# Link To Webinar Recording: Preliminary Imidacloprid Pollinator Risk Assessment Technical Briefing Webinar Recording

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# Public Webinar on Imidacloprid Preliminary Pollinator Assessment

Office of Pesticide Programs / Environmental Protection Agency February 18th, 2016 2

### • Process
• Assessment details and findings
• Next steps
• Q & A session

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# Presentation Outline

### • Imidacloprid is one of the neonicotinoid insecticides currently undergoing Registration Review
• This assessment (released January 2016):  Follows Problem Formulation and Preliminary Work Plan (2008) and Data Call - In (2010)  Fulfills an EPA commitment to Presidential Pollinator Strategy • Pollinator Health Task Force (May 2015) 

###  Is located in the public docket available at: http://www.regulations.gov/#!docketDetail;D=EPA- HQ- OPP 2008-0844

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# Process

# Typical Registration Review Process

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# Public Comment Opportunities

Open D ocket Preliminary Risk Assessment Revised Risk Assessment And Proposed Decision Final Decision

# Imidacloprid Registration Review Process

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# Public Comment Opportunities

Open D ocket Preliminary Pollinatoronly Risk Assessment Preliminary Ecological and Human Health Risk Assessment Final Decision Proposed Decision

# Risk Management

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## Regulatory Decision Benefits Analysis Risk Assessment and Characterization Risk Management Options Legal Standards Public Input

### • Nitroguanidine - substituted neonicotinoid insecticide • Mobile  Highly soluble  High tendency to runoff 

### • Systemic • Mode of action:

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# Background

Receptor Imidacloprid Overstimulation / blockage of receptor Paralysis / death9 

## Multiple Factors Affecting Honey Bee Health

Urbanization Agricultural Practices

Pesticides Bee Management Practices 

### Nutrition Honey bee losses: Research has identified multiple factors; no single factor identified as “cause”. Disease/Parasites

# Scope of Assessment • Follows bee risk assessment framework published in 2014  Developed by the Environmental Protection Agency (EPA), California Department of Pesticide Regulation (CDPR), and Canada’s Pest Management Regulatory Agency (PMRA)  Received independent, peer review in 2012 

### For this assessment: • Honey bee (Apis ) focus • Agricultural uses only Follow- on assessment planned for December 2016: • All other wildlife • Non - agricultural uses • Additional residue data 10

### • Methods of application:  Direct sprays on crop  Soil  Seed treatment 

### • Registered u ses on variety of crops (including but not limited to):  Vegetables (tomatoes, legumes, broccoli, lettuce)  Fruits (apples, citrus, berries)  Cereal grains (corn, wheat, sorghum)  Tree nuts (walnuts, pecans)  Other (cotton)
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# Agricultural Uses of Imidacloprid

# Exposure Routes Exposure routes assessed: • Contact exposure (direct spray applications only)  Adults only 

### • Oral exposure by ingestion of contaminated pollen and nectar (direct spray/soil/seed applications)  Adults  Larvae 

### Other routes being considered: • Guttation/surface water • Abraded dust from seed treatments 1213 

# Risk Assessment Process Determination of Potential Exposure 

### Tier I • Screening- level • Refined Tier II (Semi -field) • Tunnel • Feeding Tier III (Full -field)

# Toxicity Data

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## • Considers registrant- submitted AND open literature sources • Focus on survival, growth/development, and reproduction) • Registrant submitted:  Contract laboratory- conducted  GLP, Office of Chemical Safety and Pollution Prevention (OCSPP) guidance - compliant  Results and statistical analysis verified by EPA 

## • Open literature studies:  Evaluation of strengths and limitations  Supplanted registrant-submitted endpoints in some cases 

## • 100+ studies evaluated

# Individual Level Toxicity (Tier I) • Conducted in lab • Vary in exposure route, life stage tested, and duration • Data indicate  Adults more sensitive than larvae  Oral route more sensitive than direct contact

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# Colony Level Toxicity (Tier II)
• Conducted in field • Limited dataset in the open literature for evaluating colony level effects to Apis • Consultation with researchers and registrant to design a novel chronic colony feeding study (CFS) Registrant- submitted CFS: • Robust:  High replication (n=12 - 24 colonies/trt )  12.5, 25, 50, 100, and 200 ppb  Overwintering period  Pathogen and parasite monitoring • Spiked sucrose (nectar) for 6 weeks  Freely foraged for pollen  Exposure period consistent with bloom duration of some crops ( e.g. citrus fruits) • No Observed Adverse Effect Concentration (NOAEC) = 25 ppb; Lowest Observed Adverse Effect Concentration (LOAEC) = 50 ppb in nectar  ↓ in - hive pollen provisions, #s of pupae and adults17 

# CFS Results 12.5 ppb

25 ppb 50 ppb 100 ppb 200 ppb ↓ Adults, ↓ Eggs, ↓ Larvae, ↓ Pupae, ↓ Pollen, ↓ Honey > 80% colony mortality post- overwintering Response variables trended with control **Further information can be found in Section 5.2.1 of the assessment

# Risk Characterization

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# Considers Multiple Lines of Evidence: • Determination of exposure • Individual Level (Tier I) Risk Quotients (screening level, refined exposure) • Colony Level (Tier II) Assessment (nectar) • Colony Level (Tier III) Assessment • Incidents • Hive residue monitoring • Non -Apis bees

# Risk Characterization

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### • Determining Exposure:  Crop attractiveness  Agronomic practices

