{"operation":"document","citation":"11-0023","title":"BioStorage Technologies — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2011-04-08","effective_on":null,"summary":"11-0023 response to BioStorage Technologies concerning 173.134, 173.199.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-11-0023.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-11-0023.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-11-0023","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretations/2011/110023.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department of Transportation 1200 New Jersey Ave, SE\nAPR 072011 Washington, D.C. 20590\nPipeline and Hazardous Materials\nSafety Administration\nMs. Darcy Britt\nGlobal Logistics Compliance Supervisor\nBioStorage Technologies\n29lO Fortune Circle West Drive, Suite E\nIndianapolis, IN 46241\nReference No. 11-0023\nDear Ms. Britt:\nThis is in response to your February 3,2011 letter and February 22, 2011 telephone conversation\nwith a member of my staff requesting clarification of the Hazardous Materials Regulations\n(HMR; 49 CFR Parts 171-180) applicable to large numbers ofbatched patient specimen samples\nthat belong to other companies and for which the hazard class is unknown. Specifically, you\nstate your company places several hundreds of these samples inside low-temperature freezers\nthat it then places in exclusive-use, freight-container truck motor vehicles and transports from\none laboratory or long-term storage facility to one of your company's long-term storage\nfacilities.\nIn your letter, you state your company is describing the samples as \"UN 3373, Biological\nsubstances, Category B, 6.2 (infectious)\" as a precaution. You state most of the samples do not\ncontain additional material, but some may contain a fixed formalin solution as a preservative. In\nyour letter, you describe: (1) the primary packaging as a cryogenic vial that ranges in size from 2\nml to 12 ml; (2) the secondary packaging as a box that contains a sufficient amount of absorbent\nmaterial in its base to absorb the contents and a grid that holds one vial per compartment, the box\nis then closed and placed on a rack inside a Sanyo V.I.P. Series Ultra Low Freezer; and (3) the\nfreezer as the outer packaging. You also state the completed package is identical to those\nauthorized under DOT Special Permit DOT-SP 14969, and that your company's employees and\nauthorized agents prepare these packages for transport. You further state the freezers are loaded\nin a freight container, attached to and operated by a generator, and reach temperatures of -70°C,\n-80 °C, or -120°C. Finally, you state dry ice is sometimes transported on the vehicle as a\nprecautionary refrigeration method, the freight container and packagings are owned by your\ncompany, and the truck cabs are owned by Pace Air Freight, In~. You ask whether these samples\nas described above are excepted from regulation under § I 73. 134(b)(l 0) of the HMR.\nThe answer is no. Section 173.1 34(b)(10) excepts from regulation under the HMR patient\nsamples transported for research, diagnosis, investigational activities, or disease treatment or\nprevention. Samples transported solely for storage, as described in your letter, do not qualify for\nthis exception. In a final rule issued under Docket No. PHMSA-2004-16895 (HM-226A), this\n\n<<<PAGE 2>>>\n\nagency stated it permits unknown samples of infectious substances shipped for analysis and\ndiagnosis to be transported in accordance with requirements for Category B infectious\nsubstances, because historically, materials meeting this definition have been transported in a\nsimilar manner with no adverse safety impact or increased risk to transport workers or the\ngeneral public (6/2/2006; 71 FR 32244). Therefore, it is the opinion of this Division that patient\nspecimens shipped from a storage laboratory facility to another laboratory facility with no\nmedical knowledge of the patients from whom the specimens were obtained may be identified as\n\"UN 3373, Biological substances, Category B, 6.2.\" The specimens must be packaged in\nconformance with the requirements prescribed in § 173.199, and the proper shipping name\n\"Biological substances, Category B\" must be marked on the outside ofthe completed package\nalong with the \"UN 3373\" diamond-shaped mark in letters that are at least 6 mm (0.24 inches)\nhigh (see § 173.l99(a)(S)). For those situations where the identity of the agent or pathogen is not\nknown, but sufficient information is available to strongly suspect a Category A infectious\nsubstance, the HMR requires those materials to be shipped in accordance with all applicable\nhazard communication and packaging requirements for Category A infectious substances. The\nHMR also require that an indication that a sample contains a Category A infectious material be\nincluded on the shipping paper (see § 172.203(k)).