(3) The CONSUMER-owned container returned to the FOOD ESTABLISHMENT for refilling is refilled for sale or service only to the same CONSUMER; and
(4) The container is refilled by:
(a) An EMPLOYEE of the FOOD ESTABLISHMENT, or
(b) The owner of the container if the BEVERAGE system includes a contamination-free transfer process as specified under ¶¶ 4-204.13(A), (B), and (D) that cannot be bypassed by the container owner.
(D) Consumer-owned, personal take-out BEVERAGE containers, such as thermally insulated bottles, nonspill coffee cups, and promotional BEVERAGE glasses, may be refilled by EMPLOYEES or the CONSUMER if refilling is a contamination-free process as specified under ¶¶ 4-204.13(A), (B), and (D).
(2) 68
°C (155
°F) for 15 seconds or the temperature specified in the following chart that corresponds to the holding time for RATITES, MECHANICALLY TENDERIZED, and INJECTED MEATS; the following if they are COMMINUTED: FISH, MEAT, GAME ANIMALS commercially raised for FOOD as specified under Subparagraph 3-201.17 (A) (1), and GAME ANIMALS under a voluntary inspection program as specified under Subparagraph 3-201.17 (A)(2); and raw EGGS that are not prepared as specified under Subparagraph (A)(1)(a):
P
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(3) 74°C (165°F) or above for 15 seconds for POULTRY, BALUTS, wild GAME ANIMALS as specified under ¶ 3-201.17 (A)(3) and (4), stuffed FISH, stuffed MEAT, stuffed pasta, stuffed POULTRY, stuffed RATITES, or stuffing containing FISH, MEAT, POULTRY, or RATITES. P
(B) Whole MEAT roasts including beef, corned beef, lamb, pork, and cured pork roasts such as ham, shall be cooked:
(1) In an oven that is preheated to the temperature specified for the roast's weight in the following chart and that is held at that temperature:
Pf
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; 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:
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(C) A raw or undercooked WHOLE-MUSCLE, INTACT BEEF steak may be served or offered for sale in a READY-TO-EAT form if:
(1) The FOOD ESTABLISHMENT serves a population that is not a HIGHLY SUSCEPTIBLE POPULATION,
(2) The steak is labeled to indicate that it meets the definition of “WHOLE-MUSCLE, INTACT BEEF” as specified under ¶ 3-201.11 (E), and
(3) 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.
(D) 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:
(1) As specified under¶¶ 3-801.11 (C)(1) and (2), the FOOD ESTABLISHMENT serves a population that is not a HIGHLY SUSCEPTIBLE POPULATION;
(2) The FOOD, if served or offered for service by CONSUMER selection from a children's menu, does not contain COMMINUTED MEAT; Pf and
(3) 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
(4) The DEPARTMENT grants a VARIANCE from ¶ (A) or (B) of this section as specified in § 1-105.11 based on a HACCP PLAN that:
(a) Is submitted by the LICENSE HOLDER and APPROVED as specified under § 1-106.13,
(b) Documents scientific data or other information showing that a lesser time and temperature regimen results in a safe FOOD, and
(A) Subject to an initial heating process that is no longer than sixty minutes in duration; P
(B) 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
(C) After cooling, held frozen or cold, as specified for TIME/TEMPERATURE CONTROL SAFETY FOOD under ¶ 3-501.16 (A) (2); P
(D) 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
(E) 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
(F) Prepared and stored according to written procedures that:
(1) Have obtained prior APPROVAL from the REGULATORY AUTHORITY;
Pf
(2) Are maintained in the FOOD ESTABLISHMENT and are available to the REGULATORY AUTHORITY upon request; Pf
(3) 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
(4) 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
(5) 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.
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(C) 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.
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(A) Under refrigeration that maintains the FOOD temperature at 5
°C (41°F) or less; Pf or
(B) Completely submerged under running water:
(1) At a water temperature of 21°C (70°F) or below, Pf
(2) With sufficient water velocity to agitate and float off loose particles in an overflow, Pf and
(3) 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:
(a) The time the FOOD is exposed to the running water and the time needed for preparation for cooking, Pf or
(b) The time it takes under refrigeration to lower the FOOD temperature to 5°C (41°F); Pf
(C) As part of a cooking process if the FOOD that is frozen is:
(1) Cooked as specified under ¶ 3-401.11 (A) or (B) or § 3-401.12, Pf or
(2) Thawed in a microwave oven and immediately transferred to conventional cooking EQUIPMENT, with no interruption in the process; Pf or
(D) 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.
(E) 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:
(1) Prior to its thawing under refrigeration as specified in ¶ (A) of this section; or
(1) The day the original container is opened in the FOOD ESTABLISHMENT shall be counted as Day 1; Pf and
(2) 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
(C) 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
(D) A date marking system that meets the criteria stated in ¶¶ (A) and (B) of this section may include:
(1) 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;
(2) 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;
(3) 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
(4) 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.
(E) 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.
(F) Paragraphs (A) and (B) of this section do not apply to SHELLSTOCK.
(G) 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:
(1) 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;
(2) 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;
(3) 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;
(4) Cultured dairy products as defined in 21 CFR 131 Milk and cream, such as yogurt, sour cream, and buttermilk;
(5) Preserved FISH products, such as pickled herring and dried or salted cod, and other acidified FISH products defined in 21 CFR 114 Acidified foods;
(6) Shelf stable, dry fermented sausages, such as pepperoni and Genoa ; and
(7) 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).
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(2) Is in a container or PACKAGE that does not bear a date or day;
P or
(3) Is appropriately marked with a date or day that exceeds a temperature and time combination as specified in ¶ 3-501.17 (A). P
(B) 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
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(3) The FOOD shall be marked or otherwise identified to indicate:
Pf
(a) The time when the FOOD is removed from 5°C (41°F) or less cold holding temperature control, Pf and
(b) The time that is 6 hours past the point in time when the FOOD is removed from cold holding temperature control; Pf
(4) The FOOD shall be:
(a) Discarded if the temperature of the FOOD exceeds 21°C (70°F),P or
(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;
P and
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(E) 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.
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(D) 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
(E) Operating a MOLLUSCAN SHELLFISH life-support system display tank used to store or display shellfish that are offered for human consumption;
Pf
(F) Custom processing animals that are for personal use as FOOD and not for sale or service in a FOOD ESTABLISHMENT; Pf
(G) Preparing FOOD by another method that is determined by the DEPARTMENT to require a VARIANCE; Pf or
(H) Sprouting seeds or beans. Pf
(I) The slaughter and evisceration of FISH, other than MOLLUSCAN SHELLFISH.
Pf
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(B) 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
(1) Identifies the FOOD to be PACKAGED; Pf