SUBMISSION FORM
Proposed risk assessment methodology for hazardous
substances
Please submit your comments to [email address] on this form in Word document
format or use the on-line submission form at www.epa.govt.nz
Feedback on
Proposed risk assessment methodology for hazardous substances
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Syngenta Crop Protection Limited
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+61 438 692 333
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[email address]
Proposals and submission form
The EPA is seeking your views as interested parties on the proposals presented in the
Assessing the Risks
of Hazardous Substances and
Risk Assessment Methodology for Hazardous Substances documents. The
EPA is consulting you to be transparent in how we do things as a proactive regulator, and as part of our
Customer Centricity themes
Keep me informed,
Engage with me and
Be helpful & treat me fairly.
Please use this form to provide your written feedback and send it to [email address] in
Word document format no later than 5pm on Friday 6 July 2018. Alternatively, you can use the online
submission form on the EPA website at www.epa.govt.nz
The consulation document poses a series of questions that we would like your feedback on. Your response
to the questions in the table below are welcomed. You may focus on the questions that are relevant to you,
as you are not required to answer all of them.
When providing your comments, please provide your rationale and any additional information you consider is
relevant. This information will help us more fully understand the effects the proposed methodology will be
likely to have if introduced as currently proposed.
Your feedback is important as it will enable the EPA to make more informed decisions on the final content of
the proposed methodology. Please take this opportunity to have your say.
Feedback may be made publicly available
The Environmental Protection Authority (EPA) may publish all or part of your feedback on its website at
www.epa.govt.nz. Providing feedback implies that you consent to such publication, unless you clearly
specify otherwise in your feedback.
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The Privacy Act 1993 establishes certain principles with respect to the collection, use, and disclosure of
information about individuals by various agencies, including the EPA. Any personal information you supply in
the course of making a submission will be used only in conjunction with the matters covered by this
document. We may also use your contact details for the purpose of requesting your participation in customer
surveys. You may request that your personal information (other than your name) be withheld from publicly
available information.
Disclaimer
This document does not alter the laws of New Zealand. The EPA does not accept any responsibility or
liability to any person, whether in contract, equity or tort, or any other legal principle, for any direct or indirect
losses or damage arising from reliance on the contents of this document.
Page 2 of 6
Please submit your comments to [email address] in Word document format or via the
online submission form no later than 5pm on Friday 6 July 2018.
For the “Assessing the Risks of Hazardous Substances” summary document:
Question
Page
Question
Your comments/notes and rationale
number
number
Is the level of detail
1
appropriate?
Are there any areas that you
2
would like more information
on?
For the main text of the “Risk Assessment Methodology for Hazardous Substances” document:
Question
Page
Question
Your comments/notes and rationale
number
number
Is the level of detail
3
appropriate?
Are the technical aspects
ADE vs ADI; exposure vs intake.
4
27
Generally acceptable daily intake is known as ADI not ADE. ADE is acceptable daily exposure. In the context of
correct?
this section “acceptable daily exposure (ADE)’ should be used.
“… All of the relevant regulatory reviews must be provided, along with the original studies…”
Are there any areas that
Which particular regulatory agencies are considered relevant to NZ? Those that are considered most relevant
8, 3rd
5
and most reliable for their standard of scientific assessment and reporting should be clearly listed in the
need more guidance?
para
document. Further, we believe this should be optional and left to the applicant to decide whether to include any
overseas reviews or not.
24
“… Threatened and at risk species…”
Page 3 of 6
Please submit your comments to [email address] in Word document format or via the online submission form no later than 5pm on
Friday 6 July 2018.
Question
Page
Question
Your comments/notes and rationale
number
number
EPA needs to clearly define what species are considered threatened or at risk and clearly define the locations
where such protection measures are considered necessary. Otherwise, the approach treats all of New Zealand
as a sensitive area. Clear guidelines are required on what the additional safety factors are.
Are there any other matters
6
that should be addressed as
part of this methodology?
For the technical appendices of the “Risk Assessment Methodology for Hazardous Substances” document:
Question
Page
Question
Your comments/notes and rationale
number
number
Are there alternative
groundwater models that the
7
EPA could consider as part
of a revised groundwater risk
assessment framework?
Is the level of detail
8
appropriate?
Are the technical aspects
9
correct?
Are the requirements
10
practical and achievable?
When used in conjunction
11
with the external guidelines
Page 4 of 6
Please submit your comments to [email address] in Word document format or via the online submission form no later than 5pm on
Friday 6 July 2018.
Question
Page
Question
Your comments/notes and rationale
number
number
for each model, is any
further clarification required
to be able to perform a risk
assessment?
Are the parameter values
71
Water rates for agricultural spraying varies from 20L up to 100L/ha with the average being 50 to 60 litres.:
12
used by the EPA relevant
and correct?
Side slope angle: some crops are grown on slopes and not flat terrain, eg vegetables grown in Pukekohe in the
72
North Island and some vineyards are on a slope as well as forage brassicas. Consideration needs to be allowed
for these in parameters for AgDISP modelling.
GENEEC2. This model no longer exists on the USEPA website. Information about GENEEC2 has been
Are the models used by the
archived and the model is not currently supported. It has mostly been replaced with the Pesticide in Water
13
60
Calculator (PWC), which is referenced in section C.5.8 (p77). We agree that the Pesticide in Water Calculator is
EPA relevant and correct?
more complicated than GENEEC2 and not the preferred option for a screening level assessment. EPA would
need to ensure applicants and other interested parties can access GENEEC2 if is is going to be used.
AgDRIFT and APVMA. APVMA are moving away from using AgDRIFT for ground based application in favour of
AgDISP. They are developing revised ground application components (parameters in the model) for AgDISP.
63
If AgDRIFT remains as the preferred model in NZ, which version does EPA propose to use? The current
available version is 2.0.09.
There is currently work underway to refine the AgDISP model for ground application. APVMA are in the process
69
of developing principles to use AgDISP for ground application modelling.
On page 60 the model for run-off is GENEEC2. In this section, EPA refer to RexTox. What is the intended
approach? Is the intention to go from GENEEC2 to RexTox for higher tier modelling? If so, can EPA provide
74
guidelines for appropriate triggers for going from GENEEC2 to RexTox? Or is this to be on the basis of when
further refinement of exposure is required.
Page 5 of 6
Please submit your comments to [email address] in Word document format or via the online submission form no later than 5pm on
Friday 6 July 2018.
Question
Page
Question
Your comments/notes and rationale
number
number
Section C.8.2 – spray drift modelling using BBA. This seems to an inconsistent approach. In other sections,
EPA have referenced AgDRIFT and AgDISP modelling for spray drift. It would be preferable to have one
83
consistent model for assessing spray drift or clear guidelines / thresholds as to when the different models should
be used.
Section C.12 – Regarding use of he SCI-GROW model, there are a number of other models that can be used for
groundwater assessment but most are complex, data hungry and tailored to their specific locations e.g. the EU
Focus GW models. Syngenta’s experience is that the SCI-GROW model has proven over the years to be a
useful screening level tool to give reasonable estimates for risk assessment. However, if it becomes necessary
96
to refine this number for higher tier assessment of groundwater exposure EPA should provide some guidance on
acceptable methodology.
As with some other models, SCI-GROW is no longer supported by the USEPA and has been archived. EPA will
need to ensure that if the model is used that applicants and other interested parties will have access to the
model.
Are there any alternate
models (other than that for
14
the effects on groundwater)
that the EPA could consider?
Page 6 of 6
Please submit your comments to [email address] in Word document format or via the online submission form no later than 5pm on
Friday 6 July 2018.
