![[logo] US EPA](http://www.epa.gov/epafiles/images/logo_epaseal.gif){kind=logo}
Use of Additional Portable Oxygen Concentrator Devices Onboard Aircraft
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: September 12, 2006 (Volume 71, Number 176)]
[Rules and Regulations]
[Page 53953-53956]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12se06-16]
[[Page 53954]]
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 121
[Docket No. FAA-2004-18596; SFAR 106]
RIN 2120-AI81
Use of Additional Portable Oxygen Concentrator Devices Onboard Aircraft
AGENCY: Federal Aviation Administration (FAA), DOT.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This action amends Special Federal Aviation Regulation 106
(SFAR 106), Use of Certain Portable Oxygen Concentrator Devices Onboard
Aircraft, to allow for the use of the AirSep Corporation's FreeStyle,
SeQual Technologies' Eclipse, and Respironics Inc.'s EverGo portable
oxygen concentrator (POC) devices onboard aircraft, provided certain
conditions in the SFAR are met. This action is necessary to allow all
POC devices deemed acceptable by the FAA to be available to the
traveling public in need of oxygen therapy for use in air commerce.
When this rule becomes effective, there will be a total of five
different POC devices the FAA finds acceptable for use onboard aircraft
during travel, and passengers will be able to carry these devices onboard
the aircraft and use them with the approval of the aircraft operator.
DATES: This final rule amending SFAR 106 will become effective on
September 12, 2006.
FOR FURTHER INFORMATION CONTACT: David Catey, Air Transportation
Division, Flight Standards Service, 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 FAA's Regulations and Policies Web page at
http://www.faa.gov/regulations_policies/; or
(3) Accessing the Government Printing Office's Web page at
http://www.gpoaccess.gov/fr/index.html.
You can also get a copy by sending 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.
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. Therefore, any small entity that has a question regarding
this document may contact their local FAA official, or the person
listed under FOR FURTHER INFORMATION CONTACT. You can find out more
about SBRFA on the Internet at our site,
http://www.faa.gov/regulations_policies/rulemaking/sbre_act/.
Authority for This Rulemaking
The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code (49 U.S.C.). Subtitle I,
Section 106 describes the authority of the FAA Administrator. Subtitle
VII, Aviation Programs, describes in more detail the scope of the
agency's authority.
The FAA is authorized to issue this final rule 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
On July 12, 2005, the FAA published Special Federal Aviation
Regulation 106 (SFAR 106) entitled, ``Use of Certain Portable Oxygen
Concentrator Devices Onboard Aircraft'' (70 FR 40156). SFAR 106 is the
result of a notice the FAA published in July 2004 (69 FR 42324) to
address the needs of passengers who must travel with medical oxygen.
Prior to publication of SFAR 106, passengers in need of medical oxygen
during air transportation faced many obstacles when requesting service.
Many carriers did not provide medical oxygen service aboard flights,
and those that did often provided service at a price that travelers
could not afford. Coordinating service between air carriers and
suppliers at airports was also difficult, and passengers frequently
chose not to fly because of these difficulties.
Recently, new medical oxygen technologies approved by the Food and
Drug Administration (FDA) reduce the risks typically associated with
compressed oxygen. Several manufacturers have developed small portable
oxygen concentrators (POC) that work by separating oxygen from nitrogen
and other gases contained in ambient air and dispensing it in
concentrated form to the user with an oxygen concentration of about
90%. The POCs operate using either rechargeable batteries or, if the
aircraft operator obtains approval from the FAA, aircraft electrical power.
In addition, the Pipeline and Hazardous Materials Safety
Administration (PHMSA) has determined that the POCs covered by this
amendment 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.
