{"operation":"document","citation":"20-0062","title":"Daniels Training Services, Inc. — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2021-03-09","effective_on":null,"summary":"20-0062 response to Daniels Training Services, Inc. concerning 173.134.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-20-0062.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-20-0062.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-20-0062","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/docs/standards-rulemaking/hazmat/interpretations/74791/200062.pdf","body":"<<>>\n\n1200 New Jersey Avenue, SE\nWashington, DC 20590\nU.S. Department\nof Transportation\nPipeline and Hazardous\nMaterials Safety\nAdministration\nMarch 9, 2021\nMr. Daniel Stoehr\nDaniels Training Services, Inc.\nP.O. Box 2032\nFreeport, IL 61032\nReference No. 20-0062\nDear Mr. Stoehr:\nThis is in response to your August 5, 2020, email requesting clarification of the Hazardous\nMaterials Regulations (HMR; 49 CFR Parts 171-180) applicable to transporting COVID-19\ndiagnostic samples. Specifically, you ask whether the “Safety Advisory Notice for the\nTransportation of COVID-19 Diagnostic Samples” issued on June 19, 2020, by the Pipeline and\nHazardous Materials Safety Administration (PHMSA)1 prohibits a person from offering for\ntransportation in commerce a COVID-19 diagnostic sample (e.g., nasal swabs, vials of sputum,\nand other related items) as a Category B infectious substance (Division 6.2) in conformance\nwith the provisions specified in § 173.134(b)(10) of the HMR.\nThe answer is no. As provided by § 173.134(b)(10), a Division 6.2 material—other than a\nCategory A infectious substance—is not subject to the requirements of the HMR as a Division\n6.2 material when contained in a patient sample being transported for research, diagnosis,\ninvestigational activities, or disease treatment or prevention, or a biological product, when such\nmaterials are transported by a private or contract carrier in a motor vehicle used exclusively to\ntransport such materials.\nI hope this information is helpful. Please contact us if we can be of further assistance.\nSincerely,\nT. Glenn Foster\nChief, Regulatory Review and Reinvention Branch\nStandards and Rulemaking Division\n1 See https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/2020-\n06/UN3373%20COVID%2019%20Safety%20Advisory.pdf\n\n<<>>\n\nEdmonson\n20-0062\nFrom: INFOCNTR (PHMSA)\nTo: Subject: Date: Hazmat Interps; Dodd, Alice (PHMSA)\nFW: Request Letter of Interpretation for Classification of COVID-19 Samples\nThursday, August 13, 2020 10:18:27 AM\nDear Alice,\nPlease see below for letter of interpretation. Would you be able to assign this to Eileen? She offered\nto write the LOI, as she had discussed the question with Breanna previously.\nPlease contact our office with any questions.\nThank you,\nSarah (HMIC)\nFrom: Edmonson, Eileen (PHMSA)\nSent: Tuesday, August 11, 2020 2:49 PM\nTo: Jones, Breanna CTR (PHMSA) \nCc: Foster, Glenn (PHMSA) \nSubject: RE: Request Letter of Interpretation for Classification of COVID-19 Samples\nHI Breanna,\nYes, he can use § 173.134(b)(10) to transport COVID-19 patient samples. We’ve been doing a lot of\nwork on the subject of transporting COVID-19 samples (e.g., safety advisory and online classes) but\nthese products emphasize the use of rigid outer packagings. They only briefly reference the\nexistence of other exceptions, if they mention them at all. So, no, there is no existing letter to send\nhim. And, though it’s probably not preferred, we need to create a letter that says this.\nSo can you please forward this letter to Alice and ask that she assign it to me? I would greatly\nappreciate it.\nAlso, let me kknow if you need anything else.\nSincerely,\nEileen\nFrom: Jones, Breanna CTR (PHMSA) \nSent: Thursday, August 06, 2020 4:27 PM\nTo: Edmonson, Eileen (PHMSA) \nSubject: FW: Request Letter of Interpretation for Classification of COVID-19 Samples\n\n<<>>\n\nHi Eileen,\nThis is the e-mail from Daniel. If we can get him guidance without having to submit this a letter that\nwould be preferred.\nWhen I spoke to him earlier, he gave me the brief version of what he’s looking for. For the COVID-19\nnotice, he wants to know if it’s possible to take advantage of the exceptions in 173.134(b)(10). The\nnotice doesn’t explicitly say whether or not the exceptions are available to use.\nhttps://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/2020-\n06/UN3373%20COVID%2019%20Safety%20Advisory.pdf\nHis entire e-mail is below if you prefer to get his question in its entirety.\nAgain, please let me know if you have any thoughts on this or guidance to offer. It is greatly\nappreciated!\nRegards,\n-Breanna\nFrom: Daniel Stoehr [mailto:info@danielstraining.com]\nSent: Wednesday, August 5, 2020 12:56 PM\nTo: INFOCNTR (PHMSA) \nSubject: Request Letter of Interpretation for Classification of COVID-19 Samples\nCAUTION: This email originated from outside of the Department of Transportation (DOT). Do not click on links or\nopen attachments unless you recognize the sender and know the content is safe.\nI request a letter of interpretation for the following.\nA person will offer for transportation by highway the specimens collected from persons during\nroutine testing for the SARS-CoV-2 virus. Per CDC guidance referenced by USDOT/PHMSA,\nthe patient specimens will be classified as a Category B infectious substance (Division 6.2)\nhazardous material. The patient samples will be offered for transportation and transported in a\nmanner eligible for the exception from full regulation at 49 CFR 173.134(b)(10).\nThe USDOT/PHMSA Safety Advisory Notice for the Transportation of COVID-19 Diagnostic\nSamples issued June 19, 2020 seems to indicate that patient specimens should be classed and\ndescribed as \"UN3373, Biological substance, Category B, 6.2\". It also provides guidance on\nthe correct packaging and hazard communication for transportation of the patient specimens\nsubject to full regulation pursuant to 49 CFR 173.199.\nHowever, the Safety Advisory Notice also contains the following sentence, \"To ensure their\nsafe transportation, SARS-CoV-2 diagnostic samples must be packaged and offered for\n\n<<>>\n\ntransportation in conformity with the applicable requirement in the HMR for Category B\ninfectious substances.\" The use of the word \"applicable\" leaves open the possibility that an\napplicable requirement of the HMR - such as the exception at 49 CFR 173.134(b)(10) is\nacceptable. Also, the Safety Advisory Notice refers to exceptions to the HMR for Category B\ninfectious substances; specifically, those of 49 CFR 173.134(b) and (c) and does not forbid\ntheir use.\nMy question: does the above-referenced Safety Advisory Notice (while in effect) preclude a\nperson from offering for transportation in commerce a COVID-19 diagnostic sample (e.g.,\nnasal swabs, vials of sputum, and other related items) as a Category B infectious substance\n(Division 6.2) subject to the exception from regulation at 49 CFR 173.134(b)(10)?\nDaniel Stoehr\nDaniels Training Services, Inc.\n815.821.1550\nInfo@DanielsTraining.com\nwww.DanielsTraining.com\nSubscribe to my Monthly Newsletter\nHow'd I do? Click here to write a review.","truncated":false,"body_characters":6709}