“conditional release approval means an approval under section 38C

“conditionally released new organism means a new organism that is subject to a conditional release approval

“host organism means an organism that is the subject of a genetic modification procedure

“human cells —

• “(a) means human cells, human cell lines, or human tissues that are being grown or maintained outside the human body; and

• “(b) includes human reproductive cells or human embryonic cells that are being grown or maintained outside the human body

“prescribed means prescribed by regulations made under this Act

“qualifying medicine means a medicine or new medicine (as defined in section 3 of the Medicines Act 1981) that—

• “(a) is or contains a new organism; and

• “(b) meets the criteria set out in section 38I(3)

“qualifying organism means a new organism that is or is contained in a qualifying medicine or qualifying veterinary medicine

“qualifying veterinary medicine means a veterinary medicine (as defined in section 2(1) of the Agricultural Compounds and Veterinary Medicines Act 1997) that—

• “(a) is or contains a new organism; and

• “(b) meets the criteria set out in section 38I(3)

“responsible chief executive means the chief executive of the Authority and the chief executive of the department for the time being responsible for the administration of the Medicines Act 1981 or the Agricultural Compounds and Veterinary Medicines Act 1997, as the case may be

“taxonomic classification, in relation to an organism, means the genus, species, subspecies, infrasubspecies, variety, strain, cultivar, or other appropriate classification that the organism belongs to”.

“develop, in relation to organisms,—

• “(a) means—

  • “(i) genetic modification of an organism:

  • “(ii) regeneration of a new organism from biological material of the organism that cannot, without human intervention, be used to reproduce the organism:

  • “(iii) fermentation of a micro-organism that is a new organism; but

• “(b) does not include field testing”.

• “(a) does not include a human being:

• “(ab) includes a human cell:”.

• “(ca) an organism for which a conditional release approval has been given:

• “(cb) a qualifying organism approved for release with controls:”.

• “(2) An organism is not a new organism if—

  • “(a) the organism is not a genetically modified organism and—

    • “(i) an approval is granted under section 38 to release an organism of the same taxonomic classification; or

    • “(ii) the organism is a qualifying organism and an approval has been granted under section 38I to release an organism of the same taxonomic classification without controls; or

    • “(iii) an organism of the same taxonomic classification has been prescribed as not a new organism; or

  • “(b) the organism is a genetically modified organism and—

    • “(i) an approval is granted under section 38 to release an organism of the same taxonomic classification with the same genetic modification; or

    • “(ii) the organism is a qualifying organism and an approval has been granted under section 38I to release an organism of the same taxonomic classification with the same genetic modification without controls; or

    • “(iii) an organism of the same taxonomic classification with the same genetic modification has been prescribed as not a new organism; or

  • “(c) the new organism was deemed to be a new organism under section 255 and other organisms of the same taxonomic classification were lawfully present in New Zealand before the commencement of that section and in a place that was not registered as a circus or zoo under the Zoological Gardens Regulations 1977.

• “(2A) A new organism does not cease to be a new organism because—

  • “(a) it is subject to a conditional release approval; or

  • “(b) it is a qualifying organism approved for release with controls.”

• “(e) the economic and related benefits and costs of using a particular hazardous substance or new organism.”

• “(fb) approve standards for containment facilities:”.

• “(2) The Authority must, before exercising the function specified in subsection (1)(fb), consult the persons whom the Authority considers are representative of the classes of person who are likely to have an interest in the standards.”

• “(2) In subsection (1), matters includes matters relating to the Treaty of Waitangi and tikanga Maori.”

• “(ba) the power to assess and approve an application under section 38I(1) for the release of a qualifying organism to the responsible chief executive:

• “(bb) the power to determine whether a medicine or veterinary medicine is a qualifying medicine or qualifying veterinary medicine to the responsible chief executive:

• “(bc) the power to review and amend controls under section 38L in relation to qualifying medicines and qualifying veterinary medicines to the responsible chief executive:

• “(bd) the power to impose controls under section 45(2) in relation to a genetically modified human cell to which section 55 of the Hazardous Substances and New Organisms Amendment Act 2003 applies:”.

• “(ca) if applicable, the project concerned:”.

“Part 4A
“Nga Kaihautu Tikanga Taiao

“24A Establishment of Nga Kaihautu Tikanga Taiao

• This section establishes a committee to be called Nga Kaihautu Tikanga Taiao.

“24B Function of Nga Kaihautu Tikanga Taiao

• “(1) The function of Nga Kaihautu Tikanga Taiao is to provide advice and assistance to the Authority as sought by the Authority on matters relating to policy, process, and applications.

  “(2) The advice and assistance must be given from the Maori perspective and come within terms of reference set by the Authority for Nga Kaihautu Tikanga Taiao.

“24C Appointment and remuneration of members and chair

• “(1) The Authority must appoint not fewer than 4 and not more than 8 members of Nga Kaihautu Tikanga Taiao.

  “(2) The Authority must appoint 1 of the members to be the chairperson of Nga Kaihautu Tikanga Taiao.

  “(3) The members of Nga Kaihautu Tikanga Taiao are entitled to be paid remuneration at a rate set by the Authority.

