Agricultural Compounds and Veterinary Medicines Amendment Act 2007

1: Title
This Act is the Agricultural Compounds and Veterinary Medicines Amendment Act 2007.
2: Commencement
This Act comes into force on the day after the date on which it receives the Royal assent.
3: Principal Act amended
This Act amends the Agricultural Compounds and Veterinary Medicines Act 1997 2007-10-18 Agricultural Compounds and Veterinary Medicines Act 1997
1: Amendments to Parts 1 to 3 of principal Act
4: Interpretation
1: Section 2(1) accredited person
2: Section 2(1) ACVM officer section 60 .
3: Section 2(1) agricultural compound agricultural compound
a: any substance, mixture of substances, or biological compound, used or intended for use in the direct management of plants and animals, or to be applied to the land, place, or water on or in which the plants and animals are managed, for the purposes of—
i: managing or eradicating pests, including vertebrate pests; or
ii: maintaining, promoting, or regulating plant or animal productivity and performance or reproduction; or
iii: fulfilling nutritional requirements; or
iv: the manipulation, capture, or immobilisation of animals; or
v: diagnosing the condition of animals; or
vi: preventing or treating conditions of animals; or
vii: enhancing the effectiveness of an agricultural compound used for the treatment of plants and animals; or
viii: marking animals; and
b: includes—
i: any veterinary medicine, substance, mixture of substances, or biological compound used for post-harvest treatment of raw primary produce; and
ii: anything used or intended to be used as feed for animals; and
iii: any substance, mixture of substances, or biological compound declared to be an agricultural compound for the purposes of this Act by Order in Council made under subsection (2) .
4: Section 2(1)
a: by repealing the definition of authorised person
b: by omitting from the definition of authorised place inspector ACVM officer
c: by repealing the definition of code of practice
d: by omitting from the definition of Director-General of Agriculture
e: by repealing the definition of inspector
5: Section 2(1) Minister Ministry .
6: Section 2(1) new organism operating plan section 28(2) section 21(2) of the Agricultural Compounds and Veterinary Medicines Amendment Act 2007 section 28(2) .
7: Section 2(1) primary produce public health
a: the people of New Zealand; or
b: a community or section of such people recognised person section 62 .
5: Purpose of Act
Section 4(a) subparagraph (i)
ai: risks to public health; and .
6: New section 4A inserted
The following section is inserted after section 4
4A: Scheme of Act
1: This Act aims to achieve its purpose by providing that no agricultural compound may be used (including imported, manufactured, or sold) in New Zealand unless that use is authorised by or under this Act.
2: The 2 main mechanisms for authorising use of an agricultural compound are—
a: an assessment of the compound, and its registration for use subject to specifically imposed conditions:
b: an exemption from the requirement to register the compound, so long as any specified conditions for exemption are met.
3: A range of conditions may be imposed to manage the risks associated with agricultural compounds. These conditions may relate to substances, products, systems, or people's behaviour, and may be imposed—
a: directly by the Director-General when an agricultural compound is registered or exempted from the requirement to be registered; or
b: generally, by regulations.
4: The Director-General may also issue notices that set out the technical detail of how compliance with conditions imposed by regulations can be achieved.
5: This Act, by its subject-matter, has a relationship with other Acts such as the Animal Products Act 1999 Food Act 1981 Wine Act 2003 Animal Welfare Act 1999 Biosecurity Act 1993 Medicines Act 1981 Hazardous Substances and New Organisms Act 1986
a: maximum residue limits for food products are set under the Food Act 1981
b: this Act assesses and controls agricultural compounds to ensure the Food Act residue limit is not breached.
7: Imported agricultural compounds to be cleared for entry into New Zealand
Section 5 inspector paragraphs (a), (b), and (c) ACVM officer
8: Agricultural compound clearance
1: Section 6(1) section 7 sections 7 and 7A
2: Section 6(2) inspector ACVM officer
3: Section 6(3)(a) subparagraphs (iii) and (iv)
iii: the goods are an agricultural compound and are exempt from registration as a trade name product under section 8A .
9: Declaration
Section 7 statutory declaration declaring that a declaration in a manner determined by the Director-General to the effect that
10: New section 7A inserted
The following section is inserted after section 7
7A: Uncleared or unauthorised goods
1: The powers provided for in this section apply in respect of goods that are in a transitional facility or biosecurity control area (within the meaning of the Biosecurity Act 1993 sections 5 and 6 of this Act
2: An ACVM officer may seize any such goods that he or she has reasonable grounds to suspect—
a: do not comply with the requirements of this Act; or
b: constitute a risk to public health, agricultural security, trade in or market access for primary produce, the welfare of animals, or may breach domestic food residue standards.
3: The Director-General may, either generally or in any particular case, give any reasonable directions as to the disposal or treatment or destruction of, or any other dealing with, any goods seized under this section; and any person may dispose of, treat, destroy, or otherwise deal with the goods accordingly.
4: The Director-General may offer the importer or owner of any goods imported into New Zealand and seized under this section the option of exporting or returning the goods to their place of origin provided that the importer or owner undertakes the payment of any costs associated with the export or return of the goods.
5: The Director-General may hold goods seized under this section in his or her custody for such period as is necessary for the importer to obtain a clearance for entry into New Zealand in accordance with sections 5 and 6
6: In exercising his or her powers under this section, the Director-General must, so far as is practicable while achieving the purposes of this Act, act in a manner that is consistent with avoiding or minimising loss to the importer or owner of the goods seized.
