(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
(B) Label information shall include:
(1) The common name of the FOOD, or absent a common name, an adequately descriptive identity statement;
(2) 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;
(3) An accurate declaration of the net quantity of contents;
(4) The name and place of business of the manufacturer, packer, or distributor; and
(5) 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
(6) 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.
(C) Bulk FOOD that is available for CONSUMER self-dispensing shall be prominently labeled with the following information in plain view of the CONSUMER:
(1) The manufacturer's or processor's label that was provided with the FOOD; or
(2) A card, sign, or other method of notification that includes the information specified under Subparagraphs (B)(1), (2), and (5) of this section.
(D) Bulk, unPACKAGED FOODS such as bakery products and unPACKAGED FOODS that are portioned to CONSUMER specification need not be labeled if:
(1) A health, nutrient content, or other claim is not made; and
(2) There are no state or local LAWS requiring labeling.
(3) 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.
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(B) DISCLOSURE shall include:
(1) 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
(2) 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
(C) REMINDER shall include asterisking the animal-derived FOODS requiring DISCLOSURE to a footnote that states:
(1) Regarding the safety of these items, written information is available upon request; Pf
(2) 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
(A) The following criteria apply to JUICE:
(1) 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;
(2) 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
(3) 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
(B) Pasteurized EGGS or EGG PRODUCTS shall be substituted for raw EGGS in the preparation of: P
(1) FOODS such as Caesar salad, hollandaise or Béarnaise sauce, mayonnaise, meringue, EGGnog, ice cream, and EGG-fortified BEVERAGES, P and
(2) Except as specified in ¶ (F) of this section, recipes in which more than one EGG is broken and the EGGS are combined. P
(C) The following FOODS may not be served or offered for sale in a READY-TO-EAT form: P
(1) Raw animal FOODS such as raw FISH, raw-marinated FISH, raw MOLLUSCAN SHELLFISH, and steak tartare; P
(2) 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
(D) FOOD EMPLOYEES may not contact READY-TO-EAT FOOD as specified under ¶¶ 3-301.11 (B) and (E). P
(E) 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
(F) Subparagraph (B)(2) of this section does not apply if:
(1) 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;
(2) 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
(3) The preparation of the FOOD is conducted under a HACCP PLAN that:
(a) Identifies the FOOD to be prepared,
(b) Prohibits contacting READY-TO-EAT FOOD with bare hands,
(c) Includes specifications and practices that ensure:
(i) Salmonella Enteritidis growth is controlled before and after cooking, and
(ii) Salmonella Enteritidis is destroyed by cooking the EGGS according to the temperature and time specified in Subparagraph 3-401.11 (A) (2),
(d) Contains the information specified by the DEPARTMENT under 1-106.12, including procedures that:
(i) Control cross contamination of READY-TO-EAT FOOD with raw EGGS, and
