3−4 | DESTRUCTION OF ORGANISMS OF PUBLIC HEALTH CONCERN Subparts 3−401 Cooking 3−402 Freezing 3−403 Reheating 3−404 Other Methods |
Cooking | 3−401.11 | Raw Animal Foods. |
Minimum Temperature C (F) | Minimum Time |
63 (145) | 3 minutes |
66 (150) | 1 minute |
70 (158) | <1 second (instantaneous) |
Oven Type | Oven Temperature Based on Roast Weight |
Less than 4.5 kg (10 lbs) | 4.5 kg (10 lbs) or More |
Still Dry | 177°C (350°F) or more | 121°C (250°F) or more |
Convection | 163°C (325°F) or more | 121°C (250°F) or more |
High Humidity1 | 121°C (250°F) or less | 121°C (250°F) or less |
1Relative humidity greater than 90% for at least 1 hour as measured in the cooking chamber or exit of the oven; or in a moisture−impermeable bag that provides 100% humidity. |
; and (2) As specified in the following chart, to heat all parts of the FOOD to a temperature and for the holding time that corresponds to that temperature: P
1Holding time may include postoven heat rise. A raw or undercooked WHOLE−MUSCLE, INTACT BEEF steak may be served or offered for sale in a READY−TO−EAT form if: The FOOD ESTABLISHMENT serves a population that is not a HIGHLY SUSCEPTIBLE POPULATION, The steak is labeled to indicate that it meets the definition of “WHOLE−MUSCLE, INTACT BEEF” as specified under ¶ 3−201.11 (E), and The steak is cooked on both the top and bottom to a surface temperature of 63°C (145°F) or above and a cooked color change is achieved on all external surfaces. A raw animal FOOD such as raw EGG, raw FISH, raw−marinated FISH, raw MOLLUSCAN SHELLFISH, or steak tartare; or a partially cooked FOOD such as lightly cooked FISH, soft cooked EGGS, or rare MEAT other than WHOLE−MUSCLE, INTACT BEEF steaks as specified in ¶ (C) of this section, may be served or offered for sale upon CONSUMER request or selection in a READY−TO−EAT form if: |
As specified under¶¶ 3−801.11 (C)(1) and (2), the FOOD ESTABLISHMENT serves a population that is not a HIGHLY SUSCEPTIBLE POPULATION; The FOOD, if served or offered for service by CONSUMER selection from a children’s menu, does not contain COMMINUTED MEAT; Pf and The CONSUMER is informed as specified under § 3−603.11 that to ensure its safety, the FOOD should be cooked as specified under ¶ (A) or (B); or The DEPARTMENT grants a VARIANCE from ¶ (A) or (B) of this section as specified in § 1−105.11 based on a HACCP PLAN that: Is submitted by the LICENSE HOLDER and APPROVED as specified under § 1−106.13, Documents scientific data or other information showing that a lesser time and temperature regimen results in a safe FOOD, and Verifies that EQUIPMENT and procedures for FOOD preparation and training of FOOD EMPLOYEES at the FOOD ESTABLISHMENT meet the conditions of the VARIANCE. 3−401.12 Microwave Cooking. Raw animal FOODS cooked in a microwave oven shall be: Rotated or stirred throughout or midway during cooking to compensate for uneven distribution of heat; Covered to retain surface moisture; Heated to a temperature of at least 74°C (165°F) in all parts of the FOOD; and Allowed to stand covered for 2 minutes after cooking to obtain temperature equilibrium. 3−401.13 Plant Food Cooking for Hot Holding. Plant foods such as fruits, and vegetables, roots and grains that are cooked for hot holding shall be cooked to a temperature of 57°C (135°F). Pf 3−401.14 Non−Continuous Cooking of Raw Animal Foods. Raw animal FOODS that are cooked using a NON−CONTINUOUS cooking process shall be: |
Subject to an initial heating process that is no longer than sixty minutes in duration; P Immediately after initial heating, cooled according to the time and temperature parameters specified for cooked TIME/TEMPERATURE CONTROL SAFETY FOOD under ¶ 3−501.14 (A); P After cooling, held frozen or cold, as specified for TIME/TEMPERATURE CONTROL SAFETY FOOD under ¶ 3−501.16 (A) (2); P Prior to sale or service, cooked using a process that heats all parts of the FOOD to a temperature and for a time as specified under ¶¶ 3-401.11 (A) – (C); P Cooled according to the time and temperature parameters specified for cooked TIME/TEMPERATURE CONTROL SAFETY FOOD under ¶ 3−501.14 (A) if not either hot held as specified under ¶ 3−501.16 (A), served immediately, or held using time as a public health control as specified under § 3−501.19 after complete cooking; P and Prepared and stored according to written procedures that: Have obtained prior APPROVAL from the REGULATORY AUTHORITY; Pf Are maintained in the FOOD ESTABLISHMENT and are available to the REGULATORY AUTHORITY upon request; Pf Describe how the requirements specified under ¶ (A) - (E) of this section are to be monitored and documented by the LICENSE HOLDER and the corrective actions to be taken if the requirements are not met; Pf |
Describe how the FOODS, after initial heating, but prior to complete cooking, are to be marked or otherwise identified as FOODS that must be cooked as specified under ¶ (D) of this section prior to being offered for sale or service; Pf and Describe how the FOODS, after initial heating but prior to cooking as specified under ¶ (D) of this section, are to be separated from READY−TO−EAT FOODS as specified under ¶ 3−302.11. Pf |
