Transportation Development Group LLC — Hazardous Materials Safety Interpretation

Page 11200 New Jersey Avenue, SE Washington, DC 20590 U.S. Department of Transportation Pipeline and Hazardous Materials Safety Administration August 7, 2025 Jim Powell President Transportation Development Group LLC 190 W. Continental Rd, Suite 216-401 Green Valley, AZ 85614 Reference No. 25-0063 Dear Mr. Powell: This letter is in response to your April 21, 2025 email requesting clarification of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to the transportation of Division 6.2 (Infectious substance) materials. Specifically, you requested clarification on the transportation of HIV+ blood for the purposes of an autologous blood transfusion and whether it is subject to the requirements of the HMR. Section 173.134(b) lists materials not subject to the HMR as Division 6.2 infectious substances. This includes, in accordance with § 173.134(b)(7), blood, regardless of whether it contains an infectious substance, collected for the purposes of a blood transfusion. I hope this information is helpful. Please contact us if we can be of further assistance. Sincerely, Dirk DerKinderen Chief, Standards and Development Branch Standards and Rulemaking Division#

Page 2Horne, T. 25-0063 From: INFOCNTR (PHMSA) To: Dodd, Alice (PHMSA) Cc: Hazmat Interps; Baker, Yul (PHMSA) Subject: FW: Interpretation Request - Shipping Cat B Blood as Non-Regulated for Autologus Transfusion Date: Monday, April 21, 2025 15:42:04 Attachments: PHMSA_Interpretation_Request_Autologous_Transfusion.pdf Hi Alice, Please see the attached interpretation request. Let us know if you need anything. Sincerely, Janaye From: Jim Powell <jim@dgtraining.com> Sent: Monday, April 21, 2025 1:43 AM To: PHMSA HM InfoCenter <PHMSAHMInfoCenter@dot.gov>; INFOCNTR (PHMSA) <INFOCNTR.INFOCNTR@dot.gov> Cc: Jim Powell <jim@dgtraining.com>; Terry Poland <Terry@dgtraining.com> Subject: Interpretation Request - Shipping Cat B Blood as Non-Regulated for Autologus Transfusion 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. Please see the attached request to clarify 173.134(b)(7) which essentially exempts all blood being shipped for the purpose of transfusion, from the HMR. It is possible that a patient with a rare blood type might want to bank their own blood for a future surgery. If that patient tested positive for HIV or Hepatitis or some other blood borne pathogen, could this blood, being shipped for transfusion be shipped as non-regulated. It seems that it could. It’s not being shipped for the purpose of testing – it’s already been tested so 173.134(b)(8) would not seem to apply. I called the HMinfo center and talked with an agent so agreed that it would be not subject to the HMR but I’d feel more comfortable with an interpretation. Thank you, Jim Powell President Transportation Development Group LLC www.dgtraining.com 1-808-280-6047#

Page 3jim@dgtraining.com#

Page 4Transportation Development Group LLC 190 W. Continental Rd Ste 216-401 Green Valley, AZ 85614 1-808-280-6047 Direct | 1-800-949-4834 April 20, 2025 Pipeline Standards and Rulemaking U.S. Department of Transportation, Pipeline and Hazardous Materials Safety Administration 1200 New Jersey Avenue, SE Washington, DC 20590 Email pdf to infocntr@dot.gov Phone: 202-366-8553 Interpretation request – Autologous Transfusion with HIV+ Blood I would like to verify that if a HIV+ patient who wants to “bank” their own blood (i.e. for future surgery) and that blood for transfusion can be shipped without being considered either UN3373 or an Exempt Human Specimen. 49 CFR 173.134(b)(7) says that blood shipped for the purpose of transfusion is not subject to the HMR. It does not qualify that exception if the patient might be HIV+ or infected with some other bloodborne pathogen in Category B. The PHMSA Infectious Substance Classification Flowchart supports this as well. Here’s a recap of that flow chart: Is the material known or reasonably expected to contain an infectious pathogen? YES Does it meet the definition of a Category A infectious substance? Does it meet any of the conditions listed in §173.134(b)? YES NO (it meets 173.134(b)(7)) Not subject to the requirements of Division 6.2 materials. While the incidence of autologous transfusions is diminishing, it is still possible that a patient with a rare blood-type may want to engage in this type of storage, and if needed, shipping this blood to a surgical site. DOT Interpretation Request HIV+ Blood shipped for Autologous Transfusion.#

Page 5One final note, there is an exception in 173.134(b)(8), but that appears only relevant to blood being shipped for the purpose of testing. This is the patient’s own blood that has already been screened and is known to be HIV+ (or some other Cat B pathogen for the sake of discussion.) Can that blood, shipped for the purpose of transfusion, even though it is HIV+, be transported as not-regulated as per 173.134(b)(7). Sincerely, Jim Powell, DGSA, CDGP President Transportation Development Group LLC jim@dgtraining.com 1-808-280-6047 PS just to double-check I also looked at ICAO and the UN Recommendations and it has the same exemption: ICAO 6.3.2.3.7 Bood products Blood or blood components that have been collected for the purposes of transfusion or for the preparation of blood products to be used for transfusion or transplantation and any tissues or organs intended for use in transplantation as well as samples drawn in connection with such purposes are not subject to these Instructions. UN Model Regulations (Orange Book) 2.6.3.2.3.7 Blood or blood components which have been collected for the purposes of transfusion or for the preparation of blood products to be used for transfusion or transplantation and any tissues or organs intended for use in transplantation as well as samples drawn in connection with such purposes are not subject to these Regulations. DOT Interpretation Request HIV+ Blood shipped for Autologous Transfusion.#