AGRICULTURAL AND VETERINARY CHEMICALS LEGISLATION AMENDMENT (OPERATIONAL EFFICIENCY) BILL 2017 Explanatory Memorandum

Commonwealth of Australia Explanatory Memoranda

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AGRICULTURAL AND VETERINARY CHEMICALS LEGISLATION AMENDMENT (OPERATIONAL EFFICIENCY) BILL 2017

2016-2017 THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA HOUSE OF REPRESENTATIVES AGRICULTURAL AND VETERINARY CHEMICALS LEGISLATION AMENDMENT (OPERATIONAL EFFICIENCY) BILL 2017 EXPLANATORY MEMORANDUM (Circulated by authority of the Deputy Prime Minister and Minister for Agriculture and Water Resources, the Hon. Barnaby Joyce MP)

AGRICULTURAL AND VETERINARY CHEMICALS LEGISLATION AMENDMENT (OPERATIONAL EFFICIENCY) BILL 2017 GENERAL OUTLINE The Agricultural and Veterinary Chemicals Legislation Amendment (Operational Efficiency) Bill 2017 (the Bill) will make minor and technical amendments to the Agricultural and Veterinary Chemicals (Administration) Act 1992 (the Administration Act), the Agricultural and Veterinary Chemicals Code Act 1994 (the Code Act) and the Agricultural and Veterinary Chemical Products (Collection of Levy) Act 1994 (the Levy Act), to realise operational efficiencies, reduce unnecessary regulation, clarify ambiguities and remove redundant provisions. Agricultural and veterinary (agvet) chemicals are regulated through a cooperative National Registration Scheme (NRS). The NRS is a partnership between the Commonwealth and the states and territories with an agreed division of responsibilities. Assessment and registration of agvet chemicals, as well as control of supply activities up to and including the point of retail sale, is undertaken by the Australian Pesticides and Veterinary Medicines Authority (the APVMA). The control of agvet chemical use after sale is the responsibility of individual states and territories. The Bill:  reduces the regulatory burden on industry by simplifying reporting requirements for annual returns;  reduces the administrative burden on the APVMA and industry by increasing the flexibility of the APVMA to manage errors in an application at the preliminary assessment stage;  reduces the regulatory burden by enabling the APVMA to grant part of a variation application under section 27 of the Schedule to the Code Act (the Agvet Code);  enables a person to apply to vary the relevant particulars or conditions of a label approval that is suspended, to the extent that the variation relates to the grounds for suspension;  establishes civil pecuniary penalties for contraventions of provisions relating to providing false or misleading information in the Agvet Code and the Administration Act;  amends the notification requirements in section 8E of the Agvet Code so that the APVMA and FSANZ will have the flexibility to agree on appropriate timeframes for notifications;  amends the definition of expiry date in the Agvet Code to mean the date after which a chemical product 'must not' be used; and  makes minor and technical amendments to the Administration Act and the Agvet Code, including the repeal of redundant provisions. An exposure draft of the Bill was released for public consultation in June 2017. Consultation also occurred with relevant state and territory authorities and appropriate Commonwealth agencies. The exposure draft of the Bill was amended following this consultation. FINANCIAL IMPACT STATEMENT The Bill will have no financial impact on the Australian Government Budget. 1

STATEMENT OF COMPATIBILITY WITH HUMAN RIGHTS This Bill 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. The full statement of compatibility with human rights is attached to this explanatory memorandum. 2

ACRONYMS, ABBREVIATIONS AND COMMONLY USED TERMS Administration Act Agricultural and Veterinary Chemicals (Administration) Act 1992 Administration Regulations Agricultural and Veterinary Chemicals (Administration) Regulations 1995 Agvet agricultural and veterinary Agvet Code the Agricultural and Veterinary Chemicals Code, as set out in the Schedule to the Agricultural and Veterinary Chemicals Code Act 1994 Agvet Code Regulations Agricultural and Veterinary Chemicals Code Regulations 1995 APVMA Australian Pesticides and Veterinary Medicines Authority Code Act Agricultural and Veterinary Chemicals Code Act 1994 Constitution Commonwealth of Australia Constitution Act Crimes Act Crimes Act 1914 Criminal Code Criminal Code Act 1995 the Department the Department administered by the Minister administering the Agricultural and Veterinary Chemicals (Administration) Act 1992 FSANZ Food Standards Australia New Zealand Guide to Framing the Guide to Framing Commonwealth Offences, Commonwealth Offences Infringement Notices and Enforcement Powers published by the Attorney-General's Department interested person defined by subsection 3(1) of the Agricultural and Veterinary Chemical Products (Collection of Levy) Act 1994 to mean, in relation to a registered chemical product: (a) subject to paragraphs (b), (c) and (d), the person (the original applicant) who applied for the registration or, in the case of a chemical product whose registration has been renewed, applied for the renewal, or the last renewal, as the case may be, of the registration; or (b) subject to paragraphs (c) and (d), if the original applicant has entered into a contract with another person in relation to the chemical product under which, or as a result of which, the other person will 3

or may apply to the APVMA to have the other person's name entered in the relevant particulars in relation to the chemical product, or to have a label approved in relation to containers for the chemical product, and the other person's name is entered in those relevant particulars, or such a label is approved, on the application of the other person-- the other person; or (c) if the person who, apart from this paragraph, would be the interested person because of paragraph (a) or (b), was an individual who has died or is an individual whose affairs are being lawfully administered by another person--the legal representative of the individual or the person administering his or her affairs, as the case may be; or (d) if the person who, apart from this paragraph, would be the interested person because of paragraph (a) or (b), was a body corporate--a successor in law of that body corporate. leviable disposal defined by subsection 3(1) of the Agricultural and Veterinary Chemical Products (Collection of Levy) Act 1994 to mean: (a) if the product is an Australian product: (i) if the product is disposed of in Australia by the manufacturer--that disposal of the product; or (ii) if the product is applied by the manufacturer to the manufacturer's own use--that application of the product; or (b) if the product is an imported product: (i) if the product is disposed of in Australia by the importer--that disposal of the product; or (ii) if the product is applied by the importer to the importer's own use--that application of the product. Levy Act Agricultural and Veterinary Chemical Products (Collection of Levy) Act 1994 the Minister the Minister administering the Agricultural and Veterinary Chemicals (Administration) Act 1992 NRS National Registration Scheme Privacy Act Privacy Act 1988 the Secretary the Secretary of the Department administered by the Minister administering the Agricultural and Veterinary Chemicals (Administration) Act 1992 4

Therapeutic Goods Act Therapeutic Goods Act 1989 TRIPS Agreement Agreement on Trade-Related Aspects of Intellectual Property Rights 5

NOTES ON CLAUSES Preliminary Clause 1 Short Title Clause 1 provides for the short title of the Act to be the Agricultural and Veterinary Chemicals Legislation Amendment (Operational Efficiency) Act 2017. Clause 2 Commencement Clause 2 provides for the commencement of each provision in the Bill, as set out in the table. Subclause 2(1) provides that each provision of the Bill specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms. Item 1 in the table provides that sections 1, 2 and 3, which concern the formal aspects of the Bill, as well as anything in the Bill not elsewhere covered by the table, will commence on the day on which the Bill receives the Royal Assent. Item 2 in the table provides that Part 1 of Schedule 1 to the Bill will commence on the day after the Bill receives the Royal Assent. Item 3 in the table provides that Part 2 of Schedule 1 to the Bill will commence on the day after the end of the period of 12 months beginning on the day the Bill receives the Royal Assent. Deferring commencement for 12 months for Part 2 of Schedule 1 to the Bill is necessary to ensure the APVMA can implement a staged introduction of measures in the Bill, with the measures in Part 2 to be implemented after other measures in the Bill have been implemented. Item 4 in the table provides that Parts 3, 4 and 5 of Schedule 1 to the Bill will commence on the day after the end of the period of three months beginning on the day the Bill receives the Royal Assent. Deferring commencement for three months for Parts 3, 4 and 5 of Schedule 1 to the Bill is necessary to ensure the APVMA can implement a staged introduction of these measures after the measures in Parts 6, 7 and 8 of the Bill have been implemented. This deferral will also allow sufficient time to appropriately implement necessary changes to policies, procedures and training protocols as a result of the amendments. Item 5 in the table provides that Parts 6, 7 and 8 of Schedule 1 to the Bill will commence on the day after the Bill receives the Royal Assent. Subclause 2(2) provides that any information in column 3 of the table is not part of the Bill. Information may be inserted in column 3 of the table, or information in it may be edited, in any published version of the Bill. Clause 3 Schedules Clause 3 provides that legislation that is specified in a Schedule to the Bill is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to the Bill has effect according to its terms. 6

Schedule 1--Amendments PART 1--ANNUAL RETURNS AND RECORD-KEEPING Overview Part 1 of Schedule 1 to the Bill seeks to amend the Levy Act and the Administration Act to simplify reporting requirements for annual returns, restricting mandatory reporting to total chemical product quantities supplied for the previous financial year. The proposed amendments seek to reduce the regulatory burden on industry for reporting requirements, while ensuring sufficient data is provided to the Australian Government to assist with policy development and international reporting requirements. Agricultural and Veterinary Chemical Products (Collection of Levy) Act 1994 Item 1 Subsection 3(1) Item 1 amends subsection 3(1) of the Levy Act to insert a definition of active constituent to provide that the term has the same meaning as it does in the Agvet Code. The insertion of a definition of active constituent in subsection 3(1) of the Levy Act is necessary to complement the insertion of a new section 35 of the Levy Act by item 2 below. Item 2 After section 34 Item 2 inserts a new section 35 after section 34 of the Levy Act. The new section 35 of the Levy Act requires interested persons (defined by subsection 3(1) of the Levy Act) to provide annual returns to the APVMA about the total quantity of chemical products covered by leviable disposals during a financial year. The term leviable disposal, in relation to a chemical product, is defined by subsection 3(1) of the Levy Act. The new section 35 of the Levy Act will provide for a more simplified annual return reporting system than current section 69E of the Administration Act, which is repealed by item 5 below. New section 35 establishes an annual return reporting system based on the leviable disposals of chemical products. Section 69E of the Administration Act currently provides for annual returns that must be given to the APVMA by persons who import, manufacture, or export active constituents for proposed or existing chemical products or in chemical products. New subsection 35(1) of the Levy Act provides that an interested person in relation to a chemical product who is liable to pay levy in respect of leviable disposals of that product that took place anywhere in Australia at any time during a financial year, must give to the APVMA, before 30 November in the next financial year, a return setting out the total quantity of the chemical product covered by those leviable disposals. Reporting on chemical product quantities will provide the APVMA with information necessary for the performance of its functions and powers, and is much less complex and burdensome for industry than the current annual returns required under section 69E of the Administration Act. The new simplified reporting requirements will also reduce the returns to one single element instead of the possible six annual return elements that are currently required. New subsection 35(1) of the Levy Act will align the annual reporting of quantities of active constituents with existing reporting on the financial value of leviable disposals of chemical products. 7

New subsection 35(1) of the Levy Act ensures that the APVMA can continue to collect information about agvet chemicals in the marketplace. This information is used by the Australian Government for policy development and to meet international reporting requirements under international conventions and international arrangements. For example, the data collected will provide the government with information as to the amount of active constituent that is supplied in Australia, and will allow the government to determine the effect of any restrictions or conditions that other countries may propose on agvet chemicals. Status of provided information New subsection 35(1) will require the interested person to provide the quantity of chemical products disposed of during a financial year, in addition to the financial value of this quantity of chemical products. The new requirement to provide the APVMA with information on the quantity of chemical products may mean that interested persons need to provide personal information to the APVMA. However, this information will be no different to that already collected for the leviable disposal financial value. For this reason, the new annual return reporting requirement will not result in the collection of any new personal information. The APVMA will manage this information in the same manner as it manages personal information now. Information on the quantity of chemical products disposed during a financial year may be commercially sensitive information. The APVMA would manage this information in the same manner as it manages the financial value of disposals during a financial year, which is of an equivalent commercial sensitivity. From the information provided to it by interested persons, the APVMA will use the information it holds about concentrations of active constituents in chemical products to prepare a statement for the Department setting out the quantities of each active constituent disposed of during the financial year. This statement will not include personal information. Exemptions in regulations The new subsection 35(2) of the Levy Act enables regulations made under that Act to exempt certain quantities of chemical products or certain chemical products from the obligation in new subsection 35(1) of that Act. It is necessary to include new subsection 35(2) of the Levy Act because it will allow the regulations to prescribe low quantities of chemical products for which an interested person is exempt from the requirement to provide an annual return. It will also allow the regulations to prescribe a limited range of 'low regulatory concern' chemical products that could be exempted from the annual return reporting requirements. Information about disposals of low quantities of chemical products or chemical products of low regulatory concern is of limited value to government and therefore it may be unnecessary to require annual returns in these instances. Strict liability offence The new subsection 35(3) of the Levy Act provides that a person commits an offence of strict liability, which is subject to a criminal pecuniary penalty of 50 penalty units, if that person contravenes the new subsection 35(1) of the Levy Act. See 'Items 2 and 3 - general matters' below for more information on this strict liability offence. 8

Civil penalty provision The new subsection 35(4) of the Levy Act provides that new subsection 35(1) of the Levy Act is also a civil penalty provision. See 'Items 2 and 3 - general matters' below for more information on this civil penalty provision. Notes at the end of the new subsection 35(4) of the Levy Act. Item 2 also inserts notes at the end of the new subsection 35(4) of the Levy Act. See 'Items 2 and 3 - general matters' below for more information on these notes. APVMA statement about annual returns New subsection 35(5) of the Levy Act provides that, from the returns given to the APVMA in relation to a financial year, the APVMA must give the Secretary, before the end of the next financial year, a statement or statements setting out the total quantities of each active constituent for each chemical product covered by those returns. This new subsection preserves the effect of current subsection 69E(3) of the Administration Act, which is repealed by item 5 below. New subsection 35(5) of the Levy Act is necessary to ensure that the Department receives information from the APVMA that relates to total quantities of active constituents for chemical products covered by leviable disposals in a timely manner. This information assists the Department with ongoing policy development and enables it to meet international reporting requirements under international conventions and international arrangements. Severability provisions New subsection 35(6) of the Levy Act is a severability provision and is needed to provide the alternative constitutional bases that the section relies upon. This will allow the section to operate on the basis of these alternative constitutional bases and avoid ambiguities in interpreting the constitutional basis for new section 35, if it is held that there may be an insufficient constitutional basis for the section. New subsection 35(7) of the Levy Act states that a term used in new subsection 35(6) of that Act and the Constitution has the same meaning in new subsection 35(6) of the Levy Act as it has in the Constitution. New subsection 35(7) of the Levy Act is necessary to complement new subsection 35(6) of the Levy Act. Item 3 After section 36 Item 3 inserts new section 37 after section 36 of the Levy Act. New section 37 of the Levy Act creates record-keeping requirements for those interested persons (as defined by subsection 3(1) of the Levy Act) to which new section 35 of the Levy Act will apply. New section 35 of the Levy Act is inserted by item 2 above. The obligation to keep and retain records in new subsection 37(1) of the Levy Act applies to an interested person. New section 37 of the Levy Act is necessary to complement new section 35 of the Levy Act (which is inserted by item 2 above), and broadly preserves the effect of current subsection 69EA(1) of the Administration Act, which is amended by items 6 and 7 below. It is appropriate that the obligation on interested persons to keep records in relation to leviable disposals of chemical products is inserted into the Levy Act, and repealed from the 9

Administration Act. This is because it will place interested persons on notice to guard against the possibility of any contravention of the Levy Act by keeping the relevant records for the specified period of time so the APVMA can, if necessary, verify information in annual returns provided under new subsection 35(1) of the Levy Act. Strict liability offence The new subsection 37(2) of the Levy Act provides that a person commits an offence of strict liability, which is subject to a criminal pecuniary penalty of 50 penalty units, if that person contravenes the new subsection 37(1) of the Levy Act. See 'Items 2 and 3 - general matters' below for more information on this strict liability offence. Civil penalty provision The new subsection 37(3) of the Levy Act provides that new subsection 37(1) of the Levy Act is also a civil penalty provision. See 'Items 2 and 3 - general matters' below for more information on this civil penalty provision. Notes at the end of the new subsection 37(3) of the Levy Act. Item 3 also inserts notes at the end of the new subsection 37(3) of the Levy Act. See 'Items 2 and 3 - general matters' below for more information on these notes. Severability provisions New subsection 37(4) of the Levy Act is a severability provision and is needed to provide the alternative constitutional bases that the section relies upon. This will allow the section to operate on the basis of these alternative constitutional bases and avoid ambiguities in interpreting the constitutional basis for new section 37, if it is held that there may be an insufficient constitutional basis for the section. New subsection 37(5) of the Levy Act states that a term used in new subsection 37(4) of that Act and the Constitution has the same meaning in new subsection 37(4) of the Levy Act as it has in the Constitution. New subsection 37(5) of the Levy Act is necessary to complement new subsection 37(4) of the Levy Act. Items 2 and 3 - general matters Item 2 inserts a new section 35 after section 34 of the Levy Act. The new section 35 of the Levy Act requires interested persons (as defined by subsection 3(1) of the Levy Act) to provide annual returns to the APVMA about the total quantity of chemical products covered by leviable disposals during a financial year. Item 3 inserts new section 37 after section 36 of the Levy Act. New section 37 of the Levy Act creates record-keeping requirements for those interested persons to which new section 35 of the Levy Act will apply. These amending items have similar issues in relation to strict liability offences, civil penalty provisions and the notes that are inserted. For this reason, these general matters for both new sections have been combined and are described below. 10