Freezing | 3−402.11 Parasite Destruction. (A) Except as specified in ¶ (B) of this section, before service or sale in READY−TO−EAT form, raw, raw−marinated, partially cooked, or marinated−partially cooked FISH shall be: Frozen and stored at a temperature of −20°C (−4°F) or below for a minimum of 168 hours (7 days) in a freezer; P Frozen at −35°C (−31°F) or below until solid and stored at −35°C (−31°F) or below for a minimum of 15 hours; P or Frozen at −35°C (−31°F) or below until solid and stored at −20°C (−4°F) or below for a minimum of 24 hours. P (B) Paragraph (A) of this section does not apply to: MOLLUSCAN SHELLFISH; A scalloped product consisting only of the shucked adductor muscle; Tuna of the species Thunnus alalunga, Thunnus albacores (Yellowfin tuna), Thunnus atlanticus, Thunnus maccoyii (Bluefin tuna, Southern), Thunnus obesus (Bigeye tuna), or Thunnus thynnus (Bluefin tuna, Northern); or Aquacultured fish, such as salmon, that: If raised in open water, are raised in net−pens, or Are raised in land−based operations such as ponds or tanks, and Are fed formulated feed, such as pellets, that contains no live parasites infective to the aquacultured fish. FISH eggs that have been removed from the skein and rinsed. |
3−402.12 Records, Creation and Retention. Except as specified in ¶ 3−402.11 (B) and ¶ (B) of this section, if raw, raw−marinated, partially cooked, or marinated−partially cooked FISH are served or sold in READY−TO−EAT form, the PERSON IN CHARGE shall record the freezing temperature and time to which the FISH are subjected and shall retain the records at the FOOD ESTABLISHMENT for 90 calendar days beyond the time of service or sale of the FISH. Pf If the FISH are frozen by a supplier, a written agreement or statement from the supplier stipulating that the FISH supplied are frozen to a temperature and for a time specified under § 3−402.11 may substitute for the records specified under ¶ (A) of this section. If raw, raw−marinated, partially cooked, or marinated−partially cooked FISH are served or sold in READY−TO−EAT form, and the FISH are raised and fed as specified in Subparagraph 3−402.11 (B)(4), a written agreement or statement from the supplier or aquaculturist stipulating that the FISH were raised and fed as specified in Subparagraph 3−402.11 (B)(4) shall be obtained by the PERSON IN |
CHARGE and retained in the records of the FOOD ESTABLISHMENT for 90 calendar days beyond the time of service or sale of the FISH. Pf 3−403.10 Preparation for Immediate Service. Cooked and refrigerated FOOD that is prepared for immediate service in response to an individual CONSUMER order, such as a roast beef sandwich au jus, may be served at any temperature. |
Reheating | 3−403.11 Reheating for Hot Holding. Except as specified under ¶¶ (B), (C), and (E) of this section, 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. P Except as specified under ¶ (C) of this section, 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. P READY−TO−EAT TIME/TEMPERATURE CONTROL FOR SAFETY FOOD that has been commercially PROCESSED and PACKAGED in a FOOD PROCESSING PLANT that is inspected by the REGULATORY AUTHORITY that has jurisdiction over the plant, shall be heated to a temperature of at least 57°C (135°F) when being reheated for hot holding. P |
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. P Remaining unsliced portions of MEAT roasts that are cooked as specified under ¶ 3−401.11 (B) may be reheated for hot holding using the oven parameters and minimum time and temperature conditions specified under ¶ 3−401.11 (B). |
Other Methods | 3−404.11 Treating Juice. JUICE PACKAGED in a FOOD ESTABLISHMENT shall be: Treated under a HACCP PLAN as specified by the DEPARTMENT in § 1-105.12, to attain a 5−log reduction, which is equal to a 99.999% reduction, of the most resistant microorganism of public health significance; P or Labeled, if not treated to yield a 5−log reduction of the most resistant microorganism of public health significance: Pf (1) As specified under § 3−602.11, Pf and |
(2) As specified in 21 CFR 101.17 (g) Food labeling, warning, notice, and safe handling statements, JUICES that have not been specifically processed to prevent, reduce, or eliminate the presence of pathogens with the following, “WARNING: This product has not been pasteurized and, therefore, may contain harmful bacteria that can cause serious illness in children, the elderly, and persons with weakened immune systems.” Pf Note: For prepackaged JUICE see 3−202.110. |
3−5 | LIMITATION OF GROWTH OF ORGANISMS OF PUBLIC HEALTH CONCERN Subparts 3−501 Temperature and Time Control 3−502 Specialized Processing Methods |
Temperature and Time Control | 3−501.11 Frozen Food. Stored frozen FOODS shall be maintained frozen. 3−501.12 TIME/TEMPERATURE CONTROL FOR SAFETY FOOD, Slacking. Frozen TIME/TEMPERATURE CONTROL FOR SAFETY FOOD that is SLACKED to moderate the temperature shall be held: Under refrigeration that maintains the FOOD temperature at 5°C (41°F) or less; or At any temperature if the FOOD remains frozen. |
3−501.13 Thawing. Except as specified in ¶ (D) of this section, TIME/TEMPERATURE CONTROL FOR SAFETY FOOD shall be thawed: Under refrigeration that maintains the FOOD temperature at 5°C (41°F) or less; Pf or Completely submerged under running water: At a water temperature of 21°C (70°F) or below, Pf With sufficient water velocity to agitate and float off loose particles in an overflow, Pf and For a period of time that does not allow thawed portions of READY−TO−EAT FOOD to rise above 5°C (41°F), Pf or |
