Abstract. This capstone represents a proposal for the implementation of a standardized

Transcription

1 Abstract This capstone represents a proposal for the implementation of a standardized program for food inspections and food inspection training. Two research questions and associated hypotheses are presented to justify and demonstrate the practical application in a health department setting. Research questions investigated in this study are (1) Did the population of sanitarians studied cite more non-cdc or CDC foodborne illness risk factors during their inspection and (2) Did the number of violations increase as the risk class for the establishments increase. A paired t-test was used for the verification of the first hypothesis corresponding to the first research question, and ANOVA statistical analysis was used to analyze the data for the second hypothesis corresponding to the second research question. The results for the paired t-test had a P-value <.05, confirming the first hypothesis that more non-cdc foodborne illness risk factors were cited than the CDC foodborne illness risk factors. The results for the ANOVA statistical analysis indicated that the data was significant with a P-value <.05. It was observed that the mean number of violations by risk class did not increase when compared to risk class 1 to risk class 2. The mean value for risk class 3 was found to be greater than risk classes 1 and 2 indicating a direct relation between the risk factors and risk classification. A higher mean number of violations were observed in risk class 4 establishments. This does not affirm the second hypothesis that the number of violations cited increased as the risk class for the establishments increased. Further studies are needed to verify why the number of violations went down. 1

2 Introduction The Cincinnati Health Department (CHD) is currently enrolled in the Food and Drug Administration s (FDA) Voluntary National Retail Food Regulatory Program Standards (2007). The department has conducted an assessment to determine where the organization currently stands in regards to the FDA s eight program standards. The proposed project is to develop a policy/guidance document for the City of Cincinnati Health Department that promotes uniformity in the way Sanitarians conduct inspections in the food protection program. In Ohio there is a requirement for personnel who serve as sanitarians and practice within local or state health agencies be registered with the state. Initially the person is registered as a Sanitarian-in-Training (SIT) that is supervised by a Registered Sanitarian (RS). Once the SIT passes the Registered Sanitarian exam and completes one or two years of field experience, they get certified as a Registered Sanitarian. SITs requiring one year field experience must possess an educational degree at a Master level or above or had an internship in environmental health. For the purpose of this study, both the Sanitarian-in-Training and Registered Sanitarian will be referred to as a sanitarian. The policy/guidance document will contain the program description, the work experience requirements, required coursework and field training. Part of the coursework includes the completion of a final project that the sanitarian will be required to successfully complete in order to become standardized. After the successful completion of the program the sanitarian will be standardized as Cincinnati Health Department Food Safety personnel. The sanitarian will be trained to consistently utilize the Ohio Uniform Food Safety Code when conducting risk assessments for the foods served or offered for sale at 2

3 Food Service Operation s (FSO) and a Retail Food Establishment s (RFE). During the food inspection training, the candidates will learn how to apply the Centers for Disease Control and Prevention (CDC) foodborne illness risk factors. These CDC foodborne illness risk factors are found in the report of the FDA Retail Food Program Database of Foodborne Illness Risk Factors (2000), in the section on food flow through an establishment. The CDC foodborne illness risk factors are; food from unsafe sources, improper holding/time and temperature, inadequate cooking, poor personal hygiene and contaminated equipment/prevention of contamination. The sanitarian will also observe and verify the Person in Charge s (PIC) demonstration of knowledge in food safety, their duties and responsibilities and also verify they have certification in food safety. Within the framework of the hypotheses, the goals of this proposal will be to determine (1) if the of CDC foodborne illness risk factors are cited less than non-cdc foodborne illness risk factors prior to the implementation of the food safety standardization program; and (2) do the CDC and non-cdc foodborne illness risk factors cited increase as the risk classification of the establishment increase. The working hypotheses for this proposal are (1) The number of CDC foodborne illness risk factors are less likely to be cited than non-cdc food borne illness risk factors before the implementation of the food safety standardization program; and (2) The number of CDC and non-cdc foodborne illness risk factors cited increase as the risk class increases. Staff and funds available to the CHD Environmental Health Service s Food Safety Program are limited to the FSO and RFE license fees. The Ohio Department of Health has classified FSO and RFE into four risk categories in the Ohio Revised Code 3

4 (ORC) 3717 and Ohio Administrative Code (OAC) Risk level 1 poses potential risk to the public in terms of sanitation, food labeling, sources of food, storage practices, or expiration dates. Examples of risk level I activities include, but are not limited to, an operation that offers for sale or sells: coffee, fountain drinks, pre-packaged refrigerated foods and baby food and formula. Risk level 2 poses a higher potential risk to the public than risk level 1 because of hand contact or employee health concerns but minimal possibility of pathogenic growth exists. Examples of risk level 2 activities include, but are not limited to: holding time/temperature control for safety (TCS) foods at the same temperature at which it was received and heating individually packaged and commercially processed TCS foods for immediate service. Risk level 3 poses a higher potential risk to the public than risk level 2 because of the following concerns: proper cooking temperatures, proper cooling procedures, proper holding temperatures, contamination issues or improper heat treatment in association with longer holding times before consumption, or processing a raw food product requiring bacterial load reduction procedures in order to sell it as ready-to-eat. Examples of risk level 3 activities include, but are not limited to: handling raw meat products, cutting and slicing lunchmeats, cooking individual portions of TCS foods for service. Risk level 4 poses a higher potential risk to the public than risk level 3 because of concerns associated with: handling or preparing food using a procedure with several preparation steps that include reheating of a product or ingredient of a product where multiple temperature controls are needed to preclude bacterial growth; offering as ready-to-eat a raw potentially hazardous meat, poultry product, fish, or shellfish or a food with these raw potentially hazardous items as ingredients; using freezing as a means to achieve parasite destruction; serving a primarily 4

