SeraCare Life Sciences — Hazardous Materials Safety Interpretation

Page 11 200 New Jersey Ave, SE U.S. Department of Transportation Washington, D.C. 20590 Pipeline and Hazardous Materials Safety Administration FED 3 2010 Mr. Colin Leavitt Jr. SeraCare Life Sciences 25 Birch Street Milford, MA 01757 Ref. No. 09-0299 Dear Mr. Leavitt Jr., This responds to your December 8, 2009 email regarding the transportation of small quantities under the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180). Specifically, you ask whether materials transported by your company may be shipped as excepted quantities and you request clarification of closure requirements for inner packagings used for excepted quantities. In your letter, you state that your company produces biological panels containing 4 ml capacity vials filled with a mixture of methanol (2.4 ml) and human blood and that you plan to ship the material by air. You ask whether you may ship this mixture of material as excepted quantities. Additionally, with regard to closure requirements for inner packagings, you ask whether a screw cap with an o-ring seal conforms to the requirements to use a positive means of closure for inner packagings. Assuming the mixture meets the definition of a Class 3 flammable liquid material and the human blood does not meet the definition of a Division 6.2 infectious substance, you are correct that your company may elect to transport the material by air using the exceptions for excepted quantities provided in § 173.4a. Regarding the closure requirements for inner packagings, a screw cap with an o-ring seal does not provide a positive means to ensure that the screw cap will be held in place. In accordance with § 173.4a(e)(2), a removable closure must be held securely in place with wire, tape, or other positive means (e.g., shrink-wrap). Note that the International Air Transport Association's standards do not have official standing under the HMR. When transporting hazardous material by air, you must transport in accordance with the HMR or alternative regulations authorized for use by the HMR in § 171.22 such as the#

Page 2International Civil Aviation Organization's Technical Instructions for the Safe Transport of Dangerous Goods by Air. I hope this infonnation is helpful. If you have further questions, please contact this Office. SinC:I~~ harles E. Betts hief, Standards Development o e..-ofHazardous Materials Standards#

Page 3Drakeford, Carolyn (PHMSA) From: INFOCNTR (PHMSA) Sent: Tuesday, December 08, 2009 11 :55 AM To: Drakeford, Carolyn (PHMSA) Subject: FW: Requesting clarification Sec 2.7.5 packaging; Excepted Quantities Carolyn, This gentleman wants a letter of interpretation on the below topic. Thanks, Rob From: Leavitt, Colin [mailto:cleavitt@seracare.com] Sent: Tuesday, December 08, 2009 11:26 AM To: INFOCNTR (PHMSA) Subject: Requesting clarification Sec 2.7.5 packaging; Excepted Quantities Dear Sir or Madame, We have a project in development and our application is an OEM biological panel containing 4 vials at 4 mls each. Each vial would contain 2.4 ml of methanol (methyl alcohol) and the balance of each vial containing human derived blood. Packaged in "Nunc" panel container and shrink wrapped. 1) I believe we can ship as an "excepted quantity", correct? 2) If so, can you please provide assistance I clarification on lATA subsection 2.7.5.1 (a), reading in part; ... the closure of each inner packaging must be held securely in place with wire, tape or other positive means; any receptacle having a neck with molded screw threads must have a leak proof threaded type cap. The closure must be resistant to the contents. Would I does a screw cap wi o-ring seal constitute a "positive means of closure" for the individual vial(s)1 each inner packaging? We would ship domestically, by air, via Federal Express. Thank You in advance for your assistance in this matter. Colin Leavitt Jr. Sr. Manager, Materials Management SeraCare Life Sciences 25 Birch Street Milford, MA. 01757 Phone: (508)244-6436 Fax: «508) 244-6536 or (508) 478-1740 Cell: (508) 958-9401 \f!:!{V:!.s_eraCiM~,com 12/8/2009#