{"operation":"document","citation":"16-0200","title":"Teleflex — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2017-03-30","effective_on":null,"summary":"16-0200 response to Teleflex concerning 175.10.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-16-0200.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-16-0200.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-16-0200","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2017/160200.pdf","body":"<<>>\n\nU.S. Department\nof Transportation\nPipeline and Hazardous\nMaterials Safety\nAdministration\n1200 New Jersey Avenue, SE\nWashington, DC 20590\nMAR 3 0 2017\nJay White\nPresident and General Manager\nTeleflex\n3015 Carrington Mill Boulevard\nMorrisville, NC 27560\nReference No. 16-0200\nDear Mr. White:\nThis letter is in response to your December 11 , 2016, letter requesting clarification of the\nHazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to exceptions for\npassengers, crewmembers, and air operators. You describe in your letter a small lithium metal\nbattery contained in both the EZ-IO Intraosseous Infusion system and the OnControl Driver\nsystem, further stating that the battery meets the requirements of each test in the United Nations\n(UN) Manual of Testing and Criteria Part III, Sub-section 38.3 and contains less than 2 grams of\nlithium metal. Specifically, you ask if Teleflex employees are permitted to transport this small\nlithium metal battery, as well as the devices in which it is contained, in carry-on baggage aboard\na passenger aircraft for the purpose of demonstrations and promotional shows.\nThe answer is yes, provided Teleflex employees follow the requirements in § 175.1O(a)(l8). The\nrequirements of this section allow a passenger or crew member to carry a medical device\ncontaining dry cells or dry batteries (including lithium cells or batteries) in either checked or\ncarry-on baggage. Spare lithium batteries must be individually protected to prevent short circuits\n(e.g., placing them in original retail packaging, insulating exposed terminals with tape, or placing\neach battery in a separate plastic bag or protective pouch) and must be placed in carry-on\nbaggage only.\nI hope this information is helpful. Please contact us if we can be of further assistance.\nChief, Standards Development Branch\nStandards and Rulemaking Division\n\n<<>>\n\nDecember 11 , 2016\n)~)!l/{( (\n1.''_7) . /(J~.A .l\nk AC l {---' -\\-- L ~ r \\..,_ -> ®\nl l - · ~ :L ·)(~ lrelef lex\n3015 Carrington Mill Blvd.\nMorrisville, NC 27560\nUSA\nPhone: 919-544-8000\nwww.teleflex .com\nU.S. Department of Transportation\nPipeline and Hazardous Materials Safety Administration\nAttention: PHH-10\nEast Building\n1200 New Jersey Avenue, SE\nWashington, DC 20590\nRequest for Interpretation Letter on 49 CFR § 175.1 O(a)(18)\nDear Sir/Madam:\nI am writing to request a formal interpretation letter on the exceptions in the hazardous materials\nregulations (HMR) found at 49 CFR § 175.1 O(a)(18). This provision applies to passengers or\ncrewmembers when they carry aboard the aircraft for personal use \"portable electronic devices (e.g.,\nwatches, calculating machines, cameras, cellular phones, laptop and notebook computers,\ncamcorders, medical devices etc.) containing dry cells or dry batteries (including lithium cells or\nbatteries) and spare dry cells or batteries for these devices.\" (Emphasis added.)\nTeleflex is a manufacturer of two small, life-saving medical devices known as the EZ-10 lntraosseous\nInfusion system and the OnControl Driver system used in the delivery of fluids and medications to\npatients in the pre-hospital and hospital environments. These devices are powered by a small lithium\nmetal battery that contains less than 2 grams of lithium metal content. The battery has been tested to\nmeet the UN Manual of Tests and Criteria, Part Ill, Sub-section 38.3.\nRepresentatives from Teleflex intend to carry these devices aboard the aircraft for personal use when\ntraveling to give demonstrations at medical facilities and promotional shows. The devices will be\nplaced in customized carrying cases that will protect them from being damaged and inadvertent\nactivation. We note that your office issued a letter to Arie Tillberg with Morpho Detection on March 3,\n2016 (Ref. No. 15-0202) confirming that a small lithium ion battery may be carried aboard the aircraft\nby a Morpho Detection employee who is traveling to show the battery \"for demonstrations and [at]\npromotional shows.\"\nThe Teleflex situation is nearly identical to the one described in your March 3rct letter to Mr. Tillberg\nexcept that it addressed a lithium ion battery rather than a lithium metal battery-powered device.\nTherefore, we request confirmation that the EZ-10 lntraosseous Infusion system and the OnControl\nDriver system with a small lithium metal battery may be transported in carry-on baggage on\npassenger aircraft by Teleflex employees for the purpose of demonstrations and promotional shows.\nThank you for your assistance. I can be reached 919.433.4806 if you have any questions regarding\nthis issue.\nSincerely,\nJay White\nPresident and General Manager\nVascular\n\n<<>>\n\nDodd, Alice (PHMSA)\nFrom:\nSent:\nTo:\nSubject:\nAttachments:\nINFOCNTR (PHMSA)\nMonday, December 19, 2016 4:20 PM\nHazmat Interps\nFW: Request for Interpretation Letter on 49 CFR § 175.10(a)(18)\nJay White- Teleflex_Request_for_\nDOT _Interp_\nLetter 12 19 16-signed.pdf\nHi Shante/ Alice,\nPlease submit this as a letter of interpretation. Please let me know if you have any questions.\nThanks,\nJordan\nFrom: Howington, Kim [mailto:Kim.Howington@teleflex.com]\nSent: Monday, December 19, 2016 10:01 AM\nTo: PHMSA HM lnfoCenter \nCc: gkerchner wileyrein .com ; Ball, Michael ; White, Jay\n\nSubject: Request for Interpretation Letter on 49 CFR § 175.10(a)(18)\nDear Sir/Madam:\nPlease see attached request for Interpretation Letter on 49 CFR § 175.10(a)(18}.\nKindly confirm receipt,\nKim Howington\nExecutive Assistant to Jay White, President\nVascular Division\nP: +1 .919.433.4818 ext. 68.4818\nE: kim.howington@teleflex.com\nTeleflex\n3015 Carrington Mill Blvd ., 6N, Morrisville, NC 27560\nteleflex.com\nThis e-mail message, including any attachment(s), is for the sole use of the intended recipient(s) and may contain confidential, proprietary and/or privileged information. Any unauthorized review, use, disclosure or\ndistribution is prohibited. If you are not the intended recipient, please notify the sender by reply e-mail and delete, and/or otherwise destroy, all copies of the original message, including any attachment(s).","truncated":false,"body_characters":6189}