FDA Logo U.S. Food and Drug AdministrationCenter for Food Safety and Applied Nutrition
U.S. Department of Health and Human Services
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CFSAN/Office of Compliance
September 14, 2004

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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)

Table of contents

III. RESULTS AND DISCUSSION
Restaurants


RESTAURANTS
FAST FOOD
RESULTS AND DISCUSSION

A. Percent of observations found Out of Compliance for each RISK FACTOR

Restaurants - FAST FOOD
Figure FF-1
PERCENT (%) of OBSERVATIONS found
Out of Compliance for each RISK FACTOR

Bar graph of the Data table below

FOODBORNE ILLNESS RISK FACTOR # OUT Total Obs.
(IN & OUT)
% OUT
Improper Holding/Time & Temperature 180 432 41.7%
Poor Personal Hygiene 165 529 31.2%
Other/Chemical 34 120 28.3%
Contaminated Equipment/Protection from Contamination 95 434 21.9%
Inadequate Cooking 17 186 9.1%
  Food From Unsafe Sources 5 216 2.3%

Discussion for Figure FF-1

Failure to control product holding temperatures and times was the risk factor with the highest Out of Compliance percentage. Poor personal hygiene, chemical contamination, and contaminated equipment/protection from contamination also had notable Out of Compliance percentages. Management systems that were implemented to ensure foods were adequately cooked and from safe sources appeared to be effective when compared to the other risk factors evaluated during this data collection period.

B. Percent of observations found Out of Compliance for each INDIVIDUAL DATA ITEM that comprises a risk factor

For fast food restaurants, the foodborne illness risk factors most in need of attention and their corresponding Out of Compliance percentages are:

Figures FF-2 thru FF-4 provide a breakdown of each of these risk factors into data items that represent specific food preparation procedures and employee behaviors in need of attention. These figures provide insight into the relative strengths and weaknesses of the food safety management systems in place in fast food restaurants to control each of the risk factors during the 2003 data collection.

The Out of Compliance percentage noted for the other/chemical risk factor was attributed to one specific data item that warrants attention. A summary of the results of the Out of Compliance observations for the identification, storage, and use of chemicals/toxics data item will be presented.

In addition, the inadequate cooking risk factor had one data item of interest. The results for cooking comminuted fish/meat/game animals will also be presented.

Restaurants - FAST FOOD
Figure FF-2
IMPROPER HOLDING/TIME AND TEMPERATURE
PERCENT (%) of OBSERVATIONS found
Out of Compliance for each DATA ITEM

Bar graph of the Data table below

DATA ITEM # OUT Total Obs.
(IN & OUT)
% OUT
Commercially-processed, RTE, PHF date marked 38 66 57.6%
PHF held cold at 41 °F or below 61 108 56.5%
RTE, PHF date marked after 24 hours 24 59 40.7%
PHF held hot at 140 °F or above289429.8%
RTE, PHF discarded after 4 days/45 °F or 7 days/41 °F54311.6%
* When time only is used as a public health control,
food is cooked and served within 4 hours*
4*18**
* Foods received at temperatures according to Law are
cooled to 41 °F within 4 hours.
2*14**
* PHF cooled to 70 °F in 2 hours/41 °F in total of 6 hours*10*12**
* PHF (prepared from ingredients at ambient temperature)
is cooled to 41 °F or below within 4 hours*
5*12**
* Roasts are held at a temperature of 130 °F or above3*6**

* These five remaining Improper Holding/Time & Temperature Data Items do not appear in
Figure FF-2 due to a low number of total observations (obs.)

Discussion for Figure FF-2

For the improper holding/time and temperature risk factor, there is a need to review food safety systems related to:

Date Marking

Date marking of refrigerated ready-to-eat, PHF is an important food safety system component designed to promote proper food rotation and limit the growth of Listeria monocytogenes during cold storage. Discarding ready-to-eat, PHF that has remained in cold storage beyond the parameters described in the Food Code prevents foods with a harmful level of Listeria monocytogenes from being served.

Cold and Hot Holding of PHF

Holding PHF at the proper cold or hot temperatures is critical to preventing the growth of bacteria. Equipment, processes, and monitoring procedures related to maintaining temperature control for PHF need to be assessed and corrective action should be taken if necessary.

