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FDA Releases Sixth Chapter of Draft Guidance for the Human HARPC Rule

  • As our readership is well aware, 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.

  • To facilitate compliance with the new requirements, FDA has been in the process of rolling out a comprehensive draft guidance document for industry, in stages, entitled, “Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food”.

  • Today, the FDA announced the availability of the sixth chapter of the draft guidance for food facilities that explains how to establish and implement a heat treatment, such as baking or cooking, to prevent contamination by disease-causing bacteria.

  • FDA indicates that it intends to publish at least 14 chapters altogether and will continue to announce the availability of each chapter as it becomes available.

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© 2020 Keller and Heckman LLPNational Law Review, Volume VII, Number 242
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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...

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