(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: The time the FOOD is exposed to the running water and the time needed for preparation for cooking, Pf or The time it takes under refrigeration to lower the FOOD temperature to 5°C (41°F); Pf As part of a cooking process if the FOOD that is frozen is: Cooked as specified under ¶ 3−401.11 (A) or (B) or § 3−401.12, Pf or Thawed in a microwave oven and immediately transferred to conventional cooking EQUIPMENT, with no interruption in the process; Pf or Using any procedure if a portion of frozen READY−TO−EAT FOOD is thawed and prepared for immediate service in response to an individual CONSUMER’S order. REDUCED OXYGEN PACKAGED FISH that bears a label indicating that it is to be kept frozen until time of use shall be removed from the reduced oxygen environment: Prior to its thawing under refrigeration as specified in ¶ (A) of this section; or Prior to, or immediately upon completion of, its thawing using procedures specified in ¶ (B) of this section. |
3−501.14 Cooling. Cooked TIME/TEMPERATURE CONTROL FOR SAFETY FOOD shall be cooled: Within 2 hours from 57°C (135°F) to 21°C (70°F); P and Within a total of 6 hours from 57°C (135°F) to 5°C (41°F) or less. P 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. P Cheese curds received as specified in ¶ 3−202.11 (G), which are intended to be sold at temperatures of 5°C (41°F) or less. P Except as specified in ¶ (D) of this section, a 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) and (G), shall be cooled within 4 hours to 5°C (41°F) or less. P |
(D) Raw EGGS shall be received as specified under ¶ 3−202.11 (C) and immediately placed in refrigerated EQUIPMENT that maintains an ambient air temperature of 5°C (41°F) or less. P 3−501.15 Cooling Methods. Cooling shall be accomplished in accordance with the time and temperature criteria specified under § 3−501.14 by using one or more of the following methods based on the type of FOOD being cooled: Placing the FOOD in shallow pans; Pf |
Separating the FOOD into smaller or thinner portions; Pf Using rapid cooling EQUIPMENT; Pf Stirring the FOOD in a container placed in an ice water bath; Pf |
Using containers that facilitate heat transfer; Pf Adding ice as an ingredient; Pf or Other effective methods. Pf |
When placed in cooling or cold holding EQUIPMENT, FOOD containers in which FOOD is being cooled shall be: Arranged in the EQUIPMENT to provide maximum heat transfer through the container walls; and Loosely covered, or uncovered if protected from overhead contamination as specified under Subparagraph 3−305.11 (A) (2), during the cooling period to facilitate heat transfer from the surface of the FOOD. 3−501.16 Time/Temperature Control for Safety Food, Hot and Cold Holding. (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) - (D) of this section, TIME/TEMPERATURE CONTROL FOR SAFETY FOOD shall be maintained: (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; P or |
(2) At 5°C (41°F) or less. P EGGS that have not been treated to destroy all viable Salmonellae shall be stored in refrigerated EQUIPMENT that maintains an ambient air temperature of 5°C (41°F) or less. P 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). |
on−premises preparation • prepare and hold cold | 3−501.17 Ready−to−Eat, Time/Temperature Control for Safety Food, Date Marking. (A) Except when PACKAGING FOOD using a REDUCED OXYGEN PACKAGING method as specified under § 3−502.12, and except as specified in ¶¶ (E), (F), and (H) of this section, refrigerated, READY−TO−EAT, 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 and time combination of 5°C (41°F) or less for a maximum of 7 days. The day of preparation shall be counted as Day 1. Pf |
commercially processed food • open and hold cold | Except as specified in ¶¶ (E) - (H) of this section, refrigerated, READY−TO−EAT, TIME/TEMPERATURE CONTROL FOR SAFETY FOOD prepared and PACKAGED by a FOOD PROCESSING PLANT shall be clearly marked at the time the original container is opened in a FOOD ESTABLISHMENT and, if the FOOD is held for more than 24 hours, to indicate the date or day by which the FOOD shall be consumed on the PREMISES, sold, or discarded, based on the temperature and time combinations specified in ¶ (A) of this section and; Pf The day the original container is opened in the FOOD ESTABLISHMENT shall be counted as Day 1; Pf and The day or date marked by the FOOD ESTABLISHMENT may not exceed a manufacturer’s use−by date if the manufacturer determined the use−by date based on FOOD safety. Pf A refrigerated, READY−TO−EAT, TIME/TEMPERATURE CONTROL FOR SAFETY FOOD ingredient or a portion of a refrigerated, READY−TO−EAT, TIME/TEMPERATURE CONTROL FOR SAFETY FOOD that is subsequently combined with additional ingredients or portions of FOOD shall retain the date marking of the earliest−prepared or first−prepared ingredient. Pf A date marking system that meets the criteria stated in ¶¶ (A) and (B) of this section may include: Using a method APPROVED by the REGULATORY AUTHORITY for refrigerated, READY−TO−EAT, TIME/TEMPERATURE CONTROL FOR SAFETY FOOD that is frequently rewrapped, such as lunchmeat or a roast, or for which date marking is impractical, such as soft serve mix or milk in a dispensing machine; |
Marking the date or day of preparation, with a procedure to discard the FOOD on or before the last date or day by which the FOOD must be consumed on the premises, sold, or discarded as specified under ¶ (A) of this section; Marking the date or day the original container is opened in a FOOD ESTABLISHMENT, with a procedure to discard the FOOD on or before the last date or day by which the FOOD must be consumed on the premises, sold, or discarded as specified under ¶ (B) of this section; or Using calendar dates, days of the week, color−coded marks, or other effective marking methods, provided that the marking system is disclosed to the REGULATORY AUTHORITY upon request. |
