{"operation":"document","citation":"20-0063","title":"DNA Genotek — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2020-09-25","effective_on":null,"summary":"20-0063 response to DNA Genotek concerning 173.134, 173.22.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-20-0063.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-20-0063.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-20-0063","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/docs/standards-rulemaking/hazmat/interpretations/74416/200063.pdf","body":"<<>>\n\nU.S. Department\nof Transportation\nPipeline and Hazardous\nMaterials Safety\nAdministration\n1200 New Jersey Avenue, SE\nWashington, DC 20590\nSeptember 25, 2020\nAustin Udocor\nSenior Manager\nDNA Genotek\n3000-5000 Palladium Drive\nOttawa, ON Canada K2V 1C2\nReference No. 20-0063\nDear Mr. Udocor:\nThis letter is in response to your August 13, 2020, email requesting clarification of the\nHazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to the exception for\ninfectious substances in § 173.134(b)(11). You reference “Scenario 4” on pg. 7 of the Pipeline\nand Hazardous Materials Safety Administration (PHMSA) guidance document titled,\n“Transporting Infectious Substances Safely,” and ask specifically whether saliva samples used\nfor routine direct-to-customer genetic testing or research (e.g., ancestry or pharmacogenomics\ntesting) would apply to the scenario. In addition, you ask whether this guidance is the most\ncurrent with respect to shipping specimens.\nSection 173.134(b) provides a listing of material that is not subject to the HMR as a Division 6.2\ninfectious substance. The exception provided in § 173.134(b)(11) specifically addresses human\nor animal samples (including, but not limited to, secreta, excreta, blood and its components,\ntissue and tissue fluids, and body parts) being transported for routine testing not related to the\ndiagnosis of an infectious disease. Such routine testing includes those for drug/alcohol,\ncholesterol, blood glucose level, prostate specific antibody, testing to monitor kidney or liver\nfunction, pregnancy, or tests for diagnosis of non-infectious diseases, such as cancer biopsies,\nand for which there is a low probability the sample is infectious (emphasis added). Based on the\ninformation you provided, it is our understanding that the saliva samples are transported for\nroutine testing not related to the diagnosis of an infectious disease. However, in accordance with\n§ 173.22 of the HMR, it is the shipper’s responsibility to properly classify a material, and\ntherefore, determine if the saliva samples are eligible or not for exception from regulations under\nthe HMR.\nFurthermore, with respect to the guidance document, PHMSA revised and reissued\n“Transporting Infectious Substances Safely” in April 2020. It is our most current general\nguidance on transporting infectious substances under the HMR that is available on our website.\n\n<<>>\n\nPlease note that PHMSA has other useful information on the transportation of infectious\nsubstances at the following web link:\nhttps://www.phmsa.dot.gov/transporting-infectious-substances/transporting-infectious-\nsubstances-overview\nI hope this information is helpful. Please contact us if we can be of further assistance.\nSincerely,\nDirk Der Kinderen\nChief, Standards Development Branch\nStandards and Rulemaking Division\n\n<<>>\n\nBaker\n20-0063\nFrom: Foster, Glenn (PHMSA)\nTo: Dodd, Alice (PHMSA)\nCc: DerKinderen, Dirk (PHMSA); Kelley, Shane (PHMSA); Nickels, Matthew (PHMSA)\nSubject: FW: Shipping of Saliva samples\nDate: Friday, August 14, 2020 5:41:49 AM\nAttachments: Transporting Infectious Substances Safely.pdf\nimage005.png\nimage006.png\nAlice,\nPlease have the attached checked in as a request for a Letter of Interpretation and assign it to the\nnext Specialist in the rotation. Please note in the file that John Heneghan would like to be notified\nwhen a response is issued.\nThanks,\nGlenn\nFrom: Heneghan, John (PHMSA)\nSent: Thursday, August 13, 2020 6:09 PM\nTo: austin.udocor@dnagenotek.com; INFOCNTR (PHMSA) \nCc: Quade, William (PHMSA) ; Kochman, Benjamin (PHMSA)\n; Schoonover, William (PHMSA) ;\nHeneghan, John (PHMSA) \nSubject: FW: Shipping of Saliva samples\nAustin,\nAs you are asking for a specific interpretation of the regulations, I am forwarding your question to\nour Office of Standards who will reply back to you in a timely manner.\nWe will be in touch.\nThanks\nJohn\nJohn P. Heneghan\nDirector, Southern Region\nOffice of Hazardous Materials Safety, Field Operations\nPipeline and Hazardous Materials Safety Administration\nU.S. Department of Transportation\n230 Peachtree Street NW, Suite 2100 (PHH-46)\nAtlanta, Georgia 30303\n(: (404) 832-1135 8: John.Heneghan@dot.gov ): 678-429-2680\nWebpage: phmsa.dot.gov/hazmat\nLinkedin: www.linkedin.com/in/johnheneghan\n\n<<>>\n\nFrom: Austin Udocor [mailto:austin.udocor@dnagenotek.com]\nSent: Thursday, August 13, 2020 3:41 PM\nTo: Quade, William (PHMSA) ; Kochman, Benjamin (PHMSA)\n; Schoonover, William (PHMSA) ;\nHeneghan, John (PHMSA) \nSubject: Shipping of Saliva 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.\nDear PHMSA Team,\nI hope you are all doing well. Earlier this year, we discussed shipping of saliva samples for COVID-19\ntesting for a number of customers we were supporting.\nWe have a question with respect to the attached PHMSA Guidance, Scenario 4 on page 7.\nSpecifically, do saliva samples used for routine direct to consumer genetic testing or research e.g.