{"operation":"document","citation":"10-0169","title":"Wiley Rein LLP — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2011-03-03","effective_on":null,"summary":"10-0169 response to Wiley Rein LLP concerning 173.22.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-10-0169.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-10-0169.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-10-0169","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretations/2010/100169.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department of Transportation Pipeline and Hazardous Materials Sq!~1v Administration\nMAR 0 3 2011\n1200 New Jersey Ave, SE\nWashington, D.C. 20590\nMr. George Kerchner\nWiley Rein LLP\n1776 K Street, NW\nWashington, DC 20006\nRef. No. 10-0169\nDear Mr. Kerchner:\nThis responds to your letter regarding the applicability of the Hazardous Materials Regulations\n(HMR; 49 CFR Parts 171-180) to your client's medical devices that contain small amounts of\nhazardous materials. Specifically, you ask whether such devices (copper pipe) used as part of a\nprocess to analyze human blood are subject to the HMR when they may include trace amounts of\ncopper azide in a mixture of salts (copper phosphate, copper oxide, and copper hydroxide). The\nmixture is formed in the copper pipe after flushing it with an aqueous buffer solution containing\nsodium azide, sodium phosphate, sodium biphosphate, and sodium chloride. Your client intends\nto ship approximately ten pieces of the copper pipe submerged in the buffer solution and further\npackaged within small, individual bottles. It is your understanding that copper azide in its pure\nform is a Class 1 (explosive) normally forbidden for transportation in commerce. You also\nbelieve that any residual copper azide that may be on the copper pipe will not be pure copper\nazide, nor will it exhibit any explosive properties.\nUnder § 173.22, it is a shipper's responsibility to properly classify and describe a hazardous\nmaterial. This Office does not normally perform that function. However, it is the opinion of this\nOffice that the trace amounts of copper azide that may be present in your client's copper pipe\ndescribed above is not regulated as a Class 1 explosive. We also agree with your assessment that\nit is not in a form or quantity that poses an unreasonable risk to health and safety or property in\ntransportation and, therefore, is not subject to the HMR.\nI trust this satisfies your inquiry. Please contact us if we can be of further assistance.\nSincerely,\nr~~~\"-\nT. Glenn Foster\nChief, Regulatory Review and Reinvention Branch.\nStandards and Rulemaking Division\n\n<<<PAGE 2>>>\n\n!\n\\Viley\n~~( ~ n\nlLP\n1776 K STREET NW\nWASHINGTON, DC 20006\nPHONE 202.719.7000\nFAX 202.719.7049\n7925 JONES BRANCH DRIVE\nMcLEAN, VA 22102\nPHONE 703.905.2800\nFAX 703.905.2820\nwww.wileyrein.com\nStevens\n~17z. 10 I\nSr73·o~\nDplos,'ve..\n10 -DI(oCj\nGeorge Kerchner\nJuly 28,2010 202.719.4109\ngkerch ner@wileyrein.com\nOffice of Hazardous Materials Standards\nPipeline and Hazardous Materials Safety Administration\nU.S. Department of Transportation\n1200 New Jersey Avenue, SE\nWashington, D.C. 20590\nRe: Classification of Copper Pipe Possibly Containing Copper Azide\nin a Mixture of Salts\nI am writing to request a written confirmation from the Pipeline and Hazardous\nMaterials Safety Administration (PHMSA) regarding the classification of small\namounts of copper azide that may be present on copper tubes used in medical labs.\nWe spoke to Dr. Charles Ke of your office regarding this issue several weeks ago.\nSodium azide-containing aqueous buffer solution often is used in a medical device\nto analyze human blood. The buffer solution also contains sodium phosphate,\nsodium biphosphate, and sodium chloride. The buffer solution is flushed down\nthrough a copper pipe after usage. Because the buffer solution contains sodium\nazide and other salts, there is a small possibility of formation of copper azide along\nwith copper phosphate, copper oxide, and copper hydroxide when the buffer\nsolution flows through the copper pipe while flushing. In fact, possibility of\nformation of copper phosphate is higher than copper azide as copper phosphate is\nmuch less soluble than copper azide in water. These salts are expected to deposit on\nthe inner lining of the copper pipe. In order to confirm or negate the presence of\ncopper azide, estimate the amount of copper azide per unit area of the pipe, and\nconduct a hazard assessment of the copper azide amount in the pipe, it will be\nnecessary to ship small pieces (approximately 0.5-inch-diameter and 1.0-inch-Iong\nin size) of the copper pipe for analysis. Our client is planning to ship approximately\n10 pieces of this copper pipe.\nWe recognize that copper azide may be classified as a Class 1 Explosive hazardous\nmaterial when shipped in its purest form. However, any residual copper azide that\nmay be on the copper pipe as described above will not be pure copper azide or have\nthe properties of a Class 1 Explosive.\nEach piece of copper pipe will be packaged in small, separate bottles and\nsubmerged in the buffer solution inside the bottles. We believe the copper azide\nthat may be present in very small amounts on the copper tube is not in a form or\nquantity that poses an unreasonable risk to health and safety or property in transport.\n\n<<<PAGE 3>>>\n\nJuly 28, 2010\nPage 2\nTherefore, it is our view that the pieces of copper tube are not subject to the\nhazardous materials regulations.\nWe would appreciate written confirmation from PHMSA that our classification of\nthese materials is consistent with the hazardous materials regulations.\nThank you for your assistance.\nSincerely,\nGeorge Kerchner","truncated":false,"body_characters":5159}