# Pr oposed Decision Fr amew ork f or Assessing Risk s of P es ticides to Honey Bees **1** U.S. Environmental Pr otection Agency



# Ke ith Sapping ton, M.S. Environmental F ate and E ff ects Division Office of P es ticide Pr ogr ams

# Outline

**1.** 

# At **tribut es of Pr**  **oposed Process** 
**2.** 

# Process **fo r Foliar**  **Spr ay**  **Applications** U.S. Environmental Pr otection Agency 

### 2**A s** **N e** **e d** **e d** **: G** **e t** **D a** **t a** **, I** **t e** **r a** **t e** **, M** **o n** **i t** **o r**  **Integrate A** 

**vailable Inf**  **or mation**  **So urc**  **e &**  **Ecosy stem**  **E co**  **logic al**  **Exp os**  **ure at R**  **is k**  **Effects** 

# Problem **For mu**  **la tion** 



# Applications
**3.** 

# Process **fo r Soil/Seed**  **Tr ea**  **tmen t Applications** 
**4.** 

# Comparison **with other published risk**  **assessmen t schemes**  **Planning A** **s N** **e e** **d e** **d :** **G e** **t D** **a t** **a ,** **I t** **e r** **a t** **e ,** **M o** **n i** **t o** **r Assessmen**  **t En**  **dpoi nt**  **s**
**An al**  **ys is** 

**Pl an**  **Conc ep**  **tual**

**Mode l** 



# An **al ysi**  **s**U.S. Environmental Pr otection Agency 

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# At tribut es of Pr oposed Decision Fr amew ork
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# Three risk assessmen **t ‘tier**  **s’**

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# Tier 1 = scr eening lev el assessment (conserv at iv e, quan titative, individual

- level eff ects)

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# Tier s 2 and 3 = incr easing inf ormation needs (gr eater re alism, refined es timates of e xposur e, risk char act eriz ed a t colon y level) 

# Re **lies largely on guideline studies (and recommends sever**  **al**  

# in developmen **t)**  

# Fo **cuses on major**  **(and quan tifiable)**  **ex posur**  **e pathwa ys of**  **concern**  

# Separ **ate process f**  **or f oliar vs. soil/**  **seed tr ea**  **tmen t**  **applications**  

# Decisions **consider multiple lines of evidence and uncert ain**  **ty**U.S. Environmental Pr otection Agency 

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# Applic at ion of Pr oposed Decision Fr amew ork s
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# New **vs. e xisting pesticides** 

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# It **er ative nature of assessmen**  **ts**

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# Fr **amework fle**  **xibility**

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# Future modificationsU.S. Environmental Pr otection Agency **5** 1. Details of the product and its use pattern 2b. Is exposure of bee brood a concern? 2a. Is exposure of adult bees a concern?
3a. Calculate Tier 1 screening

- level EEC for **adult contact exposure** Contact Exposure 3b. Calculate Tier 1 screening

- level EEC for

**adult oral exposure** via pollen and nectar

Oral Exposure 3c. Calculate Tier 1 screening

- level EEC for **larval oral exposure** via brood food Oral Exposure

4a. Calculate Tier 1 screening

- level RQs for adult contact exposure **(RQ = EEC/adult acute contact LD**  **50 )**  4b. Calculate Tier 1 screening

- level RQs for adult oral exposure **(RQ = EEC/adult acute oral LD 50**  **& RQ = EEC/adult chronic NOAEC**  )* 4c. Calculate Tier 1 screening

- level RQs for larval oral exposure **(RQ = EEC/larval acute LD 50**  **& RQ= EEC/larval chronic NOAEC)** * No Tier 1 brood assessment

6. **Refine Tier 1 Exposure Assessment** (e.g., using available crop residue studies), Recalculate RQs. Presumption of minimal risk

Presumption of minimal risk 5 a,b,c. Does any RQ exceed LOC? 

