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April 2006
"Foodborne illness in the United States is a major cause of personal distress, preventable death, and avoidable economic burden. Mead et al. (1999) estimated that foodborne diseases cause 76 million illnesses, 325,000 hospitalizations, and 5,000 deaths in the United States each year... The annual cost of foodborne illness in terms of pain and suffering, reduced productivity, and medical costs is estimated to be $10-83 billion."
2001 Food Code
Public Health Service - Food & Drug Administration
U.S. Department of Health and Human Services
The statistics on foodborne illness speak for themselves. Regulatory officials and the retail and food service industries they regulate must partner with each other if we are to prevent or reduce foodborne illness. This Manual was prepared by the United States Food and Drug Administration (FDA), in partnership with federal, state, and local regulators, industry, academia, and consumers, to assist you, the operators of retail and food service establishments, in your efforts to produce safe food.
"Delivering safe food to the dinner table is the culmination of the work of many people. Producers, shippers, processors, distributors, handlers, and numerous others perform actions every day that may affect the safety of our food. Everyone's challenge is to perform these individual actions as well as possible, so that the food Americans eat is free from physical hazards and dangerous levels of pathogenic microorganisms and hazardous chemicals."
2001 Food Safety Strategic Plan
GOAL 2 - RISK MANAGEMENT
The President's Council on Food Safety
http://www.foodsafety.gov/~fsg/cstrpl-4.html#chap2
While every player in the flow of food from farm to table has some degree of responsibility for food safety, you are usually the last line of defense before food reaches the consumer. Because of this, you have a significant share of the responsibility for ensuring safe food. By voluntarily developing a food safety management system, you can better ensure that the foods served or sold in your establishment are safe.
Regulatory food inspection programs provide you with feedback on how well you are controlling certain conditions in your establishment that can lead to foodborne illness. Although your inspector can offer suggestions for how you can improve conditions in your establishment, he or she cannot possibly oversee every activity or function in your day-to-day operation. Given this limitation, you clearly have the greatest impact on food safety.
"Voluntary approaches can complement regulatory programs, particularly where government actions enhance existing incentives for individuals to adopt practices that increase food safety. Other approaches rely on the power of information to influence behavior. Such voluntary, prevention-oriented approaches will have a greater chance of success if they are promoted in partnership with the affected stakeholders"
2001 Food Safety Strategic Plan
The President's Council on Food Safety
This Manual provides you with a "roadmap" for writing and voluntarily implementing a food safety management system based on Hazard Analysis and Critical Control Point (HACCP) principles. By voluntarily developing and implementing a food safety management system like the one suggested in this Manual, you can take a proactive role in ensuring that the food served or sold in your establishment is safe. Rather than responding to a foodborne illness when it occurs, you can prevent it by taking active steps to eliminate, prevent, or reduce to an acceptable level food safety hazards that cause someone to be sick or injured.
If you already have an existing food safety management system, you may use the concepts in this Manual to upgrade the system you have in place. Whether you are developing a new food safety management system or merely upgrading the one you currently have, this Manual encourages operators and regulators of retail and food service to partner together to make the greatest impact on food safety.
The procedures and information presented in this manual were prepared with feedback received from regional FDA food safety seminars and Food Safety Initiative grassroots meetings. In addition, the Conference for Food Protection (CFP) has reviewed and endorsed this guidance and has provided FDA with comments and suggestions on two separate occasions (in December 2001 and again in November 2002). Comments received from these reviews were incorporated into this document by the FDA.
Although this document was written by FDA, your respective state, local, or tribal government directly regulates your operation. Understand that the requirements of your regulatory authority may not be the same as what is recommended in the model FDA Food Code. The 2001 FDA Food Code is used as the basis of this document, but it is neither federal law nor federal regulation. It also does not supercede the requirements of your state, local, or tribal government. However, most states have adopted the Food Code to regulate retail and food service establishments under their jurisdiction since 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. With this in mind, you should compare the requirements of your state, local, or tribal government with any Food Code requirements mentioned in this Manual to make sure they are consistent with one another.
The Food Code clearly establishes that the implementation of HACCP at retail should be a voluntary effort by industry. If, however, you plan on conducting certain specialized processes that carry considerably high risk, you should consult your regulatory authority to see if you are required to have a HACCP plan. Examples of specialized processes covered in Chapter 3 of the Food Code include formulating a food so that it is not potentially hazardous or using performance standards to control food safety.
Federal performance standards define public food safety expectations for a product usually in terms of the number of disease-causing microorganisms that need to be destroyed through a process. For example, instead of cooking chicken to 165°F for 15 seconds as dictated in the Food Code, performance standards allow you to use a different combination of time and temperature as long as the same level of public safety is achieved. Use of performance standards allows you to use innovative approaches in producing safe products.
When using performance standards or when conducting other specialized processes, the FDA Food Code requires an establishment to obtain a variance, or exemption from the requirements of the Code, and to implement a more comprehensive HACCP plan than is outlined in this Manual. The regulatory authority must not only approve this HACCP plan, but records generated in support of the plan must be made available for review when requested.
