Our Life Sciences Blog continues to follow the FDA’s implementation of the Food Safety and Modernization Act. Check out all of the recent developments here and here.
The latest installment of our series discusses the FDA’s new Sanitary Transport Rule.
The Sanitary Transport Rule is different from the others passed so far under the FSMA, as it is not focused on the manufacturing, packing, growing, labeling or other aspects of food creation. Rather, it is focused on ensuring that food and food ingredients are properly transported “from farm to table” to ensure that contamination and adulteration are avoided en route and applies to both human and animal food.
What’s the scope of the Sanitary Transportation Rule?
The new Rule applies to entities that are engaged in the shipping, receiving, loading and carrying of food as defined under 21 U.S.C. §321(f) in the Food, Drug and Cosmetics Act. Loading and loaders are a new category found in the final Rule. This Rule does include exemptions for small businesses (less than $500,000 in annual revenue), foods which are simply passing through the U.S. en route to foreign countries (also known as “transshipping”), and food in facilities that only handle food regulated by the USDA. Transportation activities conducted by farms are not covered by the Rule, although consideration by the FDA is underway for a companion rule outlining what it considers to be good farm practices. These exemptions apply only to the requirements of the Sanitary Food Transport Rule and do not exempt these entities from other transportation sanitation requirements under other regulations.
Furthermore, the Rule explicitly states that the new regulations apply in addition to any other transportation requirements, and do not supplant them, including the new cGMPs and HARPC requirements in 21 C.F.R. §117 (human foods) and §507 (animal feeds), the regulations covering the handling of eggs in 21 C.F.R. § 118, and the cGMPs for medicated feeds under 21 C.F.R. §225. Finally, the Rule states that any food that is not transported in a manner compliant with the Sanitary Transport Rule may be deemed adulterated under 21 U.S.C. §342.
To whom does the Sanitary Transportation Rule apply?
The Rule is expansive and serves to include a large segment of the transportation market and the most common shipping methods in the U.S. A handful of definitions in 21 C.F.R. §1905 provide the scope of the Rule:
- Bulk vehicle means a tank truck, hopper truck, rail tank car, hopper car, cargo tank, portable tank, freight container, or hopper bin, or any other vehicle in which food is shipped in bulk, with the food coming into direct contact with the vehicle.
- Carrier means a person who physically moves food by rail or motor vehicle in commerce within the U.S. The term carrier does not include any person who transports food while operating as a parcel delivery service.
- Transportation means any movement of food by motor vehicle or rail vehicle in commerce within the U.S.
- Transportation equipment means equipment used in food transportation operations, e.g., bulk and non-bulk containers, bins, totes, pallets, pumps, fittings, hoses, gaskets, loading systems, and unloading systems. Transportation equipment also includes a railcar not attached to a locomotive or a trailer not attached to a tractor.
It is clear that foods transported in the U.S. using any “motor vehicle or rail vehicle” are covered by the new Rule. However, conspicuously absent from any of the regulations is any mention of aircraft, ships, barges or boats. While commonly used intermodal shipping containers are arguably included under the definition of “bulk container,” (unless on a waterway) these containers are often moved from rail to container ships and back to rails or onto trucks. Although the Rule does not cover certain forms of intermodal shipping, what is clear is that once the intact bulk container is moved onto a motor or rail vehicle for transportation within the U.S., that container and its loading and off-loading comes within the scope of this Rule.
Barges used to ship grains and other products also appear to avoid coverage under the Rule. This is echoed in the FDA’s comments in the Federal Register Notice. In Response 40, the FDA responded to a question regarding the responsibilities of loaders of vessels meant for export over the ocean. The FDA responded in relevant part:
Further, the statute defines “transportation” as any movement in commerce by motor vehicle or rail vehicle. Thus, persons engaged in the transportation of food that is intended for export are subject to all applicable requirements of this Rule when the food is in transit by motor vehicle or rail vehicle to the land-based U.S. border point of export or a port facility.... The loader for the trans-oceanic ship transport segment is not subject to the Rule because the Rule does not cover transportation operations for water borne transportation.
