EXPLANATORY STATEMENT
Select Legislative Instrument 2009 No. 187
Issued by the Authority of the Minister for Home Affairs
Customs Act 1901
Customs (Prohibited Imports) Amendment Regulations 2009 (No. 3)
Customs (Prohibited Exports) Amendment Regulations 2009 (No. 1)
Section 270 of the Customs Act 1901 (the Customs Act) provides, in part, that the Governor‑General may make regulations not inconsistent with the Customs Act prescribing all matters necessary or convenient to give effect to the Customs Act.
Sections 50 and 112 of the Customs Act provide, in part, that the Governor-General may, by regulation, prohibit the importation or exportation of goods into or from Australia. These powers may be exercised by prohibiting the importation or exportation of goods absolutely, or by prohibiting the importation or exportation of goods unless specified conditions or restrictions are complied with.
The Customs (Prohibited Imports) Regulations 1956 (the PI Regulations) and the Customs (Prohibited Exports) Regulations 1958 (the PE Regulations) control the importation and exportation, respectively, of the goods specified in the various regulations and Schedules.
The amending Regulations amend the PI Regulations and PE Regulations to prohibit, without permission, the importation and exportation of viable material derived from human embryo clones.
The amending Regulations satisfy the obligation in section 23C of the Prohibition of Human Cloning for Reproduction Act 2002 (PHCR Act). Section 23C requires the Minister who administers the Customs Act to take all reasonable steps to ensure that regulations are made that permit, subject to appropriate conditions or restrictions, the importation and exportation of human embryonic stem cell lines which have been derived from human embryo clones using practices consistent with Australian legislation.
Section 23C of the PHCR Act was inserted into the PHCR Act by the Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Act 2006. Section 23C gives effect to recommendation 42 of the Legislation Review Committee chaired by the late John S Lockhart AO QC, which states that the importation and exportation of ethically derived viable material from human embryo clones should be permitted after approval had been obtained from an appropriate authority.
The amending Regulations add new provisions to the PI Regulations and the PE Regulations prohibiting the importation and exportation, respectively, of viable material derived from human embryo clones unless the Minister who administers the PHCR Act, or a person authorised by that Minister, has given permission.
The amending Regulations also introduce provisions with allow for:
— the revocation of a permission under certain circumstances;
— conditions to be imposed on the import or export permission; and
— the review of decisions made in relation to an application.
Difficulties in formulating an appropriate import and export control for goods which do not currently exist, and the complexity of the science involved, has resulted in the amending Regulations being delayed. As there are no goods to which the import and export control currently apply, the delay in having the amending Regulations made has had no material effect.
Details of the amending Regulations which amend the PI Regulations are outlined at Attachment A.
Details of the amending Regulations which amend the PE Regulations are outlined at Attachment B.
The amending Regulations were developed in consultation with the National Health and Medical Research Council. As the amending Regulations give effect to section 23C of the PHCR Act, no further consultation was undertaken.
The amending Regulations commence on the day after they are registered on the Federal Register of Legislative Instruments.
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ATTACHMENT A
DETAILS OF THE CUSTOMS (PROHIBITED IMPORTS) AMENDMENT REGULATIONS 2009 (No. 3)
Regulation 1 - Name of Regulations
This regulation provides that the title of the amending Regulations is the Customs (Prohibited Imports) Amendment Regulations 2009 (No. 3).
Regulation 2 - Commencement
This regulation provides that the amending Regulations commence on the day after they are registered on the Federal Register of Legislative Instruments.
Regulation 3 - Amendment of Customs (Prohibited Imports) Regulations 1956
This regulation provides that the Customs (Prohibited Imports) Regulations 1956 (the PI Regulations) are amended as set out in Schedule 1 to the amending Regulations.
SCHEDULE 1 - AMENDMENTS
Item [1] - Regulation 2, definition of human embryo clone
This item omits the definition of human embryo clone from regulation 2 of the PI Regulations. As a consequence of the amending Regulations, the term human embryo clone only appears in new regulation 5L of the PI Regulations. A new definition for human embryo clone is contained in new regulation 5L of the PI Regulations.
