Foodborne Illness Risk Factors

Foodborne Illness Risk Factors & Public Health Interventions

PUBLIC HEALTH SIGNIFICANCE AND REASONS FOR CONTROL AND IMPLEMENTATION

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F001 - PERSON IN CHARGE PRESENT, EMPLOYEES TRAINED, DEMONSTRATES KNOWLEDGE F002 - MANAGEMENT, RESPONSIBILITY, REPORTING F003 - PROPER USE OF EXCLUSION AND RESTRICTION OF ILL FOOD WORKERS F004 – PROPER EATING, DRINKING, TASTING, TOBACCO USE F005 - NO BARE HAND CONTACT WITH READY-TO-EAT FOODS F006 - PROPER HANDWASHING F007 - FOOD OBTAINED FROM APPROVED SOURCE F008 - FOOD RECEIVED AT PROPER TEMPERATURES F009 - FOOD IN GOOD CONDITION, SAFE, UNADULTERATED F010 - REQUIRED RECORDS AVAILABLE - SHELLFISH TAGS, PARASITE DESTRUCTION F011 - FOOD SEPARATED AND PROTECTED F012 - FOOD CONTACT SURFACES - CLEANED AND SANITIZED F013 - PROPER DISPOSITION OF RETURNED, PREVIOUSLY SERVED AND UNSAFE FOOD F014 - PROPER COOKING TIME AND TEMPERATURES, STEM THERMOMETER AVAILABLE AND USED F015 - PROPER REHEATING PROCEDURES FOR HOT HOLDING F016 - PROPER COOLING TIME AND TEMPERATURES F017 - PROPER HOT AND COLD HOLDING TEMPERATURES F018 - PROPER DATE MARKING PROCEDURES USED F019 - TIME AS A PUBLIC HEALTH CONTROL - PROCEDURES AND RECORDS F020 - CONSUMER ADVISORY PROVIDED FOR RAW AND UNDERCOOKED FOODS F021 - PASTEURIZED FOODS USED, PROHIBITED FOODS NOT OFFERED F022 - FOOD ADDITIVES - APPROVED AND PROPERLY USED F023 - CHEMICALS AND TOXIC MATERIALS STORED AND USED PROPERLY F024 - PERSONAL MEDICATIONS PROPERLY STORED F025 - COMPLIANCE WITH VARIANCE PROCEDURES F026 - RUNNING WATER PROVIDED WHERE REQUIRED F027 - SEWAGE AND WASTEWATER PROPERLY DISPOSED F028 - WATER AND ICE FROM APPROVED SOURCES

SUPERVISION

F001 - PERSON IN CHARGE PRESENT, EMPLOYEES TRAINED, DEMONSTRATES KNOWLEDGE

760-1340.6 Designation of a person in charge during all hours of operations ensures the continuous presence of someone who is responsible for monitoring and managing all food establishment operations and who is authorized to take actions to ensure that the sanitary code's objectives are fulfilled. During the day-to-day operation of a food establishment, a person who is immediately available and knowledgeable in both operational and sanitary code requirements is needed to respond to questions and concerns and to resolve problems. Scientific studies have shown that food establishments in which a food manager/food safety certificate holder is present are less likely to have foodborne illness outbreaks.

760-1340.11 The designated person in charge who is knowledgeable about foodborne disease prevention, Hazard Analysis and Critical Control Point (HACCP) principles, and sanitary code requirements is prepared to recognize conditions that may contribute to foodborne illness or that otherwise fail to comply with sanitary code requirements, and to take appropriate preventive and corrective actions.

There are many ways in which the person in charge can demonstrate competency. Many aspects of the food operation itself will reflect the competency of that person. A dialogue with the person in charge during the inspection process will also reveal whether or not that person is enabled by a clear understanding of the sanitary code and its public health principles to follow sound food safety practices and to produce foods that are safe, wholesome, unadulterated, and accurately represented.

760-1340.15 A primary responsibility of the person in charge is to ensure compliance with sanitary code requirements. Any individual present in areas of a food establishment where food and food-contact items are exposed presents a potential contamination risk. By controlling who is allowed in those areas and when visits are scheduled and by assuring that all authorized persons in the establishment, such as delivery, maintenance and service personnel, and pest control operators, comply with sanitary code requirements, the person in charge establishes an important barrier to food contamination.

Food allergy is an increasing food safety and public health issue, affecting approximately 4% of the U.S. population, or twelve million Americans. Restaurant and retail food service managers need to be aware of the serious nature of food allergies, including allergic reactions, anaphylaxis, and death; to know the eight major food allergens; to understand food allergen ingredient identities and labeling; and to avoid cross-contact during food preparation and service. The person in charge’s duties include ensuring that the food safety training of employees includes food allergy awareness in order for them to safely perform duties related to food allergies.

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EMPLOYEE HEALTH

F002 - MANAGEMENT, RESPONSIBILITY, REPORTING

760-1340.1 Proper management of a food establishment operation begins with employing healthy people and instituting a system of identifying employees who present a risk of transmitting foodborne pathogens to food or to other employees. The person in charge is responsible for ensuring all food employees are knowledgeable and understand their responsibility to report listed symptoms, diagnosis with an illness from a listed pathogen, or exposure to a listed pathogen to the person in charge. The person in charge is also responsible for reporting to the Department if a food employee reports a diagnosis with a listed pathogen. This reporting requirement is an important component of any food safety program. A food employee who suffers from any of the illnesses or medical symptoms or has a history of exposure to a listed pathogen in the sanitary code may transmit disease through the food being prepared. The person in charge must first be aware that a food employee is suffering from a disease or symptom listed in the sanitary code before steps can be taken to reduce the chance of foodborne illness.

The person in charge may observe some of the symptoms that must be reported. However, food employees share a responsibility for preventing foodborne illness and are obligated to inform the person in charge if they are suffering from any of the listed symptoms, have a history of exposure to one of the listed pathogens, or have been diagnosed with an illness caused by a listed pathogen. Food employees must comply with restrictions or exclusions imposed upon them (as specified in Appendix F of the sanitary code). When a symptomatic or diagnosed food employee has met the criteria for reinstatement the food employee may then return to work as a food employee.

760-1340.2 The purpose of this section of the sanitary code is to reduce the likelihood that certain viral and bacterial agents will be transmitted from infected food workers into food. The agents of concern are known to be readily transmissible via food that has been contaminated by ill food workers, and so for that reason, are the primary focus of this section of the sanitary code. However, there are different levels of risk associated with different levels of clinical illness. The structure of the restrictions and exclusions has, therefore, been designed in a tiered fashion depending on the clinical situation to offer the maximum protection to public health with the minimal disruption to employees and employers.

Four levels of illness or potential illness have been identified with the first level being the highest potential risk to public health and the fourth level being the lowest. The first level relates to employees who have specific symptoms (e.g., vomiting, diarrhea, jaundice) while in the workplace. These symptoms are known to be associated commonly with the agents most likely to be transmitted from infected food workers through contamination of food. The first level also relates to employees who have been diagnosed with typhoid fever or an infection with Hepatitis A virus (within 14 days of symptoms). The second level relates to employees who have been diagnosed with the specific agents that are of concern, but who are not exhibiting symptoms of disease because their symptoms have resolved. The third level relates to employees who are diagnosed with the specific agents, but never develop any gastrointestinal symptoms. The fourth level relates to those individuals who are clinically well but who may have been exposed to a listed pathogen and are within the normal incubation period of disease.

The most significant degree of restriction and exclusion applies to the first level of food employee illness. Infected food employees in the first level are likely to be excreting high levels of their infectious pathogen, increasing the chance of transmission to food products, and thus on to those consuming the food. The first level includes food employees who are:

Experiencing active symptoms of diarrhea or vomiting – with no diagnosis,
Experiencing jaundice within the last 7 days-- with no diagnosis,
Diagnosed with typhoid fever,
Diagnosed with Hepatitis A within 7 days of jaundice or 14 days of any symptoms, or
Experiencing active symptoms of diarrhea or vomiting, and diagnosed with Norovirus, E. coli O157:H7 or other Enterohemorrhagic Escherichia coli (EHEC) or Shiga toxin-producing Escherichia coli (STEC), or Shigella spp. infection.

Diagnosis with typhoid fever or Hepatitis A virus is included in level 1 because employees diagnosed with these pathogens are likely to be shedding high levels of the pathogen in their stool without exhibiting gastrointestinal symptoms. Peak levels of Hepatitis A viral shedding in the feces typically occurs before symptoms appear. Diarrhea and vomiting are reliable indicators of infection with Norovirus, E. coli O157:H7 or other EHEC, and Shigella spp., but are not typical symptoms of typhoid fever or Hepatitis A. For example, employees diagnosed with typhoid fever are more likely to experience constipation, rather than diarrhea. Jaundice is also not always reliable as an indicator of a Hepatitis A infection because employees can be infected with Hepatitis A virus without experiencing jaundice (anicteric employees).

Maximum protection to public health requires excluding food employees suffering from typhoid fever, Hepatitis A virus, or specific gastrointestinal symptoms associated with diseases identified as likely to be transmitted through contamination of food. This situation describes the highest level of risk in transmitting pathogens to food, or what we would find in the first level.

Food employees who have been diagnosed with one of the agents of concern, but are not symptomatic because their symptoms have resolved, are still likely to be carrying the infected agent in their intestinal tract. This makes such employees less likely to spread the agent into food than others who are actually symptomatic, but employees diagnosed with one of the agents of concern still pose an elevated threat to public health. For this reason, there are a series of exclusions depending on the agent involved. This situation describes the second level of risk in transmitting pathogens to food.

Diagnosed, asymptomatic food employees who never develop symptoms are typically identified during a foodborne illness outbreak investigation through microbiological testing. If infected and asymptomatic employees are not microbiologically tested, they will remain undetected and could therefore extend the duration of a foodborne illness outbreak through continued contamination of food. The sanitary code provides restriction or exclusion guidelines for employees that are identified through microbiological testing with an infection from a listed foodborne pathogen, but are otherwise asymptomatic and clinically well. The exclusion or restriction guidelines are applied until the identified food employees no longer present a risk for foodborne pathogen transmission. This situation describes the third level of risk in transmitting pathogens to food.

Some food employees may report a possible exposure to an agent. For example, a food employee may have attended a function at which the food employee ate food that was associated with an outbreak of shigellosis, but the employee remains well. Such individuals fall into the category of having had a potential exposure and present a lower risk to public health than someone who is either symptomatic or who has a definitive diagnosis. They present a level of risk to public health that is greater than if they had not had the exposure. The approach taken in the sanitary code to food employees who have had a potential exposure is based on the incubation times (time between exposure and the onset of symptoms) of the various agents. The times chosen for restriction are the upper end of the average incubation periods for the specific agents. The reasoning is that this will restrict food employees only up to the time when it is unlikely they will develop symptoms. As a further protection to public health, it is recommended that such exposed food employees pay particular attention to personal hygiene and report the onset of any symptoms. This situation describes the fourth level of risk in transmitting pathogens to food.

