(1) In this Act, unless the context otherwise requires,—

(2) For the purposes of paragraph (a) of the definition of the term substance in section 2(1) of this Act, the definition of any mixture of elements or mixture of compounds may include a range of percentages of the elements or compounds making up the substance.

(1) A new organism is—

• (a) An organism belonging to a species that was not present in New Zealand immediately before 29 July 1998:

• (b) An organism belonging to a species, subspecies, infrasubspecies, variety, strain, or cultivar prescribed as a risk species, where that organism was not present in New Zealand at the time of promulgation of the relevant regulation:

• (c) An organism for which a containment approval has been given under this Act:

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

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

• (d) A genetically modified organism:

• (e) An organism that belongs to a species, subspecies, infrasubspecies, variety, strain, or cultivar that has been eradicated from New Zealand.

(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; or

• (c) it is an incidentally imported new organism.

(3) Despite the provisions of this section, an organism present in New Zealand before 29 July 1998 in contravention of the Animals Act 1967 or the Plants Act 1970 is a new organism.

(4) Subsection (3) does not apply to the organism known as rabbit haemorrhagic disease virus, or rabbit calicivirus.

(1) Except as provided in subsections (2) to (8) of this section, this Act shall bind the Crown.

(2) Subject to subsections (3) to (8) of this section, this Act shall not apply to any hazardous substance controlled by the Minister of Defence.

(3) The Chief of Defence Force shall develop codes of practice for hazardous substances controlled by the Minister of Defence and contained in any weapons system.

(4) The codes of practice developed under subsection (3)—

• (a) must—

  • (i) be based on the relevant controls (including any group standard conditions) imposed by the Authority on hazardous substances that have been approved by the Authority (including a deemed approval under section 96E or section 160A) for any purpose under this Act; or

  • (ii) meet the relevant requirements prescribed by regulations made in accordance with section 75; and

• (b) may incorporate or adapt any relevant international code of practice.

(5) The Chief of Defence Force—

• (a) must ensure that methods of controlling all hazardous substances not contained in any weapons system and controlled by the Minister of Defence—

  • (i) are based on the relevant controls (including any group standard conditions) imposed by the Authority on hazardous substances that have been approved by the Authority (including a deemed approval under section 96E or section 160A) for any purpose under this Act; or

  • (ii) meet the relevant requirements prescribed by regulations made in accordance with section 75; and

• (b) may comply with the relevant requirements in paragraph (a) by following the relevant code of practice approved under section 79.

(6) The Secretary of Defence shall audit the controls on hazardous substances under the control of the Minister of Defence in accordance with section 24(2)(e) of the Defence Act 1990, and report the results to the Minister and the Minister of Defence.

(7) Any person may report to the Authority a breach of the requirements required to be met by any regulations in relation to hazardous substances under the control of the Minister of Defence.

(8) Where an incident occurs which involves any hazardous substance under the control of the Minister of Defence and the incident is not being investigated under the Armed Forces Discipline Act 1971, the Authority may, after consultation with the Minister and the Minister of the Crown who is responsible for the Ministry of Justice, direct an inquiry to be held before a District Court Judge.

(9) To assist the Judge, the Authority may appoint 2 or more people with skills or knowledge relevant to the subject-matter of the inquiry.

(10) The Judge may hold the inquiry at any times and places the Judge appoints, and shall report on the cause of the incident to the Authority.

(11) The Judge has all the powers of a Commission of Inquiry under the Commissions of Inquiry Act 1908; and subject to subsections (9) and (10) of this section, that Act shall apply accordingly.

The purpose of this Act is to protect the environment, and the health and safety of people and communities, by preventing or managing the adverse effects of hazardous substances and new organisms.

All persons exercising functions, powers, and duties under this Act shall, to achieve the purpose of this Act, recognise and provide for the following principles:

• (a) The safeguarding of the life-supporting capacity of air, water, soil, and ecosystems:

• (b) The maintenance and enhancement of the capacity of people and communities to provide for their own economic, social, and cultural wellbeing and for the reasonably foreseeable needs of future generations.

All persons exercising functions, powers, and duties under this Act shall, to achieve the purpose of this Act, take into account the following matters:

• (a) The sustainability of all native and valued introduced flora and fauna:

• (b) The intrinsic value of ecosystems:

• (c) Public health:

• (d) The relationship of Maori and their culture and traditions with their ancestral lands, water, sites, waahi tapu, valued flora and fauna, and other taonga:

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

• (f) New Zealand's international obligations.

All persons exercising functions, powers, and duties under this Act, including but not limited to, functions, powers, and duties under sections 28A, 29, 32, 38, 45, and 48 of this Act, shall take into account the need for caution in managing adverse effects where there is scientific and technical uncertainty about those effects.

All persons exercising powers and functions under this Act shall take into account the principles of the Treaty of Waitangi (Te Tiriti o Waitangi).

(1) The Governor-General may from time to time, by Order in Council, establish a methodology (which includes an assessment of monetary and non-monetary costs and benefits) for making decisions under Part 5 of this Act; and the Authority shall consistently apply that methodology when making such decisions.

