-

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF CHEMICAL SAFETY

AND POLlfJTIOIi PREVENTION

MEMORANDUM

June 12,2012

PC Code: 125401

DP Barcode: 384746

SUBJECT:

FROM:

Response to comments submitted by the public on preliminary ecological risk

assessment for c1omazone 1/1JtL! . ·,h~/l1- Kristina Garber, Senior Biologist Mf~

James Lin, Environmental Engineer6~ Li"N

Environmental Risk Branch II

Environmental Fate and Effects Division (7507~)

REVIEWED Edward Odenkirchen, Senior Science Advisor

BY: Environmental Risk Branch I

Environmental Fate and Effects Division (7507P) '/1'1 III

R. David Jones, Senior Agronomist I'< t)w(2 '~~aq''' Environmental Risk Branch II /'

Environmental Fate and Effects Division (7507P)

THROUGH: Brian Anderson, Chief !!"I4-~--­ Environmental Risk Branch II

Environmental Fate and Effects Division (7507P)

TO: Jose Gayoso, Chemical Review Manager

Tom Myers, Team Leader

Risk Management and Implementation Branch II

Pesticide Re-Evaluation Division (7508P)

In 2009, EPA completed draft ecological risk assessments for c1omazon~ and fomesafen and

requested public comment. These are the first two national ecological risk assessments and

endangered/threatened species effects determinations for conventional pesticides, conducted

within the context ofEPA's registration review program. Clomazone and fomesafen are

herbicides used to control weeds and grasses in a variety of crops and noil-crop locations. The

Agency's primary risk concern for both herbicides is direct effects on terrestrial plants, and

associated indirect effects on listed species dependent on plants. The risk assessments indicate

that the use of clomazone or fomesafen is likely to adversely affect a variety oflisted species and

may affect elements of designated critical habitat influenced by effects to plants. In conducting

these first two national listed species assessments and effects determinations, EPA explored

Page 10f35
effective and efficient methods of identifying the universe of species that may be exposed and 

affected by the uses of these pesticides. While the fomesafen assessment used standard 

geographical tools refined with expanded biological characteristics, the clomazone assessment 

used refined geographical proximity analyses in determining what species might and might not 

be exposed to the pesticide at levels of concern. Although the Agency explored new methods, 

both methods were considered to produce protective measures of potential risk. EPA’s risk 

assessments for clomazone and fomesafen are consistent with scientific procedures outlined in 

the Agency’s Ecological Risk Assessment Process1

, which is EFED’s current practice for 

conducting ecological risk assessments and effects determinations for pesticides. 

The focus of this memo is on the public comments that were submitted on the draft clomazone 

ecological risk assessment, which was submitted to docket EPA-HQ-OPP-2006-0113. Nine sets 

of comments were submitted to EPA that have potential relevance to EFED’s Ecological Risk 

Assessment (ERA) on clomazone. These comments were submitted by: 

- the National Potato Council, 

- the Center for Regulatory Effectiveness, 

- the Agricultural Retailers Association, 

- the National Cotton Council (NCC), 

- Crop Life America (CLA), 

- FIFRA Endangered Species Task Force (FESTF), 

- the California Rice Commission (CRC), 

- the Florida Department of Agriculture, and 

- the North Dakota Florida Department of Agriculture. 

The comments that are addressed by EFED are included below. EFED’s response to each 

comment is in italics. Comments submitted by the public are divided up by topic, including: 

clomazone use, characterizing exposure, characterizing effects, risks, action area and listed 

species effects determinations. 

ERB2 acknowledges the contributions of the following EFED scientists in completing this 

memo: Brian Kiernan, Faruque Khan, Anita Pease, Melissa Panger, William Eckel, Melissa 

Grable and Ed Odenkirchen. 

Clomazone Use:

1) NCC Comment: “In its estimation of the effect of clomazone on birds and mammals, the 

Agency used an application rate of 3 lb a.i./acre for a banded application. This rate is twice 

that of the label rate, the legal maximum that can be applied. When the correct rate is used in 

the model, clomazone poses a negligible risk to birds and mammals.”

 

1

 USEPA. 2004. Overview of the ecological risk assessment process in the Office of Pesticide Programs, U.S. 

Environmental Protection Agency. Endangered and Threatened Species Effects Determinations. United States 

Environmental Protection Agency, Office of Pesticide Programs. Available online at: 

http://www.epa.gov/espp/consultation/ecorisk-overview.pdf. 

Page 2 of 35 
Similarly, CLA also commented: “T-REX modeling for direct exposure to birds and 

mammals utilized incorrect application rates that overstated exposure, and thus risk, by a 

factor of two.” 

EFED Response: According to the Ecological Risk Assessment (ERA), the highest single 

application rate for clomazone is 1.5 lb a.i./A (for use on sweet potato). This rate was used to 

estimate exposures of non-target aquatic and terrestrial organisms to clomazone (i.e., with 

PRZM/EXAMS, T-REX and TerrPlant).The assessment also considered exposures of 

terrestrial animals resulting from a banded clomazone application to sweet potatoes at a rate 

of 3.0 lb a.i./A. Resulting exposures are representative of clomazone concentrations on food 

items located within the band. This approach assumes that the concentration of clomazone is 

higher within the band, but the average application rate of clomazone over the entire field is 

1.5 lb a.i./A. This approach was intended as a screen, where the worst-case exposure was 

simulated for clomazone. Based on this screen, it was determined that clomazone may affect, 

but is not likely to adversely affect (NLAA) listed species of land mammals, birds, amphibians 

and reptiles. Therefore, it was not necessary to refine the conservative screen. 

2) CLA Comment: “Maximum labeled use rates were incorrectly interpreted and used in the 

assessment process.” 

EFED Response: Maximum labeled use rates for clomazone were based on current 

formulated product labels. 

3) t of Agriculture Comment: “The authors state that the maximum us

of clomazone on soybeans is 1.25 lb a.i./A, but the label of Commence EC herbicide from 

FMC corporation (EPA registration #279-3104) has a use rate on soybeans of 1.75 lb ai/A.” 

North Dakota Departmen e 

FED Response: Commence EC herbicide (EPA registration #279-3104) is a formulated 

4) RC Comment: “Water management is critical in California rice production. Rice growers 

-day 

vel 

FED Response: The Tier I rice model used in the clomazone ERA assumes a water depth of 

haracterizing Exposure: 

E

product that contains both clomazone and trifluralin. The highest application rate of this 

product on soybeans (i.e., 2.67 pts/A) corresponds to an application of 1.75 lb a.i./A when

considering both clomazone and trifluralin. In terms of clomazone only, this rate applies to

0.69 lb a.i./A. 

C

maintain the water depth at four to five inches to promote maximum tillering while 

maintaining some weed control. The Cerano®5MEG label requires a mandatory, 14

water hold for maximum efficacy and allow degradation of the product to an acceptable le

before release.” 

E

0.1 m, which is equivalent to 4 inches. This is consistent with the water depth used by CA rice 

growers indicated by CRC. In the clomazone ERA, EFED considered the effects of the 14 d 

holding period on the concentration of clomazone by accounting for degradation during that

time. 

C

Page 3 of 35 
1) LA Comment: “Chronic risk assumptions about small and medium-sized mammals were 

FED Response: Chronic RQs exceeded the LOC (1.0) for small and medium mammals 

-

mals. 

f the 

L) 

) CLA Comment: “In evaluating effects on reptiles and terrestrial phase amphibians, EPA ran 

FED Response: The T-REX model is used as a screen to estimate exposure and subsequent 

not 

) CLA Comment: “T-REX did not take into consideration what food types would actually be 

EFED Response: On p. 75 of the ERA, EFED stated “Because clomazone is applied as a 

e 

 for 

) CLA Comment: “Approaches to refine exposure estimates based on vapor-phase transport 

were based on provisional methods that were neither internally or externally peer reviewed.” 

 C

not refined as planned.” 

E

consuming grass, broadleaf plants and small insects. On p. 108 of the ERA, EFED 

characterized the risks associated with these LOC exceedances by considering the 2

generation rat reproduction study used to derive the chronic toxicity endpoint for mam

EFED concluded that “although the dose-based chronic RQ values exceeded for some 

mammals indicating a potential for reproductive effects of concern further evaluation o

type and degree of expected effects indicate that reproductive effects are not expected at 

these residue levels.” This consideration of the effects associated with the NOAEC (NOAE

of the 2-generation rat reproduction study constitutes a refinement, which resulted in a 

NLAA determination for direct effects to listed mammals that consume grass, broadleaf 

plants and insects. 

2

the spreadsheet model ‘T-REX’ instead of using the ‘T-HERPS’ model, which was designed 

expressly for the estimation of risk to reptiles and amphibians. 

E

risks to terrestrial-phase amphibians and reptiles. In this approach, dietary and dose-based 

exposures to birds are assumed to be conservative representations for terrestrial-phase 

amphibians and reptiles. No avian RQs exceeded LOCs, indicating that clomazone does 

pose a risk of direct effects to non-listed and listed species of birds and terrestrial-phase 

amphibians and reptiles. If avian RQs did exceed LOCs, T-HERPS may have been run to 

refine the estimates of clomazone exposure to terrestrial-phase amphibians and reptiles. 

3

present in the field at the time of pre-emergent application.” 

pre-emergent soil treatment or early pre-emergent (i.e., applied at the one-or two-leaf stag

of target plants) dietary items such as short grass, tall grass, small broadleaf plants, fruits 

and pods would be essentially minimal to non-existent on conventional tilled fields resulting

in reduced or nonexistent exposure to the predicted upper bound residue levels for these 

items. Clomazone can be applied as a soil treatment under conservation-tillage systems 

(minimum-till or no till) for cotton and soybean. In these systems, there is some potential

these dietary items to be represented on-field.” Therefore, for clomazone use on cotton and 

soybeans, all dietary items considered using T-REX are relevant. RQs representative of these 

uses exceed the LOC for mammals for some food items. For all other uses, primarily insects 

and seeds are expected to be on the target area. For banded applications to sweet potatoes, 

RQs for mammals consuming small insects exceed LOCs for acute and chronic exposures. 

4

Page 4 of 35 
EFED Response: As recommended by Scientific Advisory Panel (SAP) in December 2009 

meeting to address Field Volatilization of Conventional Pesticides, EFED will use the 

d 

ening 

5) lomazone was greatly overstated based on an empirical 

odel that was not peer reviewed or validated for clomazone. Consequently, the predictions 

ed that the volatilization analysis based on the work of 

(Yang and Holmen) will be withdrawn from the clomazone assessment, as it was not fully 

6) hile EPA 

is estimating volatilization as high as 65%, laboratory data which has been submitted to the 

 will be 

sed to estimate the volatilization flux as recommended by SAP. As for the submitted 

er 

7) ply assumes 1% drift for 

und application and 5% for aerial applications. Would it be more appropriate to use 

 to use model 

enerated drift fractions in the risk assessment and mitigation processes. One of the major 

 label 

8) ts, EPA conducted a Tier I 

assessment using TerrPlant, rather than conducting refined acute estimates. Since non-target 

Woodrow et al. (1977) correlation approach to estimate a maximum 24-hour flux value an

then could be used to calculate a maximum air concentration over 24-hours for the scre

purpose. 

CLA Comment: “Volatilization of c

m

made using those parameters are highly questionable. Registrant-submitted and published 

studies on clomazone demonstrate that EPA-OPP overstated the volatilization of clomazone 

by at least an order of magnitude.” 

EFED Response: EPA has determin

vetted by EFED technical teams (as stated in the original assessment). Instead, all observed

incidents of plant damage will be assumed to have been caused by the lesser amounts of 

volatilization demonstrated in the submitted laboratory and field volatility studies. 

