# -

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 of EPA'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 of listed 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 10f35effective and efficient methods of identifying the unive rse of species that may be exposed and affected by the uses of these pesticides. Wh ile the fomesafen assessment used standard geographical tools refined with expanded biological characterist ics, the clomazone assessment used refined geographical proximity analyses in determining what species might and might not be exposed to the pesticide at levels of c oncern. Although the Agency explored new methods, both methods were considered to produce protect ive measures of potential risk. EPA’s risk assessments for clomazone and fomesafen are consis tent with scientific procedures outlined in the Agency’s Ecological Risk Assessment Process 1 , 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 ar e divided up by topic, including: clomazone use, characterizing exposure, character izing effects, risks, action area and listed species effects determinations.
ERB2 acknowledges the contributions of the fo llowing EFED scie ntists in completing this memo: Brian Kiernan, Faruque Khan, Anita Peas e, Melissa Panger, William Eckel, Melissa Grable and Ed Odenkirchen.

Clomazone Use: 1) NCC Comment: “In its estimation of the eff ect of clomazone on birds and mammals, the Agency used an application rate of 3 lb a.i./ acre for a banded applicati on. This rate is twice that of the label rate, the legal maximum that can be applied. When the co rrect rate is used in the model, clomazone poses a neglig ible 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. Enda ngered and Threatened Species Eff ects Determinations. United States Environmental Protection Agen cy, Office of Pesticide Programs. Available online at: http://www.epa.gov/espp/consulta tion/ecorisk-overview.pdf. Page 2 of 35Similarly, CLA also commented: “T-REX mo deling for direct exposure to birds and mammals utilized incorrect application rates th at overstated exposure, and thus risk, by a factor of two.”
EFED Response: According to th e Ecological Risk Assessment (ERA), the highest single application rate for clomazone is 1.5 lb a.i./A (for use on sweet pot ato). This rate was used to estimate exposures of non-target aquatic and terrestr ial organisms to clomazone (i.e., with PRZM/EXAMS, T-REX and TerrPlant).The assessmen t also considered exposures of terrestrial animals resulting fr om 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 th e band. This approach assumes that the concentration of clomazone is higher within the band, but the aver age application rate of clomaz one 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 nece ssary 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 rate s for clomazone were based on current formulated product labels.
3) t of Agriculture Commen t: “The authors state that the maximum us of clomazone on soybeans is 1.25 lb a.i./A, but the label of Commen ce EC herbicide from FMC corporation (EPA registra tion #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 pr oduction. 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 triflu ralin. 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 trif luralin. In terms of clomazone only, this rate applies to 0.69 lb a.i./A.

C

ma intain the water depth at four to five inches to promote maximum tillering while maintaining some weed control. The Cera no®5MEG label requires a mandatory, 14 water hold for maximum efficacy and allow degr adation of the product to an acceptable le before release.”

E 0.1 m, which is equivalent to 4 inches. This is consistent with the wate r 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 concentrati on of clomazone by accounti ng for degradation during that time.

C

Page 3 of 351) LA Comment: “Chronic risk assumptions ab out 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 cons ideration 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 exposur e estimates based on vapor-phase transport were based on provisional methods that were neither internally or externally peer reviewed.” C

no t refined as planned.”

E consuming grass, broadleaf plants and sma ll 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 e ffects of concern furt her evaluation o type and degree of expected effects indicate that reproductive effect s are not expected at these residue levels.” This c onsideration of the effects asso ciated with the NOAEC (NOAE of the 2-generation rat reproduc tion study constitutes a refinem ent, which resulted in a NLAA determination for direct effects to li sted mammals that consume grass, broadleaf plants and insects.

2 th e spreadsheet model ‘T-REX’ instead of us ing the ‘T-HERPS’ model, which was designed expressly for the estimation of ri sk to reptiles and amphibians.

E risks to terrestrial-phase amphi bians and reptiles. In this approach, dietary and dose-based exposures to birds are assumed to be conser vative 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 bi rds and terrestrial-phase amphibians and reptiles. If av ian RQs did exceed LOCs, T-HERPS may have been run to refine the estimates of clomazone exposure to terrestrial-phase amphibians and reptiles.

3 pr esent 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 pr edicted upper bound residue levels for these items. Clomazone can be applied as a soil tr eatment 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-fiel d.” Therefore, for clom azone use on cotton and soybeans, all dietary items considered using T-REX are relevant. RQs re presentative 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 ar ea. For banded applications to sweet potatoes, RQs for mammals consuming small insects excee d LOCs for acute and chronic exposures.

4

Page 4 of 35EF ED Response: As recommended by Scientif ic Advisory Panel (SAP) in December 2009

m eeting to address Field Volatilization of Conventional Pesticides, EFED will use the d ening

5) lomazone wa s greatly overstated based on an empirical odel that was not peer reviewed or validated for clomazone. Consequently, the predictions

ed that the vo latilization analysis ba sed on the work of (Yang and Holmen) will be withdrawn from the cl omazone 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 applicatio ns. Would it be more appropriate to use

to use model enerated drift fractions in the risk assessmen t and mitigation processes. One of the major label

8) ts, EPA conducted a Tier I assessment using TerrPlant, rather than conducti ng refined acute estimates. Since non-target Woodrow et al. (1977) correla tion approach to estimate a maximum 24-hour flux value an then could be used to calculate a maximum ai r concentration over 24- hours for the scre purpose.