5 high risk clientele including immuno-compromised or elderly individuals in a facility that provides either health care or assisted living; or using time in lieu of temperature as a public health control for potentially hazardous food or performs a food handling process that is not addressed, deviates, or otherwise requires a variance for the process. The more complex the food preparation or the food offered for sale, the higher the risk class is and opportunity for a foodborne illness. The higher the risk class the greater is the license fee. The greater the risks, the more time a sanitarian will need to spend in the facility conducting the inspection and educating the person in charge. The FDA standardization program will help leverage the time a sanitarian will spend in an FSO/RFE establishment focusing first on the CDC foodborne illness risk factors. The sanitarian will also address any structural issues with the establishment, as their time allows. 5

6 Review of the Literature The FDA Report on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice, Restaurant, and Retail Food Store Facility Type (2004) states; The CDC foodborne illness risk factors; food from an unsafe source, inadequate cooking of time/temperature control for safety (TCS) food, inadequate hot/cold holding of TCS food, employee hygiene and contamination are the most common causes of foodborne illnesses. This FDA report identified the risk factors that were in compliance or not in compliance during the inspections. The report incorporated details from inspections made at over 900 facilities across the country by 21 FDA Standardized Food Safety Specialists. The results from the inspections were classified into nine types of establishments; hospitals, nursing homes, elementary schools, fast food, full service, produce, deli, seafood, meat and poultry. These establishments were further divided into two groups: group one facilities were those facilities where someone on the premises was certified in food protection during the time of inspection, while group two facilities did not have a person certified in food protection on site during the inspection. The FDA staff standardization process includes computer classroom time and field work. The classroom computer work component includes a series of courses that are taken online at the FDA Office of Regulatory Affairs University (ORAU) web site. Once this is successfully completed, the candidate would accompany a FDA Regional Food Safety Specialist to conduct a joint field inspection. Based on the results, the trainee might either be released or allowed to continue with joint inspection until they understood the risks the operations present in the handling and preparation of food sold or served at the facility. This is the model that the CHD plans to follow in standardizing the 6

7 food protection staff. The training and education of the CHD staff will provide a tool to recognize the risk factors that can impact the food while it flows through the operation --- from the time the food is received until the food is packaged and/or served to the customer. Assessment of risk factors of food items at every step of its flow through a food establishment is critical to reducing the number of CDC foodborne illness risk factors. There will be fewer opportunities for foodborne illnesses to occur when risk factors are reduced or eliminated at an establishment. A foodborne illness outbreak can have a negative impact at the local and national level as exemplified in an article by Martin (2009, June 26) on the beef recall and the article by Schmidt (2009, April 27), on the peanut butter recall. World Health Organization (2007, March) reports an estimated 76 million people become ill with a foodborne illness; 325,000 hospitalizations and 5,000 deaths each year in the United States. This results in a tremendous burden on the economy, with the loss of workers time away from their work for medical attention, medical costs, hospitalization and possible death. In addition, not to mention the loss of income that may be incurred by a food service provider or manufacturer. A foodborne illness is something that can be easily avoided. A knowledgeable sanitarian, who applies the CDC five foodborne illness risk factors to the flow of food in the operation, should be able to help reduce the number of risk factors noted during an inspection. It has been reported by the FDA (2004) that with the reduction in the number of foodborne illness risk factors the opportunity for foodborne illnesses is also reduced. Woteki and Kineman (2003) article state that the laws, regulations and organizations comprising the food safety system frequently lag behind current scientific 7

8 knowledge of the risks posed by foodborne pathogens. Future systematic changes to enhance food safety will require better understanding of risks associated with specific pathogens occurring in the food supply and the costs and benefits of implementing mitigation strategies. They are also critical of government agencies for lagging behind in understanding the risks of food items that are imported into the United States. The current laws, regulations and inspection protocols have failed to keep pace with the timely analysis of imported food. The evidence above provides support to the urgent need for the federal government to catch up with the imported foods analyses, overhauling of the current laws and regulations that govern the food system and a critical evaluation of the new food preparation techniques in the United States. The House of Representatives Bill 2749, Food Safety Enhancement Act updates food safety in the United States and recommends the power of recalls be given to federal agencies. The United States Department of Agriculture (USDA) can only recommend that food processors and manufactures recall their product(s). The USDA can not initiate a food product recall because they were not given the authority to do so by the Congress. In his article Weise (2009, April 9) has cited an example of a food processor that refused to recall a food product recommended by the USDA. There is a need for all employees that work in food safety programs at the federal, state or a local health department level, to keep themselves current with the latest information and technology available to assess food safety. This can be accomplished by incorporating some form of continuing education. A trained sanitarian in the food safety program will have a better grip on current methods for eliminating pathogens. A thorough understanding of rules and regulations will provide the sanitarian a foundation on which to build their food safety knowledge that will require 8