Jurisdictions that have not adopted the Food Code, but otherwise allow the use of performance standards or other specialized processing methods, may also require you to obtain a variance. In such cases, the regulatory authority may also require that you develop a more comprehensive HACCP plan than is outlined in this Manual. In some jurisdictions around the country, the implementation of HACCP programs is a requirement regardless of the processing methods used. You should consult your regulatory authority if you are unsure of your requirements, if you plan on deviating from the requirements, or if you plan on conducting specialized processes.
This Manual should be used in consultation with your federal, state, local, or tribal regulatory authority or other food safety professionals. Your regulatory authority can be an important resource in the development of your food safety management system. Regulatory food safety professionals can provide important information about the public health rationale for controlling a particular food safety hazard.
It is recommended that you use the latest version of the FDA Food Code, if applicable, or a copy of your local or state regulations as a reference. Many of the requirements in the Food Code or your local or state regulations provide fundamental prerequisites to implementing a food safety management system based on HACCP principles. If you do not have a copy of the Food Code, you can refer to Annex 1 of this Manual for information on how to obtain a copy. It is also available on the FDA/Center for Food Safety and Applied Nutrition website at: http://www.cfsan.fda.gov/~ear/retail.html.
Unlike many food processing operations, the retail and food service industries are not easily defined by specific commodities or conditions. These establishments share the following characteristics:
The following is a partial listing of the types of businesses that are usually considered part of the retail and food service industries:
Hazards are biological, physical, or chemical properties that may cause food to be unsafe for human consumption. The goal of a food safety management system is to control certain factors that lead to out-of-control hazards.
Because many foods are agricultural products and have started their journey to your door as animals and plants raised in the environment, they may contain microscopic organisms. Some of these organisms are pathogens which means that under the right conditions and in the right numbers, they can make someone who eats them sick. Raw animal foods such as meat, poultry, fish, shellfish, and eggs often carry bacteria, viruses, or parasites that can be harmful to humans.
Food can become contaminated by toxic chemicals or toxins in your establishment or in the environment. Physical objects may also contaminate food and cause injury. Food may become naturally contaminated from the soil in which it is grown or from harvest, storage, or transportation practices. Some foods undergo further processing and at times, despite best efforts, become contaminated. These inherent hazards, along with the hazards that may be introduced in your establishment such as metal fragments from grinding can lead to injury, illness, or death. Hazards are a huge threat to your business. Think of hazards as ticking bombs in your establishment. Unless they are kept under control, they could result in financial ruin for your business.
Hazards include -
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:
No national baseline on the occurrence of foodborne illness risk factors was available until 2000 when FDA released 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 foodborne illness risk factors. A copy of the report is available from FDA through the following website: http://www.cfsan.fda.gov/~dms/retrskfl.html.
Based on the measurable trends identified in CDC's 1993-1997 Surveillance Report and in FDA's Baseline Report, FDA recommends that your food safety management system focus on establishing active managerial control of the five CDC-identified risk factors.
The term "active managerial control" is used extensively throughout this document to describe your role for developing and implementing a food safety management system to reduce the occurrence of risk factors. Although the term "active managerial control" may be new to some, the basic management principles are probably already being used in your day-to-day operations.
Active managerial control means the purposeful incorporation of specific actions or procedures by industry management into the operation of your business to attain control over foodborne illness risk factors. It embodies a preventive rather than reactive approach to food safety. Having active managerial control includes having procedures in place for controlling identified foodborne illness risk factors through a continuous system of monitoring and verification.
FDA recognizes that there are many management systems that you can voluntarily implement to achieve active managerial control of risk factors. This Manual focuses only on the voluntary implementation of HACCP principles in your food safety management system. Regardless of the system you use, effective elements of a food safety management system may include -
Since the 1960's, food safety professionals have recognized the importance of HACCP principles for controlling risk factors that directly contribute to foodborne illness. The principles of HACCP embody the concept of active managerial control by encouraging participation in a system that ensures foodborne illness risk factors are controlled.
HACCP is not a stand-alone program, but is built upon a foundation of operational practices called prerequisite programs (discussed in Chapter 3). The success of a HACCP program (or plan) is dependent upon both facilities and people. The facilities and equipment should be designed to facilitate safe food preparation and handling practices by employees. Furthermore, FDA recommends that managers and employees be properly motivated and trained if a HACCP program is to successfully reduce the occurrence of foodborne illness risk factors. Instilling food worker and management commitment and dealing with problems like high employee turnover and communication barriers should be considered when designing a food safety management system based on HACCP principles.
