I. Introduction And Purpose and II. Methodology, of the FDA Report on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice, Restaurant, and Retail Food Store Facility Types (2004)
I. INTRODUCTION AND PURPOSE
Ensuring safe food is an important public health priority for our nation. For years regulatory and industry food safety programs have focused on reducing the incidence of foodborne illness. Despite these efforts, the 1996 report "Reinventing Food Regulations" [National Performance Review] concluded that foodborne illness caused by harmful bacteria and other pathogenic microorganisms in meat, poultry, seafood, dairy products, and a host of other foods is a significant public health problem in the United States.
The National Performance Review Report looked at the occurrence of foodborne illness from a farm-to-table perspective. It did not attempt to define the scope of the problem within specific sectors of the farm-to-table continuum. In order to determine the effectiveness of regulatory and industry food safety programs within foodservice and retail food store facility types, a study was needed that would assess information associated with the occurrence of foodborne illness and be specific to this segment of the industry.
FDA's Response to the 1996 National Performance Review Report
In response to the 1996 National Performance Review Report and subsequent input from state and local regulatory partners, FDA established the National Retail Food Steering Committee (Steering Committee) including representation from the Center for Food Safety and Applied Nutrition (CFSAN), Office of Regulatory Affairs (ORA), Division of Federal/State Relations (DFSR), Division of Human Resource Development (DHRD), and the Interstate Travel Program (ITP) Field Team. The Steering Committee is responsible for reviewing retail food program objectives and coordinating program activities.
The 1993 Government Performance and Results Act required Federal agencies to develop performance plans that included measurable goals and performance indicators. To establish a strategic direction for the retail food program, the Steering Committee made it a priority to identify a performance measurement to assess the effectiveness of the nation's retail food protection system. The initiatives in the subsequent strategic plan are directed toward developing a national retail food program model that can be used by federal, state, local, and tribal regulatory agencies to:
- Identify essential food safety program performance measurements;
- Assess strengths and gaps in the design, structure, and delivery of program services;
- Establish program priorities and intervention strategies focused on reducing the occurrence of foodborne illness risk factors; and
- Create a mechanism that justifies program resources and allocates them to program areas that will provide the most significant public health benefits.
Identifying Performance Measures for Regulatory Retail Food Programs
Although the level of foodborne illness would be the ideal retail food program performance indicator, the occurrence of foodborne illness is grossly underreported. This makes the incidence of foodborne illness an unreliable program measurement. As an alternative, the occurrence of foodborne illness risk factors was selected as the performance indicator. The Centers for Disease Control and Prevention (CDC) Surveillance Report for 1988 - 1992 identifies the food preparation practices and behaviors most often associated with foodborne illness outbreaks. These reported contributing factors relate to food safety concerns within foodservice and retail food store facility types and include:
- Food from Unsafe Sources
- Inadequate Cooking
- Improper Holding Temperatures
- Contaminated Equipment
- Poor Personal Hygiene
For the purposes of this long-term study, FDA designated these five categories of contributing factors as "foodborne illness risk factors." Note that this use of the term "risk factor" should not be confused with another use of the same phrase to describe characteristics of the person, food or location that are statistically linked to illness by an epidemiological investication. Using the results from the 1998 data collection as a baseline, the Steering Committee has established a goal of reducing the Out of Compliance percentage of observations of the original forty-two data items related to foodborne illness risk factors in institutional foodservice, restaurants, and retail food establishments by 25% by 2010.
Any study designed to measure trends requires analysis of the subject matter over a period of time. No single point in time can be used to derive conclusions. Rather, it is a review and evaluation of the data collected at several intervals that provide the basis for drawing conclusions.
This project was designed to collect data on the occurrence of the foodborne illness risk factors in selected foodservice and retail food establishments at five-year intervals. These data collection efforts are designed to get an accurate picture of the extent to which foodservice and retail food operations have control over the risk factors during each data collection period. Using the data from multiple collection periods, FDA hopes to evaluate trends and determine whether progress is being made toward the goals of reducing the occurrence of foodborne illness risk factors.
In order to detect trends of improvement and/or regression in this study, it is necessary to collect data from at least three, and preferably more, periods in time.
|Data Collection Period||Title of the Report||Project Objectives|
|1998||Report of the FDA Retail Food Program Database of Foodborne Illness Risk Factors. Published in 2000||Establish a Baseline for nine selected institutional foodservice, restaurant, & retail food store facility types|
|2003||FDA Report on the Occurrence of Foodborne Illness Risk Factors within Selected Institutional Foodservice; Restaurant & Retail Food Store Facility Types (2004)||Identify risk factors and data items in need of priority attention. Collect 2nd of at least three sets of data needed to assess trends in occurrence of risk factors.|
|2008||Target Report Date: 2009||Use the information from the three data sets to assess improvement/regression changes from the 1998 Baseline|
1998 Study Established the First National Baseline
Using the results of the 1998 data collection, the 2000 Report of the FDA Retail Food Program Database of Foodborne Illness Risk Factors established the first-ever national baseline on the occurrence of foodborne illness risk factors within institutional foodservice, restaurant, and retail food store facility types. By establishing a baseline, regulatory and industry food safety professionals have a performance measure upon which to assess the impact of efforts directed to positively change behaviors and practices related to foodborne illness.
