{"operation":"document","citation":"14-0086","title":"Fairview Hospital — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2014-07-08","effective_on":null,"summary":"14-0086 response to Fairview Hospital concerning 173.425, 173.436.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-14-0086.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-14-0086.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-14-0086","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2014/140086.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department\nof Transportation\nWashington, D.C. 20590\n1200 New Jersey Avenue, SE\nMaterials Safety\nPipeline and Hazardous\nAdministration\nMs. Christina D. Cahill CNMT, RT(R)\nJUL 0 8 2014\nLead Technologist\nFairview Hospital\n29 Lewis Ave.\nGreat Barrington, MA 01230\nRef. No.: 14-0086\nDear Ms. Cahill:\nThis is in response to your email dated April 18, 2014, requesting clarification of the\nHazardous Materials Regulations (HMR; 49 CFR Parts 171-180) relating to the\ntransportation requirements for radioactive surgical specimens. You state that your\nradioactive specimens have an activity of 1.0 millicuries or less prior to injection, and after\ninjection there is some residual in the syringe. You state that there will be less than 27\nmillicuries of Technetium-99m (Tc-99m) by the time the driver would handle any\nradioactive material. Your questions are paraphrased and answered below:\nQ1: You ask if training for personnel and couriers must comply with the training\nrequirements found in Subpart H of Part 172 of the HMR.\nAl. Section 173.436 sets activity concentrations for exempt material and activity limits\nfor exempt consignments. The activity limit for exempt consignments of Tc-99m is less than\n.27 millicuries. If the only radionuclide present is Tc-99m, and the total activity in the\nconsignment is less than either the activity concentration limit or the activity limit for\nconsignments shown in § 173.436, that consignment would not be considered to be a\nradioactive material under the HMR. Assuming the specimen does not meet the definition of\nany other hazard class, the material is not regulated as a hazardous material and none of the\ntraining requirements of Subpart H of Part 172 of the HMR are applicable.\nQ2.\nSurgical specimens containing Tc-99m can be transported from one RAM licensed\nfacility to another licensed facility as stated in the licenses?\nA2. The licensing you mention does not appear to be an HMR requirement. Please direct\nthis question to the appropriate authority.\nQ3. Must specimens be labeled with a radioactive material label until the less than .27.\nmillicures activity limit is met for \"exemption\"?\n\n<<<PAGE 2>>>\n\nA3. If offered as a fully regulated radioactive material under the HMR, yes, labeling\nwould be required. Depending on the activity present (see § 173.425), your specimens may\nqualify to be offered as Radioactive material, excepted package-instruments or articles, UN\n2910 and further excepted from labeling as a radioactive material.\nQ4. Until a specimen reaches the \"activity limit for exempt consignment\" in accordance\nwith § 173.436, there is no requirement for radioactive labeling?\nA4. See Al.\nI trust this information is helpful. If you have further questions, please do not hesitate to\ncontact this office.\nSincerely,\nShane C. Kelley\nActing International Standards Coordinator\nStandards and Rulemaking Division\n\n<<<PAGE 3>>>\n\nStevens\n• Drakeford, Carolyn (PHMSA)\n3173.436\nSent:\nFrom:\nINFOCNTR (PHMSA)\nTo:\nDrakeford, Carolyn (PHMSA)\nMonday, April 21, 2014 9:46 AM\nRAM\nSubject:\nFW: Tc99m Activity limit for exempt consignment.\n14-0086\nHi Carolyn,\nThis caller requested we submit this e-mail as a formal letter of interpretation.\nThanks,\nVictoria\nFrom: Cahill Christina (Debbie) [mailto:ccahill2@bhs1.org]\nTo: INFOCNTR (PHMSA)\nSent: Friday, April 18, 2014 1:32 PM\nCc: Conroy, Michael (PHMSA); Dillon Bob; Ghani Mazen; HOWIE.GONIA@YAHOO.COM\nSubject: FW: Tc99m Activity limit for exempt consignment.\nMagdy El-Sibaie\nDirector of the Office of Hazardous Materials Standards\nPHMSA's Office of Hazardous Materials\nDear Mr. El-Sibaie,\nI have been in contact with Michael Conroy (Sciences Branch / Division of Engineering and Research / Office of\nHazardous Materials Safety)\nin regards to an issue which needed expedient clarification, so as to not delay patient care. I realize an official position\nresponse can take 6-8 weeks. With his guidance (as shown below with our emails), I believe we do have the clarification\nnecessary and am now requesting the \"official position\" written interpretation to satisfy administration.