CASA EX153/14 - Exemption — materials flammability airworthiness standards for Medical Isolation Transportation Devices

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Legislation au F2014L01516 Not in force Legislative Instrument

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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, including 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.

 

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

Aeronautical Engineers Australia (AEA) has submitted a safety case to CASA concerning the design of the ISOPOD, a Medical Isolation Transportation Device (MITD) that allows a 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 has assessed the safety case and is issuing this 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 considers that an MITD will be infrequently used on aircraft, that it is not 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, including that the approved flight manual supplement for an aircraft installed with an MITD must include a notice to crew that the MITD does not meet cabin interior materials flammability requirements, and that at least 1 fire extinguisher must be easily accessible to the aircraft cabin. The MITD must also be placarded with a statement that declares that the MITD does not meet cabin interior materials flammability requirements.

 

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.

 

Legislative Instruments Act

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 Legislative Instruments Act 2003 (the LIA).

 

Consultation

CASA is issuing this exemption after consultation with industry on the airworthiness requirements for MITDs. Given the current spread of the Ebola virus, there is a pressing need for this exemption to allow MITD to be carried on aircraft, despite not meeting flammability requirements. It is CASA’s view that it is not necessary or appropriate to undertake any further consultation under section 17 of the LIA.

 

Statement of Compatibility with Human Rights

A Statement of Compatibility with Human Rights is at Attachment 1.

 

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 (OBPR id: 14507).

 

Making and commencement

The exemption has been issued by the Acting Director of Aviation Safety, on behalf of CASA, in accordance with subsection 73 (2) of the Act.

 

The exemption commences on the day of registration and expires at the end of November 2015, as if it had been repealed by another instrument.

 

[Instrument number CASA EX153/14]

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

Overview

The Civil Aviation Safety Regulations 1998 (CASR 1998) were enacted to ensure the safety of air navigation, providing a comprehensive framework for regulating the design, maintenance, and operation of aircraft and associated activities. In addressing the specific problem of transporting patients in medical isolation, the Civil Aviation Safety Authority (CASA) issued an exemption to the materials flammability airworthiness standards for Medical Isolation Transportation Devices (MITD). This exemption was introduced to accommodate the urgent need to transport patients with infectious diseases, such as Ebola, while acknowledging that modifying the design of MITDs to meet flammability standards is impractical due to their primary function. The exemption was issued under the authority granted by section 98 of the Civil Aviation Act 1988, empowering CASA to make regulations for air navigation safety. The policy objective of this exemption was to balance the necessity of transporting patients in isolation with the imperative to maintain the highest possible safety standards in air navigation.

Scope and Application

The Civil Aviation Safety Regulations 1998 (CASR 1998) exemption concerning materials flammability airworthiness standards for Medical Isolation Transportation Devices (MITD) applies to authorised persons and approved design organisations under regulation 21.437 of CASR 1998. This exemption, issued by the Civil Aviation Safety Authority (CASA) after consultation with industry, allows these entities to disregard the flammability requirements for MITDs while still ensuring compliance with other applicable airworthiness standards. The exemption is specifically tailored to the ISOPOD, a MITD designed for transporting patients who require isolation from other aircraft occupants, acknowledging that modifying the design to meet flammability standards is not feasible due to its primary function. The exemption is subject to conditions aimed at mitigating safety risks, such as requiring the aircraft's flight manual supplement to include a notice about the MITD's non-compliance with flammability standards and mandating the presence of at least one easily accessible fire extinguisher in the aircraft cabin. Furthermore, the MITD itself must be placarded with a declaration of its non-compliance with flammability standards. The exemption is applicable nationally and is considered a legislative instrument under the Legislative Instruments Act 2003, subject to tabling and disallowance in the Parliament. It is compatible with human rights as it does not engage any of the rights or freedoms recognised in the Human Rights (Parliamentary Scrutiny) Act 2011. The exemption commences on the day of its registration and is set to expire at the end of November 2015, as if it had been repealed by another instrument. This measure is a response to the pressing need for MITDs in the context of infectious disease transport, particularly during the spread of diseases like Ebola, balancing the necessity for such devices with the imperative to maintain the highest possible safety standards in air navigation.

Key Provisions

The Civil Aviation Safety Regulations 1998 (CASR 1998) have been amended by this exemption, which primarily concerns the materials flammability airworthiness standards for Medical Isolation Transportation Devices (MITD). Regulation 21.437 of CASR 1998, which previously required compliance with materials flammability standards, is now subject to an exemption (CASR 1998, subreg. 11.160(1)). This means that authorised persons and approved design organisations can disregard these flammability requirements when issuing design approvals for MITDs, provided other airworthiness standards are still met (CASR 1998, reg. 21.437). The exemption is in place to allow the carriage of patients who need to be isolated on aircraft, despite the MITD not meeting materials flammability standards due to its function (CASA EX153/14). The obligations under this exemption require authorised persons and approved design organisations to ensure that any MITD design approval issued under the exemption includes specific conditions to mitigate safety risks. These conditions include ensuring the approved flight manual supplement for an aircraft installed with an MITD must include a notice to crew about the MITD's non-compliance with materials flammability standards, and that at least one fire extinguisher is easily accessible in the aircraft cabin (CASA EX153/14). Additionally, the MITD must be placarded with a statement declaring that it does not meet the cabin interior materials flammability requirements. Failure to comply with the conditions of this exemption could result in legal consequences. Although specific penalties for non-compliance are not detailed in the exemption, general provisions under CASR 1998 may apply. Violations of airworthiness standards or non-compliance with CASA's conditions can lead to enforcement actions, including fines or other regulatory measures (CASR 1998, reg. 91.211). The exemption itself is subject to tabling and disallowance in Parliament under the Legislative Instruments Act 2003, ensuring it is subject to parliamentary scrutiny (LIA, ss. 38 and 42). The exemption does not impose new offences or penalties but operates under existing legal frameworks for airworthiness and compliance with CASA's regulations. The Civil Aviation Act 1988 and CASR 1998 provide the basis for enforcement actions and penalties for non-compliance with aviation safety regulations. The exemption is issued in response to the urgent need to transport patients in isolation, particularly in light of the spread of infectious diseases such as Ebola, ensuring that the risk is managed through specified safety measures.

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