9 them to take pertinent online courses. The agency that employ s the sanitarian will be responsible for providing access to the educational opportunities to the staff. Providing the opportunities for sanitarian s to attend advanced educational training is the first step in providing a well trained food protection staff. Written policies and procedures will also be needed for consistency in handling conditions by sanitarians during an inspection. Written policies and procedures will be easier to apply uniformly. The articles by Bryan (2000), Woteki & Kineman (2003) and Walls (2004) have focused on the importance of inspections, especially during a foodborne illness investigation (FBI). It is generally recommended that investigators should concentrate on contamination, survival, and/or propagation of the etiologic agents under suspicion. These recommendations were based on the process of conducting a step by step foodborne illness investigation. Thorough and detailed information to guide sanitarians conducting a foodborne illness investigation has been published by Martin (2009, June 26). Martin recommends that while conducting the investigation of a foodborne illness outbreak sanitarians must set aside their hypothesis on the cause of the outbreak and the suspect food item in the back of their mind. Since all investigations are done after the fact and sometimes the food item involved is gone or has been discarded, that is where the observational skills, knowledge and expertise of the sanitarian and the inspection history of the facility will help them in the investigation process. If the source of the outbreak is due to a personal hygiene issue, time/temperature abuse or contamination, well trained sanitarians will know where to target their investigation. Similarly, if the food item is involved in a recall, a Sanitarian would be narrowing down their suspicion at the food source and not necessarily the facility where it was served. Sometimes an 9

10 inspection of the site, interviewing of the staff and taking a meal history from the ill people is all that can be done. Occasionally, an inspector may enter a facility with a hypothesis on what might have caused an illness and leave with a different perspective and hypothesis. Susan Weber-Mosdorf (2006) states In our work on food safety, protection of the environment, and health and trade, we look closely at the determinants of health: in other words, the factors that cause disease and the strategies that can prevent ill-health. She is of the opinion that food protection and public health are coming to the fore front of the world stage as the world s economy grows. The demand for food comes from all over the world and the risks associated with those food items must be studied and understood by sanitarians. The above evidence also illustrates that when assessing risks, the nature of the hazard, the likelihood that an individual or population will be exposed to the hazard, and the likelihood that exposure will result in an adverse health effect, must be taken into consideration. Further, Weber-Mosdorf s (2006) report emphasizes that the regulatory community must have an understanding of the risks associated with the food items for sale or served in an establishment. Not knowing the hazards associated with the food in an establishment puts the public at risk and allows for possible harm to their customers. Walls (2004) states that the information developed during the risk assessment process can be used to help make risk management decisions to determine the most appropriate ways to prevent or minimize harm. During an inspection the sanitarian makes observations of the facility, food preparation practices, food storage and service techniques to evaluate the hazards associated with the food items. Based on those observations, recommendations are made for the facility concerning storage, preparation 10

11 and food handling to minimize the hazard associated with the food item to safe levels. If a sanitarian lacks the knowledge of the food items observed, they need to talk with the chef or person in charge to learn about them. Once the Sanitarian understands the characteristics and hazards of the food items, they will be in a better position to make recommendations to control the risks associated with them. Public health departments are responsible for ensuring the quality and safety of food provided by food facilities. Because of this responsibility, they need to adequately survey the risks imposed upon by consumers. Hoag, Porter, Uppala, & Dyjack (2007) report states that it is the local regulatory agency s responsibility to ensure safe food through risk assessment. Hoag et al. (2007) thoroughly reviewed the San Bernardino County food inspection program by placing the food establishments into different risk categories based upon the type of food that was prepared and served. The facilities with the lowest risk of causing a foodborne illness were in the lowest group. The complicated and high risk facilities were placed in the highest risk group. The number of times an establishment was inspected was based upon the risk of the food served or offered for sale. The riskier the operation, the more inspections the facility would receive. Hoag et al. (2007) concluded their study by finding that San Bernardino County has devised a risk-based food inspection model that can be used by agencies that desire evidence-based decision making with respect to allocation of resources. Agencies benefit through efficient use of inspection personnel, and the regulated community benefits through reduced fee schedules as a function of performance and inspection results. Assigning a level of risk to the facilities and determining the number of inspections for each type of facility are critical in protecting the health of the general public. 11

