{"operation":"document","citation":"00-0068","title":"Guidant Corporation — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2000-04-18","effective_on":null,"summary":"00-0068 response to Guidant Corporation concerning 173.448.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-00-0068.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-00-0068.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-00-0068","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2000/000068.pdf","body":"<<<PAGE 1>>>\n\n•\n•\nUS. Department\n400 Seventh Street, S.W.\nof Transportation\nWashington, D.C.\n20590\nSpecial Programs\nAdministration\nAPR I 8 2000\nSam H. Lott, Ph.D.\nRef. No. 00-0068\nRadiation Safety Officer\nGuidant Corporation\n8934 Kirby Drive\nHouston. Texas 77054\nDear Dr. Lott:\nThis is in response to your March 1, 2000, letter requesting clarification on the return shipment of a\nradiotherapy cartridge containing phosphorus-32 encapsulated in a nitinol (nickel-titanium) wire under\nthe Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180). Specifically, you ask whether\nthe shipment of the returned cartridge containing the used wire (approximately 35 mCi) qualifies for\ntransport by passenger-carrying aircraft under provisions in § 173.448(f) of the HMR.\nAccording to your letter, the radiotherapy containing phosphorus-32 encapsulated in nickel-titanium\nwire is used in intravascular radiotherapy for prevention of restenosis following interventional\nprocedures such as balloon angioplasty or stenting. The wire is contained and shielded in a replaceable\ncartridge that is inserted at the customer site in an afterloader for use. The system is used for 3-4 weeks\nin patient treatment and then the cartridge containing the used wire is exchanged for another cartridge\ncontaining a fresh wire.\nSection 173.448(f) provides for the transportation of Class 7 (radioactive) materials by passenger-\ncarrying aircraft if the material is intended for use in, or incident to, research, medical diagnosis or\ntreatment. It is the opinion of this Office that the return shipment of the cartridge containing the used\nwire qualifies as material intended for use incident to medical diagnosis or treatment, and may be\ntransported by passenger-carrying aircraft.\nI hope this answers your inquiry.\nSincerely,\nDelmer F. Billings\nChief, Standards Development\nOffice of Hazardous Materials Standards\n173.448\n- 000068\n\n<<<PAGE 2>>>\n\nGUIDANT\nBoothe\nMarch 1, 2000\n§ 173.448\n00 - 0068\nMr. Edward T. Mazzullo, Director\nOffice of Hazardous Materials Standards DHM-10\nResearch and Special Program Administration\n400 7th Street, S.W.\nWashington, D.C. 20590-0001\nDear Mr. Mazzullo:\nThe Hazardous Material Transportation Regulations state in 49 CFR 173.448(f):\nNo person shall offer for transportation or transport aboard a\npassenger-carrying aircraft any Class 7 (radioactive) material unless that\nmaterial is intended for use in, or incident to, research, medical diagnosis\nThe above regulation was mandated by the Hazardous Material Transportation Act of\nor treatment.\n1974 (49 USC Section 5114).\nGuidant Corporation is involved in intravascular radiotherapy for prevention of restenosis\nfollowing interventional procedures such as balloon angioplasty or stenting. Outgoing\nshipments for radiotherapy contain phosphorus-32 encapsulated in a Nitinol (nickel-\ntitanium) wire. The wire is contained (and shielded) in a replaceable cartridge that is\ninserted at the customer site in an afterloader for use. The system is used for 3-4 weeks\nin patient treatment and then the cartridge containing the decayed wire (approximately\n35 mCi) is exchanged for another cartridge containing a fresh wire.\nIt is desired to facilitate return of the cartridge (includes the wire containing the decayed\nsmaller activity radioactive material for ultimate disposal) for refurbishment and insertion\nof a new wire containing radioactive material. Does the shipment of the returned\ncartridge with the decayed smaller activity radioactive material qualify for transport in\npassenger-carrying aircraft?\nSincerely,\nSam 41. Litt\nSam H. Lott, Ph.D.\nRadiation Safety Officer\nGuidant Vascular Intervention\n713-218-9230\ncc: Mr. Richard W. Boyle\nMr. Wendell Carriker\n8934 Kirby Drive, Houston, TX 77054\nGuidant Corporation\nTel 713.218.9200 Fax 713.218.9280","truncated":false,"body_characters":3808}