100% Cargo Screening

What constitutes “piece level”?

By Kevin O’Donnell
Contributing Editor

The English language is fraught with tricky exceptions and ambiguity — not the least of which is that a single word can have many meanings. Take the word piece for example. A piece can be (among other things), a portion — like a piece of pie; or a distance — “down the road a piece”; it can specify a standard quantity — piece goods, which are lengths of fabric; or something more ambiguous — a piece of furniture. It can be a gun, a musical composition, a vulgar sexual connotation, and even an insult – as in describing someone as “a real piece of work.”

In the context of packaging, we generally think of a piece as a part of a whole and in the realm of the Transportation Security Administration (TSA) 100% cargo screening initiative, this has created a quagmire of confusion across the temperature-controlled healthcare product supply chain, a fair amount of head scratching among shippers, and a bit of a do-si-do among air carriers.

Before I get ahead of myself, let me provide a little background: In 2007, Congress passed the Implementing Recommendations of the 9/11 Commission Act — otherwise known as the 9/11 Act. This new law mandated that as of August 1, 2010, all cargo transported on domestic and international passenger aircraft originating in the U.S. had to be screened for explosives. This was an enormously complex and nearly impossible undertaking to implement in three years’ time. But the group within the TSA responsible for implementing this mandate under the direction of the late Ed Kelly and his successor, Doug Brittin, successfully delivered. A great deal of the success in meeting this mandate was due to a new philosophy within the organization: the willingness to reach out — rather than dictate — to industry. An outgrowth of that partnership was the implementation of the Certified Cargo Screening Program (CCSP), in which shippers or their freight forwarding agents pre-screen cargo prior to arriving at the airport, thereby avoiding potential bottlenecks or delays. Most CCSP shipper participants have been able to quickly incorporate physical screening into their shipping process with minimal expense to their operation and have qualified as Certified Cargo Screening Facilities (CCSF).

Still, some confusion exists. TSA’s overview on its website with regard to the CCSP states, “Every shipment of cargo carried on passenger aircraft will require screening at piece level, prior to being transported on any passenger aircraft. Skids and pallets will have to be taken apart, screened and reconfigured.”1 Does a unitized pallet shipment in either an active or passive insulated packaging system meet the TSA definition of “a piece”? Are the contents within these systems instead considered part of the whole?

If the shipper is part of the CCSP, the facility from which he makes such a shipment is certified as a CCSF, and the chain of custody from the shipper to the aircraft is maintained, making this a moot point. By virtue of assembling the packaging systems, sealing them closed and maintaining the chain of custody to the aircraft, shippers have met the TSA’s requirements for screening. But there are many shippers who do not fit this category and, this is presenting some consternation for them. There are other shippers who insist that the TSA regulations are not applicable to their operations because their products only move on integrator, cargo-only aircraft (like DHL, FedEx or UPS). But integrator air services are not necessarily exempt from 100% cargo screening, as freight from these providers is often contracted to move alternatively aboard legacy passenger aircraft.

An active temperature-controlled device is often considered within industry to be an integrated, autonomous unit — a piece. It is only capable of functioning with applied refrigerant — like dry ice — and requires mechanical assistance to operate within a pre-determined temperature range: a thermostat, circulating fans and batteries. More sophisticated units that can both heat and cool come equipped with compressors and external A/C capabilities as well. It is a system. When dry ice is used as a refrigerant in these (or any other) containers, it throws them into another category: Dangerous Goods. Dry ice (carbon dioxide solid) is a Class 9 hazard and if it has not been pre-screened in a Certified Cargo Screening Facility, it is subject to a separate, proprietary security screening protocol that differs from passive, non-dry ice packages.

However, for purposes of meeting the TSA requirements for screening, an active ULD container is not considered a piece but rather “conveyance equipment and part of the aircraft,” said Gary Lupinacci, assistant branch chief, Certified Screening Program, TSA/TSNM. The use of dry ice technically provides a loophole that allows airlines to screen ULD’s in such a manner as to not open them. But to meet the letter of the law, the TSA intends on closing that loophole, although the manner by which it intends to enforce this has not been finalized.

Unlike active ULD’s, passive units, which are unitized banded, strapped or sealed with tape, regardless of size (whether on a pallet or single small parcel) are considered by the TSA to be a piece, as long as they are tendered as one piece on the Air Way Bill. It is not an over pack, as some have wrongly suggested. Over packs, like multiple boxes of widgets on a pallet, clearly fall under the TSA requirement as being multiple pieces and should be “taken apart, screened and reconfigured.”A passive system — like that of an active ULD — is an autonomous unit in that it cannot perform its intended function correctly without its multiple constituents. This includes all internal components such as frozen or refrigerated phase change material (or in the case of frozen shipments, dry ice), all other ancillary packaging, i.e. corrugated or plastic sleeves, pads, dividers, insulated walls, external shrouds and, most importantly, the product contained within the package. The product is equally integral to the proper maintenance of temperature as any of the other packaging components. This grey area of meeting the TSA’s definition of piece has resulted in a double standard for screening.

Does this seem counter-intuitive? I took an informal poll among my industry colleagues, showing them two pictures. Everyone I asked agreed: the picture of the ULD was a piece and the passive system was not.

It is important to note that disassembly or opening of an insulated packaging system in transit, whether an active container or a passive package, would nullify its capabilities, invalidate its intended thermal performance, potentially compromise the quality of the drug product and could ultimately pose a risk to patient safety. If the integrity of drug packaging is in any way compromised, so is the product, according to the FDA, which is emphatically clear about tampering with the integrity of drug product.

The integrity of any temperature-controlled packaging system must be maintained and respected. To minimize risk, shippers of these product types must tender their pallet sized shipments as one piece and communicate with their freight forwarder, any third-party screening facility, and the TSA at the outbound airport(s) and convince them of the importance of maintaining the integrity of drug packaging throughout transport.

There is another — and in the long run, preferred — way to assure this: shippers of time- and temperature-sensitive drug products can virtually eliminate compromised insulated packaging risks as the result of TSA screening protocols by taking advantage of the TSA Certified Cargo Screening Program and by having their affected shipping facilities certified as well. It pays to get with the program; it will remove middle-man screening, maintain chain of custody of the product all the way to the aircraft, keep the cold chain intact, and ultimately give the shipper piece — rather, peace — of mind.

Reference
1. http://www.tsa.gov/what_we_do/layers/aircargo/certified_ screening.shtm#overview

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Kevin O’Donnell is director and chief technical advisor to industry at Tegrant Corp., ThermoSafe Brands. He can be reached at kevin.o’[email protected]. His blog, Where Cooler Heads Prevail, can be found at http://www.coolerheadsblog.com/blog/