Strict liability offence The new subsections 35(3) and 37(2) of the Levy Act provide that a person commits an offence of strict liability, which is subject to a criminal pecuniary penalty of 50 penalty units, if that person contravenes, respectively, the new subsection 35(1) or subsection 37(1) of the Levy Act. It is important to note that the applicable pecuniary penalty of 50 penalty units in new subsections 35(3) and 37(2) of the Levy Act is the maximum criminal pecuniary penalty that a relevant court could impose on an individual. The maximum criminal pecuniary penalty that a relevant court could impose on a body corporate for a contravention of new subsections 35(1) or 37(1) of the Levy Act will be 250 penalty units, due to the application of subsection 4B(3) of the Crimes Act to new subsections 35(3) and 37(2) of the Levy Act. Subsection 4B(3) of the Crimes Act states that, where a body corporate is convicted of an offence against a law of the Commonwealth, a court may, if the contrary intention does not appear and the court thinks fit, impose a pecuniary penalty not exceeding an amount equal to five times the amount of the maximum pecuniary penalty that could be imposed by the court on a natural personal convicted of the same offence. It is necessary to prescribe the conduct in new subsections 35(1) and 37(1) of the Levy Act as an offence of strict liability. This is because it will place interested persons on notice to guard against the possibility of any contravention of the Levy Act by providing their annual returns about chemical products at the required time and to keep the relevant records for the specified time period so the information in annual returns can be verified. Further, the proposed penalties in new subsections 35(3) and 37(2) are consistent with the penalty in current section 36 of the Levy Act and the current penalties in sections 69E and 69EA of the Administration Act. The application of strict liability in new subsections 35(3) and 37(2) of the Levy Act is appropriate because:  a contravention of new subsections 35(1) and 37(1) of the Levy Act is not punishable by imprisonment;  the applicable penalty for the strict liability offence is 50 penalty units for an individual and 250 penalty units for a body corporate (consistent with subsection 4B(3) of the Crimes Act, where no contrary intention exists); and  the punishment of the strict liability offence prescribed by new subsections 35(3) and 37(2) of the Levy Act is likely to significantly enhance the effectiveness of the enforcement regime of the Levy Act in deterring interested persons from either not providing annual returns to the APVMA or not keeping records for the specified period of time. Civil penalty provision The new subsections 35(4) and 37(3) of the Levy Act provide that, respectively, new subsections 35(1) and 37(1) of the Levy Act are also civil penalty provisions. Items 2 and 3 also insert notes at the end of the new subsections 35(4) and 37(3) of the Levy Act. Note 2 to new subsections 35(4) and 37(3) of the Levy Act direct the reader to Division 1 of Part 7AB of the Administration Act, which creates a framework for the use of civil penalties to enforce the civil penalty provisions of the Administration Act and the 11

Levy Act (see the definition of civil penalty provision in section 4 of the Administration Act). Note 2 to new subsections 35(4) and 37(3) of the Levy Act is merely included to assist the reader. Subsection 69EJA(1) of the Administration Act provides that the pecuniary penalty for a contravention of a civil penalty provision by a body corporate must not exceed five times the amount of the maximum monetary penalty that could be imposed by a court if the body corporate were convicted of an offence constituted by conduct that is the same as the conduct constituting the contravention. Subsection 69EJA(2) of the Administration Act provides that the pecuniary penalty for a contravention of a civil penalty provision by an individual must not exceed three times the amount of the maximum monetary penalty that could be imposed by a court if the person were convicted of an offence constituted by conduct that is the same as the conduct constituting the contravention. By virtue of section 69EJA of the Administration Act, and the matters prescribed by new subsections 35(3) and 37(2) of the Levy Act (including the application of subsection 4B(3) of the Crimes Act to the new subsections), the civil pecuniary penalty for a contravention of new subsections 35(1) and 37(1) of the Levy Act will be 150 penalty units for individuals and 1250 penalty units for bodies corporate. New subsections 35(4) and 37(3) of the Levy Act are necessary to achieve the legitimate objective of placing interested persons on notice to guard against the possibility of any contravention of the Levy Act by providing their annual returns about chemical products at the required time and keeping relevant records for specified period of time. Subjecting the conduct in new subsections 35(1) and 37(1) of the Levy Act to a civil pecuniary penalty of 150 penalty units for individuals and 1250 penalty units for bodies corporate provides a necessary and proportionate deterrent to non-compliance with the obligation in those new subsections. Further, the proposed penalties are consistent with the penalty in current section 36 of the Levy Act and current sections 69E and 69EA of the Administration Act. Civil penalty provisions have been introduced as one component of differentiated enforcement provisions, which give greater flexibility and more opportunity to encourage non-compliant persons to become compliant. Notes at the end of the new subsections 35(4) and 37(3) of the Levy Act. Items 2 and 3 also insert notes at the end of the new subsections 35(4) and 37(3) of the Levy Act. Note 1 to the new subsections 35(4) and 37(3) of the Levy Act directs the reader to Part 7AA of the Administration Act, which provides for the monitoring and investigation powers of inspectors (as defined by section 4 of the Administration Act). This will apply to the Levy Act due to subsection 69EAB(1), sections 69EAH and 69EB and the definition of evidential material in section 4 of the Administration Act. It is appropriate that the powers and functions in Part 7AA of the Administration Act apply to the new sections 35 and 37 of the Levy Act, as that Part currently applies those powers and functions to other civil penalty provisions of the Levy Act. Note 1 to new subsections 35(4) and 37(3) of the Levy Act is merely included to assist the reader. Note 2 to new subsections 35(4) and 37(3) of the Levy Act directs the reader to Division 1 of Part 7AB of the Administration Act, which creates a framework for the use of civil penalties 12

to enforce the civil penalty provisions of the Administration Act and the Levy Act (see the definition of civil penalty provision in section 4 of the Administration Act). Note 2 to new subsections 35(4) and 37(3) of the Levy Act is merely included to assist the reader. Note 3 to new subsections 35(4) and 37(3) of the Levy Act directs the reader to Divisions 2, 3 and 6 of Part 7AB of the Administration Act, which provide for matters in relation to infringement notices, enforceable undertakings and formal warnings that may be used in relation to a contravention of new subsections 35(1) and 37(1) of the Levy Act. Divisions 3 and 6 of Part 7AB of the Administration Act will apply to new subsections 35(1) and 37(1) of the Levy Act due to subsections 69EL(1) and 69EO(1) of the Administration Act. It is appropriate that the powers and functions in Divisions 3 and 6 of Part 7AB of the Administration Act apply to new sections 35 and 37 of the Levy Act as those Divisions currently apply those powers and functions to other civil penalty provisions of the Levy Act. The references to Divisions 3 and 6 of Part 7AB of the Administration Act in note 3 to new subsections 35(4) and 37(3) of the Levy Act is merely included to assist the reader. Division 2 of Part 7AB of the Administration Act relates to the giving of infringement notices where an inspector (as defined by section 4 of the Administration Act) has reasonable grounds to believe that a person has contravened a prescribed civil penalty provision. Section 4 of the Administration Act defines prescribed civil penalty provision to mean a civil penalty provision that is prescribed by the Administration Regulations. Section 3A.01 of the Administration Regulations states that, for the definition of prescribed civil penalty provision in section 4 of the Administration Act, each civil penalty provision mentioned in Schedule 5 to the Administration Regulations is prescribed. New sections 35 and 37 of the Levy Act are not mentioned in Schedule 5 to the Administration Regulations. Division 2 of Part 7AB of the Administration Act will not apply to new sections 35 and 37 of the Levy Act unless Schedule 5 to the Administration Regulations is amended to list new sections 35 and 37 of the Levy Act. It is intended that Schedule 5 to the Administration Regulations will be amended at a later date to list new sections 35 and 37 of the Levy Act. The reference to Division 2 of Part 7AB of the Administration Act in note 3 to new subsections 35(4) and 37(3) of the Levy Act, is merely included to assist the reader. Item 4 Application provisions Sub-item 4(1) provides that new section 35 of the Levy Act, as inserted by item 2 above, applies in relation to leviable disposals that take place in the 2017-18 financial year or in a later financial year. The application of the new annual return reporting requirements in section 35 of the Levy Act from the 2017-18 financial year is appropriate. This is because the reporting period for the 2016-17 financial year has already passed and because it provides the APVMA and industry with time to prepare for the new reporting requirements for the 2017-18 financial year (due by 30 November 2018). This will allow time for the APVMA to notify interested persons of the new requirements and their obligation to provide the new simplified annual returns by 30 November 2018. Sub-item 4(2) provides that new section 37 of the Levy Act, as inserted by item 3 above, applies in relation to leviable disposals that take place on or after the commencement of Part 1 of Schedule 1 to the Bill. Part 1 of Schedule 1 to the Bill commences on the day after the Bill receives the Royal Assent. This will ensure that there is no retrospective application 13

of the requirement to keep records required by section 37. The records that are required to be kept for new section 37 will be similar to those currently required to be kept for section 69E of the Administration Act and the Bill allows the current form of records to be kept until the new record keeping requirements apply. Agricultural and Veterinary Chemicals (Administration) Act 1992 Item 5 Section 69E Item 5 repeals section 69E of the Administration Act, which currently provides for matters in relation to annual returns required from persons who import into, manufacture in, or export active constituents for proposed existing chemical products or existing chemical products from Australia. It is not necessary to retain section 69E of the Administration Act because new section 35 of the Levy Act will provide for a new simplified annual return reporting system. It is appropriate that the obligation on interested persons to provide annual returns in relation to leviable disposals of chemical products is inserted into the Levy Act and repealed from the Administration Act, because this will give effect to the new simplified annual return reporting system. The repeal of section 69E of the Administration Act is therefore consequential to the insertion of new section 35 of the Levy Act by item 2 above. Item 6 Subsection 69EA(1) (heading) Item 6 repeals the current subheading "Records relating to compliance with sections 69B, 69C and 69E" to subsection 69EA(1) of the Administration Act, and inserts the new subheading "Records relating to compliance with sections 69B and 69C" to that subsection. Item 6 is consequential to the amendments made by item 5 above, which repeals section 69E of the Administration Act and merely removes the redundant reference to section 69E. Item 7 Paragraph 69EA(1)(a) Item 7 omits the reference to "69B, 69C and 69E" in paragraph 69EA(1)(a) of the Administration Act and substitutes that reference with a reference to "69B and 69C". Item 7 is consequential to the amendments made by item 5 above, which repeals section 69E of the Administration Act and merely removes the redundant reference to section 69E. Item 8 Saving provisions Sub-items 8(1) and 8(2) provide that, despite the repeal of section 69E and amendment to section 69EA of the Administration Act by items 5, 6 and 7 above, those sections, as in force immediately before the commencement of Part 1 of Schedule 1 to the Bill, continue to apply on and after that commencement. Item 8 preserves the effect of section 69E and subsection 69EA(1) of the Administration Act, for the purposes of active constituents and chemical products that were imported, manufactured or exported before or during the 2016-17 financial year. Item 8 ensures that the requirements in new sections 35 and 37 of the Levy Act will not apply in relation to leviable disposals until the commencement of Part 1 of Schedule 1 to the Bill. Part 1 of Schedule 1 to the Bill commences on the day after the Bill receives the Royal Assent. 14

PART 2--PRELIMINARY ASSESSMENTS Overview Part 2 of Schedule 1 to the Bill seeks to amend the Agvet Code to provide the APVMA with greater flexibility to manage application errors during the preliminary assessment of those applications, which relate to:  approval or registration (see sections 10 and 11 of the Agvet Code); or  variation of approval or registration (see sections 27 and 28 of the Agvet Code). Currently, the APVMA must refuse an application if it does not meet the application requirements, including where that is the result of minor errors. The applicant must then make a new application, which is administratively burdensome for industry and time consuming for the APVMA. The proposed amendments will enable the APVMA to, following preliminary assessment of an application, notify an applicant of minor errors in their application, and provide them with one opportunity to address those errors or submit missing information, where this can be reasonably rectified. This flexibility is also consistent with the flexibility currently available for the preliminary assessment of permit applications under section 110A of the Agvet Code. Providing applicants with an opportunity to address errors or submit missing information will, for example, overcome situations where the applicant simply failed to attach the information, or attached the wrong piece of information, to the application. The amendments proposed by Part 2 of Schedule 1 to the Bill are not intended to provide applicants with the ability to rectify major errors in their applications or to provide more than one opportunity to rectify the defects. Agricultural and Veterinary Chemicals Code Act 1994 Item 9 Subsection 11(2) of the Code set out in the Schedule Item 9 omits the reference to "from the preliminary assessment" in subsection 11(2) of the Agvet Code, and substitutes that reference with "to the APVMA, after completing a preliminary assessment of the application or after defects in the application have been rectified in response to a notice under subsection (3),". Subsection 11(2) of the Agvet Code currently specifies notices that must be provided to the applicant and publication requirements for applications that meet the application requirements. Item 9 clarifies that the notice and publication requirements in subsection 11(2) of the Agvet Code apply to applications that meet the application requirements and applications that had minor defects and that have since been rectified. Item 9 is consequential to the amendments made by item 10 below. Item 10 Subsection 11(3) of the Code set out in the Schedule Item 10 repeals subsection 11(3) of the Agvet Code and substitutes new subsections 11(3) and (3A) of the Agvet Code. Subsection 11(3) of the Agvet Code currently provides that if subsection 11(2) of the Agvet Code does not apply to the application, the APVMA must refuse the application. New 15

subsections 11(3) and (3A) of the Agvet Code seek to provide an applicant with one opportunity to rectify minor defects in their application. Providing an applicant with one opportunity to rectify minor defects in an application will ensure both the APVMA and the applicant are provided with more flexibility during the assessment of an application. New subsection 11(3A) of the Agvet Code is necessary to preserve the integrity of the application process and provides that the APVMA must refuse the application if: (a) the APVMA is not satisfied that defects in the application can reasonably be rectified; or (b) the defects are not rectified to the satisfaction of the APVMA within the period mentioned in new paragraph 11(3)(c) of the Agvet Code. Item 10 also inserts a note at the end of new subsection 11(3A) of the Agvet Code to direct the reader to section 8G of the Agvet Code, which outlines the process the APVMA must follow when notifying an applicant of an application refusal. Item 11 Subsection 28(2) of the Code set out in the Schedule Item 11 will make the same changes to subsection 28(2) as are made to subsection 11(2) by item 9 above. This will mean the same preliminary assessment process will apply for applications to vary relevant particulars or conditions as applies for applications for approval or registration. Item 11 is consequential to the amendments made by item 12 below. Item 12 Subsection 28(3) of the Code set out in the Schedule Item 12 will make the same amendments to subsection 28(3) as are made to subsection 11(3) by item 10 above. This will mean the same preliminary assessment process will apply for applications to vary relevant particulars or conditions as applies for applications for approval or registration. Consistent with the amendments made to subsection 11(3), the amendments to subsection 28(3) will provide an applicant with an opportunity to rectify minor defects in their application. This will ensure both the APVMA and the applicant are provided with more flexibility during the assessment of an application, while preserving the integrity of the application process. As with item 10 above, item 12 also inserts a note at the end of new subsection 28(3A) of the Agvet Code to direct the reader to section 8G of the Agvet Code, which outlines the process the APVMA must follow when notifying an applicant of an application refusal. Item 13 Subsection 110A(2) of the Code set out in the Schedule Item 13 omits the reference to "from the preliminary assessment" in subsection 110A(2) of the Agvet Code, and substitutes that reference with a reference to "to the APVMA, after completing a preliminary assessment of the application or after defects in the application have been rectified in response to a notice under subsection (3),". Section 110A of the Agvet Code currently provides the APVMA with the ability to notify an applicant that they have an opportunity to rectify minor defects in an application (see subsections 110A(3) and (4) of the Agvet Code). Item 13 clarifies that the notice requirements in subsection 110A(2) of the Agvet Code apply to applications that meet the application requirements and applications that had minor defects that have since been 16

rectified. These amendments will mean that the same preliminary assessment process will apply for permit applications as applies for applications for approval or registration. Item 14 Subsection 110A(3) of the Code set out in the Schedule Item 14 omits the reference to "from the preliminary assessment" in subsection 110A(3) of the Agvet Code, and substitutes that reference with a reference to "to the APVMA, after completing a preliminary assessment of the application". Item 14 ensures that new subsections 11(3) and 28(3) of the Agvet Code and amended subsection 110A(3) of the Agvet Code are worded consistently to avoid ambiguity and provide that the same preliminary assessment process will apply for permit applications as applies for applications for approval or registration. Item 15 Application provision Item 15 provides that the proposed amendments in Part 2 of Schedule 1 to the Bill will apply in relation to applications lodged under sections 10, 27 or 110 of the Agvet Code on or after the commencement of Part 2 of Schedule 1 to the Bill. Item 15 ensures that the amendments proposed by Part 2 of Schedule 1 to the Bill will not apply retrospectively. Part 2 of Schedule 1 to the Bill will commence on the day after the end of the period of 12 months beginning on the day the Bill receives the Royal Assent. Deferring commencement for 12 months for Part 2 of Schedule 1 to the Bill is necessary to ensure the APVMA can implement a staged introduction of measures in the Bill, with the measures in Part 2 to be implemented after other measures in the Bill have been implemented. Extending the ability to rectify defects in approval and registration applications will take the APVMA more time to implement as:  there are more kinds of applications for registration and approval than for permits;  applications for registration and approval are more complex and have different data requirements than for permit applications (for which defects at preliminary assessment can already be rectified). 17

PART 3--VARIATION OF RELEVANT PARTICULARS AND CONDITIONS Overview Part 3 of Schedule 1 to the Bill seeks to amend the Agvet Code to enable the APVMA to vary the relevant particulars or conditions of an approval of an active constituent, a registration of a chemical product, or an approval of a label for containers for a chemical product in a way other than as set out in the original application for variation. This may include granting part of a variation application. Currently, under section 27 of the Agvet Code, a holder (which is defined by section 3 of the Agvet Code) may apply to the APVMA for variation of the relevant particulars or conditions of the approval of an active constituent, registration of a chemical product, or approval of a label for containers for a chemical product. The APVMA must vary the relevant particulars or conditions if it is satisfied that the application meets certain application requirements, and that the variation would meet applicable statutory criteria and established standards (see section 29 of the Agvet Code). However, the APVMA does not currently have the power to vary relevant particulars or conditions in a way other than as set out in the original application for variation, including the ability to grant part of such an application. As a result, the APVMA must grant or refuse an entire application based on its satisfaction of the matters set out in subsection 29(1) of the Agvet Code. In practice, the APVMA currently assists applicants to ensure that proposed variations are appropriately constructed in an application for variation in such a manner that would satisfy the APVMA of the matters set out in subsection 29(1) of the Agvet Code. For example, the application for variation may relate to chemical products for the purposes of wheat, barley and rice, but the information provided may only support satisfaction by the APVMA of the proposed variations in relation to wheat and barley. In such an example, the APVMA would work with the applicant to amend the application so that it relates only to wheat and barley. The proposed amendments seek to provide the APVMA with the flexibility to vary relevant particulars or conditions in a way other than as set out in the original application for variation, including providing an applicant with the opportunity to provide written submissions on such a variation. Agricultural and Veterinary Chemicals Code Act 1994 Item 16 At the end of subsection 8S(1) of the Code set out in the Schedule (before the note) Item 16 amends subsection 8S(1) of the Agvet Code to insert new paragraph 8S(1)(c) of the Agvet Code. The note to subsection 8S(1) of the Agvet Code currently directs the reader to Division 4 of Part 2 of the Agvet Code for notices in relation to reconsiderations. New paragraph 8S(1)(c) of the Agvet Code provides that the APVMA must give an applicant written notice of what it proposes to do before it varies, under section 29 of the Agvet Code, relevant particulars or conditions in a way other than set out in the original application. New paragraph 8S(1)(c) of the Agvet Code ensures an applicant has the opportunity to provide written submissions to the APVMA in relation to a proposed variation that is in a way other than as set out in the original application for variation. 18