CLA Comment: “Volatilization of c

m
ma de using those parameters are highly questionable. Registrant-submitted and published studies on clomazone demonstrate that EPA-OP P overstated the volatil ization of clomazone by at least an order of magnitude.”
EFED Response: EPA has determin
vetted by EFED technical teams (as stated in th e 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 volatiliza tion of clomazone. W
Ag ency show that the volat ilization of clomazone is si gnificantly less than 10%.”
EFED Response: As stated in #4, the Woodrow et al. (1977) correlation approach

u laboratory studies, they are curre ntly 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 th e laboratory due to di fferences in relative humidity, wind speed, temperature a nd spray formulation.
FL Department of Agriculture Comment: “Dri ft component sim gro Ag DRIFT modeling based on the dropl et requirements on the label?”
EFED Response: EFED concurs with the Flor ida Dept of Agriculture g obstacles for modeling was the lack of specific a pplication parameters in the product such as droplet size, release height and wind sp eed 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 par ameters in the product label. In addition, in absence of specific parameter related to appl ication, 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 35pl ants 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 la bel revisions and itigations ( i.e., buffers) for herbicides to protect lis ted 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 fr om 1 acre results in l0x the runoff into a

e: TerrPlant's 10 to 1 ratio of ta rget area to semi-aquat ic 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 estimate s, partly due to an over-reliance on modeling that is not scientifically defensible.” a evaluate potential exposures to te rrestrial 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 mile s 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 ap proach. Would it be more appropriate to us e PRZM modeling to determine the amount of loading into a surf ace 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 assessmen t. 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 Te rrPlant model. There is currently no vetted refinement for exposure to terrestrial plants fr om 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

wat erbody?”
EFED respons
a requirement of 2-acre drai nage areas per foot of dept h (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 purpos es and the expected depth of a semi-aqua

area.

CLA C

Page 6 of 35EFE D Response: The effects of buffer mitigation on sp ray 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 c an 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

C 50

re from registrant submissions and the scientific literature. EFED did not use th e 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 surr ogate species in a laboratory setting is not f those impacts on wild species that occur in fields, wetlands or

test effects on the endangered spec ies themselves. EFED agrees that mitigation measures should be as specific as possible. e current labels are in place to protect “To wns and subdivisions, Commercial Vegetable Production, Commercial Fruit Production, Commercial Nurseries, and Commercial Greenhouses”, and not wildlife habitat. Clomazon e labels do not include any buffers fo mitigation of runoff.
CRC Comment: “In California, the CRC has a thir ty-year history of managing water q programs relative to pesticide use. Collaborati on with the University researchers, State agencies, county agricu

m req uests that the registrants monitor pesticides in surface water the first year of registration. In addition, monitoring of agri cultural 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 toxi city in comparison to the lowest LC 50 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 dat a are available online 2 , 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 m easure should be triggered by dem impacts on particular species t a
an adequate measure o ri parian 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 se tting to assess potential impac ts 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 35CLA Comment: “Risk refinements for estuarin e and marine inverteb rates were based on inappropriate endpoints, such as using an Acut e 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 acut e and chronic toxicity data available for the EF ED Response: No chronic toxicity data were available for estuarine/marine invertebra exposed to clomazone. In order to estimat e a chronic endpoint fo r 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 ther e is a taxonomic effect on AC R and because the two ACRs within a factor of 10, it was a ssumed that there is no taxonomic effect on ACR. Therefore, th more conservative ACR was used. If valid chr onic 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 we re defi ata to

are
e

3)
cient in multiple ways (test species, ocumentation, nominal concentrations unc onfirmed by analysis, unclear units of

-

antos

assessm ent for clomazone. EFED will revise the ssessment using the 96-h LC 50 of 19 mg/L, which corresponds to exposures of rainbow trout

4) ffects

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

nificant damage to a high percentage of the plants in the community. Howe ver, no standard is

y. d

co ncentration, and many more flaws that w ould make this study ‘i nvalid’ under normal EPA OPP data evaluation procedures).”
EFED response: EFED has reviewed the publica tions indicated by CLA (i.e., dos S Miron et al. 2004 3 and 2005 4 ) 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 met hod for the determination of indirect e and impacts on designated critical habita t (under ESA) needs to be developed.

T he rbicides, are for effects on plant populati ons 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 real ity and it is not supported by data.

3 dos Santos Miron, D., Da Silva, L. V. F., Golombieski, J. I., De Olivei ra Machado, S. L. , Marchezan, E., and Baldisserotto, B. (2004). Lethal Concentration of Clomaz one, 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, Quinclor ac, and Metsulfuron Methyl on Acetylcholinesterase Activity in the Silver Catfish ( Rhamdia quelen ) (Heptapteridae). Ecotoxicol.Environ.Saf. 61: 398-403 Page 8 of 35With respect to critical habitat, the clomazone assessment attempte d 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’ ob ligation of evaluating actions

e

rcumstances that contribute to species’ protection or lack of exposure.

es that will vary seasonally as to plan t height and biomass. They will vary yearly due to normal variations in temperature a nd 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 po tential effects on desi gnated critical habitat

population) values from both seedling emerge nce 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 utiliz e those as screening crite ria for whether or not designated critical habitat might be affected. If these elements are not in the vicinity of an application, even if the a pplication is within or near designated critical habitat, there may b no need for further assessment.

Of even more concern are the tw o drastically different approach es 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 variab ility in vegetation that non-t arget species are likely to encounter in the wild should be considered. Fo r 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. Applic ation practices studies, observations from fiel d trials, and many other factors are considered in establishin use parameters that mitigate risk, and these fact ors are extremely important to consider in the risk assessment, particularly when multiple underlying assumptions grossly exaggerate th presumed indirect effects and impact on desi gnated critical habitat. Furthermore, in extrapolating risk from non-targ et plant testing, (1) the tes ting 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) m easured endpoints are not readily translated to effects on populations and communities in the fi eld. As a consequence, herbicide specific characteristics such as mode and mechanism of action, application methods and time, spectrum of activity and selectivity and the natu re or severity of ef fects are critically important to the interpretation of impact, but the evaluation of th ese factors is lacking in bot the clomazone and fomesafen assessments.”
EFED Response: The Agency acknowledges the un certainties associated with the app used to evaluate indirect effects and impacts on designated critical habi tat for national-level endangered species risk assessments. Curren
and follows EFED’s current practice id entified in US EPA (2004).
With respect to terrestrial plants, the EC 25 (effect concentration to 25% of the test

