801.1 A food processing operation that packages food using a reduced oxygen packaging method, with Clostridium botulinum identified as the target organism for destruction in the final packaged form shall in addition to modifying the oxygen content use at least two (2) of the following barriers: refrigeration, pH, or water activity to control the growth and toxin formation of Clostridium botulinum.

801.2 A food processing operation that packages food using a reduced oxygen packaging method with Clostridium botulinum identified as a microbiological hazard in the final packaged form, shall have a HACCP plan that complies with the requirements of section 704 and:

(a) Contains a flow diagram by specific food or category type identifying critical control points and providing information on the following:

(1) Ingredients, materials, and equipment used in the preparation of that food; and

(2) Formulations or recipes that delineate methods and procedural control measures that address the food safety concerns involved;

(b) Contains a statement of standard operating procedures for the plan that clearly identifies the following:

(1) Each critical control point;

(2) The critical limits for each critical control point;

(3) The method and frequency for monitoring and controlling each critical control point by the food employee designated by a supervisor;

(4) The method and frequency for supervisors to routinely verify that the food employee is following standard operating procedures and monitoring critical control points;

(5) Action to be taken by supervisors if the critical limits for each critical control point are not met; and

(6) Records to be maintained by supervisors to demonstrate that the HACCP plan is properly operated and managed;

(c) Identifies the food to be packaged;

(d) Limits the food packaged to a food that does not support the growth of Clostridium botulinum because it meets with one (1) of the following criteria:

(1) Has an aw of ninety-one hundredths (0.91) or less;

(2) Has a pH of four and six tenths (4.6) or less;

(3) Is a meat or poultry product cured at a food processing operation regulated by the USDA and is received in an intact package; or

(4) Is a food with a high level of competing organisms, such as raw meat or raw poultry;

1. (e) Specifies methods for maintaining food at forty-one degrees ( $41^\circ$ F) (five degree Centigrade ( $5^\circ$ C)) or below;
2. (f) 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:
3. (1) Maintain the food at forty-one degrees Fahrenheit ( $41^\circ$ F) (five degree Centigrade ( $5^\circ$ C)) or below; and
4. (2) Discard the food if within fourteen (14) calendar days of its packaging it is not sold for consumption;
5. (g) Limits the shelf life to no more than fourteen (14) calendar days from packaging to consumption or the original manufacturer's 'sell by' or 'use by' date, whichever occurs first;
6. (h) Includes operational procedures that prohibit contacting food with bare hands;
7. (i) Includes operational procedures that identify a designated area and the method by which:
8. (1) Physical barriers or methods of separation of raw foods and ready-to-eat foods minimize cross contamination; and
9. (2) Access to the processing equipment is restricted to responsible trained personnel familiar with the potential hazards of the operation;
10. (j) Delineates cleaning and sanitization procedures for food-contact surfaces; and
11. (k) Describes the training program that ensures that the individual responsible for the reduced oxygen packaging operation understands the:
12. (1) Concepts required for a safe operation;
13. (2) Equipment and facilities; and
14. (3) Procedures specified under sections 801.2(b) and 801.2(h) - (j).

SOURCE: Final Rulemaking published at 56 DCR 5245 (July 3, 2009).