# Risk **Assessment Scheme**  **fo r Foliar**  **Spr ay**  **A pplica**  **tion Tier 1** 

Y N 8. Consider Risk Mitigation Options, Uncertainties, Other lines of Evidence; Is a higher tier assessment needed? 9a. Conduct Tier 2 Exposure Studies (e..g, residues in pollen, nectar) 9b. Conduct Tier 2 Colony

Level Effect Studies (e..g, semi

- field, feeding) 10. Evaluate Tier 2 exposure and colony

- level effect results. Consider uncertainties and other lines of evidence. Do results indicate risk? 11. Consider Risk Mitigation Options, Uncertainties, Other Lines of Evidence; Is a higher Tier assessment needed? 12. Conduct Tier 3 Field Studies to address uncertainties 13. Evaluate Tier 3 field study results. Consider risk mitigation options, uncertainties and other lines of evidence. Do results indicate risk? 7 a,b,c. Does any RQ exceed LOC?

Presumption of minimal risk

Optional Presumption of risk * When tests are sufficiently developed and vetted **Tier 2**

**Tier 3**U.S. Environmental Pr otection Agency **6**

2b. Is exposure of bee brood a concern? * 2a. Is exposure of adult bees a concern? * 1. Details of the product and its use pattern

5 a,b. Does any RQ exceed LOC?
6. **Refine Tier 1 Exposure Assessment** (e.g., using available crop residue studies), Recalculate RQs. Presumption of minimal risk* 3a. Calculate Tier 1 screening

- level EEC for **adult oral exposure** via pollen and nectar

Oral Exposure 3b. Calculate Tier 1 screening

- level EEC for **larval oral exposure** via processed brood food

Oral Exposure

4a. Calculate Tier 1 screening

- level RQs for adult oral exposure **(RQ = EEC/adult acute oral LD 50**  **& RQ =EEC/chronic adult NOAEC)** ** 4b. Calculate Tier 1 screening

- level RQs for larval oral exposure **(RQ = EEC/larval acute LD 50**  **& RQ= EEC/chronic larval NOAEC)** ** No Tier 1 brood assessment Presumption of minimal risk 

# Risk **Assessment Scheme**  **fo r Soil/**  **Seed Tr**  **ea tment**  **Applica tion** 

Y N Optional *Mitigation of risks from abraded seed coatings is addressed outside of this process ** When tests are sufficiently developed 8. Consider Risk Mitigation Options, Other Lines of Evidence and Uncertainties; Is a higher tier assessment needed? 10. Evaluate Tier 2 exposure and colony

- level effect results. Consider uncertainties and other lines of evidence. Do results indicate risk? 9a. Conduct Tier 2 Exposure Studies (e..g, residues in pollen, nectar) 9b. Conduct Tier 2 Colony

Level Effect Studies (e..g, semi

- field, feeding)

11. Consider Risk Mitigation Options, Other Lines of Evidence and Uncertainties; Is a higher tier

assessment needed? Presumption of minimal risk 13. Evaluate Tier 3 field study results. Consider risk mitigation options, uncertainties and other lines of evidence. Do results indicate risk? 12. Conduct Tier 3 Field Studies to address uncertainties 7 a,b,c. Does any RQ exceed LOC?

Presumption of risk

# Comparison to Other Risk Assessmen t Schemes

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# Eur opean Food Saf ety Authority (EFSA 2012)

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# Society of En vir onmental T ox icology and Chemis try “P ells ton” W orkshop (Fischer and Moriarty 2011)

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# Some Similarities:

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## All in volved tiered processes (eff ects at the individual level, then at the colon y level) U.S. Environmental Pr otection Agency 

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## All in volved tiered processes (eff ects at the individual level, then at the colon y level)

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## Diff erent schemes depending on application method (f oliar spr ay , soil, seed treatment)

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## Contact and or al are dominant routes of exposur e

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## All recogniz e need fo r acute and chronic eff ects to be assessed initially

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# Some Diff **er ences:** 

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## Decision “triggers” tak e v arious fo rms (when specified)

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## Non
- Apis bees are included in EF SA (2012) and Fischer and Moriarty (2011), although full implementation will requir e additional research and test development.

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## Risk conclusions at higher tiers consider multiple lines of evidence, (White P aper); other schemes rely on outcome of semi field or field studies