The U.S. Food and Drug Administration’s (FDA’s) final rule for the Sanitary Transportation of Human and Animal Food (the “Sanitary Transportation Rule” or “Rule”), is broad in its coverage.
It is a “food” rule, not just a fresh produce rule. Food products as diverse as poultry, frozen dinners, juice transported in a tanker car, and fresh produce are subject to the Rule. It is no surprise then, that rather than prescribing specific operating procedures to be followed, responsibility for the development of procedures is generally left to shippers (which includes any firm that arranges for the transportation of food, including truck brokers), as well as loaders, carriers, and receivers (for full definitions, see below) and allows these parties to agree to ‘reassign’ these responsibilities among themselves.
As such, the Rule has produce professionals rethinking their transportation procedures; specifically, how to best comply with these new requirements with the overarching goal of preventing food from becoming unsafe during transportation operations.
In this article we highlight some of the Rule’s requirements that are most relevant to produce professionals shipping by motor carriage, and discuss some potential approaches to compliance.
Does the Rule Apply to Me? And if so, when? All companies, other than very small businesses (i.e., those with revenue under $500,000 per year), are required to meet the Rule’s basic requirements and implementation dates for companies defined by the Rule as small businesses are fast approaching. Carriers with less than $27 million in annual revenue, and all other businesses employing fewer than 500 full-time equivalent employees, are required to comply with the Rule by April 6, 2018, while larger companies have been subject to the rule since April 6, 2017.
A nice thing about this Rule is that the required practices are consistent with industry best practices for marketability as well as food safety. “If your company is involved in the produce supply chain, I believe you should operate as if the Rule applies to you,” asserts Jimmy DeMatteis, president and CEO of DMTB in Des Moines, IA. “The Rule seems much more complex than it really is.”
Shippers, Loaders, Carriers & Receivers Three fundamental requirements apply to every entity subject to the Rule: first, Section 1.908(a)(2) of the Rule requires that responsibility for ensuring transportation operations comply with the Rule be assigned to “competent supervisory personnel.”
Accordingly, all firms subject to the Rule—whether as shippers, loaders, carriers, or receivers—should be prepared to show the FDA that someone within the organization has been given responsibility for compliance with the Rule.
The U.S. Food and Drug Administration’s (FDA’s) final rule for the Sanitary Transportation of Human and Animal Food (the “Sanitary Transportation Rule” or “Rule”), is broad in its coverage.
It is a “food” rule, not just a fresh produce rule. Food products as diverse as poultry, frozen dinners, juice transported in a tanker car, and fresh produce are subject to the Rule. It is no surprise then, that rather than prescribing specific operating procedures to be followed, responsibility for the development of procedures is generally left to shippers (which includes any firm that arranges for the transportation of food, including truck brokers), as well as loaders, carriers, and receivers (for full definitions, see below) and allows these parties to agree to ‘reassign’ these responsibilities among themselves.
As such, the Rule has produce professionals rethinking their transportation procedures; specifically, how to best comply with these new requirements with the overarching goal of preventing food from becoming unsafe during transportation operations.
In this article we highlight some of the Rule’s requirements that are most relevant to produce professionals shipping by motor carriage, and discuss some potential approaches to compliance.
Does the Rule Apply to Me? And if so, when? All companies, other than very small businesses (i.e., those with revenue under $500,000 per year), are required to meet the Rule’s basic requirements and implementation dates for companies defined by the Rule as small businesses are fast approaching. Carriers with less than $27 million in annual revenue, and all other businesses employing fewer than 500 full-time equivalent employees, are required to comply with the Rule by April 6, 2018, while larger companies have been subject to the rule since April 6, 2017.
A nice thing about this Rule is that the required practices are consistent with industry best practices for marketability as well as food safety. “If your company is involved in the produce supply chain, I believe you should operate as if the Rule applies to you,” asserts Jimmy DeMatteis, president and CEO of DMTB in Des Moines, IA. “The Rule seems much more complex than it really is.”
Shippers, Loaders, Carriers & Receivers Three fundamental requirements apply to every entity subject to the Rule: first, Section 1.908(a)(2) of the Rule requires that responsibility for ensuring transportation operations comply with the Rule be assigned to “competent supervisory personnel.”
