The ST Rule does not provide requirements for products used to clean vehicles/transportation equipment. There are no provisions in the rule that establish requirements for how trucks are to be cleaned/sanitized. FDA has not established SOPs, sanitation guidelines, or requirements for cleaning in the rule. The parameters of the cleaning procedures will be at the shipper’s discretion. We expect that these will be in accord with existing industry best practices. Comment/Response #125 discusses that inspection of vehicle/equipment may be accomplished by any appropriate means, including visual inspection or checking for a wash ticket. The ST rule does not specify any specific measures to determine the sanitary condition of a vehicle/equipment, and has no prescribed criteria to determine the effectiveness of a method. There is no FDA certification or training available at this time pertaining to cleaning trailers.
Under the ST Rule, the shipper would give the carrier information regarding sanitary specifications and cleaning procedures for a vehicle and transportation equipment, per Sec. 1.908(b)(1). The shipper must either
- take measures in accordance with Sec. 1.908 (b)(3) to ensure that vehicles and equipment used in its transportation operations are in appropriate sanitary condition for the transportation of the food, or
- specify to the carrier and, when necessary, the loader, in writing, all necessary sanitary specifications for the carrier’s vehicle and transportation equipment to achieve this purpose, including any specific design specifications and cleaning procedures. The shipper’s specifications must ensure that the vehicle is in appropriate sanitary condition for the transportation of food in order to prevent the food from becoming unsafe during the transportation operation. The information submitted by the shipper is subject to the records requirement in 1.912(a) of the rule. Before loading food not completely enclosed by a container onto a vehicle or into transportation equipment, the loader must determine, considering, as appropriate, specifications provided by the shipper, that the vehicle or transportation equipment is in appropriate sanitary condition for the transport of the food, e.g., it is inadequate physical condition, and free of visible evidence of pest infestation and previous cargo that could cause the food to become unsafe during transportation. This may be accomplished by any appropriate means. The shipper is responsible for communicating to the carrier, or a third-party service provider, the sanitary specifications and cleaning procedures for a vehicle, under Section 1.908(b)(1) of the ST rule.
The shipper may establish a written agreement with the carrier or another party covered by the rule, to implement written procedures specifying how it will ensure that vehicles and equipment used in its transportation operations are in appropriate sanitary condition for the transportation of the food. Please see Comment/Response #16 regarding contractual reassignment of responsibilities under the rule. Please note that if a task under the rule is assigned via contract to a party who is not covered by the rule, FDA would hold the party covered by the rule ultimately responsible for compliance with the provisions of the rule. These written agreements would be subject to record requirements under 1.912.
