Reduced Oxygen Packaged (ROP) Products

Because of the potential for severe, life-threatening illness associated with improperly canned reduced oxygen packaging (ROP) products, such activity must be subjected to a very detailed and documented review and approval process.

This requires detailed HACCP plans, product testing and process authority approval, and may require a regulatory waiver. This is in addition to the normal review and permitting process for a commercial food processing permit.

Note: Canning for sale to the public cannot be done from the home. Visit the Plan Review and Home-Based Food Businesses webpages for summarized food establishment requirements.

Water-bath canned or otherwise non-retorted canned/ROP products produced within Clark County may follow these guidelines:

Heat-treated (190°F for 10 minutes), ROP packaged products that, in their original acidified formulation, are verified to be a non-potentially hazardous food by lab testing with an Aw of .88 or below, or a pH of 4.2 or below, will not be subject to section 3-502.12 for ROP packaging, provided that the applicant:

  1. Obtain Process Authority product assessment indicating that all hazards of concern are controlled, based on process review and Aw & pH test results;
  2. Provide proof of completion of a “better process control school” (BPCS) curriculum for acidified foods;
  3. Obtains a pH meter for the testing of each batch produced; the test results will be documented and available for review on inspection; the meter must be calibrated per manufacturers specifications, and each product will be tested by a certified lab annually (and available for review on inspection);
  4. Submits a detailed operational plan intended to standardize formulation of each product, which must include proper heat treatment (190°F for 10 minutes), the packaging of the product while it is still hot, aseptic methods for sealing the containers, and calibration procedures for the pH meters;
  5. Maintains records to ensure critical limits are attained, including cooking temperatures, pH values for batch testing, annual Aw and pH testing, and pH meter calibration per manufacturers specifications;
  6. Produce and maintain prerequisite programs / sanitary standard operating procedures including Sanitation, Employee Hygiene, No Bare Hand Contact, Employee Training and Employee Health, that meet minimum standards set by the health district.

Non-heat treated ROP packaged products (such as fresh salsa) that, in their original formulation, are verified to be a non-potentially hazardous food by lab testing with an Aw of .88 or below, or a pH of 4.2 or below, will not be subject to section 3-502.12 for ROP packaging, provided a three-barrier method is followed as noted:

  1. A detailed operational plan must be submitted to standardize formulation of each product and specifically intended to control for the growth of Listeria monocytogenes and Clostridium botulinum for each product or group of similar products, and must include an Aw of .88 or below, or a pH of 4.2 or below (barrier 1), a high level of competing organisms (barrier 2), and temperature control at 41°F for a 14 day refrigerated shelf life (barrier 3).
  2. Product label must read “KEEP REFRIGERATED” and have a use-by date of 14 days from packaging;
  3. A pH meter or Aw meter (depending on proof provided of non-PHF/TCS status) must be obtained and used to test each batch produced; the test results will be documented and available for review on inspection; the meter must be calibrated per manufacturers specifications; and each product will be tested by a certified lab annually (and available for review on inspection);
  4. Sanitation, No Bare Hand Contact, Employee Hygiene, Employee Training and Employee Health prerequisite programs and sanitary standard operating procedures that meet minimum standards set by the health district must be produced and maintained.

Whether heat-treated or non-heat-treated ROP packaged products that, in their original formulation, are verified by lab testing as having an Aw of .91- .89, or a pH of 4.6-4.3, will be subject to section 3-502.12 for ROP packaging.

All permit applications for ROP packaging of products must include:

  1. A basic HACCP plan that meets minimum regulatory requirements of 4-101.15 and 3-502.12, which are intended specifically to control for the growth of Listeria monocytogenes and Clostridium botulinum for each product or group of similar products, and includes critical control points, critical limits, monitoring and corrective actions for pH or Aw, cooling, and temperature control at 41°F for a 14 day refrigerated shelf life.
  2. Product label must read “KEEP REFRIGERATED” and provide a use-by date of 14 days from packaging;
  3. A pH meter or Aw meter (depending on proof provided of non-PHF/TCS status) must be obtained and used to test each batch produced; the test results will be documented and available for review on inspection; the meter must be calibrated per manufacturers specifications; and each product will be tested by a certified lab once annually (and available for review on inspection);
  4. Sanitation, No Bare Hand Contact, Employee Hygiene, Employee Training and Employee Health prerequisite programs and sanitary standard operating procedures that meet minimum standards set by the health district must be produced and maintained.

Local food processors wishing to produce ROP product outside of these guidelines, wishing to use a combination of Aw and pH to show proof of non-PHF/TCS status, or wishing to have a HACCP Plan Critical Limit less than health district regulatory requirements, must apply for a waiver in addition to providing a HACCP plan as noted above.

The waiver application must show proof of process authority approval for each process, and must specify products and formulations so approved. The process authority approval must include microbiological challenge study results showing that each specific product formulation does not support the growth of Listeria monocytogenes and Clostridium botulinum.

Additional Information

  • Detailed requirements are provided in the Food Regulations Section 3-502.12.
  • Summarized food establishment requirements are available on the Food Processing Facilities webpage.
  • View the Plan Review Process webpage for a description of the application and approval process.
  • Details about Reduced Oxygen Packaging risks and concerns are available in the Food Regulations Appendix L.

Contact Information

Phone:
(702) 759-1258

Make a Complaint

 

Updated on: October 11, 2018

2018-10-11T16:24:50+00:00