“24D Review of terms of reference

• The Authority must, at intervals of not more than 3 years, review the terms of reference set by it for Nga Kaihautu Tikanga Taiao.”

• “(3) If an organism has a conditional release approval, no further approvals are required for the conditional release of the organism on the same conditions.

• “(4) If an organism has an approval for importation into containment, no further approvals are required for the importation into containment of the organism.

• “(5) The prohibition on the importation of a new organism does not apply to biological material of the organism that cannot, without human intervention, be used to reproduce the organism.

• “(6) No person may do any of the things specified in subsection (1)(a) or (b) in relation to any hazardous substance or new organism that is the subject of an innovative agricultural compound application or an innovative medicine application unless the person has applied for and been granted an approval to do that thing.

• “(7) Subsection (6) ceases to apply in respect of a hazardous substance or new organism on the date that section 55(3) to (4B) ceases to apply either to the Authority or to any information held by the Authority in relation to the hazardous substance or new organism concerned.

• “(8) In this section,—

  “innovative agricultural compound application has the same meaning as in section 72 of the Agricultural Compounds and Veterinary Medicines Act 1997

  “innovative medicine application has the same meaning as in section 23A of the Medicines Act 1981.”

• “(ba) a conditional release approval to import for release or release from containment a new organism:

• “(bb) an approval to import for release or to release from containment a qualifying organism:”.

• “(f) an approval to import an agricultural compound or medicine for release in a special emergency, release an agricultural compound or medicine from containment in a special emergency, or use an agricultural compound or a medicine in a special emergency.”

“27A Approvals at any taxonomic classification

• “(1) An approval referred to in section 27(b), (ba), (bb), or (c) may be granted for a new organism at any taxonomic classification that the Authority thinks fit.

  “(2) An approval that is granted for a new organism (that is not a genetically modified organism) in a taxonomic classification applies to all the organisms in the taxonomic classification.

  “(3) An approval that is granted for a genetically modified organism in a taxonomic classification applies only to organisms in the taxonomic classification with the same genetic modification as specified in the approval.

  “(4) Despite subsections (2) and (3), an approval may exclude any organism or groups of organisms from its scope.”

“34A Applications for conditional release and for release in respect of same new organism

• “(1) The user of a conditional release approval may, at or after the time of applying for the approval, apply to the Authority for approval to release the new organism at the expiry of the conditional release approval.

  “(2) The application must be treated as if it were an application under section 34 to release the new organism from containment.

  “(3) If the application is granted, the approval takes effect immediately after the expiry of the conditional release approval.”

• “(2) An approval under subsection (1) must be granted without controls.”

• “(3A) However, subsection (3) does not apply to an approval under this section that takes effect on the expiry of a conditional release approval.”

“Conditional release of new organisms

“38A Application for approval to import or release new organism with controls

• “(1) A person may apply to the Authority for a conditional release approval to import for release or to release from containment a new organism with controls.

  “(2) An application for a conditional release approval must be in the approved form and must include—

  • “(a) all prescribed information (if any); and

  • “(b) information on all occasions where the organism has been considered by the government of any prescribed state or country or by any prescribed organisation and the results of the consideration; and

  • “(c) the identification of the organism; and

  • “(d) any likely inseparable organisms; and

  • “(e) all the possible adverse effects of the organism on the environment; and

  • “(f) the affinities of the organism with other organisms in New Zealand; and

  • “(g) the proposed use for the organism; and

  • “(h) the controls that the applicant proposes the organism would be subject to on its release.

  “(3) The Authority may, by written notice given to the applicant, require the applicant to verify an application by statutory declaration.

  “(4) Any applicant may, by written notice to the Authority, withdraw the application at any time.

“38B Application under section 34 may be treated as application under section 38A

• The Authority may, with the agreement of the applicant, treat an application made under section 34 as if it were an application made under section 38A.

“38C Determination of applications to import or release new organisms with controls

• “(1) The Authority may approve an application made under section 38A and grant a conditional release approval with controls, but only if the Authority determines that,—

  • “(a) after taking into account the matters in subsection (3), the new organism is likely to meet the minimum standards set out in section 36; and

  • “(b) there is sufficient information available to assess the adverse effects of the organism; and

  • “(c) after taking into account the matters in subsection (2), the positive effects of the organism outweigh the adverse effects of the organism and any inseparable organism.

  “(2) The matters to be taken into account under subsection (1)(c) are—

  • “(a) all the effects of the organism and any inseparable organism; and

  • “(b) the ability of the organism to establish a self-sustaining population; and

  • “(c) the ease with which the organism could be recovered or eradicated if it established an undesirable self-sustaining population; and

  • “(d) all the controls that will be imposed on the organism.

  “(3) The matters to be taken into account in subsection (1)(a) are—

  • “(a) the controls that will be imposed on the approval; and

  • “(b) whether the controls are likely to be effective in meeting the objective of the controls; and

  • “(c) the ease with which the organism could be recovered or eradicated if it formed a self-sustaining population.

