1

FIFRA SCIENTIFIC ADVISORY PANEL (SAP)

OPEN MEETING

September 11 – 14, 2012

FIFRA SAP WEB SITE http://www.epa.gov/scipoly/sap/

OPP Docket Telephone: (703) 305-5805

Docket Number: EPA-HQ-OPP-2012-0543

U.S. Environmental Protection Agency

Potomac Yard One South

2777 Crystal Drive

Arlington, VA 22202

Pollinator Risk Assessment Framework 

Please note that all times are approximate

(See note at the end of the Agenda)

Tuesday, September 11, 2012

9:00 A.M. Opening of Meeting and Administrative Procedures – Fred Jenkins, Ph.D., 

Designated Federal Official, Office of Science Coordination and Policy, EPA

9:05 A.M. Introduction and Identification of Panel Members FIFRA Scientific Advisory

Panel Chair, – Daniel Schlenk, Ph.D.

9:15 A.M. Welcome and Opening Remarks – Steven Bradbury, Ph.D., Office of Pesticide 

Programs (OPP), EPA

9:20 A.M. Goals and Objectives – Donald Brady, Ph.D., Environmental Fate and Effects 

Division (EFED), OPP, EPA

9:35 A.M. Pesticide Management Regulatory Agency (PMRA) Collaboration – Mary

Mitchell, PMRA, Health Canada

9:45 A.M California Department of Pesticide Regulation Collaboration – Richard 

Bireley, California Department of Pesticide Regulation, California Environmental 

Protection Agency

9:55 A.M. Introduction, Background and Status – Thomas Moriarty, M.S., Pesticide 

Reevaluation Division, OPP, EPA
2

10:30 A.M Break

10:45 A.M. Conceptual Models and the Proposed Risk Assessment Process – Keith 

Sappington, M.S., EFED, OPP EPA

11:30 A.M. Exposure Pathways of Pesticides to Honey Bees and their Relative 

Importance – Christina Wendell, M.S., EFED, OPP, EPA

11:45 P.M. Lunch

12:45 P.M. Tier I Method for Estimating Exposure of Honey Bees to Pesticides – Kristina 

Garber, M.S., EFED, OPP, EPA

2:00 P.M. Tier I Exposure Refinements & Tier II Tools for Assessing Exposure of Bees 

to Pesticides – Reuben Baris, M.S., EFED, OPP, EPA

2:30 P.M. Break

2:45 P.M. Methods for Evaluating Toxicity of Pesticides on Bees – Joseph Decant, M.S., 

EFED, OPP, EPA

4:00 P.M. Risk Characterization – Thomas Steeger, Ph.D., EFED, OPP, EPA

4:15 P.M. Tier I Screening Process Performance – Reuben Baris, M.S., EFED, OPP, EPA

4:30 P.M. Colony-level Simulation Models – Keith Sappington, M.S., EFED, OPP, EPA

5:00 P.M. Adjournment
3

AGENDA

FIFRA SCIENTIFIC ADVISORY PANEL (SAP)

OPEN MEETING

September 11 – 14, 2012

FIFRA SAP WEB SITE http://www.epa.gov/scipoly/sap/

OPP Docket Telephone: (703) 305-5805

Docket Number: EPA-HQ-OPP-2012-0543

Potomac Yard One South

2777 Crystal Drive

Arlington, VA 22202

Pollinator Risk Assessment 

Wednesday, September 12, 2012

9:00 A.M. Opening of Meeting and Administrative Procedures – Fred Jenkins, Ph.D., 

Designated Federal Official, Office of Science Coordination and Policy, EPA

9:05 A.M. Introduction and Identification of Panel Members – FIFRA Scientific 

Advisory Pane Chair, Daniel Schlenk, Ph.D.

9:10 A.M. Follow-up From Previous Day’s Meeting – Daniel Schlenk, Ph.D., FIFRA SAP 

Chair

9:20A.M. Public Comments

10:30 A.M. Break

10:45 A.M. Public Comments Continued 

11:45 A.M. Lunch
4

12:45 P.M. Charge Question 1 

Section 2.2.1 of the white paper discusses the protection goals and associated assessment 

endpoints for assessing risks to honey bees (Apis mellifera). The protection goals are:

 protection of pollination services;

 protection of honey and hive product production; and,

 protection of pollinator biodiversity.

