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This is a Bill, not an Act. For current law, see the Acts databases.
2013-2014
The Parliament of the
Commonwealth of Australia
HOUSE OF REPRESENTATIVES
Presented and read a first time
Agricultural and Veterinary Chemicals
Legislation Amendment (Removing
Re-approval and Re-registration) Bill
2014
No. , 2014
(Agriculture)
A Bill for an Act to amend laws relating to
agricultural and veterinary chemicals, and for
other purposes
No. , 2014
Agricultural and Veterinary Chemicals Legislation Amendment
(Removing Re-approval and Re-registration) Bill 2014
i
Contents
1
Short title ........................................................................................... 1
2
Commencement ................................................................................. 1
3
Schedule(s) ........................................................................................ 2
Schedule 1--Removing re-approval and re-registration
3
Part 1--Amendments
3
Agricultural and Veterinary Chemical Products (Collection of Levy)
Act 1994
3
Agricultural and Veterinary Chemicals Code Act 1994
3
Agricultural and Veterinary Chemicals Legislation Amendment Act
2013
13
Part 2--Transitional provisions
14
Schedule 2--Miscellaneous amendments
15
Part 1--Amendments
15
Agricultural and Veterinary Chemicals Code Act 1994
15
Food Standards Australia New Zealand Act 1991
29
Part 2--Transitional provisions
31
No. , 2014
Agricultural and Veterinary Chemicals Legislation Amendment
(Removing Re-approval and Re-registration) Bill 2014
1
A Bill for an Act to amend laws relating to
1
agricultural and veterinary chemicals, and for
2
other purposes
3
The Parliament of Australia enacts:
4
1 Short title
5
This Act may be cited as the Agricultural and Veterinary
6
Chemicals Legislation Amendment (Removing Re-approval and
7
Re-registration) Act 2014.
8
2 Commencement
9
(1) Each provision of this Act specified in column 1 of the table
10
commences, or is taken to have commenced, in accordance with
11
2
Agricultural and Veterinary Chemicals Legislation Amendment
(Removing Re-approval and Re-registration) Bill 2014
No. , 2014
column 2 of the table. Any other statement in column 2 has effect
1
according to its terms.
2
3
Commencement information
Column 1
Column 2
Column 3
Provision(s)
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. Schedules 1
and 2
The later of:
(a) the start of the day this Act receives the
Royal Assent; and
(b) immediately after the commencement of
Schedule 1 to the Agricultural and
Veterinary Chemicals Legislation
Amendment Act 2013.
Note:
This table relates only to the provisions of this Act as originally
4
enacted. It will not be amended to deal with any later amendments of
5
this Act.
6
(2) Any information in column 3 of the table is not part of this Act.
7
Information may be inserted in this column, or information in it
8
may be edited, in any published version of this Act.
9
3 Schedule(s)
10
Each Act that is specified in a Schedule to this Act is amended or
11
repealed as set out in the applicable items in the Schedule
12
concerned, and any other item in a Schedule to this Act has effect
13
according to its terms.
14
Removing re-approval and re-registration Schedule 1
Amendments Part 1
No. , 2014
Agricultural and Veterinary Chemicals Legislation Amendment
(Removing Re-approval and Re-registration) Bill 2014
3
Schedule 1
--Removing re-approval and
1
re-registration
2
Part 1
--Amendments
3
Agricultural and Veterinary Chemical Products (Collection
4
of Levy) Act 1994
5
1 Subsection 36(1)
6
Omit "renewal of registration or re-registration", substitute "or the
7
renewal of registration,".
8
Agricultural and Veterinary Chemicals Code Act 1994
9
2 Section 3 of the Code set out in the Schedule
10
(paragraph (b) of the definition of approval)
11
Omit "product;", substitute "product.".
12
3 Section 3 of the Code set out in the Schedule (definition of
13
approval)
14
Omit all the words after paragraph (b).
15
4 Section 3 of the Code set out in the Schedule (definition of
16
determine)
17
Repeal the definition, substitute:
18
determine, in relation to an application, means:
19
(a) approve, register, renew, vary or issue upon the application;
20
or
21
(b) refuse the application.
22
5 Section 3 of the Code set out in the Schedule (definition of
23
listed chemical product)
24
Omit all the words after "means a chemical product", substitute:
25
that:
26
Schedule 1 Removing re-approval and re-registration
Part 1 Amendments
4
Agricultural and Veterinary Chemicals Legislation Amendment
(Removing Re-approval and Re-registration) Bill 2014
No. , 2014
(a) is, or is included in a class of chemical products that is, listed
1
by regulations under section 8T; and
2
(b) complies with the established standard for the product.
3
6 Section 3 of the Code set out in the Schedule (definition of
4
re-approval)
5
Repeal the definition.
6
7 Section 3 of the Code set out in the Schedule (definition of
7
registration)
8
Omit all the words after "chemical product".
9
8 Section 3 of the Code set out in the Schedule (definition of
10
relevant particulars)
11
Omit "29G,".
12
9 Section 3 of the Code set out in the Schedule (definition of
13
re-registration)
14
Repeal the definition.
15
10 Subsection 8B(2) of the Code set out in the Schedule
16
Repeal the subsection, substitute:
17
(2) The APVMA may specify information under subsection (1) only if
18
the inclusion of the information would enable the APVMA to
19
determine the application.