12 In the State of Ohio, per the Ohio Administrative Code (2009), FSO and RFE are charged license fees according to the risk they present to the public they serve. The higher the risk associated with the food served or offered for sale, the higher the risk class and the license fees that will be assessed. This risk based classification is based on the type of food sold and prepared by the FSO/RFE. The more complex the food preparation is in the operation the higher the risk class. The higher the risk class, the more inspections a sanitarian would perform at the facility which also corresponds to the amount of time spent in the facility. This would also designate how many inspections would be performed in a licensing year. Appropriate number of inspections per year, based on risk classification ensures that proper food storage, food handling and personal hygiene practices are being followed. In their article, Hoag et al. (2007) state assigning food facilities to risk categories supports prioritization of prevention and control measures. Moreover, the facilities with complex operations and the greatest potential to cause a foodborne illness would be where the sanitarian would be spending a majority of their time. The proper assessment of the risk by the sanitarian is what is critical to ensuring food safety. Each inspection requires a sanitarian to put in writing his/her observations as well as any violations noted during the inspection. The inspection report is signed by the sanitarian and the person in charge. This serves as the evidence that the facility was or was not in compliance with the current Ohio Uniform Food Safety Code rules and regulations. In his letter to the Journal of Environmental Health editor, Pallaske (2005) has emphasized that FSO Inspections aid the industry as well by: (a) Serving as an educational session on specific code requirements as they apply to an establishment and 12

13 its operation; (b) Conveying new food code safety information to establishment management and providing an opportunity for management to ask questions about general food safety matters: and (c) Providing a written report to the establishment s permit holder or person in charge so that the responsible person can bring the establishment into compliance with the code. A well trained sanitarian who conducts an inspection, utilizes the opportunity to learn more about the food prepared and/or served but also to educate the person in charge. The inspection of a food facility is only one aspect of the entire FSO/RFE inspection program. Many chefs today have attended culinary schools where they learn various preparation techniques for a variety of food items. During the inspection process, the sanitarian can learn from the chef about the food preparation processes. Based on what they learn they can conduct a risk assessment while discussing the food safety concerns with the chef. The opportunity for food sampling for laboratory analysis of the product, as it goes through the stages of preparation before it is served, is also encouraged. Food analysis helps provide the scientific evidence needed to demonstrate the safety of the food and the way it is prepared. Furthermore, education of the person in charge is essential to the success of any food safety program. The sanitarian needs to communicate with the person in charge to illustrate the significance of the violations noted and achieve compliance with the rules and regulations. Once the sanitarian leaves the facility after an inspection, it becomes the sole responsibility of the PIC to ensure that the facility remains in compliance with the Ohio Uniform Food Safety Code. Therefore, it is imperative that a sanitarian must not only be a skilled communicator but also be able to illustrate the potential problems with practices observed in the operation. By educating 13

14 the operator about the consequences of these practices and/or behaviors within the establishment, the PIC can address them immediately. The person in charge can further develop policies and procedures to prevent violations of the rules and regulations in the future. The FDA Model Food Code rules and regulation have changed over time. At one time, FDA focused on the structure, commonly referred to as floors, walls and ceiling inspection. In his article Bryan (2002) states the latest code and its periodic revisions put more emphasis on microbial controls. Nevertheless, the regulations still need modifications to be directed at prevention and control of foodborne pathogens. His article provides an historical review of food inspections in this country. When foodborne illness investigations were conducted, the information collected from structural inspections alone were not effective in preventing a foodborne illness outbreak. This allowed, over time, for the government to change to risk-based inspections. This has taken some time because in order to change the focus of inspections, the rules and regulations had to be changed. The rule making process is a slow process. The FDA Model Food Code is published in the odd years and is a resource used by most of the states in the development of their state rules and regulations. The FDA Model Food Code is completely rewritten every four years and updated during the second year of the four year term. The FDA regulations are based on the scientific evidence presented at the Conference for Food Protection which happens in even years. The rules are now based on the scientific evidence presented at the Conference for Food Protection to demonstrate that the risks are reduced to safe levels through the process illustrated. The event is attended by industry and government representatives. Based on the evidence presented, 14

15 the rules and regulations are vetted. Once the conference is completed, the FDA evaluates the information presented and reaches agreement on each of the issues discussed. Where the evidence shows the risks are reduced, the rule is often changed to reflect the science, in the FDA Model Food Code. Currently, in Ohio, there is a rule that requires the person in charge to be knowledgeable about food safety. It is critical to have staff trained in food safety as it relates to their job while working at a FSO/RFE in order to ensure the food that is prepared, served and/or sold is safe to eat. FDA (2007) program s standard number two requires the standardization of sanitarians in the food program. A FDA Certified Training Officer will develop and implement the standardization program after seeking the Cincinnati Board of Health approval. 15

