DRAFT
SECTION 1: The Retail Food Safety Need
  • Introduction
  • Hazard Classification
  • The Process of Hazard Identification
  • Food-related Illness and Death in the United States
  • Government Microbiological Standards for Raw and Pasteurized Food
  • Need for International Safe and Hazardous Level Guidelines

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    Introduction
            As more retail food operations across the U.S. and throughout the world compete to feed consumers, it becomes essential that uniform hazard analysis and control guidelines for producing, buying, and selling food products be developed.  These guidelines must be based on science and validated in actual operation.  At this time, consumers in the U.S. are doing less food preparation themselves and are dining out and/or are relying on retail food outlets for ready-prepared items.  Food operations, as defined in this document, include:  food markets where food is sold to be prepared in the home; food preparation and foodservice establishments that include restaurants, institutional foodservice units, street vending operations, hotel and lodging operations, military commissaries; and even the home, which is actually a miniature foodservice unit.
            Food science and technology have improved the understanding of the potential microbiological, chemical, and physical hazards in foods.  This knowledge can be used to determine the criteria necessary to assure that food products and commodities meet consumer safety expectations with an acceptable risk at the raw material level, the distributor level, and the consumer level.  International trade and tourism will be enhanced throughout the world when there is a clearer understanding between the producer, retailer/supplier, and the buyer of food concerning the potential hazards in food and the level of risk associated with consuming a food.
           Beginning with Codex Alimentarius (32) and the International Commission on Microbiological Specifications for Food (ICMSF), and continuing with the National Advisory Committee on Microbiological Criteria for Foods (135), there has been a movement for many years for more complete safety specifications for foods in local, national and international trade.  The result is the current emphasis on Hazard Analysis and Critical Control Points (HACCP) in food production facilities and retail food operations.  However, people have lost sight of the fact that HACCP is only a part of a company's food production quality management program.  A company cannot accomplish process hazard control until it has process quality control.  Hazards and critical control points can be easily identified.  However, it is a separate issue to actually operate so that there is a very low chance of process deviation and low risk of a hazardous item being produced.

    Hazard Classification
            The World Health Organization (WHO) Division of Food and Nutrition (200) identifies a hazard as a biological, chemical, or physical agent or condition in food with the potential to cause harm.  In addition to these factors, nutrient levels inadequate to prevent deficiency disease must also be considered as a hazard.  Note that one food, or even a single serving, while it could cause foodborne illness, no retail dish or retailer (except in institutions) is responsible for balancing the client's entire diet.
            Actually, food is never risk free.  The Environmental Protection Agency (EPA) has developed many risk criteria for water and chemicals.  Unfortunately, the consumer's standard for purchased food is zero risk, which is unattainable.  There will never be totally pathogen-free food animals or fruits and vegetables, nor will there ever be human populations who excrete totally pathogen-free fecal material.  Therefore, hazards must be assessed, and risks must be reduced to a safe level.
            Hazard analysis is the process of collecting and interpreting information to assess the risk and severity of potential hazards (ICMSF, 90).  It is appropriate to classify hazards as critical concern, major concern, and minor concern.  The definitions for hazards in food are as follows:

    Critical Concern:  without control, there is life-threatening risk.
    Major Concern:  a threat that must be controlled but is not life threatening and requires no government intervention.
    Minor Concern:  no threat to the consumer (normally quality and cleanliness issues).

            For example, spoilage bacteria, even at more than 50,000,000 per gram, are of no known safety concern.  Coliform bacteria include both spoilage and pathogenic microorganisms.  Therefore, a coliform count of 1,000 CFU per gram is of minor concern until specified levels of specific pathogens in the coliform group are established.  Only pathogens and pathogenic substances ingested above threshold levels can cause illness, disease, and death.  Properly controlled levels of salt, sugar, and MSG are of no concern.  Floors, walls, ceilings, and many other items grouped under Good Manufacturing Practices (31) are really minor concern.
            Of minor concern is also the presence of 1,000 Staphylococcus aureus cells, Bacillus cereus spores, or Clostridium perfringens spores per gram of food.  These organisms are not hazardous until they reach 100,000 vegetative cells per gram.  A hazard of critical concern, on the other hand, is a dose of 1 or more Escherichia coli O157:H7, 100 Salmonella spp., or 500 Campylobacter jejuni in a portion of hamburger or chicken.  It is essential that food be prepared by a cook who is trained to reduce potential hazards to a safe level.  Even healthy people can become ill if they consume food containing these pathogens at high enough levels.
            Some people develop natural immunity.  People who live in an environment with greater levels of pathogenic agents have a greater tolerance. The example is farmers who acquire a natural immunity and elevated resistance to some illnesses after being exposed to many of these pathogens while working on their farms.  It is the job of the cook to make food safe by washing the food, such as raw fruits and vegetables and by pasteurizing raw food with the application of heat.  During preparation, care must be taken to prevent cross-contamination of any ready-to-eat foods when raw foods are handled. (Raw foods include fruits and vegetables as well as meat, fish, and poultry products.)

