Quest Diagnostics — Hazardous Materials Safety Interpretation

Page 1Washington, D.C. 20590 400 Seventh Street, S.W. Pipeline and Administration Hazardous Materials Safety JUL 31 2006 Mr. Nicholas Pagerly Reference No. 06-0094 Manager, Specimen Packaging Flight Operations Safety Officer 159 Museum Road Quest Diagnostics Reading, PA 19605 Dear Mr. Pagerly: specimens offered for transport by aircraft under the International Civil Aviation This is in response to your April 18, 2006 letter concerning how to classify patient needed to determine if there is a "minimal likelihood" a patient specimen is an infectious bstance (Division 6.2). You ask whether your medical experts can assess, based on t pes of tests your laboratories perform, if there is a "minimal likelihood" a patiel specimen contains a Biological substance, Category A or Category B, or an Exempt human specimen. The answer is yes. While some tests for the presence of an infectious agent may be in the absence of specific information may use the types of tests requested by a medical requested for patient samples as a routine healthcare practice, a receiver of such a sample judgment of the patient's condition. We have based this opinion on the determination by health care specialists and scientist at the World Health Organization and the U.S. from samples taken from apparently healthy patients and animals and transported for Department of Health and Human Services that the risk of infection during transportation 171.11 173.134 060094#

Page 2routine testing is extremely small. Conversely, if a human or animal sample is transported for other than routine testing when the testing is related to the diagnosis of an infectious disease and if there is reason to suspect that the sample is infectious, that sample is subject to the HIMR. I hope this information is helpful. Sincerely, Hattie L. Mitchell, Chief Office of Hazardous Materials Standards Regulatory Review and Reinvention#

Page 36103100389 QUESI DIAGNUSIICS 04:04:18 p.m 04-18-2006 212 Edmonson 313.134 Quest Definitions Exceptions Diagnostics 06-0094 April 18, 2006 Nicholas Pagerly, Flight Operations Safety Officer, 159 Museum Road Manager, Specimen Packaging Reading, PA 19605 (800) 694-1247 Toll Free (610) 376-6389 Fax nicholas.a.pagerly@questdiagnostics.com Dear Sirs, Quest Diagnostics is considering the feasibility of applying the procedures outlined in the ICAO Technical Instructions as they pertain to the transport: of infectious specimens pursuant to CFR 49 171.11. Accordingly, Quest Diagnostics is currently examining the possibility of making changes to the way in which it presently classifies patient specimens for transport. During this examination a question has arisen regarding the definition of the term "minimal likelihood". determination of 'minimal likelihood" is dependant upon a "professional opinion" In the ICAO Guidance Document it states that the local conditions to name but a few. which is based upon the patient's medical record, exhibited symptoms and endemic As a medical testing facility, we would not necessarily have this specific information transport. What we do know is what test the patient's physician has ordered. As when a patient specimen is received at the laboratory to be packaged for further such, it is our opinion that by having our medical experts examine each of the test types that Quest Diagnostics currently offers; and by building a list of which tests should be classified as Category A, Biological Substance, Category B, and Exempt Human Specimen, this would then constitute a "professional opinion" and thereby "minimal likelihood" of harboring a potentially harmful pathogen. comply with the regulatory requirement to determine that a patient specimen has a on the validity of our due diligence. Quest Diagnostics is requesting that the DOT consider our example and comment Sincerely, Nicholas Pagerly#