Environmental Law Initiative v Environmental Protection Authority
[2025] NZHC 3106
•17 October 2025
IN THE HIGH COURT OF NEW ZEALAND WELLINGTON REGISTRY
I TE KŌTI MATUA O AOTEAROA TE WHANGANUI-A-TARA ROHE
CIV-2024-485-612
[2025] NZHC 3106
UNDER the Judicial Review Procedure Act 2016 IN THE MATTER OF
an application for judicial review of a decision of the Environmental Protection Authority under s 62 of the Hazardous Substances and New Organisms Act 1996
BETWEEN
ENVIRONMENTAL LAW INITIATIVE
Applicant
AND
ENVIRONMENTAL PROTECTION AUTHORITY
Respondent
Hearing: 16&17 June 2025 Counsel:
R J B Fowler KC and T Upperton for Applicant N Whittington and C Jamieson for Respondent
Judgment:
17 October 2025
JUDGMENT OF GRAU J
TABLE OF CONTENTS
What this decision is (and is not) about [1]
Summary of result [8]
The statutory framework [13]
The history of regulation of glyphosate and GCS in Aotearoa New Zealand [26]
Developments leading to ELI’s request to the EPA to decide if there were grounds to reassess glyphosate and GCS [30]
The EPA's decision [37]
ENVIRONMENTAL LAW INITIATIVE v ENVIRONMENTAL PROTECTION AUTHORITY [2025] NZHC
3106 [17 October 2025]
Grounds of review [44]
Ground 1: application of the wrong legal test [46] The nature of the s 62 process to determine grounds for reassessment [49] The use of reliability standards [54]
A related issue—data gaps in real-world information [61]
“Weight of evidence” approach [64]
Ground 2: failure to take into account the purposes and principles
of HSNO [69]
Discussion [71]
Ground 3: failure to request further information [79]
Discussion [81]
Ground 4: failure to make a determination in respect of GCSs [85]
Discussion [87]
Ground 5: inconsistent application of legal tests [92]
Discussion [94]
Result [100]
What this decision is (and is not) about
[1] The Environmental Law Initiative (ELI) seeks a judicial review of Te Mana Rauhī Taiao | the Environmental Protection Agency (EPA)’s decision in July 2024 that there were no grounds for it to conduct a reassessment of glyphosate and a scheduled list of glyphosate-containing substances (GCS).1
[2] Glyphosate is a chemical used in herbicides, most notably “Roundup”, a weedkiller that is likely familiar to many New Zealand gardeners. Glyphosate is a hazardous substance that is regulated in New Zealand under the Hazardous Substances and New Organisms Act 1996 (HSNO).2
1 Environmental Protection Agency Decision: request to decide whether there are grounds for the reassessment of glyphosate and glyphosate-containing substances (5 July 2024, APP204718) [the decision].
2 Section 3 of the HSNO defines a hazardous substance as a substance with one or more of the intrinsic properties of explosiveness, flammability, a capacity to oxidise, corrosiveness, toxicity (including chronic toxicity) or ecotoxicity, with or without bioaccumulation. Hazard
[3] In October 2023, ELI requested the EPA—pursuant to s 62(1) of HSNO—to decide whether there were grounds to reassess glyphosate and GCS. ELI’s request was made on the basis that there was significant new information about the effects of these substances that points to risks to human health and to the environment. In particular, ELI considered there was significant new information about adverse effects on the environment, that glyphosate was a probable human carcinogen, as well as GCSs being more toxic than glyphosate itself. On 5 July 2024, the EPA decided that that the information ELI had provided in support of its request could not be considered as significant new information. It therefore found there were no grounds for reassessment under s 62(2)(a) of HSNO.
[4] ELI says the EPA’s decision has a number of flaws. ELI says the EPA has erred in applying the wrong legal test, failing to take into account the purpose and principles of HSNO, and failing to request further information from ELI. ELI also claims the EPA erred in failing to determine whether there were grounds for a reassessment of GCSs (in addition to glyphosate), and in taking an approach that was inconsistent with the approach it has taken in other requests for reassessment.
[5] ELI asks the Court to make a declaration that the decision was legally flawed and invalid. It asks the Court to quash the decision and order the EPA to reconsider the request for reassessment in accordance with the Court’s directions.
[6] The EPA accepts that, if it made an error, the Court should quash the decision and order a reconsideration. However, the EPA says its decision was correct and ELI’s judicial review application is based on a misunderstanding of the nature of the EPA’s power to decide if there are grounds to reassess a hazardous substance under s 62.
[7] This judicial review is not about whether glyphosate and GCSs remain safe to continue to be used in New Zealand or pose a risk to human health and/or the environment. It is only concerned with whether the decision of the EPA was lawfully
classifications for HSNO approved glyphosate active ingredients set out in the decision (at Table
1) refer to eye irritation, oral toxicity, and hazards to the aquatic environment, soil organisms and terrestrial vertebrates.
made in accordance with the legislation that governs the procedure it must follow to decide if grounds exist for it to reassess a hazardous substance.
Summary of result
[8] I do not consider that ELI has established a reviewable error in the EPA’s decision. The EPA did not take into account considerations that went beyond the test set out in s 62; rather it had regard to relevant matters in what is a highly discretionary exercise that serves a gatekeeping function. Those matters included the reliability of the studies and literature reviews provided by ELI—assessed through reference to reliability standards known as “Klimisch scores”—as well as a comparative weighting of ELI’s material against other recent reviews by international regulators.
[9] Nor did the EPA fail to take into account the purposes and principles set out in pt 2 of HSNO, given they were referred to in the EPA’s decision, many were not engaged, and a comprehensive consideration was not required.
[10] While the EPA had the ability to request further information from ELI, it was not required to do so.
[11] Although there was sparse express mention of GCSs in the body of the EPA’s decision, the summary of the information appended to the decision and the repeated references to GCSs in the supporting assessment report, including to studies and literature reviews, make it clear that they were considered.
[12] A review of other EPA grounds for reassessment decisions indicates the EPA has not applied s 62 inconsistently. A lack of reliability assessments in other decisions appears to be explicable when reliability concerns did not arise in those cases.
The statutory framework
[13] The HSNO provides for the management of hazardous substances and new organisms. Its purpose is to protect the environment and the health and safety of
people and communities by preventing or managing the adverse effects of hazardous substances and new organisms.3
[14]Sections 5–8 provide further guidance to achieve this purpose:
5Principles relevant to purpose of Act
All persons exercising functions, powers, and duties under this Act shall, to achieve the purpose of this Act, recognise and provide for the following principles:
(a)the safeguarding of the life-supporting capacity of air, water, soil and ecosystems:
(b)the maintenance and enhancement of the capacity of people and communities to provide for their own economic, social, and cultural well-being and for the reasonably foreseeable needs of future generations.
6Matters relevant to purpose of Act
All persons exercising functions, powers, and duties under this Act shall, to achieve the purpose of this Act, take into account the following matters:
(a)the sustainability of all native and valued introduced flora and fauna:
(b)the intrinsic value of ecosystems:
(c)public health:
(d)the relationship of Maori and their culture and traditions with their ancestral lands, water, sites, waahi tapu, valued flora and fauna, and other taonga:
(e)the economic and related benefits and costs of using a particular hazardous substance or new organism:
(f)New Zealand’s international obligations.
