“ACVM officer means a person for the time being appointed as an ACVM officer under section 60”.

“agricultural compound means—

• “(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)”.

“Ministry means the Ministry that, with the authority of the Prime Minister, has for the time being assumed responsibility for the administration of this Act”.

“operating plan means a plan approved under section 28(2), and includes a code of practice deemed by section 21(2) of the Agricultural Compounds and Veterinary Medicines Amendment Act 2007 to be an operating plan approved under section 28(2)”.

“public health means the health of all of—

• “(a) the people of New Zealand; or

• “(b) a community or section of such people

“recognised person means a person for the time being appointed as a recognised person under section 62”.

• “(ai) risks to public health; and”.

“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, the Food Act 1981, the Wine Act 2003, the Animal Welfare Act 1999, the Biosecurity Act 1993, the Medicines Act 1981, and the Hazardous Substances and New Organisms Act 1986. Generally, the outcomes for which this Act regulates are those set under the other related Acts. For example:

  • “(a) maximum residue limits for food products are set under the Food Act 1981; while

  • “(b) this Act assesses and controls agricultural compounds to ensure the Food Act residue limit is not breached.”

• “(iii) the goods are an agricultural compound and are exempt from registration as a trade name product under section 8A; and”.

“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) that have not been cleared in accordance with 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. In such a case the estimated costs and expenses of the custody and maintenance of the goods must be paid in advance to the Director-General.

  “(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).”

“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; or

  “(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; or

  • “(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; or

  • “(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; or

  • “(b) it is listed by the Director-General under section 8B as a substance generally recognised as safe for use as or in an agricultural compound; or

  • “(c) it is approved by the Director-General under section 8C on the basis of special circumstances.

  “(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 notify the making of any addition or amendment to, or deletion from, the list, but the substances concerned need not be specified in the notice.

“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, with any necessary or appropriate modifications, apply to applications for approval under this section.

  “(3) Sections 19 to 23 and section 25, with any necessary or appropriate modifications, apply to the Director-General's consideration of an application for approval under this section, and the terms and conditions of any approval.

  “(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.”

• “(b) the application is made under section 9(2) and the proposed variation of conditions does not affect the evaluation of the risks relevant to the trade name product under section 21, when compared to the original evaluation under that section.”

• “(a) risks to public health:

• “(ab) risks to trade and market access for primary produce arising from the use of the trade name product:”.

• “(3) Where registration of a trade name product, other than a provisional registration under section 27, has ceased in accordance with a provision in subsection (1) of this section, the Director-General—

  • “(a) must remove the trade name product from the register under section 24; and

  • “(b) must, by notice in the Gazette, give notice of the removal of the trade name product from the register; and

  • “(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 notice; and

  • “(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.”

• “(f) a condition requiring an operating plan approved by the Director-General under section 28 to be followed when importing, manufacturing, selling, distributing, storing, transporting, or using the trade name product:”.

• “(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:”.

• “(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) of subsection (1) does not limit the conditions that may be imposed under paragraph (m) of that subsection.”

• “(1A) The register may be kept in such manner as the Director-General thinks fit.”

• “(fa) the date and period of any suspension of registration under section 30A, and a brief indication of the reason for the suspension; and”.

• “(j) the name and contact details of the persons who are or will be manufacturing the trade name product; and”.

• “(3) The Director-General must keep a copy of—

  • “(a) each certificate of registration; and

  • “(b) each application for registration.”

“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 from the requirement to be registered under section 21 or 27; or

    • “(iii) recognition of a person under section 62 in relation to the performance of certain functions:

  • “(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), following consultation with the person whose operating plan it is.”

“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 for a period of up to 3 months if the Director-General has reasonable grounds to believe that any condition imposed upon registration is not being complied with.

  “(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 in the 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).”

“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, no compensation or damages are payable to any person for any loss whatsoever arising out of the reassessment.

  “(2) Where an approval is revoked or amended in accordance with section 8C(5), no compensation or damages are payable to any person for any loss whatsoever arising out of the revocation or amendment.”

• “(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.”

“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, may issue a certificate of compliance in respect of any agricultural compound.

  “(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 need not issue a certificate of compliance unless satisfied that the information obtained from the applicant justifies the giving of the certificate of compliance.

“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) may require any person holding the agricultural compound to rectify the non-compliance under subsection (1), or dispose of or destroy the compound in the manner determined by the Director-General at the expense of the person holding the compound.

  “(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) as a debt due from that person.”

• “(ab) party to an application for an approval under section 8C; or”.

• “(ba) knowingly manufactures any agricultural compound in contravention of this Act; or

• “(bb) knowingly imports any agricultural compound in contravention of this Act; or”.

• “(da) knowingly contravenes any conditions of an approval given under section 8B or 8C; or

• “(db) knowingly imports, manufactures, sells, or uses a product while that product's registration is suspended under section 30A, unless allowed to do so by a condition or requirement imposed under section 30A(2); or

• “(dc) knowingly contravenes or fails to comply with a condition or requirement imposed under section 30A(2); or

• “(dd) knowingly fails to comply with a direction given under section 30A(7); or

• “(de) knowingly contravenes the requirements of any recall notice issued under section 35G; 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.”

• “(1A) Every person commits an offence against this Act who, in contravention of an order made under section 57A(2), or in contravention of such an order as varied under section 57A(4), imports, manufactures, sells, or uses any trade name product or agricultural compound.”