Accordingly, all firms subject to the Rule—whether as shippers, loaders, carriers, or receivers—should be prepared to show the FDA that someone within the organization has been given responsibility for compliance with the Rule.
The organization should also be prepared to demonstrate that not only has the responsibility been assigned, but that the individual or individuals have in fact acted in this role on behalf of the company.
Second, Section 1.908 (a)(6) of the Rule requires that every entity subject to the Rule respond appropriately after becoming aware of a food safety issue. This provision provides –
If a shipper, loader, carrier, or receiver 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 food shall not be sold or otherwise distributed, and these persons must take appropriate action including, as necessary, communication with other parties 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.
The application of this provision is perhaps best illustrated with a nonproduce example. Imagine a shipper, carrier, or receiver discovers that a shipment of frozen dinners has thawed during a cross-country trip. This provision makes it illegal for the driver or receiving personnel, for example, to simply refreeze and distribute the product without the approval of a “qualified individual.”
Chris Burroughs, senior director for government affairs for the Alexandria, VA-based Transportation Intermediaries Association or TIA, explains that the “term ‘qualified individual’ was not used in the proposed rule of the Sanitary Transportation of Food, but was used in the Final Rule.”
For a definition of this term (which does not appear in the Sanitary Transportation Rule) both Burroughs and John Husk, a partner at the law firm Seaton & Husk, LP in Vienna, VA, look to a separate rule, the Preventive Controls for Human and Animal Food Rule, which like the Sanitary Trans-portation Rule was promulgated under the Food Safety Modernization Act (FSMA), and defines a “preventative controls qualified individual” as “a qualified individual who has successfully completed certain training in the development and application of risk-based preventative controls or is otherwise qualified through job experience to develop and apply a food safety system.”
Burroughs adds, “The Sanitary Trans-portation of Food final rule does not set training requirements or standards for shippers (brokers), so one can only assume that a qualified individual is someone who has the necessary job experience to ensure the sanitary condition of the food product.”
And while food safety issues resulting from temperature abuse may by more obvious with frozen dinners and meat products than fresh produce, the FDA’s training materials suggest they are viewing temperature abuse affecting fresh-cut product to be a food safety issue, and not just a spoilage issue outside the purview of the Rule.
As a practical matter, however, it may make sense to have a qualified individual review all instances of temperature abuse or other “material failures” (e.g., shifting in transit where produce comes loose from shipping containers and comes into contact with the floor and/or walls of the trailer) to decide if food safety concerns preclude the sale or distribution of the product.
Just what constitutes temperature abuse or a material failure that poses a threat to food safety is not specifically defined by the Rule, and it is therefore left for the company and its qualified individual(s) to decide on a case-by-case basis. Of course, if people become ill as a result of the incident, qualified individuals can expect their decision-making process to come under FDA scrutiny.
The third fundamental requirement applicable to every entity subject to the Rule is recordkeeping. Section 1.912 specifies what records should be maintained under the Rule. Suffice it to say, all documentation generated in compliance with this Rule must be retained for a period of twelve (12) months after the documentation is no longer in use.
Similarly, documentation of training (applicable to carrier personnel) must be retained for a period of twelve (12) months after the individual “stops performing the duties for which the training was provided.” Husk cautions against oversimplifying this requirement: “It’s sometimes referred to as a ‘twelve (12) month requirement,’ but this could be misleading because, in most cases, you’ll need to retain the documentation much longer.”
DeMatteis summarizes the Rule’s basic requirements as follows: “You have to know the key people from each company, consistently follow your documented process, communicate with all parties any changes or discrepancies, and maintain records for each transaction.”
What to Do If… You Arrange for Transportation by Motor Carrier Under the Rule, “shippers” are those that arrange for the transportation of food by motor or rail carrier within the United States. This definition explicitly includes freight brokers.
Under Section 1.908(b), shippers have specific responsibilities related to common produce shipments, including developing and implementing written procedures that are adequate to ensure vehicles and equipment meet design specifications, are properly cleaned, and are otherwise in “appropriate sanitary condition” for the transportation of food; and, ensuring adequate temperature control is provided if needed for safety, as opposed to merely preventing spoilage.