Item 17 After paragraph 8S(2)(a) of the Code set out in the Schedule Item 17 amends subsection 8S(2) of the Agvet Code to insert new paragraph 8S(2)(b) of the Agvet Code. Subsection 8S(2) of the Agvet Code currently provides that the written notice issued under subsection 8S(1) of the Agvet Code must contain a number of matters, which are currently set out by paragraphs 8S(2)(a), (c), (d) and (e) of the Agvet Code. New paragraph 8S(2)(b) of the Agvet Code provides that the written notice issued under subsection 8S(1) of the Agvet Code must, for a notice issued under new paragraph 8S(1)(c) of the Agvet Code, set out the proposed variation. New paragraph 8S(1)(c) of the Agvet Code is inserted by item 16 above, and provides that the APVMA must give an applicant written notice of what it proposes to do before it varies, under section 29 of the Agvet Code, relevant particulars or conditions in a way other than as set out in the original application. New paragraph 8S(2)(b) of the Agvet Code is necessary to ensure an applicant receives a copy of the proposed variation so that they may provide written submissions to the APVMA about the proposed variation. Item 17 complements the amendments to section 8S of the Agvet Code by item 16 above. Item 18 Paragraphs 29(1)(b), (c) and (d) of the Code set out in the Schedule Item 18 omits the references to "in accordance with the application" in paragraphs 29(1)(b), (c) and (d) of the Agvet Code, and substitutes those references with references to "in a particular way (which may not be the same way as set out in the application)". Item 18 will provide applicants and the APVMA with greater flexibility in relation to the variation of relevant particulars and conditions of an approval of an active constituent, a registration of a chemical product, or an approval of a label for containers for a chemical product. The proposed amendments will enable that variation to occur in a way that is different than what was originally set out in the application, while still ensuring the statutory criteria and established product standards are complied with. It is important to note that the amendments to section 8S of the Agvet Code by items 16 and 17 above will ensure that an applicant has the opportunity to provide a written submission to the APVMA on a proposed variation that is in a way other than as set out in the original variation application. Item 19 After paragraph 167(1)(c) of the Code set out in the Schedule Item 19 amends subsection 167(1) of the Agvet Code to insert new paragraph 167(1)(c) of the Agvet Code. Subsection 167(1) of the Agvet Code currently identifies a number of decisions of the APVMA that are reviewable decisions internally and by the Administrative Appeals Tribunal. New paragraph 167(1)(ca) of the Agvet Code provides that an application may be made to the APVMA for internal review and the Administrative Appeals Tribunal of decisions under subsection 29(1) of the Agvet Code to vary relevant particulars or conditions in a way other than as set out in the original application for variation. 19

Subsection 29(1) of the Agvet Code currently requires the APVMA to vary the relevant particulars or conditions of an approval of an active constituent, a registration of a chemical product, or an approval of a label for containers for a chemical product, if it is satisfied of a number of matters, which are currently set out by paragraphs 29(1)(a) to (d) of the Agvet Code. New paragraph 167(1)(ca) of the Agvet Code is necessary to enable an affected applicant to apply to the Administrative Appeals Tribunal for review of a decision made by the APVMA under subsection 29(1) of the Agvet Code to vary relevant particulars or conditions in a way other than as set out in the original application for variation. It is appropriate that subsection 167(1) of the Agvet Code be amended to provide a pathway for applicants to seek merits review of such a decision by the APVMA, as an applicant could be affected by such a decision. Subsection 167(3) of the Agvet Code provides that section 167 of the Agvet Code has effect subject to the Administrative Appeals Tribunal Act 1975. Accordingly, the provisions of that Act will apply to new paragraph 167(1)(ca) of the Agvet Code. Item 20 Application provision Item 20 provides that the amendments made by Part 3 of Schedule 1 to the Bill will apply in relation to applications lodged under section 27 of the Agvet Code on or after the commencement of Part 3 of Schedule 1 to the Bill. Part 3 of Schedule 1 to the Bill will commence on the day after the end of the period of three months beginning on the day the Bill receives the Royal Assent. Deferring commencement for three months for Part 3 of Schedule 1 to the Bill is necessary to ensure the APVMA has sufficient time to appropriately implement necessary changes to policies, procedures and training protocols as a result of the amendments. Item 20 ensures that the amendments proposed by Part 3 of Schedule 1 to the Bill will not apply retrospectively. 20

PART 4--VARIATION OF LABEL APPROVAL WHILE APPROVAL SUSPENDED Overview Part 4 of Schedule 1 to the Bill seeks to amend the Agvet Code to enable the APVMA to vary a label approval where that approval is suspended. This amendment will ensure that the issue or issues with a label approval that led to its suspension can be appropriately rectified prior to revocation of the suspension. Currently, under Division 5 of Part 2 of the Agvet Code, the APVMA may suspend an approval for a label for containers for a chemical product. Subsection 43(2) of the Agvet Code relevantly provides that an approval or registration is taken, for the purposes of the Agvet Code, other than sections 74 and 75 of the Agvet Code, not to be in force during any period in which it is suspended. Division 3 of Part 2 of the Agvet Code currently sets out matters in relation to varying relevant particulars and conditions of approvals and registrations, which includes variations to label approvals. However, the APVMA cannot currently amend a label to address the problem that led to the requirement to suspend the label approval without first revoking the suspension. The proposed amendments seek to remedy this unintended administrative barrier to the appropriate rectification of issues with suspended label approvals. Agricultural and Veterinary Chemicals Code Act 1994 Item 21 Subsection 43(2) of the Code set out in the Schedule Item 21 omits the reference to "An" in subsection 43(2) of the Agvet Code, and substitutes that reference with a reference to "Subject to this section, an". Subsection 43(2) of the Agvet Code currently provides that an approval or registration is taken, for the purposes of the Agvet Code, other than sections 74 and 75 of the Agvet Code, not to be in force during any period in which it is suspended. Item 21 is consequential to the amendment to section 43 of the Agvet Code by item 22 below. Item 22 At the end of section 43 of the Code set out in the Schedule Item 22 amends section 43 of the Agvet Code to insert new subsections 43(4) and (5) of the Agvet Code. Section 43 of the Agvet Code provides for matters in relation to the effect of a suspension of an approval or registration. Currently, under Division 5 of Part 2 of the Agvet Code, the APVMA may suspend an approval for a label for containers for a chemical product. Subsection 43(2) of the Agvet Code relevantly provides that an approval or registration is taken, for the purposes of the Agvet Code, other than sections 74 and 75 of the Agvet Code, not to be in force during any period in which it is suspended. Division 3 of Part 2 of the Agvet Code currently sets out matters in relation to varying relevant particulars and conditions of approvals and registrations, which includes variations to label approvals. However, the APVMA cannot currently amend a label to address the problem or problems that led to the requirement to suspend the label approval without first revoking the suspension. 21

New subsection 43(4) of the Agvet Code ensures that, despite the suspension of an approval of a label for containers for a chemical product, a person is not prevented from lodging a notice, making an application or seeking a variation of the relevant particulars or conditions of that label approval. This amendment will ensure that the issue or issues with a label approval that led to its suspension could be appropriately rectified prior to revocation of the suspension. New subsection 43(5) of the Agvet Code provides that a notice referred to in new paragraph 43(4)(a) of the Agvet Code, an application referred to in new paragraphs 43(4)(b) or (c) of the Agvet Code, or a variation referred to in new paragraph 43(4)(d) of the Agvet Code must be in relation to the reasons for the suspension of the approval. New subsection 43(5) of the Agvet Code ensures that the notice, application or variation appropriately relates to the issue or issues with a label approval that led to its suspension. Item 23 Subsection 45A(2) of the Code set out in the Schedule Item 23 omits the reference to "subsection (1)" in subsection 45A(2) of the Agvet Code, and substitutes that reference with a reference to "paragraph (1)(a)". Subsection 45A(2) of the Agvet Code currently provides that a notice of suspension or cancellation under subsection 45A(1) of the Agvet Code must contain a number of matters, which are currently set out by paragraphs 45A(2)(a) and (b) of the Agvet Code. Item 23 ensures that subsection 45A(2) of the Agvet Code correctly identifies the provision under which the applicable notice of suspension or cancellation is issued. As paragraph 45A(1)(b) of the Agvet Code currently relates to the publication of a notice of suspension or cancellation, it is appropriate that subsection 45A(2) of the Agvet Code be amended to expressly refer to paragraph 45A(1)(a) of the Agvet Code. Item 24 Paragraph 45A(2)(b) of the Code set out in the Schedule Item 24 omits the reference to "in respect of a suspension or cancellation of the approval of an active constituent for a proposed or existing chemical product or the registration of a chemical product--" from paragraph 45A(2)(b) of the Agvet Code. Paragraph 45A(2)(b) of the Agvet Code currently provides that a notice or suspension or cancellation under subsection 45A(1) of the Agvet Code, in respect of a suspension or cancellation of the approval of an active constituent for a proposed or existing chemical product or the registration of a chemical product must contain certain matters, which are currently set out by subparagraphs 45A(2)(b)(i) to (iv) of the Agvet Code. Accordingly, a notice of cancellation or suspension of the approval of a label is not subject to the same notification requirements as a notice of cancellation or suspension of the approval of an active constituent for a proposed or existing chemical product or the registration of a chemical product, which are currently set out by paragraph 45A(2)(b) of the Agvet Code. It is necessary to amend paragraph 45A(2)(b) of the Agvet Code to enable the requirements in that paragraph to apply to a notice of suspension or cancellation of a label approval. This will ensure that notices of suspension or cancellation for approvals of active constituents, registrations of chemical products or approvals of labels are treated consistently. 22

Item 25 Application provisions Sub-item 25(1) provides that the amendments to section 43 of the Agvet Code by items 21 and 22 above will apply in relation to: (a) a suspension made on or after the commencement of Part 4 of Schedule 1 to the Bill; and (b) a suspension made before the commencement of Part 4 of Schedule 1 to the Bill that was in effect immediately before that commencement. Part 4 of Schedule 1 to the Bill will commence on the day after the end of the period of three months beginning on the day the Bill receives the Royal Assent. Deferring commencement for three months for Part 4 of Schedule 1 to the Bill is necessary to ensure the APVMA has sufficient time to appropriately implement necessary changes to policies, procedures and training protocols as a result of the amendments. It is appropriate that the amendments to section 43 of the Agvet Code by items 21 and 22 above apply to a suspension made before the commencement of Part 4 of Schedule 1 to the Bill that was in effect immediately before that commencement because it will ensure any existing suspended label approvals are also able to access the ability to address underlying issues in order to have the suspension lifted. Sub-item 25(2) provides that the amendments to section 45A of the Agvet Code by items 23 and 24 above will apply in relation to a suspension or cancellation made on or after the commencement of Part 4 of Schedule 1 to the Bill. As noted above, Part 4 of Schedule 1 to the Bill will commence on the day after the end of the period of three months beginning on the day the Bill receives the Royal Assent. Sub-item 25(2) ensures that the proposed amendments to section 45A of the Agvet Code by items 23 and 24 above will not apply retrospectively. 23

PART 5--FALSE AND MISLEADING INFORMATION Overview Part 5 of Schedule 1 to the Bill seeks to amend the Administration Act and the Agvet Code to establish civil pecuniary penalties for contraventions of provisions relating to false or misleading information. Currently, under section 69ER of the Administration Act and section 146 of the Agvet Code, a person commits an offence if that person gives false or misleading information or produces false or misleading documents. Unlike other provisions in the Administration Act and the Agvet Code, section 69ER of the Administration Act and section 146 of the Agvet Code do not also subject that conduct to civil pecuniary penalties. The absence of civil pecuniary penalties for a contravention of section 69ER of the Administration Act or a contravention of section 146 of the Agvet Code reduces the enforcement tools available to the APVMA. Accordingly, the creation of civil pecuniary penalties for those provisions encourages compliance with the Administration Act and the Agvet Code, and provides greater flexibility for the APVMA to proportionately respond to circumstances of non-compliance. Agricultural and Veterinary Chemicals (Administration) Act 1992 Item 26 Before subsection 69ER(1) Item 26 amends section 69ER of the Administration Act to insert a new subheading before current subsection 69ER(1) of that Act. The new subheading, Offences, will assist the reader to identify that subsections 69ER(1) and (2) of the Administration Act are offence provisions, and also ensures that section 69ER of the Administration Act, as amended by item 27 below, is structured consistently. Item 27 At the end of section 69ER Item 27 amends section 69ER of the Administration Act to insert new subsections 69ER(3), (4) and (5) of that Act. Item 27 also inserts the subheading, Civil penalties, for those new subsections. Section 69ER of the Administration Act currently provides for offences in relation to the giving or production of false or misleading information or documents. Subsections 69ER(1) and (2) of the Administration Act detail these offences and the relevant penalties (300 and 60 penalty units, depending on the offence). New subsections 69ER(3) and (4) of the Administration Act respectively complement current subsections 69ER(1) and (2) of that Act, by creating corresponding civil penalty provisions for the same conduct. New subsection 69ER(5) of the Administration Act provides that new subsections 69ER(3) and (4) of that Act are civil penalty provisions. Item 27 also inserts a note at the end of new subsection 69ER(5) of the Administration Act to direct the reader to Division 1 of Part 7AB of that Act. This creates a framework to use civil pecuniary penalties to enforce the civil penalty provisions of the Administration Act and the 24

Levy Act (see the definition of civil penalty provision in section 4 of the Administration Act). The note to new subsection 69ER(5) of the Administration Act is merely included to assist the reader. Subsection 69EJA(1) of the Administration Act provides that the pecuniary penalty for a contravention of a civil penalty provision by a body corporate must not exceed five times the amount of the maximum monetary penalty that could be imposed by a court if the body corporate were convicted of an offence constituted by conduct that is the same as the conduct constituting the contravention. Subsection 69EJA(2) of the Administration Act provides that the pecuniary penalty for a contravention of a civil penalty provision by an individual must not exceed three times the amount of the maximum monetary penalty that could be imposed by a court if the person were convicted of an offence constituted by conduct that is the same as the conduct constituting the contravention. It is important to note that subsection 69EJA(1) of the Administration Act refers to the maximum monetary penalty that could be imposed by a court if a body corporate were convicted of an offence constituted by conduct that is the same as the conduct constituting the contravention. Subsection 4B(3) of the Crimes Act states that, where a body corporate is convicted of an offence against a law of the Commonwealth, a court may, if the contrary intention does not appear and the court thinks fit, impose a pecuniary penalty not exceeding an amount equal to five times the amount of the maximum pecuniary penalty that could be imposed by the court on a natural personal convicted of the same offence. The applicable criminal pecuniary penalty for an individual for a contravention of current subsection 69ER(1) of the Administration Act is 300 penalty units. The applicable criminal pecuniary penalty for an individual for a contravention of current subsection 69ER(2) of the Administration Act is 60 penalty units. Accordingly, as there is no contrary intention in the Administration Act, the corresponding criminal pecuniary penalty for a body corporate for a contravention of current subsection 69ER(1) of the Administration Act will be 1,500 penalty units, and the corresponding criminal pecuniary penalty for a body corporate for a contravention of current subsection 69ER(2) of the Administration Act will be 300 penalty units. By virtue of section 69EJA of the Administration Act, and the matters prescribed by current subsection 69ER(1) of the Administration Act (including the application of subsection 4B(3) of the Crimes Act to that subsection), the civil pecuniary penalty for new subsection 69ER(3) of that Act will be 900 penalty units for individuals and 7,500 penalty units for bodies corporate. New subsection 69ER(3) of the Administration Act is necessary to achieve the legitimate objective of protecting human and animal health, the environment and trade. Subjecting the conduct in new subsection 69ER(3) of the Administration Act to a civil pecuniary penalty of 900 penalty units for individuals and 7,500 penalty units for bodies corporate provides a necessary and proportionate deterrent to non-compliance with the requirement in that new subsection not to give false or misleading information or documents. Further, the proposed 25

penalties are reflective of the seriousness of the conduct and the risk that contravening behaviour may pose to human and animal health, the environment and trade. By virtue of section 69EJA of the Administration Act, and the matters prescribed by current subsection 69ER(2) of the Administration Act (including the application of subsection 4B(3) of the Crimes Act to that subsection), the civil pecuniary penalty for new subsection 69ER(4) of that Act will be 180 penalty units for individuals and 1,500 penalty units for bodies corporate. New subsection 69ER(4) of the Administration Act is necessary to achieve the legitimate objective of protecting human and animal health, the environment and trade. Subjecting the conduct in new subsection 69ER(4) of the Administration Act to a civil pecuniary penalty of 180 penalty units for individuals and 1,500 penalty units for bodies corporate provides a necessary and proportionate deterrent to non-compliance with the requirement in that new subsection not to give false or misleading information or documents. Further, the proposed penalties are reflective of the seriousness of the conduct and the risk that contravening behaviour may pose to human and animal health, the environment and trade Further the proposed penalties in new subsections 69ER(3) and (4) are significantly less than the civil pecuniary penalties prescribed by section 31AAA of the Therapeutic Goods Act for similar conduct in relation to the provision of false or misleading information or documents, which are 5,000 penalty units for individuals and 50,000 penalty units for bodies corporate. This reflects the lower amounts for the current offences in relation to the provision of false or misleading information or documents in the Administration Act. New subsections 69ER(3) and (4) of the Administration Act seek to encourage compliance with that Act, and will provide the APVMA with greater flexibility to proportionately respond to circumstances of non-compliance. Agricultural and Veterinary Chemicals Code Act 1994 Item 28 Before subsection 146(1) of the Code set out in the Schedule Similar to item 26 above, item 28 amends section 146 of the Agvet Code to insert a new subheading before current subsection 146(1) of the Agvet Code. The new subheading, Offences, will assist the reader to identify that subsections 146(1) and (2) of the Agvet Code are offence provisions, and also ensures that section 146 of the Agvet Code, as amended by item 29 below, is structured consistently. Item 29 At the end of section 146 of the Code set out in the Schedule Similar to item 27 above, item 29 amends section 146 of the Agvet Code to insert new subsections 146(3), (4) and (5) of the Agvet Code. Item 29 also inserts the subheading, Civil penalties, for those new subsections. Section 146 of the Agvet Code currently provides for offences in relation to the giving or production of false or misleading information or documents. Subsections 146(1) and (2) of the Agvet Code detail these offences and the relevant penalties (300 and 60 penalty units, depending on the offence). 26

