Interpretation Response #12-0195 ([Philips Respironics] [Mr. Joseph E. Olsavsky])

Below is the interpretation response detail and a list of regulations sections applicable to this response.

Interpretation Response Details

Response Publish Date: 11/13/2012

Company Name: Philips Respironics

Individual Name: Mr. Joseph E. Olsavsky

Location State: PA Country: US

View the Interpretation Document

Response text:

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, 2012 letter 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 accidental operation during transport. Furthermore, the Class 9 markings, labeling, and shipping paper provisions would be required.

Q2: 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? 

A2: 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

Regulation Sections