{"operation":"document","citation":"23-0082","title":"The University of Alabama at Birmingham — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2023-12-05","effective_on":null,"summary":"23-0082 response to The University of Alabama at Birmingham concerning 173.134, 173.197.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-23-0082.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-23-0082.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-23-0082","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/docs/standards-rulemaking/hazmat/interpretations/78091/230082.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department\nof Transportation\nPipeline and Hazardous\nMaterials Safety\nAdministration\n1200 New Jersey Avenue, SE\nWashington, DC 20590\nDecember 5, 2023\nJustin Roth\nSenior Biosafety Officer\nThe University of Alabama at Birmingham\n933 19th St. S. CH19 412P\nBirmingham, AL 35294\nReference No. 23-0082\nDear Mr. Roth:\nThis letter is in response to your August 22, 2023, email requesting clarification of the\nHazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to the disposal of an\nanimal carcass (i.e., a mouse carcass) engrafted with human tissues and then infected with the\nhuman immunodeficiency virus (HIV) for therapy research. Specifically, you ask whether a\nmouse carcass used as a model to study HIV infection/viremia would be considered “a culture”\nand whether such animal carcasses must be classified as Category A waste.\nThe answer is no. “Culture” is defined in § 173.134(a)(3) to mean an infectious substance\ncontaining a pathogen that is intentionally propagated. This typically refers to pathogens\ncultivated in a growth medium. It is the opinion of this office that “culture” does not include\nanimals infected with a pathogen.\nA material is not a Category A infectious substance if it is not in a form generally capable of\ncausing permanent disability or life-threatening or fatal disease in otherwise healthy humans or\nanimals when exposure to it occurs and may appropriately be classified as a Category B\ninfectious substance under § 173.134(a)(1)(i). Category B wastes derived from biomedical\nresearch, which includes the production and testing of biological products and, in this instance,\nthese animal carcasses, would be considered “Regulated medical waste or clinical waste or (bio)\nmedical waste” and must be transported in accordance with § 173.197.\n\n<<<PAGE 2>>>\n\nNote that ultimately it would be the offeror’s responsibility to evaluate and properly classify a\nhazardous material using the criteria specified for Category A or Category B infectious\nsubstances (waste) found in § 173.134.\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<<<PAGE 3>>>\n\nCasey\n23-0082\nFrom: INFOCNTR (PHMSA)\nTo: Dodd, Alice (PHMSA)\nCc: Hazmat Interps\nSubject: FW: Request for interpretation\nDate: Monday, August 28, 2023 11:24:31 AM\nHi Alice,\nPlease see the below interpretation request.\nLet us know if you need anything.\nRegards,\n-Breanna\nFrom: Roth, Justin <jcroth@uab.edu>\nSent: Tuesday, August 22, 2023 11:16 AM\nTo: INFOCNTR (PHMSA) <INFOCNTR.INFOCNTR@dot.gov>\nSubject: Request for interpretation\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.\nHello,\nWe would like guidance on how to classify the following research waste stream:\nWe have a new investigator starting who will be using humanized mice (i.e., mice engrafted with\nhuman thymus, liver, lung, and blood stem cells) to study HIV therapies. Engrafting these human\ntissues results in mice that are reconstituted with human blood cells. This allows the mice to be\ninfected with HIV. The HIV-infected mice are used to study HIV replication, and various treatment\nstrategies for suppressing it.\nDoes the fact that the mice are used as a model to study HIV infection/viremia make the animal “a\nculture,” according to the regulations? We are trying to determine whether the carcass waste can be\ndisposed of through our regulated medical waste vendor, or if it the carcasses/waste must be\nclassified as Cat A waste, requiring the material to be autoclaved first. All other studies with RG3\nmaterials occur in BSL-3 facilities, which require all waste to be autoclaved. HIV is one of the few\nRG3 pathogens that can be studied in a BSL2 facility, so the waste streams are not autoclaved by\ndefault.\nI would really appreciate your guidance classifying this waste.\nKind regards,\n\n<<<PAGE 4>>>\n\nJustin\n____________________________________________\nJustin Roth, PhD, RBP | Senior Biosafety Officer\nEnvironmental Health & Safety, Biosafety Program\nUAB | The University of Alabama at Birmingham\n933 19th\nSt. S. | CH19 412P | Birmingham, AL 35294\nP: 205.934.7488 | F: 205.934.7487 | jcroth@uab.edu\nSafety is a part of research excellence—let’s be excellent!","truncated":false,"body_characters":4425}