This structured approach has linked the degree of exclusion and restriction to the degree of risk that an infected food worker will transmit an agent of concern into food. The approach strikes a balance between protecting public health and the needs of the food employee and employer.

The sanitary code provisions related to employee health are aimed at removing highly infectious food employees from the work place. They were developed with recognition of the characteristics of the five important pathogens, and of the risk of disease transmission associated with symptomatic and asymptomatic shedders.

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F003 - PROPER USE OF EXCLUSION AND RESTRICTION OF ILL FOOD WORKERS

760-1340.5 It is necessary to exclude food employees symptomatic with diarrhea, vomiting, or jaundice, or suffering from a disease likely to be transmitted through contamination of food, because of the increased risk that the food being prepared will be contaminated such as with a pathogenic microorganism. However, if the food employee is suffering from vomiting or diarrhea symptoms, and the condition is from a non-infectious condition, Crohn’s disease or an illness during early stages of a pregnancy, the risk of transmitting a pathogenic microorganism is minimal. In this case, the food employee may remain working in a full capacity if they can substantiate that the symptom is from a noninfectious condition. The food employee can substantiate this by providing to the Department and person in charge medical documentation or other documentation proving that the symptom is from a noninfectious condition.

Because of the high infectivity (ability to invade and multiply) and/or virulence (ability to produce severe disease), of typhoid fever (Salmonella Typhi) and Hepatitis A virus, a food employee diagnosed with an active case of illness caused by either of these two pathogens, whether asymptomatic or symptomatic, must be excluded from food establishments. The exclusion is based on the high infectivity, and/or the severe medical consequences to individuals infected with these organisms. A food employee diagnosed with an active case of illness caused by Norovirus, Shigella spp., or E. coli O157:H7 or other EHEC/STEC, is excluded if exhibiting symptoms of vomiting and diarrhea, and then allowed to work as the level of risk of pathogen transmission decreases the degree of risk for a food employee who is diagnosed with an infection but asymptomatic with regard to symptoms, to transmit a foodborne pathogen decreases with the resolution of symptoms. This risk decreases even further for those employees that are diagnosed with a listed pathogen, but never developed symptoms. The decrease in risk is taken under consideration when excluding and restricting diagnosed food employees and results in a slight difference in the way food employees diagnosed with Norovirus, but asymptomatic with respect to gastrointestinal symptoms are handled.

Periodic testing of food employees for the presence of diseases transmissible through food is not cost effective or reliable. Therefore, restriction and exclusion provisions are triggered by the active gastrointestinal symptoms, followed by diagnosis and history of exposure.

The history of exposure that must be reported applies only to the 5 organisms listed.

Upon being notified of the history of exposure, the person in charge should immediately:

Discuss the traditional modes of transmission of fecal-oral route pathogens.
Advise the food employee to observe good hygienic practices both at home and at work. This includes a discussion of proper handwashing, as described in the sanitary code, after going to the bathroom, changing diapers, or handling stool-soiled material.
Review the symptoms listed in the sanitary code that require immediate exclusion from the food establishment.
Remind food employees of their responsibility as specified in the sanitary code to inform the person in charge immediately upon the onset of any of the symptoms listed in the sanitary code.
Ensure that the food employee stops work immediately and report to the person in charge if any of the symptoms described in the sanitary code develop.

A restricted food employee may work in an area of the food establishment that houses packaged food, wrapped single-service or single-use articles, or soiled food equipment or utensils. Examples of activities that a restricted person might do include working at the cash register, seating patrons, bussing tables, stocking canned or other packaged foods, or working in a non-food cleaning or maintenance capacity consistent with the criteria in the definition of the term “restricted.” A food employee who is restricted from working in one food establishment may not work in an unrestricted capacity in another food establishment, but could work unrestricted in another retail store that is not a food establishment. A restricted food employee may enter a food establishment as a consumer.

An excluded individual may not work as a food employee on the premises of any food establishment.

Food employees diagnosed with Norovirus, Hepatitis A virus, Shigella spp., E. coli O157:H7 or other EHEC, and symptomatic with diarrhea, vomiting, or jaundice, are excluded. Diagnosis with a listed pathogen invokes additional requirements as stated in Part 2.50 of the New York State sanitary code before the person in charge may allow diagnosed food employees to return to work in full capacity.

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GOOD HYGIENIC PRACTICES

F004 – PROPER EATING, DRINKING, TASTING, TOBACCO USE

760-1341.1.g Proper hygienic practices must be followed by food employees in performing assigned duties to ensure the safety of the food, prevent the introduction of foreign objects into the food, and minimize the possibility of transmitting disease through food. Smoking by employees in food preparation areas is prohibited because of the potential that the hands, food, and food-contact surfaces may become contaminated, and employees could introduce pathogens to food by hand-to-mouth-to-food contact. Poor hygienic practices by employees may also adversely affect consumer confidence in the establishment.

760-1341.1.h Proper hygienic practices must be followed by food employees in performing assigned duties to ensure the safety of the food, prevent the introduction of foreign objects into the food, and minimize the possibility of transmitting disease through food. Eating by employees in food preparation areas is prohibited because of the potential that the hands, food, and food-contact surfaces may become contaminated. Food preparation areas such as hot grills may have elevated temperatures and the excessive heat in these areas may present a medical risk to the workers as a result of dehydration. Consequently, in these areas food employees are allowed to drink from closed containers that are carefully handled.

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PREVENTING CONTAMINATION BY HANDS

F005 - NO BARE HAND CONTACT WITH READY-TO-EAT FOODS

760-1335.2 Infected food employees are the source of contamination in approximately one in five foodborne disease outbreaks reported in the United States with a bacterial or viral cause. Most of these outbreaks involve enteric, i.e., fecal-oral agents. These are organisms that employees were shedding in their stools at the time the food was prepared. Because of poor or nonexistent handwashing procedures, workers spread these organisms to the food. In addition, infected cuts, burns, or boils on hands can also result in contamination of food. Viral, bacterial, and parasitic agents can be involved. Traditionally, food regulations have required two methods of preventing the spread of foodborne disease by this mode of transfer, i.e., they have prohibited food workers from preparing food when they are infectious and have required thorough and frequent handwashing. In order to strengthen fecal-oral transmission interventions, the sanitary code provides focused and specific guidance about ill workers and when handwashing must occur. As a final barrier, bare-hand contact with ready-to-eat food (i.e., food that is edible without washing or is not subsequently subjected to a pathogen kill step) is prohibited and suitable utensils such as spatulas, tongs, single-use gloves, or dispensing equipment are required to be used.

The three interdependent critical factors in reducing foodborne illness transmitted through the fecal-oral route include exclusion/restriction of ill food workers, proper handwashing, and no bare hand contact with ready-to-eat foods. Each of these factors is inadequate when utilized independently and may not be effective. However, when all three factors are combined and utilized properly, the transmission of fecal-oral pathogens can be controlled. Depending on the microbial contamination level on the hands, handwashing with plain soap and water, as specified in the sanitary code, may not be an adequate intervention to prevent the transmission of pathogenic microbes to ready-to-eat foods via hand contact with ready-to-eat foods. Handwashing as specified in the sanitary code will reduce microbial contamination of the hands by 2-3 logs.

Food employees infected with fecal-oral pathogens can shed viral and protozoan pathogens in the feces at levels up to 10⁸ viral particles or oocysts per gram of feces. Having a high potential contamination level on the hands combined with a very low infectious dose necessary to cause infection are the reasons that the US Food and Drug Administration believes that handwashing alone is not an effective single barrier in the transmission of these fecal-oral pathogens. The infective dose for Giardia and Cryptosporidium is believed to be as low as 1-10 oocysts, and as few as 10 virus particles can infect an individual with Norovirus or Hepatitis A.

The Centers for Disease Control now estimates that Norovirus is the leading cause of foodborne illness in the United States. Contaminated hands are a significant factor in the transmission of enteric viruses, including Norovirus and Hepatitis A virus. Further, contamination of food by an infected food worker is the most common mode of transmission of Hepatitis A in foodborne disease outbreaks. Research has shown the viral transfer rate from contaminated hands to ready-to-eat food to be about 10% and that proper handwashing will significantly reduce the chance of transmitting pathogenic viruses. However, with heavy initial contamination of the hands, especially in the subungal space of the fingers, a basic 2-3 log reduction hand wash procedure may not be adequate to prevent the transmission of viral foodborne illness.

Even though bare hands should never contact exposed, ready-to-eat food, thorough handwashing is important in keeping gloves or other utensils from becoming vehicles for transferring microbes to the food.

760-1341.c Gloved hands may become contaminated when the food employee engages in specific activities. The increased risk of contamination requires replacement of gloves between different tasks, when damaged or soiled, or when interruptions occur in the food task, and when the task exceeds one hour. Bacterial loads increase inside a glove over time, and increased time of use increases the likelihood of tears or rips. Washing of hands prior to donning gloves has been demonstrated to decrease the rate of bacterial growth inside gloves.

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F006 - PROPER HANDWASHING

760-1341.1.b The hands are particularly important in transmitting foodborne pathogens. Food employees with dirty hands and/or fingernails may contaminate the food being prepared. Therefore, any activity which may contaminate the hands must be followed by thorough handwashing in accordance with the procedures outlined in the sanitary code. Even seemingly healthy employees may serve as reservoirs for pathogenic microorganisms that are transmissible through food. Staphylococci, for example, can be found on the skin and in the mouth, throat, and nose of many employees. The hands of employees can be contaminated by touching their nose or other body parts. Many employees fail to wash their hands as often as necessary and even those who do may use a flawed technique. It takes more than just the use of soap and running water to remove the transient pathogens that may be present. It is the abrasive action obtained by vigorously rubbing the surfaces being cleaned that loosens the dirt or soil present. Many of the diseases that are transmissible through food may be harbored in the employee’s intestinal tract and shed in the feces. Proper handwashing by employees after defecation establishes a protective barrier against the transmission of pathogens that may be present in the feces. Pathogens transmissible through food may also be present in other body fluids. Therefore, precautions would be appropriate whenever an employee handles body fluids or body wastes directly or indirectly, because of the increased risk of the presence of disease. Fecal material and other contaminants routinely accumulate under the fingernails; therefore, particular attention must be given to the fingernails, fingertips, and areas between the fingers. Once the material and soil are loosened, they can be washed away in the rinsing step of proper handwashing.

