DECISION
www.epa.govt.nz
5 July 2016
1. Summary
Substance Poncho Votivo
Application code APP202077
Application type To import or manufacture for release any hazardous substance under
Section 28 of the Hazardous Substances and New Organisms Act
1996 (“the Act”)
Applicant Bayer New Zealand Limited
Purpose of the application To import Poncho Votivo, containing 502 g/L clothianidin and 102 g/L
Bacillus firmus, into New Zealand for use as a seed treatment in
maize and corn
Date application received 1 October 2014
Hearing date 3 December 2015 - 26 May 2016
Consideration date 26 May 2016
Considered by Dr Kevin Thompson – Chair
Dr Louise Malone
Dr John Taylor
Dr Ngaire Phillips
Decision Approved with controls
Approval code HSR101149
Hazard classifications 6.1D, 6.5A, 6.5B, 6.9B (oral), 9.1A, 9.2B, 9.3C, 9.4A
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Table of Contents
1. Summary .................................................................................................................................. 1
Table of Contents .................................................................................................................................. 2
2. Executive summary ..................................................................................................................... 3
3. Identification and intended use ................................................................................................. 4
4. Application process .................................................................................................................... 5
5. The Evaluation and Review Report (EPA Staff Report) and additional information ............ 6
6. The Hearing and Consideration Process .................................................................................. 7
Hearing ............................................................................................................................................................. 7
7. Consideration ............................................................................................................................ 14
Hazard classifications ..................................................................................................................................... 14 Identification of controls .................................................................................................................................. 14 EPA risk assessment of Poncho Votivo .......................................................................................................... 15
Risks during manufacture, packaging and importation 15 Risks during transport and storage 15 Risks during use 15 Risks during disposal 18 Relationship of Māori to the environment 18 Assessment of risks to society, the community and the market economy 18
Variations to the default controls ..................................................................................................................... 19 Additional controls ........................................................................................................................................... 19 Review of additional controls and variations ................................................................................................... 20 Assessment of benefits ................................................................................................................................... 21 Other relevant matters to be taken into account.............................................................................................. 21
8. Conclusion ................................................................................................................................ 22
9. Decision ................................................................................................................................ 23
Appendix A: Controls applying to Poncho Votivo ........................................................................... 24
Additional controls 29
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2. Executive summary
2.1. Poncho Votivo is a seed treatment intended to be used for the prevention of insect and nematode
damage in cereal, maize, sweetcorn, forage brassica and grass seed.
2.2. The application to import Poncho Votivo was made by Bayer New Zealand Limited and was publically
notified in accordance with section 53 of the Act.
2.3. During the submission period, nineteen submissions were received on the application; from Michael
Tott, Jon Carapiet, Marcia Lawerence, Mike McCree, Joanne Churcher, Ross Scholes (NZ Peasants
Association), John Phillips, Elaine Bainbridge, Patricia Wallace, Jenny Kirk, Te Rūnanga o Ngāi Tahu,
Sarah Russell, Celeste Hayward-Ryan, Sidney Lovell, Claire Bleakley, Kate Hughes, Federated
Farmers of New Zealand Bee Industry Group, the National Beekeepers Association of New Zealand,
and David Chisholm. Of these submitters, Te Rūnanga o Ngāi Tahu (Ngāi Tahu), the National
Beekeepers Association, and the Federated Farmers Bee Industry Group did not indicate their
opposition to the application. All other submitters opposed the application.
2.4. The National Beekeepers Association, Claire Bleakley and Sarah Russell requested to speak at a
hearing and on 3 December 2015 a hearing was held in Wellington. The applicant presented at the
hearing in support of the approval of the application and verbal submissions were heard from Don
MacLeod of the National Beekeepers Association, Claire Bleakley and Sarah Russell.
2.5. In addition the Committee was advised by Dr Newstrom-Lloyd, a specialist in honey bee and hive
health in New Zealand, who was appointed as an advisor to the Committee.
2.6. After considering all relevant information available at the time of the hearing, the Committee decided
that it did not have sufficient information with which to make a decision on this application. The
Committee adjourned the hearing in order to evaluate new information from submitters, the applicant,
members of the Committee, and Dr Newstrom-Lloyd.
2.7. The Committee reconvened at the offices of the EPA in Wellington on 26 May 2016 and decided there
was sufficient information with which to make a decision. The Committee closed the hearing and
started its consideration of the application.
2.8. With the suite of controls presented in Appendix A of this document, the Committee assessed the risks
posed by Poncho Votivo and determined that they would be negligible. The Committee assessed the
level of benefits associated with Poncho Votivo and determined that they would be non-negligible. In
accordance with Clause 26 of the Methodology, the Committee decided to approve the application to
import Poncho Votivo.
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3. Identification and intended use
3.1. Poncho Votivo is intended for use as a seed treatment to prevent insect and nematode damage in
cereal, maize, sweetcorn, forage brassica and grass seeds. It contains 508 g/L of clothianidin and 102
g/L of Bacillus firmus I-1582.
3.2. Bacillus firmus is not a new organism in New Zealand, but is not presently a component of a pesticide.
3.3. Clothianidin, a neonicotinoid, has been previously approved for use as a pesticide ingredient in New
Zealand, in similar or higher concentrations than in Poncho Votivo. For example, the applicant has a
currently approved product on the market in New Zealand as a seed treatment, Poncho, which
contains 600 g/L clothianidin.
3.4. The applicant intends to import Poncho Votivo into New Zealand fully formulated, packed and labelled,
and sold only to professional seed treatment companies who have the appropriate skills and
equipment to apply it.
3.5. It is intended that the substance should be used completely via seed treatment, but the applicant notes
that any waste product can be disposed of in a waste treatment facility approved for this type of waste.
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4. Application process
Formal receipt and notification
4.1. The application was formally received by the EPA on 1 October 2014.
4.2. The Minister for the Environment was advised of the application in writing on 15 October 2014, in
accordance with section 53(4) of the Act. The Ministry for the Environment, WorkSafe New Zealand,
the Ministry of Health, the Department of Conservation and the Agricultural Compounds and
Veterinary Medicines (ACVM) group of the Ministry for Primary Industries were advised of the
application and notified of the submission period. No comments or submissions on the application
were received from these parties.
4.3. The application was publicly notified and opened for submissions on 15 October 2014. The
submission period closed on 27 November 2014.
Additional information requests from the EPA and additional information provided to
potential submitters
4.4. During the evaluation of the application and submissions, the EPA staff requested additional
information from the applicant under sections 52 and 58 of the Act. That information was summarised
and made available to all submitters and the applicant via the EPA Staff Report on 20 November
2015. As the hearing was not convened within the statutary timeframe under section 58(2), a waiver
was given under section 59(4).
