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A Bill for an Act to amend the law relating to agricultural and veterinary chemicals, and for related purposes
Administered by: Agriculture and Water Resources
For authoritative information on the progress of bills and on amendments proposed to them, please see the House of Representatives Votes and Proceedings, and the Journals of the Senate as available on the Parliament House website.
Registered 18 Oct 2018
Introduced HR 18 Oct 2018
Table of contents.

2016‑2017‑2018

 

The Parliament of the

Commonwealth of Australia

 

HOUSE OF REPRESENTATIVES

 

 

 

 

Presented and read a first time

 

 

 

 

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

 

No.      , 2018

 

(Agriculture and Water Resources)

 

 

 

A Bill for an Act to amend the law relating to agricultural and veterinary chemicals, and for related purposes

  

  


Contents

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

2............ Commencement................................................................................... 1

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

Schedule 1—Main amendments                                                                                    4

Part 1—Approval and registration for prescribed active constituents, chemical products or labels          4

Agricultural and Veterinary Chemicals Code Act 1994                                      4

Part 2—Information to be taken into account in determining applications           11

Agricultural and Veterinary Chemicals Code Act 1994                                    11

Part 3—Limits on use of information                                                                 12

Agricultural and Veterinary Chemicals Code Act 1994                                    12

Part 4—Computerised decision‑making                                                            16

Agricultural and Veterinary Chemicals Code Act 1994                                    16

Part 5—Accreditation of assessors                                                                       19

Agricultural and Veterinary Chemicals (Administration) Act 1992               19

Agricultural and Veterinary Chemicals Code Act 1994                                    19

Part 6—Voluntary recalls                                                                                          23

Agricultural and Veterinary Chemicals Code Act 1994                                    23

Part 7—Notification of new information                                                          25

Agricultural and Veterinary Chemicals Code Act 1994                                    25

Part 8—Definition of registered chemical product                                      27

Agricultural and Veterinary Chemicals Code Act 1994                                    27

Part 9—Suspension or cancellation of approval or registration for provision of false or misleading information                                                                                                     30

Agricultural and Veterinary Chemicals Code Act 1994                                    30

Part 10—Supply of registered chemical products with unapproved label              31

Agricultural and Veterinary Chemicals Code Act 1994                                    31

Part 11—Variation of approval or registration during suspension       33

Agricultural and Veterinary Chemicals Code Act 1994                                    33

Part 12—Safety, efficacy, trade and labelling criteria                               35

Agricultural and Veterinary Chemicals Code Act 1994                                    35

Part 13—Annual operational plans                                                                       36

Agricultural and Veterinary Chemicals (Administration) Act 1992               36

Part 14—Other amendments                                                                                   38

Agricultural and Veterinary Chemicals (Administration) Act 1992               38

Agricultural and Veterinary Chemicals Code Act 1994                                    39

Agricultural and Veterinary Chemicals Legislation Amendment Act 2013   43

Schedule 2—Other amendments                                                                                 44

Part 1—Amendments                                                                                                  44

Agricultural and Veterinary Chemicals Code Act 1994                                    44

Part 2—Repeals                                                                                                              45

Agricultural and Veterinary Chemicals Legislation Amendment (Removing Re‑approval and Re‑registration) Act 2014                                                                                                                                       45

 

 


A Bill for an Act to amend the law relating to agricultural and veterinary chemicals, and for related purposes

The Parliament of Australia enacts:

1  Short title

                   This Act is the Agricultural and Veterinary Chemicals Legislation Amendment (Streamlining Regulation) Act 2018.

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.

 

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1.  Sections 1 to 3 and anything in this Act not elsewhere covered by this table

The day this Act receives the Royal Assent.

 

2.  Schedule 1, Parts 1 and 2

The day after the end of the period of 6 months beginning on the day this Act receives the Royal Assent.

 

3.  Schedule 1, Part 3

A single day to be fixed by Proclamation.

However, if the provisions do not commence within the period of 6 months beginning on the day this Act receives the Royal Assent, they commence on the day after the end of that period.

 

4.  Schedule 1, Part 4

A single day to be fixed by Proclamation.

However, if the provisions do not commence within the period of 6 months beginning on the day this Act receives the Royal Assent, they commence on the day after the end of that period.

 

5.  Schedule 1, Part 5

The day after the end of the period of 12 months beginning on the day this Act receives the Royal Assent.

 

6.  Schedule 1, Parts 6 and 7

The day after the end of the period of 3 months beginning on the day this Act receives the Royal Assent.

 

7.  Schedule 1, Parts 8 to 10

The day after this Act receives the Royal Assent.

 

8.  Schedule 1, Part 11

The later of:

(a) the start of the day after this Act receives the Royal Assent; and

(b) immediately after the commencement of Part 4 of Schedule 1 to the Agricultural and Veterinary Chemicals Legislation Amendment (Operational Efficiency) Act 2018.

