Explanatory Statement
Civil Aviation Safety Regulations 1998
Exemption — DAMP organisations collecting and screening of oral fluid and urine body samples outside capital cities
Legislation – exemption
Under subsection 98 (1) of the Civil Aviation Act 1988 (the Act), the Governor-General may make regulations for the Act and the safety of air navigation. Under subsection 98 (5A) of the Act, the regulations may empower CASA to issue instruments in relation to matters affecting the safe navigation and operation, maintenance, and airworthiness of aircraft, and design standards for aircraft.
Subregulation 11.160 (1) of the Civil Aviation Safety Regulations 1998 (CASR) provides that, for subsection 98 (5A) of the Act, CASA may grant an exemption from a provision of the regulations in relation to a matter mentioned in that subsection. 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.
Subregulation 11.205 (1) of CASR provides that an exemption may be made subject to any condition necessary in the interests of the safety of air navigation.
Under regulation 11.225 of CASR, 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.
Legislation — drug and alcohol
Under subsection 9 (1) of 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 safety-sensitive aviation activities (SSAAs), and for CASA to conduct drug and alcohol testing of such people.
The Civil Aviation Safety Amendment Regulations 2008 (No. 1) commenced on 23 September 2008 and amended CASR by inserting a new Part 99, Drug and alcohol management plans and testing (CASR Part 99).
The purpose of the amendment regulations was 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 random drug and alcohol testing regime for all persons involved in SSAAs.
Under the definitions in subregulation 99.010 (1) of CASR, a DAMP means a drug and alcohol management plan that complies, or purports to comply, with the requirements of regulation 99.045.
Under subparagraph 99.045 (b) (ii), a DAMP must include a drug and alcohol testing program that, among other things, meets the requirements specified in regulation 99.050.
Under subparagraph 99.050 (1) (a) (ii), oral fluid testing for drugs must be in accordance with the Standard mentioned in paragraph (c) of the definition of relevant Standard, namely, AS 4760, Procedures for specimen collection and the detection and quantitation of drugs in oral fluid (oral fluid standard).
Under subparagraph 99.050 (1) (a) (iii), urine testing for drugs must be in accordance with the Standard mentioned in paragraph (d) of the definition of relevant Standard, namely, AS/NZS 4308, Procedures for specimen collection and the detection and quantitation of drugs of abuse in urine (urine standard).
Incorporation of non-legislative instruments
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.
In accordance with subsection 98 (5D) of the Act, the oral fluid standard and urine standard (the applicable standards) are incorporated into the instrument as they exist from time to time.
The preface to the oral fluid standard states that the objective of the standard is to:
provide requirements and guidance on the mechanisms of incorporation of drugs in oral fluid, factors that might affect drug concentration, applicability of oral fluid for drug testing and general issues related to drug detection onsite and in the laboratory. Also to ensure that the preliminary (if not already conducted onsite) and confirmatory laboratory procedures meet the needs for the detection and quantitation of drugs in oral fluid.
The preface to the urine standard states that the objective of the standard is to:
ensure that the detection of drugs in urine meets the expectations for testing of specimens for medico-legal, workplace or court-directed purposes. This Standard addresses appropriate procedures for the collection of urine, on-site screening, handling and dispatch of specimens to the laboratory for screening and confirmatory tests. Testing for clinical use or in sport is not covered.
Despite its searches, CASA has not been able to identify any freely available online or library source of the applicable standards. The standards can be purchased online from several entities, including SAI Global and Standards New Zealand. CASA is unable to make the applicable standards available due to copyright restrictions.
The applicable standards relate to matters that are not specific to aviation, although they relate to matters that impact aviation safety. CASA does not have the expertise or resources to set standards for training, collection of body samples, testing of samples or acceptable testing devices in relation to drug testing to be implemented by entities that provide services to DAMP organisations but are not necessarily part of the aviation community regulated by CASA.
In these circumstances, to ensure that the relevant drug testing activities are conducted to appropriate standards in the interests of aviation safety, CASA has determined that the most appropriate course is to incorporate the applicable standards that are nationally recognised even though they are not freely available.
It is also CASA’s expectation that DAMP organisations would not need to purchase the applicable standards as the course of instruction would be completed by a registered training organisation that has incorporated the information in the applicable standards into their courseware.
Training requirements under the applicable standards
Clause 1.3.13 of oral fluid standard (AS 4760) defines a collector as a person who has successfully completed a course of instruction in compliance with the standard for specimen collection, storage, handling and despatch, and received a statement of attainment in accordance with the Australian Quality Training Framework (AQTF).
