Most of the questions I receive come from industry. A few from government. And a few like this one on July 28, 2016:
I am working on a small study and we will be collecting stool samples from subjects. Subjects will receive directly at their home the kit which includes a small tube pre-filled with 5mL of ethanol. They will be asked to add sample to the pre-filled tube, put it back in the kit and send it via courier to our lab facility.
Researchers sending the kit to subjects have all training for shipping hazardous materials and shipping materials meet the IATA and DOT regulation.
The question I have is regarding patient shipping the kit back to the lab. What regulation applies to this part?
My initial reply later that day:
I will research that and get you an answer soon.
And here is my answer a long time later on October 8, 2016 (I’ve been working on my response times!):
I apologize for my delay in responding. Hopefully my answer can still be of some use to you. Please see below.
- The samples may not be subject to regulation as a Division 6.2 Infectious Substance if they meet the criteria of 49 CFR 173.134(b)(11):
(11) A human or animal sample (including, but not limited to, secreta, excreta, blood and its components, tissue and tissue fluids, and body parts) being transported for routine testing not related to the diagnosis of an infectious disease, such as for drug/alcohol testing, cholesterol testing, blood glucose level testing, prostate specific antibody testing, testing to monitor kidney or liver function, or pregnancy testing, or for tests for diagnosis of non-infectious diseases, such as cancer biopsies, and for which there is a low probability the sample is infectious.
- The ethanol may be subject to the Excepted Quantity exception due to its volume. If shipped as an Excepted Quantity, only a few of the DOT Hazardous Material Regulations apply (see 49 CFR 173.4a).
- If shipped as a fully regulated hazardous material, then the shipment returned to you by the patient is subject to regulations since it is being done for a business and is therefore “in commerce”.
- However, DOT regulations (more research will be required but I think IATA regulates it the same way) allow for more than one shipper for a HazMat. Each shipper is responsible for the aspect of offering a HazMat for transportation that it performs. In other words, the patient/customer is subject to the regulations for what they do and you are subject for what you do. In that case, it is best for you to do as much as possible for the customer, e.g. shipping papers, packaging, labels, markings, directions to complete, &etc. You then, are responsible for these aspects. The customer is left only to package the HazMat and make final preparation for shipment. This should be done only according to directions you provide.
In sum, I suggest you determine if what you intend to ship is excepted from regulation. If so, its transportation should be easy. If subject to full regulation, then provide as much information and resources as possible in order to make its return to you simple.