Food For Thought: FSMA's Sanitary Transportation Rule

By Sam Lewis

Be sure to view the entire web chat

On Tuesday, March 14, GMA and ATA partnered with Food Online for a live web chat, Food For Thought: FSMA’s Sanitary Transportation Rule. In this 45-minute live Q&A, Jon Samson, Executive Director of AFTC at ATA and Samantha Cooper, manager of Food Safety and Quality Assurance at GMA joined Food Online’s editor, Sam Lewis, to answer the food industry’s questions on the topic.

Sam: Hello, everyone, and thank you for attending today's web chat. I'd like to thank GMA and ATA, for partnering with Food Online and providing us with excellent subject matter experts on this important and timely topic. And thank you, attendees, for joining us.

It's my pleasure to introduce to you our subject matter experts. We have Jon Samson, Executive Director of AFTC at ATA. We also have Samantha Cooper, Manager of Food Safety and Quality Assurance at GMA.

Jon holds a master's degree in public policy from George Mason University and has been in his current role as executive director of AFTC at ATA since 2011. Prior to his current role, he served as director of public policy for Agricultural Retailers Association, where he was responsible for lobbying on policy issues impacting agricultural retailers and distributors. Jon, thanks for taking the time to join us on Food for Thought.

Jon: Thanks, Sam. I am happy to be here.

Sam: We also have GMA's manager of Food Safety and Quality Assurance, Samantha Cooper, with us. In this capacity, she works with some of the world's largest food companies to identify, develop, and recommend solutions to ongoing and emergent scientific, regulatory, and public policy issues affecting the food industry. Samantha is an International HACCP Alliance lead instructor, an FSPCA human food lead instructor, and an FSPCA Foreign Supplier Verification Programs lead instructor. Prior to GMA, Ms. Cooper gained experience as a food safety manager at a sous vide manufacturer and completed a management training program at a poultry processing facility. Samantha, it's a pleasure to have you with us.

Samantha: I am happy to be here today.

Sam: Here's what we have in store for you: Our goal is to provide you with knowledge and industry-leading practices food and beverage manufacturers should employ to comply with FSMA's Sanitary Transportation Rule. Most importantly, we'll spend much of our time addressing and answering your questions. Again, feel free to submit them at any point during our chat.

Let's get started. Samantha, can you give us a broad view of today's topic, its importance, and some of the challenges the industry is facing within it?

Samantha: Sure. Today, we're going to cover FSMA's Sanitary Transportation Rule. The overall goal of this rule is to prevent practices during transportation that create food safety risks, such as failure to properly refrigerate food, inadequate cleaning of vehicles between loads, and failure to properly protect food.

The rule establishes several key requirements for vehicle and transportation equipment, transportation operations, training, and then record keeping requirements. The rule also establishes requirements for shippers, loaders, carriers by motor or rail, and receivers involved in transporting human and animal food to use sanitary practices to ensure the safety of that food. Just a key note as we go through today's Q&A that these requirements do not apply to transportation by ship or air. The rule is also flexible in nature, so it allows the transportation industry to continue to use industry best practices.

Sam: Excellent. Well, we appreciate your introduction. Jon, do you have anything to add to Samantha's points?

Jon: To follow up, especially on the last point about the rule being flexible to allow kind of that best industry practices to continue, I think it's important to note that during the proposed rule process, even though the FDA wanted to focus on the best practices, what they actually proposed didn't quite exactly line up with that. With the help of GMA and several other industry-related associations, we were able to educate the FDA on the specifics of the transportation industry. It really did, by the time we saw the final rule, come back and match up with those industry best practices.

I think it's also important to note that because we are transporting a food product, something that could easily become unsafe or adulterated depending on how it's transported. The FDA also understood that. They really turned the liability towards the shipper, believing and understanding that the shipper knows that food product the best. Even though this is a transportation-related rule, the liability really lays on the shipper, and then it's his job to a contract, set the requirements, and it then it’s the carrier's responsibility to follow what's in that contract. I think that's an important distinction that we need to set as a base as we move forward.

Sam: Thank you both for your insights and getting our chat off to a great start. Questions have been pouring in from our audience and we would like to begin addressing them. We'll try to answer as many questions as possible in the time we have remaining. If you haven't yet, please feel free to submit a question.

Jon, in your points about the rule, you mentioned some key terms. One of our questions actually was about that. This person was seeking clarification on the terms used throughout the rule, such as: loader, shipper, receiver, etc. Could you highlight some of those key definitions and let us know what they mean and who they apply to?

Jon: Sure. This was part of some of the larger changes that were made from the proposed rule to the final rule. First, on the shipper's side, the shipper, under the definition of the final rule, is now someone who arranges for the freight of that transportation. That's a big change from the original definition because it brings in that third party, that brokerage industry, as well. Throughout this entire rule, they really want to keep track of where the food is, and from its entire supply chain movement. They were wondering, “If the shipper is brokering out loads, how do we keep track of those brokered loads?” The only way to really fully do that is bring the broker underneath in the shipper definition.

The requirements, a lot of the requirements, not all of them, but the requirements that are required of the shipper also have to be followed by the broker in order to make sure that if the shipper's not directly working with those carriers, there's some sort of a connection there. That, first and foremost, was a pretty large change in the definition.

The carrier, of course, they pretty much made it clear that it's the person that's transporting the product. There's no surprise there.

Then there's the receiver, of course, the person that receives the product at the endpoint. Which, again, this is not really any surprise from the final rule.

The one addition that was made was the addition of the loader, and so the person that's actually loading and unloading the vehicle.

