Chapter 1 Introduction

Purpose and Scope Background Risks Associated with Foods Figure 1: Risk Factors Defining Retail Using HACCP Principles at Retail to Manage and Enhance Food Safety Overview of the Process Approach Summary

PURPOSE AND SCOPE

This Guide has been prepared by the United States Food and Drug Administration (FDA) based on input from state and local regulators, industry, academia, and consumers for the purpose of assisting operators and employees of food establishments at the retail level in their efforts to produce safe food. The portion of this Chapter "Defining Retail" is included to further describe the Scope of this Guide. Within this document, facilities that are considered in its scope are referred to either as "food establishments" or "retail food establishments."

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. Your 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. If you do not have a copy of the Food Code, refer to Chapter 6, FDA Publications & Federal Regulations, p. 62, for information on how to obtain a copy.

BACKGROUND

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 Chapter 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 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 which play a key role in any preventive strategy.

"Both parts of HACCP - the hazard analysis and the critical control points - are influenced by the design of equipment and structures in retail food establishments.... Facility and process designs can help a HACCP system be more effective by preventing cross contamination and meeting Standard Operating Procedures (SOPs), therefore allowing the hazard analysis to focus on significant hazards associated with the food itself."

(Comments made by FDA HACCP Policy Strategic Manager, Dr. John Kvenberg, on June 24, 1996 to the Institute of Food Technologists' seminar on Legal Constraints in Facility/Process Design).

Risks Associated with Foods

As stated in the Food Code:

"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.... The Centers for Disease Control and Prevention (CDC) 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 . . . where ready-to-eat food is prepared and provided to the public for consumption."

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. Many foods contain nutrients that make them a place where microorganisms can live and even grow. 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 ill. Raw animal foods such as meat, poultry, fish, and eggs often carry bacteria, viruses, or parasites that can be harmful to humans.

Also because foods are from the environment, they can contain objects such as stones that could cause injury. Food may be contaminated naturally, for example from the soil in which it is grown or because of 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 occur in your establishment, such as metal fragments from grinding, can lead to injury, illness, or death.

Hazards include:

• Biological concerns, such as:
  • bacterial, parasitic, or viral contamination
  • bacterial growth
  • bacterial, parasitic, or viral survival
  • bacterial toxin production
  • bacterial, parasitic, or viral cross-contamination

• Physical objects
  • stones
  • glass
  • metal fragments
  • packaging materials

• Chemical contamination
  • nonfood-grade lubricants
  • cleaning compounds
  • food additives
  • insecticides

In a report from CDC titled, Surveillance for Foodborne-Disease Outbreaks - United States, 1988-1992, it is clear that bacterial agents are the leading cause of laboratory-confirmed outbreaks and that the main reasons for the outbreaks are:

• improper holding temperatures,
• poor personal hygiene,
• improper cooking temperatures,
• foods from unsafe sources, and
• contaminated equipment.

Defining Retail

As stated in Chapter 1, Introduction, this document uses the terms "food establishments" and "retail food establishments" interchangeably. For a definition of a "food establishment" refer to Chapter 5 - Glossary.

Unlike industries such as canning, other food processing, and dairy plants, the "retail" industry is not easily defined by specific commodities or conditions. The following is a partial listing of the types of businesses that are usually considered part of the retail food industry. There are many situations which may include more than one type of operation.

Consider also the following characteristics that retail food establishments share.

1. The industry has a wide range of employee resources, from highly trained executive chefs to entry level front line employees. Employees may have a broad range of educational levels and communication skills. It may be difficult to conduct in-house training and to maintain a trained staff because employees may speak different languages or there may be high employee turnover.

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. Suppliers, ingredients, menu items, or specifications may change frequently.

Using HACCP Principles at Retail to Manage and Enhance Food Safety

The goal in applying the HACCP principles at retail is to have MANAGERS AND OWNERS of establishments voluntarily take purposeful actions to ensure a safe outcome. Managing for food safety must be as fully integrated into your operations as those actions that you might take to open in the morning, ensure a profit and manage cash flow, oversee personnel, or any other aspect of your business. Only by putting in place an active, ongoing system, made up of actions intended to create the desired outcome, can you improve food safety. Application of the HACCP principles provides one system that can meet that criterion.

