AGRICULTURAL AND VETERINARY CHEMICALS LEGISLATION AMENDMENT (AUSTRALIAN PESTICIDES AND VETERINARY MEDICINES AUTHORITY BOARD AND OTHER IMPROVEMENTS) BILL 2019

2019

The Parliament of the

Commonwealth of Australia

HOUSE OF REPRESENTATIVES

Presented and read a first time

Agricultural and Veterinary Chemicals

Legislation Amendment (Australian

Pesticides and Veterinary Medicines

Authority Board and Other

Improvements) Bill 2019

No. , 2019

(Agriculture)

A Bill for an Act to amend the law relating to

agricultural and veterinary chemicals, and for

related purposes

No. , 2019

Agricultural and Veterinary Chemicals Legislation Amendment

(Australian Pesticides and Veterinary Medicines Authority Board and

Other Improvements) Bill 2019

Contents

Short title ........................................................................................... 1

Commencement ................................................................................. 1

Schedules ........................................................................................... 3

Schedule 1--Main improvements

Part 1--Information to be taken into account in determining

applications

Agricultural and Veterinary Chemicals Code Act 1994

Part 2--Approval and registration for prescribed active

constituents, chemical products or labels

Agricultural and Veterinary Chemicals Code Act 1994

Part 3--Limits on use of information

Agricultural and Veterinary Chemicals Code Act 1994

Part 4--Annual returns and record-keeping

Agricultural and Veterinary Chemical Products (Collection of Levy)

Act 1994

Agricultural and Veterinary Chemicals (Administration) Act 1992

Part 5--Computerised decision-making

Agricultural and Veterinary Chemicals Code Act 1994

Part 6--Preliminary assessments

Agricultural and Veterinary Chemicals Code Act 1994

Part 7--Variation of relevant particulars and conditions

Agricultural and Veterinary Chemicals Code Act 1994

Part 8--Variation of approval or registration during suspension

Agricultural and Veterinary Chemicals Code Act 1994

Part 9--False and misleading information

Agricultural and Veterinary Chemicals (Administration) Act 1992

Agricultural and Veterinary Chemicals Code Act 1994

Agricultural and Veterinary Chemicals Legislation Amendment

(Australian Pesticides and Veterinary Medicines Authority Board and

Other Improvements) Bill 2019

No. , 2019

Part 10--Suspension or cancellation of approval or registration

for provision of false or misleading information

Agricultural and Veterinary Chemicals Code Act 1994

Part 11--Voluntary recalls

Agricultural and Veterinary Chemicals Code Act 1994

Part 12--Notification of new information

Agricultural and Veterinary Chemicals Code Act 1994

Part 13--Annual operational plans

Agricultural and Veterinary Chemicals (Administration) Act 1992

Part 14--Definition of registered chemical product

Agricultural and Veterinary Chemicals Code Act 1994

Part 15--Supply of registered chemical products with

unapproved label

Agricultural and Veterinary Chemicals Code Act 1994

Part 16--Safety, efficacy, trade and labelling criteria

Agricultural and Veterinary Chemicals Code Act 1994

Part 17--Maximum Residue Limits Standard

Agricultural and Veterinary Chemicals (Administration) Act 1992

Agricultural and Veterinary Chemicals Code Act 1994

Part 18--Expiry date

Agricultural and Veterinary Chemicals Code Act 1994

Part 19--Other amendments

Agricultural and Veterinary Chemicals (Administration) Act 1992

Agricultural and Veterinary Chemicals Code Act 1994

Part 20--Repeals

Agricultural and Veterinary Chemicals Legislation Amendment

(Removing Re-approval and Re-registration) Act 2014

No. , 2019

Agricultural and Veterinary Chemicals Legislation Amendment

(Australian Pesticides and Veterinary Medicines Authority Board and

Other Improvements) Bill 2019

A Bill for an Act to amend the law relating to

agricultural and veterinary chemicals, and for

related purposes

The Parliament of Australia enacts:

1 Short title

This Act is the Agricultural and Veterinary Chemicals Legislation

Amendment (Australian Pesticides and Veterinary Medicines

Authority Board and Other Improvements) Act 2019.

2 Commencement

(1) Each provision of this Act specified in column 1 of the table

commences, or is taken to have commenced, in accordance with

Agricultural and Veterinary Chemicals Legislation Amendment

(Australian Pesticides and Veterinary Medicines Authority Board and

Other Improvements) Bill 2019

No. , 2019

column 2 of the table. Any other statement in column 2 has effect

according to its terms.

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1. Sections 1 to 3

and anything in

this Act not

elsewhere covered

by this table

The day this Act receives the Royal Assent.

2. Schedule 1,

Parts 1 and 2

The day after the end of the period of 6

months beginning on the day this Act

receives the Royal Assent.

3. Schedule 1,

Part 3

A single day to be fixed by Proclamation.

However, if the provisions do not commence

within the period of 3 months beginning on

the day this Act receives the Royal Assent,

they commence on the day after the end of

that period.

4. Schedule 1,

Part 4

The day after this Act receives the Royal

Assent.

5. Schedule 1,

Part 5

A single day to be fixed by Proclamation.

However, if the provisions do not commence

within the period of 6 months beginning on

the day this Act receives the Royal Assent,

they commence on the day after the end of

that period.

6. Schedule 1,

Part 6

The day after the end of the period of 12

months beginning on the day this Act

receives the Royal Assent.

7. Schedule 1,

Parts 7 to 12

The day after the end of the period of 3

months beginning on the day this Act

receives the Royal Assent.

8. Schedule 1,

Part 13

The first 1 January to occur after the day this

Act receives the Royal Assent.

9. Schedule 1,

The day after this Act receives the Royal

No. , 2019

Agricultural and Veterinary Chemicals Legislation Amendment

(Australian Pesticides and Veterinary Medicines Authority Board and

Other Improvements) Bill 2019

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

Parts 14 to 20

Assent.

10. Schedule 2

A single day to be fixed by Proclamation.

However, if the provisions do not commence

within the period of 12 months beginning on

the day this Act receives the Royal Assent,

they commence on the day after the end of

that period.

Note:

This table relates only to the provisions of this Act as originally

enacted. It will not be amended to deal with any later amendments of

this Act.

(2) Any information in column 3 of the table is not part of this Act.

Information may be inserted in this column, or information in it

may be edited, in any published version of this Act.

3 Schedules

Legislation that is specified in a Schedule to this Act is amended or

repealed as set out in the applicable items in the Schedule

concerned, and any other item in a Schedule to this Act has effect

according to its terms.

Schedule 1 Main improvements

Part 1 Information to be taken into account in determining applications

Agricultural and Veterinary Chemicals Legislation Amendment

(Australian Pesticides and Veterinary Medicines Authority Board and

Other Improvements) Bill 2019

No. , 2019

Schedule 1--Main improvements

Part 1--Information to be taken into account in

determining applications

Agricultural and Veterinary Chemicals Code Act 1994

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

Omit "However", substitute "Subject to subsection (2A)".

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

Insert:

(2A) Subsection (2) does not apply to information that is prescribed by

the regulations, and that is provided in the circumstances

prescribed by the regulations, for the purposes of this subsection.

3 Application provision

The amendments of section 8C of the Code set out in the Schedule to

the Agricultural and Veterinary Chemicals Code Act 1994 made by this

Part apply in relation to the following:

(a) applications lodged on or after the commencement of this

item;

(b) applications lodged before the commencement of this item

but not determined by the APVMA before that

commencement.

Main improvements Schedule 1

Approval and registration for prescribed active constituents, chemical products or labels

Part 2

No. , 2019

Agricultural and Veterinary Chemicals Legislation Amendment

(Australian Pesticides and Veterinary Medicines Authority Board and

Other Improvements) Bill 2019

Part 2--Approval and registration for prescribed

active constituents, chemical products or

labels

Agricultural and Veterinary Chemicals Code Act 1994

4 Section 3 of the Code set out in the Schedule

Insert:

prescribed active constituent has the meaning given by

subsection 14C(4).

prescribed chemical product has the meaning given by

subsection 14D(4).

prescribed label for containers for a chemical product has the

meaning given by subsection 14E(4).

5 Before section 9A of the Code set out in the Schedule

Insert:

Subdivision A--Explanation of Division

6 Subsections 9A(2) to (5) of the Code set out in the

Schedule

Repeal the subsections, substitute:

Approval and registration for active constituents, chemical

products or labels after assessment

(2) Subdivision B provides for approval and registration for active

constituents, chemical products or labels after assessment against

certain criteria. Section 10 provides for applications to be made

and applications must meet the application requirements in

section 8A.

(3) The APVMA must complete a preliminary assessment of an

application. If the application passes preliminary assessment, the

Schedule 1 Main improvements

Part 2 Approval and registration for prescribed active constituents, chemical products

or labels

Agricultural and Veterinary Chemicals Legislation Amendment

(Australian Pesticides and Veterinary Medicines Authority Board and

Other Improvements) Bill 2019

No. , 2019

APVMA must notify the applicant and publish a summary of the

application (section 11).

(4) Before determining certain applications that have passed

preliminary assessment, the APVMA must publish a notice

inviting public submissions (sections 12 and 13).

(5) The APVMA must approve an active constituent or label, or

(section 14).

Approval and registration for prescribed active constituents,

chemical products or labels

(5A) Subdivision C provides for approval and registration for a

prescribed active constituent, prescribed chemical product or

prescribed label for containers for a chemical product.

Sections 14C, 14D and 14E provide for applications to be made

and applications must meet the application requirements in

section 8A.

(5B) If an application meets the application requirements, the APVMA

must approve the active constituent or label, or register the

chemical product, if no disqualifying circumstances exist in

relation to the applicant.

Common provisions

7 After section 9A of the Code set out in the Schedule

Insert:

Subdivision B--Approval and registration for active

constituents, chemical products or labels after

assessment

8 After section 14B of the Code set out in the Schedule

Insert:

Main improvements Schedule 1

Approval and registration for prescribed active constituents, chemical products or labels

Part 2

No. , 2019

Agricultural and Veterinary Chemicals Legislation Amendment

(Australian Pesticides and Veterinary Medicines Authority Board and

Other Improvements) Bill 2019

Subdivision C--Approval and registration for prescribed active

constituents, chemical products or labels

14C Applications for approval of prescribed active constituents

(1) A person may apply to the APVMA for approval of a prescribed

active constituent.

Note:

For prescribed active constituent, see subsection (4).

