Explanatory Statement
Civil Aviation Safety Regulations 1998
Amendment of instrument CASA 125/09 — Drug and alcohol testing by CASA under Subpart 99.C of CASR 1998
Purpose
This legislative instrument (the Amendment) amends the previous legislative instrument made for and under various provisions of Part 99 of the Civil Aviation Safety Regulations 1998 (CASR 1998), for various approvals, procedures, methods and standards required for CASA to conduct random drug and alcohol testing of people who perform safety-sensitive aviation activities (SSAA). The Amendment replaces the procedures for the previous initial drug test with a new 2-step initial drug test. This involves use of an additional device and procedures for storing and testing. The Amendment also clarifies the procedures for the conduct of initial alcohol tests to remove reference to what a person to be tested may have eaten or drunk, and to substitute reference to whether the person has consumed anything containing alcohol.
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 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.
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 CASR Part 99 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.
Legislative instrument under CASR Part 99
Under certain provisions of CASR Part 99, CASA may make a legislative instrument for the purposes of conducting random drug and alcohol testing.
Thus, under regulation 99.130 of CASR 1998, 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 1998, 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 1998, 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 1998, 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 1998, 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 1998, 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.
Under paragraph 99.445 (3) (b) of CASR 1998, CASA may approve a person to conduct confirmatory drug tests for the purposes of Part IV of the Act if the National
Association of Testing Authorities accredits the person to AS 4760, Procedures for specimen collection and the detection and quantitation of drugs in oral fluid, or to
another Standard that is declared by CASA in a legislative instrument made for the purposes of the paragraph.
Background
On 25 March 2009 CASA made a legislative instrument for the purposes of the provisions mentioned above to enable drug and alcohol testing to begin. The legislative instrument took effect on 1 April 2009.
The legislative instrument provided for initial drug testing to be conducted using the approved Cozart DDS testing device. CASA has decided to refine the initial drug test procedures by introducing a 2-step initial drug testing process comprising 2 screening tests. These are Step 1 using the DrugWipe 5+ approved testing device, and Step 2 using the approved Cozart DDS testing device.
These 2 testing devices test for the presence of testable drug groups with differing degrees of sensitivity. These groups are the pharmacological groupings into which particular testable drugs, as specified by the Minister under section 33 of the Act, fall, namely, the amphetamine group (known also as the amphetamine and methamphetamine group), the cannabis group, the cocaine group, and the opiates group.
Thus, for testing purposes, if there is a Step 1 DrugWipe 5+ screening negative (Scenario 1), drug testing is complete and the result of the initial drug test is a negative result.
However, if there is a Step 1 DrugWipe 5+ screening positive (Scenario 2), there must follow a Step 2 Cozart DDS screening test. There can be no Step 2 Cozart DDS screening test unless and until there has been a Step 1 DrugWipe 5+ screening positive.
If there is a Step 2 Cozart DDS screening negative (Scenario 3), drug testing is now complete and the result of the initial drug test is a negative result.
Under Scenario 3, the result of the initial drug test will be considered to be a negative result even though there was a Step 1 DrugWipe 5+ screening positive. This is because in the current sate of testing technology, CASA does not consider that a Step 1 DrugWipe 5+ screening positive alone is sufficiently certain and reliable to cause the person tested to cease performing or being available to perform safety sensitive aviation activies.
However, if there is a Step 1 DrugWipe 5+ screening positive for any testable drug group (Scenario 2), followed by a Step 2 Cozart DDS screening positive for any testable drug group (Scenario 4), this will be regarded as a Step 2 screening positive and the result of the initial drug test will be a positive result.
Scenario 4 is an initial drug test positive result:
(a) for each testable drug group which returned a positive result under Step 1 DrugWipe 5+; and
(b) each testable drug group which returned a positive result under Step 2 Cozart DDS. (These groups may or may not be the same as those which returned a positive result under Step 1 DrugWipe 5+.)
In this event, the tester proceeds to the steps required for confirmatory testing.
