Quarantine Legislation Amendment (2014 Measures No. 2) Proclamation 2014

EXPLANATORY STATEMENT

Issued by Authority of the Minister for Agriculture

Quarantine Act 1908

Quarantine Legislation Amendment (2014 Measures No. 2) Proclamation 2014

Legislative Authority

Section 13 of the Quarantine Act 1908 provides that the Governor-General may, by proclamation, declare or prohibit a range of matters for the purposes of the Act. These matters include prohibiting the introduction or importation into Australia of: any disease or pest or any substance; any animals or plants, or parts of animals or plants; any articles or things containing or likely to contain any disease or pest; any articles or things that are likely to introduce, establish or spread any disease or pest; and appointing places on land or sea to be quarantine stations for the performance of quarantine.

Subsection 13(2) of the Act provides that the power of prohibition extends to absolute prohibition or prohibition subject to specified conditions or restrictions.

Subsection 13(2A) of the Act provides that a proclamation made under subsection 13(1) of the Act may provide that the importation of a thing is prohibited unless a permit for its import is granted by a Director of Quarantine.

The Quarantine Proclamation 1998 (Quarantine Proclamation) provides the legislative basis for controlling the entry of animals, plants and other goods of quarantine concern into mainland Australia (including from Christmas Island and Cocos (Keeling) Islands).

The Quarantine (Christmas Island) Proclamation 2004 (Christmas Island Proclamation) and the Quarantine (Cocos Islands) Proclamation 2004 (Cocos Islands Proclamation) provide the legislative basis for controlling the entry of animals, plants and other goods of quarantine concern into Christmas Island and Cocos (Keeling) Islands.

Purpose

The purpose of the Quarantine Legislation Amendment (2014 Measures No. 2) Proclamation 2014 (Amendment Proclamation) is to:

• more accurately align regulatory controls affecting imports of low risk biological goods with the level of biosecurity risk associated with their importation;
• update the species of seeds in Schedule 5 to the Quarantine Proclamation that may be imported into mainland Australia without a permit;
• remove reference to the now closed Byford quarantine station; and
• fix typographical errors and remove obsolete references.

Impact and Effect

The Amendment Proclamation will increase the number of low biosecurity risk commodities that can be imported without a permit into mainland Australia, Christmas Island and Cocos (Keeling) Islands. The amendments more accurately align the regulatory controls affecting imports of low risk biological goods with the level of biosecurity risk associated with the importation of these goods. The amendments also reduce costs for importers directly by removing fees for permit applications and assessments and streamlining the clearance process for these goods at the border.

The Amendment Proclamation will reduce regulatory burden for industry, businesses and individuals, particularly in the Indian Ocean Territories, making it easier to obtain commodities necessary for everyday use, such as food items and plant products.

The Amendment Proclamation will add 117 seed species to Schedule 5 to the Quarantine Proclamation. Schedule 5 lists all seed species which have been assessed by the Department as posing a level of risk that does not exceed Australia’s Appropriate Level of Protection (ALOP) in regards to their potential to introduce pests or diseases. Seed species listed as ‘permitted seeds’ in Schedule 5 may be imported into mainland Australia without an import permit and removing the requirement for an import permit for these species removes administrative, regulatory and cost burdens to importers associated with obtaining such a permit.

The Amendment Proclamation also omits one seed species from the permitted seeds list in Schedule 5 to the Quarantine Proclamation to reflect the assessment or reassessment of risk.  This seed species will require an import permit and will be subject to quarantine conditions as determined by the Director of Quarantine to manage the risks associated with importation.

Consultation

Import Condition database (ICON) notices will be published on the Department’s website prior to the commencement of the amendments to the Proclamation. ICON is a database where both departmental officers and the public can access information about Australian import requirements for a range of commodities.

Industry will be notified through the Biologicals Consultative Group (comprising industry representatives from peak bodies) and education on the new import mechanisms will be undertaken following approval of the amendments.

The Biologicals Consultative Group includes representatives of the:

• Animal Medicines Australia (previously Animal Health Alliance Australia)
• Association of Biosafety for Australia and New Zealand
• Association of Regulatory and Clinical Scientists
• Ausbiotech
• Australasian Plant Pathology Society
• Australian Pesticides and Veterinary Medicines Authority
• Australian Self-Medication Industry
• Complementary Medicines Australia (previously Complementary Healthcare Council of Australia)
• Council of Heads of the Australian Fauna Collection, Australian Museum
• Customs Brokers and Forwarders Council of Australia
• Department of Health
• Food and Beverage Importers Association
• Food Ingredients and Additives Association of Australia
• IVD Australia
• Medical Industry Association of Australia
• Medical Technology Association of Australia
• Pet Food Industry Association of Australia
• Queensland Alliance for Agriculture and Food Innovation
• Science Industry Australia
• Universities Australia
• Veterinary Manufacturers and Distributors Association

The Department met with businesses, residents, the Shire councils and other government agencies to discuss changes to the Christmas Island Proclamation and Cocos Islands Proclamation.

