Application for approval of Poncho Votivo

Application for approval of
Poncho Votivo
Tonde Kaitano (Regulatory Affairs Manager)
Pete Fisher (Stewardship Manager)
Christian Maus (Global Pollinator Safety Manager)
3 December 2015
Agenda
1. Who we are;
2. How we develop Crop Protection Products;
3. Poncho Votivo & its lifecycle;
4. Risks and benefits of Poncho Votivo;
5. The EU situation;
6. Benefits of Poncho Votivo outweigh its risks.
Bayer – Science for a better life
Innovation vital to safeguard harvests and
secure food supply...
Actual
losses
Major crops analyzed:
rice, wheat, barley, corn,
potatoes, soybeans, cotton, coffee
Prevented
losses
30%
Yield without
crop protection
Today
58%
Due to
pests,
weeds
and
diseases
100%
42%
By pests,
weeds and 28%
diseases
Actual yield with
crop protection
Theoretically
attainable yield
Nearly half of the current harvest would be lost without crop protection
Through innovation and adequate use of crop protection solutions,
total yield could be almost doubled  Bayer passionate about this
Source: Oerke et al., Crop Production and Crop Protection, Elsevier, Amsterdam, 1994
Bayer products helping NZ farmers grow
world record crops
1. Bayer products assisted a Timaru farmer grow world record barley
in 2015;
2. 12.2 t/ha (Scottish Farmer, 1989)  13.8 t/ha, Warren Darling,
Timaru, 2015
We thoroughly study & test our products
before registration
Active ingredient Synthesis
Process development
Chemistry
Synthesis optimisation
Pilot plant production
Formulation / Packaging
Formulation
Research Laboratory / Greenhouse
Biology
Profiling & positioning trials
Efficacy trials for Registration
Development
Acute, sub-chronic, chronic toxicity
mutagenicity, carcinogenicity, teratogenicity, reproduction
Mammals
Toxicology
Algae, daphnia, fish, birds, microorganisms,
bees, non-target organisms
Ecosystems
Metabolism
Soil, water, plants, animals , air
Environment
Plants, animals, soil, water
Residues
Year
0
~NZ$ 500m
Authority Evaluation
Submission
1
Leads >>50,000 500
2
3
4
5
10
3
2
1
6
7
8
9
Launch
Background on the Application
- 98 g/L CTD
Poncho Votivo (508
Poncho
7.24x1010
g/l CTD +
CFU/l BFi)
(CTD 600 g/l)
CTD = clothianidin,
a neonicotinoid
first registered in
NZ 06/06/2003
+ BFi
7.24x1010 CFU/L
Crops: maize, sweetcorn,
cereals, forage brassicas
& grass seed
BFi = Bacillus firmus; naturally
occurs in NZ soils
Overseas Approvals – CTD:
 Australia;
 North America;
 EU (with restrictions);
 Japan, RSA, etc.
Overseas Approvals – BFi:
 North America;
 EU, RSA etc
Application
submitted 2014
Variation: focus on maize
and sweetcorn only
Public
submissions
Consideration
and decision
Hearing
3 December 2015
We welcome the
opportunity to address
concerns raised by
submitters
Poncho Votivo is safely manufactured,
shipped and applied
AGCARM and NZGSTA
Stewardship Guides
Poncho Votivo controls critical pests
Argentine stem weevil (ASW)
Black beetle
Targets
Plant-parasitic nematodes
Letter form Foundation
For Arable Research
underscores importance
of controlling these pests
Greasy cutworm
Clothianidin protects the seed & young plant
1
CONTACT EFFECT
AGAINST SOIL PESTS
2
3
CONTROL OF
SOIL PESTS
CONTROL OF
FOLIAR PESTS
Bacillus firmus boosts overall plant health
Root
Nematodes
Bacterial film
Maize plant
Bacteria
Plant sugars
Bacterial enzymes
Nematode eggs
Bacterial phytohormones
Are there risks with Poncho Votivo?