Restaurants - FAST FOOD
Figure FF-3
POOR PERSONAL HYGIENE
PERCENT (%) of OBSERVATIONS found
Out of Compliance for each DATA ITEM

Bar graph of the Data table below

DATA ITEM # OUT Total Obs.
(IN & OUT)
% OUT
Proper, adequate handwashing56104 53.8%
Prevention of hand contamination5310550.5%
Good hygienic practices2310422.1%
Handwashing facility, cleanser/drying device1710815.7%
Handwashing facility, convenient/accessible1610814.8%

Discussion for Figure FF-3

The food safety procedures for the poor personal hygiene risk factor that are most in need of attention include:

Proper, Adequate Handwashing

Hands may become contaminated when employees engage in activities such as handling raw animal foods, using the restroom or handling soiled tableware. Hands are a common vehicle for the transfer of harmful bacteria and viruses to food products. Effective handwashing is one of the most important measures to minimize the contamination of food by employees. The lack of convenient handwashing facilities and/or supplies of hand cleanser/drying devices may contribute to a lack of proper handwashing. Reinforcing the importance of handwashing should be supported by a management system that includes proper employee training and monitoring of the frequency and effectiveness of handwashing practices.

Prevention of Hand Contamination

Handwashing alone may not prevent the transmission of pathogens to foods via hand contact, therefore, preventing bare hand contact with ready-to-eat foods is a major control measure for limiting the spread of harmful bacteria and viruses from the hands to ready-to-eat food. Reinforcing the importance of preventing bare hand contact with ready-to-eat foods should be supported by a management system that includes proper employee training and monitoring of practices to identify to what extent procedures are being followed.

Good Hygienic Practices

Proper hygienic practices by food employees minimize the possibility of transmitting disease through food. Employee practices such as eating, drinking, and smoking in food preparation areas and working while experiencing persistent coughing and sneezing must be prohibited. Elimination of these practices will help prevent the transfer of microorganisms to foods and food contact surfaces.

Restaurants - FAST FOOD
Figure FF-4
CONTAMINATED EQUIPMENT/PROTECTION FROM CONTAMINATION
PERCENT (%) of OBSERVATIONS found
Out of Compliance for each DATA ITEM

Bar graph of the Data table below

DATA ITEM # OUT Total Obs.
(IN & OUT)
% OUT
Surfaces/Utensils cleaned/sanitized5510850.9%
Raw/RTE foods, separated179118.7%
Protected from environmental contamination1710815.7%
Raw animal foods, separated681 7.4%
After being served, food is not re-served046 0.0%

Discussion for Figure FF-4

The food safety procedures for contaminated equipment/protection from contamination risk factor that are in most need of attention include:

Cleaning and Sanitizing

Proper cleaning and sanitization of food contact surfaces is an effective means of preventing cross-contamination. Many different procedures may be involved in the assessment of the management system related to this area. Evaluations should not be restricted to dishwashing procedures but should also include observations on how food preparation tables, cutting boards, and stand-in-place equipment such as slicers and mixers are cleaned and sanitized between uses.

The high Out of Compliance percentage for cleaning and sanitizing food contact surfaces and utensils indicates a weakness in fast food restaurant management systems designed to prevent cross-contamination.

Separation of Raw Animal Foods from Ready-to-Eat Foods

Raw animal foods are a potential source of contamination in any food operation. Storing raw animal foods above or in close proximity to ready-to-eat foods increases the potential for food to become contaminated. To prevent cross-contamination, raw animal foods should also be separated by species based on required minimum cooking temperatures. Required cooking temperatures are based on thermal destruction data and anticipated microbial load. These parameters may vary with different type of raw animal foods. Having organized storage systems that include designated areas for raw animal products will help prevent cross-contamination of foods.

Preventing cross-contamination between raw animal foods and ready-to-eat foods extends to the food preparation area. Designated separate food preparation areas should be provided for raw and ready-to-eat products. If common preparation areas must be used, then procedures must be in place to ensure proper cleaning and sanitizing between uses.

