Part 1 - Summary of Changes - a "quick view" of the modifications
Part 2 - Amendments, Additions, Deletions to the Preface, Chapters 1-8 and the Annexes - actual language modifications
Part 3 - New Terms added to the Index to the Food Code
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IMPORTANT - Save this Supplement. It is intended to keep the 2005 Food Code up-to-date. Changes, additions, deletions, and format modifications listed herein constitute revisions to the 2005 Food Code effective upon issuance.
This guidance represents the Food and Drug Administration's (FDA) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public.
For public sale by:
U.S. Department of Commerce
Technology Administration
National Technical Information Service
5285 Port Royal Road, Springfield, VA 22161
(703) 605-6000 or 1-800-553-6847
(refer to report number PB2007-112622)
The Food and Drug Administration (FDA) is pleased to issue this Supplement to the 2005 Food Code (hereafter referred to as Supplement). This Supplement updates the 2005 Food Code to address several recommendations made by the 2006 Conference for Food Protection (CFP) with which the FDA, Centers for Disease Control and Prevention (CDC), and United States Department of Agriculture (USDA) concur. The changes contained in this Supplement reflect the current science and emerging food safety issues, and imminent health hazards related to food safety.
From 1993 through 2001, the complete Food Code was issued every two years. With the support of the CFP, FDA currently issues a new Food Code every 4 years. The next complete revision of the Food Code will be published in 2009. Until that time, this Supplement provides a means of incorporating several changes with which there is substantial concurrence among the federal agencies and the other stakeholders, to be incorporated into the Food Code. The Supplement ensures that the most current food safety provisions are available to agencies planning to initiate rule-making activities prior to 2009. This Supplement provides other users of the Food Code, such as educators, trainers, and the food service, retail food, and vending industries, with up-to-date information of how to best mitigate risk factors that contribute to foodborne illness.
While the recommendations of the 2006 CFP meeting provide the basis for the Food Code changes contained in this Supplement, not all recommendations of the 2006 CFP meeting were incorporated. Some recommendations require further consideration or research by one or more of the federal agencies. FDA anticipates that most of the 2006 CFP recommendations with which the federal agencies agree will be addressed in the 2009 Food Code.
The Supplement has been organized to facilitate the adoption of its provisions by federal, state, local, and tribal authorities. The Supplement is divided into 3 Parts:
Part 1 - Summary of Changes - a "quick view" of the modifications
Part 2 - Amendments, Additions, Deletions to the Preface, Chapters 1-8 and the Annexes - actual language modifications
Part 3 - New Terms added to the Index to the Food Code
For consistency, drafting conventions used in the Federal Register for announcing proposed changes to federal rules are used to announce changes found in the Supplement to the 2005 Food Code. The standard terms used to describe a change are:
Amend. "Amend" means that an existing Food Code provision has changed. Because it is an introductory term, it is always used with one of the following specific amendatory terms to precisely describe the change to the Food Code provision.
Amendatory Terms
Add - means a new provision has been inserted in the Food
Code.
Redesignate - means to modify a Food Code provision by reformatting the
text of the provision into a new structural nomenclature designation.
Remove - means an existing provision is being taken out of the Food
Code.
Revise - means an existing Food Code provision is replaced in part, or
in its entirety.
For example:
Amend § 4-204.110 to revise subparagraph (B)(1) and to add subparagraph (B)(3) to read as follows: [text of changed subparagraph and newly added subparagraph]
Modifications are organized by Food Code chapter and are identified by Section number and title, and the paragraph, (e.g., 9-101.11(A)) or subparagraph (e.g., 9-101.00(A)(1)) to which the change is made. The full text of a Section is provided only if necessary to provide the proper context. Using Chapter 3 as an example, a change is introduced as follows:
Chapter 3 Food
Amend § 3-202.11 to revise paragraph (D) to read as follows:
Specifications for Receiving
3-202.11 Temperature.*
[text of changed paragraph]
Using Annex 3 as an example, a change to the public health reasons in Chapter 4 is introduced as follows:
Annex 3 Public Health Reasons/Administrative Guidelines
4-202.15 Can Openers.
Amend Public Health Reason for § 4-202.15 to revise to read as follows:
[text of changed paragraph]
We encourage all jurisdictions to examine the level of food safety protection their current rules and implementation strategies provide and take the steps necessary to increase that level in light of the 2005 Food Code and its Supplement. The adoption and implementation of the Food Code in all jurisdictions is an important strategy for achieving uniform national food safety standards and for enhancing the efficiency and effectiveness of our nation's food safety system.
The Department of Health and Human Services (DHHS) and USDA, along with state, local, tribal and other federal government agencies and the food industry, share responsibility for ensuring that our food supply is safe. DHHS and USDA, in partnership with numerous others, will continue to take progressive steps to strengthen our nation's food safety system. We look forward to achieving uniform and effective standards of food safety for food service, retail stores, and other retail-level establishments nationwide.
IMPORTANT. This entire Supplement to the 2005 Food Code is intended to keep the 2005 Food Code up-to-date. Changes, additions, deletions, and format modifications listed herein constitute revisions to the 2005 Food Code effective upon issuance via web posting or hard copy release.
The amendments to the 2005 Food Code and its Annexes contained in the Supplement are summarized below. If an amendment relates directly to a recommendation of the Conference for Food Protection (CFP), the CFP issue number is provided in the parenthesis immediately after the summary entry.
Preface - No changes
Chapter 1 Definitions
1-201.10 (B)
Added the new term "Dealer", Replaced the word "dealer" with "dealer" in small
caps to distinguish it as a defined term
Revised the definitions for the terms "Food Establishment "and "Food Processing Plant" to accurately represent the function of each business type and how they may coexist within the same premises. (CFP Issue 2006-I-002)
Revised the definition of Potentially Hazardous Food (Time/Temperature Control for Safety Food) subparagraph (2)(a) by adding, "cut tomatoes" (CFP Issue 2006-III-005)
Chapter 2
2-101.11
Redesignated by creating ¶(A) and adding new ¶(B) specifying an alternative
that allows a single PIC to be responsible for multiple permitted food establishments co-located on a single food establishment premises, under certain conditions
2-201.13
Revised text from "may" to "shall" in the Code provision
Chapter 3
Replaced the word "dealer" with "dealer" in small caps to distinguish it as a defined term
3-202.17(A)(2)
Added "best if used by" (CFP Issue 2006-I-028)
3-202.18(A)
Amended to delete the words "and each" before the word "dealer"
3-203.12
Amended by revising a cross-reference in ¶ (A), deleting ¶ (B), adding new language in new ¶ (B), that requires recording of the date that a shellfish container is emptied, and adding new ¶ (C) that defines record
keeping requirements (CFP Issue 2006-I-027)
3-403.11; 3-501.12(A); 3-501.13 (A) and (B); and 3-501.14
Removed all uses and cross references to Subparagraph
3-501.16 (A)(2) that referenced 7°C (45°F) cold holding.