The reason for this distinction between covered rail and road-covered vehicles, and uncovered boats and aircraft transportation, is the SFTA, passed in 2005. The SFTA, as mentioned in the FDA’s Response 40 and echoed in responses to several other comments during the rulemaking process, sufficiently limits the transportation that is covered by the law. Specifically, the FDA stated:
The 2005 SFTA, as passed by Congress ... expressly mandates that FDA issue regulations to “require 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 the food adulterated” (21 U.S.C. 350e(b)).... The 2005 SFTA does not mandate that we issue regulations applicable to the sanitary transportation of food by any other conveyances, including barges or ships and aircraft. However, if we find that there is a public health need for us to regulate air and barge or ship transportation, we will consider whether we want to pursue covering these routes under a non-SFTA authority in the future.
As a result, the Sanitary Transport Rule does not generally apply to food products while they are being transported by air or water.
Are there new requirements for transportation equipment?
The new Rule requires equipment used in transportation (trucks, containers, tanks, etc) to be adequate for its intended uses, specifically considering the types of food products that will be transported. Under the Rule, this equipment must be:
- Adequately cleanable to prevent allergen cross-contact and contamination between loads
- Adequately maintained
- Able to properly manage temperature for shipments that require temperature control
- Stored in a manner to prevent contamination by pests or other materials
Although it would be expected with the implementation of the HARPC rules that these covered activities are already in place, the Rule now clearly makes these activities required activities regardless of the applicability of HARPC. Further, it is well worth noting that the FDA intends to work with the Department of Transportation to develop procedures for safety inspections designed to identify contamination or adulteration of food products in transit.
How do covered entities respond to suspected contamination or adulteration of food during transport?
Under 21 C.F.R. § 1.908(6), if a company involved in the transportation of food products detects or suspects possible contamination, the Rule establishes procedures to be followed. These possible contamination situations which require action include (1) failure to adequately clean the transport container, (2) cross-contamination, (3) a possible material failure of temperature controls, or (4) other conditions that may render the food unsafe during transportation. When these conditions are suspected, the covered transport entity must take all appropriate steps to ensure that the food is not sold or otherwise distributed until a qualified individual makes a determination that the suspected failure did not render the food unsafe. These covered entities will need to have in place written corrective action plans which include FDA-mandated actions, such as reporting to the reportable food registry, as well as corrective actions including, but not limited to, ensuring that the food is not used or sold, possible market withdrawal or recall.
Shippers are required to supply to the transporter, in writing, shipping conditions that ensure safe transport of the food. If these conditions vary per load, these conditions must be provided before each shipment.
What records-keeping responsibilities does the new Rule impose?
Under 21 C.F.R. § 1.912, each entity in the chain of transportation has specific records-keeping requirements. Some entities involved with multiple steps of the transportation process (manufacturers that act as shippers, loaders and carriers, for example) must complete all requirements relevant to the steps in which they are involved. Some examples of these records- keeping requirements are:
- Shippers must retain records that demonstrate they provided specifications and written agreements under 21 C.F.R. § 1.908(b) for 12 months after they were in use.
- Carriers must retain records of the specifications received from shippers under 21 C.F.R. § 1.908 for 12 months after they were in use. Carriers must also keep records of all training of employees as required by 21 C.F.R. § 1.908 for 12 months after any trained employee ceases performing the procedures that were the subject of the training.
- Electronic storage of records is allowed. Also, off-site storage of some records is also allowed if they can be retrieved within 24 hours.
It is important to note that these records-keeping requirements are in addition to requirements already under other applicable federal or state requirements.
Are waivers available for the requirements of the Sanitary Transport Rule?
Yes, under 21 C.F.R. § 1.914, the FDA allows entities to submit citizen petitions to request a waiver of the requirements set forth under this new Rule. Waivers may be granted if the granting does not result in a risk to the safety of the food being transported and is not contrary to public policy. However, it is expected that waivers will be difficult to obtain in light of the concern for ensuring a safe food supply.