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Issue Number: Council III 013


ROP 5: Requirement to submit HACCP plan to regulatory authority

Issue you would like the Conference to consider

The Reduced Oxygen Packaging (ROP) Committee is recommending that if a food establishment decides to conduct reduced oxygen packaging (ROP) without a variance as specified in Section 3-502.12 of the 2009 Food Code that the food establishment must first submit a copy of their HACCP plan to the regulatory authority. We do not recommend that the food establishment needs to await regulatory authority, but only to notify them through submission of the HACCP plan that they will be conducting ROP operations in conformance to the procedures enunciated in Section 3-502.12 of the 2009 Food Code.

Public Health Significance

Since the consequences of an ill conceived plan to conduct ROP operations in a food establishment can be serious, and since many food establishments are only inspected by their regulatory authority once or twice a year, requiring notification of the regulatory authority by the food establishment of ROP processes being implemented is a prudent requirement. This will allow the regulatory authority to be made immediately aware of the food establishment's intention to conduct ROP operations and will also give the regulatory authority the option to review the plan to ensure that the requirements of Sections 3-502.12 of the most current Food Code are being followed.

Prior approval is not recommended to facilitate a food establishment initiating operations without a lengthy review process. Furthermore, the Food Code is quite specific in its requirements to conduct this operation safely.

Recommended Solution: The Conference recommends...

that a letter be sent to the FDA requesting the 2009 Food Code (as modified by the Supplement issued in 2011) be amended as follows (using underlining for additions):

1) Add a new Subparagraph (7) to Subparagraph 3-502.12 (B)

3-502.12 Reduced Oxygen Packaging without a Variance, Criteria.

(B) A FOOD ESTABLISHMENT that PACKAGES POTENTIALLY HAZARDOUS FOOD (TIME/TEMPERATURE CONTROL FOR SAFETY FOOD) using a REDUCED OXYGEN PACKAGING method shall have a HACCP PLAN that contains the information specified under ¶ 8-201.14(D) and that: Pf...(Subparagraphs 1-6 are unchanged)

(7) Is provided to the regulatory authority prior to implementation.

2) Modify Paragraph 8-201.13 (B)

8-201.13 When a HACCP Plan is Required.

(B) A PERMIT applicant or PERMIT HOLDER shall have a properly prepared HACCP PLAN which is provided to the regulatory authority prior to implementation as specified under § 3-502.12.

Submitter Information

Name Brian A. Nummer, Ph.D., Chair
Organization Reduced Oxygen Packaging Committee
Address 8700 Old Main Hill
Utah State University
Logan, UT 84233
Telephone 435-797-2116
Fax 435-797-2379
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