3-501.16
Removed subparagraphs (A)(2)(a) and (b) that referenced 5°C
(41°F) and 7°C (45°F) cold holding and deleted the reference to upgrading
refrigeration equipment within 5 years of adoption; Revised subparagraph (A)(2)
to specify a cold holding temperature of 41°F or less (CFP Issue 2006-I-033)
Added a new ¶ (C) that is an allowance for holding potentially hazardous food (time/temperature control for safety food) in specially designed dispensing equipment that maintain the safety of aseptically-packaged fluid foods when the equipment is manufactured and operated in conformance with the NSF/ANSI Standard No. 18 (CFP Issue # 2006-III-018).
3-501.17(A)
Removed subparagraphs (A) (1) and (2) that referenced 5°C
(41°F) and 7°C (45°F) cold holding and removed the reference to upgrading
refrigeration equipment within 5 years of adoption; Amended ¶ (A) to specify 41°F
or less for cold holding of food (CFP Issue 2006-I-033)
3-501.19
Revised subparagraphs 3-501.19(B)(3) and (C)(4)(b) by stating that
ready-to-eat food held using time only as the public health control can be
served at any temperature upon a consumer's request (CFP Issue 2006-I-036)
3-502.12(D)
Revised subparagraph (D)(2)(c) for cook chill and sous vides
processes, revised subparagraph (2)(d) to specify when bags are sealed and removed
subparagraph (2)(e)(i)-(ii) for storage times and temperatures and replaced it
with a new subparagraph (2)(e)(i)-(iv) to provide for additional options (CFP
Issue 2006-III-013)
Chapter 4
4-203.13
Revised language regarding the acceptable range of fresh hot
water sanitizing rinse pressure measuring device (CFP Issue 2006-I-022)
4-204.13
Added new ¶(E) and subparagraphs (E)(1) and (E)(2) (CFP
Issue # 2006-III-018)
4-204.111(B)(1)
Removed cross reference to Subparagraph
3-501.16 (A)(2) that referenced 7°C (45°F) cold holding.
4-501.113
Revised the tag line and the text regarding the acceptable
range of the flow pressure of the fresh hot water sanitizing rinse (CFP Issue
#2006-I-022)
Chapter 5 - No changes
Chapter 6 - No changes
Chapter 7 - No changes
Chapter 8 - No changes
Annex 1- No changes
Annex 2
Annex 3
Chapter 1 Statement of Application and Listing of Terms
1-201.10 (B)
Added language to describe how food establishments and food
processing plants within the same premises of a food establishment can conduct
business concurrently and the importance of operators being aware of the
applicable regulations.
Added information to the definition of Potentially Hazardous Food (Time-Temperature Control for Safety Food) to support the inclusion of specific food commodities by using Tables A and B
2-101.11, Assignment
Added a new second paragraph that addresses the conditions
under which a single person in charge may cover multiple licensed food
facilities under a single food establishment, during special circumstances
2-201
Revised paragraph 2 to provide criteria for compliance with
Subpart 2-201 in regards to PIC responsibility and regulatory authority
compliance assessment
2-201.12
Revised text of Employee Health Tables 1b and 2 to match
changes from "may" to "shall" in §2-201.13 in the codified text
2-201.13
Revised to match change from "may" to "shall" in §2-201.13 in
the codified text
3-203.12
Added three paragraphs to clarify when the 90-day period for
retaining shellfish tags begins
3-401.13
Revised hot holding temperature to (57°C) 135°F to match codified text
3-501.16
Added information regarding holding potentially hazardous
food (time/temperature control for safety food) in specially designed
dispensing equipment that maintain the safety of aseptically-packaged fluid
foods when the equipment is manufactured and operated in conformance with the
NSF/ANSI Standard No. 18 (CFP Issue # 2006-III-018)
Added rationale in regard to an exception for holding
PHF/TCS food and added new information on the historical record of the cold
holding temperature provisions to the end of the existing text
3-501.19
Added the rationale that ready-to-eat food held using time only
as the public health control can be served at any temperature upon a consumer's
request and added studies on "Consumer Handling Practices" and FDA in-house
laboratory experiments.
3-502.12
Added information to explain the four separate time-temperature storage
options available for food packaged using cook chill or sous vide packaging
without a variance using the growth parameters of the pathogens of concern as
the basis for limitations
4-204.13
Added new information on the revised standard for dispensing
equipment (CFP Issue # 2006-III-018)
5-204.11
Revised to clarify "convenient use" in regard to the location
and placement of handwash sinks
Annex 4 - No changes
Annex 5 - No changes
Annex 6 - No changes
Annex 7
Models Forms, Guides, and Other Aids
Form 1-D, Application for Bare Hand Contact Procedure
Deleted the first bullet under #9 because vaccination
of food employees has not been found to be a cost effective means of
controlling Hepatitis A virus as a general rule for all
food establishments. The form is being edited to match codified text.
Form 3-A, Food Establishment Inspection Report Form
Revised Items #2, #3, #7, and #8 to reflect changes to Subpart
2-2 in the 2005 Food Code (CFP 2006-II-030)
Guide 3-B, Food Code References for Risk Factors/Interventions
and Good Retail Practices Specified on the Food Establishment Inspection Report
Revised Items #2, #3, and #45 to reflect changes in the
2005 Food Code (CFP 2006-II-030)
Guide 3-C, Instructions for Marking the Food Establishment Inspection Report
Revised C.1. A of the marking instructions to be consistent
with the new ¶(A) and ¶(B) in §2-101.11; updated C.1.B of the marking
instructions to specify applicable code section §2-102.20
Amend § 1-201.10 to add to paragraph (B) the following defined term:
Applicability and Terms Defined
1-201.10 Statement of Application and Listing of Terms.
(B) Terms Defined.
Dealer.
"Dealer" means a person who is authorized by a shellfish control authority for the activities of shellstock shipper, shucker-packer, repacker, reshipper, or depuration processor of molluscan shellfish according to the provisions of the National Shellfish Sanitation Program.
Amend §1-201.10 to revise in paragraph (B)the word "dealer" to read "dealer" in small caps in the following defined terms:
Applicability and Terms Defined
1-201.10 Statement of Application and Listing of Terms.
(B) Terms Defined.
Certification number.
"Certification number" means a unique combination of letters and numbers assigned by a shellfish control authority to a molluscan shellfish dealer according to the provisions of the National Shellfish Sanitation Program.
Shellfish control authority.
"Shellfish control authority" means a state, federal, foreign, tribal, or other government entity legally responsible for administering a program that includes certification of molluscan shellfish harvesters and dealers for interstate commerce.
Amend §1-201.10 to revise in paragraph (B) the following defined terms to read as follows:
Food Establishment.
Food Processing Plant.
"Food processing plant" means a commercial operation that manufactures, packages, labels, or stores food for human consumption, and provides food for sale or distribution to other business entities such as food processing plants or food establishments.
Amend §1-201.10 to revise ¶ (B) for the definition of Potentially Hazardous Food (Time/Temperature Control for Safety Food) subparagraph (2)(a) to add "cut tomatoes", to read as follows:
Potentially Hazardous Food (Time/Temperature Control for Safety Food).
Amend §2-101.11 to revise and redesignate the provision into new ¶¶ (A) and (B) to read as follows:
Responsibility
2-101.11 Assignment. *
Amend § 2-201.13 to revise the lead-in sentence to read as follows:
2-201.13 Removal, Adjustment, or Retention of Exclusions and Restrictions.