However, the provisions do not commence at all if the event mentioned in paragraph (b) does not occur.

 

9.  Schedule 1, Part 12

The day after this Act receives the Royal Assent.

 

10.  Schedule 1, Part 13

1 January 2020.

1 January 2020

11.  Schedule 1, Part 14

The day after this Act receives the Royal Assent.

 

12.  Schedule 2

The day after this Act receives the Royal Assent.

 

Note:          This table relates only to the provisions of this Act as originally enacted. It will not be amended to deal with any later amendments of this Act.

             (2)  Any information in column 3 of the table is not part of this Act. Information may be inserted in this column, or information in it may be edited, in any published version of this Act.

3  Schedules

                   Legislation that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms.

Schedule 1Main amendments

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

Agricultural and Veterinary Chemicals Code Act 1994

1  Section 3 of the Code set out in the Schedule

Insert:

prescribed active constituent has the meaning given by subsection 14C(4).

prescribed chemical product has the meaning given by subsection 14D(4).

prescribed label for containers for a chemical product has the meaning given by subsection 14E(4).

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

Insert:

Subdivision AExplanation of Division

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

Repeal the subsections, substitute:

Approval and registration for active constituents, chemical products or labels after assessment

             (2)  Subdivision B provides for approval and registration for active constituents, chemical products or labels after assessment against certain criteria. Section 10 provides for applications to be made and applications must meet the application requirements in section 8A.

             (3)  The APVMA must complete a preliminary assessment of an application. If the application passes preliminary assessment, the APVMA must notify the applicant and publish a summary of the application (section 11).

             (4)  Before determining certain applications that have passed preliminary assessment, the APVMA must publish a notice inviting public submissions (sections 12 and 13).

             (5)  The APVMA must approve an active constituent or label, or register a chemical product, if specified criteria are met (section 14).

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

          (5A)  Subdivision C provides for approval and registration for a prescribed active constituent, prescribed chemical product or prescribed label for containers for a chemical product. Sections 14C, 14D and 14E provide for applications to be made and applications must meet the application requirements in section 8A.

          (5B)  If an application meets the application requirements, the APVMA must approve the active constituent or label, or register the chemical product, if no disqualifying circumstances exist in relation to the applicant.

Common provisions

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

Insert:

Subdivision BApproval and registration for active constituents, chemical products or labels after assessment

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

Insert:

Subdivision CApproval and registration for prescribed active constituents, chemical products or labels

14C  Applications for approval of prescribed active constituents

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

Note:          For prescribed active constituent, see subsection (4).

             (2)  The application must meet the application requirements.

Note:          For meets the application requirements, see section 8A.

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

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

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

                     (b)  is of a kind:

                              (i)  prescribed by the regulations for the purposes of this subparagraph; or

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

             (5)  The APVMA must not determine a kind of active constituent under subsection (6) unless it is satisfied that the kind of active constituent would meet the safety criteria.

             (6)  The APVMA may, by legislative instrument, determine a kind of active constituent for the purposes of subparagraph (4)(b)(ii).

Decision on application

             (7)  The APVMA must approve the active constituent that is the subject of the application if it is satisfied that:

                     (a)  the application meets the application requirements; and

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

                     (c)  none of the circumstances determined in an instrument under subsection (9) apply in relation to the applicant.

Note:          For notice of approval, see section 8F.

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

Note:          For notice of refusal, see section 8G.

Disqualifying circumstances

             (9)  The APVMA may, by legislative instrument, determine circumstances for the purposes of paragraph (7)(c).

14D  Applications for registration of prescribed chemical products

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

Note:          For prescribed chemical product, see subsection (4).

             (2)  The application must meet the application requirements.

Note:          For meets the application requirements, see section 8A.

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

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

                     (a)  prescribed by the regulations for the purposes of this paragraph; or

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

             (5)  The APVMA must not determine a kind of chemical product under subsection (6) unless it is satisfied that the kind of chemical product would:

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

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

             (6)  The APVMA may, by legislative instrument, determine a kind of chemical product for the purposes of paragraph (4)(b).

Decision on application

             (7)  The APVMA must register the chemical product that is the subject of the application if it is satisfied that:

                     (a)  the application meets the application requirements; and

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

                     (c)  none of the circumstances determined in an instrument under subsection (9) apply in relation to the applicant.

Note:          For notice of approval, see section 8F.

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

Note:          For notice of refusal, see section 8G.

Disqualifying circumstances

             (9)  The APVMA may, by legislative instrument, determine circumstances for the purposes of paragraph (7)(c).

14E  Applications for approval of prescribed labels for containers for chemical products

             (1)  A person may apply to the APVMA for approval of a prescribed label for containers for a chemical product.

Note:          For prescribed label for containers for a chemical product, see subsection (4).