### • Individual Level (Tier I)  Screening- Level  “High end,” model -generated exposure estimates  Individual organism toxicity endpoints  Risk estimated for various life stages and durations of exposure 

###  Refined  Nectar/pollen data used for exposure  Individual organism toxicity endpoints  Risk estimated for various life stages and durations of exposure  Determination of duration of risk concerns 20 

# Risk Characterization

When residue data are available

### • Colony Level (Tier II) ( nectar )  Comparison of residues to colony level endpoint (25 ppb)  Nature of residues over time  Influence of soil type  Consideration of bloom duration

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# Risk Characterization

### • Colony Level (Tier III)  Available dataset not useful for effects characterization  Ongoing studies with cotton and pumpkin

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# Risk Characterization

### • Reported Incidents  Limited (6) reports for agricultural uses linked to imidacloprid exposure  Lack of reported incidents does not indicate lack of losses in the field 

### • Agricultural Monitoring Studies (seed treatment)  High frequency of detection, low mean residues in pollen (2 – 3 ppb) 

### • Hive Monitoring Studies (nectar, pollen, wax, bees):  Generally low frequency of detects 23 

# Risk Characterization

# Risk Characterization - Non - Apis
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### > 4,000 species of non -Apis bees in U.S. • 

### Differences in biology, ecology expected to lead to different exposures vs. Apis • 

### Relevant to pollinator protection goals (commercial pollination services, biodiversity)

Osmia lignaria – Blue orchard bee Megachile rotundata – Alfalfa leafcutter bee

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## Risk Characterization - Non - Apis
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### Tier I risk assessment methods and data currently lacking  

### Limited data suggest honey bee is protective of bumble bees and solitary species • 

### Open literature data suggest bumble bees may be sensitive at the colony level  

### Additional data would reduce this uncertainty

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# Honey Bee Risk Determinations – Foliar Applications

- Root/Tuber Vegetables

- Leafy Green Vegetables

- Brassica Vegetables

- Fruiting Vegetables

- Tobacco

- Globe artichoke

- Legumes

- Pome Fruits

- Stone Fruits

- Berries/Small Fruits

- Tree Nuts

- Herbs/Spices - Citrus Fruits

- Cotton

Low Uncertain Risk 26

# Honey Bee Risk Determinations – Soil Applications

- Root/Tuber Vegetables

- Bulb Vegetables

- Leafy Green Vegetables

- Brassica Vegetables

- Fruiting Vegetables

- Berries/Small Fruits

- Tobacco

- Globe artichoke
- Legumes

- Cucurbit Vegetables

- Citrus Fruits

- Pome Fruits

- Stone Fruits

- Berries/Small Fruits

- Tree Nuts

- Herbs/Spices - Cotton

Low Uncertain Risk 27

# Honey Bee Risk Determinations – Seed Applications

- Root/Tuber Vegetables

- Bulb Vegetables

- Brassica Vegetables

- Cereal Grains (corn) - Legumes

- Cereal Grains (nectar producers)

- Herbs/Spices

- Oilseed

Low Uncertain Risk 28

## Major Assumptions/Uncertainties in Risk Assessment • Colony (Tier II) level (Exposure):  Risk determinations assumes bees feed continuously on treated crop for 6 weeks  Representativeness of 6 week exposure per CFS  Long blooming crops (cotton, citrus, strawberry) vs. short blooming crops (cherry, blueberry) 

###  Migratory pollination services 

### • Limited full field colony level (Tier III) data:  Ongoing studies for cotton and pumpkin 

### • Forthcoming residue data:  Reduce uncertainty for several uses 29

### • Public comment period for 60 days (ends March 15, 2016) • Follow- on assessment:  Review public comments  Incorporation of additional bee data  Inclusion of non - agricultural uses  Assessment of other taxa ( e.g., fish, aquatic invertebrates, plants, birds, mammals) 

### • December 2016 – publish follow- on assessment  Preliminary pollinator assessments for clothianidin, thiamethoxam, and dinotefuran 

### • Consider appropriate risk management strategies:  Risk management discussions with stakeholders  Risk management options:  Consideration of risks and benefits  Likely alternatives  Potential impact on agricultural production and users 

# Next Steps1. USDA. 2015. Attractiveness of Agricultural Crops to pollinating Bees for the Collection of Nectar and/or Pollen. United States Department of Agriculture. http://www.ree.usda.gov/ree/news/Attractiveness_of_Agriculture_crops_to_ pollinating_bees_Report- FINAL.pdf 2. USEPA . 2012. White Paper in Support of the Proposed Risk Assessment Process for Bees. Submitted to the FIFRA Scientific Advisory Panel for Review and Comment September 11 – 14, 2012. http ://www.regulations.gov/#! documentDetail;D=EPA- HQ- OPP - 2012 -0543 - 0004 3. USEPA/PMRA/CDPR . 2014. Guidance for Assessing Pesticide Risks to Bees. Office of Pesticide Programs, United States Environmental Protection Agency, Washington, D.C.; Health Canada Pest Management Regulatory Agency Ottawa, ON, Canada California Department of Pesticide Regulation, Sacramento, CA. http ://www2.epa.gov/pollinator- protection/pollinator- risk- assessment-guidance 4. USEPA. 2016. Preliminary Pollinator Assessment to Support the Registration Review of Imidacloprid. Office of Chemical Safety and Pollution Prevention. United States Environmental Protection Agency. http://www.regulations.gov/#! documentDetail;D=EPA- HQ- OPP - 2008 -0844- 0140 31 

# References32 

# Q & A Session