The person in charge shall adhere to the following conditions when removing, adjusting, or retaining the exclusion or restriction of a food employee:
Amend Chapter 3 to revise the word "dealer" to read "dealer" in small caps whenever the term appears.
Amend § 3-202.17 to revise subparagraph (A)(2) to read as follows:
3-202.17 Shucked Shellfish, Packaging and Identification.
Amend § 3-202.18 to revise ¶(A), subparagraphs (A)(2) and (A)(2)(a), ¶(C), and ¶(D) to read as follows:
3-202.18 Shellstock Identification.*
Amend §3-203.12 to revise ¶(A), remove existing ¶(B), add new ¶¶ (B) and (C) to read as follows:
3-203.12 Shellstock, Maintaining Identification.*
Amend § 3-403.11(D), ¶3-501.12(A), ¶¶ 3-501.13 (A) and (B), and § 3-501.14 to revise to delete all uses and cross references to Subparagraph 3-501.16 (A)(2) that referenced 7°C (45°F) cold holding to read:
3-403.11 Reheating for Hot Holding.*
3-501.12 Potentially Hazardous Food (Time/Temperature Control for Safety Food), Slacking.
Frozen potentially hazardous food (time/temperature control for safety food) that is slacked to moderate the temperature shall be held:
3-501.13 Thawing.
Except as specified in ¶ (D) of this section, potentially hazardous food (time/temperature control for safety food) shall be thawed:
3-501.14 Cooling.*
Amend §3-501.16 to revise subparagraph (A)(2)to read as follows:
3-501.16 Potentially Hazardous Food (Time/Temperature Control for Safety Food), Hot and Cold Holding.*
Amend §3-501.17 to remove existing subparagraph (A)(2) and revise existing ¶(A) and subparagraph (A)(1) to combine into new ¶(A) to read as follows:
3-501.17 Ready-to-Eat, Potentially Hazardous Food (Time/Temperature Control for Safety Food), Date Marking.*
Amend §3-501.19 to revise to read as follows:
3-501.19 Time as a Public Health Control.*
Amend §3-502.12 to revise subparagraphs (D)(2)(c), (D)(2)(d), and (D)(2)(e) to correct subparagraph (2)(c), revise subparagraph (2)(d) to specify when bags are sealed and remove subparagraph (2)(e)(i)-(ii) and replace it with a new subparagraph (2)(e)(i)-(iv) to provide for additional options to read as follows:
3-502.12 Reduced Oxygen Packaging, Criteria.*
Amend §4-203.13 to revise to read as follows:
4-203.13 Pressure Measuring Devices, Mechanical Warewashing Equipment.
Pressure measuring devices that display the pressures in the water supply line for the fresh hot water sanitizing rinse shall have increments of 7 kilopascals (1 pound per square inch) or smaller and shall be accurate to ±14 kilopascals (±2 pounds per square inch) in the range indicated on the manufacturer's data plate.
Amend §4-204.13 to add new ¶(E) and subparagraphs (E)(1) and (E)(2) to read as follows:
4-204.13 Dispensing Equipment, Protection of Equipment and Food.
In equipment that dispenses or vends liquid food or ice in unpackaged form:
Amend subparagraph 4-204.111(B)(1) to revise to delete cross reference to Subparagraph 3-501.16 (A)(2) that referenced 7°C ( 45°F) cold holding to read:
4-204.111 Vending Machines, Automatic Shutoff.*
Amend § 4-501.113 to revise to read as follows:
4-501.113 Mechanical Warewashing Equipment, Sanitizing Rinse Pressure.
The flow pressure of the fresh hot water sanitizing rinse in a warewashing machine, as measured in the water line immediately downstream or upstream from the fresh hot water SANITIZING rinse control value, shall be within the range specified on the machine manufacturer's data plate and may not be less than 35 kilopascals (5 pounds per square inch) or more than 200 kilopascals (30 pounds per square inch).
2. BIBLIOGRAPHY
1-201.10(B) Terms, Defined.
Amend references for §1-201.10(B) to add new references following the existing list of references to support the addition of cut tomatoes to the definition of potentially hazardous food (time-temperature control for safety food) and continue numbering to read as follows:
Amend references for §4-204.13 to add new reference for §4-204.13 to read as follows:
3.Supporting Documents
Amend Supporting Documents to add a new supporting document summary for the Retail Food Protection Program Information Manual entitled, "Storage and Handling of Tomatoes", 2007 to read as follows:
N. Retail Food Protection Program Information Manual: Storage and Handling of Tomatoes, 2007.
The Retail Food Protection Program Information Manual, Storage and Handling of Tomatoes provides safe storage and handling practices for cut tomatoes and additional rationale for including cut tomatoes in the definition of potentially hazardous food (time/temperature control for safety food) in the 2005 Food Code. Historically, uncooked fruits and vegetables have been considered non-PHF (non-TCS food) unless they were epidemiologically implicated in foodborne illness outbreaks and are capable of supporting the growth of pathogenic bacteria in the absence of temperature control. Since 1990, at least 12 multi-state foodborne illness outbreaks have been associated with different varieties of tomatoes. From 1998 - 2006, outbreaks associated with tomatoes made up 17% of the produce-related outbreaks reported to FDA. Salmonella has been the pathogen of concern most often associated with tomato outbreaks. Recommendations are being offered to prevent contamination in food service facilities and retail food stores and to reduce the growth of pathogenic bacteria when contamination of fresh tomatoes may have already occurred (regardless of the location where the contamination occurred).
Supporting Documents A. through M. remain the same as in the 2005 Food Code.
Applicability and Terms Defined
1-201.10 Statement of Application and Listing of Terms.
Amend Public Health Reason for §1-201.10 to add new paragraphs on Food Establishment and Food Processing Plant between the existing text for "Accredited Program" and "Egg" and revise text for Potentially Hazardous Food (Time/Temperature Control for Safety Food) following "Egg" to read as follows:
Terms Defined
(B) Terms Defined
The individual definitions in Chapter 1 are not numbered, consistent with current conventions regarding the use of plain language in drafting rules, and with use in national and international standards and some Federal regulations. This facilitates making changes to the definitions as they become necessary in subsequent editions of the Food Code. The intent of the definitions to be binding in terms of the application and interpretation of the Code is clearly stated in Chapter 1.
Accredited Program. No change
Food Establishment and a food processing plant located within the same premises of a Food Establishment
Some food businesses perform operations that provide food directly to consumers as a "Food Establishment," and also supply food to other business entities as a "Food Processing Plant." Within such a business, those operations that provide food directly to consumers only should be considered part of a "Food Establishment" for the purposes of applying the Food Code while those operations that supply food to other business entities may be subject to other rules and regulations that apply to "Food Processing Plants". It is essential that the permit holder and persons in charge be aware that regulatory requirements and the appropriate operational practices for "Food Establishments" may differ from those for "Food Processing Plants."
