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U.S. Department of Health and Human Services

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Supplement to the 2005 Food Code

Return to Food Code 2005

front cover of FDA 2005 Food Code

Food Code 2005

U. S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
College Park, MD 20740

 

Supplement to the 2005 FDA Food Code
October 5, 2007

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)



 

INTRODUCTION

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.

 

Part 1. Summary of Changes

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

  1. 1-201.10(B)
  2. Bibliography
    Added references to support the addition of cut tomatoes to the definition of potentially hazardous food (time-temperature control for safety food) and to add new reference for §4-204.13
  3. Supporting Documents
    Added a new supporting document summary under "N." to summarize the Program Information Manual entitled, "Retail Food Protection: Storage and Handling of Tomatoes", 2007

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)

  • Item #2 -- Added reference to §2-102.20, ¶2-103.11(M), and changed reference for §2-201.11 to ¶¶2-201.11(A), (B), (C), and (E);
  • Item #3 -- Added reference to ¶¶2-201.11(D) and (F)
  • Item #45 - Updated the reference to §4-101.19 to correctly reference §4-101.17; Deleted reference to §4-101.17 and §4-101.18, since they are now included in §4-101.13; Changed reference wording for section 4-204.122 to make it consistent with the tag line to section 4-204.122 in the 2005 Food Code

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

 

Part 2.  Amendments, Additions, Deletions, to Chapters 1-8 and the Annexes


 

Amendments, Additions, Deletions to Chapter 1 Purpose and Definitions

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.

  1. (1) "Food establishment" means an operation that:
    1. (a) stores, prepares, packages, serves, vends food directly to the consumer, or otherwise provides food for human consumption such as a restaurant; satellite or catered feeding location; catering operation if the operation provides food directly to a consumer or to a conveyance used to transport people; market; vending location; conveyance used to transport people; institution; or food bank; and
    2. (b) relinquishes possession of food to a consumer directly, or indirectly through a delivery service such as home delivery of grocery orders or restaurant takeout orders, or delivery service that is provided by common carriers.
  2. (2) "Food establishment" includes:
    1. (a) An element of the operation such as a transportation vehicle or a central preparation facility that supplies a vending location or satellite feeding location unless the vending or feeding location is permitted by the regulatory authority; and
    2. (b) An operation that is conducted in a mobile, stationary, temporary, or permanent facility or location; where consumption is on or off the premises; and regardless of whether there is a charge for the food.
  3. (3) "Food establishment" does not include:
    1. (a)  An establishment that offers only prepackaged foods that are not potentially hazardous (time/temperature control for safety) foods;
    2. (b)  A produce stand that only offers whole, uncut fresh fruits and vegetables;
    3. (c) A food processing plant; including those that are located on the PREMISES of a FOOD ESTABLISHMENT
    4. (d)  A kitchen in a private home if only food that is not potentially hazardous (time/temperature control for safety) food, is prepared for sale or service at a function such as a religious or charitable organization's bake sale if allowed by law and if the consumer is informed by a clearly visible placard at the sales or service location that the food is prepared in a kitchen that is not subject to regulation and inspection by the regulatory authority;
    5. (e)  An area where food that is prepared as specified in Subparagraph (3)(d) of this definition is sold or offered for human consumption;
    6. (f)  A kitchen in a private home, such as a small family day-care provider; or a bed-and-breakfast operation that prepares and offers food to guests if the home is owner occupied, the number of available guest bedrooms does not exceed 6, breakfast is the only meal offered, the number of guests served does not exceed 18, and the consumer is informed by statements contained in published advertisements, mailed brochures, and placards posted at the registration area that the food is prepared in a kitchen that is not regulated and inspected by the regulatory authority; or
    7. (g)  A private home that receives catered or home-delivered food.

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).

  1. (1) "Potentially hazardous food (time/temperature control for safety food)" means a food that requires time/temperature control for safety (TCS) to limit pathogenic microorganism growth or toxin formation.
  2. (2) "Potentially hazardous food (time/temperature control for safety food)" includes:
    1. (a) An animal food that is raw or heat-treated; a plant food that is heat- treated or consists of raw seed sprouts, cut melons, cut tomatoes or mixtures of cut tomatoes that are not modified in a way so that they are unable to support pathogenic microorganism growth or toxin formation, or garlic-in-oil mixtures that are not modified in a way so that they are unable to support pathogenic microorganism growth or toxin formation; and
    2. (b) no change

 

Amendments, Additions, Deletions to Chapter 2 Management and Personnel

Amend §2-101.11 to revise and redesignate the provision into new ¶¶ (A) and (B) to read as follows:

Responsibility

2-101.11 Assignment. *

  1. (A) Except as specified in ¶ (B) of this section, the PERMIT HOLDER shall be the PERSON IN CHARGE or shall designate a PERSON IN CHARGE and shall ensure that a PERSON IN CHARGE is present at the food establishment during all hours of operation.
  2. (B) In a food establishment with two or more separately permitted departments that are the legal responsibility of the same permit holder and that are located on the same premises, the permit holder may, during specific time periods when food is not being prepared, packaged, or served, designate a single person in charge who is present on the premises during all hours of operation, and who is responsible for each separately permitted food establishment on the premises.

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:

 

Amendments, Additions, Deletions to Chapter 3 Food

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.

  1. (A) Raw SHUCKED SHELLFISH shall be obtained in nonreturnable packages which bear a legible label that identifies the:
    1. (1) Name, address, and CERTIFICATION NUMBER of the shucker, packer or repacker of the MOLLUSCAN SHELLFISH; and
    2. (2) The "sell by" or "best if used by" date for packages with a capacity of less than 1.89 L (one-half gallon) or the date shucked for packages with a capacity of 1.89 L (one-half gallon) or more.
  2. (B) No Change

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.*

  1. (A)SHELLSTOCK shall be obtained in containers bearing legible source identification tags or labels that are affixed by the harvester or dealer that depurates, ships, or reships the SHELLSTOCK, as specified in the National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish, and that list:
    1. (1) No change
    2. (2) Except as specified in ¶ (D) of this section, on each dealer's tag or label, the following information in the following order:
      1. (a) The dealer's name and address, and the certification number assigned by the shellfish control authority,
      2. (b - d) No change.
  2. (B) No Change.
  3. (C) If a place is provided on the harvester's tag or label for a dealer's name, address, and certification number, the dealer's information shall be listed first.
  4. (D) If the harvester's tag or label is designed to accommodate each dealer's identification as specified under Subparagraphs (A)(2)(a) and (b) of this section, individual dealer tags or labels need not be provided.

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.*

  1. (A) Except as specified under Subparagraph (C) (2) of this section, shellstock tags or labels shall remain attached to the container in which the shellstock are received until the container is empty.
  2. (B) The date when the last shellstock from the container is sold or served shall be recorded on the tag or label.
  3. (C) The identity of the source of shellstock that are sold or served shall be maintained by retaining shellstock tags or labels for 90 calendar days from the date that is recorded on the tag or label, as specified under ¶ B of this section, by:
    1. (1) Using an approved record keeping system that keeps the tags or labels in chronological order correlated to the date that is recorded on the tag or label, as specified under ¶ B of this section; and
    2. (2) If shellstock are removed from its tagged or labeled container:
      1. (a) Preserving source identification by using a record keeping system as specified under Subparagraph (C)(1) of this section, and
      2. (b) Ensuring that shellstock from one tagged or labeled container are not commingled with shellstock from another container with different certification numbers; different harvest dates; or different growing areas as identified on the tag or label before being ordered by the consumer.

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.*

  1. (A) Except as specified under ¶¶ (B) and (C) and in ¶ (E) of this section, potentially hazardous food (time/temperature control for safety food) that is cooked, cooled, and reheated for hot holding shall be reheated so that all parts of the food reach a temperature of at least 74°C (165°F) for 15 seconds.
  2. (B) Except as specified under ¶ (C) of this section, potentially hazardous food (time/temperature control for safety food) reheated in a microwave oven for hot holding shall be reheated so that all parts of the food reach a temperature of at least 74°C (165°F) and the food is rotated or stirred, covered, and allowed to stand covered for 2 minutes after reheating.
  3. (C) ready-to-eat food taken from a commercially processed, hermetically sealed container, or from an intact package from a food processing plant that is inspected by the food regulatory authority that has jurisdiction over the plant, shall be heated to a temperature of at least 57°C (135°F) for hot holding.
  4. (D) Reheating for hot holding as specified under ¶¶ (A) - (C) of this section shall be done rapidly and the time the food is between 5°C (41°F) and the temperatures specified under ¶¶ (A) - (C) of this section may not exceed 2 hours.

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:

  1. (A) Under refrigeration that maintains the FOOD temperature at 5°C (41°F) or less; or
  2. (B) At any temperature if the FOOD remains frozen.

3-501.13 Thawing.

Except as specified in ¶ (D) of this section, potentially hazardous food (time/temperature control for safety food) shall be thawed:

  1. (A) Under refrigeration that maintains the food temperature at 5°C (41°F) or less; or
  2. (B) Completely submerged under running water:
    1. (1) At a water temperature of 21°C (70°F) or below,
    2. (2) With sufficient water velocity to agitate and float off loose particles in an overflow, and
    3. (3) For a period of time that does not allow thawed portions of ready-to-eat food to rise above 5°C (41°F), or
    4. (4) For a period of time that does not allow thawed portions of a raw animal food requiring cooking as specified under ¶ 3 401.11(A) or (B) to be above 5°C (41°F) for more than 4 hours including:
      1. (a) The time the food is exposed to the running water and the time needed for preparation for cooking, or
      2. (b) The time it takes under refrigeration to lower the food temperature to 5°C (41°F);

3-501.14 Cooling.*

  1. (A) Cooked potentially hazardous food (time/temperature control for safety food) shall be cooled:
    1. (1) Within 2 hours from 57°C (135°F) to 21°C (70°F); and
    2. (2) Within a total of 6 hours from 57°C (135°F) to 5°C (41°F) or less.
  2. (B) potentially hazardous food (time/temperature control for safety food) shall be cooled within 4 hours to 5°C (41°F) or less if prepared from ingredients at ambient temperature, such as reconstituted foods and canned tuna.
  3. (C) Except as specified under ¶ (D) of this section, a potentially hazardous food (time/temperature control for safety food) received in compliance with laws allowing a temperature above 5°C (41°F) during shipment from the supplier as specified in ¶ 3 202.11(B), shall be cooled within 4 hours to 5°C (41°F) or less.

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.*

  1. (A) Except during preparation, cooking, or cooling, or when time is used as the public health control as specified under §3 501.19, and except as specified under ¶ (B) and in ¶ (C ) of this section, potentially hazardous food (time/temperature control for safety food) shall be maintained:
    1. (1) At 57°C (135°F) or above, except that roasts cooked to a temperature and for a time specified in ¶ 3 401.11(B) or reheated as specified in ¶ 3-403.11(E) may be held at a temperature of 54°C (130°F) or above; or
    2. (2) At 5°C (41°F) or less.
  2. (B) Eggs that have not been treated to destroy all viable Salmonellae shall be stored in refrigerated equipment that maintains an ambient air temperature of 7°C (45°F) or less.
  3. (C) potentially hazardous food (time/temperature control for safety food) in a homogenous liquid form may be maintained outside of the temperature control requirements, as specified under ¶ (A) of this section, while contained within specially designed equipment that complies with the design and construction requirements as specified under ¶ 4-204.13(E).

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.*

  1. (A) Except when packaging food using a reduced oxygen packaging method as specified under § 3-502.12, and except as specified in ¶¶ (D) and (E) of this section, refrigerated, ready-to-eat, potentially hazardous food (time/temperature control for safety food) prepared and held in a food establishment for more than 24 hours shall be clearly marked to indicate the date or day by which the food shall be consumed on the premises, sold, or discarded when held at a temperature of 5°C (41°F) or less for a maximum of 7 days.
  2. (B) through (F) – No change.