Addition and deletion of species in the list of permitted seeds in Schedule 5 of the Quarantine Proclamation occurs after formal assessment of the seeds by the Department. Species for addition are assessed following requests from industry and individuals who wish to import species not currently approved. Species which are identified as potential weed threats are assessed for deletion from the Schedule, and industry is notified accordingly through ICON alerts. Individuals that specifically requested assessment of a seed species are notified directly of amendments to be introduced as a result of the assessment.

The Office of Best Practice Regulation (OBPR) was consulted by the Department in relation to the realignment of regulatory process for a range of imported biological goods with the level of biosecurity risk, and the update of Schedule 5 (permitted seeds). OBPR confirmed that the amendments have no substantial direct or indirect impact on business or individuals in the community, and that a regulatory impact statement is not required (OBPR Reference Numbers 17194 and 17301).

The Amendment Proclamation is a legislative instrument for the purposes of the Legislative Instruments Act 2003. It is compatible with the human rights and freedoms recognised or declared under section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011. A full statement of compatibility is set out in the Attachment.

Details/Operation

Section 1 – Name of Proclamation

This section provides that the name of the Amendment Proclamation is the Quarantine Legislation Amendment (2014 Measures No. 2) Proclamation 2014.

Section 2 – Commencement

This section provides for the Amendment Proclamation to commence on 1 January 2015.

Section 3 – Authority

This section provides that the Amendment Proclamation is made under the Quarantine Act 1908.

Section 4 – Schedule(s)

This section provides that any instruments specified in a schedule to the Amendment Proclamation are repealed or amended as set out in the relevant schedule.

Schedule 1 – Quarantine Proclamation 1998

Items 1, 3, 6 and 8 repeal the definitions of ‘Christmas Island’, ‘Cocos Islands’, ‘Director of Quarantine’ and ‘Officer’ in section 3 of the Quarantine Proclamation and insert a note to refer to these definitions in the Quarantine Act.

The purpose of the amendments is to remove definitions from the Quarantine Proclamation which are set out in the Act and insert a note directing readers to the Act consistent with current drafting practice.

Item 2 inserts a definition of ‘biological material’ in section 3 of the Quarantine Proclamation.

The purpose of the amendment is to clarify the use of the term ‘biological material’ in the Quarantine Proclamation, which includes any material originating from an animal, plant or microbial source, as opposed to non-biological (semi-synthetic) material.

Item 4 repeals the definition of ‘DAFF FMD Approved Country List’ from section 3 of the Quarantine Proclamation.

The purpose of the amendment is to remove an outdated definition, which is replaced by a new definition that is inserted by item 5.

Item 5 inserts definitions of ‘dairy product’ and ‘Department of Agriculture FMD-Free Approved Country List’ in section 3 of the Quarantine Proclamation.

The purpose of the amendments is:

• to, along with the amendment that is made by item 30, move the definition of ‘dairy product’ from section 35 of the Quarantine Proclamation so that the term is defined for the whole of the Proclamation, rather than just for Part 6 as is currently the case; and
• to reflect the department’s name change and update the title of the Department of Agriculture FMD-Free Approved Country List (to more clearly represent the content of the list) consistent with current drafting practice.

Item 7 inserts definitions of ‘egg’ and ‘egg product’ in section 3 of the Quarantine Proclamation.

The purpose of the amendment is, along with the amendment that is made by item 30,  to move the definitions of ‘egg’ and ‘egg product’ from section 35(1) of the Quarantine Proclamation so that these terms are defined for the whole of the Proclamation, rather than just for Part 6, as is currently the case.

Item 9 inserts the definitions of ‘official veterinarian’, ‘shelf stable’ and ‘United Nations Convention on the Law of the Sea’ to section 3 of the Quarantine Proclamation.

The purpose of the amendment is to, along with the amendment that is made by items 30 and 31:

• provide the same meaning for ‘official veterinarian’ as in the updated reference to the Terrestrial Animal Health Code, produced by the World Organisation for Animal Health (OIE); and
• move the meaning of ‘shelf stable’ from subsection 35(3) of the Quarantine Proclamation so that this term is defined for the whole Proclamation, rather than just for Part 6 as is currently the case.

The amendment also defines ‘United Nations Convention on the Law of the Sea’, to reflect the term that is used in Division 3 of Part 4 of the Quarantine Proclamation which is inserted by item 23.

Items 10 and 11 repeal note 2 to section 3 of the Quarantine Proclamation and remove the identifying number from note 1 as a consequential amendment to the amendment that is made by item 1.

Item 12 inserts a new section 4A in the Quarantine Proclamation which provides for the meaning of ‘shelf stable’.

