Docket Number: EPA-HQ-OPP-2007-0111 www.regulations.gov



### TABLE OF CONTENTS

Page #

I. Final Work Plan (FWP) 3

II. Revised Ecological Risk Assessm ent Problem Formulation 8

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I. FINAL WORK PLAN

Introduction:

This is EPA’s Final Work Plan for the registration review of fenoxycarb. The work plan includes the expected registration review time line. The work plan also addresses public

comments on the Preliminary Work Plan in the Summary Document posted in the initial registration review docket, or any othe r comments on the initial docket. The Summary

Document provided information on what EPA knows about the pesticide and what additional risk analyses and data or information the Agen cy believes are needed to make a registration

review decision.

The Agency is implementing the new registration review program, and plans to review each registered pesticide every 15 years to determ ine whether it continues to meet the FIFRA standard for registration. Changes in science, public policy, and pestic ide use practices will occur over time. The registration review program is intended to make sure that, as the ability to assess risk evolves and as policies and practices change, all registered pesticides continue to meet that statutory standard. The public phase of registration review be gins when the initial docket is opened for each case. Inform ation on this program is provided at: http://www.epa.gov/oppsrrd1/registration_review

.

Based on public comments, the Fenoxycarb Final Wo rk Plan has been modified slightly from the Fenoxycarb Preliminary Work Plan. First, the ecological Problem Formulation has been revised so that all fenoxycarb labe ls are included in its Table 1. Second, justifications for the required ecological studies have been include d in the ecological Problem Formulation.

In addition, the Final Work Plan has been revised to clarify that two stud ies will be required to

conduct the human health assessment: a develo pmental toxicity test and a multi-generation reproductive toxicity test in ra ts. In lieu of conducting thes e two separate studies, the study requirements can be satisfied by an extended 1-genera tion toxicity test in rats. If this approach is chosen, registrants should consult the Agency on the study design, including seeking protocol approval, prior to the conduct of th e study. The HED Registration Review Problem

Formulation document has not been revised a nd is the same as was presented in the Fenoxycarb Preliminary Work Plan.

Risk Assessment and Data Needs: Ecological Risk:

• The Agency anticipates conducting a comp rehensive ecological risk assessment, including an endangered species assessm ent, for all fenoxycarb uses.

• The planned ecological risk assessment will allow the Agency to determine whether fenoxycarb’s use has "no effect" or "may affect" federally lis ted threatened or endangered species (listed species) or their desi gnated critical habitat. If the assessment indicates that fenoxycarb "may affect" a listed species or its designate d critical habitat, the assessment will be refined. The refined assessment will allow the Agency to determine whether use of fenoxycarb is “lik ely to adversely affect” the species or critical habitat or "not likely to adversely a ffect" the species or critical habitat. When an assessment concludes that a pesticide's use "may affect" a listed species or its

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designated critical habitat, the Agency w ill consult with the U.S. Fish and Wildlife

Service and/or National Marine Fisheries Se rvice (the Services), as appropriate.

• The Agency needs the following data in order to complete these assessments:

o 850.2300 Avian Reproduction Test

o 870.3800 Chronic Mammalian Toxicity Test (could be satisfied by an extended one-generation reproduction study)

o 850.4250, 850.4225 Terrestrial Plant Toxicity Tests

o 850.4400 Aquatic Plant Toxicity Tests

• Please refer to the Section II of this docu ment, Problem Formulation for the Ecological Risk Assessment of Fenoxycarb,” for a deta iled discussion of the anticipated risk assessment needs (p. 8). This revision re places the ecological Problem Formulation that was presented in the Preliminary Work Plan for Fenoxycarb.

Human Health Risk:

• Fenoxycarb’s registered uses are all non f ood uses. Fenoxycarb has turf and other outdoor uses which could lead to exposure th rough drinking water. The Agency plans to complete a drinking water assessment for fenoxycarb.

• A review of the toxicity data base will be undertaken to determine whether there is an appropriate incidental oral endpoint for residential risk assessment. No residential handler or post application risk assessments have been conducted on fenoxycarb. The Agency plans to assess reside ntial handler and po st application exposure and risk as part of the Registration Review process. If products intended for use by residential handlers are cancelled, then a residential handler risk assessment would not be

conducted.

• The Agency may conduct an aggregate a ssessment for drinking water exposure and

residential uses.

• The Agency plans to conduct an occupationa l handler exposure and risk assessment to address dermal exposure from the agricu ltural use of fenoxycarb. An occupational handler assessment for inhalation exposure has been previously conducted for the agricultural fenoxycarb uses. The Agency pl ans to conduct an occupational handler dermal and inhalation exposure and risk asse ssment for the turf and greenhouse uses of fenoxycarb.

• The Agency plans to conduct an occupa tional post application exposure and risk assessment for all existing uses of fenoxycarb.

• The Agency needs the following data in order to complete these assessments:

o 870.3800 Chronic Mammalian Toxicity Test

o 870.6300 Developmental Neurotoxicity Test

o In lieu of conducting these two separate studies, the registrant may consider conducting an extended 1-generation toxici ty study in rats as described by Cooper et.al . (2006) 1 . If this approach is chosen, EPA strongly encourages the registrant to consult the Agency on th e study design, including seeking protocol approval from EPA, prior to the conduc t of the study. Should the extended 1-

1 Cooper, et.al. (2006) “A Tiered Approach to Life-Stages Testi ng for Agricultural Chemical Safety Asessment”

Crit. Rev. Toxicol. 36 (1): 69-98

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generation reproduction study find othe r effects that require further investigation, EPA would consider the need for additional studies.

• Please refer to the “Fenoxycarb Summary Document – Registration Review: Initial Docket (August 1, 2007), Section IV – Huma n Health Effects Scoping Document” for a detailed discussion of previous human health assessments (Document ID: EPA-HQOPP-2006-0111-0007 ).

Timeline: EPA has created the following estimated ti meline for the completion of the fenoxycarb registration review.