Page 9 of 35both Monocotyledones (monocots) and Dicotyledones (dicots) ar e used as the measurement endpoints to determine the poten tial for ecologically significant direc t 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 requireme nts; cover or shelter; sites for breeding,
s of

the d

eight5) icity or

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

a od complete their life cycle. The NOAEC (no obs erved adverse effect concentration) v used as the measurement endpoint for direct effe cts to listed plant spec ies and indirect effects to listed species that rely on a specific plant species in their li fe cycle (termed plant species obligates). Guideline studies generally evaluate toxicity to ten crop species. A drawback to these tests is that th ey are conducted on herbaceous crop sp ecies only, and extrapolatio effects to other species, such as woody sh rubs and trees and wild herbaceous species, contributes uncertainty to risk c onclusions. While it is recogniz ed that the current battery of required guideline terrestrial plant toxicity tests for pesticides is limited in characterizing th sensitivity of all types of veget ation that non-target sp ecies are likely to en counter in the wild, the Agency attempts to make use of the best av ailable information by considering relevant data from the open literature as well as any registrant-submitted studies that provide additional information on the variab le sensitivity of plants.
Given the large number of listed species for whic h critical habitat exist s, a specific analysis of each primary constituent element (PCE) fo r each designated critic al 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 be havior; fo
reproduction, rearing (or development) of offs pring; and habitats that are protected from disturbance or are representative of the histor ic geographical and ecologi cal distribution a species. Given that terrestrial plants serv e as habitat, shelter, food, and/or cover for a variety of invertebrate and vertebrate listed speci es, 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 antic ipates 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 d evelopment of methodologies to characterize potential modification of PCEs and associated designated critica l habitat as well as indirect effects analysis to listed species is needed. If available, these new methodologies will be incorporated into the revised clomazone regi stration review risk assessment. If new methodologies to evaluate indirect effects are not available at the time of the revised assessment, the Agency will attemp t to refine the indirect effe cts analysis based on a w of-evidence approach using the best availa ble information, and thereafter based on consultation with the Services.

CLA Comment: “EPA estimated LD 50 or LC 50 values from studies that showed no tox lethality at limit doses (single dose limit st udies), using a non-peer reviewed, unvalidated procedure to extrapolate from the tested limit concentration to an LD 50 or LC 50 value

th e highest treatment levels in acute and s ub-acute studies conducted with bobwhite quail and mallard duck. In order to estimate the LD 50 and LC 50 values for birds, EFED applied provisional method based on the dose-respons e curve and slopes ranging 2-9. This meth

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

6) f

damage because individual plants typically outgrow the damage.”

s

cal needs of individual listed species ar e 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 obser ver, including bleaching. NOAEC va lues for phytotoxicity, dry acute exposures do not pose risks to birds and te rrestrial-phase amphibians and reptiles.

NCC Comment: “EPA states that the establishmen t 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.”

Si milarly, CLA commented: “Plant recovery, an important area of refinement for clomazone, was not considered in refining th e risk equation for plants and i ndirect effects in general. The bleaching effect of clomazone is obvious as a diagnostic tool, but as a symptom does not necessarily indicate ecol ogically significant

EFED Response: The action area is defined as the area where eff ects may reasonably be expected to occur. Data allowing EPA to evalu ate 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 incide nt reports of clomazone effect s on plants. This information indicated that exposure to clom azone can affect plants for mont hs 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.” Phytotoxic ity is a subjective measur e o th weight and height from a seedli ng emergence study with clomazone are provided in the table below (from Appendix B). In most cases, the NO AEC 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 dr y 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 Soybe an >1.5 ≥ 1.5 0.5 Carrot 0.0185 0.167 0.0556 Cabbage 0.0556 0.167 0.167 Tom ato 0.0185 0.0029 0.0185 Lettuce <0.0 062 0.0019 0.0009

Page 11 of 357) 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 (EC 25 s and NOECs) adequately represents federally listed

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

fects to liste d species as the tested species represent a taxonomic range of plants which also ar e commonly found growing wild e.g., legumes,

ess the

l

8)

ew on assumptions, and the relevance of the observation to actual clomazone use coul d not be established. EPA-OPP neglected to nges in

bed
umbers of incidents to changes in use of the esticide since reporting requirements ha ve 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 a ssessment, and valid data available to the e applie d inconsistently.” gricultur terrest tests wer

nfid ent t ies (crop plants) used ent endpo p
ve getative vigor studies adequate for determ ining impacts (survival, reproduction and growth) on listed plant species?
EFED response: The Agency recognizes that terr estrial plant species se lected for testing are typically annual crop species. While there ma y be differences in response between crop species and native vegetation, these data repres ent 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 st udies 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, add itional data may be required.
CLA Comment: “Incident reports were accepte d as indicative of ecosystem injury at locations far removed from or doubtfully attr ibuted to clomazone application. Very f incident reports were judged to be definite ly associated with clomazone use because documentation was incomplete, conclusions were based

re late the declining num ber of incidents to reduced clomazone exposure based on cha formulation, labeling an d application methods.”
EFED Response: On p. 64-68 of the ERA, EFED summarized the reported ecological incidents for non-target plants th at were associated with clom azone. This summary descri the occurrence of these incident s by formulation, over time and distance from the edge of the treated field. It is difficult to attribute dec lining n p reporting requirements for incide nts in 1998 likely partia lly account for a reduced num reported incidents. Registrant s 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 generall y 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 th e conclusions reached in EPA-OPP’s risk assessment do not rectify conflicting informa tion when interpreting the risk assessment outcomes fo

a assessment wer

Page 12 of 35EF ED 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 effe cts 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 prac tice. 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 redu ces the possibility of on-target impacts. Any potential impacts from off target applic ations should be evaluated

ls

d in number of spec ies. The agency would welcome any additional plant toxicity da ta 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, ‘Operation ally 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 assumpti on of 100% crop treated. Yet, clomazone use is cotton is estimated to be less than one percent of the cotton