Some facilities and functions may be subject to different regulatory requirements depending on whether that facility or function is regulated as a "Food Establishment" or as a "Food Processing Plant", or both. Those facilities and functions within a business that are shared by both the "Food Establishment" and "Food Processing Plant" operations, e.g., refrigeration units, dressing room and toilet facilities, food equipment, water and waste systems, pest control, might be subject to similar regulatory requirements. The Food Code is intended to apply to "food establishments".
Egg. No change
Potentially Hazardous Food (Time/Temperature Control for Safety Food)
Potentially hazardous food (PHF/TCS food) is defined in terms of whether or not it requires time/temperature control for safety to limit pathogen growth or toxin formation. The term does not include foods that do not support growth but may contain a pathogenic microorganism or chemical or physical food safety hazard at a level sufficient to cause foodborne illness or injury. The progressive growth of all foodborne pathogens is considered whether slow or rapid.
The definition of PHF/TCS food takes into consideration pH, aw, pH and aw interaction, heat treatment, and packaging for a relatively simple determination of whether the food requires time/temperature control for safety. If the food is heat-treated to eliminate vegetative cells, it needs to be addressed differently than a raw product with no, or inadequate, heat treatment. In addition, if the food is packaged after heat treatment to destroy vegetative cells and subsequently packaged to prevent re-contamination, higher ranges of pH and/or aw can be tolerated because remaining spore-forming bacteria are the only microbial hazards of concern. While foods will need to be cooled slightly to prevent condensation inside the package, they must be protected from contamination in an area with limited access and packaged before temperatures drop below 57°C (135°F). In some foods, it is possible that neither the pH value nor the aw value is low enough by itself to control or eliminate pathogen growth; however, the interaction of pH and aw may be able to accomplish it. This is an example of a hurdle technology. Hurdle technology involves several inhibitory factors being used together to control or eliminate pathogen growth, when they would otherwise be ineffective if used alone.
In determining if time/temperature control is required, combination products present their own challenge. A combination product is one in which there are two or more distinct food components and an interface between the two components may have a different property than either of the individual components. A determination must be made about whether the food has distinct components such as pie with meringue topping, focaccia bread, meat salads, or fettuccine alfredo with chicken or whether it has a uniform consistency such as gravies, puddings, or sauces. In these products, the pH at the interface is important in determining if the item is a PHF/TCS food.
A well designed inoculation study or other published scientific research should be used to determine whether a food can be held without time/temperature control when:
Before using Tables A and B in paragraph 1-201.10(B) of the definition for "potentially hazardous food (time/temperature control for safety food)" in determining whether a food requires time/temperature control for safety (TCS), answers to the following questions should be considered:
A food designated as product assessment required (PA), in either table should be considered PHF/TCS Food until further study proves otherwise. The PA means that based on the food's pH and aw and whether it was raw or heat-treated or packaged, it has to be considered PHF until inoculation studies or some other acceptable evidence shows that the food is a PHF/TCS food or not. The Food Code requires a variance request to the regulatory authority with the evidence that the food does not require time/temperature control for safety.
The Food Code definition designates certain raw plant foods as PHF/TCS food because they have been shown to support the growth of foodborne pathogens in the absence of temperature control and to lack intrinsic factors that would inhibit pathogen growth. Unless product assessment shows otherwise, these designations are supported by Tables A and B. For example:
For cut cantaloupe (pH 6.2-7.1, aw > 0.99, not heat-treated), fresh sprouts (pH > 6.5, aw > 0.99, not heat-treated), and cut tomatoes (pH 4.23 - 5.04, aw > 0.99, not heat-treated), Table B indicates that they are considered PHF/TCS foods unless a product assessment shows otherwise. Maintaining these products under the temperature control requirements prescribed in this code for PHF/TCS food will limit the growth of pathogens that may be present in or on the food and may help prevent foodborne illness.
If a facility adjusts the pH of a food using vinegar, lemon juice, or citric acid for purposes other than flavor enhancement, a variance is required under ¶ 3-502.11(C). A HACCP plan is required whether the food is a PHF/TCS food as in subparagraph 3-502.11(C)(1) or not a PHF/TCS food, as in subparagraph 3-502.11(C)(2). A standardized recipe validated by lab testing for pH and aw would be an appropriate part of the variance request with annual (or other frequency as specified by the regulatory authority) samples tested to verify compliance with the conditions of the variance.
More information can be found in the Institute of Food Technologists (IFT) Report, Evaluation and Definition of Potentially Hazardous Foods.
Continue with current language in the Code (Instructions for using Decision Tree and Tables A and B
Responsibility
2-101.11 Assignment.*
Amend Public Health Reasons for § 2-101.11 to revise to read as follows:
Designation of a person in charge during all hours of operations ensures the continuous presence of someone who is responsible for monitoring and managing all food establishment operations and who is authorized to take actions to ensure that the Code's objectives are fulfilled. During the day-to-day operation of a food establishment, a person who is immediately available and knowledgeable in both operational and Code requirements is needed to respond to questions and concerns and to resolve problems.
In cases where a food establishment has several departments on the premises (e.g., a grocery store with deli, seafood, and produce departments) and the regulatory authority has permitted those departments individually as separate food establishments, it may be unnecessary from a food safety standpoint to staff each department with a separate Person in Charge during periods when food is not being prepared, packaged or served. While activities such as moving food products from a refrigerated display case to the walk-in refrigerator, cleaning the floors, or doing inventory when the department is not busy, do take place during these times, a designated Person in Charge for multiple departments or the entire facility can oversee these operations and be ready to take corrective actions if necessary.
2-201 Infected Food Employees and Conditional Employees
Practical Applications of Using Subpart 2-201
Amend Public Health Reasons for Part 2-201 to revise to read as follows:
The information provided in Subpart 2-201 is designed to assist food establishment managers and regulatory officials in removing infected food employees when they are at greatest risk of transmitting foodborne pathogens to food. Practical applications of the information in Subpart 2-201 by a food establishment manager may involve using Subpart 2-201 as a basis for obtaining information on the health status of food employees and can also be used as a basis in developing and implementing an effective Employee Health Policy. Regulatory officials can benefit by using the information provided below as a basis for determining compliance with Subpart 2-201 during a facility food safety inspection.