As described in the white paper, assessment endpoints are based on their ecological 

relevance, their susceptibility to known or potential stressors and their relevance to 

protection goals. 

a. Please comment on whether the assessment endpoints (e.g., population size and 

stability of managed bees, quantity and quality of hive products, and species 

richness and abundance) identified in Table 1 in Section 2.2.1 of the white paper 

are consistent with the Agency’s protection goals. Please include a discussion of 

any additional assessment endpoints that may be necessary to meet those 

protection goals

b. Please comment on whether the measurement endpoints at the level of the colony

(e.g., colony strength and survival, contamination of pollen and nectar and species 

richness and abundance) identified in Table 1 are consistent with the assessment 

endpoints identified in the table and any additional assessment endpoints 

discussed in Part “a” of this question. Please include a discussion of any 

additional measurement endpoints that may be necessary to represent those 

assessment endpoints.

c. Please comment on whether the measurement endpoints at the level of the 

individual bee (e.g., individual adult and larval [brood] survival, queen fecundity, 

brood emergence success, worker longevity) identified in Table 1 are consistent 

with assessment endpoints identified in the table and any additional assessment 

endpoints discussed in Part “a” of this question. Please include a discussion of any 

additional measurement endpoints that may be necessary to represent those 

assessment endpoints.

1:45 P.M. Charge Question 2

Section 2.2 of the white paper discusses a series of conceptual models for assessing risks 

of honey bees resulting from pesticide applications. These models depict the nature of 

the stressor (i.e., nonsystemic and systemic pesticides that are applied as foliar 

treatments, soil and/or seed treatments, or trunk injection), its source (e.g., direct 

deposition on bees or pollen), the exposure media (e.g., residues on plants, residues in/on 

pollen/nectar), receptors (e.g., foraging bees, developing brood) and attribute changes 

(e.g., reduced [bee] population, reductions in the quantity/quality of honey). 

a. Please comment on whether the conceptual models depicted in Figures 4 through 

8 are consistent with the protection goals and assessment endpoints identified in 

Table 1 and discussed in Question 1.

.
5

2:45 P.M. Break

3:00 P.M. Charge Question 3 

The focus of the white paper and proposed risk assessment process on the honey bee 

reflects two important factors: 1) honey bees are considered one of the most important 

pollinators globally from both a commercial and ecological perspective; and 2) 

standardized test methods for evaluating exposure and effects of chemicals in a 

regulatory context are more developed with the honey bee compared to non-Apis bees. 

Both the Introduction (Section 1) and the Problem Formulation sections (Section 2) of 

the white paper indicate that honey bees have historically served as a surrogate for other 

beneficial insects. As discussed in Section 5.3 of the white paper, there is uncertainty 

regarding the extent to which honey bees serve as surrogates for native species, especially

where life history strategies and differential sensitivity across species render native 

species more or less vulnerable to pesticides. 

a. Please comment on the extent to which the assessment of risks to the honey bee 

may serve to meet the protection goals identified in the white paper (i.e., 

protection of pollination services; protection of honey and hive product 

production; and protection of pollinator biodiversity).

b. Until guidelines are developed for testing non-Apis species of bees, please 

comment on the extent to which the honey bee may or may not serve as a 

reasonable surrogate for non-Apis bees, given the differences in life history 

strategies and potential different sensitivities to pesticide toxicants. Please include 

a discussion of which types of non-Apis bees may be particularly well represented 

by either the individual-level or colony level endpoints identified in Table 1 of the 

white paper; as well as which types of non-Apis bees may not be as well 

represented, and therefore, may be the focus of potential areas for future research

3:45 P.M. Charge Question 4

As discussed in Section 3 of the white paper, the magnitude of measured pesticide 

residues on bees and in plant matrices relevant to the diet of the bee vary considerably. 

At a screening level (Tier I), estimates of exposure are intended to be sufficiently

conservative to account for the observed variability so that there is a low likelihood that 

actual exposure would be greater than the values used in the screen. To accomplish this, 

the proposed methods described in the white paper use upper-bound estimates that 

approximate an upper 95th percentile confidence limit based on the distribution of 

measured residue values in relevant matrices.

