Hazardous Substances and New Organisms Amendment Bill

Hazardous Substances and New Organisms Amendment Bill EXPLANATORY NOTE GENERAL POLICY STATEMENT The Hazardous Substances and New Organisms Amendment Bill (the Bill ) amends the Hazardous Substances and New Organisms Act 1996 (the HSNO Act ). The Bill implements policy changes responding to, and building on, recommendations of the Agricultural and Horticultural Products Regulatory Review (the Review ), undertaken by the Ministry for Regulation between August and December 2024. The Review made 16 interrelated recommendations to improve the proportionality, efficiency, transparency, and certainty of the pathways for approval of agricultural and horticultural products. The Bill gives effect to the recommendations of the Review that are related to the HSNO Act. The Bill has the following policy objectives: to streamline application processes and improve regulatory efficiency and transparency: to improve application pathways and provide certainty for applicants: to support risk‑proportionate decision‑making and public participation: to enhance compliance, monitoring, and enforcement under the HSNO Act. To achieve those objectives, the Bill amends the HSNO Act— to provide for all application forms under the HSNO Act to be approved by the Environmental Protection Authority (the Authority ); and to provide for levies to be prescribed by regulations, and require them to be paid by importers and manufacturers of hazardous substances, to support sustainable funding of the Authority’s functions as a regulator in relation to those substances; and to enable the following to be provided for in regulations: information required to accompany applications (which may vary between different classes or tiers of application, including classes or tiers that are based on risk and complexity): time frames relating to the processing of applications under Part 5 of the HSNO Act (including time frames currently set out in that Part); and to require the Authority to notify applicants under Part 5 of the HSNO Act whether or not their applications are complete and, if their applications are incomplete, to provide reasons and return those applications; and to expand the use of proportionate, light‑touch approval pathways where appropriate; and to enable greater reliance on assessments relating to hazardous substances that are undertaken by recognised international regulators; and to clarify processes for the reassessment of hazardous substances and new organisms; and to enable certain technical matters to be prescribed by notices made by the Authority; and to clarify and future‑proof key definitions; and to enable the Authority to determine taxonomic classifications for new organisms or groups of new organisms; and to enable temporary hazardous substance approvals to be sought, and granted, if a decision on a full application is pending and other criteria are met; and to allow multiple extensions of time for new organism release approvals if appropriate; and to provide a simplified pathway for transitioning conditional release approvals to approvals that allow the release of new organisms without controls if specified criteria are met; and to establish a new application pathway to enable approvals to be sought, and granted, for the development of vagrant prohibited new organisms in specified circumstances; and to improve the workability of approval provisions relating to emergencies (now adverse events) to support preparedness for, and response to, adverse events (including biosecurity incursions); and to enable the Authority to prescribe risk species by notice (while still retaining the power in the HSNO Act for this matter to be prescribed in regulations); and to enable the Authority to prescribe organisms as not new organisms by notice (instead of this matter being prescribed in regulations); and to enable the Authority to authorise the chief executive of the Authority, or a committee appointed by the Authority under the Crown Entities Act 2004, to prescribe— risk species by notice; or organisms as not new organisms by notice; and to allow the following powers to be delegated to the chief executive of the Authority, or that chief executive’s delegate, to support risk‑proportionate decision‑making: the power to hear and decide an application under Part 5 of the HSNO Act if it is not publicly notified: the power to proceed with, and decide on, any reassessment under Part 5 of the HSNO Act if it is not publicly notified; and to require the Authority to consider whether there is likely to be significant public interest in certain applications and other matters and, if the Authority considers that there is likely to be significant public interest, to require those matters to be publicly notified; and to require the Authority to hold hearings for applications and other matters that are publicly notified, or that are the subject of targeted consultation with affected persons, if those hearings would assist decision‑making; and to change key definitions and certain provisions to clarify regulatory oversight relating to new organisms; and to update provisions on persistent organic pollutants for better alignment with the Stockholm Convention on Persistent Organic Pollutants (to which New Zealand is a party); and to extend information‑sharing provisions to the chief executive of the department of State responsible for the administration of the Biosecurity Act 1993 (currently, the Director-General of the Ministry for Primary Industries) to strengthen compliance, monitoring, and enforcement; and to allow the Authority to assist with, or intervene in, certain enforcement matters where necessary or desirable to achieve the purposes of the HSNO Act. The Bill also contains minor and technical amendments, including amendments to improve accessibility for users. DEPARTMENTAL DISCLOSURE STATEMENT The Ministry for the Environment is required to prepare a disclosure statement to assist with the scrutiny of this Bill. The disclosure statement provides access to information about the policy development of the Bill and identifies any significant or unusual legislative features of the Bill. A copy of the statement can be found at http://legislation.govt.nz/disclosure.aspx?type=bill&subtype=government&year=2026&no=304 REGULATORY IMPACT STATEMENT The Ministry for Environment produced a regulatory impact statement on 6 May 2025 to help inform the main policy decisions taken by the Government relating to the contents of this Bill. A copy of this regulatory impact statement can be found at https://www.regulation.govt.nz/our-work/regulatory-impact-statements/ . CLAUSE BY CLAUSE ANALYSIS Clause 1 is the Title clause. Clause 2 is the commencement clause. Most of the provisions of the Bill will come into force on a date or dates set by the Governor-General by Order in Council or 2 years after Royal assent (if not brought into force earlier by Order in Council). The reason for the deferred commencement is that regulations will need to be made, and forms for applications will need to be approved, to give effect to the relevant provisions of the Bill. The remaining provisions will commence on the day after Royal assent. Clause 3 provides that the Bill amends the HSNO Act. MAIN AMENDMENTS Clause 4 amends section 2, which is the interpretation section. Clause 4(1) inserts a definition of qualifying medical device that is related to the amendment that clause 4(7) makes to the definition of qualifying organism. In particular, that definition is expanded to include a new organism that is, or is contained in, a qualifying medical device (in addition to a new organism that is, or is contained in, a qualifying medicine or qualifying veterinary medicine). As a qualifying organism is a kind of new organism, importing a qualifying organism for release, or releasing a qualifying organism, generally requires an approval under Part 5 of the HSNO Act ( see , for example, section 25). Clause 4(6) and (8) amends the definitions of qualifying medicine and qualifying veterinary medicine to ensure alignment with section 38I(3) (including as amended by clause 54(4) ). The definition of large-scale fermentation, which is inserted by clause 4(1) , applies to the new definition of develop. Clause 4(2) replaces the definition of develop in relation to a new organism. Developing a new organism generally requires an approval under Part 5 of the HSNO Act ( see , for example, section 25). The new definition differs from the current definition as follows: the new definition covers large-scale fermentation (instead of any fermentation) using a new organism that is a micro-organism: the new definition expressly covers breeding, propagating, growing, or raising a new organism: the new definition covers the carrying out of trials, tests, or other research of, on, or using a new organism (but continues to exclude field testing, which involves the carrying out of trials, of new organisms). The new definition also applies to new section 25(1B) ( see clause 23(2) ). Clause 4(9) replaces the definition of release in relation to a new organism. Importing a new organism for release, or releasing a new organism from containment, generally requires an approval under Part 5 before importation or release ( see sections 25 and 34(1)). Currently, the organism is released if it is allowed to move free of restrictions other than those imposed in accordance with the Biosecurity Act 1993 or the Conservation Act 1987. Under the new definition, releasing the organism generally consists of moving the organism, or allowing it to move or be moved, within New Zealand without containment (instead of free of restrictions). However, moving it, or allowing it to move or be moved, into containment is excluded from the definition. The term containment is defined in the HSNO Act to cover restricting an organism or a substance to a secure location or facility to prevent escape. In addition to the new definitions referred to above, clause 4(1) inserts definitions of approval, temporary hazardous substance approval, transhipment application, and unwanted organism for the purposes of the HSNO Act. The definition of approval refers to the definition of that term in new section 27 ( see clause 28 ). The definition of temporary hazardous substance approval refers to the definition of that term in new section 29AB ( see clause 33 ). Clause 4(3) amends the definition of enforcement officer as a consequence of new section 99A(4) ( see clause 142 ). Clause 4(4) repeals the definition of environmental medium as a consequence of clause 126 , which inserts an updated definition of that term into section 77B (the only provision in the HSNO Act in which that term is used). Clause 4(4) also repeals the definition of environmentally sound disposal. The substantive effect of that definition is inserted into section 66A, which is renumbered as new section 73A and repositioned in numerical order ( see clause 103 ). Clause 34 makes a consequential amendment to section 29B. Clause 4(5) removes matter from the definition of field test that is addressed directly, in relation to genetically modified organisms, by section 45A(2) (which requires an approval to field test a new organism that is a genetically modified organism to include controls requiring the organism and any heritable material from the organism to be removed or destroyed). Clause 4(10) amends the definition of risk species as a consequence of new Part 5A ( see clause 114 ). Clause 4(11) amends the definition of Stockholm Convention so that it will be updated as that Convention is amended without the need for Schedule 1AA (which sets out the text of that Convention) to be amended by Order in Council under section 140B. Related to this, section 140B and Schedule 1AA are repealed by clauses 150 and 155 , respectively. Clause 5 amends section 2A, which defines the term new organism for the purposes of the HSNO Act. Importing, developing, field testing, or releasing a new organism generally requires an approval under Part 5 of that Act ( see , for example, section 25). Clause 5(1) to (3) makes amendments that are related to, or a consequence of, new Part 5A ( see clause 114 ). Under section 2A, an organism belonging to a species that was not present in New Zealand immediately before 29 July 1998 is generally a new organism for the purposes of the HSNO Act. Clause 5(4) ensures that an organism that belongs to a migratory species that was present in New Zealand from time to time before 29 July 1998 (whether or not immediately before that date) and whose arrival in New Zealand before that date occurred without human intervention is also not a new organism for the purposes of the HSNO Act. Clause 6 amends section 3 to correct errors. The amendments also make non-substantive changes to improve accessibility for users, including by removing references to expired provisions and updating language. Section 3 provides that the HSNO Act binds the Crown but that it does not, except as provided by that section, apply to hazardous substances that are controlled by the Minister of Defence ( Defence-controlled substances ). Section 3 further provides that— the Chief of Defence Force must develop codes of practice for EPA controls for Defence-controlled substances that are contained in any weapons system and those codes of practice must be based on relevant EPA controls or meet requirements prescribed by relevant EPA notices or regulations made under the HSNO Act; and the Chief of Defence Force must ensure that methods of controlling Defence-controlled substances that are not contained in any weapons system are based on relevant EPA controls or meet requirements prescribed by relevant EPA notices or regulations made under the HSNO Act; and the Secretary of Defence must audit the EPA controls for hazardous substances under the Defence Act 1990 and report the results of the audit to the Minister for the Environment and the Minister of Defence. As EPA controls are imposed by the Environmental Protection Authority (the Authority ) rather than the Chief of Defence Force, it is not possible for the Chief of Defence Force or the Secretary of Defence to comply with the requirements relating to codes of practice or auditing as currently written. Further, the Secretary of Defence does not carry out audits under the Defence Act 1990 but instead has the function of arranging for certain assessments and audits (as and when required by the Minister of Defence, or in line with a programme of audit and assessment approved by that Minister). The amendments correct those errors so that— the Chief of Defence Force is required to ensure that the codes of practice for the hazardous substances concerned (rather than codes of practice for EPA controls for those hazardous substances) are in place ( see new section 3(3) ); and the Secretary of Defence must arrange for the codes of practice, and the methods of controlling Defence-controlled substances, to be assessed and audited, and the relevant provision of the Defence Act 1990 is to be applied in relation to the findings of an audit and assessment ( see new section 3(6) and (6A) ). Currently, section 3 also— allows any person to report a breach of the EPA notices in relation to Defence-controlled substances (which the codes of practice are required to meet if they are not based on the relevant EPA controls and the methods for controlling hazardous substances may be required to meet if they are not based on the relevant EPA controls); and allows the Minister of Defence and the Minister of Justice to direct that an inquiry be held before a District Court Judge into any incident involving an EPA control relating to a Defence-controlled substance if the incident is not being investigated under the Armed Forces Discipline Act 1971. The amendments also allow— any person to report to the Authority a failure to comply with a code of practice or to use a method of control (instead of a breach of requirements of the regulations under the HSNO Act or EPA notices) relating to Defence-controlled substances ( see new section 3(7) ); and the Minister of Defence and the Minister of Justice to direct that an inquiry be held before a District Court Judge into any incident involving a code of practice or method of that kind (instead of an EPA control) if the incident is not being investigated under the Armed Forces Discipline Act 1971 ( see the amendment made to section 3(8)). Clause 7 amends section 9, which— allows a methodology to be established by Order in Council for decisions of the Authority under Part 5; and provides that the Authority must not proceed to determine an application until such an Order in Council has been made. The effect of the amendment is that a methodology is not required to be established for any decision relating to an application for a temporary hazardous substance approval or any decision relating to the reassessment of a hazardous substance that is the subject of a temporary hazardous substance approval ( see clauses 33 and 91 ). Clause 8 amends section 11 to allow the Authority to approve forms for applications under the HSNO Act (instead of just applications under Part 5). Clause 9 renumbers section 17 as new section 10A and repositions that section in numerical order in Part 3. Clause 10 inserts a new subpart 1 heading as part of restructuring Part 4 into subparts. Clauses 11, 13, 18, and 20 insert further subpart headings into Part 4. Clause 21 renumbers section 24 as new section 11A and repositions that section in numerical order in Part 3. Clause 11 inserts a new subpart 2 heading as part of restructuring Part 4 into subparts. Clause 12 amends section 19, which allows the Authority to delegate the functions, powers, or duties that are conferred or imposed on it under the HSNO Act. The amendments— correct wording; and repeal redundant provisions; and make changes as a consequence of the insertion of the definition of qualifying medical device into section 2(1), the amendment to the definition of qualifying organism in section 2(1), and amendments made to section 38I(3) ( see clauses 4(1) and (6) and 54 ); and provide for the delegation of the following powers to the chief executive of the Authority (and consequential changes): the power to hear and decide any application under Part 5 if it is not publicly notified under new section 53 ( see clause 85 ): the power to proceed with and decide on any reassessment under subpart 9 of Part 5 if the application for the reassessment, or the decision to proceed with the reassessment, is not publicly notified under new section 53 ( see clauses 90 to 98 ); and provide for the delegation of the following powers to the chief executive of the Authority: the power to appoint an enforcement officer under new section 99A(4) ( see clause 142 ): the power under new section 141K to vary a time limit imposed under the HSNO Act ( see clause 154 ). Clause 13 inserts a new subpart 3 heading as part of restructuring Part 4 into subparts. Clause 14 amends section 20, which requires the Authority to keep a register of applications for approvals and other matters. The amendments— replace the heading to section 20 with a more descriptive heading; and repeal or replace redundant provisions; and insert a new requirement for the register to record, for each approval to import a new organism for release or to release a new organism from containment that is granted under section 38, certain matters relating to notification under new section 38AAC ( see clause 47 ) of the organism’s release; and replace a right to inspect the register during the ordinary office hours of the Authority with a requirement for the Authority to make the register publicly available on an Internet site maintained by or on behalf of the Authority. Clause 15 inserts new section 20AA , which requires the Authority to keep a register of decisions under new Part 5A (inserted by clause 114 ). Clause 16 amends section 20A, which requires the Authority to keep a register of exposure limits for substances with toxic or ecotoxic properties. The amendment replaces a right to inspect the register during the ordinary office hours of the Authority with a requirement for the Authority to make the register publicly available on an Internet site maintained by or on behalf of the Authority. Clause 17 repeals section 20B, which generally requires— a decision on an application under Part 5 or 6A to be in writing; and a copy of the decision to be given to the applicant and persons who made submissions; and the decision to be publicly notified. The repeal is a consequence of new sections 57 and 58 (inserted by clause 87 ) and new section 96O (inserted by clause 137 ). Clause 18 inserts a new subpart 4 heading as part of restructuring Part 4 into subparts. Clause 19 amends section 20C, which provides for a work plan that sets the priority for reassessments of hazardous substances that are requested by the chief executive of the Authority. The Authority must ensure that the work plan gives highest priority to hazardous substances that are prohibited from use under section 64 or subject to a restriction under section 64A of the HSNO Act. The amendments— replace the heading to assist the reader to understand that the work plan relates only to reassessments of hazardous substances (and not also to reassessments of new organisms); and ensure that the Authority is not required to ensure that the work plan gives highest priority to reassessments of hazardous substances that are the subject of temporary hazardous substance approvals ( see clauses 33 and 91 to 100 ). Clause 20 inserts new subpart 5 ( new sections 20D to 20J ) into Part 4. New subpart 5 requires persons who import hazardous substances and persons who manufacture hazardous substances to pay a levy prescribed by the regulations to the Authority or to a prescribed person on behalf of the Crown (that is, a person who is prescribed by the regulations). The levies are used to fund— a portion of the costs of the Authority in performing or exercising its functions, duties, or powers under the HSNO Act; and the costs of collecting the levy money. Other features of new subpart 5 of Part 4 are as follows: the regulations may provide different levies for different classes of specified persons (defined as persons who import hazardous substances and persons who manufacture hazardous substances): the regulations may exempt any class of specified persons from paying a levy: the Minister may exempt any specified person from the requirement to pay a levy under the new subpart: the Minister must, before recommending regulations, consult the Authority and persons who import or manufacture hazardous substances who the Minister considers are likely to be affected by the proposed regulations (or representatives of those persons): before recommending regulations that exempt any class of specified persons from paying a levy, and before granting an exemption to a specified person from paying the levy, the Minister must— have regard to the purpose of the levy; and be satisfied that the extent of the exemption is no broader than is reasonably necessary to address the matters that gave rise to the exemption. Clause 20 also inserts a new subpart 6 heading as part of restructuring Part 4 into subparts. Clause 22 replaces the cross-heading above section 25 with a new subpart 1 heading as part of restructuring Part 5 into subparts. Clauses 26, 30, 38, 68, 85, 106, and 113 insert subpart headings into Part 5 or replace cross-headings with subpart headings in that Part. Clause 22 replaces a cross-heading with a subpart 1 heading as part of restructuring Part 5 into subparts. Clause 23 amends section 25, which generally restricts the following activities so that they are allowed only in accordance with an approval under Part 5: importing or manufacturing a hazardous substance: importing, developing, field testing, or releasing a new organism. Clause 23(1) removes words that are redundant because they refer to expired provisions. Clause 23(2) replaces section 25(1B). Currently, section 25(1B) provides for an exception for the Ministry for Primary Industries and any departments recognised by the Minister for Biosecurity under section 101(2) of the Biosecurity Act 1993 from the restriction on developing a new organism. The exception is limited to isolating, aggregating, multiplying, or using a new organism that is an incidentally imported new organism and must be for the purpose of identifying, managing, or eradicating that organism. New section 25(1B) expands the exception to cover breeding, propagating, growing, or raising (in addition to isolating, aggregating, multiplying, or using) a new organism, whether or not it is an incidentally imported new organism ( see paragraph (a)(iv) of the new definition of develop in clause 4(2) ). Clause 23(3) amends section 25(2) as a consequence of new section 25C(2) ( see clause 25 ). Clause 23(4) and (5) amends section 25 as a consequence of new section 141R ( see clause 154 ). Clause 24(1) amends section 25B, which prohibits a persistent organic pollutant being stored in New Zealand, by— amending the heading to that section; and repealing an exception to the prohibition, which allows the storage of a persistent organic pollutant if storage is specified in Schedule 2A for the persistent organic pollutant. The effect of repealing the exception is that a persistent organic pollutant may be stored in New Zealand only if it is stored in accordance with conditions specified by the Authority by notice (which is secondary legislation). Clause 25 replaces 2 savings provisions that no longer have any operation with new section 25C . New section 25C recreates the effect of section 50, which is repealed by clause 82 , with the following changes: developing a new organism that is specified in Schedule 2 is no longer prohibited outright (instead, developing such a new organism that is present in New Zealand and that the Authority considers to be a vagrant may be permitted in accordance with an approval granted under section 45, as amended by clause 66 ); and it is recognised that an organism may be prescribed as not a new organism (making it a denewed organism, as defined in new section 25C(6) ) by a notice made under new Part 5A or, as is currently the case, by regulations ( see clause 114 ). Clause 26 inserts a new subpart 2 heading as part of restructuring Part 5 into subparts. Clause 27 replaces provisions of section 26 that relate to the Authority’s function of determining, on application, whether or not an organism is a new organism. The new provisions recreate the effect of the existing ones with the following changes: the Authority may determine any 1 or more taxonomic classifications for an organism or a group of organisms; and the determination is no longer required to be issued by notice in the Gazette , but is instead required to be published on an Internet site maintained by or on behalf of the Authority. Clause 28 replaces section 27, which defines the term approval for the purposes of the HSNO Act. The definition of that term is reinserted in new section 27 with the following changes: to improve accessibility for users, cross-references to the provisions of the HSNO Act under which approvals are granted are added and wording is brought into line with wording in those provisions: consequential changes are made that arise from other amendments in the Bill: an approval to tranship a hazardous substance or new organism through New Zealand is added to the list of approvals. Clause 4(1) makes a related amendment by adding a definition of approval into the interpretation section (section 2). Clause 29 updates cross-references in section 27A as a consequence of new section 27 . Clause 30 replaces section 28 and the cross-heading above it and inserts a new subpart 3 heading (as part of restructuring Part 5 into subparts). New section 28 recreates the effect of the existing section 28 with changes. Currently, a person who intends to import or manufacture a hazardous substance otherwise than into containment must apply for an approval under section 28A or 29, except if an approval under that section already allows the manufacture or importation of that substance. Under that exception, the approval need not expressly apply to the person. New section 28 provides for a further exception, which is that the person applies for, and is granted, a temporary hazardous substance approval to import or manufacture the substance and that approval is in force. The existing section 28 also lists the information that must be included in every application under that section. New section 28 adopts a new approach of requiring an application under that section to instead contain, or be accompanied by, the information prescribed by regulations ( see new section 28(3) and the existing section 140(1)(t)). The Bill adopts this approach for other applications under Part 5 ( see clauses 33, 36, 40 to 42, 47, 48, 52, 53, 57, 59, 69, 84, and 92 ). Because of section 49 of the Legislation Act 2019, the information that regulations may prescribe could vary between different classes of applications under each of the sections concerned, including classes that are based on levels of anticipated complexity. The existing section 28 allows the Authority to require an applicant, on a case-by-case basis, to verify the application by statutory declaration. New section 28(3)(c) adopts a new approach of instead requiring an application to contain, or be accompanied by, a statutory declaration that verifies any of the prescribed information that regulations require to be verified in that way. This approach is also adopted for other applications under Part 5 ( see clauses 33, 36, 40 to 42, 47, 48, 52, 53, 57, 59, 69, 84, and 92 ). Clause 31 amends section 28A, which allows the Authority to make a rapid assessment of the adverse effects of importing a hazardous substance to which an application under new section 28 applies (instead of the longer assessment process provided for in section 29) and, if satisfied of certain matters, approve the hazardous substance under that section. The amendments— continue to allow the Authority to make a rapid assessment of those effects, but only if the application requests that the Authority make a rapid assessment of those effects ( see new section 28A(1) ); and provide that the Authority must not determine the application under section 29 if the Authority decides to decline to make a rapid assessment or decides to make a rapid assessment but not to approve the hazardous substance under new section 28A ( see new section 28A(5) ); and provide that, if the Authority considers that the application (if approved) will result in significant effects for New Zealand’s international obligations, the Authority must not approve the hazardous substance on the ground that the Authority is satisfied that the use of the same substance or a substance having similar compositions and similar hazardous properties has been lawfully authorised by an international regulator ( see new section 28A(3)(b) ). Clause 32 makes amendments to section 29 as a consequence of new section 28A(1) and (5) . Clause 33 inserts new sections 29A to 29AC , which allow a person to apply for a temporary hazardous substance approval for a use specified in the application, provide for the determination of the application, and provide for the duration of such an approval. The term temporary hazardous substance approval is defined in new section 29A ( see also the definition of that term that is inserted into section 2(1) by clause 4(1) ). Under new section 29A , a person may apply for a temporary hazardous substance approval if— the person has applied under new section 28 to carry out that importation or manufacture for the specified use; and the Authority has notified the person that the application under new section 28 is complete ( see also new section 52 , which is inserted by clause 85 ); and the determination of that application is pending; and the specified use of the hazardous substance has been lawfully authorised by at least 2 international regulators. Under new section 29AB , the Authority may grant the application only if— the Authority is satisfied that the approval would have an identified benefit for New Zealand for the duration of the approval; and controls will be imposed on the approval; and the Authority is satisfied that, for the duration of the approval, those controls would be sufficient to manage the risks associated with the specified use for which the approval would allow the hazardous substance to be imported or manufactured. Under new clause 29AC , a temporary hazardous substance approval expires on the earliest of the following: the expiry date specified in the approval (which must be no later than 4 years after the date on which the approval is granted): when the person to whom the approval is granted withdraws the related application that they made under new section 28 ): when that related application— lapses due to the applicant having failed, within the applicable period, to supply information requested under new section 52B ( see clause 85 ); or is determined under section 29. Clause 34 makes an amendment as a consequence of— the repeal of the definition of environmentally sound disposal by clause 4(4) ; and the reinsertion of the substance of that definition in section 66A (which is renumbered as new section 73A ( see clause 103 )). Clause 35(1) and (2) correct the heading to section 30 and certain wording in that section, respectively. Clause 35(3) makes an amendment to section 30 as a consequence of new section 46 ( see clause 68 ). Clause 36 amends section 31— to clarify wording; and to replace the list of the information required to be included in every application under section 31 with a requirement for an application under that section to instead contain, or be accompanied by, the information prescribed by regulations ( see also clauses 30, 33, 40 to 42, 47, 48, 52, 53, 57, 59, 69, 84, and 92 ); and to replace the Authority’s power to require an applicant, on a case-by-case basis, to verify an application under section 31 by statutory declaration with a requirement for an application under that section to instead contain, or be accompanied by, a statutory declaration that verifies any of the prescribed information that regulations require to be verified in that way ( see also clauses 30, 33, 40 to 42, 47, 48, 52, 53, 57, 59, 69, 84, and 92 ). Clause 37 amends section 33, which provides that nothing in the HSNO Act applies to any small-scale use of hazardous substances in research and development or teaching in a laboratory if certain requirements are met. Those requirements include that the use in the laboratory does not create or involve a hazardous substance for which any application for approval has been declined under the HSNO Act ( see section 33(1)(b)). Clause 37(3) replaces section 33(1)(b) with a requirement that the use does not create or involve a declined hazardous substance, as defined by new section 33(3) ( see clause 37(5) ). The term declined hazardous substance is defined to