(2) The application must meet the application requirements.

Note:

For meets the application requirements, see section 8A.

(3) The APVMA may alter the application with the written consent of

the applicant.

(4) A prescribed active constituent is an active constituent that:

(a) is for a proposed or existing chemical product; and

(b) is of a kind:

(i) prescribed by the regulations for the purposes of this

subparagraph; or

(ii) determined by the APVMA under subsection (6).

(5) The APVMA must not determine a kind of active constituent under

subsection (6) unless it is satisfied that the kind of active

constituent would meet the safety criteria.

(6) The APVMA may, by legislative instrument, determine a kind of

active constituent for the purposes of subparagraph (4)(b)(ii).

Decision on application

(7) The APVMA must approve the active constituent that is the subject

of the application if it is satisfied that:

(a) the application meets the application requirements; and

(b) the active constituent is a prescribed active constituent; and

subsection (9) apply in relation to the applicant.

Note:

For notice of approval, see section 8F.

Schedule 1 Main improvements

Part 2 Approval and registration for prescribed active constituents, chemical products

or labels

Agricultural and Veterinary Chemicals Legislation Amendment

(Australian Pesticides and Veterinary Medicines Authority Board and

Other Improvements) Bill 2019

No. , 2019

(8) Otherwise, the APVMA must refuse the application.

Note:

For notice of refusal, see section 8G.

Disqualifying circumstances

(9) The APVMA may, by legislative instrument, determine

circumstances for the purposes of paragraph (7)(c).

14D Applications for registration of prescribed chemical products

(1) A person may apply to the APVMA for registration of a prescribed

chemical product.

Note:

For prescribed chemical product, see subsection (4).

(2) The application must meet the application requirements.

Note:

For meets the application requirements, see section 8A.

(3) The APVMA may alter the application with the written consent of

the applicant.

(4) A prescribed chemical product is a chemical product that is of a

kind:

(a) prescribed by the regulations for the purposes of this

paragraph; or

(b) determined by the APVMA under subsection (6).

(5) The APVMA must not determine a kind of chemical product under

subsection (6) unless it is satisfied that the kind of chemical

product would:

(a) meet the safety criteria, the trade criteria and the efficacy

criteria; or

(b) comply with the established standard for the kind of chemical

product.

(6) The APVMA may, by legislative instrument, determine a kind of

chemical product for the purposes of paragraph (4)(b).

Main improvements Schedule 1

Approval and registration for prescribed active constituents, chemical products or labels

Part 2

No. , 2019

Agricultural and Veterinary Chemicals Legislation Amendment

(Australian Pesticides and Veterinary Medicines Authority Board and

Other Improvements) Bill 2019

Decision on application

(7) The APVMA must register the chemical product that is the subject

of the application if it is satisfied that:

(a) the application meets the application requirements; and

(b) the chemical product is a prescribed chemical product; and

subsection (9) apply in relation to the applicant.

Note:

For notice of approval, see section 8F.

(8) Otherwise, the APVMA must refuse the application.

Note:

For notice of refusal, see section 8G.

Disqualifying circumstances

(9) The APVMA may, by legislative instrument, determine

circumstances for the purposes of paragraph (7)(c).

14E Applications for approval of prescribed labels for containers for

chemical products

(1) A person may apply to the APVMA for approval of a prescribed

label for containers for a chemical product.

Note:

For prescribed label for containers for a chemical product, see

subsection (4).

(2) The application must meet the application requirements.

Note:

For meets the application requirements, see section 8A.

(3) The APVMA may alter the application with the written consent of

the applicant.

(4) A prescribed label for containers for a chemical product is a

label:

(a) for containers for a chemical product; and

(b) that is of a kind:

(i) prescribed by the regulations for the purposes of this

subparagraph; or

(ii) determined by the APVMA under subsection (6).

Schedule 1 Main improvements

Part 2 Approval and registration for prescribed active constituents, chemical products

or labels

Agricultural and Veterinary Chemicals Legislation Amendment

(Australian Pesticides and Veterinary Medicines Authority Board and

Other Improvements) Bill 2019

No. , 2019

(5) The APVMA must not determine a kind of label under

subsection (6) unless it is satisfied that the kind of label would:

(a) meet the labelling criteria; or

(b) comply with the established standard for the chemical

product.

(6) The APVMA may, by legislative instrument, determine a kind of

label for the purposes of subparagraph (4)(b)(ii).

(7) Without limiting subsection (6), a kind of label may be described

by reference to a kind of chemical product.

Decision on application

(8) The APVMA must approve the label that is the subject of the

application if it is satisfied that:

(a) the application meets the application requirements; and

(b) the label that is the subject of the application is a prescribed

label for containers for a chemical product; and

subsection (10) apply in relation to the applicant.

Note:

For notice of approval, see section 8F.

(9) Otherwise, the APVMA must refuse the application.

Note:

For notice of refusal, see section 8G.

Disqualifying circumstances

(10) The APVMA may, by legislative instrument, determine

circumstances for the purposes of paragraph (8)(c).

Subdivision D--Common provisions

9 Paragraphs 17(3)(a) and (b) of the Code set out in the

Schedule

After "section 14", insert "or 14C".

Main improvements Schedule 1

Approval and registration for prescribed active constituents, chemical products or labels

Part 2

No. , 2019

Agricultural and Veterinary Chemicals Legislation Amendment

(Australian Pesticides and Veterinary Medicines Authority Board and

Other Improvements) Bill 2019

10 After subsection 34G(1) of the Code set out in the

Schedule

Insert:

(1AA) The APVMA must not use the following information to assess or

make a decision on an application made under section 14C, 14D or

14E:

(a) information given to the APVMA in connection with an

application made under section 10 or 27 by the applicant for

that application;

(b) information given under section 161.

11 Subsection 34G(1B) of the Code set out in the Schedule

After "subsections (1)", insert ", (1AA)".

12 Subparagraph 166(1A)(b)(i) of the Code set out in the

Schedule

After "subsection 14(2)", insert ", 14C(8), 14D(8) or 14E(9)".

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

After "subsection 14(1)", insert ", 14C(7), 14D(7) or 14E(8)".

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

After "subsection 14(2)", insert ", 14C(8), 14D(8) or 14E(9)".

Schedule 1 Main improvements

Part 3 Limits on use of information

Agricultural and Veterinary Chemicals Legislation Amendment

(Australian Pesticides and Veterinary Medicines Authority Board and

Other Improvements) Bill 2019

No. , 2019

Part 3--Limits on use of information

Agricultural and Veterinary Chemicals Code Act 1994

15 Section 3 of the Code set out in the Schedule (at the end

of the definition of limitation period)

Add:

Note:

See also section 34MA (which deals with extensions of limitation

periods).

16 Section 3 of the Code set out in the Schedule

(paragraph (b) of the definition of protected active

constituent)

Repeal the paragraph, substitute:

(b) the term of the letters patent (including any extension of that

term):

(i) has ended; or

(ii) will end during the protection period (including that

period as extended) that applies to protected information

about that constituent;

17 Section 3 of the Code set out in the Schedule

(paragraph (b) of the definition of protected chemical

product)

Repeal the paragraph, substitute:

(b) the term of the letters patent (including any extension of that

term):

(i) has ended; or

(ii) will end during the protection period (including that

period as extended) that applies to protected information

about that product;

18 Section 3 of the Code set out in the Schedule (at the end

of the definition of protection period)

Add:

Main improvements Schedule 1

Limits on use of information Part 3

No. , 2019

Agricultural and Veterinary Chemicals Legislation Amendment

(Australian Pesticides and Veterinary Medicines Authority Board and

Other Improvements) Bill 2019

Note:

See also section 34KA (which deals with extensions of the protection

period).

19 Subsection 34F(4) of the Code set out in the Schedule

After "34K", insert ", 34KA".

20 Subsection 34F(5) of the Code set out in the Schedule

Omit "Section 34M sets", substitute "Sections 34M and 34MA set".

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

Repeal the subsection, substitute:

Protected information whose protection period has expired

(5A) Another condition is that the information is protected information

and either:

(a) the protection period in relation to that information has

ended; or

(b) if the protection period in relation to that information is

extended in accordance with regulations made for the

purposes of section 34KA--the protection period, as

extended, has ended.

Note:

For protected information and protection period, see section 3 and

Part 3.

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

Insert:

34KA Extension of protection periods

(1) The regulations may make provision for and in relation to either or

both of the following:

(a) extending the protection period in relation to protected

information;

(b) ending such an extension.

(2) An application for an extension is not required.

Schedule 1 Main improvements

Part 3 Limits on use of information

Agricultural and Veterinary Chemicals Legislation Amendment

(Australian Pesticides and Veterinary Medicines Authority Board and

Other Improvements) Bill 2019

No. , 2019

(3) Instead, an extension of a protection period must not occur unless,

at least 3 years before that protection period (including that period

as previously extended) will end, an application that satisfies the

following is lodged:

(a) the application is under a provision of this Part prescribed by

the regulations for the purposes of this paragraph;

(b) the application satisfies the requirements prescribed by the

regulations for the purposes of this paragraph.

Maximum extension

(4) The total length of all extensions of a protection period, in relation

to particular protected information, must not be more than 5 years.

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

Omit "The table", substitute "Subject to section 34MA, the table".

24 At the end of subsection 34M(1) of the Code set out in the

Schedule

Add:

Note:

Section 34MA deals with extensions of the limitation period.

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

the Schedule

Add:

34MA Extension of limitation periods

(1) The regulations may make provision for and in relation to either or

both of the following:

(a) extending the limitation period for information covered by an

item of the table in subsection 34M(1);

(b) ending such an extension.

(2) An application for an extension is not required.

(3) Instead, an extension of a limitation period must not occur unless,

at least 3 years before that limitation period (including that period

Main improvements Schedule 1

Limits on use of information Part 3

No. , 2019

Agricultural and Veterinary Chemicals Legislation Amendment

(Australian Pesticides and Veterinary Medicines Authority Board and

Other Improvements) Bill 2019

as previously extended) will end, an application that satisfies the

following is lodged:

(a) the application is under a provision of this Part prescribed by

the regulations for the purposes of this paragraph;

(b) the application satisfies the requirements prescribed by the

regulations for the purposes of this paragraph.

Maximum extension

(4) The total length of all extensions of a limitation period, for

particular information covered by an item of the table in

subsection 34M(1), must not be more than 5 years.

