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... Actual 100% Major crops analyzed: losses rice, wheat, barley, corn, Due to potatoes, soybeans, cotton, coffee pests, Today weeds 42% Prevented and 58% diseases losses By pests, weeds and 28% 30% diseases Yield without Actual yield with Theoretically crop protection crop protection 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; 12.2 t/ha (Scottish Farmer, 1989)  13.8 t/ha, Warren Darling, 2. Timaru, 2015

We thoroughly study & test our products before registration Submission ~NZ$ 500m Authority Evaluation Synthesis Process development Active ingredient Chemistry Synthesis optimisation Pilot plant production Formulation / Packaging Formulation Laboratory / Greenhouse Research Biology Profiling & positioning trials Efficacy trials for Registration Development Acute, sub-chronic, chronic toxicity Mammals mutagenicity, carcinogenicity, teratogenicity, reproduction 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 1 2 3 4 5 6 7 8 9 Leads >>50,000 500 Launch 2 1 10 3

Background on the Application - 98 g/L CTD Poncho Votivo (508 Application Poncho g/l CTD + 7.24x10 10 submitted 2014 (CTD 600 g/l) CFU/l BFi) CTD = clothianidin, Crops: maize, sweetcorn, + BFi a neonicotinoid cereals, forage brassicas 7.24x10 10 CFU/L first registered in & grass seed Variation: focus on maize NZ 06/06/2003 BFi = Bacillus firmus; naturally and sweetcorn only occurs in NZ soils Overseas Approvals – CTD: Public  Australia; submissions  North America;  EU (with restrictions);  Japan, RSA, etc. Hearing Consideration 3 December 2015 and decision Overseas Approvals – BFi: We welcome the  North America; opportunity to address  EU, RSA etc 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 Letter form Foundation For Arable Research underscores importance Plant-parasitic nematodes Greasy cutworm of controlling these pests

Clothianidin protects the seed & young plant 3 CONTROL OF FOLIAR PESTS 2 CONTROL OF SOIL PESTS 1 CONTACT EFFECT AGAINST SOIL PESTS

Bacillus firmus boosts overall plant health Nematodes Root Bacterial film Maize plant Bacteria Plant sugars Bacterial enzymes Nematode eggs Bacterial phytohormones

Are there risks with Poncho Votivo? Operator and Exposure of non-target bystander exposure? organisms like bees via generated dust? Bee exposure via Exposure of non-target pollen? 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 Varroa mite CTD seed treatments discovered 2000 safely used in NZ since 2003 Feral honey bees wiped out Managed hives increased by 80% as of Feb 2015 Honey bees also thriving in Australia, despite neonics use

Beehive numbers increasing in NZ NZ Totals – Number of Registered Beekeepers, Apiaries and Beehives 2000-2015 80,000 Beekeepers Apiaries Hives 550,000 70,000 500,000 60,000 Beekeepers and Apiaries Hives 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 2006 2007 2008 2009(J)* 2010(J) 2011(J) 2012(J) 2013 (F)2014 (F)2015 (F) 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

Poncho Votivo has a high level of safety for people and the environment Dust-off risk negligible – Low mammalian film coating and fluency toxicity agents Field studies: pollen Traces of clothianidin in exposure negligible 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 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.

Benefits: Clothianidin is applied at much lower rates, unlike the alternatives Seed treatment with Foliar treatment In-furrow treatment clothianidin with chlorpyrifos with phorate granules 2,000 300 90

Benefits: Poncho Votivo may eliminate several foliar applications Treatment of CTD active ~ 6 weeks whole area Yield up to 48% > untreated Foliar spray eliminated

Benefits: Operator & Environmental Safety Example Product & Application type HSNO classification Active Class Max. a.i. rate Approval No. ingredient g/ha Poncho Votivo Seed treatment 6.1D, 6.3B, 6.4A, 6.5B, 6.9B, 508 g/L CTD, Biologic + 90 CTD, 9.1A, 9.2B, 9.3B, 9.4A 102 g/L BFI neonic 1.3 x 10 10 cfu BFI Furakote EW Seed treatment 6.1B , 6.3B, 6.4A, 6.5B, 6.9A , 400 g/L Carbamate 300 HSR000943 9.2B, 9.3A , 9.4A furathiocarb Counter 20G HSR000216 Soil application 6.1A , 6.8B , 6.9A , 8.2C, 8.3A, 200 g/kg OP 1,500 9.1A, 9.3A , 9.4C terbufos Phorate 20 G Band application 6.1A, 6.8B, 6.9A , 9.2B, 9.3A , 200 g/kg phorate OP 2,000 HSR000210 at sowing 9.4B Grub Buster Diazinon Foliar (boom & 3.1D , 6.1D, 6.3B, 6.4A, 6.8B , 800 g/L diazinon OP 2,400 HSR100878 aerial) 6.9A , 9.1A, 9.2D, 9.3A , 9.4A Chlorpyrifos 500EC Foliar (boom & 3.1D, 6.1C, 6.3B, 6.4A, 6.8B, 500 g/L OP 625 HSR000224 aerial) 6.9A , 9.1A, 9.2B, 9.3A , 9.4A chlorpyrifos Metafort 60SL Foliar (boom & 3.1D, 6.1B, 8.2C, 8.3A, 6.9A, 600 g/L OP 600 HSR000226 aerial) 9.1A, 9.2B, 9.3A, 9.4A methamidophos Dominex 100 Foliar spray 3.1D , 6.1D, 6.3B, 6.9B, 9.1A, 100 g/L α - SP 20 HSR000293 9.3B, 9.4A cypermethrin AGPRO Lambda Foliar spray 6.1B, 6.3B, 6.4A, 6.9A, 9.1A, 250 g/L  - SP 10 cyhalothrin HSR100578 9.3B, 9.4A cyhalothrin X 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