Operator and
bystander exposure?
Exposure of non-target
organisms like bees via
generated dust?
Bee exposure via
pollen?
Exposure of non-target
organisms via residues in
soil and water?

Poncho Votivo hads a high level of safety for people and the
environment when used in accordance with label instructions
Managed honey bees are flourishing
CTD seed treatments
safely used in NZ since
2003
Managed hives
increased by 80% as
of Feb 2015
Honey bees also
thriving in Australia,
despite neonics use
Varroa mite
discovered 2000
Feral honey bees
wiped out
Beehive numbers increasing in NZ
NZ Totals – Number of Registered Beekeepers, Apiaries and Beehives 2000-2015
80,000
Beekeepers
Apiaries
Hives
550,000
500,000
60,000
50,000
450,000
40,000
400,000
30,000
350,000
20,000
300,000
10,000
0
250,000
2000
2001
2002
2003
2004
2005
Source: The New Zealand Beekeeper: April 2014, Volume 22, No.3.
2015 data National Pest Management Strategy afb.org.nz
Stats as at: J-June, F- February
2006
2007
2008 2009(J)* 2010(J) 2011(J) 2012(J) 2013 (F)2014 (F)2015 (F)
Hives
Beekeepers and Apiaries
70,000
Poncho Votivo has a high level of safety for
people and the environment
Low mammalian
toxicity
Dust-off risk negligible –
film coating and fluency
agents
Field studies: pollen
exposure negligible
Traces of clothianidin in
the environment do not
represent risk
Controls under HSNO Act
and product stewardship
further reduce risk

Overall, Poncho Votivo is safe for people and the environment when
used in accordance with label instructions
Benefits: Poncho Votivo provides
outstanding control of Argentine stem weevil
1. Argentine stem weevil (ASW)
burrows into plant stem;
2. Impossible to control with
non-systemic insecticides;
3. By the time you see ASW
damage  too late
4. Yield losses can be >30%;
5. Without neonics, up to 6
weeks fallow required before
planting maize  productivity
loss.
Benefits: Poncho Votivo provides excellent
control of greasy cutworm
1. Foliar insecticides can be
effective, but may need
more than 1 application
depending on pest pressure;
2. Yield loss can be >>20%;
3. Sporadic attacker – not
localised.
Benefits: Poncho Votivo provides excellent
control of black beetle
1. Only alternative is very
hazardous & performs
poorly.
2. No foliar insecticide
registered for black beetle
control
3. Yield loss can be >10% if
black beetle not controlled.
Benefits: Poncho Votivo boosts plant health
Nematodes
attack plant
roots:
B. firmus protects maize plants from
nematodes attack and boosts overall plant
health.
Benefits: Maize is an important crop in
pastoral agriculture
1. Livestock & dairy = 60% of
2.
3.
4.
5.
NZ exports;
Maize yields high dry matter
in a short time period;
A high quality forage
supplement;
An important break crop in a
pasture renewal cycle 
higher performing pastures;
Limits importation of palm
kernel.
Benefits: Clothianidin is applied at much
lower rates, unlike the alternatives
Foliar treatment
with chlorpyrifos
300
Seed treatment with
In-furrow treatment
with phorate granules clothianidin
2,000
90
Benefits: Poncho Votivo may eliminate
several foliar applications
Treatment of
area
CTDwhole
active
~6
weeks
Yield up to
48% >
untreated
Foliar spray eliminated
Benefits: Operator & Environmental Safety
Example Product &
Approval No.