760-1341.2 The term “sanitizer” is typically used to describe a chemical agent used to control bacterial contamination of inert objects or articles, or equipment and utensils, and other cleaned food-contact surfaces.

Sanitizers used to disinfect food-contact equipment and utensils can easily achieve a 5-log reduction of microorganisms and often far exceed this minimum requirement. However, removing microorganisms from human skin is a totally different process and sterilization of human skin is nearly impossible to achieve without damaging the skin. Many antimicrobial hand agents typically achieve a much smaller reduction in microorganisms than the 5-log reduction required for “sanitization.” The provisions of this code section are intended to ensure that an antimicrobial product applied to the hands is 1) safe and effective when applied to human skin, and 2) a safe food additive when applied to bare hands that will come into direct contact with food.

760-1354.1 Hands are a common vehicle for transmission of pathogens to foods in a food establishment. Hands can become soiled with a variety of contaminants during routine operations. The transfer of contaminants can be limited by providing food employees with handwashing sinks that are properly equipped and conveniently located.

A handwashing sink that is properly located is one that is available to food employees who are working in food preparation, food dispensing, and ware washing areas. Handwashing sinks that are blocked by portable equipment or stacked full of soiled utensils and other items, are rendered unavailable for employee use. Nothing must block the approach to a handwashing sink thereby discouraging its use, plus it must be kept clean and well stocked with soap and sanitary towels to facilitate frequent use. Therefore, a handwashing sink that is located in the immediate work area, or between work areas that the sanitary code states must be equipped with handwashing sinks, depending upon the size and function of the facility, would be considered properly located. Such placement of handwashing sinks facilitates frequent handwashing by food employees in all work areas.

Hand cleanser must always be present to aid in reducing microorganisms and particulate matter found on hands.

Warm water is more effective than cold water in removing the fatty soils encountered in kitchens. An adequate flow of warm water will cause soap to lather and aid in flushing soil quickly from the hands. ASTM Standards for testing the efficacy of handwashing formulations specify a water temperature of 100 to 108°F (40°C ± 2°C).

An inadequate flow or temperature of water may lead to poor handwashing practices by food employees. A mixing valve or combination faucet is needed to provide properly tempered water for handwashing. Steam mixing valves are not allowed for this use because they are hard to control and injury by scalding is a possible hazard.

Provisions must be provided for hand drying so that employees will not dry their hands on their clothing or other unclean materials. It is known that wet hands transfer bacteria more readily than dry hands. The residual moisture found on the hands after washing allows for bacterial and viral transfer to food or solid surfaces by touch. The method in which hands are dried is a critical factor in reducing chances of cross-contamination by hands to food and environmental surfaces.

760-1354.2 Sinks used for food preparation or utensil washing, and service sinks or curbed cleaning facilities used for the disposal of mop water or similar wastes are more likely than dedicated hand washing sinks to be contaminated with pathogens that can be transferred to the hands during hand washing activities.

APPROVED SOURCE

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F007 - FOOD OBTAINED FROM APPROVED SOURCE

760-1315 A primary line of defense in ensuring that food prepared and served in food establishments is safe is to obtain food from approved sources. However, it is also critical to monitor food products to ensure that, after harvesting and processing, they do not fall victim to conditions that endanger their safety, make them adulterated, or compromise their honest presentation. The regulatory community, industry, and consumers should exercise vigilance in controlling the conditions to which foods are subjected and be alert to signs of abuse.

Food, at all stages of production, is susceptible to contamination. The source of food is important because pathogenic microorganisms may be present in the breeding stock of farm animals, in feeds, in the farm environment, in waters used for raising and freezing aquatic foods, and in soils and fertilizers in which plant crops are grown. Chemical contaminants that may be present in field soils, fertilizers, irrigation water, and fishing waters can be incorporated into food plants and animals.

The identity of a food in terms of origin and composition is important for instances when a food may be implicated in a foodborne illness and for nutritional information requirements. Ingredient information is needed by consumers who have allergies to certain food or ingredients. The appearance of a food should not be altered or disguised because it is a cue to the consumer of the food's identity and condition.

760-1315.a Food should be purchased from commercial supplies under regulatory control. Home kitchens, with their varieties of food and open entry to humans and pet animals, are frequently implicated in the microbial contamination of food. Because commercial items seldom are eaten right away, the home kitchen's limited capacity for maintaining food at proper temperatures may result in considerable microbial growth and toxin production by microorganisms introduced through the diverse sources of contamination. Controlled processing is required for the safe preparation of food in regulated operations.

760-1315.b Processing food at the proper high temperature for the appropriate time is essential to kill bacterial spores that, under certain conditions in an airtight container, begin to grow and produce toxin. Of special concern is the lethal toxin of Clostridium botulinum, an organism whose spores (i.e., survival stages for non-growth conditions) are found throughout the environment. Even slight underprocessing of low acid food which is canned can be dangerous, because spoilage microbes are killed and there are no signs to warn consumers that botulinum spores have germinated into vegetative cells and produced their toxin. If these foods are not processed to be commercially sterile, they must be received frozen or under proper refrigeration.

760-1315.h Bottled water must be obtained from a public water system or from a private source such as a spring or well, and its production must be controlled by public health law to protect the consumer from contaminated water.

760-1315.i As a safeguard for highly susceptible populations from the risk of contracting foodborne illness from juice, prepackaged juice is required to be obtained pasteurized or in a commercially sterile, shelf-stable form in a hermetically sealed container. It is important to note that “juice” means it is served as such or used as an ingredient in beverages. Puréed fruits and vegetables, which are commonly prepared as food for service to highly susceptible populations, are not juices and do not require HACCP plans or compliance with 21 CFR Part 120. There are documented cases of foodborne illness throughout the United States that were associated with the consumption of various juice products contaminated with microorganisms such as Cryptosporidium, Shiga toxin-producing Escherichia coli, Salmonella spp., and Vibrio cholera.

760-1316.3 Fluid milk and milk products are especially good growth media for many types of bacteria and must be pasteurized. Pasteurization is a heat process that will kill or inactivate bacteria and other harmful microorganisms likely to be in these time/temperature control for safety foods.

Milk, which is a staple for infants and very young children with incomplete immunity to infectious diseases, is susceptible to contamination with a variety of microbial pathogens such as Shiga toxin-producing Escherichia coli, Salmonella spp., and Listeria monocytogenes, and provides a rich medium for their growth. Pasteurization is required to eliminate pathogen contamination in milk and products derived from milk. Dairy products are normally perishable and must be received under proper refrigeration conditions.

760-1318.1 Sources of molluscan shellfish are a particular concern because shellfish are frequently consumed raw or in an undercooked state and thus receive neither heat treatment nor any other process that would destroy or inactivate microbial pathogens. For safety, these foods must be accompanied by certification that documents that they have been harvested from waters that meet the water quality standards contained in the National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish. Certification also provides confidence that processing, packaging, and shipping have been conducted under sanitary conditions.

Dirty, damaged, or dead shellstock can contaminate and degrade live and healthy shellstock and lead to foodborne illness. Harvesters have the primary responsibility for culling shellstock, but this responsibility continues throughout the distribution chain.

760-1319.1 The New York State Department of Environmental Conservation (NYSDEC) regulates marine fisheries in New York State, and is responsible for ensuring the safety of the waters and fish and crustaceans harvested from those waters. NYSDEC works closely with its stakeholders to protect the sustainability of the commercial fishing industry as well as the living marine resources of New York's marine and coastal district. Requiring that fish and crustaceans harvested from New York’s marine waters be obtained from licensed dealers and fishermen ensures that they are handled, processed and transported under regulations designed to ensure a safe food product.

760-1320.1 The U.S. Department of Agriculture (USDA) is responsible for ensuring that meat, poultry, and processed egg products are safe, wholesome, and accurately labeled. USDA ensures safety through a series of policies and regulations that define how meat processing establishments can operate to produce a safe and wholesome product. USDA mandates that meat processors have a Hazard Analysis and Critical Control Point (HACCP) plan. HACCP requires processors to think about all of the hazards along the slaughter and production process to control and reduce risks and to ensure a safe product for consumers. USDA verifies that these plans are in place and working effectively.

USDA is also responsible to help reduce the harm associated with allergens (such as egg, soy, milk, peanuts, tree nuts, fish, and shellfish), mislabeled product, illegal chemical residues, and foreign material entering food during production.

760-1321.2.b Damaged egg shells permit the entry of surface bacteria to the inside of eggs. Eggs are an especially good growth medium for many types of bacteria. Damaged eggs must not be used as food.

760-1321.4 Federal regulations require that shell egg cartons bear safe handling instructions and be placed under refrigeration at 45°F or lower upon delivery at retail establishments. These rules are one part of a larger farm-to-table approach for ensuring the safety of our nation’s egg supply.

760-1324 Some wild mushrooms that are extremely poisonous may be difficult to distinguish from edible species. Over 5000 species of fleshy mushrooms grow naturally in North America. The vast majority have never been tested for toxicity. It is known that about 15 species are deadly and another 60 are toxic to humans whether they are consumed raw or cooked. An additional 36 species are suspected of being poisonous, whether raw or cooked. At least 40 other species are poisonous if eaten raw, although they are safe after proper cooking.

760-1325.2 The primary concern regarding game animals relates to animals obtained in the wild. Wild game animals may be available as a source of food only if a regulatory inspection program is in place to ensure that wild animal products are safe. This is important because wild animals may be carriers of viruses, rickettsiae, bacteria, or parasites that cause illness (zoonoses) in humans. Some of these diseases can be severe in the human host. In addition to the risk posed to consumers of game that is not subject to an inspection program, there is risk to those who harvest and prepare wild game because they may contract infectious diseases such as rabies or tularemia.

760-1331.2 Food that contains any pathogenic organism has a high risk of transmitting disease, is considered to be adulterated and must not be served.

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F008 - FOOD RECEIVED AT PROPER TEMPERATURES

760-1318.5 Temperature is one of the prime factors that controls the growth of bacteria in food. Many, though not all, types of pathogens and spoilage bacteria are prevented from multiplying to microbiologically significant levels in properly refrigerated foods.

Pathogens, such as Vibrio vulnificus, Vibrio parahaemolyticus, Vibrio cholerae, and Listeria monocytogenes that may be present in low numbers at the time that molluscan shellfish are harvested, may increase to more hazardous levels if they are exposed to time/temperature abuse. To minimize the risk of pathogen growth, Shellfish Control Authorities place limits on the time between harvest and refrigeration.