Submissions received
4.5. Nineteen submissions were received in response to public notification of the application. All
submissions expressed concern about the potential impact of clothianidin on bees. Submitters
generally noted:
The importance of bees to agriculture, horticulture, export crops and human food chains
Residue of clothianidin in soils
The effect of dust from seed treatment
Transmission of clothianidin into pollen and nectar via the vascular system of the plant
Neonicotinoids can have sub-lethal effects on bees that reduce hive success
That some neonicotinoids have been associated with hive collapse in Europe and a moratorium
has been placed on their use pending further information.
4.6. The Committee noted that the EPA Staff Report responded to these issues and the Committee
considered the EPA risk assessment on the effect on bees when making this decision.
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5. The Evaluation and Review Report (EPA Staff Report) and additional information
5.1. The Staff Report is the staff’s review of the application and available data regarding the substance and
provides information to assist the Committee’s decision-making. The staff conducted quantitative
human health and environmental risk assessments. These assessments considered the exposure and
subsequent effects on people and the environment throughout the life cycle of the substance.
5.2. Confidential information was provided by the applicant, which was taken into account in the staff
assessment of Poncho Votivo. The confidential information included the following:
the formulation of Poncho Votivo
toxicological and ecotoxicological studies on the product, the active ingredient and its metabolites
chemical and physical properties of the product information on the active ingredient
a draft label.
5.3. Based on all the available information, the staff assessed the potential risks the substance may pose
to the environment, human health, the relationship of Māori to the environment, society, community,
and to the market economy.
5.4. The staff identified a suite of default controls based on the hazard classifications of Poncho Votivo.
They also considered variations to these controls, and the addition of extra controls, in accordance
with section 77 and section 77A of the Act.
5.5. The Staff Report concluded that with the default controls, the proposed variations to these controls,
and the addition of extra controls, the risk to human health and the environment would be managed.
The staff recommended to the Committee that with the proposed controls in place, the overall level of
benefit provided by the availability of Poncho Votivo would outweigh the overall risk.
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6. The Hearing and Consideration Process
Hearing
6.1. On 3 December, a hearing was held at the Willeston Conference Centre in Wellington. Presentations
were given by the applicant, the EPA staff and submitters.
Applicant’s presentation
6.2. The Poncho Votivo application was represented by Tonde Kaitano, Pete Fisher, and Dr Christian
Maus, all from Bayer, in support of the application.
6.3. Mr Kaitano began by outlining the Bayer mission which is to use science to improve the quality of life
for humans and other animals.
6.4. Poncho, a Bayer product containing 600 g/L clothianidin, has been approved for use in New Zealand
since 2003. Mr Kaitano presented evidence that B. firmus brings significant benefits to crop growing.
Bacillus firmus is found naturally in New Zealand and is globally ubiquitous. Bayer added it to a
product already available on the market (Poncho) and created Poncho Votivo. He clarified that the
application is focused on seed treatments for maize and sweet corn only.
6.5. Mr Kaitano noted that both components are already in New Zealand, but said Bayer welcomes the
opportunity to communicate with submitters and address some of the “misinformation that is out there
regarding Bayer products”.
6.6. Mr Kaitano also discussed the benefits derived from Poncho Votivo; namely that it controls critical
pests like Argentine stem weevil, black beetle, greasy cutworm, and parasitic nematodes. Clothianidin
has a systemic action so only pests that attack the crop are affected. Bayer considers this mode of
action more effective than insecticides that remain on the surfaces of plants only. This systemic
property also allows for application of the product as a seed dressing, which can offer advantages over
foliar or drench applications of insecticides.
6.7. Bayer outlined a number of pests farmers face, to highlight the benefits from using Poncho Votivo.
They noted that Argentine stem weevil kills the plant, inflicts sub-lethal damage and reduces crop yield
at rates greater than 30%. Argentine stem weevil is impossible to control with non-systemic
insecticides, so without them farmers have to leave fields fallow for up to 6 weeks. For greasy cut
worm, foliar insecticides can be effective but require multiple applications. Foliar insecticides are
imprecise in their application and their lack of effectiveness against pests can incur yield losses of
greater than 20%. For black beetle the only other alternative insecticide is an organophosphate
(phorate) that is highly hazardous and performs poorly. Farmers can experience yield loss greater
than 10% if black beetle is not controlled.
6.8. Mr Kaitano explained that maize is an important livestock and dairy feed and it reduces the need to
import palm kernels for fodder. Clothianidin is applied at hugely reduced rates compared with other
control options (phorate or chlorpyrifos for example).
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6.9. He discussed why Bayer had chosen to add B. firmus to Poncho and explained that the bacterium
colonises the root surface and forms a biofilm there. The bacterium uses sugar exudates from the
roots and thereby masks the presence of the root to nematodes. Furthermore, B. firmus produces
indolacetic acid, a phytohormone which stimulates plants growth, and it also sometimes solubilises
nutrients in the soil, resulting in increased root mass. This in turn increases yields from agricultural
land.
6.10. He noted that when used in accordance with the manufacturer’s instructions “Poncho Votivo has a
high level of safety”.
6.11. Mr Kaitano noted the submitters concerns regarding bees and observed that bees are thriving in New
Zealand despite the use of clothianidin in the country since 2003. He noted that honey bees cannot
survive in New Zealand without human intervention because of the varroa mite. He also noted that
bees are thriving in Australia despite long term use of neonicotinoids.
6.12. Dr Christian Maus presented examples of higher tier studies which Bayer used to evaluate the effects
of clothianidin on bees. In summary he suggested that these studies showed no adverse effects on
bees under what was considered realistic in-field exposure conditions.
6.13. Dr Maus also discussed exposure to clothianidin via dust. He explained that the product is applied as
a seed coating, which ensures that it is retained on the seed. Seed treatment quality must be good to
ensure all the product sticks to the seed and goes into the soil where it cannot affect non-target insects
like bees. There have been examples of poor coating where dust has rubbed off during planting, but
this is a well-known exposure route that can be managed and there are no recorded incidents in New
Zealand via this exposure route.
6.14. Dr Maus also described the restrictions in place on neonicotinoids in the European Union (EU). He
explained that while the EU had concerns about the effects of neonicotinoids (including clothianidin)
on bees, the EU had not banned any products but had placed a moratorium on their use until
additional information could be gathered. He considered that relevant field studies had not been taken
into account in the EU risk assessments and that improved stewardship over the past five years was
not considered.
6.15. Dr Maus presented on other risk areas:
Mammalian toxicity; Poncho Votivo has low levels of toxicity
Dust-off risk is negligible due to the film coating and a fluency agent which is applied to the seeds
in the planting hopper (~9 g of polymer wax which coats the seeds as they are sown)
Ring-testing systems are being set up for bumblebees and solitary bees, in addition to the usual
tests with honey bees.
Field studies show risk via pollen exposure is negligible
6.16. He finished Bayer’s presentation by agreeing with the EPA Staff Report that the risks from Poncho
Votivo are negligible.
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6.17. The Committee asked Dr Maus to clarify why pollen is not an exposure pathway and he responded
that after a systemic seed treatment, very small amounts of clothianidin are found in the blossom and
nectar so only traces are found in pollen. The quantities are much smaller than the level that has been
identified to be safe for bee colonies.
