410 IAC 7-26-218 Criteria for reduced oxygen packaging without a variance

Sec. 218. (a) Except for a retail food establishment that obtains a variance as specified under section 217 of this rule, a retail food establishment that packages TCS food using a reduced oxygen packaging method shall control the growth and toxin formation of Clostridium botulinum and the growth of Listeria monocytogenes. (b) Except as specified under subsection (f), a retail food establishment that packages TCS food using a reduced oxygen packaging method shall implement a HACCP plan that contains the information specified under section 486(a)(3) and 486(a)(4) of this rule and includes all the following: (1) Identifies the food to be packaged. (2) Except as specified under subsections (c) through (e), requires the packaged food must be maintained at not more than forty-one (41) degrees Fahrenheit, five (5) degrees Celsius and meet at least one (1) of the following criteria: (A) Has an aw of not more than 0.91. (B) Has a pH of not more than 4.6. (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 and is received in an intact package. (D) Is a food with a high level of competing organisms, such as raw meat, poultry, or vegetables. (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: (A) maintain the food at forty-one (41) degrees Fahrenheit, five (5) degrees Celsius, or below; and (B) discard the food within thirty (30) calendar days of its packaging if: (i) it is not served for on-premises consumption; or (ii) consumed if served or sold for off-premises consumption. (4) Limits the refrigerated shelf life to not 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. (5) Includes operational procedures that include all the following: (A) Prohibit contacting ready-to-eat food with bare hands as specified under section 173 of this rule. (B) Identify a designated work area and the method by which: (i) physical barriers or methods of separation of raw foods and ready-to-eat foods minimize cross-contamination; and (ii) access to the processing equipment is limited to responsible trained personnel familiar with the potential hazards of the operation. (C) Delineate cleaning and sanitization procedures for food contact surfaces. (6) Describes the training program that ensures that the individual responsible for the reduced oxygen packaging operation understands the: (A) concepts required for a safe operation; (B) equipment and facilities; and (C) procedures specified under subdivision (5) and section 486(a)(3) and 486(a)(4) of this rule. (7) Is provided to the regulatory authority before implementation as specified under section 485(b) of this rule. (c) Except for fish that is frozen before, during, and after packaging and bears a label indicating it is to be kept frozen until time of use, a retail food establishment may not package fish using a reduced oxygen packaging method. (d) Except as specified under subsections (c) and (f), a retail food establishment that packages TCS food using a cook-chill or sous vide process shall do the following: (1) Provide to the regulatory authority, before implementation, a HACCP plan that contains the information as specified under section 486(a)(3) and 486(a)(4) of this rule. (2) Ensure the food is as follows: (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. (B) Cooked to heat all parts of the food to a temperature and for a time as specified under section 198(a) through 198(c) of this rule. (C) Protected from contamination before and after cooking as specified under sections 173 through 207 of this rule. (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 one hundred thirty-five (135) degrees Fahrenheit, fifty-seven (57) degrees Celsius. (E) Cooled to forty-one (41) degrees Fahrenheit, five (5) degrees Celsius, in the sealed package or bag as specified under section 192 of this rule and: (i) cooled to thirty-four (34) degrees Fahrenheit, one (1) degree Celsius, within forty-eight (48) hours of reaching forty-one (41) degrees Fahrenheit, five (5) degrees Celsius, and held at that temperature until consumed or discarded within thirty (30) days after the date of packaging; (ii) held at forty-one (41) degrees Fahrenheit, five (5) degrees Celsius, for not more than seven (7) days, at which time the food must be consumed or discarded; (iii) Cooled to thirty-four (34) degrees Fahrenheit, one (1) degree Celsius, within forty-eight (48) hours of reaching forty-one (41) degrees Fahrenheit, five (5) degrees Celsius, removed from refrigeration equipment that maintains a thirty-four (34) degrees Fahrenheit, one (1) degree Celsius, food temperature, and held at forty-one (41) degrees Fahrenheit, five (5) degrees Celsius or less for not more than seven (7) days, not to exceed thirty (30) days from its date of packaging, at which time the food must be consumed or discarded; or (iv) held frozen with no shelf life restriction while frozen until consumed or used. (F) Held in a refrigeration unit equipped with an electronic system that continuously monitors time and temperature and is visually examined for proper operation twice daily. (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. (H) Labeled with the product name and the date packaged. (3) Maintain the records required to confirm that cooling and cold holding refrigeration time and temperature parameters are required as part of the HACCP plan and: (A) make those records available to the regulatory authority on request; and (B) hold those records for at least six (6) months. (4) Implement written operational procedures as specified under subsection (b)(5), and a training program as specified under subsection (b)(6). (e) Except as specified under subsection (f), a retail food establishment that packages cheese using a reduced oxygen packaging method shall do all the following: (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, 21 CFR 133.169, or 21 CFR 133.187. (2) Have a HACCP plan that contains the information specified under section 486(a)(3) and 486(a)(4) of this rule, and as specified under subsection (b)(1), (b)(3)(A), (b)(5), and (b)(6). (3) Label 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. (4) Discard the reduced oxygen packaged cheese if it is not sold for off-premises consumption or consumed within thirty (30) calendar days of its packaging. (f) A HACCP plan is not required when a retail food establishment uses a reduced oxygen packaging method to package TCS food that is always: (1) labeled with the production time and date; (2) held at forty-one (41) degrees Fahrenheit, five (5) degrees Celsius, or less during refrigerated storage; and (3) removed from its package in the retail food establishment within forty-eight (48) hours after packaging. (g) For purposes of this section, a violation of subsection (a), (b)(4), (c), (d)(2)(B), (d)(2)(C), (d)(2)(D), (d)(2)(E), or (e)(1) is a P item. (h) For purposes of this section, a violation of subsection (b)(1), (b)(2), (b)(3), (b)(5), (b)(6), (d)(1), (d)(2)(A), (d)(2)(F), (d)(2)(G), (d)(2)(H), (d)(3), (d)(4), (e)(2), (e)(3), or (e)(4) is a PF item. (i) For purposes of this section, a violation of subsection (b)(7) is a core item.