Bioject, Inc. — Hazardous Materials Safety Interpretation

Page 1S. Depanme Transportatic 400 Seventh Street, S.W. Washington, D.C. 20590 Pipeline and Administration Hazardous Materials Safety APR 27 2007 Mr. Kris Richard RA/QA Associate Ref. No.: 07-0078 20245 SW 95' Avenue Bioject, Inc. Tualatin, OR 97062 Dear Mr. Richard: This is in response to your March 29, 2007 letter requesting clarification of the Hazardous cylinders that are used in a medical device to administer needle-free injections. Specifically. Materials Regulations (HMR; 49 CFR Parts 171-180) concerning certain carbon dioxide you ask whether cylinders may continue to be carried on board a passenger-carrying aircraft in checked or carry-on luggage under the exceptions in § 175.10 of the HMR. Our December 13, 2000 reply (Reference Number 02-0206) to Alaska Airlines remains valid. In that letter we stated that it is our opinion the cylinders may be carried aboard passenger- carrying aircraft in checked or carry-on luggage under the provisions in § 175.10(a)(4)(i). We also stated that the devices do not qualify for the exceptions in §§ 175.10(a)(18) and (a)(25). Please note that in a final rule published March 22, 2006, under Docket HM-228 (71 FR 14586), we amended the requirements in the HMR for the transportation of hazardous materials by aircraft. As a result of those amendments, the provisions previously found in § 175.10(a)(4)(i) are now found in $ 175.10(a)(1)(i). Additionally, the provisions previously found in $§ 175.10(a)(18) and (a)(25) are now found in $§ 175.10(a)(12) and (a)(11) respectively. I trust this satisfies your inquiry. Please contact us if we can be of further assistance. Offee of Hazardous Materials Standards Senior Transportation Regulations Specialist 175.1 0(a) 070078#

Page 2rage 1 Ul 1 Drakeford § 175.10 (a)IXi) Jones, Diane <PHMSA> Aircraft From: HMIS < PHMSA> 07-0078 Sent: Friday, March 30, 2007 10:02 AM To: PHMSA Approvals; Jones, Diane <PHMSA> Subject: FW: Medical device hazardous material travel Attachments: CO2 travel letter 2.pdf; CO2 travel letter.pdf From: Kris Richard [mailto:KRichard@bioject.com] To: HMIS <PHMSA> sent: Thursday, March 29, 2007 4:54 PM Cc: Kris Richard Subject: Medical device hazardous material travel To whom it may concern, air carriers when they travel. Due to the age of the letters, our customers are beginning to have problems Approximately 5 years ago, we received the attached letters from Hattie Mitchell which our customers use with taking their medical device aboard planes. approval letter? Your response reference number in the letter is 00-0206. Will you please provide me with what information you would need in order for us to receive an updatec I appreciate any help you can provide. Sincerely, Kris Richard Bioject, Inc. RA/QA Associate 20245 SW 95th Avenue Tualatin, OR 97062 503-691-4152 4/11/2007#

Page 3U.S. Department of Transportation SEP 2 4 2002 Washington, D.C. 20590 400 Seventh St., S.W. Research and Special Programs Administration Mr. Tom Brooks Materials Manager Ref. No. 02-0193 7620 S.W. Bridgeport Road Bioject, Inc. Portland, Oregon 97224 Dear Mr. Brooks: cylinders that are used in a medical device to administer needle- This responds to your letter concerning certain carbon dioxide carried on board a passenger-carrying aircraft in checked or free injections. Specificaliy, you ask if the cylinders may be carry-on luggage under the exception in § 175.10 (a) (4) (i) of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180). Airlines remains valid. In that letter we stated that it is our Our December 13, 2000 reply (Reference Number 00-0206) to Alaska opinion the cylinders may be carried aboard passenger-carrying § 175.10 (a) (4) (i). aircraft in checked or carry-on luggage under the provision in We also stated that the devices do not qualify for the exceptions in S§ 175.10 (a) (18) and 175.10 (a) (25). be of further assistance. I trust this satisfies your inquiry. Please contact us if we can Sincerely, Haitie L. Mitchell Chief, Office of Hazardous Materials Standards Regulatory Review and Reinvention#

Page 4of Transportation U.S. Department Washington, D.C. 20590 400 Seventh St., S.W. Research and Special Programs Administration DEC 13 2000 Mr. Tom Brooks Bioject, Inc. 7620 SW Bridgeport Road Portland, OR 97224 Dear Mr. Brooks: Thank you for providing us technical specifications for the Bioject 2000 Needle-Free Injection Management System. Based on our evaluation of the Bioject 2000 Needle-Free Injection Management System, it is our opinion that this product may be carried aboard passenger-carrying aircraft in checked or carry on luggage under the provisions in 49 CFR 175.10(a)(4)(i). A copy of our response to Alaska Airlines is enclosed. We are returning the confidential information which you provided and appreciate your making this information available to us. Sincerely, Chief, Regulatory Review and Reinvention Office of Hazardous Materials Standards Enclosure#