMPLOYEE is immune to hepatitis A virus 

infection because of vaccination against hepatitis A;

P

(c) The FOOD EMPLOYEE is immune to hepatitis A virus 

infection because of IgG administration;

P

(d) More than 30 calendar days have passed since the last 

day the FOOD EMPLOYEE was potentially exposed;

P

(e) More than 30 calendar days have passed since the FOOD 

EMPLOYEE’S household contact became jaundiced;

P or

(f) The FOOD EMPLOYEE does not use an alternative 

procedure that allows bare hand contact with READY-TO-EAT 

FOOD until at least 30 days after the potential exposure, as 

specified in Subparagraphs (I)(4)(d) and (e) of this section, 

and the FOOD EMPLOYEE receives additional training about: 

(i) Hepatitis A symptoms and preventing the 

transmission of infection,P

(ii) Proper handwashing procedures,P and
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Chapter 2 - 18

(iii) Protecting READY-TO-EAT FOOD from contamination 

introduced by bare hand contact.P

2-3 Personal Cleanliness

2-301 Hands and Arms

2-301.11 Clean Condition.

FOOD EMPLOYEES shall keep their hands and exposed portions of their arms 

clean.P

2-301.12 Cleaning Procedure.

(A) Except as specified in ¶ (D) of this section, FOOD EMPLOYEES shall clean their 

hands and exposed portions of their arms, including surrogate prosthetic devices 

for hands or arms for at least 20 seconds, using a cleaning compound in a 

HANDWASHING SINK that is equipped as specified under § 5-202.12 and Subpart 

6-301. P

(B) FOOD EMPLOYEES shall use the following cleaning procedure in the order 

stated to clean their hands and exposed portions of their arms, including 

surrogate prosthetic devices for hands and arms: 

(1) Rinse under clean, running warm water; P

(2) Apply an amount of cleaning compound recommended by the cleaning 

compound manufacturer; P

(3) Rub together vigorously for at least 10 to 15 seconds while:

(a) Paying particular attention to removing soil from underneath the 

fingernails during the cleaning procedure, P and

(b) Creating friction on the surfaces of the hands and arms or 

surrogate prosthetic devices for hands and arms, finger tips, and 

areas between the fingers; P

(4) Thoroughly rinse under clean, running warm water; P and

(5) Immediately follow the cleaning procedure with thorough drying using a 

method as specified under § 6-301.12. P

(C) TO avoid recontaminating their hands or surrogate prosthetic devices, FOOD 

EMPLOYEES may use disposable paper towels or similar clean barriers when 

touching surfaces such as manually operated faucet handles on a HANDWASHING 

SINK or the handle of a restroom door.

(D) If APPROVED and capable of removing the types of soils encountered in the 

FOOD operations involved, an automatic handwashing facility may be used by 

FOOD EMPLOYEES to clean their hands or surrogate prosthetic devices. 

2-301.13 Special Handwash Procedures.

Reserved. 
FDA Food Code 2022 Chapter 2. Management and Personnel

Chapter 2 - 19

2-301.14 When to Wash.

FOOD EMPLOYEES shall clean their hands and exposed portions of their arms as 

specified under § 2-301.12 immediately before engaging in FOOD preparation 

including working with exposed FOOD, clean EQUIPMENT and UTENSILS, and 

unwrapped SINGLE-SERVICE and SINGLE-USE ARTICLESP and: 

(A) After touching bare human body parts other than clean hands and 

clean, exposed portions of arms; P

(B) After using the toilet room; P

(C) After caring for or handling SERVICE ANIMALS or aquatic animals as 

specified in ¶ 2-403.11(B); P

(D) Except as specified in ¶ 2-401.11(B), after coughing, sneezing, using a 

handkerchief or disposable tissue, using TOBACCO PRODUCTS, eating, or 

drinking; P

(E) After handling soiled EQUIPMENT or UTENSILS; P

(F) During FOOD preparation, as often as necessary to remove soil and 

contamination and to prevent cross contamination when changing tasks; P

(G) When switching between working with raw FOOD and working with 

READY-TO-EAT FOOD; P

(H) Before donning gloves to initiate a task that involves working with 

FOOD; P and

(I) After engaging in other activities that contaminate the hands.P

2-301.15 Where to Wash.

FOOD EMPLOYEES shall clean their hands in a HANDWASHING SINK or APPROVED

automatic handwashing facility and may not clean their hands in a sink used for 

FOOD preparation or WAREWASHING, or in a service sink or a curbed cleaning 

facility used for the disposal of mop water and similar liquid waste. Pf

2-301.16 Hand Antiseptics

(A) A hand antiseptic used as a topical application, a hand antiseptic solution 

used as a hand dip, or a hand antiseptic soap shall: 

(1) Comply with one of the following: 

(a) Be an APPROVED drug that is listed in the FDA publication 

Approved Drug Products with Therapeutic Equivalence 

Evaluations as an APPROVED drug based on safety and 

effectiveness; Pf or

(b) Have active antimicrobial ingredients that are listed in the FDA

monograph for OTC Health-Care Antiseptic Drug Products as an 

antiseptic handwash, Pf and

(2) Consist only of components which the intended use of each complies 

with one of the following:
FDA Food Code 2022 Chapter 2. Management and Personnel

Chapter 2 - 20

(a) A threshold of regulation exemption under 21 CFR 170.39 -

Threshold of regulation for substances used in FOOD-contact 

articles;Pf or

(b) 21 CFR 178 - Indirect FOOD Additives: Adjuvants, Production 

Aids, and Sanitizers as regulated for use as a FOOD ADDITIVE with 

conditions of safe use, Pf or

(c) A determination of generally recognized as safe (GRAS). Partial 

listings of substances with FOOD uses that are GRAS may be found 

in 21 CFR 182 - Substances Generally Recognized as Safe, 21 

CFR 184 - Direct FOOD Substances Affirmed as Generally 

Recognized as Safe, or 21 CFR 186 – Indirect FOOD Substances 

Affirmed as Generally Recognized as Safe for use in contact with 

FOOD, and in FDA’s Inventory of GRAS Notices, Pf or

(d) A prior sanction listed under 21 CFR 181 – Prior Sanctioned 

FOOD Ingredients,Pf or

(e) a FOOD Contact Notification that is effective,PF and

(3) Be applied only to hands that are cleaned as specified under 

§ 2-301.12. Pf

(B) If a hand antiseptic or a hand antiseptic solution used as a hand dip does not 

meet the criteria specified under Subparagraph (A)(2) of this section, use shall 

be: 

(1) Followed by thorough hand rinsing in clean water before hand contact 

with FOOD or by the use of gloves; Pf or

(2) Limited to situations that involve no direct contact with FOOD by the 

bare hands. Pf

 

(C) A hand antiseptic solution used as a hand dip shall be maintained clean and 

at a strength equivalent to at least 100 MG/L chlorine. Pf

2-302 Fingernails

2-302.11 Maintenance.

(A) FOOD EMPLOYEES shall keep their fingernails trimmed, filed, and maintained 

so the edges and surfaces are cleanable and not rough. Pf

(B) Unless wearing intact gloves in good repair, a FOOD EMPLOYEE may not wear 

fingernail polish or artificial fingernails when working with exposed FOOD. Pf 

2-303 Jewelry

2-303.11 Prohibition.
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Chapter 2 - 21

Except for a plain ring such as a wedding band, while preparing FOOD, FOOD 

EMPLOYEES may not wear jewelry including medical information jewelry on their 

arms and hands. 

2-304 Outer Clothing

2-304.11 Clean Condition. 

Food employees shall wear clean outer clothing to prevent contamination of 

food, equipment, utensils, linens, and single-service and single-use articles.

2-4 Hygienic Practices

2-401 Food Contamination Prevention

2-401.11 Eating, Drinking, or Using TOBACCO PRODUCTS.

(A) Except as specified in ¶ (B) of this section, an EMPLOYEE shall eat, drink, or 

use any form of TOBACCO PRODUCTS only in designated areas where the 

contamination of exposed FOOD; clean EQUIPMENT, UTENSILS, and LINENS; 

unwrapped SINGLE-SERVICE and SINGLE-USE ARTICLES; or other items needing 

protection can not result. 

(B) A FOOD EMPLOYEE may drink from a closed BEVERAGE container if the 

container is handled to prevent contamination of: 

(1) The EMPLOYEE'S hands;

(2) The container; and

(3) Exposed FOOD; clean EQUIPMENT, UTENSILS, and LINENS; and 

unwrapped SINGLE-SERVICE and SINGLE-USE ARTICLES.

2-401.12 Discharges from the Eyes, Nose, and Mouth.

FOOD EMPLOYEES experiencing persistent sneezing, coughing, or a runny nose 

that causes discharges from the eyes, nose, or mouth may not work with 

exposed FOOD; clean EQUIPMENT, UTENSILS, and LINENS; or unwrapped SINGLESERVICE or SINGLE-USE ARTICLES.

2-401.13 Use of Bandages, Finger Cots, or Finger Stalls

If used, an impermeable cover such as a bandage, finger cot or finger stall 

located on the wrist, hand or finger of a FOOD EMPLOYEE working with exposed 

FOOD shall be covered with a single-use glove.

2-402 Hair Restraints

2-402.11 Effectiveness.

(A) Except as provided in ¶ (B) of this section, FOOD EMPLOYEES shall wear hair 

restraints such as hats, hair coverings or nets, beard restraints, and clothing that 

covers body hair, that are designed and worn to effectively keep their hair from 
FDA Food Code 2022 Chapter 2. Management and Personnel

Chapter 2 - 22

contacting exposed FOOD; clean EQUIPMENT, UTENSILS, and LINENS; and 

unwrapped SINGLE-SERVICE and SINGLE-USE ARTICLES. 

(B) This section does not apply to FOOD EMPLOYEES such as counter staff who 

only serve BEVERAGES and wrapped or PACKAGED FOODS, hostesses, and wait 

staff if they present a minimal RISK of contaminating exposed FOOD; clean 

EQUIPMENT, UTENSILS, and LINENS; and unwrapped SINGLE-SERVICE and SINGLEUSE ARTICLES.

2-403 Animals

2-403.11 Handling Prohibition.

(A) Except as specified in ¶ (B) of this section, FOOD EMPLOYEES may not care for 

or handle animals that may be present such as patrol dogs, SERVICE ANIMALS, or 

pets that are allowed as specified in Subparagraphs 6-501.115(B)(2) - (5) and 

(D). Pf 

(B) FOOD EMPLOYEES with SERVICE ANIMALS may handle or care for their SERVICE 

ANIMALS and FOOD EMPLOYEES may handle or care for FISH in aquariums or 

MOLLUSCAN SHELLFISH or crustacea in display tanks if they wash their hands as 

specified under § 2-301.12 and ¶ 2-301.14(C). 

2-5 Responding To Contamination Events

2-501.11 Clean-up of Vomiting and Diarrheal Events.

A FOOD ESTABLISHMENT shall have written procedures for EMPLOYEES to follow 

when responding to vomiting or diarrheal events that involve the discharge of 

vomitus or fecal matter onto surfaces in the FOOD ESTABLISHMENT. The 

procedures shall address the specific actions EMPLOYEES must take to minimize 

the spread of contamination and the exposure of EMPLOYEES, consumers, FOOD, 

and surfaces to vomitus or fecal matter. Pf
FDA Food Code 2022 Chapter 3. Food

Chapter 3 - 1

Chapter 3 Food

Parts:

3-1 Characteristics

3-2 Sources, Specifications, and Original Containers and Records

3-3 Protection From Contamination After Receiving

3-4 Destruction of Organisms of Public Health Concern

3-5 Limitation of Growth of Organisms of Public Health Concern

3-6 Food Identity, Presentation, and On-Premises Labeling

3-7 Contaminated Food

3-8 Special Requirements for Highly Susceptible Populations

3-1 Characteristics

3-101 Condition

3-101.11 Safe, Unadulterated, and Honestly Presented.

FOOD shall be safe, unADULTERATED, and, as specified under § 3-601.12, 

honestly presented.P

3-2 Sources, Specifications, and Original Containers and Records

3-201 Sources

3-201.11 Compliance with Food Law.

(A) FOOD shall be obtained from sources that comply with LAW.

P

(B) FOOD prepared in a private home may not be used or offered for human 

consumption in a FOOD ESTABLISHMENT. P(C) PACKAGED FOOD shall be labeled as 

specified in LAW, including 21 CFR 101 FOOD Labeling, 9 CFR 317 Labeling, 

Marking Devices, and Containers, and 9 CFR 381 Subpart N Labeling and 

Containers, and as specified under §§ 3-202.17 and 3-202.18. Pf

(C) PACKAGED FOOD shall be labeled as specified in LAW, including 21 CFR 101 

FOOD Labeling, 9 CFR 317 Labeling, Marking Devices, and Containers, and 9 

CFR 381 Subpart N Labeling and Containers, and as specified under § 3-202.18.

(D) FISH, other than those specified in paragraph 3-402.11(B), that are intended 

for consumption in raw or undercooked form and allowed as specified in 

paragraph 3-401.11(D), may be offered for sale or service if they are obtained 

from a supplier that freezes the FISH as specified under § 3-402.11; or if they are 

frozen on the PREMISES as specified under § 3-402.11 and records are retained 

as specified under § 3-402.12. 
FDA Food Code 2022 Chapter 3. Food

Chapter 3 - 2

(E) WHOLE-MUSCLE, INTACT BEEF steaks that are intended for consumption in an 

undercooked form without a CONSUMER advisory as specified in ¶ 3-401.11(C) 

shall be:

(1) Obtained from a FOOD PROCESSING PLANT that does not MECHANICALLY 

TENDERIZE, vacuum tumble with solutions, reconstruct, cube or pound 

these WHOLE-MUSCLE, INTACT BEEF steaks, Pf or

(2) Deemed acceptable by the REGULATORY AUTHORITY based on other 

evidence, such as written buyer specifications or invoices, that indicates 

that the steaks meet the definition of WHOLE-MUSCLE, INTACT BEEF, Pf and

(3) If individually cut in a FOOD ESTABLISHMENT: 

(a) Cut from WHOLE-MUSCLE INTACT BEEF that is recieved from a 

FOOD PROCESSING PLANT as specified in Subparagraph (E)(1) of this 

section or identified as specified in Subparagraph (E)(2) of this 

section, P

(b) Prepared so they remain intact, Pf and

(F) MEAT and POULTRY that is not a READY-TO-EAT FOOD and is in a PACKAGED form 

when it is offered for sale or otherwise offered for consumption, shall be labeled 

to include safe handling instructions as specified in LAW, including 9 CFR 317.2(l) 

and 9 CFR 381.125(b).

(G) EGGS that have not been specifically treated to destroy all viable 

Salmonellae shall be labeled to include safe handling instructions as specified in 

LAW, including 21 CFR 101.17(h). 

3-201.12 Food in a Hermetically Sealed Container.

FOOD in a HERMETICALLY SEALED CONTAINER shall be obtained from a FOOD

PROCESSING PLANT that is regulated by the FOOD regulatory agency that has 

jurisdiction over the plant. P

3-201.13 Fluid Milk and Milk Products.

Fluid milk and milk products shall be obtained from sources that comply with 

GRADE A STANDARDS as specified in LAW. P 

3-201.14 Fish.

(A) FISH that are received for sale or service shall be: 

(1) Commercially and legally caught or harvested; P or

(2) APPROVED for sale or service. P

(B) MOLLUSCAN SHELLFISH that are recreationally caught may not be received for 

sale or service. P
FDA Food Code 2022 Chapter 3. Food

Chapter 3 - 3

3-201.15 Molluscan Shellfish.

(A) MOLLUSCAN SHELLFISH shall be obtained from sources according to LAW and 

the requirements specified in the U.S. Department of Health and Human 

Services, Public Health Service, Food and Drug Administration, National 

Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish. P

(B) MOLLUSCAN SHELLFISH received in interstate commerce shall be from sources 

that are listed in the Interstate Certified Shellfish Shippers List. P

3-201.16 Wild Mushrooms.

(A) Except as specified in ¶ (B) of this section, mushroom species picked in the 

wild shall not be offered for sale or service by a FOOD ESTABLISHMENT unless the 

FOOD ESTABLISHMENT has been APPROVED to do so. P

(B) This section does not apply to:

(1) Cultivated wild mushroom species that are grown, harvested, and 

processed in an operation that is regulated by the FOOD regulatory agency 

that has jurisdiction over the operation; or

(2) Wild mushroom species if they are in packaged form and are the 

product of a FOOD PROCESSING PLANT that is regulated by the FOOD

regulatory agency that has jurisdiction over the plant.

3-201.17 Game Animals.

(A) If GAME ANIMALS are received for sale or service they shall be:

(1) Commercially raised for FOOD P and:

(a) Raised, slaughtered, and processed under a voluntary 

inspection program that is conducted by the agency that has animal 

health jurisdiction, P or

(b) Under a routine inspection program conducted by a regulatory 

agency other than the agency that has animal health jurisdiction, P

and

(c) Raised, slaughtered, and processed according to:

(i) LAWS governing MEAT and POULTRY as determined by the 

agency that has animal health jurisdiction and the agency 

that conducts the inspection program, P and

(ii) Requirements which are developed by the agency that 

has animal health jurisdiction and the agency that conducts 

the inspection program with consideration of factors such as 

the need for antemortem and postmortem examination by an 

APPROVED veterinarian or veterinarian’s designee; P

(2) Under a voluntary inspection program administered by the USDA for 

game animals such as exotic animals (reindeer, elk, deer, antelope, water 

buffalo, or bison) that are "inspected and APPROVED" in accordance with 9 

CFR 352 Exotic Animals; Voluntary Inspection or rabbits that are 
FDA Food Code 2022 Chapter 3. Food

Chapter 3 - 4

"inspected and certified" in accordance with 9 CFR 354 Voluntary 

Inspection of Rabbits and Edible Products Thereof; P 

(3) As allowed by LAW, for wild GAME ANIMALS that are live-caught:

(a) Under a routine inspection program conducted by a regulatory 

agency such as the agency that has animal health jurisdiction, P and

(b) Slaughtered and processed according to:

(i) LAWS governing MEAT and POULTRY as determined by the 

agency that has animal health jurisdiction and the agency 

that conducts the inspection program, P and

(ii) Requirements which are developed by the agency that 

has animal health jurisdiction and the agency that conducts 

the inspection program with consideration of factors such as 

the need for antemortem and postmortem examination by an 

APPROVED veterinarian or veterinarian’s designee; P or

(4) As allowed by LAW, for field-dressed wild GAME ANIMALS under a routine 

inspection program that ensures the animals: 

(a) Receive a postmortem examination by an APPROVED veterinarian 

or veterinarian's designee, P or

(b) Are field-dressed and transported according to requirements 

specified by the agency that has animal health jurisdiction and the 

agency that conducts the inspection program, P and

(c) Are processed according to LAWS governing MEAT and POULTRY

as determined by the agency that has animal health jurisdiction and 

the agency that conducts the inspection program. P

(B) A GAME ANIMAL may not be received for sale or service if it is a species 

of wildlife that is listed in 50 CFR 17 Endangered and threatened wildlife 

and plants.

3-202 Specifications for Receiving

3-202.11 Temperature.

(A) Except as specified in ¶ (B) of this section, refrigerated, TIME/TEMPERATURE 

CONTROL FOR SAFETY FOOD shall be at a temperature of 5oC (41oF) or below when 

received. P

(B) If a temperature other than 5°C (41°F) for a TIME/TEMPERATURE CONTROL FOR 

SAFETY FOOD is specified in LAW governing its distribution, such as LAWS

governing milk and MOLLUSCAN SHELLFISH, the FOOD may be received at the 

specified temperature.

(C) Raw EGGS shall be received in refrigerated equipment that maintains an 

ambient air temperature of 7oC (45oF) or less. P
FDA Food Code 2022 Chapter 3. Food

Chapter 3 - 5

(D) TIME/TEMPERATURE CONTROL FOR SAFETY FOOD that is cooked to a temperature 

and for a time specified under §§ 3-401.11 - 3-401.13 and received hot shall be 

at a temperature of 57oC (135oF) or above. P 

(E) A FOOD that is labeled frozen and shipped frozen by a FOOD PROCESSING 

PLANT shall be received frozen. Pf 

(F) Upon receipt, TIME/TEMPERATURE CONTROL FOR SAFETY FOOD shall be free of 

evidence of previous temperature abuse. Pf 

3-202.12 Additives.

FOOD may not contain unAPPROVED FOOD ADDITIVES or ADDITIVES that exceed 

amounts specified in 21 CFR 170-180 relating to FOOD ADDITIVES, generally 

recognized as safe or prior sanctioned substances that exceed amounts 

specified in 21 CFR 181-186, substances that exceed amounts specified in 9 

CFR Subpart C Section 424.21(b) FOOD ingredients and sources of radiation, or 

pesticide residues that exceed provisions specified in 40 CFR 180 Tolerances for 

pesticides chemicals in FOOD, and exceptions. P

3-202.13 Eggs.

EGGS shall be received clean and sound and may not exceed the restricted EGG

tolerances for U.S. Consumer Grade B as specified in United States Standards, 

Grades, and Weight Classes for Shell Eggs, AMS 56.200 et seq., administered 

by the Agricultural Marketing Service of USDA. P

3-202.14 Eggs and Milk Products, Pasteurized.

(A) EGG PRODUCTS shall be obtained pasteurized. P

(B) Fluid and dry milk and milk products shall:

(1) Be obtained pasteurized; P and

(2) Comply with GRADE A STANDARDS as specified in LAW. P 

(C) Frozen milk products, such as ice cream, shall be obtained pasteurized as 

specified in 21 CFR 135 - Frozen desserts. P

(D) Cheese shall be obtained pasteurized unless alternative procedures to 

pasteurization are specified in the CFR, such as 21 CFR 133 - Cheeses and 

related cheese products, for curing certain cheese varieties. P 

3-202.15 Package Integrity.

FOOD packages shall be in good condition and protect the integrity of the 

contents so that the FOOD is not exposed to ADULTERATION or potential 

contaminants. Pf

3-202.16 Ice.

Ice for use as a FOOD or a cooling medium shall be made from DRINKING WATER. P
FDA Food Code 2022 Chapter 3. Food

Chapter 3 - 6

3-202.17 Shellstock, Condition. 

When received by a FOOD ESTABLISHMENT, SHELLSTOCK shall be reasonably free 

of mud, dead SHELLSTOCK, and SHELLSTOCK with broken shells. Dead 

SHELLSTOCK with badly broken shells shall be discarded. 

Packaging and Identification

3-202.18 Molluscan Shellfish, Packaging and Identification. 

(A) Except as specified in sub ¶ (B)(1) of this section, MOLLUSCAN SHELLFISH shall 

be obtained in nonreturnable packages or containers which bear a legible tag or 

label that identifies the: Pf 

(1) Source, and are affixed by a dealer that depurates, packs, ships or 

reships the MOLLUSCAN SHELLFISH, as specified in the National Shellfish 

Sanitation Program (NSSP) Guide for the Control of MOLLUSCAN SHELLFISH

(Model Ordinance) ; Pf and 

(2) "Sell by" or "best if used by" date for SHUCKED SHELLFISH PACKAGES with 

a capacity of less than 1.89 L (one-half gallon) or the date shucked for 

PACKAGES with a capacity of 1.89 L (one-half gallon) or more. Pf

(B) When a two-tag harvester or DEALER system is used, the DEALER tag shall 

meet the requirements identified in (A)(1) of this section.

1) When both the DEALER and harvester tags appear on the container, the 

DEALER’S tag is not required to duplicate the information on the 

harvester’s tag.

(C) A container of raw MOLLUSCAN SHELLFISH that does not bear a tag or label or 

which bears a tag or label which does not contain all the information as specified 

under the Model Ordinance shall be subject to a hold order, as allowed by LAW, 

or seizure and destruction in accordance with 21 CFR Subpart D - Specific 

Administrative Decisions Regarding Interstate Shipments, Section 1240.60(d). 

Commercially processed

3-202.110 Juice Treated. 

Pre-packaged juice shall: 

(A) Be obtained from a processor with a HACCP system as specified in 21 

CFR Part 120 Hazard Analysis and Critical Control (HACCP) Systems; Pf

and

(B) Be obtained pasteurized or otherwise treated to attain a 5-log 

reduction of the most resistant microorganism of public health significance 

as specified in 21 CFR Part 120.24 Process Controls. P

3-203 Original Containers and Records

3-203.11 Molluscan Shellfish, Original Container. 
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(A) Except as specified in ¶¶ (C) - (E) of this section, MOLLUSCAN SHELLFISH may 

not be removed from the container in which they are received other than 

immediately before sale or preparation for service. 

(B) MOLLUSCAN SHELLFISH from one tagged or labeled container shall not be 

COMMINGLED with MOLLUSCAN SHELLFISH from another container with different 

CERTIFICATION NUMBERS, different harvest dates, or different growing areas 

identified on the tag or label before being ordered by the CONSUMER. Pf

(C) For display purposes, SHELLSTOCK or IN-SHELL PRODUCT may be removed from 

the container in which they are received, displayed on drained ice, or held in a 

display container, and a quantity specified by a CONSUMER may be removed from 

the display or display container and provided to the CONSUMER if: 

(1) The source of the SHELLSTOCK or IN-SHELL PRODUCT on display is 

identified as specified under § 3-202.18 and recorded as specified under 

§ 3-203.12; and

(2) The SHELLSTOCK or IN-SHELL PRODUCT are protected from 

contamination.

(D) SHUCKED SHELLFISH may be removed from the container in which they were 

received and held in a display container from which individual servings are 

dispensed upon a CONSUMER'S request if: 

(1) The labeling information for the shellfish on display as specified under 

§ 3-202.18 is retained and correlated to the date when, or dates during 

which, the shellfish are sold or served; and

(2) The shellfish are protected from contamination. 

(E) SHUCKED SHELLFISH may be removed from the container in which they were 

received and repacked in CONSUMER self service containers where allowed by 

LAW if: 

(1) The labeling information for the shellfish is on each CONSUMER self 

service container as specified under § 3-202.18 and ¶¶ 3-602.11(A) and 

(B)(1) - (5);

(2) The labeling information as specified under § 3-202.18 is retained and 

correlated with the date when, or dates during which, the shellfish are sold 

or served;

(3) The labeling information and dates specified under Subparagraph 

(E)(2) of this section are maintained for 90 days; and

(4) The shellfish are protected from contamination. 

3-203.12 Molluscan Shellfish, Maintaining Identification.

(A) Except as specified under Subparagraph (C) (2) of this section, MOLLUSCAN 

SHELLFISH tags or labels shall remain attached to the container in which the 

shellstock are received until the container is empty; Pf and
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(B) The date when the last MOLLUSCAN SHELLFISH from the container is sold or 

served shall be recorded on the tag, label, or invoice; Pf and

(C) The identity of the source of MOLLUSCAN SHELLFISH that are sold or served 

shall be maintained by retaining product tags, labels, or invoices for 90 calendar 

days from the date that is recorded on the tag, label, or invoice as specified 

under ¶ B of this section, by: Pf

(1) Using an APPROVED record keeping system that keeps the tags, labels, 

or invoice in chronological order correlated to the date that is recorded on 

the tag, label, or invoice as specified under ¶ B of this section; Pf and

(2) If SHELLSTOCK, SHUCKED SHELLFISH or IN-SHELL PRODUCT are removed 

from its tagged or labeled container the source identification will be 

preserved by using a record keeping system as specified under

Subparagraph (C)(1) of this section. Pf

3-204 Food Donation

3-204.10 Food Donation. 

FOOD stored, prepared, PACKAGED, displayed, and labeled in accordance to LAW

and this Code may be offered for donation.

3-3 Protection From Contamination After Receiving

3-301 Preventing Contamination by Employees

3-301.11 Preventing Contamination from Hands.

(A) FOOD EMPLOYEES shall wash their hands as specified under § 2-301.12. 

(B) Except when washing fruits and vegetables as specified under §3-302.15 or 

as specified in ¶¶ (D) and (E) of this section, FOOD EMPLOYEES may not contact 

exposed, READY-TO-EAT FOOD with their bare hands and shall use suitable 

UTENSILS such as deli tissue, spatulas, tongs, single-use gloves, or dispensing 

EQUIPMENT. P 

(C) FOOD EMPLOYEES shall minimize bare hand and arm contact with exposed 

FOOD that is not in a READY-TO-EAT form. Pf

(D) Paragraph (B) of this section does not apply to a FOOD EMPLOYEE that 

contacts exposed, READY-TO-EAT FOOD with bare hands at the time the READY-TOEAT FOOD is being added as an ingredient to a FOOD that:

(1) contains a raw animal FOOD and is to be cooked in the FOOD 

ESTABLISHMENT to heat all parts of the FOOD to the minimum temperatures 

specified in ¶¶3-401.11(A)-(B) or §3-401.12; or

(2) does not contain a raw animal FOOD but is to be cooked in the FOOD 

ESTABLISHMENT to heat all parts of the FOOD to a temperature of at least 

63°C (145°F).
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(E) FOOD EMPLOYEES not serving a HIGHLY SUSCEPTIBLE POPULATION may contact 

exposed, READY-TO-EAT FOOD with their bare hands if: 

(1) The permit holder obtains prior approval from the regulatory authority;

(2) Written procedures are maintained in the food establishment and made 

available to the regulatory authority upon request that include: 

(a) For each bare hand contact procedure, a listing of the specific 

READY-TO-EAT FOODS that are touched by bare hands,

(b) Diagrams and other information showing that handwashing 

facilities, installed, located, equipped, and maintained as specified 

under §§ 5-203.11, 5-204.11, 5-205.11, 6-301.11, 6-301.12, and 6-

301.14, are in an easily accessible location and in close proximity to 

the work station where the bare hand contact procedure is 

conducted; 

(3) A written EMPLOYEE health policy that details how the FOOD 

ESTABLISHMENT complies with §§ 2-201.11, 2-201.12, and 2-201.13 

including:

(a) Documentation that FOOD EMPLOYEES and CONDITIONAL 

EMPLOYEES acknowledge that they are informed to report 

information about their health and activities as they relate to 

gastrointestinal symptoms and diseases that are transmittable 

through FOOD as specified under ¶ 2-201.11(A),

(b) Documentation that FOOD EMPLOYEES and CONDITIONAL 

EMPLOYEES acknowledge their responsibilities as specified under ¶ 

2-201.11(E) and (F), and

(c) Documentation that the PERSON IN CHARGE acknowledges the 

responsibilities as specified under ¶¶ 2-201.11(B), (C) and (D), and 

§§ 2-201.12 and 2-201.13;

(4) Documentation that FOOD EMPLOYEES acknowledge that they have 

received training in: 

(a) The RISKS of contacting the specific READY-TO-EAT FOODS with 

bare hands,

(b) Proper handwashing as specified under § 2-301.12,

(c) When to wash their hands as specified under § 2-301.14,

(d) Where to wash their hands as specified under § 2-301.15,

(e) Proper fingernail maintenance as specified under § 2-302.11,

(f) Prohibition of jewelry as specified under § 2-303.11, and 

(g) Good hygienic practices as specified under §§2-401.11 and 2-

401.12;
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(5) Documentation that hands are washed before FOOD preparation and as 

necessary to prevent cross contamination by FOOD EMPLOYEES as 

specified under §§ 2-301.11, 2-301.12, 2-301.14, and 2-301.15 during all 

hours of operation when the specific READY-TO-EAT FOODS are prepared; 

(6) Documentation that FOOD EMPLOYEES contacting READY-TO-EAT FOOD

with bare hands use two or more of the following control measures to 

provide additional safeguards to HAZARDS associated with bare hand 

contact: 

(a) Double handwashing,

(b) Nail brushes,

(c) A hand antiseptic after handwashing as specified under 

§ 2-301.16,

(d) Incentive programs such as paid sick leave that assist or 

encourage food employees not to work when they are ill, or 

(e) Other control measures approved by the regulatory authority; 

and

(7) Documentation that corrective action is taken when Subparagraphs 

(E)(1) - (6) of this section are not followed.

3-301.12 Preventing Contamination When Tasting.

A FOOD EMPLOYEE may not use a UTENSIL more than once to taste FOOD that is to 

be sold or served. P 

3-302 Preventing food and ingredient contamination

3-302.11 Packaged and Unpackaged Food - Separation, Packaging, and 

Segregation.

(A) FOOD shall be protected from cross contamination by:

(1) Except as specified in (1)(d) below or when combined as ingredients, 

separating raw animal FOODS during storage, preparation, holding, and 

display from:

(a) Raw READY-TO-EAT FOOD including other raw animal FOOD such 

as FISH for sushi or MOLLUSCAN SHELLFISH, or other raw READY-TOEAT FOOD such as fruits and vegetables,P

(b) Cooked READY-TO-EAT FOOD, P and

(c) Fruits and vegetables before they are washed; P

(d) Frozen, commercially processed and packaged raw animal FOOD

may be stored or displayed with or above frozen, commercially 

processed and packaged, ready-to-eat food.
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(2) Except when combined as ingredients, separating types of raw animal 

FOODS from each other such as beef, FISH, lamb, pork, and POULTRY during 

storage, preparation, holding, and display by: 

(a) Using separate EQUIPMENT for each type, P or

(b) Arranging each type of FOOD in EQUIPMENT so that cross 

contamination of one type with another is prevented, P and

(c) Preparing each type of FOOD at different times or in separate 

areas; P

(3) Cleaning equipment and utensils as specified under ¶ 4-602.11(A) and 

sanitizing as specified under § 4-703.11;

(4) Except as specified under Subparagraph 3-501.15(B)(2) and in ¶ (B) of 

this section, storing the food in packages, covered containers, or 

wrappings;

(5) Cleaning hermetically sealed containers of food of visible soil before 

opening;

(6) Protecting food containers that are received packaged together in a 

case or overwrap from cuts when the case or overwrap is opened;

(7) Storing damaged, spoiled, or recalled food being held in the food 

establishment as specified under § 6-404.11; and

(8) Separating fruits and vegetables, before they are washed as specified 

under § 3-302.15 from READY-TO-EAT FOOD.

(B) Subparagraph (A)(4) of this section does not apply to:

(1) Whole, uncut, raw fruits and vegetables and nuts in the shell, that 

require peeling or hulling before consumption;

(2) PRIMAL CUTS, quarters, or sides of raw MEAT or slab bacon that are 

hung on clean, SANITIZED hooks or placed on clean, SANITIZED racks;

(3) Whole, uncut, processed MEATS such as country hams, and smoked or 

cured sausages that are placed on clean, SANITIZED racks;

(4) FOOD being cooled as specified under Subparagraph 3-501.15(B)(2); or

(5) SHELLSTOCK. 

3-302.12 Food Storage Containers, Identified with Common Name of 

Food. 

Except for containers holding FOOD that can be readily and unmistakably 

recognized such as dry pasta, working containers holding FOOD or FOOD

ingredients that are removed from their original packages for use in the FOOD

ESTABLISHMENT, such as cooking oils, flour, herbs, potato flakes, salt, spices, and 

sugar shall be identified with the common name of the FOOD. 
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3-302.13 Pasteurized Eggs, Substitute for Raw Eggs for Certain Recipes.

Pasteurized EGGS or EGG PRODUCTS shall be substituted for raw EGGS in the 

preparation of FOODS such as Caesar salad, hollandaise or Béarnaise sauce, 

mayonnaise, meringue, eggnog, ice cream, and EGG-fortified BEVERAGES that are 

not: P

(A) Cooked as specified under Subparagraphs 3-401.11(A)(1) or (2); P or

(B) Included in ¶ 3-401.11(D). P

3-302.14 Protection from Unapproved Additives.

(A) FOOD shall be protected from contamination that may result from the addition 

of, as specified in § 3-202.12: 

(1) Unsafe or unapproved food or color additives; P and

(2) Unsafe or unapproved levels of approved food and color additives. P

(B) A FOOD EMPLOYEE may not: 

(1) Apply sulfiting agents to fresh fruits and vegetables intended for raw 

consumption or to a FOOD considered to be a good source of vitamin B1; P

or

(2) Except for grapes, serve or sell FOOD specified under Subparagraph 

(B)(1) of this section that is treated with sulfiting agents before receipt by 

the FOOD ESTABLISHMENT. P

3-302.15 Washing Fruits and Vegetables. 

(A) Except as specified in ¶ (B) of this section and except for whole, raw fruits 

and vegetables that are intended for washing by the CONSUMER before 

consumption, raw fruits and vegetables shall be thoroughly washed in water to 

remove soil and other contaminants before being cut, combined with other 

ingredients, cooked, served, or offered for human consumption in READY-TO-EAT

form. 

(B) Fruits and vegetables may be washed by using chemicals as specified under 

§ 7-204.12 and a test kit or other device that accurately measures the active 

ingredient concentration of the fruit and vegetable wash solution may be 

provided.

(C) Devices used for on-site generation of chemicals meeting the requirements 

specified in 21 CFR 173.315, Chemicals used in the washing or to assist in the 

peeling of fruits and vegetables, for the washing of raw, whole fruits and 

vegetables shall be used in accordance with the manufacturer’s instructions. Pf

3-303 Preventing Contamination from Ice Used As a Coolant

3-303.11 Ice Used as Exterior Coolant, Prohibited as Ingredient. 
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After use as a medium for cooling the exterior surfaces of FOOD such as melons 

or FISH, PACKAGED FOODS such as canned BEVERAGES, or cooling coils and tubes 

of EQUIPMENT, ice may not be used as FOOD. P 

3-303.12 Storage or Display of Food in Contact with Water or Ice. 

(A) PACKAGED FOOD may not be stored in direct contact with ice or water if the 

FOOD is subject to the entry of water because of the nature of its packaging, 

wrapping, or container or its positioning in the ice or water

(B) Except as specified in ¶¶ (C) and (D) of this section, unPACKAGED FOOD may 

not be stored in direct contact with undrained ice. 

(C) Whole, raw fruits or vegetables; cut, raw vegetables such as celery or carrot 

sticks or cut potatoes; and tofu may be immersed in ice or water. 

(D) Raw poultry and raw FISH that are received immersed in ice in shipping 

containers may remain in that condition while in storage awaiting preparation, 

display, service, or sale. 

3-304 Preventing Contamination from Equipment, Utensils, and Linens

3-304.11 Food Contact with Equipment and Utensils.

FOOD shall only contact surfaces of:

(A) EQUIPMENT and UTENSILS that are cleaned as specified under Part 4-6 

of this Code and SANITIZED as specified under Part 4-7 of this Code; P

(B) Single-service and single-use articles; P or

(C) LINENS, such as cloth napkins, as specified under § 3-304.13 that are 

laundered as specified under Part 4-8 of this Code. P

3-304.12 In-Use Utensils, Between-Use Storage. 

During pauses in FOOD preparation or dispensing, FOOD preparation and 

dispensing UTENSILS shall be stored:

(A) Except as specified under ¶ (B) of this section, in the food with their 

handles above the top of the food and the container;

(B) In food that is not time/temperature control for safety food with their 

handles above the top of the food within containers or equipment that can 

be closed, such as bins of sugar, flour, or cinnamon;

(C) On a clean portion of the food preparation table or cooking equipment 

only if the in-use utensil and the food-contact surface of the food 

preparation table or cooking equipment are cleaned and sanitized at a 

frequency specified under §§ 4-602.11 and 4-702.11;

(D) In running water of sufficient velocity to flush particulates to the drain, 

if used with moist food such as ice cream or mashed potatoes;
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(E) In a clean, protected location if the utensils, such as ice scoops, are 

used only with a food that is not time/temperature control for safety food; 

or

(F) In a container of water if the water is maintained at a temperature of at 

least 57oC (135oF) and the container is cleaned at a frequency specified 

under Subparagraph 4-602.11(D)(7).

3-304.13 Linens and Napkins, Use Limitation.

LINENS, such as cloth napkins, may not be used in contact with FOOD unless they 

are used to line a container for the service of FOODS and the LINENS and napkins 

are replaced each time the container is refilled for a new CONSUMER.

3-304.14 Wiping Cloths, Use Limitation.

(A) Cloths in-use for wiping FOOD spills from TABLEWARE and carry-out containers 

that occur as FOOD is being served shall be:

(1) Maintained dry; and

(2) Used for no other purpose. 

(B) Cloths in-use for wiping counters and other EQUIPMENT surfaces shall be: 

(1) Held between uses in a chemical sanitizer solution at a concentration 

specified under § 4-501.114; and

(2) Laundered daily as specified under ¶ 4-802.11(D).

(C) Cloths in-use for wiping surfaces in contact with raw animal FOODS shall be 

kept separate from cloths used for other purposes. 

(D) Dry wiping cloths and the chemical sanitizing solutions specified in 

Subparagraph (B)(1) of this section in which wet wiping cloths are held between 

uses shall be free of FOOD debris and visible soil. 

(E) Containers of chemical sanitizing solutions specified in Subparagraph (B)(1) 

of this section in which wet wiping cloths are held between uses shall be stored 

off the floor and used in a manner that prevents contamination of FOOD,

EQUIPMENT, UTENSILS, LINENS, SINGLE-SERVICE, or SINGLE-USE ARTICLES.

(F) SINGLE-USE disposable sanitizer wipes shall be used in accordance with EPAapproved manufacturer’s label use instructions. 

3-304.15 Gloves, Use Limitation.

(A) If used, single-use gloves shall be used for only one task such as working with 

ready-to-eat food or with raw animal food, used for no other purpose, and 

discarded when damaged or soiled, or when interruptions occur in the operation.P 

(B) Except as specified in ¶ (C) of this section, slash-resistant gloves that are 

used to protect the hands during operations requiring cutting shall be used in 

direct contact only with FOOD that is subsequently cooked as specified under Part 

3-4 such as frozen FOOD or a PRIMAL CUT of MEAT.
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(C) Slash-resistant gloves may be used with READY-TO-EAT FOOD that will not be 

subsequently cooked if the slash-resistant gloves have a SMOOTH, durable, and 

nonabsorbent outer surface; or if the slash-resistant gloves are covered with a 

SMOOTH, durable, nonabsorbent glove, or a SINGLE-USE glove. 

(D) Cloth gloves may not be used in direct contact with FOOD unless the FOOD is 

subsequently cooked as required under Part 3-4 such as frozen FOOD or a PRIMAL 

CUT of MEAT. 

3-304.16 Using Clean Tableware for Second Portions and Refills. 

(A) Except for refilling a CONSUMER’S drinking cup or container without contact 

between the pouring UTENSIL and the lip-contact area of the drinking cup or 

container, FOOD EMPLOYEES may not use TABLEWARE, including SINGLE-SERVICE

ARTICLES, soiled by the CONSUMER, to provide second portions or refills. 

(B) Except as specified in ¶ (C) of this section, self-service CONSUMERS may not 

be allowed to use soiled TABLEWARE, including SINGLE-SERVICE ARTICLES, to obtain 

additional FOOD from the display and serving EQUIPMENT. 

(C) Drinking cups and containers may be reused by self-service CONSUMERS if 

refilling is a contamination-free process as specified under ¶¶ 4-204.13(A), (B), 

and (D).

3-304.17 Refilling Returnables. 

(A) Except as specified in ¶¶ (B) - (E) of this section, empty containers returned 

to a FOOD ESTABLISHMENT for cleaning and refilling with FOOD shall be cleaned and 

refilled in a regulated FOOD PROCESSING PLANT. P

(B) A take-home FOOD container returned to a FOOD ESTABLISHMENT may be 

refilled at a FOOD ESTABLISHMENT with FOOD if the FOOD container is: 

(1) Designed and constructed for reuse and in accordance with the 

requirements specified under Part 4-1 and 4-2; P

(2) One that was initially provided by the FOOD ESTABLISHMENT to the 

CONSUMER, either empty or filled with FOOD by the FOOD ESTABLISHMENT, for 

the purpose of being returned for reuse;

(3) Returned to the FOOD ESTABLISHMENT by the CONSUMER after use;

(4) Subject to the following steps before being refilled with FOOD:

(a) Cleaned as specified under Part 4-6 of this Code,

(b) Sanitized as specified under Part 4-7 of this Code; P and

(c) Visually inspected by a FOOD EMPLOYEE to verify that the 

container, as returned, meets the requirements specified under 

Part 4-1 and 4-2. P

(C) A take-home FOOD container returned to a FOOD ESTABLISHMENT may be 

refilled at a FOOD ESTABLISHMENT with BEVERAGE if:

(1) The beverage is not a time/temperature control for safety food;
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(2) The design of the container and of the rinsing equipment and the 

nature of the beverage, when considered together, allow effective cleaning 

at home or in the food establishment;

(3) Facilities for rinsing before refilling returned containers with fresh, hot 

water that is under pressure and not recirculated are provided as part of 

the dispensing system;

(4) The consumer-owned container returned to the food establishment for 

refilling is refilled for sale or service only to the same consumer; and

(5) The container is refilled by:

(a) An EMPLOYEE of the FOOD ESTABLISHMENT, or

(b) The owner of the container if the BEVERAGE system includes a 

contamination-free transfer process as specified under ¶¶ 4-

204.13(A), (B), and (D) that cannot be bypassed by the container 

owner.

(D) Consumer-owned, personal take-out BEVERAGE containers, such as 

thermally insulated bottles, nonspill coffee cups, and promotional 

BEVERAGE glasses, may be refilled by EMPLOYEES or the CONSUMER if 

refilling is a contamination-free process as specified under ¶¶ 4-204.13(A), 

(B), and (D).

(E) CONSUMER-owned containers that are not FOOD-specific may be filled at 

a water VENDING MACHINE or system.

3-305 Preventing contamination from the premises

3-305.11 Food Storage. 

(A) Except as specified in ¶¶ (B) and (C) of this section, FOOD shall be protected 

from contamination by storing the FOOD: 

(1) In a clean, dry location;

(2) Where it is not exposed to splash, dust, or other contamination; and

(3) At least 15 cm (6 inches) above the floor.

(B) FOOD in packages and working containers may be stored less than 15 cm (6 

inches) above the floor on case lot handling EQUIPMENT as specified under § 

4-204.122.

(C) Pressurized BEVERAGE containers, cased FOOD in waterproof containers such 

as bottles or cans, and milk containers in plastic crates may be stored on a floor 

that is clean and not exposed to floor moisture. 

3-305.12 Food Storage, Prohibited Areas.

FOOD may not be stored: 

(A) In locker rooms;

(B) In toilet rooms; Pf
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(C)In dressing rooms;

(D)In garbage rooms;

(E) In mechanical rooms;

(F) Under sewer lines that are not shielded to intercept potential drips;

(G)Under leaking water lines, including leaking automatic fire sprinkler 

heads, or under lines on which water has condensed;

(H)Under open stairwells; or

(I) Under other sources of contamination.

3-305.13 Vended Time/Temperature Control for Safety Food, Original 

Container.

TIME/TEMPERATURE CONTROL FOR SAFETY FOOD dispensed through a VENDING 

MACHINE shall be in the PACKAGE in which it was placed at the FOOD

ESTABLISHMENT or FOOD PROCESSING PLANT at which it was prepared.

3-305.14 Food Preparation. 

During preparation, unPACKAGED FOOD shall be protected from environmental 

sources of contamination. 

3-306 Preventing contamination by consumers

3-306.11 Food Display.

Except for nuts in the shell and whole, raw fruits and vegetables that are 

intended for hulling, peeling, or washing by the CONSUMER before consumption,

FOOD on display shall be protected from contamination by the use of PACKAGING; 

counter, service line, or salad bar FOOD guards; display cases; or other effective 

means. P

3-306.12 Condiments, Protection. 

(A) Condiments shall be protected from contamination by being kept in 

dispensers that are designed to provide protection, protected FOOD displays 

provided with the proper UTENSILS, original containers designed for dispensing, or 

individual PACKAGES or portions.

(B) Condiments at a VENDING MACHINE LOCATION shall be in individual PACKAGES

or provided in dispensers that are filled at an APPROVED location, such as the 

FOOD ESTABLISHMENT that provides FOOD to the VENDING MACHINE LOCATION, a 

FOOD PROCESSING PLANT that is regulated by the agency that has jurisdiction over 

the operation, or a properly equipped facility that is located on the site of the 

VENDING MACHINE LOCATION. 

3-306.13 Consumer Self-Service Operations.

(A) Raw, unPACKAGED animal FOOD, such as beef, lamb, pork, POULTRY, and FISH

may not be offered for CONSUMER self-service. P This paragraph does not apply 

to: 
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(1) CONSUMER self-service of READY-TO-EAT FOODS at buffets or salad bars 

that serve FOODS such as sushi or raw shellfish;

(2) Ready-to-cook individual portions for immediate cooking and 

consumption on the PREMISES such as CONSUMER-cooked MEATS or 

CONSUMER-selected ingredients for Mongolian barbecue; or 

(3) Raw, frozen, shell-on shrimp, or lobster. 

(B) CONSUMER self-service operations for READY-TO-EAT FOODS shall be provided 

with suitable UTENSILS or effective dispensing methods that protect the FOOD from 

contamination. Pf

(C) CONSUMER self-service operations such as buffets and salad bars shall be 

monitored by FOOD EMPLOYEES trained in safe operating procedures. Pf

3-306.14 Returned Food and Re-Service of Food.

(A) Except as specified in ¶ (B) of this section, after being served or sold and in 

the possession of a CONSUMER, FOOD that is unused or returned by the CONSUMER

may not be offered as FOOD for human consumption. P 

(B) Except as specified under ¶ 3-801.11(G), a container of FOOD that is not 

TIME/TEMPERATURE CONTROL FOR SAFETY FOOD may be RE-SERVED from one 

CONSUMER to another if: 

(1) The FOOD is dispensed so that it is protected from contamination and 

the container is closed between uses, such as a narrow-neck bottle 

containing catsup, steak sauce, or wine; or

(2) The FOOD, such as crackers, salt, or pepper, is in an unopened original 

PACKAGE and is maintained in sound condition.

3-307 Preventing Contamination from Other Sources

3-307.11 Miscellaneous Sources of Contamination.

FOOD shall be protected from contamination that may result from a factor or 

source not specified under Subparts 3-301 - 3-306. 

3-4 Destruction of Organisms of Public Health Concern

3-401 Cooking

3-401.11 Raw Animal Foods.

(A) Except as specified under ¶ (B) and in ¶¶ (C) and (D) of this section, raw 

animal FOODS such as EGGS, FISH, MEAT, POULTRY, and FOODS containing these 

raw animal FOODS, shall be cooked to heat all parts of the FOOD to a temperature 

and for a time that complies with one of the following methods based on the FOOD

that is being cooked: 

(1) 63oC (145oF) or above for 15 seconds for: P
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(a) Raw EGGS that are broken and prepared in response to a 

CONSUMER'S order and for immediate service, P and

(b) Except as specified under Subparagraphs (A)(2) and (A)(3) and 

¶ (B), and in ¶ (C) of this section, FISH and INTACT MEAT including 

GAME ANIMALS commercially raised for FOOD as specified under 

Subparagraph 3-201.17(A)(1) and GAME ANIMALS under a voluntary 

inspection program as specified under Subparagraph 

3-201.17(A)(2); P

(2) 68oC (155oF) for 17 seconds or the temperature specified in the 

following chart that corresponds to the holding time for RATITES, and 

nonINTACT MEATS; the following if they are COMMINUTED: FISH and GAME 

ANIMALS commercially raised for FOOD as specified under Subparagraph 3-

201.17(A)(1), and GAME ANIMALS under a voluntary inspection program as 

specified under Subparagraph 3-201.17(A)(2); and raw EGGS that are not 

prepared as specified under Subparagraph (A)(1)(a) of this section: P

Minimum Temperature °C (°F) Minimum Time

63 (145) 3 minutes

66 (150) 1 minute

70 (158) < 1 second (instantaneous)

or

(3) 74oC (165oF) or above for < 1 second (instantaneous) for POULTRY, 

BALUTS, wild GAME ANIMALS as specified under Subparagraphs 

3-201.17(A)(3) and (4), stuffed FISH, stuffed MEAT, stuffed pasta, stuffed 

POULTRY, stuffed RATITES, or stuffing containing FISH, MEAT, POULTRY, or 

RATITES. P 

(B) Whole MEAT roasts including beef, corned beef, lamb, pork, and cured pork 

roasts such as ham shall be cooked:
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(1) As specified in the following chart, to heat all parts of the FOOD to a 

temperature and for the holding time that corresponds to that 

temperature: P 

Temperature °C (°F) Time1 in Minutes

54.4 (130) 112

55.0 (131) 89

56.1 (133) 56

57.2 (135) 36

57.8 (136) 28

58.9 (138) 18

60.0 (140) 12

61.1 (142) 8

62.2 (144) 5

62.8 (145) 4

1Holding time may include postoven heat rise. 

 

Temperature °C (°F) Time1 in Seconds

63.9 (147) 134

65.0 (149) 85

66.1 (151) 54

67.2 (153) 34

68.3 (155) 22

69.4 (157) 14

70.0 (158) 0

1Holding time may include postoven heat rise. 

and

(2) If cooked in an oven, use an oven that is preheated to the temperature 

specified for the roast's weight in the following chart and that is held at that 

temperature: Pf
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 Oven Temperature Based on Roast Weight

Oven Type Less than 4.5 kg (10 lbs) 4.5 kg (10 lbs) or More

Still Dry 177°C (350°F) or more 121°C (250°F) or more

Convection 163°C (325°F) or more 121°C (250°F) or more

High Humidity 1 121°C (250°F) or less 121°C (250°F) or less

1 Relative humidity greater than 90% for at least 1 hour as measured in the 

cooking chamber or exit of the oven; or in a moisture-impermeable bag 

that provides 100% humidity. 

(C) A raw or undercooked WHOLE-MUSCLE, INTACT BEEF steak may be served or 

offered for sale in a READY-TO-EAT form if:

(1) The food establishment serves a population that is not a highly 

susceptible population,

(2) The steak is prepared so that it remains intact, and

(3) The steak is cooked on both the top and bottom to a surface 

temperature of 63oC (145oF) or above and a cooked color change is 

achieved on all external surfaces.

(D) A raw animal FOOD such as raw EGG, raw FISH, raw-marinated FISH, raw 

MOLLUSCAN SHELLFISH, or steak tartare; or a partially cooked FOOD such as lightly 

cooked FISH, soft cooked EGGS, or rare MEAT other than WHOLE-MUSCLE, INTACT 

BEEF steaks as specified in ¶ (C) of this section, may be served or offered for sale 

upon CONSUMER request or selection in a READY-TO-EAT form if:

(1) As specified under ¶¶ 3-801.11(C)(1) and (2), the FOOD ESTABLISHMENT

serves a population that is not a HIGHLY SUSCEPTIBLE POPULATION;

(2) The FOOD, if served or offered for service by CONSUMER selection from 

a children’s menu, does not contain COMMINUTED MEAT; Pf and

(3) The CONSUMER is informed as specified under § 3-603.11 that to 

ensure its safety, the FOOD should be cooked as specified under ¶ (A) or 

(B) of this section; or

(4) The REGULATORY AUTHORITY grants a VARIANCE from ¶ (A) or (B) of this 

section as specified in § 8-103.10 based on a HACCP PLAN that:

(a) Is submitted by the permit holder and approved as specified 

under § 8-103.11,

(b) Documents scientific data or other information showing that a 

lesser time and temperature regimen results in a safe food, and
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(c) Verifies that equipment and procedures for food preparation and 

training of food employees at the food establishment meet the 

conditions of the VARIANCE. 

3-401.12 Microwave Cooking.

Raw animal FOODS cooked in a microwave oven shall be: 

(A) Rotated or stirred throughout or midway during cooking to compensate 

for uneven distribution of heat;

(B) Covered to retain surface moisture;

(C) Heated to a temperature of at least 74oC (165oF) in all parts of the 

FOOD;

P and

(D) Allowed to stand covered for 2 minutes after cooking to obtain 

temperature equilibrium.

3-401.13 Plant Food Cooking for Hot Holding.

Plant FOODS that are cooked for hot holding shall be cooked to a temperature of 

57oC (135oF). Pf 

3-401.14 Non-Continuous Cooking of Raw Animal Foods.

Raw animal FOODS that are cooked using a NON-CONTINUOUS COOKING process 

shall be:

(A) Subject to an initial heating process that is no longer than sixty 

minutes in duration; P

(B) Immediately after initial heating, cooled according to the time and 

temperature parameters specified for cooked TIME/TEMPERATURE CONTROL 

FOR SAFETY FOOD under ¶ 3-501.14(A); P

(C) After cooling, held frozen or cold, as specified for TIME/TEMPERATURE 

CONTROL FOR SAFETY FOOD under ¶ 3-501.16(A)(2); P

(D) Prior to sale or service, cooked using a process that heats all parts of 

the FOOD to a temperature and for a time as specified under ¶¶3-401.11 

(A)-(C); P

(E) Cooled according to the time and temperature parameters specified for 

cooked TIME /TEMPERATURE CONTROL FOR SAFETY FOOD under

¶ 3-501.14(A) if not either hot held as specified under ¶3-501.16(A), 

served immediately, or held using time as a public health control as 

specified under §3-501.19 after complete cooking; P and

(F) Prepared and stored according to written procedures that:

(1) Have obtained prior APPROVAL from the REGULATORY AUTHORITY; Pf

(2) Are maintained in the FOOD ESTABLISHMENT and are available to 

the REGULATORY AUTHORITY upon request; Pf
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(3) Describe how the requirements specified under ¶ (A)-(E) of this 

Section are to be monitored and documented by the PERMIT HOLDER 

and the corrective actions to be taken if the requirements are not 

met; Pf

(4) Describe how the FOODS, after initial heating, but prior to 

complete cooking, are to be marked or otherwise identified as 

FOODS that must be cooked as specified under ¶ (D) of this section 

prior to being offered for sale or service; Pf and

(5) Describe how the FOODS, after initial heating but prior to cooking 

as specified under ¶(D) of this section, are to be separated from 

READY-TO-EAT FOODS as specified under 

¶3-302.11 (A). Pf

3-401.15 Manufacturer Cooking Instructions.

(A) Commercially PACKAGED FOOD that bears a manufacturer’s cooking 

instructions shall be cooked according to those instructions before use in READYTO-EAT FOODS or offered in unPACKAGED form for human consumption, unless the 

manufacturer’s instructions specify that the FOOD may be consumed without 

cooking. P

(B) FOOD for which the manufacturer has provided information that it has not 

been processed to control pathogens, when used in READY-TO-EAT FOODS or 

offered for human consumption, shall be cooked according to a time and 

temperature appropriate for the FOOD. P

3-402 Freezing

3-402.11 Parasite Destruction.

(A) Except as specified in ¶ (B) of this section, before service or sale in READYTO-EAT form, raw, raw-marinated, partially cooked, or marinated-partially cooked 

FISH shall be:

(1) Frozen and stored at a temperature of -20°C (-4°F) or below for a 

minimum of 168 hours (7 days) in a freezer; P

(2) Frozen at -35°C (-31°F) or below until solid and stored at -35°C (-31°F) 

or below for a minimum of 15 hours; P or

(3) Frozen at -35°C (-31°F) or below until solid and stored at -20°C (-4°F) 

or below for a minimum of 24 hours. P 

(B) Paragraph (A) of this section does not apply to: 

(1) Molluscan shellfish;

(2) A scallop product consisting only of the shucked adductor muscle;

(3) Tuna of the species Thunnus alalunga, Thunnus albacares (Yellowfin 

tuna), Thunnus atlanticus, Thunnus maccoyii (Bluefin tuna, Southern), 
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Thunnus obesus (Bigeye tuna), or Thunnus thynnus (Bluefin tuna, 

Northern); or

(4) Aquacultured fish, such as salmon, that:

(a) If raised in open water, are raised in net-pens, or

(b) Are raised in land-based operations such as ponds or tanks, and

(c) Are fed formulated feed, such as pellets, that contains no live 

parasites infective to the aquacultured FISH.

(5) FISH eggs that have been removed from the skein and rinsed. 

3-402.12 Records, Creation and Retention.

(A) Except as specified in ¶ 3-402.11(B) and ¶ (B) of this section, if raw, rawmarinated, partially cooked, or marinated-partially cooked FISH are served or sold 

in READY-TO-EAT form, the PERSON IN CHARGE shall record the freezing 

temperature and time to which the FISH are subjected and shall retain the records 

of the FOOD ESTABLISHMENT for 90 calendar days beyond the time of service or 

sale of the FISH. Pf

(B) If the FISH are frozen by a supplier, a written agreement or statement from the 

supplier stipulating that the FISH supplied are frozen to a temperature and for a 

time specified under § 3-402.11 may substitute for the records specified under ¶ 

(A) of this section.

(C) If raw, raw-marinated, partially cooked, or marinated-partially cooked FISH are 

served or sold in READY-TO-EAT form, and the FISH are raised and fed as specified 

in Subparagraph 3-402.11(B)(4), a written agreement or statement from the 

supplier or aquaculturist stipulating that the FISH were raised and fed as specified 

in Subparagraph 3-402.11(B)(4) shall be obtained by the PERSON IN CHARGE and 

retained in the records of the FOOD ESTABLISHMENT for 90 calendar days beyond 

the time of service or sale of the FISH. Pf 

3-403 Reheating

3-403.10 Preparation for Immediate Service. 

Cooked and refrigerated FOOD that is prepared for immediate service in response 

to an individual CONSUMER order, such as a roast beef sandwich au jus, may be 

served at any temperature. 

3-403.11 Reheating for Hot Holding.

(A) Except as specified under ¶¶ (B) and (C) and in ¶ (E) of this section, 

TIME/TEMPERATURE CONTROL FOR SAFETY FOOD that is cooked, cooled, and reheated 

for hot holding shall be reheated so that all parts of the FOOD reach a temperature 

of at least 74oC (165oF) for 15 seconds. P
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(B) Except as specified under ¶ (C) of this section, TIME/TEMPERATURE CONTROL 

FOR SAFETY FOOD reheated in a microwave oven for hot holding shall be reheated 

so that all parts of the FOOD reach a temperature of at least 74oC (165oF) and the 

FOOD is rotated or stirred, covered, and allowed to stand covered for 2 minutes 

after reheating. P

(C) READY-TO-EAT TIME/TEMPERATURE CONTROL FOR SAFETY FOOD that has been 

commercially processed and PACKAGED in a FOOD PROCESSING PLANT that is 

inspected by the REGULATORY AUTHORITY that has jurisdiction over the plant, shall 

be heated to a temperature of at least 57oC (135oF) when being reheated for hot 

holding. P 

(D) Reheating for hot holding as specified under ¶¶ (A) - (C) of this section shall be 

done rapidly and the time the food is between 5oC (41oF) and the temperatures 

specified under ¶¶ (A) - (C) of this section may not exceed 2 hours. P 

(E) Remaining unsliced portions of MEAT roasts that are cooked as specified 

under ¶ 3-401.11(B) may be reheated for hot holding using the oven parameters 

and minimum time and temperature conditions specified under ¶ 3-401.11(B). 

3-404 Other Methods

3-404.11 Treating Juice.

Juice packaged in a food establishment shall be:

(A) Treated under a HACCP PLAN as specified in §8-201.14 to attain a 5-

log reduction, which is equal to a 99.999% reduction, of the most resistant 

microorganism of public health significance; P or

(B) Labeled, if not treated to yield a 5-log reduction of the most resistant 

microorganism of public health significance: Pf 

(1) As specified under § 3-602.11, Pf and

(2) As specified in 21 CFR 101.17(g) Food labeling, warning, notice, 

and safe handling statements, JUICES that have not been specifically 

processed to prevent, reduce, or eliminate the presence of 

pathogens with the following, “WARNING: This product has not 

been pasteurized and, therefore, may contain harmful bacteria that 

can cause serious illness in children, the elderly, and persons with 

weakened immune systems.” Pf

3-5 Limitation of Growth of Organisms of Public Health Concern

3-501 Temperature and Time Control

3-501.11 Frozen Food.

Stored frozen FOODS shall be maintained frozen.

3-501.12 Time/Temperature Control for Safety Food, Slacking.
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Frozen TIME/TEMPERATURE CONTROL FOR SAFETY FOOD that is slacked to moderate 

the temperature shall be held: 

(A) Under refrigeration that maintains the FOOD temperature at 5oC (41oF) 

or less; or

(B) At any temperature if the FOOD remains frozen. 

3-501.13 Thawing.

Except as specified in ¶ (D) of this section, TIME/TEMPERATURE CONTROL FOR 

SAFETY FOOD shall be thawed:

(A) Under refrigeration that maintains the FOOD temperature at 5oC (41oF) 

or less Pf; or 

(B) Completely submerged under running water: 

(1) At a water temperature of 21oC (70oF) or below Pf,

(2) With sufficient water velocity to agitate and float off loose 

particles in an overflow Pf, and

(3) For a period of time that does not allow thawed portions of 

READY-TO-EAT FOOD to rise above 5oC (41oF) Pf, or

(4) For a period of time that does not allow thawed portions of a raw 

animal FOOD requiring cooking as specified under ¶ 3-401.11(A) or 

(B) to be above 5oC (41oF), for more than 4 hours including: 

(a) The time the FOOD is exposed to the running water and 

the time needed for preparation for cooking Pf, or

(b) The time it takes under refrigeration to lower the FOOD

temperature to 5oC (41oF) Pf;

(C) As part of a cooking process if the FOOD that is frozen is: 

(1) Cooked as specified under ¶¶3-401.11(A) or (B), §3-401.12, or § 

3-401.15 Pf, or

(2) Thawed in a microwave oven and immediately transferred to 

conventional cooking EQUIPMENT, with no interruption in the process 

Pf; or

(D) Using any procedure if a portion of frozen READY-TO-EAT FOOD is 

thawed and prepared for immediate service in response to an individual 

CONSUMER'S order.

(E) REDUCED OXYGEN PACKAGED FISH that bears a label indicating that it is 

to be kept frozen until time of use shall be removed from the reduced 

oxygen environment:

(1) Prior to its thawing under refrigeration as specified in ¶(A) of this 

section; or
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(2) Prior to, or Immediately upon completion of, its thawing using 

procedures specified in ¶ (B) of this section.

3-501.14 Cooling.

(A) Cooked time/temperature control for safety food shall be cooled:

(1) Within 2 hours from 57oC (135oF) to 21oC (70°F); P and

(2) Within a total of 6 hours from 57oC (135oF) to 5oC (41°F) or less. P

(B) TIME/TEMPERATURE CONTROL FOR SAFETY FOOD shall be cooled within 4 hours 

to 5oC (41oF) or less if prepared from ingredients at ambient temperature, such 

as reconstituted FOODS and canned tuna. P 

(C) Except as specified under ¶ (D) of this section, a TIME/TEMPERATURE CONTROL 

FOR SAFETY FOOD received in compliance with LAWS allowing a temperature above 

5oC (41oF) during shipment from the supplier as specified in ¶ 3-202.11(B), shall 

be cooled within 4 hours to 5oC (41oF) or less. P

(D) Raw EGGS shall be received as specified under ¶ 3-202.11(C) and 

immediately placed in refrigerated EQUIPMENT that maintains an ambient air 

temperature of 7oC (45oF) or less. P

3-501.15 Cooling Methods.

(A) Cooling shall be accomplished in accordance with the time and temperature 

criteria specified under § 3-501.14 by using one or more of the following methods 

based on the type of FOOD being cooled:

(1) Placing the food in shallow pans; Pf

(2) Separating the food into smaller or thinner portions; Pf

(3) Using rapid cooling equipment; Pf

(4) Stirring the food in a container placed in an ice water bath; Pf

(5) Using containers that facilitate heat transfer; Pf

(6) Adding ice as an ingredient; Pf or

(7) Other effective methods. Pf 

(B) When placed in cooling or cold holding EQUIPMENT, FOOD containers in which 

FOOD is being cooled shall be: 

(1) Arranged in the EQUIPMENT to provide maximum heat transfer through 

the container walls; and
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(2) Loosely covered, or uncovered if protected from overhead 

contamination as specified under Subparagraph 3-305.11(A)(2), during 

the cooling period to facilitate heat transfer from the surface of the FOOD. 

3-501.16 Time/Temperature Control for Safety Food, Hot and Cold 

Holding.

(A) Except during preparation, cooking, or cooling, or when time is used as the 

public health control as specified under §3-501.19, and except as specified under 

¶ (B) and in ¶ (C) of this section, TIME/TEMPERATURE CONTROL FOR SAFETY FOOD

shall be maintained:

(1) At 57°C (135°F) or above, except that roasts cooked to a temperature 

and for a time specified in ¶ 3-401.11(B) or reheated as specified in ¶ 3-

403.11(E) may be held at a temperature of 54oC (130oF) or above; P or

(2) At 5°C (41°F) or less. P

(B) EGGS that have not been treated to destroy all viable Salmonellae shall be 

stored in refrigerated EQUIPMENT that maintains an ambient air temperature of 

7°C (45°F) or less. P 

(C) TIME/TEMPERATURE CONTROL FOR SAFETY FOOD in a homogenous liquid form 

may be maintained outside of the temperature control requirements, as specified 

under ¶ (A) of this section, while contained within specially designed EQUIPMENT

that complies with the design and construction requirements as specified under ¶ 

4-204.13(E).

On-premises preparation

Prepare and hold cold

3-501.17 Ready-to-Eat, Time/Temperature Control for Safety Food, Date 

Marking.

(A) Except when PACKAGING FOOD using a REDUCED OXYGEN PACKAGING method 

as specified under § 3-502.12, and except as specified in ¶¶ (E) and (F) of this 

section, refrigerated, READY-TO-EAT, TIME/TEMPERATURE CONTROL FOR SAFETY FOOD

prepared and held in a FOOD ESTABLISHMENT for more than 24 hours shall be 

clearly marked to indicate the date or day by which the FOOD shall be consumed 

on the PREMISES, sold, or discarded when held at a temperature of 5oC (41oF) or 

less for a maximum of 7 days. The day of preparation shall be counted as Day 1.

Pf

Commercially processed food

Open and hold cold

(B) Except as specified in ¶¶ (E) - (G) of this section, refrigerated, READY-TO-EAT 

TIME/TEMPERATURE CONTROL FOR SAFETY FOOD prepared and PACKAGED by a FOOD 

PROCESSING PLANT shall be clearly marked, at the time the original container is 

opened in a FOOD ESTABLISHMENT and if the FOOD is held for more than 24 hours, 

to indicate the date or day by which the FOOD shall be consumed on the 
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PREMISES, sold, or discarded, based on the temperature and time combinations 

specified in ¶ (A) of this section and: Pf

(1) The day the original container is opened in the FOOD ESTABLISHMENT

shall be counted as Day 1; Pf and

(2) The day or date marked by the FOOD ESTABLISHMENT may not exceed a 

manufacturer’s use-by date if the manufacturer determined the use-by 

date based on FOOD safety. Pf

(C) A refrigerated, READY-TO-EAT TIME/TEMPERATURE CONTROL FOR SAFETY FOOD

ingredient or a portion of a refrigerated, READY-TO-EAT, TIME/TEMPERATURE 

CONTROL FOR SAFETY FOOD that is subsequently combined with additional 

ingredients or portions of FOOD shall retain the date marking of the earliestprepared or first-prepared ingredient. Pf 

(D) A date marking system that meets the criteria stated in ¶¶ (A) and (B) of this 

section may include: 

(1) Using a method approved by the regulatory authority for refrigerated, 

ready-to-eat time/temperature control for safety food that is frequently 

rewrapped, such as lunchmeat or a roast, or for which date marking is 

impractical, such as soft serve mix or milk in a dispensing machine; 

(2) Marking the date or day of preparation, with a procedure to discard the 

food on or before the last date or day by which the food must be 

consumed on the premises, sold, or discarded as specified under ¶ (A) of 

this section; 

(3) Marking the date or day the original container is opened in a food 

establishment, with a procedure to discard the food on or before the last 

date or day by which the food must be consumed on the premises, sold, 

or discarded as specified under ¶ (B) of this section; or

(4) Using calendar dates, days of the week, color-coded marks, or other 

effective marking methods, provided that the marking system is disclosed 

to the REGULATORY AUTHORITY upon request.

(E) Paragraphs (A) and (B) of this section do not apply to individual meal portions 

served or rePACKAGED for sale from a bulk container upon a consumer’s request.

(F) Paragraphs (A) and (B) of this section do not apply to SHELLSTOCK.

(G) Paragraph (B) of this section does not apply to the following FOODS prepared 

and PACKAGED by a FOOD PROCESSING PLANT inspected by a REGULATORY 

AUTHORITY: 

(1) Deli salads, such as ham salad, seafood salad, chicken salad, egg 

salad, pasta salad, potato salad, and macaroni salad, manufactured in 

accordance with 21 CFR 117 Current good manufacturing practice in 

manufacturing, packing, or holding human food;
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(2) Hard cheeses containing not more than 39% moisture as defined in 21 

CFR 133 Cheeses and related cheese products, such as cheddar, 

gruyere, parmesan and reggiano, and romano;

(3) Semi-soft cheeses containing more than 39% moisture, but not more 

than 50% moisture, as defined in 21 CFR 133 Cheeses and related 

cheese products, such as blue, edam, gorgonzola, gouda, and monterey 

jack;

(4) Cultured dairy products as defined in 21 CFR 131 Milk and cream, 

such as yogurt, sour cream, and buttermilk;

(5) Preserved FISH products, such as pickled herring and dried or salted 

cod, and other acidified FISH products defined in 21 CFR 114 Acidified 

foods;

(6) Shelf stable, dry fermented sausages, such as pepperoni and Genoa; 

and

(7) Shelf stable salt-cured products such as prosciutto and Parma (ham).

3-501.18 Ready-to-Eat, Time/Temperature Control for Safety Food, 

Disposition.

(A) A FOOD specified in ¶ 3-501.17(A) or (B) shall be discarded if it:

(1) Exceeds the temperature and time combination specified in ¶ 3-

501.17(A), except time that the product is frozen; P

(2) Is in a container or PACKAGE that does not bear a date or day; P or

(3) Is inappropriately marked with a date or day that exceeds a 

temperature and time combination as specified in ¶ 3-501.17(A).P

(B) Refrigerated, READY-TO-EAT, TIME/TEMPERATURE CONTROL FOR SAFETY FOOD

prepared in a FOOD ESTABLISHMENT and dispensed through a VENDING MACHINE

with an automatic shutoff control shall be discarded if it exceeds a temperature 

and time combination as specified in ¶ 3-501.17(A). P

3-501.19 Time as a Public Health Control.

(A) Except as specified under ¶ (D) of this section, if time without temperature 

control is used as the public health control for a working supply of 

TIME/TEMPERATURE CONTROL FOR SAFETY FOOD before cooking, or for READY-TO-EAT

TIME/TEMPERATURE CONTROL FOR SAFETY FOOD that is displayed or held for sale or 

service: 

(1) Written procedures shall be prepared in advance, maintained in the 

FOOD ESTABLISHMENT and made available to the REGULATORY AUTHORITY

upon request that specify: Pf

(a) Methods of compliance with Subparagraphs (B)(1)-(4) or (C)(1)-

(5) of this section; Pf and
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(b) Methods of compliance with § 3-501.14 for FOOD that is 

prepared, cooked, and refrigerated before time is used as a public 

health control. Pf

Time – maximum up to 4 hours

(B) If time without temperature control is used as the public health control up to a 

maximum of 4 hours:

(1) Except as specified in (B)(2), the FOOD shall have an initial temperature 

of 5°C (41oF) or less when removed from cold holding temperature 

control, or 57°C (135°F) or greater when removed from hot holding 

temperature control; P

(2) The FOOD may have an initial temperature of 21°C (70°F) or less if;

(a) It is a ready-to-eat fruit or vegetable that upon cutting is 

rendered a time/temperature control for safety food as defined 

in ¶1-201.10(B), or

(b) It is a ready-to-eat hermetically sealed food that upon opening is 

rendered a time/temperature control for safety food a defined in ¶1-

201.10(B),

(c) The food temperature does not exceed 21°C (70°F) within a 

maximum time period of 4 hours from the time it was rendered a 

time/temperature control for safety food; and

(d) The food is marked or otherwise identified to indicate the time 

that is 4 hours past the point in time when the food is rendered a 

time/temperature control for safety food as specified in sub¶¶’ 

(B)(2)(a) and (b) of this section.

(3) The FOOD shall be marked or otherwise identified to indicate the time 

that is 4 hours past the point in time when the FOOD is removed from 

temperature control; Pf

(4) The FOOD shall be cooked and served, served at any temperature if 

READY-TO-EAT, or discarded, within 4 hours from the point in time when the 

FOOD is removed from temperature control; P and

(5) The FOOD in unmarked containers or PACKAGES, or marked to exceed a 

4-hour limit shall be discarded. P

Time – maximum up to 6 hours

(C) If time without temperature control is used as the public health control up to 

a maximum of 6 hours: 

(1) The FOOD shall have an initial temperature of 5oC (41oF) or less when 

removed from temperature control and the FOOD temperature may not 

exceed 21oC (70oF) within a maximum time period of 6 hours; P
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(2) The FOOD shall be monitored to ensure the warmest portion of the 

FOOD does not exceed 21oC (70oF) during the 6-hour period, unless an 

ambient air temperature is maintained that ensures the FOOD does not 

exceed 21oC (70oF) during the 6-hour holding period; Pf

(3) The FOOD shall be marked or otherwise identified to indicate: Pf

(a) The time when the FOOD is removed from 5oC (41oF) or less cold 

holding temperature control, Pf and

(b) The time that is 6 hours past the point in time when the FOOD is 

removed from cold holding temperature control; Pf

(4) The FOOD shall be:

(a) Discarded if the temperature of the food exceeds 21°C (70°F), P

or

(b) Cooked and served, served at any temperature if ready-to-eat, 

or discarded within a maximum of 6 hours from the point in time 

when the food is removed from 5oC (41oF) or less cold holding

temperature control; P and 

(5) The food in unmarked containers or packages, or marked with a time 

that exceeds the 6-hour limit shall be discarded.P

(D) A FOOD ESTABLISHMENT that serves a HIGHLY SUSCEPTIBLE POPULATION may not 

use time as specified under ¶¶ (A), (B) or (C) of this section as the public health 

control for raw EGGS.

3-502 Specialized Processing Methods

3-502.11 Variance Requirement. 

A FOOD ESTABLISHMENT shall obtain a VARIANCE from the REGULATORY AUTHORITY

as specified in § 8-103.10 and under § 8-103.11 before: Pf

(A) Smoking FOOD as a method of FOOD preservation rather than as a 

method of flavor enhancement; Pf

(B) Curing FOOD; Pf

(C) Using FOOD ADDITIVES or adding components such as vinegar: Pf 

(1) As a method of FOOD preservation rather than as a method of 

flavor enhancement, Pf or 

(2) To render a FOOD so that it is not TIME/TEMPERATURE CONTROL 

OF SAFETY FOOD; Pf

(D) Packaging TIME/TEMPERATURE CONTROL FOR SAFETY FOOD using a 

REDUCED OXYGEN PACKAGING method except where the growth of and toxin 

formation by Clostridium botulinum and the growth of Listeria 

monocytogenes are controlled as specified under § 3-502.12; Pf
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Chapter 3 - 33

(E) Operating a MOLLUSCAN SHELLFISH life-support system display tank 

used to store or display shellfish that are offered for human 

consumption;Pf

(F) Custom processing animals that are for personal use as FOOD and 

not for sale or service in a FOOD ESTABLISHMENT; Pf

(G) Preparing FOOD by another method that is determined by the 

REGULATORY AUTHORITY to require a VARIANCE; Pf or

(H) Sprouting seeds or beans. Pf 

Clostridium botulinum and Listeria monocytogenes Controls

3-502.12 Reduced Oxygen Packaging Without a Variance, Criteria.

(A) Except for a FOOD ESTABLISHMENT that obtains a VARIANCE as specified under 

§ 3-502.11, a FOOD ESTABLISHMENT that PACKAGES TIME/TEMPERATURE CONTROL 

FOR SAFETY FOOD using a REDUCED OXYGEN PACKAGING method shall control the 

growth and toxin formation of Clostridium botulinum and the growth of Listeria 

monocytogenes. P 

(B) Except as specified under ¶(F) of this section, a FOOD ESTABLISHMENT that 

PACKAGES TIME/TEMPERATURE CONTROL FOR SAFETY FOOD using a REDUCED OXYGEN 

PACKAGING method shall implement a HACCP PLAN that contains the information 

specified under ¶¶ 8-201.14 (C) and (D) and that: Pf

(1) Identifies the FOOD to be PACKAGED; Pf

(2) Except as specified under ¶¶ (C) - (E) of this section, requires that the 

PACKAGED FOOD shall be maintained at 5°C (41°F) or less and meet at 

least one of the following criteria: Pf

(a) Has an AW of 0.91 or less, Pf

(b) Has a PH of 4.6 or less, Pf

(c) (c) Is a MEAT or POULTRY product cured at a FOOD PROCESSING 

PLANT regulated by the USDA using substances specified in

9 CFR 424.21, Use of food ingredients and sources of radiation, 

and is received in an intact PACKAGE, Pf or

(d) (d) Is a FOOD with a high level of competing organisms such as 

raw MEAT, raw POULTRY, or raw vegetables; Pf

(3) Describes how the PACKAGE shall be prominently and conspicuously 

labeled on the principal display panel in bold type on a contrasting 

background, with instructions to: Pf 

(a) Maintain the FOOD at 5oC (41oF) or below, Pf and

(b) Discard the FOOD if within 30 calendar days of its PACKAGING if it 

is not served for on-PREMISES consumption, or consumed if served 

or sold for off-PREMISES consumption; Pf
FDA Food Code 2022 Chapter 3. Food

Chapter 3 - 34

(4) Limits the refrigerated shelf life to no more than 30 calendar days from 

PACKAGING to consumption, except the time the product is maintained 

frozen, or the original manufacturer’s “sell by” or “use by” date, whichever 

occurs first; P

(5) Includes operational procedures that: 

(a) Prohibit contacting READY-TO-EAT FOOD with bare hands as 

specified under ¶ 3-301.11(B), Pf

(b) Identify a designated work area and the method by which: Pf

(i) Physical barriers or methods of separation of raw FOODS

and READY-TO-EAT FOODS minimize cross contamination, Pf 

and

(ii) Access to the processing EQUIPMENT is limited to 

responsible trained personnel familiar with the potential 

HAZARDS of the operation, Pf and

(c) Delineate cleaning and SANITIZATION procedures for FOODCONTACT SURFACES; Pf and

(6) Describes the training program that ensures that the individual 

responsible for the REDUCED OXYGEN PACKAGING operation understands 

the: Pf 

(a) Concepts required for a safe operation, Pf

(b) EQUIPMENT and facilities, Pf and

(c) Procedures specified under Subparagraph (B)(5) of this section 

and ¶¶ 8-201.14 (C) and (D). Pf 

(7) Is provided to the REGULATORY AUTHORITY prior to implementation as 

specified under ¶ 8-201.13(B). 

Fish

(C) Except for FISH that is frozen before, during, and after PACKAGING and bears a 

label indicating that it is to be kept frozen until time of use, a FOOD ESTABLISHMENT

may not PACKAGE FISH using a REDUCED OXYGEN PACKAGING method. P 

Cook-Chill or Sous Vide

(D) Except as specified under ¶ (C) and ¶ (F) of this section, a FOOD 

ESTABLISHMENT that PACKAGES TIME/TEMPERATURE CONTROL FOR SAFETY FOOD using 

a cook-chill or sous vide process shall: 

(1) Provide to the REGULATORY AUTHORITY prior to implementation, a 

HACCP PLAN that contains the information as specified under ¶¶ 8-201.14 

(C) and (D); Pf

(2) Ensure the FOOD is:
FDA Food Code 2022 Chapter 3. Food

Chapter 3 - 35

(a) Prepared and consumed on the PREMISES, or prepared and 

consumed off the PREMISES but within the same business entity with 

no distribution or sale of the PACKAGED product to another business 

entity or the CONSUMER, Pf

(b) Cooked to heat all parts of the FOOD to a temperature and for a 

time as specified under ¶¶ 3-401.11 (A), (B), and (C), P

(c) Protected from contamination before and after cooking as 

specified under Parts 3-3 and 3-4, P

(d) Placed in a PACKAGE with an oxygen barrier and sealed before 

cooking, or placed in a PACKAGE and sealed immediately after 

cooking and before reaching a temperature below 57°C (135°F), P

(e) Cooled to 5°C (41°F) in the sealed PACKAGE or bag as specified 

under § 3-501.14 and: P

(i) Cooled to 1°C (34°F) within 48 hours of reaching 5°C 

(41°F) and held at that temperature until consumed or 

discarded within 30 days after the date of PACKAGING;

P

(ii) Held at 5°C (41°F) or less for no more than 7 days, at 

which time the FOOD must be consumed or discarded; P or

(iii) Cooled to 1°C (34°F) within 48 hours of reaching 5°C 

(41°F), removed from refrigeration equipment that maintains 

a 1°C (34°F) FOOD temperature and then held at 5°C (41°F) 

or less for no more than 7 days, not to exceed 30 days from 

its date of PACKAGING, at which time the FOOD must be 

consumed or discarded; P 

or

(iv) Held frozen with no shelf life restriction while frozen until 

consumed or used. P

(f) Held in a refrigeration unit that is equipped with an electronic 

system that continuously monitors time and temperature and is 

visually examined for proper operation twice daily, Pf

(g) If transported off-site to a satellite location of the same business 

entity, equipped with verifiable electronic monitoring devices to 

ensure that times and temperatures are monitored during 

transportation, Pf and

(h) Labeled with the product name and the date PACKAGED;

Pf and

(3) Maintain the records required to confirm that cooling and cold holding 

refrigeration time/temperature parameters are required as part of the 

HACCP PLAN and:

(a) Make such records available to the REGULATORY AUTHORITY upon 

request, Pf and
FDA Food Code 2022 Chapter 3. Food

Chapter 3 - 36

(b) Hold such records for at least 6 months; Pf and

(4) Implement written operational procedures as specified under

Subparagraph (B)(5) of this section and a training program as specified 

under Subparagraph (B)(6) of this section.Pf

Cheese

(E) Except as specified under ¶ (F) of this section, a FOOD ESTABLISHMENT that 

PACKAGES cheese using a REDUCED OXYGEN PACKAGING method shall:

(1) Limit the cheeses PACKAGED to those that are commercially 

manufactured in a FOOD PROCESSING PLANT with no ingredients added in 

the FOOD ESTABLISHMENT and that meet the Standards of Identity as 

specified in 21 CFR 133.150 Hard cheeses, 21 CFR 133.169 Pasteurized 

process cheese or 21 CFR 133.187 Semisoft cheeses; P

(2) Have a HACCP PLAN that contains the information specified under ¶¶ 

8-201.14 (C) and (D) and as specified under ¶¶ (B)(1), (B)(3)(a), (B)(5) 

and (B)(6) of this section; Pf

(3) Labels the PACKAGE on the principal display panel with a “use by” date 

that does not exceed 30 days from its packaging or the original 

manufacturer’s “sell by” or “use by” date, whichever occurs first; Pf and

(4) Discards the REDUCED OYGEN PACKAGED cheese if it is not sold for offPREMISES consumption or consumed within 30 calendar days of its 

PACKAGING. Pf 

(F) A HACCP Plan is not required when a food establishment uses a reduced 

oxygen packaging method to package time/temperature control for safety food 

that is always:

(1) Labeled with the production time and date,

(2) Held at 5°C (41°F) or less during refrigerated storage, and 

(3) Removed from its PACKAGE in the FOOD ESTABLISHMENT within 48 hours 

after PACKAGING.

3-6 Food Identity, Presentation, and On-Premises Labeling

3-601 Accurate Representation

3-601.11 Standards of Identity.

PACKAGED FOOD shall comply with standard of identity requirements in 21 CFR 

131-169 and 9 CFR 319 Definitions and standards of identity or composition, and 

the general requirements in 21 CFR 130 – Food Standards: General and 9 CFR 

319 Subpart A – General. 

3-601.12 Honestly Presented. 
FDA Food Code 2022 Chapter 3. Food

Chapter 3 - 37

(A) FOOD shall be offered for human consumption in a way that does not mislead 

or misinform the CONSUMER.

(B) FOOD or COLOR ADDITIVES, colored overwraps, or lights may not be used to 

misrepresent the true appearance, color, or quality of a FOOD.

3-602 Labeling

3-602.11 Food Labels. 

(A) FOOD PACKAGED in a FOOD ESTABLISHMENT, shall be labeled as specified in 

LAW, including 21 CFR 101 - Food labeling, and 9 CFR 317 Labeling, marking 

devices, and containers. 

(B) Label information shall include:

(1) The common name of the FOOD, or absent a common name, an 

adequately descriptive identity statement;

(2) If made from two or more ingredients, a list of ingredients and subingredients in descending order of predominance by weight, including a 

declaration of artificial colors, artificial flavors and chemical preservatives, 

if contained in the FOOD; 

(3) An accurate declaration of the net quantity of contents;

(4) The name and place of business of the manufacturer, packer, or 

distributor; and

(5) The name of the FOOD source for each MAJOR FOOD ALLERGEN

contained in the FOOD unless the FOOD source is already part of the 

common or usual name of the respective ingredient. Pf 

(6) Except as exempted in the Federal Food, Drug, and Cosmetic Act 

§ 403(q)(3) - (5), nutrition labeling as specified in 21 CFR 101 - Food 

Labeling and 9 CFR 317 Subpart B Nutrition Labeling. 

(7) For any salmonid FISH containing canthaxanthin or astaxanthin as a 

COLOR ADDITIVE, the labeling of the bulk FISH container, including a list of 

ingredients, displayed on the retail container or by other written means, 

such as a counter card, that discloses the use of canthaxanthin or 

astaxanthin.

(C) Bulk FOOD that is available for CONSUMER self-dispensing shall be prominently 

labeled with the following information in plain view of the CONSUMER: 

(1) The manufacturer's or processor's label that was provided with the 

FOOD; or

(2) A card, sign, or other method of notification that includes the 

information specified under Subparagraphs (B)(1), (2), (5) and (6) of this 

section. 

(D) Bulk, unPACKAGED FOODS such as bakery products and unPACKAGED FOODS

that are portioned to CONSUMER specification need not be labeled if: 
FDA Food Code 2022 Chapter 3. Food

Chapter 3 - 38

(1) A health, nutrient content, or other claim is not made;

(2) There are no state or local LAWS requiring labeling; and

(3) The FOOD is manufactured or prepared on the PREMISES of the FOOD 

ESTABLISHMENT or at another FOOD ESTABLISHMENT or a FOOD PROCESSING 

PLANT that is owned by the same PERSON and is regulated by the FOOD

regulatory agency that has jurisdiction. 

3-602.12 Other Forms of Information.

(A) If required by LAW, CONSUMER warnings shall be provided. 

(B) FOOD ESTABLISHMENT or manufacturers' dating information on FOODS may not 

be concealed or altered.

(C) The PERMIT HOLDER shall notify CONSUMERS by written notification of the 

presence of MAJOR FOOD ALLERGENS as an ingredient in unPACKAGED FOOD items 

that are served or sold to the CONSUMER.

3-603 Consumer Advisory

3-603.11 Consumption of Animal Foods that are Raw, Undercooked, or 

Not Otherwise Processed to Eliminate Pathogens.

(A) Except as specified in ¶ 3-401.11(C) and Subparagraph 3-401.11(D)(4) and

under ¶ 3-801.11(C), if an animal FOOD such as beef, EGGS, FISH, lamb, milk, 

pork, POULTRY, or shellfish is served or sold raw, undercooked, or without 

otherwise being processed to eliminate pathogens, either in READY-TO-EAT form 

or as an ingredient in another READY-TO-EAT FOOD, the PERMIT HOLDER shall inform 

CONSUMERS of the significantly increased RISK of consuming such FOODS by way 

of a DISCLOSURE and REMINDER, as specified in ¶¶ (B) and (C) of this section 

using brochures, deli case or menu advisories, label statements, table tents, 

placards, or other effective written means. Pf

(B) DISCLOSURE shall include: 

(1) A description of the animal-derived FOODS, such as “oysters on the half 

shell (raw oysters),” “raw-EGG Caesar salad,” and “hamburgers (can be 

cooked to order)”; Pf or

(2) Identification of the animal-derived FOODS by asterisking them to a 

footnote that states that the items are served raw or undercooked, or

contain (or may contain) raw or undercooked ingredients. Pf 

(C) REMINDER shall include asterisking the animal-derived FOODS requiring 

DISCLOSURE to a footnote that states:

(1) Regarding the safety of these items, written information is available 

upon request; Pf

(2) Consuming raw or undercooked MEATS, POULTRY, seafood, shellfish, or 

EGGS may increase your RISK of foodborne illness; Pf or
FDA Food Code 2022 Chapter 3. Food

Chapter 3 - 39

(3) Consuming raw or undercooked MEATS, POULTRY, seafood, shellfish, or 

EGGS may increase your RISK of foodborne illness, especially if you have 

certain medical conditions. Pf

3-7 Contaminated Food

3-307 Disposition

3-701.11 Discarding or Reconditioning Unsafe, Adulterated, or 

Contaminated Food.

(A) A FOOD that is unsafe, ADULTERATED, or not honestly presented as specified 

under § 3-101.11 shall be discarded or reconditioned according to an APPROVED

procedure. P 

(B) FOOD that is not from an APPROVED source as specified under §§ 3-201.11 -

.17 shall be discarded. P

(C) READY-TO-EAT FOOD that may have been contaminated by an EMPLOYEE who 

has been RESTRICTED or EXCLUDED as specified under § 2-201.12 shall be 

discarded. P

(D) FOOD that is contaminated by FOOD EMPLOYEES, CONSUMERS, or other 

PERSONS through contact with their hands, bodily discharges, such as nasal or 

oral discharges, or other means shall be discarded. P 

3-8 Special Requirements for Highly Susceptible Populations

3-801 Additional Safeguards

3-801.11 Pasteurized Foods, Prohibited Re-Service, and Prohibited Food.

In a food establishment that serves a highly susceptible population: 

(A) The following criteria apply to JUICE: 

(1) For the purposes of this paragraph only, children who are age 9 

or less and receive FOOD in a school, day care setting, or similar 

facility that provides custodial care are included as HIGHLY 

SUSCEPTIBLE POPULATIONS;

(2) PrePACKAGED JUICE or a prePACKAGED BEVERAGE containing 

JUICE, that bears a warning label as specified in 21 CFR, 101.17(g) 

Food labeling, warning, notice, and safe handling statements, 

Juices that have not been specifically processed to prevent, reduce, 

or eliminate the presence of pathogens, or a PACKAGED JUICE or 

BEVERAGE containing JUICE, that bears a warning label as specified 

under ¶ 3-404.11(B) may not be served or offered for sale; P and

(3) UnPACKAGED JUICE that is prepared on the premises for service 

or sale in a READY-TO-EAT form shall be processed under a HACCP

PLAN that contains the information specified under §8-201.14 (C) -

(E) and as specified in 21 CFR Part 120 – Hazard Analysis and 
FDA Food Code 2022 Chapter 3. Food

Chapter 3 - 40

Critical Control Point (HACCP) Systems, Subpart B Pathogen 

Reduction, 120.24 Process controls. P

(B) Pasteurized EGGS or EGG PRODUCTS shall be substituted for raw EGGS

in the preparation of: P 

(1) FOODS such as Caesar salad, hollandaise or Béarnaise sauce, 

mayonnaise, meringue, EGGnog, ice cream, and EGG-fortified 

BEVERAGES, P and

(2) Except as specified in ¶ (F) of this section, recipes in which more 

than one EGG is broken and the EGGS are combined; P

(C) The following FOODS may not be served or offered for sale in a READYTO-EAT form: P

(1) Raw animal FOODS such as raw FISH, raw-marinated FISH, raw 

MOLLUSCAN SHELLFISH, and steak tartare, P

(2) A partially cooked animal FOOD such as lightly cooked FISH, rare

MEAT, soft-cooked EGGS that are made from raw EGGS, and 

meringue; P and

(3) Raw seed sprouts. P

(4) PACKAGED FOOD as specified under § 3-401.15.

(D) FOOD EMPLOYEES may not contact READY-TO-EAT FOOD as specified

under ¶¶ 3-301.11(B) and (E). P

(E) Time only, as the public health control as specified under 

¶ 3-501.19(D), may not be used for raw EGGS. P 

(F) Subparagraph (B)(2) of this section does not apply if:

(1) The raw EGGS are combined immediately before cooking for one 

CONSUMER’S serving at a single meal, cooked as specified under 

Subparagraph 3-401.11(A)(1), and served immediately, such as an 

omelet, soufflé, or scrambled EGGS;

(2) The raw EGGS are combined as an ingredient immediately 

before baking and the EGGS are thoroughly cooked to a READY-TOEAT form, such as a cake, muffin, or bread; or 

(3) The preparation of the food is conducted under a HACCP PLAN

that: 

(a) Identifies the food to be prepared,

(b) Prohibits contacting ready-to-eat food with bare hands,

(c) Includes specifications and practices that ensure:

(i) Salmonella Enteritidis growth is controlled 

before and after cooking, and
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Chapter 3 - 41

(ii) Salmonella Enteritidis is destroyed by 

cooking the eggs according to the 

temperature and time specified in 

Subparagraph 3-401.11(A)(2),

(d) Contains the information specified under ¶ 8-201.14(D) 

including procedures that:

(i) Control cross contamination of ready-to-eat 

food with raw eggs, and 

(ii) Delineate cleaning and sanitization 

procedures for FOOD-CONTACT SURFACES, and

(e) Describes the training program that ensures that the food 

employee responsible for the preparation of the food understands 

the procedures to be used.

Re-service of food

(G) Except as specified in paragraph (H) of this section, FOOD may be reserved as specified under Subparagraph 3-306.14(B)(1) and (2).

Prohibited re-service of food

(H) Food may not be re-served under the following conditions: 

(1) Any FOOD served to patients or clients who are under contact 

precautions in medical isolation or quarantine, or protective 

environment isolation may not be re-served to others outside. 

(2) PACKAGES of FOOD from any patients, clients, or other 

CONSUMERS should not be re-served to PERSONS in protective 

environment isolation. 
FDA Food Code 2022 Chapter 4 Equipment, Utensils, and Linens

Chapter 4 - 1

Chapter 4 Equipment, 

Utensils, and Linens

Parts:

4-1 Materials for Construction and Repair

4-2 Design and Construction

4-3 Numbers and Capacities

4-4 Location and Installation

4-5 Maintenance and Operation

4-6 Cleaning of Equipment and Utensils

4-7 Sanitization of Equipment and Utensils

4-8 Laundering

4-9 Protection of Clean Items

4-1 Materials for Construction and Repair

4-101 Multiuse

4-101.11 Characteristics.

Materials that are used in the construction of UTENSILS and FOOD-CONTACT

SURFACES of EQUIPMENT may not allow the migration of deleterious substances or 

impart colors, odors, or tastes to FOOD and under normal use conditions shall be: P

(A) Safe; P

(B) Durable, CORROSION-RESISTANT, and nonabsorbent;

(C) Sufficient in weight and thickness to withstand repeated WAREWASHING;

(D) Finished to have a SMOOTH, EASILY CLEANABLE surface; and

(E) Resistant to pitting, chipping, crazing, scratching, scoring, distortion, 

and decomposition.

4-101.12 Cast Iron, Use Limitation.

(A) Except as specified in ¶¶ (B) and (C) of this section, cast iron may not 

be used for UTENSILS or FOOD-CONTACT SURFACES of EQUIPMENT.

(B) Cast iron may be used as a surface for cooking.

(C) Cast iron may be used in UTENSILS for serving FOOD if the UTENSILS are 

used only as part of an uninterrupted process from cooking through 

service. 
FDA Food Code 2022 Chapter 4 Equipment, Utensils, and Linens

Chapter 4 - 2

4-101.13 Lead, Use Limitation.

(A) Ceramic, china, and crystal UTENSILS, and decorative UTENSILS such as 

hand painted ceramic or china that are used in contact with FOOD shall be 

lead-free or contain levels of lead not exceeding the limits of the following 

UTENSIL categories: P

UTENSIL

Category

Ceramic Article 

Description

Maximum Lead

MG/L

Beverage Mugs, Cups, 

Pitchers

Coffee Mugs 0.5

Large Hollowware 

(excluding pitchers)

Bowls > 1.1 Liter

(1.16 Quart)

1

Small Hollowware 

(excluding cups & mugs)

Bowls < 1.1 Liter

(1.16 Quart)

2.0

Flat TABLEWARE Plates, Saucers 3.0

(B) Pewter alloys containing lead in excess of 0.05% may not be used as 

a FOOD-CONTACT SURFACE. P 

(C) Solder and flux containing lead in excess of 0.2% may not be used as 

a FOOD-CONTACT SURFACE. 

4-101.14 Copper, Use Limitation.

(A) Except as specified in ¶ (B) of this section, copper and copper alloys such as 

brass may not be used in contact with a FOOD that has a pH below 6 such as 

vinegar, fruit JUICE, or wine or for a fitting or tubing installed between a backflow 

prevention device and a carbonator. P 

(B) Copper and copper alloys may be used in contact with beer brewing 

ingredients that have a pH below 6 in the prefermentation and fermentation steps 

of a beer brewing operation such as a brewpub or microbrewery. 

4-101.15 Galvanized Metal, Use Limitation.

Galvanized metal may not be used for UTENSILS or FOOD-CONTACT SURFACES of 

EQUIPMENT that are used in contact with acidic FOOD. P

4-101.16 Sponges, Use Limitation.

Sponges may not be used in contact with cleaned and SANITIZED or in-use FOODCONTACT SURFACES. 

4-101.17 Wood, Use Limitation.
FDA Food Code 2022 Chapter 4 Equipment, Utensils, and Linens

Chapter 4 - 3

(A) Except as specified in ¶¶ (B), (C), and (D) of this section, wood and wood 

wicker may not be used as a FOOD-CONTACT SURFACE.

(B) Hard maple or an equivalently hard, close-grained wood may be used for: 

(1) Cutting boards; cutting blocks; bakers' tables; and UTENSILS such as 

rolling pins, doughnut dowels, salad bowls, and chopsticks; and

(2) Wooden paddles used in confectionery operations for pressure 

scraping kettles when manually preparing confections at a temperature of 

110oC (230oF) or above.

(C) Whole, uncut, raw fruits and vegetables, and nuts in the shell may be kept in 

the wood shipping containers in which they were received, until the fruits, 

vegetables, or nuts are used.

(D) If the nature of the FOOD requires removal of rinds, peels, husks, or shells 

before consumption, the whole, uncut, raw FOOD may be kept in: 

(1) Untreated wood containers; or

(2) Treated wood containers if the containers are treated with a 

preservative that meets the requirements specified in 21 CFR 178.3800 

Preservatives for wood.

4-101.18 Nonstick Coatings, Use Limitation. 

Multiuse KITCHENWARE such as frying pans, griddles, sauce pans, cookie sheets, 

and waffle bakers that have a perfluorocarbon resin coating shall be used with 

nonscoring or nonscratching UTENSILS and cleaning aids. 

4-101.19 Nonfood-Contact Surfaces. 

NonFOOD-CONTACT SURFACES of EQUIPMENT that are exposed to splash, spillage, 

or other FOOD soiling or that require frequent cleaning shall be constructed of a 

CORROSION-RESISTANT, nonabsorbent, and SMOOTH material. 

Single-Service and Single-Use

4-102.11 Characteristics. 

Materials that are used to make SINGLE-SERVICE and SINGLE-USE ARTICLES: 

(A) May not:

(1) Allow the migration of deleterious substances, P or

(2) Impart colors, odors, or tastes to FOOD; and

(B) Shall be:

(1) Safe, P and

(2) Clean.
FDA Food Code 2022 Chapter 4 Equipment, Utensils, and Linens

Chapter 4 - 4

4-2 Design and Construction

4-201 Durability and Strength

4-201.11 Equipment and Utensils. 

EQUIPMENT and UTENSILS shall be designed and constructed to be durable and to 

retain their characteristic qualities under normal use conditions. 

4-201.12 Food Temperature Measuring Devices.

FOOD TEMPERATURE MEASURING DEVICES may not have sensors or stems 

constructed of glass, except that thermometers with glass sensors or stems that 

are encased in a shatterproof coating such as candy thermometers may be used. P 

4-202 Cleanability

4-202.11 Food-Contact Surfaces.

(A) Multiuse FOOD-CONTACT SURFACES shall be:

(1) Smooth; Pf

(2) Free of breaks, open seams, cracks, chips, inclusions, pits, and similar 

imperfections; Pf

(3) Free of sharp internal angles, corners, and crevices; Pf

(4) Finished to have smooth welds and joints; Pf and

(5) Except as specified in ¶ (B) of this section, accessible for cleaning and 

inspection by one of the following methods:

(a) Without being disassembled, Pf

(b) By disassembling without the use of tools, Pf or

(c) By easy disassembling with the use of handheld tools commonly 

available to maintenance and cleaning personnel such as 

screwdrivers, pliers, open-end wrenches, and Allen wrenches. Pf 

(B) Subparagraph (A)(5) of this section does not apply to cooking oil 

storage tanks, distribution lines for cooking oils, or BEVERAGE syrup lines or 

tubes.

4-202.12 CIP Equipment. 

(A) CIP EQUIPMENT shall meet the characteristics specified under § 4-202.11 and 

shall be designed and constructed so that: 

(1) Cleaning and SANITIZING solutions circulate throughout a fixed system 

and contact all interior FOOD-CONTACT SURFACES, Pf and

(2) The system is self-draining or capable of being completely drained of 

cleaning and SANITIZING solutions; and
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(B) CIP EQUIPMENT that is not designed to be disassembled for cleaning shall be 

designed with inspection access points to ensure that all interior FOOD-CONTACT

SURFACES throughout the fixed system are being effectively cleaned. 

4-202.13 "V" Threads, Use Limitation.

Except for hot oil cooking or filtering EQUIPMENT, "V" type threads may not be 

used on FOOD-CONTACT SURFACES. 

4-202.14 Hot Oil Filtering Equipment. 

Hot oil filtering EQUIPMENT shall meet the characteristics specified under § 

4-202.11 or § 4-202.12 and shall be readily accessible for filter replacement and 

cleaning of the filter. 

4-202.15 Can Openers.

Cutting or piercing parts of can openers shall be readily removable for cleaning 

and for replacement. 

4-202.16 Nonfood-Contact Surfaces.

NonFOOD-CONTACT SURFACES shall be free of unnecessary ledges, projections, 

and crevices, and designed and constructed to allow easy cleaning and to 

facilitate maintenance.

4-202.17 Kick Plates, Removable.

Kick plates shall be designed so that the areas behind them are accessible for 

inspection and cleaning by being:

(A) Removable by one of the methods specified under Subparagraph 

4-202.11(A)(5) or capable of being rotated open; and

(B) Removable or capable of being rotated open without unlocking 

EQUIPMENT doors.

4-202.18 Ventilation Hood Systems, Filters.

Filters or other grease extracting EQUIPMENT shall be designed to be readily 

removable for cleaning and replacement if not designed to be cleaned in place. 

4-203 Accuracy

4-203.11 Temperature Measuring Devices, Food. 

(A) FOOD TEMPERATURE MEASURING DEVICES that are scaled only in Celsius or 

dually scaled in Celsius and Fahrenheit shall be accurate to ±1oC in the intended 

range of use. Pf 

(B) FOOD TEMPERATURE MEASURING DEVICES that are scaled only in Fahrenheit 

shall be accurate to ±2oF in the intended range of use. Pf

4-203.12 Temperature Measuring Devices, Ambient Air and Water. 
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(A) Ambient air and water TEMPERATURE MEASURING DEVICES that are scaled in 

Celsius or dually scaled in Celsius and Fahrenheit shall be designed to be easily 

readable and accurate to ±1.5oC in the intended range of use. Pf 

(B) Ambient air and water TEMPERATURE MEASURING DEVICES that are scaled only 

in Fahrenheit shall be accurate to ±3oF in the intended range of use. Pf 

4-203.13 Pressure Measuring Devices, Mechanical Warewashing 

Equipment. 

Pressure measuring devices that display the pressures in the water supply line 

for the fresh hot water SANITIZING rinse shall have increments of 7 kilopascals (1 

pound per square inch) or smaller and shall be accurate to ±14 kilopascals (±2 

pounds per square inch) in the range indicated on the manufacturer’s data plate.

4-204 Functionality

4-204.11 Ventilation Hood Systems, Drip Prevention. 

Exhaust ventilation hood systems in FOOD preparation and WAREWASHING areas 

including components such as hoods, fans, guards, and ducting shall be 

designed to prevent grease or condensation from draining or dripping onto FOOD, 

EQUIPMENT, UTENSILS, LINENS, and SINGLE-SERVICE and SINGLE-USE ARTICLES. 

4-204.12 Equipment Openings, Closures and Deflectors. 

(A) A cover or lid for EQUIPMENT shall overlap the opening and be sloped to drain. 

(B) An opening located within the top of a unit of EQUIPMENT that is designed for 

use with a cover or lid shall be flanged upward at least 5 millimeters (two-tenths 

of an inch).

(C) Except as specified under ¶ (D) of this section, fixed piping, TEMPERATURE 

MEASURING DEVICES, rotary shafts, and other parts extending into EQUIPMENT shall 

be provided with a watertight joint at the point where the item enters the 

EQUIPMENT.

(D) If a watertight joint is not provided: 

(1) The piping, TEMPERATURE MEASURING DEVICES, rotary shafts, and other 

parts extending through the openings shall be equipped with an apron 

designed to deflect condensation, drips, and dust from openings into the 

FOOD; and

(2) The opening shall be flanged as specified under ¶ (B) of this section. 

4-204.13 Dispensing Equipment, Protection of Equipment and Food. 

In EQUIPMENT that dispenses or vends liquid FOOD or ice in unPACKAGED form: 

(A) The delivery tube, chute, orifice, and splash surfaces directly above the 

container receiving the FOOD shall be designed in a manner, such as with 

barriers, baffles, or drip aprons, so that drips from condensation and splash are 

diverted from the opening of the container receiving the FOOD;
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(B) The delivery tube, chute, and orifice shall be protected from manual contact 

such as by being recessed;

(C) The delivery tube or chute and orifice of EQUIPMENT used to vend liquid FOOD

or ice in unPACKAGED form to self-service CONSUMERS shall be designed so that 

the delivery tube or chute and orifice are protected from dust, insects, rodents, 

and other contamination by a self-closing door if the EQUIPMENT is: 

(1) Located in an outside area that does not otherwise afford the 

protection of an enclosure against the rain, windblown debris, insects, 

rodents, and other contaminants that are present in the environment, or

(2) Available for self-service during hours when it is not under the full-time 

supervision of a FOOD EMPLOYEE; and

(D) The dispensing EQUIPMENT actuating lever or mechanism and filling device of 

CONSUMER self-service BEVERAGE dispensing EQUIPMENT shall be designed to 

prevent contact with the lip-contact surface of glasses or cups that are refilled.

(E) Dispensing EQUIPMENT in which TIME/TEMPERATURE CONTROL FOR SAFETY FOOD

in a homogenous liquid form is maintained outside of the temperature control 

requirements as specified under §3-501.16(A) shall:

(1) be specifically designed and equipped to maintain the commercial 

sterility of aseptically PACKAGED FOOD in a homogenous liquid form for a 

specified duration from the time of opening the PACKAGING within the 

EQUIPMENT; P and

(2) conform to the requirements for this EQUIPMENT as specified in 

NSF/ANSI 18-2006- Manual Food and Beverage Dispensing Equipment. P

4-204.14 Vending Machine, Vending Stage Closure.

The dispensing compartment of a VENDING MACHINE including a machine that is 

designed to vend prePACKAGED snack FOOD that is not TIME/TEMPERATURE 

CONTROL FOR SAFETY FOOD such as chips, party mixes, and pretzels shall be 

equipped with a self-closing door or cover if the machine is: 

(A) Located in an outside area that does not otherwise afford the 

protection of an enclosure against the rain, windblown debris, insects, 

rodents, and other contaminants that are present in the environment; or

(B) Available for self-service during hours when it is not under the full-time 

supervision of a FOOD EMPLOYEE.

4-204.15 Bearings and Gear Boxes, Leakproof. 

EQUIPMENT containing bearings and gears that require lubricants shall be 

designed and constructed so that the lubricant cannot leak, drip, or be forced into 

FOOD or onto FOOD-CONTACT SURFACES. 

4-204.16 Beverage Tubing, Separation.
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Except for cold plates that are constructed integrally with an ice storage bin, 

BEVERAGE tubing and cold-plate BEVERAGE cooling devices may not be installed in 

contact with stored ice. 

4-204.17 Ice Units, Separation of Drains. 

Liquid waste drain lines may not pass through an ice machine or ice storage bin.

4-204.18 Condenser Unit, Separation. 

If a condenser unit is an integral component of EQUIPMENT, the condenser unit 

shall be separated from the FOOD and FOOD storage space by a dustproof barrier. 

4-204.19 Can Openers on Vending Machines. 

Cutting or piercing parts of can openers on VENDING MACHINES shall be protected 

from manual contact, dust, insects, rodents, and other contamination.

4-204.110 Molluscan Shellfish Tanks.

(A) Except as specified under ¶ (B) of this section, MOLLUSCAN SHELLFISH life 

support system display tanks may not be used to store or display shellfish that 

are offered for human consumption and shall be conspicuously marked so that it 

is obvious to the CONSUMER that the shellfish are for display only.P 

(B) MOLLUSCAN SHELLFISH life-support system display tanks that are used to store 

or display shellfish that are offered for human consumption shall be operated and 

maintained in accordance with a VARIANCE granted by the REGULATORY AUTHORITY

as specified in § 8-103.10 and a HACCP PLAN that: Pf 

(1) Is submitted by the PERMIT HOLDER and APPROVED as specified under §

8-103.11; Pf and

(2) Ensures that:

(a) Water used with fish other than molluscan shellfish does not flow 

into the molluscan tank, Pf

(b) The safety and quality of the shellfish as they were received are 

not compromised by the use of the tank, Pf and

(c) The identity of the source of the shellstock is retained as 

specified under § 3-203.12. Pf

4-204.111 Vending Machines, Automatic Shutoff. 

(A) A machine vending TIME/TEMPERATURE CONTROL FOR SAFETY FOOD shall have 

an automatic control that prevents the machine from vending FOOD:

(1) If there is a power failure, mechanical failure, or other condition that 

results in an internal machine temperature that cannot maintain FOOD

temperatures as specified under Chapter 3; P and

(2) If a condition specified under Subparagraph (A)(1) of this section 

occurs, until the machine is serviced and restocked with FOOD that has 

been maintained at temperatures specified under Chapter 3. P
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(B) When the automatic shutoff within a machine vending TIME/TEMPERATURE 

CONTROL FOR SAFETY FOOD is activated: 

(1) In a refrigerated vending machine, the ambient air temperature may 

not exceed 5oC (41oF) for more than 30 minutes immediately after the 

machine is filled, serviced, or restocked; P or

(2) In a hot holding vending machine, the ambient air temperature may not 

be less than 57 oC (135 oF) for more than 120 minutes immediately after 

the machine is filled, serviced, or restocked. P 

4-204.112 Temperature Measuring Devices. 

(A) In a mechanically refrigerated or hot FOOD storage unit, the sensor of a 

TEMPERATURE MEASURING DEVICE shall be located to measure the air temperature 

or a simulated product temperature in the warmest part of a mechanically 

refrigerated unit and in the coolest part of a hot FOOD storage unit.

(B) Except as specified in ¶ (C) of this section, cold or hot holding EQUIPMENT

used for TIME/TEMPERATURE CONTROL FOR SAFETY FOOD shall be designed to 

include and shall be equipped with at least one integral or permanently affixed 

TEMPERATURE MEASURING DEVICE that is located to allow easy viewing of the 

device's temperature display. 

(C) Paragraph (B) of this section does not apply to EQUIPMENT for which the 

placement of a TEMPERATURE MEASURING DEVICE is not a practical means for 

measuring the ambient air surrounding the FOOD because of the design, type, 

and use of the EQUIPMENT, such as calrod units, heat lamps, cold plates, 

bainmaries, steam tables, insulated FOOD transport containers, and salad bars.

(D) TEMPERATURE MEASURING DEVICES shall be designed to be easily readable.

(E) FOOD TEMPERATURE MEASURING DEVICES and water TEMPERATURE MEASURING 

DEVICES on WAREWASHING machines shall have a numerical scale, printed record, 

or digital readout in increments no greater than 1oC or 2oF in the intended range 

of use. Pf 

4-204.113 Warewashing Machine, Data Plate Operating Specifications. 

A WAREWASHING machine shall be provided with an easily accessible and 

readable data plate affixed to the machine by the manufacturer that indicates the 

machine’s design and operation specifications including the: 

(A) Temperatures required for washing, rinsing, and SANITIZING;

(B) Pressure required for the fresh water SANITIZING rinse unless the 

machine is designed to use only a pumped SANITIZING rinse; and

(C) Conveyor speed for conveyor machines or cycle time for stationary 

rack machines.
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4-204.114 Warewashing Machines, Internal Baffles. 

WAREWASHING machine wash and rinse tanks shall be equipped with baffles, 

curtains, or other means to minimize internal cross contamination of the solutions 

in wash and rinse tanks. 

4-204.115 Warewashing Machines, Temperature Measuring Devices. 

A WAREWASHING machine shall be equipped with a TEMPERATURE MEASURING 

DEVICE that indicates the temperature of the water:

(A) In each wash and rinse tank; Pf and

(B) As the water enters the hot water SANITIZING final rinse manifold or in 

the chemical SANITIZING solution tank. Pf 

4-204.116 Manual Warewashing Equipment, Heaters and Baskets. 

If hot water is used for SANITIZATION in manual WAREWASHING operations, the 

SANITIZING compartment of the sink shall be:

(A) Designed with an integral heating device that is capable of maintaining 

water at a temperature not less than 77oC (171oF); Pf and

(B) Provided with a rack or basket to allow complete immersion of 

equipment and utensils into the hot water. Pf 

4-204.117 Warewashing Machines, Automatic Dispensing of Detergents 

and Sanitizers.

A WAREWASHING machine that is installed after adoption of this Code by the 

REGULATORY AUTHORITY, shall be equipped to: 

(A) Automatically dispense detergents and SANITIZERS; Pf and

(B) Incorporate a visual means to verify that detergents and SANITIZERS are 

delivered or a visual or audible alarm to signal if the detergents and 

SANITIZERS are not delivered to the respective washing and SANITIZING

cycles. Pf 

4-204.118 Warewashing Machines, Flow Pressure Device. 

(A) WAREWASHING machines that provide a fresh hot water SANITIZING rinse shall 

be equipped with a pressure gauge or similar device such as a transducer that 

measures and displays the water pressure in the supply line immediately before 

entering the WAREWASHING machine; and

(B) If the flow pressure measuring device is upstream of the fresh hot water 

SANITIZING rinse control valve, the device shall be mounted in a 6.4 millimeter or 

one-fourth inch Iron Pipe Size (IPS) valve.

(C) Paragraphs (A) and (B) of this section do not apply to a machine that uses 

only a pumped or recirculated SANITIZING rinse.
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4-204.119 Warewashing Sinks and Drainboards, Self-Draining. 

Sinks and drainboards of WAREWASHING sinks and machines shall be selfdraining. 

4-204.120 Equipment Compartments, Drainage. 

EQUIPMENT compartments that are subject to accumulation of moisture due to 

conditions such as condensation, FOOD or BEVERAGE drip, or water from melting 

ice shall be sloped to an outlet that allows complete draining. 

4-204.121 Vending Machines, Liquid Waste Products. 

(A) VENDING MACHINES designed to store BEVERAGES that are PACKAGED in 

containers made from paper products shall be equipped with diversion devices 

and retention pans or drains for container leakage.

(B) VENDING MACHINES that dispense liquid FOOD in bulk shall be: 

(1) Provided with an internally mounted waste receptacle for the collection 

of drip, spillage, overflow, or other internal wastes; and

(2) Equipped with an automatic shutoff device that will place the machine 

out of operation before the waste receptacle overflows.

(C) Shutoff devices specified under Subparagraph (B)(2) of this section shall 

prevent water or liquid FOOD from continuously running if there is a failure of a 

flow control device in the water or liquid FOOD system or waste accumulation that 

could lead to overflow of the waste receptacle.

4-204.122 Case Lot Handling Apparatuses, Moveability. 

Apparatuses, such as dollies, pallets, racks, and skids used to store and 

transport large quantities of PACKAGED FOODS received from a supplier in a cased 

or overwrapped lot, shall be designed to be moved by hand or by conveniently 

available apparatuses such as hand trucks and forklifts. 

4-204.123 Vending Machine Doors and Openings. 

(A) VENDING MACHINE doors and access opening covers to FOOD and container 

storage spaces shall be tight-fitting so that the space along the entire interface 

between the doors or covers and the cabinet of the machine, if the doors or 

covers are in a closed position, is no greater than 1.5 millimeters or one-sixteenth 

inch by: 

(1) Being covered with louvers, screens, or materials that provide an 

equivalent opening of not greater than 1.5 millimeters or one-sixteenth 

inch. Screening of 12 or more mesh to 2.5 centimeters (12 mesh to 1 

inch) meets this requirement;

(2) Being effectively gasketed;

(3) Having interface surfaces that are at least 13 millimeters or one-half 

inch wide; or
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(4) Jambs or surfaces used to form an L-shaped entry path to the 

interface. 

(B) VENDING MACHINE service connection openings through an exterior wall of a 

machine shall be closed by sealants, clamps, or grommets so that the openings 

are no larger than 1.5 millimeters or one-sixteenth inch. 

4-205 Acceptability

4-205.10 Food Equipment, Certification and Classification. 

FOOD EQUIPMENT that is certified or classified for sanitation in conformance to a 

recognized American National Standard by an American National Standards 

Institute (ANSI)-accredited certification program is deemed to comply with Parts 

4-1 and 4-2 of this chapter. 

4-3 Numbers and Capacities

4-301 Equipment

4-301.11 Cooling, Heating, and Holding Capacities. 

EQUIPMENT for cooling and heating FOOD, and holding cold and hot FOOD, shall be 

sufficient in number and capacity to provide FOOD temperatures as specified 

under Chapter 3. Pf 

4-301.12 Manual Warewashing, Sink Compartment Requirements. 

(A) Except as specified in ¶ (C) of this section, a sink with at least 

3 compartments shall be provided for manually washing, rinsing, and SANITIZING

EQUIPMENT and UTENSILS. Pf 

(B) Sink compartments shall be large enough to accommodate immersion of the 

largest EQUIPMENT and UTENSILS. If EQUIPMENT or UTENSILS are too large for the 

WAREWASHING sink, a WAREWASHING machine or alternative EQUIPMENT as 

specified in ¶ (C) of this section shall be used. Pf 

(C) Alternative manual WAREWASHING EQUIPMENT may be used when there are 

special cleaning needs or constraints and its use is APPROVED. Alternative 

manual WAREWASHING EQUIPMENT may include: 

(1) High-pressure detergent sprayers;

(2) Low- or line-pressure spray detergent foamers;

(3) Other task-specific cleaning EQUIPMENT;

(4) Brushes or other implements;

(5) 2-compartment sinks as specified under ¶¶ (D) and (E) of this section; 

or

(6) Receptacles that substitute for the compartments of a 

multicompartment sink. 
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(D) Before a 2-compartment sink is used: 

(1) The PERMIT HOLDER shall have its use APPROVED; and

(2) The PERMIT HOLDER shall limit the number of KITCHENWARE items 

cleaned and SANITIZED in the 2-compartment sink, and shall limit 

WAREWASHING to batch operations for cleaning KITCHENWARE such as 

between cutting one type of raw MEAT and another or cleanup at the end of 

a shift, and shall: 

(a) Make up the cleaning and SANITIZING solutions immediately 

before use and drain them immediately after use, and

(b) Use a detergent-SANITIZER to SANITIZE and apply the detergentSANITIZER in accordance with the manufacturer’s label instructions 

and as specified under § 4-501.115, or

(c) Use a hot water SANITIZATION immersion step as specified under 

¶ 4-603.16(C). 

(E) A 2-compartment sink may not be used for WAREWASHING operations where 

cleaning and SANITIZING solutions are used for a continuous or intermittent flow of 

KITCHENWARE or TABLEWARE in an ongoing WAREWASHING process. 

4-301.13 Drainboards. 

Drainboards, UTENSIL racks, or tables large enough to accommodate all soiled 

and cleaned items that may accumulate during hours of operation shall be 

provided for necessary UTENSIL holding before cleaning and after SANITIZING. 

4-301.14 Ventilation Hood Systems, Adequacy. 

Ventilation hood systems and devices shall be sufficient in number and capacity 

to prevent grease or condensation from collecting on walls and ceilings. 

4-301.15 Clothes Washers and Dryers. 

(A) Except as specified in ¶ (B) of this section, if work clothes or LINENS are 

laundered on the PREMISES, a mechanical clothes washer and dryer shall be 

provided and used. 

(B) If on-PREMISES laundering is limited to wiping cloths intended to be used 

moist, or wiping cloths are air-dried as specified under § 4-901.12, a mechanical 

clothes washer and dryer need not be provided. 

4-302 Utensils, Temperature Measuring Devices, and Testing Devices

4-302.11 Utensils, Consumer Self-Service. 

A FOOD dispensing UTENSIL shall be available for each container displayed at a 

CONSUMER self-service unit such as a buffet or salad bar. Pf 
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4-302.12 Food Temperature Measuring Devices. 

(A) FOOD TEMPERATURE MEASURING DEVICES shall be provided and readily 

accessible for use in ensuring attainment and maintenance of FOOD temperatures 

as specified under Chapter 3. Pf

(B) A TEMPERATURE MEASURING DEVICE with a suitable small-diameter probe that is 

designed to measure the temperature of thin masses shall be provided and 

readily accessible to accurately measure the temperature in thin FOODS such as 

MEAT patties and FISH filets. Pf 

4-302.13 Temperature Measuring Devices, Manual and Mechanical

Warewashing. 

(A) In manual WAREWASHING operations, a TEMPERATURE MEASURING DEVICE shall 

be provided and readily accessible for frequently measuring the washing and 

SANITIZING temperatures. Pf

(B) In hot water mechanical WAREWASHING operations, an irreversible registering 

temperature indicator shall be provided and readily accessible for measuring the

UTENSIL surface temperature.Pf 

4-302.14 Sanitizing Solutions, Testing Devices. 

A test kit or other device that accurately measures the concentration in MG/L of 

SANITIZING solutions shall be provided.Pf

4-303 Cleaning Agents and Sanitizers

4-303.11 Cleaning Agents and Sanitizers, Availability 

(A) Cleaning agents that are used to clean EQUIPMENT and UTENSILS as specified 

under Part 4-6, shall be provided and available for use during all hours of 

operation. Pf

(B) Except for those that are generated on-site at the time of use, chemical 

SANITIZERS that are used to sanitize EQUIPMENT and UTENSILS as specified under 

Part 4-7, shall be provided and available for use during all hours of operation. Pf

4-4 Location and Installation

4-401 Location

4-401.11 Equipment, Clothes Washers and Dryers, and Storage Cabinets, 

Contamination Prevention. 

(A) Except as specified in ¶ (B) of this section, EQUIPMENT, a cabinet used for the 

storage of FOOD, or a cabinet that is used to store cleaned and SANITIZED

EQUIPMENT, UTENSILS, laundered LINENS, and SINGLE-SERVICE and SINGLE-USE

ARTICLES may not be located: 

(1) In locker rooms;

(2) In toilet rooms; Pf
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(3) In garbage rooms;

(4) In mechanical rooms;

(5) Under sewer lines that are not shielded to intercept potential drips;

(6) Under leaking water lines including leaking automatic fire sprinkler 

heads or under lines on which water has condensed;

(7) Under open stairwells; or

(8) Under other sources of contamination. 

(B) A storage cabinet used for LINENS or SINGLE-SERVICE or SINGLE-USE ARTICLES

may be stored in a locker room. 

(C) If a mechanical clothes washer or dryer is provided, it shall be located so that 

the washer or dryer is protected from contamination and only where there is no 

exposed FOOD; clean EQUIPMENT, UTENSILS, and LINENS; and unwrapped SINGLESERVICE and SINGLE-USE ARTICLES.

4-402 Installation

4-402.11 Fixed Equipment, Spacing or Sealing.

(A) EQUIPMENT that is fixed because it is not EASILY MOVABLE shall be installed so 

that it is: 

(1) Spaced to allow access for cleaning along the sides, behind, and 

above the EQUIPMENT;

(2) Spaced from adjoining EQUIPMENT, walls, and ceilings a distance of not 

more than 1 millimeter or one thirty-second inch; or

(3) SEALED to adjoining EQUIPMENT or walls, if the EQUIPMENT is exposed to 

spillage or seepage.

(B) COUNTER-MOUNTED EQUIPMENT that is not EASILY MOVABLE shall be installed to 

allow cleaning of the EQUIPMENT and areas underneath and around the 

EQUIPMENT by being: 

(1) SEALED; or

(2) Elevated on legs as specified under ¶ 4-402.12(D).

4-402.12 Fixed Equipment, Elevation or Sealing. 

(A) Except as specified in ¶¶ (B) and (C) of this section, floor-mounted EQUIPMENT

that is not EASILY MOVABLE shall be SEALED to the floor or elevated on legs that 

provide at least a 15 centimeter (6 inch) clearance between the floor and the 

EQUIPMENT.

(B) If no part of the floor under the floor-mounted EQUIPMENT is more than 15 

centimeters (6 inches) from the point of cleaning access, the clearance space 

may be only 10 centimeters (4 inches).
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(C) This section does not apply to display shelving units, display refrigeration 

units, and display freezer units located in the CONSUMER shopping areas of a 

retail FOOD store, if the floor under the units is maintained clean.

(D) Except as specified in ¶ (E) of this section, COUNTER-MOUNTED EQUIPMENT that 

is not EASILY MOVABLE shall be elevated on legs that provide at least a 10 

centimeter (4 inch) clearance between the table and the EQUIPMENT.

(E) The clearance space between the table and COUNTER-MOUNTED EQUIPMENT

may be:

(1) 7.5 centimeters (3 inches) if the horizontal distance of the table top 

under the EQUIPMENT is no more than 50 centimeters (20 inches) from the 

point of access for cleaning; or

(2) 5 centimeters (2 inches) if the horizontal distance of the table top under 

the EQUIPMENT is no more than 7.5 centimeters (3 inches) from the point of 

access for cleaning.

4-5 Maintenance and Operation

4-501 Equipment

4-501.11 Good Repair and Proper Adjustment. 

(A) EQUIPMENT shall be maintained in a state of repair and condition that meets 

the requirements specified under Parts 4-1 and 4-2. 

(B) EQUIPMENT components such as doors, seals, hinges, fasteners, and kick 

plates shall be kept intact, tight, and adjusted in accordance with manufacturer's 

specifications. 

(C) Cutting or piercing parts of can openers shall be kept sharp to minimize the 

creation of metal fragments that can contaminate FOOD when the container is 

opened.

4-501.12 Cutting Surfaces. 

Surfaces such as cutting blocks and boards that are subject to scratching and 

scoring shall be resurfaced if they can no longer be effectively cleaned and 

SANITIZED, or discarded if they are not capable of being resurfaced. 

4-501.13 Microwave Ovens.

Microwave ovens shall meet the safety standards specified in 21 CFR 1030.10 

Microwave ovens. 

4-501.14 Warewashing Equipment, Cleaning Frequency. 

A WAREWASHING machine; the compartments of sinks, basins, or other 

receptacles used for washing and rinsing EQUIPMENT, UTENSILS, or raw FOODS, or 

laundering wiping cloths; and drainboards or other EQUIPMENT used to substitute 

for drainboards as specified under § 4-301.13 shall be cleaned: 

(A) Before use;
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(B) Throughout the day at a frequency necessary to prevent 

recontamination of EQUIPMENT and UTENSILS and to ensure that the 

EQUIPMENT performs its intended function; and

(C) If used, at least every 24 hours.

4-501.15 Warewashing Machines, Manufacturers' Operating Instructions. 

(A) A WAREWASHING machine and its auxiliary components shall be operated in 

accordance with the machine's data plate and other manufacturer's instructions.

(B) A WAREWASHING machine's conveyor speed or automatic cycle times shall be 

maintained accurately timed in accordance with manufacturer's specifications.

4-501.16 Warewashing Sinks, Use Limitation. 

(A) A WAREWASHING sink may not be used for handwashing as specified under § 

2-301.15.

(B) If a WAREWASHING sink is used to wash wiping cloths, wash produce, or thaw 

FOOD, the sink shall be cleaned as specified under § 4-501.14 before and after 

each time it is used to wash wiping cloths or wash produce or thaw FOOD. Sinks 

used to wash or thaw FOOD shall be SANITIZED as specified under Part 4-7 before 

and after using the sink to wash produce or thaw FOOD. 

4-501.17 Warewashing Equipment, Cleaning Agents. 

When used for WAREWASHING, the wash compartment of a sink, mechanical 

warewasher, or wash receptacle of alternative manual WAREWASHING EQUIPMENT

as specified in ¶ 4-301.12(C), shall contain a wash solution of soap, detergent, 

acid cleaner, alkaline cleaner, degreaser, abrasive cleaner, or other cleaning 

agent according to the cleaning agent manufacturer's label instructions. Pf

4-501.18 Warewashing Equipment, Clean Solutions. 

The wash, rinse, and SANITIZE solutions shall be maintained clean. 

4-501.19 Manual Warewashing Equipment, Wash Solution Temperature. 

The temperature of the wash solution in manual WAREWASHING EQUIPMENT shall 

be maintained at not less than 43oC (110oF) or the temperature specified on the 

cleaning agent manufacturer's label instructions. Pf

4-501.110 Mechanical Warewashing Equipment, Wash Solution 

Temperature. 

(A) The temperature of the wash solution in spray type warewashers that use hot 

water to SANITIZE may not be less than:

(1) For a stationary rack, single temperature machine, 74oC (165oF); Pf

(2) For a stationary rack, dual temperature machine, 66oC (150oF); Pf

(3) For a single tank, conveyor, dual temperature machine, 71oC (160oF);

Pf or

(4) For a multitank, conveyor, multitemperature machine, 66oC (150oF). Pf 
FDA Food Code 2022 Chapter 4 Equipment, Utensils, and Linens

Chapter 4 - 18

(B) The temperature of the wash solution in spray-type warewashers that use 

chemicals to SANITIZE may not be less than 49oC (120oF). Pf 

4-501.111 Manual Warewashing Equipment, Hot Water Sanitization 

Temperatures. 

If immersion in hot water is used for SANITIZING in a manual operation, the 

temperature of the water shall be maintained at 77oC (171oF) or above. P 

4-501.112 Mechanical Warewashing Equipment, Hot Water Sanitization 

Temperatures.

(A) Except as specified in ¶ (B) of this section, in a mechanical operation, the 

temperature of the fresh hot water SANITIZING rinse as it enters the manifold may 

not be more than 90oC (194oF), or less than: Pf

(1) For a stationary rack, single temperature machine, 74oC (165oF); Pf or

(2) For all other machines, 82oC (180oF). Pf 

(B) The maximum temperature specified under ¶ (A) of this section, does not 

apply to the high pressure and temperature systems with wand-type, hand-held, 

spraying devices used for the in-place cleaning and SANITIZING of EQUIPMENT such 

as meat saws. 

4-501.113 Mechanical Warewashing Equipment, Sanitization Pressure.

The flow pressure of the fresh hot water SANITIZING rinse in a WAREWASHING

machine, as measured in the water line immediately downstream or upstream 

from the fresh hot water SANITIZING rinse control value, shall be within the 

range specified on the machine manufacturer’s data plate and may not be less 

than 35 kilopascals (5 pounds per square inch) or more than 200 kilopascals (30 

pounds per square inch). 

4-501.114 Manual and Mechanical Warewashing Equipment, Chemical 

Sanitization - Temperature, pH, Concentration, and Hardness.

A chemical SANITIZER used in a SANITIZING solution for a manual or mechanical 

operation at contact times specified under ¶4-703.11(C) shall meet the criteria 

specified under §7-204.11 Sanitizers, Criteria, shall be used in accordance with 

the EPA-registered label use instructions, P and shall be used as follows:

(A) A chlorine solution shall have a minimum temperature based on the 

concentration and PH of the solution as listed in the following chart; P
FDA Food Code 2022 Chapter 4 Equipment, Utensils, and Linens

Chapter 4 - 19

CONCENTRATION 

RANGE

(MG/L)

MINIMUM TEMPERATURE 

PH 10 OR LESS

°C (°F)

MINIMUM TEMPERATURE 

PH 8 OR LESS

°C (°F)

25 – 49 49 (120) 49 (120)

50 – 99 38 (100) 24 (75)

100 13 (55) 13 (55)

(B) An iodine solution shall have a:

(1) Minimum temperature of 20°C (68°F), P

(2) PH of 5.0 or less or a PH no higher than the level for which the 

manufacturer specifies the solution is effective, P and

(3) Concentration between 12.5 MG/L and 25 MG/L; P

(C) A quaternary ammonium compound solution shall: 

(1) Have a minimum temperature of 24oC (75oF), P

(2) Have a concentration as specified under § 7-204.11 and as indicated 

by the manufacturer's use directions included in the labeling, P and

(3) Be used only in water with 500 MG/L hardness or less or in water 

having a hardness no greater than specified by the EPA-registered label 

use instructions; P

(D) If another solution of a chemical specified under ¶¶ (A) - (C) of this section is 

used, the PERMIT HOLDER shall demonstrate to the REGULATORY AUTHORITY that the 

solution achieves SANITIZATION and the use of the solution shall be APPROVED;

P

(E) If a chemical SANITIZER other than chlorine, iodine, or a quaternary ammonium 

compound is used, it shall be applied in accordance with the EPA-registered 

label use instructions; P and

(F) If a chemical SANITIZER is generated by a device located on-site at the FOOD 

ESTABLISHMENT it shall be used as specified in ¶¶(A) - (D) of this section and shall 

be produced by a device that:

(1) Complies with regulation as specified in §§ 2(q)(1) and 12 of the 

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA),P

(2) Complies with 40 CFR 152.500 Requirement for Devices and 40 CFR 

156.10 Labeling Requirements, P

(3) Displays the EPA device manufacturing facility registration number on 

the device, Pf and

(4) Is operated and maintained in accordance with manufacturer’s 

instructions Pf.
FDA Food Code 2022 Chapter 4 Equipment, Utensils, and Linens

Chapter 4 - 20

4-501.115 Manual Warewashing Equipment, Chemical Sanitization Using 

Detergent-Sanitizers. 

If a detergent-SANITIZER is used to SANITIZE in a cleaning and SANITIZING

procedure where there is no distinct water rinse between the washing and 

SANITIZING steps, the agent applied in the SANITIZING step shall be the same 

detergent-SANITIZER that is used in the washing step. 

4-501.116 Warewashing Equipment, Determining Chemical Sanitizer 

Concentration. 

Concentration of the SANITIZING solution shall be accurately determined by using 

a test kit or other device. Pf

4-502 Utensils and Temperature and Pressure Measuring Devices

4-502.11 Good Repair and Calibration. 

(A) UTENSILS shall be maintained in a state of repair or condition that complies 

with the requirements specified under Parts 4-1 and 4-2 or shall be discarded.

(B) FOOD TEMPERATURE MEASURING DEVICES shall be calibrated in accordance with 

manufacturer's specifications as necessary to ensure their accuracy. Pf

(C) Ambient air temperature, water pressure, and water TEMPERATURE MEASURING 

DEVICES shall be maintained in good repair and be accurate within the intended 

range of use. 

4-502.12 Single-Service and Single-Use Articles, Required Use.

A FOOD ESTABLISHMENT without facilities specified under Parts 4-6 and 4-7 for 

cleaning and SANITIZING KITCHENWARE and TABLEWARE shall provide only SINGLEUSE KITCHENWARE, SINGLE-SERVICE ARTICLES, and SINGLE-USE ARTICLES for use by 

FOOD EMPLOYEES and SINGLE-SERVICE ARTICLES for use by CONSUMERS. P

4-502.13 Single-Service and Single-Use Articles, Use Limitation. 

(A) SINGLE-SERVICE and SINGLE-USE ARTICLES may not be reused. 

(B) The bulk milk container dispensing tube shall be cut on the diagonal leaving 

no more than one inch protruding from the chilled dispensing head. 

4-502.14 Shells, Use Limitation.

Mollusk and crustacea shells may not be used more than once as serving 

containers.

4-6 Cleaning of Equipment and Utensils

4-601 Objective

4-601.11 Equipment, Food-Contact Surfaces, Nonfood-Contact Surfaces, 

and Utensils. 
FDA Food Code 2022 Chapter 4 Equipment, Utensils, and Linens

Chapter 4 - 21

(A) EQUIPMENT FOOD-CONTACT SURFACES and UTENSILS shall be clean to sight and 

touch. Pf 

(B) The FOOD-CONTACT SURFACES of cooking EQUIPMENT and pans shall be kept 

free of encrusted grease deposits and other soil accumulations.

(C) NonFOOD-CONTACT SURFACES of EQUIPMENT shall be kept free of an 

accumulation of dust, dirt, FOOD residue, and other debris.

4-602 Frequency

4-602.11 Equipment Food-Contact Surfaces and Utensils.

(A) Equipment food-contact surfaces and utensils shall be cleaned:

(1) Except as specified in ¶ (B) of this section, before each use with a 

different type of raw animal FOOD such as beef, FISH, lamb, pork, or 

POULTRY; P

(2) Each time there is a change from working with raw FOODS to working 

with READY-TO-EAT FOODS; P

(3) Between uses with raw fruits and vegetables and with 

TIME/TEMPERATURE CONTROL FOR SAFETY FOOD; P

(4) Before using or storing a FOOD TEMPERATURE MEASURING DEVICE; P and

(5) At any time during the operation when contamination may have 

occurred. P 

(B) Subparagraph (A)(1) of this section does not apply if the FOOD-CONTACT

SURFACE or UTENSIL is in contact with a succession of different types of raw MEAT

and POULTRY each requiring a higher cooking temperature as specified under § 

3-401.11 than the previous type.

(C) Except as specified in ¶ (D) of this section, if used with TIME/TEMPERATURE 

CONTROL FOR SAFETY FOOD, EQUIPMENT FOOD-CONTACT SURFACES and UTENSILS

shall be cleaned throughout the day at least every 4 hours. P 

(D) Surfaces of UTENSILS and EQUIPMENT contacting TIME/TEMPERATURE CONTROL 

FOR SAFETY FOOD may be cleaned less frequently than every 4 hours if: 

(1) In storage, containers of TIME/TEMPERATURE CONTROL FOR SAFETY FOOD

and their contents are maintained at temperatures specified under 

Chapter 3 and the containers are cleaned when they are empty;

(2) UTENSILS and EQUIPMENT are used to prepare FOOD in a refrigerated 

room or area that is maintained at one of the temperatures in the following 

chart and: 

(a) The utensils and equipment are cleaned at the frequency in 

the following chart that corresponds to the temperature; and
FDA Food Code 2022 Chapter 4 Equipment, Utensils, and Linens

Chapter 4 - 22

TEMPERATURE CLEANING FREQUENCY

5.0°C (41°F) or less 24 hours

>5.0°C - 7.2°C

(>41°F - 45°F)

20 hours

>7.2°C - 10.0°C

(>45°F - 50°F)

16 hours

>10.0°C - 12.8°C

(>50°F - 55°F)

10 hours

(b) The cleaning frequency based on the ambient temperature 

of the refrigerated room or area is documented in the FOOD 

ESTABLISHMENT.

(3) Containers in serving situations such as salad bars, delis, and cafeteria 

lines hold READY-TO-EAT TIME/TEMPERATURE CONTROL FOR SAFETY FOOD that 

is maintained at the temperatures specified under Chapter 3, are 

intermittently combined with additional supplies of the same FOOD that is at 

the required temperature, and the containers are cleaned at least every 24 

hours;

(4) TEMPERATURE MEASURING DEVICES are maintained in contact with FOOD, 

such as when left in a container of deli FOOD or in a roast, held at 

temperatures specified under Chapter 3;

(5) EQUIPMENT is used for storage of PACKAGED or unPACKAGED FOOD such 

as a reach-in refrigerator and the EQUIPMENT is cleaned at a frequency 

necessary to preclude accumulation of soil residues;

(6) The cleaning schedule is APPROVED based on consideration of:

(a) Characteristics of the equipment and its use,

(b) The type of food involved,

(c) The amount of food residue accumulation, and

(d) The temperature at which the food is maintained during the 

operation and the potential for the rapid and progressive 

multiplication of pathogenic or toxigenic microorganisms that are 

capable of causing foodborne disease; or

(7) In-use utensils are intermittently stored in a container of water in which 

the water is maintained at 57oC (135oF) or more and the utensils and 

container are cleaned at least every 24 hours or at a frequency necessary 

to preclude accumulation of soil residues.
FDA Food Code 2022 Chapter 4 Equipment, Utensils, and Linens

Chapter 4 - 23

(E) Except when dry cleaning methods are used as specified under § 4-603.11, 

surfaces of UTENSILS and EQUIPMENT contacting FOOD that is not 

TIME/TEMPERATURE CONTROL FOR SAFETY FOOD shall be cleaned:

(1) At any time when contamination may have occurred;

(2) At least every 24 hours for iced tea dispensers and CONSUMER selfservice UTENSILS such as tongs, scoops, or ladles;

(3) Before restocking CONSUMER self-service EQUIPMENT and UTENSILS such 

as condiment dispensers and display containers; and

(4) In EQUIPMENT such as ice bins and BEVERAGE dispensing nozzles and 

enclosed components of EQUIPMENT such as ice makers, cooking oil 

storage tanks and distribution lines, BEVERAGE and syrup dispensing lines 

or tubes, coffee bean grinders, and water vending EQUIPMENT:

(a) At a frequency specified by the manufacturer, or

(b) Absent manufacturer specifications, at a frequency 

necessary to preclude accumulation of soil or mold.

4-602.12 Cooking and Baking Equipment.

(A) The FOOD-CONTACT SURFACES of cooking and baking EQUIPMENT shall be 

cleaned at least every 24 hours. This section does not apply to hot oil cooking 

and filtering EQUIPMENT if it is cleaned as specified in Subparagraph 

4-602.11(D)(6).

(B) The cavities and door seals of microwave ovens shall be cleaned at least 

every 24 hours by using the manufacturer's recommended cleaning procedure.

4-602.13 Nonfood-Contact Surfaces.

NonFOOD-CONTACT SURFACES of EQUIPMENT shall be cleaned at a frequency 

necessary to preclude accumulation of soil residues.

4-603 Methods

4-603.11 Dry Cleaning.

(A) If used, dry cleaning methods such as brushing, scraping, and vacuuming 

shall contact only SURFACES that are soiled with dry FOOD residues that are not 

TIME/TEMPERATURE CONTROL FOR SAFETY FOOD.

(B) Cleaning EQUIPMENT used in dry cleaning FOOD-CONTACT SURFACES may not 

be used for any other purpose. 

4-603.12 Precleaning.

(A) FOOD debris on EQUIPMENT and UTENSILS shall be scraped over a waste 

disposal unit or garbage receptacle or shall be removed in a WAREWASHING

machine with a prewash cycle.

(B) If necessary for effective cleaning, UTENSILS and EQUIPMENT shall be 

preflushed, presoaked, or scrubbed with abrasives. 
FDA Food Code 2022 Chapter 4 Equipment, Utensils, and Linens

Chapter 4 - 24

4-603.13 Loading of Soiled Items, Warewashing Machines. 

Soiled items to be cleaned in a WAREWASHING machine shall be loaded into racks, 

trays, or baskets or onto conveyors in a position that:

(A) Exposes the items to the unobstructed spray from all cycles; and

(B) Allows the items to drain.

4-603.14 Wet Cleaning.

(A) EQUIPMENT FOOD-CONTACT SURFACES and UTENSILS shall be effectively 

washed to remove or completely loosen soils by using the manual or mechanical 

means necessary such as the application of detergents containing wetting agents 

and emulsifiers; acid, alkaline, or abrasive cleaners; hot water; brushes; scouring 

pads; high-pressure sprays; or ultrasonic devices. 

(B) The washing procedures selected shall be based on the type and purpose of 

the EQUIPMENT or UTENSIL, and on the type of soil to be removed.

4-603.15 Washing, Procedures for Alternative Manual Warewashing 

Equipment.

If washing in sink compartments or a WAREWASHING machine is impractical such 

as when the EQUIPMENT is fixed or the UTENSILS are too large, washing shall be 

done by using alternative manual WAREWASHING EQUIPMENT as specified in ¶ 

4-301.12(C) in accordance with the following procedures:

(A) EQUIPMENT shall be disassembled as necessary to allow access of the 

detergent solution to all parts;

(B) EQUIPMENT components and UTENSILS shall be scraped or rough 

cleaned to remove FOOD particle accumulation; and

(C) EQUIPMENT and UTENSILS shall be washed as specified under 

¶ 4-603.14(A).

4-603.16 Rinsing Procedures.

Washed UTENSILS and EQUIPMENT shall be rinsed so that abrasives are removed 

and cleaning chemicals are removed or diluted through the use of water or a 

detergent-sanitizer solution by using one of the following procedures: 

(A) Use of a distinct, separate water rinse after washing and before 

SANITIZING if using:

(1) A 3-compartment sink,

(2) Alternative manual WAREWASHING EQUIPMENT equivalent to a 3-

compartment sink as specified in ¶ 4-301.12(C), or

(3) A 3-step washing, rinsing, and SANITIZING procedure in a 

WAREWASHING system for CIP EQUIPMENT;

(B) Use of a detergent-SANITIZER as specified under § 4-501.115 if using: 
FDA Food Code 2022 Chapter 4 Equipment, Utensils, and Linens

Chapter 4 - 25

(1) Alternative WAREWASHING EQUIPMENT as specified in 

¶ 4-301.12(C) that is APPROVED for use with a detergent-sANITIZER, 

or

(2) A WAREWASHING system for CIP EQUIPMENT;

(C) Use of a nondistinct water rinse that is integrated in the hot water 

SANITIZATION immersion step of a 2-compartment sink operation;

(D) If using a WAREWASHING machine that does not recycle the SANITIZING

solution as specified under ¶ (E) of this section, or alternative manual 

WAREWASHING EQUIPMENT such as sprayers, use of a nondistinct water 

rinse that is:

(1) Integrated in the application of the SANITIZING solution, and

(2) Wasted immediately after each application; or

(E) If using a WAREWASHING machine that recycles the SANITIZING solution 

for use in the next wash cycle, use of a nondistinct water rinse that is 

integrated in the application of the SANITIZING solution.

4-7 Sanitization of Equipment and Utensils

4-701 Objective

4-701.10 Food-Contact Surfaces and Utensils.

Equipment food-contact surfaces and utensils shall be sanitized.

4-702 Frequency

4-702.11 Before Use After Cleaning.

UTENSILS and FOOD-CONTACT SURFACES of EQUIPMENT shall be SANITIZED before 

use after cleaning. P

4-703 Methods

4-703.11 Hot Water and Chemical.

After being cleaned, equipment food-contact surfaces and utensils shall be 

sanitized in: 

(A) Hot water manual operations by immersion for at least 30 seconds and 

as specified under § 4-501.111; P

(B) Hot water mechanical operations by being cycled through EQUIPMENT

that is set up as specified under §§ 4-501.15, 4-501.112, and 4-501.113 

and achieving a UTENSIL surface temperature of 71oC (160oF) as 

measured by an irreversible registering temperature indicator; P or

(C) Chemical manual or mechanical operations, including the application 

of SANITIZING chemicals by immersion, manual swabbing, brushing, or 

pressure spraying methods, using a solution as specified under § 
FDA Food Code 2022 Chapter 4 Equipment, Utensils, and Linens

Chapter 4 - 26

4-501.114. Contact times shall be consistent with those on EPAregistered label use instructions by providing:

(1) Except as specified under Subparagraph (C)(2) of this section, a 

contact time of at least 10 seconds for a chlorine solution specified 

under ¶ 4-501.114(A), P

(2) A contact time of at least 7 seconds for a chlorine solution of 50 

MG/L that has a PH of 10 or less and a temperature of at least 38oC 

(100oF) or a PH of 8 or less and a temperature of at least 24oC 

(75oF), P

(3) A contact time of at least 30 seconds for other chemical 

SANITIZING solutions, P or

(4) A contact time used in relationship with a combination of 

temperature, concentration, and PH that, when evaluated for 

efficacy, yields SANITIZATION as defined in ¶ 1-201.10(B). P

4-8 Laundering

4-801 Objective

4-801.11 Clean Linens.

Clean LINENS shall be free from FOOD residues and other soiling matter.

4-802 Frequency

4-802.11 Specifications.

(A) LINENS that do not come in direct contact with FOOD shall be laundered 

between operations if they become wet, sticky, or visibly soiled.

(B) Cloth gloves used as specified in ¶ 3-304.15(D) shall be laundered before 

being used with a different type of raw animal FOOD such as beef, FISH, lamb, 

pork or POULTRY. 

(C) LINENS that are used as specified under § 3-304.13 and cloth napkins shall be 

laundered between each use.

(D) Wet wiping cloths shall be laundered daily.

(E) Dry wiping cloths shall be laundered as necessary to prevent contamination 

of FOOD and clean serving UTENSILS. 

4-803 Methods

4-803.11 Storage of Soiled Linens. 

Soiled LINENS shall be kept in clean, nonabsorbent receptacles or clean, 

washable laundry bags and stored and transported to prevent contamination of 

FOOD, clean EQUIPMENT, clean UTENSILS, and SINGLE-SERVICE and SINGLE-USE

ARTICLES.
FDA Food Code 2022 Chapter 4 Equipment, Utensils, and Linens

Chapter 4 - 27

4-803.12 Mechanical Washing. 

(A) Except as specified in ¶ (B) of this section, LINENS shall be mechanically 

washed.

(B) In FOOD ESTABLISHMENTS in which only wiping cloths are laundered as 

specified in ¶ 4-301.15(B), the wiping cloths may be laundered in a mechanical 

washer, sink designated only for laundering wiping cloths, or a WAREWASHING or 

FOOD preparation sink that is cleaned as specified under § 4-501.14. 

4-803.13 Use of Laundry Facilities.

(A) Except as specified in ¶ (B) of this section, laundry facilities on the PREMISES

of a FOOD ESTABLISHMENT shall be used only for the washing and drying of items 

used in the operation of the establishment. 

(B) Separate laundry facilities located on the PREMISES for the purpose of general 

laundering such as for institutions providing boarding and lodging may also be 

used for laundering FOOD ESTABLISHMENT items.

4-9 Protection of Clean Items

4-901 Drying

4-901.11 Equipment and Utensils, Air-Drying Required.

After cleaning and SANITIZING, EQUIPMENT and UTENSILS:

(A) Shall be air-dried or used after adequate draining as specified in the 

first paragraph of 40 CFR 180.940 Tolerance exemptions for active and 

inert ingredients for use in antimicrobial formulations (food-contact surface 

SANITIZING solutions), before contact with FOOD; and

(B) May not be cloth dried except that UTENSILS that have been air-dried 

may be polished with cloths that are maintained clean and dry.

4-901.12 Wiping Cloths, Air-Drying Locations.

Wiping cloths laundered in a FOOD ESTABLISHMENT that does not have a 

mechanical clothes dryer as specified in ¶ 4-301.15(B) shall be air-dried in a 

location and in a manner that prevents contamination of FOOD, EQUIPMENT, 

UTENSILS, LINENS, and SINGLE-SERVICE and SINGLE-USE ARTICLES and the wiping 

cloths. This section does not apply if wiping cloths are stored after laundering in 

a SANITIZING solution as specified under § 4-501.114.

4-902 Lubricating and Reassembling

4-902.11 Food-Contact Surfaces.

Lubricants as specified under § 7-205.11 shall be applied to FOOD-CONTACT

SURFACES that require lubrication in a manner that does not contaminate FOODCONTACT SURFACES.

4-902.12 Equipment.
FDA Food Code 2022 Chapter 4 Equipment, Utensils, and Linens

Chapter 4 - 28

EQUIPMENT shall be reassembled so that FOOD-CONTACT SURFACES are not 

contaminated.

4-903 Storing

4-903.11 Equipment, Utensils, Linens, and Single-Service and Single-Use 

Articles.

(A) Except as specified in ¶ (D) of this section, cleaned EQUIPMENT and UTENSILS, 

laundered LINENS, and SINGLE-SERVICE and SINGLE-USE ARTICLES shall be stored:

(1) In a clean, dry location;

(2) Where they are not exposed to splash, dust, or other contamination; 

and

(3) At least 15 cm (6 inches) above the floor.

