The Food Safety Modernization Act (FSMA) was signed into law on January 4, 2011 to better protect the safety and security of America's food supply. Not all of the Act's provisions took effect immediately. The proposed rule for the Sanitary Transportation of Human and Animal Food (STHAF) is expected to be finalized in March, 2016. 

The goal of the proposed rule on Sanitary Transportation of Human and Animal Food is to prevent practices that create food safety risk. It addresses refrigeration, cleaning and proper protection of food during transportation, and would establish requirements for vehicles and transportation equipment, transportation operations, information exchange, training, records and waivers. 

It is expected to have a significant impact on trucking practices in the food industry. 

Highlights of the STHAF Proposed Rule

The comment period for the STHAF proposed rule has closed, and the final rule is expected on March 31, 2016. It applies to shippers, receivers, motor carriers, and railroads; but shippers, receivers, or carriers engaged in food transportation operations that have less than $500,000 in total annual sales are exempted. The rule also does not apply to the transportation of shelf stable food that is completely enclosed by a container. 

The STHAF proposed rule requires transportation operations to be conducted under conditions and controls necessary to prevent the food from becoming adulterated. In addition:

• The shipper will be required to specify in writing its sanitary requirements, such as the required temperature, to the carrier. 
• The shipper must inspect the trailer for cleanliness and confirm sanitation and temperatures as required. 
• Shippers must abide by recordkeeping requirements, including retaining written agreements for 12 months beyond when the agreements are in use, and retaining training records 12 months beyond when the person identified in the training record performs the duties. 
• The carrier must show the shipper, and upon request the receiver, that it has maintained appropriate temperature control during transport for food subject to temperature control requirements. 
• Motor carriers must specify in writing to shippers information about three previous cargoes hauled in bulk vehicles and the most recent cleaning of those vehicles. The carrier must develop and implement written procedures for cleaning, inspection and temperature control. Shippers and receivers may amend these responsibilities in a contract, or if they use dedicated vehicles to haul only one type of cargo. 
• The shipper is responsible for ensuring that competent supervisory personnel are ensuring compliance and must have training with documentation. 
• Carriers are required to provide training about the potential for food safety problems and basic sanitary transportation practices, as well as the responsibilities of the carrier under the final rule. This training must be provided upon hiring, and the carrier must establish and maintain records documenting the training. 
• The proposed rule establishes procedures by which the FDA will waive any of these requirements if it determines that the waiver will not result in the transportation of food under conditions that would be unsafe for human or animal health and that it is in the public interest. 

Questions and Concerns

Interested parties expressed a variety of concerns during the comment period that may or may not be addressed when the final rule is published. 

• The definitions in the proposed rule of shipper, carrier and receiver have come under fire for deviating from the traditional understanding of each role, and even blurring the lines between them in some cases. The hope is that these definitions and responsibilities will be further clarified in the final rule. 
• Will the regulations lead to more cargo claims and more mitigation? Will shippers feel the need to destroy a load to mitigate a loss and comply with food safety regulations? 
• Seals are purposely not addressed in the proposed rule. FDA states that this is because seals are generally for the purpose of food security, not food safety, so the rule did not address them. 
• Will there be more total losses where salvage will not be permitted? Will shippers be forced to destroy loads rather than sell or donate loads that cannot be used? 

Readiness

One of the biggest concerns in the transportation sector is that companies will not be ready when the rules are finalized. The FDA proposed that the final rule go into effect 60 days after its publication date, and businesses must comply by one year after the effective date. Small businesses will be given 2 years to comply. 

Anecdotal evidence points to in adequate preparation in the trucking sector so far. While the rule may not yet be set in stone, it is best for fleet operators and shippers to understand FSMA and to begin dialogues with partners in order to determine how all parties will meet the new requirements. 

The fact remains that the rule is pending, so now is the time to begin your compliance planning. For more information and to subscribe to email updates about FSMA, visit the FDA's FSMA page at http://www.fda.gov/fsma.