For example, Section 1.908(b)(2) provides that a shipper of food that requires temperature control for safety (e,g. fresh-cut produce) must “specify in writing to the carrier…and, when necessary, the loader, an operating temperature for the transportation operation including, if necessary, the pre-cooling phase.”
One approach to meeting these requirements is for the “shipper,” often a truck broker, to instruct the carriers it hires, as part of its carrier onboarding process, as to (i) its trailer and equipment specifications; (ii) its cleaning instructions regarding frequency (and/or triggering events, e.g., an odor from a prior haul) and method; (iii) the need for the carrier to maintain air temperatures in the conveyance as instructed on the bill of lading or as instructed by the shipper if no temperature instruction appears on the bill of lading, or if conflicting bills of lading are issued (as when multiple pickups are involved in a single shipment); and (iv) the need to record air temperatures in transit and to present temperature records to the shipper or receiver upon request. “One-time notification” is sufficient under the Rule.
Burroughs of TIA supports this approach: “We even offer our members a sample checklist to use when working with their motor carrier and customers.”
Additionally, although arguably redundant in light of Section 1.908(a)(6) (quoted above) when working with carriers subject to the Rule (annual revenue in excess of $500,000), shippers may want to instruct carriers during the onboarding process that if any food product is subjected to temperature abuse, or comes loose from shipping containers, or if any seals must be broken prior to delivery to the contract destination, the shipper is to be contacted for instructions before the product is sold or otherwise distributed.
Under Section 1.908(b) of the Rule, shippers are also expected to communicate safety specifications to “loaders.” Loaders are defined by the Rule as, “a person that loads food onto a motor or rail vehicle during transportation operations,” which would include produce suppliers and coolers alike.
One approach to communicating with loaders is for the shipper to provide a food safety ‘checklist’ or ‘load sheet’ which the loader agrees to incorporate into its loading procedures for each of the shipper’s loads.
As an example, this checklist might provide that loaders are to confirm that: (i) the trailer is clean and free from any off-odors; (ii) the trailer’s walls, insulation, and air delivery chute are intact and in good condition; (iii) a portable temperature recorder is placed in the trailer; and (iv) temperature instructions are given to the carrier.
Additionally, the shipper’s checklist may provide that the loader’s equipment (e.g., forklifts) and loading area are clean and workers wash their hands and meet adequate standards for hygiene.
“It’s important to ensure that brokers work with their customers to ensure that all necessary sanitary requirements are relayed properly to motor carriers and, when necessary, the loader,” Burroughs explains. “One way to meet this requirement is to include all information in writing through a rate confirmation.”
What to Do If…You Load Produce onto Carriers Section 1.908(c) of the Rule provides requirements specific to “loaders.” These requirements are in addition to any instructions the shipper may give to the loader under Section 1.908(b) (discussed above).
First, before loading product that is not in a completely enclosed container, the loader must determine, in light of the specifications provided by the shipper, that the conveyance is in “appropriate sanitary condition for the transport of food.” For example, “it is in adequate physical condition, and free of visible evidence of pest infestation and previous cargo that could cause the food to become unsafe during transportation.”
Second, before loading product that requires temperature control for safety (e.g., fresh-cut produce), the Rule requires loaders to verify (again, in light of the shipper’s specifications) that the conveyance is adequately prepared (e.g., pre-cooled) for the transportation of the produce in question.
Although in some cases it may be unclear if a certain food item is in a “completely enclosed container” or whether temperature control is needed for safety, given that the requirements of the Rule are generally consistent with best practices used by produce professionals for marketability (e.g., prevention of spoilage) and food safety, one approach—as stated above—would be to apply Rule-compliant practices to all food shipments and know you are covered in any event.
What to Do If…You’re a Receiver of Fresh Produce The receiver-specific portion of the Rule, Section 1.908(d), is stated in a single paragraph—
Upon receipt of food that requires temperature control for safety under the conditions of shipment, the receiver must take steps to adequately assess that the food was not subjected to significant temperature abuse, such as determining the food’s temperature, the ambient temperature of the vehicle and its temperature setting, and conducting a sensory inspection, e.g., for off-odors.
