PRESENTATION OBJECTIVES

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1 MEASURING THE EFFECTIVENESS OF THE NATION S RETAIL FOOD PROTECTION SYSTEM National Environmental Health Association Annual Education Conference June 24, 2009 John A. Marcello FDA Pacific Region Retail Food Specialist john.marcello@fda.hhs.gov 1 PRESENTATION OBJECTIVES Purpose of FDA s Study Review What the Study IS and IS NOT Review the Design of the Study Review the 2008 Data 2 There s a disconnect between the importance of the work we do, the nature of the work we do, and the passion we show for it. Nelson Fabian, Director National Environmental Health Association 3 1

2 INTRODUCTION AND PURPOSE Agency effort to change behaviors / practices related to foodborne illness Identify food safety practices and employee behavior most in need of attention 4 INTRODUCTION AND PURPOSE Establish a national baseline on the occurrence of foodborne illness risk factors Effort to collect sufficient data to measure patterns in the occurrence of foodborne illness risk factors over time 5 9 Facility Types = 9 Studies Institutional Foodservice - Hospitals - Nursing Homes - Elementary Schools (K-5) Restaurants - Fast Food Restaurants - Full Service Restaurants Retail Food Stores - Deli Departments/Stores - Meat & Poultry Departments/Markets - Seafood Departments/Stores - Produce Departments/Markets 6 2

3 STUDY TIME LINE ST Data Collection Report of the FDA Retail Food Program Database of Foodborne Illness Risk Factors (2000) Click On Program Standards Established Baseline Measures for 9 Facility Types 7 Industry Segment Percentage (%) of Observations found IN Compliance for ALL Data Items Facility Type 1998 Baseline % IN Compliance for Observations made of ALL data items 2010 FDA Improvement Goal Hospital 80% 85% Institutions Nursing Home 82% 87% Elementary School 80% 85% Restaurants Fast Food 74% 81% Full Service 60% 70% Deli 73% 80% Retail Food Meat & Poultry 81% 86% Seafood 83% 87% 8 Produce 76% 82% STUDY TIME LINE Risk Factors/Data Items in Need of Priority Attention nd Data Collection FDA Report on the Occurrence of Foodborne Illness Risk Factors within Selected Institutional Foodservice; Restaurant & Retail Food Facility Types (2004) rd Data Collection FDA Report on the Occurrence of Foodborne Illness Risk Factors within Selected Institutional Foodservice; Restaurant & Retail Food Facility Types (2009) Report will be available later in

4 2009 Report Report should be read and the data interpreted as a separate stand-alone assessment The report provides insights into food safety practices and employee behaviors needing priority attention 10 WHAT THE REPORT IS AND IS NOT IS a national assessment of the relative strengths & weaknesses of food safety systems designed to control the occurrence of foodborne illness risk factors IS NOT a correlation of the occurrence of foodborne illness risk factors with the actual incidence of human illness 11 WHAT THE REPORT IS AND IS NOT IS an assessment that used the 1997 Food Code provisions as the standard upon which observations of food safety practices are based IS NOT a determination of the industry s OR a specific establishment s regulatory compliance with prevailing laws & regulations 12 4

5 METHODOLOGY 2008 Data Collection: 850 Inspections 15,084 Observations Standardized Specialists conducted the inspections Selection of Establishments (Comparison Set Lists) 13 BACKGROUND CONTRIBUTING FACTORS Food from Unsafe Source Inadequate Cooking Improper Holding/Time-Temp. Contaminated Equipment/Protection from Contamination Poor Personal Hygiene Other Chemical Hazards 14 RISK FACTOR Number of Data Items for each Risk Factor Referenced Sections From Data Collection Form Food from Unsafe Sources 7 Sections 1 3 Inadequate Cooking 12 Sections 4 5 Improper Holding/Time Temperature 10 Sections 6 9 Contaminated Equipment/Protection from Contamination 5 Sections Poor Personal Hygiene 5 Sections Other (Chemical Contamination) 3 Section 16 TOTAL NUMBER OF DATA ITEMS

6 STATUS 5. Rapid Reheating For Hot Holding IN OUT NA NO A. PHF that is cooked and cooled on premises is rapidly reheated to 165 F. (74 C.) for 15 seconds for hot holding IN OUT NA NO B. Food reheated in a microwave is heated to 165 F. (74 C.) or higher IN OUT NA NO C. Commercially processed ready-to-eat food, reheated to 140 F. (60 C.) or above for hot holding IN OUT NA NO D. Remaining unsliced portions of roasts are reheated for hot holding using minimum oven parameters 16 METHODOLOGY Data Collection Records status for all individual data items IN In Compliance OUT Out of Compliance N.O. Not Observed N.A. Not Applicable 17 DATA ANALYSIS Three levels of data analysis are conducted for each of the 9 facility types A. Out of Compliance percentage for each individual data item B. Out of Compliance percentage for each foodborne illness risk factor C. Overall IN Compliance percentage for all 42 data items 18 6

