{"operation":"document","citation":"09-0043","title":"Otto Environmental Systems — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2009-08-24","effective_on":null,"summary":"09-0043 response to Otto Environmental Systems concerning 173.134, 173.197, 173.22.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-09-0043.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-09-0043.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-09-0043","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretations/2009/090043.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department\nof Transportation\nPipeline and Hazardous Materials\nSafety Administration\nAUG 2 4 2009\n1200 New Jersey Ave.. SE\nWashington, DC 20590\nMr. Rob Ellis\nDirector of Market Development\nOtto Environmental Systems\n12700 General Drive\nCharlotte, NC 28273\nReference No. 09-0043\nDear Mr. Ellis:\nThis is in response to your February 22, 2009 letter requesting clarification of the packaging\nrequirements for \"UN 3291, Regulated medical waste, n.o.s., 6.2 (infectious), PG 11\" under\nthe Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180). We have paraphrased\nyour questions and answered them in order. We apologize for the delay in responding and\nany inconvenience this may have caused.\nQ1. Based on the regulatory language in $ 173.134, are packaging requirements applicable to\nregulated medical waste (RMW) limited to those prescribed in $ 173.197 that were revised\non October 1, 2007?\nAl. No. Regulated medical waste that contains a Category A infections substance must be\ndescribed as \"UN2814, Infectious substances, affecting humans, 6.2\" or \"UN2900, Infectious\nsubstances, affecting animals, 6.2\", as appropriate, and packaged in accordance with the\nrequirements in $173.196. Regulated medical waste that contains a Category B infectious\nsubstance may be placed in packagings that meet the requirements in $ 173.6 (materials of\ntrade), 173.134 (exceptions), or 173.197 (regulated medical waste), as applicable. Section\n173.6(a)(4)(ii) requires RMW to be placed in a combination packaging; $ 173.196(a) requires\nRMW to be placed in a triple packaging; and $0 173.134(~)(1) and (c)(2), and 173.197\nrequire RMW to be placed in a single or combination packaging depending on the\npackaging's design type and performance.\nQ2. May RMW be transported in a bulk outer packaging (BOP) such as a plastic 32 g, 65 g,\n95 g, 660 L or 770 L cart with an appropriate inner container such as a standard \"red bag\"\nand with an appropriate exterior label on the plastic cart (examples attached).\nA2. Yes. Under the HMR, regulated medical waste may be transported in a BOP provided\nthe packaging conforms to the requirements in $ 173.197(a), (d), and (e).\n\n<<<PAGE 2>>>\n\nQ3. May chemotherapeutic waste be transported in a BOP such as a plastic 32 g, 65 g, 95 g,\n660 L or 770 L cart with an appropriate inner container such as an approved\nchemotherapeutic yellow container and appropriate labeling (examples attached).\nA3. The hazard class assigned to chemotherapeutic waste is based on its chemical\ncomposition, concentration of ingredients, and hazard characteristics. Under fj 173.22, the\nshipper is responsible for determining if a material meets the definition of a hazard class, and\nfor assigning the material an appropriate proper shipping name and selecting the appropriate\npackaging, markings, and labels. Division 6.2 chemotherapeutic waste may be placed in a\nBOP that conforms to the packaging requirements prescribed in 8 173.197 (c), (d), and (e).\nSection 173.134(d) requires a Division 6.2 material listed in the exceptions under fj\n173.134(b) and (c) that also meets the definition of another hazard class, or that is a\nhazardous substance, hazardous waste, or marine pollutal~t to comply with the applicable\nrequirements of the HMR for each hazard class it contains, which includes, if applicable,\nplacing the Division 6.1 label on the outside of the package. Please note that\nchemotherapeutic waste that meets more than one hazard class must be classed in accordance\nwith the provisions contained in fj 173.2a, and, as stated earlier, must conform to the\napplicable requirements for each hazard class. Also, 8 173.2a(c)(3) requires a Division 6.2\nmaterial that also meets the definition of another hazard class, which may include a limited\nquantity Class 7 material but no other type of Class 7 material, to be classed as Division 6.2.