Hazardous Substances and New Organisms Amendment Act 2003

1: Title
1: This Act is the Hazardous Substances and New Organisms Amendment Act 2003.
2: In this Act, the Hazardous Substances and New Organisms Act 1996 the principal Act
2: Commencement
This Act comes into force on 30 October 2003.
3: Purpose of this Act
The purpose of this Act is—
a: to make certain changes to the Hazardous Substances and New Organisms Act 1996
i: streamlining the approval of the genetic modification of new organisms in laboratories; and
ii: providing for the approval of the conditional release of new organisms; and
iii: clarifying enforcement responsibilities; and
b: to improve the operation of the Hazardous Substances and New Organisms Act 1996
4: Interpretation
1: Section 2(1) conditional release approval section 38C conditionally released new organism host organism 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 qualifying medicine section 3 of the Medicines Act 1981
a: is or contains a new organism; and
b: meets the criteria set out in section 38I(3) qualifying organism qualifying veterinary medicine section 2(1) of the Agricultural Compounds and Veterinary Medicines Act 1997
a: is or contains a new organism; and
b: meets the criteria set out in section 38I(3) responsible chief executive Medicines Act 1981 Agricultural Compounds and Veterinary Medicines Act 1997 taxonomic classification .
2: Section 2(1) containment facility section 42 or 45 of this Act any of sections 42, 42A, 42B, or 45
3: Section 2(1) develop develop
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 .
4: Section 2(1) field test ; and includes large-scale fermentation of microorganisms
5: Section 2(1) organism
a: does not include a human being:
ab: includes a human cell: .
6: Section 2(1) organism other than a genetic structure derived from a human being other than a human cell
5: Meaning of new organism
1: Section 2A(1) paragraph (c)
ca: an organism for which a conditional release approval has been given:
cb: a qualifying organism approved for release with controls: .
2: Section 2A subsection (2)
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
ii: the organism is a qualifying organism and an approval has been granted under section 38I
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
ii: the organism is a qualifying organism and an approval has been granted under section 38I
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 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.
6: Matters relevant to purpose of Act
Section 6 paragraph (e)
e: the economic and related benefits and costs of using a particular hazardous substance or new organism.
7: Powers, functions, and duties of Authority
1: Section 11 paragraph (fa)
fb: approve standards for containment facilities: .
2: Section 11 subsection (2)
2: The Authority must, before exercising the function specified in subsection (1)(fb)
8: Eligibility for appointment as member of Authority
Section 16 subsection (2)
2: In subsection (1) matters
9: Delegation by Authority
1: Section 19(2)(a) section 35 or section 42 of this Act any of sections 35, 42, 42A, or 42B
2: Section 19(2) paragraph (b)
ba: the power to assess and approve an application under section 38I(1)
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
bd: the power to impose controls under section 45(2) section 55 of the Hazardous Substances and New Organisms Amendment Act 2003 .
10: Obligation to prepare and maintain register
Section 20(2) paragraph (c)
ca: if applicable, the project concerned: .
11: New
Part 4A The principal Act is amended by inserting, after Part 4
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.
12: Prohibition of import, manufacture, development, field testing, or release
1: Section 25(2) the Second Schedule to this Act Schedule 2
2: Section 25 subsection (3)
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)
7: Subsection (6) section 55(3) to (4B)
8: In this section,— innovative agricultural compound application section 72 of the Agricultural Compounds and Veterinary Medicines Act 1997 innovative medicine application section 23A of the Medicines Act 1981
13: Section 25AA
1: Section 25AA
2: Section 6 Hazardous Substances and New Organisms (Genetically Modified Organisms) Amendment Act 2002
14: Types of approval
1: Section 27 paragraph (b)
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: .
2: Section 27
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.
15: New
section 27A The principal Act is amended by inserting, after section 27
27A: Approvals at any taxonomic classification
1: An approval referred to in section 27(b), (ba), (bb), or (c)
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)
16: Section 29A
1: Section 29A
2: Section 10 Hazardous Substances and New Organisms Amendment Act 2000
17: Application for approval to import or release
1: Section 34(1) apply , under this section or under section 38A
2: Section 34(2) application under this section
18: New
section 34A The principal Act is amended by inserting, after section 34
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
3: If the application is granted, the approval takes effect immediately after the expiry of the conditional release approval.
