Instrument number CASA 263/09
I, John Francis mcCormick, Director of Aviation Safety, on behalf of CASA, make this instrument under regulations 99.130 and 99.140, subregulation 99.145 (2), regulations 99.150 and 99.245, subregulation 99.250 (3) and paragraph 99.445 (3) (b) of the Civil Aviation Safety Regulations 1998 (CASR 1998).
[Signed John F. McCormick]
John F. McCormick
Director of Aviation Safety and
   Chief Executive Officer
17 June 2009
Amendment of instrument CASA 125/09 — Drug and alcohol testing by CASA under Subpart 99.C of CASR 1998
1          Commencement
            This instrument commences on the day after it is registered.
2          Amendment of instrument CASA 125/09
            Instrument CASA 125/09 is amended as set out in Schedule 1.
Schedule 1          Amendments
1          Schedule 2, clause 1, Table 1, item 1
substitute
Item
Name of manufacturer
Name and model of drug testing device

1
Securetec Detektions-Systeme AG
DrugWipeÒ 5+

2
Cozart plc
Cozart DDS

2          Schedule 3, clause 1, Table 1, item 1
substitute
Item
Drug test
Procedures

1(a)
For the conduct of Step 1 of an initial drug test using the DrugWipeÒ 5+ approved drug testing device in association with the Cozart DDS approved drug testing device
Step 1 — Taking body samples with the DrugWipeÒ 5+ approved testing device (the device):
Having checked that the device has not passed its expiry date, the approved tester is to separate the saliva collector (sometimes also called a “swab”) of the device from the detection element.
The approved tester is then to ask the donor to moisten the inside of his or her cheeks by rolling the tongue around the inside of the mouth.
The approved tester is then to ask the donor to hold the saliva collector in one hand and apply moderate pressure in using the saliva collector to wipe his or her tongue in a downward and circular movement, and to wipe the inside of his or her cheeks making circular movements.
Preparing body samples:
Once a saliva sample has been obtained, the approved tester is to:
•   Reattach the saliva collector to the detection element. A double click will be heard on successful reattachment.
•   Bring the device into a vertical position and by pressing with a thumb on the crosshairs marked on the ampoule unit open the ampoule. A snap will be heard on the successful opening of the ampoule. After this snap is heard, hold the device vertically for a further 10 seconds.
•   Place the device horizontally on a surface for a period of not less than 7 minutes but not more than 10 minutes. After a time within this period, the display window on the device will show the red control line (CL).
•   After a further time, but still within the 10 minute period mentioned above, if another red line, or part of a red line, does not appear in any of the segments containing an abbreviation code for a testable drug group, the test has resulted in a Step 1 screening negative. Ignore any line or part of a line that FIRST appears after 10 minutes have elapsed. But do not ignore any line or part of a line that first appears BEFORE 10 minutes have elapsed EVEN IF it goes on developing until 12 minutes have elapsed.
•   If the test has resulted in a Step 1 screening negative testing is complete at that point and Step 2 is not required.
•   However, if, after the further time but still within the 10 minute period as mentioned above, another red line or part of a red line DOES appear in any of the segments containing an abbreviation code for a testable drug group, the test has resulted in a Step 1 screening positive.
•   Step 2 of the initial drug test is then to commence.
Definitions
For the purpose of preparing body samples for Step 1:
part of a red line includes a red line that is faint, interrupted or irregular.
Note   This is the kind of line that having appeared in some form BEFORE 10 minutes have elapsed, may go on developing until 12 minutes have elapsed.
testable drug group means the pharmacological grouping into which particular testable drugs fall, namely, the amphetamine group, the cannabis group, the cocaine group, and the opiates group.