“38D Controls

• “(1) The controls that the Authority may impose on a conditional release approval include—

  • “(a) controlling the extent and purposes for which organisms could be used:

  • “(b) requiring any monitoring, auditing, reporting, and record-keeping:

  • “(c) imposing any obligation to comply with relevant codes of practice or standards (for example, to meet particular co-existence requirements):

  • “(d) requiring contingency plans to be developed to manage potential incidents:

  • “(e) limiting the dissemination or persistence of the organism or its genetic material in the environment:

  • “(f) requiring the disposal of any organisms or genetic material:

  • “(g) limiting the proximity of the organism to other organisms, including those that could be at risk from the conditionally released organism:

  • “(h) setting requirements that must be met for any material derived from the organism:

  • “(i) imposing obligations on the user of an approval, including levels of training or knowledge, limits on the numbers of users who may hold an approval, and the persons that they could deal with in respect of the organism:

  • “(j) specifying the duration of the approval or of a control before requiring review by the Authority, and the nature of that review.

  “(2) Subsection (1) does not limit the type of controls the Authority may impose on a conditional release approval.

“38E Duration of conditional release approval

• “(1) A conditional release approval that expressly states that it does not expire expires on the close of the date on which the last control to which the approval relates expires.

  “(2) In any other case, a conditional release approval expires on the earlier of the following:

  • “(a) the date of expiry (if any) specified in the approval; or

  • “(b) if no date of expiry is specified, 5 years after the date on which the approval is granted; or

  • “(c) the close of the date on which the last control to which the approval relates expires.

“38F Consequences of expiry of conditional release approval

• On the expiry of a conditional release approval, the new organism concerned must be disposed of unless, before the expiry of the approval, another approval has been granted under this Act.

“38G Review of controls on conditional release approval

• “(1) The Authority may, on its own initiative or on the application of any user of a conditional release approval or of any person specified in section 97 or section 97A, review the controls that it has imposed on the conditional release approval, but only if—

  • “(a) the review is to amend a control so that it better meets the objective of the control; or

  • “(b) the control included a review requirement specifying—

    • “(i) the circumstances in which the control would be reviewed; and

    • “(ii) the potential consequences of the review.

  “(2) The Authority—

  • “(a) may carry out the review without publicly notifying the review in accordance with section 53; but

  • “(b) if it does so, must—

    • “(i) consult, and consider the views of, the Department of Conservation and any other government agency (as defined in section 49A) that the Authority considers is likely to have an interest in the review; and

    • “(ii) publicly notify the results of the review.

  “(3) This section does not limit section 67A.

“38H Restriction on release of new organism subject to conditional release approval

• A person who did not obtain a conditional release approval for a new organism that is subject to a conditional release approval must not release the new organism in accordance with the approval unless, before the release, the person has given notice in writing to the Authority of the proposed release.

“Release of qualifying organisms

“38I Assessment of applications for release of qualifying organisms

• “(1) If the Authority receives an application under section 34 that relates to a qualifying organism, the Authority may—

  • “(a) make a rapid assessment of the adverse effects of importing for release or releasing from containment the qualifying organism; and

  • “(b) approve the importation for release or the release from containment of the qualifying organism with or without controls.

  “(2) If the Authority does not approve an application under this section, the Authority must assess and determine the application under section 38.

  “(3) The Authority or the responsible chief executive, as the case may be, may determine that a qualifying organism is or is contained in a qualifying medicine or a qualifying veterinary medicine only if satisfied that, taking into account all the controls that will be imposed (if any), it is highly improbable that—

  • “(a) the dose and routes of administration of the medicine or veterinary medicine would have significant adverse effects on—

    • “(i) the health of the public; or

    • “(ii) any valued species; and

  • “(b) the qualifying organism could form an undesirable self-sustaining population and would have significant adverse effects on—

    • “(i) the health and safety of the public; or

    • “(ii) any valued species; or

    • “(iii) natural habitats; or

    • “(iv) the environment.

  “(4) In determining under subsection (3) whether a qualifying organism is or is contained in a qualifying medicine or a qualifying veterinary medicine, the following effects (if any) are not to be taken into account:

  • “(a) any effect of the medicine or qualifying organism on the person who is being treated with the medicine:

  • “(b) any effect of the veterinary medicine or qualifying organism on the animal that is being treated with the veterinary medicine.

  “(5) An approval granted under this section is not an approval—

  • “(a) to use a qualifying medicine until the medicine has been lawfully supplied for use under the Medicines Act 1981: or

  • “(b) to use a qualifying veterinary medicine until the veterinary medicine has been approved for use under the Agricultural Compounds and Veterinary Medicines Act 1997.

“38J Procedure for assessing and approving application by responsible chief executive

• If the Authority has delegated to the responsible chief executive its power to assess and approve an application under section 38 for the release of a qualifying organism, the responsible chief executive must—

  • “(a) be paid the fee set by the Authority for the assessment and approval of the application; and

  • “(b) determine whether the medicine is a qualifying medicine or the veterinary medicine is a qualifying veterinary medicine, as the case may be; and

  • “(c) if the responsible chief executive is satisfied that the medicine is a qualifying medicine or the veterinary medicine is a qualifying veterinary medicine, the responsible chief executive may, with or without controls, approve the release of the qualifying organism.

