AGRICULTURAL AND VETERINARY CHEMICALS LEGISLATION AMENDMENT BILL 2013

2010-2011-2012

The Parliament of the

Commonwealth of Australia

HOUSE OF REPRESENTATIVES

Presented and read a first time

Agricultural and Veterinary Chemicals

Legislation Amendment Bill 2012

No. , 2012

(Agriculture, Fisheries and Forestry)

A Bill for an Act to amend laws relating to

agricultural and veterinary chemicals, and for

related purposes

i Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. , 2012

Contents

1 Short

title

...........................................................................................

2 Commencement

.................................................................................

3 Schedule(s)

........................................................................................

Review of operation of amendments ................................................. 2

Schedule 1--Approvals, registrations, permits and licences

Agricultural and Veterinary Chemicals Code Act 1994

Schedule 2--Re-approvals and re-registrations

Agricultural and Veterinary Chemicals Code Act 1994

Schedule 3--Enforcement

100

Agricultural and Veterinary Chemical Products (Collection of Levy)

Act 1994

100

Agricultural and Veterinary Chemicals (Administration) Act 1992

103

Agricultural and Veterinary Chemicals Code Act 1994

158

Schedule 4--Data protection

260

Agricultural and Veterinary Chemicals Code Act 1994

260

Schedule 5--Arrangements for collecting levy

276

Agricultural and Veterinary Chemical Products (Collection of Levy)

Act 1994

276

Schedule 6--Miscellaneous

283

Part 1--Miscellaneous amendments

283

Agricultural and Veterinary Chemical Products (Collection of Levy)

Act 1994

283

Agricultural and Veterinary Chemicals Act 1994

284

Agricultural and Veterinary Chemicals (Administration) Act 1992

285

Agricultural and Veterinary Chemicals Code Act 1994

287

Part 2--Transitional, application and savings provisions

290

Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. , 2012 1

A Bill for an Act to amend laws relating to

agricultural and veterinary chemicals, and for

related purposes

The Parliament of Australia enacts:

1 Short title

This Act may be cited as the Agricultural and Veterinary

Chemicals Legislation Amendment Act 2012.

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

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

according to its terms.

2 Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. ,

2012

Commencement information

Column 1

Column 2

Column 3

Provision(s) Commencement

Date/Details

1. Sections 1 to 4

and anything in

this Act not

elsewhere covered

by this table

The day this Act receives the Royal Assent.

2. Schedules 1 to

1 July 2013.

1 July 2013

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 Schedule(s)

Each Act 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.

4 Review of operation of amendments

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

(a) the operation of the amendments made by this Act; and

(b) any other related matter that the Minister specifies.

(2) At least one of the persons conducting the review must be a person

who is not otherwise appointed, employed or engaged by the

Commonwealth.

(3) The review must include a request for, and consideration of,

submissions from members of the public.

(4) The Minister must cause a written report of the review to be laid

before each House of the Parliament within 15 sitting days of that

House after 1 July 2018.

Approvals, registrations, permits and licences Schedule 1

Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. , 2012

Schedule 1--Approvals, registrations, permits

and licences

Agricultural and Veterinary Chemicals Code Act 1994

1 Before section 1 of the Code set out in the Schedule

Insert:

Division 1--Object, definitions etc.

2 After section 1 of the Code set out in the Schedule

Insert:

1A Implementing the Code

(1) This Code recognises that:

(a) the furthering of trade and commerce between Australia and

places outside Australia; and

(b) the present and future economic viability and

competitiveness of primary industry which relies on access to

chemical products and their constituents; and

chemical products and their constituents;

are essential for the well-being of the economy and require a

system for regulating chemical products and their constituents that

is cost effective, efficient, predictable, adaptive and responsive.

(2) This Code is to be implemented in a manner that:

(a) recognises that the health and safety of human beings,

animals and the environment is the first priority of the system

for regulating chemical products and their constituents, in

part to ensure that the use of chemical products at the present

time will not impair the prospects of future generations; and

(b) reflects established best-practice principles for the

assessment and management of risk, based on science; and

system of regulation on:

Schedule 1 Approvals, registrations, permits and licences

4 Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. ,

2012

(i) holders of approvals, registrations, permits and licences;

and

(ii) the domestic industry for manufacturing and

formulating chemical products and their constituents;

and

(iii) the users of chemical products;

with the risk of the use of the products and constituents to the

health and safety of human beings, animals and the

environment; and

(d) recognises that the use of chemical products that pose

unmanageable risks to the health and safety of human beings,

animals and the environment is not appropriate in Australia;

and

(e) promotes community confidence in the regulation of

chemical products and their constituents, is open and

accountable, and gives opportunity for public involvement

and participation; and

(f) secures compliance with this Code through appropriate,

proportionate, consistent and effective compliance and

enforcement measures.

3 Subsection 3(1) of the Code set out in the Schedule

(definition of acknowledge)

Repeal the definition.

4 Subsection 3(1) of the Code set out in the Schedule

(definition of adequate)

Omit all the words after "practicable, that the", substitute "product

meets the safety criteria, the trade criteria and the efficacy criteria".

5 Subsection 3(1) of the Code set out in the Schedule

Insert:

application means an application under this Code.

6 Subsection 3(1) of the Code set out in the Schedule

(definition of approved person)

Repeal the definition.

7 Subsection 3(1) of the Code set out in the Schedule

Approvals, registrations, permits and licences Schedule 1

Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. , 2012

Insert:

determine, in relation to an application, means:

(a) approve, re-approve, register, re-register, vary or issue on the

application; or

(b) refuse the application; or

approval or registration as required by section 29H--cancel

the approval or registration under section 34AA.

8 Subsection 3(1) of the Code set out in the Schedule

Insert:

electronic signature of a person means the unique identification of

the person in an electronic form approved by the APVMA.

9 Subsection 3(1) of the Code set out in the Schedule

(definition of established standard)

Repeal the definition, substitute:

established standard has the meaning given by subsection 8U(7).

10 Subsection 3(1) of the Code set out in the Schedule

(definition of holder)

Repeal the definition, substitute:

holder:

(a) in relation to an approval or registration, means:

(i) the person entered in the Record, Register or relevant

APVMA file as the holder of the approval or

registration; or

(ii) if the holder was an individual who has died or is an

individual whose affairs are being lawfully administered

by another person--the legal personal representative of

the individual or the person administering the

individual's affairs; or

(iii) if the holder was a body corporate--a successor in law

of the body corporate; or

(b) in relation to a permit or licence, means the person to whom

the permit or licence was issued.

Schedule 1 Approvals, registrations, permits and licences

6 Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. ,

2012

11 Subsection 3(1) of the Code set out in the Schedule

(definition of instructions for use)

Repeal the definition.

12 Subsection 3(1) of the Code set out in the Schedule

(definition of interested person)

Repeal the definition.

13 Subsection 3(1) of the Code set out in the Schedule

Insert:

limitation period has the meanings given by section 34M.

14 Subsection 3(1) of the Code set out in the Schedule

(definition of listable chemical product)

Repeal the definition.

15 Subsection 3(1) of the Code set out in the Schedule

Insert:

listed chemical product means a chemical product that is, or is

included in a class of chemical products that is, listed by

regulations under section 8T.

16 Subsection 3(1) of the Code set out in the Schedule

(definition of listed registration)

Repeal the definition.

17 Subsection 3(1) of the Code set out in the Schedule

(definition of Listing Schedule)

Repeal the definition.

18 Subsection 3(1) of the Code set out in the Schedule

Insert:

meets the application requirements has the meaning given by

section 8A.

meets the efficacy criteria has the meaning given by subsection

5B(1).

Approvals, registrations, permits and licences Schedule 1

Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. , 2012

meets the labelling criteria has the meaning given by subsection

5D(1).

meets the safety criteria has the meaning given by subsection

5A(1).

meets the trade criteria has the meaning given by subsection

5C(1).

19 Subsection 3(1) of the Code set out in the Schedule

Insert:

nominated agent, for an approval or registration, means the person

entered in the Record, Register or relevant APVMA file as the

nominated agent for the approval or registration.

20 Subsection 3(1) of the Code set out in the Schedule

Insert:

Record means the Record of Approved Active Constituents for

Chemical Products kept under section 17.

21 Subsection 3(1) of the Code set out in the Schedule

(definition of Record of Approved Active Constituents)

Repeal the definition.

22 Subsection 3(1) of the Code set out in the Schedule

Insert:

Register means the Register of Agricultural and Veterinary

Chemical Products kept under section 18.

23 Subsection 3(1) of the Code set out in the Schedule

(definition of Register of Chemical Products)

Repeal the definition.

24 Subsection 3(1) of the Code set out in the Schedule

(definition of registered listed chemical product)

Repeal the definition.

25 Subsection 3(1) of the Code set out in the Schedule

Schedule 1 Approvals, registrations, permits and licences

8 Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. ,

2012

Insert:

relevant APVMA file means the file in which information about

approved labels is recorded as mentioned in paragraph 21(c).

26 Subsection 3(1) of the Code set out in the Schedule

(definition of relevant particulars)

Repeal the definition, substitute:

relevant particulars means:

(a) in relation to the approval of an active constituent--the

distinguishing number, any instructions for use and any other

particulars required by paragraph 19(1)(c) to be entered in the

Record; and

(b) in relation to the registration of a chemical product--the

distinguishing number, any instructions for use and any other

particulars required by paragraph 20(1)(c) to be entered in the

required to be recorded in the relevant APVMA file by

subparagraphs 21(c)(i) to (iv);

and includes particulars of variations of relevant particulars made

under section 26, 26C, 29, 29A, 29G, 34A or 34AF.

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

Insert:

5A Definition of meets the safety criteria

(1) An active constituent or chemical product meets the safety criteria

if use of the constituent or product, in accordance with any

instructions approved, or to be approved, by the APVMA for the

constituent or product or contained in an established standard:

(a) is not, or would not be, an undue hazard to the safety of

people exposed to it during its handling or people using

anything containing its residues; and

(b) is not, or would not be, likely to have an effect that is harmful

to human beings; and

Approvals, registrations, permits and licences Schedule 1

Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. , 2012

that is harmful to animals, plants or things or to the

environment.

(2) For the purposes of being satisfied as to whether an active

constituent meets the safety criteria, the APVMA:

(a) must have regard to the following:

(i) the toxicity of the constituent and its residues in relation

to relevant organisms and ecosystems, including human

beings;

(ii) the method by which the constituent is, or is proposed to

be, manufactured;

(iii) the extent to which the constituent will contain

impurities;

(iv) whether an analysis of the chemical composition of the

constituent has been carried out and, if so, the results of

the analysis;

(v) any conditions to which its approval is, or would be,

subject;

(vi) any relevant particulars that are, or would be, entered in

the Record for the constituent;

(vii) any matters prescribed by the regulations; and

(b) may have regard to such other matters as it thinks relevant.

(3) For the purposes of being satisfied as to whether a chemical

product meets the safety criteria, the APVMA:

(a) must have regard to the following:

(i) the toxicity of the product and its residues in relation to

relevant organisms and ecosystems, including human

beings;

(ii) the relevant poison classification of the product under

the law in force in this jurisdiction;

(iii) how the product is formulated;

(iv) the composition and form of the constituents of the

product;

(v) any conditions to which its registration is, or would be,

subject;

(vi) any relevant particulars that are, or would be, entered in

the Register for the product;

Schedule 1 Approvals, registrations, permits and licences

10 Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. ,

2012

(vii) any matters prescribed by the regulations; and

(b) may have regard to one or more of the following:

(i) the acceptable daily intake of each constituent contained

in the product;

(ii) any dietary exposure assessment prepared under

subsection 82(4) of the Food Standards Australia New

Zealand Act 1991 as a result of any proposed variation

notified under subsection 82(3) of that Act in relation to

the product, and any comments on the assessment given

to the APVMA under subsection 82(4) of that Act;

(iii) whether any trials or laboratory experiments have been

carried out to determine the residues of the product and,

if so, the results of those trials or experiments and

whether those results show that the residues of the

product will not be greater than limits that the APVMA

has approved or approves;

(iv) the stability of the product;

(v) the specifications for containers for the product;

(vi) such other matters as it thinks relevant.

5B Definition of meets the efficacy criteria

(1) A chemical product meets the efficacy criteria if use of the

product, in accordance with instructions approved, or to be

approved, by the APVMA for the product, is, or would be,

effective according to criteria determined by the APVMA by

legislative instrument or contained in an established standard.

(2) For the purposes of being satisfied as to whether a chemical

product meets the efficacy criteria, the APVMA must have regard

to the following:

(a) whether any trials or laboratory experiments have been

carried out to determine the efficacy of the product and, if so,

the results of those trials or experiments;

(b) any conditions to which its registration is, or would be,

subject;

(d) any matters prescribed by the regulations.

Approvals, registrations, permits and licences Schedule 1

Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. , 2012

(3) For the purposes of the operation of this Code in relation to a

particular chemical product, the APVMA is required to have regard

to the matters set out in subsections (1) and (2) only:

(a) to the extent prescribed by the regulations; or

(b) if there are no such regulations--to the extent that the

APVMA thinks the matters are relevant.

5C Definition of meets the trade criteria

(1) A chemical product meets the trade criteria if use of the product,

in accordance with instructions approved, or to be approved, by the

APVMA or contained in an established standard, does not, or

would not, unduly prejudice trade or commerce between Australia

and places outside Australia.

(2) For the purposes of being satisfied as to whether a chemical

product meets the trade criteria, the APVMA must have regard to

the following:

(a) any conditions to which its registration is, or would be,

subject;

(b) any relevant particulars that are, or would be, entered in the

(3) For the purposes of the operation of this Code in relation to a

particular chemical product, the APVMA is required to have regard

to the matters set out in subsections (1) and (2) only:

(a) to the extent prescribed by the regulations; or

(b) if there are no such regulations--to the extent that the

APVMA thinks the matters are relevant.

5D Definition of meets the labelling criteria

(1) A label for containers for a chemical product meets the labelling

criteria if the label contains adequate instructions relating to such

of the following as are appropriate:

(a) the circumstances in which the product should be used;

(b) how the product should be used;

(d) the frequency of the use of the product;

Schedule 1 Approvals, registrations, permits and licences

12 Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. ,

2012

(e) the withholding period after the use of the product;

(f) the re-entry period after the use of the product;

(g) the disposal of the product when it is no longer required;

(h) the disposal of containers of the product;

(i) the safe handling of the product and first aid in the event of

an accident caused by the handling of the product;

(j) any matters prescribed by the regulations.

(2) For the purposes of being satisfied as to whether a label meets the

labelling criteria, the APVMA must have regard to the following:

(a) any conditions to which its approval is, or would be, subject;

(b) any relevant particulars and instructions that are, or would be,

entered in the relevant APVMA file for the label.

28 After section 6 of the Code set out in the Schedule

Insert:

6A APVMA may make guidelines etc.

(1) The APVMA may make written guidelines for performing its

functions and exercising its powers under this Code.

(2) The APVMA must have regard to the guidelines.

(3) The guidelines must include:

(a) principles and processes for effective and efficient regulation

of chemical products and their constituents; and

(b) principles and processes relating to:

(i) the approval of active constituents for proposed or

existing chemical products; and

(ii) the registration of chemical products; and

(iii) the approval of labels for containers for chemical

products; and

(iv) the variation of relevant particulars and conditions; and

(v) the issue of permits and licences.

(4) The guidelines must not be inconsistent with an agvet law.

(5) The APVMA must publish the guidelines on its website.

(6) The guidelines are not a legislative instrument.

Approvals, registrations, permits and licences Schedule 1

Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. , 2012

6B Varying relevant particulars and conditions

To avoid doubt, a power under this Code to vary a relevant

particular or condition does not authorise the APVMA to vary a

relevant particular or condition that was not imposed by the

APVMA.

6C Right of APVMA to use information

(1) The APVMA may use information obtained by it from any source

for the purpose of performing any of its functions or exercising any

of its powers under this Code.

(2) Subsection (1) has effect subject to this Code.

6D Failure to comply with time limit does not affect validity

Failure by the APVMA to comply with a time limit set out in this

Code does not affect the validity of anything done by the APVMA.

29 After section 8A of the Code set out in the Schedule

Insert:

Division 2--General provisions about applications

8A Definition of meets the application requirements

application

meets the application requirements if:

(a)

the

application:

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

(ii) is signed by the applicant; and

(iii) is accompanied by so much of the prescribed fee as is

required to be paid when the application is made; and

(iv) is lodged with the APVMA; and

(v) contains, or is accompanied by, any information

specified for the application under section 8B; and

(b) the constituent, product or label in relation to which the

application is made complies, or will comply, with any

requirement prescribed by the regulations; and

the application has been complied with; and

Schedule 1 Approvals, registrations, permits and licences

14 Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. ,

2012

(d) any requirement prescribed by another provision of this Code

in relation to the application has been complied with; and

(e) any amount (including an amount in respect of a tax or

penalty) that is payable by the applicant to the APVMA

(including under a law of another jurisdiction or the agvet

law), has been paid.