7: All costs and expenses attendant upon the custody and disposal of goods seized under this section must be borne by the owner or other person in possession of the goods immediately before their seizure, and are recoverable from that person as a debt due to the Crown.
8: If however satisfied that the person in possession of the seized goods was not aware that they did not comply with the requirements of this Act, the Director-General may, at his or her absolute discretion, waive or reduce the amount otherwise recoverable under subsection (7)
11: New sections 8 to 8C substituted
Section 8
8: Prohibition on sale, use, manufacture, or import of agricultural compound
1: No person may sell within New Zealand, or use, any agricultural compound unless that agricultural compound—
a: is a registered trade name product; or
b: is exempt from registration under section 8A
2: No person may manufacture in New Zealand any agricultural compound unless that agricultural compound—
a: is a registered trade name product; or
b: is exempt from registration under section 8A
c: is manufactured for export only.
3: No person may import any agricultural compound into New Zealand unless that agricultural compound—
a: is a registered trade name product; or
b: is exempt from registration under section 8A
c: is only to be exported, with or without further processing.
8A: Exemptions from requirement to register
1: An agricultural compound is exempt from the requirement to be registered under this Part if—
a: it is exempt from registration by regulations made under section 75
b: it is listed by the Director-General under section 8B
c: it is approved by the Director-General under section 8C
2: An exemption under this section is valid only if the compound or substance complies with any relevant conditions or requirements set by the regulations, or by the Director-General under section 8B or 8C
8B: Director-General may list as exempt substances generally recognised as safe
1: The Director-General may from time to time determine that a substance is generally recognised as safe for use as or in an agricultural compound, and therefore need not be registered under this Part.
2: The determination may be that the substance is safe for use either—
a: without restriction; or
b: subject to conditions.
3: The Director-General must maintain a list of such substances. The list must contain any applicable conditions for their sale or use.
4: The Director-General must ensure that—
a: the list is available to the public for inspection free of charge; and
b: copies can be taken on payment of a reasonable charge (if any).
5: The Director-General must by notice in the Gazette
8C: Director-General may approve agricultural compound as exempt in special circumstances
1: The Director-General may approve the importation, manufacture, sale, or use of an agricultural compound without registration if the Director-General considers that special circumstances make it appropriate to grant the approval.
2: Sections 9 to 12
3: Sections 19 to 23 and section 25
4: In addition,—
a: in considering an application for approval, the Director-General must have regard to whether the agricultural compound concerned fulfils a need that cannot be met by any compound currently available in New Zealand:
b: in granting an approval, the Director-General may impose—
i: a condition that the agricultural compound must not be used on or in products intended for human consumption, or in circumstances that may result in the compound being consumed directly or indirectly by humans:
ii: a condition that the product cannot be imported, manufactured, sold, or used in circumstances other than those specified at the time of the approval.
5: The Director-General may at any time, on giving such notice as is reasonable in the circumstances, revoke an approval given under this section, or amend the terms or conditions of an approval.
6: A person who holds an approval may surrender the approval by notifying the Director-General in the form and manner specified by the Director-General.
7: The provisions of this Act do not give the holder of an approval the sole right to import, manufacture, sell, or use the agricultural compound that is the subject of the approval.
8: If a person acting under the delegated authority of the Director-General refuses to grant or revokes an approval under this section, or amends the terms or conditions of an approval, the applicant for or holder of the approval may seek a review of that refusal, revocation, or amendment under section 77A
12: Application for registration
Section 9(1)(b) by regulations made under section 75 under section 8A
13: Waiver of notification
Section 15(1) paragraph (b)
b: the application is made under section 9(2) section 21
14: Relevant risks and benefits
1: Section 19 paragraph (a)
a: risks to public health:
ab: risks to trade and market access for primary produce arising from the use of the trade name product: .
2: Section 19(e) , including consideration of whether alternative means of achieving the stated purpose of the trade name product are available
15: Term of registration
1: Section 22(2)(b) or manufacture sell
2: Section 22 subsection (3)
3: Where registration of a trade name product, other than a provisional registration under section 27 subsection (1) of this section
a: must remove the trade name product from the register under section 24
b: must, by notice in the Gazette
c: may allow the sale and use of the trade name product (but not its manufacture) to continue for a period specified in the Gazette
d: may require any person holding the trade name product—
i: to surrender that product to the Director-General; or
ii: to dispose of that product in the manner determined by the Director-General at the expense of the person holding the product.
16: Conditions on trade name products
1: Section 23(1) paragraph (f)
f: a condition requiring an operating plan approved by the Director-General under section 28 .
2: Section 23(1) paragraph (j)
ja: a condition requiring that persons who import, manufacture, sell, or use a trade name product must do so under the authority of, and in compliance with any requirements of, a recognised person or any class or description of recognised persons:
jb: a condition requiring that persons who authorise the use of a trade name product must do so in compliance with any requirements specified by the Director-General: .
3: Section 23(1) an inspector, or an authorised person paragraphs (k) and (l) or an ACVM officer
4: Section 23
4: The Director-General must not impose conditions under this section if he or she is satisfied that the relevant risks that the conditions would address are already adequately managed by conditions or controls imposed by or under any other Act.