“38K Controls

• “(1) The type of controls that may be imposed on the importation for release or release from containment of a qualifying organism include—

  • “(a) controls for the distribution of the qualifying medicine or qualifying veterinary medicine:

  • “(b) controls providing for the methods of administering the qualifying medicine or qualifying veterinary medicine:

  • “(c) controls concerning the persons who may administer the qualifying medicine or qualifying veterinary medicine:

  • “(d) controls concerning the persons to whom the qualifying medicine may be administered:

  • “(e) controls concerning the animals to which the qualifying veterinary medicine may be administered.

  “(2) Subsection (1) does not limit the type of controls that may be imposed on the importation for release or release from containment of a qualifying organism.

“38L Review of controls for qualifying organisms

• “(1) The Authority may, on its own initiative or on the application of the holder of an approval under section 381 or of any person specified in section 97 or section 97A, review any controls that it has imposed on the approval, but only if—

  • “(a) the review is to amend a control so that it better meets the objective of the control; or

  • “(b) the control included a review requirement specifying—

    • “(i) the circumstances in which the control would be reviewed; and

    • “(ii) the potential consequences of the review.

  “(2) The Authority—

  • “(a) may carry out the review without publicly notifying the review in accordance with section 53; but

  • “(b) if it does so, must—

    • “(i) consult, and consider the views of, any government agency (as defined in section 49A) that the Authority considers is likely to have an interest in the review; and

    • “(ii) publicly notify the results of the review.

  “(3) This section does not limit section 67A.”

• “(2) A decision by the Authority under section 38 or section 38C or section 38I to decline an application does not prevent the Authority from granting an approval to import a new organism into containment, develop a new organism in containment, or field test a new organism in containment for 1 or more of the purposes specified in subsection (1).

• “(3) If an application has been made to the Authority for a conditional release approval, any person may apply to the Authority for approval to put the organism into containment and the application—

  • “(a) must be treated in all respects as an application to import a new organism into containment; and

  • “(b) may be granted only for 1 or more of the purposes specified in subsection (1).

• “(4) If an application has been made to the Authority for an approval under section 38I, any person may apply to the Authority for approval to put the qualifying organism into containment, and the application—

  • “(a) must be treated in all respects as an application to import a new organism into containment; and

  • “(b) may be granted only for 1 or more of the purposes specified in subsection (1).”

“42A Rapid assessment of projects for low-risk genetic modification

• “(1) An application made under section 40 to develop a new organism in containment may, instead of specifying the information required by or under section 40(2), describe—

  • “(a) a project for the development of genetically modified organisms; and

  • “(b) the identity of the host organisms; and

  • “(c) the nature and range of the proposed genetic modifications.

  “(2) After the Authority receives an application under section 40 that complies with subsection (1), the Authority may make a rapid assessment of the adverse effects of carrying out the project if it is satisfied that—

  • “(a) any host organism specified for the project meets the criteria for host organisms prescribed in regulations made under section 41; and

  • “(b) any genetic modification specified for the project meets the criteria for genetic modification procedures prescribed in regulations made under section 41.

  “(3) If the Authority has completed a rapid assessment under subsection (2), the Authority may—

  • “(a) approve the application; and

  • “(b) impose controls providing for each of the matters specified in the Third Schedule as the Authority thinks fit; and

  • “(c) direct the applicant to provide progress reports on the development at the times specified or required by the Authority.

“42B Rapid assessment of adverse effects for importation of genetically modified organisms into containment

• “(1) After the Authority receives an application under section 40 to import a genetically modified organism into containment, the Authority may make a rapid assessment of the adverse effects of importing the organism.

  “(2) If the Authority is satisfied that the importation meets the criteria for a low-risk-genetic modification specified in regulations made under section 41, the Authority may approve the application and impose controls providing for each of the matters specified in the Third Schedule as the Authority thinks fit.

  “(3) Section 25(4) does not apply if an application is approved under this section by a person acting under delegated authority from the Authority under section 19(2)(a).”

“43 Additional matters to be considered when application made for developing new organisms in containment

• The Authority, when making a decision under section 45, must have regard to,—

  • “(a) in the case of an application made under section 40(1)(b) to genetically modify an organism, the matters specified in regulations made under section 41; and

  • “(b) in the case of all applications made under section 40(1)(b), the matters specified in section 37.”

• “(4) In taking into account the adverse effects of the organism under subsection (1)(a)(ii), the Authority must take into account—

  • “(a) the adverse effects (if any) of having the organism and any inseparable organism in containment; and

  • “(b) the probability that the organism may escape after considering all the controls to which the organism would be subject if the application were approved; and

  • “(c) the effects of the organism, if the organism were to escape.”

“45B Animals in circus or zoological garden deemed approved under section 255

• The Authority may, for a deemed approval under section 255,—

  • “(a) include controls that provide for each of the applicable matters specified in the Third Schedule; and

  • “(b) include controls that provide for any other matters in order to give effect to the purpose of this Act; and

  • “(c) remove or vary the conditions imposed under section 255 that the organism remains at a particular place.”