EF ED 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 poten tial 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 th e 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 availa ble spray equipment coupled with grower’s vigilance in watching

n fo r 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 co ncern to listed plant species and non-listed species as a general resource have already b een reviewed by the Federal Insecticide Fungicide Rodenticide (FIFRA) Science Adviso ry Panel (SAP). The data set for clomazone, regarding indirect plant effects, is limite
species on which listed species depend. Additiona lly, the intent of the EPA’s risk assessment process for pesticides is proac tive and is intended to avoid im pacts on non-target spec the first place. Given the large and thriving agr icultural industry in the United States of which agricultural pesticide usage is an integr al part for most crops, evidence suggests that mitigation measures are not ma king 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 35assumptions concerning the likelihood of expos ure and magnitude of effects from direct exposure.”

ction area: 1)

or are expected to be infrequent as i ndicated by the incident information.’ It is difficult to understand w hy 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) consiste ntly applied for registration revi ew and 2) is consistent with

3)

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

will d vertebra te species. This is base d 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 ro ws, roadways, and residential properties. These

rudent
) in EF ED Response: The Agency will consider the more specific comments provided by the FL Dept of Ag in its letter to the Agency (D ated 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 do cument states, ‘Events outside 1,500 feet f the EC, WP and ME formulations

events whi

re sidential 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 me thod for determining and describing “actio area” needs to be guided by a clear Standard Operating Procedure”
EFED Response: EPA i p th e Services regulations. The Agency is also br inging 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 fr om treated fields and consist of off-field b

ar eas are typically considered to be open or semi-open canopy environments that do not represent many native plant comm unities. 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 bot h 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 (kil ling of vegetation these habitat zones it is not appropriate to a ssume that these areas [those within 300 ft of

Page 14 of 35EOF] would be utilized by liste d 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 hi ghly 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 invol ves consideration of each species’ habitat requirements and the availability of those requ irements within predic ted impact areas. EFE will consider the Florida Department er of
July.’

ed

ted

D of Agricu lture’s species specific comments that were provided in the August 19, 2009 letter submitted to the Agency.

Lis 1)

s where sp atial 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 (E Os) were within the “effect area” of 1 or 2

2) s: “In

, y d and affected by the uses of thes e pesticides. While the fomesafen assessment sed standard geographical tools refined w ith expanded biological characteristics, the ted Species Effects Determinations: CLA Comment: “Species have b een assigned ‘may affect’ dete rminations in many instances where there is no geographic proximity, or wher e other clear and signifi cant factors exclude being of concern.”

FESTF Comment: “In several instance

on ly outside of the action area, EFED incorrectly concluded a ‘may affect’ determination despite spatial relationships i ndicated 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 us e area. Potential “

w miles from the edge of cropped land. This assess ment did consider sign ificant factors related to types of listed species that would lead to Not Likely to Adversely Affect (NLAA) determinations. For example, in cases where cl omazone may affect some listed species based on spatial overlap of use areas (and th e 1-2 mile buffer) and species EO, NLAA determinations were made fo r 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 assessment 5 , EPA note conducting these first two national listed specie s assessments and effects determinations EPA explored effective and effi cient methods of identifying th e 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 Br yan Arroyo, Assistant Direct or for Endangered Species (USFWS) and James Lecky, Director (NMFS). April 22, 2009 and EPA-OPP Fact Sheet at http://www.epa.gov/oppsrrd1/REDs/factsh eets/clomazone-fomesafen-fs.html. Page 15 of 35clomazone assessment used refined geographica l proximity analyses in determining what species might and might not be exposed to th e 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 expa nded biological charac teristics” nor should the clomazone assessment have ended with “geo graphical proximity analyses” that add only a fraction of the data availa ble 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 c ontinue to explore other methods as well as

4) e, communi cation late in the pr ocess of Registration Review resulted in EPA-OPP allowing insuffi cient time to assimila te and understand the “proximity analysis,” that re lied upon EO data from NatureServe and maps of cropped land from the NLCD to determine the distance betw een 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 fine r resolution of “May Affect ” calls than the county-level LOCATES database would support. It is EPA’s in tent to use biological information to re effect determinations routinely in the futu re, however at the time of the assessment, a comprehensive database of relevant biological factors was not ava ilable from the Se

CLA Comment: “The stated basis of the effect s determination for clomazone and fom were admitted by EPA-OPP to be different, intended as a way to explore and define

as sessment 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 curre nt cases, EPA-OPP did not fully utilize the data available to it. For clomazon

ex tremely useful yet logistically overwhelm ing data presented to the Agency by the registrant’s data submission using FESTF data 6 . Reliance on such data in the case of clomazone would have provided:
a) A current and comprehensive, robustly doc umented and quality tested, tabulation of listed species and critical habita t. 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 li sting status or specifics have changed. Inclusion of certain species in the EPA-OPP assessment did not follow the procedur al guidance of the

