Issue View | Council I | 2018 Biennial Meeting

This is a brand new Issue.

Amend Food Code 8-201.14 Contents of a HACCP Plan.

Section 8-201.14(C) of the 2013 Food Code currently requires a flow diagram or chart for each specific food or category type that includes certain elements outlined in (C)(1-5). One of these elements requires "the ingredients, materials and equipment used in the preparation of that food" (8-201.14(C)(4)) and another element requires "the formulations or recipe that delineates methods and procedural control measures that address the food safety concerns involved" (8-201.14(C)(5)) to be included in the flow diagram or chart. As defined on FDA's website (https://www.fda.gov/Food/GuidanceRegulation/HACCP/ucm2006801.htm), the purpose of a flow diagram is to provide a clear, simple outline of the steps involved in the process. Therefore, it is not appropriate to include elements such as ingredients, materials and equipment used in the preparation of that food or the formulations or recipe that delineates methods and procedural control measures that address the food safety concerns involved in a flow diagram or chart. Placing these two elements in a separate paragraph is more logical.

A properly prepared HACCP plan, as required in paragraph 8-201.14(D), should also include identification of the significant hazards. Therefore, identification of the significant hazards should be listed as a subparagraph in 8-201.14.

Lastly, firms that conduct reduced oxygen packaging are required by section 3-502.12 to provide operational procedures, yet firms engaged in other specialized processing methods are not required to do so. It would provide an additional level of public health protection to require all firms engaging in specialized processing to provide written operational procedures for how they will safely conduct these high risk processes. This should be listed as a subparagraph in 8-201.14.

Reformatting this section will provide additional clarification as to what is required in the contents of a HACCP plan and will align more closely with the HACCP guidance prepared by the National Advisory Committee on Microbiological Criteria for Foods.

that a letter be sent to the FDA requesting that Section 8-201.14 of the most current edition of the Food Code be amended as follows (language to be removed is in strikethrough format; new language is underlined):

8-201.14 - Contents of a HACCP Plan

For a food establishment that is required under § 8-201.13 to have a HACCP PLAN, the PERMIT applicant or PERMIT HOLDER shall submit to the REGULATORY AUTHORITY a properly prepared HACCP PLAN that includes:

(A) General information such as the name of the PERMIT applicant or PERMIT HOLDER, the FOOD ESTABLISHMENT address, and contact information;

(B) A categorization of the types of TIME/TEMPERATURE CONTROL FOR SAFETY FOODS that are to be controlled under the HACCP PLAN; ^Pf

(C) A flow diagram or chart for each specific FOOD or category type that identifies:

(1) Each step in the process; Pf

(2) The HAZARDS and controls for each step in the flow diagram or chart; Pf

(3) The steps that are CRITICAL CONTROL POINTS; Pf

(4) (D) The ingredients, materials, and equipment used in the preparation of that FOOD; Pf and (5) Formulations the formulations or recipes that delineate methods and procedural control measures that address the FOOD safety concerns involved. ^Pf

(D) (E) A CRITICAL CONTROL POINTS summary for each specific FOOD or category type that clearly identifies:

(1) Each CRITICAL CONTROL POINT, ^Pf

(2) The significant HAZARDS for each CRITICAL CONTROL POINT, ^Pf

(2) (3) The CRITICAL LIMITS for each CRITICAL CONTROL POINT, ^Pf

(3) (4) The method and frequency for monitoring and controlling each CRITICAL CONTROL POINT by the designated FOOD EMPLOYEE or the PERSON IN CHARGE, ^Pf

(4) (5) The method and frequency for the PERSON IN CHARGE to routinely verify that the FOOD EMPLOYEE is following standard operating procedures and monitoring CRITICAL CONTROL POINTS, ^Pf

(5) (6) Action to be taken by the designated FOOD EMPLOYEE or PERSON IN CHARGE if the CRITICAL LIMITS for each CRITICAL CONTROL POINT are not met, ^Pf and

(6) (7) Records to be maintained by the PERSON IN CHARGE to demonstrate that the HACCP PLAN is properly operated and managed; ^Pf

(E) (F) Supporting documents such as:

(1) FOOD EMPLOYEE and supervisory training plan and operating procedures that addresses the FOOD safety issues of concern; ^Pf

(2) Copies of blank records forms that are necessary to implement the HACCP PLAN; ^Pf

(3) Additional scientific data or other information, as required by the REGULATORY AUTHORITY, supporting the determination that FOOD safety is not compromised by the proposal. ^Pf

(F) (G) Any other information required by the REGULATORY AUTHORITY.