Note:

For giving information electronically, see section 156A.

8B Information to be provided with applications

(1) The APVMA may, by legislative instrument, specify the

information that must be contained in, or accompany, the

application.

(2) The APVMA may specify information under subsection (1) only

if:

(a) the inclusion of the information would enable the APVMA to

determine the application; and

(b) in relation to an application under section 29D (applications

for re-approval or re-registration)--the information is

information that the applicant could be reasonably expected

to have, or to have access to.

8C Information to be taken into account in determining applications

(1) In determining the application, the APVMA:

(a) must have regard to:

(i) the information in, or accompanying, the application as

required under section 8B or any other provision of this

Code; and

(ii) any information or thing given to the APVMA as

required under section 157 or 159 or by section 160A in

relation to the application; and

(iii) any submission made in response to an invitation given

by the APVMA in relation to the application; and

(b) may have regard to any other matter that it thinks relevant.

(2) However, the APVMA must not take into account any information

that:

(a) is given by or on behalf of the applicant in connection with

the application; but

Approvals, registrations, permits and licences Schedule 1

Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. , 2012

(b) is not covered by paragraph (1)(a).

(3) This section does not apply in relation to an application under

section 122 for a licence.

8D Applications may be withdrawn

At any time after the application is made and before it is

determined, the applicant may withdraw it by giving the APVMA

written notice of the withdrawal signed by the applicant.

Division 3--General provisions about notices

8E Notice to Food Standards Australia New Zealand

(1) The APVMA must notify Food Standards Australia New Zealand

if an approval, registration, variation or permit proposed under this

Code (whether by application or on the initiative of the APVMA)

would, if it were given, made or issued, be likely to require a

variation to the Maximum Residue Limits Standard.

(2) The notice must:

(a) be in writing; and

(b)

set

out:

(i) the relevant particulars, or proposed relevant particulars,

of the active constituents and products concerned, other

than confidential commercial information; and

(ii) any other matters that the APVMA thinks appropriate;

and

(i) for an application, other than an application under

section 29D--within 28 days after the APVMA

completes a preliminary assessment of the application;

(ii) for a variation under section 26C, 29, 29A, 29G, 34A or

34AF--before the variation is made.

(3) This section does not apply in relation to an approval, registration,

variation or permit proposed by an application that is subject to

preliminary assessment before the application has passed

preliminary assessment.

Schedule 1 Approvals, registrations, permits and licences

16 Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. ,

2012

8F Notice to holder of approval, registration or variation

(1) The APVMA must give written notice to the holder within 14 days

if the APVMA:

(a) approves (or re-approves) an active constituent; or

(b) registers (or re-registers) a chemical product; or

(d) approves a label; or

(e) varies relevant particulars or conditions (whether on

application or on the initiative of the APVMA), other than

under section 34A (varying relevant particulars or conditions

to allow affirmation).

Note:

For notices in relation to reconsiderations, see Division 4 of Part 2.

(2) The notice must:

(a) for an approval or registration:

(i) state that the constituent, product or label has been

approved or registered; and

(ii) set out the relevant particulars and conditions of the

approval or registration; and

(iii) state the date the approval or registration ends; and

(b) for a registration--state the date (if any) after which the

registration cannot be renewed under Division 6 of Part 2;

and

the chemical product has been renewed; and

(d) for the variation of relevant particulars or conditions:

(i) state that the relevant particulars or conditions have

been varied; and

(ii) set out the relevant particulars or conditions as varied;

and

(iii) state the date the approval or registration ends; and

(iv) of a registration--state the date (if any) after which the

registration cannot be renewed under Division 6 of

Part 2; and

(e) include any information prescribed by the regulations.

Approvals, registrations, permits and licences Schedule 1

Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. , 2012

8G Notice to applicant of refusal of application

(1) The APVMA must give written notice to the applicant within 14

days if the APVMA refuses an application.

Note:

For notices in relation to reconsiderations, see Division 4 of Part 2.

(2) The notice must:

(a) state that the application has been refused; and

(b) set out the reasons for the refusal; and

(d) specify any amount of fee that is repayable because of the

refusal.

Note:

Other provisions of this Code specify additional requirements for

certain notices of refusal.

8H Published notice of approvals and registrations

(1) If the APVMA approves an active constituent or registers a

chemical product, it must, unless it thinks that in the circumstances

it is unnecessary to do so, publish notice of the approval or

registration.

(2) The notice must:

(a) be published in the Gazette, as soon as practicable, and in any

other manner that the APVMA thinks appropriate; and

(b) state that the constituent has been approved or the product

has been registered and the date of the approval or

registration as mentioned in section 22; and

re-registration--state that fact; and

(d) contain a brief statement of the conditions of the approval or

registration that directly regulate the use of the constituent or

product; and

(e) include any information prescribed by the regulations.

8J Published notice of variations of approvals and registrations

(1) If the APVMA varies any of the relevant particulars or conditions

of the approval of an active constituent or the registration of a

chemical product, it must, unless it thinks that in the circumstances

it is unnecessary to do so, publish notice of the variation.

Schedule 1 Approvals, registrations, permits and licences

18 Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. ,

2012

(2) The notice must:

(a) be published in the Gazette, as soon as practicable, and in any

other manner that the APVMA thinks appropriate; and

(b) state that the relevant particulars or conditions have been

varied and the date on which the variation took place; and

variation; and

(d) include any information prescribed by the regulations.

8K Confidential commercial information in notices

Any provision of this Code that requires information (however

described) to be given in a notice has effect subject to section 162

(disclosure of confidential commercial information).

Division 4--Holders of approvals and registrations and

nominated agents

8L Changing the holder

(1) The holder of an approval or registration may apply to the

APVMA to change the holder.

(2) The APVMA must record the change in the Record, Register or

relevant APVMA file, as required, if the APVMA is satisfied that:

(a) the application meets the application requirements; and

(b) the proposed holder has consented, by signed writing, to

being the holder; and

on business in, Australia--there will be a nominated agent

for the approval or registration; and

(d) any requirements prescribed by the regulations have been

met.

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

Note:

For notice of refusal, see section 8G.

Approvals, registrations, permits and licences Schedule 1

Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. , 2012

8M Nominated agent

(1) The holder may, at any time, apply to the APVMA for the person

nominated in the application to be the nominated agent for the

approval or registration.

(2) The APVMA must record the person as the nominated agent in the

Record, Register or relevant APVMA file, as required, if the

APVMA is satisfied that:

(a) the application meets the application requirements; and

(b) the nominated person has consented, by signed writing, to

being the nominated agent; and

met.

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

Note:

For notice of refusal, see section 8G.

(4) It is a condition of the approval or registration that the nominated

agent is a resident of, or carries on business in, Australia.

8N Overseas holder must have nominated agent

If the holder is not a resident of, and does not carry on business in,

Australia, it is a condition of the approval or registration that there

is a nominated agent for the approval or registration.

8P Changing the nominated agent

(1) The holder may apply to the APVMA to change the nominated

agent.

(2) The APVMA must record the change in the Record, Register or

relevant APVMA file, as required, if the APVMA is satisfied that:

(a) the application meets the application requirements; and

(b) the person to be the nominated agent has consented, by

signed writing, to being the nominated agent; and

met.

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

Note:

For notice of refusal, see section 8G.

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20 Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. ,

2012

8Q Nominated agent may withdraw

(1) The nominated agent may, by signed writing given to the APVMA,

request to withdraw from being the nominated agent.

(2) The APVMA must record the withdrawal in the Record, Register

or relevant APVMA file, as required, if the APVMA is satisfied

that:

(a) the nominated agent has notified the holder of the

withdrawal; and

(b) any requirements prescribed by the regulations have been

met.

8R Role of nominated agent

Anything that may, or must, be done under this Code by, or in

relation to, the holder, as the holder of the approval or registration,

may be done by, or in relation to, either the holder or the

nominated agent.

Note:

For liabilities imposed on the nominated agent, see section 152.

Division 5--Notice of certain proposed decisions

8S Notice of certain proposed decisions

(1) The APVMA must give the applicant written notice of what it

proposes to do before it:

(a) refuses an application, other than on preliminary assessment;

(b) approves (or re-approves) or registers (or re-registers) an

active constituent, chemical product or label with instructions

or relevant particulars other than those set out in the

application; or

conditions--varies the relevant particulars or conditions

other than in accordance with the application.

Note:

For notices in relation to reconsiderations, see Division 4 of Part 2.

(2) The notice must:

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

instructions and relevant particulars; and

Approvals, registrations, permits and licences Schedule 1

Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. , 2012

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

variation; and

of action; and

(d) set out the information on which the reasons are based

(including information not given to the APVMA by the

applicant); and

(e) invite written submissions from the applicant within 28 days,

or within such further period as is specified in the notice.

(3) The APVMA is not required to take account of anything given in

response to the invitation under paragraph (2)(e) that is not related

to information:

(a) already given to the APVMA by, or on behalf of, the

applicant; or

(b) set out in the notice under paragraph (2)(d).

(4) The APVMA is not required to comply with this section more than

once in relation to a particular application.

Division 6--Listed chemical products and established

standards

8T Regulations may include schedule of listed chemical products

(1) The regulations may include a schedule specifying chemical

products, or classes of chemical products, that are listed chemical

products for the purposes of this Code.

(2) Before the Governor-General makes a regulation that includes, or

amends, the schedule referred to in subsection (1), the APVMA

must publish in the Gazette, and in any other manner that the

APVMA thinks appropriate, a notice:

(a) stating that it proposes to recommend to the Minister that the

regulation be made; and

(b) setting out particulars of the chemical products, or class of

chemical products, that would be covered, or otherwise

affected, by the regulation; and

under section 8U in relation to each chemical product that

would be covered by the regulation; and

Schedule 1 Approvals, registrations, permits and licences

22 Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. ,

2012

(d) giving the reasons for the proposed recommendation; and

(e) inviting any person, within a period of at least 28 days

specified in the notice, to make a written submission to the

APVMA as to whether the proposed regulation should be

made and stating the grounds on which the submission is

based, which must be grounds relating to the matters

mentioned in paragraph 8V(a).

(3) In making a recommendation to the Minister, the APVMA must

take into account any submissions made in accordance with the

invitation.

(4) Before the Governor-General makes a regulation that includes, or

amends, the schedule referred to in subsection (1):

(a) the APVMA must have recommended to the Minister that the

regulation be made; and

(b) the APVMA must have given to the Minister:

(i) its reasons for the recommendation; and

(ii) written particulars of the product or class of products

that would be covered, or otherwise affected, by the

regulation; and

(iii) a draft of the standard that the APVMA proposes to

make under section 8U for the product, or for products

in the class, if the product or class is specified in the

schedule; and

(iv) a written explanation as to why the APVMA is satisfied

that the product, or class of products, meets the safety

criteria, the trade criteria and the efficacy criteria (see

section 8V); and

(v) a written statement identifying the consultations held

by, and setting out the advice given to, the APVMA in

relation to the proposed regulation.

8U APVMA to prepare standards

(1) This section applies in respect of each listed chemical product,

whether or not the product is the subject of a monograph in the

British Pharmacopoeia or the British Pharmacopoeia (Veterinary)

or in a similar publication.

Approvals, registrations, permits and licences Schedule 1

Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. , 2012

(2) The APVMA must, by legislative instrument, make a standard for

each listed chemical product. A particular standard may relate to a

specified chemical product or specified chemical products or to

each chemical product in a specified class of chemical products.

(3) The standard for a listed chemical product must require that the

product be labelled in a manner, or kept in containers that comply

with requirements, specified in the standard.

(4) The APVMA may, in a standard, direct that the particulars required

by the standard be set out, in a manner specified in the standard,

on:

(a) chemical products, or a class of chemical products, identified

in the standard; or

(b) a container containing chemical products, or a class of

chemical products, identified in the standard; or

chemical products, identified in the standard.

(5) A standard for a listed chemical product:

(a) may be specified by reference to any one or more of the

following:

(i) the composition and form of the constituents of the

product;

(ii) the physical and chemical properties of the chemical

product;

(iii) the quantity of the chemical product when contained in

specified containers;

(iv) procedures to be carried out in the manufacture of the

chemical product;

(v) a monograph in the British Pharmacopoeia or the British

Pharmacopoeia (Veterinary);

(vi) a monograph in another publication approved by the

APVMA for the purposes of this subparagraph;

(vii) a monograph referred to in subparagraph (v) or (vi) as

modified in a manner specified in the standard;

(viii) a standard published by Standards Australia;

(ix) such other matters as the APVMA thinks fit; and

(b) may require that a matter relating to the standard be

determined in accordance with a particular test.

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24 Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. ,

2012

(6) Subsections (4) and (5) do not limit subsection (3).

(7) The standard made by the APVMA in relation to a listed chemical

product is the established standard for the product.

Note:

The APVMA may revoke or amend a standard. See subsection 33(3)

of the Acts Interpretation Act 1901.

8V Matters to be taken into account in preparing a standard

The APVMA must not make a standard for a listed chemical

product unless the APVMA is satisfied that compliance with the

standard would result in:

(a) the product meeting the safety criteria, the trade criteria and

the efficacy criteria; and

(b) any label for containers for the product meeting the labelling

criteria.

30 Section 9 of the Code set out in the Schedule

Repeal the section, substitute:

9 Explanation of Part

(1) This Part contains provisions relating to:

(a) approval of active constituents for proposed or existing

chemical products; and

(b) registration of chemical products; and

(2) Division 2 provides for approvals and registrations.

(3) Division 2A provides for variation of relevant particulars of

approvals and registrations if the relevant particulars are of a kind

set out in a legislative instrument made under section 26B. Only

holders of approvals or registrations may apply under Division 2A.

(4) Division 3 provides generally for variation of relevant particulars

or conditions of approvals and registrations. Holders and other

persons may apply under Division 3.

(5) Division 3A provides for re-approval and re-registration of active

constituents and chemical products.

Approvals, registrations, permits and licences Schedule 1

Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. , 2012

(6) Division 4 provides for the APVMA to reconsider approvals and

registrations in order to decide whether they should remain in

force.

(7) Division 4A limits the use the APVMA can make of certain

information given to it in connection with certain applications.

(8) Division 5 sets out the circumstances in which the APVMA may

suspend or cancel approvals and registrations.

(9) Division 6 states how long approvals and registrations are to

continue in force and makes provision for the renewal of

registrations.

31 Division 2 of Part 2 of the Code set out in the Schedule

(heading)

Repeal the heading, substitute:

Division 2--Approving and registering

32 Sections 10 to 14A of the Code set out in the Schedule

Repeal the sections, substitute:

9A Explanation of Division

(1) This Division provides for:

(a) approval of active constituents for proposed or existing

chemical products; and

(b) registration of chemical products; and

(2) Section 10 provides for applications to be made. Applications must

meet the application requirements specified in section 8A.

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

application. If the application passes preliminary assessment, the

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).

Schedule 1 Approvals, registrations, permits and licences

26 Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. ,

2012

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

(section 14). Sections 14A to 16 set out special rules about

approvals and registrations.

(6) The APVMA must keep a Record of Approved Active

Constituents for Chemical Products and a Register of Agricultural

and Veterinary Chemical Products (sections 17 and 18).

(7) Sections 19 to 21 set out how approvals and registrations take

place, and section 22 deals with dates of approval and registration.

(8) Approvals and registrations may be subject to conditions

(section 23).

(9) Section 26 provides for incorrect relevant particulars and

conditions of a kind prescribed by the regulations to be corrected.

10 Applications

(1) A person may apply to the APVMA:

(a) for approval of an active constituent for a proposed or

existing chemical product; or

(b) for registration of a chemical product; or

(2)

The

application:

(a) must meet the application requirements; and

(b) for an active constituent or chemical product--must include

proposed instructions for use of the constituent or product.

Note: For

meets the application requirements, see section 8A.

11 Preliminary assessment

(1) The APVMA must complete a preliminary assessment of the

application within 1 month after it is lodged.

(2) If it appears from the preliminary assessment that the application

meets the application requirements, the APVMA must, within 14

days:

(a) give written notice to the applicant:

Approvals, registrations, permits and licences Schedule 1

Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. , 2012

(i) stating that the application has passed preliminary

assessment and that it will be determined under

section 14; and

(ii) setting out any matters prescribed by the regulations;

and

(b) publish a summary of the application that includes any details

prescribed by the regulations.

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

Note:

For notice of refusal, see section 8G.

(4) The APVMA may alter the application, after it has passed

preliminary assessment, with the written consent of the applicant.

