1. (a) Except for a retail food establishment that obtains a variance as specified under 20 CAR § 192-502, 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

2. (b) Except as specified under subsection (f) of this section, a retail food establishment that packages time/temperature control for safety food using a reduced oxygen packaging method shall have an HACCP plan that contains the information specified under 20 CAR § 197-201(d)(2) and (4) and that: ^Pf

   1. (1) Identifies the food to be packaged; ^Pf

   2. (2) Except as specified under subsections (c) – (e) of this section, requires that the packaged food shall be maintained at five degrees Celsius (5°C) (forty-one degrees Fahrenheit (41°F)) or less and meet at least one (1) of the following criteria: ^Pf

      1. (A) Has an a_w of ninety-one hundredths (0.91) or less; ^Pf
      2. (B) Has a pH of four and six tenths (4.6) or less; ^Pf
      3. (C) Is a meat or poultry product cured at a food processing plant regulated by the United States Department of Agriculture using substances specified in 9 C.F.R. § 424.21, Use of food ingredients and sources of radiation, and is received in an intact package; ^Pf or
      4. (D) Is a food with a high level of competing organisms such as raw meat, raw poultry, or raw vegetables; ^Pf

   3. (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

      1. (A) Maintain the food at five degrees Celsius (5°C) (forty-one degrees Fahrenheit (41°F)) or below; ^Pf and
      2. (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. (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 and

   5. (5) Includes operational procedures that:

      1. (A) Prohibit contacting ready-to-eat food with bare hands, under 20 CAR § 192-301(a)(2); ^Pf
      2. (B) Identify a designated work area and the method by which: ^Pf

3. (i) Physical barriers or methods of separation of raw foods and ready-to-eat foods minimize cross-contamination; ^Pf and

   1. (ii) Access to the processing equipment is limited to responsible trained personnel familiar with the potential hazards of the operation; ^Pf

      1. (C) Delineate cleaning and sanitization procedures for food-contact surfaces; ^Pf

      2. (D) Describe the training program that ensures that the individual responsible for the reduced oxygen packaging operation understands the: ^Pf

         1. (i) Concepts required for a safe operation; ^Pf
         2. (ii) Equipment and facilities; ^Pf and(5)
         3. (iii) Procedures specified under subdivision (b)(5) of this section and 20 CAR § 197-201(d)(2) and (4); ^Pf and

      3. (E) Are provided to the regulatory authority prior to implementation as specified under 20 CAR § 197-201(c)(2).

         1. (c) Except for fish that is frozen before, during, and after packaging, a retail food establishment may not package fish using a reduced oxygen packaging method. ^P
         2. (d) Except as specified under subsections (c) and (f) of this section, a retain food establishment that packages time/temperature control for safety food using a cook-chill or sous vide process shall:
   2. (1) Provide to the regulatory authority before implementation an HACCP plan that contains the information as specified under 20 CAR § 197-201(d)(2) and (4); ^Pf

   3. (2) Ensure the food is:

      1. (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
      2. (B) Cooked to heat all parts of the food to a temperature and for a time as specified under 20 CAR § 192-401(a)(1) – (3); ^P
      3. (C) Protected from contamination before and after cooking as specified under 20 CAR § 192-301 et seq., and 20 CAR § 192-401 et seq.; ^P
      4. (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 fifty-seven degrees Celsius (57°C) (one hundred thirty-five degrees Fahrenheit (135°F)); ^P

      5. (E) Cooled to five degrees Celsius (5°C) (forty-one degrees Fahrenheit (41°F)) in the sealed package or bag as specified under 20 CAR § 192-501(d) and: ^P

         1. (i) Cooled to one degree Celsius (1°C) (thirty-four degrees Fahrenheit (34°F)) within forty-eight (48) hours of reaching five degrees Celsius (5°C) (forty-one degrees Fahrenheit (41°F)) and held at that temperature until consumed or discarded within thirty (30) days after the date of packaging; ^P
         2. (ii) Held at five degrees Celsius (5⁰C) (forty-one degrees Fahrenheit (41⁰F)) or less for no more than seven (7) days, at which time the food must be consumed or discarded; ^P or
         3. (iii) Held frozen with no shelf-life restriction while frozen until consumed or used; ^P
      6. (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
      7. (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
      8. (H) Labeled with the product name and the date packaged; ^Pf

   4. (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:

      1. (A) Make such records available to the regulatory authority upon request; ^Pf and
      2. (B) Hold such records for at least six (6) months; ^Pf and
   5. (4) Implement written operational procedures as specified under subdivision (b)(5) of this section and a training program as specified under (B)(6) of this section. ^Pf

4. (e) Except as specified under subsection (f) of this section, a retail food establishment that packages cheese using a reduced oxygen packaging method shall:

   1. (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 C.F.R. § 133.150, Hard cheeses, 21 C.F.R. § 133.169, Pasteurized process cheese, or 21 C.F.R. § 133.187, Semisoft cheeses; ^P
   2. (2) Have an HACCP plan that contains the information specified under 20 CAR § 197-201(d)(2) and (4) and as specified under subdivisions (b)(1), (b)(3)(A), and (b)(5) of this section; ^Pf
   3. (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. (4) Discards the reduced-oxygen-packaged cheese if it is not sold for off-premises consumption or consumed within thirty (30) calendar days of its packaging. ^Pf

5. (f) An 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. (1) Labeled with the production time and date;
   2. (2) Held at five degrees Celsius (5⁰C) (forty-one degrees Fahrenheit (41⁰F)) or less during refrigerated storage; and
   3. (3) Removed from its package in the retail food establishment within forty-eight (48) hours after packaging.

Codification Notes: “HACCP” means hazard analysis and critical control point.