# Philips Respironics — Hazardous Materials Safety Interpretation

- **operation:** document
- **citation:** 12-0195
- **title:** Philips Respironics — Hazardous Materials Safety Interpretation
- **source type:** guidance
- **agency:** Pipeline and Hazardous Materials Safety Administration
- **status:** guidance
- **official:** true
- **published on:** 2012-11-13
- **effective on:** Not available
- **summary:** 12-0195 response to Philips Respironics concerning 172.102, 173.185.
- **machine formats:** - **json:** https://regulus.evalyn.ai/document/phmsa-interpretation-12-0195.json
- **markdown:** https://regulus.evalyn.ai/document/phmsa-interpretation-12-0195.md
- **app url:** https://regulus.evalyn.ai/document/phmsa-interpretation-12-0195
- **source url:** https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretations/2012/120195.pdf
**body:**

<<<PAGE 1>>>

U.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 2>>>

02: 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 3>>>

Drakeford, Carolyn (PHMSA)
N t'ekel-5
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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 4>>>

Based 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
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