Explanatory Statement
Civil Aviation Safety Regulations 1998
CASA 29/25 — CASA 39/20 (Drug and Alcohol Testing by CASA under Subpart 99.C of CASR) Amendment Instrument 2025
Purpose
The purpose of CASA 29/25 — CASA 39/20 (Drug and Alcohol Testing by CASA under Subpart 99.C of CASR) Amendment Instrument 2025 (the instrument) is to amend instrument CASA 39/20 — Drug and Alcohol Testing by CASA under Subpart 99.C of CASR Instrument 2020 (CASA 39/20) which sets out procedures for CASA when conducting drug and alcohol testing of people who perform safety-sensitive aviation activities (SSAAs).
The instrument would approve a new model of breathalyser to be used for initial testing of donors for alcohol. CASA intends to stop using the Lion breathalyser that is currently approved under CASA 39/20 for this purpose and instead start using the Alcolizer LE5 breathalyser (the Alcolizer). The instrument amends the procedures in CASA 39/20, where required, to refer to the Alcolizer and to set out the procedures to be followed for its operation. The instrument also makes some minor amendments to the procedures set out in CASA 39/20 for use of another approved breathalyser, for drug testing and use of approved drug‑testing devices.
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 make provision for drug and alcohol management plans (DAMPs) for people who perform SSAAs and for CASA to conduct drug and alcohol testing of such people.
Subsection 98(1) of the Act additionally provides that the Governor-General may make regulations prescribing matters required or permitted by the Act to be prescribed or necessary or convenient to be prescribed for carrying out or giving effect to the Act.
The purpose of Part 99 of the Civil Aviation Safety Regulations 1998 (CASR), Drug and alcohol management plans and testing (CASR Part 99), is to give effect to Part IV of the Act, by establishing a framework for the development of DAMPs, similar to those already in place in other transport sectors, and by introducing a drug and alcohol testing regime for all persons involved in SSAAs.
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.
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. Under subsection 13(1) of the Legislation Act 2003 (the LA), subsection 33(3) applies to legislative instruments as if each provision of the instrument were a section of an Act.
Legislative instrument under CASR Part 99
Under certain provisions of CASR Part 99, CASA may make a legislative instrument for the purposes of conducting drug and alcohol testing.
Under regulation 99.130 of CASR, for drug and alcohol testing under Subpart 99.C, CASA may, by legislative instrument, approve breathalysers for use in alcohol testing and drug‑testing devices for use in initial drug testing.
Under regulation 99.140 of CASR, 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.
Under subregulation 99.145(2) of CASR, an approved tester must ensure that the approved drug-testing device is stored, tested, maintained and operated in accordance with the legislative instrument made by CASA for the purposes of the subregulation.
Under regulation 99.150 of CASR, CASA must, by legislative instrument, specify a method for determining sample identifiers that are to be allocated to body samples that approved testers take under Subpart 99.C and send for confirmatory drug tests.
Under regulation 99.245 of CASR, an approved tester must take body samples for alcohol testing in accordance with the procedures set out in a legislative instrument made by CASA for the purposes of the regulation.
Under subregulation 99.250(3) of CASR, an approved tester must ensure that the breathalyser is stored, tested, maintained and operated in accordance with a legislative instrument made for the purposes of the subregulation.
CASA 39/20 is made for the purposes of those provisions of CASR and provides various approvals, procedures, methods and standards required for CASA to conduct drug and alcohol testing of people who perform SSAAs.
Schedule 1 of CASA 39/20 sets out the approved breathalysers for use in alcohol testing under Subpart 99.C of CASR. Table 1 currently includes the “Alcometer SD400” breathalyser (the Lion breathalyser) for use in initial alcohol testing.
Schedule 3 of CASA 39/20 sets out the procedures for an approved tester to take and prepare a body sample for drug testing under Subpart 99.C of CASR.
