FDA 2001 Food Code - Annex 5: HACCP Guidelines (Part 01)

FDA 2001 Food Code - Annex 5: HACCP Guidelines

U. S. Department of Health and Human Services
Public Health Service
Food and Drug Administration
2001 Food Code (Updated April 2004*)
Supplement to the 2001 Food Code

Annex
5
    HACCP Guidelines

 NOTE: Annex 5 is currently being reviewed and revised to reflect FDA's current thinking. The information contained herein is likely to change when the next Food Code is issued.

1. INTRODUCTION
2. HACCP PRINCIPLES
3. SUMMARY
4. ACKNOWLEDGMENTS
5. BIBLIOGRAPHY
6. OTHER SOURCES OF HACCP INFORMATION

1. INTRODUCTION

HACCP (Hazard Analysis and Critical Control Point) is a systematic approach in identifying, evaluating and controlling food safety hazards. Food safety hazards are biological, chemical or physical agents that are reasonably likely to cause illness or injury int he absence of their control. A HACCP system is a preventive system of hazard control rather than a reactive one. HACCP systems are designed to prevent the occurrence of potential food safety problems. This is achieved by assessing the inherent hazards attributable to a product or a process, determining the necessary steps that will control the identified hazards, and implementing active managerial control practices to ensure that the hazards are eliminated or minimized.

Essentially, HACCP is a system that identifies and monitors specific foodborne hazards - biological, chemical, or physical properties - that can adversely affect the safety of the food product. This hazard analysis serves as the basis for establishing critical control points (CCPs). CCPs identify those points in the process that must be controlled to ensure the safety of the food. Further, critical limits are established that document the appropriate parameters that must be met at each CCP. Monitoring and verification steps are
included in the system, again, to ensure that potential hazards are controlled. The hazard analysis, critical control points, critical limits, and monitoring and verification steps are documented in a HACCP plan. Seven principles have been developed which provide guidance on the development of an effective HACCP plan.

HACCP represents an important food protection tool supported by Standard Operating Procedures, employee training and other prerequisite programs that small independent businesses as well as national companies can implement to achieve active managerial control of hazards associated with foods. Employee training is key to successful implementation. Employees must learn which control points are critical in an operation and what the critical limits are at these points, for each preparation step they perform. Establishment management must also follow through by routinely monitoring the food operation to verify that employees are keeping the process under control by complying with the critical limits.

Local jurisdictions can effectively promote the industry's use of HACCP and apply the concepts during inspections. The implementation of HACCP continues to evolve as hazards and their control measures are more clearly defined. To meet the challenges presented by advances in food research, product development, and their impact at retail, regulatory personnel must keep themselves informed. Food protection publications issued by the food industry, professional organizations, and other groups and continuing education programs can be particularly helpful in providing an understanding of food operations and how the application of HACCP can bring a focus to food safety that traditional inspection methods have lacked.

FDA has issued guidance to industry in voluntarily applying HACCP principles in food establishments. The 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" is discussed in Annex 2, 3. This Guide recognizes that there are differences between using a HACCP plan in food manufacturing plants. By incorporating the seven principles of HACCP, a good set of Standard Operating Procedures, and using a process approach, this Guide sets up a framework for the retail food industry to develop and implement a sound food safety management system. The Agency recognizes that this document has areas that need to be further clarified, developed with broader input, and based on industry's experiences with the practicalities of integrating the HACCP approach in their operations. This Guide will continue to evolve and improve.

FDA has also issued the guidance document, "FDA's Recommended National Retail Food Regulatory Program Standards" as discussed in Annex 2, 3. Program Standard 3 addresses the regulatory program's use of HACCP principles at retail.

(A) Definitions

Many terms are used in discussion of HACCP that must be clearly understood to effectively develop and implement a plan. The following definitions are provided for clarity:

1. (1) Acceptable level means the presence of a hazard which does not pose the likelihood of causing an unacceptable health risk.
    
2. (2) Control point means any point in a specific food system at which loss of control does not lead to an unacceptable health risk.
    
3. (3) Critical control point, as defined in the Food Code, means a point at which loss of control may result in an unacceptable health risk.
    
