Staff Presentation
Public Hearing for APP202567
An application to import DuPont Zorvec Enicade
Fungicide
Dr Ivy Robinson
Applications Advisor
Hazardous Substances Team
Background on APP202567
DuPont Zorvec Enicade Fungicide is an oil
dispersion formulation intended to be used to
control downy mildew in onions
DuPont Zorvec Enicade Fungicide contains an
active new to New Zealand, oxathiapiprolin
Lifecycle information
DuPont Zorvec Enicade Fungicide will be imported in 1– 5L containers
The applicant intends that DuPont Zorvec Enicade Fungicide will be
transported by sea, rail and road, and stored in accordance with NZS
8409:2004 Management of Agrichemicals. The applicant intends that
DuPont Zorvec Enicade Fungicide be disposed of by use as a fungicide,
and recommends that waste containers be recycled using the Agrecovery
scheme
DuPont Zorvec Enicade Fungicide is intended to be used by commercial
growers and contractors familiar with safe practices for storing and handling
pesticides. The applicant intends that there would not be domestic or home
use of DuPont Zorvec Enicade Fungicide by untrained users
DuPont Zorvec Enicade Fungicide is intended to be diluted in 200– 500
L/ha of water and applied at a rate of 35 g of the active oxathiapiprolin per
hectare
Application is intended to be by foliar boom spray.
Submissions
Five submissions were received
Three submitters opposed the application:
Ngati Huarere ki Whangapoua Trust
Te Rūnanga o Ngāi Tahu – requested to be heard at a hearing
Ngāpuhi HSNO Komiti – requested to be heard at a hearing, but
subsequently decided not to attend the hearing
Two submitters neither opposed nor supported the
application:
Ngāti Whātua Ōrākei Whai Maia Limited noted that they did not
oppose the application provided that the issues raised in their
submission are given adequate consideration
Beef + Lamb New Zealand Ltd did not support or oppose the
application
Key issues from submissions
Submission from Beef + Lamb New Zealand Ltd
Beef and Lamb noted that agrichemicals are applied to crops that
are fed to food producing animals, and that residues in the resulting
animal products could provide a risk to human health. Trade markets
could also be impacted if those markets do not accept the animal
products due to residues
Submission from Ngati Huarere ki Whangapoua Trust
Ngati Huarere ki Whangapoua have concerns about the impacts of
chemicals where risks are not fully known and understood. They
also had concerns about human safety and aquatic ecotoxicity if
field testing has not been undertaken
As a result, they recommend a precautionary approach until
monitoring of use is undertaken in other countries
Submission from Ngāti Whātua Ōrākei Whai Maia Limited
Ngāti Whātua Ōrākei advocate for an approach to mildew
eradication that does not involve harmful chemicals and do not
support any use of fungicides in their rohe
They consider that use of DuPont Zorvec Enicade Fungicide will
result in depletion and degradation of native biodiversity and
ecological systems, and that this would adversely impact on their
values
Submission from Ngāpuhi HSNO Komiti
Ngāpuhi recommended further investigation on the toxicity of
DuPont Zorvec Enicade Fungicide to aquatic species, and New
Zealand native flora and fauna
Submission from Ngāpuhi HSNO Komiti (continued)
Ngāpuhi are concerned about poor management of chemical sprays
with chronic toxicity, and their impact on the well being of the
whenua and food sourced from aquatic environments (kai roto, kai
awa)
Ngāpuhi consider that improvements can be made by parties
involved in regulating and using hazardous substances to mitigate
risks and ensure compliance with controls and regulations
Ngāpuhi consider that hazardous substance applications fail to
recognise non-target, endangered, or native species. They consider
that practises and beliefs of cultural significance, and Te Tiriti o
Waitangi are not taken into account
Ngāpuhi consider that appropriate consultation was not undertaken,
and consider that the application should be withdrawn until further
evidence is provided that risks to Māori have been fully investigated
and mitigated
Submission from Te Rūnanga o Ngāi Tahu
Ngāi Tahu criticised the application for not including a draft label for DuPont
Zorvec Enicade Fungicide in the publicly available material
Ngāi Tahu criticised the application for not discussing tank mixing of DuPont
Zorvec Enicade Fungicide with other fungicides prior to application. They
consider that the application should have included a risk, cost and benefit
analysis of use of DuPont Zorvec Enicade Fungicide in tank mixes
Ngāi Tahu criticised the section of the application on Māori culture and the
relationship of Māori to the environment as comprising of toxicology and
ecotoxicology data rather than assessing risks, costs and benefits to Māori
Ngāi Tahu are concerned that because the formulation has low solubility in
water it has aquatic ecotoxicity properties that are difficult to assess
