EPA- PMRA- CDPR-Syngenta Meeting

February 13, 2013 

# Thiamethoxam **and Bee Health**2 

## EPA**- PMRA** **- CDPR** **- Syngenta**  **Meeting on Bee Health** ● Syngenta recognizes the important role that pollinators play in agriculture and the serious challenges facing the global health of honey bees 

## ● We wish to provide an update on the completed, current and planned research regarding the safety of thiamethoxam (TMX) to honey bees 

## ● We would like to gain a better understanding on the future regulatory landscape and data requirements in support of a science- based regulatory process3 

## Meeting Agenda 

## ● Introduction 

## ● SAP White Paper and Impact on Thiamethoxam Data Generation

- Toxicological data

- Residue data (pollen, nectar, other)

- Future p lans in response to SAP White Paper 

## ● Thiamethoxam Re-evaluation/Registration Review Discussion

- Impact on current Conditions of Registrations, timelines, next steps 

## ● Sustainability and Stewardship 

## ● Q&A and Discussion4 

## Current Data Requirements for Thiamethoxam **Canada:**

- Plant fate study for the seed treatment use pattern

- Plant fate study and a hive study for foliar and soil -applied products 

### USA:

- EPA :

- F ull field studies (including field residues) for seed treatment, foliar and soil uses



### - California :

- N ectar and pollen residue data in specific crops treated by soil or foliar application

- Toxicity study on honey bee larvae (completed) 

### Canada **and USA:**

- Data gaps identified by the registration review (EPA) and re-evaluation (PMRA) processes 

### ● It is our understanding that these Conditions of Registration should be addressed in a tiered approach as outlined in the SAP White Paper5 

## Global **Research on Thiamethoxam**  

## ● Completed research available to evaluate the short- and long -term effects of TMX to honey bees under laboratory and field conditions

- Acute and chronic toxicity data

- Residue levels in pollen and nectar tested from various crops

- Multi -year (4 year) hive health studies with seed treatment exposure (corn, oil seed rape); accepted for publication

- Rotational residue study in pollen and nectar following seed treatment/soil use

- Monitoring programs (e.g. FR)

# SAP White Paper and **Impact on Thiamethoxam**  **Data Generation**7 

## Toxicity**of Thiamethoxam to Honey B**  **ees Study** **/ Endpoint Va**  **lue (TMX)** Adult (oral) LD50 0.005 μg ai/bee Adult (contact) LD50 0.024 μg ai/bee Adult 10 -d chronic NOEC 32 μg ai/L (0.00898 μg ai/bee) Larval (oral) LC50 >1 13 μg ai/g diet8 

## Understanding Exposure to Thiamethoxam 

## ● Refinement of the Tier 1 exposure assessment through the use of pollen and nectar data from the treated crop (potential surrogate) 

## ● Various residue studies were conducted to meet regulatory needs in other jurisdictions 

## ● Future studies will involve crops selected based on the criteria below:

- Relevance to the agricultural landscape in North America

- Application rate

- Ability to surrogate to other crops or use patterns

- Attractiveness to honey bees

- Commercially pollinated

- Likelihood of exposure (e.g. timing of application relative to bloom)9 

## North American Uses **of Thiamethoxam**  **Bee attractive crops** : Crops that are commercially pollinated and/or documented to consistently attract honey bees when flowering due to the production of nectar and/or preferred pollen **Foliar**
• Cucurbit Ve getables • Fruiting Ve getables • Citrus • Berries • Cotton • Pome Fruit • Stone Fruit • Tropical Fruit • Tree Nuts • Mint • Legumes • Brassica Ve getables • Leafy V egetables • Root V egetables • Tu berous/Corm • Globe Artichoke • Grapes **Soil**
• Cucurbit Ve getables • Fruiting Ve getables • Citrus • Berries • Brassica Ve getables • Leafy V egetables • Root V egetables • Tu berous/Corm **Seed T reatment** 
• Cucurbit Ve getables • Cotton • Canola • Alfalfa • Sunflower • Brassica Ve getables • Leafy V egetables • Root V egetables • Legumes • Peanuts • Cereals • Corn • Rice10 