5: The specificity of the conditions listed in paragraphs (a) to (l paragraph (m) of that subsection
5: Where any condition of registration imposed under section 23 of the principal Act
17: Register of agricultural compounds
1: Section 24(1) or section 27
2: Section 24 subsection (1)
1A: The register may be kept in such manner as the Director-General thinks fit.
3: Section 24(2)
a: by omitting sections 73, 109, and 121
c: and substituting section 73
b: by repealing paragraph (e)
c: by omitting or section 27 paragraph (f)
4: Section 24(2) paragraph (f)
fa: the date and period of any suspension of registration under section 30A .
5: Section 24(2) paragraph (j)
j: the name and contact details of the persons who are or will be manufacturing the trade name product; and .
6: Section 24(3)
7: Section 24(4) or any class or description of agricultural compounds agricultural compounds
18: Certificate of registration
1: Section 25(1) (e),
2: Section 25
3: The Director-General must keep a copy of—
a: each certificate of registration; and
b: each application for registration.
19: Application for provisional registration
Section 26(3) 19(a) 19(a), (ab)
20: Decision on application for provisional registration
Section 27(1) 19(a) 19(a), (ab)
21: New section 28 substituted
1: Section 28
28: Director-General may approve operating plans
1: This section applies where—
a: an approved operating plan is required as a condition of—
i: registration of a trade name product; or
ii: exemption under section 8A section 21 or 27
iii: recognition of a person under section 62
b: an operating plan is submitted to the Director-General for approval.
2: The Director-General may approve an operating plan submitted to him or her.
3: The Director-General may, by notice in writing, amend or revoke any approval of an operating plan under subsection (2)
2: Any code of practice approved under section 28 of the principal Act subsection (1) section 23(1)(f) section 75 section 28(2) of the principal Act
a: the expiry of 3 years from the commencement of this Act; or
b: the code's replacement by an operating plan or other relevant requirement imposed by or under regulations made under the principal Act.
22: New section 30A inserted
The following section is inserted after section 30
30A: Suspension of registration
1: The Director-General may at any time suspend registration of a trade name product registered under section 21 or section 27
2: The Director-General may impose conditions and requirements in respect of the implementation and operation of a suspension under this section.
3: Where the Director-General proposes to suspend registration under this section, he or she must give written notice of that fact to the registrant, specifying—
a: the reason for the suspension; and
b: the period of the suspension; and
c: the date on which or time at which it commences (which may not be earlier than the date or time of notification); and
d: any conditions or requirements in relation to the suspension.
4: If the Director-General considers it necessary in the circumstances, and after having notified the registrant of the proposed extension and the reasons for it, and having given the registrant a reasonable opportunity to be heard, the period of suspension may be extended once for such further period not exceeding 3 months as the Director-General notifies to the registrant in writing before the expiry of the original suspension.
5: The Director-General must notify any suspension of registration of a trade name product registered under section 21 Gazette
6: A suspension under this section does not affect any other actions that the Director-General or an ACVM officer may take under this Act.
7: Where registration is suspended under this section, the Director-General may direct the registrant to take action appropriate to deal with any affected trade name product, and may exercise any of his or her other powers.
8: If a person acting under the delegated authority of the Director-General suspends any registration under this section, the registrant may seek a review of the suspension under section 77A
9: The effect of a suspension of registration under this section is that no person may import, manufacture, sell, or use the relevant trade name product during the period of suspension, unless allowed to do so by a condition or requirement imposed under subsection (2)
23: New section 33 substituted
Section 33
33: No compensation or damages following reassessment of trade name product or revocation or amendment of approval
1: Where a registered trade name product is reassessed in accordance with section 29 or 30
2: Where an approval is revoked or amended in accordance with section 8C(5)
24: Transfer and surrender of registration
1: Section 34(1)(b) , by returning the certificate of registration to the Director-General
2: Section 34 subsection (1)
1A: A registrant who intends to transfer the registration to another person or to surrender the registration must notify the Director-General of that intention in the form and manner specified by the Director-General.
25: New headings and sections 35A to 35G inserted
The following headings and sections are inserted after section 35 Certificates of compliance for agricultural compounds
35A: Director-General may issue certificates of compliance
1: The Director-General, or a person authorised by the Director-General under section 35E
2: Without limiting the matters to which a certificate of compliance may apply, a certificate of compliance is a general statement attesting, in respect of an agricultural compound,—
a: that the agricultural compound complies with the requirements of this Act specified in the certificate of compliance:
b: if appropriate, that the situation in New Zealand in relation to any matter concerning agricultural compounds is as stated in the certificate of compliance.
3: A certificate of compliance is not a guarantee that the contents of all or any particular consignments of agricultural compounds to which it relates—
a: necessarily meet the requirements of any person relying on the certificate of compliance; or
b: are fit for use no matter what the status or description of the user or what has happened to the consignment or what has been its treatment since it left New Zealand; or
c: are fit for use for a purpose other than that for which they were intended.
35B: Form and content of certificate of compliance
1: A certificate of compliance may be in the form of a certificate or declaration or in such other form as the Director-General determines.
2: A certificate of compliance may relate to—
a: one or more consignments of agricultural compound; or
b: one or more export destinations; or
c: any combination of the above.
3: A certificate of compliance may be communicated to its appropriate destination by writing, fax, electronic means, or any other faint of communication that is accurate, clear, and verifiable.
