Tip of the Week - FSMA Are you ready?

The FDA Food Safety Modernization Act (FSMA) will be issuing Hazard Analysis and Risk Based Preventive Controls (HARPC) for human and animal food on August 30, 2015. The FDA has indicated that companies will have approximately one year to develop and implement HARPC requirements to prevent unsafe food in the marketplace. So what has changed?

Documented Preventive Food Safety Plans

Companies will now be required to have documented preventive food safety plan(s) based on the severity and likelihood of food safety risk(s) associated with the manufacturing, storage and distribution for your type of food. The emphasis will be on preventing Class 1 recalls for undeclared allergens and pathogens in Ready-to-Eat (RTE) foods. Although most companies have HACCP plans, it is unlikely that existing documentation will meet the requirements for HARPC which requires additional hazard analysis for radiological hazards and economically motivated adulteration.

Required Sections

Your food safety plan(s) consists of prerequisite programs, process steps and what operational programs you have in place to prevent unsanitary conditions. Food safety plan(s) must include the following after evaluating the food safety risk for your food and process:

  • Documented hazard analysis
  • Parameters for maximum/minimum values as applicable for those controls
  • Documented procedures for that activity or control
  • Documented corrective action
  • Verification for that activity or control
  • Validation of effectiveness as applicable

Further Information

Your preventive controls will not require the same level of documentation. If you need further assistance in determining the appropriate level of documentation, please review our guidance below and contact us if you need further assistance. For more information on compliance with FSMA, visit our website for “A FSMA-Ready Facility in 5 Easy Steps”.

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