{"operation":"document","citation":"06-0098","title":"PTP Consulting, Inc. — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2006-05-11","effective_on":null,"summary":"06-0098 response to PTP Consulting, Inc. concerning 173.134.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-06-0098.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-06-0098.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-06-0098","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2006/060098.pdf","body":"<<<PAGE 1>>>\n\n.S. Departmer\nf Transportatio\n400 Seventh Street, S.W.\nWashington, D.C. 20590\nPipeline and\nHazardous Materials Safety\nAdministration\nMAY 11 2006\nPresident\nMs. Carol Brozosky, CET, CHMM\nRef. No. 06-0098\nPTP Consulting, Inc.\n1531 Kings Highway\nSwedesboro, NJ 08085\nDear Ms. Brozosky:\nThis responds to your April 22, 2006 letter concerning the applicability of the Hazardous\nMaterials Regulations (HMR; 49 CFR Parts 171-180) to used health care products.\nSpecifically, you ask whether the HMR apply to used contact lenses returned to the\nmanufacturer by consumers or healthcare professionals.\nFor purposes of the HMR, a used health care product is a medical, diagnostic, or research\ninfectious body fluids or materials (see § 173.134(a)(9)). It is the opinion of this Office\ndevice or piece of equipment or a personal care product contaminated with potentially\nnot although a us cd contact lens mets the definion fra used alth workers oct it is\nor healthcare professionals is not subject to regulation under the HMR.\ngeneral public. Thus, transportation of used contact lenses being returned by consumers\nI hope this answers your inquiry.\nSincerely,\nVohn\nChief, Standards Development\nOffice of Hazardous Materials Standards\n173-134(a)9)\n060098\n\n<<<PAGE 2>>>\n\n84/22/2885 83:33\n8564679643\nSoothe\nPAGE\n01\n313.134\nDefinition Exceptions\npte\nPTP Consulting, Inc. • 1531 Kings Highway • Swedesboro, NJ 0808\n86-0098\nogress Through Pontormana\nONSULTING, INC\n856-467-5400 • Fax: 856-467-9643 • url: http://ehsprogress.com • Info@ehsprogress.com\nApril 22, 2006\nMr. Edward I. Mazzullo\nDirector, Office of Hazardous Materials Standards\nUS DOT/RSPA (DHM-10)\n400 7° St. S. W.\nWashington, DC 20590-0001\nFAX: 202-366-3012\nDear Mr. Mazzullo:\nPTP Consulting has been retained by one of the leading manufacturers of contact lenses to assist with determining\nthe applicability of DOT shipping requirements for used health care products\" under 49CFR $173.134 for Class 6,\nDivision 6.2.\nThe issue under review involves the shipment of a \"used\" contact lens from either the consumer or a health care\nprofessional back to the mamufacturer. Although the manufacturer is not directly responsible as a shipper, they\nbelieve they are obligated to advisc and ensure compliance with DOT shipping requirements of this type of returned\nproduct. Compliance issues under review include training, shipping papers and packaging, which stem frora\ndecision making of the Risk Group numbers. It is undcrstood that this decision process would only apply to health\ncare professionals, since consumers are not covcred under the standard.\nOur questions are two fold:\nQuestion 1. It is up to the shipper to determine the RG number, and it is our opinion that the product is RG1.\nHOWEVCI, we are seeking your opinion and confirmation that our approach in making this determination is consistent\nwith the Department's interpretation of the Standard. The following details our applicability review methodology:\nUnder §173.134 (a)(6), Risk Group 2 is dcfined as a \"pathogen that can cause huran or animal discase but is\nunlikely to be a serious hazard and, while capable of causing serious infection on exposure, for which there are\neffective treatments and preventative measures available and the risk of infection is limitod.\" Risk Group 1 is\ndefined as a \"micro-organism that is unlikely to cause human or animal discasc.\" It is difficult, if not impossible to\nscreen all used contact lenses for pathogens prior to shipment. The conservative approach using good\nmanufacturing practices related to industrial hygiene would be to select RG2, until the next two concepts are taken\ninto consideration:\na. The basic definition of a hazardous material under $171.8 means \"a substance or material that the\nSecretary of Transportation has determined is capable of posing unreasonable risk to health, safcty, and\nproperty when transported in commerce... 1. In our opinion, a used contact lens does not meet this\ndefinition as posing an unreasonable risk. During the normal course of transportation, the chance of a used\ncontact lens posing an unreasonable risk to any highway or air transporter is extremely unlikely unless the\n\n<<<PAGE 3>>>\n\n84/22/2006 03:33\n8564679643\nPAGE 82\npackage was tampered with, opened and an infected lens was deliberately placod on a mucus membrane\n(thc eyeball). But this is not a normal transportation issue.\nb. It is understood that the Department of Transportation regulates hazmat for transportation to ensure\nsafety during loading, transporting and unloading DOT would not govern the safe handling of a used\nhealth care product aftcr it has been received, opened and handled by an employee. The safe handling after\na package has been received at a workplace falls under OSHA. It is our opinion that this act of handling a\nusod contact lons is the only point where there is a degroe af risk, and procedures are already in place to\nensure the product is disinfected before being handled by the manufacturor's employees.\nIs this logic is determining that a usod contact lens is an RGI reasonable and within the intention of what the risk\ngroup determination was meant to govern?\nQuestion 2: Since the manufacturer is not scrving as the shipper, and only the receiver, does it have any\nresponsibilities/ liabilities in making this determination in the first place? As indicated above, the company felt\nobliged to assist the health care professionals, who would be considered the \"shipper\".\nI most sincerely appreciate your prompt attention to this matter, and look forward to your responsc.\nSincerely,\nPTP Consulting, Inc.\nCaroll franky\nPresident\nCarol Brozosky, CET, CHMM","truncated":false,"body_characters":5659}