20
11 Subparagraph 8E(2)(c)(i) of the Code set out in the
21
Schedule
22
Omit ", other than an application under section 29D".
23
12 Subparagraph 8E(2)(c)(ii) of the Code set out in the
24
Schedule
25
Omit "29G,".
26
13 Paragraph 8F(1)(a) of the Code set out in the Schedule
27
Omit "(or re-approves)".
28
Removing re-approval and re-registration Schedule 1
Amendments Part 1
No. , 2014
Agricultural and Veterinary Chemicals Legislation Amendment
(Removing Re-approval and Re-registration) Bill 2014
5
14 Paragraph 8F(1)(b) of the Code set out in the Schedule
1
Omit "(or re-registers)".
2
15 Subparagraph 8F(2)(a)(iii) of the Code set out in the
3
Schedule
4
Repeal the subparagraph.
5
16 Paragraphs 8F(2)(b) and (c) of the Code set out in the
6
Schedule
7
Repeal the paragraphs, substitute:
8
(b) for a registration--state the date the registration ends; and
9
(c) for the renewal of a registration:
10
(i) state that the registration of the chemical product has
11
been renewed; and
12
(ii) state the date the registration (as renewed) ends; and
13
17 Subparagraphs 8F(2)(d)(iii) and (iv) of the Code set out in
14
the Schedule
15
Repeal the subparagraphs, substitute:
16
(iii) of a registration--state the date the registration ends;
17
and
18
18 Paragraph 8H(2)(c) of the Code set out in the Schedule
19
Repeal the paragraph.
20
19 Paragraph 8S(1)(b) of the Code set out in the Schedule
21
Omit "(or re-approves) or registers (or re-registers)", substitute "or
22
registers".
23
20 Subsection 9(5) of the Code set out in the Schedule
24
Repeal the subsection.
25
21 Paragraph 15(2)(b) of the Code set out in the Schedule
26
Omit all the words after "listed chemical product".
27
22 Subsection 19(1) of the Code set out in the Schedule
28
Omit "(1)".
29
Schedule 1 Removing re-approval and re-registration
Part 1 Amendments
6
Agricultural and Veterinary Chemicals Legislation Amendment
(Removing Re-approval and Re-registration) Bill 2014
No. , 2014
23 Paragraph 19(1)(d) of the Code set out in the Schedule
1
Omit "APVMA;", substitute "APVMA.".
2
24 Paragraph 19(1)(e) of the Code set out in the Schedule
3
Repeal the paragraph.
4
25 Subsections 19(2), (3) and (4) of the Code set out in the
5
Schedule
6
Repeal the subsections.
7
26 Paragraphs 20(1)(f) and (g) of the Code set out in the
8
Schedule
9
Repeal the paragraphs, substitute:
10
(f) the date the registration ends.
11
27 Subsections 20(2), (3) and (4) of the Code set out in the
12
Schedule
13
Repeal the subsections, substitute:
14
(2) The date the registration ends must:
15
(a) be the last day of a calendar month not more than 7 years
16
after the registration takes place; and
17
(b) be worked out in accordance with the method prescribed by
18
the regulations.
19
(3) However, if the regulations do not prescribe a method for the
20
purposes of paragraph (2)(b), the date the registration ends must be
21
the next 30 June after the registration takes place.
22
28 Subsections 26D(2) and (3) of the Code set out in the
23
Schedule
24
Repeal the subsections, substitute:
25
(2) If the relevant particulars of a listed chemical product are varied in
26
such a way that the product or any approved label for the product
27
does not comply with the established standard for the product, the
28
APVMA must amend the Register so that the product is no longer
29
noted as a listed chemical product.
30
Removing re-approval and re-registration Schedule 1
Amendments Part 1
No. , 2014
Agricultural and Veterinary Chemicals Legislation Amendment
(Removing Re-approval and Re-registration) Bill 2014
7
29 Subsections 29B(2) and (3) of the Code set out in the
1
Schedule
2
Repeal the subsections, substitute:
3
(2) If the relevant particulars or conditions of a listed chemical product
4
are varied in such a way that the product or any approved label for
5
the product does not comply with the established standard for the
6
product, the APVMA must amend the Register so that the product
7
is no longer noted as a listed chemical product.
8
30 Division 3A of Part 2 of the Code set out in the Schedule
9
Repeal the Division.
10
31 Subsection 29L(10) of the Code set out in the Schedule
11
Repeal the subsection, substitute:
12
(10) If the APVMA affirms the approval or registration, it must notify
13
the holder and publish a notice in the Gazette (section 34AC).
14
32 Subsections 34A(5) and (6) of the Code set out in the
15
Schedule
16
Repeal the subsections.
17
33 Paragraphs 34AC(2)(c), (d) and (e) of the Code set out in
18
the Schedule
19
Repeal the paragraphs, substitute:
20
(c) state the date the registration ends; and
21
(d) include any information prescribed by the regulations.
22
34 Sections 34AD and 34AE of the Code set out in the
23
Schedule
24
Repeal the sections.
25
35 Subsection 34AF(4) of the Code set out in the Schedule
26
Omit "34AE", substitute "34AC".
27
36 Subsection 34G(1A) of the Code set out in the Schedule
28
Omit ", 29A or 29G", substitute "or 29A".
