Application for approval of Poncho Votivo Tonde Kaitano (Regulatory - - PowerPoint PPT Presentation

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

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

Authority Evaluation

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

• ccurs in NZ soils

Public submissions Hearing

3 December 2015

We welcome the

• pportunity 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

• f 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

• rganisms like bees via

generated dust? Bee exposure via pollen? Exposure of non-target

• rganisms 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

• f 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 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

Hives Beekeepers and Apiaries

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

• utstanding 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 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 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 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

• n 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

• ur 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

• f 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

• f 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

5 10 15 20 25 Number of answers

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

5 10 15 20 25 Number of answers

Source: Presentation «Risk management for bee health» of DG for Health and Consumers, EU Commission Published by CHAUZAT et al. 2013 (PlosOne 8/11)

5 10 15 20 25 Number of answers

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
• ther 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

• r 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

• nly 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.