12 APVMA to publish notice before deciding whether to approve

new active constituent

(1) This section applies if the application:

(a) has passed preliminary assessment; and

(b) is for approval of an active constituent not previously

contained in a chemical product registered in this or another

jurisdiction under the Agvet Code, or a corresponding

previous law, of the jurisdiction concerned.

(2) The APVMA must publish a notice in the Gazette and in any other

manner that it thinks appropriate.

(3) The notice must state that the APVMA has to decide whether to

approve the constituent and must:

(a) set out the following:

(i) the name of the constituent;

(ii) particulars of the constituent;

(iii) a summary of the APVMA's assessment of whether the

constituent meets the safety criteria;

(iv) any other matters that the APVMA thinks appropriate;

and

(b) invite any person to make, within a specified period of at

least 28 days, a written submission as to whether the

constituent should be approved and stating the grounds on

which the submission is based, which must be grounds that

relate to the safety criteria.

Schedule 1 Approvals, registrations, permits and licences

28 Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. ,

2012

13 APVMA to publish notice before deciding whether to register

chemical product containing new active constituent

(1) This section applies if the application:

(a) has passed preliminary assessment; and

(b) is for registration of a chemical product containing an active

constituent not previously contained in a chemical product

registered in this or another jurisdiction under the Agvet

Code, or a corresponding previous law, of the jurisdiction

concerned.

(2) The APVMA must publish a notice in the Gazette and in any other

manner that it thinks appropriate.

(3) The notice must state that the APVMA has to decide whether to

(a) set out the following:

(i) the name that the applicant intends to use to describe the

product;

(ii) particulars of the product and its active constituents;

(iii) a summary of the APVMA's assessment of whether the

product meets the safety criteria, the trade criteria and

the efficacy criteria;

(iv) any other matters that the APVMA thinks appropriate;

and

(b) invite any person to make, within a specified period of at

least 28 days, a written submission to the APVMA as to

whether the product should be registered and stating the

grounds on which the submission is based, which must be

grounds that relate to the safety criteria, the trade criteria or

the efficacy criteria.

14 Approval and registration

(1) The APVMA must approve the active constituent or label, or

(a) that the application meets the application requirements; and

(b) for an active constituent--that the constituent meets the

safety criteria; and

Approvals, registrations, permits and licences Schedule 1

Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. , 2012

(i) meets the safety criteria, the trade criteria and the

efficacy criteria; or

(ii) complies with the established standard for the product;

and

(d) for a label for a chemical product--that the label:

(i) meets the labelling criteria; or

(ii) complies with the established standard for the product.

Note:

For notice of approval or registration, see section 8F.

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

Note:

For notice of refusal, see section 8G.

14A Approval of active constituents for which information is not

readily available

(1) The APVMA may approve an active constituent for a proposed or

existing chemical product if:

(a) either of the following applies:

(i) the APVMA considers that information it requires in

respect of the constituent is not readily available;

(ii) the constituent is, or is part of, a product in respect of

which a standard is specified in the European

Pharmacopoeia, the British Pharmacopoeia

(Veterinary), the United States Pharmacopoeia or any

other publication considered by the APVMA to be

appropriate; and

(b) having regard to information that is readily available, the

APVMA is satisfied that the constituent would meet the

safety criteria.

(2) Subsection (1) applies:

(a) despite subsection 14(2); and

(b) whether or not an application has been made for approval of

the constituent.

33 Section 14B of the Code set out in the Schedule (heading)

Repeal the heading, substitute:

Schedule 1 Approvals, registrations, permits and licences

30 Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. ,

2012

14B APVMA not to use information for registration of new chemical

product to register a similar product after disclosure

34 Paragraph 14B(1)(a) of the Code set out in the Schedule

Omit "an agricultural", substitute "a".

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

Repeal the paragraph, substitute:

(b) the information related to the first product or the active

constituent and:

(i) the safety criteria; or

(ii) a matter that is prescribed by the regulations; and

36 Paragraph 14B(1)(e) of the Code set out in the Schedule

Repeal the paragraph, substitute:

(e) as a result of the disclosure, the applicant for an application

for registration of a chemical product (the second product)

that is the same as, or similar to, the first product, seeks to

have the APVMA use the information in determining the

application.

37 Subsection 14B(2) of the Code set out in the Schedule

Omit "grant the application for registration of", substitute "register".

38 Subsection 14B(3) of the Code set out in the Schedule

Omit "granting", substitute "determining".

39 Subsection 14B(3) of the Code set out in the Schedule

Omit "of the grant or".

40 Section 15 of the Code set out in the Schedule (heading)

Repeal the heading, substitute:

15 Restriction on power of APVMA to register products and

approve labels

41 Paragraphs 15(1)(a) and (b) of the Code set out in the

Schedule

Approvals, registrations, permits and licences Schedule 1

Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. , 2012

Repeal the paragraphs, substitute:

(a) register a chemical product unless:

(i) the APVMA also approves each active constituent for

the product; and

(ii) the APVMA also approves a label for containers for the

product; or

(b) approve a label for containers for a chemical product unless it

also registers the product.

42 Subsection 16(1) of the Code set out in the Schedule

Omit "for a proposed or existing chemical product".

43 Sections 19 to 26 of the Code set out in the Schedule

Repeal the sections, substitute:

19 How approval of active constituent takes place

(1) Approval of an active constituent takes place when the APVMA

enters the following in the Record:

(a) the name of the person who applied for the approval as the

holder of the approval;

(b) the name of any nominated agent for the approval;

any instructions for the use of the constituent and any other

particulars prescribed by the regulations;

(d) any conditions of the approval imposed by the APVMA;

(e) the date the approval ends.

(2) The date the approval ends must:

(a) be worked out in accordance with the method prescribed by

the regulations; and

(b) be the last day of a calendar month at least 7 years but not

more than 15 years after the approval takes place.

(3) Despite subsection (2), the APVMA may approve the active

constituent for a period of less than 7 years to provide for its

approval to end at the same time as another approval of the active

constituent.

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32 Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. ,

2012

(4) Paragraph (2)(b) does not apply if the approval is subject to the

condition that it remains in force only for a stated period of not

more than 1 year (see subsection 23(2)).

20 How registration of chemical product takes place

(1) Registration of a chemical product takes place when the APVMA

enters the following in the Register:

(a) the name of the person who applied for the registration as the

holder of the registration;

(b) the name of any nominated agent for the registration;

any instructions for the use of the product and any other

particulars prescribed by the regulations;

(d) if the product is a listed chemical product--a notation to that

effect;

(e) any conditions of the registration imposed by the APVMA;

(f) the date the registration ends, which must be the last day of a

calendar month not more than 12 months after the

registration takes place;

(g) unless the product is a listed chemical product, and the

product and each label for the product comply with the

established standard for the product--the date (the last

renewal date) after which the registration cannot be renewed

under Division 6.

Rules about last renewal dates

(2) The last renewal date must:

(a) be worked out in accordance with the method prescribed by

the regulations; and

(b) if the last renewal date is entered in the Register when the

product is registered--be the last day of a calendar month at

least 7 years but not more than 15 years after the registration

takes place; and

relevant particulars or conditions of the registration are

varied--be the last day of a calendar month at least 7 years

but not more than 15 years after the variation takes place.

Approvals, registrations, permits and licences Schedule 1

Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. , 2012

Note:

For entering last renewal dates when relevant particulars or conditions

are varied, see sections 26D, 29B and 34A.

(3) However, the last renewal date may be less than 7 years after the

registration or variation takes place to provide for the last renewal

date to be the same as the last renewal date for another chemical

product that contains one or more of the same active constituents.

(4) Paragraphs (2)(b) and (c) do not apply if the registration is subject

to the condition that it remains in force only for a stated period of

not more than 1 year (see subsection 23(2)).

21 How approval of label takes place

Approval of a label takes place when the APVMA:

(a) determines the particulars prescribed by the regulations that

are appropriate to be contained on the label; and

(b) gives a distinguishing number to the label; and

file:

(i) the name of the person who applied for the approval as

the holder of the approval;

(ii) the name of any nominated agent for the approval;

(iii) the distinguishing number;

(iv) the instructions and any particulars that are to be

contained on the label;

(v) any conditions of the approval imposed by the APVMA.

22 Date of approval or registration

(1) The date of approval of an active constituent, of registration of a

chemical product or of approval of a label is the date on which the

relevant particulars are entered in the Record, Register or relevant

APVMA file.

(2)

If:

(a) any of the relevant particulars of:

(i) an approval of an active constituent; or

(ii) a registration of a chemical product; or

(iii) an approval of a label; or

Schedule 1 Approvals, registrations, permits and licences

34 Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. ,

2012

(b) any of the conditions of such an approval or registration

imposed by the APVMA;

are varied, then, the date of approval of the constituent, registration

of the product, or approval of the label, as varied, or as subject to

the varied conditions, is the date on which particulars of the

variation are entered in the Record, Register or relevant APVMA

file.

23 Conditions of approval or registration

(1) The approval of an active constituent, the registration of a chemical

product or the approval of a label for containers for a chemical

product is subject to:

(a) the conditions prescribed by the regulations (whether or not

the conditions are prescribed at the time the constituent,

product or label is approved or registered); and

(b) any conditions imposed on the approval or registration as the

APVMA thinks appropriate.

(2) An active constituent, chemical product or a label may be approved

or registered on the condition that the approval or registration

remains in force only for a stated period of not more than 1 year.

(3)

If:

(a) the approval or registration is subject to a condition referred

to in subsection (2); and

(b) the conditions of approval or registration have not been

varied before the end of the period referred to in the

condition, or the end of that period as previously extended

under this subsection, so as to remove the condition;

the APVMA may vary the condition so as to extend the period for

a further period of not more than 1 year.

26 Incorrect particulars and conditions

(1)

If:

(a) the APVMA is satisfied that a relevant particular or condition

entered in the Record or Register, or recorded in the relevant

APVMA file, is incorrect in a material respect; and

(b) the relevant particular or condition is of a kind prescribed by

the regulations;

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Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. , 2012

the APVMA must vary the entry or record accordingly.

Note:

For notice of variation, see section 8F.

(2) If the APVMA is satisfied that a relevant particular or condition

entered in the Record or Register, or recorded in the relevant

APVMA file, is incorrect in a material respect because of

inaccurate recording, the APVMA must vary the entry or record

accordingly.

Note:

For notice of variation, see section 8F.

(3) If the holder of the approval of an active constituent, the

registration of a chemical product or the approval of a label for

containers for a chemical product has reasonable cause to believe

that:

(a) a relevant particular or condition entered in the Record or

to the constituent, product or label is incorrect in a material

respect; and

(b) the relevant particular or condition is incorrect because of

inaccurate recording;

the holder must, within 28 days, give to the APVMA a written

notice, signed by the holder, identifying the incorrect particular or

condition and informing the APVMA of the correct particular or

condition.

(4) The holder commits an offence of strict liability if the holder

contravenes subsection (3).

Penalty: 30 penalty units.

Note:

For strict liability, see section 6.1 of the Criminal Code.

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

Note:

Division 2 of Part 9A provides for pecuniary penalties for

contraventions of civil penalty provisions.

44 Divisions 2A and 3 of Part 2 of the Code set out in the

Schedule

Repeal the Divisions, substitute:

Schedule 1 Approvals, registrations, permits and licences

36 Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. ,

2012

Division 2A--Varying prescribed relevant particulars

26A Explanation of Division

(1) This Division provides for the variation of a relevant particular of

an approval or registration if the relevant particular is set out in a

legislative instrument made under section 26B.

(2) Only the holder of the approval or registration may apply under

this Division (section 26B). The application must meet the

application requirements specified in section 8A.

(3) The APVMA must vary the relevant particular if specified criteria

are met, otherwise it must refuse the application (section 26C).

(4) Section 26D sets out how a variation takes place.

26B Applications

(1) The holder may apply to the APVMA for variation of a relevant

particular of an approval or registration if the relevant particular is

of a kind set out in a legislative instrument made by the APVMA

for the purposes of this section.

(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.

26C Varying prescribed relevant particulars

(1) The APVMA must vary the relevant particular if it is satisfied:

(a) that the application meets the application requirements; and

(b) for an active constituent--that, if the particular were varied

in accordance with the application, the constituent would

meet the safety criteria; and

accordance with the application, the product would:

(i) meet the safety criteria, the trade criteria and the

efficacy criteria; or

Approvals, registrations, permits and licences Schedule 1

Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. , 2012

(ii) comply with the established standard for the product;

and

(d) for a label for a chemical product--that, if the particular were

varied in accordance with the application, the label would:

(i) meet the labelling criteria; or

(ii) comply with the established standard for the product.

Note:

For notice of variation, see section 8F.

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

Note:

For notice of refusal, see section 8G.

26D How variation takes place

(1) Variation of a relevant particular under this Division takes place

when the APVMA records in the Record, Register or relevant

APVMA file, as required, the relevant particular as varied and the

date on which the variation is made.

(2)

If:

(a) the relevant particular is varied in such a way that a listed

chemical product or any approved label for the product does

not comply with the established standard for the product; and

(b) there is no date entered in the Register as the date after which

the registration of the product cannot be renewed under

Division 6;

the APVMA must enter such a date in the Register.

Note:

See section 20 for rules about the date after which a registration

cannot be renewed under Division 6.

(3)

If:

(a) the relevant particular is varied in such a way that a listed

chemical product and every approved label for the product

comply with the established standard for the product; and

(b) there is a date entered in the Register as the date after which

the registration of the product cannot be renewed under

Division 6;

the APVMA must remove the date from the Register.

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38 Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. ,

2012

Division 3--Varying relevant particulars and conditions

26E Explanation of Division

(1) This Division provides generally for variation of relevant

particulars or conditions of approvals and registrations.

(2) Holders and other persons may apply under this Division.

(3) Section 27 provides for applications to be made. An application

must meet the application requirements specified in section 8A.

(4) The APVMA must complete a preliminary assessment of the

application. If the application passes preliminary assessment, the

APVMA must notify the applicant and may be required to publish

a summary of the application (section 28).

(5) The APVMA must vary the relevant particulars or conditions if

specified criteria are met (section 29).

(6) The APVMA may vary relevant particulars or conditions on its

own initiative with the consent of the holder (section 29A).

(7) Section 29B sets out how a variation takes place.

27 Applications

(1) The holder may apply to the APVMA for variation of the relevant

particulars or conditions of:

(a) the approval of an active constituent; or

(b) the registration of a chemical product; or

Note:

The APVMA may only vary relevant particulars or conditions that it

has imposed. See section 6B.

(2) A person may, with the consent of the holder, apply to the

APVMA for variation of the relevant particulars or conditions of:

(a) the registration of a chemical product; or

(b) the approval of a label for containers for a chemical product.

(3) An application under subsection (1) or (2) must meet the

application requirements.

Note: For

meets the application requirements, see section 8A.

Approvals, registrations, permits and licences Schedule 1

Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. , 2012

(4) The fee (if any) for the application must be reduced (but not below

zero) by the amount of any fee paid for a previous application for

the variation made under Division 2A.

28 Preliminary assessment

(1) The APVMA must complete a preliminary assessment of the

application within 1 month after it is lodged.

(2) If it appears from the preliminary assessment that the application

meets the application requirements, the APVMA must, within 14

days:

(a) give written notice to the applicant:

(i) stating that the application has passed preliminary

assessment and that it will be determined under

section 29; and

(ii) setting out any matters prescribed by the regulations;

and

(b) if the variation relates to the use of a chemical product--

publish a summary of the application including any details

prescribed by the regulations.

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

Note:

For notice of refusal, see section 8G.

(4) The APVMA may alter the application, after it has passed

preliminary assessment, with the written consent of:

(a) the applicant; and

(b) if the applicant is not the holder--the holder.

29 Varying relevant particulars and conditions

(1) The APVMA must vary the relevant particulars or conditions if it

is satisfied:

(a) that the application meets the application requirements; and

(b) for an active constituent--that, if those particulars or

conditions were varied in accordance with the application,

the constituent would meet the safety criteria; and

conditions were varied in accordance with the application,

the product would:

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40 Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. ,

2012

(i) meet the safety criteria, the trade criteria and the

efficacy criteria; or

(ii) comply with the established standard for the product;

and

(d) for a label for a chemical product--that, if those particulars

or conditions were varied in accordance with the application,

the label would:

(i) meet the labelling criteria; or

(ii) comply with the established standard for the product.

Note:

For notice of variation, see section 8F.

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

Note:

For notice of refusal, see section 8G.

29A APVMA may vary on its own initiative with holder's consent

(1) The APVMA may, on its own initiative, and with the written

consent of the holder, vary the relevant particulars or conditions of

an approval or registration.

Note 1:

The APVMA may only vary relevant particulars or conditions that it

has imposed. See section 6B.

Note 2:

For notice of variation, see section 8F.

