{"operation":"document","citation":"09-0018","title":"Bioject, Inc. — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2009-08-17","effective_on":null,"summary":"09-0018 response to Bioject, Inc. concerning 173.4a, 175.10.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-09-0018.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-09-0018.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-09-0018","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretations/2009/090018.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department\nof Transportation\nPipeline and Hazardous Materials\nSafety Administration 1200 New Jersey Ave., SE\nWashington, DC 20590\nAUG 1 7 2009\nMr. David Stark\nPurchasing Supervisor\nBioject, Inc.\n20245 S.W. 95th Avenue\nTualatin, Oregon 97062\nRef. No. 09-001 8\nDear Mr. Stark:\nThis responds to your letter requesting clarification of the Hazardous Materials Regulations\n(HMR; 49 CFR Parts 171-180) as applied to certain carbon dioxide cylinders that are used in\na medical device to administer needle-free injections. Specifically, you ask whether the\ncylinders may continue to be carried on board passenger-carrying aircraft in checked or carry-\non baggage under the exceptions for passengers and crewmembers in !$ 175.10 of the HMR\nand if three previously issued interpretations on the issue (07-0078,02-0193 and 00-0206)\nremain valid. Additionally, you ask whether the cylinders may be offered as cargo to a\npassenger-carrying air carrier under the excepted quantities provisions in 5 173.4a of the\nHMR.\nThe answer to all of your questions is yes. The cylinders may continue to be carried on board\nan aircraft in checked or carry-on baggage by a passenger or crewmember under the personal-\nuse exceptions for non-radioactive medicinal and toilet articles in $ 175.10(a)(l)(i). The\npreviously issued guidance remains valid. Under the provisions for excepted quantities in\n!$ 173.4a, a Division 2.2 gas without a subsidiary hazard that is packaged in a pressure vessel\nwith a water capacity of 30 mL (1.8 cubic inches) or less may be offered for transportation by\nall modes under the conditions specified. Therefore, if the cylinders described in your letter\ncomply with the requirements of !$ 173.4a, they would be eligible for the excepted quantity\nexceptions.\nI trust this satisfies your inquiry. Please contact us if we can be of further assistance.\nSincerelv.\nHattie L. Mitchell\nChief, Regulatory Review and Reinvention\nOffice of Hazardous Materials Standards\n\n<<<PAGE 2>>>\n\nBIOJECT, INC.\n20245 S.W. 95th Avenue\nTUALATIN. OREGON 97062\nTELEPHONE: (503) 692-8001\nFAX: (503) 692JX98\nWWW.BIOJECT.COM\nJanuary 29,2009\nPipeline and Hazardous Materials Safety Administration\nphmsa.webmaster@dot.gov\nRequest for Opinion (See carbon dioxide cartridqe specification below)\n1. Opinion on whether high-pressure Carbon Dioxide UN1013 (C02) cartridges can be shipped within\nthe United States as \"Excepted Quantities\" per CFRI ICAO regulations.\n2. Verification whether a previous opinions (see below 07-0078 and 02-0193) are still valid for C02\ncartridges carried by a passenger, on a passenger aircraft, within the United States.\na. As carry on luggage\nb. Packed in cargo luggage\nBackn round\nBioject is a manufacturer of needle free injection devices used in medical and veterinary applications.\nOne of our devices, the Biojector 82000 http://www.bioiect.com/bioiector2000.html, uses a disposable\npressurized C02 cartridge to operate the device. The cartridge is very similar to any other C02 cartridge\nused in to carbonate beverages (seltzer bottles), or other consumer products.\nThe cartridges are made in Japan by Nittan (Nippon Tansan Gas Co. Ltd.), and distributed in the United\nStates by Leland Limited, Inc., New Jersey.\nBioject ships Biojector products to customers throughout the U.S. and the world. Currently, we have\nbeen the cartridges as ground shipments as a Consumer Commodity, or via air as hazardous material per\n49 CFR instructions.\nQuite often, because the COs is used as a medical product, our customers need immediate shipments.\nThe cost of shipping these products via air as hazardous material is very expensive, nearly $400 for even\none cartridge. This cost is so prohibitive, that out customers are considering discontinuing this product.\nExcepted Quantities\nIt is our opinion that the UN1013 cartridges can be shipped on cargo andlor passenqer aircraft as\n\"Excepted Quantity\", but would like verification from the Department of Transportation.\nNote:\nUN1013 Limited Quantity is Forbidden.\nWe have concluded that the cartridges cannot be shipped as UN2037 due to the high pressures\nproduced by the C02 cartridges.\n\n<<<PAGE 3>>>\n\nPassenner Carrv-on and Luaaane\nWe have previouslv received opinions 07-0078 and 02-0193 (below) regarding carry-on of C02\ncartridges'. After &viewing the current HMR it is not clear to me that these opinions are still valid. Please\nreview and issue an opinion.\nContact Information\nDavid Stark, Purchasing Supervisor\n503-691-4133\ndstark@bioiect.com\nwww.bioiect.com","truncated":false,"body_characters":4522}