{"operation":"document","citation":"22-0070","title":"Scopelitis, Gavin, Light, Hanson & Feary, P.C. — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2023-08-22","effective_on":null,"summary":"22-0070 response to Scopelitis, Gavin, Light, Hanson & Feary, P.C. concerning 173.197.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-22-0070.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-22-0070.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-22-0070","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/docs/standards-rulemaking/hazmat/interpretations/77861/220070.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department\nof Transportation\nPipeline and Hazardous\nMaterials Safety\nAdministration\nAugust 22, 2023\n1200 New Jersey Avenue, SE\nWashington, DC 20590\nMr. Timothy W. Wiseman\nPartner\nScopelitis, Gavin, Light, Hanson & Feary, P.C.\n10 West Market Street, Suite 1400\nIndianapolis, IN 46204\nReference No. 22-0070\nDear Mr. Wiseman:\nThis is in response to your July 14, 2022, letter requesting clarification of the Hazardous\nMaterials Regulations (HMR; 49 CFR Parts 171-180) applicable to the transportation of used\nsharps. Specifically, you ask about a plastic film bag used as an inner packaging when\ntransporting sharps in a Large Packaging.\nWe have paraphrased and answered your questions as follows:\nQ1. In your letter, you note that § 173.197(e)(3) of the HMR specifies that sharps transported\nin a Large Packaging must be packaged in a puncture-resistant, non-bulk inner packaging\n(sharps container)—which in your opinion may be similar to the plastic film bag\nidentified in § 173.197(e)(1) used to transport solid regulated medical waste. You ask\nwhether the non-bulk inner packaging (sharps container) may be a plastic film bag\nprovided it is puncture-resistant, and—when exceeding 20 gallons—capable of passing\nthe performance test in Part 178, Subpart M at the Packing Group II performance level.\nA1. Paragraph (e)(1) of § 173.197 specifies the requirements for the inner packaging for solid\nregulated medical waste transported in a Large Packaging. Sharps are objects that can\npierce certain types of packaging, therefore, the inner packaging for sharps transported in\na Large Packaging must conform to § 173.197(e)(3). Each puncture-resistant, non-bulk\ninner packaging (sharps container) used to transport sharps in a Large Packaging must be\nsecurely closed to prevent leaks or punctures in conformance with instructions provided\nby the packaging manufacturer and each sharps container exceeding 76 L (20 gallons) in\nvolume must be capable of passing the performance tests in part 178, subpart M at the\nPacking Group II performance level. A sharps container intended for reuse in a Large\nPackaging must be approved and certified as a medical device for reuse by the U.S. Food\nand Drug Administration (FDA) and meet additional requirements under § 173.197(e)(3).\nPlease note, a sharps container may be subject to other requirements, such as The\nOccupational Safety and Health Administration (OSHA) Bloodborne Pathogens standard\n(see 29 CFR § 1910.1030) and FDA and U.S. Environmental Protection Agency (EPA)\nrequirements.\n\n<<<PAGE 2>>>\n\nQ2. You ask what specific performance test may be required under Part 178, Subpart M for\nthe plastic film bag used as the inner packaging of a Large Packaging when transporting\nsharps.\nA2. PHMSA has not identified a testing procedure to determine whether a poly bag can resist\npunctures from hypodermic needles and other sharp objects generated in the medical\nindustry. If you can identify a test standard that demonstrates puncture resistance of a\npoly bag to objects— such as used hypodermic needles— and provides for an appropriate\nlevel of safety for the transportation of hazardous materials, you may ask PHMSA to\nincorporate by reference a new standard by filing a petition for rulemaking in accordance\nwith rulemaking procedures in §§ 106.95-106.105.\nI hope this information is helpful. Please contact us if we can be of further assistance.