Contact Exposure. The exposure characterization of the white paper (specifically, 

Section 3.1.1.2) proposes a screening-level (Tier I) approach for quantifying contact 

exposure to foraging bees for pesticides applied via foliar spray. This proposed method is 

based on the maximum of residue values on honey bees from a field study conducted by 

Koch and Weisser (1997). The white paper also discusses a method based on the T-REX 

upper-bound concentration for arthropods directly sprayed with pesticides while located 

directly on a treated field. Although the second method is not proposed for the Tier I 
6

exposure assessment for honey bees, it could be used to assess contact exposures to other 

insect pollinators.

a. Please comment on the strengths and limitations of the proposed approach for 

assessing contact exposures to honey bees in Tier I exposure assessments (i.e., 2.7 

μg a.i./bee per 1 lb a.i./A), which is based on the honey bee specific maximum 

concentration reported by Koch and Weisser (1997). 

b. Please comment on the potential utility of the T-REX upper-bound residue value 

(i.e., 12 μg a.i./bee per 1 lb a.i./A), for a broader number of arthropod species to 

represent contact exposures to honey bees and to other insect pollinators that are 

directly sprayed with pesticides. 

4:30 P.M. Charge Question 5 

Dietary Exposure (Consumption Rates). As discussed in the effects assessment section 

of the white paper (Section 4.1), acute oral toxicity data (LD50) are necessary for adult 

and larval bees in order to characterize the potential risks of a pesticide. Because these 

toxicity data are expressed on a dose basis (i.e., μg a.i./bee), it is necessary to convert 

estimated concentrations of pesticides in food (expressed as mg a.i./kg) into doses. Honey

bees fulfill their nutritional requirements through consumption of nectar, honey, and bee 

bread (pollen/honey). In addition to requiring bee bread and nectar or honey, bees also 

require royal jelly and brood food (jelly) to fulfill their nutritional requirements. In the 

proposed approach, it is assumed that exposures through consumption of nectar and 

pollen are conservative representations of potential exposures through consumption of 

honey and bee bread, respectively. This approach is likely to be conservative because it 

assumes that pesticides do not degrade while honey and bee bread are stored in the hive 

and have undergone some degree of processing (e.g., fermentation). For bees that 

consume honey, it is assumed that the estimated pesticide exposures can be related back 

to the original concentration in nectar by accounting for the amount of sugar consumed 

by bees. It is also assumed that pesticide exposures through consumption of pollen and 

nectar are protective of pesticide through consumption of royal jelly and brood food 

given that empirical data indicate that pesticide concentrations in royal jelly are a >100 

times lower than concentrations in food consumed by nurse bees. In the proposed 

approach, pesticide doses received by bees are calculated using nectar and pollen 

consumption rates for larval and adult worker bees. As discussed in detail in Appendix 1

of the white paper, the proposed values for larvae and adult workers are based on an 

analysis conducted by EPA, which built upon work published by Rortais et al. (2005), 

Crailshaim et al. (1992 and 1993) and others. For larvae, the proposed total food 

consumption rate is 120 mg/day, which is based on the total daily consumption of pollen 

and nectar (based on honey consumption) by larvae during day 5 of the uncapped larval 

life stage. For adult worker bees, the proposed food consumption rate is 292 mg/day, 

based on food consumption rates of nectar foraging bees, which are expected to receive 

the greatest dietary exposures among different types of worker bees. In addition, as 

discussed in Appendix 1, it is likely that these food consumption rates are protective of 

drones and queens. 
7

a. Although bee larvae typically consume processed foods in the form of royal jelly

and brood food throughout much of their development, they also consume honey

and pollen during the last two days of the uncapped period. Please comment on 

the proposed use of nectar and pollen consumption rates of larvae during the last 

day of the larval developmental stage. Please include a discussion of the 

conservatism, strengths and limitations of this approach as well as a discussion of 

how this value may or may not correspond to data generated from larval toxicity

endpoints.

b. Please comment on the strengths and limitations of basing the Tier I screen for 

adult honey bees on food consumption rates of nectar foraging bees, including a 

discussion of the conservatism of this approach, and how it relates to other types 

of worker bees and castes.

c. Please comment on the assumption that exposures through consumption of nectar 

and pollen are conservative representations of potential exposures through 

consumption of honey, bee bread, brood food and royal jelly, all of which 

represent processed foods.