The purpose of the amendment, along with the amendments that are made by items 9 and 30, is to move the definition of ‘shelf stable’ from subsection 35(3) to a new section 4A of the Quarantine Proclamation to define the meaning of the term for the purposes of the whole Proclamation, rather than just for Part 6 as is currently the case.

Items 13 and 14 repeal paragraph 14(1)(i) of the Quarantine Proclamation and make a consequential amendment to paragraph 14(1)(g).

The purpose of the amendments is to remove the reference to the Byford quarantine station in Western Australia from the list of quarantine stations for animals or goods as it is no longer operational and reformat paragraph 14(1)(g) as a consequential amendment.

Item 15 inserts a definition of ‘veterinary therapeutic use’ in section 27 of the Quarantine Proclamation.

The purpose of the amendment is to set out the meaning of the term that is inserted by item 20, and to distinguish between veterinary food and therapeutic products.

Veterinary therapeutic use products are subject to regulatory requirements imposed by the Australian Pesticides and Veterinary Medicines Authority in which the Department of Agriculture can be confident that the claims and associated risks have been assessed. Veterinary food products are not subject to these requirements.

Item 16 substitutes item 23 of table 11 in section 27 of the Quarantine Proclamation with a new item 23.

The purpose of the amendment is to expand the list of microbial fermentation products that do not require an import permit for importation (lactic acid, citric acid, xanthum gum, purified vitamins or purified amino acids) as they are prolifically used in a range of commodities and have a low biosecurity risk because they have been highly purified.

The effect of the amendment is to better align regulatory control of the importation of these products with the associated biosecurity risk. Currently, the importation of microbial fermentation products (other than alcohols, vitamins and amino acids) is prohibited unless an import permit is granted. The amendment makes the description in item 23 more specific and expands the list of products that do not require an import permit to minimise regulatory burden on importers.

Item 17 substitutes the heading of Division 2 of Part 4 of the Quarantine Proclamation with a new heading as a consequential amendment to the amendment that is made by item 23.

Item 18 substitutes the heading of section 28 of the Quarantine Proclamation with a new heading as a consequential amendment to the amendment that is made by item 23.

Item 19 substitutes the reference to ‘section 29’ with ‘section 29, Division 3, or section 33’ in paragraph 28(2)(a) of the Quarantine Proclamation.

Section 28 of the Quarantine Proclamation provides that articles that are prohibited biological materials or contain prohibited biological material (set out tin table 11), or articles of which prohibited biological material is an ingredient cannot be imported unless an import permit has been granted. However, the import of certain articles are permitted without an import permit under paragraph 28(2)(a) if they are permitted under sections 29, 38, 39, 40, 41, 42, 43, 44 or 46 or not otherwise prohibited by the Quarantine Proclamation.

The purpose of the amendment is to insert a reference to section 33 and Division 3 (which is inserted in the Quarantine Proclamation by item 23) so that the biological materials listed in these provisions may be imported without an import permit.

Item 20 adds subsection 28(2)(e) and table 11AA to the Quarantine Proclamation.

The purpose of the amendment is to allow an article that:

• in normal use, is generally meant for human consumption, human therapeutic use or veterinary therapeutic use;
• is commercially prepared and packaged in a form that requires no further processing or repackaging before retail sale; and
• is a biological material listed in table 11AA and are not otherwise prohibited

to be imported without the requirement for an import permit to reflect the very low biosecurity risk associated with those articles (such as alcohol swabs and fish oil tablets).

Item 21 substitutes subsection 29(2) of the Quarantine Proclamation with a new subsection 29(2).

The purpose of the amendment is to allow substances or articles intended for human therapeutic use in a commercially prepared and packaged form (i.e. in a fully finished, retail ready form) to be imported without an import permit. This will recognise that there is no additional biosecurity risk associated with starter cultures intended for human therapeutic products as starter cultures intended for human food or beverages. Human therapeutic products are subject to specific regulatory controls concerning safety as administered by the Therapeutic Goods Administration.

Item 22 substitutes table 11A in section 29 of the Quarantine Proclamation with a new table 11A.

The purpose of the amendment is to update the list of substances or articles that are starter cultures or derivatives of starter cultures in table 11A that may be introduced or imported into mainland Australia without a permit. However, this will only be possible  if the substance or article is not contained in a milk-based carrier and is intended for the purposes set out in subsection 29(2) (e.g. human food or beverages or human therapeutic use).

The updated list of starter cultures was identified as a result of a review of permitted enzymes (and microbes that produce those enzymes) by Food Standards Australia New Zealand (FSANZ) against the Department’s current list of microbes for bioremediation use. The following additions to table 11A were identified where the two lists reference the same microorganism.

In practice, if FSANZ lists the microorganism then the Department may approve it for use and it should be appropriately identified as an approved starter culture for a specific end use in legislation.