             (2)  The application must meet the application requirements.

Note:          For meets the application requirements, see section 8A.

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

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

                     (a)  for containers for a chemical product; and

                     (b)  that is of a kind:

                              (i)  prescribed by the regulations for the purposes of this subparagraph; or

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

             (5)  The APVMA must not determine a kind of label under subsection (6) unless it is satisfied that the kind of label would:

                     (a)  meet the labelling criteria; or

                     (b)  comply with the established standard for the chemical product.

             (6)  The APVMA may, by legislative instrument, determine a kind of label for the purposes of subparagraph (4)(b)(ii).

             (7)  Without limiting subsection (6), a kind of label may be described by reference to a kind of chemical product.

Decision on application

             (8)  The APVMA must approve the label that is the subject of the application if it is satisfied that:

                     (a)  the application meets the application requirements; and

                     (b)  the label that is the subject of the application is a prescribed label for containers for a chemical product; and

                     (c)  none of the circumstances determined in an instrument under subsection (10) apply in relation to the applicant.

Note:          For notice of approval, see section 8F.

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

Note:          For notice of refusal, see section 8G.

Disqualifying circumstances

           (10)  The APVMA may, by legislative instrument, determine circumstances for the purposes of paragraph (8)(c).

Subdivision DCommon provisions

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

After “section 14”, insert “or 14C”.

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

Insert:

       (1AA)  The APVMA must not use the following information to assess or make a decision on an application made under section 14C, 14D or 14E:

                     (a)  information given to the APVMA in connection with an application made under section 10 or 27 by the applicant for that application;

                     (b)  information given under section 161.

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

After “subsections (1)”, insert “, (1AA)”.

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

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

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

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

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

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

Part 2Information to be taken into account in determining applications

Agricultural and Veterinary Chemicals Code Act 1994

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

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

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

Insert:

          (2A)  Subsection (2) does not apply to information that is prescribed by the regulations, and that is provided in the circumstances prescribed by the regulations, for the purposes of this subsection.

14  Application provision

The amendments of section 8C of the Code set out in the Schedule to the Agricultural and Veterinary Chemicals Code Act 1994 made by this Part apply in relation to the following:

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

                     (b)  applications lodged before the commencement of this item but not determined by the APVMA before that commencement.

Part 3Limits on use of information

Agricultural and Veterinary Chemicals Code Act 1994

15  Section 3 of the Code set out in the Schedule (at the end of the definition of limitation period)

Add:

Note:          See also section 34MA (which deals with extensions of limitation periods).

16  Section 3 of the Code set out in the Schedule (paragraph (b) of the definition of protected active constituent)

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

17  Section 3 of the Code set out in the Schedule (paragraph (b) of the definition of protected chemical product)

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

18  Section 3 of the Code set out in the Schedule (at the end of the definition of protection period)

Add:

Note:          See also section 34KA (which deals with extensions of the protection period).

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

After “34K”, insert “, 34KA”.

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

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

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

Repeal the subsection, substitute:

Protected information whose protection period has expired

          (5A)  Another condition is that the information is protected information and either:

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

                     (b)  if the protection period in relation to that information is extended in accordance with regulations made for the purposes of section 34KA—the protection period, as extended, has ended.

Note:          For protected information and protection period, see section 3 and Part 3.

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

Insert:

34KA  Extension of protection periods

             (1)  The regulations may make provision for and in relation to either or both of the following:

                     (a)  extending the protection period in relation to protected information;

                     (b)  ending such an extension.

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

             (3)  Instead, an extension of a protection period must not occur unless, at least 3 years before that protection period (including that period as previously extended) will end, an application that satisfies the following is lodged:

                     (a)  the application is under a provision of this Part prescribed by the regulations for the purposes of this paragraph;

                     (b)  the application satisfies the requirements prescribed by the regulations for the purposes of this paragraph.

Maximum extension

             (4)  The total length of all extensions of a protection period, in relation to particular protected information, must not be more than 5 years.

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

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

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

Add:

Note:          Section 34MA deals with extensions of the limitation period.

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

Add:

34MA  Extension of limitation periods

             (1)  The regulations may make provision for and in relation to either or both of the following:

                     (a)  extending the limitation period for information covered by an item of the table in subsection 34M(1);

                     (b)  ending such an extension.

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

             (3)  Instead, an extension of a limitation period must not occur unless, at least 3 years before that limitation period (including that period as previously extended) will end, an application that satisfies the following is lodged:

                     (a)  the application is under a provision of this Part prescribed by the regulations for the purposes of this paragraph;

                     (b)  the application satisfies the requirements prescribed by the regulations for the purposes of this paragraph.

Maximum extension

             (4)  The total length of all extensions of a limitation period, for particular information covered by an item of the table in subsection 34M(1), must not be more than 5 years.

