§ 46.402. Reduced oxygen packaging.

 (a)  General requirement. A food facility that packages food using a reduced oxygen packaging method—where Clostridium botulinum is identified as a microbiological hazard in the final packaged form of the food—shall ensure that there are at least two barriers in place to control the growth and toxin formation of Clostridium botulinum. This requirement does not apply to a food facility that has obtained a variance under §  46.401 (relating to variance requirement for specialized processing methods).

 (b)  HACCP plan requirement. A food facility that packages food using a reduced oxygen packaging method—where Clostridium botulinum is identified as a microbiological hazard in the final packaged form of the food—shall have an HACCP plan that contains the information specified in §  46.1122(b)(4) (relating to HACCP plans) and that does all of the following:

   (1)  Identifies the food to be packaged.

   (2)  Limits the food packaged to a food that does not support the growth of Clostridium botulinum because it complies with one of the following:

     (i)   Has an a_w of 0.91 or less.

     (ii)   Has a pH of 4.6 or less.

     (iii)   Is a meat or poultry product cured at a food establishment regulated by USDA using substances specified in 9 CFR 424.21 (relating to use of food ingredients and sources of radiation), and is received in an intact package.

     (iv)   Is a food with a high level of competing organisms such as raw meat or raw poultry.

   (3)  Specifies methods for maintaining food at 5°C (41°F) or below.

   (4)  Describes how the packages shall be prominently and conspicuously labeled on the principal display panel in bold type on a contrasting background, with instructions to do the following:

     (i)   Maintain the food at 5°C (41°F) or below.

     (ii)   For food held at refrigeration temperatures, discard the food within 14 calendar days of its packaging if it is not served for on-premises consumption, or it is not consumed if served or sold for off-premises consumption.

   (5)  Limits the refrigerated shelf life to no more than 14 calendar days from packaging to consumption or the original manufacturer’s “sell by” or “use by” date, whichever occurs first.

   (6)  Includes operational procedures that do all of the following:

     (i)   Prohibit contacting food with bare hands.

     (ii)   Identify a designated area and the method by which physical barriers or methods of separation of raw foods and ready-to-eat foods minimize cross contamination, and access to the processing equipment is limited to responsible trained personnel familiar with the potential hazards of the operation.

     (iii)   Cleaning and sanitization procedures for food-contact surfaces are delineated.

   (7)  Describes the training program that ensures that the individual responsible for the reduced oxygen packaging operation understands concepts required for a safe operation, the equipment and facilities, and the procedures specified in paragraph (6) and §  46.1122(b)(4).

 (c)  Special limitation with respect to certain fish. Except for fish that is frozen before, during and after packaging, a food facility may not package fish using a reduced oxygen packaging method.

   This section cited in 7 Pa. Code §  46.1122 (relating to HACCP plans).