(2) Before making any recommendation for the purpose of making any Order in Council under subsection (1) of this section, the Minister shall request the Authority to—

• (a) Develop a proposed methodology; and

• (b) Establish a process that the Minister considers gives the public adequate time and opportunity to make submissions on the proposed methodology to the Authority; and

• (c) Advise the Minister of any submissions received, and any comments the Authority wishes to make on the submissions, or the proposed methodology,—

and the Minister shall have regard to those submissions and comments.

(3) A failure to comply with subsection (2) of this section shall not affect the validity of any Order in Council made under subsection (1) of this section.

(4) Notwithstanding section 59 of this Act, the Authority shall not proceed to determine any application made under Part 5 of this Act until an Order in Council has been made under subsection (1) of this section.

(5) No decision of the Authority under Part 5 of this Act shall be challenged on the adequacy or otherwise of the methodology developed and applied under subsection (1) of this section.

(1) The Minister may—

• (a) [Repealed]

• (b) [Repealed]

• (c) Decide any application made under this Act in accordance with the provisions of sections 68 to 73 inclusive of this Act:

• (d) Carry out any powers, functions, and duties conferred on the Minister by or under this Act.

(2) Subsection (1)(c) and (d) apply despite section 113 of the Crown Entities Act 2004.

(3) This section does not limit section 27 of the Crown Entities Act 2004.

(1) The Authority may—

• (a) Advise the Minister on any matter relating to the purpose of this Act, including, but not limited to,—

  • (i) The extent to which persons are complying with the provisions of this Act:

  • (ii) Inconsistencies or conflicts between any controls placed on hazardous substances and new organisms under this Act and any controls placed on any hazardous substance and new organisms under any other Act:

  • (iii) The consideration and investigation of the use of environmental user charges in accordance with section 96 of this Act:

• (b) Monitor and review—

  • (i) The extent to which the Act reduces adverse effects on the environment or people from hazardous substances or new organisms:

  • (ii) The enforcement of this Act including, but not limited to, the exercise of any power under section 103 of this Act by any enforcement officer:

• (c) Promote awareness of the adverse effects of hazardous substances and new organisms on people or the environment and awareness of the prevention or safe management of those effects:

• (d) Contribute to and cooperate with international forums and carry out international requirements as directed by the Minister:

• (e) Enquire into any incident or emergency involving a hazardous substance or a new organism:

• (f) Keep such registers relating to hazardous substances and new organisms as may be required by this Act or as may be necessary to administer this Act:

• (fa) approve forms for applications under Part 5:

• (fb) give directions as to the disposal of persistent organic pollutants:

• (fc) approve standards for containment facilities:

• (g) Carry out any powers, functions, and duties conferred on it by or under this Act or any other enactment.

(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.

(3) This section does not limit section 17 of the Crown Entities Act 2004.

Any enforcement officer may, in relation to the powers, functions, and duties specified in the enforcement officer's warrant of appointment,—

• (a) Give advice and information on the provisions of this Act:

• (b) Promote and monitor compliance with the provisions of this Act:

• (c) Provide information to the Authority if requested to do so by the Authority:

• (d) Carry out any powers, functions, and duties conferred on enforcement officers by or under this Act.

(1) Every person who imports, possesses, or uses a hazardous substance or new organism shall ensure that—

• (a) Any adverse effect caused by an act or omission of that person in relation to that substance or organism on any other person or the environment is avoided, remedied, or mitigated; and

• (b) No action or omission by that person will contravene any requirement or control on that substance or organism imposed by this Act.

(2) The duty imposed in accordance with subsection (1) of this section is not of itself enforceable against any person, and no person is liable to any other person for a breach of that duty.

(3) Notwithstanding subsection (2) of this section, a compliance order may be served on any person requiring that person to cease or prohibiting that person from commencing anything done or to be done by or on behalf of that person that in the opinion of the enforcement officer relates to any hazardous substance or new organism and is or is likely to be dangerous to such an extent that it has or is likely to have an adverse effect on the health and safety of people or the environment.

(1) There is hereby established an Authority to be called the Environmental Risk Management Authority.

(2) The Authority is a Crown entity for the purposes of section 7 of the Crown Entities Act 2004.

(3) The Crown Entities Act 2004 applies to the Authority except to the extent that this Act expressly provides otherwise.

(1) The Authority must have no fewer than 6, and no more than 8, members.

(2) Members of the Authority are the board for the purposes of the Crown Entities Act 2004.

(3) Members of the Authority hold office for 5 years or any shorter period stated in the notice of appointment.

(4) Subsection (3) applies despite section 32(1)(a) of the Crown Entities Act 2004.

(1) When considering whether a person is suitable to be appointed as a member of the Authority, the Minister shall ensure that the membership includes a balanced mix of knowledge and experience in matters likely to come before the Authority.

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

(3) Subsection (1) does not limit section 29 of the Crown Entities Act 2004.

The Minister may not give a direction under section 104 of the Crown Entities Act 2004 that relates to the exercise of any power, duty, or function of the Authority under Part 5 or Part 6A of this Act.

The provisions set out in Schedule 1 to this Act shall apply in respect of the Authority.

