{"operation":"document","citation":"21-0002","title":"Centers for Disease Control and Prevention (CDC) — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2021-01-08","effective_on":null,"summary":"21-0002 response to Centers for Disease Control and Prevention (CDC) concerning 173.134.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-21-0002.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-21-0002.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-21-0002","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/docs/standards-rulemaking/hazmat/interpretations/74666/21-0002.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department\nof Transportation\nPipeline and Hazardous\nMaterials Safety\nAdministration\n1200 New Jersey Avenue, SE\nWashington, DC 20590\nJanuary 8, 2021\nDr. Jeanne Santoli, M.D.\nCenters for Disease Control and Prevention (CDC)\nNCIRD/ISD/VSAB\n1600 Clifton Road, NE\nAtlanta, GA 30333\nReference No. 21-0002\nDear Dr. Santoli:\nThis letter is in response to your January 4, 2021 email and January 8, 2021, telephone call with\nseveral members of the Office of Hazardous Materials Safety, Pipeline and Hazardous Materials\nSafety Administration (PHMSA) requesting clarification of the Hazardous Materials Regulations\n(HMR; 49 CFR Parts 171-180) applicable to the classification of “wasted” or otherwise expired\nCOVID-19 vaccines. Specifically, you ask whether the unopened vaccine vials would be\nregulated as a hazardous material under the HMR for purposes of mailing them back to the\ncentralized distribution depots.\nUnder 49 CFR 173.134(b)(1) a material that does not contain an infectious substance or that is\nunlikely to cause disease in humans or animals is not subject to the requirements of the HMR as\na Division 6.2 material. In the absence of another hazardous material, unopened but expired or\notherwise “wasted” vials of COVID-19 vaccines do not meet the definition of a hazardous\nmaterial and are not subject to the HMR.\nI hope this information is helpful. Please contact us if we can be of further assistance.\nSincerely,\nShane C. Kelley\nDirector, Standards and Rulemaking Division","truncated":false,"body_characters":1498}