“Rapid assessment and approval of agricultural compounds and medicines in special emergencies

“49A Interpretation

• In sections 49B to 49K,—

  “adverse event includes, but is not limited to, any of the events or emergencies specified in section 46(1)

  “agricultural compound means an agricultural compound (as defined in section 2(1) of the Agricultural Compounds and Veterinary Medicines Act 1997) that is or contains a hazardous substance or a new organism

  “government agency means—

  • “(a) a department specified in the First Schedule of the State Sector Act 1988:

  • “(b) a Crown entity specified in the Fourth Schedule of the Public Finance Act 1989

  “interested government agency means a government agency that, in the opinion of the Authority, is likely to have an interest in the approval of an agricultural compound or medicine in a special emergency

  “medicine means a medicine (as defined in section 3 of the Medicines Act 1981) that is or contains a hazardous substance or new organism

  “responsible Minister means the Minister who, under the authority of any warrant or with the authority of the Prime Minister, is for the time being responsible for the administration of—

  • “(a) this Act; or

  • “(b) the Agricultural Compounds and Veterinary Medicines Act 1997; or

  • “(c) the Biosecurity Act 1993; or

  • “(d) the Conservation Act 1987; or

  • “(e) the Fisheries Act 1996; or

  • “(f) the Health Act 1956; or

  • “(g) the Medicines Act 1981

  “special emergency means a special emergency declared under section 49B.

“49B Declaration of special emergency

• “(1) A responsible Minister may declare an adverse event to be a special emergency if the adverse event is a matter that comes within the Minister's portfolio.

  “(2) A declaration of a special emergency—

  • “(a) must be notified or published in the Gazette as soon as practicable after the special emergency is declared; and

  • “(b) is not a regulation for the purposes of the Acts and Regulations Publication Act 1989.

  “(3) A special emergency expires—

  • “(a) on the close of the date (if any) specified in the declaration as the expiry date; or

  • “(b) if paragraph (a) does not apply, then on the close of a date specified by notice in the Gazette as the date of expiry of the emergency.

“49C Application of sections 49D to 49K

• Sections 49D to 49K apply to a special emergency whether or not—

  • “(a) the special emergency is foreseeable; and

  • “(b) the importation, release, or use of an agricultural compound or medicine in the special emergency is foreseeable.

“49D Application for approval to use agricultural compound or medicine in special emergency

• “(1) A person who does not have approval under this Act to do a thing specified in subsection (2) may apply to the Authority to do the thing in a special emergency.

  “(2) The things are—

  • “(a) import any agricultural compound or medicine for release; or

  • “(b) manufacture an agricultural compound or medicine that is a hazardous substance otherwise in containment; or

  • “(c) release any agricultural compound or medicine from containment; or

  • “(d) use any agricultural compound or medicine in a manner that would contravene this Act or any regulations.

  “(3) For the purposes of subsection (1),—

  • “(a) it does not matter whether the application is made or approved before or after the special emergency has been declared:

  • “(b) the applicant may import, release, or use the agricultural compound or medicine before the declaration of the special emergency has been notified or published in the Gazette.

“49E Contents of application

• “(1) An application under section 49D must be in the approved form and must include information required by the Authority that, having regard to the particular circumstances of the special emergency, the applicant can provide to the Authority in the time available.

  “(2) Without limiting subsection (1), the Authority may require the following information:

  • “(a) information to identify the agricultural compound or medicine and the hazardous substance or new organism that is or is contained in the agricultural compound or medicine; and

  • “(b) information showing that the agricultural compound or medicine is necessary to deal with the special emergency; and

  • “(c) a proposed plan for dealing with the use of the agricultural compound or medicine in the special emergency; and

  • “(d) any reports by experts available from—

    • “(i) the applicant:

    • “(ii) any overseas regulatory agencies; and

  • “(e) written confirmation by the applicant that the agricultural compound or medicine satisfies all relevant manufacturing practices and standards; and

  • “(f) information on whether the agricultural compound or medicine has been approved for use in an overseas country; and

  • “(g) information on whether approval for use of the agricultural compound or medicine has been declined in an overseas country; and

  • “(h) information on the nature of the special emergency; and

  • “(i) information on the nature of the agricultural compound or medicine; and

  • “(j) information on the labelling of the agricultural compound or medicine; and

  • “(k) all other prescribed information (if any).

  “(3) The Authority may, by written notice given to the applicant, require the applicant to verify the application by statutory declaration.

  “(4) An applicant may, by written notice to the Authority, withdraw the application at any time.

“49F Determination of applications

• “(1) As soon as practicable after receiving an application under section 49D, the Authority must complete a rapid assessment of the application and decide whether to approve or decline the application.

  “(2) In determining whether to approve or decline the application, the Authority must—

  • “(a) consult, and have particular regard to the views of, the Department of Conservation; and

  • “(b) consult and consider the views of any other interested government agency; and

  • “(c) consider all the information on the matters specified in section 49E that, having regard to the particular circumstances of the special emergency, the applicant can provide to the Authority in the time available.