The data in Table 2 presents the IN Compliance status of forty-two data items used to establish the 1998 Baseline measurements and the FDA 2010 improvement goal for each of the nine facility types included in the study. These measurements represent the "overall IN Compliance percentages" for each of the nine facility types.
|1998 Baseline* |
% IN Compliance
for Observations made of ALL data items
(rounded to nearest %)
(rounded to nearest %)
|Meat & Poultry||81%||86%|
|*1998 Baseline calculation:|
|Percent IN Compliance =|
|All applicable, observable, IN Compliance data items within all risk factor categories X 100% |
Total number of observations (IN and OUT)
|**To be consistent with the Retail Food Steering Committee's established performance goal, a ten-year goal of 25% reduction for the Percent Out of Compliance was set as the target for improvement. An example computation using Hospitals illustrates how the specific ten-year improvement goal percentages were attained:|
|Hospital:||1998 Baseline % = 80% IN Compliance (20% Out of Compliance) |
Improvement goal = 25% reduction in the Percent Out of Compliance
|25% of 20% = 5% |
Baseline Out of Compliance 20% - 5% = 15%
Improvement goal = 85% IN Compliance
2003 Study should be interpreted as a separate stand alone report
The FDA Report on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice, Restaurants and Retail Food Facility Types (2004) summarizes results from the second data collection conducted in 2003. The results contained in this report provide insight into the effectiveness of industry management systems and food safety regulatory programs in controlling foodborne illness risk factors in certain retail and foodservice operations. This report should be read and the data interpreted as a separate stand-alone report. Additional data are needed before any meaningful assessments of trends can be made for each of the facility types. This report makes no attempt to draw comparisons between the results of the 1998 and 2003 data collections.
2008 Study will begin the process for assessing risk factor changes
A third data collection is planned for 2008. Having data from three separate years over a ten-year span should shed light on whether changes in the occurrence of risk factors in foodservice and retail food establishments are taking place.
B. Study Design and Objectives
This study contains nine separate baselines, one for each of the nine different facility types. The target industry segments for this project are institutional foodservice, restaurants, and retail food stores. Of the nine facility types, three were associated with institutional foodservice - hospitals, nursing homes, and elementary schools (K - 5). The restaurant industry segment was comprised of two facility types - fast food and full service. Four facility types were departments of retail food stores and independent specialty operations related to deli, meat and poultry, seafood, and produce.
Although the data presented were collected from many locations across the U.S., this study was not designed to support comparisons of states, counties, cities, or even regions of the U.S. Not only would it be inappropriate from a statistical standpoint, but such comparisons might be combined with other information, such as the location of FDA Regional Retail Food Specialists, to identify some of the establishments eligible for random selection in future studies. This information would bias later data collection efforts.
The data from this project provided input into the Healthy People 2010 Initiative under Food Safety Objective 10.6. This objective is designed to improve food preparation practices and food employee behaviors within institutional food service establishments, restaurants, and retail food stores.
Guidance for Interpreting the Results in this Report
All statistical studies have limitations. How a research project is designed and implemented can have a profound impact on the interpretation of the data.
Prior to discussing methodology and data results, it is essential to review what the 2003 study has been designed to do and, equally important, what it is NOT designed to do. Without this discussion, the data presented may quite easily be misinterpreted or used inappropriately.
This study was designed using assessment criteria based on the 1997 FDA Food Code
The project is designed to track the foodservice and retail food industries' control of foodborne illness risk factors using specific requirements in the 1997 FDA Food Code. Since one of the purposes of the project is to track changes in the Percent IN Compliance of observations related to industry's efforts to control foodborne illness risk factors, the standard of measurement used to evaluate these comparisons must remain constant for each of the data collection periods (1998, 2003, and 2008). For example, suppose the recommended standard in the Food Code was relaxed and we changed the data item accordingly. If the compliance percentage is then found to increase, we would not know if this was due to better employee practices or simply the change in the recommended standard.
The data collection inspection form used for this report (see Baseline Data Collection Form) contains two sections. Forty-two individual data items comprise the first section of the form. Each of the data items is listed under one of the foodborne illness risk factors. These forty-two data items will remain the same for all three data collection periods (1998, 2003, and 2008).
Since 1997, the FDA Food Code has been updated several times. A second section has been included on the data collection inspection form under the title, "Supplemental Items," to assess the impact of changes made in the 1997 FDA Food Code on IN Compliance percentages for foodborne illness risk factors and data items. The design of the data collection inspection form ensures a means to track changes over time against a constant standard of measure and provides a mechanism for evaluating the potential impact of changes in Food Code provisions on the data collected.
Only a couple of individual data items within the study contain criteria or critical limits that have been updated since the release of the 1997 FDA Food Code. A comparative assessment was conducted on what impact, if any, these changes in the Food Code had on the overall IN compliance percentages. The results and discussion of these data items are presented in Section VI, New Areas of Study - Supplemental Data Items.
The study was not designed to measure regulatory compliance with specific state or local Food Codes
The forty-two data items used to track changes in the occurrence of foodborne illness risk factors were based on the provisions within the 1997 FDA Food Code. No attempt was made to determine if an establishment would have been found to be substantially IN Compliance with prevailing state, local, or tribal regulations.
The FDA Food Code is neither federal law nor federal regulation and is not preemptive of state, local, or tribal food safety requirements. In many cases, the FDA Food Code and prevailing regulatory standards of measurement were the same.
For some data items, the standard of measurement was different. Foodservice industry practices observed by the Specialists may have been IN Compliance with less stringent state or local laws even though the report notes they were not IN Compliance with the 1997 FDA Food Code. Differences in state and/or local requirements have no bearing on the findings in this study since the 1997 FDA Food Code was the assessment criterion. By using the 1997 FDA Food Code as the standard of measurement, the study employed a single document of foodservice and retail food safety standards that have undergone national review.
This study was designed to assess industry management systems essential to the control of foodborne illness risk factors
In the 1998 and 2003 FDA data collections, observations were made for multiple data items (FDA Food Code requirements) that comprise food safety practices and employee behaviors specific to each of the five risk factors. Some of these individual data items did not have a direct link to human illness, but were essential to the active managerial control of foodborne illness risk factors.
For example, improper handwashing, which falls under the Poor Personal Hygiene risk factor, is associated with the spread of pathogens. There is a direct link between improper handwashing and potential human illness. The Poor Personal Hygiene risk factor also included data items related to the availability of hand soap and sanitary towels/hand drying devices. The availability of hand soap and sanitary towels/hand drying devices, though not directly linked to human illness, is an essential component of the management system needed to ensure proper handwashing.