35C: Obtaining of certificate of compliance
1: A person who wishes to obtain a certificate of compliance in respect of any agricultural compound may apply in a manner approved by the Director-General, and must supply any information required by the Director-General and pay any relevant fee.
2: The Director-General or person authorised under section 35E
35D: Certificate of compliance may be withdrawn, and reissued
1: A certificate of compliance may be withdrawn by the Director-General or other person authorised by the Director-General if the Director-General or person is satisfied that—
a: the certificate was incorrectly or inappropriately given; or
b: events or circumstances occurring since the certificate was issued mean that it no longer holds true, or is misleading.
2: The Director-General or other person authorised may, on application in a manner approved by the Director-General and on payment of the prescribed fee (if any), reissue a withdrawn certificate of compliance (with modifications, if appropriate) as a new certificate of compliance.
35E: Persons authorised to issue certificates of compliance
The Director-General may designate 1 or more persons employed within the Ministry as persons authorised to issue certificates of compliance for the purposes of this Act.
35F: No Crown liability
The Crown, the Director-General, and employees of the Ministry are not liable, by reason of the issue, refusal or failure to issue, or withdrawal of a certificate of compliance in respect of any agricultural compound, for any loss arising through the refusal or failure of the relevant authority of an overseas market to admit an agricultural compound intended to be exported to that market. Recall of agricultural compound
35G: Recall of agricultural compound
1: The Director-General may, by notice in writing, direct the recall of any agricultural compound for the purpose of rectification, disposal, or destruction if, in the opinion of the Director-General,—
a: the compound does not comply with any requirements of this Act or of regulations made under this Act; and
b: the non-compliance could result in serious or significant risk to the matters referred to in section 4
2: A notice under this section (a recall notice subsection (1)
3: A recall notice may be directed to any 1 or more persons who own or have control over the agricultural compound in question.
4: On receipt of a recall notice, the person on whom it is served must as soon as practicable—
a: advise the Director-General of the details of the manner in which the notice is to be complied with; and
b: give written notice to the Director-General when the recall, and any specified requirement associated with the recall, has been completed.
5: If a person who owns or has control of the agricultural compound fails or refuses to comply with a recall notice, the Director-General may—
a: take any reasonable steps necessary to give effect to the recall notice (including entry by ACVM officers into premises under a warrant); and
b: recover the costs and expenses reasonably incurred under paragraph (a)
26: Section 37 repealed
1: Section 37
2: Despite subsection (1)
27: Minister's power to call in applications with significant effects
Section 39(1) (other than an application for an approval under section 8C section 35C any application under this Act
28: Investigation by Board of Inquiry
Section 42(3) 19(a) 19(a), (ab)
2: Amendments to Parts 4 to 8 and Schedules of principal Act
29: Appeal on question of law
Section 46(1) paragraph (a)
ab: party to an application for an approval under section 8C .
30: Offences
1: Section 55(1) paragraph (b)
ba: knowingly manufactures any agricultural compound in contravention of this Act; or
bb: knowingly imports any agricultural compound in contravention of this Act; or .
2: Section 55(1) paragraph (d)
da: knowingly contravenes any conditions of an approval given under section 8B or 8C
db: knowingly imports, manufactures, sells, or uses a product while that product's registration is suspended under section 30A section 30A(2)
dc: knowingly contravenes or fails to comply with a condition or requirement imposed under section 30A(2)
dd: knowingly fails to comply with a direction given under section 30A(7)
de: knowingly contravenes the requirements of any recall notice issued under section 35G .
3: Section 55(1) ; or
j: knowingly supplies false or misleading information to the Director-General or an ACVM officer under this Act; or
k: knowingly supplies false or misleading information in support of an application under this Act; or
l: knowingly withholds relevant information from an ACVM officer or person assisting an ACVM officer.
4: Section 55 subsection (1)
1A: Every person commits an offence against this Act who, in contravention of an order made under section 57A(2) section 57A(4)
5: Section 55(2)
a: by repealing paragraphs (a) and (b)
b: by omitting inspector, authorised person, or accredited person paragraphs (c) and (d) ACVM officer or recognised person
6: Section 55(5) 2 years 4 years
31: Penalties
1: Section 56(1) paragraph (a)
a: in the case of a natural person, to a term of imprisonment not exceeding 2 years or a fine not exceeding $30,000, or both: .
2: Section 56 subsection (1)
1A: Every person who commits an offence against section 55(1A)
32: New section 57 substituted
Section 57
57: Revocation of registration or approval
1: When a registrant or an agent of a registrant is convicted of an offence against this Act, the Court may, instead of or in addition to a fine or imprisonment, revoke any registration held by that registrant of any trade name product.
2: When a holder of an approval under section 8C
33: New section 57A inserted
The following section is inserted after section 57
57A: Power to prohibit person from importing, manufacturing, selling, or using trade name product or agricultural compound
1: This section applies where—
a: a person is convicted of an offence under section 55(1)
i: the person has been convicted of a previous offence against section 55(1)
ii: the Court is of the opinion that by reason of the serious nature of the offence the person's activities relating to agricultural compounds should be restricted; or
b: a person is convicted of breaching a restriction order issued under this section.
2: The Court may, in addition to or substitution for any other penalty imposed on a person convicted of an offence to which this section applies, issue an order prohibiting the person from importing, manufacturing, selling, or using any trade name product or agricultural compound.
