{"operation":"document","citation":"07-0057","title":"Stericycle, Inc. — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2007-03-19","effective_on":null,"summary":"07-0057 response to Stericycle, Inc. concerning 173.134.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-07-0057.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-07-0057.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-07-0057","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2007/070057.pdf","body":"<<<PAGE 1>>>\n\n400 Seventh Street, S.W.\nWashington, D.C. 20590\nHazardous Materiais Safety\nPipeline and\nAdministration\nMAR\n19 2007\nStericycle, Inc.\nMs. Selin Hoboy\nRef. No. 07-0057\n2333 Waukegan Road\nBannockburn, Illinois 60015\nDear Ms. Hoboy:\nThis responds to your March 9, 2007 letter requesting clarification of the requirements for\nFans 171-80: Specially, youst about the caption Ms 173l Rey apie MR: 49 CER\ntransportation of waste cultures and stocks and for clarification of the types of ma erials that may\nbe transported on the same vehicle as waste cultures and stocks in accordance with the exception.\nThe exception in § 173.134(c)(2) permits a waste stock or culture of a Category B infectious\nsubstance to be offered for transportation and transported as a regulated medical waste when it is\npackaged in a rigid non-bulk packaging conforming to the general packaging requirements of\ntransported by a private or contract carrier in a vehicle used exclusively to transport regulated\n8§ 173.24 and 173.24a and packaging requirements specified in 29 CFR 1910.1030 and\nmedical waste. As your letter notes, in a final rule published [insert date] under docket number\nHM-226A, we amended the language in this section to insert the phrase \"used exclusively to\ntransport regulated medical waste\" in place of the phrase \"dedicated to the transportation of\nregulated medical waste\"\nThe change in terminology in § 173.134(c)(2) was intended to be a non-substantive editorial\nchange to standardize terminology used throughout the HMR. The terms \"dedicated\" and \"used\ntransport of radioactive materials. As used in the HMR, the terms \"dedicated\" and \"used\nexclusively\" are synonymous. \"Exclusive use\" is not defined in the HMR, for other than\nexclusively\" mean the vehicle is used for the transportation of a single commodity or class of\ncommodities.\nAccording to your letter, it is difficult to identify and segregate waste cultures and stocks from\nindicate that waste generators may ask Stericyle to transport other types of medical waste in\nPlant and animal waste regulated by the Animal and Plant Health Inspection Service,\nU.S. Department of Agriculture;\n070057\n173.134\n\n<<<PAGE 2>>>\n\n• Waste pharmaceutical materials;\n• Laboratory and recyclable wastes, such as fixer/developer, amalgam, lead foil, and\ndisinfectant materials;\n• Infectious substances, including Category A infectious substances, that have been treated\nto eliminate or neutralize pathogens;\n• Forensic materials being transported for final destruction;\n• Rejected or recalled health care products; and\n• Documents intended for destruction in accordance with HIPAA requirements.\nof medical waste.\nYou indicate that all these waste materials are transported to facilities designated for the disposal\nstocks to be transported as regulated medical waste in a rigid non-bulk packaging conforming to\nAs described above, the exception in § 173.134(c)(2) permits Category B waste cultures and\nvehicle used exclusively to transport regulated medical waste. An exclusive-use vehicle is one\ncertain general packaging requirements when transported by a private or contract carrier in a\nused for the transportation of a single commodity or class of commodities; transportation in an\nexclusive-use vehicle in accordance with the exception prevents inadvertent contamination of\nother types of materials, including non-medical waste materials. The operations you describe for\nthe transportation of waste cultures and stocks appear to meet the intent of this exception. While\nthe materials you transport on the same vehicle as waste cultures and stocks are not regulated\nmedical waste, as that term is defined in the HMR, all the materials are considered medical waste\nand are transported to facilities designated by local authorities and designed for the disposal of\nmedical waste.\nFurther, under § 173.134(c)(2), you may transport medical or clinical equipment and laboratory\nproducts on the same vehicle as the waste cultures and stocks covered by the exception, provided\nthey are properly packaged and secured against exposure or contamination. The term\n\"laboratory products\" is not defined in the HMR. However, the materials you describe are\ngenerated from laboratories and health care facilities and, thus, may be considered laboratory\nproducts for the purposes of the exception.