Philips Respironics — Hazardous Materials Safety Interpretation

Page 1U.S. Department of Transportation Pipeline and Hazardous Materials Safety Administration 1200 New Jersey Avenue, SE Washington, D.C. 20590 NOV 1 3 2012 Mr. Joseph E. Olsavsky Philips Respironics 1740 Golden Mile Highway Monroeville, PA 15146 Ref. No.: 12-0195 Dear Mr. Olsavsky: This responds to your September 4, 2012letter requesting clarification of the Hazardous Materials Regulations (HMR; 49 CPR Parts 171-180) applicable to your portable oxygen concentrator (POC) and its lithium ion battery pack. You reference an enclosed letter of interpretation issued by the Pipeline and Hazardous Materials Safety Administration (PHMSA) on December 22,2011 (Ref. No.: 11-0285) to your company, which states that your SimplyGo POC was not subject to the HMR provided it met the criteria of the interpretation letter. Now, you are investigating an engineering proposal to alter the lithium ion battery pack of your SimplyGo POC device "from 7.92 grams total lithium content (93 watt-hour pack) to 10.8 grams total lithium content (127 watt-hour pack)." Your questions are paraphrased and answered below. Q1: You ask whether the revised 10.8 grams total lithium content (127 watt-hour) pack would require Class 9 markings, labeling, specification packaging, and shipping papers under the HMR? A1: The 10.8 grams total lithium content (127 watt-hour) pack would be fully regulated under the HMR as a Class 9 hazardous material when transport is by aircraft or vessel but not when transport is by motor vehicle or rail. A device containing not more than 25 grams total lithium content per battery may be excepted from Class 9 requirements under§ 172.102(c)(1) Special provision 189 when transport is by motor vehicle or rail. However, due to the change from 7.92 grams total lithium content to 10.8 grams total lithium content, the device no longer qualifies under the§ 172.102(c)(1) Special provision 188 and would be regulated under§ 173.185. Provided in§ 173.185(c), lithium cells or batteries contained in equipment may be transported as Class 9 materials if the cells and batteries meet all the requirements of paragraph§ 173.185(a), except paragraph (a)( 4), and the equipment is packed in a strong outer packaging. The equipment and cells or batteries must be secured within the outer packaging and be packed so as to prevent movement, short circuits, and#

Page 202: A2: accidental operation during transport. Furthermore, the Class 9 markings, labeling, and shipping paper provisions would be required. You ask what ramifications (i.e., the revised 10.8 grams total lithium content (127 watt-hour pack)) would this have on airline travel, i.e. SPAR 106? As you may know, Special Federal Aviation Regulation 106 (SFAR 106) "Rules for Use of Portable Oxygen Concentrator Systems on Board Aircraft" is under the purview of the Federal Aviation Administration (FAA), not PHMSA. However, in order for the device to qualify as a POC device under SPAR 106 it must not contain hazardous materials as determined by PHMSA (See section 2 of 14 CFR Part 121, SFAR 106). As a matter of policy, a lithium battery installed within a POC device must conform to § 172.102( c )(1) Special provision 188 in order to be considered an eligible device under SFAR 106. As indicated in Al above, a lithium ion battery pack with 10.8 grams total lithium content does not qualify under SP 188 and would invalidate your existing FAA approval under SF AR 106. I hope this satisfies your inquiry. Please contact us if we can be of further assistance. Sincerely, T. Glenn Foster Chief, Regulatory Review and Reinvention Branch Standards and Rulemaking Division 2#

Page 3Drakeford, Carolyn (PHMSA) N t'ekel-5 3172./0~ 5PI88 ~ t/2-~ 1 or From: Sent: To: Subject: Attachments: INFOCNTR (PHMSA) ~a.. fferte S Tuesday, September 04, 2012 1:22 PM Drakeford, Carolyn (PHMSA) RE: Portable Oxygen Concentrator - battery cell/lithium content ( J..., - D { fj 5· 11-0285.pdf Carolyn, We received the following request for a formal letter of interpretation. Thanks, Victoria From: Olsavsky, Joseph [mailto:joseph.olsavsky@philips.coml Sent: Tuesday, September 4, 2012 12:22 PM To: infocntr@dot.gov Cc: Richardson, Gerry; Whitcher, Douglas Subject: Portable Oxygen Concentrator - battery cell/lithium content The purpose of this email is to request a clarification on the Hazardous Materials Regulations (HMR) for the transportation oflithium ion batteries; specifically, we are investigating an engineering proposal to change our current battery pack for our SimplyGo Portable Oxygen Concentrator device: from 7.92 grams total lithium content (93 watt-hour pack) to 10.8 grams total lithium content (127 watt-hour pack). Our 7.92 gram battery configuration (used in the SimplyGo device) is currently not subject to the HMR (see attached determination letter). In reviewing the transportation and labeling requirements specified in Section 173 and the hazardous materials table found in Section 172.101 of the HMR, we would like to determine what shipping regulations and special packaging/markings (if any) are in effect based on lithium weight (for primary cells and batteries) and equivalent lithium content (for lithium ion cells and batteries). It is my understanding that the following regulations apply: Primary Lithium Ion & Polymer Shipping Special Packaging/Markings Cell/Battery Cell/Battery Classification/Testing Max. Lithium Max. Lithium Content Content grams 5.0 grams/25 5.0 grams/25 grams -Excepted/ T1-T6 None (excepted from regulations if the battery passes - excepted from regulations if the UN Manual of tests and the battery passes the UN Criteria Tl-T6 tests Manual oftests and Criteria Tl-T6 tests. 1#

Page 4Based on the information provided above and our understanding of the regulations we would request clarification to the following questions: 1. 2. Would the 10.8 gram/127 watt-hr battery pack require Class 9 markings, label, specification packaging, and shipping papers? What ramifications does this have on airline travel; i.e. SF AR 1 06 ? Thank you in advance. Best Regards, Joe Joseph E. Olsavsky, RAC Sr. Manager - HRC Regulatory Affairs Philips Respironics 1740 Golden Mile Highway Monroeville, P A 15146 Office: 724-387-7562 Fax: 724-387-7490 2#