{"operation":"document","citation":"18-0059","title":"Global First — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2018-09-13","effective_on":null,"summary":"18-0059 response to Global First concerning 171.2, 172.101, 173.134, 173.22.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-18-0059.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-18-0059.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-18-0059","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/docs/standards-rulemaking/hazmat/interpretations/68861/180059.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department\nof Transportation\nPipeline and Hazardous\nMaterials Safety\nAdministration\n1200 New Jersey Avenue, SE\nWashington, DC 20590\nSEP 1 3 2018\nMr. Thomas Brennan\nVice President\nStrategic Accounts & Life Sciences\nGlobal First\n10337 Allen Road\nPickerington, OH 43147\nReference No. 18-0059\nDear Mr. Brennan:\nThis letter is in response to your April 16, 2018, email requesting clarification of the Hazardous\nMaterials Regulations (HMR; 49 CFR Parts 171-180) applicable to transporting cadaveric\nspecimens. You ask for written confirmation of answers you received during an April 13, 2018,\ntelephone conversation with a member of my staff.\nYou state the specimens are tested and determined to not contain bloodbome pathogens;\ntherefore, they are considered non-infectious. In an April 13, 2018, telephone conversation with\na member of my staff you also state the specimens do not meet any other hazard class, but when\ntransported in formalin, they are described as \"UN3373, Biological substance, Category B, 6.2\n(infectious substance).\"\nWe have paraphrased your questions and answered them as follows:\nQ 1. You seek confirmation of your understanding that cadaveric tissues, corpses, human\nremains, and anatomical parts used in research and education to and/or from biomedical\nskills laboratories are excepted from§ 173.134(b)(l), (b)(5), and (b)(14) of the HMR\napplicable to Division 6.2 (infectious substance).\nAl. You are correct that§ 173.134(b)(14) provides that corpses, remains, and anatomical\nparts intended for interment, cremation, or medical research at a college, hospital, or\nlaboratory are not subject to the requirements of the HMR as Division 6.2 materials.\nFurther, a material that is not known or suspected to contain an infectious substance and\ndoes not meet the definition of another hazardous material is not regulated under the\nHMR (see §§ 171.2(k) and 173.134(b )(1 )-(5)). Provided the described materials do not\nmeet the definition of any other hazard class or division, the transportation of the remains\nis not regulated under the HMR.\n\n<<<PAGE 2>>>\n\nQ2. A2. Q3. A3. You note that the cause of death is sometimes determined after transportation has ended.\nYou ask if a material may be considered non-infectious and not further regulated as a\nDivision 6.2 material in transportation in commerce if the cause of death is found to not\nrequire the material to be transported as a Division 6.2, Category A or B material,\ne.g., from pneumonia or sepsis.\nSection 172.101 ( c )(11) permits a material for which the hazard class is uncertain and\nwhich must be determined by testing to be assigned a tentative proper shipping name,\nhazard class, identification number and packing group, if applicable, based on the\nshipper's tentative determination (see§ 173.22). If a shipper determines, based on their\nknowledge of the material, that it is non-hazardous, the provisions of the HMR do not\napply to that material.\nYou seek confirmation of your understanding that it is a violation of the HMR to\ndesignate non-infectious cadaveric specimens as \"UN3373, Biological substances,\nCategory B, 6.2.\"\nSection 171.2(k) states that no person may, by marking or otherwise, represent that a\nhazardous material is present in a package, container, motor vehicle, rail car, aircraft, or\nvessel if the hazardous material is not present.\nI hope this information is helpful. Please contact us if we can be of further assistance.\nSincerely,\nT. Glenn Foster\nChief, Regulatory Review and Reinvention Branch\nStandards and Rulemaking Division\n2\n\n<<<PAGE 3>>>\n\nJanuary, lkeya CTR (PHMSA)\nFrom:\nSent:\nTo:\nSubject: Importance: High\nEdmonson, Eileen (PHMSA)\nMonday, April 16, 2018 3:51 PM\nJanuary, Ikeya CTR (PHMSA)\nFW: 49 CFR 173.134 Interpretation\nHi lkeya,\nCan you please log the letter below in and assign it to me?\nMany thanks,\nEileen Edmonson\nUSDOT/PHMSA\n(202) 366-4481 (work)\n(202) 366-8553 (main)\n(202) 366-7041 (fax)\n1-800-467-4922 (HazMat Info Center)\neileen.edmonson@dot.gov (e-mail)\ninfocntr@dot.gov (HMIC e-mail)\nFrom: Tom Brennan [mailto:tbrennan@globalfirst.biz]\nSent: Monday, April 16, 2018 2:31 PM\nTo: Edmonson, Eileen (PHMSA) <eileen.edmonson@dot.gov>\nSubject: 49 CFR 173.134 Interpretation\nImportance: High\nEileen,\nThank you again for the phone call on Friday to discuss 49 CFR 173.134 and in particular the transport of Cadaveric\nSpecimens and thank you for your support in helping me clearly understand the DOT's regulations governing the\ntransportation of Exempt Human Specimens.\nWe are sometimes asked by customers about the DOT's regulations surrounding the transport of Cadaveric tissues,\nCorpses, Human remains and anatomical parts used in research and education to/from Bio Skills labs. These specimens\nhave been serologically tested for infectious diseases such as HIV, Hepatitis Band Hepatitis C and are found to be\nnegative.\nIt is my understanding that these specimens would be exempt from these 6.2 regulations based on 49 CFR 173.134 (b),\n(1), (5), or (14)\n173.134 Class 6, Division 6.2-Definitions and exceptions.\n(b) Exceptions. The following are not subject to the requirements of this subchapter as Division 6.2 materials:\n(1) A material that does not contain an infectious substance or that is unlikely to cause disease in humans or anima ls.\n(5) A material with a low probability of containing an infectious substance, or where the concentration of the infectious\nsubstance is at a level naturally occurring in the environment so it cannot cause disease when exposure to it occurs.\nExamples of these materials include: Foodstuffs; environmental samples, such as water or a sample of dust or mold; and\nsubstances that have been treated so that the pathogens have been neutralized or deactivated, such as a material\ntreated by steam sterilization, chemical disinfection, or other appropriate method, so it no longer meets the definition\nof an infectious substance.\n1\n\n<<<PAGE 4>>>\n\n(14) Corpses, remains, and anatomical parts intended for interment, cremation, or medical research at a college,\nhospital, or laboratory.\nAdditionally, the cause of death can, at times, be determined after transport to be from Pneumonia or Sepsis but this\nstill does not constitute a requirement to transport as a 6.2 Category A or Bas these are not part of the group defined as\ninfectious substances.\nLastly, it is my understanding that to classify and ship specimens that fit under the 49 CFR 173.134 (b), (1), (5), or (14)\nexception as UN 3373 shipments within and of itself would be a violation of these rules and in times of emergencies take\nfocus away from what is really a UN3373 or other hazards.\nI thank you again Eileen for your time and education.\nRegards,\n~e~\nVice President Strategic Accounts & Life Sciences\n61aballlRS1\nP~t!'f11Clt:t\nProviding Mission Critical Solutions For Time Sensitive Needs\n(614) 582-2452: Cell\n(614) 829-3949: Office\n(800) 995-2210: Customer Service\n(718)504-3680: Fax\nTbrennan@globalfirst.biz : Email\nwww.globalfirst.biz\n2","truncated":false,"body_characters":6983}