The development and effective implementation of an employee health policy based on the provisions in Subpart 2-201 may help to prevent foodborne illness associated with contamination of food by ill or infected food employees. The person in charge and food employees should be familiar with and able to provide the following information through direct dialogue or other means when interviewed by facility managers or regulatory officials. Compliance must be based, however, on first hand observations or information and cannot be based solely on responses from the person in charge to questions regarding hypothetical situations or knowledge of the Food Code. Also, when designing and implementing an employee health policy, the following information should be considered and addressed:
Amend Public Health Reasons for § 2-201.12 Table 1b, Summary of Requirements for Diagnosed Symptomatic Food Employees to revise the use of the word "may" to "shall" under "Removing diagnosed symptomatic food employees from exclusion" for E. coli O157:H7, Norovirus, and Shigella spp., to read as follows:
| Food employees and conditional employees shall report a listed Diagnosis with symptoms immediately to the person in charge | |||
|
The person in charge shall notify the RA when a food employee is jaundiced or reports a listed diagnosis | |||
| The person in charge shall prohibit a conditional employee that reports a listed diagnosis with symptoms from becoming a food employee until meeting the criteria listed in section 2-201.13 of the Food Code, for reinstatement of a diagnosed, symptomatic food employee. | |||
| Diagnosis | EXCLUSION Facilities Serving HSP or not Serving HSP |
Removing diagnosed, symptomatic food employees from exclusion | RA Approval Needed to Return to Work? |
|---|---|---|---|
| Hepatitis A virus | EXCLUDE if within 14 days of any symptom, or within 7 days of jaundice2-201.12(B)(2) |
When approval is obtained from the RA 2-201.13(B), and:
|
Yes |
| Typhoid Fever (S. Typhi) | EXCLUDE 2-201.12(C) |
When approval is obtained from the RA 2-201.13(C)(1), and:
|
Yes |
| E. coli O157:H7 or other EHEC/ STEC | EXCLUDE Based on vomiting or diarrhea symptoms, under 2-201.12(A)(2) |
|
Yes to return to HSP or to return unrestricted; Not required to work on a restricted basis in a non-HSP facility |
| Norovirus |
EXCLUDE Based on vomiting or diarrhea symptoms, under 2-201.12(A)(2) |
|
Yes to return to HSP or to return unrestricted; Not required to work on a restricted basis in a non-HSP facility |
| Shigella spp. | EXCLUDE Based on vomiting or diarrhea symptoms, under 2-201.12(A)(2) |
|
Yes to return to HSP or to return unrestricted; Not required to work on a restricted basis in a non-HSP facility |
Amend Public Health Reasons for § 2-201.12 Table 2, Summary of Requirements for Diagnosed Food Employees with Resolved Symptoms, to revise the use of the word "may" to "shall" under "Removing Diagnosed Food Employees with Resolved Symptoms from Exclusion or Restriction" for E.coli O157:H7, Norovirus, and Shigella spp., to read as follows:
|
Food employees and conditional employees shall report a Listed diagnosis immediately to the person in charge |
||||
|
The person in charge shall notify the RA when a food employee reports a listed diagnosis | ||||
| The person in charge shall prohibit a conditional employee that reports a listed diagnosis from becoming a food employee until meeting the criteria listed in section 2-201.13 of the Food Code, for reinstatement of a diagnosed food employee. | ||||
| Pathogen Diagnosis | Facilities Serving HSP | Facilities Not Serving HSP | Removing Diagnosed Food Employees with Resolved Symptoms from Exclusion or Restriction | RA Approval Required to Return to Work |
|---|---|---|---|---|
| Typhoid fever (S. Typhi) including previous illness with S. Typhi (see 2-201.11(A)(3) | EXCLUDE 2-201.12(C) |
EXCLUDE 2-201.12(C) |
When approval is obtained from the RA 2-201.13(C)(1), and:
|
Yes |
| Shigella spp. | EXCLUDE 2-201.12(E)(1) |
RESTRICT 2-201.12(E)(2) |
|
Yes to return to HSP or to return unrestricted; Not required to work on a restricted basis in a non-HSP facility |
| Norovirus | EXCLUDE 2-201.12(D)(1) |
RESTRICT 2-201.12(D)(2) |
|
Yes to return to HSP or to return unrestricted; Not required to work on a restricted basis in a non-HSP facility |
| E. coli O157:H7 or other EHEC/ STEC | EXCLUDE 2-201.12(F)(1) |
RESTRICT 2-201.12(F)(2) |
|
Yes to return to HSP or to return unrestricted; Not required to work on a restricted basis in a non-HSP facility |
| Hepatitis A virus | EXCLUDE if within 14 days of any symptom, or within 7 days of jaundice2-201.12(B)(2) | EXCLUDE if within 14 days of any symptom, or within 7 days of jaundice2-201.12(B)(2) | When approval is obtained from the RA 2-201.13(B), and:
|
Yes |
Amend Public Health Reasons for § 2-201.13 to revise to read as follows:
2-201.13 Removal of Exclusions and Restrictions.1
Food employees diagnosed with Norovirus, hepatitis A virus, Shigella spp., E. coli O157:H7 or other EHEC, and symptomatic with diarrhea, vomiting, or jaundice, are excluded under subparagraph 2-201.12 (A)(2) or 2-201.12(B)(2). However these symptomatic, diagnosed food employees differ from symptomatic, undiagnosed food employees in the requirements that must be met before returning to work in a full capacity after symptoms resolve.
The person in charge may allow undiagnosed food employees who are initially symptomatic and whose symptoms have resolved to return to work in a full capacity 24 hours after symptoms resolve.
However, diagnosis with a listed pathogen invokes additional requirements before the person in charge may allow diagnosed food employees to return to work in full capacity.
Asymptomatic food employees diagnosed with Norovirus, Shigella spp., E. coli O157:H7 or other EHEC may not return to work in a full capacity for at least 24 hours after symptoms resolve. The person in charge shall only allow these food employees to work on a restricted basis 24 hours after symptoms resolve and they shall only allow this if not in a food establishment that serves a highly susceptible population. These restricted food employees remain restricted until they are medically cleared or otherwise meet the criteria for removal from restriction as specified under subparagraphs 2-201.13(D) (1)-(2); 2-201.13(E)(1)-(2); or 2-201.13(F)(1)-(2).
In a food establishment that serves a highly susceptible population, food employees who are diagnosed with Norovirus, Shigella spp., E. coli O157:H7 or other EHEC and initially symptomatic with vomiting or diarrhea, shall not work on a restricted basis after being asymptomatic for at least 24 hours. These food employees must remain excluded until they are medically cleared or otherwise meet the criteria for removal from exclusion from a highly susceptible population under subparagraph 2-201.13(D) (1)-(2), 2-201.13(E)(1)-(2), or 2-201.13 (F)(1)-(2).
Food employees diagnosed with hepatitis A virus are always excluded if diagnosed within 14 days of exhibiting any illness symptom, until at least 7 days after the onset of jaundice, or until medically cleared as specified under subparagraphs 2-201.13(B)(1) -(4).
Food employees diagnosed with hepatitis A virus are always excluded if diagnosed within 14 days of exhibiting any illness symptom, until at least 7 days after the onset of jaundice, or until medically cleared as specified under subparagraph 2-201.13(B)(1)-(3). A food employee with an anicteric infection with the hepatitis A virus has a mild form of hepatitis A without jaundice. Food employees diagnosed with an anicteric infection with the hepatitis A virus are excluded if they are within 14 days of any symptoms. Anicteric, diagnosed food employees shall be removed from exclusion if more than 14 days have passed since they became symptomatic, or if medically cleared. Asymptomatic food employees diagnosed with an active infection with the hepatitis A virus are also excluded until medically cleared.