Paragraphs (A) and (B) of this section do not apply to individual meal portions served or rePACKAGED for sale from a bulk container upon a CONSUMER’S request. Paragraphs (A) and (B) of this section do not apply to SHELLSTOCK. Paragraph (B) of this section does not apply to the following FOODS prepared and PACKAGED by a FOOD PROCESSING PLANT inspected by a REGULATORY AUTHORITY: Deli salads, such as ham salad, seafood salad, chicken salad, EGG salad, pasta salad, potato salad, and macaroni salad, manufactured in accordance with 21 CFR 117 - Current Good Manufacturing Practice, Hazard Analysis, And Risk-Based Preventive Controls For Human Food; Hard cheeses containing not more than 39% moisture as defined in 21 CFR 133 - Cheeses and related cheese products, such as cheddar, gruyere, parmesan and reggiano, and romano; Semi−soft cheeses containing more than 39% moisture, but not more than 50% moisture, as defined in 21 CFR 133 Cheeses and related cheese products, such as blue, edam, gorgonzola, gouda, and monterey jack; Cultured dairy products as defined in 21 CFR 131 Milk and cream, such as yogurt, sour cream, and buttermilk; Preserved FISH products, such as pickled herring and dried or salted cod, and other acidified FISH products defined in 21 CFR 114 Acidified foods; Shelf stable, dry fermented sausages, such as pepperoni and Genoa ; and Shelf stable salt−cured products such as prosciutto and Parma (ham). |
(H) Paragraphs (A) and (B) of this section do not apply to cheese curds held under ¶ 3-501.19 (D). |
3−501.18 Ready−to−Eat, Time/Temperature Control for Safety Food, Disposition. A FOOD specified in ¶ 3−501.17 (A) or (B) shall be discarded if it: Exceeds the temperature and time combination specified in ¶ 3−501.17 (A), except time that the product is frozen; P Is in a container or PACKAGE that does not bear a date or day; P or Is appropriately marked with a date or day that exceeds a temperature and time combination as specified in ¶ 3−501.17 (A). P Refrigerated, READY−TO−EAT, TIME/TEMPERATURE CONTROL FOR SAFETY FOOD prepared in a FOOD ESTABLISHMENT and dispensed through a VENDING MACHINE with an automatic shutoff control shall be discarded if it exceeds a temperature and time combination as specified in ¶ 3−501.17 (A). P 3−501.19 Time as a Public Health Control. (A) Except as specified under ¶ (E) of this section, if time without temperature control is used as the public health control for a working supply of TIME/TEMPERATURE CONTROL FOR SAFETY FOOD before cooking, or for READY−TO−EAT TIME/TEMPERATURE CONTROL FOR SAFETY FOOD that is displayed or held for sale or service: (1) Written procedures shall be prepared in advance, maintained in the FOOD ESTABLISHMENT and made available to the REGULATORY AUTHORITY upon request that specify: Pf Methods of compliance with Subparagraphs (B)(1) - (4), (C)(1) - (5), or (D)(1) - (6) of this section; Pf and Methods of compliance with § 3−501.14 for FOOD that is prepared, cooked, and refrigerated before time is used as a public health control. Pf |
Time - maximum up to 4 hours | (B) If time without temperature control is used as the public health control up to a maximum of 4 hours: |
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; P 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; Pf 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; P and The FOOD in unmarked containers or PACKAGES, or marked to exceed a 4−hour limit shall be discarded. P |
Time - maximum up to 6 hours | (C) If time without temperature control is used as the public health control up to a maximum of 6 hours: 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; P 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; Pf The FOOD shall be marked or otherwise identified to indicate: Pf The time when the FOOD is removed from 5°C (41°F) or less cold holding temperature control, Pf and The time that is 6 hours past the point in time when the FOOD is removed from cold holding temperature control; Pf The FOOD shall be: Discarded if the temperature of the FOOD exceeds 21°C (70°F),P or 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; P and The FOOD in unmarked containers or PACKAGES, or marked with a time that exceeds the 6−hour limit shall be discarded. P |
Time — Cheese Curds intended for the production of Cheddar cheese | If time without temperature control used as the public health control to display cheese curds intended for the production of Cheddar cheese: The cheese curds shall not be held for more than 24 hours from the time of manufacturing; P The cheese curds must be manufactured according to LAW; P The cheese curds must be PACKAGED at a FOOD ESTABLISHMENT or FOOD PROCESSING PLANT; Pf The cheese curds must be labeled as specified in § 3−602.11 including the date or the date and time of manufacture; Pf and Note: Cheese curds marked only with the date of manufacture must be discarded by 12:00pm of that date if held at ambient temperature. Cheese curds marked with the date and time of manufacture may be held up to 24 hour from the date and time of manufacture prior to being discarded if held at ambient temperature. The establishment shall maintain records indicating the amount of product displayed and the amount of product discarded for each day that cheese curds are displayed at ambient temperature for sale. Pf Cheese curds in unmarked containers or PACKAGES that exceed the 24−hour limit, shall be discarded. P A FOOD ESTABLISHMENT that serves a HIGHLY SUSCEPTIBLE POPULATION may not use time as specified under ¶¶ (A) to (D) of this section as the public health control for raw EGGS and cheese curds intended for the production of Cheddar cheese. |
