The International Air Transport Association (IATA) is currently making revisions to its perishable Cargo Regulations Chapter 17: Air Transport Logistics for Time and Temperature-Sensitive Healthcare Products. The regulations, binding to its airline members, becomes effective July 1, 2012. Among the most significant changes affecting shippers of healthcare products are a “mandatory” use of the IATA Time & Temperature Sensitive Label and new “compatibility requirements” for the use of electronic data loggers and lithium battery-powered devices.

Use of the IATA Time & Temperature Sensitive Label — which has been voluntary up until this year — has been a contentious and confusing quagmire since it was first approved in 2010 by IATA’s responsible body, The Live Animals & Perishables Board. The healthcare industry has been slow to adopt the new label, as few are aware that its recommendation exists in the first place. The intent of the label was as a tool to identify and alert handlers within the airline industry that certain precautions — above and beyond that of general cargo — may be necessary for the handling of a particular shipment containing sensitive drug products through the display of the label on the outermost shipping container. The label is unique to healthcare products. Current regulations specify that the label is to be used in conjunction with an approved standard operating procedure (SOP), service level agreement (SLA) or other written communication among the appropriate stakeholders (shipper, forwarder, carrier, etc.). Such agreements are common practice and a clearly defined expectation among healthcare regulators globally and an integral part of current Good Distribution Practice (cGDP) for healthcare products. But beginning on July 1 of this year, IATA is adopting a new policy: use of the label shall be mandatory and required on all time- and temperature-sensitive healthcare products regardless of whether a written agreement is in place among stakeholders. This will only serve to encourage less conscientious shippers to slap a label on their packages and expect a level of service they didn’t pay for. It also can put these sensitive shipments at additional risk, as failure to comply may relegate the shipment to the dreaded and completely uncontrolled status of “general cargo.” In the airline industry’s hierarchy of freight, general cargo is the category of least priority — the antithesis of time- and temperature-sensitive. It also leaves the door open for additional costs from airlines and their service partners who may view such compliance as additional handling above current service levels and a means of generating additional revenue from shippers. 

There has been no word from IATA on how it intends to enforce this new label requirement or how to address and clarify stakeholders’ liability.

A second, more complex and more troubling issue proposed for the 12th Edition of the Perishable Cargo Regulations pertains to the use of lithium batteries in devices such as electronic data-loggers, which are often included inside shipments of temperature-sensitive healthcare products to monitor and record temperature. This extends to the use of RFID tags that emit an electromagnetic signal (and may also be powered by a lithium battery). The airlines’ concerns are to ensure that the batteries are isolated and protected in such a way as to not generate a dangerous evolution of heat and that operation of such devices does not interfere with avionics.

The language proposed for Chapter 17, Section 13, “Additional Environmental Considerations,” is expected to be finalized at the IATA Live Animals & Perishables Board Meeting next month, and made effective July 1, 2012. It states: 

Monitoring devices such as radio frequency identification (RFID) tags, and temperature loggers, which are not capable of generating a dangerous evolution of heat, may be transported when intentionally active.

When activated (i.e. “on” position), these devices must meet defined standards for electromagnetic radiation to ensure that the operation of these devices does not interfere with aircraft systems.

The shipper must verify the compatibility of the technology with airline flight data systems and the ability of the monitoring devices to be used in the healthcare products handling and transport environment.

For lithium-powered devices, the shipper must meet the requirements of IATA DGR Packing Instruction 967 and 970, or confirm that such requirements have been met by the manufacturer.

For all battery-powered devices, the shipper must confirm that the device(s) meet the applicable air-worthiness standards with regard to electromagnetic oblique radiation interference with aircraft systems, or confirm that such requirements have been met by the manufacturer.

In order for this information to be validated by the airline with their appropriate national authority and/or other parties (flight safety, security, engineering department, etc.), as necessary, the shipper should provide this information in the advance of shipment, such as in a written Service Level Agreement (SLA) 17.4.1 Section 6, Duties and Responsibilities.

Example: [Shipper Name] confirms that the monitoring device(s) used for the shipments covered under this SLA:

• are not capable of generating a dangerous evolution of heat,
• meet the defined standards for electromagnetic interference
• the operation of the device does not interfere with aircraft systems

As in the transport of Dangerous Goods, IATA has placed the onus of meeting the technical requirements of these devices squarely on the shipper. Shippers that use these devices are not likely to be experts in the nuances of lithium battery technology or electromagnetic emissions. They are also not likely qualified to make the determination as to whether or not the devices they purchase to monitor their product — from which they assume is a reputable supplier or manufacturer — meets such requirements, or that such requirements even exist! For this, IATA has provided a caveat: as stated above in the proposed text, shippers may rely on their device manufacturers to provide proof. While this a reasonable solution, the industry is largely unaware of this new requirement. This has the potential to create a real problem. On June 30th, shippers that include such devices inside their packages will be in compliance; the following day, they will not. No advance notification by IATA, no phase-in period. In fact, many of the data-logger device manufacturers I have spoken with in the past few months were not aware of the pending IATA changes. They have only three months to comply and complete the required testing across their entire range of products and be able to provide documented evidence to their customers for their air carriers if requested. Shippers must simultaneously have their service level agreements written, approved and in place. (This would be an excellent opportunity for shippers to also include specific requirements for the use of the Time & Temperature Label, if they have not done so already.)

A growing number of countries require the use of temperature data-loggers to accompany any inbound temperature-sensitive drug product shipments as evidence of chain of custody related to temperature of the product, and to maintain drug quality and assure patient safety. 

The irony of all this, of course, is that many varieties of lithium batteries are already ubiquitously present on all passenger aircraft — every flight, every day. They are in the hardware we carry on board: cell phones, laptops, mp3 players, cameras, watches, hand-held games and players, e-readers, tablets, audio recorders and laser pointers, just to name a few. Many of these devices also emit electromagnetic signals constantly — wi-fi, Bluetooth, cellular. But these devices maintained by passengers within the cabin or contained in checked luggage in the cargo hold of aircraft are mysteriously exempt from these new regulations. What IATA says it is concerned about is what happens below the wing — in cargo — where awareness of a hazardous situation may go undetected and access to the cargo while in the air may be impossible. Any fire on board an aircraft is unacceptable, and lithium battery fires are particularly nasty. They generate a constant evolution of heat and release toxic gases.

Extinguishing them is difficult no matter where they occur. And while the dozens of lithium batteries that are in active use around us in the cabin before, during and after our flight have caused fires in the past, they are exempt from any scrutiny, the few that may safely reside in packages under our feet are subject to strict regulation. The ludicrousness of this double standard cannot be overlooked. There have been nearly a dozen aircraft or tarmac fires since 2005 resulting from faulty consumer devices and improperly packaged bulk lithium batteries. There has never been a single fire involving monitoring devices containing a single, small, button-sized lithium battery. 

Complying with the new regulations without any advance notice by IATA will undoubtedly upset the supply chain and may force some shippers away from using monitoring devices altogether. This much I can tell you: a data-logger never brought down an airplane and a data-logger within a healthcare shipment onboard an aircraft will not compromise passenger or crew member safety. The lack of one, on the other hand, will.  
 

Kevin O’Donnell is a senior partner at Exelsius Cold Chain Management – U.S. He serves as chair for the International Air Transport Association (IATA) Time & Temperature Task Force, is a member of the USP Expert Committee on Packaging, Storage and Distribution, and is a temporary advisor to the WHO. He blogs at www.clutchcargo.us and can be reached at [email protected].