760-1319.10 Smoked fish products have been associated with illness outbreaks caused by Clostridium botulinum, type E. The spores of C. botulinum are very common in nature. C. botulinum, type E is the most common form found in fresh water and marine environments, and can be found in the gills and viscera of fin fish, crabs, and shellfish. The minimum temperature for growth of C. botulinum, type E and toxin formation is 38°F. Ensuring that smoked fish is received and stored at 38^oF or less is a control point that prevents the growth of the bacterium and formation of toxin.

760-1321.2.a Bacterial growth and/or toxin production can occur if time/temperature control for safety food, including shell eggs, remains in the temperature "Danger Zone" of 41^oF to 140^oF (5^oC to 60^oC) too long. Up to a point, the rate of growth increases with an increase in temperature within this zone.

760-1332.3 Bacterial growth and/or toxin production can occur if time/temperature control for safety (TCS) food remains in the temperature "Danger Zone" of 41^oF to 140^oF (5^oC to 60^oC) too long. Up to a point, the rate of growth increases with an increase in temperature within this zone.

Maintaining TCS foods under the cold temperature control requirements prescribed in the sanitary code will limit the growth of pathogens that may be present in or on the food and may help prevent foodborne illness. All microorganisms have a defined temperature range in which they grow, with a minimum, maximum, and optimum. An understanding of the interplay between time, temperature, and other intrinsic and extrinsic factors is crucial to selecting the proper storage conditions for a food product. Temperature has dramatic impact on both the generation time of an organism and its lag period.

When considering growth rate of microbial pathogens, time and temperature are integral and must be considered together. Increases in storage and/or display temperature will decrease the shelf life of refrigerated foods since the higher the temperature, the more permissive conditions are for growth.

The minimum hot holding temperature specified in the sanitary code must:

Be greater than the upper limit of the range of temperatures at which Clostridium perfringens and Bacillus cereus may grow; and
Provide a margin of safety that accounts for variations in food matrices, variations in temperature throughout a food product, and the capability of hot holding equipment to consistently maintain product at a desired target temperature.

C. perfringens has been reported to grow at temperatures up to 126°F (52°C). Growth at this upper limit requires anaerobic conditions and follows a lag phase of at least several hours. The literature shows that lag phase duration and generation times are shorter at incubation temperatures below 120°F (49°C) than at 125°F (52°C). Studies also suggest that temperatures that preclude the growth of C. perfringens also preclude the growth of B. cereus. CDC estimates that approximately 250,000 foodborne illness cases can be attributed to C. perfringens and B. cereus each year in the United States. These spore-forming pathogens have been implicated in foodborne illness outbreaks associated with foods held at improper temperatures. This suggests that preventing the growth of these organisms in food by maintaining adequate hot holding temperatures is an important public health intervention.

Maintaining food at a temperature of 140°F (60°C) or greater during hot holding is sufficient to prevent the growth of pathogens and is therefore an effective measure in the prevention of foodborne illness.

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F009 - FOOD IN GOOD CONDITION, SAFE, UNADULTERATED

760-1330.1 Pathogens can contaminate and/or grow in food that is not stored properly. Drips of condensate and drafts of unfiltered air can be sources of microbial contamination for stored food. Shoes carry contamination onto the floors of food preparation and storage areas. Even trace amounts of refuse or wastes in rooms used as toilets or for dressing, storing garbage or implements, or housing machinery can become sources of food contamination. Moist conditions in storage areas promote microbial growth.

Food preparation activities may expose food to an environment that may lead to the food's contamination. Just as food must be protected during storage, it must also be protected during preparation. Sources of environmental contamination may include splash from cleaning operations, drips from overhead air conditioning vents, or air from an uncontrolled atmosphere such as may be encountered when preparing food in a building that is not constructed according to sanitary code requirements.

Food may also become adulterated when contaminated by an ill food worker or exposed to rodent or insect contact.

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F010 - REQUIRED RECORDS AVAILABLE - SHELLFISH TAGS, PARASITE DESTRUCTION

760-1318.3 Accurate source identification of the harvesting area, harvester, and dealers must be contained on molluscan shellstock identification tags so that if a shellfish-borne disease outbreak occurs, the information is available to expedite the epidemiological investigation and regulatory action.

Accurate records that are maintained in a manner that allows them to be readily matched to each lot of shellstock provide the principal mechanism for tracing shellstock to its original source. If an outbreak occurs, regulatory authorities must move quickly to close affected growing areas or take other appropriate actions to prevent further illnesses. Records must be kept for 90 days to allow time for Hepatitis A virus infections, which have an incubation period that is significantly longer than other shellfish-borne diseases, to come to light.

The 90-day “clock” starts at the time the container of shellstock is emptied because the shellstock may be sold/consumed in less than the estimated 14 days of shelf life. Therefore, the 90 days may expire and the tag may be discarded before an illness is reported and investigated.

760-1318.4 Pathogens found in waters from which molluscan shellfish are harvested can cause disease in consumers. Molluscan shellfish include: 1) oysters; 2) clams; 3) mussels; and, 4) scallops, except where the final product is the shucked adductor muscle only. The pathogens of concern include both bacteria and viruses. Pathogens from the harvest area are of particular concern in molluscan shellfish because: 1) environments in which molluscan shellfish grow are commonly subject to contamination from sewage, which may contain pathogens, and to naturally occurring bacteria, which may also be pathogens; 2) molluscan shellfish filter and concentrate pathogens that may be present in surrounding waters; and, 3) molluscan shellfish are often consumed whole, either raw or partially cooked. To minimize the risk of molluscan shellfish containing pathogens of sewage origin, state and foreign government agencies, called Shellfish Control Authorities, classify waters in which molluscan shellfish are found, based, in part, on an assessment of water quality. As a result of these classifications, molluscan shellfish harvesting is allowed from some waters, not from others, and only at certain times or under certain restrictions from others. Shellfish Control Authorities then exercise control over the molluscan shellfish harvesters to ensure that harvesting takes place only when and where it has been allowed.

Lot separation is critical to isolating shellfish implicated in illness outbreaks and tracking them to their source. Proper identification is needed for tracing the origin and determining conditions of shellfish processing and shipment. If the lots are commingled in a food establishment, traceability is undermined and the root of the problem may remain undetected. If no causative factors are identified in the food establishment, tracing the incriminated lot helps in identifying products that need to be recalled or growing waters that may need to be closed to harvesting.

760-1318.6 Plastic containers commonly used throughout the shellfish industry for shucked product bear specific information regarding the source of the shellfish as required by the National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish. These containers must be nonreturnable so that there is no potential for their subsequent reuse by shellfish packers which could result in shucked product that is inaccurately identified by the label. The reuse of these containers within the food establishment must be assessed on the basis of the sanitary code's criteria for multi-use containers and the likelihood that they will be properly relabeled to reflect their new contents.

760-1318.7 Similar to shellstock whose original containers must bear tags that identify the source of the product, containers of shucked shellfish bear source identification information that may be lost if the shellfish are removed from the original container. This information is vital to regulatory authorities to expedite an epidemiological investigation and regulatory action if a shellfish-borne disease outbreak occurs.

760-1319.11.b Lightly cooked, raw, raw-marinated, and cold-smoked fish may be desired by consumers for taste or perceived nutritional reasons. In order to ensure destruction of parasites, fish may be frozen before service as an alternative public health control to that which is provided by adequate cooking. Candling or other visual inspection techniques are not adequate to avoid the risk of parasites from fish which have not been frozen. The recommended control strategies refer to the ambient air temperature during freezing and to the length of time that the fish is held at the appropriate freezer temperature, or the length of time that the fish is held after it is solid frozen, whichever it appropriate. The parasite hazard is not considered to be reasonably likely to occur if the finished product is fish eggs that have been removed from the skein (the tissue that contains the egg mass) and rinsed. In response to information provided to the FDA Office of Seafood, the Fish and Fishery Hazards and Controls Guide lists certain species of tuna as not being susceptible to parasites of concern and therefore are exempted from the freezing requirements for other fish species that are consumed raw.

760-1319.11.c Records must be maintained to verify that the critical limits required for food safety, in this case, freezing to destroy parasite hazards, are being met. Records provide a check for both the operator and the Department in determining that monitoring and corrective actions have taken place.

760-1319.11.d Records must be maintained to verify that the critical limits required for food safety, in this case, freezing to destroy parasite hazards, are being met. Records provide a check for both the operator and the Department in determining that monitoring and corrective actions have taken place.

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PROTECTION FROM CONTAMINATION

F011 - FOOD SEPARATED AND PROTECTED

760-1334.1 Storage of food above the floor allows for surveillance of rodent and insect activity and facilitates cleaning activities. Proper design of case lot handling equipment facilitates moving case lots for cleaning and for surveillance of insect or rodent activity.

760-1334.2 Pathogens can contaminate and/or grow in food that is not stored (covered) properly. Drips of condensate and drafts of unfiltered air can be sources of microbial contamination for stored food.

Moist conditions in refrigerated storage units promote microbial growth. Shelves in refrigerated storage units are a potential source of contamination.

760-1334.3 Raw foods of animal origin usually contain pathogens. These foods must be stored so that the potential to introduce pathogens to foods that will be served without further cooking (e.g., via drippage or splash) is eliminated. Cooking raw animal foods to temperatures required by the sanitary code is a critical control point that “kills” pathogenic organisms; since ready-to-eat foods are served without cooking, or are cooked and stored for service without further cooking, no additional control point prevents contamination of the food.

Additionally, raw animal foods must be separated in storage based on a succession of cooking temperatures since cooking temperatures as specified in the sanitary code are based on thermal destruction data and anticipated microbial load. For example, to prevent cross-contamination, fish and pork, which are required to be cooked to an internal temperature of 145°F for 15 seconds, must be stored above or away from raw poultry, which is required to be cooked to an internal temperature of 165°F for 15 seconds due to its considerably higher anticipated microbial load. In addition, raw animal foods having the same cooking temperature, such as pork and fish, must be separated from one another during storage and preparation by maintaining adequate spacing or by placing the food in separate containers because of the potential for allergen cross-contamination or economic adulteration via inadvertent species substitution. An exception is permitted for frozen, commercially packaged raw animal food to be stored or displayed adjacent to or above frozen, commercially packaged ready-to-eat food. The freezer equipment should be designed and maintained to keep foods in the frozen state. Corrective action should be taken if the storage or display unit loses power or otherwise fails.

760-1334.4 Packages that are not watertight may allow entry of water that has been exposed to unsanitary exterior surfaces of packaging, causing the food to be contaminated. Unpackaged foods such as fresh fish are often stored and/or displayed on ice. A potential for increasing the microbial load of a food exists because, as the ice melts, pathogens from one food may be carried by water to other foods. The potential for contamination is reduced by continuous draining of melting ice.

