Thursday, April 6, 2017

FDA Issues 3 Waivers to Sanitary Transport Rule, Including Shipments by Retail Outlets

With the Sanitary Transport Rule coming, FDA announced three waivers - 1) those permitted to ship milk, 2) those shipping food directly to consumers or as part of the operations of a foodservice / retail outlets, and 3) those approved to ship shellfish.

More specifically, from the FDA on item number two, this gives a waiver to grocery stores and food-service establishments.  It covers food sold directly to the consumer as well as food within the company or affiliate (a supermarket hub operation shipping to one of their stores).
  • "Businesses that are permitted or otherwise authorized by the regulatory authority to operate a food establishment that provides food directly to consumers (including restaurants, retail food establishments, and nonprofit food establishments, as defined in 21 CFR 1.227), only when engaged in transportation operations as:
    • Receivers, whether the food is received at the establishment itself or at a location where the authorized establishment receives and immediately transports the food to the food establishment;
    • Shippers and carriers in operations in which food is transported from the establishment as part of the normal business operations of a retail establishment, such as:
      • delivery of the food directly to the consumer(s) by the authorized establishment or a third-party delivery service or
      • delivery of the food to another location operated by the authorized establishment or an affiliated establishment where the food is to be sold or served directly to the consumer(s)."
FDA News Release

FDA Announces Three Waivers to Sanitary Transportation Rule

April 5, 2017

When the Sanitary Transportation of Human and Animal Food rule was proposed, the U.S. Food and Drug Administration 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.

Today, the FDA announced the publication of three waivers to the now final Sanitary Transportation rule mandated by the FDA Food Safety Modernization Act (FSMA).

The waivers are for businesses whose transportation operations are subject to separate State-Federal controls. They include:
  • Businesses holding valid permits that are inspected under the National Conference on Interstate Milk Shipments’ Grade “A” Milk Safety Program, only when transporting Grade “A” milk and milk products. 
  • Food establishments authorized by the regulatory authority to operate when engaged as receivers, or as shippers and carriers in operations in which food is delivered directly to consumers, or to other locations the establishments or affiliates operate that serve or sell food directly to consumers. (Examples include restaurants, supermarkets and home grocery delivery services.) 
  • Businesses transporting molluscan shellfish (such as oysters, clams, mussels or scallops) that are certified and inspected under the requirements established by the Interstate Shellfish Sanitation Conference’s (ISSC) National Shellfish Sanitation Program (NSSP) and that transport the shellfish in vehicles permitted under ISSC authority. 
The FSMA rule on Sanitary Transportation of Human and Animal Food is part of the FDA’s effort to protect foods from farm to table by keeping them safe from contamination during transportation. The rule establishes requirements for shippers, loaders, carriers by motor or rail vehicle, and receivers involved in transporting human and animal food.

These waivers are being published after being described in the proposed and final rule. FDA considered comments on the waivers and found that the waivers would not result in the transportation of food under conditions that would be unsafe for human or animal health, or contrary to the public interest.

More information regarding the Sanitary Transportation rule (including a discussion of the comments we received on these waivers), and any of the FSMA provisions, is available at

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