{"operation":"document","citation":"08-0035","title":"BD Medical - Medical Surgical Systems — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2008-03-24","effective_on":null,"summary":"08-0035 response to BD Medical - Medical Surgical Systems concerning 173.197, 173.21, 173.24.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-08-0035.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-08-0035.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-08-0035","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2008/080035.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department\nof Transportation\nPipeline and Hazardous\nMaterials Safety\nAdministration\nMAR 2 4 2008\n1200 New Jersey Avenue, SE\nWashington, D.C. 20590\nMr. Lane Arbittier\nDirector, Quality Assurance and Regulatory Affairs\nBD Medical - Medical Surgical Systems\n4665 North Avenue\nOceanside, CA 92056\nReference No. 08-003 5\nDear Mr. Arbittier:\nThis is in response to your January 14,2008 e-mail asking how hospitals may properly\npackage drugs, chemicals (including those contained in vials, syringes, intravenous tubing,\nand intravenous bags), and infectious substance wastes in one package and transport them for\ndisposal under the Hazardous Materials Regulations (HMR; 49 CFR Parts 1 71 -1 80).\nSpecifically, you ask if hospitals may combine these materials in one \"super\" package at the\nPacking Group I level without having to comply with the HMR's segregation requirements,\nwhat design features this package should have, and what materials may and may not be\ncombined.\nUnder the HMR, shippers may combine hazardous materials with other hazardous or non-\nhazardous materials in the same package provided these materials are not capable of reacting\ndangerously with each other or causing combustion; a dangerous evolution of heat; evolution\nof flammable, poisonous, or asphyxiant gases or vapors; or forming an unstable or corrosive\nmaterial. See Q Q 1 73.2 1 (e) and 1 73.24(e)(4). Additional requirements regarding the\ninteraction of different hazardous materials within one package, with their packaging\nmaterials, and within a transport vehicle are prescribed in 8 173.24(b), the remaining\nparagraphs in $5 173.24(e), and 173.24a(a) and (c), 173.24b, 174.81, 175.78, as well as\nSubpart D of Part 176, and Subpart C of Part 177.\nIf the materials and method a hospital wants to use, such as a super \"all purpose\" package to\ncombine and ship these materials, do not conform with the existing HMR requirements, the\nhospital may wish to seek authorization to transport these materials under the terms of a\nspecial permit. The procedures for submitting an application for a special permit are\n\n<<<PAGE 2>>>\n\nprescribed in 5 107.105. Please note the application must contain sufficient information to\ndemonstrate that, if a special permit is issued, a level of safety will be achieved that is equal to\nor greater than that required under the HMR.\nI hope this satisfies your request.\nSincerely,\n~ & i e L. Mitchell\nChief, Regulatory Review and Reinvention\nOffice of Hazardous Materials Standards\n\n<<<PAGE 3>>>\n\n.\nPackaging Requirements for Hospital Waste\nDrakeford, Carolyn <PHMSA>\nFrom: Edmonson, Eileen cPHMSA>\nSent: Wednesday, February 06, 2008 1:00 AM\nTo: Drakeford, Carolyn <PHMSA>\nSubject: FW: Letter Concerning Packaging Requirements for Hospital Waste\nAttachments: pic25329.gif\nFrom: Lane-Arbittier@bd.com [mailto:Lane-Arbittier@bd.com]\nSent: Mon 1/14/2008 9:48 PM\nTo: Edmonson, Eileen <PHMSA>\nSubject: Packaging Requirements for Hospital Waste\nEileen,\nBD is a manufacturer of sharps containers and we periodically get requests\nfrom our customers for hospital generated hazardous waste containers.\nHospitals would like to segregate waste at the source in the hospital in\nthe most efficient and cost effective manner possible. At the same time,\nthey want to transport the hazardous waste in containers that meet the\nhazardous materials transportation regulations. It might be most cost\neffective to utilize in-hospital containers (lower cost plastic containers)\nand then put these containers into different containers (metal drums?)\ndesigned for transport on the road.\nBased on my somewhat limited knowledge of all EPA and DOT regulations\nrelated to storage and transport of hospital waste, it seems to me that the\nhospitals are supposed to be segregating each drug, chemical and infectious\nwaste that they need to dispose. Unfortunately, it is not practical or\naffordable for a hospital to have a different container for each hazardous\nwaste in every section of the hospital. Recently, hospital waste\nsegregation has grown to be a bigger issue because hospitals have become\nmore aware that it is unacceptable to pour many unused drugs down the\ndrain. I've heard that some hospitals have begun using plastic containers\nlabeled \"RCRA Hazardous Waste\" with a UN packing Group I1 code on the\nlabel and combining multiple drugs and chemicals (vials, syringes, IV\ntubing, IV bags) into one container. I wonder if this practice complies\nwith the DOT regulations.\n1 heard from Jennifer Harris at Lion Technologies (973-383-0800) that the\nEPA might be thinking of establishing a practical guidance for in-hospital,\ntemporary storage of hazardous materials. It might offer some practical\nalternatives to segregating each hazardous material.\nI wonder if there are \"super packages\" that we (BD and DOT) could define\nfor our customers. These \"super packages\" might allow hospitals to combine\ncertain drugs, chemicals and infectious wastes in the same\npackagelcontainer. In other words, if the hospital had a container that\nmet the Packing Group I labeling and functional test requirements, could\nthe hospital combine certain drugs, chemicals or infectious wastes and be\nacceptable for transport on the road? If so, could you help me understand\nwhich drugs, chemicals and infectious wastes could be combined? Could you\nalso help me understand what design features a DOT compliant \"super\npackage\" should have, such as a water tight primary package and a secondary\npackage?\n\n<<<PAGE 4>>>\n\nPackaging Requirements for Hospital Waste\nPage 2 of 2\nIn summary, I would appreciate your help in offering recommendations for:\n1. Combining hospital wastes into convenient groups of drugs, chemicals and\ninfectious wastes\n2. Defining the DOT package requirements to properly transport them\nThe ultimate goal is to make it easier for hospital personnel to comply\nwith the hazardous material transportation regulations.\nThanks,\nLane\n(Embedded image moved to file: pic25329.gif)\nLane Arbittier\nDirector / Quality Assurance and Regulatory Affairs\nBD Medical - Medical Surgical Systems\n4665 North Avenue, Oceanside, CA 92056 USA\ntel: 760-63 1-6520\nE-mail: Lane-Arbittier@BD.com Website: www.bd.com\nIMPORTANT MESSAGE FOR RECIPIENTS N THE\nU.S.A.:\nThis message may constitute an advertisement of\na BD group's products or services or a\nsolicitation of interest in them. 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