16 Methods The Cincinnati Health Department currently conducts FSO and RFE inspections utilizing an electronic inspection program where a sanitarian records violations observed during an inspection. The violations are then printed on a document that the sanitarian reviews with the PIC. When the sanitarian returns to the office the information is down loaded to the Cincinnati Area Geographical Information System (CAGIS). The data collected by CAGIS was used in this project to group violations by CDC foodborne illness risk factors or non-cdc foodborne illness risk factors, risk class of the operation and inspector. The FDA Certified Training Officer designated which sections of the Ohio Uniform Food Safety Code were CDC and non-cdc foodborne illness risk factors. Examples of non-cdc foodborne illness risk factors would be dirty floors, walls and ceiling. Some examples of CDC foodborne illness risk factors are a food employee not washing their hands prior to putting on gloves, not wearing gloves when handling ready to eat food and not maintaining temperatures of 41 F and below or 135 F above on TCS food items. Identifiable information in regards to facilities and inspectors involved has been removed. The average number of CDC, non-cdc foodborne illness risk factors recorded for each facility is added up and divided by the number of facilities in risk categories that are inspected. This provides the average number of CDC and non-cdc foodborne illness risk factors recorded by each inspector for each risk category. The dependant variable is the total number of violations in the establishments. The independent variables are; the sanitarian, risk class, number of inspections, total mean number of violations per inspection, food establishment workers, and the location of the establishment within the city. The first hypothesis is the number of the CDC foodborne 16

17 illness risk factors are less likely to be cited than non-cdc food borne illness risk factors before the implementation of the food safety standardization program. Means of foodborne illness risk factors were compared between CDC and non-cdc foodborne illness risk factors using pair t-tests in each risk class. Total mean of the CDC foodborne illness risk factors and mean of the non-cdc foodborne illness risk factors were assessed for their association to risk classes using the Analysis of Variance (ANOVA) statistical method. Means were compared between risk classes under the ANOVA method framework and adjusting for multiple comparisons using Tukeys method. Statistical analyses were performed using PASW Statistics grad pack 18, SPSS, Inc., Chicago Illinois. 17

18 Results and Data Analysis The data was broken down into the four risk classes for analysis (see Appendix F for data). A paired t-test for each risk class was performed. The results for the risk class 1, 2, 3 and 4 establishments using the paired t-test showed a P-value < 0.05 indicating the data was significant. It affirmed the first hypothesis that there were more non-cdc foodborne illness risk factors documented during an inspection than the CDC foodborne illness risk factors Table 1. Table 1. Comparison of CDC and non-cdc foodborne illness risk factors. CDC $ non-cdc g P-value* Risk class ± ± Risk class ± ± Risk class ± ± Risk class ± ± Source: Cincinnati Health Department Key: $ Values in the cells are the mean ± std of CDC foodborne illness risk factors. g Values in the cells are the mean ± std of non-cdc foodborne illness risk factors. * P-value was obtained from t-tests. P-value <.05 is considered statistically significant. The results from the one way ANOVA statistical analysis using the multiple comparison method illustrate that the data is significant for the independent variables; total mean number of violations per inspection, mean number of CDC foodborne illness risk factors and non-cdc foodborne illness risk factors with a P-value <.05 with the dependant variable being the risk class. This suggests that the data is significant and there is a correlation between the mean number of violations cited per risk class as illustrated in Table 2. The mean number of violations cited per inspection between risk class 1 establishments and risk class 2 establishment went down from 2.33 to The mean for risk class 3 was 3.25 and greater than the mean for risk class 1 or 2 facilities. The mean number of violations cited at risk class 4 establishments was the highest at

19 These data indicate that the mean number of violations cited were reduced going from risk class 1 to risk class 2 establishments, then increased going to risk class 3 and increasing again for risk class 4 establishments. The results from the ANOVA statistical analysis were significant using the multiple comparison method but it does not affirm the second hypothesis that the number of violations increases as the risk class goes up in Table 2. Table 2. Summary of foodborne illness risk factors by risk class. Risk class* Total mean per CDC $ non-cdc g Insp k ± ± ± ± d 1.19 ± 0.59 d 2.06 ± 0.98 d dt 2.02 ± 1.00 dt 2.95 ± 1.04 dt Source: Cincinnati Health Department Key: *n=20 for each risk class. k Total mean number of CDC and non-cdc foodborne illness risk factors. $ Values in the cells are the mean ± std of CDC foodborne illness risk factors. g Values in the cells are the mean ± std of non-cdc foodborne illness risk factors. d Indicates the mean is larger than those of risk class 1 and 2 with a P-value <.05. t Indicates the mean is greater than those of risk class 1, 2 and 3 with a P-value <

