Unfinished Business: Answering Your Questions About FSMA's Sanitary Transportation Rule (Part One Of Two)
By Sam Lewis
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: Joel is asking, “What documents and records are required for a facility that only receives and loads both foods that require temperature control and foods that do not require temperature control (not a shipper or carrier)? Is a written procedure or program required?”
Samson: The requirements for a receiver are much more limited than those of a shipper or carrier. The requirements for a receiver of TCS food is to ensure the temperature is, and was maintained, at the proper temperature, ensure the equipment is clean and in proper condition, etc. The non-TCS products depend on what type of product it is. If the product is fully packaged and not TCS, then it is exempt. However, if it is a bulk or not fully packaged, then it will have similar requirements to the TCS products, without the temperature requirement.
Cooper: If you meet the definition of a “receiver” and “loader,” you must retain records of agreements that assign tasks under the rule. As stated in the preamble to the final rule, “…there are no requirements in this rule concerning the retention of individual shipment records… related to truck inspections, or precooling and temperature monitoring activities.” However, a shipper or carrier may choose to retain this information for other business purposes.
Food Online: Jill and Sindhu are asking, “Do the requirements of FSMA’s Sanitary Transportation Rule apply to storage facilities? What do storage facilities need to prepare for?”
Samson: The rule does not address storage facilities, but “warehouses” are addressed in several other sections within FSMA.
Cooper: The rule establishes requirements for shippers, loaders, carriers by motor or rail vehicle, and receivers involved in transporting human and animal food. A storage facility may fall under one or more definitions. Requirements of the Sanitary Transportation rule will also depend on the food the entity is handling.
Food Online: Another question from Sindhu: If a manufacturer sends contract trucks to pick their commodity up from warehouses, who is the shipper?
Samson: Since the definition of a shipper was altered in the final rule to include anyone who “arranges” for the movement of the freight, then in this example, the manufacture would indeed be the shipper and would have to meet those requirements.
Cooper: The shipper is “a person, e.g., the manufacturer or a freight broker, who arranges for the transportation of food in the United States by a carrier or multiple carriers sequentially.”
Food Online: Omar is asking, “If you arrange a shipment using a third-party shipper, are you considered the shipper?” Also, “Can you please clarify the responsibilities of the shipper and carrier? If we arrange a shipment with a carrier, and there happens to be an issue, is the shipper or carrier responsible?”
Samson: Yes. Anyone who arranges for the transport is considered a shipper. Because of this, there can be more than one shipper in certain situations. And, generally, the shipper is going to be liable. However, if there is an issue that arises and it is due to the carrier not following what was set forth in the agreement, then the carrier will be liable.
Cooper: Responsibilities of the shipper include specifying to the carrier, and if necessary, the loader, all necessary sanitary specifications for the carrier’s vehicle and transportation equipment. If the food requires temperature control for safety, the operating temperature, and precooling phase if necessary, must also be specified in writing to the carrier. Additional requirements for shippers can be found in §1.908(b) in the Sanitary Transportation Final Rule. Requirements for carriers will depend upon the written agreement between the carrier and shipper. Additional information specific to responsibilities for carriers can be found in §1.908(e).
Food Online: Another question from Omar: If we are the shipper, do we need to do audits of our carrier to verify compliance?
Samson: There is no requirement within the rule, but it may be a good business practice. This may minimize confusion about complying with the rule, which would benefit both parties and minimize any negative issues.
Cooper: There is no requirement in the rule for a shipper to conduct audits of a carrier.
Food Online: Victor is asking, “If the consignee is managing the transportation service, are they considered to be ‘the shipper’”?
Samson: If they are the one arranging for the freight, then yes.
Cooper: The shipper is “a person, e.g., the manufacturer or a freight broker, who arranges for the transportation of food in the United States by a carrier or multiple carriers sequentially”. Primary responsibility is placed on the shipper to determine appropriate transportation operations, and may rely on contractual agreements to assign some of these responsibilities to other parties.
Food Online: Joshua is asking, “Can the loader and shipper be the same entity? If so, do laws that apply to the shipper and loader now apply to that one entity?”
Samson: Yes, they can be the same entity. However, the loader definition is focused more for when the other entities are not involved in the movement. If the shipper is loading the product, then they would be covered by complying with the shipper’s requirements. However, if a shipper employed loader is offloading product at another stop down the supply chain, then they would now have to meet the loader requirements.
Cooper: Yes, a single entity may be subject to the requirements in multiple capacities, e.g., the loader is also the shipper.
Food Online: Ramakrishna is asking, “How is cross-docking addressed in FSMA’s Sanitary Transportation Rule?”
Samson: There was concern, from a shipper’s standpoint, that they should not be 100 percent liable during a cross-dock movement of products. Since a portion of the products are offloaded and then a separated shipper’s products are loaded, the originating shipper should not be liable for those additional products. This was the exact reason the loader definition was included, as they are the entity directed involved in handling the product and should meet the requirements set forth by the rule.