(B) Clean EQUIPMENT and UTENSILS shall be stored as specified under ¶ (A) of this 

section and shall be stored: 

(1) In a self-draining position that allows air drying; and

(2) Covered or inverted.

(C) SINGLE-SERVICE and SINGLE-USE ARTICLES shall be stored as specified under ¶ 

(A) of this section and shall be kept in the original protective PACKAGE or stored 

by using other means that afford protection from contamination until used.

(D) Items that are kept in closed PACKAGES may be stored less than 15 cm (6 

inches) above the floor on dollies, pallets, racks, and skids that are designed as 

specified under § 4-204.122. 

4-903.12 Prohibitions.

(A) Except as specified in ¶ (B) of this section, cleaned and SANITIZED EQUIPMENT, 

UTENSILS, laundered LINENS, and SINGLE-SERVICE and SINGLE-USE ARTICLES may 

not be stored: 

(1) In locker rooms;

(2) In toilet rooms; Pf

(3) In garbage rooms;

(4) In mechanical rooms;

(5) Under sewer lines that are not shielded to intercept potential drips;

(6) Under leaking water lines including leaking automatic fire sprinkler 

heads or under lines on which water has condensed;

(7) Under open stairwells; or

(8) Under other sources of contamination.
FDA Food Code 2022 Chapter 4 Equipment, Utensils, and Linens

Chapter 4 - 29

(B) Laundered LINENS and SINGLE-SERVICE and SINGLE-USE ARTICLES that are 

PACKAGED or in a facility such as a cabinet may be stored in a locker room. 

4-904 Preventing Contamination

4-904.11 Kitchenware and Tableware.

(A) SINGLE-SERVICE and SINGLE-USE ARTICLES and cleaned and SANITIZED UTENSILS

shall be handled, displayed, and dispensed so that contamination of FOOD- and 

lip-contact surfaces is prevented.

(B) Knives, forks, and spoons that are not prewrapped shall be presented so that 

only the handles are touched by EMPLOYEES and by CONSUMERS if CONSUMER selfservice is provided.

(C) Except as specified under ¶ (B) of this section, SINGLE-SERVICE ARTICLES that 

are intended for FOOD- or lip-contact shall be furnished for CONSUMER self-service 

with the original individual wrapper intact or from an APPROVED dispenser. 

4-904.12 Soiled and Clean Tableware.

Soiled TABLEWARE shall be removed from CONSUMER eating and drinking areas 

and handled so that clean TABLEWARE is not contaminated.

4-904.13 Preset Tableware.

(A) Except as specified in ¶ (B) of this section, TABLEWARE that is preset shall be 

protected from contamination by being wrapped, covered, or inverted.

(B) Preset TABLEWARE may be exposed if:

(1) Unused settings are removed when a CONSUMER is seated; or

(2) Settings not removed when a CONSUMER is seated are cleaned and 

SANITIZED before further use.

4-904.14 Rinsing Equipment and Utensils after Cleaning and Sanitizing.

After being cleaned and SANITIZED, EQUIPMENT and UTENSILS shall not be rinsed 

before air drying or use unless:

(A) The rinse is applied directly from a potable water supply by a 

warewashing machine that is maintained and operated as specified under 

Subparts 4-204 and 4-501; and 

(B) The rinse is applied only after the EQUIPMENT and UTENSILS have been 

SANITIZED by the application of hot water or by the application of a 

chemical SANITIZER solution whose EPA-registered label use instructions 

call for rinsing off the SANITIZER after it is applied in a commercial 

WAREWASHING machine.
FDA Food Code 2022 Chapter 5. Water, Plumbing, and Waste

Chapter 5 - 1

Chapter 5 Water, Plumbing, 

and Waste

Parts:

5-1 Water

5-2 Plumbing System

5-3 Mobile Water Tank and Mobile FOOD Establishment Water Tank

5-4 Sewage, Other Liquid Waste, and Rainwater

5-5 Refuse, Recyclables, and Returnables

5-1 Water

5-101 Source

5-101.11 Approved System.

DRINKING WATER shall be obtained from an APPROVED source that is:

(A) A public water system; P or

(B) A nonPUBLIC WATER SYSTEM that is constructed, maintained, and 

operated according to LAW. P

5-101.12 System Flushing and Disinfection.

A DRINKING WATER system shall be flushed and disinfected before being placed in 

service after construction, repair, or modification and after an emergency 

situation, such as a flood, that may introduce contaminants to the system. P 

5-101.13 Bottled Drinking Water.

BOTTLED DRINKING WATER used or sold in a FOOD ESTABLISHMENT shall be obtained

from APPROVED sources in accordance with 21 CFR 129 - Processing and 

Bottling of Bottled DRINKING WATER. P

5-102 Quality

5-102.11 Standards.

Except as specified under § 5-102.12:

(A) Water from a PUBLIC WATER SYSTEM shall meet 40 CFR 141 - National 

Primary Drinking Water Regulations and state DRINKING WATER quality 

standards; P and

(B) Water from a nonPUBLIC WATER SYSTEM shall meet state DRINKING 

WATER quality standards. P 
FDA Food Code 2022 Chapter 5. Water, Plumbing, and Waste

Chapter 5 - 2

5-102.12 Nondrinking Water.

(A) A nonDRINKING WATER supply shall be used only if its use is APPROVED. P 

(B) NonDRINKING WATER shall be used only for nonculinary purposes such as air 

conditioning, nonFOOD EQUIPMENT cooling, and fire protection. P 

5-102.13 Sampling. 

Except when used as specified under § 5-102.12, water from a nonPUBLIC WATER 

SYSTEM shall be sampled and tested at least annually and as required by state 

water quality regulations. Pf 

5-102.14 Sample Report.

The most recent sample report for the nonPUBLIC WATER SYSTEM shall be retained 

on file in the FOOD ESTABLISHMENT or the report shall be maintained as specified 

by state water quality regulations.

5-103 Quantity and Availability

5-103.11 Capacity.

(A) The water source and system shall be of sufficient capacity to meet the peak 

water demands of the FOOD ESTABLISHMENT. Pf 

(B) Hot water generation and distribution systems shall be sufficient to meet the 

peak hot water demands throughout the FOOD ESTABLISHMENT. Pf 

5-103.12 Pressure. 

Water under pressure shall be provided to all fixtures, EQUIPMENT, and nonFOOD

EQUIPMENT that are required to use water except that water supplied as specified 

under ¶¶ 5-104.12(A) and (B) to a TEMPORARY FOOD ESTABLISHMENT or in 

response to a temporary interruption of a water supply need not be under 

pressure. Pf 

5-104 Distribution, Delivery, and Retention

5-104.11 System.

Water shall be received from the source through the use of: 

(A) An APPROVED public water main; Pf or

(B) One or more of the following that shall be constructed, maintained, and 

operated according to LAW: Pf 

(1) Nonpublic water main, water pumps, pipes, hoses, connections, 

and other appurtenances, Pf

(2) Water transport vehicles, Pf or

(3) Water containers. Pf 

5-104.12 Alternative Water Supply. 
FDA Food Code 2022 Chapter 5. Water, Plumbing, and Waste

Chapter 5 - 3

Water meeting the requirements specified under Subparts 5-101, 5-102, and 

5-103 shall be made available for a mobile facility, for a TEMPORARY FOOD

ESTABLISHMENT without a permanent water supply, and for a FOOD ESTABLISHMENT

with a temporary interruption of its water supply through: 

(A) A supply of containers of commercially BOTTLED DRINKING WATER; Pf

(B) One or more closed portable water containers; Pf

(C) An enclosed vehicular water tank; Pf

(D) An on-PREMISES water storage tank; Pf or

(E) Piping, tubing, or hoses connected to an adjacent APPROVED source. Pf

5-2 Plumbing System

5-201 Materials

5-201.11 Approved.

(A) A PLUMBING SYSTEM and hoses conveying water shall be constructed and 

repaired with APPROVED materials according to LAW. P

(B) A water filter shall be made of SAFE MATERIALS. P 

5-202 Design, Construction, and Installation

5-202.11 Approved System and Cleanable Fixtures.

(A) A PLUMBING SYSTEM shall be designed, constructed, and installed according to 

LAW. P 

(B) A plumbing fixture such as a handwashing sink, toilet, or urinal shall be easily 

cleanable.

5-202.12 Handwashing Sink, Installation.

(A) A HANDWASHING SINK shall be equipped to provide water at a temperature of at 

least 29.4oC (85oF) through a mixing valve or combination faucet. Pf 

(B) A steam mixing valve may not be used at a HANDWASHING SINK.

(C) A self-closing, slow-closing, or metering faucet shall provide a flow of water 

for at least 15 seconds without the need to reactivate the faucet. 

(D) An automatic handwashing facility shall be installed in accordance with 

manufacturer’s instructions.

5-202.13 Backflow Prevention, Air Gap.

An air gap between the water supply inlet and the flood level rim of the PLUMBING 

FIXTURE, EQUIPMENT, or nonFOOD EQUIPMENT shall be at least twice the diameter 

of the water supply inlet and may not be less than 25 mm (1 inch). P 

5-202.14 Backflow Prevention Device, Design Standard. 
FDA Food Code 2022 Chapter 5. Water, Plumbing, and Waste

Chapter 5 - 4

A backflow or backsiphonage prevention device installed on a water supply 

system shall meet American Society of Sanitary Engineering (A.S.S.E.) 

standards for construction, installation, maintenance, inspection, and testing for 

that specific application and type of device. P

5-202.15 Conditioning Device, Design. 

A water filter, screen, and other water conditioning device installed on water lines 

shall be designed to facilitate disassembly for periodic servicing and cleaning. A 

water filter element shall be of the replaceable type.

5-203 Numbers and Capacities

5-203.11 Handwashing Sinks.

(A) Except as specified in ¶¶ (B) of this section, at least 1 HANDWASHING SINK, a 

number of HANDWASHING SINKS necessary for their convenient use by EMPLOYEES

in areas specified under § 5-204.11, and not fewer than the number of 

HANDWASHING SINKS required by LAW shall be provided. Pf

(B) If APPROVED and capable of removing the types of soils encountered in the 

FOOD operations involved, automatic handwashing facilities may be substituted 

for HANDWASHING SINKS in a FOOD ESTABLISHMENT that has at least 1 HANDWASHING 

SINK. 

5-203.12 Toilets and Urinals.

At least 1 toilet and not fewer than the toilets required by LAW shall be provided. 

If authorized by LAW and urinals are substituted for toilets, the substitution shall 

be done as specified in LAW. 

5-203.13 Service Sink.

(A) At least 1 service sink or 1 curbed cleaning facility equipped with a floor drain 

shall be provided and conveniently located for the cleaning of mops or similar wet 

floor cleaning tools and for the disposal of mop water and similar liquid waste. 

(B) Toilets and urinals may not be used as a service sink for the disposal of mop 

water and similar liquid waste.

5-203.14 Backflow Prevention Device, When Required.

A PLUMBING SYSTEM shall be installed to preclude backflow of a solid, liquid, or 

gas contaminant into the water supply system at each point of use at the FOOD

ESTABLISHMENT, including on a hose bibb if a hose is attached or on a hose bibb if 

a hose is not attached and backflow prevention is required by LAW, by: 

(A) Providing an air gap as specified under § 5-202.13 P; or

(B) Installing an APPROVED backflow prevention device as specified under 

§ 5-202.14. P 

5-203.15 Backflow Prevention Device, Carbonator. 
FDA Food Code 2022 Chapter 5. Water, Plumbing, and Waste

Chapter 5 - 5

(A) If not provided with an air gap as specified under §5-202.13, a dual check 

valve with an intermediate vent preceded by a screen of not less than 100 mesh 

to 25.4 mm (100 mesh to 1 inch) shall be installed upstream from a carbonating 

device and downstream from any copper in the water supply line.P 

(B) A dual check valve attached to the carbonator need not be of the vented type 

if an air gap or vented backflow prevention device has been otherwise provided 

as specified under ¶ (A) of this section.

5-204 Location and Placement

5-204.11 Handwashing Sinks.

A HANDWASHING SINK shall be located: 

(A) To allow convenient use by EMPLOYEES in FOOD preparation, FOOD

dispensing, and WAREWASHING areas; Pf and

(B) In, or immediately adjacent to, toilet rooms. Pf 

5-204.12 Backflow Prevention Device, Location. 

A backflow prevention device shall be located so that it may be serviced and 

maintained. 

5-204.13 Conditioning Device, Location. 

A water filter, screen, and other water conditioning device installed on water lines 

shall be located to facilitate disassembly for periodic servicing and cleaning. 

5-205 Operation and Maintenance

5-205.11 Using a Handwashing Sink. 

(A) A HANDWASHING SINK shall be maintained so that it is accessible at all times 

for EMPLOYEE use. Pf

(B) A HANDWASHING SINK may not be used for purposes other than handwashing. Pf 

(C) An automatic handwashing facility shall be used in accordance with 

manufacturer’s instructions. Pf 

5-205.12 Prohibiting a Cross Connection.

(A) A PERSON may not create a cross connection by connecting a pipe or conduit 

between the DRINKING WATER system and a nonDRINKING WATER system or a water 

system of unknown quality.P

(B) The piping of a nonDRINKING WATER system shall be durably identified so that 

it is readily distinguishable from piping that carries DRINKING WATER. Pf 

5-205.13 Scheduling Inspection and Service for a Water System Device. 

A device such as a water treatment device or backflow preventer shall be 

scheduled for inspection and service, in accordance with manufacturer's 

instructions and as necessary to prevent device failure based on local water 
FDA Food Code 2022 Chapter 5. Water, Plumbing, and Waste

Chapter 5 - 6

conditions, and records demonstrating inspection and service shall be 

maintained by the PERSON IN CHARGE. Pf

5-205.14 Water Reservoir of Fogging Devices, Cleaning.

(A) A reservoir that is used to supply water to a device such as a produce fogger 

shall be: 

(1) Maintained in accordance with manufacturer's specifications; P and

(2) Cleaned in accordance with manufacturer's specifications or according 

to the procedures specified under ¶ (B) of this section, whichever is more 

stringent. P 

(B) Cleaning procedures shall include at least the following steps and shall be 

conducted at least once a week: 

(1) Draining and complete disassembly of the water and aerosol contact 

parts; P

(2) Brush-cleaning the reservoir, aerosol tubing, and discharge nozzles 

with a suitable detergent solution; P

(3) Flushing the complete system with water to remove the detergent 

solution and particulate accumulation; P and

(4) Rinsing by immersing, spraying, or swabbing the reservoir, aerosol 

tubing, and discharge nozzles with at least 50 MG/L hypochlorite solution. P 

5-205.15 System Maintained in Good Repair.

A plumbing system shall be: 

(A) Repaired according to LAW; P and

(B) Maintained in good repair.

5-3 Mobile Water Tank and Mobile FOOD Establishment Water Tank

5-301 Materials

5-301.11 Approved.

Materials that are used in the construction of a mobile water tank, mobile FOOD

ESTABLISHMENT water tank, and appurtenances shall be:

(A) Safe; P

(B) Durable, CORROSION-RESISTANT, and nonabsorbent; and

(C) Finished to have a SMOOTH, EASILY CLEANABLE surface. 

5-302 Design and Construction

5-302.11 Enclosed System, Sloped to Drain. 

A mobile water tank shall be: 
FDA Food Code 2022 Chapter 5. Water, Plumbing, and Waste

Chapter 5 - 7

(A) Enclosed from the filling inlet to the discharge outlet; and

(B) Sloped to an outlet that allows complete drainage of the tank. 

5-302.12 Inspection and Cleaning Port, Protected and Secured.

If a water tank is designed with an access port for inspection and cleaning, the 

opening shall be in the top of the tank and: 

(A) Flanged upward at least 13 mm (one-half inch); and

(B) Equipped with a port cover assembly that is:

(1) Provided with a gasket and a device for securing the cover in 

place, and

(2) Flanged to overlap the opening and sloped to drain. 

5-302.13 "V" Type Threads, Use Limitation. 

A fitting with "V" type threads on a water tank inlet or outlet shall be allowed only 

when a hose is permanently attached. 

5-302.14 Tank Vent, Protected.

If provided, a water tank vent shall terminate in a downward direction and shall 

be covered with: 

(A) 16 mesh to 25.4 mm (16 mesh to 1 inch) screen or equivalent when 

the vent is in a protected area; or

(B) A protective filter when the vent is in an area that is not protected from

windblown dirt and debris. 

5-302.15 Inlet and Outlet, Sloped to Drain. 

(A) A water tank and its inlet and outlet shall be sloped to drain.

(B) A water tank inlet shall be positioned so that it is protected from contaminants 

such as waste discharge, road dust, oil, or grease.

5-302.16 Hose, Construction and Identification.

A hose used for conveying DRINKING WATER from a water tank shall be: 

(A) Safe; P

(B) Durable, CORROSION-RESISTANT, and nonabsorbent;

(C) Resistant to pitting, chipping, crazing, scratching, scoring, distortion, 

and decomposition;

(D) Finished with a SMOOTH interior surface; and

(E) Clearly and durably identified as to its use if not permanently attached. 

5-303 Numbers and Capacities

5-303.11 Filter, Compressed Air.
FDA Food Code 2022 Chapter 5. Water, Plumbing, and Waste

Chapter 5 - 8

A filter that does not pass oil or oil vapors shall be installed in the air supply line 

between the compressor and DRINKING WATER system when compressed air is 

used to pressurize the water tank system. P 

5-303.12 Protective Cover or Device. 

A cap and keeper chain, closed cabinet, closed storage tube, or other APPROVED

protective cover or device shall be provided for a water inlet, outlet, and hose. 

5-303.13 Mobile Food Establishment Tank Inlet.

A mobile FOOD ESTABLISHMENT'S water tank inlet shall be: 

(A) 19.1 mm (three-fourths inch) in inner diameter or less; and

(B) Provided with a hose connection of a size or type that will prevent its 

use for any other service. 

5-304 Operation and Maintenance

5-304.11 System Flushing and Sanitization. 

A water tank, pump, and hoses shall be flushed and SANITIZED before being 

placed in service after construction, repair, modification, and periods of nonuse. P 

5-304.12 Using a Pump and Hoses, Backflow Prevention.

A PERSON shall operate a water tank, pump, and hoses so that backflow and 

other contamination of the water supply are prevented. 

5-304.13 Protecting Inlet, Outlet, and Hose Fitting. 

If not in use, a water tank and hose inlet and outlet fitting shall be protected using 

a cover or device as specified under § 5-303.12. 

5-304.14 Tank, Pump, and Hoses, Dedication.

(A) Except as specified in ¶ (B) of this section, a water tank, pump, and hoses 

used for conveying DRINKING WATER shall be used for no other purpose. P 

(B) Water tanks, pumps, and hoses APPROVED for liquid FOODS may be used for 

conveying DRINKING WATER if they are cleaned and SANITIZED before they are used 

to convey water. 
FDA Food Code 2022 Chapter 5. Water, Plumbing, and Waste

Chapter 5 - 9

5-4 Sewage, Other Liquid Waste, and Rainwater

5-401 Mobile Holding Tank

5-401.11 Capacity and Drainage. 

A SEWAGE holding tank in a mobile FOOD ESTABLISHMENT shall be:

(A) Sized 15 percent larger in capacity than the water supply tank; and

(B) Sloped to a drain that is 25 mm (1 inch) in inner diameter or greater, 

equipped with a shut-off valve.

5-402 Retention, Drainage, and Delivery

Design, construction, and installation

5-402.10 Establishment Drainage System. 

FOOD ESTABLISHMENT drainage systems, including grease traps, that convey 

SEWAGE shall be designed and installed as specified under ¶ 5-202.11(A). 

5-402.11 Backflow Prevention.

(A) Except as specified in ¶¶ (B), (C), and (D) of this section, a direct connection 

may not exist between the SEWAGE system and a drain originating from 

EQUIPMENT in which FOOD, portable EQUIPMENT, or UTENSILS are placed. P

(B) Paragraph (A) of this section does not apply to floor drains that originate in 

refrigerated spaces that are constructed as an integral part of the building. 

(C) If allowed by LAW, a WAREWASHING machine may have a direct connection 

between its waste outlet and a floor drain when the machine is located within 1.5 

m (5 feet) of a trapped floor drain and the machine outlet is connected to the inlet 

side of a properly vented floor drain trap.

(D) If allowed by LAW, a WAREWASHING or culinary sink may have a direct 

connection. 

Location and placement

5-402.12 Grease Trap. 

If used, a grease trap shall be located to be easily accessible for cleaning. 

Operation and maintenance

5-402.13 Conveying Sewage.

SEWAGE shall be conveyed to the point of disposal through an APPROVED sanitary 

SEWAGE system or other system, including use of SEWAGE transport vehicles, 

waste retention tanks, pumps, pipes, hoses, and connections that are 

constructed, maintained, and operated according to LAW.

P 
FDA Food Code 2022 Chapter 5. Water, Plumbing, and Waste

Chapter 5 - 10

5-402.14 Removing Mobile Food Establishment Wastes. 

SEWAGE and other liquid wastes shall be removed from a mobile FOOD

ESTABLISHMENT at an APPROVED waste SERVICING AREA or by a SEWAGE transport 

vehicle in such a way that a public health HAZARD or nuisance is not created. Pf 

5-402.15 Flushing a Waste Retention Tank.

A tank for liquid waste retention shall be thoroughly flushed and drained in a 

sanitary manner during the servicing operation. 

5-403 Disposal Facility

Design and construction

5-403.11 Approved Sewage Disposal System.

SEWAGE shall be disposed through an APPROVED facility that is: 

(A) A public SEWAGE treatment plant; P or

(B) An individual SEWAGE disposal system that is sized, constructed, 

maintained, and operated according to LAW. P 

5-403.12 Other Liquid Wastes and Rainwater. 

Condensate drainage and other nonSEWAGE liquids and rainwater shall be 

drained from point of discharge to disposal according to LAW.

5-5 Refuse, Recyclables, and Returnables

5-501 Facilities on the Premises

Materials, design, construction, and installation

5-501.10 Indoor Storage Area.

If located within the FOOD ESTABLISHMENT, a storage area for REFUSE, recyclables, 

and returnables shall meet the requirements specified under §§ 6-101.11, 

6-201.11 - 6-201.18, 6-202.15, and 6-202.16. 

5-501.11 Outdoor Storage Surface.

An outdoor storage surface for REFUSE, recyclables, and returnables shall be 

constructed of nonabsorbent material such as concrete or asphalt and shall be 

SMOOTH, durable, and sloped to drain. 

5-501.12 Outdoor Enclosure.

If used, an outdoor enclosure for REFUSE, recyclables, and returnables shall be 

constructed of durable and cleanable materials.

5-501.13 Receptacles. 
FDA Food Code 2022 Chapter 5. Water, Plumbing, and Waste

Chapter 5 - 11

(A) Except as specified in ¶ (B) of this section, receptacles and waste handling 

units for REFUSE, recyclables, and returnables and for use with materials 

containing FOOD residue shall be durable, cleanable, insect- and rodent-resistant, 

leakproof, and nonabsorbent. 

(B) Plastic bags and wet strength paper bags may be used to line receptacles for 

storage inside the FOOD ESTABLISHMENT, or within closed outside receptacles.

5-501.14 Receptacles in Vending Machines. 

Except for a receptacle for BEVERAGE bottle crown closures, a REFUSE receptacle 

may not be located within a VENDING MACHINE. 

5-501.15 Outside Receptacles.

(A) Receptacles and waste handling units for REFUSE, recyclables, and 

returnables used with materials containing FOOD residue and used outside the 

FOOD ESTABLISHMENT shall be designed and constructed to have tight-fitting lids, 

doors, or covers.

(B) Receptacles and waste handling units for REFUSE and recyclables such as an 

on-site compactor shall be installed so that accumulation of debris and insect and 

rodent attraction and harborage are minimized and effective cleaning is facilitated 

around and, if the unit is not installed flush with the base pad, under the unit. 

Numbers and capacities

5-501.16 Storage Areas, Rooms, and Receptacles, Capacity and 

Availability.

(A) An inside storage room and area and outside storage area and enclosure, 

and receptacles shall be of sufficient capacity to hold REFUSE, recyclables, and 

returnables that accumulate.

(B) A receptacle shall be provided in each area of the FOOD ESTABLISHMENT or 

PREMISES where REFUSE is generated or commonly discarded, or where 

recyclables or returnables are placed. 

(C) If disposable towels are used at handwashing lavatories, a waste receptacle 

shall be located at each lavatory or group of adjacent lavatories. 

5-501.17 Toilet Room Receptacle, Covered. 

A toilet room used by females shall be provided with a covered receptacle for 

sanitary napkins. 

5-501.18 Cleaning Implements and Supplies.

(A) Except as specified in ¶ (B) of this section, suitable cleaning implements and 

supplies such as high pressure pumps, hot water, steam, and detergent shall be 

provided as necessary for effective cleaning of receptacles and waste handling 

units for REFUSE, recyclables, and returnables. 

(B) If APPROVED, off-PREMISES-based cleaning services may be used if onPREMISES cleaning implements and supplies are not provided.
FDA Food Code 2022 Chapter 5. Water, Plumbing, and Waste

Chapter 5 - 12

Location and placement

5-501.19 Storage Areas, Redeeming Machines, Receptacles and Waste 

Handling Units, Location. 

(A) An area designated for REFUSE, recyclables, returnables, and, except as 

specified in ¶ (B) of this section, a redeeming machine for recyclables or 

returnables shall be located so that it is separate from FOOD, EQUIPMENT, 

UTENSILS, LINENS, and SINGLE-SERVICE and SINGLE-USE ARTICLES and a public 

health HAZARD or nuisance is not created.

(B) A redeeming machine may be located in the PACKAGED FOOD storage area or 

CONSUMER area of a FOOD ESTABLISHMENT if FOOD, EQUIPMENT, UTENSILS, LINENS, 

and SINGLE-SERVICE and SINGLE-USE ARTICLES are not subject to contamination 

from the machines and a public health HAZARD or nuisance is not created.

(C) The location of receptacles and waste handling units for REFUSE, recyclables, 

and returnables may not create a public health HAZARD or nuisance or interfere 

with the cleaning of adjacent space. 

Operation and maintenance

5-501.110 Storing Refuse, Recyclables, and Returnables.

REFUSE, recyclables, and returnables shall be stored in receptacles or waste 

handling units so that they are inaccessible to insects and rodents. 

5-501.111 Areas, Enclosures, and Receptacles, Good Repair.

Storage areas, enclosures, and receptacles for REFUSE, recyclables, and 

returnables shall be maintained in good repair. 

5-501.112 Outside Storage Prohibitions.

(A) Except as specified in ¶ (B) of this section, REFUSE receptacles not meeting 

the requirements specified under ¶ 5-501.13(A) such as receptacles that are not 

rodent-resistant, unprotected plastic bags and paper bags, or baled units that 

contain materials with FOOD residue may not be stored outside. 

(B) Cardboard or other packaging material that does not contain FOOD residues 

and that is awaiting regularly scheduled delivery to a recycling or disposal site 

may be stored outside without being in a covered receptacle if it is stored so that 

it does not create a rodent harborage problem. 

5-501.113 Covering Receptacles. 

Receptacles and waste handling units for REFUSE, recyclables, and returnables 

shall be kept covered: 

(A) Inside the FOOD ESTABLISHMENT if the receptacles and units:

(1) Contain FOOD residue and are not in continuous use; or

(2) After they are filled; and

(B) With tight-fitting lids or doors if kept outside the FOOD ESTABLISHMENT. 
FDA Food Code 2022 Chapter 5. Water, Plumbing, and Waste

Chapter 5 - 13

5-501.114 Using Drain Plugs.

Drains in receptacles and waste handling units for REFUSE, recyclables, and 

returnables shall have drain plugs in place.

5-501.115 Maintaining Refuse Areas and Enclosures.

A storage area and enclosure for REFUSE, recyclables, or returnables shall be 

maintained free of unnecessary items, as specified under § 6-501.114, and 

clean. 

5-501.116 Cleaning Receptacles. 

(A) Receptacles and waste handling units for REFUSE, recyclables, and 

returnables shall be thoroughly cleaned in a way that does not contaminate 

FOOD, EQUIPMENT, UTENSILS, LINENS, or SINGLE-SERVICE and SINGLE-USE ARTICLES, 

and waste water shall be disposed of as specified under § 5-402.13. 

(B) Soiled receptacles and waste handling units for REFUSE, recyclables, and 

returnables shall be cleaned at a frequency necessary to prevent them from 

developing a buildup of soil or becoming attractants for insects and rodents. 

5-502 Removal

5-502.11 Frequency.

REFUSE, recyclables, and returnables shall be removed from the PREMISES at a 

frequency that will minimize the development of objectionable odors and other 

conditions that attract or harbor insects and rodents. 

5-502.12 Receptacles or Vehicles.

REFUSE, recyclables, and returnables shall be removed from the PREMISES by 

way of: 

(A) Portable receptacles that are constructed and maintained according to 

LAW; or

(B) A transport vehicle that is constructed, maintained, and operated 

according to LAW. 

5-503 Facilities for Disposal and Recycling

5-503.11 Community or Individual Facility. 

Solid waste not disposed of through the SEWAGE system such as through grinders 

and pulpers shall be recycled or disposed of in an APPROVED public or private 

community recycling or REFUSE facility; or solid waste shall be disposed of in an 

individual REFUSE facility such as a landfill or incinerator which is sized, 

constructed, maintained, and operated according to LAW. 
FDA Food Code 2022 Chapter 6. Physical Facilities

Chapter 6 - 1

Chapter 6 Physical Facilities

Parts:

6-1 Materials for Construction and Repair

6-2 Design, Construction, and Installation

6-3 Numbers and Capacities

6-4 Location and Placement

6-5 Maintenance and Operation

6-1 Materials for Construction and Repair

6-101 Indoor Areas

6-101.11 Surface Characteristics.

(A) Except as specified in ¶ (B) of this section, materials for indoor floor, wall, and 

ceiling surfaces under conditions of normal use shall be: 

(1) SMOOTH, durable, and EASILY CLEANABLE for areas where FOOD

ESTABLISHMENT operations are conducted;

(2) Closely woven and EASILY CLEANABLE carpet for carpeted areas; and

(3) Nonabsorbent for areas subject to moisture such as FOOD preparation 

areas, walk-in refrigerators, WAREWASHING areas, toilet rooms, mobile 

FOOD ESTABLISHMENT SERVICING AREAS, and areas subject to flushing or 

spray cleaning methods. 

(B) In a temporary food establishment: 

(1) If graded to drain, a floor may be concrete, machine-laid asphalt, or dirt 

or gravel if it is covered with mats, removable platforms, duckboards, or 

other APPROVED materials that are effectively treated to control dust and 

mud; and

(2) Walls and ceilings may be constructed of a material that protects the 

interior from the weather and windblown dust and debris.

6-102 Outdoor Areas

6-102.11 Surface Characteristics.

(A) The outdoor walking and driving areas shall be surfaced with concrete, 

asphalt, or gravel or other materials that have been effectively treated to 

minimize dust, facilitate maintenance, and prevent muddy conditions.

(B) Exterior surfaces of buildings and mobile FOOD ESTABLISHMENTS shall be of 

weather-resistant materials and shall comply with LAW. 
FDA Food Code 2022 Chapter 6. Physical Facilities

Chapter 6 - 2

(C) Outdoor storage areas for REFUSE, recyclables, or returnables shall be of 

materials specified under §§ 5-501.11 and 5-501.12.

6-2 Design, Construction, and Installation

6-201 Cleanability

6-201.11 Floors, Walls, and Ceilings.

Except as specified under § 6-201.14 and except for antislip floor coverings or 

applications that may be used for safety reasons, floors, floor coverings, walls, 

wall coverings, and ceilings shall be designed, constructed, and installed so they 

are SMOOTH and EASILY CLEANABLE. 

6-201.12 Floors, Walls, and Ceilings, Utility Lines.

(A) Utility service lines and pipes may not be unnecessarily exposed.

(B) Exposed utility service lines and pipes shall be installed so they do not 

obstruct or prevent cleaning of the floors, walls, or ceilings.

(C) Exposed horizontal utility service lines and pipes may not be installed on the 

floor. 

6-201.13 Floor and Wall Junctures, Coved, and Enclosed or Sealed.

(A) In FOOD ESTABLISHMENTS in which cleaning methods other than water flushing 

are used for cleaning floors, the floor and wall junctures shall be coved and 

closed to no larger than 1 mm (one thirty-second inch). 

(B) The floors in FOOD ESTABLISHMENTS in which water flush cleaning methods are 

used shall be provided with drains and be graded to drain, and the floor and wall 

junctures shall be coved and SEALED. 

6-201.14 Floor Carpeting, Restrictions and Installation.

(A) A floor covering such as carpeting or similar material may not be installed as 

a floor covering in FOOD preparation areas, walk-in refrigerators, WAREWASHING

areas, toilet room areas where handwashing lavatories, toilets, and urinals are 

located, REFUSE storage rooms, or other areas where the floor is subject to 

moisture, flushing, or spray cleaning methods. 

(B) If carpeting is installed as a floor covering in areas other than those specified 

under ¶ (A) of this section, it shall be: 

(1) Securely attached to the floor with a durable mastic, by using a stretch 

and tack method, or by another method; and

(2) Installed tightly against the wall under the coving or installed away from 

the wall with a space between the carpet and the wall and with the edges 

of the carpet secured by metal stripping or some other means. 

6-201.15 Floor Covering, Mats and Duckboards.

Mats and duckboards shall be designed to be removable and EASILY CLEANABLE. 
FDA Food Code 2022 Chapter 6. Physical Facilities

Chapter 6 - 3

6-201.16 Wall and Ceiling Coverings and Coatings.

(A) Wall and ceiling covering materials shall be attached so that they are EASILY 

CLEANABLE. 

(B) Except in areas used only for dry storage, concrete, porous blocks, or bricks 

used for indoor wall construction shall be finished and SEALED to provide a 

SMOOTH, nonabsorbent, EASILY CLEANABLE surface. 

6-201.17 Walls and Ceilings, Attachments.

(A) Except as specified in ¶ (B) of this section, attachments to walls and ceilings 

such as light fixtures, mechanical room ventilation system components, vent 

covers, wall mounted fans, decorative items, and other attachments shall be 

EASILY CLEANABLE. 

(B) In a CONSUMER area, wall and ceiling surfaces and decorative items and 

attachments that are provided for ambiance need not meet this requirement if

they are kept clean. 

6-201.18 Walls and Ceilings, Studs, Joists, and Rafters.

Except for TEMPORARY FOOD ESTABLISHMENTS, studs, joists, and rafters may not 

be exposed in areas subject to moisture. 

6-202 Functionality

6-202.11 Light Bulbs, Protective Shielding.

(A) Except as specified in ¶ (B) of this section, light bulbs shall be shielded, 

coated, or otherwise shatter-resistant in areas where there is exposed FOOD; 

clean EQUIPMENT, UTENSILS, and LINENS; or unwrapped SINGLE-SERVICE and 

SINGLE-USE ARTICLES. 

(B) Shielded, coated, or otherwise shatter-resistant bulbs need not be used in 

areas used only for storing FOOD in unopened packages, if: 

(1) The integrity of the packages cannot be affected by broken glass 

falling onto them; and

(2) The packages are capable of being cleaned of debris from broken 

bulbs before the packages are opened.

(C) An infrared or other heat lamp shall be protected against breakage by a 

shield surrounding and extending beyond the bulb so that only the face of the 

bulb is exposed. 

6-202.12 Heating, Ventilating, Air Conditioning System Vents. 

Heating, ventilating, and air conditioning systems shall be designed and installed 

so that make-up air intake and exhaust vents do not cause contamination of 

FOOD, FOOD-CONTACT SURFACES, EQUIPMENT, or UTENSILS.

6-202.13 Insect Control Devices, Design and Installation.
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Chapter 6 - 4

(A) Insect control devices that are used to electrocute or stun flying insects shall 

be designed to retain the insect within the device. 

(B) Insect control devices shall be installed so that: 

(1) The devices are not located over a FOOD preparation area; and

(2) Dead insects and insect fragments are prevented from being impelled 

onto or falling on exposed FOOD; clean EQUIPMENT, UTENSILS, and LINENS; 

and unwrapped SINGLE-SERVICE and SINGLE-USE ARTICLES.

6-202.14 Toilet Rooms, Enclosed.

Except where a toilet room is located outside a food establishment and does not 

open directly into the food establishment such as a toilet room that is provided by 

the management of a shopping mall, a toilet room located on the PREMISES shall 

be completely enclosed and provided with a tight-fitting and self-closing door. 

6-202.15 Outer Openings, Protected.

(A) Except as specified in ¶¶ (B), (C), and (E) and under ¶ (D) of this section, 

outer openings of a FOOD ESTABLISHMENT shall be protected against the entry of 

insects and rodents by: 

(1) Filling or closing holes and other gaps along floors, walls, and ceilings;

(2) Closed, tight-fitting windows; and

(3) Solid, self-closing, tight-fitting doors. 

(B) Paragraph (A) of this section does not apply if a food establishment opens 

into a larger structure, such as a mall, airport, or office building, or into an 

attached structure, such as a porch, and the outer openings from the larger or 

attached structure are protected against the entry of insects and rodents. 

(C) Exterior doors used as exits need not be self-closing if they are:

(1) Solid and tight-fitting;

(2) Designated for use only when an emergency exists, by the fire 

protection authority that has jurisdiction over the food establishment; and

(3) Limited-use so they are not used for entrance or exit from the building 

for purposes other than the designated emergency exit use.

(D) Except as specified in ¶¶ (B) and (E) of this section, if the windows or doors 

of a FOOD ESTABLISHMENT, or of a larger structure within which a FOOD

ESTABLISHMENT is located, are kept open for ventilation or other purposes or a 

TEMPORARY FOOD ESTABLISHMENT is not provided with windows and doors as

specified under ¶ (A) of this section, the openings shall be protected against the 

entry of insects and rodents by: 

(1) 16 mesh to 25.4 mm (16 mesh to 1 inch) screens;

(2) Properly designed and installed air curtains to control flying insects; or

(3) Other effective means. 
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Chapter 6 - 5

(E) Paragraph (D) of this section does not apply if flying insects and other pests 

are absent due to the location of the establishment, the weather, or other limiting 

condition.

6-202.16 Exterior Walls and Roofs, Protective Barrier.

Perimeter walls and roofs of a FOOD ESTABLISHMENT shall effectively protect the 

establishment from the weather and the entry of insects, rodents, and other 

animals.

6-202.17 Outdoor Food Vending Areas, Overhead Protection.

Except for machines that vend canned BEVERAGES, if located outside, a machine 

used to vend FOOD shall be provided with overhead protection. 

6-202.18 Outdoor Servicing Areas, Overhead Protection.

Except for areas used only for the loading of water or the discharge of sewage 

and other liquid waste, through the use of a closed system of hoses, SERVICING 

AREAS shall be provided with overhead protection. 

6-202.19 Outdoor Walking and Driving Surfaces, Graded to Drain.

Exterior walking and driving surfaces shall be graded to drain. 

6-202.110 Outdoor Refuse Areas, Curbed and Graded to Drain. 

Outdoor REFUSE areas shall be constructed in accordance with LAW and shall be 

curbed and graded to drain to collect and dispose of liquid waste that results from 

the REFUSE and from cleaning the area and waste receptacles.

6-202.111 Private Homes and Living or Sleeping Quarters, Use Prohibition.

A private home, a room used as living or sleeping quarters, or an area directly 

opening into a room used as living or sleeping quarters may not be used for 

conducting FOOD ESTABLISHMENT operations. P

6-202.112 Living or Sleeping Quarters, Separation.

Living or sleeping quarters located on the PREMISES of a FOOD ESTABLISHMENT

such as those provided for lodging registration clerks or resident managers shall 

be separated from rooms and areas used for FOOD ESTABLISHMENT operations by 

complete partitioning and solid self-closing doors.

6-3 Numbers and Capacities

6-301 Handwashing Sinks

6-301.10 Minimum Number.

HANDWASHING SINKS shall be provided as specified under § 5-203.11. 

6-301.11 Handwashing Cleanser, Availability.

Each HANDWASHING SINK or group of 2 adjacent HANDWASHING SINKS shall be 

provided with a supply of hand cleaning liquid, powder, or bar soap.Pf
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Chapter 6 - 6

6-301.12 Hand Drying Provision.

Each HANDWASHING SINK or group of adjacent HANDWASHING SINKS shall be 

provided with: 

(A) Individual, disposable towels; Pf

(B) A continuous towel system that supplies the user with a clean towel; Pf

or

(C) A heated-air hand drying device; Pf or

(D) A hand drying device that employs an air-knife system that delivers 

high velocity, pressurized air at ambient temperatures. Pf

6-301.13 Handwashing Aids and Devices, Use Restrictions.

A sink used for FOOD preparation or UTENSIL washing, or a service sink or curbed 

cleaning facility used for the disposal of mop water or similar wastes, may not be 

provided with the handwashing aids and devices required for a HANDWASHING 

SINK as specified under §§ 6-301.11 and 6-301.12 and ¶ 5-501.16(C). 

6-301.14 Handwashing Signage.

A sign or poster that notifies FOOD EMPLOYEES to wash their hands shall be 

provided at all HANDWASHING SINKS used by FOOD EMPLOYEES and shall be clearly 

visible to FOOD EMPLOYEES. 

6-301.20 Disposable Towels, Waste Receptacle.

A HANDWASHING SINK or group of adjacent HANDWASHING SINKS that is provided 

with disposable towels shall be provided with a waste receptacle as specified 

under ¶ 5-501.16(C). 

6-302 Toilets and Urinals

6-302.10 Minimum Number.

Toilets and urinals shall be provided as specified under § 5-203.12.

6-302.11 Toilet Tissue, Availability.

A supply of toilet tissue shall be available at each toilet. Pf

6-303 Lighting

6-303.11 Intensity.

The light intensity shall be: 

(A) At least 108 lux (10 foot candles) at a distance of 75 cm (30 inches) 

above the floor, in walk-in refrigeration units and dry FOOD storage areas 

and in other areas and rooms during periods of cleaning;

(B) At least 215 lux (20 foot candles): 
FDA Food Code 2022 Chapter 6. Physical Facilities

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(1) At a surface where FOOD is provided for CONSUMER self-service 

such as buffets and salad bars or where fresh produce or PACKAGED 

FOODS are sold or offered for consumption,

(2) Inside EQUIPMENT such as reach-in and under-counter 

refrigerators; and

(3) At a distance of 75 cm (30 inches) above the floor in areas used 

for handwashing, WAREWASHING, and EQUIPMENT and UTENSIL

storage, and in toilet rooms; and

(C) At least 540 lux (50 foot candles) at a surface where a FOOD EMPLOYEE

is working with FOOD or working with UTENSILS or EQUIPMENT such as 

knives, slicers, grinders, or saws where EMPLOYEE safety is a factor. 

6-304 Ventilation

6-304.11 Mechanical.

If necessary to keep rooms free of excessive heat, steam, condensation, vapors, 

obnoxious odors, smoke, and fumes, mechanical ventilation of sufficient capacity 

shall be provided. 

6-305 Dressing Areas and Lockers

6-305.11 Designation.

(A) Dressing rooms or dressing areas shall be designated if EMPLOYEES routinely 

change their clothes in the establishment. 

(B) Lockers or other suitable facilities shall be provided for the orderly storage of 

EMPLOYEES' clothing and other possessions. 

6-306 Service Sinks

6-306.10 Availability.

A service sink or curbed cleaning facility shall be provided as specified under ¶ 5-

203.13(A).

6-4 Location and Placement

6-401 Handwashing Sinks

6-401.10 Conveniently Located.

HANDWASHING SINKS shall be conveniently located as specified under § 5-204.11. 

6-402 Toilet Rooms

6-402.11 Convenience and Accessibility.

Toilet rooms shall be conveniently located and accessible to EMPLOYEES during 

all hours of operation. 
FDA Food Code 2022 Chapter 6. Physical Facilities

Chapter 6 - 8

6-403 Employee Accommodations

6-403.11 Designated Areas.

(A) Areas designated for EMPLOYEES to eat, drink, and use TOBACCO PRODUCTS

shall be located so that FOOD, EQUIPMENT, LINENS, and SINGLE-SERVICE and 

SINGLE-USE ARTICLES are protected from contamination.

(B) Lockers or other suitable facilities shall be located in a designated room or 

area where contamination of FOOD, EQUIPMENT, UTENSILS, LINENS, and SINGLESERVICE and SINGLE-USE ARTICLES can not occur.

6-404 Distressed Merchandise

6-404.11 Segregation and Location.

Products that are held by the PERMIT HOLDER for credit, redemption, or return to 

the distributor, such as damaged, spoiled, or recalled products, shall be 

segregated and held in designated areas that are separated from FOOD, 

EQUIPMENT, UTENSILS, LINENS, and SINGLE-SERVICE and SINGLE-USE ARTICLES.

Pf

6-405 Refuse, Recyclables, and Returnables

6-405.10 Receptacles, Waste Handling Units, and Designated Storage Areas.

Units, receptacles, and areas designated for storage of REFUSE and recyclable 

and returnable containers shall be located as specified under § 5-501.19. 

6-5 Maintenance and Operation

6-501 Premises, Structures, Attachments, and Fixtures - Methods

6-501.11 Repairing.

PHYSICAL FACILITIES shall be maintained in good repair. 

6-501.12 Cleaning, Frequency and Restrictions.

(A) PHYSICAL FACILITIES shall be cleaned as often as necessary to keep them 

clean.

(B) Except for cleaning that is necessary due to a spill or other accident, cleaning 

shall be done during periods when the least amount of FOOD is exposed such as 

after closing. 

6-501.13 Cleaning Floors, Dustless Methods.

(A) Except as specified in ¶ (B) of this section, only dustless methods of cleaning 

shall be used, such as wet cleaning, vacuum cleaning, mopping with treated dust 

mops, or sweeping using a broom and dust-arresting compounds. 

(B) Spills or drippage on floors that occur between normal floor cleaning times 

may be cleaned:

(1) Without the use of dust-arresting compounds; and
FDA Food Code 2022 Chapter 6. Physical Facilities

Chapter 6 - 9

(2) In the case of liquid spills or drippage, with the use of a small amount 

of absorbent compound such as sawdust or diatomaceous earth applied 

immediately before spot cleaning.

6-501.14 Cleaning Ventilation Systems, Nuisance and Discharge 

Prohibition.

(A) Intake and exhaust air ducts shall be cleaned and filters changed so they are 

not a source of contamination by dust, dirt, and other materials. 

(B) If vented to the outside, ventilation systems may not create a public health 

HAZARD or nuisance or unLAWful discharge. 

6-501.15 Cleaning Maintenance Tools, Preventing Contamination.

FOOD preparation sinks, HANDWASHING SINKS, and WAREWASHING EQUIPMENT may 

not be used for the cleaning of maintenance tools, the preparation or holding of 

maintenance materials, or the disposal of mop water and similar liquid wastes. Pf

6-501.16 Drying Mops.

After use, mops shall be placed in a position that allows them to air-dry without 

soiling walls, EQUIPMENT, or supplies. 

6-501.17 Absorbent Materials on Floors, Use Limitation.

Except as specified in ¶ 6-501.13(B), sawdust, wood shavings, granular salt, 

baked clay, diatomaceous earth, or similar materials may not be used on floors. 

6-501.18 Cleaning of Plumbing Fixtures. 

PLUMBING FIXTURES such as HANDWASHING SINKS, toilets, and urinals shall be 

cleaned as often as necessary to keep them clean.

6-501.19 Closing Toilet Room Doors.

Except during cleaning and maintenance operations, toilet room doors as 

specified under § 6-202.14 shall be kept closed. 

6-501.110 Using Dressing Rooms and Lockers.

(A) Dressing rooms shall be used by EMPLOYEES if the EMPLOYEES regularly 

change their clothes in the establishment. 

(B) Lockers or other suitable facilities shall be used for the orderly storage of 

EMPLOYEE clothing and other possessions. 

6-501.111 Controlling Pests.

The PREMISES shall be maintained free of insects, rodents, and other pests. The 

presence of insects, rodents, and other pests shall be controlled to eliminate their 

presence on the PREMISES by:

(A) Routinely inspecting incoming shipments of FOOD and supplies;

(B) Routinely inspecting the PREMISES for evidence of pests;
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Chapter 6 - 10

(C) Using methods, if pests are found, such as trapping devices or other 

means of pest control as specified under §§ 7-202.12, 7-206.12, and 

7-206.13; Pf and

(D) Eliminating harborage conditions.

6-501.112 Removing Dead or Trapped Birds, Insects, Rodents, and Other 

Pests.

Dead or trapped birds, insects, rodents, and other pests shall be removed from 

control devices and the PREMISES at a frequency that prevents their accumulation, 

decomposition, or the attraction of pests. 

6-501.113 Storing Maintenance Tools.

Maintenance tools such as brooms, mops, vacuum cleaners, and similar items 

shall be: 

(A) Stored so they do not contaminate FOOD, EQUIPMENT, UTENSILS, LINENS, and 

SINGLE-SERVICE and SINGLE-USE ARTICLES; and

(B) Stored in an orderly manner that facilitates cleaning the area used for storing 

the maintenance tools. 

6-501.114 Maintaining Premises, Unnecessary Items and Litter. 

The PREMISES shall be free of: 

(A) Items that are unnecessary to the operation or maintenance of the 

establishment such as EQUIPMENT that is nonfunctional or no longer used; 

and

(B) Litter. 

6-501.115 Prohibiting Animals.

(A) Except as specified in ¶¶ (B), (C) and (D) of this section, live animals may not 

be allowed on the PREMISES of a FOOD ESTABLISHMENT. Pf

(B) Live animals may be allowed in the following situations if the contamination of 

FOOD; clean EQUIPMENT, UTENSILS, and LINENS; and unwrapped SINGLE-SERVICE

and SINGLE-USE ARTICLES can not result:

(1) Edible fish or decorative fish in aquariums, shellfish or crustacea on ice 

or under refrigeration, and shellfish and crustacea in display tank systems;

(2) Patrol dogs accompanying police or security officers in offices and 

dining, sales, and storage areas, and sentry dogs running loose in outside 

fenced areas;

(3) In areas that are not used for food preparation and that are usually 

open for customers, such as dining and sales areas, service animals that 

are controlled by the disabled employee or person, if a health or safety 

hazard will not result from the presence or activities of the service animal;
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Chapter 6 - 11

(4) Pets in the common dining areas of institutional care facilities such as 

nursing homes, assisted living facilities, group homes, or residential care 

facilities at times other than during meals if:

(a) Effective partitioning and self-closing doors separate the 

common dining areas from FOOD storage or FOOD preparation areas,

(b) Condiments, EQUIPMENT, and UTENSILS are stored in enclosed 

cabinets or removed from the common dining areas when pets are 

present, and

(c) Dining areas including tables, countertops, and similar surfaces 

are effectively cleaned before the next meal service; and

(5) In areas that are not used for FOOD preparation, storage, sales, display, 

or dining, in which there are caged animals or animals that are similarly 

confined, such as in a variety store that sells pets or a tourist park that 

displays animals. 

(C) Live or dead fish bait may be stored if contamination of FOOD; clean 

EQUIPMENT, UTENSILS, and LINENS; and unwrapped SINGLE-SERVICE and SINGLEUSE ARTICLES can not result.

(D) If APPROVED by the REGULATORY AUTHORITY, FOOD ESTABLISHMENTS may allow 

pet dogs in outdoor dining areas.
FDA Food Code 2022 Chapter 8. Compliance and Enforcement

Chapter 7 - 1

Chapter 7 Poisonous or 

Toxic Materials

Parts:

7-1 Labeling and Identification

7-2 Operational Supplies and Applications

7-3 Stock and Retail Sale

7-1 Labeling and Identification

7-1 Labeling and Identification

7-101 Original Containers

7-101.11 Identifying Information, Prominence.

Containers of POISONOUS OR TOXIC MATERIALS and PERSONAL CARE ITEMS shall bear 

a legible manufacturer's label. Pf

7-102 Working Containers

7-102.11 Common Name.

Working containers used for storing POISONOUS OR TOXIC MATERIALS such as 

cleaners and SANITIZERS taken from bulk supplies shall be clearly and individually 

identified with the common name of the material. Pf

7-2 Operational Supplies and Applications

7-201 Storage

7-201.11 Separation. 

Poisonous or toxic materials shall be stored so they can not contaminate food, 

equipment, utensils, linens, and single-service and single-use articles by: 

(A) Separating the POISONOUS OR TOXIC MATERIALS by spacing or 

partitioning; P and

(B) Locating the POISONOUS OR TOXIC MATERIALS in an area that is not 

above FOOD, EQUIPMENT, UTENSILS, LINENS, and SINGLE-SERVICE or SINGLEUSE ARTICLES. This paragraph does not apply to EQUIPMENT and UTENSIL

cleaners and SANITIZERS that are stored in WAREWASHING areas for 

availability and convenience if the materials are stored to prevent 

contamination of FOOD, EQUIPMENT, UTENSILS, LINENS, and SINGLE-SERVICE

and SINGLE-USE ARTICLES. P
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Chapter 7 - 2

7-202 Presence and Use

7-202.11 Restriction.

(A) Only those POISONOUS OR TOXIC MATERIALS that are required for the operation 

and maintenance of a FOOD ESTABLISHMENT, such as for the cleaning and 

SANITIZING of EQUIPMENT and UTENSILS and the control of insects and rodents, 

shall be allowed in a FOOD ESTABLISHMENT. Pf

(B) Paragraph (A) of this section does not apply to PACKAGED POISONOUS OR TOXIC 

MATERIALS that are for retail sale. 

7-202.12 Conditions of Use.

POISONOUS OR TOXIC MATERIALS shall be: 

(A) Used according to: 

(1) LAW and this Code,

(2) Manufacturer's use directions included in labeling, and, for a 

pesticide, manufacturer's label instructions that state that use is 

allowed in a FOOD ESTABLISHMENT, P

(3) The conditions of certification, if certification is required, for use 

of the pest control materials, P and

(4) Additional conditions that may be established by the 

REGULATORY AUTHORITY; and

(B) Applied so that: 

(1) A HAZARD to EMPLOYEES or other PERSONS is not constituted, P

and

(2) Contamination including toxic residues due to drip, drain, fog, 

splash or spray on FOOD, EQUIPMENT, UTENSILS, LINENS, and SINGLESERVICE and SINGLE-USE ARTICLES is prevented, and this is achieved 

by: P

(a) Removing the items, P

(b) Covering the items with impermeable covers, P or

(c) Taking other appropriate preventive actions, P and

(d) Cleaning and SANITIZING EQUIPMENT and UTENSILS after 

the application. P

(C) A restricted USE PESTICIDE shall be applied only by an applicator 

certified as defined in 7 USC 136 Definitions, (e) Certified Applicator, of 

the Federal Insecticide, Fungicide, and Rodenticide Act, or a PERSON

under the direct supervision of a certified applicator. Pf
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Chapter 7 - 3

7-203 Container Prohibitions

7-203.11 Poisonous or Toxic Material Containers.

A container previously used to store POISONOUS OR TOXIC MATERIALS may not be 

used to store, transport, or dispense FOOD, EQUIPMENT, UTENSILS, LINENS, SINGLESERVICE or SINGLE-USE ARTICLES . P

7-204 Chemicals

7-204.11 Sanitizers, Criteria. 

Chemical SANITIZERS, including chemical sanitizing solutions generated on-site, 

and other chemical antimicrobials applied to FOOD-CONTACT SURFACEs shall:

(A) Meet the requirements specified in 40 CFR 180.940 Tolerance 

exemptions for active and inert ingredients for use in antimicrobial 

formulations (Food-contact surface sanitizing solutions)P, or

(B) Meet the requirements as specified in 40 CFR 180.2020 Pesticide 

Chemicals Not Requiring a Tolerance or Exemption from Tolerance-Nonfood determinations.P

7-204.12 Chemicals for Washing, Treatment, Storage and Processing 

Fruits and Vegetables, Criteria.

Chemicals, including those generated on-site, used to wash or peel raw, whole 

fruits and vegetables or used in the treatment, storage, and processing of fruits 

and vegetables shall:

(A) Be an approved food additive listed for this intended use in 21 CFR 

173, P or

(B) Be generally recognized as safe (GRAS) for this intended use, P or

(C) Be the subject of an effective food contact notification for this intended 

use (only effective for the manufacturer or supplier identified in the 

notification), P and

(D) Meet the requirements in 40 CFR 156 Labeling Requirements for 

Pesticide and Devices. P

7-204.13 Boiler Water Additives, Criteria.

Chemicals used as boiler water ADDITIVES shall meet the requirements specified 

in 21 CFR 173.310 Boiler water additives. P

7-204.14 Drying Agents, Criteria.

Drying agents used in conjunction with SANITIZATION shall:

(A) Contain only components that are listed as one of the following:
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Chapter 7 - 4

(1) Generally recognized as safe for use in FOOD as specified in 21 CFR 

182 - Substances Generally Recognized as Safe, or 21 CFR 184 - Direct 

Food Substances Affirmed as Generally Recognized as Safe, P

(2) Generally recognized as safe for the intended use as specified in 21 

CFR 186 - Indirect Food Substances Affirmed as Generally Recognized 

as Safe, P

(3) Generally recognized as safe for the intended use as determined by 

experts qualified in scientific training and experience to evaluate the safety 

of substances added, directly or indirectly, to FOOD as described in 21 CFR 

170.30 Eligibility for classification as generally recognized as safe 

(GRAS),P

(4) Subject of an effective Food Contact Notification as described in the 

Federal Food Drug and Cosmetic Act (FFDCA) Section 409(h),P

(5) APPROVED for use as a drying agent under a prior sanction as 

described in the Federal Food Drug and Cosmetic Act (FFDCA) §

201(s)(4); P

(6) Specifically regulated as an indirect FOOD ADDITIVE for use as a drying 

agent as specified in 21 CFR Parts 174-178, P or

(7) APPROVED for use as a drying agent under the threshold of regulation 

process established by 21 CFR 170.39 Threshold of regulation for 

substances used in food-contact articles; P and

(B) When SANITIZATION is with chemicals, the approval required under 

Subparagraph (A)(5) or (A)(7) of this section or the regulation as an indirect FOOD

ADDITIVE required under Subparagraph (A)(6) of this section, shall be specifically 

for use with chemical SANITIZING solutions. P

7-205 Lubricants

7-205.11 Incidental Food Contact, Criteria.

Lubricants shall meet the requirements specified in 21 CFR 178.3570 Lubricants 

with incidental food contact, if they are used on FOOD-CONTACT SURFACES, on 

bearings and gears located on or within FOOD-CONTACT SURFACES, or on bearings 

and gears that are located so that lubricants may leak, drip, or be forced into 

FOOD or onto FOOD-CONTACT SURFACES. P

7-206 Pesticides

7-206.11 Restricted Use Pesticides, Criteria. 

RESTRICTED USE PESTICIDES specified under ¶ 7-202.12(C) shall meet the 

requirements specified in 40 CFR 152 Subpart I - Classification of Pesticides. P

7-206.12 Rodent Bait Stations.

Rodent bait shall be contained in a covered, tamper-resistant bait station. P
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Chapter 7 - 5

7-206.13 Tracking Powders, Pest Control and Monitoring.

(A) Except as specified in ¶ (B) of this section, a tracking powder pesticide may 

not be used in a FOOD ESTABLISHMENT. P

(B) If used, a nontoxic tracking powder such as talcum or flour may not 

contaminate FOOD, EQUIPMENT, UTENSILS, LINENS, and SINGLE-SERVICE and SINGLEUSE ARTICLES.

7-207 Medicines

7-207.11 Restriction and Storage.

(A) Except for medicines that are stored or displayed for retail sale, only those 

medicines that are necessary for the health of EMPLOYEES shall be allowed in a 

FOOD ESTABLISHMENT. Pf

(B) Medicines that are in a FOOD ESTABLISHMENT for the EMPLOYEES' use shall be 

labeled as specified under § 7-101.11 and located to prevent the contamination 

of FOOD, EQUIPMENT, UTENSILS, LINENS, and SINGLE-SERVICE and SINGLE-USE 

ARTICLES.

P

7-207.12 Refrigerated Medicines, Storage.

Medicines belonging to EMPLOYEES or to children in a day care center that require 

refrigeration and are stored in a FOOD refrigerator shall be: 

(A) Stored in a package or container and kept inside a covered, leakproof 

container that is identified as a container for the storage of medicines; P and

(B) Located so they are inaccessible to children. P

7-208 First Aid Supplies

7-208.11 Storage.

First aid supplies that are in a FOOD ESTABLISHMENT for the EMPLOYEES' use shall 

be: 

(A) Labeled as specified under § 7-101.11; Pf and

(B) Stored in a kit or a container that is located to prevent the 

contamination of FOOD, EQUIPMENT, UTENSILS, and LINENS, and SINGLESERVICE and SINGLE-USE ARTICLES. P

7-209 Other Personal Care Items

7-209.11 Storage.

Except as specified under §§ 7-207.12 and 7-208.11, EMPLOYEES shall store their 

PERSONAL CARE ITEMS in facilities as specified under ¶ 6-305.11(B).

7-3 Stock and Retail Sale
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Storage and Display

7-301.11 Separation.

POISONOUS or TOXIC MATERIALS shall be stored and displayed for retail sale so 

they can not contaminate FOOD, EQUIPMENT, UTENSILS, LINENS, and SINGLESERVICE and SINGLE-USE ARTICLES by: 

(A) Separating the POISONOUS or TOXIC MATERIALS by spacing or 

partitioning; P and

(B) Locating the POISONOUS OR TOXIC MATERIALS in an area that is not 

above FOOD, EQUIPMENT, UTENSILS, LINENS, and SINGLE-SERVICE or SINGLEUSE ARTICLES.

 P 
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Chapter 8 - 1

Chapter 8 Compliance and 

Enforcement

Parts:

8-1 Code Applicability

8-2 Plan Submission and Approval

8-3 Permit to Operate

8-4 Inspection and Correction of Violations

8-5 Prevention of Foodborne Disease Transmission By Employees

8-1 Code Applicability

8-101 Use for Intended Purpose

8-101.10 Public Health Protection.

(A) The REGULATORY AUTHORITY shall apply this Code to promote its underlying 

purpose, as specified in § 1-102.10, of safeguarding public health and ensuring 

that FOOD is safe, unADULTERATED, and honestly presented when offered to the 

CONSUMER or donated. 

(B) In enforcing the provisions of this Code, the REGULATORY AUTHORITY shall 

assess existing facilities or EQUIPMENT that were in use before the effective date 

of this Code based on the following considerations: 

(1) Whether the facilities or EQUIPMENT are in good repair and capable of 

being maintained in a sanitary condition; 

(2) Whether FOOD-CONTACT SURFACES comply with Subpart 4-101;

(3) Whether the capacities of cooling, heating, and holding EQUIPMENT are 

sufficient to comply with § 4-301.11; and

(4) The existence of a documented agreement with the PERMIT HOLDER that 

the facilities or EQUIPMENT will be replaced as specified under 

¶ 8-304.11(G). 

8-102 Additional Requirements

8-102.10 Preventing Health Hazards, Provision for Conditions Not 

Addressed.

(A) If necessary to protect against public health HAZARDS or nuisances, the 

REGULATORY AUTHORITY may impose specific requirements in addition to the 

requirements contained in this Code that are authorized by LAW. 
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(B) The REGULATORY AUTHORITY shall document the conditions that necessitate 

the imposition of additional requirements and the underlying public health 

rationale. The documentation shall be provided to the PERMIT applicant or PERMIT 

HOLDER and a copy shall be maintained in the REGULATORY AUTHORITY’S file for 

the FOOD ESTABLISHMENT. 

8-103 Variances

8-103.10 Modifications and Waivers.

The REGULATORY AUTHORITY may grant a VARIANCE by modifying or waiving the 

requirements of this Code if in the opinion of the REGULATORY AUTHORITY a health 

HAZARD or nuisance will not result from the VARIANCE. If a VARIANCE is granted, the 

REGULATORY AUTHORITY shall retain the information specified under § 8-103.11 in 

its records for the FOOD ESTABLISHMENT. 

8-103.11 Documentation of Proposed Variance and Justification.

Before a VARIANCE from a requirement of this Code is APPROVED, the information 

that shall be provided by the PERSON requesting the VARIANCE and retained in the 

REGULATORY AUTHORITY'S file on the FOOD ESTABLISHMENT includes:

(A) A statement of the proposed VARIANCE of the Code requirement citing 

relevant Code section numbers;Pf

(B) An analysis of the rationale for how the potential public health HAZARDS

and nuisances addressed by the relevant Code sections will be 

alternatively addressed by the proposal; Pf and

(C) A HACCP PLAN if required as specified under ¶ 8-201.13(A) that 

includes the information specified under § 8-201.14 as it is relevant to the 

VARIANCE requested. Pf

8-103.12 Conformance with Approved Procedures.

If the REGULATORY AUTHORITY grants a VARIANCE as specified in § 8-103.10, or a 

HACCP PLAN is otherwise required as specified under § 8-201.13, the PERMIT 

HOLDER shall: 

(A) Maintain the approved variance at the food establishment; Pf and

(B) Comply with the HACCP plans and procedures that are submitted as 

specified under § 8-201.14 and approved as a basis for the modification or 

waiver; P and

(C) Maintain and provide to the regulatory authority, upon request, records 

specified under § 8-201.14 (D) and (E)(3) that demonstrate that the 

following are routinely employed;

(1) Procedures for monitoring the CRITICAL CONTROL POINTS, Pf

(2) Monitoring of the CRITICAL CONTROL POINTS, Pf

(3) Verification of the effectiveness of the operation or process, Pf

and
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(4) Necessary corrective actions if there is failure at a CRITICAL 

CONTROL POINT. Pf

8-2 Plan Submission and Approval

8-201 Facility and Operating Plans

8-201.11 When Plans Are Required.

A PERMIT applicant or PERMIT HOLDER shall submit to the REGULATORY AUTHORITY

properly prepared plans and specifications for review and approval before: 

(A) The construction of a FOOD ESTABLISHMENT; Pf

(B) The conversion of an existing structure for use as a FOOD

ESTABLISHMENT; Pf or

(C) The remodeling of a FOOD ESTABLISHMENT or a change of type of FOOD

ESTABLISHMENT or FOOD operation as specified under ¶ 8-302.14(C) if the 

REGULATORY AUTHORITY determines that plans and specifications are 

necessary to ensure compliance with this Code. Pf

8-201.12 Contents of the Plans and Specifications.

The plans and specifications for a FOOD ESTABLISHMENT, including a FOOD

ESTABLISHMENT specified under § 8-201.13, shall include, as required by the 

REGULATORY AUTHORITY based on the type of operation, type of FOOD preparation, 

and FOODS prepared, the following information to demonstrate conformance with 

Code provisions: 

(A) Intended menu;

(B) Anticipated volume of FOOD to be stored, prepared, and sold or served;

(C) Proposed layout, mechanical schematics, construction materials, and 

finish schedules;

(D) Proposed EQUIPMENT types, manufacturers, model numbers, locations, 

dimensions, performance capacities, and installation specifications;

(E) Evidence that standard procedures that ensure compliance with the 

requirements of this Code are developed or are being developed; and

(F) Other information that may be required by the REGULATORY AUTHORITY

for the proper review of the proposed construction, conversion or 

modification, and procedures for operating a FOOD ESTABLISHMENT.

8-201.13 When a HACCP Plan is Required.

(A) Before engaging in an activity that requires a HACCP PLAN, a PERMIT

applicant or PERMIT HOLDER shall submit to the REGULATORY AUTHORITY for 

approval a properly prepared HACCP PLAN as specified under § 8-201.14 and the 

relevant provisions of this Code if: 

(1) Submission of a HACCP PLAN is required according to LAW;
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(2) A VARIANCE is required as specified under Subparagraph 3-

401.11(D)(4), § 3-502.11, or ¶ 4-204.110(B);

(3) The REGULATORY AUTHORITY determines that a FOOD preparation or 

processing method requires a VARIANCE based on a plan submittal 

specified under § 8-201.12, an inspectional finding, or a VARIANCE request. 

(B) Before engaging in REDUCED OXYGEN PACKAGING without a VARIANCE as 

specified under § 3-502.12, a PERMIT applicant or PERMIT HOLDER shall submit a 

properly prepared HACCP PLAN to the REGULATORY AUTHORITY.

8-201.14 Contents of a HACCP Plan.

For a food establishment that is required under § 8-201.13 to have a HACCP

PLAN, the PERMIT applicant or PERMIT HOLDER shall submit to the REGULATORY 

AUTHORITY a properly prepared HACCP PLAN that includes:

(A) General information such as the name of the PERMIT applicant or 

PERMIT HOLDER, the FOOD ESTABLISHMENT address, and contact information;

(B) A categorization of the types of TIME/TEMPERATURE CONTROL FOR 

SAFETY FOODS that are to be controlled under the HACCP PLAN;

Pf

(C) A flow diagram or chart for each specific FOOD or category type that 

identifies:

(1) Each step in the process; Pf and

(2) The steps that are CRITICAL CONTROL POINTS; Pf

(D) The ingredients, recipes or formulations, materials and equipment

used in the preparation of each specific FOOD or category type and 

methods and procedural control measures that address the FOOD safety 

concerns involved; Pf

(E) A CRITICAL CONTROL POINTS summary for each specific FOOD or 

category type that clearly identifies:

(1) Each CRITICAL CONTROL POINT, Pf

(2) The significant HAZARDS for each CRITICAL CONTROL POINT, Pf

(3) The CRITICAL LIMITS for each CRITICAL CONTROL POINT, Pf

(4) The method and frequency for monitoring and controlling each 

CRITICAL CONTROL POINT by the designated FOOD EMPLOYEE or the 

PERSON IN CHARGE, Pf

(5) Action to be taken by the designated FOOD EMPLOYEE or PERSON 

IN CHARGE if the CRITICAL LIMITS for each CRITICAL CONTROL POINT are 

not met, Pf

(6) The method and frequency for the PERSON IN CHARGE to routinely 

verify that the FOOD EMPLOYEE is following standard operating 

procedures and monitoring CRITICAL CONTROL POINTS, Pf and
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(7) Records to be maintained by the PERSON IN CHARGE to 

demonstrate that the HACCP PLAN is properly operated and 

managed; Pf

(F) Supporting documents such as:

(1) FOOD EMPLOYEE and supervisory training plan that addresses the 

FOOD safety issues of concern; Pf

(2) Copies of blank records forms that are necessary to implement 

the HACCP PLAN; Pf

(3) Additional scientific data or other information, as required by the 

REGULATORY AUTHORITY, supporting the determination that FOOD

safety is not compromised by the proposal. Pf

(G) Any other information required by the REGULATORY AUTHORITY.

8-202 Confidentiality

8-202.10 Trade Secrets. 

The REGULATORY AUTHORITY shall treat as confidential in accordance with LAW, 

information that meets the criteria specified in LAW for a trade secret and is 

contained on inspection report forms and in the plans and specifications 

submitted as specified under §§ 8-201.12 and 8-201.14.

8-203 Construction Inspection and Approval

8-203.10 Preoperational Inspections.

The REGULATORY AUTHORITY shall conduct one or more preoperational inspections 

to verify that the FOOD ESTABLISHMENT is constructed and equipped in accordance 

with the APPROVED plans and APPROVED modifications of those plans, has 

established standard operating procedures as specified under ¶ 8-201.12(E), and 

is in compliance with LAW and this Code.

8-3 Permit to Operate

8-301 Requirement

8-301.11 Prerequisite for Operation.

A PERSON may not operate a FOOD ESTABLISHMENT without a valid PERMIT to 

operate issued by the REGULATORY AUTHORITY. Pf

8-302 Application Procedure

8-302.11 Submission 30 Calendar Days Before Proposed Opening.

An applicant shall submit an application for a PERMIT at least 30 calendar days 

before the date planned for opening a FOOD ESTABLISHMENT or the expiration date 

of the current PERMIT for an existing facility.
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8-302.12 Form of Submission.

A PERSON desiring to operate a FOOD ESTABLISHMENT shall submit to the 

REGULATORY AUTHORITY a written application for a PERMIT on a form provided by 

the REGULATORY AUTHORITY. 

8-302.13 Qualifications and Responsibilities of Applicants. 

To qualify for a PERMIT, an applicant shall: 

(A) Be an owner of the FOOD ESTABLISHMENT or an officer of the legal 

ownership;

(B) Comply with the requirements of this Code;

(C) As specified under § 8-402.11, agree to allow access to the FOOD

ESTABLISHMENT and to provide required information; and

(D) Pay the applicable PERMIT fees at the time the application is submitted.

8-302.14 Contents of the Application.

The application shall include: 

(A) The name, birth date, mailing address, telephone number, and 

signature of the PERSON applying for the PERMIT and the name, mailing 

address, and location of the FOOD ESTABLISHMENT;

(B) Information specifying whether the FOOD ESTABLISHMENT is owned by 

an association, corporation, individual, partnership, or other legal entity;

(C) A statement specifying whether the FOOD ESTABLISHMENT:

(1) Is mobile or stationary and temporary or permanent, and

(2) Is an operation that includes one or more of the following:

(a) Prepares, offers for sale, or serves TIME/TEMPERATURE 

CONTROL FOR SAFETY FOOD:

(i) Only to order upon a consumer's request,

(ii) In advance in quantities based on projected 

consumer demand and discards food that is not sold 

or served at an approved frequency, or

(iii) Using time as the public health control as 

specified under § 3-501.19,

(b) Prepares TIME/TEMPERATURE CONTROL FOR SAFETY FOOD in 

advance using a FOOD preparation method that involves two 

or more steps which may include combining 

TIME/TEMPERATURE CONTROL FOR SAFETY FOOD ingredients; 

cooking; cooling; reheating; hot or cold holding; freezing; or 

thawing,

(c) Prepares FOOD as specified under Subparagraph 

(C)(2)(b) of this section for delivery to and consumption at a 
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location off the PREMISES of the FOOD ESTABLISHMENT where it 

is prepared,

(d) Prepares FOOD as specified under Subparagraph 

(C)(2)(b) of this section for service to a HIGHLY SUSCEPTIBLE 

POPULATION,

(e) Prepares only food that is not time/temperature control of 

safety food, or

(f) Does not prepare, but offers for sale only prePACKAGED

FOOD that is not TIME/TEMPERATURE CONTROL FOR SAFETY 

FOOD;

(D) The name, title, address, and telephone number of the PERSON

directly responsible for the FOOD ESTABLISHMENT;

(E) The name, title, address, and telephone number of the PERSON

who functions as the immediate supervisor of the PERSON specified 

under ¶ (D) of this section such as the zone, district, or regional 

supervisor;

(F) The names, titles, and addresses of: 

(1) The PERSONS comprising the legal ownership as specified 

under ¶ (B) of this section including the owners and officers, 

and

(2) The local resident agent if one is required based on the 

type of legal ownership;

(G) A statement signed by the applicant that: 

(1) Attests to the accuracy of the information provided in the 

application, and

(2) Affirms that the applicant will:

(a) Comply with this Code, and

(b) Allow the REGULATORY AUTHORITY access to the 

establishment as specified under § 8-402.11 and to 

the records specified under §§ 3-203.12 and 5-205.13 

and Subparagraph 8-201.14(D)(6); and

(H) Other information required by the REGULATORY AUTHORITY. 

8-303 Issuance

8-303.10 New, Converted, or Remodeled Establishments.

For FOOD ESTABLISHMENTS that are required to submit plans as specified under § 

8-201.11 the REGULATORY AUTHORITY shall issue a PERMIT to the applicant after: 

(A) A properly completed application is submitted;

(B) The required fee is submitted;
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(C) The required plans, specifications, and information are reviewed and 

APPROVED; and

(D) A preoperational inspection as specified in § 8-203.10 shows that the 

establishment is built or remodeled in accordance with the APPROVED

plans and specifications and that the establishment is in compliance with 

this Code.

8-303.20 Existing Establishments, Permit Renewal, and Change of 

Ownership.

The REGULATORY AUTHORITY may renew a PERMIT for an existing FOOD

ESTABLISHMENT or may issue a PERMIT to a new owner of an existing FOOD

ESTABLISHMENT after a properly completed application is submitted, reviewed, and 

APPROVED, the fees are paid, and an inspection shows that the establishment is 

in compliance with this Code. 

8-303.30 Denial of Application for Permit, Notice.

If an application for a PERMIT to operate is denied, the REGULATORY AUTHORITY

shall provide the applicant with a notice that includes: 

(A) The specific reasons and Code citations for the PERMIT denial;

(B) The actions, if any, that the applicant must take to qualify for a PERMIT; 

and 

(C) Advisement of the applicant's right of appeal and the process and time 

frames for appeal that are provided in LAW.

8-304 Conditions of Retention

8-304.10 Responsibilities of the Regulatory Authority.

(A) At the time a PERMIT is first issued, the REGULATORY AUTHORITY shall provide 

to the PERMIT HOLDER a copy of this Code so that the PERMIT HOLDER is notified of 

the compliance requirements and the conditions of retention, as specified under 

§ 8-304.11, that are applicable to the PERMIT. 

(B) Failure to provide the information specified in ¶ (A) of this section does not 

prevent the REGULATORY AUTHORITY from taking authorized action or seeking 

remedies if the PERMIT HOLDER fails to comply with this Code or an order, 

warning, or directive of the REGULATORY AUTHORITY.

8-304.11 Responsibilities of the Permit Holder.

Upon acceptance of the PERMIT issued by the REGULATORY AUTHORITY, the PERMIT 

HOLDER in order to retain the PERMIT shall: 

(A) Post the PERMIT in a location in the FOOD ESTABLISHMENT that is 

conspicuous to CONSUMERS;

(B) Comply with the provisions of this Code including the conditions of a 

granted VARIANCE as specified under § 8-103.12, and APPROVED plans as 

specified under § 8-201.12;
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(C) If a FOOD ESTABLISHMENT is required under § 8-201.13 to operate under 

a HACCP PLAN, comply with the plan as specified under § 8-103.12;

(D) Immediately contact the REGULATORY AUTHORITY to report an illness of 

a FOOD EMPLOYEE or CONDITIONAL EMPLOYEE as specified under 

¶ 2-201.11(B);

(E) Immediately discontinue operations and notify the REGULATORY 

AUTHORITY if an IMMINENT HEALTH HAZARD may exist as specified under 

§ 8-404.11;

(F) Allow representatives of the REGULATORY AUTHORITY access to the 

FOOD ESTABLISHMENT as specified under § 8-402.11;

(G) Replace existing facilities and EQUIPMENT specified in § 8-101.10 with 

facilities and EQUIPMENT that comply with this Code if: 

(1) The REGULATORY AUTHORITY directs the replacement because the 

facilities and EQUIPMENT constitute a public health HAZARD or 

nuisance or no longer comply with the criteria upon which the 

facilities and EQUIPMENT were accepted,

(2) The REGULATORY AUTHORITY directs the replacement of the 

facilities and EQUIPMENT because of a change of ownership, or

(3) The facilities and EQUIPMENT are replaced in the normal course 

of operation;

(H) Comply with directives of the REGULATORY AUTHORITY including time 

frames for corrective actions specified in inspection reports, notices, 

orders, warnings, and other directives issued by the REGULATORY 

AUTHORITY in regard to the PERMIT HOLDER'S FOOD ESTABLISHMENT or in 

response to community emergencies;

(I) Accept notices issued and served by the REGULATORY AUTHORITY

according to LAW; and

(J) Be subject to the administrative, civil, injunctive, and criminal remedies 

authorized in LAW for failure to comply with this Code or a directive of the 

REGULATORY AUTHORITY, including time frames for corrective actions 

specified in inspection reports, notices, orders, warnings, and other 

directives.

(K) Notify customers that a copy of the most recent establishment 

inspection report is available upon request by posting a sign or placard in 

a location in the food establishment that is conspicuous to customers or by 

another method acceptable to the REGULATORY AUTHORITY.

8-304.20 Permits Not Transferable.

A PERMIT may not be transferred from one PERSON to another PERSON, from one 

FOOD ESTABLISHMENT to another, or from one type of operation to another if the 

FOOD operation changes from the type of operation specified in the application as 

specified under ¶ 8-302.14(C) and the change in operation is not APPROVED. 
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8-4 Inspection and Correction of Violations

8-401 Frequency

8-401.10 Establishing Inspection Interval.

(A) Except as specified in ¶¶ (B) and (C) of this section, the REGULATORY 

AUTHORITY shall inspect a FOOD ESTABLISHMENT at least once every 6 months. 

(B) The regulatory authority may increase the interval between inspections 

beyond 6 months if: 

(1) The FOOD ESTABLISHMENT is fully operating under an APPROVED and 

validated HACCP PLAN as specified under § 8-201.14 and ¶¶ 8-103.12(B) 

and (C);

(2) The FOOD ESTABLISHMENT is assigned a less frequent inspection 

frequency based on a written RISK-based inspection schedule that is being 

uniformly applied throughout the jurisdiction and at least once every 6 

months the establishment is contacted by telephone or other means by 

the REGULATORY AUTHORITY to ensure that the establishment manager and 

the nature of FOOD operation are not changed; or

(3) The establishment's operation involves only coffee service and other 

unPACKAGED or prePACKAGED FOOD that is not TIME/TEMPERATURE CONTROL 

FOR SAFETY FOOD such as carbonated BEVERAGES and snack FOOD such as 

chips, nuts, popcorn, and pretzels. 

(C) The REGULATORY AUTHORITY shall periodically inspect throughout its PERMIT

period a TEMPORARY FOOD ESTABLISHMENT that prepares, sells, or serves 

unPACKAGED TIME/TEMPERATURE CONTROL FOR SAFETY FOOD and that: 

(1) Has improvised rather than permanent facilities or EQUIPMENT for 

accomplishing functions such as handwashing, FOOD preparation and 

protection, FOOD temperature control, WAREWASHING, providing DRINKING 

WATER, waste retention and disposal, and insect and rodent control; or

(2) Has inexperienced FOOD EMPLOYEES.

8-401.20 Performance- and Risk-Based.

Within the parameters specified in § 8-401.10, the REGULATORY AUTHORITY shall 

prioritize, and conduct more frequent inspections based upon its assessment of a 

FOOD ESTABLISHMENT'S history of compliance with this Code and the 

establishment's potential as a vector of foodborne illness by evaluating: 

(A) Past performance, for nonconformance with Code or HACCP PLAN

requirements that are PRIORITY ITEMS or PRIORITY FOUNDATION ITEMS;

(B) Past performance, for numerous or repeat violations of Code or 

HACCP PLAN requirements that are CORE ITEMS;

(C) Past performance, for complaints investigated and found to be valid;
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(D) The HAZARDS associated with the particular FOODS that are prepared, 

stored, or served;

(E) The type of operation including the methods and extent of FOOD

storage, preparation, and service;

(F) The number of people served; and

(G) Whether the population served is a HIGHLY SUSCEPTIBLE POPULATION.

8-402 Competency and Access

8-402.10 Competency of Inspectors.

(A) An authorized representative of the REGULATORY AUTHORITY who inspects a 

FOOD ESTABLISHMENT or conducts plan review for compliance with this Code shall 

have knowledge, skills and ability to adequately perform the required duties.

(B) The REGULATORY AUTHORITY shall ensure that authorized representatives who 

inspect a FOOD ESTABLISHMENT or conduct plan review for compliance with this 

Code have access to training and continuing education as needed to properly 

identify violations and apply the Code.

402.11 Allowed at Reasonable Times after Due Notice.

After the REGULATORY AUTHORITY presents official credentials and provides notice 

of the purpose of, and an intent to conduct, an inspection, the PERSON IN CHARGE

shall allow the REGULATORY AUTHORITY to determine if the FOOD ESTABLISHMENT is 

in compliance with this Code by allowing access to the establishment, allowing 

inspection, and providing information and records specified in this Code and to 

which the REGULATORY AUTHORITY is entitled according to LAW, during the FOOD

ESTABLISHMENT'S hours of operation and other reasonable times.

8-402.20 Refusal, Notification of Right to Access, and Final Request for 

Access.

If a person denies access to the regulatory authority, the regulatory authority 

shall: 

(A) Inform the PERSON that:

(1) The permit holder is required to allow access to the regulatory 

authority as specified under § 8-402.11 of this Code,

(2) Access is a condition of the acceptance and retention of a food 

establishment permit to operate as specified under ¶ 8-304.11(F), 

and

(3) If access is denied, an order issued by the appropriate authority 

allowing access, hereinafter referred to as an inspection order, may 

be obtained according to LAW; and

(B) Make a final request for access. 

8-402.30 Refusal, Reporting.
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If after the REGULATORY AUTHORITY presents credentials and provides notice as 

specified under § 8-402.11, explains the authority upon which access is 

requested, and makes a final request for access as specified in § 8-402.20, the 

PERSON IN CHARGE continues to REFUSE access, the REGULATORY AUTHORITY shall 

provide details of the denial of access on an inspection report form. 

8-402.40 Inspection Order to Gain Access.

If denied access to a FOOD ESTABLISHMENT for an authorized purpose and after 

complying with § 8-402.20, the REGULATORY AUTHORITY may issue, or apply for 

the issuance of, an inspection order to gain access as provided in LAW. 

8-403 Report of Findings

8-403.10 Documenting Information and Observations.

The REGULATORY AUTHORITY shall document on an inspection report form: 

(A) Administrative information about the FOOD ESTABLISHMENT'S legal 

identity, street and mailing addresses, type of establishment and operation 

as specified under ¶ 8-302.14(C), inspection date, and other information 

such as type of water supply and SEWAGE disposal, status of the PERMIT, 

and personnel certificates that may be required; and

(B) Specific factual observations of violative conditions or other deviations 

from this Code that require correction by the PERMIT HOLDER including: 

(1) Failure of the PERSON IN CHARGE to demonstrate the knowledge 

of foodborne illness prevention, application of HACCP principles, 

and the requirements of this Code as specified under § 2-102.11,

(2) Failure of FOOD EMPLOYEES, CONDITIONAL EMPLOYEES, and the 

PERSON IN CHARGE to report a disease or medical condition as 

specified under ¶¶ 2-201.11(B) and (D),

(3) Nonconformance with PRIORITY ITEMS OR PRIORITY FOUNDATION 

ITEMS of this Code,

(4) Failure of the appropriate FOOD EMPLOYEES to demonstrate their 

knowledge of, and ability to perform in accordance with, the 

procedural, monitoring, verification, and corrective action practices 

required by the REGULATORY AUTHORITY as specified under 

§ 8-103.12,

(5) Failure of the PERSON IN CHARGE to provide records required by 

the REGULATORY AUTHORITY for determining conformance with a 

HACCP PLAN as specified under Subparagraph 8-201.14(D)(6), and

(6) Nonconformance with CRITICAL LIMITS of a HACCP PLAN.

8-403.20 Specifying Time Frame for Corrections.
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The REGULATORY AUTHORITY shall specify on the inspection report form the time 

frame for correction of the violations as specified under §§ 8-404.11, 8-405.11, 

and 8-406.11. 

8-403.30 Issuing Report and Obtaining Acknowledgment of Receipt.

At the conclusion of the inspection and according to LAW, the REGULATORY 

AUTHORITY shall provide a copy of the completed inspection report and the notice 

to correct violations to the PERMIT HOLDER or to the PERSON IN CHARGE, and 

request a signed acknowledgment of receipt. 

8-403.40 Refusal to Sign Acknowledgment.

The regulatory authority shall: 

(A) Inform a PERSON who declines to sign an acknowledgment of receipt of 

inspectional findings as specified in § 8-403.30 that:

(1) An acknowledgment of receipt is not an agreement with findings,

(2) Refusal to sign an acknowledgment of receipt will not affect the 

PERMIT HOLDER'S obligation to correct the 

violations noted in the inspection report within the time frames 

specified, and

(3) A refusal to sign an acknowledgment of receipt is noted in the 

inspection report and conveyed to the REGULATORY AUTHORITY'S

historical record for the FOOD ESTABLISHMENT; and

(B) Make a final request that the PERSON IN CHARGE sign an 

acknowledgment receipt of inspectional findings.

8-403.50 Public Information.

Except as specified in § 8-202.10, the REGULATORY AUTHORITY shall treat the 

inspection report as a public document and shall make it available for disclosure

to a PERSON who requests it as provided in LAW. 

8-404 Imminent Health Hazard

8-404.11 Ceasing Operations and Reporting.

(A) Except as specified in ¶ (B) and (C) of this section, a PERMIT HOLDER shall 

immediately discontinue operations and notify the REGULATORY AUTHORITY if an 

IMMINENT HEALTH HAZARD may exist because of an emergency such as a fire, 

flood, extended interruption of electrical or water service, SEWAGE backup, 

misuse of POISONOUS OR TOXIC MATERIALS, onset of an apparent foodborne illness 

outbreak, gross insanitary occurrence or condition, or other circumstance that 

may endanger public health. P

(B) A PERMIT HOLDER need not discontinue operations in an area of an 

establishment that is unaffected by the IMMINENT HEALTH HAZARD. 
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Chapter 8 - 14

(C) Considering the nature of the potential hazard involved and the complexity of 

the corrective action needed, the regulatory authority may agree to continuing 

operations in the event of an extended interruption of electrical or water service 

if:

(1) A written emergency operating plan has been approved;

(2) Immediate corrective action is taken to eliminate, prevent, or control 

any food safety risk and imminent health hazard associated with the 

electrical or water service interruption; and

(3) The regulatory authority is informed upon implementation of the written 

emergency operating plan.

8-404.12 Resumption of Operations.

If operations are discontinued as specified under § 8-404.11 or otherwise 

according to LAW, the PERMIT HOLDER shall obtain approval from the REGULATORY 

AUTHORITY before resuming operations. 

8-405 Violation of Priority Item or Priority Foundatio Item

8-405.11 Timely Correction.

(A) Except as specified in ¶ (B) of this section, a PERMIT HOLDER shall at the time 

of inspection correct a violation of a PRIORITY ITEM or PRIORITY FOUNDATION ITEM of 

this Code and implement corrective actions for a HACCP PLAN provision that is 

not in compliance with its CRITICAL LIMIT. Pf

(B) Considering the nature of the potential hazard involved and the complexity of 

the corrective action needed, the regulatory authority may agree to or specify a 

longer time frame, not to exceed:

(1) 72 hours after the inspection, for the permit holder to correct violations 

of a priority item; or

(2) 10 calendar days after the inspection, for the permit holder to correct 

violations of a priority foundation item or HACCP plan deviations.

8-405.20 Verification and Documentation of Correction.

(A) After observing at the time of inspection a correction of a violation of a 

PRIORITY ITEM or PRIORITY FOUNDATION ITEM or a HACCP PLAN deviation, the 

REGULATORY AUTHORITY shall enter the violation and information about the 

corrective action on the inspection report.

(B) As specified under ¶ 8-405.11(B), after receiving notification that the PERMIT 

HOLDER has corrected a violation of a PRIORITY ITEM OR PRIORITY FOUNDATION ITEM 

or HACCP PLAN deviation, or at the end of the specified period of time, the 

REGULATORY AUTHORITY shall verify correction of the violation, document the 

information on an inspection report, and enter the report in the REGULATORY 

AUTHORITY'S records. 

8-406 Core Item Violation
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8-406.11 Time Frame for Correction.

(A) Except as specified in ¶ (B) of this section, the PERMIT HOLDER shall correct 

CORE ITEMS by a date and time agreed to or specified by the REGULATORY 

AUTHORITY but no later than 90 calendar days after the inspection. 

(B) The regulatory authority may approve a compliance schedule that extends 

beyond the time limits specified under ¶ (A) of this section if a written schedule of 

compliance is submitted by the permit holder and no health hazard exists or will 

result from allowing an extended schedule for compliance. 

8-5 Prevention of Foodborne Disease Transmission By Employees

8-501 Investigation and Control

8-501.10 Obtaining Information: Personal History of Illness, Medical 

Examination, and Specimen Analysis.

The REGULATORY AUTHORITY shall act when it has reasonable cause to believe 

that a FOOD EMPLOYEE or CONDITIONAL EMPLOYEE has possibly transmitted 

disease; may be infected with a disease in a communicable form that is 

transmissible through FOOD; may be a carrier of infectious agents that cause a 

disease that is transmissible through FOOD; or is affected with a boil, an infected 

wound, or acute respiratory infection, by: 

(A) Securing a confidential medical history of the FOOD EMPLOYEE or 

CONDITIONAL EMPLOYEE suspected of transmitting disease or making other 

investigations as deemed appropriate; and 

(B) Requiring appropriate medical examinations, including collection of 

specimens for laboratory analysis, of a suspected FOOD EMPLOYEE or 

CONDITIONAL EMPLOYEE. 

8-501.20 Restriction or Exclusion of Food Employee, or Summary 

Suspension of Permit.

Based on the findings of an investigation related to a FOOD EMPLOYEE or 

CONDITIONAL EMPLOYEE who is suspected of being infected or diseased, the 

REGULATORY AUTHORITY may issue an order to the suspected FOOD EMPLOYEE,

CONDITIONAL EMPLOYEE or PERMIT HOLDER instituting one or more of the following 

control measures: 

(A) RESTRICTING the FOOD EMPLOYEE or CONDITIONAL EMPLOYEE;

(B) EXCLUDING the FOOD EMPLOYEE or CONDITIONAL EMPLOYEE; or

(C) Closing the FOOD ESTABLISHMENT by summarily suspending a PERMIT to 

operate in accordance with LAW. 

8-501.30 Restriction or Exclusion Order: Warning or Hearing Not 

Required, Information Required in Order.

Based on the findings of the investigation as specified in § 8-501.10 and to 

control disease transmission, the REGULATORY AUTHORITY may issue an order of 
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Chapter 8 - 16

RESTRICTION or EXCLUSION to a suspected FOOD EMPLOYEE or the PERMIT HOLDER

without prior warning, notice of a hearing, or a hearing if the order: 

(A) States the reasons for the RESTRICTION or EXCLUSION that is ordered;

(B) States the evidence that the FOOD EMPLOYEE or PERMIT HOLDER shall 

provide in order to demonstrate that the reasons for the RESTRICTION or 

EXCLUSION are eliminated;

(C) States that the suspected FOOD EMPLOYEE or the PERMIT HOLDER may 

request an appeal hearing by submitting a timely request as provided in 

LAW; and

(D) Provides the name and address of the REGULATORY AUTHORITY

representative to whom a request for an appeal hearing may be made. 

8-501.40 Removal of Exclusions and Restrictions.

The REGULATORY AUTHORITY shall release a FOOD EMPLOYEE, OR CONDITIONAL 

EMPLOYEE from RESTRICTION or EXCLUSION according to LAW and the conditions 

specified under § 2-201.13. 

FDA Food Code 2022 Table of Contents for Annexes

Table of Contents for Annexes - 1

ANNEX 1 COMPLIANCE AND ENFORCEMENT ......................................................... 1

1. PURPOSE ............................................................................................................... 1

2. EXPLANATION........................................................................................................ 1

3. PRINCIPLE.............................................................................................................. 2

4. RECOMMENDATION.............................................................................................. 2

5. PARTS..................................................................................................................... 2

8-6 Constitutional Protection .................................................................................... 2

8-7 Authority............................................................................................................. 3

8-8 Notices............................................................................................................... 3

8-9 Remedies........................................................................................................... 4

ANNEX 2 REFERENCES ............................................................................................... 1

1. UNITED STATES CODE AND CODE OF FEDERAL REGULATIONS ....................................... 1

2. BIBLIOGRAPHY ........................................................................................................... 7

Preface..................................................................................................................... 7

Chapter 1. Purpose and Definitions ......................................................................... 8

Chapter 2. Management and Personnel ................................................................ 11

Chapter 3. Food ..................................................................................................... 24

Chapter 4. Equipment, Utensils, and Linens .......................................................... 53

Chapter 5. Water, Plumbing, and Waste................................................................ 56

Chapter 6 Physical Facilities .................................................................................. 58

Chapter 7. Poisonous or Toxic Materials ............................................................... 60

3. SUPPORTING DOCUMENTS ........................................................................................ 62

Summary of Supporting Documents ...................................................................... 64

4. FOOD DEFENSE GUIDANCE FROM FARM TO TABLE...................................................... 78

ANNEX 3 PUBLIC HEALTH REASONS/ADMINISTRATIVE GUIDELINES.................. 1

CHAPTER 1. PURPOSE AND DEFINITIONS.......................................................................... 1

CHAPTER 2. MANAGEMENT AND PERSONNEL.................................................................. 13

CHAPTER 3. FOOD ....................................................................................................... 72

CHAPTER 4. EQUIPMENT, UTENSILS, AND LINENS ......................................................... 155

CHAPTER 5. WATER, PLUMBING, AND WASTE............................................................... 183

CHAPTER 6. PHYSICAL FACILITIES ............................................................................... 195

CHAPTER 7. POISONOUS OR TOXIC MATERIALS ............................................................ 206

CHAPTER 8. COMPLIANCE AND ENFORCEMENT............................................................. 211

ANNEX 4 MANAGEMENT OF FOOD SAFETY PRACTICES – ACHIEVING ACTIVE 

MANAGERIAL CONTROL OF FOODBORNE ILLNESS RISK FACTORS ................... 1

1. ACTIVE MANAGERIAL CONTROL ................................................................................... 1

2. INTRODUCTION TO HACCP......................................................................................... 4

3. THE HACCP PRINCIPLES ........................................................................................... 6

4. THE PROCESS APPROACH – A PRACTICAL APPLICATION OF HACCP AT RETAIL TO 

ACHIEVE ACTIVE MANAGERIAL CONTROL................................................................ 25

5. FDA RETAIL HACCP MANUALS ................................................................................ 33

6. ADVANTAGES OF USING THE PRINCIPLES OF HACCP ................................................. 34

7. SUMMARY................................................................................................................ 35
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Table of Contents for Annexes - 2

8. ACKNOWLEDGMENTS................................................................................................ 35

9. RESOURCES AND REFERENCES................................................................................. 35

ANNEX 5 CONDUCTING RISK-BASED INSPECTIONS............................................... 1

1. PURPOSE AND SCOPE ................................................................................................ 1

2. RISK-BASED ROUTINE INSPECTIONS ........................................................................... 2

3. WHAT IS NEEDED TO PROPERLY CONDUCT A RISK-BASED INSPECTION? ........................ 4

4. RISK-BASED INSPECTION METHODOLOGY..................................................................... 9

5. ACHIEVING ON-SITE AND LONG-TERM COMPLIANCE ................................................... 28

6. INSPECTION FORM AND SCORING .............................................................................. 33

7. CLOSING CONFERENCE ............................................................................................ 34

8. SUMMARY................................................................................................................ 35

ANNEX 6 FOOD PROCESSING CRITERIA................................................................... 1

1. INTRODUCTION........................................................................................................... 1

2. REDUCED OXYGEN PACKAGING................................................................................... 2

3. SMOKING AND CURING.............................................................................................. 12

ANNEX 7 MODEL FORMS, GUIDES, AND OTHER AIDS ............................................ 1

FORM 1-A CONDITIONAL EMPLOYEE AND FOOD EMPLOYEE INTERVIEW............................ 3

FORM 1-B CONDITIONAL EMPLOYEE OR FOOD EMPLOYEE REPORTING AGREEMENT......... 5

FORM 1-C CONDITIONAL EMPLOYEE OR FOOD EMPLOYEE MEDICAL REFERRAL................ 6

FORM 1-D APPLICATION FOR BARE HAND CONTACT PROCEDURE (AS SPECIFIED IN FOOD 

CODE ¶ 3-301.11(E)) ........................................................................................... 10

FORM 2-A ADOPTION BY REFERENCE......................................................................... 12

FORM 2-B ADOPTION BY SECTION-BY-SECTION REFERENCE ........................................ 15

FORM 3-A FOOD ESTABLISHMENT INSPECTION REPORT ............................................... 18

GUIDE 3-B INSTRUCTIONS FOR MARKING THE FOOD ESTABLISHMENT INSPECTION REPORT,

INCLUDING FOOD CODE REFERENCES FOR RISK FACTORS/INTERVENTIONS AND GOOD 

RETAIL PRACTICES ............................................................................................... 22

CHART 4-A SUMMARY CHART FOR MINIMUM COOKING FOOD TEMPERATURES AND HOLDING 

TIMES REQUIRED BY CHAPTER 3............................................................................ 58

CHART 4-B SUMMARY CHART FOR MINIMUM FOOD TEMPERATURES AND HOLDING 

TIMESREQUIRED BY CHAPTER 3 FOR REHEATING FOODS FOR HOT HOLDING............. 59

CHART 4-C SUMMARY CHART FOR READY-TO-EAT, TIME/TEMPERATURE CONTROL FOR 

SAFETY FOOD) DATE MARKING § 3-501.17(A) – (E) AND DISPOSITION § 3-501.18 ... 60

CHART 4-D FDA FOOD CODE MOBILE FOOD ESTABLISHMENT MATRIX............................ 61

SUMMARY OF CHANGES IN THE 2022 FDA FOOD CODE....................................... 63

GENERAL .................................................................................................................... 63

PREFACE..................................................................................................................... 63

CHAPTER 1. PURPOSE AND DEFINITIONS........................................................................ 63

CHAPTER 2. MANAGEMENT AND PERSONNEL.................................................................. 64

CHAPTER 3. FOOD ....................................................................................................... 65

CHAPTER 4. EQUIPMENT, UTENSILS, AND LINENS ........................................................... 68

CHAPTER 5. WATER, PLUMBING, AND WASTE................................................................. 69
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Table of Contents for Annexes - 3

CHAPTER 6. PHYSICAL FACILITIES ................................................................................. 69

CHAPTER 7. POISONOUS OR TOXIC MATERIALS .............................................................. 69

CHAPTER 8. COMPLIANCE AND ENFORCEMENT............................................................... 70

ANNEX 1. COMPLIANCE AND ENFORCEMENT................................................................... 71

ANNEX 2. REFERENCES................................................................................................ 71

ANNEX 3. PUBLIC HEALTH REASONS/ADMINISTRATIVE GUIDELINES.................................. 73

ANNEX 4. MANAGEMENT OF FOOD PRACTICES-ACHIEVING ACTIVE MANAGERIAL CONTROL 

OF FOODBORNE ILLNESS RISK FACTORS................................................................. 77

ANNEX 5. CONDUCTING RISK-BASED INSPECTION........................................................... 77

ANNEX 6. FOOD PROCESSING CRITERIA ........................................................................ 77

ANNEX 7. MODELS FORMS, GUIDES, AND OTHER AIDS.................................................... 78
FDA Food Code 2022 Annex 1. Compliance and Enforcement

Annex 1 - 1

Annex 1

Compliance and Enforcement

Parts:

1 PURPOSE

2 EXPLANATION

3 PRINCIPLE

4 RECOMMENDATION

5 PARTS

1. PURPOSE

The purpose of this Annex is to set forth provisions, in codified form, that provide a full 

array of enforcement mechanisms while recognizing the diverse statutes and 

regulations that currently govern the operations of the thousands of State and local 

regulatory agencies.

2. EXPLANATION

State or local statutes, regulations, and ordinances vary in their design, specificity, and 

degree of comprehensiveness in that they may:

(A) Contain authorities that provide the basis for certain post-inspection 

compliance strategies but remain silent with respect to other enforcement 

mechanisms;

(B) Include specific requirements that are different from those provided in this 

Annex; and

(C) Be structured so that provisions such as administrative procedures are 

embodied in sections of the law that transcend and are separate from those 

governing food establishments.

Consequently, in this document a deliberate attempt is made to extract those provisions

that could conceptually be adopted as an extension of Chapter 8 if they were 

compatible with existing, governing State and local statutes. The extracted provisions 

are numbered to sequentially follow Chapter 8 but are placed in this Annex so that 

regulatory agencies can revise them to be consistent with their statutes and their needs 

as discussed in the Recommendation, below.

It is anticipated that adoption of this Code will be facilitated by the fact that:
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Annex 1 - 2

(A) The compliance provisions of Chapter 8 that should be an integral part of 

State or local food regulations are part of the text of the Code; and 

(B) The administrative and judicial enforcement provisions that are critical to the 

framework of a food regulatory program, but that may be repetitive or discrepant 

when compared to State or local statutes, are separated in this Annex.

3. PRINCIPLE

Although the situations necessitating escalated enforcement actions comprise a small 

percentage of those encountered by the regulator, a full spectrum of enforcement tools 

must be available where immediate hazards exist, or where compliance is not obtained 

voluntarily. Thus, a jurisdiction must have in place both the necessary statutory 

framework that includes a broad-based, well-defined enforcement component and 

regulations that specify the requirements within those legal authorities. It is imperative 

that there be clearly stated and legally sound rules that include the criteria for 

compliance and enforcement, the responsibilities of all parties, sanctions for 

noncompliance, and due process guarantees.

4. RECOMMENDATION

FDA recommends that agencies assess their statutory provisions that pertain to food 

establishments in light of this Annex and consider proposing changes to their statutes 

and regulations where they determine that provisions contained within this Annex will 

strengthen their programs. Such an assessment may involve reviewing problems 

encountered in attempts to prosecute under existing State or local provisions; 

considering comments received by the regulatory authority about its enforcement 

process; consulting with staff and legal counsel to identify gaps or weaknesses in the 

provisions; comparing provisions with sister agencies for comprehensiveness, equity, 

and uniformity; and seeking input from outside sources that have experience in taking, 

or being the subject of, enforcement actions.

Appropriate wording and cross referencing changes to the provisions in this Annex may 

be necessary, based on whether they are adopted as statutes or regulations. 

Modifications to the adoption forms (Forms #2-A and #2-B in Annex 7) may also be 

necessary based on that decision.

5. PARTS

8-6 Constitutional Protection

8-601 Procedural Safeguards

8-601.10 Preservation of Rights.
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The REGULATORY AUTHORITY shall justly apply the remedies according to LAW and 

this Code, to preserve the rights to equal protection and due process of a PERSON

to whom the remedies are applied. 

8-602 Judicial Review

8-602.10 Rights of Recipients of Orders or Decisions. 

A recipient of a REGULATORY AUTHORITY order or decision may file a petition for 

judicial review in a court of competent jurisdiction after available administrative 

appeal remedies are exhausted.

8-7 Authority

8-701 Legal Authority

8-701.10 Adoption of Regulations. 

The REGULATORY AUTHORITY shall have the requisite legal authority from the 

appropriate statute/ordinance making authority to adopt and enforce regulations 

to carry out the administrative and judicial enforcement provisions of the Code 

that are critical to the framework of a Food Establishment regulatory program, to 

include the requirement for the issuance of a Permit.

8-701.11 Implementation of Regulations.

Appropriate modifications to the adoption forms (Form #2-A (Adoption by 

Reference short form) and #2-B (Adoption by Section-by-Section Reference)) in 

Annex 7, where used, shall be made consistent with said legal authority to enact 

regulations and enforce compliance of the Code, whether they are adopted as 

statutes or regulations.

8-701.20 Basis for Action. 

The REGULATORY AUTHORITY shall clearly state and reference within the Code the 

legally sound basis for compliance and enforcement action, the responsibilities of 

the parties, sanctions for noncompliance and due process.

8-8 Notices

8-801 Service of Notice

8-801.10 Proper Methods. 
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Annex 1 - 4

(Note: Adoption of this section provides the basis for serving notice of 

inspectional findings as specified in § 8-403.30 and would be cited there.) 

A notice issued in accordance with this Code shall be considered to be properly 

served if it is served by one of the following methods: 

(A) The notice is personally served by the REGULATORY AUTHORITY, a LAW

enforcement officer, or a PERSON authorized to serve a civil process to the 

PERMIT HOLDER, the PERSON IN CHARGE, or PERSON operating a FOOD 

ESTABLISHMENT without a PERMIT; 

(B) The notice is sent by the REGULATORY AUTHORITY to the last known 

address of the PERMIT HOLDER or the PERSON operating a FOOD 

ESTABLISHMENT without a PERMIT, by registered or certified mail or by other 

public means so that a written acknowledgment of receipt may be 

acquired; or

(C) The notice is provided by the REGULATORY AUTHORITY in accordance 

with another manner of service authorized in LAW.

8-801.20 Restriction or Exclusion Order, Hold Order or Summary 

Suspension. 

An EMPLOYEE RESTRICTION or EXCLUSION order, an order to hold and not distribute 

FOOD, such as a hold, detention, embargo, or seizure order which is hereinafter 

referred to as a hold order, or a summary suspension order shall be: 

(A) Served as specified in ¶ 8-801.10(A); or

(B) Clearly posted by the regulatory authority at a public entrance to the 

food establishment and a copy of the notice sent by first class mail to the 

permit holder or to the owner or custodian of the food, as appropriate.

8-801.30 When Notice is Effective. 

Service is effective at the time of the notice's receipt or if service is made as 

specified in ¶ 8-801.20(B), at the time of the notice's posting. 

8-801.40 Proof of Proper Service. 

Proof of proper service may be made by affidavit of the PERSON making service 

or by admission of the receipt signed by the PERMIT HOLDER, the PERSON

operating a FOOD ESTABLISHMENT without a PERMIT to operate, or an authorized 

agent.

8-9 Remedies

8-901 Criteria for Seeking Remedies

Administrative
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8-902 Inspection Orders

8-903 Holding, Examination, and Destruction of Food

8-904 Summary Permit Suspension

8-905 Hearings Administration

8-906 Hearing Officer, Purpose Qualifications, Appointment, and Powers

8-907 Rights of Parties and Evidence

8-908 Settlement

Judicial

8-909 Inspection Orders-901 Criteria for Seeking Remedies 

8-910 Means of Instituting Judicial Enforcement Proceedings

8-911 Criminal Proceedings

8-912 Injunctive Proceeding

8-913 Civil Proceedings

8-901 Criteria for Seeking Remedies

8-901.10 Conditions Warranting Remedy.

The REGULATORY AUTHORITY may seek an administrative or judicial remedy to 

achieve compliance with the provisions of this Code if a PERSON operating a FOOD 

ESTABLISHMENT or EMPLOYEE: 

(A) Fails to have a valid permit to operate a food establishment as 

specified under § 8-301.11;

(B) Violates any term or condition of a permit as specified under 

§ 8-304.11;

(C) Allows serious or repeated code violations to remain uncorrected 

beyond time frames for correction approved, directed, or ordered by the 

regulatory authority under ¶¶ 8-405.11(A) and (B), and ¶¶ 8-406.11(A) and 

(B);

(D) Fails to comply with a regulatory authority order issued as specified in 

§ 8-501.20 concerning an employee or conditional employee suspected of 

having a disease transmissible through food by infected persons;

(E) Fails to comply with a hold order as specified in § 8-903.10;

(F) Fails to comply with an order issued as a result of a hearing for an 

administrative remedy as specified in § 8-906.40; or
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Annex 1 - 6

(G) Fails to comply with a summary suspension order issued by the 

regulatory authority as specified in §§ 8-801.20 and 8-904.10. 

Administrative

8-902 Inspection Orders

8-902.10 Gaining Access to Premises and Records. 

(Note: Adoption of this section provides the basis for Subparagraph 8-

402.20(A)(3) and § 8-402.40 and would be cited there.)

The REGULATORY AUTHORITY may order access for one or more of the following 

purposes, subject to LAW for gaining access: 

(A) If admission to the PREMISES of a FOOD ESTABLISHMENT is denied or 

other circumstances exist that would justify an inspection order under LAW, 

to make an inspection including taking photographs;

(B) To examine and sample the FOOD; and

(C) To examine the records on the PREMISES relating to FOOD purchased, 

received, or used by the FOOD ESTABLISHMENT. 

8-902.20 Contents of Inspection Order. 

The REGULATORY AUTHORITY'S inspection order shall: 

(A) Stipulate that access be allowed on or to the described PREMISES,

FOOD, or records under the order's provisions;

(B) Provide a description that specifies the PREMISES, FOOD, or records 

subject to the order; and

(C) Specify areas to be accessed and activities to be performed.

8-903 Holding, Examination, and Destruction of Food 

8-903.10 Hold Order, Justifying Conditions and Removal of Food. 

(Note: Adoption of this section provides the basis for ¶ 3-202.18(B) and 

would be cited there.) 

(A) According to time limits imposed by LAW, the REGULATORY AUTHORITY

may place a hold order on a FOOD that: 

(1) Originated from an unAPPROVED source; 

(2) May be unsafe, ADULTERATED, or not honestly presented; 
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(3) Is not labeled according to LAW, or, if raw MOLLUSCAN 

SHELLFISH, is not tagged or labeled according to LAW; or

(4) Is otherwise not in compliance with this Code. 

(B) If the REGULATORY AUTHORITY has reasonable cause to believe that the 

hold order will be violated, or finds that the order is violated, the 

REGULATORY AUTHORITY may remove the FOOD that is subject to the order 

to a place of safekeeping. 

8-903.20 Hold Order, Warning or Hearing Not Required. 

The REGULATORY AUTHORITY may issue a hold order to a PERMIT HOLDER or to a 

PERSON who owns or controls the FOOD, as specified in § 8-903.10, without prior 

warning, notice of a hearing, or a hearing on the hold order. 

8-903.30 Hold Order, Contents. 

The hold order notice shall: 

(A) State that FOOD subject to the order may not be used, sold, moved 

from the FOOD ESTABLISHMENT, or destroyed without a written release of 

the order from the REGULATORY AUTHORITY;

(B) State the specific reasons for placing the FOOD under the hold order 

with reference to the applicable provisions of this Code and the HAZARD or 

adverse effect created by the observed condition;

(C) Completely identify the FOOD subject to the hold order by the common 

name, the label information, a container description, the quantity, 

REGULATORY AUTHORITY'S tag or identification information, and location;

(D) State that the PERMIT HOLDER has the right to an appeal hearing and 

may request a hearing by submitting a timely request as specified in 

§§ 8-905.10 and 8-905.20;

(E) State that the REGULATORY AUTHORITY may order the destruction of the 

FOOD if a timely request for an appeal hearing is not received; and

(F) Provide the name and address of the REGULATORY AUTHORITY

representative to whom a request for an appeal hearing may be made. 

8-903.40 Hold Order, Official Tagging of Food. 

(A) The REGULATORY AUTHORITY shall securely place an official tag or label 

on the FOOD or containers or otherwise conspicuously identify FOOD

subject to the hold order. 

(B) The tag or other method used to identify a FOOD that is the subject of a 

hold order shall include a summary of the provisions specified in 

§ 8-903.30 and shall be signed and dated by the REGULATORY AUTHORITY. 
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8-903.51 Hold Order, Food May Not Be Used or Moved. 

(A) Except as specified in ¶ (B) of this section, a FOOD placed under a hold 

order may not be used, sold, served, or moved from the establishment by 

any PERSON. 

(B) The REGULATORY AUTHORITY may allow the PERMIT HOLDER the 

opportunity to store the FOOD in an area of the FOOD ESTABLISHMENT if the 

FOOD is protected from subsequent deterioration and the storage does not 

restrict operations of the establishment. 

8-903.60 Examining, Sampling, and Testing Food. 

The REGULATORY AUTHORITY may examine, sample, and test FOOD in order to 

determine its compliance with this Code. 

8-903.70 Hold Order, Removing the Official Tag. 

Only the REGULATORY AUTHORITY may remove hold order tags, labels, or other 

identification from FOOD subject to a hold order. 

8-903.80 Destroying or Denaturing Food. 

If a hold order is sustained upon appeal or if a timely request for an appeal 

hearing is not filed, the REGULATORY AUTHORITY may order the PERMIT HOLDER or 

other PERSON who owns or has custody of the FOOD to bring the FOOD into 

compliance with this Code or to destroy or denature the FOOD under the 

REGULATORY AUTHORITY'S supervision.

8-903.90 Releasing Food from Hold Order. 

The REGULATORY AUTHORITY shall issue a notice of release from a hold order and 

shall remove hold tags, labels, or other identification from the FOOD if the hold 

order is vacated. 

8-904 Summary Permit Suspension 

8-904.10 Conditions Warranting Action. 

The REGULATORY AUTHORITY may summarily suspend a PERMIT to operate a FOOD 

ESTABLISHMENT if it determines through inspection, or examination of EMPLOYEES,

FOOD, records, or other means as specified in this Code, that an IMMINENT HEALTH 

HAZARD exists. 

8-904.20 Summary Suspension, Warning or Hearing Not Required. 
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Annex 1 - 9

The REGULATORY AUTHORITY may summarily suspend a PERSON'S PERMIT as 

specified in § 8-904.10 by providing written notice as specified in § 8-801.20 of 

the summary suspension to the PERMIT

HOLDER or PERSON IN CHARGE, without prior warning, notice of a hearing, or a 

hearing. 

8-904.30 Contents of the Notice. 

A summary suspension notice shall state: 

(A) That the FOOD ESTABLISHMENT PERMIT is immediately suspended and that all 

FOOD operations shall immediately cease;

(B) The reasons for summary suspension with reference to the provisions of this 

Code that are in violation;

(C) The name and address of the REGULATORY AUTHORITY representative to whom

a written request for reinspection may be made and who may certify that reasons 

for the suspension are eliminated; and

(D) That the PERMIT HOLDER may request an appeal hearing by submitting a 

timely request as specified in §§ 8-905.10 and 8-905.20. 

8-904.40 Time Frame for Reinspection. 

After receiving a written request from the PERMIT HOLDER stating that the 

conditions cited in the summary suspension order no longer exist, the 

REGULATORY AUTHORITY shall conduct a reinspection of the FOOD ESTABLISHMENT

for which the PERMIT was summarily suspended within 2 business days, which 

means 2 days during which the REGULATORY AUTHORITY'S office is open to the 

public.

8-904.50 Term of Suspension, Reinstatement of Permit. 

(A) A summary suspension shall remain in effect until the conditions cited in the 

notice of suspension no longer exist and their elimination has been confirmed by 

the REGULATORY AUTHORITY through reinspection and other means as appropriate. 

(B) The suspended PERMIT shall be reinstated immediately if the REGULATORY

AUTHORITY determines that the public health HAZARD or nuisance no longer exists. 

A notice of reinstatement shall be provided to the PERMIT HOLDER or PERSON IN 

CHARGE. 

8-905 Hearings Administration 

8-905.10 Response to Notice of Hearing or Request for Hearing, Basis and 

Time Frame. 
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Annex 1 - 10

(Note: Adoption of this section provides the basis for ¶¶ 8-303.30(C) and 

8-501.30(C). ¶¶ 8-905.10(C) and (D) would be cited there.) 

(A) A PERSON who receives a notice of hearing for an administrative remedy as 

specified in Part 8-8, § 8-901.10, or ¶ 8-905.30(A) and elects to respond to the 

notice shall file a response to notice as specified in § 8-905.20 within 7 calendar 

days after service. 

(B) A PERMIT applicant may request a hearing regarding the disposition of an 

application for a new or revised PERMIT if the REGULATORY AUTHORITY does not 

issue or deny the PERMIT within the time frame specified in LAW. 

(C) A PERMIT HOLDER may request a hearing to address concerns about the 

REGULATORY AUTHORITY'S denial of application for a PERMIT or request for a 

VARIANCE, or compliance actions, except that a hearing request does not stay the 

REGULATORY AUTHORITY'S restriction or exclusion of EMPLOYEES specified in 

§§ 8-501.10 - 8-501.40, a hold order specified in § 8-903.10, or the imposition of 

a summary suspension specified in § 8-904.10. 

(D) A PERSON desiring a hearing in response to a denial of an application for 

PERMIT or an adverse administrative determination shall submit a hearing request 

to the REGULATORY AUTHORITY within 10 calendar days of the date of the denial, 

inspection, or compliance action, unless the REGULATORY AUTHORITY specifies in 

certain situations that the request shall be submitted within a shorter period of 

time. 

8-905.20 Response to a Notice of Hearing or Request for Hearing, Required 

Form and Contents. 

A response to a hearing notice or a request for hearing as specified in § 8-905.10 

shall be in written form and contain the following: 

(A) If a response to notice of hearing,

(1) An admission or denial of each allegation of fact;

(2) A statement as to whether the respondent waives the right to a 

hearing; and may also contain

(3) A statement of defense, mitigation, or explanation concerning 

any allegation of fact; and

(4) A request to the REGULATORY AUTHORITY for a settlement of the 

proceeding by consent agreement, if the REGULATORY AUTHORITY

will provide this opportunity. 

(B) If a request for hearing,

(1) A statement of the issue of fact specified in ¶ 8-905.30(B) for 

which the hearing is requested; and
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Annex 1 - 11

(2) A statement of defense, mitigation, denial, or explanation 

concerning each allegation of fact. 

(C) If either a response to notice of hearing or a request for a hearing,

(1) A statement indicating whether the presence of witnesses for 

the REGULATORY AUTHORITY is required; and

(2) The name and address of the respondent's or requester's 

legal counsel, if any. 

8-905.30 Provided Upon Request. 

The REGULATORY AUTHORITY shall hold hearings according to LAW and the 

provisions of this Code: 

(A) As determined necessary by LAW or the REGULATORY AUTHORITY to 

accomplish the purpose and intent of this Code specified in § 8-101.10; 

and

(B) As requested by a PERMIT applicant or a PERMIT HOLDER if: 

(1) Requested as specified in § 8-905.10, and

(2) The request demonstrates that there is a genuine and material 

issue of fact that justifies that a hearing be held. 

8-905.40 Provided in Accordance with Law. 

Hearings shall be conducted according to LAW, administrative procedures, and

this Code. 

8-905.50 Timeliness, Appeal Proceeding Within 5 Business Days, Other 

Proceeding Within 30 Calendar Days.

(A) The REGULATORY AUTHORITY shall afford a hearing: 

(1) Except as provided in ¶ (B) of this section, within 5 business days after 

receiving a written request for an appeal hearing from: 

(a) A PERSON who is EXCLUDED by the REGULATORY AUTHORITY

from working in a FOOD ESTABLISHMENT as specified in §§ 8-501.10 

- 8-501.40,

(b) A PERMIT HOLDER or PERSON whose FOOD is subject to a hold 

order as specified in Subpart 8-903, or

(c) A PERMIT HOLDER whose PERMIT is summarily suspended as 

specified in Subpart 8-904; and 

(2) Within 30 calendar days but no earlier than 7 calendar days after 

the service of a hearing notice to consider administrative remedies for 
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Annex 1 - 12

other matters as specified in ¶ 8-905.10(C) or for matters as 

determined necessary by the REGULATORY AUTHORITY.

(B) A PERMIT HOLDER or PERSON who submits a request for a hearing as specified 

in Subparagraphs (A)(1)(a)-(c) of this section may waive the prompt hearing in 

the written request to the REGULATORY AUTHORITY. 

8-905.60 Notice, Contents. 

A notice of hearing shall contain the following information: 

(A) Time, date, and place of the hearing;

(B) Purpose of the hearing;

(C) Facts that constitute the basis or reason for the hearing including 

specific details of violations or allegations;

(D) The rights of the respondent, including the right to be represented by 

counsel and to present witnesses and evidence on the respondent's 

behalf as specified in § 8-907.10;

(E) At the REGULATORY AUTHORITY'S discretion, the procedure for the 

respondent to request an offer from the REGULATORY AUTHORITY to settle 

the matter;

(F) The consequences of failing to appear at the hearing;

(G) The maximum sanctions or penalties as specified in ¶¶ 8-906.40(B) -

(D) that may result from the hearing if the hearing concerns a proposed 

administrative remedy and if the facts are found to be as alleged;

(H) If the hearing concerns a proposed administrative remedy, a statement 

specifying the form and time frame for response as specified in § 8-

905.10;

(I) Notification that the written response shall include the information 

specified in § 8-905.20; and

(J) The name and address of the PERSON to whom such written response 

shall be addressed. 

8-905.70 Proceeding Commences Upon Notification. 

A hearing proceeding commences at the time the REGULATORY AUTHORITY notifies 

the respondent of the hearing proceeding. 

8-905.80 Procedure, Expeditious and Impartial. 

Hearings shall be conducted in an expeditious and impartial manner.

8-905.90 Confidential. 
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Annex 1 - 13

(A) Hearings or portions of hearings may be closed to the public:

(1) If compelling circumstances, such as the need to discuss in the 

hearing a PERSON'S medical condition or a FOOD ESTABLISHMENT'S

trade secrets, indicate that it would be prudent; and

(2) According to LAW, such as an open meetings LAW. 

(B) A party to a hearing shall maintain confidentiality of discussions that 

warrant closing the hearing to the public. 

8-905.100 Record of Proceeding. 

A complete record of a hearing shall be prepared under the direction of 

the PERSON conducting the hearing and maintained as part of the 

REGULATORY AUTHORITY'S records for the FOOD ESTABLISHMENT. Except 

as required by LAW, a verbatim transcript of the hearing need not be 

prepared. 

8-906 Hearing Officer, Purpose Qualifications, Appointment, and Powers

8-906.10 Appointment by Regulatory Authority and Purpose. 

The REGULATORY AUTHORITY may appoint a PERSON such as an adjudicator, 

administrative LAW judge, or examiner, hereinafter referred to as a hearing 

officer, who presides over a proceeding initiated by the REGULATORY AUTHORITY or 

by a PERSON contesting an action of the REGULATORY AUTHORITY, to perform one 

or more of the following: 

(A) Hear the facts presented by an applicant or a PERMIT HOLDER;

(B) Make a decision or recommendation concerning administrative 

remedies to achieve compliance with this Code; or

(C) Address other concerns or allegations appropriately raised according 

to LAW, in the matter before the hearing officer. 

8-906.20 Qualifications. 

A hearing officer shall be knowledgeable of the provisions of this chapter and the 

LAW as they relate to hearings, and be: 

(A) A REGULATORY AUTHORITY representative other than the PERSON who 

inspects the FOOD ESTABLISHMENT or who has any other role in making the 

decision that is being contested; or

(B) An individual who is not employed by the REGULATORY AUTHORITY. 

8-906.30 Powers, Administration of Hearings. 
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Annex 1 - 14

(A) A hearing officer shall have the following powers in a hearing in which the 

hearing officer presides: 

(1) Setting and conducting the course of a hearing requested in 

accordance with or authorized by this Code,

(2) Issuing subpoenas in the name of the REGULATORY AUTHORITY at the 

request of a party to a hearing, administering oaths and affirmations, 

examining witnesses, receiving evidence,

(3) Approving a consent agreement on the issues involved in the hearing 

entered into by the REGULATORY AUTHORITY and the respondent after the 

respondent receives a hearing notice,

(4) Sustaining, modifying, rescinding, or vacating an order or directive of 

the REGULATORY AUTHORITY in an appeal hearing proceeding, and if the 

order or directive is sustained, ordering appropriate measures to execute 

the REGULATORY AUTHORITY'S order or directive; and

(B) Unless a party appeals to the head of the REGULATORY AUTHORITY within 15 

days of the hearing or a lesser number of days specified by the hearing officer: 

(1) Rendering a binding decision and final order in a proceeding after 

conducting a hearing, if the respondent has not waived the right to a 

hearing, and

(2) Then notifying the respondent of the decision and the order which 

contains the findings and conclusions of LAW. 

8-906.40 Powers, Administrative Remedies. 

The hearing officer shall have the following powers in a hearing proceeding 

concerning an administrative remedy specified in §§ 8-901.10 and 8-905.30: 

(A) Issuing orders to abate or correct violations of this Code and 

establishing a schedule for the abatement or correction of violations;

(B) Making a finding of fact regarding the occurrence of each violation and 

assessing, levying, and ordering a reasonable civil penalty, according to

LAW and not to exceed the amount specified in ¶ 8-913.10(B) for each 

violation of this Code that is alleged and found to be committed, and 

calculated based on each day a violation occurs as specified in ¶ 8-

913.10(C);

(C) Suspending, revoking, modifying, or imposing reasonable restrictions 

or conditions on a PERMIT to operate a FOOD ESTABLISHMENT, or ordering 

the closure of a FOOD ESTABLISHMENT that is operated without a valid 

PERMIT as required under § 8-301.11;

(D) Making a finding of fact regarding the occurrence of each violation of 

the REGULATORY AUTHORITY'S or hearing officer's LAWful order issued in 

accordance with this Code and assessing, levying, and ordering a 
FDA Food Code 2022 Annex 1. Compliance and Enforcement

Annex 1 - 15

reasonable civil penalty, in accordance with LAW and not to exceed the 

amount specified in ¶ 8-913.10(B) for each violation of this Code that is 

alleged and found to be committed, and calculated based on each day a 

violation occurs as specified in ¶ 8-913.10(C);

(E) Deferring or suspending the imposition of a decision or execution of an 

order, and imposing a probationary period, upon the condition that the 

respondent comply with the hearing officer's reasonable terms and 

conditions;

(F) Dismissing the appeal if the matter is settled between the REGULATORY 

AUTHORITY and the respondent after a hearing notice is served;

(G) Ordering reinspection of a FOOD ESTABLISHMENT to determine 

compliance with a hearing officer's order;

(H) Suspending or ordering the payment of a fee established by the 

REGULATORY AUTHORITY for a reinspection that is required to determine 

compliance and for the reinstatement of a PERMIT after suspension;

(I) Retaining and exercising jurisdiction for a specific period of time not to 

exceed 90 calendar days after the hearing officer's decision and final order 

is issued, over a respondent who receives a hearing notice; and

(J) Modifying or setting aside an order by rehearing upon the hearing 

officer's own motion, the motion of the REGULATORY AUTHORITY, or the 

motion of the respondent. 

8-907 Rights of Parties and Evidence

8-907.10 Rights of Parties. 

Parties to a hearing may be represented by counsel, examine and cross examine 

witnesses, and present evidence in support of their position. 

8-907.20 Evidence to be Presented by the Regulatory Authority. 

The REGULATORY AUTHORITY shall present at the hearing its evidence, orders, 

directives, and reports related to the proposed or appealed administrative 

remedy. 

8-907.30 Evidence to be Excluded. 

Evidence shall be EXCLUDED: 

(A) If it is irrelevant, immaterial, unduly repetitious, or excludable on 

constitutional or statutory grounds or on the basis of evidentiary privilege 

recognized by the state's courts; or

(B) Otherwise according to LAW. 
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Annex 1 - 16

8-907.40 Testimony under Oath. 

Testimony of parties and witnesses shall be made under oath or affirmation 

administered by a duly authorized official. 

8-907.50 Written Evidence. 

Written evidence may be received if it will expedite the hearing without 

substantial prejudice to a party's interests. 

8-907.60 Documentary Evidence. 

Documentary evidence may be received in the form of a copy or excerpt. 

8-908 Settlement

8-908.10 Authorization. 

The REGULATORY AUTHORITY may settle a case after a notice of hearing is served 

by providing a respondent with an opportunity to request a settlement before a 

hearing commences on the matter and by entering into a consent agreement with 

the respondent. 

8-908.20 Respondent Acceptance of Consent Agreement Is Waiver of Right 

to Appeal. 

Respondents accepting a consent agreement waive their right to a hearing on 

the matter. 

Judicial

8-909 Inspection Orders 

8-909.10 Gaining Access to Premises and Records. 

(Note: Adoption of this section provides the basis for Subparagraph 8-

402.20(A)(3) and § 8-402.40 and would be cited there.) 

The REGULATORY AUTHORITY may seek access for one or more of the following 

purposes, according to LAW for gaining access: 

(A) If admission to the PREMISES of a FOOD ESTABLISHMENT is denied or 

other circumstances exist that would justify an inspection order under LAW, 

to make an inspection including taking photographs;

(B) To examine and sample the FOOD; and
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Annex 1 - 17

(C) To examine the records on the PREMISES relating to FOOD purchased, 

received, or used by the FOOD ESTABLISHMENT. 

8-909.20 Contents of Court Petition. 

In the absence of a specific set of requirements established by LAW, in its petition 

to the court to compel access the REGULATORY AUTHORITY shall: 

(A) Describe in detail the PREMISES, FOOD, or records on or to which 

access was denied;

(B) Detail the legal authority to regulate and to have access for a specific 

purpose on or to the PREMISES, FOOD, or records where access was 

denied; and

(C) Provide information that the FOOD ESTABLISHMENT possesses a valid 

PERMIT from the REGULATORY AUTHORITY and that it applies to the PREMISES

where access was denied; or

(D) Provide information that a PERSON is known to be or suspected of 

operating a FOOD ESTABLISHMENT without possessing a valid PERMIT as 

specified in LAW and under this Code. 

8-909.30 Sworn Statement of Denied Access. 

The REGULATORY AUTHORITY shall demonstrate to the court by affidavit, sworn 

testimony, or both that: 

(A) Access on or to the PREMISES, FOOD, or records was denied after the 

REGULATORY AUTHORITY acted as specified in §§ 8-402.20 and 8-402.30; or

(B) There is reason to believe that a FOOD ESTABLISHMENT is being 

operated on the PREMISES and that access was denied or is sought under 

a REGULATORY AUTHORITY'S reasonable administrative plan to enforce the 

provisions of this Code. 

8-909.40 Contents of an Order. 

Upon petition of the REGULATORY AUTHORITY, the court may issue an inspection 

order that: 

(A) Includes the information specified in ¶¶ 8-902.20(A) - (C); and

(B) Orders or authorizes any other identified agencies and persons 

including LAW enforcement agencies to execute, or assist with the 

execution of, the order. 

8-909.50 Optional Contents of an Order. 

Upon petition of the REGULATORY AUTHORITY, the court may further issue an 

inspection order that: 
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Annex 1 - 18

(A) Provides a maximum time limit for the order's execution;

(B) Authorizes LAW enforcement officers who assist in the order's 

execution to use necessary force against PERSONS or property to execute 

the order; and

(C) Requires that the agencies or PERSONS ordered or authorized to 

execute the order shall report to the court the date and time of the order's 

execution and the findings reached by the inspection, examination, or 

sampling conducted under the order. 

8-910 Means of Instituting Judicial Enforcement Proceedings

8-910.10 Institution of Proceedings. 

(A) Proceedings to enforce this Code may be instituted by the REGULATORY 

AUTHORITY according to LAW by issuing a citation or summons, by filing a 

misdemeanor complaint affidavit and request for a warrant of arrest with the court 

of competent jurisdiction, or by referring the complaint to a grand jury for 

indictment, as appropriate. 

(B) The REGULATORY AUTHORITY may designate a representative to issue 

summons or citations or sign warrants on behalf of the agency. 

8-911 Criminal Proceedings

8-911.10 Authorities, Methods, Fines, and Sentences. 

(A) The REGULATORY AUTHORITY may seek to enforce the provisions of this Code 

and its orders by instituting criminal proceedings as provided in LAW against the 

PERMIT HOLDER or other PERSONS who violate its provisions. 

(B) A PERSON who violates a provision of this Code shall be guilty of a 

misdemeanor, punishable by: 

(1) A fine of not more than (designate amount) dollars, or by imprisonment 

not exceeding 1 year, or both the fine and imprisonment; or

(2) If the PERSON has been convicted once of violating this Code or if there 

is an intent to defraud or mislead, a fine not exceeding (designate amount) 

or imprisonment not exceeding (designate time) year(s) or both. 

(C) Each day on which a violation occurs is a separate violation under this 

section. 

8-912 Injunctive Proceeding

8-912.10 Petitions for Injunction. 
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Annex 1 - 19

The REGULATORY AUTHORITY may, according to LAW, petition a court of competent 

jurisdiction for temporary or permanent injunctive relief to achieve compliance 

with the provisions of this Code or its orders. 

8-913 Civil Proceedings

8-913.10 Petitions, Penalties, and Continuing Violations. 

(A) The REGULATORY AUTHORITY may petition a court of competent jurisdiction to 

enforce the provisions of this Code or its administrative orders and according to 

LAW collect penalties and fees for violations. 

(B) In addition to any criminal fines and sentences imposed as specified in § 8-

911.10, or to being enjoined as specified in § 8-912.10, a PERSON who violates a 

provision of this Code, any rule or regulation adopted in accordance with LAW

related to FOOD ESTABLISHMENTS within the scope of this Code, or to any term, 

condition, or limitation of a PERMIT issued as specified in §§ 8-303.10 and 8-

303.20 is subject to a civil penalty not exceeding (designate amount). 

(C) Each day on which a violation occurs is a separate violation under this 

section.
FDA Food Code 2022 Annex 2. References

Annex 2 - 1

Annex 2 References

Parts:

1. United States Code and Code of Federal Regulations

2. Bibliography

3. Supporting Documents

4. Food Defense Guidance from Farm to Table

1. United States Code and Code of Federal Regulations

The Food Code makes frequent reference to federal statutes contained in the United 

States Code (USC) and the Code of Federal Regulations (CFR). Copies of the USC and 

CFR can be viewed and copied at government depository libraries or may be purchased 

as follows.

(A) Viewing and Copying the USC or CFR 

(1) Federal Depository Library 

The USC and CFR are widely available for reference and viewing in 

some 1300 "depository libraries" located throughout the United States. 

A Directory of U.S. Government Depository Libraries is published by 

the Joint Committee on Printing of the United States Congress and is 

available through the Superintendent of Documents, U.S. Government 

Printing Office. This publication lists all depository libraries by state, 

city, and congressional district. 

Persons may also obtain information about the location of the 

depository library nearest to them by contacting:

GPO Customer Contact Center, Mail Stop: IDCC

U.S. Government Printing Office

732 North Capitol Street, NW

Washington, DC 20401-0001

(866) 512-1800, Fax (202) 512-2104

Email: ContactCenter@gpo.gov

(2) Internet World Wide Web Information System

The CFRs are available on-line in downloadable form through the 

Internet World Wide Web information system. The source is:

The National Archives and Records Administration

Copies of Federal Regulations - Retrieve CFR by Citation

Provided through the Government Printing Office Web Site - GPO 

Inet Services

http://www.access.gpo.gov/nara/cfr/cfr-table-search.html#page1
FDA Food Code 2022 Annex 2. References

Annex 2 - 2

(B) Purchasing Portions of the USC or CFR

Persons wishing to purchase relevant portions of the USC or CFR may do 

so by writing:

Superintendent of Documents (New Orders) 

U.S. Government Printing Office

P.O. Box 371954

Pittsburgh, PA 15250-7954;

Or by calling:

(202) 512-1800 from 8:00 a.m. to 5:30 p.m. eastern time 

Monday-Friday (except Federal holidays) 

Orders may be charged to Discover, MasterCard, or Visa;

Or by emailing: 

gpo@custhelp.com or

http://www.gpo.gov/customers/print.htm .

(C) USC as it Relates to the Code Definition of "Adulterated"

This language has been retyped as accurately as possible and inserted in the Food 

Code Annex for informational purposes. For legal purposes, use only language taken 

directly from the United States Code (USC).

21 USC Sec. 342

Title 21 - Food and Drugs

Chapter 9 - Federal Food, Drug and Cosmetic Act 

Subchapter IV – Food
FDA Food Code 2022 Annex 2. References

Annex 2 - 3

ADULTERATED FOOD

Sec. 402 [342] 

A food shall be deemed to be adulterated -

(a) Poisonous, insanitary, etc., ingredients 

(1) If it bears or contains any poisonous or deleterious substance which 

may render it injurious to health; but in case the substance is not an added 

substance such food shall not be considered adulterated under this clause 

if the quantity of such substance in such food does not ordinarily render it 

injurious to health.[1]1

(2)

(A) if it bears or contains any added poisonous or added deleterious 

substance (other than a substance that is a pesticide chemical residue in 

or on a raw agricultural commodity or processed food, a food additive, a 

color additive, or a new animal drug) that is unsafe within the meaning of 

section 346 of this title; or 

(B) if it bears or contains a pesticide chemical residue that is unsafe within 

the meaning of section 346a (a) of this title; or 

(C) if it is or if it bears or contains 

(i) any food additive that is unsafe within the meaning of section 348

of this title; or 

(ii) a new animal drug (or conversion product thereof) that is unsafe 

within the meaning of section 360b of this title; or 

(3) if it consists in whole or in part of any filthy, putrid, or decomposed 

substance, or if it is otherwise unfit for food; or 

(4) if it has been prepared, packed, or held under insanitary conditions 

whereby it may have become contaminated with filth, or whereby it may have 

been rendered injurious to health; or 

(5) if it is, in whole or in part, the product of a diseased animal or of an animal 

which has died otherwise than by slaughter; or 

(6) if its container is composed, in whole or in part, of any poisonous or 

deleterious substance which may render the contents injurious to health; or 

(7) if it has been intentionally subjected to radiation, unless the use of the 

radiation was in conformity with a regulation or exemption in effect pursuant 

to section 348 of this title. 

[1] So in or”. original. The period probably should be “; 
FDA Food Code 2022 Annex 2. References

Annex 2 - 4

(b) Absence, substitution, or addition of constituents 

(1) If any valuable constituent has been in whole or in part omitted or 

abstracted therefrom; or 

(2) if any substance has been substituted wholly or in part therefor; or

(3) if damage or inferiority has been concealed in any manner; or 

(4) if any substance has been added thereto or mixed or packed therewith so 

as to increase its bulk or weight, or reduce its quality or strength, or make it 

appear better or of greater value than it is. 

(c) Color additives 

If it is, or it bears or contains, a color additive which is unsafe within the meaning 

of section 379e (a) of this title. 

(d) Confectionery containing alcohol or nonnutritive substance 

If it is confectionery, and—

(1) has partially or completely imbedded therein any nonnutritive object, 

except that this subparagraph shall not apply in the case of any nonnutritive 

object if, in the judgment of the Secretary as provided by regulations, such 

object is of practical functional value to the confectionery product and would 

not render the product injurious or hazardous to health; 

(2) bears or contains any alcohol other than alcohol not in excess of one-half 

of 1 per centum by volume derived solely from the use of flavoring extracts, 

except that this clause shall not apply to confectionery which is introduced or 

delivered for introduction into, or received or held for sale in, interstate 

commerce if the sale of such confectionery is permitted under the laws of the 

State in which such confectionery is intended to be offered for sale; 

(3) bears or contains any nonnutritive substance, except that this 

subparagraph shall not apply to a safe nonnutritive substance which is in or 

on confectionery by reason of its use for some practical functional purpose in 

the manufacture, packaging, or storage of such confectionery if the use of the 

substance does not promote deception of the consumer or otherwise result in 

adulteration or misbranding in violation of any provision of this chapter, except 

that the Secretary may, for the purpose of avoiding or resolving uncertainty as 

to the application of this subparagraph, issue regulations allowing or 

prohibiting the use of particular nonnutritive substances. 

(e) Oleomargarine containing filthy, putrid, etc., matter 

If it is oleomargarine or margarine or butter and any of the raw material used 

therein consisted in whole or in part of any filthy, putrid, or decomposed 

substance, or such oleomargarine or margarine or butter is otherwise unfit for

food. 
FDA Food Code 2022 Annex 2. References

Annex 2 - 5

(f) Dietary supplement or ingredient: safety 

(1) If it is a dietary supplement or contains a dietary ingredient that—

(A) Presents a significant or unreasonable risk of illness or injury under—

(i) Conditions of use recommended or suggested in labeling, or 

(ii) If no conditions of use are suggested or recommended in the 

labeling, under ordinary conditions of use; 

(B) Is a new dietary ingredient for which there is inadequate information to 

provide reasonable assurance that such ingredient does not present a 

significant or unreasonable risk of illness or injury; 

(C) The Secretary declares to pose an imminent hazard to public health or 

safety, except that the authority to make such declaration shall not be 

delegated and the Secretary shall promptly after such a declaration initiate 

a proceeding in accordance with sections 554 and 556 of title 5 to affirm or 

withdraw the declaration; or

(D) Is or contains a dietary ingredient that renders it adulterated under 

paragraph (a)(1) under the conditions of use recommended or suggested 

in the labeling of such dietary supplement. 

In any proceeding under this subparagraph, the United States shall bear the 

burden of proof on each element to show that a dietary supplement is 

adulterated. The court shall decide any issue under this paragraph on a de 

novo basis. 

(2) Before the Secretary may report to a United States attorney a violation of 

paragraph [2] (1)(A) for a civil proceeding, the person against whom such 

proceeding would be initiated shall be given appropriate notice and the 

opportunity to present views, orally and in writing, at least 10 days before such 

notice, with regard to such proceeding. 

(g) Dietary supplement: manufacturing practices 

(1) If it is a dietary supplement and it has been prepared, packed, or held 

under conditions that do not meet current good manufacturing practice 

regulations, including regulations requiring, when necessary, expiration date 

labeling, issued by the Secretary under subparagraph (2).

[2] So in original. Probably should be “subparagraph”. 
FDA Food Code 2022 Annex 2. References

Annex 2 - 6

(2) The Secretary may by regulation prescribe good manufacturing practices 

for dietary supplements. Such regulations shall be modeled after current good 

manufacturing practice regulations for food and may not impose standards for 

which there is no current and generally available analytical methodology. No 

standard of current good manufacturing practice may be imposed unless such 

standard is included in a regulation promulgated after notice and opportunity 

for comment in accordance with chapter 5 of title 5. 

(h) Reoffer of food previously denied admission 

If it is an article of food imported or offered for import into the United States and 

the article of food has previously been refused admission under section 381 (a)

of this title, unless the person reoffering the article affirmatively establishes, at 

the expense of the owner or consignee of the article, that the article complies 

with the applicable requirements of this chapter, as determined by the Secretary. 

(As amended by Congress, 2002 – Subsec. (h). Pub. L. 107-188 added subsec. (h).) 
FDA Food Code 2022 Annex 2. References

Annex 2 - 7 

2. Bibliography

The following bibliography is a compilation of documents that were taken into 

consideration in developing the related sections of the Food Code. 

Preface

1. Archer, D.L. and J.E. Kvenberg, 1985. Incidence and cost of foodborne diarrheal 

disease in the United States. J. Food Prot. 48:887-894.

2. Center for Disease Control and Prevention (CDC), 2011. Vital Signs: Incidence 

and Trends of Infection with Pathogens Transmitted Commonly Through Food ---

Foodborne Diseases Active Surveillance Network, 10 U.S. Sites, 1996—2010. 

Morb. Mortal. Wkly. Rep. 60:1-7.

3. Committee on Salmonella, 1969. An Evaluation of the Salmonella Problem. NRC 

Pub. 1683, National Academy of Sciences, Washington, DC. 207 pp.

4. Council for Agricultural Science and Technology, 1994. Foodborne Pathogens: 

Risks and Consequences. Task Force Report No. 122, CAST, Ames, IA., 87 pp.

5. Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 374. Inspection.

6. Food and Drug Administration, January 24, 1994. Preliminary Regulatory Impact 

Analysis of the Proposed Regulations to Establish Procedures for the Safe 

Processing and Importing of Fish and Fishery Products. 

7. Food and Drug Administration. Directory of State and Local Officials. FDA/ORA 

Division of Federal-State Relations, Rockville, MD. http://www.afdo.org

8. Garthright, W.E., D.L. Archer and J.E. Kvenberg, 1988. Estimates of incidence 

and costs of intestinal infectious disease in the United States. Public Health Rep. 

103:107-115.

9. Hirsch, D., 1989. Drafting Federal Law, 2nd Ed., Office of the Legislative 

Counsel, U. S. House of Representatives, Washington, DC. 122 pp.

10.Kvenberg, J.E. and D.L. Archer, 1987. Economic impact of colonization control 

on foodborne disease. Food Technol. 41:77-98.

11.Martineau, R.J., 1991. Drafting Legislation and Rules in Plain English, University 

of Cincinnati, Cincinnati, OH. 155 pp.

12.Maryland Office of the Secretary of State, 1991. Style Manual for Maryland 

Regulations, Div. of State Documents, Annapolis, MD. 58 pp.

13.McCracken, J.B. and G.P Carver, 1992. Recommended Agency Procedures for 

Implementing Federal Metric Policy. NISTIR 4855, U.S. Department of 
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Annex 2 - 8

Commerce, National Institute of Standards and Technology, Technology 

Administration, Metric Program, Technology Services, Gaithersburg MD. 17 pp.

14.Mead, P.S., Slutsker, L., Dietz, V., McCraig, L.F., Bresee, J.S., Shapiro, C., 

Griffin, P.M., Tauxe, R.V., 1999. Food-related Illness and Death in the United 

States. Emerg. Infect. Dis. Vol. 5, No. 5, in: 

http://www.cdc.gov/ncidod/EID/vol5no5/mead.htm.

15.Metric Conversion Act of 1975, P.L. 94-168 Amended, 89 Stat. 1007; 15 U.S.C. 

§ 205a et seq.

16.Metric Systems of Measurement; Interpretation of the International System of 

Units for the United States. Notice published July 28, 1998, 63 FR 40334-40340. 

This Federal Register notice supersedes the previous interpretation published on 

December 20, 1990, 55 FR 52242-52245.

17.Omnibus Trade and Competitiveness Act of 1988, P.L. 100-418.

18.Research Triangle Institute, 1988. Estimating the Value of Consumer's Loss from 

Foods Violating the FD&C Act, FDA Contract No. 233-86-2098.

19.Scallan E, Griffin PM, Angulo FJ, Tauxe RV, Hoekstra RM., 2011. Foodborne 

Illness Acquired in the United States—Unspecified Agents. Emerg. Infect. Dis. 

Vol. 17, No.1, in: http://wwwnc.cdc.gov/eid/article/17/1/p2-1101_article.htm

20.Scallan E, Hoekstra RM, Angulo FJ, Tauxe RV, Widdowson M-A, Roy SL, et al., 

2011 Foodborne illness acquired in the United States—major pathogens. Emerg. 

Infect. Dis. Vol. 17, No. 1, in: http://wwwnc.cdc.gov/eid/article/17/1/p2-

1101_article.htm

21.The Public Health Service Act, 42 U.S.C. Section 243. General Grant of Authority 

for Cooperation. 

Chapter 1. Purpose and Definitions

1-201.10 Statement of Application and Listing of Terms

1. Americans with Disabilities Act of 1990, as Amended. 42 U.S.C. 12111 et seq.

2. Abdul-Raouf, U.M., Beuchat , L.R. and Ammar, M.S. 1993. Survival and growth 

of Escherichia coli O157:H7 on salad vegetables, Appl. Environ. Microbiol. Vol 

59, pp. 1999-2006.

3. Aruscavage, D., Lee, K., Miller, S., and LeJeune, J.T. 2006. Interactions Affecting 

the Proliferation and Control of Human Pathogens on Edible Plants. J. Food Sci. 

71(8), R89 – R99. 
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Annex 2 - 9

4. Code of Federal Regulations, Title 9, Section 362.1 Voluntary Poultry Inspection 

Regulations, Definitions. 

5. Code of Federal Regulations, Title 9, Section 354.1 Voluntary Inspection of 

Rabbits and Edible Products Thereof, Definitions. 

6. Code of Federal Regulations, Title 9, Part 301.2 Terminology; Adulteration and 

Misbranding Standards Definitions, Livestock. 

7. Code of Federal Regulations, Title 9, Section 590.5 Inspection of Eggs and Egg 

Products (Egg Products Inspection Act, Terms Defined. 

8. Code of Federal Regulations, Title 50, Part 17 Endangered and Threatened 

Wildlife and Plants. 

9. Code of Federal Regulations, Title 9, Part 381 Poultry Products Inspection 

Regulations. 

10.Code of Federal Regulations, Title 40, Part 141 National Primary Drinking Water 

Regulations. 

11.Code of Federal Regulations, Title 40, Part 152.175 Pesticides classified for 

restricted use. 

12.Corby, R., Lanni, V. , Kistler, V. , Dato, V. , Yozviak, C., Waller, K., Nalluswami, 

K., Moll, M., Center for Food Safety and Applied Nutrition, Office of Crisis 

Management, Food and Drug Admin., J. Lockett, S. Montgomery, M. Lynch, C. 

Braden, S.K. Gupta and A. DuBois. 2005. Outbreaks of Salmonella Infections 

Associated with Eating Roma Tomatoes --- United States and Canada, 2004 

MMWR, April 8, 2005, 54(13): 325-328.

13.Delaquis, P., Steward, S., Cazaux, S., and Toivonen, P. 2002. Survival and 

Growth of Listeria monocytogenes and Escherichia coli O157:H7 in Ready-to-Eat 

Iceberg Lettuce Washed in Warm Chlorinated Water, J. Food Protect. 65(3): 459-

464.

14.Doerry, W.T., 1996. Shelf-Stable Pumpkin Pies. A research report, American 

Institute of Baking, Manhattan, KS. 

15.Federal Food, Drug and Cosmetic Act, 21 U.S.C. 321 Definitions (s) Food 

Additive, and Code of Federal Regulations, and Title 21 Part 170 Food Additives. 

16.Federal Food, Drug and Cosmetic Act, 21 U.S.C. 321 Definitions (t) Color 

Additive, and Code of Federal Regulations, and Title 21 Part 70 Color Additives. 

17.Federal Food, Drug and Cosmetic Act, 21 U.S.C. 342 Adulterated Food. 
FDA Food Code 2022 Annex 2. References

Annex 2 - 10

18.Federal Food, Drug and Cosmetic Act, 21 U.S.C. 379e (a) Unsafe Color 

Additives. 

19.Federal Register: May 7, 2001 (Volume 66, Number 88), Rules and Regulations, 

Pages 22899-22907, DEPARTMENT OF AGRICULTURE, Food Safety and 

Inspection Service, 9 CFR Parts 362 and 381, Docket No. 01-045IF, RIN 0583-

AC84, Mandatory Inspection Ratites and Squabs. 

https://www.federalregister.gov/documents/2001/05/07/R1-10679/mandatoryinspection-of-ratites-and-squabs

20.Food Allergen Labeling and Consumer Protection Act of 2004. Public Law 

108-282 https://www.fda.gov/food/food-allergensgluten-free-guidancedocuments-regulatory-information/food-allergen-labeling-and-consumerprotection-act-2004-falcpa

21.Food Allergy Safety, Treatment, Education, and Research (FASTER) Act of

2021. Public Law 117-11. https://www.congress.gov/117/plaws/publ11/PLAW117publ11.pdf

22.Food and Drug Administration/U. S. Public Health Service, 2020. National 

Shellfish Sanitation Program. 

http://www.fda.gov/Food/GuidanceRegulation/FederalStateFoodPrograms/ucm2

006754.htm

23.Food and Drug Administration/U. S. Public Health Service, 2019 revision. Grade 

"A" Pasteurized Milk Ordinance. https://www.fda.gov/media/140394/download

24.Guo, X., Chen, J., Brackett, R.E., and Beuchat, L.R. 2001. Survival of 

Salmonellae on and in Tomato Plants from the Time of Inoculation at Flowering 

and Early Stages of Fruit Development through Fruit Ripening. Appl. and 

Environ. Microbiol. 67(10): 4760-4764.

25.Institute of Food Technologists (IFT) Report, Evaluation and Definition of 

Potentially Hazardous Foods, Food and Drug Administration Contract No. 223-

98-2333, Task Order No. 4, December 31, 2001. 

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26.Koseki, S. and Isobe, S. 2005. Prediction of pathogen growth on iceberg lettuce 

under real temperature history during distribution from farm to table. Int. J. of 

Food Microbiol. (104) 239-248.

27.Laine, E.S., J.M. Scheftel, D.J. Boxrud, K.J. Vought, R.N. Danila, K.M. Elfering 

and K.E. Smith. 2005. Outbreak of Escherichia coliO157:H7 Infections 

Associated with Nonintact Blade-Tenderized Frozen Steaks Sold by Door-toDoor Vendors. J. Food Protect. 68(6): 1198-1202.
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28.Li, Y., Brackett, R.E., Chen, J., and Beuchat, L.R. 2001. Survival and Growth of 

Escherichia coli O157:H7 Inoculated onto Cut Lettuce Before or After Heating in 

Chlorinated Water, Followed by Storage at 5 or 15oC, J. Food Protect. 64(3): 

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29.Marsden, J.L., R.K. Phebus, H. Thippareddi, C.L. Kastner and J.B. Bosch. 2001. 

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30.National Advisory Committee on Microbiological Criteria for Foods, 1998. Hazard 

Analysis and Critical Control Point System. J. Food Prot. 61(9);1246-1259. 

31.Program Information Manual entitled, “Retail Food Protection: Storage and 

Handling of Tomatoes”, 2007. See

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32.Wachtel, M.R. and A.O. Charkowski. 2002. Cross-Contamination of Lettuce with 

Escherichia coli O157:H7, J. Food Protect. 65(3): 465-470. 

33.Yaguang Luo*, Qiang He, James L. McEvoy, and William S. Conway. 2009. Fate 

of Escherichia coli O157:H7 in the Presence of Indigenous Microorganisms on 

Commercially Packaged Baby Spinach as Impacted by Storage Temperature 

and Time. Journal of Food Protection 72 (10): 2038-2045.