(2) The APVMA may vary the relevant particulars or conditions only

if it is satisfied:

(a) for an active constituent--that, if those particulars or

conditions were so varied, the constituent would meet the

safety criteria; and

(b) for a chemical product--that, if those particulars or

conditions were so varied, the product would:

(i) meet the safety criteria, the trade criteria and the

efficacy criteria; or

(ii) comply with the established standard for the product;

and

or conditions were so varied, the label would:

(i) meet the labelling criteria; or

(ii) comply with the established standard for the product.

(3) No fee is payable in relation to a variation made under this section.

Approvals, registrations, permits and licences Schedule 1

Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. , 2012

(4) Nothing in this Code requires the APVMA to make a variation

under this section.

29B How variation takes place

(1) Variation of relevant particulars or conditions under this Division

takes place when the APVMA records in the Record, Register or

relevant APVMA file, as required, the relevant particulars or

conditions as varied and the date on which the variation is made.

(2)

If:

(a) the relevant particulars or conditions are varied in such a way

that a listed chemical product or any approved label for the

product does not comply with the established standard for the

product; and

(b) there is no date entered in the Register as the date after which

the registration of the product cannot be renewed under

Division 6;

the APVMA must enter such a date in the Register.

Note:

See section 20 for rules about the date after which a registration

cannot be renewed under Division 6.

(3)

If:

(a) the relevant particulars or conditions are varied in such a way

that a listed chemical product and every approved label for

the product comply with the established standard for the

product; and

(b) there is a date entered in the Register as the date after which

the registration of the product cannot be renewed under

Division 6;

the APVMA must remove the date from the Register.

45 Division 4 of Part 2 of the Code set out in the Schedule

(heading)

Repeal the heading, substitute:

Division 4--Reconsidering approvals and registrations

46 Before section 30 of the Code set out in the Schedule

Insert:

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42 Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. ,

2012

29L Explanation of Division

(1) This Division provides for reconsideration of approvals and

registrations.

(2) The APVMA may invite proposals for reconsideration

(section 30), and the APVMA may reconsider an approval or

registration at any time (section 31).

(3) Before reconsidering an approval or registration, the APVMA must

prepare a work plan (section 31), notify the holder and invite the

holder to make a written submission on the reconsideration. The

holder will also be required to give the APVMA information

relevant to the reconsideration (section 32).

(4) The APVMA may inform any person that the APVMA proposes to

reconsider, or is reconsidering, the approval or registration and

invite written submissions (section 32).

(5) The APVMA may require the holder to conduct trials or

experiments or provide information or samples for the purposes of

the reconsideration (section 33).

(6) The APVMA must affirm the approval or registration if it is

satisfied that the constituent or product concerned meets specified

criteria (section 34).

(7) The APVMA must vary the relevant particulars or conditions of

the approval or registration if the APVMA is satisfied that they can

be varied in such a way as to allow the approval or registration to

be affirmed (section 34A).

(8) If the APVMA does not affirm the approval or registration, it must

suspend or cancel the approval or registration (section 34AA).

(9) The APVMA must give notice of what it proposes to do before it:

(a) varies the relevant particulars or conditions; or

(b) suspends or cancels the approval or registration

(section 34AB).

(10) If the APVMA affirms the approval or registration:

(a) it must notify the holder and publish a notice in the Gazette

(section 34AC); and

Approvals, registrations, permits and licences Schedule 1

Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. , 2012

(b) if the reconsideration was required by section 29H

(reconsideration if APVMA does not re-approve or

re-register)--it must re-approve or re-register the constituent

or product (section 34AD); and

(section 34AE).

(9) The APVMA may reconsider the approval of a label to determine

whether the instructions on the label are adequate (section 34AF).

47 Section 30 of the Code set out in the Schedule (heading)

Repeal the heading, substitute:

30 Inviting the public to propose reconsiderations

48 Subsection 30(1) of the Code set out in the Schedule

Omit "cause to be published", substitute "at any time publish".

49 Subsection 30(1) of the Code set out in the Schedule

Omit "for proposed or existing chemical products, or to propose

chemical products,", substitute ", chemical products or labels".

50 At the end of section 31 of the Code set out in the

Schedule

Add:

(2) Before commencing the reconsideration, the APVMA must prepare

a work plan in accordance with any requirements prescribed by the

regulations.

(3) The work plan:

(a) must be maintained in accordance with the regulations; and

(b) is not a legislative instrument.

51 Section 32 of the Code set out in the Schedule (heading)

Repeal the heading, substitute:

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44 Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. ,

2012

32 Notice of reconsideration

52 Subsections 32(1) to (3A) of the Code set out in the

Schedule

Repeal the subsections, substitute:

(1) The APVMA must give written notice to the holder:

(a) setting out the matters it proposes to deal with in the

reconsideration and its reasons for so proposing; and

(b) requiring the holder, within a period stated in the notice that

ends not earlier than 28 days after the day the notice is given,

to give to the APVMA either or both of the following:

(i) any information of a kind stated in the notice of which

the holder is aware and which is relevant to the

reconsideration;

(ii) any information of which the holder is aware that is

relevant to the reconsideration; and

submission to the APVMA about the matters referred to in

paragraph (a); and

(d) setting out the work plan.

(1A) The APVMA may, by written notice given to the holder, extend

the period stated in the notice.

(2) The APVMA may, if it thinks it desirable to do so, inform any

person, in any manner that it thinks appropriate, that the APVMA

proposes to reconsider, or is reconsidering, the approval or

registration.

(2A) If the APVMA informs a person as mentioned in subsection (2), it

must:

(a) inform the person of:

(i) the matters that it proposes to reconsider, or is

reconsidering; and

(ii) the work plan; and

(b) invite any person to make, within a specified period which

must not end earlier than 28 days after the invitation is given,

a written submission to the APVMA about the matters it

proposes to reconsider, or is reconsidering.

Approvals, registrations, permits and licences Schedule 1

Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. , 2012

(2B) Nothing in subsections (1), (2) or (2A):

(a) requires the APVMA to deal with a particular matter as part

of the reconsideration; or

(b) prevents the APVMA from dealing with a particular matter

as part of the reconsideration.

(3) The holder must comply with a requirement made of the holder

under paragraph (1)(b).

Note:

A person does not commit an offence by failing to do something the

person is not capable of doing. See subsections 4.2(1) and (4) of the

Criminal Code.

53 Subsection 32(4) of the Code set out in the Schedule

Omit "interested person or an approved person", substitute "holder".

54 Subsection 32(5) of the Code set out in the Schedule

Repeal the subsection, substitute:

(5) The holder commits an offence of strict liability if the holder

contravenes subsection (3).

Penalty: 120 penalty units.

Note 1:

For strict liability, see section 6.1 of the Criminal Code.

Note 2:

A defendant bears an evidential burden in relation to the matter in

subsection (4). See subsection 13.3(3) of the Criminal Code.

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

Note 1:

Division 2 of Part 9A provides for pecuniary penalties for

contraventions of civil penalty provisions.

Note 2:

For the evidential burden in civil penalty proceedings in relation to the

matter in subsection (4), see section 145CD.

55 Section 33 of the Code set out in the Schedule (heading)

Repeal the heading, substitute:

33 APVMA may require information, reports, results or samples

56 Subsections 33(1) to (2A) of the Code set out in the

Schedule

Repeal the subsections, substitute:

Schedule 1 Approvals, registrations, permits and licences

46 Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. ,

2012

(1) The APVMA may, by written notice given to the holder, require

the holder, within a reasonable period stated in the notice or such

further period as the APVMA allows, to do one or more of the

following for the purposes of the reconsideration:

(a) give to the APVMA information of a kind stated in the

notice;

(b) carry out a search of published literature for information and

give a report to the APVMA on the results of that search;

experiments and give the results of the trials or experiments

to the APVMA;

(d) give to the APVMA, or to another body specified in the

notice, a sample of an active constituent, or of a chemical

product or any of its constituents, for the purpose of analysis

by an approved analyst.

The information, trials, experiments or analysis must be relevant to

the reconsideration.

(1A) The period stated in the notice must be no longer than the period

prescribed by the regulations.

(1B) The APVMA may allow a further period only in the circumstances

prescribed by the regulations.

(1C) The power under subsection (1) includes the power to require the

holder to give to the APVMA information, a report, results or a

sample in addition to any information, report, results, or sample

previously given by the holder to the APVMA under any provision

of this Code other than this section.

(1D) Any information, report, results or sample that the holder has to

give to the APVMA or another body under subsection (1) must be

given as follows:

(a) information, a report or results must be given in writing:

(i) signed by the holder; or

(ii) attached to a covering letter signed by the holder;

(b) a sample must be:

(i) labelled with a label signed by the holder; or

(ii) attached to a covering letter signed by the holder.

Note:

For giving information electronically, see section 156A.

Approvals, registrations, permits and licences Schedule 1

Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. , 2012

(2) The holder must comply with a requirement made of the holder

under subsection (1).

Note:

A person does not commit an offence by failing to do something the

person is not capable of doing. See subsections 4.2(1) and (4) of the

Criminal Code.

57 Subsection 33(3) of the Code set out in the Schedule

Omit "interested person or an approved person", substitute "holder".

58 Subsection 33(4) of the Code set out in the Schedule

Repeal the subsection, substitute:

(4) The holder commits an offence of strict liability if the holder

contravenes subsection (2).

Penalty: 120 penalty units.

Note 1:

For strict liability, see section 6.1 of the Criminal Code.

Note 2:

A defendant bears an evidential burden in relation to the matter in

subsection (3). See subsection 13.3(3) of the Criminal Code.

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

Note 1:

Division 2 of Part 9A provides for pecuniary penalties for

contraventions of civil penalty provisions.

Note 2:

For the evidential burden in civil penalty proceedings in relation to the

matter in subsection (3), see section 145CD.

59 Sections 34 and 34A of the Code set out in the Schedule

Repeal the sections, substitute:

34 Reconsideration by APVMA

(1) The APVMA must affirm the approval or registration if, and only

if, it is satisfied:

(a) for an active constituent--that the constituent meets the

safety criteria; and

(b) for a chemical product--that the product meets the safety

criteria, the trade criteria and the efficacy criteria; and

(d) that the constituent, product or label complies with any

requirement prescribed by the regulations.

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48 Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. ,

2012

(2) Subsection (1) applies only to the extent that the APVMA decides

to reconsider matters covered by the subsection.

(3) For the purposes of subsection (1), the APVMA:

(a) must have regard to:

(i) any information given, or submissions made, to the

APVMA in response to a notice given under subsection

32(1); and

(ii) any submissions made to the APVMA in response to an

invitation under paragraph 32(2A)(b) or 34AB(2)(f);

and

(iii) any information given by the holder in response to an

invitation given by the APVMA (whether or not under

this Code) in relation to the constituent, product or

label; and

(iv) any information, report, results or sample given to the

APVMA in response to a notice given under section 33;

and

(v) any information given to the APVMA as required by

section 161 in relation to the constituent, product or

label; and

(vi) any other information that it considers necessary to

enable it to make a decision on the reconsideration; but

(b) must not take into account any submission, information,

report, results or sample not covered by paragraph (a).

34A Varying relevant particulars or conditions to allow affirmation

(1)

the

APVMA:

(a) is not satisfied as mentioned in subsection 34(1); but

(b) is satisfied that the relevant particulars or conditions of the

approval or registration can be varied in such a way as to

allow the approval or registration to be affirmed;

the APVMA must vary the relevant particulars or conditions.

Note:

The APVMA may only vary relevant particulars or conditions that it

has imposed. See section 6B.

(2) For the purposes of paragraph (1)(b), the APVMA may have

regard only to the following:

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Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. , 2012

(a) submissions, information, reports, results or samples that it

had regard to under section 34;

(b) submissions made to the APVMA in response to the

invitation under paragraph 34AB(2)(f).

(3) If the variation would affect any instructions for the use of an

active constituent or chemical product, or any instructions on a

label, the APVMA must not make the variation until it has

consulted each co-ordinator designated for a jurisdiction and taken

into account any recommendations made by the co-ordinators.

(4) If the APVMA varies the relevant particulars or conditions, it must

record in the Record, Register or relevant APVMA file, as

required, the relevant particulars or conditions as varied and the

date on which the variation is made.

(5)

If:

(a) the relevant particulars or conditions are varied in such a way

that a listed chemical product or any approved label for the

product does not comply with the established standard for the

product; and

(b) there is no date entered in the Register as the date after which

the registration of the product cannot be renewed under

Division 6;

the APVMA must enter such a date in the Register.

Note:

See section 20 for rules about the date after which a registration

cannot be renewed under Division 6.

(6)

If:

(a) the relevant particulars or conditions are varied in such a way

that a listed chemical product and every approved label for

the product comply with the established standard for the

product; and

(b) there is a date entered in the Register as the date after which

the registration of the product cannot be renewed under

Division 6;

the APVMA must remove the date from the Register.

34AA Suspension or cancellation

(1) If the APVMA does not affirm the approval or registration, it must

suspend or cancel the approval or registration.

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50 Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. ,

2012

(2) If the reconsideration is of the approval of a label for containers for

a chemical product, the APVMA must suspend or cancel the

approval if:

(a) the APVMA is satisfied that the relevant particulars of the

approval can be varied in such a way as to allow the approval

to be affirmed; but

(b) the holder does not satisfy the APVMA that a label, including

the particulars as varied, will be attached to the containers for

the product.

(3) Subsection (2) has effect despite subsection 34A(1).

Note:

For general requirements in relation to suspension and cancellation,

see Division 5.

34AB Notice of proposed decision

(1) The APVMA must give notice of what it proposes to do before it:

(a) varies the relevant particulars or conditions under

section 34A; or

(b) suspends or cancels the approval or registration under

section 34AA.

(2) The notice must:

(a) be given to the holder in writing; and

(b) be given to the other persons informed of the reconsideration

as mentioned in subsection 32(2):

(i) in writing; or

(ii) in the way the persons were informed under that

subsection; and

of action; and

(d) set out the information on which the reasons are based

(including information not given to the APVMA by the

holder); and

(e) for variation of relevant particulars or conditions--set out the

proposed variation; and

(f) invite written submissions from the holder or other persons

within 3 months.

(3) The APVMA is not required to comply with this section more than

once in relation to:

Approvals, registrations, permits and licences Schedule 1

Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. , 2012

(a) variation of the relevant particulars or conditions; or

(b) suspension or cancellation of the approval or registration.

34AC Notice of decision on reconsideration

(1) If the APVMA affirms the approval or registration, the APVMA

must, within 14 days:

(a) give written notice of the affirmation to the holder; and

(b) publish a notice of the affirmation in the Gazette and in any

other manner that it thinks appropriate.

(2) The notice given to the holder must:

(a) state that the approval or registration has been affirmed; and

(b) set out the relevant particulars and conditions of the approval

or registration as affirmed; and

(d) for registration--state the date (if any) after which the

registration cannot be renewed under Division 6; and

(e) include any information prescribed by the regulations.

(3) The notice in the Gazette must:

(a) state that the approval or registration has been affirmed; and

(b) contain a brief statement of the reasons for the affirmation.

Note:

If the APVMA does not affirm the approval or registration, it must

suspend or cancel the approval or registration under section 34AA.

For notice of suspension or cancellation, see Division 5.

34AD Affirmation leading to re-approval or re-registration

If:

(a) the APVMA affirms the approval or registration; and

(b) the reconsideration was required by section 29H

(reconsideration if APVMA does not re-approve or

re-register);

the APVMA must, as soon as practicable, re-approve or re-register

the constituent or product.

34AE Varying duration of approval or registration

(1) If the APVMA affirms the approval or registration, it may vary:

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52 Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. ,

2012

(a) the date (the end date) the approval ends, which, if varied,

must be the last day of a calendar month at least 7 years but

not more than 15 years after the approval is affirmed; or

(b) either or both of the following:

(i) the date the registration ends, which must be the last day

of a calendar month;

(ii) if, before the reconsideration began, there was a date

entered in the Register as the date after which the

registration cannot be renewed under Division 6--that

date (the last renewal date).

(2) If varied, the end date or last renewal date must:

(a) be worked out in accordance with the method prescribed by

the regulations; and

(b) be the last day of a calendar month at least 7 years but not

more than 15 years after the approval or registration is

affirmed.

(3) However, the end date or renewal date, as varied, may be less than

7 years after the approval or registration is affirmed to provide for

the date to be the same as:

(a) for an approval--the end date for another approval of the

active constituent; or

(b) for a registration--the last renewal date for another chemical

product that contains one or more of the same active

constituents.

(4) Paragraph (2)(b) does not apply if the approval or registration is

subject to the condition that it remains in force only for a stated

period of not more than 1 year (see subsection 23(2)).

(5) Nothing in this Code requires the APVMA to make a variation

under this section.