NCC Comment: “EPA has grossly overestimated the volatilization of clomazone. W

Agency show that the volatilization of clomazone is significantly less than 10%.” 

EFED Response: As stated in #4, the Woodrow et al. (1977) correlation approach

u

laboratory studies, they are currently under review. Although the results may indicate low

than 10% volatilization, they are for specific test conditions. Volatilization under field

conditions are expected vary from those in the laboratory due to differences in relative 

humidity, wind speed, temperature and spray formulation. 

 

FL Department of Agriculture Comment: “Drift component sim

gro

AgDRIFT modeling based on the droplet requirements on the label?” 

EFED Response: EFED concurs with the Florida Dept of Agriculture

g

obstacles for modeling was the lack of specific application parameters in the product

such as droplet size, release height and wind speed as well as other factors that can affect 

spray drift. These are critical factors influence drift predictions. The Agency is taking 

various steps to include these application parameters in the product label. In addition, in 

absence of specific parameter related to application, OPP is developing a strategy to 

implement AgDRIFT/AGDISP modeling for future assessments instead of using current 1%

drift for ground application and 5% for aerial applications. 

CLA Comment: “In refining risk estimates for terrestrial plan

Page 5 of 35 
plants are at potential risk from the use of clomazone, an herbicide, a refined assessment 

the preferred approach.” 

EFED Response: EFED w

is 

ill incorporate the more refined models, such as AgDRIFT to 

ddress potential exposure to terrestrial plant species with spray drift. Methodology to 

ent. 

 to risk 

9) mment: “The runoff component of the [TerrPlant] model 

s a "runoff value" sed on the solubility of the chemical. This is a rather simplistic 

t assessments are likely to result in label revisions and 

itigations (i.e., buffers) for herbicides to protect listed plant species, the Department would 

pesticide exposure to terrestrial plant species. The Agency acknowledges that the simplicity 

t to 

 edge 

10) ure Comment: “What is the basis for assuming that channelized 

loading from 10 acres versus sheet flow from 1 acre results in l0x the runoff into a 

e: TerrPlant's 10 to 1 ratio of target area to semi-aquatic non-target area is 

based on research conducted in a pond located in Georgia with a 6-7 foot typical depth and 

tic 

11) omment: “The effectiveness of existing mitigations (buffers on current labels) was not 

fully considered in refining exposure estimates, partly due to an over-reliance on modeling 

that is not scientifically defensible.” 

a

evaluate potential exposures to terrestrial plants via runoff are currently under developm

These methods will be used after they have been fully vetted and approved for risk 

assessment. However, given that incidents have occurred at 1 to 2 miles from treated fields, 

refining spray drift and runoff exposure assessments is unlikely to result in changes

conclusions or species at risk. 

 

FL Department of Agriculture Co

use ba

approach. Would it be more appropriate to use PRZM modeling to determine the amount of 

loading into a surface water body?” 

“Considering that these non-target plan

m

suggest that these issues be brought before EPA's Scientific Advisory Panel for review.” 

EFED response: At this time TerrPlant is the accepted Agency model for estimating 

of these assumptions contributes to uncertainty in Agency risk assessment. In an effor

reduce uncertainty, AgDRIFT (or AgDISP) is currently used in accordance with EFED 

guidance to refine the spatial extent of potential exposure to terrestrial plant species when

risk from spray drift is indicated by the TerrPlant model. There is currently no vetted 

refinement for exposure to terrestrial plants from runoff. The Agency is interested in 

exploring options for refinement of the runoff model, including using PRZM to estimate

of field pesticide loading. 

FL Department of Agricult

waterbody?” 

EFED respons

a requirement of 2-acre drainage areas per foot of depth (USDA 1997). Although the data 

are derived from observations of aquatic areas (e.g., farm ponds), it is assumed that this 

ratio is relevant to low-lying semi-aquatic areas. There is some uncertainty associated with

the depth of the ponds used for modeling purposes and the expected depth of a semi-aqua

area. 

CLA C

Page 6 of 35 
EFED Response: The effects of buffer mitigation on spray drift can be addressed with the 

AgDRIFT (or AgDISP) model to quantitatively estimate the drift loading according to the 

buffer length, then the drift loading can be used in the exposure models to derived the 

xposure concentrations. However, spray drift buffers of at least 1000 ft are in place are 

r the 

12) uality 

ltural commissioners and industry members resulted in best 

anagement practices to effectively mitigate negative impacts from rice pesticides. The CRC 

ition 

C50 

re from registrant submissions and the 

scientific literature. EFED did not use the monitoring data cited by CRC in the draft 

. 

Ch

1) onstrated 

hat re known to occur in close proximity to the application 

site. Using impacts determined by exposure to surrogate species in a laboratory setting is not 

f those impacts on wild species that occur in fields, wetlands or 

test effects on the endangered species themselves. EFED agrees that mitigation 

measures should be as specific as possible. 

 

e

current labels are in place to protect “Towns and subdivisions, Commercial Vegetable 

Production, Commercial Fruit Production, Commercial Nurseries, and Commercial 

Greenhouses”, and not wildlife habitat. Clomazone labels do not include any buffers fo

mitigation of runoff. 

 

CRC Comment: “In California, the CRC has a thirty-year history of managing water q

programs relative to pesticide use. Collaboration with the University researchers, State 

agencies, county agricu

m

requests that the registrants monitor pesticides in surface water the first year of registration. 

In addition, monitoring of agricultural discharges, for all crops, takes place through the 

Irrigated Lands Regulatory Program (ILRP). The CRC is a commodity-specific coal

managing rice surface water issues under the ILRP. Clomazone monitoring took place during 

the use season in 2003, the post season in 2006 and 2007, and the use season in 2008 and 

2009. The monitoring results indicate no toxicity in comparison to the lowest LC50 and E

numbers found in the AQUIRE ECOTOX database.” 

EFED Response: In the draft ecological risk assessment for clomazone, exposures of nontarget aquatic organisms were characterized using estimated values from modeling and 

empirical data from field studies. The field studies we

ecological risk assessment. EFED is interested in the monitoring data that CRC references

Although some of these data are available online2

, EFED recommends that PRD contact

CRC and request any additional data that CRC would be willing to provide. EFED will 

consider these data when developing the revised exposure characterization for the 

clomazone risk assessment. 

aracterizing Effects: 

National Potato Council comment: “Mitigation measure should be triggered by dem

impacts on particular species t a

an adequate measure o

riparian areas where the vegetation is a complex array of natural species. Mitigation 

measures need to be as specific as possible. Designing large nationwide, state wide or even

county wide areas for mitigation is unworkable and inconsistent with a focused science based 

approach.” 

EFED Response: EPA’s current process is to use impacts determined by exposure to 

surrogate species in a laboratory setting to assess potential impacts on wild species, as it is 

unlawful to 

2

 http://www.swrcb.ca.gov/rwqcb5/board_decisions/adopted_orders/waivers/r5-2010-0805_mrp.pdf 

Page 7 of 35 
CLA Comment: “Risk refinements for estuarine and marine invertebrates were based on 

inappropriate endpoints, such as using an Acute to Chronic Ratio (ACR) derived from fish 

when an ACR from invertebrates was availab

2)

le.” 

tes 

acute endpoint for estuarine/marine 

vertebrates. This ACR was derived from acute and chronic toxicity data available for the 

EFED Response: No chronic toxicity data were available for estuarine/marine invertebra

exposed to clomazone. In order to estimate a chronic endpoint for estuarine/marine 

invertebrates, EFED applied an ACR of 8.3 to the 

in

rainbow trout, a freshwater fish. This value was used instead of an ACR for a freshwater 

invertebrate (2.454 for Daphnia magna). Because there were no additional toxicity d

determine whether or not there is a taxonomic effect on ACR and because the two ACRs

within a factor of 10, it was assumed that there is no taxonomic effect on ACR. Therefore, th

more conservative ACR was used. If valid chronic estuarine/marine toxicity data become 

available, it will be considered in the risk assessment. 

CLA Comment: “Two publications on the silver catfish (Rhamdia quelen, Heptateridae), a 

species which is exclusively neotropical, were used as the basis for risk assessment and 

effects determinations, yet these publications were defi

ata to 

 are 

e 

3)

cient in multiple ways (test species, 

ocumentation, nominal concentrations unconfirmed by analysis, unclear units of 

-

antos 

 assessment for clomazone. EFED will revise the 

ssessment using the 96-h LC50 of 19 mg/L, which corresponds to exposures of rainbow trout 

4) ffects 

he assessment endpoints for indirect effects to listed species, in these first two cases on 

nificant 

damage to a high percentage of the plants in the community. However, no standard is 

y. 

 

d

concentration, and many more flaws that would make this study ‘invalid’ under normal EPA

OPP data evaluation procedures).” 

EFED response: EFED has reviewed the publications indicated by CLA (i.e., dos S

Miron et al. 20043 and 20054) and agrees that these data should not have been used 

quantitatively in the ecological risk

a

to technical grade clomazone (ACC#248475). 

CLA Comment: “A consistent and credible method for the determination of indirect e

and impacts on designated critical habitat (under ESA) needs to be developed. 

T

herbicides, are for effects on plant populations and communities. Ecologically significant 

changes in population dynamics and community composition would require sig

available to define what is ecologically significant and thus the agency defaults to the 

precautionary assumption that more-or-less all listed species (all taxa) are affected indirectl

This assumption is not true in reality and it is not supported by data. 

3

 dos Santos Miron, D., Da Silva, L. V. F., Golombieski, J. I., De Oliveira Machado, S. L., Marchezan, E., and 

Baldisserotto, B. (2004). Lethal Concentration of Clomazone, Metsulfuron-Metil, and Quinclorac for Silver Catfish, 

Rhamdia quelen, Fingerlings. Ciencia Rural 34: 1465-1469. 4

 dos Santos Miron, D., Crestani, M., Rosa Shettinger, M., Maria Morsch, V., Baldisserotto, B., Angel Tierno, M., 

Moraes, G., and Vieira, V. L. P (2005). Effects of the Herbicides Clomazone, Quinclorac, and Metsulfuron Methyl 

on Acetylcholinesterase Activity in the Silver Catfish (Rhamdia quelen) (Heptapteridae). Ecotoxicol.Environ.Saf. 

61: 398-403 

Page 8 of 35 
With respect to critical habitat, the clomazone assessment attempted to deal with it in d

while the fomesafen assessment took a broad-brush approach. References to critical habitat 

throughout the clomazone assessment do not seem to reflect an under

etail 

standing of the legal 

definition of designated critical habitat and the Services’ obligation of evaluating actions 

e 

rcumstances that contribute to species’ protection or lack of 

exposure. 

es that will vary seasonally as to plant height and biomass. They will vary yearly 

due to normal variations in temperature and rainfall; these factors can change plant 

grazing 

ssional 

, field 

g 

e 

h 

roach 

tly, the analysis of indirect effects to listed 

species provides the basis for an analysis of potential effects on designated critical habitat 

population) values from both seedling emergence and vegetative vigor guideline studies for 

within it. EFED also seems to have done nothing to specifically deal with primary 

constituent elements (PCEs), in order to utilize those as screening criteria for whether or not 

designated critical habitat might be affected. If these elements are not in the vicinity of an 

application, even if the application is within or near designated critical habitat, there may b

no need for further assessment. 

