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FDA's Proposed Sanitary Transportation of Human and Animal Food Rule Could Impact Food-Contact Materials

February 21, 2014

The U.S. Food and Drug Administration's (FDA) proposed rule on the Sanitary Transportation of Human and Animal (see 79 Federal Register 7006 (Feb. 5, 2014)) would apply to shippers, receivers, and carriers (with some exceptions) who transport food in the U.S. by motor or rail vehicles. The proposed rule, which partially implements the Sanitary Food Transportation Act of 2005 as required by the Food Safety Modernization Act (FSMA), incorporates the definition of food found in section 201(f) of the Food Drug, and Cosmetic Act (FD&C Act), which includes food-contact materials.

FDA provided several examples to illustrate that the scope of the sanitary transportation proposed rule applies only to food directly transported in the U.S. by motor or rail vehicle. One example provided is an ingredient that is shipped, carried, and received only within China is not covered, even if that ingredient is later exported to the U.S. and incorporated into food sold in the U.S.

The proposed rule would:

  • Establish design and maintenance requirements for vehicles and transportation equipment;
  • Specify measures to be taken during transportation, such as temperature controls and separation of food from non-food items in the same load;
  • Provide procedures for exchange of information about prior cargos, cleaning of transportation equipment, and temperature control between the shipper, carrier, and receiver;
  • Establish required training for carrier personnel in sanitary transportation practices and documentation of the training;
  • Establish recordkeeping requirements; and
  • Outline the procedures by which FDA will waive any of these requirements.

While food-contact material are potentially subject to the requirements of this proposed rule, fully packaged shelf-stable foods—along with compressed food gasses and live food animals—are exempted. FDA explained that fully packaged shelf-stable foods and food gasses are exempted because they are not at risk of microbial spoilage. Interestingly, many of the other requirements established under FSMA only apply to a "food facility" that is required to register with FDA pursuant to Section 415 of the FD&C Act. FDA regulations implementing the Section 415 explicitly exclude food-contact substances from the definition of food.

The effective date for businesses subject to the new requirements would be 60 days after the final rule is published. However, compliance will be staggered with one year after the effective for regular businesses and two years for small businesses. Comments on the proposed rule are due by May 31, 2014. A fact sheet on the proposed rule is available on FDA's website.