Amend §3-501.19 to revise to read as follows:

3-501.19 Time as a Public Health Control.*

  1. (A) Except as specified under ¶ (D) of this section, if time without temperature control is used as the public health control for a working supply of potentially hazardous food (time/temperature control for safety food) before cooking, or for ready-to-eat potentially hazardous food (time/temperature control for safety food) that is displayed or held for sale or service:
    1. (1) Written procedures shall be prepared in advance, maintained in the food establishment and made available to the  regulatory authority upon request that specify:
      1. (a) Methods of compliance with Subparagraphs (B)(1)-(3) or (C)(1)-(5) of this section; and
      2. (b) Methods of compliance with § 3-501.14 for food that is prepared, cooked, and refrigerated before time is used as a public health control.
  2. (B) If time without temperature control is used as the public health control up to a maximum of 4 hours:
    1. (1) The food shall have an initial temperature of 5°C (41°F) or less when removed from cold holding temperature control, or 57°C (135°F) or greater when removed from hot holding temperature control;
    2. (2) The food shall be marked or otherwise identified to indicate the time that is 4 hours past the point in time when the food is removed from temperature control;
    3. (3) The food shall be cooked and served, served at any temperature if ready-to-eat, or discarded, within 4 hours from the point in time when the food is removed from temperature control; and
    4. (4) The food in unmarked containers or packages, or marked to exceed a 4-hour limit shall be discarded.
  3. (C) If time without temperature control is used as the public health control up to a maximum of 6 hours:
    1. (1) The food shall have an initial temperature of 5°C (41°F) or less when removed from temperature control and the food temperature may not exceed 21°C (70°F) within a maximum time period of 6 hours;
    2. (2) The food shall be monitored to ensure the warmest portion of the food does not exceed 21°C (70°F) during the 6-hour period, unless an ambient air temperature is maintained that ensures the food does not exceed 21°C (70°F) during the 6-hour holding period;
    3. (3) The food shall be marked or otherwise identified to indicate:
      1. (a) The time when the food is removed from 5°C (41°F) or less cold holding temperature control, and
      2. (b) The time that is 6 hours past the point in time when the food is removed from cold holding temperature control;
    4. (4) The food shall be:
      1. (a) Discarded if the temperature of the food exceeds 21°C (70°F), or
      2. (b) Cooked and served, served at any temperature if ready-to-eat, or discarded within a maximum of 6 hours from the point in time when the food is removed from 5°C (41°F) or less cold holding temperature control; and
    5. (5) The food in unmarked containers or packages, or marked with a time that exceeds the 6-hour limit shall be discarded.
  4. (D) A food establishment that serves a highly susceptiblepopulation may not use time as specified under ¶¶ (A), (B) or (C) of this section as the public health control for raw eggs.

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.*

  1. (D) Except as specified under ¶ (C) of this section, a food establishment may package food using a cook-chill or sous vide process without obtaining a variance if:
    1. (1) The food establishment implements a HACCP plan that contains the information as specified under ¶ 8-201.14(D);
    2. (2) The food is:
      1. (a) Prepared and consumed on the premises, or prepared and consumed off the premises but within the same business entity with no distribution or sale of the bagged product to another business entity or the consumer,
      2. (b) Cooked to heat all parts of the food to a temperature and for a time as specified under § 3-401.11,
      3. (c) Protected from contamination after cooking as specified under Part 3-4,
      4. (d) Placed in a package or bag with an oxygen barrier and sealed before cooking, or placed in a package or bag and sealed immediately after cooking, and before reaching a temperature below 57°C (135°F),
      5. (e.) Cooled to 5°C (41°F) in the sealed package or bag as specified under §3-501.14, and subsequently:
        1. (i) Cooled to 1°C (34°F) within 48 hours of reaching 5°C (41°F) and held at that temperature until consumed or discarded within 30 days after the date of preparation;
        2. (ii) Cooled to 1°C (34°F) within 48 hours of reaching 5°C (41°F), removed from refrigeration equipment that maintains a 1°C (34°F) food temperature and then held at 5°C (41°F) or less for no more than 72 hours, at which time the food must be consumed or discarded;
        3. (iii) Cooled to 3°C (38°F) or less within 24 hours of reaching 5°C (41°F) and held there for no more than 72 hours from packaging, at which time the food must be consumed or discarded; or
        4. (iv) Held frozen with no shelf life restriction while frozen until consumed or used.

 

Amendments, Additions, Deletions to Chapter 4 Equipment, Utensils, and Linens

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:

  1. (A) The delivery tube, chute, orifice, and splash surfaces directly above the container receiving the food shall be designed in a manner, such as with barriers, baffles, or drip aprons, so that drips from condensation and splash are diverted from the opening of the container receiving the food;
  2. (B) The delivery tube, chute, and orifice shall be protected from manual contact such as by being recessed;
  3. (C) The delivery tube or chute and orifice of equipment used to vend liquid food or ice in unpackaged form to self-service consumers shall be designed so that the delivery tube or chute and orifice are protected from dust, insects, rodents, and other contamination by a self-closing door if the equipment is:
    1. (1) Located in an outside area that does not otherwise afford the protection of an enclosure against the rain, windblown debris, insects, rodents, and other contaminants that are present in the environment, or
    2. (2) Available for self-service during hours when it is not under the full-time supervision of a food employee; and
  4. (D) The dispensing equipment actuating lever or mechanism and filling device of consumer self-service beverage dispensing equipment shall be designed to prevent contact with the lip-contact surface of glasses or cups that are refilled.
  5. (E) Dispensing equipment in which potentially hazardous food (time/temperature control for safety food) in a homogenous liquid form is maintained outside of the temperature control requirements as specified under §3-501.16(A) shall:
    1. (1) be specifically designed and equipped to maintain the commercial sterility of aseptically packaged food in a homogenous liquid form for a specified duration from the time of opening the packaging within the equipment; and
    2. (2) conform to the requirements for this equipment as specified in NSF/ANSI 18-2006- Manual Food and Beverage Dispensing Equipment.

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.*

  1. (A) A machine vending potentially hazardous food (time/temperature control for safety food) shall have an automatic control that prevents the machine from vending food:
    1. (1) If there is a power failure, mechanical failure, or other condition that results in an internal machine temperature that cannot maintain food temperatures as specified under Chapter 3; and
    2. (2) If a condition specified under Subparagraph (A)(1) of this section occurs, until the machine is serviced and restocked with food that has been maintained at temperatures specified under Chapter 3.
  2. (B) When the automatic shutoff within a machine vending potentially hazardous food (time/temperature control for safety food) is activated:
    1. (1) In a refrigerated vending machine, the ambient air temperature may not exceed 5°C (41°F) for more than 30 minutes immediately after the machine is filled, serviced, or restocked; or
    2. (2) In a hot holding vending machine, the ambient air temperature may not be less than 57°C (135°F) for more than 120 minutes immediately after the machine is filled, serviced, or restocked.

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).

 

Amendments, Additions, Deletions to Annex 2 References

2. BIBLIOGRAPHY

Chapter 1 Purpose and Definitions

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:

  1. through 20. - No change.
  1. Corby, R., V. Lanni, V. Kistler, V. Dato, C. Yozviak, K. Waller, K. Nalluswami, M. Moll, Center for Food Safety and applied Nutrition, Office of Crisis Management, Food and Drug Admin., J. Lockett, S. Montgomery, M. Lynch, C. Braden, S.K. Gupta and A. DuBois. 2005. Outbreaks of Salmonella Infections Associated with Eating Roma Tomatoes --- United States and Canada, 2004 MMWR, April 8, 2005, 54(13):325-328.
  2. Guo, X., J. Chen, R.E. Brackett and L.R. Beuchat. 2001. Survival of Salmonellae on and in Tomato Plants from the Time of Inoculation at Flowering and Early Stages of Fruit Development through Fruit Ripening. Appl. And Env. Microbiol. 67(10):4760-4764.
  3. Zhuang, R.-Y., L.R. Beuchat and F.J. Angulo. 1995. Fate of Salmonella Montevideo on and in Raw Tomatoes as Affected by Temperature and Treatment with Chlorine. Appl. And Env. Microbiol. 61(6):2127-2131.
  4. Retail Food Protection Program Information Manual entitled, "Storage and Handling of Tomatoes", 2007.
    www.cfsan.fda.gov/~ear/pimtomat.html
Chapter 4 Equipment, Utensils, and Linens

Amend references for §4-204.13 to add new reference for §4-204.13 to read as follows:

  1. NSF/ANSI 18-2007 Manual Food and Beverage Dispensing Equipment. NSF International

3.Supporting Documents

Amendments, Additions, Deletions to Annex 2 Chapter 1

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.

 

Amendments, Additions, Deletions to Annex 3  Public Health Reasons/ Administrative Guidelines

Chapter 1 Purpose and Definitions

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:

  • process technologies other than heat are applied to destroy foodborne pathogens (e.g., irradiation, high pressure processing, pulsed light, ozonation);
  • combination products are prepared; or
  • other extrinsic factors (e.g., packaging/atmospheres) or intrinsic factors (e.g., redox potential, salt content, antimicrobials) are used to control or eliminate pathogen growth.

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:

  • Is the intent to hold the food without using time or temperature control?
    • If the answer is No, no further action is required. The decision tree later in this Annex is not needed to determine if the item is a PHF/TCS food.
  • Is the food raw, or is the food heat-treated?
  • Does the food already require time/temperature control for safety by definition in paragraph 1-201.10(B)?
  • Does a product history with sound scientific rationale exist indicating a safe history of use?
  • Is the food processed and packaged so that it no longer requires TCS such as ultra high temperature (UHT) creamers or shelf-stable canned goods?
  • What is the pH and aw of the food in question using an independent laboratory and Association of Official Analytical Chemists (AOAC) methods of analysis?

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

Chapter 2 Management and Personnel

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:

  1. Does the establishment have an Employee Health Policy? If so, are the food employees aware of the employee health policy, and is it available in written format and readily available for food employees? (Note: A written Employee Health Policy is not a Food Code requirement unless the facility is operating under a pre-approved alternative procedure specified under ¶ 3-301.11(D)).
  2. Does the establishment require conditional employees and food employees to report certain illnesses, conditions, symptoms, and exposures?
  3. Are the reporting requirements explained to all employees?
  4. What are the reporting requirements for conditional employees, food employees, and the food establishment manager?
  5. Are conditional employees asked if they are experiencing certain symptoms or illnesses upon offer of employment? If so, which symptoms or illnesses?
  6. If a food employee reports a diagnosis with one of the 5 listed pathogens in the Food Code, what questions are asked of the food employee? (The first question every food manager should ask a food employee who reports diagnosis with a listed pathogen is if the employee is currently having any symptoms.)
  7. Who does the establishment notify when a food employee reports a diagnosis with one of the listed pathogens?
  8. What gastrointestinal symptoms would require exclusion of a food employee from the food establishment?
  9. What history of exposure is a conditional employee or food employee required to report?
  10. If a food employee reports a gastrointestinal symptom, what criteria are used to allow the employee to return to work?

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:

2-201.12 Table 1b: Summary of Requirements for Diagnosed Symptomatic Food Employees

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.

DiagnosisEXCLUSION
Facilities Serving HSP or not Serving HSP
Removing diagnosed, symptomatic food employees from exclusionRA Approval Needed to Return to Work?
Hepatitis A virusEXCLUDE 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:
  • The food employee has been jaundiced for more than 7 calendar days 2-201.13(B)(1), or
  • The anicteric food employee has had symptoms or more than 14 days 2-201.13(B)(2), or
  • The food employee provides medical documentation 2-201.13(B)(3) (also see Table 2).
Yes
Typhoid Fever (S. Typhi)EXCLUDE
2-201.12(C)
When approval is obtained from the RA 2-201.13(C)(1), and:
  • Food employee provides medical documentation, that states the food employee is free of a S. Typhi infection 2-201.13(C)(2) (also see Table 2).
Yes
E. coli O157:H7 or other EHEC/ STECEXCLUDE
Based on vomiting or diarrhea symptoms, under 2-201.12(A)(2)
  1. Serving Non-HSP facility: 2-201.13(A)(4)(a): Shall only work on a restricted basis 24 hours after symptoms resolve and remains restricted until meeting the requirements listed below:
  2. Serving HSP facility: 2-201.13(A)(4)(b): Remains excluded until meeting the requirements listed below:
    • Approval is obtained from RA 2-201.13(F), and
    • Medically cleared 2-201.13(F)(1), or
    • More than 7 calendar days have passed since the food employee became asymptomatic 2-201.13(F)(2) (also see Table 2).
Yes to return to HSP or to return unrestricted; Not required to work on a restricted basis in a non-HSP facility
NorovirusEXCLUDE
Based on vomiting or diarrhea symptoms, under 2-201.12(A)(2)
  1. Serving non-HSP facility: 2-201.13 (A)(2)(a): Shall only work on a restricted basis 24 hours after symptoms resolve and remains restricted until meeting the requirements listed below:
  2. Serving HSP facility: 2-201.13(A)(2)(b): Remains excluded until meeting the requirements listed below:
    • Approval is obtained from the RA 2-201.13(D), and
    • Medically cleared 2-201.13(D)(1), or
    • More than 48 hours have passed since the food employee became asymptomatic 2-201.13(D)(2) (also see Table 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)
  1. Serving Non-HSP facility: 2-201.13(A)(3)(a): Shall only work on a restricted basis 24 hours after symptoms resolve, and remains restricted until meeting the requirements listed below:
  2. Serving HSP facility: 2-201.13(A)(3)(b): Remains excluded until meeting the requirements listed below:
    • Approval is obtained from the RA 2-201.13(E), and
    • Medically cleared 2-201.13(E)(1), or
    • More than 7 calendar days have passed since the food employee became asymptomatic 2-201.13)(E)(2) (also see Table 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:

2-201.12 Table 2: Summary of Requirements for Diagnosed Food Employees with Resolved Symptoms

