{"operation":"document","citation":"06-0181","title":"Laboratory Medicine Consultants — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2006-08-22","effective_on":null,"summary":"06-0181 response to Laboratory Medicine Consultants concerning 173.134, 173.6.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-06-0181.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-06-0181.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-06-0181","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2006/060181.pdf","body":"<<<PAGE 1>>>\n\nJ.S. Department\nof Transportatior\nWashington, D.C. 20590\n400 Seventh Street, S.W.\nPipeline and\nAdministration\nHazardous Materials Safety\nAUG 22 2006\nMs. Jane Swerdlow\nRef. No.: 06-0181\nLaboratory Medicine Consultants\nChief Operating Officer\n3059 South Maryland Parkway\nLas Vegas, NV 89109-6209\nDear Ms. Swerdlow:\nThis is in response to your July 28, 2006 letter, requesting clarification of the diagnostic\nspecimen requirements in the Hazardous Materials Regulations (HMR; 49 CFR Parts\nexception in § 173.6 to pick up and deliver diagnostic specimens (e.g., biopsies in 10%\n171-180). Specifically, you ask if your couriers may use the Materials of Trade (MOTS)\nformalin, pap smears, and body fluids) for testing.\nUnder current HMR requirements, the MOTS exception may be used to transport\nbiological product, or regulated medical waste. A diagnostic specimen is any human or\nDivision 6.2 material, other than a Risk Group 4 material, that is a diagnostic specimen,\nanimal material, including excreta, secreta, blood and its components, tissue, and tissue\ninfected humans or animals. Provided the biopsies, pap smears, and body flu ds are\nfluids being transported for diagnostic or investigational purposes, but excluding live\nbeing transported by your employees in support of your business and do not contain a\nRisk Group 4 infectious substance you may take full advantage of the MOTS exception.\nIn addition to the MOTS exception, you may also utilize the exception in § 173.134(b)(6)\nto transport diagnostic specimens. In accordance with this paragraph, diagnostic\nspecimens are excepted from all requirements in the HMR provided they are transported\nby private or contract carrier in a motor vehicle used exclusively to transport diagnostic\nspecimens or biological products.\nOn June 2, 2006 we published a final rule under Docket HM-226A (71 FR 32244)\nentitled, \"Hazardous Materials: Infectious Substances; Harmonization with the United\nNations Recommendations.\" The rule, which becomes effective on October 1, 2006, will\nalign the HMR with international regulations applicable to the transportation of Division\n6.2 materials. The most significant change is the adoption of a two-tiered classification\nsystem for Division 6.2 materials comprised of Category A and Category B materials in\nplace of the current four-tiered risk group system. The final rule will not charge the\napplicability of the MOTS or private/contract carrier exceptions to your operation.\n173.6\n173.134(616)\n060181\n\n<<<PAGE 2>>>\n\nHowever, we suggest you review the changes prior to October 1, 2006. The final rule is\navailable at the following URL:\nhttp://hazmat.dot.gov/regs/rules/final/71fr/docs/71fr-32243.pdf\nI hope this information is helpful. Please contact us if you require additional assistance.\nSincerely,\n7.i\nJohn À. Gale\ni Office of Hazardous Materials Standards\nChief, Standards Development\n\n<<<PAGE 3>>>\n\nSupko\n§113.13466)6)\nJuly 28, 2006\n5,\n173-6\nU.S. Department of Transportation\nDefinitions \"Exceptions\nPipeline and Hazardous Materials Safety Administration\n06-0181\n400 7\" St., S.W.-\nOffice Of Hazardous Materials Safety\nWashington, DC 20590\nRe: Request for Interpretation\nI am requesting an interpretation regarding the regulations governing ground\ntransportation of medical laboratory specimens. Our laboratory couriers pick up and\ndeliver medical specimens, primarily biopsies in 10% buffered formalin, pap smears and\nbody fluids, for diagnostic testing. It is our understanding these specimens meet the\ndefinition of a diagnostic specimen as described in CFR49 173.134 Class 6, Division 6.2\n(4) and are an exception from Division 6.2. Therefore these specimens do not need an\nUN identification number. They are packaged for shipment according to CFR 173.6 (4).\nAs an organization we want to make sure our interpretation is correct and they we do not\nneed any separate DOT designation for transportation of these specimens.\nIf you have any questions, my direct telephone number is 702-938-9904 or my e-mail\naddress is swerdlow @Imclabs.com. Thank you for your assistance.\nSincerely,\nJane Swerdlow\nChief Operating Officer\nLaboratory Medicine Consultants","truncated":false,"body_characters":4158}