4. (4) Critical limit, as defined in the Food Code, means the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to minimize the risk that the identified food safety hazard may occur.
    
5. (5) Deviation means failure to meet a required critical limit for a critical control point.
    
6. (6) HACCP plan, as defined in the Food Code, means a written document that delineates the formal procedures for following the HACCP principles developed by The National Advisory Committee on Microbiological Criteria for Foods.
    
7. (7) Hazard, as defined in the Food Code, means a biological, chemical, or physical property that may cause an unacceptable consumer health risk.
    
8. (8) Monitoring means a planned sequence of observations or measurements of critical limits designed to produce an accurate record and intended to ensure that the critical limit maintains product safety. Continuous monitoring means an uninterrupted record of data.
    
9. (9) Preventive measure means an action to exclude, destroy, eliminate, or reduce a hazard and prevent recontamination through effective means.
    
10. (10) Risk means an estimate of the likely occurrence of a hazard.
     
11. (11)  Sensitive ingredient means any ingredient historically associated with a known microbiological hazard that causes or contributes to production of a potentially hazardous food as defined in the Food Code.
     
12. (12)  Verification means methods, procedures, and tests used to determine if the HACCP system in use is in compliance with the HACCP plan.

(B) History

The application of HACCP to food production was pioneered by the Pillsbury Company with the cooperation and participation of the National Aeronautic and Space Administration (NASA), Natick Laboratories of the U.S. Army, and the U.S. Air Force Space Laboratory Project Group. Application of the system in the early 1960's created food for the United State's space program that approached 100% assurance against contamination by bacterial and viral pathogens, toxins, and chemical or physical hazards that could cause illness or injury to astronauts. HACCP replaced end-product testing to provide food safety assurance and provided a preventive system for producing safe food that had universal application.

In the succeeding years, the HACCP system has been recognized worldwide as an effective system of controls. The system has undergone considerable analysis, refinement, and testing and is widely accepted in the United States and internationally.

(C) Advantages of HACCP

FDA is recommending the implementation of HACCP in food establishments because it is a system of preventive controls that is the most effective and efficient way to ensure that food products are safe. A HACCP system will emphasize the industry's role in continuous problem solving and prevention rather than relying solely on periodic facility inspections by regulatory agencies.

HACCP offers two additional benefits over conventional inspection techniques. First, it clearly identifies the food establishment as the final party responsible for ensuring the safety of the food it produces. HACCP requires the food establishment to analyze its preparation methods in a rational, scientific manner in order to identify critical control points and to establish critical limits and monitoring procedures. A vital aspect of the establishment's responsibility is to establish and maintain records that document adherence to the critical limits that relate to the identified critical control points, thus resulting in continuous self-inspection. Secondly, a HACCP system allows the regulatory agency to more comprehensively determine an establishment's level of compliance. A food establishment's use of HACCP requires development of a plan to prepare safe food. This plan must be shared with the regulatory agency because it must have access to CCP monitoring records and other data necessary to verify that the HACCP plan is working. Using conventional inspection techniques, an agency can only determine conditions during the time of inspection which provide a "snapshot" of conditions at the moment of the inspection. However, by adopting a HACCP approach, both current and past conditions can be determined. When regulatory agencies review HACCP records, they have, in effect, a look back through time. Therefore, the regulatory agency can better ensure that processes are under control.

Traditional inspection is relatively resource-intensive and inefficient and is reactive rather than preventive compared to the HACCP approach for ensuring food safety. Regulatory agencies are challenged to find new approaches to food safety that enable them to become more focused and efficient and to minimize costs wherever possible. Thus, the advantages of HACCP-based inspections are becoming increasingly acknowledged by the regulatory community.

Examples of the successful implementation of HACCP by food establishments may be found throughout the food industry. During the past several years, FDA and a number of state and local jurisdictions have worked with two national voluntary pilot projects for retail food stores and restaurants. These projects involved more than 20 food establishments and demonstrated that HACCP is a viable and practical option to improve food safety. FDA believes that HACCP concepts have matured to the point at which they can be formally implemented for all food products on an industry-wide basis.

Continued to Part 2 . . . . .

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FDA