(6) This section does not apply in relation to a reconsideration required

by section 29H (reconsideration if APVMA does not re-approve or

re-register).

Approvals, registrations, permits and licences Schedule 1

Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. , 2012

34AF Reconsideration of approval of label without notice in certain

circumstances

(1) The APVMA may, at any time, reconsider the approval of a label

for the purpose of deciding whether the label contains adequate

instructions relating to matters prescribed by the regulations for the

purposes of this section.

(2) The matters that may be prescribed must be matters covered by the

definition of meets the labelling criteria.

(3) If the APVMA considers that the particulars do not contain

adequate instructions in relation to a matter, the APVMA must:

(a) vary the relevant particulars; and

(b) record in the relevant APVMA file the relevant particulars as

varied and the date on which the record is made; and

variation.

(4) Sections 30 to 34AE do not apply to a reconsideration under this

section.

60 Section 40 of the Code set out in the Schedule

Repeal the section.

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

After "sections", insert "29D,".

62 Division 7 of Part 2 of the Code set out in the Schedule

Repeal the Division.

63 Part 2A of the Code set out in the Schedule

Repeal the Part.

64 Subsection 56ZU(3) of the Code set out in the Schedule

Omit "having custody of, use of, or other dealing with, each", substitute

"custody or use of each".

65 Paragraph 56ZU(4)(c) of the Code set out in the Schedule

Repeal the paragraph, substitute:

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54 Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. ,

2012

explanation as to why the APVMA is satisfied that the

product, or class of products, meets the safety criteria, the

trade criteria and the efficacy criteria; and

66 Paragraphs 72(2)(a), (b) and (c) of the Code set out in the

Schedule

Repeal the paragraphs, substitute:

(a) the supply of unapproved active constituents for chemical

products and unregistered chemical products; and

(b) their possession for the purposes of supply; and

have been approved and the supply of chemical products that

have been registered or reserved in contravention of the

conditions of their approval, registration or reservation.

67 Subsection 72(4) of the Code set out in the Schedule

Omit "or", substitute "for chemical products and".

68 Subsection 74(5) of the Code set out in the Schedule

Repeal the subsection.

69 Section 75 of the Code set out in the Schedule (heading)

Repeal the heading, substitute:

75 Possession or custody of chemical products, other than registered

or reserved products, with the intention of supply

70 Subsection 75(1) of the Code set out in the Schedule

Omit ", a registered listed chemical product".

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

Omit ", a registered listed chemical product".

72 Subsection 75(5) of the Code set out in the Schedule

Repeal the subsection.

73 Subsection 76(5) of the Code set out in the Schedule

Approvals, registrations, permits and licences Schedule 1

Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. , 2012

Repeal the subsection.

74 Section 78 of the Code set out in the Schedule (heading)

Repeal the heading, substitute:

78 Supply of chemical products that are not registered products or

reserved products

75 Subsection 78(1) of the Code set out in the Schedule

Omit ", a registered listed chemical product".

76 Subparagraph 78(1)(c)(i) of the Code set out in the

Schedule

Omit ", granted listed registration, or reserved,", substitute "or

reserved".

77 Subparagraph 78(1)(c)(ii) of the Code set out in the

Schedule

Omit ", granted listed registration,".

78 Subparagraph 78(1)(c)(iii) of the Code set out in the

Schedule

Omit ", granted listed registration,".

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

Omit ", a registered listed chemical product".

80 Subsection 78(5) of the Code set out in the Schedule

Repeal the subsection.

81 Paragraph 83(1)(a) of the Code set out in the Schedule

Omit "of Chemical Products".

82 Section 83A of the Code set out in the Schedule

Repeal the section.

83 Paragraph 84(1)(a) of the Code set out in the Schedule

Omit "or registered listed chemical product".

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56 Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. ,

2012

84 Paragraph 84(1)(b) of the Code set out in the Schedule

Omit "or registered listed chemical product".

85 Subsection 84(1) of the Code set out in the Schedule

Omit "listed" (last 2 occurring).

86 Subsection 87(1) of the Code set out in the Schedule

Repeal the subsection, substitute:

(1) This section applies to a chemical product if:

(a) a standard is prescribed in respect of the product or in respect

of a constituent contained in the product; and

(b) the product is:

(i) a listed chemical product; or

(ii) prescribed for the purposes of this section.

87 Paragraph 88(2)(b) of the Code set out in the Schedule

Omit "neither a registered chemical product nor a registered listed",

substitute "not a registered".

88 Paragraph 88(2)(c) of the Code set out in the Schedule

Omit "or listed registration".

89 Subparagraph 88(2)(d)(i) of the Code set out in the

Schedule

Omit "neither a registered chemical product nor a registered listed",

substitute "not a registered".

90 Paragraph 88(3)(b) of the Code set out in the Schedule

Omit "neither a registered chemical product nor a registered listed",

substitute "not a registered".

91 Section 89A of the Code set out in the Schedule

Omit "listable", substitute "listed".

92 Paragraph 97(4)(b) of the Code set out in the Schedule

Omit "or listed registration".

93 Section 99 of the Code set out in the Schedule (heading)

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Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. , 2012

Repeal the heading, substitute:

99 Analysis of chemical products and active constituents

94 Subsection 99(1) of the Code set out in the Schedule

Omit "If", substitute "This section applies if".

95 Subsection 99(1) of the Code set out in the Schedule

Omit ", the following provisions apply".

96 Subsection 99(2) of the Code set out in the Schedule

Omit ", or has been granted listed registration under Division 4 of

Part 2A,".

97 Paragraphs 99(2)(a), (b) and (c) of the Code set out in the

Schedule

Omit "of Chemical Products".

98 Subsection 99(6) of the Code set out in the Schedule

Omit "cause to be published", substitute "publish".

99 Subparagraph 99(6)(a)(ii) of the Code set out in the

Schedule

Omit "interested person in relation to the product--the interested

person", substitute "holder of the registration--the holder".

100 Subsection 99(8) of the Code set out in the Schedule

Repeal the subsection.

101 Section 101 of the Code set out in the Schedule

(heading)

Repeal the heading, substitute:

101 Recall of products that are not registered or whose registration

is being reconsidered

102 Paragraph 101(1)(a) of the Code set out in the Schedule

Omit ", and has not been granted listed registration,".

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58 Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. ,

2012

103 Paragraph 101(1)(b) of the Code set out in the Schedule

Repeal the paragraph, substitute:

(b) the APVMA is reconsidering the registration of a chemical

product under Division 4 of Part 2 of that Code;

104 Paragraph 101(2)(c) of the Code set out in the Schedule

Omit "and has not been granted listed registration".

105 Subsection 101(3) of the Code set out in the Schedule

Repeal the subsection.

106 Paragraphs 102(1)(a) and (aa) of the Code set out in the

Schedule

Repeal the paragraphs, substitute:

(a) a chemical product may not meet the safety criteria, the trade

criteria or the efficacy criteria; or

107 Paragraph 102(1)(b) of the Code set out in the Schedule

Omit "of Chemical Products".

108 Paragraph 102(1)(ba) of the Code set out in the Schedule

Repeal the paragraph.

109 Paragraph 102(1)(c) of the Code set out in the Schedule

Omit "of Chemical Products".

110 Paragraph 102(1)(ca) of the Code set out in the Schedule

Repeal the paragraph.

111 Paragraph 102(1)(d) of the Code set out in the Schedule

Omit "of Chemical Products".

112 Paragraph 102(1)(e) of the Code set out in the Schedule

Repeal the paragraph.

113 Subsection 102(3) of the Code set out in the Schedule

Repeal the subsection.

Approvals, registrations, permits and licences Schedule 1

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114 Subsection 103(1) of the Code set out in the Schedule

Repeal the subsection, substitute:

(1) If it appears to the APVMA that labels attached to the containers:

(a) of stocks of a registered chemical product; or

(b) of a particular batch of a registered chemical product;

differ from the approved label for the product or the label required

by the established standard for the product, the APVMA may give

written notice to any person (the notified person) who has, or has

had, possession or custody of any of those stocks or of that batch in

this jurisdiction requiring the person to do any one or more of the

things mentioned in subsection (2).

115 Subsection 103(3) of the Code set out in the Schedule

Repeal the subsection.

116 Subsection 104(1) of the Code set out in the Schedule

Repeal the subsection, substitute:

(1) If the APVMA issues a recall notice, it must, within 14 days,

publish notice of the issue of the recall notice in the Gazette and in

any other manner that it thinks appropriate.

117 Paragraph 108(2)(a) of the Code set out in the Schedule

Omit ", a registered listed chemical product".

118 Paragraph 108(2)(a) of the Code set out in the Schedule

Omit ", registration or listed", substitute "or".

119 Paragraph 108(2)(b) of the Code set out in the Schedule

Omit "product; or", substitute "product.".

120 Paragraph 108(2)(c) of the Code set out in the Schedule

Repeal the paragraph.

121 Section 110 of the Code set out in the Schedule

(heading)

Repeal the heading, substitute:

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60 Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. ,

2012

110 Applications

122 Subsections 110(2) to (4) of the Code set out in the

Schedule

Repeal the subsections, substitute:

(2) The application must meet the application requirements.

Note: For

meets the application requirements, see section 8A.

123 After section 110 of the Code set out in the Schedule

Insert:

110A Preliminary assessment

(1) The APVMA must complete a preliminary assessment of the

application within 1 month after it is lodged.

(2) If it appears from the preliminary assessment that the application

meets the application requirements, the APVMA must, within 14

days, give written notice to the applicant:

(a) stating that the application has passed preliminary assessment

and that it will be determined under section 112; and

(b) setting out any matters prescribed by the regulations.

(3) If it appears from the preliminary assessment 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

(4) 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.

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(5) The APVMA may alter the application, after it has passed

preliminary assessment, with the written consent of the applicant.

124 Paragraph 111(1)(c) of the Code set out in the Schedule

Omit "application should be granted", substitute "permit should be

issued".

125 Section 112 of the Code set out in the Schedule

(heading)

Repeal the heading, substitute:

112 Issuing permits

126 Subsections 112(2) to (5) of the Code set out in the

Schedule

Repeal the subsections, substitute:

(2) The APVMA must issue the permit if it is satisfied:

(a) that the application meets the application requirements; and

(b) that the applicant has complied with any requirement made

by the APVMA under subparagraph 111(1)(b)(iii); and

safety criteria; and

(d) for a chemical product--that the product would meet the

safety criteria, the trade criteria and the efficacy criteria; and

(e) that any requirements prescribed by the regulations in

relation to the issue of a permit under this section have been

complied with; and

(f) if an application has not been made for approval of the

constituent or registration of the product or such an

application has not been determined--that there are

reasonable grounds for the application not having been made

or for issuing the permit pending determination of the

application; and

(g) if the application is for a permit to do, or omit to do, any

thing which would, apart from the permit, be an offence

against subsection 121(4A) or (5A) or a contravention of the

civil penalty provision set out in subsection 121(4) or (5)--

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62 Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. ,

2012

that there are exceptional circumstances that justify issuing

the permit.

Note:

For how permits are issued, see section 114.

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

Note:

For notice of refusal, see section 8G.

(4) Despite subsection (2), the APVMA must also refuse the

application if it is satisfied that:

(a) the applicant will be unable to comply with the conditions of

the permit; or

(b) at least one of the following persons:

(i)

the

applicant;

(ii) any other person who makes, or participates in making,

decisions that affect the whole, or a substantial part, of

the applicant's affairs;

(iii) if the applicant is a body corporate--a major interest

holder of the body corporate;

has, within the 10 years immediately before the application:

(iv) been convicted of an offence against an agvet law; or

(v) been convicted of an offence against a law of this or

another jurisdiction relating to chemical products; or

(vi) been convicted of an offence against a law of the

Commonwealth or a law of a State or Territory

involving fraud or dishonesty; or

(vii) been ordered to pay a pecuniary penalty for the

contravention of an agvet penalty provision; or

(viii) been ordered to pay a pecuniary penalty for the

contravention of another law of this or another

jurisdiction relating to chemical products; or

(ix) been ordered to pay a pecuniary penalty for the

contravention of a civil penalty provision of a law of the

Commonwealth or a law of a State or Territory

involving fraud or dishonesty; or

(x) held a permit that was cancelled under subsection

119(2) or section 119B of this Code or under a

corresponding provision of the Agvet Code of another

jurisdiction; or

Approvals, registrations, permits and licences Schedule 1

Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. , 2012

(xi) been a manager, or a major interest holder, of a body

corporate in respect of which subparagraph (iv), (v),

(vi), (vii), (viii), (ix) or (x) applies in that 10 year

period, if the conduct resulting in that subparagraph

applying occurred when the person was a manager or

major interest holder of the body corporate.

(5) A reference in paragraph (4)(b) to a person convicted of an offence

includes a reference to a person in respect of whom an order has

been made relating to the offence under:

(a) section 19B of the Crimes Act 1914; or

(b) a corresponding provision of a law of a State or Territory.

Note:

Section 19B of the Crimes Act 1914 empowers a court that has found

a person to have committed an offence to take action without

proceeding to record a conviction.

(6) However, the APVMA may issue the permit despite subsection (4)

if, in the opinion of the APVMA, special circumstances make it

appropriate to do so.

(7) If the APVMA refuses the application, it must give written notice

of the refusal to each co-ordinator to whom a copy of the

application was given.

127 After section 112 of the Code set out in the Schedule

Insert:

112A APVMA may issue permit on its own initiative

(1) The APVMA may, on its own initiative and in accordance with this

section, issue a permit to a person in respect of an active

constituent for a proposed or existing chemical product or in

respect of a chemical product.

(2) The APVMA may issue the permit if it is satisfied of the

following:

(a) that the active constituent or chemical product in respect of

which the permit is to be issued meets the safety criteria, the

trade criteria and the efficacy criteria;

(b) that any requirements prescribed by the regulations in

relation to the issue of a permit under this section have been

complied with;

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64 Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. ,

2012

constituent or registration of the product or such an

application has not been determined--that there are

reasonable grounds for the application not having been made

or for issuing the permit pending determination of the

application, as the case may be;

(d) if the permit would authorise a person to do, or omit to do,

any thing which would, apart from the permit, be an offence

against subsection 121(4A) or (5A) or a contravention of the

civil penalty provision set out in subsection 121(4) or (5)--

that there are exceptional circumstances that justify issuing

the permit.

Note:

For how permits are issued, see section 114.

(3) However, the APVMA must not issue the permit to a person (the

proposed permit holder) if it is satisfied that:

(a) the proposed permit holder will be unable to comply with the

conditions of the permit; or

(b) at least one of the following persons:

(i) the proposed permit holder;

(ii) any other person who makes, or participates in making,

decisions that affect the whole, or a substantial part, of

the proposed permit holder's affairs;

(iii) if the proposed permit holder is a body corporate--a

major interest holder of the body corporate;

has, within the previous 10 years:

(iv) been convicted of an offence against an agvet law; or

(v) been convicted of an offence against a law of this or

another jurisdiction relating to chemical products; or

(vi) been convicted of an offence against a law of the

Commonwealth or a law of a State or Territory

involving fraud or dishonesty; or

(vii) been ordered to pay a pecuniary penalty for the

contravention of an agvet penalty provision; or

(viii) been ordered to pay a pecuniary penalty for the

contravention of another law of this or another

jurisdiction relating to chemical products; or

(ix) been ordered to pay a pecuniary penalty for the

contravention of a civil penalty provision of a law of the

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Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. , 2012

Commonwealth or a law of a State or Territory

involving fraud or dishonesty; or

(x) held a permit that was cancelled under subsection

119(2) or section 119B of this Code or under a

corresponding provision of the Agvet Code of another

jurisdiction; or

(xi) been a manager, or a major interest holder, of a body

corporate in respect of which subparagraph (iv), (v),

(vi), (vii), (viii), (ix) or (x) applies, if the conduct

resulting in that subparagraph applying occurred when

the person was a manager or major interest holder of the

body corporate.

(4) A reference in paragraph (3)(b) to a person convicted of an offence

includes a reference to a person in respect of whom an order has

been made relating to the offence under:

(a) section 19B of the Crimes Act 1914; or

(b) a corresponding provision of a law of a State or Territory.

Note:

Section 19B of the Crimes Act 1914 empowers a court that has found

a person to have committed an offence to take action without

proceeding to record a conviction.

(5) However, the APVMA may issue the permit despite subsection (3)

if, in the opinion of the APVMA, special circumstances make it

appropriate to do so.

(6) If the active constituent or chemical product in respect of which the

permit is to be issued is approved or registered, the APVMA:

(a) must, before issuing the permit, give written notice of its

intention to do so to the holder of the approval or registration;

and

(b) must not issue the permit before the end of 28 days after the

day on which the notice is given.