7Precautionary approach
All persons exercising functions, powers, and duties under this Act including, but not limited to, functions, powers, and duties under sections 28A, 29, 32, 38, 45 and 48, shall take into account the need for caution in managing adverse effects where there is scientific and technical uncertainty about those effects.
8Treaty of Waitangi
3 HSNO, s 4.
All persons exercising powers and functions under this Act shall take into account the principles of the Treaty of Waitangi (Te Tiriti o Waitangi).
[15] The precautionary approach, also called the precautionary principle, is a well- known concept within international environmental law. Article 15 of the 1992 Rio Declaration describes it as “[w]here there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost- effective measures to prevent environmental degradation”.4 Similarly, the preamble to the 1992 Convention of Biological Diversity provides that “[…] where there is a threat of significant reduction or loss of biological diversity, lack of full scientific certainty should not be used as a reason for postponing measures to avoid or minimise such a threat”.5
[16] Section 9 of HSNO provides for the establishment of a methodology for making decisions under pt 5 of HSNO, which governs assessments of hazardous substances and new organisms. It requires the EPA to “consistently apply that methodology when making such decisions”. The methodology is set out in the schedule to the Hazardous Substances and New Organisms (Methodology) Order 1998 (the Methodology Order). Clauses 29–31 of the schedule relevantly provide as follows:
29Where the Authority encounters scientific and technical uncertainty relating to the potential adverse effects of a substance or organism, or where there is disputed scientific or technical information, the Authority—
(a)must determine the materiality and significance to the application of the uncertainty or dispute taking into account the extent of agreement on the scope and meaning of the scientific evidence; and
(b)may, where the uncertainty or dispute is material or significant, facilitate discussion between the parties concerned to clarify the uncertainty or dispute.
30Where any scientific or technical uncertainty or dispute is not resolved to the Authority’s satisfaction during its consideration of the application, the Authority must take into account the need for caution
4 United Nations Rio Declaration on Environmental and Development UN Doc A/CONF. 151/26 (1992), art 15.
5 United Nations Convention on Biological Diversity 1760 UNTS 69 (opened for signature 5 June 1992, entered into force 29 December 1993), preamble.
in managing the adverse effects of the substance or (to the extent provided for under the Act) the organism concerned.
31Where the Authority considers that uncertainty arises from an absence of information, or inconclusive or contradictory information, or information from an unreliable source, the Authority may request the applicant to provide further information in accordance with section 58 of the Act and must take full account of any additional information provided.
[17] Part 5 of HSNO governs the assessment of hazardous substances and new organisms. Importation or manufacture of hazardous substances are both prohibited without an approval issued by the EPA under HSNO.6 A number of subparts set out the types of applications that may be made for EPA approval, including to:
(a)import or manufacture a hazardous substance;7
(b)import or manufacture hazardous substances in containment;8 and
(c)import or manufacture any hazardous substance for release in an emergency.9
[18] Procedures for the assessment of applications are set out in ss 52–67B. Sections 52–61 include matters such as:
(a)requiring an applicant to supply further information;
(b)public notification of applications;
(c)submissions on applications;
(d)enabling the EPA to commission a report, seek advice or obtain existing relevant information on the substance that is the subject of the application;
6 HSNO, s 25.
7 Section 28.
8 Section 30.
9 Section 47.
(e)time limits and waivers; and
(f)holding hearings of applications.
[19] After considering an application for approval of a hazardous substance, the EPA may, in its discretion, approve or decline the application if the positive effects of the substance outweigh the adverse effects.10 The EPA may decline an application if those adverse effects outweigh the positive effects, or if it has insufficient available information to determine adverse effects.11
[20] Approvals of hazardous substances made under HSNO do not expire. The only way an approval may be amended or revoked is through the reassessment process in ss 62, 63 and 63A.
[21] Section 62(1) enables any person to request the EPA to decide whether there are grounds to reassess any hazardous substance that it has previously assessed. Following a request made under s 62(1), the EPA may decide that grounds exist to reassess the substance, after taking into account:12
(a)that significant new information relating to the effects of the substance has become available; or
(b)any change in controls under the Health and Safety at Work Act 2015; or
(c)that another substance with similar or improved beneficial effects and reduced adverse effects has become available; or
(d)that new information showing a significant change of use, or a significant change in the quantity manufactured, imported, or developed, has become available; or
10 Section 29(1)(a), after taking into account any controls which may be imposed on the substance, all effects of the substance during its life cycle and the likely effects of the substance being unavailable.
11 Section 29(1)(b)–(c).
12 Section 62(2).
(e)whether the substance has been included in the reassessment work plan required by s 20C.13
[22] If the EPA decides there are grounds for a reassessment, s 63(1) provides that any person (including the EPA itself, via its Chief Executive) may request the EPA to proceed with a reassessment. Section 63(2) further states that a reassessment under s 63 “shall be deemed to be an application” and it sets out the various provisions under pt 5 of the Act that consequently apply. Section 63A then provides for a modified reassessment procedure for amendments to approvals of hazardous substances in certain circumstances which are not relevant here. A reassessment under s 63A is likewise deemed to be an application and the pt 5 provisions relevant to applications also apply.
[23] The only other decision that has considered the reassessment provisions of HSNO is Bleakley v Environmental Risk Management Authority.14 Bleakley was a judicial review about the failure of the EPA’s predecessor, the Environmental Risk Management Agency (ERMA), to reassess a field trial which involved genetically modified or transgenic sheep. The High Court described the process for reassessment as a “two-step one”, stating:15
If the Authority decides there are grounds to reassess an approval under s 62, s 63 provides that any person or the Chief Executive of ERMA may request the Authority to proceed with a reassessment. The reassessment is carried out under sections 39–45, with all necessary modifications, as if it were an application for approval of a new organism in containment.
[24] The High Court noted that the evidence of ERMA made it apparent ERMA was aware at all material times of the relevant risks in field trial (namely of horizontal gene transfer) and that the ERMA experts did not accept there was evidence of a material risk in that case.16 Miller J determined it was not for the Court to assess whether
13 Section 20C requires development of a work plan that sets priorities for reassessments of hazardous substances that are requested by the Chief Executive of the EPA. The work plan identities substances meriting reassessment that pose the highest risk (with priority ratings of A or
B) and prioritises those substances for reassessment. Glyphosate currently has a priority rating of E.
14 Bleakley v Environmental Risk Management Authority (2004) 11 ELRNZ 289.
15 At [34].
16 At [47].
ERMA’s experts were right, and said it was enough that very well qualified experts did not consider there was new information that justified further monitoring.17
[25] The applicability of Bleakley to this matter is limited, given it concerned reassessment of a new organism in containment as opposed to a hazardous substance. However, I consider this decision makes it clear that the Court’s review of a s 62 grounds for reassessment decision is not directed at re-evaluating the available information, but rather at determining whether the correct process was followed in concluding whether or not there were grounds to reassess the approval of the substance or organism.
