ARTICLE
18 April 2017

FDA Amends Waivers To Sanitary Transportation Rule

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Jones Day

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On March 24, 2017, FDA, USDA's Food Safety and Inspection Service, and the Centers for Disease Control and Prevention issued their second Strategic Plan for years 2017–2021.
United States Food, Drugs, Healthcare, Life Sciences

On April 6, 2017, the Food and Drug Administration ("FDA") notified industry regarding the amendment of waivers available under the Sanitary Transportation of Human and Animal Food rule ("Sanitary Transportation Rule"). Specifically, FDA has made some clarifications to the language previously used, such as modifying the language of the waivers to clarify their applicability only to businesses subject to the requirements of 21 CFR part 1, subpart O, and specifying that the Grade "A" milk waiver applies to the transportation of bulk and finished Grade "A" milk products only. FDA also clarified the food establishment waiver for businesses that provide food directly to consumers to better express the types of businesses within its scope, and to incorporate established definitions in 21 CFR 1.227 to describe the food establishments for which this waiver is available (i.e., restaurants, retail food establishments, and nonprofit food establishments). Additionally, FDA has revised the waiver language to make clear that it applies to receiving and delivery operations of a food establishment that are part of the normal business operations of the establishment, and has modified the language of the FDA has also granted a waiver for businesses that are appropriately certified and are inspected under the requirements established by the Interstate Shellfish Sanitation Conference's National Shellfish Sanitation Program ("NSSP"), but only when such businesses are engaged in transportation operations involving molluscan shellfish in vehicles that are permitted by the state NSSP certification authority.

The waivers are effective as of April 6, 2017.

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