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Agricultural and Veterinary Chemicals Legislation Amendment (Streamlining Regulation) Bill 2018

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2016-2017-2018

THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA

HOUSE OF REPRESENTATIVES

AGRICULTURAL AND VETERINARY CHEMICALS LEGISLATION AMENDMENT (Streamlining Regulation) BILL 2018

EXPLANATORY MEMORANDUM

(Circulated by authority of the Minister for Agriculture and Water Resources,

the Hon. David Littleproud MP)

 



AGRICULTURAL AND VETERINARY CHEMICALS LEGISLATION AMENDMENT (STREAMLINING REGULATION) BILL 2018

GENERAL OUTLINE

The Agricultural and Veterinary Chemicals Legislation Amendment (Streamlining Regulation) Bill 2018 (the Bill) will amend 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 Chemicals Legislation Amendment Act 2013 (the Amendment Act). The Bill will also repeal the Agricultural and Veterinary Chemicals Legislation Amendment (Removing Re-approval and Re-registration) Act 2014 (the Removing Re-approval and Re-registration Act).

The Bill will improve the effectiveness and efficiency of the national system for regulating agricultural and veterinary (agvet) chemical products. The Bill will:

·            enable the use of new, simpler regulatory processes for low risk chemical products (to simplify the approval of active constituents and labels, and the registration of certain products)

·            provide the Australian Pesticides and Veterinary Medicines Authority (APVMA) and industry with more flexibility to deal with certain types of new information provided when the APVMA is considering an application

·            provide for extensions to limitation periods and protection periods as an incentive for chemical companies to register certain new uses of chemical products—particularly those uses (minor uses) with insufficient commercial return for chemical companies to normally add to the product label

·            support computerised decision-making by the APVMA

·            provide for a legislative instrument made by the APVMA to prescribe a scheme in the future that would allow applicants and the APVMA to use accredited third party providers to undertake assessment services

·            optimise risk communication about chemical products by improving the transparency of voluntary recalls

·            harmonise the need to inform the APVMA of new information (where it relates to the safety criteria) so that the same obligations apply to all holders and applicants

·            provide a more practical mechanism for dealing with minor variations in the constituents in a product, that normally occur in the manufacturing process

·            provide the APVMA with more proportionate options for dealing with false or misleading information, and clarify what information must be included on a label

·            allow the holder of a suspended product to address the reason for the suspension

·            fix anomalies in the regulation-making powers for the labelling criteria

·            simplify the APVMA’s corporate reporting requirements

·            make minor and machinery changes including removal of unnecessary and redundant provisions.

National Registration Scheme

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 APVMA. The control of agvet chemical use after supply is the responsibility of individual states and territories.

The NRS is implemented, in part, through the Code Act. The Code Act contains, as a schedule, the Agricultural and Veterinary Chemicals Code (the Agvet Code). The Agvet Code operates in each state, the Northern Territory and each participating territory (the Australian Capital Territory and Norfolk Island) to constitute a single national Agvet Code applying throughout Australia.

The Administration Act and the Code Act, including the Agvet Code and any regulations or legislative instruments made under these laws, are collectively described as agvet legislation.

Consultation

An exposure draft of the Bill was released for public consultation in July and August 2018. Relevant state and territory authorities and appropriate Commonwealth agencies were also consulted. 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.

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.

 



ACRONYMS, ABBREVIATIONS AND COMMONLY USED TERMS

AAT

Administrative Appeals Tribunal

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 Code)

the Agricultural and Veterinary Chemicals Code, as set out in the Schedule to the Agricultural and Veterinary Chemicals Code Act 1994

Amendment Act

Agricultural and Veterinary Chemicals Legislation Amendment Act 2013

APVMA

Australian Pesticides and Veterinary Medicines Authority

ARC

Administrative Review Council 

Code Act

Agricultural and Veterinary Chemicals Code Act 1994

Code Regulations

Agricultural and Veterinary Chemicals Code Regulations 1995

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 Commonwealth Offences

the Guide to Framing Commonwealth Offences, Infringement Notices and Enforcement Powers published by the Attorney-General’s Department

ICCPR

the International Covenant on Civil and Political Rights

the minister

the minister administering the Agricultural and Veterinary Chemicals (Administration) Act 1992

NRS

National Registration Scheme

Operational Efficiency Act

Agricultural and Veterinary Chemicals Legislation Amendment (Operational Efficiency) Act 2018

PGPA Act

Public Governance, Performance and Accountability Act 2013

the record

Record of Approved Active Constituents for Chemical Products kept under section 17 of the Agvet Code

Record of permits

the record of permits kept under section 113 of the Agvet Code

the register

Register of Agricultural and Veterinary Chemical Products kept under section 18 of the Agvet Code

Relevant APVMA file

the file in which information about approved labels is recorded as mentioned in paragraph 21(c) of the Agvet Code.

Removing Re-approval and Re-registration Act

Agricultural and Veterinary Chemicals Legislation Amendment (Removing Re-approval and Re-registration) Act 2014



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 (Streamlining Regulation) Act 2018 .

Clause 2         Commencement

Clause 2 provides for the commencement of each provision in the Bill, as set out in the table. The Bill provides for a staged introduction of measures. This will allow relevant subordinate laws to be developed and allow industry to be informed of new obligations. This approach will also allow the APVMA sufficient time to appropriately and incrementally implement necessary changes to policies, procedures and training protocols as a result of the amendments, while minimising any impact on its regulatory role.

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 Parts 1 and 2 of Schedule 1 to the Bill will commence on the day after the end of the period of 6 months beginning on the day the Bill receives the Royal Assent. Part 1 deals with simplified processes for the approval of active constituents and labels. Part 2 deals with giving industry and the APVMA more flexibility to deal with certain types of information provided during an application assessment. Deferring commencement for 6 months is necessary to allow the associated regulations and other legislative instruments to be developed for these measures, including consultation on these instruments.

Item 3 and 4 in the table provides that Part 3 (which deals with extending protection and limitation periods) and Part 4 of Schedule 1 to the Bill (which deals with computerised decision-making) will commence on a day to be fixed by Proclamation or 6 months after the Bill receives the Royal Assent (whichever is the earlier). This is necessary to allow the government to develop necessary regulations and provide the APVMA with sufficient time to appropriately implement necessary changes to policies, procedures and training protocols as a result of implementing extended data protection and computerised decision-making.

Item 5 in the table provides that Part 5 of Schedule 1 to the Bill (which deals with accreditation of assessors) will commence 12 months beginning on the day the Bill receives the Royal Assent. This is necessary to allow the associated regulations and other legislative instruments to be developed for these measures, including consultation on these instruments.

Item 6 in the table provides that Parts 6 (which deals with voluntary recalls) and 7 (which deals with new information requirements) of Schedule 1 to the Bill will commence on the day after the end of the period of 3 months beginning on the day the Bill receives the Royal Assent. Deferring commencement for 3 months is necessary to ensure the APVMA can inform industry of their obligations for voluntary recalls and new information requirements.

Item 7 in the table provides that Parts 8 to 10 of Schedule 1 to the Bill will commence on the day after the Bill receives the Royal Assent. Part 8 deals with variations in the constituents in a product. Parts 9 and 10 deal with false or misleading information and what information must be included on a label.

Item 8 provides that Part 11 of Schedule 1 to the Bill commences on the later of the day after the Bill receives the Royal Assent, and immediately after the commencement of Part 4 of Schedule 1 to the Agricultural and Veterinary Chemicals Legislation Amendment (Operational Efficiency) Act  2018 (Operational Efficiency Act). This is because the amendments in Part 11 of Schedule 1 to the Bill are drafted on the basis that Part 4 of Schedule 1 to the Operational Efficiency Act will have already commenced. Item 8 therefore also provides that the amendments in Part 11 of Schedule 1 to the Bill do not commence at all if Part 4 of Schedule 1 to the Operational Efficiency Act does not commence. Part 11 of Schedule 1 to the Bill provides the holder of a suspended product with a more practical avenue to address the reason for the suspension.

Item 9 in the table provides that Part 12 of Schedule 1 to the Bill will commence on the day after the Bill receives the Royal Assent. Part 12 deals with anomalies in the regulation-making powers for the safety, efficacy, trade and labelling criteria.

Item 10 in the table provides that Part 13 of Schedule 1 to the Bill (removing annual operational plans) will commence on 1 January 2020 as this is the most practical day on which these measures can commence.

Item 11 in the table provides that Part 14 (other amendments) of Schedule 1 to the Bill will commence on the day after the Bill receives the Royal Assent.

Item 12 in the table provides that Schedule 2 to the Bill (other amendments) 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.



 

Schedule 1—Main Amendments

PART 1—APPROVAL AND REGISTRATION FOR PRESCRIBED ACTIVE CONSTITUENTS, CHEMICAL PRODUCTS OR LABELS

Overview

Part 1 of Schedule 1 to the Bill amends the Agvet Code to provide the APVMA with greater flexibility to manage applications and to align regulatory effort with risk, similar to the APVMA’s existing streamlined options for prescribed variations to approvals or registrations. This will be achieved by providing for both:

·            prescribed approvals of active constituents and labels

·            prescribed registrations of chemical products.

Divisions 2AA (notifiable variations) and 2A (prescribed variations) of Part 2 of the Agvet Code provide for streamlined variations to the relevant particulars of approvals and registrations. These processes provide for variations with reduced information requirements and lighter-touch ‘assessments’ (for example there will be no requirement for a preliminary assessment), where the risks associated with a variation warrant such an approach. This reduces the time and effort for industry to make—and for the APVMA to deal with—these particular variations. The types of variations to approvals and registrations that can be made as notifiable variations and prescribed variations are set out in the Code Regulations and a legislative instrument made by the APVMA.

The Agvet Code also provides for a person to apply for a new registration of a chemical product, or an approval of an active constituent or label for containers for a chemical product (section 10). However, there are currently no means to provide for approvals and registrations to be made by the APVMA through a simplified model, similar to notifiable or prescribed variations.

The proposed amendments will enable both the Code Regulations and a legislative instrument made by the APVMA to specify kinds of approvals and registrations that the APVMA can determine as either prescribed approvals or prescribed registrations. This change will introduce a system change to enable the use of new, simpler regulation processes for these approvals and registrations where minimal or no assessment of technical information occurs. These changes would better align regulatory effort with risk and therefore improve access to safe and effective chemical products by reducing some of the red tape and reducing some of the costs associated with approval and registration.

The proposed amendments will be similar to the existing provisions for prescribed variations to approvals and registrations (including no requirement for a preliminary assessment), with safeguards to ensure that only safe and effective products continue to be available.

Agricultural and Veterinary Chemicals Code Act 1994

Item 1             Section 3 of the Code set out in the Schedule

Item 1 inserts provisions into section 3 of the Agvet Code for new definitions for ‘prescribed active constituent’, ‘prescribed chemical product’ and ‘prescribed label for containers for a chemical product’. These provisions are necessary to ensure that readers of the Agvet Code can easily locate these definitions.

Items 2 and 3                         Section 9A of the Code set out in the Schedule

Item 2 inserts a new heading in the Agvet Code for the explanation of subdivision A of Division 2 of Part 2 of the Agvet Code. Subdivision A is an explanation of the approval of active constituents and labels and registration of chemical products, including applications for approval and registration.

Item 3 repeals the existing subsections 9A(2) to (5) and inserts new subsections 9A(2) to (5B) and new headings. Section 9A explains the provisions in Part 2 of the Agvet Code that include existing sections 10, 11, 12, 13 and 14 of the Agvet Code and new sections 14C, 14D and 14E (which relate to prescribed active constituents and chemical products). These sections specify how persons apply for approval and registration (an application can be made under section 10 or 14C, 14D or 14E) and how the APVMA deals with these applications.

Item 4             After section 9A of the Code set out in the Schedule

Item 4 inserts a new heading in the Agvet Code to identify subdivision B of Division 2 of Part 2 of the Agvet Code. Subdivision B includes the current provisions that provide for the approval of active constituents and labels and registration of chemical products, including applications for approval and registration (sections 10 to 14B of the Agvet Code).

Item 5             After section 14B of the Code set out in the Schedule

Item 5 inserts a new subdivision C into Division 2 of Part 2 of the Agvet Code and a new subdivision D heading into Division 2 of Part 2 of the Agvet Code. Subdivision C includes the provisions that provide for the approval of prescribed active constituents and labels and the registration of prescribed chemical products (new sections 14C, 14D and 14E of the Agvet Code). This provides for a streamlined means of approving active constituents and labels and registering chemical products.

Applications for prescribed approvals and registrations

New sections 14C, 14D and 14E provide for a person to apply for the approval of a prescribed active constituent, approval of a prescribed label or registration of a prescribed chemical product as a prescribed approval or registration. These prescribed approvals and registrations represent a new approval or registration process that will be quicker and less costly than the current approval or registration process.

This prescribed approval or registration would only apply for an approval or registration that is of a kind determined by the APVMA in a legislative instrument or prescribed in the regulations (see paragraph 14C(4)(b), subsection 14D(4) and paragraph 14E(4)(b)). Each prescribed chemical product that is registered requires a label approval and therefore subsection 14E(7) also specifically provides that prescribed labels for containers for chemical products may be described by reference to a kind of chemical product.

The kinds of active constituents and chemical products subject to prescribed approvals and registrations are anticipated to be those that have sufficiently low associated risk as to warrant reduced supporting information requirements. Examples may include certain:

·            applications involving well-characterised chemistry or existing pharmacopoeial active constituents

·            products with a history of safe use

·            applications with assessments conducted by accredited third party providers.