6.18. The Committee also asked about nematodes and the B. firmus component of Poncho Votivo,
particularly the extent of a nematode problem in New Zealand compared with other countries. Bayer
only had data from the US, and did not have a specific dataset from New Zealand. As the study they
presented provided evidence of the growth promoting benefits for B. firmus to the plant, they chose not
to further promote the prevention of nematode attack as a benefit.
6.19. The Committee questioned whether Poncho would still be imported into New Zealand or whether it
would be removed from the market. The applicant responded that Bayer’s commercial intent is to
remove Poncho as an option for use on maize and to specify use of Poncho Votivo on maize and
sweet corn instead, but that Poncho will not be removed entirely from the market. EPA staff added that
they would not expect there to be any change in the mode of action between maize and sweet corn.
6.20. The Committee also questioned the environmental fate of clothianidin on seeds that do not germinate.
The applicant responded that it is broken down in the soil via microbial action. There is 0.75 mg of
active ingredient per kernel and the half-life is strongly dependent on the soil type and the climate.
Data from Europe suggests a range of 20 – 200 days half-life in the soil if the active ingredient is not
taken up by the plant.
6.21. Claire Bleakley asked whether the staff had considered the synergistic effects of the product in its
combined form, particularly in regards to bee toxicity. EPA staff confirmed that there are no known
synergistic effects in any part of the plant tissue. Ms Bleakley considered that the staff failed to assess
the toxicity of the full formulation of Poncho Votivo and how they work synergistically, such that
Section 28(2) of the Act has not been met.
6.22. The Committee, in its consideration, reviewed the evidence to determine whether there were any
possible synergistic effects between active ingredients. The Committee found no evidence that
clothianidin is acting synergistically in a way that is relevant to bee toxicity in particular or to the staff
risk assessment.
6.23. Don MacLeod asked for clarification that B. firmus has been trialled in New Zealand. The applicant
responded that it has been approved for residue and efficacy trials by the Ministry for Primary
Industries (MPI) and Bayer will continue to monitor its efficacy as it wants to confirm that its investment
is sound. Mr MacLeod then asked whether that monitoring is to include New Zealand vertebrate and
invertebrate off-target effects, to which the applicant responded that it is uneconomic for Bayer to do
country specific monitoring on off-target organisms.
6.24. Mr MacLeod asked about bacteria on the plant roots and whether there is clothianidin residue in the
sugars associated with the root mass. The applicant responded that the gradient is such that
clothianidin moves into the root from the treatment as the plant grows, but it is not associated with
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sugar molecules outside the plant and the sugars should not have any of the active ingredient
associated with them.
6.25. Claire Bleakley asked whether all nematodes are detrimental to plants and the applicant replied that
not all nematodes are parasitic to plants, so the B. firmus component of Poncho Votivo only affects
nematodes which would otherwise be attracted to the plant.
Staff presentation
6.26. Dr Trudy Geoghegan represented the EPA staff and addressed the hearing, providing an overview of
the Staff Report and a detailed summary of the risk assessment. She outlined the scope of the hearing
and clarified that the Committee cannot ban, revoke or recall other approved substances, and that
those are processed via an EPA reassessment.
6.27. Dr Geoghegan explained that the risk assessment on B. firmus found it to be non-pathogenic, with no
toxicological effects, but that it can be an eye and skin sensitiser, so staff recommend that personal
protective equipment (PPE) be worn when interacting with it. She also highlighted the effects on native
and threatened birds. She explained that staff had used a very conservative risk model that assumed
birds only eat seeds and shoots of treated seeds. Controls to store seeds away from bird access and
to ensure all seeds are covered by soil at the time of planting have been proposed.
6.28. Finally Dr Geoghegan recommended the application be approved with controls, including a suite of
variations to the standard controls triggered by the hazard classifications.
6.29. The Committee asked whether there were any studies on the impact of pollen from treated maize
plants on bee hives. EPA staff answered that field studies on the effects of pollen from plants treated
with Poncho Votivo on hives were used in the staff risk assessment.
6.30. The Committee considered whether there is any evidence of maternal transfer of the product among
birds from the mother to the egg. EPA staff clarified that there are no studies on this, and that in
addition, there is no evidence of bioaccumulation of clothianidin in fish, although there are no such
data available for bird flesh, eggs or feathers.
6.31. The Committee considered the impact on Māori culture, when birds like pukeko can get into maize
fields and eat the seeds and pull the shoots from the ground. Julian Jackson responded on behalf of
the EPA staff that the control proposed by the EPA is the best in the circumstances and is appropriate
to mitigate risks to Māori culture.
6.32. The Committee considered whether bees have been shown to use maize or corn for foraging, and Dr
Geoghegan responded that while these are not typically attractive to bees, they do appear to forage
for pollen in these crops.
6.33. Mr MacLeod asked EPA staff to confirm that the concentration of clothianidin on seed would be about
the same for both Poncho and Poncho Votivo. EPA staff responded that their evaluation and review
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was based on the most recent information on the amounts applied to seed and that they have
proposed controls using the application rates provided by the applicant.
Presentations provided by submitters
6.34. Don MacLeod presented on behalf of the National Beekeepers Association of New Zealand
(NBKANZ). He stated that the “number one biosecurity risk to New Zealand is the introduction of new
organisms that may adversely affect them (bees)”. He expressed concern that there is no information
on the import and quarantine of B. firmus being imported from overseas.
6.35. The Committee noted that any biosecurity risk from B. firmus is regulated under the Biosecurity Act.
6.36. Mr MacLeod said that the Beekeepers Association is critical of the control that sets the concentration
of the treatment at 120 ml / 80,000 maize seeds, as it is not appropriate to manage the risks. He said
that the association does not agree with the reasoning in the Staff Report not to provide an
environmental exposure limit for soils.
6.37. Mr MacLeod presented information on some test results he had obtained showing the presence of
clothianidin in soil samples taken from New Zealand maize fields The Committee asked Mr MacLeod
to explain why he thought bees could be exposed to clothianidin via soil. Mr MacLeod suggested that
the day after harvest, bee keepers anecdotally report that bees feed on the sap exuding from cut
maize and corn stems and are found dead in the fields. He explained that this phenomenon is known
as maize flats die-off, and that he is gathering support for future research into the area, which would
test dead bees for clothianidin residue and also confirm soil and/or sap from cut stems as exposure
routes for clothianidin into the bees.
6.38. The Committee asked Mr MacLeod whether there was a correlation between the distance of hives
from the maize fields and the number of hives that die, or whether hive die-off has been reported in
regions not associated with maize crops, and Mr MacLeod reported that there are no data available to
address either of those questions. Mr MacLeod also reported that currently, maize growers tell
beekeepers when they are about to harvest and the beekeepers move their hives.