mean a hazardous substance that is declined, or an approval that is revoked, under new section 63 . This part of the definition, read with new section 33(1)(b) , recreates the effect of the existing section 33(1)(b). The reference to an approval being revoked under new section 63 is a consequence of that new section (which refers expressly to the revocation of an approval, as one option following a full reassessment, in place of suggestions that an approval may be declined following a full reassessment). The term declined hazardous substance is further defined to exclude a hazardous substance in certain circumstances, which has the effect, read with new section 33(2)(b) , of ensuring that the exemption provided for in section 33 is not automatically and permanently removed if an application for an approval, or an approval, relating to the hazardous substance is declined or revoked. The exemption will remain in place or be restored if the hazardous substance— is the subject of an approval that is in force (except if the hazardous substance is, or belongs to a class that is, prescribed by an EPA notice); or is the subject of an application for a temporary hazardous substance approval that is declined or a temporary hazardous substance approval that is revoked (except if the hazardous substance is, or belongs to a class that is, prescribed by an EPA notice); or is, or belongs to a class that is, prescribed by an EPA notice. See clause 33 , which inserts new sections 29A to 29AC , in relation to temporary hazardous substance approvals. Clause 38 inserts a new subpart 4 heading into Part 5 (as part of restructuring that Part into subparts), as well as a new cross-heading and new section 33A . New section 33A provides that every person intending to import for release, or to release from containment, any new organism must, before importation or release, apply to the Authority under section 34 (covering applications other than for a conditional release approval) or 38A (covering applications for a conditional release approval) for, and be granted, an approval to import or release the organism. New section 33A is a consequence of— clause 39 (which replaces the cross-heading above section 34 to make it clear that the group of provisions under the new cross-heading are not concerned with conditional release approvals); and the replacement of section 34(1) by clause 40 (which has the effect of making section 34 entirely about applications other than applications for a conditional release approval). Clause 39 replaces the cross-heading above section 34 to make it clear that sections 34 and 34A, new section 34B , sections 35 to 38, and new sections 38AA to 38AAC are about approvals for importing new organisms for release or releasing new organisms from containment, but not about conditional release approvals. Clause 40(1) replaces the heading to section 34 as a consequence of clause 40(2) . Clause 40(2) replaces section 34(1) to provide that a person may apply to the Authority for an approval (other than a conditional release approval) to import for release or to release from containment a new organism. Clause 40(3) — replaces the list of the information required to be included in every application under section 34 with a requirement for an application under that section to instead contain, or be accompanied by, the information prescribed by regulations ( see also clauses 30, 33, 36, 41, 42, 47, 48, 52, 53, 57, 59, 69, 84, and 92 ); and replaces the Authority’s power to require an applicant, on a case-by-case basis, to verify an application by statutory declaration with a requirement for an application under section 34 to contain, or be accompanied by, a statutory declaration that verifies any of the prescribed information that regulations require to be verified in that way ( see also clauses 30, 33, 36, 41, 42, 47, 48, 52, 53, 57, 59, 69, 84, and 92 ). Clause 41(1) replaces the heading to section 34A to make the content of that section clearer. An application under section 34A is treated as being an application under section 34. Clause 41(2) inserts new section 34A(1A) , which aligns section 34A with new section 34(2) by requiring an application under section 34A to— be in the approved form; and contain, or be accompanied by, the information prescribed by regulations; and contain, or be accompanied by, a statutory declaration that verifies any of the prescribed information that regulations require to be verified in that way. Clause 42 inserts new section 34B . Under that new section,— a person may apply to the Authority for approval to release, without controls, a new organism to which a conditional release approval applies; and the Authority may grant the application only if the Authority is satisfied that the criteria prescribed by an EPA notice for the purposes of the new section are met; and if the application is granted,— the approval takes immediate effect; and the conditional release approval expires with immediate effect; and the new organism may be released without controls. Clause 43 amends section 35, which allows the Authority, if it receives an application under section 34 to import a new organism (other than a genetically modified new organism) for release, to make a rapid assessment of the adverse effects of importing that organism for release (instead of the longer assessment process provided for in section 38) and approve the application without controls if satisfied of certain matters. The amendments— continue to allow the Authority to make a rapid assessment of those effects, but only if the application requests that the Authority make a rapid assessment of those effects ( see new section 35(1) , which is inserted by clause 43(2) ); and clarify that section 35 does not apply to an application under section 34 that relates to a qualifying organism ( see clause 43(1) and new section 35(6), which is inserted by clause 43(4) ); and remove a reference to the Biosecurity Act 1993 as a consequence of the insertion of a definition of unwanted organism into section 2(1) by clause 4(1) . Clause 44 amends section 36, which sets out circumstances in which the Authority must decline an application, to clarify that it applies to all applications made under section 34. Clause 46(2) and (3) amends section 38 as a consequence of clause 44 . Clause 45 amends the heading to section 37 to clarify that section 37 sets out additional matters to be considered in making a decision under section 38. Clause 46(1) makes an amendment to the heading to section 38 to clarify that it generally applies to the determination of applications made under section 34. Clause 46(4) repeals section 38(3) to (4) as a consequence of clause 47 . Clause 47 inserts new sections 38AA to 38AAC , which apply to approvals granted under section 38. New section 38AA provides for the duration of an approval granted under section 38. New section 38AAB allows the period for which such an approval remains in force to be extended by up to 5 years at a time on up to 3 occasions. Under the existing section 38(3), an approval may be extended by up to 5 years on 1 occasion only. New section 38AAC requires a person who releases an organism in accordance with an approval granted under section 38 to notify the Authority within 1 month after the date of release. However, the Authority may waive the requirement for notification. Clause 14 makes a related amendment to section 20 that requires the Authority to record in the register kept under that section whether or not it has been notified under new section 38AAC or has waived the requirement for notification. Clause 48 amends section 38A— to replace the list of the information required to be included in every application under section 38A with a requirement for an application under that section to instead contain, or be accompanied by, the information prescribed by regulations ( see also clauses 30, 33, 36, 40 to 42, 47, 52, 53, 57, 59, 69, 84, and 92 ); and to replace the Authority’s power to require an applicant, on a case-by-case basis, to verify an application under section 38A by statutory declaration with a requirement for an application to contain, or be accompanied by, a statutory declaration that verifies any of the prescribed information that regulations require to be verified in that way ( see also clauses 30, 33, 36, 40 to 42, 47, 52, 53, 57, 59, 69, 84, and 92 ). Clause 49 removes redundant matter from section 38B. Clause 50 amends section 38BA, which allows the Authority, if it receives an application under section 38A for a conditional release approval in respect of a new organism (other than a genetically modified new organism), to make a rapid assessment of the adverse effects of importing that organism for release or of releasing that organism from containment and grant a conditional release approval if satisfied of certain matters. The amendments— continue to allow the Authority to make a rapid assessment of those effects, but only if the application requests that the Authority make a rapid assessment of those effects ( see new section 38BA(1) , which is inserted by clause 50(1) ); and remove a reference to the Biosecurity Act 1993 as a consequence of the insertion of a definition of unwanted organism into section 2(1) by clause 4(1) . Clause 51 amends section 38E, which provides for the duration of a conditional release approval. Clause 51(1) and (2) makes amendments that clarify that a control on a conditional release approval may expressly provide for when the control expires (which may affect when the conditional release approval expires). Clauses 51(3) and 52 allow a conditional release approval to be extended on an application under new section 38F . That new section allows the period for which a conditional release approval remains in force to be extended by up to 5 years at a time on up to 3 occasions. There is currently no power to extend a conditional release approval. The existing section 38F (which clause 52 replaces) requires a new organism to be disposed of when a conditional release approval that applies to that organism expires unless another approval is granted before then. That provision is not recreated. Instead, disposal is to be dealt with entirely by controls that are imposed on the conditional release approval when it is granted ( see section 38D(1)(f)) or following a review under section 38G, as amended by clause 53 . Clause 53 amends section 38G, which allows the Authority to review controls that are imposed on a conditional release approval. The amendments set out in clause 53(1) and (3) preserve the current effect of section 38G, with the following changes: following a review, the Authority may— remove a control requiring the disposal of the new organism to which the approval applies if the Authority considers that the control is not necessary to prevent any adverse effect on human health or safety or the environment; or impose, amend, or replace a control requiring the disposal of the new organism to which the approval applies if the Authority considers that— imposing, amending, or replacing the control is necessary to prevent any adverse effect on human health or safety or the environment; or amending or replacing the control (if applicable) will not increase the likelihood of any adverse effect on human health or safety or the environment: an application for a review under section 38G must (in line with other applications under Part 5, as provided by clauses 30, 33, 36, 40 to 42, 47, 52, 57, 59, 69, 84, and 92 )— be in the approved form; and contain, or be accompanied by, the information prescribed by regulations; and contain, or be accompanied by, a statutory declaration that verifies any of the prescribed information that regulations require to be verified in that way: the applicant may withdraw the application by written notice to the Authority (in line with the position applying in relation to other applications under Part 5): provisions relating to public notification and consultation with government agencies are removed from section 38G (instead those matters are addressed in new sections 53 and 53C , which are inserted by clause 85 ). Clause 53(2) replaces a cross-reference to section 67A as a consequence of clause 104 , which renumbers that section as new section 73C and repositions it in numerical order. Clause 54 amends section 38I. Clause 54(1) and (3) inserts headings to assist readers to understand that the content of section 38I (including as amended) covers the following 2 main subjects: rapid assessments in respect of applications made under section 34 that relate to qualifying organisms (which are currently qualifying medicines and qualifying veterinary medicines, and are expanded to include qualifying medical devices ( see clause 4(1) and (7) )): determinations of whether medicines, medical devices, or veterinary medicines that are or contain new organisms are qualifying medicines, qualifying medical devices, or qualifying veterinary medicines, respectively. Clause 54(2) reinserts the content of section 38I(5) (replaced by clause 54(11) ) as new section 38I(1A) and extends it to cover a qualifying medical device. Currently, section 38I(3) allows the Authority or the responsible chief executive (as defined in section 2(1)) to determine that a qualifying organism is or is contained in a qualifying medicine or a qualifying veterinary medicine (if satisfied of certain matters). Clause 54(4) amends section 38I(3)— to expand that section to cover medical devices and qualifying medical devices; and to correct section 38I(3) so that what the Authority or the responsible chief executive may determine instead is that a medicine, medical device, or veterinary medicine that is or contains a new organism is a qualifying medicine, qualifying medical device, or qualifying veterinary medicine (if satisfied of certain matters). This aligns with new paragraph (b) of the definitions in section 2(1) of qualifying medicine, qualifying medical device, and qualifying veterinary medicine ( see clause 4(1), (6), and (8) ). Clause 54(5) and (10) makes amendments as a consequence of expanding section 38I(3) to cover medical devices. Clause 54(6), (8), and (9) makes corrections that are related to the correction made by clause 54(4) . Clause 54(7) inserts a guidance note. Clause 54(11) replaces section 38I(5) to insert definitions for the purposes of section 38I, as amended ( see also clause 54(2) ). Clause 55 replaces section 38J, which is currently expressed as applying if the Authority has delegated to the responsible chief executive its power to assess and approve an application under section 38 (an incorrect cross-reference). New section 38J has the same effect as the existing section 38J, with the following changes: the reference to the Authority delegating its power to assess and approve an application under section 38 is corrected so that it refers to delegating the Authority’s power under section 38I(1) to assess and approve an application, in line with existing and new section 19(2)(ba) ( see clause 12(3) ); and the reference to a fee set by the Authority is replaced with a reference to the charge set by the Authority to align with section 21, which allows the Authority to fix charges rather than to set fees; and the references to determining whether a medicine is a qualifying medicine or a veterinary medicine is a qualifying veterinary medicine are expanded to include determining whether a medical device is a qualifying medical device. Clause 56 amends section 38K, which sets out an inclusive list of the types of controls that may be imposed on the importation for release or release from containment of a qualifying organism. The amendments expand the list to cover controls relating to qualifying medical devices (in addition to those relating to qualifying medicines or qualifying veterinary medicines). Clause 57 amends section 38L, which allows the Authority to review controls that are imposed on an approval in respect of a qualifying organism under section 38I. Clause 57(1) replaces section 38L(2) with provisions that, in line with an application for a review under section 38G (as amended by clause 53 ),— require an application for a review under section 38L— to be in the approved form; and to contain, or be accompanied by, the information prescribed by regulations; and to contain, or be accompanied by, a statutory declaration that verifies any of the prescribed information that regulations require to be verified in that way; and allow the applicant to withdraw the application by written notice to the Authority. The existing section 38L(2) deals with public notification of, and consultation with government agencies on, the review. Those matters are instead dealt with in new sections 53 and 53C (which are inserted by clause 85 ). Clause 57(2) replaces a cross-reference to section 67A as a consequence of clause 104 , which renumbers that section as new section 73C and repositions it in numerical order. Clauses 58 to 67 amend provisions of the HSNO Act that relate to approvals to import a new organism into containment or develop or field test a new organism in containment ( containment approvals ). Clause 58(1) and (2) corrects the heading to section 39 and certain wording in that section, respectively. Clause 58(3) amends section 39 as a consequence of the definition of adverse event in new section 46 and the amendments made to section 47 ( see clauses 68 and 69 ). Clause 59 amends section 40, which relates to applications for containment approvals. New section 40(2) — is related to new section 25C(2) , which provides that the development of any new organism specified in Schedule 2 that is present in New Zealand and that the Authority considers to be a vagrant is permitted in accordance with an approval granted under section 45; and puts it beyond doubt that an application under section 40 for an approval to develop such a new organism may be made whether or not the new organism is present in New Zealand. The guidance note after new section 40(2) points out that importing a new organism specified in Schedule 2 is prohibited (so the new organism would need to arrive in New Zealand by other means). New section 40(3) — replaces the list of the information required to be included in every application under section 40 with a requirement for the application to instead contain, or be accompanied by, the information prescribed by regulations ( see also clauses 30, 33, 36, 40 to 42, 47, 48, 52, 53, 57, 69, 84, and 92 ); and replaces the Authority’s power to require an applicant, on a case-by-case basis, to verify an application under section 40 by statutory declaration with a requirement for the application to contain, or be accompanied by, a statutory declaration that verifies any of the prescribed information that regulations require to be verified in that way ( see also clauses 30, 33, 36, 40 to 42, 47, 48, 52, 53, 57, 69, 84, and 92 ). Clause 60 amends section 42. That section allows the Authority to make a rapid assessment of the adverse effects of developing a genetically modified organism in containment to which an application under section 40 applies (instead of the longer assessment process provided for in section 45) and, if satisfied of certain matters specified in regulations, approve the application under section 42. New section 42(1) continues to allow the Authority to make a rapid assessment of those effects, but only if the application requests that the Authority make a rapid assessment of those effects. New section 42(3) provides that section 42 does not apply in relation to the development in containment of a genetically modified organism that is a new organism specified in Schedule 2 and that the Authority considers to be a vagrant. This is a consequence of new section 25C(2) , under which the development of a new organism specified in Schedule 2 that the Authority considers to be a vagrant may be permitted in accordance with an approval granted under section 45 (not under any provision that allows an approval to be granted after a rapid assessment). Clause 61 amends section 42A, which allows the Authority to make a rapid assessment of the adverse effects of carrying out a project for the development of genetically modified organisms in containment if the application contains certain information (instead of the information currently listed in section 40(2)) and the Authority is satisfied of certain matters. In particular,— clause 61(1) repeals section 42A(1) as a consequence of replacing the list of the information required to be included in every application under section 40 with a requirement for the application to instead contain, or be accompanied by, the information prescribed by regulations ( see new section 40(3) , which is inserted by clause 59 ); and clause 61(2) amends section 42A(2) to allow the Authority to make a rapid assessment of the relevant adverse effects only if the application requests that the Authority make a rapid assessment of those effects; and clause 61(3) — makes an amendment similar to the amendment made by clause 60(2) (which inserts new section 42(3) ) and, as in that case, is a consequence of new section 25C(2) ; and inserts a definition for the purposes of section 42A(2) (as amended). Clause 62 amends section 42B to allow the Authority to make a rapid assessment under that section of the adverse effects of importing a genetically modified organism into containment only if an application under section 40 to import the organism into containment requests that the Authority make a rapid assessment under section 42B of those effects. Clause 63 replaces section 42C, which allows the Authority— to make a rapid assessment of the adverse effects of importing a new organism (other than a genetically modified organism) into containment, or of developing or field testing a new organism (other than a genetically modified organism) in containment, if an application under section 40 for a containment approval is made; and to approve the application if the Authority is satisfied that the importation, development, or field testing of the new organism is low-risk in accordance with regulations made under section 42C. New section 42C — continues to allow the Authority to make a rapid assessment of the adverse effects referred to above, but only if the application requests that the Authority make a rapid assessment of those adverse effects; and allows the Authority to approve the application if the Authority is satisfied that the importation, development, or field testing of the new organism meets the criteria for low-risk importation, development, or field testing that are prescribed by an EPA notice (instead of by regulations); and does not apply in relation to the development in containment of a new organism that is specified in Schedule 2 and that the Authority considers to be a vagrant. This aligns with new sections 42(3) and 42A(4) (inserted by clauses 60(2) and 61(3) , respectively) and, as in those cases, is a consequence of new section 25C(2) . Clause 64 amends section 43 to provide for an additional matter that the Authority must have regard to, when making a decision under section 45 on an application, if the application is for approval to develop a new organism in containment that is specified in Schedule 2 and that the Authority considers to be a vagrant. Clause 65 amends section 44— to require the Authority, when making a decision under section 45 about an application to import a new organism into containment or to field test a new organism in containment, to have regard to the ability of any heritable material arising from the organism to escape from containment if it is a genetically modified organism; and to allow the Authority, when making a decision under section 45 on an application to import a new organism into containment or to field test a new organism in containment, to have regard to the ability of any heritable material arising from the organism to escape from containment if it is not a genetically modified organism. Clause 66 amends section 45, which (among other things) allows the Authority to approve an application for a containment approval if certain criteria are met. The amendments allow the Authority to approve an application for a containment approval relating to a new organism that is specified in Schedule 2 and that the Authority considers to be a vagrant if— the Authority is satisfied that the organism and any offspring, progeny, or descendants of the organism will not escape from containment; and the other criteria currently applying under section 45 to the approval of an application for a containment approval are met. Clause 67 inserts new section 45AA , which provides for controls that must be included in an approval under section 45 to develop in containment a new organism that is specified in Schedule 2 and that the Authority considers to be a vagrant. Clauses 68 to 70 replace or amend provisions concerned with applications and approvals to carry out any of the following activities in connection with an emergency (as defined by section 46(1)): importing a hazardous substance or new organism for release in an emergency; or releasing a hazardous substance or new organism from containment in an emergency; or using a hazardous substance in an emergency in a manner that would otherwise contravene the HSNO Act or any regulations or EPA notice under that Act. Under the scheme set out in those provisions, an application may be made and an approval granted in advance of an emergency, so long as the emergency is foreseeable and the importation, release, or use of the hazardous substance or new organism concerned is also foreseeable. The importation of the hazardous substance or new organism may occur before an emergency, but release or use may only occur when an emergency has been declared under the HSNO Act or in accordance with another Act. Clause 68 replaces section 46 and a cross-heading with a new subpart 5 heading (as part of restructuring Part 5 into subparts), a new cross-heading, and new sections 46 and 46A . New section 46 defines the term adverse event and replaces the term emergency for the purposes of the scheme. The term adverse event— covers the same events (various kinds of emergencies) as in the current definition of emergency in section 46(1), other than an event involving the release of a new organism covered by a national pest management plan (within the meaning of the Biosecurity Act 1993); and also covers the arrival or establishment in New Zealand of an organism that is an unwanted organism ( see also clause 4(1) , which inserts a definition of unwanted organism into section 2(1)). New section 46A has a similar effect to the existing section 46(2). It requires the adverse event, and the release or use of the hazardous substance or new organism concerned in response to the adverse event, to be foreseeable. Clause 69 amends section 47. Clause 69(1) replaces the heading to section 47. Clause 69(2) and (3) makes amendments that have the effect of requiring every person intending to carry out any of the following activities to apply to the Authority for an approval: importing a hazardous substance or new organism for release or use in response to an adverse event (instead of for release in an emergency): releasing a hazardous substance or new organism from containment in response to an adverse event (instead of in an emergency): using a hazardous substance in response to an adverse event (instead of in an emergency) in a manner that would otherwise contravene the HSNO Act or any regulations or EPA notice under that Act. Clause 69(4) updates the language used in section 47(1). Clause 69(5) — replaces the list of the information required to be included in every application under section 47 with a requirement for an application under that section to instead contain, or be accompanied by, the information prescribed by regulations ( see also clauses 30, 33, 36, 40 to 42, 47, 48, 52, 53, 57, 59, 84, and 92 ); and replaces the Authority’s power to require an applicant, on a case-by-case basis, to verify an application under section 47 by statutory declaration with a requirement for an application under that section to contain, or be accompanied by, a statutory declaration that verifies any of the prescribed information that regulations require to be verified in that way ( see also clauses 30, 33, 36, 40 to 42, 47, 48, 52, 53, 57, 59, 84, and 92 ). Clause 70 amends section 48. Clause 70(1) replaces section 48(1)(a) to allow the Authority to decline an application under section 47 if satisfied that the substance or organism is not necessary for release or use in response to an adverse event (instead of for use in an emergency). Clause 70(2) replaces section 48(2), which requires the Authority, if it approves the application, to impose certain controls. New section 48(2) has the same effect as the existing section 48(2), with the following changes: it is no longer a requirement that the substance or organism concerned only be released when an emergency has been declared under the HSNO Act or in accordance with another Act: new section 48(2) refers to release or use for a specified type of adverse event (rather than release for a specified emergency). Clause 71 replaces section 49 with new sections 48A and 49 . New section 48A provides for an additional requirement that must be met before a hazardous substance or new organism to which an approval under section 48 applies may be released or used in response to an adverse event that is the arrival or establishment in New Zealand of an unwanted organism. The hazardous substance or new organism may be released or used only after the chief executive of the department of State that is responsible for the Biosecurity Act 1993 (currently the Director-General of the Ministry for Primary Industries (the Director-General )) gives notice in the Gazette stating that the activity is necessary for 1 or more of the following purposes: minimising the impact of the organism on natural and physical resources, human health, and overseas market access for New Zealand products: controlling the spread of the organism: reducing the geographical distribution of the organism: eradicating the organism. New section 49 provides that nothing in the HSNO Act applies to any hazardous substance or new organism that is required for release or use in response to an adverse event if the adverse event, or the release or use of the substance or organism in the adverse event, was not foreseeable (subject to new section 25C and sections 49A to 49L). It recreates the effect of the existing section 49 (except that new section 49 refers to an adverse event instead of an emergency). Clauses 58(3) and 73(1) make amendments as a consequence of the amendments made by clause 68 (in both cases) and clause 69 (in the case of the amendment made by clause 58(3) ). The cross-heading above section 49A and the provisions relating to the use of agricultural compounds and medicines in special emergencies (sections 49A to 49L) are amended to cover the use of medical devices in special emergencies ( see clauses 72, 73(2) and (3), and 74 to 81 ). Clause 73(1) replaces the definition of adverse event in section 49A as a consequence of the insertion of new section 46 by clause 68 . Clause 82 repeals section 50 and the cross-heading above it. Section 50 is recreated by clause 25 as new section 25C , with the changes described above. Clause 83 replaces the cross-heading above section 51 with a new subpart 6 heading as part of restructuring Part 5 into subparts. Clause 84 amends section 51. Clause 84(1) inserts a new heading before section 51(1). Clause 84(2) updates the language used in section 51(1). Clause 51(3) replaces section 51(2) with new section 51(2) to (5) — to expressly require a person to apply for, and be granted, an approval under section 51 before they tranship a hazardous substance or new organism through New Zealand; and to require an application under section 51 (in line with other applications under Part 5, as provided by clauses 30, 33, 36, 40 to 42, 47, 48, 52, 53, 57, 59, 69, 84, and 92 )— to be in the approved form; and to contain, or be accompanied by, the information prescribed by regulations; and to contain, or be accompanied by, a statutory declaration that verifies any of the prescribed information that regulations require to be verified in that way; and to allow the applicant to withdraw the application by written notice to the Authority (in line with provisions applying to other applications under Part 5); and to require the Authority to decline or approve the application within any period determined in accordance with the regulations (instead of within 10 working days after the application is received, as the existing section 51(2)(b) provides). Clause 85 replaces sections 52 to 53AA and the cross-heading above section 52 with a new subpart 7 heading (as part of restructuring Part 5 into subparts), new sections 52 to 53C , and 3 cross-headings. New section 52 requires the Authority to notify an applicant for an approval, a review, or a reassessment under Part 5 as to whether their application is complete (as defined in new section 52(3) ). The Authority must notify the applicant within the period that starts on the first working day after the application is lodged and ends on the day that is determined in accordance with the regulations. An application is not to be treated as having been made or received until the day on which the Authority notifies the applicant that the application is complete. New section 52A requires the Authority, when it notifies an applicant that an application is incomplete, to give written reasons for its decision that the application is incomplete and to return the incomplete application. If the application is lodged again, it is to be treated as a new application. New section 52B allows the Authority to request the applicant to supply further information relating to the application. It recreates the effect of section 52, with the following changes: the Authority is no longer required to make its request within 10 working days after the application is received: the application lapses if the applicant fails to comply with the request within the period determined in accordance with regulations (instead of within 1 year after the date of the request). New section 52C recreates the effect of section 58(1)(a) and (b), (2), and (3) (replaced by clause 87 ) with some changes. It allows the Authority to commission a report, seek advice, or obtain other information for the purpose of assisting the Authority in performing its functions in relation to an application, a review, or a reassessment under Part 5. The main changes are as follows: the Authority is required to notify applicants, and persons who made a submission in response to public notification or consultation, within a period that is determined in accordance with the regulations (instead of at least 10 working days before the Authority decides the application, review, or reassessment or any related hearing commences): the Authority may postpone its decision or any hearing only if it considers