## Seed Treatment Uses **– North America**  **Attractive to Bees**  **(In Scope)** • Cucurbit V

egetables • Cotton • Canola • Sunflower **Not Attractive**  **(or Out of Scope)** • Brassica V

egetables • Leafy V

egetables • Root V egetables • Sugar Beets* • Legumes • Peanuts • Cereals • Corn • Rice • Alfalfa** * Sugar beets: harvested prior to flowering ** Alfalfa: exposure to bees is mitigated by requiring the treated crop to be cut prior to first bloom11 

## Residue Data **– Seed Treatment**  **Crop US/CDN** 

**Max Rate**  **mg ai** **/seed Study**  **Rate**

**mg ai** **/seed Pollen**  **Residue (ppb)**  **Nectar Residue (ppb)**  **Study**

**Status** TMX 322704 TMX 322704 Cotton 0.375 0.245 <1 <1 <1 <1 Complete 0.208 <1 <1 <1 <1 Sunflowera 0.25 0.264 <1 – 4.4 <1 <1 <1 Corn a 1.25 0.87 <1 – 12 <1 – 7 NA NA Soybeans b 0.1512 0.1512 1.06 - 21.4 b <1 - 4.82 b

--- 0.076 1.02 - 6.66 b <1 - 0.87 b Oilseed rape Not registered 419 – 451 g ai/100 kg c <1 – 4 d <1 – 1 <0.5 – 7 d <1 – 1 NA : Corn does not produce nectar a Multiple studies conducted; trial with maximum residue levels reported in the table b Reproductive structure analyzed as surrogate for nectar and pollen c Multiple studies d Samples collected from foraging bees12 

## Residue Data **– Carry** **- Over**  **to Flow ering**  **Crops from**

**Treated Seed Study**  **Study Rate**  **Pollen Residue (ppb)**  **Nectar Residue (ppb)**  TMX 322704 TMX 322704 Treated corn planted (Spring 2008) followed by treated barley (Fall 2008) followed by untreated alfalfa, OSR and Phacelia (2009) (collected from forager bees) Corn: 287 ai/100 kg (75 g ai/ha) Barley: 70 g ai/100 kg (72 g ai/ha) Alfalfa:

51 OSR: <1 – 1 Phacelia : <1 – 39 Alfalfa:

2 OSR: <1 – 3 Phacelia : <1 – 2 Alfalfa:

<0.5 – 0.6 OSR: <0.5 – 2.2 Phacelia : <0.5 Alfalfa:

<1 OSR: <1 Phacelia <1 – 113 

## Seed Treatment **– Residue Summary** 
● Current nectar and pollen residue data cover all bee relevant crops identified except for cucurbits 

## ● Syngenta believes that residue data from the major crops grown in North America supports the use of TMX as a seed treatment 

## ● What are the Agency’s position on the extrapolation of these data to support the use of TMX on cucurbit vegetables? **At tractiv** **e to Bees**  **(In Scope)**
• Cucurbit Ve getables • Cotton • Canola • Sunflower **Not At** **tractiv e**  **(or Out of Scope)**
• Brassica Ve getables • Leafy V egetables • Root V egetables • Sugar Beets* • Legumes • Peanuts • Cereals • Corn • Rice • Alfalfa** * Sugar beets: harvested prior to flowering ** Alfalfa: exposure to bees is mitigated by requiring the treated crop to be cut prior to first bloom14 

## Foliar Uses **– North America**  **Attractiv e**  **to Bees (In Scope)**  • Cucurbit V

egetables • Fruiting V

egetables • Citrus • Berries • Cotton • Pome Fruit • Stone Fruit • Tropical Fruit • Tree Nuts **Not Attractiv** **e (or Out of Scope)**  • Brassica V

egetables • Leafy V

egetables • Root V egetables • Tu berous/Corm • Legumes • Globe Artichoke • Grapes • Mint*