The history of regulation of glyphosate and GCS in Aotearoa New Zealand
[26] The GCS “Roundup” was provisionally registered in Aotearoa in 1972 and fully registered and classified as a poisonous substance in 1975. ELI says it has been unable to find any record of an assessment undertaken at the time, beyond a reference to the original data package being provided by an organisation, some of whose work had subsequently been found to have been fraudulently produced.18 ELI says the approvals appear to have been “subsequently grandfathered” through successive regulatory regimes, namely the Agricultural Chemicals Act 1959, Pesticides Act 1979, the Toxic Substances Act 1979, and HSNO.
[27] The EPA does not disagree with ELI’s description of the history of regulation of glyphosate in New Zealand, although it notes that it is no different to the regulatory history of approximately 7200 substances that have been transferred from previous legislative schemes to the HSNO regime. The EPA observes that transitional provisions in Parts 11–15 of HSNO enabled hazardous substances assessed and approved under previous legislation to be transferred to the HSNO regime, which occurred during the 2001–2006 transfer period in respect of glyphosate and GCSs that had been assessed and approved under previous regulatory schemes.
17 At [49].
18 This data package was also said to have been “redone”, then reviewed in New Zealand and overseas and found to be satisfactory.
[28] Under the Hazardous Substances (Chemicals) Transfer Notice 2006, glyphosate and two salt forms, glyphosate trimesium and glyphosate isopropylamine, were deemed to have been assessed and approved by the EPA’s predecessor, the Environmental Risk Management Authority (ERMA), under s 29 of HSNO. Additionally, under the Hazardous Substances (Pesticides) Transfer Notice 2004, 19 GCSs were deemed to have been assessed and approved by the ERMA under s 29 of HSNO. While other GCSs have been approved by the EPA or ERMA under HSNO, ELI says it appears that most were approved with reference to other GCSs, rather than undergoing a separate assessment. ELI says it has been unable to find evidence of the EPA or ERMA carrying out any comprehensive risk assessment for glyphosate or GCSs, or any record of a risk assessment for glyphosate since the introduction of Roundup into New Zealand in the 1970s.
[29] The EPA agrees that the transfer process was not a risk assessment under HSNO, but also points out that the transfer process included review of previous approvals in order that hazard classifications could be assigned, and appropriate controls confirmed, modified or applied, for regulation under the new HSNO regime. The EPA has also pointed to ss 160A and 160B of HSNO (although now repealed) as an illustration of the process the relevant authorities have undertaken to transfer substances from a previous regime to HSNO. Under s 160A the relevant authority could issue a notice of transfer relating to a substance, which would deem it to have been assessed and approved. EPA points out this was not a rubber-stamping exercise: before doing so the authority had to consider best international practices and standards for safe management, as well as do everything reasonably practicable to advise all persons who might be affected and give them an opportunity to make submissions.
Developments leading to ELI’s request to the EPA to decide if there were grounds to reassess glyphosate and GCS
[30] In 2015 the International Agency for Research on Cancer reclassified glyphosate as a probable human carcinogen. In response, the EPA commissioned a review of the evidence relating to glyphosate and carcinogenicity (the 2015 review).19
19 Dr Wayne Temple Review of the Evidence Relating to Glyphosate and Carcinogenicity
(Environmental Protection Authority, August 2016).
The 2015 review was not a reassessment under HSNO; its scope was limited to carcinogenicity. The EPA’s review concluded that glyphosate was unlikely to be carcinogenic to humans.20
[31] In 2018, the Associate Minister for the Environment asked the EPA to consider reassessing glyphosate. The request was made in response to the 2015 decision of Johnson v Monsanto in the United States where a jury found Monsanto liable for the plaintiff’s non-Hodgkin’s lymphoma.21 The EPA declined to reassess.
[32] In April 2021, the EPA issued a call for information on glyphosate (CFI) to obtain a clearer picture of how glyphosate was used in Aotearoa. ELI submitted a response to the CFI on 17 September 2021, which focussed on the general toxic effects of glyphosate on ecosystems, the deficiency of data on the effects of glyphosate in Aotearoa on native species/organisms, the role of co-formulants/adjuvants22 in the toxicity of GCSs, the need for information on glyphosate use in practice, the need for robust cost-benefit analysis of glyphosate, and the need for independent science.
[33] On 11 May 2022, the EPA published its summary report, which it said would, with other information, form part of the information that could be used to assess whether to seek grounds to reassess the use of glyphosate in New Zealand.23 The summary report noted the EPA’s position on glyphosate was that it is safe to use provided specified controls and precautions are followed, but the EPA also accepted there were some concerns in the community about the possible impacts on human health and the environment.24 The report also said the call for information was intended to provide the EPA with a better picture of how glyphosate was used in Aotearoa before the European Union regulators (who were then reviewing approval of glyphosate) released their findings, which were due in 2023.25
20 At 16.
21 Johnson v Monsanto Co. 52 Cal. App. 5th 434 (2020).
22 A co-formulant or adjuvant is a non-active ingredient added to a chemical to improve its performance.
23 Environmental Protection Authority Glyphosate in Aotearoa New Zealand: Summary report on the call for information (11 May 2022).
24 At 7.
25 At 8. The European review was completed later that year. On 28 November 2023, the approval of glyphosate was renewed for 10 years.
[34] On 17 February 2023, the EPA announced the release of a work plan for all EPA-initiated reassessments of hazardous substances over the next three years. Glyphosate and GCSs were not on the work plan.
[35] After making a number of OIA requests between October 2022 and September 2023, ELI decided to prepare and submit a request to the EPA under s 62 of HSNO for the EPA to decide if there were grounds for reassessing glyphosate and GCSs. The request was made on the basis that significant new information relating to the effects of the substances had become available. Appended to the request was a link to reviews and papers collated by ELI, alongside an explanation of their findings and significance. ELI reports the request was submitted on 15 September 2023, with the EPA said to have formally received it on 14 February 2024.
[36] On 5 July 2024, the EPA issued its decision, which found that grounds did not exist for a reassessment of glyphosate and GCSs. The decision was accompanied by an assessment report prepared by EPA staff.26
The EPA’s decision
[37] The EPA’s decision-making committee (the Committee) considered the information provided by ELI, as well as the evaluation of the request by the EPA staff.27 It noted EPA staff had confirmed that glyphosate had recently been extensively reviewed by several European agencies—namely the European Commission, European Food Safety Authority (EFSA) and European Chemicals Agency (ECHA).28 The Committee considered that the large quantity of recent and relevant data and information evaluated by these bodies supported a position that no changes to hazard classifications were required, and the risks associated with the use of glyphosate had not changed since the previous EPA assessment.29
26 Environmental Protection Agency EPA Assessment Report: Grounds for reassessment of glyphosate and glyphosate-containing substances (April 2024) [EPA assessment report].
27 The decision, above n 1, at [36].
28 See European Commission Combined draft renewal assessment report and proposal for harmonised classification and labelling (2021); European Chemicals Agency Committee for Risk Assessment Opinion: proposing harmonised classification and labelling at EU level of
glyphosate (ISO); N-(phosphonomethyl)glycine (2022); and Fernando Álvarez and others “Peer review of the pesticide risk assessment of the active substance glyphosate” (2023) 21(7) EFSA Journal 8164.
