Delivering Solutions For FSMA's Sanitary Transportation Rule

By Sam Lewis

Be sure to view the entire web chat or read Part One and Part Two of this series

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: We're going to go back over to the sanitation side of this rule. This question's asking: how does the sanitary rule address bulk ingredients shipments regarding sanitation monitoring and previously hauled shipments? We've been noticing suppliers using third-party bulk truck cleaning facilities. Whose responsibility would it be to monitor the sanitation practices at these third-party truck cleaning facilities? Would it be the supplier, or would it be somebody else?

Jon: Samantha already alluded to it, but the three previous loads for, especially for bulk products, sometimes just didn't make sense. If you're hauling barley out of a field all day and you get 20 or 25 loads, it doesn't really make sense to have to have those three previous loads. But, if you're hauling an allergen — and we ran into this problem, peanuts — and then you turn around and haul flour, you could end up having some peanut in their flour.

As far as who is liable for that, it’s the shipper. If they are concerned about what was previously in that trailer or any sort of sanitization practices, they're liable for telling the carrier what they want. If you want to see what was previously loaded in that trailer or in that car, then you've got to request that. "I want the last 10 loads or the last two loads to figure out what's in there."

As far as the sanitization goes, it is, again, the shipper's responsibility to clearly spell out to the carrier, "This is what I want you to do as far as cleaning and sanitizing." It's also the shipper's responsibility to visually inspect to see if that trailer is indeed cleaned and sanitized to their specifications. Now, if the shipper has done all of that and the carrier still does not properly follow those requirements, then the liability is now shifted over to the carrier. Now, the carrier, if something goes wrong, then they're most likely the liable party.

Sam: Excellent. I'm going to go a little bit deeper into that sanitation question. This one came in, and Samantha, you can address this. It says: despite our containers being imported on a ship from Latin America, won't the FDA still want to know how we know those containers were cleaned before we loaded the product?

Samantha: This information would probably be communicated, I think, outside of this rule as well. You still have to remember that all food that will be destined for consumption in the U.S. still remains subject to the adulteration provision of the FD&C Act. Regardless if it originates in a foreign country, you still can't sell and ship adulterated food. It still has to be in a safe, in a cleanable, or adequately cleanable container.

As far as the FDA wanting to make sure, just going back, again, to the record keeping, this type of rule is not going to be the FDA coming and asking for all of your documentation of, "Well, did you make sure this, this, this?" It's going to be procedures.

Yes, the food should be packed in a clean container before, but just for the instance of this rule, it's outside of this rule on a foreign leg. The rule only really comes to effect on U.S. soil. I know there is some concern that I've heard, "What if you don't have contact with the foreign shipper?" Again, the FDA addresses in the preamble, but they said, you know, the shipper would be working possibly with a U.S. broker, so that U.S. broker could be contacted and placed, and they would be able to evaluate whether the food is unsafe. If it's like a food that needs temperature control for food safety and they need to contact someone, they would have a contact point somewhere in the U.S.

Sam: Thank you for that, Samantha. We're going to go back to a compliance issue. This question came in, and it says: talking about the FDA being flexible, under what conditions would the FDA waive some of the requirements of the rule?

Samantha: I don't think FDA would waive the rule. We talked about some of the exemptions of the rule, but maybe that's what the question's applying to. So, who's not subject to the rule? There are some exemptions of, like we said before, of foods fully enclosed by a container that don't need temperature control for food safety. They would be kind of waived, or they wouldn't be under the rule. Also, if the shipper, carrier, receiver, or loader falls underneath the farm definition, which is actually the same definition any other, that falls under the Preventive Controls Rule. If those activities fall within the farm definition, that is outside of the rule, as well.

Also, if you're a facility that's engaged solely in USDA, so if you're purely in meat or purely a process egg facility, the rule would be out of scope at the facility. However, once it does leave the facility, it kind of comes underneath this umbrella, and there are different obligations.

Jon: In addition to the exemptions, there is a waiver process where you can actually be waived completely. There are two waivers currently; one of them is for Grade A milk. That's because they've got a process in place that far exceeds what the FDA is trying to do here. Then the other one is for deliveries directly to the consumer, so your Peapod grocery store, your restaurant deliveries. Those sectors have been waived from the rule.

As far as being waived from specific requirements, we haven't really seen anything like that. When you get down to enforcement, again, those that have had very close conversations with the FDA know that the FDA really doesn't want anything to do with this transportation section. It was mandated to them in 2005. They issued guidance, which wasn't enforceable, and then this was kind of Congress's way of saying, "We asked you to do this before. You didn't really do anything, so we're going to ask you to do it again to make sure we close that loophole within the supply chain." Even though this is part of the rule, we don't see strict enforcement unless something goes wrong further up the supply chain. We don't really anticipate them knocking on carriers' doors.