The 2-step initial drug testing process using the DrugWipe 5+ approved testing device and the approved Cozart DDS testing device, and also the consequences of the Scenarios mentioned above, all mirror aspects of the established drug testing practices of the State police services in Victoria and South Australia with whom CASA conferred for information.
As noted above, procedures for storing and testing etc the DrugWipe 5+ approved device are also included in the Amendment. The Amendment also clarifies the procedures for the conduct of initial alcohol tests to ensure initial focus is not on consumption of food generally, but on consumption of anything containing alcohol which may distort results.
Details of the legislative instrument
Details of the Amendment are set out in Attachment 1.
Legislative Instruments Act 2003
The various provisions of CASR Part 99 mentioned above under which the Amendment was made expressly indicate that the matters are to be provided for by legislative instrument.
Subsection 15AE (1) of the Acts Interpretation act 1901 provides that if a provision of a law requires or permits an instrument that is described as a legislative instrument to be made, then the instrument so made is a legislative instrument for the purposes of the Legislative Instruments Act 2003 (LIA).
The instrument is, therefore, a legislative instrument, subject to tabling and disallowance in the Parliament under sections 38 and 42 of the LIA.
Consultation
As with the legislative instrument itself, consultation under section 17 of the LIA has not been considered necessary for the Amendment. In the legislative instrument, equipment approvals and testing procedures were based on existing national drug and alcohol testing approvals and procedures, and apply only to the procedures to be followed by CASA. The Amendment is a refinement of these, taking into account recent information about drug testing in particular by the State police services in both Victoria and South Australia.
Office of Best Practice Regulation (OBPR)
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 1998) and, accordingly, CASA prepared RIS ORR ID: 8301A at that time which was accepted by OBPR.
Commencement and making
The instrument commences on the day after it is registered. It 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 263/09]
Attachment 1
Details of the Amendment for drug and alcohol testing
Section 1
Commencement
This section provides that the instrument commences on the day after it is registered.
Section 2
Amendment of instrument CASA 125/09
Under this section, Schedule 1 amends legislative instrument CASA 125/09 providing for certain matters under Subpart 99.C of CASR 1998.
Schedule 1 Amendments
1 Schedule 2, clause 1, Table 1, item 1
Schedule 2 deals with approved drug testing devices for initial testing. This amendment adds the Securetec Detektions-Systeme AG DrugWipe 5+ to the list of approved initial drug testing devices.
2 Schedule 3, clause 1, Table 1, item 1
Schedule 3 deals with the procedures for taking and preparing body samples for drug testing. This amendment creates the new procedures for the 2-step process for initial drug testing.
All of the procedures for the DrugWipe 5+ are new because this is a newly approved testing device.
The procedures for the Cozart DDS device are largely the same as before the Amendment, except that use of Cozart is now dependent on there first being a DrugWipe 5+ screening positive result in Step 1.
Thereafter, the Cozart DDS result determines whether confirmatory drug testing is required and whether the donor is required to cease performing or being available to perform safety sensitive aviation activities pending the outcome of that confirmatory testing.
This will occur if there is a Cozart DDS positive result for any testable drug group, regardless of whether that particular group was indicated by the DrugWipe 5+ screening test. But in this scenario, the testable drug groups which gave a positive result to the DrugWipe 5+ will also be the subject of confirmatory testing if different from the Cozart DDS groups giving positive results.
Thus, at the end of the 2-step test, the result of the initial drug test will be a positive test result for:
(a) each testable drug group which returned a positive result under Step 1; and
(b) each testable drug group which returned a positive result under Step 2.
If, however, the only positive test result is the Step 1 DrugWipe 5+ screening test, without confirmation from Cozart DDS, and without Cozart DDS testing positive for some other testable drug group, the result of the initial drug test will be a negative test result and no laboratory confirmation of the test will be sought. However, in this case, testing will be conducted on the relevant de-identified sample for quality control purposes and feedback.
This procedure for assessing the outcome of the initial drug test using the described 2-step process is consistent with the long-established practices of the State police services in both Victoria and South Australia.