Each of the risk factors in this report included individual data items that had a direct link to human illness and/or industry management practices essential to their control. For instance, the retention of shellstock tags was included in the evaluation of food source and date marking of ready-to-eat potentially hazardous foods was part of an assessment of holding temperatures.
An additional category, "Other," was included to capture potential food safety risks related to possible contamination by toxic or unapproved chemicals for each of the facility types.
This study was designed to focus only on a specific point in the farm-to-table food safety continuum
Pathogens may enter the food supply at any point in the farm-to-table food safety continuum. All industry sectors within this continuum have a responsibility for ensuring safe food.
The 2003 report covered only facility types that comprise institutional foodservice, restaurant, and retail food store operations. The report does not attempt to assess the occurrence of foodborne illness risk factors within other sectors of the food industry or in private homes.
Consumers may find the information in this report useful when trying to better understand food safety risks. This report, however, does not provide specific information about the relative risks associated with the many options consumers have when it comes to dining and purchasing food.
Specific retail food safety information is available to consumers from a number of sources including public web sites maintained by federal, state, and local regulatory agencies, universities, consumer organizations, as well as, the foodservice and retail food industries. One such federal food safety site is www.foodsafety.gov.
Study Design Summary
This study is intended to fill a void that currently exists in the assessment of program effectiveness for controlling foodborne illness risk factors. It identifies the most urgent priorities for improvement. The following table provides a summary of the purpose and objectives of the ten-year study.
|The Study IS Designed to:||The Study IS NOT Designed to|
|Measure trends over time in regulatory & industry efforts to reduce the occurrence of foodborne illness risk factors||Support comparisons of geographic areas, states, counties, cities or chains of foodservice/retail food store operations|
|Assess the occurrence of foodborne illness risk factors and management practices essential to their control in selected institutional foodservice, restaurant and retail food facility types||Assess the occurrence of foodborne illness risk factors in other industry sectors of the farm-to-table continuum|
|Use the 1997 FDA Food Code provisions as the standard of measurement upon which to make observations of employee practices & behaviors||Determine an establishment's regulatory compliance with prevailing state, local, or tribal regulations|
|Identify employee practices and behaviors that contribute to the occurrence of foodborne illness that are in need of priority attention||Correlate the occurrence of foodborne disease risk factors with actual incidences of human illness|
In order to detect trends of improvement and/or regression from the 1998 baseline measurements, it is critical that the methodology used to collect data, as well as the study design, remain consistent for every data collection. For the 2003 data collection period, supplemental data items have been added to capture additional information not collected in 1998. The following sections of the report will present an overview of the methodology used in this study as originally designed in 1998. In addition, unique elements to the 2003 data collection (i.e. supplemental data items) are described.
A. Selection of Facility Types
For this study, nine facility types were chosen from three different segments of the foodservice and retail food industry.
- Nursing Homes
- Elementary Schools
- Fast Food Restaurants
- Full Service Restaurants
RETAIL FOOD STORES
- Deli Departments
- Meat and Poultry Departments
- Seafood Departments
- Produce Departments
The selected institutional foodservice, restaurant and retail food store facility types included in this project represent over a million varied and diverse types of operations in the United States.
A direct focus on these industry segments allows FDA to track trends in the occurrence of foodborne illness risk factors in the vast majority of establishment types at the retail level that serve both general and highly susceptible populations. For the purposes of this report, a highly susceptible population was a group of persons who are more likely than the general population to experience foodborne disease due to their current health status or age.
B. Eligibility of Establishments for Selection
In determining the pool of establishments eligible for selection, an effort was made to exclude operations that handle only pre-packaged food items or conduct low-risk food preparation activities.
Establishments that were selected included moderate to high-risk operations, such as establishments that:
- Served a highly susceptible population (i.e., hospitals, nursing homes, elementary schools);
- Handled ingredients extensively; or
- Conducted a variety of food preparation processes.
Annex 4 of the 1997 FDA Food Code contains a suggested protocol for grouping establishments by risk. The following Risk Categorization of Food Establishments summary provided a general guideline for determining the type of establishments included in the study.
|RISK TYPE CATEGORY DESCRIPTION|
|1||Pre-packaged, non-potentially hazardous foods only. Limited preparation of nonpotentially |
hazardous foods only.
|2||Limited menu (1 or 2 main items). Pre-packaged, raw ingredients are cooked or |
prepared to order. Retail food operations exclude deli or seafood operations
departments. Raw ingredients require minimal assembly. Most products are
cooked/prepared and served immediately. Hot and cold holding of potentially
hazardous foods is restricted to single meal service. Preparation processes
requiring cooking, cooling, and reheating are limited to 1 or 2 potentially
|3||Extensive handling of raw ingredients. Preparation process includes the cooking, |
cooling, and reheating of potentially hazardous foods. A variety of processes
require hot and cold holding of potentially hazardous food. Advance preparation
for next day-service is limited to 2 or 3 items. Retail food operations include deli
and seafood departments. Establishments doing food processing at retail.
|4||Extensive handling of raw ingredients. Preparation processes include the |
cooking, cooling, and reheating of potentially hazardous foods. A variety of
processes require hot and cold holding of potentially hazardous foods. Food
processes include advanced preparation for next-day service. Category would
also include those facilities whose primary service population is
|5||Extensive handling of raw ingredients. Food processing at the retail level, e.g., |
smoking and curing, reduced oxygen packaging for extended shelf-life.
The vast majority of selected establishments fell into risk categories 3 - 5 based on their operational practices and populations served. Due to limited food preparation or handling, some meat, seafood, and produce departments in retail food stores may have been risk category 2. These facility types were included in this study because foodborne illness outbreaks have been associated with certain products sold in these departments.
C. Selection of Data Collectors
Approximately twenty FDA Regional Retail Food Specialists (Specialists) located throughout the nation, were chosen as the data collectors for this study. Each Specialist possessed technical expertise in retail food safety and a solid understanding of the operations inherent to each of the nine facility types chosen. In addition, Specialists were standardized in the consistent and uniform application of the control measures in the FDA Food Code and possessed a strong working knowledge of the foodborne illness risk factors. Selection of the Specialists as data collectors strengthened consistency and uniformity in assessing employee behaviors and practices within their work environment. In addition, the Specialists comprised a group within which implementation of the project could be easily coordinated and standardized.