29
Schedule 1 Removing re-approval and re-registration
Part 1 Amendments
8
Agricultural and Veterinary Chemicals Legislation Amendment
(Removing Re-approval and Re-registration) Bill 2014
No. , 2014
37 Subsection 43(2) of the Code set out in the Schedule
1
Omit "29D,".
2
38 Subsections 46A(3) to (6) of the Code set out in the
3
Schedule
4
Repeal the subsections, substitute:
5
(3) The APVMA must publish notice of the end of a registration as
6
soon as practicable after the registration has ended (section 47C).
7
(4) If the APVMA publishes notice of the end of the registration of a
8
product under section 47C, then:
9
(a) certain persons are taken to have a permit to possess, have
10
custody of or use of the product for a limited period
11
(section 47D); and
12
(b) persons may only supply the product in accordance with
13
instructions contained in the notice (section 47E).
14
39 Subsection 47(1) of the Code set out in the Schedule
15
Repeal the subsection, substitute:
16
(1) The approval of an active constituent continues in force unless it is
17
cancelled.
18
40 Subsection 47(3) of the Code set out in the Schedule
19
Repeal the subsection.
20
41 Subsection 47(6) of the Code set out in the Schedule
21
Repeal the subsection.
22
42 Section 47A of the Code set out in the Schedule
23
Repeal the section.
24
43 Subdivision C of Division 6 of Part 2 of the Code set out in
25
the Schedule (heading)
26
Repeal the heading, substitute:
27
Removing re-approval and re-registration Schedule 1
Amendments Part 1
No. , 2014
Agricultural and Veterinary Chemicals Legislation Amendment
(Removing Re-approval and Re-registration) Bill 2014
9
Subdivision C--Notifying the end of registrations
1
44 Section 47B of the Code set out in the Schedule
2
Repeal the section.
3
45 Section 47C of the Code set out in the Schedule (heading)
4
Repeal the heading, substitute:
5
47C Notice of end of registration
6
46 Subsection 47C(1) of the Code set out in the Schedule
7
Repeal the subsection, substitute:
8
(1) If the registration of a chemical product ends without being
9
renewed, the APVMA must publish in the Gazette, and in any
10
other manner that it thinks appropriate, notice of the end of the
11
registration.
12
47 Paragraphs 47C(2)(a), (b) and (c) of the Code set out in the
13
Schedule
14
Omit "approval or".
15
48 Paragraphs 47C(2)(d), (e) and (f) of the Code set out in the
16
Schedule
17
Omit "constituent or" (wherever occurring).
18
49 Subsection 47C(3) of the Code set out in the Schedule
19
Omit all the words after "not apply", substitute:
20
if:
21
(a) the APVMA thinks that, in the circumstances, it is
22
unnecessary to publish the notice; or
23
(b) the registration of the chemical product ends because it is
24
cancelled.
25
Note:
For notice of the cancellation of the registration of a chemical product,
26
see section 45A.
27
Schedule 1 Removing re-approval and re-registration
Part 1 Amendments
10
Agricultural and Veterinary Chemicals Legislation Amendment
(Removing Re-approval and Re-registration) Bill 2014
No. , 2014
50 Paragraph 47C(4)(a) of the Code set out in the Schedule
1
Omit "the holder", substitute "the person who was the holder of the
2
registration".
3
51 Paragraph 47C(4)(b) of the Code set out in the Schedule
4
Omit "approval or".
5
52 Section 47D of the Code set out in the Schedule
6
Repeal the section, substitute:
7
47D Permit taken to have been issued
8
(1) This section applies if notice of the end of the registration of a
9
chemical product is published under section 47C.
10
(2) A person who possesses, has custody of or uses the product in
11
accordance with the instructions contained in the notice is taken to
12
have been issued with a permit to do so until:
13
(a) 1 year after the day on which the registration ended; or
14
(b) the APVMA, by notice published in the Gazette, declares that
15
this subsection ceases to apply in respect of the product;
16
whichever first occurs.
17
(3) A permit that is taken to have been issued to a person under
18
subsection (1) does not authorise the person to manufacture or
19
import the product.
20
53 Subsection 47E(1) of the Code set out in the Schedule
21
Repeal the subsection, substitute:
22
(1) This section applies if, after notice of the end of the registration of
23
a chemical product is published under section 47C, a person has
24
possession or custody of the product with the intention of
25
supplying it.
26
54 Subsection 47E(2) of the Code set out in the Schedule
27
Omit "constituent or".
28
Removing re-approval and re-registration Schedule 1
Amendments Part 1
No. , 2014
Agricultural and Veterinary Chemicals Legislation Amendment
(Removing Re-approval and Re-registration) Bill 2014
11
55 Subsection 47E(3) of the Code set out in the Schedule
1
Omit "constituent or product was approved or", substitute "product
2
was".
3
56 Subsection 47E(3) of the Code set out in the Schedule
4
Omit "been approved or", substitute "been".
5
57 Subsection 47E(3) of the Code set out in the Schedule
6
Omit "approval or".
7
58 Subsection 48(2) of the Code set out in the Schedule
8
Repeal the subsection, substitute:
9
(2) Subject to subsection (3), the application must not be made:
10
(a) earlier than 3 months before the registration ends; or
11
(b) later than one month (or such shorter period as the APVMA
12
allows) before the registration ends.