Testable drug group is defined for this purpose as the pharmacological grouping into which particular testable drugs fall, namely, the amphetamine- group (sometimes known as the amphetamines and methamphetamines group), the cannabis group, the cocaine group, and the opiates group.
3 Schedule 4, clause 1
This is a mechanical amendment to allow for the additional Table in amendment 4.
4 Schedule 4, clause 1, Table 1
Schedule 4 deals with the procedures for storing, testing, maintaining and operating approved drug testing devices. This amendment omits Table 1 containing the procedures for storing, testing, maintaining and operating Cozart DDS and places them, unchanged, in a new Table 2.
The amendment places in the vacated Table 1 the procedures for storing, testing, maintaining and operating the DrugWipe 5+. Thus, storing must be in a manner not inconsistent with the manufacturer’s instructions for storing the device, provided that compliance with any action recommended in those instructions is to be regarded as mandatory.
Testing must be in a manner not inconsistent with the manufacturer’s instructions for testing the device, provided that compliance with any action recommended in those instructions is to be regarded as mandatory.
Maintenance is not required as the device is a one-use only device and is disposed of after use.
Operating must be in a manner not inconsistent with the manufacturer’s instructions for operating the device.
5 Schedule 6, clause 1, Table 1, item 1 and related amendments
Schedule 6 deals with the procedures for taking body samples for alcohol testing. This amendment, in association with amendments 6, 7 and 8, provides for a correct focus on consumption of anything containing alcohol rather than on consumption as such.
If a person has consumed some comestible containing alcohol within the 10 minutes before an alcohol test would take place, the presence of the alcohol in the person’s mouth would distort testing results. To avoid this distortion, the approved tester, before testing, must wait until at least 10 minutes have elapsed since the person stated, in answer to the tester’s question, that they had consumed something containing alcohol. The amendment states:
The approved tester must first ask the donor if he or she has consumed anything containing alcohol in the preceding 10 minutes.
If the donor advises that he or she has consumed something containing alcohol in the preceding 10 minutes, the approved tester must request the donor not consume anything further (except water) until the testing, including confirmatory testing if necessary, is completed. The approved tester must inform the donor that if he or she consumes anything further (except water) until the testing, including confirmatory testing if necessary, is completed. it may be considered that he or she has refused, or failed to give a body sample.
If the donor has advised the approved tester that he or she has consumed something containing alcohol in the preceding 10 minutes, the approved tester must wait until at least 10 minutes have elapsed since the tester first asked the donor if he or she had consumed anything containing alcohol.
Provided that the donor has not consumed anything containing alcohol in the preceding 10 minutes, the approved tester can ask the donor to remove the protective cellophane packaging and provide a sample of the donor’s breath.
For confirmatory alcohol testing (which must occur not sooner than 15 minutes after the initial alcohol test sample was taken), if the approved tester has reason to believe that the donor may have consumed something containing alcohol since giving the initial sample, the approved tester must again ask the donor if he or she has consumed anything containing alcohol in the preceding 10 minutes.
If the donor advises that he or she has consumed something containing alcohol in the preceding 10 minutes, the approved tester must either:
(a) inform the donor that he or she is considered to have refused or failed to have given a body sample; or
(b) wait until at least 10 minutes have elapsed since the tester last asked the donor if he or she had consumed anything containing alcohol.
This option is provided to the approved tester in order to address the possibility that a donor may make an innocent error by consuming something containing mouth alcohol. But a donor will not be able to do this repeatedly – which would be the risk if the option were not provided to the tester.
A Note indicates that the consequences of a refusal or failure to provide a body sample are set out in regulation 99.335 of CASR 1998. These consequences include a requirement, reinforced by a penalty, that the person must not again perform or be available to perform an applicable safety sensitive aviation activity until satisfactory alcohol testing has been completed under the regulations.
Provided that the donor has not consumed anything containing alcohol in the preceding 10 minutes, the approved tester can ask the donor to place the end of the mouth piece into the donor’s mouth and to seal his or her lips around it for confirmatory testing.