6.39. Sarah Russell spoke to her submission and said that “innovation should follow the precautionary
principal [sic]”. She did not consider that the applicant had demonstrated the need for nematode
control, and she expressed concern that the product kills the non-target nematodes, which are
beneficial to the soil. Mr Kaitano confirmed the B. firmus occurs on the surface of the root and does
not spread into the soil. The nematode eggs have to be in direct contact with the root to be affected.
He clarified that the bacteria will not be moving through the soil and finding nematodes to kill.
6.40. Ms Russell noted that although B. firmus is not a new organism in New Zealand, it is to be imported in
Poncho Votivo from a wild strain in Israel. She questioned whether there are “controls in place to
ensure that this bacterium won’t unbalance native populations of B. firmus and other soil bacteria and
invertebrates”. She also noted that Poncho Votivo seems to have a negative effect on waterways and
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the marine environment. EPA staff noted that due to the method of application, via seed treatment,
they did not consider there was risk to waterways and the marine environment.
6.41. Ms Russell noted the effects of neonicotinoids on bees via pollen, nectar and water exudates, and she
questioned the accumulative effect of insecticides. In addition, she expressed surprise that no tests
have been done in New Zealand. She considered that the way forward should be a complete overhaul
of the risk assessment process and a better understanding of the effects of neonicotinoids on
invertebrates, and of B. firmus of nematodes.
6.42. Claire Bleakley spoke to her submission and noted that there are “so many data gaps that along with
the precautionary approach, and according to the unknown effects I ask you to decline this
application”.
6.43. She stated that there is no information presented on our native pollinators. She also stated that
Poncho Votivo has significant non-target effects via exudates and these have not been taken into
account. She considered that native species vital to biodiversity have not been assessed by EPA staff:
for example, 3 genera and 29 species of native bees, all of which nest in clusters in holes in the
ground and could be affected by clothianidin in the soil.
6.44. The Committee considered the PhD thesis Ms Bleakley presented about native bee foraging,
specifically around a study on regenerating forest habitats and whether the thesis specifically refers to
native bees foraging on maize. Ms Bleakley clarified that the thesis does not specify whether native
bees utilise maize and corn ecosystems.
6.45. Mr Kaitano explained that species testing is done using representative surrogate species to test for
ecotoxicological effects. Greater numbers of taxa are represented by these studies and the physiology
of similar species is the same regardless of which country they come from. With regards to ground
nesting native bees, although this could be considered a different exposure route, “we would not
expect ground nesting bees to have nests in arable fields due to field use, harrowing, irrigation, etc...”.
6.46. The Committee considered whether using surrogates is an adequate representation and whether the
mode of action of Poncho Votivo is the same on comparable taxa. The Committee determined that this
was an appropriate use of surrogacy.
Applicant’s right of reply
6.47. Mr Kaitano stated that in terms of benefits, “we have data from the US. The benefits far outweigh any
risks”.
6.48. Mr Kaitano stated that Poncho Votivo is precisely targeted, and based on current knowledge there is
not an insecticide that works better in terms of target effect, lack of collateral damage and increases to
yields. This represents a “paradigm shift towards using safer chemistry”. He finished by asking the
Committee to approve the application.
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6.49. The Committee decided to allow the late submission of material from submitters who originally notified
that they wished to be heard. This information included:
Neonicotinoid pesticides severely affect honey bee queens. Williams et al (2015)
One additional academic review of the effects of clothianidin not sponsored by Bayer
The applicant provided new information on its stewardship manual
Don MacLeod submitted his confidential study on maize flat disease
Claire Bleakley submitted the PhD thesis and an additional reference
A letter of support from the Foundation for Arable Research (FAR)
Sarah Russell provided a list of websites with relevant information she had used in her submission.
6.50. The Committee asked Dr Newstrom-Lloyd to review the new information and prepare a summary
report for its consideration, including a review of the available literature on the effects of neonicotinoids
on honey bees. This review was provided to the Committee and submitters on 12 April 2016, and
assessed by the EPA staff.
6.51. On 21 April 2016, the EPA staff released a supplementary annex to their original Staff Report, in which
they outlined how they had considered the new information provided to the Committee, reiterated the
risk assessment methodology used in their assessment, and stated that the new information did not
change the results of their initial risk assessment. They recommended to the Committee that the
application be approved with the controls provided in the original Staff Report.
6.52. The Committee noted that the supplementary information had been valuable and informative, and they
wish to thank the people who took time to make submissions on the application and who spoke at the
hearing.
6.53. On 26 May 2016, the Committee was satisfied they had sufficient information with which to make a
decision. The hearing was closed and they commenced their consideration of the application.
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7. Consideration
7.1. The following information was considered by the Committee:
The application
The submissions
The EPA Staff Report
Information presented at the hearing by the applicant, the submitter(s), and the EPA staff, and
Additional information provided at the hearing by submitters, the applicant, members of the
Committee and Dr Linda Newstrom-Lloyd, an expert in bee nutrition and bee health.
7.2. Further comments on different aspects of this information can be found in the sections following.
Hazard classifications
7.3. The Committee adopted the hazard classifications for Poncho Votivo as recommended by the staff,
based on the information provided by the applicant and on other available information as documented
in the Staff Report (Table 1). This information included study data, as well as mixture rules
calculations.
Table 1: Hazard classification of Poncho Votivo
Hazardous property Classification
Acute toxicity (oral) 6.1D
Respiratory sensitisation 6.5A
Contact sensitisation 6.5B
Target organ systemic toxicity 6.9B (oral)
Aquatic ecotoxicity 9.1A
Soil ecotoxicity 9.2B
Terrestrial vertebrate ecotoxicity 9.3C
Terrestrial invertebrate ecotoxicity 9.4A
Identification of controls
7.4. The suite of controls proposed by the staff, and considered by the Committee was detailed in full in
Appendix A of the Staff Report1. The control suite included:
Default controls i.e. those triggered by the aquatic ecotoxicity hazard classification of Poncho
Votivo
Deletions and variations to the default controls in accordance with sections 77 and 77A of the Act.
1 http://www.epa.govt.nz/search-databases/HSNO Application Register
Documents/APP202077_APP202077_EandR_FINAL_for_web.pdf
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Additional controls, proposed in accordance with section 77A of the Act.
EPA risk assessment of Poncho Votivo
7.5. The Committee took into account the staff’s risk assessment for Poncho Votivo as detailed in the Staff
Report. The key points are summarised below.
Risks during manufacture, packaging and importation
7.6. The Committee noted that the applicant intends to import Poncho Votivo packaged ready for sale. The
risks associated with both the import and manufacture of Poncho Votivo were considered by the
Committee based on the staff’s risk assessment.
7.7. The Committee considered that adherence to HSNO controls (such as labelling, emergency
management and secondary containment) would ensure that the level of risk to human health or the
environment during import or manufacture of Poncho Votivo would be negligible.
Risks during transport and storage
7.8. The Committee considered that people and the environment would only be exposed to the substance
during transport and storage in isolated incidents where a spill occurs. Once in New Zealand, HSNO
controls (e.g. labels, safety data sheets and packaging) and adherence to the Land Transport Rule
45001, Civil Aviation Act 1990 and Maritime Transport Act 1994 would apply.
