{"operation":"document","citation":"19-0036","title":"Hazmat Safety Consulting — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2020-03-10","effective_on":null,"summary":"19-0036 response to Hazmat Safety Consulting concerning 173.22.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-19-0036.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-19-0036.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-19-0036","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/docs/standards-rulemaking/hazmat/interpretations/73541/190036.pdf","body":"<<>>\n\nU.S. Department\nof Transportation\nPipeline and Hazardous\nMaterials Safety\nAdministration\n1200 New Jersey Avenue, SE\nWashington, DC 20590\nMarch 10, 2020\nBob Richard\nPresident\nHazmat Safety Consulting\n5724 North Pulaski Road\nChicago, IL 60646\nReference No. 19-0036\nDear Mr. Richard:\nThis letter is in response to your March 15, 2019, email requesting clarification of the Hazardous\nMaterials Regulations (HMR; 49 CFR Parts 171-180) applicable to a glucose monitoring health\ncare product. Specifically, you describe the device and its handling, as follows, and ask whether\nit should be transported as a Division 6.2, medical waste or used healthcare product:\n• The device has a very small sharp that is imbedded in a hard-plastic casing and is not\naccessible;\n• The sharp only penetrates the outer level of skin when the spring-loaded applicator is\npressed against the skin, and a patch is applied;\n• Following use, the device and patch are sent for recycling to a designated collection site;\n• A return kit is provided to the user and they are instructed to rinse the device prior to\nplacing it in the packaging and shipping for recycling.\nIn accordance with§ 173.22, it is the shipper's responsibility to properly classify a hazardous\nmaterial and this Office does not normally perform this function. That said, in the absence of\nexplicit instruction from the manufacturer to fully inform the customer on pathogen concerns and\nhow to disinfect the device, there are three potential shippbig scenarios for the user returning the\nkit:\n1. If the person returning the kit determines that the device is not known or reasonably\nexpected to contain a pathogen, either because the user has not exposed the device to a\npathogen or has disinfected it, then it does not meet the definition of a Division 6.2\ninfectious substance and does not need to be shipped as a hazardous material. Note, the\ninstruction to rinse the device may not be sufficient to remove a pathogen.\nIf the person returning the kit has knowledge or a reasonable expectation that the device contains\na pathogen, the device may not be offered for transportation without being appropriately\nclassified, described, and packaged as a Division 6.2 infectious substance.\n\n<<>>\n\n2. 3. If the person returning the kit determines that the device is known or reasonably expected\nto contain a pathogen that meets the definition of a Category B infectious substance, it\nmust be shipped as \"UN3291, Regulated medical waste, n.o.s., 6.2, II.\" ·\nIf the person returning the kit determines that the device is known or reasonably expected\nto contain a pathogen that meets the definition of a Category A infectious substance, it\nmust be shipped as \"UN2814, Infectious substances, affecting humans, 6.2.\"\nThe accompanying brochure, \"Transporting Infectious Substances Safely,\" maYassist your client\nin providing instruction to the customer in making the determination if the return kit must be\nshipped as containing a hazardous material. Customers may also wish to seek assistance mi\nclassification and packaging requirements from the common carrier that they are using to ship\nthe return kit. '\nI hope this information is helpful. Please contact us if we can be of further assistance.\nirk r eren\nChief, Standards Development Branch\nStandards and Rulemaking Division\n\n<<>>\n\nDodd, Alice (PHMSA)\nFrom: Foster, Glenn (PHMSA)\nSent: To: Cc: Wednesday, March 27, 2019 3:18 PM\nDodd, Alice (PHMSA); January, Ikeya CTR (PHMSA)\nDerKinderen, Dirk (PHMSA); Foster, Glenn (PHMSA); Kelley, Shane (PHMSA); Nickels,\nMatthew (PHMSA)\nSubject: Glucose monitor\nAlice/ lkeya\nPlease have the email from Bob Richard checked in as a request for an lnterp and assign to a Specialist.\nThanks,\nGlenn\nFrom: Kelley, Shane (PHMSA)\nSent: Wednesday, March 27, 2019 10:20 AM\nTo: Foster, Glenn (PHMSA) \nSubject: FW: Glucose monitor\nCan you call Bob today and see if you think we should accept a meeting request? I am ok either way, just want to close\nthe loop!\nThanks\nFrom: Edmonson, Eileen (PHMSA)\nSent: Friday, March 15, 2019 2:54 PM\nTo: Bob Richard \nCc: Kelley, Shane (PHMSA) ; Foster, Glenn (PHMSA) ; Mike Pagel\n; Pfund, Duane (PHMSA) \nSubject: RE: Glucose monitor\nHi Bob,\nHope all is going well.\nI've forwarded your request for a meeting to discuss the glucose monitor described below to' PHH-10 and -13 leadership\nfor consideration.\nWe will get back to you soon.