5:30 P.M. Charge Question 6

Dietary Exposure. The dietary exposure methods described in Section 3.1 of the white 

paper differ in the nature of the estimated concentrations in pollen and nectar consumed 

by bees. For foliar spray applications, the proposed approach involves the use of the tall 

grass residue value from the T-REX model (v. 1.5) as a surrogate for pesticide 

concentrations in nectar and pollen. For soil treatments, the white paper proposes the use 

of the Briggs model, which is designed to estimate pesticide concentrations in plant 

shoots resulting from plant uptake of pesticides from treated soil. Estimated pesticide 

concentrations in plant shoots are proposed as a surrogate for concentrations in pollen 

and nectar. For seed treatments, the white paper proposes the use of the International 

Commission for Plant-Bee Relationships’ (ICP-BR) 1 mg a.i./kg concentration as an 

upper-bound concentration in nectar and pollen. The paper explores the strengths and 

limitations of each method relative to the ability to derive reasonably conservative 

estimates of pesticide exposures to bees, with a focus on how well the estimates relate to 

empirically based measures of pesticides in pollen and nectar from crops treated with 

pesticides. 

a. Foliar spray: Please comment on the analysis presented in Section 3.1.1.1, with a 

focus on the extent to which the T-REX tall grass upper-bound residue may serve 

as an adequate surrogate to represent upper-bound pesticide concentrations in 

pollen and nectar of flowers that are directly sprayed with pesticides.

b. Soil applications: Please comment on the analysis presented in Section 3.1.2, with 

a focus on the extent to which the Briggs’ model may generate estimates of 

pesticide exposure in plant stems that can represent upper bound pesticide 

concentrations in pollen and nectar of flowers.

c. Soil applications: Please discuss the relative strengths and limitations of the 1 mg 

a.i./kg value and the soil uptake model (the Briggs’ model) proposed in the white 

paper as Tier 1 screens, including consideration of the extent to which this method 
8

may generate conservative Tier I estimates of dietary exposures to bees. Does the 

Panel conclude that the one approach may be better suited to specific types of 

assessment scenarios? If so, please elaborate. Alternatively, if both approaches 

are equally suited for a Tier I screen, please provide guidance on how to be 

capture variability and uncertainty in the exposure estimates using the two 

approaches. 

d. Seed Treatments: Please comment on the analysis presented in Section 3.1.3, 

including a discussion of the strengths and limitations of the use of 1 mg a.i./kg 

value as an upper-bound concentration for pollen and nectar of seed-treated crops.

e. Please comment on other approaches or data that should be considered for 

estimating upper-bound estimates of pesticide residues in pollen and nectar as a 

Tier I screening-level assessment for pesticides applied via foliar spray, soil 

application or seed treatment. 

6:30 P.M. Adjournment
9

AGENDA

FIFRA SCIENTIFIC ADVISORY PANEL (SAP)

OPEN MEETING

September 11 – 14, 2012

FIFRA SAP WEB SITE http://www.epa.gov/scipoly/sap/

OPP Docket Telephone: (703) 305-5805

Docket Number: EPA-HQ-OPP-2012-0543

Potomac Yard One South

2777 Crystal Drive

Arlington, VA 22202

Pollinator Risk Assessment 

Thursday, September 13, 2012

9:00 A.M. Opening of Meeting and Administrative Procedures – Fred Jenkins, Ph.D., 

Designated Federal Official, Office of Science Coordination and Policy, EPA

9:05 A.M. Introduction and Identification of Panel Members -- FIFRA Scientific 

Advisory Panel (SAP) Chair, Daniel Schlenk, Ph.D.