D. Selection of Geographical Locations
The geographical distribution of Specialists throughout the country allowed for a broad sampling of establishments throughout all regions of the U.S. The choice of data collection locations, therefore, was based on the Specialists' geographical areas of responsibility and provided a reasonably convenient design for estimating national risk-related behaviors and practices.
An improved design for measuring trends within the retail food industry would be one based on probability sampling of the whole nation in which the number of establishments inspected within any given location would be related to the volume of retail food consumed within that location. This would have required the development of comprehensive establishment lists for randomly selected locations around the country and excessive travel which would have been cost-prohibitive and eliminated other vital work by FDA.
E. Selection of Establishments Using Comparison Set Establishment Lists
For the 1998 data collection period, each Specialist developed 5 Comparison Set Establishment Lists for each of the facility types. In most cases, each comparison set list was comprised of between 10 and 20 establishments located in a geographical area. For a few facility types, particularly nursing homes and hospitals, the number of establishments within a designated geographical area was limited. For these facility types, a comparison set list may have included as few as four establishments. Establishments were placed on each list in alphabetical order. In order to maintain data reliability and to ensure confidentiality of the selected establishments, the comparison set lists, as well as the inspectional observations, were retained in a central database by number rather than by establishment name or location.
Table 5 provides an illustration of a hypothetical Comparison Set Establishment List.
|FDA Specialist||Jane Doe|
|Facility Type||Fast Food|
|Establishment Risk Category||3|
|Comparison Set List Number||List 1 of 5|
|Note: If a facility is randomly chosen, but not inspected, note the reason in the Notes section at the bottom of the page.|
|Facility Name||Facility Address||Phone #||(Yes or No)|
|Random # Chosen?||Inspected?|
|1. Anytime Food||1 Ocean Dr. , Ocean Park , IL||123-4561|
|2. Big Pizzas||23 Pizza Place , Pepperoni , IL||123-4562|
|3. Crazy Time Food||101 Broadway, Ocean Park , IL||123-4563||Yes||Yes|
|4. Delicious Eats||240 Baltic Avenue , Monopoly , IL||123-4564|
|5. Dig These Dogs||6437 Oak St. , Pepperoni , IL||123-4565|
|6. Hungry Horses||972 E. West St. , Ocean Park , IL||123-4566||Yes||Yes|
|7. Make Your Own Sandwich||1 Elm St. , Monopoly , IL||123-4567|
|8. Tasty Treats||567 Illinois Ave , Monopoly , IL||123-4568|
|9. Try R Food||1919 Park Place , Monopoly , IL||123-4569|
|10. Zesty Delights||8134 W. East St ,, Ocean Park , IL||123-4570||Yes||No|
1998 - Establishment #6 randomly selected and inspected.
2003 (1st Attempt) - Establishment #10 randomly selected but was closed for business.
2003 (2nd Attempt) - Establishment #3 randomly selected and inspected.
In order to maintain consistency between data collection periods, the Specialists used the 1998 Comparison Set Establishment Lists in 2003 and will use them again in 2008. Selection bias was prevented by using a random number table to choose the establishments that were to be inspected. For example, using the hypothetical Comparison Set Establishment List, the Hungry Horses establishment was selected and inspected in 1998. In 2003, Zesty Delights was selected at random but was not inspected because it had gone out of business. Thus, the Specialist randomly selected another establishment from the list - Crazy Time Food.
Only one establishment was inspected from each comparison set list during the data collection. In addition, an establishment on a comparison set list could only be selected once for inspection. For instance, if in 2003, a Specialist randomly-picked an establishment that had already been inspected in 1998, the Specialist would have had to draw another random number until an establishment on the comparison set list that had not been inspected was chosen.
F. Number of Inspections Conducted
For statistical purposes at least ninety inspections were needed for each facility type. At least 100 inspections per facility type were planned to allow for un expected difficulties. In 2003, a total of 926 inspections, consisting of 15,516 observations, were conducted by FDA Regional Retail Food Specialists. Based on the number of inspections planned, each Specialist had to inspect at least five establishments from each of the nine facility types for a total of forty-five inspections.
G. Data Collection Form
So that data could be collected for specific behaviors and practices associated with each foodborne illness risk factor, the data collection form used for this study was divided into subparts. For example, rather than capturing all the behaviors and practices related to the Inadequate Cooking risk factor under one data item and being unable to discern what particular behavior or practice was at risk, there were twelve different types of observations that could be made, each corresponding to its own data item.
The data collection form used in 1998 included forty-two individual data items sorted among the five foodborne illness risk factors and a sixth category, "Other," for the potential risks related toxic or unapproved chemicals. Each of the forty-two data items were based on the 1997 FDA Food Code for both data collection periods.
The Food Code has and will continue to be updated periodically during the ten-year span of the study. Some of the changes in the FDA Food Code relate to the original forty-two data items; others are new provisions used to address emerging food safety concerns. To capture data for these changes, an additional category, "Supplemental Data Items," was added to the data collection form in 2003. The requirements in the 2001 Food Code were used as the basis for the Supplemental Data Items.
The following Data Collection Form was used for each establishment that was inspected:
This form was drafted for the specific purpose of collecting data regarding the occurrence at the retail level of risk factors associated with foodborne illness outbreaks. It was/is not intended to serve as a comprehensive, Food Code-based inspection form for food establishments.