3: A person who is the subject of an order under subsection (2)
4: At the hearing of the application the Court may, if it thinks fit, having regard to—
a: the character of the applicant; and
b: the applicant's conduct since the order was made; and
c: the nature of the offence of which the applicant was convicted; and
d: any other circumstances of the case,— order that, as from a date to be specified in the order, the prohibition be removed or the order be varied, or refuse the application.
5: If the Court has, under subsection (4) subsection (3)
34: Appointment of inspectors
1: Section 60
a: by omitting from the section heading inspectors ACVM officers
b: by omitting from subsection (1) inspectors agricultural compounds and veterinary medicines officers ( ACVM officers
c: by omitting from subsection (2) inspector inspectors ACVM officer ACVM officers
d: by omitting from subsection (3) Inspectors ACVM officers
e: by omitting from subsection (4) inspectors inspector ACVM officers ACVM officer
2: A person appointed under section 60 of the principal Act
35: Section 61 repealed
Section 61
36: Appointment of accredited persons
Section 62
a: by omitting from the section heading accredited recognised
b: by omitting from subsection (1) accredit persons to carry out specified functions required under this Act recognise persons to carry out specified functions for the purposes of this Act
c: by omitting from subsection (2) accreditation recognition
d: by omitting from subsections (3), (4), and (5) accredited recognised
e: by omitting from subsection (6) accreditation recognition
2: A person accredited to carry out any specified functions under section 62 of the principal Act section 62 of the principal Act
37: New section 63 substituted
Section 63
63: Protection of ACVM officers and recognised persons
No action or proceedings may be brought against any ACVM officer or recognised person in respect of any actions taken by any such officer or person under this Act unless he or she has acted in bad faith or without reasonable cause .
38: Powers of entry for inspection
1: Section 64(1)
1: Any ACVM officer may enter or go on, into, under, or over any place (including, to avoid doubt, any transitional facility or biosecurity control area within the meaning of the Biosecurity Act 1993
1A: Subsection (1)
2: Section 64 inspector or authorised person subsections (2), (3), (3)(a), and (4) ACVM officer
39: New section 65 substituted
Section 65
65: ACVM officers may issue prohibition notices
1: Any ACVM officer who has reasonable grounds to believe that any person manufacturing, selling, importing or using any agricultural compound is acting in contravention of any provision of this Act, or any conditions on the registration of a trade name product or on an approval given under section 8C section 8B(2)
2: A prohibition notice issued under subsection (1)
3: A prohibition notice issued under subsection (1)
40: Matters may be completed by different inspectors or authorised persons
Section 67
a: by omitting from the section heading inspectors or authorised persons ACVM officers
b: by omitting inspector or authorised person ACVM officer
41: Issue of search warrants
1: Section 69(1)(a) or section 55(1A) section 55(1)
2: Section 69 inspector subsections (2) and (4) ACVM officer
42: Powers of entry with warrant
1: Section 70(1)
a: by omitting inspector ACVM officer
b: by inserting in paragraph (c)(i) or section 55(1A) section 55(1)
c: by inserting in paragraph (e) manufactured or agricultural compound
2: Section 70(1)(f)(i)
i: is a risk to public health, agricultural security, trade in or market access for primary produce, the welfare of animals, or may breach domestic food residue standards; and .
3: Section 70 inspector subsections (1)(f)(ii), (2), (3), and (4) ACVM officer
43: Disposal of property seized
Section 71(1)
a: by inserting under a search warrant issued under section 69 member of the Police
b: by omitting inspector ACVM officer under such a warrant
44: Regulations
1: Section 75(1)(a)
a: by omitting the prescribed conditions any prescribed conditions
b: by omitting a code of practice issued or an operating plan
2: Section 75(1) paragraph (c)
ca: prescribing procedures, processes, and requirements relating to conditions imposed at the time of registration of trade name products under section 21 or 27
cb: prescribing procedures, processes, and requirements relating to conditions on those substances exempt from registration as an agricultural compound under section 8B
cc: prescribing procedures, processes, and requirements for applying for registration of a trade name product:
cd: prescribing standards relevant to consideration of applications for registration of trade name products and the conditions imposed on registration, including, without limitation, standards in relation to—
i: manufacturing processes and facilities:
ii: packing, storage, transport, and handling:
iii: authorising the use of, selling, or supplying agricultural compounds:
iv: the activities or behaviour of persons recognised to carry out certain functions in relation to agricultural compounds:
v: identification and labelling:
vi: separating off portions of products into smaller quantities:
vii: any other matter relevant to the management of products, activities, or behaviour to minimise the risks specified in section 4 .
3: Section 75 subsection (1)
1A: Regulations made under this section—
a: may apply to all agricultural compounds or substances, any class or description of agricultural compounds or substances, or any particular agricultural compound or substance:
b: may authorise the Director-General to issue or impose any specifications or other detailed requirements that are necessary or desirable to amplify the manner in which the requirements of the regulations may or must be achieved.
4: Section 75 subsection (3)
3A: When recommending the making of regulations under this section, the Minister must have regard to the desirability of maintaining consistency between those regulations and any relevant international standards, requirements, or recommended practices.
45: New section 76A inserted
The following section is inserted after section 75
76A: Director-General may set specifications and other detailed requirements
1: The Director-General may from time to time issue notices setting specifications and other detailed requirements that—
a: are specified or contemplated by or necessary to give effect to any regulation made under section 75
b: are necessary or desirable to amplify the manner in which the requirements of any such regulation may or must be achieved.
