Regulatory snares affect Envirotainer, OHL Solutions

OHL Solutions (Brentwood, TN) may be the first air-cargo 3PL to run afoul of the US Transportation Security Administration’s inspection rules for packages being conveyed on domestic passenger aircraft. During 2010, TSA imposed a requirement for air carriers to have packages screened for explosives or other terrorism-related threats; the pharma industry scrambled to set up a system that allowed its own facilities, or those of its logistics providers, to do the inspection (the “Certified Cargo Screening Program,” or CCSP). Now, in an incident that occurred in January 2010, OHL Solutions was found to have falsified its inspection documents at an Indianapolis facility, resulting in the fine from TSA. (It is not known whether pharma packages were involved in the misreporting; however, OHL’s website indicates that the company does handle healthcare products.) Currently, all shippers are awaiting next steps by TSA, which is under the gun from Congress to expand the inspection program to all air cargo (cargo as well as passenger flights) from all locations inbound to the US.

Meanwhile, Envirotainer (Lagga Marma, Sweden) has had to amend its September announcement that it was now cleared to use its active (RKNe1) temperature-controlled containers on flights by US airlines. FAA has noted that while the containers are cleared under a “technical standard order” procedure, they are yet to be cleared under an “operational” regulation. Although Envirotainer pioneered the use of active temperature control (accomplished by having batteries that run an internal heating/cooling compressor), the company’s device has been hung up for several years first in a cross-approval snag between FAA and the European Aviation Safety Agency (EASA) that was resolved last year; and now by the FAA procedure.

In reponse to a query from Pharmaceutical Commerce, Nicholas Martin, director of R&D and QA at Envirotainer, said: “FAA issued an approval for the Envirotainer RKNe1 on Sept. 7, 2011. It was later discovered that the approval reference made by FAA did not cover the operational use of the container. The information letter sent out by FAA is clarifying this and Envirotainer has not released any RKNe1 units to US carriers. We are currently working on supplying additional requested data to FAA to expedite approval for operational use.”