{"operation":"document","citation":"24-0049","title":"Clean Harbors — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2024-12-18","effective_on":null,"summary":"24-0049 response to Clean Harbors concerning 173.134, 173.197.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-24-0049.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-24-0049.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-24-0049","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/2025-01/240049.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department\nof Transportation\nPipeline and Hazardous\nMaterials Safety\nAdministration\n1200 New Jersey Avenue, SE\nWashington, DC 20590\nDecember 18, 2024\nMr. Paul Rheaume\nClean Harbors\n2130 E. Grauwyler Road\nIrving, TX 75061\nMr. Kent Bongarzone\nCyn Environmental Services\n100 Tosca Drive\nStoughton, MA 02072\nReference No. 24-0049\nDear Messrs. Rheaume and Bongarzone:\nThis letter is in response to your June 3, 2024, and June 11, 2024, letters requesting clarification\nof the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to regulated\nmedical waste (RMW).\nWe have paraphrased and answered your questions as follows:\nQ1. In your June 11, 2024, letter you describe a scenario where urine cups are re-capped after\nlaboratory testing is completed. The urine cups—containing liquid contents—are further\nplaced in red bags with a single knot and then placed in 31-gallon RMW containers with\nfolding clamshell lids. You ask whether the above-described packaging is in compliance\nwith § 173.134(b)(12)(ii).\nA1. The answer is no, as the provisions in § 173.134(b)(12)(ii) apply to “used health care\nproducts”1 being returned to the manufacturer or the manufacturer’s designee. Patient\nspecimens being transported for disposal do not meet this criterion.\nQ2. In your June 3, 2024, letter you describe a scenario where liquid bodily fluid contained in\nscrew-top leak-resistant containers is classed as “UN3291, Medical waste, n.o.s., 6.2.”\nThe containers are packaged in UN4H2 plastic boxes in accordance with § 173.197(b).\nYou further state that the cups are braced or cushioned to prevent shifting or damage.\nYou ask whether the above packaging scenario is authorized under § 173.197(b).\n1 https://www.ecfr.gov/current/title-49/part-173/section-173.134#p-173.134(a)(8)\n\n<<<PAGE 2>>>\n\nA2. The answer is yes. Provided—as you describe in your letter—there are no sharps or\nforeign articles present, materials properly classed under “UN3291, Medical waste, n.o.s.,\n6.2” may be transported in UN standard packagings conforming to the requirements of\npart 178 of the HMR.\nI hope this information is helpful. Please contact us if we can be of further assistance.\nSincerely,\nAlexander Wolcott\nActing Chief, Regulatory Review and Reinvention Branch\nStandards and Rulemaking Division\n\n<<<PAGE 3>>>\n\nPollack\n24-0049\nFrom: INFOCNTR (PHMSA)\nTo: Dodd, Alice (PHMSA)\nCc: Hazmat Interps\nSubject: FW: Regulations pertaining to liquid in Regulated Medical Waste Request for Answer and Interpretation\nDate: Friday, June 14, 2024 4:44:58 PM\nAttachments: Clarification Letter Liquid in RMW - Signed.pdf\nHello Alice,\nPlease see the attached interpretation request.\nLet me know if you need anything.\n-Breanna\nFrom: Rheaume, Paul <rheaume.paul@cleanharbors.com>\nSent: Tuesday, June 11, 2024 6:54 PM\nTo: INFOCNTR (PHMSA) <INFOCNTR.INFOCNTR@dot.gov>\nSubject: Regulations pertaining to liquid in Regulated Medical Waste Request for Answer and\nInterpretation\nCAUTION: This email originated from outside of the Department of Transportation (DOT). Do\nnot click on links or open attachments unless you recognize the sender and know the content\nis safe.\nGood evening,\nPlease see the attached request for regulatory guidance and interpretation.\nThank you for your assistance,\nPaul\nSafety Starts With Me: Live It 3-6-5\n____________________________________________________________________________\n___\nPaul Rheaume\nCLH Account Manager, Healthcare Services\nClean Harbors\nSouth Region\n(C) 254-405-9530\nRheaume.Paul@CleanHarbors.com\nwww.cleanharbors.com\nUpcoming PTO: from 7/4/2024 returning 7/16/2024\n\n<<<PAGE 4>>>\n\n\n\n<<<PAGE 5>>>\n\nPaul Rheaume\nClean Harbors\n2130 E. Grauwyler Road\nIrving, TX 75061\n254-405-9530\nJune 11, 2024\nU.S. Department of Transportation\nPipeline and Hazardous Materials Safety Administration\n1200 New Jersey Avenue, SE\nWashington, DC 20590\nVia: Certified U.S. Mail and Email\nRe: Question Regarding Liquid Regulated Medical Waste Packaging Requirements Follow-up\nIn a follow up to my previous email and Kent Bongarzone’s letter dated June 3, 2024, included.