\nSincerely,\nEileen Edmonson\nTransportation Regulations Specialist\nU.S. Department of Transportation/PHMSA\n(w) 202~ 366-4481\n(f) 202-366-7041\n(email) eileen.edmonson@dot.gov\n1\n\n<<>>\n\n(Hazmat Info Center) 800-467-4922\n(website) https://www.phmsa.dot.gov/\nFrom: Bob Richard \nSent: Friday, March 15, 2019 1:41 PM\nTo: Edmonson, Eileen (PHMSA) \nCc: Kelley, Shane (PHMSA) ; Foster, Glenn (PHMSA) ; Mike Pagel\n\nSubject: Glucose monitor\nEileen,\nMy client has a health care product that is used for glucose monitoring. Because of FDA approval requirements once the\nproduct is used the patient cannot simply dispose of it in regular municipal waste streams even though the likelihood\nthat it contains a pathogen is extremely remote. The device has a very small sharp that is not accessible in transport or\nto the user because it is imbedded in a hard plastic casing and is retracted to prevent inadvertent exposure. The skin\npiercing mechanism is imbedded in a hard robust casing and not accessible. The sharp only penetrates the outer level of\nskin when the spring loaded applicator is pressed against the skin. The device applies a patch to the pierced skin that\ncan monitor glucose levels for up to two weeks. This video shows how the product works:\nhttps://www.freestylelibre.us/support/overview.html click apply the sensor.\nOnce the device is used and the patch is removed the patient is instructed to send it for recycling to a designated\ncollection site. The patient is provided with a return kit and instructed to rinse the product prior to placing it in the\npackage and shipping it further eliminating any chance that it contains a pathogen. I believe that on the basis that the\ndevice is unlikely to contain a pathogen it should not be considered a Division 6.2 substance. I don't believe it should be\nrequired to be transported as a medical Waste or used healthcare product. I could apply for a written interpretation but\nI think it would make more sense to demonstrate how the product is used, packaged and transported either by coming\nin for a face to face meeting or scheduling a WebEx prior to submitting a request for an interpretation. I would like to\nschedule a time to provide a presentation where we can provide a demonstration of the product and the shipping\nprocess. The client is a company that has a strong safety culture and compliance program. The product does not\ngenerate a significant profit for the company. They distribute as an altruistic initiative to promote public health and in\nthe interest of their customers. If they would need to ship the used kits back as a regulated commodity they would not\nlikely to distribute the product which would be unfortunate for potential users. ·\nBest Regards,\nBob Richard\nPresident, Hazmat Safety Consulting\nPhone: 773-540-0837\nEmail: brichard@hazmatsafety.com\nwww.hazmatsafety.com\n. ,\nCONFIDENTIALITY NOTICE: This transmission is intended only for the use of the individual or entity to which it is addressed and may\ncontain information that is privileged and confidential. If the reader of this message is not the intended recipient, you are hereby\nnotified that any disclosure, distribution or copying of this information is strictly prohibited. If you have received this transmission in\nerror, please notify us immediately by telephone and delete the original message.\n2\n\n<<>>\n\nFrom: Edmonson, Eileen (PHMSA) \nSent: Friday, March 1, 2019 2:22 PM\nTo: Bob Richard \nCc: Kelley, Shane (PHMSA) ; Foster, Glenn (PHMSA) \nSubject: RE: Have time for a quick question today?\nHello Bob,\nI found two letters of clarification, one linked and the other attached as a PDF, PHMSA issued in the past on \"Used\nhealth care products.\" I believe they address your question. However, these letters are older, so some of the section\nreferences may have changed.\n4/2/2012 Ref No 12-0028\nhttps:ljwww.phmsa.dot.gov/regulations/tit1e49/interp/12-0028\nIf you need additional information, please let us know by \"replying\" all to this message.\nThanks,\nEileen Edmonson\nTransportation Regulations Specialist\nU.S. Department of Transportation/PHMSA\n(w) 202-366-4481\n(fl 202-366-7041\n(email) eileen.edmonson@dot.gov\n(Hazmat Info Center) 800-467-4922\n(website) https://www.phmsa.dot.gov/\nFrom: Bob Richard \nSent: Tuesday, February 26, 2019 12:37 PM\nTo: Edmonson, Eileen (PHMSA) \nCc: Kelley, Shane (PHMSA) \nSubject: FW: Have time for a quick question today?\nEileen,\nI am hoping you can assist me. I have a client that needs to have their glucose monitors returned from patients. The\nclient will provide the patients with return kits. The devices will be sent to a facility for recycling. I am trying to\ndetermine if they can ship the devices as \"used health care products\" or as \"regulated medical devices\". Please note the\ninformation below.\nhttps:ljwww.freestylelibre.us/system-overview /freestyle-14-day.htm I\n3\n\n<<>>\n\nDiscover the Freestyle Libre 14 day system\nGet ready to make fingersticks a thing of the pastr\nWhat is it?\nTI'le F1eeSt;1e u01e 1.: cay system ,s a continuous glucose monitoring system\ncons1st1ng of n handheld reader and J sensor worn on the DJCk of th~ upper arm\nHow does it work?\nThe sensor uSes a ttw,. nex11Ye f;kin1ent lf'lS~teo iust l,noer tho= skin to measure\nglucose every minute\nHow do you use it?