7.9. Based on the staff advice the Committee considered that, given compliance with the HSNO controls
and other legislative requirements, the likelihood of a person being repeatedly exposed to the
substance was so low that the resulting level of risk to human health would be negligible.
7.10. The Committee considered that adherence to the HSNO controls (such as labelling, SDS, packaging
emergency management and secondary containment) during transportation and storage would ensure
that the level of risk to the environment from Poncho Votivo would be negligible.
Risks during use
Human health effects
7.11. The Committee noted that the staff’s quantitative human health risk assessment for clothianidin and
qualitative assessment for B. firmus, detailed in the Staff Report, determined that the risks to operators
would be acceptable as the proposed uses of Poncho Votivo resulted in risk quotients below the
acceptable operator exposure level (AOEL) when appropriate personal protective equipment (PPE)
and respiratory protective equipment (RPE) are worn.
7.12. The Committee also noted that the staff’s exposure modelling indicated that risks to operators and re-
entry workers were acceptable even without the use of PPE. Staff had recommended to the
Committee that it is considered good practice to use PPE when handling agrichemicals.
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Aquatic organism effects
7.13. The Committee considered that due to the method of application, i.e. as a seed coating, risks to the
aquatic environment from Poncho Votivo would be negligible.
7.14. The Committee considered that with the controls in place the level of risk to the aquatic environment
during use would be negligible.
Soil organism effects
7.15. The staff advised the Committee that the risk assessment showed no impact on earthworms and other
soil organisms as the active ingredients are not mobile in the soil. The Committee considered that the
risk to non-target soil organisms would be negligible.
Terrestrial vertebrates (birds) effects
7.16. The Committee considered, based on the staff advice, that there was a high risk to birds from eating
treated seeds and an acceptable risk to birds eating emergent shoots. The staff proposed controls to
manage these risks:
Excess treated seeds shall not be left in areas accessible to birds
Treated seeds shall be completely covered by soil when sown.
7.17. The Committee considered that the risk to birds from eating emergent shoots would be negligible
given the conservative parameters used in the staff risk assessment. The Committee considered that
with the controls in place, the risks to birds from eating treated seeds would be negligible.
Terrestrial invertebrates effects
7.18. The staff advised the Committee that Poncho Votivo represents a low toxicity to non-target arthropods.
The Committee considered that, with the default and additional controls in place, the risk to terrestrial
invertebrates from the use of Poncho Votivo would be negligible.
7.19. However, most of the submitters expressed concern about the effect of Poncho Votivo, and in
particular the active ingredient clothianidin, on bees.
7.20. The Committee considered that there is a gap in the available scientific evidence for a causal link
between clothianidin and hive deaths. However, while there is evidence that clothianidin can affect bee
populations in field settings, the Committee found it difficult to project the results into environmental
scenarios and conclude whether or not clothianidin is safe for bees, or safe for bees when controls are
applied appropriately. The Committee also considered that if there was evidence that clothianidin is
affecting bees, then products containing clothianidin as the active ingredient are already in use in New
Zealand, and declining Poncho Votivo would not change the overall risk profile in the environment.
However, the Committee noted that they would not approve a substance that could be known to cause
harm to the environment. Further, the Committee noted that the level of uncertainty around safety to
bees was not considered sufficient to warrant the EPA declining the application in these
circumstances.
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7.21. The Committee considered the review provided by Dr Newstrom-Lloyd. The Committee noted that
while the report does discuss sudden and dramatic collapse of hives, there is no long term information
and no correlation between clothianidin and any type of hive collapse.
7.22. The Committee considered the extent of the gap in knowledge around the level of clothianidin in maize
sap, and whether this is a genuine exposure route with a significant effect on bees. The Committee did
not consider the extent of the gap in knowledge significantly changed their assessment of the risks
associated with clothianidin. The Committee also noted that if it becomes aware of any new significant
information, the EPA has the authority to reassess all substances containing clothianidin in New
Zealand.
7.23. The Committee noted that their uncertainty was the potential risk to honey bees, and the knowledge
that the affected industry can and does currently manage any potential risk, mitigated this uncertainty.
The Committee noted that New Zealand does not have the rapid colony loss problems that are found
in bees overseas, so the urgency in New Zealand is different from the international experience.
7.24. Honey bees are a managed insect and not a wild or native bee. Honey bee numbers therefore depend
on the number of beekeepers and the profitability of beekeeping. The Committee considered that
clothianidin does not have a significant effect over and above other approved agrichemicals. While the
Committee noted that honey bees have value, they are not native to New Zealand and our food
supplies are not under threat from their decline. While the thesis on native bee ecology provided at the
hearing was valuable in considering the effects on native bees, the Committee was not aware of any
studies on maize and the relationship to native bees, and considered that any possible exposure
pathways would not have a significant negative population level effect.
7.25. The Committee noted the brevity of the EPA staff response to the evidence presented at the hearing,
but further noted that it also considered Dr Newstrom-Lloyd’s review, and the additional literature
provided by submitters and the applicant. The Committee agreed with the summary statement of
Godfray et al (2015) that “there still remain ...gaps in our understanding of how pollinator colony-level
(for social bees) and population processes may dampen or amplify sub-lethal effects of neonicotinoid
exposure and their effects on pollinator services; as well as how farmers might change their agronomic
practices in response to restrictions on neonicotinoid use and the resulting positive or negative effects
on pollinators or pollination”. The Committee considered that the papers included in Dr Newstrom-
Lloyd’s review do not provide a cast iron solution one way or another, and there is not enough
information to firmly establish that clothianidin has a detrimental effect on New Zealand bee
populations. The Committee noted the comment by Lundin et al (2015) that “Current research
momentum, and recent rapid increases in the number of studies being published on this topic, provide
opportunities to provide a more comprehensive understanding of how neonicotinoids are affecting
bees”.
7.26. The Committee considered that New Zealand is not facing a national emergency with regards to bee
health, but looks forward to seeing the results of new studies both here and overseas as they become
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available. If further studies somehow prove a link between treated maize crops and significant post-
harvest decline of bees, the Committee noted the EPA could conduct a reassessment of clothianidin.
Risks during disposal
7.27. The applicant had indicated that the preferred disposal method is to use the product completely (until
totally consumed) according to label directions.
7.28. The Committee noted that disposal of the substance and used containers in accordance with the
requirements of the Hazardous Substances (Disposal) Regulations 2001 would ensure individuals and
the environment were not exposed to the substance.
7.29. Accordingly the Committee considered that with controls in place the level of risk to human health and
the environment during disposal would be negligible.
Relationship of Māori to the environment
7.30. The Committee noted that the staff assessed the potential effects on the relationship of Māori to the
environment in accordance with sections 6(d) and 8 of the HSNO Act. This included an assessment of
the potential impacts of Poncho Votivo on kaitiakitanga and the Treaty of Waitangi.