34.Zhuang, R.Y., L.R. Beuchat and F.J. Angulo. 1995. Fate of Salmonella

Montevideo on and in Raw Tomatoes as Affected by Temperature and Treatment 

with Chlorine. Appl. and Environ. Microbiol. 61(6):2127-2131.

Chapter 2. Management and Personnel

2-102.11 Demonstration.

1. Bean, N.H. and P.M. Griffin, 1990. Foodborne disease outbreaks in the United 

States, 1973-1987: pathogens, vehicles, and trends. J. Food Prot. 53:804-817.

2. Bryan, F.L., 1979. Prevention of foodborne diseases in food service 

establishments. J. Environ. Health 41:198-206.

3. Bryan, F.L., 1988a. Risks associated with vehicles of foodborne pathogens and 

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4. Bryan, F.L., 1988b. Risks of practices, procedures and processes that lead to 

outbreaks of foodborne diseases. J. Food Prot. 51(8): 663-673.

5. Doyle, M.P., 1991. Escherichia coli O157:H7 and its significance in foods. Int. J. 

Food Microbiol. 12:289-302. 
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6. Liston, J., 1990. Microbial hazards of seafood consumption. Food Technol. 

44(12):56, 58-62.

7. World Health Organization, 1989. Health Surveillance and Management 

Procedures for Food-handling Personnel, Technical Report Series 785, WHO, 

Geneva, Switzerland. 50 pp. 

2-102.12 Certified Food Protection Manager. 

Amend References to add new §2-102.12, Certified Food Protection Manager, to 

add references to read as follows:

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2. U.S. Food and Drug Administration. 2004. FDA Report on the Occurrence of 

Foodborne Illness Risk Factors in Selected Institutional Food Service, 

Restaurant, and Retail Food Store Facility Types (2004). Available at 

https://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/FoodborneIl

lnessRiskFactorReduction/default.htm

3. U.S. Food and Drug Administration. 2009. FDA Report on the Occurrence of 

Foodborne Illness Risk Factors in Selected Institutional Foodservice, Restaurant, 

and Retail Food Store Facility Types (2009). Available at 

https://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/FoodborneIl

lnessRiskFactorReduction/default.htm

2-201.11 Responsibility of the Person in Charge, Food Employees, and 

Conditional Employees. 

2-201.12 Exclusions and Restrictions.

1. Americans with Disabilities Act of 1990, as Amended. 42 U.S.C. 12111 et seq.

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Viruses, the Human Caliciviruses. Clinical Microbiology Reviews. Vol. 14, No. 1, 

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Thomas, S Zansky, KE Fullerton, OL Henao, E Scallan, FoodNet Working Group. 

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8. Caul, E.O., 1994. Small round structured viruses: airborne transmission and 

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11.Centers for Disease Control and Prevention, March 1, 2017, update of annual list 

of Pathogens Transmitted by Food Contaminated by Infected Persons Who 

Handle Food, and Modes of Transmission of Such Pathogens, found at 

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12.Centers for Disease Control and Prevention. CDC Health Information for 

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13.Centers for Disease Control and Prevention. Surveillance for Foodborne Disease 

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Foodborne Disease Outbreaks – United States, 2009-2010, found at 

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_w
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17.Chadwick, P.R. and R. McCann, 1994. Transmission of a small round structured 

virus by vomiting during a hospital outbreak of gastroenteritis. Journal of Hospital 

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18.Code of Federal Regulations, Title 29, Part 1630 Regulations to Implement the 

Equal Employment Provisions of the Americans with Disabilities Act. 

19.Colorado Department of Health, 1993. Public Health Handbook For Management 

Of Acute Hepatitis A. Division of Disease Control and Environmental 

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23.Equal Employment Opportunity Commission, 2004. How to Comply with the 

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24.Ethelberg, S., M. Lisby, M. Torpdahl, G. Sorensen, J. Neimann, P. Rasmussen, 

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the United States. J. Infect. Dis. 178:1571-15788. 

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27.Grahm, D.Y., X. Jiang, et al., 1994. Norwalk virus infection of volunteers: new 

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29.Green, L., C. Selman, A. Banerjee, R. Marcus, C. Medus, F. J. Angulo, V. Radke, 

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Health 208:27-35. 

30.Green, L. R., C. A. Selman, V. Radke, D. Ripley, J. C. Mack, D. W. Reimann, T. 

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practices: an observation study. J. Food Prot. 69:2417-2423. 

31.Greenberg, H.B., R.G. Wyatt and A.Z. Kapikian, 1979. Norwalk virus in vomitus. 

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32.Griffin, P.M. and R.V. Tauxe, 1991. The epidemiology of infections caused by 

Escherichia coli O157:H7, other enterohemorrhagic E. coli, and the associated 

hemolytic uremic syndrome. Epidemiol. Rev. 13:60-98. 

33.Hedberg, C. W., K. E. White, J. A. Johnson, L. M. Edmonson, J. T. Soler, J. A. 

Korlath, L. S. Theurer, K. L. MacDonald, and M. T. Osterholm. 1991. An outbreak 

of Salmonella enteritidis infection at a fast-food restaurant: implications for 

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34.Hedican, E., C. Hooker, T. Jenkins, C. Medus, S. Jawahir, F. Leano, and K. 

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35.Heymann, David L. MD, (Ed.), 2008. Control of Communicable Diseases Manual, 

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40.Lopman, B.A., et. al., 2002. Human caliciviruses in Europe. Journal of Clinical 

Virology. Vol. 24, Issue 3, pp. 137-160. 
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Control and Prevention. Surveillance for foodborne-disease outbreaks-United 

States, 1998-2002. MMWR Surveill. Summ. 55(SS10):1-42.

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Chambers. 2000. Hospital outbreak of Salmonella Virchow possibly associated 

with a food handler. J. Hosp. Infect. 44: 261-266. 

43.Matsui, S.M., and H.B. Greenberg, 2000. Immunity to calicivirus infection. The 

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45.Mead, P.S., L. Slutsker, V. Dietz, L.F. McCraig, J.S. Bresee, C. Shapiro, P.M. 

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46.Medus, C., K. E. Smith, J. B. Bender, J. M. Besser, and C. W. Hedberg. 2006. 

Salmonella outbreaks in restaurants in Minnesota, 1995 through 2003: evaluation 

of the role of infected foodworkers. J. Food Prot. 69:1870-1878. 

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54.Soper, G.A., 1939. The curious career of Typhoid Mary. Bull. N.Y. Acad Med. 

15:698-712. 

55.Tauxe, R.V., K.E. Johnson, J.C. Boase, S.D. Helgerson and P.A. Blake, 1986. 

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57.Todd, ECD, JD Greig, CA Bartelson, and BS Michaels. 2007a. Outbreaks Where 

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59.U.S. Department of Health and Human Services. Healthy People 2010: 

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2-201.13 Removal, Adjustment, or Retention of Exclusions and Restrictions. 

1. Code of Federal Regulations, Title 21, Section 110.10 Personnel. (a) Disease 

Control. " Any person who, by medical examination or supervisory observation is 

shown to have, or appears to have, an illness, ... shall be excluded from any 

operations which may be expected to result in contamination, ... Personnel shall 

be instructed to report such health conditions to their supervisors." 

2. Equal Employment Opportunity Commission, 2004. How to Comply with the 

Americans with Disabilities Act: A Guide for Restaurants and Other Food Service 

Employers, found at http://www.eeoc.gov/facts/restaurant_guide.html or 

http://www.eeoc.gov/facts/restaurant_guide_summary.html . 

3. Heymann, David L. MD, (Ed.), 2008. Control of Communicable Diseases Manual, 

19th Ed., American Public Health Association, Washington D.C.
FDA Food Code 2022 Annex 2. References

Annex 2 - 18

4. Lee, L.A., C.N. Shapiro, N. Hargrett-Bean and R.V. Tauxe, 1991. Hyperendemic 

Shigellosis in the United States: A review of surveillance data for 1967-1988. J. 

Infect. Dis. 164:894-900. 

5. Ryder, R.W. and P.A. Blake, 1979. Typhoid fever in the United States, 1975 and 

1976. J. Infect. Dis. 139:124-126. 

2-301.12 Cleaning Procedure. (Handwashing)

1. Ansari, S. A., Springthorpe, V. S., Sattar, S. A., Tostowaryk, W., and Wells, G. 

A., 1991. Comparison of cloth, paper, and warm air drying in eliminating viruses 

and bacteria from washed hands. Am. J. Infect. Cont., Vol.19. No. 5. pp. 243-

249. 

2. Ansari, S. A, Sattar, S. A., S., V. S., Wells, G. A. and Tostowaryk, W., 1989. In 

Vivo Protocol for Testing Efficacy of Hand-Washing Agents against Viruses and 

Bacteria: Experiments with Rotavirus and Escherichia coli. Appl. Environ. 

Microbiol., Vol. 55, No. 12. pp. 3113-3118. 

3. Ansari, S. A., Sattar, S. A., Springthorpe, V. S., Wells, G. A., and Tostowaryk, 

W., 1988. Rotavirus Survival on Human Hands and Transfer of Infectious Virus to 

Animate and Nonpourous Inanimate Surfaces, J. Clin. Microbiol., Vol. 26, No. 8. 

pp.1513-1518. 

4. Ayliffe, G.A.J., Babb, J.R., Davies, J.G., and Lilly, H.A., 1988. Hand disinfection: 

a comparison of various agents in laboratory and ward studies. J. Hosp. Infect., 

Vol. 11, pp. 226-243. 

5. Ayliffe, G.A.J., Babb, J.R., and Quoraishi, A.H., 1978. A test for ‘hygienic’ hand 

disinfection. J. Clin. Path., Vol. 31, pp. 923-928. 

6. Bellamy, K., Alcock, R., Babb, J.R., Davies, J.G., and Ayliffe, G.A.J. 1993. A test 

for the assessment of ‘hygienic’ hand disinfection using rotavirus. J. Hosp. 

Infect., Vol. 24, pp. 201-210. 

7. Casewell, M., Phillips, I., 1977. Hands as route of transmission for Klebsiella 

species. Brit. Med. J. Vol. 2, No.19. pp.1315-1317. 

8. Cliver, D. O., and Kostenbader, K. D., 1984. Disinfection of virus on hands for 

prevention of food-borne disease. Intern. J. Food Microbiol., Vol. 1, pp. 75-87. 

9. De Witt, J.C. 1985. The importance of hand hygiene in contamination of foods. 

Netherlands Society for Microbiology, section for food microbiology meeting at 

Ede on 24 May, 1984. Antonie von Leeuwenhoek, Vol. 51, pp. 523-527. 

10.Eckert, D.G., Ehrenkranz, N.J., Alfonso, B.C. 1989. Indications for alcohol or 

bland soap in removal of aerobic gram-negative skin bacteria: assessment by a 

novel method. Infect. Control Hosp. Epidemiol., Vol. 10, pp. 306-311. 
FDA Food Code 2022 Annex 2. References

Annex 2 - 19

11.The National Restaurant Association Educational Foundation (NRAEF), 2004. 

The Safe Foodhandler, in ServSafe Essentials, 3rd Ed., NRAEF, Chicago, IL 

pages 4-1 – 4-25. 

12.Eggers, H. J. 1990. Experiments on Antiviral Activity of Hand Disinfectants. 

Some Theoretical and Practical Considerations. Zbl. Bakt. Vol.273, pp.36-51. 

13.Ehrenkranz, N.J., 1992. Bland soap handwash or hand antisepsis? The pressing 

need for clarity. Infect. Control Hosp. Epidemiol., Vol. 13, No. 5, pp. 299-301. 

14.Ehrenkranz, N.J., Alfonso, B., 1991. Failure of bland soap handwash to prevent 

hand transfer of patient bacteria to urethral catheters. Infect. Control Hosp. 

Epidemiol. Vol. 12, No. 11, pp. 654-662. 

15.Garner, J.S. and M.S. Favero, 1985. Guidelines for Handwashing and Hospital 

Environmental Control. Hospital Infections Program, Center for Infectious 

Diseases, CDC, Atlanta, GA. pp. 7-9. 

16.Kjolen H., and Andersen, B. M., 1992. Handwashing and disinfection of heavily 

contaminated hands – effective or ineffective? J. Hosp. Infect., Vol. 21, pp. 61-

71. 

17.Lane, C.G., and Blank, I.H., 1942. Cutaneous Detergents. J.A.M.A. 118 (10): 

804-816. 

18.Larson, E.L., 1995. APIC Guideline for handwashing and hand antisepsis in 

health care settings, American J. Infect. Control, Vol. 23, No. 4, pp. 251-269. 

19.Lilly, H.A, Lowbury, E.J.L. 1978. Transient skin flora. Their removal by cleansing 

or disinfection in relation to their mode of deposition. J. Clin. Path. Vol. 31, pp. 

919-922. 

20.Mbithi, J.N., Springthorpe, S., and Sattar, S., 1993. Comparative in vivo 

efficiencies of hand-washing agents against Hepatitis A virus (HM-175) and 

Poliovirus Type 1 (Sabin). Applied Environ Microbiol. Vol.59, No.10, pp. 3463-

3469. 

21.McGinley, K.J., Larson, E.L., and Leyden, J.J. 1988. Composition and Density of 

Microflora in the Subungual Space of the Hand. J. of Clin. Micro. 26(5): 950-953. 

22.Minnesota Department of Health, 1990. Guidelines for the Prevention of the 

Transmission of Viral Hepatitis, Type A in the Food Service Area. Minnesota 

Department of Health, Div. Environ. Health, Minneapolis, MN. 2 pp. 

23.Paulson, D.S., 1992. Evaluation of three handwashing modalities commonly 

employed in the food processing industry. Dairy Food Environ. Sanit. 12(10):615-

618. 
FDA Food Code 2022 Annex 2. References

Annex 2 - 20

24.Pether, J.V.S., and Gilbert, R.J., 1971. The survival of salmonellas on finger-tips 

and transfer of the organism to foods. J. Hyg. Vol. 69, pp. 673-681. 

25.Price, P.B., 1938. The Bacteriology of Normal Skin; A New Quantitative Test 

Applied to a Study of the Bacterial Flora and the Disinfectant Action of 

Mechanical Cleansing, J. Infect. Dis. 63: 301-318. 

26.Restaino, L. and Wind, C.E., 1990. Antimicrobial effectiveness of hand washing 

for food establishments. Dairy, Food and Environ. San. Vol.10, No. 3, pp.136-

141. 

27.Reybrouck, G., 1986. Handwashing and hand disinfection. J. Hosp. Infect. 8: 5-

23. 

28.Rotter, M.L., G.A.J. Ayliffe, 1991. Practical Guide on Rationale and Testing 

Procedures for Disinfection of Hands. World Health Organization. 57 pp. 

29.Rotter, M.L., Koller, W., 1991. An European test for the evaluation of the efficacy 

of procedures for the antiseptic handwash? Hyg. Med., Vol. 16, pp.4-12. 

30.Rose, J.B., and Slifko, T.R., 1999. Giardia, Cryptosporidium, and Cyclospora and 

their impact on foods: a review. J. Food Protect. Vol. 62., No. 9, pp. 1059-1070. 

31.Sattar, S.A., and Springthorpe, V.S. 1996. Environmental spread and germicide 

control of viruses in hospitals. Infect Control & Steril.Tech, Vol. 2, no.7, pp. 30-

36. 

32.Schurmann, W., and Eggers, H.J. 1985. An experimental study on the 

epidemiology of enteroviruses: water and soap washing of poliovirus 1 –

contaminated hands, its effectiveness and kinetics. Med. Microbiol. Immunol. Vol. 

174, pp. 221-236. 

33.Smith, G.A., Jr, 1991. Handwashing et cetera, Lexington Board of Health, 

Personal Hygiene Sanitation Programs, Lexington, KY. 2 pp. 

34.Stiles, M.E., and Sheena, A.Z. 1987. Efficacy of Germicidal Hand Wash Agents 

in Use in a Meat Processing Plant. J. Food Protect. 50 (4):289-295. 

35.Sprunt, Katherine, Redman, Winifred, and Leidy, Grace, 1973. Antibacterial 

Effectiveness of Routine Hand Washing. Pediatrics, Vol. 52, No. 2, pp. 264-271. 

36.Williams, R.E.O., 1963. Healthy carriage of Staphylococcus aureus: Its 

prevalence and importance. Bacteriol. Rev. 27:56-71. 

2-301.13 Special Handwashing Procedures.

Reserved. 
FDA Food Code 2022 Annex 2. References

Annex 2 - 21

2-301.14 When to Wash.

1. Ojajarvi, J., 1980. Effectiveness of handwashing and disinfection methods in 

removing transient bacteria after patient nursing. J. Hyg. Camb. 85:193-203. 

2-301.16 Hand Antiseptics. 

2. Code of Federal Regulations, Title 21, Part 178.1010 Sanitizing Solutions

3. Code of Federal Regulations, Title 21, Part 170.39 Threshold of Regulation for 

Substances Used in Food-Contact Articles. 

4. Code of Federal Regulations, Title 21, Part 182 Substances Generally 

Recognized as Safe. 

5. Code of Federal Regulations, Title 21, Part 184 Direct Food Substances Affirmed 

as Generally Recognized as Safe. 

6. Code of Federal Regulations, Title 21, Part 186 Indirect Food Substances 

Affirmed as Generally Recognized as Safe for Use in Contact with Food. 

7. Federal Register (59) No. 116, June 17, 1994, Tentative Final Monograph (TFM) 

for Health Care Antiseptic Drug Products; Proposed Rule. Page 31440. 

http://www.gpo.gov/fdsys/pkg/FR-1994-06-17/html/94-14503.htm

8. Food and Drug Administration, Center for Drug Evaluation and Research, Office 

of Pharmaceutical Science, Office of Generic Drugs, 2009. Approved Drug 

Products with Therapeutic Equivalence Evaluations (the Orange Book). 

http://www.fda.gov/cder/ob/default.htm. 

9. Food and Drug Administration. 2009. Inventory of Effective Food Contact 

Substance (FCS) Notifications. CFSAN/Office of Food Additive Safety. Found at 

http://www.accessdata.fda.gov/scripts/fcn/fcnNavigation.cfm?rpt=fcsListing

10.Food and Drug Administration. FDA’s Inventory of GRAS Notices. Found at 

http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/d

efault.htm

11.Food and Drug Administration, January, 2005. Investigations Operations Manual, 

Chapter 5, Establishment Inspection, Subchapter 530, Food Section 534, 

Equipment and Utensils. 

12.Stiles, M.E. and A.Z. Sheena, 1987. Efficacy of germicidal hand wash agents in 

use in a meat processing plant. J. Food Prot. 50(4): 289-294.
FDA Food Code 2022 Annex 2. References

Annex 2 - 22

2-302.11 Maintenance. (Fingernails)

1. Pether, J.V.S. and R.J. Gilbert, 1971. The survival of salmonellas on finger-tips 

and transfer of the organisms to foods. J. Hyg. Camb. 69:673-681. 

2. Pottinger, J., S. Burns, and C. Manake, 1989. Bacterial carriage by artificial 

versus natural nails. Am. J. Infect. Control, 17(6):340-344. 

2-303.11 Prohibition. (Jewelry)

2-304.11 Clean Condition. (Outer Clothing)

2-401.11 Eating, Drinking, or Using Tobacco Products.

2-402.11 Effectiveness. (Hair Restraints)

1. Code of Federal Regulations, Title 21, Sections 110.10 Personnel. (b) (1) 

"Wearing outer garments suitable to the operation ...." (4) "Removing all 

unsecured jewelry ...." (6) "Wearing, where appropriate, in an effective manner, 

hair nets, head bands, caps, beard covers, or other effective hair restraints." (8) 

"Confining...eating food, chewing gum, drinking beverages or using tobacco...." 

and (9) "Taking other necessary precautions ...." 

2-403.11 Handling Prohibition. (Animals)

1. Bond, R., L.E.M. Saijonmaa-Koulumies, and D.H. Lloyd, 1995. Population sizes 

and frequency of Malassezia pachydermatis at skin and mucosal sites on 

healthy dogs. J. Small Animal Pract. 36: 147-150. 

2. Code of Federal Regulations, Title 21, Section 110.35(c). 

3. Food and Drug Administration, 1985. Premises - Acceptability of pets in common 

dining areas of group residences (5/17/85). Retail Food Protection Program 

Information Manual. 

4. Hirooka, Elisa Y., Ernest E. Muller, Julio C. Freitas, Eduardo Vicente, Yuko 

Yoshimoto, and Merlin S. Bergdoll. 1988. Enterotoxigenicity of Staphylococcus 

intermedius of canine origin. Int. J. Food Micro. 7: 185-191. 

5. Khambaty, F.M., R.W. Bennett, and D.B. Shah. 1994. Application of pulsed-field 

gel electrophoresis to the epidemiological characterization of Staphylococcus 

intermedius implicated in a food-related outbreak. Epidemiol. Infect. 133: 75-81.

2-501.11 Clean-up of Vomiting and Diarrheal Events.

Amend References to add new §2-501.11, Clean-up of Vomiting and Diarrheal 

Events, to add references to read as follows:
FDA Food Code 2022 Annex 2. References

Annex 2 - 23

1. Barker, J., Vipond, I.B., Bloomfield, S.F. 2004. Effects of cleaning and 

disinfection in reducing the spread of Norovirus contamination via environmental 

surfaces. J. of Hospital Infection (2004) 58, 42-49.

2. Barker, J., Jones. M.V. 2005. The potential spread of infection caused by aerosol 

contamination of surfaces after flushing a domestic toilet. J. of Applied 

Microbiology 99: 339-347.

3. Center for Disease Control and Prevention (CDC). 2011. Updated Norovirus 

Outbreak Management and Disease Prevention Guidelines. 2011. MMWR 

60(RR03);1-15.

4. Center for Disease Control and Prevention (CDC). 2009. Surveillance for 

Foodborne Disease Outbreaks – United States, 2006. MMWR 58(22); 609-615.

5. Center for Disease Control and Prevention (CDC). 2007. Norovirus Activity –

United States, 2006-2007. MMWR 58(33); 842-846.

6. Center for Disease Control and Prevention (CDC). 2006. Norovirus Technical 

Fact Sheet. http://www.cdc.gov/norovirus/hcp/index.html

7. Center for Disease Control and Prevention (CDC) 2006. Norovirus in Health care 

Facilities Fact Sheet. http://www.cdc.gov/hai/pdfs/norovirus/229110-

ANoroCaseFactSheet508.pdf

8. Center for Disease Control and Prevention (CDC). 2009. Recurring Norovirus 

Outbreaks in a Long-Term Residential Treatment Facility –Oregon, 2007. MMWR 

58(25); 694-698.

9. Caul, E.O. 1994. Small round structured viruses: airborne transmission and 

hospital control. Lancet 343: 1240-1242.

10.Cheesebrough, J.S., J. Green, C.I. Gallomore, P.A. Wright, and D.W.G. Brown. 

2000. Widespread environmental contamination with Norwalk-like viruses (NLV) 

detected in a prolonged hotel outbreak of gastroenteritis. Epidemiol. Infect. 

125:93-98.

11.Duret, S., Pouillot, R., Fanaselle, W., Papafragkou, E., Liggans, G., Williams, L., 

and J.M. Van Doren. 2017. Quantitative risk assessment of Norovirus 

transmission in food establishments: Evaluating the impact of intervention 

strategies and food employee behavior on the risk associated with Norovirus in 

foods. Risk Analysis. 37: 2080-2106.

12.Fanaselle, W., Pouillot, R., Papafragkou, E., Liggans, G., Williams, L., and J.M. 

Van Doren. 2022. Evaluation of the impact of compliance with mitigation 

strategies and frequency of food establishment surface cleaning/sanitizing to 

control the transmission of Norovirus from ill food employees in restaurants using 
FDA Food Code 2022 Annex 2. References

Annex 2 - 24

an existing quantitative risk assessment model. https://doi.org/10.4315/ JFP-21-

423.

Chapter 3. Food

3-201.11 Compliance with Food Law. 

1. Centers for Disease Control, 1987. International outbreak associated with 

ungutted, salted whitefish. Morb. Mortal. Wkly. Rep. 36:812-813. 

2. Code of Federal Regulations, Title 21, Part 16, Regulatory Hearing Before the 

Food and Drug Administration. 

3. Code of Federal Regulations, Title 21, Part 101, Food Labeling. 

4. Code of Federal Regulations, Title 21, Part 115, Shell Eggs. 

5. Federal Register: (Volume 65, Number 234), Pages 76091-76114. 

6. Goverd, K.A., F.W. Beech, R.P. Hobbs and R. Shannon, 1979. The occurrence

and survival of coliforms and salmonellas in apple juice and cider. J. Appl. 

Bacteriol. 46:521-530. 

7. Zhao, T., M.P. Doyle and R.E. Besser, 1993. Fate of enterohemorrhagic 

Escherichia coli O157:H7 in apple cider with and without preservatives. Appl. 

Environ. Microbiol. 59(8): 2526-2530. 

3-201.12 Food in a Hermetically Sealed Container.

1. Code of Federal Regulations, Title 21, Parts 108 - Emergency Permit Control, 

113 - Thermally Processed Low-acid Foods Packaged in Hermetically Sealed 

Containers, and 114 - Acidified Foods. 

3-201.13 Fluid Milk and Milk Products.

1. Black, R.E., R.J. Jackson, T. Tsai, M. Medvesky, M. Shaygani, J.C. Feely, K.I.E. 

MacLeod and A.M. Wakelee, 1978. Epidemic Yersinia enterocolitica infection 

due to contaminated chocolate milk. N. Engl. J. Med. 298:76-79. 

2. Food and Drug Administration/U.S. Public Health Service Publication No. 229, 

2007 revision. Grade “A” Pasteurized Milk Ordinance. 2007. 

http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInf

ormation/Milk/ucm2007968.htm
FDA Food Code 2022 Annex 2. References

Annex 2 - 25

3. Potter, M.E., A.F. Kauffmann, P.A. Blake and R.A. Feldman, 1984. 

Unpasteurized milk: The hazards of a health fetish. J. Am. Med. Assoc. 

252:2048-2052. 

3-201.14 Fish.

1. Code of Federal Regulations, Title 21, Part 123 Fish and Fishery Products. 

2. Code of Federal Regulations, Title 21, Part 101.17(h) Food labeling warning 

notice, and safe handling statement. 

3. Code of Federal Regulations, Title 9, Part 317.2(l) Labels: definition; required 

features.

4. Code of Federal Regulations, Title 9, Part 381.125(b) Special handling label 

requirements.

5. Engleberg, N.C., J.G. Morris, Jr., J. Lewis, J.P. McMillan, R.A. Pollard and P.A. 

Blake. 1983. Ciguatera fish poisoning: a major common source outbreak in the 

U.S. Virgin Islands. Ann. Intern. Med. 98:336-337. 

6. EPA Annual National Listing of Fish Advisories and Press Release, March 2004, 

EPA-823-R-04-005, August 24, 2004, EPA Releases 12th Annual National Listing 

of Advisories at http://www.epa.gov/waterscience/fish/advisories/index.html

7. EPA Press Release, March 2004, EPA-823-R-04-005, What You Need to Know 

About Mercury in Fish and Shellfish, 2004 EPA and FDA Advice For: Women 

Who Might Become Pregnant, Women Who are Pregnant, Nursing Mothers,

Young Children at 

http://www.epa.gov/waterscience/fish/MethylmercuryBrochure.pdf or 

http://www.epa.gov/waterscience/fishadvice/advice.html

8. EPA Technical Fact Sheet, EPA-823-F-04-016, August 2004. National Listing of 

Fish Advisories. http://www.epa.gov/waterscience/fish/advisories/factsheet.pdf

9. Liston, J. 1990. Microbial hazards of seafood consumption. Food Technol. 

44(12):56, 58-62.

10.Morris, J.G., Jr. 1988. Vibrio vulnificus: A new monster of the deep? Ann. Intern. 

Med. 109:261-263. 

11.Taylor, S.L. 1986. Histamine food poisoning: Toxicology and clinical aspects. 

C.R.C. Crit. Rev. Toxicol. 17:91-128.
FDA Food Code 2022 Annex 2. References

Annex 2 - 26

3-201.15 Molluscan Shellfish.

1. Food and Drug Administration, Center for Food Safety and Applied Nutrition, 

2019. National Shellfish Sanitation Program Guide for the Control of Molluscan 

Shellfish found at https://www.fda.gov/food/federalstate-food-programs/nationalshellfish-sanitation-programnssp#:~:text=The%20National%20Shellfish%20Sanitation%20Program,and%20s

old%20for%20human%20consumption 

2. Guzewich, J.J. and D.L. Morse, 1986. Sources of shellfish in outbreaks of 

probable viral gastroenteritis: Implications for control. J. Food Prot. 49:389-394.

3. Sobsey, M.D., C.R. Hackney, R.J. Carrick, B. Ray and M.C. Speck, 1980. 

Occurrence of enteric bacteria and viruses in oysters. J. Food Prot. 43:111-128. 

3-201.16 Wild Mushrooms.

1. Ammirati, J.F. et al., 1985. Poisonous Mushrooms of the Northern United States 

and Canada, University of Minnesota Press, Minneapolis, MN. 

2. Associated Press, 1997 Cable News Network, Inc. CNN report: poisonous 

mushrooms kill Sebastiani wine family member, January 16, 1997. 

3. Baltimore Sun Newspaper via Associated Press, February 9, 1996 report on girl 

who picked deadly mushrooms with family gets liver transplant. 

4. Chang, S.T. and W.A. Hayes, 1978. The Biology and Cultivation of Edible 

Mushrooms. Academic Press, New York. 819 pp. 

5. Food and Drug Administration, 1987. Food Supplies - Wild mushrooms (6/11/87). 

Retail Food Protection Program Information Manual. 

6. Gecan, J.S., and S.M. Cichowicz. 1993. Toxic mushroom contamination of wild 

mushrooms in commercial distribution. J. Food Prot. 56(8):730-734. 

7. Hoard, R. and K. Hoard, 1980. Poisonous Hallucinogenic Mushrooms, 2nd Ed., 

Homestead Books, Brookfield, NY. 164 pp. 

8. Lincoff, G. and D. Mitchel, 1977. Toxic and Hallucinogenic Mushroom Poisoning, 

Van Nostrand Reinhold Company, New York, 267 pp. 

3-201.17 Game Animals.

1. Code of Federal Regulations, Title 50, Part 17 Endangered and Threatened 

Wildlife and Plants. 

2. Code of Federal Regulations, Title 9, Part 352 Exotic animals; voluntary 

inspection of rabbits. 
FDA Food Code 2022 Annex 2. References

Annex 2 - 27

3. Code of Federal Regulations, Title 9, Part 354 Voluntary inspection of rabbits and 

edible products thereof. 

4. Codex Alimentarius Commission, 1993. Draft Revised Code of Hygienic Practice 

for Game (April 1993). Alinorm 93/16A, Appendix IV, pp. 119-149. 

5. Federal Food, Drug, and Cosmetic Act, as Amended. 21 U.S.C. 201 et seq. 

6. Federal Meat Inspection Act. 21 U.S.C. 601 et seq. 

7. Hogue, A.T., D.W. Dreesen, S.S. Greene, A.D. Ragland, W.O. James, E.A. 

Bereron, L.V. Cook, M.D. Pratt, and D.R. Martin, 1993. Bacteria on beef briskets 

and ground beef: correlation with slaughter volume and antemortem 

condemnation. J. Food Prot. 56(2): 110-113, 119. 

8. Poultry Products Inspection Act. 21 U.S.C. 451 et seq. 

3-202.11 Temperature.

1. Code of Federal Regulations, Title 9, Part 590 Egg Products Inspection Act, 

Temperature and labeling requirements.

2. Humphrey, T.J., 1994. Contamination of egg shell and contents with Salmonella

enteriditis: a review. International Journal of Food Microbiology, 21(1994) 31-40.

3. Mishu, B., J. Koehler, L. Lee, D. Rodrigue, F. Hickman Brenner, P. Blake, and R. 

Tauxe, 1994. Outbreaks of Salmonella enteritidis infections in the United 

States, 1985-1991. J. Infect. Dis. 169:547-552.

4. Rosenow, E.M. and E.H. Marth, 1987. Growth of Listeria monocytogenes in 

skim, whole and chocolate milk, and in whipping cream during incubation at 

4,8,13,21 and 35o C. J. Food Prot. 50:452-259. 

5. St. Louis, M.E., D.L. Morse, M.E. Potter, et al., 1988. The emergence of Grade A 

eggs as a major source of Salmonella enteritidis infections: New implications 

for the control of salmonellosis. J. Am. Med. Assoc. 259:2103-2107. 

3-202.12 Additives.

1. Barlett, P.A., J.G. Morrie, Jr., and J. Spengler, 1982. Foodborne illness 

associated with niacin: Report of an outbreak linked to excessive niacin in 

enriched cornmeal. Public Health Rep. 97:258-260. 

2. Code of Federal Regulations, Title 9, Subpart C, Section 424.21(b) Food 

ingredients and sources of radiation.

3. Code of Federal Regulations, Title 21, Parts 170-180 relating to food additives 

and irradiation.
FDA Food Code 2022 Annex 2. References

Annex 2 - 28

4. Code of Federal Regulations, Title 21, Parts 181-186 relating to prior-sanctioned 

ingredients and direct and indirect substances generally recognized as safe.

5. Code of Federal Regulations, Title 40, Part 180 Tolerances for pesticides 

chemicals in food, and exceptions. 

6. Food and Drug Administration, 1987. Food Supplies - Sulfiting agents on food in 

retail food establishments (9/10/87). Retail Food Protection Program Information 

Manual. 

7. Food and Drug Administration, 2003. Color Additives: FDA’s Regulatory Process 

and Historical Perspectives. Reprinted from Food Safety Magazine

October/November 2003 issue, CFSAN/Office of Cosmetics and Colors. 

http://www.fda.gov/ForIndustry/ColorAdditives/RegulatoryProcessHistoricalPersp

ectives/default.htm

8. Food and Drug Administration, 2007. Summary of Color Additives Listed for Use 

in the United States in Foods, Drugs, Cosmetics, and Medical Devices. 

CFSAN/Office of Food Additive Safety. 

http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm1156

41.htm

9. Food and Drug Administration, 2009. Inventory of Effective Food Contact 

Substance (FCS) Notifications. CFSAN/Office of Food Additive Safety. Found at 

http://www.accessdata.fda.gov/scripts/fcn/fcnNavigation.cfm?rpt=fcsListing

3-202.13 Eggs.

1. Bradshaw, J.G., D.B. Shah, E. Forney, and J.M. Madden, 1990. Growth of 

Salmonella enteritidis in yolk of shell eggs from normal and seropositive hens. 

J. Food Prot. 53 (12):1033-1036.

2. Centers for Disease Control, 1988. Update: Salmonella enteritidis infections 

and Grade A shell eggs - United States. Morb. Mortal. Wkly. Rep. 37:490-496.

3. Gast, R.K. and C.W. Beard, 1990. Production of Salmonella enteritidis -

contaminated eggs by experimentally infected hens. Avian Dis. 34:438-446.

4. Kim, C.J., D.A. Emery, H. Rinkle, K.V. Nagaraja, and D.A. Halvorson. 1989. 

Effect of time and temperature on growth of Salmonella enteritidis in 

experimentally inoculated eggs. Avian Dis. 33:735-742. 

5. St. Louis, M.E., D.L. Morse, E. Potter, T.M. DeMelfi, J.J. Guzewich, R.V. Tauxe, 

and P.A. Blake. 1988. The emergence of Grade A eggs as a major source of

Salmonella enteritidis infections. J. Am. Med. Assoc. 259:2103-2107. 

6. United States Standards, Grades, and Weight Classes for Shell Eggs, AMS 

56.200 et seq., administered by the Agricultural Marketing Services of USDA. 
FDA Food Code 2022 Annex 2. References

Annex 2 - 29

3-202.14 Eggs and Milk Products, Pasteurized.

1. Baker, R.C., S. Hogarty, W. Poon et al., 1983. Survival of Salmonella

typhimurium and Staphylococcus aureus in eggs cooked by different 

methods. Poultry Sci. 62:1211-1216.

2. Code of Federal Regulations, Title 21, Part 133, Cheeses and related cheese 

products.

3. Code of Federal Regulations, Title 21, Part 135, Frozen desserts. 

4. Code of Federal Regulations, Title 9, Part 590, Inspection of Eggs and Egg 

Products (Egg Products Inspection Act). 

5. Cunningham, F.E., 1977. Egg pasteurization, in Egg Science and Technology, 

2nd Ed., J. Stadelman, and O.J. Cotterill (Eds.), AVI Publishing Company, Inc., 

Westport, CT. pp. 161-186. 

6. Doyle, M.P., L.M. Meske and E.H. Marth, 1985. Survival of Listeria 

monocytogenes during the manufacture and storage of nonfat dry milk. J. Food 

Prot. 48(9):740. 

7. Food and Drug Administration/U.S. Public Health Service Publication No. 229, 

2007 revision. Grade “A” Pasteurized Milk Ordinance. 

http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInf

ormation/Milk/ucm2007968.htm

8. Tacket, C.O., L.B. Dominguez, H.J. Fisher and M.L. Cohen, 1985. An outbreak of 

multiple-drug-resistant Salmonella Enteritis from raw milk. J. Am. Med. Assoc. 

253:2058-2060. 

3-202.16 Ice.

1. Cliver, D.O., 1988. Virus transmission via foods; A scientific status summary by 

the Institute of Food Technologists' Expert Panel on Food Safety and Nutrition. 

Food Technol. 42(10):241-248. 

2. Jackson, G.L., 1990. Parasitic protozoa and worms relevant to the U.S. Food 

Technol. 44(5):106-112. 

3-202.17 Shucked Shellfish, Packaging and Identification.

1. Code of Federal Regulations, Title 21, Subpart D – Specific Administrative 

Decisions Regarding Interstate Shipments, Section 1124.60(d) Molluscan 

shellfish. 

2. Food and Drug Administration/U.S. Public Health Service, 2007. National 

Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish, found 
FDA Food Code 2022 Annex 2. References

Annex 2 - 30

at 

http://www.fda.gov/Food/GuidanceRegulation/FederalStateFoodPrograms/ucm2

006754.htm

3-202.18 Shellstock Identification.

3-202.19 Shellstock, Condition.

1. Code of Federal Regulations, Title 21, Part 1240, Control of Communicable 

Disease, Molluscan Shellfish. 

2. Food and Drug Administration/U.S. Public Health Service, 2007. National 

Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish, found 

at 

http://www.fda.gov/Food/GuidanceRegulation/FederalStateFoodPrograms/ucm2

006754.htm

3. Freudenthal, A.R. and J.L. Jijina. 1988. Potential hazards of Dinophysis to 

consumers and shellfisheries. J. Shellfish Res. 7:695-701. 

4. Klontz, K.C., S. Lieb, M. Schreider, H.T. Janowski, L.M. Baldy and R.A. Gunn. 

1988. Syndromes of Vibrio vulnificus infections: clinical and epidemiological 

features in Florida cases 1981-1987. Ann. Intern. Med. 109:318-323. 

5. Morse, D.L., J.J. Guzewich, J.P. Hanrahan, R. Stricot, M. Shayegani, R. Deible, 

J.C. Grabau, N.A. Nowak, J.E. Herrman, G. Cukor and N.R. Blacklow. 1986. 

Widespread outbreaks of clam and oyster associated gastroenteritis: Role of 

Norwalk virus. N. Engl. J. Med. 314:678-681. 

6. Nishitani, L. and K. Chew. 1988. PSP toxins in Pacific Coast states: monitoring 

programs and effects on bivalve industries. J. Shellfish Res. 1:653-669. 

7. Rippey, S.R., 1994. Seafood Borne Disease Outbreaks. U.S. Department of 

Health & Human Services, Public Health Service, Food and Drug Administration, 

Office of Seafood, 82 pp. 

3-202.110 Juice Treated.

1. Code of Federal Regulations, Title 21, Part 120 Hazard Analysis and Critical 

Control (HACCP) Systems. 

2. Code of Federal Regulations, Title 21, Part 101.17(g) Juices that have not been 

specifically processed to prevent, reduce, or eliminate the presence of 

pathogens.

3. Code of Federal Regulations, Title 21, Part 120.4 Process Controls. 
FDA Food Code 2022 Annex 2. References

Annex 2 - 31

3-203.11 Molluscan Shellfish, Original Container.

1. Food and Drug Administration, 1983. Food Supplies - Special requirements for 

retaining shell-stock "tags". (3/29/83), Retail Food Protection Program 

Information Manual. 

2. Food and Drug Administration, Center for Food Safety and Applied Nutrition, 

2019. National Shellfish Sanitation Program Guide for the Control of Molluscan 

Shellfish, found at https://www.fda.gov/media/143238/download

3-203.12 Molluscan Shellfish, Maintaining Identification.

1. Colburn, K.G., C.A. Kaysner, M.M. Wekell, J.R. Matches, C. Abeyta, Jr. and R.F. 

Stott, 1989. Microbiological quality of oysters (Crassostrea gigas) and water of 

live holding tanks in Seattle, WA markets. J. Food Prot. 52(2):100-104. 

2. Food and Drug Administration/U.S. Public Health Service, 2019. National 

Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish, found 

at https://www.fda.gov/media/143238/download

3-204.10 Food Donation

1. Bill Emerson Good Samaritan Food Donation Action of 1996. 

https://www.govinfo.gov/content/pkg/PLAW-104publ210/pdf/PLAW104publ210.pdf

2. Conference for Food Protection. Comprehensive Guidance for Food Recovery 

Programs. http://www.foodprotect.org/guides-documents/comprehensiveguidance-for-food-recovery-programs/

3. United States Department of Agriculture FSIS Guideline to Assist with the 

Donation of Eligible Meat & Poultry Products to Non-Profit Organizations 

December 2020. https://www.fsis.usda.gov/sites/default/files/media_file/2021-

01/FSIS-Guideline-Food-Donation.pdf

3-301.11 Preventing Contamination from Hands. 

1. Baert L, Uyttendaele M, Van Coillie E, Debevere J., 2008. The reduction of 

murine norovirus 1, B. fragilis HSP40 infecting phage B40-8 and E. coli after a 

mild thermal pasteurization process of raspberry puree. Food Microbiol. 25:871--

4.

2. Bidawid, S., Farber, J.M., and Sattar, S.A. 2000. Contamination of Foods by 

Food Handlers: Experiments on Hepatitis A Virus Transfer to Food and Its 

Interruption. Applied Env. Micro. 66(7): 2759-2763. 

3. Black, R.E., A.C. Dykes, K.E. Anderson et al., 1981. Hand washing to prevent 

diarrhea in day care centers. Am. J. Epidemiol. 113:445-451. 
FDA Food Code 2022 Annex 2. References

Annex 2 - 32

4. Butot S, Putallaz T, Amoroso R, Sanchez G., 2009. Inactivation of enteric viruses 

in minimally processed berries and herbs. Appl. Environ. Microbiol. 75:4155--61.

5. Cannon, J.L., Papafragkou, E., Park, G.W., Osborne, J., Jaykus, L.A., Vinje, J., 

2006. Surrogates for the study of norovirus stability and inactivation in the 

environment: A comparison of murine norovirus and feline calicivirus. J. Food 

Prot. Nov;69(11):2761-5.

6. Centers for Disease Control and Prevention (CDC), 2011. Updated Norovirus 

Outbreak Management and Disease Prevention Guidelines. Morb. Mortal. Wkly. 

Rep. Recommendations and Reports. 60 (3); 1-15.

7. Cliver, D. O., and Kostenbader, K. D., 1984. Disinfection of virus on hands for 

prevention of food-borne disease. Intern. J. Food Microbiol., Vol. 1, pp.75-87.

8. Crisley, F.D. and M.J. Foter. 1965. The use of antimicrobial soaps and 

detergents for hand washing in food service establishments. J. Milk Food 

Technol. 28:278-284. 

9. Croci, L., De Medici, D., Di Pasquale, S. and Toti, L., 2005. Resistance of 

hepatitis A virus in mussels subjected to different domestic cookings, Int. J. Food 

Microbiol. 105 (2), pp. 139–144.

10.Food and Drug Administration, Center for Food Safety and Applied Nutrition, 

2009. Hepatitis A virus, in Bad Bug Book, Foodborne Pathogenic 

Microorganisms and Natural Toxins Handbook, found at 

http://www.fda.gov/Food/FoodborneIllnessContaminants/CausesOfIllnessBadBu

gBook/default.htm

11.Goldmann, D.A., 1991. The role of barrier precautions in infection control. J. 

Hosp. Infect., Vol. 18, (Supplement A), pp. 515-523. 

12.Goldmann, D.A., and Larson, E. 1992. Handwashing and nosocomial infections. 

New Eng. J. Med., Vol. 327, No.2. pp. 120-122. 

13.Hewitt J, Rivera-Aban M, Greening GE. Evaluation of murine norovirus as a 

surrogate for human norovirus and hepatitis A virus in heat inactivation studies. 

2009., J. Appl. Microbiol.; 107:65--71.

14.Horwood, M.P. and V.A. Minch, 1951. The numbers and types of bacteria found 

on the hands of food handlers. Food Res. 16:133-136. 

15.Humphrey, T.J., K.W. Martin, and A. Whitehead. 1994. Contamination of hands 

and work surfaces with Salmonella enteritidis PT4 during the preparation of 

egg dishes. Epidemiol. Infect. 113: 403-409. 

16.Kaferstein, F.K., Motarjemi, Y., and Bettcher, D.W. 1997. Foodborne disease 

control: A transnational challenge, Emerg. Infect. Dis., Vol. 3, No. 4, pp. 503-511. 
FDA Food Code 2022 Annex 2. References

Annex 2 - 33

17.Kennedy, J., Blair, I., McDowell, D. and Bolton, D., 2005. An investigation of the 

thermal inactivation of Staphylococcus aureus and the potential for increased 

thermotolerance as a result of chilled storage. J. Appl. Microbiol., 99: 1229–1235.

18.Laird DT, Sun Y, Reineke KF, Carol Shieh Y., 2011. Effective hepatitis A virus 

inactivation during low-heat dehydration of contaminated green onions. Food 

Microbiol. Aug;28(5): 998-1002. 

19.Lingaas, E. and Fagernes, M., 2009. Development of a method to measure 

bacterial transfer from hands. J. Hosp. Infect. May;72(1):43-49.

20.Lowbury, E.J.L., H.A. Lilly and J.P. Bull, 1964. Disinfection of hands: Removal of 

transient organisms. Brit. Med. J. 2:230-233.

21.Mead, P.S., Slutsker, L., Dietz, V., McCraig, L.F., Bresee, J.S., Shapiro, C., 

Griffin, P.M., Tauxe, R.V., 1999. Food-related illness and death in the United 

States. Emerg. Infect. Dis. Vol. 5, No.5, pp.38, found at 

http://www.cdc.gov/ncidod/EID/vol5no5/mead.htm. 

22.Mokhtari, A. and Jaykus, L.A., 2009. Quantitative exposure model for the 

transmission of norovirus in retail food preparation. Int. J. Food Microbiol. Jul 31; 

133(1-2): 38-47.

23.Mormann, S., M. Dabish and B. Becker. 2010. Effects of technological processes 

on the tenacity and inactivation of norovirus genogroup II in experimentally 

contaminated foods. Appl. Env. Microbiol. 76: 536-545.

24.Murphy, P., Nowak, T., Lemon, S. M. and Hilfenhaus, J. 1993. Inactivation of 

hepatitis a virus by heat treatment in aqueous solution. J. Med. Virol., 41: 61–64.

25.Nuanualsuwan, S. and Cliver, D.O., 2003. Capsid Functions of Inactivated 

Human Picornaviruses and Feline Calicivirus. Appl. Env. Microbiol. 69: 350-357.

26.Parry, J. V. and Mortimer, P. P.,1984. The heat sensitivity of hepatitis A virus 

determined by a simple tissue culture method. J. Med. Virol., 14: 277–283. 

27.Paulson, D.S., 1992. Evaluation of three handwashing modalities commonly 

employed in the food processing industry. Dairy Food Environ. Sanit. 12(10):615-

618.

28.Pether, J.V.S. and R.J. Gilbert, 1971. The survival of salmonellas on finger-tips 

and transfer of the organisms to foods. J. Hyg. Camb. 69:673-681.

29.Rose, J.B., and Slifko, T.R., 1999. Giardia, Cryptosporidium, and Cyclospora and 

their impact on foods: a review. J. Food Protect. Vol. 62., No. 9, pp. 1059-1070. 

30.Ross, M., and Guzewich, J., September 1999. Evaluation of risks related to 

microbiological contamination of ready-to-eat food by food preparation workers 
FDA Food Code 2022 Annex 2. References

Annex 2 - 34

and the effectiveness of interventions to minimize those risks. FDA White Paper, 

FDA, CFSAN. 

31.Smith, J.L., 1993. Cryptosporidium and Giardia as agents of foodborne disease. 

J. Food Protection. Vol. 56: 451-461.

32.Spinks, A.T., Dunstan, R.H., Harrison, T., Coombes, P, Kuczera, G., 2006. 

Thermal inactivation of water-borne pathogenic and indicator bacteria at subboiling temperatures. Water Research 40:1326–1332.

33.Strohbehn, C., Sneed, J., Paez, P., Meyer, J., 2008. Hand washing frequencies 

and procedures used in retail food services. J. Food Prot. Aug;71(8):1641-1650.

34.Teunis, P. F., Moe, C. L., Liu, P., E. Miller, S., Lindesmith, L., Baric, R. S., Le 

Pendu, J. and Calderon, R. L., 2008. Norwalk Virus: How Infectious is It?. J. 

Med. Virol., 80: 1468–1476.

35.Topping JR, Schnerr H, Haines J, et al., 2009. Temperature inactivation of Feline 

calicivirus vaccine strain FCV F-9 in comparison with human noroviruses using 

an RNA exposure assay and reverse transcribed quantitative real-time 

polymerase chain reaction-A novel method for predicting virus infectivity. J. Virol. 

Methods;156:89--95.

36.Williams, R.E.O., 1963. Healthy carriage of Staphylococcus aureus: Its 

prevalence and importance. Bacteriol. Rev. 27:56-71. 

3-302.11 Packaged and Unpackaged Food - Separation, Packaging, and 

Segregation.

1. Code of Federal Regulations, Title 21, Part 109, Unavoidable Contaminants in 

Food for Human Consumption and Food-Packaging Material.

2. Dickson, J.S., 1990. Survival and growth of Listeria monocytogenes on beef 

tissue surfaces as affected by simulated processing conditions. J. Food Safety 

10:165-174.

3. Doyle, M.P. and J.L. Schoeni, 1987. Isolation of Escherichia coli O157:H7 from 

retail fresh meats and poultry. Appl. Environ. Microbiol. 53:2394-2396.

4. Stern, N.J., M.P. Hernandez, L. Blankenship, K.E. Deibel, S. Doors, M.P. Doyle, 

H. Ng, M.D. Pierson, J.N. Sofos, H. Sveum and D.C. Westhoff, 1985. Prevalence 

and distribution of Campylobacter jejuni and Campylobacter coli in retail 

meats. J. Food Prot. 48(7):595-599. 
FDA Food Code 2022 Annex 2. References

Annex 2 - 35

3-302.12 Food Storage Containers, Identified with Common Name of Food.

3-302.13 Pasteurized Eggs, Substitute for Raw Shell Eggs for Certain Recipes.

1. Cunningham, F.E., 1977. Egg pasteurization, in Egg Science and Technology, 

2nd Ed., J. Stadelman, and O.J. Cotterill (Eds.), AVI Publishing Company, Inc., 

Westport, CT. pp 161-186.

2. USDA/ARS. 1969. Egg Pasteurization Manual (ARS 74-48), USDA/ARS Albany, 

CA 94710. 47 pp. 

3-302.15 Washing Fruits and Vegetables.

1. Beuchat, L. 1998. Food Safety Issues. Surface Decontamination of Fruits and 

Vegetables Eaten Raw: A Review. World Health Organization. 42 pp.

2. Chia-Min, Lin, Cheng-I Wei*, 1997. Transfer of Salmonella montevideo onto the 

Interior Surfaces of Tomatoes by Cutting. J. Food Prot. 60(7): 858-863.

3. Geldreich, E.E. and R.H. Bordner, 1971. Fecal contamination of fruits and 

vegetables during cultivation and processing for market. J. Milk Food Technol. 

34:184-195.

4. Heisick, J.E., D.E. Wagner, M.L. Nierman and J.T. Peeler, 1989. Listeria spp. 

found in fresh market produce. Appl. Environ. Microbiol. 55(8):1925-1927.

5. Madden, J.M., 1992. Microbial pathogens in fresh produce - the regulatory 

perspective. J. Food Prot. 55(10):821-823. 

6. Satchell, F.B., P. Stevenson, W.H. Andrews, L. Estela and G. Allen, 1990. The 

survival of Shigella sonnei in shredded cabbage. J. Food Prot. 53:558-562.

7. Steinbrugge, E.S., R.B. Maxcy and M.B. Liewen, 1988. Fate of Listeria 

monocytogenes on ready-to-serve lettuce. J. Food Prot. 51:596-599. 

3-303.11 Ice Used as Exterior Coolant, Prohibited as Ingredient.

3-303.12 Storage or Display of Food in Contact with Water or Ice.

1. Andrews, W.H., C.R. Wilson, P.L. Poelma and A. Romero, 1977. Bacteriological 

survey of channel catfish Ictalurus punctatus at the retail level. J. Food Sci. 

42:359-364. 

3-304.11 Food Contact with Equipment and Utensils. 

1. Chia-Min, Lin, Cheng-I Wei*, 1997. Transfer of Salmonella montevideo onto the 

Interior Surfaces of Tomatoes by Cutting, J. Food Prot. 60(7): 858-863.
FDA Food Code 2022 Annex 2. References

Annex 2 - 36

2. Escartin, E.F., A.C. Ayala and J.S. Lozano, 1989. Survival and growth of 

Salmonella and Shigella on sliced fresh fruit. J. Food Prot. 52(7):471-472.

3. Golden, G.A., E.J. Rhodehamel and D.A. Kautter, 1993. Growth of Salmonella

spp. in cantaloupe, watermelon, and honeydew melons. J. Food Prot. 56(3):194-

196.

4. Humphrey, T.J., K.W. Martin, and A. Whitehead. 1994. Contamination of hands 

and work surfaces with Salmonella enteritidis PT4 during the preparation of 

egg dishes. Epidemiol. Infect. 113: 403-409.

5. Kim, H.U. and J.M. Goepfert, 1971. Occurrence of Bacillus cereus in selected 

dry food products. J. Milk Food Technol. 34:12-15.

6. Lopes, J.A., 1986. Evaluation of dairy and food plant sanitizers against

Salmonella typhimurium and Listeria monocytogenes. J. Dairy Sci. 69:2791-

2796.

7. Reida, P., M. Wolff, H.W. Pohls, W. Kuhlmann, A. Legnacher, S. Aleksic, H. 

Karch, J. Bockemuh. 1994. An Outbreak Due to Enterohemorrhagic Escherichia 

coli O157/H7 in a Children Day-Care-Center Characterized by Person-to-Person 

Transmission and Environmental Contamination. Zentralblatt Fur BakteriologieInternational, Int. J. Med. Micro. Vir. Para. Infect. Dis. 28(4): 534-543. 

8. Scott, Elizabeth and Sally F. Bloomfield. 1990. The Survival and Transfer of 

Microbial Contamination via Cloths, Hands, and Utensils. J. Appl. Bacteriol. 68: 

271-278. 

3-304.12 In-Use Utensils, Between-Use Storage.

1. Food and Drug Administration, 1984. Food Preparation - Between-use storage of 

food preparation utensils (5/14/84). Retail Food Protection Program Information 

Manual. 

3-304.14 Wiping Cloths, Limitation. 

1. Scott, Elizabeth and Sally F. Bloomfield. 1990. Investigations of the effectiveness 

of detergent washing, drying and chemical disinfection on contamination of 

cleaning cloths. J. Appl. Bacteriol. 68: 279-283.

2. Scott, Elizabeth and Sally F. Bloomfield. 1990. The Survival and Transfer of 

Microbial Contamination via Cloths, Hands and Utensils. J. Appl. Bacteriol. 68: 

271-278. 
FDA Food Code 2022 Annex 2. References

Annex 2 - 37

3-304.15 Gloves, Use Limitation. 

1. Beezhold, Donald H., David A. Kostyal, and Jeffrey Wiseman. March 1994. The 

Transfer of Protein Allergens From Latex Gloves. AORN J. 59(3): 605-613.

2. Reddy, Sumana, M.D. January 1, 1998. Latex Allergy. Am. Fam. Phys. 57(1): 93-

100.

3. Schwartz, Howard J., 1995, Latex: A potential hidden “food” allergen in fast food 

restaurants, J. Allergy Clin. Immunol. 95: 139-140.

4. Tomazic, Vesna J., Eric L. Shampaine, Anthony Lamanna, Thomas J. Withrow, 

Franklin N. Adkinson, Jr., and Robert G. Hamilton. April, 1994. Cornstarch 

Powder on Latex Products is an Allergen Carrier, J. Allergy Clin. Immunol. 93(4): 

751-758. 

3-304.17 Refilling Returnables.

1. Food and Drug Administration, 1985. Food Protection - Refilling of take-home 

beverage containers (8/29/85). Retail Food Protection Program Information 

Manual. 

3-306.13 Consumer Self-Service Operations.

1. Food and Drug Administration, 1984. Food Protection - Customer self-service of 

bulk food (4/16/84). Retail Food Protection Program Information Manual. 

3-401.11 Raw Animal Foods.

1. Baker, R.C., 1990. Survival of Salmonella enteritidis on and in shelled eggs, 

liquid eggs, and cooked egg products. Dairy Food Environ. Sanit. 10(5):273-275. 

2. Blankenship, L.E. and S.E. Craven, 1982. Campylobacter jejuni survival in 

chicken meat as a function of temperature. Appl. Environ. Microbiol. 44(1):88-92.

3. Bryan, F.L. and T.W. McKinley, 1979. Hazard analysis and control of roast beef 

preparation in foodservice establishments. J. Fod Prot. 42(1):4-18.

4. Buzby, Jean C. “Children and Microbial Foodborne Illness,” Food Review Volume 

24, Issue 2, pages 32-37. May-August, 2001

5. Castellani, A.G., R.R. Clark, M.I. Gibson and D. F. Meisner, 1952. Roasting time 

and temperature required to kill food poisoning microorganisms introduced 

experimentally into stuffing in turkeys, Food Res. 18:131-138.

6. Centers for Disease Control, 1993. Update: Multistate outbreak of Escherichia 

coli O157:H7 infections from hamburgers - western United States, 1992, 1993. 

Morb. Mortal. Wkly. Rep. 42 (14):258-263. 
FDA Food Code 2022 Annex 2. References

Annex 2 - 38

7. Code of Federal Regulations, Title 9, Part 318.10, Prescribed Treatment of Pork 

and Products Containing Pork to Destroy Trichinae. 

8. Doyle, M.P. and J.L. Schoeni, 1984. Survival and growth characteristics of 

Escherichia coli associated with hemorrhagic colitis. Appl. Environ. Microbiol. 

48 (4):855-856. 

9. “Draft Risk Assessment of the Public Health Impact of Escherichia coli O157:H7 

in Ground Beef, Executive Summary,” Office of Public Health and Science/Food 

Safety and Inspection Service/USDA, October, 2001. 

https://www.fsis.usda.gov/node/2003

10.Dubey, J.P., A.W. Kotula, A. Sharar, C.D. Andrews, and D.S. Lindsay, 1990. 

Effect of high temperature on infectivity of Toxoplasma gondii tissue cysts in 

pork. J. Parasitol., 76 (2):201-204. 

11.Dubey, J.P., 1998. Toxoplasma gondii Oocyst Survival under Defined 

Temperatures. J. Parasitol. 84(4):862-865.

12.FoodNet Foodborne Diseases Active Surveillance Network, 1998 Final Report. 

March 2000. Found at http://www.cdc.gov/foodnet/data/reports.html

13.Goodfellow, S.J. and W.L. Brown, 1978. Fate of Salmonella inoculated into beef 

for cooking. J. Food Prot. 41(8):598-605. 

14.Hague, M.A., K.E. Warren, M.C. Hunt, D.H. Kropf, C.L. Kastner, S.L. Stroda, and 

D.E. Johnson, 1994. Endpoint Temperature, Internal Cooked Color, and 

Expressible Juice Color Relationships in Ground Beef Patties, J. Food Sci. 

59(3):465-470.

15.Jay, Michele T., Garrett, V., et. al, “A Multi-state Outbreak of Escherichia coli

O157:H7 Infection Linked to Consumption of Beef Tacos at a Fast-Food 

Restaurant Chain”, Clinical Infectious Diseases. 2004:39(1):1-7.

16.Kotula, A.W., K.D. Murell, L. Acosta-Stein and L. Lamb, 1983. Trichinella 

spiralis: Effect of high temperature on infectivity in pork. Exp. Parasitol. 56:15-

19. 

17.Line, J.E., A.R. Fain, Jr., A.B. Moran, L.M. Martin, R.V. Lechowich, J.M. 

Carosella and W.L. Brown, 1991. Lethality of heat to Escherichia coli O157:H7: 

D-value and Z-value determinations in ground beef. J. Food Prot. 54 (10):62-766.

18.Shah, D.B., J.G. Bradshaw and J.T. Peeler. 1991. Thermal resistance of eggassociated epidemic strains of Salmonella enteritidis. J. Food Sci. 56:391-393.

19.Smith, J.L., 1994. Taenia solium neurocysticercosis. J. Food Prot. 57(9): 831-

844.
FDA Food Code 2022 Annex 2. References

Annex 2 - 39

20.Smith, J.L., 1992. Toxoplasma gondii in meats - a matter of concern? Dairy 

Food Environ. Sanit. 12(6):341-345.

21.Ward, D.R. and C.R. Hackney, 1991. Microbiology of Marine Food Products. Van 

Nostrand Reinhold, New York. 212 pp.

22.Webster, R.C. and W.B. Esselen, 1956. Thermal resistance of food poisoning 

microorganisms in poultry stuffing. J. Milk Food Technol. 19:209-212.

3-401.12 Microwave Cooking.

1. Aleixa, J.A.G., B. Swaminathan, K.S. Jamesen and D.E. Pratt, 1985. Destruction 

of pathogenic bacteria in turkeys roasted in microwave ovens. J. Food Sci. 

50:873-875, 880.

2. Czechowicz, S.M. 1996. Destruction of Escherichia coli O157:H7 in food and 

Non-Food Systems by Microwaves. Ph.D. Thesis. University of Minnesota. 241 

pages.

3. Craven, S.E. and H.S. Lillard, 1974. Effect of microwave heating of precooked 

chicken on Clostridium perfringens. J. Food Sci. 39:211-212.

4. Dahl, C.A., M.E. Matthews and E.H. Marth, 1980. Fate of Staphylococcus 

aureus in beef loaf, potatoes and frozen and canned green beans after 

microwave heating in a simulated cook/chill hospital food service system. J. Food 

Prot. 43:916-923.

5. Heddleson, R.A. and S. Doores, 1993. Factors Affecting Microwave Heating of 

Foods and Microwave Induced Destruction of Food Pathogens - A Review. J. 

Food Prot. 57(11)1025-1037.

6. Heddleson, R.A., S. Doores, R.C. Anantheswaran, and G.D. Kuhn, 1993. 

Viability Loss of Salmonella Species, Staphylococcus aureus, and Listeria 

monocytogenes in Complex Foods Heated by Microwave Energy. J. Food Prot. 

59(8)813-818.

7. Sawyer, C.A., S.A. Biglari, and S.S. Thompson, 1984. Internal end temperature 

and survival of bacteria on meats with and without a polyvinylidene chloride wrap 

during microwave cooking. J. Food Sci. 49(3):972-973.

8. Sawyer, C.A., 1985. Post-processing temperature rise in foods: Hot air and 

microwave ovens. J. Food Prot. 48(5):429-434.

3-401.14 Non-Continuous Cooking of Raw Animal Foods. 

1. Appendix B, Compliance Guidelines for Cooling Heat-Treated Meat and Poultry 

Products (Stabilization) found at https://www.fsis.usda.gov/guidelines/2021-0013
FDA Food Code 2022 Annex 2. References

Annex 2 - 40

2. Code of Federal Regulations, Title 9, § 318.23 Heat-processing and stabilization 

requirements for uncured meat patties found at 

http://edocket.access.gpo.gov/cfr_2011/janqtr/pdf/9cfr318.23.pdf

3. Code of Federal Regulations, Title 9, § 381.150 Requirements for the production 

of fully cooked poultry products and partially cooked poultry breakfast strips 

found at http://edocket.access.gpo.gov/cfr_2011/janqtr/pdf/9cfr381.150.pdf

3-402.11 Parasite Destruction.

1. Bier, J.W. 1976. Experimental Anisakiasis: Cultivation and Temperature 

Tolerance Determinations. J. Milk Food Technol. 39:132-137.

2. Deardorff, T.L., R.B. Raybourne, R.S. Desowitz, 1986. Behavior and viability of 

third stage larvae of Terranova (HA) and Anisakis simplex (Type 1) under 

coolant conditions. J. Food Prot. 47:49-52.

3. Deardorff, T.L. and R. Throm, 1988. Commercial blast-freezing kills third stage 

larvae of Anisakis simplex encapsulated in salmon and rockfish. J. Parasitol. 

74:233-250.

4. Food and Drug Administration, 1987. Food Preparation - Raw, marinated or 

partially cooked fishery products. Retail Food Protection Program Information 

Manual (8/21/87).

5. Food and Drug Administration, 1998. Fish and Fishery Products Hazards and 

Controls Guide, Office of Seafood. 276 pp.

6. Food and Drug Administration, 2011. Fish and Fishery Products Hazards and 

Controls Guidance, 4th Edition, April 2011.

7. Gustafson, P.V. 1953. The effect of freezing on encysted Anisakis larvae. J. 

Parasitol. 39:585-588.

8. Haigashi, G.I., 1985. Foodborne parasites transmitted to man from fish and other 

aquatic foods. Food Technol. 39(3):69-74.

9. Jackson, G.L., 1990. Parasitic protozoa and worms relevant to the U.S. Food 

Technol. 44(5):106-112. 

10.Kaneko, J., and P. Bartram, 1994. A position paper dated May 25, 1994 

submitted to Dockets Management Branch, U.S. Food and Drug Administration 

in response to the proposed FDA HACCP program for seafood. See Part 4: 

Critical Review of FDA Position on Parasite Hazards in Tuna. 

11.Ronald, K., 1960. The effects of physical stimuli on larval stages of Terranova 

decipiens. Can. J. Zool. 38:623-642.
FDA Food Code 2022 Annex 2. References

Annex 2 - 41

12.Ruitenberg, E.J., 1970. Anisakiasis: Pathogenesis, Serodiagnosis and Control. 

University of Utrecht, Netherlands. 138 pp. 

3-402.12 Records, Creation, and Retention.

3-403.11 Reheating for Hot Holding.

1. Bennett, R.W. and M.R. Berry, 1987. Serological activity and in vitro toxicity of 

Staphylococcus aureus enterotoxins A and D in selected canned foods. J. 

Food Sci. 52:416-418. 

2. Bradshaw, J.G., J.T. Peeler and R.M. Twedt, 1979. Thermal inactivation of 

Clostridium botulinum toxins types A and B in buffer, and beef and mushroom 

patties. J. Food Sci. 44(6):1653-1657. 

3. Craven, S.E., 1980. Growth and sporulation of Clostridium perfringens in 

foods. Food Technol. 34(4):80-87.

4. Food Refrigeration & Process Engineering Research Centre, reporting period 1 

March 95 to 1 August 96. Determination of unsatisfactory temperature 

distributions within foods heated in microwave ovens. Measurement and Testing 

Programme (MTP), Framework 3, Part 2, contract number MATI-CT 940014, 

University of Bristol, UK.

5. Heddleson, R.A., S. Doores, R.C. Anantheswaran, and G.D. Kuhn, 1993. 

Viability Loss of Salmonella Species, Staphylococcus aureus, and Listeria 

monocytogenes in Complex Foods Heated by Microwave Energy. J. Food Prot. 

59(8)813-818.

6. Johnson, K.M., C.L. Nelson and F.F. Busta, 1983. Influence of temperature on 

germination and growth of spores of emetic and diarrheal strains of Bacillus 

cereus in growth medium and in rice. J. Food Sci. 48:286-287.

7. Licciardello, J.J., C.A. Ribich, J.T.R. Nickerson and S.A. Goldblith, 1967. Kinetics 

of the thermal inactivation of type E Clostridium botulinum toxin. Appl. 

Microbiol. 15(2):344-349.

8. Roy, R.J., F.F. Busta and D.R. Thompson, 1981. Thermal inactivation of 

Clostridium perfringens after growth at several constant and linearly rising 

temperatures. J. Food Sci. 46:1586-1591.

9. Woodburn, M.J., E. Somers, J. Rodriguez and E.J. Schantz, 1979. Heat 

inactivation rates of botulism toxin A, B, E, and F in some foods and buffers. J. 

Food Sci. 44:1658-1661. 
FDA Food Code 2022 Annex 2. References

Annex 2 - 42

3-501.11 Frozen Food.

3-501.12 Time/Temperature Control for Safety Food, Slacking.

3-501.13 Thawing.

1. Bryan, F.L. and T.W. McKinley, 1974. Prevention of foodborne illness by timetemperature control of thawing, cooking, chilling and reheating of turkeys in 

school lunch kitchens. J. Milk Food Technol. 37:420-429. 

3-501.14 Cooling. 

1. Blankenship, L.C., S.E. Craven, R.G. Leffler and C. Custer, 1988. Growth of 

Clostridium perfringens in cooked chili during cooling. Appl. Environ. Microbiol. 

54(5):1104-1108.

2. Bryan, F.L., 1974. Identifying Foodborne Disease Hazards in Food Service 

Establishments. J. Environ. Health 36(6):537-540. 

3. Bryan, F.L., 1979. Prevention of Foodborne Diseases in Food Service 

Establishments. J. Environ. Health 41(4):198-206.

4. Dickerson, R.W., Jr. and R.B. Read, Jr., 1973. Cooling rates of foods. J. Milk 

Food Technol. 36(3):167-171.

5. Juneja, V.K., O.P. Snyder, Jr., and M. Cygnarowicz-Provost. 1994. Influence of 

cooling rate on outgrowth of Clostridium perfringens spores in cooked ground 

beef. J. Food Prot. 57:(12):1063-1067.

6. Lewis, M.N., H.H. Weisner and A.R. Winter, 1953. Bacterial growth in chicken 

salad. J. Am. Diet. Assoc. 29:1094-1099.

7. Longrée, K. and J.C. White, 1955. Cooling rates and bacterial growth in food 

prepared and stored in quantity. I. Broth and white sauce. J. Am. Diet. Assoc. 

31:124-132. 

8. USDA/FSIS. 1999. Final Rule-Performance Standards for the Production of 

Certain Meat and Poultry Products. Federal Register, 64:(3):732-749.* 

3-501.15 Cooling Methods.

1. Bryan, F.L., 1990. Application of HACCP to ready-to-eat chilled foods. Food 

Technol. 45(7):7077. 

2. Rollin, J.L. and M.E. Matthews, 1977. Cook-chill foodservice systems: 

Temperature histories of a cooked beef product during the chilling process. J. 

Food Prot. 40:782-784. 
FDA Food Code 2022 Annex 2. References

Annex 2 - 43

3-501.16 Time/Temperature Control for Safety Food, Hot and Cold Holding.

1. Abdul-Raouf, U.M., L.R. Beauchat and M.S. Ammar, 1993. Survival and growth 

of Escherichia coli:O157:H7 in ground roasted beef as affected by pH, 

acidulants, and temperature. Appl. Environ. Microbiol. 59(8):2364-2368. 

2. Ahmed, A. A., M.K. Moustafa and E.H. Marth. 1983. Incidence of Bacillus 

cereus in milk and some milk products. J. Food Prot. 46:126-128.

3. Angelotti, R., M.J. Foter and K.L. Lewis, 1961. Time-temperature effects on 

Salmonellae and Staphylococci in foods. II. Behavior in warm holding 

temperatures. Am. J. Public Health 51:76-88.

4. Baxter R. and W.H. Holzapfel. 1982. A microbial investigation of selected spices, 

herbs, and additives in South Africa. J. Food Sci. 47: 570-578. 

5. Blankenship, L.C. Craven, S.C., Leffler, R. G. and C. Custer. 1988. Growth of 

Clostridium perfringens in cooked chili during cooling. Appl. Environ. Microbiol. 

54: 1104-1108. 

6. Brown, D.F. and R.M. Twedt, 1972. Assessment of the sanitary effectiveness of 

holding temperatures on beef cooked at low temperature. Appl. Microbiol. 24: 

599-603.

7. Bryan, F.L., C.A. Bartleson, and N. Christopherson. 1981. Hazard analyses, in 

reference to Bacillus cereus, of boiled and fried rice in Cantonese-style 

restaurants. J. Food Prot. 44:500-512. 

8. Collee, J.G., Knolden, J.A. and B.C. Hobbs. 1961. Studies on the growth, 

sporulation and carriage of Clostridium welchii with special reference to food 

poisoning strains. J. Appl. Bacteriol. 24:326-329.

9. Craven, S.E. Blankenship, L.C. and J.L. McDonel. 1981. Relationship of 

sporulation, enterotoxin formation and spoilage during growth of Clostridium 

perfringens type A in cooked chicken. Appl. Environ. Microbiol. 41: 1184-1191.

10.Doyle, M.P., N.J. Bains, J.L. Schoeni and E.M. Foster, 1982. Fate of Salmonella 

typhimurium and Staphylococcus aureus in meat salads prepared with 

mayonnaise. J. Food Prot. 45:152-156.

11.El-Sherbeeny, M.R., M.F. Saddik, H.E-L. Aly, and F.L. Bryan. 1985. 

Microbiological profile and storage temperatures of Egyptian rice dishes. J. Food 

Prot. 48: 39-43.

12.Fermanian, C., Fremy, M. and M. Claisse. 1994. Effect of temperature on the 

vegetative growth of type and field strains of Bacillus cereus. Let. Appl. Microbiol. 

19: 414-418. 
FDA Food Code 2022 Annex 2. References

Annex 2 - 44

13.Hall, H.E. and R. Angelotti. 1965. Clostridium perfringens in meat and meat 

product. Applied Microbiology. 13: 352-354.

14.Johnson, K. M., Nelson, C. L. and F. F. Busta. 1983. Influence of temperature on 

germination and growth of spores of emetic and diarrheal strains of Bacillus 

cereus in a broth model and in rice. J. Food Sci. 48: 286-287. 

15.Kim, H.U. and J.M. Goepfert. 1971. Occurrence of Bacillus cereus in selected 

dry food products. J. Milk Food Technol. 34:12-15. 

16.Ladiges, W.C., J.F. Foster and W.M. Ganz. 1974. Incidence and viability of 

Clostridium perfringens in ground beef. J. Milk Food Technol. 37(12) 622-623. 

17.Lillard, H.S. 1971. Occurrence of Clostridium perfringens in boiler processing 

and further processing operations. J. Food Science. 36: 1008-1010. 

18.Makukutu, C.A. and R.K. Guthrie, 1986. Survival of Escherichia coli in food at 

hot-holding temperatures. J. Food Prot. 49(7):496-499. 

19.Mead, G.C. 1969. Growth and sporulation of Clostridium welchii in breast and 

leg muscle of poultry. J. Appl Bacteriol. 32:86-95.

20.Mead, P., L. Slutsker, V. Dietz, L. F. McCaig, J. S. Bresee, C. Shapiro, P. M. 

Griffin, and R. V. Tauxe. 1999. Food related illness and death in the United 

States. Emerging Infect Dis 5:607-625.

21.Mikolajcik, E. M., Kearney, J.W. and T. Kristofferson. 1973. Fate of Bacillus 

cereus in cultured and direct acidified skim milk and cheddar cheese. J Milk 

Food Technol. 36: 317-320.

22.Morita, T.N. and M.J. Woodburn. 1977. Stimulation of Bacillus cereus growth by 

protein in cooked rice combinations. J. Food Sci. 42 (5) 1232-1235.

23.Nakamura, M. and K.D. Kelly. 1968. Clostridium perfringens in dehydrated 

soups and sauces. J. Food Science 33:424-426. 

24.Park, Y. and E.M. Mikolaicik. 1979. Effect of temperature on growth and alpha 

toxin production by Clostridium perfringens. J Food Protect. 42:848-851. 

25.Rusul, G. and N. H. Yaacob. 1995. Prevalence of Bacillus cereus in selected 

foods and detection of enterotoxin using TECRA-VIA and BCET-RPLA. Int. J. 

Food Microbiol. 25: 131-139.

26.Seals, J.E., J.D. Snyder, T.A. Edell et al., 1981. Restaurant associated botulism: 

transmission by potato salad. Am. J. Epidemiol. 113:436-444. 

27.Shoemaker, S. P., and M. D. Pierson. 1976. “Phoenix phenomenon” in the 

growth of Clostridium perfringens. Appl. Environ. Micro. 32(6): 803-807. 
FDA Food Code 2022 Annex 2. References

Annex 2 - 45

28.Smart, J.L., T.A. Roberts, M.F. Stringer, and N. Shah. 1979. The incidence and 

serotypres of Clostridium perfringens on beef, pork and lamb carcasses. J.

Applied Bacteriology. 46:377-383. 

29.Solomon, H.M. and D.A. Kautter, 1988. Outgrowth and toxin production by 

Clostridium botulinum in bottles of chopped garlic. J. Food Prot. 51(11):862-

865. 

30.Strong, D., J.C. Canada and B. Griffiths. 1962. Incidence of Clostridium 

perfringens in American foods. Appl. Microbiol. 11:42-44. 

31.Strong, D.H. and N.M. Ripp, 1967. Effect of cooking and holding on hams and 

turkey rolls contaminated with Clostridium perfringens. Appl. Microbiol. 

15:1172-1177. 

32.Willardsen, R.R., F.F. Busta, C.E. Allen and L.B. Smith, 1978. Growth and 

survival of Clostridium perfringens during constantly rising temperatures. J. 

Food Sci. 43:470-475. 

33.Willardsen, R.R., Busta, F.F., Allen, C.E. 1979. Growth of Clostridium 

perfringens in three different beef media and fluid thioglycollate medium at static 

and constantly rising temperatures. J. Food Protect. 42: 144-148. 

3-501.17 Ready-to-Eat, Time/Temperature Control for Safety Food, Date Marking.

3-501.18 Ready-to-Eat, Time/Temperature Control for Safety Food, Disposition.

1. Chen, Y., W.H. Ross, V.N. Scott, V.N. and D.E. Gombas, 2003. Listeria

monocytogenes: Low Levels Equal Low Risk. J. Food Prot. 66(4):570-577.

2. Code of Federal Regulations, Title 21, Part 114 Acidified foods. 

3. Code of Federal Regulations, Title 21, Part 133 Cheeses and related cheese 

products. 

4. Code of Federal Regulations, Title 9, Part 430. 2003. Control of Listeria 

monocytogenes in Ready-to-Eat Meat and Poultry Products. 

5. Code of Federal Regulations, Title 21, Part 117 Current good manufacturing 

practice in manufacturing, packing, or holding human food. 

6. Code of Federal Regulations, Title 9, Part 317 Labeling, marking devices, and 

containers. 

7. Code of Federal Regulations, Title 21, Part 131 Milk and cream. 

8. Food and Drug Administration/CDC, 2003. Reducing the Risk of Listeria 

monocytogenes, FDA/CDC 2003 Update of the Listeria Action Plan, found at 
FDA Food Code 2022 Annex 2. References

Annex 2 - 46

http://www.fda.gov/Food/FoodborneIllnessContaminants/FoodborneIllnessesNee

dToKnow/ucm332272.htm

9. Food and Drug Administration/USDA/CDC, 2003. Quantitative Assessment of the 

Relative Risk to Public Health from Foodborne Listeria monocytogenes Among 

Selected Categories of Ready-to-Eat Foods. 

10.Food and Drug Administration Docket No. 99N-1168 and FSIS Docket No. 

00-048N, 2001. Draft Assessment of the Relative Risk to Public Health from 

Foodborne Listeria monocytogenes Among Selected Categories of Ready-toEat Foods.

11.Food and Drug Administration,1999. Date Marking of Cheese. Retail Food 

Protection Team Program Information Manual (12/15/99), found at 

http://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/IndustryandR

egulatoryAssistanceandTrainingResources/ucm113942.htm

12.Genigeorgis, C., M. Carniciu, D. Dutulescu and T.B. Farver, 1991. Growth and 

Survival of Listeria monocytogenes in Market Cheeses Stored at 4 to 30oC. J. 

Food Prot. 54(9):662-668.

13.Gombas, D.E., Y. Chen, R. Clavero, R. and V.N. Scott, V.N, 2003. Survey of 

Listeria monocytogenes in Ready-to-Eat Foods. J. Food Prot. 66(4):559-569. 

14.Palumbo, S.A., 1986. Is refrigeration enough to restrain foodborne pathogens? J. 

Food Prot. 49(12):1003-1009.

15.Rosso, L., S. Bajard, J.P. Flandrois, C. Lahellec, J. Fournaud and P. Veit, 1996. 

Differential Growth of Listeria monocytogenes at 4 and 8oC: Consequences for 

the Shelf Life of Chilled Products, J. Food Prot. 59:944-949. 

16.Ryser, E.T., E.H. Marth, 1987. Behavior of Listeria monocytogenes during the 

Manufacture and Ripening of Cheddar Cheese. J. Food Prot. 50(1):7-13. 

17.Steinbruegge, E.D., R.B. Maxcy and M.B. Liewen, 1988. Fate of Listeria 

monocytogenes on ready to serve lettuce. J. Food Prot. 51:596-599. 

18.USDA Agricultural Research Service. Pathogen Modeling Program Version 7.0. 

Microbial Food Safety Research Unit, Wyndmoor, PA., found at 

http://ars.usda.gov/Main/docs.htm?docid=11566 . 

19.Wallace, F.M., J.E. Call, A.C.S. Porto, G.J. Cocoma, ERRC Special Project 

Team, and J.B. Luchansky, 2003. Recovery Rate of Listeria monocytogenes 

from Commercially Prepared Frankfurters during Extended Refrigerated Storage. 

J. Food Prot. 66(4):584-591.

20.Yousef, A.E. and E.H. Marth, 1988. Behavior of Listeria monocytogenes during 

the Manufacture and Storage of Colby Cheese. J. Food Prot. 51(1):12-15. 
FDA Food Code 2022 Annex 2. References

Annex 2 - 47

3-501.19 Using Time as a Public Health Control. 

1. Bryan, F. L. and E. G. Kilpatrick, 1971. Clostridium perfringens related to roast

beef cooking, storage and contamination in a fast food service restaurant. Am. 

J. of Public Health. 61 (9): 1869-1885.

2. Conference for Food Protection, Council III Committee Report, 2004. Time as a

Public Health Control, Conference for Food Protection.

3. Danyluk, M. D., Friedrich, L. M., & Schaffner, D. W. (2014). Modeling the growth 

of Listeria monocytogenes on cut cantaloupe, honeydew and watermelon. Food 

microbiology, 38, 52-55. 

4. de Modelos, D. (2007). Growth of Salmonella Enteriditidis and Listeria 

Monocytogenes in melon pulp: predictive modelling and evaluation of model 

performance. Braz. J. Food Technol, 10(3), 176-182.

5. Doan, C. H. and P. M. Davidson, 1999. Growth of Bacillus cereus on OilBlanched Potato Strips for “Home-Style” French Fries. J. Food Sci. 64:909-912.

6. Doan, C. H. and P. M. Davidson, 1999. Growth and Production of Enterotoxin A

by Staphylococcus aureus on “Home-Style” French Fries. J. Food Sci. 64:913-

917.

7. Ferguson, R. D. and L.A. Shelef, 1990. Growth of Listeria monocytogenes in

soy milk. Food Micro. 7: 49-52.

8. ICMSF, 1996. Microorganisms in Foods 5. Characteristics of Microbial 

Pathogens. Chapter 2 Bacillus Cereus. P20-35. Blackie Academic &

Professional, London.

9. ICMSF, 1996. Microorganisms in Foods 5. Characteristics of Microbial 

Pathogens. Chapter 6 Clostridium perfringens. P112-125. Blackie Academic &

Professional, London.

10.Johnson, K.M., C.L. Nelson and F.F. Busta, 1983. Influence of temperature on

germination and growth of spores of emetic and diarrheal strains of Bacillus 

cereus in growth medium and in rice. J. Food Sci. 48:286-287.

11.Mead, P.S., L. Slutsker, V. Dietz, L.F. McCaig, J.S. Bresee, C. Shapiro, P. 

Griffen, and R.V. Tauxe, 1999. Food related illness and death in the United

States. Emerging Infectious Disease. 5 (5): 607-625.

12.Melling, J.and B.J. Capel, 1978. Characteristics of Bacillus cereus toxin. FEMS

Micro Letters. 4:133-135.

13.Mishra, A., Guo, M., Buchanan, R. L., Schaffner, D. W., & Pradhan, A. K. (2017). 

Prediction of Escherichia coli O157: H7, Salmonella, and Listeria monocytogenes
FDA Food Code 2022 Annex 2. References

Annex 2 - 48

growth in leafy greens without temperature control. Journal of food 

protection, 80(1), 68-73.

14.Pan, W., & Schaffner, D. W. (2010). Modeling the growth of Salmonella in cut red 

round tomatoes as a function of temperature. Journal of food protection, 73(8), 

1502-1505.

15.Salazar, J. K., Sahu, S. N., Hildebrandt, I. M., Zhang, L., Qi, Y., Liggans, G., ... & 

Tortorello, M. L. (2017). Growth Kinetics of Listeria monocytogenes in Cut 

Produce. Journal of food protection, 80(8), 1328-1336.

16.Sionkowski, P.J. and L.A. Shelef, 1990. Viability of Listeria monocytogenes

strain Brie-1 in the avian egg. J. Food Prot. 53 (1): 15-17.

17.Solomon, H.M. and D.A. Kautter, 1986. Growth and toxin production by 

Clostridium botulinum in sautéed onions. J. Food Prot. 49(10):618-620.

18.Solomon, H.M. and D.A. Kautter, 1988. Outgrowth and toxin production by 

Clostridium botulinum in bottled chopped garlic. J. Food Prot. 51(11):862-865.

19.Tatini, S.R., 1973. Influence of food environments on growth of

Staphylococcus aureus and production of various enterotoxins. J. Milk Food 

Technol. 36(11):559-563.

20.USDA Agriculture Agricultural Research Service. Pathogen Modeling Program

Version 7.0. Microbial Food Safety Research Unit, Wyndmoor, PA., found at 

http://ars.usda.gov/Services/docs.htm?docid=11550

3-502.11 Variance Requirement.

1. Barber, F.E. and R.H. Deibel, 1972. Effect of pH and oxygen tension on 

Staphylococcal growth and enterotoxin formation in fermented sausage. Appl. 

Microbiol. 24:891-898. 

2. Dickerson, R.W. and R.B. Read. 1968. Calculations and measurement of heat 

transfer in foods. Food Technol. 22:1533.

3. Dickerson, R.W. and R.B. Read, 1973. Cooling rates in foods. J. Milk Food 

Technol. 36(3):167-171.

4. Food and Drug Administration, 1999. Guidance for Industry: Reducing Microbial 

Food Safety Hazards for Sprouted Seeds, Washington, D.C., found at 

https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryIn

formation/ProducePlantProducts/ucm2007944.htm

5. Food and Drug Administration, 1999. Guidance for Industry: Sampling and 

Microbial Testing of Spent Irrigation Water During Sprout Production, 

Washington, D.C., found at 
FDA Food Code 2022 Annex 2. References

Annex 2 - 49

https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryIn

formation/ProducePlantProducts/ucm2007944.htm

6. Montville, R. and D.W. Schaffner, 2004. Analysis of Published Sprout Seed

Sanitation Studies Shows Treatments Are Highly Variable. J. Food Prot. 67(4): 

758-765.

7. National Advisory Committee on Microbiological Criteria for Foods, 1992. Hazard 

analysis and critical control point system. Int. J. Food Microbiol. 16:1-23.

8. Pierson, M.D. and D. A. Corlett Jr. (Eds.) 1992. HACCP Principles and 

Applications. Van Nostrand Reinhold, New York. 212 pp.

9. Shigehisa, T., T. Nakagami and S. Taji, 1985. Influence of heating and cooling 

rates on spore germination and growth of Clostridium perfringens in media and 

in roast beef. Jpn. J. Vet. Sci. 47(2):259.

10.Snyder, O.P., Jr., 1986. Applying the Hazard Analysis and Critical Control Points 

system in foodservice and foodborne illness prevention. J. Foodservice Systems 

4:125-131.

11.Sperber, W.H., 1982. Requirements of Clostridium botulinum for growth and 

toxin production. Food Technol. 36(12):89-94.

12.Tanaka, N., 1982. Challenge of pasteurized process cheese spreads with 

Clostridium botulinum using in-process and post-process inoculation, J. Food 

Prot. 45:1044-1050.

13.Troller, J.A., 1972. Effect of water activity on enterotoxin A production and growth 

of Staphylococcus aureus. Appl. Microbiol. 24(3):440-443.

3-502.12 Reduced Oxygen Packaging Without a Variance, Criteria.

1. Association of Food and Drug Officials, 1990. Retail guidelines - Refrigerated 

foods in reduced oxygen packages. J. Assoc. Food Drug Offic. 54(5):80-84.

2. Aureli, P., M. Di Cunto, A. Maffei, G. De Chiara, G. Fransiosa, L. Accorinti, A.M. 

Gambardella, and D. Greco. 2000. An outbreak in Italy of botulism associated 

with a dessert made with mascarpone cream cheese. Europ. J. Epidemiol. 

16:913-918.

3. Bennett, R.W. and W.T. Amos, 1982. Staphylococcus aureus growth and toxin 

production in nitrogen packed sandwiches. J. Food Prot. 45(2):157-161.

4. Berrang, M.E., R.E. Brackett and L.R. Beuchat, 1989. Growth of Listeria 

monocytogenes on fresh vegetables under controlled atmosphere. J. Food Prot. 

52:702-705.
FDA Food Code 2022 Annex 2. References

Annex 2 - 50

5. Briozzo, J., E.A. de Lagarde, J. Chirife, and J.L. Parada. 1983. Clostridium 

botulinum Type A growth and toxin Production in media and process cheese 

spread. Appl. and Env. Microbiol.. 45:1150-1152.

6. Code of Federal Regulations, Title 21, Part 133 Cheeses and Related Cheese 

Products.

7. Code of Federal Regulations, Title 9, Part 424 Preparation and Processing 

Operations, Use of food ingredients and sources of radiation.

8. Conner, D.E., V.N. Scott, D.T. Bernard and D.A. Kautter, 1989. Potential 

Clostridium botulinum hazards associated with extended shelf-life refrigerated 

foods: A review. J. Food Safety 10:131-153.

9. Davis, H., J.P. Taylor, J.N. Perdue, G.N. Stelma, Jr., J.M. Humphreys, Jr., R. 

Roundtree III, and K.D. Greene, 1988. A shigellosis outbreak traced to 

commercially distributed shredded lettuce. Am. J. Epidemiol. 128(6):1312-1321.

10.Doyle, M. P. 1991. Evaluating the potential risk from extended shelf-life 

refrigerated foods by Clostridium botulinum inoculation studies. Food Tech.

154-156.

11.Farber, J.M. and K.L. Dodd’s (Eds.). 1995. Principles of Modified – Atmosphere 

and Sous Vide Product Packaging. Technomic Publishing Company, Inc., 

Lancaster, PA 17604.

12.Gill, C.O. and K.M. Delacy, 1991. Growth of Escherichia coli and Salmonella 

typhimurium on high-pH beef packaged under vacuum or carbon dioxide. Int. J. 

Food Microbiol. 13:21-30.

13.Glass, K.A. and E.A. Johnson. 2004. Factors that contribute to the botulinal 

safety of reduced-fat and fat-free process cheese products. J. Food Prot. 

67:1687-1693.

14.Gould, G.W. 1999. Sous vide foods: Conclusions of an ECFF botulinum working 

party. Food Control 10. 47-51.

15.Grau, F.H. and P.B. Vanderline, 1990. Growth of Listeria monocytogenes on 

vacuum packaged beef. J. Food Prot. 53:739-741, 746.

16.Johnson, E.A., J.H. Nelson, and M. Johnson. 1990. Microbiology safety cheese 

made from heat-treated milk, Part 1 Executive summary, introduction and history. 

J. Food Prot. 53:441-452.

17.Juneja, Vijay, Stefan T. Martin and Gerald M. Sapers, 1998. Control of Listeria 

monocytogenes in Vacuum-Packaged Pre-Peeled Potatoes. J. Food Science 

63(5):911-914.
FDA Food Code 2022 Annex 2. References

Annex 2 - 51

18.Kautter, D.A., 1964. Clostridium botulinum type E in smoked fish. J. Food Sci. 

29:843-849.

19.Marth, Elmer H., 1998. Extended Shelf Life Refrigerated Foods: Microbiological 

Quality and Safety. Food Technology 5(2):57-62.

20.National Advisory Committee on Microbiological Criteria for Foods. 1990. 

Refrigerated foods containing cooked, uncured meat or poultry products that are 

packaged for extended refrigerated shelf life and that are ready-to-eat or 

prepared with little or no additional heat treatment. Washington, DC, found at 

National Advisory Committee on Microbiological Criteria for Foods (NACMCF) | 

Food Safety and Inspection Service (usda.gov)..

21.New York Department of Agriculture and Markets, 1993. Guidelines for Reduced 

Oxygen Packaging at Retail. Division of Food Safety and Inspection, 1 Winners 

Circle, Albany, NY 12235, 2 pp.

22.Nolan, D.A., D.C. Chamblin, and J.A. Troller, 1992. Minimal water activity for 

growth and survival of Listeria monocytogenes and Listeria innocua. Int. J. 

Food Microbiol. 16:323-335.

23.Olarte, C., E. González-Fandos, M.Giménez, S. Sanz and J. Portu. 2002. The 

growth of Listeria monocytogenes in fresh goat cheese (Cameros cheese) 

packaged under modified atmospheres. Food Microbiol. 19, 75-82.

24.Peck, M.W, Goodburn, K.E., Betts, R.P., and Stringer, S.C. 2008. Assessment of 

the potential for growth and neurotoxin formation by non-proteolytic Clostridium 

botulinum in short shelf-life commercial foods designed to be stored chilled. 

Trends in Food Science & Technology. 19:207-216.

25.Pourshafie, M.R., M. Saifie, A. Shafiee, P. Vahdani, M. Aslani, and J.Salemian. 

1998. An outbreak of food-borne Botulism associated with contaminated locally 

made cheese in Iran. Scand. J. Infect. 30:92-94.

26.Refrigerated Foods and Microbiological Criteria Committee of the National Food 

Processors Association, 1988. Factors to be Considered in Establishing Good 

Manufacturing Practices for the Production of Refrigerated Foods. Dairy and 

Food Sanitation, 8(6):288-291.

27.Refrigerated Foods and Microbiological Criteria Committee of the National Food 

Processors Association, 1988. Safety Considerations for New Generation 

Refrigerated Foods. Dairy and Food Sanitation, 8(1):5-7.

28.Skinner, G.E, Larkin, J.W. 1998. Conservative Prediction of Time to clostridium 

botulinum Toxin Formation for Use with Time-Temperature Indicators To Ensure 

the Safety of Foods. Journal of Food Protection, 61(9):1154-1160.
FDA Food Code 2022 Annex 2. References

Annex 2 - 52

29.Smelt, J.P.P., G.J.M. Raatjes, J.S. Crowther, and C.T. Verrips. 1981. Growth and 

toxin formation by Clostridium botulism at low pH values. J. Appl. Bact. 52:75-

82.

30.Townes, J. M., P. R. Cieslak, MD., C. L. Hatheway, PhD., H.M. Solomon, MS., J. 

T. Holloway, MD., M. P. Baker, MD., C. F. Keller, BS., L. M. McCrosky, BS., and 

P.M.

31.Griffin, MD. 1996. An outbreak of Type A Botulism associated with a commercial 

cheese sauce. Ann. Int. Med. 125:558-563.

32.Whitley, E., D. Muir and W.M. Waites. 2000. The growth of Listeria 

monocytogenes in cheese packed under a modified atmosphere. J. of Appl. 

Microbiol. 88, 52-57.

3-601.11 Standards of Identity.

3-601.12 Honestly Presented.

3-602.11 Food Labels.

3-602.12 Other Forms of Information.

3-603.11 Consumption of Raw or Undercooked Animal Foods.

1. Centers for Disease Control, 1993. Update: Multistate outbreak of Escherichia 

coli O157:H7 infections from hamburgers - western United States, 1992,1993. 

Morb. Mortal. Wkly. Rep. 42(14):258-263. 

2. Code of Federal Regulations, Title 9, Part 319 Definitions and standards of 

identity or composition.

3. Code of Federal Regulations, Title 21, Part 101 – Food labeling.

4. Code of Federal Regulations, Title 9, Part 317 Labeling, marking devices, and 

containers.

5. Federal Food, Drug, and Cosmetic Act, Sec. 403(q)(3)-(5), nutrition labeling.

6. Morris, J.G., Jr. 1988. Vibrio vulnificus: A new monster of the deep? Ann. 

Intern. Med. 109:261-263.

7. Potter, M.E., A.F. Kauffmann, P.A. Blake and R.A. Feldman, 1984. 

Unpasteurized milk: The hazards of a health fetish. J. Am. Med. Assoc.

252:2048-2052.

8. St. Louis, M., et al. 1988. The emergence of Grade A eggs as a major source of 

Salmonella enteritidis infections. J. Am. Med. Assoc. 259:2103-2107.
FDA Food Code 2022 Annex 2. References

Annex 2 - 53

9. Tacket, C.O., L.B. Dominguez, H.J. Fisher, and M.L. Cohen, 1985. An outbreak 

of multiple-drug-resistant Salmonella enteritidis from raw milk. J. Am. Med. 

Assoc. 253:2058-2060. 

3-801.11 Pasteurized Foods, Prohibited Reservice, and Prohibited Food. 

1. Besser, R.E., S.M. Lett, J.T. Webber, M.P. Doyle, T.J. Barrett, J.G. Wells, and 

P.M. Griffin, 1993. An Outbreak of Diarrhea and Hemolytic Uremic Syndrome 

From Escherichia coli O157H:7 in Fresh-Pressed Apple Cider. J. Am. Med. 

Assoc., 269(17):2217-2220.

2. Code of Federal Regulations, Title 21, Part 120 Hazard Analysis and Critical 

Control Point (HACCP): Procedures for the Safe and Sanitary Processing and 

Importing of Juice, found at http://www.ecfr.gov/cgi-bin/textidx?c=ecfr&SID=370071ae0a9a1e0ebcee093fcf6f088a&rgn=div5&view=text&no

de=21:2.0.1.1.17&idno=21

3. Conner, D.E., and J.S. Kotrola. Growth and Survival of Escherichia coli

O157H:7 under Acidic Conditions. Applied and Environmental Microbiology, 

January, 1995, pp. 382-385.

4. Goverd, K.A., F.W. Beech, R.P. Hobbs and R. Shannon, 1979. The occurrence 

and survival of coliforms and salmonellas in apple juice and cider. J. Appl. 

Bacteriol. 46:521-530.

5. Humphrey, T.J., K.W. Martin, and A. Whitehead. 1994. Contamination of hands 

and work surfaces with Salmonella enteritidis PT4 during the preparation of 

egg dishes. Epidemiol. Infect. 113: 403-409.

6. Miller, L.G., and C.W. Kaspar, 1994. Escherichia coli O157:H7 Acid Tolerance 

and Survival in Apple Cider. J. Food Pro. 57(6):460-464.

7. Zhao, T., M.P. Doyle and R.E. Besser, 1993. Fate of enterohemorrhagic 

Escherichia coli O157:H7 in apple cider with and without preservatives. Appl. 

Environ. Microbiol. 59(8): 2526-2530. 

Chapter 4. Equipment, Utensils, and Linens

4-101.13 Lead, Use Limitation. 

1. Food and Drug Administration, 2003. COMPLIANCE PROGRAM GUIDANCE 

MANUAL, PROGRAM 7304.019, Toxic Elements in Food and Foodware, and 

Radionuclides in Food – Import and Domestic, CHAPTER 04 – PESTICIDE AND 

CHEMICAL CONTAMINANTS, found at: 

http://www.fda.gov/Food/ComplianceEnforcement/FoodCompliancePrograms/uc

m071496.htm
FDA Food Code 2022 Annex 2. References

Annex 2 - 54

2. Food and Drug Administration, 1995. Compliance Policy Guide Section 545.450 

Pottery (Ceramics); Imported and Domestic – Lead Contamination (CPG 

7117.07), found at: 

http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManu

al/ucm074516.htm

3. Food and Drug Administration, 1998. Dangers of Lead Still Linger. FDA 

Consumer, January-February 1998.

4-101.14 Copper, Use Limitation.

1. Low, B.A., J.M. Donahue, and C.B. Bartley, 1996. FINAL REPORT - A STUDY 

ON BACKFLOW PREVENTION ASSOCIATED WITH CARBONATORS. NSF, 

International, Ann Arbor, MI. pp. 18-20.

2. Peterson, C.S., 1979. Microbiology of Food Fermentation, 2nd Ed. AVI 

Publishing Co., Inc., Westport, Connecticut, pp. 288-293.

4-101.16 Sponges, Use Limitation. 

1. Enriquez, C.E., R. Enriquez-Gordillo, D.I. Kennedy, and C.P. Gerba, January, 

1997. Bacteriological Survey of Used Cellulose Sponges and Cotton Dishcloths 

from Domestic Kitchens. Dairy, Food and Environmental Sanitation, Vol. 17, No. 

1, pp. 20-24. 

4-101.17 Wood, Use Limitation. 

1. Abrishami, S.H., B.D. Tall, T.J. Bruursema, P.S. Epstein and D.B. Shah. 

Bacterial Adherence and Viability on Cutting Board Surfaces. Department of 

Microbiology, NSF International, Ann Arbor, MI and Division of Microbiological 

Studies, Center for Food Safety and Applied Nutrition, U.S. Food and Drug 

Administration, Washington, D.C. Journal of Food Safety 14 (1994) 153-172.

2. Agricultural Research Service, U.S. Department of Agriculture. ARS Affirms 

Plastic Cutting Board Policies. Food Chemical News, December 6, 1993, pp. 56-

57.

3. Code of Federal Regulations, Title 21, Part 178.3800 Preservatives for wood. 

4-204.13 Dispensing Equipment, Protection of Equipment and Food.

1. NSF/ANSI 18-2007 Manual Food and Beverage Dispensing Equipment. NSF 

International, http://www.nsf.org
FDA Food Code 2022 Annex 2. References

Annex 2 - 55

4-501.13 Microwave Ovens. 

1. Code of Federal Regulations, Title 21, Part 1030.10 Microwave ovens. 

4-501.114 Manual and Mechanical Warewashing Equipment, Chemical 

Sanitization - Temperature, pH, Concentration, and Hardness. 

1. Code of Federal Regulations, Title 21, Part 1030.10 Microwave ovens.

2. Code of Federal Regulations, Title 40, Part 180.940 Tolerance exemptions for 

active and inert ingredients for use in antimicrobial formulations (food-contact 

surface sanitizing solutions), found at 

http://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR

3. Code of Federal Regulations, Title 40 Part 152.500 Pesticide registration and 

classification procedures, Requirements for devices found at 

http://edocket.access.gpo.gov/cfr_2009/julqtr/pdf/40cfr152.500.pdf

4. Code of Federal Regulations, Title 40 Part 156.10 Labeling requirements for 

pesticides and devices found at 

http://edocket.access.gpo.gov/cfr_2009/julqtr/pdf/40cfr156.10.pdf

5. EPA's Good Laboratory Practices Standards (GLPS) found at 

http://www.epa.gov/compliance/monitoring/programs/fifra/glp.html

6. Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Sections 2(q)(1) and 

12 found at http://www.epa.gov/pesticides/regulating/laws.htm

7. Miller, M.P., Principal Investigator, 1984. Relationship of Factors Affecting 

Bactericidal Effectiveness of Chlorine Sanitizing Solutions. Final Report. National 

Sanitation Foundation, Ann Arbor, MI., subcontract No. 9013-092-108-H0620-

101; Booz, Allen & Hamilton, Inc. contract No. 223-80-2295.

8. Miller, M.P., Principal Investigator, 1985. Relationship of Factors Affecting 

Bactericidal Effectiveness of Chlorine Sanitizing Solutions. Addendum to Final 

Report. National Sanitation Foundation, Ann Arbor, MI., subcontract No. 9013-

092-108-H0620-101; Booz, Allen & Hamilton, Inc. contract No. 223-80-2295.

9. National Sanitation Foundation, Ann Arbor, MI. November, 1990. Report on the 

Bacterial Effectiveness of a Chlorine Sanitizing Solution at Contact Times of Less 

than Ten Seconds. Purchase Order #FDA 665531-00-90-RB
FDA Food Code 2022 Annex 2. References

Annex 2 - 56

4-602.11 Equipment Food-Contact Surfaces and Utensils. 

1. Tauxe, R.V., M.D., Chief, Foodborne and Diarrheal Diseases Branch, Division of 

Bacterial and Mycotic Diseases, National Center for Infectious Disease and M.L. 

Cohen, M.D., Director, Division of Bacterial and Mycotic Diseases, National 

Center for Infectious Diseases, memo dated January 10, 1996 re: "Bacterial 

Contamination of Iced Tea," to State and Territorial Epidemiologists and State 

and Territorial Public Health Laboratory Directors. Memo includes two fact sheets 

by the Tea Association of the U.S.A., Inc. 

4-703.11 Hot Water and Chemical. 

1. Miller, M.P., Principal Investigator, 1984. Relationship of Factors Affecting 

Bactericidal Effectiveness of Chlorine Sanitizing Solutions. Final Report. National 

Sanitation Foundation, Ann Arbor, MI., subcontract No. 9013-092-108-H0620-

101; Booz, Allen & Hamilton, Inc. contract No. 223-80-2295.

2. Miller, M.P., Principal Investigator, 1985. Relationship of Factors Affecting 

Bactericidal Effectiveness of Chlorine Sanitizing Solutions. Addendum to Final 

Report. National Sanitation Foundation, Ann Arbor, MI., subcontract No. 9013-

092-108-H0620-101; Booz, Allen & Hamilton, Inc. contract no. 223-80-2295.

3. National Sanitation Foundation, Ann Arbor, MI. November, 1990. Report on the 

Bacterial Effectiveness of a Chlorine Sanitizing Solution at Contact Times of Less 

than Ten Seconds. Purchase Order #FDA 665531-00-90-RB. 

4-901.11 Equipment and Utensils, Air-Drying Required. 

1. Code of Federal Regulations, Title 40, Part 180.940 Tolerance Exemptions for 

Active and Inert Ingredients for Use in Antimicrobial Formulations (food-contact 

surface sanitizing solutions), before contact with food. 

Chapter 5. Water, Plumbing, and Waste

1. Code of Federal Regulations, Title 40, Part 180.940 Tolerance Exemptions for 

Active and Inert Ingredients for Use in Antimicrobial Formulations (food-contact 

surface sanitizing solutions), before contact with food.

2. Code of Federal Regulations, Title 21, Part 129 – Processing and Bottling of 

Bottled Drinking Water.

3. International Association of Plumbing and Mechanical Officials, 2003 Uniform 

Plumbing Code, Walnut, CA. Available for sale at 

http://publications.iapmo.org/categories.asp?id=1
FDA Food Code 2022 Annex 2. References

Annex 2 - 57

4. International Code Council. 2003 International Plumbing Code, Falls Church, VA. 

Available for sale at https://www.iccsafe.org/codes-tech-support/topics/plumbingmechanical-and-fuel-gas/international-plumbing-code-ipc-home-page/

5-102.12 Nondrinking Water.

1. FDA, Program Information Manual, Retail Food Protection, Storage and Handling 

of Tomatoes, posted 10/05/07, updated 09/25/08. Available at: 

http://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/IndustryandR

egulatoryAssistanceandTrainingResources/ucm113843.htm

2. FDA, Guide to Minimize Microbial Food Safety Hazards for Fresh-cut Fruits and 

Vegetables, posted 10/26/98, updated 08/19/03, 02/2008. Available at: 

http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInf

ormation/ProducePlantProducts/ucm064458.htm

5-202.12 Handwashing Facility, Installation. 

1. American Society for Testing and Materials, Designation: E 1838-02, Standard 

Test Method for Determining the Virus-Eliminating Effectiveness of Liquid 

Hygienic Handwash and Handrub Agents Using the Fingerpads of Adult 

Volunteers. ASTM, Philadelphia, PA.

2. American Society for Testing and Materials, Designation: E 2011-99, Standard 

Test Method for Evaluation of Handwashing Formulations for Virus-Eliminating 

Activity Using the Entire Hand. ASTM, Philadelphia, PA.

3. American Society for Testing and Materials, Designation: E 1327-90 (reapproved 

2000), Standard Test Method for Evaluation of Health Care Personnel Handwash 

Formulations by Utilizing Fingernail Regions. ASTM, Philadelphia, PA.

4. American Society for Testing and Materials, Designation: E 1174-00, Standard 

Test Method for Evaluation of Health Care Personnel or Consumer Handwash 

Formulations. ASTM, Philadelphia, PA.

5. Code of Federal Regulations, Title 21, Part 129 Processing and Bottling of 

Drinking Water. 

5-203.13 Service Sink.

1. Barker, J. and Bloomfield, S. F., 2000. Survival of Salmonella in bathrooms and 

toilets in domestic homes following salmonellosis. Journal of Applied 

Microbiology, 89, 137-144.

2. Barker, J. and Jones, M.V., 2005. The potential spread of infection caused by 

aerosol contamination of surfaces after flushing a domestic toilet. Journal of 

Applied Microbiology, 99, 339-347.
FDA Food Code 2022 Annex 2. References

Annex 2 - 58

3. Barker, J., Vipond, I. B, and Bloomfield, S. F., 2004. Effects of cleaning and 

disinfection in reducing the spread of Norovirus contamination via environmental 

surfaces. Journal of Hospital Infection, 58, 42-49.

4. Cheesbrough, J. S., Green, J., Gallimore, C. I., and Wright, P.A., 2000. 

Widespread environmental contamination with Norwalk-like viruses (NLV) 

detected in a prolonged hotel outbreak of gastroenteritis. Epidemiol. Infect., 125, 

93-98.

5. Gerba, C. P., C. Wallis, and J.L. Melnick, 1975. Microbiological Hazards of 

Household Toilets: Droplet Production and the Fate of Residual Organisms. Appl. 

Microbiology, 30(2):229-237.

6. Mokhtari, A. and Jaykus, L. (2009). Quantitative exposure model for the 

transmission of norovirus in retail food preparation. International Journal of Food 

Microbiology, 133 (1-2), 38-47. 

5-203.15 Backflow Prevention Device, Carbonator.

1. American Society of Sanitary Engineering, ASSE Product Performance 

Standards , Standard 1022. ASSE International Office, 901 Canterbury, Suite A, 

Westlake, OH 44145. Available at: http://www.asse-plumbing.org/standards.html

Chapter 6 Physical Facilities

6-202.15 Outer Openings, Protected. 

1. National Fire Protection Association, NFPA 101 Life Safety Code, 2009 Edition, 

Quincy, MA. Available for sale at: 

http://www.nfpa.org/aboutthecodes/aboutthecodes.asp?docnum=101

2. National Fire Protection Association, NFPA 101 Life Safety Code Handbook, 

2009 Edition, Quincy, MA. 

6-303.11 Intensity. 

1. Illuminating Engineering Society of North America, 2000. Lighting Handbook, 9th 

Ed., IESNA Publications Dept., New York, NY. 900+ pp. 
FDA Food Code 2022 Annex 2. References

Annex 2 - 59

6-301.12 Hand Drying Provision

1. D. R. Patrick, G. Findon and T. E. Miller (1997). Residual moisture determines 

the level of touch-contact-associated bacterial transfer following hand washing. 

Epidemiology and Infection, 119, pp 319-325 .

6-501.18 Cleaning Plumbing Fixtures

1. Barker, J. and Bloomfield, S. F., 2000. Survival of Salmonella in bathrooms and 

toilets in domestic homes following salmonellosis. Journal of Applied 

Microbiology, 89, 137-144.

2. Barker, J. and Jones, M.V., 2005. The potential spread of infection caused by 

aerosol contamination of surfaces after flushing a domestic toilet. Journal of 

Applied Microbiology, 99, 339-347.

3. Barker, J., Vipond, I. B, and Bloomfield, S. F., 2004. Effects of cleaning and 

disinfection in reducing the spread of Norovirus contamination via environmental 

surfaces. Journal of Hospital Infection, 58, 42-49.

4. Cheesbrough, J. S., Green, J., Gallimore, C. I., and Wright, P.A., 2000. 

Widespread environmental contamination with Norwalk-like viruses (NLV) 

detected in a prolonged hotel outbreak of gastroenteritis. Epidemiol. Infect., 125, 

93-98.

5. Gerba, C. P., C. Wallis, and J.L. Melnick, 1975. Microbiological Hazards of 

Household Toilets: Droplet Production and the Fate of Residual Organisms. Appl. 

Microbiology, 30(2):229-237.
FDA Food Code 2022 Annex 2. References

Annex 2 - 60

6-501.111 Controlling Pests

1. Monica Pava-Ripoll, Rachel E. Goeriz Pearson, Amy K. Miller, and George C. 

Ziobro. 2012. Prevalence and Relative Risk of Cronobacter spp., Salmonella 

spp., and Listeria monocytogenes Associated with the Body Surfaces and 

Guts of Individual Filth Flies. Applied and Environmental Microbiology 78 (22): 

7891-7902. http://aem.asm.org/content/78/22.toc?etoc

Chapter 7. Poisonous or Toxic Materials

7-202.12 Conditions of Use. 

1. Federal Insecticide, Fungicide, and Rodenticide Act, 7 USC 136 Definitions, (e) 

Certified Applicator, of the Federal Insecticide, Fungicide, and Rodenticide Act 

found at http://www.epa.gov/opp00001/regulating/fifra.pdf. 

7-204.11 Sanitizers, Criteria. 

1. Code of Federal Regulations, Title 40, Part 180.940 Tolerance exemptions for 

active and inert ingredients for use in antimicrobial formulations (Food-contact 

surface sanitizing solutions) found at:

http://edocket.access.gpo.gov/cfr_2010/julqtr/pdf/40cfr180.940.pdf

2. Code of Federal Regulations, Title 40 Part 180.2020 Pesticide Chemicals Not 

Requiring a Tolerance or an Exemption From Tolerance-Non-Food 

determinations found at: 

http://edocket.access.gpo.gov/cfr_2010/julqtr/pdf/40cfr180.2020.pdf

3. Code of Federal Regulations, Title 29 Part 1910.1000 Occupational Safety and 

Health Standards found at:

http://edocket.access.gpo.gov/cfr_2010/julqtr/pdf/29cfr1910.1000.pdf

7-204.12 Chemicals for Washing Fruits and Vegetables, Criteria. 

1. Code of Federal Regulations, Title 21, Part 173.315, Chemicals used in washing 

or to assist in the peeling of fruits and vegetables. 

2. Code of Federal Regulations, Title 21, Part 173.405, Secondary Direct Food 

Additives Permitted in Food for Human Consumption; Sodium 

Dodecylbenzenesulfonate.
FDA Food Code 2022 Annex 2. References

Annex 2 - 61

7-204.13 Boiler Water Additives, Criteria. 

1. Code of Federal Regulations, Title 21, Part 173.310, Boiler water additives. 

7-204.14 Drying Agents, Criteria. 

1. Code of Federal Regulations, Title 21, Part 184, Direct Food Substances 

Affirmed as Generally Recognized as Safe. 

2. Code of Federal Regulations, Title 21, Parts 175, Indirect Food Additives: 

Adhesives and Components of Coatings. 

3. Code of Federal Regulations, Title 21, Parts 178, Indirect Food Additives: 

Adjuvants, Production Aids, and Sanitizers. 

4. Code of Federal Regulations, Title 21, Parts 176, Indirect Food Additives: Paper 

and Paperboard Components. 

5. Code of Federal Regulations, Title 21, Parts 177, Indirect Food Additives: 

Polymers. 

6. Code of Federal Regulations, Title 21, Part 186, Indirect Food Substances 

Affirmed as Generally Recognized as Safe. 

7. Code of Federal Regulations, Title 21, Part 181, Prior-Sanctioned Food 

Ingredients. 

8. Code of Federal Regulations, Title 21, Part 182, Substances Generally 

Recognized as Safe. 

9. Code of Federal Regulations, Title 21, Part 170.39, Threshold of regulation for 

substances used in food-contact articles.

10.Code of Federal Regulations, Title 21, Part 170.30, Eligibility for classification as 

generally recognized as safe (GRAS)

11.Code of Federal Regulations, Title 21, Part 174, Indirect Food Additives: 

General.

12.Federal Food Drug and Cosmetic Act, Section, 409 (h), 

http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosm

eticActFDCAct/default.htm

13.Federal Food Drug and Cosmetic Act, Section 201(s)(4) 

http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosm

eticActFDCAct/default.htm

14.Food Contact Notification, Ingredients and Packaging, 

http://www.fda.gov/Food/IngredientsPackagingLabeling/default.htm
FDA Food Code 2022 Annex 2. References

Annex 2 - 62

7-205.11 Incidental Food Contact, Criteria. 

1. Code of Federal Regulations, Title 21, Part 178.3570, Lubricants with incidental 

food contact. 

7-206.11 Restricted use Pesticides, Criteria. 

1. Code of Federal Regulations, Title 40, Part 152 Subpart I, Classification of 

Pesticides.

3. Supporting Documents

FDA is providing the following guidance documents for reference. A brief summary for 

each document is provided. 

A. Voluntary National Retail Food Regulatory Program Standards

B. FDA Procedures for Standardization and Certification of Retail Food 

Inspection/Training Officers

C. Managing Food Safety: A Manual for the Voluntary Use of HACCP 

Principles for Operators of Food Service and Retail Establishments

D. Managing Food Safety: A Regulator’s Manual for Applying HACCP 

Principles to Risk-based Retail and Food Service Inspections and 

Evaluating Voluntary Food Safety Management Systems

E. Food Establishment Plan Review Guide

F. FDA Report on the Occurrence of Foodborne Illness Risk Factors in 

Selected Institutional Foodservice, Restaurant, and Retail Food Store 

Facility Types (2004)

G. Growing Sprouts in a Retail Food EstablishmentGrowing Sprouts in a 

Retail Food Establishment

H. Advisories for Retail Processing with Proper Controls and Variances for 

Product Safety

I. Evaluation and Definition of Potentially Hazardous Foods

J. The U.S. Equal Employment Opportunity Commission (EEOC) Guide, 

“How to Comply with the Americans with Disabilities Act: A Guide for 

Restaurants and Other Food Service Employers” October 28, 2004

K. Requirements and Guidance for Retail Facilities Regarding Beef Grinding 

Logs Tracking Supplier Information
FDA Food Code 2022 Annex 2. References

Annex 2 - 63

L. Recommended Guidelines for Permanent Outdoor Cooking 

Establishments, 2003

M. Comprehensive Guidelines for Food Recovery Programs

N. Retail Food Protection Program Information Manual: Storage and 

Handling of Tomatoes, 2007

O. Retail Food Protection Program Information Manual: Recommendations to 

Food Establishments for Serving or Selling Cut Leafy Greens

P. Employee Health and Personal Hygiene Handbook

Q. Risk Assessment Process and Spreadsheet to Redesignate Food Code 

Provisions

R. Parameters for Determining Inoculated Pack/Challenge Study Protocols

S. The Council to Improve Foodborne Outbreak Response (CIFOR) –

Guidelines for Foodborne Outbreak Response

T. CIFOR Foodborne Illness Response Guidelines for Owners, Operators, 

and Managers of Food Establishments (CIFOR Industry Guidelines)

U. Sanitation Practices Standard Operating Procedures and Good Retail 

Practices to Minimize Contamination and Growth of Listeria 

Monocytogenes with Food Establishments, 2nd Edition

V. The Bad Bug Book, 2nd Edition Foodborne Pathogenic Microorganisms 

and Natural Toxins Handbook

W. Minimizing the Risk of Campylobactor and Salmonella Illnesses 

Associated with Chicken Liver

X. Guidance Document for Direct to Consumer and Third Party Delivery 

Service Food Delivery

Y. Whole Roaster Pigs: Guidance for the Safe Handling and Cooking

Z. National Shellfish Sanitation Program (NSSP) Guide for the Control of 

Molluscan Shellfish
FDA Food Code 2022 Annex 2. References

Annex 2 - 64

Summary of Supporting Documents

A. Voluntary National Retail Food Regulatory Program Standards

This document can be accessed at the following web site: 

http://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/ProgramStandards/

default.htm and was formulated from ideas and input by Federal, State, and local 

regulatory officials, industry, trade and professional associations, academia, and 

consumers. The purposes of these standards are: 

• To serve as a bench mark to retail food regulatory program managers in the 

design and management of a retail food program;

• To provide a means of recognition of programs meeting these standards;

• To promote uniformity in retail food programs to reduce the risk factors known to 

cause foodborne illness;

• To provide a foundation for the food regulatory program that is focused on the 

risk factors and other factors that may contribute to foodborne illness; and

• To promote, through the management of a retail food regulatory program, the 

active managerial control in the retail establishment of all the factors that may 

cause foodborne illness.

• Further purposes of these standards are to serve as a guide to regulatory retail 

food program managers in the design and management of a retail food program 

and to provide a means of recognition for those programs that meet these 

standards. 

• The intent in the development of these standards is to establish a basic 

foundation in design and management of a retail food program. Program 

management may add additional requirements to meet individual program needs. 

• The standards apply to the operation and management of a regulatory retail food 

program focused on the reduction of risk factors known to cause foodborne 

illness as well as other factors that may contribute to foodborne illness and on 

the promotion of active managerial control of all factors that may cause 

foodborne illness.

B. FDA Procedures for Standardization and Certification of Retail Food

Inspection/Training Officers

This document can be found by accessing the following web site: 

https://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/Standardization/de

fault.htm

This is a procedure that integrates the assessment of an individual's knowledge, skills, 

and abilities in a manageable number of inspections while preserving the quality and 

integrity of the process. At the same time, we continue to learn from our experiences in 

applying it and remain open to improving these Procedures based on your experiences 

and feedback.

As they are written, the Procedures address the situation wherein an FDA Standard is 

assessing a CANDIDATE who is not employed by FDA. For example, Paragraph 

3-301(C) mentions but does not require recording citations (i.e., identifying the codified 

provision that relates to each observed violation). Since jurisdiction's codification 
FDA Food Code 2022 Annex 2. References

Annex 2 - 65

systems (numeric or alphanumeric) are usually different from the system in the FDA 

Food Code, the utility of that practice would be minimal in an FDA-to-jurisdiction field 

exercise. However, within a jurisdiction where the same Code is in use, the practice 

could be useful in reinforcing diligence in ensuring that violations listed during 

inspections are, in fact, soundly based in regulation.

FDA invites and encourages jurisdictions to use these Procedures in their internal 

Standardization and Certifications and to add dimensions that promote uniformity such 

as citing codified provisions, as discussed above. With a few language changes, the 

document can be custom-tailored to fit individual jurisdictions and serve as their 

procedures. As with other documents provided as guidance for applying regulatory 

requirements in the retail sector, these Procedures are in the "public domain" and we 

encourage their duplication and use.

C. Managing Food Safety: A Manual for the Voluntary Use of HACCP Principles 

for Operators of Food Service and Retail Establishments

The Operator’s Manual can be found by accessing the following web site: 

http://www.fda.gov/Food/GuidanceRegulation/HACCP/ucm2006811.htm. FDA has 

issued guidance to industry in voluntarily applying HACCP principles in food 

establishments. It recognizes that there are differences between using HACCP at retail 

and in food manufacturing. By incorporating the seven principles of HACCP, a good set 

of Standard Operating Procedures, and using a process approach, this Guide sets up a 

framework for the retail food industry to develop and implement a sound food safety 

management system. 

This document is intended to serve as a guide in the writing of a simple plan based on 

HACCP principles that can be used to manage food safety. It is very important to 

understand that this Guide is intended to assist industry's voluntary implementation of 

HACCP principles. It is not meant to stand alone, but instead should be used together 

with advice from and in consultation with your Federal, State, local, or tribal food safety 

regulatory authority. The regulatory authority is an important resource for reviewing your 

food safety management system. Regulatory food safety professionals can provide 

important information for the public health rationale for controlling a particular hazard. 

Users of this document also need to consult and use the latest edition of the FDA Food 

Code since many of its requirements are not reproduced here but constitute a 

fundamental program that is prerequisite to implementing a HACCP program. 

Hazard Analysis Critical Control Point (HACCP) is a common sense technique to control 

food safety hazards. It is a preventive system of hazard control rather than a reactive 

one. Food establishments can use it to ensure safer food products for consumers. It is 

not a zero risk system, but is designed to minimize the risk of food safety hazards. 

HACCP is not a stand alone program but is one part of a larger system of control 

procedures that must be in place in order for HACCP to function effectively. These 

control procedures are prerequisite programs and are discussed more in Annex 4. 

The success of a HACCP program is dependent upon both people and facilities. 

Management and employees must be properly motivated and trained if a HACCP 

program is to successfully reduce the risk of foodborne illness. Education and training in 

the principles of food safety and management commitment to the implementation of a 
FDA Food Code 2022 Annex 2. References

Annex 2 - 66

HACCP system are critical and must be continuously reinforced. Instilling food worker 

commitment and dealing with problems such as high employee turnover and 

communication barriers must be considered when designing a HACCP plan. 

Successful implementation of a HACCP plan is also dependent upon the design and 

performance of facilities and equipment. The likelihood of the occurrence of a hazard in 

a finished product is definitely influenced by facility and equipment design, construction, 

and installation that play a key role in any preventive strategy. 

The Agency recognizes that this document has areas that need to be further clarified 

and developed with broader input and based on industry’s experiences with the 

practicalities of integrating the HACCP approach in their operations. This Guide will 

continue to evolve and improve. 

D. Managing Food Safety: A Regulator’s Manual for Applying HACCP Principles 

to Risk-based Retail and Food Service Inspections and Evaluating Voluntary 

Food Safety Management Systems

The Regulator’s Manual can be found by accessing the following website: 

http://www.fda.gov/Food/GuidanceRegulation/HACCP/ucm2006812.htm. This 

document provides State, local, and tribal regulatory authorities with a step-by-step 

scheme for conducting risk-based inspections based on HACCP principles to assist 

them with identifying and assessing control of foodborne illness risk factors. In 

addition,the manual details intervention strategies that can be developed with retail and 

food service operators to reduce the occurrence of foodborne illness risk factors. It also 

provides recommendations for evaluating voluntarily-implemented food safety 

management systems if invited to do so by industry. 

The utilization of voluntary food safety management systems by industry and the 

incorporation of risk-based methodology into regulatory inspection programs are 

important elements in reaching the goals established by the Healthy People 2010 health 

improvement strategy and FDA retail program goals. 

In 2004, the Conference for Food Protection (CFP) endorsed both documents with a 

recommendation that both industry and regulatory entities consider implementing the 

principles of the documents into their respective food safety programs. The CFP is 

composed of regulators, industry, academia, professional organizations, and consumers 

whose purpose is to identify problems, formulate recommendations, and develop and 

implement practices that relate to food safety. 

A Federal Register notice announcing the availability of these documents was published 

July 21, 2005 (Docket No. 2005D-0274). 

E. Food Establishment Plan Review Guide

This document can be found at: 

http://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/IndustryandRegulat

oryAssistanceandTrainingResources/ucm101639.htm. This Food Establishment Plan 

Review document has been developed for the purpose of assisting both regulatory and 

industry personnel in achieving greater uniformity in the plan review process. It is the 

result of a joint effort by FDA and the Conference for Food Protection. 
FDA Food Code 2022 Annex 2. References

Annex 2 - 67

Plan review of food service establishments, retail food stores, and all other food

operations, must be maintained as a high priority by all regulatory food agencies for 

both new and existing facilities. 

This document has been developed to serve as a guide in facilitating greater uniformity 

and ease in conducting plan review whether your position is a regulator or an industry 

person wishing to build or to expand. You need not be an expert to effectively complete 

this process. 

A good review of plans helps to avoid future problems. By listing and locating equipment 

on floor plans and diagramming specifications for electrical, mechanical and plumbing 

systems, potential problems can be spotted while still on paper and modifications made

BEFORE costly purchases, installation and construction. 

Food establishment plan review is recognized as an important food program component 

that allows: 

• Regulatory agencies to ensure that food establishments are built or renovated 

according to current regulations or rules. 

• Industry to establish an organized and efficient flow of food.

• Regulatory agencies to eliminate code violations prior to construction. 

F. FDA Report on the Occurrence of Foodborne Illness Risk Factors in Selected 

Institutional Foodservice, Restaurant, and Retail Food Store Facility Types (2004)

In 1998, FDA initiated a project designed to determine the incidence of foodborne 

illness risk factors in retail and food service establishments. Inspections focusing on the 

occurrence of foodborne illness risk factors were conducted in establishments 

throughout the United States. The results of this project are published in the 2000

Report of the FDA Retail Food Program Database of Foodborne Illness Risk Factors, 

commonly referred to as the “FDA Baseline Report.” The Baseline Report is available at 

https://www.fda.gov/food/guidanceregulation/retailfoodprotection/foodborneillnessriskfac

torreduction/default.htm. 

The data collection project was repeated in 2003 and the results are published in the 

FDA Report on the Occurrence of Foodborne Illness Risk Factors in Selected 

Institutional Foodservice, Restaurant, and Retail Food Store Facility Types (2004). This 

second report is available from FDA through the following website: 

https://www.fda.gov/food/guidanceregulation/retailfoodprotection/foodborneillnessriskfac

torreduction/default.htm

G. Growing Sprouts in a Retail Food Establishment 

This document, Growing Sprouts in a Retail Food Establishment, can be found at 

http://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/ucm078758.htm. 

There were 25 reported outbreaks associated with raw and lightly cooked seed sprouts 

in the United States between January 1996 and December 2003. No single treatment 

so far has been shown to completely eliminate pathogens on seeds or sprouts without 

affecting germination or yield; therefore a combination of factors is used to eliminate 

and control potential pathogens and assure a safe, ready-to-eat food product. Seeds or 

beans grown using Good Agricultural Practices (GAPs) and conditioned, transported, 
FDA Food Code 2022 Annex 2. References

Annex 2 - 68

and stored according to GMPs reduce the potential for seed to serve as a source of 

contamination. Retail Sprouting Industry Best Practices help ensure that no further 

contamination occurs and precautionary measures are taken to prevent high levels of 

bacteria from growing on the seeds or sprouts. Seeds for sprouting or sprouts should 

receive a chemical disinfection treatment that has been approved by EPA for reduction 

of pathogens. Other treatments such as irradiation of seeds [21 CFR 179.26(b)(10)] 

have been approved. Because no treatments are known to completely eliminate 

pathogens without adversely affecting germination or yield, microbial testing of spent 

irrigation water from the sprouting process is also necessary to verify that no pathogens 

are present. Raw sprouts are considered time/temperature control for safety food (TCS)

and therefore, require refrigeration. 

H. Advisories for Retail Processing with Proper Controls and Variances for 

Product Safety

These documents are available for purchase at minimum cost from the Association of 

Food and Drug Officials (AFDO) at the website http://www.afdo.org/. These guides were 

funded by USDA through the University of Florida in cooperation with Florida A&M 

University and the Association of Food and Drug Officials and developed by experts 

from academic, regulatory, and industry areas. Nine guideshelp retailers and regulatory 

personnel understand the food safety controls to implement in retail food and food 

service operations in order to process and sell safe food products. They can also be 

used as a reference in applying for or reviewing a variance and HACCP Plan, where 

required, for retail processing of beef jerky, cured and hot smoked sausage, cured and 

smoked ham, fermented and dried sausage, fresh-cut produce, fresh juice, reduced 

oxygen packaging (ROP), smoked seafood, and sushi. 

Each guide provides a definition of terms, a flow diagram, and a detailed check list for 

operations including receiving, food storage, preparation, and display. Information in the 

Appendices helps identify specific food safety hazards associated with that product, 

necessary equipment calibrations, product labeling, recommended record keeping with 

sample log sheets, and a daily SOP check list. Authoritative sources are also 

referenced such as FDA’s “Fish and Fisheries Products Hazards & Controls Guidance” 

and 21 CFR 101 for labeling requirements. 

These guides are not intended to replace or duplicate existing regulations within the 

jurisdictions of the regulatory authority or food establishment but they offer information 

and references for more uniform practices. 

I. Evaluation and Definition of Potentially Hazardous Foods

This document can be found at 

http://www.fda.gov/Food/FoodScienceResearch/SafePracticesforFoodProcesses/ucm0

94141.htm. The Institute of Food Technologists (IFT) prepared and submitted this report 

as part of a contract with FDA. It contains responses to various questions posed by FDA 

about time/temperature control for safety food (TCS food). The IFT reviewed the 

evolution of the term TCS and recommended a change to time/temperature control for 

safety (TCS) food as well as a science-based framework for determining the 

effectiveness of processing technologies that formulate a food so that it is non-TCS.
FDA Food Code 2022 Annex 2. References

Annex 2 - 69

The IFT Science and Technology Expert Panel reviewed the two protocols used by NSF 

International and the American Baking Association for determining if a food is a TCS 

and proposed an alternate approach. The report examines intrinsic factors such as aw, 

pH, redox potential, natural and added antimicrobials and competitive microorganisms, 

and extrinsic factors such as packaging, atmospheres, storage conditions, processing 

steps, and new preservation technologies that influence microbial growth. The report 

also analyzes microbial hazards related to time/temperature control of foods for safety.

The IFT developed a framework that could be used to determine whether a food is a 

TCS food or not. Part of the framework includes two tables that consider the interaction 

of pH and aw in a food, whether the food is raw or heat-treated, whether it is packaged. 

When further product assessment is required, the and application of microbiological 

challenge testing (inoculation studies) is discussed along with pathogen modeling 

programs and reformulation of the food. An extensive reference list is included in the 

report.

J. The U.S. Equal Employment Opportunity Commission (EEOC) Guide, “How to 

Comply with the Americans with Disabilities Act: A Guide for Restaurants and 

Other Food Service Employers” October 28, 2004

The guide is designed to assist restaurants and other food service employers in 

complying with the employment provisions of the Americans with Disabilities Act (ADA). 

The EEOC worked extensively with the Food and Drug Administration in developing this 

new publication. 

Available online at http://www.eeoc.gov/facts/restaurant_guide.html, 

http://www.eeoc.gov/facts/restaurant_guide_summary.html, and http://www.fda.gov, the 

guide covers such topics as how the FDA Food Code provisions about restricting and 

excluding sick employees interact with the ADA’s requirements; types of reasonable 

accommodations, including the use of service animals; and what an employer should do 

if a charge of discrimination is filed against the employer’s business. 

Title I of the ADA, which prohibits employment discrimination against people with 

disabilities in the private sector and State and local governments, and the Rehabilitation 

Act’s prohibitions against disability discrimination in the federal government. The EEOC 

enforces Title VII of the Civil Rights Act of 1964, which prohibits employment 

discrimination based on race, color, religion, sex, and national origin; the Age 

Discrimination in Employment Act, which prohibits discrimination against individuals 40 

years of age or older; the Equal Pay Act; and sections of the Civil Rights Act of 1991.

K. Requirements and Guidance for Retail Facilities Regarding Beef Grinding Logs 

Tracking Supplier Information

This document may be found at the following web site for Questions and Answers 

related to the Final Rule "Records To Be Kept by Official Establishments and Retail 

Stores That Grind Raw Beef Products": https://www.fsis.usda.gov/guidelines/2016-0018

On June 20, 2016, The U.S. Department of Agriculture, Food Safety and Inspection 

Service (USDA-FSIS) published a Federal Register Notice (80 FR 79231) titled Records 

To Be Kept by Official Establishments and Retail Stores That Grind Raw Beef Products, 

available at https://www.federalregister.gov/documents/2015/12/21/2015-
FDA Food Code 2022 Annex 2. References

Annex 2 - 70

31795/records-to-be-kept-by-official-establishments-and-retail-stores-that-grind-rawbeef-products, in which the agency discussed its recordkeeping requirements. 

All retail stores and official establishments that grind raw beef products for sale in 

commerce must maintain the following records:

1. The establishment numbers of the establishments that supply the materials 

used to prepare each lot of raw ground beef product;

2. All supplier lot numbers and production dates;

3. The names of the supplied materials, including beef components and any 

materials carried over from one production lot to the next;

4. The date and time each lot of raw ground beef product is produced; and

5. The date and time when grinding equipment and other related food-contact 

surfaces are cleaned and sanitized.

Of particular concern to the USDA-FSIS is its ability to quickly and adequately traceback 

contaminated product that is in commerce to its source and to remove it from commerce. 

FSIS conducts sampling and microbiological verification testing for Escherichia coli (E. 

coli) O157:H7 in raw ground beef products and source materials at federally inspected 

establishments, retail facilities as well as at import facilities. Some of the products most 

likely to be sampled and tested at retail facilities are: 

• Ground beef products produced from retail steaks and roasts; 

• Manufacturing trimmings derived at retail; 

• Ground beef that is formulated at retail by commingling in-store trim and trim 

from federally inspected establishments; and 

• Irradiated ground beef commingled with non-irradiated meat or poultry. 

In cases where USDA-FSIS identifies adulterated ground beef, and a product recall is 

necessary, grinding logs will facilitate identifying the source of the product and 

narrowing the scope of the recall. 

In addition to the references cited above, the following references also provide 

information: 

1. Federal Meat Inspection Act (21 U.S.C. 642, Recordkeeping requirements). 

2. Code of Federal Regulations, 9 CFR 320.1, Records required to be kept .

3. FSIS’ Industry Guideline for Minimizing the Risk of Shiga ToxinProducing Escherichia coli (STEC) in Beef (including Veal) Processing 

Operations. There is a retail grinding log template (Attachment 2 - Grinder’s 

Log) available in the guideline. It is designed to track the source materials 

used, the products produced and any microbiological independence between 

lots. Establishments are encouraged to use the template as a guide and 

include any additional information in the record to fit their unique production 

processes.
FDA Food Code 2022 Annex 2. References

Annex 2 - 71

L. Recommended Guidelines for Permanent Outdoor Cooking Establishments, 

2003

This document can be found at http://www.foodprotect.org/guides-documents/ . 

Permanent Outdoor Cooking Establishments (POCE) include a wide range of facilities 

from barbecue pits at beach resorts to campfire meals at dude ranches, pig roasts and 

clam bakes, and multi-menu food service sites in amusement and theme parks. It is 

essential that the equipment and physical facility requirements be based upon a menu 

review of the items to be prepared, cooked, held, and served. Many of these POCEs 

are high risk operations engaging in extensive preparation of raw ingredients: processes 

that include the cooking, hot and cold holding, and reheating of time/temperature control 

for safety foods. These guidelines provide the basis on which regulatory authorities can 

evaluate and permit permanent outdoor cooking establishments. 

M. Comprehensive Guidelines for Food Recovery Programs

Food recovery programs collect foods from commercial production and distribution 

channels and redistribute them to people in need. There are food recovery efforts 

carried out by public, private, and nonprofit organizations across the country. The 

primary goal of food recovery programs is to collect safe and wholesome food donated 

from commercial sources to meet the nutritional needs of the hungry.

With bipartisan support, Congress passed the Bill Emerson Good Samaritan Food 

Donation Act in 1996. The Act is designed to encourage the donation of food and 

grocery products to nonprofit organizations such as homeless shelters, soup 

kitchens,and churches for distribution to hungry individuals. The Bill Emerson Good 

Samaritan Food Donation Act promotes food recovery by limiting the liability of donors 

to instances of gross negligence or intentional misconduct. 

The Guidelines are intended to provide guidance to those who want to participate in 

food recovery programs as donors and receiving operations as well as to those who 

oversee standards compliance as regulators or peer inspectors.

The Guidelines also give advice on implementing a food recovery program, various 

ways to contribute to food recovery programs, choosing suitable partners, and laying 

the foundation for a successful program. This includes food safety provisions in 

alignment with the FDA Food Code, guidelines for monitoring food recovery programs, 

and handling of donations of game animals. For simple recordkeeping, the contain 

sample forms designed to facilitate the management of a variety of aspects of food 

recovery programs. 
FDA Food Code 2022 Annex 2. References

Annex 2 - 72

For in-depth information, see the available via the Conference for Food Protection web 

page at Comprehensive Guidelines for Food Recovery Programs 

http://www.foodprotect.org/guides-documents/

N. Retail Food Protection Program Information Manual: Storage and Handling of 

Tomatoes, 2007. 

This document can be found at the web site: 

http://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/IndustryandRegulat

oryAssistanceandTrainingResources/ucm113843.htm

The Retail Food Protection Program Information Manual, Storage and Handling of 

Tomatoes provides safe storage and handling practices for cut tomatoes and additional 

rationale for including cut tomatoes in the definition of time/temperature control for 

safety food in the 2005 Food Code. Historically, uncooked fruits and vegetables have 

been considered non-TCS food unless they were epidemiologically implicated in 

foodborne illness outbreaks and are capable of supporting the growth of pathogenic 

bacteria in the absence of temperature control. Since 1990, at least 12 multi-state 

foodborne illness outbreaks have been associated with different varieties of tomatoes. 

From 1998 – 2006, outbreaks associated with tomatoes made up 17% of the producerelated outbreaks reported to FDA. Salmonella has been the pathogen of concern most 

often associated with tomato outbreaks. Recommendations are being offered to prevent 

contamination in food service facilities and retail food stores and to reduce the growth of 

pathogenic bacteria when contamination of fresh tomatoes may have already occurred 

(regardless of the location where the contamination occurred).

O. Retail Food Protection Program Information Manual: Recommendations to 

Food Establishments for Serving or Selling Cut Leafy Greens.

This document can be found at:

http://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/IndustryandRegulat

oryAssistanceandTrainingResources/ucm113843.htm.

Following 24 multi-state outbreaks between 1998 and 2008, cut leafy greens was added 

to the definition of time/temperature for safety food requiring time-temperature control 

for safety (TCS). The term used in the definition includes a variety of cut lettuces and 

leafy greens. Raw agricultural commodities (RACs) that are not processed or cut on-site 

are excluded from the definition of cut leafy greens. Herbs such as cilantro or parsley 

are also not considered cut leafy greens. The pH, water activity, available moisture and 

nutrients of cut leafy greens supports the growth of foodborne pathogens and 

refrigeration at 41oF (5oC) or less inhibits growth and promotes general die off in some 

pathogens such as E. coli O157:H7. Salmonella, E. coli O157:H7 and Listeria 

monocytogenes, once attached to the surface or internalized into cut surfaces of leafy 
FDA Food Code 2022 Annex 2. References

Annex 2 - 73

greens, are only marginally affected by chemical sanitizers. Recommended handling 

instructions for leafy greens during purchasing and receiving, storage, food employee 

handling fresh produce, washing fresh produce, preparation for sale or service and 

display for sale or service are attached to the document. 

P. Employee Health and Personal Hygiene Handbook

This document can be found at: 

http://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/IndustryandRegulat

oryAssistanceandTrainingResources/ucm113827.htm. 

The Employee Health and Personal Hygiene Handbook was developed to 

encourage practices and behaviors that can help prevent food employees from 

spreading foodborne pathogens to food. Information is provided in a question-andanswer format and includes easy references to forms and tables that food service and 

retail food establishments and the public health community may find useful when 

training staff and addressing employee health and hygiene matters. This handbook 

highlights a combination of three interventions that can be effective in prevention of the 

transmission of foodborne viruses and bacteria in food establishments. These 

interventions include: (a) restricting or excluding ill food employees from working with 

food; (b) using proper handwashing procedures; and (c) eliminating bare hand contact 

with foods that are ready-to-eat (RTE). Concurrent use of each intervention will help 

prevent the transmission of viruses, bacteria and protozoan oocysts from food 

employees to consumers through contaminated food. Note that the recommendations 

provided are not to be construed as medical advice or directions to diagnose a 

medical condition. 

The person in charge and the food employee always have the option to seek 

professional medical attention as warranted by the situation at hand.

Q. Risk Assessment Process and Spreadsheet to Redesignate Food Code 

Provisions

These documents can be found at:

http://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/default.htm

FDA developed a set of definitions and a qualitative risk assessment process to 

redesignate the Food Code provisions and work with the CFP Critical Items Committee 

of stakeholders for feedback. It changed “critical” and “non-critical” to risk designations 

which include “priority item,” “ priority foundation item” and “core item” to link the 

provision to hazards associated with foodborne illness or injury. The method used is 

described in “Risk Assessment Process to Redesignate Food Code Provisions” 

and the decision-making process recorded in the Excel spreadsheet for transparency. 
FDA Food Code 2022 Annex 2. References

Annex 2 - 74

The risk assessment decision-making process explained in the instructions provides a 

science-based rationale for each redesignation. It is internally consistent and consistent 

with peer-reviewed publications.

The process considered the general and specific hazards that each provision is 

intended to address. An initial risk designation was made based on the definitions for 

“priority item,” “ priority foundation item”, and “core item”, to show how directly the 

provision eliminated, prevented or reduced to an acceptable level, the hazards

associated with foodborne illness or injury. To further refine the designation, the 

virulence or severity of the hazard in the absence of control by this Code provision was 

also examined. Contributing factors (contamination factors, proliferating/amplification 

factors, survival factors and method of preparation) identified for foodborne outbreaks 

reported to the Centers for Disease Control and Prevention were also considered. The 

risk designation was then re-evaluated in terms of meeting the definition, characteristics 

of the potential hazards, size and/or number of outbreaks caused by the hazard in 

conjunction with non-application of this Code provision and the contributing factors. The 

final determination was based on the term which most closely defined that provision, 

taking into account any weighting due to severity and infectivity of the hazard. Additional 

comments and references to explain or support this determination were included on the 

spreadsheet.

R. Parameters for Determining Inoculated Pack/Challenge Study Protocols

The National Advisory Committee on Microbiological Criteria for Foods (NACMCF), in 

response to questions posed by FDA, developed guidelines for conducting challenge 

studies on pathogen inhibition and inactivation studies in a variety of foods. The 

guidelines are available at: 

http://www.fsis.usda.gov/wps/portal/informational/aboutfsis/!ut/p/a0/04_Sj9CPykssy0xP

LMnMz0vMAfGjzOINAg3MDC2dDbz8LQ3dDDz9wgL9vZ2dDdz9TfQLsh0VAfb5Y5I!/?1

dmy¤t=true&urile=wcm%3Apath%3A%2Ffsiscontent%2Finternet%2Fmain%2Ftopics%2Fdata-collection-andreports%2Fnacmcf%2Fcurrent-subcommittees%2Fparameters-for-inoculated-packchallenge-study-protocols%2Fct_index9

The document is intended for use by the food industry, including food processors, food 

service operators and food retailers; federal, state and local food safety regulators; 

public health officials; food testing laboratories; and process authorities. The document 

is focused on, and limited to, bacterial inactivation and growth inhibition and does not 

make specific recommendations with respect to public health. NACMCF concluded that 

challenge studies should be designed considering the most current advances in 

methodologies, current thinking on pathogens of concern, and an understanding of the 

product preparation, variability and storage conditions. Studies should be completed 
FDA Food Code 2022 Annex 2. References

Annex 2 - 75

and evaluated under the guidance of an expert microbiologist in a qualified laboratory 

and should include appropriate statistical design and data analyses. 

This document provides guidelines for choice of microorganisms for studies, inoculum 

preparation, inoculum level, methods of inoculation, incubation temperatures and times, 

sampling considerations, and interpreting test results. Examples of appropriately 

designed growth inhibition and inactivation studies are provided. The NACMCF report, 

through tables and appendices, also provides sources of accepted laboratory methods, 

considerations for selecting a laboratory, pathogens of concern with control methods for 

food product categories, relevant Food Code definitions and food product checklists that 

test the protocol. 

It also includes recommended minimum expertise for designing, conducting and 

evaluating microbiological studies; potential pathogens of concern for growth studies 

based on pH and aw; examples of mathematical growth and inactivation models and 

their application to different foods; pathogen growth ranges used in CommBase and 

Pathogen Modeling Program models; and limits for growth when other conditions are 

near optimum.

S. The Council to Improve Foodborne Outbreak Response (CIFOR) – Guidelines 

for Foodborne Outbreak Response

This document can be found at: http://www.cifor.us/CIFORGuidelinesProjectMore.cfm

The Guidelines for Foodborne Outbreak Response describe the overall approach to 

foodborne disease outbreaks, including preparation, detection, investigation, control and 

follow-up. The Guidelines also describe the roles of all key organizations in foodborne 

disease outbreaks. The Guidelines are targeted at local, state and federal agencies that 

are responsible for preventing and managing foodborne disease.

T. CIFOR Foodborne Illness Response Guidelines for Owners, Operators, and 

Managers of Food Establishments (CIFOR Industry Guidelines)

In 2009, the Council to Improve Foodborne Outbreak Response (CIFOR) convened a 

workgroup comprised of representatives from the food industry and local, state and 

Federal government for the purpose of creating guidelines and tools specific 

for industry response to foodborne illness. The resulting document, called the CIFOR 

Foodborne Illness Response Guidelines for Owners, Operators, and Managers of Food 

Establishments (CIFOR Industry Guidelines), was developed as voluntary guidance for 

managers of Food Establishments (“Industry”) to help outline, clarify, and explain 

Industry’s recommended role in a foodborne illness outbreak investigation. These 

CIFOR Industry Guidelines:

• Provide a step-by-step approach including Preparation, Illness Complaints, 

Investigation, Control, and Follow-up 
FDA Food Code 2022 Annex 2. References

Annex 2 - 76

• Describe what to expect when first notified of potential illnesses or outbreak

• Provide Tools to guide Industry through the regulatory investigation process.

This document is available for download at: http://www.cifor.us/index.cfm

U. Sanitation Practices Standard Operating Procedures and Good Retail Practices 

to Minimize Contamination and Growth of Listeria Monocytogenes with Food 

Establishments, 2nd Edition.

The “Sanitation Practices Standard Operating Procedures and Good Retail Practices to 

Minimize Contamination and Growth of Listeria Monocytogenes with Food 

Establishments, 2nd Edition” replaces a 2006 document by the Conference for 

FoodProtection (CFP). The new voluntary guidelines address recommended standard 

operating procedures (SOPs) and good retail practices (GRPs) to minimize 

contamination and growth of Listeria Monocytogenes in retail food establishments.

This document is available for download at: 

http://www.foodprotect.org/media/site/january-2016-cfp-lm-document-v3.pdf

V. The Bad Bug Book, 2nd Edition Foodborne Pathogenic Microorganisms and 

Natural Toxins Handbook.

The Bad Bug Book 2nd Edition provides current information about the major known 

agents that cause foodborne illness. Each chapter is about a pathogen—a bacterium, 

virus, or parasite—or a natural toxin that can contaminate food and cause illness. The 

book contains scientific and technical information about the major pathogens that cause 

these kinds of illnesses.

The Bad Bug Book is published by the Center for Food Safety and Applied Nutrition 

(CFSAN) of the Food and Drug Administration (FDA), U.S. Department of Health and 

Human Services.

This document is available for download at: 

https://www.fda.gov/downloads/Food/FoodborneIllnessContaminants/UCM297627.pdf

W. Minimizing the Risk of Campylobactor and Salmonella Illnesses Associated 

with Chicken Liver

USDA-FSIS has found that from 2000 to 2015, chicken livers were associated with 22 

outbreaks most commonly due to undercooking. USDA-FSIS’ Compliance Guideline, 

Minimizing the Risk of Campylobacter and Salmonella Illnesses Associated with 

Chicken Liver provides additional guidance that retailers and others can use to reduce 

or eliminate pathogens, thereby decreasing the likelihood of foodborne illness outbreaks 

from this product. The guidance document explains why searing the outside of the liver 

is not adequate for pathogen elimination in chicken livers and emphasizes appropriate 

cooking to an internal temperature of 165°F to avoid illnesses. Thorough cooking is the 
FDA Food Code 2022 Annex 2. References

Annex 2 - 77

only method to eliminate pathogens. This guidance also provides other 

recommendations to minimize (but not eliminate) pathogen contamination associated 

with undercooked chicken liver dishes.

This document is available for download at:

https://www.fsis.usda.gov/wps/wcm/connect/b3f4efe7-27d4-4c39-bce7-

011b7bbd1e7d/Chicken-Liver-Guidance-July-2018.pdf?MOD=AJPERES

X. Guidance Document for Direct to Consumer and Third-Party Delivery Service 

Food Delivery 

Companies that engage in direct-to-consumer and third-party delivery service food 

delivery have increased in recent years. In 2018 the Conference for Food Protection 

recommended formation of a committee to revise the existing guidance for direct-toconsumer (mail order) food companies to include guidance for companies engaging in 

third-party delivery serviced for food delivery. This guidance document provides food 

safety best practices for managing or performing Direct to Consumer (DTC) or thirdparty delivery (TPD) services.

This document is available for download at:

http://www.foodprotect.org/media/guide/guidance-document-for-direct-to-consumer-andthird-party-delivery.pdf 

Y. Whole Roaster Pigs: Guidance for the Safe Handling and Cooking 

This document can be found at: http://www.foodprotect.org/guides-documents/wholeroaster-pigs-guidance-for-the-safe-handling-and-cooking/

Roaster pigs present unique challenges for handling and cooking due to their variable, 

and sometimes, large size. This guidance document provides practical 

recommendations for the safe handling, preparation, and cooking of roaster pigs. It 

contains a synopsis on lessons learned from previous outbreaks and a discussion on 

common handling and cooking practices of roaster pigs including a description of the 

food safety risks associated with certain practices and practical recommendations to 

mitigate the food safety risk. 

Z. National Shellfish Sanitation Program (NSSP) Guide for the Control of 

Molluscan Shellfish

Food and Drug Administration, Center for Food Safety and Applied Nutrition, 2019. 

National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish, can 

be found at: https://www.fda.gov/food/federalstate-food-programs/national-shellfishsanitation-programnssp#:~:text=The%20National%20Shellfish%20Sanitation%20Program,and%20sold%2

0for%20human%20consumption.
FDA Food Code 2022 Annex 2. References

Annex 2 - 78

The National Shellfish Sanitation Program (NSSP) is the federal/state cooperative 

program recognized by the U. S. Food and Drug Administration (FDA) and the Interstate 

Shellfish Sanitation Conference (ISSC) for the sanitary control of shellfish produced and 

sold for human consumption. The purpose of the NSSP is to promote and improve the 

sanitation of shellfish (oysters, clams, mussels and scallops) moving in interstate 

commerce through federal/state cooperation and uniformity of State shellfish programs. 

Participants in the NSSP include agencies from shellfish producing and non-producing 

States, FDA, EPA, NOAA, and the shellfish industry. Under international agreements 

with FDA, foreign governments also participate in the NSSP. Other components of the 

NSSP include program guidelines, State growing area classification and dealer 

certification programs, and FDA evaluation of State program elements.

The NSSP Guide for the Control of Molluscan Shellfish 

https://www.fda.gov/media/143238/download consists of a Model Ordinance, supporting 

guidance documents, recommended forms, and other related materials associated with 

the Program. The Model Ordinance includes guidelines to ensure that the shellfish 

produced in States in compliance with the guidelines are safe and sanitary. The Model 

Ordinance provides readily adoptable standards and administrative practices necessary 

for the sanitary control of molluscan shellfish. The Model Ordinance is intended to cover 

molluscan shellfish that are raw (live, fresh or fresh frozen) and molluscan shellfish 

subjected to post-harvest processing (PHP) as defined in this Guide. Cooked shellfish, 

shellfish subject to 21 CFR part 113 or 114, or raw shellfish packaged with the explicit 

intent that they will be cooked by the end consumer (such as breaded or marinated) are 

generally recognized as products that are beyond the scope of the NSSP and are 

subject to the Seafood HACCP regulations (21 CFR 123). However, such shellfish 

products intended for interstate commerce are still subject to the appropriate harvest 

and/or approved source controls outlined in this Guide when they are necessary to 

control a food safety hazard.