2: Before issuing a notice under this section, the Director-General must do everything reasonably practicable to consult with the organisations for the time being recognised by the Director-General as representing the interests of persons who will or may be affected by the specifications or other detailed requirements contained in the notice.
3: Subsection (2)
4: A failure to comply with subsection (2)
5: Where a notice under this section affects only 1 person or a small number of persons, and the identity of those persons is known, the Director-General must—
a: notify the persons individually in writing, whether personally by post or facsimile addressed to the person, or by electronic means acceptable to the person; and
b: either—
i: supply them with a copy of the specifications or other requirements; or
ii: notify them where they may inspect a copy free of charge (which may include inspection by electronic means) or obtain a copy on payment of a reasonable charge.
6: Where it is not possible or practicable to notify a matter in accordance with subsection (5)
a: either publish the specifications or other requirements in the Gazette Gazette
b: where the Director-General considers it practicable, cause them to be brought to the attention of persons likely to be affected by them by notice or publication in any newspaper or trade journal, or by any other practicable means (including electronic means).
7: If the specifications or other requirements are notified only, and not published, in the Gazette
a: the Director-General must make copies available for inspection free of charge, and for purchase at a reasonable cost, at the head office of the Ministry and at such other places as the Director-General determines; and
b: the Gazette
46: Warranties
Section 77 by regulations made under section 75 under section 8A
47: New section 77A inserted
The following section is inserted after section 77
77A: Right of review of registration decisions made under delegated authority
1: This section applies to any decision made under any of sections 8C, 21, 27, and 30A
2: A person dissatisfied with any such decision may seek a review of the decision by the Director-General or by a person designated by the Director-General who was not involved in making the original decision.
3: An application for a review must—
a: be in writing; and
b: state the grounds on which it is believed that the original decision was inappropriate; and
c: be provided to the Director-General within 20 working days after the original decision was notified to the applicant.
4: The Director-General, or a person designated by the Director-General who was not involved in the original decision, must review the matter within 40 working days, or within such extended period not exceeding a further 20 working days as the Director-General or designated person may specify by notice in writing to the applicant.
5: For the purposes of a review, the Director-General or designated person may require the applicant to supply information additional to that contained in the application for review within a specified time. The time taken to supply any such information (or allowed for its supply, if the information is not in fact supplied) is not to be counted for the purposes of the time limits specified in subsection (4)
6: The decision sought to be reviewed remains valid unless and until altered by the Director-General or designated person.
7: The Director-General or designated person must, as soon as practicable, notify the applicant for review of his or her decision on the review in writing, giving reasons for the decision.
8: A decision by the Director-General under this section is final, unless determined otherwise by a court of law of competent jurisdiction.
48: Consultation before making of Orders in Council
Section 78(1) or section 81 section 81D, or section 81E
49: Relationship to other Acts
Section 79
a: by omitting the Dairy Industry Act 1952
b: by omitting the Meat Act 1981
c: by inserting the Wine Act 2003 Health Act 1956 section 138 of that Act the Food Act 1981
50: Correction of errors
Section 80 for that purpose, may require the registrant or any holder of an approval to produce the certificate of registration or any other document held by the registrant or holder of the approval
51: New headings and cost recovery sections substituted
Sections 81 to 83 Cost recovery
81: Principles of cost recovery
1: The Minister and the Director-General must take all reasonable steps to ensure that the direct and indirect costs of administering this Act that are not provided for by money appropriated by Parliament for the purpose are recovered under this section and sections 81A to 83 cost recovery sections
2: In determining the most appropriate method of cost recovery under section 81A
a: equity, in that funding for a particular function, power, or service, or a particular class of function, powers, or services, should generally, and to the extent practicable, be sourced from the users or beneficiaries of the relevant function, power, or service at a level commensurate with their use or benefit from the function, power, or service:
b: efficiency, in that costs should generally be allocated and recovered in order to ensure that maximum benefits are delivered at minimum cost:
c: justifiability, in that costs should be collected only to meet the reasonable costs (including indirect costs) for the provision or exercise of the relevant function, power, or service:
d: transparency, in that costs should be identified and allocated as closely as practicable in relation to tangible service provision for the recovery period in which the service is provided.
3: Costs should not be recovered under the cost recovery sections unless there has been appropriate consultation with affected parties and relevant industry organisations in accordance with section 78
4: Nothing in subsection (3) or section 78 or 81C section 78 subsection (3)
5: Nothing in this section requires a strict apportionment of the costs to be recovered for a particular function or service based on usage; and, without limiting the way in which fees or charges may be set, a fee or charge may be set at a level or in a way that—
a: is determined by calculations that involve an averaging of costs or potential costs:
b: takes into account costs or potential costs of services that are not directly to be provided to the person who pays the fee or charge but which are an indirect or potential cost arising from the delivery of the service in question to a class of persons or all persons who use the service.
81A: Methods of cost recovery
The methods by which costs may be recovered under the cost recovery sections are as follows:
a: fixed fees or charges:
b: fees or charges based on a scale or formula or at a rate determined on an hourly or other unit basis:
c: use of a formula or other method of calculation for fixing fees and charges:
d: the recovery by way of fee or charge of actual and reasonable costs expended in, or associated with, the performance of a service or function:
e: estimated fees or charges, or fees or charges based on estimated costs, paid before the provision of the service or function, followed by reconciliation and an appropriate further payment or refund after provision of the service or function:
f: refundable or non-refundable deposits paid before provision of the service or performance of the function:
g: fees or charges imposed on users of services or third parties:
h: levies:
i: any combination of the above.