29 The decision, above n 1, at [38].
[38] The Committee observed that Europe, the United States, Australia, Canada and the United Kingdom were in agreement that the current hazard classifications remain appropriate, and that risks to human health and the environment associated with the use of glyphosate had not changed based on the new information.30 The Committee found that, given the resources available to European regulators and the size and scope of their reviews, it was unlikely that there was significant new information the EU had not already considered.31
[39] The Committee also evaluated the weight of evidence from the EU assessments against the information provided by ELI.32 It acknowledged the EPA staff advice that the weight of evidence supported the EPA’s stance that risks to human health and the environment associated with glyphosate use had not changed based on updated information. The Committee considered that the EFSA and ECHA conclusions addressed the concerns raised by ELI in the grounds for reassessment request, given the findings that glyphosate should not be classified as a carcinogen, mutagen, or an endocrine disruptor.33 The Committee also determined that the evidence suggested no concern to groundwater, surface water, soil or sediment, with low potential for bioaccumulation when glyphosate is used according to prescribed controls.34
[40] Given the recent international evaluations addressing the concerns raised in the information provided by ELI, the Committee considered the information ELI had provided was not significant under s 62(2)(a) of HSNO in relation to the risks of glyphosate to human health and the environment.35
[41] The Committee also noted the EPA’s staff position that literature reviews would not typically be used to justify changes to hazard classifications or controls of an approval. Given it was unlikely that the literature reviews would justify a change to an approval, the Committee agreed that the literature reviews presented by the applicant could not be considered significant under s 62(2)(a) of HSNO.36
30 At [39].
31 At [40].
32 At [41].
33 At [42].
34 At [43].
35 At [44].
36 At [46].
[42] The Committee was of the view that, when the new international information did not identify any new significant risks, the current prescribed and additional controls applied to glyphosate and GCSs in New Zealand remained sufficient to manage any risks to human health and the environment.37
[43] As a result, the Committee concluded the information provided by ELI could not be considered significant under s 62(2)(a) of HSNO, and therefore it did not consider there were grounds for a reassessment on the basis of significant new information in relation to the effects of the substance.38
Grounds of review
[44]ELI seeks judicial review of the EPA’s decision on the following grounds:
(a)the EPA applied the wrong legal test—namely a reliability assessment and “weight of evidence approach”—in determining the significance of the information provided by ELI against existing evidence considered by the EU regulators, rather than considering whether the information was significant new information relating to the effects of the substances;
(b)the EPA failed to take into account the purpose and principles of HSNO, when, in determining ELI’s request, it did not act in accordance with the purpose in s 4 of HSNO, recognise and provide for the principles in s 5, take into account the matters in s 6, take a precautionary approach in line with s 7, and take into account the principles of Te Tiriti o Waitangi outlined in s 8;
(c)When the EPA had concerns about the reliability of the information ELI provided, its failure to request further information from ELI was a procedural error;
37 At [47].
38 At [48]–[49].
(d)the EPA failed to make a determination on whether grounds existed for the reassessment of GCSs, as it only found no grounds existed for the reassessment of glyphosate; and
(e)the EPA erred by applying the tests for “significant information” and “new information” inconsistently with the way it had determined previous requests in other cases.
[45] The EPA’s position is that ELI has misunderstood the nature of the EPA’s power under s 62 of HSNO which is initiated by a request. The EPA emphasises that a request is not the same as an application, to which a reasonably detailed set of procedural provisions and processes apply. In contrast, requests have comparatively few procedural provisions and instead a broad discretion is provided to the EPA. The EPA submits that, properly understood, s 62 is a gatekeeping provision for hazardous substances to fit into the EPA’s reassessment programme.
Ground 1: application of the wrong legal test
[46] For ELI, Mr Fowler KC submitted that, in making its decision, the EPA took into account considerations that went beyond the test set out in s 62. Those considerations included references to reliability standards, the application of a weight of evidence approach and references to the need for information under s 62(2)(a) to justify changes to an approval in what he described as a conflation of ss 62 and 63 of HSNO.
[47] In contrast, Mr Whittington, for EPA, submitted that ELI misunderstands the correct construction of s 62 of HSNO. He says the provision does not impose any fixed standard, threshold or test that needs to be met. Instead, it provides a broad discretion to consider any relevant matter in deciding whether there are grounds to reassess a hazardous substance or new organism. The EPA must take into account at least one of the factors in s 62(2) to decide if there are grounds for a reassessment. But, even if it finds one of those factors is established, a decision that grounds exist to reassess does not automatically follow. It is therefore a highly discretionary power and it is reasonably administrative in nature. Mr Whittington submits the matters
considered by the EPA were relevant to determine whether the information ELI provided with its request amounted to “significant” information under s 62(2)(a).
[48] Mr Fowler did not disagree that ss 62 and 63 have different functions. While agreeing there are important differences between the two provisions, it is ELI’s case that the EPA has made an error in applying a more intensive or higher threshold under the s 62 request by applying what are properly s 63 considerations. ELI says the EPA has conflated the grounds for reassessment with the test for reassessment itself. ELI also points to the importance of the s 62 process when approvals have no expiry and the only way to effect any change is via a reassessment.
The nature of the s 62 process to determine grounds for reassessment
[49] I agree with the submissions for the EPA that s 62 provides the EPA with a broad discretion to decide whether grounds exist to embark on the process of reassessing a hazardous substance. The breadth of the discretion is evident in the wording of s 62(2), which provides that the EPA “may” decide grounds for reassessment exist after “taking into account” the factors listed in s 62(2)(a)–(e). As noted by Mr Whittington, those factors are disjunctively listed, indicating only one of the factors must be present to enable the EPA to decide that there are grounds to undertake a reassessment.
[50] The presence of one of those factors also does not of itself require a reassessment to be undertaken. If that was Parliament’s intention, the legislation would have required that the EPA “must” reassess after finding there was, for example, significant new information relating to the effects of the substance. In my view, the purposes and principles of HSNO, which include the precautionary principle, might weigh in favour of reassessment in such circumstances. Or they might not, for example, if the new information did not affect a priority rating that meant it was considered as low risk, or if the EPA wanted to wait for a reassessment that was expected from an international regulator. In addition, s 63(1) further contemplates a request to the EPA to proceed with a reassessment after a decision by the EPA that grounds for reassessment exist, reinforcing that even a finding of grounds for reassessment does not automatically lead to a reassessment.
[51] Also relevant is the express link between s 62 and the EPA’s work plan which must be maintained in accordance with ss 20C and 62. Section 20C requires the EPA to take into account the criteria in ss 62(a)–(d) when developing or updating the workplan, with reassessing hazardous substances being a significant ongoing aspect of the EPA’s work. Section 62(2)(e) also requires the EPA to take into account whether a substance is included in its work plan when deciding whether there are grounds for a reassessment. As noted in the evidence of Dr Presow,39 the workplan identifies the substances meriting reassessment that pose the highest risk, namely those with priority rating A or B on the Priority Chemical List. This ensures efficient management of the EPA’s resources. I note that glyphosate has a priority rating of E.
[52] It is also the case that the decision-making power under s 62 may be delegated to any person. In contrast, an expert committee is required for a s 63 reassessment.
[53] I agree those matters point to a gatekeeping function which is highly discretionary and reasonably administrative in nature.