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 DiagnosisFacilities Serving HSPFacilities Not Serving HSPRemoving Diagnosed Food Employees with Resolved Symptoms from Exclusion or RestrictionRA 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:
  • Food employee provides medical documentation that states the food employee is free of a S. Typhi infection 2-201.13)(C)(2) (also see Table 1b).
Yes
 Shigella spp.EXCLUDE
2-201.12(E)(1)
RESTRICT
2-201.12(E)(2)
  1. Serving Non-HSP facility: 2-201.13(A)(3)(a): Shall only work on a restricted basis 24 hours after symptoms resolve, and remains restricted until meeting the requirements listed below:
  2. Serving HSP facility: 2-201.13(A)(3)(b): Remains excluded until meeting the requirements listed below:
    • Approval is obtained from the RA 2-201.13(E), and:
    • Medically cleared 2-201.13(E)(1), or
    • More than 7 calendar days have passed since the food employee became asymptomatic 2-201.13(E)(3)(a) (also see Table 1b).
Yes to return to HSP or to return unrestricted; Not required to work on a restricted basis in a non-HSP facility
NorovirusEXCLUDE
2-201.12(D)(1)
RESTRICT
2-201.12(D)(2)
  1. Serving Non-HSP facility: 2-201.13(A)(2)(a): Shall only work on a restricted basis 24 hours after symptoms resolve and remains restricted until meeting the requirements listed below:
  2. Serving HSP facility: 2-201.13(A)(2)(b): Remains excluded until meeting the requirements listed below:
    • Approval is obtained from the RA 2-201.13(D), and:
    • Medically cleared 2-201.13(D)(1), or
    • More than 48 hours have passed since the food employee became asymptomatic 2-201.13(D)(2) (also see Table 1b).
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/ STECEXCLUDE
2-201.12(F)(1)
RESTRICT
2-201.12(F)(2)
  1. Serving Non-HSP facility: 2-201.13(A)(4)(a): Shall only work on a restricted basis 24 hours after symptoms resolve and remains restricted until meeting the requirements listed below:
  2. Serving HSP facility: 2-201.13(A)(4)(b): Remains excluded until meeting the requirements listed below:
    • Approval is obtained from the RA 2-201.13(F), and:
    • Medically cleared 2-201.13(F)(1), or
    • More than 7 calendar days have passed since the food employee became asymptomatic 2-201.13(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 virusEXCLUDE 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:
  • The food employee has been jaundiced for more than 7 calendar days 2-201.13(B)(1), or
  • The anicteric food employee has had symptoms for more than 14 days 2-201.13(B)(2), or
  • The food employee provides medical documentation 2-201.13(B)(3) (see also Table 1b).
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]

Chapter 3 Food

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:

  • Shelf-life of the product....................................................14 days
  • Incubation period.............................................................56 days
  • Medical diagnosis and confirmation.....................................5 days
  • Reporting...........................................................................5 days
  • Epidemiological investigation.............................................10 days
  • Total................................................................................90 days

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.

3-501.16 - Table 1. Estimated Reduction of Cases of Listeriosis from Limits on Refrigeration Temperatures*
Maximum Refrigerator TemperatureCases of Listeriosisa
Median55th Percentile95th Percentile
Baselineb21053/4c3/4c
7°C (45°F) maximum656331761
5°C (41°F) maximum281126

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. Graph illustrating temperature of refrigerated products at retail (Audits International)

Figure 1. Temperature of refrigerated products at retail (Audits International).

Figure 2. Graph illustrating product temperatures after transport to the home (Audits International)

Figure 2. Product temperatures after transport to the home (Audits International).

Figure 3. Graph illustrating times reported for transport of grocery items from the retail outlet to the home (Audits International)

Figure 3. Times reported for transport of grocery items from the retail outlet to the home (Audits International).

The Safety of the Time as a Public Health Control Provision from Refrigeration Temperatures (41°F or less) to Ambient

As noted above, the current TPHC provision has two time provisions. Food can be kept with no temperature stipulations for 4 hours in a food establishment, at which time the food must be cooked and served, served if RTE, or discarded within the four hours. However, if food does not exceed 70°F, it may be held for 6 hours and cooked and served, served if RTE or discarded within the six hours. For foods warming from refrigeration to ambient temperatures, the data from the Audits International study outlined above, along with simulations from the USDA Pathogen Modeling Program (PMP), were used to determine the safety of the existing TPHC recommendations.

Assuming pathogen growth in foods going from refrigeration (41°F or less) to ambient temperature, the following parameters were used for the PMP simulation:

  • 65°F was used as the temperature for the entire simulation;
  • 2 hours were added to all times (4h or 6h) allowed in the current TPHC recommendation, to factor in transportation time (per the Audits International study outlined above);
  • The data were generated from PMP broth models (pH 6.8), with the minimal NaCl and no sodium nitrite.

Table 1 summarizes the predicted growth of Bacillus cereus (vegetative), Escherichia coli, Listeria monocytogenes, Salmonella spp., Shigella flexneri, and Staphylococcus aureus, using the PMP and based on the assumptions discussed above. The data predicted that less than 1-log growth would be seen for each organism, during the 8 hour time period. Thus, the data show that the current 4 and 6 hour TPHC provisions from 41°F or less to ambient, allow minimal growth of a number of pathogens of concern.

Table 1. The USDA Pathogen Modeling Program estimation of growth (Log CFU/g) of several pathogens for 6 hours or 8 hours, at 65°F.
Pathogens6 Hours8 hours
B. cereus (vegetative cells)0.620.87
E. coli0.350.52
L. monocytogenes0.470.71
Salmonella Spp.0.250.41
S. flexneri0.26*0.34*
S. aureus0.38*0.51*

* Model predictions were in 5 hour increments, the 6 and 8 hour data was extrapolated between 5 hour and 10 hour predictions.

References

Audits International. 1999. U.S. Food Temperature Evaluation. 

U.S. Department of Agriculture. 1997. Pathogen Modeling Program. USDA Agricultural Research Service, Wyndmoor, PA.

Food and Drug Administration. 2006. Growth of Clostridium perfringens inoculated into beef roasts and meatloaf (unpublished data).

End of Summary of Consumer Handling Practices study

Raw eggs

Recipes in which more than one egg is combined carry an increased risk of illness and possible serious consequences for certain people. It is due to this increased risk, and documented occurrences of foodborne illness and death among highly susceptible populations from temperature-abused raw shell eggs contaminated with Salmonella Enteritidis, that the use of time as a public health control in institutional settings is not allowed.

3-502.12 Reduced Oxygen Packaging, Criteria

Amend Public Health Reasons for § 3-502.12 to revise existing paragraphs 6, 7, and 8 to read as follows:

When the food to be packaged under reduced oxygen conditions cannot reliably depend on secondary barriers such as aw, pH, nitrite in cured meat products, high levels of competing microorganisms or intrinsic factors in certain cheeses, time/temperature becomes the critical controlling factor for growth of C. botulinum and L. monocytogenes. Non-proteolytic C. botulinum spores are able to germinate and produce toxin at temperatures down to 3°C (38°F). Therefore, to control for toxin production by C. botulinum, an anaerobe, ROP foods must be held at 3°C (38°F) or less. Listeria monocytogenes is able to grow, although very slowly, at temperatures down to - 1°C (30°F). The lag phase and generation time of both pathogens becomes shorter as the storage temperature increases. In ¶ 3-502.12(D), cook-chill processing where food is cooked then sealed in a barrier bag while still hot and sous vide processing where food is sealed in a barrier bag and then cooked, both depend on time/temperature alone as the only barrier to pathogenic growth. Therefore, monitoring critical limits including those established for cooking to destroy vegetative cells, cooling to prevent outgrowth of spores/toxin production, and maintaining cold storage temperatures to inhibit growth and/or toxin production of any surviving pathogens is essential. Four separate options are provided in (D)(2)(e). These time-temperature combinations will provide equivalent food safety protection without need for a variance. The first is cooling the bagged product to 1°C (34°F) and holding for up to 30 days after the product is sealed in the bag. The second is cooling bagged product to 1°C (34°F), removing product to a different refrigeration unit and holding at any temperature up to 5°C (41°F) for up to 72 hours with the total storage time not to exceed 30 days. This situation is often encountered when a central kitchen prepares and stores the bagged product at 1°C (34°F) then transports it to a satellite kitchen under their control where it can be held at 5°C (41°F) or less. The third option is cooling to 3°C (38°F) and holding for no more than 72 hours from packaging. The fourth option can be used without a restricted shelf life while the bagged product is held frozen until thawed to be consumed or used in another preparation

Since there are no other controlling factors for C. botulinum and L. monocytogenes in a cook-chill or sous vide packaging system, temperature control must be continuously monitored electronically and visually examined twice daily to verify that refrigeration temperatures are adequate. New technology makes it relatively easy to continuously and electronically monitor temperatures of refrigeration equipment used to hold cook chill and sous vide products at 1°C (34°F) or 3°C (38°F) or less. Thermocouple data loggers can connect directly with commonly available thermocouple probes. Recording charts are also commonly used. Temperature monitors and alarm systems will activate an alarm or dialer if temperatures rise above preset limits. Nickel-sized data loggers are available to record temperatures which can be displayed using computer software. Since surveys have shown that temperature control in home kitchens is not always adequate, food packaged using cook chill or sous vide processing methods cannot be distributed outside the control of the food establishment doing the packaging.

Time is also a factor that must be considered in ROP. The 14 day "use by" date is required label information for VP, MAP, and CAP products and cannot exceed the manufacturer's "sell by" or "use by" date. This is considered a safe time period because two barriers to growth are required to be present. When these ROP products are frozen, there is no longer a restricted 14 day shelf life. The 30 day shelf life for cook chill and sous vide is based on killing all vegetative cells in the cooking process, preventing recontamination, and then refrigerating at 34°F or less with an option of 3°C (38°F) for up to 72 hours after packaging with stringent temperature monitoring and recording requirements. These criteria allow both institutional-sized cook chill operations that may feed thousands daily, often including transportation to their satellite locations, and individual restaurants without ice banks and tumble or blast chillers to safely use cook chill and sous vide processes.

Existing paragraphs 1-5 and 9-12 - No Change.

Chapter 4 Equipment, Utensils, and Linens

Amend Public Health Reasons for § 4-204.13 to add two new paragraphs following the existing text to read as follows:

4-204.13 Dispensing Equipment, Protection of Equipment and Food.

This requirement is intended to protect both the machine-dispensed, unpackaged, liquid foods and the machine components from contamination. Barriers need to be provided so that the only liquid entering the food container is the liquid intended to be dispensed when the machine's mechanism is activated. Recessing of the machine's components and self-closing doors prevent contamination of machine ports by people, dust, insects, or rodents. If the equipment components become contaminated, the product itself will be exposed to possible contamination.

A direct opening into the food being dispensed allows dust, vermin, and other contaminants access to the food.

NSF/ANSI 18-Manual Food and Beverage Dispensing Equipment is the standard for manual food and beverage dispensing equipment which has been designed to maintain the safety of aseptically packaged fluid foods without refrigeration even after the hermetic seal is broken.

NSF/ANSI 18 was revised in 2006 to specifically address dispensing equipment designed to hold potentially hazardous food or beverages in a homogeneous liquid form without temperature control. NSF/ANSI 18 requires that such equipment designs include a number of safeguards that prevent the contamination of specially packaged food stored within the dispensing equipment. The Standard also requires that the dispensing equipment have lockout mechanisms that preclude the dispensing of the product if such safeguards fail or if a prescribed duration of storage is exceeded. The American National Standards Institute (ANSI) recognizes NSF/ANSI 18 as the sole American National Standard for the sanitary design of manual food and beverage dispensers.

Chapter 5 Water, Plumbing, and Waste

Location and Placement

5-204.11 Handwashing Sinks.*

Amend Public Health Reasons for § 5-204.11 to revise to read as follows:

Hands are a common vehicle for the transmission of pathogens to foods in an establishment. Hands can become soiled with a variety of contaminants during routine operations. The transfer of contaminants can be limited by providing food employees with handwashing sinks that are properly equipped and conveniently located.

A handwashing sink that is properly located is one that is available to food employees who are working in food preparation, food dispensing, and warewashing areas. Handwashing sinks that are blocked by portable equipment or stacked full of soiled utensils and other items, are rendered unavailable for employee use. Nothing must block the approach to a handwashing sink thereby discouraging its use, plus it must be kept clean and well stocked with soap and sanitary towels to facilitate frequent use. Therefore, a handwashing sink that is located in the immediate work area, or between work areas that the Code states must be equipped with handwashing sinks, depending upon the size and function of the facility, would be considered properly located. Such placement of handwashing sinks facilitates frequent handwashing by food employees in all work areas.