\nI would like to get the PHMSA’s guidance on the current practice of one of our accounts and an\ninterpretation of 49 CFR 173.134(b)(12)(ii)(A).\nFirst, the current practice is to recap urine cups after testing and disposing of them into a red\nbagged lined 31 gallon regulated medical waste tub, with folding clamshell lids. Assuming the\nred bag is single knot tied or closed using a zip tie, is this practice compliant with applicable\npackaging standards and exemptions for medical waste transported on a dedicated hazardous\nmaterial truck?\nSecondly, is the below regulation applicable to the urine cups mentioned in the previous\nquestion?\n49 CFR 173.134(b)(12)(ii)(A)\n(A) Each used health care product must be drained of free liquid to the extent practicable and placed\nin a watertight primary container designed and constructed to assure that it remains intact under\nconditions normally incident to transportation. For a used health care product capable of cutting\nor penetrating skin or packaging material, the primary container must be capable of retaining the\nproduct without puncture of the packaging under normal conditions of transport. Each primary\ncontainer must be marked with a BIOHAZARD marking conforming to 29 CFR\n1910.1030(g)(1)(i).\nThank you for your time and assistance in providing a written answer and interpretation.\nSincerely,\nPaul Rheaume\nCLH Account Manager, Healthcare\nClean Harbors Environmental Services\n“People and Technology Creating a Safer, Cleaner Environment”\n\n<<<PAGE 6>>>\n\nCleanHarbors®\nJune 3, 2024\nFROM:\nKent Bongarzone\nCyn Environmental Services\n100 Tosca Drive\nStoughton, MA 02072\nTO:\nUS Department of Transportation\nPipeline and Hazardous Materials Safety Administration\n1200 NEW JERSEY AVENUE, SE\nWASHINGTON, DC 20590\nVia: Certified US Mail\nRe: Question Regarding Liquid Regulated Medical Waste Packaging Requirements.\nI hope this message finds you well.\nI would like to request clarification as to if I have a proper understanding of the packaging\nregulations applicable to Regulated Medical Waste (RMW) under 49CFR $173.197 Regulated\nmedical waste. Paragraphs A, B & C are for reference.\n(A) Waste: A medical facility regularly generates containers of Regulated Medical Waste. The\nRMW consists of liquid bodily fluid placed into leak resistant non-rated plastic containers,\nsmaller than 10 ounce capacity, closed with screw top lids, commonly referred to as\nClosed Cups. The are no sharps or foreign articles present. The proper USDOT shipping\nname has been determined by the shipper to be UN3291, MEDICAL WASTE, N.O.S., 6.2, PG\nII.\n(B) Packaging: A UN Rated plastic closed bin meeting the UN rating of\nUN4H2/430/S/23/USA/+AA6065 manufactured by Rehrig Medical Systems. Attached\nplease find the UN/DOT Performance Testing Results for this container. This package UN\nrating specifies this container is as follows:\na.\n4= Box,\nb. H= Plastic,\nc. 2 = Removable top.\nd. Y = PG||.\ne. 30.7 = Gross mass rating in kg.\nf.\nS = Intended to contain solids only or inner packagings.\ng. 23 = year of manufacturer.\nh. USA = state of manufacture.\ni. Symbol of the manufacturer.\n\n<<<PAGE 7>>>\n\nENVIRONMENTAl\nCleanHarbors\n(C) Regulation: §173.197 details the packaging requirements for RMW. For the material above,\nthe regulations require the packaging must be rigid containers meeting the provisions of\nsubpart B of part 173 (21-67), and be UN standard packagings conforming to the\nrequirements of part 178 of this subchapter at the Packing Group II performance level.\nQuestion: Since the closed cups of RMW are inner packagings, would you agree that if all of the\nprovisions of subpart B of part 173 (21-67) are met, including the inner packagings being braced or\ncushioned to prevent shifting or damage, that it would be acceptable to place the waste in (A)\nabove into package (B) under regulation (C)?\nPlease do not hesitate to contact me if you have any questions, concerns, or need more\ninformation provided.\nThank you for your time and assistance, it is very much appreciated.\nRespectfully,\nKent Baggare\nKent Bongarzone\nTransportation Compliance Specialist\nCyn Environmental Services / Clean Harbors Inc.\nBongarzone.kenton@cleanharbors.com\n781-664-8310 (cell)\nAttachment: Ten-E Test Report# 19-MN20298 / UN/DOT Performance Testing Results","truncated":false,"body_characters":8339}