7.31. In their submission and hearing presentation Ngāi Tahu noted that the amount of data made available
to the public was extremely limited and that they felt this made it impossible to evaluate the potential
for risk. They also considered that the approval of an application for a hazardous substance, where
uncertainty exists regarding the potential for adverse effects on taonga species and traditional Māori
values and practices, may be viewed as being inconsistent with the principle of active protection in the
Treaty of Waitangi.
7.32. While these frustrations are acknowledged, the Committee noted that given the risk assessment
provided in the Staff Report, the level of uncertainty relating to the potential for impact to taonga
species, Māori values and practices is unlikely to be significant.
7.33. Based on the Staff Report and other information provided to the Committee by the applicant and
submitters, the Committee considered that with the controls proposed in place the impact of the
substance on the relationship of Māori to the environment would be negligible. The Committee
considered that the application is unlikely to be inconsistent with the principles of the Treaty of
Waitangi.
Assessment of risks to society, the community and the market economy
7.34. The staff advised the Committee that they did not expect there to be any significant adverse impacts
on the social environment in the event of the approval and controlled use of Poncho Votivo, apart from
the possible environmental effects already discussed. Accordingly, the Committee considered the risks
to society, the community and the market economy would be negligible.
7.35. Therefore the Committee considered the overall level of risk to society, the community and the market
economy would be negligible assuming compliance with the proposed controls in place.
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Variations to the default controls
Exposure limits set for this substance
7.36. Acceptable Daily Exposure (ADE), Potential Daily Exposure (PDE) and Tolerable Exposure Limits
(TELs) can be set for Class 6 substances to control hazardous substances entering the environment in
quantities sufficient to present a risk to people. No ADEs have been set because exposure to this
substance via environmental media is not likely to result in an appreciable toxic effect. As no ADEs are
set, no PDE or TELs values have been set at this time.
7.37. The staff advised the Committee that the EPA typically adopts Workplace Exposure Standard (WES)
values generated by WorkSafe New Zealand to control exposure in places of work. The Committee
decided to apply these WES values in accordance with section 77A(3)(5) of the Act.
7.38. The default controls allow the setting of Environmental Exposure Limits (EELs) to control hazardous
substances entering the environment in quantities sufficient to present a risk to the environment. EELs
have not been set for any component of Poncho Votivo at this time as the level of risk to the
environment, with other controls in place, is considered to be negligible. The default EEL values have
therefore been deleted.
7.39. The default controls require the EPA to set a maximum application rate for a Class 9 substance for
which an EEL has been set. As no EEL has been set for Poncho Votivo, a maximum application rate is
not required to be set under regulation 48 of the Hazardous Substances (Classes 6, 8, and 9 Controls)
Regulations 2001. However, a maximum application rate has been set under section 77A of the Act,
based on the use pattern described by the applicant.
7.40. The staff advised the Committee that the default controls do not address the risks associated with
storage or use of the substances within stationary container systems (e.g. tanks). These risks include
the failure of primary containment resulting in a large spill of the substance into the environment. In
addition, the default controls do not allow for dispensation where it is unnecessary for any pipework
associated with the stationary container systems to have secondary containment. Accordingly,
controls addressing these risks are considered more effective than the default controls in terms of their
effect on the management, use and risks of the substance. The Committee agreed, and has set the
tank wagon controls requirements as an additional control.
7.41. Staff also advised the Committee that the emergency management requirements set out by the default
controls are more restrictive than necessary for substances which do not ignite or explode (such as
Poncho Votivo). The Committee agreed that these requirements could be reduced and has varied the
control.
Additional controls
7.42. The staff advised the Committee that the quantitative human health risk assessment showed
acceptable levels of risk to operators and bystanders. However, the staff recommended to the
Committee that a label statement requiring appropriate PPE would be in-line with good agrichemical
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practice. Accordingly, the Committee requires the following statement to be included on the substance
label:
A person who handles this substance or seeds treated with this substance, or who cleans
equipment used to handle, treat or sow seeds treated with this substance must use protective
clothing or equipment that is designed, constructed and operated to ensure that the person -
(a) does not come into contact with the substance; and
(b) is not exposed to a concentration of the substance that is greater than the workplace exposure
standard for the substance.
7.43. The Committee noted the staff’s advice that there may be risks if the substance is used beyond the
parameters that the applicant had proposed and the staff modelled. To ensure that no unforeseen
effects of the substance arise, the Committee decided that restrictions concerning the application rate,
minimum application interval, application method and application frequency should be applied.
Accordingly the Committee has applied additional controls under section 77A(3)(c) of the HSNO Act
addressing these restrictions. These controls are detailed in Appendix A.
7.44. The Committee noted that there was a risk to birds. The staff advised the Committee that a control
requiring that seeds be stored away from areas easily accessible to birds, and ensuring that treated
seeds be covered with soil during planting, would be effective control measures to reduce risks of
adverse effects. The Committee agreed with this assessment and applied controls under section 77A
of the HSNO Act. These controls are detailed in Appendix A.
7.45. Finally, the Committee considered that a series of label statements was the best way to make sure
users were aware of these additional restrictions.
Review of additional controls and variations
7.46. The Committee considered that each of the additional controls and variations to default controls
mentioned above are either:
a) more effective in terms of their effect on the management, use and risk of the substance; or
b) more cost-effective in terms of their effect on the management, use, and risks of the substance; or
c) more likely to achieve their purpose.
7.47. The full suite of controls, including variations, can be found in Appendix A.
7.48. At the hearing the applicant was given an opportunity to comment on the proposed controls as set out
in the Staff Report. The applicant did not indicate that they had any concerns with the controls at that
point, and the Committee has not made any significant changes to the controls that the staff proposed,
other than minor wording changes which do not alter the intent of those controls.
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Assessment of benefits
7.49. The applicant referred to several benefits of the substance in the application and elaborated on these
at the hearing. The staff also provided some information to support these claims. These benefits
included the following:
Poncho Votivo has fewer toxicological hazards and lower environmental hazard classifications than
other agrichemicals for the same purpose, and can therefore be considered a safer alternative to
those products
Poncho Votivo improves crop yield
Poncho Votivo will provide a benefit to growers and regional economic benefits to small
organisations.
7.50. The Committee considered that Poncho Votivo has the same benefits profile as Poncho, with
additional benefits derived from the inclusion of B. firmus as an active ingredient. After considering the
available information, the Committee considered that there are benefits that will be derived for New
Zealand by allowing the use of Poncho Votivo.
7.51. The Committee noted that as with other recent applications these benefits were not very well
articulated in the application. It was only after discussions at the hearing, that the benefit of Poncho
Votivo in improving crop yields became clear.
Other relevant matters to be taken into account
The effects of the substance being unavailable
7.52. The Committee considered that if Poncho Votivo was unavailable, the effects included fewer tools for
pest management and potentially higher toxicological risks associated with other pesticides currently
on the market. The Committee noted the first could result in an adverse impact on crop quality and
have flow-on economic impacts.