\nTherefore, it is the opinion of this Office that the transportation operation you describe is\nconsistent with the terms of the exception in § 173.134(c)(2). Therefore, you may transport the\ncultures and stocks.\ntypes of medical waste described in your letter on the same vehicle you use to transport waste\n\n<<<PAGE 3>>>\n\nI hope this information is helpful. Please let me know if I can be of further assistance.\nSincerely,\nSusan corsk\nRegulations officer\nOffice of Hazardous Materials\nStandards\n\n<<<PAGE 4>>>\n\nStericycle ®\nExperts in Infection Control and\nHealthcare Compliance Services\nMarch 9, 2007\nhorsku\n{|73. 13\nMr. Edward Mazzullo, Director\nOffice of Hazardous Materials Standards\nExceptions for Medical Waste\nPHH-10\n400 Seventh Street, S. W\n07-0051\nWashington, DC 20590\nRE: FINAL RULE HM 226A - INTERPRETATION OF \"EXCLUSIVE\" MEDICAL\nWASTE CARRIER\nUNDER 49 CFR 173.134\nDear Mr. Mazzullo:\nI am writing in reference to a recent language change under Final Rule HM 226A. In this\nfinal rule there is a section relating to the transportation of regulated medical waste.\nSpecific section reference is 49 CFR 173.134 (c)(ii)(2) \"[Category B waste culture or\nstock] transported as regulated medical waste when it is packaged in a rigid non-bulk\npackaging requirements under 29 CFR 1910.1030 and transported by a private or contract\npackaging conforming to the general packaging requirements of 173.24 and 173.24a and\ncarrier in a vehicle used exclusively to transport regulated medical waste.\" Prior to this\nchange the term \"dedicated\" was used instead of\n\"exclusively\". Based on the literal\ninterpretation of these regulations it would mean that materials other than regulated\nmedical waste could not be on the vehicle at the same time.\nAlthough, we recognize that the mixed cultures and stock materials which may be present\nin the containers is minimal and often more specifically from lab type environments, the\npotential still exists. It is also typical that wastes generated in these environments are\nthe way that generators package their waste to take advantage of this exception, it would\npretreated prior to being disposed of in the regulated medical waste.\nHowever, due to\nbe difficult to ensure exclusivity for these materials alone.\nWe are requesting clarification that this new term does not change the intent of the\nregulation.\ndedicated to the transport of regulated medical waste, other materials could be present on\nPrior to this, the interpretation was that as a private carrier, primarily\nthe vehicle. However, there are other waste streams that are transported as a service to\ngenerators for the safe and efficient transport of their waste materials. All drivers and\nthese other waste materials. This provides generators with an efficient anc compliant\nemployees are fully trained on the proper handling, transport and emergency response to\noption for transporting their wastes. Other such wastes which generator's may request to\nbe transported that are not necessarily regulated medical waste by definition may include:\n• US Department of Agriculture - Animal and Plant Health Inspection Service -\nand are required to have specific packaging, documentation and destruction\nWastes defined under 7 CFR as regulated garbage, including plant and an:mal waste,\nrequirements\n2333 Waukegan Road, Suite 300 • Bannockburn, IL 60015 • • • www.stericycle.ccm\nStericycle, Inc.\n\n<<<PAGE 5>>>\n\n• Waste pharmaceuticals - pharmaceutical materials which are meant for final\naccordance with regulations and separately documented as required\ndestruction and no longer have value by manufacturer definition; packaged in\n• Lab and Recyclable wastes - for example fixer/developer for recycling, amalgam for\nrecycling, lead foil for recycling, disinfectant materials etc. - Packaged in accordance\nwith regulations and separately documented as required\n• Treated Category A infectious substances which generators chose to over classify\nDocuments for destruction under HIPAA requirements\n• Evidence materials - non weapon law enforcement materials sent for final\ndestruction\n• Off specification products from manufacturers due to rejection or recal., normally\nconsidered solid waste, which is transported for destruction\nCurrent needs of the industry and generators are that other waste streams, which are also\nclassitied, marked and packaged appropriately, could be transported with regulated\nresponsible disposal of these materials.\nWe would like to clarify that these additional waste materials can be transported with\nquestions at 847-943-6685/shoboy@stericycle.com.\nSincerely,\nSelin Hoboy\nStericycle, Inc\nCC:\nDeputy Robert A. Richard - Deputy Associate Administrator for Hazardous\nMaterials Safety\nJoseph Solomey - Assistant Chief Counsel for Hazardous Materials Safety Office\nof Chief Counsel.\nAlice Jacobson, Medical Waste Institute","truncated":false,"body_characters":9167}