Item [2] - Regulation 2, definition of viable material
This item omits the definition of viable material from regulation 2 of the PI Regulations. As a consequence of the amending Regulations, the term viable material only appear in new regulation 5L of the PI Regulations. The existing definition for viable material is replicated in new regulation 5L of the PI Regulations.
Item [3] - After regulation 5K
This item inserts a new regulation 5L into the PI Regulations. New regulation 5L prohibits, without permission, the importation into Australia of viable material derived from human embryo clones.
New subregulation 5L(1) defines the following four terms used in new regulation 5L:
a) authorised person means a person authorised in writing by the Minister who administers the Prohibition of Human Cloning for Reproduction Act 2002 (PHCR Act);
b) human embryo clone has the same meaning as in section 8 of the PHCR Act. Section 8 of the PHCR Act defines human embryo clone to mean "a human embryo that is a genetic copy of another living or dead human, but does not include a human embryo created by the fertilisation of a human egg by human sperm";
c) Minister means the Minister administering the PHCR Act; and
d) viable material has the meaning living tissues and cells.
The note at the end of new subregulation 5L(1) provides that to determine the Minister administering the PHCR Act, regard is to be had to the latest Administrative Arrangements Order.
New subregulation 5L(2) prohibits the importation of viable material derived from human embryo clones unless permission in writing to import the good has been granted by the Minister who administers the PHCR Act (or a person authorised in writing by that Minister), and the written permission is produced to the Collector at or before the time of importation. 'Collector' is defined in subsection 8(1) of the Customs Act 1901 (the Customs Act) to mean the Chief Executive Officer of Customs, the Regional Director of a State or Territory or any officer doing duty in the matter in relation to which the expression is used.
New subregulation 5L(3) enables the Minister or an authorised person to specify conditions or requirements, including times for compliance, which must be complied with by the holder of the permission.
New subregulation 5L(4) gives the Minister or an authorised person the power to revoke a permission were the holder does not comply with a condition or requirement specified under new subregulation 5L(3). New subregulation 5L(4) also provides that the revocation must be in writing.
New subregulation 5L(5) makes it clear that the power of revocation is not limited to circumstances where the holder has been charged with an offence under subsection 50(4) of the Customs Act for not complying with the condition or requirement. Subparagraph 50(3)(b)(iv) of the Customs Act provides that the regulations may make provision for the revocation of a permission that is granted subject to a condition or requirement, whether or not the holder of the permit is charged with an offence against subsection 50(4) of the Customs Act.
New subregulation 5L(6) provides for independent review by the Administrative Appeals Tribunal of certain decisions made under new regulation 5L. Those decisions are a decision by the Minister or the authorised person not to grant a permission to import the good, to grant a permission specifying a condition or requirement, or to revoke a permission to import the good.
New subregulation 5L(7) provides that the notice of the decision not to grant a permission, grant a permission with conditions or requirements, or to revoke a permission, must include a statement that the person affected by the decision can seek review of that decision and the person may request a statement under section 28 of the Administrative Appeals Act 1975.
New subregulation 5L(8) provides that the failure to comply with new subregulation 5L(7), which relates to including in a decision a statement that the person affected by the decision can seek review, does not affect the validity of the decision.
Item [4] - Schedule 1, item 27
This item omits item 27 from Schedule 1 to the PI Regulations. Item 27 prohibits absolutely the importation of viable material derived from human embryo clones. The removal of item 27 allows, subject to a permission being granted under new regulation 5L (see Item [3] above), viable material derived from human embryo clones to be imported into Australia.
ATTACHMENT B
DETAILS OF THE CUSTOMS (PROHIBITED EXPORTS) AMENDMENT REGULATIONS 2009 (No. 1)
Regulation 1 - Name of Regulations
This regulation provides that the title of the amending Regulations is the Customs (Prohibited Exports) Amendment Regulations 2009 (No. 1).
Regulation 2 - Commencement
This regulation provides that the Regulations commence on the day after they are registered on the Federal Register of Legislative Instruments.
Regulation 3 - Amendment of Customs (Prohibited Exports) Regulations 1958
This regulation provides that the Customs (Prohibited Exports) Regulations 1958 (the PE Regulations) are amended as set out in Schedule 1 to the Regulations.
