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 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).

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.

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 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.

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.