  “(3) The Authority may decline the application only if it is satisfied that—

  • “(a) the agricultural compound or medicine is not necessary for use in the special emergency; or

  • “(b) if the application relates to a hazardous substance, the proposed plan does not adequately control the adverse effects of the hazardous substance; or

  • “(c) if the application relates to a new organism, the proposed plan does not adequately control the adverse effects of the new organism or any inseparable organism (including, but not limited to, adequate control of the organism if the organism is likely to establish an undesirable self-sustaining population, taking into account the ease of destroying such a population).

“49G Controls attaching to approval of application

• If the Authority approves an application under section 49F, the Authority must impose the control that the agricultural compound or medicine may be released only if the special emergency is dealt with in accordance with the specified plan, and the plan includes—

  • “(a) the measures that must be taken to avoid, remedy, or mitigate any actual or potential adverse effects from the use of the agricultural compound or medicine:

  • “(b) the requirements for the disposal of the agricultural compound or medicine and any waste products:

  • “(c) the requirements for the eradication or control of any new organism.

“49H Notification or publication of approval of application

• “(1) An approval under section 49F and the reasons for the approval must be notified or published in the Gazette.

  “(2) The notified or published approval—

  • “(a) must describe the special emergency to which it relates; and

  • “(b) must specify where a copy of the plan for dealing with the use of the agricultural compound or medicine in the special emergency may be inspected or obtained; but

  • “(c) need not specify what the approval has been granted for.

  “(3) If the approval is only notified in the Gazette,—

  • “(a) the notice must specify where a copy of the approval may be inspected or obtained; and

  • “(b) the Authority must make copies of the approval available for inspection free of charge, and for purchase at a reasonable cost, at the head office of the Authority and at any other places that the Authority determines as necessary or appropriate.

“49I Effect of approval of release

• “(1) An approval for the importation, release, or use of an agricultural compound or medicine in a special emergency is limited to the importation, release, or use of the agricultural compound or medicine in the special emergency.

  “(2) If an approval relates to a new organism, the organism does not cease to be a new organism because it is released in accordance with the approval.

“49J Duration of approval

• An approval under section 49F takes effect on the day specified in the approval, and expires on the earlier of—

  • “(a) the date of expiry (if any) of the special emergency specified by a responsible Minister in—

    • “(i) the declaration declaring the special emergency; or

    • “(ii) a later declaration declaring that the special emergency has ceased; or

  • “(b) the date of expiry (if any) specified by the Authority in the approval, which must not be later than the date of expiry of the special emergency; or

  • “(c) if paragraph (a) or paragraph (b) does not apply, 2 years after the date on which the approval is granted.

“49K Consequences of expiry of approval

• On the expiry of an approval under section 49F that relates to a hazardous substance or new organism, the hazardous substance or new organism must be disposed of unless, before the expiry of the approval, the applicant has, under any other provision of this Act, been granted an approval.”

• “(2) The Governor-General may, by Order in Council made on the recommendation of the Minister, amend Schedule 2 to—

  • “(a) add a new organism that the Authority has, under subsection (3), recommended to the Minister be included in the schedule:

  • “(b) add a new organism, or group or groups of new organisms, that have adverse effects on the health and safety of people or the environment:

  • “(c) remove an organism or group of organisms, but only if the organism was inserted by Order in Council.

• “(2A) Subsection (2) applies subject to section 141.

• “(2B) An organism in Schedule 2 that is prescribed as not a new organism in regulations made under section 140(1)(ba) is to be treated as if it had been removed from that schedule.”

• “(ab) an application under section 38A for a conditional release approval for a new organism:”.

• “(ii) any local authority (within the meaning of the Local Government Act 2002) if, in the opinion of the Authority, the local authority is likely to have an interest in the application.”

• “(a) any information is held by the Authority relating to any application made under this Act in respect of a hazardous substance or new organism; and”.

• “(a) any information is held by the Authority relating to any application made under this Act in respect of a hazardous substance or new organism; and”.

• “(4) The Authority may release the information or withhold the information in accordance with the Official Information Act 1982 if—

  • “‘(a) the Authority has complied with subsection (2); and

  • “‘(b) the time limit specified in subsection (3) has expired.’”

• “(b) if any of sections 28A, 35, 38I, 42, 42A, or 42B apply to the application,—

  • “(i) make a rapid assessment of the application within 10 working days after receipt of the application; and

  • “(ii) if the application is not approved under one of those sections, publicly notify the application, if required under this Act, within 10 working days of the Authority's decision.”

• “(ca) sections 38A to 38D and 54 to 61 apply with all necessary modifications to a reassessment of a conditional release approval:

• “(cb) sections 38I to 38L and 54 to 58 apply with all necessary modifications to a reassessment of a qualifying organism released with controls:”.

• “(3) However, a reassessment of a qualifying organism released with controls is not required to be publicly notified in accordance with section 53.”

• “(1) The Minister may direct that he or she will decide an application under this Act if the Minister considers that the decision on the application will have—

  • “(a) significant cultural, economic, environmental, ethical, health, international, or spiritual effects; or

  • “(b) significant effects in an area in which the Authority lacks sufficient knowledge or experience.”

