LMC Pathology Services — Hazardous Materials Safety Interpretation

Page 1of Transportation U.S. Department MAR 9 2007 Washington, D.C. 20590 400 Seventh Street, S.W. Pipeline and Administration Hazardous Materials Safety Ms. Jane Swerdlow Chief Operating Officer Ref. No. 07-0025 LMC Pathology Services 3059 S. Maryland Parkway, #100 Las Vegas, NV 89109-2201 Dear Ms. Swerdlow: This responds to your letter concerning transportation of blood and body fluids under the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180). Specifically, you ask whether blood, body fluids, and similar specimens are subject to regulation as Category B, Division 6.2 materials. In accordance with § 173.134(b)(11), a human or animal sample being transported for routine testing not related to the diagnosis of an infectious disease and for which there is a low probability that the sample is infectious is not subject to regulation under the HMR. There is no requirement that samples transported in accordance with this section must be transported in exclusive-use vehicles. Note, however, that formalin (10% formaldehyde solution) is a Class 9 material and is subject to regulation for transportation by air. For ground transportation, neither the samples nor the formalin (10% formaldehyde solution) are regulated under the HMR. I hope this information is helpful. Please contact this office if you have additional questions. Sincerely, With is Hattie L. Mitchell Office of Hazardous Materials Standards Chief, Regulatory Review and Reinvention 173.134(6X11) 070025#

Page 2McIntyre $113-1346 11) LMO Definitions /Exceptions PATHOLOGY SERVICES 07-0025 U.S. Department of Transportation Pipeline and Hazardous Materials Safety Administration 400 7' St. S.W. Office of Hazardous Materials Safety Washington DC, 20590 Re: Request of Interpretation I am the Chief Operating Officer of a small anatomic pathology based laboratory. Our laboratory couriers pick up and deliver medical specimens including tissue samples in 10% formalin, blood collected in vaccutainer-type tubes, body fluids as well as specimens for culture all for diagnostic testing. These specimens are from hospitals, surgery centers, physician offices and clinics. All specimens are triple packaged and currently transported in personal vehicles not used exclusively for this purpose. We are requesting an interpretation regarding the regulations for exceptions o: Division 6.2, Category B materials under 49 CFR Section 173.134 Class 6, Division 6.2- Definitions and exceptions. In reviewing the exceptions under Section 173.174 (b), do these type of specimens meet the criteria for exception for Division of 6.2 materials under (11)? If we meet this exception, is it also necessary to transport these specimens in vehicles used exclusively for transport of such materials as defined in (10) of the same section? As an organization we want to make sure that we are in compliance with all of these regulations. If you have any questions, my direct telephone number is 702-938-9904 or my e-mail address is Swerdlow@lmclabs.com. Thank you for your assistance. Sincerely, Jane Swerdlow Chief Operating Officer#