Activities Estimated

Month/Year Opening Docket
Open Public Comment Period for Fenoxycarb Docket July 2007

Close Public Comment Period September 2007
Case Development

Develop Final Work Plan (FWP) 2007 – Oct.-Dec.

Issue DCI 2008 – Jul.-Sept.

Data Submission 2011 – Jul.-Sept.

Open Public Comment Period for Preliminary Risk Assessments 2012 – Oct.-Dec.

Close Public Comment Period 2012 – Oct.-Dec.

Registration Review Decision
Open Public Comment Period for Proposed Reg. Review Decision 2013

Close Public Comment Period 2013 Final Decision and Begin Post-Decision Follow-up 2013 Total (years) 6

Summary of Comments Receive d During Docket Opening: The fenoxycarb registration review docket wa s open for a 60-day comment period beginning on August 1, 2007. During that time, several comm ents were received. They are summarized below. These comments, which are addressed in this document, did not change the work plan or timeline set out in the preliminary work pla n. Further, this document makes final the work plan for the fenoxycarb registration review process.

Summary of Comments from FIFRA Endangered Species Task Force (FESTF)

1. Comment: The FIFRA Endangered Species Task Force (FESTF) submitted a comment that the Agency should ensure any company who is a registrant for fenoxycarb, but not a member of the FEST F (or a company having met its data compensation obligations) provide a formal o ffer-to-pay to FESTF in conjunction with their support of the active ingredient. Th e primary registrant of fenoxycarb products, Syngenta, is a FESTF member and is entitled to rely on FESTF data.

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Response: The Agency thanks FESTF for its comment and will consider this information as it conducts the registration review and makes its registration review

decisions.

Summary of Comments from Syngenta Crop Protection

2. Comment: Syngenta submitted a voluntary cance llation request for several of their fenoxycarb products. Syngenta intends to ma intain the following registrations: 100-722 and 100-723. Syngenta has requested voluntary cancellation of the following registrations: 100-725, 100-746, 100-750, 100-753, and the outstanding experimental use permits that remain active in EPA databases. Response: These requests for voluntary cancella tion will be published in the Federal Register. As long as re gistrants do not withdraw their requests for voluntary cancellation, and no other group notifies EPA that they would lik e to support the product, the products will be cancelled at the end of the comment period.

3. Comment: Syngenta is only supporting produc t 100-722, Award Fire Ant Bait, and product 100-723, Fenoxycarb Technical. Syngenta notes that cancellation of the residential-use fire ant products will elimin ate the need to conduct a consumer handler

risk assessment for the fire ant use of fenoxycarb. Syngenta has also requested voluntary cancellation of its only fenoxycar b wettable powder product (100-750). If other registrants with similar products requ est voluntary cancellation for their products,

EPA will not need to assess the risk a ssociated with this type of product. Response: The Agency thanks Syngenta for its comment, and will consider the affect that those product cancellati ons will have on the risk assessment scenarios.

4. Comment: The only end-use fenoxycarb registrati on that Syngenta intends to maintain is 100-722, a granular product for use by commerci al workers for fire ant infestations.

Fire ants are limited to areas of the Southe rn U.S., so the extent of fenoxycarb use is

limited. Response: The Agency thanks Syngenta for its comment and will consider this information as it conducts the registration review and makes its registration review

decisions.

Summary of Comments from SC Johnson, Un ited Industries Corp., and Whitmire MicroGen

5. Comment: EPA has received voluntary cancellation requests from SC Johnson for products 4822-292 and 4822-442. Both products are indoor residential use products that had not been marketed by th e company for several years. Response: These requests for voluntary cancella tion will be published in the Federal Register. As long as re gistrants do not withdraw their requests for voluntary cancellation, and no other group notifies EPA that they would lik e to support the product, the products will be cancelled at the end of the comment period.

6. Comment: United Industries Corp. indicated to EPA that it plans to cancel product 8660-156, a granular for applica tion to golf courses and sod farms, via non-payment of

maintenance fees.

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Comment: Whitmire Micro-Gen indicated to EP A that it plans to cancel product 499- 375, a total release fogger for use in gr eenhouses, via non-payment of maintenance

fees. Response: If the companies cancel their pr oducts as indicated, EPA will publish a Federal Register Notice cancelling the produc ts through non-payment of maintenance

fees.

Next Steps: Ecological and human health risk assessments will be conducted, as detailed in the Risk

Assessment and Data Needs Section above. As not ed previously, the Agency will require four studies through the data call-in process in order to conduct complete human health and ecological risk assessments, including an e ndangered species assessment for all uses

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON D.C., 20460

PC Code: 125301

DP Barcode: D337398 December 12, 2007

MEMORANDUM

Subject: Registration Review – Problem Formula tion for the Ecological Risk Assessment of Fenoxycarb (revised from July 24, 2007 version due to addition of labels in Table 1)

To: Katie Weyrauch, Chemical Review Manager Re-registration Branch 7508 P Special Review and Re-registration Division Office of Pesticide Programs

From: Marie Janson, Environmental Scientist James Lin, Ph. D., Environmental Engineer

Environmental Risk Branch 1

Environmental Fate and Effects Division 7507 P Office of Pesticide Programs

Through: Nancy Andrews, Ph.D., Branch Chief Thuy Nguyen, RAPL

Environmental Risk Branch 1

Environmental Fate and Effects Division 7507 P Office of Pesticide Programs

Attached is the problem formulation for the ecological risk assessment to be conducted as part of the Registration Review of the insect growth regulator, fenoxycarb. This problem formulation was revised from the July 24, 2007 version to add additional labels to Table 1.

