{"operation":"document","citation":"05-0182","title":"Daniels Sharpsmart, Inc. — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2006-06-07","effective_on":null,"summary":"05-0182 response to Daniels Sharpsmart, Inc. concerning 173.134.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-05-0182.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-05-0182.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-05-0182","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2005/050182.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department\nof Transportation\nWash ngton, D.C. 20590\n400 Seventh Street, S.W.\nPipeline and\nAdministration\nHazardous Materials Safety\nJUN\n7 2006\nMr. Terry Grimmond\nDaniels Sharpsmart, Inc.\nClinical Director\nReference No. 05-0182\n3 Tarbett Road Hillcrest\nHamilton 2001, New Zealand\nDear Mr. Grimmond:\nQ1.\nMay packages complying with the Packing Group II performance criteria under the\nmported into the United States from other countries to be cleaned and refurbishe\nIMR and containing contaminated medical equipment, including sharps, br\nby Food and Drug Administration-approved companies? Are such devices\nregulated medical waste (RMW) regardless of whether or not they meet the\nmedical waste. Is this correct?\nAl.\nfor disposal, that is known or suspected of being contaminated with a Division 6.2\nIn accordance with § 173.134(b)(7), medical equipment, excluding that transported\nor teal anisit essentially sucianis a reuths mendelete the components\nprovided the equipment conforms to the Occupational Safety and Health\nAdministration's (OSHA's) bloodborne pathogen requirements prescribed in 29\nCFR 1910.1030. Medical equipment known or suspected of containing a Division\nbe transported in accordance with the HMR requirements applicable to the\n6.2 material that does not conform to the requirements in 29 CFR 1910.1030 must\ntransportation of RMW. Medical equipment that previously contained an\ninfectious substance that has been decontaminated is not subject to the HMR.\n173-1341631)\n050182\n\n<<<PAGE 2>>>\n\nQ2. If contaminated medical equipment is not subject to the HMR's Division 6.2.\ntransport, or labeling?\nrequirements, is it subject to any other requirements under the HMR for packaging,\nA2.\nMedical equipment transported in commerce that contains a material meeting the\nrequirements contained within the HMR for that hazard class.\ndefinition of any hazard class under the HMR is subject to the applicable\nQ3.\nMay any state within the United States impose transportation requirements for\nmedical equipment that are more stringent than those in the HMR?\nA3.\ntransportation law (Federal hazmat law; 49 U.S.C. 5101 et seq.), a requirement of a\nGenerally, the answer is no. In accordance with the Federal hazardous materials\nstate, local, or tribal government is preempted, unless otherwise author. zed by\nanother Federal statute or DOT issues a waiver of preemption, under the conditions\nspecified in § 171.1(f) of the HMR. Note, however, that PHMSA makes\npreemption determinations applicable to specific non-Federal requirements on a\ncase-by-case basis.\nQ4.\nIf blood-stained medical equipment is imported into the United States for cleaning\nand refurbishment and meets FDA and OSHA requirements, is it excepted from\ncomplying with the HMR for Division 6.2 materials?\nA4. See Al above.\nQ5. What other United States agencies regulate imported medical waste devices?\nA5.\nImported medical equipment may be subject to regulations issued by the U.S.\nPostal Service; the Department of Health and Human Services' Centers for Disease\nControl and Prevention, and Food and Drug Administration; the Department of\nabor's Occupational Safety and Health Administration; the U.S. Department of\nIomeland Security' Transportation Security Administration and U.S. Coast Guard\nor the U.S. Department of Agriculture's Animal Plant and Health Inspection\nService. You may wish to contact those agencies directly.