20 Discussion In a risk class 1 establishment the major risks are sanitation, food labeling, sources of food, storage practices and food expiration dates. Because of the limited food handling in a risk class 1 establishment, the number of CDC foodborne illness risk factors is low. In many of these operations selling of food items is secondary to their primary business and is usually considered a courtesy for their customers and therefore, sanitation and storage practices would take a back seat in the business operation. This could explain the higher number of violations in a risk class 1 facility vs. a risk class 2 facility. Further investigation into the violations cited would help explain if it is due to a contamination, storage or food source problem. Risk class 2 facilities have a greater potential for violations of foodborne illness risk factors and associated adverse effects on the public, as compared to the risk class 1 facilities. Employee health and hygiene start to become risk factors in addition to the risks from risk class 1 operations. In many of these operations food represents a greater proportion of the sales in the establishment. There is a greater focus on training employees in food safety. Risk class 3 establishments are commonly referred to as cook and serve operations. These types of operations handle and prepare time/temperature controlled for safety (TCS) food items for sale or service. That is why the number of CDC and non CDC foodborne illness risk factors and associated violations cited increased. In a risk class 3 establishment, food sales are a main focus of the business. Risk class 4 establishments are the most complex food operations. They typically prepare food requiring several steps, involving multiple temperature controls to minimize bacterial growth and/or serve to high risk clientele. Because of the complexity of the 20

21 food preparation the opportunity for mistakes increase and is indicated in the number of violations cited per inspections. Typically in these operations the sale of food is the primary function. Of interest in this analysis is the standard deviation for risk class 1, 2 and 3 operations. CDC foodborne illness risk factors were 40 to 60 percent less than the non- CDC foodborne illness risk factors cited according to risk class. The standard deviation for non-cdc and CDC foodborne illness risk factors were almost a 1:1 ratio in the risk class 4 operations. Further study is therefore, needed to identify the factors that influence these results. The next step will be to standardize the staff practices at Cincinnati Health Department to verify if standardization impacts the number and type of violations cited during a standard inspection. 21

22 References Bryan, F. L. (2000). Conducting effective foodborne-illness investigations. Journal of Environmental Health, 63(1), Retrieved from A &aci=flag&tcit=0_1_0_0_0_0&index=BA&locID=ucinc_main&rlt=2 &origsearch=true&t=rk&s=1&r=d&secondary=false&o=&n=10&l=d&searcht erm=2nta&c=1&basicsearchoption=ke&bucket=per&su=conducting+effecti ve+foodborne-illness+investigations Bryan, F. (2002). Where we are in retail food safety, how we got to where we are, and how do we get there?. Journal of Environmental Health, 65(2), Hoag, M., Porter, C., Uppala, P., & Dyjack, D. (2007). A risk-based food inspection program. Journal of Environmental Health, 69(7), Martin, J. (2009, June 26). More stockyards packing it in. USA Today, pp. A.3. Ohio Department of Health (n.d.). Ohio Administrative Code , Retrieved from 21_02.1.PDF. Pallaske, G. (2005). Why are inspections necessary? [Letter to the editor]. Journal of Environmental Health, 67(6), Schmit, J. (2009, April 27). Broken system hid peanut plants risk. USA Today, pp. B.1. U.S. Department of Health & Human Services, U.S. Food and Drug Administration. (2004). FDA Report on the occurrence of foodborne illness risk factors in selected institutional foodservice, restaurant, and retail food store facility type (2004). Retrieved from RiskFactorReduction/RetailFoodRiskFactorStudies/ucm htm U.S. Department of Health & Human Services, U.S. Food and Drug Administration, FDA Food Protection Team. (2007). Voluntary national retail food regulatory program standards. Retrieved from m htm U.S. Department of Health & Human Services, U.S. Food and Drug Administration, FDA Retail Food Program Steering Committee. (2000). Report of the FDA retail food program database of foodborne illness risk factors. Retrieved from (Report) Walls, I. (2004). Using risk-based approaches for managing microbial safety. Nutrition Clinical Care, 7(4), Weber-Mosdorf, S. (2006). Reducing the risk. World Health Organization, Bulletin, 84(12), Weise, E. (2009, April 9). FDA Sends marshals to inspect company, USA Today, pp. B.1. World Health Organizations. (2007, March). Food safety and foodborne illness (Fact Sheet N 237). WHO Media centre: Author. 22

23 Woteki, C.E., & Kineman, B, D. (2003). Challenges and approaches to reducing foodborne illnesses. Annual Review of Nutrition, 23, doi: /annurev.nutr

24 Appendices Appendix A. Standardization Program for Food Service Operations (FSO) and Retail Food Establishment (RFE) Inspectors The U.S. Food and Drug Administration (FDA) has provided criteria for a Retail Food Protection Standardization Program. The purpose is to improve food safety and achieve a high degree of uniformity throughout the nation in both the requirements and the manner of enforcement of state and local laws governing sanitation in the retail food industry. FDA has standardized a Cincinnati Health Department (CHD) Sanitarian in the uniform interpretation of FDA Model Food Code Standards and preparation of appropriate forms. The CHD Food Protection Program has adopted a similar standardization program for the CHD staff. The requirements are essentially the same as those that the FDA Standardization Program used for the standardization of the CHD Sanitarian and are set forth in the Procedures for Standardization and Certification of FSO and RFE Inspectors. INTRODUCTION The FDA has provided the CHD Food Protection Program the current Procedures for Standardization and Certification of Retail Inspection/Training Officers. These procedures are focused on the 2001 FDA Model Food Code and have been adapted to the Ohio Uniform Food Safety Code (referenced hereafter as Rule). The updated standardization procedures involve food safety interventions, identification of risk factors known to contribute to foodborne illness, and in Risk Class 4 establishments a Critical Control Point Inspection (CCP) would be conducted. This document sets forth uniform procedure to be followed by the FDA Certified Training Officer for standardizing CHD food protection staff. Standardization of CHD food protection staff is highly recommended by the FDA and Ohio Department of Health (ODH) and Ohio Department of Agriculture (ODA). Standardization should provide increased accuracy and uniformity in inspection results and assist CHD in dealing with industry, the news media and court systems regarding any significant public health problem encountered in retail food establishments. Through the application of this procedure, the candidate will demonstrate knowledge and expertise in the understanding, application and interpretation of food code interventions; foodborne illness risk factors, HACCP principles, use of essential inspection equipment, and will exhibit necessary communication skills in conducting a FSO and RFE inspection. This procedure is not intended to provide basic training for newly employed candidates. The 24

