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April 2006
There is no doubt that you, the state, local, or tribal health inspector, play a significant role in reducing foodborne illness in your jurisdiction, yet your job can be overwhelming at times due to diminishing resources, increasing workload with limited staff, and growing liability. Many of you are continually forced to reassess your priorities due to increased media attention on food safety, threats from emerging pathogens, and food security, while being challenged to do more with less while maintaining your professional integrity.
Although the majority of these challenges are beyond your control, the allocation of your inspectional time is one element that you can change and continue to use to your advantage. You may undoubtedly become frustrated when you find the same violation at the same establishment, inspection after inspection. You may be able to change this pattern by focusing your inspection on the violations most likely to cause foodborne illness and by assisting retail and food service operators in the development or enhancement of food safety management systems to reduce the recurrence of these violations.
This Manual provides you with a manageable scheme for prioritizing your inspections using a risk-based approach. The traditional regulatory inspection places emphasis on assessing compliance with all applicable regulations. The same emphasis may be placed on structural violations of the code as those violations likely to lead to foodborne illness. Although this type of inspection has done a great deal to improve basic sanitation and to upgrade food facilities in the United States, it emphasizes reactive rather than preventive measures. The traditional regulatory inspection only seeks to obtain correction of food safety concerns that already exist, rather than to prevent future violations from occurring.
Each individual in the food chain from farmer to processor to retailer to consumer has some responsibility for food safety. The ultimate responsibility for food safety at the retail level lies not with the regulatory authority but with retail and food service operators and their ability to develop and maintain effective food safety management systems. Nevertheless, you can help industry with this responsibility by utilizing a risk-based inspection approach to identify strengths and weaknesses in their systems and suggesting possible solutions for improvement during inspections.
This Manual was written to provide a "roadmap" for evaluating retail and food service establishments based on the application of HACCP principles. The acronym "HACCP" stands for "Hazard Analysis and Critical Control Point." It is a preventive approach implemented by industry to control food safety hazards. Using HACCP principles during inspections will help to assist you in evaluating the effectiveness of food safety management systems implemented by industry.
The voluntary strategies presented in this Manual also foster food safety partnerships between you and your retail or food service operators, which will facilitate your active role in improving their existing food safety management systems. Please note that this Manual is not a comprehensive resource for learning about HACCP principles; therefore, you should have a basic understanding of the principles of HACCP before using this Manual. Annex 1 lists several resources that are available to you should you require a more comprehensive explanation of HACCP.
Many regulatory jurisdictions are already conducting risk-based inspections using HACCP principles and other innovative approaches. This Manual is based on experience gained from many of these approaches and is provided to you, the regulatory food safety professional, to help you enhance the effectiveness of your inspections by incorporating a risk-based approach.
In an ideal world, determining the effectiveness of a retail and food service regulatory program would be based on the occurrence of foodborne illness within that jurisdiction. The occurrence of foodborne illness is, however, underreported, making it an unreliable program measurement. As an alternative, the occurrence of foodborne illness risk factors can be used to gauge program effectiveness.
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."
The foodborne illness risk factors are:
Until recently, there were no standardized, systematically-compiled statistics for the incidence of occurrence of foodborne illness risk factors in retail or food service facilities. As a result, implementation of food safety management systems designed to improve conditions leading to out-of-control risk factors was difficult.
In 2000, FDA completed a project designed to fill this information void and published its results in the Report of the FDA Retail Food Program Database of Foodborne Illness Risk Factors. The report, commonly referred to as the "FDA Baseline Report," is provided to regulators and industry with the expectation that it will be used to focus greater attention and increased resources on the control of risk factors. A copy of the report is available from FDA through the following website: http://www.cfsan.fda.gov/~dms/retrsk.html.
The measurable trends identified in CDC's 1993 - 1997 Surveillance Report and in FDA's Baseline Report indicate that routine regulatory inspections should place an increased focus on assessing an establishment's active managerial control over the five CDC-identified risk factors.
The term "active managerial control" is used extensively throughout this Manual to describe industry's responsibility for developing and implementing food safety management systems to reduce the occurrence of foodborne illness risk factors. Although the term may be new to some, the basic management principles are probably already being used in the day-to-day operations of most of the establishments you regulate.
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 risk factors. Elements of an effective food safety management system may include the following:
For several decades, food safety professionals have recognized the importance of HACCP principles for controlling risk factors that directly contribute to foodborne illness. Within the retail and food service industries, the implementation of these science-based food safety management principles varies.
Many multi-unit corporations and institutions, as well as independent operators, have developed effective food safety management systems that incorporate the seven principles of HACCP. The FDA document, "Managing Food Safety: A Manual for the Voluntary Implementation of HACCP Principles for Operators of Food Service and Retail Establishments," is designed to aid industry in establishing effective, voluntary food safety management systems based on the principles of HACCP. The manual is available from FDA through the following website: http://www.cfsan.fda.gov/~dms/hret2toc.html.
The products made in retail and food service operations are as varied as the methods and processes used to make them. The resources available to retail and food service operators to help them with identifying and controlling the risk factors particular to their operations also vary. Due to this diversity, implementation of "textbook HACCP" is impractical in most retail and food service operations.
Like many other quality assurance programs, the principles of HACCP provide a common-sense approach to identifying and controlling "problems." Consequently, many food safety management systems at the retail level incorporate some, if not all, of the principles of HACCP. Given the diversity of retail and food service operations, however, it is important for you to recognize that there is more than one "correct" application of HACCP principles. Regulatory inspection programs must be flexible enough to operate in a complementary and effective manner in this dynamic retail environment.
The DRAFT FDA Voluntary National Retail Food Regulatory Program Standards establish a framework that regulatory agencies can use to -
The complete set of Program Standards is available from FDA through the following website: http://www.cfsan.fda.gov/~dms/ret-toc.html.
The ultimate 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. The goal of this Manual is to provide you with a practical, HACCP-based approach to evaluate industry's active managerial control of foodborne illness risk factors. It is essential that regulatory program managers design an inspection program based on HACCP principles that guides and supports their field staff in assisting operators with incorporating these principles into their routine activities. Since food safety management systems are designed by retail and food service operators to best meet their own needs, you will need to use a risk-based methodology during your inspections to uncover the systems being used and to evaluate their effectiveness.
