[Federal Register: July 14, 2004 (Volume 69, Number 134)]
[Proposed Rules]
[Page 42323-42327]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14jy04-18]
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Part V
Department of Transportation
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Federal Aviation Administration
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14 CFR Parts 121, 125, and 135
Use of Certain Portable Oxygen Concentrator Devices Onboard Aircraft;
Proposed Rule
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DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Parts 121, 125, and 135
[Docket No. FAA-2004-18596; SFAR No. XX; Notice No. 04-10]
RIN 2120-AI30
Use of Certain Portable Oxygen Concentrator Devices Onboard
Aircraft
AGENCY: Federal Aviation Administration (FAA), DOT.
ACTION: Notice of proposed rulemaking (NPRM).
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SUMMARY: This action proposes to address the traveling needs of persons
on oxygen therapy by permitting the use of certain portable oxygen
concentrator devices on aircraft, providing certain conditions are
satisfied.
DATES: Send your comments on or before August 13, 2004.
ADDRESSES: Address your comments to the Docket Management System, U.S.
Department of Transportation, Room Plaza 401, 400 Seventh Street, SW.,
Washington, DC 20590-0001. You must identify the docket number FAA-
2004-18596 at the beginning of your comments, and you should submit two
copies of your comments. If you wish to receive confirmation that FAA
received your comments, include a self-addressed, stamped postcard.
You may also submit comments through the Internet to http://dms.dot.gov.
You may review the public docket containing comments to
these proposed regulations in person in the Dockets Office between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. The
Dockets Office is on the plaza level of the NASSIF Building at the
Department of Transportation at the above address. Also, you may review
public dockets on the Internet at http://dms.dot.gov.
FOR FURTHER INFORMATION CONTACT: James W. Whitlow, Office of the Chief
Counsel, AGC-2, Federal Aviation Administration, 800 Independence
Avenue SW., Washington, DC 20591; telephone (202) 267-3222; facsimile
(202) 267-3227.
SUPPLEMENTARY INFORMATION: Comments Invited: Interested persons are
invited to participate in the making of the proposed action by
submitting such written data, views, or arguments as they may desire.
Comments relating to the environmental, energy, federalism, or economic
impact that might result from adopting the proposals in this document
also are invited. Substantive comments should be accompanied by cost
estimates. Comments must identify the regulatory docket or notice
number and be submitted in duplicate to the DOT Rules Docket address
specified above.
All comments received, as well as a report summarizing each
substantive public contact with DOT personnel concerning this proposed
rulemaking, will be filed in the docket. The docket is available for
public inspection before and after the comment closing date.
All comments received on or before the closing date will be
considered by FAA before taking action on this proposed rulemaking.
Comments filed late will be considered as far as possible without
incurring expense or delay. The proposals in this document may be
changed in light of the comments received.
Commenters wishing FAA to acknowledge receipt of their comments
submitted in response to this document must include a pre-addressed,
stamped postcard with those comments on which the following statement
is made: ``Comments to Docket No. FAA-2004-18596.'' The postcard will
be date stamped and mailed to the commenter.
Availability of Rulemaking Documents
You can get an electronic copy using the Internet by taking the
following steps:
(1) Go to the search function of the Department of Transportation's
electronic Docket Management System (DMS) web page (http://dms.dot.gov/search
).
(2) On the search page type in the last four digits of the Docket
number shown at the beginning of this notice. Click on ``search.''
(3) On the next page, which contains the Docket summary information
for the Docket you selected, click on the document number of the item
you wish to view.
Background
The FAA is proposing this Special Federal Aviation Regulation
(SFAR) to address the traveling needs of persons on oxygen therapy. The
FAA has been made aware of the critical need for improved service to
passengers who must travel with oxygen while on the aircraft.