What we do anticipate could happen is if something went wrong at the manufacturer or the shipper and somebody got sick at the end user, that they start to look down that supply chain, including the people that come under the Sanitary Transportation Rule, and then start looking closer at them if something goes wrong.

We're just not anticipating really active enforcement if nothing's really going on within the industry, and that goes back to the FDA really basing these on the best practices. Because, at the end of the day, they really do understand and believe, as far as the products being transported, they're being done very safely and efficiently. They don't really want to upset the apple cart there.

Sam: I've another question for you, Jon. This one relates to shipping operations. How do distribution centers need to handle trucks that make multiple stops on a daily route?

Jon: This one's been kind of tough. This has been kind of a gray area, understanding that if you're popping the back of the truck 20 times during one outing, you're going to have some pretty large temperature fluctuation. As long as they're able to understand that and kind of build that into the agreement, and make sure that all the products being moved around are being done so as safely and efficiently as possible.

Now, going back to the initial rule again, the way it was written, if a carrier had a contract in with the shipper, and the shipper said, "You've got to haul this product at this temperature," and that temperature went outside of what was put in the contract, then that food was going to automatically be deemed adulterated, or could be.

Something like that for a multiple-stop carrier would have been disastrous considering the temperature fluctuations. Luckily, they pared that back, and that's no longer the case. It really comes down to the shipper understanding what needs to happen to his product to make sure it gets from point A to B, C, D, and E. They've got to convey that to the carrier. That has been a very big gray area as far as how they're going to do that. I think we'll kind of find out over the next couple months when this stuff all goes into effect how they're going to deal with that, but I don't anticipate there being any issues as far as them getting in trouble because of those multiple stops.

Samantha: Affirmative. This is heavily commented on in the proposed rule, so a lot of comments on like less than load shipments. Under the final rule, the loader would also be responsible for making sure that the vehicle is in sanitary conditions, appropriate for transporting the food. Between stops, it would be also responsibility on the loader, as well.

Sam: Excellent. Thank you, guys. We have time for just one more question. I think this one could be straightforward or it could be very tangled. The question says: should the agreement between the common carrier and the shipper requirements be a legal agreement, meaning written by an attorney or a legal counselor, or just a signed form with the requirements is enough?

Jon: Samantha can correct me if I'm wrong, but I believe it can be bill of lading. It could be a contractual agreement. They really only specified that it needs to be written. Besides that, I don't believe they go into the legal document side. I think it just has to be more than a handshake, and it's got to be a written document. Samantha, maybe you can touch more on that.

Samantha: I don't believe there's a requirement for a contract. They kind of say it's a one-time notification, but they don't say that it has to be a legal document. I know I've heard some kind of rumblings around the community that a lot of times if the shipper is having a legal contract, right now, some of the carriers don’t want to sign that type of document. I know there are still a lot of questions as people work through this rule how to have that written communication.

Sam: There certainly is a lot of think about with this rule and FSMA's other rules, as well. Unfortunately, we've run out of time. If we didn't have a chance to answer your question, we'll certainly do our best to address it in follow-up content to this session. Be on the lookout for an unfinished business Q&A. It'll be on Food Online in the near future. Jon and Samantha will be taking the questions that you guys submitted and answering them. It might end up being a two-part series because we do have a lot to cover.

 If you or anyone you know would like to view today's web chat, or if you'd like to access it again, it will be made available soon on FoodOnline.com.

For more information on GMA and today's topic, as well as becoming a GMA member, please visit gmaonline.org. The American Trucking Association also has some great content on their site. You can find news and events at trucking.org. Last, but certainly not least, be sure to visit Food Online and our FSMA FDA Regulatory Solutions Center for thought leadership content on FSMA compliance. Jon, did you have any closing thoughts for us?

Jon: First of all, I'd like to thank everybody for being on the web chat, and simply state — this is something we've been harping on carriers for years — since there is so much ambiguity within the rule and so many gray areas that still need to be addressed, we've been asking them and asking shippers as well, please go out there. Please communicate. Please figure out the best way to move forward. That's going to eliminate a lot of confusion. It'll also eliminate the carrier potentially just being dictated to that these are the new contract requirements, and this is what you have going forward.

We've been asking them to minimize any sort of negative interruptions, to go out there and have that conversation. Everybody get on the same page and understand what these new requirements are going to do. Besides that, I'd like to say thank you to Food Online and thank GMA for the opportunity to be here, and I truly appreciate everybody's participation today.

Samantha: Thank you again for having us. It was really great to be involved with this, and it was great to hear Jon's responses as well. Thank you, everyone, for the questions. Again, FDA has a long-going mantra of educating while enduring to regulate. I think we're going to continue to see that from the FDA.

Sam: Well, thank you both. We truly appreciate taking time from your busy schedule to educate the audience and provide some answers to pressing questions, and hopefully some actionable takeaways for our attendees. With that, our time together has come to an end. Again, thank you both for everything you do. Thank you, attendees, for taking the time to join us. We hope you enjoy the rest of your day.