Clause 3.1 of oral fluid standard provides that on-site testing for oral fluids shall be performed by a technician from an accredited collecting agency. Clause 1.3.38 of the oral fluid standard requires that a technician must have successfully completed a course of instruction in compliance with the standard for on-site testing, and received a statement of attainment in accordance with the AQTF.
Clause 1.3.24 of the urine standard (AS/NZS 4308) defines on-site screening as a screening test carried out at the point of collection. Clause 1.3.32 defines screening tests as methods used to exclude the presence of a drug, or class of drugs, and to identify whether specimen integrity is compromised. Collection for this purpose is done by a collector.
Clause 1.3.14 of the urine standard defines a collector as a person who has successfully completed a course of instruction for specimen collection and on-site screening (if applicable), handling, storage and despatch of specimens and who has received a statement of attainment in accordance with the AQTF or New Zealand Qualifications Authority (NZQA).
Collecting agency requirements under the applicable standards
The applicable standards set out the roles and tasks of collecting agencies. Consistent with the applicable standards, the instrument defines collecting agency to cover an organisation assuming professional, organisational, educational and administrative responsibility for collection, on-site screening (if applicable), storage and despatch of urine specimens, and hence parallel responsibility for collectors.
The applicable standards describe on-site specimen collection and screening procedures, including the role and tasks of a collecting agency.
The applicable standards also specify requirements and verification standards for devices that can be used under the standards.
DAMP organisations in remote and regional Australia
There are DAMP organisations located in remote and regional Australia which must, under the terms of their DAMP, conduct drug testing in accordance with the applicable standards using technicians and collectors as defined above in terms of having successfully completed a course of instruction, and being collectors of a collecting agency.
However, in remote and regional Australia, such trained persons and collecting agencies are not available for urine or oral specimen collection and on-site urine testing. In the short to medium term, they are not likely to become available unless small DAMP organisations go to the large expense of sending appropriate persons for training in initial drug testing in 1 of the major Australian cities where training courses may periodically be run, and the DAMP organisation in turn establishes itself as a collecting agency with its associated overheads and requirements. Alternatively, commercial collecting agencies with trained collectors may expand their reach into remote and regional Australia, but this has not yet occurred.
How to ensure effective DAMP testing in remote and regional Australia
CASA considers it is not realistic at this stage to expect that the testers used by DAMP organisations in remote and regional Australia will complete such training or that the DAMP organisations will establish themselves as collecting agencies. CASA has, therefore, issued a general exemption from specific training and collection agency requirements. The exemption is, however, tightly circumscribed by conditions designed, as far as practicable, to require alternative and acceptable tester training, and the use of proven, highly reliable, urine specimen testing equipment. It is intended in this way to protect the integrity of DAMP organisations’ drug testing.
Instrument
The instrument continues the arrangement in instrument CASA EX84/14 that expires on 30 June 2017.
The effect of the exemption in section 5 of the instrument is that a DAMP organisation is not required to have a DAMP that complies with the applicable standards insofar as the standards are relevant to the collection of body samples in remote and regional Australia for the purpose of drug screening and for the conduct of such screening.
Section 6 of the instrument limits the extent of the exemption to permit specified persons to perform the role and tasks of a collecting agency in relation to the collection and screening of oral fluid and urine samples (the screening of oral fluid samples is excluded by a subsequent condition in the instrument).
The role and tasks may be undertaken by a “trained collector”, “doctor” or “nurse” each of which must have successfully completed a “course of instruction” in the relevant applicable standard. A course of instruction means, in effect, an accredited course within the AQTF or the NZQA. Utilisation of these persons in effect exempts the DAMP organisation from meeting the requirements of AS/NZS 4308 for the role and involvement of a collecting agency when utilised in remote and regional Australia.
The role or tasks may also be undertaken by a capable person, defined to be a person who provides specified information to CASA that the person has completed training and is competent to collect oral fluid or urine body samples and to conduct screening of urine body samples. Training is defined for the definition of capable person.
Section 6 also limits the extent of the exemption to ensure that the permitted collection and screening activities are otherwise carried out in accordance with the requirements of the applicable standards, including the verification and other requirements for devices specified in the applicable standards.
Remote and regional Australia
The exemption applies to areas outside Australian capital cities. The capital cities are defined by reference to the Greater Capital City Statistical Area delineated in the Australian Statistical Geography Standard (ASGS) maintained by the Australian Bureau of Statistics (ABS). In accordance with subsection 98 (5D) of the Act, the ASGS and the Greater Capital City Statistical Area are incorporated into the instrument as they exist from time to time. The documents are freely available online and can be downloaded through the ABS website.