Consequently, the FAA is proposing this SFAR to permit the use of
certain portable oxygen concentrator devices on aircraft, provided
certain conditions are satisfied. The NPRM proposes to limit the SFAR
to the AirSep LifeStyle Portable Oxygen Concentrator because this is
the only device of this type the FAA has evaluated and determined to be
safe. Other devices may be added to the SFAR after the FAA has been
satisfied that they can be safely used on board aircraft. The FAA seeks
comments, particularly technical information about other assistive
devices which may be of benefit to users of medical oxygen delivery
systems, to enable the FAA to evaluate the safety of these devices and
the feasibility of including these devices in the SFAR. In order for an
oxygen delivery system to be considered safe by the FAA for use onboard
an aircraft, at a minimum the Research and Special Programs
Administration (RSPA) must first determine that the device does not
contain hazardous materials and is not subject to its hazardous
materials regulations.
Currently, 14 CFR 121.574, 125.219, and 135.91 allow a passenger to
carry and operate equipment generating, storing or dispensing medical
oxygen on board an aircraft only if the equipment is furnished by the
certificate holder and certain other conditions are satisfied. The
oxygen furnished in compliance with these regulations is compressed
oxygen, which is regulated as a hazardous material in transportation by
the RSPA. Several of the conditions contained in Sec. Sec. 121.574,
125.219, and 135.91 are designed to ensure that the oxygen cylinder is
in compliance with RSPA's hazardous materials regulations. Other
conditions are designed to ensure that the oxygen is dispensed safely
while in use on the aircraft. Currently, air carriers are not required
to provide medical oxygen and many regional carriers and some larger
carriers do not provide this service. Those carriers that do allow
passengers to use the medical oxygen typically provide the compressed
oxygen themselves and charge a fee for this service.
Over the last two years, a new portability technology for
dispensing medical oxygen to users has been brought to the FAA's
attention-- (1) the AirSep Corporation's LifeStyle Portable Oxygen
Concentrator (POC), which is the first unit to be evaluated by the FAA;
and (2) the Inogen, Inc.'s Inogen One POC, which is currently being
evaluated by the FAA. The FAA has reviewed the documentation on both
these products and had several discussions with their manufacturers
regarding the use of these units on board aircraft. Based on
information received to date, the FAA believes that the AirSep POC unit
warrants special consideration for use on aircraft. The FAA currently
is reviewing the Inogen One POC to determine if it too warrants such
special consideration. Therefore, this proposed rule only pertains to
the AirSep POC.
[[Page 42325]]
The AirSep POC, which does not contain hazardous materials,
operates by separating oxygen from nitrogen and other gases comprising
ambient air and dispensing it in concentrated form to the user at a
purity level of approximately 90% (3%). The AirSep units
deliver five oxygen flow rates of 1 to 5 liters per minute. The AirSep
units must have their filters changed by an authorized equipment
distributor every 3000 hours. There is an hour meter on the device that
notifies the user how many hours have gone by since the last
maintenance check. The AirSep units may be operated either from an
aircraft electrical outlet (if installed) or by a rechargeable battery
with a duration of 50 minutes fully charged.
RSPA has reviewed and evaluated both the AirSep POC and the Inogen
POC and determined that these devices are not regulated as hazardous
materials in transportation. RSPA issued letters to the manufacturers
stating this conclusion in May 2003 (AirSep POC) and March 2004 (Inogen
POC).
While the RSPA determination is an important step for the FAA's
review of the POCs, the FAA must still make an independent
determination whether the devices pose a hazard in aviation. If there
is no hazard, then the FAA could grant an exemption to petitioners from
either Sec. 121.574, 125.219, or 135.91, as applicable, allowing the
use of the POCs because the FAA's regulations apply to devices that
dispense oxygen. The FAA informed the portable oxygen community that an
exemption would be needed in order for a passenger to carry on and
operate a POC not furnished by the aircraft operator via a letter
issued through the Department of Transportation's Office of the
Secretary in November 2002. To date, the FAA has not yet received any
petitions for exemption. The FAA has been informed that several air
carriers are interested in this technology and are in the process of
evaluating whether these devices interfere with the electrical,
navigation or communication equipment on board its aircraft. Rather
than waiting for a carrier to apply to the FAA for an exemption under
the existing regulatory structure, the FAA has decided to propose an
amendment to its regulations to permit passengers to carry on and
operate their own POC on board an aircraft as long as certain
conditions are met.
