{"operation":"document","citation":"24-0002","title":"International Isotopes Inc. — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2024-03-27","effective_on":null,"summary":"24-0002 response to International Isotopes Inc. concerning 172.204, 173.448.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-24-0002.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-24-0002.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-24-0002","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/2024-03/240002.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department\nPipeline and Hazardous\nof Transportation\nWashington, DC 20590\n1200 New Jersey Avenue, SE\nMaterials Safety\nAdministration\nMarch 27, 2024\nJohn J. Miller, CHP\nRadiation Safety Officer\nInternational Isotopes Inc.\n4137 Commerce Circle\nIdaho Falls, ID 83401\nReference No. 24-0002\nDear Mr. Miller:\nThis letter is in response to your January 8, 2024, letter and subsequent emails requesting\nclarification of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable\nto a shipper's certificate for radioactive material transported aboard a passenger-carrying aircraft.\nSpecifically, you describe the offering and transportation of shipments containing short-lived\nradiopharmaceuticals—including radioisotopes—that are active pharmaceutical ingredients used\nin the production of radiopharmaceuticals. You explain that you are uncertain regarding the\nreturn shipment of \"empty\" packages intended to be reused for these products when transported\naboard a passenger-carrying aircraft, as many of these packages utilize depleted uranium as\nshielding, which results in the \"empty\" packages being returned for reuse having an external\ndose rate exceeding 0.005 mSv/h (0.5 mrem/h). Furthermore, you explain that this requires the\n\"empty\" packages to be shipped to the radiopharmaceutical's supplier as an LSA-I shipment and\nnot as \"UN2908, Radioactive material, excepted package-empty packaging, 7.\" Therefore,\nregarding the requirement found in § 172.204(c)(4) for the shipper's certificate for radioactive\nmaterial transported aboard a passenger-carrying aircraft, you ask for clarification regarding the\nphrase \"intended for use in, or incident to, research, or medical diagnosis or treatment\" as it\nrelates to these \"empty\" packages.\nNote that § 173.448(f) details the requirement linked to § 172.204(c)(4) and specifies that no\nperson shall offer for transportation aboard a passenger-carrying aircraft any Class 7\n(radioactive) material unless that material is intended for use in, or incident to, research, medical\ndiagnosis, or treatment.\n\n<<<PAGE 2>>>\n\nWe have paraphrased and answered your questions as follows:\nQ1. You ask whether an \"empty\" package that was used for the shipment of\nradiopharmaceuticals containing either residual radioactive material or depleted uranium\nshielding can be considered radioactive material intended for use in, or incident to,\nresearch, or medical diagnosis or treatment when it is returned to the radiopharmaceutical\nsupplier.\nThe answer is yes. It is the opinion of this Office that an \"empty\" package that contains\nresidual radioactive material or depleted uranium shielding as described in your letter that\nis being returned to the radiopharmaceutical supplier for reuse would meet the intent of a\nradioactive material offered aboard a passenger-carrying aircraft for research, medical\ndiagnosis, or treatment.\nQ2.\nYou ask whether disused sealed sources such as Cobalt-57 (Co-57) flood and line\nsources, Germanium-68 (Ge-68) phantoms and line sources, and Sodium-22 (Na-22)\nmarkers that were used in or incidental to medical diagnosis or treatment can be\nconsidered to meet the requirements of being a radioactive material that is intended for\nuse in, or incident to, research, medical diagnosis, or treatment when it is shipped back to\nthe source manufacturer for end-of-life management. When one of these sources is\nreturned to the manufacturer, the contact dose rate on the package can exceed 0.5 mrem/h\nand the source would then be returned as \"UN2915, Radioactive material, Type A\npackage non-special form, non-fissile or fissile excepted, 7.\"\nA2. The answer is yes.\nI hope this information is helpful. Please contact us if we can be of further assistance.\nSincerely,\nDirk Der Kinderen\nChief, Standards Development Branch\nStandards and Rulemaking Division\n\n<<<PAGE 3>>>\n\nBaker\nFrom:\n24-0002\nCc:\nTo:\nINFOCNTR (PHMSA)\nDodd, Alice (PHMSA)\nSubject:\nHazmat Interps\nDate:\nFW: Request for interpretation\nAttachments:\nimage001.png\nWednesday, January 10, 2024 4:49:54 PM\nJJM-2024-02 Request for Interpretation.pdf\nHi Alice,\nPlease see the attached interpretation request.\nLet me know if you need anything.