Explanatory Statement
Civil Aviation Safety Regulations 1998
CASA 69/18 – CASA 125/09 (Further Body Sample Collection Procedure – Quantisal Oral Fluid Collection Device) Amendment Instrument 2018
Purpose
This legislative instrument amends legislative instrument CASA 125/09, Drug and alcohol testing by CASA under Subpart 99.C of CASR 1998 (CASA 125/09), which sets out approvals, procedures, methods and standards required for the Civil Aviation Safety Authority (CASA) to conduct drug and alcohol testing of people who perform, or are available to perform, safety-sensitive aviation activities (SSAA).
CASA is introducing a new device for the taking and preparation of further body samples to be used for confirmatory drug testing by an approved laboratory. The new device is the Quantisal Oral Fluid Collection Device with Volume Adequacy Indicator (Quantisal device). The instrument amends CASA 125/09 to provide for the procedures to be followed by approved testers when using the Quantisal device for these purposes. The instrument is necessary because the drug testing device currently being used is no longer being imported into Australia.
Legislation
Under subsection 9 (1) of the Civil Aviation Act 1988 (the Act), CASA has the function of conducting the safety regulation of civil air operations by means that include administering Part IV of the Act. Part IV of the Act includes section 34. Under section 34, regulations may provide for drug and alcohol management plans (DAMPs) for people who perform, or are available to perform, SSAA, and for CASA to conduct drug and alcohol testing of such people.
Section 98 of the Act empowers the Governor-General to make regulations for the Act and in the interests of the safety of air navigation. Relevantly, the Governor-General has made the Civil Aviation Safety Regulations 1998 (CASR).
Part 99 of CASR gives effect to Part IV of the Act by establishing a framework for the development of DAMPs (Subpart 99.B) and by providing for a drug and alcohol testing regime, to be administered by CASA, for all persons involved in SSAA (Subpart 99.C).
Regulation 99.135 provides that an approved tester may only take a sample of a person’s oral fluid for a drug test under Subpart 99.C.
Regulation 99.140 provides that an approved tester must take and prepare a body sample for drug testing in accordance with the procedures set out in a legislative instrument made by CASA for the purposes of the regulation.
Regulation 99.170 of CASR provides that if the result of an initial drug test is a positive result, the approved tester may take a further body sample from the donor for a confirmatory drug test.
Under subsection 33 (3) of the Acts Interpretation Act 1901, where an Act confers a power to make, grant or issue any instrument of a legislative or administrative character (including rules, regulations or by-laws), the power shall be construed as including a power exercisable in the like manner and subject to the like conditions (if any) to repeal, rescind, revoke, amend, or vary any such instrument.
Subsection 98 (5D) of the Act provides that a legislative instrument made under the Act or the regulations may apply, adopt or incorporate any matter contained in any instrument or other writing as in force or existing from time to time, even if the other instrument or writing does not yet exist when the legislative instrument is made.
Background
Abbott Australasia Pty Ltd (Abbott), previously Alere, the company which provides the Alere Certus Oral Fluid Collection Device (Alere device) CASA currently uses to collect the body samples necessary for confirmatory drug testing, advised CASA in August 2018 that they were no longer importing the device due to cost. Abbott advised CASA was the only agency still using the device in Australia, and that the duty and costs involved with the importation of the devices no longer made it commercially viable for them to import the device. Abbott suggested CASA may wish to consider using the Quantisal device to collect the body samples instead of the Alere device.
The Quantisal device is widely used throughout Australia and globally, has a longer shelf life than the Alere device and is stocked ‘on shelf’. CASA has considered the instructions for use and stability studies relating to the Quantisal device, and considers it to be safe for human use. CASA confirmed with QML Pathology, the approved laboratory that performs confirmatory drug tests for CASA, that the Quantisal device is an appropriate device to use. QML Pathology advised that the device is suitable as a means for transmitting body samples.
Overview of instrument
In accordance with subsection 33 (3) of the Acts Interpretation Act 1901, this instrument amends CASA 125/09 to prescribe instructions for the use of the Quantisal device for the taking of further body samples following a positive result of an initial drug test. The samples taken will be used by an approved laboratory for a confirmatory test. The instrument substitutes the current procedure, by which body samples are taken for these purposes using the Alere device, with a procedure for taking body samples using the Quantisal device.
CASA considers that the instrument will maintain an appropriate level of aviation safety. The use of the Quantisal device by approved testers to take body samples from persons who perform, or are available to perform, SSAA will assist CASA to determine if they are affected by drugs and, if so, ensure they do not perform those aviation-related duties unless they are fit to do so.
