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

HACCP (Hazard Analysis and Cr itical 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 preventiv e 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 include din 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. and can be found at the web site http://vm.cfsan.fda.gov/~dms/hret-toc.html. 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 HAC CP 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:

(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 ea rly 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 accep ted 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 establish ment'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.

2. HACCP PRINCIPLES

(A) Background of NACMCF

Established in 1988, the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) is an advisory committee chartered under the U.S. Department of Agriculture (USDA) and comprised of participants from the USDA (Food Safety and Inspection Service), Department of Health and Human Services (U.S. Food and Drug Administration and the Centers for Disease Control and Prevention), the Department of Commerce (National Marine Fisheries Service), the Department of Defense (Office of the Army Surgeon General), academia, industry and state employees. NA CMCF provides guidance and recommendations to the Secretary of Agriculture and the Secretary of Health and Human Services regarding the microbiological safety of foods.

(B) Development of HACCP Principles

In November 1992, NACMCF defined seven widely accepted HACCP principles that were to be considered when developing a HACCP plan. In 1997, the NACMCF reconvened the HCCP Working Group to review the Committee's November 1992 HACCP document and to compare it to current HACCP guidance prepared by the CODEX Committee on Food Hygiene. From this committee, HACCP was defined as a systematic approach tot he identification, evaluatin and control of food safety hazards based on the following seven principles:

Principle 1: Conduct a hazard analysis.
Principle 2: Determine the critical control points (CCPs).
Principle 3: Establish critical limits.
Principle 4: Establish monitoring procedures.
Principle 5: Establish corrective actions.
Principle 6: Establish verification procedures.
Principle 7: Establish record-keeping and documentation procedures.

PRINCIPLE #1: HAZARD ANALYSIS

(a) Purposes

The hazard analysis process accomplishes three purposes:

Before beginning to develop a HACCP plan, a team should be assembled that is familiar with the overall food operation and the specific production processes to be included in the plan. The team's goal and each member's responsibilities in reaching that goal must be clearly defined.

The first step in the development of a HACCP plan for a food operation is identification of hazards associated with the product. A hazard may be a biological, chemical, or physical property that can cause a food to be unsafe. The analysis of hazards requires the assessment of two factors with respect to any identified hazard, i.e., the likelihood that the hazard will occur and the severity if it does occur. Hazard analysis also involves establishment of preventive measures for control. Hazards that involve low risk and that are not likely to occur need not be considered f or the purposes of HACCP.

To be effectively addressed, hazards must be such that their prevention, elimination, or reduction to acceptable levels is attained.

Numerous issues have to be considered during hazard analysis. These relate to factors such as ingredients, processing, distribution, and the intended use of the product. These issues include whether a food contains sensitive ingredients that can create microbiological, chemical, or physical hazards; or whether sanitation practices that are used can introduce these hazards to the food that is being prepared or processed. An example is whether the finished food will be heated by the consumer, if it is consumed off the premises. Even factors beyond the immediate control of the food establishment, such as how the food will be treated if taken out by the consumer and how it will be consumed, must be considered because these factors could influence how food should be prepared or processed in the establishment.

(b) Flow Diagram

Consequently, a flow diagram that delineates the steps in the process from receipt to sale or service forms the foundation for applying the seven principles. The significant hazards associated with each s tep in the flow diagram should be listed along with preventative measures proposed to control the hazards. This tabulation will be used under Principle 2 to determine the CCPs. The flow diagram should be constructed by a HACCP team that has knowledge and expertise on the product, process, and the likely hazards. Each step in a process should be identified and observed to accurately construct the flow diagram. Some examples of flow diagrams are found at the end of this Annex.

(c) Biological Hazards

Foodborne biological hazards include bacterial, viral, and parasitic organisms. These organisms are commonly associated with humans and with raw products entering the food establishment. Many of these pathogens occur naturally in the environment where foods are grown. Most are killed or inactivated by adequate cooking and numbers are kept to a minimum by adequate cooling during distribution and storage.