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## R EGISTRATION 

## R EVIEW



## E COLOGICAL 

## R ISK 

## A SSESSMENT



## P ROBLEM 

## F ORMULATION FOR 

## :



## F ENOXYCARB

Ethyl (2-[4-phenoxyphenoxy]ethyl) carbamate

P REPARED B Y :

Marie Janson, Environmental Scientist James Lin, Environmental Engineer
Environmental Risk Branch 1
Environmental Fate and Effects Division Office of Pesticide Programs

A PPROVED B Y :

Nancy Andrews, Ph.D., Chief
Environmental Risk Branch 1
Environmental Fate and Effects Division Office of Pesticide Program

December 12, 2007

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### S TRESSOR 

### S OURCE AND 

### D ISTRIBUTION

Fenoxycarb is an insecticide (or gr owth regulator) that disrupts the development of the pest. Fenoxycarb has an insect-specific mode of acti on exhibiting strong juveni le hormone activity. It inhibits metamorphosis to the adult stage, induces interference with the molting of early instar larvae, and produces certain ovicide and delayed larvicide adulticide effects in various insect species. Fenoxycarb is used as an insec ticide, miticide, insect growth regulator, sex attractant or feeding stimulant to control fire ants, big-headed ants, white flies, soft scales, fungus gnats, thrips, shore flies and lepidopterous leaf miners.



### I NTEGRATION OF 

### A VAILABLE 

### I NFORMATION

The risk assessments available in the docket, and which serve as the basis for this problem formulation, include the following:

• (1996) DP Barcode D223481 Memorandum: Review of proposed new use of fenoxycarb (Logic Fire Ant Bait) on forage hay and grasses.

• (1996) Comprehensive environmental fate a nd ecological review for re-registration of new uses of fenoxycarb as a 40% WP on pome fru its and tree nuts, and as a fire ant bait for use on forage hay, grass and citrus.

• Section 18 (1996) specific exemptions for use of fenoxycarb to control pear psylla on pear s in Oregon and Washington 25% WP

• July 9, 1997 review of the Novartis letter, dated 3/ 24/1997, which responds to the EFED review of the proposed use of Logi c Fire ant bait on c itrus, dated 12/12/1996.



### E COLOGICAL 

### E FFECTS

T OXICITY S TUDIES

The available acute toxicity data on the active ingredient indicate that fenoxycarb is practically non-toxic to birds (LD 50 >3000 mg/kg; LC 50 = 11,574 ppm), practically non-toxic to small mammals (LD 50 >16,800 rat), moderately toxi c to freshwater fish (LC 50 = 1.6- 1.86 ppm), highly toxic to freshwat er invertebrates (LC 50 = 0.4 ppm), highly toxic to estuarine/marine fish (LC 50 = 1.07 ppm), and highly to moderately toxi c to estuarine/marine invertebrates (LC 50 or EC 50 = 0.15 – 2.2 ppm).

No toxicity studies were submitted for aquatic pl ants, terrestrial plants, chronic birds, chronic

estuarine marine fish and chronic estuarine ma rine invertebrates. For chronic mammal study, a

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two generation rat reproduction study was submitte d to the Agency; however in the absence of liver toxicity information on parental animals and the presence of decr eased pup weight in all dose groups, the parental and offspring NOAEL c ould not be established, and the study was deemed unacceptable by the HIARC committee on 12/22/1997. Since the decreased pup weight occurred at the lowest dose group of 200 mg/kg-diet, EFED used an LOAEL of 200 mg/kg-diet to assess chronic risks to mammal s. Furthermore, based on a developmental (teratology) rabbit study, a NOA EL of 100 mg/kg-bw based on decreased body weight gain and NOAEL of 200 mg/kg-bw for incidence of fe tal malformation (spina bifida) along with hypoplastic tail were established. The NOAEL va lues from the developmental (teratology) rabbit study were not selected for toxicity endpoints because the above rat reproduction study values were more sensitive for exposure of fenoxycarb in dietary administration. Uncertainty exists with this value, however because a NOAEL was not established therefore exceedences

are underestimated.

I NCIDENT R EPORTS

The Agency has reviewed incident reports in the Ecological Incident Information System (EIIS) for adverse effects to fish or wildlife that were attributed to fenoxycarb use. The Agency has received one report of adverse field effects to non-target anim als that was linked to use of fenoxycarb. In 2000, mortality of a pproximately 100 catfish occurred in a pond in Texas following application of fenoxycarb and abamectin adjacent to the pond. Although the incident was likely related to runoff of these pe sticides during a rain event, the Agency does not know if the mortality was caused by e xposure to fenoxycarb or abamectin, or a combination of the two. This is the only major incident reported to the Agency linking fenoxycarb use to any adverse effects to non-target animals or plants. Aggregate reports from the registrants, however, have identified six minor incidents of adverse effects to plants and

one minor incident of adverse effects to a non-ta rget invertebrate. The Agency has received no incident report from pesticide registrants concerning fenoxycarb contamination of ground or

surface water.

A lack of reported incidents does not necessarily mean that such incidents have not occurred. In addition, incident reports for non-target plan ts and animals typically provide information on mortality events only. Reports for other adverse effects, such as reduced growth or impaired reproduction, are rarely received.



### E XPOSURE 

### C HARACTERISTICS

The guideline laboratory data indi cate that fenoxycarb is moderate ly persistent in soil. In sandy loam soil, aerobic and anaerobic degrad ation of fenoxycarb was found to follow biphasic kinetics. The primary half-life for aerobic de gradation was determined to be 6.7 hours and the secondary half-life value was cal culated to be 8.2 months. Th e primary anaerobic half-life was calculated to be 16 days and th e secondary half-life value was calculated to be 8.5 months. Based on batch equi1ibrium, column leaching an d terrestria1 field dissipation data, fenoxycarb

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appears to have a little pote ntial for movement into groundw ater, except on soils with low organic matter and high sand content.

Fenoxycarb has a potential to reach surface water through runoff, erosion and spray drift, when applied to the treated fields. In aquatic en vironment, fenoxycarb is st able to hydrolysis and moderately photolytic persistent with aqueous photolysis half-lives of 18 – 23 days. Based on the aerobic aquatic metabolism half-lives of 3.9 days in the water system alone and 18.8 days in the combined sediment and water system, fe noxycarb is not expected to be persistent.

