December 14, 2017

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FDA Releases Small Entity Compliance Guide for FSMA Sanitary Transportation Rule

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 November 21, 2017, FDA announced the availability of a Small Entity Compliance Guide (SECG) to help small businesses understand the requirements of the Final Rule on the Sanitary Transportation of Human and Animal Food (Sanitary Transportation Rule). Small businesses have until April 6, 2018, to comply with the rule.

The SECG provides descriptions of the rule requirements in a question and answer format that includes information on topics such as training and record keeping. Comments may be submitted to FDA at any time. Instructions on how to submit comments are available in the Federal Register Notice available here (82 FR 55503).

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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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