1. NATURE AND EXTENT OF FOODBORNE ILLNESS
Foodborne illness in the United States is a major cause of personal distress, preventable death, and avoidable economic burden. In 1994, the Council for Agricultural Science and Technology estimated 6.5 to 33 million people become ill from microorganisms in food, resulting in as many as 9,000 needless deaths every year.
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 is estimated to be in the billions of dollars. Federal researchers are currently evaluating and updating these costs.
The Centers for Disease Control and Prevention have consistently stated that where reported foodborne outbreaks were caused by mishandling of food, most of the time the mishandling occurred within the retail segment of the food industry (restaurants, markets, schools, churches, camps, institutions, and vending locations ) where ready-to-eat food is prepared and provided to the public for consumption.
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 12 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 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 - 1997 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 page iii. 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 under Federal/State Food Programs - Retail Food Safety References. 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.
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 (4)].
Under authority of the Economy Act, June 30, 1932 as amended [31 USC 1535], FDA provides assistance to federal agencies such as the General Services Administration and the Indian Health Service.
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 1997 Mission Statement the agency is responsible for ensuring that:
Foods are safe, wholesome, and sanitary...; regulated products are honestly, accurately, and informatively represented; and, these products are in compliance with the law and FDA regulations; noncompliance is identified and corrected; and any unsafe or unlawful products are removed from the marketplace.
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.
The Food Code addresses controls for risk factors identified by the Centers for Disease Control and Prevention as contributors to foodborne outbreaks that have been investigated and confirmed. Those factors are unsafe sources; inadequate cooking; improper holding; contaminated equipment; and poor personal hygiene. It further establishes 5 key public health interventions to protect consumer health, specifically, demonstration of knowledge; employee health controls; controlling hands as a vehicles.
4. ADVANTAGE OF UNIFORM STANDARDS
The advantages of well-written, scientifically sound, and up-to-date model codes have 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.
5. MODIFICATIONS AND IMPROVEMENTS IN THIS EDITION
The revisions contained in this edition largely reflect the recommendations developed during the 1998 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.
The needed clarifications and missing Code provisions were identified by FDA and others during standardization and certification activities, State Training Branch 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.
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 plan preapproval is not a part of another HACCP regulatory model, the Fish and Fishery Products regulation 21 CFR 123, effective December 18, 1997. Additionally, there are differences between the two models in the required content of the HACCP plan. For example, the HACCP plans mandated 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 potentially hazardous and for which retail production would otherwise be prohibited.
To assist food establishments in applying HACCP principles at retail, FDA has issued a draft 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.
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.
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.
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 and Interstate Travel Team, HFS-627, 200 C Street, SW, Washington, DC 20204-0001. Refer to 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. above 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 Inspection Guide (Annex 7) 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:
Section (§) 9-101.11
Paragraph (¶) 9-101.11(A)
Internal cross referencing is widely used throughout the document to eliminate the need for restating provisions. For example, fixtures and devices necessary for handwashing are relevant to both the plumbing (Chapter 5) and the facilities (Chapter 6) portions. To alert the reader to relevant information and provide a system by which each violation is recorded under the one most appropriate provision, the Code uses the phrase "...as specified under (followed by a Code cite such as a section or paragraph)." It must be determined within the context of the provision whether the cross reference simply provides information to explain the requirement or whether the observed violation is properly recorded against the provision that is cited after the word "under."
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, but are provided to convey relevant information about specific exceptions and alternative means for compliance.
Requirements contained in the Food Code are presented as being in one of 3 categories of importance: critical; "swing" (i.e., those that may or may not be critical depending on the circumstances); and noncritical. An asterisk * after a tagline (which is the language immediately following a section number that introduces the subject of the section) indicates that all of the provisions within that section are critical unless otherwise indicated, as follows:
Any provisions that are "swing" items, are followed by the bold, superscripted letter S and any provisions that are noncritical are followed by the bold, superscripted letter N.
Any unmarked provisions within a section that has an asterisked tagline are critical. All provisions following a tagline that is not marked with an asterisk are noncritical.
Defined words and terms are capitalized 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 capitalize 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.
9. THE CODE REVISION PROCESS
(A) Food Code Revision and Publication Cycles
FDA is revising the Food Code every 2 years. The revision will issue either as a supplement to the existing edition or as a new edition based on the extent of revision. Each new edition will incorporate the provisions of supplements issued between editions.
(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. above, 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.
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 whose contribution to public health and food safety via the Food Code will span well into the next century.