9:10 A.M. Follow-up From Previous Day’s Meeting – Daniel Schlenk, Ph.D., FIFRA SAP 

Chair

9:20 A.M. Charge Question 7 

Consideration of other Exposure Pathways. The proposed measures of exposure are based 

on what are believed to be the primary routes, i.e., direct contact and ingestion of 

contaminated pollen and nectar. Additional routes of exposure are considered (e.g., dust, 

drinking water), but not included in the proposed Tier I exposure assessment method. As 

discussed in Section 3.1.4.1 of the white paper, effective quantitative screening methods for 

estimating exposures through contaminated dust are not discernible at this time. The most 

effective management of bees exposure to pesticides through dust appears to be through 

pesticide application (e.g., stickers) and seed planting practices, especially since dust 

exposure is expected to be a concern for only a limited number of pesticides and application 

scenarios. In regards to pesticide exposures through drinking water, Appendix 2 presents an 

analysis of potential exposures to bees through various sources of water to support the 

exclusion of drinking water exposure in the Tier I screen. The results of this analysis indicate 

that if bees consume the majority of their water from puddles or ponds, the exposures relative 
10

to dietary and direct spray are insignificant. The preliminary analysis indicates that if bees 

drink a substantial amount of water from guttation fluid or dew, conservative exposures may

be similar to or even exceed pesticide exposures through the diet or direct spray. Further 

investigation concluded that pesticide exposures through dew and guttation fluid are not 

expected to be as significant when compared to diet, primarily because they are not likely to 

consistently drink a substantial amount of water from these sources.

a. Please comment on the strengths and limitations of basing the Tier I exposure 

method on contact and diet. Does the Panel agree that for the majority of pesticide 

applications, the primary exposure routes for bees will be represented by contact 

and diet? 

b. Dust: If the Panel believes that this exposure route should be quantitatively 

included in the Tier I exposure method, for the relevant application type(s) (i.e., 

seed treatment), please discuss the data that may be needed to address the 

exposure route quantitatively.

c. Drinking Water: Please comment on the analyses, discussions provided in 

Appendix 2 of the white paper and the conclusion that pesticide exposure to bees 

through drinking contaminated water is not expected to be a major route of 

exposure when compared to contact (following foliar spray applications) and diet. 

If the Panel believes that this exposure route should be quantitatively included in 

the Tier I exposure method, for the relevant application type(s) (i.e., foliar spray, 

soil treatment, seed treatment, or trunk spray), please discuss why and what data 

may be needed to address the exposure route quantitatively.

d. Other Routes: Please identify and discuss additional exposure routes (if there are 

any besides contact with dust and consumption of drinking water) that would 

contribute significantly to pesticide exposure of bees and explain how and why

such exposures could be considered quantitatively in establishing the Tier I 

exposure value.

10:10 A.M. Break

10:25 A.M. Charge Question 8

Tier I Effects Assessments. As discussed in the Problem Formulation (Section 2.2.1), 

the assessment endpoints for the ecological risk assessment of bees involve maintaining 

honey bee population size, stability of managed bees, quality and quantity of hive

products, species richness and abundance. In order to use the results of toxicity studies 

quantitatively in risk assessment, it is important to identify specific endpoints which will 

be measured in toxicity tests as these measurement endpoints must have clear linkages to 

assessment endpoints. As indicated in Table 1 of Section 2.2.1, at the individual bee 

level (which is the focus of the Tier I assessment), measurement endpoints relevant to 

these assessment endpoints include: individual survival, adult bee longevity, brood size, 

brood success, and queen fecundity. The acute and chronic toxicity tests with larvae and 

adults can be used to quantify effects of pesticides on all of these endpoints, with the 

exception of queen fecundity (which would require an egg laying study involving the 

queen). The focus of the chronic toxicity tests with larvae and adults is on mortality that 

may occur during the tests. Potential impacts of a pesticide on brood size and success can 
11

be assessed by determining whether there is decrease in the number of brood (i.e., larvae) 

following a chronic exposure of larvae to that pesticide. Potential impacts of a pesticide 

on adult survival and longevity can be assessed by determining the mortality and the 

decrease in the life spans of adult bees following chronic exposures to the pesticide. The 

notable limitation to the proposed chronic toxicity endpoints is that they do not include 

measures of queen fecundity.

a. Please comment on the extent to which currently available bee toxicity tests,

which focus primarily on mortality/survival, serve as an effective Tier 1 screen.

b. Please comment on additional measurement endpoints (e.g., growth) which 

should be considered in future modifications of Tier 1 test protocols and which 

are appropriately linked to the proposed assessment endpoints. Given that the 

queen is the reproductive unit of the colony, please comment on methods to 

evaluate effects on individual queens, considering practical limitations of testing 

with queens.

