Unfinished Business: Answering Your Questions About FSMA's Sanitary Transportation Rule (Part Two Of Two)

By Sam Lewis

Be sure to read Part One of this series

Food Online hosted a live web chat, Food For Thought: FSMA’s Sanitary Transportation Rule featuring Jon Samson, executive director of the Agricultural and Food Transporters Conference at the American Trucking Association; and Samantha Cooper, manager of food safety and quality assurance at GMA. In this 45-minute live Q&A, Samson and Cooper answered the audience’s questions about FSMA’s Sanitary Transportation Rule. While the session was educational and informative, there wasn’t enough time to answer every question. Here, Samson and Cooper address the unanswered questions from the live web chat.

Food Online: Raja is asking, “How does this rule apply to bulk raw commodity, such as wheat?”

Samson: The rule applies similarly to bulk commodities. The same entities are involved and there are similar requirements to be met. The one key component that is of importance here is the request for previous loads and the clean out procedure, especially if dealing with allergens.

Cooper: For food transferred in bulk, the shipper must develop and implement written procedures that adequately ensure previous cargo does not make the food unsafe. If requested by the shipper, the carrier must provide information to the shipper that identifies the previous cargo in the vehicle and/or the most recent cleaning of the bulk vehicle.

Food Online: Leishla is asking, “For frozen product requiring temperature control, what can you recommend for it to be completed? Especially in the case of distributors.”

Samson: Frozen products are actually exempted from the rule. The FDA’s mindset behind the exemption was the fact that if a product that was supposed to be frozen upon delivery and was not, then the product will be instantly rejected on quality reasons before it ever reaches a safety level.

Cooper: Responsibilities of the distributor will depend on how the distributor is subject to the rule, e.g., is the distributor a shipper, loader, carrier, receiver, or a combination. Generally, foods requiring temperature control for safety will have additional requirements related to operating temperature and pre-cooling, if necessary.

Food Online: Leishla would also like to know, “Is enclosed pet food except from rule?”

Samson: As long as it is not temperature controlled for safety, then it is exempt. The main target for the pet food industry was the ingredients going into the making of pet food, including rendered products.

Cooper: Foods that are completely enclosed by a container (and do not require temperature control for safety) are not covered by the rule.

Food Online: Ed is asking, “How will the requirement for temperature control for food safety versus quality be determined? Will the FDA provide a list of commodities that require temperature control for food safety?”

Samson: The FDA will not be providing a list; rather the shipper will have to dictate to the carrier whether the food is TCS or TCQ.

Cooper: I’m not aware of any plans for the FDA providing a list of commodities that would require temperature control for safety. The shipper will need to take into consideration the type of food and its production stage when determining the necessary conditions and controls for the transportation operation.

Food Online: Rose is asking, “I assume each company must determine whether it may be engaged in activities that fall within all roles: shipper, carrier, receiver and loader. Thinking of coffee roasting business — shipment for some incoming goods arranged by broker, but some arranged by coffee company — does the rule contemplate shipments via FedEx/UPS direct to customer?”

Samson: You are correct in your assumption, and the parcel package businesses are exempt. Due to them not knowing with is in the majority of their packages, the FDA chose to not include them in the rule.

Food Online: Joel is asking, “Regarding railcar shippers, how are products impacted that may be shipped by railcar, such as, a refrigerated boxcar for shipping fresh produce packaged for retail? What are the impacts for packaged sugar for retail in a non-refrigerated boxcar regarding the shipper? The rule seems to target foods shipped by trucks. Please clarify.”

Samson: Rail must follow the same requirements as the truck industry. However, the way they go about meeting those requirements is different given the way the industry operates. Since the rail company can simply be the power unit pulling several shippers’ cars, then they operate as the carrier. The shippers must meet the requirements set forth as the products are transported. The majority of the rail impacted is on the bulk commodities industry. And an issue they are having is on the ability to provide the previous loads hauled. So rail is very much involved in the rule, but their ability to meet many of the requirements are complicated due to how their industry operates.

Cooper: The rule establishes requirements for shippers, loaders, carriers by motor or rail vehicle, and receivers involved in transporting human and animal food.

Food Online: Darien is asking, “If there is a situation where product was affected by temperature issues but the shipper, whom is also the receiver, provided temperature tracking equipment that malfunctioned. How would the carrier cover themselves and how would the shipper/receiver cover themselves within these rules?”

Samson: The shipper is liable for the temperature settings and monitoring unless they shift that liability to the carrier. If the liability is shifted to the carrier, they would have to prove that there were no issues with the temperature or prove the temperature was completely run by the shipper/receiver. If the shipper does not transfer liability to the carrier then under the rule he would be liable unless the carrier failed to meet the requirements put forth (faulty equipment or severe temperature fluctuation).

Cooper: If a person subject to this rule becomes aware of an indication of a possible material failure of temperature control or other conditions that may render the food unsafe during transportation, the person must take appropriate action to ensure that the food is not sold or otherwise distributed unless a determination is made by a qualified individual that the temperature deviation or other condition did not render the food unsafe. From the preamble, a qualified individual is described as someone “qualified by training or experience to make such a determination, i.e., he should have a scientific understanding of how the temperature deviation could affect the growth of pathogens or production of toxins in the food.”