The use of reliability standards
[54] ELI complains about the EPA’s use of “Klimisch scores” in its decision to assess whether the information ELI provided was reliable.
[55] As noted in the evidence of Dr Hall40 and Dr Presow, Klimisch scores were developed to evaluate the quality of toxicological and ecotoxicological studies, both guideline (studies that comply with the OECD testing guidelines) and non-guideline. A study that is fully documented and carried out in accordance with a methodology equivalent to a guideline study is considered as fully reliable, whereas a study that is not well documented, has low statistical power, or deviates significantly from the guideline without justification, would receive a lower rating and would be considered less suitable as a reference for classification or risk assessment. As Dr Presow has explained, non-guideline studies are of variable quality, are typically looking at a certain effect, often from a more experimental basis and often using smaller numbers
39 Dr Shaun Presow is employed by the EPA as the manager of the hazardous substances reassessments team within the hazardous substances and new organisms group.
40 Dr Matthew Hall is the Director, Research and Legal, for ELI.
of study animals or innovative methodology that is not validated. The Klimisch score was developed to give a measure for comparison to OECD guideline studies.
[56] In his affidavit, Dr Hall notes that the EPA’s risk assessment methodology for hazardous substances explains that Klimisch scores are used to “help with understanding how significant any data gaps are for classification and the assessment of a substance” but no reference is made to using Klimisch scores in grounds for reassessment decisions under s 62.41 Dr Hall also notes that Klimisch scores have been criticised for a “narrow focus and exclusion of independent science”, with the use of criteria such as the principles of Good Laboratory Practice (GLP) reflecting the structure and resourcing of industry-funded research.
[57] Dr Presow has accepted that Klimisch scores do tend to favour guideline studies, and that GLP studies reflect industry-funded research. However, he also considers that this is not a major cause for concern. He notes that GLP accreditation and auditing mitigate against the risk of industry influence, and using Klimisch scores is the standard approach for regulators globally. Dr Presow disagrees with Dr Hall’s view that Klimisch scores are not intended to apply to grounds for reassessment requests. Dr Presow considers that there is no implication or indication that they cannot be considered for the purposes of a grounds for reassessment request.
[58] I am unable to accept that the EPA erred in referring to reliability standards in the form of Klimisch scores when it determined that the information provided by ELI was not significant. Rather, I agree that the reliability of information must necessarily be relevant to whether it amounts to “significant” information for the purpose of determining whether there are grounds for a reassessment based on that information. A method of assessing reliability, as Klimisch scores provide, must be appropriate to assist in that determination.
[59] The fact that Klimisch scores are referred to in the EPA’s risk assessment methodology does not suggest either that the EPA has applied a standard that is too high. Rather, it would appear incongruous to accept information as significant without
41 Environmental Protection Authority Risk Assessment Methdology for Hazardous Substances
(December 2022) at 36.
consideration of its reliability. Notwithstanding concerns that Klimisch scores tend to favour guideline studies and industry funded research, when the scores are widely used internationally and controls are in place to mitigate industry influence, it cannot be considered as unreasonable for the EPA to have deployed them to assess reliability. Accordingly, I do not consider that the decision’s reference to reliability based on Klimisch scores reflects the application of an incorrect legal test.
[60] It is also the case that the EPA’s assessment was made in the context of recent international regulator consideration which had resulted in no change to management regimes. ELI was critical of the deference EPA paid to international regulators. But I consider it was appropriate to acknowledge and take into consideration the existing reviews that had been undertaken recently by regulators in other jurisdictions, particularly when those regulators have far greater resources at their disposal and adhere to largely the same processes and standards. The findings of such regulators provide important context as to whether the information provided by ELI was significant new information.
A related issue—data gaps in real-world information
[61] Additionally, I do not consider the EPA erred in its discussion of gaps or voids in real-world information. Mr Fowler submits that the EPA, while focussing heavily (and even excessively) on reliability, did not address the issue of gaps or voids. He contends that such gaps result in uncertainty. Accordingly, the precautionary approach applies, requiring the EPA to undertake a reassessment.
[62] As outlined in the decision and supporting assessment report, EPA staff had acknowledged that data gaps in real-world information do exist.42 However, they noted that real-world system studies are expensive, inconsistent, and they can suffer from information or detection bias. They also noted that, to get a better understanding of potential risks, laboratory microcosms or mesocosms (simulated environments) tend to be used.43 The EPA staff considered that, while there are always areas of uncertainty when assessing the risks and benefits of a chemical, the lack of real-world
42 The decision, above n 1, at [34]; and EPA assessment report, above n 26, at [92].
43 At [89]–[90].
data does not necessarily mean that information on the risks of the chemical is deficient.44 They concluded that the studies discussing the data gaps were not relevant to the request, observing that, as the data gaps did not correlate with evidence of adverse effect, they could not be considered as significant information.45
[63] While I accept that the EPA’s decision made only brief mention of the issue of gaps in real-world information, it is apparent from the above that the EPA did in fact address this issue. The Committee was advised by EPA staff that the studies provided by ELI that referred to data gaps in real-world information did not amount to significant new information. Although the Committee did not expressly address this point in the reasons for this decision, I consider it can clearly be inferred from the Committee’s finding—that is, that there was no new significant information—that the Committee accepted the EPA staff’s advice on this issue. In other words, when data gaps highlighted in the application did not correlate with evidence of adverse effect, that meant those data gaps were not considered as significant information in relation to the effects of the substance. It is also apparent, when read in context, that the data gaps could not overcome the weight of evidence (particularly from the European regulators’ recent assessment) that the EPA concluded had addressed the concerns raised in the request for reassessment. The weight of evidence approach by the Committee is also the subject of criticism and is discussed next.
“Weight of evidence” approach
[64] Mr Fowler submits that, while an assessment of significance should obviously require a threshold of credibility, it does not involve a comparative weighting of evidence, which is properly an approach to be undertaken at the reassessment stage under s 63, not at the grounds for reassessment stage under s 62.
[65] In contrast, Mr Whittington contends that the significance of any new information cannot be considered in a vacuum. As he puts it, a number of studies pointing one way that are the only relevant studies will have a different level of significance than they would if there is also an existing and established body of many
44 At [91].
45 At [92].
other studies pointing the other way. He also points out that Parliament has set the threshold at “significant,’ making it a deliberate policy choice not to want regular reassessments.
[66] The submission for ELI has some force, in that a “weight of evidence” approach might appear to accord more with a reassessment determination. However, the s 62 decision is a highly discretionary one, and Parliament has made a deliberate choice to require “significant” information. In my view, it cannot be considered as inappropriate for the decision-maker to consider a wide range of information, that is, information that goes beyond what was provided in the request. Put another way, the wide discretion afforded under s 62 would appear to permit the decision-maker to assess the significance of the new information against other new or existing information it was aware of. In this case, that other information was most obviously the recent consideration of the same issue by major international regulators, including the European Commission, EFSA and ECHA.
