June 17, 2018

June 15, 2018

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FDA Clarifies Sanitary Transportation Rule Waiver for Retail Food Establishments

  • As previously covered on this blog, on April 6, 2016, FDA published a final rule to implement sanitary food transportation requirements under the FDA Food Safety Modernization Act (FSMA).  Click here for a complete copy of the final rule.  Click here for an FDA fact sheet summarizing the final rule, and click here for our summary of the rule and its implications for entities in the food industry.  In short, the final rule establishes sanitary transportation practices for covered entities addressing: (1) vehicles and transportation equipment; (2) transportation operations; (3) training; (4) records; and (5) waivers. The compliance date for most companies was April 2017.  Small businesses have until April 2018 to comply.
  • On April 5, 2017, FDA announced the publication of three waivers to the final Sanitary Transportation rule. The waivers are for businesses whose transportation operations are subject to existing regulatory controls at the federal, state or local levels, including one that waives certain requirements for restaurants, retail food establishments, and nonprofit food establishments. See previous blog coverage here.
  • On August 14, 2017, FDA issued guidance to clarify that a waiver to the Sanitary Transportation of Human and Animal Food final rule (Sanitary Transportation rule) covers retail food establishments that sell food for humans, including those that sell both human and animal food, but does not apply to establishments that only sell food for animals.
  • We will continue to monitor and report on FDA’s activities in connection with the final Sanitary Transportation rule and other FSMA related activities.  
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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...