The amendment also:

• removes existing table item 42 Streptococcus paracitrovirum, as this name is no longer referred to in laboratory use
• fixes a typographical error at existing table item 10 to read ‘Debaryomyces spp.’
• adds a synonym at existing table item 27 to read ‘Penicillium camemberti (also known as Penicillium camembertii)’
• adds a synonym at existing table item 28 to read ‘Penicillium roqueforti (also known as Penicillium roquefortii)’.

Item 23 adds Division 3 at the end of Part 4 to the Quarantine Proclamation.

The purpose of the amendment is to add a list of biological materials (certain animal food, teleost fish, and cephalopods and associated finfish bycatch) that may be imported into mainland Australia, subject to the conditions listed in the relevant provisions. The conditions reflect standard conditions already available in relation to these biological materials. This will minimise the regulatory burden on importers by exempting these products.

Item 24 substitutes the table and column headings of Table 12 in section 32 of the Quarantine Proclamation with new table and column headings to reflect current drafting practice.

Item 25 substitutes item 1 of table 12 in section 32 of the Quarantine Proclamation with a new item 1.

The purpose of the amendment is to amend the list of articles likely to introduce a pest or disease so that soil, articles with soil adhering and articles that contain soil are articles likely to introduce a pest or disease unless they are treated by an approved treatment on arrival.

The effect of the amendment is to reflect current practice, which is to exclude articles or things containing untreated soil from entering mainland Australia and allow soil, articles with soil adhering and articles containing soil treated in an approved way to enter mainland Australia.

The provision purposefully does not specify the treatment as it is expected that treatment methods will change over time. A standard list of treatments is maintained by the Department.

Item 26 substitutes item 7 of table 12, in section 32 of the Quarantine Proclamation with a new item 7.

The purpose of the amendment is to amend the list of articles likely to introduce a pest or disease so that foods or supplements for animals, of plant, animal (including fish) or microbial origin are articles likely to introduce a pest or disease unless the only ingredients of which are listed (e.g. alcohol or citric acid).

The effect of the amendment is to minimise regulatory burden on importers by exempting low biosecurity risk foods and supplements from permit requirements based on standard treatment processes that manage the biosecurity risk.

Item 27 substitutes item 25 of table 12, in section 32 of the Quarantine Proclamation with a new item 25.

The purpose of the amendment is to amend the list of articles likely to introduce a pest or disease so that bioremedial products are articles likely to introduce a pest or disease unless they are synthetic and chemical bioremedial products and those bioremedial products in which the only ingredients of biological origin are those listed (e.g. alcohol or citric acid).

The effect of the amendment is to minimise regulatory burden on importers by exempting low biosecurity risk bioremedial products from permit requirements based on standard treatment processes that manage biosecurity risk.

Item 28 inserts ‘or (3)’ after ‘subsection (2)’ in subsection 33(1) of the Quarantine Proclamation.

The purpose of the amendment is to also refer to new subsection 33(3) to be inserted by item 29.

The effect of the amendment is to ensure that articles or things permitted to be imported into mainland Australia under Division 3 of Part 4 are not prohibited by subsection 33(1).

Item 29 substitutes subsection 33(2) of the Quarantine Proclamation with new subsections 33(2) and 33(3).

The purpose of the amendment is to include reference to Division 3 of Part 4, also relating to teleost fish, as is introduced by item 23 for consistency.

The effect of the amendment is to ensure that subsection 33(1) applies to a teleost fish or a teleost fish product that is permitted to be imported under the listed provisions, and also an article or thing that is permitted to be imported under Division 3 of Part 4.

Item 30 repeals definitions of ‘dairy product’, ‘egg’, ‘egg product’ and ‘official veterinarian’ from subsection 35(1) of the Quarantine Proclamation.

The purpose of the amendment, along with the amendments that are made by items 5, 7 and 9, is to move the definitions to section 3 so they are defined for the purposes of the whole Proclamation rather than just for part 6 as is currently the case.

Item 31 repeals subsection 35(3) of the Quarantine Proclamation.

The purpose of the amendment, along with the amendments that are made by items 9 and 12, is to move the definition of ‘shelf stable’ so that this term is defined for the whole Proclamation, rather than just for Part 6 as is currently the case.

Item 32 amends item 1 of table 13 in section 38 of the Quarantine Proclamation to clarify the types of preserved animals and animal tissues (including fish) that do not require an import permit for importation into mainland Australia.

The new item allows preserved animals and animal tissues (including fish) to be imported into mainland Australia without an import permit if it is:

• preserved and fixed in 70% alcohol or 10% formalin or a minimum of 2% glutaraldehyde, or plastinated using curable polymers;
• stored in a container that is reliably sealed;
• certified by the laboratory or facility that preserved the animal or tissue as being treated to ensure complete preservation and fixation;
• no animal is, or will be, exposed directly or indirectly to the animal or tissue, or any of its derivatives; and
• the animal or tissue is not intended to be used for isolation or synthesis of viable microorganisms or infectious agents or their homologues.