New subsection 146(3) and (4) of the Agvet Code respectively complement current subsections 146(1) and (2) of the Agvet Code, by creating corresponding civil penalty provisions for the same conduct. New subsection 146(5) of the Agvet Code provides that new subsections 146(3) and (4) of the Agvet Code are civil penalty provisions. Item 29 also inserts a note at the end of new subsection 146(4) of the Agvet Code to direct the reader to Division 2 of Part 9A of the Agvet Code, which creates a framework for the use of civil pecuniary penalties to enforce the civil penalty provisions of the Agvet Code. Subsection 145AA(1) of the Agvet Code provides that the pecuniary penalty for a contravention of a civil penalty provision by a body corporate must not exceed five times the amount of the maximum monetary penalty that could be imposed by a court if the body corporate were convicted of an offence constituted by conduct that is the same as the conduct constituting the contravention. Subsection 145AA(2) of the Agvet Code provides that the pecuniary penalty for a contravention of a civil penalty provision by an individual must not exceed three times the amount of the maximum monetary penalty that could be imposed by a court if the person were convicted of an offence constituted by conduct that is the same as the conduct constituting the contravention. It is important to note that subsection 145AA(1) of the Agvet Code refers to the maximum monetary penalty that could be imposed by a court if a body corporate were convicted of an offence constituted by conduct that is the same as the conduct constituting the contravention. Subsection 170(5) of the Agvet Code states that, where a body corporate is convicted of an offence against the Agvet Code, a court may, if the court thinks fit, impose a monetary penalty not greater than five times the amount of the maximum monetary penalty that could be imposed by the court on an individual convicted of the same offence. The applicable criminal pecuniary penalty for an individual for a contravention of current subsection 146(1) of the Agvet Code is 300 penalty units. The applicable criminal pecuniary penalty for an individual for a contravention of current subsection 146(2) of the Agvet Code is 60 penalty units. Due to subsection 170(5) of the Agvet Code, the corresponding criminal pecuniary penalty for a body corporate for a contravention of current subsection 146(1) of the Agvet Code will be 1,500 penalty units, and the corresponding criminal pecuniary penalty for a body corporate for a contravention of current subsection 146(2) of the Agvet Code will be 300 penalty units. By virtue of section 145AA of the Agvet Code, and the matters prescribed by current subsection 146(1) of the Agvet Code (including the application of subsection 4B(3) of the Crimes Act to that subsection), the civil pecuniary penalty for new subsection 146(3) of the Agvet Code will be 900 penalty units for individuals and 7,500 penalty units for bodies corporate. New subsection 146(3) of the Agvet Code is necessary to achieve the legitimate objective of protecting human and animal health, the environment and trade. Subjecting the conduct in new subsection 146(3) of the Agvet Code to a civil pecuniary penalty of 900 penalty units for 27

individuals and 7,500 penalty units for bodies corporate provides a necessary and proportionate deterrent to non-compliance with the requirement in that new subsection not to give false or misleading information or documents. Further, the proposed penalties are reflective of the seriousness of the conduct and the risk that contravening behaviour may pose to human health and safety, the environment and trade if agvet chemicals are used inappropriately on the basis of false or misleading information or documents. By virtue of section 145AA of the Agvet Code, and the matters prescribed by current subsection 146(2) of the Agvet Code, the civil pecuniary penalty for new subsection 146(4) of the Agvet Code will be 180 penalty units for individuals and 1,500 penalty units for bodies corporate. New subsection 146(4) of the Agvet Code is necessary to achieve the legitimate objective of protecting human and animal health, the environment and trade. Subjecting the conduct in new subsection 146(4) of the Agvet Code to a civil pecuniary penalty of 180 penalty units for individuals and 1,500 penalty units for bodies corporate provides a necessary and proportionate deterrent to non-compliance with the requirement in that new subsection not to give false or misleading information or documents. Further, the proposed penalties are reflective of the seriousness of the conduct and the risk that contravening behaviour may pose to human health and safety, the environment and trade if agvet chemicals are used inappropriately on the basis of false or misleading information or documents. Further, the proposed penalties for new subsections 146(3) and (4) are significantly less than the civil pecuniary penalties prescribed by section 31AAA of the Therapeutic Goods Act for similar conduct in relation to the provision of false or misleading information or documents, which are 5,000 penalty units for individuals and 50,000 penalty units for bodies corporate. This reflects the lower amounts for the current offences in relation to the provision of false or misleading information or documents in the Agvet Code. New subsections 146(3) and (4) of the Agvet Code seek to encourage compliance with the Agvet Code, and will provide the APVMA with greater flexibility to proportionately respond to circumstances of non-compliance. Item 30 Application provision Item 30 provides that the amendments made by Part 5 of Schedule 1 to the Bill will apply in relation to information given, or a document produced, on or after the commencement of Part 5 of Schedule 1 to the Bill. Part 5 of Schedule 1 to the Bill will commence on the day after the end of the period of three months beginning on the day the Bill receives the Royal Assent. Deferring commencement for three months for Part 5 of Schedule 1 to the Bill is necessary to ensure the APVMA has sufficient time to appropriately implement necessary changes to policies, procedures and training protocols as a result of the amendments. Further, delayed commencement will also ensure that affected persons are appropriately notified of the amendments and corresponding penalties for non-compliance. Item 30 ensures that the amendments proposed by Part 5 of Schedule 1 to the Bill will not apply retrospectively. 28

PART 6--NOTIFICATION ABOUT VARIATION TO MAXIMUM RESIDUE LIMITS STANDARD Overview Part 6 of Schedule 1 to the Bill seeks to amend when notification must be provided to FSANZ by the APVMA in relation to an approval, registration, variation or permit under the Agvet Code. The proposed amendment seeks to require the APVMA to notify FSANZ where an approval, registration, variation or permit would, if given, made or issued be likely to require a corresponding variation to the Maximum Residue Limits Standard. The proposed amendment will also provide the APVMA and FSANZ with the flexibility to agree on appropriate timeframes for notification. Agricultural and Veterinary Chemicals Code Act 1994 Item 31 Paragraph 8E(2)(c) of the Code set out in the Schedule Item 31 repeals paragraph 8E(2)(c) of the Agvet Code and inserts a new paragraph 8E(2)(c) of the Agvet Code. Subsections 8E(1) and (2) of the Agvet Code currently provide that the APVMA must notify FSANZ within 28 days if an approval, registration, variation or permit proposed under the Agvet Code (whether by application or on the initiative of the APVMA) would, if it were given, made or issued, be likely to require a variation to the Maximum Residue Limits Standard. New paragraph 8E(2)(c) of the Agvet Code provides that the notice of an approval, registration, variation or permit proposed under the Agvet Code would, if it were given, made or issued, be likely to require a variation to the Maximum Residue Limit Standard, must be given to FSANZ before it is given, made or issued. Accordingly, item 31 removes the current 28 day notification timeframe in subparagraph 8E(2)(c)(i) of the Agvet Code. New paragraph 8E(2)(c) of the Agvet Code seeks to ensure that the notification requirements for proposed approvals, registrations, variations or permit applications are treated consistently. New paragraph 8E(2)(c) of the Agvet Code will provide the APVMA and FSANZ with the flexibility to liaise and agree on appropriate timeframes. This will enable the APVMA to assess whether a variation to the Maximum Residue Limit Standard is likely to be required due to the giving, making or issuing of an approval, registration, variation or permit under the Agvet Code, while still providing FSANZ with appropriate time to consider the notification and undertake any necessary preparatory work. Item 32 Application provision Item 32 provides that the repeal and substitution of paragraph 8E(2)(c) of the Agvet Code by item 31 above will apply in relation to notifications on or after the commencement of Part 6 of Schedule 1 to the Bill. Part 6 of Schedule 1 to the Bill commences on the day after the Bill receives the Royal Assent. Item 32 is consequential to the repeal and substitution of paragraph 8E(2)(c) of the Agvet Code by item 31 above, and ensures that the proposed amendment will not apply retrospectively. 29

PART 7--EXPIRY DATE Overview Part 7 of Schedule 1 to the Bill seeks to amend the definition of expiry date in section 3 of the Agvet Code to clarify that the expiry date is the date after which a chemical product must not be used. The proposed amendment seeks to ensure that the expiry date reflects the timeframe in which the use of a chemical product is safe, effective and does not cause unmanageable risks. Agricultural and Veterinary Chemicals Code Act 1994 Item 33 Section 3 of the Code set out in the Schedule (definition of expiry date) Item 33 omits the reference to "should" in the definition of expiry date in section 3 of the Agvet Code, and substitutes that reference with a reference to "must". Section 3 of the Agvet Code defines expiry date, in relation to the contents of a container, to mean the month and year after which the contents should not be used. Item 33 clarifies that the expiry date for a date-controlled chemical product is the date after which a chemical product must not be used. Section 3 of the Agvet Code defines date-controlled chemical product to mean a chemical product declared by the regulations made under section 6 of the Code Act to be a date-controlled chemical product. Schedule 1 to the Agvet Code Regulations declares certain chemical products to be date-controlled chemical products. The proposed amendment seeks to ensure that the definition of expiry date reflects the timeframe in which the use of a chemical product is safe, effective and does not cause unmanageable risks. Item 34 Application provision Item 34 provides that the amendment to the definition of expiry date in section 3 of the Agvet Code by item 33 above will apply in relation to a supply referred to in subsections 85(1), 91(1) or (2) of the Agvet Code that occurs on or after the commencement of Part 7 of Schedule 1 to the Bill. Part 7 of Schedule 1 to the Bill commences on the day after the Bill receives the Royal Assent. Item 34 is consequential to the amendment to the definition of expiry date in section 3 of the Agvet Code by item 33 above, and ensures that the proposed amendment will not apply retrospectively. 30

PART 8--OTHER AMENDMENTS Overview Part 8 of Schedule 1 to the Bill seeks to repeal Part 7B of the Administration Act and makes minor and technical amendments to the Agvet Code. Part 7B of the Administration Act is redundant and no longer necessary to retain. Agricultural and Veterinary Chemicals (Administration) Act 1992 Item 35 Part 7B Item 35 repeals Part 7B of the Administration Act. Part 7B of the Administration Act currently provides for the modification of the Agvet Code for the purpose of giving effect to paragraph 3 of Article 39 of the Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement). Part 7B of the Administration Act became redundant in November 2016 because there are no longer any applications remaining to which Part 7B of that Act could apply. As there are no longer any applications before the APVMA to which Part 7B of the Administration Act could apply, it is no longer necessary to retain Part 7B of the Administration Act. Item 36 Saving provision Item 36 provides that, despite the repeal of Part 7B of the Administration Act by item 35 above, an approval referred to in section 69EZ of the Administration Act, as in force immediately before the commencement of Part 8 of Schedule 1 to the Bill, continues to apply on and after that commencement in relation to an approval that was given before that commencement. Part 8 of Schedule 1 to the Bill commences on the day after the Bill receives the Royal Assent. Item 36 preserves the effect of section 69EZ of the Administration Act for the purposes of applications that have been granted but would have otherwise been prohibited by section 69EY of that Act. Item 36 is consequential to the repeal of Part 7B of the Administration Act by item 35 above. Agricultural and Veterinary Chemicals Code Act 1994 Item 37 Subparagraph 8A(a)(v) of the Code set out in the Schedule Item 37 omits the reference to "subparagraph." in subparagraph 8A(a)(v) of the Agvet Code, and substitutes that reference with a reference to "subparagraph; and". Section 8A of the Agvet Code currently provides for the definition of meets the application requirements. Subparagraph 8A(a)(v) of the Agvet Code currently forms part of a list in section 8A of the Agvet Code and the full stop currently at the end of subparagraph 8A(a)(v) of the Agvet Code appears to conclude the list. As there are other paragraphs after subparagraph 8A(a)(v) of the Agvet Code that form part of the definition of meets the application requirements, it is appropriate that subparagraph 8A(a)(v) of the Agvet Code be amended to include a semi-colon at the end of that subparagraph. Item 38 Subsection 46(1) of the Code set out in the Schedule Item 38 omits the reference to "relevant file" in subsection 46(1) of the Agvet Code, and substitutes that reference with a reference to "relevant APVMA file". 31

It is necessary to amend subsection 46(1) of the Agvet Code to replace the reference to "relevant file" with a reference to "relevant APVMA file" so it is clear that the file referred to in subsection 46(1) of the Agvet Code is the same file defined by section 3 of the Agvet Code. Item 38 ensures that consistent terminology is used throughout the Agvet Code and seeks to overcome any ambiguity in interpreting subsection 46(1) of the Agvet Code. Item 39 Paragraph 51(c) of the Code set out in the Schedule Item 39 omits the reference to "relevant file" in paragraph 51(c) of the Agvet Code, and substitutes that reference with a reference to "relevant APVMA file". It is necessary to amend paragraph 51(c) of the Agvet Code to replace the reference to "relevant file" with a reference to "relevant APVMA file" so it is clear that the file referred to in paragraph 51(c) of the Agvet Code is the same file defined by section 3 of the Agvet Code. Item 39 ensures that consistent terminology is used throughout the Agvet Code and seeks to overcome any ambiguity in interpreting paragraph 51(c) of the Agvet Code. 32

STATEMENT OF COMPATIBILITY WITH HUMAN RIGHTS Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011. Agricultural and Veterinary Chemicals Legislation Amendment (Operational Efficiency) Bill 2017 This Bill 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. Overview of the Bill The Bill makes amendments to the Administration Act, the Code Act and the Levy Act to:  reduce the regulatory burden on industry by simplifying reporting requirements for annual returns;  reduce the administrative burden on the APVMA and industry by increasing the flexibility of the APVMA to manage errors in an application at the preliminary assessment stage;  reduce the regulatory burden by enabling the APVMA to grant part of a variation application under section 27 of the Agvet Code;  enable a person to apply to vary the relevant particulars or conditions of a label approval that is suspended, to the extent that the variation relates to the matters relating to the grounds for suspension;  establish civil pecuniary penalties for contraventions of provisions relating to providing false or misleading information in the Agvet Code and the Administration Act;  amend the notification requirements in section 8E of the Agvet Code so that the APVMA and FSANZ will have the flexibility to agree on appropriate timeframes for notification;  amend the definition of expiry date in the Agvet Code to mean the date after which a chemical product 'must not' be used;  make minor and technical amendments to the Administration Act and the Agvet Code, including to repeal redundant provisions. Human rights implications The Bill engages, or has the potential to engage, the following rights:  Articles 2, 6, 9, 14, 15 and 17 of the International Covenant on Civil and Political Rights (ICCPR). Part 1 of Schedule 1--Annual returns and record-keeping Right to the presumption of innocence (strict liability offences) Article 14(2) of the ICCPR states that everyone charged with a criminal offence shall have the right to be presumed innocent until proven guilty according to law. The right to the presumption of innocence is also a fundamental common law principle in Australia. When strict liability applies to an offence, the prosecution is only required to prove the physical elements of an offence. That is, they are not required to prove fault elements in order for the defendant to be found guilty. Strict liability is used in circumstances where there is a public interest in ensuring that regulatory schemes are observed and it can be reasonably expected that the person was aware of their duties and obligations. Strict liability offences can be considered a limitation of the presumption of innocence because the defendant can be 33

found guilty without the prosecution being required to prove fault. It is important to note that the defence of honest and reasonable mistake of fact is available to the defendant (see section 9.2 of the Criminal Code). Strict liability offences will not necessarily be inconsistent with the presumption of innocence, provided that the removal of the presumption of innocence pursues a legitimate objective and is reasonable, necessary and proportionate to achieving that objective. Whether a strict liability provision impermissibly limits the right to the presumption of innocence will depend on the circumstances of the case and the particular justification for an offence being a strict liability offence. Part 1 of Schedule 1 to the Bill proposes to establish strict liability offences in relation to new sections 35 and 37 of the Levy Act. The application of strict liability in Part 1 of Schedule 1 to the Bill, and the offences to which it relates, has been developed in line with the Guide to Framing Commonwealth Offences. New subsection 35(3) of the Levy Act provides that a person commits an offence of strict liability, which is subject to a criminal pecuniary penalty of 50 penalty units, if that person contravenes new subsection 35(1) of the Levy Act. New subsection 35(1) of the Levy Act provides that an interested person in relation to a chemical product who is liable to pay levy in respect of leviable disposals of that product that took place anywhere in Australia at any time during a financial year, must give to the APVMA, before 30 November in the next financial year, a return setting out the total quantity of the chemical product covered by those leviable disposals. The term interested person is currently defined by subsection 3(1) of the Levy Act. It is important to note that the applicable pecuniary penalty of 50 penalty units in new subsection 35(3) of the Levy Act is the maximum criminal pecuniary penalty that a relevant court could impose on an individual for a contravention of new subsection 35(3) of the Levy Act. Subsection 4B(3) of the Crimes Act states that, where a body corporate is convicted of an offence against a law of the Commonwealth, a court may, if the contrary intention does not appear and the court thinks fit, impose a pecuniary penalty not exceeding an amount equal to five times the amount of the maximum pecuniary penalty that could be imposed by the court on a natural personal convicted of the same offence. Accordingly, as there is no contrary intention in the Levy Act, the corresponding maximum criminal pecuniary penalty that a relevant court could impose on a body corporate for a contravention of new subsection 35(1) of the Levy Act will be 250 penalty units. New subsection 37(2) of the Levy Act provides that a person commits an offence of strict liability, which is subject to a criminal pecuniary penalty of 50 penalty units, if that person contravenes new subsection 37(1) of the Levy Act. 34