SCHEDULE 1 - AMENDMENTS
Item [1] - Regulation 2, definition of human embryo
This item substitutes the definition of human embryo in regulation 2 of the PE Regulations with a definition for the term human embryo clone. As a consequence of the amending Regulations, the term human embryo is no longer used in the PE Regulations. For the purposes of the PE Regulations, the term human embryo clone has the meaning given to that term by section 8 of the Prohibition of Human Cloning for Reproduction Act 2002 (PHCR Act). The term is defined in section 8 of the PHCR Act to mean "a human embryo that is a genetic copy of another living or dead human, but does not include a human embryo created by the fertilisation of a human egg by human sperm".
Item [2] - After regulation 8
This item inserts a new regulation 8A into the PE Regulations. New regulation 8A prohibits, without permission, the exportation from Australia of viable material derived from human embryo clones.
New subregulation 8A(1) defines the following three terms used in regulation 8A:
a) authorised person means a person authorised in writing by the Minister who administers the Prohibition of Human Cloning for Reproduction Act 2002 (PHCR Act);
b) Minister means the Minister administering the PHCR Act; and
c) viable material has the meaning living tissues and cells.
The note at the end of new subregulation 8A(1) provides that to determine the Minister administering the PHCR Act, regard is to be had to the latest Administrative Arrangements Order.
New subregulation 8A(2) prohibits the exportation of viable material derived from human embryo clones unless permission in writing had been granted by the Minister who administers the PHCR Act (or a person authorised in writing by that Minister), and the written permission is produced to the Collector at or before the time of exportation. 'Collector' is defined in subsection 8(1) of the Customs Act 1901 (the Customs Act) to mean the Chief Executive Officer of Customs, the Regional Director of a State or Territory or any officer doing duty in the matter in relation to which the expression is used.
New subregulation 8A(3) enables the Minister or an authorised person to specify conditions or requirements, including times for compliance, which must be complied with by the holder of the permission.
New subregulation 8A(4) gives the Minister or an authorised person the power to revoke a permission were the holder does not comply with a condition or requirement specified under new subregulation 8A(3). New subregulation 8A(4) also provides that the revocation must be in writing.
New subregulation 8A(5) makes it clear that the power of revocation is not limited to circumstances where the holder has been charged with an offence under subsection 112(2B) of the Customs Act for not complying with the condition or requirement. Subparagraph 112(2A)(b)(iv) of the Customs Act provides that the regulations may make provision for the revocation of a permission that is granted subject to a condition or requirement, whether or not the holder of the permit is charged with an offence against subsection 112(2B) of the Customs Act.
New subregulation 8A(6) provides for independent review by the Administrative Appeals Tribunal of certain decisions made under regulation 8A. Those decisions are a decision by the Minister or the authorised person not to grant a permission to export the good, to grant a permission specifying a condition or requirement, or to revoke a permission to export the good.
New subregulation 8A(7) provides that the notice of the decision not to grant a permission, grant a permission with conditions or requirements, or to revoke a permission, must include a statement that the person affected by the decision can seek review of that decision and the person may request a statement under section 28 of the Administrative Appeals Act 1975.
New subregulation 8A(8) provides that the failure to comply with new subregulation 8A(7), which relates to including in a decision a statement that the person affected by the decision can seek review, does not affect the validity of the decision.
Item [3] - Schedule 6, item 1
This item substitutes item 1 of Schedule 6 to the PE Regulations. Schedule 6 sets out those goods to which regulation 8 of the PE Regulations apply. Under regulation 8, the permission of the Secretary to the Department of Health and Ageing, or a person authorised by the Secretary, must be obtained before goods included in Schedule 6 can be exported. Item 1 of Schedule 6 currently prohibits, without permission being obtained under regulation 8, the exportation of human body fluids, organs and other tissues, including a part or constitute of material of that kind, if the internal volume of the immediate container in which the material is packed exceeds 50ml. This includes viable material derived from human embryo clones.
New item 1 of Schedule 6, excludes from item 1 of Schedule 6, and therefore the requirement to obtain an export permission under regulation 8 of the PE Regulations, viable material derived from human embryo clones. The exportation of viable material derived from human embryo clones is now controlled under new regulation 8A of the PE Regulations.
New item 1 of Schedule 6 also removes references to repealed regulation 7. Regulation 7 of the PE Regulations was repealed on 12 June 2007 by the Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Act 2006.