Hazardous Substances and New Organisms Act 1996
Ten problems with the Hazardous Substances and New Organisms Act 1996 (HSNO) Act have been identified:
- Section 19 limits the ability of the Environmental Risk Management Authority (ERMA) to delegate its decision making powers to those specified in s19(2). However, ERMA frequently makes a variety of relatively minor technical or administrative decisions which arguably involve an exercise of the
"decision-making power". Without the ability to delegate, significant administrative costs and time delays are involved for both businesses and regulators in making these decisions.
- There are three issues associated with the assessment of non-genetically modified new organisms (non-GMOs):
- Currently the HSNO Act does not distinguish between low-risk and other non-genetically modified new organisms as it does for genetically modified organisms (GMOs). As a result, the Act does not allow for rapid assessment (and delegation to "any person") of any application to import low-risk non-GMOs into containment, or develop them in containment, whereas it does so for applications to develop or import low-risk GMOs.
- A different situation exists for field tests in containment. Instead of allowing non-GMO field test applications to be rapidly assessed (and so delegated), these applications cannot be notified. However, non-GMO developments and imports into containment (both arguably less likely to be of significant public interest than a field-test) may be notified if ERMA, in accordance with the HSNO Act, "considers that there is likely to be significant public interest" in the application.
- Applications for conditional release (with controls) of low-risk non-GMOs are not treated consistently with applications for full release (without any controls) of low-risk non-GMOs, which may be rapidly assessed if certain statutory conditions are met. Applications for conditional release (with control) however cannot be rapidly assessed even though the concerns around the risks of such releases could be satisfactorily met by the imposition of control.
- An application to import or manufacture a hazardous substance "for release" under s28 must be publicly notified under s53, unless has been rapidly assessed and approved under s28A. However, experience has shown that many hazardous substance
"release" applications that do not meet the criteria for rapid assessment are routine and attract very few public submissions. Mandatory public notification can result in delays and costs to the applicant that are disproportionate to the risks posed or the benefits of public participation.
- Section 82(4) requires a test certifier to refuse to issue a test certificate where he or she considers on reasonable grounds that any matter does not comply with the relevant requirement. Therefore, where locations are not in full compliance with the relevant HSNO requirements, a location test certificate cannot be issued until a test certifier revisits the premises and reassesses the outstanding compliance matters. This may result in substantial additional expenses to businesses, including operations being suspended while the non-compliances are resolved, even when the non-compliance may be considered
"minor or technical".
- Section 82A(1) requires ERMA to keep and maintain a register of test certificates issued by test certifiers under the Act. The Act restricts access to the register to certain purposes. However, while s82A(4) expressly allows searches where necessary to prevent or lessen a serious and imminent threat to public or individual health and safety, searches cannot be readily undertaken by the Fire Service in particular (not an enforcement agency under the Act), or by any HSNO enforcement agency, for emergency and response planning purposes.
- Some substances with Part V specific individual approvals may also be controlled under generic group standards. Therefore, reassessment of a Part V approval may also impact on a group standard. At present there is no mechanism to account for these affected group standards, other than conducting a separate full group standard amendment process. Under the current provisions, this would require separate reassessment and group standard consultation processes with the consequent cost, potential confusion and inconsistencies.
Furthermore, while s67A the Act allows ERMA to amend a Part V approval on its own motion if it considers that the alteration is
"minor or technical", there is no equivalent provision for group standards. Such alterations to a group standard therefore require the full amendment process which is excessive for these situations.
- The HSNO Act contains limited cost recovery provisions. The Ministry of Agriculture and Forestry, the enforcement agency for new organisms under the HSNO Act, can recover the costs associated with HSNO Act containment approvals under the Biosecurity Act, because the costs primarily elate to functions empowered by the Biosecurity Act. However, costs associated with controls on newer types of release approvals (outside containment) cannot be recovered under the Biosecurity Act without recovery being empowered under the HSNO Act. As a result such costs are currently recovered by MAF's baseline funding. This legislative gap does not provide any incentives to develop an efficient monitoring system for the holders of the approvals for various releases of new organisms to minimise these costs they incur.
- Sections 147(3) and 148(b) provide for additional matters relating to the effectiveness of the HSNO Act that ERMA must include in its Statement of Intent (SOI) and annual report. Experience has shown that this involves significant repetition of information already provided in a more comprehensive way elsewhere in the SOI or in ERMA's annual monitoring report, which is a requirement of the annual output agreement with the Minister and is publicly available. The duplication required by these sections results in unnecessary costs being incurred for no additional value, and diverts scarce resources away from other regulatory activities.