that the requested information relates to an area in which it lacks sufficient knowledge or expertise. New section 53 recreates the effect of section 53, which provides for public notification of certain applications for approval, with the following main changes: in all cases, the Authority is required to publicly notify those applications only if the Authority considers that there is likely to be significant public interest in the applications (instead of, in the case of some applications, being required to publicly notify the applications whether or not the Authority considers that there is likely to be significant public interest in them): public notification in respect of reviews of controls imposed on conditional release approvals or on approvals relating to qualifying organisms is provided for in new section 53 (instead of in sections 38G and 38L): public notification in respect of all reassessments is provided for in new section 53 , instead of only applying in respect of full reassessments ( see the existing sections 63, 63A, 63C, and 63D): public notification of applications or proposals relating to group standards is not provided for in new section 53 , but is instead provided for in Part 6A, which deals with group standards ( see new section 96E , which is inserted by clause 137 ): the closing date that must be stated on the public notice is the date that is determined in accordance with the regulations (instead of that closing date being 30 working days from the date of public notification, as is currently provided by section 59(1)(c)). New section 53A provides for consultation with affected persons on any matter to which new section 53 applies that is not to be publicly notified under that section, and on any application for approval under section 51 to tranship a hazardous substance or new organism through New Zealand. Consultation is required under new section 53A if the Authority considers that the matter or transhipment application will have— significant cultural, economic, environmental, ethical, health, or international effects; or significant effects in an area in which the Authority lacks sufficient knowledge or expertise. The content of new section 53A is similar to that of the existing section 53AA(3) to (6), except that those subsections only apply in relation to modified reassessments of hazardous substances under section 63A, 63C, or 63D. New section 53B provides for notification of departments, Crown entities, and local authorities about— any application under Part 5 (except an application for a review of controls imposed on a conditional release approval or an approval relating to qualifying organisms); or any decision of the Authority to proceed with a reassessment on its own initiative. New section 53B recreates the effect of section 53AA(1) (including as applied in relation to modified reassessments by sections 63A, 63C, and 63D) and section 58(1)(c). One difference is that new section 53B applies in relation to full reassessments under section 63. New section 53C provides for notification of departments and Crown entities about reviews of controls imposed on conditional release approvals or on approvals relating to qualifying organisms. It recreates the effect of sections 38G(2) and 38L(2), which are replaced by clauses 53 and 57 . Clause 86 makes amendments to section 54 as a consequence of new section 53 . Clause 87 replaces sections 55 to 59A with new sections 55 to 58 and a cross-heading. The content of sections 55 to 59A is reinserted (with changes) as follows: the content of section 55(1) and (2) is reinserted in new section 141N ( see clause 154 ): the content of section 55(3) to (7) is reinserted in new section 141R ( see clause 154 ): the content of section 56 is reinserted in new section 141O ( see clause 154 ): the content of section 57(1) is reinserted in new section 141P ( see clause 154 ): the content of section 57(2) to (4) is reinserted in new section 141Q ( see clause 154 ): the content of section 58(1)(a) and (b), (2), and (3) is reinserted in new section 52C ( see clause 85 ): the content of section 58(1)(c) is reinserted in new section 53B(3) ( see clause 85 ): the content of section 59(2) to (9) is reinserted in new subpart 3 of Part 10 ( see clause 154 ): the content of section 59A is reinserted in new section 56 ( see clause 87 ). New section 55(1) requires the Authority to assess and determine an application for an approval, a review, or a reassessment under Part 5 within any period determined in accordance with the regulations. New section 55(2) requires the Authority to complete a rapid assessment under certain provisions within any period determined in accordance with the regulations. The closest existing equivalent to new section 55(2) is section 59(1)(b)(i), which requires the Authority to make a rapid assessment within 10 working days after receipt of the application concerned. New section 56 provides for joint processing of certain applications in respect of hazardous substances that are, or include, related chemicals or substances. The new section recreates the effect of section 59A. New section 57 recreates the effect of section 20B(1)(a) and (b) and (2) (which is repealed by clause 17 ). It requires a decision on an application, a review, or a reassessment under Part 5, including the reasons for the decision, to be recorded in writing and a copy given to the applicant (if any) and any persons who made submissions in response to public notification or consultation under new section 53 or 53A . New section 58 requires the Authority to publicly notify its decision on an application, a review, or a reassessment under Part 5 by no later than any date determined in accordance with the regulations. However, the Authority may withhold information relating to a transhipment application if, in the Authority’s opinion, the information could pose a risk to national safety and security. The closest existing equivalents to new section 58 are— section 20B(1)(c) and (2) (which requires the Authority to give public notice of the decision as soon as practicable after the decision is made and provides for the same exception as is provided by new section 58 that allows the Authority to withhold information relating to a transhipment application); and section 59(2) (which requires the Authority to publicly notify its decision on an application as soon as is reasonably practicable but not later than 30 working days after the conclusion of a hearing on the application or, if there is no hearing, consideration of the application). Clause 88 replaces section 60 with a new subpart 8 heading (as part of restructuring Part 5 into subparts) and new sections 60 to 60B . New section 60(1) requires the Authority to hold a hearing in respect of an application, a review, or a reassessment under Part 5 if the Authority— has publicly notified or has consulted on the application, review, or reassessment under new section 53 or 53A ; and considers that a hearing would be likely to assist it in determining or making a decision on the application, review, or reassessment. This differs from the existing section 60, which provides for the Authority to hold a hearing in respect of an application (not in respect of a review or all types of full reassessment) only if— the Authority considers it necessary; or the applicant has requested the hearing; or a person has stated in a submission on the application or reassessment that they wish to be heard. New section 60(2) sets out what the Authority must take into account for the purposes of deciding whether a hearing would be likely to assist it in determining or making a decision on the application, review, or reassessment. New section 60(3) provides that new section 60 does not apply in relation to any application or reassessment that is the subject of a direction of the Minister under section 68 (the Minister’s power to call in certain applications). This recreates an effect of section 61(1) (which is replaced by clause 89(2) ). New section 60(3) does not refer to reviews because the Minister’s power to call in applications under section 68 does not apply in relation to reviews. New section 60A recreates the effect of section 59(1)(d) to (f) (replaced by clause 87 ) as it applies to hearings, with the following changes: the Authority must fix a date for commencement of the hearing that is no later than any date determined in accordance with the regulations (instead of not more than 30 working days after the Authority receives the application or the closing date for submissions, whichever is the later): the Authority must notify the applicant (if any), and any person who stated in a submission in response to public notification or consultation that they wish to be heard, of that fixed date and the time and place of the hearing (but that notification is not required to be given at least 10 working days before the fixed date as it is under the existing section 59(1)(e) and (f)). New section 60B provides that any information under new section 52C may be considered at any hearing conducted by the Authority. It has the same effect as the existing section 58(1A). Clause 89 amends section 61. Clause 89(1) makes a minor amendment to the heading to section 61. Clause 89(2) replaces section 61(1) to provide that section 61 applies if the Authority is required to hold a hearing in respect of an application, a review, or a reassessment ( see also new section 60(3) ). Clause 89(3) and (4) makes amendments as a consequence of clause 89(2) . Clause 89(5) replaces section 61(7) and (8) with new section 61(7), (7A), and (8) . New section 61(7) and (7A) generally has the same effect as the existing section 61(7). New section 61(8) has the same effect as the existing section 61(8). Clause 89(6) makes a minor change to the wording of section 61(9). Clause 90 inserts a new subpart 5 heading as part of restructuring Part 5 into subparts. Clause 91 amends section 62, which allows the Authority to decide, on an application made by any person, whether grounds exist for reassessing new organisms or hazardous substances that are the subject of certain approvals (described in that section as organisms and hazardous substances that have previously been assessed by the Authority). The amendments— ensure that an application may be made, and that the Authority may make a decision, under section 62 on whether grounds exist for reassessing a qualified organism, whether or not it has already been released with controls; and recreate the effect of section 20B (as relevant to applications under section 62), which is repealed by clause 17 ; and to assist readers, describe in more detail what it means for an organism or a hazardous substance to have previously been assessed by the Authority; and extend the hazardous substances that may be the subject of a decision under section 62 to a hazardous substance that is the subject of an approval granted under new section 29AB (which is inserted by clause 33 ). Clause 92 inserts new section 62A . Currently, section 63(1) allows any person to request the Authority to proceed with a reassessment following a decision that grounds exist to reassess the new organism or hazardous substances concerned. New section 62A(1) provides that the Authority may proceed with the reassessment on an application (rather than on request) or on its own initiative. New section 62A(2) makes it clear that the Authority may proceed with a modified reassessment under section 63A, 63C, or 63D only if the Authority is satisfied that certain preconditions are met. New section 62A(3) sets out requirements relating to the form and content of an application for a reassessment, which aligns with the approach adopted for other applications under Part 5 ( see clauses 30, 33, 36, 40 to 42, 47, 52, 57, 59, 69, and 84 ). New section 62A(4) allows an applicant to withdraw the application, which aligns with the position that currently applies in relation to applications for approval and that the Bill provides is to apply to other applications under Part 5 ( see clauses 53 and 57 ). Clause 93 replaces section 63 with new section 63 . New section 63(1), (2), and (5) recreates the effect of section 63, with the following changes: a full reassessment of a temporary hazardous substance approval may be carried out and, in that case, new section 29AB is to be applied ( see clause 33 ): new section 45AA ( see clause 67 ) is to be applied if a full reassessment is carried out of a new organism that— is specified in Schedule 2 and considered by the Authority to be a vagrant; and is the subject of an approval under section 45 to develop it in containment: new section 63 expressly allows the Authority, on completing a full reassessment, to— decide that the approval concerned may continue (with or without any variations); or revoke the approval concerned: it is put beyond doubt that nothing in new section 63 — prevents a person from making a new application for an approval under Part 5; or in the case of the reassessment of a hazardous substance that is the subject of a temporary hazardous substance approval, affects an application that the holder of the approval has made in respect of the hazardous substance under new section 28 ( see clauses 30 and 33 ). The only provisions in Part 5 that new section 63 states must be applied to an application for a reassessment, or a decision of the Authority to proceed with a reassessment on its own initiative, are provisions concerning the determination of applications for approval ( see new section 63(1), table, column 1 ). Other provisions that the existing section 63 states apply with all necessary modifications are not specified in new section 63 . Instead, those provisions, or their equivalents inserted by the Bill, are amended or worded so that they cover reassessments ( see , for example, new section 53 , which relates to public notification). Clause 94 amends section 63A, which allows a modified reassessment of a hazardous substance to be carried out if the Authority considers that certain preconditions apply. The amendments— expressly allow the Authority, on completing the modified reassessment, to decline to vary (instead of just to vary) any controls applying to a hazardous substance; and allow a modified reassessment of a new organism (instead of only a hazardous substance) and allow the Authority to vary or decline any controls applying to the new organism on completing the modified reassessment; and make changes as a consequence of new section 62A and the renumbering of section 67A as new section 73C ( see clauses 92 and 104 , respectively); and repeal section 63A(3), which states that certain provisions apply with all necessary modifications (instead, those provisions, or their equivalents inserted by the Bill, are amended or worded so that they cover reassessments); and repeal section 63A(7) and (8) as a consequence of new sections 63DA and 65(b) ( see clauses 98 and 101 , respectively). Clause 95 replaces section 63B with new section 63B . New section 63B has the same effect as the existing section 63B with changes as a consequence of new sections 53, 53A, 62A, and 96E ( see clauses 85, 92, and 137 ). Clause 96 amends section 63C, which allows a modified reassessment of a hazardous substance to be carried out if the Authority considers that certain preconditions apply. The amendments— make a change to the heading to section 63C as a consequence of expanding section 63A to include reassessments of new organisms ( see clause 94 ); and make changes as a consequence of new section 62A and the renumbering of section 67A as new section 73C ( see clauses 92 and 104 , respectively); and repeal section 63C(3), which states that certain provisions apply with all necessary modifications (instead, those provisions, or their equivalents inserted by the Bill, are amended or worded so that they cover reassessments); and expressly allow the Authority, on completing a modified reassessment under section 63C, to decline to vary (instead of just to vary) any EPA controls and other matters applying to a hazardous substance; and repeal section 63C(7) to (9) as a consequence of new sections 63DA and 65(b) ( see clauses 98 and 101 , respectively). Clause 97 amends section 63D, which allows a modified reassessment of a hazardous substance to be carried out if the Authority considers that certain preconditions apply. The amendments— make a change to the heading to section 63D as a consequence of expanding section 63A to include reassessments of new organisms ( see clause 94 ); and make changes as a consequence of new section 62A and the renumbering of section 67A as new section 73C ( see clauses 92 and 104 , respectively); and expressly allow the Authority, on completing a modified reassessment under section 63D, to decline to vary (instead of just to vary) any EPA controls and other matters applying to a hazardous substance; and repeal section 63D(3), which states that certain provisions apply with all necessary modifications (instead, those provisions, or their equivalents inserted by the Bill, are amended or worded so that they cover reassessments); and repeal section 63D(5) to (7) as a consequence of new sections 63DA and 65(b) ( see clauses 98 and 101 , respectively). Clause 98 inserts new section 63DA , which recreates the effect of sections 63A(7), 63C(8) and (9), and 63D(6) and (7) ( see clauses 94, 96, and 97 , respectively). Clause 99 replaces section 64 with new sections 64 and 64AA . Section 64 applies in cases where— the reassessment of a hazardous substance has been publicly notified; and the Authority has reasonable cause to believe that there is a significant actual or imminent danger to human health or safety or to the environment from the continued use of the substance. In those cases, the Authority may, by notice in the Gazette , direct that any further use of the substance is prohibited until a decision has been made following the reassessment. New section 64 has the same effect as the existing section 64 with the following changes: new section 64 applies in relation to a modified reassessment under section 63A, 63C, or 63D (instead of only to a full reassessment of a hazardous substance): new section 64 applies in relation to the reassessment of a new organism (instead of only to the reassessment of a hazardous substance) so that the Authority may direct that the activities allowed by the approval concerned are prohibited until a decision is made following the reassessment: the Authority must publish the notice on an Internet site maintained by or on behalf of the Authority as soon as practicable after the notice has been published in the Gazette : new section 64 does not apply in relation to the reassessment of a hazardous substance that is the subject of a temporary hazardous substance approval. New section 64AA applies in relation to the reassessment of a hazardous substance that is the subject of a temporary hazardous substance approval. It has a similar effect to the effect that new section 64 and the existing section 64 have in relation to the reassessment of a hazardous substance that is the subject of another kind of approval. New section 53 does not apply in relation to the reassessment of a hazardous substance that is the subject of a temporary hazardous substance approval, and this is reflected in new section 64AA (compared with new section 64(1)(a) ). Clause 100 amends section 64A, which allows the Authority to restrict (rather than generally prohibit) the use of a hazardous substance by notice in the Gazette if— the Authority has publicly notified a decision under section 62(2) that grounds exist to reassess a hazardous substance; and a reassessment relating to that decision has not been commenced or completed; and the Authority has reasonable cause to believe that there is actual or likely danger to human health or safety or the environment from the use of the substance; and the Authority has consulted the persons who the Authority considers are likely to be affected by the restriction. The notice remains in force until the decision on the reassessment is made or the request for reassessment is withdrawn. The amendments— expand section 64A so that it not only applies in relation to hazardous substances but also applies in relation to new organisms; and allow the Authority to restrict the relevant activity that is authorised by the approval in respect of a new organism; and provide for the notice that imposes restrictions to remain in force until the earliest of the following: the date on which the Authority completes, and makes a decision on, a reassessment relating to the hazardous substance or new organism: the date on which the applicant (if any) withdraws the application for a reassessment: the date on which the Authority declines to proceed with an application (if any) for a modified reassessment relating to the hazardous substance or new organism because it is not satisfied that the preconditions for proceeding with the application are met: the date that is 1 year after the notice is published in the Gazette , if an application for reassessment of the hazardous substance or new organism has not been made, or the Authority has not decided on its own initiative to proceed with a reassessment of the organism or substance, by that date. Clause 101 replaces section 65, which provides that no compensation is payable to any person for any loss in connection with certain outcomes arising from a reassessment or if a group standard is amended or revoked under section 96B(3). New section 65 is limited to matters relating to reassessments. In relation to group standards, see new section 96Q (which is inserted by clause 137 ). Otherwise, new section 65 has the same effect as the existing section 65, but with changes that reflect— the express power to revoke an approval that appears in new section 63 ( see clause 93 ); and the expansion of section 63A to allow modified reassessments of new organisms ( see clause 94 ); and the power to give directions under new sections 64 and 64AA ( see clause 99 ). Clause 106 replaces the cross-heading above section 68 with a new subpart 10 heading as part of restructuring Part 5 into subparts. Currently, section 68 allows the Minister to call in and decide an application under the HSNO Act if the Minister considers that the decision on the application will have certain significant effects. Clause 107(2) amends section 68(1) to expressly allow the Minister to call in reassessments. Clause 107(1) makes a consequential amendment to the heading to section 68. Clause 107(3) amends section 68(1) to allow the Minister to call in and decide an application under Part 5 (instead of under the HSNO Act). The power of the Minister to call in an application to issue, amend, or revoke a group standard is preserved by the insertion of new section 96M into Part 6A ( see clause 137 ). Clause 107(4) replaces section 68(1A) as a consequence of— the amendment made by clause 107(2) to expressly allow the Minister to call in reassessments; and new section 53(5) , which is equivalent to the existing section 53(4) ( see clause 85 ). Clauses 107(5), 108, 109, 110(1) and (3), 111, and 112 make amendments as a consequence of the amendment made by clause 107(2) to expressly allow the Minister to call in reassessments. Clause 110(2) makes an amendment as a consequence of— the amendment made by clause 107(2) to expressly allow the Minister to call in reassessments; and new section 52B , which is equivalent to the existing section 52 ( see clause 85 ). Clause 110(4) replaces section 71(3)— to recreate the effect of that subsection in a more direct and accurate way; and to require the Authority to give public notice of the inquiry in accordance with the regulations; and to refer to a reassessment as a consequence of the amendment made by clause 107(2) , which expressly allows the Minister to call in reassessments. Clause 103 amends section 66A, which provides that, if Schedule 2A does not specify a use for a persistent organic pollutant or a specified use has expired, no one may use the substance and the Authority may issue a direction requiring the environmentally sound disposal of the persistent organic pollutant. The amendments— change the heading to section 66A; and allow the Authority to instead issue a direction that specifies how persistent organic pollutants may be disposed of and that may also require persistent organic pollutants to be disposed of (whether or not a use is specified in Schedule 2A or has expired); and require the Authority to ensure that any such direction is not inconsistent with Article 6 of the Stockholm Convention; and renumber section 66A as new section 73A and reposition it in numerical order in new subpart 11 of Part 5 ( see clause 113 ). The repeal of the definition of environmentally sound disposal by clause 4(4) is a related amendment. The substantive effect of that definition is inserted into section 66A. Clause 104 renumbers sections 67 and 67A as new sections 73B and 73C , respectively, and repositions them in numerical order in new subpart 11 of Part 5 ( see clause 113 ). Clause 105 amends section 67B to enable the Authority to revoke an approval or a deemed approval in respect of a new organism if the Authority is satisfied that the approval or deemed approval is no longer in use ( see clause 105(2) ). Clause 105(1) makes a consequential amendment to the heading to section 67B. Clause 105(3) inserts definitions for the purposes of section 67B, as amended. Clause 105(4) renumbers section 67B as new section 73D and repositions it in numerical order in new subpart 11 of Part 5 ( see clause 113 ). Clause 113 inserts a new subpart 11 heading as part of restructuring Part 5 into subparts. Clause 114 inserts new Part 5A ( new sections 73E to 73J ). New Part 5A allows the Authority to, by notice,— prescribe a species, or a subspecies, an infrasubspecies, a variety, a strain, or a cultivar, as a risk species for the purposes of new section 2A(1)(aa) ; or prescribe an organism as not a new organism for the purposes of the HSNO Act; or authorise the chief executive of the Authority, or a committee appointed by the Authority under clause 14 of Schedule 5 of the Crown Entities Act 2004, to prescribe, by notice,— a species, or a subspecies, an infrasubspecies, a variety, a strain, or a cultivar, as a risk species for the purposes of new section 2A(1)(aa) ; or an organism as not a new organism for the purposes of the HSNO Act. The effect of prescribing a species, or a subspecies, an infrasubspecies, a variety, a strain, or a cultivar, as a risk species is that the risk species is a new organism for the purposes of the HSNO Act and, therefore, importing, developing, field testing, or releasing it generally requires an approval under Part 5 of that Act ( see , for example, section 25). The effects of prescribing an organism as not a new organism are that— organisms of the same taxonomic classification as the prescribed organism and, in the case of a genetically modified organism, with the same genetic modification as the prescribed organism are not new organisms for the purposes of the HSNO Act (and, therefore, importing, developing, field testing, or releasing those organisms does not require an approval); and the prohibition on importing, releasing, or developing organisms specified in Schedule 2 of the HSNO Act does not apply to the prescribed organism ( see new section 25C ). The Bill does not alter the current power, set out in section 140 of the HSNO Act, for regulations to prescribe a species, or a subspecies, an infrasubspecies, a variety, a strain, or a cultivar, as a risk species. Any such risk species is a new organism for the purposes of the HSNO Act if it was present in New Zealand when the regulation prescribing the species, or subspecies, infrasubspecies, variety, strain, or cultivar, as a risk species was published or notified in the Gazette ( see section 2A(1)(b)). A notice under new Part 5A (whether it is a notice of the Authority or of the chief executive of the Authority or a committee) is secondary legislation ( see new section 73F(2) and (3) ). A notice under new Part 5A may be made on the initiative of the authorised maker (that is, the Authority or, if applicable, the chief executive of the Authority or a committee) or on an application by another person ( see new section 73F(4) ). Before making a decision about whether to make the relevant secondary legislation, the authorised maker must— notify the Department of Conservation and any departments, Crown entities, and local authorities likely to have an interest in the proposal or application ( see new section 73G(1)(a) ); and consult persons who are likely to be directly affected if making the secondary legislation would be likely to have— significant cultural, economic, environmental, ethical, health, or international effects; or significant effects in an area in which the Authority lacks sufficient knowledge or expertise ( see new section 73G(1)(b) and (2) ). In deciding whether to prescribe a species, or a subspecies, an infrasubspecies, a variety, a strain, or a cultivar, as a risk species, the authorised maker must consider all submissions and comments received in response to the notification and the consultation (if any) about the relevant proposal or application ( see new section 73H(1) ). The authorised maker must also be satisfied of the matters set out in new section 73H(2) . In deciding whether to prescribe an organism as not a new organism, the authorised maker must consider all submissions and comments received in response to the notification and the consultation (if any) about the relevant proposal or application and other matters set out in new section 73I . New section 73J requires the authorised maker to publish the maker’s reasons for deciding to make or declining to make secondary legislation under new Part 5A on an Internet site maintained by or on behalf of the Authority. Clause 4(10) makes an amendment to the definition of risk species in section 2(1) as a consequence of the insertion of new Part 5A . Clause 15 makes an amendment that is related to new Part 5A . It inserts new section 20AA , which requires the Authority to keep a register of decisions under that new Part. Clause 25 inserts new section 25C , which includes a definition of denewed organism that recognises that an organism may be prescribed as not a new organism by a notice made under that new Part. Clause 115 replaces the heading to Part 6 to more accurately reflect the contents of that Part. Clauses 116, 117, 120, 122, 124, and 127 to 130 insert new cross-headings or amend existing ones. Clause 118 amends section 76, which currently allows the Authority to prescribe controls and requirements, by EPA notice, that relate to hazardous substances. The amendments allow the Authority to prescribe certain controls that relate to conditionally released new organisms and qualifying organisms released with controls. Clause 119 amends section 76A, which currently allows the Authority to prescribe other matters, by EPA notice, that relate to hazardous substances. The amendments— replace the heading to section 76A to reflect that other amendments to that section allow the Authority to prescribe matters that relate to new organisms; and enable the Authority to prescribe the method of estimating the quantity of any new organism that is imported or developed ( see also clause 148(1) , which consequentially amends section 140 (a regulation-making power) by repealing section 140(1)(d)); and repeal provisions as a consequence of amendments that replace lists of the information that the HSNO Act currently requires to be included in applications for approval under Part 5 with requirements for those applications to instead contain, or be accompanied by, the information prescribed by regulations ( see clauses 30, 36, 40, 48, 59, and 69 ); and enable the Authority to prescribe forms that relate to new organisms (instead of just hazardous substances). Clause 121 amends section 76C, which sets out certain procedures that apply in relation to the issuing of an EPA notice. Clause 121(1) and (2) makes amendments as a consequence of amendments made by clauses 118 and 119 , which expand sections 76 and 76A to include matters relating to new organisms. Clause 121(3) removes a cross-reference to a provision that has been repealed. Clauses 123 and 125 make amendments as a consequence of the insertion of new sections 29A and 29AB by clause 33 . Clause 126 reinserts the substance of the definition of environmental medium that is repealed by clause 4(4) with changes to reflect hazard groupings in the hazard classification system established under section 74 by EPA notice. It also inserts definitions that apply to the new definition of environmental medium. Clause 131 amends section 96 to replace an existing (and incorrect) cross-reference with a cross-reference to new subpart 9 of Part 5 (which relates to reassessments). Clause 132 amends the heading to Part 6A to identify that the Part is concerned with group standards for hazardous substances and products. Clause 133 inserts a new subpart 1 heading as part of restructuring Part 6A into subparts. Clause 134 reinserts the content of section 96E (which provides for the effect of a group standard) as new section 96AB . Clause 135 amends section 96B, which allows the Authority to issue, amend, or revoke a group standard. The amendments— replace the heading to section 96B; and replace provisions as a consequence of the expiry of Parts 11 to 15; and insert a guidance note to advise readers of new section 73D ( see clause 105 ); and in line with applications under Part 5 ( see clauses 30, 33, 36, 40 to 42, 47, 48, 52, 53, 57, 59, 69, 84, and 92 ), require an application for the issue, amendment, or revocation of a group standard— to be in the approved form; and to contain, or be accompanied by, the information prescribed by regulations; and to contain, or be accompanied by, a statutory declaration that verifies any of the prescribed information that regulations require to be verified in that way. Clause 136 amends section 96C, which sets out certain preconditions (mainly matters that the Authority must be satisfied of) before it issues or amends a group standard. The amendments— require the Authority to have particular regard to any information that WorkSafe gives the Authority in response to notification under new section 96G , generally recreating the effect of section 58(1)(c)(ii) as currently applied by the existing sections 96C(2) and 96D(2); and repeal or amend provisions as a consequence of, among other things,— the expiry of Part 11; and the insertion of new subparts 2 and 3 and new section 96N into Part 6A ( see clause 137 ); and new subparts 3 and 4 and new section 141R in Part 10, which generally recreate the effect of sections 55 to 57 and 59 ( see clauses 87 and 137 ). Clause 137 replaces section 96D to 96F with new subparts 2 to 4 of Part 6A . The effect of section 96D is generally recreated in new subparts 2 and 3 . The content of section 96E is reinserted as new section 96AB ( see clause 134 ). Section 96F is removed altogether as a consequence of the expiry of Parts 11 to 15. New subpart 2 of Part 6A , which comprises new sections 96D to 96G , provides for notification and consultation in respect of— applications to issue, amend, or revoke a group standard; and proposals of the Authority to issue, amend, or revoke a group standard (whether on an application or on its own initiative). New section 96D provides that new subpart 2 of Part 6A does not apply in relation to a group standard that the Authority amends on its own initiative if it considers that the effect of the amendment is minor or that the amendment corrects a minor or technical error. It recreates the effect of the existing section 96C(3) in relation to public notification and consultation. New sections 96E to 96G are generally the equivalent, for applications and proposals relating to group standards, to new sections 53 to 53B , which relate to applications, reviews, and reassessments under Part 5 ( see clause 85 ). New subpart 3 of Part 6A , which comprises sections 96H to 96L , provides for hearings in respect of— applications to issue, amend, or revoke a group standard; and proposals of the Authority to issue, amend, or revoke a group standard on its own initiative. New section 96H , which is in similar terms to new section 96D , provides that new subpart 3 of Part 6A does not apply in relation to a group standard that the Authority amends on its own initiative if it considers that the effect of the amendment is minor or that the amendment corrects a minor or technical error. It recreates the effect of the existing section 96C(3) in relation to hearings. New sections 96I to 96L are generally the equivalent, for applications and proposals relating to group standards, to new sections 60 to 60B , and section 61 (as amended by the Bill), which relate to applications, reviews, and reassessments under Part 5 ( see clause 88 and 89 ). New subpart 4 of Part 6A comprises new sections 96M to 96Q . New section 96M recreates, for applications for the issue, amendment, or revocation of a group standard, the effect of the provisions contained in Part 5 that relate to the Minister’s call-in power ( see also clauses 106 to 112 ). New section 96N is equivalent to new section 52C ( see clause 85 ). New sections 96O and 96P are equivalent to new sections 57 and 58 ( see clause 87 ). New section 96Q recreates the effect of section 65 (which is replaced by clause 101 ) in relation to the amendment or revocation of a group standard. Clause 138 amends section 97 (including its heading), which confers responsibility on various people for enforcement of the HSNO Act relation to hazardous substances. The amendments— make drafting improvements, including to assist readers to understand that section 97 is concerned with enforcement relating to hazardous substances and not also new organisms; and update the language used in section 97. Clause 139 amends section 97A— to insert cross-references to relevant sections; and to repeal a definition as a consequence of its insertion into section 2(1) ( see clause 4(1) ). Clause 140 amends section 97C, which authorises information sharing for the purpose of assisting the New Zealand Customs Service and persons responsible for enforcement under section 97, including the Authority. The amendments extend section 97C to enable information to be shared by or with the chief executive of the department of State responsible for the administration of the Biosecurity Act 1993 (who is responsible for enforcement in respect of new organisms under section 97A). Clause 141 makes an amendment to section 99 as a consequence of new section 99A . Clause 142 inserts new sections 99A and 99B . New section 99A applies if the Authority considers that— a person specified in section 97 is not sufficiently performing or exercising the person’s functions, duties, or powers relating to the enforcement of the provisions of this Act (including any controls imposed by approvals granted under this Act) that relate to hazardous substances (as referred to in section 99(1)); and it is necessary or desirable that the Authority do any of the following to achieve the purposes of this Act: perform or exercise all or any of those functions, duties, or powers in place of the person: intervene in the performance or exercise of all or any of those functions, duties, or powers in place of the person in a case in which the person has already performed or exercised (but not yet completed the performance or exercise of) functions, duties, or powers in respect of the case: assist with the performance or exercise of all or any of those functions, duties, or powers. The Authority— may perform or exercise, or intervene in the performance or exercise of, all or any of the functions, duties, or powers in place of the person, but only if the Authority has consulted the person about the proposal to do so; or may assist with the performance or exercise of all or any of the functions, duties, or powers, but only with the prior agreement of the person. New section 99B allows the Authority to require a person specified in section 97 to provide information that the Authority requires for the purpose of— deciding the matters referred to in new section 99A ; or performing or exercising, or intervening in or assisting with the performance or exercise of, all or any functions, duties, or powers under new section 99A . Clause 143 amends section 109, which provides for offences against the HSNO Act. The amendments provide for certain new offences as a consequence of new section 64 or 64AA and the amendment of section 64A ( see clauses 99 and 100 ). Clause 144 amends section 109A to increase the limitation period for commencing proceedings for an offence from the date that ends 12 months (instead of 6 months) after the earlier of— the date when the incident, situation, or set of circumstances to which the offence relates first becomes known to the person commencing the proceedings; or the date when the incident, situation, or set of circumstances to which the offence relates should reasonably have become known to the person. Clause 145 amends section 109B as a consequence of the amendment made by clause 144 . Clause 146 amends section 114, which provides for the maximum penalties in respect of offences against the HSNO Act, as a consequence of the amendments made to section 109 by clause 143 and the expiry of a provision. Clause 147 inserts a new subpart 1 heading as part of restructuring Part 10 into subparts. Clause 148 amends section 140, which empowers regulations to be made for specified purposes. The amendments mainly reflect other changes made by the Bill, in particular,— requiring all applications under Parts 5 and 6A to contain, or be accompanied by, the information prescribed by the regulations (which may be made under the catch-all power in section 140(1)(t)); and the provisions of new Part 5A that allow organisms to be prescribed under that Part as not new organisms for the purposes of the HSNO Act ( see clause 114 ); and the amendments to sections 76 and 76A that allow for certain matters relating to new organisms to be prescribed by an EPA notice ( see clauses 118 and 119 , respectively). The amendments also increase the maximum infringement fees that may be prescribed by the regulations for infringement offences against the HSNO Act from $3,000 to $12,000. Clause 149 replaces section 140A(1) and (2) to allow Schedule 2A (concerning persistent organic pollutants) to be amended by inserting, repealing, or replacing any item in that schedule or replacing the whole of the schedule. Clause 150 repeals section 140B as a consequence of— the amendment by clause 4(11) to the definition of Stockholm Convention in section 2(1); and the repeal of Schedule 1AA by clause 155 . Clause 151 makes amendments as a consequence of— the insertion of new section 20G ( see clause 20 ); and the replacement of section 55 and the insertion of new section 141R(5)(b) ( see clauses 87 and 154 ); and the replacement of section 140 by section 48 of the Hazardous Substances and New Organisms Amendment Act 2015; and the repeal of section 140B ( see clause 150 ). Clause 152 inserts a new subpart 2 heading as part of restructuring Part 10 into subparts. Clause 153 amends section 141F as a consequence of the repeal of section 96C(2) and the insertion of new subparts 2 and 3 of Part 6A ( see clauses 136 and 137 ). Clause 154 inserts— new subpart 3 ( new sections 141J to 141M ) into Part 10; and new subpart 4 ( new sections 141N to 141Q ) into Part 10; and a new subpart 5 heading (as part of restructuring Part 10 into subparts) that applies to new section 141R and the existing sections 142 to 150; and new section 141R . New sections 141J to 141M generally recreate the effect of section 59(3) to (9) (replaced by clause 87 ). New section 141J applies to a requirement for a person to supply information under the HSNO Act. The Authority may waive the requirement or give directions as to the terms on which the person must supply the information. New section 141K allows the Authority to vary a time limit imposed under the HSNO Act on the application of a person or the Authority’s own initiative. The Authority may vary the closing date for submissions in response to public notification under new section 53 , section 71, or new section 96E or 96M only if satisfied that the persons specified in new section 141K(3) have consented to the variation or would not be unduly prejudiced by it. However, new section 141L requires the Authority to extend the closing date for submissions in response to such public notification if certain provisions of the Trans-Pacific Partnership Agreement (done at Auckland on 4 February 2016) or the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (done at Santiago, Chile, on 8 March 2018) are applicable. New section 141M requires the Authority— to record a decision made under any of new sections 141J to 141L in writing; and to give a copy to any person who applied for a waiver, direction, or variation; and to give public notice of the decision. New sections 141N to 141Q recreate the effect of various provisions replaced by clause 87 . In particular,— new section 141N recreates the effect of section 55(1) and (2); and new section 141O recreates the effect of section 56 and expressly authorises the Minister to consider any information, in reaching a decision under section 73, that is withheld by a person in accordance with section 9(2)(b) of the Official Information Act 1982; and new section 141P recreates the effect of section 57(1), including as applied by other sections of the HSNO Act; and new section 141Q recreates the effect of section 57(2) to (4), including as applied by various sections of the HSNO Act. New section 141R recreates the effect of section 55(3) to (8) (replaced by clause 87 ) with changes. Part 6 of the Agricultural Compounds and Veterinary Medicines Act 1997 (the ACVM Act ) imposes restrictions on the Director-General using or disclosing confidential information that the Director-General receives in support of certain applications made under that Act, including innovative TNP applications (within the meaning of section 72 of that Act). The confidential information concerned includes trade secrets, and information with a commercial value that would, or would be likely to, be diminished by disclosure of the information. Currently, section 55 of the HSNO Act applies Part 6 of the ACVM Act to the Authority. The Authority is subject to the same restrictions as the Director-General in relation to confidential information received in support of an application made under the HSNO Act (a HSNO application ) if the hazardous substance or new organism to which the HSNO application relates is, or has been, the subject of an innovative TNP application made under the ACVM Act. The amendments extend the restrictions imposed on the Authority to cases in which an applicant under the HSNO Act advises the Authority that the applicant intends to make an innovative TNP application under the ACVM Act in respect of the hazardous substance or new organism to which their HSNO application relates within 6 months after making that application. The new restrictions cease to apply to the Authority 6 months after the relevant date defined in new section 141R(4) if an innovative TNP application that applies to the substance or organism is not made under the ACVM Act within that 6-month period. OTHER AMENDMENTS Clause 155 repeals Schedule 1AA, which sets out the text of the Stockholm Convention on persistent organic pollutants, as a consequence of the amendment by clause 4(11) to the definition of Stockholm Convention in section 2(1). The repeal of section 140B by clause 150 is related to the repeal of Schedule 1AA and the amendment to the definition of Stockholm Convention. Clause 156 makes an amendment to the Schedule 2 heading as a consequence of the insertion of new clause 25C and the repeal of section 50 ( see clauses 25 and 82 ). Clause 157 provides for a consequential amendment to the Medicines Act 1981 that is related to the amendments made by clauses 4(6) and 54 . The Parliament of New Zealand enacts as follows: 1 Title This Act is the Hazardous Substances and New Organisms Amendment Act 2026 . 2 Commencement This Act comes into force on a date or dates set by Order in Council. However, the following provisions come into force on the day after Royal assent: a section 4(1) (to the extent that it inserts definitions of approval, transhipment application, and unwanted organism), (3), (4) (to the extent that it repeals a definition of environmental medium), (5), and (11) : b sections 5(2) and (5), 6, 8, 10, 11, 12(1) to (3) and (8), 13, 14(1), (2), and (4), 16, 18, 19(1), 20, 21, 23(1), 24, 35(1) and (2), 37(1), (2), and (4), 41(1), 43(1) and (3), 44, 45, 46(1) to (3), 50(2), 51(1) and (2), 58(1) and (2), 65, 69(1) and (4), 84(1) and (2), 102(1), 115 to 117, 120, 122, 124, 126 to 130, 132, 135(1) and (2), 138 to 142, 144, 145, 146(2), 148(2) and (3), 149, 150, and 155 . Any part of this Act that has not come into force 2 years after Royal assent comes into force then. An Order in Council made under this section is secondary legislation ( see Part 3 of the Legislation Act 2019 for publication requirements. 3 Principal Act This Act amends the Hazardous Substances and New Organisms Act 1996. 4 Section 2 amended (Interpretation) In section 2(1), insert in their appropriate alphabetical order: approval has the meaning given in section 27 large-scale fermentation means fermentation, in 1 or more vessels that are capable of holding a total volume that is greater than 10 litres qualifying medical device means a medical device (as defined in section 3A of the Medicines Act 1981) that— a is or contains a new organism; and b is determined under section 38I(3) to be a qualifying medical device temporary hazardous substance approval means an approval under section 29AB transhipment application means an application for approval under section 51 to tranship a hazardous substance or new organism through New Zealand unwanted organism has the same meaning as in section 2(1) of the Biosecurity Act 1993 In section 2(1), replace the definition of develop with: develop , in relation to a new organism,— a means any of the following: i genetically modify an organism: ii regenerate the new organism from biological material of that organism that cannot, without human intervention, be used to reproduce that organism: iii in the case of a new organism that is a micro-organism, carry out large-scale fermentation using that organism: iv deliberately isolate, aggregate, multiply, breed, propagate, grow, raise, or otherwise use the new organism: v carry out trials, tests, or other research of, on, or using the new organism; but b does not include field testing of the new organism In section 2(1), definition of enforcement officer , replace or 99(3) with , 99(3), or 99A(4) . In section 2(1), repeal the definitions of environmental medium and environmentally sound disposal . In section 2(1), definition of field test , delete , but from which the organism, or any heritable material arising from it, could be retrieved or destroyed at the end of the trials . In section 2(1), definition of qualifying medicine , replace paragraph (b) with: b is determined under section 38I(3) to be a qualifying medicine In section 2(1), definition of qualifying organism , after qualifying medicine , insert , qualifying medical device, . In section 2(1), definition of qualifying veterinary medicine , replace paragraph (b) with: b is determined under section 38I(3) to be a qualifying veterinary medicine In section 2(1), replace the definition of release with: release , in relation to a new organism, means— a move the organism, or allow the organism to move or be moved, within New Zealand without containment; but b does not include moving the organism, or allowing the organism to move or be moved, into containment In section 2(1), definition of risk species , after under , insert Part 5A or . In section 2(1), definition of Stockholm Convention , paragraph (a), delete , a copy of the English text of which is set out in Schedule 1AA . 5 Section 2A amended (Meaning of term new organism) After section 2A(1)(a), insert: aa an organism belonging to a species, subspecies, infrasubspecies, variety, strain, or cultivar prescribed as a risk species by a notice under Part 5A : In section 2A(1)(b), after risk species , insert by regulations made under section 140 . In section 2A(2)(a)(i), replace section 35 with section 34B , 35, . In section 2A(2)(a)(iii) and (b)(iii), after prescribed , insert by a notice under Part 5A . After section 2A(2)(c), insert: d the organism belongs to a migratory species that was present in New Zealand from time to time before 29 July 1998, or immediately before that date, and whose arrival in New Zealand before that date occurred without human intervention. 6 Section 3 amended (Act to bind the Crown) Before section 3(1), insert: General In section 3(1), replace shall bind with binds . Before section 3(2), insert: Hazardous substances controlled by Minister of Defence In section 3(2), replace shall not with does not . Replace section 3(3) to (7) with: 3 The Chief of Defence Force must ensure that codes of practice developed by the Chief of Defence Force are in place for hazardous substances that are controlled by the Minister of Defence and contained in any weapons system. 4 The codes of practice must— a be based on the relevant EPA controls; or b meet the relevant requirements prescribed by EPA notices issued under section 75. 4A The codes of practice may incorporate or adapt any relevant international code of practice. 5 The Chief of Defence Force must ensure that methods of controlling hazardous substances that are controlled by the Minister of Defence and not contained in any weapons system— a are based on the relevant EPA controls; or b meet the relevant requirements prescribed by EPA notices issued by the Authority under section 75. 5A The Chief of Defence Force may comply with subsection (5) by following the relevant code of practice approved by the Authority under section 79. 6 The Secretary of Defence must arrange for the following to be assessed and audited (as and when required by the Minister of Defence, or in accordance with a programme of audit and assessment approved by that Minister): a the codes of practice referred to in subsection (3) ; and b the methods referred to in subsection (5) . 6A Section 24(2)(e) of the Defence Act 1990 is to be applied in relation to the findings of that assessment and audit and the Secretary of Defence must submit the report of those findings to the Minister, in addition to the Minister of Defence. 7 Any person may report to the Authority— a a failure to comply with a code of practice referred to in subsection (3) ; or b a failure to use a method referred to in subsection (5) . In section 3(8), replace breach of an EPA control relating to a hazardous substance under the control of the Minister of Defence with failure to comply with a code of practice referred to in subsection (3) , or a failure to use a method referred to in subsection (5) , . 7 Section 9 amended (Methodology to be used) Replace section 9(4) with: 4 A reference in this section to a decision under Part 5 does not include a reference to— a any decision relating to an application for a temporary hazardous substance approval; or b any decision relating to the reassessment of a hazardous substance that is the subject of a temporary hazardous substance approval, including— i a decision under section 62 as to whether there are grounds to reassess the hazardous substance; and ii a decision to proceed with the reassessment under subpart 9 of Part 5 . 8 Section 11 amended (Powers, functions, and duties of Authority) Replace section 11(1)(fa) with: fa approve forms for applications under this Act: 9 Section 17 renumbered as section 10A and repositioned (Restriction on Ministerial direction) Renumber section 17 as section 10A and reposition it after section 10. 10 New subpart 1 heading in Part 4 inserted After section 17, insert: 1 Committees and subcommittees 11 New subpart 2 heading in Part 4 inserted After section 18C, insert: 2 Delegations 12 Section 19 amended (Delegation by Authority) Repeal section 19(2)(a), (bd), and (ca). In section 19(2)(b), delete other . Replace section 19(2)(ba) with: ba the power under section 38I(1) to assess and approve an application that relates to a qualifying organism to the responsible chief executive: In section 19(2)(bb), replace or veterinary medicine is a qualifying medicine with , medical device, or veterinary medicine is a qualifying medicine, qualifying medical device, . In section 19(2)(bc), after qualifying medicines , insert , qualifying medical devices, . Replace section 19(2)(cb) and (cc) with: cb the power to hear and decide any application under Part 5, if it is not publicly notified under section 53 , to its chief executive: cc the power to proceed with and decide on any reassessment under subpart 9 of Part 5 , if the application for the reassessment, or the decision to proceed with the reassessment, is not publicly notified under section 53 , to its chief executive: Repeal section 19(2)(e). In section 19(2)(g), after section 99(3)(a) , insert or 99A(4) . After section 19(2)(ha), insert: i the power under section 141K to vary a time limit imposed under this Act to its chief executive. Replace section 19(5B) with: 5B However, if the delegate is the chief executive of the Authority and the power or function is a specified power or function, the chief executive may only delegate the power or function to an employee of the Authority. After section 19(7), insert: 8 In this section, specified power or function means— a a power or function under section 26 that relates to hazardous substances; or b a power referred to in subsection (2)(cb), (cc) , or (d). 13 New subpart 3 heading in Part 4 inserted In Part 4, after section 19, insert: 3 Registers 14 Section 20 amended (Obligation to prepare and maintain register) Replace the heading to section 20 with Register of applications for approvals, etc . Repeal section 20(3). Replace section 20(4) with: 4 The register must also record, for each approval to import a new organism for release or to release a new organism from containment that is granted under section 38, whether or not the Authority— a has been notified under section 38AAC of the organism’s release; or b has waived the requirement for that notification. Replace section 20(5) with: 5 The Authority must make the register available on an Internet site maintained by or on behalf of the Authority. 15 New section 20AA inserted (Register of decisions under Part 5A) After section 20, insert: 20AA Register of decisions under Part 5A 1 The Authority must keep a register that records the following matters: a each organism that is prescribed under Part 5A as not a new organism for the purposes of this Act: b each organism— i that is not prescribed as not a new organism for the purposes of this Act; and ii that an authorised maker (within the meaning of section 73E ) has declined, on an application made under Part 5A , to prescribe as not a new organism for the purposes of this Act: c for each organism that is referred to in paragraph (a) or (b) , a link to the statement of reasons that is required to be published under section 73J for prescribing, or declining to prescribe, the organism as not a new organism: d each species, subspecies, infrasubspecies, variety, strain, or cultivar prescribed under Part 5A as a risk species for the purposes of section 2A(1)(aa) : e each species, subspecies, infrasubspecies, variety, strain, or cultivar— i that is not prescribed as a risk species for the purposes of section 2A(1)(aa) ; and ii that an authorised maker (within the meaning of section 73E ) has declined, on an application made under Part 5A , to prescribe as a risk species for the purposes of section 2A(1)(aa) : f for each species, subspecies, infrasubspecies, variety, strain, or cultivar that is referred to in paragraph (d) or (e) , a link to the statement of reasons that is required to be published under section 73J for prescribing, or declining to prescribe, the species, subspecies, infrasubspecies, variety, strain, or cultivar as a risk species. 2 The Authority must make the register publicly available on an Internet site maintained by or on behalf of the Authority. 16 Section 20A amended (Register of exposure limits for substances with toxic or ecotoxic properties) Replace section 20A(3) with: 3 The Authority must make the register publicly available on an Internet site maintained by or on behalf of the Authority. 17 Section 20B repealed (Publication of decisions) Repeal section 20B. 18 New subpart 4 heading in Part 4 inserted In Part 4, above section 20C, insert: 4 Work plans 19 Section 20C amended (Reassessments work plan) Replace the heading to section 20C with Work plan for reassessments of hazardous substances . After section 20C(4), insert: 5 Subsection (4)(a) does not require the Authority to ensure that the work plan gives highest priority for reassessments of hazardous substances that are the subject of temporary hazardous substance approvals. 20 New subpart 5 of Part 4 inserted After section 20C, insert: 5 Levies of persons who import or manufacture hazardous substances 20D Meaning of specified persons In this subpart, specified persons means— a persons who import hazardous substances; and b persons who manufacture hazardous substances. 20E Levy of specified persons Every specified person must pay a levy prescribed by the regulations made under this subpart to— a the Authority; or b a prescribed person on behalf of the Crown (being a person who is prescribed by the regulations made under this subpart). 20F Interest on unpaid levy 1 A person who owes a levy under this subpart is liable to pay to the Authority or the prescribed person interest assessed at the rate and applied by the method (if any) prescribed by the regulations made under this subpart. 2 The interest is payable on— a any unpaid levy; and b any unpaid instalment payment in respect of any levy; and c any unpaid interest that has been charged already. 20G Levy regulations 1 The Governor-General may, by Order in Council made on the recommendation of the Minister, make regulations providing for the levies. Guidance note See sections 20H and 20I for procedural requirements with which the Minister must comply before making a recommendation under this section. 2 Levies must be prescribed on the basis that the following costs should be met fully out of the levies: a a portion of the costs of the Authority in performing or exercising its functions, duties, and powers under this Act relating to hazardous substances, where the size of the portion to be met by levies under this Act is determined by the Minister; and b the costs of collecting the levy money. 3 Levies may be prescribed on the basis that any actual cost that could have been, but has not been, recovered as a levy shortfall for a year may be recovered (along with any financing charge) over any period of up to 5 years. 4 The regulations may do any 1 or more of the following: a specify the amount of levies, or the method of calculating or ascertaining the amount of levies: b include in levies, or provide for the inclusion in levies of, any shortfall in recovering the actual costs: c refund, or provide for refunds of, any over-recovery of the actual costs: d provide for the payment and collection of levies (which may include providing for instalment payments): e provide for interest under section 20F : f provide different levies for different specified persons or different classes of specified persons: g specify the financial year or part financial year to which a levy applies, and apply that levy to that financial year or part financial year and each subsequent financial year until the levy is revoked or replaced: h require payment of a levy for a financial year or part financial year, irrespective of the fact that the regulations may be made after that financial year has commenced: i require specified persons to keep, and give to the Authority or another person, records and information to enable amounts of levy payable by the specified persons to be accurately calculated: j specify the form and manner in which, and the times at which, those records and information must be kept or given: k specify requirements for a person to verify that those records and information are correct before giving them to the Authority or any other person: l exempt any class of specified person from paying a levy: m provide for waivers or refunds of the whole or any part of a levy for any case or class of cases: n provide for anything that this subpart says may or must be provided for by regulations made under this subpart: o provide for anything incidental that is necessary for carrying out, or giving full effect to, this subpart. 5 Regulations made under this section are secondary legislation ( see Part 3 of the Legislation Act 2019 for publication requirements). 20H Consultation before making recommendation 1 Before making a recommendation for regulations under this subpart, the Minister must— a consult the Authority on the proposed regulations; and b consult specified persons who the Minister considers are likely to be affected by the proposed regulations or representatives of those persons. 2 A failure to consult as required by this section does not affect the validity of any regulations made under this subpart. 20I Exemption from paying levy Exemption of class of specified persons 1 Before making a recommendation for regulations under section 20G(4)(l) , the Minister must— a have regard to the purpose of the levy; and b be satisfied that the extent of the exemption is no broader than is reasonably necessary to address the matters that gave rise to the proposed exemption. 2 If the Minister makes a recommendation for regulations under section 20G(4)(l) , the Minister’s reasons for making the recommendation (including why the exemption is appropriate) must be published together with the regulations. Exemption of individual or named specified persons 3 The Minister may exempt any specified person from the requirement to pay a levy under this subpart. 4 Before granting an exemption under this section, the Minister must— a have regard to the purpose of the levy; and b be satisfied that the extent of the exemption is no broader than is reasonably necessary to address the matters that gave rise to the proposed exemption. 20J Miscellaneous provisions relating to levies 1 If a person is in 2 or more classes of specified persons in respect of which different levies have been prescribed by the regulations made under this subpart, the person must pay each of those levies (unless the regulations provide otherwise). 2 The amount of any unpaid levy and of any interest under section 20F are recoverable in any court of competent jurisdiction as a debt due to the Authority, or to any other person prescribed for the purposes of this subsection by regulations made under this subpart, on behalf of the Crown. 3 The Authority, or any other person prescribed for the purposes of this subsection by regulations made under this subpart, must ensure that each levy payment is paid into a Crown Bank Account and separately accounted for. 6 Other financial provisions 21 Section 24 renumbered and repositioned (Power to request information) Renumber section 24 as section 11A and reposition it after section 11. 22 Cross-heading above section 25 replaced Replace the cross-heading above section 25 with: 1 Restriction or prohibition of import and other activities 23 Section 25 amended (Restriction of import, manufacture, development, field testing, or release) In section 25(1), delete or in accordance with Parts 11 to 16 . Replace section 25(1B) with: 1B Despite subsection (1)(b), the following departments or their agents may isolate, aggregate, multiply, breed, propagate, grow, raise, or otherwise use a new organism for the purpose of identifying, managing, or eradicating that organism: a the department responsible for administering the Biosecurity Act 1993: b any departments that are recognised by the responsible Minister under section 101(2) of that Act. In section 25(2), delete , develop . Replace section 25(6) with: 6 A person may do a thing specified in subsection (1)(a) or (b) in relation to any hazardous substance or new organism that is or has been the subject of any of the following kinds of application only if the person has applied for and been granted an approval under this Act to do the thing: a an application made under this Act if the Authority is required under Part 6 of the Agricultural Compounds and Veterinary Medicines Act 1997 (as applied by section 141R(2) ) to protect confidential information (within the meaning of section 141R(6) ) provided in support of that application that is about the hazardous substance or new organism: b an innovative medicine application: c an innovative TNP application. In section 25(7), replace section 55(3) or (4) with section 141R(1) or (2) . 24 Section 25B amended (Prohibition on storage of persistent organic pollutants) Replace the heading to section 25B with Prohibition of storage of persistent organic pollutants and exception . Repeal section 25B(2)(b). 25 Sections 25C and 25D replaced Replace sections 25C and 25D with: 25C Prohibited organisms 1 The importation, release, or development of any organism specified in Schedule 2 (other than a denewed organism) is prohibited. 2 However, the development of any new organism specified in Schedule 2 that is present in New Zealand and that the Authority considers to be a vagrant is permitted in accordance with an approval granted under section 45. 3 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 (4) , recommended to the Minister be included in that schedule: b add a new organism, or a 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 a group of organisms, but only if the organism or group was inserted by Order in Council. Guidance note See section 141 for procedural requirements with which the Minister must comply before making a recommendation under subsection (3) . 