    The Process of Hazard Identification
            In order to develop a process or operation capable of protecting public health, which, in turn, will minimize liability costs, it is essential that a logical process for hazard identification be followed.  The following criteria should be included in the hazard analysis:
     
    1. Evidence that the microbial, chemical, or physical agent is a hazard to health based on epidemiological data or a laboratory hazard analysis.
    2. The type and kind of the natural and commonly acquired microflora of the ingredient or food, and the ability of the food to support microbial growth.
    3. The effect of processing on the microflora of the food.
    4. The potential for microbial contamination (or recontamination) and/or growth during processing, handling, storage, and distribution.
    5. The types of consumers at risk.
    6. The state in which food is distributed (e.g., frozen, refrigerated, heat processed, etc.).
    7. Potential for abuse at the consumer level.
    8. The existence of Good Manufacturing Practices (GMPs).
    9. The manner in which the food is prepared for ultimate consumption (i.e., heated or not).
    10. Reliability of methods available to detect and/or quantify the microorganism(s) and toxin(s) of concern.
    11. The costs / benefits associated with the application of items 1 through 10 (as listed above).
            Coupling hazard analysis with correct hazard control and operating procedures enables the retail food operator to demonstrate a high degree of "due diligence" in the prevention of problems.   Due diligence is essential if an operator is to avoid punitive legal damages resulting from a lawsuit because he/she did nothing to control the hazards in the food.

    Food-related Illness and Death in the United States
            While cooks can control most pathogenic agents in food most of the time, there are still an enormous number of illnesses and deaths that occur each year in the U. S because of foodborne agents.  More than 200 known diseases are transmitted through food [Bryan (202); Mead et al. (203)].  The causes of foodborne illness and disease include viruses, bacteria, parasites, toxins, metals, and prions, and the symptoms of foodborne illness vary from mild gastroenteritis to life-threatening neurologic, hepatic, and renal disorders.

    Table 1-1

            A 1999 Centers for Disease Control and Prevention report (203) estimated cases of illness and deaths for the general population in the U.S. due to known causes.  (See Table 1-1.)
            By examining Table 1-1, it can be seen that not all of these pasthogens are transferred by food.  They are sometimes spread by water, person-to-person contact, or  other means.  Also note that 67% of the estimated 13.8 million foodborne illnesses of known etiology are viral (Norwalk-like viruses).
            The authors of the 1999 CDC report (203) applied another analysis, taking into account under-reporting factors, to arrive at an estimate that predicts a much larger annual illness incidence of 76 million (mostly diarrheal illnesses of 1-to-2-day duration), 325,000 hospitalizations, and 5,000 deaths.  This estimate is based on the authors' further speculation that 80% of the illnesses that occur annually are due to "unidentified etiological agents".
            The CDC report (203) did not estimate causes of illness or injury due to chemicals, toxins, or hard foreign objects in food.  Predicted annual occurrences cited in Table 1-2 are those estimated by Todd (186).

      Table 1-2
            The pathogens responsible for foodborne illness and disease are ubiquitous.  Because of environmental and animal contamination, food and food products will always be contaminated with low levels of pathogens, and occasionally at high levels (especially poultry).  At low levels, pathogenic microorganisms in food cause no problems, and people even develop immunity to their presence in food (74, 85, 91, 137, 151, 181, 198).  At illness thresholds, however, pathogens in food can make people ill and cause death.  Pathogens in food can only be controlled when food producers, food retailers, and consumers know the potential hazards in food, and handle and prepare food by methods to reduce the hazard to a tolerable level.
            How do pathogens in food get to high levels?  It can happen anywhere in the food chain, from growing the animal, fish, vegetable or fruit to consumption.  Everyone in the food chain must have knowledge of the causes of foodborne disease and illness, and must establish a program that assures safety before they produce and sell food.  If not, incomplete hazard control processes are implemented.

    Government Microbiological Standards for Raw and Pasteurized Food
            The Code of Federal Regulations [9 CFR §301.2 C] (30) has been interpreted by the United States Department of Agriculture and the Food and Drug Administration to mean that if a sample of a processed food is found to be contaminated with E. coli O157:H7, Salmonella spp., or Listeria monocytogenes, the food is deemed unfit for human consumption.  Sample size is variable, often negative in 25 grams, but the products' microbial standard is not enforced in retail operations, because retail inspectors seldom check.  In retail food operations, the presence of L. monocytogenes is likely on fresh produce, meat, fish, and poultry, as well as on floors and in floor drains.  It has been estimated by Farber (48) that raw food (e.g., coleslaw) can contain 100 to 10,000 CFU/g of L. monocytogenes.  Meat products will have low levels of E. coli O157:H7 and Salmonella spp., and poultry is often found to be contaminated with Campylobacter jejuni and Salmonella spp.

    Need for International Safe and Hazardous Level Guidelines
            At the present time, there are few worldwide food safety guidelines for upper or lower control limits of potential hazards in foods, or the process limits.  This document proposes limits.  When standards do exist, they may be inappropriate (e.g., specification of the numbers of coliforms in milk and in shellfish waters), or they may be unattainable (e.g., a zero level of both Salmonella spp. and L. monocytogenes in food).  There is no zero level in food safety.  There is a point at which measurements cannot be made with any degree of statistical reliability, and this point is frequently taken as "zero."  For example, processed food is assumed to be safe from salmonellae contamination if there are no detectable salmonellae in a sample using the method of analysis described by the Bacteriological Analytical Manual (54).  However, as laboratory methods improve, standards for safe levels of pathogenic material in food may be established.  When safety standards or guidelines are developed for microbiological, chemical, and physical hazards in food, the standards or guidelines must be based on the risk of causing injury or illness to consumers, not what the processing industry is capable of achieving, or what scientific technology is capable of measuring.
     

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