- Under section 82C, ERMA is currently empowered to revoke on certain grounds approved filler and handler test certificates issued by test certifiers. . However the Authority cannot revoke other types of test certificates, primarily location and stationary container test certificates, or revoke certificates when criteria for which the certificate was issued are no longer met by the certificate holder.
- Responsibility for enforcement of the HSNO Act requirements for new organisms and hazardous substances falls onto separate agencies (MAF and primarily DoL, respectively). Considerable efforts have therefore gone into aligning enforcement by these two agencies under the HSNO and Biosecurity Acts, and under the HSNO and Health and Safety in Employment Acts, respectively. However, inconsistencies remain in the respective statutory timeframes to lay information under these pair of Acts. These inconsistencies create problems in the use of the enforcement provisions of these Acts, leading to the HSNO enforcement provisions being underused.
Objectives
The overall policy objective is to ensure that the policy intent of the HSNO regulatory frameworks can be implemented and administered in an efficient manner that eliminates unnecessary compliance costs and minimises necessary compliance costs.
Preferred Options
- It is proposed to remove the specific limitation on the delegation of "decision-making powers" in s19(1)(b), while retaining the specific delegations listed in 19(2) in their current form (along with the additional delegations proposed below). This will enable ERMA to delegate technical/administrative decision-making powers to its Chief Executive, other agency staff or other persons, while retaining significant delegations in the form expressly allowed in the Act. The variety of technical/administrative decisions is such that their delegation cannot be readily covered by either a generic statement in s19(2) or a list in a Schedule of delegations. In accordance with standard legal principles, ERMA would still retain the ultimate responsibility for any delegation. It would therefore have to take all the usual precautions when considering when, to whom, and on what conditions, a delegation should be made, and would also continue to monitor the delegations it makes.
Such amendment will provide ERMA with greater flexibility and will enable greater efficiencies for both it and industry in making decisions on these matters.
- It is proposed to:
- amend the HSNO Act to enable the rapid assessment of applications to import into containment, develop in containmentation into containment, field-testing in containment, and conditionally release low-risk non-genetically modified new organisms, including the ability to delegate these rapid assessments (consistent with existing rapid assessments), and the provision or development of the appropriate criteria for rapid assessment; and
- amend section 53 of the Act to give ERMA the discretion to publicly notify any application to field-test a non-genetically modified new organism and to not be required to notify an application to conditionally release a non-genetically modified new organism, when that application has been rapidly assessed.
This option will improve consistency in how applications are processed by enabling applications to import, develop, or field-test non-GMOs in containment to be treated consistently with each other and with applications to import or develop low-risk GMO in containment (in terms of rapid assessment of low risk organisms and the discretionary notification of other applications); and by enabling applications for conditional release of low-risk non-GMOs to be treated consistently with applications for full release of low-risk non-GMOs.
The proposal will reduce application costs and shorten application times for industry, where pre-determined conditions set in the Act or in regulations are met. In doing so, these amendments will ensure the extent of assessment and the balance between risk and cost/benefits is appropriate for different application types and match the risks posed by non-GMOs, thereby ensuring sufficient assessment while minimising any unnecessary regulation.
Some distinction will remain between non-GMO and GMO field tests. Rapid assessment is not available for any GMO field test applications and all GMO field-test applications must be publicly notified. The proposed discretionary notification of other higher risk non-GMO field-test applications (not possible at present) will be on the same statutory basis as other discretionary notifications – "likely to be significant public interest". Enabling such discretionary notification will tighten the requirements for higher risk non-GMO field tests – in recognition of the range of possible non-GMO field-test applications, although not to the extent already required for GMO field-tests.
This option is consistent with the recent recommendation of the Primary Production Committee.
- It is proposed that ERMA be given both the discretion to publicly notify those hazardous substance applications under section 28 that do not otherwise qualify for rapid assessment and the ability to delegate the applications that are not publicly notified (or rapidly assessed) to its Chief Executive. The discretion to publicly notify will be exercised on the same basis as existing provisions for certain new organism applications in s53(2), i.e., whether ERMA considers there is likely to be significant public interest.
- These proposals will simplify and improve the efficiency of the assessment process for appropriate applications to import or manufacture hazardous substances.
