{"operation":"document","citation":"04-0034","title":"University of California, Irvine — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2004-03-09","effective_on":null,"summary":"04-0034 response to University of California, Irvine concerning 171.2.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-04-0034.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-04-0034.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-04-0034","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2004/040034.pdf","body":"<<<PAGE 1>>>\n\nof Transportation\nU.S. Department\n400 Seventh St., S.W.\nResearch and\nWashington, D.C. 20590\nAdministration\nSpecial Programs\nMMAR 99 28064\nUniversity of California, Irvine\nMr. Chris Younghans-Haug\nRef. No. 04-0034\n4600 Bison Avenue\nIrvine, CA 92697-2725\nDear Mr. Younghans-Haug:\nThis is in response to your letter asking whether human cells\nand human cell lines are regulated under the Hazardous\nMaterials Regulations (HMR; 49 CFR, Parts 171-180), the\nInternational Civil Aviation Association (ICAO) Technical\nand the International Air Transport Association (IATA)\nInstructions for the\nSafe Transport of Dangerous Goods by Aix,\nDangerous Goods Regulations.\nbeing transported for research purposes and do not contain\nYou state that the materials are\npathogens.\nmarking of packages and use of a shipper's declaration if these\nYou also ask for clarification regarding the\nmaterials are not subject to the regulations.\nwith certain exceptions\nThe HMR authorizes the use of the ICAO Technical Instructions.\nnot authorize the use of the IATA Dangerous Goods Regulations.\nas an alternative to the HMR, but does\nRegulations, we suggest you contact the organization at\nFor questions regarding the use of the IATA Dangerous Goods\n514/390-6770.\nHuman cells and human cell lines\ndefinition of Division 6.2 materials are not regulated under\nthat do not meet the\nthe HMR or the ICAO Technical Instructions unless the materials\nmeet the definition of another hazard class or are contained in\nregulations, such as formalin\npackages with other materials that are\n(Class\nsubject to the\n(Class 9).\n3) or carbon dioxide\na proper shipping name, UN number and hazard class to be marked\nYou also ask whether these materials, if non-regulated, require\ndeclaration\non packages and whether such materials require a shipper's\nstating that the materials are hazardous.\nPackages\n040034\n1111.2\n\n<<<PAGE 2>>>\n\ncontaining materials that are not subject to the regulations\nmay not be marked, certified, or otherwise represented as a\nhazardous material when\n(see\n§ 171.2 (£) (2)) .\na hazardous material is not present\nif you have additional questions.\nI hope this information is helpful.\nPlease contact this office\nSincerely,\nHotter mithel\nHattie I. Mitchell, Chief\nRegulatory Review and Reinvention\noffice of Hazardous Materials Standards\n\n<<<PAGE 3>>>\n\nUNIVERSITY OF CALIFORNIA, IRVINE\nBERKELBY • DAVIS • IRVINE • LOS ANGELES • MERCED • RIVERSIDE • SAN DIEGO • SAN FRANCISCO\nSANTA BARBARA • SANTA CRUZ\nMature\n4600 BISON AVE.\nENVIRONMENTAL HEALTH AND SAFETY\n§173.134\nFAX NUMBER: (949) 824-8539\nIRVINE, CALIFORNIA 92697-2725\nApplicability,\nFebruary 9, 2004\nDirector Ed Mazzullo\nDepartment of Trausportatior\nDefinition\nRouting Attr: DHM-10\nfice of Hazardous Materials Safet\n04-0034\n10 Seventh Street, S\nashington DC, 205!\nSubject: Request for formal Letter of Interpretation\nDear Director Mazzullo:\nSpecimens—are regulated under the Hazardous Materials Regulations including those of ICAO and IATA.\nI would like to know whether human cells and human cell lines commonly used in medical research—not Diagnostic\nUniversal Precautions, Standard Precautions, and those described in Appendix H\nWhile we handle human cells and human cell lines in our rescarch labs according to the safety principles and practices of\n(http://www.cdc.gov/od/ohs/biosfty/bmbl4/b4ah.htm) of Center for Disease Control's Biosafety for Medical and Biomedical\nLaboratories, 4\" Edition, the cells are not known to contain pathogens or cause harm to the environment.\nThe amount of sample per primary container that I would anticipate that a rescarcher might ship to colleagues at other research\nten (10) milliliters.\ninstitutions ranges from less one (1) milliliter up to one hundred (100) milliliters. Generally, sample size would be less than\nfiberboard outer packaging.\nOur packaging consists of watertight primary container, absorbent padding, watertight secondary container, and then\nIf human cells and human cell lines for research purposes—not Diagnostic Specimens-and not known to contain pathogens\nproper markings of the outer package would not require an UN number, proper shipping name, or class. Nor would the\nor harm the environment are not regulated by the Hazardous Materials Regulations including those of ICAO and IATA, then\nshipper need to complete the Shipper's Declaration to declare the goods as dangerous.\nYour office's formal Letter of Interpretation will allow us to provide accurate shipping guidance to our medical researchers.\nCordiall\nChris Younghans-Haug\nChemical Safety Programs Specialist","truncated":false,"body_characters":4566}