The purpose of this amendment is to:

• recognise an additional treatment method (plastination) to manage biosecurity risk using curable polymers and the ability of laboratories and facilities to certify complete preservation and fixation
• remove references to the risk of plant or human exposure as the risk of importing animal or animal tissues relates to the exposure to animals only
• ensure imported preserved animals and animal tissues are not used for purposes including construction of viruses (using preserved DNA fragments) for genetic work.

Items 33, 34 and 37 remove references to section 54 from table 13 in section 38 of the Quarantine Proclamation to reflect that section 54 no longer exists.

Item 35 substitutes item 16 of table 13 in section 38 of the Quarantine Proclamation with a new item 16 to ensure that the reference to percentage by weight is consistent with table item 30 and removes reference to a section that no longer exists (section 54).

The effect of the amendment is to clarify that for processed elasmobranch fish products (e.g. fish fingers, fish cakes and fish balls, but excluding fish meal) that contains less than 10% by weight of egg or egg product and is fit for human consumption does not require an import permit to be imported into mainland Australia.

Item 36 substitutes item 20A of table 13, in section 38 of the Quarantine Proclamation with a new item 20A so that an import permit is not required for the importation of prawn-based food products, if shelf stable.

The purpose of the amendment is to expand the class of prawn-based food products that are able to be imported without an import permit. This will reflect the assessment that biosecurity risk of commercial consignments of prawn-based food products (if shelf stable) is managed effectively and the exemption from import permit requirements should not be limited to prawn-based food products (if shelf stable) for personal consumption.

Items 38, 39 and 40 remove references to section 53 from table 13 in section 38 of the Quarantine Proclamation to reflect that section 53 no longer exists.

Item 41 inserts new items 29D and 29E into table 13 in section 38 of the Quarantine Proclamation so that an import permit is not required for the importation of:

• commercially prepared soap, if the ingredients derived from biological materials have undergone a process of saponification; and
• unused blood collection tubes containing anticoagulant.

The purpose of the amendment is to reflect that the manufacturing processes used to create these products and the product end uses have acceptably low level of biosecurity risk and should not require an import permit in order to import them into mainland Australia.

Item 42 removes a hyphen from ‘shelf-stable’ in item 31 of table 13 in subsection 38 of the Quarantine Proclamation to correct a typographical error.

Item 43 substitutes ‘Pate’ for ‘Pâté’ in item 31B of table 13 in section 38 of the Quarantine Proclamation to correct a typographical error.

Items 44, 45, 46, 47 and 49 replace ‘DAFF FMD’ with ‘Department of Agriculture FMD-Free’ in sections 38 and 40 of the Quarantine Proclamation.

The purpose of the amendments is to update the Department of Agriculture FMD-Free list to reflect the current name of the Department consistent with the amendments that are made by items 4 and 5.

Item 48 substitutes ‘Department of Agriculture, Fisheries and Forestry’ with ‘Agriculture Department’s’ in subparagraph 40(2)(l)(iv) of the Quarantine Proclamation.

The purpose of the amendment is to reflect the current name of the Department.

Item 50 repeals clause 9 of Schedule 1 to the Quarantine Proclamation.

The purpose of the amendment is to remove reference to the Byford quarantine station in Western Australia from the list of quarantine stations for animals or goods in mainland Australia as it is no longer operational.

Items 51 and 53 insert 117 seed species into the ‘permitted seeds’ list in Schedule 5 to the Quarantine Proclamation.

The purpose of the amendment is to remove the requirement for importers to obtain an import permit for these seed species because they have been assessed by the Department as posing a level of risk that does not exceed Australia’s Appropriate Level of Protection (ALOP) in regards to their potential to introduce pests or diseases.

The effect of the amendment is that these seed species will be able to be imported into mainland Australia without an import permit. Removing the need to obtain an import permit for these seed species will enable their importation free of the administrative, regulatory or cost burden that may be associated with obtaining import permits.

Item 52 omits one seed species from Schedule 5 to the Quarantine Proclamation.

The purpose of the amendment is to remove one seed species (Daucus carota) which has been assessed by the Department as posing a level of risk that does not achieve Australia’s ALOP.

The effect of removal of this seed species is to prohibit importation of this species without an import permit. Importers will be required to apply for an import permit and this seed species will be subject to quarantine conditions determined by the Director of Quarantine to manage the risk associated with its import.

Schedule 2 – Quarantine (Christmas Island) Proclamation 2004

Items 1 and 3 repeal the definitions of ‘Christmas Island’, ‘Cocos Islands’, ‘Director of Quarantine’ and ‘Officer’ in section 3 of the Christmas Island Proclamation and insert a note to refer to these definitions in the Quarantine Act.

The purpose of the amendments is to remove definitions from the Christmas Island Proclamation which are set out in the Act and insert a note directing readers to the Act consistent with current drafting practice.

Item 2 inserts a definition of ‘biological material’ in section 3 of the Christmas Island Proclamation.

