Interpretation Response #10-0169 ([Wiley Rein LLP] [Mr. George Kerchner])
Below is the interpretation response detail and a list of regulations sections applicable to this response.
Interpretation Response Details
Response Publish Date:
Company Name: Wiley Rein LLP
Individual Name: Mr. George Kerchner
Location State: DC Country: US
View the Interpretation Document
Response text:
March 3, 2011
Mr. George Kerchner
Wiley Rein LLP
1776 K Street, NW
Washington, DC 20006
Ref. No. 10-0169
Dear Mr. Kerchner:
This responds to your letter regarding the applicability of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) to your client"s medical devices that contain small amounts of hazardous materials. Specifically, you ask whether such devices (copper pipe) used as part of a process to analyze human blood are subject to the HMR when they may include trace amounts of copper azide in a mixture of salts (copper phosphate, copper oxide, and copper hydroxide). The mixture is formed in the copper pipe after flushing it with an aqueous buffer solution containing sodium azide, sodium phosphate, sodium biphosphate, and sodium chloride. Your client intends to ship approximately ten pieces of the copper pipe submerged in the buffer solution and further packaged within small, individual bottles. It is your understanding that copper azide in its pure form is a Class 1 (explosive) normally forbidden for transportation in commerce. You also believe that any residual copper azide that may be on the copper pipe will not be pure copper azide, nor will it exhibit any explosive properties.
Under § 173.22, it is a shipper"s responsibility to properly classify and describe a hazardous material. This Office does not normally perform that function. However, it is the opinion of this Office that the trace amounts of copper azide that may be present in your client"s copper pipe described above is not regulated as a Class 1 explosive. We also agree with your assessment that it is not in a form or quantity that poses an unreasonable risk to health and safety or property in transportation and, therefore, is not subject to the HMR.
I trust this satisfies your inquiry. Please contact us if we can be of further assistance.
Sincerely,
T. Glenn Foster
Chief, Regulatory Review and Reinvention Branch
Standards and Rulemaking Division
173.22
Regulation Sections
| Section | Subject |
|---|---|
| 173.22 | Shipper's responsibility |