Ngāi Tahu consider that the application should be declined, but, if not
declined, that conservative buffer zones should be applied to manage risks
from aquatic ecotoxicity
Staff response to submissions
Residues in animal products
Pesticide residues in animal products and their impact on human
health and animal products are the regulatory responsibility of
ACVM and are outside the scope of HSNO approvals
Field testing
EPA staff consider that the effects of DuPont Zorvec Enicade
Fungicide can be evaluated from the test data available, and
quantitative modelling of the expected exposure of the substance to
workers, bystanders and re-entry workers
We consider that these exposures are below levels that would cause
harm and that it is not necessary to undertake field testing and
monitoring for human health and environmental impacts prior to
approval
Staff response to submissions (2)
Aquatic ecotoxicity and native species
The staff undertook quantitative modelling of the risks to aquatic organisms
and terrestrial flora and fauna
This modelling takes into account the potential for native flora and fauna to
be more sensitive than organisms used in testing
The modelling indicated that exposures to native flora and fauna are
expected to be below levels that would cause adverse effects
In the assessment, studies on the formulation took the low solubility of the
active into account by expressing the toxicity based on measured
concentrations
Risks to Māori and impacts on mahinga kai
The staff consider that adverse effects on mahinga kai (traditional food
sources) species are not expected
We consider that there will not be any significant impact on culturally
important taonga species
Staff response to submissions (3)
Information
The staff consider that the draft label for the substance can be confidential
to the applicant. The staff note that draft labels can be subject to significant
revision depending on the outcome of the EPA decision and may contain
information that is commercially sensitive at the time of application
The staff note the concerns of Ngāi Tahu that the application did not include
an assessment of the cultural risks to Māori, with this section of the
application form essentially consisting of a detailed discussion of the
environmental risks
The staff report provides a detailed risk assessment of the human health
and environmental risks of DuPont Zorvec Enicade Fungicide. This risk
assessment was used to inform an assessment of the risks to the
relationship of Māori to the environment
The staff note that the applicant provided information to the Te Herenga
network prior to formal receipt and public notification of the application
Staff response – tank mixes
Tank mixes
The staff acknowledge that there may be uncertainty with respect to
synergistic or antagonistic effects as a result of tank mixing pesticide
formulations
The staff note that use of combinations of pesticide actives is
standard agricultural practise used to minimise the total number of
applications of substances and to aid in management of pest
resistance to pesticide actives
Pesticide actives are divided into compatibility groups to avoid
known issues in tank mixes such as loss of efficacy, physical effects
that can cause damage to equipment, actives that are prone to
development of cross-resistance or increased toxicity
Staff response – tank mixes (2)
The scope of the Act is limited to issuing or not issuing an approval
for the substance that is the subject of the application. Hazardous
substances used in a tank mix with DuPont Zorvec Enicade
Fungicide will be subject to conditions on their own approval under
the Act
No information is available in the application about potential affects
from tank mixing DuPont Zorvec Enicade Fungicide with other
pesticide formulations
No information is available that indicates that there is a risk to be
managed from tank mixing that would not be covered by controls on
DuPont Zorvec Enicade Fungicide and the controls on the other
substances included in tank mixes
The staff note that it may not be feasible to obtain data on all
possible combinations of pesticides applied together in tank mixes
Hazard classifications
The staff classified oxathiapiprolin as 9.1A (aquatic ecotoxicity). This
classification was based on test data on toxicity to Daphnia magna.
The staff classified DuPont Zorvec Enicade Fungicide as 6.3A (skin
irritant), 6.5B (contact sensitisation), and 9.1D (biocidal action).
These classifications were determined from test data on DuPont
Zorvec Enicade Fungicide. The biocidal classification is applied
because DuPont Zorvec Enicade Fungicide does not have any other
ecotoxicity classification (class 9), and it is intended for biocidal use
(as a fungicide).
Human health risk assessment
The staff conducted a quantitative risk assessment for DuPont
Zorvec Enicade Fungicide
This showed that the modelled exposures to operators, re-entry
workers, and bystanders are below the acceptable operator
exposure level (AOEL).