The purpose of the amendment is to clarify the use of the term ‘biological material’ in the Christmas Island Proclamation, which includes any material originating from an animal, plant or microbial source, as opposed to non-biological (semi-synthetic) material.

Item 4 inserts a definition of ‘veterinary therapeutic use’ in section 14 of the Christmas Island Proclamation.

The purpose of the amendment is to set out the meaning of the term that is inserted by item 7, and to distinguish between veterinary food and therapeutic products.

Veterinary therapeutic use products are subject to regulatory requirements imposed by the Australian Pesticides and Veterinary Medicines Authority in which the Department of Agriculture can be confident that the claims and associated risks have been assessed. Veterinary food products are not subject to these requirements.

Item 5 substitutes item 23 of table 5 in section 14 of the Christmas Island Proclamation with a new item 23.

The purpose of the amendment is to expand the list of microbial fermentation products that do not require an import permit for importation (lactic acid, citric acid, xanthum gum, purified vitamins or purified amino acids) as they are prolifically used in a range of commodities and have a low biosecurity risk because they have been highly purified.

The effect of the amendment is to better align regulatory control of the importation of these products with the associated biosecurity risk. Currently, the importation of microbial fermentation products (other than alcohols, vitamins and amino acids) is prohibited unless an import permit is granted. The amendment makes the description in item 23 more specific and expands the list of products that do not require an import permit to minimise regulatory burden on importers.

Item 6 inserts ‘or (3)’ after ‘subsection (2)’ in paragraphs 15(1)(a), (b) and (c) of the Christmas Island Proclamation.

Section 15 of the Christmas Island Proclamation provides that articles that are prohibited biological materials or contain prohibited biological material (set out in table 5), or articles of which prohibited biological material is an ingredient cannot be imported unless an import permit has been granted. However, the import of certain articles is permitted without an import permit under subsection 15(2) if they are for hospital use.

The purpose of the amendment is to insert a reference to subsection 15(3) (which is inserted in the Christmas Island Proclamation by item 7) so that the biological materials listed in these provisions may be imported without an import permit.

Item 7 adds subsection 15(3) and table 5A to the Christmas Island Proclamation.

The purpose of the amendment is to allow an article that:

• in normal use, is generally meant for human consumption, human therapeutic use or veterinary therapeutic use;
• is commercially prepared and packaged in a form that requires no further processing or repackaging before retail sale; and
• is a biological material listed in table 5A and are not otherwise prohibited

to be imported without the requirement for an import permit to reflect the very low biosecurity risk associated with those articles (such as alcohol swabs and fish oil tablets).

Item 8 substitutes subsection 16(2) of the Christmas Island Proclamation with a new subsection 16(2).

The purpose of the amendment is to allow substances or articles intended for human therapeutic use in a commercially prepared and packaged form (i.e. in a fully finished, retail ready form) to be imported without an import permit. This will recognise that there is no additional biosecurity risk associated with starter cultures intended for human therapeutic products as starter cultures intended for human food or beverages. Human therapeutic products are subject to specific regulatory controls concerning safety as administered by the Therapeutic Goods Administration.

Item 9 substitutes table 6 in section 16 of the Christmas Island Proclamation with a new table 6.

The purpose of the amendment is to update the list of substances or articles that are starter cultures or derivatives of starter cultures in table 6 that may be introduced or imported into Christmas Island without a permit. However, this is only possible if the substance or article is intended for the purposes set out in subsection 16(2) (e.g. human food or beverages or human therapeutic use).

The updated list of starter cultures was identified as a result of a review of permitted enzymes (and microbes that produce those enzymes) by Food Standards Australia New Zealand (FSANZ) against the Department’s current list of microbes for bioremediation use. The following additions to table 6 were identified where the two lists reference the same microorganism.

In practice, if FSANZ lists the microorganism then the Department may approve it for use and it should be appropriately identified as an approved starter culture for a specific end use in legislation.

The amendment also:

• removes existing table item 42 Streptococcus paracitrovirum, as this name is no longer referred to in laboratory use
• fixes a typographical error at existing table item 10 to read ‘Debaryomyces spp.’
• adds a synonym at existing table item 27 to read ‘Penicillium camemberti (also known as Penicillium camembertii)’
• adds a synonym at existing table item 28 to read ‘Penicillium roqueforti (also known as Penicillium roquefortii)’.

Item 10 substitutes the table and column headings of table 7 in section 17 of the Christmas Island Proclamation with new table and column headings to reflect current drafting practice.

Item 11 substitutes item 1 of table 7 in section 17 of the Christmas Island Proclamation with a new item 1.

The purpose of the amendment is to amend the list of articles likely to introduce a pest or disease so that soil, articles with soil adhering and articles that contain soil are articles likely to introduce a pest or disease unless they are treated by an approved treatment on arrival.