(1) The Authority may, in writing, delegate to any person, any of the Authority's functions, powers, or duties under this Act, on such conditions as the Authority thinks fit, except—

• (a) The fixing of charges under section 21 of this Act; and

• (b) Except as provided in subsection (2) of this section, any decision making power; and

• (c) This power of delegation.

(2) The Authority may delegate, on such terms and conditions as the Authority thinks fit,—

• (a) The power to conduct a rapid assessment under any of sections 35, 42, 42A, or 42B to any person, whether or not that person is a member of the Authority:

• (b) The power to hear and decide any other application made under Part 5 or Part 6A of this Act to any committee appointed for that purpose in accordance with Schedule 1 to this Act.

• (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:

• (c) the power to decide any application for permission or other matter under Parts 11 to 16 to—

  • (i) any employee of the Ministry of Agriculture and Forestry, or of any person specified in section 97, with relevant experience in the subject matter of the application; or

  • (ii) if there is no employee with that relevant experience, any other person with that relevant experience, whether or not that person is a member of the Authority:

• (ca) the power to grant an extension of an exemption under section 25C(2) to—

  • (i) any employee of a person specified in section 97 with relevant experience; or

  • (ii) if there is no employee with relevant experience, any other person with relevant experience, whether or not that person is a member of the Authority:

• (d) the power to conduct a rapid assessment under section 28A to its chief executive:

• (e) the power to hear and decide any application made under section 31 to its chief executive:

• (f) the power to hear and decide an application made under section 83 for approval as a test certifier to any person, whether or not that person is a member of the Authority:

• (g) the power to appoint an enforcement officer under section 99(3)(a) to its chief executive:

• (h) the power to decide any application for any permission or licence under Part 6, or the revocation of any permission or licence under that Part, to—

  • (i) any employee of the Ministry of Agriculture and Forestry, any Medical Officer of Health (as defined in section 2(1) of the Health Act 1956), or any employee of any person specified in section 97, or any enforcement officer, with relevant experience in the subject matter of the application or the permission or licence; or

  • (ii) if there is no employee or enforcement officer with the relevant experience, any other person with the relevant experience, whether or not that person is a member of the Authority:

• (ha) the power to revoke a test certificate for an approved filler or an approved handler under section 82C to its chief executive:

• (i) the power to decide any application for any licence under Part 6, or the revocation of any licence under that Part, to any test certifier approved under section 84.

(3) Every decision made in accordance with a delegation under subsection (2) of this section shall be treated in all respects as though it were a decision of the Authority.

(4) Every person purporting to act under a delegation under this section is presumed to be acting in accordance with its terms in the absence of evidence to the contrary.

(5) A delegation under this section shall be revocable at will, and no such delegation shall prevent the performance or exercise of any function, power, or duty by the Authority.

(5A) A delegate to whom any function or power is delegated under this section may delegate the function or power only—

• (a) with the prior written consent of the Authority; and

• (b) subject to the same restrictions, and with the same effect, as if the subdelegate were the delegate.

(6) Every delegation under subsection (2) must be available for public inspection at the office of the Authority during ordinary office hours.

(7) Sections 73 to 76 of the Crown Entities Act 2004 do not apply to the Authority.

(1) The Authority shall keep a register of all applications made to the Authority.

(2) The register shall specify—

• (a) The name and address of the applicant:

• (b) A sufficient description of the substance or organism to uniquely identify that substance or organism:

• (c) The purpose of the application:

• (ca) if applicable, the project concerned:

• (d) Whether the application was approved or declined:

• (e) Any controls attached to the approval by the Authority, including any associated permissions granted under section 95A and any associated licences granted under section 95B:

• (f) All the controls on a hazardous substance, whether the controls are imposed under this Act or any other Act.

(3) The register shall also record the details of any list of low risk organisms issued by the Authority.

(4) Any decision by the Authority to approve the importation for release or development of any organism as a low risk organism (other than an organism which is listed as a low risk organism), shall also be included in the register.

(5) Every person shall have the right to inspect the register during the ordinary office hours of the Authority.

(1) The Authority must keep and maintain a register of all exposure limits set under this Act for substances with toxic or ecotoxic properties.

(2) The register must specify—

• (a) the type of exposure limit:

• (b) the value of the exposure limit:

• (c) the hazardous substance that the exposure limit will apply to:

• (d) if the exposure limit applies to any element or compound making up the hazardous substance, the element or compound that the exposure limit will apply to.

(3) Every person has the right to inspect the register during the ordinary office hours of the Authority.

(1) The Authority may from time to time—

• (a) Fix the charges—

  • (i) On a scale of charges for exercising or performing any function, power, or duty under this Act; or

  • (ii) Based on the time involved in exercising or performing any function, power, or duty under this Act—

  so as to recover the actual and reasonable costs incurred in the exercise of that function, power, or duty; and

• (b) Specify the persons liable to pay the charge.

(2) Before any charges are fixed pursuant to subsection (1) of this section, the Authority shall—

• (a) Publicly notify the charges it proposes to fix and the persons who are liable to pay the charge; and

• (b) Allow such period of time as the Authority thinks fit for any person who may be liable to pay the proposed charge to comment in writing to the Authority on whether or not the proposed charges are reasonable; and

• (c) Consider any comments received in accordance with paragraph (b) of this subsection.