Of even more concern are the two drastically different approaches taken to address indirect 

effects in the two assessments, neither of which was undertaken in a manner that thoroughly 

and scientifically analyzes the ci

In addition, the inherent variability in vegetation that non-target species are likely to 

encounter in the wild should be considered. For example, species may inhabit different plant

communiti

population dynamics. The communities could also be subjected from time to time to 

or to catastrophic events, such as severe or prolonged drought or wildfires. Plant 

communities also will vary over longer periods of time as plant succession occurs. Most 

species are adapted to these seasonal changes, yearly changes, and possibly to succe

changes that occur. Standard EFED risk assessment procedures used for herbicides are 

overly conservative in predicting risks for non-target plants. Application practices

studies, observations from field trials, and many other factors are considered in establishin

use parameters that mitigate risk, and these factors are extremely important to consider in the

risk assessment, particularly when multiple underlying assumptions grossly exaggerate th

presumed indirect effects and impact on designated critical habitat. Furthermore, in 

extrapolating risk from non-target plant testing, (1) the testing procedures have limited 

relevance to the plant stages occurring in the field; (2) test plant exposure has limited 

relevance to exposure in the field; and (3) measured endpoints are not readily translated to 

effects on populations and communities in the field. As a consequence, herbicide specific 

characteristics such as mode and mechanism of action, application methods and time, 

spectrum of activity and selectivity and the nature or severity of effects are critically 

important to the interpretation of impact, but the evaluation of these factors is lacking in bot

the clomazone and fomesafen assessments.” 

EFED Response: The Agency acknowledges the uncertainties associated with the app

used to evaluate indirect effects and impacts on designated critical habitat for national-level 

endangered species risk assessments. Curren

and follows EFED’s current practice identified in US EPA (2004). 

With respect to terrestrial plants, the EC25 (effect concentration to 25% of the test 

Page 9 of 35 
both Monocotyledones (monocots) and Dicotyledones (dicots) are used as the measurement

endpoints to determine the potential for ecologically significant direct effects to plants and 

indirect effects to those listed species that rely on multiple plant species to successfully 

alue is 

n of 

e 

 

ce for 

od, water, air, light, minerals, 

or other nutritional or physiological requirements; cover or shelter; sites for breeding, 

s of 

the 

d 

eight5) icity or 

.” 

EFED Response: Clomazone is practically non-toxic to birds, with no mortality observed at 

a 

od 

complete their life cycle. The NOAEC (no observed adverse effect concentration) v

used as the measurement endpoint for direct effects to listed plant species and indirect effects

to listed species that rely on a specific plant species in their life cycle (termed plant species 

obligates). Guideline studies generally evaluate toxicity to ten crop species. A drawback to

these tests is that they are conducted on herbaceous crop species only, and extrapolatio

effects to other species, such as woody shrubs and trees and wild herbaceous species, 

contributes uncertainty to risk conclusions. While it is recognized that the current battery of 

required guideline terrestrial plant toxicity tests for pesticides is limited in characterizing th

sensitivity of all types of vegetation that non-target species are likely to encounter in the wild,

the Agency attempts to make use of the best available information by considering relevant 

data from the open literature as well as any registrant-submitted studies that provide 

additional information on the variable sensitivity of plants. 

Given the large number of listed species for which critical habitat exists, a specific analysis 

of each primary constituent element (PCE) for each designated critical habitat for each 

listed species was not completed. In general, PCEs include, but are not limited to spa

individual and population growth and for normal behavior; fo

reproduction, rearing (or development) of offspring; and habitats that are protected from 

disturbance or are representative of the historic geographical and ecological distribution

a species. Given that terrestrial plants serve as habitat, shelter, food, and/or cover for a 

variety of invertebrate and vertebrate listed species, the Agency presumes that direct effects 

to terrestrial plants may result in modification of designated critical habitat. However, 

Agency acknowledges the need for further evaluation of indirect effects to listed species an

potential critical habitat modification, and anticipates that a species- and critical habitatspecific analysis will be completed as part of consultation with the Services. In the 

meantime, it is recognized that further development of methodologies to characterize 

potential modification of PCEs and associated designated critical habitat as well as indirect

effects analysis to listed species is needed. If available, these new methodologies will be 

incorporated into the revised clomazone registration review risk assessment. If new 

methodologies to evaluate indirect effects are not available at the time of the revised

assessment, the Agency will attempt to refine the indirect effects analysis based on a w

of-evidence approach using the best available information, and thereafter based on 

consultation with the Services. 

CLA Comment: “EPA estimated LD50 or LC50 values from studies that showed no tox

lethality at limit doses (single dose limit studies), using a non-peer reviewed, unvalidated 

procedure to extrapolate from the tested limit concentration to an LD50 or LC50 value

the highest treatment levels in acute and sub-acute studies conducted with bobwhite quail 

and mallard duck. In order to estimate the LD50 and LC50 values for birds, EFED applied 

provisional method based on the dose-response curve and slopes ranging 2-9. This meth

Page 10 of 35 
was used for characterization only. Based on several lines of evidence, EFED concluded that 

6)

f 

 damage because individual plants typically 

outgrow the damage.” 

s 

cal needs of individual listed species are not available to the agency 

t this time. In the clomazone ERA, EFED used available seedling emergence and vegetative 

d 

f effects to plants 

at are visible to the observer, including bleaching. NOAEC values for phytotoxicity, dry 

acute exposures do not pose risks to birds and terrestrial-phase amphibians and reptiles. 

NCC Comment: “EPA states that the establishment of such an extensive action area ‘is based

on the farthest physical direct or indirect effects from exposure to clomazone’. It is unclear i

EPA is taking into consideration the fact that plants may recover from ‘bleaching’ and how 

such an effect relates to ESA regulations.” 

Similarly, CLA commented: “Plant recovery, an important area of refinement for clomazone, 

was not considered in refining the risk equation for plants and indirect effects in general. The 

bleaching effect of clomazone is obvious as a diagnostic tool, but as a symptom does not 

necessarily indicate ecologically significant

EFED Response: The action area is defined as the area where effects may reasonably be 

expected to occur. Data allowing EPA to evaluate the degree to which recovery occurs, it

rapidity of onset and time required to return to normal vegetative standing coupled with 

information on the criti

a

vigor studies as well as incident reports of clomazone effects on plants. This information 

indicated that exposure to clomazone can affect plants for months to years after exposure. 

Therefore, recovery was not considered in the ecological risk assessment. 

Appendix B (Table B8) of the ecological risk assessment provides seedling emergence data 

for 10 plant species exposed to technical clomazone. Along with the growth endpoints use

quantitatively for ecological risk assessment (i.e., dry weight and plant height), NOAEC 

values are listed for “phytotoxicity.” Phytotoxicity is a subjective measure o

th

weight and height from a seedling emergence study with clomazone are provided in the table

below (from Appendix B). In most cases, the NOAEC for phytotoxicity is equivalent to or 

higher than the NOAEC for dry weight or height for the same species. This indicates that

bleaching occurs at levels where effects to dry weight or plant height may also occur. 

NOAEC values for phytotoxicity, dry weight and height. Units are in lbs a.i./A. 

Test species Phytotoxicity Dry Weight Height 

Corn 0.167 0.167 0.37 

Onion 0.0062 0.0062 0.0062 

Ryegrass 0.0185 0.0556 0.0185 

Oat 0.0556 0.167 0.167 

Cucumber 0.5 0.167 0.167 

Soybean >1.5 ≥1.5 0.5 

Carrot 0.0185 0.167 0.0556 

Cabbage 0.0556 0.167 0.167 

Tomato 0.0185 0.0029 0.0185

Lettuce <0.0062 0.0019 0.0009

Page 11 of 35 
7) FL Department of A e Comment: The rial plant toxicity e initially 

designed to determine potential impact to non-target crops and not impacts to native 

vegetation in natural environments. Is EPA co hat the test spec

to derived measurem ints (EC25s and NOECs) adequately represents federally listed 

lant species? Are the measurement endpoints derived from the seedling emergence and 

fects to listed species as the tested species represent a 

taxonomic range of plants which also are commonly found growing wild e.g., legumes, 

ess 

 the 

l 

8)

ew 

 on assumptions, and the relevance of 

the observation to actual clomazone use could not be established. EPA-OPP neglected to 

nges in 

bed 

umbers of incidents to changes in use of the 

esticide since reporting requirements have changed. EPA’s changes in the registrant 

ber of 

Eco

1)

r clomazone and insects. Assumptions about risk that were used in the fomesafen 

ssessment are not applied to the clomazone assessment, and valid data available to the 

e applied inconsistently.” 

gricultur terrest tests wer

nfident t ies (crop plants) used 

ent endpo

p

vegetative vigor studies adequate for determining impacts (survival, reproduction and 

growth) on listed plant species? 

EFED response: The Agency recognizes that terrestrial plant species selected for testing are 

typically annual crop species. While there may be differences in response between crop 

species and native vegetation, these data represent the best available data on surrogate

species for assessing potential ef

grasses etc.). As stated in the Agency’s Overview Document, it is recognized that although 

the endpoints derived from seedling emergence and vegetative vigor studies may not addr

all terrestrial plant life cycle components, it is assumed that impacts at emergence and in

active growth stages have the potential to impact individual competitive ability and 

reproductive success. In cases where a specific mode of action may indicate that typica

testing is insufficient, additional data may be required. 

CLA Comment: “Incident reports were accepted as indicative of ecosystem injury at 

locations far removed from or doubtfully attributed to clomazone application. Very f

incident reports were judged to be definitely associated with clomazone use because 

documentation was incomplete, conclusions were based

relate the declining number of incidents to reduced clomazone exposure based on cha

formulation, labeling and application methods.” 

EFED Response: On p. 64-68 of the ERA, EFED summarized the reported ecological 

incidents for non-target plants that were associated with clomazone. This summary descri

the occurrence of these incidents by formulation, over time and distance from the edge of the 

treated field. It is difficult to attribute declining n

p

reporting requirements for incidents in 1998 likely partially account for a reduced num

reported incidents. Registrants are now only required to submit detailed information on 

‘major’ fish, wildlife, and plant incidents. Minor fish, wildlife, and plant incidents, as well as 

all other non-target incidents, are generally reported aggregately and are not included in 

EIIS. In addition, there have been reductions in state monitoring efforts due to lack of 

resources. 

logical Risks: 

CLA Comment: “The procedures used and the conclusions reached in EPA-OPP’s risk 

assessment do not rectify conflicting information when interpreting the risk assessment

outcomes fo

a

assessment wer

Page 12 of 35 
EFED response: The Agency applied tools that were consistent with current practice an

that were outlined in the Overview Document (USEPA 2004), which has been reviewed by 

the Services and utilizes effects endpoints agreed to by the EPA and the Services in the 

overview document (US EPA, 2004). The 

d 

indirect effects assessment is consistent with the 

verview Document and with current EFED practice. The Agency is currently working on a 

2) d are 

 acreage.” 

y 

3) ational Potato Council (NPC) Comment: “NPC requests that EPA solicit additional outside 

 wind and other climatic conditions greatly reduces the possibility of 

on-target impacts. Any potential impacts from off target applications should be evaluated 

ls 

d in number of species. The agency would welcome 

any additional plant toxicity data that can more closely coincide with listed species or 

ies in 

4)

tive 

O

standardized approach for considering direct effects to terrestrial invertebrates. 

NCC comment: “The document states, ‘Operationally locations where clomazone is use

defined as all cultivated land that has had one or more of the crops for which clomazone is 

registered cultivated on it.’ EPA is digressing to the default assumption of 100% crop treated.

Yet, clomazone use is cotton is estimated to be less than one percent of the cotton

EFED response: In determining the need for mitigation options for clomazone, the Agency 

would welcome and consider additional data that specifies locations of clomazone use in 

fixed areas of cotton growth. Such areas could potentially be used in modifying labels to limit 

the geographic extent of potential use sites for clomazone. 