Section-by-Section Discussion of the Proposals
Section 1 of the SFAR would indicate that this SFAR prescribes
special operating rules for the AirSep POC. It also establishes that
the SFAR would apply to both the aircraft operator and the passenger
using the POC. Section 2 would then define the AirSep POC.
Section 3 would establish the requirements for operating this
device on board an aircraft. Section 3(a)(1) specifies that the
aircraft operator is responsible for determining whether the device
would interfere with the electrical, navigation or communication
equipment aboard each aircraft on which the device is used. The
operator is responsible for making this determination pursuant to 14
CFR 91.21, 121.306, 125.204, or 135.144. Given the broad array of
aircraft and equipment combinations, only the operator can be
responsible for making such a determination.
Section 3(a)(2) would mirror a safety warning contained in the
AirSep Patient User Manual. In this Manual, AirSep states that leaving
the nasal cannula under bed coverings or chair cushions while the POC
is turned on but not in use could result in the oxygen ``mak[ing] the
material flammable.'' However, the FAA has also been informed by AirSep
that if the nasal cannula is not positioned to sense inhalation, no
oxygen will flow from the cannula. The FAA seeks comments regarding
risks associated with the POC being turned on but not in use.
Section 3(a)(3) would require the operator to assure that the user
is capable of hearing the unit's various alarms, seeing the alarm light
indicators, and taking the appropriate action in response to the alarm,
or travel with someone who is capable of performing those functions.
This proposed condition also mirrors several warning statements in the
AirSep Patient User Manual. The POC is equipped with an alarm that will
sound in the event that the unit fails to sense user breathing,
overheats, or otherwise malfunctions. Section 3(b)(1) requires that the
operator assure that the user turns off the unit in the event that the
alarm sounds indicating a general malfunction of the unit while in use
on the aircraft.
Section 3(a)(4) would prohibit the operator from allowing smoking
or open flame within 10 feet of any person using a POC. The FAA's
regulations at Sec. 121.574, 125.219, and 135.91 require no less than
10 feet between a person smoking and a passenger using oxygen. Given
the unique environment of an aircraft, and the devastating consequences
that can occur in the event oxygen is used too close to someone who is
smoking, the FAA is proposing a limit of at least 10 feet. While
smoking is no longer allowed on scheduled flights, it may be permitted
on non-scheduled flights.
Section 3(a)(5) requires that the operator prevent the air intake/
gross particle filter and air outlet from being blocked while in use.
The FAA believes it is important to include this statement in its
conditions because blocking off the filter or outlet could result in
the unit malfunctioning and having to be turned off.
Section 3(a)(6) and (7) would require that the device be stowed
either underneath the seat in front of the user, or in another approved
stowage location, and that the user is seated, so as not to restrict
access to or use of any required emergency, or regular exit or of the
aisle in the passenger compartment. These two conditions are consistent
with the FAA's existing regulations and are necessary to ensure safe
movement within the cabin, prevent injury from loose objects within the
cabin and, if necessary, not obstruct evacuation of the aircraft.
Section 3(a)(8) would require the operator to ensure that the
device is free from oil, grease or petroleum products. Again this
condition is similar to a warning statement contained in the AirSep
Patient User Manual and to a condition contained in the FAA's current
medical oxygen regulations. This condition also obligates the operator
to look at the condition of the device and ensure that it is free from
damage and other signs of excessive wear or abuse. Section 3(a)(9)
would require the operator to verify that the hour meter indicates that
the hours will not exceed 3000 hours by the end of the scheduled flight
time of that flight leg. Section 3(a)(10) would require the pilot in
command to be notified when a passenger is using the portable oxygen
concentrator on board the aircraft. This is consistent with current
Sec. Sec. 121.574, 125.219, and 135.91, and ensures that the pilot in
command (PIC) is fully informed.