Baseline Data Collection Form
Food and Drug Administration, Division of Cooperative Programs
Baseline Data Collection Project
|Time In:||Time Out:||Inspector:|
|Data Collected During:|
|Certified Food Protection Manager:||YES NO|
|_____ 41 °F (5 °C) or _____45 °F (7 °C) or _____ 41 °F (5 °C) + 45 °F (7 °C) is the cold holding requirement for this jurisdiction.|
|IN||= Item found IN Compliance (IN Compliance marking must be based on actual observations)|
|OUT||= Item found Out of Compliance (Out of Compliance marking must be based on actual observations)|
|NO||= Not observable (NO marking is made when the data item is part of the establishment's operation or procedures, OR is seasonal and is not occurring at the time of the inspection)|
|NA||= Not applicable (NA marking is made when the data item is NOT part of the establishment's operation or procedures)|
** RISK FACTOR - FOODS FROM UNSAFE SOURCE **
|IN||OUT||A.||All food from Regulated Food Processing Plants/ No home prepared/canned foods|
|IN||OUT||NA||B.||All Shellfish from NSSP listed sources. No recreationally caught shellfish received or sold|
|IN||OUT||NA||NO||C.||Game, wild mushrooms harvested with approval of Regulatory Authority|
|STATUS||2.||Receiving / Sound Condition|
|IN||OUT||A.||Food received at proper temperatures/ protected from contamination during transportation and receiving/food is safe, unadulterated|
|IN||OUT||NA||NO||A.||Shellstock tags/labels retained for 90 days from the date the container is emptied|
|IN||OUT||NA||NO||B.||As required, written documentation of parasite destruction maintained for 90 days for Fish products|
|IN||OUT||NA||C.||CCP monitoring records maintained in accordance with HACCP plan when required|
** RISK FACTOR - INADEQUATE COOK**
|STATUS||4.||Proper Cooking Temperature Per Potentially Hazardous Food (PHF). (NOTE: Cooking temperatures must be taken to make a determination of compliance or non-compliance. Do not rely upon discussions with managers or cooks to make a determination of compliance or non-compliance. If one food item is found out of temperature, that PHF category must be marked as Out of Compliance.)|
|IN||OUT||NA||NO||A.||Raw shell eggs broken for immediate service cooked to 145 °F (63 °C) for 15 seconds. Raw shell eggs broken but not prepared for immediate service cooked to155 °F (68 °C) for 15 seconds|
|IN||OUT||NA||NO||B.||Comminuted Fish, Meats, Game animals cooked to 155 °F (68 °C) for 15 seconds|
|IN||OUT||NA||NO||C.||Roasts, including formed roasts, are cooked to 130 °F (54 °C) for 112 minutes or as Chart specified and according to oven parameters per Chart (NOTE: This data item includes beef roasts, corned beef roasts, pork roasts, and cured pork roasts such as ham).|
|IN||OUT||NA||NO||D.||Poultry; stuffed fish, stuffed meat, stuffed pasta, stuffed poultry, stuffed ratites, or stuffing containing fish, meat, poultry or ratites cooked to 165 °F (74 °C) for 15 seconds|
|IN||OUT||NA||NO||E.||Wild game animals cooked to 165 °F (74 °C) for 15 seconds|
|IN||OUT||NA||NO||F.||Raw animal foods cooked in microwave are rotated, stirred, covered, and heated to 165 °F (74 °C). Food is allowed to stand covered for 2 minutes after cooking|
|IN||OUT||NA||NO||G.||Pork, ratites, injected meats are cooked to 155 °F (68 °C) for 15 seconds. Specify product and temperature in the space below. (NOTE: Pork observed cooked between 145 °F (63 °C) and 155 °F (68 °C), would be marked OUT here, but marked IN under Supplemental Item 17A. Please make notes in the comment section.)|
|IN||OUT||NA||NO||H.||All other PHF cooked to 145 °F (63 °C) for 15 seconds|
|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|
** RISK FACTOR - IMPROPER HOLD **
LIMITATION OF GROWTH OF ORGANISMS OF PUBLIC HEALTH CONCERN
|STATUS||6.||Proper Cooling Procedure (NOTE: Record any temperature above 41 °F (5 °C) on blank lines. Production documents as well as statements from managers, person in charge (PIC), and employees, regarding the time the cooling process was initiated, may be used to supplement actual observations.)|
|IN||OUT||NA||NO||A.||Cooked PHF is cooled from 140 °F (60 °C) to 70 °F (21 °C) within 2 hours and from 140 °F (60 °C) to 41 °F (5 °C) or below within 6 hours|
|IN||OUT||NA||NO||B.||PHF (prepared from ingredients at ambient temperature) is cooled to 41 °F (5 °C) or below within 4 hours|
|IN||OUT||NA||NO||C.||Foods received at a temperature according to Law are cooled to 41 °F (5 °C) within 4 hours|
|STATUS||7.||Cold Hold (41 °F (5 °C)) (NOTE: For the purposes of this Baseline, 41 °F (5 °C) or below will be used as the criteria for assessing all PHF that are maintained/held cold.) If one product is found out of temperature the item is marked Out of Compliance.)|
|IN||OUT||A.||PHF is maintained at 41 °F (5 °C) or below, except during preparation, cooking, cooling or when time is used as a public health control. (Record products and temperatures in the space below.)|
|STATUS||8.||Hot Hold (140 °F (60 °C))|
|IN||OUT||NA||NO||A.||PHF is maintained at 140 °F (60 °C) or above, except during preparation, cooking, or cooling or when time is used as a public health control. (NOTE: Products held between 135 °F (57 °C) and 140 °F (60 °C) should be marked OUT in 8A, but IN under supplemental item number 18A. Record actual product and measured temperatures in the space below.)|
|IN||OUT||NA||NO||B.||Roasts are held at a temperature of 130 °F (54 °C) or above|
|IN||OUT||NA||NO||A.||Ready-to-eat PHF held for more than 24 hours is date marked as required (prepared on-site)|
|IN||OUT||NA||NO||B.||Discard RTE PHF and/or opened commercial container exceeding 7 days at ≤ 41 °F (5 °C) or 4 days at ≤ 45 °F (7 °C)|
|IN||OUT||NA||NO||C.||Opened Commercial container of prepared ready-to-eat PHF is date marked as required|
|IN||OUT||NA||NO||D.||When time only is used as a public health control, food is cooked and served within 4 hours as required|