4. Food Defense Guidance from Farm to Table

The following is a summary of available resources on food defense that is of interest to 

the retail and food service food community. This listing is provided below and is not allinclusive. It contains links to publications from federal regulatory agencies (primarily 

FDA, CDC, and USDA) and industry groups with information of interest to regulators, 

industry, and consumers. Responsibility for updating the web pages lies with the listed 

organization and those listed are up-to-date as of the printing of the 2005 Food Code. 

FDA Publications:

These guidance documents identify the kinds of preventive measures that food 

establishment and food processing operators may take to minimize risks to food under 

their control, from tampering or other malicious, criminal, or terrorist actions: 

• Retail Food Stores and Food Service Establishments: Food Security 

Preventive Measures Guidance at 
FDA Food Code 2022 Annex 2. References

Annex 2 - 79

http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInf

ormation/FoodDefense/ucm082751.htm 

• Food Producers, Processors, and Transporters: Food Security Preventive 

Measures Guidance at 

http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInf

ormation/FoodDefense/ucm083075.htm 

• Dairy Farms, Bulk Milk Transporters, Bulk Milk Transfer Stations and Fluid Milk 

Processors Food Security Preventive Measures Guidance at 

http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulat

oryInformation/FoodDefense/ucm083049.htm 

• Importers and Filers: Food Security Preventive Measures Guidance at 

http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInf

ormation/FoodDefense/ucm078978.htm

• The Bioterrorism Act of 2002 at: 

http://www.fda.gov/RegulatoryInformation/Legislation/ucm148797.htm 

USDA Publications: 

• Food Safety and Inspection Service (FSIS) Security Guidelines for Food 

Processors at https://www.fsis.usda.gov/wps/wcm/connect/457116c6-dccb494a-a419-62d07d4123a4/PHVv2Homeland_Food_SecuritySecurity_Guide.pdf?MOD=AJPERES at 

https://www.fsis.usda.gov/wps/portal/fsis/topics/food-defense-and-emergencyresponse/preparation-and-prevention/guidance-documents/securityguidelines/keep-americas-food-safe

This guidance is designed to assist transporters, warehouses, distributors, 

retailers, and restaurants with enhancing their security programs to further 

protect the food supply from contamination due to criminal or terrorist acts at: 

https://www.fsis.usda.gov/shared/PDF/Transportation_Security_Guidelines.pdf. 

This guidance contains recommendations to ensure the security of food products 

through all phases of the distribution process. 

Additional information on FSIS food security guidance publications is available 

over the Internet at http://www.fsis.usda.gov. 

Industry Publications: 

• National Restaurant Association Information for restaurants can be found at 

http://www.restaurant.org. 

• Food Marketing Institute (FMI) Security Information and Resources web page 

at http://www.fmi.org/foodsafety/ provides access to security information and 

guidelines targeted specifically to food retailers. 
FDA Food Code 2022 Annex 2. References

Annex 2 - 80

Guidance on Responding to Food Emergencies: 

Centers for Disease Control and Prevention (CDC) Emergency Preparedness and 

Response information can be found at https://www.cdc.gov/nceh/ehs/etp/food.htm. 

• USDA – Food and Nutrition Service food emergency publication Responding 

to a Food Recall at https://www.fns.usda.gov/responding-food-recallprocedures-recalls-usda-foods

• FDA’s Office of Emergency Operations at 301-443-1240 for FDA regulated 

products and FSIS Technical Service Center at 1-800-233-3935 for USDA 

regulated products.

• Conference for Food Protection (CFP) Emergency Action Plan for Retail Food 

Establishments, 2nd Editon can be found at http://www.foodprotect.org/.

Food Defense and Emergency Guidance of Interest to Schools: 

• A Biosecurity Checklist for School Foodservice: Developing a Biosecurity 

Management Plan 

The document is from the USDA – Food and Nutrition Service and provides 

information for school food service managers. It can be found at 

https://dese.mo.gov/sites/default/files/BiosecurityRevisedChecklist.pdf. The exact 

link to the checklist is http://foodbiosecurity.nfsmi.org/FSManager.php.

• USDA – Food and Nutrition Service food emergency publication, Emergency 

Readiness Plan: A Guide for the School Foodservice Operation at

http://www.nfsmi.org/documentlibraryfiles/PDF/20080207044955.pdf

Defense Guidance of Interest to Consumers: 

• Food Safety and Security: What Consumers Need to Know, at 

http://www.fsis.usda.gov/wps/portal/fsis/topics/food-safety-education/getanswers/food-safety-fact-sheets/emergency-preparedness/food-safety-andsecurity-what-consumers-need-to-know

• Food Tampering: An Extra Ounce of Caution, at 

http://www.fda.gov/Food/ResourcesForYou/Consumers/ucm079137.htm
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 1 

Annex 3 Public Health 

Reasons/Administrative 

Guidelines 

Parts: 

Chapter 1. Purpose and Definitions

Chapter 2. Management and Personnel

Chapter 3. Food

Chapter 4. Equipment, Utensils, and Linens

Chapter 5. Water, Plumbing, and Waste

Chapter 6. Physical Facilities

Chapter 7. Poisonous or Toxic Materials

Chapter 8. Compliance and Enforcement

Chapter 1. Purpose and Definitions

Applicability and terms defined

1-201.10 Statement of Application and Listing of Terms.

(B) Terms Defined

The individual definitions in Chapter 1 are not numbered, consistent with current 

conventions regarding the use of plain language in drafting rules, and with use in 

national and international standards and some Federal regulations. This facilitates 

making changes to the definitions as they become necessary in subsequent editions of 

the Food Code. The intent of the definitions to be binding in terms of the application and 

interpretation of the Code is clearly stated in Chapter 1. 
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 2

Accredited Program.

Refer to the definition for Accredited Program in ¶1-201.10 (B)(3).

Food protection manager certification occurs when individuals demonstrate through a 

certification program that they have met specified food safety knowledge standards.

Food protection certification program accreditation occurs when certification 

organizations demonstrate through an accreditation program that they have met 

specified program standards.

Accreditation is a conformity assessment process through which organizations that 

certify individuals may voluntarily seek independent evaluation and listing by an 

accrediting agency based upon the certifying organization=s meeting program 

accreditation standards. Such accreditation standards typically relate to such factors as 

the certifying organization's structure, mission, policies, procedures, and the 

defensibility of its examination processes. These standards are intended to affirm or 

enhance the quality and credibility of the certification process, minimize the potential for 

conflicts of interest, ensure fairness to candidates for certification and others, and 

thereby increase public health protection.

Program accreditation standards known to be relevant to food protection manager 

certification programs include those contained in the Standards for Accreditation of 

Food Protection Manager Certification Programs available from the Conference for 

Food Protection, 2792 Miramar Lane, Lincoln, CA 95648 and found at 

http://www.foodprotect.org/

Allowing food protection managers to demonstrate their required food safety knowledge 

"through passing a test that is part of an accredited program" is predicated on the fact 

that their credentials have been issued by certifying organizations that have 

demonstrated conformance with rigorous and nationally recognized program standards. 
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 3

Certification Number.

A list of certification number designations was added to the definition for clarity.

 

 Table A. Certifications

ACRONYM TERM

SP Shucker Packer

RP Repacker

SS SHELLSTOCK Shipper

RS Reshipper

DP Depuration

Table B. Permits

ACRONYM TERM

PHP Post-Harvest Processing

AQ Aquaculture

WS Wet Storage

This list includes a type of certification newly listed in the Food Code which may be 

unfamiliar to retailers – Depuration (DP). Depuration or Depurate means the process of 

reducing the pathogenic organisms that may be present in shellstock by using a 

controlled aquatic environment as the treatment process.

Egg.

The definition of egg includes avian species’ shell eggs known to be commercially 

marketed in the United States. Also included are the eggs of quail and ratites such as 

ostrich. 

Not included are baluts. Baluts are considered a delicacy among Philippine and 

Vietnamese populations. They are derived from fertile eggs, typically duck eggs, 

subjected to incubation temperatures for a period of time less than necessary for the 

embryo to hatch resulting in a partially formed embryo within the shell. Under the Egg 

Products Inspection Act (EPIA), an egg is typically considered adulterated if it has been 

subjected to incubation. However, in 9 CFR 590.5, baluts are specifically exempted 

from inspection as eggs under the EPIA. 

In producing baluts, fertile duck eggs are incubated for approximately 18 days at a 

temperature of 42.5°C (108.5°F) in incubators with a relatively high humidity. (Complete 

development and hatching would take place in 28 days.) Under these conditions, the 

potential for growth of transovarian Salmonella organisms such as S. Enteritidis within 

the shell, and the potential for an increase in pathogenic microflora on the shell itself, 

are increased. Where chicken eggs are used in preparing baluts, the incubation period 

may only be 14 days at an incubation temperature of 37°C (99°F). A balut is a 

time/temperature control for safety food subject to time/temperature management
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 4

including proper cooking and hot and cold holding. Baluts are typically boiled and 

packed in salt before sale or service. 

Also, not included in this definition are the eggs of reptile species such as alligators and 

turtles. Alligator eggs are available for sale in some parts of the southern United States. 

In restaurants, the menu item “Alligator Eggs” is sometimes made of alligator egg, but 

other times is simply a fanciful name for a menu item that may include seafood items 

such as shrimp, but contains no alligator egg. 

Sea turtle eggs have been consumed in Asian and Latin American Countries. However, 

turtle eggs are not mentioned in the definitions section because sea turtles 

(Loggerhead, East Pacific Green, Leatherback, Hawksbill, Kemp’s Ridley, and Olive 

Ridley) are protected by The Endangered Species Act of 1973 and therefore may not be 

sold or consumed. This Act, with respect to turtle eggs, is enforced by the United States 

Department of Interior, U.S. Fish and Wildlife Service, Washington, DC. 

Food establishment and food processing plant.

Food establishment and a food processing plant located within the same 

premises of a food establishment:

Some food businesses perform operations that provide food directly to consumers as a

“Food Establishment,” and also supply food to other business entities as a “Food

Processing Plant.” Within such a business, those operations that provide food directly to 

consumers only should be considered part of a “Food Establishment” for the purposes 

of applying the Food Code while those operations that supply food to other business 

entities may be subject to other rules and regulations that apply to “Food Processing 

Plants”. It is essential that the permit holder and persons in charge be aware that 

regulatory requirements and the appropriate operational practices for “Food 

Establishments” may differ from those for “Food Processing Plants.”

Some facilities and functions may be subject to different regulatory requirements 

depending on whether that facility or function is regulated as a “Food Establishment” or 

as a “Food Processing Plant”, or both. Those facilities and functions within a business 

that are shared by both the “Food Establishment” and “Food Processing Plant” 

operations, e.g., refrigeration units, dressing room and toilet facilities, food equipment, 

water and waste systems, pest control, might be subject to similar regulatory 

requirements. The Food Code is intended to apply to “food establishments”.

In-Shell Product.

In-shell product was added as a defined term, as this category of product is available 

for sale, has unique characteristics, and must be handled safely within the retail 

environment. In-shell product is a non-viable (dead) molluscan shellfish product with 

one or both shells attached. Common products that retailers may encounter include but 

are not limited to individually quick frozen (IQF) oysters, whole frozen shellstock, 

banded high pressure treated oysters, and irradiated oysters. These products may or 

may not be treated to limit pathogens such as vibrio sp. Parameters for safe sourcing, 
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 5

receiving, containers, labeling, and records can be found in subparts 3-201, 3-202, and 

3-203 of this Code.

Packaged.

The definition of “packaged” was revised in (2) to clarify when foods packaged at retail 

need not be labeled. 

Refer to Public Health Reasons for Food Labels §3-602.11. 

Time/Temperature Control for Safety Food.

Time Temperature Control for Safety Food (TCS) is defined in terms of whether or not it 

requires time/temperature control for safety to limit pathogen growth or toxin formation. 

The term does not include foods that do not support growth but may contain a 

pathogenic microorganism or chemical or physical food safety hazard at a level 

sufficient to cause foodborne illness or injury. The progressive growth of all foodborne 

pathogens is considered whether slow or rapid. 

The definition of TCS food takes into consideration pH, aw, pH and aw interaction, heat 

treatment, and packaging for a relatively simple determination of whether the food 

requires time/temperature control for safety. If the food is heat-treated to eliminate 

vegetative cells, it needs to be addressed differently than a raw product with no, or 

inadequate, heat treatment. In addition, if the food is packaged after heat treatment to 

destroy vegetative cells and subsequently packaged to prevent re-contamination, higher 

ranges of pH and/or aw can be tolerated because remaining spore-forming bacteria are 

the only microbial hazards of concern. While foods will need to be cooled slightly to 

prevent condensation inside the package, they must be protected from contamination in 

an area with limited access and packaged before temperatures drop below 57°C 

(135°F). In some foods, it is possible that neither the pH value nor the aw value is low 

enough by itself to control or eliminate pathogen growth; however, the interaction of pH 

and aw may be able to accomplish it. This is an example of a hurdle technology. Hurdle 

technology involves several inhibitory factors being used together to control or eliminate 

pathogen growth, when they would otherwise be ineffective if used alone. When no 

other inhibitory factors are present and the pH and/or aw values are unable to control or 

eliminate bacterial pathogens which may be present, growth may occur and foodborne 

outbreaks result. Cut melons, cut tomatoes, and cut leafy greens are examples where 

intrinsic factors are unable to control bacterial growth once pathogens are exposed to 

the cellular fluids and nutrients after cutting.

In determining if time/temperature control is required, combination products present 

their own challenge. A combination product is one in which there are two or more 

distinct food components and an interface between the two components may have a 

different property than either of the individual components. A determination must be 

made about whether the food has distinct components such as pie with meringue 

topping, focaccia bread, meat salads, or fettuccine alfredo with chicken or whether it 

has a uniform consistency such as gravies, puddings, or sauces. In these products, the 

pH at the interface is important in determining if the item is a TCS food. 
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 6

A well designed inoculation study or other published scientific research should be used 

to determine whether a food can be held without time/temperature control when: 

• Process technologies other than heat are applied to destroy foodborne 

pathogens (e.g., irradiation, high pressure processing, pulsed light, 

ozonation); 

• Combination products are prepared; or

• Other extrinsic factors (e.g., packaging/atmospheres) or intrinsic factors 

(e.g., redox potential, salt content, antimicrobials) are used to control or 

eliminate pathogen growth. 

Before using Tables A and B in paragraph 1-201.10(B) of the definition for 

“time/temperature control for safety food” in determining whether a food requires 

time/temperature control for safety (TCS), answers to the following questions should be 

considered:

o Is the intent to hold the food without using time or temperature control? 

 If the answer is No, no further action is required. The decision tree 

later in this Annex is not needed to determine if the item is a TCS 

food. 

o Is the food raw, or is the food heat-treated? 

o Does the food already require time/temperature control for safety by 

definition in paragraph 1-201.10(B)? 

o Does a product history with sound scientific rationale exist indicating a 

safe history of use? 

o Is the food processed and packaged so that it no longer requires TCS 

such as ultra high temperature (UHT) creamers or shelf-stable canned 

goods? 

o What is the pH and aw of the food in question using an independent 

laboratory and Association of Official Analytical Chemists (AOAC) 

methods of analysis? 

A food designated as product assessment (PA) required, in either table should be 

considered TCS Food until further study proves otherwise. The PA means that based 

on the food’s pH and aw and whether it was raw or heat-treated or packaged, it has to 

be considered TCS until inoculation studies or some other acceptable evidence shows 

that the food is a TCS food or not. The Food Code requires a variance request to the 

regulatory authority with the evidence that the food does not require time/temperature 

control for safety. 

When a "Product Assessment" is indicated in Table A or Table B, a challenge study 

may be done to determine the shelf life of the product, or the time a product can be 

maintained at ambient temperature. Documents have been developed through the 

Conference for Food Protection (CFP) Product Assessment Committee to assist 

operators and regulators with the National Advisory Committee on Microbiological 

Criteria for Foods (NACMCF) Parameters for Determining Inoculated Pack/Challenge 

Study Protocols. These documents include Guidance Document on Using NACMCF 
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 7

Parameters for Challenge Study Protocols for Retail Food Operators and Regulators, 

Checklist for Retail Establishment Challenge Study, and Challenge Testing Worksheet 

to Determine Microbiological Stability of Formulation. These documents can be found 

on the CFP website http://www.foodprotect.org/guides-documents/using-nacmcfparameters-for-challenge-study-protocols-for-retail-food-operators-and-regulators/

The Food Code definition designates certain raw plant foods as TCS food because they 

have been shown to support the growth of foodborne pathogens in the absence of 

temperature control and to lack intrinsic factors that would inhibit pathogen growth. 

Unless product assessment shows otherwise, these designations are supported by 

Tables A and B. For example: 

For cut cantaloupe (pH 6.2-7.1, aw > 0.99, not heat-treated),. fresh sprouts (pH > 6.5, aw 

> 0.99, not heat-treated), and cut tomatoes (pH 4.23 – 5.04, aw > 0.99, not heat-treated), 

Table B indicates that they are considered TCS Foods unless a product assessment 

shows otherwise. Maintaining these products under the temperature control 

requirements prescribed in this code for TCS food will limit the growth of pathogens that 

may be present in or on the food and may help prevent foodborne illness.

If a facility adjusts the pH of a food using vinegar, lemon juice, or citric acid for purposes 

other than flavor enhancement, a variance is required under ¶ 3-502.11(C). A HACCP 

plan is required whether the food is a TCS food as in subparagraph 3-502.11 (C)(1) or 

not a TCS food, as in subparagraph 3-502.11(C)(2). A standardized recipe validated by 

lab testing for pH and aw would be an appropriate part of the variance request with 

annual (or other frequency as specified by the regulatory authority) samples tested to 

verify compliance with the conditions of the variance. 

More information can be found in the Institute of Food Technologists (IFT) Report, 

“Evaluation and Definition of Potentially Hazardous Foods” at

http://www.fda.gov/Food/FoodScienceResearch/SafePracticesforFoodProcesses/ucm0

94141.htm
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 8

Instructions for using the following Decision Tree and Table A and Table B:

1. Does the operator want to hold the food without using time or temperature 

control? 

a. No – Continue holding the food at ≤5°C(41°F) or ≥57°C(135°F) for 

safety and/or quality. 

b. Yes – Continue using the decision tree to identify which table to use to 

determine whether time/temperature control for safety (TCS) is 

required. 

2. Is the food heat-treated? 

a. No – The food is either raw, partially cooked (not cooked to the 

temperature specified in section 3-401.11 of the Food Code) or treated 

with some other method other than heat. Proceed to step #3. 

b. Yes – If the food is heat-treated to the required temperature for that 

food as specified under section 3-401.11 of the Food Code, vegetative 

cells will be destroyed although spores will survive. Proceed to step #4. 

3. Is the food treated using some other method? 

a. No –The food is raw or has only received a partial cook allowing 

vegetative cells and spores to survive. Proceed to step #6. 

b. Yes – If a method other than heat is used to destroy pathogens such 

as irradiation, high pressure processing, pulsed light, ultrasound, 

inductive heating, or ozonation, the effectiveness of the process needs 

to be validated by inoculation studies or other means. Proceed to step 

#5. 

4. Is it packaged to prevent re-contamination? 

a. No – Re-contamination of the product can occur after heat treatment 

because it is not packaged. Proceed to step #6. 

b. Yes – If the food is packaged immediately after heat treatment to 

prevent re-contamination, higher ranges of pH and/or aw can be 

tolerated because spore-forming bacteria are the only microbial 

hazard. Proceed to step #7. 

5. Further product assessment or vendor documentation required. 

a. The vendor of this product may be able to supply documentation that 

inoculation studies indicate the food can be safely held without 

time/temperature control for safety. 

b. Food prepared or processed using new technologies may be held 

without time/temperature control provided the effectiveness of the use 

of such technologies is based on a validated inoculation study. 
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 9

6. Using the food’s known pH and/or aw values, position the food in the appropriate 

table. 

a. Choose the column under “pH values” that contains the pH value of the 

food in question. 

b. Choose the row under “aw values” that contains the aw value of the 

food in question. 

c. Note where the row and column intersect to identify whether the food is 

“non-TCS food” and therefore does not require time/temperature 

control, or whether further product assessment (PA) is required. Other 

factors such as redox potential, competitive microorganisms, salt 

content, or processing methods may allow the product to be held 

without time/temperature control but an inoculation study is required. 

7. Use Table A for foods that are heat-treated and packaged OR use Table B for 

foods that are not heat-treated or heat-treated but not packaged. 

8. Determine if the item is non-TCS or needs further product assessment (PA). 
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 10

1-201.10(B) Decision Tree #1 – Using pH, aw, or the Interaction 

of pH and aw to Determine if a Food Requires Time/Temperature 

Control for Safety
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 11

1-201.10(B) – Table A and Table B

Table A. Interaction of PH and AW for control of spores in FOOD heat-treated

to destroy vegetative cells and subsequently PACKAGED

AW VALUES PH: 4.6 OR LESS PH: > 4.6 - 5.6 PH: > 5.6

≤ 0.92 non-TCS food* non-TCS food non-TCS food

> 0.92 - 0.95 non-TCS food non-TCS food PA**

> 0.95 non-TCS food PA PA

* TCS food means Time/Temperature Control for Safety food

** PA means Product Assessment required

Table B. Interaction of PH and AW for control of vegetative cells and spores

in FOOD not heat-treated or heat-treated but not PACKAGED

AW VALUES PH: < 4.2 PH: 4.2 - 4.6 PH: > 4.6 - 5.0 PH: > 5.0

< 0.88 non-TCS food* non-TCS food non-TCS food non-TCS food

0.88 – 0.90 non-TCS food non-TCS food non-TCS food PA**

> 0.90 – 0.92 non-TCS food non-TCS food PA PA

> 0.92 Non-TCS food PA PA PA

Tobacco Product.

“Tobacco product” has the meaning stated in the Federal Food, Drug and Cosmetic Act 

§ 201(rr).

(rr)(1) The term "tobacco product" means any product made or derived from tobacco, 

or containing nicotine from any source, that is intended for human consumption, 

including any component, part, or accessory of a tobacco product (except for raw 

materials other than tobacco used in manufacturing a component, part, or accessory of 

a tobacco product).

(2) The term "tobacco product" does not mean an article that is a drug under 

subsection (g)(1), a device under subsection (h), or a combination product described 

in section 353(g) of this title.

(3) The products described in paragraph (2) shall be subject to subchapter V of this 

chapter.
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Annex 3 - 12

(4) A tobacco product shall not be marketed in combination with any other article or 

product regulated under this chapter (including a drug, biologic, food, cosmetic, medical 

device, or a dietary supplement).

(5) The term "tobacco product" does not mean an article that is a food under 

paragraph (f), if such article contains no nicotine, or no more than trace amounts of 

naturally occurring nicotine.

Tobacco products include, among other products, Electronic Nicotine Delivery System 

(ENDS) products, such as vapes, vaporizers, vape pens, hookah pens, electronic 

cigarettes (e-cigarettes or e-cigs), e-cigars and e-pipes; cigarettes; cigarette tobacco

products; roll-your-own tobacco products; smokeless tobacco products; cigars; pipe 

tobacco products; waterpipe tobacco products; and heated tobacco products. Note that 

this is not an exhaustive list of tobacco products. 
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Annex 3 - 13

Chapter 2. Management and Personnel

Responsibility

2-101.11 Assignment.

Designation of a person in charge during all hours of operations ensures the continuous 

presence of someone who is responsible for monitoring and managing all food 

establishment operations and who is authorized to take actions to ensure that the 

Code's objectives are fulfilled. During the day-to-day operation of a food establishment, 

a person who is immediately available and knowledgeable in both operational and Code 

requirements is needed to respond to questions and concerns and to resolve problems.

In cases where a food establishment has several departments on the premises (e.g., a 

grocery store with deli, seafood, and produce departments) and the regulatory authority 

has permitted those departments individually as separate food establishments, it may 

be unnecessary from a food safety standpoint to staff each department with a separate 

Person in Charge during periods when food is not being prepared, packaged or served. 

While activities such as moving food products from a refrigerated display case to the 

walk-in refrigerator, cleaning the floors, or doing inventory when the department is not 

busy, do take place during these times, a designated Person in Charge for multiple 

departments or the entire facility can oversee these operations and be ready to take 

corrective actions if necessary. 

The concept of an unmanned food establishment that is typically located in an office 

building or restricted break area is a recent innovation. While a wide variety of food 

items may be provided, these operations are intended to offer packaged TCS and nonTCS food products that are displayed via refrigeration units, food racks, baskets and/or 

countertop display units. There are a number of state and local agencies that mandate 

the permit holder be the person in charge or designate a person in charge present at 

the food establishment during all hours of operation. It is appropriate for State and local 

agencies, by way of codes and ordinances or by policy to establish criteria for what 

types of permitted establishments could be exempt from designating a person in charge 

present at all times during operation. Factors to consider when establishing such criteria 

include:

• Types of food served or offered

• Public access to the food establishment

• Cleaning frequency of equipment and food contact surfaces

• Surveillance operations

• Types of cold and hot holding equipment

• Contact information for management personnel of the food establishment

Regulatory Agencies are encouraged to review guidance issued thru the Conference for 

Food Protection (CFP) that addresses unmanned food establishments. The CFP posted 

Unattended Food Establishment Guidance Document can be found at the following link: 

(http://www.foodprotect.org/media/site/guidance-document-for-unattended-foodestablishments.pdf) 
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Knowledge

2-102.11 Demonstration. 

The designated person in charge who is knowledgeable about foodborne disease 

prevention, Hazard Analysis and Critical Control Point (HACCP) principles, and Code 

requirements is prepared to recognize conditions that may contribute to foodborne 

illness or that otherwise fail to comply with Code requirements, and to take appropriate 

preventive and corrective actions. 

There are many ways in which the person in charge can demonstrate competency. 

Many aspects of the food operation itself will reflect the competency of that person. A 

dialogue with the person in charge during the inspection process will also reveal 

whether or not that person is enabled by a clear understanding of the Code and its 

public health principles to follow sound food safety practices and to produce foods that 

are safe, wholesome, unadulterated, and accurately represented. 

The Food Code does not require reporting of uninfected cuts or reporting of covered, 

protected infected cuts/lesions/boils since no bare hand contact with ready-to-eat (RTE) 

food is a Code requirement.

2-102.12 Certified Food Protection Manager

The increasing complexity of the food industry, the improved ability to identify/trace 

foodborne outbreaks and other economic, staffing, cultural and behavioral challenges 

make it imperative that food protection managers know and control the risk factors that 

impact the safety of the food they sell or serve. Food protection managers have an 

important role in formulating policies, verifying food employees carry out these policies, 

and communicating with these same employees to give information about 

recommended practices to reduce the risk of foodborne illness. A Centers for Disease 

Control and Prevention Environmental Health Specialist-Network (EHS-Net) study 

suggests that the presence of a certified food protection manager reduces the risk for a 

foodborne outbreak for an establishment and was a distinguishing factor between 

restaurants that experienced a foodborne illness outbreak and those that had not. 

FDA's Retail Food Risk Factor Studies suggest that the presence of a certified manager 

has a positive correlation with more effective control of certain risk factors, such as poor 

personal hygiene, in different facility types. 

There are a number of state and local agencies that currently mandate food protection 

manager certification. It is appropriate for State and local agencies, by way of codes 

and ordinances or by policy to establish criteria for what types of permitted 

establishments could be exempt from the mandatory manager certification requirement 

and for determining the conditions under which the minimum number of certified food 

protection managers must be some number greater than one. 

Factors to consider when establishing such criteria include:

• The size and scope of the operation;
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Annex 3 - 15

• The hours of operation;, 

• The types of foods sold or served; 

• The extent to which food is prepared on site;

• The number of staff, 

• Type of population served, e.g. highly susceptible or not; and 

• The number of meals served. 

2-102.20 Food Protection Manager Certification. 

Many food protection manager certification programs have shared a desire to have the 

food manager certificates they issue universally recognized and accepted by others –

especially by the increasing number of regulatory authorities that require food manager 

certification. 

Needed has been a mechanism for regulatory authorities to use in determining which 

certificates should be considered credible based on which certificate issuing programs 

meet sound organizational and certification procedures and use defensible processes in 

their test development and administration. 

After a multi-year effort involving a diversity of stakeholder groups, the Conference for 

Food Protection (CFP) completed work on its Standards for Accreditation of Food 

Protection Manager Certification Programs found at: 

http://www.foodprotect.org/food-protection-manager-certification/. In 2002 the 

Conference entered into a cooperative agreement with the American National 

Standards Institute (ANSI) to provide independent third-party evaluation and 

accreditation of certification bodies determined to be in conformance with these 

Conference standards. ANSI published its first listing of accredited certifiers in 2003. 

The Acting Commissioner of the Food and Drug Administration, in his address before 

the 2004 biennial meeting of the Conference for Food Protection, commended this 

Conference achievement and encouraged universal acceptance based on the 

CFP/ANSI accreditation program. 

Distributed at this meeting was the following letter addressed to the Conference Chair 

and signed by the Director of FDA’s Center for Food Safety and Applied Nutrition. The 

letter puts forth the Agency’s basis for its support of universal acceptance of food 

protection manager certifications. 

“The 2004 biennial meeting of the Conference for Food Protection is a 

fitting occasion for FDA’s Center for Food Safety and Applied Nutrition to 

commend the Conference for its significant achievements in support of 

State and local food safety programs. 

The FDA in a Memorandum of Understanding recognizes the Conference 

for Food Protection as a voluntary national organization qualified to 

develop standards to promote food protection. Conference 
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Annex 3 - 16

recommendations contribute to improvements in the model FDA Food 

Code and help jurisdictions justify, adopt and implement its provisions. 

Conference mechanisms involving active participation by representatives 

of diverse stakeholder groups produce consensus standards of the 

highest quality. An excellent example is the Conference’s Standards for 

Accreditation of Food Protection Manager Certification Programs, 

and its announcement of the new on-line listing of accredited certifiers of 

industry food protection managers. Many years in their development, 

these Conference standards identify the essential components necessary 

for a credible certification program. Components cover a wide range of 

requirements such as detailed criteria for exam development and 

administration, and responsibilities of the certification organization to 

candidates and the public.

FDA applauds the Conference for this significant achievement, and 

encourages agencies at all levels of government to accept certificates 

issued by listed certifiers as meeting their jurisdictions’ food safety 

knowledge and certification requirements. The American National 

Standards Institute (ANSI) has independently evaluated these certification 

programs under an agreement with the Conference for Food Protection. 

Governments and industry widely recognize and respect ANSI as an 

accrediting organization. ANSI has found certifiers it lists as accredited 

(http://www.ansi.org/) under “conformity assessment” – “personnel 

certification accreditation” to conform to the Conference’s Standards for 

Accreditation of Food Protection Manager Certification Programs.*

The Food Code states the person in charge of a food establishment is 

accountable for developing, carrying out, and enforcing procedures aimed 

at preventing food-borne illness. Section 2-102.11 states that one means 

by which a person in charge may demonstrate required knowledge of food 

safety is through certification as a food protection manager by passing an 

examination that is part of an accredited program.** 

FDA encourages food regulatory authorities and others evaluating 

credentials for food protection managers to recognize the Conference for 

Food Protection/ANSI means of accrediting certification programs. This 

procedure provides a means for universal acceptance of individuals who 

*The ANSI-CFP Accreditation Program list of accredited organizations utilizing the Conference for Food Protection 

(CFP) Standards may be viewed on-line by going to:

https://www.ansica.org/wwwversion2/outside/ALLdirectoryListing.asp?menuID=8&prgID=8&status=4

** Accredited program does not refer to training functions or educational programs.
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 17

successfully demonstrate knowledge of food safety. The procedure 

provides officials assurance that food safety certification is based on valid, 

reliable, and legally defensible criteria. In addition, universal acceptance 

eliminates the inconvenience and unnecessary expense of repeating 

training and testing when managers work across jurisdictional boundaries. 

FDA, along with State, local, tribal, and other Federal agencies and the 

food industry, share the responsibility for ensuring that our food supply is 

safe. It is anticipated that this new Conference for Food Protection/ANSI 

program will lead to enhanced consumer protection, improve the overall 

level of food safety, and be an important component of a seamless 

national food safety system.”

Duties

2-103.11 Person in Charge.

A primary responsibility of the person in charge is to ensure compliance with Code 

requirements. Any individual present in areas of a food establishment where food and 

food-contact items are exposed presents a potential contamination risk. By controlling 

who is allowed in those areas and when visits are scheduled and by assuring that all 

authorized persons in the establishment, such as delivery, maintenance and service 

personnel, and pest control operators, comply with the Code requirements, the person 

in charge establishes an important barrier to food contamination. 

Tours of food preparation areas serve educational and promotional purposes; however, 

the timing of such visits is critical to food safety. Tours may disrupt standard or routine 

operational procedures, and the disruption could lead to unsafe food. By scheduling 

tours during nonpeak hours the opportunities for contamination are reduced. 

When food and other purchased goods are delivered and placed into designated 

locations within the food establishment during non-operating hours, the Person in 

Charge must make sure food employees inspect such product and verify that it is from 

the appropriate supplier, is in the desired condition, and was delivered to a proper 

storage location. Distributors deliver and place food and other goods in refrigeration 

units, freezers, and dry storage areas for confirmation of receipt and inspection by 

employees immediately upon arrival to the food establishment. Distributors contracted 

by the food establishment are often given a key to allow access into the establishment 

outside of normal working hours. Upon delivery, all food must be appropriately stored in 

a safe and secure manner within the food establishment. For example, time/temperature 

control for safety foods must be stored within refrigeration units and held at 

temperatures of 41°F or below. Likewise, if the food product is frozen, it must be placed 

into the freezer.

To minimize the potential for access to the food establishment and the food by an 

unauthorized person, precautions should be applied overall to the food establishment 

and especially when access to the facility is made under key access deliveries. 
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Additional information on food defense can be viewed at:

http://www.fda.gov/Food/FoodDefense/default.htm

An important duty of the Person in Charge is to make sure that any required 

temperatures are achieved or maintained when foods are cooked, cooled, thawed or 

held in a food establishment. By making it a duty of the Person in Charge to ensure that 

employees are monitoring food temperatures to verify the critical temperature limits, the 

likelihood of temperature abuse is reduced. This includes oversight of temperature 

monitoring to ensure: 1) that animal foods are being cooked to the required minimum 

temperatures to prevent the survival of pathogens that may be present (2-103.11(G)); 2) 

that cooked foods are being cooled rapidly to ensure that the growth of bacterial 

pathogens and toxin production is prevented (2-103.11(H)); and 3) that temperatures for 

time/temperature control for safety foods are routinely monitored during thawing to 

ensure that the growth of bacterial pathogens and toxin production is prevented

(¶2-103.11(J) and 4) that foods that require temperature control for safety are being 

held at temperatures that adequately prevent pathogen growth and toxin production 

(new ¶2-103.11(I)).

Food allergy is an increasing food safety and public health issue, affecting 

approximately 4% of the U.S. population, or twelve million Americans. Restaurant and 

retail food service managers need to be aware of the serious nature of food allergies, 

including allergic reactions, anaphylaxis, and death; to know the nine major food 

allergens; to understand food allergen ingredient identities and labeling; and to avoid 

cross-contact during food preparation and service. The 2008 Conference of Food 

Protection (CFP) passed Issue 2008-III-006 which provided that food allergy awareness 

should be a food safety training duty of the Person in Charge. Accordingly, the Person 

in Charge’s Duties under paragraph (M) were amended to assure the food safety 

training of employees includes food allergy awareness in order for them to safely 

perform duties related to food allergies. 

Paragraph (O) “EMPLOYEES are properly trained in FOOD safety, including food allergy 

awareness, as it relates to their assigned duties...” allows industry to develop and 

implement operational-specific training programs for food employees. It is not intended 

to require that all food employees pass a test that is part of an accredited program. 

Conducting training for employees on major food allergens and the symptoms they can 

cause in a sensitive individual is an essential step in preventing unintended food 

allergen exposure to the consumer. Food allergic consumers often ask employees to 

share information on ingredients and allergens. Having employees trained on the 

elements associated with food allergies is integral in addressing the needs of having 

informed employees. A food establishment developing operational specific allergen 

training programs for employees may consider incorporating topics including, but not 

limited to: 

• Risks of offering food containing major food allergens;

• Identification of the major food allergens and the hazards they present to 

sensitive individuals;
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Annex 3 - 19

• Recognition of symptoms of an allergic reaction and how to respond;

• Food allergen ingredient identification and labeling;

• Principles of allergen cross-contact prevention concerning the major food 

allergens; and

• Food establishment specific procedures, processes, communication and 

controls for allergen management.

Paragraph (P) emphasizes the important role the Person in Charge (PIC) has in making 

sure employees properly report certain information about their health status as it relates 

to diseases that are transmitted by food. In an effort to reinforce dialogue between food 

employees and the PIC, there must be a way to verify that food employees and 

conditional employees are informed of their responsibility to report such information. 

Examples of ways to verify that employees have been appropriately informed include:

• The ability to provide documentation that all food employees and conditional 

employees are informed of their responsibility to report to management, such as 

completion of Form 1-B, “Conditional Employees or Food Employees Reporting 

Agreement” in Annex 7 or other similar state or local forms containing the same 

information; 

• Presenting evidence such as curriculum and attendance rosters documenting 

that each employee has completed a training program which includes all the 

information required for reporting in Form 1-B; 

• Implementation of an employee health policy that includes a system of employee 

notification using a combination of training, signs, pocket cards or other means to 

convey all the required information (Refer to Annex 3, 2-201 Infected Food

Employees and Conditional Employees Practical Applications of Using Subpart 

2-201, for further guidance); 

• Other methods that satisfactorily demonstrate that all food employees and 

conditional employees are informed of their responsibility to report to the PIC 

information about their health and activities as it relates to diseases that are 

transmissible through food, as specified under ¶2-201.11 (A)

In various places throughout the Code, it is specified that either written operating 

procedures or operational plans be developed. The link between management 

responsibility for developing and implementing the procedures or plans is now 

established as a new duty for the Person in Charge (PIC). This new provision does not 

establish new requirements in the development of plans or procedures; rather it 

emphasizes the importance of the role the PIC plays in ensuring active managerial 

control of the food establishment with the development and implementation of plans 

and/or procedures as specified in this Code. Examples of Code provisions that call for 

the development of plans or procedures can be found in: §2-501.11, ¶¶3-301.11(D) and 

3-401.14 (F), §§ 3-501.19, and 5-205.14. Ultimately, responsibility for food safety at the 

retail level lies with retail and food service operators and their ability to develop and 

maintain effective food safety management systems. There are many tools that industry 

can use to develop an effective system to achieve active managerial control of 

foodborne illness risk factors. An important tool in controlling risk factors inherent in a 
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 20

food establishment is the development and implementation of written procedures or 

plans. 

(Also refer to Annex 4 – Management of Food Safety Practices (1) (D) for further 

information).

2-2 Employee Health

Overall goals.

The purpose of this section of the Food Code is to reduce the likelihood that certain viral 

and bacterial agents will be transmitted from infected food employees into food. The 

agents of concern are known to be readily transmissible via food that has been 

contaminated by ill food employees, and so for that reason, are the primary focus of the 

Employee Health section of the Food Code. However, there are different levels of risk 

associated with different levels of clinical illness. The structure of the restrictions and 

exclusions has, therefore, been designed in a tiered fashion depending on the clinical 

situation to offer the maximum protection to public health with the minimal disruption to 

employees and employers.

Four levels of illness or potential illness have been identified with the first level being the 

highest potential risk to public health and the fourth level being the lowest. The first level 

relates to employees who have specific symptoms (e.g., vomiting, diarrhea, jaundice) 

while in the workplace. These symptoms are known to be associated commonly with the 

agents most likely to be transmitted from infected food employees through 

contamination of food. The first level also relates to employees who have been 

diagnosed with typhoid fever or an infection with hepatitis A virus (within 14 days of 

symptoms). The second level relates to employees who have been diagnosed with the 

specific agents that are of concern, but who are not exhibiting symptoms of disease 

because their symptoms have resolved. The third level relates to employees who are 

diagnosed with the specific agents, but never develop any gastrointestinal symptoms. 

The fourth level relates to those individuals who are clinically well but who may have 

been exposed to a listed pathogen and are within the normal incubation period of 

disease.

The most significant degree of restriction and exclusion applies to the first level of food 

employee illness. Infected food employees in the first level are likely to be excreting 

high levels of their infectious pathogen, increasing the chance of transmission to food 

products, and thus on to those consuming the food. The first level includes food 

employees who are:

• Experiencing active symptoms of diarrhea or vomiting – with no diagnosis,

• Experiencing jaundice within the last 7 days-- with no diagnosis,

• Diagnosed with typhoid fever,

• Diagnosed with hepatitis A within 7 days of jaundice or 14 days of any 

symptoms, or
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Annex 3 - 21

• Experiencing active symptoms of diarrhea or vomiting, and diagnosed with 

Norovirus, E. coli O157:H7 or other Shiga toxin-producing Escherichia coli

(STEC), Shigella spp. infection, or nontyphoidal Salmonella.

Diagnosis with typhoid fever or hepatitis A virus is included in level 1 because 

employees diagnosed with these pathogens are likely to be shedding high levels of the 

pathogen in their stool without exhibiting gastrointestinal symptoms. Peak levels of 

hepatitis A viral shedding in the feces typically occurs before symptoms appear. 

Diarrhea and vomiting are reliable indicators of infection with Norovirus, E. coli

O157:H7 or other STEC, and Shigella spp., but are not typical symptoms of typhoid 

fever or hepatitis A. For example, employees diagnosed with typhoid fever are more 

likely to experience constipation, rather than diarrhea. Jaundice is also not always 

reliable as an indicator of a hepatitis A infection because employees can be infected 

with hepatitis A virus without experiencing jaundice (anicteric employees). Dark urine 

and light colored stool may be an indicator of a hepatitis A infection but may go 

unreported.

Maximum protection to public health requires excluding food employees suffering from 

typhoid fever, hepatitis A virus, or specific gastrointestinal symptoms associated with 

diseases identified as likely to be transmitted through contamination of food (See 

section 2-201.12, Tables 2-201.12 #1a and #1b in this Annex). This situation describes 

the highest level of risk in transmitting pathogens to food, or what we would find in the 

first level. 

Food employees who have been diagnosed with one of the agents of concern, but are 

not symptomatic because their symptoms have resolved, are still likely to be carrying 

the infected agent in their intestinal tract. This makes such employees less likely to 

spread the agent into food than others who are actually symptomatic, but employees 

diagnosed with one of the agents of concern still pose an elevated threat to public 

health. For this reason, there are a series of exclusions (if the employees work in 

facilities serving highly susceptible populations (HSP)) and restrictions (for non-HSP 

facilities) depending on the agent involved (See section 2-201.12, Table #2). This 

situation describes the second level of risk in transmitting pathogens to food. 

Diagnosed, asymptomatic food employees who never develop symptoms are typically 

identified during a foodborne illness outbreak investigation through microbiological 

testing. If infected and asymptomatic employees are not microbiologically tested, they 

will remain undetected and could therefore extend the duration of a foodborne illness 

outbreak through continued contamination of food. The Food Code provides restriction 

or exclusion guidelines for employees that are identified through microbiological testing 

with an infection from a listed foodborne pathogen, but are otherwise asymptomatic and 

clinically well (See section 2-201.12, Table #3). The exclusion or restriction guidelines 

are applied until the identified food employees no longer present a risk for foodborne 

pathogen transmission. This situation describes the third level of risk in transmitting 

pathogens to food. 

Some food employees or conditional employees may report a possible exposure to an

agent. For example, a food employee may have attended a function at which the food 
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Annex 3 - 22

employee ate food that was associated with an outbreak of shigellosis, but the 

employee remains well. Such individuals fall into the category of having had a potential 

exposure and present a lower risk to public health than someone who is either 

symptomatic or who has a definitive diagnosis. They present a level of risk to public 

health that is greater than if they had not had the exposure. The approach taken in the 

Food Code to food employees who have had a potential exposure is based on the 

incubation times (time between exposure and the onset of symptoms) of the various 

agents. The times chosen for restriction are the upper end of the average incubation 

periods for the specific agents. The Food Code provides restriction guidelines for food 

employees working in facilities serving a HSP. The reasoning is that this will restrict 

food employees only up to the time when it is unlikely they will develop symptoms. As a 

further protection to public health, it is recommended that such exposed food 

employees working in facilities not serving a HSP pay particular attention to personal 

hygiene and report the onset of any symptoms (See section 2-201.12, Table #4). This 

situation describes the fourth level of risk in transmitting pathogens to food. 

This structured approach has linked the degree of exclusion and restriction to the 

degree of risk that an infected food employee will transmit an agent of concern into 

food. The approach strikes a balance between protecting public health and the needs of 

the food employee and employer. 

The Food Code provisions related to employee health are aimed at removing highly 

infectious food employees from the work place. They were developed with recognition 

of the characteristics of the six important pathogens, and of the risk of disease 

transmission associated with symptomatic and asymptomatic shedders. The provisions 

also account for the increased risk associated with serving food to HSP’s and the need 

to provide extra protection to those populations. 

The Employee Health section was developed and revised with assistance and input 

from the Centers for Disease Control and Prevention (CDC) and the U.S. Equal 

Employment Opportunity Commission (EEOC). The exclusion and restriction criteria are 

based on communicable disease information, as required by the Americans with 

Disabilities Act of 1990, in the list of Pathogens Transmitted by Food Contaminated by 

Infected Persons Who Handle Food, and Modes of Transmission of Such Pathogens

posted on CDC’s website, and from the Control of Communicable Diseases Manual, 

19th Ed., David L. Heymann, MD, Editor, by the American Public Health Association, 

Washington D.C., 2008.

2-201 Infected Food Employees and Conditional Employees 

Practical Applications of Using Subpart 2-201

The information provided in Subpart 2-201 is designed to assist food establishment 

managers and regulatory officials in removing infected food employees when they are at 

greatest risk of transmitting foodborne pathogens to food. Practical applications of the 

information in Subpart 2-201 by a food establishment manager may involve using 

Subpart 2-201 as a basis for obtaining information on the health status of food 

employees and can also be used as a basis in developing and implementing an 
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 23

effective Employee Health Policy. Regulatory officials can benefit by using the 

information provided below as a basis for determining compliance with Subpart 2-201 

during a facility food safety inspection.

The development and effective implementation of an employee health policy based on 

the provisions in Subpart 2-201 may help to prevent foodborne illness associated with 

contamination of food by ill or infected food employees. The person in charge and food 

employees should be familiar with and able to provide the following information through 

direct dialogue or other means when interviewed by facility managers or regulatory 

officials. Compliance must be based, however, on first hand observations or information 

and cannot be based solely on responses from the person in charge to questions 

regarding hypothetical situations or knowledge of the Food Code. Also, when designing 

and implementing an employee health policy, the following information should be 

considered and addressed:

1. Does the establishment have an Employee Health Policy? If so, are the food 

employees aware of the employee health policy, and is it available in written 

format and readily available for food employees? (Note: A written Employee

Health Policy is not a Food Code requirement unless the facility is operating 

under a pre-approved alternative procedure specified under ¶3-301.11(E)).

2. Does the establishment require conditional employees and food employees to 

report certain illnesses, conditions, symptoms, and exposures?

3. Are the reporting requirements explained to all employees?

4. What are the reporting requirements for conditional employees, food employees, 

and the food establishment manager?

5. Are conditional employees asked if they are experiencing certain symptoms or 

illnesses upon offer of employment? If so, which symptoms or illnesses?

6. If a food employee reports a diagnosis with one of the 6 listed pathogens in the 

Food Code, what questions are asked of the food employee? (The first question 

every food manager should ask a food employee who reports diagnosis with a 

listed pathogen is if the employee is currently having any symptoms.)

7. Who does the establishment notify when a food employee reports a diagnosis 

with one of the listed pathogens? 

8. What gastrointestinal symptoms would require exclusion of a food employee from 

the food establishment? 

9. What history of exposure is a conditional employee or food employee required to 

report? 

10.If a food employee reports a gastrointestinal symptom, what criteria are used to 

allow the employee to return to work? 
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Annex 3 - 24

Responsibilities and Reporting Symptoms and Diagnosis

2-201.11 Responsibility of the Person in Charge, Food 

Employees, and Conditional Employees. 

Proper management of a food establishment operation begins with employing healthy 

people and instituting a system of identifying employees who present a risk of 

transmitting foodborne pathogens to food or to other employees. The person in charge 

is responsible for ensuring all food employees and conditional employees are 

knowledgeable and understand their responsibility to report listed symptoms, diagnosis 

with an illness from a listed pathogen, or exposure to a listed pathogen to the person in 

charge. The person in charge is also responsible for reporting to the regulatory official if 

a food employee reports a diagnosis with a listed pathogen.

This reporting requirement is an important component of any food safety program. A 

food employee who suffers from any of the illnesses or medical symptoms or has a 

history of exposure to a listed pathogen in this Code may transmit disease through the 

food being prepared. The person in charge must first be aware that a food employee or 

conditional employee is suffering from a disease or symptom listed in the Code before 

steps can be taken to reduce the chance of foodborne illness. 

The person in charge may observe some of the symptoms that must be reported. 

However, food employees and conditional employees share a responsibility for 

preventing foodborne illness and are obligated to inform the person in charge if they are 

suffering from any of the listed symptoms, have a history of exposure to one of the listed 

pathogens, or have been diagnosed with an illness caused by a listed pathogen. Food 

employees must comply with restrictions or exclusions imposed upon them. 

A conditional employee is a potential food employee to whom a job offer has been 

made, conditional on responses to subsequent medical questions or examinations. The 

questions or examinations are designed to identify potential food employees who may 

be suffering from a disease that can be transmitted through food and done in 

compliance with Title 1 of the Americans with Disabilities Act of 1990. A conditional 

employee becomes a food employee as soon as the employee begins working, even if 

only on a restricted basis. When a conditional employee reports a listed diagnosis or 

symptom, the person in charge is responsible for ensuring that the conditional employee 

is prohibited from becoming a food employee until the criteria for reinstatement of an 

exclusion are met (as specified under section 2-201.13 of the Food Code). When a 

symptomatic or diagnosed conditional employee has met the same criteria for 

reinstatement that apply to an excluded symptomatic or diagnosed food employee (as 

specified under section 2-201.13 of the Food Code), the conditional employee may then 

begin working as a food employee.

Reporting Symptoms:

In order to protect the health of consumers and employees, information concerning the 

health status of conditional employees and food employees must be disclosed to the 

person in charge. The symptoms listed in the Code cover the common symptoms 
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 25

experienced by persons suffering from the pathogens identified by CDC as 

transmissible through food by infected food employees. A food employee suffering from 

any of the symptoms listed presents an increased risk of transmitting foodborne illness. 

The symptoms of vomiting, diarrhea, or jaundice serve as an indication that an 

individual may be infected with a fecal-oral route pathogen, and is likely to be excreting 

high levels of the infectious agent. When a food employee is shedding extremely high 

numbers of a pathogen through the stool or vomitus, there is greater chance of 

transmitting the pathogen to food products. 

Sore throat with fever serves as an indication that the individual may be infected with 

Streptococcus pyogenes. Streptococcus pyogenes causes a common infection 

otherwise known as “streptococcal sore throat” or “strep throat.” Streptococcal sore 

throat can spread from contaminated hands to food, which has been the source of 

explosive streptococcal sore throat outbreaks. Previous foodborne episodes with 

streptococcus sore throat have occurred in contaminated milk and egg products. Food 

products can be contaminated by infected food employees hands or from nasal 

discharges. Untreated individuals in uncomplicated cases can be communicable for 10-

21 days, and untreated individuals with purulent discharges may be communicable for 

weeks or months. 

Lesions containing pus that may occur on a food employee’s hands, as opposed to 

such wounds on other parts of the body, represent a direct threat for introducing 

Staphylococcus aureus into food. Consequently, a double barrier is required to cover 

hand and wrist lesions. Pustular lesions on the arms are less of a concern when usual 

food preparation practices are employed and, therefore, a single barrier is allowed. 

However, if the food preparation practices entail contact of the exposed portion of the 

arm with food, a barrier equivalent to that required for the hands and wrists would be 

necessitated. Lesions on other parts of the body need to be covered; but an 

impermeable bandage is not considered necessary for food safety purposes. Food 

employees should be aware that hands and fingers that contact pustular lesions on 

other parts of the body or with the mucous membrane of the nose also pose a direct 

threat for introducing Staphylococcus aureus into food. 

If a food employee has an infected cut and bandages it and puts on a glove, the 

employee does not have to report the infected cut to the person in charge. However, if 

the employee does not bandage it, reporting is required. 

Title I of the Americans with Disabilities Act of 1990 (ADA)

Title I of the Americans with Disabilities Act of 1990 (ADA) prohibits medical 

examinations and inquiries as to the existence, nature, or severity of a disability before 

extending a conditional offer of employment. In order for the permit holder and the 

person in charge to be in compliance with this particular aspect of the Code and the 

ADA, a conditional job offer must be made before making inquiries about the applicant’s 

health status. 
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 26

The ADA also requires that employers provide reasonable accommodation to qualified 

applicants and employees with disabilities. A reasonable accommodation is a change in 

the application process, in the way a job is done, or to other parts of the job that enables 

a person with a disability to have equal employment opportunities. ADA disabilities are

serious, long-term conditions. Most people with diseases resulting from the pathogens 

listed in the Food Code do not have ADA disabilities because these diseases are 

usually short-term in duration. In addition, the gastrointestinal symptoms listed in the 

Food Code usually are not long-term and severe enough, in themselves, to be ADA 

disabilities. Of course, these symptoms may be linked to other conditions that may be 

serious enough to be ADA disabilities, like Crohn’s disease or cancer. 

A food employer may exclude any employee under the Food Code upon initially 

learning that the employee has Typhoid fever (caused by Salmonella Typhi), or has a 

gastrointestinal symptom listed in the Food Code. The excluded employee may then 

ask for an ADA reasonable accommodation instead of the exclusion. In response, the 

employer’s first step should be to ask the employee to establish that the employee is 

disabled by the disease or symptom (or that the symptom is caused by another ADA 

disability). If the employee successfully proves that the employee has an ADA disability, 

then the employer may continue to exclude the employee under the Food Code if: 

• There is no reasonable accommodation at work that would eliminate the risk of 

transmitting the disease while also allowing the employee to work in a food 

handling position, or 

• All reasonable accommodations would pose an undue hardship on the 

employer’s business; and

• There is no vacant position not involving food handling for which the employee is 

qualified and to which the employee can be reassigned.

Example 1: A food employee working in the café of a department store informs the 

employer that the employee has been diagnosed with Typhoid fever (caused by 

Salmonella Typhi). The employer immediately excludes the employee under the 

requirements of the Food Code. The employee then establishes that the disease is an 

ADA disability because it is severe and long-term and the employee requests 

reasonable accommodation instead of an exclusion. The employer determines that no 

reasonable accommodation would eliminate the risk of transmitting Typhoid fever

(caused by Salmonella Typhi) through food and refuses to remove the exclusion. 

However, there is a vacant clerical position in another part of the store for which the 

employee is qualified. Unless the employer can establish that reassigning the employee 

to this position would be an undue hardship, the employer’s failure to make the 

reassignment instead of continuing the exclusion would be a violation of the ADA.2

2 Whether or not the employee in question is an individual with an ADA disability, in those jurisdictions where the 

Code is adopted, Food Code exclusions or restrictions must be removed when requirements for removal under 

§ 2-201.13 of the Code are met.
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Annex 3 - 27

Example 2: A food employee has diarrhea and is excluded. The employee establishes 

that the diarrhea is caused by Crohn’s disease. This employee also establishes a 

serious longstanding history of Crohn’s disease and is an individual with an ADA 

disability. Crohn’s disease is not a communicable disease and cannot be transmitted 

through food. No reasonable accommodation is needed to eliminate the risk of 

transmitting the disease through the food supply, so the Food Code exclusion should be 

removed. Of course, the Food Code’s provisions on personal cleanliness for hands and

arms apply as usual, requiring employees to clean hands and exposed portions of arms 

after using the toilet room and in other specified circumstances (Subpart 2-301).

Somewhat different rules apply to conditional employees. If a conditional employee 

reports a disease or symptom listed in the Food Code and shows that the disease or 

symptom makes the conditional employee an individual with an ADA disability, the 

employer may withdraw the job offer only if:

• The job involves food handling; and

• The employer determines that either there is no reasonable accommodation that 

would eliminate the risk of transmitting the disease through food, or any such 

accommodation would be an undue hardship to the business. 

• There is no need to offer the conditional employee a vacant position not involving 

food handling as a reasonable accommodation. 

It should be noted that the information provided here about the ADA is intended to alert 

employers to the existence of ADA and related CFR requirements. For a 

comprehensive understanding of the ADA and its implications, consult the references 

listed in Annex 2 that relate to this section of the Code or contact the U. S. Equal 

Employment Opportunity Commission. See the Equal Employment Opportunity 

Commission’s How to Comply with the Americans with Disabilities Act: A Guide for 

Restaurants and Other Food Service Employers, found at 

http://www.eeoc.gov/facts/restaurant_guide.html or 

http://www.eeoc.gov/facts/restaurant_guide_summary.html for detailed information 

about the interaction between the FDA Food Code and the ADA.

The information required from applicants and food employees is designed to identify 

employees who may be suffering from a disease that can be transmitted through food. It 

is the responsibility of the permit holder to convey to applicants and employees the 

importance of notifying the person in charge of changes in their health status. Once 

notified, the person in charge can take action to prevent the likelihood of the 

transmission of foodborne illness. Applicants, to whom a conditional offer of 

employment is extended, and food employees are required to report their specific 

history of exposure, medical symptoms, and previous illnesses. The symptoms listed 

may be indicative of a disease that is transmitted through the food supply by infected 

food employees. 

Section 103 (d) of the Americans with Disabilities Act of 1990, Public Law 101–336, 

requires the Secretary to publish a list of infectious and communicable diseases that are 
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 28

transmitted through handling the food supply and to review and update the list annually.

The CDC published on its website in November 2012 a list of Pathogens Transmitted by 

Food Contaminated by Infected Persons Who Handle Food, and Modes of 

Transmission of Such Pathogens. See the list at: 

https://www.cdc.gov/foodsafety/pdfs/ada2017_transmittedbyfood_final.pdf

The final list has been reviewed in light of new information and has been revised as set 

forth below.

Pathogens Transmitted by Food Contaminated by Infected Persons Who Handle 

Food, and Modes of Transmission of Such Pathogens. 

Some pathogens are frequently transmitted by food contaminated by infected persons. 

The presence of any one of the following signs or symptoms in persons who handle 

food may indicate infection by a pathogen that could be transmitted to others through 

handling the food supply: diarrhea, vomiting, open skin sores, boils, fever, dark urine or 

jaundice. The failure of food-handlers to wash hands in certain situations (such as after 

using the toilet, handling raw meat, cleaning spills, or carrying garbage), wear clean 

disposable gloves, or use clean utensils is responsible for the foodborne transmission of 

these pathogens. Non-foodborne routes of transmission, such as from one person to 

another, are also major contributors in the spread of these pathogens. 

Some pathogens usually cause disease when food is intrinsically contaminated or 

cross-contaminated during production, processing or transportation, but may also be 

contaminated when prepared by infected persons. Bacterial pathogens in this category 

often cause disease after bacteria have multiplied in food after it has been kept at 

improper temperatures permitting their multiplication to an infectious dose. Preventing 

food contact by persons who have an acute diarrheal illness will decrease the risk of 

transmitting these pathogens. 

The following represent both types of pathogens that may be transmitted by an infected 

food handler: 

• Astroviruses 

• Bacillus cereus 

• Campylobacter jejuni 

• Clostridium perfringens 

• Cryptosporidium species 

• Entamoeba histolytica 

• Enterohemorrhagic E. coli

• Enterotoxigenic E. coli

• Giardia intestinalis 

• Hepatitis A virus 

• Nontyphoidal Salmonella

• Noroviruses 

• Rotaviruses 

• Salmonella Typhi* 
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Annex 3 - 29

• Sapoviruses 

• Shigella species 

• Staphylococcus aureus 

• Streptococcus pyogenes 

• Taenia solium - cysticercosis 

• Vibrio cholera 

• Yersinia enterocolitica 

* 1. Kauffmann-White scheme for designation of Salmonella serotypes

The Six (6) Listed Pathogens.

The CDC has designated the six (6) organisms listed in the Food Code as having high 

infectivity via contamination of food by infected food employees. This designation is 

based on the number of confirmed cases reported that involved food employees 

infected with one of these organisms and/ or the severity of the medical consequences 

to those who become ill. 

The following is taken from information provided in the 19th Edition of Control of 

Communicable Diseases Manual, the CDC website, and the FDA Bad Bug Book, 2nd

Edition, and is provided as background information on pathogen virulence, infectivity, 

and common symptoms exhibited with infection of each of the 6 listed pathogens. 

1. NOROVIRUS

Noroviruses (genus Norovirus, family Caliciviridae) are small (27-40 nm), round 

structured, single-stranded RNA, nonenveloped viruses. They are a genetically diverse 

group classified into at least five genogroups, designated GI-GV, which are further subdivided into at least 35 genotypes. Noroviruses are recognized as the most common 

cause of epidemic and sporadic gastroenteritis across all age groups worldwide.

Transmission of norovirus occurs primarily through the fecal-oral route, including direct 

person-to-person contact and indirect transmission through contaminated food, water, 

or environmental surfaces. Vomitus-oral transmission can also occur through 

aerosolization followed by direct ingestion or environmental contamination. 

Noroviruses are the leading cause of foodborne illness in the United States. Food 

handler contact with raw or other ready-to-eat foods is the most common scenario 

resulting in foodborne norovirus outbreaks. Norovirus contamination of produce and 

shellfish can also occur during production. Secondary household transmission is 

common. 

Noroviruses are environmentally stable, able to survive both freezing and heating 

(although not thorough cooking), are resistant to many common chemical disinfectants, 

and can persist on surfaces for up to 2 weeks. Proper hand hygiene and exclusion of 

food employees exhibiting symptoms of norovirus disease (i.e., diarrhea or vomiting) 

are critical for norovirus control.
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Incubation Period: 

In volunteer studies, the range is 10-50 hours. In foodborne norovirus outbreaks, the 

median incubation period is 33 hours. 

Symptoms and Complications: 

Acute-onset of vomiting, watery non-bloody diarrhea, abdominal cramps, and nausea,

or a combination of these symptoms. Low grade fever and body aches may also be 

associated. Symptoms typically last 24 to 72 hours. Norovirus disease is usually selflimited without any serious long-term sequelae. Among the young and the elderly, 

dehydration is a common complication. Volunteer studies have found that as many as 

30% of individuals infected with norovirus are asymptomatic. There is no specific 

treatment for norovirus disease. Supportive therapy consists of oral or intravenous 

rehydration solutions to replace fluid loss and electrolytes. Previous exposure does not 

provide long-term immunity; thus, individuals may be repeatedly infected throughout 

their lifetimes.

Infectivity: 

Noroviruses are highly contagious, and it is thought that an inoculum of as few as 18 

viral particles may be sufficient to infect an individual. Although pre-symptomatic 

shedding may occur, shedding usually begins with onset of symptoms, peaks 4 days 

after exposure, and may persist for 3 weeks after recovery. However the degree of 

infectivity of prolonged shedding has not been determined and peak contagiousness is 

during the acute stage of disease. Peak viral loads in both symptomatic and 

asymptomatic infections (may be as high as 100 billion viral particles/g feces).

2. NONTYPHOIDAL SALMONELLA

Caused by serotypes other than S. Typhi and S. Paratyphi A. 

Unlike previous editions of the FDA Food Code, the 2013 edition requires food 

employees to report a diagnosis of nontyphoidal Salmonella (NTS), prompts the person 

in charge to exclude food employees with diagnosis of NTS, and provides conditions for 

reinstatement of a food employee who provides to the person in charge written medical 

documentation from a health practitioner that states the food employee is free from 

NTS, and where appropriate, approval from the regulatory authority.

Nontyphoidal Salmonella (NTS) enterica serotypes are among the most common 

bacterial cause of foodborne illness. NTS are estimated to cause more than one million 

domestically acquired foodborne illnesses in the United States each year (Scallan et. al. 

2011), and are the leading cause of hospitalizations and deaths due to foodborne illness 

in the United States (Barton-Behravesh et al. 2011, CDC 2011). Whereas reductions in 

incidence have been achieved for many other foodborne pathogens in recent years, no 

significant change in incidence of NTS infections has occurred since the start of 

FoodNet surveillance during 1996–1998 (CDC 2011). Therefore, further interventions 

are needed to reduce the incidence of NTS infections. 
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Annex 3 - 31

Commercial food establishments are an important setting for the transmission of NTS, 

both in the form of recognized foodborne disease outbreaks as well as sporadic 

infections. During 1998 to 2002, the 585 Salmonella enterica outbreaks reported to the 

Centers for Disease Control and Prevention accounted for 49% of all bacterial 

outbreaks (Lynch et al. 2006). Forty-six percent of Salmonella outbreaks occurred in 

restaurant/deli establishments, the most common setting for Salmonella outbreaks 

(Lynch et al. 2006). For the period of 2009-2010, the 243 Salmonella outbreaks 

reported to the CDC accounted for 51% of bacterial foodborne disease outbreaks. 

Outbreaks of salmonellosis at commercial food establishments frequently involve direct 

transmission to patrons from fresh produce or undercooked foods of animal origin, or 

cross contamination from these foods. However, numerous NTS outbreak investigations 

have implicated food workers as the source of the outbreak or strongly suggested 

transmission from food workers (Ethelberg et al. 2004; Greig et al. 2007; Hedberg et. al. 

1991; Hedican et al. 2009; Hundy and Cameron 2002; Khuri-Bulos et al. 1994; Maguire 

et al. 2000; Medus et al. 2006; Todd et al 2007a, 2007b).

In a study of restaurant-associated salmonellosis outbreaks in Minnesota published by 

Medus et al. (2006), the importance of infected food workers as a source of 

contamination in the outbreaks was supported by several observations. First, a specific 

food vehicle was statistically implicated or suspected in a low proportion of the 

restaurant outbreaks (39%), which suggests that the specific food items or food 

handling errors were not the primary causes for these outbreaks. Second, food workers 

infected with NTS were identified in the majority (83%) of the outbreak investigations. 

Infected food workers who reported a history of illness shed NTS in the stool for a 

median of 1 month. The authors concluded that regardless of the original source of a 

Salmonella outbreak in a restaurant (e.g., raw meat or eggs), the initial source of a 

salmonellosis outbreak, food workers frequently serve as reservoirs for NTS and 

contribute to transmission to patrons. Thus, assessment of food worker history, i.e., 

symptoms and exposures, testing of stool samples and exclusion or restriction of 

infected food workers from the food establishment are essential for controlling 

restaurant-associated outbreaks of salmonellosis.

In a study of food workers with salmonellosis who were detected through routine 

surveillance (Medus et al. 2010), 2.2% of identified culture-confirmed Salmonella cases 

were food workers, and identification of these cases were critical to the identification of 

numerous outbreaks. The authors concluded that the rapid identification and follow-up 

of food workers among reported cases of salmonellosis is important to the early 

detection and control of outbreaks in restaurant settings. Importantly, even hostesses, 

servers, bartenders, and others who theoretically have limited food preparation duties 

can serve as sentinels of transmission within the restaurant. The authors also stated 

that food workers should be considered an important source of Salmonella

transmission, and those identified through surveillance should raise a high index of 

suspicion of a possible outbreak at their place of work. Food service managers need to 

be alert to Salmonella-like illnesses among food workers to facilitate prevention and 

control efforts, including exclusion of infected food workers or restriction of their duties.
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Annex 3 - 32

The biology of NTS and the epidemiology of salmonellosis are complex; food workers 

may be an underappreciated part of that complexity. In order to decrease the incidence 

of NTS infections in the United States, commercial food establishments should also be 

targets for more focused prevention measures, and prevention and control efforts 

should consider food workers as an important source of NTS transmission.

General Description: 

Nontyphoidal Salmonella (NTS) enterica are bacteria that cause a diarrheal illness 

called salmonellosis. NTS are among the most common and important causes of enteric 

disease. An estimated 1.2 million cases occur annually in the United States; of these, 

approximately 42,000 are culture-confirmed cases reported to the Centers for Disease 

Control and Prevention.

Salmonella lives in the intestines of animals or humans. It can be found in water, food, 

soil, or surfaces that have been contaminated with the feces of infected animals or 

humans. People can become infected with Salmonella by:

• Eating foods contaminated with the bacteria. Contaminated foods are often of 

animal origin, such as beef, poultry, unpasteurized milk, or eggs. Fruits and 

vegetables may also be contaminated. Any food can be contaminated by an 

infected food handler.

• Contacting farm animals or pets (including reptiles, amphibians, chicks, and 

ducklings), animal feces, or animal environments.

• Touching contaminated surfaces or objects and then touching ones mouth or 

putting a contaminated object into ones mouth.

• Drinking contaminated water.

Most infections are thought to be acquired through consumption of contaminated food.

Incubation Period: 

Symptoms often begin 12 to 72 hours after being exposed to the bacteria, although it 

can take up to a week or more for symptoms to develop in some people.

Symptoms and Complications: 

Symptoms of salmonellosis include diarrhea, abdominal cramps, and fever. The illness 

usually lasts 4 to 7 days. Persons with NTS infections usually recover without treatment. 

However, in approximately 20% of persons, the illness is so severe that hospitalization 

is required. In these patients the NTS infection may spread from the intestine to the 

blood stream, and then to other body sites and can cause death unless the person is 

treated promptly with antibiotics. An estimated 400 fatal cases of salmonellosis occur 

each year. A small number of persons experience long-term consequences from NTS 

infections, such as arthritis that can last for months or years. 

Antibiotic treatment for salmonellosis is generally not indicated for typical intestinal 

illness. Antibiotics typically do not shorten the duration of illness or eliminate the carrier 
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 33

state. However, antibiotic treatment is recommended for persons who develop invasive 

(extraintestinal) infections, infants under 2 months of age, the elderly, or those who 

have certain underlying medical conditions that predispose them to invasive infection.

Infectivity:

The minimum infectious dose of NTS for humans is generally described as 100 to 1,000 

organisms. However, doses of fewer than 10 organisms have caused illness in multiple 

outbreaks. Persistence of NTS in the stool after the acute phase of illness is a well 

described consequence of NTS infections. This persistence is often referred to as a 

temporary carrier state, and the term “shedding” is used to describe the excretion of 

Salmonella in the stool. 

Studies have consistently shown that the median duration of shedding in the stool to be 

4 to 5 weeks after onset of acute gastroenteritis. Persons who have been exposed to 

NTS but who never develop symptoms can also be temporary carriers of NTS; these 

persons shed NTS for a shorter period of time than persons who experienced illness. 

Carriers of NTS are known to shed the bacteria in the stool intermittently. Treatment 

with antimicrobials does not eradicate NTS from stool and may actually prolong the 

duration of shedding.

3. SALMONELLA Typhi

Salmonella enterica subspecies enterica serovar Typhi (commonly S. Typhi) causes a 

systemic bacterial disease, with humans as the only host. This disease is relatively rare 

in the United States, with fewer than 500 sporadic cases occurring annually in the U.S. 

Worldwide, the annual estimated incidence of typhoid fever is about 17 million cases 

with approximately 600,000 deaths. Currently, most cases of S. Typhi in industrialized 

nations are imported into the country from developing countries. Antibiotic-resistant 

strains have become prevalent in several areas of the world. 

Incubation Period: 

Generally 1 to 3 weeks, but may be as long as 2 months after exposure. 

Symptoms and Complications: 

High fever, from 103° to 104°F; lethargy; gastrointestinal symptoms, including 

abdominal pains and diarrhea or constipation; headache; achiness; loss of appetite. A 

rash of flat, rose-colored spots sometimes occurs. Septicemia, with colonization of other 

tissues and organs; e.g., may lead to endocarditis. Septic arthritis may occur, in which 

the infection directly affects the joints and may be difficult to treat. Chronic infection of 

the gallbladder may occur, which may cause the infected person to become a carrier. 

Infectivity: 

The minimal infectious dose is estimated to be less than 1000 bacterial cells. An 

individual infected with S. Typhi is infectious as long as the bacilli appear in the excreta, 

usually from the first week throughout the convalescence; variable thereafter. About 
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Annex 3 - 34

10% of untreated typhoid fever patients will discharge bacilli for 3 months after onset of 

symptoms, and 2%-5% become permanent carriers.

4. SHIGA TOXIN-PRODUCING ESCHERICHIA COLI

E. coli O157:H7 is the most commonly identified serotype of Shiga toxin-producing 

Escherichia coli (STEC) as a cause of foodborne illness in the United States. E. coli

O157:H7 is a zoonotic disease derived from cattle and other ruminants. However, E. 

coli O157:H7 also readily transmits from person-to-person, so contaminated raw 

ingredients and ill food employees both can be sources of foodborne disease. Other 

STEC serotypes have been identified as a source of foodborne illness in the United 

States, however not as frequently as E. coli O157:H7. The other serogroups most 

commonly implicated as a cause of foodborne illness in the United States are O26, 

O111, O103, O45, and O121. 

The Food Code definition of STEC covers all E. coli identified in clinical laboratories 

that produce Shiga toxins. Nearly 200 O:H combinations of E. coli have been shown to 

produce Shiga toxins. The Food Code definition includes all STEC, including those that 

have not been specifically implicated in human disease such as hemorrhagic colitis (i.e., 

bloody diarrhea) or hemolytic uremic syndrome (HUS). Infections with STEC may be 

asymptomatic but are classically associated with bloody diarrhea (hemorrhagic colitis) 

and hemolytic uremic syndrome (HUS) or thrombotic thrombocytopenic purpura (TTP). 

[Note: “enterohemorrhagic” (EHEC) is a subset of STEC that has the capacity to both 

produce Shiga toxin and cause “attaching and effacing” lesions in the intestine.] 

Incubation period: 

Symptoms usually begin 3 to 4 days after exposure, but the time may range from 1 to 9 

days. 

Symptoms and Complications: 

Hemorrhagic colitis is characterized by severe cramping (abdominal pain), nausea or 

vomiting, and diarrhea that initially is watery, but becomes grossly bloody. In some 

cases, the diarrhea may be extreme, appearing to consist entirely of blood and 

occurring every 15 to 30 minutes. Fever typically is low-grade or absent. Infections from 

EHEC may range from asymptomatic to mild diarrhea to severe, life threatening 

complications (e.g., hemorrhagic colitis, hemolytic uremic syndrome)). About 3% to 7% 

STEC infections progress to HUS .

Infectivity: 

The infective dose of E. coli O157:H7 is estimated to be very low, in the range of 10 to 

100 cells. Children under 5 years old are most frequently diagnosed with infection and 

are at greatest risk of developing HUS. The elderly also experience a greater risk of 

complications. The duration of excretion of STEC in the stool is typically 1 week or less 

in adults, but can be up to 3 weeks or longer in one-third of infected children. 

5. SHIGELLA SPP. 
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Annex 3 - 35

Causes an acute bacterial disease, known as shigellosis, and primarily occurs in 

humans, but also occurs in other primates such as monkeys and chimpanzees. An 

estimated 300,000 cases of shigellosis occur annually in the U.S. Shigella spp. consist 

of 4 species or serogroups, including S. flexneri, S. boydii, S. sonnei, and 

S. dysenteriae; which all differ in geographical distribution and pathogenicity. Shigella

spp. are highly infectious and highly virulent. Outbreaks occur in overcrowding 

conditions, where personal hygiene is poor, including in institutions, such as prisons, 

mental hospitals, day care centers, and refugee camps, and also among men who have 

sex with men. Water and RTE foods contaminated by feces, frequently from food 

employees’ hands, are common causes of disease transmission. Multidrug-resistant 

Shigella (including S. dysenteriae type 1) have appeared worldwide. Concern over 

increasing antimicrobial resistance has led to reduced use of antimicrobial therapy in 

treating shigellosis. 

Incubation period: Eight to 50 hours.

Symptoms and Complications: 

Abdominal pain, diarrhea, fever, nausea, and sometimes vomiting, tenesmus, toxaemia, 

and cramps. The stools typically contain blood, pus, or mucus resulting from mucosal 

ulcerations. The illness is usually self-limited, with an average duration of 5-7 days. 

Infections are also associated with rectal bleeding, drastic dehydration, and convulsions 

in young children. The fatality rate for Shigella dysenteriae 1 may be as high as 20% 

among hospitalized cases. Other complications can also occur, such as reactive 

arthritis, intestinal perforation, and hemolytic uremic syndrome. 

Infectivity: 

The infectious dose for humans is low, with as few as 10 bacterial cells depending on 

age and condition of the host. Infectivity occurs during acute infection and until the 

infectious agent is no longer present in feces, usually within 4 weeks after illness. 

Asymptomatic carriers may transmit infection; rarely, the carrier state may persist for 

months or longer. 

6. Hepatitis A Virus

Hepatitis A virus (HAV) is a 27-nanometer picornavirus (positive strand RNA, nonenveloped virus). The hepatitis A virus has been classified as a member of the family 

Picornaviridae. The exact pathogenesis of HAV infection is not understood, but the virus 

appears to invade from the intestinal tract and is subsequently transported to the liver. 

The hepatocytes are the site of viral replication and the virus is thought to be shed via 

the bile. 

HAV is most commonly spread by the fecal-oral route through person-to-person contact. 

Risk factors for reported cases of hepatitis A include personal or sexual contact with 

another case, illegal drug use, homosexual male sex contact, and travel to an endemic 

country. Common source outbreaks also can occur through ingestion of water or food 
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 36

that has fecal contamination. However, the source of infection is not identified for 

approximately 50% of reported cases.

HAV infection is endemic in developing countries, and less common in industrialized 

countries with good environmental sanitation and hygienic practices. In the developing 

world, nearly all HAV infections occur in childhood and are asymptomatic or cause a 

mild illness. As a result, hepatitis A (symptomatic infection with jaundice) is rarely seen 

in the developing world. More than 90% of adults born in many developing countries are 

seropositive.

Children play an important role in the transmission of HAV and serve as a source of 

infection for others, because most children have asymptomatic infections or mild, 

unrecognized HAV infections. In the United States, the disease is most common among 

school-aged children and young adults. After correction for under-reporting and 

undiagnosed infections, an estimated 61,000 HAV infections (includes cases of hepatitis 

A as well as asymptomatic infections) occurred in 2003.

HAV Immunization: 

Immune globulin (IG) can be used to provide passive pre-exposure immunoprophylaxis 

against hepatitis A. Protection is immediately conferred to an exposed individual 

following administration of IG, and immunity is provided for 3-5 months following 

inoculation. IG is effective in preventing HAV infection when given as post-exposure 

immunoprophylaxis, if given within 14 days of exposure. When a food employee with 

hepatitis A is identified, IG is often given to co-workers. Active immunoprophylaxis using 

hepatitis A vaccine (a formalin-inactivated, attenuated strain of HAV) has been shown to 

provide immunity in > 95% of those immunized, with minimal adverse reactions. 

Hepatitis A vaccination of food employee has been advocated, but has not been shown 

to be cost-effective and generally is not recommended in the United States, although it 

may be appropriate in some communities. 

Incubation period: Average 28-30 days (range 15-50 days).

Symptoms and Complications: 

Illness usually begins with symptoms such as nausea/ vomiting, diarrhea, abdominal 

pain, fever, headache, and/or fatigue. Jaundice, dark urine or light colored stools might 

be present at onset, or follow illness symptoms within a few days. HAV infection of older 

children and adults is more likely to cause clinical illness with jaundice (i.e., hepatitis A); 

onset of illness is usually abrupt. In young adults, 76-97% have symptoms and 40-70% 

are jaundiced. Jaundice generally occurs 5-7 days after the onset of gastrointestinal 

symptoms. For asymptomatic infections, evidence of hepatitis may be detectable only 

through laboratory tests of liver infections such as alanine aminotransferase (ALT) tests. 

The disease varies in severity from a mild illness to a fulminant hepatitis, ranging from 

1-2 weeks to several months in duration. In up to 10-15% of the reported cases, 

prolonged, relapsing hepatitis for up to 6 months occurs. The degree of severity often 

increases with age; however, most cases result in complete recovery, without sequelae 
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 37

or recurrence. The reported case fatality rate is 0.1% - 0.3% and can reach 1.8% for 

adults over 50 years old. 

Diagnosis: 

Diagnosis of HAV infection requires specific serological testing for IgM anti-HAV. IgM 

anti-HAV becomes undetectable within 6 months of illness onset for most persons; 

however, some persons can remain IgM anti-HAV positive for years after acute 

infection. Total anti-HAV (the only other licensed serologic test) can be detected during 

acute infection but remains positive after recovery and for the remainder of the person’s 

life. 

Infectivity: 

The infective dose of HAV is presumed to be low (10 to 100 viral particles), although the 

exact dose is unknown. The viral particles are excreted in the feces of ill people 

(symptomatic and asymptomatic) at high densities (106 to 108/gm) and have been 

demonstrated to be excreted at these levels for up to 36 days post-infection. Evidence 

indicates maximum infectivity during the latter half of the incubation period, continuing 

for a few days after onset of jaundice. Most cases are probably noninfectious after the 

first week of jaundice. Chronic shedding of HAV in feces has not been reported. HAV is 

shed at peak levels in the feces, one to two weeks before onset of symptoms, and 

shedding diminishes rapidly after liver dysfunction or symptoms appear. Liver 

dysfunction or symptoms occur at the same time circulating antibodies to HAV first 

appear. Immunity after infection probably lasts for life; immunity after vaccination is 

estimated to last for at least 20 years. 

Reporting History of Exposure:

The reporting requirements for history of exposure are designed to identify employees 

who may be incubating an infection due to norovirus, Shigella spp., E. coli O157:H7 or 

other STEC, typhoid fever, HAV. 

Which employees who report exposure are restricted? 

• Employees who work in a food establishment serving a highly susceptible 

population (HSP) facility, except those employees who are exposed to 

nontyphoidal Salmonella (NTS). 

Why don’t employees who are exposed to nontyphoidal Salmonella (NTS) need to be 

restricted? 

• For those employees who are exposed to nontyphoidal Salmonella, exposure 

alone does not necessitate restriction of the employee based on 

epidemiologic evidence of no increased risk of employees with only a history 

of exposure versus employees who were infected and diagnosed.

What constitutes exposure? 
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 38

• Consuming a food that caused illness in another consumer due to infection 

with Norovirus, Shigella spp., E. coli O157:H7 or other STEC, typhoid fever, 

or HAV. 

• Attending an event or working in a setting where there is a known disease 

outbreak. 

• Close contact with a household member who is ill and is diagnosed with a 

listed pathogen. 

Why are other guidelines provided, in addition to restriction for employees serving an 

HSP who report exposure to hepatitis A virus?

• Employees who have had a hepatitis A illness in the past are most likely 

protected from infection by life-time immunity to hepatitis A infection.

• Immunity developed through immunization or IgG inoculation prevents 

hepatitis A infection in exposed employees.

• Our standard definition of HSP doesn’t apply very well to HAV. Children under 

6 years old who become infected with HAV are generally asymptomatic, and 

while a higher proportion of susceptible elderly who become infected have 

serious illness, most institutionalized elderly are protected from HAV by prior 

infection. 

What is the period of restriction? 

• The period of restriction begins with the most recent time of foodborne or 

household member exposure and lasts for the usual incubation period of the 

pathogen as defined in the Control of Communicable Diseases Manual. This is 

the time that the employee is most likely to begin shedding the pathogen. 

o For norovirus, 48 hours after the most recent exposure

o For Shigella spp., 3 days after the most recent exposure

o For E. coli O157:H7 or other STEC, 3 days after the most recent 

exposure

o For typhoid fever (S. Typhi), 14 days after the most recent exposure

o For HAV, 30 days after the most recent exposure

What is the period of restriction when exposed to a diagnosed, ill household member? 

• While the household member is symptomatic with an infection due to Norovirus, 

Shigella spp., E coli O157:H7 or other STEC, typhoid fever (S. Typhi) or HAV;

• Plus during the usual incubation period of the pathogen of concern: 

o For norovirus, symptomatic period plus 48 hours

o For Shigella spp., symptomatic period plus 3 days

o For E. coli O157:H7 or other STEC, symptomatic period plus 3 days

o For typhoid fever (S. Typhi), symptomatic period plus 14 days

o For HAV, onset of jaundice plus 30 days

What is the appropriate response to a report of exposure to other food employees? 
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 39

• Employees who report a history of exposure but who do not work in a HSP 

facility should be reminded of the requirements for reporting illness, 

avoidance of bare hand contact with RTE foods, and proper hand washing 

and personal hygiene. 

2-201.12 Exclusions and Restrictions.3

Refer to public health reasons for § 2-201.11 for actions to take with conditional 

employees. 

It is necessary to exclude food employees symptomatic with diarrhea, vomiting, or 

jaundice, or suffering from a disease likely to be transmitted through contamination of 

food, because of the increased risk that the food being prepared will be contaminated 

such as with a pathogenic microorganism. However, if the food employee is suffering 

from vomiting or diarrhea symptoms, and the condition is from a non-infectious 

condition, Crohn’s disease or an illness during early stages of a pregnancy, the risk of 

transmitting a pathogenic microorganism is minimal. In this case, the food employee 

may remain working in a full capacity if they can substantiate that the symptom is from a 

noninfectious condition. The food employee can substantiate this through providing to 

the person in charge medical documentation or other documentation proving that the 

symptom is from a noninfectious condition. 

Because of the high infectivity (ability to invade and multiply) and/ or virulence (ability to 

produce severe disease), of typhoid fever (Salmonella Typhi) and hepatitis A virus, a 

food employee diagnosed with an active case of illness caused by either of these two 

pathogens, whether asymptomatic or symptomatic, must be excluded from food 

establishments. The exclusion is based on the high infectivity, and/or the severe 

medical consequences to individuals infected with these organisms. A food employee 

diagnosed with an active case of illness caused by norovirus, Shigella spp., STEC, or 

nontyphoidal Salmonella (NTS), is excluded if exhibiting symptoms of vomiting and 

diarrhea, and then allowed to work as the level of risk of pathogen transmission 

decreases (See section 2-201.12, Tables #1b, #2 and #3). 

The degree of risk for a food employee or conditional employee who is diagnosed with 

an infection but asymptomatic with regard to symptoms, to transmit a foodborne 

pathogen decreases with the resolution of symptoms. This risk decreases even further 

for those employees that are diagnosed with a listed pathogen, but never developed 

3In order to comply with Title I of the Americans with Disabilities Act, an exclusion must also be removed if the 

employee is entitled to a reasonable accommodation that would eliminate the risk of transmitting the disease. 

Reasonable accommodation may include reassignment to another position in which the individual would not work 

around food. The steps an employer must take when an excluded employee requests reasonable accommodation 

are briefly described in Annex 3, § 2-201.11. However, it is not possible to explain all relevant aspects of the ADA 

within this Annex. When faced with an apparent conflict between ADA and the Food Code’s exclusion and restriction 

requirements, employers should contact the U.S. Equal Employment Opportunity Commission. 
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 40

symptoms. The decrease in risk is taken under consideration when excluding and 

restricting diagnosed food employees and results in a slight difference in the way food 

employees diagnosed with Norovirus, but asymptomatic with respect to gastrointestinal 

symptoms are handled (See section 2-201.12, Table #2).

Restriction of food employees infected with NTS after resolution of symptoms has not 

been a national standard. However, because of the prolonged duration of shedding of 

NTS, evidence that food workers have been the source of foodborne outbreaks, 

evidence that food workers work while ill (Green et al. 2005), and evidence of 

inadequate hand hygiene practices (Green et al. 2006; US FDA 2004), exclusion or 

restriction of infected food worker duties is a reasonable public health measure. At a 

minimum, potential for transmission and how to prevent it should be discussed with the 

food employee and their manager.

There is no epidemiological evidence of an increased risk of NTS transmission from 

food employees in highly susceptible populations over the general population. Current 

evidence suggests that restriction is sufficient in food establishments that serve either 

highly susceptible populations or the non-highly susceptible populations to control 

transmission on NTS. Further, events where an infected food handler is involved in 

nontyphoidal salmonellosis outbreaks in establishments serving highly susceptible 

populations are much less frequent than those in establishments not serving highly 

susceptible populations. For example, from 1998-2011, only 41 nontyphoidal 

salmonellosis outbreaks were reported to CDC that occurred in nursing home facilities 

and 16 outbreaks in hospitals, compared with 731 outbreaks in restaurants or delis. 

There are many highly susceptible persons in the general population who eat in regular, 

non-institutionalized settings. A more restrictive exclusion criteria for establishments 

serving highly susceptible populations is not warranted at this time.

2-201.11 / 2-201.12 Decision Tree 1. When to Exclude or Restrict a 

Food Employee Who Reports a Symptom and When to Exclude a 

Food Employee Who Reports a Diagnosis with Symptoms Under the 

Food Code
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 41

Key: Decision Tree 1

STEC = Shiga toxin-producing Escherichia coli

HSP = Highly Susceptible Population

NTS = Nontyphoidal Salmonella
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 42

2-201.11 / 2-201.12 Decision Tree 2a. When to Exclude or Restrict a 

Food Employee Who is Asymptomatic and Reports a Listed 

Diagnosis Under the Food Code

Key: Decision Tree 2a 

STEC = Shiga toxin-producing Escherichia coli

HSP = Highly Susceptible Population

NTS = Nontyphoidal Salmonella
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 43

2-201.11 / 2-201.12 Decision Tree 2b. When to Restrict a Food 

Employee Who Reports a Listed Exposure Under the Food Code

Key: Decision Tree 2b

STEC = Shiga toxin-producing Escherichia coli

HAV = Hepatitis A virus

HSP = Highly Susceptible Population
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 44

2-201.12 Table 1a: Summary of Requirements for Symptomatic Food 

Employees

Food employees and conditional employees shall report symptoms immediately 

to the person in charge.

The person in charge shall prohibit a conditional employee who reports a listed symptom from 

becoming a food employee until meeting the criteria listed in section 2-201.13 of the Food Code, 

for reinstatement of a symptomatic food employee. 

SYMPTOM

EXCLUSION

OR

RESTRICTION

(FACILITIES 

SERVING AN 

HSP)

EXCLUSION

OR

RESTRICTION

(FACILITIES NOT 

SERVING AN 

HSP)

REMOVING SYMPTOMATIC FOOD 

EMPLOYEES FROM EXCLUSION 

OR RESTRICTION

RA

APPROVAL 

NEEDED TO 

RETURN TO 

WORK?

Vomiting EXCLUDE

2-201.12(A)(1)

EXCLUDE

2-201.12(A)(1)

When the excluded food employee 

has been asymptomatic for at least 

24 hours or provides medical 

documentation 2-201.13(A)(1). 

Exceptions: If diagnosed with 

Norovirus, Shigella spp., STEC, 

HAV, or typhoid fever (S. Typhi) (see 

Tables 1b & 2).

No if not 

diagnosed 

Diarrhea EXCLUDE

2-201.12(A)(1)

EXCLUDE

2-201.12(A)(1)

When the excluded food employee 

has been asymptomatic for at least 

24 hours or provides medical 

documentation 2-201.13(A). 

Exceptions: If Diagnosed with 

Norovirus, STEC, HAV, or S. Typhi

(see Tables 1b & 2).

No if not 

diagnosed

Jaundice EXCLUDE

2-201.12(B)(1) 

if the onset 

occurred within 

the last 7 days

EXCLUDE

2-201.12(B)(1) 

if the onset 

occurred within 

the last 7 days

When approval is obtained from the 

RA 2-201.13 (B), and: 

Food employee has been 

jaundiced for more than 7 

calendar days 2-201.13(B)(1), or 

Food employee provides medical 

documentation 2-201.13(B)(3). 

Yes

Sore Throat 

with Fever

EXCLUDE

2-201.12(G)(1)

RESTRICT

2-201.12(G)(2)

When food employee provides 

written medical documentation 

201.13(G) (1)-(3).

No
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 45

SYMPTOM

EXCLUSION

OR

RESTRICTION

(FACILITIES 

SERVING AN 

HSP)

EXCLUSION

OR

RESTRICTION

(FACILITIES NOT 

SERVING AN 

HSP)

REMOVING SYMPTOMATIC FOOD 

EMPLOYEES FROM EXCLUSION 

OR RESTRICTION

RA

APPROVAL 

NEEDED TO 

RETURN TO 

WORK?

Infected 

wound or 

pustular boil

RESTRICT

2-201.12(I)

RESTRICT

2-201.12(I)

When the infected wound or boil is 

properly covered 2-201.13(I)(1)-(3).

No

Key: Table 1a 

RA = Regulatory Authority

STEC = Shiga toxin-producing Escherichia coli

HAV = Hepatitis A virus

HSP = Highly Susceptible Population
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 46

2-201.12 Table 1b: Summary of Requirements for Diagnosed, 

Symptomatic Food Employees

Food employees and conditional employees shall report a listed Diagnosis with 

symptoms immediately to the person in charge.

The person in charge shall notify the RA when a food employee is jaundiced or reports a listed 

diagnosis

The person in charge shall prohibit a conditional employee who reports a listed diagnosis with 

symptoms from becoming a food employee until meeting the criteria listed in section 2-201.13 of 

the Food Code, for reinstatement of a diagnosed, symptomatic food employee.

DIAGNOSIS

EXCLUSION

(FACILITIES 

SERVING AN 

HSP OR NOT 

SERVING AN 

HSP)

REMOVING DIAGNOSED, SYMPTOMATIC FOOD 

EMPLOYEES FROM EXCLUSION

RA

APPROVAL 

NEEDED 

TO 

RETURN 

TO WORK?

Hepatitis A 

virus

EXCLUDE if 

within 14 days of 

any symptom, or 

within 7 days of 

jaundice

2-201.12(B)(2)

When approval is obtained from the RA

2-201.13(B), and: 

The food employee has been jaundiced for more 

than 7 calendar days 2-201.13(B)(1), or 

The anicteric food employee has had symptoms 

for more than 14 days 2-201.13(B)(2), or

The food employee provides medical 

documentation 2-201.13(B)(3) (also see 

Table 2).

Yes 

Typhoid Fever 

(S. Typhi) 

EXCLUDE

2-201.12(C)

When approval is obtained from the RA

2-201.13(C)(1), and: 

Food employee provides medical documentation, 

that states the food employee is free of a S. 

Typhi infection 2-201.13(C)(2) (also see 

Table 2).

Yes

Nontyphoidal 

Salmonella

EXCLUDE

Based on 

vomiting or 

diarrhea 

symptoms, under 

2-201.12(A)(2)

When approval is obtained from the RA

2-201.13(G), and: 

Food employee provides medical documentation, 

that states the food employee is free of a 

nontyphoidal Salmonella infection 

2-201.13)(G)(1) or 

Yes
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 47

DIAGNOSIS

EXCLUSION

(FACILITIES 

SERVING AN 

HSP OR NOT 

SERVING AN 

HSP)

REMOVING DIAGNOSED, SYMPTOMATIC FOOD 

EMPLOYEES FROM EXCLUSION

RA

APPROVAL 

NEEDED 

TO 

RETURN 

TO WORK?

Food employee symptoms of vomiting or diarrhea 

resolved and >30 days have passed since the 

food employee became asymptomatic (2-

201.13(G)(2)). 

STEC EXCLUDE

Based on 

vomiting or 

diarrhea 

symptoms, under 

2-201.12(A)(2)

1. Serving a non-HSP facility: 2-201.13(A)(4)(a): 

Shall only work on a restricted basis 24 hours 

after symptoms resolve and remains restricted 

until meeting the requirements listed in No. 3. 

2. Serving an HSP facility: 2-201.13(A)(4)(b): 

Remains excluded until meeting the 

requirements listed in No. 3. 

3. Restriction or Exclusion remains until:

Approval is obtained from RA 2-201.13(F), and

Medically cleared 2-201.13(F)(1), or

More than 7 calendar days have passed since the 

food employee became asymptomatic 

2-201.13(F)(2) (also see Table 2). 

Yes to 

return to an 

HSP or to 

return 

unrestricted; 

not required 

to work on a 

restricted 

basis in a 

non-HSP 

facility

Norovirus EXCLUDE

Based on 

vomiting or 

diarrhea 

symptoms, under 

2-201.12(A)(2)

1. Serving a non-HSP facility: 2-201.13 (A)(2)(a): 

Shall only work on a restricted basis 24 hours 

after symptoms resolve and remains restricted 

until meeting the requirements listed in No. 3. 

2. Serving an HSP facility: 2-201.13(A)(2)(b): 

Remains excluded until meeting the 

requirements listed in No. 3. 

3. Restriction or Exclusion remains until:

Approval is obtained from the RA 2-201.13(D), 

and

Medically cleared 2-201.13(D)(1), or 

More than 48 hours have passed since the food 

employee became asymptomatic 

2-201.13(D)(2) (also see Table 2). 

Yes to 

return to an 

HSP or to 

return 

unrestricted; 

not required 

to work on a 

restricted 

basis in a 

non-HSP 

facility
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 48

DIAGNOSIS

EXCLUSION

(FACILITIES 

SERVING AN 

HSP OR NOT 

SERVING AN 

HSP)

REMOVING DIAGNOSED, SYMPTOMATIC FOOD 

EMPLOYEES FROM EXCLUSION

RA

APPROVAL 

NEEDED 

TO 

RETURN 

TO WORK?

Shigella spp. EXCLUDE

Based on 

vomiting or 

diarrhea 

symptoms, 

under 

2-201.12(A)(2)

1. Serving a non-HSP facility: 2-201.13(A)(3)(a): 

Shall only work on a restricted basis 24 hours 

after symptoms resolve, and remains restricted 

until meeting the requirements listed in No. 3. 

2. Serving an HSP facility: 2-201.13(A)(3)(b): 

Remains excluded until meeting the 

requirements in No. 3.

3. Restriction or Exclusion remains until:

Approval is obtained from the RA 2-201.13(E), 

and

Medically cleared 2-201.13(E)(1), or

More than 7 calendar days have passed since the 

food employee became asymptomatic 2-

201.13(E)(2) (also see Table 2).

Yes to 

return to an 

HSP or to 

return 

unrestricted; 

not required 

to work on a 

restricted 

basis in a 

non-HSP 

facility

Key: Table 1b 

RA = Regulatory Authority

STEC = Shiga toxin-producing Escherichia coli

HAV = Hepatitis A virus

HSP = Highly Susceptible Population

NTS = Nontyphoidal Salmonella
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 49

2-201.12 Table 2: Summary of Requirements for Diagnosed Food 

Employees with Resolved Symptoms

Food employees and conditional employees shall report a listed diagnosis 

immediately to the person in charge.

The person in charge shall notify the RA when a food employee reports a listed diagnosis

The person in charge shall prohibit a conditional employee who reports a listed diagnosis from 

becoming a food employee until meeting the criteria listed in section 2-201.13 of the Food Code, 

for reinstatement of a diagnosed food employee. 

Pathogen

Diagnosis

EXCLUSION

OR

RESTRICTION

(Facilities 

Serving an 

HSP)

EXCLUSION

OR

RESTRICTION

(Facilities Not 

Serving an 

HSP)

Removing Diagnosed 

Food Employees with 

Resolved Symptoms 

from Exclusion or 

Restriction

RA 

Approval 

Required to 

Return to 

Work?

Typhoid fever 

(S. Typhi) 

including 

previous 

illness with S.

Typhi (see 

2-201.11

(A)(3))

EXCLUDE

2-201.12(C)

EXCLUDE

2-201.12(C)

When approval is obtained 

from the RA 2-201.13(C)(1), 

and: 

Food employee provides 

medical documentation that 

states the food employee is 

free of an S. Typhi infection 

2-201.13)(C)(2) (also see 

Table 1b). 

Yes

Nontyphoidal 

Salmonella RESTRICT

2-201.12(G)

RESTRICT

2-201.12(G)

When approval is obtained 

from the RA 2-201.13(G), 

and: 

Food employee provides 

medical documentation, 

that states the food 

employee is free of a 

nontyphoidal Salmonella 

infection 2-201.13)(G)(1) 

or 

Food employee symptoms 

of vomiting or diarrhea 

resolved and >30 days 

have passed since the 

food employee became 

asymptomatic

(2-201.13(G)(2)). 

Yes

Shigella spp. EXCLUDE

2-201.12(E)(1)

RESTRICT

2-201.12(E)(2)

1. Serving a non-HSP 

facility: 

2-201.13(A)(3)(a): Shall 

Yes to return to 

an HSP or to 

return 
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 50

Pathogen

Diagnosis

EXCLUSION

OR

RESTRICTION

(Facilities 

Serving an 

HSP)

EXCLUSION

OR

RESTRICTION

(Facilities Not 

Serving an 

HSP)

Removing Diagnosed 

Food Employees with 

Resolved Symptoms 

from Exclusion or 

Restriction

RA 

Approval 

Required to 

Return to 

Work?

only work on a restricted 

basis 24 hours after 

symptoms resolve, and 

remains restricted until 

meeting the 

requirements listed in 

No. 3. 

2. Serving an HSP facility: 

2-201.13(A)(3)(b): 

Remains excluded until 

meeting the 

requirements listed in 

No. 3. 

3. Restriction or Exclusion 

remains until:

Approval is obtained from 

the RA 2-201.13(E), 

and: 

Medically cleared 

2-201.13(E)(1), or 

More than 7 calendar days 

have passed since the 

food employee became 

asymptomatic 

201.13(E)(3)(a) (also 

see Table 1b). 

unrestricted; 

not required to 

work on a 

restricted basis 

in a non-HSP 

facility

Norovirus

EXCLUDE

2-201.12(D)(1)

RESTRICT

2-201.12(D)(2)

1. Serving a non-HSP 

facility: 

2-201.13(A)(2)(a): Shall 

only work on a restricted 

basis 24 hours after 

symptoms resolve and 

remains restricted until 

meeting the 

requirements listed in 

No. 3. 

2. Serving an HSP facility: 

2-201.13(A)(2)(b): 

Remains excluded until 

meeting the 

requirements listed in 

Yes to return to 

an HSP or to 

return 

unrestricted; 

not required to 

work on a 

restricted basis 

in a non-HSP 

facility
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 51

Pathogen

Diagnosis

EXCLUSION

OR

RESTRICTION

(Facilities 

Serving an 

HSP)

EXCLUSION

OR

RESTRICTION

(Facilities Not 

Serving an 

HSP)

Removing Diagnosed 

Food Employees with 

Resolved Symptoms 

from Exclusion or 

Restriction

RA 

Approval 

Required to 

Return to 

Work?

No. 3. 

3. Restriction or Exclusion 

remains until:

Approval is obtained from 

the RA 2-201.13(D), and 

Medically cleared 

2-201.13(D)(1), or 

More than 48 hours have 

passed since the food 

employee became 

asymptomatic 

2-201.13(D)(2) (also see 

Table 1b). 

STEC

EXCLUDE

2-201.12(F)(1)

RESTRICT

2-201.12(F)(2)

1. Serving a non-HSP 

facility: 

2-201.13(A)(4)(a): Shall 

only work on a restricted 

basis 24 hours after 

symptoms resolve and 

remains restricted until 

meeting the 

requirements listed in 

No. 3. 

2. Serving an HSP facility: 

201.13(A)(4)(b): 

Remains excluded until 

meeting the 

requirements listed in 

No. 3. 

3. Restriction or Exclusion 

remains until: 

Approval is obtained from 

the RA 2-201.13(F), and

Medically cleared 

2-201.13(F)(1), or 

More than 7 calendar days 

have passed since the 

food employee became 

asymptomatic 

2-201.13(F)(2). 

Yes to return to 

an HSP or to 

return 

unrestricted; 

not required to 

work on a 

restricted basis 

in a non-HSP 

facility
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 52

Pathogen

Diagnosis

EXCLUSION

OR

RESTRICTION

(Facilities 

Serving an 

HSP)

EXCLUSION

OR

RESTRICTION

(Facilities Not 

Serving an 

HSP)

Removing Diagnosed 

Food Employees with 

Resolved Symptoms 

from Exclusion or 

Restriction

RA 

Approval 

Required to 

Return to 

Work?

Hepatitis A 

virus EXCLUDE if 

within 14 days 

of any 

symptom, or 

within 7 days 

of jaundice

2-201.12(B)(2)

EXCLUDE if 

within 14 

days of any 

symptom, or 

within 7 days 

of jaundice

2-201.12(B)(2)

When approval is obtained 

from the RA 2-201.13(B), 

and: 

The food employee has 

been jaundiced for more 

than 7 calendar days 

2-201.13(B)(1), or 

The anicteric food 

employee has had 

symptoms for more than 

14 days 2-201.13(B)(2), 

or

The food employee 

provides medical 

documentation 

2-201.13(B)(3) (see also 

Table 1b). 

Yes

Key: Table 2 

RA = Regulatory Authority

STEC = Shiga toxin-producing Escherichia coli

HAV = Hepatitis A virus

HSP = Highly Susceptible Population

NTS = Nontyphoidal Salmonella
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 53

2-201.12 Table 3: Summary of Requirements for Diagnosed Food 

Employees Who Never Develop Gastrointestinal Symptoms

Food employees and conditional employees shall report a listed diagnosis immediately 

to the person in charge

The person in charge shall notify the RA when a food employee reports a listed diagnosis.

The person in charge shall prohibit a conditional employee who reports a listed diagnosis from 

becoming a food employee until meeting the criteria listed in section 2-201.13 of the Food Code, 

for reinstatement of a diagnosed food employee.

Pathogen

Diagnosis

EXCLUSION 

OR 

RESTRICTION

(Facilities 

Serving an 

HSP)

EXCLUSION 

OR 

RESTRICTION

(Facilities Not 

Serving an 

HSP)

Removing Diagnosed Food 

Employees Who Never 

Develop Gastrointestinal 

Symptoms from Exclusion or 

Restriction

RA Approval 

Required to 

Return to 

Work?

Typhoid 

Fever 

(S. Typhi) 

including 

previous 

illness with 

S. Typhi

(see 

2-201.11 

(A)(3))

EXCLUDE

2-201.12(C)

EXCLUDE

2-201.12(C)

When approval is obtained from the 

RA 2-201.13(C)(1), and: 

Food employee provides medical 

documentation, specifying that the 

food employee is free of a S. Typhi

infection 2-201.13(C)(2).

Yes

Shigella

spp.

EXCLUDE

2-201.12(E)(1)

RESTRICT

2-201.12(E)(2)

Remains excluded or restricted until 

approval is obtained from the RA, 

and: 

• Medically cleared 2-

201.13(E)(1), or 

More than 7 calendar days have 

passed since the food 

employee was last diagnosed 

2-201.13(E)(3). 

Yes to return 

to an HSP or 

to return 

unrestricted; 

not required to 

work on a 

restricted 

basis in a nonHSP facility
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 54

Pathogen

Diagnosis

EXCLUSION 

OR 

RESTRICTION

(Facilities 

Serving an 

HSP)

EXCLUSION 

OR 

RESTRICTION

(Facilities Not 

Serving an 

HSP)

Removing Diagnosed Food 

Employees Who Never 

Develop Gastrointestinal 

Symptoms from Exclusion or 

Restriction

RA Approval 

Required to 

Return to 

Work?

Nontyphoidal 

Salmonella

RESTRICT 

2-201.12(G)

RESTRICT 

2-201.12(G)

When approval is obtained from the 

RA 2-201.13(G), and: 

• Food employee provides 

medical documentation, that 

states the food employee is free 

of a nontyphoidal Salmonella 

infection 2-201.13)(G)(1) or 

• Food employee did not develop 

symptoms and >30 days have 

passed since the food 

employee was diagnosed (2-

201.13(G)(3)). 

Yes

Norovirus EXCLUDE

2-201.12(D)(1)

RESTRICT 

2-201.12(D)(2)

Remains excluded or restricted until 

approval is obtained from the RA 

2-201.13(D), and 

• Medically cleared 2-

201.13(D)(1), or 

• More than 48 hours have 

passed since the food 

employee was diagnosed 2-

201.13(D)(3). 

Yes to return 

to an HSP or 

to return 

unrestricted; 

Not required 

to work on a 

restricted 

basis in a nonHSP facility

STEC EXCLUDE

2-201.12(F)(1)

RESTRICT

2-201.12(F)(2)

Remains excluded or restricted until 

approval is obtained from the RA 

2-201.13(F), and: 

Medically cleared 2-201.13(F)(1), 

or 

More than 7 calendar days have 

passed since the food employee 

was diagnosed 2-201.13(F)(3). 

Yes to return 

to HSP or to 

return 

unrestricted; 

Not required 

to work on a 

restricted 

basis in a nonHSP facility
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 55

Pathogen

Diagnosis

EXCLUSION 

OR 

RESTRICTION

(Facilities 

Serving an 

HSP)

EXCLUSION 

OR 

RESTRICTION

(Facilities Not 

Serving an 

HSP)

Removing Diagnosed Food 

Employees Who Never 

Develop Gastrointestinal 

Symptoms from Exclusion or 

Restriction

RA Approval 

Required to 

Return to 

Work?

Hepatitis A 

virus

EXCLUDE

2-201.12(B)(3)

EXCLUDE

2-201.12(B)(3)

When approval is obtained from the 

RA 2-201.13(B), and 

• The anicteric food employee 

has had symptoms for more 

than 14 days 2-201.13(B)(2), or

• The food employee provides 

medical documentation 

2-201.13(B)(3). 

Yes

RA = Regulatory Authority

STEC = Shiga toxin-producing Escherichia coli

HAV = Hepatitis A virus

HSP = Highly Susceptible Population

NTS = Nontyphoidal Salmonella
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 56

2-201.12 Table 4: History of Exposure, and Absent Symptoms or 

Diagnosis

Food employees and conditional employees shall report a listed exposure to the 

person in charge

The person in charge shall prohibit a conditional employee who reports a listed exposure from 

becoming a food employee in a facility serving an HSP until meeting the criteria listed in section 

2-201.13 of the Food Code, for reinstatement of an exposed food employee

The person in charge shall reinforce and ensure compliance with good hygienic 

practices, symptom reporting requirements, proper handwashing and no BHC with RTE 

foods for all food employees that report a listed exposure.

PATHOGEN 

DIAGNOSIS

EXCLUSION

OR

RESTRICTION

(FACILITIES 

SERVING AN 

HSP)

FACILITIES NOT 

SERVING AN HSP

WHEN CAN THE 

RESTRICTED FOOD 

EMPLOYEE RETURN TO 

WORK?

RA

APPROVAL 

NEEDED?

Typhoid 

Fever 

(S. Typhi)

RESTRICT

2-201.12(I)

Educate food employee 

on symptoms to watch 

for and ensure 

compliance with GHP, 

handwashing and no 

BHC with RTE foods.

2-201.13(I)(3)

When 14 calendar days have 

passed since the last exposure, 

or more than 14 days has 

passed since the food 

employee’s household contact 

became asymptomatic.

No

Shigella 

spp.

RESTRICT

2-201.12(I)

Educate food employee 

on symptoms to watch 

for and ensure 

compliance with GHP, 

handwashing and no 

BHC with RTE foods.

2-201.13(I)(2)

When more than 3 calendar 

days have passed since the last 

exposure, or more than 3 days 

have passed since the food 

employee’s household contact 

became asymptomatic. 

No

Norovirus RESTRICT

2-201.12(I)

Educate food employee 

on symptoms to watch 

for and ensure 

compliance with GHP, 

handwashing and no 

BHC with RTE foods.

2-201.13(I)(1)

When more than 48 hours have 

passed since the last exposure, 

or more than 48 hours has 

passed since the food 

employee’s household contact 

became asymptomatic. 

No

STEC RESTRICT

2-201.12(I)

Educate food employee 

on symptoms to watch 

for and ensure 

compliance with GHP, 

2-201.13(I)(2)

When more than 3 calendar 

days have passed since the last 

No
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 57

PATHOGEN 

DIAGNOSIS

EXCLUSION

OR

RESTRICTION

(FACILITIES 

SERVING AN 

HSP)

FACILITIES NOT 

SERVING AN HSP

WHEN CAN THE 

RESTRICTED FOOD 

EMPLOYEE RETURN TO 

WORK?

RA

APPROVAL 

NEEDED?

handwashing and no 

BHC with RTE foods.

exposure, or more than 3 

calendar days has passed 

since the food employee’s 

household contact became 

asymptomatic. 

Hepatitis A 

virus

RESTRICT

2-201.12(I)

Educate food employee 

on symptoms to watch 

for and ensure 

compliance with GHP, 

handwashing and no 

BHC with RTE foods.

2-201.13(I)(2)

When any of the following 

conditions is met:

• The food employee is 

immune to HAV 

infection because of a 

prior illness from HAV, 

vaccination against 

HAV, or IgG 

administration; or

• More than 30 calendar 

days have passed 

since the last 

exposure, or since the 

food employee’s 

household contact 

became jaundiced; or

• The food employee 

does not use an 

alternative procedure 

that allows BHC with 

RTE food until at least 

30 days after the 

potential exposure, 

and the employee 

receives additional 

training. 

No

(continued)

Key: Table 4

HSP = Highly Susceptible Population

BHC = Bare Hand Contact

RTE = Ready-To-Eat

GHP = Good Manufacturing Practices

STEC = Shiga toxin-producing Escherichia coli
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 58

2-201.12 Exclusion and Restrictions (continued)4

Restrictions and exclusions vary according to the population served because highly 

susceptible populations have increased vulnerability to foodborne illness. For example, 

foodborne illness in a healthy individual may be manifested by mild flu-like symptoms. 

The same foodborne illness may have serious medical consequences in 

immunocompromised individuals. This point is reinforced by statistics pertaining to 

deaths associated with foodborne illness caused by Salmonella Enteritidis. Over 70% 

of the deaths in outbreaks attributed to this organism occurred among individuals who 

for one reason or another were immunocompromised. This is why the restrictions and 

exclusions listed in the Code are especially stringent for food employees serving highly 

susceptible populations. 

Periodic testing of food employees for the presence of diseases transmissible through 

food is not cost effective or reliable. Therefore, restriction and exclusion provisions are 

triggered by the active gastrointestinal symptoms, followed by diagnosis and history of 

exposure. 

The history of exposure that must be reported applies to Norovirus, Hepatitis A, Shigella

spp., STEC and Salmonella Typhi. It does not include nontyphoidal Salmonella. 

Upon being notified of the history of exposure, the person in charge should immediately: 

1. Discuss the traditional modes of transmission of fecal-oral route 

pathogens. 

2. Advise the food employee to observe good hygienic practices both at 

home and at work. This includes a discussion of proper handwashing, as 

described in the Code, after going to the bathroom, changing diapers, or 

handling stool-soiled material. 

3. Review the symptoms listed in the Code that require immediate exclusion 

from the food establishment. 

4. Remind food employees of their responsibility as specified in the Code to 

inform the person in charge immediately upon the onset of any of the 

symptoms listed in the Code.

4In order to comply with Title I of the Americans with Disabilities Act, an exclusion must also be removed if the 

employee is entitled to a reasonable accommodation that would eliminate the risk of transmitting the disease.

Reasonable accommodation may include reassignment to another position in which the individual would not work 

around food. The steps an employer must take when an excluded employee requests reasonable accommodation 

are briefly described in Annex 3, § 2-201.11. However, it is not possible to explain all relevant aspects of the ADA 

within this Annex. When faced with an apparent conflict between the ADA and the Food Code’s exclusion and 

restriction requirements, employers should contact the U.S. Equal Employment Opportunity Commission.
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 59

5. Ensure that the food employee stops work immediately if any of the 

symptoms described in the Code develop and reports to the person in 

charge. 

A restricted food employee may work in an area of the food establishment that houses 

packaged food, wrapped single-service or single-use articles, or soiled food equipment 

or utensils. Examples of activities that a restricted person might do include working at 

the cash register, seating patrons, bussing tables, stocking canned or other packaged 

foods, or working in a non-food cleaning or maintenance capacity consistent with the 

criteria in the definition of the term “restricted.” A food employee who is restricted from 

working in one food establishment may not work in an unrestricted capacity in another 

food establishment, but could work unrestricted in another retail store that is not a food 

establishment. A restricted food employee may enter a food establishment as a 

consumer. 

An excluded individual may not work as a food employee on the premises of any food 

establishment. 

2-201.13 Removal of Exclusions and Restrictions.5

Food employees diagnosed with Norovirus, hepatitis A virus, Shigella spp., E. coli 

O157:H7 or other STEC, nontyphoidal Salmonella and symptomatic with diarrhea, 

vomiting, or jaundice, are excluded under subparagraph 2-201.12 (A)(2) or 2-

201.12(B)(2). However these symptomatic, diagnosed food employees differ from 

symptomatic, undiagnosed food employees in the requirements that must be met before 

returning to work in a full capacity after symptoms resolve. 

The person in charge may allow undiagnosed food employees who are initially 

symptomatic and whose symptoms have resolved to return to work in a full capacity 

24 hours after symptoms resolve. 

However, diagnosis with a listed pathogen invokes additional requirements before the 

person in charge may allow diagnosed food employees to return to work in full capacity. 

Asymptomatic food employees diagnosed with Norovirus, Shigella spp., E. coli 

O157:H7 or other STEC may not return to work in a full capacity for at least 24 hours 

after symptoms resolve. The person in charge shall only allow these food employees to 

work on a restricted basis 24 hours after symptoms resolve and they shall only allow 

5In order to comply with Title I of the Americans with Disabilities Act, an exclusion must also be removed if the 

employee is entitled to a reasonable accommodation that would eliminate the risk of transmitting the disease.

Reasonable accommodation may include reassignment to another position in which the individual would not work 

around food. The steps an employer must take when an excluded employee requests reasonable accommodation 

are briefly described in Annex 3, § 2-201.11. However, it is not possible to explain all relevant aspects of the ADA 

within this Annex. When faced with an apparent conflict between the ADA and the Food Code’s exclusion and 

restriction requirements, employers should contact the U.S. Equal Employment Opportunity Commission.
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 60

this if not in a food establishment that serves a highly susceptible population. These 

restricted food employees remain restricted until they are medically cleared or otherwise 

meet the criteria for removal from restriction as specified under subparagraphs 

2-201.13(D) (1)-(2); 2-201.13(E)(1)-(2); or 2-201.13(F)(1)-(2). 

In a food establishment that serves a highly susceptible population, food employees 

who are diagnosed with Norovirus, Shigella spp., E. coli O157:H7 or other STEC and 

initially symptomatic with vomiting or diarrhea, shall not work on a restricted basis after 

being asymptomatic for at least 24 hours. These food employees must remain excluded 

until they are medically cleared or otherwise meet the criteria for removal from exclusion 

from a highly susceptible population under subparagraph 2-201.13(D)(1)-(2), 

2-201.13(E)(1)-(2), or 2-201.13 (F)(1)-(2). 

Food employees diagnosed with hepatitis A virus are always excluded if diagnosed 

within 14 days of exhibiting any illness symptom, until at least 7 days after the onset of 

jaundice, or until medically cleared as specified under subparagraphs 

2-201.13(B)(1)-(4). 

Food employees diagnosed with hepatitis A virus are always excluded if diagnosed 

within 14 days of exhibiting any illness symptom, until at least 7 days after the onset of 

jaundice, or until medically cleared as specified under subparagraphs 

2-201.13(B)(1)-(3). A food employee with an anicteric infection with the hepatitis A virus 

has a mild form of hepatitis A without jaundice. Food employees diagnosed with an 

anicteric infection with the hepatitis A virus are excluded if they are within 14 days of 

any symptoms. Anicteric, diagnosed food employees shall be removed from exclusion if 

more than 14 days have passed since they became symptomatic, or if medically 

cleared. Asymptomatic food employees diagnosed with an active infection with the 

hepatitis A virus are also excluded until medically cleared.

Food employees diagnosed with typhoid fever (caused by a Salmonella Typhi 

infection) are always excluded, even without expressing gastrointestinal symptoms, 

since these symptoms are not typically exhibited with typhoid fever. Outbreaks of 

foodborne illness involving typhoid fever (Salmonella Typhi) have been traced to 

asymptomatic food employees who have transmitted the pathogen to food, causing 

illness. The high virulence combined with the extremely high infectivity of S. Typhi

warrant exclusion from the food establishment until the food employee has been cleared 

by a physician or has completed antibiotic therapy. 

Asymptomatic shedders are food employees who do not exhibit the symptoms of 

foodborne illness but who are identified through diagnosis, or laboratory confirmation of 

their stools to have Norovirus, or any one of the four bacterial pathogens identified in 

Chapter 2 in their gastrointestinal system.

The risk that food employees who are asymptomatic shedders will transmit a 

communicable disease varies depending upon the hygienic habits of the worker, the 

food itself and how it is prepared, the susceptibility of the population served, and the 

infectivity of the organism. Exclusion in a food establishment that serves a highly 

susceptible population affords protection to people who are immune-suppressed. 
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 61

Restriction in a food establishment that does not serve a highly susceptible population 

affords protection for the general population and the immune-suppressed subset of the 

general population provided there is adequate attention to personal hygiene and 

avoidance of bare-hand contact with RTE foods. 

To minimize the risk in all food establishments of the transmission of foodborne disease 

by an asymptomatic shedder and based on the factors listed above, all known 

asymptomatic shedders of the four bacterial pathogens are either restricted or excluded, 

depending on the population served. Requiring restriction for asymptomatic shedders of 

all three of the bacterial pathogens results in a uniform criterion and is consistent with 

APHA-published recommendations in the "Control of Communicable Diseases Manual." 

Hands and arms

2-301.11 Clean Condition. 

The hands are particularly important in transmitting foodborne pathogens. Food 

employees with dirty hands and/or fingernails may contaminate the food being 

prepared. Therefore, any activity which may contaminate the hands must be followed by 

thorough handwashing in accordance with the procedures outlined in the Code. 

Even seemingly healthy employees may serve as reservoirs for pathogenic 

microorganisms that are transmissible through food. Staphylococci, for example, can be 

found on the skin and in the mouth, throat, and nose of many employees. The hands of 

employees can be contaminated by touching their nose or other body parts.

2-301.12 Cleaning Procedure.

Handwashing is a critical factor in reducing fecal-oral pathogens that can be transmitted 

from hands to RTE food as well as other pathogens that can be transmitted from 

environmental sources. Many employees fail to wash their hands as often as necessary 

and even those who do may use flawed techniques. 

In the case of a food worker with one hand or a hand-like prosthesis, the Equal 

Employment Opportunity Commission has agreed that this requirement for thorough 

handwashing can be met through reasonable accommodation in accordance with the 

Americans with Disabilities Act. Devices are available which can be attached to a 

lavatory to enable the food worker with one hand to adequately generate the necessary 

friction to achieve the intent of this requirement. 

The greatest concentration of microbes exists around and under the fingernails of the 

hands. The area under the fingernails, known as the “subungal space”, has by far the 

largest concentration of microbes on the hand and this is also the most difficult area of 

the hand to decontaminate. Fingernail brushes, if used properly, have been found to be 

effective tools in decontaminating this area of the hand. Proper use of single-use 

fingernail brushes, or designated individual fingernail brushes for each employee, during 

the handwashing procedure can achieve up to a 5-log reduction in microorganisms on 

the hands. 
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 62

There are two different types of microbes on the hands, transient and resident 

microbes. Transient microbes consist of contaminating pathogens which are loosely 

attached to the skin surface and do not survive or multiply. A moderate number of these 

organisms can be removed with adequate handwashing. Resident microbes consist of a 

relatively stable population that survive and multiply on the skin and they are not easily 

washed off the hands. Resident microbes on the hands are usually not a concern for 

potential contamination in food service. 

All aspects of proper handwashing are important in reducing microbial transients on the 

hands. However, friction and water have been found to play the most important role. 

This is why the amount of time spent scrubbing the hands is critical in proper 

handwashing. It takes more than just the use of soap and running water to remove the 

transient pathogens that may be present. It is the abrasive action obtained by 

vigorously rubbing the surfaces being cleaned that loosens the transient 

microorganisms on the hands. 

Research has shown a minimum 10-15 second scrub is necessary to remove transient 

pathogens from the hands and when an antimicrobial soap is used, a minimum of 15 

seconds is required. Soap is important for the surfactant effect in removing soil from the 

hands and a warm water temperature is important in achieving the maximum surfactant 

effect of the soap.

Every stage in handwashing is equally important and has an additive effect in transient 

microbial reduction. Therefore, effective handwashing must include scrubbing, rinsing, 

and drying the hands. When done properly, each stage of handwashing further 

decreases the transient microbial load on the hands. It is equally important to avoid 

recontaminating hands by avoiding direct hand contact with heavily contaminated 

environmental sources, such as manually operated handwashing sink faucets, paper 

towel dispensers, and rest room door handles after the handwashing procedure. This 

can be accomplished by obtaining a paper towel from its dispenser before the 

handwashing procedure, then, after handwashing, using the paper towel to operate the 

hand sink faucet handles and restroom door handles. 

Handwashing done properly can result in a 2-3 log reduction in transient bacteria and a 

2-log reduction in transient viruses and protozoa. With heavy contamination of transient 

microbial pathogens, (i.e., > 104 microbes, as found on hands contaminated with bodily 

wastes and infected bodily fluids) handwashing may be ineffective in completely 

decontaminating the hands. Therefore, a further intervention such as a barrier between 

hands and ready-to-eat food is necessary. 

2-301.13 Special Handwash Procedures.

This section is reserved. 

In earlier editions of the Code, FDA's model contained a provision for a Special 

Procedure in certain situations. Pursuant to a 1996 Conference for Food Protection 

(CFP) Recommendation, the text of this Code provision is removed and the section is 
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 63

reserved. It is FDA's intent to further research the matter and to submit the findings to 

the CFP for reconsideration of the matter. 

2-301.14 When to Wash. 

The hands may become contaminated when the food employee engages in specific 

activities. The increased risk of contamination requires handwashing immediately 

before, during, or after the activities listed. The specific examples listed in this Code 

section are not intended to be all inclusive. The term “tobacco products” was added to

the 2022 Full Edition of the Food Code to address and include vaping and similar 

activities as another example of when to wash (refer to §1-201.10 public health reasons 

under defined term “tobacoo products” for specific information). Employees must wash 

their hands after any activity which may result in contamination of the hands.

2-301.15 Where to Wash.

Effective handwashing is essential for minimizing the likelihood of the hands becoming 

a vehicle of cross contamination. It is important that handwashing be done only at a 

properly equipped handwashing facility in order to help ensure that food employees 

effectively clean their hands. Handwashing sinks are to be conveniently located, always 

accessible for handwashing, maintained so they provide proper water temperatures and 

pressure, and equipped with suitable hand cleansers, nail brushes, and disposable 

towels and waste containers, or hand dryers. It is inappropriate to wash hands in a food 

preparation sink since this may result in avoidable contamination of the sink and the 

food prepared therein. Service sinks may not be used for food employee handwashing 

since this practice may introduce additional hand contaminants because these sinks 

may be used for the disposal of mop water, toxic chemicals, and a variety of other liquid 

wastes. Such wastes may contain pathogens from cleaning the floors of food 

preparation areas and toilet rooms and discharges from ill persons.

2-301.16 Hand Antiseptics. 

In the 2005 Food Code, the use of the term “hand sanitizer” was replaced by the term 

“hand antiseptic” to eliminate confusion with the term “sanitizer,” a defined term in the 

Food Code, and to more closely reflect the terminology used in the FDA Tentative Final 

Monograph for Health-Care Antiseptic Drug Products for OTC Human Use, Federal 

Register: June 17, 1994. 

The term “sanitizer” is typically used to describe control of bacterial contamination of 

inert objects or articles, or equipment and utensils, and other cleaned food-contact 

surfaces. The Food Code definition of “sanitizer” requires a minimum microbial 

reduction of 5 logs, which is equal to a 99.999% reduction. The FDA bases the 5-log 

reduction on the AOAC International’s “Official Methods of Analysis 2003,” which 

requires a minimum 5-log reduction in microorganisms to achieve “sanitization.”

Sanitizers used to disinfect food-contact equipment and utensils can easily achieve the 

5-log reduction of microorganisms and often far exceed this minimum requirement. 

However, removing microorganisms from human skin is a totally different process and 
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 64

sterilization of human skin is nearly impossible to achieve without damaging the skin. 

Many antimicrobial hand agents typically achieve a much smaller reduction in 

microorganisms than the 5-log reduction required for “sanitization.” Therefore, the effect 

achieved from using antimicrobial hand agents is not consistent with the definition of 

“sanitization” in the Food Code. 

The word “antiseptic” is a Greek term, meaning “against putrefaction”, and eventually 

evolved into a second definition, meaning, “a substance used to destroy pathogenic 

microorganisms.” The term “antiseptic” is often used to describe agents used on skin to 

prevent infection of the skin. 

“Antiseptic” is defined under section 201 (o) of the Federal Food, Drug, and Cosmetic 

Act (the act) (21 U.S.C. 321 (o)), as: “The representation of a drug, in its labeling, as an 

antiseptic shall be considered to be a representation of a germicide, except in the case 

of a drug purporting to be, or represented as, an antiseptic for inhibitory use as a wet 

dressing, ointment, dusting powder, or such other use as involves prolonged contact 

with the body.” 

Section 333.403 of the FDA Tentative Final Monograph for Health-Care Antiseptic Drug 

Products for OTC Human Use, Federal Register: June 17, 1994, defines a “health-care 

antiseptic” as an antiseptic-containing drug product applied topically to the skin to help 

prevent infection or to help prevent cross contamination. An “antiseptic handwash” or 

“health-care personnel handwash drug product” is defined in Section 333.403 of the 

Monograph as an antiseptic containing preparation designed for frequent use; it reduces 

the number of transient microorganisms on intact skin to an initial baseline level after 

adequate washing, rinsing, and drying; it is a broad spectrum, and persistent antiseptic 

containing preparation that significantly reduces the number of microorganisms on intact 

skin. 

Replacing the term “hand sanitizer” with the term “hand antiseptic” allows the use of a 

more scientifically appropriate term that is used to describe reduction of microorganisms 

on the skin and will improve clarification and regulation of these products. 

The provisions of § 2-301.16 are intended to ensure that an antimicrobial product 

applied to the hands is 1) safe and effective when applied to human skin, and 2) a safe 

food additive when applied to bare hands that will come into direct contact with food. 

Because of the need to protect workers and to ensure safe food, hand antiseptics must 

comply with both the human drug and the food safety provisions of the law. The 

prohibition against bare hand contact contained in ¶ 3-301.11(B) applies only to an 

exposed ready-to-eat food. 

As a Drug Product

There are two means by which a hand antiseptic is considered to be safe and effective 

when applied to human skin: 

1. A hand antiseptic may be approved by FDA under a new drug application 

based on data showing safety and effectiveness and may be listed in the 

publication Approved Drug Products with Therapeutic Equivalence 
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 65

Evaluations. (http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm. This

document is maintained by the Food and Drug Administration, Center for 

Drug Evaluation and Research, Office of Pharmaceutical Science, Office of 

Generic Drugs. Also known as the “Orange Book,” this document provides 

“product-specific” listings rather than listings by compound and it is published 

annually with monthly supplements. However, as of the end of 1998, no hand 

antiseptics are listed in this publication since no new drug applications have 

been submitted and approved for these products. 

2. A hand antiseptic active ingredient may be identified by FDA in the 

monograph for OTC (over-the-counter) Health-Care Antiseptic Drug Products 

under the antiseptic handwash category. Since hand antiseptic products are 

intended and labeled for topical antimicrobial use by food employees in the 

prevention of disease in humans, these products are "drugs" under the 

Federal Food, Drug, and Cosmetic Act § 201(g). As drugs, hand antiseptics 

and dips must be manufactured by an establishment that is duly registered 

with the FDA as a drug manufacturer; their manufacturing, processing, 

packaging, and labeling must be performed in conformance with drug Good 

Manufacturing Practices (GMP's); and the product must be listed with FDA as 

a drug product. 

Products having the same formulation, labeling, and dosage form as those that existed 

in the marketplace on or before December 4, 1975, for hand antiseptic use by food 

handlers, are being evaluated under the Over-the-Counter (OTC) Drug Review by 

FDA’s Center for Drug Evaluation and Research. However, as of May 2005, a final OTC 

drug monograph for these products has not been finalized. Therefore, FDA has not 

made a final determination that any of these products are generally recognized as safe 

and effective (GRAS/E). 

GRAS/E antimicrobial ingredients for hand sanitizer use by food handlers will be 

identified in a future final monograph issued under the OTC Drug Review. Information 

about whether a specific product is covered by the proposed monograph may be 

obtained from the tentative final monograph (TFM) for “Health Care Antiseptic Drug 

Products for OTC Human Use; Proposed Rule.” This TFM, which was published in the 

Federal Register of June 17, 1994 (59 FR 31402), describes the inclusion of hand 

sanitizers in this Review on page 31440 under Comment 28 of Part II. Information about 

whether a specific product is included in this proposed monograph may also be 

available from the manufacturer. 

Questions regarding acceptability of a hand antiseptic with respect to OTC compliance 

may be directed to the Office of Unapproved Drugs and Labeling Compliance, Center 

for Drug Evaluation & Research Food and Drug Administration 10903 New Hampshire 

Ave., Building 51, 5th Floor, Silver Spring, MD 20993. Specific product 

label/promotional information and the formulation are required for determining a 

product’s regulatory status. 
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 66

As a Food Additive

To be subject to regulation under the food additive provisions of the Federal Food, 

Drug, and Cosmetic Act, the substances in a hand antiseptic must reasonably be 

expected to become a component of food based upon the product’s intended use. 

Where the substances in a hand antiseptic are reasonably expected to become a 

component of food based upon the product’s intended use, circumstances under which 

those substances may be legally used include the following: 

1. The intended use of a substance may be exempted from regulation as a food 

additive under 21 CFR 170.39 Threshold of regulation for substances used in 

food-contact articles. A review by FDA’s Center for Food Safety and Applied 

Nutrition is required in order to determine whether such an exemption can be 

granted. 

2. The intended use of a substance, including substances that contact food such as 

those in hand antiseptics, may be “generally recognized as safe (GRAS)” within 

the meaning of the FFDCA. A partial listing of substances with food uses that are 

generally recognized as safe may be found in CFR Parts 182, 184, and 186. 

These lists are not exhaustive because the FFDCA allows for independent GRAS 

determinations. 

For the use of a substance to be GRAS within the meaning of the FFDCA, there 

must be publicly available data that demonstrate that the substance is safe for its 

intended use. There also must be a basis to conclude that there is a consensus 

among qualified experts that these publicly available data establish safety. If the 

use of a substance in food is GRAS, it is not subject to premarket review by FDA. 

While there is no legal requirement to notify FDA of an independent GRAS 

determination, a number of firms have chosen to do so with the expectation of 

receiving a response letter from FDA (see FDA’s Inventory of GRAS Notices at 

(http://www.fda.gov/Food/FoodIngredientsPackaging/GenerallyRecognizedasSaf

eGRAS/GRASListings/default.htm). Although such a letter does not affirm the 

independent GRAS determination, it is an opportunity for the firm to receive 

comment from FDA regarding the materials supporting its determination. 

3. The intended use of a substance may be the subject of a prior sanction, which is 

an explicit approval by the FDA or the United States Department of Agriculture 

(USDA) prior to September 6, 1958. All known prior sanctions are published 

under 21 CFR Part 181. 

4. A substance may be the subject of a Food Contact Substance Notification that 

became effective in accordance with the FFDCA Section 409 (h). Substances 

that are the subject of an effective food-contact substance notification are listed, 

along with conditions of safe use, in the FDA Inventory of Effective Food Contact 

Substance (FCS) Notifications. This list is available on-line at: Inventory of 

Effective Food Contact Substance (FCS) Notifications 

(http://www.fda.gov/Food/FoodIngredientsPackaging/FoodContactSubstancesFC
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S/ucm116567.htm). A food-contact substance that is the subject of an effective 

notification submitted under FFDCA 409(h) does not include similar or identical 

substances manufactured or prepared by any person other than the 

manufacturer identified in that notification.

The Division of Food Contact Substance Notifications does not certify or provide 

approvals for specific products. However, if the intended use of a substance in contact 

with food meets the requirements of 21 CFR 170.39 Threshold of regulation for 

substances used in food-contact articles, FDA may provide a letter to a firm stating that 

the intended use of this product is exempt from regulation as a food additive. However, 

the product must be the subject of a new drug application or under FDA’s OTC Drug 

Review to be legally marketed. 

Questions regarding the regulatory status of substances in hand antiseptics as food 

additives may be directed to the Division of Food Contact Substance Notifications, HFS275, 5100 Paint Branch Parkway, College Park, MD 20740. It may be helpful or 

necessary to provide label/promotional information when inquiring about a specific 

substance. 

Fingernails

2-302.11 Maintenance.

The requirement for fingernails to be trimmed, filed, and maintained is designed to 

address both the cleanability of areas beneath the fingernails and the possibility that 

fingernails or pieces of the fingernails may end up in the food due to breakage. Failure 

to remove fecal material from beneath the fingernails after defecation can be a major 

source of pathogenic organisms. Ragged fingernails present cleanability concerns and 

may harbor pathogenic organisms.

Jewelry

2-303.11 Prohibition.

Items of jewelry such as rings, bracelets, and watches may collect soil and the 

construction of the jewelry may hinder routine cleaning. As a result, the jewelry may act 

as a reservoir of pathogenic organisms transmissible through food. 

The term “jewelry” generally refers to the ornaments worn for personal adornment and 

medical alert bracelets do not fit this definition. However, the wearing of such bracelets 

carries the same potential for transmitting disease-causing organisms to food. If a food 

worker wears a medical alert or medical information bracelet, the conflict between this 

need and the Food Code’s requirements can be resolved through reasonable 

accommodation in accordance with the Americans with Disabilities Act. The person in 

charge should discuss the Food Code requirement with the employee and together they 

can work out an acceptable alternative to a bracelet. For example, the medical alert 

information could be worn in the form of a necklace or anklet to provide the necessary 

medical information without posing a risk to food. Alternatives to medical alert bracelets 
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are available through a number of different companies (e.g., an internet search using 

the term “medical alert jewelry” leads to numerous suppliers). 

An additional hazard associated with jewelry is the possibility that pieces of the item or 

the whole item itself may fall into the food being prepared. Hard foreign objects in food 

may cause medical problems for consumers, such as chipped and/or broken teeth and 

internal cuts and lesions. 

Outer Clothing

2-304.11 Clean Condition.

Dirty clothing may harbor diseases that are transmissible through food. Food employees 

who inadvertently touch their dirty clothing may contaminate their hands. This could 

result in contamination of the food being prepared. Food may also be contaminated 

through direct contact with dirty clothing. In addition, employees wearing dirty clothes 

send a negative message to consumers about the level of sanitation in the 

establishment. 

Food contamination prevention

2-401.11 Eating, Drinking, or Using Tobacco Products.

Proper hygienic practices must be followed by food employees in performing assigned 

duties to ensure the safety of the food, prevent the introduction of foreign objects into 

the food, and minimize the possibility of transmitting disease through food. Smoking or 

eating by employees in food preparation areas is prohibited because of the potential 

that the hands, food, and food-contact surfaces may become contaminated. Insanitary 

personal practices such as scratching the head, placing the fingers in or about the 

mouth or nose, and indiscriminate and uncovered sneezing or coughing may result in 

food contamination. Poor hygienic practices by employees may also adversely affect 

consumer confidence in the establishment.

Food preparation areas such as hot grills may have elevated temperatures and the 

excessive heat in these areas may present a medical risk to the workers as a result of 

dehydration. Consequently, in these areas food employees are allowed to drink from 

closed containers that are carefully handled.

2-401.12 Discharges from the Eyes, Nose, and Mouth.

Discharges from the eyes, nose, or mouth through persistent sneezing or coughing by 

food employees can directly contaminate exposed food, equipment, utensils, linens, and 

single-service and single-use articles. When these poor hygienic practices cannot be 

controlled, the employee must be assigned to duties that minimize the potential for 

contaminating food and surrounding surfaces and objects.

2-401.13 Use of Bandages, Finger Cots, or Finger Stalls.
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Bandages, finger cots or finger stalls represent a potential physical hazard when worn 

by a food employee during food preparation. This hazard presents the risk of food 

products being directly contaminated by the introduction of a foreign object. The risk can 

be minimized through the use of a single-use glove to cover a bandage, finger cot or 

finger stall used on the wrist, hand or finger.

Hair restraints

2-402.11 Effectiveness.

Consumers are particularly sensitive to food contaminated by hair. Hair can be both a 

direct and indirect vehicle of contamination. Food employees may contaminate their 

hands when they touch their hair. A hair restraint keeps dislodged hair from ending up in 

the food and may deter employees from touching their hair.

Animals

2-403.11 Handling Prohibition.

Dogs and other animals, like humans, may harbor pathogens that are transmissible 

through food. Handling or caring for animals that may be legally present is prohibited 

because of the risk of contamination of food employee hands and clothing. 

2-501.11 Clean-up of Vomiting and Diarrheal Events.

When an employee, customer, or other individual vomits or has a diarrheal event in a 

food establishment, there is a real potential for the spread of harmful pathogens in the 

establishment. Putting the proper response into action in a timely manner can help 

reduce the likelihood that food may become contaminated and that others may become 

ill as a result of the accident.

According to the CDC, Norovirus is the leading cause of foodborne disease outbreaks in 

the United States. More specifically, Noroviruses are the most common cause of 

sporadic cases and outbreaks of acute gastroenteritis. Norovirus is the most common 

cause of gastroenteritis in people of all ages and it is responsible for greater than 50% 

of all foodborne gastroenteritis outbreaks. CDC estimates that 21 million cases of acute 

gastroenteritis are due to Norovirus infection. 

Noroviruses can be highly contagious, and it is thought that an inoculum of as few as 

10-18 viral particles may be sufficient to infect an individual. Transmission occurs via 

foodborne and person-to-person routes, airborne inhalation of vomitus droplets, and 

also through contact with contaminated environmental surfaces. Good evidence exists 

for transmission due to aerosolization of vomitus that presumably results in droplets 

contaminating surfaces or entering the oral mucosa and being swallowed. 

In addition, the potential transmission level of Norovirus shed in the feces at levels up to 

1 trillion viral particles per gram of feces and one projectile vomiting incident can 

contaminate the environment with 300,000 viral particles. One study found that 
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employees who reported having cleaned up vomitus were more likely to contract illness 

that those who did not. 

Norovirus causes acute onset of vomiting (often explosive) and diarrhea (also often 

explosive) which can contaminate surfaces and become airborne increasing the 

chances of additional infections. A recent study has also shown that the bathroom 

environment was identified as a major reservoir of human Norovirus, even in the 

absence of an ill individual on site. Studies have shown that Norovirus can survive on 

fomite surfaces for up to at least 5 days at room temperature and that routine cleaning, 

without a disinfectant specifically to address Norovirus, may be ineffective in eliminating 

its presence on fomite surfaces and can even serve as a means of spreading the virus 

to other fomites. 

Effective clean up of vomitus and fecal matter in a food establishment should be 

handled differently from routine cleaning procedures. It should involve a more stringent 

cleaning and disinfecting process. Some compounds that are routinely used for 

sanitizing food-contact surfaces and disinfecting countertops and floors, such as certain 

quaternary ammonium compounds, may not be effective against Norovirus. It is 

therefore important that food establishments have procedures for the cleaning and 

disinfection of vomitus and/or diarrheal contamination events that address, among other 

items, the use of proper disinfectants at the proper concentration.

Consumers are at risk of contracting Norovirus illness from direct exposure to vomitus 

or from exposure to airborne Norovirus from vomitus. Additionally, exposed food 

employees are also at risk of contracting Norovirus illness and can subsequently 

transfer the virus to ready-to-eat food items served to consumers.

The Food Code specifies that the Person in Charge is to exclude or restrict a food 

employee who exhibits, or reports a symptom, or who reports a diagnosed illness or a 

history of exposure to Norovirus. A clean-up and response plan is intended to address 

situations where a food employee or other individual becomes physically ill in areas 

where food may be prepared, stored or served. Once such an episode has occurred, 

timely effective clean-up is imperative. Key to achieving an appropriate, timely response 

by food employees is the availability and access to a written plan upon which to refer to 

for reference.

When developing a written plan that addresses the need for the cleaning and 

disinfection of a vomitus and/or diarrheal contamination event, a food establishment 

should consider:

• The procedures for containment and removal of any discharges, including 

airborne particulates;

• The procedure for cleaning, sanitizing, and, as necessary, the disinfection of any 

surfaces that may have become contaminated;

• The procedures for the evaluation and disposal of any food that may have been 

exposed to discharges;

• The availability of effective disinfectants, such as EPA registered disinfection 

products sufficient to inactivate norovirus, personal protective equipment, and 
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other cleaning and disinfecting equipment and appurtenances intended for 

response and their proper use;

• Procedures for the disposal and/or cleaning and disinfection of tools and 

equipment used to clean up vomitus or fecal matter;

• The circumstances under which a food employee is to wear personal protective 

equipment for cleaning and disinfecting of a contaminated area;

• Notification to food employees on the proper use of personal protective 

equipment and procedures to follow in containing, cleaning, and disinfecting a 

contaminated area; 

• The segregation of areas that may have been contaminated so as to minimize 

the unnecessary exposure of employees, customers and others in the facility to 

the discharges or to surfaces or food that may have become contaminated;

• Minimizing risk of disease transmission through the exclusion and restriction of ill 

employees as specified in §2-201.12 of the Food Code;

• Minimizing risk of disease transmission through the prompt removal of ill 

customers and others from areas of food preparation, service and storage; and 

• The conditions under which the plan will be implemented.

When a food employee has been diagnosed, has recent history or exposure to, or is the 

suspect source of a confirmed disease outbreak of Norovirus, it must be reported to the 

person in charge per the FDA Food Code in subparagraphs 2-201.11 (A)(2)(a), 2-

201.11(A)(4)(a), 2-201.11(A)(5)(a), and ¶2-201.11(B). If a food employee has been 

diagnosed with Norovirus it must also be reported to the regulatory authority. Refer to 

public health reasons for §2-201.11 Responsibility of the Person in Charge, Food 

Employees, and Conditional Employees for more information about appropriate 

employee health policies. 
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Chapter 3. Food

Condition

3-101.11 Safe, Unadulterated, and Honestly Presented.

Sources

3-201.11 Compliance with Food Law.

Refer to the public health reason for § 3-401.11. 

Source

A primary line of defense in ensuring that food meets the requirements of § 3-101.11 is 

to obtain food from approved sources, the implications of which are discussed below.

However, it is also critical to monitor food products to ensure that, after harvesting and 

processing, they do not fall victim to conditions that endanger their safety, make them 

adulterated, or compromise their honest presentation. The regulatory community, 

industry, and consumers should exercise vigilance in controlling the conditions to which 

foods are subjected and be alert to signs of abuse. FDA considers food in hermetically 

sealed containers that are swelled or leaking to be adulterated and actionable under the 

Federal Food, Drug, and Cosmetic Act. Depending on the circumstances, rusted and 

pitted or dented cans may also present a serious potential hazard. 

Food, at all stages of production, is susceptible to contamination. The source of food is 

important because pathogenic microorganisms may be present in the breeding stock of 

farm animals, in feeds, in the farm environment, in waters used for raising and freezing 

aquatic foods, and in soils and fertilizers in which plant crops are grown. Chemical 

contaminants that may be present in field soils, fertilizers, irrigation water, and fishing 

waters can be incorporated into food plants and animals. 

Sources of molluscan shellfish are a particular concern because shellfish are frequently 

consumed raw or in an undercooked state and thus receive neither heat treatment nor 

any other process that would destroy or inactivate microbial pathogens. For safety, 

these foods must be accompanied by certification that documents that they have been 

harvested from waters that meet the water quality standards contained in the National 

Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish. Certification 

also provides confidence that processing, packaging, and shipping have been 

conducted under sanitary conditions. 

Food should be purchased from commercial supplies under regulatory control. Home 

kitchens, with their varieties of food and open entry to humans and pet animals, are 

frequently implicated in the microbial contamination of food. Because commercial items 

seldom are eaten right away, the home kitchen's limited capacity for maintaining food at 

proper temperatures may result in considerable microbial growth and toxin production 

by microorganisms introduced through the diverse sources of contamination. Controlled 

processing is required for the safe preparation of food entering commerce. 
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Labeling - General

Sources of packaged food must be labeled in accordance with law. Proper labeling of 

foods allows consumers to make informed decisions about what they eat. Many 

consumers, as a result of an existing medical condition, may be sensitive to specific 

foods or food ingredients. This sensitivity may result in dangerous medical 

consequences should certain foods or ingredients be unknowingly consumed. In 

addition, consumers have a basic right to be protected from misbranding and fraud. 

Except for certain species of large tuna and raw molluscan shellfish, if fish are intended 

for raw consumption, they must be properly frozen before they are served. If this 

process is done off-premises, purchase specifications ensuring that proper freezing 

techniques are used to destroy parasites must be provided. Labeling should accompany 

the product to advise as to whether the product was frozen properly. This is necessary 

because fish from natural bodies of water may carry parasitic worms that can infect and 

injure consumers who eat such raw fish dishes as sushi, ceviche, green (lightly 

marinated) herring, and cold-smoked salmon. The worms are often deeply imbedded 

inside fish muscle. Thorough freezing kills these worms if the fish are subjected to a low 

enough temperature for a long enough time. 

Labeling for Fish

Except for raw molluscan shellfish, certain species of large tuna, certain aquacultured 

fish, and fish eggs that have been removed from the skein and rinsed, if fish are 

intended for raw or undercooked consumption, they must be properly frozen before they 

are served. If this process is done off-premises, purchase specifications ensuring that 

proper freezing techniques are used to destroy parasites must be provided. Labeling or 

other information should accompany the product to advise as to whether the product 

was frozen properly. This is necessary because fish from natural bodies of water may 

carry parasitic worms that can infect and injure consumers who eat such raw fish dishes 

as sushi, ceviche, green (lightly marinated) herring, and cold-smoked salmon. The 

worms are often deeply imbedded inside fish muscle. Thorough freezing kills these 

worms if the fish are subjected to a low enough temperature for a long enough time. 

Labeling for Juice

On July 8, 1998, FDA announced in the Federal Register a final rule that revised its 

food labeling regulations to require a warning statement on fruit and vegetable juice 

products that have not been processed to prevent, reduce, or eliminate pathogenic 

microorganisms that may be present. FDA took this action to inform consumers, 

particularly those at greatest risk, of the hazard posed by such juice products. FDA 

expects that providing this information to consumers will allow them to make informed 

decisions on whether to purchase and consume such juice products, thereby reducing 

the incidence of foodborne illnesses and deaths caused by the consumption of these 

juices. 

On July 18, 2001 FDA announced a final rule designed to improve the safety of fruit and 

vegetable juice and juice products. Under the rule, juice processors must use Hazard 
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Analysis and Critical Control Point (HACCP) principles for juice processing. Processors 

making shelf-stable juices or concentrates that use a single thermal processing step are 

exempt from the microbial hazard requirements of the HACCP regulation. Retail 

establishments where packaged juice is made and only sold directly to consumers 

(such as juice bars) are not required to comply with this regulation. 

Rather, the Food Code requires fresh fruit or vegetable juices that are packaged at retail 

(untreated juices or beverages containing untreated juices that are offered to 

consumers as prepackaged foods) to be processed under HACCP with a 5 log 

reduction in pathogens of concern OR bear the warning statement as specified in 

21 CFR Section 101.17(g). That statement is: “WARNING: This product has not been 

pasteurized and, therefore, may contain harmful bacteria that can cause serious illness 

in children, the elderly, and persons with weakened immune systems.” Refer to Chapter 

1 for the definition of juice. It is important to note that the definition of "juice" includes 

puréed fruits and vegetables, which are commonly prepared for service to highly 

susceptible populations. 

Food establishments that serve a highly susceptible population (HSP) cannot serve 

prepackaged juice that bears the warning label and they must serve only pasteurized 

juice. For juice only, this population includes children who are age 9 or less and receive 

food in a school, day care setting, or similar facility that provides custodial care. 

Unpackaged juice (glasses of juice prepared at a juice bar, for example) does not 

require the 5 log reduction nor a warning statement or other consumer advisory (juice is 

not an animal food and therefore not covered by section 3-603.11) when prepared and 

served at retail. Usually the juice is served by the glass or in small batches compared to 

a commercial juice processor. The risk of using “drops” and damaged fruits or 

vegetables is much less at retail because of buyer specs that provide higher quality 

produce, meaning that fruits for juicing are less likely to be of a lower quality or 

damaged. 

Additional information is available in the document, “Guidance for Industry: Exemptions 

from the Warning Label Requirement for Juice - Recommendations for Effectively 

Achieving a 5-Log Pathogen Reduction; Final Guidance”, October 7, 2002 which can be 

found at: 

http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformatio

n/LabelingNutrition/ucm058962.htm or obtained from the FDA Office of Nutritional 

Products Labeling and Dietary Supplements. 
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Labeling for Meat and Poultry

Retail food establishments that process and package meat or poultry in a form that is 

not ready-to-eat (NRTE), are obligated by Federal regulation to label the product with 

safe handling instructions (SHI). USDA issued final rules on August 8, 1994 requiring all 

raw meat or poultry products have a safe-handling label or sticker or be accompanied 

by a leaflet that contains information on proper handling and cooking procedures. The 

intent of this requirement is to ensure that all consumers are alerted to the fact that such 

products may contain bacteria and that food safety hinges upon thoroughly cooking the 

product, regardless of where they obtain the products. That is, the labeling would exist if 

they obtain their meat and poultry at an establishment that handles only prepackaged 

and prelabeled products, or if they obtain their meat or poultry at an operation such as a 

supermarket with a meat processing operation or from a small neighborhood butcher. 

Labeling Guidance for Irradiated Raw Meat and Meat Products 

On December 23,1999, the U.S. Department of Agriculture, Food Safety and Inspection 

Service (USDA/FSIS) issued a final regulation to permit the use of ionizing radiation to 

reduce foodborne pathogens, including Escherichia coli O157:H7, and extend the shelf 

life of raw refrigerated and frozen meat and meat products 

(https://www.federalregister.gov/documents/1999/12/23/99-32660/irradiation-of-meatfood-products).

The final regulations are published in Title 9 of the Code of Federal Regulations (9 CFR 

424.21 Use of food ingredients and sources of radiation and provide that raw 

refrigerated products may receive a maximum absorbed dose of no more than 4.5 kGy, 

and that frozen product receive no more than 7.0 kGy, in accordance with the FDA 

restrictions provided for in Title 21 of the Code of Federal Regulations (21 CFR 

179.26(a) Ionizing radiation for the treatment of food, (a) Energy sources). The 

regulations further require that all irradiated meat and meat products bear labeling that 

reflects that the product was irradiated, or that the product contains an irradiated meat 

or poultry product. This labeling requirement is applicable even at retail facilities where 

irradiated coarse ground beef might be finely ground for retail sale, or in cases where 

irradiated product is combined with other non-irradiated meat or poultry product for retail 

sale. 

In cases where the entire package of product is irradiated, the labeling must include 

both a statement and the international symbol, called the radura. Additionally, the 

product name must include the word “irradiated,” or the labeling must bear a disclosure 

statement such as, “treated with radiation” or “treated by irradiation.” If either statement 

is used, the logo must be placed in conjunction with the statement. If an irradiated meat 

or meat product is used to formulate a multi-ingredient product with other non-irradiated 

components, the irradiated meat ingredient must be identified as such in the ingredients 

statement, but the logo is not required. For example, the ingredients statement for a 

Chicken and Beef Sausage product that contains irradiated beef would be, Ingredients:

chicken, irradiated beef, seasonings (salt, pepper, spice), and the logo would not be 

required to be present. 
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All labels for products produced at federally inspected establishments bearing 

statements about irradiation must be submitted to USDA/FSIS for evaluation and 

approval prior to use. 

Optional labeling statements about the purpose of the irradiation process may be 

included on the labeling of irradiated products provided they are not false or misleading 

and have been evaluated first by USDA/FSIS. If such statements indicate a specific 

benefit from irradiation, such as a reduction of microbial pathogens, such statements 

must be substantiated by processing documentation and validated through the 

processing and Hazard Analysis and Critical Control Point (HACCP) system. Such 

validation and documentation of the HACCP system would only be applicable in 

federally inspected establishments. 

