MEASURING THE EFFECTIVENESS OF THE NATION

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MEASURING THE EFFECTIVENESS OF THE NATIONS
FOODSERVICE AND RETAIL FOOD PROTECTION SYSTEM
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PRESENTATION OBJECTIVES

• Purpose of FDAs Study
• Review What the Study IS and IS NOT
• Review the Design of the Study
• Preview of 2003 Results
• Present Recommendations

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BACKGROUND

• FDA National Retail Food Steering Committee
• Government Performance and Results Act
  (1993)performance plans measurable
  indicators

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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

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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

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STUDY TIME LINE

• 1998 1ST Data CollectionReport of the FDA Retail
  Food Program Database of Foodborne Illness Risk
  Factors (2000)
• Established a Baseline for 9 different
  foodservice and retail food facility types

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STUDY TIME LINE

• 2003 2nd Data CollectionFDA Report on the
  Occurrence of Foodborne Illness Risk Factors in
  Selected Institutional Foodservice, Restaurant
  and Retail Food Store Facility Types (2004)
• Begins the process for establishing multiple data
  collection periods

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STUDY TIME LINE

• 2008 3rd Data Collection will be
  conductedReport prepared for 2009 will begin
  the process of analyzing the three data sets
  (1998, 2003, and 2008) to assess improvement or
  regression changes from the 1998 Baseline

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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

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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 industrys OR a
  specific establishments regulatory compliance
  with prevailing laws regulations

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METHODOLOGY

• Scope 3 Industry segments / 9 facility types
• Institutions
• Hospitals
• Nursing Homes
• Elementary Schools

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METHODOLOGY

• Scope 3 Industry segments / 9 facility types
• Restaurants
• Fast Food
• Full-Service

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METHODOLOGY

• Scope 3 Industry segments / 9 facility types
• Retail Food Stores -- 4 departments
• Deli
• Meat and Poultry
• Seafood
• Produce

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METHODOLOGY

• 2003 Data Collection
• 926 Inspections
• 15,516 Observations
• Standardized Specialists conducted the
  inspections

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METHODOLOGY

• Selection of Project Locations
• Selection of Establishments (Comparison Lists)

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METHODOLOGY

• Confidentiality of Selected Establishments
• Observational vs. Regulatory inspections

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BACKGROUNDCONTRIBUTING FACTORS

• Food from Unsafe Source
• Inadequate Cooking
• Improper Holding/Time-Temp.
• Contaminated Equipment/Protection from
  Contamination
• Poor Personal Hygiene
• Other Chemical Hazards

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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

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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

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Determining the Out of Compliance percentage for
each DATA ITEM
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DeterminingOut 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

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Determining Out of Compliance Percentages
FOODBORNE ILLNESS RISK FACTORS

• Observations of DATA ITEMS
• FOODBORNE ILLNESS RISK FACTOR

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Determining the Out of Compliance percentage
for each FOODBORNE ILLNESS RISK FACTOR
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ExampleOut 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

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Determining Overall IN Compliance Percentages -
FACILITY TYPES -

• 6 RISK FACTOR CATEGORIES
• Overall In Compliance
• Facility Types

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FDA Report on the Occurrence of Foodborne
Illness Risk Factors in Selected Institutional
Foodservice, Restaurant and Retail Food Store
Facility Types(2004)
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2004 Report

• Report should be read and the data interpreted as
  a separate stand-alone assessment
• The report provides insights into food safety
  practice and employee behaviors needing priority
  attention

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Foodborne Illness Risk Factorin Need of Priority
Attention (2000 Report)

• Improper Holding/Time and Temperature
• Poor Personal Hygiene
• Contaminated Equipment / Protection from
  Contamination

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2004 ReportData 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

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2004 ReportData 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

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Project Limitations

• Field Limitations
• -- Time of the Inspection
• -- Length of the Inspection

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Project Limitations

• Statistical Limitations
• Some comparisons not supported by statistical
  Design
• -- Region vs. Region, State vs. State

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Project Limitations

• Statistical Limitations
• Some comparisons not supported by statistical
  Design
• -- Subcategories of Facility Types (e.g.,
  chains of restaurants, retail food stores)

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NEW AREAS OF STUDY- Supplemental Data Items -

• Study is designed to track improvements/regression
  in food safety practices and employee behaviors
• Supplement items designed to track impact of
  changes in the Food Code on compliance
  percentages in the study

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NEW AREA OF STUDY

• Impact of a Certified Food Protection Manager
• 4 facility types had Overall IN Compliance
  percentages that were significantly higher in
  establishments with certified managers

