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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Bayer New Zealand Limited
P.O. Box 2825, Shortland Street, Auckland 1140
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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
4
correct?
Are there any areas that
5
need more guidance?
Are there any other matters
6
that should be addressed as
part of this methodology?
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.
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?
EPA:
“A number of parameter values from the 2014 EFSA operator, worker, resident and bystander exposure
model (EFSA, 2014) are used as they are more recently available. This model is not currently used because of
page 42
concerns over the applicability of the assessment of bystanders from aerial applications to the use patterns in
B 4.8.
New Zealand.” This statement does not give a sufficient argumentation why the EFSA model is not used because
Are the technical aspects
9
neither the AOEM nor the UK version of the BBA model include any recommendations for calculating operator or
correct?
bystander exposure during aerial applications.
EPA states that a default foliar half life of 10 days can be used according to EFSA 2014. However, EFSA 2014
page 44
proposes to use a default foliar half life of 30 days. The default proposal of US EPA is a 10% dissipation of foliar
B 5.3.
residues per day. A default foliar half-life of 10 days is proposed by FOCUS 2003 (as stated in Table B.5).
The 0.1µg/l limit for pesticides/relevant metabolites is arbitrary and not risk-based as implied by the section
header (“Risk”). It is highy recommended to follow a scientifically, health-based approach for deriving thresholds
in groundwater. The WHO proposes such a reasonable approach
(http://www.who.int/water_sanitation_health/publications/2011/dwq_guidelines/en/). For pesticides it is suggested
Are the requirements
to calculate a guideline value (GV) that should not be exceeded in groundwater (drinking water):
10
96
practical and achievable?
𝐴𝐷𝐼 × 𝑏𝑤 × 𝑃
𝐺𝑉 =
𝐶
where:
ADI: acceptable daily intake
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
bw = body weight (adult: 60 kg)
P = fraction of the ADI allocated to drinking-water (20%)
C = daily drinking-water consumption (adult: 2 l)
The guideline value can in turn be compared to the result of the groundwater leaching model. If the predicted
environmental concentration in groundwater is smaller than the GV, the health risk assessment for groundwater
(drinking water) is successfully passed. Otherwise further refinement options or adjustment of the use pattern
may be required.
When used in conjunction
with the external guidelines
EPA does not give any recommendation how to calculate operator exposure for aerial applications. For
for each model, is any
estimating the exposure during aerial application, we recommend to follow the approach proposed by the US
page 39
11
EPA. Dermal and inhalation unit exposures for mixing and loading from the “Occupational Pesticide Handler Unit
further clarification required
B 4.2.
Exposure Surrogate Reference Table” can be applied
(https://www.epa.gov/sites/production/files/2016-
to be able to perform a risk
11/documents/handler-exposure-table-2016.pdf).
assessment?
Are the parameter values
12
used by the EPA relevant
and correct?
EPA proposes to use the UK CRD version of the BBA Operator Exposure Model. However, in the past years, the
AOEM was developed as the appropriate operator exposure model to be used in Europe. It includes state-of-the
page 39
art application techniques and compared to the BBA model, is based on a more robust dataset. All other criteria
B 4.2.
listed on page 39 with regard to a suitable operator exposure model also apply to the AOEM. Therefore, we
propose to use the AOEM rather than the BBA model for operator exposure calculation.
Are the models used by the
13
EPA relevant and correct?
EPA recommends a combination of the EFSA model and the US EPA model for residential exposure to calculate
exposure to bystanders after commercial pesticide use. However, in our opinion, combining different assumptions
page 47
from different models does not seem very appropriate. We propose to follow the US approach for residential
B 6.2.
exposure. The US EPA Residential SOPs use the most reliable scientific data available. The potential risk
estimates from residues depositing on surfaces can be calculated using drift modelling (AG Drift) for all
application scenarios (aerial, groundboom, airblast) coupled with methods employed for residential risk
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
assessments for turf products
(https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-
operating-procedures-residential-pesticide;
https://www.regulations.gov/contentStreamer?documentId=EPA-HQ-OPP-2013-0676-0003&contentType=pdf)
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.