4 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; and b any likely adverse effects that may occur should the organism escape from containment would outweigh any likely beneficial effects of allowing the organism to be imported into containment. 5 The Authority, when making a recommendation under subsection (4) , 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. 6 In this section, denewed organism mean an organism that is prescribed as not a new organism in regulations made under section 140(1)(c) or a notice made under Part 5A . 7 An order made under this section is secondary legislation ( see Part 3 of the Legislation Act 2019 for publication requirements). 26 New subpart 2 heading in Part 5 inserted In Part 5, above section 26, insert: 2 Determination of new organisms and hazardous substances, definitions, etc 27 Section 26 amended (Determination of new organism or hazardous substance) Replace section 26(1) and (2) with: 1 The Authority may, on application by any person, determine either or both of the following: a whether or not an organism is a new organism: b any 1 or more taxonomic classifications, as the Authority thinks fit, for an organism or a group of organisms. 2 The determination must be published on an Internet site maintained by or on behalf of the Authority. 28 Section 27 replaced (Types of approval) Replace section 27 with: 27 Meaning of approval In this Act, approval means any of the following: a an approval to import or manufacture a hazardous substance, otherwise than into or in containment ( see sections 28A, 29, and 29AB ): b an approval to import a hazardous substance into containment or to manufacture a hazardous substance in containment ( see sections 30 and 32): c an approval to import for release or release from containment a new organism that is not a qualifying organism without controls ( see sections 34B , 35 and 38): d an approval to import for release or release from containment a qualifying organism with controls ( see section 38I) or without controls ( see sections 38 and 38I): e a conditional release approval to import for release or release from containment a new organism with controls ( see sections 38BA and 38C): f an approval to import a new organism into containment, or to develop or field test a new organism in containment ( see sections 39, 42 to 42C , and 45): g an approval to do 1 or more of the following ( see section 48): i import a hazardous substance for release or use in response to an adverse event: ii import a new organism for release or use in response to an adverse event: iii release or use a hazardous substance from containment in response to an adverse event: iv release or use a new organism from containment in response to an adverse event: v use any hazardous substance in response to an adverse event in a manner that would otherwise contravene the provisions of this Act or any regulations or any EPA notice: h an approval to do any 1 or more of the following in a special emergency ( see section 49F): i import an agricultural compound, a medicine, or a medical device for release: ii manufacture an agricultural compound, a medicine, or a medical device that is or contains a hazardous substance otherwise than in containment: iii release an agricultural compound, a medicine, or a medical device from containment: iv use an agricultural compound, a medicine, or a medical device in a manner that would contravene this Act or any regulations or any EPA notice: i an approval to tranship a hazardous substance or new organism through New Zealand ( see section 51). 29 Section 27A amended (Approvals at any taxonomic classification) In section 27A(1), replace section 27(b), (ba), (bb), or (c) with section 27(c), (d), (e), or (f) . 30 Section 28 and cross-heading replaced Replace section 28 and the cross-heading above section 28 with: 3 Approvals for hazardous substances Approvals for hazardous substances except containment approvals 28 Application for approval to import or manufacture hazardous substance 1 A person intending to import or manufacture a hazardous substance otherwise than into or in containment must, before importing or manufacturing that substance, apply under this section for, and be granted, an approval under section 28A or 29 to import or manufacture that substance. 2 However, subsection (1) does not apply to the person if— a an approval under section 28A or 29 already allows the importation or manufacture of that substance; or b the person applies under section 29A for, and is granted, an approval under section 29AB that allows the person to import or manufacture the substance and that approval is in force. 3 An application under this section must— a be in the approved form; and b contain, or be accompanied by, the information prescribed by the regulations; and c contain, or be accompanied by, a statutory declaration that verifies any of the prescribed information referred to in paragraph (b) that the regulations require to be verified by a statutory declaration. 4 An applicant under this section may withdraw the application at any time by written notice to the Authority. 31 Section 28A amended (Rapid assessment for importation or manufacture of hazardous substances) Replace section 28A(1) with: 1 The Authority may make a rapid assessment of the adverse effects of importing or manufacturing a hazardous substance if an application under section 28 to import or manufacture the substance requests that the Authority make a rapid assessment of those effects. Replace section 28A(3) to (6) with: 3 The Authority must not approve a hazardous substance under this section solely because it is satisfied of the matter in subsection (2)(ab) if it considers that the application, if approved, will result in— a significant cultural, economic, environmental, ethical, or health effects in or for New Zealand; or b significant effects for New Zealand’s international obligations; or c significant effects in an area in which the Authority lacks sufficient knowledge or expertise. 4 Sections 77 to 77B apply to any hazardous substance approved under this section. 5 The Authority must not determine the application under section 29 if the Authority decides— a to decline to make a rapid assessment under this section; or b to make a rapid assessment but not to approve the hazardous substance under this section. 6 However, nothing in this section prevents an applicant from— a withdrawing the application under section 28 before the Authority declines to make a rapid assessment or declines to approve the hazardous substance under this section; or b making a new application under section 28 . 32 Section 29 amended (Determination of applications) In section 29(1), replace any with an . After section 29(1), insert: Guidance note This section does not apply to an application for approval made under section 28 that requests that the Authority make a rapid assessment of the adverse effects of importing or manufacturing a hazardous substance ( see section 28A). 33 New sections 29A to 29AC inserted After section 29, insert: 29A Application for temporary hazardous substance approval 1 A person may apply under this section for an approval under section 29AB (a temporary hazardous substance approval ) to import or manufacture a hazardous substance for a use specified in the application if— a the person has applied under section 28 to carry out that importation or manufacture for the specified use; and b the Authority has notified the person under section 52 that the application under section 28 is complete; and c the determination of the application under section 28 is pending; and d the specified use of the hazardous substance has been lawfully authorised by at least 2 international regulators. 2 A person may not apply for a temporary hazardous substance approval if— a the person has requested, in their application under section 28 , that the Authority make a rapid assessment under section 28A; and b the Authority’s determination as to whether to make the rapid assessment or approve the hazardous substance is pending. 3 A determination relating to an application is pending if— a the applicant has not withdrawn the application; and b the application has not lapsed under section 52B ; and c the application has not been finally determined. 4 An application under this section must— a be in the approved form; and b contain, or be accompanied by, the information prescribed by the regulations; and c contain, or be accompanied by, a statutory declaration that verifies any of the prescribed information referred to in paragraph (b) that the regulations require to be verified by a statutory declaration. 5 An applicant under this section may withdraw the application at any time by written notice to the Authority. 6 The application is to be treated as withdrawn if, before the application is determined under section 29AB , the application under section 28 — a is withdrawn by the applicant; or b lapses under section 52B ; or c is determined under section 29. 29AB Determination and content of temporary hazardous substance approval 1 The Authority may grant an application under section 29A for a temporary hazardous substance approval only if— a the Authority is satisfied that the approval would have an identified benefit for New Zealand for the duration of the approval; and b controls will be imposed on the approval; and c the Authority is satisfied that, for the duration of the approval, those controls would be sufficient to manage the risks associated with the specified use for which the approval would allow the hazardous substance to be imported or manufactured. 2 Without limiting subsection (1)(b) , a temporary hazardous substance approval must include a control to the effect that the person to whom the approval has been granted may, for the duration of the approval,— a use the hazardous substance only if that use is the specified use; or b supply the hazardous substance only if the person takes all reasonably practicable steps to ensure that any resupply is only for the specified use. 3 Sections 77 to 77B apply to any hazardous substance approved under this section. 4 In this section, specified use , in relation to an approval, means the use specified in the approval. 29AC Duration of temporary hazardous substance approval A temporary hazardous substance approval expires on the earliest of the following: a the date specified as the expiry date in the approval (being a date that is no later than 4 years after the date on which the approval is granted): b when the person to whom the approval is granted withdraws the application under section 28 (the related section 28 application ) that is referred to in section 29A : c when the related section 28 application— i lapses under section 52B ; or ii is determined under section 29. 34 Section 29B amended (Applications relating to persistent organic pollutants) In section 29B(1)(b), replace environmentally sound disposal with disposal in accordance with directions issued under section 73A (environmentally sound disposal of persistent organic pollutants) . 35 Section 30 amended (Importing hazardous substances in containment) Replace the heading to section 30 with Importing or manufacturing hazardous substances into or in containment . In section 30, replace manufacture or importation of any hazardous substance in containment with importation into containment, or the manufacture in containment, of any hazardous substance . Replace section 30(c) with: c use in response to an adverse event (within the meaning of section 46 ), a special emergency declared under section 49B, or an emergency declared under any other Act; or 36 Section 31 amended (Application for hazardous substance containment approval) Replace section 31(1) to (3) with: 1 A person intending to import into containment, or manufacture in containment, any hazardous substance must, before importing or manufacturing that substance, apply under this section for, and be granted, an approval to import or manufacture that substance. 2 An application under this section must— a be in the approved form; and b contain, or be accompanied by, the information prescribed by the regulations; and c contain, or be accompanied by, a statutory declaration that verifies any of the prescribed information referred to in paragraph (b) that the regulations require to be verified by a statutory declaration. 37 Section 33 amended (Exemptions from Act for small-scale research on hazardous substances) Replace the heading to section 33 with Small-scale research on hazardous substances: exemption for use and sale . Before section 33(1), insert: Exemption Replace section 33(1)(b) with: b the use does not create or involve a declined hazardous substance; and After section 33(1), insert: Restriction on sale After section 33(2), insert: 3 In this section, declined hazardous substance — a means a hazardous substance that is the subject of— i an application for approval that is declined; or ii an approval that is revoked under section 63 ; but b does not include a hazardous substance that— i is the subject of an approval that is in force (except if the hazardous substance is prescribed for the purposes of this subparagraph); or ii is the subject of an application for a temporary hazardous substance approval that is declined (except if the hazardous substance is prescribed for the purposes of this subparagraph); or iii is the subject of a temporary hazardous substance approval that is revoked under section 63 (except if the hazardous substance is prescribed for the purposes of this subparagraph); or iv is prescribed for the purposes of this subparagraph. 4 In this section, a reference to a hazardous substance that is prescribed is a reference to a hazardous substance that is, or that belongs to a class that is, prescribed by an EPA notice issued under section 76A. 38 New subpart 4 in Part 5 inserted After section 33, insert: 4 Approvals for new organisms Importation for release or release from containment generally 33A Application required Every person intending to import for release or to release from containment any new organism must, before importation or release, apply to the Authority under section 34 or 38A for, and be granted, an approval to import or release the organism. 39 Cross-heading above section 34 replaced Replace the cross-heading above section 34 with: Importation for release or release from containment (other than conditional release) 40 Section 34 amended (Application for approval to import or release) Replace the heading to section 34 with Application for approval other than conditional release approval, etc . Replace section 34(1) with: 1 A person may apply to the Authority for an approval (other than a conditional release approval) to import for release or to release from containment a new organism. Replace section 34(2) and (3) with: 2 An application under this section must— a be in the approved form; and b contain, or be accompanied by, the information prescribed by the regulations; and c contain, or be accompanied by, a statutory declaration that verifies any of the prescribed information referred to in paragraph (b) that the regulations require to be verified by a statutory declaration. 41 Section 34A amended (Applications for conditional release and for release in respect of same new organism) Replace the heading to section 34A with Deemed section 34 application: release of new organism at expiry of conditional release approval . After section 34A(1), insert: 1A The application must— a be in the approved form; and b contain, or be accompanied by, the information prescribed by the regulations; and c contain, or be accompanied by, a statutory declaration that verifies any of the prescribed information referred to in paragraph (b) that the regulations require to be verified by a statutory declaration. 42 New section 34B inserted (Approval to release without controls: simplified transition from conditional release approval) After section 34A, insert: 34B Approval to release without controls: simplified transition from conditional release approval 1 Any person may apply to the Authority for approval under this section to release, without controls, a new organism to which a conditional release approval applies. 2 An application under this section must— a be in the approved form; and b contain, or be accompanied by, the information prescribed by the regulations; and c contain, or be accompanied by, a statutory declaration that verifies any of the prescribed information referred to in paragraph (b) that the regulations require to be verified by a statutory declaration. 3 The Authority may grant the application only if the Authority is satisfied that the criteria prescribed by an EPA notice for the purposes of this section are met. 4 If the application is granted,— a the approval takes immediate effect; and b the conditional release approval expires with immediate effect; and c the new organism may be released without controls. 5 An applicant under this section may withdraw the application at any time by written notice to the Authority. 43 Section 35 amended (Rapid assessment of risk for importation of new organisms) In the heading to section 35, after organisms , insert (other than qualifying organisms) . Replace section 35(1) with: 1 The Authority may make a rapid assessment of the adverse effects of importing a new organism (other than a genetically modified new organism) for release if an application under section 34 to import the new organism for release requests that the Authority make a rapid assessment under this section of those effects. In section 35(2)(a) and (3)(a), delete as defined in the Biosecurity Act 1993 . After section 35(5), insert: 6 This section does not apply to an application under section 34 that relates to a qualifying organism ( see section 38I(1) to (2)). 44 Section 36 amended (Minimum standards) In section 36, replace shall decline the application with must decline an application made under section 34 . 45 Section 37 heading amended (Additional matters to be considered) In the heading to section 37, after considered , insert for decision under section 38 . 46 Section 38 amended (Determination of applications to import or release) In the heading to section 38, replace to import or release with under section 34 generally . Repeal section 38(1)(b)(i). After section 38(1)(b), insert: Guidance note See section 36 (minimum standards), which sets out circumstances in which the Authority must decline the application. Repeal section 38(3) to (4). 47 New sections 38AA to 38AAC inserted After section 38, insert: 38AA Duration of section 38 approval generally 1 This section applies to an approval granted under section 38 but does not apply to an approval that is expressed to take effect when a conditional release approval expires. 2 The approval expires— a on the applicable expiry date; or b if the organism is released before the applicable expiry date, when the organism is released. 3 The applicable expiry date is the latest of the following dates: a the date that is 5 years after the date of the approval: b if an application is made under section 38AAB to extend the approval,— i the date on which the Authority determines the application if the Authority refuses it, but only if that date is after the date on which the approval would otherwise expire; or ii the date determined by the Authority if the Authority grants the application. 38AAB Application for extension of section 38 approval generally 1 This section applies to an approval to which section 38AA applies. 2 On an application made by any person before the date on which the approval would otherwise expire, the Authority may extend the approval if the approval— a has not been extended before; or b has been extended fewer than 3 times. 3 Section 52(5) does not apply in relation to the application and, accordingly, the date on which the application is made is the date on which it is lodged with the Authority (whether or not it is complete, within the meaning of section 52(3) ). 4 The application must— a be in the approved form; and b contain, or be accompanied by, the information prescribed by the regulations; and c contain, or be accompanied by, a statutory declaration that verifies any of the prescribed information referred to in paragraph (b) that the regulations require to be verified by a statutory declaration. 5 The approval continues in force until the Authority determines the application. 6 However,— a subsection (5) does not reduce the period for which the approval would otherwise remain in force under section 38AA ; and b if the Authority grants the application, the approval continues in force until the date that the Authority determines. 7 If the Authority grants the application, the date determined by the Authority must not be later than 5 years after the date on which the approval would have expired but for subsections (5) and (6)(b) . 38AAC Notification of release in accordance with section 38 approval 1 This section applies to an approval to import a new organism for release, or to release a new organism from containment, that is granted under section 38. 2 A person who releases an organism in accordance with the approval must notify the Authority within 1 month after the date of release. 3 A person is not required to notify the Authority under this section if the Authority waives the requirement for notification. Guidance note See section 20(4) , which requires the Authority to record in the register kept under section 20 whether or not it has been notified under this section or has waived the requirement for notification. 48 Section 38A amended (Application for approval to import or release new organism with controls) Replace section 38A(2) and (3) with: 2 An application under this section must— a be in the approved form; and b contain, or be accompanied by, the information prescribed by the regulations; and c contain, or be accompanied by, a statutory declaration that verifies any of the prescribed information referred to in paragraph (b) that the regulations require to be verified by a statutory declaration. 49 Section 38B amended (Application under section 34 may be treated as application under section 38A) In section 38B, delete , and sections 38A, 38BA, 38C, and 53(1)(ab) apply accordingly . 50 Section 38BA amended (Rapid assessment of risk for importation or release of new organisms with controls) Replace section 38BA(1) with: 1 The Authority may make a rapid assessment of the adverse effects of importing for release, or releasing from containment, a new organism (other than a genetically modified organism) if an application under section 38A in respect of the new organism requests that the Authority make a rapid assessment of those effects. In section 38BA(2)(a), delete as defined in the Biosecurity Act 1993 . 51 Section 38E amended (Duration of conditional release approval) Replace section 38E(1) with: 1 A conditional release approval that expressly states that it does not expire expires on the close of the latest date on which the controls imposed on the approval expressly expire. Replace section 38E(2)(c) with: c the close of the latest date on which the controls imposed on the approval expressly expire. After section 38E(2), insert: 3 Despite anything else in this section, if an application is made under section 38F to extend a conditional release approval, the date on which the conditional release approval expires is,— a if the Authority refuses the application, the date on which the Authority determines the application, but only if that date is after the date on which the approval would otherwise expire; or b if the Authority grants the application, the date determined by the Authority. 52 Section 38F replaced (Consequences of expiry of conditional release approval) Replace section 38F with: 38F Application for extension 1 On an application made by any person before the date on which a conditional release approval would otherwise expire, the Authority may extend the approval if the approval— a has not been extended before; or b has been extended fewer than 3 times. 2 Section 52(5) does not apply in relation to the application and, accordingly, the date on which the application is made is the date on which it is lodged with the Authority (whether or not it is complete, within the meaning of section 52(3) ). 3 The application must— a be in the approved form; and b contain, or be accompanied by, the information prescribed by the regulations; and c contain, or be accompanied by, a statutory declaration that verifies any of the prescribed information referred to in paragraph (b) that the regulations require to be verified by a statutory declaration. 4 The approval continues in force until the Authority determines the application. 5 However,— a subsection (4) does not reduce the period for which the approval would otherwise remain in force under section 38E; and b if the Authority grants the application, the approval continues in force until the date that the Authority determines. 6 If the Authority grants the application, the date determined by the Authority must not be later than 5 years after the date on which the approval would have expired but for subsections (1) and (5)(b) . 53 Section 38G amended (Review of controls on conditional release approval) Replace section 38G(1) and (2) with: 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 97A, review the controls that it has imposed on the conditional release approval. 1A Following the review, the Authority may— a amend a control so that it better meets the objective of the control; or b amend or replace a subject-to-review control if the amendment or replacement is consistent with the potential consequences of the review identified in the subject-to-review control; or c remove a control requiring the disposal of the new organism to which the approval applies if the Authority considers that the control is not necessary to prevent any adverse effect on human health or safety or the environment; or d impose, amend, or replace a control requiring the disposal of the new organism to which the approval applies if the Authority considers that— i imposing, amending, or replacing the control is necessary to prevent any adverse effect on human health or safety or the environment; or ii amending or replacing the control (if applicable) will not increase the likelihood of any adverse effect on human health or safety or the environment. 1B Nothing in subsection (1A)(d) limits the discretion of the Authority under subsection (1A)(a) or (b) . 2 An application under this section must— a be in the approved form; and b contain, or be accompanied by, the information prescribed by the regulations; and c contain, or be accompanied by, a statutory declaration that verifies any of the prescribed information referred to in paragraph (b) that the regulations require to be verified by a statutory declaration. 2A An applicant under this section may withdraw the application at any time by written notice to the Authority. In section 38G(3), replace section 67A with section 73C . After section 38G(3), insert: 4 In this section, subject-to-review control means a control that includes a review requirement that specifies the circumstances in which the control is to be reviewed and the potential consequences of the review. 54 Section 38I amended (Assessment of applications for release of qualifying organisms) Before section 38I(1), insert: Rapid assessment After section 38I(1), insert: 1A An approval granted under this section is not an approval— a to use a qualifying medicine or qualifying medical device until the medicine or device 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. Before section 38I(3), insert: Determination of whether medicine, etc, is qualifying medicine, etc In section 38I(3), replace qualifying organism is or is contained in a qualifying medicine or a qualifying veterinary medicine with medicine, medical device, or veterinary medicine that is or contains a new organism is a qualifying medicine, qualifying medical device, or qualifying veterinary medicine . In section 38I(3)(a), after veterinary medicine , insert , or the intended purpose of the medical device, . In section 38I(3)(b), replace qualifying with new . After section 38I(3), insert: Guidance note See paragraph (b) of the definitions of qualifying medical device, qualifying medicine, and qualifying veterinary medicine in section 2(1). See also definition of qualifying organism in section 2(1). In section 38I(4), replace qualifying organism is or is contained in a qualifying medicine or a qualifying veterinary medicine with medicine, medical device, or veterinary medicine that is or contains a new organism is a qualifying medicine, qualifying medical device, or qualifying veterinary medicine . In section 38I(4)(a) and (b), replace qualifying organism with new organism . After section 38I(4)(a), insert: aa any effect of the medical device or new organism on the person in, on, or for whom the device is being used (within the meaning of the Medicines Act 1981): Replace section 38I(5) with: 5 In this section,— medical device has the same meaning as in section 3A of the Medicines Act 1981 medicine means a medicine or new medicine within the meaning of section 3 of the Medicines Act 1981 veterinary medicine has the same meaning as in section 2(1) of the Agricultural Compounds and Veterinary Medicines Act 1997. 55 Section 38J replaced (Procedure for assessing and approving application by responsible chief executive) Replace section 38J with: 38J Procedure for assessing and approving application by responsible chief executive 1 This section applies if the Authority has delegated to the responsible chief executive its power under section 38I(1) to assess and approve an application that relates to a qualifying organism. 2 The responsible chief executive must be paid the charge fixed by the Authority for the assessment and approval of the application. 3 The responsible chief executive must determine whether the medicine is a qualifying medicine, the medical device is a qualifying medical device, or the veterinary medicine is a qualifying veterinary medicine, as the case may be. 4 If the responsible chief executive is satisfied that the medicine is a qualifying medicine, the medical device is a qualifying medical device, or the veterinary medicine is a qualifying veterinary medicine, the responsible chief executive may, with or without controls, approve the importation for release, or the release from containment, of the qualifying organism. 56 Section 38K amended (Controls) In section 38K(1)(a), after qualifying medicine , insert , qualifying medical device, . In section 38K(1)(b), replace the qualifying medicine or with or using the qualifying medicine, qualifying medical device, . In section 38K(1)(c), replace the qualifying medicine or with or use the qualifying medicine, qualifying medical device, . Replace section 38K(1)(d) with: d controls concerning the persons in relation to whom the qualifying medicine or qualifying medical device may be administered or used: 57 Section 38L amended (Review of controls for qualifying organisms) Replace section 38L(2) with: 2 An application under this section must— a be in the approved form; and b contain, or be accompanied by, the information prescribed by the regulations; and c contain, or be accompanied by, a statutory declaration that verifies any of the prescribed information referred to in paragraph (b) that the regulations require to be verified by a statutory declaration. 2A An applicant under this section may withdraw the application at any time by written notice to the Authority. In section 38L(3), replace section 67A with section 73C . 58 Section 39 amended (Importation or development of new organisms in containment) Replace the heading to section 39 with Importation into, or development or field testing in, containment . In section 39(1), replace importation, development, or field testing of any new organism into containment with importation of any new organism into containment, or the development or field testing of any new organism in containment, . In section 39(1)(c), replace in an emergency with in response to an adverse event . 59 Section 40 amended (Application for containment approval for new organisms) Replace section 40(2) and (3) with: 2 To avoid doubt, an application under this section for approval to develop a new organism that is specified in Schedule 2 and that the Authority considers to be a vagrant may be made whether or not the new organism is present in New Zealand. Guidance note However, importing a new organism specified in Schedule 2 is prohibited under section 25C . 3 An application under this section must— a be in the approved form; and b contain, or be accompanied by, the information prescribed by the regulations; and c contain, or be accompanied by, a statutory declaration that verifies any of the prescribed information referred to in paragraph (b) that the regulations require to be verified by a statutory declaration. 60 Section 42 amended (Rapid assessment of adverse effects for development of genetically modified organisms) Replace section 42(1) with: 1 The Authority may make a rapid assessment of the adverse effects of developing a genetically modified organism in containment if an application under section 40 to develop the organism in containment requests that the Authority make a rapid assessment under this section of those effects. After section 42(2), insert: 3 This section does not apply in relation to the development in containment of a genetically modified organism— a that is a new organism specified in Schedule 2; and b that the Authority considers to be a vagrant. 61 Section 42A amended (Rapid assessment of projects for low-risk genetic modification) Repeal section 42A(1). In section 42A(2), replace 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 with a specified application that requests the Authority to make a rapid assessment of the adverse effects of carrying out the project to which the application relates, the Authority may make a rapid assessment of those effects . After section 42A(3), insert: 4 This section does not apply in relation to the development in containment of a genetically modified organism— a that is a new organism specified in Schedule 2; and b that the Authority considers to be a vagrant. 5 In this section, specified application , in relation to a project, means an application under section 40 to develop a new organism in containment as part of a project. 62 Section 42B amended (Rapid assessment of adverse effects for importation of genetically modified organisms into containment) Replace section 42B(1) with: 1 The Authority may make a rapid assessment of the adverse effects of importing a genetically modified organism into containment if an application under section 40 to import the organism into containment requests that the Authority make a rapid assessment under this section of those effects. 