Interpretation Response #20-0077

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

Interpretation Response Details

Response Publish Date: 01/06/2021

Company Name: Neoteryx

Individual Name: Stuart Kushon

Location State: CA Country: US

View the Interpretation Document

Response text:

January 6, 2021

Stuart Kushon
Neoteryx
421 Amapola Avenue
Torrance, CA  90501

Reference No. 20-0077

Dear Mr. Kushon:

This letter is in response to your September 16, 2020, email requesting clarification of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to infectious substances. Specifically, you ask for assistance classifying a dried blood sample under the following circumstances:

• A dried blood sample on absorbent material when the blood sample on the material comes from a community study on influenza infection where the subjects are not known or presumed to be infected.
• A dried blood sample on absorbent material when the blood sample on the material comes from a community study on COVID-19 infection where the subjects are not known or presumed to be infected.
• A dried blood sample on absorbent material when the blood sample on the material comes from a subject that is presumed to be infected with influenza.
• A dried blood sample on absorbent material when the blood sample on the material comes from a subject that is presumed to be infected with COVID-19.

In each circumstance, § 173.134(b)(9) states that dried blood spots placed on absorbent filter paper or other material are not subject to the requirements of the HMR.

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

Sincerely,

T. Glenn Foster
Chief, Regulatory Review and Reinvention Branch
Standards and Rulemaking Division

173.134(b)(9)

Regulation Sections