81B: Cost recovery to relate generally to financial year
1: Except as provided in subsection (2)
a: must have been made before the start of that financial year; but
b: except as the regulations may otherwise provide, apply in that year and all subsequent years until revoked or replaced.
2: Subsection (1)
a: the fee, charge, or levy is reduced, removed, or restated without substantive alteration; or
b: in the case of an increase or a new fee, charge, or levy,—
i: appropriate consultation in accordance with section 78
ii: the Minister is satisfied that those persons, or their representatives, agree or do not substantially disagree with the alteration or setting.
3: Subsection (1)
4: Recovery may be made in any financial year of any shortfall in cost recovery for any of the preceding 4 financial years, and allowance may be made for any over-recovery of costs in those years (including any estimated shortfall or over-recovery for the immediately preceding financial year).
81C: Three-yearly review of cost recovery
1: The Minister must cause to be reviewed, at least once in every 3-year period occurring since the original setting of, or latest change to, the levels and methods of cost recovery in relation to any class of agricultural compound, business, person, or other matter, the levels and methods of cost recovery in the relevant area that are likely to be appropriate for the following financial year or years.
2: The Minister must ensure that appropriate consultation in accordance with section 78
3: A review may make provision for recovery in any relevant financial year of any shortfall in cost recovery for any of the preceding 4 financial years, or make allowance for any over-recovery of costs in those years (including any estimated shortfall or over-recovery for the immediately preceding financial year).
4: Subsection (1)
81D: Fees and charges to be prescribed by regulations
1: Regulations may be made under this Act, on the recommendation of the Minister, prescribing fees and charges for the purposes of this Act.
2: The fees and charges may be prescribed using any 1 or more of the methods specified in section 81A
3: Different fees and charges, or different rates or types of fee or charge, may be prescribed in respect of different classes or descriptions of agricultural compound, persons or businesses, operations, or other matters, or any combination of them.
4: Without limiting subsection (3)
a: differ depending on whether or not a special or urgent service is provided:
b: include more than 1 level of fee or charge for the same service provided in different ways, or provided in or in respect of different places:
c: differ for otherwise similar services provided in different ways:
d: differ for otherwise similar services provided to different categories of person:
e: differ depending on the amount of service required or the components of the service required for the particular person or class of person.
5: Where regulations prescribe a formula for determining a fee or charge, the formula may specify the value of 1 or more of its components as being an amount or amounts notified for these components by the Director-General by notice in the Gazette
6: The Minister may not recommend the making of regulations under this section unless satisfied that, to the extent appropriate in the circumstances, the requirements of sections 81 and 81B
81E: Regulations may impose levies
1: Regulations may be made under this Act, on the recommendation of the Minister, prescribing levies for the purposes of this Act.
2: Different levies or rates of levy or bases on which an amount of levy is to be calculated or ascertained may be prescribed for different purposes, and different levies or rates of levy or bases for calculation may be set for different classes or descriptions of agricultural compound, persons or businesses, operations, or other matters, or any combination of them.
3: Without limiting the generality of subsection (1)
a: specify when and how any levy is to be paid:
b: require that any levy, or estimated amount of levy, be paid in advance of performance of the services or functions to which it relates:
c: specify persons, other than persons primarily responsible for paying the levy, who are to be responsible for collecting a levy, and provide for retention of any part of the levy money collected as a fee for that service:
d: require, or empower the Director-General to require, the provision of information and returns in relation to levies:
e: require the keeping of separate trust accounts for levy money received or deducted by persons responsible for collecting levies, and prescribe matters in relation to those trust accounts:
f: prescribe a method of arbitration or mediation in the case of disputes as to—
i: whether or not any person is required to pay, or collect, the levy concerned; or
ii: the amount of levy any person is required to pay or collect:
g: provide for related matters, including procedures and remuneration for arbitrators or mediators.
4: The Minister may not recommend the making of regulations under this section unless satisfied that, to the extent appropriate in the circumstances, the requirements of sections 81 and 81B
81F: Trust accounts required to be kept by persons collecting levies
1: If regulations made under section 81E
a: any amount held in such an account that is due to be paid to the Director-General by the levy collector is to be treated as levy money held on trust for the Director-General; and
b: any amount so held on trust is not available for the payment of any creditor (other than the Director-General) of the levy collector, and is not liable to be attached or taken in execution at the instance of any such creditor; and
c: a person who ceases to be a person responsible for collecting a levy must continue to maintain the trust account until all the levy money payable to the Director-General in respect of the period during which the person was responsible for collecting the levy has been paid.
2: Nothing in subsection (1)(c)
81G: Other charges not requiring to be prescribed
1: Nothing in the cost recovery sections or in any other provision of this Act prevents the Director-General from requiring a reasonable charge to be paid for any of the services the Ministry provides in relation to the administration of this Act, or any actual and reasonable expenses incurred in providing the services, other than services in respect of which a fee or charge or levy is prescribed under these cost recovery sections.