SFAR 106 permits passengers to carry on and use certain POCs
onboard aircraft if the aircraft operator ensures that the conditions
specified in the SFAR for their use are met. The devices initially
determined acceptable for use in SFAR 106 are the AirSep LifeStyle and
the Inogen One POCs. Aircraft operators can now offer medical oxygen
service as they did before SFAR 106 was enacted, or they can arrange
for passengers to carry on and use one of the devices covered in SFAR
106. SFAR 106 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 one of
these devices is allowed by the aircraft operator to be carried on
board, the conditions in the SFAR must be met.
When SFAR 106 was published, the FAA committed to establishing a
single standard for all POCs so that regulations wouldn't apply to
specific manufacturers and models of device. Whenever possible, the FAA
tries to regulate by creating standards rather than approving by
manufacturer. In the case of SFAR 106, the quickest and easiest way to
serve both the customer and the air carrier was to allow the use of the
devices determined to be acceptable by the FAA in SFAR 106 in a
special, temporary regulation. As we stated in the preamble discussion
in SFAR 106 ``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.'' We developed SFAR 106 and published it so that
passengers who otherwise could not fly could do so with an affordable
alternative to what existed before SFAR 106 was published.
We continue to pursue the performance-based standard for all POCs.
This process is time-consuming
[[Page 53955]]
and we intend to publish a notice in the Federal Register and offer the
public a chance to comment on the proposal when it is complete. In the
meantime, manufacturers continue to create new and better POCs, and
several have requested that their product also be included as an
acceptable device in SFAR 106. These new manufacturers include SeQual
Technologies, Inc., and Respironics, Inc. AirSep Corporation, which
manufactures the LifeStyle POC authorized for use under SFAR 106, has
asked the FAA to authorize the use of its FreeStyle POC under SFAR 106
also. Each of these companies has formally petitioned the FAA for
inclusion in SFAR 106 by submitting documentation of the devices to the
Department of Transportation's Docket Management System. That
documentation is available at http://dms.dot.gov under the following
docket numbers:
1. SeQual Technologies--FAA-2005-22574.
2. Respironics Inc., formerly OxyTec Medical Corporation--FAA-2006-
23678.
3. AirSep Corporation--FAA-2006-24912.
As stated in Section 2 of SFAR 106, each covered device must not
contain hazardous materials as determined by PHMSA (written
documentation necessary), and must also be regulated by the FDA. Each
petitioner included technical specifications for the devices in their
request for approval, along with the required documentation from PHMSA
and the FDA. The petitioners provided the FAA with the required
documentation for the following POC devices:
1. SeQual Technologies' Eclipse Oxygen System;
2. Respironics EverGo System; and
3. AirSep Corporation's FreeStyle Portable Oxygen Concentrator.
The Rule
This amendment to SFAR 106 will include the SeQual Eclipse,
Respironics EverGo, and AirSep FreeStyle devices in the list of POCs
authorized for use in air commerce. The FAA has reviewed each
individual device and accepted the documentation provided by the three
manufacturers. That documentation includes letters provided to the
manufacturer by PHMSA and the FDA affirming the status of each device
as it pertains to the requisites stated in SFAR 106.
After reviewing the applicable FDA safety standards and the PHMSA
findings, these three devices were determined by the FAA to be
acceptable for use in air commerce.
Along with the inclusion of these three new devices in Section 2 of
the SFAR, we amend the rule by removing the requirement that a POC
provide oxygen therapy solely through the use of pulse technology. It
was only after publication of SFAR 106 that we learned about a
continuous flow feature of the SeQual Technologies Eclipse POC. The
Eclipse POC features pulse delivery in addition to its continuous flow
feature. Therefore, we find there is no safety reason for limiting POC
acceptance to those POCs having only the pulse delivery feature. That
requirement was formerly included in Section 2 of the SFAR and has been
removed.
Good Cause for Adoption of This Final Rule Without Notice and Comment
As stated above, SFAR 106 was published on July 12, 2005. We stated
in the preamble of that final rule that the AirSep LifeStyle and Inogen
One POC devices were the only known acceptable devices when the rule
was published. We also stated in that final rule that ``we cannot
predict how future products may be developed and work.'' We initiated a
notice and comment period for the use of POC devices onboard aircraft
on July 14, 2004 (69 FR 42324) and responded to the comments received
in response to that NPRM in the final rule published in 2005.