Specialized Processing Methods | 3−502.11 Variance Requirement. A FOOD ESTABLISHMENT shall obtain a VARIANCE from the DEPARTMENT as specified in § 1−104.11 and under § 1−105.12 before: Pf Smoking FOOD as a method of FOOD preservation rather than as a method of flavor enhancement; Pf Curing FOOD; Pf Using FOOD ADDITIVES or adding components such as vinegar: Pf As a method of FOOD preservation rather than as a method of flavor enhancement, Pf or To render a FOOD so that it is not TIME/TEMPERATURE CONTROL FOR SAFETY FOOD; Pf |
PACKAGING TIME/TEMPERATURE CONTROL FOR SAFETY FOOD using a REDUCED OXYGEN PACKAGING method except where the growth of and toxin formation by Clostridium botulinum and the growth of Listeria monocytogenes are controlled as specified under § 3−502.12 ; Pf Operating a MOLLUSCAN SHELLFISH life−support system display tank used to store or display shellfish that are offered for human consumption; Pf Custom processing animals that are for personal use as FOOD and not for sale or service in a FOOD ESTABLISHMENT; Pf Preparing FOOD by another method that is determined by the DEPARTMENT to require a VARIANCE; Pf or Sprouting seeds or beans. Pf The slaughter and evisceration of FISH, other than MOLLUSCAN SHELLFISH. Pf |
Clostridium botulinum and Listeria monocytogenes Controls | 3−502.12 Reduced Oxygen Packaging Without a Variance, Criteria. Except for a FOOD ESTABLISHMENT that obtains a VARIANCE as specified under § 3−502.11, a FOOD ESTABLISHMENT that PACKAGES TIME/TEMPERATURE CONTROL FOR SAFETY FOOD using a REDUCED OXYGEN PACKAGING method shall control the growth and toxin formation of Clostridium botulinum and the growth of Listeria monocytogenes. P Except as specified under ¶ (F) of this section, a FOOD ESTABLISHMENT that PACKAGES TIME/TEMPERATURE CONTROL FOR SAFETY FOOD using a REDUCED OXYGEN PACKAGING method shall implement a HACCP PLAN that contains the information specified by the DEPARTMENT under §§ 1-106.11 and 1-106.12 and that: Pf Identifies the FOOD to be PACKAGED; Pf Except as specified under ¶¶ (C) - (E) of this section, requires that the PACKAGED FOOD shall be maintained at 5°C (41°F) or less and meet at least one of the following criteria: Pf Has a Aw of 0.91 or less, Pf Has a pH of 4.6 or less, Pf Is a MEAT or POULTRY product cured at a FOOD PROCESSING PLANT regulated by the USDA or DEPARTMENT using substances specified in 9 CFR 424.21, Use of food ingredients and sources of radiation, and is received in an intact PACKAGE, Pf or Is a FOOD with a high level of competing organisms such as raw MEAT, raw POULTRY, or raw vegetables; Pf |
Describes how the PACKAGE shall be prominently and conspicuously labeled on the principal display panel in bold type on a contrasting background, with instructions to: Pf Maintain the FOOD at 5°C (41°F) or below, Pf and Discard the FOOD if within 30 calendar days of its PACKAGING if it is not served for on−PREMISES consumption, or consumed if served or sold for off−PREMISES consumption; Pf Limits the refrigerated shelf life to no more than 30 calendar days from PACKAGING to consumption, except the time the product is maintained frozen, or the original manufacturer’s “sell by” or “use by” date, whichever occurs first; P Includes operational procedures that: Prohibit contacting READY−TO−EAT FOOD with bare hands as specified under ¶ 3−301.11 (B), Pf Identify a designated work area and the method by which: Pf Physical barriers or methods of separation of raw FOODS and READY−TO− EAT FOODS minimize cross contamination, Pf and Access to the processing EQUIPMENT is limited to responsible trained personnel familiar with the potential HAZARDS of the operation, Pf and Delineate cleaning and SANITIZATION procedures for FOOD−CONTACT SURFACES; Pf and Describes the training program that ensures that the individual responsible for the REDUCED OXYGEN PACKAGING operation understands the: Pf Concepts required for a safe operation, Pf EQUIPMENT and facilities, Pf and Procedures specified under Subparagraph (B) (5) of this section and ¶ 1-106.12. Pf Is provided to the DEPARTMENT prior to implementation as specified under ¶¶ 1-106.11 and 1-106.13. |
Fish | (C) Except for FISH that is frozen before, during, and after PACKAGING, a FOOD ESTABLISHMENT may not PACKAGE FISH using a REDUCED OXYGEN PACKAGING method. P |
Cook−Chill or Sous Vide | (D) Except as specified under ¶ (C) and ¶ (F) of this section, a FOOD ESTABLISHMENT that PACKAGES TIME/TEMPERATURE CONTROL FOR SAFETY FOOD using a cook−chill or sous vide process shall: Provide to the DEPARTMENT prior to implementation, a HACCP PLAN that contains the information as specified by the DEPARTMENT under §§ 1-106.11 and 1-106.12; Pf Ensure the FOOD is: 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 PACKAGED product to another business entity or the CONSUMER, Pf Cooked to heat all parts of the FOOD to a temperature and for a time as specified under §§ 3−401.11 (A), (B), and (C), P Protected from contamination before and after cooking as specified under Parts 3−3 and 3−4, P Placed in a PACKAGE with an oxygen barrier and sealed before cooking, or placed in a PACKAGE and sealed immediately after cooking and before reaching a temperature below 57°C (135°F), P Cooled to 5°C (41°F) in the sealed PACKAGE or bag as specified under § 3−501.14 and: P 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 PACKAGING; P Held at 5°C (41°F) or less for no more than 7 days, at which time the FOOD must be consumed or discarded; P or Held frozen with no shelf life restriction while frozen until consumed or used. P Held in a refrigeration unit that is equipped with an electronic system that continuously monitors time and temperature and is visually examined for proper operation twice daily, Pf If transported off-site to a satellite location of the same business entity, equipped with verifiable electronic monitoring devices to ensure that times and temperatures are monitored during transportation, Pf and Labeled with the product name and the date PACKAGED; Pf and |
