DECISION - EPA...Summary Substance Poncho Votivo ... Transmission of clothianidin into pollen and...

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

2

EPA Decision on Application for approval to import or manufacture Poncho Votivo for release (APP202077)

8 July 2016

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

3


8 July 2016

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.

4


8 July 2016

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.

5


8 July 2016

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.

6


8 July 2016

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.

7


8 July 2016

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).

8


8 July 2016

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.

9


8 July 2016

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

10


8 July 2016

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

11


8 July 2016

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

12


8 July 2016

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.

13


8 July 2016

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.

14


8 July 2016

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

http://www.epa.govt.nz/search-databases/HSNO%20Application%20Register%20Documents/APP202077_APP202077_EandR_FINAL_for_web.pdf

http://www.epa.govt.nz/search-databases/HSNO%20Application%20Register%20Documents/APP202077_APP202077_EandR_FINAL_for_web.pdf

15


8 July 2016

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.

16


8 July 2016

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.

17


8 July 2016

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

18


8 July 2016

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.

19


8 July 2016

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

20


8 July 2016

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.

21


8 July 2016

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.

22


8 July 2016

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.

23


8 July 2016

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

24


8 July 2016

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

http://www.legislation.co.nz/

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

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

25


8 July 2016


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


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

26


8 July 2016


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


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

27


8 July 2016

Hazardous Substances (Disposal) Regulations 2001


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


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


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.

28


8 July 2016


(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

29


8 July 2016


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


signage

Hazardous Substances and New Organisms (Personnel Qualifications) Regulations 2001


AH 1 Regs 4 – 6 Approved Handler requirements

(including test certificate and

qualification requirements)

Hazardous Substances (Tank Wagon and Transportable Containers) Regulations 2004


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

http://www.epa.govt.nz/Publications/Transfer-Notice-35-2004.pdf

30


8 July 2016

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.

DECISION - EPA...Summary Substance Poncho Votivo ... Transmission of clothianidin into pollen and...

Documents

Transcript of DECISION - EPA...Summary Substance Poncho Votivo ... Transmission of clothianidin into pollen and...