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MEASURING THE EFFECTIVENESS OF THE NATION’S FOODSERVICE AND RETAIL FOOD PROTECTION SYSTEM. PRESENTATION OBJECTIVES. Purpose of FDA’s Study Review What the Study IS and IS NOT Review the Design of the Study Preview of 2003 Results Present Recommendations. BACKGROUND.

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presentation objectives
PRESENTATION OBJECTIVES
  • Purpose of FDA’s Study
  • Review What the Study ISand IS NOT
  • Review the Design of the Study
  • Preview of 2003 Results
  • Present Recommendations
background
BACKGROUND
  • FDA National Retail Food Steering Committee
  • Government Performance and Results Act (1993)“performance plans … measurable indicators”
introduction and purpose
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
introduction and purpose5
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
study time line
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
study time line7
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
study time line8
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
what the report is and is not
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
what the report is and is not10
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
methodology
METHODOLOGY
  • Scope: 3 Industry segments / 9 facility types:
    • Institutions
      • Hospitals
      • Nursing Homes
      • Elementary Schools
methodology12
METHODOLOGY
  • Scope: 3 Industry segments / 9 facility types:
    • Restaurants
      • Fast Food
      • Full-Service
background contributing factors
BACKGROUNDCONTRIBUTING FACTORS
  • Food from Unsafe Source
  • Inadequate Cooking
  • Improper Holding/Time-Temp.
  • Contaminated Equipment/Protection from Contamination
  • Poor Personal Hygiene
  • Other “Chemical Hazards”
methodology15
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

data analysis
DATA ANALYSIS
  • Three levels of data analysis are conducted for each of the 9 facility types

A. Out of Compliance percentagefor eachindividual data item

B.Out of Compliance percentagefor eachfoodborne illness risk factor

C.Overall IN Compliance percentagefor all 42 data items

determining the out of compliance percentage for each data item

Percent Out of Compliance =

Total Out of Compliance

Observations for a Data Item

X 100%

Total number of Observations

(IN and OUT) for the Data Item

Determining the Out of Compliance percentage for each DATA ITEM
determining out of compliance percentages foodborne illness risk factors
Determining Out of Compliance Percentages FOODBORNE ILLNESS RISK FACTORS

Observations of DATA ITEMS

FOODBORNE ILLNESS RISK FACTOR

determining the out of compliance percentage for each foodborne illness risk factor

Percent Out of Compliance =

Total Out of Compliance

Observations for a Risk Factor

X 100%

Total number of Observations

(IN and OUT) for the Risk Factor

Determining the Out of Compliance percentage for each FOODBORNE ILLNESS RISK FACTOR
example out of compliance percentage poor personal hygiene risk factor
ExampleOut of Compliance Percentage Poor Personal Hygiene - Risk Factor

Poor Personal Hygiene

5 DATA ITEMS – Data collection Form

12A13A14A15A15B

Poor Personal Hygiene - RISK FACTOR

determining overall in compliance percentages facility types
Determining Overall IN Compliance Percentages - FACILITY TYPES -

6 RISK FACTOR CATEGORIES

Overall In Compliance %

Facility Types

foodborne illness risk factor in need of priority attention 2000 report
Foodborne Illness Risk Factorin Need of Priority Attention (2000 Report)
  • Improper Holding/Time and Temperature
  • Poor Personal Hygiene
  • Contaminated Equipment / Protection from Contamination
2004 report data results and discussion
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

2004 report data results and discussion26
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

pathways to reach the goals
Pathways to Reach the Goals

FDA

Foodborne

Illness

Risk Factor

Study

Risk Factors

+

Intervention

Strategies

+

Performance

Measures

Program

Standards

Standardization &

Certification

recommendations for industry
RECOMMENDATIONS FOR INDUSTRY

ACTIVE MANAGERIAL

CONTROL OF FOODBORNE

ILLNESS RISK FACTORS

active managerial control
ACTIVE MANAGERIAL CONTROL

Purposeful incorporation of

specific actions or procedures

by industry management

to attain control of

foodborne illness risk factors

recommendations for industry38
RECOMMENDATIONS FOR INDUSTRY
  • Develop and implement Standard Operating Procedures (SOPs) to address FBI risk factors
recommendations for industry39
RECOMMENDATIONS FOR INDUSTRY
  • Provide employees with specific training and equipment to implement the SOPs
recommendations for industry40
RECOMMENDATIONS FOR INDUSTRY
  • Incorporate critical limits and measurable standards for control of FBI risk factors in SOPs
recommendations for industry41
RECOMMENDATIONS FOR INDUSTRY
  • Establish monitoring procedures that focus on critical processes and practices
recommendations for industry42
RECOMMENDATIONS FOR INDUSTRY
  • Identify methods to routinely assess the effectiveness of the SOPs
recommendations for industry43
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

recommendations for regulatory
RECOMMENDATIONS FOR REGULATORY
  • Use risk-based inspection methodology- risk factors should be the primary focus of every inspection
  • Provide flexible work schedules
recommendations for regulatory45
RECOMMENDATIONS FOR REGULATORY
  • Properly train and equip field personnel
  • Document compliance determination (IN; OUT; N.O.; N.A.)
recommendations for regulatory46
RECOMMENDATIONS FOR REGULATORY
  • Establish a dialog with industry foodservice and retail food store operators
  • Recognize existing industry Quality Assurance Systems and Training Programs
recommendations for regulatory47
RECOMMENDATIONS FOR REGULATORY
  • Take appropriate corrective action
    • Obtain immediate corrective action at the time of inspection for risk factors found out of compliance
recommendations for regulatory48
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
implement a consistent and effective enforcement protocol
IMPLEMENT A CONSISTENT AND EFFECTIVE ENFORCEMENT PROTOCOL
  • Develop enforcement procedures
  • Ensure credibility
voluntary national retail food regulatory program standards

VOLUNTARY NATIONAL RETAIL FOOD REGULATORY PROGRAM STANDARDS

Standards of Excellence for

Continuous Improvement

voluntary national retail food regulatory program standards51
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

voluntary national retail food regulatory program standards52
Voluntary National Retail Food Regulatory Program Standards

6. Compliance and Enforcement

7. Industry and Community Relations

8. Program Support and Resources

9. Self Assessment

voluntary national retail food regulatory program standards53
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
voluntary national retail food regulatory program standards54
Voluntary National Retail Food Regulatory Program Standards
  • Assist in identifying program areas most in need of additional resources
standards as a tool for continuous improvement
Standards as a Tool for Continuous Improvement

*Self Assess Improve

Measure

Plan

fda retail food program resource disk
FDA Retail Food Program Resource Disk

Contains all FDA’s technical guidance for retail food protection programs:

  • National Retail Food Program Standards
  • FDA’s 2000 Baseline Report
  • Software Program & Guidance documents for jurisdictions to use to conduct their own foodborne illness risk factor studies
fda retail food program resource disk57
FDA Retail Food Program Resource Disk
  • 2001 Food Code (AND 2003 Food Code Supplement)
  • FDA Standardization Procedures
  • HACCP @ Retail Guides
  • Plan Review Guide
  • Temporary Events Guides
program goal

PROGRAM GOAL

ACTIVE MANAGERIAL CONTROL

OF

FOODBORNE ILLNESS RISK FACTORS