6 Frank AR. 2009. Clomazone: analysis of potential direct an d indirect effects on threat ened and endangered species. January 13, 2009. FIFRA Endangered Species Task Force (FESTF), Washington, DC and FMC Corporation, Princeton, NJ. MRID 4764701. Page 16 of 35Se rvices 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 cu rrent, comprehensive species listing and critical habitat information in effects determina tions, 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 availa ble information on species locations, proximity to crops of intere st, 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 assessm ent itself. By using FESTF and registran tsubmitted 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 de velop a database of relev ant biological factors

c) le aving only a small fraction of obscure or little understood species for consultatio more intensive analysis.”
EFED response: EPA recognizes the value of cu rrent, comprehensive data on biologica parameters useful in effect determinations (juvenile and adult body weights, diet, metabolic rates, ecological data such as ob ligate relationships between species, and an others deemed necessary b
that is acceptable for use in effect determi nations. Again, presentation of data in GIS format, wherever possible, would be most useful.
A reduced subset of species requiring co mprehensive analysis based on a current portrayal of co-occurrence between species lo cations 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 seed ed ri ce, while with the benefit of more current and comprehensive data, the FESTF/ FMC assessment demonstrated that it was strated

ot

n

) ne cessary 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 seed ed and dry seeded). This species was n assessed in the FESTF/FMC assessment b ecause it only occurs in San Bernardino County, California which is not a reported ri ce growing county or adjacent to any rick growing counties.”
EFED Response: For determining co-occurren ce 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 asse ssment 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 referen ce to use of data presen ted in the FESTF IMS,

Page 17 of 35EP A 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 (s patial and biological) available in the FESTF IMS and FMC species assessment th at could be used to support effects determinations resulted in erroneous conc lusions about species exposure and greatly expanded the consultation request. For exampl e, the comment to the docket provided b North Dakota, when compared to the c onclusions reache y d by FESTF/FMC and those reached by EPA-OPP, further supports the fi ndings of the FESTF/FMC assessment rather

rmat and th an those of EPA-OPP.”
EFED response: Data from field offices and st ates 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 scien tific approach, allowing for EPA-OPP’s assessments to be refined and to focus in on the species with gr eater potential for expos ure, and thus also focusing the scope of and efficien cy of consultation, if required. The IMS assessment provided EPA with information on species habi tat, diet, proximity to potential clomazone use sites, locations of reported use sites, st atements from species experts, and many other types of information that are extremely impor tant t o 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 EF ED response: EPA appreciates CropLife Americ a’s efforts to provide relevant data for species effect determinations. As stat ed 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 s ources is of cou indispensible. To that end, the separation of objective information (e.g., Services’ o
poorly documented information (e.g., informatio n taken from reports in draft form) in FESTF submissions would be very helpful.
Department of Agriculture Comment: “E ndangered species loca tions 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 lo cations 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 frin ged orchid section.”

EF ED Response: The U.S. Fish and Wildlife Service (USFWS) provides species locat information at the county-l evel on their endange red species website. Furthermore, EPA/OPP’s Endangered Species Protection Prog ram (ESPP) generates bulletins with enforceable pesticide use limitations on a count y-level basis. That said, if species location

Page 18 of 35data provided by North Dakota’s Department of Agriculture or ot her agencies meet EPA’s standards, these data will be incorporated in to the risk as sessment process.
6) e the data

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

ot

and

ad two robust data sources to build th e 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 re gistration 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 Agricultu re Statistics Service (NASS) Cropland layer issued in March of 2009 fo r most states. The data is from remote sensing based cropland acreage indications and veri fied with on the ground surveys.

th e Indian Government. The sa tellite’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 MODI S. 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 ove r the non-agriculture domain. NASS uses a software combinati on of ArcGIS for ground truth editing, ERDAS Imagine and See5 for image processi ng, 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 Agricultur e Survey data is used for building regression models and estimating acreage. During th e survey 41,000 farms are contacted and 11,000 one square mile sample area segments are vi sited. The information provided by NASS is county and state level “major crops”.

M http://www.nass.usda.gov/resear ch/Cropland/metadata/meta.ht ”
EFED Response: The proximity analysis from FESTF used NASS data. The Agency is exploring the utility of CDL fo r use in proximity analyses.

N species and areas in which clomazone is labele data is the best available information for e ndangered species in N b county-wide level. We realize that before this data can be used by the EPA the quality

Page 19 of 35c ontrol 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 re view to impose clomazone restrictions in North

ate
or example, in Richland County of North Dakota, western pr airie fringed orchids re found in the eastern one-fourth of the c ounty. Most areas of th e county are not found

other

10) location data for endangered species before se tting any use restrictions or mitigation for fo r 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 endangere d species and areas in which clomazone is labeled f use in North Dakota. If species location dat a 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 st ate 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 reque st, including state cr opping data, soil maps, pesticide use and environmental monitoring data.”

pr ovide data for EPA’s consideration. EFED recommends that PRD request that the ND Department of Agriculture provid e the data discussed in their co mment. If the data provided by North Dakota’s Department of Agricultur e 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 fringe d 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 undi sturbed areas in parts of Rans om and Richland Counties in the southeast part of the state. For this reason, we feel strongl y d Da kota.”
The data used in the registrati on 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 th ese areas while still protecting endangered species. F

a within two miles of western prai rie 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: “Mos t importantly, EPA should use more refined
listed species.”

Page 20 of 35EFED 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 sm all portion of that da ta as was done in its ndangered species effects determination on cl omazone. 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 EP A-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 unders tands the challenges EPA-OPP faced in e for a to spe cies 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 fi nd utility and efficiency by using all of t species data provided to it through any assessment utiliz ing the FESTF’s Information Management System, rath

e
ass essments 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 EP A both during the Registration Review process and in the ESA c onsultation 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 inte rest 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 pe riod of time available to it fo r a national-level endangered species assessment, and seeks to continue to work with EPA to s upport their use of access to the best available data as provided th rough 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 a ccess to a similarly robust species data compilation. For specific details to enhan ce the EPA-OPP assessments on clomazone an fomesafen, please see the detaile d information about species da ta as reviewed in their individual responses to the case dockets. 7

CLA Comment: “For both the clomazone a nd fomesafen assessments, EPA-OPP h available FESTF-submitted data on species locations, species biol ogy, 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 da ta over the short period of time availabl national-level endangered species assessment. CL A seeks to continue to work with EPA