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

After "protection period", insert "(including that period as extended)".

27 Application provisions

(1)

Section 34KA of the Code set out in the Schedule to the Agricultural

and Veterinary Chemicals Code Act 1994, as inserted by this Part,

applies in relation to a protection period beginning before, on or after

the day this item commences.

(2)

Section 34MA of the Code set out in the Schedule to the Agricultural

and Veterinary Chemicals Code Act 1994, as added by this Part, applies

in relation to a limitation period beginning before, on or after the day

this item commences.

Schedule 1 Main improvements

Part 4 Annual returns and record-keeping

Agricultural and Veterinary Chemicals Legislation Amendment

(Australian Pesticides and Veterinary Medicines Authority Board and

Other Improvements) Bill 2019

No. , 2019

Part 4--Annual returns and record-keeping

Agricultural and Veterinary Chemical Products (Collection

of Levy) Act 1994

28 Subsection 3(1)

Insert:

active constituent has the same meaning as in the Agricultural and

Veterinary Chemicals Code set out in the Schedule to the

Agricultural and Veterinary Chemicals Code Act 1994.

29 After section 34

Insert:

35 Annual returns by interested persons

(1) The interested person in relation to a chemical product who is

liable to pay levy in respect of leviable disposals of the product that

took place anywhere in Australia at any time during a financial

year must give the APVMA, before 30 November in the next

financial year, a return setting out the total quantity of the chemical

product covered by those leviable disposals.

Note:

See also sections 37A and 37B.

Strict liability offence

(2) A person commits an offence of strict liability if the person

contravenes subsection (1).

Penalty: 50 penalty units.

Civil penalty

(3) Subsection (1) is a civil penalty provision.

Note 1:

For monitoring and investigation powers of inspectors in relation to

this Act, see Part 7AA of the Agricultural and Veterinary Chemicals

(Administration) Act 1992.

Note 2:

Division 1 of Part 7AB of the Agricultural and Veterinary Chemicals

(Administration) Act 1992 provides for pecuniary penalties for

contraventions of civil penalty provisions.

Note 3:

For infringement notices, enforceable undertakings and formal

warnings in relation to contraventions of subsection (1), see

Divisions 2, 3 and 6 of Part 7AB of the Agricultural and Veterinary

Chemicals (Administration) Act 1992.

37A Main constitutional basis of sections 35 and 37

Sections 35 and 37 rely on the Commonwealth's legislative powers

under paragraphs 51(xi) (census and statistics) and (xxxix)

(incidental matters) of the Constitution.

37B Other constitutional bases of sections 35 and 37

(1) Independently of section 37A, sections 35 and 37 also have effect

as provided by this section.

Trade and commerce

(2) Sections 35 and 37 also have the effect they would have if a

reference to a leviable disposal were expressly confined to a

leviable disposal that occurs in the course of:

Main improvements Schedule 1

Annual returns and record-keeping Part 4

No. , 2019

Agricultural and Veterinary Chemicals Legislation Amendment

(Australian Pesticides and Veterinary Medicines Authority Board and

Other Improvements) Bill 2019

(a) trade or commerce between Australia and places outside

Australia; or

(b) trade or commerce among the States; or

Territory or between 2 Territories.

Corporations

(3) Sections 35 and 37 also have the effect they would have if a

reference to a leviable disposal were expressly confined to a

leviable disposal by a corporation to which paragraph 51(xx) of the

Constitution applies.

Territories

(4) Sections 35 and 37 also have the effect they would have if a

reference to a leviable disposal were expressly confined to a

leviable disposal that occurs in a Territory.

31 Application provisions

(1)

Section 35 of the Agricultural and Veterinary Chemical Products

(Collection of Levy) Act 1994, as inserted by this Part, applies in

relation to leviable disposals that take place in the financial year in

which this item commences or in a later financial year.

(2)

Section 37 of the Agricultural and Veterinary Chemical Products

(Collection of Levy) Act 1994, as inserted by this Part, applies in

relation to leviable disposals that take place on or after the

commencement of this item.

Agricultural and Veterinary Chemicals (Administration) Act

1992

32 Section 69E

Repeal the section.

33 Subsection 69EA(1) (heading)

Repeal the heading, substitute:

Schedule 1 Main improvements

Part 4 Annual returns and record-keeping

Agricultural and Veterinary Chemicals Legislation Amendment

(Australian Pesticides and Veterinary Medicines Authority Board and

Other Improvements) Bill 2019

No. , 2019

Records relating to compliance with sections 69B and 69C

34 Paragraph 69EA(1)(a)

Omit "69B, 69C and 69E", substitute "69B and 69C".

35 Saving provisions

(1)

Despite the repeal of section 69E of the Agricultural and Veterinary

Chemicals (Administration) Act 1992 made by this Part, that section, as

in force immediately before the commencement of this item, continues

to apply on and after that commencement in respect of the following:

(a) the import, manufacture or export of active constituents

referred to in paragraph 69E(1)(a) of that Act that occurred in

a financial year that ended before the commencement of this

item;

(b) the import, manufacture or export of chemical products

referred to in paragraph 69E(1)(b) of that Act that occurred in

a financial year that ended before the commencement of this

item.

(2)

Despite the amendments of section 69EA of the Agricultural and

Veterinary Chemicals (Administration) Act 1992 made by this Part, that

section, as in force immediately before the commencement of this item,

continues to apply on and after that commencement in relation to the

keeping and retaining of records in respect of the matters covered by

paragraphs (1)(a) and (b) of this item.

Main improvements Schedule 1

Computerised decision-making Part 5

No. , 2019

Agricultural and Veterinary Chemicals Legislation Amendment

(Australian Pesticides and Veterinary Medicines Authority Board and

Other Improvements) Bill 2019

Part 5--Computerised decision-making

Agricultural and Veterinary Chemicals Code Act 1994

36 Before section 6 of the Code set out in the Schedule

Insert:

5F APVMA may arrange for use of computer programs to make

decisions

(1) The APVMA may arrange for the use, under the APVMA's

control, of computer programs for any purposes for which the

APVMA may, or must, under this Code:

(a) make a decision; or

(b) exercise any power or comply with any obligation; or

paragraph (a) applies or related to exercising a power, or

complying with an obligation, to which paragraph (b)

applies.

(2) For the purposes of this Code, the APVMA is taken to have:

(a) made a decision; or

(b) exercised a power or complied with an obligation; or

the exercise of a power or the compliance with an obligation;

that was made, exercised, complied with or done by the operation

of a computer program under an arrangement made under

subsection (1).

Substituted decisions

(3) The APVMA may substitute a decision for a decision (the initial

decision) the APVMA is taken, under paragraph (2)(a), to have

made if the APVMA is satisfied that the initial decision is

incorrect.

Schedule 1 Main improvements

Part 5 Computerised decision-making

Agricultural and Veterinary Chemicals Legislation Amendment

(Australian Pesticides and Veterinary Medicines Authority Board and

Other Improvements) Bill 2019

No. , 2019

(4) However, the substituted decision may only be made before the

end of the period of 60 days beginning on the day the initial

decision is made.

37 Paragraph 166(1)(a) of the Code set out in the Schedule

Repeal the paragraph, substitute:

(a) a decision (the reviewable decision) on a particular matter

(the relevant matter):

(i) has been made under this Code on behalf of the

APVMA by a member of the staff of the APVMA; or

(ii) is taken, under paragraph 5F(2)(a), to have been made

by the APVMA for the purposes of this Code; and

38 Paragraph 166(1)(b) of the Code set out in the Schedule

Omit "original decision", substitute "reviewable decision".

39 Paragraph 166(1A)(a) of the Code set out in the Schedule

Repeal the paragraph, substitute:

(a) a decision (the reviewable decision) on a particular matter

(the relevant matter):

(i) has been made under this Code on behalf of the

APVMA by a member of the staff of the APVMA; or

(ii) is taken, under paragraph 5F(2)(a), to have been made

by the APVMA for the purposes of this Code; and

40 Paragraphs 166(1A)(b) and (c) of the Code set out in the

Schedule

Omit "original decision" (wherever occurring), substitute "reviewable

decision".

41 After subsection 166(1A) of the Code set out in the

Schedule

Insert:

(1B) This section also applies if:

Main improvements Schedule 1

Computerised decision-making Part 5

No. , 2019

Agricultural and Veterinary Chemicals Legislation Amendment

(Australian Pesticides and Veterinary Medicines Authority Board and

Other Improvements) Bill 2019

(a) the APVMA is taken, under paragraph 5F(2)(a), to have

made a decision (the initial decision) for the purposes of this

Code; and

(b) under this section, a person may request the APVMA to

reconsider the initial decision; and

(the reviewable decision) for the initial decision.

42 Subsections 166(2) to (4A) and (5) to (7) of the Code set

out in the Schedule

Omit "original decision" (wherever occurring), substitute "reviewable

decision".

43 After subsection 167(2A) of the Code set out in the

Schedule

Insert:

(2B) If:

(a) the APVMA is taken, under paragraph 5F(2)(a), to have

made a decision (the initial decision) for the purposes of this

Code; and

(b) under subsection (1) of this section, an application may be

made to the Administrative Appeals Tribunal for review of

the initial decision; and

for the initial decision;

an application may be made to the Administrative Appeals

Tribunal for review of the substituted decision.

44 Application and saving provisions

(1)

The amendments of section 166 of the Code set out in the Schedule to

the Agricultural and Veterinary Chemicals Code Act 1994 made by this

Part apply in relation to reviewable decisions made on or after the

commencement of this item.

(2)

Section 166 of the Code set out in the Schedule to the Agricultural and

Veterinary Chemicals Code Act 1994, as in force immediately before

the commencement of this item, continues to apply on and after that

Main improvements Schedule 1

Preliminary assessments Part 6

No. , 2019

Agricultural and Veterinary Chemicals Legislation Amendment

(Australian Pesticides and Veterinary Medicines Authority Board and

Other Improvements) Bill 2019

Part 6--Preliminary assessments

Agricultural and Veterinary Chemicals Code Act 1994

45 Subsection 11(2) of the Code set out in the Schedule

Omit "from the preliminary assessment", substitute "to the APVMA,

after completing a preliminary assessment of the application or after

defects in the application have been rectified in response to a notice

under subsection (3),".

