{"operation":"document","citation":"07-0078","title":"Bioject, Inc. — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2007-04-27","effective_on":null,"summary":"07-0078 response to Bioject, Inc. concerning 175.10.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-07-0078.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-07-0078.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-07-0078","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2007/070078.pdf","body":"<<<PAGE 1>>>\n\nS. Depanme\nTransportatic\n400 Seventh Street, S.W.\nWashington, D.C. 20590\nPipeline and\nAdministration\nHazardous Materials Safety\nAPR 27 2007\nMr. Kris Richard\nRA/QA Associate\nRef. No.: 07-0078\n20245 SW 95' Avenue\nBioject, Inc.\nTualatin, OR 97062\nDear Mr. Richard:\nThis is in response to your March 29, 2007 letter requesting clarification of the Hazardous\ncylinders that are used in a medical device to administer needle-free injections. Specifically.\nMaterials Regulations (HMR; 49 CFR Parts 171-180) concerning certain carbon dioxide\nyou ask whether cylinders may continue to be carried on board a passenger-carrying aircraft\nin checked or carry-on luggage under the exceptions in § 175.10 of the HMR.\nOur December 13, 2000 reply (Reference Number 02-0206) to Alaska Airlines remains valid.\nIn that letter we stated that it is our opinion the cylinders may be carried aboard passenger-\ncarrying aircraft in checked or carry-on luggage under the provisions in § 175.10(a)(4)(i). We\nalso stated that the devices do not qualify for the exceptions in §§ 175.10(a)(18) and (a)(25).\nPlease note that in a final rule published March 22, 2006, under Docket HM-228 (71 FR\n14586), we amended the requirements in the HMR for the transportation of hazardous\nmaterials by aircraft. As a result of those amendments, the provisions previously found in\n§ 175.10(a)(4)(i) are now found in $ 175.10(a)(1)(i). Additionally, the provisions previously\nfound in $§ 175.10(a)(18) and (a)(25) are now found in $§ 175.10(a)(12) and (a)(11)\nrespectively.\nI trust this satisfies your inquiry. Please contact us if we can be of further assistance.\nOffee of Hazardous Materials Standards\nSenior Transportation Regulations Specialist\n175.1 0(a)\n070078\n\n<<<PAGE 2>>>\n\nrage 1 Ul 1\nDrakeford\n§ 175.10 (a)IXi)\nJones, Diane <PHMSA>\nAircraft\nFrom:\nHMIS < PHMSA>\n07-0078\nSent:\nFriday, March 30, 2007 10:02 AM\nTo:\nPHMSA Approvals; Jones, Diane <PHMSA>\nSubject:\nFW: Medical device hazardous material travel\nAttachments: CO2 travel letter 2.pdf; CO2 travel letter.pdf\nFrom: Kris Richard [mailto:KRichard@bioject.com]\nTo: HMIS <PHMSA>\nsent: Thursday, March 29, 2007 4:54 PM\nCc: Kris Richard\nSubject: Medical device hazardous material travel\nTo whom it may concern,\nair carriers when they travel. Due to the age of the letters, our customers are beginning to have problems\nApproximately 5 years ago, we received the attached letters from Hattie Mitchell which our customers use with\ntaking their medical device aboard planes.\napproval letter? Your response reference number in the letter is 00-0206.\nWill you please provide me with what information you would need in order for us to receive an updatec\nI appreciate any help you can provide.\nSincerely,\nKris Richard\nBioject, Inc.\nRA/QA Associate\n20245 SW 95th Avenue\nTualatin, OR 97062\n503-691-4152\n4/11/2007\n\n<<<PAGE 3>>>\n\nU.S. Department\nof Transportation\nSEP 2 4 2002\nWashington, D.C. 20590\n400 Seventh St., S.W.\nResearch and\nSpecial Programs\nAdministration\nMr. Tom Brooks\nMaterials Manager\nRef. No. 02-0193\n7620 S.W. Bridgeport Road\nBioject, Inc.\nPortland, Oregon 97224\nDear Mr. Brooks:\ncylinders that are used in a medical device to administer needle-\nThis responds to your letter concerning certain carbon dioxide\ncarried on board a passenger-carrying aircraft in checked or\nfree injections.\nSpecificaliy, you ask if the cylinders may be\ncarry-on luggage under the exception in § 175.10 (a) (4) (i) of the\nHazardous Materials Regulations (HMR; 49 CFR Parts 171-180).\nAirlines remains valid. In that letter we stated that it is our\nOur December 13, 2000 reply (Reference Number 00-0206) to Alaska\nopinion the cylinders may be carried aboard passenger-carrying\n§ 175.10 (a) (4) (i).\naircraft in checked or carry-on luggage under the provision in\nWe also stated that the devices do not\nqualify for the exceptions in S§ 175.10 (a) (18) and 175.10 (a) (25).\nbe of further assistance.\nI trust this satisfies your inquiry. Please contact us if we can\nSincerely,\nHaitie L. Mitchell\nChief,\nOffice of Hazardous Materials Standards\nRegulatory Review and Reinvention\n\n<<<PAGE 4>>>\n\nof Transportation\nU.S. Department\nWashington, D.C. 20590\n400 Seventh St., S.W.\nResearch and\nSpecial Programs\nAdministration\nDEC 13 2000\nMr. Tom Brooks\nBioject, Inc.\n7620 SW Bridgeport Road\nPortland, OR 97224\nDear Mr. Brooks:\nThank you for providing us technical specifications for the Bioject 2000 Needle-Free Injection\nManagement System.\nBased on our evaluation of the Bioject 2000 Needle-Free Injection Management System, it is our\nopinion that this product may be carried aboard passenger-carrying aircraft in checked or carry\non luggage under the provisions in 49 CFR 175.10(a)(4)(i).\nA copy of our response to Alaska Airlines is enclosed. We are returning the confidential\ninformation which you provided and appreciate your making this information available to us.\nSincerely,\nChief, Regulatory Review and Reinvention\nOffice of Hazardous Materials Standards\nEnclosure","truncated":false,"body_characters":4968}