13
59 Subsection 48(4) of the Code set out in the Schedule
14
Repeal the subsection.
15
60 Subsection 48(5) of the Code set out in the Schedule
16
Omit "renewal".
17
61 Subsection 49(1) of the Code set out in the Schedule
18
Repeal the subsection (not including the note), substitute:
19
(1) If the APVMA is satisfied that an application for the renewal of a
20
registration meets the application requirements, the APVMA must
21
renew the registration.
22
62 Section 50 of the Code set out in the Schedule
23
Before "Renewal", insert "(1)".
24
63 Section 50 of the Code set out in the Schedule
25
Omit all the words after "registration (as renewed)", substitute "ends".
26
Schedule 1 Removing re-approval and re-registration
Part 1 Amendments
12
Agricultural and Veterinary Chemicals Legislation Amendment
(Removing Re-approval and Re-registration) Bill 2014
No. , 2014
64 At the end of section 50 of the Code set out in the
1
Schedule
2
Add:
3
(2) The date the registration (as renewed) ends must:
4
(a) be the last day of a calendar month not less than 12 months
5
and not more than 7 years after the renewal takes place; and
6
(b) be worked out in accordance with the method prescribed by
7
the regulations.
8
(3) However, if the regulations do not prescribe a method for the
9
purposes of paragraph (2)(b), the date the registration (as renewed)
10
ends must be the next 30 June after the renewal takes place.
11
65 Subsection 59(1) of the Code set out in the Schedule
12
(note)
13
Repeal the note.
14
66 Paragraph 59(2)(e) of the Code set out in the Schedule
15
Omit all the words after "information and", substitute "Division 4A of
16
Part 2 does not limit the use of the information; or".
17
67 Paragraph 59(6)(a) of the Code set out in the Schedule
18
Omit ", other than under Division 3A of Part 2 (re-approving and
19
re-registering)".
20
68 Paragraph 165(2)(a) of the Code set out in the Schedule
21
Repeal the paragraph.
22
69 Subparagraph 166(1A)(b)(i) of the Code set out in the
23
Schedule
24
Omit ", 29E(3)".
25
70 Paragraphs 167(1)(da) and (db) of the Code set out in the
26
Schedule
27
Repeal the paragraphs.
28
Removing re-approval and re-registration Schedule 1
Amendments Part 1
No. , 2014
Agricultural and Veterinary Chemicals Legislation Amendment
(Removing Re-approval and Re-registration) Bill 2014
13
Agricultural and Veterinary Chemicals Legislation
1
Amendment Act 2013
2
71 Item 51 of Schedule 6
3
Repeal the item.
4
Schedule 1 Removing re-approval and re-registration
Part 2 Transitional provisions
14
Agricultural and Veterinary Chemicals Legislation Amendment
(Removing Re-approval and Re-registration) Bill 2014
No. , 2014
Part 2
--Transitional provisions
1
72 End dates
2
(1)
This item applies if, before the commencement of this Schedule, the
3
APVMA has entered:
4
(a) the date an approval ends in the Record; or
5
(b) the date after which a registration cannot be renewed in the
6
Register.
7
(2)
The APVMA must remove the date.
8
Miscellaneous amendments Schedule 2
Amendments Part 1
No. , 2014
Agricultural and Veterinary Chemicals Legislation Amendment
(Removing Re-approval and Re-registration) Bill 2014
15
Schedule 2
--Miscellaneous amendments
1
Part 1
--Amendments
2
Agricultural and Veterinary Chemicals Code Act 1994
3
1 Section 3 of the Code set out in the Schedule
4
(paragraph (a) of the definition of agvet law)
5
After "Agvet Code", insert "or the Agvet Regulations".
6
2 Section 3 of the Code set out in the Schedule
7
(paragraph (a) of the definition of agvet penalty
8
provision)
9
After "Agvet Code", insert "or the Agvet Regulations".
10
3 Section 3 of the Code set out in the Schedule (definition of
11
approved active constituent)
12
Repeal the definition, substitute:
13
approved active constituent means an active constituent that is
14
approved and complies with the relevant particulars entered in the
15
Record for the constituent.
16
4 Section 3 of the Code set out in the Schedule (definition of
17
approved label)
18
Repeal the definition, substitute:
19
approved label means a label that is approved and complies with
20
the relevant particulars recorded in the relevant APVMA file for
21
the label.
22
5 Section 3 of the Code set out in the Schedule (definition of
23
continue)
24
After "continue,", insert "in relation to".
25
6 Section 3 of the Code set out in the Schedule (second
26
definition of limitation period)
27
Repeal the definition.
28
Schedule 2 Miscellaneous amendments
Part 1 Amendments
16
Agricultural and Veterinary Chemicals Legislation Amendment
(Removing Re-approval and Re-registration) Bill 2014
No. , 2014
7 Section 3 of the Code set out in the Schedule (definition of
1
lodged)
2
After "this Code", insert "or a notice under Division 2AA of Part 2".
3
8 Section 3 of the Code set out in the Schedule
4
Insert:
5
meets the notice requirements has the meaning given by
6
subsection 26AD(1).