The effect of the amendment is to reflect current practice, which is to exclude articles or things containing untreated soil from entering Christmas Island and allow soil, articles with soil adhering and articles containing soil treated in an approved way to enter Christmas Island. The provision purposefully does not specify the treatment as it is expected that treatment methods will change over time. A standard list of treatments is maintained by the Department.

Item 12 substitutes item 1 of table 8, in section 24 of the Christmas Island Proclamation with a new item 1 to clarify the types of preserved animals and animal tissues (including fish) that do not require an import permit for importation into Christmas Island.

The new item allows preserved animals and animal tissues (including fish) to be imported into Christmas Island without an import permit if it is:

• preserved and fixed in 70% alcohol or 10% formalin or a minimum of 2% glutaraldehyde, or plastinated using curable polymers;
• stored in a container that is reliably sealed;
• certified by the laboratory or facility that preserved the animal or tissue as being treated to ensure complete preservation and fixation;
• no animal is, or will be, exposed directly or indirectly to the animal or tissue, or any of its derivatives; and
• the animal or tissue is not intended to be used for isolation or synthesis of viable microorganisms or infectious agents or their homologues.

The purpose of this amendment is to:

• recognise an additional treatment method (plastination) to manage biosecurity risk using curable polymers and the ability of laboratories and facilities to certify complete preservation and fixation
• remove references to the risk of plant or human exposure as the risk of importing animal or animal tissues relates to the exposure to animals only
• ensure imported preserved animals and animal tissues are not used for purposes including construction of viruses (using preserved DNA fragments) for genetic work.

Schedule 3 – Quarantine (Cocos Islands) Proclamation 2004

Items 1 and 3 repeal the definitions of ‘Christmas Island’, ‘Cocos Islands’, ‘Director of Quarantine’ and ‘Officer’ in section 3 of the Cocos Islands Proclamation and insert a note to refer to these definitions in the Quarantine Act.

The purpose of the amendments is to remove definitions from the Cocos Islands Proclamation which are set out in the Act and insert a note directing readers to the Act consistent with current drafting practice.

Item 2 inserts a definition of ‘biological material’ in section 3 of the Cocos Islands Proclamation.

The purpose of the amendment is to clarify the use of the term ‘biological material’ in the Cocos Islands Proclamation, which includes any material originating from an animal, plant or microbial source, as opposed to non-biological (semi-synthetic) material.

Item 4 inserts a definition of ‘veterinary therapeutic use’ in section 14 of the Cocos Islands Proclamation.

The purpose of the amendment is to set out the meaning of the term that is inserted by item 7, and to distinguish between veterinary food and therapeutic products.

Veterinary therapeutic use products are subject to regulatory requirements imposed by the Australian Pesticides and Veterinary Medicines Authority in which the Department of Agriculture can be confident that the claims and associated risks have been assessed. Veterinary food products are not subject to these requirements.

Item 5 substitutes item 23 of table 6 in section 14 of the Cocos Islands Proclamation with a new item 23.

The purpose of the amendment is to expand the list of microbial fermentation products that do not require an import permit for importation (lactic acid, citric acid, xanthum gum, purified vitamins or purified amino acids) as they are prolifically used in a range of commodities and have a low biosecurity risk because they have been highly purified.

The effect of the amendment is to better align regulatory control of the importation of these products with the associated biosecurity risk. Currently, the importation of microbial fermentation products (other than alcohols, vitamins and amino acids) is prohibited unless an import permit is granted. The amendment makes the description in item 23 more specific and expands the list of products that do not require an import permit to minimise regulatory burden on importers.

Item 6 inserts ‘or (3)’ after ‘subsection (2)’ in paragraphs 15(1)(a), (b) and (c) of the Cocos Islands Proclamation.

Section 15 of the Cocos Islands Proclamation provides that articles that are prohibited biological materials or contain prohibited biological material (set out in table 6), or articles of which prohibited biological material is an ingredient cannot be imported unless an import permit has been granted. However, the import of certain articles is permitted without an import permit under subsection 15(2) if they are for hospital use.

The purpose of the amendment is to insert a reference to subsection 15(3) (which is inserted in the Cocos Islands Proclamation by item 7) so that the biological materials listed in these provisions may be imported without an import permit.

Item 7 adds subsection 15(3) and table 6A to the Cocos Islands Proclamation.

The purpose of the amendment is to allow an article that:

• in normal use, is generally meant for human consumption, human therapeutic use or veterinary therapeutic use; and
• is commercially prepared and packaged in a form that requires no further processing or repackaging before retail sale; and
• is a biological material listed in table 6A and are not otherwise prohibited

to be imported without the requirement for an import permit to reflect the very low biosecurity risk associated with those articles (such as alcohol swabs and fish oil tablets).

Item 8 substitutes subsection 16(2) of the Cocos Islands Proclamation with a new subsection 16(2).