Because irradiation can substantially reduce and, in some situations, eliminate any 

detectable level of pathogenic bacteria, it is important that the meat products be held at 

the proper refrigerated temperatures to prevent growth of any pathogens present, and 

that the packaging is not compromised. Although comingling irradiated beef with nonirradiated meat or poultry is not prohibited under the current regulations, USDA/FSIS 

believes that such a process would decrease the benefit of irradiation by potentially 

exposing the irradiated product to pathogenic bacteria. While FSIS considers such 

comingling to be highly unlikely, if it did occur, a statement advising the consumer that 

the product contains both irradiated and non-irradiated components would be required. 

The Radura, International Symbol: 

Further information about labeling irradiated raw meat is available through Directive 

5000.15, Verification Activities for High Pressure Processing, Irradiation, and Microwave 

Tempering on the USDA/FSIS website at: 

https://www.fsis.usda.gov/sites/default/files/media_file/2021-08/5000.15.pdf. 

Irradiation Questions & Answers can be found at: 

https://www.fsis.usda.gov/sites/default/files/media_file/2020-08/IradQA.pdf. 

Irradiation and Food Safety FAQs can be found at: https://www.fsis.usda.gov/foodsafety/safe-food-handling-and-preparation/food-safety-basics/irradiation-and-foodsafety-faq
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Labeling for Raw Shell Eggs

The Code of Federal Regulations 21 CFR 101.17 Food Labeling warning, notice, and 

safe handling statements, paragraph (h) Shell eggs state in subparagraph (1), “The 

label of all shell eggs, whether in intrastate or interstate commerce, shall bear the 

following statement: ‘SAFE HANDLING INSTRUCTIONS: To prevent illness from 

bacteria; keep eggs refrigerated, cook eggs until yolks are firm, and cook foods 

containing eggs thoroughly.’” Further, in subparagraph (4) it states, “Shell eggs that 

have been, before distribution to consumers, specifically processed to destroy all viable 

Salmonella shall be exempt from the requirements of paragraph (h) of this section.” 

Labeling for Whole-muscle, Intact Beef Steaks

In the past, some steaks were labeled “intact” in order for a food establishment operator 

to determine a steak is a whole muscle, intact cut of beef that could therefore be 

undercooked and served without a consumer advisory. Processors could accommodate 

this need at the retail level by developing proposed labels, obtaining the necessary 

USDA Food Safety Inspection Service review and approval, and appropriately affixing 

the labels to their products. However, such intact labeling in practice was very rare. 

Rather, FSIS regulations and policies identify steaks that are non-intact (i.e., steaks that 

have not undergone mechanical tenderization including injection, vacuum tumbling with 

solutions, reconstruction, cubing, or pounding). Therefore, Section 3-201.11 has been 

revised to better reflect that a food establishment operator should obtain steaks that are 

either not labeled as non-intact (e.g., mechanically tenderized, blade tenderized, needle 

tenderized, contains X% added solutions, or formed) or do not appear non-intact due to 

cubing or pounding. FDA has also developed an intact steak decision-tree to help food 

establishment operators determine whether a steak is intact or non-intact and can be 

found at the following link: www.fda.gov/media/163808/download

Refer also to public health reason for § 3-602.11. 

3-201.12 Food in a Hermetically Sealed Container.

Processing food at the proper high temperature for the appropriate time is essential to 

kill bacterial spores that, under certain conditions in an airtight container, begin to grow 

and produce toxin. Of special concern is the lethal toxin of Clostridium botulinum, an 

organism whose spores (i.e., survival stages for non-growth conditions) are found 

throughout the environment. Even slight underprocessing of low acid food which is 

canned can be dangerous, because spoilage microbes are killed and there are no signs 

to warn consumers that botulinum spores have germinated into vegetative cells and 

produced their toxin. If these foods are not processed to be commercially sterile, they 

must be received frozen or under proper refrigeration. 

Refer also to the public health reason for §§ 3-101.11 and 3-201.11. 

3-201.13 Fluid Milk and Milk Products.

Milk, which is a staple for infants and very young children with incomplete immunity to 

infectious diseases, is susceptible to contamination with a variety of microbial 
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pathogens such as Shiga toxin-producing Escherichia coli, Salmonella spp., and

Listeria monocytogenes, and provides a rich medium for their growth. This is also true 

of milk products. Pasteurization is required to eliminate pathogen contamination in milk 

and products derived from milk. Dairy products are normally perishable and must be 

received under proper refrigeration conditions. 

3-201.14 Fish.

After December 18, 1997, all processors of fish are required by 21 CFR 123 to have 

conducted a hazard analysis of their operation, identify each hazard that is reasonably 

likely to occur, and implement a HACCP plan to control each identified hazard. Retailers 

should assure that their seafood suppliers have complied with this requirement. 

Hazards known to be associated with specific fish species are discussed in the FDA 

Fish and Fishery Products Hazards and Controls Guide, available from the FDA Office 

of Seafood. Species-related hazards include pathogens, parasites, natural toxins, 

histamine, chemicals, and drugs. 

The seafood implicated in histamine poisoning are the scombroid toxin-forming species, 

defined in 21 CFR 123.3(m) as meaning bluefish, mahi-mahi, tuna, and other species, 

whether or not in the family Scombridae, in which significant levels of histamine may be 

produced in the fish flesh by decarboxylation of free histidine as a result of exposure of 

the fish after capture to temperatures that allow the growth of mesophilic bacteria. 

Ciguatera toxin is carried to humans by contaminated fin fish from the extreme 

southeastern U.S., Hawaii, and subtropical and tropical areas worldwide. In the south 

Florida, Bahamian, and Caribbean regions, barracuda, amberjack, horse-eye jack, black 

jack, other large species of jack, king mackerel, large groupers, and snappers are 

particularly likely to contain ciguatoxin. Many other species of large predatory fishes 

may be suspect. In Hawaii and throughout the central Pacific, barracuda, amberjack, 

and snapper are frequently ciguatoxic, and many other species both large and small are 

suspect. Mackerel and barracuda are frequently ciguatoxic from mid to northeastern 

Australian waters. 

Recreationally caught fish

Recreationally caught fish received for sale or service may be approved by the 

regulatory authority. The EPA recognizes that fish are a healthy part of our diet and 

recognizes fishing as an all-American recreational pastime, however, they add the 

cautionary note that some individuals, such as pregnant women and small children, may 

need to limit their intake of certain noncommercial fish. Recreationally caught fish may 

contain possible contaminants that may pose health risks. Fish advisories can be found 

in the EPA Listing of Fish Advisories website at: http://www.epa.gov/waterscience/fish/. 

States issue fish consumption advisories if elevated concentrations of chemicals such 

as mercury or dioxin are found in local fish. For most people, the risk from mercury by 

eating fish is not a health concern. Yet, some fish and shellfish contain higher levels of 

mercury that may harm an unborn baby or young child's developing nervous system. 

Therefore, the FDA and the EPA recently advised women who may become pregnant, 
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

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pregnant women, nursing mothers, and young children to avoid some types of fish and 

eat fish and shellfish that are lower in mercury. 

(http://www.epa.gov/waterscience/fishadvice/advice.html). 

State-issued advisories apply primarily to non-commercial fish obtained through sport, 

recreation, and subsistence activities. Each advisory is different; it may recommend 

unrestricted, limited, or totally restricted consumption; may be targeted to everyone or 

limited to women, children, or other people at risk; and may apply to certain species or 

sizes of fish or a specific waterbody. 

States may issue safe-eating guidelines in addition to issuing fish advisories. A fish 

advisory is issued to warn the public of the potential human health risks from chemical 

contamination of certain species from particular types of waterbodies such as lakes, 

rivers, and/ or coastal waters within the State. In contrast, a safe-eating guideline is 

issued to inform the public that fish from specific waterbodies have been tested for 

chemical contaminants and the fish from these waters are safe to eat without 

consumption restrictions.

Regulatory authorities are encouraged to monitor and review the National Listing of Fish 

Advisories (See August 2004 EPA Fact Sheet at 

http://www.epa.gov/waterscience/fish/advisories/factsheet.pdf as well as the local 

listings, as part of the decision-making process regarding the approval of recreationally 

caught fish being used in food establishments.

3-201.15 Molluscan Shellfish.

Pathogens found in waters from which molluscan shellfish are harvested can cause 

disease in consumers. Molluscan shellfish include: 1) oysters; 2) clams; 3) mussels; 

and, 4) scallops, except where the final product is the shucked adductor muscle only. 

The pathogens of concern include both bacteria and viruses. 

Pathogens from the harvest area are of particular concern in molluscan shellfish 

because: 1) environments in which molluscan shellfish grow are commonly subject to 

contamination from sewage, which may contain pathogens, and to naturally occurring 

bacteria, which may also be pathogens; 2) molluscan shellfish filter and concentrate 

pathogens that may be present in surrounding waters; and, 3) molluscan shellfish are 

often consumed whole, either raw or partially cooked. 

To minimize the risk of molluscan shellfish containing pathogens of sewage origin, State 

and foreign government agencies, called Shellfish Control Authorities, classify waters in 

which molluscan shellfish are found, based, in part, on an assessment of water quality. 

As a result of these classifications, molluscan shellfish harvesting is allowed from some 

waters, not from others, and only at certain times or under certain restrictions from 

others. Shellfish Control Authorities then exercise control over the molluscan shellfish 

harvesters to ensure that harvesting takes place only when and where it has been 

allowed. 
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Significant elements of Shellfish Control Authorities' efforts to control the harvesting of 

molluscan shellfish include: 1) a requirement that containers of in-shell molluscan 

shellfish (shellstock) bear a tag that identifies the type and quantity of shellfish, 

harvester, harvest location, and date of harvest; and, 2) a requirement that molluscan 

shellfish harvesters be licensed; 3) a requirement that processors that shuck molluscan 

shellfish or ship, reship, or repack the shucked product be certified; and, 4) a 

requirement that containers of shucked molluscan shellfish bear a label with the name, 

address, and certification number of the shucker-packer or repacker. 

Pathogens, such as Vibrio vulnificus, Vibrio parahaemolyticus, Vibrio cholerae, 

and Listeria monocytogenes that may be present in low numbers at the time that 

molluscan shellfish are harvested, may increase to more hazardous levels if they are 

exposed to time/temperature abuse. To minimize the risk of pathogen growth, Shellfish 

Control Authorities place limits on the time between harvest and refrigeration. The 

length of time is dependant upon either the month of the year or the average monthly 

maximum air temperature (AMMAT) at the time of harvest, which is determined by the 

Shellfish Control Authority. 

Paralytic shellfish poisoning (PSP) results from shellfish feeding upon toxic 

microorganisms such as dinoflagellates. In the U.S., PSP is generally associated with 

the consumption of molluscan shellfish from the northeast and northwest coastal 

regions of the U.S. PSP in other parts of the world has been associated with molluscan 

shellfish from environments ranging from tropical to temperate waters. In addition, in the 

U.S., PSP toxin has recently been reported from the viscera of mackerel, lobster, 

dungeness crabs, tanner crabs, and red rock crabs. 

Neurotoxic shellfish poisoning (NSP) in the U.S. is generally associated with the 

consumption of molluscan shellfish harvested along the coast of the Gulf of Mexico, 

and, sporadically, along the southern Atlantic coast. There has been a significant 

occurrence of toxins similar to NSP in New Zealand, and some suggestions of 

occurrence elsewhere. 

For diarrhetic shellfish poisoning there has been no documented occurrence to date in 

the U.S. However, instances have been documented in Japan, southeast Asia, 

Scandinavia, western Europe, Chile, New Zealand, and eastern Canada. 

Amnesic shellfish poisoning (ASP) is generally associated with the consumption of 

molluscan shellfish from the northeast and northwest coasts of North America. It has not 

yet been a problem in the Gulf of Mexico, although the algae that produce the toxin 

have been found there. ASP toxin has recently been identified as a problem in the 

viscera of dungeness crab, tanner crab, red rock crab, and anchovies along the west 

coast of the United States. 

Marine toxins are not ordinarily a problem in scallops if only the adductor muscle is 

consumed. However, products such as roe-on scallops and whole scallops do present a 

potential hazard for natural toxins. 
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To reduce the risk of illness associated with raw shellfish consumption, the Food and 

Drug Administration (FDA) administers the National Shellfish Sanitation Program 

(NSSP). The NSSP is a tripartite, cooperative action plan involving Federal and State 

public health officials and the shellfish industry. Those groups work together to improve 

shellfish safety. States regularly monitor waters to ensure that they are safe before 

harvesting is permitted. FDA routinely audits the States' classification of shellfish 

harvesting areas to verify that none pose a threat to public health. Patrolling of closed 

shellfishing waters minimizes the threat of illegal harvesting or "bootlegging" from 

closed waters. Bootlegging is a criminal activity and a major factor in shellfish-borne 

illnesses. Purchases from certified dealers that adhere to NSSP controls is essential to 

keep risks to a minimum. 

3-201.16 Wild Mushrooms.

Over 5000 species of fleshy mushrooms grow naturally in North America. The vast 

majority have never been tested for toxicity. It is known that about 15 species are 

deadly and another 60 are toxic to humans whether they are consumed raw or cooked. 

An additional 36 species are suspected of being poisonous, whether raw or cooked. At 

least 40 other species are poisonous if eaten raw, but are safe after proper cooking.

Some wild mushrooms that are extremely poisonous may be difficult to distinguish from 

edible species. In most parts of the country there is at least one organization that 

includes individuals who can provide assistance with both identification and program 

design. Governmental agencies, universities, and mycological societies are examples of 

such groups. 

Regulatory authorities have expressed their difficulty in regulating wild harvested 

mushrooms at retail. There are many different approaches in regulating the sale and 

service of wild harvested mushrooms. The differences in approach could be due to 

geography, the type of wild mushrooms that typically grow in a particular region and/or 

local/state laws that are enforced. The Conference for Food Protection (CFP) has 

attempted to develop a national model or standards for regulatory programs to address 

and recognize wild harvested mushroom identification. The difficulty in trying to get 

consensus on national model/standards lies in the question of what is the best national 

model/standard available that state/local regulatory authorities can apply in a 

meaningful way to ensure wild harvested mushrooms sold at retail are obtained from a 

safe source. 

With the change in the codified text, the regulatory authority will have the flexibility to 

apply their laws and/or policies for wild harvested mushroom identification. At a 

minimum, when developing a wild harvest mushroom identification program, the 

following elements should be addressed:

• Developing resources & criteria to select wild mushroom species for service or 

sale,

• Establishing record-keeping and traceability to assure safety of wild harvested 

mushrooms,

• Written buyer specifications that include:
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Annex 3 - 82

a. Identification by the scientific name and the common name of the 

mushroom species,

b. A statement that the mushroom was identified while in the fresh states,

c. The name and contact information of the person who identified the 

mushroom and the mushroom seller, and

d. A statement as to the qualifications and training of the identifier, 

specifically related to mushroom identification.

• Development of qualifications and training curriculum that could be used for 

further training of mushroom identifiers

In addition, the CFP has guidance material titled “Draft Model Guidance for Wild 

Harvested Mushrooms” posted on their website at http://www.foodprotect.org so state 

and local regulatory authorities can use the information to develop and implement their 

own wild harvested mushroom program. The guidance document is still a work in 

progress.

Refer also to the public health reason for §§ 3-101.11 and 3-201.11. 

3-201.17 Game Animals.

The primary concern regarding game animals relates to animals obtained in the wild. 

Wild game animals may be available as a source of food only if a regulatory inspection 

program is in place to ensure that wild animal products are safe. This is important 

because wild animals may be carriers of viruses, rickettsiae, bacteria, or parasites that 

cause illness (zoonoses) in humans. Some of these diseases can be severe in the 

human host. In addition to the risk posed to consumers of game that is not subject to an 

inspection program, there is risk to those who harvest and prepare wild game because 

they may contract infectious diseases such as rabies or tularemia. 

Specifications for receiving

3-202.11 Temperature.

Temperature is one of the prime factors that controls the growth of bacteria in food. 

Many, though not all, types of pathogens and spoilage bacteria are prevented from 

multiplying to microbiologically significant levels in properly refrigerated foods that are 

not out of date. USDA published a final rule (63 FR 45663, August 27, 1998 Shell Eggs; 

Refrigeration and Labeling Requirements) to require that shell eggs packed for 

consumer use be stored and transported at an ambient temperature not to exceed 

7.2oC (45oF). 

High temperatures for a long enough time, such as those associated with thorough 

cooking, kill or inactivate many types of microorganisms. However, cooking does not 

always destroy the toxins produced in foods by certain bacteria (such as the 

enterotoxins of Staphylococcus aureus). Cooking or hot holding that follows 

temperature abuse may not make the food safe. Keeping cooked foods hot as required 

in the Code prevents significant regrowth of heat-injured microorganisms and prevents 

recontamination with bacteria that are newly introduced.
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3-202.12 Additives.

It is imperative for safety that food supplies come from sources that are in compliance 

with laws regarding chemical additives and contaminants.

Food additives are substances which, by their intended use, become components of 

food, either directly or indirectly. They must be strictly regulated. In excessive amounts 

or as a result of unapproved application, additives may be harmful to the consumer. 

Unintentional contaminants or residues also find their way into the food supply. The 

tolerances or safe limits designated for these chemicals are determined by risk 

assessment evaluations based on toxicity studies and consumption estimates. 

Food and Color additives must be used in compliance with a federal food, or color 

additive regulation, an effective food-contact notification, or a threshold of regulation 

exemption. Such regulations, notifications, and exemptions are generally composed of 

three parts: the identity of the substance, specifications including purity or physical 

properties, and limitations on the conditions of use. In order for a food, or color additive 

use to be in compliance, the use must comply with all three criteria. 

Federal Food Additive regulations are found in Title 21 CFR, Parts 172-180. Color 

additive regulations are found in Title 21 CFR Parts 73-Subpart A, 74-Subpart A, 81 and 

82. Effective food-contact notifications are listed at 

http://www.accessdata.fda.gov/scripts/fcn/fcnNavigation.cfm?rpt=fcsListing&displayAll=f

alse&page=17, and threshold of regulation exemptions are listed at 

http://www.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/ThresholdRegul

ationExemptions/ucm093685.htm. 

Other substances that are added to food include those prior sanctioned for use in food 

by either the FDA or USDA, or those generally recognized as safe for their intended use 

in food. Some of these are listed in Title 21 CFR Parts 181-186, Title 9 CFR Section 

424.21(b) and at

http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/default.h

tm. Tolerances and exemptions from tolerance for pesticide chemical residues in or on 

food are found in Title 40 CFR Part 180. Substances that are prohibited from use in 

human food are listed in Title 21 CFR Part 189.

3-202.13 Eggs.

Damaged shells permit the entry of surface bacteria to the inside of eggs. Eggs are an 

especially good growth medium for many types of bacteria. Damaged eggs must not be 

used as food. 

The Definition of "Restricted Egg" contains several terms that are explained in this 

paragraph. An egg may be restricted because it is a/an:

1. "Check" meaning an egg that has a broken shell or crack in the shell but 

has its shell membranes intact and contents not leaking. 
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2. "Dirty egg or Dirties" meaning an egg that has a shell that is unbroken and 

has adhering dirt, foreign material, or prominent stains.

3. "Incubator reject" meaning an egg that has been subjected to incubation 

and has been removed from incubation during the hatching operations as 

infertile or otherwise unhatchable. 

4. "Inedible" meaning eggs of the following descriptions: Black rots, yellow 

rots, white rots, mixed rots, sour eggs, eggs with green whites, eggs with 

stuck yolks, moldy eggs, musty eggs, eggs showing blood rings, and eggs 

containing embryo chicks (at or beyond the blood ring stage). 

5. "Leaker" meaning an egg that has a crack or break in the shell and shell 

membranes to the extent that the egg contents are exposed or are 

exuding or free to exude through the shell.

6. "Loss" meaning an egg that is unfit for human food because it is smashed 

or broken so that its contents are leaking; or overheated, frozen, or 

contaminated; or an incubator reject; or because it contains a bloody 

white, large meat spots, a large quantity of blood, or other foreign material. 

On December 5, 2000 Federal regulations were amended to require that shell egg 

cartons bear safe handling instructions and be placed under refrigeration at 45°F or 

lower upon delivery at retail establishments (65 FR 76091, December 5, 2000, Food 

Labeling, Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of Shell Eggs 

Held for Retail Distribution). The amended provisions include: 

• 21 CFR Part 16 Regulatory Hearing before the Food and Drug Administration, 

§ 16.5 Inappplicability and limited applicability, (4) A hearing on an order for relabeling, diversion or destruction of shell eggs...

• 21 CFR Part 101 Food Labeling § 101.17 Food labeling warning, notice, and safe 

handling statements, (h) Shell eggs. 

• 21 CFR Part 115 Shell Eggs, § 115.50 Refrigeration of shell eggs held for retail 

distribution. 

The labeling rule became effective September 4, 2001, and the refrigeration rule 

became effective June 4, 2001. These rules are one part of a larger farm-to-table 

approach for ensuring the safety of our nation’s egg supply. The public health goal is a 

50 percent reduction in all salmonellosis and a 50 percent reduction in Salmonellae 

Enteritidis illnesses by 2010. 

3-202.14 Eggs and Milk Products, Pasteurized.

Liquid egg, fluid milk, and milk products are especially good growth media for many 

types of bacteria and must be pasteurized. Pasteurization is a heat process that will kill 

or inactivate bacteria and other harmful microorganisms likely to be in these 

time/temperature control for safety foods. Freezing and drying of unpasteurized 

products will stop microbial growth and may reduce their bacterial populations; however, 

some organisms will survive because neither process invariably kills bacteria. Under 
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Annex 3 - 85

certain conditions, freezing and drying may preserve microbes. An alternative to 

pasteurization may be applicable to certain cheese varieties cured or aged for a 

specified amount of time prior to marketing for consumption. 

3-202.15 Package Integrity.

Damaged or incorrectly applied packaging may allow the entry of bacteria or other 

contaminants into the contained food. If the integrity of the packaging has been 

compromised, contaminants such as Clostridium botulinum may find their way into 

the food. In anaerobic conditions (lack of oxygen), botulism toxin may be formed. 

Packaging defects may not be readily apparent. This is particularly the case with low 

acid canned foods. Close inspection of cans for imperfections or damage may reveal 

punctures or seam defects. In many cases, suspect packaging may have to be 

inspected by trained persons using magnifying equipment. Irreversible and even 

reversible swelling of cans (hard swells and flippers) may indicate can damage or 

imperfections (lack of an airtight, i.e., hermetic seal). Swollen cans may also indicate 

that not enough heat was applied during processing (underprocessing). Suspect cans 

must be returned and not offered for sale.

3-202.16 Ice.

Freezing does not invariably kill microorganisms; on the contrary, it may preserve them. 

Therefore, ice that comes into contact with food to cool it or that is used directly for 

consumption must be as safe as drinking water that is periodically tested and approved 

for consumption.

3-202.17 Shellstock, Condition.

Dirty, damaged, or dead shellstock can contaminate and degrade live and healthy 

shellstock and lead to foodborne illness. Harvesters have the primary responsibility for 

culling shellstock, but this responsibility continues throughout the distribution chain. 

3-202.18 Molluscan Shellfish, Packaging and Identification.

Accurate source identification of the harvesting area, harvester, and dealers must be 

contained on molluscan shellstock identification tags so that if a shellfish-borne disease 

outbreak occurs, the information is available to expedite the epidemiological 

investigation and regulatory action.

Retailers may see a harvester’s tag along with a dealer tag, a dealer tag alone, or a 

dual-purpose (two-sided) tag. The Model Ordinance allows a dual-purpose tag 

(harvester and dealer information on one tag). If a dual purpose tag is used (harvester 

and dealer), duplicate information is not required on both sides of the tag, and retailers 

must check the dealer side of the tag to ensure they are purchasing from an approved 

source. When a two-tag system is used the dealer tag must meet the requirements of 

the Model Ordinance for tagging. Shellstock that is harvested is required to be tagged 

by the harvester with information outlined in the Model Ordinance. This harvester tag

captures the relevant information that entities who further process and distribute the 
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Annex 3 - 86

product must retain to ensure commingling doesn’t occur and traceback can be 

completed if an outbreak occurs. As shellstock moves from harvest, through 

processing, and into commerce, an additional tag may be affixed to the container by the 

dealer. The dealer must follow the requirements in the Model Ordinance to ensure all 

required information remains on the container of shellstock. 

Plastic containers commonly used throughout the shellfish industry for shucked product 

bear specific information regarding the source of the shellfish as required by the NSSP 

Guide for the Control of Molluscan Shellfish. These containers must be nonreturnable 

so that there is no potential for their subsequent reuse by shellfish packers which could 

result in shucked product that is inaccurately identified by the label. The reuse of these 

containers within the food establishment must be assessed on the basis of the Food 

Code's criteria for multi-use containers and the likelihood that they will be properly 

relabeled to reflect their new contents.

3-202.110 Juice Treated. 

Refer to public health reason for § 3-801.11. 

Original containers and records

3-203.11 Molluscan Shellfish, Original Container.

Lot separation is critical to isolating shellfish implicated in illness outbreaks and tracking 

them to their source. Proper identification is needed for tracing the origin and 

determining conditions of shellfish processing and shipment. If the lots are commingled 

at retail, traceability is undermined and the root of the problem may remain undetected. 

If no causative factors are identified in the food establishment, tracing the incriminated 

lot helps in identifying products that need to be recalled or growing waters that may 

need to be closed to harvesting. 

When shucked shellfish are prepackaged in consumer self service containers, the 

labeling information as specified under section 3-202.18 must be recorded on a log 

sheet to correlate with the date of sale of the consumer sized containers. 

3-203.12 Molluscan Shellfish, Maintaining Identification.

Accurate records that are maintained in a manner that allows them to be readily 

matched to each lot of molluscan shellfish provide the principal mechanism for tracing 

molluscan shellfish to its original source. If an outbreak occurs, regulatory authorities 

must move quickly to close affected growing areas or take other appropriate actions to 

prevent further illnesses. Records must be kept for 90 days to allow time for hepatitis A 

virus infections, which have an incubation period that is significantly longer than other 

shellfish-borne diseases, to come to light.
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The 90 day requirement is based on the following considerations:

Shelf-life of the product............................... 14 days

Incubation period....................................... 56 days

Medical diagnosis and confirmation.................5 days

Reporting...................................................5 days

Epidemiological investigation........................10 days

Total........................................................ 90 days

In reality and as stated in the provision, the 90-day “clock” starts at the time the 

container of shellstock is emptied. Starting from the date of harvest is not correct 

because the shellstock may be sold/consumed in less than the 14 days of shelf life cited 

in the chart above. Therefore, the 90 days may expire and the tag discarded before an 

illness is reported and investigated.

Shellstock could be frozen in the food establishment during the 14-day estimated shelf 

life period, which would effectively stop the clock on the shelf life. The shellstock could 

be thawed and consumed past the 14-day shelf life. In this case, the 90 days would 

expire before consumption if the clock started 90 days from the harvest date.

Freezing shellstock in the food establishment is not usually done because, although 

oysters-in-the-shell can be frozen with fair results, they do not have the same texture 

and appearance of a fresh oyster when thawed. Commercially frozen oysters are frozen 

rapidly to retain product quality. 

3-204.10 Food Donation.

In the United States, food waste is estimated as constituting between 30-40 percent of

the food supply. This figure, based on estimates from USDA’s Economic Research 

Service of a 31 percent food loss at the retail and consumer levels, corresponds to 

approximately 133 billion pounds and $161 billion worth of food in 2010. Wasted food is 

the single largest category of material placed in municipal landfills and represents 

nourishment that could have helped feed families in need. Additionally, water, energy, 

and labor used to produce wasted food could have been employed for other purposes. 

Effectively reducing food waste will require cooperation among federal, state, tribal and 

local governments, faith-based institutions, environmental organizations, communities, 

and the entire supply chain. 

In October 2018, the U.S. Department of Agriculture (USDA), the U.S. Environmental 

Protection Agency (EPA), and the U.S. Food and Drug Administration (FDA) launched 

the Winning on Reducing Food Waste Initiative in a formal agreement and renewed 

theformal agreement in December 2020. As part of the initiative, the agencies affirmed 

their shared commitment to work towards the national goal of reducing food loss and
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waste by 50 percent by 2030. The agencies agreed to coordinate food loss and waste 

actions such as education and outreach, research, community investments, voluntary 

programs, public-private partnerships, tool development, technical assistance, event 

participation, and policy discussion on the impacts and importance of reducing food loss 

and waste. While there have been significant actions taken and commitments made 

through public-private partnerships to date, there is still much work to be done. 

The donation of food within communities is a long standing and important societal 

practice and is a critical component of reducing food loss and waste. FDA encourages 

donation of food that is stored, prepared, packaged, displayed, and labeled in 

accordance with the applicable provisions contained in the Food Code. Food prepared 

in this manner has always been permitted to be offered to consumers whether as a gift 

or offered for sale, regardless of the mechanism or means by which customers gain 

access to the food.

Preventing contamination by employees

3-301.11 Preventing Contamination from Hands.

In November 1999, the National Advisory Committee on Microbiological Criteria for 

Foods (NACMCF) concluded that bare hand contact with ready-to-eat foods can 

contribute to the transmission of foodborne illness and agreed that the transmission 

could be interrupted. The NACMCF recommended exclusion/restriction of ill food 

workers as the first preventative strategy and recognized that this intervention has 

limitations, such as trying to identify and manage asymptomatic food workers. 

The three interdependent critical factors in reducing foodborne illness transmitted 

through the fecal-oral route, identified by the NACMCF, include exclusion/restriction of ill 

food workers; proper handwashing; and no bare hand contact with ready-to-eat foods. 

Each of these factors is inadequate when utilized independently and may not be 

effective. However, when all three factors are combined and utilized properly, the 

transmission of fecal-oral pathogens can be controlled. Depending on the microbial 

contamination level on the hands, handwashing with plain soap and water, as specified 

in the Food Code, may not be an adequate intervention to prevent the transmission of 

pathogenic microbes to ready-to-eat foods via hand contact with ready-to-eat foods. 

Handwashing as specified in the Food Code will reduce microbial contamination of the 

hands by 2-3 logs. 

Food employees and conditional employees infected with fecal-oral pathogens can 

shed viral and protozoan pathogens in the feces at levels up to 108 viral particles or 

oocysts per gram of feces. Having a high potential contamination level on the hands 

combined with a very low infectious dose necessary to cause infection are the reasons 

that FDA believes that handwashing alone is not an effective single barrier in the 

transmission of these fecal-oral pathogens. The infective dose for Giardia and 

Cryptosporidium is believed to be as low as 1-10 oocysts, and as few as 10 virus 

particles can infect an individual with Norovirus or hepatitis A. 
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The CDC now estimates that Norovirus is the leading cause of foodborne illness in the 

United States. Contaminated hands are a significant factor in the transmission of enteric 

viruses, including Norovirus and hepatitis A virus. Further, contamination of food by an 

infected food worker is the most common mode of transmission of hepatitis A in 

foodborne disease outbreaks. Research has shown the viral transfer rate from 

contaminated hands to ready-to-eat food to be about 10% and that proper handwashing 

will significantly reduce the chance of transmitting pathogenic viruses. However, with 

heavy initial contamination of the hands, especially in the subungal space of the fingers, 

a basic 2-3 log reduction handwash procedure may not be adequate to prevent the 

transmission of viral foodborne illness. 

Even though bare hands should never contact exposed, ready-to-eat food, thorough 

handwashing is important in keeping gloves or other utensils from becoming vehicles for 

transferring microbes to the food. 

If a ready-to-eat food is being added as an ingredient to a food item that is subsequently 

subjected to a pathogen kill step (such as adding cheese or other ready-to-eat toppings 

to a pizza dough or adding vegetables to a raw meat dish before cooking) then strict 

prohibition of bare hand contact is not necessary. Cooking foods to the temperatures 

required in the Food Code will reduce the likelihood of survival of pathogens that might 

be transferred from an employee’s hands to the surface of the ready-to-eat foods. The 

exception specifically targets bare hand contact with ready-to-eat food at the time it is 

added as an ingredient to food that will be cooked in the food establishment to the 

minimum temperatures specified in the Food Code. The exception does not apply when 

adding ready-to-eat foods as ingredients to foods that will only be lightly heated, melted, 

or browned rather than cooked to the minimum temperatures specified in this section. 

Nor does this exception apply when adding ready-to-eat foods as ingredients to foods 

that are intended for preparation by the consumer offsite. When proper heat treatment is 

used in combination with the exclusion/restriction of ill food workers and proper 

handwashing, the proper heat treatment provides an additional means of interrupting 

disease transmission. 

Refer to the public health reasons for §§ 2-301.11, 2-301.12, and 2-301.14.

3-301.11(E) Prior Approval for Food Employees to Touch Ready-to-Eat Food 

with Bare Hands

Infected food employees are the source of contamination in approximately one in five 

foodborne disease outbreaks reported in the United States with a bacterial or viral 

cause.1 Most of these outbreaks involve enteric, i.e., fecal-oral agents. These are 

1Based on CDC Summary Surveillance for Foodborne-Disease Outbreaks – United States, 1988-1992 and New York 

State Department of Health data 1980-1991 published: Weingold, Guzewich, Fudala, 1994, Use of Foodborne 

Disease Data for HACCP Risk Assessment. J. Food Prot. 53: 820-830.
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organisms that employees were shedding in their stools at the time the food was 

prepared. Because of poor or nonexistent handwashing procedures, workers spread 

these organisms to the food. In addition, infected cuts, burns, or boils on hands can also 

result in contamination of food. Viral, bacterial, and parasitic agents can be involved. 

Traditionally, food regulations have required two methods of preventing the spread of 

foodborne disease by this mode of transfer, i.e., they have prohibited food workers from 

preparing food when they are infectious and have required thorough and frequent 

handwashing. In order to strengthen fecal-oral transmission interventions, the Food 

Code provides focused and specific guidance about ill workers and when handwashing 

must occur. As a final barrier, bare-hand contact with ready-to-eat food (i.e., food that is 

edible without washing or is not subsequently subjected to a pathogen kill step) is 

prohibited and suitable utensils such as spatulas, tongs, single-use gloves, or 

dispensing equipment are required to be used. 

Because highly susceptible populations include persons who are 

immunocompromised, the very young and the elderly, establishments serving 

these populations may not use alternatives to the no bare hand contact with 

ready-to-eat food requirement. 

Acceptability of an alternative procedure to no bare hand contact requires prior approval 

from the regulatory authority based on the food establishment having a written 

employee health policy that details how the establishment complies with management 

of ill employees as specified under sections 2-201.11 - .13 and management of 

handwashing practices as specified under Part 2-3 of the Code. The approval should 

also be based on evidence provided through written procedures and documentation that 

at least all of the following are addressed: 

(A) Personal Cleanliness, i.e., handwashing procedures, including 

frequency and methodology of handwashing that ensure food employees 

keep their hands and fingertips clean and handwashing occurs at the 

times specified in section 2-301.14, including after using the toilet and 

between tasks that may recontaminate the hands. 

(B) Hygienic Practices as specified in Part 2-4. 

(C) Employee Health regarding: 

(1) Reporting of diseases and medical conditions, and

(2) Exclusions and restrictions, i.e., that food employees and 

conditional employees report their health status as specified in 

section 2-201.11; ill food employees are restricted or excluded as 

specified in section 2-201.12; and the exclusions and restrictions 

are removed as specified in section 2-201.13;

(D) How the alternative practices and procedures will control the 

hazard through an active managerial control program. Such a 
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program includes monitoring and verifying the institution of the provisions 

described in paragraphs A-C above and satisfies the following: 

(1) The public health hazard associated with bare hand contact 

specific to the food establishment operation is identified and 

understood. The regulatory authority needs assurance that the 

permit holder recognizes that the hazard being addressed is the 

possible contamination of ready-to-eat food by viral and parasitic as 

well as bacterial pathogens that are transferred from employees’ 

hands.

(2) The ready-to-eat foods that will be contacted with bare hands 

are identified and both procedures and practices are in place so 

that food employees wash their hands before returning to their work 

station and cross-contamination from touching raw and ready-to-eat 

food is precluded. 

For example, identifying the specific type of food to be prepared, 

such as tacos, and the specific location, such as a situation where 

a food employee is assigned solely to the designated taco work 

station. The work station is located immediately adjacent to the taco 

assembly unit and the employee will be preparing only the specified 

ready-to-eat food using bare hands. 

Another example could be a food employee who is responsible 

solely for assembling a variety of ready-to-eat foods.

(3) Institution of an effective training program for food employees 

that emphasizes not working when ill with any of the 

gastrointestinal symptoms listed in the Code, and explains good 

hygienic practices, proper handwashing procedures, and safe food 

preparation procedures. This should include a documented training 

plan that specifies how management responsibility for training has 

been designated, training program content, and the frequency of 

administration including periodic refresher sessions.

(E) The alternative procedure should clearly describe monitoring, 

documentation, and verification actions to ensure that the practices and 

procedures are followed. Corrective actions need to be predetermined for 

situations where the practices and procedures are not followed, e.g., an ill 

employee is found preparing foods. 

(F) Documentation of the practices, procedures, and corrective actions 

related to an alternative to no bare hand contact with ready-to-eat food 

must be maintained and readily available at the food establishment at all 

times for use by the person in charge and for review by the regulatory 

authority.

Preventing food and ingredient contamination
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3-302.11 Packaged and Unpackaged Food – Protection Separation, 

Packaging, and Segregation. 

It is important to separate foods in a ready-to-eat form from raw animal foods during 

storage, preparation, holding and display to prevent them from becoming contaminated 

by pathogens that may be present in or on the raw animal foods. An exception is

permitting the storage and display of frozen, commercially packaged raw animal food

adjacent to or above frozen, commercially packaged ready-to-eat food or combining raw 

animal foods with ready-to-eat food as ingredients intended for future 

preparation/cooking. The freezer equipment should be designed and maintained to 

keep foods in the frozen state. Corrective action should be taken if the storage or 

display unit loses power or otherwise fails. Raw or ready-to-eat foods or commercially 

processed bulk-pack food that is packaged on-site presents a greater risk of crosscontamination. Additional product handling, drippage during the freezing process, partial 

thawing or incomplete seals on the package increase the risk of cross-contamination 

from these products packaged in-house. 

With regard to the storage of different types of raw animal foods as specified under 

subparagraph 3-302.11(A)(2), it is the intent of this Code to require separation based on 

anticipated microbial load and raw animal food type (species). Separating different 

types of raw animal foods from one another during storage, preparation, holding and 

display will prevent cross-contamination from one to the other. The required separation 

is based on a succession of cooking temperatures as specified under § 3-401.11 which 

are based on thermal destruction data and anticipated microbial load. For example, to 

prevent cross-contamination, fish and pork, which are required to be cooked to an 

internal temperature of 145°F for 15 seconds, shall be stored above or away from raw 

poultry, which is required to be cooked to an internal temperature of 165°F (<1 second, 

instantaneous) due to its considerably higher anticipated microbial load. In addition, raw 

animal foods having the same cooking temperature, such as pork and fish, shall be 

separated from one another during storage and preparation by maintaining adequate 

spacing or by placing the food in separate containers because of the potential for crosscontamination, allergen cross-contact or economic adulteration via inadvertent species 

substitution. 

Food that is inadequately packaged or contained in damaged packaging could become 

contaminated by microbes, dust, or chemicals introduced by products or equipment 

stored in close proximity or by persons delivering, stocking, or opening packages or 

overwraps. Packaging must be appropriate for preventing the entry of microbes and 

other contaminants such as chemicals. These contaminants may be present on the 

outside of containers and may contaminate food if the packaging is inadequate or 

damaged, or when the packaging is opened. The removal of food product overwraps 

may also damage the package integrity of foods under the overwraps if proper care is 

not taken.

3-302.12 Food Storage Containers, Identified with Common Name 

of Food.
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Certain foods may be difficult to identify after they are removed from their original 

packaging. Consumers may be allergic to certain foods or ingredients. The mistaken 

use of an ingredient, when the consumer has specifically requested that it not be used, 

may result in severe medical consequences. 

The mistaken use of food from unlabeled containers could result in chemical poisoning. 

For example, foodborne illness and death have resulted from the use of unlabeled salt, 

instead of sugar, in infant formula and special dietary foods. Liquid foods, such as oils, 

and granular foods that may resemble cleaning compounds are also of particular 

concern. 

3-302.13 Pasteurized Eggs, Substitute for Raw Shell Eggs for Certain 

Recipes.

Raw or undercooked eggs that are used in certain dressings or sauces are particularly 

hazardous because the virulent organism Salmonella Enteritidis may be present in 

raw shell eggs. Pasteurized eggs provide an egg product that is free of pathogens and 

is a ready-to-eat food. The pasteurized product should be substituted in a recipe that 

requires raw or undercooked eggs.

3-302.14 Protection from Unapproved Additives.

Refer to the public health reason for § 3-202.12.

Use of unapproved additives, or the use of approved additives in amounts exceeding 

those allowed by food additive regulations could result in foodborne illness, including 

allergic reactions. For example, many adverse reactions have occurred because of the 

indiscriminate use of sulfites to retard "browning" of fruits and vegetables or to cause 

ground meat to look "redder" or fresher.

The concern for misuse of additives also applies to food establishments operating under 

a variance and to Annex 6 Food Processing Criteria which addresses the use of sodium 

nitrite or other curing agents in smoking and curing operations. However, if this process 

is done incorrectly, it could cause illness or death because of excessive nitrite or 

because the food is insufficiently preserved.

3-302.15 Washing Fruits and Vegetables.

Pathogenic microorganisms, such as Salmonella spp., and chemicals such as 

pesticides, may be present on the exterior surfaces of raw fruits and vegetables. It has 

been assumed that washing removes the majority of organisms and/or chemicals 

present; however, more recent studies have demonstrated washing to fall short of their 

complete removal. Biofilm development by Salmonella allows bacterial cells to survive 

under adverse environmental conditions and also reduces the ability to remove 

pathogens by washing, even with antimicrobial agents. All fresh produce, except 

commercially washed, pre-cut, and bagged produce, must be thoroughly washed under 

running, potable water or with chemicals as specified in Section 7-204.12, or both, 
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before eating, cutting or cooking. Even if you plan to peel or otherwise alter the form of 

the produce, it is still important to remove soil and debris first.

Infiltration of microorganisms can occur through stem scars, cracks, cuts or bruises in 

certain fruits and vegetables during washing. Once internalized, bacterial pathogens 

cannot be removed by further washing or the use of sanitizing solutions. To reduce the 

likelihood of infiltration, wash water temperature should be maintained at 10°F warmer 

than the pulp temperature of any produce being washed. Because certain fruits and 

vegetables are susceptible to infiltration of microorganisms during soaking or 

submersion, it is recommended that soaking or submerging produce during cleaning be 

avoided. It is important to follow practices that minimize pathogens in the water or on 

the surface of produce. It is important that proper handwashing procedures are 

followed, in accordance with Section 2-301.12 Cleaning Procedure, before and after 

handling fresh produce.

Scrubbing with a clean brush is only recommended for produce with a tough rind or 

peel, such as carrots, cucumbers or citrus fruits that will not be bruised easily or 

penetrated by brush bristles. Scrubbing firm produce with a clean produce brush and 

drying with a clean cloth towel or fresh disposable towel can further reduce bacteria that 

may be present. Washing fresh fruits and vegetables with soap, detergent or other 

surfactants should be avoided as they facilitate infiltration and may not be approved for 

use on food. Toxic or undesirable residues could be present in or on the food if 

chemicals used for washing purposes are unapproved or applied in excessive 

concentrations. Unless otherwise stipulated in 21 CFR 173.315, chemicals used to 

wash or peel fruits and vegetables should not exceed the minimum amount required to 

accomplish the intended effect, need to be accurately tested for proper concentration, 

and must adhere to any indications as dictated on the product label. 

Many pre-cut, bagged produce items are pre-washed. If so, these products will be 

identified as such on the package label, and can be used as ready-to-eat without further 

washing. The label should also state if further washing is recommended or necessary. 

Precut or prewashed produce in open bags should not be washed before use. After 

being cut, certain produce such as melons, leafy greens and tomatoes are considered 

time/temperature control for safety food (TCS) requiring time/temperature control for 

safety and should be refrigerated at 41°F or lower to prevent any pathogens that may 

be present from multiplying. For more retail food guidance on the storage and handling 

of tomatoes, leafy greens, and other produce, you may consult the FDA Program 

Information Manual, Retail Food Protection Storage and Handling of Tomatoes, dated 

October 5, 2007, available at 

http://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/IndustryandRegulat

oryAssistanceandTrainingResources/ucm113843.htm, the document, Time as a Public 

Health Control for Cut Tomatoes, dated June 8, 2010 available at

http://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/IndustryandRegulat

oryAssistanceandTrainingResources/ucm215053.htm

and the FDA Program Information Manual, Recommendations for the Temperature 

Control of Cut Leafy Greens during Storage and Display in Retail Food Establishments
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Annex 3 - 95

dated July 7, 2010 available at 

http://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/IndustryandRegulat

oryAssistanceandTrainingResources/ucm218750.htm

On October 26, 1998 a voluntary guidance document for the produce industry which 

addresses microbial hazards and good agricultural and management practices 

commonly used by fresh fruit and vegetable producers was issued jointly by FDA, 

USDA, and CDC. This voluntary guidance contains useful information related to 

washing fruits and vegetables as well as the application of antimicrobial agents and was 

updated on August 19, 2003. This “Guide to Minimize Microbial Food Safety Hazards 

for Fresh Fruits and Vegetables”, October 26, 1998, is available from FDA’s Food 

Safety Initiative staff and also on the Internet at 

http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformatio

n/ProducePlantProducts/ucm064574.htm. 

Additionally, in February 2008, the FDA Center for Food Safety and Applied Nutrition 

(CFSAN) issued “Guidance for Industry, Guide to Minimize Microbial Food Safety 

Hazards of Fresh-cut Fruits and Vegetables,” which covers fresh-cut fruits and 

vegetables that have been minimally processed (e.g. no kill step) and altered in form, by 

peeling, slicing, chopping, shredding, coring, or trimming with or without washing or 

other treatment, prior to being packaged for use by the consumer or a retail 

establishment. This guide is available at:

http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformati

on/ProducePlantProducts/ucm064458.htm. 

On January 11, 2006 FDA/CFSAN published additional safe handling advice on the 

purchase, storage, and preparation of fresh produce, as well as Q & A’s for consumers 

on their website at: 

http://www.fda.gov/Food/ResourcesForYou/Consumers/ucm114299.htm. This 

document is available in PDF (3.5 MB) format (also available in Spanish) and provides 

additional information on the cleaning of fresh produce. 

Preventing contamination from ice used as a coolant

3-303.11 Ice Used as Exterior Coolant, Prohibited as Ingredient. 

Ice that has been in contact with unsanitized surfaces or raw animal foods may contain 

pathogens and other contaminants. For example, ice used to store or display fish or 

packaged foods could become contaminated with microbes present on the fish or 

packaging. If this ice is then used as a food ingredient, it could contaminate the final 

product. 

3-303.12 Storage or Display of Food in Contact with Ice and Water. 

Packages that are not watertight may allow entry of water that has been exposed to 

unsanitary exterior surfaces of packaging, causing the food to be contaminated. This 

may also result in the addition of water to the food that is unclaimed in the food's 

formulation and label. 
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Unpackaged foods such as fresh fish are often stored and/or displayed on ice. A 

potential for increasing the microbial load of a food exists because, as the ice melts, 

pathogens from one food may be carried by water to other foods. The potential for 

contamination is reduced by continuous draining of melting ice.

Preventing contamination from equipment, utensils, and linens

3-304.11 Food Contact with Equipment and Utensils.

Pathogens can be transferred to food from utensils that have been stored on surfaces 

which have not been cleaned and sanitized. They may also be passed on by consumers 

or employees directly, or indirectly from used tableware or food containers.

Some pathogenic microorganisms survive outside the body for considerable periods of 

time. Food that comes into contact directly or indirectly with surfaces that are not clean 

and sanitized is liable to such contamination. The handles of utensils, even if 

manipulated with gloved hands, are particularly susceptible to contamination. 

Probe-type price or identification tags are defined as a utensil. This means that if such 

tags are for multiuse, they must meet the criteria listed in Parts 4-1 Materials for 

Construction and Repair, and 4-2 Design and Construction. Probe-type price or product 

identification tags can cause microbial, chemical, or physical contamination if not 

properly designed, constructed, and maintained. 

The Food Code defines gloves as a "utensil" and therefore gloves must meet the 

applicable requirements related to utensil construction, cleaning, and storage. 

3-304.12 In-Use Utensils, Between-Use Storage. 

Refer to the public health reason for § 3-304.11. 

Once a food employee begins to use a utensil such as a ladle, spatula, or knife, that has 

been previously cleaned and sanitized, it is then considered an in-use utensil. In-use 

utensils, used on a continuous or intermittent basis during preparation or dispensing, 

must be cleaned and sanitized on a schedule that precludes the growth of pathogens 

that may have been introduced onto utensil surfaces. In-use utensils may be safely 

stored in hot water maintained at 135oF or above during intermittent use because 

microbial growth is controlled at such temperatures. 

A food utensil should be designed and used to prevent bare hand contact with ready-toeat food or to minimize contact with food that is not in a ready-to-eat form. On-site 

evaluations can be made to determine if a utensil is improperly designed for the task or 

whether a food employee is misusing an appropriately designed utensil. 

3-304.13 Linens and Napkins, Use Limitation. 

Because of their absorbency, linens and napkins used as liners that contact food must 

be replaced whenever the container is refilled. Failure to replace such liners could 

cause the linens or napkins to become fomites. 
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3-304.14 Wiping Cloths, Use Limitation. 

Soiled wiping cloths, especially when moist, can become breeding grounds for 

pathogens that could be transferred to food. Any wiping cloths that are not dry (except 

those used once and then laundered) must be stored in a sanitizer solution of adequate 

concentration between uses. Wiping cloths soiled with organic material can overcome 

the effectiveness of, and neutralize, the sanitizer. The sanitizing solution must be 

changed as needed to minimize the accumulation of organic material and sustain 

proper concentration. Proper sanitizer concentration should be ensured by checking the 

solution periodically with an appropriate chemical test kit. 

Wiping down a surface with a reusable wet cloth that has been properly stored in a 

sanitizer solution is an acceptable practice for wiping up certain types of food spills and 

wiping down equipment surfaces. However, this practice does not constitute cleaning 

and sanitizing of food contact surfaces where and when such is required to satisfy the 

methods and frequency requirements in Parts 4-6 and 4-7 of the Food Code. 

The same is true of the practice of wiping down a surface using dry disposable towels 

and a spray bottle containing pre-mixed sanitizing solution. This practice is not 

prohibited, however it alone does not constitute proper cleaning and sanitizing of food 

contact surfaces where and when such is required to satisfy the methods and frequency 

requirements in Parts 4-6 and 4-7 of the Food Code.

Further, for the purpose of wiping up food spills from surfaces in situations where full 

cleaning and sanitizing is not required (such as when a soft drink overflows onto the 

side of a cup or onto a countertop) the use of dry cloths and disposable towels is also 

acceptable as long as the cloth or towel is used for no other purpose. Again, this does 

not constitute a proper cleaning and sanitizing procedure for a food contact surface, 

when such is called for in 4-6 and 4-7 of the Food Code.

In order to effectively clean and sanitize food contact surfaces, where and when 

required to satisfy the requirements in Parts 4-6 and 4-7 of the Food Code, the surface 

must be first cleaned properly to remove organic material. In most cases this requires 

use of detergents or other cleaners such as described in Section 4-603.14 of the Food 

Code. After the surface is clean to sight and touch, a sanitizing solution of adequate 

temperature with the correct chemical concentration should then be applied to the 

surface. The sanitizing solution must stay on the surface for a specific contact time as 

specified in this Code and in accordance with the manufacturer’s EPA-registered label, 

as applicable.

3-304.15 Gloves, Use Limitation. 

Refer to the public health reason for § 3-304.11. 

Gloves used in touching ready-to-eat food are defined as a "utensil" and must meet the 

applicable requirements related to utensil construction, good repair, cleaning, and 

storage. 
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Multiuse gloves, especially when used repeatedly and soiled, can become breeding 

grounds for pathogens that could be transferred to food. Soiled gloves can directly 

contaminate food if stored with ready-to-eat food or may indirectly contaminate food if 

stored with articles that will be used in contact with food. Multiuse gloves must be 

washed, rinsed, and sanitized between activities that contaminate the gloves. Hands 

must be washed before donning gloves. Gloves must be discarded when soil or other 

contaminants enter the inside of the glove. 

Slash-resistant gloves are not easily cleaned and sanitized. Their use with ready-to-eat 

foods could contaminate the food. 

Natural Rubber Latex (NRL) Gloves

Natural rubber latex gloves have been reported to cause allergic reactions in some 

individuals who wear latex gloves during food preparation, and even in individuals 

eating food prepared by food employees wearing latex gloves (refer to Annex 2, 

3-304.15). This information should be taken into consideration when deciding whether 

single-use gloves made of latex will be used during food preparation. 

Although many allergic reactions occur as a result of occupational exposure, CFSAN is 

actively reviewing its current policy on the use of disposable NRL gloves in food 

operations in light of the possible transmission of the latex protein via food. To gain 

additional information regarding allergic reactions allegedly due to the ingestion of food 

contaminated by NRL in retail settings, CFSAN has been collecting reports of such 

reactions from consumers who have contacted the Agency. Several offices within 

CFSAN will continue to collaborate in reviewing incoming data. The results of these 

activities and other related efforts will be used to determine if policy changes regarding 

the use of latex in food operations, based on food safety considerations, are warranted. 

The FDA, Office of Food Additive Safety, Division of Food Contact Notification, reviews 

gloves submitted for food-contact use in the food industry on the basis of the glove’s

formulation or components. FDA regulates NRL gloves used for medical purposes only. 

FDA is aware of the following information related to occupational hazards (not food 

safety hazards) associated with the use of NRL gloves: 

• The National Institute for Occupational Safety and Health (NIOSH) published a 

1997 Alert titled "Preventing Allergic Reactions to Natural Rubber Latex in the 

Workplace" (NIOSH publication number 97-135) which is found at 

http://www.cdc.gov/niosh/docs/97-135/. 

• The American College of Allergy, Asthma and Immunology (ACAAI) and the 

American Academy of Allergy Asthma and Immunology (AAAAI) issued a joint 

statement discouraging the routine use of NRL gloves by food handlers. (1997) 

http://www.acaai.org/public/physicians/joint.htm. 

o The AAAAI provides information on latex allergies on the web at 

http://www.aaaai.org/patients/allergic_conditions/latex_allergy.stm. 
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o The ACAAI provides information on latex allergies on the web at 

http://www.acaai.org/public/facts/latex.htm. 

• An OSHA Technical Information Bulletin recommends reducing allergy potential 

by reducing unnecessary exposure to NRL. Stating "Food service workers ... do 

not need to use NRL gloves for food handling..." (1999) 

http://www.latexallergylinks.org/LA-TIB.html. 

OSHA addresses gloves in the following Federal regulation, which can be found at: 

http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_i

d=9788. 

OSHA Regulations (Standards - 29 CFR)

Standard Number: 1910.138 

Standard Title: Hand Protection. 

SubPart Number: I 

SubPart Title: Personal Protective Equipment 

(a) General requirements. Employers shall select and require employees 

to use appropriate hand protection when employees' hands are exposed 

to hazards such as those from skin absorption of harmful substances; 

severe cuts or lacerations; severe abrasions; punctures; chemical burns; 

thermal burns; and harmful temperature extremes. 

(b) Selection. Employers shall base the selection of the appropriate hand 

protection on an evaluation of the performance characteristics of the hand 

protection relative to the task(s) to be performed, conditions present, 

duration of use, and the hazards and potential hazards identified. 

3-304.16 Using Clean Tableware for Second Portions and Refills. 

Refer to the public health reason for § 3-304.11.

3-304.17 Refilling Returnables. 

Food establishments may provide multi-use to-go containers to consumers with the 

intention that the containers are to be returned to the food establishment for refilling or 

reuse. These containers are likely to be soiled when the consumer returns the container 

to the food establishment. As a result, pathogens may be transferred to food by 

consumers or employees directly, or indirectly, from used take-home food containers. 

The existing provisions in the Food Code, specifically the cleaning and sanitization 

provisions in Parts 4-6 and 4-7, if carried out properly upon return of a used container, 

are sufficient to ensure that the container is safe to refill or reuse if performed in 

conjunction with a visual inspection by a food employee to verify that the container still 

meets the intent of the provisions in Parts 4-1 and 4-2. Reusing single-service and 

single-use articles is prohibited by the Food Code.

The refilling of consumer-owned, personal take-out beverage containers, such as 

thermally insulated bottles, nonspill coffee cups, and promotional beverage glasses, by 

a consumer or food employee introduces the possibility of contamination of the filling 
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 100

equipment or product by improperly cleaned containers or the improper operation of the 

equipment. To prevent this contamination and possible health hazards to the consumer, 

the refilling of consumer-owned, personal take-out beverage containers is limited to 

beverages that are not potentially hazardous (time/temperature control for safety) foods. 

Equipment must be designed to prevent the contamination of the equipment and means 

must be provided to clean the containers at the facility.

Preventing contamination from the premises

3-305.11 Food Storage.

3-305.12 Food Storage, Prohibited Areas. 

Pathogens can contaminate and/or grow in food that is not stored properly. Drips of 

condensate and drafts of unfiltered air can be sources of microbial contamination for 

stored food. Shoes carry contamination onto the floors of food preparation and storage 

areas. Even trace amounts of refuse or wastes in rooms used as toilets or for dressing, 

storing garbage or implements, or housing machinery can become sources of food 

contamination. Moist conditions in storage areas promote microbial growth.

Refer also to the public health reasons for § 2-501.11.

3-305.13 Vended Time/Temperature Control for Safety Food, Original 

Container.

The possibility of product contamination increases whenever food is exposed. Changing 

the container(s) for machine vended time/temperature control for safety food allows 

microbes that may be present an opportunity to contaminate the food. Pathogens could 

be present on the hands of the individual packaging the food, the equipment used, or 

the exterior of the original packaging. In addition, time/temperature control for safety 

foods are vended in a hermetically sealed state to ensure product safety. Once the 

original seal is broken, the food is vulnerable to contamination. 

3-305.14 Food Preparation. 

Food preparation activities may expose food to an environment that may lead to the 

food's contamination. Just as food must be protected during storage, it must also be 

protected during preparation. Sources of environmental contamination may include 

splash from cleaning operations, drips form overhead air conditioning vents, or air from 

an uncontrolled atmosphere such as may be encountered when preparing food in a 

building that is not constructed according to Food Code requirements.
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Preventing contamination by consumers

3-306.11 Food Display.

During display, food can be contaminated even when there is no direct hand contact. 

Many microbes can be conveyed considerable distances on air currents through fine 

sprays or aerosols. These may originate from people breathing or sneezing, water 

sprays directed at drains, or condensate from air conditioners. Even wind gusts across 

sewage deposits and fertilized fields have been known to contaminate food in adjacent 

establishments where food was unprotected.

3-306.12 Condiments, Protection.

Unpackaged condiments are exposed to contamination by consumers who could be 

suffering from a disease transmissible through food. Once the condiments are 

contaminated, subsequent consumers using the condiments may be exposed to 

pathogens. Condiments in individual packages are protected from consumer 

contamination.

On- or off-site facilities for refilling condiment dispensers must be adequately equipped 

to ensure that the filling operation does not introduce contaminants.

3-306.13 Consumer Self-Service Operations.

Raw foods of animal origin usually contain pathogens. In addition, these foods, if offered 

for consumer self-service, could cross contaminate other foods stored in the same 

display. Because raw foods of animal origin are assumed to be contaminated and do 

provide an ideal medium for the growth of pathogenic organisms, they should not be 

available for consumer self-service. Self-service operations of ready-to-eat foods also 

provide an opportunity for contamination by consumers. The risk of contamination can 

be reduced by supplying clean utensils and dispensers and by employee monitoring of 

these operations to ensure that the utensils and dispensers are properly used.

Bean sprouts that are displayed in produce areas for consumer self-service are 

time/temperature control for safety foods and appropriate refrigeration must be 

maintained. However, they are not considered ready-to-eat since they are intended to 

be washed by the consumer before consumption. 

3-306.14 Returned Food and Re-Service or Sale.

Food can serve as a means of person-to-person transmission of disease agents such 

as hepatitis A virus. Any unpackaged foods, even bakery goods in a bread basket that 

are not time/temperature control for safety foods and that have been served to a 

consumer, but not eaten, can become vehicles for transmitting pathogenic 

microorganisms from the initial consumer to the next if the food is served again. 
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Preventing contamination from other sources

3-307.11 Miscellaneous Sources of Contamination. 

This Code section provides a category in which to capture sources of contamination not 

specifically delineated in Subparts 3-301 through 306. Codes prior to 1993 had such a 

provision for addressing food contamination for reasons other than those elsewhere 

specified. Regardless of its specificity, a Code can not anticipate all the diverse means 

by which food can become contaminated after receipt. 

Cooking

3-401.11 Raw Animal Foods.

3-401.12 Microwave Cooking.

3-401.13 Plant Food Cooking for Hot Holding. 

Cooking, to be effective in eliminating pathogens, must be adjusted to a number of 

factors. These include the anticipated level of pathogenic bacteria in the raw product, 

the initial temperature of the food, and the food's bulk which affects the time to achieve 

the needed internal product temperature. Other factors to be considered include postcooking heat rise and the time the food must be held at a specified internal temperature. 

Greater numbers and varieties of pathogens generally are found on poultry than on 

other raw animal foods. Therefore, a higher temperature, in combination with the 

appropriate time is needed to cook these products. 

To kill microorganisms, food must be held at a sufficient temperature for the specified

time. Cooking is a scheduled process in which each of a series of continuous

time/temperature combinations can be equally effective. For example, in cooking a 

beef roast, the microbial lethality achieved at 112 minutes after it has reached 54.4°C

(130°F) is the same lethality attained as if it were cooked for 4 minutes after it has

reached 62.8°C (145°F). Cooked beef and roast beef, including sectioned and formed

roasts, chunked and formed roasts, lamb roasts and cooked corned beef can be

prepared using one of the time and temperature combinations listed in the chart in

§ 3-401.11 to meet a 6.5-log10 reduction of Salmonella. The stated temperature is

the minimum that must be achieved and maintained in all parts of each piece of meat

for a least the stated time. The source of the time and temperature parameters is

from the USDA/FSIS Appendix A. Compliance Guidelines For Meeting Lethality

Performance Standards For Certain Meat And Poultry Products can be found at: 

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

Cooking requirements are based in part on the biology of pathogens. The thermal 

destruction of a microorganism is determined by its ability to survive heat. Different 

species of microorganisms have different susceptibilities to heat. Also, the growing 

stage of a species (such as the vegetative cell of bacteria, the trophozoite of protozoa, 

or the larval form of worms) is less resistant than the same organism's survival form (the 

bacterial spore, protozoan cyst, or worm egg).
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Food characteristics also affect the lethality of cooking temperatures. Heat penetrates 

into different foods at different rates. High fat content in food reduces the effective 

lethality of heat. High humidity within the cooking vessel and the moisture content of 

food aid thermal destruction. 

Heating a large roast too quickly with a high oven temperature may char or dry the 

outside, creating a layer of insulation that shields the inside from efficient heat 

penetration. To kill all pathogens in food, cooking must bring all parts of the food up to 

the required temperatures for the correct length of time. 

The temperature and time combination criteria specified in Part 3-4 of this Code are 

based on the destruction of Salmonellae. This organism, if present in raw shell eggs, is 

generally found in relatively low numbers. Other foods, uncomminuted fish and meats 

including commercially raised game animal meat, specified as acceptable for cooking at 

this temperature and time parameter are expected to have a low level of internal 

contamination. The parameters are expected to provide destruction of the surface 

contaminants on these foods. Part 3-4 includes temperature and time parameters that 

provide "D" values (decimal log reduction values) that may surpass 7D. For example, at 

63oC(145oF), a time span of 15 seconds will provide a 3D reduction of Salmonella

Enteritidis in eggs. 

The requirements specified under ¶ 3-401.11(D) acknowledge the rights of an informed 

consumer to order and consume foods as preferred by that consumer based on the 

consumer’s health status and understanding of the risks associated with eating raw or 

partially-cooked animal foods. 

In consumer self-service operations, such as buffets, salad bars, sushi bars, or display 

cases, the consumer advisory as specified under section 3-603.11 must be posted or 

available at the self-service unit where the raw or partially cooked food is held for 

service and readily accessible to consumers prior to making their food selections. In a 

catered situation, such as a wedding reception, guests are responsible for making their 

own requests or selections.

Slow-cooked roasts - heating deviations and slow come up time

(Source: USDA/FSIS Cooking Guideline for Meat and Poultry Products (Revised 

Appendix A) found at https://www.fsis.usda.gov/guidelines/2021-0014.)

Heating deviations, which most often involve a slow heating come-up time (CUT) or an

inordinate dwell time within the optimum temperature range for microorganism growth 

(e.g., product remains at temperatures between 50oF and 130oF for more than 6 

hours) can foster the multiplication of many pathogens. This multiplication sometimes

can be so prodigious that even recooking may be ineffective in rendering the product

safe. Also, certain toxigenic bacteria can release toxins into the product. Some of

these toxins, such as those of Staphylococcus aureus (S. aureus), are extremely

heat stable and are not inactivated by normal recooking temperatures. This pathogen 

is the main food safety concern during long heating CUT. The establishment should 
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support the total time product temperature is between 50oF and 130oF is 6 hours or 

less.

When cooking products to lethality, deviations may occur due to; the establishment 

failing to meet a time-temperature parameter in its lethality critical control point (CCP) 

(Type 1), the establishment failing to maintain sufficient humidity during the cooking 

step (Type 2), or a slow heating CUT allowed product to remain at temperatures that 

allow pathogen growth (Type 3). See additional information in Cooking Guideline for 

Meat and Poultry Products (Revised Appendix A) found at 

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

Establishments should carefully evaluate each deviation as each situation is unique 

and needs to be evaluated individually. To support safe release of the product, every 

hazard associated with the type of heating deviation identified must be controlled. If 

any single hazard is not controlled, then product should be destroyed.

Seared Steak

The provision for allowing seared steaks was reviewed by the National Advisory 

Committee on Microbiological Criteria for Foods (NACMCF) and USDA. 

USDA comments included at the time, “For the purposes of this discussion, steak is a 

whole beef muscle. It does not include whole beef muscle that has been pinned, 

injected, or chopped and formed. It may be cut cross grain, such as sirloin, chuck, or 

porterhouse; or it may be cut with the grain, such as flank, skirt, or Chateaubriand. 

Other species, such as poultry, pork, and lamb are not included.” 

NACMCF comments included, “Due to the low probability of pathogenic organisms 

being present in or migrating from the external surface to the interior of beef muscle, 

cuts of intact muscle (steaks) should be safe if the external surfaces are exposed to 

temperatures sufficient to effect a cooked color change. In addition, the cut (exposed) 

surfaces must receive additional heat to affect a complete sear across the cut surfaces. 

Grill or char marks may be applied to the complete surface searing. The meat should be 

seared on both top and bottom surfaces utilizing a heating environment (e.g., grill or 

broiling oven) that imparts a temperature at the surface of the intact steak of at least 

145oF to achieve a cooked color change on all external surfaces. The searing of all 

surfaces should be continuous until the desired degree of doneness and appearance 

are attained. This is considered a ready-to-eat food.” 

As reflected in the updated definition of “intact meat”, steaks that may be cooked 

without a consumer advisory are those from a cut of whole muscle(s) MEAT that has 

not undergone COMMINUTION, MECHANICAL TENDERIZATION (including 

INJECTION), vacuum tumbling with solutions, reconstruction, cubing, or pounding. 

The definition of “intact meat” was revised to clarify all of the ways that beef steaks are 

not considered intact meats including if they are vacuum tumbled with solutions. The 

definition of "Mechanically tenderized" has also been updated to be consistent with the 

USDA FSIS description of “mechanically tenderized” in the 2015 final rule titled 

Descriptive Designation of Needle- or Blade-Tenderized (Mechanically Tenderized) 
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Beef Product (80 FR 28153). The rule established labeling requirements for raw or 

partially cooked mechanically tenderized beef products and clarified that products 

injected with a marinade or solution are considered mechanically tenderized (CFP 

Issue 2018-I-013). The updated definition also includes scoring and marination as a 

means of mechanical tenderization that would make a steak non-intact. Marination is 

a food safety concern when the fascia (exterior surface) of the steak is broken by 

scoring or other means which allows the marinade to penetrate, and potentially 

contaminate, the interior of the steak. In such cases, the allowance for undercooking 

without a consumer advisory is negated.

Pork

In pork, Trichinella spiralis, Toxoplasma gondii, and Taenia solium, parasites 

causing foodborne illness, are inactivated at temperatures below 145oF. Therefore, pork 

roasts can be cooked like beef roasts (e.g., 145oF for 3 minutes) and pork chops 

cooked like steaks to achieve an internal temperature of 145oF for 15 seconds. 

Based on the Goodfellow and Brown study, a 5D reduction of organisms is achieved at 

68oC (155oF) for 17 seconds for the following foods: ratites and injected meats and 

comminuted: fish, meat, game animals commercially raised for food, and game animals 

that come under a USDA voluntary inspection program. Ratites such as ostrich, emu, 

and rhea are included in this list of raw animals foods because when cooked to a 

temperature greater than 68oC (155oF), ratites exhibit a (metallic) "off" taste. 

When USDA established the time and temperature parameters for 9 CFR 318.23 HeatProcessing and Stabilization Requirements for Uncurred Meat Patties (known as the 

"patty rule"), the Agency based the 5D for Salmonella on extrapolations applied to the 

research done by Goodfellow and Brown to account for the lack of a "come up, come 

down" time in the thin, small mass beef patties. Consequently, there is no linear 

relationship between the patty rule and roast beef time and temperature parameters. 

The patty rule also provided for an 8D reduction in the number of Shiga toxin-producing 

Escherichia coli. The time and temperature requirements in the Food Code for 

comminuted meats are comparable to the USDA requirements.

Temperature for Comminuted Meat at Less Than 1 Second

In the "Report of the Task Force on Technical Issues Arising from the National Advisory 

Committee on Microbiological Criteria for Foods” (NACMCF) Review of the Meat Patty 

Proposal" (undated), it is stated on page 7, in Option (A), that: 

“Based on the 1998 research data ... and an assumption that instantaneous is defined 

as eight seconds, manufacturers would be required to process fully-cooked meat patties 

at a temperature of 157oF. Given the lack of any significant margin of safety in this 

process, there should be no deviation below the 158oF requirement.” 

In November, 1997, the NACMCF Meat and Poultry Subcommittee revisited the time 

and temperatures for cooking hamburger and advised FDA that cooking hamburger to 

158oF for less than one second is an adequate cook based on the following: 
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1. The cooking recommendations contained in the Food Code and in USDA 

guidance provide a large margin of safety for killing vegetative enteric 

pathogens;

2. The concept of integrated lethality (the kill imparted during the entire heating 

and cooling process) adds to the margin of safety; and

3. The time component of the time and temperature requirement will be 

exceeded before the temperature can be determined. 

The parameters for cooking poultry, wild game animal meats, stuffed food products, 

etc., of 74oC (165oF) or above for <1 second (instantaneous) yield greater than a 7D 

reduction. 

Children’s Menu

The 2005 FDA Food Code Section 3-401.11 (D) “Raw Animal Foods” allows operators 

to serve raw or partially cooked animal food items on their customer’s request, as long 

as the establishment does not serve a “Highly Susceptible Population” and the 

customer is informed of the risks associated with consuming undercooked items.

The definition of “Highly Susceptible Population” however, only includes young children 

who are of pre-school age and who obtain food under custodial care (as from a child 

daycare center). This definition does not address pre-school and older children eating in 

retail food establishments (such as restaurants), where it is common practice to offer 

menu items intended for children (e.g. “Kids Menu”). 

The Food Code seeks to increase current protection of children beyond custodial care 

facilities and establish needed safeguards in all retail food establishments. The

importance of this issue can be demonstrated for numerous combinations of raw animal 

foods and associated pathogens. The greatest impact on children however, is 

undercooked ground beef, where the specific organism of concern is Escherichia coli

O157:H7.

Children are at relatively high risk for infection with E.coli O157:H7. It is possibly the 

leading cause of acute kidney failure and Hemolytic Uremic Syndrome (HUS) in children 

[10]. Infection with E. coli O157:H7 can result with mild to severe symptoms such as: 

non-bloody or bloody diarrhea to HUS, which is a condition that includes destruction of 

red blood cells, problems with blood clotting and kidney failure. About 2% to 20% of 

patients that are infected with E. coli O157:H7 develop HUS [6]. The risk of illness from 

E. coli O157:H7 in ground beef has been shown to be about 2.5 times higher for 

preschool children and infants than for the rest of the population [6]. The CDC has 

reported the following E. coli 0157:H7 infection rates per 100,000 by age range: 8.2 for 

young children 1-9 years old and 3.0 for older children 10-20 years of age [4]. 

Precluding undercooked foods from being offered on a children’s menu may result in 

increased protection to children from foodborne illness, particularly E. coli O157:H7, 

which can result in severe consequences in children. 
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3-401.12 Microwave Cooking.

The rapid increase in food temperature resulting from microwave heating does not 

provide the same cumulative time and temperature relationship necessary for the 

destruction of microorganisms as do conventional cooking methods. In order to achieve 

comparable lethality, the food must attain a temperature of 74oC (165oF) in all parts of 

the food. Since cold spots may exist in food cooking in a microwave oven, it is critical to 

measure the food temperature at multiple sites when the food is removed from the oven 

and then allow the food to stand covered for two minutes post microwave heating to 

allow thermal equalization and exposure. Although some microwave ovens are 

designed and engineered to deliver energy more evenly to the food than others, the 

important factor is to measure and ensure that the final temperature reaches 74oC 

(165oF) throughout the food. 

"The factors that influence microwave thermal processes include many of the same 

factors that are important in conventional processes (mass of objects, shape of objects, 

specific heat and thermal conductivity, etc.). However, other factors are unique in 

affecting microwave heating, due to the nature of the electric field involved in causing 

molecular friction. These factors are exemplified by moisture and salt contents of foods, 

which play a far more important role in microwave than conventional heating." 

(Reference: Heddelson and Doores, see Annex 2) 

3-401.13 Plant Food Cooking for Hot Holding.

Fruits and vegetables that are fresh, frozen, or canned and that are heated for hot 

holding need only to be cooked to the temperature required for hot holding. These foods 

do not require the same level of microorganism destruction as do raw animal foods 

since these fruits and vegetables are ready-to-eat at any temperature. Cooking to the 

hot holding temperature of 57°C (135°F) prevents the growth of pathogenic bacteria that 

may be present in or on these foods. In fact, the level of bacteria will be reduced over 

time at the specified hot holding temperature. 

3-401.14 Non-Continuous Cooking of Raw Animal Foods.

Close attention must be paid to control of biological hazards when a food establishment 

cooks raw animal foods using a process in which the food is partially cooked then 

cooled with the expectation of fully cooking the food at a later date or time. Section 

3-401.14 requires that establishments wishing to use a non-continuous process for the 

cooking of raw animal foods establish and follow a written plan that ensures each stage 

of the process is completed within time and temperature parameters that adequately 

prevent pathogen survival and growth. Section 3-401.14 also requires that 

establishments take special precautions to ensure that raw animal foods that have only 

been initially heated to temperatures that are not lethal to the pathogens of concern are 

clearly identified so that they will not be inadvertently sold or served to the consumer in 

a partially cooked state. 

To ensure the food does not dwell for extended periods within temperature ranges that 

favor pathogen growth, § 3-401.14 establishes limits on the time permitted to initially 
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heat the food (initial “come-up” time) and the time permitted to cool the product to 

temperatures that are safe for refrigerated storage. Together, these limits should 

prevent food from remaining at temperatures at which pathogen growth to harmful 

levels may occur.

The criteria in § 3-401.14 were developed with consideration of the United States 

Department of Agriculture/Food Safety and Inspection Service (USDA/FSIS) 

Performance Standards for Partially Cooked and Char-Marked Meat Patties and 

Partially Cooked Poultry Breakfast Strips found in 9 CFR 318.23 and 9 CFR 381.150. 

(http://edocket.access.gpo.gov/cfr_2008/janqtr/pdf/9cfr318.23.pdf, 

http://www.access.gpo.gov/nara/cfr/waisidx_08/9cfr381_08.html) 

The maximum one hour time limit for the initial heating stage was established based on 

estimates from predictive microbial modeling. It is intended to limit the cumulative 

growth of Clostridium perfringens that may occur during the come-up time and the 

subsequent cooling of the product in accordance with the requirements in 

¶ 3-501.14(A). Unless properly controlled, processes in which animal foods are heated 

to sub-lethal temperatures and times and then cooled may create an environment for 

the growth of Clostridium perfringens, Clostridium botulinum and other spore 

forming, toxigenic bacteria. 

The product temperature achieved during the initial heating process may not be 

sufficient to destroy vegetative cells of Clostridium botulinum, Clostridium 

perfringens, and Bacillus cereus, if present. The concern is the generation of a large 

number of vegetative cells of Clostridium perfringens and/or Clostridium botulinum

before the final cooking stage. For Clostridium botulinum, if enough vegetative cells 

are produced, toxigenesis can occur in the product before the product is fully cooked. 

The toxin is not destroyed at the minimum required cooking temperatures. For 

Clostridium perfringens, if a large number of vegetative cells are consumed, illness 

can result. In either case a high number of vegetative cells may challenge the lethality 

step of the ultimate cooking process to the extent that it will be unable to completely 

eliminate all of these vegetative cells. The cumulative growth of these bacterial 

pathogens must be taken into account during both the initial heating and cooling steps. 

The hazard may be compounded with an extended initial “come-up” time and/or a 

prolonged cooling stage. Hence the degree of hazard may be dependent upon the 

ultimate effect of the initial heating and cooling, as well as the final cooking step. 

A full and adequate cook during the final cooking step is of critical importance to ensure 

destruction of any pathogens that may have survived and proliferated during any initial 

heating and cooling stages of the non-continuous cooking process. Section 3-401.14 

requires that animal foods cooked by a non-continuous cooking process achieve a 

minimum final cook temperature that heats all parts of the food to a temperature and for 

a time specified under ¶¶3-401.11 (A)-(C). This requirement also precludes serving 

animal foods that have undergone non-continuous cooking in an undercooked or raw 

state. In other words, animal foods cooked using a non-continuous process are not 

covered in the exceptions provided for in ¶ 3-401.11(D) that allow for serving 
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Annex 3 - 109

undercooked animal foods upon consumer request and with an adequate consumer 

advisory.

Section 3-401.14 requires that an establishment using non-continuous cooking 

processes also establish procedures for identifying foods that have only been partially 

cooked and cooled. This is necessary to ensure these foods are not mistaken by food 

workers for foods that have been fully cooked and therefore ready-to-eat without a full 

cook. Partially cooked foods may appear to be fully cooked. 

Requiring that food establishments obtain prior approval by the regulatory authority 

before employing non-continuous cooking processes will help to ensure that the 

establishment has the proper procedures in place, as well as the necessary facilities 

and capacity to monitor the appropriate cooling, cooking, separation and product 

identification of the foods. in accordance with the requirements.

3-401.15 Manufacturer Cooking Instructions.

The incidence rate for listeriosis has changed little over the years, despite industry 

efforts to control Listeria monocytogenes in ready-to-eat (RTE) foods. Foods that are 

not ready-to-eat (NRTE foods) are rarely associated with foodborne listeriosis, even if 

contaminated with L. monocytogenes, because cooking is an effective control measure 

to reduce the risk of foodborne listeriosis. NRTE foods may also be contaminated with 

other pathogens such as Salmonella. Many manufacturers who intend for their food 

products to be consumed only after cooking provide cooking instructions on the product 

label. Food manufacturers that provide cooking instructions on the label or in labeling 

for their food products, without also providing suggestions for how to use the food 

product without cooking, generally intend that their food products are NRTE foods that 

should be consumed only after cooking and that cooking may be necessary to prevent 

foodborne illness. Frozen vegetables are an example of a food that often bears cooking 

instructions and are often intended for use only after cooking. Frozen vegetables also 

are an example of a food that has been linked to foodborne listeriosis, possibly as a 

result of failure to cook the food. Like consumers, retail and food service operations 

sometimes use frozen vegetables in making RTE foods such as salads and smoothies, 

or retail and food service operations may provide frozen vegetables such as peas and 

corn on salad bars. If L. monocytogenes is present in a frozen vegetable, and the frozen 

vegetable is thawed and prepared for use as an RTE food without cooking and this food 

is held refrigerated, the L. monocytogenes could multiply during refrigerated storage 

and potentially cause illness. Similarly, Salmonella can be present in NRTE foods 

provided to retailers with cooking instructions (e.g., raw agricultural commodities in 

uncooked prepared foods); failure to follow cooking instructions can result in foodborne 

salmonellosis. 

At the retail level, there is no requirement that foods (other than raw animal foods) be 

fully cooked prior to human consumption. FDA regulation (Current Good Manufacturing 

Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; 21 

CFR Part 117) allows a food manufacturer that produces a food (such as a spice or 

spice/seasoning blend) that has a known or reasonably foreseeable hazard (such as 
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 110

Salmonella) to provide that food to a customer such as a retail food establishment 

without first processing the food to control that hazard, as long as the manufacturer 

discloses to the retail food establishment that the food has not been processed to 

control the hazard. Food establishments need to be aware that food that bears such 

disclosures must be processed (by cooking) to control the hazard prior to making the 

food available for human consumption. The cooking times and temperatures for foods 

that are received with such a disclosure will vary depending on the food and how it will 

be used. For example, a spice blend that is added to meat, poultry or fish would be 

cooked to a time and temperature appropriate for that food, as required by §3-401.11 in 

the Food Code. If used in a food for which the Food Code does not specify a 

temperature the food cooking times and temperatures that have been commonly 

applied to a type of food can be used (e.g., heating spiced apple cider to boiling).

Freezing

3-402.11 Parasite Destruction.

Refer to the public health reason for § 3-201.11. 

Lightly cooked, raw, raw-marinated, and cold-smoked fish may be desired by 

consumers for taste or perceived nutritional reasons. In order to ensure destruction of 

parasites, fish may be frozen before service as an alternative public health control to 

that which is provided by adequate cooking. Candling or other visual inspection 

techniques are not adequate to avoid the risk of parasites from fish which have not been 

frozen. 

The recommended control strategies refer to the ambient air temperature during 

freezing and to the length of time that the fish is held at the appropriate freezer 

temperature, or the length of time that the fish is held after it is solid frozen, whichever it 

appropriate. The parasite hazard is not considered to be reasonably likely to occur if the 

finished product is fish eggs that have been removed from the skein (the tissue that 

contains the egg mass) and rinsed. 

In response to information provided to the FDA Office of Seafood, the Fish and 

Fisheries Products Hazards and Controls Guidance lists certain species of tuna as not 

being susceptible to parasites of concern and therefore exempted from the freezing 

requirements that apply to other fish species that are consumed raw. 

The Fish and Fisheries Products Hazards and Controls Guidance states that species 

that normally have parasites as a result of consuming infected prey, apparently do not 

have the same parasite hazard when raised on pelleted food in an aquaculture 

operation. On the other hand, aquacultured fish that are fed processing waste and bycatch fish may have a parasite hazard, even when wild caught fish of that species do 

not normally have a parasite hazard. Feed must not contain any live parasites. For 

example, the use of fresh fish meat in feed could transmit such parasites. Only heat 

treated feed or feed otherwise produced in a manner that would kill parasite 

intermediate stages infective to the aquacultured fish, such as most pelleted feeds, 

should be used. 
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Additionally, it should be noted that the Fish and Fisheries Products Hazards and 

Controls Guidance, Edition 4, Tables 3-2 and 3-3 (Chapter 3) lists those species for 

which FDA has information that a potential parasite hazard exists. Fish species in 

Tables 3-2 and 3-3 that do not have specific parasite hazards listed are not necessarily 

safe when consumed raw or undercooked. This is because fish species in Tables 3-2 

and 3-3 were not listed with a parasite hazard if the species were generally cooked 

before consumption. In addition, in some cases, there is insufficient information or data 

to be able to denote a specific parasite hazard or deem the species as naturally 

parasite-free. The exemptions to freezing as specified in ¶ 3-402.11(B) of the Food 

Code are inclusive of and in harmony with the information and recommendations 

provided in the Fish and Fisheries Products Hazards and Controls Guidance.

Based on FDA’s current assessment, parasites are not considered a significant hazard 

in molluscan shellfish or in scallop products consisting only of the shucked abductor 

muscle. Therefore these products are not required to be subject to the parasite 

destruction procedures specified under ¶3-402.11(A) prior to sale or service in a raw or 

partially cooked form.

Based on FDA’s current assessment, parasites are not considered a significant hazard 

in molluscan shellfish or in scallop products consisting only of the shucked abductor 

muscle. Therefore these products are not required to be subject to the parasite 

destruction procedures specified under ¶3-402.11(A) prior to sale or service in a raw or 

partially cooked form.

3-402.12 Records, Creation and Retention.

Records must be maintained to verify that the critical limits required for food safety are 

being met. Records provide a check for both the operator and the regulator in 

determining that monitoring and corrective actions have taken place. 

While the Country of Origin Labeling requirements, http://www.ams.usda.gov/COOL/

effective Sept. 30, 2004, mandate identification of wild and farm-raised fish and 

shellfish, the requirements do not address contents of pelleted feed used in the 

aquaculture operation. Documentation must be available in the food establishment from 

the source-through-purchase specifications or labeling that pelleted feed used did not 

contain fresh fish or plankton. Follow the guidance provided in the Fish and Fisheries 

Products Hazards and Controls Guidance, Table #3-1 – Potential Vertebrate Species 

Related Hazards and Table #3-2 – Potential Invertebrate Species Related Hazards. 

Reheating

3-403.11 Reheating for Hot Holding.

When food is held, cooled, and reheated in a food establishment, there is an increased 

risk from contamination caused by personnel, equipment, procedures, or other factors. 

If food is held at improper temperatures for enough time, pathogens have the 

opportunity to multiply to dangerous numbers. Proper reheating provides a major 

degree of assurance that pathogens will be eliminated. It is especially effective in 
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Annex 3 - 112

reducing the numbers of Clostridium perfringens that may grow in meat, poultry, or 

gravy if these products were improperly cooled. Vegetative cells of C. perfringens can 

cause foodborne illness when they grow to high numbers. Highly resistant 

C. perfringens spores will survive cooking and hot holding. If food is abused by being 

held at improper holding temperatures or improperly cooled, spores can germinate to 

become rapidly multiplying vegetative cells.

Although proper reheating will kill most organisms of concern, some toxins such as that 

produced by Staphylococcus aureus, cannot be inactivated through reheating of the 

food. It is imperative that food contamination be minimized to avoid this risk.

The potential for growth of pathogenic bacteria is greater in reheated cooked foods than 

in raw foods. This is because spoilage bacteria, which inhibit the growth of pathogens 

by competition on raw product, are killed during cooking. Subsequent recontamination 

will allow pathogens to grow without competition if temperature abuse occurs. 

Shelf-stable, commercially prepared ready-to eat foods in hermetically sealed 

containers will have received a controlled retort process that destroys all bacterial 

pathogens, both vegetative cells and spores, to provide a commercially sterile product. 

Refrigerated, commercially processed, ready-to-eat, TCS food will have received 

controlled thermal processing that destroys vegetative bacterial cells and a controlled 

cooling process that prevents the germination of any spores present. Packaging 

prevents recontamination and refrigeration prevents spore germination. Because there 

is limited risk of contamination in these types of products, reheating such foods to the 

minimum hot holding temperature of 135°F is considered adequate when reheating for 

hot holding. This should be the case for product that remains in the container or 

package after it is opened, provided the proper steps are taken to protect the remaining 

portions from contamination and they are maintained at the appropriate cold holding 

temperatures as specified in the Food Code. 

Refer also to the public health reason for § 3-401.12. 

3-404.11 Treating Juice. 

Refer to the public health reason for § 3-801.11. 

Temperature and time control

3-501.11 Frozen Food.

3-501.12 Time/Temperature Control for Safety Food, Slacking.

3-501.13 Thawing.

Freezing prevents microbial growth in foods, but usually does not destroy all 

microorganisms. Improper thawing provides an opportunity for surviving bacteria to 

grow to harmful numbers and/or produce toxins. If the food is then refrozen, significant 

numbers of bacteria and/or all preformed toxins are preserved.
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ROP Fish

Retailers should be aware that when a manufacturer packages fish and fishery products 

a hazard analysis is required under 21 CFR Parts 123 and 1240, Procedures for the 

Safe and Sanitary Processing and Importing of Fish and Fishery Products (the Seafood 

HACCP Rule) to provide for control for nonproteolytic C. botulinum. Factors that make 

formation of C. botulinum toxin reasonably likely to occur during finished product 

storage and distribution are those that may result from the use of a reduced oxygen 

packaging (ROP) environment in a food that does not contain barriers to growth of C. 

botulinum. 

The processing control for C. botulinum can be either freezing, refrigeration alone or 

refrigeration in combination with chemical inhibitors, (e.g. salt, water activity control). 

The Fish and Fishery Products Hazards and Control Guidance, Fourth Edition, Chapter 

13, addresses freezing as a control strategy for frozen product. This control is intended 

to prevent exposure of the product to conditions conducive to the production of toxin by 

nonproteolytic strains of C. botulinum in the closed ROP package.

If freezing was chosen by the manufacturer as the barrier to control for nonproteolytic 

strains of C. botulinum, then each individual package of the ROP fish should be labeled 

to be kept frozen and thawed according to the manufacturer’s label instructions. 

Typically ROP fish will come into retail food establishments in a frozen state with a label 

that indicates to “thaw immediately before use” or indicates that the product needs to be 

“kept frozen, and thawed under refrigeration immediately before use.” 

If a “Keep Frozen” label is not present on each individual ROP package unit, it may or 

may not be acceptable to store under refrigeration, depending in part on whether there 

are barriers such as pH or water activity to growth of C botulinum in addition to 

refrigeration. 

As an added safeguard to prevent the possibility of C. botulinum toxin formation, the 

Food Code requires that any frozen ROP fish that does not have barriers to growth of C. 

botulinum in addition to refrigeration be completely removed from the ROP environment 

or package prior to thawing. This is to discourage the practice of thawing frozen ROP 

fish and holding it at 41oF or less for a prolonged time period and/or selling it as a 

refrigerated product. 

3-501.14 Cooling.

Safe cooling requires removing heat from food quickly enough to prevent microbial 

growth. Excessive time for cooling of time/temperature control for safety foods has been 

consistently identified as one of the leading contributing factors to foodborne illness. 

During slow cooling, time/temperature control for safety foods are subject to the growth 

of a variety of pathogenic microorganisms. A longer time near ideal bacterial incubation 

temperatures, 21oC - 52oC (70oF - 125oF), is to be avoided. If the food is not cooled in 

accordance with this Code requirement, pathogens may grow to sufficient numbers to 

cause foodborne illness. 
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The Food Code provision for cooling provides for cooling from 135oF to 41°F or 45°F in 

6 hours, with cooling from 135oF to 70°F in 2 hours. The 6-hour cooling parameter, with 

an initial 2-hour rapid cool, allows for greater flexibility in meeting the Code. The initial 2-

hour cool is a critical element of this cooling process. An example of proper cooling 

might involve cooling from 135oF to 70oF in 1 hour, in which case 5 hours remain for 

cooling from 70oF to 41oF or 45oF. Conversely, if cooling from 135oF to 41°F or 45°F is 

achieved in 6 hours, but the initial cooling to 70oF took 3 hours, the food safety hazards 

may not be adequately controlled. 

If the cooking step prior to cooling is adequate and no recontamination occurs, all but 

the spore-forming organisms such as Clostridium perfringens or Bacillus cereus

should be killed or inactivated. However, under substandard sanitary conditions, other 

pathogens such as Salmonella or Listeria monocytogenes may be reintroduced. 

Thus, cooling requirements are based on growth characteristics of organisms that may 

survive or be a post-cook contaminate and grow rapidly under temperature abuse 

conditions. 

Shell Eggs

FDA has approved the use of ionizing radiation for shell eggs. This approval means that 

FDA has not found the ionizing radiation process to be unsafe for shell eggs. However, 

shell eggs that have been subjected to the approved ionizing radiation process are not 

considered to have been pasteurized. Shell egg pasteurization requires the egg to have 

been subjected to a 5-log kill process for Salmonella Enteritidis, while the approved 

ionizing radiation process may deliver only 2 or 3 logs reduction. Therefore, eggs 

treated by ionizing radiation process alone must be held under refrigeration, as it cannot 

be guaranteed that Salmonella Enteritidis will be eliminated in all treated eggs. 

Further, irradiated eggs must be labeled in accordance with 21 CFR 179.26 Ionizing 

radiation for the treatment of food. 

Hard-boiled eggs with shell intact may be cooled in ambient air and are not considered 

to be a time/temperature control for safety food after cooling. Hard-boiled eggs may be 

cooled in drinking water but are considered to be a time/temperature control for safety 

food after cooling because pathogens, which may be present in the water, may pass 

through the egg shell during cooling. 

Salmonella Enteritidis has been shown to have an extended lag phase in shell eggs 

due to inhibitory characteristics of the albumen. Research indicates that the organisms 

are physically located near the exterior of the yolk membrane, in contact with the 

bacteriostatic components. Growth does not appear until the yolk membrane is 

weakened by age or physically breached and the yolk nutrients, such as iron, become 

available to the organisms. 

Federal regulations effective August 27, 1999, require shell eggs to be transported and 

distributed under refrigeration at an ambient temperature not to exceed 45°F. Packed 

shell eggs must be labeled indicating that refrigeration is required. Imported shell eggs 

packed for consumer use are required to include a certification that the eggs, at all 
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 115

times after packing, have been stored and transported at an ambient temperature of no 

greater than 45°F. 

On December 5, 2000 federal regulations were amended to require that shell egg 

cartons bear safe handling instructions and be placed under refrigeration at 45°F or 

lower upon delivery at retail establishments (65 FR 76091, December 5, 2000, Food 

Labeling, Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of Shell Eggs 

Held for Retail Distribution). The amended provisions include: 

• 21 CFR Part 16 Regulatory Hearing before the Food and Drug Administration, 

§ 16.5 Inappplicability and limited applicability, (4) A hearing on an order for relabeling, diversion or destruction of shell eggs...

• 21 CFR Part 101 Food Labeling § 101.17 Food labeling warning, notice, and safe 

handling statements, (h) Shell eggs. 

• 21 CFR Part 115 Shell Eggs, § 115.50 Refrigeration of shell eggs held for retail 

distribution. 

Shell eggs must be placed immediately after receipt in refrigerated equipment that is 

capable of maintaining an ambient air temperature of 45°F. With the newly established 

Federal requirement for eggs to be in an ambient storage and transportation 

temperature of 45°F, and with refrigeration of eggs at retail as described above, the 

overall time that eggs are stored at temperatures that allow the growth of Salmonella

spp. should be shortened. Additionally, this requirement negates the need to "cool" shell 

eggs upon receipt, although food establishment operators should maximize the 

circulation of cooled air in refrigeration units by separating flats, cases, and multiple 

cartons of eggs. 

CFSAN/FSIS Joint Position Paper on Cooling

The processing of most ready-to-eat products includes a heat treatment or cooking step

to eliminate pathogenic and spoilage microorganisms. However, this heat treatment 

does not eliminate spores of Clostridium botulinum and Clostridium perfringens and 

other spore-forming bacteria. Furthermore, these organisms can thrive in the warm 

product since other competing organisms have been eliminated. Non-refrigerated, 

anaerobic conditions are conducive to their growth and multiplication. 

To prevent the growth and multiplication of spore-forming organisms, product should be 

cooled rapidly after cooking. When there is inadequate cooling, spores can germinate 

and the resulting vegetative cells can multiply to hazardous levels. The presence of 

sufficient numbers of C. botulinum or other spore-forming organisms may lead to 

production of harmful toxins. Therefore, ensuring no growth of these organisms will 

provide the greatest amount of safety. 

The USDA/FSIS Performance Standards for the Production of Certain Meat and Poultry 

Products require a stabilization step (cooling) after the lethality step. The stabilization 

requirements allow for no growth of C. botulinum and no more than 1 log growth of

C. perfringens. The performance standard of no more than 1 log growth of 
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Annex 3 - 116

C. perfringens was based originally on a 1998 Lethality and Stabilization Performance 

Standards for Certain Meat and Poultry Products: Technical Paper.

At the time, the 1998 FSIS Technical Paper was made available, FSIS determined 1-log 

growth of C. perfringens would provide an acceptable level of protection when 

considering worst-case levels of 4-logs CFU/g and building in a 1-log safety margin to 

ensure under worst-case levels would be below that which can cause human illness 

(i.e., 6-logs CFU/gram or higher). FSIS has reviewed newer data such as that from a 

large pork processing establishment in the Midwest showing that the C. perfringens

spore counts were close to 3-logs CFU/g. Therefore, the Agency now considers 3-logs 

CFU/g C. perfringens in product a worst-case estimate. In 2010, the National Advisory 

Committee on Microbiological Criteria for Foods (NACMCF) recommended building in a 

2-log margin of safety to performance standards as opposed to the 1-log used in the 

Technical Paper. Therefore, FSIS still considers allowing up to 1-log of C. perfringens in 

product to be an acceptable level of protection when considering worst-case spore 

counts of 3-log and a 2-log safety margin.

The FSIS Stabilization Guideline for Meat and Poultry Products (Revised Appendix B), 

which can be found at https://www.fsis.usda.gov/guidelines/2021-0013 has cooling 

options for both ready-to-eat (RTE) and not ready-to-eat (NRTE) products that are 

cooked to lethality in Table 1. Cooling options for partially NRTE cooked products are 

included in Table 2. The guideline results in continuous and rapid cooling of the product 

in the temperature range where the spore-forming organisms can grow rapidly.

The former USDA guideline of cooling from 120oF to 55°F in no more than 6 hours is 

also included in the new guidelines. In using this guideline, chilling should begin within 

90 minutes after the cooking cycle is completed, and cooling should continue until 

product reaches 40°F. The 6-hour rule begins when the product reaches 120oF, and 

product should not be shipped until the product reaches 40°F. In addition, 

establishments should ensure product also cools between 120oF and 80°F in 1 hour or 

less unless the product is large mass (> 4.5 inches thick or > 8 pounds) and non-intact 

(such as injected turkey breast or injected roast beef). For these products, FSIS has 

determined that due to their size and challenges with cooling in a timely manner that 

this option can be followed without demonstrating the amount of time product remains 

between 120oF and 80°. Such guidance can be followed until further research can be 

conducted to support cooling of these products.

The FSIS cooling guideline for meat and poultry products containing 100 ppm 

added nitrite is 130oF to 80°F in 5 hours and from 80oF to 45°F in 10 hours, a total of 

15 hours cooling time. This cooling process provides a narrow margin of safety. In case 

of cooling deviations, the establishment should assume that their process has exceeded 

the performance standard for controlling the growth of C. perfringens, and should take 

corrective action. However, the presence of nitrite should ensure compliance with the 

performance standard for C. botulinum.

The Food Code provision for cooling is similar, though not identical to the FSIS cooling 

compliance guidelines. It provides for cooling from 135oF to 70°F in 2 hours and from 
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 117

135oF to 41°F or 45°F in 6 hours and is based on the same food safety concerns as 

FSIS’ guidance. The Food Code provides prescriptive cooling time/temperature 

combinations without a HACCP plan in place. Federally inspected meat and poultry 

establishments are required to implement a HACCP plan for their operations. 

The Conference for Food Protection (CFP) at its 2000 meeting recommended that FSIS 

and FDA ask the National Advisory Committee on Microbiological Criteria for Foods 

(NACMCF) to review the data on safe cooling times for cooked, time/temperature 

control for safety foods. The review would include data from a study, submitted to the 

CFP, showing that cooling of a meat product from 130oF to 45°F can safely take place 

in 15 hours based on a study by V.K. Juneja, et al., 1994. According to the authors of 

the study, continuous cooling of a meat product from 130oF to 45°F in 15 hours 

permitted about 1 log growth of C. perfringens. 

In response to the CFP recommendation, the FSIS Administrator and CFSAN agreed 

that the data referenced in the CFP recommendation do not support a change in the 

FSIS guidance or the Food Code § 3-501.14 and considered it inadvisable to ask the 

NACMCF to undertake the task requested for several reasons: 

1. The study did not address growth of C. botulinum.

2. The results are from a carefully controlled laboratory study in which cooling of 

the product was steady and continuous, conditions difficult to maintain in most 

commercial processing or retail environments even with data loggers and 

other control mechanisms in place. 

3. The study was done only on ground beef and may not be applicable to other 

meat and poultry or to other time/temperature control for safety foods. 

As an alternative response, CFSAN and FSIS advised CFP that they would provide this 

written position paper to clarify their joint position on the cooling issues. 

3-501.15 Cooling Methods.

Large food items, such as roasts, turkeys, and large containers of rice or refried beans, 

take longer to cool because of the mass and volume from which heat must be removed. 

By reducing the volume of the food in an individual container, the rate of cooling is 

dramatically increased and opportunity for pathogen growth is minimized. If the hot food 

container is tightly covered, the rate of heat transfer is reduced, i.e., the time required 

for cooling and the time the food is exposed to optimal temperatures for bacterial 

multiplication or toxin production are increased.

Alternatives to conventional methods include avoiding the need to cool larger masses 

by preparing smaller batches closer to periods of service or chilling while stirring hot 

food in containers within an ice water bath. Commercial refrigeration equipment is 

designed to hold cold food temperatures, not cool large masses of food. Rapid chilling 

equipment is designed to cool the food to acceptable temperatures quickly by using 

very low temperatures and high rates of air circulation.
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Annex 3 - 118

3-501.16 Time/Temperature Control for Safety Food, Hot and Cold 

Holding.

Bacterial growth and/or toxin production can occur if time/temperature control for safety 

food remains in the temperature "Danger Zone" of 5oC to 57oC (41oF to 135oF) too long. 

Up to a point, the rate of growth increases with an increase in temperature within this 

zone. Beyond the upper limit of the optimal temperature range for a particular organism, 

the rate of growth decreases. Operations requiring heating or cooling of food should be 

performed as rapidly as possible to avoid the possibility of bacterial growth. 

Cold Holding

Maintaining TCS foods under the cold temperature control requirements prescribed in 

this code will limit the growth of pathogens that may be present in or on the food and 

may help prevent foodborne illness. All microorganisms have a defined temperature 

range in which they grow, with a minimum, maximum, and optimum. An understanding 

of the interplay between time, temperature, and other intrinsic and extrinsic factors is 

crucial to selecting the proper storage conditions for a food product. Temperature has 

dramatic impact on both the generation time of an organism and its lag period.

When considering growth rate of microbial pathogens, time and temperature are integral 

and must be considered together. Increases in storage and/or display temperature will 

decrease the shelf life of refrigerated foods since the higher the temperature, the more 

permissive conditions are for growth.

The exception for holding time/temperature control for safety food in specially designed 

dispensing equipment recognizes technology designs that maintain the safety of 

aseptically-packaged fluid foods when the equipment is manufactured and operated in 

conformance with the NSF/ANSI Standard No. 18. NSF/ANSI 18 was revised in 2006, 

with FDA input, to address the storage of certain types of time/temperature for safety 

food or beverages in dispensing equipment without temperature control. The key 

condition for FDA allowing this exemption from 3-501.16 is that the equipment conforms 

to the requirements as specified in NSF/ANSI 18. 

Except for raw shell eggs, control of the growth of Listeria monocytogenes (Lm) is the 

basis for the list of cold holding temperature and time combinations in paragraph 

3-501.17(A). The list addresses time, in addition to temperature, as a control for the 

growth of Lm in refrigerated, ready-to-eat, time/temperature control for safety food. The 

Code provisions for cold holding focus on environmental conditions that allow 1 log of 

growth of Lm, and do not set an acceptable number of Lm in food. Neither do they imply 

that Lm is in the product. 

The times and temperatures in the 1999 Food Code were based on the USDA 

Pathogen Modeling Program (PMP), which is conservative in estimating how soon Lm

begins to grow and how fast. The PMP was based largely on observations of microbial 

growth in broth cultures, but some observations in specific foods were also included. 

The PMP allows for some variation in temperature, pH, and water activity, and gives a 

conservative estimate of safe times and temperatures for holding foods. The 1999 Food 
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Annex 3 - 119

Code estimated safe times and temperatures that would allow 3 logs of growth, based 

on the PMP. 

During 2000, CFSAN researched published literature and compiled a listing of the 

growth potential of Lm in various food commodities using real food data. Based on this 

information, the 1999 Food Code times and temperatures of 41oF for 7 days and 45oF 

for 4 days were validated, but the underlying performance standard changed for the 

commodities studied. The research-based, food-specific times and temperatures allow 

no more than 1 log of growth instead of the 3 log growth predicted in the PMP. This 

more stringent performance standard of 1 log is consistent with the USDA/FSIS 

performance standard and the fact that the infectious dose of Lm remains unknown. 

FDA concluded that the 1999 Code time/temperature criteria hold true and provide both 

a greater level of safety and a more realistic basis for regulatory requirements without 

compromising public health protection. 

In October 2003, FDA, in cooperation with the USDA/FSIS and CDC, released the 

Quantitative Assessment of the Relative Risk to Public Health from Foodborne Listeria 

monocytogenes Among Selected Categories of Ready-to-Eat Foods (risk assessment)

at

http://www.fda.gov/downloads/Food/ScienceResearch/ResearchAreas/RiskAssessment

SafetyAssessment/UCM197329.pdf. 

This initiative included the development of 23 separate risk assessments and analysis 

of the relative risks of serious illness and death associated with consumption of 23 

categories of ready-to-eat foods. These categories included: seafood, produce, meats, 

dairy products, and deli salads. 

The risk assessment identified several broad factors that affect consumer exposure to 

Lm at the time of food consumption. Two of these factors, refrigerated storage 

temperature and duration of refrigerated storage before consumption, have a direct 

bearing on cold holding time/temperature combinations used in food establishments. 

FDA continues to have concerns about the potential for growth of Lm in refrigerated, 

ready-to-eat, time/temperature control for safety food, prepared and packaged in a food 

processing plant and held in a food establishment. Data from the risk assessment (see 

the following Annex 3, 3-501.16, Table 1) show a significant reduction in the projected 

cases of listeriosis when refrigerated storage is limited to 41oF. Based on these data 

and conclusions from the risk assessment, FDA continues to recommend that food 

establishments limit the cold storage of time/temperature control for safety foods, readyto-eat foods to a maximum temperature of 41oF. 
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Annex 3 - 120

3-501.16 Table 1. Estimated Reduction of Cases of Listeriosis from 

Limits on Refrigeration Temperatures *

MAXIMUM

REFRIGERATOR

TEMPERATURE

CASES OF 

LISTERIOSI a

MEDIAN

CASES OF 

LISTERIOSIS a

5th Percentile

CASES OF 

LISTERIOSIS a

95th 

Percentile

Baseline b 2105 3⁄4 c 3⁄4 c

7  ̊C (45  ̊F) maximum 656 331 761

5  ̊C (41  ̊F) maximum 28 1 126

a Values for the median, upper and lower uncertainty levels.

b The baseline uses the full empirical distribution of refrigerator temperatures from the Audits 

International (1999) survey.

c The baseline number of cases of listeriosis is fixed based on CDC surveillance data.

* The scenario assumed the distribution of storage times is the same for all three temperature 

sets. 

Source: Quantitative Assessment of the Relative Risk to Public Health from Foodborne 

Listeria monocytogenes Among Selected Categories of Ready-to-Eat Foods September 

2003. Table VI-1. Estimated Reduction of Cases of Listeriosis from Limits on Refrigeration 

Temperatures. 

Regarding shell eggs, USDA published a final rule (63 FR 45663, August 27, 1998 

Refrigeration and Labeling Requirements for Shell Eggs) to require that shell eggs 

packed for consumer use be stored and transported at an ambient temperature not to 

exceed 7oC (45oF). This regulation, however, does not apply to eggs while held at all 

retail establishments. 

FDA is concerned that without continued refrigeration up until the time that the eggs are 

cooked, there would be an opportunity for the egg's defenses to degrade and growth of 

Salmonella Enteritidis to occur. The agency reviewed research indicating that 

Salmonella Enteritidis multiplies at temperatures of 10oC (50oF) and above but can be 

inhibited at lower temperatures, e.g., 8oC (46oF), 7oC (45oF), and 4oC (39oF). Based on 

this research and USDA's temperature requirement during transport, FDA implemented 

regulations that establish a maximum ambient air temperature of 7oC (45oF) for eggs 

stored and displayed at retail establishments. Amended Federal regulations 21 CFR 

Part 115.50 issued on December 5, 2000 and became effective on June 4, 2001. 

Although Congress did not expressly preempt State law in this area, FDA found 

preemption is needed because State and local laws that are less stringent than the 

Federal requirements will not support the important public health goals of these 

regulations. FDA does not believe that preemption of State and local refrigeration and 
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 121

labeling requirements that are the same as or more stringent than the requirements of 

these regulations is necessary, as enforcement of such State and local requirements 

will support the food safety goals of these regulations. Accordingly, the preemptive 

effect of this rule is limited to State or local requirements that are not as stringent as the 

requirements of these regulations; requirements that are the same as or more stringent 

than FDA's requirements remain in effect. 

Historical Record of Cold Holding Temperature Provisions

The 1976 Food Service Sanitation Manual recommended 45°F as the cold holding 

temperature. Based on the available science at the time, the 1993 Food Code lowered 

the cold holding temperature to 41°F.

However, stakeholders raised concerns that many of the refrigerators currently in place 

in food establishments would not be capable of maintaining food at that temperature. 

There was also concern that most of the open-top buffet and food prep table-type units 

being built at the time could not reliably maintain food at 41°F or less. Industry pointed 

out that operators needed to recover investments in new refrigeration equipment 

purchased just before or after a state adopted the 41°F provision.

Consequently, the Conference of Food Protection (CFP) recommended the 1997 Food 

Code incorporate the option of having a 5-year phase-in period for the 41°F requirement 

to allow for upgrading of existing equipment, and the FDA agreed. 

By 2006, many states adopted and implemented the phase-in period, the 5 years had 

expired and they were requiring cold holding at 41°F or less. In addition, NSF/ANSI 

Standard 7 was revised in 1997 and again in 1999 to ensure that equipment conforming 

to the Standard, including open-top and display units, could achieve the desired 

performance under conditions typically found in the food service and retail 

environments. Thus, there are mechanisms in place to allow industry flexibility in 

holding foods out of temperature control and the exemption for holding at 45°F was no 

longer necessary, given equipment capabilities, existing provisions of the Food Code 

that could be utilized (e.g., variances, time as a public health control), and the impact on 

public health. Additionally, the FDA believed this exemption was no longer necessary 

and perhaps was detrimental to public health protection in light of what had been 

learned about the growth and survival of Listeria monocytogenes (LM) in refrigerated 

foods. 

In 2006, the CFP recommended (CFP Issue 2006-I-033) and FDA agreed that the 

option of maintaining 45°F as a cold holding temperature be deleted from § 3-501.16. In 

the Supplement to the 2005 Food Code, the option to maintain 45°F as the cold holding 

temperature was deleted from the Food Code and 41°F became the standard for cold 

holding. 
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Hot Holding

In a January 2001 report, the National Advisory Committee on Microbiological Criteria 

for Foods (NACMCF) recommended that the minimum hot holding temperature 

specified in the Food Code: 

• Be greater than the upper limit of the range of temperatures at which 

Clostridium perfringens and Bacillus cereus may grow; and 

• Provide a margin of safety that accounts for variations in food matrices, 

variations in temperature throughout a food product, and the capability of hot 

holding equipment to consistently maintain product at a desired target 

temperature. 

C. perfringens has been reported to grow at temperatures up to 52°C (126°F). Growth 

at this upper limit requires anaerobic conditions and follows a lag phase of at least 

several hours. The literature shows that lag phase duration and generation times are 

shorter at incubation temperatures below 49°C (120°F) than at 52°C (125°F). Studies 

also suggest that temperatures that preclude the growth of C. perfringens also 

preclude the growth of B. cereus.

CDC estimates that approximately 250,000 foodborne illness cases can be attributed to 

C. perfringens and B. cereus each year in the United States. These spore-forming 

pathogens have been implicated in foodborne illness outbreaks associated with foods 

held at improper temperatures. This suggests that preventing the growth of these 

organisms in food by maintaining adequate hot holding temperatures is an important 

public health intervention.

Taking into consideration the recommendations of NACMCF and the 2002 Conference 

for Food Protection meeting, FDA believes that maintaining food at a temperature of 

57°C (135°F) or greater during hot holding is sufficient to prevent the growth of 

pathogens and is therefore an effective measure in the prevention of foodborne illness. 

3-501.17 Ready-to-Eat, Time/Temperature Control for Safety Food, Date 

Marking. 

3-501.18 Ready-to-Eat, Time/Temperature Control for Safety Food, 

Disposition. 

Refer to Annex 7, Chart 4-C. 

Refrigeration prevents food from becoming a hazard by significantly slowing the growth 

of most microbes. The growth of some bacteria, such as Listeria monocytogenes, is 

significantly slowed but not stopped by refrigeration. Over a period of time, this and 

similar organisms may increase their risk to public health in ready-to-eat foods. 

Based on a predictive growth curve modeling program for Listeria monocytogenes, 

ready-to-eat, time/temperature control for safety food may be kept at 5oC (41oF) a total 

of 7 days. Food which is prepared and held, or prepared, frozen, and thawed must be 

controlled by date marking to ensure its safety based on the total amount of time it was 
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 123

held at refrigeration temperature, and the opportunity for Listeria monocytogenes to 

multiply, before freezing and after thawing. Time/temperature control for safety 

refrigerated foods must be consumed, sold or discarded by the expiration date. 

Date marking is the mechanism by which the Food Code requires active managerial 

control of the temperature and time combinations for cold holding. Industry must 

implement a system of identifying the date or day by which the food must be consumed, 

sold, or discarded. Date marking requirements apply to containers of processed food 

that have been opened and to food prepared by a food establishment, in both cases if 

held for more than 24 hours, and while the food is under the control of the food 

establishment. This provision applies to both bulk and display containers. It is not the 

intent of the Food Code to require date marking on the labels of consumer size 

packages.

A date marking system may be used which places information on the food, such as on 

an overwrap or on the food container, which identifies the first day of preparation, or 

alternatively, may identify the last day that the food may be sold or consumed on the 

premises. A date marking system may use calendar dates, days of the week, colorcoded marks, or other effective means, provided the system is disclosed to the 

Regulatory Authority upon request, during inspections.

As part of the effort to enhance understanding by industry and regulators regarding the 

proper labeling and disposition of time/temperature control for safety (TCS) food 

prepared in a retail food establishment and held longer than 24 hours, the FDA 

developed a fact sheet to visually display examples of some date marking systems. This 

fact sheet is intended for retail food establishments and regulatory authorities to better 

understand the types of information that may be included on a date marking label and 

what the disposition time of that product looks like based on the information provided. 

This document is available at: https://www.fda.gov/media/127796/download

FDA/USDA/CDC Listeria monocytogenes Risk Assessment

In September, 2003, FDA, in cooperation with USDA/FSIS and CDC, released the 

Quantitative Assessment of the Relative Risk to Public Health from Foodborne Listeria 

monocytogenes Among Selected Categories of Ready-to-Eat Foods at 

http://www.fda.gov/downloads/Food/ScienceResearch/ResearchAreas/RiskAssessment

SafetyAssessment/UCM197329.pdf. This initiative included the development of 23 

separate risk assessments and analysis of the relative risks of serious illness and death 

associated with consumption of 23 categories of ready-to-eat foods. These categories 

included: seafood, produce, meats, dairy products, and deli salads. 

In examining these closely, FDA showed that 5 factors are important in measuring the 

public health impact to consumers from foodborne listeriosis. These factors are: 

(1) amounts and frequency of consumption of a ready-to-eat food; (2) frequency and 

levels of L. monocytogenes in a ready-to-eat food; (3) potential of the food to support 

growth of the bacterium during refrigeration; (4) refrigerated storage temperature; and 

(5) duration of refrigerated storage before consumption. 
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Annex 3 - 124

Based on these 5 factors, the 23 categories of ready-to-eat foods were ranked 

according to their relative risk of contamination and growth of Listeria 

monocytogenes. The risk categories used were: very high risk; high risk; moderate 

risk; low risk; and very low risk. 

Impact of the Listeria monocytogenes Risk Assessment on Date 

Marking

Based on the results of the risk assessment and the recommendations 

from the 2004 Conference for Food Protection meeting, it was necessary 

to re-evaluate date marking in an effort to focus the provision on very high 

and high risk foods, while at the same time, exempting foods that present 

a very low, or low risk of contamination and growth of Listeria 

monocytogenes. Based on this evaluation, date marking provisions of 

the Food Code do not apply to the following foods: 

Deli Salads Prepared and Packaged in a Food Processing Plant

Examples of deli salads include ham salad, chicken salad, egg salad, 

seafood salad, pasta salad, potato salad, and macaroni salad, 

manufactured according to 21 CFR 117. According to data from the risk 

assessment, deli salads prepared and packaged by a food processing 

plant contain sufficient acidity, along with the addition of preservatives 

(e.g., sorbate, benzoates), to prevent the growth of Listeria 

monocytogenes. There are estimates that 85% of all deli salads are 

prepared and packaged in a food processing plant and do not support 

growth. Based on discussions with deli salad manufacturers and trade 

associations, it is a nearly universal practice for food processing plants 

preparing and packaging deli salads to add one or more preservatives that 

inhibit the growth of Listeria monocytogenes. Based on their wide use 

within this segment of the industry and their effectiveness at inhibiting the

growth of Listeria monocytogenes, all deli salads prepared and 

packaged in a food processing plant are exempt from date marking. 

However, all deli salads prepared in a food establishment require date 

marking. 

Hard and Semi-Soft Cheeses

In December, 1999, FDA issued an exemption from date marking for 

certain types of hard and semi-soft cheeses (https://wayback.archiveit.org/7993/20170404235325/https://www.fda.gov/Food/GuidanceRegulati

on/RetailFoodProtection/IndustryandRegulatoryAssistanceandTrainingRes

ources/ucm113942.htm) based on the presence of several factors that 

may control the growth of Listeria monocytogenes. These factors may 

include organic acids, preservatives, competing microorganisms, pH, 

water activity, or salt concentration. The results of the risk assessment 

support this interpretation and therefore, hard and semi-soft cheeses each 

manufactured according to 21 CFR 133 are exempt from date marking.
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 125

LIST OF HARD CHEESES 

EXEMPT FROM DATE MARKING

LIST OF SEMI-SOFT CHEESES

EXEMPT FROM DATE MARKING

Asadero

Abertam

Appenzeller

Asiago medium or old 

Bra

Cheddar 

Christalinna

Colby 

Cotija Anejo

Cotija

Coon

Derby

Emmentaler 

English Dairy

Asiago soft 

Battelmatt

Bellelay (blue veined)

Blue 

Brick 

Camosum

Chantelle 

Edam

Fontina

Gorgonzola (blue veined) 

Gouda 

Havarti 

Gex (blue veined)

Gloucester

Gjetost

Gruyere 

Herve 

Lapland

Lorraine

Oaxaca

Parmesan 

Pecorino

Queso Anejo

Queso Chihuahua

Queso de Prensa

Romanello

Romano 

Konigskase 

Limburger 

Milano

Manchego

Monterey 

Muenster

Oka

Port du Salut 

Provolone

Queso de Bola

Queso de la Tierra

Robbiole

Roquefort (blue veined) 

Samsoe 

Tilsiter 
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 126

LIST OF HARD CHEESES 

EXEMPT FROM DATE MARKING

LIST OF SEMI-SOFT CHEESES

EXEMPT FROM DATE MARKING

Reggiano 

Sapsago 

Sassenage (blue veined)

Stilton (blue veined)

Swiss 

Tignard (blue veined)

Vize 

Wensleydale (blue veined)

Trappist

Cultured Dairy Products

Cultured dairy products include yogurt, sour cream, and buttermilk, each 

manufactured according to 21 CFR 131. Many of these products often are 

low pH foods manufactured with lactic acid fermentation. Data from the 

risk assessment show that Listeria monocytogenes does not grow in 

these foods and therefore, these products are exempt from date marking. 

Preserved Fish Products

Preserved fish products include pickled herring and dried, or salted cod, 

and other acidified fish products, manufactured according to 21 CFR 114. 

Data from the risk assessment show that the high salt and/or acidity of 

these products does not allow for the growth of Listeria monocytogenes

and therefore, these products are exempt from date marking. This 

exemption does not apply to hot or cold smoked fish products, nor does it 

apply to fish products that are dried, marinated, or otherwise preserved 

on-site, in a food establishment, such as ceviche.

Shellstock 

Although Listeria monocytogenes has been isolated from shellstock there have been

no reported Listeriosis cases linked to the consumption of this product at retail. The 

competitive microflora present in and on shellstock inhibits the growth of Listeria 

monocytogenes to harmful levels when the product is held under refrigeration at retail. 

Therefore shelllstock are exempt from date marking. 

USDA-regulated Products

Date marking provisions of the Food Code do not apply to shelf stable ready-to-eat meat 

and poultry products. Shelf stable ready-to-eat meat and poultry products are not required 

by USDA to be labeled “Keep Refrigerated.” For these products, the nitrite and salt in the 

cure and the lower pH resulting from fermentation give additional protection against 
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 127

microbial growth. Some fermented sausages and salt-cured products are shelf stable, do 

not require refrigeration, and do not bear the label “Keep Refrigerated.” To be shelf stable, 

a product manufactured under USDA inspection must have a process that results in a 

product that meets one of the recognized objective criteria for shelf stability, such as water 

activity, moisture-protein ratio (MPR), or combination of MPR and pH (acidity). Therefore 

they are exempt from the Food Code date marking requirements. 

Shelf stable fermented sausages such as pepperoni and dry salami do not have to be 

refrigerated or date marked. Shelf stable salt-cured products such as prosciutto, country cured 

ham, or Parma ham do not require refrigeration or Food Code date marking. Other salt-cured 

products include basturma, breasaola, coppa, and capocolla. 

Some ready-to-eat fermented sausages and salt-cured products must be refrigerated 

and therefore bear the USDA-required label “Keep Refrigerated.” Examples of these 

products are cooked bologna, cooked salami, and sliced country ham which are readyto-eat fermented products that need refrigeration. Bologna is a cooked, perishable 

sausage and there are other salamis, e.g., cotto that are perishable. 

The intact casing on shelf-stable sausages may be overwrapped to protect the cut face 

of the sausage. With shelf stable (non-time/temperature control for safety food) 

sausages, the intact casing provides a barrier to contamination (although not an 

absolute one), the exposed face is likely to be sliced again within 4 or 7 days, and 

contamination is minimized because only the face is exposed. The coagulated protein 

that occurs on the surface of some nonshelf stable cooked sausages is not a casing. 

Slices of cured and fermented sausages that require refrigeration and are kept for 

24 hours or longer do need to be date marked. 

If open dating information is applied to lunchmeats at a federally inspected meat or 

poultry establishment, the information must comply with the requirements in 9 CFR 

317.8 and 381.129. However, such dating is not required by USDA/FSIS and if applied, 

would not supercede or replace date marking requirements established by the Food 

Code or by State/local authorities that apply after the food is opened in a retail 

establishment. 

Manufacturer’s use-by dates

It is not the intent of this provision to give a product an extended shelf life beyond that 

intended by the manufacturer. Manufacturers assign a date to products for various 

reasons, and spoilage may or may not occur before pathogen growth renders the 

product unsafe. Most, but not all, sell-by or use-by dates are voluntarily placed on food 

packages.

Although most use-by and sell-by dates are not enforceable by regulators, the 

manufacturer's use-by date is its recommendation for using the product while its quality 

is at its best. Although it is a guide for quality, it could be based on food safety reasons. 

It is recommended that food establishments consider the manufacturer’s information as 

good guidance to follow to maintain the quality (taste, smell, and appearance) and 
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 128

salability of the product. If the product becomes inferior quality-wise due to time in 

storage, it is possible that safety concerns are not far behind.

It is not the intention of this provision that either the manufacturer’s date or the date 

marked by the food establishment be placed on consumer packages.

3-501.19 Using Time as a Public Health Control. 

The 2000 Conference for Food Protection (CFP) meeting recommended that FDA ask 

the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) to 

review the Food Code provision that addresses using time alone as a public health 

control, section 3-501.19. In response to the CFP recommendation, FDA in consultatio 

n with USDA/FSIS, determined that there is sufficient scientific information available to 

support the current provision in the Food Code without requesting consideration by the 

NACMCF. As an alternative response, FDA informed the CFP that it would provide the 

following position paper on using time alone as a public health control. 

---------------Beginning of Position Paper----------------

Food Code section 3-501.19 allows time/temperature control for safety food that is 

ready-to-eat (RTE) to be stored without temperature control for up to 4 hours, after 

which it must be discarded or consumed or for up to 6 hours for refrigerated food, if the 

food is 5°C (41°F) when initially removed from temperature control, and as long as the 

food temperature does not exceed 21°C (70°F). The following information is provided to 

explain the reasoning in allowing time alone to be used as a public health control for 

food safety. 

Background Information

Food kept without temperature control allows product to warm or cool as it equilibrates 

with the environment. Each temperature scenario incurs different risks in regard to the 

type of foodborne pathogens able to grow and the rate of growth likely to occur. For 

both cooling and warming conditions, growth depends on the amount of time the food 

spends in an optimum growth temperature range during its equilibration with its 

surroundings. Several factors influence the rate of temperature change in a food, such 

as the type of food, thickness of the food, and temperature differential between the food 

and its surroundings. When evaluating the safety of a 4-hour limit for food with no 

temperature control, products and environmental parameters must be selected to create 

a worst-case scenario for pathogens growth and possible toxin production. 

Holding Cold Food Without Temperature Control

When a food is removed from refrigerated storage and begins to warm to room 

temperature, Listeria monocytogenes is a primary organism of concern. Even while 

food is held at refrigeration temperatures, the growth potential of L. monocytogenes

warrants concern for time/temperature control for safety foods RTE foods. Although the 

FDA and USDA have a zero tolerance for L. monocytogenes in RTE food, conditions 

are permitted in the Food Code that would allow L. monocytogenes cells 1 log of 
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 129

growth (3.3 generations). Salmonella is also a concern especially with products 

containing eggs. However L. monocytogenes grows more rapidly than Salmonella at 

refrigeration and room temperatures. By ensuring minimal Listeria growth in food, the 

threat from Salmonella would be negligible. Warming conditions will allow food to 

remain exposed to temperatures that allow B. cereus to produce emetic toxin. However 

the 4-hour time constraint in the Food Code is sufficient to prevent any toxin formation. 

For food refrigerated at 41oF or 45°F then transferred to an ambient temperature of 

75°F for 4 hours, the growth rate of L. monocytogenes remains slow enough to ensure 

that the critical limit of 1 log growth is not reached. Published generation times at 75°F 

for L. monocytogenes in food were not found, however published values at 68oF and 

70°F in egg and milk products confirmed slow L. monocytogenes growth at room 

temperatures. 

Using the USDA Pathogen Modeling Program (PMP) and assuming the optimum 

conditions of pH 6.8, 0.5% NaCl, 0.0% nitrite, L. monocytogenes would require more 

than 4 hours to grow 1 log at 75°F. The PMP is based on broth studies and not on food 

products. Therefore, the growth rates reported at various temperatures by the PMP are 

faster than growth rates in most food products. Another factor exaggerating the growth 

rate in this warming scenario as predicted by the PMP is the assumption that the food

product spent all 4 hours at 75°F. Obviously food equilibrates with the surrounding 

environment at a gradual rate and would not equilibrate instantly. 

Unfortunately there are no models that take changing temperatures into consideration 

when predicting growth. Likewise there are very few published papers dealing with the 

growth of organisms in food during warming. The conservative nature of the 4-hour limit 

for keeping foods without temperature control allows for a needed margin of safety if the 

temperature of the environment is higher than 75°F. 

It is important to note that time/temperature control for safety foods held without cold 

holding temperature control for a period of 4 hours do not have any temperature control 

or monitoring. These foods can reach any temperature when held at ambient air 

temperatures as long as they are discarded or consumed within the four hours. 

Holding Hot Food without Temperature Control

The second scenario for food without temperature control exists when food is cooked 

according to Food Code recommendations, then kept at room temperature for 4 hours 

before discarding. Foodborne pathogens of concern for an uncontrolled temperature 

scenario are sporeformers including Clostridium perfringens and Bacillus cereus. 

Food cooked according to Food Code guidelines should be free of vegetative cells. 

However, the heat requirements are not sufficient to kill spores of C. perfringens or 

B. cereus and may actually serve as a heat shock that activates the spores. B. cereus

is found commonly in outbreaks attributed to inadequate hot holding of starchy foods 

like rice, and has been isolated in a multitude of food products. C. perfringens is found 

commonly in outbreaks attributed to inadequate hot holding of beef and poultry. Despite 

the prevalence of both spores in nature, C. perfringens cases are estimated to be more 

numerous than B. cereus cases by a factor of 10. 
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

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B. cereus can produce emetic toxin in food, and the optimum temperature for the 

production of toxin is between 77°F and 86°F. However, the time needed to produce the 

toxin is longer than the time the food will be exposed to any temperature range with a 4-

hour holding limit. Both C. perfringens and B. cereus produce enterotoxin inside the 

intestine of the infected host if substantial numbers of vegetative cells are present in the 

food (105-7 CFU/g). Although the reported levels of both spores in raw foods vary in the

literature, generally the level expected in food can be assumed to be low (around 10-

1000 CFU/g). This implies that conditions allowing 1 log growth of either spore could be 

tolerated in food. 

During the time without temperature control, the temperature of the food could decrease 

slowly enough to expose spores of both organisms to optimal growth conditions for a 

significant length of time. Like warming, several variables exist that determine the rate 

of heat transfer. Because of the wide variety of foods prepared it would be impossible to 

generalize how fast a typical product loses temperature after cooking. As with warming, 

it is prudent to imagine a worst-case scenario where heat loss is slowed. A beef roast 

slow cooked to 130°F for the appropriate time according to the Food Code was used as 

consideration for possible spore growth. Cooking roast beef to 130°F can create an 

anaerobic environment in both the meat and gravy. The low internal temperature 

creates a small temperature differential with the environment (assumed at 75°F), 

allowing for a slower decrease in the food’s temperature. 

After evaluating published studies as well as data collected at the FDA, the surface of a 

roast beef or rolled meat product would lose heat quickly enough to discourage 

significant growth of either C. perfringens or B. cereus. If all spores were distributed 

on the surface of the product by either pre- or post-cooking contamination, storing this 

product for 4 hours at room conditions would be considered safe. Likewise, products 

that are stirred or products that lose heat faster than a roast would also be considered 

safe. 

----------- End of Position Paper ---------

At the 2004 meeting of the CFP, a committee submitted and the Conference accepted a 

document that examined scientific research related to the growth of Listeria 

monocytogenes, and the influence of time and temperature on its growth. 

The 2004 CFP report stated that the USDA-PMP program can be used as a tool to 

estimate time periods for a 1-log increase in growth for Listeria monocytogenes in 

ideal (laboratory media) growth conditions. Using this modeling approach, at 41°F, 

45°F, and 50°F, the time for a 1-log increase was, 87.8, 53.9, and 34.7 hours, 

respectively. At room temperature (70°F) a 1-log increase was noted at 5.2 hours and at 

ideal growth temperatures (95°F), the reported time for a 1-log increase was 3.0 hours. 

In general, the data from the USDA-PMP program provides very conservative growth 

data and, in most cases, growth would be expected to be less rapid in a food system. 

This table does provide comparative information relative to growth rates at different 

holding temperatures in the event that time was used as a factor in managing food 

safely. 
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 131

The report further recommended that food could safely be held for up to 6 hours without 

external temperature control as long as the food temperature did not exceed 70°F. 

Based on that report and data from the Quantitative Assessment of the Relative Risk to 

Public Health from Foodborne Listeria monocytogenes Among Selected Categories of 

Ready-to-Eat Foods September 2003, the Food Code allows time/temperature control 

for safety food to be stored up to 6 hours without external temperature control provided 

that the food temperature does not exceed 70°F and the food is discarded or consumed 

at the end of the 6 hours. 

At the 2018 meeting of the CFP it was recommended that Section 3-501.19 be 

amended to allow raw agricultural commodities (RACs) that are cut on-site (such as 

tomatoes, melons, or leafy greens) or shelf-stable hermetically sealed containers (such 

as canned tuna) opened on-site have an initial temperature of 21°C (70°F) or less when 

time without temperature control is used as a public health control for a maximum of 4 

hours. Peer-reviewed scientific literature and the above-mentioned pathogen modeling 

has shown Salmonella spp. and L. monocytogenes will not exceed a 1-log increase in 

growth when started and maintained at 21°C (70°F) or less for up to 4 hours.

The Safety of the Time as a Public Health Control Provision from Cooking 

Temperatures (135°F or above) to Ambient

FDA conducted in-house laboratory experiments to test the safety of the existing TPHC 

provisions of 4 hours without temperature control starting with an initial temperature of 

135°F or above. Clostridium perfringens was chosen to represent a worst case scenario 

pathogen for foods allowed to cool from cooking temperatures to ambient without 

temperature control, because its spores can survive normal cooking procedures, it can 

grow at relatively high temperatures (>120°F) and it has a short lag period. 

C. perfringens spores were inoculated into foods that were cooked and then cooled to 

yield a cooling curve that would promote outgrowth as quickly as possible. The growth 

data suggest that the existing 4-hour TPHC provision will be safe for 6 hours after 

cooking, with the additional 2-hour margin of safety built-in for consumer handling. 

Consumer Handling Practices 

An Audits International study was funded in 1999 by FDA to determine the food 

handling practices of consumers purchasing food at retail and returning home to 

refrigerate their items. Forty-six (46) states are represented, and the data comprises 

several food groups purchased from different grocery-store types. The food groups 

represented were: pre-packaged lunch meat, deli-counter products, seafood, fresh 

meat, pre-packaged deli product, liquid dairy, semi-solid dairy product, ice cream, 

frozen entrées, frozen novelties and whipped topping.

The study evaluated information regarding time and food temperature at retail food 

stores, time to reach home refrigeration, temperature after transport home, location and 

type of retail establishment where purchase was made and type of product purchased. 

For product temperature at retail and after transportation, 5 product categories were 

used: pre packaged lunch meat, pre packaged deli product, deli counter products, 
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 132

seafood and fresh meat. These categories were considered most applicable to the 

TPHC recommendations. The temperature ranges for these products at retail and after 

transport to the home are summarized in Figures 1 and 2 respectively. The data 

suggest that with current retail refrigeration practices, 25% of items are held above 45°F 

(Audits International Figure 1). The data also show that by the time the product arrives 

at the home, 98% of products were at 65°F or less (Audits International Figure 2). 

The time of transport for all food categories from the retail establishment to home 

refrigeration was also recorded. The data summarized in Figure 3 shows that over 97% 

of the foods purchased were ready to be placed in refrigeration within 2 hours of 

purchase. For this histogram, all food categories except for frozen entrées were

included. Because all foods end up bagged and transported together, the time each 

product was transported to the home was considered a valid data point and therefore 

used. Based on the data, a benchmark was established that TCS foods purchased in a 

food establishment would be either consumed, or placed under temperature control, 

within 2 hours.
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 133

Audits International Figure 1. Temperatures of refrigerated products at retail.

0

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FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 134

Audits International Figure 2. Product temperatures after transport to the home. 

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FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 135

Audits International Figure 3. Times reported for transport of grocery items from 

the retail outlet to the home. 

The Safety of the Time as a Public Health Control Provision from Refrigeration 

Temperatures (41°F or less) to Ambient

As noted above, the current TPHC provision has two time provisions. Food can be kept 

with no temperature stipulations for 4 hours in a food establishment, at which time the 

food must be cooked and served, served if RTE, or discarded within the four hours. 

However, if food does not exceed 70°F, it may be held for 6 hours and cooked and 

served, served if RTE or discarded within the six hours. For foods warming from 

refrigeration to ambient temperatures, the data from the Audits International study 

outlined above, along with simulations from the USDA Pathogen Modeling Program 

(PMP), were used to determine the safety of the existing TPHC recommendations. 

Assuming pathogen growth in foods going from refrigeration (41°F or less) to ambient 

temperature, the following parameters were used for the PMP simulation:

• 65°F was used as the temperature for the entire simulation;

• 2 hours were added to all times (4h or 6h) allowed in the current TPHC 

recommendation, to factor in transportation time (per the Audits International 

study outlined above);

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FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 136

• The data were generated from PMP broth models (pH 6.8), with the minimal 

NaCl and no sodium nitrite.

Table 1 summarizes the predicted growth of Bacillus cereus (vegetative), Escherichia 

coli, Listeria monocytogenes, Salmonella spp., Shigella flexneri, and Staphylococcus

aureus, using the PMP and based on the assumptions discussed above. The data 

predicted that less than 1-log growth would be seen for each organism, during the 

8 hour time period. Thus, the data show that the current 4 and 6 hour TPHC provisions 

from 41°F or less to ambient, allow minimal growth of a number of pathogens of 

concern.

3-501.19 Table 1. The USDA Pathogen Modeling Program estimation of growth

(Log CFU/g) of several pathogens for 6 hours or 8 hours, at 65°F.

PATHOGENS 6 HOURS 8 HOURS

B. cereus (vegetative cells) 0.62 0.87

E. coli 0.35 0.52

L. monocytogenes 0.47 0.71

Salmonella Spp. 0.25 0.41

S. flexneri 0.26* 0.34*

S. aureus 0.38* 0.51*

* Model predictions were in 5 hour increments, the 6 and 8 hour data was extrapolated 

between 5 hour and 10 hour predictions.

References

U.S. Department of Agriculture. 1997. Pathogen Modeling Program. USDA Agricultural 

Research Service, Wyndmoor, PA.

Food and Drug Administration. 2006. Growth of Clostridium perfringens inoculated into 

beef roasts and meatloaf (unpublished data).

----------- End of Summary of Consumer Handling Practices study -----------
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 137

Raw eggs

Recipes in which more than one egg is combined carry an increased risk of illness and 

possible serious consequences for certain people. It is due to this increased risk, and 

documented occurrences of foodborne illness and death among highly susceptible 

populations from temperature-abused raw shell eggs contaminated with Salmonella

Enteritidis, that the use of time as a public health control in institutional settings is not 

allowed.

Specialized processing methods

3-502.11 Variance Requirement.

Specific food processes that require a variance have historically resulted in more 

foodborne illness than standard processes. They present a significant health risk if not 

conducted under strict operational procedures. These types of operations may require

the person in charge and food employees to use specialized equipment and 

demonstrate specific competencies. The variance requirement is designed to ensure 

that the proposed method of operation is carried out safely. 

The concept of variances may be new to some regulatory authorities. Some jurisdictions 

may not have a formal process to respond to industry requests for variances, although 

informal allowances may have been allowed in specific situations. Recognizing the 

opportunity to use the variance process may require additional rulemaking, or at least 

policy development, at the jurisdictional level. Rulemaking can be used to outline the 

procedures for a variance request, including the information required in section 8-

103.11. In addition, the rulemaking process can address the regulatory authority’s 

responsibility to consider an industry’s variance application and an appeals process in 

case a variance is not given due consideration or is denied. The Conference for Food 

Protection Variance Committee recommended that regulatory agencies adopt a 

variance review process. General guidance regarding administrative procedures is 

given below.

Regulatory authorities considering implementing variances have encountered issues 

relating to their authority or technical, scientific ability to evaluate or validate a variance 

request. From any variance request there may emerge a set of complex issues and 

scientific competencies beyond the ability of the regulatory authority to validate. The 

Conference for Food Protection Variance Committee recommended that rulemaking 

should reflect a multi-level matrix of regulatory agencies ranging from local regulatory 

authorities through FDA and reflected that recommendation in the following flow chart. 

The regulatory authority is encouraged to seek input and guidance from authoritative 

sources such as processing authorities, professional associations, or academia. Within 

the Variance Committee's model, the process for seeking FDA advice begins with the 

Regional Food Specialists. 

Except for the Interstate Travel Program, FDA generally does not directly regulate retail 

and food service establishments, including entertaining variances for that segment of 

the industry. FDA is still exploring processes for handling variances on a national basis 
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 138

such as those received from national chain businesses. In conjunction with the 2000 

CFP Variance Committee, FDA will continue to explore ways to provide assistance and 

guidance to regulators regarding access to scientific and technical resources in order to 

make science-based decisions regarding variances. 

FDA recommends that regulatory authorities develop a written administrative process 

that is consistent with, and addresses the information contained in, Food Code sections 

8-103.10, 8-103.11, and 8-103.12, and follow a process consistent with the 

recommendations of the CFP Variance Committee as shown in its flow chart. 

3-502.11 Chart 1. A Model Flow Process for State Regulators to Address Variances

Developed by the CFP Variance Committee

Model Administrative Procedures for Regulators to Address Variances

1. Designate an agency team and assign a leader to address variance 

requests.

2. Establish an agency review process leading to approval or denial of 

variance applications. For food safety issues, include 

recommendations for consulting with food processing authorities, 

food scientists, academia, professional organizations, other 

government agencies including the FDA Regional Food Specialist, 

or other experts external to the agency. 
FDA Food Code 2022 Annex 3. Public Health Reasons/Administrative Guidelines

Annex 3 - 139

3. Set reasonable timelines for decision making. Determine if the 

variance application addresses an intrastate or interstate issue. 

a. For variances that have interstate or national implications, 

especially those that address food safety, regulators are 

urged to contact and work closely with their FDA Regional 

Food Specialist to determine if a national policy related to 

the issue exists. Regulators are encouraged to be consistent 

with national policies, guidelines, or opinions. 

b. For variances that address intrastate issues, regulators are 

also encouraged to determine if other State or national 

guidance exists, and to stay consistent with it. 

4. Make the agency’s decision. Inform the applicant. 

a. If the variance request is approved, determine the starting 

date and document all special provisions with which the 

applicant must comply. 

b. If the variance request is denied, inform the applicant as to

the reasons for the denial, the applicant's right to appeal, 

and the appeal process.

5. Inform other interested parties, including the FDA Regional Food 

Specialist. 

a. For variances having interstate or national implications, 

especially those that address food safety, regulators are 

urged to inform their FDA Regional Food Specialist so that 

FDA is aware of, and can appropriately disseminate the 

information regarding food safety variances that may affect 

food establishments in other jurisdictions, such as national 

chains. 

b. For variances that address intrastate issues, regulators are 

encouraged to share the information as if it were an 

interstate issue. 

6. Document all agency actions and decisions in the facility’s file. 

Consider including documentation of special variance provisions on 

the establishment's permit to operate. 

7. If the variance is approved, inform the inspector assigned to that 

facility and train the inspector on the variance provisions, including 

the implementation of the industry’s HACCP plan, if required. 

8. Establish procedures to periodically review the status of the 

variance, determine if it successfully accomplishes its public health 
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objective, and ensure that a health hazard or nuisance does not 

result from its implementation.

9. Establish written procedures for withdrawing approval of the 

variance if it is not successful.

3-502.12 Reduced Oxygen Packaging Without a Variance, Criteria.

Reduced oxygen packaging (ROP) encompasses a large variety of packaging methods 

where the internal environment of the package contains less than the normal ambient 

oxygen level (typically 21% at sea level), including vacuum packaging (VP), modified 

atmosphere packaging (MAP), controlled atmosphere packaging (CAP), cook chill 

processing (CC), and sous vide (SV). Using ROP methods in food establishments has 

the advantage of providing extended shelf life to many foods because it inhibits spoilage 

organisms that are typically aerobic. ROP may also offer benefits related to time and 

labor savings, portion control and quality retention. However, ROP can also increase 

the potential for the growth of certain pathogens in the absence of the growth of 

competing spoilage organisms. For example, if certain controls are not in place, the 

formation of C. botulinum toxin may occur before spoilage renders the product 

unacceptable to the consumer.

The type of food, the production and packaging methods used, and the packaging 

material can impact the level of oxygen present within a package and within the food 

matrix. Combinations of some or all of these variables may result in an oxygen level 

within a package, or within a food matrix, that is less than 21%. While ROP may involve 

different foods and different packaging materials, each process is characterized by the 

deliberate removal of oxygen from or the reduction in the oxygen level in the package or 

the food matrix at the time of packaging. 

Certain foodborne pathogens that are anaerobes or facultative anaerobes are able to 

multiply under either aerobic or anaerobic conditions. Therefore special controls are 

necessary to control their growth. Refrigerated storage temperatures of 5°C (41°F) may 

be adequate to prevent growth and/or toxin production of some pathogenic 

microorganisms but non-proteolytic C. botulinum and L. monocytogenes are able to 

multiply well below 5°C (41°F). For this reason, C. botulinum and L. monocytogenes 

are the pathogens of concern for ROP. Controlling their growth will control the growth of 

other foodborne pathogens as well. 

Reduced Oxygen Packaging with Two Barriers

When followed as written, the ROP methods in this section all provide controls for the 

growth and/or toxin production of C. botulinum and L. monocytogenes without a 

variance. Paragraph 3-502.12 (B) identifies an ROP method with secondary barriers 

that will control C. botulinum and L. monocytogenes when used in conjunction with a 

food storage temperature of 5°C (41°F) or less. These barriers are:

• aw of 0.91 or less;

• pH of 4.6 or less;
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• Cured, USDA inspected meat or poultry products using substances specified in 9 

CFR 424.21; or 

• High levels of competing microorganisms such as those found on raw meat or 

raw poultry or raw vegetables. 

The barriers described above are effective controls for C. botulinum and L. 

monocytogenes in reduced oxygen packaged foods because: 

• C. botulinum will not produce toxin below an aw of 0.91, and the minimum aw for 

growth of L. monocytogenes is 0.92. 

• C. botulinum will not produce toxin when the pH is 4.6 or below and L. 

monocytogenes will generally not grow at this pH under refrigeration 

temperatures.

• Nitrite, used in meat and poultry curing, inhibits the outgrowth of C. botulinum

spores. 

• Most foodborne pathogens do not compete well with other microorganisms.

Therefore foods that have a high level of spoilage organisms or lactic acid 

bacteria that grow under ROP conditions can safely be packaged using ROP and 

held for up to 30 days at 5°C (41°F). 

Other intrinsic or extrinsic factors can also control the growth and/or toxin production of 

C. botulinum and L. monocytogenes.

Foods that are not time/temperature control for safety food (TCS) should not support the 

growth of C. botulinum and L. monocytogenes. Therefore the reduced oxygen 

packaging HACCP requirements of sections 3-502.11 or 3-502.12, apply only to TCS 

foods.

Reduced Oxygen Packaging with One Barrier (Cook-Chill and Sous Vide)

Some foods may not have secondary barriers to prevent the growth of C. botulinum 

and L. monocytogenes, such as aw, pH, nitrite in cured meat products, high levels of 

competing microorganisms or intrinsic factors in certain cheeses. When these foods are 

packaged using a reduced oxygen packaging process, time/temperature becomes the 

critical controlling factor for growth of C. botulinum and L. monocytogenes. Nonproteolytic C. botulinum spores are able to germinate and produce toxin at 

temperatures down to 3oC (38oF). Therefore, holding ROP foods at 3oC (38oF) or less 

should prevent the formation of C. botulinum toxin. L. monocytogenes is able to grow, 

although very slowly, at temperatures down to -1oC (30oF). The lag phase and 

generation time of both pathogens becomes shorter as the storage temperature 

increases. In ¶ 3-502.12(D), cook-chill processing where food is cooked then sealed in 

a barrier bag while still hot and sous vide processing where food is sealed in a barrier 

bag and then cooked, both depend on time/temperature alone as the only barrier to 

pathogenic growth. Therefore, monitoring critical limits including those established for 

cooking to destroy vegetative cells, cooling to prevent outgrowth of spores/toxin 

production, and maintaining cold storage temperatures to inhibit growth and/or toxin 
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production of any surviving pathogens is essential. Four separate options are provided 

in subparagraphs (D)(2)(e). 

These time-temperature combinations will provide equivalent food safety protection 

without need for a variance. (L. monocytogenes will be eliminated by the cooking 

procedures specified in ¶¶3-401.11(A), (B) and (C) and recontamination will be 

prevented by filling the product into the bag while it is still hot (cook-chill) or by cooking 

in the sealed bag (sous vide). C. botulinum will not grow under the specified timetemperature combinations.) 

Since there may not be other controlling factors for C. botulinum and L. 

monocytogenes in a cook-chill or sous vide packaged product, continuous monitoring 

of temperature control and visual examination to verify refrigeration temperatures is 

important. New technology makes it possible to continuously and electronically monitor 

temperatures of refrigeration equipment used to hold cook-chill and sous vide products 

at 1°C (34°F) or 5°C (41°F) or less. Thermocouple data loggers can connect directly 

with commonly available thermocouple probes. Recording charts are also commonly 

used. Temperature monitors and alarm systems will activate an alarm or dialer if 

temperatures rise above preset limits. Nickel-sized data loggers are available to record 

temperatures that can be displayed using computer software. Since surveys have 

shown that temperature control in home kitchens is not always adequate, food 

packaged using cook-chill or sous vide processing methods cannot be distributed 

outside the control of the food establishment doing the packaging. 

Reduced Oxygen Packaging with Cheese

Cheeses, as identified in ¶ 3-502.12(E), that meet the Standards of Identity for hard, 

pasteurized process, and semisoft cheeses in 21 CFR 133.150, 21 CFR 133.169, or 21 

CFR 133.187, respectively, contain various intrinsic factors, often acting synergistically, 

that together act as a secondary barrier to pathogen growth along with refrigerated 

storage at 5°C (41°F) or less. This combination of factors could include some or all of 

the following:

• A lower pH;

• Salt (NaCl) added during processing;

• Low moisture content;

• Added preservatives; and

• Live competing cultures. 

The extended shelf life for vacuum packaged hard and semisoft cheeses is based on 

the intrinsic factors in these cheeses plus the refrigeration temperature of 41°F or less 

to maintain safety. Examples of cheeses that may be packaged under ROP include 

Asiago medium, Asiago old, Cheddar, Colby, Emmentaler, Gruyere, Parmesan, 

Reggiano, Romano, Sapsago, Swiss, pasteurized process cheese, Asiago fresh and 

soft, Blue, Brick, Edam, Gorgonzola, Gouda, Limburger, Monterey, Monterey Jack, 

Muenster, Provolone, and Roquefort. Soft cheeses such as Brie, Camembert, Cottage, 
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and Ricotta may not be packaged under reduced oxygen because of their ability to 

support the growth of L. monocytogenes under modified atmosphere conditions. 

Reduced Oxygen Packaging with Fish

Unfrozen raw fish and other seafood are specifically excluded from ROP at retail 

because of these products’ natural association with non-proteolytic C. botulinum

(primarily type E) which grows at 3oC (37-38oF). ROP of fish and seafood that are 

frozen before, during and after the ROP packaging process does not present this 

hazard.

HACCP Plans with Reduced Oxygen Packaging

A Hazard Analysis and Critical Control Point (HACCP) plan is essential when using 

ROP processing procedures. C. botulinum and L. monocytogenes are potential 

hazards which must be controlled in most TCS foods. Critical control points, critical 

limits, monitoring, record keeping, corrective actions, and verification procedures will 

vary based on the type of food and type of ROP technology used. Developing a 

HACCP plan and providing a copy to the regulatory authority prior to implementation 

provides notice to the regulatory authority that the food establishment intends to 

conduct ROP operations and makes it possible to verify that the appropriate ROP 

procedures are being followed and that the requirements of §3-502.12 are being met.

When a food establishment intends to conduct ROP and hold the product for more than 

48 hours without using one of the secondary barriers defined in section 3-502.12 (the 

criteria specified in paragraph 3-502.12(D) combined with holding the product at 5°C 

(41°F) or less, or hard or semisoft cheeses manufactured using Standards of Identity for 

those cheeses), it is important that an application for a variance (under section 3-

502.11) provide evidence that the ROP methodology intended for use is safe. 

The Relationship Between Time and Reduced Oxygen Packaging

Time is also a factor that must be considered in ROP at retail. The use of date labels on 

VP, MAP, and CAP products and assuring those dates do not exceed the 

manufacturer’s “sell by” or “use by” date is intended to limit the shelf life to a safe time 

period (based on a time in which growth will not occur or involves the presence of two 

barriers to growth). When these ROP products are frozen, there is no longer a restricted 

shelf life. The shelf life limits for cook-chill and sous-vide foods are based on killing all 

vegetative cells in the cooking process, preventing recontamination, and then 

refrigerating at 1°C (34°F) or less for 30 days or 5°C (41°F) or less for 7 days after 

packaging, with stringent temperature monitoring and recording requirements. These 

criteria allow both institutional-sized cook-chill operations that may feed thousands daily, 

often including transportation to their satellite locations, and individual restaurants 

without ice banks and tumble or blast chillers to safely use cook-chill and sous-vide 

processes. 

3-502.12 (F) exempts refrigerated, ROP foods that are always removed from the 

package within 48 hours of packaging from the requirements in section 3-502.12 
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because growth and toxin formation by anaerobic pathogens in that limited time frame is 

not considered a significant hazard in such foods. 

Accurate representation

3-601.11 Standards of Identity.

3-601.12 Honestly Presented.

Labeling

3-602.11 Food Labels.

3-602.12 Other Forms of Information.

The identity of a food in terms of origin and composition is important for instances when 

a food may be implicated in a foodborne illness outbreak and for nutritional information 

requirements. Ingredient information is needed by consumers who have allergies to 

certain food or ingredients. The appearance of a food should not be altered or disguised 

because it is a cue to the consumer of the food's identity and condition.

Food Labels and Other Forms of Information

Food labels serve as a primary means by which consumers can make informed 

decisions about their food selections. Many items in a food establishment are provided 

by the food employee to the consumer upon consumer request. When a consumer 

orders a specific food or specific amount of food from a food employee, that employee 

may put the food in a wrapper or carry-out container at the time the order is placed. This 

food is not considered “packaged”, per the Food Code definition; it was merely wrapped 

or placed in a carry-out container to facilitate service and delivery of the food to the 

consumer in a protected manner. When food is under the direct control of the operator 

and provided to the consumer upon consumer request, the consumer has an 

opportunity to ask about ingredients, nutrients, allergens and weight. 

Alternatively, some food items are enclosed in a container or wrapping for use in the 

display of that item for consumer self-service. In these instances, the label provides an 

important source of information for consumers to answer questions about ingredients, 

allergens, weight, and manufacturer. 

Unintended food allergen food allergen exposures poses a serious risk to consumers 

with food allergies. Consumers with food allergies depend on allergen information that 

is made available either verbally or written by the food establishment. To address 

consumer notification of major food allergens in unpackaged foods served or sold within 

food establishments, the Conference for Food Protection, Issue 2020-II-015, 

recommended that a new provision be added. This provision adds a requirement for the 

permit holder to provide written notification of the presence of major food allergens as 

an ingredient in unpackaged foods that are served or sold by the food establishment. 

Written notification can be provided in many forms such as: physical or electronic 

means, including, but not limited to, brochures, deli case or menu notifications, label 
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statements, table tents, placards, or other effective written means. Notifying the 

consumer to the presence of major food allergens may prevent an inadvertent 

exposure. 

List of Ingredients

A list of ingredients on the label enables a consumer to make an informed decision 

about a packaged food product. Therefore it is important that the list of ingredients 

accurately describe all of the ingredients present in the food. In some instances, an 

ingredient itself may be composed of two or more ingredients, or sub-ingredients. In 

accordance with 21 CFR 101.4(b)(2), the sub-ingredients must be declared on the label. 

One example includes parenthetically listing the individual sub-ingredients in 

descending order of predominance after the common or usual name of the main 

ingredient, as illustrated here: 

Bread pudding ingredients: bread (wheat flour, water, yeast, salt, honey), 

milk, eggs, and sugar 

Another example is to incorporate the common or usual name of each sub ingredient 

into the list of ingredients in descending order of predominance in the finished food 

without listing the main ingredient itself, as illustrated here :

Bread pudding ingredients: milk, wheat flour, water, eggs, sugar, yeast, 

salt, and honey.