Maintain the records required to confirm that cooling and cold holding refrigeration time/temperature parameters are required as part of the HACCP PLAN and: Make such records available to the REGULATORY AUTHORITY upon request, Pf and Hold such records for at least 6 months; Pf and Implement written operational procedures as specified under Subparagraph (B)(5) of this section and a training program as specified under Subparagraph (B)(6) of this section. Pf |
Cheese | Except as specified under ¶ (F) of this section, a FOOD ESTABLISHMENT that PACKAGES cheese using a REDUCED OXYGEN PACKAGING method shall: Limit the cheeses PACKAGED to those that are commercially manufactured in a FOOD PROCESSING PLANT with no ingredients added in the FOOD ESTABLISHMENT and that meet the Standards of Identity as specified in 21 CFR 133.150 — Hard cheeses, 21 CFR 133.169 — Pasteurized process cheese or 21 CFR 133.187 — Semisoft cheeses; P Have a HACCP PLAN that contains the information specified by the DEPARTMENT under § 1-106.12 and as specified under ¶¶ (B)(1), (B)(3)(a), (B)(5), and (B)(6) of this section; Pf Labels the PACKAGE on the principal display panel with a “use by” date that does not exceed 30 days from its PACKAGING or the original manufacturer’s “sell by” or “use by” date, whichever occurs first; Pf and Discards the REDUCED OXYGEN PACKAGED cheese if it is not sold for off−PREMISES consumption or consumed within 30 calendar days of its PACKAGING. Pf |
A HACCP PLAN is not required when a FOOD ESTABLISHMENT uses a REDUCED OXYGEN PACKAGING method to PACKAGE TIME/TEMPERATURE CONTROL FOR SAFETY FOOD that is always: Labeled with the production time and date, Held at 5°C (41°F) or less during refrigerated storage, and Removed from its PACKAGE in the FOOD ESTABLISHMENT within 48 hours after PACKAGING. |
3−6 | FOOD IDENTITY, PRESENTATION, AND ON−PREMISES LABELING |
Subparts 3−601 Accurate Representation 3−602 Labeling 3−603 Consumer Advisory |
Accurate Representation | 3−601.11 Standards of Identity. PACKAGED FOOD shall comply with standard of identity requirements in 21 CFR 131 to 169 and 9 CFR 319 Definitions and standards of identity or composition, and the general requirements in 21 CFR 130 - Food Standards: General and 9 CFR 319 Subpart A - General. 3−601.12 Honestly Presented. FOOD shall be offered for human consumption in a way that does not mislead or misinform the CONSUMER. FOOD or COLOR ADDITIVES, colored overwraps, or lights may not be used to misrepresent the true appearance, color, or quality of a FOOD. |
Labeling | 3−602.11 Food Labels. FOOD PACKAGED in a FOOD ESTABLISHMENT, shall be labeled as specified in LAW, including 21 CFR 101 - Food labeling, and 9 CFR 317 Labeling, marking devices, and containers. Label information shall include: The common name of the FOOD, or absent a common name, an adequately descriptive identity statement; If made from two or more ingredients, a list of ingredients and subingredients in descending order of predominance by weight, including a declaration of artificial colors, artificial flavors and chemical preservatives, if contained in the FOOD; An accurate declaration of the net quantity of contents; The name and place of business of the manufacturer, packer, or distributor; and The name of the FOOD source for each MAJOR FOOD ALLERGEN contained in the FOOD unless the FOOD source is already part of the common or usual name of the respective ingredient. Pf Except as exempted in the Federal Food, Drug, and Cosmetic Act § 403 (q) (3) - (5), nutrition labeling as specified in 21 CFR 101 - Food Labeling and 9 CFR 317 Subpart B Nutrition Labeling. |
(7) For any salmonid FISH containing canthaxanthin or astaxanthin as a COLOR ADDITIVE, the labeling of the bulk FISH container, including a list of ingredients, displayed on the retail container or by other written means, such as a counter card, that discloses the use of canthaxanthin or astaxanthin. Bulk FOOD that is available for CONSUMER self−dispensing shall be prominently labeled with the following information in plain view of the CONSUMER: The manufacturer’s or processor’s label that was provided with the FOOD; or A card, sign, or other method of notification that includes the information specified under Subparagraphs (B)(1), (2), and (5) of this section. Bulk, unPACKAGED FOODS such as bakery products and unPACKAGED FOODS that are portioned to CONSUMER specification need not be labeled if: A health, nutrient content, or other claim is not made; and There are no state or local LAWS requiring labeling. The FOOD is manufactured or prepared on the PREMISES of the FOOD ESTABLISHMENT or at another FOOD ESTABLISHMENT or a FOOD PROCESSING PLANT that is owned by the same PERSON and is regulated by the FOOD regulatory agency that has jurisdiction. 3−602.12 Other Forms of Information. If required by LAW, CONSUMER warnings shall be provided. FOOD ESTABLISHMENT or manufacturers’ dating information on FOODS may not be concealed or altered. |