7
9 Section 3 of the Code set out in the Schedule
8
Insert:
9
notifiable variation, of the relevant particulars of an approval or
10
registration, has the meaning given by subsection 26AB(3).
11
10 Section 3 of the Code set out in the Schedule
12
Insert:
13
prescribed variation, of the relevant particulars of an approval or
14
registration, has the meaning given by subsection 26B(4).
15
11 Section 3 of the Code set out in the Schedule (definition of
16
registered chemical product)
17
Repeal the definition, substitute:
18
registered chemical product means a chemical product that is
19
registered and complies with the relevant particulars entered in the
20
Register for the product.
21
12 Section 3 of the Code set out in the Schedule (definition of
22
relevant particulars)
23
After "26,", insert "26AC,".
24
13 Section 3 of the Code set out in the Schedule (first and
25
second definitions of secondary applicant)
26
Repeal the definitions.
27
Miscellaneous amendments Schedule 2
Amendments Part 1
No. , 2014
Agricultural and Veterinary Chemicals Legislation Amendment
(Removing Re-approval and Re-registration) Bill 2014
17
14 Section 6B of the Code set out in the Schedule
1
Repeal the section, substitute:
2
6B Varying relevant particulars and conditions
3
To avoid doubt, a power under this Code to vary relevant
4
particulars or conditions:
5
(a) includes the power to add or remove relevant particulars or
6
conditions; but
7
(b) does not authorise the APVMA to vary or remove relevant
8
particulars that were not determined, or conditions that were
9
not imposed, by the APVMA.
10
15 Subparagraph 8A(a)(v) of the Code set out in the Schedule
11
Repeal the subparagraph, substitute:
12
(v) contains, or is accompanied by, any information
13
specified for the application by the APVMA under
14
section 8B or prescribed for the application by the
15
regulations for the purposes of this subparagraph.
16
16 Paragraph 8A(e) of the Code set out in the Schedule
17
Omit "payable", substitute "due and payable".
18
17 Paragraph 8F(1)(e)
19
Omit "whether on application or on the initiative of the APVMA",
20
substitute "whether on notice under Division 2AA of Part 2, on
21
application or on the initiative of the APVMA".
22
18 At the end of subsection 8F(2) of the Code set out in the
23
Schedule
24
Add:
25
Note:
This subsection does not authorise the disclosure of confidential
26
commercial information whose disclosure would otherwise be
27
prohibited by section 162: see section 8X.
28
19 Section 8K of the Code set out in the Schedule
29
Repeal the section.
30
Schedule 2 Miscellaneous amendments
Part 1 Amendments
18
Agricultural and Veterinary Chemicals Legislation Amendment
(Removing Re-approval and Re-registration) Bill 2014
No. , 2014
20 Paragraph 8S(1)(b) of the Code set out in the Schedule
1
Omit "application; or", substitute "application.".
2
21 Paragraph 8S(1)(c) of the Code set out in the Schedule
3
Repeal the paragraph.
4
22 Paragraph 8S(2)(b) of the Code set out in the Schedule
5
Repeal the paragraph.
6
23 At the end of subsection 8S(2) of the Code set out in the
7
Schedule
8
Add:
9
Note:
This subsection does not authorise the disclosure of confidential
10
commercial information whose disclosure would otherwise be
11
prohibited by section 162: see section 8X.
12
24 At the end of Part 1 of the Code set out in the Schedule
13
Add:
14
Division 7--Access to certain documents and information
15
8W Access to certain documents in the possession or custody of the
16
APVMA
17
(1) A person may, in writing, apply to the APVMA for a copy of, or
18
extract from, a document (other than a document in any part of the
19
Record or Register) in the possession or custody of the APVMA in
20
relation to an approved active constituent or registered chemical
21
product.
22
(2) The APVMA must provide the copy or extract to the person if the
23
person pays the prescribed fee (if any).
24
Note 1:
See subsections 17(4) and (5) and 18(4) and (5) for access to the
25
Record and Register.
26
Note 2:
This subsection does not authorise the disclosure of confidential
27
commercial information whose disclosure would otherwise be
28
prohibited by section 162: see section 8X.
29
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19
8X Confidential commercial information must not be disclosed
1
under certain provisions
2
(1) Engaging in conduct in the performance of functions or duties, or
3
the exercise of powers, under any of the following provisions does
4
not authorise the disclosure of confidential commercial information
5
whose disclosure would otherwise be prohibited by section 162:
6
(a) subsection 8F(2);
7
(b) subsection 8S(2);
8
(c) subsection 8W(2);
9
(d) subsection 17(4) or (5);
10
(e) subsection 18(4) or (5);
11
(f) subsection 34AB(2);
12
(g) subsection 34AC(2).
13
(2) Subsection (1) has effect despite subsection 162(1A).
14
25 After subsection 9(2) of the Code set out in the Schedule
15
Insert:
16
(2A) Division 2AA provides for notifiable variations of relevant
17
particulars of approvals and registrations if the variations are of a
18
kind determined by the APVMA or prescribed by the regulations
19
and are not prescribed variations under Division 2A. Only holders
20
of approvals or registrations may notify variations under
21
Division 2AA.
22
26 Subsection 9(3) of the Code set out in the Schedule
23
Omit "if the relevant particulars are of a kind set out in a legislative
24
instrument made under section 26B", substitute "if the variations are of
25
a kind determined by the APVMA or prescribed by the regulations".
