{"operation":"document","citation":"13-0077","title":"Bellevue Hospital Center — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2013-07-31","effective_on":null,"summary":"13-0077 response to Bellevue Hospital Center concerning 173.134, 173.24, 173.24a.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-13-0077.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-13-0077.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-13-0077","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2013/130077.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department\nof Transportation\nPipeline and Hazardous\nMaterials Safety\nAdministration\n1200 New Jersey Avenue, SE\nWashington, D.C. 20590\nMr. Kieran Toale\nIndustrial Hygenist\nand Haz Mat Coordinator\nSafety Department\nBellevue Hospital Center\n462 First Avenue, Admin. Bldg., Room 742\nNew York, NY 10016\nReference No. 13-0077\nDear Mr. T oale:\nThis is in response to your March 20,2013 e-mail, which was forwarded to this Office on\nApril12, 2013, and your May 15, 2013 telephone conversation with a member of my staff\nconcerning how to describe pharmaceutical wastes that are transported from your hospital's\nhealthcare clinic under the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180).\nIn your letter, you state that when transported from your hospital, these wastes are divided\ninto two categories: those regulated by the Environmental Protection Agency (EPA) that are\ndescribed as a hazardous waste, and everything else that is described as \"UN 3291, Regulated\nmedical waste, n.o.s., 6.2 (infectious), PG II.\" You also state these wastes typically meet one\nor more of the following hazard classes or divisions: 2.1 (flammable gas), 2.2 (non-\nflammable gas), 3 (flammable liquid), 5.1 (oxidizer), 5.2 (organic peroxide), 6.1 (poisonous),\n8 (corrosive), and 9 (miscellaneous), but rarely contain a Division 6.2 (infectious) material.\nIn addition, you state the wastes are not regulated as hazardous substances under the EPA's\nResource Conservation and Recovery Act. You ask if your understanding is correct that\nwastes that do not meet the Division 6.2 hazard class may not be offered for transportation\ndescribed as \"UN 3291, Regulated medical waste, n.o.s., 6.2 (infectious), PG II.\"\nTypically, material, including pharmaceutical waste, that does not contain a pathogen, or in\nwhich the pathogen has been inactivated or neutralized so that it cannot cause disease, does\nnot meet the definition of an infectious substances prescribed in§ 173.134(a)(1) and must not\nbe described or offered for transportation as a Division 6.2 material under the HMR (see\n§ 173.134(b)(l)-(b)(3)). However, the exception prescribed in§ 173.134(c)(2) permits waste\npharmaceutical materials to be offered for transportation and transported as RMW when\npackaged in a rigid non-bulk packaging conforming to the general packaging requirements of\n§§ 173.24 and 173.24a and packaging requirements specified in 29 CFR 1910.1030, and\ntransported by a private or contract carrier in a vehicle used exclusively to transport RMW\n(see Docket No. PHMSA-2009-0151 (HM-218F), July 20, 2011 (76 FR 43530)). Waste\n\n<<<PAGE 2>>>\n\npharmaceuticals that meet only one primary hazard class, are chemically compatible, and are\nplaced in one packaging in conformance with the requirements prescribed in§ 173.12(b) (lab\npack) may be described with generic proper shipping names instead of specific chemical ones,\nand are excepted from the specification packaging requirements for combination packagings\nwhen transported for disposal or recovery by motor vehicle, railcar, or cargo vessel. If the\npharmaceutical wastes you describe are not transported in conformance with one of these\nexceptions, they must be transported in conformance with the requirements prescribed in the\nHMR for each hazard class they meet. Please note that a person who otiers or accepts a\npackage that is not in conformance with the HMR is potentially subject to either a civil or\ncriminal penalty (see§§ 107.329 and 107.333).