For these active constituents and chemical products it is conceivable that no technical information may be required and, as such, this mechanism could support the introduction of a means of self-approval or self-registration, where appropriate. This new process closely mirrors the existing process (including there being no requirement for a preliminary assessment) for prescribed variations where approvals and registrations are varied through a simplified process.

To ensure that active constituents, chemical products and labels continue to comply with the safety, efficacy, trade and labelling criteria, the APVMA can only include a kind of prescribed approval or registration in its legislative instrument if it is satisfied that:

·            the prescribed active constituent would meet the safety criteria (subsection 14C(5))

·            the prescribed chemical product would meet the safety, efficacy and trade criteria or comply with the established standard (subsection 14D(5))

·            the prescribed label for the containers for the chemical product would meet the labelling criteria or comply with the established standard (subsection 14E(5)).

The application for a prescribed approval or registration would need to meet the application requirements (subsections 14C(2), 14D(2) and 14E(2)). If the application does not meet the application requirements then the APVMA would be required to notify the applicant of the reasons why before it refuses the application (current section 8S).

The APVMA may alter the application with the written consent of the applicant (subsections 14C(3), 14D(3) and 14E(3)). This provides a means for the APVMA to efficiently deal with simple discrepancies in an application. For this reason (and to reflect the existing provisions for prescribed variations) a preliminary assessment of applications for prescribed approvals or registrations is not required.

The APVMA may also, by legislative instrument, set out disqualifying criteria that apply to the applicant for prescribed approvals and registrations (subsections 14C(9), 14D(9) and 14E(10)). These criteria could, for example, set out the circumstances to allow the APVMA to have regard to the regulatory history of the applicant, or consider if applicants have been convicted of an offence, ordered to pay a civil pecuniary penalty or had a registration or approval cancelled or suspended for breaching a condition or providing false or misleading information. Applicants disqualified through this mechanism will still be able to apply for approvals and registrations under section 10 of the Agvet Code.

As required by new subsections 14C(7), 14D(7) and 14E(8) the APVMA must approve the active constituent, register the chemical product or approve the label for containers of a chemical product that is the subject of the application if it is satisfied that:

·            the application meets the application requirements

·            the active constituent is a prescribed active constituent (subsection 14C(7)), the chemical product is a prescribed chemical product (subsection 14D(7)), or the label is a prescribed label for containers of a chemical product (subsection 14E(8)); and

·            none of the disqualifying criteria apply in relation to the applicant.

If the APVMA is not satisfied that these criteria are met then the APVMA must refuse the application (subsections 14C(8), 14D(8) and 14E(9)), subject to a notice of proposed refusal issued under existing section 8S of the Agvet Code.

The decision about the application must be made within the period prescribed in the regulations. If the decision is not made within this period, the applicant has the opportunity to have the application deemed to be refused and considered by the Administrative Appeals Tribunal. This process is the same process that currently applies for other applications not dealt with by the APVMA within the application timeframe (see section 165 of the Agvet Code).

Item 6             Paragraphs 17(3)(a) and (b) of the Code set out in the Schedule

Item 6 inserts the reference to new section 14C in paragraphs 17(3)(a) and (b) of the Agvet Code. This ensures that the relevant details for an active constituent approved under section 14C (a prescribed active constituent) are recorded in the Record of Approved Active Constituents for Chemical Products (the record). This requirement is the same as that for existing approved active constituents.

Items 7 and 8                         Section 34G of the Code set out in the Schedule

Items 7 and 8 insert new subsection 34G(1AA), and a reference to subsection 34G(1AA) in subsection 34G(1B) of the Agvet Code. These amendments ensure that information that is subject to a limitation period (under Division 4A of Part 2 of the Agvet Code) cannot be used by the APVMA when determining an application made under section 14C, 14D or 14E. This reflects the restriction that currently applies to other applications for approval or registration. This limitation on use applies to information given to the APVMA in an application made under sections 10 or 27 or information provided as required by section 161 of the Agvet Code.

By limiting the use of information, the original producer of that information (the ‘innovator’) can prevent competitors (such as producers of generic products) from using the innovator’s data, or can seek compensation from the competitors for the information it has produced. This benefits the innovator, who has incurred the cost of generating this information and testing the market, and so promotes innovation.

Item 9             Subparagraph 166(1A)(b)(i) of the Code set out in the Schedule

Item 9 inserts references to new subsections 14C(8), 14D(8) and 14E(9) in subparagraph 166(1A)(b)(i) of the Agvet Code. This provides for persons to apply for an internal review of a decision by the APVMA to refuse an application for approval of either a prescribed active constituent or prescribed labels for containers for chemical products or for registration of a prescribed chemical product.

This mirrors the internal review available for the existing processes for approvals and registrations when an application is refused by the APVMA for not meeting the application requirements set out in paragraphs 8A(a) and (b) of the Agvet Code.

Item 10           Paragraph 167(1)(a) of the Code set out in the Schedule

Item 10 inserts references to new paragraphs 14C(7), 14D(7) and 14E(8) in paragraph 167(1)(a) of the Agvet Code. This provides for review by the Administrative Appeals Tribunal (AAT) of a decision to approve a prescribed active constituent or prescribed labels for containers for chemical products or to register a prescribed chemical product. This mirrors the AAT review available for the existing processes for approvals and registrations where that approval or registration is made with an instruction or relevant particular other than that out in the application, or where the approval or registration is subject to particular conditions.

Item 11           Paragraph 167(1)(b) of the Code set out in the Schedule

Item 11 inserts references to new paragraphs 14C(8), 14D(8) and 14E(9) in paragraph 167(1)(b) of the Agvet Code. This provides for review by the AAT of a decision by the APVMA to refuse an application for approval of either a prescribed active constituent or prescribed labels for containers for chemical products or for registration of a prescribed chemical product.

However, a review by the AAT is not available when a decision to refuse was based only on not meeting the application requirements set out in paragraphs 8A(a) and (b) of the Agvet Code (such decisions are limited to internal review; see item 9).

This AAT review mirrors that available for the existing processes for approvals and registrations.



 

PART 2—INFORMATION TO BE TAKEN INTO ACCOUNT IN DETERMINING APPLICATIONS

Overview

Part 2 of Schedule 1 to the Bill amends the Agvet Code to provide the APVMA and industry with more flexibility to deal with certain types of information given while the APVMA is determining an application. The kinds of information would be prescribed in the regulations.

Under section 8C of the Agvet Code, the APVMA is restricted from considering new information provided by, or on behalf of, the applicant during the assessment period for the application. Despite section 8C the APVMA may, at its discretion, issue a notice to an applicant under section 159 of the Agvet Code seeking additional clarifying information. The first such notice compulsorily triggers a one-off extension to the statutory time period in which the application must be assessed. This extension is typically equivalent to one third of the statutory assessment period for the original application (rounded up to the nearest whole month) plus an additional month. While the fixed extension period is intended to provide certainty to the applicant about when the application will be determined, this period may be excessive for requests for simple clarifying information (related to information that has already been provided in the original submission). The only alternative for an applicant to provide such information is to do so in a variation application made after the active constituent or label has been approved or the product has been registered. This can create inefficiencies for the APVMA and the applicant (adding costs, time and administrative burden).

Agricultural and Veterinary Chemicals Code Act 1994

Item 12           Subsection 8C(2) of the Code set out in the Schedule

Item 12 amends section 8C of the Agvet Code to provide that the operation of subsection 8C(2) is subject to new subsection 8C(2A) of the Agvet Code. Subsection 8C(2) currently prevents the APVMA from considering information provided by, or on behalf of, the applicant during the assessment period for an application. The amendment provides for the APVMA to be able to consider the kinds of information that would be prescribed in regulations for new subsection 8C(2A) (inserted by item 13) during the assessment period for an application.

Item 13           After subsection 8C(2) of the Code set out in the Schedule

Item 13 inserts new subsection 8C(2A) that allows the regulations to prescribe certain kinds of information that the APVMA may consider during the assessment period for an application (for example, providing an updated good manufacturing practice certificate), removing the need for:

·            a notice under section 159 of the Agvet Code, with the associated extension of the assessment period; or

·            a variation application.

Item 14           Application provision

Item 14 provides that the amendments to section 8C made by Part 2 of Schedule 1 to the Bill will apply in relation to an application lodged on or after the commencement of this Part and will also apply in relation to applications lodged before the commencement of this Part if those applications have not been determined by the APVMA before commencement.

PART 3—LIMITS ON USE OF INFORMATION

Overview

Part 3 of Schedule 1 to the Bill amends the Agvet Code to provide incentives for the chemicals industry to seek approval of certain kinds of active constituents with new, desirable features (such as new modes of action to manage resistance) or to register certain uses (priority uses) of chemical products. The incentive involves extending the period of time that information that was used to assess an application or reconsideration for a chemical product or active constituent, is protected from use by other applicants by up to five years. This will be particularly suited to those uses (commonly called minor uses) where only a low economic return is expected. It is anticipated that many minor uses will be considered priority uses that qualify for the data protection extensions.

An innovator funds the production of information to support a new active constituent (or improved characteristics for an existing active constituent) or a new use of a chemical product. Limiting the use of information prevents competitors from using innovators’ data or allows innovators to seek compensation from the competitors for use of the innovators’ information. This benefits the innovator, who has incurred the cost of generating this information, and promotes innovation.

The Agvet Code provides for two kinds of data protection:

·            ‘Limits on use of information’ (Division 4A of Part 2) relates to information provided to the APVMA as part of an application made under sections 10 or 27 of the Agvet Code or as relevant information under section 161 of the Agvet Code. If the information is relied on by the APVMA in making a decision, it receives a ‘limitation period’. The limitation periods for this information are set out in section 34M of the Agvet Code and range from three years to a maximum of 10 years depending on the application. During the limitation period, the APVMA may not use the information to assess or make a decision on another application or on a reconsideration unless an exception applies (for example, the authorising party has provided consent for the information to be used).

·            ‘Protected information’ is certain kinds of information (that relate to either an active constituent that has been approved or a chemical product that has been registered) provided as part of a reconsideration (sometimes referred to as a chemical review). A protection period of eight years applies to this information, commencing from the time the APVMA makes its decision on the reconsideration.

The period during which the information cannot be used is sometimes known as a ‘data protection period’.

The existing data protection period is insufficient for some new active constituents or product uses to be brought to market. This is especially true for those actives and uses that are not expected to produce sufficient economic return to offset the cost of approval or registration (including data generation). Some active constituents or uses that are unlikely to be introduced into Australia in a timely fashion under the existing market dynamics may be particularly important to Australia and could include those needed to support agricultural productivity or to control weeds and pests of national significance. The amendments in Part 4 of the Bill help overcome this barrier.

Encouraging the inclusion of more priority uses on product labels is also anticipated to reduce the regulatory burden on product users who may otherwise need to seek permits under Part 7 of the Agvet Code.

The requirements for extending these periods will include technical detail. For this reason, Part 3 of the Bill also provides (through amendments to the Agvet Code) that the regulations will specify most of the details for extending limitation and protection periods. Consistent with international practice the main application of these measures will be for information for agricultural chemical products and it is anticipated that regulations for these products will be the priority.

Agricultural and Veterinary Chemicals Code Act 1994

Items 15 and 18         Section 3 of the Code set out in the Schedule

Items 15 and 18 are consequential amendments to the definitions of ‘limitation period’ and ‘protection period’ in section 3 of the Agvet Code. The amendments insert notes after these definitions to reflect the insertion of new sections 34MA and 34KA (in, respectively, amending items 25 and 22).

Items 16 and 17         Section 3 of the Code set out in the Schedule

Items 16 and 17 are consequential amendments to the definitions of ‘protected active constituent’ and ‘protected chemical product’ in section 3 of the Agvet Code. The amendments reflect that the protection period in these definitions would include any period that is extended as a result of an extension under new section 34KA (in amending item 22).

Items 19 and 20         Section 34F of the Code set out in the Schedule

Items 19 and 20 are consequential amendments to section 34F of the Agvet Code. Section 34F is a section that explains the provisions in Division 4A of Part 2 of the Agvet Code (which deals with information with limits on its use). The amendments update section 34F so that it reflects the insertion of new sections 34KA and 34MA (in, respectively, amending items 22 and 25).

Item 21           Subsection 34J(5A) of the Code set out in the Schedule

Item 21 replaces subsection 34J(5A) of the Agvet Code. Section 34J of the Agvet Code deals with conditions where the APVMA may use information to determine an application where there is either protected information or information with limits on its use. The amendment is a consequential amendment to subsection 34J(5A) so that it reflects where a protection period is extended under new section 34KA (in amending item 22).

Item 22           After section 34K of the Code set out in the Schedule

Item 22 inserts new section 34KA into the Agvet Code. Section 34KA provides for the regulations to extend the protection period for protected information (and end such an extension), as a result of a prescribed application that is made to the APVMA. For example, an application to:

·            approve an active constituent that is of a kind prescribed in the regulations

·            register, or vary a registration of, a chemical product for a kind of use that is prescribed in the regulations.

If there are multiple kinds of information that are protected information then it is anticipated that the protection period for each of these kinds of information can be extended if the information is eligible for extension.

Section 34KA includes restrictions on when the protection period can be extended and how long this period can be extended:

·            New subsections 34KA(2) and (3) provide that an application for an extension of a protection period is not required. Instead an extension is a consequence that follows when particular applications (of a kind prescribed in regulations) are lodged and these applications also satisfy any requirements that may be prescribed by the regulations. It is anticipated that these applications would relate to products with new, desirable features. For example, products for minor or priority uses, where the costs of registering these uses are not otherwise justified by the additional commercial returns to chemical manufacturers. In addition, the application must be lodged while there is at least three years of the existing protection period remaining. The purpose of this three year period is to reduce the impact on potential applicants, allowing them to have certainty as to when a protection period will end, and they can consider entering the market based on the protected information. This approach mirrors similar practices used in other countries.