(7) However, subsection (6) does not apply to the extent that, in the

opinion of the APVMA, special circumstances make it appropriate

to:

(a) issue the permit without giving written notice to the holder of

the approval or registration; or

(b) issue the permit before the end of the 28 days.

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66 Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. ,

2012

128 Section 114 of the Code set out in the Schedule

(heading)

Repeal the heading, substitute:

114 How permits are issued

129 Subsections 114(1) and (1A) of the Code set out in the

Schedule

Repeal the subsections.

130 Subsection 114(5) of the Code set out in the Schedule

Omit "As soon as practicable", substitute "Within 14 days".

131 Subsection 115(3) of the Code set out in the Schedule

Omit all the words after "extensions of the permit".

132 After subsection 115(3) of the Code set out in the

Schedule

Insert:

(3A) The APVMA may extend the permit for a further period that it

thinks appropriate if it is satisfied that:

(a) the application meets the application requirements; and

(b) any requirements prescribed by the regulations have been

met.

(3B) If the APVMA does not extend the permit, it must refuse the

application.

Note:

For notice of refusal, see section 8G.

133 At the end of subsection 115(5) of the Code set out in the

Schedule

Add:

Note:

For notice of refusal, see section 8G.

134 Subsection 115(6) of the Code set out in the Schedule

Repeal the subsection.

135 Subsection 117(1) of the Code set out in the Schedule

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Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. , 2012

Omit "an approved person", substitute "the holder".

136 Subsection 117(3) of the Code set out in the Schedule

Omit "as soon as practicable", substitute "within 14 days".

137 Subsection 118(8) of the Code set out in the Schedule

Repeal the subsection.

138 Subsection 118(10) of the Code set out in the Schedule

Omit "as soon as practicable", substitute "within 14 days".

139 Subsection 119(8) of the Code set out in the Schedule

Repeal the subsection.

140 Subsection 119(11) of the Schedule

Omit "as soon as practicable", substitute "within 14 days".

141 Section 120A of the Code set out in the Schedule

Omit "listable", substitute "listed".

142 Paragraphs 122(1)(a) to (e) of the Code set out in the

Schedule

Repeal the paragraphs, substitute:

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

(b) be signed by the applicant; and

required to be paid when the application is made; and

(d) be lodged with the APVMA; and

(e) contain, or be accompanied by, any information specified for

the application under section 8B.

143 Subsection 122(2) of the Code set out in the Schedule

Omit "in relation to an application for a licence, by written notice given

to an approved person", substitute "by written notice given to the

applicant".

144 Subsection 123(1) of the Code set out in the Schedule

Repeal the subsection, substitute:

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68 Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. ,

2012

(1) If an application is made for a licence to carry out steps in the

manufacture of chemical products (other than prohibited chemical

products) at particular premises, the APVMA must issue the

licence to the applicant unless the APVMA is satisfied that:

(a) the applicant has not complied with subsection 122(1) or any

requirement under subsection 122(2); or

(b) any requirement prescribed by the regulations in relation to

the application or the issue of the licence has not been

complied with; or

the licence; or

(d) the applicant will be unable to comply with the

manufacturing principles; or

(e) at least one of the following persons:

(i)

the

applicant;

(ii) any other person who makes, or participates in making,

decisions that affect the whole, or a substantial part, of

the applicant's affairs;

(iii) if the applicant is a body corporate--a major interest

holder of the body corporate;

has, within the 10 years immediately before the application:

(iv) been convicted of an offence against an agvet law; or

(v) been convicted of an offence against a law of this or

another jurisdiction relating to chemical products; or

(vi) been convicted of an offence against a law of the

Commonwealth or a law of a State or Territory

involving fraud or dishonesty; or

(vii) been ordered to pay a pecuniary penalty for the

contravention of an agvet penalty provision; or

(viii) been ordered to pay a pecuniary penalty for the

contravention of another law of this or another

jurisdiction relating to chemical products; or

(ix) been ordered to pay a pecuniary penalty for the

contravention of a civil penalty provision of a law of the

Commonwealth or a law of a State or Territory

involving fraud or dishonesty; or

(x) contravened a condition of a manufacturing licence

issued under an agvet law; or

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Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. , 2012

(xi) held a manufacturing licence or permit that was

cancelled under an agvet law, other than paragraph

127(1)(d) or (e) of this Code or a corresponding

provision of the Agvet Code of another jurisdiction; or

(xii) been a manager, or a major interest holder, of a body

corporate in respect of which subparagraph (iv), (v),

(vi), (vii), (viii), (ix), (x) or (xi) applies in that 10 year

period, if the conduct resulting in that subparagraph

applying occurred when the person was a manager or

major interest holder of the body corporate; or

(f) at least one of the following persons:

(i)

the

applicant;

(ii) any other person who makes, or participates in making,

decisions that affect the whole, or a substantial part, of

the applicant's affairs;

(iii) if the applicant is a body corporate--a major interest

holder of the body corporate;

has, within the 5 years immediately before the application,

failed to comply with a manufacturing principle in

connection with the manufacture of chemical products.

(1A) If the APVMA does not issue the licence, it must refuse the

application.

Note:

For notice of refusal, see section 8G.

(1B) A reference in paragraph (1)(e) to a person convicted of an offence

includes a reference to a person in respect of whom an order has

been made relating to the offence under:

(a) section 19B of the Crimes Act 1914; or

(b) a corresponding provision of a law of a State or Territory.

Note:

Section 19B of the Crimes Act 1914 empowers a court that has found

a person to have committed an offence to take action without

proceeding to record a conviction.

(1C) Paragraph (1)(f) does not apply to the extent that the APVMA

thinks the failure to comply with the manufacturing principle is not

relevant.

145 Subsection 123(2) of the Code set out in the Schedule

Omit "(b) or (c)", substitute "(e) or (f)".

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70 Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. ,

2012

146 Subsection 123(5) of the Code set out in the Schedule

Omit "cause", substitute "publish".

147 Subsection 123(5) of the Code set out in the Schedule

Omit "to be published".

148 Section 124 of the Code set out in the Schedule

Repeal the section.

149 Paragraphs 126(3)(a) and (b) of the Code set out in the

Schedule

Repeal the paragraphs, substitute:

(a) on the day on which the notice is given to the holder, but

only if the notice states that the action is necessary to prevent

one or more of the following:

(i) an imminent risk to persons of death, serious injury or

serious illness;

(ii) an imminent risk of unintended harm to animals, plants

or things, or to the environment;

(iii) an imminent risk of impact on trade or commerce

between Australia and places outside Australia; or

(b) otherwise--on a day stated for the purpose in the notice that,

unless the APVMA and the holder agree, is not earlier than

28 days after the notice is given to the holder.

150 Subsection 126(5) of the Code set out in the Schedule

Repeal the subsection.

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

Omit "in relation to a licence, by written notice given to an approved

person", substitute "by written notice given to the holder of a licence".

152 Paragraph 127(2)(a) of the Code set out in the Schedule

Omit "an approved person", substitute "the holder".

153 Subsection 127(6) of the Code set out in the Schedule

Repeal the subsection.

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Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. , 2012

154 Paragraph 149(3)(b) of the Code set out in the Schedule

Omit ", a registered chemical product or a registered listed", substitute

"or a registered".

155 Paragraph 152(2)(a) of the Code set out in the Schedule

Omit "a person", substitute "the holder of an approval or registration".

156 Paragraph 152(2)(a) of the Code set out in the Schedule

Omit all the words after "jurisdiction", substitute "in relation to an

active constituent or chemical product covered by the approval or

registration; and".

157 Paragraph 152(2)(b) of the Code set out in the Schedule

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

158 Subsection 152(2) of the Code set out in the Schedule

Omit "approved person who signed the application for the approval of

the constituent or the registration or listed registration, or the renewal of

the registration or listed registration, of the product", substitute

"nominated agent for the approval or registration".

159 Subsection 152(2) of the Code set out in the Schedule

Omit "first-mentioned person", substitute "holder".

160 Subsection 152(2) of the Code set out in the Schedule

Omit "approved person" (second occurring), substitute "nominated

agent".

161 After section 156 of the Code set out in the Schedule

Insert:

156A Giving information electronically

(1) If, under this Code, a person is required or permitted to give the

APVMA information (including an application) in writing, that

requirement is taken to have been met if:

(a) the APVMA consents to the information being given

electronically; and

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72 Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. ,

2012

(b) the person gives the information electronically in accordance

with any requirements mentioned in subsection (3); and

applicant or holder--the information includes the electronic

signature of the applicant or holder.

(2) If, under this Code, a person is required or permitted to give the

APVMA information in writing, the regulations may, despite any

other provision of this Code, require that the information be given

only electronically and in accordance with any requirements

mentioned in subsection (3).

(3) For the purposes of subsections (1) and (2), the APVMA may

require that the information be given, in accordance with particular

information technology requirements, by means of a particular

kind of electronic communication.

(4) If, under this Code, the APVMA is required or permitted to give a

person information in writing, that requirement is taken to have

been met if:

(a) the person consents to the information being given

electronically; and

(b) the APVMA gives the information electronically; and

Executive Officer's electronic signature; and

(d) in a case where a person's failure to do, or not do, a thing set

out in the information is an offence against this Code or the

contravention of a civil penalty provision--the APVMA has

adequate systems for proving the person received the

information.

(5) This section applies to a requirement or permission to give

information, whether the expression "give", "lodge", "send" or

"serve", or any other expression, is used.

(6) For the purposes of this section, giving information includes, but is

not limited to, the following:

(a) making or withdrawing an application;

(b) making or lodging a claim;

(d) giving a report;

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Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. , 2012

(e) making a request;

(f) making a declaration;

(g) lodging or issuing a certificate;

(h) giving a statement of reasons.

162 Subsection 157(1) of the Code set out in the Schedule

Omit "If the APVMA so requires, a person who makes an application

under this Code must", substitute "For the purposes of determining an

application under this Code, the APVMA may require the applicant to".

163 Paragraphs 159(1)(a) and (b) of the Code set out in the

Schedule

Before "an application", insert "determining".

164 Paragraph 159(1)(c) of the Code set out in the Schedule

Repeal the paragraph.

165 Subparagraph 159(1)(d)(iv) of the Code set out in the

Schedule

Repeal the subparagraph.

166 Subsection 159(1) of the Code set out in the Schedule

Omit "interested person or an approved person, require the interested

person, or the applicant for or holder of the relevant permit", substitute

"applicant (for the purposes of paragraph (a) or (b)) or the holder (for

the purposes of paragraph (d)), require the applicant or holder".

167 Paragraph 159(1)(e) of the Code set out in the Schedule

Omit ", that may be relevant to the application, reconsideration or

decision".

168 After subsection 159(1) of the Code set out in the

Schedule

Insert:

(1AA) The period stated in the notice must be no longer than the period

prescribed by the regulations.

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74 Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. ,

2012

(1AB) The APVMA may allow a further period only in the circumstances

prescribed by the regulations.

169 Subsection 159(2) of the Code set out in the Schedule

Omit "a person", substitute "an applicant or holder".

170 Subsection 159(2) of the Code set out in the Schedule

Omit "an approved person", substitute "the applicant or holder".

171 At the end of subsection 159(2) of the Code set out in the

Schedule

Add:

Note:

For giving information electronically, see section 156A.

172 Subsection 159(3) of the Code set out in the Schedule

Omit all the words after "APVMA", substitute "must refuse the

application".

173 At the end of subsection 159(3) of the Code set out in the

Schedule

Add:

Note:

For notice of refusal, see section 8G.

174 Subsections 159(4) and (5) of the Code set out in the

Schedule

Repeal the subsections.

175 Section 160 of the Code set out in the Schedule

(heading)

Repeal the heading, substitute:

160 Overseas trials and experiments etc.

176 Section 160 of the Code set out in the Schedule

Omit "For", substitute "(1) This section applies for".

177 Paragraph 160(a) of the Code set out in the Schedule

Before "an application", insert "determining".

Approvals, registrations, permits and licences Schedule 1

Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. , 2012

178 Paragraph 160(b) of the Code set out in the Schedule

Before "an application" (first occurring), insert "determining".

179 Paragraph 160(c) of the Code set out in the Schedule

Omit "registration or listed".

180 Paragraph 160(d) of the Code set out in the Schedule

Omit "product;", substitute "product.".

181 Section 160 of the Code set out in the Schedule

Omit all the words from and including "the APVMA".

182 At the end of section 160 of the Code set out in the

Schedule

Add:

(2) The APVMA may take account of any of the following:

(a) the results of any trials or experiments already carried out in

a foreign country in relation to an active constituent for a

proposed or existing chemical product, or in relation to a

chemical product or any of its constituents;

(b) any decisions or evaluations made by regulators of

agricultural or veterinary chemicals in a foreign country;

in paragraph (b) is based;

to the extent that those results, decisions or evaluations are, or that

information is, relevant having regard to any matters the APVMA

thinks appropriate, including any of the matters mentioned in

subsection (3).

(3) The matters are:

(a) any significant differences in the proposed use of the

constituent, or of the product, in Australia and in that foreign

country; or

(b) any different environmental factors affecting the use of the

constituent, or of the product, in Australia and in that foreign

country; or

properties of the constituent, or of the product or of any of its

Schedule 1 Approvals, registrations, permits and licences

76 Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. ,

2012

constituents, that has become available since the conduct of

those trials or experiments; or

(d) any significant differences in the way decisions or

evaluations are made in Australia and by the national

regulatory authority in that foreign country.

183 Subparagraph 160A(1)(a)(iii) of the Code set out in the

Schedule

Repeal the subparagraph.

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

Omit "an appropriate person", substitute "the applicant".

185 Subsection 160A(2) of the Code set out in the Schedule

Omit "appropriate person", substitute "applicant".

186 Subsection 160A(2) of the Code set out in the Schedule

Omit "practicable after the person", substitute "the applicant".

187 Subsection 160A(3) of the Code set out in the Schedule

Repeal the subsection.

188 Paragraphs 160A(4)(a) to (d) of the Code set out in the

Schedule

Repeal the paragraphs, substitute:

(a) contradicts any information that:

(i) was given to the APVMA by the applicant in an

application mentioned in paragraph (1)(a); and

(ii) relates to particulars prescribed by the regulations for

the purposes of paragraph 19(1)(c) or 20(1)(c); or

(b) shows that the constituent or product may not meet the safety

criteria, the trade criteria or the efficacy criteria.

189 Subsection 160A(7) of the Code set out in the Schedule

Omit "that a person has to give", substitute "given".

190 Subsection 160A(7) of the Code set out in the Schedule

Omit "an approved person", substitute "the applicant".

Approvals, registrations, permits and licences Schedule 1

Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. , 2012

191 At the end of subsection 160A(7) of the Code set out in

the Schedule

Add:

Note:

For giving information electronically, see section 156A.

192 Paragraph 161(1)(a) of the Code set out in the Schedule

Repeal the paragraph, substitute:

(a) the holder of the approval of an active constituent for a

proposed or existing chemical product or the registration of a

chemical product; or

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

Omit "person must, as soon as practicable after the person", substitute

"holder must, as soon as the holder".

194 Paragraphs 161(2)(a) to (d) of the Code set out in the

Schedule

Repeal the paragraphs, substitute:

(a) contradicts any information entered in the Record, Register

or Record of Permits for the constituent or product; or

(b) shows that the constituent or product may not meet the safety

criteria, the trade criteria or the efficacy criteria.

195 Subsection 161(3) of the Code set out in the Schedule

Omit "that a person has to give", substitute "given".

196 Subsection 161(3) of the Code set out in the Schedule

Omit "an approved person", substitute "the holder".

197 At the end of subsection 161(3) of the Code set out in the

Schedule

Add:

Note:

For giving information electronically, see section 156A.

198 Subparagraph 162(3)(a)(i) of the Code set out in the

Schedule

Omit "assessment", substitute "evaluation".

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78 Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. ,

2012

199 Subparagraph 162(3)(b)(i) of the Code set out in the

Schedule

Omit "or listed registration".

200 Subparagraph 162(3)(b)(i) of the Code set out in the

Schedule

Omit "assessment", substitute "evaluation".

201 Subparagraph 162(3)(b)(ii) of the Code set out in the

Schedule

Omit "or of the listed registration of the product under Division 6 of

Part 2A".

202 Subparagraph 162(3)(c)(ii) of the Code set out in the

Schedule

Omit "interested person in relation to the constituent or product",

substitute "applicant or holder concerned".

203 Paragraph 162(3)(d) of the Code set out in the Schedule

Omit "interested person in relation to the constituent or product",

substitute "applicant or holder concerned".

204 Subsection 162(4) of the Code set out in the Schedule

Omit "interested person" (first occurring), substitute "applicant or

holder concerned".

205 Paragraph 162(4)(a) of the Code set out in the Schedule

Omit "interested person", substitute "applicant or holder".