46 Subsection 11(3) of the Code set out in the Schedule

Repeal the subsection, substitute:

(3) If it appears to the APVMA, after completing a preliminary

assessment of the application, that the application does not meet

the application requirements but that the defects in the application

can reasonably be rectified, the APVMA must, within 14 days,

give written notice to the applicant:

(a) stating that the application does not meet the application

requirements; and

(b) giving particulars of the defects in the application; and

(3A) The APVMA must refuse the application if:

(a) the APVMA is not satisfied that defects in the application

can reasonably be rectified; or

(b) the defects are not rectified to the satisfaction of the APVMA

within the period mentioned in paragraph (3)(c).

Note:

For notice of refusal, see section 8G.

47 Subsection 28(2) of the Code set out in the Schedule

Omit "from the preliminary assessment", substitute "to the APVMA,

after completing a preliminary assessment of the application or after

defects in the application have been rectified in response to a notice

under subsection (3),".

Schedule 1 Main improvements

Part 6 Preliminary assessments

Agricultural and Veterinary Chemicals Legislation Amendment

(Australian Pesticides and Veterinary Medicines Authority Board and

Other Improvements) Bill 2019

No. , 2019

48 Subsection 28(3) of the Code set out in the Schedule

Repeal the subsection, substitute:

(3) If it appears to the APVMA, after completing a preliminary

assessment of the application, that the application does not meet

the application requirements but that the defects in the application

can reasonably be rectified, the APVMA must, within 14 days,

give written notice to the applicant:

(a) stating that the application does not meet the application

requirements; and

(b) giving particulars of the defects in the application; and

(3A) The APVMA must refuse the application if:

(a) the APVMA is not satisfied that defects in the application

can reasonably be rectified; or

(b) the defects are not rectified to the satisfaction of the APVMA

within the period mentioned in paragraph (3)(c).

Note:

For notice of refusal, see section 8G.

49 Subsection 110A(2) of the Code set out in the Schedule

Omit "from the preliminary assessment", substitute "to the APVMA,

after completing a preliminary assessment of the application or after

defects in the application have been rectified in response to a notice

under subsection (3),".

50 Subsection 110A(3) of the Code set out in the Schedule

Omit "from the preliminary assessment", substitute "to the APVMA,

after completing a preliminary assessment of the application,".

51 Application provision

The amendments made by this Part apply in relation to applications

lodged under section 10, 27 or 110 of the Code set out in the Schedule

to the Agricultural and Veterinary Chemicals Code Act 1994 on or after

the commencement of this item.

Main improvements Schedule 1

Variation of relevant particulars and conditions Part 7

No. , 2019

Agricultural and Veterinary Chemicals Legislation Amendment

(Australian Pesticides and Veterinary Medicines Authority Board and

Other Improvements) Bill 2019

Part 7--Variation of relevant particulars and

conditions

Agricultural and Veterinary Chemicals Code Act 1994

52 At the end of subsection 8S(1) of the Code set out in the

Schedule (before the note)

Add:

; or (c) varies, under section 29, relevant particulars or conditions in

a way other than set out in the application.

53 After paragraph 8S(2)(a) of the Code set out in the

Schedule

Insert:

(b) for notice under paragraph (1)(c)--set out the proposed

variation; and

54 Paragraphs 29(1)(b), (c) and (d) of the Code set out in the

Schedule

Omit "in accordance with the application", substitute "in a particular

way (which may not be the same way as set out in the application)".

55 After paragraph 167(1)(c) of the Code set out in the

Schedule

Insert:

(ca) a decision under subsection 29(1) to vary relevant particulars

or conditions in a way other than set out in the application for

variation;

56 Application provision

The amendments made by this Part apply in relation to an application

lodged under section 27 of the Code set out in the Schedule to the

Agricultural and Veterinary Chemicals Code Act 1994 on or after the

commencement of this item.

Schedule 1 Main improvements

Part 8 Variation of approval or registration during suspension

Agricultural and Veterinary Chemicals Legislation Amendment

(Australian Pesticides and Veterinary Medicines Authority Board and

Other Improvements) Bill 2019

No. , 2019

Part 8--Variation of approval or registration during

suspension

Agricultural and Veterinary Chemicals Code Act 1994

57 Section 42 of the Code set out in the Schedule (heading)

Repeal the heading, substitute:

42 Suspension or cancellation of approval or registration at request

of holder

58 Subparagraph 42(1)(a)(i) of the Code set out in the

Schedule

After "to", insert "suspend or".

59 Subsection 42(1) of the Code set out in the Schedule

Omit "the APVMA must cancel the approval or registration", substitute

"the APVMA must suspend or cancel the approval or registration (as

the case may be)".

60 Subsection 43(2) of the Code set out in the Schedule

Omit "An", substitute "Subject to this section, an".

61 At the end of section 43 of the Code set out in the

Schedule

Add:

(4) A suspension of an approval or registration does not prevent:

(a) the lodging of a notice under section 26AB of one or more

notifiable variations of the relevant particulars of the

approval or registration or the dealing with the notice; or

(b) an application being made under section 26B for one or more

prescribed variations of the relevant particulars of the

approval or registration or the dealing with the application; or

Main improvements Schedule 1

Variation of approval or registration during suspension Part 8

No. , 2019

Agricultural and Veterinary Chemicals Legislation Amendment

(Australian Pesticides and Veterinary Medicines Authority Board and

Other Improvements) Bill 2019

variation of the relevant particulars or conditions of the

approval or registration or the dealing with the application; or

(d) a variation under section 29A of the relevant particulars or

conditions of the approval or registration.

(5) A notice referred to in paragraph (4)(a), an application referred to

in paragraph (4)(b) or (c) or a variation referred to in

paragraph (4)(d) must be in relation to the reasons for the

suspension of the approval or registration.

62 Subsection 45A(2) of the Code set out in the Schedule

Omit "subsection (1)", substitute "paragraph (1)(a)".

63 Paragraph 45A(2)(b) of the Code set out in the Schedule

Omit "in respect of a suspension or cancellation of the approval of an

active constituent for a proposed or existing chemical product or the

registration of a chemical product--".

64 Subsection 45A(4) of the Code set out in the Schedule

After "notice of the", insert "suspension or".

65 Subsection 45A(4) of the Code set out in the Schedule

After "requested the", insert "suspension or".

66 Application provisions

(1)

The amendments of section 42 of the Code set out in the Schedule to the

Agricultural and Veterinary Chemicals Code Act 1994 made by this

Part apply in relation to requests made on or after the commencement of

this item.

(2)

The amendments of section 43 of the Code set out in the Schedule to the

Agricultural and Veterinary Chemicals Code Act 1994 made by this

Part apply in relation to:

(a) a suspension made on or after the commencement of this

item; and

(b) a suspension made before the commencement of this item

that was in effect immediately before that commencement.

Schedule 1 Main improvements

Part 8 Variation of approval or registration during suspension

Agricultural and Veterinary Chemicals Legislation Amendment

(Australian Pesticides and Veterinary Medicines Authority Board and

Other Improvements) Bill 2019

No. , 2019

(3)

The amendments of section 45A of the Code set out in the Schedule to

the Agricultural and Veterinary Chemicals Code Act 1994 made by this

Part apply in relation to a suspension or cancellation made on or after

the commencement of this item.

Main improvements Schedule 1

False and misleading information Part 9

No. , 2019

Agricultural and Veterinary Chemicals Legislation Amendment

(Australian Pesticides and Veterinary Medicines Authority Board and

Other Improvements) Bill 2019

Part 9--False and misleading information

Agricultural and Veterinary Chemicals (Administration) Act

1992

67 Before subsection 69ER(1)

Insert:

Offences

68 At the end of section 69ER

Add:

Civil penalties

(3) A person must not, for the purposes of, or in connection with, the

making of a decision by the APVMA as to whether it should give a

consent under section 69B:

(a) give information (whether orally or in writing) that the

person knows to be false or misleading in a material

particular; or

(b) produce a document that the person knows to be false or

misleading in a material particular without:

(i) indicating to the person to whom the document is

produced that it is false or misleading and the respect in

which it is false or misleading; and

(ii) providing correct information to that person if the

person producing the document is in possession of, or

can reasonably acquire, the correct information.

(4) A person must not, in compliance or purported compliance with a

requirement made by an inspector under Part 7A, Part 7AA or this

Part or for the purposes of, or in connection with, any provision of

Part 7A (other than section 69B), Part 7AA or this Part:

(a) give information (whether orally or in writing) that the

person knows to be false or misleading in a material

particular; or

Schedule 1 Main improvements

Part 9 False and misleading information

Agricultural and Veterinary Chemicals Legislation Amendment

(Australian Pesticides and Veterinary Medicines Authority Board and

Other Improvements) Bill 2019

No. , 2019

(b) produce a document that the person knows to be false or

misleading in a material particular without:

(i) indicating to the person to whom the document is

produced that it is false or misleading and the respect in

which it is false or misleading; and

(ii) providing correct information to that person if the

person producing the document is in possession of, or

can reasonably acquire, the correct information.

(5) Subsections (3) and (4) are civil penalty provisions.

Note:

Division 1 provides for pecuniary penalties for contraventions of civil

penalty provisions.

Agricultural and Veterinary Chemicals Code Act 1994

69 Before subsection 146(1) of the Code set out in the

Schedule

Insert:

Offences

70 At the end of section 146 of the Code set out in the

Schedule

Add:

Civil penalties

(3) A person must not, for the purposes of, or in connection with, the

consideration by the APVMA, in the course of the performance of

any of its functions or the exercise of any of its powers under this

Code, of any matters referred to in section 5A, 5B, 5C or 5D or

subsection 123(1):

(a) give information (whether orally or in writing) that the

person knows to be false or misleading in a material

particular; or

(b) produce a document that the person knows to be false or

misleading in a material particular without:

Main improvements Schedule 1

False and misleading information Part 9

No. , 2019

Agricultural and Veterinary Chemicals Legislation Amendment

(Australian Pesticides and Veterinary Medicines Authority Board and

Other Improvements) Bill 2019

(i) indicating to the person to whom the document is

produced that it is false or misleading and the respect in

which it is false or misleading; and

(ii) providing correct information to that person if the

person producing the document is in possession of, or

can reasonably acquire, the correct information.

(4) A person must not, for the purposes of, or in connection with, the

consideration by the APVMA, in the course of the performance of

any of its functions or the exercise of any of its powers under this

Code, of any matters other than matters referred to in

subsection (3):

(a) give information (whether orally or in writing) that the

person knows to be false or misleading in a material

particular; or

(b) produce a document that the person knows to be false or

misleading in a material particular without:

(i) indicating to the person to whom the document is

produced that it is false or misleading and the respect in

which it is false or misleading; and

(ii) providing correct information to that person if the

person producing the document is in possession of, or

can reasonably acquire, the correct information.