1(b)
For the conduct of Step 2 of an initial drug test using the DrugWipeÒ 5+ approved drug testing device in association with the Cozart DDS approved drug testing device
Step 2 — Taking body samples with the Cozart DDS testing device (the device):
The approved tester is to ask the donor to hold and actively swab the bud-end of a Cozart Oral Swab around the gums and tongue and inside the cheeks of the donor, then leave the swab under the tongue until the sample presence indicator on the swab turns completely blue to indicate that a sufficient sample has been obtained.
Preparing body samples:
Once a sufficient sample has been obtained, the approved tester is to:
•   remove the lid from a sample buffer bottle and place the Cozart Oral Swab into the bottle, bud‑end first
•   snap the stem of the Cozart Oral Swab by gently bending it at the scored break-point
•   replace the lid on the sample buffer bottle and tighten it
•   mix the contents of the sample buffer bottle by gently but repeatedly inverting it for 30 seconds
•   ensure that the Cozart DDS device is ready to begin a new test
•   open the lid of the sample buffer bottle
•   hold the bottle vertically, apply 4 drops of fluid from the sample buffer bottle on to the sample well of the Cozart DDS test cartridge to be used with the Cozart DDS device
•   close the lid of the sample buffer bottle
•   after a period of not longer than 30 seconds, the fluid must appear on each of the 4 white membrane strips of the Cozart DDS cartridge. When the fluid appears, insert the cartridge into the Cozart DDS device with the arrow facing upwards
•   analysis of the sample is then underway
•   when analysis is completed, the result will be displayed on the screen of the device and a hardcopy printout will also be produced
•   if the result of the analysis is negative for all testable drug groups, the test has resulted in a Step 2 screening negative
•   the result of the initial drug test is, therefore, not a positive test result and testing is complete at that point
•   however, if the result of the analysis is positive for any testable drug group, the test has resulted in a Step 2 screening positive for that testable drug group
•   the result of the initial drug test is, therefore, a positive test result:
(a)    for 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;
and the tester is to proceed to the procedures in item 2 or 3 as the case may be.
Definition
For the purpose of preparing body samples for Step 2:
testable drug group means the pharmacological grouping into which particular testable drugs fall, namely, the amphetamine and methamphetamine group, the
cannabis group, the cocaine group, and the opiates group.

1
 
 

3          Schedule 4, clause 1
            omit
in accordance with Table 1.
            insert
in accordance with Table 1 and Table 2.
4          Schedule 4, clause 1, Table 1
            substitute
TABLE 1         DrugWipeÒ 5+
Activity
Procedures

Storing
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
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.

Maintaining
Maintenance is not required as the device is a one-use only device and is disposed of after use.

Operating
In a manner not inconsistent with the manufacturer’s instructions for operating the device.

TABLE 2         Cozart DDS
Activity
Procedures

Storing
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
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.

Maintaining
In a manner not inconsistent with the manufacturer’s instructions for maintaining the device, provided that:
•   compliance with any action recommended in those instructions is to be regarded as mandatory
•   inspection, cleaning, recalibration and other maintenance is to be carried out by Cozart plc, or another person approved by it, at least once every 12 months
•   any necessary repairs are to be undertaken by Cozart plc or another person approved by it.

Operating
In a manner not inconsistent with the manufacturer’s instructions for operating the device, provided that:
•   compliance with any action recommended in those instructions is to be regarded as mandatory
•   Cozart DDS 801 drug testing cartridges are to be used
•   each test result is to be printed out.

5          Schedule 6, clause 1, Table 1, item 1
            omit
The approved tester must first ask the donor if they have had anything to eat or drink in the preceding 10 minutes.
If the donor advises that he or she has had something to eat or drink in the preceding 10 minutes, the approved tester must request the donor to remain in the tester’s presence and not eat or drink anything further until the testing, including confirmatory testing if necessary, is completed.
If the donor has advised the approved tester that he or she has had something to eat or drink in the preceding 10 minutes, the approved tester must wait until at least 10 minutes have elapsed since the person had eaten or drank.
            insert
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.
6          Schedule 6, clause 1, Table 1, item 1
            omit
Provided that the donor has not had anything to eat or drink in the preceding 10 minutes, the approved tester must then ask the donor to remove the protective cellophane packaging and provide a sample of the donor’s breath.
            insert
Provided that the donor has not consumed anything containing alcohol in the preceding 10 minutes, the approved tester must then ask the donor to remove the protective cellophane packaging and provide a sample of the donor’s breath.
7          Schedule 6, clause 1, Table 1, item 2
            omit
The approved tester must first ask the donor if they have had anything to eat or drink in the preceding 10 minutes.
If the donor advises that he or she has had something to eat or drink in the preceding 10 minutes, the approved tester must request the donor to remain in the tester’s presence and not eat or drink anything further until the confirmatory testing is completed.
If the donor has advised the approved tester that he or she has had something to eat or drink in the preceding 10 minutes, the approved tester must wait until at least 10 minutes have elapsed since the person had eaten or drank.
            insert
If the approved tester has reason to believe that the donor may have consumed something containing alcohol since giving the initial sample, the tester may either:
    (a)   inform the donor that he or she is considered to have refused or failed to have given a body sample; or
Note   The consequences of a refusal or failure to provide a body sample are set out in regulation 99.335 of CASR 1998.
    (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.
8          Schedule 6, clause 1, Table 1, item 2, dot point 9
            omit
provided that the donor has not had anything to eat or drink in the preceding 10 minutes, the approved tester must then 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;
            insert
provided that the donor has not consumed anything containing alcohol in the preceding 10 minutes, the approved tester must then 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;