# O2 Concepts, LLC — Hazardous Materials Safety Interpretation

- **operation:** document
- **citation:** 11-0044
- **title:** O2 Concepts, LLC — Hazardous Materials Safety Interpretation
- **source type:** guidance
- **agency:** Pipeline and Hazardous Materials Safety Administration
- **status:** guidance
- **official:** true
- **published on:** 2011-03-23
- **effective on:** Not available
- **summary:** 11-0044 response to O2 Concepts, LLC concerning 173.185.
- **machine formats:** - **json:** https://regulus.evalyn.ai/document/phmsa-interpretation-11-0044.json
- **markdown:** https://regulus.evalyn.ai/document/phmsa-interpretation-11-0044.md
- **app url:** https://regulus.evalyn.ai/document/phmsa-interpretation-11-0044
- **source url:** https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretations/2011/110044.pdf
**body:**

<<<PAGE 1>>>

U.S. Department of Transportation 1200 New Jersey Avenue. SE
washington, DC 20590
Pipeline and Hazardous Materials
Safety Administration
MAR 23 2011
Ms. Kathryn G. Forgione
Vice President of Quality
02 Concepts, LLC
14001 McAuley Blvd., Suite 170
Oklahoma City, OK 73134
Ref. No.: 11-0044
Dear Ms. Forgione:
This responds to your February 15,2011 letter regarding the applicability ofthe Hazardous
Materials Regulations (HMR; 49 CFR Parts 171-180) to a portable oxygen concentrator.
Specifically you ask ifthe OxLife Independence oxygen concentrator is compliant with
Special Provision 188. For your information, in December 2008 this office responded to a
similar request for interpretation from OxLife, LLC (Ref. No. 08-0237). In your letter you
indicated that in 2010 your company purchased the appropriate legal rights to the OxLife
Independence oxygen concentrator.
The information you provided in your letter, reiterates that provided by OxLife LLC in 2008
concerning the contents ofthe OxLife Independence oxygen concentrator. You indicate the
following:
1. The pressure of the oxygen in the device does not exceed 40.6 psia at 20 degrees C;
2. The cells contain no more than 1.5 grams of lithium equivalent content;
3. The lithium ion battery contains an aggregate equivalent lithium content ofnot more
than 8 g;
4. The device contains no other materials subject to the HMR; and
5. The batteries are fully contained in equipment and packaged in a manner to preclude
sparks or the generation ofa dangerous quantity ofheat.
Based on the information provided, the OxLife Independence portable oxygen concentrator
meets the requirements of Special Provision 188. Provided it continues to meet the
requirements established in Special Provision 188, it is not otherwise subject to the HMR.

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You should also note that F ederal Aviation Administration (F AA) approval is required before
these electronic devices may be used by passengers on board aircraft. The FAA published a
final rule in the Federal Register regarding these devices on July 12,2005 (70 FR 40156). A
copy ofthe rulemaking is enclosed.
I hope this answers your inquiry. If you need additional assistance, please contact the
Standards and Rulemaking Division at 202-366-8553.
Sincerely,
BenSupko
Acting Chief, Standards Development Branch
Standards and Rulemaking Division
Enclosure

<<<PAGE 3>>>

A-~2
CONCEPTS
February 15, 2011
Office of Hazardous Materials Standards
U.S. DOT/PHMSA (PHH-I0)
1200 New Jersey Avenue, SE East Building, 2nd Floor
Washington, DC 20590
Attention: Mr. Edward T. Mazzullo, Director
Dear Mr. Mazzullo,
In 2010, 02 Concepts, LLC purchased all intangible assets to the' OxLife Independence, a Portable
Oxygen Concentrator, from OxLife, LLC who obtained FDA clearance for this product on April 16, 2008
under K080082.
The device is a portable oxygen concentrator designed to deliver supplemental oxygen to adult patients.
This product is manufactured according to FDA's Quality System Regulation part 820 and Quality
Management System according to ISO 13485.
02 Concepts, LLC is preparing to launch the OxLife Independence (Model #800-0001) and is requesting a
confirmation that the OxLife Independence is compliant with the HMR, Special Provision 188.
The OxLife Independence meets the following criteria:
1. 3. The pressure of the oxygen in the device does not exceed 40.6 psia at 20 degrees C.