\nUSe tt1e hanc:t~ld reaaei to scan tl1e sensor w,th a painless,~ one-second scan to\nreplact f1 rt9t:rSt1CkS •\nThe middle photo shows a side view of the sensor. The sensor is 26 mm in diameter, and \"thin, flexible filament\"\nprotrudes 5 mm from the base of the sensor.\nA video showing how the sensor is applied is included here:\nhttps://www.freestylelibre.us/support/overview.html\nPrior to insertion in the skin, the thin filament is nested in annular-shaped stainless steel sharp. The fully extended, the\nstainless sharp injects into the skin~ 7mm, and then immediately retracts into the applicator unit, leaving the thin\nfilament in the skin. Part of the FDA filing required Abbott proving that the stainless steel sharp reliably retracts so that\nthe sharp is no longer exposed.\nRegulated medical waste or clinical waste or (bio) medical waste means a waste or reusable material derived\nfrom the medical treatment of an animal or human, which includes diagnosis and immunization, or from biomedical\nresearch, which includes the production and testing of biological products. Regulated medical waste or clinical\nwaste or (bio) medical waste containing a Category A infectious substance must be classed as an infectious\nsubstance, and assigned to UN2814 or UN2900, as appropriate.\nUsed health care product means a medical, diagnostic, or research device or piece of equipment, or a personal\ncare product used by consumers, medical professionals, or pharmaceutical providers that does not meet the\ndefinition of a patient specimen, biological product, or regulated medical waste, is contaminated with potentially\ninfectious body fluids or materials, and is not decontaminated or disinfected to remove or mitigate the infectious\nhazard prior to transportation.\nExceptions\n(12) Laundry and medical equipment and used health care products, as follows:\n(i) Laundry or medical equipment conforming to the regulations of the Occupational Safety and Health\nAdministration of the Department of Labor in 29 CFR 1910.1030. This exception includes medical equipment\nintended for use, cleaning, or refurbishment, such as reusable surgical equipment, or equipment used for testing\nwhere the components within which the equipment is contained essentially function as packaging. This exception\ndoes not apply to medical equipment being transported for disposal.\n4\n\n<<>>\n\nshipping for recycling not disposal.\n(ii) Used health care products not conforming to the requirements in 29 CFR 1910.1030 and being returned to\nthe manufacturer or the manufacturer's designee are excepted from the requirements of this subchapter when\noffered for transportation or transported in accordance with this paragraph (b)(12). For purposes of this paragraph, a\nhealth care product is used when it has been removed from its original packaging. Used health care products\ncontaminated with or suspected of contamination with a Category A infectious substance may not be transported\nunder the provisions of this paragraph.\n(A) Each used health care product must be drained of free liquid to the extent practicable and placed in a\nwatertight primary container designed and constructed to assure that it remains intact under conditions normally\nincident to transportation. For a used health care product capable of cutting or penetrating skin or packaging\nmaterial, the primary container must be capable of retaining the product without puncture of the packaging under\nnormal conditions of transport. Each primary container must be marked with a BIOHAZARD marking conforming to\n29 CFR 1910.1030(g)(1 )(i).\n(B) Each primary container must be placed inside a watertight secondary container designed and constructed to\nassure that it remains intact under conditions normally incident to transportation. The secondary container must be\nmarked with a BIOHAZARD marking conforming to 29 CFR 1910.1030(g)(1)(i).\n(C) The secondary container must be placed inside an outer packaging with sufficient cushioning material to\nprevent movement between the secondary container and the outer packaging. An itemized list of the contents of the\nprimary container and information concerning possible contamination with a Division 6.2 material, including its\npossible location on the product, must be placed between the secondary container and the outside packaging.\n(D) Each person who offers or transports a used health care product under the provisions of this paragraph\nmust know about the requirements of this paragraph.\nBest Regards,\nBob Richard\nPresident, Hazmat Safety Consulting\nPhone:773-540-0837\nEmail: brichard@hazmatsafety.com\nwww.hazmatsafety.com\nCONFIDENTIALITY NOTICE: This transmission is intended only for the use of the individual or entity to which it is addressed and may\ncontain information that is privileged and confidential. If the reader of this message is not the intended recipient, you are hereby\nnotified that any disclosure, distribution or copying of this information is strictly prohibited. If you have received this transmission in\nerror, please notify us immediately by telephone and delete the original message.\n5","truncated":false,"body_characters":15207}