Consumer Advisory | 3−603.11 Consumption of Animal Foods that are Raw, Undercooked, or Not Otherwise Processed to Eliminate Pathogens. (A) Except as specified in ¶ 3−401.11 (C) and Subparagraph 3−401.11 (D)(4) and under ¶ 3−801.11 (C), if an animal FOOD such as beef, EGGS, FISH, lamb, pork , POULTRY, shellfish, or any other FOOD item allowed by LAW that is served or sold raw, undercooked, or without otherwise being PROCESSED to eliminate pathogens, either in READY−TO−EAT form or as an ingredient in another READY−TO−EAT FOOD, the LICENSE HOLDER shall inform CONSUMERS of the significantly increased RISK of consuming such FOODS by way of a DISCLOSURE and REMINDER, as specified in ¶¶ (B) and (C) of this section, using brochures, deli case or menu advisories, label statements, table tents, placards, or other effective written means. Pf |
DISCLOSURE shall include: A description of the animal−derived FOODS, such as “oysters on the half shell (raw oysters),” and “raw−EGG Caesar salad,” and “hamburgers (can be cooked to order);” Pf or Identification of the animal−derived FOODS by asterisking them to a footnote that states that the items are served raw or undercooked, or contain (or may contain) raw or undercooked ingredients. Pf REMINDER shall include asterisking the animal−derived FOODS requiring DISCLOSURE to a footnote that states: Regarding the safety of these items, written information is available upon request; Pf Whether dining out or preparing FOOD at home, consuming raw or undercooked MEATS, POULTRY, seafood, shellfish, or EGGS may increase your RISK of foodborne illness; Pf or Whether dining out or preparing FOOD at home, consuming raw or undercooked MEATS, POULTRY, seafood, shellfish, or EGGS may increase your RISK of foodborne illness, especially if you have certain medical conditions. Pf |
3−7 | CONTAMINATED FOOD Subparts 3−701 Disposition |
Disposition | 3−701.11 Discarding or Reconditioning Unsafe, Adulterated, or Contaminated Food. FOOD that is unsafe, ADULTERATED, or not honestly presented as specified under § 3−101.11 shall be discarded or reconditioned according to an APPROVED procedure. P FOOD that is not from an APPROVED source as specified under §§ 3−201.11 - 3−201.17 shall be discarded. P READY−TO−EAT FOOD that may have been contaminated by an EMPLOYEE who has been RESTRICTED or EXCLUDED as specified under § 2−201.12 shall be discarded. P FOOD that is contaminated by FOOD EMPLOYEES, CONSUMERS, or other PERSONS through contact with their hands, bodily discharges, such as nasal or oral discharges, or other means shall be discarded. P |
3−8 | SPECIAL REQUIREMENTS FOR HIGHLY SUSCEPTIBLE POPULATIONS Subparts 3−801 Additional Safeguards |
Additional Safeguards | 3−801.11 Pasteurized Foods, Prohibited Re-−Service, and Prohibited Food. In a FOOD ESTABLISHMENT that serves a HIGHLY SUSCEPTIBLE POPULATION: The following criteria apply to JUICE: For the purposes of this paragraph only, children who are age 9 or less and receive FOOD in a school, day care setting, or similar facility that provides custodial care are included as HIGHLY SUSCEPTIBLE POPULATIONS; PrePACKAGED JUICE or a prePACKAGED BEVERAGE containing JUICE, that bears a warning label as specified in 21 CFR 101.17 (g) Food labeling, warning, notice, and safe handling statements, JUICES that have not been specifically PROCESSED to prevent, reduce, or eliminate the presence of pathogens, or a PACKAGED JUICE or BEVERAGE containing JUICE, that bears a warning label as specified under ¶ 3−404.11 (B) may not be served or offered for sale; P and UnPACKAGED JUICE that is prepared on the PREMISES for service or sale in a READY−TO−EAT form shall be processed under a HACCP PLAN required by the DEPARTMENT under § 1-106.12, and as specified in 21 CFR 120 - Hazard Analysis and Critical Control Point (HACCP) Systems, Subpart B Pathogen Reduction, 120.24 Process controls. P Pasteurized EGGS or EGG PRODUCTS shall be substituted for raw EGGS in the preparation of: P FOODS such as Caesar salad, hollandaise or Béarnaise sauce, mayonnaise, meringue, EGGnog, ice cream, and EGG−fortified BEVERAGES, P and Except as specified in ¶ (F) of this section, recipes in which more than one EGG is broken and the EGGS are combined. P The following FOODS may not be served or offered for sale in a READY−TO−EAT form: P Raw animal FOODS such as raw FISH, raw−marinated FISH, raw MOLLUSCAN SHELLFISH, and steak tartare; P A partially cooked animal FOOD such as lightly cooked FISH, rare MEAT, soft−cooked EGGS that are made from raw shell EGGS, and meringue; P and |
(3) Raw seed sprouts. P FOOD EMPLOYEES may not contact READY−TO−EAT FOOD as specified under ¶¶ 3−301.11 (B) and (E). P Time only, as the public health control as specified under ¶ 3−501.19 (E), may not be used for raw EGGS and cheese curds. P Subparagraph (B)(2) of this section does not apply if: The raw EGGS are combined immediately before cooking for one CONSUMER’S serving at a single meal, cooked as specified under Subparagraph 3−401.11 (A)(1), and served immediately, such as an omelet, soufflé, or scrambled EGGS; The raw EGGS are combined as an ingredient immediately before baking and the EGGS are thoroughly cooked to a READY−TO−EAT form, such as a cake, muffin, or bread; or The preparation of the FOOD is conducted under a HACCP PLAN that: Identifies the FOOD to be prepared, Prohibits contacting READY−TO−EAT FOOD with bare hands, Includes specifications and practices that ensure: Salmonella Enteritidis growth is controlled before and after cooking, and Salmonella Enteritidis is destroyed by cooking the EGGS according to the temperature and time specified in Subparagraph 3−401.11 (A) (2), Contains the information specified by the DEPARTMENT under 1-106.12, including procedures that: Control cross contamination of READY−TO−EAT FOOD with raw EGGS, and Delineate cleaning and SANITIZATION procedures for FOOD−CONTACT SURFACES, and Describes the training program that ensures that the FOOD EMPLOYEE responsible for the preparation of the FOOD understands the procedures to be used. |