·            New subsection 34KA(4) provides that a protection period can only be extended for a maximum of five years. This extension is consistent with the approach used in other countries and is considered to be the best balance between providing incentives to innovators with increased data protection, while allowing competitors to access protected information at a suitable time.

Items 23 and 24         Subsection 34M(1) of the Code set out in the Schedule

Items 23 and 24 are consequential amendments to subsection 34M(1) of the Agvet Code to reflect the insertion of new section 34MA in amending item 25.

Item 25           At the end of Division 4A of Part 2 of the Code set out in the Schedule

Item 25 inserts new section 34MA into the Agvet Code. Section 34MA mirrors new section 34KA but applies extensions to information subject to a limitation period (and ending such an extension).

Information has limits on its use if it is information provided as part of certain applications (set out in the table to subsection 34M(1)) and the APVMA relies on the information to approve an active constituent or label, register a product or vary an approval or registration. The limitation periods that apply to this information depend upon the nature of the application made to the APVMA. These limitation periods commence from the time the APVMA approves an active constituent or label, registers a product or varies an approval or registration.

Section 34MA provides for the regulations to extend the limitation period for information, as a result of a prescribed application that is made to the APVMA. For example, an application to:

·            approve a particular kind of active constituent that is prescribed in the regulations; or

·            register, or vary a registration of, a chemical product and approve a label for a chemical product for a kind of use that is prescribed in the regulations.

If there are multiple kinds of information that are limited information, then section 34MA provides that the limitation period for each of these kinds of information can be extended if the information is eligible for extension.

Similar to new section 34KA, section 34MA provides for regulations to prescribe when limitation periods can be extended and for how long. Specifically, section 34MA provides:

·            for restrictions on when the limitation period can be extended and for how long

·            that an application for an extension of a limitation period is not required—an extension is a consequence that follows when particular applications (of a kind prescribed in regulations) are lodged and these applications also satisfy any requirements that may be prescribed by the regulations

·            that the application must be lodged while there is at least three years of the existing limitation period remaining

·            that a limitation period can only be extended for a maximum of five years.

Item 26           Paragraph 59(2)(c) of the Code set out in the Schedule

Item 26 is a consequential amendment to paragraph 59(2)(c) of the Agvet Code to reflect that the protection period for information can be extended. Section 59 of the Agvet Code deals with when the APVMA may use protected information and it is appropriate that this reflects the extension under new section 34KA.

Item 27           Application provisions

Item 27 provides that new sections 34KA and 34MA apply in relation to a protection period or limitation period that begins before, on or after the Part commences and means that currently protected or limited information is eligible for extension. The regulations will deal with which applications are eligible to trigger an extension, including the eligibility of any applications lodged before commencement.



 

PART 4—COMPUTERISED DECISION-MAKING

Overview

Part 4 of Schedule 1 to the Bill amends the Agvet Code to provide that the APVMA may choose to use computerised decision-making as part of its processes, thereby increasing efficiency. For example, computerised decision-making might be used for decisions involving an administrative check of an application.

While the Agvet Code deals with electronic transactions, it does not currently provide for the use of computer programs to make decisions. Accordingly, all decisions, including those of a largely administrative nature, require an APVMA staff member to turn their minds to the matter at hand, the proposed amendments address this deficiency by allowing computerised decision making.

The proposed amendments align the Agvet Code with other Commonwealth legislation that also authorises computerised decision making (for example the therapeutic goods legislation).

The APVMA’s decisions about implementing computerised decision-making will be guided by the best practice principles developed by the Administrative Review Council (ARC), as outlined in the ARC report Automated Decision Making (ARC Report No. 46, 2004), available from the website of the Attorney-General’s Department.

The Bill provides for a specific commencement provision for Part 4 to allow procedures and guidance to be developed in line with these best practice principles.

Agricultural and Veterinary Chemicals Code Act 1994

Item 28           Before section 6 of the Code set out in the Schedule

Item 28 inserts new section 5F. This allows the APVMA to introduce computerised decision-making where the APVMA considers that this is appropriate, and is intended to establish a flexible legislative regime that will support future developments in information technology and business processing. This provision does not require the APVMA to use computerised decision-making, but rather provides it as an option.

New subsection 5F(1) provides for the APVMA to arrange for the use of computer programs for any purpose where the APVMA may or must make a decision, exercise a power, comply with an obligation or anything else related to these actions.

New subsection 5F(2) provides that the decision made by the computer program is taken to be a decision made by the APVMA with all the consequences that would flow from this. This is consistent with Principle 5 of the best practice principles developed by the ARC, as outlined in the ARC Report No. 46, 2004. This principle states that the use of an expert system to make a decision—as opposed to helping a decision-maker make a decision—should be legislatively sanctioned to ensure that it is compatible with the legal principles of authorised decision-making.

New subsection 5F(3) allows the APVMA to substitute a decision for a decision made by a computer program if the APVMA is satisfied that the decision made by the computer program is incorrect. This allows the APVMA to fix an error and minimise the impact on the persons affected by any incorrect decision made by the computer program. This provides a safeguard to ensure that if a computer program is not operating correctly, or has produced a decision that the APVMA considers is wrong, the action can be substituted by the APVMA without the need for formal administrative review. This is consistent with Principle 6 of the best practice principles developed by the ARC, as outlined in ARC Report No. 46, 2004. This principle states that if decisions made by or with the assistance of expert systems can be overridden only by a senior officer, it might be advantageous for this to be legislatively clarified.

New subsection 5F(4) specifies that the APVMA may only substitute a decision for a decision made by a computer program within 60 days of the day the decision is made by the computer program. This provision ensures that there is a clear ‘window’ in which the APVMA may substitute a decision.

Items 29, 31 and 33   Paragraphs 166(1)(a) and (1A)(a) and after subsection 166(1A) of the Code set out in the Schedule

Items 29 and 31 amend paragraphs 166(1)(a) and (1A)(a) to provide that a decision made under paragraph 5F(2)(a) by a computer program may be reconsidered by the APVMA. This will mean that a decision made by a computer program will be subject to the same opportunity for internal reconsideration as if that decision were made by an APVMA staff member. In addition, amended paragraph 166(1)(a) and new subsection 166(1B), inserted by item 33, provide the same opportunity for internal reconsideration that applies if the decision by a computer program is substituted by an APVMA decision under subsection 5F(3) of the Agvet Code.

Item 29 also replaces the existing definition of ‘original decision’ with ‘reviewable decision’ for clarity.

Item 30, 32 and 34     Paragraphs 166(1)(b), 166(1A)(b) and (c) and subsections 166(2) to (4A) and (5) to (7) of the Code set out in the Schedule

Items 30, 32 and 34 amend paragraphs 166(1)(b), 166(1A)(b) and (c), and subsections 166(2) to (4A) and (5) to (7) of the Code set out in the Schedule to replace all occurrences of ‘original decision’ with ‘reviewable decision’ as a consequential amendment to items 29 and 31.

Item 35           After subsection 167(2A) of the Code set out in the Schedule

Item 35 inserts new subsection 167(2B) to provide that where the APVMA substitutes a decision under subsection 5F(3) then that decision may be reviewed on application to the AAT. However, if the initial decision was not reviewable by the AAT, then the amendment in item 35 has the result that the substituted decision is also not reviewable by the AAT.

Item 36           Application and saving provisions

Item 36 provides that the amendments to section 166 of the Agvet Code made by Part 4 of Schedule 1 to the Bill will apply in relation to reviewable decisions made on or after the commencement of this Part. It also provides that section 166 as in force before commencement of this item is preserved in relation to original decisions made before commencement of the item.



 

PART 5—ACCREDITATION OF ASSESSORS

Overview                                          

Part 5 of Schedule 1 to the Bill amends the Administration Act and Agvet Code to provide for the APVMA to make a disallowable legislative instrument (in the future) that prescribes an accreditation scheme for assessors. An accreditation scheme will enable the APVMA to recognise assessments from accredited third party providers.

The scheme would have broad application to support the APVMA and could be used to accredit persons (which can include a body politic or corporate as well as an individual) for a range of purposes in the future, such as:

·            roles accredited persons might undertake directly with industry, including preparing assessment reports that would then be included in applications made to the APVMA (similar to the approach currently used in New Zealand)

·            roles the APVMA currently undertakes, but which could instead be undertaken by accredited assessors in the future, such as conducting assessments of information in applications made to the APVMA (APVMA-initiated assessments by accredited external assessors).

Moving the function of conducting or commissioning data assessments from the APVMA to third-party providers has the potential to:

·            provide applicants with greater flexibility over data assessment timeframes and costs

·            simplify administration processes within the APVMA

·            increase efficiency of application processing

·            open data assessment to greater competition.

These measures will allow the APVMA to accredit persons for assessments of information the APVMA receives. The APVMA’s legislative instrument will provide community confidence in the assessors of agvet chemical products as it could, for example, specify requirements for experience, insurance, conflict of interest measures and data handling protocols. The instrument could also include requirements for an audit and compliance program. This would help ensure quality and consistency, and safeguard the integrity of the third party assessment process.

It is anticipated that there would be sanctions for contravening conditions of accreditation to ensure that accredited persons comply with such conditions. Criminal and civil sanctions may be prescribed in regulations.

It is also anticipated that the accreditation scheme will be cost recovered. Any charges will be developed in accordance with the Australian Government Charging Framework including the Australian Government Cost Recovery Guidelines. The specific charges will need to be developed following consultation on the details of the accreditation scheme and would be prescribed in regulations made under section 164 of the Agvet Code.

Agricultural and Veterinary Chemicals (Administration) Act 1992

Item 37           Section 4

Item 37 inserts a new definition of ‘accredited person’ as meaning a person who is accredited in accordance with an instrument made under section 6G of the Agvet Code, the same as the new definition introduced into the Agvet Code by item 39.

Item 38           Paragraph 69ES(3)(c)

Item 38 inserts ‘accredited person’ into paragraph 69ES(3)(c) of the Administration Act. The effect of this amendment is to enable an evidential certificate issued by the APVMA to certify that a person was an accredited person at a particular time or during a particular period, in the same way that the APVMA can currently issue a certificate about an inspector. This certification can be used to clarify the status of a person at a particular time or during a particular period, including for legal proceedings.

Agricultural and Veterinary Chemicals Code Act 1994

Item 39           Section 3 of the Code set out in the Schedule

Item 39 inserts a new definition of ‘accredited person’ to introduce the concept of an accredited assessor into the Agvet Code for the purposes of establishing accreditation schemes for persons under section 6G of the Agvet Code.

Item 40           At the end of subsection 6A(1) of the Code set out in the Schedule

Item 40 amends subsection 6A(1) of the Agvet Code to include a reference to an instrument made under section 6G of the Agvet Code (item 43) so the APVMA can make guidelines about performing its functions and exercising its powers under the section 6G instrument. This provides a general ability for the APVMA to create a section 6A guideline and, if the APVMA makes such a guideline, requires the APVMA to have regard to the guideline and that it must be published on the APVMA’s website.

Items 41 and 42         At the end of subsections 6C(1) and (2) of the Code set out in the Schedule

Items 41 and 42 amend subsections 6C(1) and (2) of the Agvet Code to include references to an instrument made under section 6G of the Agvet Code (item 43) to make clear that the APVMA can use any information for accrediting persons.

Item 43           Before section 7 of the Code set out in the Schedule

Item 43 inserts new section 6G into the Agvet Code to allow a legislative instrument made by the APVMA to prescribe matters relating to accredited persons. This instrument would be disallowable under section 163A of the Agvet Code and so would be subject to parliamentary scrutiny when made or amended.

Accreditation scheme

For new section 6G, the matters that may be prescribed relate to matters relevant for the purposes of the Agvet Code and where those roles are set out in the instrument (including assessing information of a kind set out in the instrument). This new provision allows a legislative instrument to prescribe an accreditation scheme for assessors of information.

It is anticipated that assessors of technical information for agvet chemicals could be located anywhere in the world as the expertise for assessing agvet chemicals is not limited to Australian citizens or residents. Paragraph 6G(1)(a) allows for this.

While the scope of the accreditation is limited to the purposes of the Agvet Code, subsection 6G(2) describes some examples of the scope of the accreditation scheme. These examples do not limit the scope of the accreditation scheme and are included to make clear the types of conditions and requirements that may be applied to accredited persons.

Incorporation of technical material

New subsection 6G(3) provides for the accreditation scheme legislative instrument to incorporate matters by applying, adopting or incorporating, with or without modification, any matter contained in an instrument or other writing as in force or existing from time to time. This provision is necessary to ensure that the legislative instrument may adopt contemporary standards and requirements (as amended from time to time) when describing conditions of accreditation. This will ensure accredited persons can use the latest standards when assessing relevant material about agvet chemicals.

Standards for agvet chemicals set out important requirements relating to safety and efficacy that must be complied with. It is anticipated that similar standards would be developed for the assessment of information about the safety and efficacy of chemical products. In developing these it is likely that the APVMA will seek to align with international standards.

Given that standards for accredited persons will need to be amended regularly to reflect the latest technical requirements and to ensure that the most appropriate formats for assessment reports are used by accredited persons, it would not be practicable to remake the relevant instrument every time a standard is amended. This is resolved by allowing the adoption of documents as in force from time to time, reducing the costs to industry and accredited persons in maintaining the cost-recovered scheme.