26
27 Subsections 17(4) and (5) and 18(4) and (5) of the Code set
27
out in the Schedule (note)
28
Omit "8K", substitute "8X".
29
28 Subsection 23(2) of the Code set out in the Schedule
30
Omit "remains", substitute "is taken to remain".
31
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29 Before Division 2A of Part 2 of the Code set out in the
1
Schedule
2
Insert:
3
Division 2AA--Notified variations of relevant particulars
4
26AA Explanation of Division
5
(1) This Division provides for some kinds of variations of relevant
6
particulars of approvals and registrations (called notifiable
7
variations) to be made on notice by the holders of approvals or
8
registrations.
9
(2) A notifiable variation is a variation of a kind:
10
(a) determined by the APVMA; or
11
(b) prescribed by the regulations.
12
A prescribed variation under Division 2A cannot be a notifiable
13
variation.
14
(3) Only holders of approvals or registrations may notify variations
15
under this Division (section 26AB). The notice must meet the
16
notice requirements specified in subsection 26AD(1).
17
(4) Section 26AC sets out how the APVMA varies the relevant
18
particulars on notice under this Division.
19
26AB Notice of notifiable variations
20
(1) The holder may, in writing, lodge notice with the APVMA of one
21
or more notifiable variations of the relevant particulars of an
22
approval or registration.
23
(2) The notice must meet the notice requirements.
24
Note:
For meets the notice requirements, see subsection 26AD(1).
25
(3) A notifiable variation is a variation of a kind that:
26
(a) either:
27
(i) is determined by the APVMA under subsection (5); or
28
(ii) is prescribed by the regulations; and
29
(b) is not a prescribed variation under Division 2A.
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(4) The APVMA must not determine a kind of variation under
1
subsection (5) unless it is satisfied that, with the relevant
2
particulars so varied:
3
(a) for an active constituent--the constituent would meet the
4
safety criteria; and
5
(b) for a chemical product--the product would:
6
(i) meet the safety criteria, the trade criteria and the
7
efficacy criteria; or
8
(ii) comply with the established standard for the product;
9
and
10
(c) for a label for a chemical product--the label would:
11
(i) meet the labelling criteria; or
12
(ii) comply with the established standard for the product.
13
(5) The APVMA may, by legislative instrument, determine a kind of
14
variation for the purposes of subparagraph (3)(a)(i).
15
(6) If the notice does not meet the notice requirements, the APVMA
16
must:
17
(a) notify the holder in writing of that fact; and
18
(b) include in the notice the reasons why the holder's notice
19
does not meet the notice requirements.
20
26AC Variation of relevant particulars
21
(1) If a notice is lodged under section 26AB, the APVMA must vary
22
the relevant particulars of the approval or registration as proposed
23
in the notice.
24
(2) The variation is taken to have effect on the day the notice is
25
lodged.
26
(3) The APVMA must, within 14 days after the notice is lodged:
27
(a) record in the Record, Register or relevant APVMA file, as
28
required, the relevant particulars as varied and the day the
29
notice was lodged; and
30
(b) if the relevant particulars of a listed chemical product are
31
varied in such a way that the product or any approved label
32
for the product does not comply with the established standard
33
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for the product--amend the Register so that the product is no
1
longer noted as a listed chemical product.
2
Note 1:
For notice of variation, see section 8F.
3
Note 2:
For publication of the variation, see section 8J.
4
26AD Notice requirements
5
(1) For the purposes of this Division, a notice meets the notice
6
requirements if the notice:
7
(a) is in writing in the approved form; and
8
(b) is signed by the holder of the approval or registration to
9
which the notice relates; and
10
(c) is accompanied by the prescribed fee; and
11
(d) is lodged with the APVMA; and
12
(e) contains, or is accompanied by, any information:
13
(i) specified by the APVMA under subsection (2); or
14
(ii) prescribed by the regulations.
15
(2) For the purposes of subparagraph (1)(e)(i), the APVMA may, by
16
legislative instrument, specify the information that must be
17
contained in, or accompany, the notice.
18
(3) The APVMA may specify information under subsection (2) only if
19
the information is relevant to a notifiable variation.
20
30 Division 2A of Part 2 of the Code set out in the Schedule
21
(heading)
22
Repeal the heading, substitute:
23
Division 2A--Prescribed variations of relevant particulars
24
31 Sections 26A to 26C of the Code set out in the Schedule
25
Repeal the sections, substitute:
26
26A Explanation of Division
27
(1) This Division provides for prescribed variations of relevant
28
particulars of approvals and registrations.
29
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(2) A prescribed variation is a variation of a kind:
1
(a) determined by the APVMA; or
2
(b) prescribed by the regulations.
3
(3) Only holders of approvals or registrations may apply under this
4
Division (section 26B). The application must meet the application
5
requirements specified in section 8A.
6
(4) Section 26D sets out how a variation takes place.
7
26B Applications for prescribed variations
8
(1) The holder may apply to the APVMA for one or more prescribed
9
variations of the relevant particulars of an approval or registration.
10
(2) The application must meet the application requirements.
11
Note:
For meets the application requirements, see section 8A.
12
(3) The APVMA may alter the application with the written consent of
13
the applicant.