 

Amendments, Additions, Deletions to Annex 7 Model Forms, Guides, and Other Aids

Amend Annex 7, Form 1-D, Application for Bare Hand Contact Procedure, to remove the text of the first bullet under #9, Documentation of Additional Control Measures to read as follows:

FORM 1-D Application for Bare Hand Contact Procedure
(As specified in Food Code ¶ 3-301.11(D))

Please type or print legibly using black or blue ink

  1. Establishment Name:_______________________________________________________
  2. Establishment Address:_________________________________________________________
  3. Responsible Person:______________________________________________________
    Legal Representative Business
  4.  List Procedure and Specific Ready-To-Eat-Foods to be considered for use of bare hand contact with ready-to-eat foods:

    _____________________________________________________________________

    _____________________________________________________________________

  5.  Handwashing Facilities:
    1. (a) There is a handwashing sink located immediately adjacent to the posted bare hand contact procedure and the hand sink is maintained in accordance with provisions of the Code. (§ 5-205.11, § 6-301.11, § 6-301.12, § 6-301.14)
      checkbox YES checkbox NO (Include diagram, photo or other information)
    2. (b) All toilet rooms have one or more handwashing sinks in, or immediately adjacent to them, and the sinks are equipped and maintained in accordance with provisions of the Code. (§ 5-205.11, § 6-301.11, § 6-301.12, § 6-301.14)
      checkbox YES checkbox NO
  6. Employee Health Policy: The written employee health policy must be attached to this form along with documentation that food employees and conditional employees acknowledge their responsibilities. (§ 2-201.11, § 2-201.12, § 2-201.13)
  7. Employee Training:  Provide documentation that food employees have received training in:
    • The risks of contacting the specific ready-to-eat foods with bare hands
    • Personal health and activities as they relate to diseases that are transmissible through food.
    • Proper handwashing procedures to include how, when, where to wash, & fingernail maintenance. (§ 2-301.12, § 2-301.14, § 2-301.15,  § 2-302.11)
    • Prohibition of jewelry. (§ 2-303.11)
    • Good hygienic practices. (§ 2-401.11, § 2-401.12)
  8. Documentation of Handwashing Practices: Provide documentation that food employees are following proper handwashing procedures prior to food preparation and other procedures as necessary to prevent cross-contamination during all hours of operation when the specific ready-to-eat foods are prepared or touched with bare hands.
  9. Documentation of Additional Control Measures: Provide documentation to demonstrate that food employees are utilizing two or more of the following control measures when contacting ready-to-eat foods with bare hands:
    • Double handwashing;
    • Use of nailbrushes;
    • Use of hand antiseptic after handwashing;
    • Incentive programs such as paid leave encouraging food employees not to work when they are ill; or
    • Other control measures approved by the regulatory authority.

Statement of Compliance:

I certify all of the following: All food employees are individually trained in the risks of contacting ready-to-eat foods with bare hands, personal health and activities as they relate to diseases that are transmissible through food, proper handwashing procedures, prohibition of jewelry, and good hygienic practices. A record of this training is kept on site. I understand that bare hand contact with ready-to-eat food is prohibited except for those items listed in section four (4) above. A handwashing sink is located immediately adjacent to the posted bare hand contact procedure. All handwashing sinks are maintained with hot water, soap, and drying devices. I understand that documentation is needed for handwashing practices and additional control measures. I understand that records to document handwashing are kept current and kept on site.

SIGNATURE:______________________   DATE:______________________
(Signature of legal representative of the facility listed above)

Regulatory Authority (RA) Use Only:

Permit Number: _____________________________________________________

File Review Conducted on History of Handwashing Compliance:
checkbox Yes checkbox No

Site Visit Conducted checkbox Yes checkbox No  Comments:  __________________________________

checkbox Approved: Effective Date: _______________ RA  name ______________________________

checkbox Not Approved: Reason for Denial:_______________________________________

Form 3-A Food Establishment Inspection Report

Amend Annex 7, Form 3-A, Food Establishment Inspection Report to revise Items #2, #3, #7, and #8 to read as follows:

  1. #2 Management, food employee and conditional employee; Knowledge, responsibilities and reporting
  2. #3 Proper use of restriction and exclusion
  3. #7 No bare hand contact with RTE foods or a pre-approved alternative procedure properly followed
  4. #8 Adequate handwashing sinks properly supplied and accessible

Page____of____

Food Establishment Inspection Report

As Governed by State Code Section XXX.XXX
Do Good County
12344 Any Street, Our Town, State, 11111

No. of Risk Factor/Intervention Violations
No. of Repeat Risk Factor/Intervention Violations Score (optional)

Establishment:
Address:
City/State:
Zip Code:
Telephone:

License/Permit #:
Permit Holder: Purpose of Inspection:
Est. Type:
Risk Category


Foodborne Illness Risk Factors and Public Health Interventions

Circle designated compliance status (IN, OUT, N/O, N/A) for each numbered item
IN=in compliance OUT=not in compliance N/O=not observed N/A=not applicable

Mark "X" in appropriate box for COS and/or R
COS=corrected on-site during inspection
R=repeat violation

 Compliance StatusRisk FactorCOS R 
1 SupervisionIN OUTPerson in charge present, demonstrates knowledge, and performs duties  
2 Employee HealthIN OUTManagement, food employee and conditional employee; Knowledge, responsibilities and reporting  
3 Employee HealthIN OUTProper use of restriction and exclusion  
4 Good Hygienic PracticesIN OUT N/OProper eating, tasting, drinking, or tobacco use  
5 Good Hygienic PracticesIN OUT N/ONo discharge from eyes, nose, and mouth  
6 Preventing Contamination by HandsIN OUT N/OHands clean & properly washed  
7 Preventing Contamination by HandsIN OUT N/A N/ONo bare hand contact with RTE foods or a pre-approved alternative procedure properly followed  
8 Preventing Contamination by HandsIN OUTAdequate handwashing sinks properly supplied and accessible  
9 Approved SourceIN OUTFood obtained from approved source  
10 Approved SourceIN OUT N/A N/OFood received at proper temperature  
11 Approved SourceIN OUTFood in good condition, safe, & unadulterated  
12 Approved SourceIN OUT N/A N/ORequired records available: shellstock tags, parasite destruction  
13 Protection from ContaminationIN OUT N/AFood separated & protected  
14 Protection from ContaminationIN OUT N/AFood-contact surfaces: cleaned & sanitized  
15 Protection from ContaminationIN OUTProper disposition of returned, previously served, reconditioned, & unsafe food  
16 Potentially Hazardous Food Time/TemperatureIN OUT N/A N/OProper cooking time & temperatures  
17 Potentially Hazardous Food Time/TemperatureIN OUT N/A N/OProper reheating procedures for hot holding  
18 Potentially Hazardous Food Time/TemperatureIN OUT N/A N/OProper cooling time & temperatures  
19 Potentially Hazardous Food Time/TemperatureIN OUT N/A N/OProper hot holding temperatures  
20 Potentially Hazardous Food Time/TemperatureIN OUT N/AProper cold holding temperatures  
21 Potentially Hazardous Food Time/TemperatureIN OUT N/A N/OProper date marking & disposition  
22 Potentially Hazardous Food Time/TemperatureIN OUT N/A N/OTime as a public health control: procedures & records  
23 Consumer AdvisoryIN OUT N/AConsumer advisory provided for raw or undercooked foods  
24 Highly Susceptible PopulationsIN OUT N/APasteurized foods used; prohibited foods not offered  
25 ChemicalIN OUT N/AFood additives: approved & properly used  
26 ChemicalIN OUTToxic substances properly identified, stored, & used  
27 Conformance with Approved ProceduresIN OUT N/ACompliance with variance, specialized process, & HACCP plan  

Risk factors are improper practices or procedures identified as the most prevalent contributing factors of foodborne illness or injury. Public Health Interventions are control measures to prevent foodborne illness or injury.

Good Retail Practices

Good Retail Practices are preventative measures to control the addition of pathogens, chemicals, and physical objects into foods.

Mark "X" in box if numbered item is not in compliance

Mark ""X"" in appropriate box for COS and/or R
COS=corrected on-site during inspection
R=repeat violation

 Compliance StatusRetail PracticeCOS R 
28 Food Identification Pasteurized eggs used where required  
29 Food Identification Water & ice from approved source  
30 Food Identification Variance obtained for specialized processing methods  
31 Food Identification Proper cooling methods used; adequate equipment for temperature control  
32 Food Identification Plant food properly cooked for hot holding  
33 Food Identification Approved thawing methods used  
34 Food Identification Thermometers provided & accurate  
35 Food Identification Food properly labeled; original container  
36 Prevention of Food Contamination Insects, rodents, & animals not present  
37 Prevention of Food Contamination Contamination prevented during food preparation, storage & display  
38 Prevention of Food Contamination Personal cleanliness  
39 Prevention of Food Contamination Wiping cloths: properly used & stored  
40 Prevention of Food Contamination Washing fruits & vegetables  
41 Proper Use of Utensils In-use utensils: properly stored  
42 Proper Use of Utensils Utensils, equipment & linens: properly stored, dried, & handled  
43 Proper Use of Utensils Single-use/single-service articles: properly stored & used  
44 Proper Use of Utensils Gloves used properly  
45 Utensils, Equipment and Vending Food & non-food contact surfaces cleanable, properly designed, constructed, & used  
46 Utensils, Equipment and Vending Warewashing facilities: installed, maintained, & used; test strips  
47 Utensils, Equipment and Vending Non-food contact surfaces clean  
48 Physical Facilities Hot & cold water available; adequate pressure  
49 Physical Facilities Plumbing installed; proper backflow devices  
50 Physical Facilities Sewage & waste water properly disposed  
51 Physical Facilities Toilet facilities: properly constructed, supplied, & cleaned  
52 Physical Facilities Garbage & refuse properly disposed; facilities maintained  
53 Physical Facilities Physical facilities installed, maintained, & clean  
54 Physical Facilities Adequate ventilation & lighting; designated areas used  

Person in Charge (Signature)
Date:

Inspector (Signature)
Follow-up: YES NO (Circle one) Follow-up Date:

Page____of____

As Governed by State Code Section XXX.XXX
Do Good County
12344 Any Street, Our Town, State, 11111
License/Permit #
 
 
Date
 
 

Establishment
Address
City/State
Zip Code
Telephone

Temperature Observations
Item/LocationTempItem/LocationTempItem/LocationTemp
      
      
      
      
      
      
Observations and Corrective Actions
Item NumberViolations cited in this report must be corrected withing the time frames below, or as stated in sections 8-405.11 of the food code.
  
  
  
  
  

Guide 3-B Food Code References for Risk Factors/Interventions and Good Retail Practices Specified on the Food Establishment Inspection Report

Amend Annex 7, Guide 3-B, Food Code References for Risk Factors/Interventions and Good Retail Practices Specified on the Food Establishment Inspection Report to revise Items #2, #3, and #45 to read as follows:

The major headings from the Food Establishment Inspection Report form have been extracted and condensed in Guide 3-B to key word phrases to assist the person conducting inspections in locating the Food Code citation that corresponds to a given violation and recording inspectional observations.