\n44. May sharps be transported in a BOP such as a plastic 32 g, 65 g, 95 g, 660 L or 770 L\ncart with an appropriate inner container such as an approved sharps container and appropriate\nlabeling (examples attached).\nA4. Yes. Under the HMR, sharps that are regulated medical waste may be transported in a\nBOP provided the packaging complies with 5 173.197(a), (d), (e) introductory paragraph, and\n(e)(3).\nI hope this satisfies your request.\nHattie L. Mitchell\nChief, Regulatory Review and Reinvention\nOffice of Hazardous Materials Standards\n\n<<<PAGE 3>>>\n\nOTTO Environmental Systems\nRob Ellis\n12700 General Drive\nCharlotte, North Carolina 28273\nTelephone: 704.497.5365\nFacsimile: 41 3.21 5.5306\nrellisbotto-usa.com\nwww.otto-usa.com\nwww.ottocontainermanaqement.com\nphmsa.hm-infocenter@dot.crov; infocntr@dot.aov\nU.S. Department of Transportation\n1 200 New Jersey Ave, SE\nWashington, DC 20590\nReference: Questions regarding clarification on \"Regulated Medical Waste Packaging\" regulations\nrequirements:\nTo PHMSA Information Center:\nThank you for the opportunity to utilize your professional expertise regarding CFR49 and regulated\nmedical waste. Numerous hours have been spent researching this document and hence a few\nquestions have developed. With this stated, I would like to ask you (4) questions to clarify my\ninterpretation of these regulations and to either receive confirmation from you that my understanding\nis correct or guidance from you as to appropriate interpretation of the regulation if I am incorrect.\nUnderstanding, based on review and interpretation of the U.S. Depart of Transportation's Regulations\non Medical Waste found in the CFR49 document can it be interpreted that Regulated Medical\nWaste does not fall under the packaging requirements for infectious substances CFR49 173.1 96 for\nthe reason of an exception found in CFR49 173.1 34 sec (c), \"Exceptions for Medical Waste ...\"\nQUESTION (7): Based on this section of CFR 1 73.1 34, does this mean that the pertinent\nregulations for packaging \"Regulated Medical Waste\" are limited to CFR49 173.1 97, revision\nOctober ls+, 2007 which have been highlighted below.\nI CFR49 1 73.1 34 sec fcl. \"Exce~tions for Medical Waste. ..I1 1\n[Code of Federal Regulations]\n[Title 49, Volume 21\n[Revised as of October 1,20061\nFrom the U.S. Government Printing Office via GPO Access\n[CITE: 49CFR 1 73.1 341\n[Page 520-5241\nTITLE 49--TRANSPORTATION\nCHAPTER I--PIPELII\\IE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION,\nDEPARTMENT OF TRANSPORTATION\n\n<<<PAGE 4>>>\n\nPART 173-SHIPPERS-GENERAL REQUIREMENTS FOR SHIPMENTS AND PACKAGINGS-\nSubpart D-Definitions Classification, Packing Group Assignments and\nExceptions for Hazardous Materials Other 'Than Class 1 and Class 7\nSec. 173.1 34 Class 6, Division 6.2--Definitions and exceptions.\n. . .\n(c) Exceptions for regulated medical waste. The following\napply to the transporta.l.ion of regulated medical waste:\n( 1 ) A regulated medical waste transported by a private or\ncarrier is excepted from--\n[i) 'The requirement for an \"INFECTIOUS SUBSTANCE\" label if the outer packaging is marked with a \"BIOHAZARD\" marking in acco\nwith 29 CFR 19 10.1030: and\n(ii] The specific packaging requirements of Sec. 173.1 97, if\npackaged in a rigid non-bulk packaging conforming to the gener\npackaging requirements of Sec. Sec. 173.24 and 173.24~ and pa\nrequirements specified in 29 CFR 191 0.1 030, provided the\nnot include a waste concentrated stock culture of an infectious\nsubstance.\nEEE%@ilmb\nSharps containers must be securely closed to prevent leaks or pdctures.\nQUESTION 12): If the answer to the first question is yes, then based on these sections of CFR49\n173.1 97, does this mean that \"Regulated Medical Waste\" can be transported in a (BOP)\nsuch as a plastic 32g, 65g, 95g, 660L or 770L cart with an appropriate inner container such as\na standard \"Red-Bag\" and with appropriate exterior labeling on the plastic cart. Example of\nthe 32g, 65g, 95g, 660L and 770L carts are illustrated at the bottom of this email and\nattached .pdf7s.\nQUESTION (3): If the answer to the first question is yes, then based on these sections of CFR49\n173.197, does this mean that \"Chemotherapeutic Waste\" can be transported in a (BOP)\nsuch as a plastic 32g, 65g, 95g, 660L or 770L cart with an appropriate inner container such as\nan approved chemotherapeutic yellow container and appropriate labeling. Example of the\n32g, 65g, 95g, 660L and 770L carts are illustrated at the bottom of this email and attached\n.pdfls.