7 Determining the Out of Compliance percentage for each DATA ITEM Percent Out of Compliance = Total number of Out of Compliance Observations for the Data Item Total number of Observations (IN and OUT) for the Data Item X 100% 19 Determining Out of Compliance percentages for each DATA ITEM The proportion of establishments where the data item was found Out of Compliance at least once when the practice or procedure could be observed 20 Restaurants - FULL SERVICE Percent (%) of Observations found Out of Compliance for each Data Item Improper Holding Time and Temperatur e PHF cooled to 70F in 2 hours/41f.. PHF held cold at 41F or below RTE, PHF date marked after 24 hours Commercially processed RTE, PH... PHF held hot at 140F or above RTE, PHF discarded after 4days/

8 Determining Out of Compliance Percentages FOODBORNE ILLNESS RISK FACTORS Observations of DATA ITEMS FOODBORNE ILLNESS RISK FACTOR 22 Example Out of Compliance Percentage Poor Personal Hygiene - Risk Factor Poor Personal Hygiene 5 DATA ITEMS Data collection Form 12A 13A 14A 15A 15B Poor Personal Hygiene - RISK FACTOR 23 Determining the Out of Compliance percentage for each FOODBORNE ILLNESS RISK FACTOR Percent Out of Compliance = Total number of Out of Compliance Observations for the Risk Factor Total number of Observations (IN and OUT) for the Risk Factor X 100% 24 8

9 S 1 Restaurants - FULL SERVICE Percent (%) of Observations found Out of Compliance for each Risk Factor Foodborne Illness Risk Factors Improper Holding/Time-T Poor Personal Hygiene Contaminated Equipment/ Other/Chemical Inadequate Cooking Food from Unsafe Source 25 Determining Overall IN Compliance Percentages - FACILITY TYPES - 6 RISK FACTOR CATEGORIES Overall In Compliance % ALL 42 DATA ITEMS 26 Determining the IN Compliance percentage for each FACILITY TYPE Percent IN Compliance = Total number of IN Compliance Observations for the original 42 data items Total number of Observations (IN and OUT) for the original 42 data items X 100% 27 9

10 Industry Segment Percentage (%) of Observations found IN Compliance for ALL Data Items Facility Type 1998 Baseline % IN Compliance for Observations made of ALL data items 2010 FDA Improvement Goal Hospital 80% 85% Institutions Nursing Home 82% 87% Elementary School 80% 85% Restaurants Fast Food 74% 81% Full Service 60% 70% Deli 73% 80% Retail Food Meat & Poultry 81% 86% Seafood 83% 87% 28 Produce 76% 82% 2009 Report Data Results and Discussion For each of the 9 facility types the Data Results will present: A. Overall Out of Compliance percentage for each of the foodborne illness risk factors B. Individual data Items that comprise each of the risk factors that are in need of priority attention Report Data Results and Discussion For each of the 9 facility types the Data Results will present: C. A national strengths/weaknesses assessment of management systems for controlling the occurrence of foodborne illness risk factors 30 10

11 S1 S 1 Restaurants - FULL SERVICE Percent (%) of Observations found Out of Compliance for each Risk Factor Foodborne Illness Risk Factors Improper Holding/Time-T Poor Personal Hygiene Contaminated Equipment/ Other/Chemical Inadequate Cooking Food from Unsafe Source 31 Restaurants - FULL SERVICE Percent (%) of Observations found Out of Compliance for each Data Item Improper Holding Time and Temperatur e PHF cooled to 70F in 2 hours/41f.. PHF held cold at 41F or below RTE, PHF date marked after 24 hours Commercially processed RTE, PH... PHF held hot at 140F or above RTE, PHF discarded after 4days/ Restaurants - FULL SERVICE 75.8 Poor Personal Hygiene Percent (%) of Observations found Out of Compliance for each Data Item Proper, adequate handwashing Prevention of contamination - hands Handwashing facility, convenient... Handwashing facility, cleanser/d.. Good hygienic practices 33 11

12 S 1 Restaurants - FULL SERVICE Percent (%) of Observations found Out of Compliance for each Data Item Contaminated Equipment/ Prevention from Contamination Surfaces/utensils clean/sanitized Raw/RTE foods separated Protected from environmental c... Raw animal foods, separated After being served, food is not re Restaurants FULL SERVICE FOODBORNE ILLNESS RISK FACTOR in need of Priority Attention Improper Holding/ Time & Temperature Poor Personal Hygiene Contaminated Equipment/ Protection from Contamination INDIVIDUAL DATA ITEMS in need of Priority Attention PHF/TCS cooled to 70ºF in 2 hours/41ºf in total of 6 hours PHF/TCS held cold at 41ºF or below RTE, PHF/TCS date marked after 24 hours Commercially-processed RTE, PHF/TCS date marked PHF/TCS held hot at 140ºF or above RTE, PHF/TCS discarded after 4 days/45ºf or 7 days/41ºf Proper, adequate handwashing Prevention of hand contamination Handwashing facility, convenient/accessible Handwashing facility, cleanser/drying device Good hygienic practices Surfaces/Utensils cleaned/sanitized Raw animal food separated from ready-to-eat foods Prevention from environmental contamination Raw animal foods separated from each other 35 Restaurants FULL SERVICE FOODBORNE ILLNESS RISK FACTOR in need of Priority Attention INDIVIDUAL DATA ITEMS in need of Priority Attention Other/Chemical Inadequate Cooking Poisonous or toxic materials properly identified, stored, and used PHF/TCS rapidly reheated to 165ºF/15 seconds for hot holding Poultry, stuffed fish, meat, pasta cooked to 165ºF for 15 seconds Food from Unsafe Sources Shellstock tags retained for 90 days 36 12