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

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

27  Application provisions

(1)       Section 34KA of the Code set out in the Schedule to the Agricultural and Veterinary Chemicals Code Act 1994, as inserted by this Part, applies in relation to a protection period beginning before, on or after the day this item commences.

(2)       Section 34MA of the Code set out in the Schedule to the Agricultural and Veterinary Chemicals Code Act 1994, as added by this Part, applies in relation to a limitation period beginning before, on or after the day this item commences.

Part 4Computerised decision‑making

Agricultural and Veterinary Chemicals Code Act 1994

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

Insert:

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

             (1)  The APVMA may arrange for the use, under the APVMA’s control, of computer programs for any purposes for which the APVMA may, or must, under this Code:

                     (a)  make a decision; or

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

                     (c)  do anything else related to making a decision to which paragraph (a) applies or related to exercising a power, or complying with an obligation, to which paragraph (b) applies.

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

                     (a)  made a decision; or

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

                     (c)  done something else related to the making of a decision or the exercise of a power or the compliance with an obligation;

that was made, exercised, complied with or done by the operation of a computer program under an arrangement made under subsection (1).

Substituted decisions

             (3)  The APVMA may substitute a decision for a decision (the initial decision) the APVMA is taken, under paragraph (2)(a), to have made if the APVMA is satisfied that the initial decision is incorrect.

             (4)  However, the substituted decision may only be made before the end of the period of 60 days beginning on the day the initial decision is made.

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

Repeal the paragraph, substitute:

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

                              (i)  has been made under this Code on behalf of the APVMA by a member of the staff of the APVMA; or

                             (ii)  is taken, under paragraph 5F(2)(a), to have been made by the APVMA for the purposes of this Code; and

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

Omit “original decision”, substitute “reviewable decision”.

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

Repeal the paragraph, substitute:

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

                              (i)  has been made under this Code on behalf of the APVMA by a member of the staff of the APVMA; or

                             (ii)  is taken, under paragraph 5F(2)(a), to have been made by the APVMA for the purposes of this Code; and

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

Omit “original decision” (wherever occurring), substitute “reviewable decision”.

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

Insert:

          (1B)  This section also applies if:

                     (a)  the APVMA is taken, under paragraph 5F(2)(a), to have made a decision (the initial decision) for the purposes of this Code; and

                     (b)  under this section, a person may request the APVMA to reconsider the initial decision; and

                     (c)  the APVMA, under subsection 5F(3), substitutes a decision (the reviewable decision) for the initial decision.

34  Subsections 166(2) to (4A) and (5) to (7) of the Code set out in the Schedule

Omit “original decision” (wherever occurring), substitute “reviewable decision”.

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

Insert:

          (2B)  If:

                     (a)  the APVMA is taken, under paragraph 5F(2)(a), to have made a decision (the initial decision) for the purposes of this Code; and

                     (b)  under subsection (1) of this section, an application may be made to the Administrative Appeals Tribunal for review of the initial decision; and

                     (c)  the APVMA, under subsection 5F(3), substitutes a decision for the initial decision;

an application may be made to the Administrative Appeals Tribunal for review of the substituted decision.

36  Application and saving provisions

(1)       The amendments of section 166 of the Code set out in the Schedule to the Agricultural and Veterinary Chemicals Code Act 1994 made by this Part apply in relation to reviewable decisions made on or after the commencement of this item.

(2)       Section 166 of the Code set out in the Schedule to the Agricultural and Veterinary Chemicals Code Act 1994, as in force immediately before the commencement of this item, continues to apply on and after that commencement in relation to original decisions made before that commencement.

Part 5Accreditation of assessors

Agricultural and Veterinary Chemicals (Administration) Act 1992

37  Section 4

Insert:

accredited person means a person who is accredited in accordance with an instrument made under section 6G of the Code set out in the Schedule to the Agricultural and Veterinary Chemicals Code Act 1994.

38  Paragraph 69ES(3)(c)

After “inspector”, insert “or accredited person”.

Agricultural and Veterinary Chemicals Code Act 1994

39  Section 3 of the Code set out in the Schedule

Insert:

accredited person means a person who is accredited in accordance with an instrument made under section 6G.

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

Add “or an instrument made under section 6G”.

41  At the end of subsection 6C(1) of the Code set out in the Schedule

Add “or an instrument made under section 6G”.

42  At the end of subsection 6C(2) of the Code set out in the Schedule

Add “and an instrument made under section 6G”.

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

Insert:

6G  Accreditation of persons

             (1)  The APVMA may, by legislative instrument, prescribe matters relating to:

                     (a)  the accreditation of persons (whether or not Australian citizens or Australian residents) by the APVMA for the purposes of this Code; and

                     (b)  such persons performing roles prescribed in the instrument (which may include the assessing of information of a kind prescribed in the instrument).