2. The cells contain no more than 1.5 grams of lithium equivalent content.
The lithium ion battery contains an aggregate equivalent lithium content of not more than 8g and
has been found to be compliant with UN document ST/SG/AC.I0/11 Rev: 3: "Amendments to the
third Revised Edition of the Recommendations on the Transport of Dangerous Goods, Manual of
Tests and Criteria'"
4. 5. The device contains no other materials subject to the HMR.
The batteries are fully contained in equipment and packaged in a manner to preclude sparks or
the generation of a dangerous quantity of heat.
If any additional information is required, please contact me via e-mail atkforgione@02-concepts.com.
~IIY' ,VGiV .
Kathryn G~ione ~
Vice President of Quality
02 Concepts, LLC
Corporate: 14001 McAuley Blvd, Suite 170, Oklahoma City, OK 73134
Factory: 15 Commerce Road, Newtown, CT 06470
Telephone: 405.463.4950 • Toll Free: 877.867.4008 • Facsimile: 877.867.1314

<<<PAGE 4>>>

40156 Federal Register / Vol. 70, No. 132 / Tuesday, July 12, 2005 / Rules and Regulations
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Parts 11 and 121
[Docket No.: FAA–2004–18596; SFAR No.
106]
RIN 2120–AI30
Use of Certain Portable Oxygen
Concentrator Devices Onboard Aircraft
AGENCY: Federal Aviation
Administration (FAA), DOT.
ACTION: Final rule.
SUMMARY: This Special Federal Aviation
Regulation (SFAR) will permit
passengers to use certain portable
oxygen concentrator (POC) devices on
aircraft, provided certain conditions in
this SFAR are satisfied. The SFAR
includes a POC preparation requirement
for carry-on baggage transport, and a
battery-packaging standard necessary for
the safe carriage of extra POC batteries
in carry-on baggage. This rulemaking
action is necessary to address the
travelling needs of people on oxygen
therapy.
DATES: This SFAR becomes effective
August 11, 2005.
FOR FURTHER INFORMATION CONTACT:
David L. Catey, Air Transportation
Division, AFS–200, Federal Aviation
Administration, 800 Independence
Avenue SW., Washington, DC 20591;
telephone (202) 267–3732.
SUPPLEMENTARY INFORMATION:
Availability of Rulemaking Documents
You can get an electronic copy using
the Internet by:
(1) Searching the Department of
Transportation’s electronic Docket
Management System (DMS) web page
(http://dms.dot.gov/search);
(2) Visiting the Office of Rulemaking’s
web page at http://www.faa.gov/avr/
arm/index.cfm; or
(3) Accessing the Government
Printing Office’s web page at http://
www.access.gpo.gov/su_
docs/aces/
aces140.html.
You can also get a copy by submitting
a request to the Federal Aviation
Administration, Office of Rulemaking,
ARM–1, 800 Independence Avenue
SW., Washington, DC 20591, or by
calling (202) 267–9680. Make sure to
identify the amendment number or
docket number of this rulemaking.
Anyone is able to search the
electronic form of all comments
received into any of our dockets by the
name of the individual submitting the
comment (or signing the comment, if
submitted on behalf of an association,
business, labor union, etc.). You may
review DOT’s complete Privacy Act
statement in the Federal Register
published on April 11, 2000 (Volume
65, Number 70; Pages 19477–78) or you
may visit http://dms.dot.gov.
Small Business Regulatory Enforcement
Fairness Act
The Small Business Regulatory
Enforcement Fairness Act (SBREFA) of
1996 requires FAA to comply with
small entity requests for information or
advice about compliance with statutes
and regulations within its jurisdiction. If
you are a small entity and you have a
question regarding this document, you
may contact its local FAA official, or the
person listed under FOR FURTHER
INFORMATION CONTACT. You can find out
more about SBREFA on the Internet at
http://www.faa.gov/avr/arm/sbrefa.cfm.
Authority for This Rulemaking
The FAA is authorized to issue this
pursuant to 49 U.S.C. 44701. Under that
section, the FAA is authorized to
establish regulations and minimum
standards for ‘‘other practices methods
and procedure the Administrator finds
necessary for air commerce and national
security.’’
Background
This final rule responds to comments
received on notice of proposed
rulemaking (NPRM) titled ‘‘Use of
Portable Oxygen Concentrator Devices
Onboard Aircraft,’’ (69 FR 42324; July
14, 2004). The NPRM proposed a
Special Federal Aviation Regulation
(SFAR) to allow passengers to operate
certain portable oxygen concentrator
(POC) devices on aircraft if certain
conditions detailed in the proposal were
met.