Re-service of Food | (G) Except as specified in Paragraph (H) of this section, FOOD may be re−served as specified under Subparagraph 3−306.14 (B)(1) and (2). |
Prohibited Re-service of Food | (H) FOOD may not be re−served under the following conditions: Any FOOD served to patients or clients who are under contact precautions in medical isolation or quarantine, or protective environment isolation may not be re−served to others outside. Packages of FOOD from any patients, clients, or other CONSUMERS should not be re−served to PERSONS in protective environment isolation. |
Parts | 4−1 MATERIALS FOR CONSTRUCTION AND REPAIR 4−2 DESIGN AND CONSTRUCTION |
4−3 | NUMBERS AND CAPACITIES |
4−4 | LOCATION AND INSTALLATION |
4−5 | MAINTENANCE AND OPERATION |
4−6 | CLEANING OF EQUIPMENT AND UTENSILS |
4−7 | SANITIZATION OF EQUIPMENT AND UTENSILS |
4−8 | LAUNDERING |
4−9 | PROTECTION OF CLEAN ITEMS |
4-1 | MATERIALS FOR CONSTRUCTION AND REPAIR Subparts 4−101 Multiuse |
4−102 | Single−Service and Single−Use |
Multiuse | 4−101.11 Characteristics. Materials that are used in the construction of UTENSILS and FOOD−CONTACT SURFACES of EQUIPMENT may not allow the migration of deleterious substances or impart colors, odors, or tastes to FOOD and under normal use conditions shall be: P Safe; P Durable, CORROSION−RESISTANT, and nonabsorbent; Sufficient in weight and thickness to withstand repeated WAREWASHING; Finished to have a SMOOTH, EASILY CLEANABLE surface; and Resistant to pitting, chipping, crazing, scratching, scoring, distortion, and decomposition. |
4−101.12 Cast Iron, Use Limitation. Except as specified in ¶¶ (B) and (C) of this section, cast iron may not be used for UTENSILS or FOOD−CONTACT SURFACES of EQUIPMENT. Cast iron may be used as a surface for cooking. Cast iron may be used in UTENSILS for serving FOOD if the UTENSILS are used only as part of an uninterrupted process from cooking through service. 4−101.13 Lead, Use Limitation. (A) Ceramic, china, and crystal UTENSILS, and decorative UTENSILS such as hand painted ceramic or china that are used in contact with FOOD shall be lead−free or contain levels of lead not exceeding the limits of the following UTENSIL categories: P
|
Pewter alloys containing lead in excess of 0.05% may not be used as a FOOD−CONTACT SURFACE. P Solder and flux containing lead in excess of 0.2% may not be used as a FOOD−CONTACT SURFACE. 4−101.14 Copper, Use Limitation. Except as specified in ¶ (B) of this section, copper and copper alloys such as brass may not be used in contact with a FOOD that has a pH below 6 such as vinegar, fruit JUICE, or wine or for a fitting or tubing installed between a backflow prevention device and a carbonator. P Copper and copper alloys may be used in contact with beer brewing ingredients that have a pH below 6 in the prefermentation and fermentation steps of a beer brewing operation such as a brewpub or microbrewery. |
4−101.15 Galvanized Metal, Use Limitation. Galvanized metal may not be used for UTENSILS or FOOD−CONTACT SURFACES of EQUIPMENT that are used in contact with acidic FOOD. P 4−101.16 Sponges, Use Limitation. Sponges may not be used in contact with cleaned and SANITIZED or in−use FOOD−CONTACT SURFACES. 4−101.17 Wood, Use Limitation. Except as specified in ¶¶ (B), (C), and (D) of this section, wood and wood wicker may not be used as a FOOD−CONTACT SURFACE. Hard maple or an equivalently hard, close−grained wood may be used for: Cutting boards; cutting blocks; bakers’ tables; and UTENSILS such as rolling pins, doughnut dowels, salad bowls, and chopsticks; and Wooden paddles used in confectionery operations for pressure scraping kettles when manually preparing confections at a temperature of 110°C (230°F) or above. Whole, uncut, raw fruits and vegetables, and nuts in the shell may be kept in the wood shipping containers in which they were received, until the fruits, vegetables, or nuts are used. If the nature of the FOOD requires removal of rinds, peels, husks, or shells before consumption, the whole, uncut, raw FOOD may be kept in: |
Untreated wood containers; or Treated wood containers if the containers are treated with a preservative that meets the requirements specified in 21 CFR 178.3800 Preservatives for wood. 4−101.18 Nonstick Coatings, Use Limitation. Multiuse KITCHENWARE such as frying pans, griddles, sauce pans, cookie sheets, and waffle bakers that have a perfluorocarbon resin coating shall be used with nonscoring or nonscratching UTENSILS and cleaning aids. 4−101.19 Nonfood−Contact Surfaces. NonFOOD−CONTACT SURFACES of EQUIPMENT that are exposed to splash, spillage, or other FOOD soiling or that require frequent cleaning shall be constructed of a CORROSION−RESISTANT, nonabsorbent, and SMOOTH material. |
Single−Service and Single−Use | 4−102.11 Characteristics. Materials that are used to make SINGLE−SERVICE and SINGLE−USE ARTICLES: May not: Allow the migration of deleterious substances, P or Impart colors, odors, or tastes to FOOD; and Shall be: Safe, P and Clean. |
