Interpretation Response #19-0036

Below is the interpretation response detail and a list of regulations sections applicable to this response.

Interpretation Response Details

Response Publish Date: 03/10/2020

Company Name: Hazmat Safety Consulting

Individual Name: Bob Richard

Location State: IL Country: US

View the Interpretation Document

Response text:

March 10, 2020

Bob Richard
President
Hazmat Safety Consulting
5724 North Pulaski Road 
Chicago, IL 60646

Reference No. 19-0036

Dear Mr. Richard:

This letter is in response to your March 15, 2019, email requesting clarification of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to a glucose monitoring health care product. Specifically, you describe the device and its handling, as follows, and ask whether it should be transported as a Division 6.2, medical waste or used healthcare product:

• The device has a very small sharp that is imbedded in a hard-plastic casing and is not accessible;
• The sharp only penetrates the outer level of skin when the spring-loaded applicator is pressed against the skin, and a patch is applied;
• Following use, the device and patch are sent for recycling to a designated collection site;
• A return kit is provided to the user and they are instructed to rinse the device prior to placing it in the packaging and shipping for recycling.

In accordance with § 173.22, it is the shipper's responsibility to properly classify a hazardous material and this Office does not normally perform this function. That said, in the absence of explicit instruction from the manufacturer to fully inform the customer on pathogen concerns and how to disinfect the device, there are three potential shipping scenarios for the user returning the kit:

1. If the person returning the kit determines that the device is not known or reasonably expected to contain a pathogen, either because the user has not exposed the device to a pathogen or has disinfected it, then it does not meet the definition of a Division 6.2 infectious substance and does not need to be shipped as a hazardous material. Note, the instruction to rinse the device may not be sufficient to remove a pathogen.

If the person returning the kit has knowledge or a reasonable expectation that the device contains a pathogen, the device may not be offered for transportation without being appropriately classified, described, and packaged as a Division 6.2 infectious substance.

2. If the person returning the kit determines that the device is known or reasonably expected to contain a pathogen that meets the definition of a Category B infectious substance, it must be shipped as "UN3291, Regulated medical waste, n.o.s., 6.2, II."

3. If the person returning the kit determines that the device is known or reasonably expected to contain a pathogen that meets the definition of a Category A infectious substance, it must be shipped as "UN2814, Infectious substances, affecting humans, 6.2."

The accompanying brochure, "Transporting Infectious Substances Safely," may assist your client in providing instruction to the customer in making the determination if the return kit must be shipped as containing a hazardous material. Customers may also wish to seek assistance on classification and packaging requirements from the common carrier that they are using to ship the return kit.

I hope this information is helpful. Please contact us if we can be of further assistance.

Sincerely,

Dirk Der Kinderen
Chief, Standards Development Branch
Standards and Rulemaking Division

173.22

Regulation Sections