{"operation":"document","citation":"09-0063","title":"Bard Brachytherapy, Inc. — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2009-04-07","effective_on":null,"summary":"09-0063 response to Bard Brachytherapy, Inc. concerning 172.202, 173.421, 173.422.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-09-0063.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-09-0063.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-09-0063","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2009/090063.pdf","body":"<<>>\n\nU.S. Department of Transportation\nPipeline and Hazardous Materials\nSafety Administration\n1200 New Jersey Ave, S.E.\nWashington, D.C. 20590\nMr. Edward A. Zdunek\nBard Brachytherapy, Inc.\n295 E. Lies Road\nCarol Stream, IL 601 88\nRef. No. 09-0063\nDear Mr. Zdunek:\nThis responds to your March 20,2009 letter requesting clarification of the shipping paper\nrequirements for limited quantities of radioactive materials under the Hazardous Materials\nRegulations (HMR; 49 CFR Parts 171 -1 80). Your questions are paraphrased and answered\nbelow.\nQ 1 : In accordance with 8 8 173.42 1 and 173.422, when offering for transportation \"UN29 10,\nRQ, Radioactive material, excepted package-limited quantity of material,\" are shipping\npapers required?\nA1 : The answer is yes. In accordance with 8 173.422, \"Additional requirements for excepted\npackages containing Class 7 (radioactive) materials,\" a Class 7 (radioactive) material that\nmeets the definition of a hazardous substance or a hazardous waste must comply with the\nshipping paper requirements of subpart C of Part 172. However, in accordance with\n173.42 1 (b), a limited quantity of Class 7 (radioactive) material that is also a hazardous\nsubstance or hazardous waste is not subject to the provisions in 4 172.203(d) or\n8 172.204(~)(4).\n42: If 8 172.203(d) is not required when preparing a shipping paper, would we be required to\ncomply with the quantity requirements in 5 172.202(a)(6)?\nA2: The answer is yes. Irrespective of the requirements in 8 172.203(d), for transportation by\naircraft, when preparing a shipping paper for a Class 7 (radioactive) material, the quantity of\nradioactive material must be shown by activity.\n43: Does the shipping description of \"UN2910, RQ, Radioactive material, excepted package-\nlimited quantity of material, Class 7, I- 125 Metal, Solid, Packages X 1\" meet the shipping\npaper activity requirement in 8 1 72.202(a)(6)?\n\n<<>>\n\nA3: The answer is no. For transportation by aircraft, the quantity of radioactive material must be\nshown by activity (i.e., the activity of the radioactive per unit mass of the nuclide).\nI trust this satisfies your inquiry. Please contact us if we can be of further assistance.\nSincerely,\nChief, Regulatory Review and Reinvention\nOfice of Hazardous Materials Standards\n\n<<>>\n\nRadioactive Material License: IL-02062-01\nDevice Registry: IL-1074-S-101-S\nMr. Michael Stevens\nUS DOT\nDear Mr. Stevens,\nI am requesting a letter of interpretation concerning the limited shipping paper requirement for\nthe shipments of Iodine-1 25 (1-1 25) limited quantity, RQ that are made from the Bard\nBrachytherapy Inc. (BBI) facility, Carol Stream, IL. The interpretation I am requesting involves\nwhy BBI is exempted from the additional shipping paper requirements of 172.203(d), which are\nvery detailed, but not exempt from the immediately preceding regulation 172.202(a)(6) a\nnonspecific regulation. I also request the USDOT to review the interpretation that by virtue of\nthe shipping description used the total activity is described.\nBackground\nWe ship the 1-125 limited quantity, RQ with a limited shipping paper. This limited shipping paper\nincludes \"UN2910, RQ, Radioactive material, Excepted Package-Limited Quantity of Material,\nClass 7, 1-125 Metal, Solid, Packages X 1\" on the document.\nIncluded with this letter are copies of inspections by two agencies of the DOT that occurred four\nyears ago within a month of each other. The same shipping paper was reviewed in detail at that\ntime and a copy of the limited shipping paper was given to the inspector, also included. There\nwere no compliance issues with the document at that time. I have reviewed the changes in the\nregulations since that time and have not been able to find any changes to the regulations that\nwould affect the document in question.\nIn November 2008 during an inspection by Orde Duplessis, Hazardous Material Specialist with\nthe Federal Aviation Administration (FAA), an issue concerning regulation 173.421(a)(6) and (b)\nwas identified.\n- The subpart 173.421 (a)(6) refers to 173.422, which identifies further requirements\nspecifically to comply with subpart C of 172 for shipping papers.\n- 173.421 (b) specifically exempts this shipping paper from 172.203(d) and 172.204(~)(4).\n- 172.203(d) is the section that calls out the requirement to identify the radioactive\nmaterial in specific units.\nInterpretation\nI have interpreted the 173.421 (b) exemption to state that there is no requirement to list the\nactivity on the shipping paper. This is a conflict with the less specific requirement in 172.202\n(a)(6). Mr. Duplessis indicated that this does not exempt us from 172.202 (a)(6) which requires\nthat we list the activity on the shipping paper, but does not specifically call out the units required.\n\n<<>>\n\nIf my interpretation above is inaccurate, I would also like to contend that we meet the\nrequirements of 172.202 (a)(6). BBI 's limited shipping paper lists \"UN2910, RQ, Radioactive\nmaterial, Excepted Package-Limited Quantity of Material, Class 7, 1-1 25 Metal, Solid, Packages\nX ?\"as the proper shipping description. I contend that the information present in this shipping\ndescription is a description of activity in the package. Because the radionuclide is listed as I-\n125 the regulations specifically indicate the limited quantity for this radionuclide as 3000 MBq\n(81 mCi) and the RQ value as 370 MBq (10 mCi). The shipping description is an indication of\nactivity within the package. All packages that have this description would have an activity\nbetween 3000 MBq (81 mCi) and the RQ value as 370 MBq (10 mCi) at the time of shipment.\nIf there are any questions about this letter please contact me at (630) 933-7618.\nRSO","truncated":false,"body_characters":5733}