(3) The Authority shall, after fixing any charges in accordance with this section, publicly notify the charges.

(4) Where the Authority fixes a scale of charges or a charge based on time, the Authority shall provide an estimate of the full charge payable by any person upon request by that person.

(5) Any charge payable under this section by any person in respect of the completed exercise or performance of any function, power, or duty by the Authority shall, until paid in full and remitted to the Authority, constitute a debt due to the Authority, and may be recovered in any Court of competent jurisdiction.

(1) The Authority may estimate the charge payable in respect of the exercise or performance of any function, power, or duty and require that estimated charge or part of that estimated charge to be paid in full before the Authority exercises or performs the function, power, or duty to which that charge relates.

(2) Where the actual and reasonable costs of exercising or performing any function, power, or duty,—

• (a) Exceed the amount paid in advance, the difference between the amount paid and the actual and reasonable costs shall be a debt and the provisions of section 21(5) of this Act shall apply:

• (b) Are less than the amount paid in advance, the Authority shall refund the difference between the amount paid and the actual and reasonable costs.

Any local authority may prescribe fees by bylaw or resolution in accordance with section 150 of the Local Government Act 2002 for the exercise or performance by the local authority of any power, function, or duty under this Act.

The Authority may from time to time request any person who in the Authority's opinion is able to give any information relating to any significant incident or emergency or likely significant incident or emergency involving a hazardous substance or new organism which is the subject of an inquiry by the Authority under section 11(e) of this Act, to furnish to the Authority any such information and to produce any documents or papers or things which in the Authority's opinion relate to any such matter and which may be in the possession or under the control of that person.

This section establishes a committee to be called 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.

(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.

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

(1) No—

• (a) Hazardous substance shall be imported, or manufactured:

• (b) New organism shall be imported, developed, field tested, or released—

otherwise than in accordance with an approval issued under this Act or in accordance with Parts 11 to 16 of this Act.

(1A) Subsection (1)(b) does not apply to—

• (a) the importation of an incidentally imported new organism, if it is imported in or on goods lawfully imported under the Biosecurity Act 1993; or

• (b) the movement or use of those goods, together with any new organisms incidentally imported while they remain in or on those goods, after their importation.

(1B) The department responsible for administering the Biosecurity Act 1993 or its agents, and any other departments recognised by the responsible Minister under section 101(2) of that Act or their agents may, despite subsection (1)(b), isolate, aggregate, multiply, or use an incidentally imported new organism for the purpose of identifying, managing, or eradicating that organism.

(2) No approval shall be issued to import, develop, field test, or release any new organism specified in Schedule 2.

(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 restriction 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,—

(1) No persistent organic pollutant is to be imported or manufactured, and no approval is to be issued to import or manufacture a persistent organic pollutant, except as provided by—

• (a) section 29B; or

• (b) section 30(a); or

• (c) section 30(ba), but only for research in a laboratory.

(2) A persistent organic pollutant that is manufactured in New Zealand must not be used in New Zealand except for a use specified in Schedule 2A for the persistent organic pollutant.

(1) A persistent organic pollutant must not be stored in New Zealand.

(2) However, subsection (1) does not apply to—

• (a) a persistent organic pollutant stored in accordance with conditions specified by the Authority by notice in the Gazette ; or

• (b) a persistent organic pollutant in respect of which storage is specified in Schedule 2A.

(1) For the purposes of sections 25A and 25B and Schedule 2A, an exemption granted under regulation 49I or regulation 49J of the Toxic Substances Regulations 1983 that is in force immediately before the commencement of the Hazardous Substances and New Organisms (Stockholm Convention) Amendment Act 2003 continues—

• (a) on the same terms and conditions as in force at that time; and

• (b) until the expiry of—

  • (i) the exemption; or

  • (ii) an extension of the exemption (being not later than the close of 2016).

(2) The Authority may grant an extension of an exemption for the purposes of subsection (1)(b)(ii).

(1) This section applies to persistent organic pollutants imported or manufactured before the commencement of the Hazardous Substances and New Organisms (Stockholm Convention) Amendment Act 2003.

(2) No person may use a persistent organic pollutant for a use not specified in Schedule 2A if the Authority has issued a direction, by notice in the Gazette, restricting the use of the persistent organic pollutant to the use in that schedule for the persistent organic pollutant.

(3) This section does not prevent approvals being granted under—

• (a) section 30(a); and

• (b) section 30(ba), but only for research in a laboratory.

(1) The Authority may, by notice in the Gazette, on application by any person, determine whether or not any organism is a new organism, or (without limiting any regulations made under section 74(b)) whether or not any substance is a hazardous substance.

(2) Before issuing such a determination, the Authority shall have regard to—

• (a) Any information held by the Authority; and

• (b) Any information held by any department listed in Schedule 1 to the State Sector Act 1988 and any Crown entity; and

• (c) Any information provided by the applicant.

(3) Any determination issued by the Authority under subsection (1) of this section may be revoked or reissued on receipt of further information by the Authority.

