{"operation":"document","citation":"17-0041","title":"WNWN International — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2018-01-11","effective_on":null,"summary":"17-0041 response to WNWN International concerning 171.8, 173.134, 173.197.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-17-0041.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-17-0041.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-17-0041","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/docs/standards-rulemaking/hazmat/interpretations/56971/170041.pdf","body":"<<>>\n\nEd Krisiunas\nPresident\nWNWN International\nP.O. Box 1164\nBurlington, CT 06013\nReference No. 17-0041\nDear Mr. Krisiunas:\nThis letter is in response to your April 25, 2017, emails requesting clarification of the Hazardous\nMaterials Regulations (HMR; 49 CFR Parts 171-180) applicable to the transportation of\nregulated medical waste, specifically sharps containers and transport of those containers by a\nprivate carrier.\nWe have paraphrased and answered your questions as follows:\nQ1.\nYou ask for confirmation of your understanding that the maximum size for a sharps\ncontainer that meets part 178, subpart M packaging performance standards at the packing\ngroup (PG) II performance level is 40 gallons.\nAl.\nPackaging size limits for sharps containers are linked to use. The 40-gallon limit you\nreference is associated with sharps containers intended to be reused as inner packagings\nof a Large packaging, a wheeled cart (Cart), or bulk outer packaging (BOP). See §\n173.197(e)(3). If the sharps container is not intended to be reused, then the size limit is\nnon-bulk. See § 173.197(e)(3)(d)(1)(i); see also § 171.8 for the definition of non-bulk.\nQ2.\nWith respect to Q1, you ask for confirmation that a sharps container can be transported as\na stand-alone container.\nA2.\nBased on our understanding that your intended meaning of \"stand-alone container\" is the\ncontainer does not have to be placed in an outer packaging, then your understanding is\ncorrect. Section 173.197(b) authorizes use of non-bulk packagings for transportation of\nsharps. These packagings are not required to be placed in an outer packaging.\n\n<<>>\n\n§ 173.197(b) for a full description of performance requirements for the non-bulk\npackaging.\nQ4.\nFinally, you explain that a private carrier, knowing the exceptions of § 173.134(c) for\nregulated medical waste, has a sharps container at the PG II performance level that is\npuncture resistant, and is filled with sharps, secured, but not placed in another container\nand then loaded in a motor vehicle. You ask if this is acceptable in accordance with\n§§ 173.134 and 173.197.\nA4. The answer is yes if all applicable requirements of § 173.197 are met.\nI hope this information is helpful. Please contact us if we can be of further assistance.\nSincerely,\nDirk Der Kinderen\nChief, Standards Development Branch\nStandards and Rulemaking Division\n\n<<>>\n\nat ta cata ca a can pa face is a request tor a letter or claritication.\nCan you please enter it in filemaker and assign it the next specialist in que?\nThanks,\nEileen Edmonson\nUSDOT/PHMSA\n(202) 366-4481 (work)\n(202) 366-8553 (main)\n(202) 366-7041 (fax)\n1-800-467-4922 (HazMat Info Center)\neileen.edmonson@dot.gov (e-mail)\ninfocntr@dot.gov (HMIC e-mail)\nFrom: ekrisiunas@gmail.com [mailto:ekrisiunas@gmail.com]\nSent: Tuesday, April 25, 2017 5:29 PM\nTo: Edmonson, Eileen (PHMSA) \nCc: Foster, Glenn (PHMSA) < Glenn.Foster@dot.gov>\nSubject: RE: Sharps container...capacity\nHello Eileen..\nPlease do submit...\nI have an additional question.\nI have a PGIl tested sharps container. 18 gallons...can this be the primary container for transport?\nA private carrier has decided that even though they have an exception per 173.134, they have a container that\nhas met the PG Il testing requirements and is puncture resistant. They are loading into a van.it is filled with\nsharps..securing it.. and driving to the next destination... it is not placed in any other container.\nIs this acceptable per DOT 173.134 and 173.197..\nRegards\nEd Krisiunas\n1\n\n<<>>\n\nI apologize for the delay in getting back to you. Under our new administration we are restricted on what and\nhow we can answer inquiries. We can answer those we've answered before, e.g., in rulemakings and letters\nof clarification. For those we haven't answered before, we must submit them for development as new request\nfor letter of clarification. Your question seems to be about how large a sharps packagings can be when placed\nin a Large, Wheeled Cart, or Bulk Outer Packaging under § 173.197(e)(3). If I've misunderstood your\nquestion, let me know.\nI found this language on page 32250 of the final rule that added this provision. Here is the link to the\nrule: https://www.gpo.gov/fdsys/pkg/FR-2006-06-02/pdf/06-4992.pdf.\n32244 Federal Register / Vol. 71, No. 106 / Friday, June 2, 2006 / Rules and Regulations\nDEPARTMENT OF TRANSPORTATION\nPipeline and Hazardous Materials\nSafety Administration\n49 CFR Parts 171, 172, 173, and 175\n[Docket No. PHMSA-2004-16895 (HM-\n226A)]\nRIN 2137-AD93\nHazardous Materials: Infectious\n\n<<>>\n\n(DOT).\nACTION: Final rule.\nA sharps container placed inside a bulk packaging, such as a UN specification Large Packaging or a non-\nspecification bulk outer packaging or wheeled cart, must be puncture resistant. A sharps container that is 20\ngallons or less in volume need not be a UN specification packaging if it is to be placed in a bulk outer\npackaging. A Sharps container that is larger than 20 gallons in volume that is placed inside a bulk packaging\nmust be capable of passing the performance tests in subpart M of part 178 at the Packing Group I|\nperformance level. A sharps container that will be placed in a bulk outer packaging for transportation may be\nreused only if it is specifically cleared or approved by FDA as a medical device for reuse and must have a\ncapacity of between 2 and 40 gallons.\nTherefore, the 40-gallon limit applies to reusable sharps containers placed in bulk packagings. To get further\nclarification on how large a \"non-reuseable\" sharps container can be under § 173.197(e)(3), I must submit your\nletter for processing as a new request for a letter of clarification\nDo I have your permission to do this?\nSincerely,\nEileen Edmonson\nUSDOT/PHMSA\n3\n\n<<>>\n\ninfocntr@dot.gov (HMIC e-mail)\nFrom: Edward Krisiunas [mailto: ekrisiunas@gmail.com]\nSent: Tuesday, April 25, 2017 12:40 PM\nTo: Edmonson, Eileen (PHMSA) < eileen.edmonson@dot.gov>\nSubject: Sharps container...capacity\nHello Eileen..\nWhat is the maximum size for a sharps container? Meets PG II requirements. tested per 178 Part M?\nI believe it is 40 gallons?\nAdditionally, this type of container can be transported as a stand alone container - Correct?\nRegards,\nEd\n4\n\n<<>>\n\n06013\n1-860-675-1217 (O)\n1-860-675-1311 (F)\n1-860-839-3993 (M)\nSKYPE - Boutiquewaste\nPRIVACY NOTICE: This information is intended only for the use of the individual or entity to which it is\naddressed and may contain information that is privileged, confidential or exempt from disclosure under\napplicable federal or state law. If the reader of this message is not the intended recipient or the employee or\nagent responsible for delivering the message to the intended recipient, you are hereby notified that any\ndissemination, distribution or copying of this communication is strictly prohibited. If you have received this\ncommunication in error, contact the sender and delete the material from any computer.","truncated":false,"body_characters":6975}