The Agency does not consider the percentage of crop treated in ecological risk assessments 

because the risks are mostly associated with the occurrence of wildlife near the edge of an

single treated field. 

N

review of the components of the risk assessment model that estimate the quantity and impact

of non-target exposures. The currently available spray equipment coupled with grower’s 

vigilance in watching

n

for actual impacts on particular vegetative species to determine if impacts are long term or 

merely produce short term changes in growth patterns. Over estimating adverse effects of the 

permanence of adverse effects drives mitigation measures and in particular buffers to leve

that make crop production impossible. 

EFED response: The Agency’s thresholds for concern to listed plant species and non-listed

species as a general resource have already been reviewed by the Federal Insecticide 

Fungicide Rodenticide (FIFRA) Science Advisory Panel (SAP). The data set for clomazone, 

regarding indirect plant effects, is limite

species on which listed species depend. Additionally, the intent of the EPA’s risk assessment 

process for pesticides is proactive and is intended to avoid impacts on non-target spec

the first place. Given the large and thriving agricultural industry in the United States of 

which agricultural pesticide usage is an integral part for most crops, evidence suggests that 

mitigation measures are not making crop production impossible. 

FL Dept of Ag Comment: “...we are concerned that the Agency may be overstating risks to 

federally listed threatened and endangered plant species through the use of very conserva

Page 13 of 35 
assumptions concerning the likelihood of exposure and magnitude of effects from direct 

exposure.” 

ction area: 

1)

or 

are expected to be infrequent as indicated by the incident 

information.’ It is difficult to understand why EPA would set an action area based on rare 

le the Agency’s information supports the existing 1,500 foot buffer from 

be 

r the EC 

2) n 

s cognizant of this need and is working with the Services to define a 

rocess that can be 1) consistently applied for registration review and 2) is consistent with 

3)

FED Response: The Agency is evaluating the incident report in light of other evidence. 

 will 

d vertebrate species. This is based on effects data from 

sts using crop plants and on incident data. The incident data shows that most of the 

leaching of plants found in pastures, fence rows, roadways, and residential properties. These 

rudent 

) in 

EFED Response: The Agency will consider the more specific comments provided by the FL 

Dept of Ag in its letter to the Agency (Dated August 19, 2009). The specific comments are 

addressed throughout this memo. 

A

NCC Comment: “EPA is using rare and unusual incident data to establish a two-mile action 

area for clomazone. At the same time, its own document states, ‘Events outside 1,500 feet f

the EC, WP and ME formulations 

events whi

residential areas and 300 foot buffer from desirable plants.”

EFED Response: Although incidents to non-target plants located outside 1500 feet may be 

rare, effects to plants located 1500 feet to 2 miles from the edge of the treated field cannot 

precluded. EFED set the action area to 1 mile for the ME formulation and 2 miles fo

and WP formulations. 

CLA Comment: “A reasonable and defensible method for determining and describing “actio

area” needs to be guided by a clear Standard Operating Procedure”

EFED Response: EPA i

p

the Services regulations. The Agency is also bringing this issue to the National Academy of 

Sciences for consideration. 

CLA comment: “For both the clomazone and fomesafen assessment, the action area is 

overstated. The basis of the action area for clomazone is a single incident report of 

questionable relevance.”

E

4) Florida Department of Agriculture Comment: “The Agency assumes that clomazone

impact critical habitat for certain liste

te

clomazone incidents occur within 300 feet from treated fields and consist of off-field 

b

areas are typically considered to be open or semi-open canopy environments that do not 

represent many native plant communities. In addition, areas around crops, particularly within

300 feet, are disturbed areas that are in constant transition due to, not only chemical 

exposure, but from mechanical disturbance of both plants and soil. While it would be p

to assume that for species that rely on these disturbed, transition zones (e.g., Monarch 

butterflies, bobwhite quail) may be impacted from habitat alteration (killing of vegetation

these habitat zones it is not appropriate to assume that these areas [those within 300 ft of 

Page 14 of 35 
EOF] would be utilized by listed species that are ‘reliant or obligate on limited numb

plant species, a habitat that is dominated by a few species (e.g., prairie grassland), have small 

localized populations, or are highly reliant on camouflage during late May through late

This is the description that the Agency uses to identify species they assume to be likely 

indirectly impacted by the used of clomazone. However, we would argue that the species 

most likely indirectly impacted would be those that utilize (either for food or cover) disturb

habitat within 300 feet of crop margins. This would result in a much narrower and realistic 

list of species potentially impacted.”

EFED Response: Evaluation of presence or absence of a listed species within areas impac

by clomazone toxicity to vegetation involves consideration of each species’ habitat 

requirements and the availability of those requirements within predicted impact areas. EFE

will consider the Florida Department

er of 

 July.’ 

ed 

ted 

D 

 of Agriculture’s species specific comments that were 

provided in the August 19, 2009 letter submitted to the Agency. 

Lis

1)

s where spatial data demonstrated a species existed 

FED Response: The clomazone assessment used an innovative “proximity analysis,” that 

ed 

May Affect” situations 

ere thus limited to species whose locations (EOs) were within the “effect area” of 1 or 2 

2) s: “In 

, 

y 

d and affected by the uses of these pesticides. While the fomesafen assessment 

sed standard geographical tools refined with expanded biological characteristics, the 

ted Species Effects Determinations: 

CLA Comment: “Species have been assigned ‘may affect’ determinations in many instances 

where there is no geographic proximity, or where other clear and significant factors exclude

being of concern.” 

FESTF Comment: “In several instance

only outside of the action area, EFED incorrectly concluded a ‘may affect’ determination 

despite spatial relationships indicated no exposure would occur.” 

E

incorporated Element Occurrence (EO) data from NatureServe and maps of cropped land 

from the National Land Cover Database (NLCD) to determine the distance between observ

locations of listed species and the clomazone use area. Potential “

w

miles from the edge of cropped land. This assessment did consider significant factors related

to types of listed species that would lead to Not Likely to Adversely Affect (NLAA) 

determinations. For example, in cases where clomazone may affect some listed species based 

on spatial overlap of use areas (and the 1-2 mile buffer) and species EO, NLAA 

determinations were made for large land birds, mammals and reptiles not known to be 

reliant on one or a limited number of non-listed or listed terrestrial or semi-aquatic plant 

species. 

CLA Comment: In its introduction to the EFED draft risk assessment5

, EPA note

conducting these first two national listed species assessments and effects determinations

EPA explored effective and efficient methods of identifying the universe of species that ma

be expose

u

 

5

 U.S. Environmental Protection Agency (EPA). 2009. Letter from Arthur-Jean B. Williams, Associate Director 

Environmental Fate and Effects Division (7507P) to Bryan Arroyo, Assistant Director for Endangered Species 

(USFWS) and James Lecky, Director (NMFS). April 22, 2009 and EPA-OPP Fact Sheet at 

http://www.epa.gov/oppsrrd1/REDs/factsheets/clomazone-fomesafen-fs.html. 

Page 15 of 35 
clomazone assessment used refined geographical proximity analyses in determining what 

species might and might not be exposed to the pesticide at levels of concern.” Such a 

description is cursory and incorrect, because it is arguable whether the fomesafen asses

employed “geographical tools refined with expanded biological characteristics” nor should

the clomazone assessment have ended with “geographical proximity analyses” that add

only a fraction of the data available to EPA for the assessment.” 

EFED Response: The fomesafen assessment used the standard geographical tool in routine 

use at EPA for species location, the LOCATES database, which in

sment 

ressed 

dicates species presence 

on a county-level basis. As noted above, the clomazone assessment used an innovative 

fine 

rvices. 

3) esafen 

“process.” However, the stated methods were not completely adhered to in the actual 

sments under Registration Review. As EPA works to complete other 

assessments under Registration Review, we will continue to explore other methods as well as 

4)

e, communication late in the process of Registration 

Review resulted in EPA-OPP allowing insufficient time to assimilate and understand the 

“proximity analysis,” that relied upon EO data from NatureServe and maps of cropped land

from the NLCD to determine the distance between observed locations of listed species and 

the clomazone use area. Potential “May Affect” situations were thus limited to species 

whose locations (EOs) were within the “effect area” of 1 or 2 miles from the edge of cropped

land. This allowed for finer resolution of “May Affect” calls than the county-level 

LOCATES database would support. It is EPA’s intent to use biological information to re

effect determinations routinely in the future, however at the time of the assessment, a 

comprehensive database of relevant biological factors was not available from the Se

CLA Comment: “The stated basis of the effects determination for clomazone and fom

were admitted by EPA-OPP to be different, intended as a way to explore and define 

assessment and deserve further consideration so that a definitive and predictable process can 

be established.” 

EFED Response: This assessment was one of two “pilot” assessments exploring processes 

to complete asses

refine and improve our process. 

CLA Comment: “As we have noted, in the current cases, EPA-OPP did not fully utilize the 

data available to it. For clomazon

extremely useful yet logistically overwhelming data presented to the Agency by the 

registrant’s data submission using FESTF data6

. Reliance on such data in the case of 

clomazone would have provided: 

a) A current and comprehensive, robustly documented and quality tested, tabulation of 

listed species and critical habitat. EPA-OPP’s assessment included species that are not 

federally listed by ESA, omitted species that are listed by ESA, and missed certain details 

related to species for which listing status or specifics have changed. Inclusion of certain 

species in the EPA-OPP assessment did not follow the procedural guidance of the 

 

6

 Frank AR. 2009. Clomazone: analysis of potential direct and indirect effects on threatened and endangered species. 

January 13, 2009. FIFRA Endangered Species Task Force (FESTF), Washington, DC and FMC Corporation, 

Princeton, NJ. MRID 4764701. 

Page 16 of 35 
Services and ESA because they did not access the most current information and speci

details available to them in the FESTF/FMC data.” 

EFED response: EPA recognizes the value of current, comprehensive species listing and

critical habitat information in effects determinations, and looks forward to working

the Services and FESTF to develop Services-approved data sources for routine use. 

es 

 with 

b) A comprehensive biological evaluation using all available information on species 

locations, proximity to crops of interest, and species and habitat attributes. EPA-OPP’s 

reliance solely on proximity data addressed only a small portion of the species and crop 

interactions that are presented by the assessment itself. By using FESTF and registrantsubmitted data, up to 90% of these interactions can be assessed at the national level, 

n or 

l 

y 

y the Services), as well as geographic factors. EPA looks 

forward to working with the Services to develop a database of relevant biological factors 

c)

leaving only a small fraction of obscure or little understood species for consultatio

more intensive analysis.” 

EFED response: EPA recognizes the value of current, comprehensive data on biologica

parameters useful in effect determinations (juvenile and adult body weights, diet, 

metabolic rates, ecological data such as obligate relationships between species, and an

others deemed necessary b

that is acceptable for use in effect determinations. Again, presentation of data in GIS 

format, wherever possible, would be most useful. 

A reduced subset of species requiring comprehensive analysis based on a current 

portrayal of co-occurrence between species locations and potential clomazone use site(s).

For example, from a universe of possible species or concern of 1360 species, EFED 

assessed 1064 species for wet and/or dry seeded rice, while with the benefit of more 

current and comprehensive data, the FESTF/FMC assessment demonstrated that it was 

strated 

ot 

n 

)

necessary only to address 296 species. The reason for this difference can be demon

by example using the data for the ash-grey paintbrush (Castilleja cinerea), which was 

assessed by EFED for rice uses (both wet seeded and dry seeded). This species was n

assessed in the FESTF/FMC assessment because it only occurs in San Bernardino 

County, California which is not a reported rice growing county or adjacent to any rick 

growing counties.” 