Discussion for the Other/Chemical Risk Factor
Table 15
Assessment of the Other/Chemical Category - FAST FOOD RESTAURANTS
Poisonous or Toxic Materials are Properly Identified, Stored, and Used
# Observations
OUT
TOTAL Observations
(IN & OUT)
% Observations
OUT
34 108 31.5%

All of the Out of Compliance observations relating to the other/chemical risk factor are attributed to one data item. The proper identification, storage, and use of cleaners, sanitizers, and other chemicals in fast food restaurants are in need of attention. Food safety procedures related to the identification, storage, and use of cleaners, sanitizers, and other chemicals need to be reviewed and revised, if necessary, to address any gaps in the program that may be contributing to the Out of Compliance observations for this data item.

Discussion for the Inadequate Cooking Risk Factor
Table 16
Assessment of the Inadequate Cooking Risk Factor
FAST FOOD RESTAURANTS
Comminuted Fish/Meats/Game Animals Cooked to 155 °F/15 seconds
# Observations
OUT
TOTAL Observations
(IN & OUT)
% Observations
OUT
8 50 16.0%

Cooking foods to temperatures that destroy pathogens is critical to reducing the risk of foodborne illness. The minimum internal product temperature and the time that this temperature must be maintained are dictated by the type of food product being cooked. Proper monitoring and control of cooking operations is central to an effective food safety management system in any establishment.

Of the fast food restaurants observed to be cooking comminuted (ground) meat/fish/game animals, 16% of these were found to be Out of Compliance. The large number of servings of these foods, prepared and sold by fast food restaurants, suggest that reducing the Out of Compliance percentage for this data item is an important public health concern.

 

C. Summary of foodborne illness RISK FACTORS and INDIVIDUAL DATA ITEMS in need of priority attention

Table 17
Restaurants - FAST FOOD
Summary of Foodborne Illness RISK FACTORS and
DATA ITEMS in Need of Priority Attention
FOODBORNE ILLNESS
RISK FACTOR
in need of Priority Attention
(From Section A)
INDIVIDUAL DATA ITEMS
in need of Priority Attention
(From Section B)
Improper Holding/
Time & Temperature
Commercially-processed RTE, PHF date marked
PHF held cold at 41 °F or below
RTE, PHF date marked after 24 hours
PHF held hot at 140 °F or above
Poor Personal Hygiene Proper, adequate handwashing
Prevention of hand contamination
Good hygienic practices
Other/Chemical Poisonous or toxic materials properly identified, store, and used
Contaminated Equipment/
Protection from
Contamination
Surfaces/Utensils cleaned/sanitized
Raw animal food separated from ready-to-eat foods
Inadequate Cooking Comminuted fish/meat/game animals cooked to
155 °F/15 seconds

 

RESTAURANTS
FULL SERVICE
RESULTS AND DISCUSSION

A. Percent of observations found Out of Compliance for each RISK FACTOR

Restaurants - Full Service
Figure FS-1
PERCENT (%) of OBSERVATIONS found
Out of Compliance for each RISK FACTOR

Bar graph of the Data table below

FOODBORNE ILLNESS RISK FACTOR # OUT Total Obs.
(IN & OUT)
% OUT
Improper Holding/Time & Temperature 300 470 63.8%
Poor Personal Hygiene 203 487 41.7%
Contaminated Equipment/Protection from Contamination 163 437 37.3%
Other/Chemical 38 124 30.6%
Inadequate Cooking 38 240 15.8%
  Food From Unsafe Sources 33 254 13.0%

 

Discussion for Figure FS-1

Failure to control product holding temperatures and times was the risk factor with the highest Out of Compliance percentage. Poor personal hygiene, contaminated equipment/protection from contamination, and chemical contamination also had notable Out of Compliance percentages. Management systems that were implemented to ensure foods were adequately cooked and from safe sources appeared to be effective when compared to the other risk factors evaluated during this data collection period.