New subsection 37(1) of the Levy Act provides that the interested person in relation to a chemical product who is liable to pay levy in respect of leviable disposals of the chemical product that took place anywhere in Australia at any time during a financial year must: (a) keep any records relating to those disposals that are reasonably necessary to enable the APVMA to find out whether new section 35 of the Levy Act has been complied with; and (b) retain those records for six years. It is important to note that the applicable pecuniary penalty of 50 penalty units in new subsection 37(2) of the Levy Act is the maximum criminal pecuniary penalty that a relevant court could impose on an individual for a contravention of new subsection 37(1) of the Levy Act. Due to the application of subsection 4B(3) of the Crimes Act to the Levy Act, the corresponding maximum criminal pecuniary penalty that a relevant court could impose on a body corporate for a contravention of new subsection 37(1) of the Levy Act will be 250 penalty units. The Levy Act, the Administration Act and the Code Act form part of the cooperative Commonwealth legislative framework that provides for the evaluation, registration and control of agvet chemical products. The Levy Act pursues the legitimate objective of supporting the broader regulatory framework of that legislative scheme by providing for the assessment and collection of levies in relation to agricultural and veterinary chemical products. It is necessary to prescribe a contravention of new subsection 35(1) of the Levy Act as an offence of strict liability, with a corresponding criminal pecuniary penalty of 50 penalty units for individuals and 250 penalty units for bodies corporate, to achieve the legitimate objective of the Levy Act, as it ensures that interested persons liable to pay levy provide appropriate information to the APVMA about the leviable disposal of chemical products. It is necessary to prescribe a contravention of new subsection 37(1) of the Levy Act as an offence of strict liability, with a corresponding criminal pecuniary penalty of 50 penalty units for individuals and 250 penalty units for bodies corporate, to achieve the legitimate objective of the Levy Act. This ensures that interested persons liable to pay levy keep appropriate records relating to leviable disposals that can substantiate information provided to the APVMA about those disposals. New subsections 35(1) and 37(1) of the Levy Act ensure that the APVMA has access to information that is necessary for the ongoing regulation of agvet chemicals. The strict liability offences proposed by new subsections 35(3) and 37(2) of the Levy Act are reasonable and proportionate to the legitimate objective of that Act because the offences are not punishable by imprisonment and the proposed penalties are low (50 penalty units for individuals and 250 penalty units for bodies corporate). Further, punishment of the proposed strict liability offences is likely to significantly enhance the effectiveness of the enforcement regime of the Levy Act by deterring interested persons from not providing annual returns to the APVMA or not keeping appropriate records to substantiate those annual returns. This will, in turn, ensure that the legitimate objective of the Levy Act is not frustrated due to the absence of necessary information about leviable disposals of chemical products. 35

Summary New subsections 35(3) and 37(2) of the Levy Act, as inserted by Part 1 of Schedule 1 to the Bill, are compatible with human rights because, to the extent that they may limit the right to be presumed innocent in Article 14(2) of the ICCPR, that limitation is reasonable, necessary and proportionate to the achievement of a legitimate objective. Civil penalties and Articles 14 and 15 New subsection 35(4) of the Levy Act provides that new subsection 35(1) of the Levy Act is a civil penalty provision. New subsection 35(1) of the Levy Act provides that an interested person in relation to a chemical product who is liable to pay levy in respect of leviable disposals of that product that took place anywhere in Australia at any time during a financial year, must give to the APVMA, before 30 November in the next financial year, a return setting out the total quantity of the chemical product covered by those leviable disposals. The term interested person is currently defined by subsection 3(1) of the Levy Act. New subsection 37(3) of the Levy Act provides that new subsection 37(1) of the Levy Act is a civil penalty provision. New subsection 37(1) of the Levy Act provides that the interested person in relation to a chemical product who is liable to pay levy in respect of leviable disposals of the chemical product that took place anywhere in Australia at any time during a financial year must: (a) keep any records relating to those disposals that are reasonably necessary to enable the APVMA to find out whether new section 35 of the Levy Act has been complied with; and (b) retain those records for six years. Prescribing conduct that is subject to a civil penalty could engage criminal process rights if the imposition of a civil penalty is classified as 'criminal' under international human rights law. Guidance Note 2: Offence provisions, civil penalties and human rights (December 2014), which is published by the Parliamentary Joint Committee on Human Rights, states that civil penalty provisions may engage criminal process rights under Articles 14 and 15 of the ICCPR, regardless of the distinction between criminal and civil penalties in domestic law. When a provision imposes a civil penalty, an assessment is required as to whether it amounts to a 'criminal' penalty for the purposes of the ICCPR. Determining whether penalties could be considered to be criminal under international human rights law requires consideration of the classification of the penalty provisions under Australian domestic law, the nature and purpose of the penalties, and the severity of the penalties. Items 2 and 3 in Part 1 of Schedule 1 to the Bill, which seek to insert new subsections 35(4) and 37(3) of the Levy Act, inserts notes at the end of those new subsections of the Levy Act. In particular, note 2 to new subsections 35(4) and 37(3) of the Levy Act directs the reader to Division 1 of Part 7AB of the Administration Act, which creates a framework for the use of civil penalties to enforce the civil penalty provisions of the Administration Act and the Levy Act (see the definition of civil penalty provision in section 4 of the Administration Act). Division 1 of Part 7AB of the Administration Act will apply to new subsections 35(4) and 37(3) of the Levy Act. Importantly, subsection 69EJA(1) of the Administration Act provides that the pecuniary penalty for a contravention of a civil penalty provision by a body corporate must not exceed 36

five times the amount of the maximum monetary penalty that could be imposed by a court if the body corporate were convicted of an offence constituted by conduct that is the same as the conduct constituting the contravention. Subsection 69EJA(2) of the Administration Act provides that the pecuniary penalty for a contravention of a civil penalty provision by an individual must not exceed three times the amount of the maximum monetary penalty that could be imposed by a court if the person were convicted of an offence constituted by conduct that is the same as the conduct constituting the contravention. New subsection 35(3) of the Levy Act provides that a person commits an offence of strict liability, which is subject to a criminal pecuniary penalty of 50 penalty units, if that person contravenes new subsection 35(1) of the Levy Act. New subsection 37(2) of the Levy Act provides that a person commits an offence of strict liability, which is subject to a criminal pecuniary penalty of 50 penalty units, if that person contravenes new subsection 37(1) of the Levy Act. It is important to note that subsection 69EJA(1) of the Administration Act refers to the maximum monetary penalty that could be imposed by a court if a body corporate were convicted of an offence constituted by conduct that is the same as the conduct constituting the contravention. Subsection 4B(3) of the Crimes Act states that, where a body corporate is convicted of an offence against a law of the Commonwealth, a court may, if the contrary intention does not appear and the court thinks fit, impose a pecuniary penalty not exceeding an amount equal to five times the amount of the maximum pecuniary penalty that could be imposed by the court on a natural personal convicted of the same offence. Accordingly, as there is no contrary intention in the Levy Act, the maximum criminal pecuniary penalty that a relevant court could impose on a body corporate for a contravention of new subsection 35(1) of the Levy Act will be 250 penalty units, due to the application of subsection 4B(3) of the Crimes Act to new subsection 35(3) of the Levy Act. Further, the maximum criminal pecuniary penalty that a relevant court could impose on a body corporate for a contravention of new subsection 37(1) of the Levy Act will be 250 penalty units, due to the application of subsection 4B(3) of the Crimes Act to new subsection 37(2) of the Levy Act. By virtue of section 69EJA of the Administration Act, and the matters prescribed by new subsections 35(3) and 37(2) of the Levy Act (including the application of subsection 4B(3) of the Crimes Act to those new subsections), the civil pecuniary penalty for new subsections 35(4) and 37(3) of the Levy Act will be 150 penalty units for individuals and 1250 penalty units for bodies corporate. The penalty provisions proposed by new subsections 35(4) and 37(3) of the Levy Act are expressly classified as civil penalty provisions. That is, new subsections 35(4) and 37(3) of the Levy Act seek to create solely pecuniary penalties in the form of a debt payable to the Commonwealth (see section 69EJB of the Administration Act). The purpose of new subsection 35(4) of the Levy Act is to encourage compliance with the requirement to submit annual returns to the APVMA, which is set out in new subsection 35(1) of the Levy Act. The purpose of new subsection 37(3) of the Levy Act is to encourage compliance with the requirement to keep records relating to leviable disposals, which is set out in new subsection 37(1) of the Levy Act. 37

The proposed civil penalty provisions do not seek to impose criminal liability, and do not lead to the creation of a criminal record. The penalties will only apply to those interested persons (as defined by subsection 3(1) of the Levy Act) who do not comply with the requirement to give annual returns to the APVMA (new subsection 35(1) of the Levy Act) or who do not keep records in relation to leviable disposals (new subsection 37(1) of the Levy Act). That is, the penalties will not apply to the public in general. Further, the imposition of the civil pecuniary penalties in new subsections 35(4) and 37(3) of the Levy Act are not dependent on a finding of guilt, and section 69EJG of the Administration Act expressly states that the contravention of a civil penalty provision is not an offence. The applicable penalty for new subsections 35(4) and 37(3) of the Levy Act--being 150 penalty units for individuals and 1250 penalty units for bodies corporate--is reflective of the seriousness of the conduct and the risk contravening behaviour may pose to the Australian Government's ability to meet its international obligations. The proposed penalties are also consistent with other penalties for similar conduct provisions across the Commonwealth statute book, for example section 36 of the Levy Act. Section 69EJD of the Administration Act provides that a court may make a single civil penalty order against a person for multiple contraventions of a civil penalty provision if proceedings for the contraventions are founded on the same facts, or if the contraventions form, or are part of, a series of contraventions of the same or a similar character; however, the penalty must not exceed the sum of the maximum penalties that could be ordered if a separate penalty were ordered for each of the contraventions. There are no criminal consequences associated with civil penalty orders for multiple contraventions (for example, they do not carry the possibility of imprisonment). As such, the civil penalties proposed by new subsections 35(4) and 37(3) of the Levy Act are not sufficiently severe, such that they could be considered to be criminal penalties for the purposes of Australia's human rights obligations. These factors all suggest that the civil penalties proposed by new subsections 35(4) and 37(3) of the Levy Act are civil penalties rather than criminal penalties for the purposes of Australia's human rights obligations. Accordingly, the criminal process rights provided for by Articles 14 and 15 of the ICCPR are not engaged. However, for completeness, and to demonstrate that new subsections 35(4) and 37(3) of the Levy Act are nonetheless compliant with the rights provided for by Articles 14 and 15 of the ICCPR, key provisions of Division 1 of Part 7AB of the Administration Act, which apply to new subsections 35(4) and 37(3) of the Levy Act by virtue of the definition of civil penalty provision in section 4 of the Administration Act, are set out below. Article 14 of the ICCPR requires that, in the determination of criminal charges, everyone shall be entitled to a fair and public hearing by a competent, independent and impartial tribunal established by law. Various other rights are provided for persons charged with criminal offences. Due to the operation of subsection 69EJ(2) of the Administration Act, the time period for the making of an application for a civil penalty order will be within 6 years of the alleged contravention. As the criminal process rights in Article 14 of the ICCPR are not engaged by new subsections 35(4) and 37(3) of the Levy Act, the right to be tried without undue delay provided by paragraph 14(3)(c) of the ICCPR is not engaged. 38

Under section 69EJ of the Administration Act, civil penalty orders can only be granted by a court, which must consider all relevant matters before determining the amount of the penalty. Accordingly, the right to a fair hearing is not limited. Section 69EJJ of the Administration Act clarifies that criminal proceedings may be commenced against a person for conduct that is the same, or substantially the same, as conduct that would constitute a contravention of a civil penalty provision, regardless of whether a civil penalty order has been made against the person in relation to the contravention. This section recognises the importance of criminal proceedings and criminal penalties in dissuading and sanctioning contraventions of the Levy Act, and ensures that criminal remedies are not precluded by earlier civil action. Section 69EJJ of the Administration Act engages the criminal process rights in Article 14 of the ICCPR, but does not limit those rights. Article 14(7) of the ICCPR provides that "no one shall be liable to be tried or punished again for an offence for which he has already been finally convicted or acquitted in accordance with the law and penal procedure of each country". This prohibition on double jeopardy is a fundamental safeguard in the common law of Australia. It means that a person who has been convicted or acquitted of a criminal charge is not to be re-tried for the same or substantially the same offence. As section 69EJJ of the Administration Act permits both civil and criminal proceedings, but not multiple criminal proceedings for the same conduct, Article 14(7) of the ICCPR is not infringed. Further, section 69EJH of the Administration Act provides that a court cannot make a civil penalty order against a person for a contravention of a civil penalty provision if the person has been convicted of an offence constituted by conduct that is the same, or substantially the same, as the conduct constituting the contravention. Section 69EJK of the Administration Act provides that evidence of information given, or evidence of the production of documents, by an individual is not admissible in criminal proceedings against the individual if:  the individual previously gave the information or produced the documents in proceedings for a civil penalty order against the individual for an alleged contravention of a civil penalty provision (whether or not the order was made); and  the conduct alleged to constitute the offence is the same, or substantially the same, as the conduct alleged to constitute the contravention. Section 69EJK of the Administration Act ensures that information or documents produced during civil proceedings are not relied upon to support subsequent criminal proceedings, unless those proceedings are criminal proceedings relating to falsifying evidence in civil proceedings. Accordingly, that section engages, but does not limit, the criminal process rights in Article 14 of the ICCPR. Section 69EJL of the Administration Act provides that if an act or thing is required under a civil penalty provision to be done within a particular period or before a particular time, the obligation to do that act or thing continues until that act or thing is done, even if the period has expired or the time has passed. This section further provides that a person commits a separate contravention of the civil penalty provision in respect of each day during which the contravention occurs, including the day the civil penalty order is made (or any later day). This section is necessary to ensure that failure to comply with an obligation does not excuse a person from meeting that obligation. 39

As discussed above, section 69EJD of the Administration Act provides that a relevant court may make a single civil penalty order against a person for multiple contraventions of a civil penalty provision if proceedings for the contraventions are founded on the same facts, or if the contraventions form, or are part of, a series of contraventions of the same or a similar character; however, the penalty must not exceed the sum of the maximum penalties that could be ordered if a separate penalty were ordered for each of the contraventions. There are no criminal consequences associated with civil penalty orders for multiple contraventions (for example, they do not carry the possibility of imprisonment). Accordingly, the application of section 69EJL of the Administration Act does not engage any human rights. Section 69EJP of the Administration Act provides that, in proceedings for a civil penalty order against a person for a contravention of a civil penalty provision, a person bears an evidential burden where that person wishes to rely on any exception, exemption, excuse, qualification or justification provided by the law creating the civil penalty provision. As section 69EJP of the Administration Act only relates to proceedings for civil penalty orders, not offences, the right to be presumed innocent in Article 14(2) of the ICCPR is not engaged. Sections 69EJC, 69EJE, 69EJF, 69EJI, 69EJM, 69EJN, 69EJO, 69EJQ, 69EJR and 69EJS of the Administration Act relate to:  conduct contravening more than one civil penalty provision;  the ability to hear two or more civil penalty order proceedings together;  the application of the rules and evidence and procedure for civil matters;  the stay of civil proceedings during criminal proceedings;  ancillary contraventions of civil penalty provisions;  mistake of fact;  the relevance of a person's state of mind;  liability of employees, agents or officers of a body corporate, respectively;  liability of executive officers of a body corporate; and  establishing whether an executive officer took reasonable steps to prevent the contravention of a civil penalty provision. Those provisions do not impact upon criminal proceedings and do not engage the criminal process rights in Article 14 of the ICCPR. Article 15 of the ICCPR prohibits the retrospective application of criminal laws. As the amendments to the Levy Act by Part 1 of Schedule 1 to the Bill will only apply in relation to leviable disposals that take place in the 2017-18 financial year, or in a later financial year, Article 15 of the ICCPR is not engaged. There are no additional human rights implications beyond those discussed above. Summary Part 1 of Schedule 1 to the Bill is compatible with the criminal process rights provided for by Articles 14 and 15 of the ICCPR because new subsections 35(4) and 37(3) of the Levy Act do not engage those rights. Right to privacy Article 17 of the ICCPR prohibits arbitrary or unlawful interference with an individual's privacy, family, home or correspondence, and protects a person's honour and reputation from unlawful attacks. The right to privacy can be limited to achieve a legitimate objective where 40