** RISK FACTOR - CONTAMINATED EQUIPMENT **
PROTECTION FROM CONTAMINATION
|STATUS||10.||Separation / Segregation / Protection|
|IN||OUT||NA||NO||A.||Food is protected from cross contamination by separating raw animal foods from raw ready-to-eat food and by separating raw animal foods from cooked ready-to-eat food|
|IN||OUT||NA||NO||B.||Raw animal foods are separated from each other during storage, preparation, holding, and display|
|IN||OUT||C.||Food is protected from environmental contamination - critical items|
|IN||OUT||NA||NO||D.||After being served or sold to a consumer, food is not reserved|
|STATUS||11.||Food-Contact Surfaces (NOTE: This item will require some judgment to be used when marking this item IN or OUT of compliance. This item should be marked Out of Compliance if observations are made that supports a pattern of non-compliance with this item. One dirty utensil, food contact surface or one sanitizer container without sanitizer would not necessarily support an Out of Compliance mark. You must provide notes concerning an Out of Compliance mark on this item.)|
|IN||OUT||A.||Food-contact surfaces and utensils are clean to sight and touch and sanitized before use|
** RISK FACTOR - POOR PERSONAL HYGIENE **
|STATUS||12.||Proper, Adequate Handwashing|
|IN||OUT||A.||Hands are clean and properly washed when and as required|
|STATUS||13.||Good Hygienic Practices|
|IN||OUT||NO||A.||Food Employees eat, drink, and use tobacco only in designated areas / do not use a utensil more than once to taste food that is sold or served / do not handle or care for animals present. Food employees experiencing persistent sneezing, coughing, or runny nose do not work with exposed food, clean equipment, utensils, linens, unwrapped single-service or single- use articles|
|STATUS||14.||Prevention of Contamination From Hands|
|IN||OUT||NA||NO||A.||Employees do not contact exposed, ready-to-eat food with their bare hands. (NOTE: In determining the status of this data item, an assessment of alternative methods when otherwise approved is to be made to determine implementation in accordance with the guidelines contained in Annex 3, 2001 Food Code, page 289.)|
|IN||OUT||A.||Handwash facilities conveniently located and accessible for employees|
|IN||OUT||B.||Handwash facilities supplied with hand cleanser / sanitary towels / hand drying devices|
** RISK FACTOR - OTHER **
|IN||OUT||NA||A.||If used, only approved food or color additives. Sulfites are not applied to fresh fruits and vegetables intended for raw consumption|
|IN||OUT||B.||Poisonous or toxic materials, chemicals, lubricants, pesticides, medicines, first aid supplies, and other personal care items are properly identified, stored and used|
|IN||OUT||NA||C.||Poisonous or toxic materials held for retail sale are properly stored|
(NOTE: The following items will be included as part of FDA's 2003 Baseline. These are additional items to the original 42 data item (contained in Section 1 - 16) that were assessed as part of the original baseline.)
|STATUS||17.||Proper Cooking Temperature (Supplement to Item 4G)|
|IN||OUT||NA||NO||A.||Pork is cooked to 145 °F (63 °C) or above for 15 seconds. (NOTE: Final cooking temperatures of Pork Roasts are recorded under data item 4C.)|
|IN||OUT||NA||NO||B.||Ratites and injected meats are cooked to 155 °F (68 °C) for 15 seconds|
|STATUS||18.||Hot Hold (135 °F (57 °C)) - (Supplement to Item 8A)|
|IN||OUT||NA||NO||A.||PHF is maintained at 135 °F (57 °C) or above, except during preparation, cooking, or cooling or when time is used as a public health control. (NOTE: Products held between 135 °F (57 °C) and 140 °F (60 °C) should be marked OUT in 8A. Record actual product and measured temperatures.)|
|STATUS||19.||Employee Health Policy|
|IN||OUT||A.||Facility has a written policy that is consistent with 2-201 of the Food Code for excluding and restricting employees on the basis of their health and activities as they relate to diseases that are transmissible through food. Written policy includes a statement regarding employee responsibility to notify management of symptoms and illnesses identified in the Food Code.|
|IN||OUT||NA||NO||A.||When packaged in a food establishment, juice is treated under a HACCP Plan to reduce pathogens or be labeled as specified in the Food Code.|
|STATUS||21.||Cooling - Raw Shell Eggs|
|IN||OUT||NA||NO||A.||After receiving, raw shell eggs are immediately placed under refrigeration that maintains ambient air temperature of 45 °F (7 °C) or less.|
|STATUS||22.||Cold Holding - Raw Shell Eggs|
|IN||OUT||NA||NO||A.||After receipt, raw shell eggs are stored in refrigerated equipment that maintains ambient air temperature of 45 °F (7 °C) or less.|
|STATUS||23.||Food & food preparation for highly susceptible populations|
|(NOTE: These items pertain specifically to those facilities that serve Highly Susceptible Populations as defined in the Food Code. Establishments would include such facility types as Hospitals, Nursing Homes and Elementary Schools.)|
|IN||OUT||NA||NO||A.||Prepackaged juice/beverage containing juice with a warning label (21 CFR, Section 101.17(g)) not served.|
|IN||OUT||NA||NO||B.||Pasteurized eggs or egg products substituted for raw shell eggs in preparation of foods that are not cooked to minimum required temperatures, (specified in Section 4.0 of this Baseline Form), unless cooked to order & immediately served; broken immediately before baking and thoroughly cooked; or included as an ingredient or a recipe supported by a HACCP plan that controls Salmonella Enteritidis.|
|IN||OUT||NA||NO||C.||Raw or partially cooked animal food and raw seed sprouts not served.|
The following is the DATA COLLECTION FORM REFERENCE SHEET which shows the applicable Food Code sections under each individual data item:
|Risk Factor |
FOODS FROM UNSAFE SOURCES
|Risk Factor |
1. Approved Source
Data Item - 1A
3-201.11* Compliance with Food Law
3-201.12* Food in A Hermetically Sealed Container.
