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). 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:
According to the Final Rule, FDA received about 240 comments on the proposed rule 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. Other notable changes in the Final Rule include the following:
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.
Given the variety of changes in the Final Rule, those involved in food transportation should do the following:
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:
 81 Fed. Reg. 20092 (Apr. 6, 2016), available at https://www.gpo.gov/fdsys/pkg/FR-2016-04-06/pdf/2016-07330.pdf.
 79 Fed. Reg. 7006 (Feb. 5, 2014), available at https://www.gpo.gov/fdsys/pkg/FR-2014-02-05/pdf/2014-02188.pdf.
 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 http://www.fda.gov/AboutFDA/PartnershipsCollaborations/MemorandaofUnderstandingMOUs/DomesticMOUs/ucm117094.htm.