As stated in the NPRM, the FAA
recognizes that there is a critical need to
improve service for passengers who
have a medical need to travel with
medical oxygen. Passengers requiring
medical oxygen during air travel have
faced significant difficulties obtaining
adequate air service. Many carriers do
not provide medical oxygen during air
travel. Those carriers that provide the
service often charge for the service—
sometimes at a cost that equals the price
of a ticket. Additionally, it can be
difficult to coordinate service between
the carrier and a supplier of medical
oxygen to ensure passenger coverage
both at the terminal and on the aircraft.
Sometimes, the passenger must spend at
least part of the time travelling without
medical oxygen due to service problems
with the oxygen provider.
Compressed oxygen is regulated as a
Hazardous Material by the Pipeline and
Hazardous Materials Safety
Administration (PHMSA), formerly the
Research and Special Programs
Administration (RSPA), under title 49
CFR 172.101. The FAA also regulates
oxygen furnished by aircraft operators to
passengers who have a medical need for
oxygen on board the aircraft. Oxygen is
highly regulated because, as an oxidizer,
it can enhance an existing fire, and it
can support combustion of certain
flammable materials, whether or not an
ignition source is present. The FAA’s
medical oxygen regulations, 14 CFR
121.574, 125.219, and 135.91, currently
allow aircraft operators to furnish
equipment for the storage, generation, or
dispensing of oxygen to passengers
provided all of the following conditions
are met:
The equipment is:
1. Furnished by the certificate holder;
2. Of an approved type or is in
conformity with the manufacturing,
packaging, marking, labelling and
maintenance requirements of 49 CFR
parts 171, 172 and 173 except
173.24(a)(1);
3. Maintained by the aircraft operator
in accordance with an approved
maintenance program;
4. Free of flammable contaminants on
all exterior surfaces;
5. Capable of providing a minimum
mass flow of oxygen to the user of four
liters per minute (this provision is not
contained in either part 125 or 135
regulations);
6. Constructed so that all valves,
fittings and gauges are protected from
damage; and
7. Appropriately secured.
Recently new medical oxygen
technologies have been approved by the
Food and Drug Administration that
reduce the risks typically associated
with compressed oxygen. Two
companies—AirSep Corporation and
Inogen, Inc.—have developed small
POCs that work by filtering out nitrogen
from the air and providing the user with
oxygen at a concentration of about 90%.
The POCs operate using either
rechargeable batteries or, if approved by
the FAA, aircraft electrical power.
In addition, PHMSA, formerly RSPA,
has determined that the POCs are not
hazardous materials. Thus they do not
require the same level of special
handling as compressed oxygen, and are
safe for use onboard aircraft provided
certain conditions for their use are met.
Summary
This SFAR establishes requirements
applicable to passenger-supplied POCs
used on aircraft. With the adoption of
this rule, passengers will be able to
choose between two different kinds of
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Federal Register / Vol. 70, No. 132 / Tuesday, July 12, 2005 / Rules and Regulations
40157
portable oxygen concentrator (POC)
devices to operate onboard an aircraft
during travel. The NPRM published in
July 2004 explained the proposal and
this final rule adopts much of that
original proposal, with some
modifications, including:
1. Some proposed requirements that
would have been placed on air carriers
are now the responsibility of the POC
user;
2. The Inogen One POC, mentioned
only as being studied in the NPRM, is
included as an eligible portable
electronic device in the SFAR in
response to comments;
3. We will allow passengers using a
POC to walk around the cabin while
carrying the device. However, when a
passenger has a medical need to use a
POC during movement on the surface,
takeoff, and landing, the person using
the POC must be seated in seat location
so as not to restrict other passenger’s
access to, or use of, any required
emergency, or regular exit. Additionally,
the POC user must be seated in a
location so as not to restrict access to
the aisle(s) of the passenger
compartment. Passengers who do not
have a medical need to use a POC
during movement on the surface, takeoff
and landing, and are not seated in
accordance with the preceding
requirements, must properly stow the
POC so it does not block access to the
aisleway (e.g., under the passenger seat
in front of the user). In either case, POCs
and the extra batteries needed to power
them must be properly stowed in
accordance with the applicable carry-on
baggage requirements of 14 CFR 91.523,
91.525, 121.285, 121.589, 125.183, and
135.87.
4. Several extra batteries may be
required to power the POCs for some
flights and we are including a battery-
packaging standard for POC batteries
included in carry-on baggage. (Section
3(b)(6) of the SFAR)
We don’t feel that any of these
modifications go outside the scope of
the original NPRM since we specifically
cited the Inogen One POC and sought
comment on who should be responsible
for certain aspects of the rule. All
comments are addressed below.