7 Responsive comments to clomazone, by FMC, and fomesa fen, by Syngenta, to the respective case dockets EPAHQ-OPP-2006-0113 and EPA-HQ-OPP-2006-0239, August 2009. Page 21 of 35support its access to and use of th e best available data in its assessment of endanger effects.”
EFED Response: EPA appreciates FESTF’s effo rts to provide data on species locations, proximity to cropped land, and species biolog y in support of list ed species effect determina ed species

tions. EFED did not use these data because of c oncerns 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 holis tic 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, allo wing the EPA scientist to comprehend the relationship of species range (inc luding critical habitat) to rele vant land cover classe case of clomazone, cultivated land), and to ge ographic 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 (f omesafen) and spati (clomazone) approaches, EPA is addressing through the now-emerging process ques

EPA -OPP on endangered species to addre ss the requirements of PR Notice 2000-2, EPAOPP strongly advised that getti ng species not likely to be ex posed to a given use “off the table” was an important predecessor to more time consuming refined risk assessment. In fact, in an early feasibilit y study on the use of spatial data for species assessment, 8 FESTF learned (and EPA later concurred 9 ) that spatial data alone was not a satisfactory solution t species evaluation. One objective in species a ssessment 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 base d and free of multiple assumptions about exposure and risk. However, lack of process is inhibiting c onsensus: clear guidance on data sources and approaches needs to be developed because inevit ably there will be differences in scientific opinion that are only compounde d when the underlying struct ure is unclear. Those differences are much harder to assess and re solve if methodology is inconsistent and not driven by transparent pro cesses and clear policy.”

8 A proposal to satisfy EPA requirements fo r 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 Descri ption 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 Te chnical Administrative Chairs to Arthur-Jean Williams, Branch Chief, EFB. July 1, 1997.

Page 22 of 35EFED 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 identi fied 296 species. EPA’s greater number of species was ag ain 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 fr om 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 cons istent with scientific proced ures outlined in the Agency’s Ecological Risk Assessment Process 10 , 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 sp ecies locations and potential clomazone use sites. Moreover, much of the information (s patial and biological) available in the FESTF IMS that could be used to support effects dete rminations was not utilized by EFED, largely due to resource limitations and lack of familia rity with the tools... FESTF is willing... to assist EPA in understanding and utilizing these tools...”
FESTF Comment: “In initially setting up the FE STF/FMC assessment, a more precise list of species was generated using th e 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 th e crop under evaluation.”
FESTF Comment: “Reliance on spatial data and on ly cursory attention to species attributes (habitat, diet and other biological factors) re sulted 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 th at 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 ot her habitat characteristics and us e 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. Enda ngered and Threatened Species Eff ects Determinations. United States Environmental Protection Agen cy, Office of Pesticide Programs. Available online at: http://www.epa.gov/espp/consulta tion/ecorisk-overview.pdf. Page 23 of 35assessment “... due to resource limitations and la ck of familiarity with the tools.” EPA previously commented on FESTF IMS (Inf ormation 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, incorporat e IMS data into the revised assessment for clomazone.

FESTF comment: “The additional data that wa s 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. eff ects” or “not likely to a dversely 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. EP A will, to the extent practical, incorporate IMS data into the revised assessment for clom azone. 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 b ehavioral exposure to clomazone use. For example, many of the Fl orida 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 in formation that would likely have changed many of EPA’s ‘may affect’ determinations to lesser affect status, t hus 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 ex ample, species elevation and information regarding mountain ranges between potential clomazone use site s 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 eff ect determinations because the “effect area” around pesticide use sites is based on the distanc e from
spray drift, downstream dilution, and in the case of clomazone, volatilization and redeposition to terrestrial ecosystems. Base d 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 th e effect area. as mentioned before, the manner of presentati on of IMS data makes it impractical in many cases to use it in a holis tic manner in effect determinations in a nationally consistent ma

Page 24 of 3516)
through the IMS, to non-rice crops on the label.”

idered.
17) ent due to the data management aspects available to the IMS user.”

l tiple listings for the same species.
18) pecies are ocumented as no longer found in given areas an d thus not subject to clomazone exposure.

U.S.

nger listed and add any spec ies that have been listed since the ERA was completed. In terms of species with modifie d 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 sp ecies 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 assessmen ts for non-rice uses, EPA failed to include two species that should have been evaluated based on their potential adjacency, as identified

EFE D response: EFED would like to request clar ification 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

EFE D 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 longe r necessary. Similarly, some s d EPA -OPP did not access such information for thei r assessment. References are available in the FESTF IMS to support this information and are consistent with da ta found in the Fish and Wildlife’s Species Profiles, and full references are provide d and uploaded to the IMS so that such information ca n be verified by EPA or the Serv ices 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 gene rated 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 lo cation 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 overla pping 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 wh ich 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 35EFED Response: As indicated above, the clomazone assessment used EO data from NatureServe and maps of cropped land from th e 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 cul tivated cropland) of pesticides used in

s

21) gnated area (including future use sites). Potential “M ay Affect” situations were thus limited species whose locations (EOs) were within the “e ffect area” of 1 or 2 miles from the edge of cropped land.

FESTF Comment: “There is no dis tinction between proximity of species locations to various non-rice uses. T

spe cies locations being found to be in proxim ity to NLCD class 82 (agricultural lands).”
EFED Response: The NLCD data are currently th e 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. O PP is, however, exploring additional data resources that may allow for the refinement of potential use sites. For example, the United State Department of Agriculture (USD A) National Agricultural Sta tistics Service (NASS) is developing cropland data layers that represent in dividual crops. These data are currently only available for selected states. When these become available nationally, OPP will consider how they may be used in pl ace of the generaliz ed NLCD data.
FESTF Comment: “EFED erroneously reported that87 listed species di d not have desi critical habitat when in fact they do.”

