16 FOOD LOGISTICS | MARCH 2016 www.foodlogistics.com

COOL INSIGHTS BY MARC BEASLEY

FDA TO FINALIZE THE FSMA SANITARY TRANSPORT RULE

The Food and Drug Admin-istration’s (FDA) sanitary transportation rule under

the Food Safety Modernization Act (FSMA) applies broadly to food products that are temperature-con-trolled for safety (meat, poultry, seafood, unpasteurized juices and processed produce), as well as food that is at risk for spoiling if not held under specific temperature conditions.

The FDA is scheduled to publish the final rule on March 31, 2016. This article reflects Sensitech Inc.’s understanding of the rule at the time of this writing and it is not a substitute for reviewing the final rule’s full text.

The rule emphasizes prevention as the best approach to food safety problems, supporting this by setting requirements for companies en-gaged in the ground transportation of food. Specific requirements are outlined for shippers, carriers and receivers, yet the rule makes carriers the primary focus since they are per-

forming the transportation activity.Tightening control of the cold chain

can deliver business benefits such as improved efficiency, reduced perish-able cargo shrink and better quality of temperature-sensitive cargo.

The rule identifies three themes of interest to customers:

➊ DocumentationThis includes monitoring and

recording information that shows whether a process or action was in compliance. Examples include moni-toring temperature during transpor-tation, product temperature prior to loading, or pre-cool temperature of a truck. Documentation is subject to auditing and must be accessible within certain time frames and main-tained for a minimum length of time. Record-keeping and data collection are an integral part of good cold chain management.

Customers have been asking about moving from paper to elec-tronic record-keeping. Key benefits of electronic record-keeping include ease of access, security and central-ized control. Companies are encour-aged to work with a solution offering an Internet-enabled application designed and built to comply with 21 CFR Part 11 FDA guidance and to meet current Good Manufacturing Practices (GMP) guidelines for elec-tronic recording keeping. Shippers, for instance, can use this system to document pre-loading inspections and product pre-cooling.

➋ TrainingWritten procedures and agree-

ments are required under the rule, which necessitate the need to provide and verify training for ship-pers, carriers and receivers involved in transportation. Furthermore, the rule requires that “competent supervisory personnel” are respon-sible for ensuring that transporta-tion operations are carried out in compliance with all requirements.

This requirement provides a way to clearly identify the critical supply chain tasks to satisfy the food safety plan, the rule’s requirements and who is accountable for them.

➌ CommunicationThe rule specifies that the shipper

is responsible for communicating to the carrier, in writing, all con-ditions necessary to protect food from adulteration during transport, including trailer condition and sanitation, refrigeration settings, and pre-cool temperature. At the end of transportation, the carrier must demonstrate that temperature conditions have been maintained, by “any appropriate means agreeable to the carrier and the shipper.” This allows the shipper to take responsi-bility for acquiring and maintaining temperature records. The rule places emphasis on the communication between shippers and carriers.

Automation of data collection is a useful strategy. Many customers are utilizing the benefits of wireless temperature monitoring, which eliminates the need to physically interact with a device. This enables the data, such as end-of-trip reports and email alerts, to be shared with appropriate partners at the moment a temperature excursion occurs, an appointment will be missed, a door is opened, or the truck arrives at the receiver’s location.

Together, these activities can min-imize the risk of foodborne illness, secure the integrity and safety of food, comply with standards and reg-ulations, and increase supply chain visibility for all participants.

Marc Beasley is vice president of strategic marketing and business devel-opment for food at Sensitech Inc.

B E A S L E Y

• The FSMA’s sanitary transport

rule emphasizes communication

between shippers and carriers.

If it’s not fresh, you need to know.Before she does.

For perishable products, the sooner you know about a potential delivery problem or temperature excursion, the better. With Sensitech’s Inbound Real-Time System, you see the what, where, when, and why of your entire global cold chain in time to make critical decisions.

• Know where and when things go wrong, so you can take proactive steps—like re-routing a delayed shipment or filing a claim.

• Get transparent, real-time visibility of carrier performance, so you know whether you’re getting what you commissioned.

• Simplify cold chain monitoring with a comprehensive solution that includes data collection, analysis, and expert support.

Sensitech helps you protect product freshness every step of the way.

Product temperature and location visibility—in real time.

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