University of California, Irvine — Hazardous Materials Safety Interpretation

Page 1of Transportation U.S. Department 400 Seventh St., S.W. Research and Washington, D.C. 20590 Administration Special Programs MMAR 99 28064 University of California, Irvine Mr. Chris Younghans-Haug Ref. No. 04-0034 4600 Bison Avenue Irvine, CA 92697-2725 Dear Mr. Younghans-Haug: This is in response to your letter asking whether human cells and human cell lines are regulated under the Hazardous Materials Regulations (HMR; 49 CFR, Parts 171-180), the International Civil Aviation Association (ICAO) Technical and the International Air Transport Association (IATA) Instructions for the Safe Transport of Dangerous Goods by Aix, Dangerous Goods Regulations. being transported for research purposes and do not contain You state that the materials are pathogens. marking of packages and use of a shipper's declaration if these You also ask for clarification regarding the materials are not subject to the regulations. with certain exceptions The HMR authorizes the use of the ICAO Technical Instructions. not authorize the use of the IATA Dangerous Goods Regulations. as an alternative to the HMR, but does Regulations, we suggest you contact the organization at For questions regarding the use of the IATA Dangerous Goods 514/390-6770. Human cells and human cell lines definition of Division 6.2 materials are not regulated under that do not meet the the HMR or the ICAO Technical Instructions unless the materials meet the definition of another hazard class or are contained in regulations, such as formalin packages with other materials that are (Class subject to the (Class 9). 3) or carbon dioxide a proper shipping name, UN number and hazard class to be marked You also ask whether these materials, if non-regulated, require declaration on packages and whether such materials require a shipper's stating that the materials are hazardous. Packages 040034 1111.2#

Page 2containing materials that are not subject to the regulations may not be marked, certified, or otherwise represented as a hazardous material when (see § 171.2 (£) (2)) . a hazardous material is not present if you have additional questions. I hope this information is helpful. Please contact this office Sincerely, Hotter mithel Hattie I. Mitchell, Chief Regulatory Review and Reinvention office of Hazardous Materials Standards#

Page 3UNIVERSITY OF CALIFORNIA, IRVINE BERKELBY • DAVIS • IRVINE • LOS ANGELES • MERCED • RIVERSIDE • SAN DIEGO • SAN FRANCISCO SANTA BARBARA • SANTA CRUZ Mature 4600 BISON AVE. ENVIRONMENTAL HEALTH AND SAFETY §173.134 FAX NUMBER: (949) 824-8539 IRVINE, CALIFORNIA 92697-2725 Applicability, February 9, 2004 Director Ed Mazzullo Department of Trausportatior Definition Routing Attr: DHM-10 fice of Hazardous Materials Safet 04-0034 10 Seventh Street, S ashington DC, 205! Subject: Request for formal Letter of Interpretation Dear Director Mazzullo: Specimens—are regulated under the Hazardous Materials Regulations including those of ICAO and IATA. I would like to know whether human cells and human cell lines commonly used in medical research—not Diagnostic Universal Precautions, Standard Precautions, and those described in Appendix H While we handle human cells and human cell lines in our rescarch labs according to the safety principles and practices of (http://www.cdc.gov/od/ohs/biosfty/bmbl4/b4ah.htm) of Center for Disease Control's Biosafety for Medical and Biomedical Laboratories, 4" Edition, the cells are not known to contain pathogens or cause harm to the environment. The amount of sample per primary container that I would anticipate that a rescarcher might ship to colleagues at other research ten (10) milliliters. institutions ranges from less one (1) milliliter up to one hundred (100) milliliters. Generally, sample size would be less than fiberboard outer packaging. Our packaging consists of watertight primary container, absorbent padding, watertight secondary container, and then If human cells and human cell lines for research purposes—not Diagnostic Specimens-and not known to contain pathogens proper markings of the outer package would not require an UN number, proper shipping name, or class. Nor would the or harm the environment are not regulated by the Hazardous Materials Regulations including those of ICAO and IATA, then shipper need to complete the Shipper's Declaration to declare the goods as dangerous. Your office's formal Letter of Interpretation will allow us to provide accurate shipping guidance to our medical researchers. Cordiall Chris Younghans-Haug Chemical Safety Programs Specialist#