[67] I also accept the submission for the EPA that, as recognised in Bleakley, it is not for the Court to assess whether the EPA’s experts are correct.46 Rather, in judicial reviews of discretionary decisions, particularly of specialist and expert bodies like the EPA, weight is a matter for the decision-maker, not the Court.47
[68] Accordingly, I do not consider it was an error for the EPA to undertake a weight of evidence assessment as part of its determination of whether there were grounds for a reassessment of glyphosate and GCSs. The EPA was of the view that the recent international evaluations addressed the concerns raised in the application and I do not see any basis on which this Court can or should second-guess that conclusion.
Ground 2: failure to take into account the purposes and principles of HSNO
[69] Ms Upperton argued this ground of review. She submits the EPA did not discharge the burden of establishing it had complied sufficiently with the requirements
46 Bleakley, above n 14, at [49].
47 See New Zealand Fishing Industry Association Inc v Minister of Agriculture and Fisheries [1988] 1 NZLR 544 (CA) at 551; Auckland Acclimatisation Society Inc v Sutton Holdings Ltd [1985] 2 NZLR 94 (CA) at 102; Waitakere City Council v Estate Homes Ltd [2006] NZSC 112, [2007] 2 NZLR 149 at [66]; and Te Rangi v Jackson [2015] NZCA 490, [2015] NZAR 1946 at [28].
under ss 5–8 of HSNO, when it only stated it had taken these matters into account and did not provide any further details. She says the EPA’s view appears to be that a precautionary approach is not required in regard to glyphosate. She also says the EPA has provided no evidence that it took into account the principles of Te Tiriti o Waitangi and submits that HSNO does not provide for a differential approach in considering pt 2 obligations at the reassessment stage under s 63 as opposed to the grounds of reassessment stage under s 62. Ms Upperton relies on the decisions in Whakatane48 and Jackson49 to support the submission that a “bare assertion” that relevant matters were taken into account is insufficient to discharge a “statutory burden”.
[70] Mr Whittington submits it has long been recognised that if a decision-maker approaches the specific decision-making task in accordance with the statute, a separate reference to principles and purposes is not required. He points to parts of the decision that he argues demonstrate pt 2 matters were recognised and provided for and considers ELI’s reliance on Whakatane and Jackson to be misplaced. Mr Whittington also submits that the EPA did not undertake a differential approach, and that, given the relationship between ss 62 and 63, it makes sense for the consideration of pt 2 matters in a decision under s 62 to be less comprehensive.
Discussion
[71] The decision records that the Committee referred to the need to take into account all relevant matters in pt 2 of HSNO and noted that if the request had been approved and a subsequent assessment had taken place, the considerations in ss 6–8 would need to be taken into account.50 Does this passage mean, as ELI contends, that those considerations were ignored? Or, as Mr Whittington submits, does it mean those matters were taken into account, although in a less comprehensive way than they would under a s 63 assessment?
[72] I accept Mr Whittington’s submission that pt 2 of HSNO is modelled on pt 2 of the Resource Management Act 1991 (RMA) which was the subject of discussion in the King Salmon case. In King Salmon, the Supreme Court considered that the purpose
48 Whakatane District Council v Bay of Plenty Regional Council [2010] NZCA 346.
49 Jackson v Te Rangi [2014] NZHC 2918.
50 The decision, above n 1, at [56]-[57].
of the New Zealand Coastal Policy Statement (NZCPS) was to achieve the RMA’s purpose in relation to New Zealand’s coastal environment. Accordingly, by giving effect to the NZCPS, a regional council was necessarily acting in accordance with pt 2 of the RMA.51 A number of caveats to this general proposition were identified, including that that the principles of the Treaty of Waitangi will have procedural as well as substantive implications that decision-makers must keep in mind.52 I find myself unable to agree King Salmon establishes that so long as a decision-maker approaches the specific decision-making task in accordance with the statute, separate reference to pt 2 matters is not required. It more specifically provides that a policy statement designed to achieve a statute’s purpose can be relied on to ensure a decision-maker is acting in accordance with that statute’s purpose. Although it could be argued that the Methodology Order under HSNO is equivalent to the NZCPS at issue in the King Salmon case, as will be discussed below in relation to ground three, very little of the Methodology Order applies to a ground for reassessment decision under s 62. I consequently consider the relevant purposes and principles do need to be separately referred to.
[73] However, such separate reference was made in this case. Although the decision did not explicitly set out that those matters were taken into account, neither can they be said to have been ignored. And I accept the submission that, in the highly discretionary s 62 process, consideration of the pt 2 HSNO matters will necessarily be less comprehensive.
[74] I also accept Mr Whittington’s submission that there are identifiable parts of the decision that engage with the purposes and principles outlined in pt 2 of HSNO. The application of Klimisch scores to the studies provided by ELI was a necessary step towards determining whether there was scientific uncertainty, and therefore whether the precautionary principle was engaged. I agree that, given the studies were not found to be sufficiently reliable to amount to significant new information, express discussion of the need for a precautionary approach was not necessary. As already mentioned, there was also recognition of data gaps in real world information but, as
51 Environmental Defence Society Inc v The New Zealand King Salmon Company Ltd [2014] NZSC 38, [2014] 1 NZLR 593 at [85].
52 At [88].
the EPA’s assessment report sets out, data gaps may be considered as significant if they correlate with evidence of adverse effects, which the EPA found was not the case with those gaps identified by ELI.53 I also agree that the issue here appears to involve controversy, rather than uncertainty. When that is the case, and uncertainty would seem to trigger a requirement to adopt a precautionary approach—but it was not considered to be present—there was no need to engage in a discussion about the precautionary approach.
[75] I also do not consider that a discussion of the principles of Te Tiriti o Waitangi was required. I accept the point that the principles would need to be considered if there was evidence that glyphosate and/or GCSs had a particular impact on, for instance, taonga species. But there has been no information to indicate as such.
[76] I now turn to ELI’s reliance on Whakatane and Jackson. Whakatane concerned the Bay of Plenty Regional Council’s failure to provide evidence that it had considered community views in relocating its headquarters. The Court of Appeal noted that giving consideration to views and preferences of the community was not achieved by mere knowledge of such views and preferences.54 The Court acknowledged that where a decision-maker makes a discretionary judgment, the court will not interfere unless it is irrational or wrong in principle, but it also considered that Parliament had stipulated the consideration of community views and preferences, which was to be reviewed by the Court.55 Similarly in Jackson, the High Court determined that, in the absence of evidence that particular views were taken into account in making a Board appointment, a statutory requirement had not been complied with.56
[77] I do not consider these decisions to be comparable to the circumstances in this case. In those cases, there was no evidence at all that the required views were taken into account. Here, the decision contains an express acknowledgement of the pt 2 matters. Furthermore, those cases concerned a prescribed step in a specific process for making a decision, whereas—as already noted—this case concerns a highly discretionary gateway (or threshold) decision.
53 EPA assessment report, above n 26, at [92].
54 Whakatane, above n 48, at [72]–[73].
55 At [76]–[77].
56 Jackson, above n 49, at [98]–[99].
[78] I agree that, due to the relationship between ss 62 and 63, with s 63 being subject to much more stringent procedural controls via the Methodology Order and the applicable provisions listed in s 63(2), it is logical for the consideration of pt 2 matters in a grounds for reassessment decision under s 62 to be much less comprehensive than in a s 63 reassessment. Nor does the s 62 process contemplate what would necessarily be required to assess the ss 6–8 considerations in any comprehensive way. I consequently do not consider the EPA erred in its statement that “if this request had been approved and a subsequent reassessment was applied for, these matters would be considered comprehensively in the context of such an application”.