Food Online: Gina is asking, “Does the Sanitary Transportation Rule address transporting multiple allergens within one shipment? Or, because product is fully enclosed, is it not a concern unless product is damage?”

Samson: The rule is very vague on this topic, as it is on many others. The products must be transported in a way to prevent cross contamination. If the allergens are completely enclosed, or are segregated another way, where the shipper believes that they will be prevented from contaminating one another, then they will be fine. However, the details and decisions will have to be made by the shipper customer.

Cooper: In the preamble, the FDA notes “facilities that are subject to our cGMP requirements already have similar responsibilities under 21 CFR 117.93. This provision requires that storage and transportation of food must be under conditions that will protect against allergen cross-contact and against biological, chemical (including radiological), and physical contamination of food, as well as against deterioration of the food and the container.”

Before loading food not completely enclosed by a container, the loader must determine, also considering any specifications provided by the shipper, that the vehicle is in appropriate sanitary condition for the transport of food.

Food Online: Arcchana is asking, “For liquid bulk ingredients, such as fats and oils, liquid glucose, and other items not fully enclosed, what requirements of the STHAF will be required to meet with for compliance?”

Samson: With the exception of Grade-A milk, which is waived from the rule, all other liquid bulk ingredients used for human, animal or pet food are required to meet the same requirements. The biggest concern here is the cleanliness of the tanker and the previous loads that were hauled. In the rendering business they have to have procedures to ensure any bacteria growth is dealt with, but the specifics of how to go about doing that are left up the written agreements between the parties.

Cooper: A shipper of food transported in bulk must develop and implement written procedures adequate to ensure that a previous cargo does not make the food unsafe. Measures to ensure the safety of the food may be accomplished by the shipper or by the carrier or another party covered by this rule under a written agreement.

Food Online: Monique is asking, “How does FSMA’s Sanitary Transportation Rule affect the shipment of distillers dried grain (DDG) from plant to farm via a small farm owned truck?”

Samson: Human food byproducts transported directly for animal feed without further processing are exempted from the rule.

Food Online: Zachary is asking, “Let’s assume a shipper has provided cleaning and sanitizing requirements to a carrier. The carrier arrives at the dock to be loaded, but gets denied due to unsanitary conditions. The only option for the carrier is to go get a truck wash at the local wash, but the local truck wash does not offer a service that is equivalent to the shipper's specified cleaning and sanitizing procedure. What should the carrier do?”

Samson: Unfortunately, they must meet the requirements set forth by the shipper or they run the risk of being liable for the product should something happen. In this case the only option would be to converse with the shipper to come up with a modified cleaning schedule or find equipment that meets the shipper’s guidelines. The issue with the vagueness of the rule is the fact that carriers will many times be at the mercy of the shipper and what they are requesting.

Food Online: Liz is asking, “Do trucks operated/driven (fleet vehicles) by shipper employees fall under the sanitary transport rules?”

Samson: They do. There was an effort to exempt intracompany movements in the proposed rule, but it was denied. The FDA wants those companies to follow similar rules, but they are not required to have agreements that are as formal as individual companies.

Food Online: Tom is asking, “FSMA’s Sanitary Transportation Rule sounds a lot like best industry practices and GMPs wrapped up in a GFSI coat where the FDA looks for the presence of a written process exists and has documentation that the process was followed. Any truth to that?”

Samson: That is exactly the end product that the FDA wanted to produce. They do not have the resources or understanding of the transportation industry to alter the current procedures, plus they believed that if it’s not broken then don’t fix it.

Cooper: The Sanitary Transportation of Human and Animal Food rule is part of FDA’s larger effort to focus on prevention of food safety problems throughout the food chain and is part of the implementation of the Sanitary Food Transportation Act of 2005 (2005 SFTA) and the Food Safety Modernization Act of 2011 (FSMA). Lots of flexibility is provided in the rule, which builds on current safe food transportation best practices.

Food Online: Jennifer is asking, “Are carriers required to keep training records for truck drivers carrying food covered under FSMA’s Sanitary Transportation Rule?”

Samson: They are, but the training record can simply be a certificate of completion with the driver’s name and completion date. They are not looking for the specifics of the training, just documentation for completion.

Cooper: When the carrier and shipper have a written agreement that the carrier will be responsible, in whole or in part, for sanitary conditions during transportation operations, the carrier must provide training to personnel that covers awareness of potential food safety problems that may occur, basic sanitary practices to address those problems, and the responsibilities of the carrier under the rule. Training must be provided upon hiring and as needed thereafter, and kept for a period of 12 months beyond when the person identified in the records stops performing the duties for which the training was provided.

Food Online: Christine is seeking additional clarification on the statement made about procedures. Does the shipper need to have copies of the carriers' written procedures?

Samson: No, the shipper is not required to have copies of the carriers’ procedures, only their own. They may request it to ensure the carrier is follow their guidelines, but the STF does not require it. The carrier must have their procedures in place and available to FDA or a shipper customer if requested.

Cooper: The shipper must specify to the carrier and, when necessary, the loader, in writing, all necessary sanitary specifications for the carrier’s vehicle and transportation equipment. Shippers must retain records demonstrating that they provide sanitary specifications and operating temperatures (if needed) to carriers, of any written agreements to have another party implement the written procedures, and the written procedures.