Part 1. Risk Factors and Interventions

Supervision
  1. 1.
    1. 2-101.11 Assignment *
    2. 2-102.11 Demonstration *
    3. 2-103.11 Person-In-Charge (PIC) Duties
Employee Health
  1. 2.
    1. 2-201.11(A), (B), (C), & (E) Responsibility of PIC, Conditional & Food Employees *
    2. 2-103.11(M) Food Employees & Conditional Employees Informed of Reporting responsibilities
  2. 3.
    1. 2-201.12 Exclusions & Restrictions *
    2. 2-201.13 Removal of Exclusions & Restrictions
    3. 2-201.11 (D) Responsibility of PIC to Exclude or Restrict
    4. 2-201.11 (F) Responsibility of Food Employee to Comply
Good Hygienic Practices
  1. 4.
    1. 2-401.11 Eating, Drinking, or Using Tobacco *
    2. 3-301.12 Preventing Contamination when Tasting *
  2. 5.
    1. 2-401.12 Discharges from the Eyes, Nose, and Mouth *
Control of Hands as a Vehicle of Contamination
  1. 6.
    1. 2-301.11 Clean condition *
    2. 2-301.12 Cleaning Procedure *
    3. 2-301.14 When to Wash *
    4. 2-301.15 Where to Wash
    5. 2-301.16 Hand Antiseptics
  2. 7.
    1. 3-301.11 Preventing Contamination from Hands *
  3. 8.
    1. 5-203.11 Handwashing Sinks (nos./capacities) *
    2. 5-204.11 Handwashing Sinks (loc./placement) *
    3. 5-205.11 Using a Handwashing Sink
    4. 6-301.11 Handwashing Cleanser, Availability
    5. 6-301.12 Hand Drying Provision
    6. 6-301.13 Handwashing Aids & Devices, Use Restrictions
    7. 6-301.14 Handwashing Signage
    8. 6-501.18 Maintaining & Using Handwashing Sinks
Approved Source
  1. 9.
    1. 3-201.11 Compliance with Food Law *
    2. 3-201.12 Food in Hermetically Sealed Container *
    3. 3-201.13 Fluid Milk & Milk Products *
    4. 3-201.14 Fish *
    5. 3-201.15 Molluscan Shellfish *
    6. 3-201.16 Wild Mushrooms *
    7. 3-301.17 Game Animals *
    8. 3-202.13 Eggs *
    9. 3-202.14 Eggs & Milk Products, Pasteurized *
    10. 3-202.110 Prepackaged Juice-Treated
    11. 5-101.13 Bottled Drinking Water *
  2. 10.
    1. 3-202.11 Temperature *
  3. 11.
    1. 3-101.11 Safe, Unadulterated & Honestly Presented *
    2. 3-202.15 Package Integrity *
  4. 12.
    1. 3-202.18 Shellstock Identification *
    2. 3-203.12 Shellstock, Maintaining Identification *
    3. 3-402.11 Parasite Destruction *
    4. 3-402.12 Records, Creation, & Retention
Protection from Contamination
  1. 13.
    1. 3-302.11 Separation, Packaging, & Segregation *
    2. 3-304.11 Food Contact with Equipment & Utensils *
    3. 3-306.13(A) Consumer Self Service Operations *
  2. 14.
    1. 4-501.111 Manual Warewashing, Hot Water Sanitization *
    2. 4-501.112 Mechanical Warewashing, Hot Water Sanitization
    3. 4-501.113 Mechanical Warewashing, Sanitization Pressure
    4. 4-501.114 Chemical Sanitization-Temp, pH, Concentration, Hardness *
    5. 4-501.115 Manual Warewashing Eqip. Detergent Sanitizers
    6. 4-601.11(A) Food Contact Surface Clean to Sight & Touch *
    7. 4-602.11 Food Contact Surface-Cleaning Frequency *
    8. 4-602.12 Cooking & Baking Equipment
    9. 4-702.11 Before Use After Cleaning *
    10. 4-703.11 Hot Water and Chemical *
  3. 15.
    1. 3-306.14 Returned Food & Re-service of Food *
    2. 3-801.11 Discarding/Reconditioning Adulterated Food *
Potentially Hazardous Food (Time/Temperature Control for Safety Food)
  1. 16.
    1. 3-401.11 Cooking Raw Animal Foods *
    2. 3-401.12 Microwave Cooking *
  2. 17.
    1. 3-403.11 Reheating for Hot Holding *
  3. 18.
    1. 3-501.14 Cooling *
  4. 19.
    1. 3-501.16 Hot Holding *
  5. 20.
    1. 3-501.16 Cold Holding *
  6. 21.
    1. 3-501.17 RTE PHF (TCS Food), Date Marking1
    2. 3-501.18 RTE PHF (TCS Food), Disposition *
  7. 22.
    1. 3-501.19 Time as a Public Health Control *
Consumer Advisory
  1. 23.
    1. 3-603.11 Consumer Advisory for Raw/ Undercooked Food*
Highly Susceptible Populations
  1. 24.
    1. 3-801.11 Pasteurized Foods & Prohibited Food *
Chemical
  1. 25.
    1. 3-202.12 Approved Additives *
    2. 3-302.14 Protection from Unapproved Additives *
  2. 26.
    1. 7-101.11 Identifying Information*
    2. 7-102.11 Common Name, Working Containers *
    3. 7-201.11 Separation, Storage *
    4. 7.202.11 Restriction *
    5. 7-202.12 Conditions of use *
    6. 7-203.11 Poisonous or Toxic Material Containers *
    7. 7-204.11 Sanitizers, Criteria *
    8. 7-204.12 Chemicals for Washing Fruits & Vegetables *
    9. 7-204.13 Boiler Water Additives *
    10. 7-204.14 Drying Agents *
    11. 7-205.11 Incidental Food Contact, Criteria*
    12. 7-206.11 Restricted Use Pesticides *
    13. 7-206.12 Rodent Bait Stations *
    14. 7-206.13 Tracking Powders, Pest Control & Monitoring*
    15. 7-207.11 Restriction & Storage; Medicines *
    16. 7-207.12 Refrigerated Medicines, Storage *
    17. 7-208.11 Storage-First Aid Supplies *
    18. 7-209.11 Storage-Personal Care Items
    19. 7-301.11 Separation-for Retail Sale*
Conformance with Approved Procedures
  1. 27.
    1. 3-502.11 Variance Requirement *
    2. 3-502.12 Reduced Oxygen Packaging, Criteria *
    3. 3-404.11 Treating Juice
    4. 8-103.12 Compliance with Variance and HACCP Plan *
Safe Food & Water
  1. 28. Pasteurized eggs used where required
    1. 3-302.13 Pasteurized eggs substituted for raw eggs in uncooked, egg-based recipes
  2. 29. Water & ice from approved source
    1. 3-202.16 Ice used as a food/cooling medium made from potable water*
    2. 5-101.11 Drinking water from an approved source*
    3. 5-102.11 Standards of quality for public drinking water met*
    4. 5-102.12 Nondrinking water used only for non-food purposes*
    5. 5-102.13 Sampling report for non-public water tested as required
    6. 5-102.14 Recent report available
    7. 5-104.12 Alternative water supply delivered through approved means
  3. 30. Variance obtained for specialized processing methods
    1. 8-103.11 Documentation & justification for variance on file with regulatory authority
Food Temperature Control
  1. 31. Proper cooling methods used; adequate equipment for temperature control
    1. 3-501.11 Frozen food stored frozen
    2. 3-501.15 Proper cooling methods used for PHF(TCS Foods)
    3. 4-301.11 Cooling, heating, & holding equipment sufficient in number, capacity & in good repair
  2. 32. Plant food properly cooked for hot holding
    1. 3-401.13 Plant food (vegetables/fruit) cooked to 135°F or above for hot holding
  3. 33. Approved thawing methods used
    1. 3-501.12 Frozen PHF (TCS Foods) slacked properly;
    2. 3-501.13 Proper thawing methods used for PHF(TCS Foods)
  4. 34. Thermometers provided & accurate
    1. 4-203.11 Food thermometers accurate in the intended range of use
    2. 4-203.12 Ambient air & water thermometers accurate in the intended range of use
    3. 4-204.112 Thermometers located in refrigerators/hot holding units to measure ambient air in warmest/coolest areas of units
    4. 4-302.12 Food thermometers provided & accessible; Appropriate thermometer for measuring thin foods provided
Food Identification
  1. 35. Food properly labeled; original container
    1. 3-202.17 Proper identification & sell-by date on packages of shucked shellfish
    2. 3-203.11 Molluscan shellfish stored in original container until sold/prepped
    3. 3-302.12 Food storage containers identified with common name of food
    4. 3-305.13 Vended PHF (TCS Foods) dispensed in original container
    5. 3-601.11 Standards of identity met for packaged foods
    6. 3-601.12 Foods honestly presented, do not misinform consumers
    7. 3-602.11 Food packaged in the food establishment labeled as specified in law
    8. 3-602.12 Consumer warnings as required by law on labels
Prevention of Food Contamination
  1. 36. Insects, rodents, & animals not present
    1. 2-403.11 Food employees not handling animals*
    2. 6-202.13 Insect control devices properly designed & installed
    3. 6-202.15 Openings to outside protected against entry of pest;
    4. 6-202.16 Protective barriers provided for exterior walls/roofs
    5. 6-501.111 Effective pest control measures in place*
    6. 6-501.112 Dead or trapped pest removed traps at adequate frequency
    7. 6-501.115 Prohibited live animals not on premises*
  2. 37. Contamination prevented during food preparation, storage, & display
    1. 3-202.19 Shellstock free of mud, dead shellfish & shellfish with broken shells
    2. 3-303.11 Ice as a coolant not used as food
    3. 3-303.12 Packaged food not stored in direct contact with water/ice during display
    4. 3-304.13 Linens & napkins not used in contact with food unless as a liner & replaced each time
    5. 3-305.11 Food stored 6" off the floor in clean, dry location
    6. 3-305.12 Food not stored in prohibited areas
    7. 3-305.14 Unpackaged food protected from environmental contamination during preparation
    8. 3-306.11 Food on display protected by food guards/packaging
    9. 3-306.12 Condiments protected in dispensers/individual packets
    10. 3-306.13(B) Consumer self-service operations provided with suitable utensilsN
    11. 3-306.13(C) Consumer self-service operations monitoredN
    12. 3-307.11 Food not contaminated by any other source
    13. 6-404.11 Distressed food segregated & properly located away from food, utensils, or equipment
  3. 38. Personal cleanliness
    1. 2-302.11 Fingernails neat & trimmed; Gloves worn over polished nails & artificial nails
    2. 2-303.11 No jewelry worn during food handling except plain wedding band
    3. 2-304.11 Outer clothing clean
    4. 2-402.11 Hair restraints & clothes that cover body hair worn by food employees
  4. 39. Wiping cloths properly used & stored
    1. 3-304.14 Cloths for spills used for only one purpose; wet wiping cloths stored in sanitizer; wet & dry cloths stored clean
    2. 4-101.16 Sponges not used on sanitized food contact surfaces
    3. 4-901.12 Wiping cloths laundered in establishment, air dried if no clothes dryer present
  5. 40. Washing fruits & vegetables
    1. 3-302.15 Raw fruits & vegetables thoroughly washed before use
Proper Use of Utensils
  1. 41. In-use utensils properly stored
    1. 3-304.12 In-use utensils properly stored between uses
  2. 42. Utensils, equipment, & linens properly stored, dried, & handled
    1. 4-801.11 Clean linens free of food residues & soil
    2. 4-802.11 Based on use, linens laundered at adequate frequency
    3. 4-803.11 Soiled linens properly stored
    4. 4-803.12 Linens mechanically washed unless only wiping cloths are laundered on site
    5. 4-901.11 Equipment/utensils air dried after washing, rinsing, & sanitizing
    6. 4-903.11 Equipment/utensils/linens stored 6'' off floor in clean, dry location
    7. 4-903.12 Equipment/utensils/linens not stored in prohibited areas
    8. 4-904.11 Kitchenware/tableware handled to protect food-/lip-contact surfaces
    9. 4-904.12 Soiled tableware removed from eating areas
    10. 4-904.13 Preset tableware wrapped/covered; unused settings removed from table
  3. 43. Single-service & single-use articles properly stored & used
    1. 4-502.12 Single-service items available if no warewashing facilities present *
    2. 4-502.13 Single-service/-use items not reused
    3. 4-502.14 Molluscan/crustacean shells used only once as serving container
    4. 4-903.11 Single-service/use items stored 6" off the floor in a clean, dry location
    5. 4-903.12 Single-service/-use items not stored in prohibited areas/specified places
    6. 4-904.11 Single-service/-use items properly handled to protect food-/lip-contact surfaces
  4. 44. Gloves used properly
    1. 3-304.15 Single-use gloves only used for one task; Appropriate gloves used for task being performed
Utensils, Equipment, and Vending
  1. 45. Food- & nonfood-contact surfaces cleanable, properly designed, constructed, & used
    1. 3-304.16 Clean tableware for seconds provided to self-service consumers
    2. 3-304.17 Returnables not refilled at food establishment
    3. 4-101.11 Utensils/food-contact surfaces made of safe, durable, smooth materials*
    4. 4-101.12 Cast iron not used for food-contact surfaces, unless it meets exemptions
    5. 4-101.13 Lead, Use limitations,
    6. 4-101.14 Copper not used for food-contact surfaces*
    7. 4-101.15 Galvanized metal not used for food-contact surfaces*
    8. 4-101.17 Wood, Use limitations
    9. 4-101.18 Nonstick Coatings, Use Limitations
    10. 4-101.19 Nonfood-contact surfaces
    11. 4-102.11 Characteristics
    12. 4-201.11 Equipment and Utensil Durability and Strength
    13. 4-201.12 Food Temperature Measuring Devices*
    14. 4-202.11- .12 Food-contact surfaces smooth & easily accessible for cleaning;* CIP equipment easily cleanable
    15. 4-202.13 "V" threads only used for hot oil equipment
    16. 4-202.14 Hot Oil Filtering Equipment
    17. 4-202.15 Cutting parts of can opener readily removable for cleaning/replacement
    18. 4-202.16 Nonfood-contact surfaces
    19. 4-202.17 Kick plates removable for cleaning
    20. 4-204.12 Covers/lids for equipment openings overlap the opening & sloped to drain
    21. 4-204.15 Equipment requiring lubricants designed so that lubricants do not drip into food
    22. 4-204.16 Beverage tubing not in contact with stored ice
    23. 4-204.17 Liquid waste drains do not pass through ice storage bins
    24. 4-204.18 Condenser unit separated from food storage space
    25. 4-204.19 Can openers on vending machines protected from contamination
    26. 4-204.110 Molluscan shellfish tanks marked for display only or operated under a HACCP plan
    27. 4-204.13 Dispensing equipment designed to protect unpackaged product
    28. 4-204.14 Vending machine equipped with self-closing door or cover
    29. 4-204.111 Vending machines for PHF (TCS Foods) equipped with auto shutoff *
    30. 4-204.121 Vending machines for liquids equipped with drains, internal waste receptacle, & automatic shutoff
    31. 4-204.122 Case lot handling apparatuses, Moveablility,
    32. 4-204.123 Vending machine doors/openings tight-fitting
    33. 4-302.11 Dispensing utensils provided for each container of food at a co consumer self-service unit
    34. 4-401.11 Equipment, washers/dryers, linen, & storage cabinets properly located
    35. 4-402.11 Fixed or counter-mounted equipment properly spaced or sealed
    36. 4-402.12 Fixed or counter-mounted equipment properly elevated or sealed
    37. 4-501.11 Equipment in good repair & adjusted per manufacturer's specs
    38. 4-501.12 Scratched cutting boards resurfaced or discarded
    39. 4-501.13 Microwave ovens meeting safety standards specified in CFR
    40. 4-502.11 Utensils maintained in good repair; thermometers calibrated per manufacturer's specs
    41. 4-603.11 Dry cleaning methods used with non PHF (non TCS Foods) only
    42. 4-603.17 Cleaning/refilling of returnables only for non PHF (non TCS Foods) or conducted at a regulated facility*
    43. 4-902.11 Food-contact surfaces not contaminated during lubricating of equipment
    44. 4-902.12 Food-contact surfaces not contaminated during reassembly of equipment
  2. 46. Warewashing facilities installed, maintained, & used; test strips
    1. 4-203.13 Hot water pressure devices accurate to ± 2 pounds per square inch
    2. 4-204.113 - .116 Data plate/baffles/thermometers on warewashing machines; heater/basket present for manual heat sanitization
    3. 4-204.117 Warewashing machine equipped with means to verify dispensing of detergents & sanitizers
    4. 4-204.118 - .120 Pressure device on machines with hot water sanitizing rinse; sinks, drainboards, compartments self-draining
    5. 4-301.12 3 compartment sink large enough to immerse largest utensil
    6. 4-301.13 Adequate drainboards provided
    7. 4-302.13- .14 Thermometer for testing sanitizing water temperature &/or test kit for measuring sanitizer concentration provided
    8. 4-501.14 Warewashing equipment cleaned before use & every 24 hours
    9. 4-501.15 Warewashing machine operated per data plate
    10. 4-501.16 Warewashing sinks cleaned & sanitized before & after use for washing food or wiping cloths
    11. 4-501.17 Cleaning agents used for washing utensils in accordance with manufacturer's instructions
    12. 4-501.18 Wash, rinse & sanitize solutions maintained clean
    13. 4-501.19 Manual wash temperature maintained ≥110°F
    14. 4-501.110 Wash temperature requirement met for warewashing machine based on machine type
    15. 4-501.116 Concentration of sanitizer solution determined by use of test kit
    16. 4-603.12 Equipment/utensils precleaned before washing
    17. 4-603.13 Soiled items properly loaded into warewashing machines
    18. 4-603.14 Equipment food-contact surfaces & utensils effectively washed
    19. 4-603.15 Fixed equipment & equipment too large for warewashing sink/machine washed by approved alternative method
    20. 4-603.16 Utensils & equipment rinsed after washing
  3. 47. Nonfood-contact surfaces clean
    1. 4-601.11(B) - Equipment maintained free of encrusted (C) grease/soil deposits
    2. 4-602.13 Nonfood-contact surfaces cleaned at frequency to prevent buildup of residue
Physical Facilities
  1. 48. Hot & cold water available; adequate pressure
    1. 5-103.11 - .12 Capacity* & pressure adequate to meet facility demands
    2. 5-104.11 Water provided by public water main or approved system
  2. 49. Plumbing installed; proper backflow devices
    1. 5-101.12 Drinking water system flushed & disinfected after repair or emergency*
    2. 5-201.11 Plumbing system constructed of approved materials*
    3. 5-202.11 Plumbing system designed, constructed & installed according to law*
    4. 5-202.13 Air gap provided between water supply inlet & flood level rim of plumbing fixture*
    5. 5-202.14 Backflow prevention device designed per approved standards
    6. 5-202.15 Water filter/screen/water conditioning device installed to allow ease of cleaning
    7. 5-203.13 Service sink available for cleaning of mops & disposal of liquid waste
    8. 5-203.14 Backflow prevention device or air gap provided on plumbing fixtures as required*
    9. 5-203.15 Backflow prevention device on carbonator with no air gap*
    10. 5-204.12 - .13 Backflow prevention devices/conditioning devices located to allow service/maintenance
    11. 5-205.12 No cross connection between drinking & non-drinking water*
    12. 5-205.13 Water treatment device inspected & serviced
    13. 5-205.14 Water reservoir of fogging devices maintained & cleaned*
    14. 5-205.15 Plumbing system maintained in good repair*
    15. 5-301.11 Mobile water tank constructed of safe, durable, finished materials
    16. 5-302.11 - .16 Mobile water tank sloped to drain & designed to allow inspection & cleaning
    17. 5-303.11 - .13 Mobile water tank designed with cover for water inlet/outlet & dedicated hose connection
  3. 50. Sewage & waste water properly disposed
    1. 5-304.11 - .14 Water tank/pump/hoses properly disinfected & handled * Backflow prevention in place; waste water properly disposed
    2. 5-401.11 Mobile holding tank adequately sized for capacity & sloped to drain
    3. 5-402.11 Backflow prevention - no direct connection between sewage system & food equipment*
    4. 5-402.12 - .13 Grease trap located to allow ease of cleaning; Sewage conveyed through approved sanitary sewage system*
    5. 5-402.14 - .15 Mobile establishment waste removed through approved removal procedure; waste retention tank flushed in a sanitary manner
    6. 5-403.11 - .12 Approved sewage disposal system used for waste disposal* Other liquid wastes drained to disposal per law
  4. 51. Toilet facilities properly constructed, supplied, & cleaned
    1. 5-203.12 At least one toilet available or number specified by law *
    2. 5-501.17 Covered receptacle in women's toilet room
    3. 6-202.14 Toilet rooms completely enclosed
    4. 6-302.11 Toilet tissue supplied at each toilet
    5. 6-402.11 Toilet rooms convenient & accessible during all business hours
    6. 6-501.12 Toilet rooms & fixtures cleaned as often as necessary
    7. 6-501.19 Toilet room doors kept closed except during cleaning/maintenance
  5. 52. Garbage, refuse, recyclables, returnables properly disposed; facilities maintained
    1. 5-501.11 Outdoor storage surface constructed of nonabsorbent material & sloped to drain
    2. 5-501.12 Outdoor enclosure for refuse constructed of durable, cleanable materials
    3. 5-501.13 Receptacles durable, cleanable, insect-/rodent-resistant & leakproof
    4. 5-501.14 Receptacles not within vending machines
    5. 5-501.15 Outside receptacles designed with tight-fitting lids/doors/covers & properly installed
    6. 5-501.16 Sufficient storage capacity - & area/receptacles provided to hold refuse
    7. 5-501.18 Cleaning implements/supplies provided for effective cleaning of receptacles
    8. 5-501.19 Refuse storage areas located separate from food/utensils/equipment & not creating a nuisance
    9. 5-501.110 Receptacles for refuse, recyclables, returnables inaccessible to insects/rodents
    10. 5-501.111 Storage areas/receptacles in good repair
    11. 5-501.112 Receptacles, such as plastic bags accessible to rodents, not stored outside
    12. 5-501.113 Inside receptacles covered if not continually used; Outside receptacles equipped with tight fitting lids
    13. 5-501.114 Drain plugs provided in receptacles with drains
    14. 5-501.115 Refuse areas & enclosures maintained clean
    15. 5-501.116 Cleaning of receptacles done in way not to contaminate food/utensils/equipment
    16. 5-502.11 - .12 Refuse, recyclables, returnables removed in approved manner & at roper frequency to minimize attracting pests & developing odors
    17. 5-503.11 Refuse disposed of in an approved public or private facility
    18. 6-202.110 Outdoor refuse areas curbed & graded to drain
  6. 53. Physical facilities installed, maintained, & clean
    1. 4-301.15 Clothes washer & dryer provided for laundering conducted on premises
    2. 4-401.11(C) Washer & dryer properly located away from food/utensils/equipment
    3. 4-803.13 Laundry facilities used only for items used in the facility
    4. 6-101.11 Materials for floors/walls/ceilings smooth, durable, & easily cleanable under normal use
    5. 6-102.11 Outdoor areas surfaced with concrete/asphalt; Exterior surfaces weather-resistant
    6. 6-201.11 - .12 Floors/walls/ceilings smooth & easily cleanable; Utility lines not unnecessarily exposed
    7. 6-201.13 Floor to wall junctures coved; Water-flushed floors provided with drains & graded to drain
    8. 6-201.14 - .15 Carpeting not in areas subject to moisture; Mats/duckboards removable & easily cleanable
    9. 6-201.16 - .18 Wall & ceiling coatings/attachments easily cleanable; Studs unexposed in areas subject to moisture
    10. 6-202.17 - .19 Overhead protection at outdoor vending & servicing areas; Outdoor walking/driving surfaces graded to drain
    11. 6-202.111 - .112 Living/sleeping quarters not used for food establishment operations; living/sleeping quarters on the premises separated from food operation
    12. 6-501.11 - .12 Physical facilities maintained in good repair & cleaned as often as necessary to keep them clean
    13. 6-501.13 Floors cleaned by dustless methods
    14. 6-501.15 Mop water/maintenance tools not put in prep, handwashing, or warewashing sinks *
    15. 6-501.16 Mops allowed to air dry after use
    16. 6-501.17 Sawdust/wood shavings/granular salt/clay not used on floors
    17. 6-501.113 - .114 Maintenance tools properly stored; premises free of unnecessary items/litter
  7. 54. Adequate ventilation & lighting; designated areas provided/used
    1. 4-202.18 Ventilation filters designed for ease of cleaning & maintenance
    2. 4-204.11 Ventilation hood designed to prevent condensate from dripping onto food/equipment
    3. 4-301.14 Ventilation hood adequate to prevent grease & condensation build-up
    4. 6-202.12 Heating/ventilation/air conditioning units properly designed to prevent contamination
    5. 6-304.11 Mechanical ventilation of adequate capacity to remove steam, heat, vapors, odors, smoke, fumes
    6. 6-501.14 Ventilation system cleaned in way not to cause contamination or create a public health hazard
    7. 6-202.11 Protective shielding on light bulbs over exposed food/utensils/equipment
    8. 6-303.11 Lighting intensity adequate in food prep, storage, & service areas
    9. 6-305.11 Dressing rooms designated if employees change on-site; Lockers provided for employees
    10. 6-403.11 Designated areas for employees for eating/ drinking/smoking
    11. 6-501.110 Designated dressing rooms/lockers used by employees
Internal Cooking Temperature Specifications
145°F for 15 secondsRaw eggs cooked for immediate service
Fish, except as listed below
Meat, except as listed in the next 2 rows
Commercially raised game animals, rabbits
155°F for 15 seconds:Ratites (Ostrich, Rhea and Emu)
Injected meats
Comminuted meat, fish, or commercially raised game animals
165°F for 15 seconds:Wild game animals
Poultry
Raw eggs not for immediate service
Stuffed fish, meat, pork, pasta, ratites & poultry
Stuffing containing fish, meat, ratites & poultry

