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FDA Releases Food Safety Plan Builder To Help Food Plants Develop Food Safety Plans

The FDA this week released its Food Safety Plan Builder (FSPB), a tool designed to help operators of food facilities with the development of food safety plans that are specific to their facilities and meet the requirements of the preventive controls for human food regulation.

Use of the FSPB is strictly optional on the part of the user, FDA emphasized. The agency is not requiring use of this tool to develop a facility’s food safety plan.

Although the content of the Food Safety Plan Builder v. 1.0 is consistent with FDA’s existing guidance and regulations, use of the FSPB by owners and operators of food facilities does not mean that their food safety plan, preventive controls, good manufacturing practices and other food safety procedures are approved by FDA or comply with FDA requirements.

Included in the Food Safety Plan Builder are:
Facility information: In this tab, information adequate to identify the plant or facility is noted with a red asterisk. The information that identifies a facility such as company/facility name, city, state, country, postal code and facility identifier number(s), will appear at the top of each of the applicable summary reports, and at the top of a company’s food safety plan.

Preliminary steps: This tab may serve as a useful framework for organizing and documenting important food safety-related characteristics of the products manufactured at a facility.

Good Manufacturing Practices and Prerequisite Programs: This tab serves as a checklist for the good manufacturing practice and other prerequisite programs that govern the basic facility environmental and operating conditions and provide a foundation for a facility’s food safety plan.

Hazard analysis and preventive controls determination: Facilities must conduct a hazard analysis to identify known or reasonably foreseeable hazards for each type of food manufactured, processed, packed or held at a facility and determine whether any of the hazards require a preventive control. The hazard analysis must be written regardless of its outcome and must consider biological, chemical and physical hazards.

Process Preventive Controls: Process controls include procedures, practices, and processes to ensure the control of parameters during operations. Process controls must include, as appropriate to the nature of applicable preventive control and its role in the facility’s food safety system: parameters associated with the control of the hazard, and the maximum or minimum value, or combination of values, to which any biological, chemical, or physical parameter must be controlled to significantly minimize or prevent a hazard requiring a process control.

Food Allergen Preventive Controls: Controls must include those procedures, practices and processes employed for ensuring that food is protected from allergen cross-contact, including during storage, handling and use, as well as ensuring accurate labeling of the finished food product.

Sanitation Preventive Controls: Procedures, practices, and processes to ensure that the facility is maintained in a sanitary condition adequate to significantly minimize or prevent hazards such as environmental pathogens, biological hazards due to employee handling, and food allergen hazards.

Supply-Chain Preventive Controls: A receiving facility must establish and implement a risk-based supply-chain program for those raw materials and other ingredients for which it has identified a hazard requiring a supply-chain-applied control.

Recall Plan: Facilities that have identified a hazard requiring a preventive control are required to develop a written recall plan.

Reanalysis of Food Safety Plan:
Verifying that the food safety plan is still applicable and relevant is the focus of reanalysis.

Food Safety Plan Report: The responses entered within each of the tabs in the Food Safety Plan Builder are automatically compiled into a single document, which then serves as a food safety plan.

Signature: This tab allows the food plan to be signed by the owner, operator, or agent in charge.

Recordkeeping Procedures: Serves as a checklist to determine if all records required by the GMP and preventive controls rule have been developed and all mandatory procedures have been followed.
Important Contacts: It may be useful to organize important contact information in this tab.

Supporting Documents: This tab allows users to add links to documents and URLs to resources that support the food safety plan.

The Food Safety Plan Builder can be downloaded at: https://www.accessdata.fda.gov/scripts/foodsafetyplanbuilder/.