760-1334.7 Food that is inadequately packaged or contained in damaged packaging could become contaminated by microbes, dust, or chemicals introduced by products or equipment stored in close proximity or by persons delivering, stocking, or opening packages or overwraps. Packaging must be appropriate for preventing the entry of microbes and other contaminants such as chemicals. These contaminants may be present on the outside of containers and may contaminate food if the packaging is inadequate or damaged, or when the packaging is opened. The removal of food product overwraps

may also damage the package integrity of foods under the overwraps if proper care is not taken.

760-1335.1 During display, food can be contaminated even when there is no direct hand contact. Many microbes can be conveyed considerable distances on air currents through fine sprays or aerosols. These may originate from people breathing or sneezing, water sprays directed at drains, or condensate from air conditioners. Even wind gusts across sewage deposits and fertilized fields have been known to contaminate food in adjacent establishments where food was unprotected. Unpackaged condiments are exposed to contamination by consumers who could be suffering from a disease transmissible through food. Once the condiments are contaminated, subsequent consumers using the condiments may be exposed to pathogens. Condiments in individual packages are protected from consumer contamination.

Self-service operations of ready-to-eat foods also provide an opportunity for contamination by consumers. The risk of contamination can be reduced by supplying clean utensils and dispensers and by employee monitoring of these operations to ensure that the utensils and dispensers are properly used.

760-1335.1.a Raw foods of animal origin usually contain pathogens. In addition, these foods, if offered for consumer self-service, could cross contaminate other foods stored in the same display. Because raw foods of animal origin are assumed to be contaminated and provide an ideal medium for the growth of pathogenic organisms, they should not be available for consumer self-service.

760-1341.1.c Gloves used in touching ready-to-eat food are defined as a "utensil" and must meet the applicable requirements related to utensil construction, good repair, cleaning, and storage. Requiring frequent changes of single-use gloves and thorough hand washing when re-gloving is required reduces the microbial load on the hands, which can build up in the moist, warm environment created by wearing single-use gloves. Proper handwashing between consecutive uses of single-use gloves will significantly reduce the potential of transmitting pathogenic microbes.

Multiuse gloves, especially when used repeatedly and soiled, can become breeding grounds for pathogens that could be transferred to food. Soiled gloves can directly contaminate food if stored with ready-to-eat food or may indirectly contaminate food if stored with articles that will be used in contact with food. Multiuse gloves must be washed, rinsed, and sanitized between activities that contaminate the gloves. Hands must be washed before donning gloves. Gloves must be discarded when soil or other contaminants enter the inside of the glove.

Slash-resistant gloves are not easily cleaned and sanitized. Their use with ready-to-eat foods could contaminate the food.

760-1341.1.k Prohibiting re-use of a utensil used for tasting food reduces the potential for transmission of disease-causing pathogens that may be present in the saliva of the food worker, or transferred to the utensil from the storage location if the utensil is re-used without proper cleaning and sanitizing.

760-1346.3.b Microorganisms may be transmitted from a raw animal food to another raw animal food by utensils, cutting boards, thermometers, or other food-contact surfaces. Food-contact surfaces and equipment used for time/temperature control for safety foods should be cleaned and sanitized as needed to prevent transfer of pathogenic microorganisms from one food to another.

760-1346.3.c Microorganisms may be transmitted from a raw animal food to a ready-to-eat food by utensils, cutting boards, thermometers, or other food-contact surfaces. Food-contact surfaces and equipment used for time/temperature control for safety foods should be cleaned and sanitized as needed to prevent transfer of pathogenic microorganisms from raw animal foods to ready-to-eat foods.

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F012 - FOOD CONTACT SURFACES - CLEANED AND SANITIZED

760-1346.1 Pathogens can be transferred to food from utensils that have been stored on surfaces which have not been cleaned and sanitized. They may also be passed on by consumers or employees directly, or indirectly from used tableware or food containers. Some pathogenic microorganisms survive outside the body for considerable periods of time. Food that comes into contact directly or indirectly with surfaces that are not clean and sanitized is liable to such contamination. The handles of utensils, even if manipulated with gloved hands, are particularly susceptible to contamination. Probe-type price or identification tags are defined as a utensil.

760-1346.3.a Microorganisms may be transmitted from a food to other foods by utensils, cutting boards, thermometers, or other food-contact surfaces. Food-contact surfaces and equipment used for time/temperature control for safety (TCS) foods should be cleaned as needed throughout the day but must be cleaned no less than every 4 hours to prevent the growth of microorganisms on those surfaces.

Refrigeration temperatures slow down the generation time of bacterial pathogens, making it unnecessary to clean every four hours. However, the time period between cleaning equipment and utensils may not exceed 24 hours.

Surfaces of utensils and equipment contacting food that is not TCS such as iced tea dispensers, carbonated beverage dispenser nozzles, beverage dispensing circuits or lines, water vending equipment, coffee bean grinders, ice makers, and ice bins must be cleaned on a routine basis to prevent the development of slime, mold, or soil residues that may contribute to an accumulation of microorganisms. Some equipment manufacturers and industry associations, e.g., within the tea industry, develop guidelines for regular cleaning and sanitizing of equipment. If the manufacturer does not provide cleaning specifications for food-contact surfaces of equipment that are not readily visible, the person in charge should develop a cleaning regimen that is based on the soil that may accumulate in those particular items of equipment.

760-1346.4 Food-contact surfaces of cooking equipment must be cleaned to prevent encrustations that may impede heat transfer necessary to adequately cook food. Encrusted equipment may also serve as an insect attractant when not in use. Because of the nature of the equipment, it may not be necessary to clean cooking equipment as frequently as non-cooking equipment.

760-1346.5 The objective of cleaning focuses on the need to remove organic matter from food contact surfaces so that sanitization can occur and to remove soil from nonfood contact surfaces so that pathogenic microorganisms will not be allowed to accumulate and insects and rodents will not be attracted.

Sanitization is accomplished after the ware washing steps of cleaning and rinsing so that utensils and food-contact surfaces are sanitized before coming in contact with food and before use.

760-1346.5.a During production, raw shell eggs may be contaminated with Salmonella enteritidis, which is normally eliminated by cooking to the temperature required in the sanitary code. Some food establishments, in the interest of efficient service, may continuously use the same utensils to prepare raw shell egg dishes, storing the utensils at ambient temperature between uses without cleaning and sanitizing. This practice can allow S. enteritidis to multiply to levels that can cause illness if the equipment is used to prepare eggs that are not subsequently cooked to temperatures required by the sanitary code (at the consumer’s request, e.g., “over easy”). Requiring that utensils used to prepare raw shell eggs be cleaned and sanitized at least hourly eliminates the potential for S. enteritidis proliferation during continuous equipment use.

760-1346.6 The objective of cleaning focuses on the need to remove soil from nonfood contact surfaces so that pathogenic microorganisms will not be allowed to accumulate and insects and rodents will not be attracted.

The presence of food debris or dirt on nonfood contact surfaces may provide a suitable environment for the growth of microorganisms which employees may inadvertently transfer to food. If these areas are not kept clean, they may also provide a food source and harborage for insects, rodents, and other pests.

760-1346.13.g.1 If the temperature during the hot water sanitizing step is less than 171^oF (77^oC), sanitization will not be achieved. As a result, pathogenic organisms may survive and be subsequently transferred from utensils to food. The time hot water contacts utensils or food-contact surfaces must be sufficient to destroy pathogens that may remain on surfaces after cleaning. Other parameters, such as rinse pressure, temperature, and chemical concentration are used in combination with time to achieve sanitization.

760-1346.13.g.2 The effectiveness of chemical sanitizers can be directly affected by the temperature, pH, concentration of the sanitizer solution used, hardness of the water, and sanitizer/equipment contact time. If any of these parameters are not met, the chemical sanitization process is ineffective, leaving microbial contamination on equipment, and potentially transferring the contamination to food.

The effectiveness of chemical sanitizers is determined primarily by the concentration and pH of the sanitizer solution. Therefore, a test kit is necessary to accurately determine the concentration of the chemical sanitizer solution.

760-1346.13.g.3 Some chemical sanitizers are not compatible with detergents when a 2 compartment operation is used. When using a sanitizer that is different from the detergent-sanitizer of the wash compartment, the sanitizer may be inhibited by carry-over, resulting in inadequate sanitization.

760-1346.14.a To ensure properly cleaned and sanitized equipment and utensils, ware washing machines must be operated properly. The manufacturer affixes a data plate to the machine providing vital, detailed instructions about the proper operation of the machine including wash, rinse, and sanitizing cycle times and temperatures which must be achieved.

Flow pressure is a very important factor with respect to the efficacy of sanitization. A pressure below the design pressure results in inadequate spray patterns and incomplete coverage of the utensil surfaces to be sanitized. Excessive flow pressure will tend to atomize the water droplets needed to convey heat into a vapor mist that cools before reaching the surfaces to be sanitized.

It is important that the operator be able to monitor, and the food inspector be able to check, final sanitization rinse pressure as well as machine water temperatures. ANSI/NSF Standard #3, a national voluntary consensus standard for Commercial Spray-Type Dishwashing Machines, specifies that a pressure gauge or similar device be provided on this type machine and such devices are shipped with machines by the manufacturer. Flow pressure devices installed on the upstream side of the control (solenoid) valve are subject to damage and failure due to the water hammer effect caused throughout the dishwashing period each time the control valve closes. The IPS valve provides a ready means for checking line-pressure with an alternative pressure measuring device. A flow pressure device is not required on machines that use only a pumped or recirculated sanitizing rinse since an appropriate pressure is ensured by a pump and is not dependent upon line-pressure.

The presence of baffles or curtains separating the various operational cycles of a ware washing machine such as washing, rinsing, and sanitizing are designed to reduce the possibility that solutions from one cycle may contaminate solutions in another. The baffles or curtains also prevent food debris from being splashed onto the surface of equipment that has moved to another cycle in the procedure.

760-1346.14.e If the flow pressure of the final sanitizing rinse is less than that required, dispersion of the sanitizing solution may be inadequate to reach all surfaces of equipment or utensils.

760-1346.14.i The wash solution temperature in mechanical ware washing equipment is critical to proper operation. The chemicals used may not adequately perform their function if the temperature is too low. Therefore, the manufacturer's instructions must be followed. The temperatures vary according to the specific equipment being used.

The temperature of hot water delivered from a ware washer sanitizing rinse manifold must be maintained according to the equipment manufacturer’s specifications and temperature limits specified in this section to ensure surfaces of multiuse utensils such as kitchenware and tableware accumulate enough heat to destroy pathogens that may remain on such surfaces after cleaning.