             (2)  Examples of matters that the instrument may deal with are the following:

                     (a)  the making of applications for accreditation;

                     (b)  the criteria that are to be met by persons who seek to be accredited;

                     (c)  how accreditation is to be recognised (for example, by establishment of a register or the issue of a certificate of accreditation);

                     (d)  whether accreditation is for a specified period or continues until it is revoked;

                     (e)  if accreditation is for a specified period—the renewal of accreditation, including the making of applications for renewal;

                      (f)  the certificates, assessments or reports that accredited persons may or must provide and the circumstances in which those certificates, assessments or reports may or must be provided;

                     (g)  the making of standards by the APVMA to be complied with by accredited persons in providing those certificates, assessments or reports;

                     (h)  the standards and other obligations that persons must continue to meet to remain accredited;

                      (i)  the conditions of accreditation and the variation or revocation of those conditions;

                      (j)  the APVMA’s monitoring of compliance with conditions of accreditation or other requirements in the instrument;

                     (k)  the obligations of accredited persons in relation to the APVMA’s monitoring of such compliance;

                      (l)  the circumstances in which an accredited person may have the person’s accreditation varied, suspended or revoked;

                    (m)  the review of decisions to refuse, vary, suspend or revoke accreditation;

                     (n)  the process for handling complaints involving accredited persons;

                     (o)  who may deliver training to accredited persons;

                     (p)  auditing accredited persons.

Incorporation of other instruments

             (3)  Despite subsection 14(2) of the Legislation Act 2003, an instrument under subsection (1) of this section may make provision in relation to a matter by applying, adopting or incorporating, with or without modification, any matter contained in an instrument or other writing as in force or existing from time to time.

Offences and civil penalties

             (4)  The regulations may prescribe penalties of not more than 50 penalty units for offences against the regulations, or declare provisions of the regulations to be civil penalty provisions, for or in relation to:

                     (a)  an accredited person’s contravention of a condition of accreditation; or

                     (b)  an accredited person’s contravention of other requirements made of the person under an instrument under subsection (1).

44  Section 155 of the Code set out in the Schedule (heading)

Omit “under this Code”.

45  Subsections 155(1), (2) and (3) of the Code set out in the Schedule

After “this Code” (wherever occurring), insert “or an instrument made under section 6G”.

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

After “consultant to the APVMA,”, insert “an accredited person,”.

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

Add “or an instrument made under section 6G”.

Part 6Voluntary recalls

Agricultural and Veterinary Chemicals Code Act 1994

48  Section 100 of the Code set out in the Schedule

Before “This Part”, insert “(1)”.

49  At the end of section 100 of the Code set out in the Schedule

Add:

             (2)  This Part also provides for voluntary recalls of chemical products (see section 106).

50  Section 106 of the Code set out in the Schedule

Repeal the section, substitute:

106  Notification to APVMA of voluntary recalls

             (1)  This section applies if a person voluntarily takes action to recall a chemical product because it appears to the person that:

                     (a)  either or both of the following apply:

                              (i)  the chemical product may not meet the safety criteria, the trade criteria or the efficacy criteria;

                             (ii)  a label for containers for the chemical product may not meet the labelling criteria; or

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

             (2)  The person must, within 2 days after taking the action, give the APVMA a notice that:

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

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

             (3)  Subsection (2) does not apply in the circumstances prescribed by the regulations for the purposes of this subsection.

Offence

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

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

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

Penalty:  60 penalty units.

Civil penalty

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

Note:          Division 2 of Part 9A provides for pecuniary penalties for contraventions of civil penalty provisions.

APVMA to publish notice of recall

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

                     (a)  must, within 3 working days, publish a copy of the notice on its website; and

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

The APVMA may also make available a copy of the notice in any other manner that it thinks appropriate.

             (7)  Subsection (6) does not apply in the circumstances prescribed by the regulations for the purposes of this subsection.

No limit on Competition and Consumer Act 2010

             (8)  This section does not limit section 128 of Schedule 2 to the Competition and Consumer Act 2010 (about voluntary recall of consumer goods).

51  Application provision

Section 106 of the Code set out in the Schedule to the Agricultural and Veterinary Chemicals Code Act 1994, as substituted by this Part, applies in relation to action taken on or after the commencement of this item.

Part 7Notification of new information

Agricultural and Veterinary Chemicals Code Act 1994

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

Omit “and”, substitute “or”.

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

Add:

                            (vi)  approval of a label for containers for a chemical product; or

                           (vii)  variation of the relevant particulars or conditions of the approval of an active constituent, of the registration of a chemical product or of the approval of a label for containers for a chemical product; and

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

Omit “or in relation to the product or any of its constituents”, substitute “in relation to the product or any of its constituents or in relation to the label”.

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

After “or 20(1)(c)”, insert “or relates to the matters covered by subparagraph 21(c)(iv) or (iva)”.

