3-202.11 Temperature.*

[text of changed paragraph]

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.

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.

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.

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:

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

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.

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.

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.

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).

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.

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.

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.

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.

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.

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.

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).

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.

 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".

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, a_w, pH and a_w 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 a_w 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 a_w value is low enough by itself to control or eliminate pathogen growth; however, the interaction of pH and a_w 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 a_w 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 a_w 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, a_w > 0.99, not heat-treated), fresh sprouts (pH > 6.5, a_w > 0.99, not heat-treated), and cut tomatoes (pH 4.23 - 5.04, a_w > 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 a_w 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.

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.

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?

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.

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

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.

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.

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.

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.

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

Figure 2. Product temperatures after transport 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.

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

When the food to be packaged under reduced oxygen conditions cannot reliably depend on secondary barriers such as a_w, 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.

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.

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.

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)
      YES 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)
      YES 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)

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

Page____of____

Food Establishment Inspection Report

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

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

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 

Employee Health

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

Good Hygienic Practices

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

Preventing Contamination by Hands

6. Hands clean and properly washed

Approved Source

9. Food obtained from approved source

Protection from Contamination

13. Food separated and protected

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

16. Proper cooking time and temperatures

Consumer Advisory

23. Consumer advisory provided for raw or undercooked food

Highly Susceptible Population

24.  Pasteurized foods used; prohibited foods  not offered

Food/Color Additives and Toxic Substances

25. Food additives: approved and properly used

Conformance with Approved Procedures

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

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.