Document ID: FAA-2023-0068-0001
Agency: faa
Document Type: Rule
Title: Special Conditions: B/E Aerospace Ltd., MHI RJ Aviation ULC Model CL-600-2B19 Airplane; Installation of a Therapeutic Oxygen System for Medical Use
Posted Date: 2023-05-24T04:00Z

[Federal Register Volume 88, Number 100 (Wednesday, May 24, 2023)]
[Rules and Regulations]
[Pages 33548-33550]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-10987]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 25

[Docket No. FAA-2023-0068; Special Conditions No. 25-821-SC]

Special Conditions: B/E Aerospace Ltd., MHI RJ Aviation ULC Model 
CL-600-2B19 Airplane; Installation of a Therapeutic Oxygen System for 
Medical Use

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final special conditions; request for comments.

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SUMMARY: These special conditions are issued for the MHI RJ Aviation 
ULC Model CL-600-2B19 airplane. This airplane, as modified by B/E 
Aerospace Ltd. (B/E Aerospace), will have a novel or unusual design 
feature when compared to the state of technology envisioned in the 
airworthiness standards for transport-category airplanes. This design 
feature is an installation of a therapeutic oxygen system for medical 
use. The applicable airworthiness regulations do not contain adequate 
or appropriate safety standards for this design feature. These special 
conditions contain the additional safety standards that the 
Administrator considers necessary to establish a level of safety 
equivalent to that established by the existing airworthiness standards.

DATES: This action is effective on B/E Aerospace Ltd. on May 24, 2023. 
Send comments on or before July 10, 2023.

ADDRESSES: Send comments identified by Docket No. FAA-2023-0068 using 
any of the following methods:
     Federal eRegulations Portal: Go to https://www.regulations.gov/ and follow the online instructions for sending 
your comments electronically.
     Mail: Send comments to Docket Operations, M-30, U.S. 
Department of Transportation (DOT), 1200 New Jersey Avenue SE, Room 
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket 
Operations in Room W12-140 of the West Building Ground Floor at 1200 
New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday 
through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at 202-493-2251.
    Docket: Background documents or comments received may be read at 
https://www.regulations.gov/ at any time. Follow the online 
instructions for accessing the docket or go to Docket Operations in 
Room W12-140 of the West Building Ground Floor at 1200 New Jersey 
Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday through 
Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Robert Hettman, Mechanical Systems, 
AIR-623, Technical Policy Branch, Policy and Standards Division, 
Aircraft Certification Service, Federal Aviation Administration, 2200 
South 216th Street, Des Moines, Washington 98198; telephone and fax 
206-231-3171; email [email protected].

SUPPLEMENTARY INFORMATION: The substance of these special conditions 
has been published in the Federal Register for public comment in 
several prior instances with no substantive comments received. 
Therefore, the FAA finds, pursuant to Sec.  11.38(b), that new comments 
are unlikely, and notice and comment prior to this publication are 
unnecessary.

Comments Invited

    The FAA invites interested people to take part in this rulemaking 
by sending written comments, data, or views. The most helpful comments 
reference a specific portion of the special conditions, explain the 
reason for any recommended change, and include supporting data.
    The FAA will consider all comments received by the closing date for 
comments, and will consider comments filed late if it is possible to do 
so

[[Page 33549]]

without incurring delay. The FAA may change these special conditions 
based on the comments received.

Privacy

    Except for Confidential Business Information (CBI) as described in 
the following paragraph, and other information as described in title 
14, Code of Federal Regulations (14 CFR) 11.35, the FAA will post all 
comments received without change to https://www.regulations.gov/, 
including any personal information you provide. The FAA will also post 
a report summarizing each substantive verbal contact received about 
these special conditions.

Confidential Business Information

    Confidential Business Information (CBI) is commercial or financial 
information that is both customarily and actually treated as private by 
its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), 
CBI is exempt from public disclosure. If your comments responsive to 
these special conditions contain commercial or financial information 
that is customarily treated as private, that you actually treat as 
private, and that is relevant or responsive to these special 
conditions, it is important that you clearly designate the submitted 
comments as CBI. Please mark each page of your submission containing 
CBI as ``PROPIN.'' The FAA will treat such marked submissions as 
confidential under the FOIA, and the indicated comments will not be 
placed in the public docket of these special conditions. Send 
submissions containing CBI to the individual listed in the For Further 
Information Contact section above. Comments the FAA receives, which are 
not specifically designated as CBI, will be placed in the public docket 
for these special conditions.

Background

    On November 17, 2022, B/E Aerospace applied for a supplemental type 
certificate for the modification of the oxygen distribution system on 
the MHI RJ Aviation ULC Model CL-600-2B19 airplane (type certificate 
previously held by Bombardier, Inc). This airplane, which is currently 
approved under Type Certificate A21EA-1, is a twin-engine transport 
category airplane with a maximum takeoff weight of 47,450 pounds. The 
Model CL-600-2B19 (Challenger 850 series) airplane has a seating 
capacity of 19 passengers.