New subsection 6G(3) is consistent with the approach currently used for standards that the APVMA may develop under section 6E of the Agvet Code, which provides for the incorporation of material as in force from time to time. This approach to making legislative instruments is justified by the need to preserve consistency with the latest international standards and developments, as these change. For example, requirements for the evaluation of pesticide residues data in manuals published by the Food and Agriculture Organization of the United Nations (Joint FAO/WHO Meeting on Pesticide Residues).

Accredited persons would possess the particular expertise and knowledge necessary for conducting assessments related to the approval of agvet chemicals. These persons would therefore be familiar with changes to international standards and APVMA standards, as and when these occur. Where possible, the material to be incorporated in standards would be available without a fee (published on the APVMA website). It is anticipated that the APVMA would advise accredited persons when standards are amended so that accredited persons are aware of the particular standards that apply. This will ensure that accredited persons are aware of their obligations.

This approach is consistent with the approach used for other chemicals regulation (i.e. human therapeutic and industrial chemical legislation).

Offences and civil penalties

New subsection 6G(4) provides that the regulations may prescribe penalties for offences against the regulations in relation to an accredited person’s contravention of a condition of accreditation or other requirement. These conditions and other requirements would be in the disallowable legislative instrument the APVMA may make under subsection 6G(1).

Consistent with the Guide to Framing Commonwealth Offences the penalty units for these offences cannot be more than 50 penalty units. This limit is also consistent with the current limit for penalties that may be prescribed for offences against the regulations in paragraph 6(2)(i) of the Code Act. New subsection 6G(4) also provides for provisions of the regulations to be declared as civil penalty provisions, to provide for civil proceedings for contravening a condition of accreditation or other requirement.

These provisions are necessary because the disallowable legislative instrument made by the APVMA under subsection 6G(1) (for the accreditation of persons) will not prescribe penalties for offences, or civil penalty provisions, for contravening conditions of accreditation or other requirements. It is therefore anticipated that the regulations would prescribe these offences and civil penalty provisions.

Conditions of accreditation may include specific requirements for technical assessments of agvet chemicals, including formats for the presentation of these assessments or assessment requirements for particular kinds of chemical products or active constituents. It is not appropriate that this level of technical detail be included in the Agvet Code. In addition, these requirements are subject to change, as scientific assessment evolves. The only practical means for applying these requirements is through regulations, and the conditions of accreditation and other requirements in the disallowable legislative instrument the APVMA may make under subsection 6G(1).

Accreditation would not be mandatory-the requirements only relate to particular persons who voluntarily apply to be accredited under the scheme (not the general public). Persons eligible for accreditation would possess the particular expertise and knowledge necessary for conducting assessments related to the approval of agvet chemicals. These persons would therefore be familiar with technical requirements for assessing agvet chemicals and the kinds of conditions and other requirements that would apply to persons that assess information about agvet chemicals.

The ability to prescribe offences and civil penalty provisions is necessary to ensure that the APVMA can respond proportionately where an accredited person contravenes the conditions of accreditation or other accreditation requirements. These sanctions would be in addition to administrative sanctions the APVMA may consider imposing where an accredited person contravenes conditions of accreditation or other accreditation requirements (for example, suspension or cancellation of accreditation). Offences and civil penalty provisions are likely to significantly enhance the effectiveness of the accreditation scheme by encouraging persons to comply with conditions of accreditation and other accreditation requirements, and deter non-compliance.

Both the regulations made under subsection 6G(4) and the instrument the APVMA may make under subsection 6G(1) will be subject to the scrutiny of parliament and disallowance (see section 163A of the Agvet Code). The regulations and the instrument the APVMA may make under subsection 6G(1) must be registered on the Federal Register of Legislative Instruments. These safeguards ensure parliamentary review and that conditions of accreditation and other requirements are readily obtainable.

Item 44 and 45           Section 155 (heading) and subsections 155(1), (2) and (3) of the Code set out in the Schedule

Item 44 amends the heading of section 155 and item 45 amends subsections 155(1), (2) and (3) of the Agvet Code to include references to an instrument made under section 6G of the Agvet Code (item 43). Similar to things that are currently done under the Agvet Code and the Code Regulations, this amendment ensures that if things done under the section 6G instrument would discharge an obligation then this obligation is discharged and that things done under the section 6G instrument may be done anywhere in Australia.

Item 46           Subsections 162(1) and (9) of the Code set out in the Schedule

Item 46 amends subsection 162(1) and (9) of the Agvet Code to provide that the obligations for handling confidential commercial information apply to accredited persons in the same way as they currently apply to other persons that handle this information. The purpose of this measure is to ensure accredited persons handle confidential commercial information appropriately. This obligation is the same obligation that applies APVMA staff and other persons that handle confidential commercial information given to the APVMA. While item 46 engages the right to freedom of expression for accredited persons, it is compatible with the right to freedom of expression provided for in Article 19(2) of the International Covenant on Civil and Political Rights (ICCPR) because it is for the legitimate and well-recognised need to respect the rights of other persons that generated confidential commercial information.

Item 47           At the end of subsection 164(1) of the Code set out in the Schedule

Item 47 amends subsection 164(1) of the Agvet Code to provide for regulations to prescribe, or prescribe a method of working out, fees for matters in the instrument made under section 6G, including waiving or refunding fees. This will support any future implementation of cost recovery for the accreditation scheme.



 

PART 6—VOLUNTARY RECALLS

Overview

Part 6 of Schedule 1 to the Bill amends the Agvet Code to require persons to inform the APVMA when they are undertaking certain voluntary recalls and requires the APVMA to publish such recalls. This person need not be the holder of an approval or registration, as there are a number of different points in the supply chain of a chemical product where a voluntary recall may occur.

Part 6 of the Agvet Code provides for the APVMA to issue recall notices for chemical products (compulsory recalls). These provisions provide for industry to recall products but also provide for the APVMA to issue notices to require persons who have, or have had, stocks of chemical products in their possession to stop supplying the products or to take action in relation to the products as directed by the APVMA. Part 6 of the Agvet Code also clarifies that this power is in addition to those powers conferred on the Australian Competition and Consumer Commission under the Competition and Consumer Act 2010 .

The APVMA receives some notifications from industry about voluntary recalls and may, at its discretion, publish this information on its website. However, the Agvet Code does not currently specify notification and publication requirements if an agvet chemical product is being voluntarily recalled. As a result, it is left to the person recalling the product to determine how the recall is conducted and how stakeholders are notified.

The measures in the Bill will ensure that the APVMA must be informed if certain voluntary recalls are being conducted, where these relate to the matters set out in sections 5A to 5D of the Agvet Code (that is, the safety, efficacy, trade and labelling criteria). The APVMA will then be required to publish such recalls. This will improve transparency and ensure a baseline of information is available to all stakeholders.

Agricultural and Veterinary Chemicals Code Act 1994

Items 48 and 49         Section 100 of the Code set out in the Schedule

Items 48 and 49 amend section 100 of the Agvet Code, which is the explanation section for Part 6 of the Agvet Code (Part 6 deals with recall notices the APVMA may issue). These amendments will insert a new subsection 100(2) to inform readers of the Agvet Code that section 106 (as amended by the Bill) specifies requirements for voluntary recalls of chemical products. These amendments are editorial only and ensure the explanation of Part 6 of the Agvet Code includes the new voluntary recall requirements inserted by the Bill.

Item 50           Section 106 of the Code set out in the Schedule

Item 50 replaces the existing section 106 of the Agvet Code with a new section that will improve the transparency about voluntary recalls of certain chemical products. Notably, the term ‘recall’ has its common meaning and the reasons for recall are not limited to issues relating to human safety.

New subsection 106(1) sets out that section 106 applies if a person (who does not need to be the holder of registration) voluntarily proposes to take action to recall a chemical product because it appears to the person that:

·            the chemical product does not meet the safety, trade or efficacy criteria, or the label does not meet the labelling criteria; or

·            the chemical product is not a registered chemical product (for example, where the concentration, composition or purity of constituents in a batch of the chemical product vary by more than the prescribed extent set out in the Register of Chemical Products).

Section 106 does not apply if a person is recalling a chemical product for a reason that is not set out in subsection 106(1) (e.g. not commercially viable, passed expiry date).

If a person is recalling a chemical product for a reason set out in subsection 106(1) then new subsection 106(2) requires the person to notify the APVMA within two days of this recall in an approved form. The approved form will be a form that the APVMA has approved or a form prescribed in the regulations. It is anticipated the approved form would require a description of the reasons for the recall. Requiring publication of notices according to prescribed criteria reflects the approach used in Australia for food safety recalls.

New subsection 106(3) provides that the regulations may prescribe circumstances where a person does not need to notify the APVMA of the voluntary recall of a chemical product i.e. subsection 106(2) will not apply. An example might include where a product has not yet been supplied to users.

Strict liability offence

New subsection 106(4) makes it an offence of strict liability for a person to fail, or refuse, to notify the APVMA of certain recalls of chemical products (where required to under subsection 106(2)). An applicable pecuniary penalty of 60 penalty units applies as 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 subsection 106(4) of the Agvet Code will be 300 penalty units, due to the application of subsection 170(5) of the Agvet Code.

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.

Prescribing the conduct in new subsection 106(4) of the Agvet Code as an offence of strict liability will place persons on notice to guard against the possibility of any contravention of the Agvet Code by encouraging persons voluntarily recalling certain chemical products for the reasons set out in subsection 106(1) to notify the APVMA of the recall. It is appropriate for these elements to be strict liability because persons engaged in voluntarily recalling chemical products should know their legal obligations before supplying these products and because the offence is necessary to ensure the integrity of the regulatory scheme. This builds on section 9.3 of the Criminal Code to put beyond doubt that ignorance of the law is not a ground on which a person may escape liability. Notifying the APVMA about certain voluntary recalls of chemical products is essential to ensure the regulator is appropriately informed of actions being taken to remove products from the market and to monitor any public health and environment risks and ensure these are managed through the recall.

Further, the proposed penalty in new subsection 106(4) is consistent with the Guide to Framing Commonwealth Offences, which provides that 50 to 60 penalty units is a comparable penalty for the failure to lodge a return or report. A penalty in the upper range of 60 penalty units is considered appropriate given the potential risks to public safety, the environment, animal and plant health or trade that could be relevant or are being managed by the recall of a chemical product.

Civil penalty provision

New subsection 106(5) of the Agvet Code provides that new subsection 106(2) of the Agvet Code is also a civil penalty provision. A note at the end of new subsection 106(5) of the Agvet Code directs 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.

Existing 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.

Existing 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.

Existing 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 subsection 106(4) 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 106(4) of the Agvet Code will be 300 penalty units.

By virtue of section 145AA of the Agvet Code, the civil pecuniary penalty for new subsection 106(5) of the Agvet Code will be 180 penalty units for individuals and 1,500 penalty units for bodies corporate.

This provides a necessary and proportionate deterrent to non-compliance with the requirement to provide a notice about certain recalls of chemical products and reflects 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 not appropriately recalled and monitored by the regulator.

APVMA publication of recalls

New subsection 106(6) provides that where the APVMA is notified of a voluntary recall under new subsection 106(2) then it must publish a copy of the notice about this voluntary recall on its website within three working days and in the Gazette within 14 days, this does not prevent the APVMA from also publishing the recall in any other manner it thinks appropriate. These measures will allow stakeholders to be informed of the recall and will promote the effectiveness of the recall.

New subsection 106(7) provides that the publication requirements in new subsection 106(6) do not apply in circumstances prescribed by the regulations. The effect of this measure is to allow the regulations to prescribe circumstances where the APVMA needs to be informed of a recall but does not need to publish the recall (e.g. product hasn’t been distributed to users through the retail chain). There is no value in publicising these kinds of recalls, as the products have only been distributed to a limited range of persons. It is more efficient to contact these persons directly rather than publicise the recalls of the relevant chemical products.

No limitation on obligations under Australian Consumer Law

New subsection 106(8) clarifies that the voluntary recall requirements under section 106(1) to (8) of the Agvet Code do not limit section 128 of Schedule 2 to the Competition and Consumer Act 2010 (about voluntary recall of consumer goods). This reflects the existing section 106 of the Agvet Code.

Item 51           Application provision

Item 51 provides that the amendments made by Part 6 of Schedule 1 to the Bill will apply in relation to recalls on or after the commencement of Part 6 of Schedule 1 to the Bill and will not apply retrospectively.

Part 6 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 6 of Schedule 1 to the Bill is necessary to ensure the APVMA has sufficient time to appropriately implement changes to policies, procedures and training protocols as a result of the amendments and industry is informed of the changes.



 

PART 7—NOTIFICATION OF NEW INFORMATION

Overview

Part 7 of Schedule 1 to the Bill amends the Agvet Code to ensure that obligations to provide relevant information to the APVMA apply to holders of label approvals, and applicants for both label approvals and variations to approvals or registrations; as they do in relation to holders of active constituent approvals and product registrations under sections 160A and 161 of the Agvet Code.

Currently, information is ‘relevant information’ if it shows the active constituent or product may not meet the statutory criteria, or if it contradicts information in the application or information the APVMA has recorded in the record or the register.

Section 160A of the Agvet Code applies to applications lodged with the APVMA for:

·            approval of an active constituent

·            registration of a chemical product

·            issue of a permit in respect of an active constituent or chemical product

·            issue of a licence in respect of the manufacture of a chemical product.