14
(4) A prescribed variation is a variation of a kind:
15
(a) determined by the APVMA under subsection (6); or
16
(b) prescribed by the regulations.
17
(5) The APVMA must not determine a kind of variation under
18
subsection (6) unless it is satisfied that, with the relevant
19
particulars so varied:
20
(a) for an active constituent--the constituent would meet the
21
safety criteria; and
22
(b) for a chemical product--the product would:
23
(i) meet the safety criteria, the trade criteria and the
24
efficacy criteria; or
25
(ii) comply with the established standard for the product;
26
and
27
(c) for a label for a chemical product--the label would:
28
(i) meet the labelling criteria; or
29
(ii) comply with the established standard for the product.
30
(6) The APVMA may, by legislative instrument, determine a kind of
31
variation for the purposes of paragraph (4)(a).
32
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(7) If the application does not meet the application requirements, the
1
APVMA must:
2
(a) notify the holder in writing of that fact; and
3
(b) include in the notice the reasons why the holder's
4
application does not meet the application requirements.
5
26C Decision on prescribed variations
6
(1) The APVMA must, within the period prescribed by the regulations:
7
(a) if it is satisfied that the application meets the application
8
requirements--vary the relevant particulars as proposed in
9
the application; or
10
(b) otherwise--refuse the application.
11
Note 1:
For notice of variation, see section 8F.
12
Note 2:
For notice of refusal, see section 8G.
13
(2) If the APVMA does not make a decision on the application within
14
the period prescribed, the APVMA is, immediately after the end of
15
that period, taken to have made a decision under subsection (1) to
16
vary the relevant particulars as proposed in the application.
17
32 Section 26D of the Code set out in the Schedule (heading)
18
Repeal the heading, substitute:
19
26D How prescribed variation takes place
20
33 Subsection 26D(1) of the Code set out in the Schedule
21
Repeal the subsection, substitute:
22
(1) Variation of relevant particulars under this Division takes place
23
when the APVMA records in the Record, Register or relevant
24
APVMA file, as required, the relevant particulars as varied and the
25
date on which the variation is made.
26
34 Subsection 27(4) of the Code set out in the Schedule
27
Repeal the subsection.
28
35 Subsection 32(1) of the Code set out in the Schedule
29
After "notice to the holder", insert "of the approval or registration".
30
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36 Subsection 33(1) of the Code set out in the Schedule
1
After "given to the holder", insert "of the approval or registration".
2
37 At the end of subsection 34AB(2) of the Code set out in
3
the Schedule
4
Add:
5
Note:
This subsection does not authorise the disclosure of confidential
6
commercial information whose disclosure would otherwise be
7
prohibited by section 162: see section 8X.
8
38 At the end of subsection 34AC(2) of the Code set out in
9
the Schedule
10
Add:
11
Note:
This subsection does not authorise the disclosure of confidential
12
commercial information whose disclosure would otherwise be
13
prohibited by section 162: see section 8X.
14
39 Subsection 59(6) of the Code set out in the Schedule
15
Omit "continue an approval or registration", insert "continue, in
16
relation to an approval or registration,".
17
40 Subsection 86(4) of the Code set out in the Schedule
18
Omit "Subsections (1) and (2)", substitute "Subsections (1A) and (2A)".
19
41 Section 89A of the Code set out in the Schedule
20
Omit all the words after "a chemical product", substitute ", or a product
21
included in a class of chemical products, prescribed by the regulations".
22
42 Section 99 of the Code set out in the Schedule (heading)
23
Repeal the heading, substitute:
24
99 Information and documents about, and analysis of, substances
25
supplied as active constituents or chemical products
26
43 Subsections 99(1) to (5) of the Code set out in the
27
Schedule
28
Repeal the subsections, substitute:
29
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(1) This section applies if the APVMA reasonably believes that it is
1
necessary to exercise powers under this section:
2
(a) to protect the health and safety of human beings; or
3
(b) to protect animals, plants or things, or the environment; or
4
(c) to prevent significant prejudice to trade or commerce
5
between Australia and places outside Australia.
6
(2) The APVMA may give written notice to a person who has, has had
7
or will have, possession or custody of a substance or mixture of
8
substances that is or was intended for supply by the person:
9
(a) as a chemical product; or
10
(b) as an active constituent for a proposed or existing chemical
11
product;
12
requiring the person to give the APVMA information or documents
13
specified in the notice or to take the steps specified in the notice.
14
(3) The notice may require the person to give to the APVMA, within
15
such reasonable period as is specified in the notice, information or
16
documents required by the notice about the following:
17
(a) the constituents of the substance or mixture;
18
(b) the concentration of the constituents of the substance or
19
mixture;
20
(c) the formulation type of the substance or mixture;
21
(d) the composition or purity of a constituent of the substance or
22
mixture;
23
(e) the name of each manufacturer of the substance or mixture;
24
(f) the address of each site at which the substance or mixture is
25
manufactured;
26
(g) the packaging or labelling of the substance or mixture;
27
(h) advertising material related to the substance or mixture;
28
(j) if the substance or mixture is intended to be supplied, or has
29
been supplied, as an active constituent for a chemical
30
product, or as a chemical product, under a particular name--
31
the name of the constituent or product and whether:
32
(i) the substance or mixture conforms to any standard
33
prescribed in respect of the constituent or product with
34
that name, any established standard or any other
35
prescribed requirement; or
36
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27
(ii) the supply of the substance or mixture is or was in
1
accordance with any conditions applying to the approval
2
or registration of the constituent or product with that
3
name;
4
(k) any other prescribed information or documents.