This provision is a good example of a practice that produce professionals are already implementing (for both marketability and food safety reasons), but is now required by law. This receiver-specific provision should be read in conjunction with Section 1.908(a)(6) requiring appropriate steps be taken by any party that becomes aware of a possible material failure of temperature control or other conditions that may make the food in question unsafe.
The phrase “significant temperature abuse” suggests the FDA recognizes that some temperature variances do not threaten food safety, and is consistent with other sections of the Rule where qualified produce professionals are expected to make food safety determinations based on the relevant circumstances.
What to Do If…You’re a Carrier of Fresh Produce The carrier-specific sections of this Rule are Sections 1.908(e) and 1.910(a-b). Section 1.908(e) concerns operational requirements, while Section 1.910 concerns a carrier’s training requirements, which can be satisfied by having its personnel take an hour-long online course developed by the FDA (found at https://collaboration.fda.gov/sanitary_transportation_carrier_training/)
According to the FDA, only carriers have a training requirement because shippers, loaders, and receivers have training requirements under other FSMA rules (e.g., Produce Safety and Preventative Controls) sufficient for the purposes of the Sanitary Transportation rule.
Operationally, Section 1.908(e) requires produce carriers perform in accordance with their agreements with shippers, insofar as sanitary transportation is concerned. Consequently, a carrier’s breach of contract may also be a violation of the Sanitary Transportation rule, giving the FDA grounds for taking action against the carrier.
The text of this section (which dovetails with Section 1.908(b) and other sections of the Rule) states, in part—
When the carrier and shipper have a written agreement that the carrier is responsible, in whole or in part, for sanitary conditions during transportation operation, the carrier is responsible for the following functions as applicable per the agreement: (1) A carrier must ensure that vehicles and transportation equipment meet the shipper’s specifications and are otherwise appropriate to prevent the food from becoming unsafe during the transportation operation. (2) A carrier must, once the transportation operation is complete and if requested by the receiver, provide the operating temperature specified by the shipper….and, if requested by the shipper or receiver, demonstrate that it has maintained temperature conditions during the transportation operation….
The Rule, therefore, requires carriers to read, understand, and execute, according to the shipper’s instructions. If the carrier is not prepared to do so, other arrangements must be made. “Read every document and understand what is expected of you,” suggests attorney Dan Sullivan of Oak Brook, IL-based Sullivan Hincks & Conway. “The cost of compliance will always be less than the cost of litigation.”
In addition to following the shipper’s instructions, carriers that take responsibility for the sanitary condition of the conveyance (motor carriers, generally; note that rail cars, for example, may be left in the possession and control of shippers or loaders prior to shipping, in which case the carrier would not take on this responsibility), are required, under paragraph (6) of this section, to develop and implement written procedures that:
(i) Specify practices for cleaning, sanitizing if necessary, and inspecting vehicles and transportation equipment that the carrier provides for use in the transportation of food to maintain the vehicles and the transportation equipment in appropriate sanitary condition…(ii) Describe how it will comply with the provisions for temperature control….
For carriers that already have adequate standard operating procedures in place for cleaning their trailers and maintaining temperature control, simply documenting these procedures and ensuring they are followed should be sufficient to satisfy the Rule.
It’s also important to remember that carriers, like all entities subject to the Rule, are required under Section 1.908(a)(6) (fully quoted earlier in this article), to ensure food is not sold or distributed after becoming aware of a “possible material failure of temperature control or other conditions” that may make food unsafe, until a qualified individual determines the failure did not make the food unsafe.
Conclusion The entire text of the Sanitary Transportation of Food Rule (21 C.F.R. Sec. 1.900-1.912), along with Frequently Asked Questions and training materials are available on the FDA’s website.
“It only takes an hour to read these regulations,” implores Sullivan. “You owe a duty to yourself and your company to read and become familiar with them.” Further, he states, “I’ve been involved in FDA investigations, and they don’t mess around.”
“Isn’t this a wonderful way to make a living?” asks DeMatteis.