B. Percent of observations found Out of Compliance for each INDIVIDUAL DATA ITEM that comprises a risk factor

For full service restaurants, the foodborne illness risk factors most in need of attention and their Out of Compliance percentages are:

Figures FS-2 thru FS-4 provide a breakdown of each of these risk factors into data items that represent specific food preparation procedures and employee behaviors in need of attention. These figures provide insight into the relative strengths and weaknesses of the food safety management systems in place in full service restaurants to control each of the risk factors during the 2003 data collection.

The other/chemical, inadequate cooling, and food from unsafe sources risk factors all had high IN Compliance percentages. There were, however, a few data items within each of these risk factors that are in need of attention. Information for these data items will be presented as part of the discussion.

Restaurants - FULL SERVICE
Figure FS-2
IMPROPER HOLDING/TIME AND TEMPERATURE
PERCENT (%) of OBSERVATIONS found
Out of Compliance for each DATA ITEM

Bar graph of the Data table below

DATA ITEM # OUT Total Obs.
(IN & OUT)
% OUT
PHF held cold at 41 °F or below 77 99 77.8%
PHF cooled to 70 °F in 2 hours/41 °F in total of 6 hours 34 44 77.3%
RTE, PHF date marked after 24 hours 69 93 74.2%
Commercially-processed, RTE, PHF date marked436764.2%
PHF held hot at 140 °F or above428748.3%
RTE, PHF discarded after 4 days/45 °F or 7 days/41 °F163644.4%
* Foods received at temperatures according to Law are
cooled to 41 °F within 4 hours.*
6*18**
* PHF (prepared from ingredients at ambient temperature)
is cooled to 41 °F or below within 4 hours*
7*16**
* Roasts are held at a temperature of 130 °F or above*3*5**
* When time only is used as a public health control,
food is cooked and served within 4 hours*
3*5**

* These four remaining Improper Holding/Time & Temperature Data Items do not appear in
Figure FS-2 due to a low number of total observations (obs.)

Discussion for Figure FS-2

For the improper holding/time and temperature risk factor, there is a need to review food safety systems related to:

Cold and Hot Holding of PHF

Holding PHF at the proper cold or hot temperatures is critical to preventing the growth of bacteria. Equipment, processes, and monitoring procedures related to maintaining temperature control for PHF need to be assessed and corrective action should be taken if necessary.

Cooling of PHF

Safe cooling requires the removal of heat from foods quickly enough to prevent the growth of spore-forming pathogens. Foodservice directors and managers within full service restaurants need to ensure their practices and procedures are capable of rapidly cooling PHF.

The total number of observations for cooling was substantially less than the total number of observations for other data items. The time of day the data was collected and the length of the time available to spend in a facility were significant factors limiting the number of observations of cooling. For example, as much as six hours may be required on site to document compliance with the Food Code critical limits for cooling.

Date Marking

Date marking of refrigerated ready-to-eat, PHF, such as deli meats, meat or seafood salads, and soft cheeses, is an important food safety system component designed to promote proper food rotation and limit the growth of Listeria monocytogenes during cold storage. Discarding ready-to-eat, PHF foods that has remained in cold storage beyond the parameters described in the Food Code prevents foods with a harmful level of Listeria monocytogenes from being served.

Restaurants - FULL SERVICE
Figure FS-3
POOR PERSONAL HYGIENE
PERCENT (%) of OBSERVATIOS found
Out of Compliance for each DATA ITEM

Bar graph of the Data table below

DATA ITEM # OUT Total Obs.
(IN & OUT)
% OUT
Proper, adequate handwashing729972.7%
Prevention of hand contamination539357.0%
Good hygienic practices339734.0%
Handwashing facility, convenient/accessible239923.2%
Handwashing facility, cleanser/drying device229922.2%

Discussion for Figure FS-3

The food safety procedures for the poor personal hygiene risk factor that are most in need of attention include:

Proper, Adequate Handwashing

Hands may become contaminated when employees engage in activities such as handling raw animal foods, using the restroom or handling soiled tableware. Hands are a common vehicle for the transfer of harmful bacteria and viruses to food products. Effective handwashing is one of the most important measures to minimize the contamination of food by employees. The lack of convenient handwashing facilities or supplies of hand cleanser/drying devices may contribute to a lack of proper handwashing. Reinforcing the importance of handwashing should be supported by a management system that includes proper employee training and monitoring of the frequency and effectiveness of handwashing practices.