The utensil surface temperature must reach at least 160ºF (71ºC) as measured by an irreversible registering temperature measuring device to affect sanitization. When the sanitizing rinse temperature exceeds 194ºF (90ºC) at the manifold, the water becomes volatile and begins to vaporize reducing its ability to convey sufficient heat to utensil surfaces. The lower temperature limits of 165ºF (74ºC) for a stationary rack, single temperature machine, and 180ºF (82ºC) for other machines are based on the sanitizing rinse contact time required to achieve the 160ºF (71ºC) utensil surface temperature.

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F013 - PROPER DISPOSITION OF RETURNED, PREVIOUSLY SERVED AND UNSAFE FOOD

760-1335.6 Food can serve as a means of person-to-person transmission of disease agents such as Hepatitis A virus. Any unpackaged foods, even bakery goods in a bread basket that are not time/temperature control safety foods and that have been served to a consumer, but not eaten, can become vehicles for transmitting pathogenic microorganisms from the initial consumer to the next if the food is served again.

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TCS FOOD TEMPERATURE/TIME

F014 - PROPER COOKING TIME AND TEMPERATURES, STEM THERMOMETERAVAILABLE AND USED

760-1332.2 The presence and accessibility of food temperature measuring devices is critical to the effective monitoring of food temperatures. Proper use of such devices provides the operator or person in charge with important information with which to determine if temperatures should be adjusted or if foods should be discarded.

When determining the temperature of thin foods, those having a thickness less than 1/2 inch (13 mm), it is particularly important to use a temperature sensing probe designed for that purpose. Bimetal, bayonet style thermometers are not suitable for accurately measuring the temperature of thin foods such as hamburger patties because of the large diameter of the probe and the inability to accurately sense the temperature at the tip of the probe. However, temperature measurements in thin foods can be accurately determined using a small-diameter probe 0.059 inch (1.5 mm), or less, connected to a device such as thermocouple thermometer.

The small margin of error specified for thermometer accuracy is due to the lack of a large safety margin in the temperature requirements themselves. The accuracy specified for a particular food temperature measuring device is applicable to its entire range of use, that is, from refrigeration through cooking temperatures if the device is intended for such use.

760-1333.2 Raw or undercooked eggs that are used in certain dressings or sauces are particularly hazardous because Salmonella enteritidis may be present in raw shell eggs. Pasteurized eggs provide an egg product that is free of pathogens and is a ready-to-eat food. The pasteurized product should be substituted in a recipe that requires raw or undercooked eggs.

760-1333.8 Cooking, to be effective in eliminating pathogens, must be adjusted to a number of factors. These include the anticipated level of pathogenic bacteria in the raw product, the initial temperature of the food, and the food's bulk which affects the time to achieve the needed internal product temperature. Other factors to be considered include post-cooking heat rise and the time the food must be held at a specified internal temperature.

Cooking requirements are based in part on the biology of pathogens. The thermal destruction of a microorganism is determined by its ability to survive heat. Different species of microorganisms have different susceptibilities to heat. Also, the growing stage of a species (such as the vegetative cell of bacteria, the trophozoite of protozoa, or the larval form of worms) is less resistant than the same organism's survival form (the bacterial spore, protozoan cyst, or worm egg).

Food characteristics also affect the lethality of cooking temperatures. Heat penetrates into different foods at different rates. High fat content in food reduces the effective lethality of heat. High humidity within the cooking vessel and the moisture content of food aid thermal destruction.

Greater numbers and varieties of pathogens generally are found on poultry than on other raw animal foods. Therefore, a higher temperature, in combination with the appropriate time is needed to cook these products. To kill microorganisms, food must be cooked to a minimum temperature that must be achieved and maintained in all parts of each piece of meat. Heating a large roast too quickly with a high oven temperature, for example, may char or dry the outside, creating a layer of insulation that shields the inside from efficient heat penetration. To kill all pathogens in food, cooking must bring all parts of the food up to the required temperatures for the correct length of time.

760-1333.11 The rapid increase in food temperature resulting from microwave heating does not provide the same cumulative time and temperature relationship necessary for the destruction of microorganisms as do conventional cooking methods. In order to achieve comparable lethality, the food must attain a temperature of 165^oF (74^oC) in all parts of the food. Since cold spots may exist in food cooking in a microwave oven, it is critical to measure the food temperature at multiple sites when the food is removed from the oven and then allow the food to stand covered for two minutes post microwave heating to allow thermal equalization and exposure. Although some microwave ovens are designed and engineered to deliver energy more evenly to the food than others, the important factor is to measure and ensure that the final temperature reaches 165^oF (74^oC) throughout the food.

760-1333.14 Close attention must be paid to control of biological hazards when a food establishment cooks raw animal foods using a process in which the food is partially cooked then cooled with the intention of fully cooking the food at a later date or time. This section of the sanitary code requires that establishments wishing to use a non-continuous process for the cooking of raw animal foods establish and follow a written plan that ensures each stage of the process is completed within time and temperature parameters that adequately prevent pathogen survival and growth. This code section also requires that establishments take special precautions to ensure that raw animal foods that have only been initially heated to temperatures that are not lethal to the pathogens of concern are clearly identified so that they will not be inadvertently sold or served to the consumer in a partially cooked state.

To ensure the food does not dwell for extended periods within temperature ranges that favor pathogen growth, limits are established on the time permitted to initially heat the food (initial “come-up” time) and the time permitted to cool the product to temperatures that are safe for refrigerated storage. Together, these limits should prevent food from remaining at temperatures at which pathogen growth to harmful levels may occur.

The maximum one hour time limit for the initial heating stage was established based on estimates from predictive microbial modeling. It is intended to limit the cumulative growth of Clostridium perfringens that may occur during the come-up time and the subsequent cooling of the product. Unless properly controlled, processes in which animal foods are heated to sub-lethal temperatures and times and then cooled may create an environment for the growth of Clostridium perfringens, Clostridium botulinum and other spore forming, toxigenic bacteria.

The product temperature achieved during the initial heating process may not be sufficient to destroy vegetative cells of Clostridium botulinum, Clostridium perfringens, and Bacillus cereus, if present. The concern is the generation of a large number of vegetative cells of Clostridium perfringens and/or Clostridium botulinum before the final cooking stage. For Clostridium botulinum, if enough vegetative cells are produced, toxigenesis can occur in the product before the product is fully cooked. The toxin is not destroyed at the minimum required cooking temperatures. For Clostridium perfringens, if a large number of vegetative cells are consumed, illness can result. In either case a high number of vegetative cells may challenge the lethality step of the ultimate cooking process to the extent that it will be unable to completely eliminate all of these vegetative cells. The cumulative growth of these bacterial pathogens must be taken into account during both the initial heating and cooling steps. The hazard may be compounded with an extended initial “come-up” time and/or a prolonged cooling stage. Hence the degree of hazard may be dependent upon the ultimate effect of the initial heating and cooling, as well as the final cooking step.

A full and adequate cook during the final cooking step is of critical importance to ensure destruction of any pathogens that may have survived and proliferated during any initial heating and cooling stages of the non-continuous cooking process. Section 760-1333.14 requires that animal foods cooked by a non-continuous cooking process achieve a minimum final cook temperature that heats all parts of the food to a temperature of at least 165^oF (74^oC) for 15 seconds to ensure the destruction of vegetative microbial pathogens, no matter the size of the product. This provides for an additional safeguard beyond the minimum cooking temperature required for many types of animal foods that are cooked using a continuous, uninterrupted process. This requirement also precludes serving animal foods that have undergone non-continuous cooking in an undercooked or raw state.

Section 760-1333.14 also requires that an establishment using non-continuous cooking processes establish procedures for identifying foods that have only been partially cooked and cooled. This is necessary to ensure these foods are not mistaken by food workers for foods that have been fully cooked and therefore ready-to-eat without a full cook. Partially cooked foods may appear to be fully cooked.

Requiring that food establishments obtain prior approval by the regulatory authority before employing non-continuous cooking processes will help to ensure that the establishment has the proper procedures in place, as well as the necessary facilities and capacity to monitor the appropriate cooling, cooking, separation and product identification of the foods in accordance with the requirements.

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F015 - PROPER REHEATING PROCEDURES FOR HOT HOLDING

760-1333.6 When food is held, cooled, and reheated in a food establishment, there is an increased risk from contamination caused by personnel, equipment, procedures, or other factors. If food is held at improper temperatures for enough time, pathogens have the opportunity to multiply to dangerous numbers. Proper reheating provides a major degree of assurance that pathogens will be eliminated. It is especially effective in reducing the numbers of Clostridium perfringens that may grow in meat, poultry, or gravy if these products were improperly cooled. Vegetative cells of C. perfringens can cause foodborne illness when they grow to high numbers. Highly resistant C. perfringens spores will survive cooking and hot holding. If food is abused by being held at improper temperatures or improperly cooled, spores can germinate to become rapidly multiplying vegetative cells.

Although proper reheating will kill most organisms of concern, some toxins such as that produced by Staphylococcus aureus, cannot be inactivated through reheating of the food. It is imperative that food contamination be minimized to avoid this risk. The potential for growth of pathogenic bacteria is greater in reheated cooked foods than in raw foods. This is because spoilage bacteria, which inhibit the growth of pathogens by competition on raw product, are killed during cooking. Subsequent recontamination will allow pathogens to grow without competition if temperature abuse occurs.

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F016 - PROPER COOLING TIME AND TEMPERATURES

760-1333.5 Safe cooling requires removing heat from food quickly enough to prevent microbial growth. Excessive time for cooling of time/temperature control for safety foods has been consistently identified as one of the leading contributing factors to foodborne illness. During slow cooling, time/temperature control for safety foods are subject to the growth of a variety of pathogenic microorganisms. A longer time near ideal bacterial incubation temperatures, 70^oF - 125^oF (21^oC - 52^oC), is to be avoided. If the food is not cooled in accordance with the sanitary code requirement, pathogens may grow to sufficient numbers to cause foodborne illness.

The sanitary code provision for cooling requires cooling from 140ºF to 41°F in 6 hours, with cooling from 140ºF to 70°F in 2 hours. The 6-hour cooling parameter, with an initial 2-hour rapid cool, allows for greater flexibility in meeting code requirements. The initial 2-hour cool is a critical element of this cooling process. An example of proper cooling might involve cooling from 140ºF to 70ºF in 1 hour, in which case 5 hours remain for cooling from 70ºF to 41ºF. Conversely, if cooling from 140ºF to 41°F is achieved in 6 hours, but the initial cooling to 70ºF took 3 hours, the food safety hazards may not be adequately controlled.

If the cooking step prior to cooling is adequate and no recontamination occurs, all but the spore-forming organisms such as Clostridium perfringens or Bacillus cereus should be killed or inactivated. However, under substandard sanitary conditions, other pathogens such as Salmonella or Listeria monocytogenes may be reintroduced. Thus, cooling requirements are based on growth characteristics of organisms that may survive or be a post-cook contaminant and grow rapidly under temperature abuse conditions.