3-201.13* Fluid Milk and Milk Products
Data Item - 1B
3-201.15* Molluscan Shellfish
3-202.18* Shellstock Identification
Data Item - 1C
3-201.16* Wild Mushrooms
3-201.17* Game Animals
4. Proper Cooking Temperature per PHF
Data Item - 4A
3-401.11(A)(1)(a)* Raw Animal Foods
3-401.11(A)(2)* Raw Animal Foods
Data Item - 4B
3-401.11(A)(2)* Raw Animal Foods
Data Item - 4C
3-401.11(B)(1)(2)* Raw Animal Foods
Data Item - 4D
3-401.11(A)(3)* Raw Animal Foods
Data Item - 4E
3-401.11(A)(3)* Raw Animal Foods
Data Item - 4F
3-401.12* Microwave Cooking
Data Item - 4G
3-401.11(A)(2)* Raw Animal Foods
Data Item - 4H
3-401.11(A)(1)(b)* Raw Animal Foods
2. Receiving/Sound Condition
Data Item - 2A
3-202.15* Package Integrity
3-101.11* Safe, Unadulterated, and Honestly Presented
Data Item - 3A
3-202.18* Shellfish Identification
3-203.12* Shellfish Maintaining Identification
Data Item - 3B
3.402.11* Parasite Destruction
3.402.12* Records, Creation and Retention
Data Item - 3C
3-502.12* Reduced Oxygen Packaging, Criteria
8-103.12* Conformance with Approved Procedures
5. Rapid Reheating for Hot Holding
Data Item 5A
3-403.11(A)* Reheating for Hot Holding
Data Item 5B
3-403.11(B)* Reheating for Hot Holding - Microwave
Data Item 5C
3-403.11(C)* Reheating for Hot Holding - Commercially Processed RTE Food
Data Item 5D
3-403.11(E)* Reheating for Hot Holding - Remaining sliced portions roasts Of beef
|Risk Factor |
Limitation of Growth of Organisms
of Public Health Concern
|Risk Factor |
Limitation of Growth of Organisms
of Public Health Concern
6. Proper Cooling Procedure
Data Item 6A
3-501.14(A)* Cooling - Cooked PHF
Data Item 6B
3-501.14(B)* Cooling - PHF prepared from ingredients at ambient temperature
Data Item 6C
3-501.14(C)* Cooling - PHF receipt of foods allowed at >41 °F (5 °C) during shipment
Data Item 9A
3-501.17(A)(1)(2)* Ready-to-Eat, PHF, Date Marking - On-premises Preparation
Data Item 9B
3-501.18* Ready-to-Eat, PHF, Disposition
Data Item 9C
3-501.17(C)* Ready-to-Eat, PHF, Date Marking
Data Item 9D
3-501.19* Time as a Public Health Control
7. Cold Hold (41 °F (5 °C))
Data Item 7A
3-501.16(B)* PHF, Hot and Cold Holding
8. Hot Hold (140 °F (60 °C))
Data Item 8A
3-501.16(A)* PHF, Hot and Cold Holding
Data Item 8B
3-501.16(A)* PHF, Hot and Cold Holding
|Risk Factor |
Protection from Contamination
|Risk Factor |
POOR PERSONAL HYGIENE
10. Separation / Segregation /Protection
Data Item 10A
3-302.11(A)(1)* Packaged and Unpackaged Food - Separation, Packaging, and Segregation
Data Item 10B
3-302.11(A)(2)* Packaged and Unpackaged Food - Separation, Packaging, and Segregation
Data Item 10C
3-302.11(A)(4-6)* Packaged and Unpackaged Food - Separation, Packaging, and Segregation
3-304.11(B)* Food Contact with Equipment and Utensils
Data Item 10D
3-306.14(A)(B)* Returned Food, Reservice or Sale
12. Proper, Adequate Handwashing
Data Item 12A
2-301.11* Clean Condition
2-301.12* Cleaning Procedure
2-301.14* When to Wash
2-301.15* Where to Wash
13. Good Hygiene Practices
Data Item 13A
2-401.11* Eating, Drinking, or Using Tobacco
2-401.12* Discharges from the Eyes, Nose and Mouth
2-403.11* Handling Prohibition - Animals
3-301.12* Preventing Contamination when Tasting
14. Prevention of Contamination from Hands
Data Item 14A
3-301.11* Preventing Contamination from Hands
11. Food Contact Surfaces
Data Item 11A
4-601.11(A) & (B)* Equipment, Food Contact Surfaces and Utensils
4-602.11* Equipment Food-Contact Surfaces and Utensils - Frequency
4-701.10* Sanitization of Equipment and Utensils - Food Contact Surfaces and Utensils
4-702.11* Sanitization of Equipment and Utensils - Before Use After Cleaning
15. Handwash Facilities
Data Item 15A
5-203.11* Handwashing Lavatory-Numbers and Capacity
5-204.11* Handwashing Lavatory-Location and Placement
5-205.11* Using a Handwashing Lavatory-Operation and Maintenance
Data Item 15B
6-301.11 Handwashing Cleanser, Availability
6-301.12 Hand Drying Provision
|Risk Factor |
Data Item 16A
3-302.14* Protection from Unapproved Additives
Data Item 16B
7-101.11* Identifying Information, Prominence-Original Containers
7-102.11* Common Name-Working Containers
Operational Suppliers and Applications
7-202.11* Restriction-Presence and Use
7-202.12* Conditions of Use
7-203.11* Poisonous or Toxic Material Containers - Prohibitions
7-204.11* Sanitizers, Criteria-Chemicals
7-204.12* Chemicals for Washing Fruits and Vegetables
7-204.13* Boiler Water Additives, Criteria
7-204.14* Drying Agents, Criteria
7-205.11* Incidental Food Contact, Criteria-Lubricants
7-206.11* Restricted Use Pesticides, Criteria
7-206.12* Rodent Bait Stations
7-206.13* Tracking Powders, Pest Control and Monitoring
7-207.11* Restriction and Storage-Medicines
7-207.12* Refrigerated Medicines, Storage
7-208.11* Storage-First Aid Supplies
7-209.11* Storage-Other Personal Care Items
Data Item 16C
Stock and Retail Sale of Poisonous or Toxic Material
7.301.11* Separation-Storage and Display
|SUPPLEMENTAL ITEMS||SUPPLEMENTAL ITEMS|
17. Proper Cooking Temperature (supplement to 4G - 2001 FDA Food Code)
Data Item 17A
3-401.11(A)(1)* Raw Animal Foods (pork)
Data Item 17B
3-401.11(A)(2)* Raw Animal Foods (ratites and
23. Food & Food Preparation for Highly Susceptible Populations - 2001 FDA Food Code
Data Item 23A
3-801.11(A)(2)* Prohibited Foods
Data Item 23B
3-801.11(B)* Prohibited Foods
3-801.11(E)* Prohibited Foods
Data Item 23C
3-801.11(D)* Prohibited Foods
18. Hot Hold (135° F) (Supplement to 8A - 2003 Supplement to the 2001 FDA Food Code)
Data Item 18A
3-501.16(A)(1)* PHF, Hot and Cold Hold
19. Written Employee Health Policy (NOTE: 2001 FDA Food Code does not require written policy)
Data Item 19A
2-201.11 Responsibility of Person in Charge
2-201.12* Exclusions and Restrictions
2-201.13 Removal of Exclusions and Restrictions