Schedule 4 of CASA 39/20 sets out the procedures for storing, testing, maintaining and operating an approved drug-testing device for use in initial drug testing under Subpart 99.C of CASR. Table 2 of Schedule 4 sets out procedures in relation to the drug-testing device known as “Abbott SoToxa”.
Schedule 6 of CASA 39/20 sets out the procedures for taking body samples for alcohol testing under Subpart 99.C of CASR. Item 1 sets out procedures for the Lion breathalyser. Item 2 sets out procedures for the “Drager Alcotest” breathalyser.
Schedule 7 of CASA 39/20 sets out the procedures for storing, testing, maintaining and operating an approved breathalyser for use in alcohol testing under Subpart 99.C of CASR, including procedures in relation to the Lion breathalyser.
Background
CASA 39/20 commenced on 4 August 2020 and sets out:
(a) approved breathalysers for use in alcohol testing under Subpart 99.C of CASR; and
(b) approved drug-testing devices for use in initial drug testing under Subpart 99.C of CASR; and
(c) procedures for an approved tester to take and prepare a body sample for drug testing under Subpart 99.C of CASR; and
(d) instructions for storing, testing, maintaining and operating a drug-testing device approved for use in an initial drug test under Subpart 99.C of CASR; and
(e) the specified method for determining sample identifiers to be allocated to body samples that approved testers take under Subpart 99.C of CASR and to send for confirmatory drug tests; and
(f) procedures for an approved tester to take body samples for alcohol testing under Subpart 99.C of CASR; and
(g) instructions for storing, testing, maintaining and operating a breathalyser approved for use in an initial alcohol test under Subpart 99.C of CASR; and
(h) a declaration of another Standard to which the National Association of Testing Authorities may accredit a person if the person is approved by CASA to conduct confirmatory drug tests for the purposes of Part IV of the Act.
CASA 39/20 approved the use of the Lion breathalyser for alcohol testing. CASA considers that the Alcolizer is a more efficient breathalyser, and less intrusive to the person being tested, than the Lion. Accordingly, CASA intends to stop using the Lion breathalyser and use the Alcolizer instead, which requires amendment of CASA 39/20.
CASA is also making some minor changes to the procedures for alcohol and drug testing in CASA 39/20 that do not substantially affect the approved procedures. The amendments include removing a reference to a testing device that is no longer being used and removing a word referring to the manner of packaging of a body sample collection kit.
Overview of instrument
The instrument amends CASA 39/20 to approve the Alcolizer for initial alcohol testing and procedures for its use. The effect of these amendments is to repeal CASA’s approval of the Lion breathalyser for this purpose.
In addition, the instrument makes some minor changes to the approved procedures for alcohol and drug testing, such as:
(a) changing some time limits in the approved procedures for the Drager Alcotest for confirmatory testing from 10 minutes to 15 minutes; and
(b) removing a reference to the Alere DDS-2 testing device, which is no longer being used; and
(c) removing the word “both” from a description of the approved procedure for removing parts of a body sample collection kit from their packaging. Currently these kit parts are packaged separately, but may be packaged together in future, in which case the use of the word “both” in the description of the approved procedure would be inaccurate.
CASA is satisfied that the instrument will have a beneficial impact on aviation safety as it considers the Alcolizer to be a superior breathalyser to the Lion breathalyser for alcohol testing of persons who perform SSAAs.
Provisions that enable the collection and use of personal information
Provisions that enable the collection and use of personal information and the type of information that may be collected
Items 2 and 4 of Schedule 1 to the instrument will insert into CASA 39/20 procedures for CASA to collect certain personal information from persons who perform, or are available to perform, SSAAs.
Information is collected in the form of body samples taken for the purposes of alcohol testing and drug testing. In the case of alcohol testing, breath samples are collected using breathalyser devices. In the case of drug testing, oral fluid samples are collected using swabs inside a person’s mouth.