760-1334.1 Requiring that properly cooled time/temperature control for safety foods be stored in shallow pans/small quantities provides a monitoring point for food workers and sanitarians to ensure that a rapid cooling procedure has been followed.

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F017 - PROPER HOT AND COLD HOLDING TEMPERATURES

760-1319.10 Smoked fish products have been associated with illness outbreaks caused by Clostridium botulinum, type E. The spores of C. botulinum are very common in nature. C. botulinum, type E is the most common form found in fresh water and marine environments, and can be found in the gills and viscera of fin fish, crabs, and shellfish. The minimum temperature for growth of C. botulinum, type E and toxin formation is 38°F. Maintaining smoked fish at 38^oF or less prevents the growth of the bacterium and formation of toxin.

760-1332.3 Bacterial growth and/or toxin production can occur if time/temperature control for safety food remains in the temperature Danger Zone of 41^oF to 140^oF (5^oC to 60^oC) too long. Up to a point, the rate of growth increases with an increase in temperature within this zone. Beyond the upper limit of the optimal temperature range for a particular organism, the rate of growth decreases. Operations requiring heating or cooling of food should be performed as rapidly as possible to avoid the possibility of bacterial growth.

760-1333.3 Cooking, to be effective in eliminating pathogens, must be adjusted to a number of factors. These include the anticipated level of pathogenic bacteria in the raw product, the initial temperature of the food, and the food's bulk which affects the time to achieve the needed internal product temperature.

Greater numbers and varieties of pathogens generally are found on poultry than on other raw animal foods. Therefore, a higher temperature, in combination with the appropriate time is needed to cook these products. To kill microorganisms, food must be cooked to a minimum temperature that must be achieved and maintained in all parts of each piece of meat. Heating whole frozen poultry or poultry breasts too quickly with a high oven temperature, for example, may not permit heat to fully penetrate to the interior of the meat. To kill all pathogens in food, cooking must bring all parts of the food up to the required temperatures for the correct length of time. Ensuring that large pieces of poultry are completely thawed prior to cooking reduces the possibility that pathogenic microorganisms will not be killed by thorough cooking to 165^oF in all parts of the food.

760-1333.4 If the ingredients used in the production of cold potentially hazardous foods are pre-chilled, the potential for time-temperature abuse during preparation is reduced, and the potential increase in pathogenic bacterial growth is therefore substantially reduced.

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F018 - PROPER DATE MARKING PROCEDURES USED

760-1330.4.a Refrigeration prevents food from becoming a hazard by significantly slowing the growth of most microbes. The growth of some bacteria, such as Listeria monocytogenes, is significantly slowed but not stopped by refrigeration. Over a period of time, this and similar organisms may increase their risk to public health in ready-to-eat foods.

Based on a predictive growth curve modeling program for Listeria monocytogenes, ready-to-eat, time/temperature control for safety food may be kept at 41^oF (5^oC) a total of 7 days. Food which is prepared and held, or prepared, frozen, and thawed must be controlled by date marking to ensure its safety based on the total amount of time it was held at refrigeration temperature, and the opportunity for Listeria monocytogenes to multiply, before freezing and after thawing. Time/temperature control for safety refrigerated foods must be consumed, sold or discarded by the expiration date.

Date marking is the mechanism by which the sanitary code requires active managerial control of the temperature and time combinations for cold holding. Food establishments must implement a system of identifying the date or day by which the food must be consumed, sold, or discarded. Date marking requirements apply to containers of processed food that have been opened, and to food prepared by a food establishment, in both cases if held for more than 24 hours, and while the food is under the control of the food establishment. This provision applies to both bulk and display containers.

Certain refrigerated time/temperature control for safety foods are exempted from date marking due to the presence of several factors that control the growth of Listeria monocytogenes. These factors may be naturally occurring or added during the manufacturing process, and include organic acids, preservatives, competing microorganisms, pH, water activity or salt concentration.

760-1330.4.b It is not the intent of this code section to give a product an extended shelf life beyond that intended by the manufacturer. Manufacturers assign a date to products for various reasons, and spoilage may or may not occur before pathogen growth renders the product unsafe. Most, but not all, sell-by or use-by dates are voluntarily placed on food packages.

Although most use-by and sell-by dates are not enforceable by regulators, the manufacturer's use-by date is its recommendation for using the product while its quality is at its best. Although it is a guide for quality, it could be based on food safety reasons. It is recommended that food establishments consider the manufacturer’s information as good guidance to follow to maintain the quality (taste, smell, and appearance) and salability of the product. If the product becomes inferior quality-wise due to time in storage, it is possible that safety concerns are not far behind.

760-1330.4.c This code section provides general parameters for a date marking system that helps food establishments manage refrigerated storage time of applicable foods. A date marking system may be used which places information on the food, such as on an overwrap or on the food container, which identifies the first day of preparation, or alternatively, may identify the last day that the food may be sold or consumed on the premises. A date marking system may use calendar dates, days of the week, color-coded marks, or other effective means, provided the system is disclosed to the Department upon request, during inspections.

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F019 - TIME AS A PUBLIC HEALTH CONTROL - PROCEDURES AND RECORDS

760-1330.6 Food kept without temperature control allows product to warm or cool as it equilibrates with the environment. Each temperature scenario incurs different risks in regard to the type of foodborne pathogens able to grow and the rate of growth likely to occur. For both cooling and warming conditions, growth depends on the amount of time the food spends in an optimum growth temperature range during its equilibration with its surroundings. Several factors influence the rate of temperature change in a food, such as the type of food, thickness of the food, and temperature differential between the food and its surroundings. When evaluating the safety of a 4-hour limit for food with no temperature control, products and environmental parameters must be selected to create a worst-case scenario for pathogen growth and possible toxin production.

When a food is removed from refrigerated storage and begins to warm to room temperature, Listeria monocytogenes is a primary organism of concern. Even while food is held at refrigeration temperatures, the growth potential of L. monocytogenes warrants concern for time/temperature control for safety foods that are ready-to-eat. Salmonella is also a concern, especially with products containing eggs. However L. monocytogenes grows more rapidly than Salmonella at refrigeration and room temperatures. By ensuring minimal Listeria growth in food, the threat from Salmonella would be negligible. Warming conditions will allow food to remain exposed to temperatures that allow B. cereus to produce emetic toxin. However the 4-hour time constraint in the sanitary code is sufficient to prevent any toxin formation.

It is important to note that time/temperature control for safety foods held without cold holding temperature control for a period of 4 hours do not have any temperature control or monitoring. These foods can reach any temperature when held at ambient air temperatures as long as they are discarded or consumed within the four hours.

The second scenario for food without temperature control exists when food is cooked according to sanitary code requirements, then kept at room temperature for 4 hours before discarding. Foodborne pathogens of concern for an uncontrolled temperature scenario are spore formers including Clostridium perfringens and Bacillus cereus. Food cooked according to sanitary code guidelines should be free of vegetative cells. However, the heat requirements are not sufficient to kill spores of C. perfringens or B. cereus and may actually serve as a heat shock that activates the spores. B. cereus is found commonly in outbreaks attributed to inadequate hot holding of starchy foods like rice, and has been isolated in a multitude of food products. C. perfringens is found commonly in outbreaks attributed to inadequate hot holding of beef and poultry. Despite the prevalence of both spores in nature, C. perfringens cases are estimated to be more numerous than B. cereus cases by a factor of 10.

B. cereus can produce emetic toxin in food, and the optimum temperature for the production of toxin is between 77°F and 86°F. However, the time needed to produce the toxin is longer than the time the food will be exposed to any temperature range with a 4-hour holding limit. Both C. perfringens and B. cereus produce enterotoxin inside the intestine of the infected host if substantial numbers of vegetative cells are present in the food.

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CONSUMER ADVISORY

F020 - CONSUMER ADVISORY PROVIDED FOR RAW AND UNDERCOOKED FOODS

760-1333.9 At issue is the role of government agencies, the regulated industry, and others in providing notice to consumers that animal-derived foods that are not subjected to adequate heat treatment pose a risk because they may contain biological agents that cause foodborne disease. Delivering a balanced message that communicates fairly to all consumers and, where epidemiologically supported, attempts to place risk in perspective based on the consumer’s health status and the food being consumed is part of the challenge. Notification of risk must be achieved via a meaningful message and in a manner that is likely to affect behavior. The Department developed standards based on recommended language in the FDA Food Code that requires written notification containing both disclosure that the food is raw, undercooked or may contain undercooked ingredients, and a reminder that consuming such food increases the risk of foodborne disease.

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HIGHLY SUSCEPTIBLE POPULATIONS

F021 - PASTEURIZED FOODS USED, PROHIBITED FOODS NOT OFFERED

760-1313 Highly susceptible population means persons who are more likely than other people in the general population to experience foodborne disease because they are immunocompromised or elderly and in a facility that provides health care or assisted living services, such as a hospital or nursing home, or are obtaining food at a facility that provides nutritional or socialization services such as a senior center; or preschool age children in a facility that provides custodial care, such as a day care center. Members of this population have increased vulnerability to foodborne illness, thus certain foods may not be offered and certain procedures may not be utilized in food establishments that serve this population exclusively. These additional restrictions further protect highly susceptible populations from potential to experience a foodborne illness.

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CHEMICAL

F022 - FOOD ADDITIVES - APPROVED AND PROPERLY USED

760-1315.f It is imperative for safety that food supplies come from sources that are in compliance with laws regarding chemical additives and contaminants.

Food additives are substances which, by their intended use, become components of food, either directly or indirectly, and are strictly regulated. In excessive amounts or as a result of unapproved application, additives may be harmful to the consumer. Unintentional contaminants or residues also find their way into the food supply. The tolerances or safe limits designated for these chemicals are determined by risk assessment evaluations based on toxicity studies and consumption estimates.

Food and color additives must be used in compliance with a federal food, or color additive regulation, an effective food-contact notification, or a threshold of regulation exemption. Such regulations, notifications, and exemptions are generally composed of three parts: the identity of the substance, specifications including purity or physical properties, and limitations on the conditions of use. In order for a food, or color additive use to be in compliance, the use must comply with all three criteria.

Use of unapproved additives, or the use of approved additives in amounts exceeding those allowed by food additive regulations could result in foodborne illness, including allergic reactions. For example, many adverse reactions have occurred because of the indiscriminate use of sulfites to retard "browning" of fruits and vegetables or to cause ground meat to look "redder" or fresher.

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F023 - CHEMICALS AND TOXIC MATERIALS STORED AND USED PROPERLY

760-1337.1 The presence in the food establishment of poisonous or toxic materials that are not required for the maintenance and operation of the establishment represents an unnecessary risk to both employees and consumers.