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NEW AREA OF STUDY

• - Fast Food Restaurants- Full Service
  Restaurants- Meat Poultry Departments-
  Produce Departments

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NEW 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

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NEW AREA OF STUDY

• DATA COLLECTION TIME- determined for each
  facility type- only includes actual time in
  the facility- does not include travel or
  report writing

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Pathways to Reach the Goals
FDA Foodborne Illness Risk
Factor Study
Risk Factors Intervention Strategies
Performance Measures
Program Standards
Standardization Certification
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RECOMMENDATIONS FOR INDUSTRY

• ACTIVE MANAGERIAL
• CONTROL OF FOODBORNE
• ILLNESS RISK FACTORS

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ACTIVE MANAGERIAL CONTROL

• Purposeful incorporation of
• specific actions or procedures
• by industry management
• to attain control of
• foodborne illness risk factors

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RECOMMENDATIONS FOR INDUSTRY

• Develop and implement Standard Operating
  Procedures (SOPs) to address FBI risk factors

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RECOMMENDATIONS FOR INDUSTRY

• Provide employees with specific training and
  equipment to implement the SOPs

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RECOMMENDATIONS FOR INDUSTRY

• Incorporate critical limits and measurable
  standards for control of FBI risk factors in SOPs

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RECOMMENDATIONS FOR INDUSTRY

• Establish monitoring procedures that focus on
  critical processes and practices

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RECOMMENDATIONS FOR INDUSTRY

• Identify methods to routinely assess the
  effectiveness of the SOPs

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RECOMMENDATIONS FOR INDUSTRY

• FDA guidance document for industryManaging Food
  Safety A Guide for Voluntary Use of HACCP
  Principles for Operators of Foodservice and
  Retail Establishments
• www.cfsan.fda.gov/dms/hret-toc.html

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RECOMMENDATIONS FOR REGULATORY

• Use risk-based inspection methodology- risk
  factors should be the primary focus of every
  inspection
• Provide flexible work schedules

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RECOMMENDATIONS FOR REGULATORY

• Properly train and equip field personnel
• Document compliance determination (IN OUT N.O.
  N.A.)

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RECOMMENDATIONS FOR REGULATORY

• Establish a dialog with industry foodservice and
  retail food store operators
• Recognize existing industry Quality Assurance
  Systems and Training Programs

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RECOMMENDATIONS FOR REGULATORY

• Take appropriate corrective action
• Obtain immediate corrective action at the time of
  inspection for risk factors found out of
  compliance

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RECOMMENDATIONS FOR REGULATORY

• Take appropriate corrective action
• Assist in developing Standard Operating Procedure
  and Risk Control Plans designed to attain
  long-term managerial control of risk factors

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IMPLEMENT A CONSISTENT AND EFFECTIVE ENFORCEMENT
PROTOCOL

• Develop enforcement procedures
• Ensure credibility

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VOLUNTARY NATIONAL RETAIL FOOD REGULATORY
PROGRAM STANDARDS

• Standards of Excellence for
• Continuous Improvement

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Voluntary National Retail Food Regulatory
Program Standards

• 1. Regulatory Foundation
• 2. Staff Training
• 3. HACCP Principles-based Inspection Program
• 4. Inspection Uniformity
• 5. Foodborne Illness and Food Security
• Preparedness and Response

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Voluntary National Retail Food Regulatory
Program Standards

• 6. Compliance and Enforcement
• 7. Industry and Community Relations
• 8. Program Support and Resources
• 9. Self Assessment

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Voluntary National Retail Food Regulatory
Program Standards

• Identify program areas where an agency can have
  the greatest impact on retail food safety.
• Promote wider application of effective FBI risk
  factor intervention strategies

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Voluntary National Retail Food Regulatory
Program Standards

• Assist in identifying program areas most in need
  of additional resources

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Standards as a Tool for Continuous Improvement

• Self Assess Improve

Measure
Plan
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FDA Retail Food Program Resource Disk

• Contains all FDAs technical guidance for
  retail food protection programs
• National Retail Food Program Standards
• FDAs 2000 Baseline Report
• Software Program Guidance documents for
  jurisdictions to use to conduct their own
  foodborne illness risk factor studies

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FDA Retail Food Program Resource Disk

• 2001 Food Code (AND 2003 Food Code Supplement)
• FDA Standardization Procedures
• HACCP _at_ Retail Guides
• Plan Review Guide
• Temporary Events Guides

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PROGRAM GOAL

• ACTIVE MANAGERIAL CONTROL
• OF
• FOODBORNE ILLNESS RISK FACTORS