In the terrestrial environment, fenoxycarb has a potential to reach non-target organisms through runoff, erosion and spray drift, following appli cation to the treated fi elds. Fenoxycarb appears to dissipate in terrestrial ecosystems through a microbially -mediated process including chemical transformations with subsequent mineralization. However, under an anaerobic terrestrial environment, fenoxycar b is more persistent. In a ddition parent fenoxycarb binds to soi1, so its mobility should be 1imited. Due to th e low Henry’s Law constant with solubility of 5.66 ppm and vapor pressure of 6.5 x 10 -9 mm Hg, the volatilization e ffects are expected to be minimal. With a BCF of 95, the bioaccumu lation is not expected to be a problem.



### C HARACTERISTICS OF 

### E COSYSTEMS 

### P OTENTIALLY AT 

### R ISK

For fenoxycarb, the ecosystems at greatest risk are those in close proximity to the use areas. These would include new fields (surrounding non- agricultural terrestrial habitats) and water bodies directly adjacent to treated fields that may receive chemical residues via drift and/or runoff. Within water bodies, the water column, sediments, and pore water are all compartments of concern. The use sites that fenoxycarb are used on are; home lawns, ornamentals, nurseries, sod farms, horse farms, turf, certain non-bearing citrus crops, and other non-agricultural land. A single appl ication (dust, granular, pre ssurized liquid, wettable powder) is made at rates ranging from 0.015 – 0.174 lb s. a.i./acre, depending on the use site. Application methods used are single mound treatment, broadcas t and aerial application. Organisms of concern include birds, mammals, reptiles, fish, and terrestrial and aquatic invertebrates, plants, and amphibians. The assessment endpoints are intended to reflect population sustainability and community structure within ecosystems and hence relate back to ecosystems at risk. If risks are expected fo r given species/taxa base d on the screening-level assessment, then risks might be expected to translate to higher levels of biological organization.

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### A SSESSMENT 

### E NDPOINTS

Assessment endpoints are defined as “explicit expr essions of the actual environmental value that is to be protecte d.” Defining an assessment endpoint involves two st eps: 1) identifying the

valued attributes of th e environment that are considered to be at risk; and 2) operationally defining the assessment endpoint in terms of an ecological entity (i.e., a community of fish and aquatic invertebrates) and its attr ibutes (i.e., survival and reproduc tion). Therefore, selection of the assessment endpoints is based on valued entit ies (i.e., ecological receptors), the ecosystems potentially at risk, the migration pathways of pesticides, and the routes by which ecological receptors are exposed to pesticide-related cont amination. The selection of clearly defined assessment endpoints is important because they provide direction and bou ndaries in the risk assessment for addressing risk management issues of concern. Changes to assessment endpoints are typically estimated from the available toxicity st udies, which are used as the

measures of effects to charac terize potential ecological risks associated with exposure to a pesticide, such as fenoxycarb.

To estimate exposure concentra tions, the ecological risk as sessment considers a single application at the maximum application rate to fields that have vulnerable soils. The most sensitive toxicity endpoints are used from surroga te test species to estimate treatment-related direct effects on acute mortality and chronic reproductive, growth and survival assessment endpoints. Toxicity tests are intended to determine effects of pesticide exposure on birds, mammals, fish, terrestrial and aquatic invertebrate s, and plants. These te sts include short-term acute, sub-acute, and reproduction st udies and are typically arranged in a hierarchical or tiered system that progresses from basic laboratory tests to applied field studies. The toxicity studies are used to evaluate the potential of a pesticid e to cause adverse effect s, to determine whether further testing is required, and to determine th e need for precautionary label statements to minimize the potential adverse effects to non-target animals and plants. However, the previous assessments did not evaluate toxicity to aquatic plants, terrestrial plants, chronic toxicity to birds and chronic toxicity to mammals due to lack of available data.

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### C ONCEPTUAL 

### M ODEL

In order for a chemical to pose an ecologica l risk, it must reach ecological receptors in biologically significant concen trations. An exposure pathway is the means by which a pesticide moves in the environment from a source to an ecological receptor. For an ecological exposure pathway to be comple te, it must have a source, a release mechanism, an environmental transport medium, a point of exposure for ecological receptors, and a feasible route of exposure.

The conceptual model ( Figure 1 ) depicts the potential pathways for ecological risk associated with fenoxycarb use. The conceptual model pr ovides an overview of the expected exposure routes for organisms within the fenoxycarb action area. For terrest rial organisms, one route of exposure considered is the dietar y route; consumption of food items such as plant leaves that have fenoxycarb residues as a resu lt of spraying and drift. An a dditional route of exposure for terrestrial organisms is the direct uptake of granules from granul ar applications of fenoxycarb. For aquatic animal species, the major routes of exposure are considered to be via the respiratory surface (gills) or the integument. Di rect contact and/or root uptake is the major route of exposure for terrestrial and wetland (r iparian) plants, while aquatic plants may be exposed via direct uptake and adsorption. Estima ted exposure concentrations for all organisms are obtained through the use of se veral Agency exposure models.

R ISK H YPOTHESIS

Based on an examination of the physical/che mical properties of fenoxycarb, the fate and disposition in the environment, and mode of application, a c onceptual model was developed that represents the possible relationships betw een the stressor, ecological receptors, and the assessment endpoints. Major routes of di ssipation for fenoxycarb are soil (aerobic and anaerobic) binding and aerobi c aquatic metabolism to CO 2 which results in exposure to various terrestrial and aquatic receptors.

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F IGURE 1. E COLOGICAL CONCEPTUAL DIAGRAM FOR F ENOXYCARB

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### A NALYSIS 

### P LAN 

### O PTIONS

In Registration Review, pesticide ecological risk assessments will follow the Agency’s Guidelines for Ecological Risk Assessment, will be in compliance with the paper titled “Overview of the Ecological Risk Assessment Process in the Office of Pesticide Programs, U.S. Environmental Protection Agency” (“Over view Document”) (January 2004), and will be

done in accordance with Section 7 of the Endangered Species Act.