Section 3(b) would impose certain standards and requirements on the
unit's user. Section 3(b)(1) would require the user to be capable of
hearing the unit's alarms, seeing the alarm light indicators, and
taking the appropriate action in response to the various alarms and
alarm light indicators, or be traveling with someone who is capable of
hearing the unit's alarms, seeing the alarm light indicators, and
taking the appropriate action in response to the various alarms and
alarm light indicators.
Section 3(b)(2) would obligate the user to turn off the unit if a
warning alarm and associated alarm light indicator detects a general
malfunction of the unit. However, FAA has received information from
AirSep that a warning
[[Page 42326]]
alarm will sound if the gross particle filter or air outlet is blocked.
According to AirSep, once the blockage is removed the alarm sound will
stop and the unit does not need to be turned off. The FAA is seeking
comments as to the various reasons an alarm may sound and how these
situations can be remedied.
Section 3(b)(3) would mandate that the user must have a statement
signed by a licensed physician that specifies the use of the POC and
establishes the maximum flow rate corresponding to the pressure in the
cabin of the aircraft under normal operating conditions.
Section 3(b)(4) would mirror the AirSep Patient User Manual by
requiring that the user only use lotions or salves that are approved
for use with oxygen.
Section 3(b)(5) stipulates that the user must ascertain from the
aircraft operator the duration of the flight (including any anticipated
delays) and provide a sufficient number of batteries to power the
device for the duration of the flight, including reasonable delays.
This proposal is not intended to require that the AirSep portable
oxygen concentrator be powered by batteries as a condition of carriage.
Rather, this portion of the NPRM proposes that a user have a sufficient
number of batteries to potentially serve as a power source during all
phases of flight. This condition is consistent with the means for
determining the oxygen quantity needed for the duration of a flight
contained in 14 CFR 121.574(a)(5).
The FAA seeks comments on the following questions. First, should
the aircraft operator be required to inform the user about the
availability of electrical outlets suitable for the AirSep portable
oxygen concentrator? Second, 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? Third, are the
meanings of the terms ``anticipated delay'' and ``reasonable delay''
sufficiently clear? In a related Office of the Secretary rulemaking
under the Air Carrier Access Act, the Department will seek comment on
whether carriers must permit users of AirSep portable oxygen
concentrator to plug their devices into available on-board power
outlets, consistent with FAA safety rules related to electronic
devices.
Paperwork Reduction Act
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3507(d)), there are no requirements for information collection
associated with this proposal.
Summary of Economic Evaluation, Regulatory Flexibility Determination,
International Trade Impact Assessment and Unfunded Mandates Assessment
Changes to Federal regulations must undergo several economic
analyses. First, Executive Order 12866 directs that each Federal agency
shall propose or adopt a regulation only upon a reasoned determination
that the benefits of the intended regulation justify its costs. Second,
the Regulatory Flexibility Act of 1980 requires agencies to analyze the
economic impact of regulatory changes on small entities. Third, the
Trade Agreements Act (19 U.S.C. section 2531-2533) prohibits agencies
from setting standards that create unnecessary obstacles to the foreign
commerce of the United States. In developing U.S. standards, this Trade
Act requires agencies to consider international standards and, where
appropriate, that they be the basis of U.S. standards. And fourth, the
Unfunded Mandates Reform Act of 1995 requires agencies to prepare a
written assessment of costs, benefits and other effects of proposed or
final rules that include a Federal mandate likely to result in the
expenditure by State, local or tribal governments, in the aggregate, or
by the private sector, of $100 million or more, in any one year
(adjusted for inflation).
However, for regulations with an expected minimal impact the above-
specified regulatory evaluation is not required. The Department of
Transportation Order DOT 2100.5 prescribes policies and procedures for
simplification, analysis and review of regulations. If it is determined
that the expected economic impact is so minimal that the proposal does
not warrant a full evaluation, a statement to that effect and the basis
for it is included in the proposed regulation.
This proposed SFAR would permit the use of certain portable oxygen
concentrator (POC) devices on aircraft, provided certain conditions are
satisfied. These conditions are described elsewhere in this document
and would impose some costs on aircraft operators who choose to allow
FAA approved POCs on board their aircraft. This proposal does not
require operators to allow their use, however, and therefore it imposes
no costs. The FAA assumes that operators who choose to allow POC use
would voluntarily decide to take this action only if it were
advantageous for them to do so. Since this proposal imposes no required
costs, no economic evaluation was proposed.