25 candidate shall meet all the requirements of the procedure in order to be standardized by a FDA Certified Training Officer. PREREQUISITE TRAINING AND EXPERIENCE This section explains the prerequisite training and experience requirements for candidates to qualify for standardization. In order for the CHD Sanitarian to engage in the process of field inspections for the purpose of standardization and certification, the candidate must qualify by fulfilling the training and experience requirements specified in this section. These eligibility requirements only apply to first time candidates for standardization. Once standardized, the individual only needs to meet the standardization maintenance requirements. Any individual working in the field of food protection for CHD as a Registered Sanitarian may apply for standardization. The applicant shall provide their duties, credential (RS#) and length of service with the CHD. A. Applicants for initial CHD standardization must: 1. Be routinely engaged in retail food protection work; 2. Have job responsibility of conducting routine inspections and the capability to conduct food safety training or standardization of other regulatory personnel; 3. Must be a Registered Sanitarian (RS) 4. Have successfully completed, within the preceding two (2) years, at least 20 contact hours of training in the application of food science and related studies such as: microbiology, epidemiology, regulations, plan review or HACCP principles. 5. Have fulfilled one (1) or more of the following prerequisites: a. At least one (1) year of full-time experience in retail food establishment inspections within the past three (3) years, or b. At least 100 retail food establishment inspections performed within the last three (3) years, such as enforcement, training or consultation inspections. 6. Completed FDA ORAU Courses. B. When an applicant submits the Standardization Nomination Form (Annex 1), documentation of having fulfilled the above eligibility requirements must also be provided. The candidate must have their supervisor s approval and then sign, date and submit the form to the FDA Certified Training Officer in the Food Protection Program. C. Applicants who do not meet eligibility requirements may later request standardization, after completing the unmet requirements. 25

26 SCOPE A. Performance Areas The following areas of performance shall be addressed by the candidate during the Retail food establishment inspections and evaluated by the trainer. 1. Good Retail Practices (GRPs): The candidate shall demonstrate knowledge of rule provisions related to good retail practices and the ability to interpret and apply them. 2. Risk-Based Inspection: The candidate shall demonstrate knowledge of rule provisions related to rule interventions and risk factors which are most frequently associated with foodborne illness or injury. 3. Application of HACCP: The candidate shall demonstrate the ability to verify compliance with an existing HACCP plan and shall demonstrate the ability to apply all seven (7) HACCP principles to the inspection process. 4. Inspection Equipment: The candidate shall be equipped and familiar with inspection equipment essential to each FSO and RFE inspection. During the inspection, the candidate shall demonstrate knowledge of proper use of essential inspection equipment. 5. Communication: The candidate shall demonstrate the ability to effectively communicate with the person-in-charge (PIC) and explain significant inspection findings to the PIC at the conclusion of the inspection. B. Methodology 1. Initial Standardization: The trainer and the candidate shall conduct six (6) joint field inspections of retail food establishments, including at least one (1) with a HACCP plan, selected by the trainer. The FSOs and RFEs selected for inspection during standardization should be in risk class 3 or 4. All six (6) inspections for initial standardization should be completed within a reasonable period of time, not to exceed 12 months. 2. Standardization Recertification: The trainer and the candidate will conduct six (6) joint field inspections of retail food establishments, including at least one (1) with a HACCP plan, selected by the trainer. The food establishments selected for inspection during standardization recertification should be in risk class 3 or 4. All six (6) inspections for re-certification should be completed within a reasonable period of time, not to exceed three (3) years. 3. Options of the Trainer: The trainer has the option of adjusting the time period, type of facility selected, and methodology for inspection at any time to enhance the effectiveness of the standardization process. 4. Performance Evaluation Methods: The performance of the candidate shall be evaluated by the trainer using the methods outlined in the following table: 26