Previously completed screening level risk asse ssments and exceedences of Agency levels of

concern indicate a need to further examine and re fine acute risk to terrestrial and aquatic nonvascular plants. Potential chronic risks to sma ll medium and large-sized birds will be assessed when additional toxicity data is submitted. Pote ntial chronic risks to small medium and largesized mammals are uncertain with current toxi city data submitted. Finally, analysis of potential indirect effects on listed species is required.

The Agency wishes to better understand 1) whic h environmental and product specific factors

contribute most to the off-site movement and phytotoxicity of fe noxycarb, 2) risks to terrestrial and aquatic plants 3) the effectiven ess of buffer restricti ons, and 4) options for additional mitigation, where required 4) chroni c risks to birds and mammals 5) Incident information would be extremely helpful in unders tanding the current situation with regards to potential risk to non- target species.

Table 1 shows the current status of risk assessmen ts for registered uses of fenoxycarb. In addition to refining the ecological risk assessm ent, other uncertainties and potential paths

forward are described below.

• No assessment of risks to terr estrial and aquatic risks to plants was done in previous assessments due to lack of submitted toxicity studies. Therefore, these studies

would be of value to assess risks to terrestrial and aquatic plants.

• Previous assessments did not evaluate ch ronic reproductive risks to mammals. A two generation rat reproduction study wa s submitted to the Agency, however a parental and offspring NOAEL could not be established. Decreased pup weight occurred at the lowest dose group of 200 mg/kg-diet. EFED w ill use the LOAEL of 200 mg/kg-diet based on decreased pup wei ght to assess chronic risks to mammals

due to lack of available ch ronic reproductive toxicity data . Uncertainty exists with this value, however because a NOAEL was not established therefore exceedences are underestimated. In addition, no chronic reproductive toxicity studies for birds were submitted to the Agency. However, based on previous assessments unreviewed toxicity data regarding possible chroni c reproductive effects of fenoxycarb to avian life reported the NOEL values to be 160 ppm for mallard duck and 400 ppm for bobwhite quail. When th ese NOEL values are modeled in the TREX terrestrial model with application rates of 0.015 lb ai/A and 0.136 lb ai/A, 2 applications, 14 day intervals, and a 35 day half-life, no chronic exceedences occurred with chronic RQs values ranging from 0.001 to 0.40. However, the unreviewed toxicity study in which the above NOEL values were derived was not

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identified in the previous assessments. Ther efore, these values can not be verified. Also, no analogs for fenoxycarb were identified by EFED to estimate chronic reproductive toxicity values for birds or mammals. Also, based on the exposure and risk characterization (MRID 438295-03) , fenoxycarb is an insect growth regulator which is a “hormone analog th at interferes with the normal juvenile hormone titre and therefore molting, maturation and reproduction. In fire ants it has been shown to suppress the growth of follicular epithelium, nurse cells and cytoplasm/yolkplasm and cause resorption of eggs.” In addition to target organisms it has been shown to impact the reproductive capability of the early life stage of

fish. It is not known how this mode of ac tion will express itsel f in higher organisms which produce eggs such as fish, reptiles, amphibians, birds and mammals. Since the freshwater aquatic in vertebrate shows signifi cant impacts on reproductive effects (RQ=112.5 for 0.015 lb ai/A applic ation rate) and modeling shows that exposure will occur for terrestrial organism s. Therefore, chro nic bird and mammal

studies would be useful in evalua ting risks to these organisms.

• A screening level assessment of acute and chronic risks to terrestrial and aquatic organisms has not been completed for all us es. Therefore, risks to these organisms require further evaluation.

• The tier I screening level assessment showed acute risk quotients for some fenoxycarb uses to be above levels of con cern for freshwater and estuarine/marine

fish and invertebrates. Since these assessments were conducted using tier 1 exposure models on 0.015 lb ai/A, 0.125 lb ai/A and 0.31 lb ai/A, the Agency will refine the risk assessment by first estima ting EECs using tier II models. It is expected that the refinement will resu lt in lower or no LOC exceedences based on 0.015 lb ai/A and 0.136 lb ai/A appli cation rates for freshwater and

estuarine/marine fish and invertebrates.

• An assessment of chronic risk to estuarin e/marine invertebrates has been completed

based on acute to chronic ratios. Based on the acute and chronic data for freshwater invertebrates, and the acute data for estuarine/marine invertebrates, an

acute to chronic ratio can be calculated and applied in order to estimate the NOAEC

value for estuarine/marine invertebrates. Doing so results in a grass shrimp NOAEC of 0.006 ppb. There is some uncertain ty surrounding this estimated value,

however the acute to chronic ratio met hod is commonly used in these types of circumstances and is a reasonable approach using the best available data. For fenoxycarb, a NOAEC of 0.006 ppb for estuarine/ma rine invertebrates will be used in the risk assessment. The Agency doe s not believe a new study for estuarine marine invertebrates would change the overa ll risk conclusions because the toxicity values (daphnid LC 50 400 ppb, daphnid NOEC 0.0016 ppb and grass shrimp LC 50 220 ppb) used to derive the acute to chronic ratio method provide adequate

information.

• An assessment of chronic risk to estuarin e/marine fish has been completed based on

acute to chronic ratios. Based on the acute and chronic data for freshwater fish, and

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the acute data for estuarine/marine fish, an acute to chronic ratio can be calculated and applied in order to estimate the NOAEC value for estuarine/marine fish. Doing

so results in a silverside minnow NOAEC of 32.1 ppb. Th ere is some uncertainty surrounding this estimated value, however the acute to chronic ratio method is commonly used in these types of circumstances and is a reasonable approach using the best available data. For fenoxycarb, a NOAEC of 32.1 ppb for estuarine/marine

fish will be used in the risk assessment. The Agency does not believe a new study for estuarine marine fish would change the overall risk conclusions because the toxicity values (rainbow trout LC 50 1600 ppb, rainbow trout NOEC 48 ppb and

silverside minnow LC 50 1070 ppb) used to derive the acute to chronic ratio method provide adequate information

Data already collected in labor atory studies on fenoxycarb will be used as inputs to the tier I

AGDRIFT model. Should this a pproach prove to be workable, the results of this modeling exercise may be used to evaluate the buffer di stances when LOC exceedences occur from spray applications of fenoxycarb.

