Best Practices: Air Transport of Biologics
Michael Burdick has 10 years of experience as a Special Agent with the FAA. In advance of his talk at the BioLogistics Summit, he shares some common pitfalls of transporting biologics and the best way to overcome those challenges.
Cold Chain IQ: Could you briefly summarize the FAA's role in regulating the shipment of Hazardous Materials?
Michael Burdick: FAA’s Office of Hazardous Materials Safety strives to increase safety in air transportation by preventing hazardous materials accidents and incidents aboard aircraft. Over 100 special agents are dedicated to enforcement and educational outreach and ensuring compliance with U.S. Department of Transportation regulations.
Hazardous materials or dangerous goods sent using commercial transportation must comply with Hazardous Materials Regulations, 49 CFR Parts 171-179. These regulations apply to those who offer, accept, or carry hazardous materials to, from, within, and across the United States.
FAA’s special agents conduct inspections and investigations of shippers (those who offer hazardous materials for air transportation), those who accept and transport the hazardous materials (the air carriers), and those involved in compliance and enforcement.
Agencies that handle hazardous materials shipments for shippers or carriers, such as freight forwarders and repair stations, are subject to the Hazardous Materials Regulations and FAA inspection. Because these regulations apply to the aircraft cabin as well as the cargo hold, passengers and their baggage are also subject to these rules and FAA jurisdiction.
FAA Special Agents inspect U.S.-registered air carriers (certificate holders) for compliance with FAA hazardous materials training requirements found in 14 CFR Part 121 and Part 135. Air carriers in the U.S. cannot carry hazardous materials as cargo until they have an FAA-approved hazardous materials training program. The FAA principal operations inspector assigned to the carrier coordinates this approval.
Cold Chain IQ: Are the compliance and regulatory issues that relate to biologics more stringent than other hazardous materials?
Michael Burdick: Depending on the hazard class and the nature of the product there can be other, more stringent requirements for tendering commodities into transport. Some ‘biologics’ are additionally regulated by CDC or other federal and state agencies, which necessitates a higher security standard for preparing and tending your commodity into the transportation chain.
Cold Chain IQ: Why is it such a challenge for pharmaceutical companies to correctly classify biological agents?
Michael Burdick: The people and company who prepare and tenders hazardous materials into the transportation network are responsible for the correct classification of the commodity.
The definitions and standards that determine the hazard class or division associated with commodities are in 49 C.F.R. Part 173. There is a helpful table contained in 49 C.F.R. § 173.2 that provides the location of each hazard class definition in 49 C.F.R. Part 173. These standards are used to determine the classification of your commodity. In reviewing the appropriate sections one quickly sees that "guessing" the hazard associated with any suspected hazardous commodity is not only dangerous, it is a violation of the regulations per 49 C.F.R. § 171.2(e) when the guess turns out incorrect. When a company formulates a new product, it is the full responsibility of that company to certify that the product is properly classified per the regulations.
The best method for complying with the correct classification is to have the product tested to see which hazard classes are applicable to the commodity per the regulations. A person who understands the classifications in the HMR is the one who should make the determination as to the hazards
applicable to the commodity. It is important to note that one or more hazards may be applicable to a product and discovered when the product is tested. If such a case arises a primacy of the hazards is found in 49 C.F.R. § 173.2a.
Many companies utilize infectious substances or biological agents in research or are offering them into the transportation system in order to aid in various medical applications for humans or animals. These substances present a difficult challenge in their classification. A substance that meets the criteria of 49 C.F.R. § 173.134(a) (1) must be handled and transported as a ‘Category A’ infectious substance or ‘Category B’ infectious substance. 49 C.F.R. § 134 (a)(1)(i) and (a)(1)(ii) provide the information on how to classify these substances.
We sometimes see a misclassification of ‘Category A’ infectious substances as ‘Category B’ infectious substances, which is less stringent in its requirements for transport. Keep in mind the definitions and the hazards presented by these substances. Reviewing 49 C.F.R. § 173.134 in its entirety can provide you with the information you need to make a correct determination.
Cold Chain IQ: Besides classification, what are some other common pitfalls that pharmaceutical companies fall prey to when it comes to FAA compliance?
Michael Burdick: During the course of our inspections, Federal Aviation Administration (FAA) Special Agents notice that persons are unaware of hazardous materials transportation requirements set forth in the HMR are safety of persons and property and training them is essential.
Reviews of our case files and incident data show that improper training and lack of knowledge are the leading cause of incidents and enforcement actions, and account for a sizeable portion of civil penalties.
Proper and documented training is, in fact, a requirement and must be provided by the "hazmat employer" per 49 C.F.R. § 172.702, for all employees who handle, classify or prepare hazardous materials for transportation. A thorough review of 49 C.F.R. § 172.704 outlines the specific training requirements that are often overlooked by regulated parties. Overlooking these requirements can result in enforcement action, but more importantly, they can increase the potential for catastrophic incidents that jeopardize life and property.
When developing a new product for market, or returning product to a vendor, the required training helps to ensure the safe and timely processing of shipments. It is important to note that outside organizations may be hired to perform training. A quick internet search for "hazardous materials transportation training" will verify the plethora of training available. Experience from the field shows that although most third party training complies with existing regulations, the standard training programs offered may not be thorough enough for your specific job functions; and tailoring the program or offering supplemental training may be necessary. As a hazmat employer you will be held responsible for regulatory compliance, regardless of whether it is your employee(s) or a contractor that is performing the training. Because liability for compliance is imputed to you – the hazmat employer – you need to ensure that you completely review any training program to assure it meets regulatory requirements, not simply your company’s needs.
If you determine you are a company who offers hazardous materials in transportation, you may be interested to know that as a shipper, you are not the only entity that must train employees. Air carriers who accept hazardous materials are fully regulated, trained, and equipped to transport hazardous materials. Those carriers have procedures to ensure the safe handling of your cargo; in fact hazardous materials cargo always have a higher level of service due to its characteristics and requirements for special handling.
Aviation has the unique character of being the timeliest way to get your product to market but it is also the most vulnerable to incidents that can quickly turn serious. As a result, aviation is the most highly restricted mode of transport for hazardous materials. But, be aware that no matter what mode of transportation you select for your products, all must give training to their "hazmat employees" prior to transporting your commodity.
Cold Chain IQ: You've been with the FAA for over a decade now. What is the most interesting aspect of being a Special Agent?
Michael Burdick: My work is never boring and filled with challenges in keeping our air transportation system safe and yet efficient. The most ‘interesting’ part of my job is interacting with all the variety of shippers and commodities tendered into commerce. There are nine separate hazard classes and literally tens of thousands of commodities presented into the transportation stream every day. Biological shippers are a small yet important part of a massive myriad of hazardous materials shippers. The goal is to educate and ensure compliance with all the various requirements for getting hazardous materials safely transported.
Interview conducted by Shawn Siegel.
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