[Continue on with text of 2-201.13 PHR as in 2005 Food Code with no changes]
Amend Public Health Reasons for § 3-203.12 to add three new paragraphs to the end of the introductory text to read as follows:
3-203.12 Shellstock, Maintaining Identification.*
Accurate records that are maintained in a manner that allows them to be readily matched to each lot of shellstock provide the principal mechanism for tracing shellstock to its original source. If an outbreak occurs, regulatory authorities must move quickly to close affected growing areas or take other appropriate actions to prevent further illnesses. Records must be kept for 90 days to allow time for hepatitis A virus infections, which have an incubation period that is significantly longer than other shellfish-borne diseases, to come to light. The 90-day requirement is based on the following considerations:
In reality and as stated in the provision, the 90-day "clock" starts at the time the container of shellstock is emptied. Starting from the date of harvest is not correct because the shellstock may be sold/consumed in less than the 14 days of shelf life cited in the chart above. Therefore, the 90 days may expire and the tag discarded before an illness is reported and investigated.
Shellstock could be frozen in the food establishment during the 14-day estimated shelf life period, which would effectively stop the clock on the shelf life. The shellstock could be thawed and consumed past the 14-day shelf life. In this case, the 90 days would expire before consumption if the clock started 90 days from the harvest date.
Freezing shellstock in the food establishment is not usually done because, although oysters-in-the-shell can be frozen with fair results, they do not have the same texture and appearance of a fresh oyster when thawed. Commercially frozen oysters are frozen rapidly to retain product quality.
Amend Public Health Reasons for §3-401.13 to revise the hot holding temperature to read as follows:
3-401.13 Plant Food Cooking for Hot Holding.*
Fruits and vegetables that are fresh, frozen, or canned and that are heated for hot holding need only to be cooked to the temperature required for hot holding. These foods do not require the same level of microorganism destruction as do raw animal foods since these fruits and vegetables are ready-to-eat at any temperature. Cooking to the hot holding temperature of 57°C (135°F) prevents the growth of pathogenic bacteria that may be present in or on these foods. In fact, the level of bacteria will be reduced over time at the specified hot holding temperature.
Amend the Public Health Reasons for §3-501.16 to add three new paragraphs under "COLD HOLDING" and to add new information on the historical record of the cold holding temperature provisions to the end of the existing text to read as follows:
3-501.16 Potentially Hazardous Food (Time/Temperature Control for Safety Food), Hot and Cold Holding.*
Bacterial growth and/or toxin production can occur if potentially hazardous food (time/temperature control for safety food) remains in the temperature "Danger Zone" of 5°C to 57°C (41°F to 135°F) too long. Up to a point, the rate of growth increases with an increase in temperature within this zone. Beyond the upper limit of the optimal temperature range for a particular organism, the rate of growth decreases. Operations requiring heating or cooling of food should be performed as rapidly as possible to avoid the possibility of bacterial growth.
Cold Holding
Maintaining PHF (TCS) foods under the cold temperature control requirements prescribed in this code will limit the growth of pathogens that may be present in or on the food and may help prevent foodborne illness. All microorganisms have a defined temperature range in which they grow, with a minimum, maximum, and optimum. An understanding of the interplay between time, temperature, and other intrinsic and extrinsic factors is crucial to selecting the proper storage conditions for a food product. Temperature has dramatic impact on both the generation time of an organism and its lag period.
When considering growth rate of microbial pathogens, time and temperature are integral and must be considered together. Increases in storage and/or display temperature will decrease the shelf life of refrigerated foods since the higher the temperature, the more permissive conditions are for growth.
The exception for holding potentially hazardous food (time/temperature control for safety food in specially designed dispensing equipment recognizes technology designs that maintain the safety of aseptically-packaged fluid foods when the equipment is manufactured and operated in conformance with the NSF/ANSI Standard No. 18. NSF/ANSI 18 was revised in 2006, with FDA input, to address the storage of certain types of potentially hazardous food or beverages in dispensing equipment without temperature control. The key condition for FDA allowing this exemption from 3-501.16 is that the equipment conforms to the requirements as specified in NSF/ANSI 18.
Except for raw shell eggs, control of the growth of Listeria monocytogenes (Lm) is the basis for the list of cold holding temperature and time combinations in paragraph 3 501.17(A). The list addresses time, in addition to temperature, as a control for the growth of Lm in refrigerated, ready-to-eat, potentially hazardous food (time/temperature control for safety food). The Code provisions for cold holding focus on environmental conditions that allow 1 log of growth of Lm, and do not set an acceptable number of Lm in food. Neither do they imply that Lm is in the product.
The times and temperatures in the 1999 Food Code were based on the USDA Pathogen Modeling Program (PMP), which is conservative in estimating how soon Lm begins to grow and how fast. The PMP was based largely on observations of microbial growth in broth cultures, but some observations in specific foods were also included. The PMP allows for some variation in temperature, pH, and water activity, and gives a conservative estimate of safe times and temperatures for holding foods. The 1999 Food Code estimated safe times and temperatures that would allow 3 logs of growth, based on the PMP.
During 2000, CFSAN researched published literature and compiled a listing of the growth potential of Lm in various food commodities using real food data. Based on this information, the 1999 Food Code times and temperatures of 41°F for 7 days and 45°F for 4 days were validated, but the underlying performance standard changed for the commodities studied. The research-based, food-specific times and temperatures allow no more than 1 log of growth instead of the 3 log growth predicted in the PMP. This more stringent performance standard of 1 log is consistent with the USDA/FSIS performance standard and the fact that the infectious dose of Lm remains unknown.
FDA concluded that the 1999 Code time/temperature criteria hold true and provide both a greater level of safety and a more realistic basis for regulatory requirements without compromising public health protection.
In September 2003, FDA, in cooperation with the USDA/FSIS and CDC, released the Quantitative Assessment of the Relative Risk to Public Health from Foodborne Listeria monocytogenes Among Selected Categories of Ready-to-Eat Foods (risk assessment). This initiative included the development of 23 separate risk assessments and analysis of the relative risks of serious illness and death associated with consumption of 23 categories of ready-to-eat foods. These categories included: seafood, produce, meats, dairy products, and deli salads.
The risk assessment identified several broad factors that affect consumer exposure to Lm at the time of food consumption. Two of these factors, refrigerated storage temperature and duration of refrigerated storage before consumption, have a direct bearing on cold holding time/temperature combinations used in food establishments.
FDA continues to have concerns about the potential for growth of Lm in refrigerated, ready-to-eat, potentially hazardous food (time/temperature control for safety food), prepared and packaged in a food processing plant and held in a food establishment. Data from the risk assessment (see the following Annex 3 3-501.16 Table 1) show a significant reduction in the projected cases of listeriosis when refrigerated storage is limited to 41°F. Based on these data and conclusions from the risk assessment, FDA continues to recommend that food establishments limit the cold storage of potentially hazardous (time/temperature control for safety), ready-to-eat foods to a maximum temperature of 41°F.
| Maximum Refrigerator Temperature | Cases of Listeriosisa | ||
|---|---|---|---|
| Median | 55th Percentile | 95th Percentile | |
| Baselineb | 2105 | 3/4c | 3/4c |
| 7°C (45°F) maximum | 656 | 331 | 761 |
| 5°C (41°F) maximum | 28 | 1 | 126 |
aValues for the median, upper and lower uncertainty levels.
bThe baseline uses the full empirical distribution of refrigerator temperatures from the Audits International (1999) survey.
cThe baseline number of cases of listeriosis is fixed based on CDC surveillance data.