2.201.14* Responsibility of a Food Employee or an Applicant to Report to the Person in Charge
2-201.15* Reporting by the Person in Charge
20. Treating Juice - 2001 FDA Food Code
Data Item 20A
3-404.11 Treating Juice
21. Cooling Raw Shell Eggs - 2001 Food Code
Data Item 21A
22. Cold Holding - Raw Shell Eggs - 2001 FDA Food Code
Data Item 22A
3-501.16(B) Hot and Cold Holding
H. Data Collection Procedure
Specialists conducted unannounced, non-regulatory inspections of the selected establishments. A representative from the state, county, or city agency having regulatory oversight over the establishments may have accompanied a Specialist. When conditions in the establishments merited regulatory actions, the accompanying state or local representative could intervene to ensure appropriate corrective actions were taken. If a state, county, or city representative was not accompanying a Specialist and conditions warranted regulatory action, the regulatory authority was contacted.
Quantitative measurements were made using various equipment such as calibrated thermocouples, heat-sensitive tape, and maximum registering stem thermometers. For certain data items (see data collection form), visual observations were supplemented by asking questions of food workers and/or managers.
Using the 1997 FDA Food Code as a basis for the original forty-two individual data items and the 2001 FDA Food Code/2003 Food Code Supplement for the Supplemental data items, the Specialists determined whether the observations made of the employee food safety practices or behaviors were IN Compliance, Out of Compliance, Not Observed, or Not Applicable. An observation is based on an evaluation of one or more occurrences of a data item at an establishment. If all observed occurrences are IN Compliance, the data item is marked "IN". If any observed occurrence is Out of Compliance, then the data item is marked "OUT".
- IN meaning that the observation was IN COMPLIANCE with applicable FDA Food Code provisions;
- OUT meaning that the observation was OUT OF COMPLIANCE with applicable FDA Food Code provisions. An explanation of the observation was provided in the comment sections on the data collection form;
- N.O. meaning the data item was NOT OBSERVED during the inspection. The N.O. notation was used when a data item was a usual practice in the food service operation, but the practice was not observed during the time of the inspection. For example, if a restaurant that seasonally serves shellfish was selected for the study but the inspection occurred during non-shellfish season, then the applicable data item was marked N.O.; or
- N.A. meaning the data item was NOT APPLICABLE. The N.A. notation was used when a data item was not part of the food service operation. For example, if a seafood department that conducts no cooking was selected for the study, then all data items pertaining to cooking were marked N.A.
The Specialists were provided specific instructions for using the four marking options for each of the data items. Not all four marking options were available for every individual data item. For instance, in the case of cold holding, all establishments that were included in the data collection held PHF cold. As a result, the "not observed" (N.O.) and "not applicable" (N.A.) marking options were inappropriate given that an observation for cold holding was not only applicable in every case, but was also observable during every inspection.
The use of the "not observed" (N.O.) and "not applicable" (N.A.) as options for determining the status of individual data items was a critical component for attaining a meaningful performance indicator. For example, if the only options for marking compliance status were IN Compliance and Out of Compliance, then the default option for data items that did not apply to an operation would have been IN Compliance. If this were the case, the overall IN Compliance measurement for the establishment would have been higher than what was documented by actual observation of the food safety practice or employee behavior and would have been an over-estimate.
Likewise, for data items that did apply to an establishment's operation, but were not observed during the inspection, the default marking option would have been IN Compliance. Again, the overall IN Compliance measurement for the establishment would have been higher than what was documented by actual observation of the food safety practice or employee behavior and would have been an over-estimate.
The Specialists were provided a copy of a software program customized to store and analyze the data collected. Specialists entered the data into a database and conducted a series of quality assurance checks to verify the accuracy of the information. The data from each Specialist's software files was sent to FDA headquarters for entry into a central database. Before analyzing the data, an additional quality assurance review of the data was conducted to ensure reporting consistency within the established project design. FDA/CFSAN/ Division of Mathematics performed the statistical analysis of the data.
I. Average Time Per Data Collection
Many regulatory agencies planning to conduct similar foodborne illness risk factor studies within their jurisdictions have requested information on data collection time for each of the facility types. During this data collection, FDA tracked the actual time spent in each of the inspected establishments. Table 6 presents the average data collection time, in minutes, for each of the facility types. Travel time and off-site report preparation were not included in the FDA time assessment.
|Facility Type||Average Inspection Time |
|FAST FOOD RESTAURANTS||87|
|FULL SERVICE RESTAURANTS||133|
|MEAT & POULTRY||48|