EFED Response: For determining co-occurrence with listed species and clomazone use 

on rice, EFED will consider available data on areas where rice is historically grow

(e.g., NASS). 

d Assurance that species included in the assessment follow the procedural guidance of the 

Services and ESA. EPA-OPP did not access the most current information and species 

details available to them in the FESTF/FMC data.” 

EFED response: The meaning of this comment is not entirely clear. As stated above, 

EPA intends to work with the Services to make the most up-to-date data available for 

routine use. If the comment is a reference to use of data presented in the FESTF IMS, 

Page 17 of 35 
EPA reiterates its request that the data be presented not in text format, but in a more 

comprehensible format such as GIS whenever possible. 

e) A closer concurrence with data available to state FIFRA enforcement and Services 

offices. Overlooking much of the information (spatial and biological) available in the 

FESTF IMS and FMC species assessment that could be used to support effects 

determinations resulted in erroneous conclusions about species exposure and greatly 

expanded the consultation request. For example, the comment to the docket provided b

North Dakota, when compared to the conclusions reache

y 

d by FESTF/FMC and those 

reached by EPA-OPP, further supports the findings of the FESTF/FMC assessment rather 

rmat and 

than those of EPA-OPP.” 

EFED response: Data from field offices and states can be problematic due to fo

documentation issues between different data submitters. That being said, if species 

location data such as presented by North Dakota meet EPA’s standards, these data will 

be incorporated into the risk assessment process. 

f) A more complete and scientific approach, allowing for EPA-OPP’s assessments to be 

refined and to focus in on the species with greater potential for exposure, and thus also 

focusing the scope of and efficiency of consultation, if required. The IMS assessment 

provided EPA with information on species habitat, diet, proximity to potential clomazone 

use sites, locations of reported use sites, statements from species experts, and many other

types of information that are extremely important to the identification of potentially 

affected species during the national-level endangered species assessment process.” 

s 

rse 

fficial 

critical habitat maps) from subjective information (e.g., outside expert opinion) and 

5) ND

reg

mu

occ ary 

bur r 

the 

ion 

EFED response: EPA appreciates CropLife America’s efforts to provide relevant data 

for species effect determinations. As stated elsewhere in EPA’s responses to comment

on the clomazone risk assessment, the utility of such data would be greatly enhanced by 

presentation in a format (GIS) that enables comprehensive spatial analysis wherever 

possible. The concurrence of the Services on the quality of any data sources is of cou

indispensible. To that end, the separation of objective information (e.g., Services’ o

poorly documented information (e.g., information taken from reports in draft form) in 

FESTF submissions would be very helpful. 

 Department of Agriculture Comment: “Endangered species locations used in the 

istration review are at the county-wide level, although many agencies including ours have 

ch more precise maps of endangered species occurrences including locations of individual 

urrences. Using refined data would better protect listed species and prevent unnecess

den to pesticide users. We have given an example of the difference this can make unde

western prairie fringed orchid section.” 

EFED Response: The U.S. Fish and Wildlife Service (USFWS) provides species locat

information at the county-level on their endangered species website. Furthermore, 

EPA/OPP’s Endangered Species Protection Program (ESPP) generates bulletins with 

enforceable pesticide use limitations on a county-level basis. That said, if species location 

Page 18 of 35 
data provided by North Dakota’s Department of Agriculture or other agencies meet EPA’s 

standards, these data will be incorporated into the risk assessment process.

6)

e the 

 data 

The satellite used for remote sensing is A WiFS that is on the Resourcesat-1 satellite, run by 

ot 

 and 

ad two robust data sources to build the Cropland Data Layer (CDL). The A WiFS 

agery continuously comes into our system as well as the CLU data so that they are making 

l 

etadata from the survey is downloadable at 

7) D Department of Agriculture comment: “Below we present data and maps on endangered 

d for use in North Dakota. We believe this 

orth Dakota and is much 

etter than the location data used in the registration review, which was only refined to a 

ND Department of Agriculture Comment: Crop use locations data in the registration review

document is from USDA’s 2002 census of agriculture. We recommend that EPA us

more recently released USDA National Agriculture Statistics Service (NASS) Cropland

layer issued in March of 2009 for most states. The data is from remote sensing based 

cropland acreage indications and verified with on the ground surveys. 

the Indian Government. The satellite’s resolution is 56 meters, or 0.77 acres; it covers the 

same area approximately every 5 days. NASS collects A WiFS data year round and may n

need to supplement their program with MODIS. A WiFS has two cameras, each has with a 

swath width of 340 KM, combined it covers 740 KM, the bands are green, red, near-IR

sw-IR. 

USDA/Farm Service Agency/Common Land Unit data is used for training our classifier in 

the agriculture domain and uses USGS/NLCD 2001 dataset to train over the non-agriculture

domain. NASS uses a software combination of ArcGIS for ground truth editing, ERDAS 

Imagine and See5 for image processing, and SAS IML workshop for estimation. 

NASS h

im

classifications with the more recent up to date dataset. The CDL is built annually and has 

been re-engineered within the last few years. Previously, Landsat imagery was used, June 

Ag Survey data for training data, and in-house software for image classification purposes. 

The latest CDL product for crop year 2008 will be available March 1. 

The regression estimation uses not only data from the sensor but also data from the Nationa

June Agriculture Survey. The June Agriculture Survey data is used for building regression 

models and estimating acreage. During the survey 41,000 farms are contacted and 11,000 

one square mile sample area segments are visited. The information provided by NASS is 

county and state level “major crops”. 

M

http://www.nass.usda.gov/research/Cropland/metadata/meta.ht” 

EFED Response: The proximity analysis from FESTF used NASS data. The Agency is 

exploring the utility of CDL for use in proximity analyses. 

N

species and areas in which clomazone is labele

data is the best available information for endangered species in N

b

county-wide level. We realize that before this data can be used by the EPA the quality 

Page 19 of 35 
control measures and sources will have to be examined by EPA. We have listed our sources 

o 

or 

f 

8)

EFED Response: EPA appreciates the North Dakota Department of Agriculture’s efforts to 

e 

rocess. 

9)

that EPA must look at more 

etailed data before using this registration review to impose clomazone restrictions in North 

ate 

or example, in Richland County of North Dakota, western prairie fringed orchids 

re found in the eastern one-fourth of the county. Most areas of the county are not found 

other 

10)

location data for endangered species before setting any use restrictions or mitigation for 

for the data used below and all of the data available in Appendix A.” 

EFED Response: EPA appreciates the North Dakota Department of Agriculture’s efforts t

present data and maps on endangered species and areas in which clomazone is labeled f

use in North Dakota. If species location data provided by North Dakota’s Department o

Agriculture or other agencies meet EPA’s standards, these data will be incorporated into the 

risk assessment process. 

ND Department of Agriculture comment: “Our state has collected many sets of data in GIS 

that we offer for EPA’s consideration as the Agency assesses risk to listed species. We can 

also provide specific data sets upon EPA request, including state cropping data, soil maps,

pesticide use and environmental monitoring data.” 

provide data for EPA’s consideration. EFED recommends that PRD request that the ND 

Department of Agriculture provide the data discussed in their comment. If the data provided

by North Dakota’s Department of Agriculture or other agencies meet EPA’s standards, thes

data will be incorporated into the risk assessment p

ND Department of Agriculture comment: “The western prairie fringed orchid is the only 

listed species in North Dakota where there is an appreciable risk of clomazone causing 

adverse effects. However, the distribution of orchids is extremely limited, and most orchids 

occur in native prairie or undisturbed areas in parts of Ransom and Richland Counties in the 

southeast part of the state. For this reason, we feel strongly 

d

Dakota.” 

The data used in the registration review is only refined to a county-wide level, however many

agencies including ours have GIS or other geographical locations of all of the individual 

occurrences of western prairie fringed orchids. Using this type of data would help elimin

unreasonable burdens to pesticide users in these areas while still protecting endangered 

species. F

a

within two miles of western prairie fringed orchids, so to list all of Richland county as having 

and endangered monocot, as shown on page 394 in appendix I is not accurate (figure 1).”

EFED Response: If the data provided by North Dakota’s Department of Agriculture or 

agencies meet EPA’s standards, these data will be incorporated into the risk assessment 

process. 

ND Department of Agriculture comment: “Most importantly, EPA should use more refined

listed species.” 

Page 20 of 35 
EFED Response: EPA would be happy to use more refined location data for endangered 

11) ESTF comment: “Given further interaction and exposure to FESTF data and member 

he 

er than using just a small portion of that data as was done in its 

ndangered species effects determination on clomazone. Use of FESTF data and member 

ions 

k, 

ill 

 for a 

rehensive analysis of species proximity and biology specifically 

developed by the registrant to aid in EPA-OPP’s effects determination was submitted. 

and 

ies. It is 

tailed 

 the 

d 

ad 

developed to aid in EPA-OPP’s effects 

determination on that product. CLA understands the challenges EPA-OPP faced in 

e for a 

 to 

 

species assuming that these meet EPA’s standards, these data will be incorporated into the 

risk assessment process.

F

assessments, FESTF fully expects that EPA will find utility and efficiency by using all of t

species data provided to it through any assessment utilizing the FESTF’s Information 

Management System, rath

e

assessments will strengthen the “No Effect” and “Not Likely to Adversely Affect” decis

EPA-OPP makes, while greatly reducing the number of ‘May Affect’ conditions that might 

exist, thereby consolidating the burden of consultation to only those species having a 

reasonable expectation of exposure to levels of a given pesticide that present a potential ris

in specific local areas wherein that potential risk is not mitigated by standard labeling. It w

be important to deliver these data in a manner expediting their use, but to do so registrants 

need to better understand how they can interact with EPA both during the Registration 

Review process and in the ESA consultation process. In this way, registrants can plan

timely data submission and understand EPA’s primary concerns about and need for 

supporting data.” 

FESTF Comment: “For both the clomazone and fomesafen assessments, EPA-OPP had

available to it FESTF-submitted data on species locations, species biology, and the proximity

of species to crops of interest through previous FESTF submissions. In the case of 

clomazone, a comp

FESTF appreciates the challenges EPA-OPP faced in attempting to assimilate this vast 

amount of data over the short period of time available to it for a national-level endangered 

species assessment, and seeks to continue to work with EPA to support their use of 

access to the best available data as provided through FESTF and its member compan

in the interest of furthering FESTF’s data use and understanding its benefits that the de

comments below are offered on clomazone. The same general observations will apply to

fomesafen evaluation given EPA’s future access to a similarly robust species data 

compilation. For specific details to enhance the EPA-OPP assessments on clomazone an

fomesafen, please see the detailed information about species data as reviewed in their 

individual responses to the case dockets.7

CLA Comment: “For both the clomazone and fomesafen assessments, EPA-OPP h

available FESTF-submitted data on species locations, species biology, the proximity of 

species to crops of interest, and, in the case of clomazone, a comprehensive analysis of

species proximity and biology specifically 

attempting to assimilate this vast amount of data over the short period of time availabl

national-level endangered species assessment. CLA seeks to continue to work with EPA

7

 Responsive comments to clomazone, by FMC, and fomesafen, by Syngenta, to the respective case dockets EPAHQ-OPP-2006-0113 and EPA-HQ-OPP-2006-0239, August 2009. 

Page 21 of 35 
support its access to and use of the best available data in its assessment of endanger

effects.” 