Food Allergen Labeling

In 2004, the Food Allergen Labeling and Consumer Protection Act of 2004 (Public Law 

108-282, FALCPA) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to 

provide FDA with additional, specific authority regarding the labeling of a food (other 

than a raw agricultural commodity) that bears or contains a “major food 

allergen.” FALCPA requires that all affected packages of food labeled on or after 

January 1, 2006, identify on the label the names of the food sources of any major food 

allergens (i.e., the following eight foods and any protein derived from them: milk, egg, 

fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans) used as ingredients 

in the food. Providing the name of the food source on the label of packaged foods alerts 

consumers to the presence of a major food allergen and may prevent an inadvertent 

exposure. The names of the food sources are the same as the names of the eight foods 

that are major food allergens, with the exception that for fish, crustacean shellfish, and 

tree nuts, their respective food source names are the specific species of fish (e.g., bass, 

flounder, or cod), the specific species of crustacean shellfish (e.g., crab, lobster, or 

shrimp), and the specific types of tree nuts (e.g., almonds, pecans, or walnuts). 

In April 2021, the Food Allergy Safety, Treatment, Education, and Research Act of 2021 

(FASTER Act) amended section 201(qq) of the FD&C Act to add sesame to the 

definition of “major food allergen.” This amendment applies to “any food that is 

introduced or delivered for introduction into interstate commerce on or after January 1, 

2023 (Public Law 117-11). This amends the “major food allergen” definition as the 
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following: milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybeans and 

sesame. 

Nutrition Labeling

The requirements for nutrition labeling are found in the CFR. The following attempts to 

provide guidance regarding those requirements and exemptions as they relate to the 

retail environment and to alert regulators to authority that has been given to them by the 

Nutrition Labeling and Education Act (NLEA) of 1990. The statute and the CFR should 

be reviewed to ensure a comprehensive understanding of the labeling requirements. 

I. The following foods need not comply with nutrition labeling in the CFR referenced 

in subparagraph 3-602.11(B)(6) if they do not bear a nutrient content claim, health 

claim, or other nutrition information: 

(A) Foods packaged in a food establishment if: 

(1) The food establishment has total annual sales to consumers of 

no more than $500,000 (or no more than $50,000 in food sales 

alone), and

(2) The label of the food does not bear a reference to the 

manufacturer or processor other than the food establishment;

(B) Low-volume packaged food products if: 

(1) The annual sales are less than 100,000 units per product for 

which a notification claiming exemption has been filed with FDA's 

Office of Nutrition and Food Labeling or Office of Dietary 

Supplement Program by a small business with less than 100 fulltime equivalent employees, or

(2) The annual sales are less than 10,000 units per product by a 

small business with less than 10 full-time equivalent employees;

(C) Except as provided in 21 CFR 101.11, foods served in food 

establishments with facilities for immediate consumption such as 

restaurants, cafeterias, and mobile food establishments, and foods sold 

only in those establishments;

(D) Except as provided in 21 CFR 101.11, foods similar to those 

specified in the preceding bullet but that are sold by food establishments 

without facilities for immediate consumption such as bakeries and grocery 

stores if the food is: 

(1) Ready-to-eat but not necessarily for immediate consumption,

(2) Prepared primarily in the food establishment from which it is 

sold, and
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(3) Not offered for sale outside the food establishment;

(E) Except as provided in 21 CFR 101.11, foods of no nutritional 

significance such as coffee;

(F) Bulk food for further manufacturing or repacking; and

(G) Raw fruits, vegetables, and fish. 

II. Game animal meats shall provide nutrition information which may be provided by 

labeling displayed at the point of purchase such as on a counter card, sign, tag 

affixed to the food, or some other appropriate device. 

III. Food packaged in a food processing plant or another food establishment, shall 

meet the requirements specified in § 3-602.11 and enforcement by the regulatory 

authority is authorized in the NLEA, Section 4. State Enforcement. 

Canthaxanthin and Astaxanthin

Canthaxanthin and Astaxanthin are color additives for salmonid fish. According to the 

FDA Regulatory Fish Encyclopedia, the family Salmonidae includes pink salmon, coho 

salmon, sockeye salmon, chinook salmon, Atlantic salmon, chum salmon, rainbow trout, 

cutthroat trout, and brown trout. These color additives may be in the feed that is fed to 

aquacultured fish. When those fish are placed into a bulk container for shipment, the 

bulk container will bear a label declaring the presence of canthaxanthin. 

Providing this information on the label of fish packaged and offered for sale at retail will 

inform the consumer of the presence of these additives: 

21 CFR 73.75 promulgates requirements for the use of canthaxanthin in 

salmonid fish. 

21 CFR 73.35 promulgates requirements for the use of astaxanthin in salmonid 

fish. For additional information, see the Federal Register announcement 63 FR 

14814, March 27, 1998, Listing of Color Additives Exempt from Certification, 

Canthaxanthin.

Safe Handling Instructions 

Refer to public health reason for § 3-201.11 Labeling for Meat and Poultry.

Consumer advisory

3-603.11 Consumption of Raw or Undercooked Animal Foods.

Refer to the public health reason for § 3-401.11. 

Purpose:

At issue is the role of government agencies, the regulated industry, and others in 

providing notice to consumers that animal-derived foods that are not subjected to 

adequate heat treatment pose a risk because they may contain biological agents that 
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cause foodborne disease. The deliverance of a balanced message that communicates 

fairly to all consumers and, where epidemiologically supported, attempts to place risk in 

perspective based on the consumer's health status and the food being consumed is part 

of the challenge. Notification of risk must be achieved via a meaningful message and in 

a manner that is likely to affect behavior. The following information is to alert the reader 

to the options available to food establishments in advising consumers of the increased 

possibility of foodborne illness when animal-derived foods are eaten raw or 

undercooked. 

Background:

Although no specific advisory language was recommended, beginning with the 1993 

Food Code, FDA included a codified provision for a point-of-purchase consumer 

advisory and stated in Annex 3: 

"FDA has requested comments and will consider the responses as well as 

other information that is available related to the risks involved and 

methods of risk communication to determine what action may be 

necessary by FDA to effectively inform consumers." 

Consumer Focus Groups:

During 1996 - 1998, FDA conducted two different consumer focus group studies. 

Because the first set of focus groups (conducted before the 1997 Code) were not 

receptive to the language recommended at the 1996 Conference for Food Protection 

(CFP) meeting, that language was not included in the 1997 Code. Before the 1998 CFP 

meeting, the Agency convened a second set of focus groups with a modified approach. 

The latter set expressed similar thoughts as those in the earlier set and a pattern for 

consumer acceptance and receptiveness to menu-based advisories emerged. 

It became apparent that there is a general appreciation for "disclosure" of what 

consumers view as "hidden ingredients, " for example, whether a particular menu item 

contains raw egg. In addition to disclosure being viewed as helpful, consumers are 

accepting, if not appreciative, of a "reminder" that consuming raw or undercooked 

animal-derived foods carries an increased risk of foodborne illness. In the food 

establishment venue, consumers are less willing to accept a message that extends 

beyond a reminder and becomes a lesson or an educational message. 

Satisfactory Compliance:

FDA submitted to the 1998 CFP meeting an Issue that asked the Conference to discuss 

an approach that incorporated the knowledge obtained from the consumer testing. It 

was the consensus of the CFP that satisfactory compliance with the Code’s 

consumer advisory provision is fulfilled when both a disclosure and reminder are 

provided, as described in § 3-603.11 of the Code. Disclosure is achieved when there 

is clear identification of animal-derived foods that are sold or served raw or 

undercooked, and of items that either contain or may contain (to allow for ingredient 

substitution) such raw or undercooked ingredients. A third option for the consumer 
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“reminder” was added later. The reminder is a notice about the relationship between 

thorough cooking and food safety. 

Two options were endorsed for disclosure and two for the reminder. One of the 

reminder options is a menu statement that advises consumers that food safety 

information about the disclosed items is available upon request. Essential criteria for 

such written information are available from FDA through the Retail Food Protection 

Team by writing to: FDA/CFSAN, 5100 Paint Branch Parkway, (HFS-320) College Park, 

Maryland 20740. All brochures must meet these essential criteria. The other option is a 

short notice alerting consumers to the increased risk of consuming the disclosed menu 

items. 

In response to concerns raised by the Interstate Shellfish Sanitation Conference (ISSC) 

in an October 8, 1998 letter to FDA, a third option has been added to allow for a 

statement that links an increased risk of illness to consumption of raw or undercooked 

animal foods by persons with certain medical conditions. 

The information contained in both the disclosure and reminder should be publicly 

available and readable so that consumers have benefit of the total message (disclosure 

and reminder) before making their order selections. 

It is not possible to anticipate all conceivable situations. Therefore, there will always be 

need for discussion between the food establishment and the Regulatory Authority as to 

the most effective way to meet the objectives of satisfactory compliance.

The Implementation Guidance for the Consumer Advisory Provision of the FDA Food 

Code (section 3-603.11 in the FDA Model Food Code), is a resource intended to assist 

regulators and industry in the implementation of the Consumer Advisory provision. It is 

recommended that it be used in conjunction with the FDA Food Code. It is available 

from FDA through the Retail Food Protection Team by writing to: FDA/CFSAN, 5100 

Paint Branch Parkway, (HFS-320) College Park, Maryland 20740. 

Locating the Advisory:

Disclosure of raw or undercooked animal-derived foods or ingredients and reminders 

about the risk of consuming such foods belong at the point where the food is selected 

by the consumer. Both the disclosure and the reminder need to accompany the 

information from which the consumer makes a selection. That information could appear 

in many forms such as a menu, a placarded listing of available choices, or a table tent. 

Educational Messages:

Educational messages are usually longer, more didactic in nature, and targeted to 

consumers who have been alerted to the food safety concern and take the initiative to 

obtain more detailed information. It is expected that, in most cases, educational 

messages that are provided pursuant to § 3-603.11 (i.e., in situations where the option 

for referring the consumer to additional information is chosen), will be embodied in 

brochures that will not be read at the site where the immediate food choice is being 

made. Nonetheless, such messages are viewed as an important facet of arming 
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consumers with the information needed to make informed decisions and, because the 

information is being requested by the consumer, it would be expected to play a role in 

subsequent choices.

Applicability:

Food Establishments:

The consumer advisory is intended to apply to all food establishments where raw or 

undercooked animal foods or ingredients are sold or served for human consumption in a 

raw or undercooked form. This includes all types of food establishments whenever there 

is a reasonable likelihood that the food will be consumed without subsequent, thorough 

cooking - such as restaurants, raw bars, quick-service operations, carry-outs, and sites 

where groceries are obtained that have operations such as delicatessens or seafood 

departments. 

"... Otherwise Processed to Eliminate Pathogens... ":

This phrase is included in § 3-603.11 to encompass new technologies and pathogen 

control/reduction regimens as they are developed and validated as fulfilling a specific 

performance standard for pathogens of concern. Pasteurization of milk is an example of 

a long-standing validated process. For purposes of the Food Code, the level of 

pathogen reduction that is required before a raw or undercooked animal food is allowed 

to be offered without a consumer advisory must be equivalent to the levels provided by 

§ 3-401.11 for the type of food being prepared. 

The absorbed dose levels of radiation approved by FDA on December 3, 1997 for red 

meat are insufficient to reduce the level of most vegetative pathogens to a point that is 

equivalent to the reductions achieved in ¶¶ 3-401.11(A) and (B). Irradiated poultry 

provides a 3D kill which does not provide the level of protection of the 7D kill that results 

from the cooking regimen in the Food Code. Therefore, irradiated meat and poultry are 

not allowed to be offered in a ready-to-eat form without a consumer advisory. It is 

intended that future Food Code revisions will address time/temperature requirements 

that take into consideration the pathogen reduction that occurs with irradiated foods.

Recognition of Other Processes:

Animal-derived foods may undergo validated processes that target a specific pathogen. 

In such instances, along with the required consumer advisory may appear additional 

language that accurately describes the process and what it achieves. For example, a 

technology for reducing Vibrio vulnificus in oysters to nondetectable levels has been 

validated. FDA concurs that shellfish subjected to that process can be labeled with a 

truthful claim that appropriately describes the product. That is, a statement could be 

made such as, "pasteurized to reduce Vibrio vulnificus" or "temperature treated to 

reduce Vibrio vulnificus. " Such a claim must be in accordance with labeling laws and 

regulations, accurate, and not misleading. The claim would not, however, negate the 

need for a consumer advisory because the treatment only reduces the level of one 

pathogenic organism.
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Product-specific Advisories:

Consumer advisories may be tailored to be product-specific if a food establishment 

either has a limited menu or offers only certain animal-derived foods in a raw or 

undercooked ready-to-eat form. For example, a raw bar serving molluscan shellfish on 

the half shell, but no other raw or undercooked animal food, could elect to confine its 

consumer advisory to shellfish. The raw bar could also choose reminder, option #3, 

which would highlight the increased risk incurred when persons with certain medical 

conditions ingest shellfish that has not been adequately heat treated. 

Terminology:

It should be noted that the actual on-site (e.g., on-the-menu) advisory language differs 

from the language in the codified provision, § 3-603.11. In the insert page for 

§ 3-603.11, the Reminder options 2 and 3 use terms for foods that are less specific 

than the terms used in the actual code section. That is, the words “meat” rather than 

“beef, lamb, and pork” and “seafood” rather than “fish” are used. Categorical terms like 

“meat” are simpler and may be more likely used in conversation, making them suitable 

for purposes of a menu notice. 

Milk:

In addition, “milk” is not mentioned in the actual on-site advisory language. The sale or 

transportation of final packaged form of unpasteurized milk into interstate commerce is 

specifically prohibited by 21 CFR 1240.61. Also the consumption of raw milk is not 

recommended by FDA (this statement is in the form of an official FDA position 

statement found at 

http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformatio

n/Milk/ucm2007973.htm. Nonetheless, approximately 25 states allow unpasteurized 

milk in intrastate commerce which usually involves direct dairy farm-to-consumer 

procurement. 

In the event that a food establishment governed by § 3-603.11 of this Code operates in 

conjunction with a dairy farm in a State that allows the in-State sale or service of 

unpasteurized milk, or in the case where a State allows unpasteurized milk to be 

marketed via retail-level food establishments, consumers need to be advised of the risk 

associated with drinking unpasteurized milk. In these situations, the actual advisory 

language needs to be amended to include milk (refer to Consumer Advisory Reminder, 

paragraph 3-603.11(C), options 2 or 3). 

Molluscan Shellstock:

In addition to areas of retail food stores such as delis in supermarkets, the consumer 

advisory is to be provided when a seafood department or seafood market offers raw 

molluscan shellstock for sale or service. There is a risk of death from Vibrio infections 

from consuming raw molluscan shellstock for persons who have certain medical 

conditions. 
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Disposition

3-701.11 Discarding or Reconditioning Unsafe, Adulterated, or 

Contaminated Food.

Pathogens may be transmitted from person to person through contaminated food. The 

potential spread of illness is limited when food is discarded if it may have been 

contaminated by employees who are infected, or are suspected of being infected, or by 

any person who otherwise contaminates it. 

Additional safeguards

3-801.11 Pasteurized Foods, Prohibited Re-Service, and Prohibited 

Food. 

Refer to the public health reason for § 3-201.11. 

The Code provisions that relate to highly susceptible populations are combined in this 

section for ease of reference and to add emphasis to special food safety precautions 

that are necessary to protect those who are particularly vulnerable to foodborne illness 

and for whom the implications of such illness can be dire. 

As a safeguard for highly susceptible populations from the risk of contracting foodborne 

illness from juice, prepackaged juice is required to be obtained pasteurized or in a 

commercially sterile, shelf-stable form in a hermetically sealed container. It is important 

to note that the definition of a “juice” means it is served as such or used as an ingredient 

in beverages. Puréed fruits and vegetables, which are commonly prepared as food for 

service to highly susceptible populations, are not juices and do not require HACCP 

plans or compliance with 21 CFR Part 120. There are documented cases of foodborne 

illness throughout the United States that were associated with the consumption of 

various juice products contaminated with microorganisms such as Cryptosporidium, 

Shiga toxin-producing Escherichia coli, Salmonella spp., and Vibrio cholera. As new 

information becomes available, the Food Code will be modified or interim interpretive 

guidance will be issued regarding foodborne illness interventions for on-site juicing and 

puréeing. 

The 21 CFR 120 regulation applies to products sold as juice or used as an ingredient in 

beverages. This includes fruit and vegetable purees that are used in juices and 

beverages, but is not intended to include freshly prepared fruit or vegetable purees that 

are prepared on-site in a facility for service to a highly susceptible population. 

In lieu of meeting the requirements of 21 CFR 120, juices that are produced as 

commercially sterile products (canned juices) are acceptable for service to a highly 

susceptible population. Persons providing pureed meals to highly susceptible 

populations may also wish to use fruit and vegetables that are produced as 

commercially sterile products (canned fruit or vegetables) as a means of enhancing 

food safety. 
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Salmonella often survives traditional preparation techniques. It survives in a lightly 

cooked omelet, French toast, stuffed pasta, and meringue pies. In 1986 there was a 

large multistate outbreak of Salmonella Enteritidis traced to stuffed pasta made with 

raw eggs and labeled "fully cooked." Eggs remain a major source of these infections, 

causing large outbreaks when they are combined and undercooked as was the case in 

the 1986 outbreak linked to stuffed pasta. Therefore, special added precautions need to 

be in place with those most susceptible to foodborne illness. 

Operators of food establishments serving highly susceptible populations may wish to 

discuss buyer specifications with their suppliers. Such specifications could stipulate 

eggs that are produced only by flocks managed under a Salmonella Enteritidis control 

program that is recognized by a regulatory agency that has animal health jurisdiction. 

Such programs are designed to reduce the presence of Salmonella Enteritidis in raw 

shell eggs. In any case, the food establishment operator must use adequate time and 

temperature controls within the establishment to minimize the risk of a foodborne illness 

outbreak relating to Salmonella Enteritidis. 

Since 1995, raw seed sprouts have emerged as a recognized source of foodborne 

illness in the United States. The FDA and CDC have issued health advisories that 

persons who are at a greater risk for foodborne disease should avoid eating raw alfalfa

sprouts until such time as intervention methods are in place to improve the safety of 

these products. Further information is available at the FDA website, http://www.fda.gov, 

by entering “sprouts” in the search window. 

Although the Code’s allowance for the Regulatory Authority to grant a variance (refer to 

§§ 8-103.10 - .12, 8-201.14, and 8-304.11) is applicable to all Code provisions, variance 

requests related to the preparation of food for highly susceptible populations must be 

considered with particular caution and scrutiny. With all variances, the hazard(s) must 

be clearly identified and controlled by a HACCP plan that is instituted in conjunction with 

a standard operating plan that implements good retail practices. Variances that will 

impact a highly susceptible population must be considered in light of the fact that such a 

population is at a significantly higher risk of contracting foodborne illnesses and 

suffering serious consequences including death from those illnesses, than is the general 

population. 

Subparagraph 3-801.11(F)(3) requires a HACCP plan for the use of raw shell eggs 

when eggs are combined in food establishments serving highly susceptible populations. 

A variance is not required since the HACCP plan criteria are specific, prescriptive, and 

conservative and require a cooking temperature and time to ensure destruction of 

Salmonella Enteritidis. 

3-801.11(G) and (H) Re-service of food

The Food Code addresses two issues concerning persons in isolation: 

1. Contamination from an isolated patient to others outside.

The re-service of any food including unopened, original, intact packages in sound 
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condition, of non-temperature controlled for safety food from a person in isolation 

or quarantine for use by anyone else (other patients, clients, or consumers) is not

permitted. The “isolation or quarantine” terminology in the Code text refers to a 

patient-care setting that isolates the patient, thereby preventing spread of key 

pathogens to other patients and healthcare workers. Once food packages come 

to a contact isolation room, they stay there until the patient uses or discards 

them. If packages of food are still in the room when the patient is discharged or 

moved from isolation, they must be discarded.

2. Contamination from the outside into a room with a patient in a “protective 

environment” isolation setting which protects the patient from contacting 

pathogens from other patients, healthcare workers, or other persons. 

Packages of food from any patients, clients or other consumers should not be reserved to persons in protective environment isolation. Precautions similar to the 

isolation setting apply to this setting, i.e., once an unopened, original, intact 

package of condiment is delivered to this patient, the package stays there until 

used or discarded. New (not re-served) packages of food should be delivered to 

this patient each time. 

To summarize the key difference between the two scenarios:

• Food packages served to patients in contact isolation may not be re-served to 

other patients because of the potential for disease transmission to other patients. 

• Patients in protective environments should not be re-served with food packages 

from other patients because of the potential for disease transmission to the 

protective environment patient.
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Chapter 4. Equipment, Utensils, and Linens

Multiuse 

4-101.11 Characteristics.

Multiuse equipment is subject to deterioration because of its nature, i.e., intended use 

over an extended period of time. Certain materials allow harmful chemicals to be 

transferred to the food being prepared which could lead to foodborne illness. In addition, 

some materials can affect the taste of the food being prepared. Surfaces that are unable 

to be routinely cleaned and sanitized because of the materials used could harbor 

foodborne pathogens. Deterioration of the surfaces of equipment such as pitting may 

inhibit adequate cleaning of the surfaces of equipment, so that food prepared on or in 

the equipment becomes contaminated. 

Inability to effectively wash, rinse and sanitize the surfaces of food equipment may lead 

to the buildup of pathogenic organisms transmissible through food. Studies regarding 

the rigor required to remove biofilms from smooth surfaces highlight the need for 

materials of optimal quality in multiuse equipment.

 4-101.12 Cast Iron, Use Limitation.

Equipment and utensils constructed of cast iron meet the requirement of durability as 

intended in section 4-101.11. However, the surface characteristics of cast iron tend to 

be somewhat porous which renders the material difficult to clean. On the other hand, 

when cast iron use is limited to cooking surfaces the residues in the porous surface are 

not of significant concern as heat destroys potential pathogens that may be present. 

4-101.13 Lead, Use Limitation. 

Historically, lead has been used in the formulation or decoration of these types of

utensils. Specifically, lead-based paints that were used to decorate the utensils such as 

color glazes have caused high concentrations of lead to leach into the food they 

contain. 

Lead poisoning continues to be an important public health concern due to the 

seriousness of associated medical problems. Lead poisoning is particularly harmful to 

the young and has caused learning disabilities and medical problems among individuals 

who have consumed high levels. The allowable levels of lead are specific to the type of 

utensil, based on the average contact time and properties of the foods routinely stored 

in each item listed. 

FDA has established maximum levels (see FDA Compliance Policy Guide Section 

545.450 Pottery (Ceramics); Imported and Domestic – Lead Contamination (CPG 

7117.07) for leachable lead in ceramicware, and pieces that exceed these levels are 

subject to recall or other agency enforcement action. The levels are based on how 

frequently a piece of ceramicware is used, the type and temperature of the food it holds, 

and how long the food stays in contact with the piece. For example, cups, mugs, and 

pitchers have the most stringent action level, 0.5 parts per million, because they can be 
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expected to hold food longer, allowing more time for lead to leach. Also, a pitcher may 

be used to hold fruit juice. And a coffee mug is generally used every day to hold a hot 

acidic beverage, often several times a day. 

The FDA allows use of lead glazes because they’re the most durable, but regulates 

them tightly to ensure their safety. Commercial manufacturers employ extremely strict 

and effective manufacturing controls that keep the lead from leaching during use. Small 

potters often can’t control the firing of lead glazes as well so their ceramics are more 

likely to leach illegal lead levels, although many do use lead-free glazes. 

In 21 CFR 109.16, FDA requires high-lead-leaching decorative ceramicware to be 

permanently labeled that it’s not for food use and may poison food. Such items bought 

outside the United States may not be so labeled, potentially posing serious risk if used 

for food. 

Pewter refers to a number of silver-gray alloys of tin containing various amounts of 

antimony, copper, and lead. The same concerns about the leaching of heavy metals 

and lead that apply to brass, galvanized metals, copper, cast iron, ceramics, and crystal 

also apply to pewter. As previously stated, the storage of acidic moist foods in pewter 

containers could result in food poisoning (heavy metal poisoning). 

Solder is a material that is used to join metallic parts and is applied in the melted state 

to solid metals. Solder may be composed of tin and lead alloys. 

4-101.14 Copper, Use Limitation.

High concentrations of copper are poisonous and have caused foodborne illness. When 

copper and copper alloy surfaces contact acidic foods, copper may be leached into the 

food. Carbon dioxide may be released into a water supply because of an ineffective or 

nonexistent backflow prevention device between a carbonator and copper plumbing 

components. The acid that results from mixing water and carbon dioxide leaches copper 

from the plumbing components and the leachate is then transferred to beverages, 

causing copper poisoning. Backflow prevention devices constructed of copper and 

copper alloys can cause, and have resulted in, the leaching of both copper and lead into 

carbonated beverages. 

Brass is an alloy of copper and zinc and contains lead which is used to combine the two 

elements. Historically, brass has been used for items such as pumps, pipe fitting, and 

goblets. All 3 constituents are subject to leaching when they contact acidic foods, and 

food poisoning has resulted from such contact. 

The steps in beer brewing include malting, mashing, fermentation, separation of the 

alcoholic beverage from the mash, and rectification. During mashing, it is essential to 

lower the pH from its normal 5.8 in order to optimize enzymatic activity. The pH is 

commonly lowered to 5.1-5.2, but may be adjusted to as low as 3.2. The soluble extract 

of the mash (wort) is boiled with hops for 1 to 22 hours or more. After boiling, the wort is 

cooled, inoculated with brewers yeast, and fermented. The use of copper equipment 
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during the prefermentation and fermentation steps typically result in some leaching of 

copper. 

Because copper is an essential nutrient for yeast growth, low levels of copper are 

metabolized by the yeast during fermentation. However, studies have shown that 

copper levels above 0.2 mg/L are toxic or lethal to the yeast. In addition, copper levels 

as low as 3.5 mg/L have been reported to cause symptoms of copper poisoning in 

humans. Therefore, the levels of copper necessary for successful beer fermentation 

(i.e., below 0.2 mg/L) do not reach a level that would be toxic to humans. 

Today, domestic beer brewers typically endeavor to use only stainless steel or stainless 

steel-lined copper equipment (piping, fermenters, filters, holding tanks, bottling 

machines, keys, etc.) in contact with beer following the hot brewing steps in the beer 

making process. Some also use pitch-coated oak vats or glass-lined steel vats following 

the hot brewing steps. Where copper equipment is not used in beer brewing, it is 

common practice to add copper (along with zinc) to provide the nutrients essential to the 

yeast for successful fermentation. 

4-101.15 Galvanized Metal, Use Limitation.

Galvanized means iron or steel coated with zinc. Metals such as iron and steel are 

coated with zinc to prevent rusting. Under certain conditions, zinc may leach from 

galvanized food-contact surfaces into foods that are high in water content. The risk of 

leaching increases with increased acidity of foods contacting the galvanized foodcontact surface. On contact with acidic foods and beverages, the zinc may be converted 

to zinc salts which are readily absorbed by the body

Zinc is generally considered to be non-toxic, and in fact is a required mineral for many 

processes that occur in the human body. However, zinc is known to be toxic when 

ingested in large quantities. Symptoms of zinc poisoning include vomiting, nausea, 

lethargy, fatigue, and epigastric pain. Most reports of zinc poisoning implicate 

contaminated food that resulted from storage in a galvanized metal container. 

Also see http://www.cdc.gov/mmwr/preview/mmwrhtml/00000082.htm

4-101.16 Sponges, Use Limitation.

Sponges are difficult, if not impossible, to clean once they have been in contact with 

food particles and contaminants that are found in the use environment. Because of their 

construction, sponges provide harborage for any number and variety of microbiological 

organisms, many of which may be pathogenic. Therefore, sponges are to be used only 

where they will not contaminate cleaned and sanitized or in-use, food-contact surfaces 

such as for cleaning equipment and utensils before rinsing and sanitizing. 

4-101.17 Wood, Use Limitation.

The limited acceptance of the use of wood as a food-contact surface is determined by 

the nature of the food and the type of wood used. Moist foods may cause the wood 

surface to deteriorate and the surface may become difficult to clean. In addition, wood 
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that is treated with preservatives may result in illness due to the migration of the 

preservative chemicals to the food; therefore, only specific preservatives are allowed.

4-101.18 Nonstick Coatings, Use Limitation. 

Perfluorocarbon resin is a tough, nonporous and stable plastic material that gives 

cookware and bakeware a surface to which foods will not stick and that cleans easily 

and quickly. FDA has approved the use of this material as safe for food-contact 

surfaces. The Agency has determined that neither the particles that may chip off nor the 

fumes given off at high temperatures pose a health hazard. However, because this 

nonstick finish may be scratched by sharp or rough-edged kitchen tools, the 

manufacturer's recommendations should be consulted and the use of utensils that may 

scratch, abrasive scouring pads, or cleaners avoided. 

4-101.19 Nonfood-Contact Surfaces. 

Nonfood-contact surfaces of equipment routinely exposed to splash or food debris are 

required to be constructed of nonabsorbent materials to facilitate cleaning. Equipment 

that is easily cleaned minimizes the presence of pathogenic organisms, moisture, and 

debris and deters the attraction of rodents and insects. 

Single-service and single-use

4-102.11 Characteristics.

The safety and quality of food can be adversely affected through single service and 

single use articles that are not constructed of acceptable materials. The migration of 

components of those materials to food they contact could result in chemical 

contamination and illness to the consumer. In addition, the use of unacceptable 

materials could adversely affect the quality of the food because of odors, tastes, and 

colors transferred to the food.

Durability and strength

4-201.11 Equipment and Utensils.

Equipment and utensils must be designed and constructed to be durable and capable of 

retaining their original characteristics so that such items can continue to fulfill their 

intended purpose for the duration of their life expectancy and to maintain their easy 

cleanability. If they can not maintain their original characteristics, they may become 

difficult to clean, allowing for the harborage of pathogenic microorganisms, insects, and 

rodents. Equipment and utensils must be designed and constructed so that parts do not 

break and end up in food as foreign objects or present injury hazards to consumers. A 

common example of presenting an injury hazard is the tendency for tines of poorly 

designed single service forks to break during use. 
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4-201.12 Food Temperature Measuring Devices.

Food temperature measuring devices that have glass sensors or stems present a 

likelihood that glass will end up in food as a foreign object and create an injury hazard to 

the consumer. In addition, the contents of the temperature measuring device, e.g., 

mercury, may contaminate food or utensils. 

Cleanability

4-202.11 Food-Contact Surfaces.

The purpose of the requirements for multiuse food-contact surfaces is to ensure that 

such surfaces are capable of being easily cleaned and accessible for cleaning. Foodcontact surfaces that do not meet these requirements provide a potential harbor for 

foodborne pathogenic organisms. Surfaces which have imperfections such as cracks, 

chips, or pits allow microorganisms to attach and form biofilms. Once established, these 

biofilms can release pathogens to food. Biofilms are highly resistant to cleaning and 

sanitizing efforts. The requirement for easy disassembly recognizes the reluctance of 

food employees to disassemble and clean equipment if the task is difficult or requires 

the use of special, complicated tools.

4-202.12 CIP Equipment.

Certain types of equipment are designed to be cleaned in place (CIP) where it is difficult 

or impractical to disassemble the equipment for cleaning. Because of the closed nature 

of the system, CIP cleaning must be monitored via access points to ensure that 

cleaning has been effective throughout the system. 

The CIP design must ensure that all food-contact surfaces of the equipment are 

contacted by the circulating cleaning and sanitizing solutions. Dead spots in the system, 

i.e., areas which are not contacted by the cleaning and sanitizing solutions, could result 

in the buildup of food debris and growth of pathogenic microorganisms. There is equal 

concern that cleaning and sanitizing solutions might be retained in the system, which 

may result in the inadvertent adulteration of food. Therefore, the CIP system must be 

self-draining. 

4-202.13 "V" Threads, Use Limitation.

V-type threads present a surface which is difficult to clean routinely; therefore, they are 

not allowed on food-contact surfaces. The exception provided for hot oil cooking fryers 

and filtering systems is based on the high temperatures that are used in this equipment. 

The high temperature in effect sterilizes the equipment, including debris in the "V" 

threads. 

4-202.14 Hot Oil Filtering Equipment.

To facilitate and ensure effective cleaning of this equipment, Code requirements, 

§§ 4-202.11 and 4-202.12 must be followed. The filter is designed to keep the oil free of 

undesired materials and therefore must be readily accessible for replacement. Filtering 
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the oil reduces the likelihood that off-odors, tastes, and possibly toxic compounds may 

be imparted to food as a result of debris buildup. To ensure that filtering occurs, it is 

necessary for the filter to be accessible for replacement. 

4-202.15 Can Openers.

Once can openers become pitted or the surface in any way becomes uncleanable, they 

must be replaced because they can no longer be adequately cleaned and sanitized. 

Can openers must be designed to facilitate replacement. 

4-202.16 Nonfood-Contact Surfaces.

Hard-to-clean areas could result in the attraction and harborage of insects and rodents 

and allow the growth of foodborne pathogenic microorganisms. Well-designed 

equipment enhances the ability to keep nonfood-contact surfaces clean. 

4-202.17 Kick Plates, Removable.

The use of kick plates is required to allow access for proper cleaning. If kick plate 

design and installation does not meet Code requirements, debris could accumulate and 

create a situation that may attract insects and rodents. 

Accuracy

4-203.11 Temperature Measuring Devices, Food.

The Metric Conversion Act of 1975 (amended 1988, 1996, and 2004, 15 USC 205a et 

seq) requires that all Federal government regulations use the Celsius scale for 

temperature measurement. The Fahrenheit scale is included in the Code for those 

jurisdictions using the Fahrenheit scale for temperature measurement. 

The small margin of error specified for thermometer accuracy is due to the lack of a 

large safety margin in the temperature requirements themselves. The accuracy 

specified for a particular food temperature measuring device is applicable to its entire 

range of use, that is, from refrigeration through cooking temperatures if the device is 

intended for such use. 

4-203.12 Temperature Measuring Devices, Ambient Air and Water.

A temperature measuring device used to measure the air temperature in a refrigeration 

unit is not required to be as accurate as a food thermometer because the unit's 

temperature fluctuates with repeated opening and closing of the door and because 

accuracy in measuring internal food temperatures is of more significance. 

The Celsius scale is the federally recognized scale based on The Metric Conversion Act 

of 1975 (amended 1988, 1996, and 2004, 15 USC 205a et seq) which requires the use 

of metric values. The ±1.5oC requirement is more stringent than the 3oF previously 

required since ±1.5oC is equivalent to ±2.7oF. The more rigid accuracy results from the 
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practical application of metric equivalents to the temperature gradations of Celsius 

thermometers. 

If Fahrenheit thermometers are used, the 3oF requirement applies because of the 

calibrated intervals of Fahrenheit thermometers. 

The accuracy specified for a particular air or water temperature measuring device is 

applicable to its intended range of use. For example, a cold holding unit may have a

temperature measuring device that measures from a specified frozen temperature to 

20oC (68oF). The device must be accurate to specifications within that use range. 

4-203.13 Pressure Measuring Devices, Mechanical 

Warewashing Equipment. 

Flow pressure is a very important factor with respect to the efficacy of sanitization. A 

pressure below the design pressure results in inadequate spray patterns and 

incomplete coverage of the utensil surfaces to be sanitized. Excessive flow pressure will 

tend to atomize the water droplets needed to convey heat into a vapor mist that cools 

before reaching the surfaces to be sanitized. 

Functionality

4-204.11 Ventilation Hood Systems, Drip Prevention.

The dripping of grease or condensation onto food constitutes adulteration and may 

involve contamination of the food with pathogenic organisms. Equipment, utensils, 

linens, and single service and single use articles that are subjected to such drippage are 

no longer clean. 

4-204.12 Equipment Openings, Closures and Deflectors.

Equipment openings and covers must be designed to protect stored or prepared food 

from contaminants and foreign matter that may fall into the food. The requirement for an 

opening to be flanged upward and for the cover to overlap the opening and be sloped to 

drain prevents contaminants, especially liquids, from entering the food-contact area.

Some equipment may have parts that extend into the food-contact areas. If these parts 

are not provided with a watertight joint at the point of entry into the food-contact area, 

liquids may contaminate the food by adhering to shafts or other parts and running or 

dripping into the food. 

An apron on parts extending into the food-contact area is an acceptable alternative to 

the watertight seal. If the apron is not properly designed and installed, condensation, 

drips, and dust may gain access to the food. 

4-204.13 Dispensing Equipment, Protection of Equipment and Food.

This requirement is intended to protect both the machine-dispensed, unpackaged, liquid 

foods and the machine components from contamination. Barriers need to be provided 
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so that the only liquid entering the food container is the liquid intended to be dispensed 

when the machine's mechanism is activated. Recessing of the machine's components 

and self-closing doors prevent contamination of machine ports by people, dust, insects, 

or rodents. If the equipment components become contaminated, the product itself will 

be exposed to possible contamination.

A direct opening into the food being dispensed allows dust, vermin, and other 

contaminants access to the food. 

NSF/ANSI 18-Manual Food and Beverage Dispensing Equipment is the standard for 

manual food and beverage dispensing equipment which has been designed to maintain 

the safety of aseptically packaged fluid foods without refrigeration even after the 

hermetic seal is broken. 

NSF/ANSI 18 was revised in 2006 to specifically address dispensing equipment 

designed to hold time/temperature control for safety food or beverages in a 

homogeneous liquid form without temperature control. NSF/ANSI 18 requires that such 

equipment designs include a number of safeguards that prevent the contamination of 

specially packaged food stored within the dispensing equipment. The Standard also 

requires that the dispensing equipment have lockout mechanisms that preclude the 

dispensing of the product if such safeguards fail or if a prescribed duration of storage is 

exceeded. 

The American National Standards Institute (ANSI) recognizes NSF/ANSI 18 as the sole 

American National Standard for the sanitary design of manual food and beverage 

dispensers. 

4-204.14 Vending Machine, Vending Stage Closure.

Since packaged foods dispensed from vending machines could attract insects and 

rodents, a self-closing door is required as a barrier to their entrance.

4-204.15 Bearings and Gear Boxes, Leakproof.

It is not unusual for food equipment to contain bearings and gears. Lubricants 

necessary for the operation of these types of equipment could contaminate food or 

food-contact surfaces if the equipment is not properly designed and constructed.

4-204.16 Beverage Tubing, Separation.

Beverage tubing and coldplate cooling devices may result in contamination if they are 

installed in direct contact with stored ice. Beverage tubing installed in contact with ice 

may result in condensate and drippage contaminating the ice as the condensate moves 

down the beverage tubing and ends up in the ice.

The presence of beverage tubing and/or coldplate cooling devices also presents 

cleaning problems. It may be difficult to adequately clean the ice bin if they are present. 

Because of the high moisture environment, mold and algae may form on the surface of 

the ice bins and any tubing or equipment stored in the bins. 
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4-204.17 Ice Units, Separation of Drains.

Liquid waste drain lines passing through ice machines and storage bins present a risk of 

contamination due to potential leakage of the waste lines and the possibility that 

contaminants will gain access to the ice through condensate migrating along the 

exterior of the lines. 

Liquid drain lines passing through the ice bin are, themselves, difficult to clean and 

create other areas that are difficult to clean where they enter the unit as well as where 

they abut other surfaces. The potential for mold and algal growth in this area is very 

likely due to the high moisture environment. Molds and algae that form on the drain 

lines are difficult to remove and present a risk of contamination to the ice stored in the 

bin.

4-204.18 Condenser Unit, Separation. 

A dust-proof barrier between a condenser and food storage areas of equipment 

protects food and food-contact areas from contamination by dust that is accumulated 

and blown about as a result of the condenser's operation. 

4-204.19 Can Openers on Vending Machines.

Since the cutting or piercing surfaces of a can opener directly contact food in the 

container being opened, these surfaces must be protected from contamination.

4-204.110 Molluscan Shellfish Tanks.

Shellfish are filter feeders allowing concentration of pathogenic microorganisms that 

may be present in the water. Due to the number of shellfish and the limited volume of 

water used, display tanks may allow concentration of pathogenic viruses and bacteria. 

Since many people eat shellfish either raw or lightly cooked, the potential for increased 

levels of pathogenic microorganisms in shellfish held in display tanks is of concern. If 

shellfish stored in molluscan shellfish tanks are offered for consumption, certain 

safeguards must be in place as specified in a detailed HACCP plan that is approved by 

the regulatory authority. Opportunities for contamination must be controlled or 

eliminated. Procedures must emphasize strict monitoring of the water quality of the tank 

including the filtering and disinfection system. 

4-204.111 Vending Machines, Automatic Shutoff.

Failure to store time/temperature control for safety food at safe temperatures in a 

vending machine could result in the growth of pathogenic microorganisms that may 

result in foodborne illness. The presence of an automatic control that prevents the 

vending of food if the temperature of the unit exceeds Code requirements precludes the 

vending of foods that may not be safe. 

It is possible and indeed very likely that the temperature of the storage area of a 

vending machine may exceed Code requirements during the stocking and servicing of 
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the machine. The automatic shut off, commonly referred to as the "public health 

control,” provides a limited amount of time that the ambient temperature of a machine 

may exceed Code requirements. Strict adherence to the time requirements can limit the 

growth of pathogenic microorganisms.

4-204.112 Temperature Measuring Devices.

The placement of the temperature measuring device is important. If the device is placed 

in the coldest location in the storage unit, it may not be representative of the 

temperature of the unit. Food could be stored in areas of the unit that exceed Code 

requirements. Therefore, the temperature measuring device must be placed in a 

location that is representative of the actual storage temperature of the unit to ensure 

that all time/temperature control for safety foods are stored at least at the minimum 

temperature required in Chapter 3. 

Installing an air thermometer in some open display refrigerators can be difficult without 

physically impairing the usability of the case and interfering with cleaning and sanitation. 

Use of a temperature monitoring system that uses probe-like sensors that are placed in 

material resembling the density of food is an acceptable alternative. Thus, the direct 

temperature of the substitute product is measured by use of this product mimicking 

method. 

A permanent temperature measuring device is required in any unit storing 

time/temperature control for safety food because of the potential growth of pathogenic 

microorganisms should the temperature of the unit exceed Code requirements. In order 

to facilitate routine monitoring of the unit, the device must be clearly visible.

The exception to requiring a temperature measuring device for the types of equipment 

listed is primarily due to equipment design and function. It would be difficult and 

impractical to permanently mount a temperature measuring device on the equipment 

listed. The futility of attempting to measure the temperature of unconfined air such as 

with heat lamps and, in some cases, the brief period of time the equipment is used for a 

given food negate the usefulness of ambient temperature monitoring at that point. In 

such cases, it would be more practical and accurate to measure the internal 

temperature of the food. 

The importance of maintaining time/temperature control for safety foods at the specified 

temperatures requires that temperature measuring devices be easily readable. The 

inability to accurately read a thermometer could result in food being held at unsafe 

temperatures.

Temperature measuring devices must be appropriately scaled per Code requirements 

to ensure accurate readings.

The required incremental gradations are more precise for food measuring devices than 

for those used to measure ambient temperature because of the significance at a given 

point in time, i.e., the potential for pathogenic growth, versus the unit's temperature. 

The food temperature will not necessarily match the ambient temperature of the storage 
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unit; it will depend on many variables including the temperature of the food when it is 

placed in the unit, the temperature at which the unit is maintained, and the length of 

time the food is stored in the unit. 

4-204.113 Warewashing Machine, Data Plate Operating Specifications. 

The data plate provides the operator with the fundamental information needed to ensure 

that the machine is effectively washing, rinsing, and sanitizing equipment and utensils. 

The warewashing machine has been tested, and the information on the data plate 

represents the parameters that ensure effective operation and sanitization and that 

need to be monitored. 

4-204.114 Warewashing Machines, Internal Baffles.

The presence of baffles or curtains separating the various operational cycles of a 

warewashing machine such as washing, rinsing, and sanitizing are designed to reduce 

the possibility that solutions from one cycle may contaminate solutions in another. The 

baffles or curtains also prevent food debris from being splashed onto the surface of 

equipment that has moved to another cycle in the procedure.

4-204.115 Warewashing Machines, Temperature Measuring Devices.

The requirement for the presence of a temperature measuring device in each tank of 

the warewashing machine is based on the importance of temperature in the sanitization 

step. In hot water machines, it is critical that minimum temperatures be met at the 

various cycles so that the cumulative effect of successively rising temperatures causes 

the surface of the item being washed to reach the required temperature for sanitization. 

When chemical sanitizers are used, specific minimum temperatures must be met 

because the effectiveness of chemical sanitizers is directly affected by the temperature 

of the solution. 

4-204.116 Manual Warewashing Equipment, Heaters and Baskets.

Hot water sanitization is accomplished in water of not less than 77oC (170oF) and an 

integral heating device is necessary to ensure that the minimum temperature is 

reached.

The rack or basket is required in order to safely handle the equipment and utensils 

being washed and to ensure immersion. Water at this temperature could result in 

severe burns to employees operating the equipment. 

4-204.117 Warewashing Machines, Automatic Dispensing of Detergents 

and Sanitizers. 

The presence of adequate detergents and sanitizers is necessary to effect clean and 

sanitized utensils and equipment. The automatic dispensing of these chemical agents, 

plus a method such as a flow indicator, flashing light, buzzer, or visible open air delivery 

system that alerts the operator that the chemicals are no longer being dispensed, 

ensures that utensils are subjected to an efficacious cleaning and sanitizing regimen. 
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4-204.118 Warewashing Machines, Flow Pressure Device.

Flow pressure is a very important factor impacting the efficacy of sanitization in 

machines that use fresh hot water at line-pressure as a final sanitization rinse. (See 

discussion in Public Health Reason for section 4-203.13.) It is important that the 

operator be able to monitor, and the food inspector be able to check, final sanitization 

rinse pressure as well as machine water temperatures. ANSI/NSF Standard #3, a 

national voluntary consensus standard for Commercial Spray-Type Dishwashing 

Machines, specifies that a pressure gauge or similar device be provided on this type 

machine and such devices are shipped with machines by the manufacturer. Flow 

pressure devices installed on the upstream side of the control (solenoid) valve are 

subject to damage and failure due to the water hammer effect caused throughout the 

dishwashing period each time the control valve closes. The IPS valve provides a ready 

means for checking line-pressure with an alternative pressure measuring device. A flow 

pressure device is not required on machines that use only a pumped or recirculated 

sanitizing rinse since an appropriate pressure is ensured by a pump and is not 

dependent upon line-pressure. 

4-204.121 Vending Machines, Liquid Waste Products.

The presence of internal waste containers allows for the collection of liquids that spill 

within the vending machine. Absence of a waste container or, where required, a shutoff 

valve which controls the incoming liquids could result in wastes spilling within the 

machine, causing a condition that attracts insects and rodents and compounds cleaning 

and maintenance problems. 

4-204.122 Case Lot Handling Equipment, Movability.

Proper design of case lot handling equipment facilitates moving case lots for cleaning 

and for surveillance of insect or rodent activity.

4-204.123 Vending Machine Doors and Openings.

The objective of this requirement is to provide a barrier against the entrance into 

vending machines of insects, rodents, and dust. The maximum size of the openings 

deters the entrance of common pests. 

Acceptability

4-205.10 Food Equipment, Certification and Classification.

Commercial food equipment standards that are designated as American National 

Standards have been developed by a Standards Developing Organization (SDO) that is 

accredited by the American National Standards Institute (ANSI). Accreditation by ANSI 

signifies that the procedures used by the SDO in the development of American National 

Standards meet the Institute’s essential requirements for openness, balance, 

consensus and due process.
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Refer to the following link (https://www.fda.gov/media/133482/download) for a listing of 

the American National Standards that address the sanitary materials, design and 

construction of commercial food equipment commonly used in retail and foodservice 

establishments.

Under ANSI document CA-1 ANSI Policy and Criteria for Accreditation of Certification 

Programs, it has been stipulated that: 

"For food equipment programs, standards that establish sanitation requirements shall 

be specified government standards or standards that have been ratified by a public 

health approval step. ANSI shall verify that this requirement has been met by 

communicating with appropriate standards developing organizations and governmental 

public health bodies." 

The term certified is used when an item of food equipment has been evaluated against 

an organization's own standard. The term classified is used when one organization 

evaluates an item of food equipment against a standard developed by another 

organization. 

Equipment

4-301.11 Cooling, Heating, and Holding Capacities.

The ability of equipment to cool, heat, and maintain time/temperature control for safety 

foods at Code-required temperatures is critical to food safety. Improper holding and 

cooking temperatures continue to be major contributing factors to foodborne illness. 

Therefore, it is very important to have adequate hot or cold holding equipment with 

enough capacity to meet the heating and cooling demands of the operation. 

4-301.12 Manual Warewashing, Sink Compartment Requirements.

The 3 compartment requirement allows for proper execution of the 3-step manual 

warewashing procedure. If properly used, the 3 compartments reduce the chance of 

contaminating the sanitizing water and therefore diluting the strength and efficacy of the 

chemical sanitizer that may be used.

Alternative manual warewashing equipment, allowed under certain circumstances and 

conditions, must provide for accomplishment of the same 3 steps:

1. Application of cleaners and the removal of soil;

2. Removal of any abrasive and removal or dilution of cleaning chemicals; and

3. Sanitization.

Refer also to the public health reason for § 4-603.16.

4-301.13 Drainboards. 
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Drainboards or equivalent equipment are necessary to separate soiled and cleaned 

items from each other and from the food preparation area in order to preclude 

contamination of cleaned items and of food.

Drainboards allow for the control of water running off equipment and utensils that have 

been washed and also allow the operator to properly store washed equipment and 

utensils while they air-dry. 

4-301.14 Ventilation Hood Systems, Adequacy.

If a ventilation system is inadequate, grease and condensate may build up on the floors, 

walls and ceilings of the food establishment, causing an insanitary condition and 

possible deterioration of the surfaces of walls and ceilings. The accumulation of grease 

and condensate may contaminate food and food-contact surfaces as well as present a 

possible fire hazard. 

Refer also to the public health reason for § 4-204.11.

4-301.15 Clothes Washers and Dryers.

To protect food, soiled work clothes or linens must be efficiently laundered. The only 

practical way of efficiently laundering work clothes on the premises is with the use of a 

mechanical washer and dryer.

Refer also to the public health reason for § 4-401.11.

Utensils, temperature measuring devices, and testing devices

4-302.11 Utensils, Consumer Self-Service.

Appropriate serving utensils provided at each container will, among other things, reduce 

the likelihood of food tasting, use of fingers to serve food, use of fingers to remove the 

remains of one food on the utensil so that it may be used for another, use of soiled 

tableware to transfer food, and cross contamination between foods, including a raw food 

to a cooked time/temperature control for safety food. 

4-302.12 Food Temperature Measuring Devices.

The presence and accessibility of food temperature measuring devices is critical to the 

effective monitoring of food temperatures. Proper use of such devices provides the 

operator or person in charge with important information with which to determine if 

temperatures should be adjusted or if foods should be discarded. 

When determining the temperature of thin foods, those having a thickness less than 

13 mm (1/2 inch), it is particularly important to use a temperature sensing probe 

designed for that purpose. Bimetal, bayonet style thermometers are not suitable for 

accurately measuring the temperature of thin foods such as hamburger patties because 

of the large diameter of the probe and the inability to accurately sense the temperature 

at the tip of the probe. However, temperature measurements in thin foods can be 
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accurately determined using a small-diameter probe 1.5 mm (0.059 inch), or less, 

connected to a device such as thermocouple thermometer. 

4-302.13 Temperature Measuring Devices, Manual Warewashing.

Water temperature is critical to sanitization in warewashing operations. This is 

particularly true if the sanitizer being used is hot water. The effectiveness of cleaners 

and chemical sanitizers is also determined by the temperature of the water used. A 

temperature measuring device is essential to monitor manual warewashing and ensure 

sanitization. 

Effective mechanical hot water sanitization occurs when the surface temperatures of 

utensils passing through the warewashing machine meet or exceed the required

71°C(160°F). Parameters such as water temperature, rinse pressure, and time 

determine whether the appropriate surface temperature is achieved. Although the Food 

Code requires integral temperature measuring devices and a pressure gauge for hot 

water mechanical warewashers, the measurements displayed by these devices may not 

always be sufficient to determine that the surface temperatures of utensils are reaching 

71°C(160°F). The regular use of irreversible registering temperature indicators provides 

a simple method to verify that the hot water mechanical sanitizing operation is effective 

in achieving a utensil surface temperature of 71oC (160oF).

4-302.14 Sanitizing Solutions, Testing Devices.

Testing devices to measure the concentration of sanitizing solutions are required for 

2 reasons:

1. The use of chemical sanitizers requires minimum concentrations of the 

sanitizer during the final rinse step to ensure sanitization; and 

2. Too much sanitizer in the final rinse water could be toxic. 

4-303.11 Cleaning Agents and Sanitizers, Availability

If the appropriate cleaning agents and sanitizers are not on hand at all times they may 

not be available when needed to clean and sanitize equipment and utensils. It is also 

important that the cleaning agents and sanitizers be on hand, even at times where 

warewashing may not be in progress, so that their suitability can be verified by the 

regulatory authority and, if needed, by personnel who are responsible for servicing the 

equipment.

Location

4-401.11 Equipment, Clothes Washers and Dryers, and Storage 

Cabinets, Contamination Prevention.

Food equipment and the food that contacts the equipment must be protected from 

sources of overhead contamination such as leaking or ruptured water or sewer pipes, 
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dripping condensate, and falling objects. When equipment is installed, it must be 

situated with consideration of the potential for contamination from such overhead 

sources. 

If a clothes washer and dryer are installed adjacent to exposed food, clean equipment, 

utensils, linens, and unwrapped single-service and single-use articles, it could result in 

those items becoming contaminated from soiled laundry. The reverse is also true, i.e., 

items being laundered could become contaminated from the surrounding area if the 

washer and dryer are not properly located.

Installation

4-402.11 Fixed Equipment, Spacing or Sealing.

This section is designed to ensure that fixed equipment is installed in a way that:

1. Allows accessibility for cleaning on all sides, above, and underneath the units 

or minimizes the need for cleaning due to closely abutted surfaces; 

2. Ensures that equipment that is subject to moisture is sealed;

3. Prevents the harborage of insects and rodents; and 

4. Provides accessibility for the monitoring of pests. 

4-402.12 Fixed Equipment, Elevation or Sealing.

The inability to adequately or effectively clean areas under equipment could create a 

situation that may attract insects and rodents and accumulate pathogenic 

microorganisms that are transmissible through food. 

The effectiveness of cleaning is directly affected by the ability to access all areas to 

clean fixed equipment. It may be necessary to elevate the equipment. When elevating 

equipment is not feasible or prohibitively expensive, sealing to prevent contamination is 

required. 

The economic impact of the requirement to elevate display units in retail food stores, 

coupled with the fact that the design, weight, and size of such units are not conducive to 

casters or legs, led to the exception for certain units located in consumer shopping 

areas, provided the floor under the units is kept clean. This exception for retail food 

store display equipment including shelving, refrigeration, and freezer units in the 

consumer shopping areas requires a rigorous cleaning schedule. 

Equipment

4-501.11 Good Repair and Proper Adjustment.

Proper maintenance of equipment to manufacturer specifications helps ensure that it 

will continue to operate as designed. Failure to properly maintain equipment could lead 

to violations of the associated requirements of the Code that place the health of the 

consumer at risk. For example, refrigeration units in disrepair may no longer be capable 
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of properly cooling or holding time/temperature control for safety foods at safe 

temperatures. 

The cutting or piercing parts of can openers may accumulate metal fragments that could 

lead to food containing foreign objects and, possibly, result in consumer injury.

Adequate cleaning and sanitization of dishes and utensils using a warewashing 

machine is directly dependent on the exposure time during the wash, rinse, and

sanitizing cycles. Failure to meet manufacturer and Code requirements for cycle times 

could result in failure to clean and sanitize. For example, high temperature machines 

depend on the buildup of heat on the surface of dishes to accomplish sanitization. If the 

exposure time during any of the cycles is not met, the surface of the items may not 

reach the time-temperature parameter required for sanitization. Contact time is also 

important in warewashing machines that use a chemical sanitizer since the sanitizer 

must contact the items long enough for sanitization to occur. In addition, a chemical 

sanitizer will not sanitize a dirty dish; therefore, the cycle times during the wash and 

rinse phases are critical to sanitization.

4-501.12 Cutting Surfaces.

Cutting surfaces such as cutting boards and blocks that become scratched and scored 

may be difficult to clean and sanitize. As a result, pathogenic microorganisms 

transmissible through food may build up or accumulate. These microorganisms may be 

transferred to foods that are prepared on such surfaces. 

4-501.13 Microwave Ovens. 

Failure of microwave ovens to meet the CFR standards could result in human exposure 

to radiation leakage, resulting in possible medical problems to consumers and 

employees using the machines. 

4-501.14 Warewashing Equipment, Cleaning Frequency.

During operation, warewashing equipment is subject to the accumulation of food wastes 

and other soils or sources of contamination. In order to ensure the proper cleaning and 

sanitization of equipment and utensils, it is necessary to clean the surface of 

warewashing equipment before use and periodically throughout the day. 

4-501.15 Warewashing Machines, Manufacturers' 

Operating Instructions.

To ensure properly cleaned and sanitized equipment and utensils, warewashing 

machines must be operated properly. The manufacturer affixes a data plate to the 

machine providing vital, detailed instructions about the proper operation of the machine 

including wash, rinse, and sanitizing cycle times and temperatures which must be 

achieved.
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4-501.16 Warewashing Sinks, Use Limitation.

If the wash sink is used for functions other than warewashing, such as washing wiping 

cloths or washing and thawing foods, contamination of equipment and utensils could 

occur. 

4-501.17 Warewashing Equipment, Cleaning Agents.

Failure to use detergents or cleaners in accordance with the manufacturer's label 

instructions could create safety concerns for the employee and consumer. For example, 

employees could suffer chemical burns, and chemical residues could find their way into 

food if detergents or cleaners are used carelessly. 

Equipment or utensils may not be cleaned if inappropriate or insufficient amounts of 

cleaners or detergents are used.

4-501.18 Warewashing Equipment, Clean Solutions.

Failure to maintain clean wash, rinse, and sanitizing solutions adversely affects the 

warewashing operation. Equipment and utensils may not be sanitized, resulting in 

subsequent contamination of food.

4-501.19 Manual Warewashing Equipment, Wash Solution Temperature.

The wash solution temperature required in the Code is essential for removing organic 

matter. If the temperature is below 110oF, the performance of the detergent may be 

adversely affected, e.g., animal fats that may be present on the dirty dishes would not 

be dissolved.

4-501.110 Mechanical Warewashing Equipment, Wash 

Solution Temperature.

The wash solution temperature in mechanical warewashing equipment is critical to 

proper operation. The chemicals used may not adequately perform their function if the 

temperature is too low. Therefore, the manufacturer's instructions must be followed. The 

temperatures vary according to the specific equipment being used. 

4-501.111 Manual Warewashing Equipment, Hot Water Sanitization 

Temperatures.

If the temperature during the hot water sanitizing step is less than 77oC (171oF), 

sanitization will not be achieved. As a result, pathogenic organisms may survive and be 

subsequently transferred from utensils to food.

4-501.112 Mechanical Warewashing Equipment, Hot Water Sanitization 

Temperatures.
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The temperature of hot water delivered from a warewasher sanitizing rinse manifold 

must be maintained according to the equipment manufacturer’s specifications and 

temperature limits specified in this section to ensure surfaces of multiuse utensils such 

as kitchenware and tableware accumulate enough heat to destroy pathogens that may 

remain on such surfaces after cleaning. 

The surface temperature must reach at least 71oC (160oF) as measured by an 

irreversible registering temperature measuring device to affect sanitization. When the 

sanitizing rinse temperature exceeds 90oC (194oF) at the manifold, the water becomes 

volatile and begins to vaporize reducing its ability to convey sufficient heat to utensil 

surfaces. The lower temperature limits of 74oC (165oF) for a stationary rack, single 

temperature machine, and 82oC (180oF) for other machines are based on the sanitizing 

rinse contact time required to achieve the 71oC (160oF) utensil surface temperature.

4-501.113 Mechanical Warewashing Equipment, Sanitization Pressure.

If the flow pressure of the final sanitizing rinse is less than that required, dispersion of 

the sanitizing solution may be inadequate to reach all surfaces of equipment or utensils. 

4-501.114 Manual and Mechanical Warewashing Equipment, Chemical 

Sanitization - Temperature, pH, Concentration, and Hardness.

With the passage of the Food Quality Protection Act of 1996 and the related 

Antimicrobial Regulation Technical Correction Act of 1998, Federal regulatory 

responsibility for chemical hard surface sanitizers was moved from FDA 

(CFSAN/OFAS) to EPA (Office of Pesticides Programs, Antimicrobial Division). As a 

result, the relevant Federal regulation has moved from 21 CFR 178.1010 to 40 CFR 

180.940. The Food Code contains provisions that were not captured in either 21 CFR 

178.1010 or 40 CFR 180.940, such as pH, temperature, and water hardness. There is 

need to retain these provisions in the Code.

The effectiveness of chemical sanitizers can be directly affected by the temperature, 

pH, concentration of the sanitizer solution used, and hardness of the water. Provisions 

for pH, temperature, and water hardness in section 4-501.114 have been validated to 

achieve sanitization; however, these parameters are not always included on EPAregistered labels. Therefore, it is critical to sanitization that the sanitizers are used 

consistently with the EPA-registered label, and if pH, temperature, and water hardness 

(for quat) are not included on the label, that the solutions meet the standards required in 

the Code. 

With respect to chemical sanitization, section 4-501.114 addresses the proper use 

conditions for the sanitizing solution, i.e., chemical concentration range, pH, and 

temperature minimum levels and, with respect to quaternary ammonium compounds 

(quats), the maximum hardness level. If these parameters are not as specified in the 

Code or on the EPA-registered label, then this provision is violated. Paragraph 4-

501.114(E) provides for the use of other chemical sanitizers besides chlorine, iodine, 

and quaternary ammonium compounds. This section is not intended to limit formulation 

of food contact sanitizers to only chlorine, iodine, or quaternary ammonium compounds. 
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Alternative active ingredients are permitted as long as they are listed in 40 CFR 180.940 

and used in accordance with the EPA-registered label use instructions for food contact 

surface sanitizers. 

By contrast, paragraph 4-703.11(C) addresses contact time in seconds. For chemical 

sanitization, this paragraph is only violated when the specified contact time is not met.

Section 7-204.11 addresses whether or not the chemical agent being applied as a 

sanitizer is approved and listed for that use under 40 CFR 180.940.

EPA sanitizer registration assesses compliance with 40 CFR 180.940, therefore if the 

product is used at the appropriate concentration for the application on the EPAregistered label, it is not necessary to consult 40 CFR 180.940 for further compliance 

verification. If a sanitarian determined that a solution exceeded the concentration for the 

application on the EPA-registered label or is used for an application that is not on the 

EPA-registered label, section 7-204.11 would be violated. 

To summarize, a sanitizing solution that is too weak would be a violation of section 4-

501.114. A solution that is too strong would be a violation of section 7-204.11. Section 

7-202.12 would not be violated due to the existence of section 7-204.11 that specifically 

addresses the use chemical sanitizers.

A variety of hard food contact surface sanitizers such as sodium hypochlorite or 

hypochlorous acid, can be generated on-site by technologies known as electrolyzed 

water, electro chemically activated water, and electro activated water in pesticide 

generating devices. Paragraph 4-501.114(F) addresses the efficacy and use of these 

on-site generated solutions and Section 4-703.11 requires that the conditions of use 

yields sanitization as defined in paragraph 1-201.10(B), i.e., a 5 log (99.999%) 

reduction. 

Because EPA does not require registration of solutions generated and used on-site, the 

user of the equipment should look to the device manufacturer for data to validate the 

efficacy of the solution produced by the device as well as the conditions for use of the 

solution (e.g., concentration, temperature, contact time, pH, and other applicable 

factors). These data should be available on-site in the food establishment. 

Any data used to validate efficacy of on-site generated sanitizer solutions should include 

validation testing that includes all factors that could impact the efficacy of the sanitizer 

solution, including water hardness, pH, temperature, and a time element because 

efficacy can reduce with time. The report should also clearly identify the minimum 

acceptable concentration of active ingredient required for that product to pass the test. 

This testing is best performed under Good Laboratory Practices. See the EPA web site 

at http://www.epa.gov/compliance/monitoring/programs/fifra/glp.html. According to the 

web site, “EPA’s Good Laboratory Practice Standards (GLPS) compliance monitoring 

program ensures the quality and integrity of test data submitted to the Agency in 

support of a pesticide product registration under FIFRA section 5 of the Toxic 

Substances Control Act (TSCA), and pursuant to testing consent agreements and test 

rules issued under section 4 of TSCA.”
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Verifying the adequacy of chlorine-based solutions can be accomplished on an on-going 

basis by confirming that the concentration, temperature, and pH of the sanitizing 

solutions comply with paragraph 4-501.114 (A) using acceptable test methods and 

equipment. 

The manufacturer should provide methods (e.g., test strips, kits, etc.) to verify that the 

equipment consistently generates a solution on-site at the necessary concentration to 

achieve sanitization. 

Devices can be used for years to produce chemicals intended for the washing of fruits 

and vegetables, (e.g., hypochlorous acid, ozone, and chlorine dioxide). Other devices 

that are capable of producing hard food contact surface cleaning and sanitizing 

solutions on-site (e.g., chlorine, hypochlorous acid that are generated by processes 

known as electrolyzed water, electro chemically activated water, and electro activated 

water). 

A device used to generate hard food contact surface sanitizers on-site is considered a 

pesticide device. The Environmental Protection Agency (EPA) defines a device in

40 CFR 152.500, Requirements for devices, as “(a) A device is defined as any 

instrument or contrivance (other than a firearm) intended for trapping, destroying, 

repelling, or mitigating any pest or any other form of plant or animal life (other than man 

and other than a bacterium, virus, or other microorganism on or in living man or living 

animals) but not including equipment used for the application of pesticides (such as 

tamper-resistant bait boxes for rodenticides) when sold separately therefrom.”

The EPA does not require the registration of pesticide devices; however, these devices 

must be produced in a registered establishment. The data plate should list the 

establishment number. Additionally, device label requirements are established by 

section 2(q)(1) and section 12 of Federal Insecticide, Fungicide, and Rodenticide Act 

(FIFRA), as well as 40 CFR 152.500 Requirements for Devices and 156.10 Labeling 

Requirements. No statement that is false or misleading can appear in a device's 

labeling. Statements that are subject to this regulation include, but are not limited to: 

The name, brand, or trademark under which the product is sold ·

An ingredient statement 

Statements concerning effectiveness of the product 

Hazard and precautionary statements for human and domestic animals

Environmental and exposure hazards

The directions for use

Maintaining and cleaning devices used for the on-site generation of sanitizing solutions 

in accordance with manufacturer’s specifications will help to ensure that they continue 

to generate the sanitizer chemicals in the form and concentration for which their efficacy 

was assessed.

4-501.115 Manual Warewashing Equipment, Chemical 

Sanitization Using Detergent-Sanitizers.
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Some chemical sanitizers are not compatible with detergents when a 2 compartment 

operation is used. When using a sanitizer that is different from the detergent-sanitizer of 

the wash compartment, the sanitizer may be inhibited by carry-over, resulting in 

inadequate sanitization. 

4-501.116 Warewashing Equipment, Determining Chemical Sanitizer 

Concentration.

The effectiveness of chemical sanitizers is determined primarily by the concentration 

and pH of the sanitizer solution. Therefore, a test kit is necessary to accurately 

determine the concentration of the chemical sanitizer solution.

Utensils and temperature and pressure measuring devices

4-502.11 Good Repair and Calibration.

A utensil or food temperature measuring device can act as a source of contamination to 

the food it contacts if it is not maintained in good repair. Also, if temperature or pressure 

measuring devices are not maintained in good repair, the accuracy of the readings is 

questionable. Consequently, a temperature problem may not be detected, or 

conversely, a corrective action may be needlessly taken.

4-502.12 Single-Service and Single-Use Articles, Required Use.

In situations in which the reuse of multiuse items could result in foodborne illness to 

consumers, single-service and single-use articles must be used to ensure safety.

4-502.13 Single-Service and Single-Use Articles, Use Limitation.

Articles that are not constructed of multiuse materials may not be reused as they are 

unable to withstand the rigors of multiple uses, including the ability to be subjected to 

repeated washing, rinsing, and sanitizing.

4-502.14 Shells, Use Limitation.

The reuse of mollusk and crustacean shells as multiuse utensils is not allowed in food 

establishments. This prohibition does not apply to the removal of the oyster or other 

species from the shell for preparation, then returning the same animal to the same shell 

for service. 

The shell itself may be potentially unsafe for use as a food utensil because of residues 

from natural and environmental contamination occurring after the mollusk or crustacean 

is removed. In addition, natural shells are not durable or easily cleanable as specified 

under section 4-502.13. When mollusk or crustacean shells (from commercial sources) 

are re-used by filling them with shucked shellfish, the food is considered misleading and 

not honestly presented. 
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Objective

4-601.11 Equipment, Food-Contact Surfaces, Nonfood-Contact 

Surfaces, and Utensils.

The objective of cleaning focuses on the need to remove organic matter from foodcontact surfaces so that sanitization can occur and to remove soil from nonfood contact 

surfaces so that pathogenic microorganisms will not be allowed to accumulate and 

insects and rodents will not be attracted.

Frequency

4-602.11 Equipment Food-Contact Surfaces and Utensils.

Microorganisms may be transmitted from a food to other foods by utensils, cutting 

boards, thermometers, or other food-contact surfaces. Food-contact surfaces and 

equipment used for time/temperature control for safety foods should be cleaned as 

needed throughout the day but must be cleaned no less than every 4 hours to prevent 

the growth of microorganisms on those surfaces. 

Refrigeration temperatures slow down the generation time of bacterial pathogens, 

making it unnecessary to clean every four hours. However, the time period between 

cleaning equipment and utensils may not exceed 24 hours. A time-temperature chart is 

provided in subparagraph 4-602.11(D)(2) to accommodate operations that use 

equipment and utensils in a refrigerated room or area that maintains a temperature 

between 41oF or less and 55oF. 

Surfaces of utensils and equipment contacting food that is not time/temperature control 

for safety food such as iced tea dispensers, carbonated beverage dispenser nozzles, 

beverage dispensing circuits or lines, water vending equipment, coffee bean grinders, 

ice makers, and ice bins must be cleaned on a routine basis to prevent the development 

of slime, mold, or soil residues that may contribute to an accumulation of 

microorganisms. Some equipment manufacturers and industry associations, e.g., within 

the tea industry, develop guidelines for regular cleaning and sanitizing of equipment. If 

the manufacturer does not provide cleaning specifications for food-contact surfaces of 

equipment that are not readily visible, the person in charge should develop a cleaning 

regimen that is based on the soil that may accumulate in those particular items of 

equipment. 

Regarding the possible adulteration from one species of meat to another between 

cleaning of food-contact surfaces, USDA/FSIS does not automatically consider species 

adulteration as a health hazard. FSIS stated in an Advance Notice of Proposed 

Rulemaking that species adulteration falls into a gray area between safety and 

economic adulteration (65 FR 14486, March 17, 2000, Other Consumer Protection 

Activities). FSIS will review public comments received on the species adulteration issue 

and further review the scientific literature and risk assessment mechanisms before 

declaring species adulteration a health hazard. Meanwhile, species adulteration is 

generally considered by FSIS as an economic issue. However, investigations by FSIS 
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of species adulteration incidents may include a determination regarding the impact of 

species adulteration as a health hazard on a case-by-case basis. 

The 2012 Conference for Food Protection (CFP) requested that FDA amend §4-602.11 

of the Food Code to require that equipment food contact surfaces and utensils that have 

contacted raw animal foods that are major food allergens be cleaned before use with 

other raw animal foods (Issue 2012-III-024). FDA recognizes that in addition to their 

intended use as ingredients, the unintended presence of major food allergens in foods 

may occur through cross-contact. Cross-contact describes the inadvertent introduction 

of an allergen into a product that would not intentionally contain that allergen as an 

ingredient. While most cross-contact can be avoided through control of the environment 

during food production and preparation, the CFP request only addresses allergen crosscontact from raw animal foods that are major food allergens and therefore, falls short of 

comprehensive allergen cross-contact control for all eight (8) major food allergens. 

Although limited in scope, such a change supports the continued efforts of FDA to work 

in cooperation with the Conference for Food Protection toward control of food allergens 

in retail food establishments. Therefore, §4-602.11 was amended to require that food

contact surfaces of equipment and utensils that have contacted raw animal foods that 

are major food allergens, such as raw fish, must be cleaned and sanitized prior to 

contacting other types of raw animal foods.

Refer also to Annex 4 - Management of Food Safety Principles for Food Allergens as 

Food Safety Hazards.

4-602.12 Cooking and Baking Equipment.

Food-contact surfaces of cooking equipment must be cleaned to prevent encrustations 

that may impede heat transfer necessary to adequately cook food. Encrusted 

equipment may also serve as an insect attractant when not in use. Because of the 

nature of the equipment, it may not be necessary to clean cooking equipment as 

frequently as the equipment specified in § 4-602.11. 

4-602.13 Nonfood-Contact Surfaces.

The presence of food debris or dirt on nonfood contact surfaces may provide a suitable 

environment for the growth of microorganisms which employees may inadvertently 

transfer to food. If these areas are not kept clean, they may also provide harborage for 

insects, rodents, and other pests.

Methods

4-603.11 Dry Cleaning.

Dry cleaning methods are indicated in only a few operations, which are limited to dry 

foods that are not time/temperature control for safety foods. Under some circumstances, 

attempts at wet cleaning may create microbiological concerns.
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4-603.12 Precleaning.

Precleaning of utensils, dishes, and food equipment allows for the removal of grease 

and food debris to facilitate the cleaning action of the detergent. Depending upon the 

condition of the surface to be cleaned, detergent alone may not be sufficient to loosen 

soil for cleaning. Heavily soiled surfaces may need to be presoaked or scrubbed with an 

abrasive. 

4-603.13 Loading of Soiled Items, Warewashing Machines.

Items to be washed in a warewashing machine must receive unobstructed exposure to 

the spray to ensure adequate cleaning. Items which are stacked or trays which are 

heavily loaded with silverware cannot receive complete distribution of detergent, water, 

or sanitizer and cannot be considered to be clean.

4-603.14 Wet Cleaning.

Because of the variety of cleaning agents available and the many different types of soil 

to be removed it is not possible to recommend one cleaning agent to fit all situations. 

Each of the different types of cleaners works best under different conditions (i.e., some 

work best on grease, some work best in warm water, others work best in hot water). 

The specific chemical selected should be compatible with any other chemicals to be 

used in the operation such as a sanitizer or drying agent. 

4-603.15 Washing, Procedures for Alternative Manual Warewashing 

Equipment.

Some pieces of equipment are fixed or too large to be cleaned in a sink. Nonetheless, 

cleaning of such equipment requires the application of cleaners for the removal of soil 

and rinsing for the removal of abrasive and cleaning chemicals, followed by sanitization. 

4-603.16 Rinsing Procedures.

It is important to rinse off detergents, abrasive, and food debris after the wash step to 

avoid diluting or inactivating the sanitizer.

Objective

4-701.10 Food-Contact Surfaces and Utensils. 

Effective sanitization procedures destroy organisms of public health importance that 

may be present on wiping cloths, food equipment, or utensils after cleaning, or which 

have been introduced into the rinse solution. It is important that surfaces be clean 

before being sanitized to allow the sanitizer to achieve its maximum benefit.
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Frequency

4-702.11 Before Use After Cleaning.

Sanitization is accomplished after the warewashing steps of cleaning and rinsing so that 

utensils and food-contact surfaces are sanitized before coming in contact with food and 

before use. 

Methods

4-703.11 Hot Water and Chemical.

Efficacious sanitization depends on warewashing being conducted within certain 

parameters. Time is a parameter applicable to both chemical and hot water sanitization. 

The time hot water or chemicals contact utensils or food-contact surfaces must be 

sufficient to destroy pathogens that may remain on surfaces after cleaning. Other 

parameters, such as rinse pressure, temperature, and chemical concentration are used 

in combination with time to achieve sanitization. 

When surface temperatures of utensils passing through warewashing machines using 

hot water for sanitizing do not reach the required 71oC (160oF), it is important to 

understand the factors affecting the decreased surface temperature. A comparison 

should be made between the machine manufacturer’s operating instructions and the 

machine’s actual wash and rinse temperatures and final rinse pressure. The actual 

temperatures and rinse pressure should be consistent with the machine manufacturer’s 

operating instructions and within limits specified in §§ 4-501.112 and 4-501.113. 

If either the temperature or pressure of the final rinse spray is higher than the specified 

upper limit, spray droplets may disperse and begin to vaporize resulting in less heat 

delivery to utensil surfaces. Temperatures below the specified limit will not convey the 

needed heat to surfaces. Pressures below the specified limit will result in incomplete 

coverage of the heat-conveying sanitizing rinse across utensil surfaces. 

Objective

4-801.11 Clean Linens.

Linens that are not free from food residues and other soiling matter may carry 

pathogenic microorganisms that may cause illness. 

Frequency

4-802.11 Specifications.

Linens, cloth gloves, and cloth napkins are to be laundered between uses to prevent the 

transfer of pathogenic microorganisms between foods or to food-contact surfaces. The 

laundering of wet wiping cloths before being used with a fresh solution of cleanser or 

sanitizer is designed to reduce the microbiological load in the cleanser and sanitizer and 

thereby reduce the possible transfer of microorganisms to food and nonfood-contact 

surfaces.
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Methods

4-803.11 Storage of Soiled Linens.

Soiled linens may directly or indirectly contaminate food. Proper storage will reduce the 

possibility of contamination of food, equipment, utensils, and single-service and singleuse articles.

4-803.12 Mechanical Washing.

Proper laundering of wiping cloths will significantly reduce the possibility that pathogenic 

microorganisms will be transferred to food, equipment, or utensils.

4-803.13 Use of Laundry Facilities.

Washing and drying items used in the operation of the establishment on the premises 

will help prevent the introduction of pathogenic microorganisms into the environment of 

the food establishment.

Drying

4-901.11 Equipment and Utensils, Air-Drying Required.

Items must be allowed to drain and to air-dry before being stacked or stored. Stacking 

wet items such as pans prevents them from drying and may allow an environment 

where microorganisms can begin to grow. Cloth drying of equipment and utensils is 

prohibited to prevent the possible transfer of microorganisms to equipment or utensils. 

4-901.12 Wiping Cloths, Air-Drying Locations.

Cloths that are air-dried must be dried so that they do not drip on food or utensils and so 

that the cloths are not contaminated while air-drying.

Lubricating and reassembling

4-902.11 Food-Contact Surfaces.

Food-contact surfaces must be lubricated in a manner that does not introduce 

contaminants to those surfaces.

4-902.12 Equipment.

Equipment must be reassembled in a way that food-contact surfaces are not 

contaminated. 

Storing

4-903.11 Equipment, Utensils, Linens, and Single-Service and SingleUse Articles.
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Clean equipment and multiuse utensils which have been cleaned and sanitized, 

laundered linens, and single-service and single-use articles can become contaminated 

before their intended use in a variety of ways such as through water leakage, pest 

infestation, or other insanitary condition.

4-903.12 Prohibitions.

The improper storage of clean and sanitized equipment, utensils, laundered linens, and 

single-service and single-use articles may allow contamination before their intended 

use. Contamination can be caused by moisture from absorption, flooding, drippage, or 

splash. It can also be caused by food debris, toxic materials, litter, dust, and other 

materials. The contamination is often related to unhygienic employee practices, 

unacceptable high-risk storage locations, or improper construction of storage facilities.

Preventing contamination

4-904.11 Kitchenware and Tableware.

4-904.12 Soiled and Clean Tableware.

4-904.13 Preset Tableware. 

The presentation or setting of single-service and single-use articles and cleaned and 

sanitized utensils shall be done in a manner designed to prevent the contamination of 

food- and lip-contact surfaces. 

4-904.14 Rinsing Equipment and Utensils after Cleaning and Sanitizing. 

The rinsing of cleaned and sanitized utensils and equipment in a manner that may 

contaminate the surfaces before they are used, such as running them under a faucet or 

by dipping them in a vessel of water, is prohibited. The application of a post-sanitizing 

rinse is restricted to warewashing machines because there will be little opportunity for 

contamination of the potable water rinse if applied within the confines of a compliant 

warewashing machine. Provided the sanitization is achieved before the rinse is applied 

and as long as any chemical sanitizers are used in accordance with an EPA-registered 

label, the sanitary state of utensils and equipment should not be altered by applying a 

potable water rinse after the required final sanitizing rinse within a warewashing 

machine. 
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Chapter 5. Water, Plumbing, and Waste

Source

5-101.11 Approved System.

Water, unless it comes from a safe supply, may serve as a source of contamination for 

food, equipment, utensils, and hands. The major concern is that water may become a 

vehicle for transmission of disease organisms. Water can also become contaminated 

with natural or man-made chemicals. Therefore, for the protection of consumers and 

employees, water must be obtained from a source regulated by law and must be used, 

transported, and dispensed in a sanitary manner.

5-101.12 System Flushing and Disinfection.

During construction, repair, or modification, water systems may become contaminated 

with microbes from soil because pipes are installed underground or by chemicals 

resulting from soldering and welding. Floods and other incidents may also cause water 

to become contaminated. Chemical contaminants such as oils may also be present on 

or in the components of the system. To render the water safe, the system must be 

properly flushed and disinfected before being placed into service. 

5-101.13 Bottled Drinking Water.

Bottled water is obtained from a public water system or from a private source such as a 

spring or well. Either means of production must be controlled by public health law to 

protect the consumer from contaminated water. 

Quality 

5-102.11 Standards.

Bacteriological and chemical standards have been developed for public drinking water 

supplies to protect public health. All drinking water supplies must meet standards 

required by law. 

5-102.12 Nondrinking Water.

Food establishments may use nondrinking water for purposes such as air-conditioning 

or fire protection. Nondrinking water is not monitored for bacteriological and chemical 

quality or safety as is drinking water. Consequently, certain safety precautions must be 

observed to prevent the contamination of food, drinking water, or food-contact surfaces 

by nondrinking water. Identifying the piping designated as nondrinking waterlines and 

inspection for cross connections are examples of safety precautions.

Irrigation water used in the cultivation of fresh produce, e.g. herb gardens or other 

onsite gardens, is another example of nondrinking water. Whenever water comes into 

contact with fresh produce, its quality dictates the potential for pathogen contamination. 

Water has the potential to be a direct source of contamination and vehicle for spreading 
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Annex 3 - 184

contamination. Research has shown that irrigation water can increase the frequency of 

pathogen contamination of harvested produce, and may contain or convey pathogens, 

such as Salmonella spp. Where used, irrigation water should be adequate and 

approved for its intended use in accordance with Good Agricultural Practices (GAPs) 

that minimize the potential for contaminated water to contact the edible portion of the 

crop. FDA’s “Guide to Minimize Microbial Food Safety Hazards for Fresh-cut Fruit and 

Vegetables” provides useful information about GAPs and safely growing, harvesting, 

washing, sorting, packing and distributing produce. It is available at:

http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformati

on/ProducePlantProducts/ucm064458.htm. 

5-102.13 Sampling. 

Wells and other types of individual water supplies may become contaminated through 

faulty equipment or environmental contamination of ground water. Periodic sampling is 

required by law to monitor the safety of the water and to detect any change in quality.

The controlling agency must be able to ascertain that this sampling program is active 

and that the safety of the water is in conformance with the appropriate standards. 

Laboratory results are only as accurate as the sample submitted. Care must be taken 

not to contaminate samples. Proper sample collection and timely transportation to the 

laboratory are necessary to ensure the safety of drinking water used in the 

establishment. 

5-102.14 Sample Report. 

The most recent water sampling report must be kept on file to document a safe water 

supply.

Quantity and availability

5-103.11 Capacity.

Availability of sufficient water is a basic requirement for proper sanitation within a food 

establishment. An insufficient supply of safe water will prevent the proper cleaning of 

items such as equipment and utensils and of food employees' hands. 

Hot water required for washing items such as equipment and utensils and employees' 

hands, must be available in sufficient quantities to meet demand during peak water 

usage periods. Booster heaters for warewashers that use hot water for sanitizing are 

designed to raise the temperature of hot water to a level that ensures sanitization. If the 

volume of water reaching the booster heater is not sufficient or hot enough, the required 

temperature for sanitization can not be reached. 

Manual washing of food equipment and utensils is most effective when hot water is 

used. Unless utensils are clean to sight and touch, they cannot be effectively sanitized.

5-103.12 Pressure. 
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Inadequate water pressure could lead to situations that place the public health at risk. 

For example, inadequate pressure could result in improper handwashing or equipment 

operation. Sufficient water pressure ensures that equipment such as mechanical 

warewashers operate according to manufacturer's specifications. 

Distribution, delivery, and retention

5-104.11 System.

Inadequate water systems may serve as vehicles for contamination of food or foodcontact surfaces. This requirement is intended to ensure that sufficient volumes of water 

are provided from supplies shown to be safe, through a distribution system which is 

protected. 

5-104.12 Alternative Water Supply.

Water from an approved source can be contaminated if inappropriately conveyed. 

Improperly constructed and maintained water mains, pumps, hoses, connections, and 

other appurtenances, as well as transport vehicles and containers, may result in 

contamination of safe water and render it hazardous to human health.

Materials

5-201.11 Approved.

Plumbing systems and hoses conveying water must be made of approved materials and 

be smooth, durable, nonabsorbent, and corrosion-resistant. If not, the system may 

constitute a health hazard because unsuitable surfaces may harbor disease organisms 

or it may be constructed of materials that may, themselves, contaminate the water 

supply.

Design, construction, and installation

5-202.11 Approved System and Cleanable Fixtures.

Water within a system will leach minute quantities of materials out of the components of 

the system. To make sure none of the leached matter is toxic or in a form that may 

produce detrimental effects, even through long-term use, all materials and components 

used in water systems must be of an approved type. New or replacement items must be 

tested and approved based on current standards.

Improperly designed, installed, or repaired water systems can have inherent 

deficiencies such as improper access openings, dead spaces, and areas difficult or 

impossible to clean and disinfect. Dead spaces allow water quality to degrade since 

they are out of the constant circulation of the system. Fixtures such as warewashing 

sinks that are not easily cleanable may lead to the contamination of food products. 
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5-202.12 Handwashing Sink, Installation.

Section 5-202.12 does not establish a temperature for washing hands. Rather, Section 

5-202.12 establishes criteria for the installation of handwashing sinks used in a retail 

food establishment that includes the temperature of the water delivered at the sink. 

Paragraph 5-202.12(A) states that a handwashing sink must be capable of delivering 

running water that is at least 29.4°C (85°F).

An inadequate flow or temperature of water may lead to poor handwashing practices by 

food employees. A mixing valve or combination faucet is needed to provide properly 

tempered water for handwashing. The International Plumbing Code (IPC) states that 

tempered water is having a temperature range between 29.4°C (85°F) and 43°C 

(110°F). Steam mixing valves are not allowed for this use because they are hard to 

control and injury by scalding is a possible hazard.

5-202.13 Backflow Prevention, Air Gap.

During periods of extraordinary demand, drinking water systems may develop negative 

pressure in portions of the system. If a connection exists between the system and a 

source of contaminated water during times of negative pressure, contaminated water 

may be drawn into and foul the entire system. Standing water in sinks, dipper wells, 

steam kettles, and other equipment may become contaminated with cleaning chemicals 

or food residue. To prevent the introduction of this liquid into the water supply through 

back siphonage, various means may be used. 

The water outlet of a drinking water system must not be installed so that it contacts 

water in sinks, equipment, or other fixtures that use water. Providing an air gap between 

the water supply outlet and the flood level rim of a plumbing fixture or equipment 

prevents contamination that may be caused by backflow. 

5-202.14 Backflow Prevention Device, Design Standard.

In some instances an air gap is not practical such as is the case on the lower rinse arm 

for the final rinse of warewashers. This arm may become submerged if the machine 

drain becomes clogged. If this failure occurs, the machine tank would fill to the flood 

level rim, which is above the rinse arm. A backflow prevention device is used to avoid 

potential backflow of contaminated water when an air gap is not practical. The device 

provides a break to the atmosphere in the event of a negative pressure within the 

system. Minerals contained in water and solid particulate matter carried in water may 

coat moving parts of the device or become lodged between them over time. This may 

render the device inoperative. 

To minimize such an occurrence, only devices meeting certain standards of 

construction, installation, maintenance, inspection, and testing for that application may 

be used. The necessary maintenance can be facilitated by installing these devices in 

accessible locations. 
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5-202.15 Conditioning Device, Design. 

Water conditioning devices must be designed for easy disassembly for servicing so that 

they can be maintained in a condition that allows them to perform the function for which 

they were designed. 

Numbers and capacities

5-203.11 Handwashing Sinks.

Because handwashing is such an important intervention in the control of foodborne 

illness, sufficient handwashing sinks must be available to make handwashing not only 

possible, but likely to occur at all appropriate times and places as outlined in Sections 2-

301.14 and 2-301.15.

According to Greig et el. (July 2007) an analysis of 816 reported outbreaks of infected 

worker-associated outbreaks from 1927-2006 found that over 61% of these outbreaks 

came from food service facilities and catered events, and another 11% of them are 

attributed to schools, day care centers and health care institutions. The two most 

frequently reported risk factors associated with these implicated food workers was bare 

hand contact with food, and failure to properly wash hands.

Green et al (JFP, March 2007) found that handwashing was more likely to occur in 

restaurants whose food workers received food safety training, had more than one 

handwashing sink, and had a handwashing sink in the observed worker's sight. This 

suggests that improving food worker hand hygiene requires more than food safety 

education.

5-203.12 Toilets and Urinals.

Adequate, sanitary toilet facilities are necessary for the proper disposal of human waste, 

which carries pathogenic microorganisms, and for preventing the spread of disease by 

flies and other insects. 

5-203.13 Service Sink.

Mop water and similar liquid wastes are contaminated with microorganisms and other 

filth. Waste water must be disposed of in a sanitary manner that will not contaminate 

food or food equipment. A service sink or curbed cleaning facility with a drain allows for 

such disposal. 

5-203.14 Backflow Prevention Device, When Required.

The delivery end of hoses attached to hose bibbs on a drinking water line may be 

dropped into containers filled with contaminated water or left in puddles on the floor or in 

other possible sources of contamination. A backflow prevention device must be installed 

on the hose bibb to prevent the back siphonage of contaminated liquid into the drinking 

water system during occasional periods of negative pressure in the water line. 
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5-203.15 Backflow Prevention Device, Carbonator.

When carbon dioxide is mixed with water, carbonic acid, a weak acid, is formed. 

Carbonators on soft drink dispensers form such acids as they carbonate the water to be 

mixed with the syrups to produce the soft drinks. If carbon dioxide backs up into a 

copper water line, carbonic acid will dissolve some of the copper. The water containing 

the dissolved copper will subsequently be used in dispensing soft drinks and the first 

few customers receiving the drinks are likely to suffer with the symptoms of copper 

poisoning. 

An air gap or a vented backflow prevention device meeting ASSE Standard No. 1022 

will prevent this occurrence, thereby reducing incidences of copper poisoning. 

Location and placement

5-204.11 Handwashing Sinks.

Hands are a common vehicle for the transmission of pathogens to foods in an 

establishment. Hands can become soiled with a variety of contaminants during routine 

operations. The transfer of contaminants can be limited by providing food employees 

with handwashing sinks that are properly equipped and conveniently located. 

A handwashing sink that is properly located is one that is available to food employees 

who are working in food preparation, food dispensing, and warewashing areas. 

Handwashing sinks that are blocked by portable equipment or stacked full of soiled 

utensils and other items, are rendered unavailable for employee use. Nothing must 

block the approach to a handwashing sink thereby discouraging its use, plus it must be 

kept clean and well stocked with soap and sanitary towels to facilitate frequent use. 

Therefore, a handwashing sink that is located in the immediate work area, or between 

work areas that the Code states must be equipped with handwashing sinks, depending 

upon the size and function of the facility, would be considered properly located. Such 

placement of handwashing sinks facilitates frequent handwashing by food employees in 

all work areas.

5-204.12 Backflow Prevention Device, Location. 

Backflow prevention devices are meant to protect the drinking water system from 

contamination caused by backflow. If improperly placed, backflow prevention devices 

will not work. If inconveniently located, these devices may not be accessed when 

systems are extended, altered, serviced, or replaced. Over a period of time, unserviced 

devices may fail and system contamination may occur.

5-204.13 Conditioning Device, Location.

When not located for easy maintenance, conditioning devices will be inconvenient to 

access and devices such as filters, screens, and water softeners will become clogged 

because they are not properly serviced. 
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Operation and maintenance

5-205.11 Using a Handwashing Sink.

Facilities must be maintained in a condition that promotes handwashing and restricted 

for that use. Convenient accessibility of a handwashing facility encourages timely 

handwashing which provides a break in the chain of contamination from the hands of 

food employees to food or food-contact surfaces. Sinks used for food preparation and 

warewashing can become sources of contamination if used as handwashing facilities by 

employees returning from the toilet or from duties which have contaminated their hands.

5-205.12 Prohibiting a Cross Connection. 

Nondrinking water may be of unknown or questionable origin. Waste water is either 

known or suspected to be contaminated. Neither of these sources can be allowed to 

contact and contaminate the drinking water system.

5-205.13 Scheduling Inspection and Service for a Water System Device.

Water system devices, such as filters and backflow preventers, are affected by the 

water in the system. How devices are affected depends on water quality, especially pH, 

hardness, and suspended particulate matter in the water. Complexity of the device is 

also a factor. Manufacturer recommendations, as well as inspection and maintenance 

schedules for these devices, must be strictly followed to prevent failure during 

operation.

Cleaning

5-205.14 Water Reservoir of Fogging

Devices, Cleaning.

Water reservoirs that have poor water exchange rates, such as reservoirs for some 

humidifiers or aerosol or fogging devices, and that are directly or indirectly open to the 

atmosphere, may be contaminated with respiratory pathogens such as Legionella 

pneumophila. This organism is extremely infectious and can be transmitted through

very small droplets of a fogger or humidifier. It is important that the manufacturer's 

cleaning and maintenance schedule be scrupulously followed to prevent a reservoir 

from colonization by this bacterium. 

5-205.15 System Maintained in Good Repair. 

Improper repair or maintenance of any portion of the plumbing system may result in 

potential health hazards such as cross connections, backflow, or leakage. These 

conditions may result in the contamination of food, equipment, utensils, linens, or singleservice or single-use articles. Improper repair or maintenance may result in the creation 

of obnoxious odors or nuisances, and may also adversely affect the operation of 

warewashing equipment or other equipment which depends on sufficient volume and 

pressure to perform its intended functions. 
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Materials

5-301.11 Approved.

Materials used in the construction of a mobile water tank are affected by the water they 

contact. Tank liners may deteriorate and flake. Metals or platings can be toxic. To 

prevent the degradation of the quality of the water, it is important that the materials used 

in the construction of the tank are suitable for such use. 

Design and construction

5-302.11 Enclosed System, Sloped to Drain. 

5-302.12 Inspection and Cleaning Port, Protected and Secured. 

The tank must be a closed system from the filling inlet to the outlet to prevent 

contamination of water. It is important that the bottom of the tank be sloped to the outlet 

to allow the tank to drain completely, to facilitate the proper cleaning and disinfection of 

the tank, and to prevent the retention of water or solutions after cleaning. 

Some tanks are designed with an access opening to facilitate the cleaning and servicing 

of the water tank. The access must be constructed to prevent the opening from 

becoming a source of contamination of the water.

5-302.13 "V" Type Threads, Use Limitation.

V-type threads are difficult to clean if contaminated with food or waste. To prevent the 

contamination of the drinking water, this type of thread should only be used on water 

tank inlets and outlets if the connection is permanent which eliminates exposed, difficultto-clean threads.

5-302.14 Tank Vent, Protected.

Water tanks are equipped with a vent to preclude distortion during filling or draining. The 

vent should be equipped with a suitable screen or filter to protect the tank against the 

entry of insects or other vermin that may contaminate the water supply.

5-302.15 Inlet and Outlet, Sloped to Drain.

Both the inlet and outlet must be sloped to drain to prevent the pooling of possibly 

contaminated water or sanitizing solution. 

5-302.16 Hose, Construction and Identification.

Hoses used to fill potable water tanks should be dedicated for that one task and should 

be identified for that use only to prevent contaminating the water. Hoses must be made 

of a material that will not leach detrimental substances into the water.
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Annex 3 - 191

Numbers and capacities

5-303.11 Filter, Compressed Air.

Compressor pistons are lubricated with oil to minimize wear. Some of the oil is carried 

into the air lines and if not intercepted may contaminate the tank and water lines.

5-303.12 Protective Cover or Device. 

Protective equipment provided for openings of the water supply must be in use to 

prevent contamination which may be present where the supply is exposed to the 

environment, i.e., at water inlets or outlets or the ends of transfer hoses.

5-303.13 Mobile Food Establishment Tank Inlet.

Mobile units may be particularly vulnerable to environmental contamination if soiled 

hose connections are coupled to the tank inlet.

Operation and maintenance

5-304.11 System Flushing and Disinfection.

Contaminants of various types may be introduced into a water system during 

construction or repair or other incidents. The system must be flushed and sanitized after 

maintenance and before it is placed into service to prevent contamination of the water 

introduced into the tank.

5-304.12 Using a Pump and Hoses, Backflow 

Prevention.

When a water system includes a pump, or a pump is used in filling a water tank, care 

must be taken during hookup to prevent negative pressure on the supplying water 

system. Backflow prevention to protect the water supply is especially necessary during 

cleaning and sanitizing operations on a mobile system.

5-304.13 Protecting Inlet, Outlet, and Hose Fitting.

When not connected for use, water inlets, outlets, and hose fittings should be closed to 

the environment. Unless capped or otherwise protected, filling inlets, outlets, and hoses 

may become contaminated by dust or vermin.

5-304.14 Tank, Pump, and Hoses, Dedication.

Hoses, pumps, and tanks used for food or water may not be used for other liquids 

because this may contaminate the water supply. If a hose, tank, or pump has been used 

to transfer liquid food, the equipment must be cleaned and sanitized before using it for 

water delivery. Failure to properly clean and sanitize the equipment would introduce 

nutrients, and possibly bacteria, into the water as well as inactivate residual chlorine 

from public water supplies. 
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Mobile holding tank

5-401.11 Capacity and Drainage.

Liquid waste from a mobile or temporary food establishment must be stored in a 

properly constructed waste tank to discourage the attraction of flies and other vermin. 

The waste tank must be 15% larger than the water storage tank to allow for storage of 

wastes and used water from the drinking water supply tank. The drain from the waste 

tank must be larger than the filling hose to prevent the use of the drinking water filling 

hose to drain the waste tank.

Retention, drainage, and delivery

5-402.10 Establishment Drainage System.

The drainage system must be designed and installed properly to prevent the backup of 

sewage and the possible contamination of foods or food-contact surfaces in the 

establishment.

5-402.11 Backflow Prevention.

Improper plumbing installation or maintenance may result in potential health hazards 

such as cross connections, back siphonage or backflow. These conditions may result in 

the contamination of food, utensils, equipment, or other food-contact surfaces. It may 

also adversely affect the operation of equipment such as warewashing machines. 

The exception in paragraph 5-402.11(B) allows for a direct connection to the sanitary 

sewer system for floor drains originating in refrigerated spaces that are constructed as 

an integral part of the building structure. Examples of refrigerated spaces that are 

considered an integral part of the building include refrigerated prep rooms, meat cutting 

rooms, and refrigerated storage rooms. The exception specifically targets refrigerated 

spaces that are considered an integral part of the building. It does not apply to 

prefabricated walk-in refrigerators and freezers with prefabricated floors. It is not 

intended to apply to pieces of equipment, including those which may be located in a 

refrigerated room and which indirectly drain to a floor drain within the room. Drainage 

from equipment is addressed under paragraph 5-402.11(A). 

5-402.12 Grease Trap.

Failure to locate a grease trap so that it can be properly maintained and cleaned could 

result in the harborage of vermin and/or the failure of the sewage system. 

5-402.13 Conveying Sewage.

5-402.14 Removing Mobile Food Establishment Waste. 

Improper disposal of waste provides a potential for contamination of food, utensils, and 

equipment and, therefore, may cause serious illness or disease outbreaks. Proper 
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removal is required to prevent contamination of ground surfaces and water supplies, or 

creation of other insanitary conditions that may attract insects and other vermin.

5-402.15 Flushing a Waste Retention Tank.

Thoroughly flushing the liquid waste retention tank will prevent the buildup of deposits 

within the tank which could affect the proper operation of the tank.

Disposal facility

5-403.11 Approved Sewage Disposal System.

Many diseases can be transmitted from one person to another through fecal 

contamination of food and water. This transmission can be indirect. Proper disposal of 

human wastes greatly reduces the risk of fecal contamination. This Code provision is 

intended to ensure that wastes will not contaminate ground surfaces or water supplies; 

pollute surface waters; be accessible to children or pets; or allow rodents or insects to 

serve as vectors of disease from this source. 

5-403.12 Other Liquid Waste and Rainwater.

Liquid food wastes and rainwater can provide a source of bacterial contamination and 

support populations of pests. Proper storage and disposal of wastes and drainage of 

rainwater eliminate these conditions.

Facilities on the premises

5-501.10 Indoor Storage Area.

5-501.11 Outdoor Storage Surface.

5-501.12 Outdoor Enclosure.

5-501.13 Receptacles.

5-501.14 Receptacles in Vending Machines.

5-501.15 Outside Receptacles. 

5-501.16 Storage Areas, Rooms, and Receptacles, Capacity and 

Availability.

5-501.17 Toilet Room Receptacle, Covered.

5-501.18 Cleaning Implements and Supplies. 

5-501.19 Storage Areas, Redeeming Machines, Receptacles and Waste

Handling Units, Location. 

5-501.110 Storage Refuse, Recyclables, and Returnables. 
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5-501.111 Areas, Enclosures, and Receptacles, Good Repair. 

5-501.112 Outside Storage Prohibitions.

5-501.113 Covering Receptacles.

5-501.114 Using Drain Plugs.

5-501.115 Maintaining Refuse Areas and Enclosures.

5-501.116 Cleaning Receptacles.

Proper storage and disposal of garbage and refuse are necessary to minimize the 

development of odors, prevent such waste from becoming an attractant and harborage 

or breeding place for insects and rodents, and prevent the soiling of food preparation 

and food service areas. Improperly handled garbage creates nuisance conditions, 

makes housekeeping difficult, and may be a possible source of contamination of food, 

equipment, and utensils. 

Storage areas for garbage and refuse containers must be constructed so that they can 

be thoroughly cleaned in order to avoid creating an attractant or harborage for insects or 

rodents. In addition, such storage areas must be large enough to accommodate all the 

containers necessitated by the operation in order to prevent scattering of the garbage 

and refuse.

All containers must be maintained in good repair and cleaned as necessary in order to 

store garbage and refuse under sanitary conditions as well as to prevent the breeding of 

flies.

Garbage containers should be available wherever garbage is generated to aid in the 

proper disposal of refuse. 

Outside receptacles must be constructed with tight-fitting lids or covers to prevent the 

scattering of the garbage or refuse by birds, the breeding of flies, or the entry of rodents. 

Proper equipment and supplies must be made available to accomplish thorough and 

proper cleaning of garbage storage areas and receptacles so that unsanitary conditions 

can be eliminated. 

Removal

5-502.11 Frequency.

5-502.12 Receptacles or Vehicles.

Refuse, recyclables, and returnable items, such as beverage cans and bottles, usually 

contain a residue of the original contents. Spillage from these containers soils 

receptacles and storage areas and becomes an attractant for insects, rodents, and 

other pests. The handling of these materials entails some of the same problems and 

solutions as the handling of garbage and refuse. Problems are minimized when all of 

these materials are removed from the premises at a reasonable frequency.
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Annex 3 - 195

Facilities for disposal and recycling

5-503.11 Community or Individual Facility.

Alternative means of solid waste disposal must be conducted properly to prevent 

environmental consequences and the attraction of insects, rodents, and other pests. 

Chapter 6. Physical Facilities

Indoor areas

6-101.11 Surface Characteristics.

Floors, walls, and ceilings that are constructed of smooth and durable surface materials 

are more easily cleaned.

Floor surfaces that are graded to drain and consist of effectively treated materials will 

prevent contamination of foods from dust and organisms from pooled moisture.

The special requirements for carpeting materials and nonabsorbent materials in areas 

subject to moisture are intended to ensure that the cleanability of these surfaces is 

retained.

Although food served from temporary food establishments is subject to the same 

potential for contamination as food served in permanent establishments, the limited 

capabilities and short duration of operation are recognized by less stringent 

requirements for surface characteristics. 

Outdoor areas

6-102.11 Surface Characteristics.

The requirements concerning surface characteristics of outdoor areas are intended to 

facilitate maintenance and minimize the accumulation of dust and mud on walking and 

driving areas, provide durable exterior building surfaces, and prevent the attracting, 

harboring, or breeding of insects, rodents, and other pests where refuse, recyclables, or 

returnables are stored.

Cleanability 

6-201.11 Floors, Walls, and Ceilings.

6-201.12 Floors, Walls, and Ceilings, Utility Lines.

Floors that are of smooth, durable construction and that are nonabsorbent are more 

easily cleaned. Requirements and restrictions regarding floor coverings, utility lines, and 

floor/wall junctures are intended to ensure that regular and effective cleaning is possible 

and that insect and rodent harborage is minimized.

6-201.13 Floor and Wall Junctures, Coved, and Enclosed or Sealed.
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Annex 3 - 196

When cleaning is accomplished by spraying or flushing, coving and sealing of the 

floor/wall junctures is required to provide a surface that is conducive to water flushing. 

Grading of the floor to drain allows liquid wastes to be quickly carried away, thereby 

preventing pooling which could attract pests such as insects and rodents or contribute 

to problems with certain pathogens such as Listeria monocytogenes.

6-201.14 Floor Carpeting, Restrictions and Installation.

Requirements and restrictions regarding floor carpeting are intended to ensure that 

regular and effective cleaning is possible and that insect harborage is minimized. The 

restrictions for areas not suited for carpeting materials are designed to ensure 

cleanability of surfaces where accumulation of moisture or waste is likely.

6-201.15 Floor Covering, Mats and Duckboards.

Requirements regarding mats and duckboards are intended to ensure that regular and 

effective cleaning is possible and that accumulation of dirt and waste is prevented.

6-201.16 Wall and Ceiling Coverings and Coatings.

6-201.17 Walls and Ceilings, Attachments.

6-201.18 Walls and Ceilings, Studs, Joists, and Rafters.

Walls and ceilings that are of smooth construction, nonabsorbent, and in good repair 

can be easily and effectively cleaned. Special requirements related to the attachment of 

accessories and exposure of wall and ceiling studs, joists, and rafters are intended to 

ensure the cleanability of these surfaces. 

Functionality

6-202.11 Light Bulbs, Protective Shielding.

Shielding of light bulbs helps prevent breakage. Light bulbs that are shielded, coated, or 

otherwise shatter-resistant are necessary to protect exposed food, clean equipment, 

utensils and linens, and unwrapped single-service and single-use articles from glass 

fragments should the bulb break. 

6-202.12 Heating, Ventilating, Air Conditioning System Vents.

Heating and air conditioning system vents that are not properly designed and located 

may be difficult to clean and result in the contamination of food, food preparation 

surfaces, equipment, or utensils by dust or other accumulated soil from the exhaust 

vents. 

6-202.13 Insect Control Devices, Design and Installation.

Insect electrocution devices are considered supplemental to good sanitation practices in 

meeting the Code requirement for controlling the presence of flies and other insects in a 

food establishment. 
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Annex 3 - 197

Improper design of the device and dead insect collection tray could allow dead insect 

parts and injured insects to escape, rendering the device itself a source of 

contamination.

Exposed food and food-contact surfaces must be protected from contamination by 

insects or insect parts. Installation of the device over food preparation areas or in close 

proximity to exposed food and/or food-contact surfaces could allow dead insects and/or 

insect parts to be impelled by the electric charge, fall, or be blown from the device onto 

food or food-contact surfaces.

6-202.14 Toilet Rooms, Enclosed.

Completely enclosed toilet facilities minimize the potential for the spread of disease by 

the movement of flies and other insects between the toilet facility and food preparation 

areas.

6-202.15 Outer Openings, Protected. 

Insects and rodents are vectors of disease-causing microorganisms which may be 

transmitted to humans by contamination of food and food-contact surfaces. The 

presence of insects and rodents is minimized by protecting outer openings to the food 

establishment. 

In the National Fire Protection Association’s NFPA 101, Life Safety Code, 2009 Edition, 

doors to exit enclosures such as stairs, horizontal exits, or exit passageways are 

required to be self closing. The Life Safety Code does not require exterior doors used 

as exits to be self closing, but they can be. 

The intent of subparagraph 6-202.15(A)(3) is to protect food establishments from the 

entry of insects and rodents by keeping doors closed when not in use. Self-closing 

devices allow a door to return to its closed position after use. If an exterior door is not 

routinely used for entry or exit because its use is restricted by the fire protection 

authority for emergency use only, it is not a portal for the entry of pests and does not 

need a self-closing device. Doors not requiring a self-closing device include exterior 

emergency exit doors that open into a public way from a fire and that meet the criteria in 

¶ 6-202.15(C). 

6-202.16 Exterior Walls and Roofs, Protective Barrier.

Walls and roofs provide a barrier to protect the interior and foods from the weather, 

windblown dirt and debris, and flying insects. 

6-202.17 Outdoor Food Vending Areas, Overhead Protection.

The potential for contamination from airborne dust and particulates or inclement 

weather is present in outside areas. Overhead protection minimizes the potential for 

contamination of food under such conditions. 

6-202.18 Outdoor Servicing Areas, Overhead Protection.
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Annex 3 - 198

Pooled water, which may result if overhead protection is not provided for outdoor 

servicing areas, attracts wild animals and birds and creates a condition suitable for the 

breeding of insects.

6-202.19 Outdoor Walking and Driving Surfaces, Graded to Drain.

If foot traffic is allowed to occur from undrained areas, contamination will be tracked into 

the establishment. Surfaces graded to drain minimize these conditions. Pooled water on 

exterior walking and driving surfaces may also attract rodents and breed insects. 

6-202.110 Outdoor Refuse Areas, Curbed and Graded to Drain. 

If refuse areas are not graded properly, waste water will pool and attract insects and 

rodents.

6-202.111 Private Homes and Living or Sleeping Quarters, Use 

Prohibited.

6-202.112 Living or Sleeping Quarters, Separation.

Areas or facilities that are not compatible with sanitary food establishment operations 

must be located or separated from other areas of the establishment to preclude 

potential contamination of food and food-contact surfaces from poisonous or toxic 

materials, dust or debris, the presence of improperly designed facilities and equipment, 

and the traffic of unauthorized and/or unnecessary persons or pets.

Further, Article IV of the Amendments to the U.S. Constitution ensures the right of 

persons to be secure in their homes against unreasonable search and seizure. This 

provision could hinder the regulatory authority's access to conduct routine inspections of 

a food establishment operated in the living area of a private home. A search warrant 

may be the only mechanism by which to gain entry; yet, it may be difficult to obtain and 

might not authorize the necessary inspectional activities.

Handwashing sinks

6-301.10 Minimum Number.

Refer to the public health reason for § 5-203.11. 

6-301.11 Handwashing Cleanser, Availability.

Hand cleanser must always be present to aid in reducing microorganisms and 

particulate matter found on hands. 

6-301.12 Hand Drying Provision.

Provisions must be provided for hand drying so that employees will not dry their hands 

on their clothing or other unclean materials. 
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Annex 3 - 199

It is known that wet hands transfer bacteria more readily than dry hands. The residual 

moisture found on the hands after washing allows for bacterial and viral transfer to food 

or solid surfaces by touch. The method in which hands are dried is a critical factor in 

reducing chances of cross-contamination by hands to food and environmental surfaces 

(Patrick et al., (1997)).

With regard to the addition of air knife technology for hand drying, data reviewed by 

FDA scientists at the FDA’s National Center for Food Safety Technology (Moffitt Center) 

demonstrates that the use of this technology in hand dryers has been found to be 

equivalent to the hand drying treatment in existing heated-air devices.

While the Food Code does not specifically address the configuration or ergonomic 

design of hand drying devices, technologies employing air knife systems do not appear 

to accommodate the drying of one’s arms and may not be large enough to 

accommodate surrogate prosthetic devices for hands and arms to fit within the handdryer. In the case where food employees are expected to wash their forearms or are 

fitted with a surrogate prosthetic device, the food establishment would need to provide 

an alternate means for drying of the arms and certain prosthetic devices. 

6-301.14 Handwashing Signage. 

A sign or poster is required to remind food employees to wash their hands. 

6-301.20 Disposable Towels, Waste Receptacle.

Waste receptacles at handwashing sinks are required for the collection of disposable 

towels so that the paper waste will be contained, will not contact food directly or 

indirectly, and will not become an attractant for insects or rodents.

Toilets and urinals

6-302.10 Minimum Number.

Refer to the public health reason for § 5-203.12.

6-302.11 Toilet Tissue, Availability.

To minimize hand contact with fecal waste, toilet tissue is necessary for hygienic 

cleaning following use of toilet facilities. Toilet tissue must be supplied to meet the 

demand.

Lighting

6-303.11 Intensity.

Lighting levels are specified so that sufficient light is available to enable employees to 

perform certain functions such as reading labels; discerning the color of substances; 

identifying toxic materials; recognizing the condition of food, utensils, and supplies; and 

safely conducting general food establishment operations and clean-up. 
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Annex 3 - 200

Properly distributed light makes the need for cleaning apparent by making 

accumulations of soil conspicuous.

Ventilation

6-304.11 Mechanical.

When mechanical ventilation is necessary, it must have adequate capacity to ensure 

that soiling of walls, ceilings, and other equipment is minimized; obnoxious odors or 

toxic fumes are effectively removed; and no hazards or nuisances involving 

accumulation of fats, oils, and similar wastes are created.

Balancing of the exhaust and make-up air must be ensured so that the system can 

operate efficiently.

Dressing areas and lockers

6-305.11 Designation.

Street clothing and personal belongings can contaminate food, food equipment, and 

food-contact surfaces. Proper storage facilities are required for articles such as purses, 

coats, shoes, and personal medications. 

Service sinks

6-306.10 Availability.

A service sink or curbed facility is required so that the cleanliness of the food 

establishment can be maintained, attractants for insects and rodents minimized, and 

contamination of food and equipment by accumulated soil prevented. Liquid wastes 

generated during cleaning must be disposed of in a sanitary manner to preclude 

contamination of food and food equipment. A service sink is provided to prevent the 

improper disposal of wastes into other sinks such as food preparation and handwashing 

sinks.

Handwashing sinks

6-401.10 Conveniently Located.

Facilities must be located in or adjacent to toilet rooms and convenient to the different 

work stations of the food employee for proper and routine handwashing to prevent 

contamination of the food and food-contact surfaces.

Toilet rooms

6-402.11 Convenience and Accessibility.

Toilet rooms must be conveniently accessible to food employees at all times to 

encourage employee use of appropriate facilities for the disposing of human wastes as 

needed followed by the washing of hands.
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Annex 3 - 201

Employee accommodations

6-403.11 Designated Areas.

Because employees could introduce pathogens to food by hand-to-mouth-to-food 

contact and because street clothing and personal belongings carry contaminants, areas 

designated to accommodate employees' personal needs must be carefully located. 

Food, food equipment and utensils, clean linens, and single-service and single-use 

articles must not be in jeopardy of contamination from these areas.

Distressed merchandise

6-404.11 Segregation and Location.

Products which are damaged, spoiled, or otherwise unfit for sale or use in a food 

establishment may become mistaken for safe and wholesome products and/or cause 

contamination of other foods, equipment, utensils, linens, or single-service or single-use 

articles. To preclude this, separate and segregated areas must be designated for 

storing unsalable goods. 

Refuse, recyclables, and returnables

6-405.10 Receptacles, Waste Handling Units, and Designated Storage 

Areas.

Waste materials and empty product containers are unclean and can be an attractant to 

insects and rodents. Food, equipment, utensils, linens, and single-service and singleuse articles must be protected from exposure to filth and unclean conditions and other 

contaminants. This Code provision addresses these concerns by requiring the facility to 

be segregated, to be located to allow cleaning of adjacent areas, and to preclude 

creation of a nuisance.

Premises, structures, attachments, and fixtures, - methods

6-501.11 Repairing.

Poor repair and maintenance compromises the functionality of the physical facilities. 

This requirement is intended to ensure that the physical facilities are properly 

maintained in order to serve their intended purpose.

6-501.12 Cleaning, Frequency and Restrictions.

Cleaning of the physical facilities is an important measure in ensuring the protection and 

sanitary preparation of food. A regular cleaning schedule should be established and 

followed to maintain the facility in a clean and sanitary manner. Primary cleaning should 

be done at times when foods are in protected storage and when food is not being 

served or prepared.

6-501.13 Cleaning Floors, Dustless Methods. 
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Annex 3 - 202

Dustless floor cleaning methods must be used so that food; equipment, utensils, and 

linens; and single-service and single-use articles are not contaminated.

6-501.14 Cleaning Ventilation Systems, Nuisance and Discharge 

Prohibition.

Both intake and exhaust ducts can be a source of contamination and must be cleaned 

regularly. Filters that collect particulate matter must be cleaned or changed frequently to 

prevent overloading of the filter. Outside areas under or adjacent to exhaust duct outlets 

at the exterior of the building must be maintained in a clean and sanitary manner to 

prevent pest attraction.

6-501.15 Cleaning Maintenance Tools, Preventing 

Contamination.

Maintenance tools used to repair the physical facilities must be cleaned in a separate 

area to prevent contamination of food and food preparation and warewashing areas.

6-501.16 Drying Mops.

Mops can contaminate food and food preparation areas if not properly cleaned and 

stored after use. Mops should be cleaned and dried in a sanitary manner away from 

food flow areas.

6-501.17 Absorbent Materials on Floors, Use Limitation.

Cleanliness of the food establishment is important to minimize attractants for insects 

and rodents, aid in preventing the contamination of food and equipment, and prevent 

nuisance conditions. A clean and orderly food establishment is also conducive to 

positive employee attitudes which can lead to increased attention to personal hygiene 

and improved food preparation practices. Use of specified cleaning procedures is 

important in precluding avoidable contamination of food and equipment and nuisance 

conditions.

Temporary floor coverings such as sawdust can contaminate food, attract insects and 

rodents, and become a nuisance to the food operation. 

6-501.18 Cleaning of Plumbing Fixtures. 

Handwashing facilities are critical to food protection and must be maintained in 

operating order at all times so they will be used. 

Refer also to the public health reason for § 5-205.11.

Toilet facilities must be of sanitary design and kept clean and in good repair to prevent 

food contamination and to motivate employees to use sanitary practices in the 

establishment.
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Annex 3 - 203

Hand contact with contaminated surfaces can result in self-inoculation by touching of 

the nose and mouth. The spread of Shigella sonnei in a nursery school has been traced 

to contaminated toilets. Experiments by Gerba, et al and Barker and Bloomfield have 

shown that when bacteria and viruses were seeded into a household toilet, the 

detection of bacteria and viruses in the fallout droplets from the aerosols produced 

when flushing remain airborne long enough to settle on surfaces throughout the 

bathroom. Barker and Bloomfield also demonstrated that Salmonella Enteritidis could 

be isolated from the air surrounding a household toilet after flushing the toilet. 

Noroviruses which are a major cause of gastroenteritis can be transmitted by fecal-oral, 

airborne inhalation, person-to-person and environmental-to-person routes. Norovirus, 

which is highly infectious, is shed in vomitus and stool in high numbers. A study was 

conducted by J. Barker et al to look at the transmission of norovirus via fingers, cloths 

and contact surfaces. The results indicated that where fingers come into contact with 

virus-contaminated toilet tissue, norovirus is consistently transferred via the fingers to a 

melamine surface and from there to other typical hand-contact surfaces such as taps, 

door handles and telephone receivers. In this study epidemiological evidence suggests 

that environmental spread from an infective person occurs by settling of aerosol 

particles on to contact surfaces. Hands can then spread the virus when they touch toilet 

seats or flush handles contaminated by splash from vomit or aerosol particles generated 

during toilet flushing. 

6-501.19 Closing Toilet Room Doors.

Toilet room doors must remain closed except during cleaning operations to prevent 

insect and rodent entrance and the associated potential for the spread of disease.

6-501.110 Using Dressing Rooms and Lockers.

Street clothing and personal belongings can contaminate food, food equipment, and 

food preparation surfaces and consequently must be stored in properly designated 

areas or rooms.

6-501.111 Controlling Pests.

Insects and other pests are capable of transmitting disease to humans by contaminating 

food and food-contact surfaces. Effective measures must be taken to eliminate their 

presence in food establishments.

6-501.112 Removing Dead or Trapped Birds, Insects, Rodents, and Other 

Pests.

Dead rodents, birds, and insects must be removed promptly from the facilities to ensure 

clean and sanitary facilities and to preclude exacerbating the situation by allowing 

carcasses to attract other pests.

6-501.113 Storing Maintenance Tools. 
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Annex 3 - 204

Brooms, mops, vacuum cleaners, and other maintenance equipment can contribute 

contamination to food and food-contact surfaces. These items must be stored in a 

manner that precludes such contamination.

To prevent harborage and breeding conditions for rodents and insects, maintenance 

equipment must be stored in an orderly fashion to permit cleaning of the area.

6-501.114 Maintaining Premises, Unnecessary Items and Litter.

The presence of unnecessary articles, including equipment which is no longer used, 

makes regular and effective cleaning more difficult and less likely. It can also provide 

harborage for insects and rodents. 

Areas designated as equipment storage areas and closets must be maintained in a 

neat, clean, and sanitary manner. They must be routinely cleaned to avoid attractive or 

harborage conditions for rodents and insects.

6-501.115 Prohibiting Animals.

Animals carry disease-causing organisms and can transmit pathogens to humans 

through direct and/or indirect contamination of food and food-contact surfaces. The 

restrictions apply to live animals with limited access allowed only in specific situations 

and under controlled conditions and to the storage of live and dead fish bait. Employees 

with service animals are required under § 2-301.14 to wash their hands after each 

contact with animals to remove bacteria and soil. 

Animals shed hair continuously and may deposit liquid or fecal waste, creating the need 

for vigilance and more frequent and rigorous cleaning efforts. 

The definition for "service animal" is adapted from 28 CFR 36.104 adopted pursuant to 

the Americans with Disabilities Act (ADA) of 1990 (42 U.S.C. 12101 et seq.). A service 

animal performs some of the functions that persons with a disability cannot perform for 

themselves, such as those provided by "seeing eye dogs"; alerting persons with hearing 

impairments to sounds; pulling wheelchairs or carrying and picking up things for 

persons with mobility impairments; and assisting persons with mobility impairments with 

balance. A service animal is not considered to be a pet. 

Under Title III of the ADA, privately owned businesses that serve the public are 

prohibited from discriminating against individuals with disabilities. The ADA requires 

these businesses to allow people with disabilities to bring their service animals onto 

business premises in whatever areas customers are generally allowed. Some, but not 

all, service animals wear special collars or harnesses. Some, but not all, are licensed or 

certified and have identification papers. 

Decisions regarding a food employee or applicant with a disability who needs to use a 

service animal should be made on a case-by-case basis. An employer must comply with 

health and safety requirements, but is obligated to consider whether there is a 

reasonable accommodation that can be made. Guidance is available from the U.S. 

Department of Justice, Civil Rights Division, Disability Rights Section or the U.S. Equal 
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Annex 3 - 205

Employment Opportunity Commission, the Federal agency which has the lead in these 

matters, in documents such as, “Commonly Asked Questions About Service Animals in 

Places of Business”; “The Americans with Disabilities Act Questions and Answers”; “A 

Guide to Disability Rights Laws”; and “Americans with Disabilities Act Title III Technical 

Assistance Manual, 1994 Supplement.” The ADA Information Line is 800-514-0301 

(voice) or 800-514-0383 (TDD) and the Internet Home Page address is http://adata.org/. 

Food establishments that choose to allow pet dogs in outdoor dining areas must be 

APPROVED to do so. There are public health concerns regarding the approval of pet 

dogs in outdoor dining areas that must be carefully considered and controlled. When 

developing a plan for approval there are key areas of consideration to address hazards 

associated with allowing pet dogs in outdoor dining areas, such as:

a) The vaccination status of the pet dog.

b) Ensuring consumers properly restrain or contain the pet dog and prevent the pet 

dog from serving as a source of contamination by preventing access to waitstaff, 

consumer food, utensils, linens, and single-service items, as well as food contact 

surfaces such as tables and chairs, including during entrance and egress

c) Signage alerting patrons to increased risk and designated areas for pet dogs.

d) Ensuring compliance with local ordinances (for example: related to sidewalks, 

public nuisance, sanitation, size and breed restrictions, etc.)

e) Preparing or serving food and water to dogs, if done, how will those items be 

contained, designated, and handled to prevent cross-contamination with food, 

equipment, utensils, linens, and single service items for humans. Note: All food 

prepared and served to dogs must not be adulterated or misbranded and is 

subject to applicable LAW.

f) Maintaining the outdoor dining area, including the exterior walls and floors clean 

and ensuring surfaces that have been contaminated with dog excrement or other 

bodily fluids (urine, saliva, and vomit, etc.) are cleaned and sanitized

g) Providing a covered refuse container exclusively to store all pet waste generated, 

h) Developing a protocol for requesting that a pet dog owner remove from the 

establishment any dog that menaces, threatens or bites any person or other dog, 

and reporting said incident to the appropriate health authority.
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Chapter 7. Poisonous or Toxic Materials

Original containers

7-101.11 Identifying Information, Prominence.

The accidental contamination of food or food-contact surfaces can cause serious 

illness. Prominent and distinct labeling helps ensure that poisonous and toxic materials 

including personal care items are properly used. 

Working containers

7-102.11 Common Name.

It is common practice in food establishments to purchase many poisonous or toxic 

materials including cleaners and sanitizers in bulk containers. Working containers are 

frequently used to convey these materials to areas where they will be used, resulting in 

working containers being stored in different locations in the establishment. Identification 

of these containers with the common name of the material helps prevent the dangerous 

misuse of the contents.

Storage

7-201.11 Separation. 

Separation of poisonous and toxic materials in accordance with the requirements of this 

section ensures that food, equipment, utensils, linens, and single-service and single-use 

articles are properly protected from contamination. For example, the storage of these 

types of materials directly above or adjacent to food could result in contamination of the 

food from spillage. 

Presence and use 

7-202.11 Restriction. 

The presence in the establishment of poisonous or toxic materials that are not required 

for the maintenance and operation of the establishment represents an unnecessary risk 

to both employees and consumers. 

Preserving food safety depends in part on the appropriate and proper storage and use 

of poisonous or toxic materials that are necessary to the maintenance and operation of 

a food establishment. Even those that are necessary can pose a hazard if they are used 

in a manner that contradicts the intended use of the material as described by the 

manufacturer on the material's label. If additional poisonous or toxic materials are 

present, there is an unwarranted increased potential for contamination due to improper 

storage (e.g., overhead spillage that could result in the contamination of food, foodcontact surfaces, or food equipment) or inappropriate application.
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7-202.12 Conditions of Use.

Failure to properly use poisonous or toxic materials can be dangerous. Many poisonous 

or toxic materials have general use directions on their label. Failure to follow the stated 

instructions could result in injury to employees and consumers through direct contact or 

the contamination of food.

Particular precautions must be taken during the application of poisonous or toxic 

materials to prevent the contamination of food and other food-contact surfaces. 

Residues of certain materials are not discernible to the naked eye and present an 

additional risk to the employee and consumer. 

Because of the toxicity of restricted use pesticides, they can only be applied by certified 

operators. A certified operator would be aware of the dangers involved in the 

contamination of food and food-contact surfaces during the application of these 

materials. Improperly applied pesticides present health risks to employees as well as 

consumers and special precautions must be taken when restricted use pesticides are 

applied. 

Container prohibitions

7-203.11 Poisonous or Toxic Material Containers.

Use of poisonous or toxic material containers to store, transport, or dispense food is 

prohibited because of the potential for contamination of the food. The risk of serious 

medical consequences to anyone consuming food stored in these containers coupled 

with the lack of confidence that all of the material could or would be removed in the 

wash and sanitizing procedures are reasons for prohibiting this practice.

Chemicals

7-204.11 Sanitizers, Criteria.

See explanation in §4-501.114. 

Chemical sanitizers are included with poisonous or toxic materials because they may be 

toxic if not used in accordance with requirements listed in the Code of Federal 

Regulations (CFR). Large concentrations of sanitizer in excess of the CFR requirements 

can be harmful because residues of the materials remain. The CFR reference that is 

provided lists concentrations of sanitizers that are considered safe.

Section 7-204.11 addresses whether or not the chemical agent being applied as a 

sanitizer is approved and listed for that use under 40 CFR 180.940, Tolerance 

exemptions for active and inert ingredients for use in antimicrobial formulations (food 

contact sanitizing solutions) or 40 CFR 180.2020, Non-food determinations. Because 

there is no EPA registration of solutions generated and used on-site, the user of the 

equipment should look to the equipment manufacturer for data to validate the efficacy of 

the solution that is generated by the device as well as the conditions for use of the 

solution.
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Some sanitizers produced by on-site generators are based on gases dissolved in 

solution. These may present toxicology issues if the gases can come out of solution and 

into the air at high concentrations. Occupational Safety and Health Administration 

(OSHA) limits on gases like ozone and chlorine dioxide are outlined in 29 CFR 

1910.1000, Air contaminants. Although the amount of dissolved gas in solution may be 

very low when evenly distributed through out all the air in a site, the gas may not be 

evenly distributed. This may lead to localized concentrations, e.g., immediately over a 

three compartment sink, that exceed OSHA limits. It is the responsibility of the permit 

holder and equipment supplier to ensure that the equipment is used in a safe manner so 

that OSHA limits will not be exceeded anywhere in the permit holder's facility.

7-204.12 Chemicals for Washing Fruits and Vegetables, Criteria.

7-204.13 Boiler Water Additives, Criteria.

7-204.14 Drying Agents, Criteria.

If the chemical wash, boiler water additive, or drying agent used is not made up of 

components that are approved as food additives or generally recognized as safe, illness 

may result. This could be due to residues that may remain from the use of compounds 

such as unrecognized drying agents. This is why only those chemicals that are 

approved food additives or food-contact substances, generally recognized as safe, prior 

sanctioned or exempted by the threshold of regulation process can be used. Information 

regarding food contact substances notification may be found on the FDA website under 

the Food Topic in Ingredients and Packaging section at: 

http://www.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/default.htm

Chemicals that are not generally recognized as safe, or not authorized by FDA for these 

uses may be submitted for review by filing a Food Additive Petition, a Food Contact 

Notification (FCN), or a request for exemption under the Threshold of Regulation. Wash 

chemicals, boiler water additives, and drying agents are classified as food additives 

because of the possibility that they may end up in food. Therefore, they are subject to 

review before being used or listed in the CFR. If the chemicals are hard food-contact 

sanitizers, or washes for raw agricultural commodities (RACs) that are used on a farm 

or in a packing house, then this is under the jurisdiction of the EPA. 

21 CFR 173 Secondary Direct Food Additives Permitted in Food for Human 

Consumption includes a number of regulations permitting certain food additives to be 

used for washing fruits and vegetables. In an effort to be consistent with federal law a 

change was made in Section 7-204.12 Chemicals for Washing, Treatment, Storage and 

Processing Fruits and Vegetables, Criteria to include all of 21 CFR 173 so as not to 

exclude the use of other permitted food additives. There is also another mechanism for 

approval of antimicrobial agents for washing fruits and vegetables (i.e., the food contact 

notification program) as well as GRAS ingredients permitted as antimicrobials or for 

general food use. This revision allows for the use of ingredients that are GRAS for this 

use and food contact substances which were the subject of an effective food contact 

notification for this use. 21 CFR 173 includes permitted food additives such as those 

listed in 21 CFR 173.315 Chemicals used in the washing or to assist in the peeling of 

fruits and vegetables. This section specifically identifies some of the chemicals that may 
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Annex 3 - 209

be used in washing fruits and vegetables, regardless of whether the chemicals are 

commercially produced or generated on site. Sodium hypochlorite is listed in 21 CFR 

173.315 for use in washing fruits and vegetables at levels not exceeding the minimum 

amount required to accomplish the intended technical effect. FDA has no objection to 

the use of calcium hypochlorite in the place of sodium hypochlorite under 21 CFR 

173.315.

On December 4, 2012, the FDA amended the food additive regulations to provide for 

the safe use of sodium dodecylbenzenesulfonate (SDBS) (CAS No. 25155-30-0) as an 

antimicrobial agent for use in wash water for fruits and vegetables without the 

requirement of a potable water rinse. 21 CFR Section 173.405 specifically identifies this 

additive as an antimicrobial agent used in wash water for fruits and vegetables. The 

additive may be used at a level not to exceed 111 milligrams per kilogram in the wash 

water. Fruits and vegetables treated by the additive do not require a potable water rinse. 

Use of this additive is limited to use in commissaries, cafeterias, restaurants, retail food 

establishments, nonprofit food establishments and other food service operations in 

which food is prepared for or served directly to the consumer. To ensure safe use of the 

additive, refer to the label or labeling of the additive and/or antimicrobial pesticide 

container for adequate directions. Information on the label is required in accordance to

provisions within 21 CFR 173.405 and the Federal Food, Drug and Cosmetic Act. 

Although the petitioned use of SDBS is regulated under Section 409 of the FD & C Act 

as a food additive, this intended use of SDBS may nevertheless be subject to regulation 

as a pesticide under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). 

EPA requirements pertain to EPA registered pesticide products that have uses subject 

to EPA or both FDA and EPA regulations. Therefore, manufacturers intending to use 

this food additive for this intended use should contact the Environmental Protection 

Agency to determine whether this use requires a pesticide registration under FIFRA.

Boiler water additives that may be safely used in the preparation of steam that may 

contact food, and their condition of use, are identified in 21 CFR 173.310 Boiler Water 

Additives.

Lubricants

7-205.11 Incidental Food Contact, Criteria.

Lubricants used on food equipment may directly or indirectly end up in the food. 

Therefore, the lubricants used must be approved as food additives or generally 

recognized as safe and listed in the CFR. Lubricants that are not safe present the 

possibility of foodborne illness if they find their way into the food. 

Pesticides

7-206.11 Restricted Use Pesticides, Criteria.

7-206.12 Rodent Bait Stations. 
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Annex 3 - 210

Open bait stations may result in the spillage of the poison being used. Also, it is easier 

for pests to transport the potentially toxic bait throughout the establishment. 

Consequently, the bait may end up on food-contact surfaces and ultimately in the food 

being prepared or served. 

7-206.13 Tracking Powders, Pest Control and Monitoring. 

The use of tracking powder pesticides presents the potential for the powder to be 

dispersed throughout the establishment. Consequently, the powder could directly or 

indirectly contaminate food being prepared. This contamination could adversely affect 

both the safety and quality of the food and, therefore, tracking powder pesticides are not 

allowed. 

Medicines

7-207.11 Restriction and Storage. 

Medicines that are not necessary for the health of employees present an unjustified risk 

to the health of other employees and consumers due to misuse and/or improper 

storage. 

There are circumstances that require employees or children in a day care center to 

have personal medications on hand in the establishment. To prevent misuse, personal 

medications must be labeled and stored in accordance with the requirements stated for 

poisonous or toxic materials. Proper labeling and storage of medicines to ensure that 

they are not accidentally misused or otherwise contaminate food or food-contact 

surfaces. 

7-207.12 Refrigerated Medicines, Storage.

Some employee medications may require refrigerated storage. If employee medications 

are stored in a food refrigerator, precautions must be taken to prevent the contamination 

of other items stored in the same refrigerator. 

First aid supplies

7-208.11 Storage.

First aid supplies for employee use must be identified and stored in accordance with the 

requirements of this Code in order to preclude the accidental contamination of food, 

food equipment, and other food-contact surfaces.

Other personal care items

7-209.11 Storage.

Employee personal care items may serve as a source of contamination and may 

contaminate food, food equipment, and food-contact surfaces if they are not properly 

labeled and stored. 
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Storage and display

7-301.11 Separation. 

Poisonous or toxic materials held for sale on store shelves or stored in stock rooms 

present a risk of contamination of food, equipment, utensils, linens, and single-service 

and single-use articles if not stored properly. 

Chapter 8. Compliance and Enforcement

Construction inspection and approval

8-201.12 Contents of the Plans and Specifications. 

8-203.10 Preoperational Inspections. 

In conjunction with the Conference for Food Protection Plan Review committee, FDA 

has participated in developing a document that is intended to assist regulators in 

reviewing food establishment plans, and industry in understanding what is expected in 

the plan review process. For several years, this FDA/CFP Food Establishment Plan 

Review Guide – 2000 has been used in the FDA State Training Team Plan Review 

courses. It can be accessed through 

http://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/IndustryandRegulat

oryAssistanceandTrainingResources/ucm101639.htm. 

At the plan review stage, the regulatory authority may be dealing with an agent of the 

permit applicant who is seeking a building permit and who is not in a position to discuss 

plans for safely conducting the food operation. Nonetheless, the plan review step 

presents a unique opportunity to lay a foundation that enables the proposed operation 

to proactively sustain compliance with the Code over time. Standard operating 

procedures (SOPs) are a part of that foundation and ideally are developed in tandem 

with designing the facility. Consequently, as an integral part of the plan review process, 

discussion needs to occur about such procedures and their scope. 

SOPs need to be developed by the time of the preoperational inspection and put into 

effect when the food operation begins. It is recommended that such procedures be 

written, available for reference by the person in charge, conveyed to the appropriate 

employees, and available for review by the regulatory authority during inspections. 

Operating procedures should include definitive practices and expectations that ensure 

that: 

1. The transmission of foodborne disease is prevented by managing job applicants 

and food employees as specified under Subpart 2-201,

2. Food is received from approved sources as specified under § 3-201.11,

3. Food is managed so that the safety and integrity of the food from the time of 

delivery to the establishment throughout its storage, preparation, and 

transportation to the point of sale or service to the consumer is protected,
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Annex 3 - 212

4. Time/temperature control for safety food is maintained, including freezing, cold 

holding, cooking, hot holding, cooling, reheating, and serving in conformance 

with the temperature and time requirements specified under Parts 3-4 and 3-5,

5. Warewashing is effective, including assurance that the chemical solutions and 

exposure times necessary for cleaning and sanitizing utensils and food-contact 

surfaces of equipment are provided as specified under Parts 4-6 and 4-7, and

6. Records that are specified under §§ 3-203.11, 3-203.12, and 5-205.13 are 

retained for inspection. 

During the plan review stage, the regulatory authority and a management representative 

of the proposed food establishment should discuss available training options that may 

be used to train food employees and the person in charge regarding food safety as it 

relates to their assigned duties. By the time of the preoperational inspection, operating 

procedures for training should include definitive practices and expectations of how the 

management of the proposed food establishment plans to comply with paragraph 2-

103.11(N) of this Code which requires the person in charge to assure that food 

employees are properly trained in food safety as it relates to their assigned duties. 

8-304.11 Responsibility of the Permit Holder

It is important that regulatory agencies comply with applicable laws related to disclosure 

of public information. Making inspection reports available to the public promotes 

transparency and allows the public to be better informed about the businesses they 

patronize and the government agencies that serve the public. The intent is to improve 

industry and regulatory practices related to food safety at the foodservice and retail 

level.

8-402.10 Competency of Inspectors. 

Regulatory agencies are encouraged to use Standard #2 of the draft FDA’s 

Recommended National Retail Food Regulatory Program Standards 

(http://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/ProgramStandards

/default.html) to ensure employees who inspect food establishments are properly 

trained. Regulatory inspectors are also encouraged to seek food safety certification 

through a nationally recognized and accredited program.

8-403.50 Public Information.

Regulatory documents that describe the compliance status of a regulated food 

establishment may be of particular interest to consumers, academia, industry, and other 

regulators. Certain laws may obligate government entities to make regulatory 

documents available to the public upon request. Proactively making these documents 

available to the public, by way of a website, may reduce the burden associated with 

requesting these documents, and therefore make it more likely that these documents 

will be accessible and reviewed by interested stakeholders. 

8-404.11 Ceasing Operations and Reporting.
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During crisis, industry and public health are partners with a common purpose; to restore 

normalcy to the community quickly while protecting the public health in the process. 

Pre-approval of emergency operating plans by the regulatory authority enables food 

establishments to remain in operation under conditions of loss of electrical service or 

water service and allows the regulatory authority to ensure in advance that appropriate 

precautions are planned for and taken to provide food safety protections under predetermined and agreed upon parameters.

8-501.20 Restriction or Exclusion of Food Employee, or Summary 

Suspension of Permit. 

See discussion in Annex 3, § 2-201.12.
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Annex 4. Management of Food Safety Practices - Achieving Active Managerial Control

of Foodborne Illness Risk Factors

Annex 4 - 1

Annex 4 Management of Food 

Safety Practices – Achieving 

Active Managerial Control of 

Foodborne Illness Risk Factors

1. Active Managerial Control

2. Introduction to HACCP

3. The HACCP Principles

4. The Process Approach – A Practical Application of HACCP at Retail to 

Achieve Active Managerial Control

5. FDA Retail HACCP Manuals

6. Advantages of Using the Principles of HACCP

7. Summary

8. Acknowledgments

9. Resources and References

1. Active Managerial Control

A. What is the common goal of operators and regulators of retail food and food 

service establishments and what is presently being done to achieve this goal?

The common goal of operators and regulators of retail and food service establishments 

is to produce safe, quality food for consumers. Since the onset of regulatory oversight of 

retail and food service operations, regulatory inspections have emphasized the 

recognition and correction of food safety violations that exist at the time of the 

inspection. Recurring violations have traditionally been handled through re-inspections 

or enforcement activities such as fines, suspension of permits, or closures. Operators of 

retail and food service establishments routinely respond to inspection findings by 

correcting violations, but often do not implement proactive systems of control to prevent 

violations from recurring. While this type of inspection and enforcement system has 

done a great deal to improve basic sanitation and to upgrade facilities in the United 

States, it emphasizes reactive rather than preventive measures to food safety.

Additional measures must be taken on the part of operators and regulators to better 

prevent or reduce foodborne illness. Annex 5 of the Food Code provides additional 

information on conducting risk-based inspections. It should be reviewed in conjunction 

with the material found in this Annex to better understand the role of the regulator in 

facilitating active managerial control by the operator.
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of Foodborne Illness Risk Factors

Annex 4 - 2

B. Who has the ultimate responsibility for providing safe food to the consumer?

The responsibility of providing safe food to the consumer is shared by many people in 

every stage in the production of food, including consumers, themselves. Since most 

consumers receive their food from retail and food service establishments, a significant 

share of the responsibility for providing safe food to the consumer rests with these 

facilities. Working together with their regulatory authorities, operators of retail and food 

service establishments can make the greatest impact on food safety. 

C. How can foodborne illness be reduced?

The Centers for Disease Control and Prevention (CDC) Surveillance Report for 1993-

1997, “Surveillance for Foodborne-Disease Outbreaks – United States,” identifies the 

most significant contributing factors to foodborne illness. Five of these broad categories 

of contributing factors directly relate to food safety concerns within retail and food 

service establishments and are collectively termed by the FDA as “foodborne illness risk 

factors.” These five broad categories are:

• Food from Unsafe Sources

• Inadequate Cooking

• Improper Holding Temperatures

• Contaminated Equipment

• Poor Personal Hygiene

In 1998, FDA initiated a project designed to determine the incidence of foodborne 

illness risk factors in retail and food service establishments. Inspections focusing on the 

occurrence of foodborne illness risk factors were conducted in establishments 

throughout the United States. The results of this project are published in the 2000 

Report of the FDA Retail Food Program Database of Foodborne Illness Risk Factors, 

commonly referred to as the “FDA Baseline Report.” The Baseline Report is available at 

https://www.fda.gov/food/guidanceregulation/retailfoodprotection/foodborneillnessriskfac

torreduction/default.htm.

The data collection project was repeated in 2003 and the results are published in the 

FDA Report on the Occurrence of Foodborne Illness Risk Factors in Selected 

Institutional Foodservice, Restaurant, and Retail Food Store Facility Types (2004). This 

second report is available from FDA through the following website:

https://www.fda.gov/food/guidanceregulation/retailfoodprotection/foodborneillnessriskfac

torreduction/default.htm.

The data collection was repeated again in 2008 and published in a 2009 report This was 

followed by a Trend Analysis Report covering 1998-2008 that was published in October 

2010. The CDC Surveillance Report and the results from the FDA Risk Factor Studies 

support the concept that operators of retail and food service establishments must be 

proactive and implement food safety management systems that will prevent, eliminate,

or reduce the occurrence of foodborne illness risk factors. By reducing the occurrence 

of foodborne illness risk factors, foodborne illness can also be reduced.
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of Foodborne Illness Risk Factors

Annex 4 - 3

D. How can the occurrence of foodborne illness risk factors be reduced?

To effectively reduce the occurrence of foodborne illness risk factors, operators of retail 

and food service establishments must focus their efforts on achieving active managerial 

control. The term “active managerial control” is used to describe industry’s responsibility 

for developing and implementing food safety management systems to prevent, 

eliminate, or reduce the occurrence of foodborne illness risk factors.

Active managerial control means the purposeful incorporation of specific actions or 

procedures by industry management into the operation of their business to attain control 

over foodborne illness risk factors. It embodies a preventive rather than reactive 

approach to food safety through a continuous system of monitoring and verification.

There are many tools that can be used by industry to provide active managerial control 

of foodborne illness risk factors. Regulatory inspections and follow-up activities must 

also be proactive by using an inspection process designed to assess the degree of 

active managerial control that retail and food service operators have over the foodborne 

illness risk factors. In addition, regulators must assist operators in developing and 

implementing voluntary strategies to strengthen existing industry systems to prevent the 

occurrence of foodborne illness risk factors. Elements of an effective food safety 

management system may include the following:

• Certified food protection managers who have shown a proficiency in required 

information by passing a test that is part of an accredited program

• Standard operating procedures (SOPs) for performing critical operational 

steps in a food preparation process, such as cooling

• Recipe cards that contain the specific steps for preparing a food item and the 

food safety critical limits, such as final cooking temperatures, that need to be 

monitored and verified

• Purchase specifications

• Equipment and facility design and maintenance

• Monitoring procedures

• Record keeping 

• Employee health policy for restricting or excluding ill employees

• Manager and employee training

• On-going quality control and assurance

• Specific goal-oriented plans, like Risk Control Plans (RCPs), that outline 

procedures for controlling foodborne illness risk factors

A food safety management system based on Hazard Analysis and Critical Control Point 

(HACCP) principles contains many of these elements and provides a comprehensive 

framework by which an operator can effectively control the occurrence of foodborne 

illness risk factors.
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of Foodborne Illness Risk Factors

Annex 4 - 4

2. Introduction to HACCP

A. What is HACCP and how can it be used by operators and regulators of retail 

food and food service establishments? 

Hazard Analysis and Critical Control Point (HACCP) is a systematic approach to 

identifying, evaluating, and controlling food safety hazards. Food safety hazards are

biological, chemical, or physical agents that are reasonably likely to cause illness or

injury in the absence of their control. Because a HACCP program is designed to ensure 

that hazards are prevented, eliminated, or reduced to an acceptable level before a food 

reaches the consumer, it embodies the preventive nature of “active managerial control.” 

Active managerial control through the use of HACCP principles is achieved by 

identifying the food safety hazards attributed to products, determining the necessary 

steps that will control the identified hazards, and implementing on-going practices or 

procedures that will ensure safe food.

Like many other quality assurance programs, HACCP provides a common-sense 

approach to identifying and controlling problems that are likely to exist in an operation. 

Consequently, many food safety management systems at the retail level already 

incorporate some, if not all, of the principles of HACCP. Combined with good basic 

sanitation, a solid employee training program, and other prerequisite programs, a food 

safety management system based on HACCP principles will prevent, eliminate, or 

reduce the occurrence of foodborne illness risk factors that lead to out-of-control 

hazards.

HACCP represents an important tool in food protection that small independent 

businesses as well as national companies can use to achieve active managerial control 

of risk factors. The Food Code requires a comprehensive HACCP plan when conducting 

certain specialized processes at retail such as when a variance is granted or when a 

reduced oxygen packaging method is used. However, in general, the implementation of 

HACCP at the retail level is voluntary. FDA endorses the voluntary implementation of 

food safety management systems based on HACCP principles as an effective means 

for controlling the occurrence of foodborne illness risk factors that result in out-of-control 

hazards.

While the operator is responsible for developing and implementing a system of controls 

to prevent foodborne illness risk factors, the role of the regulator is to assess whether 

the system the operator has in place is achieving control of foodborne illness risk 

factors. Using HACCP principles during inspections will enhance the effectiveness of 

routine inspections by incorporating a risk-based approach. This helps inspectors focus 

their inspection on evaluating the effectiveness of food safety management systems 

implemented by industry to control foodborne illness risk factors.

The principles of HACCP are also an integral part of the draft FDA’s Recommended 

Voluntary National Retail Food Regulatory Program Standards. For regulatory program 

managers, the use of risk-based inspection methodology based on HACCP principles is 

a viable and practical option for evaluating the degree of active managerial control 
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Annex 4. Management of Food Safety Practices - Achieving Active Managerial Control

of Foodborne Illness Risk Factors

Annex 4 - 5

operators have over the foodborne illness risk factors. The complete set of Program 

Standards is available from FDA through the following website: 

http://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/ProgramStandards/

default.htm.

B. What are the Seven HACCP Principles?

In November 1992, the National Advisory Committee on Microbiological Criteria for 

Foods (NACMCF) defined seven widely accepted HACCP principles that explained the 

HACCP process in great detail. In 1997, NACMCF reconvened to review the 1992 

document and compare it to current HACCP guidance prepared by the CODEX 

Committee on Food Hygiene. Based on this review, NACMCF again endorsed HACCP 

and defined HACCP as a systematic approach to the identification, evaluation, and 

control of food safety. Based on a solid foundation of prerequisite programs to control 

basic operational and sanitation conditions, the following seven basic principles are 

used to accomplish this objective:

• Principle 1: Conduct a hazard analysis

• Principle 2: Determine the critical control points (CCPs)

• Principle 3: Establish critical limits

• Principle 4: Establish monitoring procedures

• Principle 5: Establish corrective actions

• Principle 6: Establish verification procedures

• Principle 7: Establish record-keeping and documentation procedures

This Annex will provide a brief overview of each of the seven principles of HACCP. A 

more comprehensive discussion of these principles is available from FDA by accessing 

the NACMCF guidance document on the FDA Web Page at: 

http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformati

on/Juice/ucm072557.htm. Following the overview, a practical scheme for applying and 

implementing the HACCP principles in retail and food service establishments is 

presented.

C. What are Prerequisite Programs? 

In order for a HACCP system to be effective, a strong foundation of procedures that 

address the basic operational and sanitation conditions within an operation must first be 

developed and implemented. These procedures are collectively termed “prerequisite 

programs.” When prerequisite programs are in place, more attention can be given to 

controlling hazards associated with the food and its preparation. Prerequisite programs 

may include such things as:

• Vendor certification programs

• Training programs

• Allergen management

• Buyer specifications

• Recipe/process instructions
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Annex 4 - 6

• First-In-First-Out (FIFO) procedures

• Other Standard Operating Procedures (SOPs)

• Basic prerequisite programs should be in place to:

• Protect products from contamination by biological, chemical, and physical food 

safety hazards

• Control bacterial growth that can result from temperature abuse

• Maintain equipment.

Additional information about prerequisite programs and the types of activities usually 

included in them can be found in the FDA’s Retail HACCP manuals discussed later in 

this Annex or by accessing the NACMCF guidance document on the FDA Web Page.

3. The HACCP Principles

A. Principle #1: Conduct a Hazard Analysis

What is a food safety hazard?

A hazard is a biological, chemical, or physical property that may cause a food to be 

unsafe for human consumption.

What are biological hazards?

Biological hazards include bacterial, viral, and parasitic microorganisms. See Table 

1 in this Annex for a listing of selected biological hazards. Bacterial pathogens 

comprise the majority of confirmed foodborne disease outbreaks and cases.

Although cooking destroys the vegetative cells of foodborne bacteria to acceptable 

levels, spores of spore-forming bacteria such as Bacillus cereus, Clostridium 

botulinum, and Clostridium perfringens survive cooking and may germinate and 

grow if food is not properly cooled or held after cooking. The toxins produced by the 

vegetative cells of Bacillus cereus, Clostridium botulinum, and Staphylococcus 

aureus may not be destroyed to safe levels by reheating. Post-cook recontamination 

with vegetative cells of bacteria such as Salmonellae and Campylobacter jejuni is 

also a major concern for operators of retail and food service establishments.

Viruses such as norovirus, hepatitis A, and rotavirus are directly related to 

contamination from human feces. Recent outbreaks have also shown that these 

viruses may be transmitted via droplets in the air. In limited cases, foodborne viruses 

may occur in raw commodities contaminated by human feces (e.g., shellfish 

harvested from unapproved, polluted waters). In most cases, however, 

contamination of food by viruses is the result of cross-contamination by ill food 

employees or unclean equipment and utensils. Unlike bacteria, a virus cannot 

multiply outside of a living cell. Cooking as a control for viruses may be ineffective 

because many foodborne viruses seem to exhibit heat resistance exceeding cooking 

temperature requirements, under laboratory conditions. Obtaining food from 

approved sources, practicing no bare hand contact with ready-to-eat food as well as 
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proper handwashing, and implementing an employee health policy to restrict or 

exclude ill employees are important control measures for viruses.

Parasites are most often animal host-specific, but can include humans in their life 

cycles. Parasitic infections are commonly associated with undercooking meat 

products or cross-contamination of ready-to-eat food with raw animal foods, 

untreated water, or contaminated equipment or utensils. Like viruses, parasites do 

not grow in food, so control is focused on destroying the parasites and/or preventing 

their introduction. Adequate cooking destroys parasites. In addition, parasites in fish 

to be consumed raw or undercooked can also be destroyed by effective freezing 

techniques. Parasitic contamination by ill employees can be prevented by proper 

handwashing, no bare hand contact with ready-to-eat food, and implementation of 

an employee health policy to restrict or exclude ill employees. 

Annex 4, Tables 1a – 1c. Selected Biological Hazards Found at Retail, Associated 

Foods, and Control Measures

Annex 4, Table 1a. Selected Bacterial Hazards Found at Retail,

Associated Foods, and Control Measures

HAZARD ASSOCIATED FOODS CONTROL MEASURES

Bacillus cereus

(intoxication caused by heat 

stable, preformed emetic 

toxin and infection by heat 

labile, diarrheal toxin)

Meat, poultry, starchy foods 

(rice, potatoes), puddings, 

soups, cooked vegetables

Cooking, cooling, cold 

holding, hot holding

Campylobacter jejuni Poultry, raw milk Cooking, handwashing, 

prevention of crosscontamination 
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HAZARD ASSOCIATED FOODS CONTROL MEASURES

Clostridium botulinum Vacuum-packed foods, 

reduced oxygen packaged 

foods, under-processed 

canned foods, garlic-in-oil 

mixtures, time/temperature 

abused baked 

potatoes/sautéed onions

Thermal processing (time + 

pressure), cooling, cold 

holding, hot holding, 

acidification and drying, etc.