Relationship of Māori to the Environment
7.53. The potential for toxic effects to birds and the uncertainty of effect posed to those species valued by
Māori, was of particular relevance to the consideration of impact to the relationship of Māori to the
environment. The Committee has set additional controls to reduce the risks acceptable levels including
burial of seeds, and increased labelling requirements.
7.54. Given that assessment, and in the absence of any identification or discussion of further risk to the
relationship of Māori to the environment, the Committee was satisfied that the controls imposed enable
the use and management of Poncho Votivo to be consistent with the principle of active protection.
New Zealand’s international obligations
7.55. The staff advised the Committee that they did not identify any international obligations that may be
impacted by the approval of Poncho Votivo.
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8. Conclusion
8.1. Taking into account the assessment of the potential risks and benefits associated with Poncho Votivo,
and applying a precautionary approach, the Committee considered that, with all of the controls in
place:
The overall risks to human health and the environment arising from the hazardous properties
(ecotoxicity to the environment) and the use of Poncho Votivo would be negligible
Significant adverse impacts on the social or economic environment from the use of Poncho Votivo
are not anticipated
Significant impacts on Māori culture or traditional relationships with ancestral lands, water, sites,
wāhi tapu, valued flora and fauna or other taonga that will breach the principles of the Te Tiriti o
Waitangi/Treaty of Waitangi are not anticipated
Benefits will be derived for New Zealand by allowing the use of Poncho Votivo.
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9. Decision
9.1. Pursuant to section 29 of the Act, the Committee considered this application to import a hazardous
substance for release made under section 28 of the Act. In doing so, the Committee applied the
relevant sections of the Act and clauses of the Hazardous Substances and New Organisms
(Methodology) Order 1998 (“the Methodology”).
9.2. The Committee was satisfied with the hazard classifications identified in Table 1 and applied these
classifications to Poncho Votivo.
9.3. The Committee considered that, with controls in place, the overall risks associated with the release of
Poncho Votivo would be negligible. Except in the area of uncertainty noted above, the Committee
considered the risks are negligible given the current state of knowledge, and with the controls in place.
The Committee considered that it is important to note that there is a gap in the knowledge of the health
of the New Zealand honey bee population which cannot be extrapolated from overseas, and of the
effect of Poncho Votivo outside of agricultural limits. The Committee used the information available at
the time of the decision.
9.4. Taking into account the need for caution, and considering that the controls ensure environmental
protection, the Committee considered that the benefits associated with the release of Poncho Votivo
are non-negligible and are considered to outweigh the negligible risks presented by Poncho Votivo.
Therefore, the Committee approved the importation and manufacture of the hazardous substance
Poncho Votivo, in accordance with clause 26 with the controls as listed in Appendix A.
Dr Kevin Thompson Date: 5 July 2016
Chair, Decision Making Committee
Environmental Protection Authority
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Appendix A: Controls applying to Poncho Votivo
Please refer to the Hazardous Substances Regulations2 for the requirements prescribed for each control and
the modifications listed as set out in this document. The requirements listed below are imposed as controls
under section 77(2). The variations noted are variations to the controls on this substance, not the regulations
generally.
Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations 2001
Code Regulation Description Variation
T1 Regs 11 –
27
Limiting exposure to toxic
substances through the setting
of ADE, PDE and TELs
No ADE, PDE or TEL values are set for any component
of the substance at this time
T2 Regs 29, 30 Controlling exposure in places of
work through the setting of
WESs.
WES values from WorkSafe New Zealand’s Workplace
Exposure Standards and Biological Exposure Indices
Document; 7th Edition; February 20133 have been
adopted for this substance.
T4 Reg 7 Requirements for equipment
used to handle substances
The following clause is added after regulation 7(1)(a)
(1A) The person in charge of this substance must
ensure that it is only applied to seeds using a purpose-
built seed coating machine.
(1B) The person in charge of this substance must
ensure that it is only applied to seeds in a treatment
plant with local exhaust ventilation
T5 Reg 8 Requirements for protective
clothing and equipment
Clause 8(1) is deleted and replaced by the following
clause:
(1) A person who handles this substance or seeds
treated with this substance, or who cleans equipment
used to handle, treat or sow seeds treated with this
substance must use protective clothing or equipment
that is designed, constructed and operated to ensure
that the person -
(a) does not come into contact with the substance; and
(b) is not exposed to a concentration of the substance
that is greater than the workplace exposure standard
for the substance.
(1A) As a minimum a person who handles this
substance or seeds treated with this substance, or who
cleans equipment used to handle, treat or sow seeds
2 The regulations can be found on the New Zealand Legislation website; http://www.legislation.co.nz
3 Document DOL11590.4 FEB13 and any subsequent version approved or endorsed by the EPA. Version 7 is available at
http://www.business.govt.nz/worksafe/information-guidance/all-guidance-items/workplace-exposure-standards-and-biological-exposure-
indices/workplace-exposure-standards-and-biological-indices-2013.pdf
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Code Regulation Description Variation
treated with this substance must wear: long trousers, a
long sleeved shirt, gloves, and eye or face protection.
(1B) A person cleaning equipment used to handle, treat
seeds or sow treated seeds must wear respiratory
protection in addition to other personal protective
equipment specified in (1) and (1A).