19: Determination of applications to import or release
1: Section 38(1) of this Act or any other section
2: Section 38 subsection (2)
2: An approval under subsection (1)
3: Section 38 subsection (3)
3A: However, subsection (3)
20: New headings and
sections 38A to 38L The principal Act is amended by inserting, after section 38 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 section 38A The Authority may, with the agreement of the applicant, treat an application made under section 34 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
a: after taking into account the matters in subsection (3) section 36
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)
2: The matters to be taken into account under subsection (1)(c)
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)
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)
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
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
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
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
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)
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
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
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)
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 section 97 or section 97A
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
b: if it does so, must—
i: consult, and consider the views of, any government agency (as defined in section 49A
ii: publicly notify the results of the review.
3: This section does not limit section 67A
21: Importation or development of new organisms in containment
1: Section 39(1)(a) genetically modified new
2: Section 39 subsection (2)
2: A decision by the Authority under section 38 or section 38C or section 38I 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
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)
22: Application for containment approval for new organisms
Section 40(2)(b) and large scale fermentation
23: New
sections 42A 42B The principal Act is amended by inserting, after section 42
42A: Rapid assessment of projects for low-risk genetic modification
1: An application made under section 40 section 40(2)
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 subsection (1)
a: any host organism specified for the project meets the criteria for host organisms prescribed in regulations made under section 41
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)
a: approve the application; and
b: impose controls providing for each of the matters specified in the Third Schedule
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
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 Third Schedule
3: Section 25(4) section 19(2)(a)
24: New
section 43 The principal Act is amended by repealing section 43
43: Additional matters to be considered when application made for developing new organisms in containment
The Authority, when making a decision under section 45
a: in the case of an application made under section 40(1)(b) section 41
b: in the case of all applications made under section 40(1)(b) section 37
25: Additional matters to be considered for certain developments and field tests
Section 44A(4)
26: Determination of application
1: Section 45(1) section 42 of this Act section 42 or section 42A or section 42B
2: Section 45(1)(a)(ii) should the organism escape
3: Section 45
4: In taking into account the adverse effects of the organism under subsection (1)(a)(ii)
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.
27: New
section 45B The principal Act is amended by inserting, after section 45A
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
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
28: Exemptions from provisions of Act in emergencies
Section 49 section 50 of this Act sections 49A to 50
29: New heading and
sections 49A to 49K The principal Act is amended by inserting, after section 49 Rapid assessment and approval of agricultural compounds and medicines in special emergencies
49A: Interpretation
In sections 49B to 49K adverse event section 46(1) agricultural compound section 2(1) of the Agricultural Compounds and Veterinary Medicines Act 1997 government agency
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 medicine section 3 of the Medicines Act 1981 responsible Minister
a: this Act; or
b: the Agricultural Compounds and Veterinary Medicines Act 1997
c: the Biosecurity Act 1993
d: the Conservation Act 1987
e: the Fisheries Act 1996
f: the Health Act 1956
g: the Medicines Act 1981 special emergency 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
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) Gazette
49C: Application of
sections 49D to 49K Sections 49D to 49K
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)
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
2: Without limiting subsection (1)
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
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
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
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 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
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)
49K: Consequences of expiry of approval
On the expiry of an approval under section 49F
30: Prohibited organisms
1: Section 50(1) (3) (4) the Second Schedule to this Act Schedule 2
2: Section 50 subsection (2)
2: The Governor-General may, by Order in Council made on the recommendation of the Minister, amend Schedule 2
a: add a new organism that the Authority has, under subsection (3)
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) section 141
2B: An organism in Schedule 2 section 140(1)(ba)
31: Transhipment of substances and organisms
Section 51(2)(a) the Second Schedule to this Act Schedule 2
32: Applications required to be publicly notified
1: Section 53(1) paragraph (a)
ab: an application under section 38A .
2: Section 53(1)(b) section 35 or section 38I
3: Section 53(1)(c) , if the application has not been approved under section 38I
4: Section 53(2)(b) or section 42A or section 42B
5: Section 53(4)(c) subparagraph (ii)
ii: any local authority (within the meaning of the Local Government Act 2002
33: Information held on behalf of applicant
1: Section 55(3) paragraph (a)
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 .
2: Section 55(3)(b) That substance the substance or organism that is the subject of the application
3: Section 55(4)
a: after the words hazardous substances or new organisms
b: after the word substance or organism
4: Section 55(4A) paragraph (a)
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 .
5: Section 55(4A)(b) That substance the substance or organism that is the subject of the application
6: Section 55(4B)
a: after the words hazardous substances or new organisms
b: after the word substance or organism
7: Section 55(7) (4A)(b) (4B)(b)
34: Authority to withhold information
1: Section 57(2) immediately notify make all reasonable efforts to contact and notify immediately
2: Section 57 subsection (4)
4: The Authority may release the information or withhold the information in accordance with the Official Information Act 1982
a: the Authority has complied with subsection (2)
b: the time limit specified in subsection (3)
35: Further information
Section 58(1)(c) field test, conditionally release,
36: Time limits and waivers
1: Section 59(1)(a) section 28A or section 35 or section 42 of this Act paragraph (b)
2: Section 59(1) paragraph (b)
b: if any of sections 28A, 35, 38I, 42, 42A, or 42B
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.
