When it comes to shipping biological laboratory and patient specimens, it may seem like there are more questions than solutions. Laboratory personnel who ship specimens, regardless of the type, must be trained to do this. But how do they know which regulations cover their shipments? Confusion increases when acronyms that are familiar in the industry are introduced—IATA, ICAO, DOT, DGR, UNSCOE, PHMSA, FAA. Knowing what the abbreviations stand for, in and of itself, isn’t helpful without also knowing the relationships that exist among the various organizations. If a specimen is packaged, marked, labeled, or documented improperly, the shipment may be subject to rejection, fines, and other consequences. This article will not only explain the different acronyms; it will outline the relationships among the entities the letters stand for. If I succeed, by the time you have finished reading, you will know which organizations’ regulations you need to comply with, and ultimately, how best to avoid package rejection and potential fines.
All transport regulations consider any substance that may cause harm to people, property, or the environment as a hazardous material. Infectious substances are known to cause harm (in the form of disease) to humans and animals; therefore, when infectious substances are transported, they are subjected to the hazardous materials transport regulations. The term “infectious substance” includes biological specimens, laboratory specimens, and any biological specimen taken from a human or animal; therefore, all of these substances are also subject to the transport regulations.
The United Nations (UN) is the primary source for most transport regulations. The UN gathers a group of experts from around the world to form the UN Subcommittee for the Transport of Dangerous Goods (UNSCOE). This subcommittee meets on a regular basis to discuss the proper methods for safely transporting dangerous goods or hazardous materials. The World Health Organization (WHO) and other industry experts are also consulted, to ensure all potential risks are addressed. Every two years, the UNSCOE publishes its “Recommendations on the Transport of Dangerous Goods—Model Regulations.” The Model Regulations are the basic standard for all international shipments by all modes of transport: road, rail, sea, and air.
Due to increased risk, hazardous materials shipped by air require more stringent regulations. The International Civil Aviation Organization (ICAO), which is another agency of the UN, adds additional restrictions to the UN Model Regulations for shipments by air and publishes these regulations as the “Technical Instructions for the Safe Transport of Dangerous Goods by Air” (TI). The ICAO TI is the standard for all international flights carrying hazardous materials. It is also recognized and enforced by some national civil aviation organizations.
The International Air Transport Association (IATA) is another important international organization. IATA is a global trade organization of airlines and air carriers whose primary purpose is to ensure both safety and efficiency for all aspects of air transportation, including shipping hazardous materials. Airline membership in IATA is not mandatory; however, the majority of air carriers, such as FedEx, UPS, Delta Airlines, and United Airlines, are members of IATA. Since the ICAO TI contains all of the regulations necessary to ensure the safe transport of hazardous material by air, IATA re-publishes the ICAO TI in its “Dangerous Goods Regulations” (DGR). IATA also works closely with the air carriers and national governments to determine more efficient methods of shipping hazardous materials. If there are efficiency-related changes that do not compromise safety, IATA includes these changes in the DGR.
Occasionally, air carriers or countries will require regulatory changes or additions that are not included in the general IATA regulations. In these cases, IATA publishes the additional restrictions as organization-specific variations to the regulations, and refers to them as State and/or Operator Variations. For any shipment, it is highly recommended to review, and comply with, all of these additional restrictions. Since the IATA DGR contains all of the regulations for safety, all of the industry recommendations for efficiency, and any additional specific carrier or country requirements, the IATA DGR is recognized as the most restrictive published international regulations for air shipments. Consequently, IATA-member air carriers will only accept shipments that are in full compliance with the IATA DGR. Any shipment that is not in full compliance with the IATA DGR will be rejected. Since IATA is an industry association, and not a governing body, it does not have the authority to inspect facilities and issue fines for non-compliance. However, failure to follow the IATA DGR regulations will often result in package rejection by the air carrier, and that package rejection could be more costly than a fine, and also time-consuming.
For shipments that originate in the United States, the governing agency that regulates the local transport of hazardous materials is the Department of Transportation (DOT). The DOT has a number of agencies which handle specific aspects of transportation. The key DOT agencies for hazardous materials are the Pipeline and Hazardous Materials Safety Administration (PHMSA) and the Federal Aviation Administration (FAA). PHMSA is the agency overseeing all aspects of the transport of hazardous material by all modes of transport. PHMSA also maintains and updates the transport regulations found in the “Code of Federal Regulations” (CFR), under the Transportation section, also referred to as “Title 49.” Parts 100-199 of Title 49 of the CFR are considered the Hazardous Materials Regulations (HMR).
The other DOT agency, the FAA, has a mission to provide the safest, most efficient aerospace system in the world. Since many dangerous goods are transported by aircraft, the FAA has also been authorized to enforce the HMR for all air shipments. Both PHMSA and the FAA employ inspectors who visit any facility involved in the transport operation, including shippers, forwarding agents, airlines, package storage facilities, air carriers, and the receiving party. These inspectors use the HMR from 49 CFR as the guideline for inspections, and any violation of the regulations will be recorded, and may result in a fine.
In order to ensure that any shipment of biological material or laboratory samples taken from patients reaches its destination, a shipper must follow the regulations published in both the 49 CFR and the IATA DGR. Fortunately, great effort has gone into ensuring there is harmony between the different regulations. For example, in section 171.22 of the 49 CFR, the DOT recognizes the ICAO TI as an equivalent standard for air transport within the U.S., and compliance with the ICAO TI is acceptable. Since all of the regulations found in the ICAO TI are also found in the IATA DGR, if the air shipment is in compliance with the IATA regulations, including any U.S. specific variations listed in the IATA DGR, it will not be rejected or subject to fines.
David Creighton, regulatory and training manager for Maryland-based Saf-T-Pak, sits on the Dangerous Goods Training Association’s Board of Certification and has been recognized as a Dangerous Goods Professional. As Saf-T-Pak’s regulatory expert, he addresses groups ranging from government agencies and pharmaceutical companies to clinical trial sites. He also serves as Saf-T-Pak’s Training Product Manager and oversees the development of Saf-T-Pak’s training products.
This column addresses compliance, regulatory, legal, certification, and additional concerns in the lab. Readers can submit questions to [email protected].