Section 161 applies to holders of an approval for an active constituent, registration of a chemical product and existing permits in relation to an active constituent or chemical product. These provisions are intended to ensure the regulator is aware of the latest information that is available and provide safeguards to protect public, animal and plant health and the environment from potential damage where new information about an agvet chemical comes to light. This addresses a gap in the current requirements in sections 160A and 161 (to provide relevant information) as they do not apply to an applicant for approval of a label for containers for a chemical product nor to applicants seeking to vary an approval or registration.

Agricultural and Veterinary Chemicals Code Act 1994

Items 52 and 53         Paragraph 160A(1)(a) of the Code set out in the Schedule

Items 52 and 53 amend paragraph 160A(1)(a) of the Agvet Code to insert new subparagraphs 160A(1)(a)(vi) and (vii), with a consequential minor change to 160(1)(a)(v). Section 160A of the Agvet Code currently deals with requiring applicants for approval of an active constituent and registration of a chemical product to provide relevant information to the APVMA. The amendments extend the scope of applicants that must inform the APVMA of relevant information about their application. The amendments mean the following applicants must also provide relevant information to the APVMA:

·            applicants for approval of a label for containers for a chemical product

·            applicants for variations of approvals or registrations.

Relevant information is information that contradicts any information that was given in the application and relates to the relevant particulars (set out in paragraphs 19(c) or 20(1)(c) of the Agvet Code), as well as information that shows the constituent or product may not meet the safety criteria, trade criteria or efficacy criteria.

Item 54           Paragraph 160A(1)(c) of the Code set out in the Schedule

Item 54 amends paragraph 160A(1)(c) of the Agvet Code to insert references to the label of a chemical product. This amendment is necessary to complement the amendments in item 53, which extends the scope of applicants that must inform the APVMA of new relevant information about their application.

Items 55 and 56         Paragraphs 160A(4)(a) and (b) of the Code set out in the Schedule

Items 55 and 56 amend paragraphs 160A(4)(a) and (b) of the Agvet Code to insert references to instructions and particulars on an approved label and labelling criteria. The amendment will extend the meaning of ‘relevant information’ in section 160A so that it includes information about these label-related matters. These amendments are necessary to give full effect to the amendments in item 53.

Item 55 amends subparagraph 160A(4)(a)(ii) of the Agvet Code to include a reference to the relevant particulars for a label approval. The purpose of this amendment is to require an applicant for label approval to provide information to the APVMA if they become aware of information in their application that contradicts information relating to the matters prescribed for subparagraphs 21(c)(iv) or (iva) of the Agvet Code (instructions and particulars on an approved label, including any particulars prescribed by regulations). This would include information that contradicts information relating to the name of the active constituent or product, or the signal words that are required in a label by the current Poisons Standard.

Item 56 amends subparagraph 160A(4)(b) of the Agvet Code to refer to where the label may not meet the labelling criteria. The purpose of this amendment is to require an applicant for label approval to provide information to the APVMA if they become aware of information that shows the label may not meet the labelling criteria.

The amendments made by items 55 and 56 will ensure the APVMA remains informed of the latest available information for an application for label approval and can take the appropriate action to respond to that information.

Item 57           After paragraph 161(1)(b) of the Code set out in the Schedule

Items 57 inserts new paragraph 161(1)(c). Section 161 currently deals with requiring holders of approval of active constituents and registrations of chemical products to provide relevant information to the APVMA. The amendment extends the scope of holders that must inform the APVMA of relevant information to include the holder of the approval of a label for containers for a chemical product.

Currently, relevant information is information that contradicts any information entered in the record or register or record of permits or information that shows the constituent or product may not meet the safety criteria, trade criteria or efficacy criteria.

The amendment means that holders of the approval of a label for containers for a chemical product will have the same obligations to provide relevant information about their approval as currently applies for other holders. The amendment will ensure the APVMA remains informed of the latest available information and can take the appropriate action to respond to any new relevant information.

Item 58           Subsection 161(1) of the Code set out in the Schedule

Item 58 amends subsection 161(1) of the Agvet Code to insert references to the label of a chemical product. This amendment is necessary to complement the amendment in item 57, which extends the scope of holders that must inform the APVMA of relevant information to include holders of approval of a label for containers of a chemical product.

Item 59           Subsection 161(2) of the Code set out in the Schedule

Item 59 is an editorial amendment to replace the current unbolded text of ‘relevant information’ with bolded italicised text of ‘relevant information’. This aligns with the approach used in section 160A. This amendment has no other effect.

Items 60 and 61         Subsection 161(2) of the Code set out in the Schedule

Items 60 and 61 amend subsection 161(2) of the Agvet Code to insert references to label matters and labelling criteria. These amendments are necessary to give full effect to the amendment in item 57, so that the relevant information that must be given to the APVMA includes information about matters relating to labels.

Item 60 amends subsection 161(2) of the Agvet Code to include a reference to the relevant APVMA file for the label. The purpose of this amendment is to require a holder of a label approval to provide information to the APVMA if they become aware of information that contradicts information in the relevant APVMA file for the label.

Item 61 amends paragraph 161(2)(b) of the Agvet Code to expand the definition of relevant information to incorporate information that shows the label may not meet the labelling criteria. The purpose of this amendment is to require a holder of a label approval to provide information to the APVMA if they become aware of information that shows the label may not meet the labelling criteria.

Item 62           Application provisions

Item 62 provides that the amendments made by Part 7 of Schedule 1 to the Bill will apply in relation to applications lodged on or after the commencement of the amendments. This ensures that the obligations on applicants do not apply retrospectively to applications that have already been lodged with the APVMA. Item 62 also provides that the amendments made by Part 7 of Schedule 1 to the Bill will apply in relation to information a holder becomes aware of after commencement of the amendments. This ensures that the obligations on holders do not apply retrospectively.

Part 7 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 7 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 and industry is informed of the new requirements.



 

PART 8—DEFINITION OF REGISTERED CHEMICAL PRODUCT

Overview

Part 8 of Schedule 1 to the Bill amends the Agvet Code definition of a registered chemical product so it is consistent with variations authorised under section 83 of the Agvet Code.

Section 83 of the Agvet Code already provides for the regulations to prescribe, among other things, concentration ranges for constituents in chemical products (‘constituent’ is defined in section 3 of the Agvet Code and includes both active and non-active constituents). This, for example, allows for the routine variations in constituent concentration arising in manufacturing to be prescribed. However, offences and civil penalty provisions in Part 4 of the Agvet Code operate such that a product cannot be supplied if it is formulated differently to the ‘registered’ formulation (therefore, the concentration of the constituents in a product must match that in the register). Thus, there is an anomaly in the Agvet Code in that, for the offences and civil penalty provisions in Part 4, the chemical product formulation must align exactly with the concentrations of constituents in the register, irrespective of any variation in constituent concentration that is provided for by the regulations made for section 83.

This inconsistency places an unreasonable burden on the APVMA and industry because the only means to address this would be through holders making applications to the APVMA to include more detail about a product’s composition in the register. The regulatory effort associated with this task is inconsistent with the risks, particularly given that some provisions of the Agvet Code already provide for these reasonable variations in a product’s composition.

The amendments in the Bill will address these inconsistencies by providing, through the definition of registered chemical product, for prescribed standards for the concentration range of constituents, the kinds of constituents, and the composition and purity of constituents in chemical products to apply for all offences and civil penalty provisions in the Agvet Code.

It is not intended that the amendments would allow for fundamental changes in a product’s composition which would continue to require a variation application to the APVMA.

Agricultural and Veterinary Chemicals Code Act 1994

Item 63           Section 3 of the Code set out in the Schedule

Item 63 inserts a new provision in section 3 of the Agvet Code to refer to a new definition of ‘registered chemical product’ in section 5AA (as inserted by item 64).

Item 64           After section 5 of the Code set out in the Schedule

Item 64 inserts a new definition of a ‘registered chemical product’ at new section 5AA of the Agvet Code. This extends the scope of what constitutes a registered chemical product under the Agvet Code to reflect the variations in a product’s composition that are authorised by regulations made for section 83 of the Agvet Code.

Section 83 of the Agvet Code effectively provides for reasonable variations in a product’s composition, such as those that reflect manufacturing processes for chemical products. Specifically, it provides that the following may vary within certain limits that are prescribed in regulations:

·            a chemical product’s constituents

·            the concentration of each constituent in the product

·            the composition and purity of each constituent in the product.

Currently, regulation 41 of the Code Regulations sets out the variations prescribed for the purpose of section 83.

However, the variations prescribed for section 83 do not extend to other provisions in the Agvet Code, including the offences and civil penalty provisions in sections 75 and 78 (which relate to possessing with the intention of supply, or supplying an unregistered chemical product). This results in an inconsistency where, although some provisions allow for reasonable variations in a product’s composition, others do not.

The new definition addresses this inconsistency. This will reduce the burden on the APVMA and industry. Holders will no longer need to apply to the APVMA to amend the relevant particulars of their registration, as the reasonable variations in a product’s composition could be prescribed in the regulations and there would be no need for the register to include these details for each chemical product.

Like the current definition of registered chemical product, the definition in new section 5AA continues to provide that a registered chemical product includes a chemical product that is registered by the APVMA and complies with the relevant particulars for that registration in the register. However, the new definition extends the scope of the current definition so that a registered chemical product includes where a product varies within the extent (i.e. the range) of:

·            the constituents prescribed in regulations made for paragraph 83(1)(a) of the Agvet Code (subsection 5AA(2))

·            the concentration of each constituent prescribed in regulations made for paragraph 83(1)(b) of the Agvet Code (subsection 5AA(3))

·            the composition of each constituent prescribed in regulations made for paragraph 83(1)(c) of the Agvet Code (subsection 5AA(4))

·            the purity of each constituent prescribed in regulations made for paragraph 83(1)(c) of the Agvet Code (subsection 5AA(5)).

New subsection 5AA(1) is the general rule that specifies the requirements for the relevant particulars of a chemical product registration. New subsections 5AA(2) to (5) modify that rule so as to extend the scope of these requirements but only if:

·            there are regulations made to extend the scope; and

·            the particulars are within the scope prescribed in the regulations made for section 83.

For example, where the register specifies a product must contain 100 g/kg of a constituent then that is precisely what the chemical product must contain unless provided for in a regulation made under subsection 83(3) of the Agvet Code. However, if the regulations prescribe that the constituents in a chemical product must not differ by more than six per cent of the concentration in the register, then the chemical product would be allowed to contain between 94 g/kg and 106 g/kg of the constituent and still remain a registered chemical product for the purposes of the Agvet Code.



 

PART 9—SUSPENSION OR CANCELLATION OF APPROVAL OR REGISTRATION FOR PROVISION OF FALSE OR MISLEADING INFORMATION

Overview

Part 9 of Schedule 1 to the Bill introduces more comprehensive grounds for suspending or cancelling approvals or registrations where information is provided that is false or misleading in a material particular.

Section 38A of the Agvet Code provides for the APVMA to suspend or cancel an active constituent approval or product registration where false or misleading information has been provided. However, section 38A does not currently apply if the false or misleading information was provided:

·            in an application for variation of an approval of an active constituent or variation of a registration of a chemical product

·            in an application for approval, or variation of an approval, of a label for containers for a chemical product

·            by a person other than the holder, such as through subsection 27(2) of the Agvet Code.

New section 38A addresses these deficiencies and improves the capability of the APVMA to respond to false or misleading information after a product has been registered or a label or active constituent has been approved. Specifically, it broadens the circumstances where a more proportionate APVMA response (suspension or cancellation) is available, rather than the APVMA only being able to rely on the offences and civil penalty provisions in section 146 of the Agvet Code for providing false or misleading information.

The amendments do not affect the existing requirement (section 34P of the Agvet Code) for the APVMA to provide the holder with a notice of reasons for a proposed decision under section 38A and invite (and consider) submissions from the holder. Decisions under section 38A will also continue to be subject to internal review by the APVMA (section 166 of the Agvet Code) and merits review by the AAT (section 167 of the Agvet Code).

Agricultural and Veterinary Chemicals Code Act 1994

Item 65           Paragraph 34N(4)(d) of the Code set out in the Schedule

Item 65 amends section 34N of the Agvet Code so that the explanation section for suspensions and cancellations refers to persons instead of holders. This is a consequential amendment arising from item 66.

Item 66           Section 38A of the Code set out in the Schedule

Item 66 replaces section 38A of the Agvet Code so that the APVMA may suspend or cancel an approval or registration if any person has given information that was false or misleading in a material particular in relation to any of the following:

·            an application for approval or registration (including for the new approval of a prescribed active constituent or registration of a prescribed chemical product provided for in Part 1 of Schedule 1 to the Bill)

·            an application for a variation of an approval or registration (which also applies to a notice of a notifiable variation under Division 2AA of Part 2 of the Agvet Code and an application for a prescribed variation under Division 2A of Part 2 of the Agvet Code)

·            in response to notices to provide information (under subsection 32(1) or section 33 or 159 of the Agvet Code)

·            new information that comes to light, either before or after, the APVMA has made an approval or registration decision as required by sections 160A or 161 of the Agvet Code, such as information that shows that a product or active constituent may not meet the safety criteria.

The amendments will complement the existing powers the APVMA has to consider suspending or cancelling an approval of an active constituent or registration of a chemical product if a holder provides information that is false or misleading in a material particular. This will improve the post-registration response capability of the APVMA.

The power of the APVMA to suspend or cancel an approval or registration remains subject to a notice issued under section 34P of the Agvet Code. Section 34P provides that before making a decision to suspend or cancel an approval or registration, the APVMA must notify the holder of its proposed decision, setting out its reasons. It must also invite submissions from the holder about the proposed suspension or cancellation, and have regard to these submissions before making a decision.

