{"operation":"document","citation":"25-0063","title":"Transportation Development Group LLC — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2025-08-07","effective_on":null,"summary":"25-0063 response to Transportation Development Group LLC concerning 173.134.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-25-0063.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-25-0063.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-25-0063","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/2025-08/250063.pdf","body":"<<>>\n\n1200 New Jersey Avenue, SE\nWashington, DC 20590\nU.S. Department\nof Transportation\nPipeline and Hazardous\nMaterials Safety\nAdministration\nAugust 7, 2025\nJim Powell\nPresident\nTransportation Development Group LLC\n190 W. Continental Rd, Suite 216-401\nGreen Valley, AZ 85614\nReference No. 25-0063\nDear Mr. Powell:\nThis letter is in response to your April 21, 2025 email requesting clarification of the Hazardous\nMaterials Regulations (HMR; 49 CFR Parts 171-180) applicable to the transportation of Division\n6.2 (Infectious substance) materials. Specifically, you requested clarification on the\ntransportation of HIV+ blood for the purposes of an autologous blood transfusion and whether it\nis subject to the requirements of the HMR.\nSection 173.134(b) lists materials not subject to the HMR as Division 6.2 infectious substances.\nThis includes, in accordance with § 173.134(b)(7), blood, regardless of whether it contains an\ninfectious substance, collected for the purposes of a blood transfusion.\nI hope this information is helpful. Please contact us if we can be of further assistance.\nSincerely,\nDirk DerKinderen\nChief, Standards and Development Branch\nStandards and Rulemaking Division\n\n<<>>\n\nHorne, T.\n25-0063\nFrom: INFOCNTR (PHMSA)\nTo: Dodd, Alice (PHMSA)\nCc: Hazmat Interps; Baker, Yul (PHMSA)\nSubject: FW: Interpretation Request - Shipping Cat B Blood as Non-Regulated for Autologus Transfusion\nDate: Monday, April 21, 2025 15:42:04\nAttachments: PHMSA_Interpretation_Request_Autologous_Transfusion.pdf\nHi Alice,\nPlease see the attached interpretation request. Let us know if you need anything.\nSincerely,\nJanaye\nFrom: Jim Powell \nSent: Monday, April 21, 2025 1:43 AM\nTo: PHMSA HM InfoCenter ; INFOCNTR (PHMSA)\n\nCc: Jim Powell ; Terry Poland \nSubject: Interpretation Request - Shipping Cat B Blood as Non-Regulated for Autologus Transfusion\nCAUTION: This email originated from outside of the Department of Transportation (DOT). Do\nnot click on links or open attachments unless you recognize the sender and know the content\nis safe.\nPlease see the attached request to clarify 173.134(b)(7) which essentially exempts all blood\nbeing shipped for the purpose of transfusion, from the HMR. It is possible that a patient with a\nrare blood type might want to bank their own blood for a future surgery. If that patient tested\npositive for HIV or Hepatitis or some other blood borne pathogen, could this blood, being\nshipped for transfusion be shipped as non-regulated.\nIt seems that it could. It’s not being shipped for the purpose of testing – it’s already been\ntested so 173.134(b)(8) would not seem to apply.\nI called the HMinfo center and talked with an agent so agreed that it would be not subject to\nthe HMR but I’d feel more comfortable with an interpretation.\nThank you,\nJim Powell\nPresident\nTransportation Development Group LLC\nwww.dgtraining.com\n1-808-280-6047\n\n<<>>\n\njim@dgtraining.com\n\n<<>>\n\nTransportation Development Group LLC\n190 W. Continental Rd Ste 216-401\nGreen Valley, AZ 85614\n1-808-280-6047 Direct | 1-800-949-4834\nApril 20, 2025\nPipeline Standards and Rulemaking\nU.S. Department of Transportation, Pipeline and Hazardous Materials Safety\nAdministration\n1200 New Jersey Avenue, SE\nWashington, DC 20590\nEmail pdf to infocntr@dot.gov Phone: 202-366-8553\nInterpretation request – Autologous Transfusion with HIV+ Blood\nI would like to verify that if a HIV+ patient who wants to “bank” their own blood (i.e. for\nfuture surgery) and that blood for transfusion can be shipped without being considered\neither UN3373 or an Exempt Human Specimen.\n49 CFR 173.134(b)(7) says that blood shipped for the purpose of transfusion is not subject\nto the HMR. It does not qualify that exception if the patient might be HIV+ or infected with\nsome other bloodborne pathogen in Category B.\nThe PHMSA Infectious Substance Classification Flowchart supports this as well. Here’s a\nrecap of that flow chart:\nIs the material known or reasonably expected to contain an infectious pathogen? YES\nDoes it meet the definition of a Category A infectious substance? Does it meet any of the conditions listed in §173.134(b)? YES NO\n(it meets 173.134(b)(7))\nNot subject to the requirements of Division 6.2 materials.\nWhile the incidence of autologous transfusions is diminishing, it is still possible that a\npatient with a rare blood-type may want to engage in this type of storage, and if needed,\nshipping this blood to a surgical site.\nDOT Interpretation Request HIV+ Blood shipped for Autologous Transfusion.\n\n<<>>\n\nOne final note, there is an exception in 173.134(b)(8), but that appears only relevant to\nblood being shipped for the purpose of testing.\nThis is the patient’s own blood that has already been screened and is known to be HIV+ (or\nsome other Cat B pathogen for the sake of discussion.)\nCan that blood, shipped for the purpose of transfusion, even though it is HIV+, be\ntransported as not-regulated as per 173.134(b)(7).\nSincerely,\nJim Powell, DGSA, CDGP\nPresident\nTransportation Development Group LLC\njim@dgtraining.com 1-808-280-6047\nPS just to double-check I also looked at ICAO and the UN Recommendations and it has the\nsame exemption:\nICAO 6.3.2.3.7 Bood products\nBlood or blood components that have been collected for the purposes of transfusion or for\nthe preparation of blood products to be used for transfusion or transplantation and any\ntissues or organs intended for use in transplantation as well as samples drawn in\nconnection with such purposes are not subject to these Instructions.\nUN Model Regulations (Orange Book)\n2.6.3.2.3.7 Blood or blood components which have been collected for the purposes of\ntransfusion or for the preparation of blood products to be used for transfusion or\ntransplantation and any tissues or organs intended for use in transplantation as well as\nsamples drawn in connection with such purposes are not subject to these Regulations.\nDOT Interpretation Request HIV+ Blood shipped for Autologous Transfusion.","truncated":false,"body_characters":6105}