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

Add “or that the label may not meet the labelling criteria”.

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

Insert:

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

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

Omit “or in relation to the product or of any of its constituents”, substitute “, in relation to the product or of any of its constituents or in relation to the label”.

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

Omit “relevant information”, substitute “relevant information”.

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

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

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

Add “or that the label may not meet the labelling criteria”.

62  Application provisions

(1)       The amendments of section 160A of the Code set out in the Schedule to the Agricultural and Veterinary Chemicals Code Act 1994 made by this Part apply in relation to applications lodged on or after the commencement of this item.

(2)       The amendments of section 161 of the Code set out in the Schedule to the Agricultural and Veterinary Chemicals Code Act 1994 made by this Part apply in relation to information a holder becomes aware of on or after the commencement of this item (whether the approval of the label was given before, on or after that commencement).

Part 8Definition of registered chemical product

Agricultural and Veterinary Chemicals Code Act 1994

63  Section 3 of the Code set out in the Schedule (definition of registered chemical product)

Repeal the definition, substitute:

registered chemical product has the meaning given by section 5AA.

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

Insert:

5AA  Definition of registered chemical product

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

                     (a)  that is registered; and

                     (b)  that complies with the relevant particulars entered in the Register for the product.

Constituents of the chemical product

             (2)  If:

                     (a)  a chemical product is registered; and

                     (b)  under regulations made for the purposes of paragraph 20(1)(c), a relevant particular (the subject particular) required to be entered in the Register in relation to the chemical product is the constituents of the chemical product; and

                     (c)  there are regulations in force for the purposes of paragraph 83(1)(a) in relation to the chemical product; and

                     (d)  the constituents of the chemical product do not differ by more than the extent prescribed for the purposes of paragraph 83(1)(a);

then, for the purposes of paragraph (1)(b) of this section, the chemical product is taken to comply with the subject particular.

Concentration of constituents of the chemical product

             (3)  If:

                     (a)  a chemical product is registered; and

                     (b)  under regulations made for the purposes of paragraph 20(1)(c), a relevant particular (the subject particular) required to be entered in the Register in relation to the chemical product is the concentration of one or more constituents of the chemical product; and

                     (c)  there are regulations in force for the purposes of paragraph 83(1)(b) in relation to the chemical product; and

                     (d)  the concentration of the constituents of the chemical product does not differ by more than the extent prescribed for the purposes of paragraph 83(1)(b);

then, for the purposes of paragraph (1)(b) of this section, the chemical product is taken to comply with the subject particular.

Composition of constituents of the chemical product

             (4)  If:

                     (a)  a chemical product is registered; and

                     (b)  under regulations made for the purposes of paragraph 20(1)(c), a relevant particular (the subject particular) required to be entered in the Register in relation to the chemical product is the composition of a constituent of the chemical product; and

                     (c)  there are regulations in force for the purposes of paragraph 83(1)(c) in relation to the composition of that constituent of the chemical product; and

                     (d)  the composition of that constituent of the chemical product does not differ by more than the extent prescribed for the purposes of paragraph 83(1)(c);

then, for the purposes of paragraph (1)(b) of this section, the chemical product is taken to comply with the subject particular.

Purity of constituents of the chemical product

             (5)  If:

                     (a)  a chemical product is registered; and

                     (b)  under regulations made for the purposes of paragraph 20(1)(c), a relevant particular (the subject particular) required to be entered in the Register in relation to the chemical product is the purity of a constituent of the chemical product; and

                     (c)  there are regulations in force for the purposes of paragraph 83(1)(c) in relation to the purity of that constituent of the chemical product; and

                     (d)  the purity of that constituent of the chemical product does not differ by more than the extent prescribed for the purposes of paragraph 83(1)(c);

then, for the purposes of paragraph (1)(b) of this section, the chemical product is taken to comply with the subject particular.

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

Agricultural and Veterinary Chemicals Code Act 1994

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

Omit “the holder”, substitute “a person”.

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

Repeal the section, substitute:

38A  Suspension or cancellation of approval or registration for provision of false or misleading information

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

                     (a)  a person has given information:

                              (i)  in, or in connection with, the application for the approval or registration; or

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

                            (iii)  in response to a notice under subsection 32(1) or section 33 or 159; or

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

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

67  Application provision

Section 38A of the Code set out in the Schedule to the Agricultural and Veterinary Chemicals Code Act 1994, as substituted by this Part, applies in relation to information given on or after the commencement of this item.

Part 10Supply of registered chemical products with unapproved label

Agricultural and Veterinary Chemicals Code Act 1994

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

Omit “relevant particulars”, substitute “minimum information (see subsection (5))”.

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

Omit “the relevant particulars”, substitute “the minimum information”.

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

Omit “relevant particulars”, substitute “minimum information (see subsection (5))”.

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

Omit “the relevant particulars”, substitute “the minimum information”.