the limitations are lawful and not arbitrary. In order for an interference with the right to privacy to be permissible, the interference must be authorised by law, be for a reason consistent with the ICCPR and be reasonable in the circumstances. The United Nations Human Rights Committee has interpreted the requirement of 'reasonableness' as implying that any interference with privacy must be proportionate to a legitimate end and be necessary in the circumstances. New subsections 35(1), 35(5) and 37(1) of the Levy Act engage the protection against arbitrary or unlawful interference with privacy, as those proposed provisions enable information to be collected, used and disclosed by the APVMA. To the extent that new subsections 35(1), 35(5) and 37(1) of the Levy Act may limit the right to privacy, any limitation is reasonable, necessary and proportionate to the achievement of a legitimate objective. New subsection 35(1) of the Levy Act provides that an interested person in relation to a chemical product who is liable to pay levy in respect of leviable disposals of that product that took place anywhere in Australia at any time during a financial year, must give to the APVMA, before 30 November in the next financial year, a return setting out the total quantity of the chemical product covered by those leviable disposals. The term interested person is currently defined by subsection 3(1) of the Levy Act. New subsection 35(5) of the Levy Act provides that, from the returns given to the APVMA under new subsection 35(1) of the Levy Act in relation to a financial year, the APVMA must give the Secretary, before the end of the next financial year, a statement or statements setting out the total quantities of each active constituent for each chemical product covered by those returns. New subsection 37(1) of the Levy Act provides that the interested person in relation to a chemical product who is liable to pay levy in respect of leviable disposals of the chemical product that took place anywhere in Australia at any time during a financial year must: (a) keep any records relating to those disposals that are reasonably necessary to enable the APVMA to find out whether new section 35 of the Levy Act has been complied with; and (b) retain those records for six years. The Levy Act, the Administration Act and the Code Act form part of the cooperative Commonwealth legislative framework that provides for the evaluation, registration and control of agvet chemical products. The Levy Act pursues the legitimate objective of supporting the broader regulatory framework of that legislative scheme by providing for the assessment and collection of levies in relation to agricultural and veterinary chemical products. New subsections 35(1), 35(5) and 37(1) of the Levy Act will ensure that the APVMA can collect, use and disclose information about agvet chemicals in the marketplace. This information will be used by the Australian Government for policy development and to meet international reporting requirements under international conventions and arrangements. The information will also be important to ensure that the assessment and collection of levies in relation to agricultural and veterinary chemical products is based on accurate data. It is important to note that disclosure will be limited to the Department and will not include personal information. In addition, information will be limited to that information received by 41

the APVMA through the submission of annual returns relating to leviable disposals of chemical products (new subsection 35(5) of the Levy Act). This information will be similar to the information on the financial value of leviable disposals of products that is already provided to the APVMA, and which may already include some personal information e.g. the name and address of the interested person. Therefore, the new annual return reporting requirement will not result in the collection of any new personal information and the APVMA will manage this information in the same manner as it manages personal information now. New subsections 35(1), 35(5) and 37(1) of the Levy Act are necessary to ensure that the Australian Government has sufficient information available to meet its international obligations and can consider the implications for trade in Australian goods if other countries impose restrictions or conditions on agvet chemicals. New subsections 35(1) and 37(1) of the Levy Act will enable the APVMA to collect information about leviable disposals of chemical products, and new subsection 35(5) of the Levy Act will enable the APVMA to disclose that information to the Department. The type of information collected will primarily be commercial information, but compliance with new subsections 35(1) and 37(1) of the Levy Act may incidentally require the provision of personal information. The APVMA may incidentally collect personal information about disposals of agvet chemicals. This is necessary to ensure the APVMA can prepare a statement for the Department (without personal information) in a form that specifies the agvet chemical active constituents disposed of in Australia during a financial year. The APVMA only collects personal information that is reasonably necessary for, or directly related to, one or more of its functions or activities. The APVMA stores all personal information securely and restricts access to a limited number of staff who need access to the information to perform their duties or assist individuals concerned. The APVMA stores information electronically or on hard copy files. The APVMA takes all reasonable steps to ensure that personal information is protected from misuse, loss and interference. When information is no longer required, the APVMA securely destroys it in accordance with the Archives Act 1983 and relevant disposal authorities. The types of information that the APVMA generally collects and holds include personal contact details, financial payments records and mailing and subscription lists. Further, to ensure there is no arbitrary interference with an individual's privacy, the powers and functions in new subsections 35(1), 35(5) and 37(1) of the Levy Act must be exercised in compliance with the Privacy Act. The Privacy Act provides for protections on the collection, storage, use, disclosure or publication of personal information. Items 2 and 3 in Part 1 of Schedule 1 to the Bill, which insert new sections 35 and 37 of the Levy Act, also insert notes at the end of new subsections 35(4) and 37(3) of the Levy Act. Note 1 to new subsections 35(4) and 37(3) of the Levy Act directs the reader to Part 7AA of the Administration Act, which provides for the monitoring and investigation powers of inspectors (as defined by section 4 of the Administration Act). Part 7AA of the Administration Act will apply to new sections 35 and 37 of the Levy Act due to subsection 69EAB(1), sections 69EAH and 69EB and the definition of evidential material in section 4 of the Administration Act. 42

The application of Part 7AA of the Administration Act to new sections 35 and 37 of the Levy Act engages the protection against arbitrary or unlawful interference with privacy. The Levy Act, the Administration Act and the Code Act form part of the cooperative Commonwealth legislative framework that provides for the evaluation, registration and control of agvet chemical products. The Levy Act pursues the legitimate objective of supporting the broader regulatory framework of that legislative scheme by providing for the assessment and collection of levies in relation to agricultural and veterinary chemical products. The Administration Act pursues the legitimate objective of establishing the APVMA as an independent statutory authority of the Commonwealth that is responsible for the regulation and control of agvet chemicals in Australia up to and including the point of retail sale. The Administration Act also provides for the control of the import and export of chemical products, and establishes the coercive and enforcement powers of the APVMA that are applicable to the provisions of the Levy Act and the Administration Act. The entry, monitoring, search, seizure and information-gathering powers of the APVMA in Part 7AA of the Administration Act are provided by law. The monitoring and investigation powers are necessary to enable the APVMA to monitor compliance with the Administration Act and the Levy Act, and to collect evidential material relating to contraventions of those Acts. The monitoring and investigation powers are constrained in various ways, as set out below, ensuring that their use is not arbitrary. Part 7AA of the Administration Act protects against arbitrary interference with privacy, as the monitoring and investigation powers cannot be exercised in relation to premises without the consent of the occupier, or another person who apparently represents the occupier, or through prior judicial authorisation in the form of a warrant (see sections 69EAB and 69EB of the Administration Act). Where entry is based on the consent of the occupier, consent must be informed and voluntary, and the occupier of premises can restrict entry by inspectors to a particular period (see section 69ED of the Administration Act). Additional safeguards are provided through provisions requiring inspectors, and any persons assisting, to leave the premises if the occupier withdraws their consent (see subsection 69ED(5) of the Administration Act). The Administration Act also provides constraints on the issuing of a monitoring or investigation warrant. For example, in the case of an investigation warrant, an issuing officer may issue an investigation warrant only when satisfied, by oath or affirmation, that there are reasonable grounds for suspecting that there is, or may be within 72 hours, evidential material on the premises (see section 69EHA of the Administration Act). An issuing officer must not issue a warrant unless the issuing officer has been provided, either orally or by affidavit, with such further information as they require concerning the grounds on which the issue of the warrant is being sought (see subsection 69EHA(3) of the Administration Act). Such constraints on this power ensure adequate safeguards against arbitrary limitations on the right to privacy in the issuing of warrants. In addition, an inspector cannot enter premises under a warrant unless their identity card is shown to the occupier of the premises (see paragraph 69EDA(1)(b) of the Administration Act). If entry is authorised by warrant, the inspector must also provide a copy of the warrant to the occupier of the premises (section 69EDC of the Administration Act). This provides for the transparent utilisation of the powers and mitigates arbitrariness and risk of abuse. 43

Further, the power to seize evidence of a kind not specified in a warrant may only be exercised in the limited circumstances set out in sections 69EAE and 69EBC of the Administration Act. These constraints on the exercise of monitoring and investigations powers also limit their susceptibility to arbitrary use or abuse and ensure that their use is reasonable and proportionate in the circumstances. Accordingly, the monitoring and investigating powers in Part 7AA of the Administration Act are necessary, proportionate and reasonable in the pursuance of the legitimate objectives of the Administration Act and the Levy Act. Summary Part 1 of Schedule 1 to the Bill is compatible with human rights because, to the extent that the application of Part 7AA of the Administration Act to new sections 35 and 37 of the Levy Act may limit the right to privacy in Article 17 of the ICCPR, that limitation is reasonable, necessary and proportionate to the achievement of a legitimate outcome. Right to security of person and right to life Items 2 and 3 in Part 1 of Schedule 1 to the Bill, which insert new sections 35 and 37 of the Levy Act, also insert notes at the end of new subsections 35(4) and 37(3) of the Levy Act. Note 1 to new subsections 35(4) and 37(3) of the Levy Act directs the reader to Part 7AA of the Administration Act, which provides for the monitoring and investigation powers of inspectors (as defined by section 4 of the Administration Act). Part 7AA of the Administration Act apply to new sections 35 and 37 of the Levy Act due to subsection 69EAB(1), sections 69EAH and 69EB and the definition of evidential material in section 4 of the Administration Act. Under sections 69EAG and 69EBE of the Administration Act, an inspector, or a person assisting an inspector, executing a monitoring or investigation warrant may use such force against things as is necessary and reasonable in the circumstances. Sections 69EAG and 69EBE of the Administration Act ensure that the effect of a monitoring and investigation warrant is not frustrated by an inability to open locked doors, cabinets, drawers, containers and other similar objects that the inspector reasonably suspects contains things or information that would provide evidence of non-compliance with the provisions of the Administration Act or the Levy Act. As this power does not extend to the use of force against persons, it does not engage the right to security of person in Article 9 of the ICCPR or the right to life in Article 6 of the ICCPR. Further, the power can only be exercised under a monitoring or investigation warrant, which must be issued by a judicial officer, and the power may only be used as is necessary and reasonable in the circumstances. Summary Part 1 of Schedule 1 to the Bill is compatible with the right to security of person in Article 9 of the ICCPR and the right to life in Article 6 of the ICCPR because the application of Part 7AA of the Administration Act to new sections 35 and 37 of the Levy Act does not engage those rights. 44

Criminal process rights (monitoring and investigation powers) Items 2 and 3, which insert new sections 35 and 37 of the Levy Act, also insert notes at the end of new subsections 35(4) and 37(3) of the Levy Act. Note 1 to new subsections 35(4) and 37(3) of the Levy Act directs the reader to Part 7AA of the Administration Act, which provides for the monitoring and investigation powers of inspectors (as defined by section 4 of the Administration Act). Part 7AA of the Administration Act will apply to new sections 35 and 37 of the Levy Act due to subsection 69EAB(1), sections 69EAH and 69EB and the definition of evidential material in section 4 of the Administration Act. The application of Part 7AA of the Administration Act to new sections 35 and 37 of the Levy Act engages the criminal process rights contained in Article 14 of the ICCPR, as a number of offences in Part 7AA of the Administration Act apply to the exercise of monitoring or investigation powers in relation to new sections 35 and 37 of the Levy Act. These provisions have been set out below. Sections 69EAH and 69EC of the Administration Act provide questioning powers to inspectors. Under subsection 69EAH(3) of the Administration Act, where entry is authorised by a monitoring warrant, the inspector may require any person on the premises to answer questions or produce documents relating to the operation of the Administration Act or the Levy Act or information provided under those Acts. Under subsection 69EAH(4) of the Administration Act, if the person fails to do so, they commit an offence subject to a criminal pecuniary penalty of 50 penalty units. Similarly, under subsection 69EC(3) of the Administration Act an inspector who enters premises under an investigation warrant may require persons on the premises to answer questions or produce documents relating to evidential material of the kind specified in the warrant. Under subsection 69EC(4) of the Administration Act, if the person fails to do so, they commit an offence subject to a criminal pecuniary penalty of 50 penalty units. Sections 69EAC and 69EBA of the Administration Act provide for monitoring and investigation powers. Subsection 69EAC(2) of the Administration Act provides that a person must comply with a direction that has been given to that person under paragraphs 69EAC(1)(i) or (1)(j) of that Act. Under subsection 69EAC(3) of the Administration Act, if the person fails to do so, they commit an offence of strict liability subject to a criminal pecuniary penalty of 30 penalty units. Subsection 69EBA(2) of the Administration Act provides that a person must comply with a direction that has been given to that person under paragraphs 69EBA(1)(i) or (1)(j) of that Act. Under subsection 69EBA(3) of the Administration Act, if the person fails to do so, they commit an offence of strict liability subject to a criminal pecuniary penalty of 30 penalty units. Section 69EBC of the Administration Act enables an inspector to seize evidence of related offences and related civil penalty provisions where an inspector has entered premises under an investigation warrant. Subsection 69EBC(4) of the Administration Act provides that a person must comply with a direction that has been given to that person under subsection 69EBC(3) of that Act. Under subsection 69EBC(3) of the Administration Act, if the person fails to do so, they commit an offence of strict liability subject to a criminal pecuniary penalty of 30 penalty units. Subsection 69EFA(1) of the Administration Act provides that an occupier of premises to which a monitoring or investigation warrant relates, or another person who apparently represents the occupier, must provide the inspector executing the warrant, or any person 45

assisting, with all reasonable facilities and assistance for the effective exercise of their powers. Under subsection 69EFA(2) of the Administration Act, if the person fails to do so, they commit an offence subject to a criminal pecuniary penalty of 30 penalty units. Section 69EHD of the Administration Act creates an offence, subject to imprisonment for two years, where an inspector inappropriately deals with a warrant that was issued by a telephone, fax machine or other electronic means. These offence provisions do not limit a person's access to a fair trial or limit the other criminal process rights in any way. Section 69EQ of the Administration Act makes it clear that the privilege against self-incrimination has not been abrogated by the monitoring and investigation powers provisions, including the offence provisions. These protections guarantee the criminal process rights protected in Articles 14(3)(d) and (3)(g) of the ICCPR. The usual guarantees and criminal process rights apply to these offences and are not abrogated by the application of Part 7AA of the Administration Act to new sections 35 and 37 of the Levy Act. Summary Part 1 of Schedule 1 to the Bill is compatible with the criminal process rights provided for by Article 14 of the ICCPR because, to the extent that the application of Part 7AA of the Administration Act to new sections 35 and 37 of the Levy Act engages those rights, it does not limit those rights. Infringement notices and Article 14 Items 2 and 3 in Part 1 of Schedule 1 to the Bill, which insert new sections 35 and 37 of the Levy Act, also insert notes at the end of new subsections 35(4) and 37(3) of the Levy Act. Note 3 to new subsections 35(4) and 37(3) of the Levy Act direct the reader to Divisions 2, 3 and 6 of Part 7AB of the Administration Act, which provide for matters in relation to infringement notices, enforceable undertakings and formal warnings that may be used in relation to a contravention of new subsection 35(1) or 37(1) of the Levy Act. Division 2 of Part 7AB of the Administration Act enables an inspector (as defined in section 4 of the Administration Act) to issue infringement notices where they believe, on reasonable grounds, that a person has contravened a prescribed civil penalty provision. Section 4 of the Administration Act defines prescribed civil penalty provision to mean a civil penalty provision that is prescribed by the Administration Regulations. Section 3A.01 of the Administration Regulations states that, for the definition of prescribed civil penalty provision in section 4 of the Administration Act, each civil penalty provision mentioned in Schedule 5 to the Administration Regulations is prescribed. New sections 35 and 37 of the Levy Act are not mentioned in Schedule 5 to the Administration Regulations. Accordingly, Division 2 of Part 7AB of the Administration Act will not apply to new sections 35 and 37 of the Levy Act unless Schedule 5 to the Administration Regulations is amended to list new sections 35 and 37 of the Levy Act. It is intended that Schedule 5 to the Administration Regulations will be amended at a later date to list new sections 35 and 37 of the Levy Act. An infringement notice issued under Division 2 of Part 7AB of the Administration Act is a notice of a pecuniary penalty imposed on a person. It sets out the particulars of an alleged contravention of a law. An infringement notice gives the person to whom the notice is issued 46

the option of paying the penalty set out in the notice, or electing to have the matter dealt with by a court. As Division 2 of Part 7AB of the Administration Act only applies to civil penalty provisions, the criminal process rights in Article 14 of the ICCPR are not engaged. There are no criminal consequences associated with infringement notices for civil penalty provisions. For example, they do not carry the possibility of imprisonment if the person does not pay the penalty or attend court. Paragraph 69EKA(1)(k) of the Administration Act provides that an infringement notice is required to state that the person may choose not to pay the penalty and notify them that, if they do so, proceedings seeking a civil penalty order may be brought against them in a court. Accordingly, the person must always be advised of the consequences of not paying the penalty, and of their right to have the matter dealt with by a court. As the person may elect to have the matter heard by a court, rather than pay the penalty, the right to a fair and public hearing for by Article 14(2) of the ICCPR is not limited. Accordingly, the application of Division 2 of Part 7AB of the Administration Act to new sections 35 and 37 of the Levy Act is consistent with human rights. Summary Part 1 of Schedule 1 to the Bill is compatible with the criminal process rights provided for by Article 14 of the ICCPR because the application of Division 2 of Part 7AB of the Administration Act to new sections 35 and 37 of the Levy Act does not engage those rights. Enforceable undertakings and Article 14 Items 2 and 3 in Part 1 of Schedule 1 to the Bill, which insert new sections 35 and 37 of the Levy Act, also insert notes at the end of new subsections 35(4) and 37(3) of the Levy Act. Note 3 to new subsections 35(4) and 37(3) of the Levy Act directs the reader to Divisions 2, 3 and 6 of Part 7AB of the Administration Act, which provide for matters in relation to infringement notices, enforceable undertakings and formal warnings that may be used in relation to a contravention of new subsection 35(1) or 37(1) of the Levy Act. Division 3 of Part 7AB of the Administration Act enables the APVMA to accept and enforce undertakings relating to the provisions of the Administration Act or the Levy Act (see sections 69EL and 69ELA of the Administration Act). Under section 69ELA of the Administration Act, if the APVMA is satisfied that a person has breached an undertaking, the APVMA may apply to a court of competent jurisdiction for an order relating to the undertaking. Applying the enforceable undertakings provisions of the Administration Act to new subsections 35(3) and (4) and 37(2) and (3) of the Levy Act engages the right to a fair and public hearing, and other criminal process rights and minimum guarantees, in Article 14 of the ICCPR. Article 14(1) of the ICCPR provides that everyone shall be entitled to a fair and public hearing by a competent, independent and impartial tribunal established by law. Under Division 3 of Part 7AB of the Administration Act, an order enforcing an undertaking can only be made by a court. Accordingly, the right to a fair and public hearing is not limited. Further, the application of Division 3 of Part 7AB of the Administration Act to new sections 35 and 37 of the Levy Act does not limit the minimum guarantees and other criminal process rights in Article 14 of the ICCPR. The minimum guarantees and process rights will apply to criminal proceedings. 47