\nancestry or pharmacogenomics testing fall under this category\nSecondly, is this the most current guidance with respect to specimen shipping?\nAny assistance you can provide will be helpful.\nMany thanks for your response.\nAustin\nAustin Udocor | Senior Manager, Regulatory Affairs\nDNA Genotek | Superior Samples ● Proven Performance\n3000-500 Palladium Drive, Ottawa, ON Canada K2V 1C2\naustin.udocor@dnagenotek.com | www.dnagenotek.com |\nToll-Free: 1-866-813-6354 x 2245 | Direct: 613-723-5757 x 2245 | Fax: 1-613-638-4628\nVisit our blog, The Genetic Link at https://blog.dnagenotek.com\nIf you would like to opt out of email from DNA Genotek, you can unsubscribe here.\n\n<<>>\n\nFrom: Quade, William (PHMSA) [mailto:william.quade@dot.gov]\nSent: April 30, 2020 12:20 PM\nTo: Austin Udocor ; Kochman, Benjamin (PHMSA)\n; Schoonover, William (PHMSA) \nCc: tiffany@p23labs.com; Kasia Drozd \nSubject: RE: [EUA200403] P23 Labs TaqPath SARS-CoV-2 Assay EUA\n---== Email received from external source ==--\nAustin,\nThank you for contacting us. We just want to make sure that the transportation requirements are\ngoing to be met. I will be forwarding you information to our team who will reach out this afternoon.\nThanks,\nBill Quade\nDeputy Associate Administrator for Plans and Policy\nUSDOT, PHMSA\n1200 New Jersey Ave, SE, Washington, DC 20590\nOffice: 202.366.6873 ◊ Mobile: 202.510.8276\nFrom: Austin Udocor [mailto:austin.udocor@dnagenotek.com]\nSent: Thursday, April 30, 2020 12:12 PM\nTo: Kochman, Benjamin (PHMSA) ; Schoonover, William (PHMSA)\n; Quade, William (PHMSA) \nCc: tiffany@p23labs.com; Kasia Drozd \nSubject: [EUA200403] P23 Labs TaqPath SARS-CoV-2 Assay EUA\nImportance: High\nGood Afternoon,\nWe hope you are doing well.\nOur company DNA Genotek is supporting P23 Labs in the above referenced SARS-CoV-2 Assay\nEmergency Use Authorization application currently in FDA review. DNA Genotek is the manufacturer\nof the saliva collection devices. A description of the proposed assay is provided below for context.\nP23 Lab contact Dr. Tiffany Montgomery is copied on the email.\nThe FDA reviewer included the comments below and asking that we make you all aware. Please let\nus know if you have any questions or comments.\nFDA reviewer comment:\n\n<<>>\n\n“I wanted to bring the following to your attention. For your home or self collected saliva\nspecimens under the supervision of a HCP that will be shipped to your laboratory for testing,\nwe are now asking that you contact the Department of Transportation Pipeline and\nHazardous Materials Safety Administration to make them aware that your product will be\nshipping coronavirus clinical samples. I am not sure if you or DNA Genotek would be\nresponsible for contacting the Dept of Transportation. Can you please reach out to DNA\nGenotek and discuss?”\nThe contact are provided below:\nPlease email:\nKochman, Benjamin (PHMSA) Director of Governmental,\nInternational and Public Affairs\nSchoonover, William (PHMSA) William Schoonover (Associate\nAdministrator for Hazardous Materials Safety)\nQuade, William (PHMSA) William Quade (Deputy Associate\nAdministrator for Hazardous Materials Safety).”\nDescription of the proposed assay\nThe P23 Labs, TaqPath SARS-CoV-2 assay is a RT-PCR detection assay is intended for the\nqualitative detection of nucleic acid from SARS-CoV-2 in oropharyngeal (throat) swab,\nnasopharyngeal swab, anterior nasal swab, mid-turbinate nasal swab and saliva specimens\nfrom individuals suspected of COVID-19 by their healthcare provider. Saliva Specimens have\nbeen validated for self-collection under the supervision of a health care professional (HCP)\nand professional collection by a HCP. Self-collection of saliva, under supervision of a trained\nHCP, will occur in the home, assisted living setting, at a doctor’s office, or drive through\ncollection site. All swab collections will be performed directly by a trained healthcare\nprovider in the doctor’s office or other appropriate setting. Specimens will be returned to\nthe laboratory for testing within 24 hours of collection using same-day or overnight logistics\nservices such as courier, FedEx, or UPS. Testing is limited to P23 Labs, LLC (P23), Little Rock,\nAR, that is Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a\ncertified high-complexity laboratories.\nThe safety data sheet for the saliva collection device OMNIgene·ORAL OM-505 (DNA Genotek Inc)\nis attached. Please let us know if you have any questions or comments.\nBest regards,\nAustin\nAustin Udocor | Senior Manager, Regulatory Affairs\nDNA Genotek | Superior Samples ● Proven Performance\n3000-500 Palladium Drive, Ottawa, ON Canada K2V 1C2\naustin.udocor@dnagenotek.com | www.dnagenotek.com |\nToll-Free: 1-866-813-6354 x 2245 | Direct: 613-723-5757 x 2245 | Fax: 1-613-638-4628\n\n<<>>\n\nVisit our blog, The Genetic Link at https://blog.dnagenotek.com\nIf you would like to opt out of email from DNA Genotek, you can unsubscribe here.\nThe information contained in this e-mail message and any attachment hereto is legally privileged and confidential information intended\nonly for the use of the individual(s) named above. If the reader of this message is not an intended recipient, you are hereby notified that\nany use, dissemination, distribution or copying of this e-mail message and any attachment hereto is strictly prohibited. If you have\nreceived this e-mail message in error, please immediately notify the above-noted sender by telephone and erase all copies of this\nmessage from your computer. Thank you for your cooperation.","truncated":false,"body_characters":11164}