The SFAR is an enabling rule, which
means that no aircraft operator is
required to allow passengers to operate
these devices onboard, but they may
allow them to be operated onboard. If an
aircraft operator chooses to allow a
passenger to operate these devices
onboard the aircraft operator’s aircraft
the conditions in the SFAR must be met.
Presently, there are only two
acceptable POCs on the market (Inogen
and Airsep) and we cannot predict how
future products may be developed and
work. Accordingly, while we are
committed to developing a performance-
based standard for all future POC
devices, we do not want to prematurely
develop standards that have the effect of
stifling new technology of which we are
unaware. It is only under exceptionally
rare circumstances that the FAA would
permit a specific product to be used in
a regulation. However, we believe such
an approach is appropriate in this case
until such time that a performance-
based standard can be developed
because the rule accommodates
individuals who would otherwise be
unable to fly. This approach is
consistent with the Department of
Transportation’s desire to reduce travel
barriers to persons with disabilities.
Reference Material
After reviewing the, ‘‘United Kingdom
Civil Aviation Authority study titled
‘‘Dealing With In-Flight Lithium Battery
Fires in Portable Electronic Devices’’
,
and recent incident data detailing
battery abuse and short circuit problems
associated with the carriage of batteries,
it became clear that we must provide a
means for reducing the hazard of
personal injury and fire from loose POC
batteries included as carry on items in
passengers’ carry-on baggage. Although
most battery pack manufacturers
employ various protective devices to
prevent abuse such as thermal or
pressure disconnects and shutdown
separators to prevent battery
overheating and fires, abuse conditions
such as physical damage to the cell(s) or
external short circuits do occur. Abuse
of the battery can cause those safeguards
to become ineffective unless other
protective measures, such as battery
outer protective packaging, are used.
(See the discussion under the subtopic
heading ‘‘Safety of Carrying Multiple
Batteries’’ under the main topic heading
‘‘Discussion of Comments’’ below).
Related Activity
The FAA’s Office of Security and
Hazardous Materials is coordinating
with the Office of Hazardous Materials
Safety in the DOT’s Pipeline and
Hazardous Materials Safety
Administration (PHMSA) to examine
battery safety. More specifically,
PHMSA is considering a rulemaking
that is aimed at preventing short circuit,
sparking, and heat from all batteries and
battery-powered devices in
transportation. No formal or official
rulemaking has begun at the time this
SFAR is being published.
Discussion of Comments
The NPRM leading to this final rule
was published in the Federal Register
on July 14, 2004. We set a 30-day
comment period ending on August 13,
2004. The Air Transport Association
(ATA) requested that we extend the
comment period for an additional 60
days to allow more time to examine the
proposal and submit appropriate
comment. After reviewing the ATA’s
request, we determined that they
misunderstood the proposal and that
such a significant extension would
unnecessarily delay the final decision
on this rule. We extended the comment
period an additional 15 days to allow
additional time to review and analyse
the proposal.
The new comment period closed on
August 30, 2004. As of September 8,
2004, we had received about 2,270
comments. All comments submitted
after the comment period closing date
were considered in this final rule.
Support for this proposed SFAR was
overwhelming. Of the 2,270 comments,
2,267 favored at least the spirit of our
proposal. Commenters had many
substantive and helpful comments that
suggested changes to our original
proposal. Many of the comments were
used to draft our Final Rule, a product
that benefits greatly from the thought
and detail put into the comments.
A large majority of the comments in
favor of our proposal were form letters
organized by a number of interest
groups supporting the SFAR. We also
received approximately 40 letters with
extensive substantive comments,
including questions, comments,
suggestions, and ideas. We are
responding to both the suggestions
found in the form letters, as well as the
ideas and suggestions found in the 40
letters with extensive substantive
comments.
We asked for comments on the
following questions in the NPRM:
1. Should the aircraft operator be
required to inform the user about the
availability of electrical outlets suitable
for the Airsep portable oxygen
concentrator?
2. Should the user be required to carry
batteries for the duration of the flight
including reasonable delays if there are
electrical outlets available on the flight?
3. Are the meanings of the terms
‘‘anticipated delay’’ and ‘‘reasonable
delay’’ sufficiently clear?
