On April 6, 2016, the FDA published its Final Rule on Sanitary Transportation of Human and Animal Food establishing transportation requirements to ensure the safety of both human and animal food. This rule results from long-time concerns over the need for regulations so that foods are being transported in a safe manner. It reaffirms that transportation plays a critical role in preventing risks to the nation’s food supply.
The final rule is part of the implementation of the 2005 Sanitary Food Transportation Act (SFTA) and the 2011 FDA Food Safety Modernization Act (FSMA). These two statutes require the FDA to issue regulations requiring shippers, carriers by motor vehicles or rail vehicle, receivers, and other persons engaged in the transportation of food to use sanitary transportation practices to ensure that food is not transported under conditions that may render the food adulterated. The rule is one of seven fundamental rules proposed since January 2013 and is the sixth of seven regulations that have been finalized. This is also the only rule of the seven that is directly applicable to transportation.
The rule applies to shippers, loaders and carriers who transport food in the U.S. by motor vehicle or rail (whether or not food is offered or enters interstate commerce), and applies to food not completely enclosed by a container. Four key requirements are addressed: (1) vehicles and transportation equipment, (2) transportation operations, (3) records and (4) training. The new rule applies to the design and maintenance of vehicles and transportation equipment to ensure they do not cause the food being transported to become unsafe. It also requires specific measures be taken during the transport of food to ensure food safety, such as adequate temperatures. The rule requires carriers to train their personnel in sanitary transportation practices and to document the training conducted. Regulated parties must also maintain records of written procedures, agreements and training records (required for carriers).
So how will the rule on Sanitary Transportation of Human and Animal Food affect the transportation industry? First and foremost, the rule is flexible. It allows the industry to continue to use industry “best practices” which is defined as “commercial or professional procedures that are accepted or prescribed as being correct or most effective.” These practices include successful sanitation procedures, effective training programs, records retention procedures, successful inspection and monitoring programs.
The final rule indicates that businesses (other than small businesses) will have one year from date of publication to comply, so until April 7, 2017. Small businesses have 2 years to comply. “Small businesses” are defined as businesses other than motor carriers that are also not shippers and/or receivers and that employ fewer than 500 persons, and motor carriers having less than $27.5 million in annual receipts.
Before the rule becomes enforced in April 2017, those involved in the food transportation industry should review their vehicle and transportation equipment to determine how the new requirements may affect them. To comply with this new rule, all companies need to develop and implement a written procedure governing all aspects of their shipping operations. The procedure should spell out in detail the sanitation procedures for both loading and unloading and shipping equipment. If the current “best practices” are not suitable, then changes to the procedure must take place.
Failure to comply with the rule is subject to injunction and criminal prosecution. Further, food will be deemed “adulterated” if it is transported or offered for transport by a shipper, loader, carrier or receiver under conditions that don’t comply with the rule. FDA also intends to conduct some inspections and the Department of Transportation (DOT) will establish procedures for transportation safety inspections to be conducted by DOT or state agencies.
These new requirements may be used by plaintiffs to establish negligence and negligence per se, and may appear in litigation through discovery or FOIA requests. On the other hand, proper compliance with the rule will allow companies to prove safe and proper practices.
For more information on the Sanitary Transportation of Human and Animal Food visit: STHA Rule/2016/04/06/2016-07330/sanitary-transportation-of-human-and-animal-food
Anna Beck is an associate attorney at Roberts Perryman. Anna’s practice focuses on transportation, insurance coverage and defense.
Roberts Perryman has been a leader in transportation defense for over 50 years with offices in St. Louis and Springfield, MO and Belleville, IL. http://www.robertsperryman.com