Interpretation Response #21-0002
Below is the interpretation response detail and a list of regulations sections applicable to this response.
Interpretation Response Details
Response Publish Date:
Company Name: Centers for Disease Control and Prevention (CDC)
Individual Name: Dr. Jeanne Santoli, M.D.
Location State: GA Country: US
View the Interpretation Document
Response text:
January 8, 2021
Dr. Jeanne Santoli, M.D.
Centers for Disease Control and Prevention (CDC)
NCIRD/ISD/VSAB
1600 Clifton Road, NE
Atlanta, GA 30333
Reference No. 21-0002
Dear Dr. Santoli:
This letter is in response to your January 4, 2021 email and January 8, 2021, telephone call with several members of the Office of Hazardous Materials Safety, Pipeline and Hazardous Materials Safety Administration (PHMSA) requesting clarification of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to the classification of "wasted" or otherwise expired COVID-19 vaccines. Specifically, you ask whether the unopened vaccine vials would be regulated as a hazardous material under the HMR for purposes of mailing them back to the centralized distribution depots.
Under 49 CFR 173.134(b)(1) a material that does not contain an infectious substance or that is unlikely to cause disease in humans or animals is not subject to the requirements of the HMR as a Division 6.2 material. In the absence of another hazardous material, unopened but expired or otherwise "wasted" vials of COVID-19 vaccines do not meet the definition of a hazardous material and are not subject to the HMR.
I hope this information is helpful. Please contact us if we can be of further assistance.
Sincerely,
Shane C. Kelley
Director, Standards and Rulemaking Division
Regulation Sections
| Section | Subject |
|---|---|
| 173.134 | Class 6, Division 6.2-Definitions and exceptions |