63 Section 42C replaced (Rapid assessment of adverse effects for development in containment, etc, of certain new organisms) Replace section 42C with: 42C Rapid assessment of adverse effects of importing, developing, or field testing (other than genetically modified organism) 1 The Authority may make a rapid assessment of the adverse effects of importing a new organism (other than a genetically modified organism) into containment, or of developing or field testing a new organism (other than a genetically modified organism) in containment, if an application under section 40 to import the organism into containment, or to develop or field test the organism in containment, requests that the Authority make a rapid assessment under this section of those effects. 2 If the Authority is satisfied that the importation, development, or field testing meets the prescribed criteria for low-risk importation, development, or field testing, the Authority may— a approve the application; and b impose any controls that the Authority thinks fit for each of the matters specified in Part 2 of Schedule 3. 3 The prescribed criteria for low-risk importation, development, or field testing are the criteria prescribed by an EPA notice for the purposes of this section. 4 This section does not apply in relation to the development in containment of a new organism— a that is specified in Schedule 2; and b that the Authority considers to be a vagrant. 64 Section 43 amended (Additional matters to be considered when application made for developing new organisms in containment) In section 43, insert as subsection (2): 2 If the application is for approval to develop a new organism in containment that is specified in Schedule 2 and that the Authority considers to be a vagrant, the Authority must also have regard to any adverse effects of the development of the organism and of any of its offspring, progeny, or descendants. 65 Section 44 amended (Additional matters to be considered on applications for importing and field testing of organisms) After section 44(b), insert: c the ability of any heritable material arising from the organism to escape from containment if it is a genetically modified organism. In section 44, insert as subsection (2): 2 The Authority, when making a decision under section 45 on the application, may have regard to the ability of any heritable material arising from the organism to escape from containment if it is not a genetically modified organism. 66 Section 45 amended (Determination of application) Replace section 45(1) with: 1 After considering any application for approval made under section 40, the Authority (if the application is not approved under section 42, 42A, 42B, or 42C ) may, in its discretion, approve the application if— a the application is for 1 or more of the purposes specified in section 39(1); and b the Authority is satisfied, after taking into account all the effects of the organism and any inseparable organism (including the matters referred to in section 43 or 44, as applicable), that the beneficial effects of having the organism in containment outweigh the adverse effects of the organism and any inseparable organism; and c the Authority is satisfied— i that the organism can be adequately contained; and ii that, in the case of a new organism that is specified in Schedule 2 and that the Authority considers to be a vagrant, the organism and any offspring, progeny, or descendants of the organism will not escape from containment. 1A Without limiting the circumstances in which the Authority may, in its discretion, decline the application, the Authority must decline the application if any of the matters set out in subsection (1)(a), (b), and (c) are not met. In section 45(4), replace In taking into account the adverse effects of the organism under subsection (1)(a)(ii) with In determining the adverse effects of the organism for the purposes of subsection (1)(b) . 67 New section 45AA inserted (Controls required for development of prohibited organism that is vagrant) After section 45A, insert: 45AA Controls required for development of prohibited organism that is vagrant 1 This section applies to an approval under section 45 to develop in containment a new organism that is specified in Schedule 2 and that the Authority considers to be a vagrant. 2 The approval must include controls— a to ensure that, if the organism is not already in a containment facility, the organism is placed in and contained in a containment facility; and b to restrict the number or quantity of offspring, progeny, or descendants that may be in containment at the facility; and c to ensure that, after the end of the development of the organism, the organism and any offspring, progeny, or descendants resulting from that development continue to be in containment in a containment facility or are disposed of. 68 Section 46 and cross-heading replaced Replace section 46 and the cross-heading above section 46 with: 5 Emergencies and other adverse events Use of hazardous substances and new organisms in response to adverse events 46 Definition of adverse event For the purposes of sections 46A to 49 , adverse event means— a a state of emergency declared under the Civil Defence Emergency Management Act 2002; or b an emergency within the meaning of section 6 of the Fire and Emergency New Zealand Act 2017; or c a hazardous substance or new organisms emergency declared under Part 9; or d a marine oil spill within the meaning of section 281 of the Maritime Transport Act 1994; or e the arrival or establishment in New Zealand of an organism that is an unwanted organism. 46A Adverse event, etc, must be foreseeable A person may make an application under section 47, and be granted an approval under section 48, for the importation, release, or use of a hazardous substance or new organism in connection with an adverse event only if both of the following are foreseeable: a the adverse event: b the release or use (as the case may be) in response to the adverse event. Guidance note However, see section 49 . 69 Section 47 amended (Application for approval to use a hazardous substance or new organism in an emergency) Replace the heading to section 47 with Application for approval . In section 47(1)(a) and (b), replace release in an emergency with release or use in response to an adverse event . In section 47(1)(c) to (e), replace in an emergency with in response to an adverse event . In section 47(1), replace shall with must . Replace section 47(2) and (3) with: 2 An application under this section must— a be in the approved form; and b contain, or be accompanied by, the information prescribed by the regulations; and c contain, or be accompanied by, a statutory declaration that verifies any of the prescribed information referred to in paragraph (b) that the regulations require to be verified by a statutory declaration. 70 Section 48 amended (Determination of applications) Replace section 48(1)(a) with: a the substance or organism is not necessary for release or use in response to an adverse event; or Replace section 48(2) with: 2 When approving an application under section 47, the Authority must impose the following controls: a that the organism or substance concerned only be released or used for a specified type of adverse event: b that the organism or substance may only be released or used if the adverse event is dealt with in accordance with a specified plan that includes— i the measures that must be taken to avoid, remedy, or mitigate any actual or potential adverse effects from the release or use of that substance or organism; and ii the requirements for disposing of the hazardous substance (if applicable) and any waste products; and iii the requirements for eradication or control of the new organism (if applicable). 71 Section 49 replaced (Exemptions from provisions of Act in emergencies) Replace section 49 with: 48A Release and use in response to adverse event involving unwanted organism 1 This section applies to an approval under section 48 that authorises any 1 or more of the following activities (the regulated response activities ) in response to an adverse event that is the arrival or establishment in New Zealand of an unwanted organism: a the release of any hazardous substance from containment in response to the adverse event: b the release of any new organism from containment in response to the adverse event: c the use of any hazardous substance in response to the adverse event in a manner that would otherwise contravene the provisions of this Act or any regulations or any EPA notice. 2 A regulated response activity is authorised in response to the arrival or establishment in New Zealand of the unwanted organism only after the relevant chief executive gives notice in the Gazette stating that the activity is necessary for 1 or more of the following purposes: a minimising the impact of the organism on natural and physical resources, human health, and overseas market access for New Zealand products: b controlling the spread of the organism: c reducing the geographical distribution of the organism: d eradicating the organism. 3 The relevant chief executive must arrange for that notice to be published, as soon as practicable after it has been published in the Gazette , on an Internet site maintained by or on behalf of the department of State responsible for the administration of the Biosecurity Act 1993. 4 In this section, relevant chief executive means the chief executive of the department of State that is responsible for the administration of the Biosecurity Act 1993. 49 Exemption from provisions of Act for response to adverse event 1 Nothing in this Act applies to any hazardous substance or new organism that is required for release or use in responding to an adverse event if the adverse event or the release or use of the substance or organism in the adverse event was not foreseeable. 2 This section is subject to section 25C and sections 49A to 49L. 72 Cross-heading above section 49A amended In the cross-heading above section 49A, replace and medicines with , medicines, and medical devices . 73 Section 49A amended (Interpretation) In section 49A, replace the definition of adverse event with: adverse event includes, but is not limited to, an adverse event within the meaning of section 46 In section 49A, definition of interested government agency , replace or medicine with , medicine, or medical device . In section 49A, insert in its appropriate alphabetical order: medical device means a medical device (as defined in section 3A of the Medicines Act 1981) that is or contains a hazardous substance or new organism 74 Section 49C amended (Application of sections 49D to 49K) In section 49C(b), replace or medicine with , medicine, or medical device . 75 Section 49D amended (Application for approval to use agricultural compound or medicine in special emergency) In the heading to section 49D, replace or medicine with , medicine, or medical device . In section 49D(2)(a), replace or medicine for release with , medicine, or medical device for release . In section 49D(2)(b), replace or medicine that is with , medicine, or medical device that is or contains . In section 49D(2)(c), and (d) and (3)(b), replace or medicine with , medicine, or medical device . 76 Section 49E amended (Contents of application) In section 49E(2)(a), (b), (e), (i), and (j), replace or medicine with , medicine, or medical device in each place. In section 49E(2)(c) and (g), replace use of the agricultural compound or medicine with release or use of the agricultural compound, medicine, or medical device . In section 49E(2)(f), replace or medicine have been approved for use with , medicine, or medical device has been approved for release or use . 77 Section 49F amended (Determination of applications) In section 49F(3)(a), replace or medicine is not necessary for use with , medicine, or medical device is not necessary for release or use . 78 Section 49G amended (Controls attaching to approval of application) In section 49G, replace or medicine may be released with , medicine, or medical device may be released or used . In section 49G(a), replace use of the agricultural compound or medicine with release or use of the agricultural compound, medicine, or medical device . In section 49G(b), replace or medicine with , medicine, or medical device in each place. 79 Section 49H amended (Notification or publication of approval of application) In section 49H(2)(b), replace use of the agricultural compound or medicine with release or use of the agricultural compound, medicine, or medical device . 80 Section 49I amended (Effect of approval of release) In section 49I(1), replace or medicine with , medicine, or medical device in each place. 81 Section 49L amended (Rapid assessment and approval of other hazardous substances in special emergencies) In section 49L(2), replace or a medicine with , a medicine, or a medical device . 82 Section 50 and cross-heading repealed Repeal section 50 and the cross-heading above section 50. 83 Cross-heading above section 51 replaced Replace the cross-heading above section 51 with: 6 Transhipment through New Zealand 84 Section 51 amended (Transhipment of substances and organisms) Before section 51(1), insert: Act not applicable to approved transhipment In section 51(1), replace shall apply with applies . Replace section 51(2) with: Restriction on transhipment 2 A person must apply for, and be granted, an approval under this section before they tranship a hazardous substance or new organism through New Zealand. Application 3 An application under this section must— a be in the approved form; and b contain, or be accompanied by, the information prescribed by the regulations; and c contain, or be accompanied by, a statutory declaration that verifies any of the prescribed information referred to in paragraph (b) that the regulations require to be verified by a statutory declaration. Withdrawal of application 4 An applicant under this section may withdraw the application at any time by written notice to the Authority. Determination of application 5 The Authority— a must decline an application made under this section for approval to tranship any new organism specified in Schedule 2; and b may, within any period determined in accordance with the regulations,— i decline an application made under this section for approval to tranship any hazardous substance or new organism that the Authority considers 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 an application made under this section with any controls that the Authority thinks fit. 85 Sections 52 to 53C and cross-heading above section 52 replaced Replace sections 52 to 53AA and the cross-heading above section 52 with: 7 Procedure relating to applications, etc, and to decisions Completeness check 52 Notification that application is complete or incomplete 1 The Authority must, in writing and within the prescribed period, notify an applicant for an approval, a review, or a reassessment under this Part as to whether their application is complete. 2 The prescribed period is the period that— a starts on the first working day after the application is lodged; and b ends on the day that is determined in accordance with the regulations. 3 An application is complete only if— a the application is in the approved form; and b the application contains, or is accompanied by, any prescribed information that the regulations require to be contained in or accompany the application; and c the application contains, or is accompanied by, a statutory declaration that verifies any of the prescribed information referred to in paragraph (b) that the regulations require to be verified by a statutory declaration; and d any charge fixed by the Authority under section 21 for carrying out the completeness check has been paid to the Authority; and e any charge fixed by the Authority under section 21 for assessing and determining the application that the Authority requires to be paid before commencing the assessment has been paid to the Authority. 4 This section does not apply to an application that is made by the chief executive of the Authority. 5 An application is not to be treated for any purpose under this Act as having been made or received by the Authority until the day on which the Authority notifies the applicant that the application is complete. 6 In this section and in section 52A , applicant does not include the chief executive of the Authority. 52A Return of incomplete application 1 When the Authority notifies an applicant that an application is incomplete, the Authority must give written reasons for its decision that the application is incomplete. 2 The Authority must return the incomplete application when, or soon as is reasonably practicable after, it notifies the applicant that the application is incomplete. 3 If, after an application has been returned as incomplete, the application is lodged again with the Authority, the application is to be treated as a new application. Further information 52B Request to applicant for further information 1 The Authority may, by written notice given to an applicant, request the applicant to supply any further information relating to the application that is specified in the notice. 2 If the applicant fails to comply with the request within the period determined in accordance with the regulations, the application lapses. 52C Authority may commission report, etc 1 For the purpose of assisting the Authority in performing its functions in relation to an application, a review, or a reassessment under this Part, the Authority may— a commission a report or seek advice from any person, including, for example, a review of any information provided by the applicant (if any); or b obtain any relevant information from any source on the substance or organism that is the subject of the application, review, or reassessment. 2 If the Authority receives information under this section, the Authority must give written notice to each of the following that the information is available for inspection: a the applicant (if any): b every person who made a submission on the application, review, or reassessment in response to public notification or consultation under section 53 or 53A . 3 However, the Authority is not required to give notice relating to information that has been withheld in accordance with section 9(2)(b) of the Official Information Act 1982. 4 A notice under this section must be given within a period that is determined in accordance with the regulations before— a the Authority determines the application or makes a decision on the review or reassessment; or b any hearing of the application, review, or reassessment commences. 5 If the Authority requests a report, advice, or any other information under this section, it may postpone, for a period that it considers is reasonable,— a its determination of the application or decision on the review or reassessment; or b any hearing of the application, review, or reassessment. 6 However, the Authority may postpone its determination or decision, or any hearing, only if it considers that the requested information relates to an area in which it lacks sufficient knowledge or expertise. Notification and consultation 53 Public notification of applications, etc (except if approved under rapid assessment provisions) Applications, etc, that Authority may publicly notify 1 This section applies to each of the following: Applications relating to hazardous substances a an application under section 28 for approval to import or manufacture a hazardous substance, but only if the application has not requested that the Authority make a rapid assessment under section 28A of the adverse effects of importing or manufacturing the hazardous substance: Applications, etc, relating to new organisms b an application under section 34 to import for release, or to release from containment, any new organism, but only if the application has not been approved under section 35 or 38I: c an application under section 38A for a conditional release approval for a new organism, but only if the application has not been approved under section 38BA: d an application for a review, or a decision of the Authority to conduct a review on its own initiative, under section 38G of any controls imposed on a conditional release approval: e an application for a review, or a decision of the Authority to conduct a review on its own initiative, under section 38L of any controls imposed on an approval under section 38I relating to a qualifying organism: f an application under section 40 in respect of a new organism, but only if the application has not been approved under section 42, 42A, 42B, or 42C : Applications relating to adverse events g an application under section 47 to import for release, release from containment, or use a hazardous substance or new organism in response to an adverse event: Reassessments h an application for a reassessment, or a decision of the Authority to proceed with a reassessment on its own initiative, under subpart 9 . 2 As soon as practicable after receiving the application or making the decision,— a the Authority must consider whether there is likely to be significant public interest in the application or decision (the relevant application or decision ); and b if the Authority considers that there is likely to be significant public interest in the relevant application or decision, it must publicly notify it. Timing and content of public notice 3 The Authority must ensure that any relevant application or decision that it is required to publicly notify under this section is publicly notified within any period that is determined in accordance with the regulations. 4 The public notice must state— a that any person may make a written submission on the relevant application or decision; and b a closing date for receipt of submissions by the Authority that is determined in accordance with the regulations; and c the place or Internet site maintained by the Authority where the following may be viewed: i the application (if there is any) and any related information (except to the extent that any information in the application or in the related information is withheld in accordance with the Official Information Act 1982 or this Act); and ii the summary of the effects of the hazardous substance or new organism referred to in section 141R(5)(a) (if applicable); and d the address for service of the Authority and (if there is an applicant) the applicant, except if that address is withheld in accordance with the Official Information Act 1982. Notification of Minister 5 The Authority must notify the Minister as soon as practicable after it determines that it is required to publicly notify a relevant application or decision under this section. Guidance note See section 68(1A) , which relates to the Minister’s power to call in applications with significant effects. 6 In this section, reassessment does not include— a a reassessment of a hazardous substance that is the subject of a temporary hazardous substance approval; or b a reassessment of a qualifying organism that is the subject of an approval under section 38I for the release of the organism with controls. 53A Consultation about certain applications, etc, with affected persons 1 This section applies to any matter to which section 53 applies that is not to be publicly notified under that section, and to any transhipment application, that the Authority considers will have 1 or more of the following effects: a significant cultural, economic, environmental, ethical, health, or international effects; or b significant effects in an area in which the Authority lacks sufficient knowledge or expertise. 2 The Authority must— a do everything reasonably practicable to consult all persons who, in its opinion, are likely to be directly affected by the Authority’s decision on the application, review, or reassessment; and b give those persons a reasonable opportunity to make submissions and comments to the Authority on the application, review, or reassessment; and c consider all submissions and comments received before approving or declining the application, or completing and making a decision on the review or reassessment. 3 Nothing in this section prevents the Authority from consulting any person before making a decision on the application, review, or reassessment (whether or not the Authority is required to consult under this section). 53B Notification of departments, Crown entities, and local authorities generally Application of section 1 This section applies to each of the following: a any application under this Part (except an application for a relevant review): b any decision of the Authority to proceed with a reassessment on its own initiative under subpart 9 . Requirement to notify 2 As soon as practicable after receiving the application or making the decision, the Authority must notify— a any department or Crown entity that, in the opinion of the Authority, is likely to have an interest in the application or decision; and b if that application or decision relates to a new organism,— i the Department of Conservation; and ii any local authority that, in the opinion of the Authority, is likely to have an interest in the application or decision; and c if the application or decision relates to a hazardous substance, WorkSafe. Decision on application or reassessment 3 The Authority must have particular regard to any information the Department of Conservation or WorkSafe gives to the Authority in response to notification under subsection (2)(b) or (c) before the Authority— a makes a decision on the application (except as provided by paragraph (b) ); or b completes and makes a decision on the reassessment, in the case of an application for a reassessment or a decision to proceed with a reassessment. Definition 4 In this section, relevant review means— a a review under section 38G of any controls imposed on a conditional release approval; or b a review under section 38L of any controls imposed on an approval under section 38I relating to a qualifying organism. 53C Notification of departments and Crown entities about certain reviews 1 This section applies to an application for a relevant review, or a decision of the Authority to conduct a relevant review on its own initiative, if the application or decision is not to be publicly notified under section 53 . 2 As soon as practicable after receiving the application or making the decision, the Authority must notify— a any department or Crown entity that, in the opinion of the Authority, is likely to have an interest in the application or decision; and b the Department of Conservation (but only in the case of an application for a review, or a decision to conduct a review, under section 38G of any controls imposed on a conditional release approval). 3 In this section, relevant review has the same meaning as in section 53B . 86 Section 54 amended (Submission on application) In the heading to section 54, replace application with publicly notified matter . Replace section 54(1) with: 1 Any person may make a written submission to the Authority on any matter that is publicly notified under section 53 . In section 54(3), after applicant , insert (if any) . 87 Sections 55 to 59A replaced Replace sections 55 to 59A with: Timing, etc, and notification of decisions 55 Periods for assessment and determination 1 The Authority must assess and determine an application for an approval, a review, or a reassessment under this Part within any period determined in accordance with the regulations. 2 The Authority must complete a rapid assessment under section 28A, 35, 38BA, 38I, 42, 42A, 42B, 42C , or 49F (including section 49F as applied by section 49L) within any period determined in accordance with the regulations. 56 Joint processing of related applications so heard and decided on together 1 This section applies if— a the Authority receives applications ( related applications ) in respect of hazardous substances that are, or include, related chemicals or substances; and b at least 1 of the applications is publicly notified in accordance with section 53 or required to be consulted on by section 53A ; and c the Authority considers that decisions on the applications should be made on the same date. 2 The Authority may extend a time limit that is imposed under this Act and that applies in relation to the related applications to ensure that— a they are heard (if more than 1 application is to be heard) at the same time and place; and b decisions on the applications are made on the same date. 3 However, the Authority may not extend the time limit beyond the latest date that applies in relation to the related applications. Guidance note See also sections 141K and 141L . 57 Decision to be written and copy given to applicant, etc, and submitters 1 The Authority’s decision on an application, a review, or a reassessment under this Part, including its reasons for the decision, must be recorded in writing. 2 The Authority must give a copy of the decision to— a the applicant (if any); and b any persons who have made submissions in response to any public notification or consultation under section 53 or 53A in respect of the application, review, or reassessment. 58 Decision to be publicly notified 1 The Authority must publicly notify its decision on an application, a review, or a reassessment under this Part by no later than any date determined in accordance with the regulations. 2 The Authority may withhold any information relating to a transhipment application if, in its opinion, the information could pose a risk to national safety and security. 88 Section 60 replaced (Obligation to hold hearing) Replace section 60 with: 8 Hearings 60 Decision to hold hearing 1 The Authority must hold a hearing in respect of an application, a review, or a reassessment under this Part if the Authority— a has publicly notified under section 53 , or has consulted under section 53A on, the application or (if applicable) the decision to conduct or proceed with the review or reassessment on its own initiative; and b considers that a hearing would be likely to assist it in determining or making a decision on the application, review, or reassessment. 2 For the purposes of deciding whether a hearing would be likely to assist it in determining or making a decision on the application, review, or reassessment, the Authority must take into account whether, in its opinion, a hearing would be likely to provide it with any relevant information that is additional to— a the information that has been provided by the applicant (if any), including under section 52B ; and b any submissions or comments made in response to the public notification or consultation. 3 This section does not apply in relation to any application or reassessment that is the subject of a direction of the Minister under section 68. Guidance note Under section 71, the Authority is required to inquire into any application or reassessment that the Minister has called in under section 68. Sections 60A to 61 apply in relation to the conduct of the inquiry. 60A Date of hearing and notice about hearing If a hearing in respect of an application, a review, or a reassessment is required to be held, the Authority must— a fix a date for commencement of the hearing that is no later than any date determined in accordance with the regulations; and b give notice of that fixed date and of the time and place of the hearing to each of the following: i the applicant (if any): ii any person who made a submission in respect of the application, review, or reassessment in response to the public notification or consultation under section 53 or 53A and stated that they wish to be heard. Guidance note See also — section 52C , which enables the Authority to postpone a hearing until after information requested under that section is received and requires the Authority to notify any applicants and submitters if the Authority receives information under that section; and section 56 , which allows the Authority to extend time limits applying to related applications in respect of hazardous substances so that those applications can be heard together. 60B Information obtained under section 52C Any information obtained under section 52C may be considered at any hearing that the Authority conducts. 89 Section 61 amended (Provisions relating to hearings) In the heading to section 61, replace Provisions with Other provisions . Replace section 61(1) with: 1 This section applies if the Authority is required to hold a hearing in respect of an application, a review, or a reassessment. In section 61(3), replace For the purpose of considering any application, the with The . In section 61(4), replace in relation to any such consideration and any decision on any matter with for the purposes of the hearing and the Authority’s consideration and decision on the application, review, or reassessment that is the subject of the hearing . Replace section 61(7) and (8) with: 7 The Authority must hold any hearing in respect of an application, a review, or a reassessment in public if the application, or any decision of the Authority to conduct the review or proceed with the reassessment on its own initiative, is publicly notified under section 53 . 7A The Authority must establish a procedure that is appropriate and fair in the circumstances and may— a permit cross-examination; or b permit questions in clarification; or c permit only the members of the Authority to question any person. 8 At the hearing, the applicant (if any), and any person who made a submission in response to the public notice or consultation under section 53 or 53A and stated that they wish to be heard,— a may speak (either personally or through a representative); and b may call evidence. In section 61(9), replace he or she wished with they wish . 90 New subpart 9 heading in Part 5 inserted In Part 5, after section 61, insert: 9 Reassessments 91 Section 62 amended (Grounds for reassessment of substance or organism) In section 62(1)(c), delete released with controls . After section 62(2), insert: 2A The Authority must— a record a decision under this section, including its reasons for the decision, in writing; and b give a copy of the written decision to the person who made the request; and c give public notice of the decision as soon as practicable after making the decision. Replace section 62(3) with: 3 For the purposes of subsection (1),— a an organism has previously been assessed by the Authority if— i it is the subject of a conditional release approval ( see sections 38BA and 38C); or ii it is a qualifying organism that is the subject of an approval granted under section 38I for the release of the organism with controls; or iii it is the subject of an approval granted under any of sections 42 to 42C or 45 relating to a new organism in containment; or iv it is the subject of an approval granted under section 48; or v it is the subject of a decision of the Minister under section 73 to grant an approval under any of sections 38BA, 38C, 38I, 42 to 42C , 45, and 48; and b a hazardous substance has previously been assessed by the Authority if it is the subject of— i an approval granted under any of sections 28A, 29, 29AB , 32, and 48; or ii a decision of the Minister under section 73 to grant an approval under any of those sections. 