If the planned ecological risk assessment continues to indicat e that fenoxycarb may potentially impact, either directly or indire ctly, listed species or critical habitat, and therefore does not support a “not likely to adversely affect” determination, further refinements will be made. This will involve determining whether use of fenoxycar b “may affect” a particular listed species, and if so, whether it is “likely to adversely affect” the species, or in the case of critical habitat, whether use of the pesticide may destroy or adversely modify any principle constituent elements for the critical habitat, and if s o, whether the expected impacts are “likely to adversely affect” the critical habita t. The first step in the process is to improve the exposure estimates based on refining the geographic proximity of fenoxycarb’s use and the listed species

and/or critical habitat. If there is no geographic proximity, this information would support a determination that fenoxycarb use wi ll have no effect on the species or critical habita t. If after conducting the first step of this analysis the Agency determines that geographic proximity exists, both potential direct effects and any potential indirect effects of the pesticide use will be examined. This process is consistent with the Agency's Overview Document. The Agency will consult as necessary with the U.S. Fish and Wildlife Service and National Marine Fisheries Service (Services), consiste nt with the Services' regulations.

If the screening level risk assessment identifies potential concerns for indirect effects on listed species for those organisms dependent upon birds, fish and aquatic inve rtebrates and possibly terrestrial or aquatic plants depending on new toxicity data submitted, the next step for EPA and the Services would be to identify which liste d species and critical habitat are potentially implicated. Analytically, the identification of such species and critical habitat can occur in either of two ways. First, the agencies could determine whether the action area overlaps critical habitat or the occupied range of any listed species. If so, EPA would examine whether fenoxycarb’s potential impacts on non-endangered species would affect the listed species indirectly or directly affect a constituent element of the critic al habitat. Alternatively, the agencies could determine which listed speci es depend on biological resources, or have constituent elements that fall into, the taxa th at may be directly or indirectly impacted by

18Docket Number: EPA-HQ-OPP-2007-0111 www.regulations.gov

fenoxycarb. Then EPA would determine whether the use of fenoxycarb ove rlaps the critical habitat or the occupied ra nge of those listed species.

A NTICIPATED D ATA N EEDS The Agency foresees requiring the following addi tional ecological effects data: terrestrial and aquatic plants, chronic ma mmal, and chronic bird. The Agency will however conduct a search of th e open literature to ensure that all best available science is utilized. The Agency us es the ECOTOX database as its mechanism for searching the open literature fo r ecological effects informati on. ECOTOX integrates three previously independent data bases - AQUIRE, PHYTOTOX, and TERRETOX - into a system which includes toxicity data derived predomin ately from the peer-reviewed literature, for aquatic life, terrestrial plants, and terrestrial wildlife, respectively.

O THER I NFORMATION N EEDS

There is specific information that will assist the Agency in refini ng the ecological risk assessment, including any species-specific effect s determinations. The Agency is very much interested in obtaining the following information:

1. confirmation on the following label information

a. sites of application

b. formulations

c. application methods and equipment

d. maximum application rates

e. frequency of application, applicati on intervals, and maximum number of applications per season

f. geographic limitations on use

2. use or potential use distributi on (e.g., acreage and geographica l distribution of relevant crops)

3. use history

4. median and 90 th percentile reported use rates (lbs. a. i./acre) from usage data – national, state, and county

5. application timing (date of first applica tion and application intervals) by crop – national, state, and county

6. sub-county crop location data

7. usage/use information for non-agricultural us es (e.g., forestry, resi dential, rights-ofway)

8. directly acquired county-level usage da ta (not derived from state level data)

a. maximum reported use rate (lbs. a.i./acre) from usage data – county

b. percent crop treated – county

c. median and 90 th percentile number of applications – county

d. total pounds per year – county

e. the year the pesticide was last us ed in the county/sub-county area

f. the years in which the pesticide was applied in the county/sub-county area

9. typical interval (days)

10. state or local use restrictions

19Docket Number: EPA-HQ-OPP-2007-0111 www.regulations.gov

11. ecological incidents (non-target plant damage and avian, fish, reptilian, amphibian and mammalian mortalities) not alr eady reported to the Agency

12. monitoring data

The analysis plan will be revi sited and may be revised dependi ng upon the data available in the open literature and the information submitted by the public in response to the opening of the Registration Review docket.

20Docket Number: EPA-HQ-OPP-2007-0111 www.regulations.gov

T ABLE 1
C URRENT S TATUS OF E COLOGICAL R ISK A SSESSMENT F OR R EGISTERED U SES OF F ENOXYCARB ( USE INFORMATION BASED ON LABLES )

Use Reg.

number Product

Name Application rate (lbs. a.i./A) Method of application Included in

Previous EFED Screening Risk

Assessment? LOC’s Exceeded in Tier I Screening Risk Assessment (?: not determined) RQ is in parenthesis Fire Ant and Big

Headed Ants in ornamentals, home lawns and landscaped areas around home, non-crop areas, horse farms, sod farms, non-grazed areas on farm, nurseries and

fire ants in certain nonbearing crops 100-722 Award ® Fire Ant Bait, Logic® Fire Ant Killer (CA only) 0.015 (retreatment may

be desirable after 3 – 4 months) granular (single mound,

broadcast and aerial) Yes Birds: ? chronic

Mammals: ? chronic

Terrestrial Plants: ?

Freshwater Fish: none

Freshwater Invertebrates: chronic(112.5)

Estuarine/Marine Fish: none E-M Invertebrates: chronic(30) Aquatic Plants: ?