Poncho Votivo
Application type
HSNO classification
Seed treatment
6.1D, 6.3B, 6.4A, 6.5B, 6.9B,
9.1A, 9.2B, 9.3B, 9.4A
Furakote EW
Seed treatment
HSR000943
Counter 20G HSR000216 Soil application
6.1B, 6.3B, 6.4A, 6.5B, 6.9A,
9.2B, 9.3A, 9.4A
6.1A, 6.8B, 6.9A, 8.2C, 8.3A,
9.1A, 9.3A, 9.4C
6.1A, 6.8B, 6.9A, 9.2B, 9.3A,
9.4B
3.1D, 6.1D, 6.3B, 6.4A, 6.8B,
6.9A, 9.1A, 9.2D, 9.3A, 9.4A
3.1D, 6.1C, 6.3B, 6.4A, 6.8B,
6.9A, 9.1A, 9.2B, 9.3A, 9.4A
3.1D, 6.1B, 8.2C, 8.3A, 6.9A,
9.1A, 9.2B, 9.3A, 9.4A
3.1D, 6.1D, 6.3B, 6.9B, 9.1A,
9.3B, 9.4A
6.1B, 6.3B, 6.4A, 6.9A, 9.1A,
9.3B, 9.4A
Phorate 20 G
HSR000210
Grub Buster Diazinon
HSR100878
Chlorpyrifos 500EC
HSR000224
Metafort 60SL
HSR000226
Dominex 100
HSR000293
AGPRO Lambda
cyhalothrin HSR100578
X
Band application
at sowing
Foliar (boom &
aerial)
Foliar (boom &
aerial)
Foliar (boom &
aerial)
Foliar spray
Foliar spray
Active
ingredient
508 g/L CTD,
102 g/L BFI
Class
Biologic +
neonic
400 g/L
Carbamate
furathiocarb
200 g/kg
OP
terbufos
200 g/kg phorate OP
Max. a.i. rate
g/ha
90 CTD,
1.3 x 1010 cfu
BFI
300
Apps
seaso
1
1,500
*
2,000
*
1
800 g/L diazinon
OP
2,400
**
500 g/L
chlorpyrifos
600 g/L
methamidophos
100 g/L αcypermethrin
250 g/L cyhalothrin
OP
625
**
OP
600
**
SP
20
**
SP
10
**
Alternatives are more toxic, have limited spectrum and effectiveness,
and may require up to 6 weeks fallow
Commentary on Submissions and
the
EU
Situation
regarding
neonicotinoids
Higher-Tier Studies to Evaluate Effects of
Clothianidin to Bees
 Risk assessment for clothianidin is mainly based on higher-tier studies (=
tests with a realistic or near-realistic design where bees are tested in the
context of their entire colony (e.g. tunnel, field); results more significant
for risk assessment than laboratory data
 For clothianidin, more than 50 higher-tier studies have been conducted
 These studies are complemented by numerous trials investigating
residue levels in nectar/pollen (direct treatment and succeeding crop
scenarios)
 Succeeding crops: according to all available data, residues in succeeding
crops lower or at maximum as high as in directly treated crops
 Overall endpoint (colony NOAEC field) identified for clothianidin: 20-25
μg/kg
 Residue findings typically found in nectar and pollen of seed-treated
crops are between 1 and 5 µg/kg
 In no studies were adverse effects seen under realistic exposure
conditions
Exemple Large-Scale Field Study (Corn)
Three-year multi-location field study in France
Study to address chronic exposure of bees to systemic residues of
clothianidin resulting from seed treatment in maize pollen at four field
sites in France with control vs. treatment.
No treatment-related effects detected, control and treatment colonies
essentially performed equally well, including overwintering success
Field monitoring study in Southwestern Germany
Five monitoring locations, three with bee hives. Colony health and
development was followed up and monitored during and after
flowering including over-wintering assessment. Residue analysis of
corn pollen from treated corn on 50 fields at 5 different locations and
pollen samples from pollen traps at beehives next to the fields
During and after the exposure phase, including overwintering, no
adverse treatment-related effects were observed
Sublethal Effects – A Key Topic of the Public
Discussion
Numerous studies have been published that describe sublethal effects caused
by Neonicotinoids
Some points to consider:
 Realism of exposure scenario – most studies have been conducted with
laboratory exposure, forced feeding, no-choice exposure, or otherwise
exaggerated exposure concentrations
 Relevance of effects – practically every change compared to an untreated
control group has been defined as a sublethal effect - relevance for
individual (or population) vitality? Not every sublethal effect is necessarily
an adverse effect
 Relevance of effects on individual vs. colony level - after 15 years of
intense research, still nobody has been able to show any damage on
colony level caused by sublethal effects of clothianidin and other
neonicotinoids in a realistic exposure scenario.