Why the provisions that enable the collection and use of personal information are considered necessary and appropriate
The collection of body samples for the purpose of alcohol and drug testing is necessary for CASA to perform its function (conferred by section 9 of the Act) of conducting the safety regulation of civil air operations in Australian territory. The alcohol and drug testing procedures in CASA 39/20 apply in respect of persons who perform, or are available to perform, SSAAs. Drug and alcohol testing, including the provision of body samples for tests, is authorised under Part IV of the Act.
A privacy impact statement has not been prepared in this case. CASA 39/20 has been in force since 4 August 2020 and replaced instrument CASA 125/09 — Drug and alcohol testing by CASA under Subpart 99.C of CASR 1988. The alcohol and drug testing procedures CASA 39/20 sets out are similar to equivalent Australian drug and alcohol testing procedures that are established for the purpose of ensuring safety at workplaces or on the roads. The provisions for alcohol testing using the Alcolizer that are to be inserted into CASA 39/20 by the instrument are appropriate in that they set out improved, less intrusive procedures for the conduct of testing for alcohol. The remainder of the instrument makes minor amendments to procedures that are already in place.
The safeguards in place to protect personal information
CASA has safeguards in place to protect the confidentiality of the information collected under the provisions of the instrument that engage the right to protection of privacy (namely, Items 2 and 4 of Schedule 1).
As a Commonwealth government agency, CASA must comply with the Privacy Act 1988 (the Privacy Act), which establishes a privacy protection framework that protects the information collected from persons and limits its use and disclosure. CASA must also comply with the Privacy (Australian Government Agencies — Governance) APP Code 2017 (the Privacy Code). In each case, the relevant information is “personal information”, within the meaning of section 6 of the Privacy Act and is “health information” within the meaning of section 6FA of that Act (which defines health information to mean, among other things, personal information collected in connection with the donation, or intended donation, by an individual of his or her body parts, organs or body substances). The information is also “sensitive information”, which is defined in section 6 of the Privacy Act to include health information about an individual.
The obligations under the Privacy Act include obligations to comply with the Australian Privacy Principles set out in Schedule 1 to the Privacy Act. In particular, Australian Privacy Principle 3 prohibits CASA from collecting sensitive information about an individual unless the individual consents to the collection of the information and either the information is reasonably necessary for, or directly related to, one or more of CASA’s functions or activities or the collection of the information is required or authorised by or under an Australian law. The instrument satisfies those preconditions. Alcohol and drug testing is directly related to CASA’s safety regulation function and authorised under Part IV of the Act.
There are also safeguards set out in CASA’s policy. CASA’s Privacy Policy – Directive, effective from October 2023 to October 2026, deals with CASA’s collection, holding, use and disclosure of personal information, including sensitive information. It requires CASA officers to ensure compliance with: applicable privacy laws, including the Privacy Act; the CASA privacy policy available on CASA’s website, which outlines CASA’s personal information handling practices and complaint handling process; and the Privacy Code. Under CASA’s privacy policy, CASA will take reasonable steps to ensure that any personal information it collects and uses is up-to-date, complete, and secure.
Documents incorporated by reference
The instrument refers to the instructions of the manufacturer of the Alcolizer, and these are incorporated by reference as they exist from time to time. The instructions are available free of charge at: <https://www.alcolizer.com>.
Content of instrument
Section 1 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 39/20 is amended as set out in Schedule 1 to the instrument.
Schedule 1 sets out the amendments to CASA 39/20.
Item 1 of Schedule 1 substitutes a new Table 1 of Schedule 1 of CASA 39/20. Schedule 1 details the breathalysers approved for use in alcohol testing under Subpart 99.C of CASR. Table 1 sets out the details of breathalysers approved for use in initial alcohol testing. New Table 1 of Schedule 1 states the name of the manufacturer of the Alcolizer as Alcolizer Pty Ltd and its name and model as “Alcolizer LE5”. The new Table replaces the equivalent details provided in the previous Table 1 for the Lion breathalyser.