\nRegarding DOT-SP 14969, please note that the packages authorized under this special permit\nmay only be used by the grantee, Pace Air Freight, Inc., and, when prepared by them, may be\ntransported by others provided the package is unchanged. The practices you describe are not in\nconformance with this special permit and may be in violation of the HMR. Your company may\nwish to apply for its own special permit to use this packaging. Ifso, the procedures for applying\nfor a special permit are prescribed in 49 CFR Part 107, Subpart B. Your application should be\ndirected to the Associate Administrator for Hazardous Materials Safety and should include\nspecific and detailed information concerning how you propose to package and transport the\nmaterials. You may also obtain this information from our website at\n''http://www.phmsa.dot.govlhazmat/regs/sp-a.''\nI hope this satisfies your request.\nSincerely,\nr-7rY~~~\nT. Glenn Foster\nChief, Regulatory Review and Reinvention Branch\nStandards and Rulemaking Division\n2\n\n<<<PAGE 3>>>\n\nBioStorage. TECHNOLOGIES\nFebruary 3, 2011\nU.S. DOT\nPHMSA Office of Hazardous Materials Standards\nAttn: PHH-10\nEast Building\n1200 New Jersey Avenue, SE.\nWashington, DC 20590-0001\nTo Whom It May Concern:\nI would like to ask you for further clarification of exemptions for packaging requirements for Division 6.2,\ncategory B Infectious Substances when transported inside of low temperature freezers within our\nexclusive use motor vehicle.\nPreface\nOur business offers long term storage and logistical solutions for their biological specimens. One of our\ncore solutions is the use of a state of the art semi trailer, designed to hold and maintain multiple\ntemperature range freezers, to insure sample integrity during large batched sample relocations. This\nmotor vehicle carries only medical, clinical or laboratory equipment or products.\nThese batched shipments contain numerous different patient specimens shipped from one storage facility\nto another storage facility with no knowledge of the patients from whom the specimens were obtained.\nDuring these batched shipments, patient specimens are placed in primary receptacles in such a way that,\nunder normal conditions of transport, they cannot break, be punctured, or leak their contents. Once\nsecure in the primary receptacles, the specimens are placed in secondary packaging, and then loaded\nonto the freezer shelves.\nOnce the freezer loading is complete, the freezer is locked and secured inside the trailer so that there is\nno release of hazardous material under conditions normally encountered in transportation.\nContinued on Next Page\n2910 Fortune Circle West Drive\nSuite E\nIndianapolis. Indiana 46241\n\n<<<PAGE 4>>>\n\nInterpretation Request\nOur relocation specialists are trained on the packaging requirements of 173.199 for Category B Infectious\nSubstance, and adhere to these regulations in all Situations, however, there is some question regarding\nthe eligibility of our freezers as the required rigid outer packaging under 49 CFR 173.199(a) (4).\n1. 2. If samples are classified as Division 6.2 materials, Category B infectious substances and\ntransported in our exclusive use, privately operated motor vehicle, do these qualify under 49 CFR\n173.134(b) (10) as exempted from the packaging requirements for Category B infectious\nsubstances?\nIf exempt, are we correct to interpret 49 CFR 173.134(b) (10) in such a way that packaging\nrequirements in 49 CFR 173.199 do not apply and our freezers will be acceptable as outer ridged\npackaging for transportation purposes?\nThank you for the opportunity to submit this request for interpretation.\nI look forward to your response. Should there be any additional questions regarding this question, please\ndo not hesitate to contact me at 317-452-4820.\nSincerely,\nDarcy Britt\nGlobal LogistiCS Compliance Supervisor\nBioStorage Technologies\n2910 Fortune Circle West Drive\nSuite E\nIndianapoliS, Indiana 46241\n2910 Fortune Circle West Drive\nSuite E\nIndianapolis,lndiana 46241","truncated":false,"body_characters":8314}