Clostridium perfringens Cooked meat and poultry, 

Cooked meat and poultry 

products including 

casseroles, gravies

Cooling, cold holding, 

reheating, hot holding

E. coli O157:H7 (other 

shiga toxin-producing E. 

coli)

Raw ground beef, raw 

seed sprouts, raw milk, 

unpasteurized juice, foods 

contaminated by infected 

food workers via fecal-oral 

route

Cooking, no bare hand 

contact with RTE foods, 

employee health policy, 

handwashing, prevention 

of cross-contamination, 

pasteurization or treatment 

of juice

Hazard Associated Foods Control Measures

Listeria monocytogenes Raw meat and poultry, 

fresh soft cheese, paté, 

smoked seafood, deli 

meats, deli salads

Cooking, date marking, 

cold holding, 

handwashing, prevention 

of cross-contamination

Salmonella spp. Meat and poultry, seafood, 

eggs, raw seed sprouts, 

raw vegetables, raw milk, 

unpasteurized juice

Cooking, use of 

pasteurized eggs, 

employee health policy, no 

bare hand contact with 

RTE foods, handwashing, 

pasteurization or treatment 

of juice
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Hazard Associated Foods Control Measures

Shigella spp. Raw vegetables and 

herbs, other foods 

contaminated by infected 

workers via fecal-oral route

Cooking, no bare hand 

contact with RTE foods, 

employee health policy, 

handwashing

Staphylococcus aureus

(preformed heat stable 

toxin)

RTE TCS foods touched 

by bare hands after 

cooking and further 

time/temperature abused

Cooling, cold holding, hot 

holding, no bare hand 

contact with RTE food, 

handwashing

Vibrio spp. Seafood, shellfish Cooking, approved source, 

prevention of crosscontamination, cold 

holding

RTE = ready-to-eat TCS = time/temperature control for safety food

Annex 4, Table 1b. Selected Parasitic Hazards Found at Retail,

Associated Foods, and Control Measures

HAZARD ASSOCIATED FOODS CONTROL MEASURES

Anisakis simplex Various fish (cod, haddock, 

fluke, pacific salmon, herring, 

flounder, monkfish)

Cooking, freezing

Taenia spp. Beef and pork Cooking

Trichinella spiralis Pork, bear, and seal meat Cooking

RTE = ready-to-eat TCS = time/temperature control for safety food
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Annex 4, Table 1c. Selected Viral Hazards Found at Retail,

Associated Foods, and Control Measures

HAZARD ASSOCIATED FOODS CONTROL MEASURES

Hepatitis A and E Shellfish, any food contaminated 

by infected worker via fecal-oral 

route

Approved source, no bare 

hand contact with RTE food, 

minimizing bare hand 

contact with foods not RTE, 

employee health policy, 

handwashing

Other Viruses 

(Rotavirus, Norovirus, 

Reovirus)

Any food contaminated by 

infected worker via fecal-oral 

route

No bare hand contact with 

RTE food, minimizing 

bare hand contact with 

foods not RTE, employee 

health policy, 

handwashing

RTE = ready-to-eat TCS = time/temperature control for safety food

What are Chemical Hazards?

Chemical hazards may be naturally occurring or may be added during the 

processing of food. High levels of toxic chemicals may cause acute cases of 

foodborne illness, while chronic illness may result from low levels.

The Code of Federal Regulations (http://www.access.gpo.gov/nara/cfr/cfr-tablesearch.html), Title 21 Food and Drugs, provides guidance on naturally occurring 

poisonous or deleterious substances, e.g., 21 CFR Parts 109 Unavoidable 

Contaminants in Food for Human Consumption and Food Packaging Material, and 

184 Direct Food Substances Affirmed as Generally Recognized as Safe. The CFR 

also provide allowable limits for many of the chemicals added during processing, 

e.g., 21 CFR Part 172 Food Additives Permitted for Direct Addition to Food For 

Human Consumption.

FDA’s Compliance Policy Guidelines also provide information on naturally occurring

chemicals 

(http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/d

efault.htm ). See Chapter 5 – Foods, Colors and Cosmetics. Examples include 

sections:

• 540.600 Fish, Shellfish, Crustaceans, and Other Aquatic Animals – Fresh, 

Frozen or Processed – Methyl Mercury

• 555.400 Foods – Adulteration with Aflatoxin

• 570.200 Aflatoxin in Brazil Nuts, .375 Peanuts and Peanut Products, and .500 

Pistachio Nuts
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Table 2 of this Annex provides additional examples of chemical hazards, both 

naturally occurring and added. 

Food Allergens As Food Safety Hazards

Recent studies indicate that over 11 million Americans suffer from one or more food 

allergies. A food allergy is caused by a naturally-occurring protein in a food or a food 

ingredient, which is referred to as an “allergen.” For unknown reasons, certain 

individuals produce immunoglobulin E (IgE) antibodies specifically directed to food 

allergens. When these sensitive individuals ingest sufficient concentrations of foods 

containing these allergens, the allergenic proteins interact with IgE antibodies and 

elicit an abnormal immune response. A food allergic response is commonly 

characterized by hives or other itchy rashes, nausea, abdominal pain, vomiting 

and/or diarrhea, wheezing, shortness of breath, and swelling of various parts of the 

body. In severe cases, anaphylactic shock and death may result. 

Many foods, with or without identifiable allergens, have been reported to cause food 

allergies. However, FDA believes there is scientific consensus that the following 

foods can cause a serious allergic reaction in sensitive individuals; these foods 

account for 90% or more of all food allergies: 

• Milk 

• Egg

• Fish (such as bass, flounder, or cod)

• Crustacean shellfish (such as crab, lobster, or shrimp)

• Tree nuts (such as almonds, pecans, or walnuts)

• Wheat

• Peanuts

• Soybeans

• Sesame 

Consumers with food allergies rely heavily on information contained on food labels 

to avoid food allergens. Each year, FDA receives reports from consumers who have 

experienced an adverse reaction following exposure to a food allergen. Frequently, 

these reactions occur either because product labeling does not inform the consumer 

of the presence of the allergenic ingredient in the food or because of the crosscontact of a food with an allergenic substance not intended as an ingredient of the 

food during processing and preparation.

In August 2004, the Food Allergen Labeling and Consumer Protection Act (Public 

Law 108-282, Title II) was enacted, which defines the term “major food allergen.” 

The following requirements are included in the new law:

• For foods labeled on or after January 1, 2006, food manufacturers must 

identify in plain language on the label of the food any major food allergen 

used as an ingredient in the food, including a coloring, flavoring, or incidental 

additive.
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• FDA is to conduct inspections to ensure that food facilities comply with 

practices to reduce or eliminate cross-contact of a food with any major food 

allergens that are not intentional ingredients of the food.

• Within 18 months of the date of enactment of the new law (i.e., by February 2, 

2006), FDA must submit a report to Congress that analyzes the results of its 

food inspection findings and addresses a number of specific issues related to 

the production, labeling, and recall of foods that contain an undeclared major 

food allergen. 

• Within 2 years of the date of enactment of the new law (i.e., by August 2, 

2006), FDA must issue a proposed rule, and within 4 years of the date of 

enactment of the new law (i.e., by August 2, 2008), FDA must issue a final 

rule to define and permit the use of the term “gluten-free” on food labeling.

• FDA is to work in cooperation with the Conference for Food Protection (CFP) 

to pursue revision of the Food Code to provide guidelines for preparing 

allergen-free foods in food establishments.

In April 2021, the Food Allergy Safety, Treatment, Education, and Research Act of 

2021 (FASTER Act) amended section 201(qq) of the FD&C Act to add sesame to 

the definition of “major food allergen.” This amendment applies to “any food that is 

introduced or delivered for introduction into interstate commerce on or after January 

1, 2023 (Public Law 117-11). The definition of “major food allergen” adopted for use 

in the Food Code (see paragraph 1-201.10(B)) is consistent with the amendment to 

the FD&C Act in the new law. The following requirements are included in the new 

law:

• For any foods that are introduced or delivered for introduction into interstate 

commerce on or after January 1, 2023, food manufacturers must additionally 

identify in plain language on the label of the food any major food allergen used as 

an ingredient in the food, including a coloring, flavoring, or incidental additive. 

• Within 18 months of the date of enactment of the new law, FDA must submit a 

report to the Committee of Health, Education, Labor, and Pensions of the Senate 

and the Committee on Energy and Commerce of the House of Representatives a 

report that describes ongoing Federal activities and specific recommendations 

and strategies to expand, enhance, or improve ongoing Federal activities.
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Annex 4, Tables 2a-b. Common Chemical Hazards at Retail, Along with Their 

Associated Foods and Control Measures

Annex 4, Table 2a. Naturally Occurring Chemical Hazards at Retail, 

Along with Their Associated Foods and Control Measures

Naturally Occurring 

Chemical Hazards Associated Foods Control Measures

Allergens Foods containing or 

contacted by: 

• Milk

• Egg

• Fish

• Crustacean shellfish

• Tree nuts

• Wheat

• Peanuts

• Soybeans

• Sesame

Use a rigorous sanitation 

regime to prevent cross contact 

between allergenic and nonallergenic ingredients.

Ciguatoxin Reef fin fish from extreme 

SE US, Hawaii, and 

tropical areas; barracuda, 

jacks, king mackerel, 

large groupers, and 

snappers

Ensure fin fish have not been 

caught:

• Purchase fish from approved 

sources.

• Fish should not be harvested 

from an area that is subject to 

an adverse advisory.

Mycotoxins:

1. Aflatoxin

Corn and corn products, 

peanuts and peanut 

products, cottonseed, 

milk, and tree nuts such 

as Brazil nuts, pecans, 

pistachio nuts, and 

walnuts. Other grains and 

nuts are susceptible but 

less prone to 

contamination.

Check condition at receiving; 

do not use moldy or 

decomposed food.
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Naturally Occurring 

Chemical Hazards Associated Foods Control Measures

Mycotoxins:

2. Patulin

Apple juice products Buyer Specification: obtain 

verification from supplier or 

avoid the use of rotten apples 

in juice manufacturing

Phtyohaemmagglutinin Raw red kidney beans 

(Undercooked beans may 

be more toxic than raw 

beans)

1. Soak in water for at least 5 

hours.

2. Pour away the water.

3. Boil briskly in fresh water, 

with occasional stirring, for 

at least 10 minutes.

Pyrrolizidine alkaloids Plants food containing 

these alkaloids. Most 

commonly found in 

members of the 

Borginaceae, 

Compositae, and 

Leguminosae families.

Do consume of food or not 

medicinals contaminated with 

these alkaloids.

Scombrotoxin Primarily associated with 

tuna fish, mahi-mahi, blue 

fish, anchovies bonito, 

mackerel; Also found in 

cheese

Check temperatures at 

receiving; store at proper cold 

holding temperatures; buyer 

specifications: obtain 

verification from supplier that 

product has not been 

temperature abused prior to 

arrival in facility.

Shellfish toxins:

1. Paralytic shellfish 

poisoning (PSP)

Molluscan shellfish from 

NE and NW coastal 

regions; mackerel, 

viscera of lobsters and 

Dungeness, tanner, and 

red rock crabs

Ensure molluscan shellfish are:

• From an approved source; and 

Properly tagged and labeled
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Naturally Occurring 

Chemical Hazards Associated Foods Control Measures

Shellfish toxins:

2. Diarrhetic shellfish 

poisoning (DSP)

Molluscan shellfish in 

Japan, western Europe, 

Chile, NZ, eastern 

Canada

Ensure molluscan shellfish are:

• From an approved source; and 

• Properly tagged and labeled

Shellfish toxins:

3. Neurotoxin 

shellfish poisoning 

(NSP)

Molluscan shellfish from 

Gulf of Mexico

Ensure molluscan shellfish are:

• From an approved source; and 

• Properly tagged and labeled

Shellfish toxins:

4. Amnesic shellfish 

poisoning (ASP)

Molluscan shellfish from 

NE and NW coasts of 

NA; viscera of 

Dungeness, tanner, red 

rock crabs and 

anchovies.

Ensure molluscan shellfish are:

• From an approved source; and 

• Properly tagged and labeled

Tetrodotoxin Puffer fish (Fugu; 

Blowfish)

Do not consume these fish.

Toxic mushroom 

species

Numerous varieties of 

wild mushrooms

Do not eat unknown varieties 

or mushrooms from 

unapproved source. 
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Annex 4, Table 2b. Added Chemical Hazards at Retail, Along with Their 

Associated Foods and Control Measures

Added Chemical 

Hazards Associated Foods Control Measures

Chemicals used in retail 

establishments (e.g., 

lubricants, cleaners, 

sanitizers, cleaning 

compounds, and paints

Any food could become 

contaminated

• Address through SOPs for 

proper labeling, storage, 

handling, and use of 

chemicals.

• Retain Material Safety Data 

Sheets (MSDS) for all 

chemicals.

Environmental 

contaminants:

Pesticides, fungicides, 

fertilizers, insecticides, 

antibiotics, growth 

hormones

Any food may become 

contaminated.

• Follow label instructions for 

use of environmental 

chemicals.

• Soil or water analysis may 

be used to verify safety.

Nitrites/nitrates

Niacin

• Cured meats, fish, any 

food exposed to 

accidental 

contamination, spinach.

• Meat and other foods 

to which sodium 

nicotinate is added

• Do not use more than the 

prescribed amount of curing 

compound according to

labeling instructions.

• Sodium nicotinate (niacin) is 

not currently approved for 

use in meat or poultry with 

or without nitrates or 

nitrates.

PCBs Fish Comply with fish advisories.

Preservatives and Food 

Additives:

Sulfiting agents 

(sulfur dioxide, 

sodium and 

potassium bisulfite, 

sodium and 

potassium 

metabisulfite)

• Fresh fruits and 

Vegetables

• Shrimp

• Lobster

• Wine

• Sulfiting agents added to a 

product in a processing 

plant must be declared on 

labeling.

• Do not use on raw produce 

in food establishments.
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Added Chemical 

Hazards Associated Foods Control Measures

Prohibited substances 

(21 CFR 189)

• Numerous substances 

are prohibited from use 

in human food.

• No substance may be 

used in human food 

unless it meets all 

applicable 

requirements of the 

FD&C Act.

Do not use chemical 

substances that are not 

approved for use in human 

food.

Toxic elements/

compounds:

1. Copper 

High acid foods and 

beverages

• Do not store high acid foods 

in copper utensils.

• Use backflow prevention 

device on beverage vending 

machines.

Toxic elements/

compounds:

2. Lead

High acid food and 

beverages

Do not use vessels containing 

lead. 

Toxic elements/

compounds:

3. Mercury

• Fish exposed to 

organic mercury: shark, 

tilefish, king mackerel 

and swordfish.

• Grains treated with 

mercury based 

fungicides.

• Pregnant women/women of 

childbearing age/nursing 

mothers, and young children 

should not eat shark, 

swordfish, king mackerel or 

tilefish because they contain 

high levels of mercury.

• Do not use mercury 

containing fungicides on 

grains or animals.

5. What are Physical Hazards?

Illness and injury can result from foreign objects in food. These physical hazards can 

result from contamination or poor procedures at many points in the food chain from 

harvest to consumer, including those within the food establishment. As establishments 

develop their food safety management systems, Annex 4, Table 3 can be used to aid in 

the identification of sources of potential physical hazards to the food being prepared, 

served, or sold. Annex 4, Table 3 provides some examples of common physical 

hazards.
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Annex 4, Table 3. Main Materials of Concern as Physical Hazards

and Common Sourcesa, b

Material Injury Potential Sources

Glass fixtures Cuts, bleeding; may 

require surgery to find or 

remove

Bottles, jars, lights, 

utensils, gauge covers

Wood Cuts, infection, choking; 

may require surgery to 

remove 

Fields, pallets, boxes, 

buildings

Stones, metal fragments Choking, broken teeth

Cuts, infection; may 

require surgery to remove

Fields, buildings, 

machinery, wire, 

employees

Insulation Choking; long-term if 

asbestos

Building materials

Bone Choking, trauma Fields, improper plant 

processing

Plastic Choking, cuts, infection; 

may require surgery to 

remove

Fields, plant packaging 

materials, pallets, 

employees

Personal effects Choking, cuts, broken 

teeth; may require 

surgery to remove

Employees 

a Adapted from Corlett (1991).

b Used with permission, "HACCP Principles and Applications", Pierson and Corlett, Eds. 

1992. Chapman & Hall, New York, NY.

6. What is the purpose of the hazard analysis principle?

The purpose of hazard analysis is to develop a list of food safety hazards that are 

reasonably likely to cause illness or injury if not effectively controlled.

7. How is the hazard analysis conducted?

The process of conducting a hazard analysis involves two stages:

1. Hazard Identification

2. Hazard Evaluation
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Hazard identification can be thought of as a brain storming session. This stage 

focuses on identifying the food safety hazards that might be present in the food 

given the food preparation process used, the handling of the food, the facility, and 

general characteristics of the food itself. During this stage, a review is made of the 

ingredients used in the product, the activities conducted at each step in the process, 

the equipment used, the final product, and its method of storage and distribution, as 

well as the intended use and consumers of the product.

Based on this review, a list of potential biological, chemical, or physical hazards is 

made at each stage in the food preparation process.

In stage two, the hazard evaluation, each potential hazard is evaluated based on the 

severity of the potential hazard and its likely occurrence. The purpose of this stage is 

to determine which of the potential hazards listed in stage one of the hazard analysis 

warrant control in the HACCP plan. Severity is the seriousness of the consequences 

of exposure to the hazard. Considerations made when determining the severity of a 

hazard include understanding the impact of the medical condition caused by the 

illness, as well as the magnitude and duration of the illness or injury. Consideration 

of the likely occurrence is usually based upon a combination of experience, 

epidemiological data, and information in the technical literature. Hazards that are not 

reasonably likely to occur are not considered in a HACCP plan. During the 

evaluation of each potential hazard, the food, its method of preparation, 

transportation, storage, and persons likely to consume the product should be 

considered to determine how each of these factors may influence the likely 

occurrence and severity of the hazard being controlled.

Upon completion of the hazard analysis, a list of significant hazards that must be 

considered in the HACCP plan is made, along with any measure(s) that can be used 

to control the hazards. These measures, called control measures, are actions or 

activities that can be used to prevent, eliminate, or reduce a hazard. Some control 

measures are not essential to food safety, while others are. Control measures 

essential to food safety like proper cooking, cooling, and refrigeration of ready-toeat, time/temperature control for safety foods are usually applied at critical control 

points (CCPs) in the HACCP plan (discussed later). The term control measure is 

used because not all hazards can be prevented, but virtually all can be controlled. 

More than one control measure may be required for a specific hazard. Likewise, 

more than one hazard may be addressed by a specific control measure (e.g., proper 

cooking).

B. Principle #2: Determine Critical Control Points (CCPs)

What is the Critical Control Point (CCP)?

A critical control point (CCP) means a point or procedure in a specific food system 

where loss of control may result in an unacceptable health risk. Control can be 

applied at this point and is essential to prevent or eliminate a food safety hazard or 

reduce it to an acceptable level. Each CCP will have one or more control measures 
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to assure that the identified hazards are prevented, eliminated, or reduced to 

acceptable levels. Common examples of CCPs include cooking, cooling, hot holding, 

and cold holding of ready-to-eat time/temperature control for safety foods. Due to 

vegetative and spore- and toxin-forming bacteria that are associated with raw animal 

foods, it is apparent that the proper execution of control measures at each of these 

operational steps is essential to prevent or eliminate food safety hazards or reduce 

them to acceptable levels.

Are quality issues considered when determining CCPs?

CCPs are only used to address issues with product safety. Actions taken on the part 

of the establishment such as first-in first-out (FIFO) or refrigerating nontime/temperature control for safety foods are to ensure food quality rather than food 

safety and therefore should not be considered as CCPs unless they serve a dualpurpose of ensuring food safety.

Are the CCPs the same for everyone?

Different facilities preparing similar food items may identify different hazards and the 

CCPs. This can be due to differences in each facility's layout, equipment, selection 

of ingredients, and processes employed. In mandatory HACCP systems, there may 

be rigid regulatory requirements regarding what must be designated a CCP. In 

voluntary HACCP systems, hazard control may be accomplished at CCPs or through 

prerequisite programs. For instance, one facility may decide that it can best manage 

the hazards associated with cooling through a standardized procedure in its 

prerequisite programs rather than at a CCP in its HACCP plan. One tool that can be 

used to assist each facility in the identification of CCPs unique to its operation is a 

CCP decision tree.
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Annex 4 – CCP Decision Tree 1

*Decision tree adapted from NACMCF
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C. Principle #3: Establish Critical Limits

What is a critical limit and what is its purpose?

A critical limit is a prescribed parameter (e.g., minimum and/or maximum value) that 

must be met to ensure that food safety hazards are controlled at each CCP. A 

critical limit is used to distinguish between safe and unsafe operating conditions at a 

CCP. Each control measure at a CCP has one or more associated critical limits.

Critical limits may be based upon factors like temperature, time, moisture level, 

water activity (aw), or pH. They must be scientifically-based and measurable.

What are examples of critical limits?

Examples of critical limits are the time/temperature parameters for cooking chicken 

(165oF for <1 second (instantaneous)). In this case, the critical limit designates the 

minimum criteria required to eliminate food safety hazards or reduce them to an 

acceptable level. The critical limit for the acidification of sushi rice, a pH of <4.2, sets 

the maximum limit for pH necessary to control the growth of spore- and toxin-forming 

bacteria. Critical limits may be derived from regulatory standards such as the FDA 

Food Code, other applicable guidelines, performance standards, or experimental 

results.

D. Principle #4: Establish Monitoring Procedures

What is the purpose of monitoring?

Monitoring is the act of observing and making measurements to help determine if 

critical limits are being met and maintained. It is used to determine whether the 

critical limits that have been established for each CCP are being met.

What are examples of monitoring activities?

Examples of monitoring activities include visual observations and measurements of 

time, temperature, pH, and water activity. If cooking chicken is determined to be a

CCP in an operation, then monitoring the internal temperature of a select number of 

chicken pieces immediately following the cook step would be an example of a 

monitoring activity. Alternatively, the temperature of an oven or fryer and the time 

required to reach an internal temperature of 165 oF could also be monitored.

How is monitoring conducted?

Typically, monitoring activities fall under two broad categories:

• Measurements

• Observations

Measurements usually involve time and temperature but also include other 

parameters such as pH. If an operation identifies the acidification of sushi rice as a 
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CCP and the critical limit as the final pH of the product being < 4.2, then the pH of 

the product would be measured to ensure that the critical limit is met.

Observations involve visual inspections to monitor the presence or absence of a 

food safety activity. If date marking is identified as a CCP in a deli operation for 

controlling Listeria monocytogenes in ready-to-eat deli meats, then the monitoring 

activity could involve making visual inspections of the date marking system to 

monitor the sell, consume, or discard dates. 

How often is monitoring conducted?

Monitoring can be performed on a continuous or intermittent basis. Continuous 

monitoring is always preferred when feasible as it provides the most complete 

information regarding the history of a product at a CCP. For example, the 

temperature and time for an institutional cook-chill operation can be recorded 

continuously on temperature recording charts.

If intermittent monitoring is used, the frequency of monitoring should be conducted 

often enough to make sure that the critical limits are being met.

Who conducts monitoring?

Individuals directly associated with the operation (e.g., the person in charge of the 

establishment, chefs, and departmental supervisors) are often selected to monitor 

CCPs. They are usually in the best position to detect deviations and take corrective 

actions when necessary. These employees should be properly trained in the specific 

monitoring techniques and procedures used.

E. Principle #5: Establish Corrective Actions

What are corrective actions?

Corrective actions are activities that are taken by a person whenever a critical limit is 

not met. Discarding food that may pose an unacceptable food safety risk to 

consumers 

is a corrective action. However, other corrective actions such as further cooking or 

reheating a product can be used provided food safety is not compromised. For 

example, a restaurant may be able to continue cooking hamburgers that have not 

reached an internal temperature of 155 oF for 17 seconds until the proper 

temperature is met. Clear instructions should be developed detailing who is 

responsible for performing the corrective actions, the procedures to be followed, and 

when.

F. Principle #6: Establish Verification Procedures

What is verification?
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Verification includes those activities, other than monitoring, that determine the 

validity of the HACCP plan and show that the system is operating according to the 

plan. Validation is a component of verification which focuses on collecting and 

evaluating scientific and technical information to determine if the HACCP system, 

when properly implemented, will effectively control the hazards. Clear instructions 

should be developed detailing who is responsible for conducting verification, the 

frequency of verification, and the procedures used.

What is the frequency of verification activities? What are some examples of 

verification activities?

Verification activities are conducted frequently, such as daily, weekly, monthly, and 

include the following:

• Observing the person doing the monitoring and determining whether 

monitoring is being done as planned

• Reviewing the monitoring records to determine if they are completed 

accurately and consistently

• Determining whether the records show that the frequency of monitoring stated 

in the plan is being followed

• Ensuring that corrective action was taken when the person monitoring found 

and recorded that the critical limit was not met

validating that the critical limits are achieving the desired results of controlling 

the identified hazard

• Confirming that all equipment, including equipment used for monitoring, is 

operated, maintained, and calibrated properly.

G. Principle #7: Establish Record Keeping Procedures

Why are records important?

Maintaining documentation of the activities in a food safety management system can 

be vital to its success. Records provide documentation that appropriate corrective 

actions were taken when critical limits were not met. In the event that an 

establishment is implicated in a foodborne illness, documentation of activities related 

to monitoring and corrective actions can provide proof that reasonable care was 

exercised in the operation of the establishment. Documenting activities provides a 

mechanism for verifying that the activities in the HACCP plan were properly 

completed. In many cases, records can serve a dual purpose of ensuring quality and 

food safety.

What types of records are maintained as part of a food safety management 

system?

There are at least five (5) types of records that could be maintained to support a 

food safety management system:
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• Records documenting the activities related to the prerequisite programs

• Monitoring records

• Corrective action records

• Verification and validation records

• Calibration records

4. The Process Approach – A Practical Application of HACCP at Retail to 

Achieve Active Managerial Control

A. Why Focus on HACCP Principles at Retail and Food Service? 

FDA recognizes that there are important differences between using HACCP principles 

in a food safety management system developed for food manufacturing plants and 

applying these same principles in food safety management system developed for use in 

retail and food service establishments.

Since the 1980’s, operators and regulators have been exploring the use of the HACCP 

principles in restaurants, grocery stores, institutional care facilities, and other retail food 

establishments. During this time, much has been learned about how these principles 

can be used in these varied operations, collectively referred to as retail food 

establishments. Most of this exploration has centered around the focal question of how 

to stay true to the NACMCF definitions of HACCP and still make the principles useful to 

an industry that encompasses the broadest range of conditions.

Unlike industries such as canning, other food processing, and dairy plants, the retail 

industry is not easily defined by specific commodities or conditions. Consider the 

following characteristics that retail food establishments share that set them apart from 

most food processors:

1. Employee and management turnover is exceptionally high in food 

establishments, especially for entry level positions. This means the many 

employees or managers have little experience and food safety training must be 

continuously provided.

2. Many establishments are start-up businesses operating without benefit of a large 

corporate support structure and having a relatively low profit margin and perhaps 

less capital to work with than other segments of the food industry.

3. There is an almost endless number of production techniques, products, menu 

items, and ingredients used which are not easily adapted to a simple, 

standardized approach. Changes occur frequently and little preparation time is 

available.

FDA fully recognizes the diversity of retail and food service establishments and their 

varying in-house resources to implement HACCP. That recognition is combined with an 

understanding that the success of such implementation is dependent upon establishing 

realistic and useful food safety strategies that are customized to the operation.
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B. What is the Process Approach?

When conducting the hazard analysis, food manufacturers usually use food 

commodities as an organizational tool and follow the flow of each product. This is a very 

useful approach for producers or processors since they are usually handling one 

product at a time. By contrast, in retail and food service operations, foods of all types 

are worked together to produce the final product. This makes a different approach to the 

hazard analysis necessary. Conducting the hazard analysis by using the food 

preparation processes common to a specific operation is often more efficient and useful 

for retail and food service operators. This is called the "process approach" to HACCP.

The process approach can best be described as dividing the many food flows in an 

establishment into broad categories based on activities or stages in the preparation of 

the food, then analyzing the hazards, and placing managerial controls on each 

grouping.

C. What are the three food preparation processes most often used in retail and 

food service establishments and how are they determined?

The flow of food in a retail or food service establishment is the path that food follows 

from receiving through service or sale to the consumer. Several activities or stages 

make up the flow of food and are called operational steps. 

Examples of operational steps include receiving, storing, preparing, cooking, cooling, 

reheating, holding, assembling, packaging, serving, and selling. The terminology used 

for operational steps may differ between food service and retail food store operations.

Most food items produced in a retail or food service establishment can be categorized 

into one of three preparation processes based on the number of times the food passes 

through the temperature danger zone between 41°F and 135°F:

• Process 1: Food Preparation with No Cook Step

Example flow: Receive → Store → Prepare → Hold → Serve

Other food flows are included in this process, but there is no cook step to destroy 

pathogens.

• Process 2: Preparation for Same Day Service

Example flow: Receive → Store → Prepare → Cook → Hold → Serve

Other food flows are included in this process, but there is only one trip through 

the temperature danger zone.

• Process 3: Complex Food Preparation

Example flow: Receive → Store → Prepare → Cook → Cool → Reheat →

Hot Hold → Serve
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Other food flows are included in this process, but there are always two or more 

complete trips through the temperature danger zone.

A summary of the three food preparation processes in terms of number of times through 

the temperature danger zone can be depicted in a Danger Zone diagram. Although 

foods produced using process 1 may enter the danger zone, they do not pass all the 

way through it. Foods that go through the danger zone only once are classified as Same 

Day Service, while foods that go through more than once are classified as Complex 

food preparation. 

The three food preparation processes conducted in retail and food service 

establishments are not intended to be all-inclusive. For instance, quick service facilities 

may have “cook and serve” processes specific to their operation. These processes are 

likely to be different from the “Same Day Service” preparation processes in full service 

restaurants since many of their foods are generally cooked and hot held before service. 

In addition, in retail food stores, operational steps such as packaging and assembly may 

be included in all of the food preparation processes before the product is sold to the 

consumer. It is also very common for a retail or food service operator to use multiple 

food preparation processes to create a single menu item.

D. How is a hazard analysis conducted in process HACCP? 

In the process approach to HACCP, conducting a hazard analysis on individual food 

items is time and labor intensive and is generally unnecessary. Identifying and 

0

Complete Trips Through the Danger Zone

No Cook Same Day Complex

41°F

135°F

1 1

2

3
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controlling the hazards in each food preparation process achieves the same control of 

risk factors as preparing a HACCP plan for each individual product.

Example: An establishment has dozens of food items (including baked chicken and 

baked meatloaf) in the “Preparation for Same Day Service” category. Each of the food 

items may have unique hazards, but regardless of the individual hazards, control via 

proper cooking and holding will generally ensure the safety of all of the foods in this 

category. An illustration of this concept follows:

• Even though they have unique hazards, baked chicken and meatloaf are items 

frequently grouped in the “Same Day Service” category (Process 2).

• Salmonella spp. and Campylobacter, as well as spore-formers, such as Bacillus 

cereus and Clostridium perfringens, are significant biological hazards in chicken.

• Significant biological hazards in meatloaf include Salmonella spp., E. coli

O157:H7, Bacillus cereus, and Clostridium perfringens.

• Despite their different hazards, the control measure used to kill pathogens in both 

these products is cooking to the proper temperature.

• Additionally, if the products are held after cooking, then proper hot holding or 

time control is also required to prevent the outgrowth of spore-formers that are 

not destroyed by cooking. 

As with product-specific HACCP, critical limits for cooking remain specific to each food 

item in the process. In the scenario described above, the cooking step for chicken 

requires a final internal temperature of 165°F to control the pathogen load for 

Salmonella spp. Meatloaf, on the other hand, is a ground beef product and requires a 

final internal temperature of 155°F for 17 seconds to control the pathogen load for both 

Salmonella spp. and E. coli O157:H7. Some operational steps such as refrigerated 

storage or hot holding have critical limits that apply to all foods.

Annex 4, Table 4 further illustrates this concept. Note that the only unique control 

measure applies to the critical limit of the cooking step for each of the products. Other 

food safety hazards and control measures may exist that are not depicted here.
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Annex 4, Table 4: Examples of Hazards and Control Measures for Same Day 

Service Items

Baked Meatloaf (Process 2: Preparation for Same Day Service)

Example Biological 

Hazards Example Control Measures

Salmonella spp. Refrigeration at 41oF or below

E. coli O157:H7 Cooking at 155oF for 17 seconds

Clostridium perfringens Hot Holding at 135oF or above OR Time Control 

Bacillus cereus Hot Holding at 135oF or above OR Time Control

Various fecal-oral route 

pathogens

Good personal hygiene (No bare hand contact with 

ready-to-eat food, proper handwashing, 

exclusion/restriction of ill employees)

Baked Chicken (Process 2: Preparation for Same Day Service)

Example Biological 

Hazards Example Control Measures

Salmonella spp. Refrigeration at 41oF or below

Campylobacter Cooking at 165oF or above

Clostridium perfringens Hot Holding at 135oF or above OR Time Control 

Bacillus cereus Hot Holding at 135oF or above OR Time Control

Various fecal-oral route 

pathogens

Good personal hygiene (No bare hand contact with 

ready-to-eat food, proper handwashing, 

exclusion/restriction of ill employees)
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E. How is the process approach helpful to industry in determining the measures 

that must be implemented to actively manage the foodborne illness risk 

factors that result in out-of-control hazards?

Even though variations in foods and in the three food preparation process flows used to 

prepare them are common, the control measures will generally be the same based on 

the number of times the food goes through the temperature danger zone. Several of the 

most common control measures associated with each food preparation process are 

discussed in this Annex. Retail or food service establishments should use these simple 

control measures as the core of their food safety management systems; however, there 

may be other risk factors unique to an operation or process that are not listed here.

Each operation should be evaluated independently.

In developing a voluntary food safety management system, active managerial control of 

risk factors common to each process can be achieved by implementing control 

measures at certain operational steps designated as critical control points (CCPs) or by 

implementing prerequisite programs. This is explained in more detail in the Operator’s 

Manual discussed in Part 5 of this Annex.

F. Facility-wide Considerations

In order to have active managerial control over personal hygiene and crosscontamination, certain control measures must be implemented in all phases of the 

operation. All of the following control measures should be implemented regardless of 

the food preparation process used:

• No bare hand contact with ready-to-eat foods (or use of a pre-approved, 

alternative procedure) to help prevent the transfer of viruses, bacteria, or 

parasites from hands to food

• Proper handwashing to help prevent the transfer of viruses, bacteria, or 

parasites from hands to food

• Restriction or exclusion of ill employees to help prevent the transfer of 

viruses, bacteria, or parasites from hands to food

• Prevention of cross-contamination of ready-to-eat food or clean and sanitized 

food-contact surfaces with soiled cutting boards, utensils, aprons, etc., or raw 

animal foods.

G. Food Preparation Process 1 – Food Preparation with No Cook Step

Example Flow: RECEIVE → STORE → PREPARE → HOLD → SERVE

Several food flows are represented by this particular process. Many of these food flows 

are common to both retail food stores and food service facilities, while others only apply 

to retail operations. Raw, ready-to-eat food like sashimi, raw oysters, and salads are 

grouped in this category. Components of these foods are received raw and will not be 

cooked before consumption.
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Foods cooked at the processing level but that undergo no further cooking at the retail 

level before being consumed are also represented in this category. Examples of these 

kinds of foods are deli meats, cheeses, and other pasteurized dairy products (such as 

yogurt). In addition, foods that are received and sold raw but are to be cooked by the 

consumer after purchase, e.g., hamburger meat, chicken, and steaks, are also included 

in this category. 

All the foods in this category lack a cook step while at the retail or food service facility; 

thus, there are no complete trips through the danger zone. Purchase specifications can 

be required by the retail or food service establishment to ensure that foods are received 

as safe as possible. Without a kill step to destroy pathogens, preventing further 

contamination by ensuring that employees follow good hygienic practices is an 

important control measure.

Cross-contamination must be prevented by properly storing ready-to-eat food away 

from raw animal foods and soiled equipment and utensils. Foodborne illness may result 

from ready-to-eat food being held at unsafe temperatures for long periods of time due to 

the outgrowth of bacteria.

In addition to the facility-wide considerations, a food safety management system 

involving this food preparation process should focus on ensuring active managerial 

control over the following:

• Cold holding or using time alone to control bacterial growth and toxin 

productionn

• Food source (e.g., shellfish due to concerns with viruses, natural toxins, and 

Vibrio and for certain marine finfish intended for raw consumption due to 

concerns with ciguatera toxin) 

• Receiving temperatures (e.g., certain species of marine finfish due to concerns 

with scombrotoxin) 

• Date marking of ready-to-eat TCS food held for more than 24 hours to control 

the growth of psychrophiles such as Listeria monocytogenes

• Freezing certain species of fish intended for raw consumption due to parasite 

concerns 

• Cooling from ambient temperature to prevent the outgrowth of spore-forming or 

toxin-forming bacteria.
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H. Food Preparation Process 2 – Preparation for Same Day Service

Example Flow: RECEIVE → STORE → PREPARE → COOK → HOLD → SERVE

In this food preparation process, food passes through the danger zone only once in the 

retail or food service facility before it is served or sold to the consumer. Food is usually 

cooked and held hot until served, e.g., fried chicken, but can also be cooked and served 

immediately. In addition to the facility-wide considerations, a food safety management 

system involving this food preparation process should focus on ensuring active 

managerial control over the following:

• Cooking to destroy bacteria and parasites

• Hot holding or using time alone to prevent the outgrowth of spore-forming 

bacteria.

Approved food source, proper receiving temperatures, and proper cold holding before

cooking would also be important if dealing with certain marine finfish due to concerns 

with ciguatera toxin and scombrotoxin.

I. Food Preparation Process 3 – Complex Food Preparation

Example Flow: RECEIVE → STORE → PREPARE → COOK → COOL → REHEAT →

HOT HOLD → SERVE

Foods prepared in large volumes or in advance for next day service usually follow an 

extended process flow. These foods pass through the temperature danger zone more 

than one time; thus, the potential for the growth of spore-forming or toxigenic bacteria is 

greater in this process. Failure to adequately control food product temperatures is one 

of the most frequently encountered risk factors contributing to foodborne illness. Food 

handlers should minimize the time foods are at unsafe temperatures.

In addition to the facility-wide considerations, a food safety management system 

involving this food preparation process should focus on ensuring active managerial 

control over the following:

• Cooking to destroy bacteria and parasites

• Cooling to prevent the outgrowth of spore-forming or toxin-forming bacteria

• Hot and cold holding or using time alone to control bacterial growth and toxin 

formation

• Date marking of ready-to-eat TCS food held for more than 24 hours to control 

the growth of psychrophiles such as Listeria monocytogenes

• Reheating for hot holding, if applicable.

Approved food source, proper receiving temperatures, and proper cold holding before

cooking would also be important if dealing with certain marine finfish due to concerns 

with ciguatera toxin and scombrotoxin.
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5. FDA Retail HACCP Manuals

A. What guidance has been developed by FDA to assist operators of retail and 

food service establishments in achieving active managerial control of 

foodborne illness risk factors?

FDA, in partnership with Federal, State, and local regulators, industry, academia, and 

consumers, has written a guidance document entitled, “Managing Food Safety: A 

Manual for the Voluntary Use of HACCP Principles for Operators of Food Service and 

Retail Establishments.” Commonly referred to as the “Operator’s Manual,” this 

document is designed to assist operators with developing or enhancing food safety 

management systems based on the process approach to HACCP. The manual presents 

a step-by-step procedure for writing and voluntarily implementing a food safety 

management system based on the principles of HACCP. The desired outcome is an 

operator who employs a preventive rather than a reactive strategy to food safety.

The Operator’s Manual embodies FDA’s current thinking on the application of HACCP 

principles at retail. It advocates the voluntary use of HACCP principles using the 

process approach as a practical and effective means of reducing the occurrence of 

foodborne illness risk factors leading to out-of-control hazards. The Operator’s Manual 

is strictly for the voluntary implementation of HACCP principles at retail and should not 

be used to develop HACCP plans that are required through Federal, State, or local 

regulations, ordinances, or laws. The document can be found on the FDA Web Page at 

http://www.fda.gov/Food/GuidanceRegulation/HACCP/ucm2006811.htm.

B. What guidance has been developed by FDA to assist regulators of retail and 

food service establishments in assessing industry’s active managerial control 

of foodborne illness risk factors? 

FDA has written a document for regulators of retail and food service establishments 

entitled, “Managing Food Safety: A Regulator’s Manual for Applying HACCP Principles 

to Risk-Based Retail and Food Service Inspections and Evaluating Voluntary Food 

Safety Management Systems.” Commonly referred to as the “Regulator’s Manual,” this 

document was written to provide a risk-based inspectional "roadmap" for evaluating the 

degree of active managerial control an operator has over foodborne illness risk factors.

In addition, the manual advocates the use of voluntary intervention strategies, including 

the development of food safety management systems or risk control plans to bring 

about a long-term behavior change that will result in a reduction in the occurrence of 

risk factors. In cases where an operator may want their inspector to provide them with 

feedback on their voluntarily-implemented food safety management system, the manual 

provides regulators with information on how to validate and verify an existing system.

The document can be found on the FDA Web Page at: 

http://www.fda.gov/Food/GuidanceRegulation/HACCP/ucm2006812.htm.

Annex 5 of the Food Code outlines the basis for conducting successful risk-based 

inspections and is provided to assist industry in achieving active managerial control of 
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foodborne illness risk factors as outlined in the draft Recommended National Retail 

Food Regulatory Program Standards and the Regulator’s Manual.

6. Advantages of Using the Principles of HACCP

A. What advantages does using HACCP principles offer operators of retail and 

food service establishments?

Rather than relying solely on periodic feedback from inspections by regulatory agencies, 

an establishment operator who implements a food safety management system based 

on HACCP principles emphasizes continuous problem solving and prevention.

Additionally, HACCP enhances and encourages communication between industry and 

regulators.

A food safety management system based on HACCP principles offers many other 

advantages to industry. One advantage is that such a system may provide a method for 

achieving active managerial control of multiple risk factors associated with an entire 

operation. Other advantages include:

• Reduction in product loss

• Increase in product quality

• Better inventory control

• Consistency in product preparation

• Increase in profit

• Increased employee awareness and participation in food safety.

B. What advantages does using HACCP principles offer regulators of retail and 

food service establishments?

Traditional inspections are relatively resource-intensive, inefficient, and reactive rather 

than preventive in nature. Using traditional inspection techniques allows for a 

satisfactory “snapshot” assessment of the requirements of the code at the time of the 

inspection. Unfortunately, unless an inspector asks questions and inquires about the 

activities and procedures being utilized by the establishment even at times when the 

inspector is not there, there is no way to know if an operator is achieving active

managerial control.

With the limited time often available for conducting inspections, regulators must focus 

their attention on those areas that clearly have the greatest impact on food safety –

foodborne illness risk factors. By knowing that there are only a few control measures 

that are essential to food safety and focusing on these during the inspection, an 

inspector can assess the operator’s active managerial control of the foodborne illness 

risk factors.

Regulators can provide invaluable feedback to an operator through their routine 

inspections. This is especially useful when utilizing a risk-based approach. By 

incorporating HACCP principles into routine inspections, an inspector can provide an 
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operator with the constructive input needed to establish the control system necessary to 

bring the foodborne illness risk factors back under continuous control. 

7. Summary

In order to make a positive impact on foodborne illness, retail and food service 

operators must achieve active managerial control of the risk factors contributing to 

foodborne illness. Combined with basic sanitation, employee training, and other 

prerequisite programs, the principles of HACCP provide an effective system for

achieving this objective.

The goal in applying HACCP principles in retail and food service is to have the operator 

take purposeful actions to ensure safe food. The process approach simplifies HACCP 

principles for use in retail and food service. This practical and effective method of 

hazard control embodies the concept of active managerial control by providing an ongoing system of simple control measures that will reduce the occurrence of risk factors 

that lead to out-of-control hazards.

The role of retail and food service regulatory professionals is to conduct risk-based 

inspections using HACCP principles to assess the degree of control industry has over 

the foodborne illness risk factors. Regulators can assist industry in achieving active 

managerial control of risk factors by using a risk-based inspection approach to identify 

strengths and weaknesses and suggesting possible solutions and improvements.

8. Acknowledgments

Much of this Annex is adapted from the National Advisory Committee on Microbiological 

Criteria for Foods, Hazard Analysis and Critical Control Point Principles and Guidelines, 

adopted August 14, 1997.

The physical hazards table (Table 3) was provided courtesy of “Overview of Biological, 

Chemical, and Physical Hazards” in “HACCP Principles and Applications,” Merle 

Pierson and Donald A. Corlett, Jr. (Eds.), 1992. p. 8-28. Chapman and Hall, New York.

Based on a recommendation from the Retail HACCP Committee of the Conference for 

Food Protection, the two HACCP Manuals have been endorsed by the Conference.

9. Resources and References

A. Articles

1. Bryan, Frank “Hazard Analyses of Street Foods and Considerations for Food 

Safety.” Dairy, Food and Environmental Sanitation, February 1995, pp. 64-69.

2. Bryan, Frank “HACCP: Present Status and Future in Contribution to Food 

Safety.” Dairy, Food & Environmental Sanitation, November 1994, pp. 650-655.

3. Bryan, Frank “Procedures for Local Health Agencies to Institute a Hazard 

Analysis Critical Control Point Program for Food Safety Assurance in Food 
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Service Operations.” Journal of Environmental Health, March/April 1985, pp. 241-

245.

4. Bryan, Frank “Hazard Analysis of Food Service Operation.” Food Technology, 

February 1981, pp. 78-87.

5. Bryan, Frank “Hazard Analysis Critical Control Point Approach: Epidemiologic 

Rationale and Application to Food Service Operations.” Journal of Environmental 

Health, August 1981, pp. 7-14.

6. Bryan, Frank “Factors that Contribute to Outbreaks of Foodborne Disease.”

Journal of Food Protection, October 1978, pp. 816-827.

7. Briley and Klaus “Using Risk Assessment as a Method of Determining Inspection 

Frequency.” Dairy and Food Sanitation, December 1985, pp. 468-474.

8. Centers for Disease Control and Prevention. Surveillance for Foodborne Disease 

Outbreaks – United States, 1993-1997. Morbidity Mortality Weekly Report, #49 

(SS01), USPHS, March 17, 2000, pp. 1-51.

9. Mead, P.S., Slutsker, L., Dietz, V., McCraig, L.F., Bresee, J.S., Shapiro, C., 

Griffin, P.M., Tauxe, R.V. “Food-related Illness and Death in the United States.”

Emerg. Infect. Dis. Vol. 5, No. 5, 1999. Found at: 

http://www.cdc.gov/ncidod/EID/vol5no5/mead.htm.

10.National Advisory Committee on Microbiological Criteria for Food (NACMCF).

1997 Hazard Analysis and Critical Control Point System, USDA - FSIS 

Information Office, 1997.

11.National Advisory Committee on Microbiological Criteria for Food (NACMCF). 

1992 Hazard Analysis and Critical Control Point System, Int. J. Food 

Microbiology, 16:1-23.

12.National Food Processors Assoc. “HACCP Implementation: A Generic Model for 

Chilled Foods.” Journal of Food Protection, December, 1993, pp. 1077-1084.

13.President’s Council on Food Safety. The Food Safety Strategic Plan, 2001. Ch. 

2: Vision, Goals, Objectives, and Action items.

14.Silliker, John, Ph.D. “Microbiological Testing and HACCP Programs.” Dairy, Food 

and Environmental Sanitation, October 1995, pp. 606-610.

15.Stier, R.F., and Blumenthal, M.M., Ph.D. “Will HACCP be Carrot or Stick.” Dairy, 

Food and Environmental Sanitation, October 1995, pp. 616 - 620.

16.Tisler, J.M. “The Food and Drug Administration’s Perspective on HACCP,” Food 

Technology, June 1991, pp. 125-127.

17.Tompkin, R.B. “The Use of HACCP in the Production of Meat and Poultry 

Products.” Journal of Food Protection, September 1990, pp. 795-803.

18.Weingold, S.E., et al. “Use of Foodborne Disease Data for HACCP Risk 

Assessment.” Journal of Food Protection, September 1994, pp. 820-830.
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B. Books

1. Corlett, D.A. and Pierson, M.D. HACCP, Principles & Applications, ed., Chapman 

and Hall, New York, 1992.

2. Diseases Transmitted by Foods, 2nd ed., Centers for Disease Control, USPHS, 

1982.

3. Fellows, P.J. Food Processing Technology, Principles and Practice, Ellis 

Horwood, New York, 1990.

4. Fennema, O.R. Food Chemistry, 2nd ed., Marcel Dekker, Inc., New York, 1985.

5. Foodborne Diseases, ed. D.O. Cliver, Academic Press, San Diego, California, 

1990.

6. HACCP Reference Book, National Restaurant Assoc., The Educational 

Foundation, Chicago, 1994.

7. Heymann, David L. MD, (Ed.), 2004. Control of 

8. Communicable Diseases Manual, 18th Ed.,

9. American Public Health Association, Washington D.C.

10.Jay, J.M. Modern Food Microbiology, 4th ed., Van Nostrand Reinhold, New York, 

1992.

11.Potter, N.N., J.H. Hotchkiss, 1999. Food Science, 5th ed., Kluwer Academic 

Publishers, Secaucus, NJ.

12.Stevenson, K.E., D.T. Bernard, 1999. HACCP: A Systematic Approach to Food 

Safety, 3rd ed., Food Processors Institute, Washington, DC, 1999. 

C. FDA Publications

1. Regulations, 21 CFR, Part 123 Fish and Fishery Products.

2. The latest edition of The Fish and Fishery Products Hazards and Controls 

Guidance is available electronically at: 

http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInf

ormation/Seafood/ucm2018426.htm. Single copies may be obtained as long as 

supplies last from FDA district offices and from:

U.S. Food and Drug Administration

Office of Seafood

5001 Campus Drive

College Park, MD 20740-3835

3. Food and Drug Administration/U.S. Public Health Service, 2003. National 

Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish, at: 
FDA Food Code 2022 

Annex 4. Management of Food Safety Practices - Achieving Active Managerial Control

of Foodborne Illness Risk Factors

Annex 4 - 38

http://www.fda.gov/Food/GuidanceRegulation/FederalStateFoodPrograms/ucm2

006754.htm. 

4. Report of the FDA Retail Food Program Database of Foodborne Illness Risk 

Factors, 2000.The Baseline Report is available from FDA at: 

https://www.fda.gov/food/guidanceregulation/retailfoodprotection/foodborneillnes

sriskfactorreduction/default.htm.

5. FDA Report on the Occurrence of Foodborne Illness Risk Factors in Selected 

Institutional Foodservice, Restaurant, and Retail Food Store Facility Types 

(2004). This second report is available from FDA through the following website:

https://www.fda.gov/food/guidanceregulation/retailfoodprotection/foodborneillnes

sriskfactorreduction/default.htm

6. FDA Report on the Occurrence of Foodborne Illness Risk Factors in Selected 

Institutional Foodservice, Restaurant, and Retail Food Store Facility Types 

(2009). This third report is available from FDA at: 

https://www.fda.gov/food/guidanceregulation/retailfoodprotection/foodborneillnes

sriskfactorreduction/default.htm

7. FDA Trend Analysis Report on the Occurrence of Foodborne Illness Risk Factors 

in Selected Institutional Foodservice, Restaurant, and Retail Food Store Facility 

Types (1998-2008) (October 2010). This trend report is available from FDA at: 

https://www.fda.gov/food/guidanceregulation/retailfoodprotection/foodborneillnes

sriskfactorreduction/default.htm
FDA Food Code 2022 Annex 5. Conducting Risk-Based Inspections

Annex 5 - 1

Annex 5 Conducting Risk-Based 

Inspections

1. Purpose and Scope

2. RISK-based Routine Inspections

3. What Is Needed to Properly Conduct a Risk-Based Inspection?

4. RISK-based Inspection Methodology

5. Achieving On-Site and Long-Term Compliance

6. Inspection Form and Scoring

7. Closing Conference

8. Summary

1. Purpose and Scope

This Annex provides regulatory program managers and front-line inspection staff with 

guidance on planning, scheduling, conducting, and evaluating risk-based inspections.

The FDA’s Voluntary National Retail Food Regulatory Program Standards (Program 

Standards) 

(http://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/ProgramStandards

/default.htm ) provide additional recommendations to assist regulatory program 

managers in the planning and development of a risk-based inspection program.

The primary focus of this Annex is to provide inspectors with methods for conducting 

risk-based inspections. Various strategies that can be used by regulatory professionals 

to assist operators in achieving active managerial control of foodborne illness risk 

factors are also included in this Annex. 

As presented in Annex 4, the Centers for Disease Control and Prevention (CDC) Surveillance 

Report for 1993-1997, “Surveillance for Foodborne Disease Outbreaks – United States” 

(http://www.cdc.gov/mmwr/preview/mmwrhtml/ss4901a1.htm ) identifies the most frequently 

reported contributing factors to foodborne illness. Five of these broad categories of contributing 

factors directly relate to food safety concerns within retail and food service establishments and 

are collectively termed by the FDA as “foodborne illness risk factors.”
FDA Food Code 2022 Annex 5. Conducting Risk-Based Inspections

Annex 5 - 2

These five broad categories are: 

• Food from Unsafe Sources

• Inadequate Cooking

• Improper Holding Temperatures

• Contaminated Equipment

• Poor Personal Hygiene. 

The FDA manual, Managing Food Safety: A Regulator’s Manual for Applying HACCP 

Principles to Risk-based Retail and Food Service Inspections and Evaluating Voluntary 

Food Safety Management Systems (FDA’s Regulator’s Manual)

(http://www.fda.gov/Food/GuidanceRegulation/HACCP/ucm2006812.htm), provides 

additional information on conducting risk-based inspections. Annex 4 of the Food Code 

provides additional information on Hazard Analysis and Critical Control Point (HACCP) 

principles and the process approach to HACCP. It should be reviewed in conjunction

with the material found in this Annex to better prepare for performing risk-based 

inspections.

The "Retail Food Program Resource Guide," a CD-ROM containing pertinent FDA 

documents referenced in this Annex, is available for use by federal, state, local, and 

tribal regulatory agencies. It is produced by and available through FDA Regional Retail 

Food Specialists or the FDA Division of Federal-State Relations (HFC-150); U.S. Food 

and Drug Administration; 5600 Fishers Lane, Room 12-07; Rockville, Maryland 20857;

PHONE (301) 827-6906; (FAX) (301) 443-2143.

2. RISK-based Routine Inspections

Inspections have been a part of food safety regulatory activities since the earliest days 

of public health. The term "routine inspection” has been used to describe periodic 

inspections conducted as part of an on-going regulatory scheme.

Program managers should strive to have adequate staffing and resources to allow all 

inspectors ample time to thoroughly evaluate establishments and ask as many 

questions as needed to fully understand establishments’ operations. For most 

jurisdictions, however, inspectors continue to have limited time in which to complete 

inspections. This does not negate the need to thoroughly identify and assess the control 

of foodborne illness risk factors during each inspection.

It is a false assumption that inspectors cannot conduct risk-based inspections in a 

limited timeframe. Even with limited time, inspectors can focus their inspections on 

assessing the degree of active managerial control an operator has over the foodborne 

illness risk factors. By focusing inspections on the control of foodborne illness risk 

factors, inspectors can be assured that they are making a great impact on reducing 

foodborne illness. 

As described in Annex 4, active managerial control means the purposeful incorporation 

of specific actions or procedures by industry management into the operation of their

businesses to attain control over foodborne illness risk factors. It embodies a preventive 
FDA Food Code 2022 Annex 5. Conducting Risk-Based Inspections

Annex 5 - 3

rather than reactive approach to food safety through a continuous system of monitoring 

and verification. 

Developing and implementing food safety management systems to prevent, eliminate, 

or reduce the occurrence of foodborne illness risk factors is recommended to achieve 

active managerial control. Regulatory inspections and follow-up activities must be 

proactive by using an inspection process designed to evaluate the implementation of 

Food Code interventions and the degree of active managerial control that retail and 

foodservice operators have over foodborne illness risk factors. The five Food Code 

interventions below were new interventions introduced with the 1993 Food Code and 

they are just as important today as they were in 1993. They encompass a wide-range of 

control measures specifically designed to protect consumer health:

• Demonstration of Knowledge

• Implementation of Employee Health Policies

• Hands as a Vehicle of Contamination

• Time/Temperature Relationships

• Consumer Advisory. 

When Food Code interventions are not being implemented or if behaviors, activities, or 

procedures likely to cause foodborne illness are observed, inspectors should verify that 

the operator takes immediate corrective action so that consumers do not become sick 

or injured. Observations made on the day of the inspection, as well as information 

gained about the behaviors, activities, and procedures that occur at other times, allow 

inspectors to assess the strengths and weaknesses of the food safety management 

system that is in place.

An operator should be made aware of the inspectional findings both during, and at the 

conclusion of, the inspection and strategies for achieving compliance in the future 

should be discussed. Corrective actions taken during the inspection and repeat 

violations should be noted on the inspection report. Repeat violations should trigger 

further compliance and enforcement actions. 

The inspection process is also an opportunity to educate the operator on the public 

health reasons supporting the Code requirements. If operators are afforded the chance 

to ask questions about general food safety matters, they may clearly understand the 

public health significance of non-compliance. 

Lastly, if the operator demonstrates a history of violations related to foodborne illness 

risk factors, the inspection process can be used to assist the operator with implementing 

long-term control systems to prevent those risk factors from occurring in the future.
FDA Food Code 2022 Annex 5. Conducting Risk-Based Inspections

Annex 5 - 4

3. What Is Needed to Properly Conduct a Risk-Based Inspection?

A. Schedule Inspections Based on Risk

Studies have shown that the types of food served, the food preparation processes 

used, the volume of food, and the population served all have a bearing on the 

occurrence of foodborne illness risk factors in retail and foodservice establishments.

Standard 3 of the Program Standards requires that regulatory jurisdictions develop 

and use a process that groups food establishments into at least three categories 

based on potential and inherent food safety risks. In addition, Standard 3 requires 

that regulatory jurisdictions assign inspection frequency based on the risk categories 

to focus program resources on food operations with the greatest food safety risk.

With limited resources, creating a variable inspection frequency for each category 

will allow inspection staff to effectively spend more time in high risk establishments 

that pose the greatest potential risk of causing foodborne illness.

Table 1 of this Annex provides an example of risk categories and assignment of 

inspection frequency based on risk. In this example, the type of food served, food 

preparation processes conducted, and history of compliance related to foodborne 

illness risk factors are used as the basis of categorizing risk. Each jurisdiction is 

encouraged to develop risk categories tailored to their specific program needs and 

resources and to reassess the risk categories on an annual basis.

Regardless of the risk category initially assigned to food establishments, regulatory 

jurisdictions sometimes consider whether the establishment has implemented a 

voluntary food safety management system like HACCP, to justify a decrease in 

inspection frequency. Likewise, the following factors are among many that regulatory 

jurisdictions sometimes use to justify an increase in inspection frequency: 

• History of non-compliance with provisions related to foodborne illness risk 

factors or critical items

• Specialized processes conducted

• Food preparation a day in advance of service

• Large number of people served

• History of foodborne illness and/or complaints

• Highly susceptible population served. 
FDA Food Code 2022 Annex 5. Conducting Risk-Based Inspections

Annex 5 - 5

Annex 5, Table 1. Risk Categorization of Food Establishments

RISK 

CATEGORY DESCRIPTION FREQUENCY#/YR

1

Examples include:

• Most convenience store operations, hot dog 

carts, and coffee shops.

• Establishments that serve or sell only prepackaged, non- time/temperature control for 

safety (TCS) foods.

• Establishments that prepare only non-TCS

foods.

• Establishments that heat only commercially 

processed, TCS foods for hot holding. No cooling 

of TCS foods. 

• Establishments that would otherwise be grouped 

in Category 2 but have shown through historical 

documentation to have achieved active 

managerial control of foodborne illness risk 

factors.

1

2

Examples may include:

• Retail food store operations, schools not serving 

a highly susceptible population, and quick 

service operations. Limited menu. Most products 

are prepared/cooked and served immediately.

May involve hot and cold holding of TCS foods 

after preparation or cooking. Complex 

preparation of TCS foods requiring cooking, 

cooling, and reheating for hot holding is limited to 

only a few TCS foods.

• Establishments that would otherwise be grouped 

in Category 3 but have shown through historical 

documentation to have achieved active 

managerial control of foodborne illness risk 

factors.

• Newly permitted establishments that would 

otherwise be grouped in Category 1 until history 

of active managerial control of foodborne illness 

risk factors is achieved and documented.

2
FDA Food Code 2022 Annex 5. Conducting Risk-Based Inspections

Annex 5 - 6

RISK 

CATEGORY DESCRIPTION FREQUENCY#/YR

3

Examples include:

• A full service restaurant with extensive menu and 

handling of raw ingredients. Complex preparation 

including cooking, cooling, and reheating for hot 

holding involves many TCS foods. Variety of 

processes require hot and cold holding of TCS 

food.

• Establishments that would otherwise be grouped 

in Category 4 but have shown through historical 

documentation to have achieved active 

managerial control of foodborne illness risk 

factors.

• Newly permitted establishments that would 

otherwise be grouped in Category 2 until history 

of active managerial control of foodborne illness 

risk factors is achieved and documented.

3

4

Examples include:

• Preschools, hospitals, nursing homes, and 

establishments conducting processing at retail. 

• Establishments serving a highly susceptible 

population or that conduct specialized 

processes, e.g., smoking and curing; reduced 

oxygen packaging for extended shelf-life. 

4

B. Have the Proper Equipment 

In order to conduct risk-based inspections, each inspector must be provided with the 

proper equipment to assess the control of foodborne illness risk factors within food 

establishments. See Program Standard 8 at 

http://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/ProgramStandar

ds/default.htm for recommendations of equipment needed by inspectors. At a 

minimum, each inspector should be provided with the following essential equipment: 

• Thermocouple with the appropriate probes for the food being tested

• Alcohol swabs or other suitable equipment for sanitizing probe thermometers

• Chemical test kits for different chemical sanitizer types

• Heat-sensitive tape or maximum registering thermometer

• Flashlight
FDA Food Code 2022 Annex 5. Conducting Risk-Based Inspections

Annex 5 - 7

• Head cover, such as baseball cap, hair net, or equivalent. 

Other equipment may be provided to inspectors on an “as needed” basis. While it is 

desirable for each inspector to have the following equipment, depending on the 

resources available to the agency, this equipment may be shared in a central office 

as appropriate:

• Pressure gauge for determining in-line pressure of hot water at injection point 

of warewashing machine (5-30 psi) 

• Light meter 

• Measuring device for measuring distances 

• Time/temperature data logger 

• pH meter 

• Water activity meter 

• Camera 

• Computers with or without an electronic inspection system 

• Black light

• Foodborne illness investigation kits

• Sample collection kits

• Cell phones

C. Provide Adequate Training

Standard 2 of the Program Standards explains that regulatory staff shall have the 

knowledge, skills, and ability to adequately perform their required duties. Inspectors 

need the proper training before they can be expected to conduct risk-based 

inspections. Training includes a combination of classroom training, in-field training, 

standardization, and continuing education. For specific training recommendations 

refer to Program Standard 2 at 

http://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/ProgramStandar

ds/default.htm and its accompanying Appendix B at the aforementioned website.

1. Classroom Training

The first phase of staff training should provide an orientation to the program with 

a review of program history, structure, and relationships to other food-related 

programs. Specific emphasis should be on the program's goals and objectives.

The basic training curriculum should include the following components:

• Prevailing statutes, regulations, or ordinances

• Public health principles

• Communication skills

• Epidemiology

• Microbiology

• HACCP.
FDA Food Code 2022 Annex 5. Conducting Risk-Based Inspections

Annex 5 - 8

FDA’s ORA-U 

(http://www.fda.gov/Training/ForStateLocalTribalRegulators/ucm121831.htm)

provides basic curriculum components free of charge to regulators via the 

internet. This allows state, local, and tribal health departments to conserve their 

time and funding resources instead of developing their own training courses. It 

also allows inspectors to access training as needed. Distance learning allows 

government agencies and industries to cost-effectively disseminate the most 

current technical and regulatory information on an as-needed basis. 

2. Field Training and Experience

The second phase of training should move the new inspector into the field with a 

training officer. On-site training should focus on specific inspection tasks such as 

interviewing, making observations, measuring conditions such as temperatures 

and sanitizer strength, assessing the control operators have over the foodborne 

illness risk factors, ensuring implementation of Food Code interventions, and 

completing the inspection form. If an electronic database is used by the agency, 

training in its use should be included in this phase. 

The evaluation of food safety management systems based on HACCP principles 

should be part of the field training experience. The trainee and the trainer should 

review establishment menus, operations, recipes, and standard operating 

procedures. Inspectors should be able to demonstrate proficiency in gathering 

information about the food preparation processes, including accurate charting of 

the food flows and determination of the Critical Control Points (CCPs) and critical 

limits in an operation. This part of the training should also include a familiarization 

with the compliance and enforcement protocol in place in the jurisdiction 

including recommendation of voluntary strategies to prevent risk factor 

occurrence.

3. Standardization

The third part of staff training should include standardization. This process 

improves uniformity in the application and interpretation of applicable regulations, 

inspection methodology, and report writing. The Program Standards recommend 

that staff conducting inspections undergo a standardization process similar to the 

one described in the FDA Procedures for Standardization and Certification of 

Retail Food Inspection/ Training Officers

(https://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/Standardiz

ation/default.htm). Standardization should be completed after the trainee 

completes classroom and field training. 
FDA Food Code 2022 Annex 5. Conducting Risk-Based Inspections

Annex 5 - 9

4. Continuing Education

The training process for inspection staff should be continuous. The final phase of 

training should include a mechanism to ensure that learning is ongoing and staff 

is kept abreast of food safety issues and the latest science.

D. Ensure Adequate Program Resources 

As indicated in Standard 8 of the Program Standards, regulatory agencies should 

have adequate funding, staff, and equipment necessary to support a risk-based 

retail food safety program designed to reduce the occurrence of foodborne illness 

risk factors. Program management should do everything they can to secure funding 

and resources to support regulatory food programs.

Standard 8 of the Program Standards also states that the program budget should 

provide the necessary resources to develop and maintain a retail food safety 

program that has a staffing level of one full-time equivalent (FTE) devoted to food for 

every 280 - 320 inspections performed. Inspections, for purposes of this calculation, 

include routine inspections, re-inspections, complaint investigations, outbreak 

investigations, compliance follow-up inspections, risk assessment reviews, process 

reviews, variance process reviews, and other direct establishment contact time such 

as on-site training. 

4. Risk-based Inspection Methodology

A. Focus the Inspection

Conducting a risk-based inspection requires inspectors to focus their efforts on 

evaluating the degree of active managerial control that operators have over 

foodborne illness risk factors. In addition, it is essential that the implementation of 

Food Code interventions also be verified during each inspection. Inspectors need to 

spend the majority of their time observing the behaviors, practices, and procedures 

that are likely to lead to out-of-control foodborne illness risk factors and asking 

management and food employees questions to supplement actual observations. 

Retail and food service operators implement “control measures” to ensure food 

safety. Control measures are actions or activities that are used to prevent, eliminate, 

or reduce food safety hazards. Inspectors need to determine the control measures 

that should be implemented to prevent the occurrence of foodborne illness risk 

factors in each food preparation process. In order to determine the foodborne illness 

risk factors common to each operation, it is important for inspectors to understand 

that the food preparation processes and all the associated control measures initiated 

by a retail or food service operator represent a food safety management system. It 

will be necessary for inspectors to ask questions in order to gain information about 

the system already in place. Once the degree of active managerial control is 

determined, inspectors will be able to assist operators with strengthening their 

existing food safety management systems.
FDA Food Code 2022 Annex 5. Conducting Risk-Based Inspections

Annex 5 - 10

B. Lead by Example

Nonverbal communication is just as important as verbal communication in relaying 

important food safety principles to retail and food service operators. By setting the 

example during inspections, inspectors not only demonstrate competency, but they 

also relay important food safety information to the person in charge and food

employees. The following are ways that inspectors set the example during 

inspections:

• Washing their hands when entering the food preparation area at the 

beginning of the inspection and after engaging in any activities that might 

contaminate their hands

• Not working when they are suffering from symptoms such as diarrhea, fever, 

vomiting, or jaundice or if they are diagnosed with a disease transmittable by 

food

• Being careful not to touch ready-to-eat (RTE) food with their bare hands

• Washing and sanitizing their thermocouple probe at the start of the inspection 

and between foods

• Using a proper hair restraint and practicing good personal hygiene

• Being careful not to contaminate clean and sanitized food contact-surfaces 

with unclean hands or their inspection equipment. 

C. Conduct Inspections at Variable Times

Inspectors should enter the food establishment during hours of operation or at other 

reasonable times. Inspectors should show identification and provide the permit 

holder or person in charge with a verbal or written notice of the purpose of the 

inspection. Procedures outlined in the Food Code and in the jurisdiction’s 

procedures should be followed if access to conduct an inspection is denied. Refusal 

should be documented on the inspection report and an administrative or judicial 

inspection order obtained. 

In planning for inspections, inspectors should consider the importance of timing.

Several operational steps at retail such as receiving, preparation, and cooling can be 

evaluated only during limited time periods. In order to properly evaluate critical 

processes that occur outside of the normal 8 a.m. to 5 p.m. working hours, an 

inspector should be allowed the flexibility to conduct inspections early in the 

morning, late in the evening, and even on weekends.

D. Establish Inspection Priorities and Use Inspection Time Wisely

With the limited time allotted for inspections, inspectors must develop clear priorities 

to make the most efficient use of their time in each food establishment. Although 

basic sanitation issues generally do not change during the course of an inspection, 

critical behaviors, practices, and procedures leading to foodborne illness risk factors 

may be only observable during limited time periods of the preparation or cooling 

process. For this reason, assessment of the active managerial control of foodborne 
FDA Food Code 2022 Annex 5. Conducting Risk-Based Inspections

Annex 5 - 11

illness risk factors should generally be performed before reviewing basic sanitation 

issues.

To effectively set priorities, the following four activities should be completed early in 

the inspection: 

1. Establish an Open Dialogue with the Person in Charge

2. Review Previous Inspection Reports

3. Conduct a Menu/Food List Review

4. Conduct a Quick Walk-through

1. Establish an Open Dialogue with the Person in Charge

The tone of the inspection is often set during the first few minutes of the 

inspection. A professional but personable approach is the balance which should 

be maintained. Genuine interest in the food establishment and the staff translates 

into good relations which may be helpful in conveying the goal of promoting 

public health. Having an open dialogue with the person in charge during all 

phases of the inspection gives inspectors an opportunity to learn important 

information about the existing food safety management system. 

It is important to know both the strengths and weaknesses of the existing food 

safety management system early in the inspection in order to focus the 

inspection on weak areas. Questions about practices and procedures related to 

foodborne illness risk factors and Food Code interventions such as the 

establishment’s employee health policy and consumer advisory notice should be 

asked during all phases of the inspection. It is important to ask enough questions 

to fully understand the system being utilized in the food establishment. This is 

especially true when evaluating whether the employees are adhering to the 

established no bare hand contact and handwashing policies. Asking the person 

in charge questions about important activities such as receiving, cooling, and 

preparation is also important in relaying the importance of out-of-control 

foodborne illness risk factors.

The person in charge should be encouraged to accompany inspectors during the 

inspection. This may ultimately save time since violations can be pointed out and 

corrected as they are observed. In addition, the importance of violations related 

to foodborne illness risk factors and Food Code interventions is more apparent if 

they are pointed out during the inspection rather than waiting until the end.

Violations should be marked on the inspection form even if immediate corrective 

actions are taken. Corrective actions taken should also be recorded on the 

inspection form. Inspectors can also use this time to share knowledge about 

critical processes. By communicating the public health rationale behind the 

regulations, inspectors will leave the person in charge with a clear understanding 

for why active managerial control of foodborne illness risk factors must be a top 

priority in the day-to-day operation of the business.
FDA Food Code 2022 Annex 5. Conducting Risk-Based Inspections

Annex 5 - 12

Early in the inspection, inspectors should inquire about activities that are 

presently occurring. Processes that occur over time like cooling and reheating 

also need to be assessed over time; thus, inspectors should ask in the beginning 

of the inspection if any foods are currently being cooled or reheated. 

It is important for inspectors to allow the operator a chance to discuss issues 

related to food safety. One-way communication in which inspectors do all the 

talking is not conducive to a risk-based philosophy. An effective risk-based 

inspection is dependent on inspectors’ ability to maintain two-way communication 

in order to properly assess behaviors, processes, and procedures that occur in 

the food establishment.

2. Review Previous Inspection Reports

In order to detect trends of out-of-control foodborne illness risk factors, it is 

important for inspectors to review past inspection reports before conducting an 

inspection. This can be done in the office or on-site in the food establishment.

This activity is especially important in jurisdictions where inspectors rotate from 

one inspection to the next. If the same foodborne illness risk factor is out-ofcontrol during more than one inspection, it is strongly recommended that the 

operator develop an intervention strategy to prevent its recurrence. Intervention 

strategies are discussed later in this Annex. 

Knowledge of what has been corrected from the last inspection also gives 

inspectors an opportunity to provide positive feedback to the operator and allows 

inspectors to track corrected violations in accordance with their jurisdiction’s 

policies and procedures.

3. Conduct a Menu/Food List Review

Menus, including all written and verbal lists of foods prepared and offered in a 

food establishment, can be reviewed in a fairly simple manner. The review can 

either be done simultaneously with a quick walk-through of the operation or at the 

beginning of the inspection as a discussion with management. The menu/food list 

also does not need to be reviewed during every inspection. If a review was done 

during a recent inspection, inspectors should inquire about new items, seasonal 

items, substitutions, or changes in preparation since the last menu review was 

conducted. 

A review of the menu/food list allows inspectors to begin to group food items into 

one of three broad process categories (discussed in Annex 4 of the Food Code 

and later in this Annex). Mentally grouping products by process assists 

inspectors in focusing the inspection on the control measures critical to each 

process.
FDA Food Code 2022 Annex 5. Conducting Risk-Based Inspections

Annex 5 - 13

Conducting a review of the menu/food list also allows inspectors to establish 

inspection priorities by identifying: 

• High-risk foods or high-risk food preparation processes 

• Operational steps requiring further inquiry such as receiving, preparation, 

cooking, and cooling.

By identifying high-risk foods or high-risk food preparation processes, inspectors

can focus the inspection on those foods or processes that are more likely to 

cause foodborne illness if uncontrolled. The menu/food list review might be the 

only time inspectors are made aware of specialized processes such as 

formulating a food so that it is not time/temperature control for safety food (TCS) 

or high-risk seasonal menu items such as “raw oysters on the half shell.” Foods 

such as shellstock and certain fish for raw consumption require documentation 

that should be reviewed during the inspection. If Caesar salad or hollandaise 

sauce is served, further inquiry is needed regarding the preparation of these 

items since they are sometimes prepared with raw or undercooked eggs.

Several operational steps like receiving, preparation, cooking, and cooling may 

not be inspected as vigorously in retail and food service inspections due, in part, 

to the hours of the day in which these steps occur. If a food establishment is 

inspected in the afternoon hours, for example, receiving and food preparation 

might have already occurred. In order to evaluate the establishment’s active 

managerial control of foodborne illness risk factors, it is imperative that 

inspectors ask enough questions to obtain information about the operational 

steps that they cannot directly observe during the current inspection.

4. Conduct a Quick Walk-through 

As inspectors discuss the menu or food list and establishes open communication 

with the person in charge, it is suggested that they conduct a quick walk-through 

of the food establishment to observe what is going on at that time. Conducting a 

quick walk-through is especially important to observe several activities that might 

otherwise go unnoticed or unobserved until later in the inspection, including:

• Receiving

• Food preparation and handling

• Cooking

• Cooling

• Reheating

Speaking directly to the food service employees preparing the food is also an 

excellent way to assess the effectiveness of the establishment’s food safety 

training and standard operating procedures for critical processes such as cooling.

Noting that receiving or food preparation is occurring at the beginning of the 

inspection allows inspectors an opportunity to take advantage of viewing “reallife” production processes and will help inspectors to obtain a clear picture of the 

establishment's true practices. Receiving and food preparation only occur during 
FDA Food Code 2022 Annex 5. Conducting Risk-Based Inspections

Annex 5 - 14

limited times, so inspectors may want to stop and observe these operational 

steps while they are happening.

Early in the inspection, temperatures of time/temperature control for safety foods 

(TCS) should be taken. For example, if inspecting in the morning, inspectors

should check the temperatures of last night’s stored leftovers. If inspecting in the 

afternoon, inspectors should check the temperatures of foods prepared that 

morning that are now cooling. Also, inspectors should ask whether any foods are 

currently being cooked or reheated. 

E. Determine Process Flows 

Many retail and food service establishments have implemented effective food safety 

management systems by establishing controls for the food preparation methods and 

processes common to their operation. Control of food preparation processes rather 

than individual food items is often called the “process approach” to HACCP. The 

process approach using the principles of HACCP can best be described as dividing 

the many food items in an operation into food preparation processes then analyzing

the foodborne illness risk factors associated with each process. By placing 

managerial controls on specific operational steps in the flow of food, foodborne 

illness can be prevented.

As presented in Annex 4 of the Food Code, most food items produced in a retail or 

food service establishment can be categorized into one of three preparation 

processes based on the number of times the food passes through the temperature 

danger zone between 41o F and 135o F. In conducting risk-based inspections, it is 

necessary for an inspector to be knowledgeable regarding how food is prepared in 

the operation. Knowing how products are prepared in an establishment allows 

inspectors to focus their inspections on the critical procedures and steps in the 

preparation of those products.

F. Determine Foodborne Illness Risk Factors In Process Flows 

Annex 4 of the Food Code details the essential control measures specific to each 

food preparation process, in addition to essential facility-wide control measures. 

Inspectors should generally focus their inspections on verifying that operators have 

implemented control measures to control for foodborne illness risk factors common 

to the processes conducted in each operation. There may be other foodborne illness 

risk factors unique to specific operations; thus, inspectors should independently 

evaluate each operation and food preparation process conducted.

G. Assess Active Managerial Control of Foodborne Illness Risk Factors and 

Implementation of Food Code Interventions 

Although some food establishments have formal HACCP plans, many do not. Even 

without a HACCP system, every food establishment needs to have active 

managerial control of foodborne illness risk factors. This may be achieved through 

several means, such as training programs, manager oversight, or standard operating 
FDA Food Code 2022 Annex 5. Conducting Risk-Based Inspections

Annex 5 - 15

procedures. For example, some food establishments incorporate control measures 

into individual recipes, production schedules, or employee job descriptions to 

achieve active managerial control. 

While a person in charge may require the maintenance of in-house written records 

by employees to ensure that monitoring is being performed using the correct method 

and at the proper frequency, foodborne illness risk factors may be managed without 

the use of formal record keeping. Monitoring, whether through direct observations or 

by taking appropriate measurements, is by far the most important step in ensuring 

food safety. If an operator is effectively monitoring all critical activities in the food 

establishment and taking corrective actions when needed, safe food will result. With 

a few exceptions, maintaining formal records at retail is not required; therefore, 

records may not be in place for use during the inspection. As a result, it will be 

necessary to use direct observations and interviewing to determine whether a food 

establishment is adequately monitoring foodborne illness risk factors in their existing 

food safety management system. 

This section provides a comprehensive discussion of how to assess the active 

managerial control of each of the foodborne illness risk factors and the 

implementation of each of the Food Code interventions. Assessment of active 

managerial control involves more than determining compliance with Food Code 

provisions. In assessing whether the operator has active managerial control, 

inspectors should observe whether the operator has established the appropriate 

control measures and critical limits and whether appropriate monitoring and 

corrective action procedures are in place and followed. In addition, inspectors should 

assess whether managers and employees are knowledgeable of food safety 

principles and critical practices and procedures necessary to prevent foodborne 

illness. If during the inspection inspectors observes that control measures are not 

being implemented appropriately to control risk factor occurrence, immediate 

corrective action must be taken.

1. Demonstration of Knowledge

It is the responsibility of the person in charge to ensure compliance with the 

Code. Knowledge and application of Food Code provisions are vital to preventing 

foodborne illness and injury. Data collected by FDA suggest that having a 

certified food manager on-site has a positive effect on the occurrence of certain 

foodborne illness risk factors in the industry.

In order to assess whether the person in charge demonstrates knowledge, 

inspectors should verify that the person in charge has one or more of the 

following:

• A valid food protection manager certificate 

• No priority item violations during the current inspection

• Correct responses to food safety related questions as presented in 

¶ 2-102.11(C) of the Food Code. 
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Annex 5 - 16

2. Assessing Safe Sources and Receiving Temperatures

The time and day of the inspection is important when assessing whether foods 

are received from safe sources and in sound condition. Foods may be received 

in the food establishment on set days. Inspectors should ask questions to 

ascertain the day or days that deliveries are received and also the receiving 

procedures in place by the food establishment. Inspections can be scheduled at 

times when it is known that products will be received by the food establishment. If 

food is being delivered during the inspection, inspectors should:

• Verify internal product temperatures 

• Examine package integrity upon delivery

• Look for signs of temperature abuse (e.g., large ice crystals in the 

packages of frozen products) 

• Examine delivery truck and products for potential for cross-contamination

• Observe the food establishment’s behaviors and practices as they relate 

to the establishment’s control of contamination and holding and cooling 

temperatures of received products

• Review receiving logs and other documents, product labels, and food 

products to ensure that foods are received from regulated food processing 

plants (no foods prepared at home) and at the proper temperature. 

When evaluating approved sources for shellfish, such as clams, oysters, and 

mussels, inspectors should ask whether shellfish are served at any time during 

the year. If so, inspectors should review the tags or labels to verify that the 

supplier of the shellfish is certified and on the most current Interstate Certified 

Shellfish Shippers List found at

(http://www.fda.gov/Food/GuidanceRegulation/FederalStateFoodPrograms/ucm2

006753.htm ). Inspectors should note whether all required information is provided 

on the tags or label (harvester’s certification number, harvest waters and date, 

type and quantity of shellfish and similar information for each dealer that handles 

the shellfish after the harvester). Shellstock tags should also be retained for 90 

days in chronological order.

With regard to fish, inspectors should verify that fish are commercially caught and 

harvested and received from reputable vendors. If fish are being delivered during 

the inspection or if they were received just before inspectors’ arrival, 

temperatures should be taken, especially if there are finfish such as tuna, mahimahi, bluefish, mackerel, and snapper. These fish are subject to scombrotoxin 

formation if time/temperature abused. Inspectors should verify freshness by 

conducting an organoleptic inspection of the gills, eyes, and bodies of the fish.

Inspector should verify that fish, except for certain species of tuna, intended for 

raw or undercooked consumption have been frozen for the required time and 

temperature parameters to destroy parasites by either reviewing freezing records 

or verifying that a letter of guarantee from the purveyor is kept on file. If freezing 

is conducted on-site, inspectors should verify that the freezing records are 

maintained for at least 90 days beyond the date of sale or service. 
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Annex 5 - 17

With regard to the service of game or wild mushrooms, inspectors should ask if 

these products are served at any time during the year. If so, inspectors should 

verify that they are from an approved source by reviewing invoices.

With regard to juice and milk products, inspectors should verify that fluid milk and 

milk products are pasteurized and received at the proper temperature. For 

packaged juice, inspectors should verify that the juice was pasteurized or 

otherwise treated to achieve a 5-log reduction of the most resistant

microorganism.

During the inspection, inspectors should inquire as to the source of foods that 

have been removed from their original containers. If at any time during the 

inspection there is any doubt as to the source of certain products, inspectors

should ask for invoices or receipts to demonstrate their source. Certain products, 

such as flat breads, waffles, pies, and cakes may require special cooking 

equipment to prepare. If suitable equipment is not on-site to prepare such 

products and the products are not stored in original containers, then inspectors

should inquire as to the source of these products.

Food from unapproved, unsafe, or otherwise unverifiable sources should be 

discarded or put on hold or under embargo until appropriate documentation is 

provided. In addition, inspectors should ensure that management and employees 

are aware of the risk of serving or selling food from unapproved sources. Fish 

that are intended to be consumed raw or undercooked and for which no freezing 

certification or equipment is found on-site, can be used in menu items that will be 

fully cooked. If cooking is not an option due to the menu items served, the fish 

should be discarded.

3. Assessing Contaminated Equipment and Potential for CrossContamination

This risk factor involves the proper storage and use of food products and 

equipment to prevent cross-contamination. The cleaning, sanitization, and 

storage of food-contact surfaces of equipment and utensils in a manner to 

prevent transmission of foodborne pathogens or contamination is also included in 

this risk factor.

As inspectors walk through the food establishment, they should examine food 

storage areas for proper storage, separation, segregation, and protection from 

contamination. Inspectors should look to see that raw animal foods and ready-toeat foods are separated during receiving, storage, and preparation. For example, 

cooked shrimp should not be returned to the same container that previously held 

uncooked product. Cutting boards should be washed, rinsed, and sanitized 

between trimming uncooked chicken and cooked steak. 

In addition, raw animal foods should be separated by cooking temperatures such 

that foods requiring a higher cooking temperature, like chicken, should be stored 

below or away from foods requiring a lower temperature, like pork and beef. If 
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Annex 5 - 18

TCS foods are not being cooled, they should be covered or packaged while in 

cold storage. 

Following the flow of food as it is prepared in the food establishment may alert 

inspectors to opportunities for cross-contamination. When contamination has 

occurred between raw and ready-to-eat food, inspectors should assess whether 

the food can be reconditioned. In some cases, depending on the affected food, it 

may be possible to reheat the food to eliminate any hazards. If the food cannot 

be reconditioned, then the food should be discarded.

Inspectors should verify that exposed food such as chips, bread, and dipping 

sauces are not re-served to the consumer. Consumer self-service operations are 

addressed in the Code with regard to the types of food offered for consumer selfservice, the protection of food on display, and the required monitoring by 

employees of such operations.

A visual check of the food-contact surfaces of equipment and utensils should be 

made to verify that the utensils are maintained clean and sanitized using the 

approved manner and frequency. Utensils that are observed to have debris, 

grease, or other visible contamination should be rewashed and resanitized.

Observations should be made to determine whether practices are in place to 

eliminate the potential for contamination of utensils, equipment, and singleservice items by environmental contaminants, employees, and consumers. When 

clean equipment and utensils are stored where they are subject to environmental 

contamination such as near handwashing sinks or prep sinks, inspectors should 

have the operator rearrange the equipment in a manner to prevent crosscontamination. Depending on the circumstances, the operator may need to 

rewash and resanitize the equipment.

Inspectors should observe handwashing operations. If handwashing sinks and 

fixtures are located where splash may contaminate food contact surfaces or food, 

then splash guards should be installed or food-contact surfaces should be 

relocated to prevent cross-contamination. 

Inspectors should pay particular attention to prep sinks, especially those that are 

currently in use at the time of the inspection. Built-up grime is a visible sign that 

the sink is not being washed, rinsed, and sanitized appropriately before use. If 

there are designated vegetable or meat sinks, inspectors should verify that the 

placement of sinks and food preparation areas do not facilitate opportunities for 

cross-contamination from one to the other.

With regard to the cleaning and sanitization of food-contact surfaces, inspectors

should verify the compliance of any warewashing operations by ensuring that 

cleaning and sanitizing procedures for all food-contact surfaces conform to the 

requirements in the Food Code. Questions should be asked to assess how 

utensils and cookware are washed, rinsed, and sanitized in the food 

establishment. When assessing the warewashing procedure and equipment, 

inspectors should pay particular attention to cooking and baking equipment that 

is too large to fit in the dishmachine or sinks. It is a good idea to have the person 
FDA Food Code 2022 Annex 5. Conducting Risk-Based Inspections

Annex 5 - 19

responsible for dishwashing demonstrate the procedure that is followed in the 

food establishment by setting up the sinks and watching the dishwashing 

procedure.

4. Assessing Cooking Temperatures

Food cooking temperatures and times should be verified by inspectors during 

each inspection. Every effort should be made to assess the cooking 

temperatures of a variety of products served in the food establishment.

To assess cooking, inspections must occur at times when food is being cooked.

It is also important to conduct inspections during busy times, such as lunch and 

dinner, as there may be a tendency for the operator to rush the cooking of foods 

during these times.

Critical limits for cooking TCS foods in the Food Code include specifications that 

all parts of the food be heated to a certain temperature. For large roasts, 

temperature measurement should take into account post-cooking heat rise which 

allows the temperature to reach equilibrium throughout the food. The critical limit 

of time at the terminal temperature must also be measured during inspections.

For example, a roast beef cooked at 54°C (130°F) is required to be held at this 

temperature for 112 minutes to ensure destruction of pathogens. Cooking times 

and temperatures should be noted on the inspection report. 

The correct temperature measuring device and technique are essential in 

accurately determining the temperatures of TCS foods. The geometric center or 

thickest part of a product are the points of measurement of product temperature 

particularly when measuring critical limits for cooking.

Inspectors should take internal temperatures of products using a thermocouple or 

thermistor with a probe suitable for the product thickness. A thin diameter probe 

should be used for temperature measurements of hamburger patties and fish 

filets.

Alternately, although less desirable, an inspector may use a suitable, calibrated 

bimetal stem thermometer for checking cooking temperatures of thick foods.

Infrared thermometers are inappropriate for measuring internal cooking 

temperatures.

In order to better assess cooking during all phases of the inspection, inspectors

could enlist the help of cooperative food employees to notify them of foods that 

have finished cooking. This allows inspectors to continue with the inspection in 

other areas of the operation yet continue to verify that proper cooking 

temperatures are being met.

Food establishments should routinely monitor cooking temperatures. Inspections 

should verify that monitoring is occurring by involving the person in charge in 

these activities during the regulatory inspection. The presence of required 

thermometers and their proper use should be assessed.
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Comparisons should be made between inspectors’ calibrated temperature 

measuring device and those used by the food establishment. Notation of 

deviations should be made on the inspection report. Inspectors should ask food 

establishment personnel to demonstrate proper calibration of their temperature 

measuring devices.

If required cooking temperatures are not met, inspectors should have the 

operator continue cooking the food until the proper temperature is reached.

Additionally, inspectors should explain the public health significance of 

inadequate cooking to management and food employees.

5. Assessing Holding Time and Temperatures and Date Marking

Hot and cold holding temperatures, as well as cooling time and temperatures, of 

TCS foods should be thoroughly checked with a thermocouple, thermistor, or 

other appropriate temperature measuring device during each inspection. This 

includes the temperature of TCS food during transport, e.g., hot holding carts 

being used to transport food to patient rooms in a hospital, satellite kitchens, or 

off-site catering events. As a rule, every effort should be made to assess every 

hot and cold holding unit in the food establishment during a risk-based 

inspection.

Use of an infrared thermometer for verifying holding temperatures is not 

consistent with Food Code requirements since verifying only the surface 

temperature of the food may not alert inspectors to problems that exist under the 

food’s surface. Such problems could stem from improper cooling, in the case of 

cold-held foods, or improper reheating, in the case of hot-held foods. In addition, 

inspectors should not stir a food before taking its temperature since it is important 

to know the temperature of the food before it is agitated.

The geometric center of a product is usually the point of measurement of product 

temperature particularly when measuring the critical limit for cold holding. 

The hot holding critical limit may need additional measurements taken at points 

farthest from the heat source, e.g., near the product surface for food held on a 

steam table. Temperatures monitored between packages of food, such as 

cartons of milk or packages of meat, may indicate the need for further 

examination. However, the temperature of a TCS food itself, rather than the 

temperature between packages, is necessary for regulatory citations. In large 

holding units and on steam tables, it is necessary to take the temperatures of 

foods in various locations to ensure that the equipment is working properly. If 

deviations are noted in the product temperatures, it is important to take extra 

steps to find out whether the problem is the result of equipment failure or whether 

a breakdown in a process such as cooling or reheating is the reason for the 

problem. 

Corrective actions for foods found in violation should be required based on the 

jurisdiction’s regulatory food code. If foods are to be discarded, forms such as 

those used for stop sale or embargo may need to be completed and signed by 
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Annex 5 - 21

the person in charge in accordance with the jurisdiction’s regulatory food code. In 

order to properly evaluate the degree of time and temperature abuse and the 

proper disposition of the affected food, several issues must be considered.

Answers to these questions, in combination with observations made during the 

inspection, should provide inspectors with enough information to make the 

appropriate recommendation for on-site correction:

• Are there any written procedures in place for using time alone as a public 

health control and, if so, are they being followed properly? 

• What are the ingredients of the food and how was it made?

• Is it likely that the food contains Clostridium perfringens, Clostridium 

botulinum, or Bacillus cereus as hazards?

• Has there been an opportunity for post-cook contamination with raw 

animal foods or contaminated equipment?

• If there has been an opportunity for post-cook contamination, can the 

hazards of concern be eliminated by reheating?

• Are the food employees practicing good personal hygiene including 

frequent and effective handwashing?

• Was the food reheated or cooked to the proper temperature before being 

allowed out of temperature control?

• What is the current temperature of the food when taken with a probe 

thermometer?

• How long has the food been out of temperature control (ask both the 

manager and food employees)? Are the answers of the food employees 

and the manager consistent with one another?

• Is it likely that food has cooled to its current temperature after being out of 

temperature control for the alleged time?

• Will the food be saved as leftovers?

• How long before the food will be served?

• Given what is known about the food, the food’s temperature, the handling 

of the food, and the alleged time out of temperature, is it reasonably likely 

that the food already contains hazards that cannot be destroyed by 

reheating?

Even if food can be reconditioned by reheating, steps should be taken by the 

person in charge to ensure compliance in the future. Examples include repairing 

malfunctioning or inoperative equipment or implementing a risk control plan 

(RCP) to modify preparation procedures or to institute a procedure for monitoring 

holding temperatures of food.
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Annex 5 - 22

If using time only or time-temperature combinations in lieu of temperature for 

controlling the growth and toxin-formation of pathogenic bacteria, strict controls 

must be in place and followed. Inspectors should verify that the written 

procedures are on-site and followed in accordance with the Food Code.

Date marking is the mechanism by which active managerial control of timetemperature combinations can prevent the growth of Listeria monocytogenes in 

TCS, ready-to-eat foods during cold storage. With exceptions, all ready-to-eat, 

TCS foods prepared on-site and held for more than 24 hours should be date 

marked to indicate the day or date by which the foods need to be served or 

discarded. Inspectors should ask questions to ascertain whether the system in 

place to control for L. monocytogenes meets the intent of the Food Code. Food 

that should be date marked and is not should be discarded.

6. Assessing Reheating for Hot Holding

In order to assess a food establishment’s control of reheating for hot holding, the 

time of day that the inspection occurs is a key factor. Every effort should be 

made to schedule an inspection during pre-opening preparation. If inspections 

are conducted during pre-opening preparation or other preparation periods, 

inspectors should ask questions regarding the history of hot-held foods. Foods in 

compliance for minimum hot holding temperatures may have in fact been 

improperly reheated before being placed into hot holding units or steam tables. 

If items are found “reheating” on the steam table, further inquiry is needed to 

assess whether the equipment in question is capable of reheating the food to the 

proper temperature within the maximum time limit. Corrective action for foods 

found out of compliance for reheating for hot holding would depend on how long 

the food had been out of temperature and other factors. In most cases, however, 

the food may be rapidly reheated and hot held.

7. Assessing Cooling

Improper cooling remains a major contributor to bacterial foodborne illness.

Cooling temperatures and times need to be closely evaluated during every 

inspection. In order to assess whether a food establishment has control over 

cooling, the time of day that the inspection occurs is critical. Early morning 

inspections allow an opportunity to verify that leftovers from the night before were 

cooled properly or cooled using a proper cooling method. Alternatively, afternoon 

inspections may allow an inspector to verify cooling of products that may have 

been prepared that morning.

Because many food establishments prepare bulk products only on certain days 

of the week, it is essential that inspectors become as familiar as possible with 

each operation and schedule their inspections accordingly. 

Due to the time parameters involved in cooling, inspectors should always inquire 

at the beginning of the inspection whether there are any products currently being 
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Annex 5 - 23

cooled. This allows inspectors an opportunity to take initial temperatures of the 

products and still have time to re-check temperatures later in the inspection in 

order to verify that critical limits are being met.

Problems with cooling can often be discovered through inquiry alone. Even when 

no cooling is taking place, inspectors should ask the food employees and 

managers questions about the cooling procedures in place.

When examining cold holding units, bulk containers and buckets, tightly packed 

pans, shrouded rolling racks, or closed rolling cabinets should warrant further 

temperature and time investigation. Bulk containers and buckets should be 

opened since they are commonly reused for food storage and cooling.

The geometric center of a product is often chosen as the point of measurement 

of product temperature particularly when measuring the critical limits for cooling.

For foods that are being cooled, temperature profiles throughout the product may 

show proper temperatures at outer edges and hot spots at the core of the 

product. Inspectors can verify cooling by first taking a temperature measurement 

in the geometric center of the product, then at various points around the 

perimeter of the product. Warmer temperatures in the center of the product, in 

combination with cooler temperatures around the perimeter, indicate that a 

product is cooling. Additional questions should be asked to ascertain the cooling 

time parameters of the food in question. Information gained from food employees 

and management, in combination with temperature measurements taken, should 

form the basis for assessing compliance of cooling during an inspection. 

The following guidance may be used for determining the appropriate corrective 

action for improper cooling. Cooked hot food may be reheated to 165 oF for 15 

seconds and the cooling process started again using a different cooling method if 

the food is:

• Above 70 oF and two hours or less into the cooling process; and

• Above 41 oF and six hours or less into the cooling process.

Cooked hot food should be discarded immediately if the food is:

• Above 70 oF and more than two hours into the cooling process; or

• Above 41 oF and more than six hours into the cooling process.

A different, more accelerated, cooling method may be used for prepared readyto-eat foods if the food is above 41 oF and less than four hours into the cooling 

process; however, such foods should be discarded if the food is above 41 oF and 

more than four hours into the cooling process.

8. Assessing Personal Hygiene, Hands As a Vehicle of Contamination, and

Proper Implementation of Employee Health Policies

Special attention should be given to the potential for hands as a vehicle of 

contamination. An effective management system for prevention of hand 

contamination involves three elements:
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Annex 5 - 24

• Employee health policy

• Proper handwashing

• No bare hand contact with ready-to-eat foods. 

There are a wide range of communicable diseases and infections that can be 

transmitted by an infected food employee. Proper management of the risks 

associated with ill food employees begins with employing healthy people and 

implementing a policy that excludes or restricts ill employees as specified in 

Chapter 2 of the Food Code. Employees must be aware of the symptoms, 

illnesses, or conditions that must be reported to the person in charge. In addition, 

the person in charge must be knowledgeable regarding the appropriate action to 

take should certain symptoms, illnesses, or conditions be reported. 

With regard to the employee health policy, inspectors should ask a series of 

open-ended questions to ascertain whether the employee health policy in place 

complies with the Food Code. The following are example questions that may be 

asked: 

• What kind of policy do you have in place for handling sick employees? 

• Is there a written policy? (Note: a written policy is not required in the Food 

Code, but having a written policy may give an indication of the formality of 

the policy being discussed.)

• Describe how managers and food employees are made knowledgeable 

about their duties and responsibilities under the employee health policy.

• Are food employees asked if they are experiencing certain symptoms or 

illnesses upon conditional offer of employment? If so, what symptoms or 

illnesses are food employees asked about? Is there a written record of this 

inquiry? 

• What are food employees instructed to do when they are sick?

• What conditions or symptoms are reported?

• What may some indicators be of someone who is working while ill? 

• When are employees restricted from working with exposed food or foodcontact surfaces? When are they excluded from working in the food 

establishment?

• For employees that are sick and cannot come to work, what policy is in 

place for allowing them to return and for notifying the regulatory authority?

Special attention should be given to the potential for hands as a vehicle of 

contamination. Ensuring that hands are washed using the proper procedure and 

at the appropriate times must be a top priority during every inspection. Data show 

that viruses can be tenacious even in the presence of good handwashing.

Inspectors should observe employee use of utensils and gloves during the 

preparation and service of ready-to-eat foods and ingredients, such as salads 

and sandwiches.
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Annex 5 - 25

If ready-to-eat food is touched with bare hands, inspectors will need to address 

several questions in order to make the appropriate on-site correction 

recommendation. The answers to the following questions should provide enough

information to determine the likelihood of occurrence of hazards transmitted by 

bare hands and should be the basis for making a recommendation for on-site 

correction: 

• Does the facility have an employee health policy to identify, restrict, and 

exclude ill employees?

• Did the employees working with the food in question effectively wash their 

hands and are handwashing facilities adequate?

• Is there an approved, alternate procedure to no bare hand contact in place 

and was it followed before the bare hand contact?

• Has there been an opportunity for the employee’s hands to become 

contaminated? 

Inspectors should examine the location of handwashing sinks in relation to where 

food is being prepared. Many jurisdictions use a basic distance measurement as 

a guideline when considering the location and number of handwashing sinks 

required in a food establishment during the plan review process. While this 

information can be used to assist with the review process, it should not be used 

as the sole basis for determining whether there are an adequate number of 

handwashing sinks or whether the handwashing sinks are conveniently located.

Special emphasis should be placed on spacing in and around fixed equipment, 

the expected staffing, and the flow of food throughout a food establishment. For 

instance, a kitchen may be 30 feet in length and 12 feet wide. Although the size 

of the kitchen may dictate only one handwashing sink using a basic distance 

measurement, if a prep table the length of the line is placed between the line and 

the handwashing sink, the handwashing sink may not be conveniently located.

Likewise, one handwashing sink located at the end of cook line is useless to 

employees working at the other end if there is limited space for employees to go 

around one another during busy periods. 

9. Assessing Compliance with Approved Procedures

When conducting certain specialized processes, variances and HACCP plans 

are required by the Code. This is because such processes carry a considerable 

risk if not conducted under strict controls. For food establishments conducting 

specialized processes, each inspection should involve a review of the written 

variance, if applicable, and the implementation of the HACCP plan to ensure that 

food safety hazards are being consistently controlled.

10. Assessing Special Requirements Related to Highly Susceptible 

Populations (HSP)
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Food establishments that serve highly susceptible populations (HSP) must 

adhere to additional requirements as specified under Part 3-8 of the Code. Every 

effort should be made to inspect such facilities during preparation, service, or 

other applicable times to assess these additional requirements as well as those 

in other sections of the Food Code.

Because those persons who are very young, elderly, or who live in a facility that 

provides custodial care are extremely vulnerable to foodborne illness because of 

age or health status, it is important that risk factors be controlled on-site in a 

timely manner. Inspections of HSP facilities should be conducted by inspectors 

knowledgeable in the control of foodborne illness risk factors who take extra care 

to assure that the most vulnerable segment of the population are not at risk. 

11. Assessing Labeling, Storage, and Use of Poisonous and Toxic 

Chemicals 

During ech inspection, the proper labeling, storage, and use of poisonous and 

toxic chemicals should be verified. Containers of poisonous or toxic materials 

and personal care items shall bear a legible manufacturer's label. Working 

containers used for storing poisonous or toxic materials such as cleaners and 

sanitizers taken from bulk supplies should be clearly and individually identified 

with the common name of the material. Only chemicals that are necessary to the 

operation and maintenance of a food establishment, such as for the cleaning and 

sanitizing of equipment and utensils and the control of insects and rodents, 

should be in the food establishment. Medicines necessary for the health of 

employees may be allowed in a food establishment, but they should be labeled 

and stored to prevent contamination of food and food-contact surfaces.

Inspectors should verify that solutions containing poisonous and toxic chemicals, 

like mop water, are discarded in an appropriate service sink to prevent 

contamination of food and food-contact surfaces. In addition, inspectors should 

check delivery trucks to verify that food is protected from chemical contamination 

during shipment. Any food that has been cross-contaminated with poisonous or

toxic chemicals should be discarded or rejected immediately. 

12. Assessing Compliance with Consumer Advisory

Inspectors should ascertain whether animal foods such as beef, eggs, fish, lamb, 

milk, pork, poultry, or shellfish are served or sold raw, undercooked, or without 

otherwise being processed to eliminate pathogens, either in ready-to-eat form or 

as an ingredient in another ready-to-eat food. Inspectors should review the menu 

or food list to verify that a consumer advisory with a disclosure and reminder is 

present as specified under § 3-603.11 of the Food Code.

In addition to reviewing the menu or food list, inspectors should ask whether raw 

or undercooked foods are served or sold routinely or seasonally. It is useful to 

know foods that are often served in this manner such as oysters-on-the half shell, 
FDA Food Code 2022 Annex 5. Conducting Risk-Based Inspections

Annex 5 - 27

hollandaise sauce, béarnaise sauce, eggnog, salad dressings, hamburgers to 

order, or sunny-side-up eggs.

H. Evaluating Basic Sanitation and Facilities (Good Retail Practices)

An important part of a risk-based, routine inspection is to review how the food 

establishment actively monitors the active managerial control of foodborne illness 

risk factors and interventions; however, overall sanitation should not be 

overlooked. Systems to control basic operational and sanitation conditions within 

a food establishment, referred to as Good Retail Practices (GRPs), are the 

foundation of a successful food safety management system. GRPs found to be 

out-of-compliance may give rise to conditions that may lead to foodborne illness, 

e.g., sewage backing up in the kitchen. Just as monitoring is required by the food 

establishment to ensure that foodborne illness risk factors are controlled and 

interventions are in place, monitoring of basic sanitation conditions in the food 

establishment allows the operator an excellent opportunity to detect weaknesses 

and initiate actions for improvement. Basic operational and sanitation programs 

must be in place to: 

• Protect products from contamination by biological, chemical, and physical 

food safety hazards

• Control bacterial growth that can result from temperature abuse during 

storage

• Maintain equipment, especially equipment used to maintain product 

temperatures. 

Examples of concerns addressed by the basic operation and sanitation programs 

mentioned above include the following:

• Pest control

• Food protection (CORE ITEM)

• Equipment maintenance 

• Water

• Plumbing

• Toilet facilities

• Sewage

• Garbage and refuse disposal

• Physical facilities. 
FDA Food Code 2022 Annex 5. Conducting Risk-Based Inspections

Annex 5 - 28

5. Achieving On-Site and Long-Term Compliance

A. Developing an Effective Compliance and Enforcement Protocol

Compliance and enforcement are essential elements of a regulatory program and 

encompass all voluntary and regulatory enforcement actions taken to achieve 

compliance with regulations. Standards 3 and 6 of the Program Standards explain 

the need of regulatory jurisdictions to establish a compliance and enforcement 

protocol that results in credible follow-up for each violation noted during an 

inspection, especially violations related to foodborne illness risk factors and Food 

Code interventions. Lack of follow-up on the part of the regulatory agency signals to 

the operator that the priority item and priority foundation item violations noted were 

not important.

The resolution of out-of-compliance foodborne illness risk factors and Food Code 

interventions must be documented in each food establishment record. The desired 

outcome of Standard 6 is an effective compliance and enforcement program that is 

implemented consistently to achieve compliance with regulatory requirements.

Compliance and enforcement options may vary depending on state and local law. It 

is essential that regulatory jurisdictions develop a written compliance and 

enforcement protocol that details the order in which both voluntary corrections may 

be taken on the part of the operator and involuntary enforcement actions are to be 

taken on the part of the regulatory authority. Involuntary enforcement actions 

include, but are not limited to, such activities as warning letters, re-inspections, 

citations, administrative fines, permit suspensions, and hearings. 

Food establishment with a history of noncompliance at a level predetermined by the 

jurisdiction or with the number of foodborne illness risk factors and interventions 

violated warranting a regulatory action, signals the need either a strong regulatory 

response or an alternate approach to compliance to protect public health, e.g., active 

managerial control, behavioral change. 

Voluntary corrections taken on the part of the operator include, but are not limited to, 

such activities as on-site corrections at the time of inspection, voluntary destruction, 

risk control plans, and remedial training. Obtaining voluntary corrections by the 

operator can be very effective in achieving long-term compliance. Voluntary 

corrections by the operator are referred to in FDA’s Regulator’s Manual as 

“intervention strategies.” Intervention strategies can be divided into two groups:

• Those designed to achieve immediate on-site correction

• Those designed to achieve long-term compliance.

Successful intervention strategies for out-of-control foodborne illness risk factors can 

be tailored to each operation’s resources and needs. This will require inspectors to 

work with the operator to identify weaknesses in the existing food safety 

management system and consulting with the operator to strengthen any weak areas 

noted.
FDA Food Code 2022 Annex 5. Conducting Risk-Based Inspections

Annex 5 - 29

B. On-site Correction 

On-site corrections are intended to achieve immediate corrective action of out-ofcontrol foodborne illness risk factors posing an immediate, serious danger to the 

consumer during the inspection. Usually these violations are "operational" rather 

than structural and can be addressed by management at the time of the inspection.

It is essential to consumer protection and to regulatory credibility for on-site 

correction to be obtained for any out-of-control foodborne illness risk factors 

before completing the inspection and leaving the food establishment.

Obtaining on-site correction conveys the seriousness of the violation to 

management. Failure to require on-site correction when an out-of-control risk factor 

has been identified implies that the risk factor has little importance to food safety.

When recommending on-site correction, effective communication regarding out-ofcontrol foodborne illness risk factors is essential and can be accomplished best by: 

• Discussing food safety concerns in words that can be easily understood by 

the person in charge and employees

• Conveying the seriousness of the out-of-control foodborne illness risk factors 

in terms of increased risk of illness or injury. 

During the discussion of inspection findings with the person in charge, inspectors

should keep the discussion focused on correction of violations that present an 

immediate danger to the consumer. Discussion of less serious code violations 

should be deferred until out-of-control foodborne illness risk factors are discussed 

and on-site correction is obtained.

In most cases, selecting the most appropriate on-site correction when out-of-control 

foodborne illness risk factors are observed will be straightforward; however, in 

instances such as improper cooling, the appropriate corrective action may be more 

complicated. Since determining on-site correction depends on a number of factors, 

an inspector may need to conduct a hazard analysis of the food in order to 

determine the appropriate course of action to take.

C. Intervention Strategies for Achieving Long-term Compliance

While on-site correction of out-of-control foodborne illness risk factors is essential to 

consumer protection, achieving long-term compliance and behavior change is 

equally important. Overcoming several misconceptions about long-term compliance 

will help in achieving a desirable change of behavior. For example, in jurisdictions 

using a 44-item inspection report in which only observed violations are marked, it is 

often taken for granted that if there are no violations marked, the foodborne illness 

risk factors are being controlled. This is not necessarily true since the observation of 

code violations is subject to many variables such as the time of day, day of the 

week, or duration of the inspection. An inspection system that records only observed 

violations rather than the actual status of all foodborne illness risk factors, such as 

whether the risk factor was in compliance, not observed, or not applicable to the 
FDA Food Code 2022 Annex 5. Conducting Risk-Based Inspections

Annex 5 - 30

operation, may be unable to detect some foodborne illness risk factors that are 

continually or cyclically out of control. 

Another misconception is that training alone will result in foodborne illness risk 

factors being controlled. While training may help, there is no guarantee that 

knowledge acquired will equate to knowledge applied in the workplace. In order for 

knowledge to translate into changed behavior, it must be reinforced and the behavior 

must be repeated for a period of time sufficient for the behavior to become an 

ingrained pattern. Another assumption is that regulatory enforcement actions such 

as citations or administrative hearings or on-site corrections alone will automatically 

result in future management control. Unfortunately, there is no assurance that any of 

these actions will result in the long-term control of foodborne illness risk factors. 

Long-term compliance may best be achieved through voluntary actions by the 

operator. If an operator supports the concept that a food safety management system 

is needed, there is a better chance that long-term compliance will be achieved. The 

following are ways operators can better ensure long-term active managerial control 

of foodborne illness risk factors.

1. Change Equipment and Layout 

Critical limits are difficult to achieve when equipment does not work properly.

Proper calibration of equipment is vital to achieving food safety. When calibration 

is unsuccessful or is not feasible, equipment should be replaced. In addition to 

equipment malfunctioning, poor equipment layout can present opportunities for 

cross contamination and must be considered. For example: 

• Hamburgers with uniform thickness and weight are not all reaching a safe 

cooking temperature in a given time. Upon examination, it is determined 

that the grill is distributing heat unevenly. A new element is installed to 

correct the problem. 

• Splash from a nearby handwashing sink is seen on a prep table. A splash 

guard is installed to prevent cross contamination from the handwashing 

sink to the prep table. 

2. Establish Buyer Specifications 

Written specifications for the goods and services purchased by a food 

establishment prevent many problems. For example: 

• Fish posing a parasite hazard and intended for raw consumption have not 

been frozen for the specified time and temperature and no freezing 

equipment is on-site at the food establishment. Buyer specifications are 

established to place the responsibility for freezing the fish on the supplier.

• Lobster tails, hamburgers, or other products cooked with a set time 

parameter on a conveyor are not reaching the proper temperature in the 

specified time because they are larger than the size for which the 
FDA Food Code 2022 Annex 5. Conducting Risk-Based Inspections

Annex 5 - 31

conveyor is calibrated. Buyer specifications are established to restrict the 

size of products received from the supplier. 

3. Develop and Implement Recipe/Process Instructions

Simple control measures integrated into recipes and processes can improve 

management control over foodborne illness risk factors. For example: 

• Process instructions that specify using color-coded cutting boards for 

separating raw animal foods from ready-to-eat products are developed to 

control the potential for cross contamination.

• Pasteurized eggs are substituted in recipes that call for raw or 

undercooked eggs to reduce the risk of foodborne illness.

• Commercially precooked chicken is used in recipes calling for cooked 

chicken such as chicken salad to reduce the risk of contaminating foodcontact surfaces and ready-to-eat food with raw chicken. 

• Pasta is chilled in an ice bath immediately after cooking and before 

apportioning into single servings. This is specified in the procedures for 

cooking spaghetti.

4. Establish First-In-First-Out (FIFO) Procedures

Product rotation is important for both quality and safety reasons. “First-In-FirstOut” (FIFO) means that the first batch of product prepared and placed in storage 

should be the first one sold or used. Date marking foods as required by the Food 

Code facilitates the use of a FIFO procedure in refrigerated, ready-to-eat, TCS 

foods. The FIFO concept limits the potential for pathogen growth, encourages 

product rotation, and documents compliance with time/temperature requirements.

5. Develop and Implement Standard Operating Procedures (SOPs) 

Following standardized, written procedures for performing various tasks ensures 

that quality, efficiency, and safety criteria are met each time the task is 

performed. Although every operation is unique, the following list contains some 

common management areas that can be controlled with SOPs:

• Personnel (disease control, cleanliness, training)

• Facility maintenance

• Sanitary conditions (general cleaning schedule, chemical storage, pest 

control, sanitization of food-contact surfaces)

• Sanitary facilities (approved water supply and testing, if applicable, 

scheduled in-house inspection of plumbing, sewage disposal, 

handwashing and toilet facilities, trash removal)

• Equipment and utensil maintenance. 
FDA Food Code 2022 Annex 5. Conducting Risk-Based Inspections

Annex 5 - 32

SOPs can also be developed to detail procedures for controlling foodborne 

illness risk factors:

• Procedures are implemented for measuring temperatures at a given 

frequency and for taking appropriate corrective actions to prevent hazards 

associated inadequate cooking. 

• Adequate handwashing is achieved by following written procedures that 

dictate frequency, proper technique, and monitoring.

6. Develop and Implement Risk Control Plans (RCPs) 

An RCP is a concisely written management plan developed by the retail or food 

service operator with input from inspectors that describes a management system 

for controlling specific out-of-control foodborne illness risk factors. An RCP is 

intended to be a voluntary strategy that inspectors and the person in charge 

jointly develop to promote long-term compliance for specific out-of-control 

foodborne illness risk factors. For example, if food is improperly cooled in the 

establishment, a system of monitoring and record keeping outlined in an RCP 

can ensure that new procedures are established to adequately cool the food in 

the future. An RCP should require that the basic control systems in the plan be 

implemented for a designated period of time (e.g., 60 – 90 days) and allow 

inspector oversight. The longer the plan is implemented, the more likely it is that 

the new controls will become "habits" that continue to be used in the food 

establishment after inspector oversight ends. 

An RCP should stress simple control measures that can be integrated into the 

daily routine. It should be brief, no more than one page for each risk factor, and 

address the following points in very specific terms:

• What is the risk factor to be controlled? 

• How is the risk factor controlled?

• Who is responsible for the control?

• What monitoring and record keeping is required?

• Who is responsible for monitoring and completing records?

• What corrective actions should be taken when deviations are noted?

• How long is the plan to continue? 

• How are the results of the RCP communicated to inspectors?

By implementing an RCP, the retail or food service operator will have the 

opportunity to determine the appropriate corrective action for the identified 

problem and design an implementation strategy to best suit the establishment 

and operation. Since the RCP is tailored to meet the needs of the food 

establishment, the operator takes complete ownership of the plan and is 

ultimately responsible for its development and implementation. The role of 
FDA Food Code 2022 Annex 5. Conducting Risk-Based Inspections

Annex 5 - 33

inspectors are to consult with the operator by suggesting ways that the risk 

factor(s) might be controlled.

By creating an RCP, the operator realizes that a problem exists in the 

established food safety management system and commits to a specific correction

plan rather than merely acknowledging a single violation. Follow up by telephone 

or in person indicates to the operator that inspectors are interested in seeing the 

plan succeed. This also gives inspectors an opportunity to answer any questions 

and offer feedback to the operator to make the RCP more useful. An example of 

an RCP, along with a blank template that can be used by regulatory jurisdictions, 

is found in FDA’s Regulator’s Manual:

http://www.fda.gov/Food/GuidanceRegulation/HACCP/ucm2006812.htm

7. Develop and Implement Comprehensive Voluntary Food Safety 

Management Systems based on HACCP Principles

The Food Code only requires HACCP plans for a few specialized processes; 

however, the development of voluntary HACCP plans is always encouraged.

FDA Operator’s Manual, "Managing Food Safety: A Manual for the Voluntary Use 

of HACCP Principles for Operators of Food Service and Retail Establishments" is 

written to aid food establishment managers in the development of food safety 

management systems based on HACCP principles. A retail or food service 

operator, in consultation with an appropriate regulatory authority or other food 

safety professional, can use this document to establish an effective food safety 

management system to control for all foodborne illness risk factors. This

document is available from FDA through the following website:

http://www.fda.gov/Food/GuidanceRegulation/HACCP/ucm2006811.htm

6. Inspection Form and Scoring

A. The Inspection Form 

The inspection form is the official document utilized by a regulatory agency for 

documentation of compliance of the food establishment with regulatory 

requirements. The goal of the inspection form is to clearly, concisely, and fairly 

present the compliance status of the food establishment and to convey compliance 

information to the permit holder or person in charge at the conclusion of the 

inspection. 

The inspection report should be kept in the food establishment's files for subsequent 

compliance actions and review before the next inspection. Individual inspection

reports are to be made available for public review in accordance with Freedom of 

Information criteria.

Annex 7 of the Food Code provides an inspection form that may be completed for 

routine, follow-up, and compliance inspections. This inspection form meets 

requirements established in Standards 3 and 6 of the Program Standards. 
FDA Food Code 2022 Annex 5. Conducting Risk-Based Inspections

Annex 5 - 34

B. Debiting Methodology 

If a violation exists during an inspection, it should always be marked on the 

inspection report, even if corrected on site. Violations existing at the time of the 

inspection probably would have persisted if it were not for the inspection. Slight 

violations, such as one dirty utensil among hundreds of clean utensils, does not 

indicate that the food establishment is significantly deviating from the Code 

requirements; therefore, discretion in marking is required.

It is very important to investigate the root causes of violations and mark them 

appropriately. Without taking this extra step, inspectors will merely point out 

violations and will not identify weaknesses in the management system in place. If 

long-term control of the behaviors or practices leading to the violations is expected, 

inspectors must identify the causes. 

C. Scoring

Regulatory agencies may use scoring methods to rate food establishments.

Depending on the system used, establishment scoring may provide an indication of 

how well a food establishment is complying with the food safety rules of the 

regulatory agency.

Some agencies use a system of compliance tools as provided in Chapter 8 and 

Annex 1 of the Food Code to protect public health. The inspection score may serve 

as the basis for triggering follow-up inspections or other forms of regulatory 

sanctions when they fall too far from the accepted levels. In addition, scoring may 

provide a mechanism for consumers to make informed choices regarding where they 

want to eat.

Use of scoring systems also has negative consequences. For example, it is possible 

for a food establishment to receive a high numerical or letter score while exhibiting 

some very serious deficiencies. In recognition of this drawback, some jurisdictions 

forego scoring systems in favor of demerits or debit systems without assigning a 

final score. This focuses attention on the items needing correction. Compliance and 

enforcement decisions can still be based on the increasing levels of identified 

deficiencies. Whatever method or system of establishment rating is used, policies 

regarding follow-up and enforcement actions should be established in writing, linked 

to the rating system, and administered consistently.

7. Closing Conference

The closing conference should include a detailed discussion of the food establishment's 

plans for correcting violations found during the inspection. The evidence collected or 

observed during the inspection and the alternatives available for compliance should be 

emphasized. On-site corrections made during the inspection should be acknowledged 

on the inspection report and in the closing conference.

The compliance plan should address changes in procedures that will prevent the 

recurrence of noted violations. The food establishment's compliance plans should be 
FDA Food Code 2022 Annex 5. Conducting Risk-Based Inspections

Annex 5 - 35

formally documented on the inspection report form. Follow-up letters may be necessary 

to elicit fulfillment of these agreements. It is important to stress to the operator that longterm correction of violations related to foodborne illness risk factors and Food Code 

interventions is far more important than corrections of core items.

8. Summary

Although a retail and food service operator has the responsibility for establishing a food 

safety management system for controlling foodborne illness risk factors, inspectors 

have a vital, multi-faceted role in consumer protection. It is essential that inspectors are 

provided with the proper training, equipment, time, and resources to adequately perform 

their jobs.

The primary role of inspectors is to ensure that the operator has effective control of 

foodborne illness risk factors. Once inspectors have established a dialogue with the 

person in charge and employees, conducted a menu/food list review, and established a 

dialogue with the person in charge, inspectors will have enough information to mentally 

place menu items into one of the three process flows. The inspection can then focus on 

assessing the operator’s active managerial control of foodborne illness risk factors 

associated with each process.

Once out-of-control foodborne illness risk factors are identified, the role of inspectors 

shifts to assisting the operator with strengthening the existing food safety management 

system through intervention strategies designed to achieve immediate and long-term 

compliance. With inspector’s assistance, a retail and food service operator can achieve 

long-term behavioral change resulting in a reduction in risk factor occurrence and an 

increase in public health protection.
FDA Food Code 2022 Annex 6: Food Processing Criteria

Annex 6 - 1

Annex 6 Food Processing 

Criteria

1. Introduction

2. Reduced Oxygen Packaging

3. Smoking and Curing

1. Introduction

From its inception, the retail segment of the food industry has prepared foods in 

consumer-sized portions, using commercially available equipment for cutting, grinding, 

slicing, cooking, and refrigeration, and applying herbs and spices readily available to 

consumers at their local grocery.

Over the past score of years, retail segment operators have expanded into food 

manufacturing/processing-type operations, often using sophisticated new technologies 

and equipment that are sometimes microprocessor-controlled. Many now desire to alter 

the atmospheres within food packages, or apply federally regulated chemical food 

additives as a method of food preservation. Food processing operations now being 

conducted or proposed include cook-chill; vacuum packaging; sous vide; smoking and 

curing; brewing, processing, and bottling alcoholic beverages, carbonated beverages, or 

drinking water; and custom processing of animals.

The Food Code specifies that a HACCP plan acceptable to the regulatory authority be 

the basis for approving food manufacturing/processing operations at retail. The HACCP 

plans are to be provided and accepted in two ways as follows.

(A) Reduced Oxygen Packaging

Section 3-502.12 of the Food Code provides the criteria that are to be met in the 

HACCP plans of those operators who are conducting reduced oxygen packaging 

(ROP) operations. Unless prior approval of the HACCP plan is required by the 

regulatory authority, the HACCP plan covering this operation along with the 

related records documenting monitoring and corrective actions need only be 

available and acceptable to the regulatory authority at the time of inspection. 
FDA Food Code 2022 Annex 6: Food Processing Criteria

Annex 6 - 2

(B) Other Food Manufacturing/Processing Operations

Except for ROP as discussed in (A) above, the Food Code specifies under §§ 3-

502.11, 8-103.10, 8-103.11, and 8-201.13 that the food establishment operator 

must obtain a variance from the regulatory authority for all food 

manufacturing/processing operations based on the prior approval of a HACCP 

plan. 

The purpose of this Annex is to provide processing criteria for different types of 

food manufacturing/processing operations for use by those preparing and 

reviewing HACCP plans and proposals. Criteria for additional processes will be 

provided as they are developed, reviewed, and accepted.

2. Reduced Oxygen Packaging

(A) Introduction

ROP which provides an environment that contains little or no oxygen, offers unique 

advantages and opportunities for the food industry but also raises many microbiological 

concerns. Products packaged using ROP may be produced safely if proper controls are 

in effect. Producing and distributing these products with a HACCP approach offer an 

effective, rational, and systematic method for the assurance of food safety. Nontime/temperature control for safety food, defined in Chapter 1, does not require a 

variance or HACCP Plan for ROP. This Annex will provide guidelines for effective food 

safety controls for retail food establishments covering the receipt, processing, 

packaging, holding, displaying, and labeling of food in reduced oxygen packages. 

(B) Definitions

The term ROP can be used to describe any packaging procedure that results in a 

reduced oxygen level in a sealed package. The term is often used because it is an 

inclusive term and can include packaging options such as:

(1) Cook-chill packaging, in which cooked food is hot filled into impermeable 

bags and are then sealed or crimped closed. The bagged food is rapidly chilled 

and refrigerated at temperatures that inhibit the growth of psychrotrophic 

pathogens.

(2) Controlled Atmosphere Packaging (CAP) in which the atmosphere of a 

package of food is modified so that until the package is opened, its composition 

is different from air, and continuous control of that atmosphere is maintained, 

such as by using oxygen scavengers or a combination of total replacement of 

oxygen, nonrespiring food, and impermeable packaging material.

(3) Modified Atmosphere Packaging (MAP) in which the atmosphere of a 

package of food is modified so that its composition is different from air but the 

atmosphere may change over time due to the permeability of the packaging 

material or the respiration of the food. Modified atmosphere packaging includes 
FDA Food Code 2022 Annex 6: Food Processing Criteria

Annex 6 - 3

reduction in the proportion of oxygen, total replacement of oxygen, or in increase 

in the proportion of other gases such as carbon dioxide or nitrogen.

(4) Sous Vide, in which raw or partially cooked food is placed in a hermetically 

sealed, impermeable bag, cooked in the bag, rapidly chilled, and refrigerated at 

temperatures that inhibit the growth of psychrotrophic pathogens.

(5) Vacuum Packaging in which air is removed from the package of food and the 

package is hermetically sealed so that a vacuum remains inside the package.

(C) Benefits of ROP

ROP can create a significantly anaerobic environment that prevents the growth of 

aerobic spoilage organisms, which generally are Gram-negative bacteria such as 

pseudomonads or aerobic yeast and molds. These organisms are responsible for offodors, slime, and texture changes, which are signs of spoilage.

ROP can be used to prevent degradation or oxidative processes in food products. 

Reducing the oxygen in and around a food retards the amount of oxidative rancidity in 

fats and oils. ROP also prevents color deterioration in raw meats caused by oxygen. An 

additional effect of sealing food in ROP is the reduction of product shrinkage by 

preventing water loss. 

These benefits of ROP allow an extended shelf life for vacuum packaged (VP), modified 

atmosphere packaged (MAP) and controlled atmosphere packaged (CAP) foods 

displayed for retail sale. Cook chill (CC) and sous vide (SV) processed food cannot be 

sold directly to consumers or other businesses but the extended shelf life and quality 

benefits internal service and use of the products. Providing an extended shelf life for 

ready-to-eat convenience foods and advertising foods as "Fresh – Never Frozen" are 

examples of economic and quality advantages. 

(D) Safety Concerns 

Use of ROP with some foods can markedly increase safety concerns. Unless 

time/temperature control for safety foods are protected inherently, simply placing them 

in ROP without regard to microbial growth will increase the risk of foodborne illnesses. 

ROP processors and regulators must assure that during distribution of foods or while 

foods are held by retailers or consumers, refrigerated temperatures must be 

consistently maintained. In fact, a serious concern is that the increased use of vacuum 

packaging at retail supermarket deli-type operations may be followed by temperature 

abuse in the establishment or by the consumer. Consequently, at least

one barrier or multiple hurdles resulting in a barrier needs to be incorporated into the 

production process for products packaged using ROP. The incorporation of several subinhibitory barriers, none of which could individually inhibit microbial growth but which in 

combination provide a full barrier to growth (the hurdle concept), is necessary to ensure 

food safety. 
FDA Food Code 2022 Annex 6: Food Processing Criteria

Annex 6 - 4

Some products in ROP contain no preservatives and frequently do not possess any 

intrinsic inhibitory barriers (such as, pH, aw, or salt concentrations) that either alone or in 

combination will inhibit microbial growth. Thus, product safety is not provided by natural 

or formulated characteristics. 

A reduced oxygen atmosphere provides the potential for growth of several important 

foodborne pathogens. Some of these pathogens such as Listeria monocytogenes are 

psychrotrophic and grow slowly at temperatures near the freezing point of foods. 

Additionally, the inhibition of the spoilage bacteria is significant because without these 

competing organisms, tell-tale signs signaling that the product is no longer fit for 

consumption will not occur. 

The use of one form of ROP, vacuum packaging, is not new. Many food products have 

a long and safe history of being vacuum packaged in ROP. However, the early use of 

vacuum packaging for smoked fish had disastrous results, causing a long-standing 

moratorium on certain uses of this technology at the retail level. 

Refrigerated Holding Requirements for Foods in ROP 

Safe use of ROP technology demands that adequate refrigeration be maintained 

during the entire shelf-life of time/temperature control for safety foods to ensure 

product safety.

Bacteria, with the exception of those that can form spores, are eliminated by 

pasteurization. However, pathogens may survive in the final product if 

pasteurization is inadequate, poor quality raw materials or poor handling 

practices are used, or post-processing contamination occurs. Even if foods that 

are in ROP receive adequate thermal processing, a particular concern is present 

at retail when employees open manufactured products and repackage them. This 

operation presents the potential for post-processing contamination by pathogens.

If products in ROP are subjected to mild temperature abuse, i.e., 5o-12oC (41o53oF), at any stage during storage or distribution, foodborne pathogens, including 

Bacillus cereus, Salmonella spp., Staphylococcus aureus, and Vibrio 

parahaemolyticus, can grow slowly. Marginal refrigeration that does not 

facilitate growth may still allow Salmonella spp., Campylobacter spp., and 

Brucella spp. to survive for long periods of time.

Published surveys indicate that refrigeration practices at retail need 

improvement. Some refrigerated products offered in convenience stores were 

found at or above 7.2oC (45oF) 50% of the time; in several cases temperatures 

as high as 10oC (50oF) were observed. Delicatessen display cases have been 

shown to demonstrate poor temperature control. Foods have been observed 

above 10oC (50oF) and above 12.8oC (55oF) in several instances. Supermarket 

fresh meat cases appear to have a relatively good record of temperature control. 

However, even these foods can occasionally be found above 10oC (50oF).

Temperature abuse is common throughout distribution and retail markets. Strict 

adherence to temperature control and shelf-life must be observed and 

documented by the establishment using ROP. Buyer specifications for 
FDA Food Code 2022 Annex 6: Food Processing Criteria

Annex 6 - 5

refrigerated distribution systems as well as internal time/temperature controls 

should be implemented by the establishment. Information on temperature control 

should also be provided to the consumer. Currently these controls are not 

extensively used. 

Control of Clostridium botulinum and Listeria monocytogenes in Reduced

Oxygen Packaged Foods

There has been an increased interest in ROP at retail using conventional 

refrigeration units for holding. Refrigerated foods packaged at retail may be 

chilled either after they are physically prepared and repackaged, or packaged 

after a cooking step. In either case Clostridium botulinum and Listeria 

monocytogenes are the pathogens of concern for ROP products. 

Clostridium botulinum is the causative agent of botulism, a severe food 

poisoning characterized by double vision, paralysis, and occasionally death. The 

organism is an anaerobic spore-forming bacteria that produces a potent 

neurotoxin. The spores are ubiquitous in nature, relatively heat-resistant, and can 

survive most minimal heat treatments that destroy vegetative cells. Certain 

strains of C. botulinum (type E and non-proteolytic types B and F), which have 

been primarily associated with fish, are psychrotrophic and can grow and 

produce toxin at temperatures as low as 3.3oC (38oF). Other strains of 

C. botulinum (type A and proteolytic types B and F) can grow and produce toxin 

at temperatures slightly above 10oC (50oF). If present, C. botulinum could 

potentially grow and render a food PACKAGED and held in ROP toxigenic because 

most other competing organisms are inhibited by ROP. Therefore, the food could 

be toxic yet appear organoleptically acceptable. 

This is particularly true of psychrotrophic strains of C. botulinum that do not 

produce tell-tale proteolytic enzymes which result in a distinct bad odor. Because 

botulism is potentially deadly, foods held in anaerobic conditions merit regulatory 

concern and vigilance.

The potential for Clostridium botulinum toxin to develop also exists when ROP 

is used after heat treatments such as pasteurization, or sous vide processing of 

foods which will not destroy the spores of C. botulinum. Mild heat treatments 

(heat shocks) in combination with ROP may actually select for C. botulinum by 

killing off competitors. If the applied heat treatment does not produce commercial 

sterility, the food requires refrigeration below 3.3oC (38oF) to prevent spore 

germination and toxin formation and ensure product safety. For this reason, sous 

vide products are frequently frozen and held in frozen storage until use.

There is a further microbial concern with ROP at retail. Processed products such 

as meats and cheeses which have undergone an adequate cooking step to kill 

L. monocytogenes can be re-contaminated when opened, sliced, and 

repackaged at retail. Thus, a simple packaging or repackaging operation can 

present an opportunity for recontamination with pathogens if strict sanitary 

safeguards are not in place. Hard and semi-soft cheeses that meet the 

Standards of Identity for those cheeses in 21 CFR 133.150 Hard cheeses, 21 
FDA Food Code 2022 Annex 6: Food Processing Criteria

Annex 6 - 6

CFR 133.169 Pasteurized process cheese and 21 CFR 133.187 Semi-soft 

cheeses may be packaged using ROP without a variance. Refer to Annex 3 

Public Health Reasons, Sections 3-501.17 and 3-501.18 for a partial list of hard 

and semi-soft cheeses.

Processors of products using ROP should build in extra safeguards if they plan to 

rely on refrigeration as the sole barrier that ensures product safety. This 

approach requires very rigorous temperature controls of products and 

refrigeration equipment. If extended shelf life is sought, a temperature of 3.3oC 

(38oF) or lower must be maintained at all times to prevent outgrowth of C. 

botulinum and the subsequent production of toxin. Listeria monocytogenes

can grow at even lower temperatures; consequently, appropriate use-by dates 

must be established. Growth barriers are provided by hurdles such as low pH, aw, 

or short shelf life, and constant monitoring of the product temperature. Any one 

hurdle, or a combination of several, may be used with refrigeration to control 

pathogenic outgrowth.

Design of Heat Processes for Foods in Reduced Oxygen Packages

Heat processes for sous vide or cook-chill operations must be designed so that, 

at a minimum, all vegetative pathogens are destroyed by a pasteurization 

process and temperature control is verified. When temperature is the only barrier 

and no other intrinsic or extrinsic factors add protection against the growth of 

foodborne pathogens and formation of toxin, the product may not be sold to other 

business entities or to the consumer in the ROP package because of the inability 

to verify temperature control. 

The National Advisory Committee on Microbiological Criteria for Foods 

(NACMCF), chartered by the U.S. Department of Agriculture (USDA) and the 

Department of Health and Human Services (DHHS), commented on the microbial 

safety of refrigerated foods containing cooked, uncured meat or poultry products 

that are packaged for extended refrigerated shelf life and are ready-to-eat or 

prepared with little or no additional heat treatment. NACMCF recommended 

guidelines for evaluating the ability of thermal processes to inactivate L. 

monocytogenes in extended shelf life refrigerated foods. Specifically, it 

recommended a proposed requirement for demonstrating that an ROP process 

provides a heat treatment sufficient to achieve a 4 decimal log reduction (4D) of 

L. monocytogenes.

Other scientific reports recommend more extensive thermal processing. Thermal 

processes for sous vide practiced in Europe are designed to achieve a 12-13 log 

reduction (12-13D) of the target organism Streptococcus faecalis. It is 

reasoned that thermal inactivation of this organism would ensure destruction of 

all other vegetative pathogens. 

Food manufacturers with adequate in-house research and development 

programs may have the ability to design their own thermal processes. However, 

small retailers and supermarkets may not be able to perform the microbiological 

challenge studies necessary to provide the same level of food safety. If a retail 
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Annex 6 - 7

establishment wishes to use an ROP process with different time-temperature 

parameters from those provided in Section 3-502.12 of the Food Code, 

microbiological inoculation studies should be performed by, or in conjunction 

with, an appropriate process authority or person knowledgeable in food 

microbiology who is acceptable to the regulatory authority.

Finally, if foods are held long enough, even under proper refrigeration, extended 

shelf life may be a problem. A study on fresh vegetables inoculated with 

L. monocytogenes, conducted to determine the effect of MAP on shelf life, 

found that MAP lengthened the time that all vegetables were considered 

acceptable, but that populations of L. monocytogenes increased during that 

extended storage.

Consumer Handling Practices and In-Home Refrigerator Temperatures

Extended shelf life provided by ROP is cause for concern because of the 

potential for abuse by the consumer. Consumers often cannot, or do not, 

maintain adequate refrigeration of time/temperature control for safety foods at 

home. Under the best of circumstances, home refrigerators can be expected to 

range between 5o and 10oC (41o-50oF). One study reported that home 

refrigerator temperatures in 21% of the households surveyed were 10oC (50oF). 

Another study reported more than 1 of 4 home refrigerators are above 7.2oC 

(45oF) and almost 1 of 10 are above 10oC (50oF). Thus, refrigeration alone 

cannot be relied on for ensuring microbiological safety after foods in ROP leave 

the establishment.

Consumers have come to expect that certain packages of foods would be safe 

without refrigeration. Low-acid canned foods have been thermally processed, 

which renders the food shelf-stable. Retort heating ensures the destruction of C. 

botulinum spores as well as all other foodborne pathogens. Yet consumers may

not understand that most products that are packaged in ROP are not 

commercially sterile or shelf-stable and must be refrigerated. A clear label 

statement to keep the product refrigerated must be provided to consumers.

The use of ROP has been extensively studied by regulators and the food industry 

over the past several years. Recommendations have been adapted from the 

Association of Food and Drug Officials "Retail Guidelines - Refrigerated Foods in 

Reduced Oxygen Packages" and New York State Department of Agriculture and 

Markets "Proposed Reduced Oxygen Packaging Regulations." As provided in the 

Food Code, some ROP operations may be conducted under provision 3-502.12 

Reduced Oxygen Packaging, Criteria. Food that is packaged by an ROP method 

under these provisions is considered safe while it is under the control of the 

establishment and, if the labeling instructions are followed, while under the 

control of the consumer. 
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Annex 6 - 8

(E) Safety Barrier Verification

The safety barriers for all ROP processed foods under a variance at retail must be 

verified in writing. Independent laboratory analysis using methodology approved by the 

regulatory authority such as official methods of the AOAC International (AOAC) can also 

be used to verify incoming product. ROP processed foods which comply with one of the 

methods in Section 3-502.12 do not require written verification.

Any changes in product formulation or processing procedures should be reflected in the 

HACCP plan and may require further product testing for validation. A record of all safety 

barrier verifications should be updated every 12 months. This record must be available to 

the regulatory authority for review at the time of inspection.

(F) USDA Process Exemption

Meat and poultry products cured at a food processing plant regulated by the U.S. 

Department of Agriculture using substances specified in 9 CFR 424, Preparation and 

Processing Operations, are exempt from the safety barrier verification requirements. 

Other ROP operations may be developed that do not meet the provisions of Section 

3-502.12 of the Code and that will require a variance and prior approval by the 

regulatory authority under Section 3-502.11. 

(G) Recommendations for ROP Without Multiple Barriers 

(1) Employee Training

If ROP is used in a food establishment, employees assigned to packaging of the 

foods must have documented proof that demonstrates familiarity with ROP 

guidelines in this Annex and the potential hazards associated with these foods. A 

description of the training and course content provided to the employees must 

either be available for review or have prior approval by the regulatory authority.

(2) Refrigeration Requirements

Refrigeration times and temperatures to inhibit C. botulinum and L. 

monocytogenes must be based on laboratory inoculation study data or follow 

one of the ROP methods in Section 3-502.12 which specifies the time and 

temperature combinations. The ROP package must be marked with a use-by 

date within either the manufacturer's labeled use-by date or as determined by the 

laboratory data, whichever comes first. Alternatively, foods packaged by ROP 

may be kept frozen if freezing is used as the declared primary safety barrier.

(3) Labeling - Refrigeration Statements

All foods offered for sale in ROP which rely on refrigeration at 5oC (41oF) or less 

as a barrier to microbial growth must bear the statement "Important - Must be 

kept refrigerated at 5oC (41oF)" or "Important - Must be kept frozen," in the case 

of foods which rely on freezing as a primary safety barrier. The statement must 

appear on the principal display panel in bold type on a contrasting background. 

Foods packaged using cook chill or sous vide processing methods which have 
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Annex 6 - 9

lower refrigeration requirements below 5oC (41oF) as a condition of safe shelf life 

must be monitored for temperature history and must not be offered for retail sale 

in the package or sold to a different business entity. The labeling statement 

regarding cold holding temperatures is not required for food packaged using cook 

chill or sous vide processing.

(4) Labeling - "Use-by date"

The shelf life of ROP foods is based on storage temperature for a certain time 

and other intrinsic factors of the food (pH, aw, cured with salt and nitrite, high 

levels of competing organisms, organic acids, natural antibiotics or bacteriocins, 

salt, preservatives, etc.). Each package of food in ROP must bear a "use-by" 

date. In some cases such as cook chill or sous vide processing when none of 

these intrinsic factors are present, a temperature lower than 3oC (38oF) must be 

the controlling factor for C. botulinum and L. monocytogenes growth and/or 

toxin formation. This “use by” date cannot exceed the number of days specified 

in one of the ROP methods in Section 3-502.12 or must be based on laboratory 

inoculation studies. The date assigned by a retail repacker cannot extend beyond 

the manufacturer's recommended expiration or "pull date" for the food. The "useby" date must be listed on the principal display panel in bold type on a 

contrasting background for any product sold to consumers. Any label on 

packages intended for consumer sale must contain a combination of a "sell-by" 

date and use-by instructions which makes it clear that the product must be 

consumed within the number of days determined to be safe as specified under 

Section 3-502.12 of the Food Code. Foods, especially fish, that are frozen before 

or immediately after packaging and remain frozen until use should bear a label 

statement, “Important, keep frozen until used, thaw under refrigeration 

immediately before use.” Raw meat and poultry packaged using ROP methods 

must be labeled with safe handling instructions found in 9 CFR 317.2(l) and 9 

CFR 381.125(b).

(H) Foods Which Require a Variance Under Code Section 3-502.11 if Packaged in 

Reduced Oxygen Atmosphere

(1) Unfrozen processed fish and smoked fish may not be packed by ROP unless retail 

food establishments have an approved variance application and HACCP plan to show 

C. botulinum spore germination and toxin production or L. monocytogenes growth will 

not occur and are inspected by the regulatory authority. Establishments packaging such 

fish products, and smoking and packing establishments, must be licensed in 

accordance with applicable law. 

(2) Soft cheeses such as ricotta, cottage cheese, cheese spreads, and combinations of 

cheese with other ingredients such as vegetables, meat, or fish at retail must be 

approved for ROP through an approved variance application and HACCP plan and be 

inspected by the regulatory authority. 

(3) Meat or poultry products which are smoked or cured at retail, except that raw food of 

animal origin which is cured in a USDA-regulated processing plant, or establishment 
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Annex 6 - 10

approved by the regulatory authority to cure these foods, may be smoked in accordance 

with approved time/temperature requirements and packaged in ROP at retail if 

approved by the regulatory authority. Smoking which meets the time/temperature 

parameters in Section 3-401.11 does not require a variance. Cold smoking where the

temperature achieved by the product is greater than 41oF requires a variance. Curing 

using nitrite or nitrate always requires a variance.

(I) Hazard Analysis and Critical Control Point (HACCP) Operation

All food establishments packaging food in a reduced oxygen atmosphere must develop 

a HACCP plan and maintain the plan at the processing site for review by the regulatory 

authority. For ROP operations, the plan must include the requirements specified under § 

8-201.14. In addition, the HACCP plan may also include:

(1) A complete description of the processing, packaging, and storage procedures 

designated as critical control points, with attendant critical limits, corrective action 

plans, monitoring and verification schemes, and records required; 

(2) A list of equipment and food-contact packaging supplies used, including 

compliance standards that may be required by the regulatory authority, i.e., a 

recognized third party equipment evaluation organization such as NSF 

International;

(3) A description of the lot identification system;

(4) A description of the employee training program;

(5) A listing and proportion of food-grade gasses used; and

(6) A standard operating procedure for method and frequency of cleaning and 

sanitizing food-contact surfaces in the designated processing area.

(J) Precautions Against Contamination at Retail

Only unopened packages of commercially processed, ready-to-eat deli meats or 

cheeses obtained from sources that comply with the applicable laws relating to food 

safety should be used for ROP packaging at retail. If it is necessary to stop packaging 

for a period in excess of one-half hour, the remainder of that product should be diverted 

for another use in the retail establishment. Cook chill products that are cooked before 

packaging (ready-to-eat) should also be protected from cross-contamination before 

being packaged.

(K) Disposition of Expired Product at Retail

Processed reduced oxygen foods that exceed the "use-by" date or manufacturer's "pull 

date" cannot be sold in any form and must be disposed of in a proper manner.
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Annex 6 - 11

(L) Dedicated Area/Restricted Access

All aspects of reduced oxygen packaging shall be conducted in an area specifically 

designated for this purpose. There shall be an effective separation to prevent cross 

contamination between raw and cooked foods. Access to processing equipment shall 

be restricted to responsible trained personnel who are familiar with the potential hazards 

inherent in food packaged by an ROP method. Some ROP procedures such as sous 

vide may require a "sanitary zone" or dedicated room with restricted access to prevent 

contamination.

(M) References

1. Association of Food and Drug Officials, 1990. Retail Guidelines - Refrigerated Foods 

in Reduced Oxygen Packages. J. Assoc. Food Drug Offic. 54(5):80-84.

2. Berang, M.E., R.E. Brackett, and L.R. Beuchat., 1989. Growth of Listeria

monocytogenes on fresh vegetables stored under controlled atmosphere. J. Food Prot. 

52:702-705.

3. Brown, W.L., 1991. Designing Listeria monocytogenes thermal inactivation studies for 

extended-shelf-life refrigerated foods. Food Technol. 45(4):152-153.

4. Bryan, F.L., L.A. Seabolt, R.W. Peterson, and L.M. Roberts, 1978. Time-temperature 

observations of food and equipment in airline catering operations. J. Food Prot. 41: 80-

92.

5. Conner, D.E., V.N. Scott, D.T. Bernard, and D.A. Kautter, 1989. Potential Clostridium

botulinum hazards associated with extended shelf-life refrigerated foods: a review. J. 

Food Safety 10:131-153.

6. Daniels, R.W., 1991. Applying HACCP to new-generation refrigerated foods at retail 

and beyond. Food Technol. 45(4):122-124.

7. Davidson, W.D., 1987. Retail store handling conditions for refrigerated foods. 

Presented at a technical session "New extended shelf-life: low-acid refrigerated foods" 

at the 80th annual convention of the National Food Processors Association. Jan. 26, 

Chicago, IL.

8. Doyle, M.P., 1991. Evaluating the potential risk from extended-shelf-life refrigerated 

foods by Clostridium botulinum inoculation studies. Food Technol. 44(4):154-156.

9. Eklund, M.W., D.I. Wieler, and F. Polsky, 1967. Growth and toxin production of 

nonproteolytic type B Clostridium botulinum at 3.3 to 5.6C. J. Bacteriol. 93:1461-1462.

10. Harris, R.D., 1989. Kraft builds safety into next generation refrigerated foods. Food 

Proc. 50(13):111-112,114.

11. Hutton, M.T., P.A. Dhehak, and J.H. Hanlin, 1991. Inhibition of botulinum toxin 

production by Pedicoccus acidilacti in temperature abused refrigerated foods. J. Food 

Safety 11:255-267.
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Annex 6 - 12

12. Kalish, F., 1991. Extending the HACCP concept to product distribution. Food 

Technol. 45(4):119-120.

13. Knabel, S.J., H.W. Walker, P.A. Hartman, and A.F. Mendonca, 1990. Effects of 

growth temperature and strictly anaerobic recovery on the survival of Listeria

monocytogenes during pasteurization. Appl. Environ. Microbiol. 56:370-376.

14. Moberg, L., 1989. Good manufacturing practices for refrigerated foods. J. Food Prot. 

52:363-367.

15. National Advisory Committee on Microbiological Criteria for Foods, 1991. Listeria 

monocytogenes. Int. J. Food Microbiol. 14:185-246.

16. National Advisory Committee on Microbiological Criteria for Foods, 1991. I HACCP 

Principles, II Meat and Poultry, III Seafood. Food Control 2(4):202-211. 

17. New York Department of Agriculture and Markets, 1993. Proposed Reduced 

Oxygen Packaging Regulations. Division of Food Safety and Inspection, 1 Winners 

Circle, Albany, NY, 12235, 6 pp.

18. Nolan, D.A., D.C. Chamberlin and J.A. Troller, 1992. Minimal water activity of 

Listeria monocytogenes and Listeria innocua. Int. J. Food Microbiol. 16:323-335.

19. Palumbo, S. A., 1986. Is refrigeration enough to restrain foodborne pathogens? J. 

Food Prot. 49:1003-1009.

20. Refrigerated Foods and Microbiological Criteria Committee of the National Food 

Processors Association, 1988. Safety considerations for new generation refrigerated 

foods. Dairy Food Sanit. 8:5-7.

21. Rhodehamel, E.J., 1992. FDA concerns with sous vide processing. Food Technol. 

46(12):73-76.

22. Schimdt, C.F., R.V. Lechowich, and J.F. Folinazzo, 1961. Growth and toxin 

production by type E C. botulinum below 40F. J. Food Sci. 26:626-630.

23. Scott, V.N., 1989. Interaction of factors to control microbial spoilage of refrigerated 

foods. J. Food Prot. 52:431-435.

24. Smith, J.P., C. Toupin, B. Gagnon, R. Voyer, P.P. Fiset, and M.V. Simpson, 1990. 

Hazard analysis critical control point approach (HACCP) to ensure the microbiological 

safety of sous vide processed meat/pasta product. Food Microbiol. 7:177-198.

25. Van Garde, S.J., and M. Woodburn, 1987. Food discard practices of householders. 

J. Am. Diet. Assoc. 87:322-329.

26. Wyatt, L.D., and V. Guy, 1980. Relationships of microbial quality of retail meat 

samples and sanitary conditions. J. Food Prot. 43:385-389. 

3. Smoking and Curing

(A) Introduction
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Annex 6 - 13

Meat and poultry are cured by the addition of salt alone or in combination with one or 

more ingredients such as sodium nitrite, sugar, curing accelerators, and spices. These 

are used for partial preservation, flavoring, color enhancement, tenderizing and 

improving yield of meat. The process may include dry curing, immersion curing, direct 

addition, or injection of the curing ingredients. Curing mixtures are typically composed of 

salt (sodium chloride), sodium nitrite, and seasonings. The preparation of curing 

mixtures must be carefully controlled. A number of proprietary mixtures which are 

uniform in composition are available. The maximum residual sodium nitrite in the 

finished product is limited to 200 ppm by the USDA Food Safety and Inspection Service 

(FSIS). A sodium nitrite concentration of 120 ppm is usually sufficient for most 

purposes. Specific requirements for added nitrite may be found in USDA regulations, 9 

CFR 424. It is important to use curing methods which achieve uniform distribution of the 

curing mixture in the meat or poultry product. 

(B) Definitions 

Cured meat and poultry can be divided into three basic categories: (1) uncomminuted 

smoked products; (2) sausages; and (3) uncomminuted unsmoked processed meats. 

(1) Uncomminuted smoked products - include bacon, beef jerky, hams, pork 

shoulders, turkey breasts, turkey drumsticks. 

(2) Sausages - include both finely ground and coarse ground products. Finely 

ground sausages include bologna, frankfurters, luncheon meats and loaves, 

sandwich spreads, and viennas. Coarse ground sausages include chorizos, 

kielbasa, pepperoni, salami, and summer sausages. 

(3) Cured sausages - may be categorized as: (1) raw, cured; (2) cooked, 

smoked; (3) cooked, unsmoked; and (4) dry, semidry, or fermented. 

(4) Uncomminuted, unsmoked processed products - include corned beef, 

pastrami, pig's feet, corned tongues. This category of products may be sold as 

either raw ready-to-cook or ready-to-eat.

(C) Incorporation of Cure Ingredients

Regardless of preparation method, cure ingredients must be distributed throughout the 

product. Cure ingredients may be introduced into sausage products during mixing or 

comminuting. Proper and thorough mixing is necessary whether the cure is added to the 

formulation in dry or solution form. Muscle cuts may be cured by immersion into a curing 

(pickle) solution. These methods depend on slow diffusion of the curing agents through 

the product. Products must be properly refrigerated during immersion curing. 

Several methods may be used to shorten curing times. These include hot immersion 

curing greater than 49oC (>120oF), injection by arterial pumping (e.g., hams), and stitch 

pumping by a series of hollow needles. If the injection method is used, injection needles 

must be frequently monitored during processing to ensure that they are not fouled or 

plugged. 
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Annex 6 - 14

Tumbling or massaging may also be used as an aid to hasten curing. Proper sanitation 

must be observed to prevent contamination during this operation. 

The dry curing method, a similar process, may also be used. In this case, curing 

ingredients are rubbed over cuts and surfaces of meat held under refrigeration. 

Precautions must include wearing sanitary gloves when meat is handled. Product 

temperature maintenance is critical.

(D) Smoking

Smoking is the process of exposing meat products to wood smoke. Depending on the 

method, some products may be cooked and smoked simultaneously, smoked and dried 

without cooking, or cooked without smoking. Smoke may be produced by burning wood 

chips or using an approved liquid smoke preparation. Liquid smoke preparations may 

also be substituted for smoke by addition directly onto the product during formulation in 

lieu of using a smokehouse or another type of smoking vessel. As with curing 

operations, a standard operating procedure must be established to prevent 

contamination during the smoking process.

(E) Fermentation and Dehydration

Meat may be fermented or dehydrated for preservation. The purpose of fermentation is 

to reduce the pH to below 4.6 and inhibit bacteria harmful to health as well as bacteria 

which can cause spoilage. Meat products may also be cured and then dehydrated to 

prevent germination and growth of bacterial spores. Many fermented and dehydrated 

meats are made without a cooking step. Sanitary practices in the production of these 

products are extremely important because Staphylococcus aureus can be introduced. 

Staphylococcus aureus produces an enterotoxin that is heat stable and thus will not 

be inactivated by subsequent cooking.

Processed pork products require treatment to destroy Trichinella spiralis. At retail, 

products which contain raw pork and which are not subsequently cooked must be 

produced from certified trichina-free pork or treated to destroy trichinae. USDA 

regulations, 9 CFR 318.10(c)(3), establish various requirements for destroying trichina 

in pork by heating, freezing, drying, or smoking.

Some fermented and dry cured products are processed without cooking. The labeling 

for these products should include instructions to the consumer to cook thoroughly 

before consumption. 

(F) Recommendations for Safe Curing of Meat and Poultry

(1) Posting of Acceptable Products

A list of products approved by the regulatory authority, or by an approved 

knowledgeable authority on curing acceptable to the regulatory authority, must 

be posted in the processing area of the establishment.
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(2) Employee Training

Employees assigned to cure meat or poultry must demonstrate familiarity with 

these guidelines and the potential hazards associated with curing foods. A 

description of the training and course content provided to the employees must be 

available for review by the regulatory authority.

(3) HACCP

A HACCP plan is needed for all curing operations. The following 

recommendations must be met to cure meat and poultry products in the 

establishment. References are available from local USDA extension offices, 

public libraries, and college or university food or meat science departments to 

develop HACCP plans for curing meat and poultry.

Critical Control Points

The following are critical control points to be addressed:

(i) Purchase of prepared cure mixes; or

(ii) If cure mixes are blended on the premises instead of acquired 

pre-mixed, mixing must be carefully controlled by using calibrated 

weighing devices.