13 Project Limitations Field Limitations -- Time of the Inspection -- Length of the Inspection 37 Project Limitations Statistical Limitations Some comparisons not supported by statistical Design -- Region vs. Region, State vs. State 38 Project Limitations Statistical Limitations Some comparisons not supported by statistical Design -- Subcategories of Facility Types (e.g., chains of restaurants, retail food stores) 39 13

14 ADDITIONAL AREAS OF STUDY - Supplemental Data Items - Supplemental items designed to track impact of changes in the Food Code on compliance percentages in the study Example: Temperature for Hot Holding of PHF/TCS F or above F or above F or above 40 Hot Holding 140 F vs. 135 F Changing the hot holding temperature to 135 F had minimal impact on industry s control of holding foods hot NONE of the changes in IN Compliance percentages on the following slide are statistically significant 41 Facility Type Total IN 140 F Total OUT 140 F Total 140 F % IN 140 F Total IN 135 F Total OUT 135 F Total 135 F % IN Difference 135 F (% IN) Hospitals Nursing Homes Elementary Schools Fast Food Restaurants Full Service Restaurants Delis The number of observations for the Meat and Poultry, Seafood, and Produce facility types are too low to make comparisons or draw any conclusions 42 14

15 ADDITIONAL AREA OF STUDY Impact of a Certified Food Protection Manager The results of the study indicate the presence of a Certified Food Protection Manager is positively correlated to Overall IN Compliance percentages in 4 facility types - Full Service Restaurants - Delis - Seafood Departments - Produce Departments 43 Risk Factors with Statistically Significant Differences Between Establishments WITH and WITHOUT a Certified Food Protection Manager Facility Type Full Service Restaurants Delis Risk Factor Poor Personal Hygiene Contaminated Equipment/Protection from Contamination Improper Holding/Time and Temperature Poor Personal Hygiene Improper Holding/Time and Temperature 44 ADDTIONAL AREA OF STUDY Impact of a Certified Food Protection Manager There was NO risk factor for which the IN Compliance % for establishments without a certified manager exceeded the % for establishments with a certified manager in a statistically significant manner 45 15

16 Foodborne Illness Risk Factors in Need of Priority Attention (2000, 2004, and 2009 Reports) Improper Holding/Time and Temperature Poor Personal Hygiene Contaminated Equipment / Protection from Contamination 46 UNDER DEVELOPMENT Trend Analysis Report ( ) Target release date March 2010 Examine improvement or regression in the percentage of IN Compliance observations for each facility type Statistical analysis will be used to assess trends at the facility type level and the risk factor level Examine the effect of selected data items on improvement or regression in the IN Compliance observations for risk factors and facility types 47 If you re going to become known for becoming a very good health department, it is not going to be because you inspect the hell out of a septic tank restaurant (my insert). It is going to be because you prevented disease (foodborne illnesses). Peter Thornton, Director Volusia County Health Department, FL 48 16

17 An Inspection is an Assessment of an Establishment s Active Managerial Control of Foodborne Illness Risk Factors IT IS NOT AN INTERVENTION STRATEGY 49 Food Safety is a Behavioral Science 50 Pathways to Reach the Goals Program Standards FDA Foodborne Illness Risk Factor Study Risk Factors + Intervention Strategies + Performance Measures Risk Based Inspections 51 17

18 INTERVENTION STRATEGIES EXAMPLES Consultation/Training inspections focused on the responsibilities of the person-in-charge and food Safety management systems Olmsted County, MN (Innovative Approach) - Procedures - Training - Verification Focus on Oral Communication Cultures - Oregon Department of Health Study - Oregon Handwashing Initiative - FDA Industry Outreach Work Group 52 INTERVENTION STRATEGIES EXAMPLES Risk Control Plans for developing a long-term solution for out of control foodborne illness risk factors (San Diego County, CA) Employee Health/Personal Hygiene Initiatives - FDA Employee Health and Personal Hygiene Handbook - FDA Satellite Broadcast Using Employee Health and Personal Hygiene Measures November 19, RETAIL FOOD PROTECTION PROGRAM GOAL ACTIVE MANAGERIAL CONTROL OF FOODBORNE ILLNESS RISK FACTORS 54 18

STOP THE FOLLOWING SECTIONS WILL BE COMPLETED DURING THE MEETING

STOP THE FOLLOWING SECTIONS WILL BE COMPLETED DURING THE MEETING TIME IN: TIME OUT: SERVICE: 618 RESULT: FUTURE : TRAVEL TIME: EH# SR# PR# SOUTHERN NEVADA HEALTH DISTRICT FOOD SAFETY ASSESSMENT MEETING QUESTIONAIRE: Per SNHD Regulation 2-101.11 Responsibility, The Permit