It is with great saddness  that I inform you that our industry colleague, Ed Kelly, head of the U.S. Transportation Security Administration's cargo division, died on Friday, December 4th at Inova Alexandria Hospital in Virginia as a result of complications from Legionnaire's Pnuemonia.

A longtime freight industry executive, Kelly had led TSA’s cargo security branch as general manager since September 2006. He oversaw a staff of more than 50 at the agency’s Washington headquarters as the TSA worked to implement tough new security regulations that are still being phased in across the air cargo industry.

Industry officials said his strong experience and direction of the organization helped quiet mounting frustration among carriers and shippers about TSA actions many viewed as impractical and poorly informed about cargo operations.

Ed was responsible for implementing the TSA 100% Cargo Screening Program which is set to take full effect in August 2010, and worked tirelessly with many industries, including the pharmaceutical industry, to achieve this Congressional mandate. He was instrumental in working with industry to establish the Certified Cargo Screening Facility Program within the pharmaceutical trade and was a frequent speaker at industry conferences, most recently at the IQPC Cold Chain Conference in Philadelphia last September.

My condolences to his wife, Ann, his three sons, and to his extended family.

An obituary from his hometown of Scranton, PA is available here.

Dr. David Bernstein, the highly respected regulatory and technical consultant passed away on August 18th, 2009. David's long career in the clinical trials arena extended to several biotechnology and pharmaceutical companies, providing guidance in conceptual and implementation strategy and tactics for expediting the drug development process through integrating pre-clinical formulation efforts, preparation of investigational drug supplies and scale up to commercialization activities with the clinical development plan. He acted as the principal liaison between numerous virtual organizations and their CMC contractors.

David also lectured, developed training programs and educational seminars, and founded, organized and hosted the twice-annual Pacific Region Clinical Supplies Conference (PARCS), disseminatiing, sharing and discussing technology, logistics, regulatory issues and best practices involved in implementing the Investigational Clinical Supply Process.

It goes without saying that David Bernstein has always been proud of the PARCS Conferences - always providing a first-rate, professional and valuable asset to the industry. As a colleague he was among the most knowledgable, passionate, generous, and devoted individuals in his field. As a friend he will be missed and cherished for his warmth, wit and his wisdom.

Donations in David's name can be made to:

C.E.D. Orphanage
Tony Navaro
C.E.D. Society
P.O. Box 41360
Santa Barbara, CA 93140-1360
(805) 845-8757

With only ten days to go before the new version of IATA's Perishable Cargo Regulations take affect, (July 1, 2009), I thought it would be helpful to provide links for those with questions on how and where to obtain the new regs, along with specific on the handling label  requirements (voluntary for one year, required after July 1, 2010), and provide artwork for the new handlingl label.

IATA Perishable Cargo Regulations

At the bottom of the Perishable Cargo Page are two downloads:

The new Time And Temperature Sensitive Handling Label (in multiple formats)

The new training requirements and label format

 

Delta Cargo,who last November declared that it would no longer accept shipments containing devices powered by lithium batteries in devices operating in the cargo hold (including those in temperature-sensitive shipments), has modified its position.

In a letter dated January 27, 2009 (attached below), Delta Cargo  agreed to take only approved devices. To date, Sensitech data-logging devices are the only ones approved. Sensitech has provided Delta Cargo with sufficient documentation to demonstrate that their devices meet the exception requirements provided in Special Provision 188 of 49 CFR Part 172.102(c)(1). 

Delta goes on to say that unapproved devices will not be accepted. It will be incumbant upon each individual data-logger manufacturer to prove that the lithium batteries in their devices are in compliance with the applicable Dangerous Goods regulations for content, configuration, application, and testing and/or meet the Special Provision exception requirements.  

I have kept my ear close to the ground on this issue and no other airline has taken Delta's hard-line stance. But, as I mentioned in Pharmaceutical Medical & Packaging News ColdChain Suppliment Winter/09 published earlier this month, all data logger manufacturers using lithium batteries will need to prove that their battery type meets the UN Manual of Tests and Criteria requirements (171.7) for voltage discharge rates, robustness in packaging, and lithium metal content, by October 1, 2009. Being able to prove that the batteries in their devices meet the Special Provision exception requirements can be done anytime. Companies would be well-advised to have this documented in advance, and at the ready.

You can read more on this topic in the December Archives section to the left.