EFED Response: EPA appreciates FESTF’s efforts to provide data on species locations, 

proximity to cropped land, and species biology in support of listed species effect 

determina

ed species 

tions. EFED did not use these data because of concerns over the quality and 

format of these data. EPA has previously commented on variable quality and documentation 

ey 

mat, 

he data 

s (in the 

isted 

12)

al 

tions 

that it answered for FESTF early in FESTF’s development stages. In developing data for 

o 

: 

 

of the FESTF IMS (Information Management System) data. In addition, the presentation 

format of data from the FESTF IMS makes the data impractical to use because th

presented on an element occurrence (EO)-by-EO basis, county by county, and in text for

making the data difficult to interpret in a holistic manner. In order to comprehend the data 

throughout the range of a species, and not make contradictory determinations when 

individual EOs are considered in isolation, it is necessary to display and manipulate t

for all EOs simultaneously. This would best be done by presenting the data in GIS 

(geographic information system) format, allowing the EPA scientist to comprehend the 

relationship of species range (including critical habitat) to relevant land cover classe

case of clomazone, cultivated land), and to geographic factors (e.g., elevation) that may be 

mitigating factors. It would be EPA’s preference that data submissions relevant to l

species determinations are presented in GIS-compatible format whenever possible.

FESTF comment: “Interestingly, in approaching the two assessments on clomazone and 

fomesafen as “pilots” to test processes based generally on biological (fomesafen) and spati

(clomazone) approaches, EPA is addressing through the now-emerging process ques

EPA-OPP on endangered species to address the requirements of PR Notice 2000-2, EPAOPP strongly advised that getting species not likely to be exposed to a given use “off the 

table” was an important predecessor to more time consuming refined risk assessment. In 

fact, in an early feasibility study on the use of spatial data for species assessment, 8

 FESTF

learned (and EPA later concurred9) that spatial data alone was not a satisfactory solution t

species evaluation. One objective in species assessment is to address the “easy outs” first

those species or species groups that can be eliminated from concern en masse due to some

attribute clearly factually based and free of multiple assumptions about exposure and risk. 

However, lack of process is inhibiting consensus: clear guidance on data sources and 

approaches needs to be developed because inevitably there will be differences in scientific 

opinion that are only compounded when the underlying structure is unclear. Those 

differences are much harder to assess and resolve if methodology is inconsistent and not 

driven by transparent processes and clear policy.” 

8 A proposal to satisfy EPA requirements for Endangered Species data related to pesticide use and feasibility project 

report. Submitted to the Environmental Protection Agency on June 28, 1996. 9 Review of Status and Summary of Proposal: A Description of FIFRA Endangered Species Take Force Work 

Product in the Context of the OPP Endangered Species Protection Program. An overview document jointly 

prepared by participants in the EPA/OPP Endangered Species Pesticide Program and the FIFRA Endangered 

Species Task Force. Letter from Bernalyn McGaughey, for FESTF Technical Administrative Chairs to Arthur-Jean 

Williams, Branch Chief, EFB. July 1, 1997. 

Page 22 of 35 
EFED Response: This assessment was one of two “pilot” assessments exploring process

to complete assessments under Registration Review

es 

. Although the Agency explored new 

methods, both of which were considered to be reasonable and protective measures of risk, 

13) nce 

zone action area. However, there are 

any species locations considered in EFED’s assessment that are not included in the FESTF 

7 species to be evaluated rather 

an EPA’s 1360 identified species. EPA’s higher number was a result of erroneously 

d 1064 species to be assessed while the IMS correctly identified 296 species. EPA’s 

greater number of species was again due largely to inclusion of species for which there was 

n EFED’s inclusion of a number of 

ecies as ‘may affects’ that would have been eliminated from concern where these factors 

 or 

s. However, EFED does not agree with the comment that the spatial 

nd biological information included in the FESTF IMS was not used in the clomazone risk 

 

both of these assessments are consistent with scientific procedures outlined in the Agency’s 

Ecological Risk Assessment Process10, which is EFED’s current practice for conducting 

ecological risk assessments and effects determinations for pesticides. As EPA works to 

complete other assessments under Registration Review we will continue to explore other 

methods as well as refine and improve our process. 

FESTF Comment: “EPA’s assessment cited the use of the IMS to evaluate the co-occurre

of listed species and critical habitat within the cloma

m

IMS due to lack of co-occurrence between species locations and potential clomazone use 

sites. Moreover, much of the information (spatial and biological) available in the FESTF 

IMS that could be used to support effects determinations was not utilized by EFED, largely 

due to resource limitations and lack of familiarity with the tools... FESTF is willing... to 

assist EPA in understanding and utilizing these tools...” 

FESTF Comment: “In initially setting up the FESTF/FMC assessment, a more precise list of 

species was generated using the IMS by starting with 116

th

including species that did not co-occur with or have an adjacency to crops on the clomazone 

label.” 

FESTF Comment: “In setting up the assessments for rice, EPA’s assessment erroneously 

identifie

no co-occurrence with the crop under evaluation.” 

FESTF Comment: “Reliance on spatial data and only cursory attention to species attributes 

(habitat, diet and other biological factors) resulted i

sp

(presented in FMC IMS data) assessed by EFED. Examples of co-occurrences that can be 

eliminated from concern based on these considerations include species that are dormant

not present in a particular county when clomazone is applied, species that do not have direct

effect concerns and are not reliant on a limited number of plant species for cover, diet, or 

other processes, and various other habitat characteristics and use site conditions that would 

preclude exposure.” 

EFED Response: EPA appreciates FESTF’s offer to assist EPA in understanding and 

utilizing the IMS tool

a

10 USEPA. 2004. Overview of the ecological risk assessment process in the Office of Pesticide Programs, U.S. 

Environmental Protection Agency. Endangered and Threatened Species Effects Determinations. United States 

Environmental Protection Agency, Office of Pesticide Programs. Available online at: 

http://www.epa.gov/espp/consultation/ecorisk-overview.pdf. 

Page 23 of 35 
assessment “... due to resource limitations and lack of familiarity with the tools.” EPA

previously commented on FESTF IMS (Information Management System) data quality 

documentation issues. Data in IMS are of variable quality and documentation, and, the 

spatial data as presented (in text format on an EO-by-EO basis) are very difficult to use. 

EPA will, to the extent practical, incorporate IMS data into the revised assessment for 

clomazone. 

FESTF comment: “The additional data that was assimilated in the FESTF/FMC assessm

but not in the 

 has 

14) ent, 

EFED assessment, are soundly documented data, largely from the Services, 

that justify changing many (as much as 90%) of EPA’s “may affect” determinations to no 

t 

e of variable quality and 

ocumentation and, as presented (in text format on an EO-by-EO basis) are very difficult to 

dgment 

15)

able data for use in 

species assessment, resulted in inclusion of many species that have no proximal relationship 

cies for 

y 

determination from indirect effects for all listed aquatic 

ecies. Many of these species would have been eliminated from concern had the full set of 

the site within which effects above 

the Level of Concern are expected to occur. The effect area is determined by the extent of 

 And, 

nner. 

effects” or “not likely to adversely affect” determinations. 

EFED response: EPA has previously commented on FESTF IMS (Information Managemen

System) data quality documentation issues. Data in IMS ar

d

use in a comprehensive effect determination. EPA will, to the extent practical, incorporate 

IMS data into the revised assessment for clomazone. However, EPA must reserve ju

about specific effect determinations until the data can be re-examined. 

FESTF Comment: “EFED’s heavy reliance on spatial data without consulting other 

geographical or agronomic data, which together represent the best avail

or behavioral exposure to clomazone use. For example, many of the Florida plant spe

which a “may affect” was determined for rice use are on the Lake Wales ridge, a xeric sand

upland well away from and well above rice growing locations. The FMC clomazone 

assessment captured these details and reported information that would likely have changed 

many of EPA’s ‘may affect’ determinations to lesser affect status, thus avoiding unnecessary 

consultation requirements.” 

FESTF Comment: “Omission of data from EPA’s assessment, but provided in FMC’s 

assessment, resulted in a ‘may affect’ 

sp

FESTF and FMC data been considered. For example, species elevation and information

regarding mountain ranges between potential clomazone use sites and species locations were 

included in the IMS assessment. These were available and frequently provide a basis for an 

EFED effects determination of less than ‘may affect.’” 

EFED response: EPA used spatial data in its effect determinations because the “effect area”

around pesticide use sites is based on the distance from 

spray drift, downstream dilution, and in the case of clomazone, volatilization and redeposition to terrestrial ecosystems. Based on the lack of proximity information between 

species locations and cropped land in Guam, the Marianas, and other U.S. territories, 

adverse effects could not be ruled out based on species being outside the effect area. 

as mentioned before, the manner of presentation of IMS data makes it impractical in many 

cases to use it in a holistic manner in effect determinations in a nationally consistent ma

Page 24 of 35 
16)

through the IMS, to non-rice crops on the label.” 

idered. 

17)

ent due to the data management 

aspects available to the IMS user.” 

ltiple listings for the same species. 

18)

pecies are 

ocumented as no longer found in given areas and thus not subject to clomazone exposure. 

 U.S. 

nger listed and add any species that have been listed since the ERA was completed. 

In terms of species with modified spatial locations, those locations will be considered during 

19)

ses been misunderstood or misapplied to EPA’s assessment.” 

r more use sites 

at the state level. This means that if one species location (regardless of geography) in any 

se 

ssessment. The 

istance between the species and the use site can be estimated based on the biological or 

ce 

FESTF Comment: “In setting up the assessments for non-rice uses, EPA failed to include 

two species that should have been evaluated based on their potential adjacency, as identified 

EFED response: EFED would like to request clarification from FESTF as to the specific 

names of the two listed species that were not cons

FESTF Comment: “The EPA assessment considers some species more than once whereas

the same species is counted only once in the IMS assessm

EFED response: EFED’s assessment considers each listing for endangered and threatened

species. In some cases, there are mu

FESTF Comment: “In some cases, EFED failed to note that a species had been delisted and 

an effects determination was thus no longer necessary. Similarly, some s

d

EPA-OPP did not access such information for their assessment. References are available in 

the FESTF IMS to support this information and are consistent with data found in the

Fish and Wildlife’s Species Profiles, and full references are provided and uploaded to the 

IMS so that such information can be verified by EPA or the Services should they choose to 

do so.” 

EFED response: When the ERA for clomazone is revised, EFED will consider which species

are no lo

consultation. 

FESTF Comment: Spatial proximity data generated using FESTF multi-jurisdictional data 

has in some ca

“It appears that effect determinations were assigned in the EFED assessment on a species 

basis and the only indication of location was overlap of the species with one o

state was determined to be inside of the action area, every state where that species was 

known to occur was identified as overlapping with one or more use site.” 

“Some species co-occurrences may be excluded due to lack of proximity to clomazone u

sites within a county, but this consideration was not applied to the EFED a

d

spatial data in the FESTF MJD coupled with subcounty information on crop locations from 

land use data (NLCD, class 82, a classification which still gives a conservative analysis sin

this land class is used for all row crops, not just those on the clomazone label).” 

Page 25 of 35 
EFED Response: As indicated above, the clomazone assessment used EO data from 

NatureServe and maps of cropped land from the National Land Cover Database (NLCD) to 

determine the distance between observed locations of listed species and the clomazone use 

 to 

20)

his means that overlap in the action area was assumed even if there were no 

labeled crops in the county examined. An association was assumed based solely upon the 

ce 

al 

future use (e.g., conversion of CRP land to cultivated cropland) of pesticides used in 

s 

21) gnated 

area (including future use sites). Potential “May Affect” situations were thus limited

species whose locations (EOs) were within the “effect area” of 1 or 2 miles from the edge of 

cropped land. 

FESTF Comment: “There is no distinction between proximity of species locations to various 

non-rice uses. T

species locations being found to be in proximity to NLCD class 82 (agricultural lands).” 