Whole Meat Roasts Refer to cooking charts in the Food Code ¶ 3-401.11(B)

Asterisk (*) items are listed as critical items in the Food Code.

1RTE PHF (TCS food) means ready-to-eat potentially hazardous food (time/temperature control for safety food).

Amendments, Additions, Deletions to GUIDE 3-C Instructions for Marking the Food Establishment Inspection Report

Amend Annex 7, Guide 3-C, Instructions for Marking the Food Establishment Inspection Report, to revise C.1. A., C.1.B., C.2., C. 3, and C. 7. to read as follows: 

GUIDE 3-C Instructions for Marking the Food Establishment Inspection Report

Guide 3-C is intended to be used during inspections to ensure that observations of the provisions of the Code are not overlooked during the inspection, and accurately recorded on the Food Code Establishment Inspection Report form.

GUIDE 3-C Instructions for Marking the Food Establishment Inspection Report

All references and code sections in these marking instructions are based on the 2005 Food Code.

A. GENERAL MARKING INSTRUCTIONS

HEADER Information

Establishment
Complete this section using the "usual/common name" or "Doing Business As" name of the business. This information should be the same as the license/permit application completed at the initiation of the business.
Address
Street address of the actual business location
Zip Code
Actual business location
Telephone
Contact phone number for the establishment
License/Permit #
License number or tracking identification
Permit Holder
Name of Owner or Operator as shown on application
Purpose
The reason for the inspection - routine, reinspection, complaint, or follow-up, etc.
Est. Type
Description or code for describing the type of facility (e.g. restaurant, market, vehicle, temporary food facility)
Risk Category
Designation of risk/priority level for determining frequency of inspection
Number of Risk Factor/ Intervention Violations
The number of boxes marked OUT in items 1-27 should be counted and the total number placed here
Number of Repeat Risk Factor/Intervention Violations
The number of boxes marked R (repeat) in items 1-27 should be counted and the total number placed here
Score (optional)
A score is optional for this form. If a jurisdiction has a scoring system, it should be incorporated into the inspection form and the score of an inspection placed here.
Date
The date of the inspection including month, day, and year
Time In
The actual time the inspection begins
Time Out
The actual time the inspection ends

B. RISK FACTORS AND INTERVENTIONS

Risk factors are food preparation practices and employee behaviors most commonly reported to the Centers for Disease Control and Prevention (CDC) as contributing factors in foodborne illness outbreaks. Risk factors include: Food from Unsafe Sources, Improper Holding Temperatures, Inadequate Cooking, Contaminated Equipment, and Poor Personal Hygiene. These items are prominent on the Food Establishment Inspection Report because maintaining these items in compliance is vital to preventing foodborne illness. Additionally, five key public health interventions were introduced in the 1993 Food Code that supplemented the other interventions long-established by the Food and Drug Administration (FDA) model codes and guidances to protect consumer health. The five key interventions are: Demonstration of Knowledge, Employee Health Controls, Controlling Hands as a Vehicle of Contamination, Time and Temperature Parameters for Controlling Pathogens, and the Consumer Advisory.