No personal protective equipment is required to reduce exposure to
less than the AOEL, but the staff consider it is appropriate to retain
requirements for PPE as DuPont Zorvec Enicade Fungicide is
classified as a skin irritant and contact sensitiser
The staff consider that with the controls in place, the risks to workers
and bystanders from the use of DuPont Zorvec Enicade Fungicide
are negligible
Risks during the non-use phases of the lifecycle of DuPont Zorvec
Enicade Fungicide were qualitatively assessed as negligible
Environmental risk assessment
The staff conducted a quantitative assessment of the
ecotoxicological risks of DuPont Zorvec Enicade Fungicide
The staff determined that the acute and chronic exposures to
aquatic organisms, earthworms, sediment-dwelling organisms, nontarget plants, birds, bees and non-target arthropods are below levels
of concern and so the risks are considered negligible
There is also not expected to be a risk to ground water
Risks to the relationship of Māori to the environment
DuPont Zorvec Enicade Fungicide has hazardous properties that
could lead to cultural risk. The staff have determined that the risks to
taha hauora (human health) are not likely to be significant given the
use pattern and the controls proposed by staff
The active ingredient in DuPont Zorvec Enicade Fungicide has
toxicity to aquatic environments, and therefore could impact on
taonga species, in particular species associated with mahinga kai
(food resources)
The staff note that based on the environmental risk assessment,
DuPont Zorvec Enicade Fungicide is not expected to cause harm to
mahinga kai species
Benefits
The applicant considers that DuPont Zorvec Enicade
Fungicide will provide significant benefits associated
with:
Improved crop health, and prevention of yield loss
Associated financial benefits for growers
The new active with an alternative mode of action will be useful in
disease resistance management
Lower risks to aquatic environments than other existing fungicides
Staff assessment of benefits
The staff accept that there will be financial benefits to some
companies associated with the approval of DuPont Zorvec Enicade
Fungicide
The staff agree that the approval of DuPont Zorvec Enicade
Fungicide provides an additional fungicide active with a different
mode of action to existing fungicides, and that it presents a useful
option for resistance management
The staff consider that the lower hazard profile compared to existing
fungicides and the negligible risks to human health and the
environment are significant benefits
Product
Actives
Concentration
Application
Rate/ha
Typical product hazard classification
Zorvec Enicade
oxathiapiprolin
100 g/L
35 g
6.3A, 6.5B, 9.1D (biocide)
Acrobat, Cobra and
others
dimethomorph
Up to 500 g/kg
90 – 180 g
6.9B (oral), 9.1B
Ridomil Gold, Helios
and others
metalaxyl
250 g/L
160 g
3.1C, 6.1D (oral, inh.), 6.3A, 6.4A, 6.5B,
6.8B, 6.9B (oral, inh.), 9.1C, 9.3C
Max Cl, Cobra and
others
chlorothalonil
Up to 720 g/L
900 g
180 g
6.1B (inh.), 6.3B, 8.3A, 6.5B, 6.7B, 6.9A
(oral), 9.1A, 9.2B, 9.3B
Nautile, Curfew and
others
cymoxanil
300 g/L or 450
g/kg
111 – 150 g
6.1E (oral), 6.3B, 6.4A, 6.5B, 6.9B (oral),
9.1B, 9.2D, 9.3C
Amistar, Tazer and
others
azoxystrobin
250 g/L
500-800 g/kg
125 g
250 g/L formulation: 6.1D (oral), 6.3B,
6.4A, 6.9B (oral), 9.1A
Acrobat, Nautile and
others
mancozeb
various
Up to 2 kg
6.3B, 6.4A, 6.5B, 6.9B (oral), 9.1A
Reason
fenamidone
500 g/L
150 g
6.9B (oral), 9.1A, 9.2D
Revus
mandipropamid
250 g/L
100 – 150 g
6.9B (oral), 9.1D
BacStar
Bacillus subtilis
250 g/kg
Cusol, Nordox and
others
Several salts
various
6.5B, 9.1D (biocide)
Up to 5 kg/ha
6.1D (oral, inh.), 6.3A, 8.3A, 6.5A, 6.5B,
6.8B, 6.9B (oral, inh.), 9.1A, 9.3B
Sources: NZ Novachem Agrichemical Manual 2013, ACVM Register, and EPA
Controls
Default controls triggered by the classification of the
substance are used as the basis for the controls on this
substance
Variations proposed to the default controls include the
setting of acceptable daily exposure (ADE) and potential
daily exposure (PDE) values.
A number of additional controls are proposed under
section 77A of the HSNO Act 1996 that the staff consider
will provide better management of the risks of the
substance
Controls
Proposed additional controls:
A maximum application rate of 350 mL formulated product/ha
(equivalent to 35 g oxathiapiprolin/ha), maximum of 2 applications
per year, and a minimum interval between applications of 10 full
days – based on the intended use pattern described by the
applicant
Restriction to ground-based application methods only and
restriction against application onto or into water
A re-entry interval where PPE is required until the spray has dried
Label information control to communicate these requirements to
users of the substance
An impurity control on the level of methanol in the technical grade
oxathiapiprolin
Overall recommendation
The staff consider that with the proposed
controls in place, the level of risk to human
health and the environment will be negligible
The staff consider that the level of risk to Māori
culture, and to society, community and the local
economy will be negligible
The staff recommend that the application to
import or manufacture DuPont Zorvec Enicade
Fungicide be approved