New Food and Drug Administration (“FDA”) rules mandated by the US Food Safety Modernization Act (“FSMA”) are forthcoming for the transportation of food. The FSMA represents the most significant expansion of food safety requirements and FDA food safety mandates since the original enactment of the Federal Food, Drug, and Cosmetic Act (“FD&C”) Act of 1938. The FSMA grants the FDA a number of new powers, including mandatory recall authority, which the agency has sought for many years. The FSMA requires the FDA to undertake more than a dozen rule-makings and issue at least ten (“10”) guidance documents, as well as a host of reports, plans, strategies, standards, notices, and other tasks. The law requires the FDA to implement, in part, the Sanitary Food Transportation Act of 2005 and to promulgate regulations requiring shippers, carriers by motor vehicle 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 food adulterated. FSMA § 111, 124 Stat. at 3916 (amending 21 U.S.C. § 350e). Although regulations were due within 18 months after enactment of the FSMA, by July 4, 2012, the FDA was unable to meet this deadline. Now, the US court [Center for Food Safety v. Hamburg, 4:12‐cv‐ 04529 (N.D. Cal.)] has ordered that the FDA:
Publish proposed rules by Jan. 31, 2014 for Sanitary Transportation of Food
Close the comment period by May 31, 2014
Issue final rules for Sanitary Transportation of Food by June 30, 2015
13 Key Elements of FSMA: Sanitary Food Transportation Act
The following key elements are likely to be in play during the rule-making process for the Sanitary Food Transportation Act:
Temperature Monitoring and Control
Improper refrigeration or temperature control of food products (temperature abuse)
Improper management of transportation units or storage facilities to preclude cross-contamination, including improper sanitation, backhauling hazardous materials, improper disposal of wastewater etc.
Segregating food and non-foods in the same trailer/container/railcar to minimize the potential risk of cross-contamination from nonfood items.
Improper packing of transportation units or storage facilities, including incorrect use of packing materials and poor pallet quality;
Improper loading practices, conditions, or equipment, including improper sanitation of loading equipment, not using dedicated units where appropriate, inappropriate loading patterns and transporting mixed loads that increase the risk for cross-contamination;
Improper unloading practices, conditions, or equipment, including improper sanitation of equipment and leaving raw materials on loading docks for extended periods of time
Trailer/Truck Washing Requirements
Food sanitation procedures for air and equipment surface contacts
Training management and employees on the basics of food safety
Environmental monitoring programs to verify effectiveness of pathogen controls in processes where food is exposed to a potential contaminate in the environment.
Supplier verification that relate to food safety
Food Safety Plan
A food safety plan that is documented and being followed
Current good manufacturing practices (cGMP’s)
Revisit Your Food Safety Program to Ensure Compliance
Although the final rules are unlikely to be exactly the same as the proposed rules, there is no time like the present to revisit your transportation and logistics food safety program and to get a head start on the forthcoming rules and regulations. The opportunity to take action is now for those who are likely to be impacted directly or indirectly by the Food Safety Modernization Act and the Sanitary Food Transportation Act. The industry has a golden opportunity to help shape the very rules that will govern their food transportation operations and impact their success and bottom line.
By Dr. Patrick Brecht, PhD, PEB Commodities & member of the WFLO Scientific Advisory Council (SAC). Dr. Brecht joined the SAC in late August 2013, bringing his extensive transport-related experience as a professor and corporate executive. He has also authored publications recognized as key industry reference guides.