New FDA Guidance Document Clarifies FSMA’s Sanitary Transportation Rule
The U.S. Food and Drug Administration (FDA) has issued another guidance document, this time explaining a waiver to the Food Safety Modernization Act’s Sanitation Transportation rule.
This guidance is intended for those persons who are subject to the Sanitary Transportation of Human and Animal Food Rule (81 FR 20091), published on April 6, 2016. Specifically, this guidance provides clarification on the scope of the waiver for food establishments that provide food directly to consumers from the requirements of the Sanitary Transportation of Human and Animal Food Rule (the food establishment waiver) in response to questions the Agency has received since publication of the final rule.
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required.