EFE D response: EFED agrees that it erroneously reported that several listed species did not have designated critical habitat wh en this is not the case. For example, EFED reported that th e 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 critic al habitats and correct any errors in cases when final desig nated critical habitats are established.
The North Dakota Department of Agriculture indi cated that “There are seven threatened or endangered species in North Dakot a, 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 a nd that indirect effects to sma ll and to large carnivores would ( Mu stela 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 35not 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 la st black footed ferret sighti ng in North Dakota was in 1970.”
EFED response: In the ERA, the effects determina tion for small to large carnivores is N rice uses of clomazone. For non- rice uses of clomazone, the e ffects determination for small E for
to large carnivores is NLAA; however, for specie s 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 dur ing each migration, so if a location has a

x by a few species (e.g., prairie grassland), ha ve 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 eff ects determination is L AA (Table 47 of ERA). Since black-footed ferret pr imarily consumes prairie dogs 11 , EFED agrees that the blackfooted ferret is a carnivore. According to the US Fish and Wildlife Se rvice's profile for black-footed ferret 12 , this species is "well adapted to its prairie environment. Its color and markings blend so well with grassland soils and plants, that it is har d 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 cran es do not rely on obligate to a limited number of plant W subpar habitat, the whooping cran es could easily fly to a better foraging or roosting area. For this reason we believe indirect effects to whooping cranes in Nort h Dakota should be not likely to adversely affect, instead of the likely to adversely affect that is listed in Appendi I.”

EFE e D response: Originally, an L AA effects determination was m ade for the whooping crane du to potential indirect effects of clomazone through effects to vegetation be cause this species has

“ small localized populations.” According to the US Fish and Wildlife Service 14 :

- 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 w inters in

c oastal marshes in Texas at Aransas. In addi tion, there is a small captive-raised, nonmigratory population in centr al Florida, and a small migrat ory population of individuals introduced beginning in 2001 that migrate be tween Wisconsin and Florida in an eas tern migratory population.”

- “During migration, whooping cranes use a va riety of habitats; however wetland mosaics appear to be the most suitable. For feed ing, whooping cranes primarily use shallow, seasonally and semi perm anently flooded palustrine wetlands for roosting, and various cropland and emergent wetlands.”

11 Hillman, C.N. and T.W. Clark. 1980. Mustela nigripes. Mammalian Species (Publicatio n of the American Society of Mammalogists), No. 126, p. 1-3. 12 http://ecos.fws.gov/speciesProfile/prof ile/speciesProfile. action?spcode=A004 13 http://www.fws.gov/mountain-prairie/s pecies/mammals/blackfootedferret/ 14 http://ecos.fws.gov/speciesProfile/prof ile/speciesProfile.action?spcode=B003 Page 27 of 35- Groups of whooping cranes may have traditional stopover sites during migration 15

. Based on this information, impacts to the habitat of this species, in particular in tradition stopover sites, are considered Likely to Ad versely Affect the speci es during migration. al

t

use and preferably, if available, s ub-county spatial data for both land use or speci es 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) no t likely within 1,500 feet of fields.”

ecies should be odified to NLAA.
27)

uent vis itor to South Florida. They ar e not dependent on habitat in lorida.” 2 3) Florida Department of Agriculture Comment:“La stly, we feel that th e Agency has not ye refined the endangered species assessment ad equately using, at a minimum, descriptive characterization of the species locations or habitat requirement s in relation to crop/land

EFE D 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 availa ble and meet EPA’s standards.
The Florida Department of Agriculture in dicated 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 adj acent to fields not likely

a

EFE D response: As indicated above, for loca tions 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-ri ce and rice uses of clomazone because this species was “e

EFE D response: According to the Fish and Wild life Service’s profil e 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 woodpeck er for non-rice and rice uses of clomazone because this species was “Likely extirpated fr om Flo

“

EFE D response: According to the Fish and Wild life Service’s profil e for the ivory-billed woodpecker, this species is “known or beli eved to occur” in Arkansas and Louisiana. Therefore, for the states of FL and KY, the eff ects determination for this sp

m The Florida Department of Agriculture indicated that EPA should consider NLAA determinations for Kirtland’s warbler for non-ri ce 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 35EFE D response: According to the Fish and Wild life Service’s multi-sp ecies recover south Florida, the Kirtland’s wa rbler 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-co ckaded woodpecker for non-rice and rice uses of clomazon because “Habitat (open, mature pine woodla nds) not likely within 1,500 feet of fields. Habita

EFE D 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 trees 16 ; therefore impacts to p trees due to clomazone could pot entially result in indirect effects t

w clomazone use (depending upon formulation) ma y potentially be affected by clomazone exposure. Therefore, the effects determina tion 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 Fl orida and in only one county, Palm Beach County. Therefore, the endangered species a ssessment should only include listed species found in Palm Beach County.”

The Florida Department of Agriculture indi cated that NLAA determinations should be considered for rice use on clomazone for th e 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 fo r 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 po lygala ndron

semary

rt
iphus

beach mouse

ouse le skink
se: According to USDA’s Cens us of Agriculture, in 2007 and 2002, rice was A University of Florida Extensi on rice variety census grown in Pa lm Beach and Hendry Counties and that in the rown in Glades County 17 . Therefore, in Florida, rice could potentially be grown in Palm Beach, Hendry and Glades Counties. Rele vant listed species lm

ies
e,

m use on rice) to these speci es 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