\nSincerely,\nT. Glenn Foster\nChief, Regulatory Review and Reinvention Branch\nStandards and Rulemaking Division\n\n<<<PAGE 3>>>\n\nPollack\n22-0070\nFrom: Foster, Glenn (PHMSA)\nTo: Date: Attachments: Dodd, Alice (PHMSA); Hillman, Kenetha CTR (PHMSA)\nSubject: FW: Request for Guidance\nThursday, July 14, 2022 6:17:16 AM\nFoster - Request Interpretation 7-13-22.docx\nGood morning, Alice and Kenetha.\nPlease have the attached checked in and assigned as a request for a letter of interpretation.\nThanks,\nGlenn\nFrom: Wiseman, Tim <twiseman@scopelitis.com>\nSent: Thursday, July 14, 2022 5:46 AM\nTo: PHMSA_Guidance <PHMSA_Guidance@dot.gov>\nCc: Foster, Glenn (PHMSA) <Glenn.Foster@dot.gov>\nSubject: Request for Guidance\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.\nPlease find the attached Request for Guidance, and let me know if you have any\nquestions. Thanks! -Tim\nTimothy W. Wiseman, Partner\nScopelitis, Garvin, Light, Hanson & Feary, P.C.\n10 West Market Street, Suite 1400, Indianapolis, IN 46204\ntwiseman@scopelitis.com | T: 317.637.1777 | D: 317.492.9221\nCONFIDENTIALITY NOTICE: This message is privileged and confidential for the addressee(s) named above. If you are not the intended\nrecipient, you are prohibited from disseminating, using, or copying the contents and should notify the sender immediately that you\nreceived this message in error. The signature(s) within this email does not constitute any binding agreement.\n\n<<<PAGE 4>>>\n\n10 West Market Street\nSuite 1400\nIndianapolis, IN 46204 TIMOTHY W. WISEMAN\ntwiseman@scopelitis.com\nThe full service transportation law firm\nwww.scopelitis.com\nMain (317) 637-1777\nFax (317) 687-2414\nAugust 23, 2023\nMr. T. Glenn Foster, Chief\nRegulatory Review & Reinvention Branch\nStandards & Rulemaking Division\nU.S. Department of Transportation\nPipeline & Hazardous Material Safety Adm.\n1200 New Jersey Avenue, SE\nWashington, DC 20590\nRe: 49 C.F.R. § 173.197(e)(3)\nRequest for Interpretation\nDear Mr. Foster:\nPursuant to 49 C.F.R. § 105.20, I write to request guidance with respect to the\nrequirements for the transportation of sharps in a large packaging under 49 C.F.R. §\n173.197(e)(3), which provides, in pertinent part, as follows:\nSharps transported in a Large Packaging, Cart, or BOP must be\npackaged in a puncture-resistant inner packaging (sharps container).\nEach sharps container must be securely closed to prevent leaks or\npunctures in conformance with instructions provided by the packing\nmanufacturer. Each sharps container exceeding 76 L (20 gallons) in\nvolume must be capable of passing the performance test in Part 178,\nSubpart M, of this Subchapter at the Packing Group II performance level.\nIndianapolis ■ Chicago ■ Washington, D.C. ■ Los Angeles ■ Chattanooga\nDetroit ■ Dallas/Fort Worth ■ Milwaukee ■ Seattle ■ St. Louis ■ Cincinnati\nSERVICES OUTSIDE CALIFORNIA AND MICHIGAN PROVIDED BY SCOPELITIS, GARVIN, LIGHT, HANSON & FEARY, PROFESSIONAL CORPORATION\nSERVICES IN MICHIGAN PROVIDED BY SCOPELITIS, GARVIN, LIGHT, HANSON & FEARY, PROFESSIONAL LIMITED LIABILITY COMPANY\nSERVICES IN CALIFORNIA PROVIDED BY SCOPELITIS, GARVIN, LIGHT, HANSON & FEARY, LIMITED LIABILITY PARTNERSHIP\n\n<<<PAGE 5>>>\n\nMr. T. Glenn Foster, Chief\nAugust 23, 2023\nPage 2\nMy questions pertaining to the particular regulation are as follows:\n1. Can the inner packaging referenced in § 173.197(e)(3) be a plastic film\nbag (similar to the film bag identified in § 173.197(e)(1)) as long as it is\npuncture-resistant, and, when exceeding 20 gallons, capable of passing\nthe performance test in Part 178, Subpart M at the Packing Group II\nperformance level?\n2. If the response to Question #1 is yes, what specific performance test\nwould be required under Part 178, Subpart M, for the plastic film bag\nused as the inner packaging with a large packing for the transportation\nof sharps?\nIf any additional information is needed to consider this request, please do not hesitate\nto contact me.\nVery truly yours,\n/s/ Timothy W. Wiseman\nTimothy W. Wiseman\nTWW/kkc","truncated":false,"body_characters":7521}