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

Repeal the paragraphs, substitute:

                     (a)  the label attached to the container states the minimum information (the earlier information) that was required to be stated on a label for containers for the product at a time before the supply takes place; and

                     (b)  the earlier information is different from the minimum information that is required to be stated on a label for containers for the product at the time the supply takes place; and

                     (c)  the APVMA has determined that this subsection applies in respect of the earlier information; and

                     (d)  the supply takes place not later than 2 years (or such shorter or longer period as the APVMA allows) after the earlier information ceased to be the minimum information that was required be stated on a label for containers for the product.

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

Add:

             (5)  For the purposes of this section, the minimum information is the information covered by subparagraphs 21(c)(iii) and (iv) (including that information as varied under Part 2).

74  Application provision

The amendments of section 81 of the Code set out in the Schedule to the Agricultural and Veterinary Chemicals Code Act 1994 made by this Part apply in relation to supplies occurring on or after the commencement of this item.

Part 11Variation of approval or registration during suspension

Agricultural and Veterinary Chemicals Code Act 1994

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

Repeal the heading, substitute:

42  Suspension or cancellation of approval or registration at request of holder

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

After “to”, insert “suspend or”.

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

Omit “the APVMA must cancel the approval or registration”, substitute “the APVMA must suspend or cancel the approval or registration (as the case may be)”.

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

Omit “A suspension under section 36 or subsection 41(2) or 44(2) of the approval of a label for containers for a chemical product”, substitute “A suspension of an approval or registration”.

79  Paragraphs 43(4)(a), (b) and (c) of the Code set out in the Schedule

After “approval”, insert “or registration”.

80  At the end of paragraph 43(4)(d) of the Code set out in the Schedule

Add “or registration”.

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

Add “or registration”.

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

After “notice of the”, insert “suspension or”.

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

After “requested the”, insert “suspension or”.

84  Application provisions

(1)       The amendments of section 42 of the Code set out in the Schedule to the Agricultural and Veterinary Chemicals Code Act 1994 made by this Part apply in relation to requests made on or after the commencement of this item.

(2)       The amendments of section 43 of the Code set out in the Schedule to the Agricultural and Veterinary Chemicals Code Act 1994 made by this Part apply in relation to:

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

                     (b)  a suspension made before the commencement of this item that was in effect immediately before that commencement.

Part 12Safety, efficacy, trade and labelling criteria

Agricultural and Veterinary Chemicals Code Act 1994

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

Add:

                   ; (d)  any matters prescribed by the regulations.

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

Insert:

5E  Overseas trials and experiments

                   Without limiting subparagraph 5A(2)(a)(vii) or (3)(a)(vii) or paragraph 5B(2)(d), 5C(2)(c) or 5D(2)(d) and despite section 160, the matters prescribed by regulations made for the purposes of that subparagraph or paragraph may relate to matters covered by paragraph 160(2)(a), (b) or (c).

87  Application provision

The amendment of section 5D of the Code set out in the Schedule to the Agricultural and Veterinary Chemicals Code Act 1994 made by this Part applies in relation to deciding, on or after the commencement of this item, whether a label for containers for a chemical product meets the labelling criteria.

Part 13Annual operational plans

Agricultural and Veterinary Chemicals (Administration) Act 1992

88  Part 6 (heading)

Repeal the heading, substitute:

Part 6Corporate plan

89  Sections 55, 56 and 57

Repeal the sections.

90  Paragraph 61(a)

Repeal the paragraph.

91  Paragraph 61(b)

Repeal the paragraph, substitute:

                     (b)  an evaluation of the APVMA’s overall performance during that period against the performance indicators (if any) prescribed by the regulations for the purposes of this paragraph; and

92  Paragraph 61(d)

Repeal the paragraph.

93  Application and transitional provisions

(1)       The amendments made by this Part apply in relation to the calendar year beginning on 1 January 2020 and each later calendar year.

(2)       Despite the amendments made by this Part, sections 55 to 57 of the Agricultural and Veterinary Chemicals (Administration) Act 1992, as in force immediately before the commencement of this item, continue to apply on and after that commencement in relation to an annual operational plan relating to the period of 12 months beginning on 1 July 2019.

(3)       Despite the amendments made by this Part, section 61 of the Agricultural and Veterinary Chemicals (Administration) Act 1992, as in force immediately before the commencement of this item, continues to apply on and after that commencement in relation to the period of 12 months beginning on 1 July 2019.

(4)       Regulations in force for the purposes of subparagraph 61(b)(ii) of the Agricultural and Veterinary Chemicals (Administration) Act 1992 immediately before the commencement of this item continue in force, on and after that commencement, for the purposes of paragraph 61(b) of that Act.

Part 14Other amendments

Agricultural and Veterinary Chemicals (Administration) Act 1992

94  Paragraph 7(1A)(a)

Omit “sale”, substitute “supply”.