(5) Subsections (3) and (4) are civil penalty provisions.

Note:

Division 2 provides for pecuniary penalties for contraventions of civil

penalty provisions.

71 Application provision

The amendments made by this Part apply in relation to information

given, or a document produced, on or after the commencement of this

item.

Schedule 1 Main improvements

Part 10 Suspension or cancellation of approval or registration for provision of false or

misleading information

Agricultural and Veterinary Chemicals Legislation Amendment

(Australian Pesticides and Veterinary Medicines Authority Board and

Other Improvements) Bill 2019

No. , 2019

Part 10--Suspension or cancellation of approval or

registration for provision of false or

misleading information

Agricultural and Veterinary Chemicals Code Act 1994

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

Omit "the holder", substitute "a person".

73 Section 38A of the Code set out in the Schedule

Repeal the section, substitute:

38A Suspension or cancellation of approval or registration for

provision of false or misleading information

The APVMA may suspend or cancel an approval or registration if:

(a) a person has given information:

(i) in, or in connection with, the application for the

approval or registration; or

(ii) in connection with a variation of the approval or

registration; or

(iii) in response to a notice under subsection 32(1) or

section 33 or 159; or

(iv) as required by section 160A or 161; and

(b) the information was false or misleading in a material

particular.

74 Application provision

Section 38A of the Code set out in the Schedule to the Agricultural and

Veterinary Chemicals Code Act 1994, as substituted by this Part, applies

in relation to information given on or after the commencement of this

item.

Main improvements Schedule 1

Voluntary recalls Part 11

No. , 2019

Agricultural and Veterinary Chemicals Legislation Amendment

(Australian Pesticides and Veterinary Medicines Authority Board and

Other Improvements) Bill 2019

Part 11--Voluntary recalls

Agricultural and Veterinary Chemicals Code Act 1994

75 Section 100 of the Code set out in the Schedule

Before "This Part", insert "(1)".

76 At the end of section 100 of the Code set out in the

Schedule

Add:

(2) This Part also provides for voluntary recalls of chemical products

(see section 106).

77 Section 106 of the Code set out in the Schedule

Repeal the section, substitute:

106 Notification to APVMA of voluntary recalls

(1) This section applies if a person voluntarily takes action to recall a

chemical product because it appears to the person that:

(a) either or both of the following apply:

(i) the chemical product may not meet the safety criteria,

the trade criteria or the efficacy criteria;

(ii) a label for containers for the chemical product may not

meet the labelling criteria; or

(b) the chemical product is not a registered chemical product.

(2) The person must, within 2 days after taking the action, give the

APVMA a notice that:

(a) is in writing in the approved form; and

(b) contains the information required by the approved form.

(3) Subsection (2) does not apply in the circumstances prescribed by

the regulations for the purposes of this subsection.

Schedule 1 Main improvements

Part 11 Voluntary recalls

Agricultural and Veterinary Chemicals Legislation Amendment

(Australian Pesticides and Veterinary Medicines Authority Board and

Other Improvements) Bill 2019

No. , 2019

Offence

(4) A person commits an offence of strict liability if:

(a) the person is required by subsection (2) to give a notice to the

APVMA; and

(b) the person refuses or fails to give the notice as required by

that subsection.

Penalty: 60 penalty units.

Civil penalty

(5) Subsection (2) is a civil penalty provision.

Note:

Division 2 of Part 9A provides for pecuniary penalties for

contraventions of civil penalty provisions.

APVMA to publish notice of recall

(6) If a notice is given to the APVMA under subsection (2), the

APVMA:

(a) must, within 3 working days, publish a copy of the notice on

its website; and

(b) must, within 14 days, publish a copy of the notice in the

Gazette.

The APVMA may also make available a copy of the notice in any

other manner that it thinks appropriate.

(7) Subsection (6) does not apply in the circumstances prescribed by

the regulations for the purposes of this subsection.

No limit on the Competition and Consumer Act 2010

(8) This section does not limit section 128 of Schedule 2 to the

Competition and Consumer Act 2010 (about voluntary recall of

consumer goods).

78 Application provision

Section 106 of the Code set out in the Schedule to the Agricultural and

Veterinary Chemicals Code Act 1994, as substituted by this Part, applies

in relation to action taken on or after the commencement of this item.

Main improvements Schedule 1

Notification of new information Part 12

No. , 2019

Agricultural and Veterinary Chemicals Legislation Amendment

(Australian Pesticides and Veterinary Medicines Authority Board and

Other Improvements) Bill 2019

Part 12--Notification of new information

Agricultural and Veterinary Chemicals Code Act 1994

79 Subparagraph 160A(1)(a)(v) of the Code set out in the

Schedule

Omit "and", substitute "or".

80 At the end of paragraph 160A(1)(a) of the Code set out in

the Schedule

Add:

(vi) approval of a label for containers for a chemical

product; or

(vii) variation of the relevant particulars or conditions of the

approval of an active constituent, of the registration of a

chemical product or of the approval of a label for

containers for a chemical product; and

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

Omit "or in relation to the product or any of its constituents", substitute

"in relation to the product or any of its constituents or in relation to the

label".

82 Subparagraph 160A(4)(a)(ii) of the Code set out in the

Schedule

After "or 20(1)(c)", insert "or relates to the matters covered by

subparagraph 21(c)(iv) or (iva)".

83 At the end of paragraph 160A(4)(b) of the Code set out in

the Schedule

Add "or that the label may not meet the labelling criteria".

84 After paragraph 161(1)(b) of the Code set out in the

Schedule

Insert:

Schedule 1 Main improvements

Part 12 Notification of new information

Agricultural and Veterinary Chemicals Legislation Amendment

(Australian Pesticides and Veterinary Medicines Authority Board and

Other Improvements) Bill 2019

No. , 2019

or (c) the holder of the approval of a label for containers for a

chemical product;

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

Omit "or in relation to the product or of any of its constituents",

substitute ", in relation to the product or of any of its constituents or in

relation to the label".

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

Omit "relevant information", substitute "relevant information".

87 Paragraph 161(2)(a) of the Code set out in the Schedule

After "product", insert "or in the relevant APVMA file for the label".

88 At the end of paragraph 161(2)(b) of the Code set out in

the Schedule

Add "or that the label may not meet the labelling criteria".

89 Application provisions

(1)

The amendments of section 160A of the Code set out in the Schedule to

the Agricultural and Veterinary Chemicals Code Act 1994 made by this

Part apply in relation to applications lodged on or after the

commencement of this item.

(2)

The amendments of section 161 of the Code set out in the Schedule to

the Agricultural and Veterinary Chemicals Code Act 1994 made by this

Part apply in relation to information a holder becomes aware of on or

after the commencement of this item (whether the approval of the label

was given before, on or after that commencement).

Main improvements Schedule 1

Annual operational plans Part 13

No. , 2019

Agricultural and Veterinary Chemicals Legislation Amendment

(Australian Pesticides and Veterinary Medicines Authority Board and

Other Improvements) Bill 2019

Part 13--Annual operational plans

Agricultural and Veterinary Chemicals (Administration) Act

1992

90 Part 6 (heading)

Repeal the heading, substitute:

Part 6--Corporate plan

91 Sections 55, 56 and 57

Repeal the sections.

92 Paragraph 61(a)

Repeal the paragraph.

93 Paragraph 61(b)

Repeal the paragraph, substitute:

(b) an evaluation of the APVMA's overall performance during

that period against the performance indicators (if any)

prescribed by the regulations for the purposes of this

paragraph; and

94 Paragraph 61(d)

Repeal the paragraph.

95 Application and transitional provisions

(1)

The amendments made by this Part apply in relation to the calendar year

beginning on the day this item commences and each later calendar year.

(2)

Despite the amendments made by this Part, sections 55 to 57 of the

Agricultural and Veterinary Chemicals (Administration) Act 1992, as in

force immediately before the commencement of this item, continue to

apply on and after that commencement in relation to an annual

Schedule 1 Main improvements

Part 13 Annual operational plans

Agricultural and Veterinary Chemicals Legislation Amendment

(Australian Pesticides and Veterinary Medicines Authority Board and

Other Improvements) Bill 2019

No. , 2019

operational plan relating to the period of 12 months beginning on 1 July

of the financial year in which this item commences.

(3)

Despite the amendments made by this Part, section 61 of the

Agricultural and Veterinary Chemicals (Administration) Act 1992, as in

force immediately before the commencement of this item, continues to

apply on and after that commencement in relation to the period of 12

months beginning on 1 July of the financial year in which this item

commences.

(4)

Regulations in force for the purposes of subparagraph 61(b)(ii) of the

Agricultural and Veterinary Chemicals (Administration) Act 1992

immediately before the commencement of this item continue in force,

on and after that commencement, for the purposes of paragraph 61(b) of

that Act.

Main improvements Schedule 1

Definition of registered chemical product Part 14

No. , 2019

Agricultural and Veterinary Chemicals Legislation Amendment

(Australian Pesticides and Veterinary Medicines Authority Board and

Other Improvements) Bill 2019

Part 14--Definition of registered chemical product

Agricultural and Veterinary Chemicals Code Act 1994

96 Section 3 of the Code set out in the Schedule (definition of

registered chemical product)

Repeal the definition, substitute:

registered chemical product has the meaning given by

section 5AA.

97 After section 5 of the Code set out in the Schedule

Insert:

5AA Definition of registered chemical product

(1) A registered chemical product is a chemical product:

(a) that is registered; and

(b) that complies with the relevant particulars entered in the

Constituents of the chemical product

(2) If:

(a) a chemical product is registered; and

(b) under regulations made for the purposes of

paragraph 20(1)(c), a relevant particular (the subject

particular) required to be entered in the Register in relation

to the chemical product is the constituents of the chemical

product; and

paragraph 83(1)(a) in relation to the chemical product; and

(d) the constituents of the chemical product do not differ by

more than the extent prescribed for the purposes of

paragraph 83(1)(a);

then, for the purposes of paragraph (1)(b) of this section, the

chemical product is taken to comply with the subject particular.

