Biosecurity (Human Health) Regulation 2016 [F2016L00719]-Response required [2016] AUSStaCSDLM 169 (14 September 2016)

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Instrument	Biosecurity (Human Health) Regulation 2016 [F2016L00719]
Purpose	Sets requirements for preventing and managing biosecurity risks to human health
Last day to disallow	21 November 2016
Authorising legislation	Biosecurity Act 2015
Department	Health
Scrutiny principle	Standing Order 23(3)(a) and (b)

Incorporation of documents^[1]

Section 14 of the Legislation Act 2003 allows legislative instruments to make provision in relation to matters by incorporating Acts and disallowable legislative instruments, either as in force at a particular time or as in force from time to time. Other documents may only be incorporated as in force at the commencement of the legislative instrument, unless authorising or other legislation alters the operation of section 14.

With reference to the above the committee notes that various sections of the regulation incorporate the Biosecurity (Movements between Parts of Australian Territory) Declaration 2016 (the movements declaration), which is made under subsection 618(2) of the Biosecurity Act 2015 (the Biosecurity Act). However, neither the text of the regulation nor the ES expressly states the manner in which the declaration is incorporated.

The committee further notes that subsection 618(7) of the Biosecurity Act provides that the movements declaration is a legislative instrument that is not subject to disallowance (an exempt instrument). Subsection 14(3) of the Legislation Act 2003 provides that only disallowable legislative instruments may be incorporated as in force from time to time. The committee therefore understands that the movements declaration may only be incorporated as in force at the commencement of the regulation, unless authorising or other legislation alters the operation of section 14.

However, the committee expects instruments (and ideally their accompanying ESs) to clearly state the manner in which exempt instruments are incorporated (that is, either as in force from time to time or as in force at the commencement of the legislative instrument). This enables persons interested in or affected by the instrument to understand its operation without the need to rely on specialist legal knowledge or advice, or consult extrinsic material.

The committee requests the advice of the minister in relation to this matter.

Drafting

The regulation sets requirements for taking and storing body samples. It requires that samples 'must be taken in a manner consistent with appropriate medical samples' and 'must be stored, transported, labelled and used in a manner consistent with appropriate professional standards that are relevant to managing the risks to human health of listed human diseases.' Failure to comply with these requirements is an offence under subsection 10(5) of the regulation.

The committee is concerned that the terms 'appropriate medical standards' and 'appropriate professional standards' are insufficiently precise, such that it may be difficult for a person to know what standards must be complied with to ensure that they do not commit an offence under the regulation. This uncertainty in the application of the offence is problematic in terms of the committee's task of ensuring that the exercise of the Parliament's delegated legislative powers does not trespass unduly on personal rights and liberties (scrutiny principle 23(3)(b)).

Further, the taking and storing of body samples must be subject to clear and appropriate safeguards in order to avoid undue tresspass on personal rights and liberties (namely the right to privacy). Without more specific information regarding the medical or professional standards with which officers must comply when taking or storing body samples, the committee is unable to satisfy itself that the regulation will not trespass unduly on an individual's rights and liberties.

The committee requests the advice of the minister in relation to this matter.

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[1] The committee notes that this comment raises an identical issue to that raised in relation to Biosecurity Charges Imposition (Customs) Regulation 2016 [F2016L00723]; and Biosecurity Charges Imposition (General) Regulation 2016 [F2016L00727]. See p. 5 of this monitor.