92 New section 62A inserted (Authority may proceed with reassessment) After section 62, insert: 62A Authority may proceed with reassessment 1 The Authority may, on an application made by any person or on its own initiative, proceed with— a either of the following after making a decision under section 62(2): i a full reassessment of a hazardous substance or new organism under section 63 : ii a modified reassessment of a hazardous substance or new organism under section 63A; or b a modified reassessment of a hazardous substance under section 63C or 63D. 2 However, the Authority may proceed with a modified reassessment only if the Authority is satisfied that the preconditions specified in section 63A, 63C, or 63D (as the case may be) are met. 3 An application under this section must— a be in the approved form; and b contain, or be accompanied by, any prescribed information that the regulations require to be contained in or accompany the application; and c contain, or be accompanied by, a statutory declaration that verifies any of the prescribed information referred to in paragraph (b) that the regulations require to be verified by a statutory declaration. 4 An applicant under this section may withdraw the application at any time by written notice to the Authority. 93 Section 63 replaced (Reassessment) Replace section 63 with: 63 Full reassessment 1 A provision specified in column 1 of the following table is to be applied to an application for a reassessment under this section of a matter specified opposite in column 2: The following table is small in size and has 2 columns. Column 1 is headed Provision to be applied. Column 2 is headed Matter. Column 1 Column 2 Provision to be applied Matter Hazardous substances 1 Section 29 Hazardous substance subject of approval under section 28A or 29 2 Section 29AB Hazardous substance subject of temporary hazardous substance approval 3 Sections 30 and 32 Hazardous substance subject of approval under section 32 New organisms 4 Sections 38BA to 38D New organism subject of conditional release approval ( see sections 38BA and 38C) 5 Sections 38I to 38K Qualifying organism subject of approval under section 38I for release with controls 6 Sections 39 and 42 to 45AA New organism in containment subject of approval under section 42, 42A, 42B, 42C , or 45 Hazardous substances and new organisms: adverse events 7 Section 48 Hazardous substance or new organism subject of approval under section 48 for release or use in response to adverse event (within the meaning of section 46 ) 2 A provision specified in column 1 of the table is to be applied— a as if a reference in that provision to an application for approval were a reference to the application for reassessment; and b with any other necessary modifications. 3 On completing a reassessment under this section, the Authority may— a decide that the approval concerned may continue (with or without any variations); or b revoke the approval concerned. 4 Nothing in this section— a prevents a person from making a new application for an approval under this Part; or b in the case of the reassessment of a hazardous substance that is the subject of a temporary hazardous substance approval, affects an application that the holder of the approval has made in respect of the hazardous substance under section 28 . 5 In this section, application for a reassessment includes a decision of the Authority to proceed with a reassessment on its own initiative. 94 Section 63A amended (Modified reassessment procedure for amendments to approvals of hazardous substances) In the heading to section 63A, delete of hazardous substances . Replace section 63A(1) and (2) with: 1 The preconditions that the Authority must be satisfied are met before proceeding with a reassessment of a hazardous substance or new organism under this section are that— a a reassessment of the hazardous substance or new organism under section 63 is not appropriate because the reassessment will involve only a specific aspect of the approval concerned; and b the amendment is not a minor or technical amendment to which section 73C applies. 2 On completing a reassessment of a hazardous substance under this section, the Authority— a may vary 1 or more of the following: i the EPA controls applying in relation to the hazardous substance: ii the description of the hazardous substance: iii the hazard classification of the hazardous substance; or b may decline to vary any of the matters referred to in paragraph (a) ; but c may not revoke an approval in respect of the hazardous substance. 2A On completing a reassessment of a new organism under this section, the Authority— a may vary or decline to vary any controls applying in relation to the new organism; but b may not revoke an approval in respect of the new organism. Repeal section 63A(3). In section 63A(6), replace The Authority may approve or decline an application for reassessment under this section as it considers appropriate after taking with In making a decision under subsection (2) or (2A) , the Authority must take . In section 63A(6)(a), replace reassessment with decision . Repeal section 63A(7) and (8). 95 Section 63B replaced (Proposal for group standard may be consulted on in same way as reassessment) Replace section 63B with: 63B Proposal for group standard may be consulted on as if part of reassessment 1 This section applies if— a the Authority decides to reassess a hazardous substance under section 63A and the application, or the decision to proceed with the reassessment on its own initiative, is not required to be publicly notified in accordance with section 53 ; and b the Authority is required to consult in accordance with section 53A on the application or the decision to proceed with the reassessment; and c the Authority proposes (whether on an application or on its own initiative) to issue, amend, or revoke a group standard that applies to the hazardous substance on similar grounds for deciding under section 62 that grounds exist to reassess the substance. 2 The Authority may consult on the following matters, in accordance with section 53A , as if they were part of the reassessment: a the proposal to issue, amend, or revoke the group standard; and b the Authority’s assessment of the matters referred to in section 96C(1)(a), (b), (d), and (e) applying in relation to the group standard (if the group standard is proposed to be issued or amended). 3 If the Authority consults in accordance with subsection (2) , section 96E does not apply. 96 Section 63C amended (Modified reassessment to change controls in other cases) In the heading to section 63C, after cases , insert relating to hazardous substances . Replace section 63C(1) with: 1 The preconditions that the Authority must be satisfied are met before proceeding with a reassessment of a hazardous substance under this section are that— a a reassessment of the hazardous substance under section 63 is not appropriate because the reassessment will involve only a specific aspect of the approval concerned; and b the amendment is not a minor or technical amendment to which section 73C applies; and c the reassessment is necessary because of a change to a hazard classification system established under section 74, controls in regulations, EPA controls, or controls under the Health and Safety at Work Act 2015. In section 63C(2), replace A reassessment under this section with On completing a reassessment under this section, the Authority . In section 63C(2)(a)(iii), replace but with or . Replace section 63C(2)(b) with: b may decline to vary any of the matters referred to in paragraph (a); but c may not revoke an approval in respect of the hazardous substance. Repeal section 63C(3). In section 63C(6), replace The Authority may approve or decline an application for reassessment under this section as it considers appropriate after taking with In making a decision under subsection (2), the Authority must take . Repeal section 63C(7) to (9). 97 Section 63D amended (Modified reassessment to align classifications) In the heading to section 63D, replace classifications with hazard classifications or controls . Replace section 63D(1) with: 1 The preconditions that the Authority must be satisfied are met before proceeding with a reassessment of a hazardous substance under this section are that— a a reassessment of the hazardous substance under section 63 is not appropriate because the reassessment will involve only a specific aspect of the approval concerned; and b the amendment is not a minor or technical amendment to which section 73C applies; and c the reassessment is necessary to change a hazard classification or control to align with— i the equivalent of a hazard classification or control that has been set by an international regulator; or ii a hazard classification or control of a related substance that was the subject of a decision of the Authority after the hazardous substance was approved by the Authority. In section 63D(2), replace A reassessment under this section with On completing a reassessment under this section, the Authority . In section 63D(2)(a)(iii), replace but with or . Replace section 63D(2)(b) with: b may decline to vary any of the matters referred to in paragraph (a); but c may not revoke an approval in respect of the hazardous substance. Repeal section 63D(3). In section 63D(4), replace The Authority may approve or decline an application for reassessment under this section as it considers appropriate after taking with In making a decision under subsection (2), the Authority must take . Repeal section 63D(5) to (7). 98 New section 63DA inserted (Modified reassessments of hazardous substances: application of sections 77 to 77B) After section 63D, insert: 63DA Modified reassessments of hazardous substances: application of sections 77 to 77B 1 This section applies if the Authority decides to vary any of the matters referred to in section 63A(2)(a) , 63C(2)(a), or 63D(2)(a) on completing a reassessment of a hazardous substance under section 63A, 63C, or 63D. 2 Section 77A applies as if the decision were an approval and, for that purpose, controls previously imposed under section 77A on the hazardous substance have effect as other specified controls under that section. 3 Section 77B applies if the hazardous substance has toxic or ecotoxic properties. 4 If the hazardous substance is the subject of an approval granted under section 28A or 29 (a specified section ), section 77 applies as if the decision were an approval granted under the specified section. 5 Nothing in this section or in section 63A, 63C, or 63D limits section 77(2)(a). 99 Section 64 replaced (Suspension of approvals during reassessment) Replace section 64 with: 64 Suspension of use, etc, during reassessment: general 1 This section applies if— a an application for a reassessment, or a decision of the Authority to proceed with a reassessment on its own initiative, has been publicly notified under section 53 ; and b the Authority has reasonable grounds to believe that there is a significant actual or imminent danger to human health or safety or to the environment from,— i in the case of the reassessment of a hazardous substance, commencing or continuing to use the substance; or ii in the case of the reassessment of a new organism, commencing or continuing the relevant activity authorised by the approval concerned. 2 The relevant activity is whichever 1 or more of the following is applicable: a importing the new organism into containment: b developing or field testing the new organism in containment: c releasing or using the new organism. 3 The Authority may, by notice in the Gazette , direct that 1 or more of the following activities is prohibited until a decision is made following the reassessment of the hazardous substance or new organism: a any use or further use of the hazardous substance: b any importation or further importation into containment of the new organism: c any development or field testing, or further development or field testing, in containment of the new organism: d any release or further release of the new organism: e any release or use, or further release or use, of the new organism in response to an adverse event (within the meaning of section 46 ). 4 The Authority must publish the notice on an Internet site maintained by or on behalf of the Authority as soon as practicable after the notice has been published in the Gazette . 5 This section does not apply if the reassessment applied for, or that the Authority has decided to proceed with on its own initiative, is the reassessment of a hazardous substance that is the subject of a temporary hazardous substance approval. 64AA Suspension of use during reassessment: temporary hazardous substance approval 1 This section applies if— a a person has applied for, or the Authority has decided to proceed on its own initiative with, a reassessment of a hazardous substance that is the subject of a temporary hazardous substance approval; and b the Authority has reasonable grounds to believe that there is a significant actual or imminent danger to human health or safety or to the environment from commencing or continuing to use the substance. 2 The Authority may, by notice in the Gazette , direct that any use or further use of the hazardous substance is prohibited until a decision is made following the reassessment of the hazardous substance. 3 The Authority must publish the notice on an Internet site maintained by or on behalf of the Authority as soon as practicable after the notice has been published in the Gazette . 100 Section 64A amended (Temporary restriction of use during reassessment) In the heading to section 64A, after use , insert , etc, . Replace section 64A(1) with: 1 This section applies if— a the Authority has publicly notified a decision under section 62(2) that grounds exist to reassess a hazardous substance or new organism; and b a reassessment of the hazardous substance or new organism has not commenced or been completed; and c the Authority has reasonable grounds to believe that there is an actual or imminent danger to human health or safety or to the environment from,— i in the case of a hazardous substance, commencing or continuing to use the substance; or ii in the case of a new organism, commencing or continuing the relevant activity authorised by the approval concerned; and d the Authority has consulted any persons who the Authority considers are likely to be affected if the Authority restricts an activity referred to in paragraph (c) . 1A The Authority may, by notice in the Gazette , restrict 1 or more of the following activities in accordance with this section: a in the case of a hazardous substance, the use of the substance: b in the case of a new organism, the relevant activity that is authorised by the approval concerned. 1B In this section, relevant activity , in relation to an approval in respect of a new organism, means whichever 1 or more of the following is applicable: a importing the new organism into containment: b developing or field testing the new organism in containment: c releasing or using the new organism. In section 64A(2)(a), replace a hazardous substance with the hazardous substance, or the carrying out of the relevant activity, . In section 64A(2)(b), after substance , insert , or the carrying out of the relevant activity, . In section 64A(3)(a), after substance , insert or the carrying out of the relevant activity . Replace section 64A(3)(b) with: b remains in force until the earliest of the following: i the date on which the Authority completes, and makes a decision on, a reassessment relating to the hazardous substance or new organism: ii the date on which the applicant (if any) withdraws the application for a reassessment: iii the date on which the Authority declines to proceed with an application (if any) for a modified reassessment relating to the hazardous substance or new organism because it is not satisfied that the preconditions for proceeding with the application are met: iv the date that is 1 year after the notice is published in the Gazette , if an application for reassessment of the hazardous substance or new organism has not been made, or if the Authority has not decided to proceed on its own initiative with a reassessment of the organism or substance, by that date. 101 Section 65 replaced (No compensation following reassessment) Replace section 65 with: 65 No compensation for certain outcomes No compensation is payable to any person for any loss arising from— a the revocation of an approval under section 63 ; or b any variation under section 63 , 63A, 63C, or 63D of any controls that attach to a hazardous substance or new organism; or c any direction given under section 64 or 64AA ; or d any restriction imposed under section 64A. 102 Section 66 amended (Requirement for disposing of substances) Replace the heading to section 66 with Prohibition on use and requirement to dispose of substances . Replace section 66(1) with: 1 This section applies if the Authority revokes an approval under section 63 in respect of a hazardous substance. 1A The Authority may issue a direction, by notice in the Gazette ,— a prohibiting the use of the substance; or b requiring the substance to be disposed of, at the owner’s expense, in accordance with the controls placed on it by the Authority and identified in the direction. 1B The prohibition on the use of the substance ceases to apply if— a an approval to import or manufacture the hazardous substance is granted under section 28A, 29, or 29AB ; or b an approval to import the hazardous substance into containment or manufacture the hazardous substance in containment is granted under section 32; or c an approval in respect of the hazardous substance is granted under section 48 or 49F. 1C The Authority must publish the direction on an Internet site maintained by or on behalf of the Authority as soon as practicable after the direction has been published in the Gazette . In section 66(2), replace subsection (1) with subsection (1A) in each place. 103 Section 66A amended, renumbered as section 73A, and repositioned (Disposal of persistent organic pollutants) In the heading to section 66A, replace Disposal with Environmentally sound disposal . Replace section 66A(1) with: 1 The Authority may issue a direction, by notice, that specifies how persistent organic pollutants must be disposed of. 1A The direction may also require persistent organic pollutants to be disposed of. 1B The Authority must ensure that any direction that it issues under this section is not inconsistent with Article 6 of the Stockholm Convention. Renumber section 66A as section 73A and reposition it after the subpart 11 heading in Part 5 (as inserted by section 113 ). 104 Sections 67 and 67A renumbered and repositioned Renumber sections 67 and 67A as sections 73B and 73C , respectively, and reposition them after section 73A (as inserted by section 103 ). 105 Section 67B amended, renumbered as section 73D, and repositioned (Revoking duplicated approvals) In the heading to section 67B, replace duplicated approvals with duplicated or spent approvals, etc . Replace section 67B(1) with: 1 The Authority may, by notice,— a revoke an approval, a deemed approval, or a group standard in respect of a substance if the Authority is satisfied that a corresponding approval (other than a deemed approval) applies that has the same or a substantially similar effect; or b revoke an approval or a deemed approval in respect of a new organism if the Authority is satisfied that the approval or deemed approval is no longer in use. After section 67B(3), insert: 4 In this section,— corresponding approval includes a group standard in respect of a hazardous substance to which this Part applies ( see sections 96AB(3) and 96B(3)) deemed approval does not include a group standard. Renumber section 67B as section 73D and reposition it after section 73C (as inserted by section 104 ). 106 Cross-heading above section 68 replaced Replace the cross-heading above section 68 with: 10 Minister’s call-in powers 107 Section 68 amended (Minister’s power to call in applications with significant effects) In the heading to section 68, after applications , insert and reassessments . In section 68(1), after application , insert or reassessment in each place. In section 68(1), replace Act with Part . Replace section 68(1A) with: 1A However, a direction under this section applies to an application or a reassessment that relates to any hazardous substances only if the application or (if applicable) the Authority’s decision to proceed with the reassessment on its own initiative is one to which section 53(5) applies. Replace section 68(3) with: 3 The Minister, in the Minister’s discretion, may include in a relevant direction that applies to an application for an approval to release a new organism from containment, or the reassessment of a new organism that is the subject of a conditional release approval, a statement that specifies what is or is not significant, in the circumstances of the case, for the purposes of applying the following in respect of the application or assessment: a in the case of an application, section 36, including as applied by section 38C(1)(a): b in the case of a reassessment, section 36, including as applied by section 38C(1)(a) (as applied by section 63 ). 108 Section 69 amended (Notification of Minister’s direction) In section 69(1), after any application , insert or reassessment . In section 69(1), replace of the application with under section 53 of the application or the Authority’s decision to proceed with the reassessment on its own initiative . In section 69(2), after application , insert or reassessment . 109 Section 70 amended (Minister may appoint persons) In section 70, after application , insert or reassessment . 110 Section 71 amended (Conduct of inquiry by Authority) In section 71(1), after approval , insert or reassessment . Replace section 71(2) with: 2 The Authority may require further information under section 52B in respect of any application or reassessment to which the direction applies. In section 71(4)(b)(i), after application , insert or reassessment . Replace section 71(3) with: 3 The Authority must give public notice of the inquiry in accordance with the regulations. 3A Without limiting subsection (3) ,— a the public notice must state that any person may make a written submission on the application or reassessment to which the direction applies; and b section 54 applies in relation to any written submission that is made in response to public notification under this section. 3B Sections 60A to 61 apply in relation to the conduct of the inquiry and for that purpose— a any reference in those sections to a hearing is to be treated as a reference to the inquiry; and b any reference in those sections to a matter that is publicly notified under section 53 is to be treated as a reference to the application or reassessment to which the direction applies; and c any reference in those sections to a submission made in response to public notification under section 53 is to be treated as a reference to a submission that is made, on the application or reassessment, in response to public notification under this section. 111 Section 72 amended (Authority to report to Minister) In section 72(1), after application , insert or reassessment . In section 72(2)(a), after approval , insert or reassessment . 112 Section 73 amended (Minister to decide application and notify decision) In the heading to section 73, after application , insert or reassessment . In section 73(1), after application , insert or reassessment in each place. In section 73(2), after applicant , insert (if any) . 113 New subpart 11 heading in Part 5 inserted In Part 5, after section 73, insert: 11 Other 114 New Part 5A inserted After section 73D (as inserted by section 105 ), insert: 5A Notices: risk species and organisms that are not new organisms 73E Definitions In this Part,— authorised maker , in relation to secondary legislation under this Part, means— a the Authority; or b a specified person who is authorised under section 73F(1)(c) to make the secondary legislation specified person means— a the chief executive of the Authority; or b a committee appointed by the Authority under clause 14 of Schedule 5 of the Crown Entities Act 2004. 73F Power to prescribe and to authorise to prescribe 1 The Authority may, by notice,— a prescribe a species, or a subspecies, an infrasubspecies, a variety, a strain, or a cultivar, as a risk species for the purposes of section 2A(1)(aa) ; or b prescribe an organism as not a new organism for the purposes of this Act; or c authorise a specified person to prescribe, by notice,— i a species, or a subspecies, an infrasubspecies, a variety, a strain, or a cultivar, as a risk species; or ii an organism as not a new organism for the purposes of this Act. Guidance note Risk species may also be prescribed by regulations made under section 140. See section 2A(1)(b). See sections 2A(2)(a)(iii) and (b)(iii) and 25C(1) and (6) in relation to the effect of an organism being prescribed as not a new organism. 2 A notice made by the Authority under this section is secondary legislation ( see Part 3 of the Legislation Act 2019 for publication requirements). 3 If a notice made by the Authority under this section authorises a specified person to prescribe any of the matters referred to in subsection (1)(c) ,— a any notice made by the specified person that prescribes those matters is secondary legislation ( see Part 3 of the Legislation Act 2019 for publication requirements); and b the notice made by the Authority must contain a statement to that effect. 4 The authorised maker may make secondary legislation under this section on the maker’s initiative or on an application by another person. 5 An application under this section must— a be in the approved form; and b contain, or be accompanied by, the information prescribed by the regulations. 73G Notification and consultation 1 Before deciding whether to make secondary legislation under this Part, the authorised maker must— a notify each of the following: i the Department of Conservation: ii any department or Crown entity that, in the opinion of the authorised maker, is likely to have an interest in the proposal or application: iii any local authority that, in the opinion of the authorised maker, is likely to have an interest in the proposal or application; and b if the authorised maker considers that making the secondary legislation (or declining an application to make it) would have 1 or more of the relevant significant effects,— i do everything reasonably practicable to consult all persons who, in its opinion, are likely to be directly affected if the secondary legislation is made; and ii give those persons a reasonable opportunity to make submissions and give comments to the authorised person on the proposal or application. 2 The relevant significant effects are— a significant cultural, economic, environmental, ethical, health, or international effects; or b significant effects in an area in which the Authority lacks sufficient knowledge or expertise. 3 Nothing in this section prevents the authorised maker from consulting any person before deciding to make, or declining an application to make, the secondary legislation (whether or not the authorised maker is required to consult under this section). 73H Decision about prescribing risk species 1 In deciding whether to prescribe a species, or any subspecies, infrasubspecies, variety, strain, or cultivar, as a risk species, the authorised maker must consider all submissions and comments received about the relevant proposal or application in response to notification and any consultation under section 73G . 2 The authorised maker may prescribe a species, or any subspecies, infrasubspecies, variety, strain, or cultivar, as a risk species, under section 73F only if the authorised maker is satisfied that,— a in the case of a species, any subspecies, infrasubspecies, variety, strain, or cultivar of that species may have the relevant adverse effects; or b in the case of a subspecies, an infrasubspecies, a variety, a strain, or a cultivar, the subspecies, infrasubspecies, variety, strain, or cultivar may have the relevant adverse effects. 3 The relevant adverse effects are adverse effects on the health and safety of people or the environment. 73I Decision about prescribing organism as not new organism In deciding whether to prescribe an organism as not a new organism, the authorised maker must consider each of the following: a whether the organism has formed a self-sustaining population in New Zealand: b whether any person is attempting to manage, control, or eradicate the organism under any Act: c all submissions and comments received about the relevant proposal or application in response to notification and any consultation under section 73G . 73J Publication of reasons The authorised maker’s reasons for deciding to make, or declining an application to make, secondary legislation under this Part must be published on an Internet site that is maintained by or on behalf of the Authority. Guidance note See section 20AA , which requires the Authority to keep a register that records matters relating to decisions under this Part. 115 Part 6 heading replaced Replace the Part 6 heading with: 6 EPA controls and notices and other matters relating to Parts 5, 6A, and 7 116 New cross-heading above section 75 inserted After section 74, insert: Controls based on hazard classification 117 New cross-heading above section 76 inserted After section 75, insert: Other controls and prescribed matters 118 Section 76 amended (Authority may prescribe controls and requirements relating to hazardous substances) Replace the heading to section 76 with Controls and requirements relating to hazardous substances and new organisms . In section 76(1), replace prescribing EPA controls that do with that does . In section 76(1)(a) to (f), (i), and (j), replace prescribe with prescribes . Replace section 76(1)(g) and (h) with: g prescribes controls for any of the following to avoid or mitigate any adverse effects on the physical or chemical nature of the environment: i any hazardous substance: ii any conditionally released new organism: iii any qualifying organism released with controls: h prescribes controls to avoid or mitigate illness or injury to people or damage to the environment or chattels from any of the following: i any hazardous substance: ii any conditionally released new organism: iii any qualifying organism released with controls: After section 76(2), insert: 2A Controls may not be prescribed under subsection (1)(h)(iii) in relation to a qualifying organism— a to avoid or mitigate illness or injury to a person from being treated with a medicine that is or contains the qualifying organism; or b to avoid or mitigate illness or injury to a person from the use in, on, or for the person of a medical device that is or contains the qualifying organism; or c to avoid or mitigate illness or injury to an animal from being treated with a qualifying veterinary medicine that is or contains the qualifying organism. 119 Section 76A amended (Authority may prescribe other matters relating to hazardous substances) Replace the heading to section 76A with Other prescribed matters relating to hazardous substances and new organisms . After section 76A(a), insert: aa prescribes the method of estimating the quantity of any organism imported or developed: Repeal section 76A(b) and (c). In section 76A(e), after substances , insert or new organisms . 120 New cross-heading above section 76B inserted After section 76A, insert: General provisions: issue and publication of EPA notices 121 Section 76C amended (Procedure for issuing EPA notices) Replace section 76C(1)(c) with: c consult the following: i any department or Crown entity that, in the opinion of the Authority, is likely to have an interest in the notice: ii any representative groups (industry or otherwise) or other persons that the Authority considers appropriate. In section 76C(2)(b), after substances , insert or new organisms . In section 76C(7), replace , (3), and (4) with and (3) . 122 New cross-heading above section 76E inserted After section 76D, insert: Hazardous substances: recognition of international regulators 123 Section 76E amended (Authority may recognise overseas bodies as international regulators) In section 76E(1), after sections 28A , insert , 29A , . 124 New cross-heading above section 77 inserted After section 76E, insert: Controls attached to hazardous substances 125 Section 77 amended (EPA controls on hazardous substances) In section 77(1), replace or section 29 with , 29, or 29AB . 126 Section 77B amended (Exposure limits for substances with toxic or ecotoxic properties) In section 77B(6), insert in their appropriate alphabetical order: environmental hazards grouping means the hazard grouping referred to as environmental hazards in the EPA notice, as currently in force, that establishes the hazard classification system and is issued under section 74 environmental medium ,— a in relation to substances with toxic properties (which have a hazard classification under the health hazards grouping), means— i air, water, and soil; or ii a surface that a hazardous substance may be deposited onto: b in relation to substances with ecotoxic properties (which have a hazard classification under the environmental hazards grouping), means— i water, soil, or sediment where these are in the natural environment; or ii a surface that a hazardous substance may be deposited onto health hazards grouping means the hazard grouping referred to as health hazards in the EPA notice, as currently in force, that establishes the hazard classification system and is issued under section 74 127 New cross-heading above section 78 inserted After section 77B, insert: Hazardous substances: codes of practice 128 Cross-heading above section 87 amended In the cross-heading above section 87, replace Transferable with Hazardous substances: transferable . 129 Cross-heading above section 95A replaced Replace the cross-heading above section 95A with: Hazardous substances: permissions 130 Cross-heading above section 96 amended In the cross-heading above section 96, replace Environmental with Hazardous substances: environmental . 131 Section 96 amended (Report on environmental user charges) In section 96(3)(f), replace section 62 with subpart 9 of Part 5 . 132 Part 6A heading amended In the Part 6A heading, after standards , insert for hazardous substances and products . 133 New subpart 1 heading in Part 6A inserted Above section 96A, insert: 1 Preliminary and general 134 New section 96AB inserted (Effect of group standards) After section 96A, insert: 96AB Effect of group standards 1 If a group standard applies to a hazardous substance or product, the substance or product must comply with the group standard. 2 However, in the case of a hazardous substance, if the hazardous substance also has an approval given under this Act, the substance may instead comply with the approval. 