11:25 A.M. Charge Question 9

Tier 1 Larval Toxicity Testing. Section 4.1 of the white paper discusses new data 

requirements for the screening-level effects assessment and recommends obtaining and 

using larval toxicity data on individual bees. The paper specifically identifies the assay

initially proposed by Aupinel et al. (2007) as one methodology for quantifying acute oral 

larval toxicity in the Tier I screen. These assays rely on feeding bees a sugar solution 

which has been spiked with the test material; however, this in vitro method of feeding 

larvae differs from the process by which the larvae would typically be fed within the 

colony environment, i.e. by nurse bees secreting either brood food or royal jelly.

a. Please comment on the extent to which the Aupinel et al. (2007) in-vitro method 

serves as an appropriately conservative estimate of Tier 1 acute oral exposure of 

honey bee larvae to pesticides, given differences in this test design from actual inhive exposure conditions (e.g., during the first 3 days of the larval development 

stage larvae consume royal jelly and brood food) and the uncertainty regarding 

the extent to which larvae rely exclusively on pollen/nectar as opposed to royal 

jelly/brood food.

b. Please comment on the extent to which pesticides would be more or less 

bioavailable using the synthetic matrix relied on for feeding developing bees in 

this in vitro method.

12:00 P.M. Lunch

1:00 P.M. Charge Question 9 (Cont’d)

c. Please comment on the extent to which the absence of trophallaxis (i.e., the 

transfer of food/fluids between colony members) may render larvae more or less 

vulnerable to pesticides.

d. Please comment on alternative methods for testing individual larvae that may be 

appropriate for quantitative use in a Tier I screening-level assessment.

e. Typically acute toxicity tests are concluded between 48 – 96 hrs. Please comment 
12

on the appropriate duration of toxicity tests for assessing acute toxicity to 

individual larval and adult bees.

1:30 P.M. Charge Question 10

Tier 1 Chronic Toxicity Testing Bees. Section 4.1.2 of the white paper discusses the 

status of chronic toxicity tests with individual adult and larval bees. At this time, no 

formal guidelines have been developed for conducting chronic toxicity tests with either 

adult or larval bees, although studies with individual bees of various ages are routinely

reported in open literature. 

a. Please comment on the conclusion that adequate procedures have not been 

sufficiently developed and validated for assessing chronic toxicity to individual 

bees in a risk assessment context.

b. Please comment on the potential use of the 10-d adult worker and 7-day in vitro

larval toxicity tests discussed in the white paper for assessing chronic toxicity

once these methods are fully vetted. 

c. Although 10-day adult and 7-day larval toxicity tests have been proposed, please 

comment on whether alternative durations of pesticide exposure may be more 

appropriate for determining chronic toxicity for adult and larval bees at a Tier I 

screen.

2:00 P.M. Break

2:15 P.M. Charge Question 10 (Cont’d)

d. The white paper identifies NOAEC as the chronic toxicity measurement endpoint. 

Please comment on the possible use of ECx values as a measure of chronic 

toxicity for use in RQ calculations.

e. Please provide comments on what percent effect would be considered a relevant 

measure of chronic toxicity for individual bees given the potential compensatory

effects which honeybee colonies may exhibit relative to the effects of pesticides.

f. Although the white paper identifies some measurement endpoints for assessing 

chronic toxicity to individual bees (e.g., survival), please comment on other 

endpoints to consider in chronic toxicity studies which the Panel believes are 

important and the associated study design elements.