In this Act, the term approval means any of the following:

• (a) An approval to import or manufacture a hazardous substance for release:

• (b) An approval to import for release or release from containment any new organism:

• (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:

• (c) An approval to import any new organism into containment, field test any new organism in containment, develop any new organism in containment:

• (d) An approval to import any hazardous substance into containment or manufacture any hazardous substance in containment:

• (e) An approval to import or manufacture any hazardous substance for release in an emergency, import any new organism for release in an emergency, or release any new organism from containment in an emergency:

• (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.

(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.

(1) Unless an approval under section 28A or section 29 applies to the importation or manufacture of the substance, every person intending to—

• (a) Import; or

• (b) Manufacture—

a hazardous substance otherwise than in containment shall, before importation or manufacture, apply to the Authority for approval to import or manufacture that substance.

(2) Every application shall be in an approved form and shall include—

• (a) The unequivocal identification of the substance and its properties; and

• (b) Information on all the possible adverse effects of the substance on the environment; and

• (c) Information on the intended uses of the substance throughout the life cycle of the substance; and

• (d) Information on methods for disposal of the substance; and

• (e) Information on all occasions where the substance has been considered by the government of any prescribed State or country or any prescribed organisation and the results of such consideration; and

• (f) Such other information as may be prescribed.

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

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

(1) When the Authority receives an application under section 28 in respect of a hazardous substance, and the applicant has verified the information contained in the application by statutory declaration, the Authority may make a rapid assessment of the adverse effects of importing or manufacturing the substance.

(2) The Authority may approve a hazardous substance under this section if the Authority is satisfied that—

• (a) a substance having a similar composition and similar hazardous properties has been approved; or

• (b) the substance has one or more hazardous properties and each hazardous property has the least degree of hazard for that property; or

• (c) the substance has been formulated so that 1 or more of its hazardous properties has a lesser degree of hazard than any substance that has been approved under this Act.

(3) Sections 77, 77A, and 77B apply to a hazardous substance approved by the Authority under this section as if the approval had been given under section 29.

(4) If the Authority does not approve a hazardous substance under this section the application under section 28 may be determined under section 29.

(1) After considering any application for approval made under section 28 of this Act the Authority may, in its discretion,—

• (a) Approve the application if, after taking into account—

  • (i) Any controls which may be imposed on the substance; and

  • (ii) All effects of the substance during the lifecycle of that substance; and

  • (iii) The likely effects of the substance being unavailable,—

  the positive effects of the substance outweigh the adverse effects; or

• (b) Decline the application if, after taking into account—

  • (i) Any controls which may be imposed on the substance; and

  • (ii) All effects of the substance during the lifecycle of that substance; and

  • (iii) The likely effects of the substance being unavailable,—

  the adverse effects of the substance outweigh the positive effects; or

• (c) Decline the application if insufficient information is available to enable the Authority to determine the adverse effects of the substance.

(2) The provisions of sections 77, 77A, and 77B of this Act shall apply to any substance approved by the Authority under subsection (1) of this section.

(3) The Authority shall give its decision in writing, including reasons for the decision, give written notice of the decision to the applicant and every person who made a submission, and publicly notify it.

(1) An application to import a persistent organic pollutant may be granted,—

• (a) if a use for the persistent organic pollutant is specified in Schedule 2A, only for that use; or

• (b) if no use for the persistent organic pollutant is specified in Schedule 2A, only for the purpose of environmentally sound disposal.

(2) An application to manufacture a persistent organic pollutant may be granted if manufacture for the persistent organic pollutant is specified in Schedule 2A.

The Authority may approve the manufacture or importation of any hazardous substance in containment for any of the following purposes:

• (a) small amounts of any hazardous substance for use as analytical standards where—

  • (i) approval to import or manufacture that substance has been declined; or

  • (ii) the substance is a persistent organic pollutant; or.

• (b) Research on any hazardous substance to acquire information for use in assessing that substance in accordance with this Part of this Act; or

• (ba) research and development on any hazardous substance; or

• (c) Use in an emergency under this or any other Act; or

• (ca) formulating, relabelling, repackaging, or storing any hazardous substance for export to a destination outside New Zealand; or

• (d) Such other purposes as the Authority thinks fit.

(1) Every person intending—

• (a) To import into containment; or

• (b) Manufacture in containment—

any hazardous substance shall, before importation or manufacture, apply to the Authority for approval to import or manufacture that substance.

(2) Every application shall be in an approved form and shall include—

• (a) Identification of the substance for which approval is sought:

• (b) The purpose for which approval is sought:

• (c) The quantity of the substance proposed to be imported or manufactured:

• (d) Information on all occasions where the substance has been considered by the government of any prescribed State or country or any prescribed organisation and the results of such consideration:

• (e) Such other information as may be prescribed:

• (f) All information known to the applicant relating to the effects of the substance throughout the lifecycle of the substance:

• (g) Information on the proposed containment system.

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

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

(1) After considering any application for approval made under section 31 of this Act, the Authority may grant the application if the application is for one of the purposes specified in section 30 of this Act and the Authority is satisfied that the substance can be adequately contained.