5
(4) The notice may also require the person, within such reasonable
6
period as is specified in the notice:
7
(a) to have the substance or mixture analysed to find out about
8
the matters mentioned in paragraphs (3)(a) to (d) and
9
paragraphs (3)(j) and (k); and
10
(b) to give the results of the analysis to the APVMA; and
11
(c) to give the analyst's certificate to the APVMA.
12
(4A) Without limiting subsection (4), the notice may require any one or
13
more of the following:
14
(a) that samples of the substance or mixture are taken:
15
(i) under the supervision of an inspector; or
16
(ii) in the manner stated in the notice;
17
(b) that the analysis is carried out:
18
(i) under the supervision of an approved analyst; or
19
(ii) in the manner stated in the notice;
20
(c) that the analysis is carried out at a prescribed laboratory;
21
(d) that the analysis is carried out within a period stated in the
22
notice;
23
(e) that the analysis is carried out at the expense of the person.
24
(4B) Information or results required to be given to the APVMA must be
25
given in writing.
26
Note:
For giving information electronically, see section 156A.
27
(5) A person to whom a notice is given under subsection (2) must not
28
fail to comply with the notice.
29
44 Subsection 116(3C) of the Code set out in the Schedule
30
(note)
31
Omit "provisions..", substitute "provisions.".
32
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45 Section 120A of the Code set out in the Schedule
1
Omit all the words after "apply to", substitute "a chemical product, or a
2
product included in a class of chemical products, prescribed by the
3
regulations".
4
46 Paragraph 121(4)(a) of the Code set out in the Schedule
5
Omit "the products are exempt products or".
6
47 After section 146 of the Code set out in the Schedule
7
Insert:
8
146A Self-incrimination to be a reasonable excuse for
9
non-compliance with requirement
10
It is a reasonable excuse for an individual to refuse or fail to give
11
information, produce a document or do any other thing that the
12
individual is required to do by or under this Code that the
13
information, the production of the document or the doing of that
14
other thing would tend to incriminate the individual.
15
48 At the end of subsection 159(1) of the Code set out in the
16
Schedule
17
Add:
18
; (h) conduct, or cause to be conducted, trials or laboratory
19
experiments and give the results of the trials or experiments
20
to the APVMA.
21
49 Subsection 164(1) of the Code set out in the Schedule
22
After "an application to the APVMA,", insert "the lodging of a notice
23
under Division 2AA of Part 2,".
24
50 Subsection 164(5) of the Code set out in the Schedule
25
After "an application to the APVMA,", insert "the lodging of a notice
26
under Division 2AA of Part 2,".
27
51 Subsection 164(5) of the Code set out in the Schedule
28
After "corresponding application,", insert "the lodging of a
29
corresponding notice,".
30
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52 After subsection 164(7) of the Code set out in the
1
Schedule
2
Insert:
3
(7A) If a fee has to be paid in respect of a notice under Division 2AA of
4
Part 2, the notice is taken not to have been lodged until the fee is
5
paid.
6
53 Subparagraph 166(1A)(b)(i) of the Code set out in the
7
Schedule
8
Omit "26C(2),", substitute "paragraph 26C(1)(b), subsection".
9
54 After subparagraph 166(1A)(b)(i)
10
Insert:
11
(ia) a decision under Division 2AA of Part 2 that a notice
12
does not meet the notice requirements; or
13
55 Paragraph 167(1)(j) of the Code set out in the Schedule
14
Repeal the paragraph, substitute:
15
(j) a decision under section 99 to issue a notice;
16
Food Standards Australia New Zealand Act 1991
17
56 Section 80
18
Omit "13A", substitute "8E".
19
57 Paragraph 81(1)(a)
20
Omit "13A", substitute "8E".
21
58 Paragraph 81(1)(b)
22
Omit "13A(2)(b)(i)", substitute "8E(2)(b)(i)".
23
59 Paragraph 81(1)(b)
24
Omit "section 13A", substitute "section 8E".
25
60 Subsection 81(2)
26
Omit "13A", substitute "8E".
27
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61 Subsection 84(1)
1
After "without amendments),", insert "or under section 53 and 79 that
2
the Authority has approved a draft high level health claims variation,".
3
62 Subsection 84(2)
4
After "variation,", insert "or a draft high level health claims variation,".
5
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Part 2
--Transitional provisions
1
63 Exempt products for the purposes of paragraph 121(4)(a)
2
of the Code
3
(1)
This item applies to the following as in force immediately before the
4
commencement of this Schedule:
5
(a) paragraph 121(4)(a) of the Code;
6
(b) any regulations made for the purposes of that paragraph.
7
(2)
Despite the amendments made by item 46 of this Schedule, that
8
paragraph and those regulations have effect after the commencement of
9
this Schedule until regulations are made for the purpose of section 120A
10
of the Code.
11
(3)
In this item:
12
the Code means the Schedule to the Agricultural and Veterinary
13
Chemicals Code Act 1994.
14