New section 38A also applies to information given by any person—extending the scope of the current powers which only apply to the holder of an approval or registration. As a result, there is the potential for persons other than holders (for example, persons providing information on behalf of the holder) to provide false or misleading information to the APVMA and for this information to impact on holders of approval or registration i.e. by triggering a suspension or cancellation. The potential for this ‘mischief’ is low and can be managed through any notices to the holder under section 159 and 34P of the Agvet Code. This provides the holder with the opportunity to address any issues with the relevant information and ensures that there are safeguards to mitigate the potential for any ‘mischief’ from other persons providing false or misleading information. The potential for mischief is also minimised by the existing constraints on who can submit information.

Decisions made under section 38A are subject to internal review by the APVMA (section 166 of the Agvet Code) and merits review by the AAT (section 167 of the Agvet Code). This will further ensure that there are safeguards in place to provide that the correct and preferable decision is made.

Item 67           Application provision

Item 67 provides that new section 38A only applies in relation to information given on or after the commencement of Part 9 of Schedule 1 to the Bill. Part 9 of Schedule 1 to the Bill commences on the day after the Bill receives the Royal Assent. This application provision ensures that there is no retrospective application of new section 38A.

PART 10—SUPPLY OF REGISTERED CHEMICAL PRODUCTS WITH UNAPPROVED LABEL

Overview

Part 10 of Schedule 1 to the Bill addresses an inconsistency in the Agvet Code by clarifying what information must be included in a label .

The current section 81 of the Agvet Code requires that the label attached to the container for a chemical product must state the ‘relevant particulars’. However, it is not appropriate that all relevant particulars should appear on a label. For example, the name of the nominated agent and the holder of approval—as opposed to the marketer of the product—are unnecessary. This inconsistency needs to be addressed as there is a serious criminal offence and a civil penalty provision for not including all ‘relevant particulars’ on a label.

Agricultural and Veterinary Chemicals Code Act 1994

Items 68 to 71             Subsections 81(1) and (2) of the Code set out in the Schedule

Items 68 to 71 amend subsections 81(1) and (2) of the Agvet Code to replace all references to ‘relevant particulars’ with ‘the minimum information’ (defined in new subsection 81(5)—see item 73) when discussing the correct information that must be in a label. The effect of these amendments would be to specify only those minimum information requirements that must be included on a label to reduce the need for inappropriate and unnecessary information. See the Statement of Compatibility with Human Rights for more information about the existing reverse burden defence in subsection 81(2).

Item 72           Paragraphs 81(3)(a), (b) and (c) of the Code set out in the Schedule

Item 72 replaces paragraphs 81(3)(a), (b) and (c) with new paragraphs 81(3)(a), (b), (c) and (d). Subsection 81(3) provides for a registered chemical product to be supplied for a limited period (2 years, or other period as determined by the APVMA) if the information on the label is different from that required when supply occurs, but is information that was required on the label at a time before supply took place.

Information required on a label may change. It is therefore necessary to enable the APVMA to deal with products containing information that was previously required but is different from the information that is currently required (that is, to allow trade out of a product with previously required information in the label). The amendments to subsection 81(3) continue to allow the APVMA to deal with this by allowing a product (with the previously required information in the label) to be supplied, where the APVMA considers that is appropriate. See the Statement of Compatibility with Human Rights for more information about the existing reverse burden exception in subsection 81(3).

Item 73           At the end of section 81 of the Code set out in the Schedule

Item 73 inserts new subsection 81(5) into the Agvet Code to specify what ‘minimum information’ means for the purposes of section 81. Minimum information is the information covered by subparagraphs 21(c)(iii) and (iv) of the Agvet Code (the distinguishing number, instructions and particulars that are to be contained on a label). These particulars can include matters such as any signal heading required by a constituent’s poisons scheduling and the name of the product.

Item 74           Application provision

Item 74 provides that the amended requirements in Part 10 of Schedule 1 would only apply to supplies occurring on or after the commencement of Part 10, to avoid retrospective application. Part 10 of Schedule 1 to the Bill will commence on the day after the Bill receives the Royal Assent.

PART 11—VARIATION OF APPROVAL OR REGISTRATION DURING SUSPENSION

Overview

Part 11 of Schedule 1 to the Bill amends the Agvet Code to introduce practical measures to deal with suspended registrations and to address the reason for a suspension. It will also allow holders to request a suspension of an approval or registration.

The Bill will allow a holder to apply to vary the relevant particulars and conditions for a product registration that is suspended, provided the application relates to the reasons for the suspension. This will ensure that the issues with a product that led to its suspension can be appropriately rectified prior to revocation of the suspension.

This Part is drafted on the basis that Part 4 of Schedule 1 to the Agricultural and Veterinary Chemicals Legislation Amendment (Operational Efficiency) Bill 2017 will have already commenced-to provide for the variation of relevant particulars and conditions of a label approval that is suspended.

Currently, under Division 5 of Part 2 of the Agvet Code, the APVMA may suspend an approval or registration. 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), 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. However, the APVMA cannot currently amend a product registration to address the problem that led to the requirement to suspend the product registration without first revoking the suspension.

The amendments in the Bill will remedy this unintended administrative barrier to the appropriate rectification of issues with suspended product registrations, which prevents the holder of a registration from dealing with the suspension problem and putting the chemical product back on the market.

In addition, because a holder currently can only request cancellation of their registration, and not suspension, a holder may be placed in a difficult position of having to cancel their registration to deal with administrative matters (for example, an overseas holder arranging a new nominated agent in Australia). The holder then has to re-apply for registration at a later time. This is an unnecessarily restrictive and costly means of dealing with administrative matters.

Agricultural and Veterinary Chemicals Code Act 1994

Items 75 to 77             Section 42 of the Code set out in the Schedule

Items 75 to 77 amend section 42 of the Agvet Code to provide that a holder can request suspension of an approval or registration in addition to the current option of requesting cancellation of an approval or registration. This will enable a holder to have their approval or registration suspended while they deal with any issues with it. It will mean that the holder will not have to cancel their registration or approval to deal with administrative matters and then have to re-apply for registration or approval at a later time.

Item 77 also amends subsection 42(1) to require the APVMA to suspend or cancel an approval or registration where a holder requests either suspension or cancellation and the APVMA is satisfied that there are no valid reasons why it should not agree to the request.

Items 78 to 80             Subsection 43(4) of the Code set out in the Schedule

Items 78 to 80 amend subsection 43(4) of the Agvet Code. These amendments ensure that, despite the suspension of a registration of a chemical product or approval of an active constituent or label, a person is not prevented from lodging a notice, making an application or seeking a variation of the relevant particulars or conditions provided this is relevant to the reasons for the suspension. This amendment will ensure that the issue or issues with a registration or approval that led to its suspension could be appropriately rectified prior to revocation of the suspension. This is the same flexibility provided for in the Agricultural and Veterinary Chemicals Legislation Amendment (Operational Efficiency) Bill 2017, for varying a suspended label approval. While current subsection 47(1) of the Agvet Code already means active constituents can be varied while suspended (since it specifies that an active constituent approval remains in force until cancelled), inclusion of all approvals in amended subsection 43(4) will simplify the legislation.

Item 81           At the end of section 43(5) of the Code set out in the Schedule

Item 81 amends subsection 43(5) of the Agvet Code to ensure that the notice, application or variation appropriately relates to the issue or issues with a registration that led to its suspension. The amendment extends the current scope of subsection 43(5) so that it relates to the matters relevant to the suspension of registration, in addition to the current matters that are relevant for a label approval suspension.

The amendment extends subsection 43(5) to include all approvals and chemical product registrations.

Items 82 and 83         Subsection 45A(4) of the Code set out in the Schedule

Items 82 and 83 are consequential amendments to subsection 45A(4) of the Agvet Code to reflect the amendments made by items 75 to 77. These provide that notices about the suspension of an approval or registration under section 45A do not need to be given to the holder where the holder requests suspension. This aligns with the current approach where notices about cancellation of an approval or registration do not need to be given to the holder where the holder requests cancellation. It is unnecessary for a holder to be notified about these suspensions or cancellations under section 45A because these holders would already have been notified of the suspension or cancellation under subsection 42(2).

Item 84           Application provision

Item 84 provides that the amendments to section 42 of the Agvet Code only apply to requests for suspension of an approval or registration made on or after the commencement of Part 11 of Schedule 1 to the Bill.

Item 84 also provides that amendments to section 43 of the Agvet Code apply to suspensions made on or after commencement and suspensions made before commencement that were in effect immediately before commencement.



 

PART 12—SAFETY, EFFICACY, TRADE AND LABELLING CRITERIA

Overview

Part 12 of Schedule 1 to the Bill amends the Agvet Code to address anomalies in relation to prescribing matters for the labelling criteria and for overseas trials and experiments (including international assessments and data) in relation to the safety, efficacy, trade and labelling criteria.

Under section 5D of the Agvet Code, there is no power for the regulations to prescribe matters the APVMA must have regard to for the purposes of being satisfied that a label meets the labelling criteria. This is inconsistent with the regulation-making powers for the other statutory criteria in sections 5A (safety criteria), 5B (efficacy criteria) and 5C (trade criteria).

Separately, section 160 of the Agvet Code provides the APVMA with the discretion to consider overseas trials and experiments, including international assessments and information. This discretion creates an anomaly in that it means the regulations made under sections 5A to 5C may not be able to prescribe that the APVMA must have regard to overseas trials and experiments. This is because the discretion in primary legislation means the regulations cannot modify this discretion.

Agricultural and Veterinary Chemicals Code Act 1994

Item 85           At the end of subsection 5D(2) of the Code set out in the Schedule

Item 85 amends section 5D of the Agvet Code to allow the regulations to prescribe matters the APVMA must have regard to for the purposes of being satisfied that a label meets the labelling criteria, similar to the current regulation-making powers in sections 5A to 5C of the Agvet Code.

Item 86           After section 5D of the Code set out in the Schedule

Item 86 inserts a new section 5E into the Agvet Code to allow regulations, if necessary in the future, to prescribe that the APVMA must have regard to the matters in section 160 of the Agvet Code.

Item 87           Application provision

To avoid retrospective application, item 87 provides that any matters prescribed in regulations for the labelling criteria only apply after Part 12 commences. Part 12 will commence the day after the Royal Assent.



 

PART 13—ANNUAL OPERATIONAL PLANS

Overview

Part 13 of Schedule 1 to the Bill simplifies the APVMA’s corporate reporting requirements by removing the need for the APVMA to develop and seek approval of an annual operational plan in addition to a corporate plan.

Part 6 of the Administration Act currently includes requirements for the APVMA to prepare an annual operational plan. The annual operational plan sets out the actions the APVMA intends to take to comply with the objectives in the corporate plan in the coming year. It includes any performance indicators that the Chief Executive Officer considers appropriate and any information prescribed by regulations. The plan requires annual ministerial approval.

Section 35 of the Public Governance, Performance and Accountability Act 2013 (PGPA Act) and Part 6 of the Administration Act both require the Chief Executive Officer of the APVMA to prepare a corporate plan. As with the annual operational plan, the corporate plan is prepared annually (but covers four years), and requires ministerial approval. The corporate plan is also presented to the Minister for Finance. Currently, under the PGPA Act, the corporate plan must include the following matters (section 16E of the Public Governance, Performance and Accountability Rule 2014):

·            how the entity will achieve its purposes

·            how the entity’s performance will be measured and assessed, including for the purposes of preparing its annual performance statements

·            the key strategies and plans that the entity will implement in each year covered by the plan to achieve its purposes

·            a summary of the risk oversight and management systems in place for each year of the plan.

Removing the requirement for the APVMA to prepare an annual operational plan would remove duplicative reporting that is required by the PGPA Act.

The PGPA Act also requires the APVMA to report annually on its performance against the corporate plan. Section 61 of the Administration Act requires that this is done in the APVMA’s annual report).

Agricultural and Veterinary Chemicals (Administration) Act 1992

Items 88 and 89         Part 6 (heading) and sections 55, 56 and 57

Items 88 and 89 amend the heading for Part 6 of the Administration Act and omit sections 55, 56 and 57 of the Administration Act to remove the requirement for the APVMA to develop an annual operational plan.

Item 90 to 92                          Paragraphs 61(a), (b) and (d)

Items 90 to 92 make consequential amendments to section 61 (annual report requirements) of the Administration Act to reflect the removal of the annual operational plan.

Item 93           Application and transitional provisions

Item 93 provides that the amendments in Part 13 will apply from the calendar year beginning on 1 January 2020. Repealed sections 55 to 57 and section 61 (unamended) will continue to apply to an annual operational plan for the 12 months from 1 July 2019 to 30 June 2020. Item 93 also provides that any regulations made under paragraph 61(b) prior to commencement of this Part continue in force, so the regulations made for the annual report requirements continue to apply.

PART 14—OTHER AMENDMENTS

Overview

Part 14 of Schedule 1 to the Bill will:

·            amend the Agricultural and Veterinary Chemicals Legislation Amendment Act 2013 ( Amendment Act) to align the review of the Amendment Act with the general review of agvet legislation that is specified under the Administration Act

·            make a number of minor amendments to the Administration Act and the Agvet Code to improve the operation of these laws and remove redundant and unnecessary provisions.

Section 4 of the Amendment Act requires the Minister to provide a report to parliament on the amendments made by that Act within 15 sitting days after 1 July 2019. Separately, section 72 of the Administration Act requires the Minister to ensure that, at least every 10 years, a review is made of the agvet chemical legislation but includes an anomaly that prevents the report from this review being tabled more frequently than 10 yearly intervals. The Bill aligns the timing of the review required under the Amendment Act with that of the review required under the Administration Act. This consolidates the timing of the two reviews and avoids the need for separate and potentially overlapping reviews of agvet legislation.

