(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
(2) 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
(a) Has a Aw of 0.91 or less, Pf
(b) Has a pH of 4.6 or less, Pf
(c) 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
(d) Is a FOOD with a high level of competing organisms such as raw MEAT, raw POULTRY, or raw vegetables; Pf
(3) 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
(a) Maintain the FOOD at 5°C (41°F) or below, Pf and
(b) 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
(4) 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
(5) Includes operational procedures that:
(a) Prohibit contacting READY-TO-EAT FOOD with bare hands as specified under ¶ 3-301.11 (B), Pf
(b) Identify a designated work area and the method by which: Pf
(i) Physical barriers or methods of separation of raw FOODS and READY-TO- EAT FOODS minimize cross contamination, Pf and
(ii) Access to the processing EQUIPMENT is limited to responsible trained personnel familiar with the potential HAZARDS of the operation,
Pf and
(c) Delineate cleaning and SANITIZATION procedures for FOOD-CONTACT SURFACES; Pf and
(6) Describes the training program that ensures that the individual responsible for the REDUCED OXYGEN PACKAGING operation understands the: Pf
(a) Concepts required for a safe operation, Pf
(b) EQUIPMENT and facilities, Pf and
(c) Procedures specified under Subparagraph (B) (5) of this section and ¶ 1-106.12. Pf
(1) 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
(2) Ensure the FOOD is:
(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 PACKAGED product to another business entity or the CONSUMER, Pf
(b) 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
(c) Protected from contamination before and after cooking as specified under Parts 3-3 and 3-4, P
(d) 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
(e) Cooled to 5°C (41°F) in the sealed PACKAGE or bag as specified under § 3-501.14 and: P
(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 PACKAGING; P
(ii) 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
(iii) Held frozen with no shelf life restriction while frozen until consumed or used. P
(f) 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
(g) 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
(h) Labeled with the product name and the date PACKAGED; Pf and
(3) Maintain the records required to confirm that cooling and cold holding refrigeration time/temperature parameters are required as part of the HACCP PLAN and:
(a) Make such records available to the REGULATORY AUTHORITY upon request, Pf and
(b) Hold such records for at least 6 months; Pf and
(4) 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
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(1) 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 — Semi-soft cheeses;
P
(2) 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
(3) 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
(4) 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
(F) 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:
(1) Labeled with the production time and date,
(2) Held at 5°C (41
°F) or less during refrigerated storage, and