206 Subsection 162(5) of the Code set out in the Schedule

Repeal the subsection.

207 Section 163 of the Code set out in the Schedule

(heading)

Repeal the heading, substitute:

Approvals, registrations, permits and licences Schedule 1

Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. , 2012

163 Notice to the applicant or holder of proposed disclosure of

information that is claimed to be confidential commercial

information

208 Subsection 163(1) of the Code set out in the Schedule

Omit "(1)".

209 Paragraph 163(1)(b) of the Code set out in the Schedule

Omit "interested person in relation to the constituent, product or label",

substitute "applicant or holder concerned".

210 Paragraph 163(1)(d) of the Code set out in the Schedule

Omit "interested person", substitute "applicant or holder".

211 Subsection 163(2) of the Code set out in the Schedule

Repeal the subsection.

212 Subsection 164(10) of the Code set out in the Schedule

Repeal the subsection.

213 Paragraph 165(2)(a) of the Code set out in the Schedule

Repeal the paragraph, substitute:

(a) if the application is for re-approval of an active constituent or

re-registration of a chemical product:

(i) any period beginning on the day when the APVMA

makes a requirement of the applicant in connection with

the application and ending on the day when the

requirement is complied with; or

(ii) any period during which the approval or registration

concerned is being reconsidered as required by

subsection 29H(1); and

214 Paragraph 165(2)(b) of the Code set out in the Schedule

Omit "caused to be".

215 Paragraph 165(2)(c) of the Code set out in the Schedule

Omit "caused such a notice to be published", substitute "published such

a notice".

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80 Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. ,

2012

216 At the end of subsection 165(2) of the Code set out in the

Schedule

Add:

; and (d) if the APVMA has given written notice to an applicant under

subsection 8S(1)--the 28 day period after the notice is given,

or such further period as is specified in the notice, within

which submissions may be made.

217 At the end of section 165 of the Code set out in the

Schedule

Add:

(3) If, at the end of the period referred to in subsection (1), the

application has not been determined, the applicant may give the

APVMA written notice that the applicant wishes to treat the

application as having been refused.

(4) The notice may be given at any time after the end of the period

referred to in subsection (1) and before the application is

determined.

(5) If the notice is given, this Code has effect as if:

(a) the APVMA had refused the application; and

(b) the APVMA had confirmed the refusal under section 166;

and

made on the day on which notice was given to the APVMA

under subsection (3).

218 After section 165 of the Code set out in the Schedule

Insert:

165A Period within which APVMA is to conclude reconsiderations

under Division 4 of Part 2

(1) If the APVMA reconsiders an approval or registration under

Division 4 of Part 2, the APVMA must conclude the

reconsideration within a period stated in, or determined in

accordance with, the regulations.

Approvals, registrations, permits and licences Schedule 1

Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. , 2012

(2) The APVMA may make a legislative instrument setting out criteria

for working out which period stated in, or determined in

accordance with, the regulations applies in a particular case.

(3) In working out the period within which the reconsideration is to be

concluded, no regard is to be had to:

(a) the period, stated in the notice given to the holder under

subsection 32(1), within which information must be given

and submissions may be made; and

(b) if the APVMA has given written notice to the holder under

subsection 33(1)--the period stated in the notice within

which any information, report, results or sample must be

given to the APVMA.

219 Section 166 of the Code set out in the Schedule

(heading)

Repeal the heading, substitute:

166 Internal review of decisions

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

Omit "other than this section".

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

Repeal the paragraph, substitute:

(b) the original decision is:

(i) a decision that is reviewable by the Administrative

Appeals Tribunal (see section 167), other than a

decision under subsection 29G(1), 34A(1) or 34AA(1)

or (2); or

(ii) a decision under subsection 14(2), 26C(2), 29(2) or

29E(3) based only on requirements set out in paragraph

8A(a) or (b); or

(iii) a decision under subsection 112(3) based only on

requirements set out in paragraph 8A(a) or (b) or a

requirement made by the APVMA under subparagraph

111(1)(b)(iii).

222 Subsection 166(3) of the Code set out in the Schedule

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82 Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. ,

2012

Omit "decision and", substitute "decision having regard only to the

information used to make it, and must".

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

Repeal the subsection.

224 Section 167 of the Code set out in the Schedule

(heading)

Repeal the heading, substitute:

167 Review of decisions by Administrative Appeals Tribunal

225 Paragraphs 167(1)(aa) to (e) of the Code set out in the

Schedule

Repeal the paragraphs, substitute:

(a) a decision under subsection 14(1) to approve or register a

constituent, product or label:

(i) with an instruction or relevant particular other than an

instruction or particular set out in the application for the

approval or registration; or

(ii) subject to particular conditions;

(b) a decision under subsection 14(2) to refuse an application for

approval or registration, other than a decision based only on

requirements set out in paragraph 8A(a) or (b);

vary relevant particulars, other than a decision based only on

requirements set out in paragraph 8A(a) or (b);

(d) a decision under subsection 29(2) to refuse an application to

vary relevant particulars or conditions, other than a decision

based only on requirements set out in paragraph 8A(a) or (b);

(da) a decision under subsection 29D(3) to refuse to accept a late

application;

(db) a decision under subsection 29G(1) to vary relevant

particulars or conditions;

(e) a decision under subsection 34A(1) or 34AF(3) to vary

relevant particulars or conditions;

226 Paragraph 167(1)(ea) of the Code set out in the Schedule

Omit "34D(3)", substitute "34J(3)".

Approvals, registrations, permits and licences Schedule 1

Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. , 2012

227 Paragraph 167(1)(ea) of the Code set out in the Schedule

Omit "34C", substitute "34G".

228 Paragraph 167(1)(ea) of the Code set out in the Schedule

Omit all the words from and including "substantive decision)",

substitute "substantive decision);".

229 Paragraph 167(1)(f) of the Code set out in the Schedule

After "under", insert "section 34AA or".

230 Paragraphs 167(1)(fa) to (ff) of the Code set out in the

Schedule

Repeal the paragraphs.

231 Paragraph 167(1)(g) of the Code set out in the Schedule

Omit "or 56ZL(3)".

232 At the end of paragraph 167(1)(l) of the Code set out in

the Schedule

Add ", other than a decision based only on requirements set out in

paragraph 8A(a) or (b) or a requirement made by the APVMA under

subparagraph 111(1)(b)(iii)".

233 Paragraphs 167(1)(o) and (p) of the Code set out in the

Schedule

Repeal the paragraphs, substitute:

(o) a decision under section 118, 119, 119A or 119B to suspend

or cancel a permit;

234 Paragraph 167(1)(u) of the Code set out in the Schedule

Repeal the paragraph.

235 Paragraph 167(1)(v) of the Code set out in the Schedule

Omit "interested person", substitute "applicant or holder".

236 Subsection 167(2) of the Code set out in the Schedule

Repeal the subsection.

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84 Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. ,

2012

237 Subsection 167(2A) of the Code set out in the Schedule

Omit "34E", substitute "34K".

238 Subsection 167(2A) of the Code set out in the Schedule

Omit "to public health or occupational health or safety", substitute "to

persons of death, serious injury or serious illness".

239 Subparagraph 178(1)(a)(ii) of the Code set out in the

Schedule

Omit "of Chemical Products".

240 Paragraphs 180(c) and (ca) of the Code set out in the

Schedule

Omit "32(2)", substitute "32(1)".

241 Paragraph 184(a) of the Code set out in the Schedule

Repeal the paragraph.

242 After paragraph 184(b) of the Code set out in the

Schedule

Insert:

; and (c) the person had not complied with the notice before that

commencement;

243 Section 184 of the Code set out in the Schedule

Omit "and the person had not complied with the notice before that

commencement,".

Re-approvals and re-registrations Schedule 2

Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. , 2012

Schedule 2--Re-approvals and

re-registrations

Agricultural and Veterinary Chemicals Code Act 1994

1 Subsection 3(1) of the Code set out in the Schedule

(definition of approval)

Repeal the definition, substitute:

approval means approval under Part 2 of:

(a) an active constituent for a proposed or existing chemical

product; or

(b) a label for containers for a chemical product;

and, in relation to an active constituent, other than in Division 2 of

Part 2 and Part 3, includes re-approval.

2 Subsection 3(1) of the Code set out in the Schedule

Insert:

re-approval means re-approval of an active constituent under

Division 3A of Part 2.

3 Subsection 3(1) of the Code set out in the Schedule

(definition of registration)

Repeal the definition, substitute:

registration means registration under Part 2 of a chemical product

and, other than in Division 2 of Part 2 and Part 3, includes

re-registration.

4 Subsection 3(1) of the Code set out in the Schedule

Insert:

re-registration means re-registration of a chemical product under

Division 3A of Part 2.

5 After Division 3 of Part 2 of the Code set out in the

Schedule

Insert:

Schedule 2 Re-approvals and re-registrations

86 Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. ,

2012

Division 3A--Re-approving and re-registering

29C Explanation of Division

(1) This Division provides for re-approval and re-registration of active

constituents and chemical products.

(2) Section 29D provides for holders of approvals and registrations to

make applications, and sets out the time for making applications.

Applications must meet the application requirements specified in

section 8A.

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

application. If the application passes preliminary assessment, the

APVMA must notify the applicant (section 29E).

(4) Section 29F sets out the circumstances in which the APVMA must

re-approve or re-register an active constituent or chemical product.

(5) The APVMA may vary relevant particulars or conditions to allow

re-approval or re-registration (section 29G).

(6) If the APVMA does not re-approve or re-register an active

constituent or chemical product, it must reconsider the existing

approval or registration under Division 4 (section 29H).

(7) Sections 29J and 29K set out how re-approval and re-registration

take place.

29D Applications

(1) The holder of the approval of an active constituent or the

registration of a chemical product may apply for re-approval or

re-registration of the constituent or product.

(2) The application must:

(a) meet the application requirements; and

(b)

made:

(i) for re-approval--not earlier than 6 calendar months, and

not later than 3 calendar months, before the date entered

in the Record as the date the approval ends; or

(ii) for re-registration--not earlier than 6 calendar months,

and not later than 3 calendar months, before the date

Re-approvals and re-registrations Schedule 2

Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. , 2012

entered in the Register as the date after which the

registration cannot be renewed under Division 6; or

(iii) within such further period as the APVMA allows under

subsection (3).

Note: For

meets the application requirements, see section 8A.

(3) In circumstances prescribed by the regulations and upon payment

of the prescribed fee (if any), the APVMA may accept a late

application if the application is made on or before:

(a) for re-approval--the day the approval ends; or

(b) for re-registration--the day after which the registration

cannot be renewed under Division 6.

(4) Subsection (1) has effect subject to any condition imposed on the

approval or registration under subsection 23(2).

Note:

Subsection 23(2) provides for an approval or registration to last for not

more than one year.

29E Preliminary assessment

(1) The APVMA must complete a preliminary assessment of the

application within 2 months after it is lodged.

(2) If it appears from the preliminary assessment that the application

meets the application requirements, the APVMA must, within 14

days, give written notice to the applicant:

(a) stating that the application has passed preliminary assessment

and that it will be determined under section 29F; and

(b) setting out any matters prescribed by the regulations.

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

Note:

For notice of refusal, see section 8G.

(4) The APVMA may alter the application, after it has passed

preliminary assessment, with the written consent of the applicant.

29F Re-approval or re-registration

(1) If the application is for re-approval of an active constituent, the

APVMA must re-approve the constituent unless it appears to the

APVMA that there are reasonable grounds to believe that the

constituent does not meet the safety criteria.

Schedule 2 Re-approvals and re-registrations

88 Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. ,

2012

Note:

For notice of re-approval, see section 8F.

(2) If the application is for re-registration of a chemical product, the

APVMA must re-register the product unless it appears to the

APVMA that there are reasonable grounds to believe that the

product does not do one or more of the following:

(a) meet the safety criteria;

(b) meet the trade criteria;

Note:

For notice of re-registration, see section 8F.

(3) For the purposes of subsections (1) and (2), the APVMA must have

regard to any submission given in response to a notice in relation to

the constituent or product under section 47B (advance notice of

end of approval or registration).

29G Varying relevant particulars and conditions to allow

re-approval or re-registration

(1) To allow the re-approval or re-registration, the APVMA may:

(a) vary the relevant particulars or conditions of the approval or

registration; or

(b) for a chemical product--vary the relevant particulars or

conditions of the approval of any label for the product.

Note:

The APVMA may only vary relevant particulars or conditions that it

has imposed. See section 6B.

(2) If the variation would affect any instructions for the use of the

active constituent or chemical product, or any instructions on a

label, the APVMA must not make the variation until it has

consulted each co-ordinator designated for a jurisdiction and taken

into account any recommendations made by the co-ordinators.

(3) If the APVMA decides to vary the relevant particulars or

conditions, it must record in the Record, Register or relevant

APVMA file, as required, the relevant particulars or conditions as

varied and the date on which the variation is made.

(4) If the relevant particulars or conditions of the registration of a

listed chemical product are varied in such a way that the product

and every label for the product comply with the established

standard for the product, the APVMA must remove from the

Re-approvals and re-registrations Schedule 2

Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. , 2012

be renewed under Division 6.

29H Reconsideration if APVMA does not re-approve or re-register

(1) If the APVMA does not re-approve or re-register the active

constituent or chemical product it must:

(a) reconsider the existing approval or registration under

Division 4; and

(b) give written notice of the reconsideration to the holder within

14 days.

(2) The notice must:

(a) set out the reasons for the reconsideration; and

(b)

state

that:

(i) for an approval--the approval will not end until the

reconsideration has been concluded; or

(ii) for a registration--the date after which the registration

cannot be renewed under Division 6 will be the day on

which the reconsideration is concluded; and

reconsideration, the active constituent or chemical product

will be re-approved or re-registered.

(3) The notice may be included with the notice in relation to the

reconsideration given under subsection 32(1).

29J How re-approval takes place

(1) Re-approval of an active constituent takes place when the APVMA

records the following in the Record:

(a) a statement that the constituent has been re-approved and the

date of the re-approval;

(b) the date the approval (as re-approved) ends.

(2) The date the approval ends must:

(a) be worked out in accordance with the method prescribed by

the regulations; and

(b) be the last day of a calendar month at least 7 years but not

more than 15 years after the re-approval takes place.

Schedule 2 Re-approvals and re-registrations

90 Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. ,

2012

(3) Despite subsection (2), the APVMA may re-approve the active

constituent for a period of less than 7 years to provide for the

approval to end at the same time as another approval of the active

constituent.

(4) Paragraph (2)(b) does not apply if the approval is subject to the

condition that it remains in force only for a stated period of not

more than 1 year (see subsection 23(2)).

29K How re-registration takes place

(1) Re-registration of a chemical product takes place when the

APVMA records the following in the Register:

(a) a statement that the product has been re-registered and the

date of the re-registration;

(b) the date the registration (as re-registered) ends, which must

be the last day of a calendar month not more than 12 months

after the re-registration takes place;

the established standard for the product--the date (the last

renewal date) after which the registration cannot be renewed

under Division 6.

(2) The last renewal date must:

(a) be worked out in accordance with the method prescribed by

the regulations; and

(b) be the last day of a calendar month at least 7 years but not

more than 15 years after the re-registration takes place.

(3) However, the last renewal date may be less than 7 years after the

re-registration takes place to provide for the last renewal date to be

the same as the last renewal date for another chemical product that

contains one or more of the same active constituents.

(4) Paragraph (2)(b) does not apply if the registration is subject to the

condition that it remains in force only for a stated period of not

more than 1 year (see subsection 23(2)).

6 Division 6 of Part 2 of the Code set out in the Schedule

(heading)

Repeal the heading, substitute:

Re-approvals and re-registrations Schedule 2

Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. , 2012

Division 6--Duration of approvals and registrations and

renewal of registrations

7 Section 47 of the Code set out in the Schedule

Repeal the section, substitute:

Subdivision A--Preliminary

46A Explanation of Division

(1) This Division deals with the duration of approvals and

registrations, and with renewing registrations.

(2) Section 47 sets out the periods for which approvals and

registrations are in force.

(3) Section 47A provides for the APVMA to vary the duration of the

approval of an active constituent or the registration of a chemical

product containing an active constituent if 2 or more foreign

regulators have prohibited the use of the active constituent on

safety grounds.

(4) The APVMA must publish at least 12 months' advance notice of:

(a) the end of an approval; and

(b) the date after which a registration cannot be renewed

(section 47B).

The APVMA may give less than 12 months' notice if it varied the

date under section 47A.

(5) The APVMA must publish notice of the end of an approval or

registration as soon as practicable after the approval or registration

has ended (section 47C).

(6) If the APVMA publishes notice of the end of the approval or

registration of a constituent or a product under section 47C, then:

(a) certain persons are taken to have a permit to possess, have

custody of or use of the constituent or product for a limited

period (section 47D); and

(b) persons may only supply the constituent or product in

accordance with instructions contained in the notice

(section 47E).

