The headlines are frightening – Ebola virus, one of the most deadly viruses known, has broken out in several African countries. Medical authorities are concerned that it could spread beyond that region, carried by travellers all over the world. Laboratories in North America and Europe are on alert for patients showing suspicious symptoms. This, in turn, means that samples and specimens must be transported for testing and verification. How can the medical community deal with transportation of such high-risk materials?
Ebola virus is considered a “hemorrhagic fever,” which affects the blood system. Its virulence is astonishing, with a fatality rate of between 50 and 90 percent. Combine this with the ability to be transmitted through casual contact, and the lack of specific vaccines or treatment, and it’s understandable why Ebola is such a feared disease. Therefore, it is all the more essential that transporters make sure that they comply with all legal and safety requirements.
Ebola virus is one of the few pathogens that is always classed as a Category A infectious substance, even in its uncultured form. The shipping description will be:
- Identification number – UN2814
- Shipping name – Infectious substance, affecting humans
- Class – 6.2 (Infectious substances)
- Packing group – Class 6.2 is not assigned packing groups
Procedures for shipping samples suspected of containing the virus will depend upon the regulations involved – the Hazardous Materials Regulations (HMR) for ground transport in the United States, the Transportation of Dangerous Goods Regulations (TDG) for ground shipment in Canada, or the ICAO Technical Instructions for Safe Transport of Dangerous Goods by Air (TI) and the IATA Dangerous Goods Regulations (DGR) for air transport. Shippers must consult the appropriate regulation for specific details. However, the general requirements are as follows:
1. Classification – Biological material suspected of containing the virus must be transported as Category A. The virus does not have to be confirmed, but there should be reason to believe the virus may be present, such as recent exposure, presence in an area where Ebola is a concern, or a set of symptoms that indicates the disease. Note that TDG specifies that infectious substances must be classified by a doctor, nurse, scientist or other professional who has the requisite knowledge to make this determination.
2. Special Emergency Requirements – Under Canada’s TDG, Ebola virus requires an Emergency Response Assistance Plan (ERAP) for any quantity. The ERAP involves establishing a team that can be sent to the site of a spill to assist local responders (usually this is a contract responder, although some organizations may put together their own team). ERAPs must be preapproved by Transport Canada, to ensure they are adequate. This means that hospitals and laboratories which foresee potential Ebola incidents should be looking now to find ERAP providers and registering their plans.
3. Packaging – Like all Category A materials, substances believed to contain Ebola virus must be packaged in a United Nations (UN) specification packaging for Category A infectious materials. These will be identified by a marking showing the letters “UN” in a circle, followed by a code that includes the words “Class 6.2”. Such packagings have gone through rigorous testing, and are well-protected against even severe accidents.
4. Hazard communication – The package must be marked with the Class 6.2 Category A label, as well as the shipping name and identification number. A dangerous goods/hazardous materials shipping paper must also accompany the shipment, giving the shipping description, as well as a 24-hour emergency telephone number. This number must connect to someone with detailed information about how emergency responders should deal with a spill. In Canada, the telephone number to contact the ERAP team must be given on the paper, as well as the Transport Canada approval number.
Note that regulations vary regarding identifying the shipment with the technical name “(Ebola virus)”. In general, this is not required to be marked on the package. However, under the ICAO/IATA regulations for air transport, the technical name must follow the shipping name on the document called the Shipper’s Declaration for Dangerous Goods.
Canada and the United States diverge when it comes to placards, the large signs displayed on vehicles carrying dangerous goods. Under U.S. regulations, placards are not required for any material in Class 6.2. However, in Canada, all shipments of Ebola are subject to an ERAP, and therefore must be placarded with the Class 6.2 placard, with the identification number, “2814,” displayed in a rectangle under the biohazard symbol.
5. Other requirements – Other regulations, such as 42 CFR (Code of Federal Regulations) in the United States, may add additional requirements that affect transportation. It is the shipper’s responsibility that all licenses and permits are obtained, and that all other regulations, such as health and safety, are addressed before the shipment.
Preparation is the key when dealing with Ebola virus, or other potentially deadly organisms. Make sure that all personnel involved in the transportation system are aware of their responsibilities, from the person who draws blood or obtains the sample, to the people who package and identify the substance for shipment.
Do you have any questions regarding how to transport Category A infectious substances, or do you need supplies for such shipments? Contact ICC Compliance Center here at 888-442-9628 (U.S.) or 888-977-4834 (Canada), and ask for one of our regulatory specialists. We can help you complete the process safely and efficiently.