Current through Register Vol. 48, No. 10, October 25, 2024
Section 61-25.3-502 - Specialized Processing Methods3-502.11Special Processes Requiring a Variance.A retail food establishment shall obtain a variance from the Department as specified in 8-103.10 and under 8-103.11 before: Pf
(A) Smoking food as a method of food preservation rather than as a method of flavor enhancement;Pf(C) Using food additives or adding components such as vinegar: Pf(1) As a method of food preservation rather than as a method of flavor enhancement, Pf or(2) To render a food so that it is not a time/temperature control of safety food; Pf(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) Custom processing animals that are for personal use as food and not for sale or service in a food establishment; Pf(F) Preparing food by another method that is determined by the Department to require a variance; Pf(G) Sprouting seeds or beans; Pf or(H) Using additives or acidification when the process is for flavor enhancement only. Retail food establishments using additives or acidification for flavor enhancement only shall provide a written statement, in lieu of a HACCP plan, which shall describe foods prepared and essential safety measures implemented.3-502.12Reduced Oxygen Packaging Without a Variance, Criteria.(A) Except for a retail food establishment that obtains a variance as specified under 3-502.11, a retail 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(B) Except as specified under (F) of this section, a retail 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 under 8-201.14(C) and (D) and that: Pf(1) Identifies the food to be packaged; Pf(2) Except as specified under (C) through (E) of this section, requires that the packaged food shall be maintained at 41 degrees F (5 degrees C) or less and meet at least one of the following criteria: Pf(a) Has an 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 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 41 degrees F (5 degrees C) or below, Pf and(b) Discard the food if within thirty (30) calendar days of its packaging 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 thirty (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 (B)(5) of this section and 8-201.14 (C) and (D).Pf(7) Is provided to the Department prior to implementation as specified under 8-201.13 (B).(C) Except for fish that is frozen before, during, and after packaging and bears a label indicating that it is to be kept frozen until time of use, a retail food establishment may not package fish using a reduced oxygen packaging method. P(D) Except as specified under (C) and (F) of this section, a retail food establishment that packages time/temperature control for safety food using a cook-chill or sous vide process shall: (1) Provide to the Department prior to implementation a HACCP plan that contains the information as specified under 8-201.14 (C) and (D); 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 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 135 degrees F (57 degrees C),P(e) Cooled to 41 degrees F (5 degrees C) in the sealed package or bag as specified under 3-501.14 and: P(i) Cooled to 34 degrees F (1 degrees C) within forty-eight (48) hours of reaching 41 degrees F (5 degrees C) and held at that temperature until consumed or discarded within thirty (30) days after the date of packaging; P(ii) Held at 41 degrees F (5 degrees C) or less for no more than seven (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 Department upon requestPf and(b) Hold such records for at least six (6) months; Pf and(4) Implement written operational procedures as specified under (B)(5) of this section and a training program as specified under (B)(6) of this section. Pf(E) Except as specified under (F) of this section, a retail food establishment that packages cheese using a reduced oxygen packaging method shall:(1) Limit the cheeses packaged to those that are commercially manufactured in a food processing plant with no ingredients added in the retail 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(2) Have a HACCP plan that contains the information specified under 8-201.14 (C) and (D) 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 thirty (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 retail 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 41 degrees F (5 degrees C) or less during refrigerated storage, and(3) Removed from its package in the retail food establishment within forty-eight (48) hours after packaging.S.C. Code Regs. § 61-25.3-502
Replaced and amended by State Register Volume 38, Issue No. 6, eff 6/27/2014; State Register Volume 43, Issue No. 05, eff. 5/24/2019.