{"operation":"document","citation":"08-0249","title":"Stericycle, Inc. — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2009-02-24","effective_on":null,"summary":"08-0249 response to Stericycle, Inc. concerning 173.21, 173.22, 173.24.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-08-0249.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-08-0249.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-08-0249","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2008/080249.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department of Transportation\nPipeline and Hazardous Materials\nSafety Administration\n1200 New Jersey Ave, S.E.\nWashington, D.C. 20590\nMr. Dan Fadgen\nStericycle, Inc.\n103 Brannon Drive\nCanton, GA 30115\nReference No. 08-0249\nDear Mr. Fadgen:\nThis is in response to your recent e-mail to two of our enforcement officers concerning\nrequirements in the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) that\napply to the transportation of hazardous wastes. Your letter was directed to the Office of\nHazardous Materials Standards for reply. You ask if incompatible Resource Conservation\nand Recovery Act (RCRA) pharmaceutical waste, such as oxidizers and corrosives, may be\nplaced in the same package either in separate inner packagings or commingled without inner\npackagings. Your questions are paraphrased and answered in the order provided.\nQ1. A typical hospital pharmacy inventory includes pharmaceuticals that meet the definition\nof Class 3 (flammable liquid), Class 2.1 (flammable gas), Class 2.2 (non-toxic, non-\nflammable gas), Division 5.1 (oxidizer), Division 6.1 (poisonous), and Class 8 (corrosive)\nmaterials. When transported as wastes, the materials must conform to RCRA regulations. If\nthe hazard class of each pharmaceutical is not identified and segregated prior to packaging for\ntransport, how can the generator or transporter (carrier) ensure that these materials are not\ncapable of reacting dangerously with each other, causing combustion, or any of the other\nreactions prohibited under 5 173.21(e) or 5 173.24(e)(4) of the HMR?\nAl. In accordance with 5 173.22 of the HMR, it is the shipper's responsibility to properly\nclass a hazardous material and assign it a proper shipping name from the Hazardous Materials\nTable (HMT; 5 172.101). It is also the shipper's responsibility to segregate incompatible\nhazardous materials before offering them for transportation in commerce and to determine if\nany dangerous reactions can occur. See 5 173.21(e). Thus, the shipper of pharmaceutical\nwaste must ascertain whether the waste materials will react dangerously with each other or\ncause combustion; a dangerous evolution of heat; evolution of flammable, poisonous, or\nasphyxiant gases or vapors; or form an unstable or corrosive material. If so, the materials\nmay not be transported in a single packaging.\nAlthough the HMR place primary responsibility on the shipper, or \"person who offers,\" to\nproperly class and communicate the hazard of a hazardous material, a carrier may be held\nresponsible for non-compliance with applicable requirements to the extent that the carrier\nknows, or should have known, that a material offered for transportation is hazardous. A\ncarrier may rely on information provided by the shipper, unless the carrier knows, or a\n\n<<<PAGE 2>>>\n\nreasonable person, acting in the circumstances and exercising reasonable care, would have\nknowledge that the information provided is incorrect.\nQ2. Pharmaceutical waste typically takes the form of partial vials (without safety seal),\nampoules, partial syringes, partial IV bags, loose tablets, and capsules. How can the shipper\nensure that there will be no dangerous reaction if these materials are shipped in a single\ncontainer or packaging?\nA2. Under 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 $5 173.21(e) and 173.24(e)(4). Shippers may use a variety of methods to\ndetermine whether or not a hazardous material will react dangerously with other materials in a\npackaging, including testing or similar analysis, experience, information from a Material\nSafety Data Sheet, or information from publications or reference material pertaining to\nchemicals and their interactions.\nIf the materials and method your company wants to use, such as randomly combining\nhazardous waste pharmaceuticals in one package, do not conform with the existing HMR\nrequirements, your company may wish to seek authorization to transport these materials under\nthe terms of a special permit. The procedures for submitting an application for a special\npermit are prescribed in 49 CFR 107.105. Please note the application must contain sufficient\ninformation to demonstrate that, if a special permit is issued, a level of safety will be achieved\nthat is equal to or greater than that required under the HMR.\nQ3. Would combining RCRA hazardous and non-hazardous pharmaceuticals consisting of\npartial vials, partial syringes, partial IV bags, loose tablets and capsules, etc., meet the\nrequirement stated in PHMSA's letter of March 21, 2008 (Reference No. 08-0035):\n\"provided these materials are not capable of reacting dangerously with each other or causing\ncombustion.. . .\"? If not, must RCRA hazardous pharmaceutical waste be segregated and\npackaged?\nA3. The materials you describe would be subject to the compatibility requirements discussed\nin our March 21, 2008 letter and prescribed in several sections of the HMR, including\n$5 173.21(e) and 173.24(e)(4), and 173.24a(c). See Answer A2.\nI hope this satisfies your request.