Summary Part 1 of Schedule 1 to the Bill is compatible with the criminal process rights provided for by Article 14 of the ICCPR because, to the extent that the application of Division 3 of Part 7AB of the Administration Act to new sections 35 and 37 of the Levy Act engages those rights, it does not limit those rights. Part 2 of Schedule 1--Preliminary assessments Part 2 of Schedule 1 to the Bill 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 as it does not engage any human rights. Part 3 of Schedule 1--Variation of relevant particulars and conditions Right to an effective remedy Article 2(3) of the ICCPR ensures that any person whose rights or freedoms are adversely affected by a person acting in an official capacity shall have an effective remedy, and that such a person shall have his or her rights determined by a competent judicial, administrative or legislative authority. Part 3 of Schedule 1 to the Bill positively engages the right to an effective remedy in Article 2(3) of the ICCPR, as it provides a mechanism by which affected persons are able to seek a review of certain decisions. Items 16 and 17 in Part 3 of Schedule 1 to the Bill seek to amend section 8S of the Agvet Code to provide the APVMA with the flexibility to vary relevant particulars or conditions of an approval of an active constituent, a registration of a chemical product, or an approval of a label for containers for a chemical product, in a way other than as set out in the original application for variation. The amendments also seek to provide an applicant with the opportunity to provide written submissions on such a variation. Subsection 8S(1) of the Agvet Code currently provides that the APVMA must give an applicant written notice of what it proposes to do before it: (a) refuses an application, other than on preliminary assessment; or (b) approves or registers an active constituent, chemical product or label with instructions or relevant particulars other than those set out in the application. New paragraph 8S(1)(c) of the Agvet Code provides that the APVMA must give an applicant written notice of what it proposes to do before it varies, under section 29 of the Agvet Code, relevant particulars or conditions in a way other than set out in the original application. Subsection 29(1) of the Agvet Code currently provides that the APVMA must vary the relevant particulars or conditions of an approval of an active constituent, a registration of a chemical product, or an approval of a label for containers for a chemical product if it is satisfied: (a) that the application meets the application requirements; and (b) for an active constituent--that, if those particulars or conditions were varied in accordance with the application, the constituent would meet the safety criteria; and 48

(c) for a chemical product--that, if those particulars or conditions were varied in accordance with the application, the product would: (i) meet the safety criteria, the trade criteria and the efficacy criteria; or (ii) comply with the established standard for the product; and (d) for a label for a chemical product--that, if those particulars or conditions were varied in accordance with the application, the label would: (i) meet the labelling criteria; or (ii) comply with the established standard for the product. New paragraph 8S(2)(b) of the Agvet Code provides that the written notice issued under subsection 8S(1) of the Agvet Code must, for a notice issued under new paragraph 8S(1)(c) of the Agvet Code, set out the proposed variation. Subsection 8S(2) of the Agvet Code currently provides that the written notice issued under subsection 8S(1) of the Agvet Code must contain a number of matters, which are currently set out by paragraphs 8S(2)(a), (c), (d) and (e) of the Agvet Code to be: (a) for a notice issued under subsection 8S(1)(b)--the proposed instructions and relevant particulars; and (c) a draft statement of reasons for the proposed course of action; and (d) information on which the reasons are based (including information not given to the APVMA by the applicant); and (e) an invitation for written submissions from the applicant within 28 days, or within such further period as is specified in the notice. The proposed amendments to section 8S of the Agvet Code will ensure that the APVMA is able to grant part of an original application for variation, where that partial variation meets the criteria set out in subsection 29(1) of the Agvet Code. For completeness, section 8D of the Agvet Code currently provides that, at any time after an application is made and before it is determined, an applicant may withdraw that application by giving the APVMA written notice of the withdrawal signed by the applicant. Accordingly, an applicant will also be able to withdraw their original variation application after making written submissions to the APVMA in relation to the proposed variation that is in a way other than set out in the original application. In addition to the proposed amendments to section 8S of the Agvet Code, an applicant will also have access to review rights. Section 166 of the Agvet Code currently provides for the internal review of decisions by the APVMA under various provisions of the Agvet Code, including a decision under subsection 29(2) of the Agvet Code to refuse to vary the relevant particulars or conditions of an approval of an active constituent, a registration of a chemical product, or an approval of a label for containers for a chemical product. Further, due to new paragraph 167(1)(ca) of the Agvet Code and the amendments proposed to subsection 29(1) of the Agvet Code by item 18 in Part 3 of Schedule 1 to the Bill, an affected applicant will have the ability to apply to the APVMA and the Administrative Appeals Tribunal for review of a decision made by the APVMA under subsection 29(1) of the Agvet Code to vary relevant particulars or conditions in a way other than as set out in the original application for variation. 49

New paragraph 167(1)(ca) of the Agvet Code provides that an application may be made to the APVMA and the Administrative Appeals Tribunal for review of a decision by the APVMA under subsection 29(1) of the Agvet Code to vary relevant particulars or conditions in a way other than as set out in the original application for variation. Item 18 in Part 3 of Schedule 1 to the Bill omits the references to "in accordance with the application" in paragraphs 29(1)(b), (c) and (d) of the Agvet Code, and substitutes those references with references to "in a particular way (which may not be the same way as set out in the application)". It is appropriate that new paragraph 167(1)(ca) of the Agvet Code will provide a pathway for applicants to seek merits review of a decision by the APVMA to vary relevant particulars or conditions in a way other than as set out in the original application for variation, as an applicant could be affected by such a decision. Summary Part 3 of Schedule 1 to the Bill is compatible with the right to an effective remedy provided for by Article 2(3) of the ICCPR because the amendments proposed by that Part promote and protect that right by providing a mechanism by which affected persons are able to seek review of administrative decisions. Part 4 of Schedule 1--Variation of label approval while approval suspended Part 4 of Schedule 1 to the Bill 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 as it does not engage any human rights. Part 5 of Schedule 1--False and misleading information Civil penalties and Articles 14 and 15 Prescribing conduct that is subject to a civil penalty could engage criminal process rights if the imposition of a civil penalty is classified as 'criminal' under international human rights law. Guidance Note 2: Offence provisions, civil penalties and human rights (December 2014), which is published by the Parliamentary Joint Committee on Human Rights, states that civil penalty provisions may engage criminal process rights under Articles 14 and 15 of the ICCPR, regardless of the distinction between criminal and civil penalties in domestic law. When a provision imposes a civil penalty, an assessment is required as to whether it amounts to a 'criminal' penalty for the purposes of the ICCPR. Agricultural and Veterinary Chemicals (Administration) Act 1992 New subsection 69ER(5) of the Administration Act provides that new subsections 69ER(3) and (4) of that Act are civil penalty provisions. New subsection 69ER(3) of the Administration Act complements existing subsection 69ER(1) of that Act by creating a civil penalty provision that provides that a person must not, for the purposes of, or in connection with, the making of a decision by the APVMA as to whether it should give a consent under section 69B of the Administration Act: (a) give information (whether orally or in writing) that the person knows to be false or misleading in a material particular; or 50

(b) produce a document that the person knows to be false or misleading in a material particular without: (i) indicating to the person to whom the document is produced that it is false or misleading and the respect in which it is false or misleading; and (ii) providing correct information to that person if the person producing the document is in possession of, or can reasonably acquire, the correct information. Subsection 69ER(1) of the Administration Act provides that a person commits an offence (subject to a criminal pecuniary penalty of 300 penalty units) if, for the purposes of, or in connection with, the making of a decision by the APVMA as to whether it should give consent under section 69B of the Administration Act, that person: (a) gives information (whether orally or in writing) that the person knows to be false or misleading in a material particular; or (b) produces a document that the person knows to be false or misleading in a material particular without: (i) indicating to the person to whom the document is produced that it is false or misleading and the respect in which it is false or misleading; and (ii) providing correct information to that person if the person producing the document is in possession of, or can reasonably acquire, the correct information. New subsection 69ER(4) of the Administration Act complements existing subsection 69ER(2) of that Act by creating a civil penalty provision that provides that a person must not, in compliance or purported compliance with a requirement made by an inspector (as defined by section 4 of the Administration Act) under Part 7A, Part 7AA or Part 7AB of the Administration Act, or for the purposes of, or in connection with, any provision of Part 7A (excluding section 69B), Part 7AA or Part 7AB of that Act: (a) give information (whether orally or in writing) that the person knows to be false or misleading in a material particular; or (b) produce a document that the person knows to be false or misleading in a material particular without: (i) indicating to the person to whom the document is produced that it is false or misleading and the respect in which it is false or misleading; and (ii) providing correct information to that person if the person producing the document is in possession of, or can reasonably acquire, the correct information. Subsection 69ER(2) of the Administration Act provides that a person commits an offence (subject to a criminal pecuniary penalty of 60 penalty units) if, in compliance or purported compliance with a requirement made by an inspector (as defined by section 4 of the Administration Act) under Part 7A, Part 7AA or Part 7AB of the Administration Act, or for the purposes of, or in connection with, any provision of Part 7A (excluding section 69B), Part 7AA or Part 7AB of that Act, that person: (a) gives information (whether orally or in writing) that the person knows to be false or misleading in a material particular; or (b) produces a document that the person knows to be false or misleading in a material particular without: (i) indicating to the person to whom the document is produced that it is false or misleading and the respect in which it is false or misleading; and (ii) providing correct information to that person if the person producing the document is in possession of, or can reasonably acquire, the correct information. 51

Determining whether penalties could be considered to be criminal under international human rights law requires consideration of the classification of the penalty provisions under Australian domestic law, the nature and purpose of the penalties, and the severity of the penalties. Item 27 in Part 5 of Schedule 1 to the Bill, which seeks to insert new subsections 69ER(3) to (5) of the Administration Act, also inserts a note at the end of new subsection 69ER(5) of that Act to direct the reader to Division 1 of Part 7AB of the Administration Act. Division 1 of Part 7AB of the Administration Act creates a framework for the use of civil pecuniary penalties to enforce the civil penalty provisions of the Administration Act and the Levy Act (see the definition of civil penalty provision in section 4 of the Administration Act). Subsection 69EJA(1) of the Administration Act provides that the pecuniary penalty for a contravention of a civil penalty provision by a body corporate must not exceed five times the amount of the maximum monetary penalty that could be imposed by a court if the body corporate were convicted of an offence constituted by conduct that is the same as the conduct constituting the contravention. Subsection 69EJA(2) of the Administration Act provides that the pecuniary penalty for a contravention of a civil penalty provision by an individual must not exceed three times the amount of the maximum monetary penalty that could be imposed by a court if the person were convicted of an offence constituted by conduct that is the same as the conduct constituting the contravention. It is important to note that subsection 69EJA(1) of the Administration Act refers to the maximum monetary penalty that could be imposed by a court if a body corporate were convicted of an offence constituted by conduct that is the same as the conduct constituting the contravention. Subsection 4B(3) of the Crimes Act states that, where a body corporate is convicted of an offence against a law of the Commonwealth, a court may, if the contrary intention does not appear and the court thinks fit, impose a pecuniary penalty not exceeding an amount equal to five times the amount of the maximum pecuniary penalty that could be imposed by the court on a natural personal convicted of the same offence. The applicable criminal pecuniary penalty for an individual for a contravention of current subsection 69ER(1) of the Administration Act is 300 penalty units. The applicable criminal pecuniary penalty for an individual for a contravention of current subsection 69ER(2) of the Administration Act is 60 penalty units. Accordingly, as there is no contrary intention in the Administration Act, the corresponding criminal pecuniary penalty for a body corporate for a contravention of current subsection 69ER(1) of the Administration Act will be 1,500 penalty units, and the corresponding criminal pecuniary penalty for a body corporate for a contravention of current subsection 69ER(2) of the Administration Act will be 300 penalty units. By virtue of section 69EJA of the Administration Act, and the matters prescribed by current subsection 69ER(1) of that Act (including the application of subsection 4B(3) of the Crimes Act to that subsection), the civil pecuniary penalty for new subsection 69ER(3) of the Administration Act will be 900 penalty units for individuals and 7,500 penalty units for bodies corporate. By virtue of section 69EJA of the Administration Act, and the matters prescribed by current subsection 69ER(2) of that Act (including the application of subsection 4B(3) to that subsection), the civil pecuniary penalty for new subsection 69ER(4) 52

of the Administration Act will be 180 penalty units for individuals and 1,500 penalty units for bodies corporate. The penalty provisions proposed to be created by new subsections 69ER(3) and (4) of the Administration Act are expressly classified as civil penalty provisions by new subsection 69ER(5) of that Act. That is, new subsections 69ER(3) and (4) of the Administration Act seek to create a solely pecuniary penalty in the form of a debt payable to the Commonwealth (see section 69EJB of the Administration Act). The purpose of new subsections 69ER(3) and (4) of the Administration Act is to encourage compliance with the prohibition on providing false and misleading information or documents to the APVMA. New subsections 69ER(3) and (4) of the Administration Act do not seek to impose criminal liability and do not lead to the creation of a criminal record. The proposed penalties will only apply to those persons who are seeking a decision by the APVMA under section 69B of the Administration Act, or who are subject to a requirement made by an inspector under Part 7A, Part 7AA or Part 7AB of the Administration Act, or for the purposes of, or in connection with, any provision of Part 7A (other than section 69B), Part 7AA or Part 7AB of that Act. That is, the penalty does not apply to the public in general. Further, the imposition of the civil pecuniary penalties in new subsections 69ER(3) and (4) of the Administration Act are not dependent on a finding of guilt, and section 69EJG of the Administration Act expressly states that the contravention of a civil penalty provision is not an offence. The applicable penalty for new subsection 69ER(3) of the Administration Act--being 900 penalty units for individuals and 7,500 penalty units for bodies corporate--is reflective of the seriousness of the conduct and the risk contravening behaviour may pose to human health and safety, the environment and trade if agvet chemicals are used inappropriately on the basis of false or misleading information or documents. The applicable penalty for new subsection 69ER(4) of the Administration Act--being 180 penalty units for individuals and 1,500 penalty units for bodies corporate--is reflective of the seriousness of the conduct and the risk contravening behaviour may pose to human health and safety, the environment and trade if agvet chemicals are used inappropriately on the basis of false or misleading information or documents. Further, the penalties proposed by new subsections 69ER(3) and (4) of the Administration Act are significantly less than the civil pecuniary penalties prescribed by section 31AAA of the Therapeutic Goods Act for similar conduct in relation to the provision of false or misleading information or documents, which are 5,000 penalty units for individuals and 50,000 penalty units for bodies corporate. This reflects the lower amounts for the current offences in relation to the provision of false or misleading information or documents in the Administration Act. Section 69EJD of the Administration Act provides that a court may make a single civil penalty order against a person for multiple contraventions of a civil penalty provision if proceedings for the contraventions are founded on the same facts, or if the contraventions form, or are part of, a series of contraventions of the same or a similar character; however, the penalty must not exceed the sum of the maximum penalties that could be ordered if a separate penalty were ordered for each of the contraventions. There are no criminal consequences associated with civil penalty orders for multiple contraventions (for example, they do not 53

carry the possibility of imprisonment). As such, the civil penalties proposed by new subsections 69ER(3) and (4) of the Administration Act are not sufficiently severe such that they could be considered to be criminal penalties for the purposes of Australia's human rights obligations. These factors all suggest that the civil penalties proposed by new subsections 69ER(3) and (4) of the Administration Act are civil penalties rather than criminal penalties for the purposes of Australia's human rights obligations. Accordingly, the criminal process rights provided for by Articles 14 and 15 of the ICCPR are not engaged. However, for completeness, and to demonstrate that new subsections 69ER(3) and (4) of the Administration Act are nonetheless compliant with the rights provided for by Articles 14 and 15 of the ICCPR, key provisions of Division 1 of Part 7AB of the Administration Act are set out below. Article 14 of the ICCPR requires that, in the determination of criminal charges, everyone shall be entitled to a fair and public hearing by a competent, independent and impartial tribunal established by law. Various other rights are provided for persons charged with criminal offences. Due to the operation of subsection 69EJ(2) of the Administration Act, the time period for the making of an application for a civil penalty order will be within 6 years of the alleged contravention. As the criminal process rights in Article 14 of the ICCPR are not engaged by new subsections 69ER(3) and (4) of the Administration Act, the right to be tried without undue delay provided by paragraph 14(3)(c) of the ICCPR is not engaged. Under section 69EJ of the Administration Act, civil penalty orders can only be granted by a court, which must consider all relevant matters before determining the amount of the penalty. Accordingly, the right to a fair hearing is not limited. Section 69EJJ of the Administration Act clarifies that criminal proceedings may be commenced against a person for conduct that is the same, or substantially the same, as conduct that would constitute a contravention of a civil penalty provision, regardless of whether a civil penalty order has been made against the person in relation to the contravention. This section recognises the importance of criminal proceedings and criminal penalties in dissuading and sanctioning contraventions of the Administration Act, and ensures that criminal remedies are not precluded by earlier civil action. Section 69EJJ of the Administration Act engages the criminal process rights in Article 14 of the ICCPR, but does not limit those rights. Article 14(7) of the ICCPR provides that "no one shall be liable to be tried or punished again for an offence for which he has already been finally convicted or acquitted in accordance with the law and penal procedure of each country". This prohibition on double jeopardy is a fundamental safeguard in the common law of Australia. It means that a person who has been convicted or acquitted of a criminal charge is not to be re-tried for the same or substantially the same offence. As section 69EJJ of the Administration Act permits both civil and criminal proceedings, but not multiple criminal proceedings for the same conduct, Article 14(7) of the ICCPR is not infringed. Further, section 69EJH of the Administration Act provides that a court cannot make a civil penalty order against a person for a contravention of a civil penalty provision if the person has been convicted of an offence constituted by conduct that is the same, or substantially the same, as the conduct constituting the contravention. 54

