{"operation":"document","citation":"98-0529","title":"Pall Corporation — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"1998-02-25","effective_on":null,"summary":"98-0529 response to Pall Corporation concerning 173.134.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-98-0529.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-98-0529.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-98-0529","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/1998/980529.pdf","body":"<<<PAGE 1>>>\n\n=\nU.S.Department\nof Transportation\n400 Seventh Street, S.W.\nWashington, D.C.\n20590\nResearch and\nAdministration\nSpecial Programs\nFEB 25 1998\nMs. Susan Morrissey\nEnvironmental Services Consultant\nPall Corporation\n25 Harbor Park Drive\nPort Washington, NY 11050\nDear Ms. Morrissey:\nThis is in response to your letter of May 5, 1997, requesting clarification of requirements for\ntransporting used medical devices and human donor blood under the Hazardous Material\nRegulations (HMR; 49 CFR Parts 171-180). You stated in your letter and in a subsequent\ntelephone conversation, on September 17, 1997, with Mr. Charles Betts of my staff that neither\nthe medical devices or the human donor blood contained known infectious agents.\nThe HMR define an \"infectious substance\" in § 173.134 (a)(1) as a viable microorganism, or its\ntoxin, which causes or may cause disease in humans or animals. This includes agents listed in 42\nCFR 72.3 of the regulations of the Department of Health and Human Services and any other\nagent that causes or may cause severe, disabling, or fatal disease. Biological products (i.e.,\nhuman donor blood) and medical equipment (i.e., used medical devices that conforms to 29 CFR\n1910.1030 of the regulations of the Occupational Safety and Health Administration of the\nDepartment of Labor) are excepted, under §§ 173.134 (b)(1)(i) and 173.134 (b) (ill)\nrespectively, from the requirements of the HIMR if the items as packaged do not contain any\nmaterial that would otherwise be subject to any other Department of Transportation hazard class.\nTherefore, based on the information you provided, it appears that the medical devices and human\ndonor blood would not be subject to the HMR.\nI hope this information is helpful. Should you have further questions, do not hesitate to contact\nuS.\n:\nSincerely,\nHotter. Mithelo\nHattie L. Mitchell, Chief\n1\nRegulatory Review and Reinvention\nOffice of Hazardous Materials Standards\n:\n\n<<<PAGE 2>>>\n\nBetto\nFile: 173.134\nPall Corporation\nSC: 133,132\n-\nPhone 516-484-3600 • FAX 516-484-3651\n25 Harbor Park Drive • Port Washington, NY 11050 • USA\nMay 5, 1997\nMr. Edward T. Mazzullo\nRSPA\nU.S. Department of Transportation\nAttention: DHM-10\n400 7* Street SW\nWashington, D.C., 20590\n-\n--\n-\n----\nRe:\nPall Corporation\nRequest for Determination of a Hazardous Material\nDear Mr. Mazzullo:\nWe are writing to your attention to request guidance on forming a hazardous\nmaterial determination for transporting: (1) returned medical devices and (2) human\ndonor blood. These medical devices are potentially infectious because they are returned\ngoods from hospitals used in patient care and may have been in contact with potentially\ninfectious materials such as human blood, platelets and intravenous fluids. The human\ndonor blood is tested and screened for infectious disease markers. Neither of these\nmaterials contain known infectious agents.\nPlease advise how these materials should be classified and packaged for transport\n/ (i1) 48 -doi;, ext theris further information that we may provide, please contact me at\nWe this it!'\nSincerely,\nPALL CORPORATION\nsusan Morrissey\nSusan Morrissey\nEnvironmental Services Consultant\n\n<<<PAGE 3>>>\n\nScientific & Laboratory Services Dept.\n)\nall Corporation • 25 Harbor Park Drive\nPort Washington, NY 11050 • USA\nMr. Edward T. Mazzullo\nU.S. Department of Transportation\nRSPA\nATTN: DHM-10\n400 7th Street SW\nWashington, DC, 20590","truncated":false,"body_characters":3405}