FDA Foodborne Illness Risk Factor Study How It Will Be Used To Improve Food Safety 1 By the end of this presentation, you should be able to: State the purpose of FDA s Foodborne Illness Risk Factor Studies Describe how the study fits into FDA s Retail Food Protection Program Describe the statistically significant trends noted in FDA s first 10-year study period Identify future study considerations Explain the study s impact on the strategic direction of FDA s Retail Food Protection Program 2 STUDY OBJECTIVES Identify food safety practices and employee behaviors that require priority attention Establish a national Baseline and then analyze trends & assess progress Establish a model for use by state & local partners to conduct own studies 3 2013 NEHA AEC July 9 11, 2013 1
Purpose of the Reports The 3 Stand Alone Reports (1998, 2003, and 2008) provide insights into food safety practices that are most in need of priority attention The Trend Analysis Report provides a summary of significant improvement and/or regression trends over the 10-year Study period related to food safety practices within the retail food and foodservice industries www.fda.gov/food/guidanceregulation/retailfoodprotection/default.htm Under Spotlight Heading: Click on Retail Food Risk Factor Studies 4 Guidance for Interpreting Data from the FDA s First Study 5 9 s = 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 2013 NEHA AEC July 9 11, 2013 2
STUDY DESIGN CONTRIBUTING FACTORS Food from Unsafe Sources Inadequate Cooking Improper Holding/Time-Temp. Contaminated Equipment/Protection from Contamination Other Chemical Hazards 42 Individual Data Items comprise the Study 7 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 8 Calculation of % Out of Compliance Total # of OUT OBSERVATIONS Total # of IN OBSERVATIONS + Total # of OUT OBSERVATIONS X 100% Note: NO and NA marks are not used in the calculation, only observable marks. To calculate % IN Compliance, replace numerator with Total # of IN Compliance Observations. 9 2013 NEHA AEC July 9 11, 2013 3
S1 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 10 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 11 Restaurants - FULL SERVICE 75.8 Poor Personal Hygiene Percent (%) of Observations found Out of Compliance for each Data Item 46.3 29.2 29.2 24.2 Proper, adequate handwashing Prevention of contamination - hands Handwashing facility, convenient... Handwashing facility, cleanser/d.. Good hygienic practices 12 2013 NEHA AEC July 9 11, 2013 4
S 1 Restaurants - FULL SERVICE Percent (%) of Observations found Out of Compliance for each Risk Factor 54.7 40.9 35.0 Foodborne Illness Risk Factors 25.2 15.4 12.0 Improper Holding/Time-T Poor Personal Hygiene Contaminated Equipment/ Other/Chemical Inadequate Cooking Food from Unsafe Source 13 RESTAURANTS Full Service Foodborne Illness RISK FACTOR 6 Individual DATA ITEMS PHF/TCS Food cooled to 70ºF in 2 hours/41ºf in a total of 6 hours IMPROPER HOLDING / TIME & TEMPERATURE PHF/TCS Food held cold at 41ºF or below RTE, PHF/TCS Food date marked after 24 hours Commercially processed RTE, PHF/TCS Food date marked PHF/TCS Food held hot at 140ºF or above RTE, PHF/TCS Food discarded after 4 days/45ºf or 7 days/41ºf 14 RESTAURANTS Full Service Foodborne Illness RISK FACTOR Individual DATA ITEMS Proper, adequate handwashing POOR PERSONAL HYGIENE Prevention of hand contamination Handwashing facility, convenient/accessible Handwashing facility, cleanser/drying device Good hygienic practices 15 2013 NEHA AEC July 9 11, 2013 5