(2) An approval under this section—

• (a) must include controls that provide for each of the applicable matters specified in Schedule 3; and

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

(3) The Authority shall give its decision, in writing, including reasons for the decision, give written notice of the decision to the applicant and every person who made a submission, and publicly notify it.

(1) Nothing in this Act applies to any small-scale use of hazardous substances in research and development or teaching if—

• (a) the use occurs in a laboratory that meets the prescribed requirements; and

• (b) the use does not create or involve a hazardous substance for which any application for approval has been declined under this Act; and

• (ba) the use does not create or involve a persistent organic pollutant; and.

• (c) the importation, storage, and transportation of the hazardous substances each meets the prescribed requirements; and

• (d) No such hazardous substance, nor any substance created from that use, is sold as a substance or in a product containing or derived from that substance, except as provided for in subsection (2).

(2) A hazardous substance, or any substance created from the use of that hazardous substance, referred to in subsection (1) may be sold as a substance or in a product containing or derived from that substance only if it is sold to—

• (a) a laboratory in New Zealand that meets the prescribed requirements:

• (b) a laboratory outside New Zealand, but only if—

  • (i) the hazardous substance or the substance has been sold to the laboratory outside New Zealand by a laboratory in New Zealand that meets the prescribed requirements; and

  • (ii) the laboratory in New Zealand holds evidence that the hazardous substance or the substance will be used by the laboratory outside New Zealand in research and development or training, and produces that evidence if requested to do so by the Authority.

(1) Every person intending—

• (a) To import for release; or

• (b) To release from containment—

any new organism shall, before importation or release, apply, under this section or under section 38A, to the Authority for approval to import or release.

(2) Every application under this section shall be in an approved form and shall include—

• (a) Any information prescribed; 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 such 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 potential use for the organism.

(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.

(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.

(1) Where the Authority receives an application under section 34 of this Act to import a new organism that is not a genetically modified organism for release, the Authority may make a rapid assessment of the adverse effects of importing that organism in accordance with subsections (2) and (3) of this section.

(2) If the Authority is satisfied that—

• (a) The organism is not an unwanted organism as defined in the Biosecurity Act 1993; and

• (b) It is highly improbable that the organism, after release,—

  • (i) Could form self-sustaining populations anywhere in New Zealand, taking into account the ease of eradication; or

  • (ii) Could displace or reduce a valued species; or

  • (iii) Could cause deterioration of natural habitats; or

  • (iv) Will be disease-causing or be a parasite, or be a vector or reservoir for human, plant, or animal disease; or

  • (v) Will have any adverse effects on human health and safety or the environment,—

  the Authority may approve the application without controls.

(3) If the Authority is satisfied that—

• (a) The organism is an unwanted organism as defined in the Biosecurity Act 1993; or

• (b) The organism is likely to fail the minimum standards specified in section 36 of this Act—

the Authority may, subject to subsection (5) of this section, decline the application.

(4) If the Authority considers that the application should not be approved under subsection (2) of this section, then the application may be determined under section 38 of this Act.

(5) Where any person appointed by the Authority to conduct a rapid assessment of risk declines an application under subsection (3) of this section, the applicant may request the Authority to continue the assessment and determine the application in accordance with section 38 of this Act.

The Authority shall decline the application, if the new organism is likely to—

• (a) Cause any significant displacement of any native species within its natural habitat; or

• (b) Cause any significant deterioration of natural habitats; or

• (c) Cause any significant adverse effects on human health and safety; or

• (d) Cause any significant adverse effect to New Zealand's inherent genetic diversity; or

• (e) Cause disease, be parasitic, or become a vector for human, animal, or plant disease, unless the purpose of that importation or release is to import or release an organism to cause disease, be a parasite, or a vector for disease.

The Authority, when making a decision under section 38 of this Act, shall have regard to—

• (a) The ability of the organism to establish an undesirable self-sustaining population; and

• (b) The ease with which the organism could be eradicated if it established an undesirable self-sustaining population.

(1) If an application made under section 34 of this Act is not granted under section 35 or any other section, the Authority may, in its discretion,—

• (a) Approve the application if—

  • (i) The organism meets the minimum standards set out in section 36 of this Act; and

  • (ii) After taking into account all the effects of the organism, the effects of any inseparable organism and the matters in section 37 of this Act, the positive effects of the organism outweigh the adverse effects of the organism and any inseparable organism; or

• (b) Decline the application if—

  • (i) The organism fails to meet the said minimum standards; or

  • (ii) After taking into account all the effects of the organism, the effects of any inseparable organism, and the matters in section 37 of this Act, the adverse effects of the organism and any inseparable organism outweigh the positive effects; or

  • (iii) Insufficient information is available to enable the Authority to assess the adverse effects of the organism.

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

(3) Any approval to import an organism for release or to release an organism from containment shall lapse 5 years after the date of the approval unless—

• (a) The organism is sooner released; or

• (b) The Authority, following an application by any person before the expiry of the time limit, extends the time limit for a further period of up to 5 years.

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

(4) Every person who releases an organism in accordance with an approval given under this section within 5 years after the date of that approval shall, unless the requirement is waived by the Authority, notify the Authority within one month after the date of release.