E

FED respon

o nly grown in Palm Beach County. i ndicated that in 2000, rice was p ast, rice has also been g
that clomazone is likely to adve rsely 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 t hat are known to occur within the count adjacent to Palm Beach, Hendry and Glades Countie s, 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 Servi ce or National Marine Fi sheries Service, the following species are kn own to occur within Broward, Char lotte, 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. Flor ida's 2000 Rice Variety Census. University of Florida IFAS Extension. Available on line at: http://edis.i fas.ufl.edu/rh011. Page 30 of 35- Scrub blazingst ar

ls ypericum

lygala ary

w-wort

e US Fish and Wildlife Servi ce, the following species are NOT known to harlo tte, Collier, Glades, Hendry, Highlands, Lee, Martin, Palm Beach Counties. The effects determinations for these species will be NLAA. Flatwoods salamander

ent of Agriculture indi cated 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 criti cal habitat for the elkhorn an d 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

A ccording to th

o ccur within Broward, C O keechobee or

m odified by EFED to

-

- Anastasia Island beach mouse

- Small’s milkpea

- Chapman rhododendron

- Etonia rosemary

- Deltoid spurge

3 0) The Florida Departm

c onsidered for several species C ounty is “well away

- Elkhorn coral

- Pi ping plover

- Smalltooth sawfish

- Beach jacquemontia

E

FED response: A

s pecific to rice to

a ssessment. The design

Page 31 of 35c oast of Palm Beach county 18 , 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 de termination for this species

32) in unty in the EAA [Everglades Ag riculture 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 de termination for this species

33)
nge; limited habitat damage adj acent to fields not likely to pose a threat. etland exposure assessment greatly overestimates risk.”

se i.
34) he Florida Department of Agriculture in dicated that EPA should consider a NLAA

EFED response: In the ERA, EFED concluded that for clomazone use on rice, effects determinations for listed speci es of land-dwelling reptiles wo uld be LAA for species with where rice may be grown. Piping plo vers have been observed in Florida 19 . Juvenile smalltooth sawfish inhabit shallow costal waters 20 , which may be within 1-2 miles from clomazone use sites. The beach jacquemontia, wh ich is a plant, is located in costal areas 21

. Based on this information, the effects determin ations for these species will remain LAA.
The Florida Department of Agriculture in dicated 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 gr own only in Palm Beach County in the EAA

EFE D response: According to the US Fish and W ildlife Service, this species is known to occur within Broward, Charlo tte, Collier, Glades, Hendry, Highlands, Lee, Martin, Okeechobee or Palm Beach Coun th remains LAA.
The Florida Department of Agriculture in dicated 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

EFE D response: According to the US Fish and W ildlife Service, this species is known to occur within Broward, Charlo tte, 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 Missi ssippi whooping crane for nonrice uses of clomazone due to “Large home ra W

EFE D response: The effects determ ination for this species in Fl orida should be NE becau it is known to occur in Mississi ppi. In addition, its crit ical habitat is loca ted 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 35obl igate relationships with plants, and NLAA for all other species. This species has a range, uses a wide variety of habitats and is a carnivore 22 . Therefore, it does not appear it has obligate relationships with specific plan ts. The effects determination for this wide that species should be revised to NLAA.
35)

FED response: For non-rice uses of clomazone, the effects determinatio n for small to large

a

te glade snail kite has an obli gate relationship with pple snails ( Pomacea paludosa The Florida Department of Agriculture in dicated 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 ki te nesting sites.”

E

car nivores is NLAA. LAA determinations are fo r 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 expe cted to impact the kite because

ons.

36)

rge arnivores is NLAA. LAA determinations are fo r mammals that “are reliant or obligate on a all

e a) . In addition, nce 1) “summer roosts are typically behi nd exfoliating bark of large, often dead, trees” 25

to

37) clomazone is not expected to adversely affe ct aquatic invertebrat es. Since birds are characterized as “nomadic,” 23 it does not appear as if this species has localized populati Therefore, EFED agrees that the effects dete rmination for this species should be NLAA.
The Florida Department of Agriculture in dicated 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 determinatio n for small to la

c lim ited 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 w ith 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 in dicated 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/expl orer/servlet/NatureServe?search Name=Drymarchon+corais+couperi 23 http://www.natureserve.org/explor er/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 35E FED response: For non-rice uses of clomazone, the effects determinatio n 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-s pecific comments that were provided. Cape Sable seaside sparrow – “This species and all available hab itat currently found only ) 27 .”

onal

in

(FNAI 2000).” ine rockland in Dade County.” 00).” ary – “All known populations are on pine plantations and utility

lat woods 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, car nivores is NLAA. LAA determinations are fo r 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, ma mmal 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 t he Everglades National Park and Big Cypress National Preserve (FNAI 2000

- Florida grasshopper sparrow – “Clomazone dr ift not expected to significant damage (reduce food or cover) dry prairie habitat that requires frequent burning. All known populations occur on state and fede ral 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 sava nnah 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 ma naged p

- Chapman rhododendron – “All populations are on private timber lands (FNAI 20

- Apalachicola rosem

r ights-of-way (FNAI 2000).”

- Florida skullcap – “Found in wet pine f A palachicola National Forest (FNAI 2000).”

- Telephis spurge – “All plants are within four miles of th e coast in the panhandle of F lorida (FNAI 2000). Most occurrences are on private timberlands a nd utility rights-o way.”

- Anastasia Island beach mouse – “Most of Anas tasia Island is in residential developmen (FNAI 2000).”

- Choctawatchee beach mouse - “Prot ected on state parks (FNAI 2000).”

- Southeastern beach mouse – “Most are f ound on protected federal lands (FNAI 2000).”

- Florida

E

FED response: Cl b ecause non-rice crops for which it is register ed are grown throughout the s h abitats 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 Inve ntory (FNAI). Field Guide to the Rare An imals of Florida. 2001. www.fnai.org. Page 34 of 35Page 35 of 35 e, clomazone may be deposited on areas inhabite d by these listed species. The effects a

ffected due to offsite transport of clomaz one, primarily via volatilization. Therefor
determinations for these species should remain LAA.