Regulatory Flexibility Determination
The Regulatory Flexibility Act of 1980 (RFA) establishes ``as a
principle of regulatory issuance that agencies shall endeavor,
consistent with the objective of the rule and of applicable statutes,
to fit regulatory and informational requirements to the scale of the
business, organizations, and governmental jurisdictions subject to the
regulation.'' To achieve that principle, the Act requires agencies to
solicit and consider flexible regulatory proposals and to explain the
rationale for their actions. The Act covers a wide range of small
entities, including small businesses, not-for-profit organizations and
small governmental jurisdictions.
Agencies must perform a review to determine whether a proposed or
final rule will have a significant economic impact on a substantial
number of small entities. If the determination is that it will, the
agency must prepare a regulatory flexibility analysis as described in
the Act. However, if an agency determines that a proposed or final rule
is not expected to have a significant economic impact on a substantial
number of small entities, section 605(b) of the 1980 act provides that
the head of the agency may so certify and a regulatory flexibility
analysis is not required. The certification must include a statement
providing the factual basis for this determination, and the reasoning
should be clear.
Since meeting the requirements of this proposed SFAR is entirely
voluntary on the part of the aircraft operators, it imposes no economic
burden. Consequently, the FAA certifies that the rule would not have a
significant economic impact on a substantial number of small entities.
International Trade Impact Analysis
The Trade Agreement Act of 1979 prohibits Federal agencies from
engaging in any standards or related activities that create any
unnecessary obstacles to the foreign commerce of the United States.
Legitimate domestic objectives, such as safety, are not considered
unnecessary obstacles. The statute also requires consideration of
international standards and where appropriate, that they be the basis
for U.S. standards. In addition, consistent with the Administration's
belief in the general superiority and desirability of free trade, it is
the policy of the Administration to remove or diminish to the extent
feasible, barriers to international trade, including both barriers
affecting the export of American goods and services to foreign
countries
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and barriers affecting the import of foreign goods and services to the
United States.
In accordance with the above statute and policy, the FAA has
assessed the potential effect of this proposed SFAR to be minimal and
therefore has determined that this proposal will not result in an
impact on international trade by companies doing business in or with
the United States.
Unfunded Mandates Reform Act
The Unfunded Mandates Reform Act of 1995 (the Act) is intended,
among other things, to curb the practice of imposing unfunded Federal
mandates on State, local, and tribal governments. Title II of the Act
requires each Federal agency to prepare a written statement assessing
the effects of any Federal mandate in a proposed or final agency rule
that may result in an expenditure of $100 million or more (adjusted
annually for inflation) in any one year by State, local, and tribal
governments, in the aggregate, or by the private sector; such a mandate
is deemed to be a ``significant regulatory action.'' The FAA currently
uses an inflation-adjusted value of $120.7 million in lieu of $100
million.
This proposed SFAR does not contain such a mandate. Therefore, the
requirements of Title II of the Unfunded Mandates Reform Act of 1995 do
not apply.
Executive Order 13132, Federalism
FAA analyzed this proposed rule under the principles and criteria
of Executive Order 13132, Federalism. It determined that this action
would not have a substantial direct effect on the States, on the
relationship between the national Government and the States, or on the
distribution of power and responsibilities among the various levels of
government. Therefore, FAA has concluded that this notice of proposed
rulemaking does not have federalism implications.
Energy Impact
The energy impact of the proposed rule has been assessed in
accordance with the Energy Policy and Conservation Act (EPCA), Public
Law 94-163, as amended (42 U.S.C. 6362). FAA has determined that the
proposed rule is not a major regulatory action under the provisions of
the EPCA.
List of Subjects in 14 CFR Parts 121, 125, and 135
Air carriers, Aircraft, Airmen, Aviation safety, Charter flights,
Safety, Transportation, Air taxis.