Schedule 1 Main improvements

Part 14 Definition of registered chemical product

Agricultural and Veterinary Chemicals Legislation Amendment

(Australian Pesticides and Veterinary Medicines Authority Board and

Other Improvements) Bill 2019

No. , 2019

Concentration of constituents of the chemical product

(3) If:

(a) a chemical product is registered; and

(b) under regulations made for the purposes of

paragraph 20(1)(c), a relevant particular (the subject

particular) required to be entered in the Register in relation

to the chemical product is the concentration of one or more

constituents of the chemical product; and

paragraph 83(1)(b) in relation to the chemical product; and

(d) the concentration of the constituents of the chemical product

does not differ by more than the extent prescribed for the

purposes of paragraph 83(1)(b);

then, for the purposes of paragraph (1)(b) of this section, the

chemical product is taken to comply with the subject particular.

Composition of constituents of the chemical product

(4) If:

(a) a chemical product is registered; and

(b) under regulations made for the purposes of

paragraph 20(1)(c), a relevant particular (the subject

particular) required to be entered in the Register in relation

to the chemical product is the composition of a constituent of

the chemical product; and

paragraph 83(1)(c) in relation to the composition of that

constituent of the chemical product; and

(d) the composition of that constituent of the chemical product

does not differ by more than the extent prescribed for the

purposes of paragraph 83(1)(c);

then, for the purposes of paragraph (1)(b) of this section, the

chemical product is taken to comply with the subject particular.

Purity of constituents of the chemical product

(5) If:

(a) a chemical product is registered; and

Main improvements Schedule 1

Definition of registered chemical product Part 14

No. , 2019

Agricultural and Veterinary Chemicals Legislation Amendment

(Australian Pesticides and Veterinary Medicines Authority Board and

Other Improvements) Bill 2019

(b) under regulations made for the purposes of

paragraph 20(1)(c), a relevant particular (the subject

particular) required to be entered in the Register in relation

to the chemical product is the purity of a constituent of the

chemical product; and

paragraph 83(1)(c) in relation to the purity of that constituent

of the chemical product; and

(d) the purity of that constituent of the chemical product does not

differ by more than the extent prescribed for the purposes of

paragraph 83(1)(c);

then, for the purposes of paragraph (1)(b) of this section, the

chemical product is taken to comply with the subject particular.

Schedule 1 Main improvements

Part 15 Supply of registered chemical products with unapproved label

Agricultural and Veterinary Chemicals Legislation Amendment

(Australian Pesticides and Veterinary Medicines Authority Board and

Other Improvements) Bill 2019

No. , 2019

Part 15--Supply of registered chemical products

with unapproved label

Agricultural and Veterinary Chemicals Code Act 1994

98 Subparagraph 81(1)(a)(i) of the Code set out in the

Schedule

Omit "relevant particulars", substitute "minimum information (see

subsection (5))".

99 Subparagraph 81(1)(a)(ii) of the Code set out in the

Schedule

Omit "the relevant particulars", substitute "the minimum information".

100 Paragraph 81(2)(a) of the Code set out in the Schedule

Omit "relevant particulars", substitute "minimum information (see

subsection (5))".

101 Paragraph 81(2)(b) of the Code set out in the Schedule

Omit "the relevant particulars", substitute "the minimum information".

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

Schedule

Repeal the paragraphs, substitute:

(a) the label attached to the container states the minimum

information (the earlier information) that was required to be

stated on a label for containers for the product at a time

before the supply takes place; and

(b) the earlier information is different from the minimum

information that is required to be stated on a label for

containers for the product at the time the supply takes place;

and

respect of the earlier information; and

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(d) the supply takes place not later than 2 years (or such shorter

or longer period as the APVMA allows) after the earlier

information ceased to be the minimum information that was

required be stated on a label for containers for the product.

103 At the end of section 81 of the Code set out in the

Schedule

Add:

(5) For the purposes of this section, the minimum information is the

information covered by subparagraphs 21(c)(iii) and (iv) (including

that information as varied under Part 2).

104 Application provision

The amendments of section 81 of the Code set out in the Schedule to the

Agricultural and Veterinary Chemicals Code Act 1994 made by this

Part apply in relation to supplies occurring on or after the

commencement of this item.

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Part 16--Safety, efficacy, trade and labelling criteria

Agricultural and Veterinary Chemicals Code Act 1994

105 At the end of subsection 5D(2) of the Code set out in the

Schedule

Add:

; (d) any matters prescribed by the regulations.

106 After section 5D of the Code set out in the Schedule

Insert:

5E Overseas trials and experiments

Without limiting subparagraph 5A(2)(a)(vii) or (3)(a)(vii) or

paragraph 5B(2)(d), 5C(2)(c) or 5D(2)(d) and despite section 160,

the matters prescribed by regulations made for the purposes of that

subparagraph or paragraph may relate to matters covered by

paragraph 160(2)(a), (b) or (c).

107 Application provision

The amendment of section 5D of the Code set out in the Schedule to the

Agricultural and Veterinary Chemicals Code Act 1994 made by this

Part applies in relation to deciding, on or after the commencement of

this item, whether a label for containers for a chemical product meets

the labelling criteria.

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Part 17--Maximum Residue Limits Standard

Agricultural and Veterinary Chemicals (Administration) Act

1992

108 Section 7A (heading)

Omit "Annual publication", substitute "Approval".

109 Subsection 7A(1)

Repeal the subsection, substitute:

(1) The APVMA must, by legislative instrument, approve standards

for residues of chemical products in protected commodities.

Agricultural and Veterinary Chemicals Code Act 1994

110 Subparagraph 8E(2)(b)(i) of the Code set out in the

Schedule

Repeal the subparagraph, substitute:

(i) the names, or proposed names, of the active constituents

concerned; and

111 Paragraph 8E(2)(c) of the Code set out in the Schedule

Repeal the paragraph, substitute:

approval, registration, variation or permit is given, made or

issued.

112 Application provision

The amendments of section 8E of the Code set out in the Schedule to

the Agricultural and Veterinary Chemicals Code Act 1994 made by this

Part apply in relation to notices given on or after the commencement of

this item.

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Part 18 Expiry date

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Part 18--Expiry date

Agricultural and Veterinary Chemicals Code Act 1994

113 Section 3 of the Code set out in the Schedule (definition

of expiry date)

Omit "should", substitute "must".

114 Application provision

The amendment made by this Part applies in relation to a supply

referred to in subsection 85(1) or 91(1) or (2) of the Code set out in the

Schedule to the Agricultural and Veterinary Chemicals Code Act 1994

that occurs on or after the commencement of this item.

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Part 19--Other amendments

Agricultural and Veterinary Chemicals (Administration) Act

1992

115 Paragraph 7(1A)(a)

Omit "sale", substitute "supply".

116 Paragraphs 8A(2)(a) and (b)

Omit "whether to grant".

117 Subsection 58(7)

Repeal the subsection.

118 Subsection 69D(1)

After "fee (if any)", insert "to the Commonwealth".

119 After subsection 69D(1A)

Insert:

(1AA) The APVMA may, on its own initiative, reconsider a decision of

the APVMA to refuse to give a certificate under subsection (1).

(1AB) If the APVMA reconsiders the decision, it must:

(a) confirm the decision; or

(b) set aside the decision and give the certificate.

(1AC) The APVMA must give notice of a thing done under

subsection (1AB) to the person who applied for the certificate.

120 Part 7B

Repeal the Part.

121 Subsection 72(5)

Repeal the subsection, substitute:

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(5) The Minister must cause a copy of the report of the review to be

tabled in each House of the Parliament within 15 sitting days of

that House after the Minister receives the report.

122 Sections 78, 79 and 80

Repeal the sections.

123 Application and saving provisions

(1)

Subsections 69D(1AA) to (1AC) of the Agricultural and Veterinary

Chemicals (Administration) Act 1992, as inserted by this Part, apply in

relation to decisions made on or after the commencement of this item.

(2)

Despite the repeal of Part 7B of the Agricultural and Veterinary

Chemicals (Administration) Act 1992 made by this Part, section 69EZ

of that Act, as in force immediately before the commencement of this

item, continues to apply on and after that commencement in relation to

an approval referred to in that section that was given before that

commencement.

Agricultural and Veterinary Chemicals Code Act 1994

124 After section 6E of the Code set out in the Schedule

Insert:

6F Specification by class

To avoid doubt, a reference in this Code to a class or kind of matter

or thing does not, by implication, affect the application of:

(a) subsection 13(3) of the Legislation Act 2003; or

(b) subsection 33(3AB) of the Acts Interpretation Act 1901.

125 Subparagraph 8A(a)(v) of the Code set out in the

Schedule

Omit "subparagraph.", substitute "subparagraph; and".

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126 Subparagraph 14A(1)(a)(ii) of the Code set out in the

Schedule

Omit "United States Pharmacopoeia", substitute "United States

Pharmacopeia".

127 Subsection 46(1) of the Code set out in the Schedule

Omit "relevant file", substitute "relevant APVMA file".

128 Paragraph 51(c) of the Code set out in the Schedule

Omit "relevant file", substitute "relevant APVMA file".

129 Paragraph 74(1)(c) of the Code set out in the Schedule

Omit "permit; or", substitute "permit.".

130 Paragraph 74(1)(d) of the Code set out in the Schedule

Repeal the paragraph.

131 Subsection 74(2) of the Code set out in the Schedule

Repeal the subsection.

132 Subsection 74(2A) of the Code set out in the Schedule

(note)

Omit "(d)", substitute "(c)".

133 Subsection 74(3A) of the Code set out in the Schedule

(note 2)

Omit "(d)", substitute "(c)".

134 Subsection 74(4) of the Code set out in the Schedule

Repeal the subsection.

135 Paragraph 75(1)(b) of the Code set out in the Schedule

Omit "section; or", substitute "section.".

136 Paragraph 75(1)(c) of the Code set out in the Schedule

Repeal the paragraph.

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137 Subsection 75(2) of the Code set out in the Schedule

Repeal the subsection.

138 Subsection 75(2A) of the Code set out in the Schedule

(note)

Omit "to (c)", substitute "and (b)".

139 Subsection 75(3A) of the Code set out in the Schedule

(note 2)

Omit "to (c)", substitute "and (b)".

140 Subsection 75(4) of the Code set out in the Schedule

Repeal the subsection.

141 Paragraph 76(1)(b) of the Code set out in the Schedule

Omit "permit; or", substitute "permit.".

142 Paragraph 76(1)(c) of the Code set out in the Schedule

Repeal the paragraph.

