Explanatory Statement
Civil Aviation Safety Regulations 1998
Exemption of DAMP organisations for collection and screening of specimens
Purpose
This instrument modifies and replaces a previous instrument (CASA EX27/09). It adjusts the scope of the exemption of some persons who conduct drug tests under drug and alcohol management plans (DAMPs), from having to meet certain training and other requirements of the Standard for drug testing provided they meet particular conditions.
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 of CASR 1998, 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 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 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.
Training requirements under the oral fluid and urine Standards
Clause 1.3.13 of AS 4760 for oral fluids testing, 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 provides that on-site testing for oral fluids shall be performed by a technician from an accredited collecting agency. Clause 1.3.38 of AS 4760 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 AS 4308 for urine testing defines on-site screening as a screening test carried out at the point of collection. Clause 1.3.32 defines a screening test as a method used to exclude the presence of a drug or class of drugs and to identify whether specimen integrity has been compromised. Collection for this purpose is done by a collector.
Clause 1.3.14 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.
Collecting agency requirements under the urine Standard
Clause 1.3.12 of AS 4308 defines a collecting agency as 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.
Under clause 2.2.5 of AS 4308, personnel not authorised by a collecting agency are not permitted to be in any part of a collecting site where a donor provides a specimen of urine or where such a specimen is stored.
Under Appendix A of AS 4308, on-site screening procedures are described, including the role of a collecting agency.
AS 4308 is established in such a way that, to conform to the standard, collection and testing of urine specimens can only be performed by a collector who is an employee of, or similarly associated with, a collecting agency.
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 relevant Standard 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 specimen collection and on-site 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 one of the major Australian cities where training courses may periodically be run, and the DAMP organisation in turn establishing 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, though 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 equivalent, or near-equivalent, tester training, and use of proven highly reliable urine testing equipment and, thereby, protect the integrity of DAMP organisations’ drug testing.
Effect of exemption and conditions
First, a DAMP organisation may use a trained collector, meaning a person who has successfully completed a course of instruction in the oral fluid standard or the urine standard (as applicable for the test conducted). A course of instruction means, in effect, an accredited course within the Australian Quality Training Framework or the New Zealand Qualification Authority. Such a fully trained collector is, in effect, exempt from the requirements of AS 4308 for the role and involvement of a collecting agency. However, if conducting on-site screening of urine specimens, the trained collector must use one of 7 named devices, namely:
(a) Thermo Fisher Scientific MicroCup MultiDrug;
(b)SureStep OneStep Multi-Line Screen Test Panel with Integrated E-Z Split Key Cup;
(c)i-Screen OneStep Drug Screen Test Card;
(d)SureStep OneStep Drug Screen Test Cassette;
(e)Varian OnSite CupKit Pro5-AS;
(f)SureStep MultiDrug OneStep Multi Line Screen Test;
(g)Microcheck 6 cassette.
Secondly, a DAMP organisation may use a doctor or a nurse who has NOT completed a course of instruction, provided he or she has current professional responsibility (in a hospital, general practice or pathology service) in relation to the collection, storage, handling and despatch of biological specimens. Such a doctor or nurse is, in effect, also exempt from the requirements of AS 4308 for the role and involvement of a collecting agency. However, if conducting on-site screening of urine specimens, the doctor or nurse must use one of the 7 named devices.
Thirdly, if such a doctor or nurse, or a trained collector, is not available because of the remoteness of the location of the DAMP organisation at which testing is conducted, the testing may be done by another person (a capable person) who has been trained by a doctor, nurse, trained collector, or by another person who has completed some formal training in the collection, storage, handling and despatch of biological specimens. (A Note explains that formal training acceptable to CASA includes training given by a university, an institute of technology, a technical and further education college or a similar State or Territory institution as part of an accredited training course.)
A capable person may not test unless he or she has first affirmed in writing to CASA that he or she has been trained, giving details of the identity and qualifications of the trainer and a description of the training given.