95  Paragraphs 8A(2)(a) and (b)

Omit “whether to grant”.

96  Subsection 58(7)

Repeal the subsection.

97  Subsection 69D(1)

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

98  After subsection 69D(1A)

Insert:

       (1AA)  The APVMA may, on its own initiative, reconsider a decision of the APVMA to refuse to give a certificate under subsection (1).

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

                     (a)  confirm the decision; or

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

       (1AC)  The APVMA must give notice of a thing done under subsection (1AB) to the person who applied for the certificate.

99  Subsection 72(5)

Repeal the subsection, substitute:

             (5)  The Minister must cause a copy of the report of the review to be tabled in each House of the Parliament within 15 sitting days of that House after the Minister receives the report.

100  Sections 78, 79 and 80

Repeal the sections.

101  Application provision

Subsections 69D(1AA) to (1AC) of the Agricultural and Veterinary Chemicals (Administration) Act 1992, as inserted by this Part, apply in relation to decisions made on or after the commencement of this item.

Agricultural and Veterinary Chemicals Code Act 1994

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

Insert:

6F  Specification by class

                   To avoid doubt, a reference in this Code to a class or kind of matter or thing does not, by implication, affect the application of:

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

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

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

Omit “United States Pharmacopoeia”, substitute “United States Pharmacopeia”.

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

Omit “permit; or”, substitute “permit.”.

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

Repeal the paragraph.

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

Repeal the subsection.

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

Omit “(d)”, substitute “(c)”.

108  Subsection 74(3A) of the Code set out in the Schedule (note 2)

Omit “(d)”, substitute “(c)”.

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

Repeal the subsection.

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

Omit “section; or”, substitute “section.”.

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

Repeal the paragraph.

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

Repeal the subsection.

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

Omit “to (c)”, substitute “and (b)”.

114  Subsection 75(3A) of the Code set out in the Schedule (note 2)

Omit “to (c)”, substitute “and (b)”.

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

Repeal the subsection.

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

Omit “permit; or”, substitute “permit.”.

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

Repeal the paragraph.

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

Repeal the subsection.

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

Omit “to (c)”, substitute “and (b)”.

120  Subsection 76(3A) of the Code set out in the Schedule (note 2)

Omit “to (c)”, substitute “and (b)”.

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

Repeal the subsection.

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

Omit “section; or”, substitute “section.”.

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

Repeal the paragraph.

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

Repeal the subsection.

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

Omit “to (c)”, substitute “and (b)”.

126  Subsection 78(3A) of the Code set out in the Schedule (note 2)

Omit “to (c)”, substitute “and (b)”.

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

Repeal the subsection.

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

Repeal the subsections, substitute:

             (3)  If a request is so made, the APVMA must reconsider the original decision having regard only to the information used to make it.

             (4)  The APVMA may, on its own initiative, reconsider the original decision having regard only to the information used to make it.

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

                     (a)  confirm the original decision; or

                     (b)  vary the original decision; or

                     (c)  set aside the original decision; or

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

          (4B)  The APVMA must, as soon as practicable, give written notice setting out the APVMA’s decision on the reconsideration to:

                     (a)  for a reconsideration under subsection (3)—the person who made the request; or

                     (b)  for a reconsideration under subsection (4)—each person whose interests are affected by that decision of whom the APVMA is aware.

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

Omit “If the APVMA has not given notice under subsection (4)”, substitute “For a reconsideration under subsection (3), if the APVMA has not given notice under subsection (4B)”.

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

Repeal the paragraph.

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

Repeal the sections.

132  Application provision

The amendments of section 166 of the Code set out in the Schedule to the Agricultural and Veterinary Chemicals Code Act 1994 made by this Part apply in relation to original decisions made on or after the commencement of this item.

Agricultural and Veterinary Chemicals Legislation Amendment Act 2013

133  Subsection 4(4)

Omit “within 15 sitting days of that House after 1 July 2019”, substitute “before the end of the last day on which the report of the first review under section 72 of the Agricultural and Veterinary Chemicals (Administration) Act 1992 can be laid before that House”.

Schedule 2Other amendments

Part 1Amendments

Agricultural and Veterinary Chemicals Code Act 1994

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

Repeal the subparagraph, substitute:

                              (i)  the names, or proposed names, of the active constituents concerned; and

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

Omit “suspend or cancel the approval, or suspend or cancel the registration, as the case may be”, substitute “suspend or cancel the permit”.

3  Application provision

The repeal and substitution of subparagraph 8E(2)(b)(i) of the Code set out in the Schedule to the Agricultural and Veterinary Chemicals Code Act 1994 made by this Part applies in relation to notices given under section 8E of that Code on or after the commencement of this item.

Part 2Repeals

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

4  The whole of the Act

Repeal the Act.