g. Section 4.1.3 of the white paper discusses the uncertainties associated with 

developing risk assessments based on studies of sublethal effects when sufficient 

linkages have not been developed to understand how the sublethal endpoints may

be quantitatively related to typical assessment endpoints (i.e., growth, impaired 

survival, and reproduction) at the whole colony level. Please comment on the 

proposal to use data on sublethal endpoints to qualitatively (i.e., no Risk Quotient 

is derived) characterize effects and risk until sufficient linkages between these 

endpoints and the defined assessment endpoints have been developed (e.g., 

Adverse Outcome Pathways).
13

3:15 P.M. Charge Question 11

Tier II Semi-field Effects Assessments (Whole Colony). For Tier II assessments, 

Section 4.2 of the white paper identifies two types of test methods that may be used to 

assess colony-level effects, i.e., semi-field tunnel tests [OECD 75; EPPO 170]; and semifield feeding studies. These studies are intended to help characterize risks identified in 

the Tier I level assessment that are based on exposures and toxicity data for individual 

bees and quantified using Risk Quotients. 

a. Although colonies are typically confined to enclosures for Tier II studies and 

these enclosures can limit the environmental realism of the study conditions, 

tunnel studies provide an opportunity to collect colony-level effects and 

potentially exposure information. Please comment on the relative strengths (e.g., 

foraging activity by adult worker bees is limited to treated crop; trophyllaxis 

enabled) and limitations (e.g., limited study duration, smaller colony sizes, 

reduced forage area) of these methods.

b. Please comment on any other types of colony-level studies that should be 

considered as part of Tier II.

c. Please comment on the most important endpoints that should be measured in the 

Tier II studies (e.g., adult forage bee mortality, brood development, queen 

fecundity, overall colony strength) that are linked to assessment endpoints and 

their associated protection goals.

d. Section 4.2.2 of the white paper discusses a full-field feeding design. This 

methodology is discussed under Tier II assessments since the colony is relatively 

confined to foraging on either spiked sucrose solutions or spikes pollen. The 

intent of this methodology is to ensure that colonies are exposed to known residue 

levels over longer durations than the semi-field tunnel study designs. A limitation 

to the study is that bees may simply store spiked food rather than consume it and 

that the reliance on a single source of food may introduce confounding effects 

(e.g., nutritional deficits) into the study. Please comment on the environmental 

realism and utility of full-field feeding studies as a line of evidence in 

characterizing risk to honey bee colonies.

e. As discussed in Section 4.3.4 of the white paper, it is important to consider the 

biological significance of a measured effect in addition to its statistical 

significance. Please comment on the nature and magnitude of effects that would 

be sufficient to conclude biologically significant effects on the colony and/or the 

need to transition to Tier III assessments.

4:15 P.M. Charge Question 12

Tier III Effects Assessments. Section 4.3 of the white paper discusses the proposed risk 

assessment process in Tier III that relies on assessing effects at the colony level where colonies 

are not confined (i.e., full field) and exposure is intended to represent environmentally realistic 

conditions. As discussed in the white paper, interpretation of the biological significance of 

colony-level effects can be challenging, regardless of their statistical significance. Conversely, 

high variability in field studies can limit the statistical power of the study to detect treatment 

effects. The paper identifies uncertainties associated with the extent to which bees forage on the 
14

treated crop, the size of treatment site, controlling for alternative forage/pesticide use area, and 

ensuring suitable controls; these factors combine to render these studies highly resource 

intensive. 

a. Please comment on the strengths and limitations of full field studies described in 

the white paper.

b. Please comment on the proposed modifications to the field study design elements 

presented in Section 4.3.2 of the white paper.

c. Please comment on factors that should be considered in evaluating the biological 

significance of effects measured in full-field studies in relation to the proposed 

assessment endpoints and related protection goals. 

d. Please comment on factors and methods that should be considered when 

extrapolating observed effects at the colony level in semi-field and field studies to 

those expected to occur in the environment (e.g., spatial and temporal scale of 

exposure, hive management practices, presence of multiple chemical and nonchemical stressors, etc). 

e. A number of study design elements are discussed in Section 4.3.5 of the white 

paper; however, even in the best designed studies, there can be confounding 

effects which can limit the utility of these studies in risk assessment. Please 

comment on factors that should be considered in determining the utility of field 

studies for pesticide risk assessment, including a discussion of the 

representativeness of a study for a National Level assessment (i.e., the pesticide 

may be used anywhere in the United States and its territories).

