FDA Issues PMO Waiver Sought by NMPF for Sanitary Transportation Act

In early April, the U.S. Food and Drug Administration (FDA) announced three waivers to the final Sanitary Transportation rule mandated by the Food Safety Modernization Act (FSMA), including the Pasteurized Milk Ordinance (PMO) waiver long sought by NMPF.

NMPF has advocated for several years for a waiver for PMO-regulated facilities. When the initial Sanitary Transportation of Human and Animal Food rule was proposed, FDA said it intended to waive the rule’s requirements in certain cases “in which they would not be needed to further protect foods from becoming unsafe.”

The waiver, to be issued soon, applies to inbound raw milk, outbound shipments of milk and cream, and shipments of finished Grade “A” milk products from PMO-regulated facilities.

As part of the regulatory process, NMPF asked for clarification about the phrase “only when transporting Grade ‘A’ milk and milk products” out of concern that most outbound shipments of finished Grade “A” products do not comprise only Grade “A” products, but include non-Grade “A” products like orange juice or ice tea. Thus, the waiver could be viewed as nullifying an outbound shipment containing both Grade “A” and non-Grade “A” products.

FDA declined to provide any further insight, but NMPF holds that outbound shipments of finished products from a PMO-regulated facility are not subject to the rule, even if the shipment contains non-Grade “A” products. For more information about this rule or the waiver, please contact Clay Detlefsen.