 Specificity of effects – very little is known about sublethal effects caused
by compounds other than neonicotinoids
Exposure to Dust
 From seeds treated with certain coating techniques, small quantities of
insecticidal dust from the coating may be abraded, especially when the
coating is of poor quality
 Those may be emitted to the environment during planting, in particular
when vacuum-pneumatic drilling machines of certain types are used
 There have been a few cases where strong dust formation due to
improper seed treatment led to dust emission and bee damage
 This potential exposure route is well known, and in the last seven years,
major technical improvements have been made to minimize dust emission
on the level of seed treatment and coating technology, planting
machinery, and handling / stewardship for treated seeds
 With these measures, dust emission can be reliably reduced to safe levels
 No New Zealand reports of honey bee related incidents from dust-off from
neonicotinoid treated seed
Guttation
 Guttation, the active excretion of liquid water by plants as droplets, is a
natural botanical phenomenon
 Guttation fluid does not contain sugar and is therefore not intrinsically
attractive to bees as carbohydrate source
 Guttation of neonicotinoid-seed treated plants in the seedling stage can
contain high substance concentrations
 To investigate whether guttation is of relevance as water source for bee
colonies and as route of exposure to neonicotinoids, numerous and
extensive field studies have been conducted
 Results show that guttation fluid is not normally a water source of
significant importance for bee colonies
 Though individual bees may under certain circumstances collect
guttation water, damage to exposed bee colonies was never observed
 It can therefore be concluded that guttation of neonicotinoid seedtreated crops does not constitute a significant risk to bee colonies
The Restriction in EU - EFSA reports 2013
Key facts on the EFSA reports
European Food Safety Authority (EFSA)
published reports on the risks of three
neonicotinoids1 to bees (seed treatment and
granular products only) on Jan 16th, 2013:
-
Not based on new information
-
Concluded risks and data gaps for many
uses
-
EFSA did not demand any product bans,
no risk management remit
1
Imidacloprid, Clothianidin (both BCS) and Thiamethoxam (Syngenta)
Reasons for unfavorable risk conclusion:
 more conservative, but as yet
unvalidated criteria were applied
 numerous studies conducted under
relevant field conditions were not
considered for risk conclusions
 comprehensive monitoring data from
all over Europe were omitted
 significant stewardship improvements
implemented over the last 5 years were
not considered
We believe that the EFSA reports do not
alter the quality and validity of the existing
risk assessments and the underlying data of
our products.
The Restrictions in EU 2013
January
EFSA 1 published
their reports for
IMI, CTD and
TMX2 (only for ST
+ granules!) and
noted there were
risks/data gaps
for their use in
bee-attractive
crops . EFSA
admitted large
areas of
uncertainty
February
March
European
Commission
presents a draft
(also incl. spray
applications) to
suspend all
applications of
these three CNI's
in bee-attractive
crops and cereals
for 2 years.
The Standing
Committee of the
Commission
voted on the
proposal by the
EU Member
States
representatives
and returned no
qualified majority
April
Even in a meeting
of the Conciliation
Committee, this
proposal also
returned a “no
qualified majority”
vote by the
representatives of
the EU Member
States.
May
According to EU law, the Commission can
now use its discretion to make its own
decision. It decided to ban Imidacloprid,
Clothianidin and Thiamethoxam in all
crops deemed attractive to bees
(including oilseed rape, corn and
sunflower) and spring cereals, from 30th
September 2013 – without time
limitation. Exceptions include applications
in greenhouses.