\nSincerely, ,\nHattie L. Mitchell\nChief, Regulatory Review and Reinvention\nOffice of Hazardous Materials Safety\n\n<<<PAGE 3>>>\n\nUrnonmn Page 1 of 2\nDrakeford, Carolyn <PHMSA>\nFrom: IMitchell, Hattie <PHMSA>\nSent: Tuesday, October 07,2008 12:57 PM\nTo : Edmonson, Eileen <PHMSA>\nCc: Drakeford, Carolyn <PHMSA>\nSubject: FW: FL DEP - Oct 16 Meeting: Clarification Requested\nAttachments: DOT Letter - FL DEP.pdf\nFrom: Fadgen, Dan [mailto:DFadgen@STERICYCLE.com]\nSent: Thursday, October 02, 2008 2:28 PM\nTo: Razny, Mark <PHMSA>; Stevens, William <PHMSA>\nSubject: FL DEP - Oct 16 Meeting: Clarification Requested\nGentlemen,\nPlease excuse this lengthy email but as you both are aware, FL DEP has formed a Biomedical-Pharma Technical\nAdvisory Committee to assist in developing curriculum on hazardous pharmaceutical waste management for FL\nDEP's distribution to FL health care providers including hospitals, cancer treatment centers and, nursing homes.\nThe next committee meeting is scheduled for Oct. 16th, at Gaylord Palms Resort Hotel in Kissimmee, FL.\nThis email requests clarification on U.S. DOT regulations concerning segregation of hazardous materials\n(including pharmaceuticals) due to confusion arising out of the Aug. 27Ih committee meeting. Unfortunately the\nFL DOT representative at the August 27th committee meeting was seemingly unknowledgeable on this matter and\nfailed to provide clarification on this issue.\nMr. Barry Fernandez of Clean Fuels and, a second committee member representing HWS (Hazardous Waste\nServices), presented the attached letter from Hattie Mitchell, U.S. DOT, as documentation of their understanding\nthat all RCRA hazardous pharmaceutical waste generated by a hospital can be commingled in a common\ncontainer for transport. Clean Fuels and HWS are reportedly directing FL hospitals to commingle RCRA\nhazardous and RCRA non-hazardous pharmaceutical waste into common containers (without identification or\nsegregation of RCRA hazardous or incompatible RCRA hazardous pharmaceuticals - oxidizers & corrosives) and\nare transporting the commingled containers over public highways.\nMr. Fernandez's understanding of Ms. Mitchell's letter is directly counter to my understanding of consistent\ninterpretations of U.S. DOT regulations on segregation of hazardous materials (including pharmaceutical waste)\nincluding: a 7/16/08 response to an email inquiry submitted to the U.S. DOT Hazardous Materials Information\nCenter, plus verbal interpretations received from David Clark, U.S. DOT NE Region Office, Laura Kwilinski,\nU.S. DOT Western Regional Office and, phone conversations with both of you. All cited interpretations\nconsistently specify that hazardous materials (including RCRA hazardous pharmaceuticals), must be segregated\nand packaged per U.S. DOT'S Segregation Table for Hazardous Materials (1 74.81).\nMs. Mitchell's statement that \"Under the HMR, shippers may combine hazardous materials with other hazardous\nor non-hazardous materials in the same package provided these materials are not capable of reacting\ndangerously with each other or causing combustion.. ..\" Seemingly assumes (1) that all of the hazardous\npharmaceutical materials are chemically compatible and, (2) that the individual item containers will not break or\nleak.\n(1) A typical hospital's pharmacy inventory includes pharmaceuticals that when declared waste are RCRA\nhazardous include: Class 3 - Flammable liquids, Class 2.1 - Flammable gas, Class 2.2 - Non-toxic, non-\nflammable gas, Class 5.1 - Oxidizers, Class 6.1 - Poisonous Liquids and, Class 8 - Corrosive liquids.\nQUESTION: Unless the hazardous Rx waste is identified and segregated prior to packaging for\n\n<<<PAGE 4>>>\n\nPage 2 of 2\ntransport, how can the generator or transporter assure \"these materials are not capable of reacting\ndangerously with each other or causing combustion ...\" ?\n(2) Pharmaceutical waste typically takes the form of partial vials (without safety seal), ampoules, partial\nsyringes, partial IV bags and loose tablets and capsules.\nQUESTION: How can such items be randomly thrown into a common container without packaging\nsafe guards and there be assurance of no leaking or breaking - thus resulting in a potential\ndangerous reaction?\nOBSERVATION: During a recent 4 month study at a 208 bed hospital, Stericycle inspected the contents\nof 269 8gal and 17gal containers used for satellite accumulation of compatible pharmaceutical waste and\nfound free liquids in 14% of the containers.\nCLARIFICATION REQUESTED:\n(1) Would the combining of RCRA hazardous and RCRA non-hazardous pharmaceuticals consisting of\npartial vials, partial syringes, partial IV's, loose tablets & capsules etc., meet the requirement stated in\nMs. Mitchell's letter re: \"provided these materials are not capable of reacting dangerously with each other\nor causing combustion.. . .\"?\n(2) If not, must RCRA hazardous pharmaceutical waste be segregated and packaged?\nU.S. DOT PARTICIPATION:\nWill someone from U.S. DOT will be at the Oct. 16th FL DEP Biomedical-Pharma Technical Advisory\nCommittee meeting to clarify this issue? If so, who will be present?\nI respectfully await your response.\nDan Fadgen\nStericycle, Inc.\n103 Brannon Drive\nCanton, GA 30 1 1 5\nOffice: (770) 75 1-7589\nMobile: (404) 372-7485\ndfadgen@stericycle.com\nCONFIDENTIALITY NOTICE: The information in this Email is confidential and may be\nprivileged. This Email is intended solely for the named recipient or recipients. If you are not the\nintended recipient, any use, disclosure, copying or distribution of this Email is prohibited. If you\nare not the intended recipient, please inform us by replying with the subject line marked \"Wrong\nAddress\" and then deleting this Email and any attachments. Stericycle, Inc. uses regularly\nupdated anti-virus software in an attempt to reduce the possibility of transmitting computer\nviruses. We do not guarantee, however, that any attachments to this Email are virus-free.","truncated":false,"body_characters":11254}