Bacterial pathogens comprise the majority of reported foodborne disease outbreaks and cases. A certain level of the pathogens can be expected with some raw foods. Temperature abuse, such as improper hot or cold holding temperatures, can significantly magnify this number. Cooked food which has been s ubject to cross-contamination with pathogens often provides a fertile medium for their rapid and progressive growth.

Enteric viruses can be foodborne, waterborne, or transmitted from a person or from animals. Unlike bacteria, a virus cannot multiply outside of a living cell. Hepatitis A and Norwalk viruses are examples of viral hazards associated with ready-to-eat foods.

Parasites are most often animal host-specific and can include humans in their life cycles. Parasitic infections are commonly associated with undercooking meat products or cross contamination of ready-to-eat food. Fishborne parasites in products that are intended to be eaten raw, marinated, or partially cooked can be killed by effective freezing techniques.

The following table provides an assessment of severity of the biological hazards which may be associated with food being prepared, served, or sold in food establishments.

TABLE 1. Hazardous Microorganisms and Parasites

Grouped on the Basis of Risk Severity^a

Severe Hazards

Clostridium botulinum types A, B, E, and F
Shigella dysenteriae
Salmonella Typhi; paratyphi A, B
Hepatitis A and E
Brucella abortus; B. suis
Vibrio cholerae 01
Vibrio vulnificus
Taenia solium
Trichinella spiralis

Moderate Hazards: Potentially Extensive Spread^b

Listeria monocytogenes
Salmonella spp.
Shigella spp.
Enterovirulent Escherichia coli (EEC)
Streptococcus pyogenes
Rotavirus
Norwalk virus group
Entamoeba histolytica
Diphyllobothrium latum
Ascaris lumbricoides
Cryptosporidium parvum

Moderate Hazards: Limited Spread

Bacillus cereus
Campylobacter jejuni
Clostridium perfringens
Staphylococcus aureus
Vibrio cholerae, non-01
Vibrio parahaemolyticus
Yersinia enterocolitica
Giardia lamblia< br> Taenia saginata

^a Adapted from International Commission on Microbiological Specifications for Food (ICMSF) (1986). Used with permission, "HACCP Principles and Applications", Pierson and Corlett, Eds. 1992. Chapman & Hall, New York, NY.

^b Although classified as moderate hazards, complications and sequelae may be severe in certain susceptible populations.

(d) Chemical Hazards

Chemical hazards in foods should be considered during a hazard analysis. Chemical contaminants may be naturally occurring or may be added during the processing of food. Harmful chemicals at very high levels have been associated with acute cases of foodborne illnesses and can be responsible for chronic illness at lower levels.

The following table provides some examples of chemical hazards found within the naturally occurring and added chemical categories. The Code of Federal Regulations, Title 21, provides guidance on naturally occurring toxic substances and allowable limits for many of the chemicals added during processing (food additives). The FDA Compliance Policy Guideli nes also provide information on other naturally occurring chemicals.

Table 2. Types of Chemical Hazards and Examples^a

Naturally Occurring Chemicals

Mycotoxins (e.g., aflatoxin) from mold
Scombrotoxin (histamine) from protein decomposition
Ciguatoxin from marine dinoflagellates
Toxic mushroom species
Shellfish toxins (from marine dinoflagellates)
Paralytic shellfish poisoning (PSP)
Diarrhetic shellfish poisoning (DSP)
Neurotoxic shellfish poisoning (NSP)
Amnesic shellfish poisoning (ASP)
Plant toxins
Pyrrolizidine alkaloids
Phytohemagglutinin

Added Chemicals

Agricultural chemicals:
Pesticides, fungicides, fertilizers, insecticides, antibiotics and growth hormones
Polychlorinated biphenyls (PCBs)
Industrial chemicals
Prohibited substances (21 CFR 189)
  Direct
  Indirect
Toxic elements and compounds:
  Lead, zinc, arsenic, mercu ry, and cyanide

^a Used with permission, "HACCP Principles and Applications", Pierson and Corlett, Eds. 1992. Chapman & Hall, New York, NY and adapted.