5:30 P.M. Adjournment
15

AGENDA

FIFRA SCIENTIFIC ADVISORY PANEL (SAP)

OPEN MEETING

September 11 – 14, 2012

FIFRA SAP WEB SITE http://www.epa.gov/scipoly/sap/

OPP Docket Telephone: (703) 305-5805

Docket Number: EPA-HQ-OPP-2012-0543

Potomac Yard One South

2777 Crystal Drive

Arlington, VA 22202

Friday, September 14, 2012

9:00 A.M. Opening of Meeting and Administrative Procedures – Fred Jenkins, Ph.D., 

Designated Federal Official, Office of Science Coordination and Policy, EPA

9:05 A.M. Introduction and Identification of Panel Members – FIFRA Scientific 

Advisory Panel Chair, Daniel Schlenk, Ph.D.

9:10 A.M. Follow-up From Previous Day’s Meeting – Daniel Schlenk, Ph.D., FIFRA SAP 

Chair

9:20 A.M. Charge Question 13

Risk Estimation. Sections 2 (Proposed Risk Assessment Process) and 5 (Risk 

Characterization) of the white paper indicate that the proposed risk assessment process is 

intended to be tiered and iterative. As part of the Tier I screen, a number of iterations can 

be conducted on exposure estimates that allow the risk quotient (RQ) values to be further 

refined and potentially pass the screen without requiring higher tier effects testing at the 

semi- or full-field level. However, while the proposed Tier I process for bees is 

quantitative and results in an RQ value which can in turn be compared to a Level of 

Concern (LOC), higher tier refinements are used to qualitatively (i.e., no RQ derivation) 

determine whether whole hives will be adversely affected from the use of a pesticide 

based on the initial screening-level assessment.

a. Please comment on the use of data on individual bees to transition to higher tier 

studies given that the Tier I studies focus on survival as the primary measurement 

endpoint although additional endpoints may be forthcoming as test designs 

continue to develop.

b. Please comment on the derivation of the Level of Concern, i.e., LOC=0.4) and the 

extent to which is serves as an appropriate screen to transition to higher tiers of 
16

testing/refinement.

c. Please comment of the quantitative aspect of the screening-level (Tier I) 

assessment and the use of Tier II and Tier III whole hive studies to qualitatively

characterize risk.

d. Please comment on the assumption that the effects on individual bees measured in 

laboratory studies must be considered in the context of whole colony studies 

conducted under semi-field and full-field conditions.

e. Please comment on the proposed use of a weight-of-evidence approach based on 

information obtained from multiple tiers of risk assessment for characterizing 

pesticide risks to honey bees.

f. Please comment on to how best to characterize overall uncertainty or weigh 

different areas of uncertainty in risk characterization. 

g. Please comment on how to focus/prioritize uncertainties when designing and 

interpreting Tier II and Tier III studies.

10:30 A.M. Charge Question 14

Colony-level Modeling. As part of the proposed risk assessment process, Section 5.4 of 

the white paper discusses the concept of using colony-level models as a means of integrating 

exposure and effects information generated from the multiple risk assessment tiers and in 

turn linking this information quantitatively to the proposed assessment endpoints. 

Conceptually, such models could inform the need for transitioning from lower tiers to higher 

tiers in the risk assessment process. They could also be considered in identifying critical 

design elements of higher tier studies (e.g., semi-filed or full field studies).

a. Please comment on the concept of using colony-level ecological models to inform 

the proposed risk assessment process for honey bees, as indicated above.

b. Please comment on the state of the science regarding available honey bee models 

discussed in Section 5.4.2 of the white paper in relation to their potential 

application in a regulatory risk assessment context. In particular, please comment 

on the extent that such models have been evaluated using empirical data related to 

honey bee population dynamics and the availability of such data for their 

parameterization.

c. Please comment on the most important elements that should be considered in 

reviewing available honey bee colony ecological models for potential application 

in risk assessments.

12:00 P.M. Adjournment

Please be advised that agenda times are approximate; when the discussion for one topic is 

completed, discussions for the next topic will begin. For further information, please contact the 

Designated Federal Official for this meeting, Dr. Fred Jenkins, via telephone: (202) 564-8432; 

fax: (202) 564-8382; or email: Jenkins.Fred@epa.gov.