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...

Source: Oerke et al., Crop Production and Crop Protection, Elsevier, Amsterdam, 1994

Yield without

crop protection

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

Actual

losses

30%

100%

Prevented

losses

Today

58%

By pests,

weeds and

diseases

Due to

pests,

weeds

and

diseases

28%

42%

Major crops analyzed:

rice, wheat, barley, corn,

potatoes, soybeans, cotton, coffee

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

0 2 3 4 5 6 7 8 1

Synthesis Process development

Formulation / Packaging

Pilot plant production Chemistry

Biology

Toxicology

Environment

Laboratory / Greenhouse

Profiling & positioning trials

Efficacy trials for Registration

Acute, sub-chronic, chronic toxicity

mutagenicity, carcinogenicity, teratogenicity, reproduction

Algae, daphnia, fish, birds, microorganisms,

bees, non-target organisms

Plants, animals, soil, water

Soil, water, plants, animals , air

Auth

ori

ty E

valu

ation

Year

Submission ~NZ$ 500m

9

Synthesis optimisation

Active ingredient

Formulation

Mammals

Ecosystems

Research

Development

Metabolism

Residues

Leads >>50,000 500 3 10 2 1 Launch

Background on the Application

Poncho (CTD 600 g/l)

CTD = clothianidin,

a neonicotinoid

first registered in

NZ 06/06/2003

+ BFi 7.24x1010 CFU/L

- 98 g/L CTD

Poncho Votivo (508

g/l CTD + 7.24x1010

CFU/l BFi)

Application

submitted 2014

BFi = Bacillus firmus; naturally

occurs in NZ soils

Public

submissions

Hearing 3 December 2015

We welcome the

opportunity to address

concerns raised by

submitters

Consideration

and decision

Overseas Approvals – CTD:

Australia;

North America;

EU (with restrictions);

Japan, RSA, etc.

Overseas Approvals – BFi:

North America;

EU, RSA etc

Variation: focus on maize

and sweetcorn only

Crops: maize, sweetcorn,

cereals, forage brassicas

& grass seed

Poncho Votivo is safely manufactured,

shipped and applied

AGCARM and NZGSTA

Stewardship Guides

Poncho Votivo controls critical pests

Argentine stem weevil (ASW) Black beetle

Plant-parasitic nematodes Greasy cutworm

Targets

Letter form Foundation

For Arable Research

underscores importance

of controlling these pests

1 2

3

CONTACT EFFECT

AGAINST SOIL PESTS

CONTROL OF

SOIL PESTS

CONTROL OF

FOLIAR PESTS

Clothianidin protects the seed & young plant

Bacillus firmus boosts overall plant health

Bacteria Plant sugars Bacterial enzymes

Nematode eggs Bacterial phytohormones

Maize plant

Bacterial film

Root Nematodes

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

Varroa mite

discovered 2000

Managed hives

increased by 80% as

of Feb 2015

Feral honey bees

wiped out

Honey bees also

thriving in Australia,

despite neonics use

Beehive numbers increasing in NZ

250,000

300,000

350,000

400,000

450,000

500,000

550,000

0

10,000

20,000

30,000

40,000

50,000

60,000

70,000

80,000

2000 2001 2002 2003 2004 2005 2006 2007 2008 2009(J)* 2010(J) 2011(J) 2012(J) 2013 (F)2014 (F)2015 (F)

NZ Totals – Number of Registered Beekeepers, Apiaries and Beehives 2000-2015

Beekeepers Apiaries Hives

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

Hiv

es

Be

eke

ep

ers

and

Ap

iaries

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

Overall, Poncho Votivo is safe for people and the environment when

used in accordance with label instructions

Controls under HSNO Act

and product stewardship

further reduce risk

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

B. firmus protects maize plants from

nematodes attack and boosts overall plant

health.

Nematodes

attack plant

roots:

Benefits: Maize is an important crop in

pastoral agriculture

1. Livestock & dairy = 60% of

NZ exports;

2. Maize yields high dry matter

in a short time period;

3. A high quality forage

supplement;

4. An important break crop in a

pasture renewal cycle

higher performing pastures;

5. Limits importation of palm

kernel.