Item 2 of Schedule 1 substitutes a new Table 1 into Schedule 3 of CASA 39/20. Table 1 of Schedule 3 sets out approved procedures for taking and preparing body samples for drug testing. New Table 1 is substantially the same as the previous Table 1, with the minor changes set out below.
New Table 1 of Schedule 3 omits the word “both” from the approved procedures for using a kit, referred to as the Quantisal® Oral Fluid Collection kit, to take body samples. The kits contain 2 indicator swabs. Currently, the swabs are individually packaged within the kit and the approved procedures refer to opening both swabs’ packaging. The manufacturer may decide to package the swabs together in future. By removing the word “both” in this context, CASA ensures that the approved procedure is consistent, regardless of how the swabs are packaged.
New Table 1 of Schedule 3 also clarifies some references to a line appearing on the device after a drug test by changing the references to “indicator line” to distinguish from the control line that also appears on the device.
Item 3 of Schedule 1 removes a reference to the Alere DDS-2 drug-testing kit from the approved procedures for drug testing as that type of kit is no longer being used.
Item 4 of Schedule 1 substitutes a new Item 1 of Table 1 of Schedule 6 of CASA 39/20. Item 1 of Table 1 sets out the procedures for an approved tester to take body samples for alcohol testing using the Alcolizer. These procedures replace the procedures for use of the Lion device.
Item 5 of Schedule 1 amends Item 2 of Table 1 of Schedule 6 of CASA 39/20, which sets out procedures for the use of the Drager Alcotest breathalyser for confirmatory testing, to increase a 10-minute waiting period before confirmatory testing to a 15-minute waiting period.
Item 6 of Schedule 1 substitutes a new Item 1 into Table 1 of Schedule 7 of CASA 39/20. The effect of the amendment is to set out procedures for the storage, testing, maintenance and operation of the Alcolizer. These procedures replace the procedures for the Lion device.
Legislation Act 2003
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 instrument CASA 39/20 that was registered as a legislative instrument and is, therefore, also a legislative instrument, subject to tabling and disallowance in the Parliament under sections 38 and 42 of the LA.
Sunsetting
Part 4 of Chapter 3 of the LA (the sunsetting provisions) does not apply to the instrument or CASA 39/20, because they both relate to aviation safety and are made under CASR (Item 15 of the table in section 12 of the Legislation (Exemptions and Other Matters) Regulation 2015).
The instrument amends CASA 39/20 and is almost immediately spent and repealed in accordance with the automatic repeal provisions in section 48A of the LA.
CASA 39/20 deals with aviation safety matters and is intended to have enduring operation and it, therefore, would not be appropriate for it to be subject to sunsetting. The exemption from the sunsetting provisions affects parliamentary oversight by not requiring the instrument to be remade and subject to further tabling and disallowance in the Parliament under sections 38 and 42 of the LA.
Consultation
Consultation under section 17 of the LA has not been considered necessary for this instrument. The equipment approvals and testing procedures in CASA 39/20 are based on existing national drug and alcohol testing protocols and procedures and apply only to the procedures to be followed by CASA. They also largely replicate matters that have been in operation since 2009 in instrument CASA 125/09 — Drug and alcohol testing by CASA under Subpart 99.C of CASR 1998 and now CASA 39/20.
Sector risk, economic and cost impact
Subsection 9A(1) of the Act states that, in exercising its powers and performing its functions, CASA must regard the safety of air navigation as the most important consideration. Subsection 9A(3) of the Act states that, subject to subsection (1), in developing and promulgating aviation safety standards under paragraph 9(1)(c), CASA must:
(a) consider the economic and cost impact on individuals, businesses and the community of the standards; and
(b) take into account the differing risks associated with different industry sectors.
The cost impact of a standard refers to the direct cost (in the sense of price or expense) which a standard would cause individuals, businesses and the community to incur. The economic impact of a standard refers to the impact a standard would have on the production, distribution and use of wealth across the economy, at the level of the individual, relevant businesses in the aviation sector, and the community more broadly. The economic impact of a standard could also include the general financial impact of that standard on different industry sectors.