(iii) Cure ingredients must be stored in a dry location. Cure must be 

discarded if the package is wet or appears to have been wetted.

Raw Material Handling

(i) Thawing must be monitored and controlled to ensure 

thoroughness and to prevent temperature abuse. Improperly 

thawed meat could cause insufficient cure penetration. 

Temperature abuse can cause spoilage or growth of pathogens.

(ii) Meat must be fresh. Curing may not be used to salvage meat 

that has excessive bacterial growth or spoilage. 

Formulating, Preparation and Curing

(i) A formulation and preparation procedure must be documented.

(ii) All equipment and utensils must be cleaned and sanitized.

(iii) Pieces must be prepared to uniform sizes to ensure uniform 

cure penetration. This is extremely critical for dry and immersion 

curing. 

(iv) Calibrated scales must be used to weigh ingredients.

(v) A schedule or recipe must be established for determining the 

exact amount of curing formulation to be used for a specified weight 

of meat or meat mixture.
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(vi) Methods and procedures must be strictly controlled to ensure 

uniform cure.

(vii) Mixing of curing formulation with comminuted ingredients must 

be controlled and monitored.

(viii) All surfaces of meat must be rotated and rubbed at intervals of 

sufficient frequency to ensure cure penetration when a dry curing 

method is used.

(ix) Immersion curing requires periodic mixing of the batch to 

facilitate uniform curing.

(x) The application of salt during dry curing of muscle cuts requires 

that the temperature of the product be strictly controlled between 

1.7°C (35oF) and 7.2°C (45oF). The lower temperature is set to limit 

microbial growth and the upper temperature is set for the purpose 

of ensuring cure penetration. Refer to USDA regulations 9 CFR

318.10(c)(3)(iv) for specific details on dry curing. 

(xi) Curing solutions must be discarded daily unless they remain 

with the same batch of product during its entire curing process.

(xii) Injection needles must be inspected for plugging when stitch 

pumping or artery pumping of muscle cuts is performed.

(xiii) Sanitary casings must be provided for sausage, chub or loaf 

forming.

(xiv) Casings may not be stripped for reuse in forming additional 

chubs or sausages from batch to batch.

(xv) Hot curing of bacon bellies, hams, or any other products must 

be performed at >49°C (120oF) as specified in 9 CFR 318.

Cooking and/or Smoking

(i) When smokehouses are initially installed or structurally modified, 

calibration of product heating characteristics must be ascertained 

by competent food technologists. Tests should be run with full 

range of anticipated product loading. Verification of even airflow 

and moisture should be recorded in operational records of the 

smokehouse for these various loads. 

(ii) Procedures for delivering the appropriate thermal treatment of 

cooked meats in conformance with the Food Code must be 

developed and used. (Also see 9 CFR 318.17 and 318.23 for 

USDA requirements for meat products.) A minimum of 73.9°C 

(165°F) should be used for cured poultry products. 

(iii) Cooking equipment that provides even temperature control of 

the heating medium must be used.
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(iv) Products must be adequately separated to prevent overlap in 

the cooking media whether immersed in hot water, sprayed with hot 

water, steamed, or oven heated.

(v) Calibrated temperature measuring devices must be used for 

determining internal product temperatures.

(vi) Temperature measuring device probes must be sanitized to 

prevent contaminating products when internal temperatures are 

measured.

(vii) Calibrated temperature measuring devices must be used for 

measuring temperatures of the heating medium.

(viii) Raw products must be separated from cooked products.

(ix) Time/temperature parameters of the cooking process must be 

monitored and recorded. In some processes, the heating medium 

temperature should also monitored.

Cooling

(i) Cooling must be done in accordance with recommendations in 

the Food Code or under a variance. The USDA Cooling Guideline, 

FSIS Directive 7110.3 for special procedures for cured products, 

provides specific guidance.

(ii) Written cooling procedures must be established.

(iii) Chill water used in water sprays or immersion chilling which is 

in direct contact with products in casings or products cooked in an 

impervious package must be properly chlorinated. 

(iv) Chill water temperature must be monitored and controlled.

(v) Chill water may not be reused until properly chlorinated. 

Reclaimed chill water must be discarded daily.

(vi) Product must be placed in a manner that allows chilled water or 

air to uniformly contact the product for assurance of uniform 

cooling.

(vii) Internal temperatures must be monitored during cooling by 

using calibrated temperature measuring devices.

(viii) Adequate cooling medium circulation must be maintained and 

monitored.

(ix) Temperatures of the cooling medium must be monitored and 

recorded in accordance with a written procedure.

(x) Handling of product must be minimized during cooling, peeling 

of casing, and packaging. Sanitary gloves must be used in these 

procedures.
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Annex 6 - 18

Fermentation and Drying

(i) Temperature and time must be controlled and logs must be 

maintained that record the monitoring of this process.

(ii) Humidity must be controlled by use of a humidistat. Monitoring 

of the process must be recorded in a written log.

(iii) Product must be kept separated to allow adequate air 

circulation during the process.

(iv) Use of an active and pure culture must be ensured to effect a 

rapid pH drop of the product. Use of commercially produced culture 

is necessary and the culture must be used according to the 

manufacturer's instructions.

(v) Determination of the pH of fermented sausages at the end of the 

fermentation cycle must be recorded.

(vi) Handling of products must be minimized and only done with 

sanitary gloves or sanitized utensils.

(vii) Dry (unfermented) products may not be hot smoked until the 

curing and drying procedures are completed.

(viii) Semi-dry fermented sausage must be heated after 

fermentation to a time/temperature sufficient to control growth of 

pathogenic and spoilage organisms of concern.

(4) Dedicated Area/Restricted Access

All aspects of curing operations must be conducted in an area specifically 

designated for this purpose. There must be an effective separation to prevent 

cross contamination between raw and cooked foods or cured and uncured foods. 

Access to processing equipment shall be restricted to responsible trained 

personnel who are familiar with the potential hazards inherent in curing foods.

Equipment Cleaning and Sanitizing

The procedures for cleaning and sanitization must be accomplished according to 

parts 4-6 and 4-7 of the Food Code.

(G) References

Judge, M., E. Aberle, J. Forrest, H. Hedrick, and R. Merkel, 1984. Principles of Meat 

Science. Kendall/Hunt Publishing Company, Dubuque, IA.

Price, J. and B. Schweigert, 1978. The Science of Meat and Meat Products. Food and 

Nutrition Press, Inc., Westport, CT.
FDA Food Code 2022 Annex 7: Model Forms, Guides, and Other Aids

Annex 7 -1

Annex 7 Model Forms, Guides, 

and Other Aids

Employee Health Information and Application Form For Bare Hand Contact 

Procedure

FORM 1-A Conditional Employee and Food Employee Interview

FORM 1-B Conditional Employee or Food Employee Reporting Agreement

FORM 1-C Conditional Employee or Food Employee Medical Referral

FORM 1-D Application for Bare Hand Contact Procedure

Adoption Information

FORM 2-A Adoption by Reference

FORM 2-B Adoption by Section-by-Section Reference

Inspection Information

FORM 3-A Food Establishment Inspection Report

Guide 3-B Instructions for Marking the Food Establishment Inspection Report, 

Including Food Code References for Risk Factors/Interventions and Good Retail 

Practices

Summary Information

Chart 4-A Summary Chart for Minimum Cooking Food Temperatures and Holding 

Times Required by Chapter 3

Chart 4-B Summary Chart for Minimum Food Temperatures and Holding 

TimesRequired by Chapter 3 for Reheating Foods for Hot Holding

Chart 4-C Summary Chart Ready-to-Eat, Time/temperature Control for Safety Food) 

Date Marking § 3-501.17(A) – (E) and Disposition § 3-501.18

Chart 4-D FDA Food Code Mobile Food Establishment Matrix

Summary of Changes in the 2022 FDA Food Code
FDA Food Code 2022 Annex 7: Model Forms, Guides, and Other Aids

Annex 7 -2

The documents provided in this Annex are intended to facilitate adoption of the Food Code 

and the application of its provisions as they relate to conditional employees' and food 

employees' health and to food establishment inspections.

Forms 1-A through 1-C are designed to assist those responsible for managing employees 

in order to prevent foodborne disease. The Food Code specifies that the permit holder is 

responsible for requiring conditional employees or food employees to report certain 

symptoms, diagnoses, and past illnesses, as they relate to diseases transmitted through 

food by infected workers. The conditional employee or food employee is personally 

responsible for reporting this information to the person in charge. 

Form 1-D is a user-aid for a regulatory agency when considering a request to allow bare 

hand contact with ready-to-eat food. 

Forms 2-A and 2-B can be used for the Code adoption process and Form 3-A is provided 

for use in recording HACCP information and inspectional observations and has been 

updated for consistency with changes made in the Supplement to the 2009 Food Code. 

Guide 3-B, Instructions for Marking the Food Establishment Inspection Report, Including 

Food Code References for Risk Factors/Interventions and Good Retail Practices has been 

updated to be consistent with changes made in the Supplement to the 2017 Food Code.

The major headings from the Food Establishment Inspection Report form are condensed in 

Guide 3-B to key word phrases to assist the person conducting inspections in locating the 

Food Code citation that corresponds to a given violation and recording inspectional 

observations.

Guide 3-B is intended to be used during inspections to ensure that observations of the 

provisions of the Code are not overlooked during the inspection and accurately recorded on 

the Food Code Establishment Inspection Report form.
FDA Food Code 2022 Annex 7: Model Forms, Guides, and Other Aids

Annex 7 -3

FORM 1-A Conditional Employee and Food Employee Interview 

Preventing Transmission of Diseases through Food by Infected Food Employees or Conditional Employees with 

Emphasis on Illness due to Norovirus, Salmonella Typhi (S. Typhi), Shigella spp., ShigaToxin-producing Escherichia coli 

(STEC), nontyphoidal Salmonella or Hepatitis A Virus 

The purpose of this interview is to inform conditional employees and food employees to advise the person in 

charge of past and current conditions described so that the person in charge can take appropriate steps to 

preclude the transmission of foodborne illness. 

Conditional Employee Name (print) __________________________________________________________ 

Food Employee Name (print) ________________________________________________________________ 

Address _________________________________________________________________________________ 

Telephone Daytime:__________________ Evening: _________________________________________ 

Date _____________________________________ 

Are you suffering from any of the following symptoms? (Circle one) 

If YES, Date of Onset 

Diarrhea? YES / NO __________________ 

Vomiting? YES / NO __________________ 

Jaundice? YES / NO __________________ 

Sore throat with fever? YES / NO __________________ 

Or 

Infected cut or wound that is open and draining, or lesions containing pus on the hand, wrist, an exposed body 

part, or other body part and the cut, wound, or lesion not properly covered? 

(Examples: boils and infected wounds, however small) 

YES / NO 

In the Past: 

Have you ever been diagnosed as being ill with typhoid fever (S.Typhi) YES / NO 

If you have, what was the date of the diagnosis? _________ 

If within the past 3 months, did you take antibiotics for S. Typhi? YES / NO 

If so, how many days did you take the antibiotics? ________________ 

If you took antibiotics, did you finish the prescription? ____________ YES / NO

History of Exposure: 

1. Have you been suspected of causing, or have you been exposed to, a confirmed foodborne 

disease outbreak recently? YES / NO

If YES, date of outbreak: ________________________________________________

a. If YES, what was the cause of the illness and did it meet the following criteria?

Cause: ____________________________________________________________________________

i. Norovirus (last exposure within the past 48 hours)

Date of illness outbreak __________

ii. E. coli O157:H7 infection (last exposure within the past 3 days) 

Date of illness outbreak __________

iii. Hepatitis A virus (last exposure within the past 30 days)

Date of illness outbreak __________
FDA Food Code 2022 Annex 7: Model Forms, Guides, and Other Aids

Annex 7 -4

iv. Typhoid fever (last exposure within the past 14 days)

Date of illness outbreak __________

v. Shigellosis (last exposure within the past 3 days)

Date of illness outbreak __________

b. If YES, did you: 

i. Consume food implicated in the outbreak?____________________________________________

ii. Work in a food establishment that was the source of the outbreak?_______________________

iii. Consume food at an event that was prepared by person who is ill?________________________

2. Did you attend an event or work in a setting, recently where there was a confirmed disease 

outbreak? YES / NO

If so, what was the cause of the confirmed disease outbreak? _______________________________

If the cause was one of the following five pathogens, did exposure to the pathogen meet the 

following criteria? 

a. Norovirus (last exposure within the past 48 hours) YES / NO

b. E. coli O157:H7 (or other STEC (last exposure 

within the past 3 days) YES / NO

c. Shigella spp. (last exposure within the past 3 days) YES / NO

d. S. Typhi (last exposure within the past 14 days) YES / NO

e. Hepatitis A virus (last exposure within the past 30 days) YES / NO

Do you live in the same household as a person diagnosed with Norovirus, shigellosis, typhoid fever,

hepatitis A, or illness due to E. coli O157:H7 or other STEC? 

YES / NO Date of onset of illness ______________

3. Do you have a household member attending or working in a setting where there is a confirmed 

disease outbreak of Norovirus, typhoid fever, shigellosis, STEC infection, or hepatitis A?

YES / NO Date of onset of illness ______________

Name, Address, and Telephone Number of your Health Practitioner or doctor: 

Name _________________________________________________________________________________

Address _______________________________________________________________________________

Telephone – Daytime:__________________ Evening: __________________________________________

Signature of Conditional Employee ________________________________________ Date____________

Signature of Food Employee _____________________________________________ Date____________

Signature of Permit Holder or Representative _______________________________ Date____________
FDA Food Code 2022 Annex 7: Model Forms, Guides, and Other Aids

Annex 7 -5

FORM 1-B Conditional Employee or Food Employee Reporting Agreement 

Preventing Transmission of Diseases through Food by Infected Conditional Employees or Food Employees 

with Emphasis on Illness due to Norovirus, Salmonella Typhi, Shigella spp., or Shiga toxin-producing 

Escherichia coli (STEC), nontyphoidal Salmonella or Hepatitis A Virus

The purpose of this agreement is to inform conditional employees or food employees of their 

responsibility to notify the person in charge when they experience any of the conditions listed so that 

the person in charge can take appropriate steps to preclude the transmission of foodborne illness.

I AGREE TO REPORT TO THE PERSON IN CHARGE:

Any Onset of the Following Symptoms, Either While at Work or Outside of Work, Including the Date of 

Onset:

1. Diarrhea

2. Vomiting

3. Jaundice

4. Sore throat with fever

5. Infected cuts or wounds, or lesions containing pus on the hand, wrist , an exposed body part, or other body part and the 

cuts, wounds, or lesions are not properly covered (such as boils and infected wounds, however small)

Future Medical Diagnosis:

Whenever diagnosed as being ill with Norovirus, typhoid fever (Salmonella Typhi), shigellosis

(Shigella spp. infection), Escherichia coli O157:H7 or other STEC infection, nontyphoidal Salmonella or 

hepatitis A (hepatitis A virus infection)

Future Exposure to Foodborne Pathogens: 

1. Exposure to or suspicion of causing any confirmed disease outbreak of Norovirus, typhoid fever, 

shigellosis, E. coli O157:H7 or other STEC infection, or hepatitis A.

2. A household member diagnosed with Norovirus, typhoid fever, shigellosis, illness due to STEC, or 

hepatitis A. 

3. A household member attending or working in a setting experiencing a confirmed disease outbreak 

of Norovirus, typhoid fever, shigellosis, E. coli O157:H7 or other STEC infection, or hepatitis A. 

I have read (or had explained to me) and understand the requirements concerning my responsibilities under 

the Food Code and this agreement to comply with:

1. Reporting requirements specified above involving symptoms, diagnoses, and exposure specified;

2. Work restrictions or exclusions that are imposed upon me; and

3. Good hygienic practices. 

I understand that failure to comply with the terms of this agreement could lead to action by the food 

establishment or the food regulatory authority that may jeopardize my employment and may involve legal 

action against me.

Conditional Employee Name (please print)_________________________________________________

Signature of Conditional Employee _______________________________________Date ___________

Food Employee Name (please print)______________________________________________________

Signature of Food Employee ____________________________________________Date ___________

Signature of Permit Holder or Representative ______________________________Date ___________
FDA Food Code 2022 Annex 7: Model Forms, Guides, and Other Aids

Annex 7 -6

FORM 1-C Conditional Employee or Food Employee Medical Referral 

Preventing Transmission of Diseases through Food by Infected Food Employees with Emphasis on Illness 

due to Norovirus, Typhoid fever (Salmonella Typhi), Shigellosis (Shigella spp.), Escherichia coli O157:H7 or 

other Shiga Toxin-producing Escherichia coli (STEC), nontyphoidal Salmonella and Hepatitis A Virus

The Food Code specifies, under Part 2-2 Employee Health Subpart 2-201 Disease or Medical Condition,

that Conditional Employees and Food Employees obtain medical clearance from a health practitioner licensed 

to practice medicine, unless the Food Employees have complied with the provisions specified as an 

alternative to providing medical documentation, whenever the individual:

1. Is chronically suffering from a symptom such as diarrhea; or

2. Has a current illness involving Norovirus, typhoid fever (Salmonella Typhi), shigellosis (Shigella spp.)

E. coli O157:H7 infection (or other STEC), nontyphoidal Salmonella or hepatitis A virus (hepatitis A), or

3. Reports past illness involving typhoid fever (S. Typhi) within the past three months (while salmonellosis is 

fairly common in U.S., typhoid fever, caused by infection with S. Typhi, is rare). 

Conditional Employee being referred: (Name, please print) ________________________________________ 

Food Employee being referred: (Name, please print) _________________________________________________________

4. Is the employee assigned to a food establishment that serves a population that meets the Food Code 

definition of a highly susceptible population such as a day care center with preschool-age children, a 

hospital kitchen with immunocompromised persons, or an assisted living facility or nursing home with older 

adults?

YES NO

Reason for Medical Referral: The reason for this referral is checked below: 

Is chronically suffering from vomiting or diarrhea; or (specify) ___________________________________

Diagnosed or suspected Norovirus, typhoid fever, shigellosis, E. coli O157:H7 (or other STEC) infection, 

nontyphoidal Salmonella or hepatitis A. (Specify)_____________________________________________

Reported past illness from typhoid fever within the past 3 months. (Date of illness) _____________________

Other medical condition of concern per the following description: ________________________________

Health Practitioner’s Conclusion: (Circle the appropriate one; refer to reverse side of form)

Food employee is free of Norovirus infection, typhoid fever (S. Typhi infection), Shigella spp. infection, 

E. coli O157:H7 (or other STEC infection), nontyphoidal Salmonella infection or hepatitis A virus 

infection, and may work as a food employee without restrictions. 

Food employee is an asymptomatic shedder of E. coli O157:H7 (or other STEC), Shigella spp., or 

Norovirus, and is restricted from working with exposed food; clean equipment, utensils, and linens; and 

unwrapped single-service and single-use articles in food establishments that do not serve highly 

susceptible populations. 

Food employee is not ill but continues as an asymptomatic shedder of E. coli O157:H7 (or other STEC), 

Shigella spp. and should be excluded from food establishments that serve highly susceptible populations 

such as those who are preschool-age, immunocompromised, or older adults and in a facility that provides 

preschool custodial care, health care, or assisted living. 

Food employee is an asymptomatic shedder of hepatitis A virus and should be excluded from working in 

a food establishment until medically cleared. 

Food employee is an asymptomatic shedder of Norovirus and should be excluded from working in a food 

establishment until medically cleared, or for at least 24 hours from the date of the diagnosis. 
FDA Food Code 2022 Annex 7: Model Forms, Guides, and Other Aids

Annex 7 -7

Food employee is suffering from Norovirus, typhoid fever, shigellosis, E. coli O157:H7 (or other STEC

infection), or hepatitis A and should be excluded from working in a food establishment.

 Food employee is diagnosed with an infection from nontyphoidal Salmonella and is asymptomatic and 

should be restricted from working in food establishments serving a highly susceptible population and food 

establishments not serving a highly susceptible population.

COMMENTS: (In accordance with Title I of the Americans with Disabilities Act (ADA) and to provide only the 

information necessary to assist the food establishment operator in preventing foodborne disease 

transmission, please confine comments to explaining your conclusion and estimating when the employee may 

be reinstated.) 

______________________________________________________________________________________

______________________________________________________________________________________

_______________________________________________________________________________________

_______________________________________________________________________________________

______________________________________________________________________________________

______________________________________________________________________________________

______________________________________________________________________________________

______________________________________________________________________________________

Signature of Health Practitioner____________________Date ___________________
FDA Food Code 2022 Annex 7: Model Forms, Guides, and Other Aids

Annex 7 -8

Paraphrased from the FDA Food Code for Health Practitioner’s 

Reference

From Subparagraph 2-201.11(A)(2) Organisms of Concern:

Any foodborne pathogen, with special emphasis on these 56 organisms: 

1. Norovirus 2. S. Typhi 3. Shigella spp. 4. E. coli O157:H7 (or other STEC) 5. Hepatitis A virus 6. 

Nontyphoidal Salmonella

From Subparagraph 2-201.11(A)(1) Symptoms: 

Have any of the following symptoms: 

 Diarrhea Vomiting Jaundice Sore throat with fever

From Subparagraph 2-201.11(A)(4)-(5) Conditions of Exposure of Concern:

(1) Suspected of causing a foodborne outbreak or being exposed to an outbreak caused by 

Norovirus, S. Typhi, Shigella spp., E. coli o157:H7 (or other STEC), Hepatitis A virus , at an event 

such as a family meal, church supper, or festival because the person:

Prepared or consumed an implicated food; 

or consumed food prepared by a person who is infected or ill with the organism that caused the 

outbreak or who is suspected of being a carrier; 

(2) Lives with, and has knowledge about, a person who is diagnosed with illness caused by 

Norovirus, S. Typhi, Shigella spp., E. coli o157:H7 (or other STEC), Hepatitis A virus ; or

(3) Lives with, and has knowledge about, a person who works where there is an outbreak caused by 

Norovirus, S. Typhi, Shigella spp., E. coli o157:H7 (or other STEC), Hepatitis A virus 

From Subparagraph 2-201.12 Exclusion and Restriction: 

Decisions to exclude or restrict a food employee are made considering the available evidence about the 

person=s role in actual or potential foodborne illness transmission. Evidence includes: 

Symptoms Diagnosis Past illnesses Stool/blood tests

In facilities serving highly susceptible populations such as day care centers and health care facilities, a 

person for whom there is evidence of foodborne illness is almost always excluded from the food 

establishment.

In other establishments such as restaurants and retail food stored, that offer food to typically healthy 

consumers, a person might only be restricted from certain duties, based on the evidence of foodborne 

illness. 
FDA Food Code 2022 Annex 7: Model Forms, Guides, and Other Aids

Annex 7 -9

Exclusion from any food establishment is required when the person is:

• Exhibiting or reporting diarrhea or vomiting;

• Diagnosed with illness caused by S. Typhi; or

• Jaundiced within the last 7 days. 

For Shigella spp. or Escherichia coli O157:H7 or other STEC infections, the person’s stools must be 

negative for 2 consecutive cultures taken no earlier than 48 hours after antibiotics are discontinued, and 

at least 24 hours apart or the infected individual must have resolution of symptoms for more than 7 days 

or at least 7 days have passed since the employee was diagnosed. 
FDA Food Code 2022 Annex 7: Model Forms, Guides, and Other Aids

Annex 7 -10

FORM 1-D Application for Bare Hand Contact Procedure (As specified in Food 

Code ¶ 3-301.11(E))

Please type or print legibly using black or blue ink

1. Establishment Name: ________ _________________________________________________

2. Establishment Address: _____________________________________________________________________

3. Responsible Person:_____________________ Phone: ______

Legal Representative Business

4. List Procedure and Specific Ready-To-Eat-Foods to be considered for use of bare hand contact with ready-to-eat 

foods:

_______________________ _________________________________________________________

_____________________________________________________________________________________________

______________________________________________________________________________________

5. Handwashing Facilities: 

 (a) There is a handwashing sink located immediately adjacent to the posted bare hand contact procedure and the hand sink is 

maintained in accordance with provisions of the Code. (§ 5-205.11, § 6-301.11, § 6-301.12, § 6-301.14) YES NO (Include 

diagram, photo or other information)

(b) All toilet rooms have one or more handwashing sinks in, or immediately adjacent to them, and the sinks are equipped and 

maintained in accordance with provisions of the Code. (§ 5-205.11, § 6-301.11, § 6-301.12, § 6-301.14) YES NO 

6. Employee Health Policy: The written employee health policy must be attached to this form along with 

documentation that food employees and conditional employees acknowledge their responsibilities. (§ 2-201.11, § 2-

201.12, § 2-201.13)

7. Employee Training: Provide documentation that food employees have received training in:

• The risks of contacting the specific ready-to-eat foods with bare hands

• Personal health and activities as they relate to diseases that are transmissible through food.

• Proper handwashing procedures to include how, when, where to wash, & fingernail maintenance. (§ 2-301.12, § 2-301.14, § 

2-301.15, § 2-302.11)

• Prohibition of jewelry. (§ 2-303.11)

• Good hygienic practices. (§ 2-401.11, § 2-401.12)

8. Documentation of Handwashing Practices: Provide documentation that food employees are following proper 

handwashing procedures prior to food preparation and other procedures as necessary to prevent crosscontamination during all hours of operation when the specific ready-to-eat foods are prepared or touched with bare 

hands. 
FDA Food Code 2022 Annex 7: Model Forms, Guides, and Other Aids

Annex 7 -11

9. Documentation of Additional Control Measures: Provide documentation to demonstrate that food employees 

are utilizing two or more of the following control measures when contacting ready-to-eat foods with bare hands:

 

• Double handwashing;

• Use of nailbrushes;

• Use of hand antiseptic after handwashing;

• Incentive programs such as paid leave encouraging food employees not to work when they are ill; or

• Other control measures approved by the regulatory authority.

Statement of Compliance:

I certify all of the following: All food employees are individually trained in the risks of contacting ready-to-eat foods with bare 

hands, personal health and activities as they relate to diseases that are transmissible through food, proper handwashing 

procedures, prohibition of jewelry, and good hygienic practices. A record of this training is kept on site. I understand that bare hand 

contact with ready-to-eat food is prohibited except for those items listed in section four (4) above. A handwashing sink is located 

immediately adjacent to the posted bare hand contact procedure. All handwashing sinks are maintained with hot water, soap, and 

drying devices. I understand that documentation is needed for handwashing practices and additional control measures. I understand 

that records to document handwashing are kept current and kept on site. 

SIGNATURE: ___________ DATE ____________________

(Signature of legal representative of the facility listed above)

Regulatory Authority (RA) Use Only:

Permit Number: _____________________________________________________

File Review Conducted on History of Handwashing Compliance: □ Yes □ No

Site Visit Conducted □ Yes □ No Comments: __________________________________

□ Approved: Effective Date: _______________ RA name ______________________________

 
FDA Food Code 2022 Annex 7: Model Forms, Guides, and Other Aids

Annex 7 -12

FORM 2-A Adoption by Reference

This "short form" may be used by governmental bodies adopting the Food Code where authorized 

by law. Use of the adoption by reference form may substantially reduce the cost of publishing and 

printing.

The description of the Food Code, below, includes Chapter 8 and the Chapter 8 annex (Annex 1). 

Modifications to the description may be necessary, based on what provisions are being adopted 

and whether they are being adopted as law or regulation.

Section 2 lists provisions that may require modifications to be consistent with existing law or that 

require insertion of dollar amounts.

(JURISDICTION) FOOD CODE

(statute/regulation/ordinance) Number

ADOPTING THE 2009 EDITION OF THE "FOOD CODE" REGULATING THE RETAIL 

SALE, COMMERCIAL AND INSTITUTIONAL SERVICE, AND VENDING OF FOOD; 

DEFINING PERMIT HOLDER, PERSON IN CHARGE, EMPLOYEE, FOOD, 

TIME/TEMPERATURE CONTROL FOR SAFETY FOOD, FOOD ESTABLISHMENT, 

SAFE MATERIAL, SANITIZATION, AND OTHER TERMS; AND PROVIDING 

STANDARDS FOR EMPLOYEE FOOD SAFETY KNOWLEDGE, HEALTH, AND 

PRACTICES; FOOD SOURCES, PREPARATION, HOLDING TEMPERATURES, AND 

PROTECTION; EQUIPMENT DESIGN, CONSTRUCTION, INSTALLATION, 

CLEANING, AND SANITIZATION; WATER, AND LIQUID AND SOLID WASTES; 

FACILITIES CONSTRUCTION AND MAINTENANCE, AND STORAGE AND USE OF 

POISONOUS AND TOXIC MATERIALS; REQUIRING A PERMIT TO OPERATE A 

FOOD ESTABLISHMENT; AND PROVIDING FOR THE RESTRICTION OR 

EXCLUSION OF EMPLOYEES, THE EXAMINATION AND CONDEMNATION OF 

FOOD, AND THE ENFORCEMENT OF THIS CODE INCLUDING THE SETTING OF 

PENALTIES. 

The (governing body) of the (jurisdiction) does ordain as follows:

SECTION 1. ADOPTION OF FOOD CODE

That a certain document, three copies of which are on file in the office of the (jurisdiction's keeper of 

records) of the (type of jurisdiction) of (name of jurisdiction) being marked and designated as the 

Food Code, 2009 Recommendations of the United States Public Health Service/Food and Drug 

Administration as published by the U.S. Department of Health and Human Services, Public Health 

Service, Food and Drug Administration be, and is hereby adopted as, the Food Code of (type of 

jurisdiction) of (name of jurisdiction) in the State of (state name); for regulating the design, 

construction, management, and operation of food establishments, and providing for plans submission and 

approval and the issuance of permits and collection of fees therefore.
FDA Food Code 2022 Annex 7: Model Forms, Guides, and Other Aids

Annex 7 -13

SECTION 2. INSERTIONS AND CHANGES

That the following provisions are hereby revised as follows:

Paragraph 8-911.10(B)(1) and (2) Insert (Dollar Amount)

Paragraph 8-913.10(B) Insert (Dollar Amounts)

Subparagraph 8-911.10(B)(2) Insert (Number of Year(s))

SECTION 3. INCONSISTENT CODES REPEALED

That (statute/regulation/ordinance) number (present code number) of the (jurisdiction) titled, 

(complete title of the food code[s] in effect at the present time so they will be repealed by definite 

mention)

and all other codes or portions of codes in conflict herewith are hereby repealed in that respect only.

SECTION 4. CERTIFICATION OF ADOPTION AND PUBLISHING 

That the (jurisdiction's keeper of records) shall certify the adoption of this

(statute/regulation/ordinance and cause the same to be published as required by law. 

SECTION 5. EFFECTIVE DATE

That this Code and the rules, regulations, provisions, requirements, orders, and matters established and

adopted hereby shall take effect and be in full force and effect (time period) from and after the date of

its final passage and approval.

PASSED AND APPROVED BY (name of adopting authority) on this (day) of (month, year) .

BY: 

Examples of how some jurisdictions have set fines, sentences, and penalties:

1. California law provides:

A. For Wholesale Food Violations:

Criminal fines and sentence for violations of up to $1,000 and up to one year imprisonment if 

there is shown an intent to defraud or mislead, and

Civil penalties of up to $1,000 per day for certain violations. 

B. For Retail Food Violations: 

Criminal fines and sentence for violations of not less than twenty-five dollars ($25) or more than 

one thousand dollars ($1000) for each offense, or by imprisonment in the county jail for a term not 

exceeding six months, or by both such fine and imprisonment. 
FDA Food Code 2022 Annex 7: Model Forms, Guides, and Other Aids

Annex 7 -14

2. Maryland law provides:

Criminal fines and sentence for certain misdemeanors of up to $10,000 and one year 

imprisonment, and in the case of repeat code violation convictions, up to $25,000 and three

years imprisonment; and 

Civil penalties of up to $5,000 for each violation and for each day the violation continues.

3. Texas law provides:

Criminal fines and sentence for certain violations of up to $10,000 and two years imprisonment; 

and 

Assessment of five "severity" levels of administrative or civil penalties with base amounts ranging 

from $1,250 through $10,000. Base amounts can be decreased or increased by as much as 50% 

considering factors such as past performance, good faith, direct impact on health and safety, 

high-risk populations involved, etc. 

Though rarely used with retail food establishments, Federal law provides under the Criminal Fine 

Enforcement Act of 1984 for a fine up to $100,000 for a misdemeanor by a corporation or 

individual not resulting in death and, for misdemeanors resulting in death, a fine of up to $250,000

for individuals and $500,000 for corporations. 
FDA Food Code 2022 Annex 7: Model Forms, Guides, and Other Aids

Annex 7 -15

FORM 2-B Adoption by Section-by-Section Reference 

This "long form" may be used by governmental bodies adopting the Food Code 

section-by-section.

The description of the "Food Code," below, includes Chapter 8 and the Chapter 8 

annex

(Annex 1). Modifications to the description may be necessary, based on what 

provisions are being adopted and whether they are being adopted as law or 

regulation.

Section 2 lists provisions that may require modifications to be consistent with 

existing law or that require insertion of dollar amounts.

(JURISDICTION) FOOD CODE

(statute/regulation/ordinance) Number

ADOPTING A CODE REGULATING THE RETAIL SALE, COMMERCIAL AND INSTITUTIONAL 

SERVICE, AND VENDING OF FOOD; DEFINING PERMIT HOLDER, PERSON IN CHARGE, 

EMPLOYEE, FOOD, TIME/TEMPERATURE CONTROL FOR SAFETY FOOD, FOOD 

ESTABLISHMENT, SAFE MATERIAL, SANITIZATION, AND OTHER TERMS; AND PROVIDING 

STANDARDS FOR EMPLOYEE FOOD SAFETY KNOWLEDGE, HEALTH, AND PRACTICES; FOOD 

SOURCES, PREPARATION, HOLDING TEMPERATURES, AND PROTECTION; EQUIPMENT DESIGN, 

CONSTRUCTION, INSTALLATION, CLEANING AND SANITIZATION; WATER, AND LIQUID AND 

SOLID WASTES; FACILITIES CONSTRUCTION AND MAINTENANCE, AND STORAGE AND USE OF 

POISONOUS AND TOXIC MATERIALS; REQUIRING A PERMIT TO OPERATE A FOOD 

ESTABLISHMENT; AND PROVIDING FOR THE RESTRICTION OR EXCLUSION OF EMPLOYEES, 

THE EXAMINATION AND CONDEMNATION OF FOOD, AND THE ENFORCEMENT OF THIS CODE 

INCLUDING THE SETTING OF PENALTIES. 

The (governing body) of the (jurisdiction) does ordain as follows:

(REPRINT THE FOOD CODE, (date) RECOMMENDATIONS OF THE UNITED STATES PUBLIC

HEALTH SERVICE/FOOD AND DRUG ADMINISTRATION, SECTION-BY-SECTION)

SECTION 2. INSERTIONS AND CHANGES

That the following provisions may need to be completed as follows:

Paragraph 8-911.10(B)(1) and (2) Insert (Dollar Amount)

Paragraph 8-913.10(B) Insert (Dollar Amounts)

Subparagraph 8-911.10(B)(2) Insert (Number of Year(s))
FDA Food Code 2022 Annex 7: Model Forms, Guides, and Other Aids

Annex 7 -16

SECTION 3. INCONSISTENT CODES REPEALED

That (statute/regulation/ordinance) number (present code number) of the (jurisdiction) titled, (complete title of the 

food code[s] in effect at the present time so they will be repealed by definite mention) and all other codes or portions 

of codes in conflict herewith are hereby repealed in that respect only.

SECTION 4. CERTIFICATION OF ADOPTION AND PUBLISHING 

That the (jurisdiction's keeper of records) shall certify the adoption of this (statute/regulation/ordinance) and 

cause the same to be published as required by law. 

SECTION 5. EFFECTIVE DATE

That this Code and the rules, regulations, provisions, requirements, orders, and matters established and adopted 

hereby shall take effect and be in full force and effect (time period) from and after the date of its final passage and 

approval.

PASSED AND APPROVED BY (name of adopting authority) on this (day) of (month, year) .

BY:

Examples of how some jurisdictions have set fines, sentences, and penalties:

1. California law provides:

A. For Wholesale Food Violations:

Criminal fines and sentence for violations of up to $1,000 and up to one year imprisonment if 

there is shown an intent to defraud or mislead, and

Civil penalties of up to $1,000 per day for certain violations. 

B. For Retail Food Violations: 

Criminal fines and sentence for violations of not less than twenty-five dollars ($25) or more than 

one thousand dollars ($1000) for each offense, or by imprisonment in the county jail for a term not 

exceeding six months, or by both such fine and imprisonment. 

2. Maryland law provides:

Criminal fines and sentence for certain misdemeanors of up to $10,000 and one year 

imprisonment, and in the case of repeat code violation convictions, up to $25,000 and three

years imprisonment; and 

Civil penalties of up to $5,000 for each violation and for each day the violation continues.

3. Texas law provides:

Criminal fines and sentence for certain violations of up to $10,000 and two years imprisonment; 

and 
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Assessment of five "severity" levels of administrative or civil penalties with base amounts ranging 

from $1,250 through $10,000. Base amounts can be decreased or increased by as much as 50% 

considering factors such as past performance, good faith, direct impact on health and safety, 

high-risk populations involved, etc. 

Though rarely used with retail food establishments, Federal law provides under the Criminal Fine 

Enforcement Act of 1984 for a fine up to $100,000 for a misdemeanor by a corporation or 

individual not resulting in death and, for misdemeanors resulting in death, a fine of up to $250,000

for individuals and $500,000 for corporations.
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FORM 3-A Food Establishment Inspection Report

The food establishment inspection report is the official regulatory authority document 

regarding compliance of the establishment with agency requirements. The goal of the 

report is to clearly, concisely, and fairly present the compliance status of the 

establishment and to convey compliance information to the permit holder or person in 

charge at the conclusion of the inspection. The Food Establishment Inspection Report 

form is provided as a model for use during routine, follow-up, and investigative 

inspections.

Refer to Annex 5 for further information. 
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Form 3-A
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Guide 3-B Instructions for Marking the Food Establishment Inspection Report, 

Including Food Code References for Risk Factors/Interventions and Good Retail 

Practices

Guide 3-B is intended to be used during inspections to ensure that observations of the 

provisions of the Code are not overlooked during the inspection and accurately 

recorded on the Food Code Establishment Inspection Report form. 

The major headings from the Food Establishment Inspection Report form are 

condensed in Guide 3-B into key word phrases to assist the person conducting 

inspections in locating the Food Code citation that corresponds to a given violation and 

recording inspectional observations. The risk designations (Priority (P), Priority 

Foundation (Pf) and Core (C)) have been added to each applicable code section for

reference when recording observations in the inspection report.

All references and code sections in these marking instructions are based on the 2009 Food Code and its 

Supplement.

A. GENERAL MARKING INSTRUCTIONS

Header Information

Field Description

Establishment Complete this section using the “usual/common name” or “Doing 

Business As” name of the business. This information should be the 

same as the license/permit application completed at the initiation of 

the business.

Address Street address of the actual business location

Zip Code Zip code of the actual business location

Telephone Contact phone number for the establishment

License/Permit # License number or tracking identification

Permit Holder Name of Owner or Operator as shown on application

Purpose The reason for the inspection – routine, re-inspection, complaint, or 

follow-up,etc.

Est. Type Description or code for describing the type of facility (e.g. restaurant, 

market, vehicle, temporary food facility)

Risk Category Designation of risk/priority level for determining frequency of 

inspection

Number of Risk Factor / 

Intervention Violations

The number of boxes marked OUT in items 1-29 should be counted 

and the total number placed here

Number of Repeat Risk Factor / 

Intervention Violations

The number of boxes marked R (repeat) in items 1-29 should be 

counted and the total number placed here

Score (optional) A score is optional for this form. If a jurisdiction has a scoring system, 

it should be incorporated into the inspection form and the score of an 

inspection placed here.
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Field Description

Date The date of the inspection including month, day, and year

Time In The actual time the inspection begins

Time Out The actual time the inspection ends

B. RISK FACTORS AND INTERVENTIONS

Risk factors are food preparation practices and employee behaviors most commonly reported to the 

Centers for Disease Control and Prevention (CDC) as contributing factors in foodborne illness outbreaks. 

Risk factors include: Food from Unsafe Sources, Improper Holding Temperatures, Inadequate Cooking, 

Contaminated Equipment, and Poor Personal Hygiene. These items are prominent on the Food 

Establishment Inspection Report because maintaining these items in compliance is vital to preventing 

foodborne illness. Additionally, five key public health interventions were introduced in the 1993 Food 

Code that supplemented the other interventions long-established by the Food and Drug Administration 

(FDA) model codes and guidances to protect consumer health. The five key interventions are: 

Demonstration of Knowledge, Employee Health Controls, Controlling Hands as a Vehicle of 

Contamination, Time and Temperature Parameters for Controlling Pathogens, and the Consumer 

Advisory. 

For each item on the inspection report form in the Foodborne Illness Risk Factors and Public Health 

Interventions section, the inspector should indicate one of the following for COMPLIANCE STATUS: “IN” 

which means that the item is in compliance; “OUT” which means that the item is not in compliance;

“N.O.” which means that the item was not observed during the inspection; or “N.A.” which means that 

the item is not applicable for the facility. If N.A. or N.O. is not listed as an option for a particular item, this 

means that this item must be evaluated during the inspection and a compliance status must be 

determined. If the item is marked “OUT”, document details of each violation for the item number in 

the “Observations and Corrective Actions” section on the second page of the inspection report.

Compliance status should be determined as a result of observations that establish a pattern of noncompliance. Consideration should be given to the seriousness of the observation with regard to 

prevention of foodborne illness.

For items marked “OUT,” further indicate the status of the violation by marking an “X” in the 

corresponding box for Corrected On-Site (COS) during the inspection and/or Repeat violation (R). 

Marking COS indicates that all violations cited under that particular item number have been corrected and 

verified before completing the inspection. The actual corrective action taken for each violation should be 

documented in the “Observations and Corrective Actions” section of the inspection report. For example, 

Item #10 Handwashing sink is marked out of compliance because the establishment does not have soap 

and paper towels at the handwashing sink. The person in charge partially corrects the problem by putting 

soap at the sink, but does not replace the paper towels or provide any other effective means for drying 

hands. The corrective action taken for the soap is documented in the narrative on the form, but COS is 

not marked for Item #10 because all violations under that item were not corrected. Marking R indicates 

that the same violation under a particular item number was cited on the last inspection report. Using the 

same scenario, on the subsequent inspection if the provision of soap and paper towels is not in violation, 

but employees are not washing hands in the correct sink (which is also cited under Item #8 Handwashing 

sink), R would not be marked because this is a new violation which was not cited on the previous 

inspection report.
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C. Marking Instructions for each RISK FACTOR AND INTERVENTION on the

Inspection Report

Supervision

1. PIC present, demonstrates knowledge, and performs duties

IN/OUT This item must be marked IN or OUT of compliance. The person in charge (PIC) has three 

assigned responsibilities – Presence; Demonstration of Knowledge; and Duties. This item is 

marked OUT of compliance if any one of the responsibilities is not met. 

A. Person in charge is present. This item is marked OUT of compliance if there is no PIC 

per 2-101.11(A) and (B). 

B. Demonstration of Knowledge. The PIC has three options for demonstrating knowledge. 

This item is marked IN compliance if the PIC meets at least one of the options. The three 

options for demonstration of knowledge allowed by the Food Code are:

1. Certification by an ACCREDITED PROGRAM as specified in 2-102-20. 

2. Complying with this Code by having no violations of priority items during the current 

inspection; or

3. Correct responses to the inspector's questions regarding public health practices and 

principles applicable to the operation. The inspector should assess this item by 

asking open-ended questions that would evaluate the PIC's knowledge in each of the 

areas enumerated in ¶ 2-102.11(C)(1), (4)-(16). Questions can be asked during the 

initial interview, menu review, or throughout the inspection as appropriate. The 

Inspector should ask a sufficient number of questions to enable the inspector to make 

an informed decision concerning the PIC's knowledge of the Code requirements and 

public health principles as they apply to the operation. The dialogue should be 

extensive enough to reveal whether or not that person is enabled by a clear 

understanding of the Code and its public health principles to follow sound food safety 

practices and to produce foods that are safe, wholesome, unadulterated, and 

accurately represented. 

C. Duties of the PIC. This item must be marked IN or OUT of compliance based on the 

interaction and observation with the PIC and food employee. The inspector needs to 

determine the systems or controls the PIC has put into practice regarding oversight 

and/or routine monitoring of the Duties listed in § 2-103.11. This is accomplished by 1) 

discussion with the PIC, and 2) verified through observation that the systems or controls 

are actually being implemented. This concept is commonly referred to as Active 

Managerial Control. This item must be marked OUT of compliance when there is a 

pattern of non-compliance and obvious failure by the PIC to ensure employees are 

complying with the duties listed in § 2-103.11. Since marking this item out of compliance 

requires judgment, it is important that this item not be marked for an isolated incident, but 

rather for an overall evaluation of the PIC's ability to ensure compliance with the duties 

described in § 2-103.11.

N.A. This item may be marked N.A. if the establishment is deemed by the Regulatory Authority to not 

apply due to the minimal risk of causing, or contributing to foodborne illness based on the nature 

of the operation and extent of the food operation.

N.O. Do Not Mark this item N.O.
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Applicable Code Section: 

2-101.11 Assignment (Pf)

2-102.11(A), B) and (C)(1), (4)-(16) Demonstration (Pf)

2-103.11 (A)-(O) and (Q) Person-In-Charge-Duties (Pf)

2. Certified Food Protection Manager

IN/OUT This item must be marked IN or OUT of compliance. This item is marked IN compliance 

when it is observed that the person in charge is a certified food protection manager. This 

item is marked OUT when it is observed that there is no person in charge that is deemed 

a certified food protection manager or the certified food protection manager certificate is 

deemed not to be from an accredited program. 

N.A. This item may be marked N.A. if the establishment is deemed by the Regulatory Authority 

to not apply due to the minimal risk of causing, or contributing to foodborne illness based 

on the nature of the operation and extent of food operation. 

N.O. Do NOT MARK this item N.O.

Applicable Code Section:

2-102.12(A) Certified Food Protection Manager (C)

Employee Health/Responding to Contamination Events

3. Management and food employee knowledge, and conditional employee; responsibilities and 

reporting. 

IN/OUT This item must be marked IN or OUT of compliance. This item is marked IN compliance when 

the following criteria are met: 

1. The PIC is aware of his or her responsibility to inform food employees and conditional employees 

of their responsibility to report certain symptoms or diagnosed diseases to the person in charge 

and for the PIC to report to the regulatory authority as specified under Food Code ¶ 2-103.11 (O)

and ¶¶ 2-201.11 (A),(B), (C), and (E); and

2. The PIC provides documentation or otherwise satisfactorily demonstrates during the inspection, 

that all food employees and conditional employees are informed of their responsibility to report to 

management information about their health and activities as it relates to diseases that are 

transmissible through food, as specified under ¶ 2-201.11(A). Satisfactory compliance may be 

documented by completion of Form 1-B, Conditional Employees or Food Employees Reporting 

Agreement, in Annex 7 of the 2009 Food Code for each employee or other similar State or local 

form containing the same information; or

3. In lieu of Form 1-B, compliance may be demonstrated by: 

a) Presenting evidence such as a curriculum and attendance rosters documenting that each 

employee has completed a training program which includes all the information required 

on Form 1-B regarding their reporting responsibilities; or

b) Implementation of an employee health policy which includes a system of employee 

notification using a combination of training, signs, pocket cards, or other means to convey 

all of the required information on Form 1-B to all food employees and conditional 
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employees. A signed acknowledgement by the employee should be part of any employee 

health policy. 

The regulatory authority is encouraged to establish a policy of selecting one employee at random 

during each inspection and requesting the PIC verify, by one of the previously listed methods, 

that the selected employee has been informed of his or her responsibility to report symptoms, 

exposures, and diagnosed illnesses to management. The PIC is not expected to quote symptoms 

and diseases from memory, but should be able to locate that information on Form 1-B or similar 

documents used to demonstrate compliance. 

Additional information is provided in Annex 3 of the Public Health Reasons for Subpart 2-201, 

including a number of questions, which may be used as a reference to assist the regulatory 

authority in determining compliance with this item. 

N.A. Do Not Mark this item N.A.

N.O. Do Not Mark this item N.O.

Applicable Code Sections: 

2-102.11(C)(2),(3) and (17) Demonstration (Pf)

2-103.11 (P) Person in Charge-Duties (Pf)

2-201.11(A), (B), (C), & (E) Responsibility of Permit Holder, Person in Charge, and 

Conditional Employees (P,Pf)

4. Proper use of restriction and exclusion 

IN/OUT This item must be marked IN or OUT of compliance. Compliance must be based on first hand 

observations or information and cannot be based solely on responses from the PIC to 

questions regarding hypothetical situations or knowledge of the Food Code. This item is 

marked IN when the following criteria are observed at the time of the inspection:

• There are no ill employees. 

• There are no employees experiencing symptoms with or without a diagnosis that 

require reporting, or reason for the PIC to exclude or restrict an employee 

• A food employee who works in a food establishment serving a HSP or non-HSP, is 

restricted due to diagnoses with an infection from nontyphoidal Salmonella and is 

asymptomatic

This item should be marked OUT of compliance when:

• The inspector observes a working employee with specific reportable symptoms 

(subparagraph 2-201.11 (A)(1)); or

• The inspector becomes aware that an employee has reported information about his 

or her health and activities as it relates to diseases that are transmissible through 

food and the PIC has not acted to restrict/exclude an employee as required by the 

Food Code (§2-201.12 & §2-201.13); or

• The inspector becomes aware that the PIC has not notified the Regulatory Authority 

that an employee is jaundiced or diagnosed with an illness due to a pathogen as 

specified under subparagraphs 2-201.11 (A)(2)(a)-(f) of the Food Code.

• There are food employees working in the food establishment that have been 

diagnosed with an illness as specified in paragraphs 2-201.11(A)(2-5); Additionally, in 

food establishments exclusively serving a highly susceptible population, there are to 
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be no food employees with an active sore throat with a fever working in the food 

establishment.

N.A. Do Not Mark this item N.A.

N.O. Do Not Mark this item N.O. 

Applicable Code Sections: 

2-201.11 (D) and (F) Responsibility of Permit Holder, Person in Charge, and Conditional 

Employees Responsibility of the PIC to Exclude or Restrict (P,)

2-201.12 Exclusions & Restrictions (P)

2-201.13 Removal, Adjustment, or Retention of Exclusions & Restrictions (P)

5. Clean-up of Vomiting and Diarrheal Events

IN/OUT This item should be marked IN or OUT of compliance. This items is marked IN compliance

when it is demonstrated that the food establishment has written procedures available for 

employees to follow when responding to vomiting or diarrheal events that involve the 

discharge of vomitus or fecal matter onto surfaces in the food establishment. Refer to the 

Public Health Reasons (§2-501.11 Clean up of Vomiting and Diarrheal Events) for suggested 

recommendations as to what the food establishment can include within their plan (this is not 

an exhaustive list).

This item is marked OUT of compliance if the establishment does not demonstrate the ability 

to provide written procedures for employees to follow when responding to vomiting or diarrheal 

events that involve the discharge of vomitus or fecal matter onto surfaces in the food 

establishment.

N.A. Do Not Mark this item N.A.

N.O. Do Not Mark this item N.O.

Applicable Code Section:

2-501.11 Clean-up of Vomiting and Diarrheal Events (Pf)

Good Hygienic Practices

6. Proper eating, tasting, drinking, or tobacco products use

IN/OUT This item should be marked IN or OUT of compliance based on direct observations or 

discussions of the appropriate hygienic practices of food employees. This item should be 

marked IN compliance when a food employee is observed drinking from a closed beverage 

container subsequently stored on a non-food-contact surface and separate from exposed 

food, clean equipment, and unwrapped single- service and single-use articles. This item 

should be marked OUT of compliance when food employees are observed improperly tasting 

food, eating, drinking, or using tobacco products, or there is supporting evidence of these 

activities taking place in non-designated areas of the establishment. An open container of 

liquid in the kitchen preparation area does not necessarily constitute marking this item OUT. 

Further discussion with a food employee or the PIC may be needed to determine if the liquid, if 

labeled, is used as an ingredient in food, or may be an employee beverage that is consumed 

in another designated area. If the liquid is an open beverage that is consumed in a designated 
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area, it must still be stored in a manner to prevent the contamination of food, equipment, 

utensils, linens and single-service/single-use articles. 

N.A. Do Not Mark this item N.A.

N.O. This item may be marked N.O. for retail operations only in the RARE case when there are no 

food workers present at the time of inspection.

Applicable Code Sections: 

2-401.11 Eating, Drinking, or Using Tobacco Products (C)

3-301.12 Preventing Contamination When Tasting (P)

7. No discharge from eyes, nose, and mouth

IN/OUT This item should be marked IN or OUT of compliance based on direct observations of food 

employees. This item should be marked IN compliance when no food employees are observed 

having persistent sneezing, coughing, or a runny nose that causes discharge from the eyes, 

nose or mouth. This item should be marked OUT of compliance when a food employee has 

persistent sneezing, coughing, or a runny nose that causes discharges from the eyes, nose or 

mouth, subjecting food and food-contact surfaces to potential contamination. 

N.A. Do Not Mark this item N.A.

N.O. This item may be marked N.O. for retail operations only in the RARE case when there are no 

food workers present at the time of inspection.

Applicable Code Sections: 

2-401.12 Discharges from the Eyes, Nose, and Mouth (C) 

Control of Hands as a Vehicle of Contamination

8. Hands clean and properly washed

IN/OUT This item should be marked IN or OUT of compliance. This item is marked IN compliance only 

when employees are observed using proper handwashing techniques at appropriate times and 

places. Hands are not required to be washed between each change of gloves, if it is observed 

that there was no change in the task being performed and no activities which could potentially 

result in cross contamination.

N.A. Do Not Mark this item N.A.

N.O. This item may be marked N.O. for retail operations only in the RARE case when there are no 

food workers present at the time of inspection. (If there are no food workers present, but the 

PIC accompanies the inspector on the inspection and touches food, clean equipment, or 

utensils without washing his/her hands, this item is marked OUT.)
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Applicable Code Sections: 

2-301.11 Clean condition-Hands and Arms (P)

2-301.12 Cleaning Procedure (P)

2-301.14 When to Wash (P)

2-301.15 Where to Wash (Pf)

2-301.16 Hand Antiseptics (Pf)

9. No bare hand contact with RTE foods or a pre-approved alternate properly followed

IN/OUT This item should be marked IN or OUT of compliance. This item is marked IN compliance only when food 

employees are observed using suitable utensils or gloves to prevent bare hand (or arm) contact with 

ready-to-eat foods or if the food employee contacts exposed RTE food with bare hands at the time the 

RTE food is being added as an ingredient to a food that: 

• Contains a raw animal food and is to be cooked in the food establishment to heat all parts of the 

food to minimum temperatures specified in ¶¶3-401.11(A)-(B) or §3-401.12; or 

• Does not contain a raw animal food but is to be cooked in the food establishment to heat all parts 

of the food to a temperature of at least 63°C (145°F). 

This item is also marked IN compliance when food employees are observed properly following a preapproved alternative procedure to no bare hand contact. 

This item should be marked OUT of compliance if one food employee is observed ready-to-eat food with 

their bare hands in the absence of a prior approval and written procedures for bare hand contact. Refer 

to subparagraph 3-301.11 (E)(1)-(7) for a listing of conditions that must be met in order to receive prior 

approval by the Regulatory Authority. Bare hand contact by food employees serving a Highly Susceptible 

Population is prohibited and no alternative to bare hand contact is allowed. This item is also marked OUT 

when food employees contact exposed RTE food with bare hands that is to be added as ingredients to a 

food that is not properly heat treated as specified in Sub-¶3-301.11(D)(1)-(2). 

N.A. This item may be marked N.A. for establishments that provide only packaged, or bulk food items that are 

not ready-to-eat.

N.O. This item may be marked N.O. for establishments that prepare ready-to-eat foods only, but no food 

preparation is performed at the time of inspection.

Applicable Code Sections: 

3-301.11 Preventing Contamination from Hands (P, Pf, C)

3-801.11(D) Pasteurized Foods, Prohibited Re-Service, and Prohibited Foods (P)

10. Adequate handwashing sinks, properly supplied and accessible

IN/OUT This item must be marked IN or OUT of compliance based on observations in determining that 

handwashing sinks are properly equipped and conveniently located for employee use in food 

preparation, food dispensing and warewashing areas as well as in or immediately adjacent to 

toilet rooms. This item must be marked OUT of compliance when the facility is not stocked 

with soap, hand drying provisions or equipped with the required signage. In addition, if the 

handwashing sink is not located to be available to employees who are working in a food 

preparation area, food dispensing and warewashing areas and is blocked by portable 

equipment or stacked full of soiled utensils or other items, or the facility is unavailable for 

regular employee use, this item must be marked OUT of compliance.
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N.A. Do Not Mark this item N.A.

N.O. Do Not Mark this item N.O.

Applicable Code Sections: 

5-202.12 Handwashing Sinks, Installation ((Pf, C) 

5-203.11 Handwashing Sinks-Numbers and Capacities (Pf)

5-204.11 Handwashing Sinks-Location and Placement (Pf)

5-205.11 Using a Handwashing Sink-Operation and Maintenance (Pf)

6-301.11 Handwashing Cleanser, Availability (Pf)

6-301.12 Hand Drying Provision (Pf)

6-301.13 Handwashing Aids and Devices, Use Restrictions (C)

6-301.14 Handwashing Signage (C)

Food From a Source That Complies with Law

11. Food obtained from sources that comply with Law 

IN/OUT This item should be marked IN or OUT of compliance based on direct observations of food 

products, food labels and packaging, water analyses, and discussion with the PIC or other 

food employees. This item should be marked IN compliance when the regulatory authority is 

able to determine food has been received from sources that comply with LAW. . A review of 

supplier names, shipment invoices, buyer specification plans, molluscan shellfish tags, proof

of regulatory permit/licensure of a food source, etc. can be used to document approved food 

sources. Wild harvested mushrooms if sold or served have been approved by the regulatory 

authority. Milk and milk products must comply with Grade A Standards. This item should be 

marked OUT of compliance when it cannot be determined that food is received from a source 

that complies with LAW and if the regulatory authority did not approve the sale or service of 

wild harvested mushrooms and it is observed in the food establishment for sale and service.

N.A. Do Not Mark this item N.A.

N.O. Do Not Mark this item N.O.

Applicable Code Sections:

3-201.11 Compliance with Food Law (P, Pf, C)

3-201.12 Food in a Hermetically Sealed Container (P)

3-201.13 Fluid Milk and Milk Products (P)

3-201.14 Fish (P)

3-201.15 Molluscan Shellfish (P)

3-201.16 Wild Mushrooms (P)

3-201.17 Game Animals (P, C)

3-202.13 Eggs (P)

3-202.14 Eggs and Milk Products, Pasteurized (P)
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3-202.110 Juice Treated-Commercially Processed (P, Pf)

5-101.13 Bottled Drinking Water (P)

12. Food received at proper temperature 

IN/OUT This item should be marked IN or OUT of compliance based on actual food temperature 

measurements of TCS foods being received. This item should be marked IN compliance when 

food is received and found at proper temperatures during the inspection (i.e. catered meal for 

child care center arrives during the inspection and the regulatory authority verifies receiving 

temperature). This item should be marked OUT of compliance if food is received and 

accepted, but an actual food temperature measurement of a TCS food by the regulatory 

authority at the time of delivery exceeds the temperature specifications for receiving as 

prescribed by the Code.

N.A. This item may be marked N.A. for retail operations when the establishment receives only 

foods that are not TCS food and that are not frozen.

N.O. This item may be marked N.O. if food is not received during the inspection.

Applicable Code Sections:

3-202.11 Temperature (P, Pf)

13. Food in good condition, safe and unadulterated

IN/OUT This item must be marked IN or OUT of compliance based on direct observations of the 

integrity of product packaging, wholesomeness, and signs of adulteration. This item must be 

marked IN compliance when a dent in a canned food has not compromised the hermetic seal; 

cuts made in outer cardboard packaging during opening of the case do not enter the inner 

product packaging; the true appearance, color, or quality of a food is not misrepresented; and 

food is honestly presented. This item must be marked OUT of compliance when the integrity of 

food packaging has been compromised or the true appearance, color, or quality of a food has 

been intentionally altered.

N.A. Do Not Mark this item N.A.

N.O. Do Not Mark this item N.O. 

Applicable Code Sections:

3-101.11 Safe, Unadulterated and Honestly Presented (P)

3-202.15 Package Integrity (Pf)

14. Required records available: molluscan shellfish identification, parasite destruction

IN/OUT This item should be marked IN or OUT of compliance based on direct observations of fish in 

storage, molluscan shellfish identification, and/or records of freezing of fish for parasite 

destruction. This item should be marked IN compliance if the permit holder provides a 

statement from supplier(s) identifying that fish sold as raw, raw-marinated or undercooked is 

frozen by supplier for parasite destruction; or there are freeze records maintained by the 

permit holder when fish are frozen for parasite destruction on the premises. This item should 

be marked OUT of compliance if there are no molluscan shellfish identification, when the 

molluscan shellfish identification are incomplete, when there is evidence of commingling, or 
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Annex 7 -32

when no records of freezing of fish for parasite destruction are available. Fish exempt from 

freezing requirements are found in paragraph 3-402.11(B).

N.A. This item may be marked N.A. when molluscan shellifsh are not used in the establishment and 

the only fish sold as raw, raw-marinated or undercooked is the tuna species or aquacultured 

fish listed as exempted from freezing in the Food Code. 

N.O. This item may be marked N.O. when molluscan shellfish or raw, raw-marinated and 

undercooked fish are sold periodically in the establishment, but are not being sold at the time 

of inspection and prior compliance through tags, invoices, or purchase records cannot be 

verified.

Applicable Code Sections:

3-202.18 Molluscan Shellfish, Packaging and Identification (Pf, C)

3-203.12 Molluscan Shellfish, Maintaining Identification (Pf)

3-402.11 Parasite Destruction (P, C)

3-402.12 Records, Creation, & Retention (Pf)

Protection from Contamination

15. Food separated and protected

IN/OUT This item should be marked IN or OUT of compliance based on direct observations of food 

storage and food handling practices. This item should be marked OUT of compliance when 

ready-to-eat foods are subject to potential contamination by raw animal foods; raw animal 

foods are observed not separated by type based on minimum cook temperatures by 

spacing or placing in separate containers; unpackaged comminuted or otherwise non intact 

meats are stored above unpackaged whole muscle intact cuts of meat; food is not packaged 

or covered during storage (unless in the process of cooling); or food is in contact with soiled 

equipment and utensils; or single-use gloves used for more than one task. An exception is 

included that allows the following: storage and display of frozen, commercially packaged 

raw animal food adjacent to or above frozen, commercially packaged ready-to-eat food and 

combining raw animal foods with ready-to-eat foods when combined as ingredients for 

future preparation or cooking.

N.A. This item may be marked N.A. when there are no raw animal foods used in the facility and 

only prepackaged foods are sold.

N.O. This item is marked N.O. when raw animal foods are used or served seasonally and you are 

unable to determine compliance.

Applicable Code Sections:

3-302.11 Packaged and Unpackaged Food-Separation, Packaging, and Segregation (P, C)

3-304.11 Food Contact with Equipment, Utensils, and Linens (P)

3-304.15(A)Gloves, Use Limitation (P)

3-306.13(A)Consumer Self-Service Operations (P)

16. Food-contact surfaces: cleaned and sanitized

IN/OUT This item must be marked IN or OUT of compliance based on direct observations of foodcontact surfaces of equipment and utensils; actual measurements/readings of chemical 
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sanitizer concentration, hot water sanitizing temperature, pH, hardness, water pressure, etc. 

using test strips, heat-sensitive tapes, and equipment gauges; observations of cleaning and 

sanitizing procedures; and discussion of cleaning and sanitizing procedures and frequency 

with the PIC or other food employees. This item must be marked IN compliance when manual 

and/or mechanical methods of cleaning and sanitizing are effective, and performed at the 

prescribed frequency. There should be an overall assessment of the food-contact surfaces of 

equipment and utensils in clean storage and in use to determine compliance. For example, 

this item is not marked OUT of compliance based on one visibly soiled utensil, such as a plate 

or knife. This item must be marked OUT of compliance when manual and/or mechanical 

methods of cleaning and sanitizing food-contact surfaces of equipment and utensils are 

ineffective, or if one multiuse piece of equipment such as a slicer or can opener is visibly 

soiled and being used at the time of the inspection. This item is also marked OUT if it is 

observed that equipment or utensils that have come into contact with a major food allergen 

such as fish was not cleaned and sanitized prior to use for other types of raw animal foods.

N.A. This item may be marked N.A. only when there is no requirement to clean equipment and 

utensils such as when only prepackaged foods are sold.

N.O. Do Not Mark this item N.O.

Applicable Code Sections:

4-501.111 Manual Warewashing Equipment, Hot Water Sanitization Temperatures (P)

4-501.112 Mechanical Warewashing Equipment, Hot Water Sanitization Temperatures (Pf)

4-501.113 Mechanical Warewashing Equipment, Sanitization Pressure (C)

4-501.114 Manual and Mechanical Warewashing Equipment, Chemical Sanitization-Temperature, 

pH, Concentration and Hardness (P, Pf)

4-501.115 Manual Warewashing Equipment, Chemical Sanitization Using Detergent-Sanitizers (C)

4-601.11(A) Equipment, Food-Contact Surfaces, Nonfood-Contact Surfaces, and Utensils (Pf)

4-602.11 Equipment Food-Contact Surfaces and Utensils-Frequency (P, C)

4-602.12 Cooking and Baking Equipment (C)

4-702.11 Before Use After Cleaning (P)

4-703.11 Hot Water and Chemical-Methods (P)

17. Proper disposition of returned, previously served, reconditioned, and unsafe food

IN/OUT This item must be marked IN or OUT of compliance. This item is marked OUT of compliance if 

food is found unsafe, adulterated, not honestly presented, from an unapproved source, or if 

ready-to-eat food is contaminated by employees and is not discarded or reconditioned 

according to an approved procedure, or if previously served unwrapped, unprotected food is 

observed being re-served.

N.A. Do Not Mark this item N.A.

N.O. Do Not Mark this item N.O.

Applicable Code Sections:

3-306.14 Returned Food and Re-service of Food (P)
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3-701.11 Discarding or Reconditioning Unsafe, Adulterated, or Contaminated Food (P)

Time Temperature Control for Safety Food (TCS Food)

18. Proper cooking time and temperatures

NOTE: The cooking temperatures of foods must be measured to determine compliance or 

noncompliance. Do not rely upon discussions with managers or cooks to make a 

determination of compliance or noncompliance. The temperature of raw animal foods in each 

species cooked during the inspection should be taken. For instance, if the facility fries chicken, 

scrambles eggs, bakes fish, grills hamburgers, and slow-roasts prime rib during the inspection 

– the cook temperatures of all of the products should be measured and recorded. 

Temperatures, both IN compliance and OUT of compliance, should be recorded in the 

“Temperature Observations” section of the inspection report. If there is insufficient space for 

the number of temperatures taken, additional temperatures should be documented in the 

“Observations and Corrective Actions” section on the second page of the inspection report. 

The time of inspections should be varied so that cooking can be observed.

IN/OUT This item should be marked IN or OUT of compliance. This item should be marked OUT of 

compliance if the items checked do not meet the temperature requirements or manufacturer’s 

instructions for cooking and the employee doing the cooking attempts to serve the product 

without returning the product to the cooking process. If a food is cooked below the required 

temperature but the facility has an approved Consumer Advisory or an approved variance with 

HACCP plan for that food item, mark the item IN compliance, record the temperature and 

document the reason it is IN compliance. Foods cooked with a non-continuous cooking 

process are marked OUT of compliance if the food item does not meet the time/temperature 

requirements for cooking as specified in 3-401.11(A)-(C) and if written procedures describing 

how the foods are prepared and stored after initial heating but prior to cooking for sale or 

service are not available for review. In situations where food bears information from the 

manufacturer indicating that the food has not been processed to control pathogens, the food 

can be cooked to a time and temperature that has been commonly applied to that type of food 

(e.g., heating spiced apple cider to boiling).

N.A. This item may be marked N.A. when no raw animal foods are cooked in the establishment.

N.O. This item may be marked N.O. when you are unable to determine the cooking temperature of 

any food. The inspection should be arranged at an optimum time for measuring at least one 

cooked item.
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Internal Cooking Temperature Specifications for Raw Animal Foods 

Internal Cooking 

Temperature Raw Animal Foods

145°F for 15 seconds

• Raw eggs cooked for immediate service

• Fish, except as listed below

• Intact Meat, except whole meat roasts* and wholemuscle intact beef steak**

• Commercially raised game animals, rabbits

155°F for 17 seconds:

• Ratites (Ostrich, Rhea and Emu)

• Non-Intact Meats

• Raw eggs not for immediate service

• Comminuted fish, or commercially raised game animals

165°F for <1 second 

(instantaneous):

• Wild game animals

• Poultry

• Stuffed fish, meat, pork, pasta, ratites & poultry

• Stuffing containing fish, meat, ratites & poultry

* Whole Meat Roasts: Refer to cooking charts in the Food Code ¶ 3-401.11(B)

** Whole-Muscle Intact Beef Steak: Refer to cooking cooking recommendations in the Food Code

 ¶ 3-401.11(C)

Applicable Code Sections:

3-401.11 Raw Animal Foods-Cooking (P, Pf)

3-401.12 Microwave Cooking (P, C)

3-401.14 Non-Continuous Cooking of Raw Animal Foods (P, Pf)

3-401.15 Manufacturer Cooking Instructions (P)

19. Proper reheating procedures for hot holding

NOTE: The reheating temperatures of foods must be taken to determine compliance or 

noncompliance. Do not rely solely upon discussions with managers or cooks to determine 

compliance or noncompliance. Temperatures IN and OUT of compliance should be recorded 

in the “Temperature Observations” section of the inspection report. If there is insufficient space 

for the number of temperatures taken, additional temperatures should be documented in the 

“Observations and Corrective Actions” section of the inspection report. 

IN/OUT This item should be marked IN or OUT of compliance based on actual temperature 

measurements of foods upon completion of the reheating process and prior to being placed in 

hot holding using a calibrated food temperature measuring device. This item should be 
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marked OUT of compliance if the items checked are not reheated to the required temperatures 

or within 2 hours prior to hot holding.

N.A. This item may be marked N.A. when foods are not held over for a second service and/or 

reheating for hot holding is not performed in the establishment. 

N.O. This item may be marked N.O. such as when foods are held over for a second service, but no 

foods are reheated during the time of inspection. 

Applicable Code Sections:

3-403.11 Reheating for Hot Holding (P)

20. Proper cooling time and temperatures

NOTE: The requirement for cooling cooked TCS food, is that the food must be cooled from 135°F to 

41°F or less in 6 hrs provided that the food is cooled from 135°F to 70°F within the first 2 

hours. For example, if a facility cools chili from 135°F to 70°F in 1.5 hours; they then have 4.5 

hours to get it from 70°F to 41°F or less. There are two critical limits that must be met with 

cooling. Discussions with the person in charge along with observations should be used to 

determine compliance. For instance, during discussion the person in charge says that a food 

product was cooled overnight in the walk-in cooler. The product is checked and the 

temperature is 50°F. Eight hours have elapsed from closing to opening. This item should be 

marked OUT because the product did not cool from 135°F to 70°F within two hours and from 

135°F to 41°F or less within a total of 6 hours. Temperatures IN compliance and OUT of 

compliance should be recorded in the “Temperature Observations” section of the inspection 

report. If there is insufficient space for the number of temperatures taken, additional 

temperatures should be documented in the “Observations and Corrective Actions” section of 

the inspection report. Because the entire cooling process is difficult to observe during an 

inspection, at the onset of the inspection a determination of whether foods are currently being 

cooled should be made. If cooling is taking place, temperatures should be taken to make a 

determination of whether proper cooling is possible with procedures being used. 

IN/OUT This item should be marked IN or OUT of compliance based on actual temperatures of TCS 

foods in the cooling process. The basis for determining IN or OUT of compliance can also be 

supported through discussion and/or record review which would provide the inspector reliable 

data of the “start time” for cooling from 135°F. See above NOTE for an example of using 

actual temperature and discussion with the PIC in determining OUT of compliance without 

actually being at the establishment during the entire cooling of TCS process, from start to 

finish.

N.A. This item may be marked N.A. when the establishment does not receive raw eggs, shellstock, 

or milk, prepares no TCS food from ambient temperature ingredients that require cooling, and 

does not cool cooked TCS food.

N.O. This item may be marked N.O. when the establishment does cool TCS food, but proper 

cooling per the prescribed temperature and time parameters cannot be determined during the 

length of the inspection.
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Applicable Code Sections:

3-501.14 Cooling (P)

21. Proper hot holding temperatures

NOTE: Temperatures IN compliance and OUT of compliance should be recorded in the “Temperature 

Observations” section of the inspection report. If there is insufficient space for the number of 

temperatures taken, additional temperatures should be documented in the “Observations and 

Corrective Action” section of the inspection report.

IN/OUT This item should be marked IN or OUT of compliance based on actual food temperature 

measurements using a calibrated food temperature measuring device. This item should be 

marked IN compliance when the regulatory authority determines that, of the TCS food 

temperature measurements taken during the inspection, no hot holding temperatures are less 

than prescribed by the Code. This item is marked OUT of compliance if one TCS food is found 

out of temperature, unless Time as a Public Health Control (TPHC) is used for that TCS food.

N.A This item may be marked N.A. when the establishment does not hot hold food.

N.O. This item may be marked N.O. when the establishment does hot hold foods, but no foods are 

being held hot during the time of inspection. Inspections should be conducted during a time 

when hot holding temperatures can be taken.

Applicable Code Sections:

3-501.16(A)(1) Time/Temperature Control for Safety Food, Hot and Cold Holding (P)

22. Proper cold holding temperatures

NOTE: Temperatures IN compliance and OUT of compliance should be recorded in the “Temperature 

Observations” section of the inspection report. If there is insufficient space for the number of 

temperatures taken, additional temperatures should be documented in the “Observations and 

Corrective Action” section of the inspection report.

IN/OUT This item should be marked IN or OUT of compliance based on actual food temperature 

measurements using a calibrated food temperature measuring device. Discussions should be 

made with the PIC to determine if a food is in the process of cooling, TPHC is used, or there is 

an approved method to render a food so that it is not TCS food. This item should be marked 

IN compliance when the regulatory authority determines that, of the temperature 

measurements taken during the inspection, no cold holding temperatures are greater than 

prescribed by the Code. This item should be marked OUT of compliance if one TCS food is 

found out of temperature, with supportive evidence, unless TPHC is used for that TCS food. 

N.A. This item may be marked N.A. when the establishment does not cold hold food.

N.O This item may be marked N.O. when the establishment does cold hold food, but no foods are 

being held cold during the time of inspection. Inspections should be conducted during a time 

when hot holding temperatures can be taken.

Applicable Code Sections:

3-501.16(A)(2) and (B) Time/Temperature Control for Safety Food, Hot and Cold Holding (P)

23. Proper date marking and disposition
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IN/OUT This item should be marked IN or OUT of compliance. This item would be IN compliance when 

there is a system in place for date marking all foods that are required to be date marked and is 

verified through observation. If date marking applies to the establishment, the PIC should be 

asked to describe the methods used to identify product shelf-life or “consume-by” dating. The 

regulatory authority must be aware of food products that are listed as exempt from date 

marking. For disposition, mark IN when foods are all within date marked time limits or food is 

observed being discarded within date marked time limits or OUT of compliance, such as when 

date marked food exceeds the time limit or date-marking is not done.

N.A. This item may be marked N.A. when there is no ready-to-eat, TCS food prepared on-premise 

and held, or commercial containers of ready-to-eat, TCS food opened and held, over 24 hours 

in the establishment.

N.O. This item may be marked N.O. when the establishment does handle foods requiring date 

marking, but there are no foods requiring date marking in the facility at the time of inspection. 

Applicable Code Sections:

3-501.17 Ready-To-Eat Time/Temperature Control for Safety Food, Date Marking (Pf)

3-501.18 Ready-To-Eat Time/Temperature Control for Safety Food, Disposition (P)

 

24. Time as a Public Health Control: procedures and records

IN/OUT This item should be marked IN or OUT of compliance based on direct observations, record 

review, a discussion with the PIC, and the review of any standard operating procedures to 

determine if the intent of the Code for use of TPHC is met. This provision only applies if it is 

the actual intention or conscious decision by the PIC to store TCS food out of temperature 

control using TPHC; otherwise, it may be a cold or hot holding issue. This item should be 

marked IN compliance if there is a written procedure at the food establishment that identifies 

the types of food products that will be held using time only, describes the procedure for how 

TPHC will be implemented, and if applicable delineates how food items, previously cooked 

and cooled before time is used, are properly cooled; and food items (marked or identified) do 

not exceed the 4-hour limit at any temperature or 6-hour limit at 70°F or less. This item should 

be marked OUT of compliance when the PIC implies the use of TPHC but does not have an 

effective mechanism for indicating the point in time when the food is removed from 

temperature control to the 4 or 6-hour discard time, or a written procedure or an effective 

mechanism for using TPHC is not present at the facility.

N.A This item may be marked when the establishment does not use time only as the public health 

control

N.O. This item may be markedN.O. when the establishment uses time only as the public health 

control, but is not using this practice at the time of inspection

Applicable Code Sections:

3-501.19 Time as a Public Health Control (P, Pf, C)

Consumer Advisory

25. Consumer advisory provided for raw or undercooked food

IN/OUT This item should be marked IN or OUT of compliance based on a thorough review with the 

PIC of the posted, written and special/daily menus, to determine if untreated shell eggs, 
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meats, fish, or poultry are used as an ingredient or ordered as a raw, raw-marinated, partially 

cooked, or undercooked food. The advisory also applies to shellstock offered for sale from a 

retail service case. This item should be marked IN compliance if the establishment provides an 

advisory that meets the intent of the Food Code for both the disclosure and reminder 

components. This item should be marked OUT of compliance when raw or undercooked foods 

are served or sold and there is no consumer advisory, the food item is not disclosed, or there 

is no reminder statement. The consumer advisory does not exempt the requirement for 

freezing for parasite control, nor should it be used for foods that have only gone through the 

initial heating and cooling stages of a non-continuous cooking process. 

N.A. This item may be marked N.A. when a food establishment does not serve a ready-to-eat food 

that necessitates an advisory, i.e., an animal food that is raw, undercooked, or not otherwise 

processed to eliminate pathogens.

N.O. Do Not Mark this item N.O.

Applicable Code Sections:

3-603.11 Consumption of Animal Foods that are Raw, Undercooked, or Not Otherwise Processed 

to Eliminate Pathogens (Pf)

Highly Susceptible Population

26 Pasteurized foods used; prohibited foods not offered

NOTE: Discussions with the PIC and employees regarding whether or not certain foods are served or 

certain practices occur in the establishment, along with observations should be used to 

determine compliance. 

IN/OUT This item should be marked IN or OUT of compliance based on direct observations and

discussions with the PIC and food employees regarding whether or not certain foods are 

served or certain practices occur in an establishment serving a highly susceptible population. 

Violations of bare hand contact by food employees serving a highly susceptible population 

¶ 3-801.11(D) is marked under Item #9. This item should be marked IN compliance if only 

treated/pasteurized juices/juice beverages are served; only pasteurized eggs are used in 

recipes if eggs are undercooked and if eggs are combined, unless there is a cook step or 

HACCP plan to control Salmonella enteriditis; no raw or partially cooked animal foods or raw 

seed sprouts are served; and no unopened packaged food is re-served following service to 

patients in medical isolation or quarantine. 

N.A. This item may be markedif a highly susceptible population is not served.

N.O. Do Not Mark this item N.O.

Applicable Code Sections:

3-801.11(A), (B), (C), (E) and (G) Pasteurized Foods, Prohibited Re-Service, and Prohibited 

Food (P, C)

Food/Color Additives and Toxic Substances

27. Food additives: approved and properly used

IN/OUT This item should be marked IN or OUT of compliance based on direct observations of food 

ingredients in storage and listed as product ingredients supplemented by discussion with the 

PIC. This item is marked IN compliance if approved food and color additives are on site and 
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used properly or if sulfites are on the premises, and they are not applied to fresh 

fruits/vegetables for raw consumption. Approved food additives are listed and have threshold 

limits in accordance with the CFRs, and does not apply to food additives that are considered 

Generally Recognized as Safe (GRAS), such as salt, pepper, etc. This item is marked OUT of 

compliance if unapproved additives are found on the premises or approved additives are 

improperly used, such as sulfites being applied to fresh fruits or vegetables.

N.A. This item may be marked N.A. if the food establishment does not use any additives or sulfites 

on the premises.

N.O. Do Not Mark this item N.O.

Applicable Code Sections:

3-202.12 Additives (P)

3-302.14 Protection from Unapproved Additives (P)

28. Toxic substances properly identified, stored, and used; held for retail sale, properly

Stored 

IN/OUT This item should be marked IN or OUT of compliance based on direct observations of food 

labeling, storage, reconstitution, and application of bulk and working containers of cleaning 

agents and sanitizers, personal care items, first aid supplies, medicines, pesticides, and 

potential toxic and poisonous substances. This item should be marked IN compliance when 

bulk and working containers of cleaning agents and sanitizers are labeled; sanitizing solutions 

are not exceeding the maximum concentrations; personal care items, first aid supplies, 

medicines, and chemicals are stored separate from and not above food, equipment, utensils, 

linens, and single-service and single-use articles; and restricted use pesticides are applied 

only by or under the supervision of a certified applicator. This item should be marked OUT of 

compliance if a cleaning agent or sanitizer is not properly identified and stored; if a sanitizing 

solution has a higher concentration than prescribed and medicines and first aid kits are 

improperly labeled and stored. Violations of solutions exceeding the recommended 

concentration in chemical washes for fruits and vegetables (§7-204.12) would be marked 

under Item #42.

N.A. This item may be marked N.A. if the establishment does not hold poisonous or toxic materials 

for retail sale.

N.O. Do Not Mark this item N.O. 

Applicable Code Sections:

7-101.11 Identifying Information, Prominence-Original Containers (Pf)

7-102.11 Common Name-Working Containers (Pf)

7-201.11 Separation-Storage (P)

7-202.11 Restriction-Presence and Use (Pf)

7-202.12 Conditions of Use (P, Pf, C)

7-203.11 Poisonous or Toxic Material Containers-Container Prohibitions (P)

7-204.11 Sanitizers, Criteria-Chemicals (P)
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7-204.12 Chemicals for Washing, Treatment, Storage and Processing Fruits and Vegetables, 

Criteria (P,)

7-204.13 Boiler Water Additives, Criteria (P)

7-204.14 Drying Agents, Criteria (P)

7-205.11 Incidental Food Contact, Criteria-Lubricants (P)

7-206.11 Restricted Use Pesticides, Criteria (P)

7-206.12 Rodent Bait Stations (P)

7-206.13 Tracking Powders, Pest Control and Monitoring (P, C)

7-207.11 Restriction and Storage-Medicines (P, Pf)

7-207.12 Refrigerated Medicines, Storage (P)

7-208.11 Storage-First Aid Supplies (P, Pf)

7-209.11 Storage-Other Personal Care Items (C)

7-301.11 Separation-Storage and Display, Stock and Retail Sale (P)

Conformance with Approved Procedures

29. Compliance with variance, specialized process, reduced oxygen packaging criteria or HACCP 

plan

NOTE Except for fish a HACCP plan is not required when a TCS food is packaged using a reduced 

oxygen packaging method and is labeled with production time and date, held at required cold 

holding temperature, and removed from ROP packaging within 48 hours after packaging at the 

food establishment.

IN/OUT This item should be marked IN or OUT of compliance based on direct observations of food 

preparation and storage, a discussion with the PIC to determine if there are specialized food 

processes [i.e. smoking food, curing food, reduced oxygen packaging, using food additives to 

render a food so that it is not TCS food, cook chill, sous vide, etc.] and the record review of 

standard operating procedures and HACCP documentation. This item should be marked IN 

compliance when observations of food operations and review of available records indicate 

compliance is being met with regards to specialized food processes and HACCP plans were 

submitted to the regulatory authority prior to conducting a ROP operation that conforms to 

procedures within §3-502.12.This item should be marked OUT of compliance if the inspection 

reveals specialized food processes that are not approved by the regulatory authority are 

performed or not conducted in accordance with the approved variance or a HACCP plan was 

not submitted to the regulatory authority prior to engaging in a ROP operation without a 

variance or the approved variance is not retained in the food establishment.

N.A. This item may be marked N.A. if the establishment is not required by the regulatory authority 

to have a variance or HACCP plan, juice is not packaged or reduced oxygen packaging is not 

done on the premises.

N.O. Do Not Mark this item N.O.

Applicable Code Sections:

3-404.11 Treating Juice (P, Pf)

3-502.11 Variance Requirement (Pf)

3-502.12 Reduced Oxygen Packaging, Criteria (P, Pf)
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4-204.110(B) Molluscan Shellfish Tanks (Pf)

8-103.12 Conformance with Approved Procedures (P, Pf)

8-201.13 When a HACCP Plan is Required (C)

8-201.14 Contents of a HACCP Plan (Pf)

Good Retail Practices (GRPs)

D. Marking Instructions for each GOOD RETAIL PRACTICE (GRP) ON the 

Inspection Report 

Good Retail Practices (GRPs) are systems to control basic operational and sanitation conditions within a 

facility, and if not controlled, they could be contributing factors to foodborne illness by introducing hazards 

(biological, chemical and physical), into the end product, either directly or indirectly. For example, 

equipment in disrepair, such as a cutting board with deep grooves/cuts, makes effective cleaning difficult 

or impossible, and thereby could introduce a bacterial hazard onto food that comes into contact with the 

board. In addition, in assessing GRPs, it is important to make an overall assessment of the conditions by 

looking for trends versus an isolated incident; and the potential public health impact. For example, a few 

missing floor tiles in a dry area may not rise to the level of a “violation”; however, missing floor tiles in an 

area where equipment is subject to in-place manual cleaning without the use of an enclosed clean in 

place (CIP) system, i.e., using pressure hoses over band saws, slicers, or mixers, could create conditions 

whereby a bacterial hazard could be introduced on to the food equipment. These items usually require 

judgment, and if uncorrected, the regulatory authority must decide whether or not these conditions would 

lead to potential contamination. 

GRPs are the methods used in, or the facilities or controls used for, the receiving, preparation, storage, 

serving, packaging or holding of food which are designed to assure unsanitary conditions do not lead to 

the introduction of hazards or unintentional substances into the end product. The intention of this 

inspection form is to focus the inspector’s attention on those factors that have been shown to be most 

often linked with causing foodborne illness. Since the major emphasis of an inspection should be on the 

Risk Factors that cause foodborne illness and the Public Health interventions that have the greatest 

impact on preventing foodborne illness, the GRPs have been given less importance on the inspection 

form and a differentiation between IN, OUT, N.A. and N.O. is not made in this area, with a few exceptions 

noted below. For marking the GRPs section, place an “X” in the box to the left of the numbered item if a 

code provision under that item is of compliance. Document each violation of the code provision for the 

item number in the “Observations and Corrective Actions” section on the second page of the inspection 

report. For items marked OUT of compliance, further indicate the VIOLATION STATUS by marking an 

“X” in the corresponding box: COS = Corrected on site during inspection and R = Repeat violation per 

the same instructions as given in the Risk Factor section. References to the appropriate Food Code 

provisions that can be debited under each numbered GRP item are listed in Guide 3-B. 

Note: Items 30, 32, and 33 will allow for either three or four marking options. Item 30 allows for IN OUT or 

N.A., and items 32 and 33 allow for IN, OUT, N.A .or N.O. For marking in the GRP Section place an “A” in 

the box to the left of the numbered item if the code provision under that item is not applicable or and “O” 

for not observed. 

E. TEMPERATURE OBSERVATIONS

Item/location 

Record the common name of the food as well as the condition, process, and location of 

the food at the time of monitoring e.g. hot holding, refrigerator, prep-table. Temperatures 

in compliance and out of compliance should be documented. If there is insufficient space 
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for the number of temperatures taken, record the additional temperatures in the 

“Observations and Corrective Actions” section of the inspection report.

Food Temperature

Record the temperature indicated on the inspector’s thermometer. Specify the 

measurement in °F or °C. (Note: Food temperature measuring devices that are scaled 

only in Fahrenheit should be accurate to ±2°F in the intended range of use. Food 

temperature measuring devices that are scaled only in Celsius or dually scaled in Celsius 

and Fahrenheit should be accurate to ± 1°C in the intended range of use.)

F. OBSERVATIONS AND CORRECTIVE ACTIONS

Include here specific descriptions of violations observed and recorded in the Risk Factors and 

Interventions section and Good Retail Practices check boxes. Also include corrective actions for the 

noted violations and temperatures if there is insufficient space in the allotted section for temperature 

recordings. 

G. SIGNATURE BLOCK

Field Description

Person in Charge The PIC is the individual present at a food establishment who is responsible 

for the operation at the time of the inspection.

Inspector The Inspector is the individual conducting the inspection.

Date The date the inspection is completed.

Follow-up The determination of whether to conduct a reinspection or other enforcement 

action.

Follow-up Date The date the follow-up inspection will be conducted

Safe Food and Water

30. Pasteurized eggs used where required

Certain menu items use eggs as an ingredient in the preparation of RTE foods, such as Caesar salad, 

Hollandaise sauce, etc. This is verified by discussion with the PIC and food employees regarding the 

substitution of pasteurized egg products for raw eggs in uncooked foods, unless allowed under 

¶ 3-401.11(D)(2).
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Applicable Code Section:

3-302.13 Pasteurized Eggs Substituted for Raw Eggs for Certain Recipes (P)

31. Water and ice from approved source

There are two types of systems: Public Water System or Non-Public Water System. Regardless of its 

source, it must meet drinking water standards established by EPA and applicable state drinking water 

quality standards. If a non-public system is used as Drinking water, the water is sampled / tested at least 

yearly and records retained on file at the food establishment or per state regulations. Consideration must 

be given to the supply containers, piping, hoses, etc., connected to the APPROVED source when water is 

made available for mobile and/or temporary food establishment without a permanent supply.

Applicable Code Sections:

3-202.16 Ice (P)

5-101.11 Approved System-Source (P)

5-102.11 Standards-Quality (P)

5-102.12 Nondrinking Water (P)

5-102.13 Sampling (Pf)

5-102.14 Sample Report (C)

5-104.12 Alternative Water Supply (Pf)

32. Variance obtained for specialized processing methods

When a Food Establishment wants to deviate from a requirement in the code, utilizes Specialized 

Processing Methods as specified in § 3-502.11 such as Smoking Food for Preservation, curing food etc. a 

variance must first be obtained from the regulatory authority. A HACCP plan may also be required as 

listed in ¶ 8-201.13(A) as part of the variance request. 

N.A. This item may be marked N.A. if the establishment is not engaged in a specialized processing 

method, other operation requiring a variance and a HACCP plan or a process or processing 

method determined by the regulatory authority to require a variance and a HACCP plan.

Applicable Code Section:

8-103.11 Documentation of Proposed Variance and Justification (Pf)

Food Temperature Control

33. Proper cooling methods used; adequate equipment for temperature control

A determination must first be made that cooling food is part of the processing step. To assess whether or 

not the methods used facilitate the cooling criteria specified under § 3-501.14, a discussion with the PIC 

should support actual observations used in cooling foods. There should be enough equipment with 

sufficient capacity used for the cooling, heating and hot/cold holding of foods requiring temperature 

control as specified in Chapter 3 to meet the demands of the operation. Observations must support the 

determination of compliance status. Frozen food is solid to the touch.
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Applicable Code Sections:

3-501.11 Frozen Food (C)

3-501.15 Cooling Methods (Pf, C)

4-301.11 Cooling, Heating, and Holding Capacities-Equipment (Pf)

34. Plant food properly cooked for hot holding

In determining compliance, observation along with an actual cooking temperature must be obtained.

N.A. This item may be marked N.A. if vegetables and fruits are not cooked for hot holding in the 

establishment.

N.O. This item may be marked N.O. when plant foods are cooked for hot holding, but are not 

available for observation during the inspection.

Applicable Code Section:

3-401.13 Plant Food Cooking for Hot Holding (Pf)

35. Approved thawing methods used

Observing and then gaining an understanding of the establishment’s thawing method(s) will help in 

determining whether a violation exists from the approved thawing methods found under § 3-501.13 as 

well as the level of risk imposed. Keep in mind that various food products especially those destined for 

deep-fat frying are often slacked (not thawed) prior to cooking.

Applicable Code Sections:

3-501.12 Time/Temperature Control for Safety Food, Slacking (C)

3-501.13 Thawing (Pf)

N.A. This item may be marked N.A. if TCS food are not thawed.

N.O. This item may be marked N.O. if this food is thawed, but thawing was not observed during the 

inspection.

36. Thermometers provided and accurate

Thermometers provide a means for assessing active managerial control of TCS food temperatures. 

Determine compliance by observing the in-use storage location and verifying the scaling of 

the temperature measuring devices in the range of use to measure food, water, or ambient air 

temperatures. Food thermometers must be calibrated at a frequency to ensure accuracy. Food 

thermometers should be accessible for use by employees and have a probe size appropriate to 

the food item.

Applicable Code Sections:
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4-203.11 Temperature Measuring Devices, Food-Accuracy (Pf)

4-203.12 Temperature Measuring Devices, Ambient Air and Water-Accuracy (Pf)

4-204-112 Temperature Measuring Devices-Functionality (Pf, C)

4-302.12 Food Temperature Measuring Devices (Pf)

4-502.11(B) Good Repair and Calibration (Pf)

Food Identification

37. Food properly labeled; original container

Packaged foods are required to conform to specific labeling laws. Foods packaged within the food 

establishment must also conform to the appropriate labeling laws, be accurate and not misleading. All 

major food allergens, if present, must be accurately declared on the package. In addition, all unpackaged 

food items containing a major food allergen as an ingredient must have a written notification declaring 

which major food allergens are contained in that food item. Working containers removed from their 

original packaging require some level of assessment as to how recognizable the food is without labeling 

by its common name. Bulk foods that are available for consumer self-dispensing will need to be 

prominently labeled with the name of the food source for each major food allergen contained in the food, 

unless the food source is already part of the common name or usual name of the ingredient. Molluscan 

shellfish and vended TCS foods must specifically be assessed based on their specific packaging and 

labeling requirements. Molluscan Shellfish shall not be commingled.

Applicable Code Sections:

3-203.11 Molluscan Shellfish, Original Container (C)

3-302.12 Food Storage Containers Identified with Common Name of Food (C)

3-305.13 Vended Time/Temperature Control for Safety Food, Original Container (C)

3-601.11 Standards of Identity (C)

3-601.12 Honestly Presented (C)

3-602.11 Food Labels (Pf, C)

3-602.12 Other Forms of Information (C)

Prevention of Food Contamination

38. Insects, rodents and animals not Present

An assessment is made through observation and discussion with the PIC for measures taken to control 

the presence of pests in the food establishment, including elimination of entry points and harborage 

areas, and removal of pests and its evidence. Insect trapping devices must not be located over food 

preparation areas.

Applicable Code Sections:

2-403.11 Handling Prohibition-Animals (Pf)

6-202.13 Insect Control Devices, Design and Installation (C)

6-202.15 Outer Openings, Protected (C)

6-202.16 Exterior Walls and Roofs, Protective Barrier (C)

6-501.111 Controlling Pests (Pf, C)
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6-501.112 Removing Dead or Trapped Birds, Insects, Rodents and other Pest (C)

6-501.115 Prohibiting Animals (Pf)

39. Contamination prevented during food preparation, storage and display

The observation and understanding of the flow of food items from the point of receipt to the point of sale, 

service or distribution is necessary to determine whether a violation exists. Food is subject to direct and 

indirect sources of contamination in the establishment. Sources may be related to the working 

environment, packaging, adequacy of storage facilities, and exposure of food on display to contamination 

(i.e. salad bars).

Applicable Code Sections:

3-202.17 Shellstock, Condition (C)

3-303.11 Ice Used as Exterior Coolant, Prohibited as Ingredient (P)

3-303.12 Storage or Display of Food in Contact with Water or Ice (C)

3-304.13 Linens and Napkins, Use Limitations (C)

3-305.11 Food Storage-Preventing Contamination from the Premises (C)

3-305.12 Food Storage, Prohibited Areas (C), (Pf)

3-305.14 Food Preparation (C)

3-306.11 Food Display-Preventing Contamination by Consumers (P)

3-306.12 Condiments, Protection (C)

3-306.13(B) and (C) Consumer Self-Service Operations (Pf)

3-307.11 Miscellaneous Sources of Contamination (C)

6-404.11 Segregation and Location-Distressed Merchandise (Pf)

40. Personal cleanliness

Observation of facility personnel for clean outer clothing, effective hair restraints, prohibited jewelry and 

the condition or protection of fingernails must be made. This includes the use of single-use gloves over an 

impermeable bandage, finger cot or finger stall.

Applicable Code Sections:

2-302.11 Maintenance-Fingernails (Pf)

2-303.11 Prohibition-Jewelry (C)

2-304.11 Clean Condition-Outer Clothing (C)

2-401.13 Use of Bandages, Finger Cots, or Finger Stalls(C)

2-402.11 Effectiveness-Hair Restraints (C)

41. Wiping cloths; properly used and stored

Wiping cloths are to be used for a designated purpose and properly used. When stored in solution, the 

solutions should be reasonably clean and maintained at the proper sanitizer concentration (§4-501.114). 

Solutions exceeding the recommended sanitizer concentrations would be marked on the Inspection Form 
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under item #28, Toxic substances properly identified, stored, and used. Sponges, if present, are not to be 

used in contact with clean/sanitized food contact surfaces.

Applicable Code Sections:

3-304.14 Wiping Cloths, Use Limitation (C)

4-101.16 Sponges Use Limitation (C)

4-901.12 Wiping Cloths, Air Drying Location (C)

42. Washing fruits and vegetables

Raw fruits and vegetables are to be washed prior to their preparation or offered as RTE. Chemicals are 

allowed for washing fruits and vegetables, along with simply washing them in water. Chemicals that are 

used in the wash water for fruits and vegetables must be listed and approved with threshold limits in 

accordance with the CFR’s. Refer to the label or labeling of the additive for adequate directions and to 

assure safe use. Discussion with the PIC and food employees will help determine the establishment’s 

practice.

Applicable Code Sections:

3-302.15 Washing Fruits and Vegetables (Pf, C)

7-204.12 Chemicals for Washing, Treatment, Storage and Processing Fruits and Vegetables, 

Criteria (P )

43. In-use utensils; properly stored

Based on the type of operation, there are a number of methods available for storage of in-use utensils 

during pauses in food preparation or dispensing, such as in the food, clean and protected, or under 

running water to prevent bacterial growth. If stored in a container of water, the water temperature must be 

at least 135°F. In-use utensils may not be stored in chemical sanitizer or ice between uses. Ice scoops 

may be stored handles up in an ice bin except for an ice machine.

Applicable Code Sections:

3-304.12 In-Use Utensils, Between-Use Storage (C)

44. Utensils, equipment and linens; properly stored, dried, handled

An assessment is made of the overall storage practices and handling of clean equipment and utensils, 

including tableware located in the various areas within an establishment, including the basement, wait 

station and dining room. Equipment must be air dried prior to storage, and linens must be properly 

cleaned and stored.

Applicable Code Sections:

4-801.11 Clean Linens (C)

4-802.11 Specifications-Laundering Frequency (C)

4-803.11 Storage of Soiled Linens (C)

4-803.12 Mechanical Washing (C)

4-901.11 Equipment and Utensils, Air-Drying Required (C)
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4-903.11(A), (B) and (D) Equipment, Utensils, Linens and Single-Service and Single-Use ArticlesStoring(C)

4-903.12 Prohibitions (C), (Pf)

4-904.11 Kitchenware and Tableware-Preventing Contamination (C)

4-904.12 Soiled and Clean Tableware (C)

4-904.13 Preset Tableware (C)

4-904.14 Rinsing Equipment and Utensils after Cleaning and Sanitizing(C)

45. Single-use/single-service articles; properly stored, used

These items are not designed to be cleaned and re-used; therefore, they must be properly stored and 

protected to prevent from possible contamination. Food establishments without facilities for cleaning and 

sanitizing kitchenware and tableware shall provide only single-use and single-service articles.

Applicable Code Sections:

4-502.12 Single-Service and Single-Use Articles, Required Use (P)

4-502.13 Single-Service and Single-Use Articles-Use Limitations (C)

4-502.14 Shells, Use Limitations (C)

4-903.11(A) and (C) Equipment, Utensils, Linens and Single-Service and Single-Use ArticlesStoring(C)

4-903.12 Prohibitions (C)

4-904.11 Kitchenware and Tableware-Preventing Contamination (C)

46. Gloves used properly

The observation of food preparation activities and glove-use by food employees is necessary. There 

should be a discussion with the PIC on how gloves are used, if applicable, in food preparation activities. 

Gloves may serve as a source of cross-contamination if misused.

Applicable Code Sections:

3-304.15(B)-(D) Gloves, Use Limitations (C)

Utensils, Equipment and Vending

47. Food and non-food-contact surfaces cleanable, properly designed, constructed and used

Equipment and utensils must be properly designed and constructed, and in good repair. Proper 

installation and location of equipment in the food establishment are important factors to consider for ease 

of cleaning in preventing accumulation of debris and attractants for insects and rodents. The components 

in a vending machine must be properly designed to facilitate cleaning and protect food products (e.g., 

equipped with automatic shutoff, etc.) from potential contamination. Equipment must be properly used 

and in proper adjustment, such as calibrated food thermometers. 

Applicable Code Sections:
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3-304.16 Using Clean Tableware for Second Portions and Refills (C)

3-304.17 Refilling Returnables (P)

4-101.11 Characteristics-Materials for Construction and Repair (P, C)

4-101.12 Cast Iron, Use Limitations (C)

4-101.13 Lead, Use Limitation (P, C)

4-101.14 Copper Use Limitation (P)

4-101.15 Galvanized Metal, Use Limitation (P)

4-101.17 Wood, Use Limitation (C)

4-101.18 Nonstick Coatings, Use Limitation (C)

4-101.19 Nonfood-Contact Surfaces (C)

4-102.11 Characteristics-Single-Service and Single-Use (P, C)

4-201.11 Equipment and Utensils-Durability and Strength (C)

4-201.12 Food Temperature Measuring Devices (P)

4-202.11 Food-Contact Surfaces-Cleanability (Pf)

4-202.12 CIP Equipment (Pf, C)

4-202.13 V” Threads, Use Limitation (C)

4-202.14 Hot Oil Filtering Equipment (C)

4-202.15 Can Openers (C)

4-202.16 Nonfood-Contact Surfaces (C)

4-202.17 Kick Plates Removable (C)

4-204.12 Equipment Openings, Closures and Deflectors (C)

4-204.13 Dispensing Equipment, Protection of Equipment and Food (P, C)

4-204.14 Vending Machine Vending Stage Closure (C)

4-204.15 Bearings and Gear Boxes, Leakproof (C)

4-204.16 Beverage Tubing, Separation(C)

4-204.17 Ice Units, Separation of Drains (C)

4-204.18 Condenser Unit, Separation (C)

4-204.19 Can Openers on Vending Machines (C)

4-204.110(A) Molluscan Shellfish Tanks (P)

4-204.111 Vending Machines, Automatic Shutoff (P) 

4-204.120 Equipment Compartments, Drainage (C)

4-204.121 Vending Machines, Liquid Waste Products (C)

4-204.122 Case Lot Handling Apparatuses, Movability (C)

4-204.123 Vending Machine Doors and Openings (C)

4-302.11 Utensils, Consumer Self-Service (Pf)
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4-401.11 Equipment, Clothes Washers, Dryers and Storage Cabinets, Contamination PreventionLocation (C), (Pf)

4-402.11 Fixed Equipment, Spacing or Sealing-Installation (C)

4-402.12 Fixed Equipment, Elevation or Sealing (C)

4-501.11 Good Repair and Proper Adjustment-Equipment (C)

4-501.12 Cutting Surfaces (C)

4-501.13 Microwave Ovens (C)

4-502.11(A) and (C) Good Repair and Calibration-Utensils and Temperature and Pressure Measuring 

Devices (C)

4-603.11 Dry Cleaning-Methods (C)

4-902.11 Food-Contact Surfaces-Lubricating and Reassembling (C)

4-902.12 Equipment-Lubricating and Reassembling (C)

48. Warewashing Facilities, Installed, Maintained, Used, Test Strips

Adequate warewashing facilities must be available and used for the cleaning and sanitization of foodcontact surfaces, including the availability of means to monitor its use and the effectiveness of 

sanitization. For example, an irreversible registering temperature indicator is provided and readily 

accessible for measuring the utensil surface temperature for establishments that have a hot water 

mechanical warewashing operation. Observation of manual and mechanical warewashing methods are 

made to assess the procedure for cleaning and sanitizing equipment and utensils. This item is marked 

OUT of compliance when cleaners and sanitizers are not available for use within the food establishment.

Applicable Code Sections:

4-203.13 Pressure Measuring Devices, Mechanical Warewashing Equipment (C)

4-204.113 Warewashing Machine, Data Plate Operation Specifications (C)

4-204.114 Warewashing Machines, Internal Baffles (C)

4-204.115 Warewashing Machines, Temperature Measuring Devices (Pf)

4-204.116 Manual Warewashing Equipment, Heaters and Baskets (Pf)

4-204.117 Warewashing Machines, Automatic Dispensing of Detergents and Sanitizers (Pf)

4-204.118 Warewashing Machines, Flow Pressure Device (C)

4-204.119 Warewashing Sinks and Drainboards, Self-Draining (C)

4-301.12 Manual Warewashing, Sink Compartment Requirements (Pf, C)

4-301.13 Drainboards (C)

4-302.13 Temperature Measuring Devices, Manual and Mechanical Warewashing (Pf)

4-302.14 Sanitizing Solutions, Testing Devices (Pf)

4-303.11 Cleaning Agents and Sanitizers, Availability (Pf)
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4-501.14 Warewashing Equipment, Cleaning Frequency (C)

4-501.15 Warewashing Machines, Manufacturers’ Operating Instructions (C)

4-501.16 Warewashing Sinks, Use Limitation (C)

4-501.17 Warewashing Equipment, Cleaning Agents (Pf)

4-501.18 Warewashing Equipment, Clean Solutions (C)

4-501.19 Manual Warewashing Equipment, Wash Solution Temperature (Pf)

4-501.110 Mechanical Warewashing Equipment, Wash Solution Temperature (Pf)

4-501.116 Warewashing Equipment, Determining Chemical Sanitizer Concentration (Pf)

4-603.12 Precleaning (C)

4-603.13 Loading of Soiled Items, Warewashing Machines (C)

4-603.14 Wet Cleaning (C)

4-603.15 Washing, Procedures for Alternative Manual Warewashing Equipment (C)

4-603.16 Rinsing Procedures (C) 

49. Non-food-contact surfaces clean

Observations should be made to determine if the frequency of cleaning is adequate to prevent soil 

accumulations on non-food-contact surfaces.

Applicable Code Sections:

4-601.11(B) and (C) Equipment, Food-Contact Surfaces, Nonfood-Contact Surfaces, and Utensils (C)

4-602.13 Nonfood Contact Surfaces (C)

Physical Facilities

50. Hot and cold water available; adequate pressure

Regardless of the supply system, the distribution of water to the facility must be protected and operated 

according to law. Adequate pressure is to be maintained at all fixtures during peak demand including the 

capacity to provide hot water at peak hot water demand.

Applicable Code Sections:

5-103.11 Capacity-Quantity and Availability (Pf)

5-103.12 Pressure (Pf)

5-104.11 System-Distribution, Delivery, and Retention (Pf)

51. Plumbing installed; proper backflow devices

The observation of an approved plumbing system, installed and maintained, including the equipment and 

devices connected to the potable water supply, is necessary to determine whether a violation exists. An 

assessment of the layout of the establishment and the water distribution system is made to determine if 

there are any points at which the potable water supply is subject to contamination or is in disrepair.
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Applicable Code Sections:

5-101.12 System Flushing and Disinfection (P)

5-201.11 Approved-Materials (P)

5-202.11 Approved System and Cleanable Fixtures (P, C)

5-202.13 Backflow Prevention, Air Gap (P)

5-202.14 Backflow Prevention Device, Design Standard (P)

5-202.15 Conditioning Device, Design (C)

5-203.13 Service Sink (C)

5-203.14 Backflow Prevention Device, When Required (P)

5-203.15 Backflow Prevention Device. Carbonator (P)

5-204.12 Backflow Prevention Device, Location (C)

5-204.13 Conditioning Device, Location (C)

5-205.12 Prohibiting a Cross Connection (P, Pf)

5-205.13 Scheduling Inspection and Service for a Water System Device (Pf)

5-205.14 Water Reservoir of Fogging Devices, Cleaning (P)

5-205.15 System Maintained in Good Repair (P, C)

5-301.11 Approved-Materials, Mobile Water Tank and Mobile Food Establishment Water Tank (P, C)

5-302.11 Enclosed System, Sloped to Drain (C)

5-302.12 Inspection and Cleaning Port, Protected and Secured (C)

5-302.13 “V” Type Threads, Use Limitation (C)

5-302.14 Tank Vent, Protected (C)

5-302.15 Inlet and Outlet, Sloped to Drain (C)

5-302.16 Hose, Construction and Identification (P, C)

5-303.11 Filter, Compressed Air (P)

5-303.12 Protective Cover or Device (C)

5-303.13 Mobile Food Establishment Tank Inlet (C)

5-304.11 System Flushing and Sanitization-Operation and Maintenance (P)

5-304.12 Using a Pump and Hoses, Backflow Prevention (C)

5-304.13 Protecting Inlet, Outlet and Hose Fitting (C)

5-304.14 Tank, Pump and Hoses, Dedication (P)

52. Sewage and waste water properly disposed

There are two types of systems: public sewage treatment plant and an individual sewage disposal 

system. Observations of the facilities overall sewage and wastewater system is necessary to determine if 

a violation exists. Indications that a system is not functioning properly may include the presence of 

sewage back-up into the establishment or outdoors on the ground. Condensate drippage and other nonsewage wastes must be drained to a system in accordance to LAW, and backflow prevention, if required, 
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installed between the sewage system and drain of equipment holding food or utensils. Mobile wastewater 

holding tanks must also be assessed for capacity and maintenance.

Applicable Code Sections:

5-401.11 Capacity and Drainage (C)

5-402.11 Backflow Prevention (P)

5-402.12 Grease Trap (C)

5-402.13 Conveying Sewage (P)

5-402.14 Removing Mobile Food Establishment Wastes (Pf)

5-402.15 Flushing a Waste Retention Tank (C)

5-403.11 Approved Sewage Disposal System (P)

5-403.12 Other Liquid Wastes and Rainwater (C)

53. Toilet facilities: properly constructed, supplied, clean

A toilet facility should be assessed to determine if: it is not an attractant to insects; the number of fixtures 

are adequate; toilet tissue and a covered trash receptacle (ladies room only) are provided; fixtures are not 

being kept clean; and the door self-closes to prevent recontamination of hands. 

Applicable Code Sections:

5-203.12 Toilets and Urinals (C)

5-501.17 Toilet Room Receptacle, Covered (C)

6-202.14 Toilet Rooms, Enclosed (C)

6-302.11 Toilet Tissue, Availability (Pf)

6-402.11 Conveniently Located (C)

6-501.18 Cleaning of Plumbing Fixtures (C)

6-501.19 Closing Toilet Room Doors (C)

54. Garbage/refuse properly disposed; facilities maintained

The assessment of the refuse collection and disposal areas for proper receptacles and maintenance is 

necessary to determine whether a violation exists. Since refuse areas may attract and harbor insects and 

pests, as well as create a public health nuisance, particular attention must be paid to the maintenance of 

the refuse facilities and area.

Applicable Code Sections:

5-501.11 Outdoor Storage Surface (C)

5-501.12 Outdoor Enclosure (C)

5-501.13 Receptacles (C)

5-501.14 Receptacles in Vending Machines (C) 

5-501.15 Outside Receptacles (C)

5-501.16 Storage Areas, Rooms and Receptacles, Capacity and Availability (C)

5-501.18 Cleaning Implements and Supplies (C)
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5-501.19 Storage Areas, Redeeming Machines, Receptacles and Waste Handling Units, 

Location(C)

5-501.110 Storage Refuse, Recyclables and Returnables (C)

5-501.111 Area, Enclosures and Receptacles, Good Repair (C)

5-501.112 Outside Storage Prohibitions (C)

5-501.113 Covering Receptacles (C)

5-501.114 Using Drain Plugs (C)

5-501.115 Maintaining Refuse Areas and Enclosures(C)

5-501.116 Cleaning Receptacles (C)

5-502.11 Frequency-Removal (C)

5-502.12 Receptacles or Vehicles (C)

5-503.11 Community or Individual Facility (C)

6-202.110 Outdoor refuse Areas, Curbed and Graded to Drain (C)

55. Physical facilities installed, maintained, and clean

Observations are made of the overall conditions or practices related to the physical facility (e.g., materials 

used, good repair, and maintained). It is important to make an overall assessment of the physical facility 

conditions to determine the level of compliance and the potential public health impact involved if 

compliance is not met. Storage of maintenance tools, use of laundry facilities, if applicable, disposal of mop 

water and separate living/sleeping quarters are included in this section.

Applicable Code Sections:

4-301.15 Clothes Washers and Dryers (C)

4-401.11(C) Equipment, Cloths Washers and Dryers, and Storage Cabinets, Contamination

Prevention (C)

4-803.13 Use of Laundry Facilities (C)

6-101.11 Surface Characteristics-Indoor Areas (C)

6-102.11 Surface Characteristics-Outdoor Areas (C)

6-201.11 Floors, Walls and Ceilings-Cleanability (C)

6-201.12 Floors, Walls, and Ceilings, Utility Lines (C)

6-201.13 Floor and Wall Junctures, Coved, and Enclosed or Sealed (C)

6-201.14 Floor Carpeting, Restrictions and Installation (C)

6-201.15 Floor Covering, Mats and Duckboards (C)

6-201.16 Wall and Ceiling Coverings and Coatings (C)

6-201.17 Walls and Ceilings, Attachments (C)

6-201.18 Walls and Ceilings, Studs, Joists, and Rafters (C)

6-202.17 Outdoor Food Vending Areas. Overhead Protection (C)

6-202.18 Outdoor Servicing Areas, Overhead Protection (C)
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6-202.19 Outdoor Walking and Driving Surfaces, Graded to Drain (C)

6-202.111 Private Homes and Living or Sleeping Quarters, Use Prohibition (P)

6-202.112 Living or Sleeping Quarters, Separation (C)

6-501.11 Repairing-Premises, Structures, Attachments, and Fixtures-Methods (C)

6-501.12 Cleaning, Frequency and Restrictions (C)

6-501.13 Cleaning Floors, Dustless Methods (C)

6-501.15 Cleaning Maintenance Tools, Preventing Contamination (Pf)

6-501.16 Drying Mops(C)

6-501.17 Absorbent Materials on Floors, Use Limitation (C)

6-501.113 Storing Maintenance Tools (C)

6-501.114 Maintaining Premises, Unnecessary Items and Litter (C)

56. Adequate ventilation and lighting; designated areas used

Observations should be made to ensure that the ventilation is adequately preventing an accumulation of 

condensation, grease or other soil from potentially contaminating food and the surrounding environment 

and that lights are at an adequate light intensity, and personal belongings are properly stored to maintain 

clean and sanitary facility and protect food and equipment.
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Annex 7 -57

Applicable Code Sections:

4-202.18 Ventilation Hood Systems, Filters (C)

4-204.11 Ventilation Hood Systems, Drip Prevention (C)

4-301.14 Ventilation Hood Systems, Adequacy (C)

6-202.11 Light Bulbs, Protective Shielding (C)

6-202.12 Heating, Ventilation, Air Conditioning System Vents (C)

6-303.11 Intensity-Lighting (C)

6-304.11 Mechanical-Ventilation (C)

6-305.11 Designation-Dressing Areas and Lockers (C)

6-403.11 Designated Areas-Employee Accommodations for eating/drinking/smoking (C)

6-501.14 Cleaning Ventilation Systems, Nuisance and Discharge Prohibition (C)

6-501.110 Using Dressing Rooms and Lockers (C)
FDA Food Code 2022 Annex 7: Model Forms, Guides, and Other Aids

Annex 7 -58

Chart 4-A Summary Chart for Minimum Cooking Food Temperatures and Holding 

Times Required by Chapter 3

Food Minimum 

Temperature

Minimum Holding Time 

at the Specified 

Temperature

Raw Eggs prepared for immediate 

service 

Commercially Raised Game Animals 

and Exotic Species of Game Animals

Fish, Pork, and Meat Not Otherwise 

Specified in this 

Chart or in ¶ 3-401.11(B)

63oC (145oF) 15 seconds

Raw Eggs not prepared for immediate 

service

Comminuted Commercially Raised 

Game Animals and Exotic Species of 

Game Animals

Comminuted Fish and Meats

Injected Meats

Mechanically Tenderized Meats

70oC (158oF)

68oC (155oF)

66oC (150oF)

63oC (145oF)

< 1 second

17 seconds

1 minute

3 minutes

Poultry

Baluts

Stuffed Fish; Stuffed Meat;

Stuffed Pasta; 

Stuffed Poultry; Stuffed Ratites

Stuffing Containing Fish,

Meat, Poultry, or Ratites

Wild Game Animals

74oC (165oF) < 1 second, 

Instantaneous

Food Cooked in A Microwave Oven 74oC (165oF)

And hold for 2 minutes 

after removing from 

microwave oven
FDA Food Code 2022 Annex 7: Model Forms, Guides, and Other Aids

Annex 7 -59

Chart 4-B Summary Chart for Minimum Food Temperatures and Holding 

TimesRequired by Chapter 3 for Reheating Foods for Hot Holding

Food Minimum 

Temperature

Minimum Holding 

Time at the Specified 

Temperature

Maximum 

Time to 

Reach 

Minimum 

Temperature

¶ 3-403.11(A) and (D) 

Food that is cooked,

cooled, and reheated

74°C (165°F) 15 seconds 2 hours

¶ 3-403.11(B) and (D) 

Food that is reheated in 

a microwave oven

74°C (165°F)

and hold for 2 minutes

after reheating

2 hours

¶ 3-403.11(C) and (D) 

Food that is taken from a 

commercially processed, 

hermetically sealed 

container or intact 

package

57°C (135°F) No time specified 2 hours

Roasts: Option A

¶ 3-403.11(E) Unsliced 

portions of meat roasts 

cooked as specified 

under ¶ 3-401.11(B)

Same oven 

parameters and 

minimum time 

and 

temperature 

conditions as 

specified under 

¶ 3-401.11(B)

Same oven 

parameters and 

minimum time and 

temperature conditions 

as specified under 

¶ 3-401.11(B)

Not applicable

Roasts: Option B

¶ 3-403.11(E) Unsliced 

portions of meat roasts 

cooked as specified 

under ¶ 3-403.11(A)

74°C (165°F) 15 seconds 2 hours
FDA Food Code 2022 Annex 7: Model Forms, Guides, and Other Aids

Annex 7 -60

Chart 4-C Summary Chart for Ready-to-Eat, Time/Temperature Control for Safety 

Food) Date Marking § 3-501.17(A) – (E) and Disposition § 3-501.18

Example: The morning of October 1, a chicken was cooked, then cooled, refrigerated for 2 days at 41°F 

and then frozen. If the chicken is thawed October 10, the food must be consumed or discarded no later 

than midnight of October 14. 

Date Shelf Life Day Action

Oct. 1 1 Cook/cool

Oct. 2 2 Cold hold at 41°F

Oct. 3 -- Freeze

Oct. 10 3 Thaw to 41°F

Oct. 11 4 Cold hold

Oct. 12 5 Cold hold

Oct. 13 6 Cold hold

Oct. 14 7 Consume or discard
FDA Food Code 2022 Annex 7: Model Forms, Guides, and Other Aids

Annex 7 -61

Chart 4-D FDA Food Code Mobile Food Establishment Matrix

The table entitled “FDA Food Code Mobile Food Establishment Matrix” is a plan review 

and inspectional guide for mobile food establishments based on the mobile unit's menu 

and operation. Mobile units range in type from push carts to food preparation catering 

vehicles. 

To use the table, read down the columns based on the menu and operation in use. For 

example, if only prepackaged time/temperature control for safety food is served, then 

requirements listed in the TCS Food Menu - Prepackaged column apply. Likewise, if 

only food that is not time/temperature control for safety food is prepared on board, then 

requirements listed in the Not TCS Menu - Food Preparation column apply. Note that 

if a mobile food establishment has available for sale to the consumer both prepackaged 

time/temperature control for safety food and time/temperature control for safety food 

prepared on board, then the more stringent requirements of the TCS Menu - Food 

Preparation column apply. 

It is important to remember that mobile units may also be subject to all Food Code 

provisions that apply to food establishments. Consult the local regulatory authority for 

specific local requirements. 

The local regulatory authority's decision to require auxiliary support services such as a 

commissary or servicing area should be based on the menu, type of operation, and 

availability of on-board or on-site equipment. 

NOTE: The Food Code definition of "Food Establishment" does not include an 

establishment that offers only prepackaged foods that are not time/temperature control 

for safety foods. 
FDA Food Code 2022 Annex 7: Model Forms, Guides, and Other Aids

Annex 7 -62

Food Code

Time/Temperature 

for Safety Food 

(TCS) Menu

Time/Temperature 

for Safety Food 

(TCS) Menu

Not TCS Food 

Menu

Areas/Chapter Food Preparation Prepackaged Food Preparation

Personnel Applicable Sections 

of Parts 2-2 - 2-4

Applicable Sections 

of Parts 2-2 - 2-4

Applicable Sections 

of Parts 2-2 - 2-4

Food 3-101.11 

3-201.11-.16

3-202.16; Applicable 

Sections of Part 3-3; 

3-501.16 

3-501.18(A)

3-101.11

3-201.11-.16

3-303.12(A)

3-501.16

3-305.11; 3-305.12 

(Applicable to 

Service Area or 

Commissary)

3-101.11; 3-201.11

3-202.16; Applicable 

Sections of Part 3-3

Temperature 

Requirements

3-202.11; Applicable 

Sections of Parts 3-

4 & 3-5

3-202.11

3-501.16

NONE

Equipment 

Requirements

Applicable Sections 

of Parts 4-1 - 4-9 

and 5-5

Applicable Sections 

of Parts 4-1 - 4-2;

4-6 and 5-5

Applicable Sections 

of Parts 4-1 - 4-2;

4-5 - 4-6 and 5-5

Water & Sewage 5-104.12

5-203.11(A)

Part 5-3; 5-401.11

5-402.13-.15

5-104.12

5-203.11(A)

Part 5-3; 5-401.11

5-402.13 -.15

5-104.12

5-203.11(A)

Part 5-3; 5-401.11

5-402.13-.15

Physical Facility 6-101.11; 6-201.11

6-102.11(A) & (B)

6-202.15; 6-501.11

6-501.12; 6-501.111

6-101.11

6-102.11(A) & (B)

6-202.15

6-501.111

6-101.11; 6-201.11

6-102.11(A) & (B)

6-202.15; 6-501.11

6-501.12; 6-501.111

Toxic Materials Applicable Sections

of Chapter 7

Applicable Sections 

of Chapter 7

Applicable Sections

of Chapter 7

Servicing 6-202.18 / As 

necessary to comply 

with the Food Code

6-202.18 / As 

necessary to comply 

with the Food Code 

6-202.18 / As 

necessary to comply 

with the Food Code 

Compliance and 

Enforcement 

Applicable Sections 

of Chapter 8 and 

Annex 1

Applicable Sections 

of Chapter 8 and 

Annex 1

Applicable Sections 

of Chapter 8 and 

Annex 1
FDA Food Code 2022 Annex 7: Model Forms, Guides, and Other Aids

Annex 7 -63

Summary of Changes

In the 2022 FDA Food Code

This Summary provides a synopsis of the textual changes from the 2017 FDA Food 

Code and the Supplement to the 2017 Food Code Chapters and Annexes to the 2022 

edition. The primary intent of this record is to capture the nature of the changes rather 

than to identify every word or editing change. This record should not be relied upon 

as an absolute comparison that identifies each and every change.

General 

Numerous editing changes were made throughout the document for internal 

consistency, to correct some errors in the 2017 Code and for clarification. 

Updated the web links throughout the Code and Annexes.

Converted several Tables, charts, and images throughout the Code to meet web 

accessibility requirements under Section 508 of the Rehabilitation Act of 1973 (29 

U.S.C. 794d). Section 508 mandates that all federal agencies eliminate the barriers in 

accessing electronic and information technology.

Preface

Amended the Preface to revise Preface sections 3, 5, 6, and 9 to update internal 

references and to add an explanation of the change in Food Code release frequency 

from 2021 to 2022. 

Chapter 1. Purpose and Definitions

• Amended § 1-201.10 (B) to revise the definition of the term “Certification 

Number” to include all the certification and permit codes that may be found

on a shellfish tag or label.

• Amended § 1-201.10 (B) to revise the definition of the term “Commingle” to

align with the NSSP Model Ordinance.

• Amended § 1-201.10 (B) to add new term “In-Shell Product” meaning nonliving, processed shellfish with one or both shells present.

• Amended § 1-201.10 (B) to revise the definition of the term “Intact Meat” to

clarify that beef products that are vacuum tumbled with solutions are not 

considered intact meats.

• Amend §1-201.10 (B) to revise the definition of the term “Intact Meat” to add 

‘cubing or pounding’. Note: The parenthesis (including injection) was

removed in the Supplement to the 2017 Food Code due to the revised
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Annex 7 -64

definition of the term ”Mechanically Tenderized” that includes injection.

• Amended §1-201.10 (B) to revise the definition of the term “Major food

allergen” in subparagraph (1)(a) to add Sesame as the 9th major food 

allergen, effective January 1, 2023.

• Amended § 1-201.10 (B) to revise the definition of the term “Mechanically 

Tenderized” to be consistent with the USDA FSIS description of 

“Mechanically Tenderized” in the 2015 final rule titled Descriptive 

Designation of Needle- or Blade-Tenderized (Mechanically Tenderized) Beef

Product (80 FR 28153). The rule established labeling requirements for raw 

or partially cooked mechanically tenderized beef products and clarified that

products injected with a marinade or solution are considered mechanically 

tenderized.

• Amended § 1-201.10 (B) to revise the definition of the term “Molluscan

Shellfish” to clarify that the term is inclusive of shellstock, in-shell product, 

and shucked shellfish.

• Amended § 1-201-10 (B) to revise the definition of the term “Poisonous or

toxic material” to include a new fifth category “Restricted Use Pesticide”.

• Amended § 1-201.10 (B) to revise the definition of the term “Ready-to-Eat” to 

replace “Fruits and vegetables” with “Plant foods” in paragraph (2)(c).

• Amended § 1-201.10 (B) to revise the definition of the term “Ready-to-Eat

Food” to indicate what Ready-to-eat Food does not include.

• Amended § 1-201.10 (B) to revise the definition of the term “Reduced

oxygen- packaging” in subparagraph 2(d) specific to cook chill packaging, to

delete the phrase, “which have the air expelled”.

• Amended § 1-201.10 (B) to revise the definition of the term “Shellstock” to

clarify that it is live molluscan shellfish in the shell.

• Amended § 1-201.10 (B) to revise the definition of the term “Shucked

Shellfish” to clarify that both shells of this product are removed.

• Amended § 1-201.10 (B) to add a new term “Tobacco Product”.

Chapter 2. Management and Personnel

2-101.11

Amended § 2-101.11 to add new ¶(C) to address situations where the regulatory 

authority has deemed a food establishment to pose minimal risk of causing, or 

contributing to, foodborne illness based on the nature of their operation and extent of 

food preparation. 
FDA Food Code 2022 Annex 7: Model Forms, Guides, and Other Aids

Annex 7 -65

2-102.20

Amended ¶¶ 2-102.20(A) & (B) to correct the title of the Conference for Food Protection 

Standard to remove the “s” at the end of the word ‘Standards’ so it is not indicated as a 

plural word. The correct title now reads as, ‘Conference for Food Protection Standard 

for Accreditation of Food Protection Manager Certification Programs’.

2-103.11

Amended to add new paragraph (J) to address additional duty requirement for the 

Person in Charge to ensure food employees are properly maintaining the temperatures 

of time/temperature control for safety foods during thawing and redesignated 

paragraphs (J) – (P) as new paragraphs (K) –(Q). 

Amended ¶ 2-103.11(N) (now ¶2-103.11(O) in the 2022 Food Code) to indicate what 

food allergy awareness includes. 

2-201.11

Amended sub¶ 2-201.11(D)(1) to remove cross reference to ¶ 2-201.12(G) to correctly 

indicate conditions under which the food employee should be excluded.

Amended sub¶ 2-201.11(D)(2) to add a cross reference to ¶ 2-201.12(G) to correctly 

indicate conditions under which the food employee should be restricted.

2-301.14

Amended ¶ 2-301.14(D) to include new term “tobacco products”.

2-401.11

Amended § 2-401.11 to revise title and paragraph (A) to include the new term “tobacco 

products”.

2-403.11

Amended ¶ 2-403.11(A) to include a new cross reference to ¶ 6-501.115(D) that 

addresses allowance for pet dogs in outdoor dining areas.

Chapter 3. Food

3-201.11

Amended ¶ 3-201.11(C) to remove the cross reference to § 3-202.17.

Amended sub¶ 3-201.11(E)(1) to indicate the type of steak to obtain from a food 

processing plant.

Amended sub¶ 3-201.11(E)(3)(a) to remove “labeled by” and replace with “received 

from a” to clarify what is received from a food processing plant.
FDA Food Code 2022 Annex 7: Model Forms, Guides, and Other Aids

Annex 7 -66

Amended to delete existing sub¶ 3-201.11(E)(3)(c) as it is no longer applicable to this 

paragraph.

3-202.17 / 3-202.18

Amended to re-number and merge § 3-202.17 with § 3-202.18 as the new § 3-202.18. 

Revised ¶ (A), added a new ¶ (B) and renumbered existing ¶ (B) to new ¶ (C) to clarify 

identification provisions under one section and removes redundant listing of all 

terms/forms/conditions of labeling/tagging and replaces with cross-reference to the 

model ordinance.

3-202.19

Amended § 3-202.19 to re-number as the new §3-202.17 to clarify flow of product from 

receipt through service and record keeping. Removed the term “shellfish” and replaced 

with “shellstock”. 

3-203.11

Amended § 3-203.11 to replace the term “Shellstock” with “Molluscan Shellfish”

throughout this section.

Amended ¶ 3-203.11(B) to include language from the previous sub¶ 3-203.12(C)(2)(b) 

to clarify prohibition of comingling in original containers. 

Amended ¶ 3-203.11(C) to include In-Shell Product.

Revised new ¶ 3-203.11(E) (old ¶ (3-203.11D) to update cross-reference § 3-202.17 in 

sub¶¶ (E)(1)-(2) to correctly indicate § 3-202.18.

Amended ¶¶ 3-203.11(B)-(D) to renumber as new ¶¶ (C) – (E).

3-203.12

Amended § 3-203.12 title and entire section to replace the phrase “Shellstock and 

Shucked Shellfish” with the term “Molluscan Shellfish”.

Amended ¶ 3-203.12(B) and (C) to include an invoice as appropriate documentation.

Amended ¶ 3-203.12 (C) to revise sub¶ 3-203.12 (C)(2)(a) and re-designate as the new 

sub¶ 3-203.12 (C)(1) and (2).

Amended sub¶ 3-203.12 (C)(2) to include in-shell product and shucked shellfish. 

Deleted sub¶ 3-203.12(C)(2)(b) and re-designated as the new ¶ 3-203.11(B).

3-204

Added new Subpart 3-204, Food Donation, under Part 3-2 Sources, Specifications, and 

Original Containers and Records.
FDA Food Code 2022 Annex 7: Model Forms, Guides, and Other Aids

Annex 7 -67

3-204.10

Added a new § 3-204.10 titled Food Donation, to indicate when food may be offered for 

donation.

3-302.11

Amended sub¶ 3-302.11(A)(1) to add an additional exception indicating instances when 

raw animal food does not need separation from RTE food. 

3-302.15

Amended ¶ 3-302.15(B) to include reference for the use of Produce Wash testing 

devices.

3-305.12

Amended ¶ 3-305.12(B) to revise risk designation from Core to Priority Foundation.

3-401.11

Revised sub¶ 3-401.11(A)(2) to delete the terms “mechanically tenderized” and 

“injected” and replace with the term “nonIntact meat”. Also removed the term “meats” 

from the listing of comminuted meats as it is already included by definition under the 

term nonIntact meat.

Amended sub¶ 3-401.11(C)(2) to align with the Food Safety and Inspection (FSIS) 

labeling requirements of mechanically tenderized beef products.

3-401.15

Amended to add a new § 3-401.15 addressing manufactured food cooking instructions. 

3-501.13

Amended sub¶ 3-501.13(C)(1) to add a new cross reference under Thawing to the new 

§ 3-401.15.

Amended ¶¶’s 3-501.13(A)-(C) to re-designate from a Core Item to a Priority Foundation 

(Pf) Item. 

Amend sub¶ 3-501.13(C)(1) to include new cross-reference to new § 3-401.15 

Manufacturer Cooking Instructions.

3-501.17

Amended sub¶ 3-501.17(G)(1) to update the existing cross reference of 21 CFR 110 

with 21 CFR 117.
FDA Food Code 2022 Annex 7: Model Forms, Guides, and Other Aids

Annex 7 -68

3-501.19

Added new sub-¶¶ (B)(2)(a), (b), (c), (d) to 3-501.19(B)(2) to address a READY-TO-EAT

produce or hermetically sealed FOOD that is rendered TIME/TEMPERATURE CONTROL FOR 

SAFETY FOOD upon cutting, chopping, or opening of a hermetically sealed container to 

begin at 21°C (70°F) or less and remain at 21°C (70°F) or less within a maximum of 4 

hours. 

Re-designated existing ¶¶ 3-501.19(B)(2)(3) and (4) as new ¶¶ 3-501.19(B)(3)(4) and 

(5) respectively. 

3-502.12

Amended to add new sub¶ 3-502;12(e)(iii) to address cook chill/sous vide products 

cooled to 5°C (41°F) in the sealed PACKAGE or bag as specified under §3-501.14 and

subsequently cooled to 1°C (34°F) and moved to 5°C (41°F) holding temperature and 

held for a max of 7 days. 

3-602.11

Amended sub¶ 3-602.11(C)(2) to add a cross reference to sub¶ 3-602.11(B)(5) to 

address major food allergen labeling in bulk food available for consumer self 

dispensing.

3-602.12

Amended to add new ¶ 3-602.12(C) to inform consumers of major food allergens in 

unpackaged foods via written means.

3-801.11

Amended ¶ 3-801.11(C) to add a new sub-¶ (4) with cross-reference to new § 3-401.15 

Manufacturer Cooking Instructions.

Chapter 4. Equipment, Utensils, and Linens

4-205.10

Amended § 4-205.10 to clarify that equipment that has been certified for conformance to 

an appropriate American National Standard is deemed to comply with the equipment 

sanitation provisions contained in Parts 4-1 and 4-2. 

4-303.11

Amended § 4-303.11 to add the risk designation of priority foundation (Pf) item that was 

inadvertently left off in the 2017 Food Code.
FDA Food Code 2022 Annex 7: Model Forms, Guides, and Other Aids

Annex 7 -69

4-401.11

Amended sub¶ 4-401.11 (A)(2) to revise risk designation from Core to Priority 

Foundation (

Pf) item.

4-903.12 

Amended sub¶ 4-903.12 (A)(2) to revise risk designation from Core to Priority 

Foundation (Pf) item.

Chapter 5. Water, Plumbing, and Waste

5-202.12

Amend ¶ 5-202.12(A) to revise the hot water temperature at the hand sink from at least 

38°C (100°F) to at least 29.4°C (85°F).

5-203.11

Amended § 5-203.11 to delete “¶(C)” and remove any reference to “¶(C)” in this section. 

Chapter 6. Physical Facilities

6-403.11

Amended ¶ 6-403.11(A) to include the new term “tobacco products”.

6-501.115

Amended § 6-501.115 Prohibiting Animals to add a new exception paragraph (D) to 

allow for pet dogs in outdoor dining areas, where approved.

Amended ¶ 6-501.115(A) to add a new cross reference to ¶ 6-501.115(D) to allow for 

pet dogs in outdoor dining areas, where approved.

Chapter 7. Poisonous or Toxic Materials

7-202.12

Amended sub¶ 7-202.12(B)(2) to remove “Restricted Use Pesticide” (RUP), as the 

definition of Poisonous or Toxic Materials has been revised to include RUP as the fifth 

category.

7-203.11

Amended to include the prohibition of storage of equipment, utensils, linens, singleservice, or single-use articles in containers previously used for storing toxic chemicals. 
FDA Food Code 2022 Annex 7: Model Forms, Guides, and Other Aids

Annex 7 -70

The section previously only mentioned the prohibition of storing food in these 

containers.

Chapter 8. Compliance and Enforcement

8-101.10

Amended ¶ 8-101.10(A) to include “or donated” in the application of this Code in public 

health protection.

8-103.12

Amended § 8-103.12 to include new ¶(A) addressing maintenance of APPROVED 

VARIANCE at the FOOD ESTABLISHMENT; Existing ¶¶ (A) and (B) renumbered to ¶¶ (B) and 

(C). 

8-201.12

Amended ¶8-201.12(C) as part of the sentence was inadvertently left off in the 2017 

Food Code.

8-201.14

Amended §8-201.14 to:

Delete sub¶ (C)(2) and add as new sub¶ (E)(2) that speaks to significant hazards for 

each critical control point

Delete sub¶¶ (C)(4) and (C)(5) and merge into newly revised ¶ (D) to highlight 

documents that should be submitted as a separate document

Redesignate existing ¶(D) as the new ¶(E) 

Redesignate existing sub¶(D)(5) as the new sub¶ (E)(5) and switched former ¶(E)(4) 

to follow, so the sequence in new sub¶(E) now follows the sequence of the HACCP 

Principles of monitoring, corrective actions and verification, where the 

subparagraphs are now sequenced as: 

(E)(4) establish monitoring procedures, 

(E)(5) establish corrective actions, 

(E)(6) establish verification procedures. 

Redesignated existing ¶(E) as new ¶(F) and existing ¶(F) as new ¶(G)

8-401.10

Amended sub¶ 8-401.10(B)(1) to reflect updated cross references due to the addition of 

a new ¶(A) in § 8-103.12. 
FDA Food Code 2022 Annex 7: Model Forms, Guides, and Other Aids

Annex 7 -71

Annex 1. Compliance and Enforcement

No Changes.

Annex 2. References

1-201.10

Amended to revise § 1-201.10 to update titles, web links and dates for the following 

references: 

#3 - Interactions Affecting the Proliferation and Control of Human Pathogens on 

Edible Plants.

#6 - Code of Federal Regulations, Title 9, Part 301. 2 Terminology; Adulteration 

and Misbranding Standards Definitions, Livestock. 

#7 - Code of Federal Regulations, Title 9, Section 590.5 Inspection of Eggs and 

Egg Products (Egg Products Inspection Act), Terms Defined.

#19 - Federal Register: May 7, 2001 (Volume 66, Number 88), Rules and 

Regulations, Pages 22899-22907, DEPARTMENT OF AGRICULTURE, Food 

Safety and Inspection Service, 9 CFR Parts 362 and 381, Docket No. 01-

045IF, RIN 0583-AC84, Mandatory Inspection Ratites and Squabs.

#20 - Food Allergen Labeling and Consumer Protection Act of 2004. Public Law 

108-282.

#22 - Food and Drug Administration/U. S. Public Health Service, 2020. National 

Shellfish Sanitation Program (NSSP).

#23 - Food and Drug Administration/U. S. Public Health Service, 2019 revision. 

Grade "A" Pasteurized Milk Ordinance.

#25 - Institute of Food Technologists (IFT) Report, Evaluation and Definition of 

Potentially Hazardous Foods, Food and Drug Administration Contract No. 

223-98-2333, Task Order No. 4, December 31, 2001.

#29 - Salmonella spp. and Listeria monocytogenes Risk Assessment for 

Production and Cooking of Blade Tenderized Beef Steaks. Kansas State 

University.

#30 - Hazard Analysis and Critical Control Point System.

Amended to revise § 1-201.10 to add new reference (#21 - Food Allergy Safety, 

Treatment, Education, and Research (FASTER) Act of 2021) and renumbered the 

subsequent references.

2-401.11 

Amended to revise § 2-401.11 title to include new term “tobacco products”.
FDA Food Code 2022 Annex 7: Model Forms, Guides, and Other Aids

Annex 7 -72

2-501.11

Amended to update reference list to include three new references (#2, #11, #12).

3-201.15

Amended to update web link and date for reference #1 National Shellfish Sanitation 

Program Guide for the Control of Molluscan Shellfish.

3-203.11

Amended to revise title from “Shellstock” to “Molluscan Shellfish, Original Container”.

3-203.12

Amended to revise title from “Shellstock” to “Molluscan Shellfish, Maintaining 

Identification”.

3-204.10

Amended to add new § 3-204.10 and 3 new corresponding references #1, #2 and #3.

3-401.11

Amended to update weblink for reference #9 “Draft Risk Assessment of the Public 

Health Impact of Escherichia coli O157:H7 in Ground Beef, Executive Summary”.

3-401.14

Amended to update weblink for reference #1 Appendix B, Compliance Guidelines for 

Cooling Heat-Treated Meat and Poultry Products (Stabilization).

3-501.17

Amended reference #5 Ready-to-Eat,Time/Temperature Control for Safety Food, Date 

Marking to update the title to 21 CFR 117.

Amended reference #19 USDA/FSIS Directive 10.240.4 to delete and re-number the 

remaining references. 

3-501.19

Amended to add five new references in support of the new exception in §3-501.19. 

Renumbered references alphabetically to align with existing references. 

3-502.12

Amended to update the weblink for reference #20 National Advisory Committee for 

Microbiological Criteria for Foods.
FDA Food Code 2022 Annex 7: Model Forms, Guides, and Other Aids

Annex 7 -73

3. Supporting Documents

Amended section K. Requirements and Guidance for Retail Facilities Regarding Beef 

Grinding Logs Tracking Supplier Information to update links and harmonize language 

based on recent FSIS publications.

Amended to add new section, W. Minimizing the Risk of Campylobacter and 

Salmonella Illnesses Associated with Chicken Livers. 

Amended to add new section X and update section title to Guidance Document for 

Direct-to-Consumer and Third-Party Delivery Service Food Delivery, 2019. 

Amended to add new section Y. Whole Roaster Pigs: Guidance for Safe Handling and 

Cooking.

Amended to add new section Z. National Shellfish Sanitation Program Guide for the 

Control of Molluscan Shellfish.

Annex 3. Public Health Reasons/Administrative Guidelines

1-201.10 

Amended to add Public Health Reasons for the term “Certification Number” as a new 

term and description to the alphabetical listing of terms. 

Amended to add Public Health Reasons for the term “In-Shell Product” as a new term 

and description to the alphabetical listing of the terms.

Amended to add Public Health Reasons for new defined term “Tobacco Product” after 

the public health reasons for the term “Time/Temperature Control for Safety Food”.

Amended Public Health Reasons for §1-201.10 (B) Terms Defined to add new 

paragraph 7 under the defined term “Time/Temperature Control for Safety Food” to 

include information about product assessments.

2-101.11

Amended Public Health Reason for §2-101.11 Assignment, to add new paragraph 3 that 

addresses newly added exception for ¶2-101.11(C). 

2-103.11

Amended Public Health Reasons for § 2-103.11 Person in Charge, to revise statement 

in paragraph 6 from “eight major food allergens” to “nine major food allergens”

Amended Public Health Reasons for §2-103.11 to add a new paragraph 8 addressing 

employee training on elements associated with food allergy awareness and what topics 

food establishments can consider including when developing operational- specific 

allergen training programs for employees. 
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Annex 7 -74

Amended Public Health Reasons for §2-103.11 to revise newly designated paragraph 9 

to correctly indicate paragraph (P) in the first sentence due to the newly redesignated 

paragraphs in §2-103.11.

Amended Public Health Reasons for §2-103.11 to address additional duty requirement 

for the Person in Charge to ensure food employees are properly maintaining the 

temperatures of time/temperature control for safety foods during thawing.

2-301.14 

Amended Public Health Reasons for §2-301.14 to reference new defined term “tobacco 

products”.

2-401.11 

Amended Public Health Reasons for § 2-401.11 to revise title to include new term 

“tobacco products”.

3-101.11 / 3-201.11

Amended Public Health Reasons for § 3-101.11 and § 3-201.11 to update paragraphs 

15-22 with revised weblinks and updated information regarding meat and poultry. 

Amended Public Health Reasons for § 3-201.11 to revise paragraph 24 to update 

information regarding labeling of steaks that are non-intact.

3-202.18

Amended to re-number and merge Public Health Reasons for § 3-202.17 with § 3-

202.18 as the new § 3-202.18. 

Amended Public Health Reasons for new § 3-202.18 to place descriptive paragraph 

from old § 3-202.18 as paragraph one.

Amended Public Health Reasons for § 3-202.18 to add new paragraph two and three to 

describe dual-purpose tags.

Amended Public Health Reasons for § 3-202.18 to place descriptive paragraph from old 

§ 3-202.17 as paragraph four.

3-202.19

Amended to delete existing Public Health Reasons for § 3-202.19 and re-number as the 

new § 3-202.17. 

3-203.11

Amended Public Health Reasons for § 3-203.11 paragraph 2 to update citation from § 

3-202.17 to § 3-202.18.
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Annex 7 -75

3-203.12

Amended Public Health Reasons for § 3-203.12 to revise title from “Shellstock, 

Maintaining Identification” to “Molluscan Shellfish, Maintaining Identification.

Amended Public Health Reasons for § 3-203.12 paragraphs 1-4 to replace the term 

“Shellstock” with “Molluscan Shellfish” wherever the term was used.

3-204.10 

Added new public health reasons for § 3-204.10 to address food donation compliance 

with law and Code applicability.

3-302.11

Amended Public Health Reasons for § 3-302.11 to revise paragraph 1 to include 

information on the additional exception provided in subparagraph (A)(1) indicating 

instances when raw animal food does not need separation from RTE food.

Amended Public Health Reasons for § 3-302.11 to revise paragraph 2 to appropriately 

characterize terminology from allergen cross contamination to allergen cross contact in 

the last sentence.

3-305.12

Amended Public Health Reasons for § 3-305.12 to add new paragraph 2 that provides 

reference to the public health reason for § 2-501.11.

3-401.11

Amended Public Health Reasons for § 3-401.11 to revise paragraphs 3, 10, 12-16 and 

add a new paragraph 11 to clarify and update information with revised FSIS policies.

3-401.15 

Added Public Health Reasons for new § 3-401.15 Manufacturer Cooking Instructions.

3-501.14

Amended Public Health Reasons for § 3-501.14 to revise paragraphs 12 -14 in the 

section addressing the CFSAN/FSIS Joint Position Paper on Cooling to update and 

harmonize with revised FSIS policies.

3-501.17

Amended Public Health Reasons for §3-501.17 Ready-to-Eat, Time/Temperature 

Control for Safety Food, Date Marking, to include reference to a fact sheet developed to 

assist industry and regulatory authorities to better understand the types of information 
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Annex 7 -76

that may be included on a date marking label and what the disposition time of that 

product looks like based on the information provided. 

Amended Public Health Reasons for § 3-501.17 to revise the weblink under the 

“FDA/USDA/CDC Listeria monocytogenes Risk Assessment” section in paragraph 1 for 

the Quantitative Assessment of the Relative Risk to Public Health form the Foodborne 

Listeria monocytogenes Among Selected Categories of Ready-to-Eat Foods. 

Amended Public Health Reasons for § 3-501.17 to revise the weblink under the “Hard 

and Semi-soft Cheeses” section in Paragraph 1 for FDA issuing an exemption from date 

marking for certain types of hard and semi-soft cheeses.

Amended Public Health Reasons for § 3-501.17 paragraph 10 (Deli Salads Prepared 

and Packaged in a Food Processing Plant) to update the existing cross reference of 21 

CFR 110 with 21 CFR 117.

3-501.19

Amended Public Health Reasons for §3-501.19 Time as a Public Health Control to add 

new paragraph 16 that addresses newly added exception for ¶3-501.19(B)(2). 

3-502.12

Amended Public Health Reasons for §3-502.12, Reduced Oxygen Packaging with One 

Barrier (Cook-Chill and Sous Vide) to indicate there are “four” options for cooling cookchill and sous vide TCS foods.

3-602.11

Amended Public Health Reasons for § 3-602.11 to revise paragraph 1 under the 

subheading ‘Food Allergen Labeling’ to clarify how FALCPA amended the FD&C Act 

and added a new paragraph 2 to provide information on the Food Allergy Safety, 

Treatment, Education, and Research Act of 2021 (FASTER Act). 

3-602.12

Amended Public Health Reasons for § 3-602.12 to add new paragraph 3 under the 

subheading “Food Labels and other forms of information” and added a new paragraph 2 

and revised existing paragraph 1 under the subheading “Food Allergen Labeling” to 

address the inclusion of written notification of major food allergens in unpackaged 

foods.

4-501.114

Amended Public Health Reasons in § 4-501.114 to clarify intent of paragraph 3 that 

formulation of food contact surface sanitizers is not limited to chlorine, iodine and 

quaternary ammonium compounds. 
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Annex 7 -77

5-202.12

Amended Public Health Reasons for ¶ 5-202.12(A) to revise paragraphs 1 and 2 to 

incorporate the revision from the hot water temperature at the hand sink from at least 

38°C (100°F) to at least 29.4°C (85°F).

6-501.115

Amended Public Health Reasons for §6-501.115 Prohibiting Animals to add new 

paragraph 6 that addresses allowance of pet dogs in outdoor dining areas, where 

approved. 

Annex 4. Management of Food Practices-Achieving Active Managerial Control of 

Foodborne Illness Risk Factors

Amended Section 3. The HACCP Principles, Category (A) (4) Food Allergens As Food 

Safety Hazards 

Amended paragraph 2 to add sesame to the list of major food allergens.

Amended paragraph 4 to clarify requirements that are included in FALCPA.

Added new paragraph 5 to indicate new requirements as a result of the FASTER 

Act.

Amended Annex 4, Tables 2a-b Common Chemical Hazards at Retail, Along with their 

Associated Foods and Control Measures

Amended Table 2a. to add “Sesame” in the Associated Foods box addressing 

allergens (foods containing or contacted by).

Amended Table 2b. to remove the columns associated with the flavor enhancer 

monosodium glutamate (MSG) from the table.

Amended paragraph 1 in Section 3. The HACCP Principles. Category (C) Principle #3: 

Establish Critical Limits (2) What are examples of critical limits to correctly reference the 

appropriate pH critical limit for the acidification of sushi rice.

Annex 5. Conducting Risk-Based Inspection

No Changes. 

Annex 6. Food Processing Criteria

Amended Section 2. Reduced Oxygen Packaging, Section (B) Definitions,

paragraph (B)(1) to delete the phrase “which have the air expelled”.
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Annex 7 -78

Annex 7. Models Forms, Guides, and Other Aids

Form 3-A Food Establishment Inspection Report

Amended Item #1 Supervision to include an additional compliance status of N/A 

to address new exception in ¶ 2-101.11(C). 

Amended Item #6 Proper eating, tasting, drinking or tobacco use to replace 

“tobacco use” with the new term “tobacco products”.

Amended to update Item #14 title to replace the term ‘shellstock tags” with 

“molluscan shellfish”.

Guide 3-B, Instructions for Marking the Food Establishment Inspection Report, 

Including Food Code References for Risk Factors/Interventions and Good Retail 

Practices

General Marking Instructions

Amended the Instructions for Marking the Food Establishment Report in 

Sections C (Risk Factors) and D (Good Retail Practices) to capture new or 

updated cross references based on changes made in this Supplement as 

follows:

Item #1

Amended Item #1 to include an additional compliance status of N/A to 

indicate that the item is not applicable for the facility.

Amended Item #1, PIC present, demonstrates knowledge, and performs 

duties to revise applicable code section for § 2-103.11 to include 

redesignated paragraphs (A)-(O) and (Q).

Item #3

Amended Item #3, Management and food employee knowledge, and 

conditional employee; responsibilities and reporting, to revise applicable code 

section for § 2-103.11 to update it to read as 2-103.11 (P) to match the

redesignated paragraph numbering in § 2-103.11.

Item #6

Amended Item #6, Proper, Eating, Tasting, Drinking or Tobacco Use to 

update the title to include the new term “tobacco products” and include 

tobacco products in the descriptive narrative and to update the applicable 

code sections to reflect the revised section title for 2-401.11 to include the 

new term “tobacco products”.

Item #11

Amended item #11, Approved Source, to rename the title to more 

appropriately state, “Food From a Source that Complies with Law”.

Amended Item #11 to make an editorial change to clarify the IN/OUT 

instructions that food must be obtained from sources that comply with Law. 
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Annex 7 -79

Item #14

Amended Item #14 Required records available: shellsotck tags, parasite 

destruction to revise title and descriptive language to replace the terms 

“shellstock tags” with “molluscan shellfish identification”.

Amended Item #14 Applicable Code Sections to replace the terms “shellstock 

tags” with “molluscan shellfish” where applicable.

Item #15

Amended Item #15 Food Separate and Protected to add additional 

parameters clarifying RTE food may be combined with raw animal food when 

combined as ingredients for future prep/cooking. 

Item #18

Amended Item #18 to update the IN/OUT marking instructions to add 

additional information about foods bearing manufacturer cooking instructions 

or a disclosure that the food has not been processed to control pathogens.

Amended Item #18 to update the table of “Internal Cooking Temperature 

Specifications for Raw Animal Foods” to denote the proper cooking 

time/temperatures under intact meat and to replace the terms mechanically 

tenderized and injected with nonIntact Meat to harmonize with the revised 

definition of Intact meat.

Amended Item #18, Proper cooking time and temperature to add a new 

Applicable Code Section: 3-401.15 Manufacturer Cooking Instructions.

Item #29

Amended Item #29 to reflect marking the inspection report Out of Compliance 

when the approved variance in ¶ 8-103.12(A) is not kept at the food 

establishment. 

Item #35

Amended Item #35 to revise the risk designation from a core item to a priority 

foundation item under the applicable code § 3-501.13 Thawing. 

Item #37

Amended Item #37, Food Properly Labeled, Original Container to add 

guidance that addresses bulk food available for consumer self-dispensing and 

labeling of major food allergens.

Amended Item #37, Food Properly labeled, Original Container to reflect new 

addition of consumer written notification of major food allergens as an 

ingredient in unpackaged foods.

Amended Item #37 Food properly Labeled; Original Container to remove 3-

202.17 as an applicable code section.
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Annex 7 -80

Item #39

Amended Item #39, Contamination prevented during food preparation, 

storage and display to add risk designation of Priority Foundation to 

applicable code section 3-305.12.

Amended Item #39 Contamination prevented during food preparation, storage 

and display to remove applicable code section 3-202.19 and replace with 

applicable code section 3-202.17.

Item #44

Amended Item #44, Utensils, equipment and linens; properly stored, dried 

and handled to add risk designation of Priority Foundation to applicable code 

section 4-903.12.

Item #47

Amended Item #47, Food and non-food contact surfaces cleanable, properly 

designed, constructed and used to add risk designation of Priority Foundation 

to applicable code section 4-401.11.

Item #48

Amended Item #48 to revise the title of § 4-501.110 under the applicable code 

sections, which was incorrectly written in the 2017 Food Code. 

Amended Item #48 to include § 4-501.116 Warewashing Equipment, 

Determining Chemical Sanitizer Concentration under the applicable code 

sections that was inadvertently missing in previous versions of the Food 

Code.

Chart 4-D FDA Food Code Mobile Food Establishment Matrix

Revised Chart 4-D FDA Food Code Mobile Food Establishment Matrix to delete 

reference of ¶ 5-203.11(C) from the following categories: “Personnel”, “Water & 

Sewage” to reflect the deletion made in § 5-203.11.