For each item on the inspection report form in the Foodborne Illness Risk Factors and Public Health Interventions section, the inspector should indicate one of the following for COMPLIANCE STATUS: "IN" which means that the item is in compliance; "OUT" which means that the item is not in compliance; " N.O." which means that the item was not observed during the inspection; or "N.A." which means that the item is not applicable for the facility. If N.A. or N.O. is not listed as an option for a particular item, this means that this item must be evaluated during the inspection and a compliance status must be determined. If the item is marked "OUT", document details of each violation for the item number in the "Observations and Corrective Actions" section on the second page of the inspection report. Compliance status should be determined as a result of observations that establish a pattern of non-compliance. Consideration should be given to the seriousness of the observation with regard to prevention of foodborne illness.

For items marked "OUT , " further indicate the status of the violation by marking an "X" in the corresponding box for Corrected On-Site ( COS) during the inspection and/or Repeat violation (R) . Marking COS indicates that all violations cited under that particular item number have been corrected and verified before completing the inspection. The actual corrective action taken for each violation should be documented in the "Observations and Corrective Actions" section of the inspection report. For example, Item #7 Handwashing sink is marked out of compliance because the establishment does not have soap and paper towels at the handwashing sink. The person in charge partially corrects the problem by putting soap at the sink, but does replace the paper towels or provide any other effective means for drying hands. The corrective action taken for the soap is documented in the narrative on the form, but COS is  not marked for Item #7 because all violations under that item were not corrected. Marking R indicates that the same violation under a particular item number was cited on the last inspection report. Using the same scenario, on the subsequent inspection if the provision of soap and paper towels is not in violation, but employees are not washing hands in the correct sink (which is also cited under Item #7 Handwashing sink), R would  not be marked because this is a new violation which was not cited on the previous inspection report.

C. Marking Instructions for each RISK FACTOR AND INTERVENTION on the Inspection Report

Supervision

1. PIC present, demonstrates knowledge, and performs duties 

IN/OUT

This item should be marked IN or OUT of compliance. The person in charge (PIC) has three assigned responsibilities - Presence; Demonstration of Knowledge; and Duties. This item is marked OUT of compliance if any  one of the responsibilities is not met.

  1. A. Person in charge is present. This item is marked OUT of compliance if there is no PIC per 2-101.11(A) and (B).
  2. B. Demonstration of Knowledge. The PIC has three options for demonstrating knowledge. This item is marked OUT of compliance if the PIC fails to meet at least  one of the options. The three options for demonstration of knowledge allowed by the Food Code are:
    1. 1.  Certification by an ACCREDITED PROGRAM as specified in 2-102-20.
    2. 2.  Complying with this Code by having no violations of critical items during the current inspection; or
    3. 3.  Correct responses to the inspector's questions regarding public health practices and principles applicable to the operation. The inspector should assess this item by asking open-ended questions that would evaluate the PIC's knowledge in each of the areas enumerated in ¶ 2-102.11(C). Questions can be asked during the initial interview, menu review, or throughout the inspection as appropriate. The Inspector should ask a sufficient number of questions to enable the inspector to make an informed decision concerning the PIC's knowledge of the Code requirements and public health principles as they apply to the operation. The dialogue should be extensive enough to reveal whether or not that person is enabled by a clear understanding of the Code and its public health principles to follow sound food safety practices and to produce foods that are safe, wholesome, unadulterated, and accurately represented.
  3. C. Duties of the PIC .  This item should be marked OUT of compliance when there is a pattern of non-compliance and obvious failure by the PIC to ensure employees are complying with the duties listed in § 2‑103.11.  Since marking this item out of compliance requires judgment, it is important that this item not be marked for an isolated incident, but rather for an overall evaluation of the PIC's ability to ensure compliance with the duties described in § 2-103.11.
N.A.
Do Not Mark this item N.A.
N.O.
Do Not Mark this item N.O.

Employee Health

2.  Management and food employee knowledge, responsibilities and reporting.

IN/OUT

This item should be marked IN or OUT of compliance. This item is marked IN compliance when the following criteria are met:

  1. The PIC is aware of his or her responsibility to inform food employees and conditional employees of their responsibility to report certain symptoms or diagnosed diseases to the person in charge and for the PIC to report to the regulatory authority as specified under Food Code ¶2-103.11(M) and ¶¶2-201.11 (A),(B), (C), and (E); and
  2. The PIC provides documentation or otherwise satisfactorily demonstrates during the inspection, that all food employees and conditional employees are informed of their responsibility to report to management information about their health and activities as it relates to diseases that are transmissible through food, as specified under ¶2-201.11(A). Satisfactory compliance may be documented by completion of Form 1-B, Conditional Employees or Food Employees Reporting Agreement, in Annex 7 of the 2005 Food Code for each employee or other similar State or local form containing the same information; or
  3. In lieu of Form 1-B, compliance may be demonstrated by:
    1. a) Presenting evidence such as a curriculum and attendance rosters documenting that each employee has completed a training program which includes all the information required on Form 1-B regarding their reporting responsibilities; or
    2. b) Implementation of an employee health policy which includes a system of employee notification using a combination of training, signs, pocket cards, or other means to convey all of the required information on Form 1-B to all food employees and conditional employees. A signed acknowledgement by the employee should be part of any employee health policy.

The Regulatory Authority is encouraged to establish a policy of selecting one employee at random during each inspection and requesting the PIC verify, by one of the previously listed methods, that the selected employee has been informed of his or her responsibility to report symptoms, exposures, and diagnosed illnesses to management. The PIC is not expected to quote symptoms and diseases from memory, but should be able to locate that information on Form 1-B or similar documents used to demonstrate compliance.

N.A.
Do Not Mark this item N.A.
N.O.
Do Not Mark this item N.O.
3. Proper use of restriction and exclusion
IN/OUT

This item must be marked IN or OUT of compliance. To be marked IN there must be no ill employees, employees experiencing symptoms requiring reporting, or reason for the PIC to exclude or restrict an employee observed at the time of the inspection. Compliance must be based on first hand observations or information and cannot be based solely on responses from the PIC to questions regarding hypothetical situations or knowledge of the Food Code. This item should be marked OUT of compliance when:

  • The inspector observes a working employee with specific reportable symptoms (subparagraph 2-201.11 (A)(1); or
  • The inspector becomes aware that an employee has reported information about his or her health and activities as it relates to diseases that are transmissible through food and the PIC has not acted to restrict or exclude an employee as required by the Food Code (§2-201.12) & (§2-201.13); or
  • The inspector becomes aware that the PIC has not notified the regulatory authority that an employee is jaundiced or diagnosed with an illness due to a pathogen as specified under subparagraphs 2-201.11 (A)(2)(a)-(e) of the Food Code.
  • There are food employees working in the food establishment that have been diagnosed with Norovirus, hepatitis A virus, shigellosis, E.coli O157:H7, or other EHEC, or typhoid fever; or with active symptoms of vomiting and/or diarrhea; or working with food, food-contact equipment, utensils, or single-service articles with an open, uncovered infected wound or pustule, or with a sore throat with a fever. Additionally, in food establishments exclusively serving a highly susceptible population, there are to be no food employees with an active sore throat with a fever working in the food establishment,
N.A.
Do Not Mark this item N.A.
N.O.
Do Not Mark this item N.O.

Good Hygienic Practices

4. Proper eating, tasting, drinking, or tobacco use

IN/OUT
This item should be marked IN or OUT of compliance.
N.A.
Do Not Mark this item N.A.
N.O.
This item may be marked N.O. for retail operations only in the RARE case when there are no food workers present at the time of inspection.
5. No discharge from eyes, nose, and mouth
IN/OUT
This item should be marked IN or OUT of compliance.
N.A.
Do Not Mark this item N.A.
N.O.
This item may be marked N.O. for retail operations only in the RARE case when there are no food workers present at the time of inspection.

Preventing Contamination by Hands

6. Hands clean and properly washed

IN/OUT
This item should be marked IN or OUT of compliance. This item is marked IN compliance only when employees are observed using proper handwashing techniques at appropriate times and places.
N.A.
Do Not Mark this item N.A.
N.O.
This item may be marked N.O. for retail operations only in the RARE case when there are no food workers present at the time of inspection. (If there are no food workers present, but the PIC accompanies the inspector on the inspection and touches food, clean equipment, or utensils without washing his/her hands, this item is marked OUT.)
7. No bare hand contact with ready-to-eat foods or approved alternate method followed
IN/OUT

This item should be marked IN or OUT of compliance. This item is marked IN compliance only when employees are observed using suitable utensils or gloves to prevent bare hand (or arm) contact with ready-to-eat foods or are observed properly following a pre-approved alternative procedure to no bare hand contact.

A pre-approved alternative procedure to no bare hand contact is to include:

  1. 1. Prior approval from regulatory authority;
  2. 2. Written procedures maintained for: a. RTE foods to be contacted with bare hands; and b. diagrams regarding handwashing sinks;
  3. 3. Written employee health policy as specified in ¶3-301.11 (D);
  4. 4. Documentation that food employees acknowledge that they have received training
  5. 5. Documentation of proper handwashing:
  6. 6. Documentation that two or more control measures are used, and
  7. 7. Documentation of corrective actions taken when one or more of items 1-6 above are not followed.
N.A.
This item may be marked N.A. for establishments that provide only packaged, or bulk food items that are not ready-to-eat.
N.O.
This item may be marked N.O. for establishments that prepare ready-to-eat foods only, but no food preparation is performed at the time of inspection.
8. Adequate handwashing sinks, properly supplied and accessible
IN/OUT
This item should be marked IN or OUT of compliance.
N.A.
Do Not Mark this item N.A.
N.O.
Do Not Mark this item N.O.

Approved Source

9. Food obtained from approved source

IN/OUT
This item should be marked IN or OUT of compliance.
N.A.
Do Not Mark this item N.A.
N.O.
Do Not Mark this item N.O.
10. Food received at proper temperature
IN/OUT
This item should be marked IN or OUT of compliance.
N.A.
This item may be marked N.A. for retail operations when the establishment receives only foods that are not PHF (TCS) food and that are not frozen.
N.O.
This item may be marked N.O. if food is not received during the inspection.
11. Food in good condition, safe and unadulterated
IN/OUT
This item should be marked IN or OUT of compliance.
N.A.
Do Not Mark this item N.A.
N.O.
Do Not Mark this item N.O.
12. Required records available: shellstock tags, parasite destruction
NOTE :
Fish that are sold with the intent that the consumer will cook it are not required to be frozen for parasite destruction.
IN/OUT
This item should be marked IN or OUT of compliance.
N.A.
This item may be marked N.A. when shellstock are not used in the establishment and the only fish sold as raw, raw-marinated or undercooked is the tuna species or aquacultured fish listed as exempted from freezing in the Food Code.
N.O.
This item may be marked N.O. when shellstock or raw, raw-marinated and undercooked fish are sold periodically in the establishment, but are not being sold at the time of inspection and prior compliance through tags, invoices, or purchase records cannot be verified.

Protection from Contamination

13. Food separated and protected

IN/OUT
This item should be marked IN or OUT of compliance.
N.A.
This item may be marked N.A. when there are no raw animal foods used in the facility and only prepackaged foods are sold.
N.O.
Do not mark this item N.O.
14. Food-contact surfaces: cleaned and sanitized
IN/OUT
This item should be marked IN or OUT of compliance.
N.A.
This item may be marked N.A. only when there is no requirement to clean equipment and utensils such as when only prepackaged foods are sold.
N.O.
Do Not Mark this item N.O.
15. Proper disposition of returned, previously served, reconditioned, and unsafe food
IN/OUT
This item should be marked IN or OUT of compliance. This item is marked OUT of compliance if food is found unsafe, adulterated, from an unapproved source, or ready-to-eat food is contaminated by employees and is not discarded or reconditioned according to an approved procedure, or if previously served unwrapped, unprotected food is observed being re-served.
N.A.
Do Not Mark this item N.A.
N.O.
Do Not Mark this item N.O.