- It is proposed that test certifiers have the discretion to issue a location test certificate on a
"provisional" (or conditional) basis where they consider the non-compliance with the relevant HSNO requirements to be due to minor or technical issues. The provisional certificate would state the outstanding matters, the time within which they would need to be rectified, and the manner of evidence required to demonstrate rectification. A normal location test certificate would then be issued once the test certifier is satisfied that the matters are no longer outstanding. This proposal will allow operations to continue lawfully while action is taken to ensure full compliance.
- It is proposed that the purposes for which an approved person may search the register be extended to include emergency and response planning purposes. The Fire Service would be able to search the register for that purpose, under delegation from an approved person (in accordance with s82B), as would all HSNO enforcement agencies, including those local authorities that have enforcement roles as per s97. These provisions will enable relevant parties to fully utilise the test certificate register as an efficient means of minimising potential threats to public health and safety in a more timely and effective manner.
- It is proposed to enable joint consideration of common changes to Part V hazardous substance approvals and group standard approvals established under Part 6A, including the option of adapting the group standard amendment process to the Part V reassessment process, as appropriate to the extent of the change, and to provide an equivalent to s67A for minor or technical changes to group standards. These proposals will remove the need for separate reassessment and group standard processes and reduce the consequent cost, potential for inconsistencies, and the potential confusion for industry.
- It is proposed to amend s97A of the HSNO Act to enable the enforcement agency responsible for the enforcement of the new organisms provisions of the HSNO Act (MAF) to use the cost recovery provisions of the Biosecurity Act, including the cost options (s135), levies (s137) and regulations (s165(1)(s)) to recover costs of performing HSNO functions in regard to new organism releases. The existing Biosecurity (Costs) Regulations 2006, with any necessary amendments, could then be used for cost recovery. This will be consistent with existing recovery of costs for performing HSNO functions in regard to new organism containment approvals. This cost recovery model is more appropriate to the development of an efficient monitoring system for the holders of the approvals for various releases of new organisms, as the costs are more readily identified.
- It is proposed to remove the two additional reporting requirements in section 147(3) and 148(b). This proposal will improve the cost and administrative efficiency of the statement of intent and annual report processes by reducing duplication, without adversely impacting on their quality, and enable more efficient use of resources for other regulatory activities.
- It is proposed to:
a. Extend ERMA's power to revoke test certificates to all test certificates; and
b. Extend the grounds for revocation under the HSNO Act to include where the criteria for which the certificate was issued are no longer met.
- It is proposed:
a. for offences involving hazardous substances, to change the current time to lay charges from 120 working days to 6 months (from when the offence became known), and allow the District Court to extend the 6 month period, consistent with the HSE Act, and
b. for offences involving new organisms, to change the time to lay charges to 2 years from when "the matter of the information arose", consistent with the Biosecurity Act.
These measures will help integrate the use of the enforcement provisions of these Acts, leading to the HSNO enforcement provisions being fully used.
Consultation
All the HSNO amendment proposals were developed in consultation with ERMA New Zealand and the respective agencies.
- This proposal is based on the practical experience of ERMA and informal comment by industry.
- The Primary Production Select Committee, in the report on its investigation into plant imports, recommended allowing the Authority "to delegate its power to conduct rapid assessments relating to the importation into containment of low risk [here non-GM (genetically modified) new plant] organisms". This was based on submissions to the Committee by a range of stakeholders in the plant import industry.
- To the extent that low-risk criteria are stated in regulation, consultation on the criteria for low risk non-GMO imports, developments and field-tests would occur during the development of those low-risk regulations.
- This proposal is based on the practical experience of ERMA and informal comment by industry.
- This proposal is in response to concerns raised by both test certifiers and businesses.
- This proposal is based on the practical experience of ERMA and concerns expressed by industry as to the relationship between Part V approvals and group standards.
- This proposal was initiated by concerns expressed by the New Zealand Fire Services and some regional councils.
- The purpose of this proposal is simply to empower the use of the Biosecurity Act cost-recovery tools. This proposal is consistent with a Cabinet direction to MAF to report on how HSNO-related costs might be recovered (POL Min (04) 24/10 refers). Consultation over specific proposals for cost-recovery would be undertaken as those proposals are developed.
- This proposal is based on the practical experience of ERMA.
- This proposal is based on the practical experience of ERMA.
- This proposal is supported by the Department of Labour and the Ministry of Agriculture and Forestry.
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