Food additives:

  Direct - allowable limits under GMPs
Preservatives (nitrite and sulfiting agents)
Flavor enhancers (monosodium glutamate)
Nutritional additives (niacin)
Color additives
Secondary direct and indirect
Chemicals used in establishments (e.g., lubricants, cleaners, sanitizers, cleaning compounds, coatings, and paints)
Poisonous or toxic chemicals intentionally added (sabotage)

(e) Food Allergens

Each year the Food & Drug Administration (FDA) receives reports of consumers who experienced adverse reactions following exposure to an allergenic substance in foods. Food allergies are abnormal responses of the immune system, especially involving the production of allergen-specific IgE antibodies, to naturally occurring proteins in certain foods that most individuals can eat safely. Frequently such reactions occur because the presence of th e allergenic substances in the foods is not declared on the food label.

To combat this problem, the agency issued a letter titled "Notice to Manufacturers," dated June 10, 1996, which addressed labeling issues and Good Manufacturing Practices (GMPs). This letter is available on FDA's website, www.cfsan.fda.gov/~lrd/allerg7.html.

FDA believes there is scientific consensus that the following foods can cause serious allergic reactions in some individuals and account for more than 90% of all food allergies.

Current FDA policy, as reflected in FDA Compliance Policy Guide (CPG) 555.250 with regard to direct addition as ingredients or sub-ingredients, is:

Products which contain an allergenic ingredient by design must comply with 21 U.S.C. 343(i)(2). Where substances that are, bear, or contain allergens are added as ingredients or sub-ingredients (including rework), the Feder al Food, Drug, and Cosmetic Act (the Act) requires a complete listing of the food ingredients (section 403(i)(2); 21 U.S.C. 343(i)(2); 21 C.F.R.101.4) unless a labeling exemption applies.

FDA's Regulations (21 CFR 101.100(a)(3)), provide that incidental additives, such as processing aids, which are present in a food at insignificant levels and that do not have a technical or functional effect in the finished food are exempt from ingredient declaration. Some manufacturers have asserted to FDA that some allergens used as processing aids qualify for this exemption. FDA, however, does not consider food allergens eligible for this exemption. Evidence indicates that some food allergens can cause serious reactions in sensitive individuals upon ingestion of very small amounts; therefore, the presence of an allergen must be declared in accordance with 21 CFR 101.4.

Allergens may be unintentionally added to food as a result of practices such as improper rework addition, product carry-over due to use of common equipment and production sequencing, or the presence of an allergenic product above exposed product lines. Such practices with respect to allergenic substances can be insanitary conditions that may render the food injurious to health and adulterate the product under section 402(a)(4) of the Act [21 U.S.C. 342(a)(4)|.

(f) Physical Hazards

Illness and injury can result from hard foreign objects in food. These physical hazards can result from contamination and/or poor procedures at many points in the food chain from harvest to consumer, including those within the food establishment.

As establishments develop their HACCP programs, the following table can be used to further identify sources of potential physical risks to the food being prepared, served, or sold.

(f) Determining Level of Risk

The potential significance or risk of each hazard should be assessed by considering its likelihood of occurrence and severity. The estimate of risk for a hazard occurring is based upon a combination of experience, epidemiological data, and information in the technical literature. Severity is the degree of seriousness of the consequences of a hazard if it were to become an actuality.

Hazard identification in conjunction with risk estimation provides a rational basis for determining which hazards are significant and must be addressed in the HACCP plan. To determine risk during the hazard analysis, safety concerns must be differentiated from quality concerns. A food safety hazard is a biological, chemical, or physical property that may cause a food to be unsafe. There may be differences of opinion, even among experts, as to the risk of a hazard. The food establishment must rely upon the expert opinion published in peer reviewed literature or experts who actively assist in the development of the HACCP plan.