EFED Response: The NLCD data are currently the best available national-level data sour

for potential agricultural pesticide use sites. Additionally, in order to account for potenti

agriculture, OPP currently assumes that all of the cultivated cropland within the NLCD class 

82 represents the potential use sites. OPP is, however, exploring additional data resources 

that may allow for the refinement of potential use sites. For example, the United State

Department of Agriculture (USDA) National Agricultural Statistics Service (NASS) is 

developing cropland data layers that represent individual crops. These data are currently 

only available for selected states. When these become available nationally, OPP will 

consider how they may be used in place of the generalized NLCD data. 

FESTF Comment: “EFED erroneously reported that 87 listed species did not have desi

critical habitat when in fact they do.” 

EFED response: EFED agrees that it erroneously reported that several listed species did not 

have designated critical habitat when this is not the case. For example, EFED reported that 

the frosted flatwoods salamander (Ambystoma cingulatum) and the arroyo toad (Bufo 

californicus) do not have designated critical habitat when this is not the case. EFED will 

review all species listed in the ERA as not having designated critical habitats and correct 

any errors in cases when final designated critical habitats are established. 

The North Dakota Department of Agriculture indicated that “There are seven threatened or

endangered species in North Dakota, the interior least tern (Sterna antillaru

22)

m), whooping 

crane (Grus americana), pallid sturgeon (Scaphirhynchus albus), black-footed ferret 

d ferret and whooping crane), we 

isagree with your final assessment of likely to adversely affect.” 

ct effects to mammals are 

ot likely to adversely affect and that indirect effects to small and to large carnivores would 

(Mustela nigripes), gray wolf (Canis lupus), piping plover (Charadrius melodus), and the 

western prairie fringed orchid (Platanthera praeclara).” 

And that: “We agree with most of your risk assessments for endangered species in North 

Dakota. However, for two endangered species (black foote

d

Regarding the black footed ferret, North Dakota Department of Agriculture stated: “Table 47

[of the risk assessment] states that at rates above 0.75 lbs ai/A, dire

n

Page 26 of 35 
not be likely to adversely affect. Black footed ferrets are carnivores, so we believe that 

clomazone is not likely to adversely affect black footed ferrets...Furthermore, despite 

extensive search efforts, the last black footed ferret sighting in North Dakota was in 1970.” 

EFED response: In the ERA, the effects determination for small to large carnivores is N

rice uses of clomazone. For non-rice uses of clomazone, the effects determination for small 

E for 

to large carnivores is NLAA; however, for species which live in “a habitat that is dominated 

the 

4 

 or are 

 species during their migration through North Dakota. 

hooping cranes stop at different locations during each migration, so if a location has a 

x 

by a few species (e.g., prairie grassland), have small localized populations, or are highly 

reliant on camouflage during late May through late July may potentially be indirectly 

affected from impacts to vegetation,” the effects determination is LAA (Table 47 of ERA). 

Since black-footed ferret primarily consumes prairie dogs11, EFED agrees that the blackfooted ferret is a carnivore. According to the US Fish and Wildlife Service's profile for 

black-footed ferret12, this species is "well adapted to its prairie environment. Its color and 

markings blend so well with grassland soils and plants, that it is hard to detect until it 

moves." Also, as of 2010, approximately 700 free ranging adults exist in the wild, with only 

populations with at least 30 breeding adults. 13 Based on this information, the effects 

determination for non-rice uses of clomazone is LAA due to potential indirect effects 

resulting from effects to vegetation. 

The North Dakota Department of Agriculture stated: “Whooping cranes do not rely on

obligate to a limited number of plant

W

subpar habitat, the whooping cranes could easily fly to a better foraging or roosting area. For 

this reason we believe indirect effects to whooping cranes in North Dakota should be not 

likely to adversely affect, instead of the likely to adversely affect that is listed in Appendi

I.” 

EFED response: Originally, an LAA effects determination was made for the whooping crane due 

to potential indirect effects of clomazone through effects to vegetation because this species has 

“small localized populations.” According to the US Fish and Wildlife Service14: 

- there are approximately 383 individual whooping cranes in the wild, with “only one selfsustaining wild population, the Aransas-Wood Buffalo National Park population, which 

nests in Wood Buffalo National Park and adjacent areas in Canada, and winters in 

coastal marshes in Texas at Aransas. In addition, there is a small captive-raised, nonmigratory population in central Florida, and a small migratory population of individuals

introduced beginning in 2001 that migrate between Wisconsin and Florida in an eastern 

migratory population.” 

- “During migration, whooping cranes use a variety of habitats; however wetland mosaics 

appear to be the most suitable. For feeding, whooping cranes primarily use shallow, 

seasonally and semi permanently flooded palustrine wetlands for roosting, and various 

cropland and emergent wetlands.” 

 

11 Hillman, C.N. and T.W. Clark. 1980. Mustela nigripes. Mammalian Species (Publication of the American Society 

of Mammalogists), No. 126, p. 1-3. 

12 http://ecos.fws.gov/speciesProfile/profile/speciesProfile.action?spcode=A004 13 http://www.fws.gov/mountain-prairie/species/mammals/blackfootedferret/ 14 http://ecos.fws.gov/speciesProfile/profile/speciesProfile.action?spcode=B003 

Page 27 of 35 
- Groups of whooping cranes may have traditional stopover sites during migration15. 

Based on this information, impacts to the habitat of this species, in particular in tradition

stopover sites, are considered Likely to Adversely Affect the species during migration. 

al 

t 

use 

and preferably, if available, sub-county spatial data for both land use or species locations.” 

24)

 to pose a threat. Wetland exposure 

ssessment greatly overestimates risk.” 

25)

xtirpated from Florida and likely extinct.” 

an’s 

26)

rida and likely extinct.” Also because 

Habitat (old growth bald cypress) not likely within 1,500 feet of fields.” 

ecies should be 

odified to NLAA. 

27)

uent visitor to South Florida. They are not dependent on habitat in 

lorida.” 

 

23) Florida Department of Agriculture Comment:“Lastly, we feel that the Agency has not ye

refined the endangered species assessment adequately using, at a minimum, descriptive 

characterization of the species locations or habitat requirements in relation to crop/land 

EFED Response: EPA will consider using more refined location data for endangered 

species as well as sub-county spatial data for both land use and species locations assuming 

that these data are available and meet EPA’s standards. 

The Florida Department of Agriculture indicated that EPA should consider a NLAA 

determination for the Whooping crane for non-rice uses of clomazone due to “Large home 

range; limited habitat damage adjacent to fields not likely

a

EFED response: As indicated above, for locations where the whooping crane resides during

winter and summer (i.e., Florida and Texas), the effects determination for this species will 

remain LAA. 

The Florida Department of Agriculture indicated that EPA should consider NLAA 

determinations for Bachman’s warbler for non-rice and rice uses of clomazone because this

species was “e

EFED response: According to the Fish and Wildlife Service’s profile for the Bachm

warbler, this species is “known or believed to occur” in Florida. Therefore, the effects 

determination for this species should remain LAA. 

The Florida Department of Agriculture indicated that EPA should consider NLAA 

determinations for the ivory-billed woodpecker for non-rice and rice uses of clomazone 

because this species was “Likely extirpated from Flo

“

EFED response: According to the Fish and Wildlife Service’s profile for the ivory-billed

woodpecker, this species is “known or believed to occur” in Arkansas and Louisiana. 

Therefore, for the states of FL and KY, the effects determination for this sp

m

The Florida Department of Agriculture indicated that EPA should consider NLAA 

determinations for Kirtland’s warbler for non-rice and rice uses of clomazone because this 

species is an “Infreq

F

15 http://ecos.fws.gov/docs/recovery_plan/070604_v4.pdf 

Page 28 of 35 
EFED response: According to the Fish and Wildlife Service’s multi-species recover

south Florida, the Kirtland’s warbler has been observed in several counties in Florida 

during migration periods. Therefore, the effects determination for this species should re

LAA. 

y plan for 

main 

28)

e 

t not likely impacted by drift from agriculture herbicides.” 

ct woody 

ine 

o the red-cockaded 

oodpecker. Any woody habitat used by the red-cockaded woodpecker that is 1-2 miles of 

29) ultural 

lm 

- Florida grasshopper sparrow 

s 

at 

ls 

ypericum 

w 

 

The Florida Department of Agriculture indicated that EPA should consider NLAA 

determinations for the Red-cockaded woodpecker for non-rice and rice uses of clomazon

because “Habitat (open, mature pine woodlands) not likely within 1,500 feet of fields. 

Habita

EFED response: Incident reports indicate that clomazone has the potential to impa

vegetation; therefore, woodland habitats may be impacted by clomazone exposure. This 

species relies upon large old pine trees to serve as cavity trees16; therefore impacts to p

trees due to clomazone could potentially result in indirect effects t

w

clomazone use (depending upon formulation) may potentially be affected by clomazone 

exposure. Therefore, the effects determination for this species should remain LAA. 

The Florida Department of Agriculture stated: “According to the 2007 Census of Agric

report, 11,376 acres of rice was grown in Florida and in only one county, Palm Beach 

County. Therefore, the endangered species assessment should only include listed species

found in Palm Beach County.” 

The Florida Department of Agriculture indicated that NLAA determinations should be 

considered for rice use on clomazone for the following species that are not found in Pa

Beach County: 

- Flatwoods salamander 

- Gulf sturgeon 

- Shortnose sturgeon 

- Britton’s beargras

- Scrub blazingstar 

- Florida bonamia 

- Scrub buckwhe

- American chafseed 

- Pygmy fringetree 

- Avon Park harebel

- Highlands scrub h

- Small milkpea 

- Garrett’s mint 

- Lakela’s mint 

- Scrub mint 

- Carter’s mustard 

- Beautiful pawpa

16 United States Fish and Wildlife Service. 2003. Recovery plan for the red-cockaded woodpecker (Picoides 

borealis): second revision. Available online at: http://ecos.fws.gov/docs/recovery_plan/030320_2.pdf. 

Page 29 of 35 
- Pigeon wings 

- Scrub plum 

- Lewton’s polygala 

ndron 

semary 

rt 

iphus 

 beach mouse 

ouse 

le skink 

se: According to USDA’s Census of Agriculture, in 2007 and 2002, rice was 

 A University of Florida Extension rice variety census 

 grown in Palm Beach and Hendry Counties and that in the 

rown in Glades County17. Therefore, in Florida, rice could 

potentially be grown in Palm Beach, Hendry and Glades Counties. Relevant listed species 

lm 

ies 

e, 

m use on rice) to these species and their habitats cannot be precluded. The 

ffects determinations for these species remain LAA. 

ach mouse 

ole skink 

 

- Chapman rhodode

- Etonia rosemary 

- Short-leaved ro

- Sandlace 

- Snakeroot 

- Deltoid spurge 

- Papery willow-wo

- Wireweed 

- Florida ziz

- Gray bat 

- Anastasia Island

- Southeastern beach m

- Bluetail mo

EFED respon

only grown in Palm Beach County.

indicated that in 2000, rice was

past, rice has also been g

that clomazone is likely to adversely affect include those that are known to occur within Pa

Beach, Hendry and Glades Counties. Since the action area for clomazone extends 2 miles

from the application site, relevant listed species that clomazone is likely to adversely affect 

(when considering use on rice) include those that are known to occur within the count

adjacent to Palm Beach, Hendry and Glades Counties, i.e., Broward, Collier, Lee, Charlott

Highlands, Okeechobee and Martin Counties, as well as any listed species inhabiting Lake 

Okeechobee. 