The HACCP principles, combined with a good set of Standard Operating Procedures (SOPs) and a sound training program, can be the most important part of a food safety management system. The HACCP plan that you are going to develop is YOUR PLAN. You may seek assistance from others such as your regulatory authority or an outside consultant, but the design, implementation, and success of the plan rests with you.

You will notice in various parts of this Guide, e.g., in Procedural Step 3, and in the Operational Steps: Preparation and Set Up and Packaging, that the Guide speaks inconclusively to the method of controlling personal hygiene and bare hand contact with ready-to-eat food. The distinction focuses on whether such hazards should be considered part of a prerequisite program and managed through SOPs or as critical control points.

The HACCP system is defined by seven principles.

1. Perform a Hazard Analysis. This first principle is about understanding your operation and determining what hazards are likely to occur. This usually involves defining the operational steps that you take as food enters and moves through your business. At this point, you will also try to understand how the people, equipment, methods, and foods all affect each other.

2. Decide on the Critical Control Points (CCPs). Which of the operational steps identified in principle #1 are critical to a safe outcome? Where can a hazard be prevented, eliminated, or reduced to an acceptable level? Which actions positively, absolutely, have to happen right? Is there a later step that will prevent, reduce, or eliminate the hazard? It is important to know that not all steps are CCPs. Generally, there are only a few CCPs in each process.

3. Determine the Critical Limits. Each CCP must have boundaries that define safety. How will you know when the CCPs are under control? What are the regulatory standards? What will you measure against? Critical limits are the measurements that define safety and can usually be found in the Food Code. For example, for cooking hamburgers, the Food Code sets the critical limits at 155°F for 15 seconds. When critical limits are not met, it could mean that the food is not safe.

4. Establish Procedures to Monitor CCPs. Once you have decided which operational steps are critical and have set the critical limits, someone needs to keep track of the CCPs in the flow of foods through your operation. Monitoring involves finding a way to see that the CCPs are kept under control and within the critical limits.

5. Establish Corrective Actions. What will you do when things go wrong? When monitoring your CCPs you will occasionally find an operational step that is outside of your critical limits. You need to plan ahead and decide what your actions will be, communicate those to your employees, and train them in those decisions. This preventive approach is at the heart of HACCP. Problems will arise. You need to find them and correct them before they can cause someone to become ill or injured.

6. Establish Verification Procedures. This principle is all about making sure that the whole system is in place and working. You will want to periodically make observations, calibrate equipment and temperature measuring devices, review records / actions, and discuss procedures with your employees. All of these activities will be for the purpose of ensuring that your system is real and checking to see if it needs to be modified or improved. Verification may also be conducted from the outside, such as by the regulatory authority or a third party.

7. Establish a Record Keeping System. There are certain written records or kinds of documentation that will be needed in order to verify that the system is working. Refer to the following table for examples of simplified "records." These records will normally involve the HACCP plan, itself, and your monitoring activities and serve to document that you really do have an on-going system 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 them.

For more than 20 years industry and regulators have been exploring use of the HACCP principles in restaurants, grocery stores, and other retail food establishments. During that time, much has been learned about how these principles can be used in the 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 definitions of HACCP and still make the principles useful to an industry that encompasses the broadest range of conditions.

Despite this diversity and range of conditions, those involved have discovered that the HACCP principles are useful tools for managing food safety. Over time, ways have been discovered to slightly modify the applications of HACCP to better fit retail food establishments. The following chart suggests some adaptations of applying the HACCP principles to retail food establishments.

HACCP Principle	Applications Specific to Retail Level Food Establishments
Hazard Analysis	Analyze and organize by process rather than commodity because food items are intertwined in retail operations. Simplify by combining like operations into categories.
Define Critical Control Points	No change.
Establish Critical Limits	No change. Use of Food Code provisions.
Monitor	Simplify monitoring by standardizing procedures to a level of confidence that ensures safety, detects problems, and reduces the monitoring frequency.
Corrective Actions	No change.
Verification	No change.
Record Keeping	Simplify by using records already in existence, such as invoices, work schedules, and recipes.