3 A hazardous substance to which section 96B(2)(a) applies is to be treated as having been approved by the Authority under section 29. 135 Section 96B amended (Group standards) Replace the heading to section 96B with Power to issue, amend, or revoke group standards . Replace section 96B(2)(b) and (c) with: b a hazardous substance that has been approved under Part 5: After section 96B(4), insert: Guidance note See section 73D (revoking duplicated or spent approvals, etc). After the guidance note (as inserted by subsection (3) ) after section 96B(4), insert: 4A An application under this section must— a be in the approved form; and b contain, or be accompanied by, the information prescribed by the regulations; and c contain, or be accompanied by, a statutory declaration that verifies any of the prescribed information referred to in paragraph (b) that the regulations require to be verified by a statutory declaration. 136 Section 96C amended (When group standards may be issued or amended) Repeal section 96C(1)(c) and (h) and (2). After section 96C(1)(e), insert: ea have particular regard to any information that WorkSafe gives the Authority in response to notification under section 96G ; and Replace section 96C(3) with: 3 However, the Authority may, on its own initiative, amend a group standard under section 96B without complying with subsection (1) if it considers that— a the effect of the amendment is minor; or b the amendment corrects a minor or technical error. 137 Sections 96D to 96F replaced Replace sections 96D to 96F with: 2 Notification and consultation before decision 96D Application of subpart to minor amendments This subpart does not apply in relation to a group standard that the Authority amends under section 96B on its own initiative if it considers that— a the effect of the amendment is minor; or b the amendment corrects a minor or technical error. 96E Public notification Requirement to publicly notify 1 The Authority must, if it considers that there is likely to be significant public interest, publicly notify in 1 or more public notices— a an application under section 96B to issue, amend, or revoke a group standard; and b if the Authority proposes to issue or amend a group standard (whether on an application or on its own initiative),— i the proposal; and ii the Authority’s assessment of the matters required under section 96C(1)(a), (b), (d), and (e) in relation to the group standard as proposed to be issued or amended; and Guidance note This section does not apply if section 63B applies and the Authority consults in accordance with section 63B(2) . c if the Authority proposes to revoke a group standard (whether on an application or on its own initiative), the proposal. Content of public notice 2 The public notice must state— a that any person may make a written submission on the application or proposal; and b a closing date for receipt of submissions by the Authority; and c the place or Internet site maintained by or on behalf of the Authority where the following (as applicable) may be viewed: i the application and related information (except to the extent that any information in the application or in the related information is withheld in accordance with the Official Information Act 1982 or this Act); and ii the proposal; and iii the assessment; and d the address for service of— i the Authority; and ii the applicant (if any), except if that address is withheld in accordance with the Official Information Act 1982. 3 The Authority must notify the Minister as soon as practicable after it decides to publicly notify an application or a proposal under this section. Guidance note See section 68(1A) , which (as modified by section 96M ) applies in relation to an application under section 96B and relates to the Minister’s power to call in applications with significant effects. Submissions 4 Any person may make a written submission to the Authority on any application or proposal that is notified under this section. 5 The submission— a must state the reasons for making the submission; and b may state any decision sought; and c may state whether the person making the submission wishes to be heard. 6 The Authority must forward to the applicant (if any) a copy of every submission as soon as is reasonably practicable after the Authority receives it. 96F Consultation about certain applications, etc, with affected persons 1 This section applies to any application, or any proposal of the Authority, to issue, amend, or revoke a group standard that— a is not to be publicly notified under section 96E ; and b that the Authority considers will have 1 or more of the following effects: i significant cultural, economic, environmental, ethical, health, or international effects; or ii significant effects in an area in which the Authority lacks sufficient knowledge or expertise. 2 The Authority must— a do everything reasonably practicable to consult all persons who, in its opinion, are likely to be directly affected by the Authority’s decision on the application or proposal; and b give those persons a reasonable opportunity to make submissions and comments to the Authority on the application or proposal; and c consider all submissions and comments received before making a decision on the application or proposal. 3 Nothing in this section prevents the Authority from consulting any person before making a decision on the application or proposal (whether or not the Authority is required to consult under this section). 96G Notification of departments and Crown entities The Authority must notify each of the following of any application, or proposal of the Authority, to issue, amend, or revoke a group standard: a any department or Crown entity that, in the opinion of the Authority, is likely to have an interest in the application or proposal: b WorkSafe. 3 Hearings before decision 96H Application of subpart to minor amendments This subpart does not apply in relation to a group standard that the Authority amends under section 96B on its own initiative if it considers that— a the effect of the amendment is minor; or b the amendment corrects a minor or technical error. 96I Requirement to hold hearing 1 The Authority must hold a hearing if— a it considers that a hearing would be likely to assist it in— i determining an application under section 96B; or ii deciding whether to proceed with a proposal to issue, amend, or revoke a group standard on its own initiative; and b the Authority has publicly notified or consulted on the application or proposal under section 96E or 96F . 2 For the purposes of determining whether a hearing would be likely to assist it in determining an application or in deciding whether to proceed with a proposal, the Authority must take into account whether, in its opinion, a hearing would be likely to provide it with any relevant information that is additional to the following: a the information that has been provided by the applicant (if any): b any submissions and comments made in response to the public notification or consultation. 3 This section does not apply in relation to an application that is the subject of a direction of the Minister under section 68, as applied by section 96M . Guidance note Under section 71, as applied by section 96M , the Authority is required to inquire into any application under section 96B that the Minister has called in. Sections 96J to 96L apply in relation to the conduct of the inquiry. 96J Date of hearing and notice about hearing If a hearing of the application or proposal is to be held, the Authority must give notice of the date for commencement of the hearing and of the time and place of the hearing to each of the following: a the applicant (if any): b any person who made a submission in response to the public notification or consultation and stated that they wish to be heard. Guidance note See also section 96N , which enables the Authority to postpone a hearing until after information requested under that section is received and requires the Authority to give notice to applicants and submitters if the Authority receives information under that section. 96K Consideration of report, etc, obtained under section 96N Any information obtained under section 96N may be considered at any hearing that the Authority conducts under this subpart. 96L Other provisions relating to hearings Application of section 1 This section applies if the Authority is required under section 96I to hold a hearing. Record of proceedings to be kept 2 The Authority must keep a record of all proceedings before it. Powers same as for Commission of Inquiry 3 The Authority has the same powers as are conferred on a Commission of Inquiry by the Commissions of Inquiry Act 1908. 4 Sections 4, 4B, 4D, 6, 7, 9, 11, and 12 of that Act apply accordingly. Immunities and privileges 5 The members of the Authority have, for the purposes of the hearing, and the Authority’s consideration of and decision on the application or proposal that is the subject of the hearing, the same immunities and privileges as are possessed by a District Court Judge. 6 Subsection (5) applies despite section 121 of the Crown Entities Act 2004. Summons to appear 7 Every summons to a witness to appear at a hearing must be in an approved form and be signed by the person chairing the hearing. Allowances for witnesses 8 All allowances for a witness must be paid by the party on whose behalf the witness is called. Public hearings and other matters relating to proceedings 9 The Authority must hold the hearing in public if the application or proposal is publicly notified under section 96E . 10 The Authority must establish a procedure that is appropriate and fair in the circumstances and may— a permit cross-examination; or b permit questions in clarification; or c permit only the members of the Authority to question any person. 11 At the hearing, the applicant (if any), and any person who made a submission in response to the public notice or consultation under section 96E or 96F and stated that they wish to be heard,— a may speak (either personally or through a representative); and b may call evidence. 12 If any person who has stated that they wish to be heard fails to appear at the hearing, the Authority may proceed with the hearing if the Authority considers it fair and reasonable to do so. 4 Other 96M Minister’s call-in power 1 Subpart 10 of Part 5 applies, with all necessary modifications, in relation to an application under section 96B in the same way that it applies in relation to an application under Part 5. 2 For that purpose,— a a reference in section 68(1A) to an application to which section 53(5) applies is to be treated as a reference to an application to which section 96E(3) applies; and b a reference in section 69(1) to public notice given under section 53 is to be treated as a reference to public notice given under section 96E ; and c a reference in section 71(1) to an application for approval is to be treated as a reference to an application under section 96B; and d section 96E(4) to (6) applies in relation to any written submission that is made in response to public notification under section 71(3A) , as applied by this section. 3 Sections 96J to 96L (the specified sections ) apply in relation to the conduct of an inquiry under section 71 (as applied by this section) and for that purpose— a any reference in the specified sections to a hearing is to be treated as a reference to the inquiry; and b any reference in the specified sections to a matter that is publicly notified under section 96E is to be treated as a reference to the application to which the direction of the Minister under section 68 (as applied by this section) applies; and c any reference in the specified sections to a submission made in response to public notification under section 96E is to be treated as a reference to a submission that is made on the application in response to public notification under section 71 (as applied by this section). 96N Authority may commission report, etc 1 For the purpose of assisting the Authority in performing its functions in relation to an application under section 96B or a proposal to issue, amend, or revoke a group standard on the Authority’s own initiative, the Authority may— a commission a report or seek advice from any person, including, for example, a review of any information provided by the applicant (if any); or b obtain any relevant information from any source on the substance that is the subject of the application or proposal. 2 If the Authority receives information under this section, the Authority must give written notice to each of the following that the information is available for inspection: a the applicant (if any): b every person who made a submission on the application or proposal in response to public notification or consultation under section 96E or 96F . 3 However, the Authority is not required to give notice relating to information that has been withheld in accordance with section 9(2)(b) of the Official Information Act 1982. 4 If the Authority requests a report, advice, or any other information under this section, it may postpone, for a period that it considers is reasonable,— a its determination of the application or decision on the proposal; or b any hearing of the application or proposal. 5 However, the Authority may postpone its determination or decision or any hearing only if it considers that the requested information relates to an area in which it lacks sufficient knowledge or expertise. 96O Decision to be written and copy given to applicant, etc 1 This section applies to the following decisions of the Authority: a a decision to issue, amend, or revoke a group standard under section 96B on its own initiative: b a decision on an application under section 96B: c a decision to not proceed with a proposal to issue, amend, or revoke a group standard under section 96B on its own initiative if the proposal has been publicly notified or consulted on under section 96E or 96F . 2 The Authority’s decision, including its reasons for the decision, must be recorded in writing. 3 The Authority must give a copy of the decision to the applicant and any persons who have made submissions received under section 96E or 96F . 96P Decision to be publicly notified The Authority must publicly notify each of the following decisions as soon as practicable after making the decision: a a decision of the Authority to issue, amend, or revoke a group standard under section 96B on its own initiative: b a decision of the Authority on an application under section 96B: c a decision of the Authority to not proceed with a proposal to issue, amend, or revoke a group standard under section 96B on its own initiative if the proposal has been publicly notified or consulted on under section 96E or 96F . 96Q No compensation following amendment or revocation No compensation is payable to any person for any loss arising from the amendment or revocation of a group standard under this Part. 138 Section 97 amended (Enforcement of Act) In the heading to section 97, after Act , insert in respect of hazardous substances . In section 97(1), replace The following persons shall ensure the provisions of this Act (including any controls imposed on approvals granted under this Act) are enforced in the following situations with The following provisions apply to the enforcement of the provisions of this Act (including any controls imposed by approvals granted under this Act) that relate to hazardous substances . In section 97(1)(d), (e) to (g), and (h)(i) and (iii), replace shall with must . 139 Section 97A amended (Enforcement of Act in respect of new organism) In section 97A(2), after modifications , insert ( see sections 98 and 100) . In section 97A(5), repeal the definition of unwanted organism . 140 Section 97C amended (Sharing of information between Authority and enforcement agencies) Replace section 97C(3) with: 3 In this section, enforcement agency means— a a person who is responsible for the enforcement of the provisions of this Act, as provided by section 97; or b the chief executive of the department of State responsible for the administration of the Biosecurity Act 1993; or c the New Zealand Customs Service. 141 Section 99 amended (Supervision of inspection) Replace section 99(3) with: 3 For the purposes of ensuring sufficient enforcement of the provisions of this Act (including any controls imposed by approvals granted under this Act), the Authority may— a appoint enforcement officers to enforce the provisions of this Act in such premises as the Authority thinks fit; or b authorise any chief executive of a department, Crown entity, or local authority to appoint enforcement officers to enforce the provisions of this Act in or on premises specified by the Authority. Guidance note See also section 99A . 142 New sections 99A and 99B inserted After section 99, insert: 99A Authority’s step-in power 1 This section applies if the Authority considers that— a a person specified in section 97 is not performing or exercising the person’s functions, duties, or powers relating to the enforcement of the provisions of this Act (including any controls imposed by approvals granted under this Act) that relate to hazardous substances sufficiently ( see section 99(1)); and b it is necessary or desirable that the Authority do any of the following to achieve the purposes of this Act: i perform or exercise all or any of those functions, duties, or powers in place of the person: ii intervene in the performance or exercise of all or any of those functions, duties, or powers in place of the person in a case in which the person has already performed or exercised (but not yet completed the performance or exercise of) functions, duties, or powers in respect of the case: iii assist with the performance or exercise of all or any of those functions, duties, or powers. 2 The Authority may perform or exercise, or intervene in the performance or exercise of, all or any of the functions, duties, or powers in place of the person, but only if the Authority has consulted the person about the proposal to do so. 3 The Authority may assist with the performance or exercise of all or any of the functions, duties, or powers, but only with the prior agreement of the person. 4 For the purposes of subsections (2) and (3) , the Authority may appoint enforcement officers to enforce the provisions of this Act that relate to hazardous substances in any premises that the Authority thinks fit. 5 This section does not apply in relation to any functions, duties, or powers of— a a territorial authority or its chief executive under this Act ( see sections 97(1)(h) and 101); or b a regional council or its chief executive ( see section 97(2)). 6 In this section, hazardous substance has the same meaning as in section 99(4). 99B Authority may require information for purpose of section 99A 1 The Authority may, by notice in writing given to a person specified in section 97, require the person to provide information that the Authority requires for the purpose of— a deciding the matters referred to in section 99A ; or b performing or exercising, or intervening in or assisting with the performance or exercise of, all or any functions, duties, or powers under section 99A . 2 The notice must include the reason why the Authority requires the information. 3 The person must provide the required information by the date specified in the notice. 4 This section does not apply in relation to any functions, duties, or powers of— a a territorial authority or its chief executive under this Act ( see sections 97(1)(h) and 101); or b a regional council or its chief executive ( see section 97(2)). 143 Section 109 amended (Offences) Replace section 109(1)(d)(i) with: i manufactures, imports, uses, or disposes of a hazardous substance while the use of the hazardous substance is prohibited by a direction under section 64 or 64AA ; or ia imports a new organism while the importation of the new organism into containment is prohibited by a direction under section 64 ; or ib develops or field tests a new organism while developing or field testing the new organism in containment is prohibited by a direction under section 64 ; or ic releases or uses a new organism while releasing or using the new organism is prohibited by a direction under section 64 ; or After section 109(1)(e)(vii), insert: viii any restriction imposed on an activity in respect of a new organism under section 64A; or 144 Section 109A amended (Time for filing charging document) In section 109A(1), replace 6 months with 12 months . 145 Section 109B amended (Extension of time for filing charging document) In section 109B(2) and (3)(a), (c), and (d), replace 6-month with 12-month . 146 Section 114 amended (Penalties) In section 114(1A), after section 109(1)(e)(vii) , insert or (viii) . In section 114(2), delete , or section 156(1), . 147 New subpart 1 heading in Part 10 inserted In Part 10, above section 140, insert: 1 Orders in Council 148 Section 140 amended (Regulations) Repeal section 140(1)(c) to (f), (j), (k), and (m) and (2). In section 140(1)(h), after against this Act , insert and prescribing infringement fees (not exceeding $12,000) for those offences . In section 140(1)(i), delete , and prescribing the infringement fees (not exceeding $3,000) for each infringement offence, which may be different fees for different offences . In section 140(1)(l), delete prescribing forms for the purpose of this Act that relate to new organisms and . 149 Section 140A amended (Persistent organic pollutants) Replace section 140A(1) and (2) with: 1 The Governor-General may, by Order in Council made on the recommendation of the Minister,— a amend Schedule 2A by inserting, repealing, amending, or replacing any item in Schedule 2A; or b replace Schedule 2A. 2 Before recommending the making of an Order in Council under this section, the Minister must be satisfied that— a the Order in Council would be consistent with New Zealand’s obligations under the Stockholm Convention; and b in the case of an amendment that adds a hazardous substance to Schedule 2A, that substance exhibits the characteristics of a persistent organic pollutant that are specified in the Stockholm Convention. Guidance note See section 141 for other procedural requirements with which the Minister must comply before making a recommendation under this section. 150 Section 140B repealed (Schedule 1AA may be amended or substituted) Repeal section 140B. 151 Section 141 amended (Procedure for making Orders in Council) In section 141(1), delete (other than any Order in Council or part of an Order in Council made under section 9(1), 55(6), 140(1)(i), (j), or (m), or 140B) . After section 141(1), insert: 1A Subsection (1) does not apply in respect of an Order in Council or part of an Order in Council made under— a section 9(1), 20G , or 140(1)(h), (i), or (l); or b section 140(1)(t) for the purpose of section 141R(5)(b) . 152 New subpart 2 heading in Part 10 inserted In Part 10, after section 141, insert: 2 Material incorporated by reference 153 Section 141F amended (Requirement to consult on proposal to amend or replace material incorporated by reference) After section 141F(3), insert: 3A Subparts 2 and 3 of Part 6A apply, with all necessary modifications, in relation to the proposed amendment, or replacement, of material incorporated by reference in a group standard as if the proposed amendment or replacement were an application or a proposal referred to in those subparts. Repeal section 141F(4)(a). 154 New subparts 3 and 4 of Part 10, new subpart 5 heading in Part 10, and new section 141R inserted After section 141I, insert: 3 Powers to waive, direct, and vary: supply of information and time limits 141J Waivers and directions The Authority may, on the application of a person,— a waive a requirement as to the information that the person must supply under this Act; or b give a direction as to the terms on which the person must supply information under this Act. 141K Variation of time limits generally 1 The Authority may, on the application of a person or the Authority’s own initiative, vary a time limit imposed under this Act. 2 The Authority may vary the closing date by which submissions made in response to public notification under section 53, 71, 96E, or 96M may be received only if satisfied that the specified persons— a have consented to the variation; or b have not consented to, but would not be unduly prejudiced by, the variation. 3 The specified persons are— a the applicant (if any); and b any persons whom the Authority— i is aware have made a submission in response to the public notification; or ii is satisfied are likely to make a submission in response to the public notification. 4 A time limit may be varied under this section— a to a time limit that the Authority considers is reasonable in all the circumstances; and b whether or not the time limit has expired. 141L Extension of closing date: certain international agreements 1 The Authority must extend (or further extend) the closing date by which submissions made in response to public notification under section 53 , 71, 96E, or 96M may be received if a relevant CPTPP or TPP provision applies to— a the application or other matter that is publicly notified under section 53 or 96E ; or b the application or reassessment that is the subject of the inquiry that is publicly notified under section 71 or 96M . 2 The closing date may be extended to any date that the Authority considers appropriate to give effect to the relevant CPTPP or TPP provision. 3 The Authority may extend the closing date— a on an application made by a person or on its own initiative; and b whether or not the closing date has already passed. 4 Section 141K does not apply in relation to the extension of a closing date under this section. 5 In this section, relevant CPTPP or TPP provision means— a Article 8.7.14 of the Trans-Pacific Partnership Agreement (done at Auckland on 4 February 2016) (technical barriers to trade: transparency: periods to comment on proposals); or b that provision as incorporated into the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (done at Santiago, Chile, on 8 March 2018) by Article 1.1 of that agreement. 141M Decisions under sections 141J to 141L: other The Authority must— a record a decision under any of sections 141J to 141L , including its reasons for the decision, in writing; and b give a copy of the written decision to the person (if any) who applied under that section; and c give public notice of the decision as soon as practicable after making the decision. 4 Information to which Official Information Act 1982 applies 141N Information relating to likely application 1 This section applies if a person— a supplies any information to the Authority; and b the information is likely to relate to an application under this Act; and c the relevant application has not yet been lodged with the Authority. 2 The information must be held by the Authority on behalf of that person. 3 The provisions of the Official Information Act 1982 do not apply to that information until the relevant application has been received by the Authority ( see section 52(5) ). 141O Consideration of information withheld under Official Information Act 1982 Any information withheld by any person in accordance with section 9(2)(b) of the Official Information Act 1982 may be considered by— a the Authority in reaching a decision under this Act; or b the Minister in reaching a decision under section 73 (including as applied by section 96M ). 141P Public notification: information involving trade secrets, etc, to be withheld 1 If, in the Authority’s opinion, any information that has been supplied to the Authority in respect of any application under this Act may be able to be withheld under section 9(2)(b) of the Official Information Act 1982, that information must not be released to any person when any application is publicly notified. Guidance note Sections 53 , 71, 96E, and 96M provide for public notification. 2 In this section, a reference to an application includes a reference to any of the following: a a review under section 38G or 38L, including a decision of the Authority to conduct the review on its own initiative: b a reassessment under subpart 9 of Part 5 , including a decision of the Authority to proceed with the reassessment on its own initiative: c an inquiry under section 71 (including as applied by section 96M ): d a proposal of the Authority to issue, amend, or revoke a group standard on its own initiative under Part 6A. 141Q Requests under Official Information Act 1982 involving trade secrets, etc 1 This section applies if— a the Authority receives a request under the Official Information Act 1982 to release any information held by the Authority in respect of an application under this Act; and b the information to which the request relates,— i in the Authority’s opinion, may be able to be withheld under section 9(2)(b) of the Official Information Act 1982; or ii has been classified as commercially sensitive by the person who gave the information to the Authority (the information-giver ). 2 The Authority must make all reasonable efforts to, as soon as practicable, contact and notify the information-giver that the Authority has received a request to release the information. 3 Within 10 working days after a person receives a notice under this section, the person must respond to the Authority by— a stating whether the person believes that the information should be withheld under section 9(2)(b) of the Official Information Act 1982; and b giving reasons for that belief. 4 The Authority may, in accordance with the Official Information Act 1982, release the information or withhold the information if— a the Authority has complied with subsection (2) ; and b the time limit applying under subsection (3) to the person receiving a notice has expired. 5 In this section, a reference to an application includes a reference to any of the following: a a review under section 38G or 38L, including a decision of the Authority to conduct the review on its own initiative: b a reassessment under subpart 9 of Part 5 , including a decision of the Authority to proceed with the reassessment on its own initiative: c an inquiry under section 71 (including as applied by section 96M ): d a proposal of the Authority to issue, amend, or revoke a group standard on its own initiative under Part 6A. 5 Other 141R Disclosure and use of confidential information received with certain applications Application of sections 23A to 23C of Medicines Act 1981 1 Sections 23A to 23C of the Medicines Act 1981 apply (with all necessary modifications) to the Authority (as if it were the Minister of Health) in relation to confidential information received in respect of an application made under this Act if— a the hazardous substance or new organism to which the application relates is, or has been, the subject of an innovative medicine application; and b the confidential information is about that substance or organism; and c the Minister of Health is, at the time that the Authority wants to disclose or use the information, required under section 23B of the Medicines Act 1981 to protect information provided in, or in relation to, the innovative medicine application. Application of Part 6 of Agricultural Compounds and Veterinary Medicines Act 1997 2 Part 6 of the Agricultural Compounds and Veterinary Medicines Act 1997 applies (with the necessary modifications) to the Authority (as if it were the Director-General of the Ministry for Primary Industries) in relation to confidential information received in respect of an application made under this Act if— a either or both of the following apply: i the applicant has given the Authority written advice that, within 6 months after the application under this Act (the HSNO application ) is made, the applicant intends to make an innovative TNP application in respect of the hazardous substance or new organism to which the HSNO application relates: ii the hazardous substance or new organism to which the HSNO application relates is, or has been, the subject of an innovative TNP application; and b the confidential information is about that substance or organism; and c in the case of a substance or an organism that is or has been the subject of an application referred to in paragraph (a)(ii) ), the Director-General of the Ministry for Primary Industries is, at the time that the Authority wants to disclose or use the confidential information, required under Part 6 of the Agricultural Compounds and Veterinary Medicines Act 1997 to protect information provided in support of that application. 3 Subsection (2) ceases to apply in relation to confidential information about a hazardous substance or new organism that is referred to in subsection (2)(a)(i) 6 months after the relevant date if an innovative TNP application that applies to the substance or organism is not made under the Agricultural Compounds and Veterinary Medicines Act 1997 within that 6-month period. 4 The relevant date is,— a if the application under this Act is withdrawn or is returned under section 52A because it is incomplete,— i the date on which the application is withdrawn or returned (if no new and complete application is made within 6 months after the withdrawal or return); or ii if a new and complete application is made within 6 months after the withdrawal or return and is not withdrawn, the date on which the new and complete application is determined; or iii if a new and complete application is made within 6 months after the withdrawal or return and is withdrawn, the date on which the new and complete application is withdrawn; or b in any other case, the date on which the application under this Act is determined. 5 Despite subsections (2) and (3) ,— a if the Authority is required under section 53 to publicly notify the application made under this Act, the Authority must make a summary of the effects of the hazardous substance or new organism available (in place of any confidential information contained in the application and related information); and Guidance note See section 53(4)(c)(ii) , which requires the public notice to state the place or Internet site where the summary may be viewed. b the Authority may disclose confidential information to prescribed persons or organisations or to persons or organisations within prescribed classes of persons or organisations. 6 In this section,— confidential information means information that includes either or both of the following: a trade secrets: b information with a commercial value that would, or would be likely to, be diminished by disclosure of the information prescribed means prescribed by the regulations. 155 Schedule 1AA repealed Repeal Schedule 1AA. 156 Schedule 2 amended In the Schedule 2 heading, replace 50(1)–(4) with 25C . 157 Consequential amendment related to Part 1 Amend the legislation specified in the Schedule as set out in that schedule. Consequential amendment In section 2(1), definition of qualifying new medicine , replace paragraph (b) with: b is determined under section 38I(3) of the Hazardous Substances and New Organisms Act 1996 to be a qualifying medicine