The Bill also improves the operation of the Administration Act and the Agvet Code by:

·            removing redundant and unnecessary provisions (including unnecessary transitional provisions)

·            clarifying how ‘classes’ of matter are dealt with to ensure consistency with both subsection 33(3A) of the Acts Interpretation Act 1901 and subsection 13(3) of the Legislation Act 2003

·            authorising the APVMA to reconsider (internally review) decisions on its own initiative to improve the ability of the APVMA to respond where errors are made and reduce the onus on other persons to request the APVMA to internally review a decision.

Agricultural and Veterinary Chemicals (Administration) Act 1992

Items 94 and 95         Paragraphs 7(1A)(a) and 8A(2)(a) and (b)

Items 94 and 95 are minor amendments to the Administration Act to align section 7 with the role of the APVMA and to align section 8A with the approach used for applications in the Agvet Code.

Item 96           Subsection 58(7)

Items 96 removes an unnecessary definition of Finance Minister as this is already defined in section 4 of the Administration Act.

Item 97           Subsection 69D(1)

Item 97 will amend section 69D of the Administration Act, which deals with export certificates the APVMA may issue. The amendment clarifies that the fee for export certificates is to be paid to the Commonwealth, like all other fees the APVMA receives.

Item 98 and 101         After subsection 69D(1A) and application provision

Item 98 will also amend section 69D of the Administration Act to provide that the APVMA may, on its own initiative, reconsider a decision to refuse to give an export certificate and must give notice of the outcome of the reconsideration to the person who applied for the certificate. Item 101 provides that the amendments made by item 98 only apply to decisions made after commencement, to avoid retrospective application of the amendments. These measures allow the APVMA to deal with errors without a person having to apply to have a decision reconsidered.

Item 99           Subsection 72(5)

Item 99 will amend subsection 72(5) of the Administration Act to provide that the review of agvet legislation in section 72 of the Administration Act may be tabled before the 10 year anniversary of the commencement of that section. This addresses an anomaly in section 72 whereby, although subsection 72(1) requires that the minister ensures a review of the agvet legislation is required at least every 10 years, subsection 72(5) prevents this review report from being tabled until after 10 years have passed. The amendment provides flexibility around when the review can be tabled, consistent with the timing for the conduct of the review under existing subsection 72(1).

Item 100         Sections 78, 79 and 80

Item 100 will repeal sections 78, 79 and 80 of the Administration Act as these transitional provisions (from commencement of the Administration Act in 1993) are no longer necessary.

Agricultural and Veterinary Chemicals Code Act 1994

Item 102         After section 6E of the Code set out in the Schedule

Item 102 will insert a new section 6F into the Agvet Code to make it clear that references to a kind of matter or thing includes classes of matter or things (particularly relevant to matters such as substances, chemical products, constituents or labels) consistent with the approach provided for in the Acts Interpretation Act 1901 and the Legislation Act 2003 .

Item 103         Subparagraph 14A(1)(a)(ii) of the Code set out in the Schedule

Item 103 will correct the spelling of the ‘United States Pharmacopeia’ in subparagraph 14A(1)(a)(ii).

Items 104 to 127 and 130      Sections 74, 75, 76, 78 and 167 of the Code set out in the Schedule

Items 104 to 127 and 130 will remove unnecessary provisions for exceptions and determinations that the APVMA could make about approvals and registrations that had ceased under sections 74, 75, 76 and 78. These provisions have never been used by the APVMA and provide for the APVMA to authorise the supply, possession and custody of active constituents and products after the approval or registration has ceased. The APVMA has not needed these provisions as its existing powers to issue permits or exemptions have been sufficient to deal with any supply, possession or custody authorisations needed after an approval or registration has ceased.

Items 128, 129 and 132         Section 166 of the Code set out in the Schedule and application provision

Items 128 and 129 will provide for the APVMA to, on its own initiative, reconsider a decision under the Agvet Code or regulations. This includes a requirement to give a notice of the outcome of the reconsideration to the relevant persons (new subsection 166(4B)). To avoid retrospective application, item 132 would provide that these amendments only apply to original decisions made after commencement.

Under section 166 of the Agvet Code a person can request the APVMA to reconsider a decision the APVMA has made under the Agvet Code. These are known as ‘internal reviews’. However, the APVMA cannot currently internally review a decision on its own initiative. This reduces the ability of the APVMA to respond where errors are made and places the onus on other persons to request the APVMA to internally review a decision. These amendments make it easier for the APVMA to deal with any errors in decisions and not have to rely on other persons requesting reconsiderations of decisions.

Item 131         Sections 180, 183 and 184 of the Code set out in the Schedule

Item 131 will repeal three transitional provisions in the Agvet Code that are no longer necessary. The transitional provisions that dealt with reconsiderations (chemical reviews), pending AAT proceedings and notices for information from before the commencement of the Agvet Code in 1995 are no longer necessary.

Agricultural and Veterinary Chemicals Legislation Amendment Act 2013

Item 133         Subsection 4(4)

Item 133 amends the review of the Amendment Act so that the Minister is required to provide a report to parliament on the amendments made by that Act within 15 sitting days after 1 July 2024 (instead of after 1 July 2019). This will align the timing of the review of the Amendment Act with the review provided for in section 72 of the Administration Act (which requires the Minister to ensure that, at least every 10 years, a review is made of the agvet chemical legislation).

This amendment provides for the two reviews to potentially be consolidated into a single review. This will avoid the need for separate and potentially overlapping reviews of agvet legislation.



 

SCHEDULE 2—PARTS 1 AND 2—OTHER AMENDMENTS

Overview

Parts 1 and 2 of Schedule 2 to the Bill operates to include agvet chemical-related matters from the Agriculture and Water Resources Legislation Amendment Bill 2016 (the Omnibus Bill) in this Bill. This is considered appropriate given the agvet chemical focus of this Bill. These matters are:

·            amendments which would simplify notices provided by the APVMA to Food Standards Australia New Zealand (FSANZ) under section 8E of the Agvet Code

·            amendments to paragraph 117A(1)(a) of the Agvet Code so that it refers to where the APVMA proposes ‘to suspend or cancel a permit’ rather than an ‘approval or registration’ (‘approval or registration’ is an error)

·            repealing the Removing Re-approval and Re-registration Act.

Agricultural and Veterinary Chemicals Code Act 1994

Items 1 and 3                         Subparagraph 8E(2)(b)(i) of the Code set out in the Schedule

Item 1 amends subparagraph 8E(2)(b)(i) to simplify the notice requirements for notices provided to FSANZ, while still ensuring these notices include the information that FSANZ requires (specifically the names, or proposed names, of the active constituents concerned). This reflects the information already required to be recorded in the Maximum Residue Limit Standard (Standard 1.4.2 of the Australia New Zealand Food Standards Code).

Item 3 provides that the amendment made by item 1 only applies to notices given after item 1 commences, to avoid retrospective application.

Item 2             Paragraph 117A (1)(a) of the Code set out in the Schedule

Item 2 corrects an error in paragraph 117A(1)(a) of the Agvet Code so that it refers to where the APVMA proposes ‘to suspend or cancel a permit’ rather than an ‘approval or registration’ (‘approval or registration’ is an error).

Agricultural and Veterinary Chemicals Legislation Amendment (Removing Re-approval and Re-registration) Act 2014

Item 4             Whole of the Act

Item 4 repeals the Agricultural and Veterinary Chemicals Legislation Amendment (Removing Re-approval and Re-registration) Act 2014 , as all the transitional provisions for this Act are no longer required.



 

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 (Streamlining Regulation) Bill 2018

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 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 Chemicals Legislation Amendment Act 2013 (the Amendment Act). The Bill also repeals the Agricultural and Veterinary Chemicals Legislation Amendment (Removing Re-approval and Re-registration) Act 2014 (the Removing Re-approval and Re-registration Act).

The Bill will improve the effectiveness and efficiency of the national system for regulating agricultural and veterinary (agvet) chemical products. The Bill will:

·            enable the use of new, simpler regulatory processes for low risk chemical products (to simplify the approval of active constituents and labels, and the registration of certain products)

·            provide the Australian Pesticides and Veterinary Medicines Authority (APVMA) and industry with more flexibility to deal with certain types of new information provided when the APVMA is considering an application

·            provide for extensions to limitation periods and protection periods as an incentive for chemical companies to register certain new uses of chemical products—particularly those uses (minor uses) with insufficient commercial return for chemical companies to normally add to the product label

·            support computerised decision-making by the APVMA

·            provide for a legislative instrument made by the APVMA to prescribe a scheme in the future that would allow applicants and the APVMA to use accredited third party providers to undertake assessment services

·            optimise risk communication about chemical products by improving the transparency of voluntary recalls

·            harmonise the need to inform the APVMA of new information (where it relates to the safety criteria) so that the same obligations apply to all holders and applicants

·            provide a more practical mechanism for dealing with minor variations in the constituents in a product, that normally occur in the manufacturing process

·            provide the APVMA with more proportionate options for dealing with false or misleading information, and clarify what information must be included on a label

·            allow the holder of a suspended product to address the reason for the suspension

·            fix anomalies in the regulation-making powers for the labelling criteria

·            simplify the APVMA’s corporate reporting requirements

·            make minor and machinery changes including removal of unnecessary and redundant provisions.

Human rights implications

Some parts of the Bill engage, or have the potential to engage, Articles 14, 15, 17 and 19 of the International Covenant on Civil and Political Rights (ICCPR). These are identified and assessed below for each part of the Bill.

Part 1 of Schedule 1—Approval and registration for prescribed active constituents, chemical products or labels

Part 1 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 2 of Schedule 1—Information to be taken into account in determining applications

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—Limits on use of information

Part 3 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 4 of Schedule 1—Computerised decision-making

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.

While Part 4 includes measures to allow the APVMA to substitute decisions made by a computer, these measures do not affect a person’s right to an effective remedy, as there is no change to the circumstances in which a person may request an internal review or apply for AAT review.

Part 5 of Schedule 1—Accreditation of assessors

Part 5 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.

Right to freedom of expression

Item 46 in Part 5 of Schedule 1 to the Bill extends the existing secrecy provisions in section 162 of the Agvet Code to a new class of persons, namely ‘accredited persons’. As such, a current or past accredited person would be prohibited from disclosing ‘any information about an active constituent for a proposed or existing chemical product, about a chemical product or any of its constituents, or about a label for containers for a chemical product’ if:

·            the person knows that the information is ‘confidential commercial information’ (as that term is defined in section 3 of the Agvet Code)

·            the information was acquired by the person in the performance of their role as an accredited person.

This restriction to the disclosure of confidential commercial information engages the right to freedom of expression, recognised in Article 19(2) of the ICCPR. Article 19(3)(a) recognises that the exercise of this right may be subject to restrictions necessary to respect the rights or reputations of others. The restrictions in the proposed Bill are necessary to respect the rights of others; namely the commercial interests of relevant persons (including persons for whom the active constituent, chemical product or label has been or is to be approved or registered).

Considerable investment is required to generate confidential commercial information and protection of this information is necessary to preserve the rights of those persons that have made that investment. Encouraging this kind of investment results in research about chemicals that has the potential to produce benefits for society in general. The protection of the rights of confidential commercial information for persons is consistent across many laws, including therapeutic goods legislation. Conversely, if this investment in confidential commercial information is not protected then persons introducing these chemicals would be discouraged from introducing them to Australia and Australia would not have access to the latest technology for controlling pests and diseases.

Accredited persons are certain persons who would voluntarily apply for accreditation; that is, persons are not compelled to apply for accreditation. Accredited persons would represent a small group of the community with particular skills in assessing the safety, efficacy and other relevant attributes of a chemical. The nature of this assessment task and the need for secrecy for the information provided to these accredited persons would be well understood by these persons.

Item 46 ensures that there are proportionate sanctions for unauthorised disclosure of confidential commercial information: sanctions with which prospective accredited persons will be familiar. Item 46 has a clear legal basis in that it is a clearly articulated requirement about unauthorised disclosure of confidential commercial information. It is publicly available and would be well understood by those particular persons that would seek accreditation as an accredited person.

While item 46 limits the right to freedom of expression for accredited persons, it is for the legitimate and necessary objective of respecting the rights of others that generated the confidential commercial information.

Summary

Part 5 of Schedule 1 to the Bill is compatible with the right to freedom of expression provided for in Article 19(2) of the ICCPR because, while it limits the right to freedom of expression for accredited persons, it is for the legitimate and well-recognised need to respect the rights of others that generated confidential commercial information.

Part 6 of Schedule 1—Voluntary recalls

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.

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 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.

Amended section 106 of the Agvet Code engages the protection against arbitrary or unlawful interference with privacy, as the proposed provision enables information to be collected, used and disclosed by the APVMA. To the extent that section 106 may limit the right to privacy, any limitation is reasonable, necessary and proportionate to the achievement of a legitimate objective of an effective recall.

If a person is recalling a chemical product for a reason set out in subsection 106(1) then new subsection 106(2) requires the person to notify the APVMA of this recall in an approved form within 2 days of undertaking the recall action. The approved form will be a form that the APVMA has approved or that is prescribed in the regulations. New subsection 106(6) provides that where the APVMA is notified of a recall then it must publish a copy of the notice about this recall on its website within 3 working days and in the Gazette within 14 days. These measures will ensure that stakeholders are informed of the recall and will promote the effectiveness of the recall.

