The February 11 posting on this proposed rule (the "Rule") by my partner Mike Walsh in Strasburger's Food & Drug Law Blog (found here) raises several issues requiring detailed attention by motor and rail carriers. These issues go to the Rule's scope and coverage, the specific responsibilities it imposes on carriers, and the extent to which carrier responsibilities can be shifted to shippers (and vice versa) by contract.
Scope: First of all, the Rule extends to food transportation in intrastate as well as interstate commerce, and is broadly preemptive of state law on this subject. In this way, the Rule resembles USDOT regulations on transportation of hazardous materials. Other resemblances between the Rule and the hazmat regulations include emphasis on training of carrier employees, on maintaining a continuous chain of custody for certain food products, and on allocating compliance responsibilities between carriers and shippers.
The Rule, however, defines the terms "shipper" and carrier" without reference to established usage in the transportation industry and USDOT regulations. As a result, it is unclear whether the Rule applies to transportation intermediaries such as brokers and forwarders. It would be advisable for the industry (in comments due May 31, 2014) to educate FDA on the role played by intermediaries in food supply chains. Otherwise, intermediaries may find themselves covered by FDA's mandate for all shippers, carriers and receivers to comply with the Rule. While the FDA is proposing no explicit requirement for a receiver or consignee to reject a non-compliant shipment, it is obvious that the Rule will encourage cargo loss and damage claims by shippers and receivers whenever they reject deliveries due to an arguable violation of the Rules.
The limited extraterritorial scope of the Rule also deserves attention. Shipments transiting the United States between Canada and Mexico (for example) will not be covered, nor will "foreign-to-foreign" segments of cargo movements with ultimate origins or destinations in the United States. The physical transportation of food in a continuous movement across borders to a U.S. destination, however, will be covered by the Rule. Interestingly, the Rule is silent on whether it covers continuous export movements from a U.S. origin.
Carrier Responsibilities: The Agency describes the Rule as being parallel to new regulations it is proposing for reducing contamination risks all along the food supply chain, by mandating good manufacturing practices, hazard analysis and "risk-based preventive controls." The specific requirements for carriers under the Rules, however, do not always flow obviously from those objectives. For example:
(1) Carriers not only must maintain specified sanitary conditions within food-carrying equipment such as trailers; in addition, the equipment itself must be stored at terminals or other facilities meeting sanitation requirements.
(2) Food shippers generally must do a pre-loading inspection of trailers for cleanliness.
(3) For foods requiring temperature controls ("reefer loads"), shippers and carriers generally must "take actions to ensure the maintenance of the transportation cold chain" before loading, through pre-cooling of the trailer by the carrier and verification of the temperature by the shipper.
(4) Food shippers generally must notify carriers in writing of their sanitary requirements for trailers and the temperature requirements for reefer loads.
(5) Food carriers generally must demonstrate "to shippers and, upon request, to receivers" that appropriate temperature controls have been maintained for reefer loads.
(6) Importantly, carriers also must provide food shippers with specified information about "previous cargoes hauled in bulk vehicles offered for the transportation of food and the intervening cleaning of those vehicles."
(7) Food carriers must "develop and implement written procedures ... for cleaning, sanitizing, and inspecting vehicles and transportation equipment."
(8) Food carriers must establish appropriate training for carrier personnel.
(9) Food shippers must keep records of their compliance with (4) above, and food carriers must keep similar records relating to their compliance with (5) through (8) above. Generally these records must be maintained for 12 months, but can be moved to electronic off-site storage after six months if they can be retrieved for FDA review within one business day. (By comparison, USDOT imposes various retention periods depending on the type of record, and allows two business days for retrieval of electronic records. Commenters may want to suggest harmonizing USDOT and FDA requirements in this regard.)
Opportunities for shippers and carriers to re-allocate responsibilities by contract: The Rule increases the importance of carefully drawn shipper-carrier contracts for food transportation. Specific provision is made for shippers and carriers to "mutually agree in writing" that responsibility for compliance with (4), (5) and (6) above will be reassigned to parties other than those specified in the Rule.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