The Greater Capital City Statistical Area is presently able to be downloaded at http://www.abs.gov.au/ausstats/abs@.nsf/mf/1270.0.55.001.
The reason it does not apply within capital cities is that, in CASA’s view, Australian capital cities currently have an adequate number of Standards-accredited collecting agencies to meet collecting and testing demand. There are also, within the capital cities, appropriate training opportunities for doctors and nurses to meet the Standard and become accredited for this potentially expanding role. It is CASA’s intention to allow departure from the Standards only where it is clearly necessary and with the application of acceptable alternative procedures.
The circumstances outside capital cities are different to those within capital cities — there is not an adequate number of reasonably accessible Standards-accredited collecting agencies to meet demand, nor is there reasonably accessible training for Standards accreditation of doctors and nurses (and others).
The exemption is therefore intended to assist DAMP organisations in remote and regional Australia by facilitating the use of doctors, nurses and other persons who have undertaken required training in such areas. To address the contingency, medical professionals in these areas can carry out drug testing for DAMPs provided they meet the requirements of the exemption.
The exemption does not apply to enable a DAMP organisation to collect a sample in a capital city and to send the sample to a remote or regional area for screening in accordance with the requirements of the instrument.
Conditions
For regulation 11.205 of CASR, section 7 of the instrument imposes conditions on the exemption.
It is a condition that a capable person may perform the role or tasks of a collecting agency, as permitted by the exemption and extent of the exemption in sections 5 and 6, only if a doctor, nurse or a trained collector is not reasonably available because of the remoteness of the location of the DAMP organisation at which the role or tasks are to be performed.
It is also a condition that on-site screening of oral fluid body samples must not be carried out by trained collectors, doctors, nurses or capable persons. This is because appropriate testing devices that are acceptable to CASA for this kind of usage in these kinds of circumstances are not yet available.
Legislation Act 2003 (the LA)
For subsection 98 (5A) of the Act, CASA may, by instrument, grant an exemption from compliance with a provision of the regulations. An instrument issued under paragraph 98 (5A) (a) of the Act is a legislative instrument if the instrument is expressed to apply to a class of persons.
The exemption applies to classes of persons being DAMP organisations, trained collectors, doctors, nurses and capable persons. The exemption is, therefore, a legislative instrument subject to tabling and disallowance in the Parliament under sections 38 and 42 of the LA.
Consultation
Consultation under section 17 of the LA was undertaken for the initial issue of this exemption, instrument CASA EX27/09, in 2009 with the Australian Aerial Agricultural Association and with representatives of larger airlines. Further consultation with the National Association of Testing Authorities Australia (NATA) led to another issue of the exemption, instrument CASA EX82/10. No specific consultation was undertaken with respect to the other previous iterations of this exemption, instruments CASA EX117/12, CASA EX112/13 and CASA EX84/14, except in relation to the omission of specific prescribed devices from CASA EX84/14. The requirements for devices are mentioned in the applicable standards, which are now relevantly incorporated in the extent of the exemption in section 6.
In these circumstances CASA is satisfied that no consultation is appropriate or necessary for this instrument for section 17 of the LA.
Statement of Compatibility with Human Rights
A Statement of Compatibility with Human Rights is at Attachment 1.
Office of Best Practice Regulation (OBPR)
The exemption is beneficial in effect by relieving persons of an obligation to comply with certain aspects of the DAMP testing requirements. A Regulation Impact Statement (RIS) is not required because the exemption is covered by a standing agreement between CASA and OBPR under which a RIS is not required for exemptions (OBPR id: 14507).
Making and commencement
The exemption has been made by a delegate of CASA, relying on the power of delegation in subregulation 11.260 (1) of CASR.
The instrument commences on 1 July 2017, the day after the present exemption instrument is repealed. The instrument is repealed at the end of 30 June 2020.
[Instrument number CASA EX74/17]
Attachment 1
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the
Human Rights (Parliamentary Scrutiny) Act 2011
Exemption — DAMP organisations collecting and screening of oral fluid
and urine body samples outside capital cities
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 legislative instrument exempts doctors and nurses, who conduct drug tests under drug and alcohol management plans (DAMPs) for DAMP organisations, from having to meet certain additional training and other requirements of the Australian Standard for drug testing, provided they meet particular conditions, including alternative training standards. The exemption only applies outside capital cities as defined.
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