27 TABLE #1 SUMMARY OF INSPECTION METHODS FOR EACH PERFORMANCE AREA Performance Area Initial Standardization Re-Standardization Good Retail Practices Joint inspections Joint inspections Risk Based Inspections Application of HAACP Principals Joint inspections Risk Control Plan Process Flow Charts Verification of existing HAACP Plan, and Orally communicates seven (7) principals of HAACP Joint inspections Risk Control Plan Process Flow Charts (optional) Verification of existing HAACP Plan Inspection Equipment Field Observations Field Observations Communications Field Observations Field Observations NOTE: 1. All of the initial standardization requirements are to be completed during a total of six (6) joint evaluations with the trainer over a period not to exceed 12 months. 2. The maintenance requirements are to be completed during a total of six (6) joint evaluations with a trainer over a period not to exceed three (3) years. INSPECTION A. Field Exercise 1. Candidate Inspection Duties: During all joint FSO and RFE inspections, the candidate shall take the lead. The candidate shall make introductions and determine who the PIC is at the beginning of each inspection. The candidate shall record all observations and inspection data collected during the inspection. For the purpose of tracking temperature patterns, it is recommended that the candidate perform a preliminary survey of food temperatures early in each inspection. At various times during the field 27

28 exercise, the candidate shall be directed to perform specific tasks, such as explaining rule requirements, citing rule provisions, calibrating inspection equipment, and preparing flow charts or reviewing HACCP records to demonstrate proficiency in each area. 2. Performance Areas: During the inspection, the trainer shall observe and Evaluate the candidate based on the candidate s interpretation and application of the provisions in the Rule. Five (5) performance areas are included in the evaluation: a. Good Retail Practices (GRPs); b. Risk-Based Inspection; c. Application of HACCP principles; d. Inspection equipment; and e. Communication skills. 3. Comparison of Findings: Following each joint retail food establishment inspection the candidate shall compare his/her findings with the trainer s and the differences shall be thoroughly discussed before proceeding to the next inspection. The trainer shall retain copies of the candidate s inspection reports, flow charts, and RCP to document satisfactory completion of the standardization requirements. At the conclusion of the field exercise, the trainer shall tabulate and review the candidate s inspection results and other observations to determine if the candidate has successfully completed the requirements for standardization. B. Performance Criteria To be certified, the candidate shall meet the following criteria for each performance area: 1. Good Retail Practices and Risk-Based Inspection a. Inspection Report: At the conclusion of each inspection, the candidate shall complete a Standardization Inspection Report based on observations and data collected during the inspection. The candidate shall determine which items on the inspection report form were in or out of compliance, not observed, and/or not applicable based on the observations. b. Candidate Scoring: The trainer shall grade each Standardization Inspection Report by circling each incorrectly marked item and discussing these items with the candidate after each inspection. The trainer may mark an item D to reflect disagreement in a case where the candidate has the opportunity to make an observation or take a measurement and fails to do so. Intervention by the trainer would alert the candidate to the missed opportunity. A scoring of D should be used in instances such as when an opportunity to take a cooked hamburger temperature is available, but the candidate does not take the temperature and subsequently marks 5.1(B) as NO. The trainer s scoring of an item as D represents a disagreement between the candidate and the trainer. At the conclusion of each inspection, the trainer shall determine the number of disagreements on items and record 28

29 that number in the chart provided. At the completion of the final inspection, the trainer shall total the number of disagreements for all the retail food establishment inspections. (1) To satisfy the risk-based inspection performance area, the candidate shall not disagree with the trainer on more than 11 items in any one (1) establishment in this section of the Standardization Inspection Report and have a total average number of agreements of at least 90%. (2) To satisfy the GRPs inspection performance area, the candidate shall not disagree with the trainer on more than five (5) items in any one (1) establishment in this section of the Standardization Inspection Report and have a total average score of at least 85%. 2. Application of HACCP Principles During the retail food establishment inspections, the candidate shall demonstrate the proper inspection approach for retail food establishments with pre-existing HACCP plans and those without HACCP plans. Each candidate shall demonstrate an understanding of HACCP by: a. Flow Charts: Required for initial standardization and optional for standardization recertification (1) Preparing Process Flow Charts: During the joint inspections, The trainer shall select a total of three (3) processes for the candidate to describe on a flow chart (Annex 3). (a) Process 1 - No cook step ; (b) Process 2 - Same day service ; and (c) Process 3 - Complex food preparation. The candidate shall develop a flow chart using the information gained through actual observations of operational steps during an inspection. Information gained through discussion with the PIC and/or food workers should be used to substitute for a lack of observations of the operational steps not occurring during the inspection. On each flow chart, the candidate shall identify the hazards, CCPs, and Cls. The candidate shall indicate the Cls as stated in the Rule and by the establishment, if differing from those of the Rule. In addition, the candidate shall also indicate to the trainer, the CCPs which the establishment did not control. (2) Requirements: The trainer shall grade the three (3) flow charts based on the correct identification of hazards, CCPs and CLs. To satisfy this requirement, the three (3) flow charts may contain no more than two (2) errors or omissions. The FDA Retail HACCP Guide: Managing Food Safety, A HACCP Principles Guide for Operators of Food Service, Retail Food Stores, and Other Food Establishments at the Retail 29