TSO3, Inc. — Hazardous Materials Safety Interpretation

Page 1U.S. Department of Transportation Pipeline and Hazardous Materials Safety Administration APR 26 2010 1200 New Jersey Ave, SE Washington, D.C. 20590 Mr. Jean~Martin Vallieres Mechanical Engineer TS03, Inc. 2505 A venue Dalton Quebec, Quebec, Canada, GIP 3S5 Ref. No. 10-0065 Dear Mr. Vallieres: This responds to your March 15, 2010 email regarding UN Specification packaging authorized under the Hazardous Materials Regulations (HMR; 49 CFR Parts 171 ~ 180). Specifically, you ask whether your company must submit packaging compatibility test results and obtain an approval from DOT to use a foreign manufactured UN Specification packaging authorized by Transport Canada's Transportation of Dangerous Goods (TDG) Regulations for the transportation of an aqueous solution of 50% hydrogen peroxide. You questions are paraphrased and answered as follows: Ql. Our company is not required to resubmit chemical compatibility test results for the packaging to Transport Canada because of the availability of test results generated by the company filling the bottles in the packaging for similar packaging. Do we have to submit chemical compatibility tests results to DOT in order to transport our product in the U.S.? A1. No. In accordance with § 173 .24( e), compatibility tests for packaging materials and contents are required for plastic packaging or receptacles used for Packing Group (PG) I materials. Aqueous solutions of50% hydrogen peroxide are assigned PG II. Thus, no compatibility testing is required. Note that the packaging must conform to the general compatibility requirements of § 173 .24( e). Q2. Is our company required to obtain approval for use ofthe packaging from DOT if the company is registered with and has an approval for use ofthe packaging from Transport Canada? A2. No. In accordance with § 173. 12(a)(2), a UN Specification packaging authorized by Transport Canada's TDG Regulations may be used to transport hazardous material to the United#

Page 2States subject to the limitations of §§ 171.12, 171.22, and 171.23 and provided the packaging is equivalent to the UN Specification authorized by the HMR. See § 173.24(d)(2). I hope this information is helpful. If you have further questions, please contact this office. Sil'~ Charles E. Betts . ,Standards Development Office of Hazardous Materials Standards#

Page 3Drakeford. Carolyn (PHMSA) From: INFOCNTR (PHMSA) Packets I f)4_ Sent: Monday, March 15,20102:26 PM To: Drakeford, Carolyn (PHMSA) (0 --00 Ii5 Subject: FW: Questions regarding UN packaging in Forein country From: Jean-Martin Vallieres [mailto:jmvallieres@ts03.com] Sent: Monday, March 15, 2010 12:05 PM To: INFOCNTR (PHMSA) Subject: Questions regarding UN packaging in Forein country Hello, TS03, a company based in Canada, is now in a process to get transport approval for the shipment of a box with 4 bottles of hydrogen peroxide 50%. All the files/documentation has been submitted to Transport Canada in order to obtain the UN certification of the packaging and a certificate of registration that include the incorporation certificate of our company and a declaration of chemical compatibility testing as per CAN/CGSB.43-150-97 section 6.1 (equivalent of 49CFR173.24 (e». We have two questions for the DOT: 1­ In Canada, we don't have to resubmit the chemical compatibility test as per CAN/CGSB.43-150-97 section 6.1 because TS03 is using the same resin/liner than a well know chemical company in charge of filling TS03 bottle (Fisher Scientific item number H341-500). Do we have to submit test results to the DOT in order to ship the product in US? 2­ Do we have a register our company or obtain a certificate from the DOT before sh~ping the packaging in US if we have: 1 sl a UN certificate of our packaging emitted by Transport Canada and 2n a certificate of registration emitted by Transport Canada? Do you need of copy of documents emitted by Transport Canada? Please answer by email for traceability purposes Ref: http://www.fishersci.com/wps/portal/PRODUCTDET AIL ?prodcutdetail='prod'&productld=683664&catalogld=291 04&match edCatNo=H341500&pos=1 &catCode=RE SC&endecaSearchQuery=%23store%3DScientific%23N%3DO%23rpp%3D15& fromCat=yes&keepSessionSearchOutPut=true&fromSearch=Y&searchKey=h341 &highlightProductsltemsFlag=Y Best regards, Jean-Martin Vallieres, Eng. Mechanical Engineer, R&D 418651-0003/251 jmvallieres@ts03,com TS03 STERIZONE® Sterilization System Creating the Improved Standard in Healthcare Sterilization 2505. avenue Dalton, Quebec (Quebec) G1 P 3S5 CANADA Customer Service: 866715-0003 Technical Service: 888651-8763 T 418 651-0003 F 418 653-5726 www.ts03.com/Ticker Symbol: TOS on the TSX CONFIDENTIALITY NOTE: This document contains information from the offices of TS03 Inc. That information is confidential, and/or legally privileged and is intended only for the use of the named recipient(s), If you are not the intended recipient, you are hereby notified that any disclosure, copying, distribution or the taking of any action in reliance on the contents of this report information is strictly prohibited and that the document should be returned to this company immediately. If you have in fact receive this report in error, please notify us by telephone at 418651-0003 immediately so that we may correct the situation. Thank you, TS03 and STERIZONE® are registered trademark ofTS03 Inc. 1#