Prompted by the Sanitary Food Transportation Act of 2005 and the Food Safety Modernization Act of 2011 (FSMA), the Food and Drug Administration (FDA) issued a new rule entitled "Sanitary Transportation of Human and Animal Food" (the SFT Rule). The SFT Rule establishes the requirements for sanitary transportation practices that will apply beginning April 6, 2017.
The SFT Rule does not solve or purport to solve any clearly identified problem but is part of an overall "paradigm shift" that switches priorities from responding to outbreaks to preventing them in the first place. Under the SFT Rule, when any covered person at any point in the transportation supply chain becomes aware of a condition, including temperature control failure, that could render the food unsafe, that food must not be sold or distributed until a determination of safety is made.
Prevention is accomplished through a set of seven new rules and upcoming agency guidance documents. In the past manufacturing and distribution agreements would dispose of FDA regulatory requirements with sleight of hand, but requiring practices focused on "prevention" requires a fresh look at policies and procedures and supplier and vendor agreements to ensure upstream and downstream compliance.
The SFT Rule applies to shippers, loaders, receivers, and carriers involved in transportation operations for human and animal food by rail or motor vehicle within the United States. The Rule defines shippers to include freight brokers and shippers have primary responsibility for sanitary conditions unless otherwise assigned by contract. A carrier is a person who physically moves food by rail or motor vehicle but excludes parcel delivery services. The SFT Rule requires carriers to provide training on food-safety and basic sanitary food-transportation practices for their employees, contractors and agents. The term "loader" defines a new category of persons who have responsibility for vehicle inspection before loading and verifying that vehicles and transportation equipment are adequate. The rule requires that receivers to ensure that the food was not subjected to significant temperature abuse during transport.
Responsibility for ensuring that transportation operations are carried out in compliance with the SFT Rule must be assigned to "competent supervisory personnel". The SFT Rule does not specifically address the issue of personal liability for responsible individuals but it should be expected that the FDA will apply its ordinary rules in this regard which impose liability on individuals in position of responsibility for compliance.
A failure to comply with the SFT Rule requirements that causes the food to be "actually unsafe," thereby rendering the food adulterated remains a prohibited act under the Federal Food, Drug, and Cosmetic Act (FDCA). However, an "inconsequential failure" to meet transportation specifications will not create a "per se presumption of adulteration." Nonetheless, if a covered person "becomes aware" or there is evidence of a "material" deviation from the transportation specifications, a "qualified individual" must determine that the food is not unsafe. The failure to take such action may render the food adulterated. The rule does not require actual knowledge of a material deviation.
The SFT Rule sets out equipment, operational, training, and records requirements and the same person may act and be responsible in more than one capacity, and it is now necessary to have policies in place and contractual provisions specifying how the responsibilities under the Rule have been assigned.
The SFT Rule imposes requirements for the design, maintenance, and storage of vehicles and transportation equipment used in transportation operations. The "intended use" of the vehicle will determine the material and workmanship necessary for it to be "suitable." Each participant in the supply chain is responsible and must have procedures in place to ensure compliance.
Operational responsibilities under the SFT Rule include responsibilities for the measures taken during transportation to ensure food safety, such as adequate temperature controls, preventing contamination of ready to eat food from touching raw food, protection of food from contamination by non-food items in the same load or a previous load, and protection of food from cross-contact, such as an unintentional incorporation of a food allergen. All parties should also ensure that their procedures address documentation and records necessary to support their compliance. Contracts should include a mechanism for ensuring others in the supply chain are compliant.
The SFT Rule requires shippers, carriers, loaders, and receivers engaged in transportation operations to maintain records of all written procedures, agreements and training (required of carriers) for 12 months, including any agreement assigning responsibilities under the SFT Rule.
Conclusion
The "science" behind the law's paradigm shift is of dubious validity as the often-cited statistic that 1 in 6 Americans per year contract a foodborne illness fails to exclude consumer handling as a cause. Nonetheless, and irrespective of the true incidence of foodborne illness, a number of high-profile incidents involving serious adverse health outcomes for susceptible populations, including children and the elderly, are perceived by the FDA as providing a sufficient rationale for new regulatory controls. In addition, the food system in the United States is an open system that depends on the integrity of those operating within the supply chain to ensure safety. Congress and the FDA believe they are being forward thinking in working to prevent future outbreaks through the SFT Rule, other recent rules issued under FSMA, and upcoming rules that will address preventing outbreaks caused by the intentional acts of those seeking to contaminate the food supply and causing widespread adverse health outcomes.
Stay tuned for further updates on the additional rules and guidance as well as information concerning enforcement deadlines.
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