(5) The Authority shall give its decision in writing, including reasons for the decision, give written notice of the decision to the applicant and every person who made a submission, and publicly notify it.

(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.

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.

(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.

(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.

(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.

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.

(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.

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.

(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.

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.

(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.

(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.

(1) The Authority may approve the importation, development, or field testing of any new organism into containment for the following purposes:

• (a) The development of any new organism:

• (b) Field testing any new organism:

• (c) Maintaining a new organism for use in an emergency (as defined in section 46 of this Act):

• (d) The conservation of any genetic material:

• (e) The public display of any organism including, but not limited to, display in a circus or zoological garden:

• (f) Maintaining a new organism in containment to produce antigens, biopesticides, biopharmaceuticals, enzymes, hormones, or vaccines for release:

• (g) Maintaining new organisms in containment for diagnostic purposes:

• (h) Such other purposes as the Authority thinks fit.

(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).

(1) Every person intending—

• (a) To import into containment any new organism; or

• (b) To develop any new organism in containment; or

• (c) To field test any new organism in containment—

shall, before importing or developing or testing, apply to the Authority for approval to import or develop that new organism.

(2) Every application shall be in an approved form and shall include any information prescribed, 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 such consideration, information about the containment system for the organism, and,—

• (a) For the development of a genetically modified organism,—

  • (i) The identification of the organism; and

  • (ii) The description of the project and the experimental procedures to be used; and

  • (iii) The details of the biological material to be used; and

  • (iv) The expression of foreign nucleic acid material; and

  • (v) All the possible adverse effects of the organism on the environment:

• (b) For field testing of a genetically modified organism,—

  • (i) The identification of the organism; and

  • (ii) The purposes of the field testing; and

  • (iii) The genetic modifications of the organism to be tested; and

  • (iv) The nature and method of field trials and the experimental procedures to be used; and

  • (v) All the possible adverse effects of the organism on the environment.

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

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

The Governor-General may, from time to time, by Order in Council, make regulations—

• (a) Specifying the procedures and methods for assessing the probability that an adverse effect will occur from genetic modification of an organism:

• (b) Specifying the probability that adverse effects will occur from specified development procedures:

• (c) Specifying the circumstances in which genetic modification of an organism is a low risk genetic modification.

(1) Where the Authority receives an application under section 40 of this Act to develop a genetically modified organism in containment, the Authority may make a rapid assessment of the adverse effects of developing that organism.

(2) If the Authority is satisfied that any development meets the criteria for a low-risk genetic modification specified in regulations made under section 41 of this Act, the Authority may approve the application and impose such controls providing for each of the matters specified in Schedule 3 to this Act as the Authority thinks fit.

(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 Schedule 3 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.

(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 Schedule 3 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).

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.

The Authority, when making a decision under section 45 of this Act, on an application made under section 40(1)(a) or (c) of this Act, shall have regard to—

• (a) The matters in section 37 of this Act; and

• (b) The ability of the organism to escape from containment.

(1) This section applies to an application—

• (a) to develop a new organism in containment that is a genetically modified organism, to the extent that the development does not take place in a containment structure:

• (b) to field test a new organism in containment if the new organism is a genetically modified organism.

(2) In deciding whether to approve or decline an application, the Authority must take into account—

• (a) any adverse effects of developing or field testing the organism on—

  • (i) human health and safety; and

  • (ii) the environment, in particular ecosystems and their constituent parts; and

• (b) any alternative method of achieving the research objective that has fewer adverse effects on the matters referred to in paragraph (a) than the development or field test; and

• (c) any effects resulting from the transfer of any genetic elements to other organisms in or around the site of the development or field test.

(3) The matters referred to in subsection (2) are in addition to the matters referred to in sections 44 and 45.

(4) [Repealed]

(1) After considering any application for approval made under section 40 of this Act, the Authority (if the application is not approved under section 42 or section 42A or section 42B) may, in its discretion,—

• (a) Approve the application if—

  • (i) The application is for one of the purposes specified in section 39(1) of this Act; and

  • (ii) After taking into account all the effects of the organism and any inseparable organism, including, but not limited to, the effects on the matters in section 43 of this Act (for applications made under section 40(1)(b) of this Act) or the matters in section 44 of this Act (for applications made under section 40(1)(a) or (c) of this Act), the beneficial effects of having the organism in containment outweigh the adverse effects of the organism and any inseparable organism; and

  • (iii) The Authority is satisfied that the organism can be adequately contained; or

• (b) Decline the application in any other case.

(2) An approval under this section—

• (a) must include controls that provide for each of the applicable matters specified in Schedule 3; and

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

(3) The Authority shall give its decision in writing, including reasons for the decision, give written notice of the decision to the applicant and every person who made a submission, and publicly notify the decision.

(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.

(1) This section applies to an approval under section 45—

• (a) to develop a new organism in containment that is a genetically modified organism, to the extent that the development does not take place in a containment structure; or

• (b) to field test a new organism in containment if the new organism is a genetically modified organism.