Question 1. Use of Electrical Power
Potential travellers commented in
support of the aircraft operator
informing the travelling public of the
availability of electrical outlets on board
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40158 Federal Register / Vol. 70, No. 132 / Tuesday, July 12, 2005 / Rules and Regulations
aircraft. Potential travellers requiring
oxygen therapy stated that other
passengers routinely plug a laptop
computer or other entertainment device
into the aircraft’s power supply, so a
POC user should be given the same
opportunity. Some commenters feel that
a POC user should be given priority over
all users of other types of portable
electronic equipment.
In contrast, industry and air carrier
comments (including American Trans
Air and the Air Transport Association)
strongly objected to informing
passengers of the availability of
electrical outlets to power a POC. These
commenters stated that electrical outlets
are not widely available on the aircraft
and that a carrier cannot guarantee
access to an outlet because outlets may
not be available for a particular seat
assignment or, aircraft without outlets
may be substituted unexpectedly for
aircraft with outlets. Additionally, these
commenters noted that some electrical
outlets are designed to shut off
automatically if the aircraft experiences
electrical overload conditions. Any of
these scenarios would create a problem
for a POC user that had planned on
using the aircraft’s electrical supply and
had not brought an appropriate number
of batteries. American Trans Air was
concerned with passengers being
allowed to plug anything into the ship’s
power because it could open a
‘‘Pandora’s Box.’’
FAA Response: The FAA agrees that
if aircraft operators obtain FAA
authorization, access to the electrical
power supply of the aircraft can be
made available for a POC user, but it is
not requiring the operator to inform the
passenger about the availability of
electrical outlets. There are too many
variables that may change before the
flight that could affect the availability of
electrical outlets. If carriers wish to
provide such information to potential
POC users it is their choice to do so. The
FAA does not have the authority under
the Air Carrier Access Act to require
such an action.
If, for example, an operator of a
transport category airplane provides a
passenger access to aircraft electrical
power for use with a POC, the operator
must ensure that the installation and
cabling, up to the point where the
passenger plugs in the POC, meets the
airworthiness standards of 14 CFR
25.1301, 25.1309, 25.1353, and 25.1357.
These sections ensure that the wiring
and circuit protection are sufficient for
the intended use. The sections also
ensure that the POC will not negatively
affect aircraft power.
In regard to the issue about giving
POC users priority to use any available
electrical outlets over people who are
not using POCs, the Department of
Transportation (DOT), under the Air
Carrier Access Act, would have to assess
whether the law requires a POC user to
have such priority access.
Question 2 and 3. Number of Batteries
in Carry-on To Address Anticipated or
Reasonable Delay
In the NPRM we asked whether the
user should be required to carry
batteries for the duration of the flight,
including enough to cover reasonable
delays if there are electrical outlets
available on the flight. We also asked
whether the terms ‘‘anticipated delay’’
and ‘‘reasonable delay’’ were
sufficiently clear to a user to enable
them to make the decision as to how
many batteries would be needed.
Most commenters felt that those terms
were not sufficient to determine the
number of batteries that would be
necessary in the event of any type of
delay. Some suggested we simply
require enough batteries to cover 150%
of the flight time. Airbus commented
that the user should be responsible for
carrying the appropriate number of
batteries to cover for delays, even if
there are electrical outlets available on
the aircraft. Airbus specifically notes
that the outlets can only serve as backup
for the devices under certain conditions
because they will not always be
available, and can be limited in power
rating (typically around 75 Watts).
FAA Response: The FAA does not
believe that simply adding 150% to the
scheduled flight time is adequate to
cover the number of batteries that may
be needed by an oxygen dependent
passenger. Flight time in the Official
Airline Guides, for example, only
accounts for the usual time between
aircraft pushback at the departure
airport gate and the aircraft’s arrival at
the gate at the destination airport. It
does not account for delays that occur
after passengers are boarded at the
departure gate; after pushback from the
departure gate but before takeoff; during
in-flight holding at the arrival airport
awaiting landing clearance; as a result of
flight to a diversion airport due to either
adverse weather conditions at the
planned destination airport or an
aircraft emergency; and after landing at
the planned destination airport.
Scheduled travel time then would not
appear, in our eyes, to account for all
contingencies during travel. For
example, time spent on the ground prior
to departure and while awaiting arrival
at a gate can easily exceed an hour.
Weather delays commonly exceed an
hour if the weather conditions at the
departure or planned destination
airports cause air traffic instrument
flight rules aircraft separation criteria to
be increased at peak airport departure
and arrival times. Under the 150% flight
time increase comment, a 2 hour flight
would only require enough batteries to
power the POC for 3 hours. Under that
scenario, a weather delay of an hour
coupled with normal ground time,
could easily drain the battery power
before the trip was completed.