T7 Reg 10 Restrictions on the carriage of
toxic or corrosive substances on
passenger service vehicles
E1 Regs 32 –
45
Limiting exposure to ecotoxic
substances through the setting
of EELs
No EEL values are set at this time and the default EELs
are deleted
E2 Regs 46 –
48
Restrictions on use of
substances in application areas
E5 Regs 5(2), 6 Requirements for keeping
records of use
E6 Reg 7 Requirements for equipment
used to handle substances
E7 Reg 9 Approved handler/security
requirements for certain ecotoxic
substances
Hazardous Substances (Identification) Regulations 2001
Code Regulation Description Variation
I1 Regs 6, 7,
32 – 35,
36(1) – (7)
Identification requirements,
duties of persons in charge,
accessibility, comprehensibility,
clarity and durability
I3 Reg 9 Priority identifiers for ecotoxic
substances
I8 Reg 14 Priority identifiers for toxic
substances
I9 Reg 18 Secondary identifiers for all
hazardous substances
I11 Reg 20 Secondary identifiers for
ecotoxic substances
I16 Reg 25 Secondary identifiers for toxic
substances
I17 Reg 26 Use of generic names
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Code Regulation Description Variation
I18 Reg 27 Requirements for using
concentration ranges
I19 Regs 29 –
31
Additional information
requirements, including
situations where substances are
in multiple packaging
I20 Reg 36(8) Durability of information for class
6.1 substances
I21 Regs 37 –
39, 47 – 50
General documentation
requirements
I23 Reg 41 Specific documentation
requirements for ecotoxic
substances
I28 Reg 46 Specific documentation
requirements for toxic
substances
I29 Regs 51, 52 Signage requirements
I30 Reg 53 Advertising corrosive and toxic
substances
Hazardous Substances (Packaging) Regulations 2001
Code Regulation Description Variation
P1 Regs 5, 6,
7(1), 8
General packaging requirements
P3 Reg 9 Criteria that allow substances to
be packaged to a standard not
meeting Packing Group I, II or III
criteria
P13 Reg 19 Packaging requirements for toxic
substances
P15 Reg 21 Packaging requirements for
ecotoxic substances
PG3 Schedule 3 Packaging requirements
equivalent to UN Packing Group
III
PS4 Schedule 4 Packaging requirements as
specified in Schedule 4
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Hazardous Substances (Disposal) Regulations 2001
Code Regulation Description Variation
D4 Reg 8 Disposal requirements for toxic
and corrosive substances
D5 Reg 9 Disposal requirements for
ecotoxic substances
D6 Reg 10 Disposal requirements for
packages
D7 Regs 11, 12 Information requirements for
manufacturers, importers and
suppliers, and persons in charge
D8 Regs 13, 14 Documentation requirements for
manufacturers, importers and
suppliers, and persons in charge
Hazardous Substances (Emergency Management) Regulations 2001
Code Regulation Description Variation
EM1 Regs 6, 7, 9
– 11
Level 1 information
requirements for suppliers and
persons in charge
EM6 Reg 8(e) Information requirements for
toxic substances
EM7 Reg 8(f) Information requirements for
ecotoxic substances
EM8 Regs 12 –
16, 18 – 20
Level 2 information
requirements for suppliers and
persons in charge
EM11 Regs 25 –
34
Level 3 emergency
management requirements:
duties of person in charge,
emergency response plans
EM12 Regs 35 –
41
Level 3 emergency
management requirements:
secondary containment
The following subclauses are added after subclause (3)
of regulation 36:
(4) For the purposes of this regulation, and
regulations 37 to 40, where this substance is
contained in pipework that is installed and
operated so as to manage any loss of
containment in the pipework it—
(a) is not to be taken into account in determining
whether a place is required to have a
secondary containment system; and
(b) is not required to be located in a secondary
containment system.
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Code Regulation Description Variation
(5) In this clause, pipework—
(a) means piping that—
(i) is connected to a stationary container;
and
(ii) is used to transfer a hazardous
substance into or out of the stationary
container; and
(b) includes a process pipeline or a transfer line.
The following subclauses are added at the end of
regulation 37:
(2) If pooling substances which do not have class 1
to 5 hazard classifications are held in a place
above ground in containers each of which has a
capacity of 60 litres or less—
(a) if the place’s total pooling potential is less
than 20,000 litres, the secondary
containment system must have a capacity of
at least 25% of that total pooling potential:
(b) if the place’s total pooling potential is 20,000
litres or more, the secondary containment
system must have a capacity of the greater
of—
(i) 5% of the total pooling potential; or
(ii) 5,000 litres.
(3) Pooling substances to which subclause (2)
applies must be segregated where appropriate to
ensure that leakage of one substance may not
adversely affect the container of another
substance.
The following subclauses are added at the end of
regulation 38:
(2) If pooling substances which do not have class 1
to 5 hazard classifications are held in a place
above ground in containers 1 or more of which
have a capacity of more than 60 litres but none of
which have a capacity of more than 450 litres—
(a) if the place’s total pooling potential is less
than 20,000 litres, the secondary
containment system must have a capacity of
either 25% of that total pooling potential or
110% of the capacity of the largest
container, whichever is the greater:
(b) if the place’s total pooling potential is 20,000
litres or more, the secondary containment
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Code Regulation Description Variation
system must have a capacity of the greater
of—
(i) 5% of the total pooling potential; or
(ii) 5,000 litres
(3) Pooling substances to which subclause (2)
applies must be segregated where appropriate to
ensure that the leakage of one substance may not
adversely affect the container of another
substance.
EM13 Reg 42 Level 3 emergency
management requirements:
signage
Hazardous Substances and New Organisms (Personnel Qualifications) Regulations 2001
Code Regulation Description Variation
AH 1 Regs 4 – 6 Approved Handler requirements
(including test certificate and
qualification requirements)
Hazardous Substances (Tank Wagon and Transportable Containers) Regulations 2004
Code Regulation Description Variation
Tank
Wagon
Regs 4 to 43 Controls relating to tank wagons
and transportable containers
Additional controls
Code Section
of the
Act
Control
Water 77A This substance must not be applied onto or into water4
App Rate 77A No person may apply this substance at a rate greater than 120 mL of Poncho Votivo per
80 000 seeds.
Seed
Treat
77A This substance may only be applied as a seed treatment.
Sch 8 Schedule 8 The requirements of Schedule 8 of the Hazardous Substances (Dangerous Goods and
Scheduled Toxic Substances) Transfer Notice 20045 area applied to this substance with the
following variation. The following clause replaces Clause 1:
4 Where ‘water‘ means water in all its physical forms, whether flowing or not, and whether over or under ground, but does not include
water in any form while in a pipe, tank or cistern or water used in the dilution of the substance prior to application.
5 Available from http://www.epa.govt.nz/Publications/Transfer-Notice-35-2004.pdf
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Code Section
of the
Act
Control
This Schedule applies to every stationary container system that contains, or is intended to
contain the substance.
Seed
Treat
77A Seeds treated with this substance must not be used for human or animal consumption
Dyed
seed 77A Any person treating seeds with this substance must ensure that the seeds are dyed to
differentiate them from untreated seed at the time of treatment.
Seed
Coating 77A Any person treating seeds treated with this substance must ensure that the seeds are film
coated at the time of treatment.
Seed Info 77A Any person supplying seeds treated with this substance must ensure that packages of
treated seeds are accompanied by information that identifies the substance that the seeds
have been treated with, its hazardous properties and precautions to be taken in handling
the seeds
Disposal 77A The controls specified under the Hazardous Substances (Disposal) Regulations 2001 for
this substance are applied to seeds treated with this substance as though the seeds have
the same hazard classification as this substance.
Covered 77A Any person sowing seeds treated with this substance must ensure that the treated seed are
completely covered with soil when sown.
Bird
Access
77A Any person handling or sowing seeds treated with this substances must ensure that treated
seed is not left in areas accessible to birds
Labelling 77A The label of this substance and the label of seeds treated with this substance must specify
the personal protective equipment and respiratory protective equipment that users must
wear when handling the substance, seeds treated with the substance and equipment that
has been used with the substance or seeds treated with the substance.
The label of this substance must include the following statements or words to this effect:
This substance may only be applied in a purpose-built seed coating machine, in a
treatment plant with local exhaust ventilation
A maximum application rate has been set for this substance is 120 mL of this
substance per 80 000 seeds
The label of packages containing seeds treated with this substance must include the
following statement or words to this effect:
Seeds treated with this substance must not be left in areas accessible to birds
Seeds treated with this substance must be completely covered by soil when sown.
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