The hazards m ust at least include those that are commonly associated with a specific product. If a hazard that is commonly associated is dismissed from the plan, the basis for rejecting it must be clearly stated in the hazard analysis so that it is understood and agreed to by the regulatory authority reviewing the HACCP plan.

(g) Hazard Analysis Process

This point in hazard analysis consists of asking a series of questions which are appropriate to each step in the flow diagram. The hazard analysis should question the effect of a variety of factors upon the safety of the food.

(h) Developing Preventive Measures

The preventive measures procedure identifies the steps in the process at which hazards can be controlled.

After identifying the hazards the food establishment must then consider what preventive measures, if any, can be applied for each hazard. Preventive measures are physical, chemical, or other factors that ca n be used to control an identified health hazard. More than one preventive measure may be required to control a specific hazard and more than one hazard may be controlled by a specified preventive measure.

For example, if a HACCP team were to conduct a hazard analysis for the preparation of hamburgers from frozen beef patties, enteric pathogens on the incoming raw meat would be identified as a potential hazard. Cooking is a preventive measure which can be used to eliminate this hazard. Thus, cooking, the preventive mea sure, would be listed along with the hazard (i.e., enteric pathogens) as follows:

PRINCIPLE #2: IDENTIFY THE CRITICAL CONTROL POINTS (CCP) IN FOOD PREPARATION

A CCP is a point, step, or procedure at which control can be applied and a food safety hazard can be prevented, eliminated, or reduced to acceptable levels. Points in food preparation that may be CCPs include cooking, chilling, specific sanitation procedures, product formulation control, prevention of cross contamination, and certain aspects of employee and environmental hygiene. For example, cooking that must occur at a specific temperature and for a specified time in order to destroy microbiological pathogens is a critical control point. Likewise, refrigeration or the adjustment of a food's pH to a level required to prevent hazardous microorganisms from multiplying or toxins from forming are also CCPs.

Many points in food preparation may be considered control points, but very few are actually critical control points. A control point is any point, step, or procedure at which biological, physical, or chemical factors can be controlled. Concerns that do not impact food safety may be addressed at control points; however, since these control points do not relate to food safety, they are not included in the HACCP plan.

Different facilities preparing the same food can differ in the risk of hazards and the points, steps, or procedures which are CCPs. This can be due to differences in each facility such as layout, equipment, selection of ingredients, or the process that is used. Generic HACCP plans can serve as useful guides; however, it is essential that the unique conditions within each facility be considered during the development of a HACCP plan.

CCPs must be carefully developed and documented. In addition, they must be used only for purposes of product safety. The following decision tree is helpful in verifying which of the food preparation steps should be designated as CCPs.

PRINCIPLE #3: ESTABLISH CRITICAL LIMITS FOR PREVENTIVE MEASURES

Associated with Each Identified Critical Control Point

This step involves establishing a criterion that must be met for each preventive measure associated with a CCP. Critical limits can be thought of as boundaries of safety for each CCP and may be set for preventive measures such as temperature, time, physical dimensions, a_w, pH, and available chlorine. Critical limits may be derived from sources such as regulatory standards and guidelines, scientific literature, experimental studies, and consultation with experts.

(a) Critical Limit

A critical limit is defined as a criterion that must be met for each preventive measure associated with a CCP. Each CCP will have one or more preventive measures that must be properly controlled to ensure prevention, elimination, or reduction of hazards to acceptable levels. The food establishment is responsible for using competent authorities to validate that the critical limits chosen will control the identified hazard.

(b) Target Level

In some cases, variables involved in food preparation may require certain target levels to ensure that critical limits are not exceeded. For example, a preventive measure and critical limit may be an internal product temperature of 71?C (160?F) during one stage of a process. The oven temperature, however, may be 71 ?3?C (160??F); thus an oven target temperature would have to be greater than 74?C (165?F) so that no product receives a cook of less than 71?C (160?F).