The passenger’s physician can help
the passenger determine how much
oxygen the patient may need on a flight.
The physician, in the physician
statement, can note whether the
passenger needs oxygen for the entire
air travel time, including ground and in-
flight delays, or only portions of those
times. It is then up to the user to carry
the number of extra batteries necessary
to cover the possible contingencies.
Generic Standard or Manufacturer
Specific
Many commenters, including Inogen,
Inc., the Paralyzed Veterans of America,
National Home Oxygen Patients
Association, and the American Thoracic
Society, requested that we not limit
POCs by specific brand or manufacturer.
These commenters wanted a generic
standard that would apply to different
types of devices. Over 150 commenters,
however, asked that if we did limit the
POC by manufacturer we include the
Inogen One POC in the SFAR. Overall,
there was broad support for writing a
rule that would provide standards for a
manufacturer to meet in order to have
an acceptable model of POC.
FAA Response: As noted in the
NPRM, the FAA was reviewing the
Inogen One POC and accompanying
material at the time of the NPRM’s
publication. The FAA’s review and
evaluation had to be completed prior to
determining whether the Inogen One
POC would be eligible to be operated as
a POC, as well as a portable electronic
device for use onboard aircraft. Since
the issuance of the NPRM, we have
completed our review of the Inogen POC
and we agree with commenters that the
Inogen One device is functionally
similar to the AirSep POC and should
be included in the Final Rule. The FAA
has determined that this device may be
operated onboard aircraft, subject to
certain conditions in the regulation, and
the SFAR will include this device along
with the Airsep Lifestyle POC.
We agree that future rulemaking
should include generic standards that
future POC’s would be required to meet.
Since this future rulemaking will
require time to develop the standards,
the FAA will proceed, in the interim,
with this SFAR. This SFAR is the
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Federal Register / Vol. 70, No. 132 / Tuesday, July 12, 2005 / Rules and Regulations
40159
quickest way to enable the use of these
two devices by passengers who have a
medical need to continue to receive
oxygen therapy during their air travel.
The FAA will create a generic standard
for all POCs that will be the basis for a
follow-on rulemaking that will amend
14 CFR permanently. This SFAR is
intended to be the first step in allowing
passenger-furnished POC devices to be
used on aircraft.
Role of FAA and RSPA (Now PHMSA)
in Determining a Material ‘‘Hazardous’’
Several commenters asked
specifically about a statement we
included in the NPRM that pertained to
the review and approval process for
devices that may be considered non-
hazardous by RSPA (now PHMSA) and
whether or not the FAA can overrule
PHMSA on such a determination.
FAA Response: The two steps in the
process, while related, are not
exclusively connected to one another. A
PHMSA determination that a medical
oxygen device is not regulated as a
hazardous material does not
automatically qualify such a device as
safe for use in air commerce. The FAA
also must review and evaluate the
device to determine if there are any
additional safety concerns pertaining to
the use of the product on board an
aircraft. A ruling by the FAA that such
a device cannot be carried on board an
aircraft, however, does not mean that
the device is a hazardous material under
PHMSA’s regulations in Title 49.
Requiring Airlines To Permit the Use of
POCs
Another commenter requested that we
‘‘require’’ aircraft operators to allow
passengers needing oxygen therapy to
carry on and operate the POCs onboard
aircraft. The NPRM only stated that
operators may choose to allow
passengers on oxygen therapy to carry
on and operate the devices onboard
their aircraft.
FAA Response: The FAA does not
have the statutory authority under the
Air Carrier Access Act to require air
carriers to allow these devices to be
carried or operated onboard their
aircraft. That authority is granted only
to the Department of Transportation
(DOT). It is DOT’s decision whether or
not to designate these devices as
assistive devices, and to require air
carriers to allow the transport of these
devices and, in conjunction with the
FAA, require air carriers to allow
passenger operation of these devices
onboard aircraft. This SFAR will open
the door for air carriers to take
advantage of the new market available
through passenger use of these devices.
Use of POCs During Takeoff and
Landing and Passenger Movement in
Flight
Commenters wanted to make sure that
our rule allowed passengers using a
POC to operate the device for the
entirety of the flight if necessary. Many
oxygen users’ physicians may stipulate
that there is a medical need for their
patients to use a POC during the entire
flight, including movement on the
surface, takeoff, and landing. Movement
on the surface, takeoff, and landing are
times when the current regulations
require that, among other things,
medical oxygen equipment be properly
stowed, and each person using the
equipment to be seated at a seat location
that does not restrict passenger access
to, or use of, any required exit
(emergency or regular), or the aisle(s) in
the passenger compartment.
