BioStorage Technologies — Hazardous Materials Safety Interpretation

Page 1U.S. Department 1200 New Jersey Avenue SE of Transportation Washington. DC 20590 Pipeline and Hazardous Materials Safety Administration Ms. Darcy Britt Global Logistics Compliance Supervisor BioStorage Technologies 2910 Fortune Circle West Drive, Suite E Indianapolis, IN 46241 Reference No. 11-0314 Dear Ms. Britt: This is in response to your December 19, 2011 letter requesting clarification of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to human specimens collected from multiple patients at their residences as part of a clinical trial to develop diagnostic tests for detecting colon cancer or pre-cancerous cells. Specifically, you state when a sufficient number of the samples have been collected, the parent company conducting the study ships them in bulk packages on dry ice to a thirdparty warehouse where they are held for long-term storage at -80°C. You also state at a future date these samples will be shipped from the third-party warehouse to a clinical laboratory for routine testing, but at no point will they be tested to determine their hazard class - so it is unknown. In addition, you state the parent company employees are hazmat trained in accordance with 49 CFR Part 172, Subparts H (training) and I (security), and have determined the proper classification of the specimens is "Exempt Human Specimen," a designation authorized under Section 6.3.2.3.6 of the International Civil Aviation Organization (leAO) Technical Instructions for the Safe Transportation of Dangerous Goods by Air (Technical Instructions). We have paraphrased your questions and answered them in the order you provided. Q1. Do batched shipments of numerous, different patient specimens classed by trained personnel as "Exempt Human Specimen," and shipped in bulk packages from a parent company to a third-party warehouse for long-term, ultra-cold storage qualify as excepted from regulation under the HMR in conformance with § 173.134(b)(1l)? AI. The answer is yes. Under § 173.134(b)(1l), 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. For your information, please note that "Exempt Human Specimen" is not a hazard class or wording that appears in the HMR. It is a#

Page 202. marking required under Part 2, Chapter 6, § 6.3.2.3.6 of the ICAD Technical Instructions for patient specimens for which professional judgment has been used to determine that there is minimal likelihood pathogens are present, and the specimens are packaged in conformance with that section and offered or intended for transportation by aircraft. 49 CFR Part 171, Subpart C, and, specifically, §§ 171.22, 171.23 and 171.24 authorize the use of the ICAD Technical Instructions for the transportation of hazardous materials by aircraft. However, since the specimens you describe are excepted from regulation under the HMR, use of the "Exempt Human Specimen" marking is neither required nor prohibited. Is it a violation of the HMR to label these shipments "Exempt Human Specimen" and claim the exception under § 173.134(b)(1l) when ordered by the parent company to ship these specimens to a clinical laboratory for routine testing? A2. The answer is no. See Answer AI. Sincerely, ~7~~~?f:::- T. Glenn Foster Chief, Regulatory Review and Reinvention Branch Standards and Rulemaking Division 2#

Page 3E.olm OVl 60 Yj ~ /t13~ 13Lj § {7~. I Q'7 ' R~tlIO!Y Medica I Waste B i0 S torage. 1I-031Y TECHNOLOGIES 19 December 2011 Office of Hazardous Materials Standards Pipeline and Hazardous Materials Safety Administration Attn: PHH-lO U.S. Department of Transportation, East Building 1200 New Jersey Avenue, SE. Washington, DC 20590-0001 To Whom It May Concern: I am writing to request written clarification regarding the following shipping situation: In a clinical trial for the development of diagnostic testing for the detection of Colon Cancer or pre-cancerous cells from a stool sample, fecal material is collected from human subjects in their residence and shipped to the warehouse of the parent company conducting the clinical study. Specimens collected from multiple patients are held until a sufficient amount of specimens are present and are then shipped via bulk packaging on dry ice to a third party warehouse for long term storage at ultra-cold temperatures of -800 Celsius. Prior to shipping to the third party warehouse, the specimens are not routinely tested for the presence of an infectious substance. These samples are considered liquid, but in a frozen state. At a future date, the parent company will request that these specimens be shipped from the third party warehouse to a clinical laboratory for routing testing. At the time of shipping to the clinical laboratory, it is not known to the third party warehouse if that routine testing is related to the diagnosis of an infectious disease. Employees at the company conducting the clinical studYI in charge of determining the hazard class of these specimens are considered hazmat employeesl as defined in ~171.8, who have been trained and tested by their hazmat employers in accordance with Subpart H of Part 172. BioStorage Technologies 2910 Fortune Circle West Drive, STE E Indianapolis, IN 46241 USA#

Page 4These employees have determined that the proper classification of "Exempt Human Specimen" applies for all transportation throughout the clinical study. Q 1: Do batched shipments containing numerous different patient's specimens, having been classified by trained personnel as "Exempt Human Specimen" and being shipped in bulk packaging from the parent company to a third party warehouse for long-term ultra-cold storage qualify for exemption from the HMR under 173.134(b) (11)7 Q 2: When ordered by the parent company to ship these specimens to a clinical laboratory for routine testing as part of the clinical study, is it in violation of the HMR to label these shipments as "Exempt Human Specimen" and claim exemption from the HMR under 173.134 (b) (11)? Thank you for the opportunity to submit this request for interpretation and I look forward to your response. I may be reached at 317-452-4820 for further clarification, if needed. Regards, Darcy Britt Global Logistics Compliance Supervisor BioStorage Technologies TECHNOLOGIES BioStorage. Darcy Britt, CHB, CCS Global Logistics Compliance Supervisor W: +13173901866 M: +1317 2245478 darcy.britt@biostorage.com 2910 Fortune Orcle W • Suite E • Indianapolis, IN 46241 www.biostorage.com BioStorage Technologies 2910 Fortune Circle West Drive, STE E Indianapolis, IN 46241 USA#