According to the US Fish and Wildlife Service or National Marine Fisheries Service, the 

following species are known to occur within Broward, Charlotte, Collier, Glades, Hendry, 

Highlands, Lee, Martin, Okeechobee or Palm Beach Counties. Therefore, clomazone 

exposures (fro

e

- Staghorn coral 

- Gray bat 

- Florida grasshopper sparrow 

- Gulf sturgeon 

- Shortnose sturgeon 

- Southeastern be

- Bluetail m

- Britton’s beargrass 

17 Schueneman, T. J. and C. W. Deren. 2000. Florida's 2000 Rice Variety Census. University of 

Florida IFAS Extension. Available online at: http://edis.ifas.ufl.edu/rh011. 

Page 30 of 35 
- Scrub blazingstar 

ls 

ypericum 

lygala 

ary 

w-wort 

e US Fish and Wildlife Service, the following species are NOT known to 

harlotte, Collier, Glades, Hendry, Highlands, Lee, Martin, 

 Palm Beach Counties. The effects determinations for these species will be 

 NLAA. 

Flatwoods salamander 

ent of Agriculture indicated that NLAA determinations should be 

 for rice use on clomazone, because rice grown in Palm Beach 

 from the coast.” These species include: 

- Staghorn coral 

t this time, EFED does not have sufficient sub-county level use data 

 refine the assessment beyond the NLCD data layer, which was used in the 

ated critical habitat for the elkhorn and staghorn corals occurs off the 

- Flroida bonamia 

- Scrub buckwheat 

- American chafseed 

- Pygmy fringetree 

- Avon Park harebel

- Highlands scrub h

- Garret’s mint 

- Lakela’s mint 

- Scrub mint 

- Carter’s mustard 

- Beautiful pawpaw 

- Pigeon wings 

- Scrub plum 

- Lewton’s po

- Short-leaved rosem

- Sandlace 

- Snakeroot 

- Papery willo

- Wireweed 

- Florida ziziphus 

According to th

occur within Broward, C

Okeechobee or

modified by EFED to

-

- Anastasia Island beach mouse 

- Small’s milkpea 

- Chapman rhododendron 

- Etonia rosemary 

- Deltoid spurge 

30) The Florida Departm

considered for several species

County is “well away

- Elkhorn coral 

- Piping plover 

- Smalltooth sawfish 

- Beach jacquemontia 

EFED response: A

specific to rice to

assessment. The design

Page 31 of 35 
coast of Palm Beach county18, potentially within the 1-2 mile distance from the edge of sites 

31)

[Everglades Agriculture Area].” 

ties. Therefore, clomazone exposures (from use on rice) to 

is species and its habitats cannot be precluded. The effects determination for this species 

32)

in 

unty in the EAA [Everglades Agriculture Area] (NASS 2007). This species is 

und on the Atlantic Coast Ridge.” 

. Therefore, clomazone exposures (from use on rice) to 

is species and its habitats cannot be precluded. The effects determination for this species 

33)

nge; limited habitat damage adjacent to fields not likely to pose a threat. 

etland exposure assessment greatly overestimates risk.” 

se 

i. 

34) he Florida Department of Agriculture indicated that EPA should consider a NLAA 

EFED response: In the ERA, EFED concluded that for clomazone use on rice, effects 

determinations for listed species of land-dwelling reptiles would be LAA for species with 

 

where rice may be grown. Piping plovers have been observed in Florida19. Juvenile 

smalltooth sawfish inhabit shallow costal waters20, which may be within 1-2 miles from 

clomazone use sites. The beach jacquemontia, which is a plant, is located in costal areas21. 

Based on this information, the effects determinations for these species will remain LAA. 

The Florida Department of Agriculture indicated that EPA should consider a NLAA 

determination for the Florida scrub jay for rice uses of clomazone because “habitat not likely

within 1,500 feet of rice fields. Rice is grown only in Palm Beach County in the EAA 

EFED response: According to the US Fish and Wildlife Service, this species is known to 

occur within Broward, Charlotte, Collier, Glades, Hendry, Highlands, Lee, Martin, 

Okeechobee or Palm Beach Coun

th

remains LAA. 

The Florida Department of Agriculture indicated that EPA should consider a NLAA 

determination for the tiny polygala for rice uses of clomazone because “Rice is grown only 

Palm Beach Co

fo

EFED response: According to the US Fish and Wildlife Service, this species is known to 

occur within Broward, Charlotte, Collier, Glades, Hendry, Highlands, Lee, Martin, 

Okeechobee or Palm Beach Counties

th

remains LAA. 

The Florida Department of Agriculture indicated that EPA should consider NLAA 

determinations for the Mississippi whooping crane for nonrice uses of clomazone due to 

“Large home ra

W

EFED response: The effects determination for this species in Florida should be NE becau

it is known to occur in Mississippi. In addition, its critical habitat is located in Mississipp

T

determination for the Eastern indigo snake for rice uses of clomazone because “limited 

impact to adjacent habitat not likely to impact species. Species has a large range.” 

18 http://www.gpo.gov/fdsys/pkg/FR-2008-11-26/pdf/E8-27748.pdf#page=1 19 http://ecos.fws.gov/docs/five_year_review/doc3009.pdf 

20 http://ecos.fws.gov/docs/recovery_plan/smalltoothsawfish.pdf 

21 http://ecos.fws.gov/docs/five_year_review/doc1054.pdf 

Page 32 of 35 
obligate relationships with plants, and NLAA for all other species. This species has a

range, uses a wide variety of habitats and is a carnivore22. Therefore, it does not appear

it has obligate relationships with specific plants. The effects determination for this 

 wide 

 that 

species 

should be revised to NLAA. 

35)

FED response: For non-rice uses of clomazone, the effects determination for small to large 

 a 

te 

glade snail kite has an obligate relationship with 

pple snails (Pomacea paludosa

The Florida Department of Agriculture indicated that EPA should consider a NLAA 

determination for the Everglade snail kite for nonrice uses of clomazone due to “Large home

range; limited damage to vegetation adjacent to fields not likely to impact apple snail 

populations or snail kite nesting sites.” 

E

carnivores is NLAA. LAA determinations are for birds that “are reliant or obligate on

limited number of plant species, a habitat that is dominated by a few species, have small 

localized populations, or are highly reliant on camouflage during late May through la

July.” Although it appears that the Ever

a ), this relationship is not expected to impact the kite because 

ons. 

36)

rge 

arnivores is NLAA. LAA determinations are for mammals that “are reliant or obligate on a 

all 

e 

a) . In addition, 

nce 1) “summer roosts are typically behind exfoliating bark of large, often dead, trees”25

to 

37)

 

clomazone is not expected to adversely affect aquatic invertebrates. Since birds are 

characterized as “nomadic,”23 it does not appear as if this species has localized populati

Therefore, EFED agrees that the effects determination for this species should be NLAA. 

The Florida Department of Agriculture indicated that EPA should consider a NLAA 

determination for the Indiana bat for non-rice uses of clomazone due to “Large range. 

Limited damage to vegetation adjacent to field unlikely to impact species.” 

EFED response: For non-rice uses of clomazone, the effects determination for small to la

c

limited number of plant species, a habitat that is dominated by a few species, have sm

localized populations, or are highly reliant on camouflage during late May through lat

July.”During the summer, Indiana bats have smaller home ranges (61-260 h 24

si

2) it is unlikely that there are a large number of tree species with these characteristics in a 

given area and 3) clomazone incident reports indicate that clomazone has the potential to 

impact woody vegetation, impacts of clomazone on the habitat of the Indiana bat is likely 

adversely affect this species. 

The Florida Department of Agriculture indicated that EPA should consider a NLAA 

determination for the gray bat for non-rice uses of clomazone due to “Large range. Limited 

damage to vegetation adjacent to field unlikely to impact species.” 

22 http://www.natureserve.org/explorer/servlet/NatureServe?searchName=Drymarchon+corais+couperi 23 http://www.natureserve.org/explorer/servlet/NatureServe?searchName=Rostrhamus+sociabilis+plumbeus 24 Menzel, J.M.; Ford, W.M.; Menzel, M.A.; Carter, T.C.; Gardner, J.E.; Garner, J.D. and J.E. Hofmann. 2005. 

Summer habitat use and home-range analysis of the endangered Indiana bat. Journal of Wildlife Management, 69 

(1): 430-436. 

25 http://ecos.fws.gov/docs/recovery_plan/070416.pdf 

Page 33 of 35 
EFED response: For non-rice uses of clomazone, the effects determination for small to large 

te on a 

te May through late 

uly.” EFED agrees that the gray bat has a large range . It does not appear as if this 

38)

es-specific comments that were provided. 

Cape Sable seaside sparrow – “This species and all available habitat currently found only 

)

27.” 

onal 

in 

(FNAI 2000).” 

ine rockland in Dade County.” 

00).” 

ary – “All known populations are on pine plantations and utility 

latwoods and adjacent wetlands mostly around 

ft 

 salt marsh vole – “Found in one marsh in Levy County (FNAI 2000).” 

omazone has the potential to be applied throughout the state of Florida, 

tate. In addition, 

 

carnivores is NLAA. LAA determinations are for mammals that “are reliant or obliga

limited number of plant species, a habitat that is dominated by a few species, have small 

localized populations, or are highly reliant on camouflage during la

26 J

species has obligate relationships with plant species. Therefore, the effects determination for 

this species will be modified to NLAA. 

The Florida Department of Agriculture indicated that EPA should consider NLAA 

determinations for several listed bird, mammal and plant species for non-rice uses of 

clomazone because their “habitat[s are] not likely within 1,500 ft of fields.” These species are 

listed below along with additional speci

-

in the Everglades National Park and Big Cypress National Preserve (FNAI 2000

- Florida grasshopper sparrow – “Clomazone drift not expected to significant damage 

(reduce food or cover) dry prairie habitat that requires frequent burning. All known 

populations occur on state and federal managed areas (FNAI 2000).” 

- Harper’s beauty –“Found only within bogs and moist roadside ditches in the 

Apalachicola National Forest (FNAI 2000).” 

- White birds-in-a-nest – “Found in grassy savannah and bogs in the Apalachicola Nati

Forest (FNAI 2000).” 

- Fringed campion – “Found in rich wooded ravines.” 

- Beach Jacquemontia – “Endemic to the SE coast of Florida. Most are located 

preserves.” 

- Cooley’s meadowrue – “Only one population found on a timber company land right-ofway in Walton County 

- Small’s milkpea – “All populations are on managed p

- Chapman rhododendron – “All populations are on private timber lands (FNAI 20

- Apalachicola rosem

rights-of-way (FNAI 2000).” 

- Florida skullcap – “Found in wet pine f

Apalachicola National Forest (FNAI 2000).” 

- Telephis spurge – “All plants are within four miles of the coast in the panhandle of 

Florida (FNAI 2000). Most occurrences are on private timberlands and utility rights-o

way.” 

- Anastasia Island beach mouse – “Most of Anastasia Island is in residential developmen

(FNAI 2000).” 

- Choctawatchee beach mouse - “Protected on state parks (FNAI 2000).” 

- Southeastern beach mouse – “Most are found on protected federal lands (FNAI 2000).” 

- Florida

EFED response: Cl

because non-rice crops for which it is registered are grown throughout the s

habitats that are located within 2 miles of the application site have the potential to be 

26 http://ecos.fws.gov/docs/recovery_plan/820701.pdf 

27 Florida Natural Areas Inventory (FNAI). Field Guide to the Rare Animals of Florida. 2001. www.fnai.org. 

Page 34 of 35 
Page 35 of 35 

e, 

clomazone may be deposited on areas inhabited by these listed species. The effects 

affected due to offsite transport of clomazone, primarily via volatilization. Therefor

determinations for these species should remain LAA.