• “(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:”.

• “(1A) Every person who commits an offence against section 55(1A) is liable on summary conviction to a term of imprisonment not exceeding 2 years or a fine not exceeding $60,000, or both.”

“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, or any agent of such a holder, is convicted of an offence against this Act, the Court may, instead of or in addition to a fine or imprisonment, revoke the approval.”

“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) and either—

    • “(i) the person has been convicted of a previous offence against section 55(1); or

    • “(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) may, at any time after the expiration of 12 months from the date of the order, apply to the Court for the cancellation of the order.

  “(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), ordered that the order be varied or has refused the application, the person may not make a further application under subsection (3) within 12 months after the date of the order of variation or the refusal.”

“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”.

• “(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) for the purpose of inspection to determine whether or not any person is complying with this Act.

• “(1A) Subsection (1) does not apply to a place that is a dwellinghouse or a marae.”

“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 or any conditions determined under section 8B(2), may give written notice to that person prohibiting the manufacture, sale, import, or use of that product or that agricultural compound by that person until such time as the contravention of the Act is rectified to the satisfaction of the ACVM officer.

  “(2) A prohibition notice issued under subsection (1) must specify the contravention to which it relates, the action required to remedy the contravention, and the prohibition placed upon the manufacture, sale, import, or use of a trade name product or an agricultural compound.

  “(3) A prohibition notice issued under subsection (1) may be issued subject to such conditions as the persons issuing it considers appropriate.”

• “(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”.

• “(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:”.

• “(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.”

• “(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.”

“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; or

  • “(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) does not apply where the Director-General considers it desirable in the public interest that the notice be issued urgently.

  “(4) A failure to comply with subsection (2) does not affect the validity of a notice issued under this section.

  “(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), the Director-General must—

  • “(a) either publish the specifications or other requirements in the Gazette, or notify their making or existence in the Gazette; and

  • “(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 notice must specify where a copy may be inspected or obtained.”

“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 by a person acting under the delegated authority of the Director-General.

  “(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.”

“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 (referred to in this section and those sections as the cost recovery sections), whether by way of fees, levies, or otherwise.

  “(2) In determining the most appropriate method of cost recovery under section 81A, and its level, in any particular case or class of cases of agricultural compound, business, person, or other matter, the Minister and Director-General must have regard, as far as is reasonably practicable, to the following criteria:

  • “(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, and the parties involved have been given sufficient time and information to make an informed contribution.

  “(4) Nothing in subsection (3) or section 78 or 81C requires consultation in relation to specific fees or charges, or the specific levels of fees or charges, so long as the fees or charges set are reasonably within the purview of any general consultation or any consultation carried out for the purposes of section 78, and a failure to comply with subsection (3) does not affect the validity of any regulations made for the purposes of these cost recovery sections.

  “(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), any regulations under the cost recovery sections that set a fee, charge, or levy that applies in any financial year—

  • “(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) does not prevent the alteration or setting during any financial year of a fee, charge, or levy payable in that year if either—

  • “(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 has been carried out with persons or representatives of persons substantially affected by the alteration or setting; and

    • “(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) does not prevent the amendment of any regulation setting a fee, charge, or levy if any substantive alteration effected by the amendment is for the purpose of correcting an error.

  “(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 takes place in relation to any such review.

  “(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) does not require all areas of cost recovery to be reviewed at the same time, nor does it impose any time limit on the making of regulations to implement the results of a review.

“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, or any combination of those methods.

  “(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), the fees and charges prescribed may—

  • “(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 have been met.

“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), regulations imposing levies may—

  • “(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 have been met.

“81F Trust accounts required to be kept by persons collecting levies

• “(1) If regulations made under section 81E require the operation of a trust account for any levy money by the person responsible for collecting the levy,—

  • “(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) affects any obligation or liability under this Act of any other person who has become responsible for collecting the levy concerned.

“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), and for the avoidance of doubt, the Director-General may—

  • “(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 applies to increase the amount payable; and

  • “(b) section 15 of that Act applies to allow the Director-General, in appropriate cases, to waive the payment of all or any of the amount of any such increase; and

  • “(c) section 16 of that Act applies to allow the Director-General to withdraw, or refuse to provide the person in default with, any service of the kind to which the debt relates.

  “(2) For the purposes of subsection (1)(c) of this section and section 16 of the Ministries of Agriculture and Forestry (Restructuring) Act 1997, and without limiting the generality of that section 16, the references in those provisions to the withdrawal or refusal to provide any service are to be treated as also authorising the Director-General, in an appropriate case, to—

  • “(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), no person may import, manufacture, or sell a trade name product or agricultural compound under the authority of that registration or approval.

  “(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), and the right of the Director-General to receive and recover the fee, levy, charge, or penalty, are not suspended by any dispute between the person and the Director-General regarding the person's liability to pay the fee, levy, or charge, or the amount of the fee, levy, or charge.

“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.”

“approved operating plan means an operating plan approved under section 28(2) of the Act; and includes a code of practice deemed by section 21(2) of the Agricultural Compounds and Veterinary Medicines Amendment Act 2007 to be an operating plan approved under section 28(2) of the Act”.

“good manufacturing practice means a practice that follows an approved operating plan”.