The purpose of the amendment is to allow substances or articles intended for human therapeutic use in a commercially prepared and packaged form (i.e. in a fully finished, retail ready form) to be imported without an import permit. This would recognise that there is no additional biosecurity risk associated with starter cultures intended for human therapeutic products as starter cultures intended for human food or beverages. Human therapeutic products are subject to specific regulatory controls concerning safety as administered by the Therapeutic Goods Administration.

Item 9 substitutes table 7 in section 16 of the Cocos Islands Proclamation with a new table 7.

The purpose of the amendment is to update the list of substances or articles that are starter cultures or derivatives of starter cultures in table 7 that may be introduced or imported into Cocos (Keeling) Islands without a permit. However, this will only be possible if the substance or article is not contained in a milk-based carrier and is intended for the purposes set out in subsection 16(2) (e.g. human food or beverages or human therapeutic use).

The updated list of starter cultures was identified as a result of a review of permitted enzymes (and microbes that produce those enzymes) by Food Standards Australia New Zealand (FSANZ) against the Department’s current list of microbes for bioremediation use. The following additions to table 7 were identified where the two lists reference the same microorganism.

In practice, if FSANZ lists the microorganism then the Department may approve it for use and it should be appropriately identified as an approved starter culture for a specific end use in legislation.

The amendment also:

• removes existing table item 42 Streptococcus paracitrovirum, as this name is no longer referred to in laboratory use
• fixes a typographical error at existing table item 10 to read ‘Debaryomyces spp.’
• adds a synonym at existing table item 27 to read ‘Penicillium camemberti (also known as Penicillium camembertii)’
• adds a synonym at existing table item 28 to read ‘Penicillium roqueforti (also known as Penicillium roquefortii)’.

Item 10 substitutes the table and column headings of table 8 in section 17 of the Cocos Islands Proclamation with new table and column headings to reflect current drafting practice.

Item 11 substitutes item 1 of table 8 in section 17 of the Cocos Islands Proclamation with a new item 1.

The purpose of the amendment is to amend the list of articles likely to introduce a pest or disease so that soil, articles with soil adhering and articles that contain soil are articles likely to introduce a pest or disease unless they are treated by an approved treatment on arrival.

The effect of the amendment is to reflect current practice, which is to exclude articles or things containing untreated soil from entering Cocos (Keeling) Islands and allow soil, articles with soil adhering and articles containing soil treated in an approved way to enter Cocos (Keeling) Islands. The provision purposefully does not specify the treatment as it is expected that treatment methods will change over time. A standard list of treatments is maintained by the Department.

Item 12 substitutes item 1 of table 9, in section 24 of the Cocos Islands Proclamation with a new item 1 to clarify the types of preserved animals and animal tissues (including fish) that do not require an import permit for importation into Cocos (Keeling) Islands.

The new item allows preserved animals and animal tissues (including fish) to be imported into the Cocos (Keeling) Islands without an import permit if it is:

• preserved and fixed in 70% alcohol or 10% formalin or a minimum of 2% glutaraldehyde, or plastinated using curable polymers; and
• stored in a container that is reliably sealed; and
• certified by the laboratory or facility that preserved the animal or tissue as being treated to ensure complete preservation and fixation; and
• no animal is, or will be, exposed directly or indirectly to the animal or tissue, or any of its derivatives; and
• the animal or tissue is not intended to be used for isolation or synthesis of viable microorganisms or infectious agents or their homologues.

The purpose of this amendment is to:

• recognise an additional treatment method (plastination) to manage biosecurity risk using curable polymers and the ability of laboratories and facilities to certify complete preservation and fixation
• remove references to the risk of plant or human exposure as the risk of importing animal or animal tissues relates to the exposure to animals only
• ensure imported preserved animals and animal tissues are not used for purposes including construction of viruses (using preserved DNA fragments) for genetic work.

ATTACHMENT

Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

Quarantine Legislation Amendment (2014 Measures No. 2) Proclamation 2014

This Legislative Instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.

Overview of the Legislative Instrument

The Legislative Instrument amends the Quarantine Proclamation 1998, the Quarantine (Christmas Island) Proclamation 2004 and the Quarantine (Cocos Islands) Proclamation 2004 to align regulatory controls for a range of imported biological goods with the level of biosecurity risk to increase the number of low biosecurity risk commodities that can be imported without a permit.

The Legislative Instrument amends Schedule 5 to the Quarantine Proclamation 1998 which lists all the seed species which may be imported into Australia without an import permit by inserting 117 seed species and omitting 1 seed species to reflect recent risk assessments undertaken by the Department.

The Legislative Instrument also removes reference to the now closed Byford quarantine station from the Quarantine Proclamation 1998.

Human rights implications

This Legislative Instrument does not engage any of the applicable rights or freedoms.

Conclusion

This Legislative Instrument is compatible with human rights as it does not raise any human rights issues.

The Hon. Barnaby Joyce MP

Minister for Agriculture