\nI hope this satisfies your request.\n. GlennFostt/4'\nChief, Regulatory Review and Reinvention Branch\nStandards and Rulemaking Division\n2\n\n<<<PAGE 3>>>\n\nEdmonson\nB t~3. 13L/\nDrakeford, Carolyn (PHMSA) S I] l · 2,;\nFrom:\nSent:\nTo:\nSubject:\nINFocNTR (PHMSA) Friday, April12, 2013 5:11 PM Drakeford, Carolyn (PHMSA) Re3ufa L-' Medtc{(,/ Llb.Je\nTC.U\n[r2.. () ~ 11\nFW: Proper Shipment of Non-RCRA Regulated Pharmaceutical Waste U- U\nHi Carolyn,\nThis caller requested we submit his e-mail as a formal letter of interpretation. The caller was previously referred to\nletter 02-0244\nThanks,\nVictoria\nFrom: Kieran Toale [mailto:Kieran.Toale@bellevue.nychhc.org]\nSent: Wednesday, March 20, 2013 11:33 AM\nTo: INFOCNTR (PHMSA); PHMSA Administrator (PHMSA); phmsa.chiefcounsel@dot.gov; PHMSA HM Hazmat Safety\nSubject: Proper Shipment of Non-RCRA Regulated Pharmaceutical Waste\nDear DOT,\nI would be grateful if you can please provide me with some guidance on the appropriate shipment of non RCRA regulated\npharmaceutical waste from the healthcare facility where I work in New York. Specifically I'd like to know if its acceptable\npractice to over classify such waste and ship it as regulated medical waste (RMW) on an RMW manifest using the\nfollowing shipping name?\nUN3291, Regulated Medical Waste, n.o.s., 6.2, PG II (Untreated)\nThis decision would be based on the rare possibility of a 5 gallon drum of non RCRA regulated pharmaceutical waste\ncontaining a single material or more that could actually be classified as RMW. To clarify the type of pharmaceutical waste\nthat I'm referring to would not meet any of the EPA definitions of being RCRA characteristic and it is not listed as being\nRCRA waste.\nI've reviewed the appropriate DOT regulations shown below and do not believe that over classifying non RCRA regulated\npharmaceutical waste for shipment is in compliance with DOT regulations. Would you be in agreement with my\ninterpretation?\nPer 49 CFR 171.2(e}\n\"No person may offer or accept a hazardous material for transportation in commerce unless the hazardous material\nis properly classed, described, packaged, marked, labeled, and in condition for shipment as required or authorized\nby applicable requirements of this subchapter or an exemption or special permit, approval, or registration issued\nunder this subchapter or subchapter A of this chapter.\"\nPer 49 CFR 171.2(i}\n\"No person may certify that a hazardous material is offered for transportation in commerce in accordance with the\nrequirements of this subchapter unless the hazardous material is properly classed, described, packaged, marked,\nlabeled, and in condition for shipment as required or authorized by applicable requirements of this subchapter or\n1\n\n<<<PAGE 4>>>\n\nan exemption or special permit, approval, or registration issued under this subchapter or subchapter A of this\nchapter.\"\nPer 49 CFR 172.204{a)\n\"This is to certify that the above-named materials are properly classified, described, packaged, marked and\nlabeled, and are in proper condition for transportation according to the applicable regulations the Department of\nTransportation.\"\nI look forward to receiving your response.\nMr. Kieran Toale\nIndustrial Hygienist, Haz Mat Coordinator\nBellevue Hospital Center, Safety Dept\n462 First Avenue, Room 742, Admin Bldg\nNew York1 NY 10016\nTel 212-562-37311 Cell 646-358-0638\nFax 212-562-7137\nkieran. toale@nychhc.org\nVisit www.nyc.gov/hhc\nCONFIDENTIALITY NOTICE: The information in this E-Mail may be confidential and may be legally\nprivileged. It is intended solely for the addressee(s).lfyou are not the intended recipient, any disclosure,\ncopying, distribution or any action taken or omitted to be taken in reliance on this e-mail, is prohibited\nand may be unlawful.lfyou have received this E-Mail message in error, notify the sender by reply E-\nMail and delete the message.\n2","truncated":false,"body_characters":7323}