\nQUESTION (4): If the answer to the first question is yes, then based on these sections of CFR49\n173.197, does this mean that \"Sharps\" can be transported in a (BOP) such as a plastic 32g,\n65g, 95g, 660L or 770L cart with an appropriate inner container such as an approved sharps\ncontainer and appropriate labeling. Exarr~ple of the 32g, 65g, 95g, 660L and 770L carts are\nillustrated at the bottom of this email and attached .pdf7s.\n1 CFR49 173.1 97. Reaulated Medical Waste 1\n[Code of Federal Regulations]\n[Title 49, Volume 21\n\n<<<PAGE 5>>>\n\n[Revised as of October 1,20071\nFrom the U.S. Government Printing Office via GPO Access\nICITE: 49CFR 173.1971\nCHAPTER I--PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION,\nDEPARTMENT OF TRANSPORTATION\nPART 173-SHIPPERS-GENERAL REQUIREMENTS FOR SHIPMENTS AND PACKAGINGS--\nTable of Contents\nSubpart E-Non-bulk Packaging for Hazardous Materials Other Than Class 1\nand Class 7\nSec. 173.197 Regulated medical waste.\n. . .\n(d) Non-specification bulk packaging. A wheeled cart (Cart) or bulk\nouter packaging (BOP) is authorized as an outer packaging for the\ntransportation of regulated medical waste in accordance with the\nprovisions of this paragraph (d).\n(1 ) General requirements. The following requirements apply to the\ntransportation of regulated medical waste in Carts or BOPS:\n(i) Regulated medical waste in each Cart or BOP must be contained in\nnon-bulk inner packagings conforming to paragraph (e) of this section.\n(ii) Each Cart or BOP must have smooth, non-porous interior surfaces free of cracks, crevices, and other defects that could damage plastic\nfilm inner packagings or impede disinfection operations. (iii) Except as otherwise provided in this paragraph (d), each Cart\nor BOP must be used exclusively for the transportation of regulated\nmedical waste. Prior to reuse, each Cart or BOP must be disinfected by\nany means effective for neutralizing the infectious substance the\npackaging previously contained.\n(iv) Untreated concentrated stock cultures of infectious substances\ncontaining Category A materials may not be transported in a Cart or BOP.\n(v) Division 6.1 toxic waste or Class 7 radioactive waste, with the\nexception of chemotherapeutic waste, may not be transported in a Cart 05\nBOP.\n(vi) Division 6.1 or Class 7 chemotherapeutic waste; untreated\nconcentrated stock cultures of infectious substances containing Category\nB infectious substances; unabsorbed liquids; and sharps containers may\nbe transported in a Cart or BOP only if packaged in rigid non-bulk\npackagings conforming to paragraph (a) of this section.\n(2) Wheeled cart (Cart). A Cart is authorized as an outer packaging\nfor the transportation of regulated medical waste if it conforms to the\nfollowing requirements:\n(i) Each Cart must consist of a solid, one-piece body with a nominal\nvolume not exceeding 1,655 L (437 gallons).\n(ii) Each Cart must be constructed of metal, rigid plastic, or\n&gY!&d\nWdU@\nWa&\n\n<<<PAGE 6>>>\n\nfiberglass fitted with a lid to prevent leakage during transport.\n(iii) Each Cart must be capable of meeting the requirements of Sec.\n178.810 (drop test) at the Packing Group II performance level.\n(iv) Inner packagings must be placed into a Cart and restrained in\nsuch a manner as to minimize the risk of breakage.\n...\n(3) Sharps. Sharps transported in a Large Packaging, Cart, or BOP\nmust be packaged in a puncture-resistant inner packaging (sharps\ncontainer). Each sharps container must be securely closed to prevent\nleaks or punctures in conformance with instructions provided by the\npackaging manufacturer. Each sharps container exceeding 76 L (20\ngallons] in volume must be capable of passing the performance tests in\nPart 178, subpart M, of this subchapter at the Packing Group II\nperformance level. A sharps container may be reused orlly if it conforms\nto the following criteria:\n(i) The sharps container is specifically approved and certified by\nthe U.S. Food and Drug Administration as a medical device for reuse.\n(ii) The sharps container must be permanently marked for reuse.\n(iii) The sharps container must be disinfected prior to reuse by any\nmeans effective for the infectious substance the container previously\ncontained.\nI I\nThank you for your assistance, clarification and answers to these ques,lions,","truncated":false,"body_characters":12610}