Daniels Training Services, Inc. — Hazardous Materials Safety Interpretation

Page 11200 New Jersey Avenue, SE Washington, DC 20590 U.S. Department of Transportation Pipeline and Hazardous Materials Safety Administration March 9, 2021 Mr. Daniel Stoehr Daniels Training Services, Inc. P.O. Box 2032 Freeport, IL 61032 Reference No. 20-0062 Dear Mr. Stoehr: This is in response to your August 5, 2020, email requesting clarification of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to transporting COVID-19 diagnostic samples. Specifically, you ask whether the “Safety Advisory Notice for the Transportation of COVID-19 Diagnostic Samples” issued on June 19, 2020, by the Pipeline and Hazardous Materials Safety Administration (PHMSA)1 prohibits a person from offering for transportation in commerce a COVID-19 diagnostic sample (e.g., nasal swabs, vials of sputum, and other related items) as a Category B infectious substance (Division 6.2) in conformance with the provisions specified in § 173.134(b)(10) of the HMR. The answer is no. As provided by § 173.134(b)(10), a Division 6.2 material—other than a Category A infectious substance—is not subject to the requirements of the HMR as a Division 6.2 material when contained in a patient sample being transported for research, diagnosis, investigational activities, or disease treatment or prevention, or a biological product, when such materials are transported by a private or contract carrier in a motor vehicle used exclusively to transport such materials. 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 1 See https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/2020- 06/UN3373%20COVID%2019%20Safety%20Advisory.pdf#

Page 2Edmonson 20-0062 From: INFOCNTR (PHMSA) To: Subject: Date: Hazmat Interps; Dodd, Alice (PHMSA) FW: Request Letter of Interpretation for Classification of COVID-19 Samples Thursday, August 13, 2020 10:18:27 AM Dear Alice, Please see below for letter of interpretation. Would you be able to assign this to Eileen? She offered to write the LOI, as she had discussed the question with Breanna previously. Please contact our office with any questions. Thank you, Sarah (HMIC) From: Edmonson, Eileen (PHMSA) Sent: Tuesday, August 11, 2020 2:49 PM To: Jones, Breanna CTR (PHMSA) <breanna.jones.ctr@dot.gov> Cc: Foster, Glenn (PHMSA) <Glenn.Foster@dot.gov> Subject: RE: Request Letter of Interpretation for Classification of COVID-19 Samples HI Breanna, Yes, he can use § 173.134(b)(10) to transport COVID-19 patient samples. We’ve been doing a lot of work on the subject of transporting COVID-19 samples (e.g., safety advisory and online classes) but these products emphasize the use of rigid outer packagings. They only briefly reference the existence of other exceptions, if they mention them at all. So, no, there is no existing letter to send him. And, though it’s probably not preferred, we need to create a letter that says this. So can you please forward this letter to Alice and ask that she assign it to me? I would greatly appreciate it. Also, let me kknow if you need anything else. Sincerely, Eileen From: Jones, Breanna CTR (PHMSA) <breanna.jones.ctr@dot.gov> Sent: Thursday, August 06, 2020 4:27 PM To: Edmonson, Eileen (PHMSA) <eileen.edmonson@dot.gov> Subject: FW: Request Letter of Interpretation for Classification of COVID-19 Samples#

Page 3Hi Eileen, This is the e-mail from Daniel. If we can get him guidance without having to submit this a letter that would be preferred. When I spoke to him earlier, he gave me the brief version of what he’s looking for. For the COVID-19 notice, he wants to know if it’s possible to take advantage of the exceptions in 173.134(b)(10). The notice doesn’t explicitly say whether or not the exceptions are available to use. https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/2020- 06/UN3373%20COVID%2019%20Safety%20Advisory.pdf His entire e-mail is below if you prefer to get his question in its entirety. Again, please let me know if you have any thoughts on this or guidance to offer. It is greatly appreciated! Regards, -Breanna From: Daniel Stoehr [mailto:info@danielstraining.com] Sent: Wednesday, August 5, 2020 12:56 PM To: INFOCNTR (PHMSA) <INFOCNTR.INFOCNTR@dot.gov> Subject: Request Letter of Interpretation for Classification of COVID-19 Samples CAUTION: This email originated from outside of the Department of Transportation (DOT). Do not click on links or open attachments unless you recognize the sender and know the content is safe. I request a letter of interpretation for the following. A person will offer for transportation by highway the specimens collected from persons during routine testing for the SARS-CoV-2 virus. Per CDC guidance referenced by USDOT/PHMSA, the patient specimens will be classified as a Category B infectious substance (Division 6.2) hazardous material. The patient samples will be offered for transportation and transported in a manner eligible for the exception from full regulation at 49 CFR 173.134(b)(10). The USDOT/PHMSA Safety Advisory Notice for the Transportation of COVID-19 Diagnostic Samples issued June 19, 2020 seems to indicate that patient specimens should be classed and described as "UN3373, Biological substance, Category B, 6.2". It also provides guidance on the correct packaging and hazard communication for transportation of the patient specimens subject to full regulation pursuant to 49 CFR 173.199. However, the Safety Advisory Notice also contains the following sentence, "To ensure their safe transportation, SARS-CoV-2 diagnostic samples must be packaged and offered for#

Page 4transportation in conformity with the applicable requirement in the HMR for Category B infectious substances." The use of the word "applicable" leaves open the possibility that an applicable requirement of the HMR - such as the exception at 49 CFR 173.134(b)(10) is acceptable. Also, the Safety Advisory Notice refers to exceptions to the HMR for Category B infectious substances; specifically, those of 49 CFR 173.134(b) and (c) and does not forbid their use. My question: does the above-referenced Safety Advisory Notice (while in effect) preclude a person from offering for transportation in commerce a COVID-19 diagnostic sample (e.g., nasal swabs, vials of sputum, and other related items) as a Category B infectious substance (Division 6.2) subject to the exception from regulation at 49 CFR 173.134(b)(10)? Daniel Stoehr Daniels Training Services, Inc. 815.821.1550 Info@DanielsTraining.com www.DanielsTraining.com Subscribe to my Monthly Newsletter How'd I do? Click here to write a review.#