Properly implemented, a food safety management system based on HACCP principles may offer you the following other advantages:
The 1997 National Advisory Committee for the Microbiological Criteria for Foods (NACMCF) recommendations updated the seven HACCP principles to include the following:
Perform a Hazard Analysis. The first principle is about understanding the operation and determining what food safety hazards are likely to occur. The manager needs to understand how the people, equipment, methods, and foods all affect each other. The processes and procedures used to prepare the food are also considered. This usually involves defining the operational steps (receiving, storage, preparation, cooking, etc.) that occur as food enters and moves through the operation. Additionally, this step involves determining the control measures that can be used to eliminate, prevent, or reduce food safety hazards. Control measures include such activities as implementation of employee health policies to restrict or exclude ill employees and proper handwashing.
Decide on the Critical Control Points (CCPs). Once the control measures in principle #1 are determined, it is necessary to identify which of the control measures are absolutely essential to ensuring safe food. An operational step where control can be applied and is essential for ensuring that a food safety hazard is eliminated, prevented or reduced to an acceptable level is a critical control point (CCP). When determining whether a certain step is a CCP, if there is a later step that will prevent, reduce, or eliminate a hazard to an acceptable level, then the former step is not a CCP. It is important to know that not all steps are CCPs. Generally, there are only a few CCPs in each food preparation process because CCPs involve only those steps that are absolutely essential to food safety.
Determine the Critical Limits. Each CCP must have boundaries that define safety. Critical limits are the parameters that must be achieved to control a food safety hazard. For example, when cooking pork chops, the Food Code sets the critical limit at 145°F for 15 seconds. When critical limits are not met, the food may not be safe. Critical limits are measurable and observable.
Establish Procedures to Monitor CCPs. Once CCPs and critical limits have been determined, someone needs to keep track of the CCPs as the food flows through the operation. Monitoring involves making direct observations or measurements to see that the CCPs are kept under control by adhering to the established critical limits.
Establish Corrective Actions. While monitoring CCPs, occasionally the process or procedure will fail to meet the established critical limits. This step establishes a plan for what happens when a critical limit has not been met at a CCP. The operator decides what the actions will be, communicates those actions to the employees, and trains them in making the right decisions. This preventive approach is the heart of HACCP. Problems will arise, but you need to find them and correct them before they cause illness or injury.
Establish Verification Procedures. This principle is about making sure that the system is scientifically-sound to effectively control the hazards. In addition, this step ensures that the system is operating according to what is specified in the plan. Designated individuals like the manager periodically make observations of employees' monitoring activities, calibrate equipment and temperature measuring devices, review records/actions, and discuss procedures with the employees. All of these activities are for the purpose of ensuring that the HACCP plan is addressing the food safety concerns and, if not, checking to see if it needs to be modified or improved.
Establish a Record Keeping System. There are certain written records or kinds of documentation that are needed in order to verify that the system is working. These records will normally involve the HACCP plan itself and any monitoring, corrective action, or calibration records produced in the operation of a the HACCP system. Verification records may also be included. Records maintained in a HACCP system serve to document that an ongoing, effective system is in place. Record keeping should be as simple as possible in order to make it more likely that employees will have the time to keep the records.
Within the retail and food service industries, the implementation of HACCP principles varies as much as the products produced. The resources available to help you identify and control risk factors common to your operation may also be limited. Due to this diversity, implementation of "textbook" HACCP is impractical in most retail and food service establishments.
Like many other quality assurance programs, the principles of HACCP provide a common-sense approach to identifying and controlling risk factors. Consequently, many food safety management systems at the retail level incorporate some, if not all, of the principles of HACCP. While a complete HACCP system is ideal, many different types of food safety management systems may be implemented to control risk factors. It is also important to recognize that HACCP has no single correct application. Variations in the procedures presented in this Manual are appropriate as long as they are based on sound public health judgment. In addition to the material presented in the text of this Manual, several references have been provided in Annex 1 to assist you in developing a food safety management system specific to your operation.
FDA endorses the voluntary implementation of food safety management systems in retail and food service establishments. Combined with good basic sanitation, a solid employee training program, and other prerequisite programs, HACCP can provide you and your employees a complete food safety management system.
The goal in applying HACCP principles in retail and food service is to have you, the operator, take purposeful actions to ensure safe food. You and your regulatory authority have a common objective in mind - providing safe, quality food to consumers. Your health inspector can help you achieve this common objective, but remember that the ultimate responsibility for food safety at the retail level lies with you and your ability to develop and maintain an effective food safety management system.
Managing food safety should be as fully integrated into your operation as those actions that you might take to open in the morning, ensure a profit, or manage cash flow. By putting in place an active, ongoing system, made up of actions intended to create the desired outcome, you can achieve your goal of improving food safety. The application of the HACCP principles provides one system that can help you accomplish that goal.
This Manual will provide details on how to organize your products so that you can voluntarily develop your own food safety management system using HACCP principles. The HACCP plans that you will develop using this Manual, in combination with prerequisite programs (discussed in Chapter 3), will constitute a complete food safety management system. Partnering with your regulatory authority or other food safety professional is recommended, but the design, implementation, and success of your system rests with you.