Overview of the Process Approach

When conducting the hazard analysis, food manufacturers usually use food commodities as an organizational tool and follow the flow of one product. This is a very useful approach for producers or processors, since they are usually handling one product at a time. But at retail, foods of all types are worked together to produce the final product or menu item. This makes a different approach to the hazard analysis necessary. Conducting the hazard analysis by using the methods or processes common to a specific operation seems to work quite well. This is called the "Process Approach."

The process approach to the use of HACCP principles can best be described as dividing the many flows in an establishment into broad categories, analyzing the risks, and placing managerial controls on each grouping. The food that flows through retail food establishment operations can be placed into the three following processes:

Receive - Prepare - Serve
(other processes may occur, but there is NO cooking step)

Receive - Prepare - Cook - Hold - Serve

(other processes may occur, including thawing)

Receive - Prepare - Cook - Cool - Reheat - Hot Hold - Serve

(other processes may occur, but the key is repeated trips through the temperature danger zone)

Your HACCP system must provide food safety controls for all hazards within each of these processes. Some operational steps, such as cooking, require procedures to control various hazards related to several different products. Therefore, a single operational step may have multiple control limits for multiple, product-specific hazards. For example, at the cooking step, poultry requires a final internal cooking temperature of 165°F for 15 seconds to control for Salmonellae. Ground beef, however, requires a final cooking temperature of 155°F for 15 seconds to control for E. coli 0157:H7.

At the same time, some process steps, such as refrigerated storage, may encompass food safety procedures and critical limits that apply to all foods at that point in the flow of food.

Based on this understanding, you can blend a product-specific or menu-item HACCP approach into a process-oriented approach. Controlling the hazard within each of these processes is equivalent to preparing a HACCP plan for each individual product, often a time- and labor-intensive job.

SUMMARY

HACCP is endorsed by the Food and Drug Administration. Combined with basic sanitation and a solid employee training program (prerequisite to the implementation of the HACCP principles), HACCP can provide the operator and employees a complete food safety management system.

The rest of this Guide will provide enough detail about how to organize your menu items so that you can voluntarily develop your own food safety system by applying the HACCP principles. It is important to remember that there are many resources that you can draw on during your efforts and some of these are listed at the end of this Guide. As mentioned in the Purpose and Scope portion of this Chapter, while setting up your food safety system using the HACCP principles, you are encouraged to contact your regulatory authority for advice and assistance.

NOTICE: This is a Draft document to guide operators in voluntarily applying HACCP principles in food establishments in the retail segment. It will be trial tested in a structured FDA pilot. The pilot, Notice of which will appear in the Federal Register, is an open process and as experience is gained from the various phases of that pilot, this Guide will be modified. 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. The Guide will continue to evolve and improve. It is anticipated that the field application of this guidance document will identify additional processes, special food considerations, or other facets of a HACCP program that need to be addressed. It is also expected, as reflected in the Annex, that the listing of commodity-specific hazards will be expande developing their HACCP systems. The Agency fully recognizes the diversity of "retail food 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 identifying realistic and useful ways of making it happen that are customized to the operation. FDA is open to record keeping applications that minimize the burden of instituting a HACCP system while providing the added consumer protection. FDA is most interested in receiving comments from parties who may review or use this Guide either within the pilot program or outside of that process. Of particular interest to the Agency are alternative ways of controlling hazards, input regarding special food considerations as described in Annex 2, and specific comments with respect to providing additional practical HACCP guidance for the retail industry. To submit comments, please photocopy the pages of concern, mark them up with your suggested changes, and forward them to: Dr. John E. Kvenberg HACCP Policy Strategic Manager (HFS-10) Office of Policy, Planning and Strategic Initiatives Food and Drug Administration 200 C Street, S. W. Washington, DC 20204