Furthermore, use by "non-professional
uses“, e.g. for amateur gardeners in the
house, will be forbidden.
(Thiacloprid is not affected)
1 European Food Safety Authority
2 Imidacloprid, Clothianidin (both Bayer) and Thiamethoxam (Syngenta)
The Restrictions in EU 2013
“The recent suspension of certain uses of neonicotinoid insecticides was not
imposed because they are the main threat to bee health but because they
were the only factor that could be quickly regulated by the European
January
February
March
April
May
Commission.”
EFSA 1 published
The Standing
European
Even in a meeting
According to EU law, the Commission can
Commission
of the Conciliation
now use its discretion to make its own
their reports for
Committee of the
presents
a
draft
Committee,
this
decision.
It decided to ban Imidacloprid,
IMI, CTD and
Commission
2
(also incl. spray
proposal also
Clothianidin and Thiamethoxam in all
TMX (only for ST
voted on the
applications)
to
returned
a
“no
crops deemed attractive to bees
+ granules!) and
proposal by the
suspend
all
qualified
majority”
(including
oilseed rape, corn and
noted there were
EU Member
applications of
vote by the
sunflower) and spring cereals, from 30th
risks/data gaps
States
these Head
three CNI's
representatives
2013 – without time
Drtheir
Michael
Flüh,
of therepresentatives
Chemicals Unit
in the EUof HealthSeptember
and Consumers
for
use in
in bee-attractive
the EU Member
limitation. Exceptions
include applications
bee-attractive
and returnedCommission
no
Directorate-General
at the European
(EC). Agrow: Aprilin greenhouses.
29th, 2014
crops and cereals
States.
crops . EFSA
qualified majority
for 2 years.
Furthermore, use by "non-professional
admitted large
uses“, e.g. for amateur gardeners in the
areas of
house, will be forbidden.
uncertainty
(Thiacloprid is not affected)
“Pesticides are just one of several factors that are impacting bees. Others
such as changing climate, biodiversity, food availability, pests and diseases
cannot be tackled through a basic legal act.”
1 European Food Safety Authority
2 Imidacloprid, Clothianidin (both Bayer) and Thiamethoxam (Syngenta)
Bee Health Issues are Caused by Multiple
Factors
Number of answers
25
20
15
10
5
0
Main Causes of Colony Mortality
Reported by EU Beekeepers and
MS Reference Laboratories for
Bee Health
Source: Presentation «Risk management for bee health» of DG for Health and Consumers, EU Commission
Published by CHAUZAT et al. 2013 (PlosOne 8/11)
Bee Health Issues are Caused by Multiple
Factors
20
15
10
5
0
Main Causes of Colony Mortality
Reported by EU Beekeepers and
MS Reference Laboratories for
Bee Health
25
Number of answers
Number of answers
25
20
15
10
5
0
Source: Presentation «Risk management for bee health» of DG for Health and Consumers, EU Commission
Published by CHAUZAT et al. 2013 (PlosOne 8/11)
Evidence from Monitoring Projects
Example: The German Bee Monitoring
 Large-scale multi-stakeholder multifactorial monitoring project to
analyze parameters affecting bee health and to investigate factors
contributing to honeybee colony losses
 Project ongoing since 2004. More than 1200 bee hives from 120
apiaries distributed all over Germany are regularly assessed
 Findings:
No correlation between colony mortality and pesticide residues in
hives;
No correlation between colony mortality and exposure to
neonicotinoid-treated crops
Very few findings of imidacloprid and clothianidin in hive matrices at
very low levels
Only clear correlation found was with Varroa infestation

Similar projects have been conducted in France, Spain, Belgium, and
other countries; no correlation was found between colony
mortality and the exposure to neonicotinoid residues
Honeybee Colony Losses in Europe
Source: COLOSS
 Overall loss rate was 9% in winter 2013/14, the lowest since many years
 Losses in 2014/15 were ca. 18%
 Overall, there is no correlation between bee losses and agricultural intensity, nor is there
any clear spatial pattern seen that would suggest the involvement of pesticide exposure
or agriculture in general as a key factor
 In the last year in which the full range of neonicotinoid products was still available, losses