Cooper: Cross-docking is discussed in the preamble. In response 38, the FDA states, “An entity that only transfers food cargo from one mode of transportation to another, e.g., from a railcar to a truck, would be subject to this rule as a receiver of food arriving by rail vehicle and as a loader of food onto trucks. The entity would not be considered to be a shipper if it simply holds the food pending truck transport and does not arrange for its transport by the trucking firm. The entity may also be subject to other FDA requirements that address the operation of its facility, e.g., the preventive controls rules for human or animal food”. In response 128, FDA addresses less-than-truckload shipments and cross-docking situations, stating, “…the loader, and not the shipper or receiver, is responsible for performing the inspection upon loading as required by § 1.908(c) (1). This requirement would apply to the loader for each sequential loading of a vehicle that makes multiple stops to pick up partial loads. This also applies to the loader for a trans-loading (cross docking) operation.”
Food Online: Michael is asking, “Wording for what is a small business is not clear. What is a small business and when do they need to be compliant?”
Samson: Very small businesses, gross annual revenue of $500,000 averaged out over three years, are exempt. Small businesses, $27,500,000, have one additional year to comply (April 6, 2018).
Cooper: A small business is defined as a business employing fewer than 500 full-time equivalent employees, which is determined by dividing the total number of hours of salary or wages paid directly to employees of the business entity and of all of its affiliates and subsidiaries by the number of hours of work in one year, which is 2,080 hours. For motor vehicle carriers that are not also shippers and/or receivers, this term would mean a business with less than $27,500,000 in annual receipts.
Food Online: Abel is asking, “What is the implementation date of this rule for companies with less than 500 employees?”
Samson: April 6, 2018.
Cooper: Small businesses have until April 6, 2018 for compliance, which is two years from the publication date.
Food Online: Lina is asking, “How does FSMA apply/affect container and port operations and food being shipped in containers for distribution in the U.S.?”
Samson: This has been a difficult question to answer. The rule does not cover air or water transport, so it is not until the container is loaded onto a truck or railcar does the rule now come into place. There is, however, necessary requirements that the foreign shipper needs to meet and satisfy. The requirements of the condition of the container, temperature, cleanliness, etc., lies with the shipper and will most likely stay with the shipper due to the fact the container will most likely not be touched until its final destination. However they will still be impacted
Cooper: Vehicles and transportation equipment used in transportation operations must be designed and maintained to be adequately cleanable to prevent the food they transport from becoming unsafe.
Food Online: Pamela is asking, “How does FSMA’s Sanitary Transportation Rule affect equipment in day-to-day operations? Does it need a sanitation protocol, such as forklifts that run in and out of trailers?”
Samson: You are required to have a procedure for cleaning/sanitizing in place. However, the details of those procedures are up to the shipper. If the products you are shipping contains allergens, then the procedures of cleaning will most likely be stricter. It is also important to note that the fork lift, if involved in loading the trailer, would fall under the “equipment” portion of the rule and would be subject to the cleanliness and condition requirements as well.
Cooper: The process of using forklifts to load and unload trailers would meet the definition of “transportation operations,” and the activities described in the question seem to meet the definition of a “loader.”
Food Online: Ramakrishna has another question: If a container had a load of allergen, for instance roasted peanuts in super sacs, does the cleaning method of the container need to be validated?
Samson: There is not a validation requirement within this rule. However, it is a good practice, especially for potential contamination of allergens. The validation would come with a combination of sanitization and previous loads reported. Within the rail industry, requesting and receiving the previous loads feedback is sometimes very difficult.
Cooper: There is no requirement in the rule for validation of sanitation methods.
Food Online: Songmi is asking, “What happens when the vendor arranges for their own transportation? Where does compliance responsibility lie?”
Samson: The vendor is now acting as the shipper and the responsibility lies with them. They can share some of that responsibility with the carrier if contractually agreed upon, but they will still hold much of that burden. If the carrier is also owned by the vendor (private fleet) then the documented procedures still have to be in place, but they are not required to be as formal.
Cooper: From the question, it seems the vendor would meet the definition of the shipper as the “person, e.g., the manufacturer or a freight broker, who arranges for the transportation of food in the U.S. by a carrier or multiple carriers sequentially.” In addition to the shipper, responsibilities would also be placed on the carrier, loader, and receiver.
Food Online: Nora is asking, “What type of training is required for carrier personnel?
Samson: The training requirement for the rule has been minimized to cover the basics of food safety and an overview of what the rule requires. Any additional information can be requested from the shipper. The FDA plans to offer a free, one-hour training module that would be sufficient in meeting the requirement. However, the program is not mandatory. The carrier can provide their own training or get it from a third-party provider.
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 adequate training to personnel engaged in transportation operations that provides an awareness of potential food safety problems that may occur during food transportation, basic sanitary transportation practices to address those potential problems, and the responsibilities of the carrier under this part. The training must be provided upon hiring and as needed thereafter.
In part two of this series, Cooper and Samson will continue offering their perspective on the unanswered questions from Food For Thought: FSMA’s Sanitary Transportation Rule. Stay tuned