\nMy question to Mr. Conroy and now you, is in regards to the handling, labeling & transport of radioactive surgical\nspecimens. I have done extensive research and been in communication with the MASS DPH/Radiation Control Program,\nMASS DOT and now the US DOT. If you can confirm the information below, I would appreciate it greatly.\nFrom the information gathered, I am lead to believe:\n1.) Radiation safety training for our personnel and couriers, \"for handling & transporting\" Tc99 radioactive surgical\nspecimens can be provided in-house by our medical physicist.\nNote: (Specimens will have an activity of 1.Omillicuries or less, at the time of injection, there is some residual in\nthe syringe that is not fully injected. There will be less than .27millicuries by the time the driver would handle the\ncontainer.)\n2.) for radiation & transportation purposes, radioactive surgical specimens containing Tc99m, can be transported\nfrom one RAM licensed facility to another licensed facility as stated in the licenses.\n1\n\n<<<PAGE 4>>>\n\n3.) the specimens must be labeled with a radioactive material label UNTIL the less than .27 millicures activity limit is\nmet for \"exemption\".\n4.) when the specimen reaches the \"activity limit for exempt consignment\", in this case Tc99m, less than\n.27millicuries, in accordance with 49 CFR 173.436, there is NO requirement for radioactive labeling,\n5.) NOR is there a requirement for DOT HAZMAT training for \"exempt consignment\" material for personnel handling,\npacking or transporting.\n6.) FYI: Until the \"less than .27mCi activity\" is confirmed, the specimens will be securely stored in a leaded \"transport\ncontainer\" in the Nuclear Medicine hot lab satisfying the UN2910 less than .5mR/hr at the surface of the container.\nPlease advise and respond by email at your earliest convenience, as time is a concern for us in providing safe & quality\npatient care.\nThank you for taking your time to assist me in this matter.\nRespectfully submitted,\nDebbie\nChristina D. Cahill CNMT, RT(R)\nLead Technologist\nFairview Hospital\nDepartment of Nuclear Medicine\n29 Lewis Avenue\nGreat Barrington, MA 01230\nFAX: (4134) 854-9794\nPhone: (413) 854-9757\ndcahill@bhsl.org\nREFERENCE EMAILS WITH MR. CONROY:\nFrom: Cahill Christina (Debbie)\nTo: 'Michael.Conroy@dot.gov'\nSent: Friday, April 18, 2014 10:59 AM\nCc: Dillon Bob; Ghani Mazen; HOWIE.GONIA@YAHOO.COM\nSubject: RE: Tc99m Activity limit for exempt consignment.\nDear Mr. Conroy,\nI appreciate your prompt response to this matter and have submitted a \"written interpretation\" request.\nRE: Figure 2: UN2910 is for \"transport container\" from the OR to NM and storage in the secure hot lab only, until the\nexempt consignment activity is reached. It will not leave the facility. Nothing but specimens confirmed as \"exempt\nconsignment\" will be transported via courier, requiring no radioactive labeling or additional HAZMAT training for\npersonnel.\nThank you for your assistance and clarification.\nDebbie\n2\n\n<<<PAGE 5>>>\n\nFrom: Michael.Conroy@dot.gov [mailto: Michael.Conroy@dot.gov]\nSent: Thursday, April 17, 2014 5:44 PM\nTo: Cahill Christina (Debbie)\nSubject: RE: Tc99m Activity limit for exempt consignment.\nDebbie-\nPlease note: This is not an official \"DOT position.\" If you wish to obtain an \"official position\", this should be done by\nrequesting a written interpretation from the Director of the Office of Hazardous Materials Standards, following the\ndirections in 49 CFR 105.20(a)(4).\nIf I understand your question correctly, you want to know what the DOT requirements are for shipping a specimen that\ncontains less than .27 millicuries of Tc-99m.\nYou are correct that the \"activity limit for exempt consignment\", in this case Tc99m, is less than . 27millicuries, in\naccordance with 49 CFR 173.436.\nPlease note that the exempt limit is for the \"consignment\", so if there are multiple specimens in a consignment, you\nwould need to look at your total activity in all of the specimens in the consignment to see if you are still exempt.\n(\"Consignment\" means a package or group of packages or load of radioactive material offered by a person for transport in\nthe same shipment.)\nIf the only radionuclide present is Tc-99m, and if the total activity in the consignment is less than either the activity\nconcentration limit OR the activity limit in the table in 49 CFR 173.436, that consignment would not be considered to be a\nradioactive material under DOT's Hazardous Materials Regulations (HMR) and no marking, or labeling would be required\nfor transport purposes as radioactive material. (Other non-transportation regulations (e.g., NRC, EPA, OSHA) may apply\nhowever.) If that is all you are preparing for shipment, since it is not regulated under the HMR, there would be no training\nrequired under the DOT HMR.