143 Subsection 76(2) of the Code set out in the Schedule

Repeal the subsection.

144 Subsection 76(2A) of the Code set out in the Schedule

(note)

Omit "to (c)", substitute "and (b)".

145 Subsection 76(3A) of the Code set out in the Schedule

(note 2)

Omit "to (c)", substitute "and (b)".

146 Subsection 76(4) of the Code set out in the Schedule

Repeal the subsection.

147 Paragraph 78(1)(b) of the Code set out in the Schedule

Omit "section; or", substitute "section.".

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148 Paragraph 78(1)(c) of the Code set out in the Schedule

Repeal the paragraph.

149 Subsection 78(2) of the Code set out in the Schedule

Repeal the subsection.

150 Subsection 78(2A) of the Code set out in the Schedule

(note)

Omit "to (c)", substitute "and (b)".

151 Subsection 78(3A) of the Code set out in the Schedule

(note 2)

Omit "to (c)", substitute "and (b)".

152 Subsection 78(4) of the Code set out in the Schedule

Repeal the subsection.

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

Omit "suspend or cancel the approval, or suspend or cancel the

registration, as the case may be", substitute "suspend or cancel the

permit".

154 Subsections 166(3) and (4) of the Code set out in the

Schedule

Repeal the subsections, substitute:

(3) If a request is so made, the APVMA must reconsider the original

decision having regard only to the information used to make it.

(4) The APVMA may, on its own initiative, reconsider the original

decision having regard only to the information used to make it.

(4A) If, under subsection (3) or (4), the APVMA reconsiders the original

decision, the APVMA must:

(a) confirm the original decision; or

(b) vary the original decision; or

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(d) set aside the original decision and make a new decision in

substitution for the original decision.

(4B) The APVMA must, as soon as practicable, give written notice

setting out the APVMA's decision on the reconsideration to:

(a) for a reconsideration under subsection (3)--the person who

made the request; or

(b) for a reconsideration under subsection (4)--each person

whose interests are affected by that decision of whom the

APVMA is aware.

155 Subsection 166(6) of the Code set out in the Schedule

Omit "If the APVMA has not given notice under subsection (4)",

substitute "For a reconsideration under subsection (3), if the APVMA

has not given notice under subsection (4B)".

156 Paragraph 167(1)(i) of the Code set out in the Schedule

Repeal the paragraph.

157 Sections 180, 183 and 184 of the Code set out in the

Schedule

Repeal the sections.

158 Application provision

The amendments of section 166 of the Code set out in the Schedule to

the Agricultural and Veterinary Chemicals Code Act 1994 made by this

Part apply in relation to original decisions made on or after the

commencement of this item.

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Part 20--Repeals

Agricultural and Veterinary Chemicals Legislation

Amendment (Removing Re-approval and

Re-registration) Act 2014

159 The whole of the Act

Repeal the Act.

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Schedule 2--Australian Pesticides and

Veterinary Medicines Authority Board

Agricultural and Veterinary Chemicals (Administration) Act

1992

1 Section 4 (definition of Advisory Board)

Repeal the definition.

2 Section 4

Insert:

appointed Board member means a Board member other than the

Chief Executive Officer.

Board means the Board of the APVMA established by section 14.

3 Section 4 (definition of Board member)

Repeal the definition, substitute:

Board member means a member of the Board.

4 Section 4 (definition of Chair)

Repeal the definition, substitute:

Chair means the Chair of the Board.

5 Section 4

Insert:

paid work means work for financial gain or reward (whether as an

employee, a self-employed person or otherwise).

6 Subsection 8(3)

Repeal the subsection.

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7 Paragraph 10(2)(c)

Omit "Chief Executive Officer", substitute "Board".

8 Section 10A

Repeal the section.

9 Part 3 (heading)

Repeal the heading, substitute:

Part 3--Constitution of APVMA, the Board and

committees

10 Section 13

Repeal the section.

11 Divisions 2, 3 and 4 of Part 3

Repeal the Divisions, substitute:

Division 2--Board of the APVMA

Subdivision A--Establishment and functions of the Board

14 Establishment of the Board

The Board of the APVMA is established by this section.

15 Functions and powers of the Board

(1) The functions of the Board are:

(a) to ensure the proper, efficient and effective performance of

the APVMA's functions; and

(b) to determine objectives, strategies and policies to be followed

by the APVMA; and

of the functions referred to in paragraph (a) or (b).

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(2) In determining objectives, strategies and policies to be followed by

the APVMA, the Board must have regard to section 1A of the

Code set out in the Schedule to the Agricultural and Veterinary

Chemicals Code Act 1994.

(3) The Board has power to do all things necessary or convenient to be

done for or in connection with the performance of its functions.

16 Limitation on functions and powers of the Board

To avoid doubt, the functions and powers of the Board do not

include making decisions under any of the following:

(a) Part 7A, 7AA, 7AB or 8 of this Act;

(b) the Code set out in the Schedule to the Agricultural and

Veterinary Chemicals Code Act 1994;

Chemicals Code Act 1994;

(d) the Agricultural and Veterinary Chemicals Act 1994;

(e) the Agricultural and Veterinary Chemical Products

(Collection of Levy) Act 1994.

Subdivision B--Board members

17 Membership of the Board

The Board consists of the following members:

(a) the Chair;

(b) the Chief Executive Officer;

18 Appointment of appointed Board members

(1) The appointed Board members are to be appointed by the Minister

by written instrument, on a part-time basis.

Note:

An appointed Board member may be reappointed: see section 33AA

of the Acts Interpretation Act 1901.

(2) A person must not be appointed as an appointed Board member

unless the Minister is satisfied that the person has appropriate

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qualifications, skills or experience in one or more of the following

fields:

(a) financial management;

(b) law;

(d) public sector governance;

(e) science (including agricultural science and veterinary

science);

(f) public health or occupational health and safety.

(3) In appointing the appointed Board members, the Minister must

ensure, to the extent practicable, that the appointed Board members

are an appropriate mix of persons with the qualifications, skills or

experience referred to in subsection (2).

19 Term of appointment

(1) An appointed Board member holds office for the period specified

in the instrument of appointment. The period must not exceed 4

years.

(2) The appointed Board member is eligible to be reappointed on one

occasion after the appointed Board member's first appointment.

20 Acting Board members

Acting as the Chair

(1) The Minister may, by written instrument, appoint an appointed

Board member to act as the Chair:

(a) during a vacancy in the office of Chair, whether or not an

appointment has previously been made to the office; or

(b) during any period, or during all periods, when the Chair:

(i) is absent from duty or from Australia; or

(ii) is, for any reason, unable to perform the duties of the

office.

Note:

For rules that apply to acting appointments, see sections 33AB and

33A of the Acts Interpretation Act 1901.

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Acting as an appointed Board member (except the Chair)

(2) The Minister may, by written instrument, appoint a person to act as

an appointed Board member (except the Chair):

(a) during a vacancy in the office of an appointed Board member

(except the Chair), whether or not an appointment has

previously been made to the office; or

(b) during any period, or during all periods, when an appointed

Board member (except the Chair):

(i) is absent from duty or from Australia; or

(ii) is, for any reason, unable to perform the duties of the

office.

Note:

For rules that apply to acting appointments, see sections 33AB and

33A of the Acts Interpretation Act 1901.

(3) A person is not eligible for appointment under subsection (2)

unless the Minister is satisfied that the person has appropriate

qualifications, skills or experience in one or more of the fields

referred to in subsection 18(2).

21 Remuneration

(1) An appointed Board member is to be paid the remuneration that is

determined by the Remuneration Tribunal. If no determination of

that remuneration by the Tribunal is in operation, the member is to

be paid the remuneration that is prescribed by the regulations.

(2) An appointed Board member is to be paid the allowances that are

prescribed by the regulations.

(3) This section has effect subject to the Remuneration Tribunal Act

1973.

22 Paid work

An appointed Board member must not engage in any paid work

that, in the Minister's opinion, conflicts or could conflict with the

proper performance of the member's duties.

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23 Leave of absence

(1) The Minister may grant leave of absence to the Chair on the terms

and conditions that the Minister determines.

(2) The Chair may grant leave of absence to any other appointed

Board member on the terms and conditions that the Chair

determines.

24 Resignation of appointment

(1) An appointed Board member may resign the member's

appointment by giving the Minister a written resignation.

(2) The resignation takes effect on the day it is received by the

Minister or, if a later day is specified in the resignation, on that

later day.

25 Termination of appointment

The Minister may terminate the appointment of an appointed

Board member:

(a) for misbehaviour; or

(b) if the appointed Board member is unable to perform the

duties of the member's office because of physical or mental

incapacity; or

(i) becomes bankrupt; or

(ii) applies to take the benefit of any law for the relief of

bankrupt or insolvent debtors; or

(iii) compounds with the member's creditors; or

(iv) makes an assignment of the member's remuneration for

the benefit of the member's creditors; or

(d) if the appointed Board member is absent, except on leave of

absence, from 3 consecutive meetings of the Board; or

(e) if the appointed Board member engages in paid work that, in

the Minister's opinion, conflicts or could conflict with the

proper performance of the member's duties (see section 22);

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(f) if the Minister is satisfied that the appointed Board member's

performance has been unsatisfactory.

Note:

The appointment of an appointed Board member may also be

terminated under section 30 of the Public Governance, Performance

and Accountability Act 2013 (which deals with terminating the

appointment of an accountable authority, or a member of an

accountable authority, for contravening general duties of officials).

26 Other terms and conditions

An appointed Board member holds office on the terms and

conditions (if any) in relation to matters not covered by this Act

that are determined by the Minister.

Subdivision C--Meetings of the Board

27 Convening meetings

(1) The Board must hold such meetings as are necessary for the

efficient performance of its functions.

(2) The Chair:

(a) may convene a meeting at any time; and

(b) must convene at least 4 meetings each calendar year; and

written request to do so from another Board member.

27A Presiding at meetings

(1) The Chair must preside at all meetings at which the Chair is

present.

(2) If the Chair is not present at a meeting, the other Board members

present must appoint one of themselves to preside.

27B Quorum

(1) At a meeting of the Board, a quorum is constituted by a majority of

Board members.

(2) However, if:

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(a) a Board member is required by rules made for the purposes

of section 29 of the Public Governance, Performance and

Accountability Act 2013 not to be present during the

deliberations, or to take part in any decision, of the Board

with respect to a particular matter; and

(b) when the Board member leaves the meeting concerned there

is no longer a quorum present;

the remaining Board members at the meeting constitute a quorum

for the purpose of any deliberation or decision at that meeting with

respect to that matter.