Percentage(%) of observations found IN Compliance for ALL 42 Data Items Industry Segment Institutions Restaurants Retail Food 1998 Baseline % In Compliance for Observations made of ALL data items 2010 FDA Improvement Goal\ Hospitals 80% 86% Nursing Homes 82% 87% Elementary Schools 80% 85% Fast Food 74% 81% Full Service 60% 70% Delis 73% 80% Meat & Poultry 81% 86% Seafood 83% 87% Produce 76% 82% 16 1998 2008 Trend Analysis Summary 17 Industry Segment Institutional Foodservice Restaurant Retail Food Stores Percentage(%) of observations found IN Compliance for ALL 42 Data Items 1998 Baseline % IN Compliance for Observations made of ALL DATA ITEMS 2008 % IN Compliance for Observations made of ALL DATA ITEMS 2010 FDA Target Improvement Goal Hospitals 80% 81% 85% Nursing Homes 82% 83% 87% Elementary Schools 80% 84% 85% Fast Food 74% 78% 81% Full Service 60% 64% 70% Delis 73% 74% 80% Meat & Poultry 81% 88% 86% Seafood 83% 86% 87% Produce 76% 84% 82% 18 2013 NEHA AEC July 9 11, 2013 6
Industry Segment Institutional Foodservice Restaurant Retail Food Stores Percentage(%) of observations found IN Compliance for ALL 42 Data Items 1998 Baseline % IN Compliance for Observations made of ALL DATA ITEMS 2008 % IN Compliance for Observations made of ALL DATA ITEMS 2010 FDA Target Improvement Goal Hospitals 80% 81% 85% Nursing Homes 82% 83% 87% Elementary Schools 80% 84% 85% Fast Food 74% 78% 81% Full Service 60% 64% 70% Delis 73% 74% 80% Meat & Poultry 81% 88% 86% Seafood 83% 86% 87% Produce 76% 84% 82% 19 Industry Segment Institutional Foodservice Restaurants Foodborne Illness Risk Factors with Statistically Significant Improvement Foodborne Illness Risk Factors with Statistically Significant Improvement Hospitals Inadequate Cooking Elementary Schools Fast Food Full Service Contaminated Equipment / Protection from Contamination Delis Meat & Poultry Retail Food Stores Seafood Produce NOTE: The Nursing Home facility type did not show statistically significant improvement or regression for any 20 of the foodborne illness risk factors during the 10-year study period. Industry Segment Institutional Foodservice Restaurants Foodborne Illness Risk Factors with Statistically Significant Improvement Foodborne Illness Risk Factors with Statistically Significant Improvement Hospitals Inadequate Cooking Elementary Schools Fast Food Full Service Contaminated Equipment / Protection from Contamination Delis Meat & Poultry Retail Food Stores Seafood Produce NOTE: The Nursing Home facility type did not show statistically significant improvement or regression for any 21 of the foodborne illness risk factors during the 10-year study period. 2013 NEHA AEC July 9 11, 2013 7
Industry Segment Institutional Foodservice Restaurants Foodborne Illness Risk Factors with Statistically Significant Improvement Foodborne Illness Risk Factors with Statistically Significant Improvement Hospitals Inadequate Cooking Elementary Schools Fast Food Full Service Contaminated Equipment / Protection from Contamination Delis Meat & Poultry Retail Food Stores Seafood Produce NOTE: The Nursing Home facility type did not show statistically significant improvement or regression for any 22 of the foodborne illness risk factors during the 10-year study period. Some Significant Improvement Trends for Data Items Proper Handwashing (4 out of the 9 facility types) - Elementary Schools - Fast Food Restaurants - Meat & Poultry Markets / Departments - Produce Markets / Departments 23 Some Significant Improvement Trends for Data Items No bare hand contact with Ready-to-Eat Foods (6 out of 9 facility types) - Hospitals - Elementary Schools - Fast Food Restaurants - Full Service Restaurants - Deli Departments / Stores - Produce Markets / Departments 24 2013 NEHA AEC July 9 11, 2013 8
Some Significant Improvement Trends for Data Items Date Marking of Ready-to-Eat, PHF/TCS Foods prepared on site. (7 out of 9 facility types) - Hospitals - Nursing Homes - Elementary Schools - Fast Food Restaurants - Full Service Restaurants - Deli Departments / Stores - Produce Markets / Departments 25 TAKEAWAYS FROM TREND ANALYSIS Significant gains made over 10-year span Biggest improvement in data items that had relatively high Out of Compliance percentages at the beginning of the 10- year study Efforts on part of industry and regulatory appear to be having an impact on the occurrence of foodborne illness risk factors within the retail food segment of the industry 26 TAKEAWAYS FROM TREND ANALYSIS Three foodborne illness risk factors where significant improvement was noted but are still in need of attention Improper Holding/Time & Temperature Poor Personal Hygiene Contaminated Equipment / Protection from Contamination 27 2013 NEHA AEC July 9 11, 2013 9