(c) Application Example

An example for Principle 3 is the cooking of beef patties. The process should be designed to eliminate the most heat-resistant vegetative pathogen which could reasonably be expected to be in the product. Criteria may be required for factors such as temperature, time, and meat patty thickness. Technical development of the appropriate critical limits requires accurate information on the probable maximum numbers of these microorganisms in the meat and their heat resistance. The relationship between the CCP and its critical limits for the meat patty example is shown below:

PRINCIPLE #4: ESTABLISH PROCEDURES TO MONITOR CCPS

PRINCIPLE #5: ESTABLISH THE CORRECTIVE ACTION TO BE TAKEN WHEN MONITORING SHOWS THAT A CRITICAL LIMIT HAD BEEN EXCEEDED

PRINCIPLE #6: ESTABLISH PROCEDURES TO VERIFY THAT THE HACCP SYSTEM IS WORKING

HACCP PRINCIPLE #7: ESTABLISH EFFECTIVE RECORD KEEPING SYSTEMS THAT DOCUMENT THE HACCP SYSTEM

The following chart is an example of a HACCP plan documentation for a product cooling step in a retail level food establishment.

3. SUMMARY

HACCP is a systematic approach to food safety which will dramatically improve the level of food safety. The NACMCF has developed the seven HACCP principles discussed within this Annex. The FDA recommends the implementation of a HACCP system throughout the food industry using these NACMCF recommendations.

An effective national food safety program from food production to consumer is enhanced by the implementation of HACCP. The statistics from foodborne surveillance reveal that retail level food establishments can have a significant impact on the health of consumers.

Implementation of HACCP programs by the establishments will profoundly enhance their role in the protection of public health beyond the traditional emphasis on facility and equipment design and maintenance and adherence to the principles of sanitation, good manufacturing, and food preparation practices. The education and training of all personnel are critical to the success and effectiveness of any HACCP program. The Food Code stresses the application to HACCP principles and the knowledge and responsibilities of establishment management and employees.

Specific HACCP plans for the products prepared and sold by the retail food establishment should be developed and implemented for optimal food safety management. HACCP systems are recommended for use as a tool for regulatory inspections. The regulatory official should incorporate procedures in the inspection process that ensure record reviews and active monitoring.

Because the retail food establishment industry is composed of large, small, chain, and independent establishments, the level of food safety expertise varies widely and is not necessarily linked to size or affiliation. Regardless of the size and sophistication of the establishment, a HACCP plan for safe food preparation and sales needs to be designed, implemented, and verified.

Studies have shown that a significant level of illness and mortality from foodborne disease in institutional feeding operations such as hospitals, nursing homes, and prisons is related to preventable causes. For populations that may be more vulnerable to foodborne disease, FDA and the NACMCF recommend that HACCP systems be immediately implemented by establishments and institutions preparing foods for these susceptible individuals.

Food p rocessing operations at retail food establishments such as reduced oxygen packaging and curing and smoking under the Food Code are required to develop and implement a HACCP plan for that part of the operation. Additionally, any establishment seeking a variance from the requirements of the Code must submit a HACCP plan. The HACCP Annex can serve to guide these establishments in this process.

Food establishments have the primary responsibility for food safety. The development and implementation of HACCP programs is a reliable and responsible step to help ensure the safety of food offered for consumption.

4. ACKNOWLEDGMENTS

Much of this HACCP Annex material is adapted from National Advisory Committee on Microbiological Criteria for Foods, Hazard Analysis and Critical Control Point System, adopted March 20, 1992.

Some of the charts were provided courtesy of "Overview of Biological, Chemical, and Physical Hazards" in "HACCP Principles and Applications, Merle Pierson and Donald A. Corlett, Jr. (Eds.), 1992 p 8-28. Chapman and Hall, New York.

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