September 29, 2020

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September 29, 2020

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September 28, 2020

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FDA Launches Food Safety Plan Builder to Facilitate FSMA Compliance

  • The Food Safety Modernization Act (FSMA) Final Rule for Preventive Controls for Human Food was published on September 17, 2015 (80 FR 55907), and compliance dates for some businesses began in September 2016.  The final rule implements hazard analysis and risk-based preventive controls (HARPC) for human food production. The new HARPC requirements implemented by the final rule are codified at 21 CFR Part 117, Subpart C. A corresponding Draft Guidance document is available here. The Draft Guidance explains FDA’s current thinking on how to comply with certain HARPC requirements and specifically addresses how food producers should go about developing an appropriate food safety plan.

  • On August 22, 2017, FDA launched the Food Safety Plan Builder (FSPB), a free software application developed by FDA to further assist businesses meet the requirements of the FSMA Final Rule for Preventive Controls for Human Food.  The software is downloadable from FDA’s website and is designed to guide businesses, step-by-step, through the creation of a food safety plan, as required by FSMA. FDA has released videos that provide tutorials on how to use the FSPB software.

  • Use of the software is strictly optional. FDA is not requiring use of this tool to develop a facility’s food safety plan, but use of the software could potentially help companies organize their food safety information and minimize the burden of creating their food safety plan. Manufacturers with questions about how to use the FSPB software may contact FDA at:

© 2020 Keller and Heckman LLPNational Law Review, Volume VII, Number 235


About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...