A capable person is, in effect, also exempt from the requirements of AS 4308 for the role and involvement of a collecting agency. However, if conducting on-site screening of urine specimens, the capable person must use one of the 7 named devices.
The DAMP organisation must report to CASA, for each DAMP reporting period, on the numbers and locations of tests where trained collectors, doctors, nurses or capable persons, acted under the exemption. Reporting periods end immediately before 1 March and 1 September each year.
A DAMP organisation’s testing will be subject to periodic CASA audit to confirm its reliability and the competence of the DAMP testers who are used. The exemption applies only to DAMP testers under Subpart 99.B of CASR 1998. It does not apply to approved testers in CASA’s random drug testing program under Subpart 99.C of CASR 1998. 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 for the predecessor exemption (CASA EX27/09) was undertaken in 2009 with the Australian Aerial Agricultural Association (AAAA) and with representatives of larger airlines. The refinements now made to the exemption follow consultation with the National Association of Testing Authorities (NATA). The exemption is beneficial in that it modifies what would otherwise prove to be impractical aspects of the testing regime for DAMP organisations in remote and regional Australia in particular, but with conditions to ensure an acceptable level of testing quality control.
Office of Best Practice Regulation
The exemption is beneficial in effect by relieving of an obligation to comply with certain aspects of the DAMP testing requirements. 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
Following registration, the instrument commences on 23 September 2010, immediately after expiry of the predecessor it modifies (CASA EX27/09). The exemption stops having effect at the end of 22 September 2011. This is, in effect, a 1 year trial of the new arrangements provided for in the exemption, which will be reviewed for effectiveness and other implications towards the end of the period.
The exemption has been made by the Deputy Director of Aviation Safety, a delegate of CASA, under subregulation 7 (1) of CAR 1988.
[Instrument number CASA EX82/10]
ATTACHMENT 1
Details of exemption
1 Duration
Under this section, the instrument commences on 23 September 2010 and stops having effect at the end of 22 September 2011.
2 Definitions
Under this section, various words and phrases used in the exemption are defined as follows:
capable person means a person who, before conducting oral fluid testing or urine testing for drugs:
(a) affirms in writing to CASA that he or she:
(i) has completed training in oral fluid testing or urine testing (the training); and
(ii) has demonstrable competency in such testing; and
(b) includes in the affirmation:
(i) the name, address and qualifications of the person who gave the training; and
(ii) a description of the training.
collecting agency means an organisation assuming professional, organisational, educational and administrative responsibility for collection, on-site screening, storage and despatch of urine specimens.
collection means on-site collection, storage, handling and, if necessary, despatch, of oral fluid or urine specimens.
course of instruction, for a trained collector, means a course of instruction, in compliance with the oral fluid standard or the urine standard, that:
(a) is for specimen collection, on-site screening, handling, storage and despatch of specimens; and
(b) results in the trained collector’s receipt of a statement of attainment for the course in accordance with the Australian Quality Training Framework or the New Zealand Qualification Authority.
doctor means a State or Territory registered medical practitioner whose medical duties include the collection, storage, handling and despatch of biological specimens in 1 of the following:
(a) a hospital;
(b) a general practice;
(c) a pathology practice.
nurse means a State or Territory registered or enrolled nurse whose nursing duties include the collection, storage, handling and despatch of biological specimens in 1 of the following:
(a) a hospital;
(b) a general practice;
(c) a pathology practice.
on-site means the place at which an oral fluid or urine specimen is collected.
oral fluid standard means the relevant Standard, AS 4760, Procedures for specimen collection and the detection and quantitation of drugs in oral fluid, mentioned in paragraph (c) of the definition of relevant Standard in subregulation 99.010 (1) of CASR 1998.
screening means testing of a specimen to exclude the presence of drugs.
trained collector means a person who has successfully completed a course of instruction in the oral fluid standard or the urine standard.
training, for a capable person, means training by a person who is:
(a) a doctor or a nurse; or
(b) a trained collector under the oral fluid standard or the urine standard, as the case requires; or
(c) another person who has successfully completed formal training, acceptable to CASA, in the collection, on-site screening, storage, handling and despatch of biological specimens.
