{"operation":"document","citation":"10-0039R","title":"Nuclear Diagnostic Products — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2010-04-30","effective_on":null,"summary":"10-0039R response to Nuclear Diagnostic Products concerning 172.101.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-10-0039r.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-10-0039r.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-10-0039r","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretations/2010/100039R.pdf","body":"<<<PAGE 1>>>\n\nU.S. Deportment of Transportation\nPipeline and Hazardous Materials\nSafety Administration\nAPR 3 () 2610 1200 New Jersey Ave, SE\nWashington, D.C. 20590\nMr. Ken Ali\nRadiation Safety Officer\nNuclear Diagnostic Products\n101 Roundhill Drive\nRockaway, NJ 07866\nRef. No.: 10-0039R\nDear Mr. Ali:\nThis responds to your letter concerning whether it is a violation ofthe Hazardous Materials\nRegulations (HMR; 49 CFR Parts 171-180) to place the RQ designation on a Dangerous Goods\nDeclaration for \"Iodine 131\" (131) shipped by aircraft under the HMR.\nAccording to your letter, a small percentage of your company's product is shipped by aircraft via\nFEDEX. For these shipments, you use a Dangerous Goods Declaration, as packages are classed as\nRadioactive Yellow II or Radioactive Yellow III. The main radionuclide your company ships is\n\"Iodine 131\" in a liquid compound form. When shipping \"1-131\" in amounts greater than 1 0\nmillicuries (0.37GBq), you use the RQ designation on packages and shipping documents in\ncompliance with the definition in § 171.8 for hazardous substances listed in § 172.1 0 I, Appendix A,\nTable 2. You ask if your understanding is correct that since the amount being shipped is greater than\nthe RQ for \"1-131\" [0.01 Ci (.00037TBq)] and qualifies as a hazardous substance, the HMR requires\nthat you include the RQ designation on the Declaration ofDangerous Goods document.\nYour understanding is correct. Based on the scenario described above, you are shipping a hazardous\nsubstance as defined in §171.8 since 1-131 is listed in Table 2 to Appendix A in §I 72.101 and you are\nshipping in a quantity in one package in excess of the reportable quantity listed in the table. Thus, the\nletters \"RQ\" are required to be entered on the shipping paper per §1 72.203( c )(2) and shown on the\npackage per § 172.3 24(b).\nI hope this satisfies your inquiry. If we can be of further assistance, please contact us.\n\n<<<PAGE 2>>>\n\n--_, ... A .... IIII/ ..;;-/\"'\\'L-c::-~A-R----------------.. ,-\nWVv. Crt Service • Experience • Reliability\nDIAGNOSTIC\nPRODUCTS\n1126/2010\nMr. Edward Mazzullo\nOffice ofHazardous Materials Safety Administration\nUS Department of Transportation\n122 New Jersey Ave SE\nSuite E 21316\nWashington, DC 20590\nDear Mr. Mazzullo:\nMy name is Ken Ali and I am the Radiation Safety Officer at Nuclear Diagnostic\nProducts(NJ State License 10649/01 and fonner NRC Lic. # 29-30500). This is a\ncommercial nuclear pharmacy located in Rockaway New Jersey, producing radioactive\ndiagnostic imaging drugs for Nuclear Medicine departments at hospitals and other\nmedical institutions.\nA small percentage ofour product is shipped via FedEx in which case we use a\nDangerous Declaration F onn, as packages fall under the DOT classification as\nRadioactive Yellow II or Radioactive Yellow III. The main radionuclide we ship by this\nmethod is Iodine 131 in a liquid compound fonn. When shipping 1-131 amounts greater\nthan 10 millicuries,(0.37GBq)-we use the designation RQ on the package as well as on\nthe shipping manifest /Dangerous Goods Declaration Fonn. This is in compliance with\ntable 2 of49CFR 172.101 that the Reportable Quantity for Iodine 131 is 0.01 Curies(1 0\nmillicuries )or (0.37GBq).\nIt is my interpretation that since the amount being shipped is greater than the RQ amount,\nthe material in question now qualifies as a Hazardous Substance under the definition set\nforth in Section 172.101 paragraph 6 and table 2 and section 171.8-Hazardous Substance\nparagraph 2.\nOn Wednesday January 20, 2010, the Federal Aviation Authority inspected this facility\nand found no violations. As part ofthe general counseling and discussions about fonns\nand changes in the future, we discussed the placement ofthe letters RQ on the Dangerous\nGoods Declaration fonn. Subsequent to the Inspector's visit I received a communication\nfrom him stating that he did not advise using the RQ designation for Class 7 RAM\n(Radioactive Materials)on the manifest. To support his rationale, the inspector cited the\ninterpretation ofPHMSA document Ref.# 05-0247R\n101 Roundhill Drive\nRockawaYt New Jersey 07866\n(973) 664-9696\n(973) 664-9699 Fax\n\n<<<PAGE 3>>>\n\nI was of the opinion that the inspector did not take into consideration the amount (in\nmillicuries) ofmaterial being shipped, which automatically qualifies it as a Hazardous\nSubstance. This is so based on quantity only, regardless ofpresence/absence ofany\nspecific chemical or other harmful properties and must be designated by the RQ marking\non manifest as well as the package.\nOn January 22. 2010, I spoke to Andrew and later Rob from your department who agreed\nwith my interpretation ofthe requirements ofthe regulations with reference to the\ndirective ofReference letter 05-0247R.\nIn a conversation earlier today 112612010, the FAA inspector still maintains the position\nthat the RQ designation is not necessary on our packages even when the radioactive\nmaterial Iodine 131, being shipped exceeds the RQ value of 0.01 Curies.\nWhile I have the utmost respect for the rule and interpretation ofthe letter of the law by\nthe regulatory agencies, I do sincerely believe that there is a slight misinterpretation by\nthe FAA Inspector of the content of your ruling 05-0247R and its applicability to product\nbeing shipped from this facility.\nYour written guidance is now sought as to whether we should continue with the pmctice\nof identifYing RQ amounts on manifests and packages containing greater than\n0.0ICuries(0.37GBq) ofIodine 131, offered for shipment, which my humble\ninterpretation supports, or whether we should discontinue such practice based on the\ncontent of your directive Reference 05-0247R.\n1f\"~~~\n~\nRadiation Safety Officer\nNuclear Diagnostic Products\n101 Roundhill Drive\nRockaway, NJ 07866\nPh. (973)-664-9696\nFax. (973)-664-9699\nE-mail: kena@ndprx.com","truncated":false,"body_characters":5815}