Really, their goal here by adding the definition of the loader was: if you have a less than truckload (LTL) carrier, and they have a shipper customer, and you end up at a cross-stop facility, if they're off-loading part of that trailer and then on-loading an additional product from a different shipper, there's no way for that originating shipper to understand that new product that's being put on there. The liability shouldn't be there for the originating shipper.

Now the loader is required to make sure that the trailer's clean when he's loading the new product, make sure that the equipment's running properly, and go through the checks of the rules, make sure that it meets the requirements moving forward. As far as definitions go, those are kind of the main pieces of the people that are going to be impacted by the rule.

Samantha: I would add a point to the loader, as well. The loader also has responsibility, if the food is required temperature control for safety, the loader would then also make sure that the temperature of the trailer was appropriate, or pre-cooled if that was identified.

Sam: Excellent. I'm going to piggyback on one of Jon's points for our next question. This person was asking, “What would you recommend for a cleaning or a sanitation process? Would it be chemicals? Would it be more of an overall sanitation program or process?” What is the best approach for that? So, Samantha, if you want to take that one, and Jon, you can follow up with any additional points.

Samantha: Like Jon had mentioned, the definition of shipper, the shipper is going to make the basic, kind of an SOP for the carrier. The shipper is going to be the one identifying what those standards are for cleaning. I can't make any suggestions for how to clean, but it should be adequate to protect the food from any sanitary issues and not to make the food harmful.

Jon: One thing that we have been a little watchful of, when the shipper, since they are going to be cleaning their own facilities, we want to make sure the carrier's communicating with the shipper because, again, the shipper is putting those processes in place. We want to make sure that the shipper understands that perhaps what's being used to clean their warehouses or their manufacturing floor probably is not going to work for the inside of a trailer. We want to make sure that when the shipper is sending those standards to the carrier, that those products are actually going to be adequate to properly clean and not end up negatively impacting the equipment that the carrier has.

For example, we were talking with the Renderers Association and they get a significant amount of potential listeria and salmonella backup from their rendered products. When they clean it out, they want to make sure right now that whatever they're using to clean that out properly kills the bacteria that has, or potentially has, built up. They're doing research right now within their rendering community to be able to present that to the shipper. I think that's a big point to understand, that even though the shipper's dictating a lot of this stuff, they may not have a full understanding of what kind of products, what kind of equipment the carrier has, and to make sure that that communication is done properly.

Sam: That was a pretty detailed explanation, Jon. Thank you. We do have a lot of different areas to cover within this rule, so I'm going to kind of jump around from topic to topic.

This next question has to do with temperature monitoring. Bridgette is asking, “What kind of temperature monitoring systems or actions are required as part of the Sanitary Transportation Rule? Is it enough for a company's delivery truck or warehouse-to-shelf driver to record the temperature of a product in the trailer before and after delivery using a digital thermometer? If so, should these thermometers be calibrated daily, or is it a continuous temperature monitoring process?” Jon, if you could address that one, and Samantha, if you could follow up, that'd be great.

Jon: You'll probably get this answer to a lot of these questions, and Samantha alluded to this during the last question, none of that is specific within the rule. The Sanitary Transportation Rule is extraordinarily ambiguous and lacks a lot of specifics. All of those details are going to be left up to the shipper: the actual technology that's needed, how often the temperatures are going to be monitored, whether those temperatures are going to have to be provided, or if they're only provided if something goes wrong.

I know we do have some carrier customers, or some of our carriers' customers want to see that temperature recording every single time that they deliver the product. There are plenty of other ones, they won't ask for that unless there's an actually a problem, an issue somewhere.

The same thing goes for technology. Some of them require and want the highest grade telematics system in their so they can see them constantly monitoring the temperatures, and some of them just want the ambient air temperature within the trailer. It really, again, comes down to what's going to be listed out in the contract.

Samantha: Yeah, that's a good point. Like Jon said, this rule is very flexible. In the final rule, there is no requirement for temperature controls unless you need temperature control for food safety. Even if you have a refrigerated or frozen product, if it does not require temperature control for safety, then it's not required by the rule.

Then for calibration, there's no requirement, but it should be industry best practice. If you're going to use a thermometer, it should be calibrated, but there's no timeframe requirement for calibration.

Sam: Thank you, guys. To sort of go from one topic to the other, can we address a few compliance issues? Ricardo is asking, “How does the Sanitary Transportation Rule affect the bakery section where there is a low-risk items, such as donuts to sell in an open case, or packed cookies? Samantha, if you could handle that, and Jon add some additional thoughts.

Samantha: I'm going to make the assumption the donut or the cookie is completely enclosed by a container, and it doesn't, again, require temperature control for food safety, then that product is actually exempt from the rule. You wouldn't be covered under the Sanitary Transport Rule.

However, you would still be under the FD&C Act, so you'd still have to be knowledgeable of the adulteration provisions. You still would have to protect the food from being adulterated or becoming putrid or dirty. As far as a donut or a bakery item goes, if it's completely enclosed, then you'd be excluded from the rule.

Jon: I've got nothing to add from Samantha's comments, they were spot on. The only thing I would add that the products, the ingredients that are coming in to make those products, if they are being made in-house, a lot of those, especially if they are bulk product and not completely enclosed, are going to be subject to the rule as well. Potentially, your big bags of flour and a lot of the other ingredients that go into the baking could fall under the rule depending on how they're being transported, as well.

In Part Two of this series, Jon and Samantha will continue to answer questions from the web chat’s live audience. Stay tuned.