{"operation":"document","citation":"19-0014","title":"Attorney at Law — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2019-09-18","effective_on":null,"summary":"19-0014 response to Attorney at Law concerning 173.134.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-19-0014.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-19-0014.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-19-0014","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/docs/standards-rulemaking/hazmat/interpretations/72476/190014.pdf","body":"<<>>\n\nU.S. Department\nof Transportation\nPipeline and Hazardous\nMaterials Safety\nAdministration\nSeptember 18, 2019\n1200 New Jersey Avenue, SE\nWashington, DC 20590\nLawrence W. Bierlein\nAttorney at Law\n1101 30th Street NW\nSuite 500\nWashington, DC 20007\nReference No. 19-0014\nDear Mr. Bierlein:\nThis letter is in response to your February 11, 2019, email requesting clarification of the\nHazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to medical devices.\nSpecifically, you ask whether an offeror can utilize the exception provided in\n§ l 73.134(b)(12)(i) for used medical devices shipped for refurbishment when some of the\ndevices may be \"rejected\" as determined by the consignee's facility and then disposed of.\nThe exception provided in§ 173.134(b)(12)(i) is for laundry or medical equipment conforming\nto the regulations of the Occupational Safety and Health Administration of the Department of\nLabor in 29 CFR 1910.1030 and includes medical equipment intended for use, design, and\nrefurbishment. This exception does not apply to medical equipment being transported for\ndisposal. Once an offeror determines the laundry or medical equipment is not capable of being\ncleaned or refurbished and is to be disposed of, the provision in§ l 73.134(b)(l2)(i) cannot be\nutilized. Therefore, an offeror cannot knowingly ship hazardous material meant for disposal\nunder the provision in§ l 73.134(b)(l2)(i). Please note that no person may offer or accept a\nhazardous material for transportation in commerce unless the hazardous material is properly\nclassed, described, packaged, marked, labeled, and in condition for shipment.\nI hope this information is helpful. Please contact us if we can be of further assistance.\nSincerely,\nT. Glenn Foster\nChief, Regulatory Review and Reinvention\nStandards and Rulemaking Division\n\n<<>>\n\n~\n~/70./01 (_k)/'c\nI 9 -- o«Y:\nDodd, Alice (PHMSA) From: Kelley, Shane (PHMSA)\nSent: To: Cc:\nSubject:\nAttachments:\nMonday, February 11, 2019 11:45 AM\nHazmat Interps; January, Ikeya CTR (PHMSA); Dodd, Alice (PHMSA)\nFoster, Glenn (PHMSA); DerKinderen, Dirk (PHMSA); Nickels, Matthew (PHMSA)\nFwd: Request for interpretation of Sec 173.134(b)(12)\nSterilmed request for interpretation.docx\nPlease log for response. Thank you\nFrom: larry hazmat-lawyer.com \nSent: Monday, February 11, 2019 11:26 AM\nTo: Kelley, Shane (PHMSA)\nSubject: Request for interpretation of Sec 173.134(b)(12)\nShane, please see the attached request for an interpretation to enable Sterilmed to continue shipping certain medical\ndevices. Please let me know if you have any questions on this request, or if I should provide more information. Thank\nyou.\nLarry Bierlein, (202) 631-3222\n1\n\n<<>>\n\nLAWRENCE W. BIERLEIN\nFebruary 11, 2019\nMr. Shane Kelley, Director\nPHMSA Standards & Rulemaking, PHH-10\nU.S. Department of Transportation\nWashington, DC 20590\nRe: Request for interpretation of 49 CFR 173.134(b)(12)\nDear Mr. Kelley:\nMy client Sterilmed, Inc., is a subsidiary of Johnson & Johnson engaged in refurbishing single-\nuse medical devices. The company is authorized by the Food & Drug Administration to\nrefurbish used devices and to market those devices back to hospitals. Devices used in surgery\nare collected in a Sterilmed program conforming to the Occupational Safety & Health\nAdministration bloodbome pathogen standard in 29 CFR 1910.1030. This OSHA standard\nprescribes requirements for employee training and the packaging, marking, labeling, and\nhandling of articles that may be contaminated.\nUsed devices collected from hospitals in the U.S. and Canada are sorted, inspected, cleaned and\nrefurbished to the specifications of the original equipment manufacturer. Devices tested and\ndetermined by Sterilmed to meet these specifications are returned to hospitals for additional use,\nresulting in cost savings to the hospitals. These processes result in the rejection of certain\ndevices as no longer being equivalent to new devices. Some rejected devices are those that\nSterilmed is not capable of refurbishing, but the significant majority of rejected devices are ones\nno longer capable of being refurbished to be equivalent to new devices.\nAt the time of shipment of used devices to the Sterilmed facility, no one knows which of them\nultimately may be discarded as medical waste, although it is known that a percentage of the\ndevices will be discarded. The waste determination is made by trained and qualified\nprofessionals at the Sterilmed facility after the sorting, inspection, and evaluation of each device.\nAn exception from certain DOT regulations in 49 CFR 173.134(b)(12)(i) describes \"Laundry or\nmedical equipment\" conforming to the OSHA bloodbome pathogen standard. This paragraph\nincludes medical devices for use, cleaning, or refurbishment. A sentence in this subparagraph\nreads: \"This exception does not apply to medical equipment being transported for disposal.\"\nPlease advise whether this quoted sentence precludes use of this exception for used medical\ndevices being transported for refurbishment, recognizing that the process will result eventually in\nsome of them being discarded. Thank you.\nSincerely,\nLawrence W. Bierlein\n1101 30lh Street, NW Suite 500\nWashinglon, DC 20007\ntel 202-625-8355\nmobile 202-631-3222\nViv1w.ha2rnat-lawyer.com\niarry@t1azn1at-lav:yer.com","truncated":false,"body_characters":5336}