27C Voting at meetings

(1) A question arising at a meeting of the Board is to be determined by

a majority of the votes of the Board members present and voting.

(2) The person presiding at the meeting of the Board has a deliberative

vote and, if the votes are equal, a casting vote.

27D Conduct of meetings

The Board may, subject to this Subdivision, regulate proceedings

at its meetings as it considers appropriate.

Note:

Section 33B of the Acts Interpretation Act 1901 contains further

information about the ways in which Board members may participate

in meetings.

27E Minutes

(1) The Board must keep minutes of its meetings.

(2) The Board must give the Secretary of the Department a copy of the

minutes, and the Board papers, from each meeting within 20

business days of the meeting.

27F Decisions without meetings

(1) The Board is taken to have made a decision at a meeting if:

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(a) without meeting, a majority of the Board members entitled to

vote on the proposed decision indicate agreement with the

decision; and

(b) that agreement is indicated in accordance with the method

determined by the Board under subsection (2); and

decision, or reasonable efforts were made to inform all the

Board members of the proposed decision.

(2) Subsection (1) applies only if the Board:

(a) has determined that it may make decisions of that kind

without meeting; and

(b) has determined the method by which Board members are to

indicate agreement with proposed decisions.

(3) For the purposes of paragraph (1)(a), a Board member is not

entitled to vote on a proposed decision if the Board member would

not have been entitled to vote on that proposal if the matter had

been considered at a meeting of the Board.

(4) The Board must keep a record of decisions made in accordance

with this section.

(5) The Board must give the Secretary of the Department details of

each decision made in accordance with this section within 20

business days of the decision being made.

Subdivision D--Minister may give directions to the Board

27G Minister may give directions to the Board

(1) The Minister may give written directions to the Board about the

performance of its functions or the exercise of its powers.

(2) The Board must comply with a direction under subsection (1).

(3) Subsection (2) does not apply to the extent that the direction relates

to the Board's performance of functions or exercise of powers

under the Public Governance, Performance and Accountability Act

2013 in relation to the APVMA.

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(4) The Minister must not give a direction to the Board unless:

(a) the Minister has given the Board a written notice stating that

the Minister is considering giving the direction; and

(b) the Minister has given the Board an adequate opportunity to

discuss with the Minister the need for the proposed direction.

(5) A direction under subsection (1) is a notifiable instrument.

(6) The Minister must cause a copy of a direction under subsection (1)

to be laid before each House of the Parliament within 15 sitting

days of giving the direction.

Subdivision E--Board to give documents to Secretary

27H Board to give documents to Secretary

The Board must give the Secretary of the Department a copy of

each document requested by the Secretary of the Department

within 20 business days of the request being made.

Subdivision F--Board committees

27J Board committees

(1) The Board may establish committees to assist it in the performance

of its functions or the exercise of its powers, and may abolish any

such committee.

(2) A committee is to consist of such persons (whether Board members

or not) as the Board determines.

(3) The Board may determine:

(a) the committee's terms of reference; and

(b) the terms and conditions of appointment of the members of

the committee; and

(4) The members of the committee (other than Board members) are not

officials for the purposes of the Public Governance, Performance

and Accountability Act 2013.

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Subdivision G--Review of the Board

27K Review of the Board

(1) The Minister must cause a review to be conducted of the functions

and operation of the Board.

(2) The review must be completed before the end of the period of 4

years beginning on the day this section commences.

(3) At any time after the review referred to in subsection (1) is

completed, the Minister may cause a review to be conducted of the

functions and operation of the Board.

(4) The person undertaking a review under this section must give the

Minister a written report of the review.

(5) The Minister must cause a copy of the report to be tabled in each

House of the Parliament within 15 sitting days of that House after

the report is given to the Minister.

12 Division 5 of Part 3 (heading)

Repeal the heading, substitute:

Division 5--APVMA committees

13 Subsection 32(1)

Omit "to manage the affairs of the APVMA and in doing so", substitute

"responsible for the day-to-day management and decision making of the

APVMA and, in doing this".

14 At the end of section 32

Add:

(4) The Chief Executive Officer is to act in accordance with the

objectives, strategies and policies determined by the Board under

paragraph 15(1)(b).

Australian Pesticides and Veterinary Medicines Authority Board Schedule 2

No. , 2019

Agricultural and Veterinary Chemicals Legislation Amendment

(Australian Pesticides and Veterinary Medicines Authority Board and

Other Improvements) Bill 2019

(5) The Board may give written directions to the Chief Executive

Officer about the performance of the Chief Executive Officer's

duties.

(6) The Chief Executive Officer must comply with a direction under

subsection (5).

(7) Subsection (6) does not apply to the extent that the direction relates

to the Chief Executive Officer's performance of functions or

exercise of powers under the Public Service Act 1999 in relation to

the APVMA.

(8) The Board must not give a direction to the Chief Executive Officer

unless:

(a) the Board has given the Chief Executive Officer a written

notice stating that the Board is considering giving the

direction; and

(b) the Board has given the Chief Executive Officer an adequate

opportunity to discuss with the Board the need for the

proposed direction.

(9) A direction under subsection (5) is not a legislative instrument.

15 Section 32A

Repeal the section.

16 Subsection 33(1)

Omit "Minister", substitute "Board".

17 After subsection 33(1)

Insert:

(1A) Before appointing the Chief Executive Officer, the Board must

consult the Minister.

18 Subsection 33(2)

Omit "A Board member", substitute "An appointed Board member".

Schedule 2 Australian Pesticides and Veterinary Medicines Authority Board

Agricultural and Veterinary Chemicals Legislation Amendment

(Australian Pesticides and Veterinary Medicines Authority Board and

Other Improvements) Bill 2019

No. , 2019

19 Section 34

Omit "Minister", substitute "Board".

20 Subsections 35(1) and (2)

Omit "Minister", substitute "Board".

21 Section 37

Omit "Minister", substitute "Board".

22 Section 38 (heading)

Omit "paid employment", substitute "paid work".

23 Section 38

Omit "paid employment", substitute "paid work".

24 Section 38

Omit "Minister", substitute "Board".

25 Sections 40 and 41

Omit "Minister" (wherever occurring), substitute "Board".

26 Section 41A

Omit "The Minister", substitute "(1) The Board".

27 Paragraph 41A(a)

Repeal the paragraph, substitute:

(a) for misbehaviour; or

(aa) if the Chief Executive Officer is unable to perform the duties

of the Chief Executive Officer's office because of physical or

mental incapacity; or

28 Paragraph 41A(d)

Omit "Minister's", substitute "Board's".

29 Paragraph 41A(d)

Omit "paid employment", substitute "paid work".

Australian Pesticides and Veterinary Medicines Authority Board Schedule 2

No. , 2019

Agricultural and Veterinary Chemicals Legislation Amendment

(Australian Pesticides and Veterinary Medicines Authority Board and

Other Improvements) Bill 2019

30 Paragraph 41A(f)

Omit "Minister", substitute "Board".

31 At the end of section 41A

Add:

(2) Before terminating the appointment of the Chief Executive Officer,

the Board must consult the Minister.

32 Subsection 42(1)

Omit "Minister", substitute "Board".

33 Subsection 43(1)

Omit "Minister", substitute "Board".

34 After subsection 43(1)

Insert:

(2) Before appointing a person to act as Chief Executive Officer, the

Board must consult the Minister.

35 Subsections 51(1) and (3)

Omit "Chief Executive Officer", substitute "Board".

36 Subsections 52(1), (2) and (3)

Omit "Chief Executive Officer", substitute "Board".

37 Section 61

Omit "Chief Executive Officer", substitute "Board".

38 At the end of section 61

Add:

; and (g) any directions given to the Board by the Minister during that

period and the impact of the directions on the operations of

the APVMA.

Schedule 2 Australian Pesticides and Veterinary Medicines Authority Board

Agricultural and Veterinary Chemicals Legislation Amendment

(Australian Pesticides and Veterinary Medicines Authority Board and

Other Improvements) Bill 2019

No. , 2019

39 Paragraph 69EP(7)(a)

Omit ", or the Chief Executive Officer,".

40 Transitional provision

--meetings of the Board

Paragraph 27(2)(b) of the Agricultural and Veterinary Chemicals

(Administration) Act 1992, as substituted by this Schedule, does not

apply in relation to the calendar year in which this item commences.

41 Application provision

--Chief Executive Officer

The amendments of sections 33 to 43 of the Agricultural and Veterinary

Chemicals (Administration) Act 1992 made by this Schedule apply in

relation to each appointment (including reappointment) of the Chief

Executive Officer on or after the commencement of this item.

42 Application and saving provisions

--corporate plans and

annual report

(1)

The amendments of section 51 of the Agricultural and Veterinary

Chemicals (Administration) Act 1992 made by this Schedule apply in

relation to each calendar year that begins after the commencement of

this item.

(2)

The amendments of Part 6 of the Agricultural and Veterinary

Chemicals (Administration) Act 1992 made by this Schedule do not

affect the validity of a corporate plan, or a variation of a corporate plan,

approved by the Minister before the commencement of this item.

(3)

The amendments of section 61 of the Agricultural and Veterinary

Chemicals (Administration) Act 1992 made by this Schedule apply in

relation to each reporting period (within the meaning of the Public

Governance, Performance and Accountability Act 2013) that ends after

the commencement of this item.

43 Transitional provision

--transfer of records and

documents of Advisory Board to the APVMA

(1)

This item applies to any records or documents that were in the

possession of the Advisory Board immediately before the

commencement of this item.

Australian Pesticides and Veterinary Medicines Authority Board Schedule 2

No. , 2019

Agricultural and Veterinary Chemicals Legislation Amendment

(Australian Pesticides and Veterinary Medicines Authority Board and

Other Improvements) Bill 2019

(2)

The records and documents are to be transferred to the APVMA after

the commencement of this item.

Note:

The records and documents transferred are Commonwealth records for the purposes of

the Archives Act 1983.

Commonwealth of Australia Bills

AGRICULTURAL AND VETERINARY CHEMICALS LEGISLATION AMENDMENT (AUSTRALIAN PESTICIDES AND VETERINARY MEDICINES AUTHORITY BOARD AND OTHER IMPROVEMENTS) BILL 2019