The instrument makes minor or machinery changes to an existing instrument and there will be no change to the economic or cost impact on individuals, businesses or the community.
Impact on categories of operations
The amendments made by the instrument relate to CASA’s own regulatory functions and procedures, and are expected to have a beneficial effect on the safety of air transport operations and operations by private operators because CASA will be using the most efficacious devices and up-to-date procedures to conduct its alcohol and drug-testing operations on persons performing SSAAs.
Impact on regional and remote communities
The instrument is unlikely to have any specific effect on regional and remote communities, as it applies to CASA’s procedures regarding SSAAs, which apply in respect of all communities.
Office of Impact Analysis (OIA)
A preliminary assessment of business compliance costs indicates that the legislative instrument, as such, will have no cost impact on business. A Regulatory Impact Statement was required for the Civil Aviation Safety Amendment Regulations 2008 (No. 1) (the initial making of Part 99 of CASR) and, accordingly, CASA prepared Regulation Impact Statement ORR ID: 8301A which was accepted by the Office of Best Practice Regulation. As this amendment is of a minor or machinery nature, no further assessment has been conducted in respect of the 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.
Making and commencement
The 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 automatically 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 29/25 — CASA 39/20 (Drug and Alcohol Testing by CASA under Subpart 99.C of CASR) Amendment Instrument 2025
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 purpose of CASA 29/25 — CASA 39/20 (Drug and Alcohol Testing by CASA under Subpart 99.C of CASR) Amendment Instrument 2025 (the instrument) is to amend instrument CASA 39/20 — Drug and Alcohol Testing by CASA under Subpart 99.C of CASR Instrument 2020 (CASA 39/20), which sets out procedures for CASA when conducting drug and alcohol testing of people who perform safety-sensitive aviation activities (SSAAs).
CASA 39/20 approved the use of the Lion breathalyser for alcohol testing. CASA considers that the Alcolizer LE5 breathalyser (the Alcolizer) is a more efficient breathalyser, and less intrusive to the person being tested, than the Lion. Accordingly, CASA intends to stop using the Lion breathalyser and instead use the Alcolizer. Amendments to CASA 39/20 are required to implement this change.
CASA is also making some minor changes to the current procedures for drug testing in CASA 39/20. The amendments include removing a reference to a testing device that is no longer being used and removing a word referring to the manner of packaging of a body sample collection kit.
The instrument amends the procedures in CASA 39/20 where required, to replace the references to, and procedures for, the Lion device with references to, and procedures for, the Alcolizer. The instrument also makes some minor amendments to the procedures in CASA 39/20 for use of another approved breathalyser, for drug testing and use of approved drug-testing devices.
Human rights implications
CASA 39/20 potentially engages with the right to privacy, including the right to protection of one’s reputation, as it relates to the taking of body samples for the conduct of alcohol and drug tests on persons who perform, or are available to perform, SSAAs. 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 for the taking of body samples for alcohol and drug testing and may be prevented, under Part 99 of CASR, from working if confirmatory alcohol or drug testing of a sample taken using these procedures shows a positive result.
However, any limits on these human rights are reasonable, necessary and proportionate because they promote aviation safety. Part 99 of CASR sets out a scheme for the drug and alcohol testing of persons who perform SSAAs. The scheme is administered by CASA and is designed to ensure persons do not perform aviation-related duties while adversely affected by drugs or alcohol. The instrument assists in ensuring that persons who perform SSAAs are fit to perform those activities, thereby promoting the safety of aviation activities and their own safety. Further, the limitations promote the right to life of other persons by ensuring persons affected by drugs or alcohol do not conduct SSAAs, and the right of other persons to have a safe workplace. The obligations imposed by the Privacy Act 1988 continue to apply.
Conclusion
This legislative instrument is compatible with human rights as it does not raise any human rights issues.
Civil Aviation Safety Authority