Ground 3: failure to request further information
[79] Mr Fowler submits that, despite the precautionary principle and the statutory and regulatory recognition of the ability to seek further information from an applicant, the EPA failed to request further information from ELI during its decision-making process. He says this is a procedural error and the EPA’s failure to seek more information was procedurally unfair. A reasonable expectation of such a request is said to be supported by cl 31 of the Methodology Order and the wording of the s 62 request form. Mr Fowler contends the EPA should have raised its concerns with ELI about the reliability of the information ELI provided.
[80] Mr Whittington submits that ss 52–58 of HSNO and cl 31 of the Methodology Order do not apply to a s 62 request, as it is not an “application”. He acknowledges that the EPA had the ability to request further information, but argues the EPA was not required to do so. When the EPA had no obligation to inform ELI that the EPA saw issues about the reliability of the information ELI provided, there is therefore no basis for any claim of a “reasonable expectation”, and there is no clear explanation as to how EPA doing so would advance the purpose of HSNO.
Discussion
[81] Sections 52–58 of HSNO do not apply to a request under s 62. That is made clear when a reassessment under s 63 is deemed to be an application, with all the relevant provisions governing applications under HSNO applying with all necessary
modifications.57 If Parliament had intended such provisions to also cover requests under s 62, it would be expected to have provided as such. However, as acknowledged by Mr Whittington in his submissions, the broad discretion available to the EPA under s 62 means it can be inferred that the EPA may seek further information when determining a request under that provision. But the existence of that ability does not mean the EPA is obliged to use it.
[82] In respect of cl 31 of the Methodology Order, I note that the order was made under s 9 of HSNO. Section 9 provides that the Governor-General may establish a methodology “for making decisions under pt 5; and the Authority shall consistently apply that methodology when making such decisions”. Although a decision under s 62 of HSNO is a decision under pt 5, I accept the EPA’s reasoning that not all of the clauses in the Methodology Order apply to s 62, namely those that state they apply to “applications” or “applicants”, or those that refer to particular provisions that concern applications, such as s 58. Although it has already been set out above, I repeat the wording of cl 31 here for ease of reference:
31Where the Authority considers that uncertainty arises from an absence of information, or inconclusive or contradictory information, or information from an unreliable source, the Authority may request the applicant to provide further information in accordance with section 58 of the Act and must take full account of any additional information provided.
[83] The reference in cl 31 to s 58 of HSNO clearly indicates that cl 31 applies to applications for assessment and reassessments, rather than s 62 requests. Regardless, even if cl 31 did apply, its wording makes it clear that, even where the EPA considers uncertainty arises from insufficient or unreliable information, the EPA is not required to request further information. Instead it “may” make such a request.
[84] I do not consider that the EPA erred in failing to request further information. I agree that doing so would not have advanced the purpose of HSNO, when the EPA was not uncertain about the information the request relied on and it did not consider there was a need to seek clarification. There is no requirement under HSNO that the EPA needs to inform a s 62 requester that the information provided to support the
57 HSNO, s 63(2).
request is considered unreliable. There is also no evidence to support a finding of a reasonable or legitimate expectation of further information being requested. When there was a large existing body of information, including relatively recent information, that the existing controls for glyphosate and GCSs were sufficient to mitigate risks, it does not appear to be procedurally unfair for the EPA not to request more information after finding the supporting information did not amount to “significant” information under s 62(2)(a).
Ground 4: failure to make a determination in respect of GCSs
[85] Mr Fowler says that all of the EPA’s considerations in its decision were directed to glyphosate, with no separate consideration of GCSs which were the other substances that were included in ELI’s request. He observes that the assessment report acknowledges that co-formulants affect the hazardous properties of a substance, but submits that it again conflates the grounds for reassessment stage with the reassessment itself. He notes the evidence of Dr Byrom58 that both glyphosate and GCSs were considered and argues there is a clear line of authority that it is unacceptable for a decision-maker to augment the record of their decision with further explanation or supplementation.
[86] Mr Whittington submits that, notwithstanding the submission of ELI that GCSs are only referred to in a single paragraph of the decision, GCSs are referred to throughout, including the summary, background, and various paragraphs of the decision. He says it is also reasonable to infer that some of the references to glyphosate are intended to stand as a shorthand for the whole scope of the request, which included glyphosate and GCSs. In response to ELI’s claims about the evidence of Dr Byrom, Mr Whittington said she did not augment the record of the decision, but rather pointed to the content of the decision as making clear that GCSs were considered, with no further information given beyond what was already in the decision.
58 Dr Andrea Byrom was the chair of the EPA’s decision-making committee in this case.
Discussion
[87] I accept that GCSs are not widely discussed in the EPA’s decision. The only explicit references in the Committee’s decision are at [47] and [58] where it says:
[47] The committee considered that given that the new international information does not identify any new significant risks, the current prescribed and additional controls (i.e. modified prescribed controls specific to an approval) applied to glyphosate and glyphosate-containing substances in New Zealand remain sufficient to manage any risks to human health and the environment.
…
[58] The committee concluded that the information provided by the applicant, combined with the weight of the evidence available, did not indicate a change in risk to human health or the environment, nor did it justify changes to the hazard classifications or controls of glyphosate or glyphosate- containing substances.
[88] However, in making its determination, the Committee considered the EPA’s assessment report. That report contained a number of references to GCSs, including:
(a)a finding that, since it was unlikely there is significant information the EU did not consider in its recent reviews of glyphosate, it was appropriate to assume that the risks from glyphosate and GCSs had not significantly changed and therefore no changes were required to the New Zealand approval of glyphosate;59
(b)that the EPA considered the current prescribed and additional controls applied to glyphosate and glyphosate-containing products mitigate any potential risks to human health and the environment;60
(c)an express mention that ELI had raised the issue of co-formulants in GCSs, and a finding that, if the request under s 62 is granted, the scope of a reassessment may not allow for the co-formulants to be assessed in the same level of detail, as the formulation data for each approval containing glyphosate and a co-formulant would need to be supplied by
59 EPA assessment report, above n 26, at [73].
60 At [76].
the importer or manufacturer to assess the hazardous properties of each mixture;61 and
(d)a finding that, after reviewing the information received in the CFI and the information provided by ELI, the EPA did not consider the risk to be sufficient to require a reassessment of glyphosate and GCSs.62
[89] Similar references can be found in parts of the decision outside of the Committee’s consideration, as noted in the EPA’s submissions. In particular I note that in Appendix B to the decision, titled “Summary of information provided by the applicant”, there is a reference to a literature review in which the author stated that commercial formulations were 77 times more lethal than glyphosate in isolation.63 Reference is also made to a study where formulations were assessed as being 3 to 358 times more toxic than glyphosate alone,64 as well as another literature review where glyphosate formulations were found to be more toxic than glyphosate alone.65 It is apparent from the EPA’s decision that these studies were considered by the EPA. All were the subject of an assessment of “where the weight of evidence lies in comparison with the data presented by the application”. In all cases, the EPA was satisfied that the weight of evidence lay elsewhere.