were particularly low, whereas high losses were recorded in the first year after the
restrictions
Impact to Agriculture per Country
On May 22nd COPA-COGECA (EU farmers & agricultural cooperatives) held a
seminar on the impact of the restrictions of neonicotinoids, some key conclusions:
• 38,000 ha not planted- farmers did not plant oilseed rape due to lack of pest control options
• Yield of oilseed rape in decreased by 60,000 ha or 10% primarily due to flea beetle
• Insecticide spraying increased 4x, causing concerns of pest resistance development
• 6% decline of oilseed rape growing area
• Cabbage flea beetle has increased, damage in the leaves is estimated at 10%
• Farmers are spraying a lot more pesticides, increase in pest resistance concerns
• Clear increase in corn rootworm as well as cabbage flea beetles and cabbage root flies
• Alternatives (foliar spray up to 4x) less effective and more expensive than seed treatment
• Losses in corn due to wireworms estimated to 44%
• Farmers’ association estimates losses may add up to 56 million €/yr in high pressure years
• Strongest impact of restriction to corn. ¼ of productions have been affected for cattle farmers
• Area of spring sown oilseed rape has decreased from 54,000 ha in 2013 to 6,000 in 2015
• On average increase of foliar treatments from 2 to 5.5 sprays in oilseed rape
Emergency Approvals in Europe

Emergency approvals have been
granted in Finland, Estonia,
Romania, Denmark, and UK (BCS
products).
Further emergency approvals have
been granted in Bulgaria and Serbia.

In other countries grower
associations have applied for further
emergency authorizations

A new registration was granted in
France for seed treatment in cereals.
Situation in Other Countries
So far, the restrictions of the use of neonicotinoids as prescribed in Europe are
only implemented in the countries of the European Union (plus Switzerland,
Norway, and Serbia). No other country in the world has followed this example.
Paradigms from other countries:
United States:
National Strategy to Promote the Health of Honey Bees and other Pollinators
(June 2015): Focus on reduction of overwintering colony losses, pollination habitats,
education and outreach, foliar applications of pesticides. Risk-benefit analysis of
neonicotinoids in the context of regular regulatory process
Australia:
Re-evaluation of neonicotinoids by APVMA in 2014:
“The introduction of the neonicotinoid insecticides has brought a number of
benefits, including that they are considerably less toxic to humans than the […]
insecticides they have significantly replaced […]”; “The APVMA is currently of the view
that the introduction of the neonicotinoids has led to an overall reduction in the
risks to the agricultural environment from the application of insecticides.”
The benefits of Poncho Votivo far outweigh
any risks
1. We firmly believe that innovative products like Poncho Votivo will
help New Zealand farmers remain competitive;
2. Risks are well-managed under HSNO controls & industry codes;
3. The benefits of Poncho Votivo far outweigh any risks;
4. Poncho Votivo is precisely targeted at pests that attack plants
and spares beneficials;
5. It has a high level of safety for operators, unlike the alternatives
that it replaced;
6. Poncho has been safely used in New Zealand for 12 years, and
in that time, bee numbers have dramatically increased;
7. We request that the Authority approves Poncho Votivo.
Thank you!
Forward-Looking Statements
This presentation may contain forward-looking statements based on current
assumptions and forecasts made by Bayer Group or subgroup management.
Various known and unknown risks, uncertainties and other factors could lead to
material differences between the actual future results, financial situation,
development or performance of the company and the estimates given here.
These factors include those discussed in Bayer’s public reports which are
available on the Bayer website at www.bayer.com.
The company assumes no liability whatsoever to update these forward-looking
statements or to conform them to future events or developments.