The Proposed Amendment
In consideration of the foregoing, the Federal Aviation
Administration proposes to add SFAR No.-------- to Chapter II of Title
14, Code of Federal Regulations, as follows:
1. The authority citation for this SFAR shall read as follows:
Authority: 49 U.S.C. 106(g), 1153, 40101, 40102, 40103, 40113,
41721, 44105, 44106, 44111, 44701-44717, 44722, 44901, 44903, 44904,
44906, 44912, 44914, 44936, 44938, 46103, 46105.
2. Special Federal Aviation Regulation No. XX is added to read as
follows:
Special Federal Aviation Regulation No. XX Rules for Use of Portable
Oxygen Concentrator Systems on Board Aircraft
Section 1. Applicability--This rule prescribes special operating
rules for the use of portable oxygen concentrator units on board civil
aircraft. This rule applies to both the aircraft operator and the
passenger using the portable oxygen concentrator on board the aircraft.
Section 2. Definitions--For the purposes of this SFAR the following
definitions apply: AirSep LifeStyle Portable Oxygen Concentrator units
are medical devices that: (1) Do not contain hazardous materials as
determined by the Research and Special Programs Administration; (2) are
regulated by the Food and Drug Administration; (3) provide oxygen
therapy through pulse technology; and (4) assists a user of medical
oxygen under a doctor's care. These units perform by separating oxygen
from nitrogen and other gases comprising ambient air and dispenses it
in concentrated form to the user.
Section 3. Operating requirements--(a) The AirSep LifeStyle
Portable Oxygen Concentrator unit may be used by a passenger on board
an aircraft provided the operator ensures that the following conditions
are satisfied:
(1) The device does not cause interference with the electrical,
navigation or communication equipment on the aircraft on which the
device is to be used;
(2) The unit must be turned off if the nasal cannula is not
positioned for oxygen delivery to the user;
(3) The user must be capable of seeing the alarm indicator lights,
hearing the various warning alarms, and taking the appropriate action
should the unit fail to detect the user's breathing or a general
malfunction occurs, or is traveling with someone who is capable of
performing those functions for the user;
(4) No smoking or open flame is permitted within 10 feet of any
person using a portable oxygen concentrator;
(5) The air intake/gross particle filter or the air outlet must not
be blocked during use;
(6) The unit must either be stowed under the seat in front of the
user, or in another approved stowage location, so that it does not
block the aisle way or the entryway into the row;
(7) No person using a portable oxygen concentrator is permitted to
be seated in an exit row;
(8) The portable oxygen concentrator must be free from oil, grease
or other petroleum products and be in good condition free from damage
or other signs of excessive wear or abuse;
(9) The number of hours before maintenance must be below 3,000 at
the end of the scheduled flight time for that flight leg; and
(10) The pilot in command must be apprised when a passenger is
using a portable oxygen concentrator.
(b) The user of the portable oxygen concentrator must comply with
the following conditions to use the device on board the aircraft:
(1) The user must be capable of hearing the unit's alarms, seeing
the alarm light indicators, and taking the appropriate action in
response to the various alarms and alarm light indicators, or be
traveling with someone who is capable of performing those functions;
(2) In the event the warning alarm sounds, the portable oxygen
concentrator unit must be turned off if the warning alarm and the
associated alarm light indicator detects a general malfunction of the
unit;
(3) The passenger must have a statement signed by a licensed
physician that specifies the use of the portable oxygen concentrator
and establishes the maximum flow rate corresponding to the pressure in
the cabin of the aircraft under normal operating conditions;
(4) Only lotions or salves that are oxygen approved may be used by
persons using the portable oxygen device; and
(5) The user must obtain from the aircraft operator the duration of
the planned flight, including any anticipated delays. The user must
provide a sufficient number of batteries to power the device for the
duration of the flight, including any reasonable delays.
Issued in Washington, DC, on July 8, 2004.
James W. Whitlow,
Deputy Chief Counsel.
[FR Doc. 04-15969 Filed 7-13-04; 8:45 am]
BILLING CODE 4910-13-P