(2) An approval—

• (a) must include controls to ensure that, after the end of the development or field test, the organism and any heritable material from the organism is removed or destroyed; and

• (b) may include controls to ensure that, after the end of the development or field test and after heritable material is removed or destroyed, some or all of the genetic elements remaining from the organism are removed or destroyed.

(3) In subsection (2), destroyed includes leaving genetic elements to break down or become inactive at the site of the development or field test.

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

• (a) include controls that provide for each of the applicable matters specified in Schedule 3; 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.

(1) For the purposes of section 30(c) and sections 47 to 49 of this Act, emergency means—

• (a) An event involving the release of a new organism for which a national pest management strategy has been approved under section 68 of the Biosecurity Act 1993; or

• (b) a state of emergency declared under the Civil Defence Emergency Management Act 2002; or

• (c) An emergency as defined in section 2 of the Fire Service Act 1975; or

• (d) An emergency declared under Part 9 of this Act; or

• (e) A marine oil spill emergency under the Maritime Transport Act 1994.

(2) Sections 47 and 48 of this Act apply to every foreseeable emergency where the importation, release, or use of the hazardous substance or new organism in that emergency is also foreseeable.

(1) Every person intending to—

• (a) Import any hazardous substance for release in an emergency; or

• (b) Import any new organism for release in an emergency; or

• (c) Release any new organism from containment in an emergency; or

• (d) Release any hazardous substance from containment in an emergency; or

• (e) Use any hazardous substance in an emergency in a manner which would otherwise contravene the provisions of this Act or any regulations—

shall, before importation or release or use, apply to the Authority for approval to import or release or use.

(2) Every application shall be in an approved form and shall include—

• (a) Information to identify the substance or organism; and

• (b) Information showing that the hazardous substance or new organism is necessary to deal with an emergency; and

• (c) A proposed plan for dealing with the use of the substance or organism in the emergency; and

• (d) All information relating to the effects of the substance or organism; and

• (e) Such other information as may be prescribed.

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

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

(1) The Authority may approve or decline an application under section 47 of this Act, but may only decline the application if it is satisfied that—

• (a) The organism or substance is not necessary for use in the emergency; or

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

• (c) If the application relates to a new organism, the proposed plan does not adequately control the adverse effects of the 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).

(2) When approving the substance or organism in accordance with subsection (1) of this section, the Authority shall impose the following controls:

• (a) That the substance or organism only be released when an emergency has been declared under this Act or declared in accordance with the provisions of any other Act:

• (b) That the organism or substance only be released for a specified type of emergency:

• (c) That the organism or substance may only be released if the emergency is dealt with in accordance with a specified plan which includes:

  • (i) The measures which must be taken to avoid, remedy, or mitigate any actual or potential adverse effects from the use of that substance or organism:

  • (ii) The requirements for the disposal of the hazardous substance and any waste products:

  • (iii) The requirements for the eradication or control of any new organism.

(3) The Authority shall give its decision in writing, including reasons for the decision, give written notice of the decision to the applicant, and publicly notify it.

Subject to sections 49A to 50, nothing in this Act shall apply to any hazardous substance or new organism required for use in an emergency where—

• (a) The emergency; or

• (b) The use of the substance or organism in the emergency—

was not foreseeable.

In sections 49B to 49K,—

(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.

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.

(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.

(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.

(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).

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.

(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.

(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.

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.

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.

(1) Sections 49A to 49K apply, with all necessary modifications, to the rapid assessment and approval of other hazardous substances in special emergencies.

(2) In this section, other hazardous substances means hazardous substances that are not already covered by sections 49A to 49K by virtue of being contained in an agricultural compound or a medicine.

(1) The importation or release or development of any organism specified in Schedule 2 is prohibited.

(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.

(3) The Authority may, after declining any application made under this Act in relation to an organism, recommend to the Minister that an Order in Council be made to include the organism in Schedule 2, where the Authority is satisfied that—

• (a) The organism is likely to have any of the effects described in section 36 of this Act; and

• (b) Any likely adverse effects which may occur should the organism escape from containment would outweigh any likely beneficial effects of allowing the organism to be imported into containment.

(4) The Authority, when making a recommendation under subsection (3) of this section, may advise the Minister that a group of organisms should be included in Schedule 2 if it is difficult for persons to distinguish between high-risk and low-risk members of that group.

(5) Every Order in Council made under this section shall be deemed to be a regulation for the purposes of the Regulations (Disallowance) Act 1989.

(1) Nothing in this Act shall apply to any hazardous substance or new organism transhipped through New Zealand where any person has—

• (a) Received approval from the Authority to tranship the hazardous substances or new organism; and

• (b) Complied with any controls that the Authority has imposed on the transhipment.

(2) The Authority—

• (a) Shall decline approval to tranship any organism specified in Schedule 2:

• (b) May, within 10 working days after receipt of the application—

  • (i) Decline approval to tranship any hazardous substance or new organism if the Authority considers that the substance or organism cannot be adequately contained so as to prevent the environment from being exposed to the substance or organism or any adverse effects of the substance or organism; or

  • (ii) Approve the transhipment of any hazardous substance or new organism with such controls as the Authority thinks fit.