How Can the Study Data Be Used to Focus Intervention Strategies? 28 Impact of a Certified Food Protection Manager 2008 Data Collection Period 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 29 Risk Factors with Statistically Significant Differences Between Establishments WITH and WITHOUT a Certified Food Protection Manager Foodborne Illness Risk Factor Full Service Restaurants Contaminated Equipment / Protection from Contamination Improper Holding / Time & Temperature Delis Improper Holding / Time and Temperature 30 2013 NEHA AEC July 9 11, 2013 10
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 31 Percentage of Foodborne Illness Attributable to Various Pathogens Bacteria 30% Protozoa 3% Viruses 67% Mead et al., 1999 32 Applying the Data to Retail Food Protection Programs Handwashing IN Compliance % 1998 2003 2008 No Bare Hand Contact With RTE Food IN Compliance % 1998 2003 2008 Full Service Restaurants 18.5% 26.5% 24.2% Full Service Restaurants 23.5% 42.3% 53.7% 33 2013 NEHA AEC July 9 11, 2013 11
34 34 Foodborne Illness Testimonials FDA Web Page http://www.fda.gov/ ForFederalStateandLocalOfficials/ FoodSafetySystem/ucm350332.htm 35 Areas of Future Study and FDA s Strategic Direction Relative to Retail Food Safety 36 2013 NEHA AEC July 9 11, 2013 12
Considerations for Next Risk Factor Study Focus on One Industry Segment at a Time 2013/2014 - Restaurants (full service & quick service) Larger Sample Size, Smaller Error, Firmer Conclusions Use Regional Specialists Again More Efficient Data Collection Techniques Electronic Capture; Real-Time Database Considerations for Next Risk Factor Study Streamlined data collection - fewer data items, more easily communicated 10 Primary Items & 9 Secondary Items Establish national performance metric % of establishments with X number of Primary Items Not in Compliance Examine other correlations based on demographics Establishment characteristics (e.g. chain vs. independent; size) Considerations for Next Risk Factor Study Examine impact of different interventions and regulatory strategies on specific risk factor occurrence More in-depth assessment of management practices in place (procedures, training, & monitoring) Assess degree of non-compliance for select items 2013 NEHA AEC July 9 11, 2013 13
Retail Food Safety Initiative Announced in conjunction with October 2010 release of Risk Factor Study Reports Recognition that food safety at point of sale and service is important part of FDA s farm-to-table strategy Acknowledge key partnerships as part of an integrated food safety system Retail Initiative Task Force established FDA s Strategic Direction for Retail Increase the presence of certified food protection managers Strengthen active managerial control at the retail level and ensure better compliance Improve the quality of, and access to, training of retail food personnel by the industry FDA s Strategic Direction Promote more widespread, uniform, and complete adoption & implementation of the FDA Food Code Ensure prevention-oriented, science-based food safety principles are utilized at the retail level 2013 NEHA AEC July 9 11, 2013 14
FDA s Strategic Direction Create an enhanced local regulatory environment for retail food operations by: Wider implementation of the Voluntary National Retail Food Regulatory Program Standards Seeking increased multi-year funding for state/local/tribal programs Developing programs to ensure universal participation by state/local/tribal regulators in consistent, high-quality training QUESTIONS John Marcello FDA Pacific Region Retail Food Specialist john.marcello@fda.hhs.gov (480) 829-7396 ext. 2035 44 2013 NEHA AEC July 9 11, 2013 15