Manufacturing

use 100-723 Fenoxycarb

Technical N/A N/A N/A N/A

Turf fertilizer and fire ant and Big Headed Ant bait to golf

courses and sod

farms 8660-

156 Polyon Turf

Fertilizer

award Fire Ant

Bait 0.0079 (retreatment may

be desirable after 3 – 4 months) granular (broadcast ) N/A Ecological effects acute and

chronic not assessed from previous risk assessments

Greenhouses 499-375 Whitmire PT

2100

Preclude

IGR Insect

Growth Regulator N/A aerosol No This is for in-door greenhouse use only.

Greenhouses 499-437 Whitmire PT®

2120 TR

Preclude® 0.174 aerosol No This is for in-door greenhouse use only.

Fire Ant Control , home lawns only and other non-crop land 100-725 Logic Fire ant

Killer* 0.0067 l (retreatment 7 days) Granular (broadcast and single mound) No Ecological effects acute and

chronic not assessed from previous risk assessments

Manufacturing

use 100-746 Fenoxycarb

1% Bait* N/A N/A N/A

For control of insects

in container and landscape ornamentals, nurseries, greenhouse ornamental crops and interiorscapes 100-750 Precision* 0.136 (retreatment 14 days outdoor applications) Wettable powder (chemigation,

overhead irrigation, spray, drench) No Ecological effects acute and

chronic not assessed from previous risk assessments

Manufacturing 100-375 Fenoxycarb N/A N/A N/A N/A

21Docket Number: EPA-HQ-OPP-2007-0111 www.regulations.gov

Use Reg.

number Product

Name Application rate (lbs. a.i./A) Method of application Included in

Previous EFED Screening Risk

Assessment? LOC’s Exceeded in Tier I Screening Risk Assessment (?: not determined) RQ is in parenthesis

use 25 WP* Bug infestation in home, pet area and on dogs 4822-

292 Raid Flea

killer IV Plus* N/A Aerosol spray N/A N/A

Flea infestation

occurs in home 4822-

442 Raid DOB* N/A dust N/A N/A

* proposed for cancellation

22Docket Number: EPA-HQ-OPP-2007-0111 www.regulations.gov

Guideline Number 850.2300 Study Title: Avian Reproduction

Rationale for Requiring the Data

No acceptable toxicity data was available fo r review for chronic risks to birds. Some

assessments included data from unreviewe d duck and quail reproduc tive studies which generated No-Observable-Effect-Levels ( NOEL) of 160 ppm and 400 ppm, respectively however, these studies can not be verified. Also, no analogs for fenoxycarb were identified by EFED to estimate chronic reproductive toxicity values for birds. Based on the exposure and risk characterization, fenoxycarb is an insect growth regulator which is a “hormone analog that interferes with the normal juvenile horm one titre and therefore molting, maturation and reproduction. In fire ants it has been shown to suppress the growth of follicular epithelium, nurse cells and cytoplasm/yolkplasm and cause reso rption of eggs.” It is not known how this mode of action will express it self in higher organisms which produce eggs such as fish, reptiles, amphibians, birds and mammals.

In addition to target organisms it has been show n to impact the reproductive capability of the early life stage of fish and aquatic invertebrates. For the freshwater aquatic invertebrate chronic RQs exceeded the LOCs with RQs= 112.5 for the 0.015 lb ai/A application scenario.

Mammals also showed reproductive effects in a developmental (ter atology) rabbit study, a NOAEL of 100 mg/kg-bw based on decreased body weight gain and NOAEL of 200 mg/kgbw for incidence of fetal malformation (s pina bifida) along with hypoplastic tail were

established.

The Agency has worked to finalize its update to the data requirements in 40 CFR part 158, which were promulgated in October 2007. No w two avian reproduction studies, one with a waterfowl and one with and upland game bird, are required to support all terrestrial use
patterns.

Practical Utility of Data

How did the agency make its registrat ion decision without this data?

To address potential risks previous assessments stated that avian repr oduction studies using the TGAI were not required for fenoxycarb becau se the following conditions are not met: 

### (1) birds may be subject to repeated or continuous exposure to the pestic ide, especially preceding or during the breeding season, 

### (2) the pesticide is stable in the environment to the extent that potentially toxic amounts may persist in animal feed, 

### (3) the pesticide is stored or accumulated in plant or animal tissues, and or, (4) in formation derived from mammalian reproduction studies indicates reproduction in terrestrial vertebrates may be adversely affected by the anticipated use of the product.

23Docket Number: EPA-HQ-OPP-2007-0111 www.regulations.gov

However, the above decisions do not include that short-term exposur es to pesticides can lead to significant adverse reproductive e ffects. In addition previous assessments did not identify chronic effects in other taxa such as; the pres ence of chronic mammalian effects in rabbits and reproductive effects in aquatic organisms.

Some assessments included data from unrevie wed duck and quail reproductive studies which generated No-Observable-Effect-Levels ( NOEL) of 160 ppm and 400 ppm, respectively however, these studies can not be verified.

How will the data be used? The avian reproduction studies are needed for fu ture regulatory decisions. The data would allow the Agency to quantify the potential fo r chronic risk, as measured by effects on reproduction and survival, from the use of fenoxycarb.

How could the data impact the Agency’s future decision-making? If future risk assessments are performed without this data, the Agency would have to assume that fenoxycarb “may effect” birds directly (and endangered species from other taxa indirectly), and use of fenoxycarb might need to be restricted in areas where endangered species could be exposed. The lack of these data will limit the flex ibility the Agency and registrants have in coming into compliance with the Endangered Species Act and could result in use restrictions for fenoxycarb which are unnecessarily severe.

24Docket Number: EPA-HQ-OPP-2007-0111 www.regulations.gov

Guideline Number 870.3800 Reproducti on and fertility effects Study Title: Mammalian Reproduction

Rationale for Requiring the Data

No acceptable toxicity data was available fo r review for chronic reproductive risks to mammals. Also, no analogs for fenoxycarb were identified by EFED to estimate chronic reproductive toxicity values for mammals.