• “(4) The Authority—

  • “(a) must hold an inquiry in public; and

  • “(b) must consider—

    • “(i) all matters under this Act relevant to the application; and

    • “(ii) the Minister's reasons for giving the direction under section 68.”

“97A Enforcement of Act in respect of new organisms

• “(1) The enforcement agency must ensure that the provisions of this Act are enforced in respect of new organisms.

  “(2) For the purpose of complying with subsection (1), the enforcement agency may appoint enforcement officers in accordance with this Act who may exercise also the powers of inspectors under the Biosecurity Act 1993 that may be exercised in respect of an unwanted organism, and the provisions of that Act apply with all necessary modifications.

  “(3) A person who may exercise powers under the Biosecurity Act 1993 in respect of unwanted organisms may also exercise those powers under that Act in respect of new organisms whether or not the person is appointed as an enforcement officer under this Act.

  “(4) Without limiting subsection (2), the provisions of the Biosecurity Act 1993 that apply, with all necessary modifications, for the purposes of this section include sections 162A, 163, and 164 of that Act.

  “(5) In this section,—

  “enforcement agency means the chief executive of the department of State responsible for the administration of the Biosecurity Act 1993

  “unwanted organism has the same meaning as in section 2(1) of the Biosecurity Act 1993.”

“98A Chief executives of Ministry and Authority to have functions, powers, duties, and protections of enforcement officers

• “(1) For the purposes of this Act, a chief executive has the same functions, powers, duties, and protections that enforcement officers have under this Act.

  “(2) In subsection (1), chief executive means—

  • “(a) the chief executive of the department of State responsible for the administration of this Act:

  • “(b) the chief executive of the Authority.”

• “(2) The period referred to in paragraph (1)(d) of this section must—

  • “(a) commence at the time the notice is served; and

  • “(b) be reasonable, having regard to the circumstances giving rise to the compliance order.”

• “(6A) To avoid doubt, the Court may make an order under either or both of subsection (5) and subsection (6) against the same person in respect of the same offence.”

“Part 7A
“Pecuniary penalties and civil liability for breaches relating to new organisms

“124A Interpretation

• In this Part, unless the context otherwise requires,—

  “Court means the High Court

  “enforcement agency means the chief executive of the department of State responsible for the administration of the Biosecurity Act 1993.

“Pecuniary penalties

“124B Pecuniary penalty order

• “(1) The enforcement agency may apply to the Court for an order that a person pay to the Crown a pecuniary penalty under this Act.

  “(2) The Court may make the order if it is satisfied that the person—

  • “(a) developed, field tested, imported, or released a new organism in breach of this Act; or

  • “(b) possessed or disposed of any new organism imported, manufactured, developed, or released in breach of this Act; or

  • “(c) failed to comply with any controls relating to a new organism—

    • “(i) imposed by any approval granted under this Act; or

    • “(ii) specified in regulations made under this Act.

  “(3) The Court must not make the order if the person satisfies the Court that the person did not know, and could not reasonably have known, of the breach.

“124C Amount of pecuniary penalty

• “(1) The Court must not make an order for the payment of a pecuniary penalty that exceeds,—

  • “(a) in the case of an individual, $500,000; or

  • “(b) in the case of a body corporate, the greater of—

    • “(i) $10,000,000; or

    • “(ii) if it can be readily ascertained and if the Court is satisfied that the contravention occurred in the course of producing a commercial gain, 3 times the value of any commercial gain resulting from the contravention; or

    • “(iii) if the commercial gain cannot be readily ascertained, 10% of the turnover of the body corporate and all of its interconnected bodies corporate (if any).

  “(2) In determining an appropriate penalty under this section, the Court must have regard to all relevant matters, including—

  • “(a) the nature and extent of the breach:

  • “(b) the nature and extent of any loss or damage suffered by any person or to the environment as a result of the breach:

  • “(c) the circumstances in which the breach took place:

  • “(d) whether or not the person has previously been found in proceedings under this Act to have engaged in any similar conduct:

  • “(e) the steps taken by the person to bring the breach to the attention of the enforcement agency:

  • “(f) the steps taken by the person to avoid, remedy, or mitigate the effects of the breach.

  “(3) In this section, interconnected and turnover have the same meaning as in the Commerce Act 1986.

“124D Other orders instead of or in addition to pecuniary penalty order

• “(1) At the conclusion of proceedings for an order for the payment of a pecuniary penalty under section 124B, the Court may, instead of or in addition to making the order, make—

  • “(a) an order that the person mitigate or remedy any adverse effects on people or the environment—

    • “(i) caused by or on behalf of the person; or

    • “(ii) relating to any land that the person owns or occupies; or

  • “(b) an order to pay the costs of mitigating or remedying the adverse effects specified in paragraph (a).

  “(2) At the conclusion of proceedings for an order for the payment of a pecuniary penalty under section 124B the Court may, instead of or in addition to making the order, make an order for the destruction of the new organism involved in the breach.

  “(3) To avoid doubt, the Court may make an order under either or both of subsections (1) and (2) against the same person in respect of the same breach.

