Regulatory Resources, Inc. — Hazardous Materials Safety Interpretation

Page 1of Transportation U.S. Department Washington, D.C. 20590 400 Seventh Street, S.W. Pipeline and Hazardous Materials Safety Administration SEP 2 0 2006 Mr. Bruce McLees Ref. No.: 05-0278 Sr. Quality Engineer Quallion LLC 12744 San Fernando Road Sylmar Biomedical Park Sylmar, CA 91342-3728 Dear Mr. McLees: This is in response to your November 2, 2005 letter concerning requirements under the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) for design-type testing of lithium-ion batteries. Please accept my apology for our delay in responding and any inconvenience this may have caused. In your letter you specifically request clarification concerning the tests applicable for your prototype lithium-ion batteries and cells. You state that specific requirements you address are contained in Section 38.3.2.1 of the United Nations you have been working on a variety of battery packs with 5 to 120 cells in a battery pack. The Manual of Tests and Criteria and are implemented through the provisions of § 173.185 of the HMR. Your questions are paraphrased and answered below: Q1: Is testing of every lithium-ion battery pack configuration required or would the successful testing of the cells to the UN Manual of Tests and Criteria be sufficient? A1: the tests in the UN Manual of Tests and Criteria, even if the cells that make up the battery Except for single cell batteries, each new lithium cell and battery design type is subject to have been tested. A cell or battery is deemed to be "a new design type" if the change in mass to the cathode, anode or electrolyte is more than 0.1 grams or 20 percent, whichever is greater, or the change would materially affect the test results. Q2: Are there alternate shipping or packaging methods such as ground or special courier that Cour braised that wouid not require testing of each lithium-ion batery pack A2: The answer is no. There are no exceptions from the testing requirements in § 173.185(e) based on the mode of transportation or type of packaging used. Q3: May these prototype lithium-ion batteries be shipped by ground transportation as Class 9 for testing purposes under § 173.185(j) of the HMR? 173.185 050278#

Page 2A3: The answer is no. According to your letter your batteries are not being stipped for testing purposes and therefore the exception in § 173.185(j) does not apply. Currently, there are no applicable exceptions tor prototype lithium batteries and cells under the HMR similar to Special Provision 310 in the UN Recommendations. Cells and batteries the provisions in § 173.185 may be transported only if they are approved by the Associate and equipment containing or packed with cells and batteries which do not comply with I hope this information is helpful. Please contact us if you require additional assistance. Sincerely, •- John A. Gale ¿ Office of Hazardous Materials Standards Chief, Standards Development#

Page 311/03/2005 THU 10:06 FAX Pollack 40101 QUALLION® teler tort Sylrnar Biomedical Par 2744 San Fernando Road, Sylmar, CA 9134 § 13,185 www.quallion.com Phone (818) 933-2000 • Fax (818) 833-2001 Batteries November 2, 2005 05-0218 Mr. Edward T. Mazzullo Director, Office of Hazardous Materials Standards U.S. DOT/PHMSA (PHH-10) Washington, D.C. 20590-0001 400 7th Street S.W. Phone (800) 467-4922 fax (202) 366-3012 Re: Request for interpretation of DOT regulation 49 CFR 173.185. Dear Sir: unique hattery solutions for nur customer we tond to have a large variety of low volume cells and Quallion is a manufactwer of custom lithium ion batteries. Since our business is developing battery packs. Recently we have been working on a varicty of battery packs for cur customers with 5 to 120 cells in a pack. The total shipments for any onc pack configuration may be only the test sequence. This is a high percentage of our expected shipments and the cost may prevent 100 packs. The UN Manual of Tests and Crileria indicate that 24 packs would be necessary for us from participating in this market. The questions posed below will help us beller understand our options. UN Manual of Tests and Critcria be sufficient? Is testing of every pack configuration required or would the successful testing of the cells to the 2. be used that would not require the testing of cach pack configuration? Arc there allerate shipping or packaging methods such as ground or special courier that could 3. Iransportation as class 9 for testing purposes (173.185(i))? - Would these limited protocype production runs fall under the classification that allows for ground Your timely assistance in the matter is greatly appreciated. any questions. Please call, e-mail or fax if you have Bruce McLee (818) 833-2096 SI. Quality Engineer fax (818) 833-3279 brucem @quallion.com cc: Robert Licha#