Preserving food safety depends in part on the appropriate and proper storage and use of poisonous or toxic materials that are necessary to the maintenance and operation of a food establishment. Even those that are necessary can pose a hazard if they are used in a manner that contradicts the intended use of the material as described by the manufacturer on the material's label. If additional poisonous or toxic materials are present, there is an unwarranted increased potential for contamination due to improper storage (e.g., overhead spillage that could result in the contamination of food, food contact surfaces, or food equipment) or inappropriate application.

If a chemical wash, boiler water additive, or drying agent used is not made up of components that are approved as food additives or generally recognized as safe, illness may result. This could be due to residues that may remain from the use of compounds such as unrecognized drying agents. This is why only those chemicals that are listed in the Code of Federal Regulations (CFR) can be used. Boiler water additives that may be safely used in the preparation of steam that may contact food, and their conditions of use, are identified in 21 CFR 173.310 Boiler Water Additives.

760-1337.2 Failure to properly use poisonous or toxic materials can be dangerous. Many poisonous or toxic materials have general use directions on their label. Failure to follow the stated instructions could result in injury to employees and consumers through direct contact or the contamination of food.

Particular precautions must be taken during the application of poisonous or toxic materials to prevent the contamination of food and other food-contact surfaces. Residues of certain materials are not discernible to the naked eye and present an additional risk to the employee and consumer.

760-1337.3 The accidental contamination of food or food-contact surfaces can cause serious illness. Prominent and distinct labeling helps ensure that poisonous and toxic materials including personal care items are properly used. It is common practice in food establishments to purchase many poisonous or toxic materials including cleaners and sanitizers in bulk containers. Working containers are frequently used to convey these materials to areas where they will be used, resulting in working containers being stored in different locations in the establishment. Identification of these containers with the common name of the material helps prevent the dangerous misuse of the contents. Containers previously used to store poisonous or toxic materials may not be used for food, since they may contain toxic residues or be constructed of material not approved as a food contact surface.

760-1337.4 Separation of poisonous and toxic materials in accordance with the requirements of this section ensures that food, equipment, utensils, linens, and single-service and single-use articles are properly protected from contamination. For example, the storage of these types of materials directly above or adjacent to food could result in contamination of the food from spillage.

760-1337.5 Chemical sanitizers are included with poisonous or toxic materials because they may be toxic if not used in accordance with requirements listed in the Code of Federal Regulations (CFR). Large concentrations of sanitizer in excess of the CFR requirements can be harmful because residues of the materials remain.

Phenolic compounds are among the oldest known sanitizing and disinfectant agents and are commonly used in some household disinfectants. They are inappropriate for use on food contact surfaces, however, due to their toxicity to humans.

760-1356.2 Open bait stations may result in the spillage of the poison being used. Also, it is easier for pests to transport the potentially toxic bait throughout the establishment. Consequently, the bait may end up on food-contact surfaces and ultimately in the food being prepared or served.

760-1356.3 The use of tracking powder pesticides presents the potential for the powder to be dispersed throughout the establishment. Consequently, the powder could directly or indirectly contaminate food being prepared. This contamination could adversely affect both the safety of the food and, therefore, tracking powder pesticides are not allowed.

760-1356.4 The use of non-toxic tracking powders presents the potential for the powder to be dispersed throughout the establishment. Consequently, the powder could directly or indirectly contaminate food being prepared. This contamination could adversely affect both the safety and quality of the food and, therefore, tracking powder pesticides are not allowed.

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F024 - PERSONAL MEDICATIONS PROPERLY STORED

760-1337.7 Medicines that are not necessary for the health of employees present an unjustified risk to the health of other employees and consumers due to misuse and/or improper storage. There are circumstances that require employees or children in a day care center, for example, to have personal medications on hand in the establishment. To prevent misuse, personal medications must be labeled and stored in accordance with the requirements stated for poisonous or toxic materials. Proper labeling and storage of medicines ensures that they are not accidentally misused or otherwise contaminate food or food-contact surfaces. First aid supplies for employee use must be identified and stored in accordance with the requirements of the sanitary code in order to preclude the accidental contamination of food, food equipment, and other food-contact surfaces.

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CONFORMANCE WITH APPROVED PROCEDURES

F025 - COMPLIANCE WITH VARIANCE PROCEDURES

760-1315.d Reduced oxygen packaging (ROP) encompasses a large variety of packaging methods where the internal environment of the package contains less than the normal ambient oxygen level (typically 21% at sea level), including vacuum packaging (VP), modified atmosphere packaging (MAP), controlled atmosphere packaging (CAP), cook chill processing (CC), and sous vide (SV). Using ROP methods in food establishments has the advantage of providing extended shelf life to many foods because it inhibits spoilage organisms that are typically aerobic.

This state of reduced oxygen is achieved in different ways. Oxygen can be withdrawn from the package (VP) with or without having another gas such as nitrogen or carbon dioxide replacing it (MAP). [MAP is not commonly used in food establishments.] Fresh produce and raw meat or poultry continue to respire and use oxygen after they are packaged. Bacterial activity also plays a role here. The process of cooking drives off oxygen (the bubbling is oxygen gas coming off) and leaves a reduced oxygen level in the food, thus, microenvironments of reduced oxygen are possible.

Most foodborne pathogens are anaerobes or facultative anaerobes able to multiply under either aerobic or anaerobic conditions, therefore special controls are necessary to control their growth. Refrigerated storage temperatures of 41°F (5°C) may be adequate to prevent growth and/or toxin production of some pathogenic microorganisms but C. botulinum and L. monocytogenes are able to multiply well below 41°F (5°C). For this reason, C. botulinum and L. monocytogenes become the pathogens of concern for ROP. Controlling their growth will control the growth of other foodborne pathogens as well.

When a food establishment intends to use ROP technology, the operator must submit an application for a variance according to the sanitary code section 760-1309, providing evidence that the ROP methodology intended for use is safe. A Hazard Analysis Critical Control Point (HACCP) plan is essential when using ROP processing procedures. C. botulinum and L. monocytogenes are potential hazards which must be controlled in most foods. Critical control points, critical limits, monitoring, record keeping, corrective actions, and verification procedures will vary based on the type of food and type of ROP technology used.

Unfrozen raw fish and other seafood are specifically excluded from ROP because of these products’ natural association with C. botulinum type E which grows at or above 37-38^oF (3^oC). Fish and seafood that are frozen before, during and after the ROP packaging process are allowed.

760-1315.j Specific food processes that require a variance have historically resulted in more foodborne illness than standard processes. They present a significant health risk if not conducted under strict operational procedures. These types of operations may require the person in charge and food employees to use specialized equipment and demonstrate specific competencies. The variance requirement is designed to ensure that the proposed method of operation is carried out safely.

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ADDITIONAL IMMINENT HEALTH HAZARDS THAT MAY CONTRIBUTE TO FOODBORNE ILLNESS

F026 - RUNNING WATER PROVIDED WHERE REQUIRED

760-1350.13 Availability of sufficient water is a basic requirement for proper sanitation within a food establishment. An insufficient supply of safe water will prevent the proper cleaning of items such as equipment and utensils and of food employees' hands.

Hot water required for washing items such as equipment, utensils and employees' hands must be available in sufficient quantities to meet demand during peak water usage periods. Booster heaters for ware washing equipment that uses hot water for sanitizing are designed to raise the temperature of hot water to a level that ensures sanitization. If the volume of water reaching the booster heater is not sufficient or hot enough, the required temperature for sanitization cannot be reached. Manual washing of food equipment and utensils is most effective when hot water is used. Unless utensils are clean to sight and touch, they cannot be effectively sanitized.

Inadequate water pressure could lead to situations that place the public health at risk. For example, inadequate pressure could result in improper handwashing or equipment operation. Sufficient water pressure ensures that equipment such as mechanical ware washers operate according to manufacturer's specifications.

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F027 - SEWAGE AND WASTEWATER PROPERLY DISPOSED

760-1351 Improper disposal of waste provides potential for contamination of food, utensils, and equipment and, therefore, may cause serious illness or disease outbreaks. Proper removal is required to prevent contamination of ground surfaces and water supplies, or creation of other insanitary conditions that may attract insects and other vermin.

Many diseases can be transmitted from one person to another through fecal contamination of food and water. This transmission can be indirect. Proper disposal of human wastes greatly reduces the risk of fecal contamination. This sanitary code provision is intended to ensure that wastes will not contaminate ground surfaces or water supplies, pollute surface waters, be accessible to children or pets, or allow rodents or insects to serve as vectors of disease from this source.

Liquid food wastes and rainwater can provide a source of bacterial contamination and support populations of pests. Proper storage and disposal of wastes and drainage of rainwater eliminate these conditions.

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SAFE WATER AND ICE

F028 - WATER AND ICE FROM APPROVED SOURCES

760-1335.3 This code section is intended to protect both machine dispensed and manually dispensed, unpackaged ice from contamination. Barriers need to be provided in mechanical ice dispensers so that only the ice intended to be dispensed is released when the machine's mechanism is activated. Recessed ice machine components and self-closing doors prevent contamination of machine ports by people, dust, insects, or rodents. If the equipment components become contaminated, the ice itself will be exposed to possible contamination. A direct opening into ice dispensers allows dust, vermin, and other contaminants access to the ice. Manually dispensed drink ice is a ready-to-eat food and may not be contacted with bare hands in order to prevent disease transmission.

760-1334.6 Freezing does not invariably kill microorganisms; on the contrary, it may preserve them. Therefore, ice that comes into contact with food to cool it or that is used directly for consumption must be as safe as drinking water that is periodically tested and approved for consumption.

Ice that has been in contact with unsanitized surfaces or raw animal foods may contain pathogens and other contaminants. For example, ice used to store or display fish or packaged foods could become contaminated with microbes present on the fish or packaging. If this ice is then used as a food ingredient, it could contaminate the final product.

760-1350.1 Water, unless it comes from a safe supply, may serve as a source of contamination for food, equipment, utensils, and hands. The major concern is that water may become a vehicle for transmission of disease organisms. Water can also become contaminated with natural or man-made chemicals. Therefore, for the protection of consumers and employees, water must be obtained from a source regulated by law and must be used, transported, and dispensed in a sanitary manner.

Bacteriological and chemical standards have been developed for public drinking water supplies to protect public health. All drinking water supplies must meet standards required by law.

Inadequate water systems may serve as vehicles for contamination of food or food contact surfaces. This code section is intended to ensure that sufficient volumes of water are provided from supplies shown to be safe, through a distribution system which is protected.

Suffolk County Government

Edward P. Romaine, County Executive