Foliar treatment

with chlorpyrifos In-furrow treatment

with phorate granules

Seed treatment with

clothianidin

Benefits: Clothianidin is applied at much

lower rates, unlike the alternatives

90 2,000 300

Benefits: Poncho Votivo may eliminate

several foliar applications

Treatment of

whole area CTD active ~ 6 weeks

Yield up to

48% >

untreated

Foliar spray eliminated

Benefits: Operator & Environmental Safety

Alternatives are more toxic, have limited spectrum and effectiveness,

and may require up to 6 weeks fallow X

Example Product & Approval No.

Application type HSNO classification Active ingredient

Class Max. a.i. rate g/ha

Apps / season

Poncho Votivo Seed treatment 6.1D, 6.3B, 6.4A, 6.5B, 6.9B, 9.1A, 9.2B, 9.3B, 9.4A

508 g/L CTD, 102 g/L BFI

Biologic + neonic

90 CTD, 1.3 x 1010 cfu BFI

1

Furakote EW HSR000943

Seed treatment 6.1B, 6.3B, 6.4A, 6.5B, 6.9A, 9.2B, 9.3A, 9.4A

400 g/L furathiocarb

Carbamate 300 1

Counter 20G HSR000216 Soil application 6.1A, 6.8B, 6.9A, 8.2C, 8.3A, 9.1A, 9.3A, 9.4C

200 g/kg terbufos

OP 1,500 *

Phorate 20 G HSR000210

Band application at sowing

6.1A, 6.8B, 6.9A, 9.2B, 9.3A, 9.4B

200 g/kg phorate OP 2,000 *

Grub Buster Diazinon HSR100878

Foliar (boom & aerial)

3.1D, 6.1D, 6.3B, 6.4A, 6.8B, 6.9A, 9.1A, 9.2D, 9.3A, 9.4A

800 g/L diazinon OP 2,400 **

Chlorpyrifos 500EC HSR000224

Foliar (boom & aerial)

3.1D, 6.1C, 6.3B, 6.4A, 6.8B, 6.9A, 9.1A, 9.2B, 9.3A, 9.4A

500 g/L chlorpyrifos

OP 625 **

Metafort 60SL HSR000226

Foliar (boom & aerial)

3.1D, 6.1B, 8.2C, 8.3A, 6.9A, 9.1A, 9.2B, 9.3A, 9.4A

600 g/L methamidophos

OP 600 **

Dominex 100 HSR000293

Foliar spray 3.1D, 6.1D, 6.3B, 6.9B, 9.1A, 9.3B, 9.4A

100 g/L α-cypermethrin

SP 20 **

AGPRO Lambda cyhalothrin HSR100578

Foliar spray 6.1B, 6.3B, 6.4A, 6.9A, 9.1A, 9.3B, 9.4A

250 g/L -cyhalothrin

SP 10 **

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 seed-treated crops does not constitute a significant risk to bee colonies

The Restriction in EU - EFSA reports 2013

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.

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

Key facts on the EFSA reports

1 Imidacloprid, Clothianidin (both BCS) and Thiamethoxam (Syngenta)

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

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.

March

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

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

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.

March

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 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

Commission.”

“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.”

Dr Michael Flüh, Head of the Chemicals Unit in the EU Health and Consumers

Directorate-General at the European Commission (EC). Agrow: April 29th, 2014

Bee Health Issues are Caused by Multiple

Factors

0

5

10

15

20

25

Nu

mb

er

of

answ

ers

Source: Presentation «Risk management for bee health» of DG for Health and Consumers, EU Commission

Published by CHAUZAT et al. 2013 (PlosOne 8/11)

Main Causes of Colony Mortality

Reported by EU Beekeepers and

MS Reference Laboratories for

Bee Health

Bee Health Issues are Caused by Multiple

Factors

0

5

10

15

20

25

Nu

mb

er

of

answ

ers

Source: Presentation «Risk management for bee health» of DG for Health and Consumers, EU Commission

Published by CHAUZAT et al. 2013 (PlosOne 8/11)

0

5

10

15

20

25

Nu

mb

er

of

answ

ers

Main Causes of Colony Mortality

Reported by EU Beekeepers and

MS Reference Laboratories for

Bee Health

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.