3: Section 59(2) not later than 15 working days as soon as reasonably practicable but not later than 30 working days
37: Grounds for reassessment of a substance or organism
1: Section 62(1) containment , any conditionally released new organism, any qualifying organism released with controls,
2: Section 62(4) 42 38C, 38I, 42, 42A, 42B,
38: Reassessment
1: Section 63(2) paragraph (c)
ca: sections 38A to 38D and 54 to 61
cb: sections 38I to 38L and 54 to 58 .
2: Section 63
3: However, a reassessment of a qualifying organism released with controls is not required to be publicly notified in accordance with section 53
39: Minister's power to call in applications with significant effects
Section 68 subsection (1)
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.
40: Notification of Minister's direction
Section 69(1) 15 working days after receipt, by the Authority, of the application 30 working days after the date on which the Authority gives public notice of the application
41: Conduct of inquiry by Authority
Section 71 subsection (4)
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
42: Minister to decide application and notify decision
Section 73(3) Part VI
43: Part 5A
1: Part 5A
2: Section 9 Hazardous Substances and New Organisms (Genetically Modified Organisms) Amendment Act 2002
44: Enforcement of Act
Section 97 Act (including any controls imposed on approvals granted under this Act)
45: New
section 97A The principal Act is amended by inserting, after section 97
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) Biosecurity Act 1993
3: A person who may exercise powers under the Biosecurity Act 1993
4: Without limiting subsection (2) Biosecurity Act 1993 sections 162A, 163, and 164 of that Act
5: In this section,— enforcement agency Biosecurity Act 1993 unwanted organism section 2(1) of the Biosecurity Act 1993
46: Co-ordination of inspection
Section 98(1) (3) section 97 of this Act section 97 or section 97A
47: New
section 98A The principal Act is amended by inserting, after section 98
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
a: the chief executive of the department of State responsible for the administration of this Act:
b: the chief executive of the Authority.
48: Supervision of inspection
Section 99(1) section 97 of this Act section 97 or section 97A
49: Powers of entry for inspection
Section 103(1)(c) the conditions compliance with the conditions or controls on any hazardous substance or new organism
50: Form and content of compliance order
1: Section 106(d) , which shall not be less than 4 days from the time at which the notice is served
2: Section 106(f) and the last day on which a notice of appeal can be lodged
3: Section 106 subsection (2)
2: The period referred to in paragraph (1)(d) of this section
a: commence at the time the notice is served; and
b: be reasonable, having regard to the circumstances giving rise to the compliance order.
51: Penalties
Section 114 subsection (6)
6A: To avoid doubt, the Court may make an order under either or both of subsection (5) and subsection (6)
52: New
Part 7A The principal Act is amended by inserting, after Part 7
7A: Pecuniary penalties and civil liability for breaches relating to new organisms
124A: Interpretation
In this Part, unless the context otherwise requires,— Court enforcement agency 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 turnover 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
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
3: To avoid doubt, the Court may make an order under either or both of subsections (1) and (2)
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
2: Uncompleted proceedings for an order under section 124B 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)
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)
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
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 subsection (2) or subsection (3)
5: However, the defence under section 124H(2)(c)
6: If the Court is prevented by section 124B(3) subsection (2) or subsection (3) of this section section 124B
53: Regulations
1: Section 140(1) paragraph (b)
ba: prescribing organisms that are not new organisms for the purposes of this Act: .
2: Section 140(1) paragraph (f)
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) .
3: Section 140 subsection (2)
2A: Regulations may be made under subsection (1)(ba)
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.
54: New
Schedule 2 The principal Act is amended by repealing Schedule 2
55: Transitional provision: human cell research in containment
1: This section applies to a genetically modified human cell if, at the commencement of this section, the genetically modified human cell—
a: is present in New Zealand; and
b: is in a containment facility approved under section 39 Biosecurity Act 1993
2: A genetically modified human cell to which this section applies must be treated as if it had been approved under section 45
3: Subsection (2)
a: the genetically modified human cell; and
b: the nature and range of the genetic modification; and
c: the containment facility in which the genetically modified human cell is held.
4: The Authority may, by notice in writing to the holder of the genetically modified human cell,—
a: impose controls under section 45(2)
b: require the holder of the genetically modified human cell to supply to the Authority such further information relating to the cell as is specified in the notice.