[90] I also accept Mr Whittington’s submission that it can be reasonably inferred that some references to “glyphosate” in the decision include both glyphosate and GCSs. Such an inference can readily be made when, as outlined above, appended to both the reassessment report and the decision was a list of the various GCSs, and the weight of evidence exercise already mentioned in respect of studies ELI provided in support of its argument that co-formulants in GCSs increased their toxicity. I also observe here that, near the beginning of the decision where the Committee describes the request as being for a reassessment of glyphosate and GCS, it goes on to refer to
61 At [94]–[95].
62 At [116].
63 Betsabé Lares and others “Effects of glyphosate on cladocera: A synthetic review” (2022) 249 Aquatic Toxicology 106232.
64 N Defarge, J Spiroux de Vendômois and G E Séralini “Toxicity of formulants and heavy metals in glyphosate-based herbicides and other pesticides” (2018) 5 Toxicology Reports 156.
65 R Mesnage and others “Potential toxic effects of glyphosate and its commercial formulations below regulatory limits” (2015) 84 Food and Chemical Toxicology 133.
the seeking of grounds to reassess “the substance”. That term, which I consider clearly relates to both glyphosate and GCSs, is repeated.66
[91] I do not agree with Mr Fowler either that Dr Byrom’s affidavit amounts to an augmentation of the record of the decision. Rather, Dr Byrom stated it was clear from the decision that both glyphosate and GCSs were considered. She did not offer explanations or evidence that GCSs were considered beyond what was already recorded in the decision. This is evident from her statement that:
As far as I am concerned, Dr Fletcher and I considered whether there were grounds to reassess both glyphosate and GCSs. Our decision makes this clear.
Ground 5: inconsistent application of legal tests
[92] ELI also considers that the EPA has not taken a consistent approach to its reassessment decisions. In particular ELI says the EPA has interpreted “significant new information” differently in other grounds for reassessment decisions. Mr Fowler has referred to EPA decisions concerning Minecto Star, Fluazinam, and Tebuconazole and Propiconazole, in which new information from international regulators was held to be “significant”. Although ELI does not dispute that information from international regulators may well be significant, it says that the EPA’s inconsistent application of rigorous reliability requirements at the grounds for reassessment stage in this case is procedurally unfair when consistency of treatment is an important principle of public administration.67
[93] Mr Whittington argues that none of the comparator decisions concerned new information from guideline or non-guideline studies, therefore there was no occasion to consider Klimisch scores in taking into account whether the new information was significant in those other cases.
Discussion
[94]It is helpful to discuss the comparator decisions briefly:
66 The decision, above n 1, at [13]–[14] and [20]. See also [26] and [49].
67 With reference to Ririnui v Landcorp Farming Ltd [2016] 1 NZLR 1056 at [93].
(a)The Minecto Star decision concerned a request for reassessment by a producer in light of new information about the aerial application of an insecticide.68 It related to the proposed use of a different application method. The information was considered significant as it provided evidence of increased benefits associated with aerial application. The EPA also noted that other products with the same active ingredients were already applied aerially.
(b)The Tebuconazole and Propiconazole decision concerned a request by the EPA for reassessment of fungicides used in timber treatments.69 The new information in that case came from regulatory reports prepared by the EFSA and European Chemicals Agency Risk Assessment Committee (ECHA RAC). The information was considered significant as it contained information about the toxicological and ecotoxicological effects of the substances.
(c)The Fluazinam decision concerned a request by the EPA for reassessment of a fungicide used to control diseases in various fruit and vegetable crops.70 The information provided included recent overseas regulators’ reports. It was found to be significant as it indicated that additional controls may be necessary to mitigate risks to human health and the environment.
(d)The chlorpyrifos and chlorpyrifos-methyl decision concerned a request by the EPA for reassessment of pesticides.71 The information provided included regulatory decisions of Australian, European and American regulators, as well as two studies that identified the presence of chlorpyrifos in New Zealand streams, air and soil following
68 Environmental Protection Authority Decision: request to decide whether there are grounds for reassessment of Minecto Star (3 March 2022, APP204405).
69 Environmental Protection Authority Decision: request to decide whether there are grounds for reassessment of Tebuconazole and Propiconazole (8 March 2021, APP204030).
70 Environmental Protection Authority Decision: request to decide whether there are grounds for the reassessment of fluazinam (7 December 2021, APP204188).
71 Environmental Protection Authority Decision: application to decide whether there are grounds for the reassessment of chlorpyrifos and chlorpyrifos-methyl (15 September 2020, APP204032).
application. The two studies had not been reviewed in detail by the EPA, and so the Committee did not consider them significant. The Committee also found, however, that they supported the evaluation of any future reassessment. In contrast, the other information was considered significant as it provided justification for revising the hazard classification, risk assessment and controls on the substances.
[95] It is apparent that, other than the chlorpyrifos decision, none of these comparator decisions concerned guideline or non-guideline studies as the decision in this case did. Rather, they concerned information either provided directly from the producer of a hazardous substance, or from overseas regulators. In terms of the information provided by the producer in the Minecto Star decision, it was also supported by the fact that other products with the same ingredients had already been approved for aerial application.
[96] I do not agree with Mr Fowler that there has been inconsistent application of reliability requirements, which has meant the determination of the grounds for reassessment of glyphosate and GCSs was procedurally unfair. As noted above, Klimisch scores were developed for the assessment of guideline and non-guideline studies. Since the Minecto Star, Fluazinam, and Tebuconazole and Propiconazole decisions did not concern such studies, there was no reason or need to apply Klimisch scores.
[97] Klimisch scores also did not need to be applied in the chlorpyrifos decision. While they perhaps might have been applied to the two studies referred to in the decision, it was the decisions of overseas regulators that were considered decisive as significant new information establishing grounds for a reassessment. Although the reliability of the studies was not expressly considered, in my view it can be reasonably inferred from the chlorpyrifos decision that the fact the studies were not considered significant was at least partly due to potential reliability concerns.
[98] Beyond concerns around Klimisch scores, a lack of discussion of reliability generally in those decisions appears to be explained by the fact that, since the information came from recognised overseas regulators who had inevitably conducted
their own assessment, reliability concerns did not arise. Consequently, it was not necessary to consider the issue.
[99] I also do not accept that a preliminary reliability assessment at the grounds for reassessment stage is procedurally unfair because non-industry external requesters will not have the same access to new information. Although industry requesters will have greater resources, and thus a greater ability to obtain high quality information to support a request, I concur with Mr Whittington that it is not for the EPA to level the playing field. Regardless of who the requester is, where studies are being relied upon to seek a reassessment, such as in this case, it is appropriate for the EPA to examine the reliability of the studies to determine whether they do provide grounds to reassess a hazardous substance.
Result
[100] None of the grounds advanced by ELI have persuaded me that the EPA’s decision was unlawful. Accordingly, the application must be dismissed.
[101] I ask the parties to endeavour to reach agreement on costs. If that is not possible, memoranda may be filed (no more than five pages) within 15 working days after receipt of the decision and I will determine costs on the papers.
Grau J
cc: R J B Fowler for Applicant
N Whittington for Respondent
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