For a chronic mammal study, a two generation rat reproduction study was submitted to the Agency, however a parental and offspring NOAEL could not be established. The HIARC

committee in 12/22/1997 concluded that in absen ce of liver toxicity information on parental animals and the presence of decreased pup we ight in all dose groups , the parental and offspring NOAEL could not be established ther efore, the study is considered unacceptable by HED. Decreased pup weight occurred at the lo west dose group of 200 mg/kg-diet. EFED will used the LOAEL of 200 mg/kg-diet based on decr eased pup weight to assess chronic risks to mammals due to lack of available chronic repr oductive toxicity data. In a developmental (teratology) rabbit study, a NOAEL of 100 mg/kg- bw based on decreased body weight gain and NOAEL of 200 mg/kg-bw for incidence of fe tal malformation (spina bifida) along with hypoplastic tail were established. The NOAEL va lues from the developmental (teratology) rabbit study were not selected for toxicity endpoints because the above rat reproduction study values were more sensitive for exposure of fenoxycarb in dietary administration. Uncertainty exists with this value, however because a NOAEL was not established therefore exceedences

are underestimated.

In addition to mammalian reproductive e ffects as described above fenoxcarb shows reproductive effects in other taxa as stated below:

• Based on the exposure and risk characteriz ation, fenoxycarb is an insect growth regulator which is a “hormone analog that interferes with the normal juvenile hormone titre and therefore molting, maturation and repr oduction. In fire ants it has been shown to suppress the growth of follicular epith elium, nurse cells and cytoplasm/yolkplasm and cause resorption of eggs.” It is no t known how this mode of action will express itself in higher organisms which produce eggs such as fish, reptiles, amphibians, birds

and mammals.

• In addition to the above target organisms it has been shown to impact the reproductive capability of the early life stage of fish and aquatic invertebrates. For the freshwater aquatic invertebrate chronic RQs exceeded the LOCs with RQs= 112.5 for the 0.015 lb ai/A application scenario.

Therefore, based on the above reproductive eff ects seen in mammals and other taxa, EFED requests a chronic reproductive mammalian toxicity test to assess chronic risks to mammals.

25Docket Number: EPA-HQ-OPP-2007-0111 www.regulations.gov

Practical Utility of Data

How did the agency make its registrat ion decision without this data? For previous assessments that included we ttable powders mammalian reproduction was not assessed and the mammalian reproduction study was listed as a data gap.

How will the data be used? The mammalian reproduction studies are needed for future regulatory decisions. The data would allow the Agency to quantify the potential for chronic risk, as measured by effects on reproduction and survival, from the use of fenoxycarb.

How could the data impact the Ag ency’s future decision-making? If future risk assessments are performed without this data, the Agency would have to assume that fenoxycarb “may effect” mammals directly (and endangered species from other taxa indirectly), and use of fenoxycarb might need to be restricted in areas where endangered species could be exposed. The lack of these data will limit the flex ibility the Agency and registrants have in coming into compliance with the Endangered Species Act and could result in use restrictions for fenoxycarb which are unnecessarily severe.

26Docket Number: EPA-HQ-OPP-2007-0111 www.regulations.gov

Guideline Numbers: 850.4250, 850.4225, 850.4400 Study Title: Seedling Emergence, Vegetative Vigor and Aquatic Pl ant Toxicity Tests

Rationale for Requiring the Data

No toxicity data was available for review for terrestrial or aquatic plants. No open literature data or data from analogs were available to assess terrestria l or aquatic plant toxicity for fenoxycarb. Based on the exposure and risk char acterization, fenoxycarb has a potential to reach surface water through runoff, erosion and drift when applied to the treated fields. Therefore, acute (listed and non- listed) potential risks to terrestrial a nd aquatic plants are uncertain from spray and granular applications of fenoxycarb.

In aquatic environment, fenoxycarb is stable to hydrolysis and moderately photolytic persistent with aqueous photolysis half- lives of 18 – 23 days. Based on the aerobic aquatic metabolism half-lives of 3.9 days in the water system alone and 18.8 days in the combined sediment and water system, fenoxycarb is not expected to be persistent.

Fenoxycarb appears to dissipate in terrestr ial ecosystems through a microbially-mediated process including chemical transformations with subsequent mineralization. However, under an anaerobic terrestrial environment, fenoxycar b is more persistent. In addition parent fenoxycarb binds to soi1, so its mobility should be 1imited.

The Agency has worked to finalize its update to the data requirements in 40 CFR part 158, which were promulgated in October 2007. Now, terrestrial and aquatic plant studies are required for insecticides due to possible phytotox ic effects and injury that insecticides may cause to non-target plants.

Practical Utility of Data How did the agency make its registrat ion decision without this data? Terrestrial and aquatic plant toxicity data we re not required for inse cticides in previous assessments, however since new Agency guideli nes were promulgated in October 2007 these studies are now required.

How will the data be used? The terrestrial and aquatic plant studies are need ed for future regulatory decisions. The data would allow the Agency to quantify the potential for acute and acute endangered species risk, as measured by effects on reproduction and survival, from the use of fenoxycarb. Liquid and granular applications will be assessed by EFED in future assessments. Therefore, the seedling emergence, vegetative vigor and aquatic plan t studies will be requested for exposure of fenoxycarb to endangered and non-endangered plan ts from runoff, erosion and drift.

How could the data impact the Agency’s future decision-making? If future risk assessments are performed without this data, the Agency would have to assume that fenoxycarb “may effect” terrestrial and a quatic plants directly (and endangered species

27Docket Number: EPA-HQ-OPP-2007-0111 www.regulations.gov

from other taxa indirectly), and use of fenoxycar b might need to be rest ricted in areas where endangered species could be exposed. The lack of these data will lim it the flexibility the Agency and registrants have in coming into co mpliance with the Endangered Species Act and

could result in use restrictions for fenoxycarb which are unnecessarily severe.

28