\nI am confused by Figure 2 in one of your attachments that shows a UN2910 label. If you are shipping the exempt\nquantities you describe, that label would not be proper to use. In addition, that is not a DOT label, but is an ICAO label and\nwould only be needed if you were shipping a non-exempt, excepted package by air (as evidenced by reference to\n\"Captain\" at the bottom of the label). If your consignment quantities exceed both the exempt limits cited above, but were\nless than that required to be shipped in a Type A package, they would only need to be marked with UN 2910 (see 49 CFR\n173.422) with no label - you'd add the candy-stripe label for shipping such excepted packages by air.\nIF there are other materials in the shipment that are considered hazardous materials under the HMR, you would need to\nconsider how to properly comply with the HMR for those substances, including training. The information you provided\nindicates that your specimens would be shipped with formalin. Please note, I am NOT the right individual to answer\nquestions on classes other than Class 7, radioactive. If you go to the Hazardous Materials Table in 49 CFR 172.101, you\nwill see an entry for Formalin which will direct you to the entry for Formaldehyde. I am attaching a recent rulemaking that\naddressed shipping formalin. Also, here is a link to a non-DOT article (I cannot vouch for its accuracy!) that addresses\nshipments of formalin that you might find useful:\nhttp://www2.mlo-online.com/features/201204/education-and-training/formaldehyde-shipments-avoid-potential-pitfalls-\nlab-safety.aspx\nIt indicates that depending on the particulars of your shipments, you might be subject to the HMR, including training\nrequirements.\nAdditional information on DOT's requirements for radioactive materials transportation may be found at:\nhttp://www.phmsa.dot.gov/staticfiles/PHMSA/DownloadableFiles/Files/RAM_Regulations_Review_12-2008.pdf\nInformation on DOT training requirements may be found here: http://www.phmsa.dot.gov/hazmat/training/requirements\nLet me know if you need any additional information.\n3\n\n<<<PAGE 6>>>\n\n• Michael Conroy\nSciences Branch / Division of Engineering and Research / Office of Hazardous Materials Safety\nPipeline and Hazardous Materials Safety Administration\nU.S. Department of Transportation\nEast Building, PHH-21\n1200 New Jersey Avenue, S.E.\nWashington, D.C. 20590-0001\nMichael.Conroy@dot.gov\n(202) 366-3597\nFrom: Cahill Christina (Debbie) [mailto:ccahill2@bhs1.org]\nSent: Thursday, April 17, 2014 1:07 PM\nTo: Conroy, Michael (PHMSA)\nSubject: Tc99m Activity limit for exempt consignment.\nCc: HOWIE.GONIA@YAHOO.COM; Dillon Bob\nMr. Michael Conroy\nUS DOT: Radiation Safety\nGood afternoon Mr. Conroy,\nPer our conversation this morning, I am sending the information in regards to the handling, labeling & transport of\nradioactive surgical specimens. I have done extensive research and been in communication with the MASS DPH/Radiation\nControl Program, MASS DOT and now the US DOT. If you can confirm the information below, I would appreciate it greatly.\nI will additionally inquire with a \"Letter of Interpretation\" to follow.\nFrom the information gathered, I am lead to believe:\n1.) Radiation safety training for our personnel and couriers, \"for handling & transporting\" Tc99 radioactive surgical\nspecimens can be provided in-house by our medical physicist.\nNote: (Specimens will have an activity of 1.Omillicuries or less, at the time of injection, there is some residual in\nthe syringe that is not fully injected. There will be less than .27millicuries by the time the driver would handle the\ncontainer.)\n2.) for radiation & transportation purposes, radioactive surgical specimens containing Tc99m, can be transported\nfrom one RAM licensed facility to another licensed facility as stated in the licenses.\n3.) the specimens must be labeled with a radioactive material label UNTIL the less than 27 millicures activity limit is\nmet for \"exemption\".\n4.) when the specimen reaches the \"activity limit for exempt consignment\", in this case Tc99m, less than\n.27millicuries, in accordance with 49 CFR 173.436, there is NO requirement for radioactive labeling,\n5.) NOR is there a requirement for DOT HAZMAT training for \"exempt consignment\" material for personnel handling,\npacking or transporting.\nPlease advise and respond by email at your earliest convenience, as time is a concern for us.\nThank you for taking your time to assist me in this matter of providing quality patient care.\n4","truncated":false,"body_characters":13351}