Laboratory Medicine Consultants — Hazardous Materials Safety Interpretation

Page 1J.S. Department of Transportatior Washington, D.C. 20590 400 Seventh Street, S.W. Pipeline and Administration Hazardous Materials Safety AUG 22 2006 Ms. Jane Swerdlow Ref. No.: 06-0181 Laboratory Medicine Consultants Chief Operating Officer 3059 South Maryland Parkway Las Vegas, NV 89109-6209 Dear Ms. Swerdlow: This is in response to your July 28, 2006 letter, requesting clarification of the diagnostic specimen requirements in the Hazardous Materials Regulations (HMR; 49 CFR Parts exception in § 173.6 to pick up and deliver diagnostic specimens (e.g., biopsies in 10% 171-180). Specifically, you ask if your couriers may use the Materials of Trade (MOTS) formalin, pap smears, and body fluids) for testing. Under current HMR requirements, the MOTS exception may be used to transport biological product, or regulated medical waste. A diagnostic specimen is any human or Division 6.2 material, other than a Risk Group 4 material, that is a diagnostic specimen, animal material, including excreta, secreta, blood and its components, tissue, and tissue infected humans or animals. Provided the biopsies, pap smears, and body flu ds are fluids being transported for diagnostic or investigational purposes, but excluding live being transported by your employees in support of your business and do not contain a Risk Group 4 infectious substance you may take full advantage of the MOTS exception. In addition to the MOTS exception, you may also utilize the exception in § 173.134(b)(6) to transport diagnostic specimens. In accordance with this paragraph, diagnostic specimens are excepted from all requirements in the HMR provided they are transported by private or contract carrier in a motor vehicle used exclusively to transport diagnostic specimens or biological products. On June 2, 2006 we published a final rule under Docket HM-226A (71 FR 32244) entitled, "Hazardous Materials: Infectious Substances; Harmonization with the United Nations Recommendations." The rule, which becomes effective on October 1, 2006, will align the HMR with international regulations applicable to the transportation of Division 6.2 materials. The most significant change is the adoption of a two-tiered classification system for Division 6.2 materials comprised of Category A and Category B materials in place of the current four-tiered risk group system. The final rule will not charge the applicability of the MOTS or private/contract carrier exceptions to your operation. 173.6 173.134(616) 060181#

Page 2However, we suggest you review the changes prior to October 1, 2006. The final rule is available at the following URL: http://hazmat.dot.gov/regs/rules/final/71fr/docs/71fr-32243.pdf I hope this information is helpful. Please contact us if you require additional assistance. Sincerely, 7.i John À. Gale i Office of Hazardous Materials Standards Chief, Standards Development#

Page 3Supko §113.13466)6) July 28, 2006 5, 173-6 U.S. Department of Transportation Definitions "Exceptions Pipeline and Hazardous Materials Safety Administration 06-0181 400 7" St., S.W.- Office Of Hazardous Materials Safety Washington, DC 20590 Re: Request for Interpretation I am requesting an interpretation regarding the regulations governing ground transportation of medical laboratory specimens. Our laboratory couriers pick up and deliver medical specimens, primarily biopsies in 10% buffered formalin, pap smears and body fluids, for diagnostic testing. It is our understanding these specimens meet the definition of a diagnostic specimen as described in CFR49 173.134 Class 6, Division 6.2 (4) and are an exception from Division 6.2. Therefore these specimens do not need an UN identification number. They are packaged for shipment according to CFR 173.6 (4). As an organization we want to make sure our interpretation is correct and they we do not need any separate DOT designation for transportation of these specimens. If you have any questions, my direct telephone number is 702-938-9904 or my e-mail address is swerdlow @Imclabs.com. Thank you for your assistance. Sincerely, Jane Swerdlow Chief Operating Officer Laboratory Medicine Consultants#