Prevention of Hand Contamination

Handwashing alone may not prevent the transmission of pathogens to foods via hand contact, therefore, preventing bare hand contact with ready-to-eat foods is a major control measure for limiting the spread of harmful bacteria and viruses from the hands to ready-to-eat food. Reinforcing the importance of preventing bare hand contact with ready-to-eat foods should be supported by a management system that includes proper employee training and monitoring of practices to identify to what extent procedures are being followed.

Good Hygienic Practices

Proper hygienic practices by food employees minimize the possibility of transmitting disease through food. Employee practices such as eating, drinking and smoking in food preparation areas and working while experiencing persistent coughing and sneezing must be prohibited. Elimination of these practices will help prevent the transfer of microorganisms to foods and food contact surfaces.

Restaurants - FULL SERVICE
Figure FS-4
CONTAMINATED EQUIPMENT/PROTECTION FROM CONTAMINATION
PERCENT (%) of OBSERVATIONS found
Out of Compliance for each DATA ITEM

Bar graph of the Data table below

DATA ITEM # OUT Total Obs.
(IN & OUT)
% OUT
Surfaces/Utensils cleaned/sanitized569956.6%
Raw/RTE foods, separated459646.9%
Protected from environmental contamination359935.4%
Raw animal foods, separated249425.5%
After being served, food is not re-served3496.1%

Discussion for FS-4

The food safety procedures for contaminated equipment/protection from contamination risk factor that are most in need of attention include:

Cleaning and Sanitizing

Proper cleaning and sanitization of food contact surfaces is an effective means of preventing cross-contamination. Many different procedures may be involved in the assessment of the management system related to this area. Evaluations should not be restricted to dishwashing procedures but should also include observations on how food preparation tables, cutting boards, and stand-in-place equipment such as slicers and mixers are cleaned and sanitized between uses.

The high Out of Compliance percentage for cleaning and sanitizing food contact surfaces and utensils indicates a weakness in full service restaurant management systems designed to prevent cross-contamination.

Separation of Raw Animal Foods from Ready-to-Eat Foods

Raw animal foods are a potential source of contamination in any food operation. Storing raw animal foods above or in close proximity to ready-to-eat foods increases the potential for food to become contaminated. To prevent cross-contamination, raw animal foods should also be separated by species based on required minimum cooking temperatures. Required cooking temperatures are based on thermal destruction data and anticipated microbial load. These parameters may vary with different type of raw animal foods. Having organized storage systems that include designated areas for raw animal products will help prevent cross-contamination of foods.

Preventing cross contamination between raw animal foods and ready-to-eat foods extends to the food preparation area. Designated separate food preparation areas should be provided for raw and ready-to-eat products. If common preparation areas must be used, then procedures must be in place to ensure proper cleaning and sanitizing between uses.

Protection from Environmental Contamination

Food that is inadequately packaged or contained in damaged packaging could become contaminated by microbes, dust, condensate waste, or chemicals. These contaminates may be introduced by other products or equipment stored in close proximity or by persons who are delivering, stocking or opening packages. Foodservice managers need to ensure that standard operating procedures are in place to protect food from environmental contamination from the moment it is received until served or sold to the consumer. Except during cooling, stored products should be covered or wrapped to prevent the entry of microbes and other contaminants.

Discussion for the Other/Chemical Risk Factor
Table 18
Assessment of the Other/Chemical Category
FULL SERVICE RESTAURANTS
Poisonous or Toxic Materials are Properly Identified, Stored, and Used
# Observations
OUT
TOTAL Observations
(IN & OUT)
% Observations
OUT
38 99 38.4%

All of the Out of Compliance observations relating to the other/chemical risk factor were attributed to one data item. The proper identification, storage, and use of cleaners, sanitizers, and other chemicals in full service restaurants are in need of attention. Food safety procedures related to the identification, storage, and use of cleaners, sanitizers, and other chemicals need to be reviewed and revised, if necessary, to address any gaps in the program that may be contributing to the Out of Compliance observations made of this data item.