Section 69EJK of the Administration Act provides that evidence of information given, or evidence of the production of documents, by an individual is not admissible in criminal proceedings against the individual if:  the individual previously gave the information or produced the documents in proceedings for a civil penalty order against the individual for an alleged contravention of a civil penalty provision (whether or not the order was made); and  the conduct alleged to constitute the offence is the same, or substantially the same, as the conduct alleged to constitute the contravention. Section 69EJK of the Administration Act ensures that information or documents produced during civil proceedings are not relied upon to support subsequent criminal proceedings, unless those proceedings are criminal proceedings relating to falsifying evidence in civil proceedings. Accordingly, that section engages, but does not limit, the criminal process rights in Article 14 of the ICCPR. Section 69EJL of the Administration Act provides that if an act or thing is required under a civil penalty provision to be done within a particular period or before a particular time, the obligation to do that act or thing continues until that act or thing is done, even if the period has expired or the time has passed. This section further provides that a person commits a separate contravention of the civil penalty provision in respect of each day during which the contravention occurs, including the day the civil penalty order is made (or any later day). This section is necessary to ensure that failure to comply with an obligation does not excuse a person from meeting that obligation. As discussed above, section 69EJD of the Administration Act provides that a relevant court may make a single civil penalty order against a person for multiple contraventions of a civil penalty provision if proceedings for the contraventions are founded on the same facts, or if the contraventions form, or are part of, a series of contraventions of the same or a similar character; however, the penalty must not exceed the sum of the maximum penalties that could be ordered if a separate penalty were ordered for each of the contraventions. There are no criminal consequences associated with civil penalty orders for multiple contraventions (for example, they do not carry the possibility of imprisonment). Accordingly, the application of section 69EJL of the Administration Act does not engage any human rights. Section 69EJP of the Administration Act provides that, in proceedings for a civil penalty order against a person for a contravention of a civil penalty provision, a person bears an evidential burden where that person wishes to rely on any exception, exemption, excuse, qualification or justification provided by the law creating the civil penalty provision. As section 69EJP of the Administration Act only relates to proceedings for civil penalty orders, not offences, the right to be presumed innocent in Article 14(2) of the ICCPR is not engaged. Sections 69EJC, 69EJE, 69EJF, 69EJI, 69EJM, 69EJN, 69EJO, 69EJQ, 69EJR and 69EJS of the Administration Act relate to:  conduct contravening more than one civil penalty provision;  the ability to hear two or more civil penalty order proceedings together;  the application of the rules and evidence and procedure for civil matters;  the stay of civil proceedings during criminal proceedings;  ancillary contraventions of civil penalty provisions;  mistake of fact;  the relevance of a person's state of mind; 55

 liability of employees, agents or officers of a body corporate, respectively;  liability of executive officers of a body corporate; and  establishing whether an executive officer took reasonable steps to prevent the contravention of a civil penalty provision. Those provisions do not impact upon criminal proceedings and do not engage the criminal process rights in Article 14 of the ICCPR. Article 15 of the ICCPR prohibits the retrospective application of criminal laws. As the amendments to the Administration Act in Part 5 of Schedule 1 to the Bill will only apply in relation to information given, or a document produced, on or after the commencement of Part 5--being the end of the period of three months beginning on the day after the Bill receives the Royal Assent--Article 15 of the ICCPR is not engaged. There are no additional human rights implications beyond those discussed above. Agricultural and Veterinary Chemicals Code Act 1994 New subsection 146(5) of the Agvet Code provides that new subsections 146(3) and (4) of the Agvet Code are civil penalty provisions. New subsection 146(3) of the Agvet Code complements existing subsection 146(1) of the Agvet Code by creating a civil penalty provision that provides that a person must not, for the purposes of, or in connection with, the consideration by the APVMA, in the course of the performance of any of its functions or the exercise of any of its powers under the Agvet Code, of any matters referred to in sections 5A, 5B, 5C or 5D or subsection 123(1) of the Agvet Code: (a) give information (whether orally or in writing) that the person knows to be false or misleading in a material particular; or (b) produce a document that the person knows to be false or misleading in a material particular without: (i) indicating to the person to whom the document is produced that it is false or misleading and the respect in which it is false or misleading; and (ii) providing correct information to that person if the person producing the document is in possession of, or can reasonably acquire, the correct information. Subsection 146(1) of the Agvet Code provides that a person commits an offence (subject to a criminal pecuniary penalty of 300 penalty units) if, for the purposes of, or in connection with, the consideration by the APVMA, in the course of the performance of any of its functions or the exercise of any of its powers under the Agvet Code, of any matters referred to in section 5A (safety criteria), 5B (trade criteria), 5C (efficacy criteria) or 5D (labelling criteria) or subsection 123(1) (manufacturing licence applications) of the Agvet Code, that person: (a) gives information (whether orally or in writing) that the person knows to be false or misleading in a material particular; or (b) produces a document that the person knows to be false or misleading in a material particular without: (i) indicating to the person to whom the document is produced that it is false or misleading and the respect in which it is false or misleading; and (ii) providing correct information to that person if the person producing the document is in possession of, or can reasonably acquire, the correct information. 56

New subsection 146(4) of the Agvet Code complements existing subsection 146(2) of the Agvet Code by creating a civil penalty provision that provides that a person must not, for the purposes of, or in connection with, the consideration by the APVMA, in the course of the performance of any of its functions or the exercise of any of its powers under the Agvet Code, of any matters other than matters referred to in new subsection 146(3) of the Agvet Code: (a) give information (whether orally or in writing) that the person knows to be false or misleading in a material particular; or (b) produce a document that the person knows to be false or misleading in a material particular without: (i) indicating to the person to whom the document is produced that it is false or misleading and the respect in which it is false or misleading; and (ii) providing correct information to that person if the person producing the document is in possession of, or can reasonably acquire, the correct information. Subsection 146(2) of the Agvet Code provides that a person commits an offence (subject to a criminal pecuniary penalty of 60 penalty units) if, for the purposes of, or in connection with, the consideration by the APVMA, in the course of the performance of any of its functions or the exercise of any of its powers under the Agvet Code, of any matters other than matters referred to in subsection 146(1) of that Code, that person: (a) gives information (whether orally or in writing) that the person knows to be false or misleading in a material particular; or (b) produces a document that the person knows to be false or misleading in a material particular without: (i) indicating to the person to whom the document is produced that it is false or misleading and the respect in which it is false or misleading; and (ii) providing correct information to that person if the person producing the document is in possession of, or can reasonably acquire, the correct information. Determining whether penalties could be considered to be criminal under international human rights law requires consideration of the classification of the penalty provisions under Australian domestic law, the nature and purpose of the penalties, and the severity of the penalties. Item 29 in Part 5 of Schedule 1 to the Bill, which seeks to insert new subsections 146(3) to (5) of the Agvet Code, also inserts a note at the end of new subsection 146(5) of the Agvet Code to direct the reader to Division 2 of Part 9A of the Agvet Code. Division 2 of Part 9A of the Agvet Code creates a framework for the use of civil penalties to enforce civil penalty provisions of the Agvet Code. Subsection 145AA(1) of the Agvet Code provides that the pecuniary penalty for a contravention of a civil penalty provision by a body corporate must not exceed five times the amount of the maximum monetary penalty that could be imposed by a court if the body corporate were convicted of an offence constituted by conduct that is the same as the conduct constituting the contravention. Subsection 145AA(2) of the Agvet Code provides that the pecuniary penalty for a contravention of a civil penalty provision by an individual must not exceed three times the amount of the maximum monetary penalty that could be imposed by a court if the person were convicted of an offence constituted by conduct that is the same as the conduct constituting the contravention. 57

It is important to note that subsection 145AA(1) of the Agvet Code refers to the maximum monetary penalty that could be imposed by a court if a body corporate were convicted of an offence constituted by conduct that is the same as the conduct constituting the contravention. Subsection 170(5) of the Agvet Code states that, where a body corporate is convicted of an offence against the Agvet Code, a court may, if the court thinks fit, impose a monetary penalty not greater than five times the amount of the maximum monetary penalty that could be imposed by the court on an individual convicted of the same offence. The applicable criminal pecuniary penalty for an individual for a contravention of current subsection 146(1) of the Agvet Code is 300 penalty units. The applicable criminal pecuniary penalty for an individual for a contravention of current subsection 146(2) of the Agvet Code is 60 penalty units. Accordingly, the corresponding criminal pecuniary penalty for a body corporate for a contravention of current subsection 146(1) of the Agvet Code will be 1,500 penalty units, and the corresponding criminal pecuniary penalty for a body corporate for a contravention of current subsection 146(2) of the Agvet Code will be 300 penalty units. By virtue of section 145AA of the Agvet Code, and the matters prescribed by current subsection 146(1) of the Agvet Code (including the application of subsection 170(5) of the Agvet Code to that subsection), the civil pecuniary penalty for new subsection 146(3) of the Agvet Code will be 900 penalty units for individuals and 7,500 penalty units for bodies corporate. By virtue of section 145AA of the Agvet Code, and the matters prescribed by current subsection 146(2) of the Agvet Code (including the application of subsection 170(5) of the Agvet Code to that subsection), the civil pecuniary penalty for new subsection 146(4) of the Agvet Code will be 180 penalty units for individuals and 1,500 penalty units for bodies corporate. The penalty provisions proposed to be created by new subsections 146(3) and (4) of the Agvet Code are expressly classified as civil penalty provisions by new subsection 146(5) of the Agvet Code. That is, new subsections 146(3) and (4) of the Agvet Code seek to create a solely pecuniary penalty in the form of a debt payable to the Commonwealth (see section 145AB of the Agvet Code). The purpose of new subsections 146(3) and (4) of the Agvet Code is to encourage compliance with the prohibition on providing false and misleading information or documents to the APVMA. New subsections 146(3) and (4) of the Agvet Code do not seek to impose criminal liability and do not lead to the creation of a criminal record. The proposed penalties will only apply to those persons who manufacture or supply agvet chemical products and are thus subject to the provisions of the Agvet Code due to those activities. That is, the penalty does not apply to the public in general. Further, the imposition of the civil pecuniary penalties in new subsections 146(3) and (4) of the Agvet Code are not dependent on a finding of guilt, and section 145AG of the Agvet Code expressly states that the contravention of a civil penalty provision is not an offence. The applicable penalty for new subsection 146(3) of the Agvet Code--being 900 penalty units for individuals and 7,500 penalty units for bodies corporate--is reflective of the seriousness of the conduct and the risk contravening behaviour may pose to human health and 58

safety, the environment and trade if agvet chemicals are used inappropriately on the basis of false or misleading information or documents. The applicable penalty for new subsection 146(4) of the Agvet Code--being 180 penalty units for individuals and 1,500 penalty units for bodies corporate--is reflective of the seriousness of the conduct and the risk contravening behaviour may pose to human health and safety, the environment and trade if agvet chemicals are used inappropriately on the basis of false or misleading information or documents. Further, the penalties proposed by new subsections 146(3) and (4) of the Agvet Code are significantly less than the civil pecuniary penalties prescribed by section 31AAA of the Therapeutic Goods Act for similar conduct in relation to the provision of false or misleading information or documents, which are 5,000 penalty units for individuals and 50,000 penalty units for bodies corporate. This reflects the lower amounts for the current offences in relation to the provision of false or misleading information or documents in the Agvet Code. Section 145AD of the Agvet Code provides that a court may make a single civil penalty order against a person for multiple contraventions of a civil penalty provision if proceedings for the contraventions are founded on the same facts, or if the contraventions form, or are part of, a series of contraventions of the same or a similar character; however, the penalty must not exceed the sum of the maximum penalties that could be ordered if a separate penalty were ordered for each of the contraventions. There are no criminal consequences associated with civil penalty orders for multiple contraventions (for example, they do not carry the possibility of imprisonment). As such, the civil penalty proposed by new subsections 146(3) and (4) of the Agvet Code are not sufficiently severe such that they could be considered to be criminal penalties for the purposes of Australia's human rights obligations. These factors all suggest that the civil penalty proposed by new subsections 146(3) and (4) of the Agvet Code are civil penalties rather than criminal penalties for the purposes of Australia's human rights obligations. Accordingly, the criminal process rights provided for by Articles 14 and 15 of the ICCPR are not engaged. However, for completeness, and to demonstrate that subsections 146(3) and (4) of the Agvet Code are nonetheless compliant with the rights provided for by Articles 14 and 15 of the ICCPR, key provisions of Division 2 of Part 9A of the Agvet Code are set out below. Article 14 of the ICCPR requires that, in the determination of criminal charges, everyone shall be entitled to a fair and public hearing by a competent, independent and impartial tribunal established by law. Various other rights are provided for persons charged with criminal offences. Due to the operation of subsection 145A(2) of the Agvet Code, the time period for the making of an application for a civil penalty order will be within 6 years of the alleged contravention. As the criminal process rights in Article 14 of the ICCPR are not engaged by subsections 146(3) and (4) of the Agvet Code, the right to be tried without undue delay provided by paragraph 14(3)(c) of the ICCPR is not engaged. Under section 145A of the Agvet Code, civil penalty orders can only be granted by a court, which must consider all relevant matters before determining the amount of the penalty. Accordingly, the right to a fair hearing is not limited. 59

Section 145BB of the Agvet Code clarifies that criminal proceedings may be commenced against a person for conduct that is the same, or substantially the same, as conduct that would constitute a contravention of a civil penalty provision, regardless of whether a civil penalty order has been made against the person in relation to the contravention. This section recognises the importance of criminal proceedings and criminal penalties in dissuading and sanctioning contraventions of the Agvet Code, and ensures that criminal remedies are not precluded by earlier civil action. Section 145BB of the Agvet Code engages the criminal process rights in Article 14 of the ICCPR, but does not limit those rights. Article 14(7) of the ICCPR provides that "no one shall be liable to be tried or punished again for an offence for which he has already been finally convicted or acquitted in accordance with the law and penal procedure of each country". This prohibition on double jeopardy is a fundamental safeguard in the common law of Australia. It means that a person who has been convicted or acquitted of a criminal charge is not to be re-tried for the same or substantially the same offence. As section 145BB of the Agvet Code permits both civil and criminal proceedings, but not multiple criminal proceedings for the same conduct, Article 14(7) of the ICCPR is not infringed. Further, section 145B of the Agvet Code provides that a court cannot make a civil penalty order against a person for a contravention of a civil penalty provision if the person has been convicted of an offence constituted by conduct that is the same, or substantially the same, as the conduct constituting the contravention. Section 145BC of the Agvet Code provides that evidence of information given, or evidence of the production of documents, by an individual is not admissible in criminal proceedings against the individual if:  the individual previously gave the information or produced the documents in proceedings for a civil penalty order against the individual for an alleged contravention of a civil penalty provision (whether or not the order was made); and  the conduct alleged to constitute the offence is the same, or substantially the same, as the conduct alleged to constitute the contravention. Section 145BC of the Agvet Code ensures that information or documents produced during civil proceedings are not relied upon to support subsequent criminal proceedings, unless those proceedings are criminal proceedings relating to falsifying evidence in civil proceedings. Accordingly, that section engages, but does not limit, the criminal process rights in Article 14 of the ICCPR. Section 145C of the Agvet Code provides that if an act or thing is required under a civil penalty provision to be done within a particular period or before a particular time, the obligation to do that act or thing continues until that act or thing is done, even if the period has expired or the time has passed. This section further provides that a person commits a separate contravention of the civil penalty provision in respect of each day during which the contravention occurs, including the day the civil penalty order is made (or any later day). This section is necessary to ensure that failure to comply with an obligation does not excuse a person from meeting that obligation. As discussed above, section 145AD of the Agvet Code provides that a relevant court may make a single civil penalty order against a person for multiple contraventions of a civil penalty provision if proceedings for the contraventions are founded on the same facts, or if the contraventions form, or are part of, a series of contraventions of the same or a similar 60

character; however, the penalty must not exceed the sum of the maximum penalties that could be ordered if a separate penalty were ordered for each of the contraventions. There are no criminal consequences associated with civil penalty orders for multiple contraventions (for example, they do not carry the possibility of imprisonment). Accordingly, the application of section 145C of the Agvet Code does not engage any human rights. Section 145CD of the Agvet Code provides that, in proceedings for a civil penalty order against a person for a contravention of a civil penalty provision, a person bears an evidential burden where that person wishes to rely on any exception, exemption, excuse, qualification or justification provided by the law creating the civil penalty provision. As section 145CD of the Agvet Code only relates to proceedings for civil penalty orders, not offences, the right to be presumed innocent in Article 14(2) of the ICCPR is not engaged. Sections 145AC, 145AE, 145AF, 145BA, 145CA, 145CB, 145CC, 145CE, 145CF and 145CG of the Agvet Code relate to:  conduct contravening more than one civil penalty provision;  the ability to hear two or more civil penalty order proceedings together;  the application of the rules and evidence and procedure for civil matters;  the stay of civil proceedings during criminal proceedings;  ancillary contraventions of civil penalty provisions;  mistake of fact;  the relevance of a person's state of mind;  liability of employees, agents or officers of a body corporate, respectively;  liability of executive officers of a body corporate; and  establishing whether an executive officer took reasonable steps to prevent the contravention of a civil penalty provision. Those provisions do not impact upon criminal proceedings and do not engage the criminal process rights in Article 14 of the ICCPR. Article 15 of the ICCPR prohibits the retrospective application of criminal laws. As the amendments proposed to the Agvet Code by Part 5 of Schedule 1 to the Bill will only apply in relation to information given, or a document produced, on or after the commencement of Part 5--being the end of the period of three months beginning on the day after the Bill receives the Royal Assent--Article 15 of the ICCPR is not engaged. There are no additional human rights implications beyond those discussed above. Summary Part 5 of Schedule 1 to the Bill is compatible with the criminal process rights provided for by Articles 14 and 15 of the ICCPR because new subsections 69ER(3), (4) and (5) of the Administration Act and new subsections 146(3), (4) and (5) of the Agvet Code do not engage those rights. Part 6 of Schedule 1--Notification about variation to Maximum Residue Limits Standard Part 6 of Schedule 1 to the Bill 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 as it does not engage any human rights. 61

Part 7 of Schedule 1--Expiry date Part 7 of Schedule 1 to the Bill 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 as it does not engage any human rights. Part 8 of Schedule 1--Other amendments Part 8 of Schedule 1 to the Bill 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 as it does not engage any human rights. Conclusion The Bill is compatible with human rights because, to the extent that it may limit human rights, those limitations are reasonable, necessary and proportionate. (Circulated by authority of the Deputy Prime Minister and Minister for Agriculture and Water Resources, the Hon. Barnaby Joyce MP) 62

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