{"operation":"document","citation":"11-0314","title":"BioStorage Technologies — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2012-03-06","effective_on":null,"summary":"11-0314 response to BioStorage Technologies concerning 171.22, 171.23, 171.24, 173.134.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-11-0314.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-11-0314.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-11-0314","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretations/2011/110314.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department 1200 New Jersey Avenue SE\nof Transportation Washington. DC 20590\nPipeline and Hazardous\nMaterials Safety\nAdministration\nMs. Darcy Britt\nGlobal Logistics Compliance Supervisor\nBioStorage Technologies\n2910 Fortune Circle West Drive, Suite E\nIndianapolis, IN 46241\nReference No. 11-0314\nDear Ms. Britt:\nThis is in response to your December 19, 2011 letter requesting clarification of the\nHazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to human\nspecimens collected from multiple patients at their residences as part of a clinical trial to\ndevelop diagnostic tests for detecting colon cancer or pre-cancerous cells.\nSpecifically, you state when a sufficient number of the samples have been collected, the\nparent company conducting the study ships them in bulk packages on dry ice to a thirdparty\nwarehouse where they are held for long-term storage at -80°C. You also state at a\nfuture date these samples will be shipped from the third-party warehouse to a clinical\nlaboratory for routine testing, but at no point will they be tested to determine their hazard\nclass - so it is unknown. In addition, you state the parent company employees are hazmat\ntrained in accordance with 49 CFR Part 172, Subparts H (training) and I (security), and\nhave determined the proper classification of the specimens is \"Exempt Human Specimen,\"\na designation authorized under Section 6.3.2.3.6 of the International Civil Aviation\nOrganization (leAO) Technical Instructions for the Safe Transportation of Dangerous\nGoods by Air (Technical Instructions). We have paraphrased your questions and answered\nthem in the order you provided.\nQ1. Do batched shipments of numerous, different patient specimens classed by trained\npersonnel as \"Exempt Human Specimen,\" and shipped in bulk packages from a\nparent company to a third-party warehouse for long-term, ultra-cold storage qualify\nas excepted from regulation under the HMR in conformance with\n§ 173.134(b)(1l)?\nAI. The answer is yes. Under § 173.134(b)(1l), a human or animal sample being\ntransported for routine testing not related to the diagnosis of an infectious disease\nand for which there is a low probability that the sample is infectious is not subject\nto regulation under the HMR. For your information, please note that \"Exempt\nHuman Specimen\" is not a hazard class or wording that appears in the HMR. It is a\n\n<<<PAGE 2>>>\n\n02. marking required under Part 2, Chapter 6, § 6.3.2.3.6 of the ICAD Technical\nInstructions for patient specimens for which professional judgment has been used\nto determine that there is minimal likelihood pathogens are present, and the\nspecimens are packaged in conformance with that section and offered or intended\nfor transportation by aircraft. 49 CFR Part 171, Subpart C, and, specifically,\n§§ 171.22, 171.23 and 171.24 authorize the use of the ICAD Technical Instructions\nfor the transportation of hazardous materials by aircraft. However, since the\nspecimens you describe are excepted from regulation under the HMR, use of the\n\"Exempt Human Specimen\" marking is neither required nor prohibited.\nIs it a violation of the HMR to label these shipments \"Exempt Human Specimen\"\nand claim the exception under § 173.134(b)(1l) when ordered by the parent\ncompany to ship these specimens to a clinical laboratory for routine testing?\nA2. The answer is no. See Answer AI.\nSincerely,\n~7~~~?f:::-\nT. Glenn Foster\nChief, Regulatory Review and Reinvention Branch\nStandards and Rulemaking Division\n2\n\n<<<PAGE 3>>>\n\nE.olm OVl 60 Yj\n~ /t13~ 13Lj\n§ {7~. I Q'7 '\nR~tlIO!Y Medica I Waste\nB i0 S torage. 1I-031Y\nTECHNOLOGIES\n19 December 2011\nOffice of Hazardous Materials Standards\nPipeline and Hazardous Materials Safety Administration\nAttn: PHH-lO\nU.S. Department of Transportation, East Building\n1200 New Jersey Avenue, SE.\nWashington, DC 20590-0001\nTo Whom It May Concern:\nI am writing to request written clarification regarding the following shipping situation:\nIn a clinical trial for the development of diagnostic testing for the detection of Colon Cancer or\npre-cancerous cells from a stool sample, fecal material is collected from human subjects in their\nresidence and shipped to the warehouse of the parent company conducting the clinical study.\nSpecimens collected from multiple patients are held until a sufficient amount of specimens are\npresent and are then shipped via bulk packaging on dry ice to a third party warehouse for long\nterm storage at ultra-cold temperatures of -800 Celsius. Prior to shipping to the third party\nwarehouse, the specimens are not routinely tested for the presence of an infectious substance.\nThese samples are considered liquid, but in a frozen state.\nAt a future date, the parent company will request that these specimens be shipped from the\nthird party warehouse to a clinical laboratory for routing testing. At the time of shipping to the\nclinical laboratory, it is not known to the third party warehouse if that routine testing is related\nto the diagnosis of an infectious disease.\nEmployees at the company conducting the clinical studYI in charge of determining the hazard\nclass of these specimens are considered hazmat employeesl as defined in ~171.8, who have\nbeen trained and tested by their hazmat employers in accordance with Subpart H of Part 172.\nBioStorage Technologies 2910 Fortune Circle West Drive, STE E Indianapolis, IN 46241 USA\n\n<<<PAGE 4>>>\n\nThese employees have determined that the proper classification of \"Exempt Human Specimen\"\napplies for all transportation throughout the clinical study.\nQ 1: Do batched shipments containing numerous different patient's specimens, having been\nclassified by trained personnel as \"Exempt Human Specimen\" and being shipped in bulk\npackaging from the parent company to a third party warehouse for long-term ultra-cold storage\nqualify for exemption from the HMR under 173.134(b) (11)7\nQ 2: When ordered by the parent company to ship these specimens to a clinical laboratory for\nroutine testing as part of the clinical study, is it in violation of the HMR to label these shipments\nas \"Exempt Human Specimen\" and claim exemption from the HMR under 173.134 (b) (11)?\nThank you for the opportunity to submit this request for interpretation and I look forward to\nyour response. I may be reached at 317-452-4820 for further clarification, if needed.\nRegards,\nDarcy Britt\nGlobal Logistics Compliance Supervisor\nBioStorage Technologies\nTECHNOLOGIES\n BioStorage.\nDarcy Britt, CHB, CCS\nGlobal Logistics\nCompliance Supervisor\nW: +13173901866\nM: +1317 2245478\ndarcy.britt@biostorage.com\n2910 Fortune Orcle W • Suite E • Indianapolis, IN 46241\nwww.biostorage.com\nBioStorage Technologies 2910 Fortune Circle West Drive, STE E Indianapolis, IN 46241 USA","truncated":false,"body_characters":6730}