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Food Code

U.S. Public Health Service

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service • Food and Drug Administration

College Park, MD 20740

For public sale by:

U.S. Department of Commerce National Technical Information Service 5301 Shawnee Road, Alexandria, VA 22312 Phone: 1-800-553- refer to report number PB2013-

ISBN 978-1-935239-02-

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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-

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-

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-

1995 - Food Code, 1995 Recommendations of the United States Public Health Service, Food and Drug Administration, National Technical Information Service Publication PB95-

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INTRODUCTION to the 2013 FOOD CODE

The federal government is committed to enhanced coordination with state, local, and tribal agencies, and the food industry to protect our food supply, and the Food Code is one important element in this strategy. HHS and USDA will continue to take progressive steps to partner with all who have a stake in food safety, and are committed to reducing the incidence of foodbome illness in the United States.

This edition of the Food Code reflects our current understanding of evidenced-based practices for the effective control of microbiological, chemical and physical hazards in food facilities that can cause foodbome illness. Many of the changes to this edition reflect recommendations made at the 2012 biennial meeting of the Conference for Food Protection, a national organization that affords scientists and policy makers from all levels of government, industry, academia and consumers the opportunity to propose and deliberate on improvements to the Food Code.

As of 2012, all 50 states and 3 of 6 territories report having retail codes patterned after previous editions of the Food Code. We strongly encourage the adoption and implementation of the 2013 Food Code at all levels of government.

The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) of the U.S. Department of Health and Human Services (HHS) and the Food Safety and Inspection Service of the U.S. Department of Agriculture (USDA) are pleased to announce the release of the 2013 and eighth edition of the Food Code. The Food Code is a model code and reference document for state, city, county and tribal agencies that regulate operations such as restaurants, retail food stores, food vendors, and foodservice operations in institutions such as schools, hospitals, assisted living, nursing homes and child care centers. Food safety practices at these facilities play a critical role in preventing foodbome illness. The Food Code establishes practical, science-based guidance for mitigating risk factors that are known to cause or contribute to foodbome illness outbreaks associated with retail and foodservice establishments and is an important part of strengthening our nation's food protection system.

Margaret A. Hamburg, M.Vr Commissioner / / Food and Drug Administration U.S. Department of Health-and Human Services

Alfred V. ^im anza > Administrator Food Safety and Inspection Service U.S. Department of Agriculture

Thomas R. Frieden, M.D., M.P.H Director Centers for Disease Control and Prevention U.S. Department of Health and Human Services

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 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.

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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 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].

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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 2009 FDA Food Code and recommendations developed during the 2012 Biennial meeting of the Conference for Food Protection. The revisions also reflect input provided by 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 converted throughout the Code to meet web accessibility requirements under Section 508 of the Rehabilitation Act of 1973 ( 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.

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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.

In the 2009 FDA Food Code a revised designation system for Code provisions was introduced. In the 2013 edition of the FDA Food Code, Annex 7 Form 3-A Food Establishment Inspection Report and Guide 3-B Instructions for Marking the Food Establishment Inspection Report were updated to reflect the revised designation system.

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.

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. 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.

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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 rule- making authority to a governmental administrative agency; or

(C) Adopted as an ordinance, if the local legislative body has been delegated rule- making 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 Team, HFS-320, 5100 Paint Branch Parkway, College Park, MD 20740-3835. Refer to item 2. (A) of this Preface to access a listing of jurisdictions’ adoptions.

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.

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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- Subpart 9- Section (§) 9-101. 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 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

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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 certain food processes for use in evaluating proposed HACCP plans.

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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.

(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 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.

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