The Agvet Code pursues the legitimate objective of regulating the supply of safe and effective agvet chemicals that do not unduly prejudice trade. Amended section 106 of the Agvet Code will ensure that the APVMA can collect, use and disclose information about recalls of agvet chemicals in the marketplace. This information will be used by users of chemical products and ensure that voluntary recalls of agvet chemicals are effective. It is anticipated that disclosure of information will be limited to the details necessary to conduct an effective recall.

Summary

Part 6 of Schedule 1 to the Bill is compatible with human rights because, to the extent that amended section 106 of the Agvet Code 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 of promoting an effective recall.

Right to the presumption of innocence (strict liability offence)

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 requirements are observed and it can be reasonably expected that the person was aware of their duties and obligations in regulatory requirements. Strict liability offences can be considered a limitation of the presumption of innocence because the defendant can be 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 6 of Schedule 1 to the Bill proposes to establish a strict liability offence in new subsection 106(4) of the Agvet Code. The application of strict liability in Part 6 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 106(4) of the Agvet Code provides that a person commits an offence of strict liability, which is subject to a criminal pecuniary penalty of 60 penalty units, if that person contravenes new subsection 106(4) of the Agvet Code. New subsection 106(4) makes it an offence of strict liability to fail or refuse to notify the APVMA of a recall of a chemical product that is being conducted for one of the reasons set out in new subsection 106(1).

The applicable pecuniary penalty of 60 penalty units in new subsection 106(4) of the Agvet Code 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 subsection 106(4) of the Agvet Code will be 300 penalty units, due to the application of subsection 170(5) of the Agvet Code.

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.

It is necessary to prescribe the conduct in new subsection 106(4) of the Agvet Code as an offence of strict liability. This is because it will place persons on notice to guard against the possibility of any contravention of the Agvet Code by encouraging persons voluntarily recalling chemical products that do not comply with the statutory criteria set out in sections 5A to 5 D of the Agvet Code, or which are not registered chemical products, to notify the APVMA of the recall. In addition, it is appropriate for these elements to be strict liability because persons supplying chemical products should know their legal obligations before supplying these products and because the offence is necessary to ensure the integrity of the regulatory scheme.

Notifying the APVMA about recalls of chemical products is essential to ensure the regulator is fully informed of actions being taken to remove products from the market. This is also necessary to ensure the regulator can monitor any public health and environment risks and ensure these are managed through the recall.

Further, the proposed penalty in new subsection 106(4) is consistent with the Guide to Framing Commonwealth Offences, which provides that 50 to 60 penalty units is a comparable penalty for the failure to lodge a return or report. A penalty in the upper range of 60 penalty units is considered appropriate given the potential risks to public safety, the environment, animal and plant health or trade that could be relevant or are being managed by the recall of a chemical product.

In summary, the application of strict liability in new subsection 106(4) is appropriate because:

·            a contravention of new subsection 106(4) of the Agvet Code is not punishable by imprisonment

·            the applicable penalty for the strict liability offence is 60 penalty units for an individual and 300 penalty units for a body corporate (consistent with subsection 170(5) of the Agvet Code)

·            the punishment of the strict liability offence prescribed by new subsection 106(4) of the Agvet Code is likely to significantly enhance the effectiveness of the enforcement regime of the Agvet Code by encouraging persons to notify the APVMA of voluntary recalls of chemical products (where there are potential risks to public safety, the environment, animal and plant health or trade).

Summary

New subsection 106(4) of the Agvet Code, as inserted by Part 6 of Schedule 1 to the Bill, is 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 of notifying the APVMA about recalls to ensure the APVMA can monitor any public health and environment risks.

Civil penalty 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 Code Act 1994

New subsection 106(5) of the Agvet Code provides that new subsection 106(4) of the Agvet Code is a civil penalty provision. New subsection 106(4) makes it an offence of strict liability to fail or refuse to notify the APVMA of a recall of a chemical product that is being conducted for one of the reasons set out in subsection 106(1).

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 50 in Part 6 of Schedule 1 to the Bill, which inserts new subsection 106(5) of the Agvet Code, also inserts a note at the end of new subsection 106(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.

Existing 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.

Existing 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. 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 subsection 106(4) of the Agvet Code is 60 penalty units. Accordingly, the corresponding criminal pecuniary penalty for a body corporate for a contravention of subsection 106(4) of the Agvet Code will be 300 penalty units.

By virtue of section 145AA of the Agvet Code, and the matters prescribed by subsection 106(4) 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 106(5) of the Agvet Code will be 180 penalty units for individuals and 1,500 penalty units for bodies corporate.

The penalty provision proposed to be created by new subsection 106(4) of the Agvet Code is expressly classified as a civil penalty provision by new subsection 106(5) of the Agvet Code. That is, new subsection 106(5) of the Agvet Code seeks 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 subsection 106(5) of the Agvet Code is to encourage compliance with the requirement to notify the APVMA of a recall of a chemical product. New subsection 106(5) of the Agvet Code does not seek to impose criminal liability and does 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, it only applies to persons who would reasonably be expected to be aware of their obligations to inform the APVMA if they are recalling chemical products.

Further, the imposition of the civil pecuniary penalty in new subsection 106(5) of the Agvet Code is 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 106(5) 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, animal and plant health and trade if recalls of agvet chemicals are not notified to the APVMA.

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 subsection 106(5) 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 support that the civil penalty created by new subsection 106(5) of the Agvet Code is a civil penalty rather than a criminal penalty 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 subsection 106(5) of the Agvet Code is 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 subsection 106(5) 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.

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 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

·            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 6 of Schedule 1 to the Bill will only apply in relation to actions taken on or after the commencement of Part 6—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 6 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 subsection 106(5) of the Agvet Code does not engage those rights.

Part 7 of Schedule 1—Notification of new information

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—Definition of registered chemical product

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.

Part 9 of Schedule 1—Suspension or cancellation of approval or registration for provision of false or misleading information

Part 9 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 10 of Schedule 1—Supply of registered chemical product with unapproved label

Part 10 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.

Right to the presumption of innocence (existing reverse burden provisions)

The Bill amends section 81 of the Agvet Code to address an inconsistency in the Agvet Code by clarifying what information must be included on a label. The amendments clarify that the only ‘relevant particulars’ that are required on a label are the ‘instructions’ for use and the ‘particulars to be contained on the label’ as prescribed in regulation 18D of the Code Regulations. The amendments mean that not all relevant particulars are required to be included on a label, whereas the existing offence requires all relevant particulars to be included on a label.

The amendments do not alter the penalty for the offence.

The current section 81 of the Agvet Code also includes an exception and a defence, in which the defendant bears a legal burden for the defence (subsection 81(2)) and an exception in which the defendant bears an evidential burden (subsection 81(3)). The amendments replace the current references to ‘relevant particulars’ with references to ‘minimum information’. For this reason an assessment of the compatibility with human rights has been undertaken.

Laws that shift the burden of proof to a defendant, commonly known as ‘reverse burden provisions’, can be considered a limitation of the presumption of innocence. This is because a defendant’s failure to discharge a burden of proof or prove an absence of fault may permit their conviction despite reasonable doubt as to their guilt. This includes where an evidential or legal burden of proof is placed on a defendant.

When a defendant bears an evidential burden in relation to an exception it means that the defendant bears the burden of adducing or pointing to evidence that suggests a reasonable possibility that the exception has been met. It is then up to the prosecution to establish that this exception does not apply. When a defendant bears a legal burden of proof it means that the defendant must discharge the burden on the balance of probabilities.

Reverse burden offences will not necessarily be inconsistent with the presumption of innocence, provided that the reverse burden pursues a legitimate objective and is reasonable, necessary and proportionate to achieving that objective. Whether a reverse burden provision impermissibly limits the right to the presumption of innocence will depend on the circumstances of the case and the particular justification for the reverse burden.

The Guide to Framing Commonwealth Offences notes that placing the burden of proof on the defendant should be limited to where the matter is peculiarly within the knowledge of the defendant and where it is significantly more difficult and costly for the prosecution to disprove than for the defendant to establish the matter.

The Guide to Framing Commonwealth Offences also notes that a reverse burden provision is more readily justified if:

·            the matter in question is not central to the question of culpability for the offence;

·            the penalties are at the lower end of the scale; and

·            the conduct proscribed by the offence poses a grave danger to public health or safety.

An additional factor to consider is whether the offences only impose an evidential burden—that is, the prosecution must still disprove the matters beyond reasonable doubt if the defendant discharges the evidential burden.

Subsections 81(2) and (3) remain necessary to achieve the legitimate objective of protecting public health and the health of animals, plants and the environment. Chemical products can be extremely hazardous to people, plants, animals and the environment if they are not used in accordance with the instructions for use on the label. These instructions may include important information about the handling of the chemical products, including personal protective equipment for people using the product and how the product may be used safely to protect people and the environment. The label, and the instructions for use in the label, are therefore vital to ensuring the safe and effective use of the chemical product.

Exception in subsection 81(3)

Current subsection 81(3) as amended by the Bill place an evidential burden on the defendant in relation to the labels that are attached to chemical products. The current and amended provision are consistent with the Guide.

Subsection 81(3) deals with a situation where a label has been amended for a chemical product and products with the previously approved label may still be in the supply chain. Subsection 81(3) provides for persons to continue to supply these products for a specified period of time if the APVMA determines that is appropriate. Subsection 81(3) ensures persons can supply chemical products with previously approved labels only if that supply is authorised. This ensures that chemical products can be used safely for the specified period of time that the APVMA determines is appropriate (under current paragraph 81(3)(c) and amended paragraph 81(3)(d)).

Chemical products can have convoluted supply chains with many persons involved in the supply of a chemical product from manufacture through to delivery in rural or regional areas of the country. As products move through this supply chain the relevant persons keep records (invoices) of the supplies they have handled. These records are peculiarly within the knowledge of the person supplying the products and the records allow the person supplying the chemical products to easily provide evidence that chemical products with previously approved labels were supplied within the specified period of time allowed by the APVMA. Reversing the burden in these circumstances is reasonable because the defendant will have the relevant information or knowledge available to them, which would form evidence to support the application of the defence. This task would be considerably more difficult and costly for the prosecution to establish, particularly given the wide distribution of chemical products in Australia. For this reason and to protect the safety of people, plants, animals and the environment, the defendant would continue to bear the evidential burden in relation to the exception in subsection 81(3).

Defence in subsection 81(2)

Current subsection 81(2) as amended by the Bill places a legal burden on the defendant in relation to the labels that are attached to chemical products. The current and amended provisions are consistent with the Guide.

Subsection 81(2) deals with a situation where a product has been supplied and the label does not include the required information or contains information contrary to the required information. This can represent an extremely hazardous situation in that the supply of a chemical product without the required information or with incorrect information could have serious consequences for the public health and safety of people, animals, plants or the environment. These consequences may include death or serious injury to persons, contaminated land or waterways or complete loss of a financially important export market. These consequences may linger for many years.

As previously stated, chemical products can have convoluted supply chains with many persons involved in the supply of a chemical product, including retailers or other persons who would have no technical knowledge about a chemical product. Some persons suppling a chemical product may not have the technical knowledge to know if all the required information is in the label of the product or if the information is contrary to the correct label information, particularly given the technical information that might be included in instructions on a chemical product. Subsection 81(2) provides a defence for these persons, provided they are able to establish that they did not know or could not reasonably be expected to have known the information in a label was missing or contrary to the correct label information.

What a person knows or could reasonably be expected to know is peculiarly within the knowledge of the person and will vary from person to person and may also vary depending on what chemical product is being supplied. For example, a person handling pool chlorine from a store supplying pool chemicals may have more knowledge about the products they supply than a person selling household insecticides in a supermarket. Reversing the burden in these circumstances is both reasonable and proportionate because the defendant will have the relevant information or knowledge available to them, which would form evidence to support the application of the defence in the particular circumstance. This task would be considerably more difficult and costly for the prosecution to establish what a person knows or could reasonably be expected to know in the particular circumstance. For this reason and given both the serious consequences of mislabelled chemical products being supplied and the need to protect the safety of people, plants, animals and the environment, the defendant would continue to bear the legal burden in relation to the defence in subsection 81(2).

Summary

Subsections 81(2) and (3) as amended by the Bill are compatible with human rights. This is 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 of protecting public health and the health of animals, plants and the environment from what may be serious consequences if chemical products are not used in accordance with the approved instructions for use.

Part 11 of Schedule 1—Variation of approval or registration during suspension

Part 11 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 12 of Schedule 1—Safety, efficacy, trade and labelling criteria

Part 12 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 13 of Schedule 1—Annual operational plans

Part 13 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 14 of Schedule 1—Other amendments

Part 14 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.

While Part 14 includes measures to allow the APVMA to reconsider certain matters on its own initiative, these measures do not affect a person’s right to an effective remedy, as there is no change to the circumstances in which a person may request an internal review or apply for AAT review.

Part 14 includes amendments to sections 74, 75, 76 and 78 to omit certain exceptions in these offences. These exceptions have never applied since the National Registration Scheme commenced in 1995. This is because the exceptions only apply if the APVMA makes a specific kind of determination and the APVMA has never had to make these kinds of determinations. The amendments to the notes about evidential burden for these exceptions are editorial amendments to reflect the removal of the exceptions that have never applied. As the exceptions have never applied and the editorial amendments to the notes have no effect, the amendments to sections 74, 75, 76 and 78 in Part 14 do not engage any human rights.

Parts 1 and 2 of Schedule 2—Other amendments

Parts 1 and 2 of Schedule 2 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 Minister for Agriculture and Water Resources,

the Hon. David Littleproud MP)