Potentially Hazardous Food (PHF) (Time Temperature Control for Safety Food) (TCS Food)

16. Proper cooking time and temperatures

NOTE :
The cooking temperatures of foods must be measured to determine compliance or noncompliance. Do not rely upon discussions with managers or cooks to make a determination of compliance or noncompliance. The temperature of raw animal foods in each species cooked during the inspection should be taken. For instance, if the facility fries chicken, scrambles eggs, bakes fish, grills hamburgers, and slow-roasts prime rib during the inspection - the cook temperatures of all of the products should be measured and recorded. Temperatures, both IN compliance and OUT of compliance, should be recorded in the "Temperature Observations" section of the inspection report. If there is insufficient space for the number of temperatures taken, additional temperatures should be documented in the "Observations and Corrective Actions" section on the second page of the inspection report. If a food is cooked below the required temperature but the facility has an approved Consumer Advisory or an approved variance with HACCP plan for that food item, mark the item IN compliance, record the temperature and document the reason it is in compliance. The time of inspections should be varied so that cooking can be observed.
IN/OUT
This item should be marked IN or OUT of compliance. This item should be marked OUT of compliance if the items checked do not meet the temperature requirements for cooking and the employee doing the cooking attempts to serve the product without returning the product to the cooking process.
N.A.
This item may be marked N.A. when no raw animal foods are cooked in the establishment.
N.O.

This item may be marked N.O. when no raw animal foods are cooked during the time of inspection.

The cooking temperature / time requirements for each raw animal species are as follows:

  • Raw eggs broken on request and prepared for immediate service cooked to 63°C (145°F) for 15 seconds; Raw eggs broken, but not prepared for immediate service, cooked to 68°C (155°F) for 15 seconds
  • Comminuted fish, meat, game animals cooked to 68°C (155°F) for 15 seconds
  • Roasts, including formed roasts, are cooked to 54.4°C (130°F) for 112 minutes or as chart specified and according to oven parameters per chart
  • Ratites and injected meats cooked to 68°C (155°F) for 15 seconds
  • Poultry, stuffed fish/meat/pasta/poultry/ratites, or stuffing containing fish, meat, poultry or ratites cooked to 74°C (165°F) for 15 seconds
  • Wild game animals cooked to 74°C (165°F) for 15 seconds
  • Whole-muscle, intact beef steaks cooked to surface temperature of 63°C (145°F) on top and bottom; meat surfaces have a cooked color change
  • Raw animal foods rotated, stirred, covered, and heated to 74°C (165°F) in microwave; food stands covered for 2 minutes after cooking
  • All other raw animal foods cooked to 63°C (145°F) for 15 seconds
17. Proper reheating procedures for hot holding
NOTE :
The reheating temperatures of foods must be taken to determine compliance or noncompliance. Do not rely solely upon discussions with managers or cooks to determine compliance or noncompliance. Temperatures IN and OUT of compliance should be recorded in the "Temperature Observations" section of the inspection report. If there is insufficient space for the number of temperatures taken, additional temperatures should be documented in the "Observations and Corrective Actions" section of the inspection report. This item should be marked OUT of compliance if the items checked are not reheated to the required temperatures.
IN/OUT
This item should be marked IN or OUT of compliance.
N.A.
This item may be marked N.A. when foods are not held over for a second service and/or reheating for hot holding is not performed in the establishment.
N.O.

This item may be marked N.O. such as when foods are held over for a second service, but no foods are reheated during the time of inspection.

The reheating for hot holding temperature / time requirements are as follows:

  • PHF (TCS) rapidly reheated to 74°C (165°F) for 15 seconds within 2 hours
  • Food reheated in a microwave to 74°C (165°F) or higher
  • Commercially processed ready-to-eat PHF (TCS) reheated to 57°C (135°F) or above within 2 hours
  • Remaining unsliced portions of roasts reheated for hot holding using minimum oven parameters
18. Proper cooling time and temperatures
NOTE:
The requirement for cooling cooked PHF (TCS) food, is that the food must be cooled from 135°F to 41°F or less (or to 45°F or less based on the jurisdictions cold holding temperature requirement), in 6 hrs provided that the food is cooled from 135°F to 70°F within the first 2 hours. For example, if a facility cools chili from 135°F to 70°F in 1.5 hours; they then have 4.5 hours to get it from 70°F to 41°For less (or 45°F or less). There are two critical limits that must be met with cooling. If the food is not cooled from 135°F to 70°F within 2 hours, this item is marked OUT. If the food is not cooled from 70°F to 41°F or less (or 45°F or less) within 6 hours minus the time it took the food to cool from 135°F to 70°F, the item is marked OUT. Discussions with the person in charge along with observations should be used to determine compliance. For instance, during discussion the person in charge says that a food product was cooled overnight in the walk-in cooler. The product is checked and the temperature is 50°F. Eight hours have elapsed from closing to opening. This item should be marked out because the product did not cool from 135°F to 70°F within two hours and from 70°F to 41°F or less (or 45°F or less) within 6 hours. Temperatures IN compliance and OUT of compliance should be recorded in the "Temperature Observations" section of the inspection report. If there is insufficient space for the number of temperatures taken, additional temperatures should be documented in the "Observations and Corrective Actions" section of the inspection report.
IN/OUT
This item should be marked IN or OUT of compliance.
N.A.
This item may be marked N.A. when the establishment does  not receive raw eggs, shellstock, or milk, prepares  no PHF (TCS) food from ambient temperature ingredients that require cooling, and does  not cool cooked PHF (TCS) food.
N.O.

This item may be marked N.O. when the establishment does cool PHF (TCS) food, but proper cooling per the prescribed temperature and time parameters cannot be determined during the length of the inspection.

The cooling categories and their temperature / time requirements are as follows:

  • Cooked PHF (TCS) food cooled from 57°C (135°F) to 5°C (41°F) or less, or to 7°C (45°F) or less in 6 hrs, provided that the food is cooled from 57°C (135°F) to 21°C (70°F) within the first 2 hours
  • PHF (TCS) food from ambient temperature ingredients cooled to 7°C/5°C (45°F/41°F) or below within 4 hours
  • Foods (shellstock, milk) received at a temperature according to law cooled to 7°C/5°C (45°F/ 41°F) within 4 hours
  • Raw eggs received at an ambient temperature of 7°C (45°F) immediately placed in refrigerated equipment that maintains an ambient air temperature of 7°C (45°F)
19. Proper hot holding temperatures
NOTE:
Temperatures IN compliance and OUT of compliance should be recorded in the "Temperature Observations" section of the inspection report. If there is insufficient space for the number of temperatures taken, additional temperatures should be documented in the "Observations and Corrective Action" section of the inspection report.
IN/OUT
This item should be marked IN or OUT of compliance.
N.A.
This item may be marked N.A. when the establishment does not hot hold food.
N.O.
This item may be marked N.O. when the establishment does hot hold foods, but no foods are being held hot during the time of inspection.
20. Proper cold holding temperatures
NOTE:
Temperatures IN compliance and OUT of compliance should be recorded in the "Temperature Observations" section of the inspection report. If there is insufficient space for the number of temperatures taken, additional temperatures should be documented in the "Observations and Corrective Action" section of the inspection report.
IN/OUT
This item should be marked IN or OUT of compliance.
N.A.
This item may be marked N.A. when the establishment does  not cold hold food.
N.O.
Do not mark this item N.O.
21. Proper date marking and disposition
IN/OUT
This item should be marked IN or OUT of compliance. For disposition, mark IN when foods are all within date marked time limits or food is observed being discarded within date marked time limits or OUT of compliance, such as when date marked food exceeds the time limit or date-marking is not done,
N.A.
This item may be marked N.A. when there is no ready-to-eat, PHF (TCS) food prepared and held, or commercial containers of ready-to-eat, PHF (TCS) food opened and held, over 24 hours in the establishment.
N.O.
This item may be marked N.O. when the establishment does handle foods requiring date marking, but there are no foods requiring date marking in the facility at the time of inspection. For disposition, mark N.O. when RTE, PHF (TCS) food is prepared-on-premises, or opened commercial container is held beyond the 7-day or 4-day time limits and you are unable to determine compliance.
22. Time as a Public Health Control: procedures and records
IN/OUT
This item should be marked IN or OUT of compliance.
N.A.
This item may be marked N.A. when the establishment does not use time only as the public health control.
N.O.
This item may be marked N.O. when the establishment uses time only as the public health control, but is not using this practice at the time of inspection.

Consumer Advisory

23. Consumer advisory provided for raw or undercooked food

IN/OUT
This item should be marked IN or OUT of compliance. This item is marked IN compliance if the establishment provides an advisory that meets disclosure and reminder.
N.A.
This item may be marked N.A. when the establishment does not serve raw or undercooked animal foods.
N.O.
Do Not Mark this item N.O.

Highly Susceptible Population

24.  Pasteurized foods used; prohibited foods  not offered

NOTE:
Discussions with the person in charge and employees regarding whether or not certain foods are served or certain practices occur in the establishment, along with observations should be used to determine compliance
IN/OUT
This item should be marked IN or OUT of compliance.
N.A
This item may be marked N.A. if a highly susceptible population is not served.
N.O.
Do Not Mark this item N.O. 

Food/Color Additives and Toxic Substances

25. Food additives: approved and properly used

IN/OUT
This item should be marked IN or OUT of compliance. This item is marked IN compliance if approved food and color additives are on site and used properly or if sulfites are on the premises, and they are not applied to fresh fruits/vegetables for raw consumption. This item is marked OUT of compliance if unapproved additives are found on the premises or approved additives are improperly used, such as sulfites being applied to fresh fruits or vegetables.
N.A.
This item may be marked N.A. if the food establishment does  not use any additives or sulfites on the premises.
N.O.
Do Not Mark this item N.O.
26. Toxic substances properly identified, stored, and used
IN/OUT
This item should be marked IN or OUT of compliance.
N.A.
Do Not Mark this item N.A.
N.O.
Do Not Mark this item N.O.

Conformance with Approved Procedures

27. Compliance with variance, specialized process, reduced oxygen packaging criteria or HACCP plan

IN/OUT
This item should be marked IN or OUT of compliance.
N.A.
This item may be marked N.A. if the establishment is not required by the regulatory authority to have a variance or HACCP plan, juice is not packaged or reduced oxygen packaging is not done on the premises.
N.O.
Do Not Mark this item N.O.
D. Marking Instructions for each GOOD RETAIL PRACTICE (GRP) ON the Inspection Report

Good Retail Practices ( GRPs ) are preventive measures that include practices and procedures which effectively control the introduction of pathogens, chemicals, and physical objects into food. If GRPs are not controlled, they could be contributing factors to foodborne illness. However, the intention of this inspection form is to focus the inspector's attention on those factors that have been shown to be most often linked with causing foodborne illness. Since the major emphasis of an inspection should be on the Risk Factors that cause foodborne illness and the Public Health interventions that have the greatest impact on preventing foodborne illness, the GRPs have been given less importance on the inspection form and a differentiation between IN, OUT, N.A. and N.O. is not made in this area. For marking the GRPs section, place an "X" in the box to the left of the numbered item if a code provision under that item is  OUT of compliance. Document each violation of the code provision for the item number in the "Observations and Corrective Actions" section on the second page of the inspection report. For items marked out of compliance, further indicate the VIOLATION STATUS by marking an "X" in the corresponding box : COS = Corrected on site during inspection and R = Repeat violation per the same instructions as given in the Risk Factor section. References to the appropriate Food Code provisions that can be debited under each numbered GRP item are listed in Guide 3-B.

E. TEMPERATURE OBSERVATIONS
Item/location
Record the common name of the food as well as the condition, process, and location of the food at the time of monitoring e.g. hot holding, refrigerator, prep-table. Temperatures in compliance and out of compliance should be documented. If there is insufficient space for the number of temperatures taken, record the additional temperatures in the "Observations and Corrective Actions" section of the inspection report.
Food Temperature
Record the temperature indicated on the inspector's thermometer. Specify the measurement in °F or °C. (Note: Food temperature measuring devices that are scaled only in Fahrenheit should be accurate to ±2°F in the intended range of use. Food temperature measuring devices that are scaled only in Celsius or dually scaled in Celsius and Fahrenheit should be accurate to ± 1°C in the intended range of use.)
F. OBSERVATIONS AND CORRECTIVE ACTIONS

Include here specific descriptions of violations observed and recorded in the Risk Factors and Interventions section and Good Retail Practices check boxes. Also include corrective actions for the noted violations and temperatures if there is insufficient space in the allotted section for temperature recordings.

G. SIGNATURE BLOCK
Person in Charge
The PIC is the individual present at a food establishment who is responsible for the operation at the time of the inspection.
Inspector
The Inspector is the individual conducting the inspection.
Date
The date the inspection is completed.
Follow-up
The determination of whether to conduct a reinspection or other enforcement action.
Follow-up Date
The date the follow-up inspection will be conducted.

 

Part 3. New Terms added to the Index to the Food Code

Dealer

 


1 In order to comply with Title I of the Americans with Disabilities Act, an exclusion must also be removed if the employee is entitled to a reasonable accommodation that would eliminate the risk of transmitting the disease. Reasonable accommodation may include reassignment to another position in which the individual would not work around food. The steps an employer must take when an excluded employee requests reasonable accommodation are briefly described in Annex 3, § 2-201.11. However, it is not possible to explain all relevant aspects of the ADA within this Annex. When faced with an apparent conflict between the ADA and the Food Code's exclusion and restriction requirements, employers should contact the U.S. Equal Employment Opportunity Commission.