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Interpretation Response #20-0063

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

Interpretation Response Details

Response Publish Date:

Company Name: DNA Genotek

Individual Name: Austin Udocor

Location City: Ottawa Country: CA

View the Interpretation Document

Response text:

September 25, 2020

Austin Udocor
Senior Manager
DNA Genotek
3000-5000 Palladium Drive
Ottawa, ON Canada K2V 1C2

Reference No. 20-0063

Dear Mr. Udocor:

This letter is in response to your August 13, 2020, email requesting clarification of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to the exception for infectious substances in § 173.134(b)(11). You reference "Scenario 4" on pg. 7 of the Pipeline and Hazardous Materials Safety Administration (PHMSA) guidance document titled, "Transporting Infectious Substances Safely," and ask specifically whether saliva samples used for routine direct-to-customer genetic testing or research (e.g., ancestry or pharmacogenomics testing) would apply to the scenario. In addition, you ask whether this guidance is the most current with respect to shipping specimens.

Section 173.134(b) provides a listing of material that is not subject to the HMR as a Division 6.2 infectious substance. The exception provided in § 173.134(b)(11) specifically addresses human or animal samples (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 routine testing include those for drug/alcohol, cholesterol, blood glucose level, prostate specific antibody, testing to monitor kidney or liver function, pregnancy, or tests for diagnosis of non-infectious diseases, such as cancer biopsies, and for which there is a low probability the sample is infectious (emphasis added). Based on the information you provided, it is our understanding that the saliva samples are transported for routine testing not related to the diagnosis of an infectious disease. However, in accordance with § 173.22 of the HMR, it is the shipper's responsibility to properly classify a material, and therefore, determine if the saliva samples are eligible or not for exception from regulations under the HMR.

Furthermore, with respect to the guidance document, PHMSA revised and reissued "Transporting Infectious Substances Safely" in April 2020. It is our most current general guidance on transporting infectious substances under the HMR that is available on our website. Please note that PHMSA has other useful information on the transportation of infectious substances at the following web link:

https://www.phmsa.dot.gov/transporting-infectious-substances/transporting-infectious-substances-overview

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

173.134(b), 173.134(b)(11), 173.22

Regulation Sections

Section Subject
173.134 Class 6, Division 6.2-Definitions and exceptions
173.22 Shipper's responsibility