*The scenario assumed the distribution of storage times is the same for all three temperature sets.
Source: Quantitative Assessment of the Relative Risk to Public Health from Foodborne Listeria monocytogenes Among Selected Categories of Ready-to-Eat Foods September 2003. Table VI-1. Estimated Reduction of Cases of Listeriosis from Limits on Refrigeration Temperatures.
Regarding shell eggs, USDA published a final rule (63 FR 45663, August 27, 1998 Refrigeration and Labeling Requirements for Shell Eggs) to require that shell eggs packed for consumer use be stored and transported at an ambient temperature not to exceed 7°C (45°F). This regulation, however, does not apply to eggs while held at all retail establishments. FDA is concerned that without continued refrigeration up until the time that the eggs are cooked, there would be an opportunity for the egg's defenses to degrade and growth of Salmonella Enteritidis to occur. The agency reviewed research indicating that Salmonella Enteritidis multiplies at temperatures of 10°C (50°F) and above but can be inhibited at lower temperatures, e.g., 8°C (46°F), 7°C (45°F), and 4°C (39°F). Based on this research and USDA's temperature requirement during transport, FDA implemented regulations that establish a maximum ambient air temperature of 7°C (45°F) for eggs stored and displayed at retail establishments. Amended Federal regulations 21 CFR Part 115.50 issued on December 5, 2000 and became effective on June 4, 2001.
Although Congress did not expressly preempt State law in this area, FDA found preemption is needed because State and local laws that are less stringent than the Federal requirements will not support the important public health goals of these regulations. FDA does not believe that preemption of State and local refrigeration and labeling requirements that are the same as or more stringent than the requirements of these regulations is necessary, as enforcement of such State and local requirements will support the food safety goals of these regulations. Accordingly, the preemptive effect of this rule is limited to State or local requirements that are not as stringent as the requirements of these regulations; requirements that are the same as or more stringent than FDA's requirements remain in effect.
Historical Record of Cold Holding Temperature Provisions
The 1976 Food Service Sanitation Manual recommended 45°F as the cold holding temperature. Based on the available science at the time, the 1993 Food Code lowered the cold holding temperature to 41°F.
However, stakeholders raised concerns that many of the refrigerators currently in place in food establishments would not be capable of maintaining food at that temperature. There was also concern that most of the open-top buffet and food prep table-type units being built at the time could not reliably maintain food at 41°F or less. Industry pointed out that operators needed to recover investments in new refrigeration equipment purchased just before or after a state adopted the 41°F provision.
Consequently, the Conference of Food Protection (CFP) recommended the 1997 Food Code incorporate the option of having a 5-year phase-in period for the 41°F requirement to allow for upgrading of existing equipment, and the FDA agreed.
By 2006, many states adopted and implemented the phase-in period, the 5 years had expired and they were requiring cold holding at 41°F or less. In addition, NSF/ANSI Standard 7 was revised in 1997 and again in 1999 to ensure that equipment conforming to the Standard, including open-top and display units, could achieve the desired performance under conditions typically found in the food service and retail environments. Thus, there are mechanisms in place to allow industry flexibility in holding foods out of temperature control and the exemption for holding at 45°F was no longer necessary, given equipment capabilities, existing provisions of the Food Code that could be utilized (e.g., variances, time as a public health control), and the impact on public health. Additionally, the FDA believed this exemption was no longer necessary and perhaps was detrimental to public health protection in light of what had been learned about the growth and survival of Listeria monocytogenes (LM) in refrigerated foods.
In 2006, the CFP recommended (CFP Issue 2006-I-033) and FDA agreed that the option of maintaining 45°F as a cold holding temperature be deleted from § 3-501.16. In the Supplement to the 2005 Food Code, the option to maintain 45°F as the cold holding temperature was deleted from the Food Code and 41°F became the standard for cold holding.
Amend the Public Health Reasons for §3-501.19 to revise to add a rationale for the change to the codified provision to read as follows:
3-501.19 Using Time as a Public Health Control.*
The 2000 Conference for Food Protection (CFP) meeting recommended that FDA ask the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) to review the Food Code provision that addresses using time alone as a public health control, section 3-501.19. In response to the CFP recommendation, FDA in consultation with USDA/FSIS, determined that there is sufficient scientific information available to support the current provision in the Food Code without requesting consideration by the NACMCF. As an alternative response, FDA informed the CFP that it would provide the following position paper on using time alone as a public health control.
Position Paper
Food Code section 3-501.19 allows potentially hazardous food (time/temperature control for safety) food that is ready-to-eat (RTE) to be stored without temperature control for up to 4 hours, after which it must be discarded or consumed or for up to 6 hours for refrigerated food, if the food is 5°C (41°F) when initially removed from temperature control, and as long as the food temperature does not exceed 21°C (70°F). The following information is provided to explain the reasoning in allowing time alone to be used as a public health control for food safety.
Background information
Food kept without temperature control allows product to warm or cool as it equilibrates with the environment. Each temperature scenario incurs different risks in regard to the type of foodborne pathogens able to grow and the rate of growth likely to occur. For both cooling and warming conditions, growth depends on the amount of time the food spends in an optimum growth temperature range during its equilibration with its surroundings. Several factors influence the rate of temperature change in a food, such as the type of food, thickness of the food, and temperature differential between the food and its surroundings. When evaluating the safety of a 4-hour limit for food with no temperature control, products and environmental parameters must be selected to create a worst-case scenario for pathogens growth and possible toxin production.
Holding Cold Food Without Temperature Control
When a food is removed from refrigerated storage and begins to warm to room temperature, Listeria monocytogenes is a primary organism of concern. Even while food is held at refrigeration temperatures, the growth potential of L. monocytogenes warrants concern for potentially hazardous (time/temperature control for safety foods) RTE foods. Although the FDA and USDA have a zero tolerance for L. monocytogenes in RTE food, conditions are permitted in the Food Code that would allow L. monocytogenes cells 1 log of growth (3.3 generations). Salmonella is also a concern especially with products containing eggs. However L. monocytogenesgrows more rapidly than Salmonella at refrigeration and room temperatures. By ensuring minimal Listeria growth in food, the threat from Salmonella would be negligible. Warming conditions will allow food to remain exposed to temperatures that allow B. cereus to produce emetic toxin. However the 4-hour time constraint in the Food Code is sufficient to prevent any toxin formation.
For food refrigerated at 41°F or 45°F then transferred to an ambient temperature of 75°F for 4 hours, the growth rate of L. monocytogenes remains slow enough to ensure that the critical limit of 1 log growth is not reached. Published generation times at 75°F for L. monocytogenes in food were not found, however published values at 68°F and 70°F in egg and milk products confirmed slow L. monocytogenes growth at room temperatures.
Using the USDA Pathogen Modeling Program (PMP) and assuming the optimum conditions of pH 6.8, 0.5% NaCl, 0.0% nitrite, L. monocytogenes would require more than 4 hours to grow 1 log at 75°F. The PMP is based on broth studies and not on food products. Therefore, the growth rates reported at various temperatures by the PMP are faster than growth rates in most food products. Another factor exaggerating the growth rate in this warming scenario as predicted by the PMP is the assumption that the food product spent all 4 hours at 75°F. Obviously food equilibrates with the surrounding environment at a gradual rate and would not equilibrate instantly.