FAA Response: This final rule will
allow passengers to use a POC during
the flight, including movement on the
surface, takeoff, and landing.
Additionally, once passengers are
allowed to move about the cabin of the
aircraft, they will be allowed to carry a
POC along with them. This allowance is
specifically cited in the new Section
3(a)(6) in the regulatory text of this final
rule.
A new section was also included in
the regulatory text that requires the
physician statement to include
information on the extent to which the
user must use the portable oxygen
concentrator (e.g., During takeoff and
landing only, during the whole flight,
only when needed, etc.)
Safety of Carrying Multiple Batteries
One commenter raised concerns about
the safety of carrying multiple extra
batteries in carry-on baggage to be used
to power the POC.
FAA response: This commenter’s
concerns are shared by the FAA. We are
adopting the requirement that
passengers whose physician statement
stipulates a medical need for extensive
oxygen use must carry enough extra
batteries to power the POC for the
duration of time the passenger may be
on board the aircraft.
Comments received in response to the
NPRM stated that the battery life for the
AirSep Lifestyle POC is approximately
50 minutes, while the Inogen One has
a battery life of approximately 2 to 3
hours. Since the battery life for these
devices is so short, it is likely that
passengers using these devices may
have to carry many extra batteries
onboard the aircraft in order to comply
with their physician’s oxygen
prescription. The number of extra
batteries must be able to power the POC
in the event the aircraft operator does
not permit these devices to be powered
by the aircraft electrical system, or the
aircraft electrical system is inoperative
or otherwise unusable.
Therefore, the FAA is including a new
section in the SFAR. Section 3(b)(6)
requires the user to ensure that all POC
batteries carried onboard aircraft as
carry-on baggage are protected from
short-circuit problems, and are
packaged in a manner that protects them
from physical damage. Protection from
short-circuit problems may be provided
by batteries designed with recessed
battery terminals or by packaging that
keeps the battery terminals from
contacting metal objects (including the
battery terminals of other batteries).
When a battery-powered oxygen
concentrator is carried onboard aircraft
as carry-on baggage and is not intended
to be used during flight, the battery
must be removed and packaged
separately, unless the concentrator
contains at least two effective protective
features to prevent accidental operation
and battery overheating during
transport.
The passenger will be responsible for
ensuring that all extra batteries carried
in carry-on baggage are properly
packaged, but we do not envision
passengers packaging the batteries
themselves.
A POC manufacturer may not be able
to develop a product to meet the
packaging standard in this SFAR by the
time the rule becomes effective (30 days
after publication). However, the battery
packaging standard contained in the
regulatory language of this SFAR must
be met before the extra batteries will be
allowed as carry-on baggage onboard the
aircraft. Companies with experience
meeting shipping standards will likely
be able to assist a passenger to meet this
standard.
We believe passengers can also
arrange for the following entities to
package extra POC batteries to meet the
standard:
—Homecare providers;
—Airlines;
—Other entities specializing in small
package shipments.
As for the POC itself, we anticipate
the homecare provider would be able to
prepare the device for transport.
There is a history of battery problems
with other portable electronic devices
when a battery is being charged during
flight. We currently do not have data to
establish a limit on the recharging of
POC batteries during flight. Therefore, if
the aircraft electrical system is available
to recharge a POC battery, it is currently
permissible to do so under this SFAR.
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40160 Federal Register / Vol. 70, No. 132 / Tuesday, July 12, 2005 / Rules and Regulations
In the future, the FAA may consider
developing a technical standard order
(TSO) to reduce the risk of overcharging
for certain types of rechargeable
batteries in portable electronic devices
that are carried in the aircraft passenger
compartment.
Battery Backup for the POC in the
Event of Failure
Some comments we received asked
what sort of contingency or emergency
precautions would be taken if a POC
were to fail during the flight, or if
battery power ran out during the flight.
The American Association for
Respiratory Care suggested that, if a
POC malfunctions, the flight crew
should provide the user access to
supplemental oxygen from the
emergency oxygen source. The National
Home Oxygen Patients Association also
supports the idea of consulting with the
patient if a POC fails, and relying on the
emergency medical oxygen that would
be available if an airline-provided
oxygen system were to fail. Access to
the aircraft’s emergency oxygen would
eliminate the need to divert the flight in
many instances.