Document incorporated by reference
The instrument refers to the tamper-evident seals marked ‘A’ and ‘B’ provided in the CASA Transmission of sample to approved laboratory form. The instrument incorporates this form as existing from time to time. This form is for use by approved testers only and is therefore not publicly available on the CASA website. However, CASA will make it available for inspection at a CASA office for free by prior arrangement.
Content of instrument
Section 1 of the instrument sets out the name of the instrument.
Section 2 provides that the instrument commences on the day after it is registered.
Section 3 provides that CASA 125/09 is amended in accordance with Schedule 1.
Schedule 1 to the instrument sets out the amendments made to CASA 125/09 by the instrument.
Item 1 of Schedule 1 to the instrument amends item 2 of Table 1 of clause 1 of Schedule 3 of CASA 125/09 by substituting item 2 of the table with a new item 2. New item 2 sets out the procedures for the use of the Quantisal device to take and prepare a further body sample where the result of an initial drug test on an earlier body sample is a positive result.
Legislation Act 2003 (the LA)
Paragraph 10 (1) (d) of the LA provides that an instrument will be a legislative instrument if it includes a provision that amends or repeals another legislative instrument. This instrument amends legislative instrument CASA 125/09. The instrument is therefore a legislative instrument, subject to tabling and disallowance under sections 38 and 42 of the LA.
Consultation
The testing procedures in CASA 125/09 were based on existing national drug and alcohol testing protocols and procedures. The amendment made by this instrument updates only one of these procedures to allow for a new testing device to be used, given the device currently being used is no longer being imported. No substantial changes have been made to these procedures other than to reflect the manufacturer’s instructions for use of the new device.
In these circumstances, CASA is satisfied that no further consultation is appropriate or reasonably practicable for this instrument for section 17 of the LA.
Office of Best Practice Regulation (OBPR)
The amendments made by the instrument will have no cost impact on business. The cost of the new testing devices will be paid for by CASA at a lower cost per device than the previously used devices. A Regulation Impact Statement (RIS) is not required in this case, as a RIS was required for the Civil Aviation Safety Amendment Regulations 2008 (No. 1) (the initial making of CASR Part 99) and RIS ORR ID: 8301A was accepted by OBPR in relation to that instrument.
Statement of Compatibility with Human Rights
The Statement of Compatibility with Human Rights at Attachment 1 has been prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011. The instrument is compatible with the relevant human rights because, the extent that it may limit human rights, those limits are reasonable, necessary and proportionate.
Making and commencement
This instrument has been made by a delegate of CASA relying on the power of delegation under subregulation 11.260 (1) of CASR.
The instrument commences on the day after it is registered and is repealed in accordance with section 48A of the LA.
Attachment 1
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the
Human Rights (Parliamentary Scrutiny) Act 2011
CASA 69/18 – CASA 125/09 (Further Body Sample Collection Procedure – Quantisal Oral Fluid Collection Device) Amendment Instrument 2018
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
The instrument replaces procedures for the taking and preparation of further body samples for confirmatory drug tests under Part 99 of the Civil Aviation Safety Regulations 1998 (CASR) with procedures using a different device, the Quantisal Oral Fluid Collection Device with Volume Adequacy Indicator (Quantisal device). The device currently being used for this purpose is no longer being imported into Australia.
Human rights implications
The legislative instrument potentially engages with the right to privacy, including the right to protection of one’s reputation, as it amends CASA 125/09 to continue arrangements for the taking of further body samples for the conduct of confirmatory drug tests on persons who perform, or are available to perform, safety-sensitive aviation activities (SSAA). The instrument also potentially engages with the right to work and rights at work, as a person may be required to undergo body sampling at work in accordance with the procedures set out in the amendments for the taking of body samples for confirmatory drug testing and may be prevented, under Part 99 of CASR, from working if confirmatory drug testing of a sample taken using these procedures shows a positive result.
However, any limits on these human rights that are a result of the amendments made by the instrument are reasonable, necessary and proportionate because they promote aviation safety. The amendments are provided for by Part 99 of CASR. Part 99 of CASR sets out a scheme for the drug and alcohol testing of persons who perform SSAA. The scheme is administered by the Civil Aviation Safety Authority and is designed to ensure persons do not perform aviation-related duties while adversely affected by drugs or alcohol. The amendments made by the instrument assist in ensuring that persons who perform SSAA are fit to perform those activities, thereby promoting the safety of aviation activities. Further, the limitations promote the right of other persons to have a safe workplace and the obligations imposed by the Privacy Act 1988 continue to apply.
Conclusion
This legislative instrument is compatible with human rights because, to the extent that it may limit human rights, those limitations are reasonable, necessary and proportionate.
Civil Aviation Safety Authority