Unfortunately there are no models that take changing temperatures into consideration when predicting growth. Likewise there are very few published papers dealing with the growth of organisms in food during warming. The conservative nature of the 4-hour limit for keeping foods without temperature control allows for a needed margin of safety if the temperature of the environment is higher than 75°F.
It is important to note that potentially hazardous (time/temperature control for safety) foods held without cold holding temperature control for a period of 4 hours do not have any temperature control or monitoring. These foods can reach any temperature when held at ambient air temperatures as long as they are discarded or consumed within the four hours.
Holding Hot Food without Temperature Control
The second scenario for food without temperature control exists when food is cooked according to Food Code recommendations, then kept at room temperature for 4 hours before discarding. Foodborne pathogens of concern for an uncontrolled temperature scenario are sporeformers including Clostridium perfringens and Bacillus cereus. Food cooked according to Food Code guidelines should be free of vegetative cells. However, the heat requirements are not sufficient to kill spores of C. perfringens or B. cereus and may actually serve as a heat shock that activates the spores. B. cereus is found commonly in outbreaks attributed to inadequate hot holding of starchy foods like rice, and has been isolated in a multitude of food products. C. perfringens is found commonly in outbreaks attributed to inadequate hot holding of beef and poultry. Despite the prevalence of both spores in nature, C. perfringens cases are estimated to be more numerous than B. cereus cases by a factor of 10.
B. cereus can produce emetic toxin in food, and the optimum temperature for the production of toxin is between 77°F and 86°F. However, the time needed to produce the toxin is longer than the time the food will be exposed to any temperature range with a 4-hour holding limit. Both C. perfringens and B. cereus produce enterotoxin inside the intestine of the infected host if substantial numbers of vegetative cells are present in the food (105-7 CFU/g). Although the reported levels of both spores in raw foods vary in the literature, generally the level expected in food can be assumed to be low (around 10-1000 CFU/g). This implies that conditions allowing 1 log growth of either spore could be tolerated in food.
During the time without temperature control, the temperature of the food could decrease slowly enough to expose spores of both organisms to optimal growth conditions for a significant length of time. Like warming, several variables exist that determine the rate of heat transfer. Because of the wide variety of foods prepared it would be impossible to generalize how fast a typical product loses temperature after cooking. As with warming, it is prudent to imagine a worst-case scenario where heat loss is slowed. A beef roast slow cooked to 130°F for the appropriate time according to the Food Code was used as consideration for possible spore growth. Cooking roast beef to 130°F can create an anaerobic environment in both the meat and gravy. The low internal temperature creates a small temperature differential with the environment (assumed at 75°F), allowing for a slower decrease in the food's temperature.
After evaluating published studies as well as data collected at the FDA, the surface of a roast beef or rolled meat product would lose heat quickly enough to discourage significant growth of either C. perfringens or B. cereus. If all spores were distributed on the surface of the product by either pre- or post-cooking contamination, storing this product for 4 hours at room conditions would be considered safe. Likewise, products that are stirred or products that lose heat faster than a roast would also be considered safe.
End of position paper
At the 2004 meeting of the CFP, a committee submitted and the Conference accepted a document that examined scientific research related to the growth of Listeria monocytogenes, and the influence of time and temperature on its growth. The CFP committee report is found at http://www.foodprotect.org/doc/04_issues/FOLDER_ATTACHMENTS/III-008a%20finalreport-timeasapublichealthcontrol.pdf.
The 2004 CFP report stated that the USDA-PMP program can be used as a tool to estimate time periods for a 1-log increase in growth for Listeria monocytogenes in ideal (laboratory media) growth conditions. Using this modeling approach, at 41°F, 45°F, and 50°F, the time for a 1-log increase was, 87.8, 53.9, and 34.7 hours, respectively. At room temperature (70°F) a 1-log increase was noted at 5.2 hours and at ideal growth temperatures (95°F), the reported time for a 1-log increase was 3.0 hours. In general, the data from the USDA-PMP program provides very conservative growth data and, in most cases, growth would be expected to be less rapid in a food system. This table does provide comparative information relative to growth rates at different holding temperatures in the event that time was used as a factor in managing food safely.
The report further recommended that food could safely be held for up to 6 hours without external temperature control as long as the food temperature did not exceed 70°F. Based on that report and data from the Quantitative Assessment of the Relative Risk to Public Health from Foodborne Listeria monocytogenes Among Selected Categories of Ready-to-Eat Foods September 2003, the Food Code allows potentially hazardous food (time/temperature control for safety) food to be stored up to 6 hours without external temperature control provided that the food temperature does not exceed 70°F and the food is discarded or consumed at the end of the 6 hours.
The Safety of the Time as a Public Health Control Provision from Cooking Temperatures (135°F or above) to Ambient
FDA conducted in-house laboratory experiments to test the safety of the existing TPHC provisions of 4 hours without temperature control starting with an initial temperature of 135°F or above. Clostridium perfringens was chosen to represent a worst case scenario pathogen for foods allowed to cool from cooking temperatures to ambient without temperature control because its spores can survive normal cooking procedures, it can grow at relatively high temperatures (>120°F) and it has a short lag period. C. perfringens spores were inoculated into foods that were cooked and then cooled to yield a cooling curve that would promote outgrowth as quickly as possible. The growth data suggest that the existing 4-hour TPHC provision will be safe for 6 hours after cooking, with the additional 2-hour margin of safety built-in for consumer handling.
Consumer Handling Practices
An Audits International study was funded in 1999 by FDA to determine the food handling practices of consumers purchasing food at retail and returning home to refrigerate their items. Forty-six (46) states are represented, and the data comprises several food groups purchased from different grocery-store types. The food groups represented were: pre-packaged lunch meat, deli-counter products, seafood, fresh meat, pre-packaged deli product, liquid dairy, semi-solid dairy product, ice cream, frozen entrées, frozen novelties and whipped topping.
The study evaluated information regarding time and food temperature at retail food stores, time to reach home refrigeration, temperature after transport home, location and type of retail establishment where purchase was made and type of product purchased.
For product temperature at retail and after transportation, 5 product categories were used: pre packaged lunch meat, pre packaged deli product, deli counter products, seafood and fresh meat. These categories were considered most applicable to the TPHC recommendations. The temperature ranges for these products at retail and after transport to the home are summarized in Figures 1 and 2 respectively. The data suggest that with current retail refrigeration practices, 25% of items are held above 45°F (Figure 1). The data also show that by the time the product arrives at the home, 98% of products were at 65°F or less (Figure 2).
The time of transport for all food categories from the retail establishment to home refrigeration was also recorded. The data summarized in Figure 3 shows that over 97% of the foods purchased were ready to be placed in refrigeration within 2 hours of purchase. For this histogram, all food categories except for frozen entrées were included. Because all foods end up bagged and transported together, the time each product was transported to the home was considered a valid data point and therefore used. Based on the data, a benchmark was established that PHF/TCS foods purchased in a food establishment would be either consumed, or placed under temperature control, within 2 hours.
Figure 1. Tempe