Explanatory Statement
Civil Aviation Safety Regulations 1998
Exemption — materials flammability airworthiness standards for Medical Isolation Transportation Devices
Legislation
Section 98 of the Civil Aviation Act 1988 (the Act) empowers the Governor-General to make regulations for the safety of air navigation.
Regulation 201.001 of the Civil Aviation Safety Regulations 1998 (CASR 1998) allows CASA to appoint a person to be an authorised person for a provision of CASR 1998 if CASA is satisfied that the person has the qualifications and experience to be an authorised person.
Regulation 21.243 of CASR 1998 requires CASA to approve an applicant as an approved design organisation if the criteria set out in regulation 21.243 are met. These criteria prescribe, among other matters, the requirements for the applicant’s design assurance system and proposed exposition.
Division 21.M.2 of CASR 1998 deals with modification/repair design approvals for an aircraft, aircraft engine, propeller or appliance. Under regulation 21.437 of CASR 1998, an applicant for a modification/repair design approval may apply to have that approval granted by an authorised person or an approved design organisation. Before the approval is granted, the authorised person or approved design organisation must be satisfied that, among other things, the design complies with the applicable airworthiness standards for the design.
Subregulation 11.160 (1) of CASR 1998 provides that, for subsection 98 (5A) of the Act, CASA may grant an exemption from a provision of the Civil Aviation Orders. Under subregulation 11.160 (2), an exemption may be granted to a person, or to a class of persons, and may specify the class by reference to membership of a specified body or any other characteristic.
Under subregulation 11.205 (1) of CASR 1998, CASA may impose conditions on an exemption if this is necessary in the interests of the safety of air navigation. Under regulation 11.225 of CASR 1998, an exemption must be published on the Internet. Under subregulation 11.230 (1), an exemption ceases on the day specified within it (but no longer than 3 years after its commencement) or, if no day is specified, 3 years after commencement.
Instrument
CASA EX109/16 continues a former exemption, CASA EX153/14. GVH Aerospace Pty Ltd (who formerly traded as Aeronautical Engineers Australia) previously submitted a safety case to CASA concerning the design of the ISOPOD, a Medical Isolation Transportation Device (MITD) that allows the carriage of a patient in an aircraft where the patient needs to be isolated from other aircraft occupants. The ISOPOD has failed materials flammability requirements contained in applicable airworthiness standards. Modification of the design to comply with flammability requirements is not possible due to its primary function of containing an infectious or contaminated patient for transport.
CASA assessed the safety case and considered it appropriate to issue an exemption, applicable to all authorised persons and approved design organisations for the purposes of regulation 21.437 of CASR 1998, which allows an authorised person, or an approved design organisation, to disregard materials flammability requirements before issuing a design approval for an MITD. An authorised person, or an approved design organisation, must still be satisfied with regard to other applicable airworthiness standards for the MITD.
CASA notes that an MITD will be infrequently used on aircraft, that the MITD is not in itself an ignition source, and that risk mitigation measures can be implemented to increase the level of safety in an aircraft installed with an MITD. Accordingly, the exemption is subject to a range of conditions imposing such risk mitigation measures in the interests of aviation safety. These conditions include a requirement for the approved flight manual supplement for an aircraft installed with an MITD to include a notice to crew that the MITD does not meet cabin interior materials flammability requirements. The MITD must also be placarded with a statement that declares that the MITD does not meet cabin interior materials flammability requirements. In addition, at least 1 fire extinguisher must be easily accessible to occupants of the aircraft cabin.
The exemption contains a savings provision that ensures any modification/repair design approval issued by an authorised person, or an approved design organisation, in accordance with the exemption will continue to have effect after expiry of the exemption.
Legislation Act 2003 (the LA)
Paragraph 98 (5A) (a) of the Act provides that CASA may issue instruments in relation to matters affecting the safe navigation and operation or the maintenance of aircraft.
An exemption issued under regulation 11.160 of CASR 1998 is issued under subsection 98 (5A) of the Act. Subsection 98 (5AA) of the Act states that an instrument issued under paragraph (5A) (a) is a legislative instrument if it applies to a class of persons or a class of aircraft.
This exemption applies to 3 classes of persons, being authorised persons, approved design organisations, and applicants for design approval. The exemption, being a legislative instrument, is subject to tabling and disallowance in the Parliament under sections 38 and 42 of the LA.
Consultation
This instrument continues the exemption previously provided by instrument CASA EX153/14, which expired at the end of November 2015.
The issue of CASA EX153/14 followed consultation with the aviation industry on the airworthiness requirements for MITDs. The operation of the exemption provided under instrument CASA EX153/14 was satisfactory, and the safety case and policy supporting the exemption under that instrument remains unchanged. In addition, there have been no substantial changes to the effect of the exemption provided under this instrument.
Having regard to these circumstances, it is CASA’s view that it is not necessary or appropriate to undertake any further consultation under section 17 of the LA.
Office of Best Practice Regulation (OBPR)
A Regulation Impact Statement (RIS) is not required because the instrument is covered by a standing agreement between CASA and OBPR under which a RIS is not required for exemptions (OBPR id: 14507).
Statement of Compatibility with Human Rights
A Statement of Compatibility with Human Rights is at Attachment 1.
Making and commencement
The exemption has been issued by a delegate of CASA relying on the power of delegation under subregulation 11.260 (1) of CASR 1998.
The exemption commences on the day of registration and is repealed at the end of 30 June 2019.
[Instrument number CASA EX109/16]
Attachment 1
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the
Human Rights (Parliamentary Scrutiny) Act 2011
Exemption — materials flammability airworthiness standards for
Medical Isolation Transportation Devices
This legislative instrument is compatible with the human rights and freedoms
recognised or declared in the international instruments listed in section 3 of the
Human Rights (Parliamentary Scrutiny) Act 2011.
Overview of the legislative instrument
This legislative instrument exempts an authorised person, or an approved design organisation, from the requirement to be satisfied that the design for a Medical Isolation Transportation Device (MITD) meets materials flammability airworthiness standards. The exemption, therefore, allows an MITD to be installed on aircraft without meeting the same level of safety for materials flammability.
The exemption is subject to conditions that CASA considers necessary in the interests of aviation safety.
Human rights implications
This legislative instrument does not engage any of the applicable rights or freedoms.
Conclusion
This legislative instrument is compatible with human rights as it does not raise any human rights issues.
Civil Aviation Safety Authority