\nRegards,\n-Breanna\nFrom: John J. Miller <jjmiller @intisoid.com>\nSent: Monday, January 8, 2024 2:59 PM\nTo: INFOCNTR (PHMSA) <INFOCNTR.INFOCNTR@dot.gov>\nCc: Sumrall, Matthew (PHMSA) <matthew.sumrall@dot.gov>\nSubject: Request for interpretation\nCAUTION: This email originated from outside of the Department of Transportation (DOT). Do\nnot click on links or open attachments unless you recognize the sender and know the content\nis safe.\nJohn J. Miller\nRadiation Safety & Regulatory Compliance Officer\nM: (208) 589-1580\nT: (208) 524-5300\nInternational Isotopes, Inc. | RadQual\njimiller@intisoid.com\nInternational Isotopes\nINCORPORATED\nVRADQUAL\ninternational iscopes Compai\ninformation that is intended only for the individual or entity named in the e-mail address. If\nyou are not the intended recipient, you are hereby notified that any disclosure, copying,\nreceived this e-mail transmission in error, please reply to the sender, so that we can\ndistribution, or reliance upon the contents of this e-mail is strictly prohibited. If you have\narrange for proper delivery, and then please delete the message from your inbox.\n\n<<<PAGE 4>>>\n\nInternational\nIsotopes\nINCORPORATED\nJanuary 8, 2024\nStandards and Rulemaking Division, Pipeline and Hazardous Materials Safety Administration,\nAttn: PHH-10\nU.S. Department of Transportation, East Building,\n1200 New Jersey Avenue, SE., Washington, DC 20590-0001\nVia email: infocntr@dot.gov\nSubject: Request for an interpretation to § 172.204 (c) (4)\nTo whom it may concern,\nThe purpose of this letter is to formally request an interpretation to the scope of the phrase\n\"incident to medical diagnosis or treatment\" as used in §172.204 (c) (4), which reads.\nRadioactive material. Each person who offers any radioactive material for transportation\naboard a passenger-carrying aircraft shall sign (mechanically or manually) a printed certificate\nstating that the shipment contains radioactive material intended for use in, or incident to,\nresearch, or medical diagnosis or treatment.\nBackground:\nThe use of passenger aircraft is imperative to ensure timely delivery of shipments containing\nshort-lived radiopharmaceuticals, including radioisotopes that are active pharmaceutical\ningredients (APIs) used in the production of those radiopharmaceuticals. These shipments are\nclearly considered to contain radioactive materials intended for use in, or incident to medical\ndiagnosis or treatment and are certified by the shipper to contain radioactive material intended\nfor use in or incidental to medical diagnosis or treatment.\nThe request for interpretation regards the return of empty packagings used for the shipment of\nthese products. Many of these packages are multi-use packages that utilize depleted uranium as\nshielding. On most of these packages, the depleted uranium shield results in an external dose rate\nexceeding 0.005 mSv/h (0.5 mrem/h), which requires the package to be returned to the supplier\nas an LSA-1 shipment and not as an Empty package, UN2908. With a limited package fleet\navailable for use, it is just as important to have these packages returned to the supplier so that\nthey can be reused to ship radiopharmaceuticals or radioisotopes used in the production of\nradiopharmaceuticals.\n208.524.5300\n4137 Commerce Circle\nintisoid.com\nIdaho Falls, Idaho 83401\nradqual.com\n\n<<<PAGE 5>>>\n\nJJM-2024-02\nPage 2 of 2\nQuestion 1: Would the return to supplier of empty packages that had been used for the shipment\nof short-lived radiopharmaceuticals or radioisotope APIs containing residual radioactive material\nor depleted uranium shielding be considered to contain radioactive materials intended for use in,\nor incident to medical diagnosis or treatment?\nA similar scenario occurs with medical devices that contain radioactive materials. Sealed sources\nused in the calibration of patient dosing instrumentation, (dose calibrators) and medical\nimagining devices, patient reference markers, and those used for therapeutical purposes are\nregistered with the US Food and Drug Administration as Class 1 medical devices. When these\nproducts are shipped from the source manufacturer, the use of passenger aircraft ensures timely\ndelivery to the customer. In most cases the customer returns disused sealed sources to the source\nmanufacturer using the package that the new replacement source was provided in. This scenario\nleads to my second question.\nQuestion 2: Would a disused sealed source that had been used in or incidental to medical\ndiagnosis or treatment still be considered to meet the criteria when it is shipped back to the\nsource manufacturer for end of life management?\nPlease contact me by phone at 208 524-5300 or email at jjmiller@intisoid.com if you have any\nquestions regarding this letter or require additional information.\nSincerely,\nJohn J. Miller, CHP\nRadiation Safety Officer\nJJM-2024-02\nCC:\nMr. Matt Sumrall, CHP\nUS Department of Transportation\nPipeline and Hazardous Materials Safety Administration\n1200 New Jersey Avenue SE, Washington, DC, 20590\nVia email.","truncated":false,"body_characters":9193}