Explanatory Statement
Civil Aviation Safety Regulations 1998
Exemption — CASR Part 99 Standard for drug testing
Purpose
This instrument exempts certain persons who conduct drug tests under drug and alcohol management plans (DAMPs) from having to meet a particular aspect of the Standards for oral fluid and urine drug testing.
Legislation for exemption from CASR 1998
Under subregulation 11.160 (1) of the Civil Aviation Safety Regulations 1998 (CASR 1998), CASA may grant an exemption from compliance with a provision of CASR 1998. Under regulation 11.160, CASA may grant an exemption of its own initiative. Under subregulation 11.170 (3), in deciding whether to grant an exemption, CASA must regard as paramount the preservation of an acceptable level of safety.
Under subregulation 11.205 (1), CASA may impose conditions on an exemption if this is necessary in the interests of the safety of air navigation. Under regulation 11.210, it is an offence to fail to comply with a condition of an exemption.
Under regulation 11.225, an exemption must be published on the World Wide Web. Under subregulation 11.230 (1), an exemption ceases on the day specified within it (but no longer than 2 years after its commencement), or if no day is specified, 2 years after commencement.
Other 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 DAMPs for people who perform safety-sensitive aviation activities (SSAA), 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.
Drug and alcohol regulations
The Civil Aviation Safety Amendment Regulations 2008 (No. 1), commenced on 23 September 2008 and amended CASR 1998 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 SSAA.
CASR Part 99
Under the definitions in subregulation 99.010 (1) of CASR 1998, 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 must be in accordance with the relevant 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.
Under subparagraph 99.050 (1) (a) (iii), urine testing must be in accordance with the relevant 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.
Exemption and conditions
Currently, for on-site initial drug testing in the transportation and other relevant industries, it has been found to be extremely difficult, if not impossible, to carry out the batch pre-testing quality control procedures for oral fluid testing devices. The batch pre‑testing verification of performance procedures for urine testing devices are also challenging for on-site testers.
Ideally, batch pre-testing quality control procedures and verification of performance procedures should be performed by suppliers of the relevant devices as part of a supply contract because suppliers are in the best position to conduct such tests and offer the requisite guarantee of quality and performance. However, this is not currently the case in Australia.
The exemption is, therefore, necessary, temporarily to relieve DAMP organisations of the obligation to carry out batch pre-testing quality control procedures and verification of performance procedures for oral fluid and urine until CASA and industry develop suitable arrangements for such testing. It is expected that this will be completed within about 6 months and the exemption will then be revoked and replaced by a similar exemption that imposes, as a condition, a requirement of compliance with the new batch pre-testing quality control and verification of performance procedures.
Case for the exemption
The exemption applies only for the conduct of on-site initial drug testing. It applies only for such testing by a DAMP organisation. It does not apply to testing by CASA and, therefore, no question arises of the unfair imposition of a criminal penalty on the basis of a false positive test by a device that was not guaranteed by batch pre-testing quality control and verification of performance procedures.
The exemption applies only to suspend for 6 months the requirement for compliance with batch pre-testing quality control and verification of performance procedures. At the end of that time, appropriate batch pre-testing quality control and verification of performance procedures will have been developed in consultation with the aviation industry.
The exemption applies only in respect of oral fluid and urine testing devices. Compliance with the relevant oral fluid standard is considered to be impracticable for on-site DAMP organisation testers. Compliance with the relevant urine standard is also considered to be difficult. It would unreasonably distort the preferred choice of particular testing devices to exempt only oral fluid testing devices but not also urine testing devices.
Details of the exemption are set out in Attachment 1.
Legislative Instruments Act
Under subparagraph 6 (d) (i) of the Legislative Instruments Act 2003 (the LIA), an instrument is a legislative instrument for section 5 of the LIA if it is declared to be a disallowable instrument under legislation in force before the commencement of the LIA. Regulation 11.215 of CASR 1998 declares an exemption of this kind to be a disallowable instrument. The exemption is, therefore, a legislative instrument and it is subject to tabling and disallowance in the Parliament under sections 38 and 42 of the LIA.
Consultation
Consultation under section 17 of the LIA has not been undertaken in this case because of immediate time constraints. The exemption is beneficial in effect in that it relieves relevant DAMP organisations from an obligation. CASA will be revoking the exemption within 6 months during which time it will be consulting with the industry on developing suitable batch pre-testing quality control and verification of performance procedures. Compliance with those procedures will be made a condition in a new exemption issued at that time.
Office of Best Practice Regulation
The exemption relieves of an obligation. The Office of Best Practice Regulation does not require preparation of a Regulation Impact Statement in this case because a preliminary assessment of business compliance costs in the context of the nature of the instrument indicates that it will have only a nil to low impact on business.
Commencement and making
The instrument commences on 23 March 2009 and ceases to have effect at the end of 22 September 2009.
The exemption has been made by the Director of Aviation Safety, on behalf of CASA, in accordance with subsection 84A (2) of the Act.
[Instrument number CASA EX26/09]
ATTACHMENT 1
Details of exemption
1 Commencement
Under this section, the instrument commences on 23 March 2009 and stops having effect at the end of 22 September 2009.
2 Definitions
Under this section, terms are defined as follows:
oral fluid Standard means the relevant Standard mentioned in paragraph (c) of the definition of relevant Standard in subregulation 99.010 (1) of CASR 1998.
urine Standard means the relevant Standard mentioned in paragraph (d) of the definition of relevant Standard in subregulation 99.010 (1) of CASR 1998.
3 Application to an organisation’s DAMP
Under this section, the instrument applies to drug testing under the DAMP of an organisation to which Subpart 99.B of CASR 1998 applies.
4 Exemption — quality control procedures for oral fluid and urine testing
Under this section, the organisation’s DAMP is exempt from compliance with subparagraphs 99.050 (1) (a) (ii) and (iii) of CASR 1998 (the relevant Standards) to the extent mentioned in section 5.
5 Extent of exemption
Under this section, the exemption in section 4 extends to the requirement for compliance with the quality control procedures specified in paragraph (d) and the subsequent 5 paragraphs of subsection 3.2 of the oral fluid Standard (as defined). The exemption in section 4 also extends to the procedures mentioned in paragraph 1.3.36 and Appendix B of the urine Standard for verification of performance of on-site devices.