* Mint is typically harvested prior to bloom for optimal oil production15 

## Residue Data **– Foliar**  **Application Crop**  **Max Rate** 

**lbs ai** **/A (g**  **ai /ha)**  **Study Rate** 

**lbs ai** **/A (g**  **ai /ha)**  **Study**

**Ap plication**  **Ti ming**  **Pollen Residue** 

**(ppb) Nectar**  **Residue**

**(ppb) Study** 

**Status** TMX 322704 TMX 322704 Peach 0.172

(193.3) 0.056 x 1

(62.9 x 1 ) Pre- bloom

(6 days) <5 <5 <5 <5 Complete16 

## Residue Data **– Foliar (Continuously** **Flow ering**  **Crops) Crop**  **Study**

**/Max Rate**  **lbs ai** **/A (g**  **ai /ha)**  **Pollen Residue**

**(ppb) Nectar Residue**  **(ppb) Status**  TMX 322704 TMX 322704 Melon (Italy) 0.089 (100) 39 a <5 a <1 - 8 a <1 a Complete

- - 8 - 16 b <1 b a Application made 10 -d prior to bloom b Application made 5-d prior to bloom17 

## Foliar **– Residue**  **Summary**

- The use of peach (pre- bloom) and stone fruit (post- bloom) studies as a surrogate for citrus, pome, and tropical fruit

- The use of strawberry data as surrogate for other berry

crops (e.g. cranberries, blueberries, etc.)

- The use of almond data (if conducted) as surrogate for all tree nuts 

### ● Syngenta plans to conduct a residue study wi th a cucurbit vegetable to match the North American use pattern

- Can data from cucurbit vegetable study be used as surrogate for fruiting vegetables? **At tractive**  **to Bees (In Scope)**  • Cucurbit V

egetables • Fruiting V

egetables • Citrus • Berries • Cotton • Pome Fruit • Stone Fruit • Tropical Fruit • Tree Nuts **Not At** **tractiv e**  **(or Out of Scope)** • Brassica V

egetables • Leafy Vegetables • Root V egetables • Tu berous/Corm • Legumes • Globe Artichoke • Grapes • Mint* 

### ● Pollen and nectar residue data will be available for stone fruit, cotton, cucurbit vegetables, strawberries and potentially almonds 

### ● What are the Agency’ s positions on surrogating residue data among similar crops or use patterns? For example :18 

## Soil Uses **– North America**  **Attractiv e to Bees**  **(In Scope)** • Cucurbit Vegetables • Fruiting V

egetables • Citrus • Berries (e.g. strawberries) **Not Attractiv** **e (or Out of Scope)**  • Brassica Vegetables • Leafy V

egetables • Root V egetables • Tu berous/Corm19 

## Residue Data **– Soil**  **Application Crop**  **Max Rate** 

**lbs ai** **/A (g**  **ai /ha)**  **Study Rate** 

**lbs ai** **/A (g**  **ai /ha)**  **Pollen Residue**

**(ppb) Nectar Residue**  **(ppb) Study** 

**Status** TMX 322704 TMX 322704 Cucurbits (Cucumber) 0.172

(192) 0.172

(192) 1.29 - 8.22 0.23 - 2.58 1.26 - 11 .48 <1 - 1.75 Complete To mato a 0.172

(192) 0.172

(192) 2.2 - 45.7 a 13.2 - 80.2 a ---

a Wh ole flower analyzed as surrogate for nectar and pollen20 

## Soil **– Residue Summary**  

## ● Pollen and nectar data are available for cucurbit vegetables and will be available for citrus in 2013

- Can cucurbit vegetable data be used as surrogate for fruiting vegetables and strawberries?

**At tractive**  **to Bees (In Scope)**  • Cucurbit V

egetables • Fruiting V

egetables • Citrus • Berries **Not At** **tractive (or Out of Scope)**  • Brassica V

egetables • Leafy Vegetables • Root V egetables • Tu berous/Corm21 

## Risk **Assessment –**  **Soil Use ( Cucumber)**  ● Tier I – Use of measured residues **As sessment**  **Nectar Residue**  **(μg ai** **/L) Feeding**  **Rate**