Therefore, it is not in the public interest to publish a notice to
request comments on this amendment because all issues related to the
use of POC devices onboard an aircraft have already been discussed.
Further notice and comment would unnecessarily delay the acceptance of
the AirSep FreeStyle, SeQual Eclipse, and Respironics EverGo POC
devices as authorized for use onboard aircraft and included in SFAR 106.
Therefore, I find that notice and public comment under 5 U.S.C.
553(b) are impracticable and contrary to the public interest. Further,
I find that good cause exists for making this rule effective
immediately upon publication.
International Compatibility
In keeping with U.S. obligations under the Convention on
International Civil Aviation, it is FAA policy to comply with
International Civil Aviation Organization (ICAO) Standards and
Recommended Practices to the maximum extent practicable. The FAA
determined that there are no ICAO Standards and Recommended Practices
that correspond to these proposed regulations. I find that this action
is fully consistent with my obligations under 49 U.S.C. 40105(b)(1)(A)
to ensure that I exercise my duties consistently with the obligations
of the United States under international agreements.
Paperwork Reduction Act
As required by the Paperwork Reduction Act of 1995 (44 U.S.C.
3507(d)), the FAA submitted a copy of the new information collection
requirements in this final rule to the Office of Management and Budget
for its review. OMB approved the collection of this information and
assigned OMB Control Number 2120-0702.
This final rule requires that if a passenger carries a POC on board
the aircraft with the intent to use it during the flight, he or she
must inform the pilot in command of that flight. Additionally, the
passenger who plans to use the device must provide a written statement
signed by a licensed physician that verifies the passenger's ability to
operate the device, respond to any alarms, the extent to which the
passenger must use the POC (all or a portion of the flight), and
prescribes the maximum oxygen flow rate.
Please note that an agency may not conduct or sponsor, and a person
is not required to respond to, a collection of information unless it
displays a currently valid OMB control number. The Paperwork Reduction
Act paragraph in the final rule that established SFAR 106 still applies
to this amendment. The availability of three new POC devices will
likely increase the availability and options for a passenger in need of
oxygen therapy, but the paperwork burden discussed in the original
final rule is unchanged. Therefore, the OMB Control Number associated
with this collection remains 2120-0702.
Regulatory Analyses
Executive Order 12866 and DOT Regulatory Policies and Procedures
Executive Order 12866, Regulatory Planning and Review, directs the
FAA to assess both the costs and benefits of a regulatory change. We
are not allowed to propose or adopt a regulation unless we make a
reasoned determination that the benefits of the intended regulation
justify its costs. Our assessment of this proposal indicates that its
economic impact is minimal. Since its costs and benefits do not make it
a ``significant regulatory action'' as defined in the Order, we have
not prepared a ``regulatory impact analysis.'' Similarly, we have not
prepared a ``regulatory evaluation,'' which is the written cost/benefit
analysis ordinarily required for all rulemaking proposals under the DOT
[[Page 53956]]
Regulatory and Policies and Procedures. We do not need to do the latter
analysis where the economic impact of a proposal is minimal. This final
rule amending SFAR 106 has no new costs associated with it because
there is no requirement for use of these devices. The regulatory
evaluation presented when SFAR 106 was first published is still valid
and applicable, and the inclusion of these three devices as options for
passengers and operators does not change the cost or benefits assigned
in that final rule.
Regulatory Flexibility Determination
The Regulatory Flexibility Act of 1980 (RFA) directs the FAA to fit
regulatory requirements to the scale of the business, organizations,
and governmental jurisdictions subject to the regulation. We are
required to determine whether a proposed or final action will have a
``significant economic impact on a substantial number of small
entities'' as they are defined in the Act. If we find that the action
will have a significant impact, we must do a ``regulatory flexibility
analysis.''