Discussion for the Inadequate Cooking Risk Factor

Cooking foods to temperatures that destroy pathogens is critical to reducing the risk of foodborne illness. The minimum internal product temperature and the time that this temperature must be maintained are dictated by the type of food product being cooked. Proper monitoring and control of cooking operations is central to an effective food safety management system in any establishment.

 

Reheating of PHF

Table 19
Assessment of the Inadequate Cooking Risk Factor
FULL SERVICE RESTAURANTS
Poultry, Stuffed Fish, Meat, Pasta Cooked to 165 ºF (74 ºC) for 15 sec.
# Observations
OUT
TOTAL Observations
(IN & OUT)
% Observations
OUT
9 47 19.2%

 

 

Reheating of PHF

Table 20
Assessment of the Inadequate Cooking Risk Factor
FULL SERVICE RESTAURANTS
PHF Rapidly Reheated to 165 °F (74 °C)
for 15 sec. for Hot Holding
# Observations
OUT
TOTAL Observations
(IN & OUT)
% Observations
OUT
11 36 30.6%

It is important to properly reheat PHF that was initially cooked and cooled on premises and which is to be held hot prior to serving. Reheating these products to 165 °F (74 °C) for 15 seconds ensures that pathogens that may have contaminated the food after cooking are destroyed and are not given the opportunity to multiply during hot holding. Of the full service restaurants in which reheating of PHF for hot holding was observed, approximately 31% were found to be Out of Compliance.

Discussion for the Food from Unsafe Sources Risk Factor
Table 21
Assessment of the Food from Unsafe Sources Risk Factor
FULL SERVICE RESTAURANTS
Shellstock Tags Retained for 90 Days
# Observations
OUT
TOTAL Observations
(IN & OUT)
% Observations
OUT
13 19 68.4%

The overall IN Compliance percentage for data items that comprise the food from unsafe sources risk factor is high indicating effective management of this area. There is one exception to this general observation - retention of shellstock tags for 90 days.

It is important to note that this data item had only nineteen total observations. Of the observations made, thirteen were Out of Compliance. Data items with less than twenty total observations have generally not been singled out for discussion in this report. An exception is made here because only a minority of full service restaurants offered shellstock as a menu item. Therefore, one would not expect a large number of observations to be made of this item in full service restaurants.

Shellfish harvested from contaminated water can harbor harmful bacteria and viruses. Effective monitoring of shellfish sources must be continuous and involve all segments of the industry. Retention of shellstock tags for 90 days is not a direct contributing factor to the occurrence of foodborne illness. It is, however, an essential management practice that provides a means for conducting tracebacks to the harvest areas should a food-related illness or contamination be associated with shellstock.

 

C. Summary of foodborne illness RISK FACTORS and INDIVIDUAL DATA ITEMS in need of priority attention

Table 22
Restaurants - FULL SERVICE
Summary of Foodborne Illness RISK FACTORS and
DATA ITEMS in Need of Priority Attention
FOODBORNE ILLNESS
RISK FACTOR
in need of Priority Attention
(From Section A)
INDIVIDUAL DATA ITEMS
in need of Priority Attention
(From Section B)
Improper Holding/
Time & Temperature
PHF held cold at 41 °F or below
PHF cooled to 70 °F in 2 hours/41 °F in total of 6 hours
RTE, PHF date marked after 24 hours
Commercially-processed RTE, PHF date marked
PHF held hot at 140 °F or above
RTE, PHF discarded after 4 days/45 °F or 7 days/41 °F
Poor Personal Hygiene Proper, adequate handwashing
Prevention of hand contamination
Good hygienic practices
Handwashing facility, convenient/accessible
Handwashing facility, cleanser/drying device
Contaminated Equipment/
Protection from Contamination
Surfaces/Utensils cleaned/sanitized
Raw animal food separated from ready-to-eat foods
Prevention from environmental contamination
Raw animal foods separated from each other
Other/Chemical Poisonous or toxic materials properly identified, stored, and used
Inadequate Cooking PHF rapidly reheated to 165 °F/15 seconds for hot holding
Poultry, stuffed fish, meat, pasta cooked to 165 °F for 15 seconds
Food from Unsafe Sources Shellstock tags retained for 90 days
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