2: Without limiting subsection (1)
a: operate a telephone information service for which each caller pays according to their usage or on some averaged basis:
b: charge persons for the cost of mailing, faxing, emailing, or couriering information to them:
c: charge for the cost of written material, unless that material is required by an Act or by regulations made under this Act to be provided free of charge:
d: charge for access to any website, or for information or services provided by any website, operated by the Ministry:
e: charge for access to any library or research services provided in relation to matters pertaining to agricultural compounds, or associated things:
f: charge any person for services provided in relation to a business importing, manufacturing, selling, or using agricultural compounds or otherwise under this Act.
3: All money received as a result of such charges received by the Ministry must be paid into the Departmental Bank Account.
81H: Exemptions, waivers, and refunds
1: Regulations made under this Act may provide for exemptions from, or waivers or refunds of, any fee, levy, or charge payable under this Act, in whole or in part, in any particular case or class of case.
2: Any such regulations may authorise the Director-General to grant an exemption, waiver, or refund in any particular case or class of case.
81I: Fees, levies, and charges to constitute debt due to Director-General
Any fee, levy, or charge that has become payable is a debt due to the Director-General, and is recoverable as a debt by the Director-General in any court of competent jurisdiction. Until paid in full, it remains a debt due to the Crown.
81J: Penalties for failure to pay fee, levy, or charge
1: If a person has failed to pay to the Director-General by the due date any fee, levy, or charge payable under this Act,—
a: section 14 of the Ministries of Agriculture and Forestry (Restructuring) Act 1997
b: section 15 of that Act
c: section 16 of that Act
2: For the purposes of subsection (1)(c) of this section section 16 of the Ministries of Agriculture and Forestry (Restructuring) Act 1997 section 16
a: withhold or suspend any registration or approval under this Act, or refuse to perform any function under this Act in relation to the person in default:
b: withhold any certificate of compliance.
3: Where any registration or approval is suspended under subsection (2)(a)
4: Where the withholding, withdrawal, or suspension of any approval or registration under this section requires the Director-General to provide any further service, or perform any further function involved in the withholding, withdrawal, or suspension, the Director-General may recover any reasonable amount for the additional service, function, or costs as a debt due from the person in default.
81K: Obligation to pay fee, levy, or charge not suspended by dispute
The obligation of a person to pay any fee, levy, or charge under this Act (including any penalty referred to in section 81J
81L: Levy regulations to be confirmed
1: Where regulations imposing a levy have been made under the cost recovery sections on or after 1 January in any year and before 1 July in that year, and—
a: have not been revoked with effect on or before 1 July in the next year; and
b: have not ceased, and will not cease, to have effect on or before 1 July in the next year by virtue of the Regulations (Disallowance) Act 1989 they are to be treated as having been revoked with the close of 30 June in that next year unless confirmed by an Act of Parliament passed on or before that day.
2: Where any regulations imposing a levy have been made under the cost recovery sections after 30 June in any year and on or before 31 December in that year, and—
a: have not been revoked with effect on or before 1 January in the year after the next year; and
b: have not ceased, and will not cease, to have effect on or before 1 January in the year after the next year by virtue of the Regulations (Disallowance) Act 1989 they are to be treated as having been revoked with the close of 31 December in the year after the year in which they were made, unless confirmed by an Act of Parliament passed on or before that day.
52: New heading inserted
The heading Amendments, repeals, and revocations section 84
53: Part 8 repealed
Part 8 sections 87 to 122
54: Schedule 1 amended
Schedule 1 inspector ACVM officer
55: Schedule 5 repealed
Schedule 5
56: Regulations revoked
The following regulations are revoked:
a: the Agricultural Compounds and Veterinary Medicines (Transitional Provisions) Regulations 2002 (SR 2002/136)
b: the Animal Remedies (Fees) Regulations 1997 (SR 1997/367)
c: the Pesticides Act Commencement Order 1981 (SR 1981/177)
d: the Pesticides Act Commencement Order 1983 (SR 1983/15)
e: the Pesticides Amendment Act Commencement Order 1994 (SR 1994/308)
f: the Pesticides (Fees) Regulations 1997 (SR 1997/368) 2007-10-18 Agricultural Compounds and Veterinary Medicines (Transitional Provisions) Regulations 2002 (SR 2002/136) Animal Remedies (Fees) Regulations 1997 (SR 1997/367) Pesticides Act Commencement Order 1981 (SR 1981/177) Pesticides Act Commencement Order 1983 (SR 1983/15) Pesticides Amendment Act Commencement Order 1994 Pesticides (Fees) Regulations 1997 (SR 1997/368)
57: Agricultural Compounds and Veterinary Medicines Regulations 2001 amended
1: Regulation 3 of the Agricultural Compounds and Veterinary Medicines Regulations 2001 Regulations animal material approved operating plan section 28(2) of the Act section 21(2) of the Agricultural Compounds and Veterinary Medicines Amendment Act 2007 section 28(2) of the Act .
2: Regulation 3 of the Regulations good manufacturing practice good manufacturing practice .
3: Regulation 4 of the Regulations
a: by omitting codes of practice approved operating plans
b: by omitting codes of practice approved operating plans
4: Schedule 1 of the Regulations
a: by omitting codes of practice approved operating plans
b: by omitting code of practice in force under section 28 of the Act approved operating plan
5: Schedule 2 of the Regulations
a: by omitting code of practice in force under section 28 of the Act approved operating plan
b: by omitting code of practice must be in force under section 28 of the Act operating plan must have been approved 2007-10-18 Agricultural Compounds and Veterinary Medicines Regulations 2001