FAA Response: We agree that the
appropriate action, in case of aircraft
electrical power or battery failure,
would be to refer to the passenger’s
physician statement and consult with
the passenger using the POC. The
crewmember should determine, through
the statement and discussion, the
person’s medical need for oxygen use
and provide access to the aircraft’s first
aid oxygen equipment if necessary.
However, it should be noted that only
aircraft required to be operated under 14
CFR part 121 are required to be
equipped with first aid oxygen
equipment. We do not feel it is
necessary to include this particular
detail in this SFAR, but strongly
encourage the aircraft operator to make
the availability of first aid oxygen
equipment clear to the passengers who
may have a medical need for it. We also
encourage passengers who have a
medical need for lengthy periods of
oxygen use to ensure that this
equipment is available before arranging
for a flight.
Application of RTCA/DO–160D, Section
21, Category M (Classified as a Medical-
Portable Electronic Device)
We received comments with concern
to section 3(a)(1) of the proposed rule
that required the aircraft operator to
ensure that a POC does not interfere
with electrical, navigation, or
communication equipment on which
the device is being used. Several
commenters felt that this requirement
may mean that each aircraft operator
had to test each device for every model
of aircraft they are flying to see if it is
safe. For instance, as the joint comment
headed by the American Thoracic
Society noted, the requirement would
seem to mean that if U.S. Airways tested
the POC device on a Boeing 747 and
found that there was no interference,
Delta Airlines would still have to test
the same device on the same model of
aircraft for themselves. The Air
Transport Association echoed the
question, and sought some answers
about whether or not the FAA’s
Advisory Circular (AC) 91.21–1A would
be applicable to a POC. If the POC were
tested to the standard established for a
medical-portable oxygen device (M–
PED) contained in RTCA Document
DO–160D, would that be acceptable to
meet the requirement of section 3(a)(1)
of the SFAR?
FAA Response: A POC, whether it is
the Inogen One or the AirSep Lifestyle,
is considered a medical-portable
electronic device (M–PED), and thus is
eligible to meet the standards contained
in RTCA DO–160D. Both devices fall
under the scope of AC 91.21–1A, and
each manufacturer can test their device
to the standard called for in the AC. It
must be clear though that the
requirement found in section 3(a)(1)
remains applicable to the aircraft
operator. If a POC manufacturer tests the
device to meet the RTCA standard and
shows that it meets the standard, the
manufacturer may provide the positive
testing results to the aircraft operator on
the POC itself. The aircraft operator will
have to be able to show that the device
has been tested and meets the
applicable standard regardless of the
test method used.
If either the Inogen or AirSep POC
have been tested to meet the RTCA
standard found in AC 91.21–1A, and the
test results are provided to, and verified
by, the aircraft operator, no further
testing by the aircraft operator would be
required.
POC as Carry on Baggage
We received comments from several
interested parties, including the
American Association for Respiratory
Care, the American Thoracic Society,
the Pulmonary Hypertension
Association, and others that requested
we allow passengers to bring two carry-
on bags if they are using a POC on the
flight. Their recommendation would not
include the POC itself as one of those
carry-on items, only the regular carry-on
baggage common for most travellers,
and the extra batteries that will be
necessary for each flight.
FAA Response: The FAA does not
agree with the recommendations of the
commenters. Because aircraft operators’
aircraft passenger compartment
configurations have differing capability
to accommodate the safe stowage of
different sizes and amounts of carry-on
baggage, the FAA cannot simply
establish a requirement in its
regulations that, henceforth, aircraft
operators subject, for example to the
requirements of 14 CFR 121.589, must
allow POC users to bring into the
passenger compartment, two carry-on
bags and the extra POC batteries in
addition to their POC. The FAA’s
regulations pertaining to the carriage of
carry-on baggage in passenger
compartments of aircraft, 14 CFR
91.523, 91.525, 121.285, 121.589,
125.183, and 135.87, provide that no
aircraft operator may allow the carriage
of carry-on baggage on its aircraft unless
the applicable requirements prescribed
by those regulations are met.
The FAA plans to provide
information about the size and weight of
the POCs covered by this SFAR to
aircraft operators. This information may
cause certain operators to review their
carry-on baggage programs to determine
whether they may be able to
accommodate the carriage of the POCs.
Liquid Oxygen Devices Onboard
Aircraft
We received several comments,
mostly from individual commenters—
not from industry or interest groups,
asking why we couldn’t also allow
passengers to use the Helios liquid
oxygen device, or other
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