\nQ6.\nMay a state enact regulations reclassifying non-infectious medical equipment as\nRMW making these items subject to the HMR?\nA6.\nNo. See A3 above.\nQ7.\nIs it correct that medical equipment transported for reprocessing is not subject to\nequipment is excepted from regulation under § 173.134(b)(7) of the HMR?\nthe requirements for used health care products in § 173.199 because medical\nA7.\nproducts being returned to the manufacturer or the manufacturer's designee.\nYes. Note that the requirements for used health care products in § 173.199 apply to\n\n<<<PAGE 3>>>\n\nIs it correct that medical equipment cleaned prior to shipment for refurbishment\nmay be transported both internationally and domestically as general goods not\nleakproofness, or BIOHAZARD labeling?\nsubject to OSHA requirements, including those for puncture resistance,\nA8.\nMedical equipment cleaned to the point that it no longer meets the definition of a\nnot cleaned medical equipment would be subject to OSHA requirements, you may\nHMR hazard class not subject to regulation under the HMR. To learn whether or\nwish to contact OSHA directly at: U.S. Department of Labor, Occupational Safety\nWashington, D.C. 20210, (202) 693-2222.\n& Health Administration, Safety Standards Division, 200 Constitution Avenue,\nI hope this information is helpful.\nSincerely,\nHallu z. mitcheli\nHattie L. Mitchell, Chief\nOffice of Hazardous Materials Standards\nRegulatory Review and Reinvention\n\n<<<PAGE 4>>>\n\nPage 1 of 2\nEdmonson, Eileen <PHMSA>\nEdmonson\nFrom:\nTerry Grimmond [TGrimmond@danielsinternational.com]\n§/73.134 (b)(1)\nSent:\nTuesday, August 02, 2005 7:14 AM\nTo:\nEdmonson, Eileen <PHMSA>\nRegulated Medical liose\nSubject: RE: Shipping RMW to USA\nExceptions\nHi Eileen,\n05-0182\nThanks for confirmation that RMW coming into US comes under DOT jurisdiction.\nMy specific Q is: Can containers (PG2 compliant) of non-decontaminated medical devices, which may include \"sharps\",\nbe received in US from other countries so as to be cleaned and refurbished by FDA-approved companies?\nThis is a rapidly growing industry in US.\nIn US, expensive, disposable Medical Equipment/Devices are sent back to mfg or third party for reprocessing and resale.\nirrespective of whether they were decontaminated before shipping. Can you advise DOT's regulations on this?\nSomewhere, I thought I saw such devices were NOT classed as RMW irrespective of whether they were sharp, and\nind not classified as RMW - do I read this. correctly\nara 173.134 (b) (7) refers to medical equipment being shipped for \"..cleaning or refurbishment\" as being an exceptio\nKind regards,\nTerry\nFrom: Edmonson, Eileen <RSPA> [mailto:eileen.edmonson@RSPA.dot.gov]\nTo: Terry Grimmond\nSent: Friday, 11 February 2005 9:39 AM\nCc: Gorsky, Susan <RSPA>\nSubject: RE: Shipping RMW between counties\nHi Terry,\ntransportation to the United States or one of its territories.\nThe answer is yes to both questions when RMW is being transported in commerce in, through, or intended for\nSee § 171.1(a) of 49 CFR Parts 171-180, and 49 U.S.C. 5101\nEileen Edmonson\nRegulatory Review and Reinvention, DHM-12\nTransportation Regulations Specialist\nOffice of Hazardous Materials Standards\nResearch and Special Programs Administration\n(main office) 202-366-8553\n(w-direct) 202-366-4481\n(fax) 202-366-3012\nFrom: Terry Grimmond [mailto:terry.grimmond@sharpsmart.com\n-----Original Message-----\nTo: Edmonson, Eileen <RSPA>\nSent: Monday, February 07, 2005 11:42 PM\nSubject: Shipping RMW between counties\n08/02/2005\n\n<<<PAGE 5>>>\n\nPage 2 of 2\nHi Eileen,\nDoes DOT have jurisdiction over:\nRMW shipped to USA from other countries - eg Canada, UK, Europe?\nKind regards,\nRMW generated in USA but shipped to other countries - eg Canada, UK, Europe?\nTerry\n08/02/2005","truncated":false,"body_characters":7136}