Schedule 2 Re-approvals and re-registrations

92 Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. ,

2012

(7) Section 48 provides for applications for renewal of a registration.

(8) The APVMA must renew the registration if the application

requirements are met (section 49).

(9) Renewal takes place by entry in the Register (section 50).

(10) The approval of a label for a container for a chemical product is

automatically renewed when the registration of the product is

renewed (section 51).

Subdivision B--Period of approval or registration

47 Period of approval or registration

(1) The approval of an active constituent ends on the later of the

following days:

(a) the day entered in the Record as the date the approval ends;

(b) if an application is made for re-approval of the active

constituent but is not determined by the day entered in the

Record--the day on which the application is determined.

(2) The registration of a chemical product ends on the later of the

following days:

(a) the day entered in the Register as the date the registration

ends;

(b) if an application is made for renewal of the registration but is

not determined by the day entered in the Register--the day

on which the application is determined.

(3) The registration of a chemical product also ends if the approval of

an active constituent for the product ends.

(4) The approval of a label for containers for a chemical product ends

when the registration of the product ends.

(5)

If:

(a) the registration of a chemical product ends; but

(b) a person is taken under section 47D to have been issued with

a permit to possess, have custody of or use the product;

the approval of a label for containers for the product continues in

force until the permit ceases to have effect.

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Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. , 2012

(6) To avoid doubt, this section does not limit any power under this

Code to cancel or suspend an approval or registration.

47A Varying duration--decisions of foreign regulators

(1) This section applies if:

(a) regulators of agricultural or veterinary chemicals of 2 or

more foreign countries, being regulators who are prescribed

by the regulations, have decided, within a 7 year period, to

prohibit all uses of:

(i) the same active constituent; or

(ii) one or more chemical products containing the same

active constituent; and

(b) the uses were prohibited because the active constituent:

(i) was an undue hazard to the safety of people exposed to

it during its handling or people using anything

containing its residues; or

(ii) was likely to have an effect that is harmful to human

beings; or

(iii) was likely to have an unintended effect that is harmful

to animals, plants or things or to the environment; and

(i) approved under this Code, but not approved or

re-approved after the first of those decisions; or

(ii) contained in a chemical product that is registered under

this Code, but not registered or re-registered after the

first of those decisions; and

(d) the approval or registration is not being reconsidered under

Division 4.

(2) The APVMA must vary the following as necessary to meet the

requirement in subsection (3):

(a) the date (the end date) entered in the Record or Register as

the day the approval or registration ends;

(b) for a chemical product for which there is a date entered in the

cannot be renewed under Division 6--that date (the last

renewal date).

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94 Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. ,

2012

(3) The end date and last renewal date (if applicable) must be the last

day of a calendar month in the period that begins 6 months and

ends 18 months after the second of those decisions was made.

(4) Neither the end date nor the last renewal date may be varied again

under this section.

(5) If the end date or last renewal date is varied, the holder must be

given written notice of the date as varied at least 6 months before it

occurs.

(6) This section does not apply to extend:

(a) the duration of the approval or registration; or

(b) the period before the day after which the registration cannot

be renewed.

Subdivision C--Notifying end of approvals and registrations

47B Advance notice of end of approval or registration

(1) The APVMA must publish in the Gazette at least 12 months'

notice of the following:

(a) the end of the approval of an active constituent;

(b) the date after which the registration of a chemical product

cannot be renewed under this Division.

(2) The notice must:

(a) invite submissions about whether or not:

(i) the constituent should be re-approved; or

(ii) the product should be re-registered; and

(b) specify the time by which the submissions must be given to

the APVMA, which must be no later than 6 months before

the existing approval or registration ends.

(3) The APVMA must give the holder at least 12 months' notice of:

(a) the end of the approval of an active constituent; and

(b) the date after which the registration of a chemical product

cannot be renewed under this Division.

(4) The notice must:

(a) set out the relevant particulars and conditions of the approval

or registration; and

Re-approvals and re-registrations Schedule 2

Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. , 2012

(b)

state:

(i) the date the approval ends; or

(ii) the date after which the registration cannot be renewed

under this Division; and

(5) The APVMA may give less than 12 months' notice if, under

section 47A, the APVMA varied:

(a) the date the approval or registration ends; or

(b) the date after which the registration cannot be renewed under

this Division.

47C Notice of end of approval or registration

(1) The APVMA must publish in the Gazette, and in any other manner

that it thinks appropriate, notice of the following:

(a) the end of the approval of an active constituent;

(b) the end of the registration of a chemical product.

(2) The notice must:

(a) be published as soon as practicable after the approval or

registration ends; and

(b) state that the approval or registration has ended; and

and

(d) contain instructions for possessing, having custody of or

using the constituent or product; and

(e) contain a warning of the consequences if a person fails to

comply with the instructions, including a statement of any

period after which it will be an offence against this Code to

supply the constituent or product or to possess or have

custody of the constituent or product with the intention of

supplying it; and

(f) contain any other warnings or explanations in relation to the

constituent or product that the APVMA thinks desirable; and

(g) contain any other information that the APVMA thinks

appropriate.

(3) Subsection (1) does not apply if the APVMA thinks that, in the

circumstances, it is unnecessary to publish the notice.

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96 Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. ,

2012

(4) If a notice is published under this section, the APVMA must:

(a) as soon as practicable cause a copy of the notice to be given

to the holder; and

(b) cause a copy of the notice to be given to any other person

who, in the opinion of the APVMA, should be given notice

of the ending of the approval or registration and of the

instructions, warnings and explanations contained in the

notice.

47D Permit taken to have been issued

(1) If, after the publication of a notice under section 47C, a person

possesses, has custody of or uses the constituent or product in

accordance with the instructions contained in the notice, the person

is taken to have been issued with a permit to possess, have custody

of or use the constituent or product in accordance with those

instructions until:

(a) 1 year after the day on which the approval or registration

ended; or

(b) the APVMA, by notice published in the Gazette, declares that

this subsection ceases to apply in respect of the constituent or

product;

whichever first occurs.

(2) A permit that is taken to have been issued to a person under

subsection (1) does not authorise the person to manufacture or

import the constituent or product.

47E Possession or custody with intention of supply

(1) This section applies if, after the publication of a notice under

section 47C, a person has possession or custody of the constituent

or product with the intention of supplying it.

(2) The person must not possess, have custody of or otherwise deal

with the constituent or product except in accordance with the

instructions contained in the notice.

(3) Subsection (2) does not apply to a possession, custody or dealing if

the constituent or product was approved or registered when the

possession, custody or dealing took place because of its having

Re-approvals and re-registrations Schedule 2

Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. , 2012

been approved or registered or having become reserved after its

previous approval or registration ended.

(4) A person commits an offence if the person contravenes

subsection (2).

Penalty: 300 penalty units.

Note:

A defendant bears an evidential burden in relation to the matter in

subsection (3). See subsection 13.3(3) of the Criminal Code.

(5) For the purposes of subsection (4), strict liability applies to the

physical element of circumstance in subsection (1), that the

publishing of the notice was under section 47C.

Note:

For strict liability, see section 6.1 of the Criminal Code.

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

Note 1:

Division 2 of Part 9A provides for pecuniary penalties for

contraventions of civil penalty provisions.

Note 2:

For the evidential burden in civil penalty proceedings in relation to the

matter in subsection (3), see section 145CD.

Subdivision D--Renewing registrations

8 Section 48 of the Code set out in the Schedule (heading)

Repeal the heading, substitute:

48 Applications

9 Subsection 48(1) of the Code set out in the Schedule

Omit "interested person", substitute "holder".

10 Subsection 48(2) of the Code set out in the Schedule

Repeal the subsection, substitute:

(2) The application (the renewal application) must be made:

(a) subject to subsection (3), not later than one month, or a

shorter period that the APVMA permits, before the

registration ends; and

(b) before the day entered in the Register as the day after which

the registration cannot be renewed under this Division.

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98 Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. ,

2012

11 At the end of section 48 of the Code set out in the

Schedule

Add:

(4) If an application (the re-registration application):

(a) has been made for re-registration of the chemical product; but

(b) has not been determined before the day by which the renewal

application must be made;

the day entered in the Register as the day after which the

registration cannot be renewed under this Division is taken to be

the day on which the re-registration application is determined.

(5) The APVMA may alter the renewal application with the written

consent of the holder.

(6) Subsection (1) has effect subject to any condition imposed on the

registration under subsection 23(2).

Note:

Subsection 23(2) provides for an approval or registration to last for not

more than one year.

12 Sections 49 and 50 of the Code set out in the Schedule

Repeal the sections, substitute:

49 Renewal of registration

(1) If the APVMA is satisfied that the renewal application meets the

application requirements, the APVMA must renew the registration:

(a) if the application was made in accordance with subsection

48(2)--before the day entered in the Register as the day the

registration ends; or

(b) if the application was made in accordance with subsection

48(3)--within 1 month after the application was made.

Note:

For notice of renewal, see section 8F.

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

Note:

For notice of refusal, see section 8G.

50 How renewal takes place

Renewal of the registration of a chemical product takes place when

the APVMA enters in the Register a statement that the registration

Schedule 3 Enforcement

100 Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. ,

2012

Schedule 3--Enforcement

Agricultural and Veterinary Chemical Products (Collection

of Levy) Act 1994

1 Subsection 3(1)

Insert:

civil penalty order has the same meaning as in the Agricultural and

Veterinary Chemicals (Administration) Act 1992.

2 Subsection 3(1)

Insert:

civil penalty provision means a provision declared by this Act to

be a civil penalty provision.

3 Subsection 3(1) (definition of occupier)

Repeal the definition.

4 Subsection 3(1) (definition of premises)

Repeal the definition.

5 Subsection 15(2) (penalty)

Repeal the penalty.

6 After subsection 15(2)

Insert:

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

contravenes subsection (2).

Penalty: 50 penalty units.

Note:

For strict liability, see section 6.1 of the Criminal Code.

7 Subsection 15(2A)

Omit "Subsection (2)", substitute "Subsection (2AA)".

8 Subsection 15(2B)

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Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. , 2012

101

Repeal the subsection, substitute:

(2B) Subsection (2) 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 this provision, see

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

Chemicals (Administration) Act 1992.

9 Subsection 20(3) (penalty)

Repeal the penalty.

10 After subsection 20(3)

Insert:

(3A) A person commits an offence of strict liability if the person

contravenes subsection (3).

Penalty: 50 penalty units.

Note:

For strict liability, see section 6.1 of the Criminal Code.

11 Subsection 20(4)

Omit "Subsection (3)", substitute "Subsection (3A)".

12 Subsection 20(5)

Repeal the subsection, substitute:

(5) Subsection (3) 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 this provision, see

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

Chemicals (Administration) Act 1992.

Schedule 3 Enforcement

102 Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. ,

2012

13 Sections 21 to 32

Repeal the sections.

14 Section 34

Repeal the section, substitute:

34 Self-incrimination etc.

(1) A person is not excused from:

(a) giving information; or

(b) producing a document or thing; or

under this Act on the ground that doing so might tend to

incriminate the person or expose the person to a penalty.

(2) However, in the case of an individual, none of the following:

(a) the information or answer given;

(b) the document or thing produced;

of the document or thing;

(d) any information, document or thing obtained as a direct or

indirect consequence of giving the information or answer, or

producing the document or thing;

is admissible in evidence against the individual in:

(e) criminal proceedings, other than:

(i) proceedings for an offence against section 137.1 or

137.2 of the Criminal Code (which deal with false or

misleading information or documents) that relates to

this Act; or

(ii) proceedings for an offence against section 149.1 of the

Criminal Code (which deals with obstruction of

Commonwealth public officials) that relates to this Act;

(f) civil proceedings for a contravention of a civil penalty

provision.

15 Section 35

Repeal the section.

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Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. , 2012

103

16 Subsection 36(1) (penalty)

Repeal the penalty.

17 Subsection 36(2)

Repeal the subsection, substitute:

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

contravenes subsection (1).

Penalty: 50 penalty units.

Note:

For strict liability, see section 6.1 of the Criminal Code.

(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 this provision, see

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

Chemicals (Administration) Act 1992.

Agricultural and Veterinary Chemicals (Administration) Act

1992

18 Section 4

Insert:

civil penalty order has the meaning given by subsection 69EJ(4).

19 Section 4

Insert:

civil penalty provision means a provision declared by this Act or

the Collection Act to be a civil penalty provision.

20 Section 4

Insert:

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104 Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. ,

2012

Collection Act means the Agricultural and Veterinary Chemical

Products (Collection of Levy) Act 1994.

21 Section 4

Insert:

confidential commercial information has the same meaning as in

the Code set out in the Schedule to the Agricultural and Veterinary

Chemicals Code Act 1994.

22 Section 4

Insert:

copy, in relation to a warrant issued under section 69EH or 69EHA

(or a form of warrant completed under subsection 69EHB(6)),

includes:

(a) a copy sent by fax or other electronic means; or

(b) a copy of a copy so sent.

23 Section 4

Insert:

damage has the same meaning as in the Code set out in the

Schedule to the Agricultural and Veterinary Chemicals Code Act

1994.

24 Section 4

Insert:

data has the same meaning as in the Code set out in the Schedule

to the Agricultural and Veterinary Chemicals Code Act 1994.

25 Section 4

Insert:

evidential burden, in relation to a matter, means the burden of

adducing or pointing to evidence that suggests a reasonable

possibility that the matter exists or does not exist.

26 Section 4

Insert:

Enforcement Schedule 3

Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. , 2012

105

evidential material means any of the following:

(a) a thing with respect to which an offence against this Act or

the Collection Act has been committed or is suspected, on

reasonable grounds, to have been committed;

(b) a thing with respect to which a civil penalty provision has

been contravened or is suspected, on reasonable grounds, to

have been contravened;

afford evidence as to the commission of such an offence or

contravention of such a civil penalty provision;

(d) a thing that there are reasonable grounds for suspecting is

intended to be used for the purpose of committing such an

offence or contravening such a civil penalty provision.

27 Section 4

Insert:

executive officer of a body corporate means a person, by whatever

name called and whether or not a director of the body, who is

concerned in, or takes part in, the management of the body.

28 Section 4

Insert:

investigation powers has the meaning given by sections 69EBA,

69EBB and 69EBC.

29 Section 4

Insert:

investigation warrant means:

(a) a warrant issued under section 69EHA; or

(b) a warrant signed by a magistrate under section 69EHB, being

a warrant of the same kind as would have been issued under

section 69EHA.

30 Section 4

Insert:

monitoring powers has the meaning given by sections 69EAC,

69EAD and 69EAE.

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106 Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. ,

2012

31 Section 4

Insert:

monitoring warrant means:

(a) a warrant issued under section 69EH; or

(b) a warrant signed by a magistrate under section 69EHB, being

a warrant of the same kind as would have been issued under

section 69EH.

32 Section 4

Insert:

occupier has the same meaning as in the Code set out in the

Schedule to the Agricultural and Veterinary Chemicals Code Act

1994.

33 Section 4

Insert:

person assisting an inspector:

(a) in relation to the exercise of monitoring powers--has the

meaning given by section 69EAF; and

(b) in relation to the exercise of investigation powers--has the

meaning given by section 69EBD.

34 Section 4

Insert:

premises has the same meaning as in the Code set out in the

Schedule to the Agricultural and Veterinary Chemicals Code Act

1994.

35 Section 4

Insert:

prescribed civil penalty provision means a civil penalty provision

that is prescribed by the regulations.

36 Section 4

Insert:

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Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 No. , 2012

107

relevant data means information relevant to determining whether:

(a) this Act, or the Collection Act, has been, or is being,

complied with; or

(b) information provided under this Act, or the Collection Act, is

correct; or

37 Section 4

Insert:

warrant means a monitoring warrant or an investigation warrant.

38 After subsection 11(1)

Insert:

(1A) The APVMA may only delegate its powers under section 130 or

section 131AA of the Code set out in the Schedule to the

Agricultural and Veterinary Chemicals Code Act 1994 to a

member of staff who is an SES, or acting SES, employee.

39 After paragraph 59(c)

Insert:

(ca) any amounts paid to the APVMA, on behalf of the

Commonwealth, under section 149A of the Agvet Codes;

40 After paragraph 61(2)(c)

Insert:

(ca) particulars of any exercise of powers under section 131AA of

the Code set out in the Schedule to the Agricultural and

Veterinary Chemicals Code Act 1994 during that year;

41 Subsection 69A(1)

Omit "(1)".

42 Subsection 69A(2)

Repeal the subsection.

43 Before section 69B

Insert:

Commonwealth of Australia Bills

AGRICULTURAL AND VETERINARY CHEMICALS LEGISLATION AMENDMENT BILL 2013