Type Certification Basis

    Under the provisions of title 14, Code of Federal Regulations (14 
CFR) 21.101, B/E Aerospace must show that the MHI RJ Aviation ULC Model 
CL-600-2B19 airplane, as changed, continues to meet the applicable 
provisions of the regulations listed in Type Certificate No. A21EA-1 or 
the applicable regulations in effect on the date of application for the 
change, except for earlier amendments as agreed upon by the FAA.
    If the Administrator finds that the applicable airworthiness 
regulations (e.g., 14 CFR part 25) do not contain adequate or 
appropriate safety standards for the MHI RJ Aviation ULC Model CL-600-
2B19 airplane because of a novel or unusual design feature, special 
conditions are prescribed under the provisions of Sec.  21.16.
    Special conditions are initially applicable to the model for which 
they are issued. Should the applicant apply for a supplemental type 
certificate to modify any other model included on the same type 
certificate to incorporate the same novel or unusual design feature, 
these special conditions would also apply to the other model under 
Sec.  21.101.
    In addition to the applicable airworthiness regulations and special 
conditions, the MHI RJ Aviation ULC Model CL-600-2B19 airplane must 
comply with the fuel-vent and exhaust-emission requirements of 14 CFR 
part 34, and the noise-certification requirements of 14 CFR part 36.
    The FAA issues special conditions, as defined in Sec.  11.19, in 
accordance with Sec.  11.38, and they become part of the type 
certification basis under Sec.  21.101.

Novel or Unusual Design Features

    The MHI RJ Aviation ULC Model CL-600-2B19 airplane will incorporate 
the following novel or unusual design feature:
    A modification of the oxygen-distribution system that affects how 
the common source of oxygen supply on board is shared between the 
flightcrew and passengers to provide supplemental and therapeutic 
oxygen.

Discussion

    No specific regulations address the design and installation of 
required passenger oxygen systems that share a supply source with an 
optional oxygen system used specifically for therapeutic applications. 
Therapeutic oxygen systems have been previously certified, and were 
generally considered an extension of the passenger oxygen system for 
the purpose of defining the applicable regulations. As a result, 
existing requirements, such as Sec. Sec.  25.1309, 25.1441(b) and (c), 
25.1451, and 25.1453, in the MHI RJ Aviation ULC Model CL-600-2B19 
airplanes' certification basis applicable to this STC project, provide 
some design standards appropriate for oxygen system installations. In 
addition, Sec.  25.1445 includes standards for oxygen distribution 
systems when oxygen is supplied to flightcrew and passengers. If a 
common source of supply is used, Sec.  25.1445(a)(2) requires a means 
to separately reserve the minimum supply required by the flightcrew.
    Section 25.1445 is intended to protect the flightcrew by ensuring 
that an adequate supply of oxygen is available to complete a descent 
and landing following a loss of cabin pressure. When the regulation was 
written, the only passenger oxygen system designs were supplemental 
oxygen systems intended to protect passengers from hypoxia in the event 
of a decompression. Existing passenger oxygen systems did not include 
design features that would allow the flightcrew to control oxygen to 
passengers during flight. There are no similar requirements in Sec.  
25.1445 when oxygen is supplied from the same source to passengers for 
use during a decompression, and for discretionary or first-aid use any 
time during the flight. In the design, the passenger and therapeutic 
oxygen systems use the same source of oxygen. These special conditions 
contain additional design requirements for the equipment involved in 
this dual therapeutic oxygen plus gaseous oxygen installation.
    These special conditions contain the additional safety standards 
that the Administrator considers necessary to establish a level of 
safety equivalent to that established by the existing airworthiness 
standards.

Applicability

    As discussed above, these special conditions are applicable to the 
MHI RJ Aviation ULC Model CL-600-2B19 airplane. Should B/E Aerospace 
apply at a later date for a supplemental type certificate to modify any 
other model included on Type Certificate No. A21EA-1 to incorporate the 
same novel or unusual design feature, these special conditions would 
apply to that model as well.

Conclusion

    This action affects only a certain novel or unusual design feature 
on one model of airplane. It is not a rule of general applicability and 
affects only the applicant who applied to the FAA for approval of these 
features on the airplane.

[[Page 33550]]

List of Subjects in 14 CFR Part 25

    Aircraft, Aviation safety, Reporting and recordkeeping 
requirements.

Authority Citation

    The authority citation for these special conditions is as follows:

    Authority:  49 U.S.C. 106(f), 106(g), 40113, 44701, 44702, and 
44704.

The Special Conditions

    Accordingly, pursuant to the authority delegated to me by the 
Administrator, the following special conditions are issued as part of 
the type certification basis for MHI RJ Aviation ULC Model CL-600-2B19 
airplanes, as modified by B/E Aerospace Ltd.
    The distribution system for the passenger therapeutic oxygen system 
must be designed and installed to meet requirements as follows:
    When oxygen is supplied to passengers for both supplemental and 
therapeutic purposes, the distribution system must be designed for 
either--
    (1) A source of supplemental oxygen for protection following a loss 
of cabin pressure, and a separate source for therapeutic purposes; or
    (2) A common source of supply with means to separately reserve the 
minimum supply required by the passengers for supplemental use 
following a loss of cabin pressure.

    Issued in Kansas City, Missouri, on May 18, 2023.
Patrick R. Mullen,
Manager, Technical Policy Branch, Policy and Standards Division, 
Aircraft Certification Service.
[FR Doc. 2023-10987 Filed 5-23-23; 8:45 am]
BILLING CODE 4910-13-P