Note Formal training acceptable to CASA includes training given by a university, an institute of technology, a technical and further education college or a similar State or Territory institution as part of an accredited training course.
urine standard means the relevant Standard, AS/NZS 4308, Procedures for specimen collection and the detection and quantitation of drugs of abuse in urine, mentioned in paragraph (d) of the definition of relevant Standard in subregulation 99.010 (1) of CASR 1998.
3 Application to a DAMP organisation’s DAMP
Under this section, the instrument applies to collection and screening of drugs under the drug and alcohol management plan (DAMP) of a DAMP organisation.
A Note explains that a DAMP organisation is one to which regulation 99.030 of CASR 1998 applies.
4 Exemption — oral fluid or urine specimen collection and testing for drugs
Under this section, the DAMP organisation’s DAMP is exempt from compliance with subparagraphs 99.050 (1) (a) (ii) and (iii) of CASR 1998 to the extent mentioned in section 5.
A Note explains that subparagraphs 99.050 (1) (a) (ii) and (iii) impose requirements for oral fluid testing and urine testing to be in accordance with their respective relevant Standards.
5 Extent of exemption — collecting agency and course of instruction
Under this section, the extent of the exemption in section 4 is explained.
If the DAMP organisation is using a trained collector, the exemption exempts from the requirements, expressly or impliedly specified in the oral fluid standard or the urine standard, as the case requires, for the role or involvement of a collecting agency.
A Note explains that this is the only exemption in the instrument applicable to a DAMP organisation’s trained collector, and it applies for oral fluid or urine only if the trained collector has completed the course of instruction for oral fluid or urine as the case requires.
If the DAMP organisation is using a doctor, nurse or capable person, the exemption exempts first, from the requirement that the doctor, nurse or capable person must have successfully completed a course of instruction under the oral fluid standard or the urine standard (the applicable standards); and secondly from the requirements, expressly or impliedly specified in the applicable standards, for the role or involvement of a collecting agency.
6 Conditions on exemption
Under this section, the various conditions to which the exemption is subject are set out as follows:
(1)the DAMP organisation may only use the following persons for oral fluid collection, urine collection or urine screening:
(a) a trained collector trained for oral fluid, urine or both, as the case requires; or
(b) a doctor, a nurse, or, subject to subsections (3) and (4), a capable person.
(2) A trained collector, a doctor or a nurse may only conduct on-site screening of a urine specimen if he or she uses 1 of the following devices for the test:
(a) Thermo Fisher Scientific MicroCup MultiDrug;
(b) SureStep OneStep Multi-Line Screen Test Panel with Integrated E-Z Split Key Cup;
(c) i-Screen OneStep Drug Screen Test Card;
(d) SureStep OneStep Drug Screen Test Cassette;
(e) Varian OnSite CupKit Pro5-AS;
(f) SureStep MultiDrug OneStep Multi Line Screen Test;
(g) Microcheck 6 cassette.
(3) A capable person may only collect oral fluid or urine specimens if a trained collector, a doctor or a nurse is not reasonably available to do the collection because of the remoteness of the location of the DAMP organisation.
(4) A capable person may only conduct on-site screening of a urine specimen if:
(a) a trained collector, a doctor or a nurse is not reasonably available to do the screening because of the remoteness of the location of the DAMP organisation; and
(b) the capable person uses 1 of the devices mentioned in subsection 6 (2).
(5) The DAMP organisation for whom a trained collector, a doctor, a nurse or a capable person collects or screens specimens must report the following in writing to CASA for each DAMP reporting period:
(a) the number of occasions on which the particular person has done collection or screening;
(b) where each occasion of collection or screening occurred.
(6) The report mentioned in subsection (5) must be included with the information provided to CASA by the DAMP organisation under regulation 99.100 of CASR 1998 for each reporting period, defined in regulation 99.010 as the period of 6 months immediately before 1 March and 1 September.