This final rule adds three new devices to the list of authorized
POCs in SFAR 106. Its economic impact is minimal. Therefore, I certify
that this action will not have a significant economic impact on a
substantial number of small entities.
Trade Impact Assessment
The Trade Agreements Act of 1979 prohibits Federal agencies from
engaging in any standards or related activities that create 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 and barriers affecting the import of foreign goods and
services into the United States.
In accordance with the above statute and policy, the FAA has
assessed the potential effect of this final rule and has determined
that it will impose the same costs on domestic and international
entities and thus has a neutral trade impact.
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 $128.1 million in lieu of $100 million.
This final rule does not contain such a mandate. The requirements
of Title II of the Act, therefore, do not apply.
Executive Order 13132, Federalism
The FAA has analyzed this final rule under the principles and
criteria of Executive Order 13132, Federalism. We determined that this
action will not have a substantial direct effect on the States, or the
relationship between the national Government and the States, or on the
distribution of power and responsibilities among the various levels of
government. Therefore, we have determined that this final rule does not
have federalism implications.
Environmental Analysis
FAA Order 1050.1E identifies FAA actions that are categorically
excluded from preparation of an environmental assessment or
environmental impact statement under the National Environmental Policy
Act in the absence of extraordinary circumstances. The FAA has
determined this proposed rulemaking action qualifies for the
categorical exclusion identified in paragraph 312d and involves no
extraordinary circumstances.
Regulations That Significantly Affect Energy Supply, Distribution, or Use
The FAA has analyzed this final rule under Executive Order 13211,
Actions Concerning Regulations that Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 18, 2001). We have determined
that it is not a ``significant energy action'' under the executive
order because it is not a ``significant regulatory action'' under
Executive Order 12866, and it is not likely to have a significant
adverse effect on the supply, distribution, or use of energy.
List of Subjects in 14 CFR Part 121
Air carriers, Aircraft, Airmen, Aviation safety, Charter flights,
Safety, Transportation, Air taxis.
The Amendment
? In consideration of the foregoing, the Federal Aviation Administration
amends SFAR No. 106 to Chapter II of Title 14, Code of Federal
Regulations, as follows:
PART 121--OPERATING REQUIREMENTS: DOMESTIC, FLAG, AND SUPPLEMENTAL
OPERATIONS
? 1. The authority citation for part 121 continues to 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. Revise Section 2 of SFAR 106 to read as follows:
* * * * *
Section 2. Definitions--For the purposes of this SFAR the following
definitions apply: Portable Oxygen Concentrator: means the AirSep
LifeStyle, AirSep FreeStyle, Inogen One, SeQual Eclipse, or Respironics
EverGo Portable Oxygen Concentrator medical device units as long as
those medical device units: (1) Do not contain hazardous materials as
determined by the Pipeline and Hazardous Materials Safety
Administration; (2) are also regulated by the Food and Drug
Administration; and (3) assist a user of medical oxygen under a
doctor's care. These units perform by separating oxygen from nitrogen
and other gases contained in ambient air and dispensing it in
concentrated form to the user.
* * * * *
? 3. Revise Section 3(a) introductory text of SFAR 106 to read as follows:
Section 3. Operating Requirements--
(a) No person may use and no aircraft operator may allow the use of
any portable oxygen concentrator device, except the AirSep LifeStyle,
AirSep FreeStyle, Inogen One, SeQual Eclipse, or Respironics EverGo
Portable Oxygen Concentrator units. These units may be carried on and
used by a passenger on board an aircraft provided the aircraft operator
ensures that the following conditions are satisfied:
* * * * *
Issued in Washington, DC, on August 18, 2006.
Marion C. Blakey,
Administrator.
[FR Doc. 06-7597 Filed 9-11-06; 8:45 am]
BILLING CODE 4910-13-P