“124E Standard of proof and procedural matters

• In proceedings for an order under section 124B,—

  • “(a) the standard of proof is the standard of proof that applies in civil proceedings; and

  • “(b) the enforcement agency may, by order of the Court, obtain discovery and administer interrogatories.

“124F Relationship between concurrent proceedings for pecuniary penalty and criminal proceedings

• “(1) Criminal proceedings under this Act may be started against a person whether or not proceedings for an order under section 124B have been started against the person for the same act or omission or substantially the same act or omission in respect of which the criminal proceedings have been started.

  “(2) Uncompleted proceedings for an order under section 124B must be stayed if criminal proceedings are started or have already been started against the person for the same act or omission or substantially the same act or omission in respect of which the order is sought.

“Civil liability for acts and omissions while in breach

“124G Civil liability

• “(1) A person is liable in damages for any loss or damage caused by any act or omission of the person while—

  • “(a) developing, field testing, importing, or releasing a new organism in breach of this Act:

  • “(b) possessing or disposing of any new organism imported, manufactured, developed, or released in breach of this Act; or

  • “(c) failing to comply with any controls relating to a new organism—

    • “(i) imposed by any approval granted under this Act; or

    • “(ii) specified in any regulations made under this Act.

  “(2) A person is liable under subsection (1) whether or not—

  • “(a) the person intended the act, omission, or breach; or

  • “(b) the person was taking reasonable care when the act, omission, or breach occurred.

  “(3) To avoid doubt, proceedings under this section are in addition to, and not in substitution for, any other cause of action.

“124H Defences to liability under section 124G

• “(1) A person is not liable under section 124G if the person proves 1 or more of the defences specified in subsection (2) in relation to the breach.

  “(2) The defences are—

  • “(a) that—

    • “(i) the breach was necessary for the purpose of—

      • “(A) saving or protecting life or health; or

      • “(B) preventing serious damage to property; or

      • “(C) avoiding an actual or likely adverse effect on the environment; and

    • “(ii) the conduct of the defendant was reasonable in the circumstances; and

    • “(iii) the defendant took steps that were reasonable in all the circumstances to mitigate or remedy the effects of the breach after it occurred; or

  • “(b) that the breach was due to an event beyond the control of the defendant (including natural disaster, mechanical failure, or sabotage) and—

    • “(i) the event could not reasonably have been foreseen or been provided against by the defendant; and

    • “(ii) the defendant took steps that were reasonable in all the circumstances to mitigate or remedy the effects of the breach after the event occurred; or

  • “(c) that the defendant did not know, and could not reasonably have known, of the breach.

“Liability for acts and omissions of others

“124I Breaches, acts, and omissions by directors, employees, or agents

• “(1) This section applies for the purposes of sections 124B and 124G

  “(2) A body corporate is to be treated as in breach of this Act or as having done or omitted to do an act if—

  • “(a) a director, employee, or agent of the body corporate, acting within the scope of his or her actual or apparent authority, is in breach of this Act or has done or omitted to do an act; or

  • “(b) any other person, at the direction or with the consent or agreement (whether express or implied) of a director, employee, or agent of the body corporate, given within the scope of the actual or apparent authority of the director, employee, or agent, is in breach of this Act or has done or omitted to do an act.

  “(3) A person (person A) who is not a body corporate is to be treated as in breach of this Act or as having done or omitted to do an act if—

  • “(a) an employee or agent of person A, acting within the scope of his or her actual or apparent authority, is in breach of this Act or has done or omitted to do an act; or

  • “(b) any other person, at the direction or with the consent or agreement (whether express or implied) of an employee or agent of person A, given within the scope of the actual or apparent authority of the employee or agent, is in breach of this Act or has done or omitted to do an act.

  “(4) If a person in breach of this Act has a defence to the breach under section 124H, the defence is also available to another person if the breach is to be treated under subsection (2) or subsection (3) as also the breach of the other person.

  “(5) However, the defence under section 124H(2)(c) is not available to the other person unless the other person also proves that he or she did not know, and could not reasonably have known, of the breach by the person.

  “(6) If the Court is prevented by section 124B(3) from making an order under that section against a person in breach of this Act and the breach is to be treated under subsection (2) or subsection (3) of this section as also the breach of another person, the Court must not make an order under section 124B against the other person if it is satisfied that the other person did not know and could not reasonably have known of the breach.”

• “(ba) prescribing organisms that are not new organisms for the purposes of this Act:”.

• “(fa) prescribing controls for any conditionally released new organism or any qualifying organism released with controls, to avoid or mitigate any adverse effects on the physical or chemical nature of the environment:

• “(fb) prescribing controls for any conditionally released new organism or any qualifying organism released with controls, to avoid or mitigate illness or injury to people or animals (other than the persons or animals referred to in section 38I(4)(a) and (b)) or damage to the environment or chattels:”.

• “(2A) Regulations may be made under subsection (1)(ba) only if the Minister has considered—

  • “(a) whether the organism has formed a self-sustaining population in New Zealand; and

  • “(b) whether any person is attempting to manage, control, or eradicate the organism under any Act.”