FSMA Final Rule Published on Sanitary Transportation of Human and Animal Food

April 20, 2016

The Final Rule contains notable changes from what was originally proposed.

The US Food and Drug Administration (FDA) published its final rule earlier this month regarding Sanitary Transportation of Human and Animal Food (Final Rule).[1] The Final Rule is part of FDA’s implementation of the Food Safety Modernization Act (FSMA) and the Sanitary Food Transportation Act and establishes requirements for shippers, loaders, carriers by motor or rail vehicle, and receivers involved in transporting human and animal food to use sanitary practices to ensure the safety of that food. The requirements do not apply to transportation by air or ship.

The Final Rule establishes four basic requirements:

  1. Vehicle and transportation equipment must be used, maintained, and stored in a manner that does not cause food to become unsafe during transportation operations.
  2. The development of effective measures to take during transportation operations to prevent food from becoming unsafe. Measures may include adequate temperature controls, segregation, isolation, or other protective measures to prevent contamination of ready-to-eat food from touching raw food, protection of food from contamination by nonfood items in the same load or previous load, and protection of food from cross-contact.
  3. Adequate training for carrier personnel that provides an awareness of food safety problems and basic sanitary transportation practices to address those problems.
  4. Maintenance of records of written procedures, agreements, and training. Although the retention time of the record varies according to the type of record and the occurrence of the covered activity, the retention time may not exceed 12 months.

According to the Final Rule, FDA received about 240 comments on the proposed rule[2] and, in response, made several revisions to it. Generally, the revisions help focus the Final Rule on issues concerning food safety. Additionally, the revisions attempt to be consistent with industry safe transportation best practices. One of the key changes in the Final Rule was exempting shippers, loaders, receivers, and carriers engaged in the transportation operations of food while the food is located in food facilities that are regulated exclusively, throughout the entire facility, by the US Department of Agriculture (USDA). However, the Final Rule does discuss the existence of dual-jurisdiction establishments—essentially, those that prepare, pack, hold, or otherwise handle foods regulated by both USDA and FDA. For those establishments, FDA would inspect in accordance with its existing Memorandum of Understanding with USDA.[3] Other notable changes in the Final Rule include the following:

  • Simplifying the definitions of the covered parties subject to the rule, as well as adding “loaders” to those subject to the rule. The Final Rule defines “loaders” as people who load food onto a motor or rail vehicle during transportation operations.
  • Modifying the definition of “transportation operations” to exclude (with certain exceptions)
    • transport of foods completely enclosed by a container;
    • all transportation activities performed by a farm;
    • transport of human food byproducts for use as animal food without further processing;
    • transport of food contact substances, which include coatings, plastics, paper, and adhesives, as well as colorants, antimicrobials, and antioxidants found in packaging; and
    • transport of live food animals, except for molluscan shellfish (such as oysters, clams, mussels, and scallops)—the original proposal excluded all live food animals, including molluscan shellfish.
  • Clarifying that shippers have the primary responsibility, unless some of these responsibilities are contractually assigned to another entity, for determining the appropriate transportation operations.
  • Clarifying that the intended use of a vehicle or equipment with respect to the type of food that is being transported (e.g., transporting animal feed versus foods for humans), as well as the production stage of the transported food (e.g., raw materials, ingredients, or finished products), should be considered for applicability of the Final Rule’s requirements.
  • Requiring that, if a person covered by the rule becomes aware of a possible failure of temperature control or any other condition that may render a food unsafe, food must not be sold or distributed until a determination of safety is made by a qualified individual.

The Final Rule also discusses the circumstances and general process for obtaining a waiver that would exempt an otherwise covered entity. A waiver may be granted in response to a submitted petition or on the FDA’s own initiative. The granting of the waiver will be based on whether it would be contrary to the public interest and not result in the transportation of food under unsafe conditions. The FDA will publish a notice in the Federal Register that sets forth the waiver and the reasons for it.

In terms of effective and compliance dates, the Final Rule indicates that businesses (other than small businesses) would have one year from the Final Rule’s date of publication (April 6, 2017). Small businesses would have two years to comply (April 6, 2018). The Final Rule defines “small businesses” as businesses other than motor carriers that are not also shippers and/or receivers and that employ fewer than 500 persons and motor carriers having less than $27.5 million in annual receipts.

Next Steps

Given the variety of changes in the Final Rule, those involved in food transportation should do the following:

  • Review their vehicle and transportation equipment to determine how the new requirements may affect them
  • Review the definition of “transportation operations” to determine if their activity is one of the additional activities not covered by the rule
  • Review current sanitary transportation practices to determine compliance with new requirements
  • Review current recordkeeping policy and procedures to determine adequacy as compared to the Final Rule requirements

The FDA is planning a webinar on April 25 from 11:00 a.m. to 12:00 p.m. eastern time to present key pieces of the Final Rule. More information on the webinar can be found on the FSMA website.


If you have any questions or would like more information on the issues described in this LawFlash, please contact any of the following lawyers:

Washington, DC
Gary L. Yingling

[1] 81 Fed. Reg. 20092 (Apr. 6, 2016), available at

[2] 79 Fed. Reg. 7006 (Feb. 5, 2014), available at

[3] Memorandum of Understanding between the Food Safety & Inspection Service, US Dept. of Agriculture and the Food & Drug Admin., US Dept. of Health & Human Svcs (MOU 225-99-2001) (Feb. 23, 1999), available at