Earlier this week, the FDA published three anticipated waivers to the Food Safety Modernization Act’s Sanitary Transportation of Human and Animal Food Rule. The waivers may be of interest to certain shippers, carriers, and receivers of Grade “A” milk and milk products, food establishments that transport food, and businesses that transport molluscan shellfish.

Under Section 416(d) of the Federal Food, Drug, and Cosmetic Act, FDA can waive the requirements of the Sanitary Transportation Rule if the FDA determines that the waiver will not result in the transportation of food under conditions that would be unsafe for human and animal health and will not be contrary to the public interest. Pursuant to this authority, FDA announced over three years ago that it intended to issue certain waivers. After considering comments on the waivers and determining that they would not negatively impact public health or result in the transportation of food under conditions unsafe to human or animal health, or otherwise be contrary to the public interest, the FDA issued the final waivers for the following entities:

  • Permitted businesses that are inspected under the National Conference on Interstate Milk Shipments’ Grade “A” Milk Safety Program, but only when transporting Grade “A” milk and milk products.
  • Food establishments, such as restaurants, grocery stores, and home grocery delivery services, while operating (1) as a receiver or (2) as a shipper and carrier when food is delivered directly to consumers or to other locations that the food establishments or affiliates operate that serve or sell food directly to consumers.
  • Businesses that are certified and inspected under the requirements established by the Interstate Shellfish Sanitation Conference’s (ISSC) National Shellfish Sanitation Program (NSSP) and transport molluscan shellfish in ISSC permitted vehicles.

The final Sanitary Transportation Rule was published on April 6, 2016, with compliance deadlines of April 6, 2018 for small businesses (businesses other than motor carriers who are not also shippers and/or receivers employing fewer than 500 persons and motor carriers having less than $27.5 million in annual receipts) and April 6, 2017 for all others not small and not subject to waiver or otherwise excluded from coverage.