**(mg food/bee)**  **Dose -** **based**

**EEC (μg**  **ai /bee)**  **To xicity** 

**Endpoint (μg**  **ai /bee)**  **RQ** Adult Acute TMX 10.58 a 292 0.0034 0.005 **0.62**

TMX+322704 12.55 a,b 292 0.0037 0.005 **0.73** Adult Chronic TMX 10.58 a 292 0.0034 0.00898 0.34

TMX+322704 12.55 a,b 292 0.0037 0.00898 0.41 Larval Acute TMX 10.58 a 120 0.0014 13.56 c <0.01

TMX+322704 12.55 a,b 120 0.0015 13.56 c <0.01 Acute LOC = 0.4; Chronic LOC = 1.0 a 95 th percentile value (n=9) b TMX + 322704 = TMX (ppb) + 322704 (ppb) x 1.165; 1.165 = TMX MW (291.02) / 322704 MW(249.8) c Conversion of LC50 (1 13 mg/kg) to a dose estimate per bee by multiply by the larval feeding rate (120 mg food/bee)22 

## Risk **Assessment –**  **Tier II Refinement** 

## ● Exceeding the acute LOC of 0.4 would trigger a Tier II study for further refinement of the risk assessment 

## ● If a semi -field study (tunnel study) is conducted with cucumber, can this study be used to support all soil uses? 

## ● If multiple crops are identified as needing Tier II studies to refine the risk assessment, can a hive feeding study be used to establish a hive- level NOEC that could be used to compare with pollen and nectar residues for all crops and uses?

# Thiamethoxam **Re -** **evaluation/ Re**  **- registration** 24 

## Q&A **– Open Discussion**  

## ● Will the current conditions of registration change to reflect the SAP White Paper process?

- Example: A hive health study has been required before the completion of tier 1 residue data 

## ● We understand the DCI will be issued by the end of February 2013. What are the other milestones for the EPA/PMRA joint thiamethoxam registration review / re-evaluation?

- How will the Agencies collaborate?

- When will Syngenta Canada receive the PMRA request for submitted, underway and planned studies ?25 

## Q&A **– Open Discussion**  

## ● Syngenta is committed to addressing the conditions of registration; however, higher tiered data may not be completed within the 24 month timeline outlined in the EPA work plan. What recommendations do the Agencies have based on the following timeline proposal:

- 2013 – 2014: Pollen and nectar residue

- 2013 – 2015: Tier II studies (as required)

- 2016 – 2017: Full field study (if triggered) 

## ● What regulatory implications do the Agencies see from the recent EFSA report?

# Sustainability**a nd**  **Stewardship**27 

## Syngenta **Activities Related to Pollinator Health**  ● Syngenta is actively promoting the link between pollinator health and sustainable agriculture 

## ● Increasing the awareness of bee health issues

- www.plightofthebees.com 

## ● Encouraging biodiversity at the farm level

- Operation Pollinator

- 3 rd year of academic research on the benefit (yield) to crops adjacent to pollinator habitats



### - Scoping additional opportunities wi th third parties

- Fondation de la Faune (trial project underway)

- Others28 

## Pollinator **Health Activities (cont’d)** ● Ongoing varroacide evaluation projects 

## ● Epidemiological review of bee health in Europe

- Lead: J. Cresswell , Exeter University (UK) 

## ● Bee health model in development that integrates internal hive factors (e.g. Varroa, disease) with external stressors (e.g. forage availability)

- In collaboration with: Rothamsted Research (J. Osborne, M. Belcher), Warwick Univ. (D. Chandler), Helmholtz UFZ (V. Grimm)

- Several publications in various stage of preparation (in review or draft)29 

## Stew**ardship –**  **Initial Focus on Seed Treatment**  

## ● Internal activities and collaborative projects underway:

- Seed treatment quality, formulation design and application technology

- Promotion of “best practices”

- Syngenta and CLC ST Certification Programs

- ASTA/CLA collaborations



### - Communication of Best Management Practices (e.g. CLC/CLA, ASTA, GFO, grower meetings, etc.)

- Corn Dust Research Consortium through Pollinator Partnerships

- A multi -stakeholder initiative to investigate ways to reduce honey bee exposure to dust during planting of treated corn seeds30