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The Food and Drug Administration (FDA) recently issued a Notice that provides three types of waivers from the requirements of the Sanitary Transportation of Human and Animal Food rule (Sanitary Transportation rule). Specifically, FDA has made waivers available in specific circumstances for companies operating under the Pasteurized Milk Ordinance (PMO), food establishments that provide food directly to consumers, and companies operating under the Interstate Shellfish Sanitation Conference’s National Shellfish Sanitation Program (NSSP).
In the Notice, FDA both expands and clarifies the scope of the waivers originally proposed in the Sanitary Transportation rule.
This Notice publishing the waivers is significant because it is the agency’s first substantive food related Federal Register notice issued under the new administration. This notice was not subject to Executive Order (EO) 13771 (i.e., the order establishing the “one in, two out” rule) because is purely deregulatory in nature and only confers savings to all affected parties, consistent with the Office of
Management and Budget’s (OMB’s) guidance on the EO. FDA explains the deregulatory nature of the waivers in the notice:
The issuance of these waivers is deregulatory in nature because they lessen the burden imposed on shippers, receivers, loaders, and carriers engaged in transportation operations without impairing our ability to ensure the safety of food. The waivers will remove certain classes of persons from having to comply with the requirements of part 1, subpart O.
Below we provide an overview of the three different types of waivers from the Sanitary Transportation rule. These waivers became effective immediately upon publication of the Notice in the Federal Register. Note that the Sanitary Transportation rule is now in effect, as we have passed the April 6, 2017 compliance date for large companies.
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Authored by Joe Levitt, Maile Hermida, Elizabeth Fawell, and Samantha Dietle.