(freshwater and estuarine/marine) on an acute basis. No data were available to access toxicity or risk to plant species.

The major uncertainty in the environmental fa te database is the difference between the results in laboratory studies and in the field. There is also uncertainty with respect to the aquatic metabolism of fenpropathri n. Uncertainties also exist concerning the potential for adverse aquatic effects, including organisms living in the benthos, for acute, chronic and endangered species risk based on fate tr ansport involving drift and run-off, and persistence. There is uncertainty concerning the potential for adverse terrestrial effects for acute and endangered species risk to terre strial organisms based on fate transport, drift, binding to the soil and persistence. In addition, th ere are ecological data gaps that
need to be addressed which increase uncertainti es in the risk picture for fenpropathrin.

2

# Environmental Fate and Ecological Risk
Assessment Problem Formulation in Support of Registration Review for Fenpropathrin

June 16, 2010



# Environmental Fate and Effects Division Office of Pesticide Programs US Environmental Protection Agency

3Prepared by: N.E. Federoff, Wildlife Biologist José L. Meléndez, Chemist

Secondary Review: Amanda Solliday, Biologist Keith Sappington, Senior Scientist

Branch Chief Mah T. Shamim, Ph.D.

Environmental Risk Branch V

4Table of Contents

1. Purpose

............................................................................................................................... ..... 6
2. Problem Formulation .............................................................................................................. 6 2.1 Nature of Regulatory Action ................................................................................................ 6
2.2. Previous Risk Assessments.................................................................................................. 7
3. Stressor Source and Distribution .......................................................................................... 10
3.1. Mechanism of Action ........................................................................................................ 12 3.2. Overview of Pesticide Usage ............................................................................................ 14 3.3. Environmental Fate and Transport .................................................................................... 18
3.4. Literature Search........................................................................................................ ....... 18
4. Receptors ............................................................................................................................... 31 4.1. Aquatic and Terrestrial Effects ......................................................................................... 31
4.2. Incident Database Review ................................................................................................. 22 4.3. Ecosystems Potentially at Risk ......................................................................................... 35 6. Conceptual Model .............................................................................................................. 36 6.1. Risk Hypothesis ............................................................................................................... 37 6.2. Conceptual Diagram ........................................................................................................ 37 7. Analysis Plan ..................................................................................................................... 40
7.1. Stressors of Concern ......................................................................................................... 41 7.2. Measures of Exposure ....................................................................................................... 41
7.3. Measures of Effect ............................................................................................................ 43 7.4. Integration of Exposure and Effects ................................................................................. 44
7.5. Deterministic and Probabilistic Assessment Methods ...................................................... 44 7.6. Endangered Species Assessments ..................................................................................... 44 7.7. Drinking Water Assessment ............................................................................................. 45 7.8. Preliminary Identification of Data Gaps ........................................................................... 46
7.8.1. Fate ............................................................................................................................. 46
7.8.2 Effects ......................................................................................................................... 51
8. References

............................................................................................................................... . 57 9. Bibliography........................................................................................ Appendix A. PRD data re quest justification tables .................................................................... 73

51. Purpose

The purpose of this problem formulation is to provide the foundation for the ecological risk assessment being conducted for the regist ered uses of fenpropathrin. As such, it articulates the purpose and objectiv es of the risk assessment, evaluates the nature of the problem, and provides a plan for analyzing th e data and characterizing the risk (EPA, 1998). Additionally, this problem formula tion is intended to identify data gaps, uncertainties and potential assumptions needed to address those uncertainties in characterizing the ecological risk associated with the registered uses of fenpropathrin. Fenpropathrin is a synthetic pyrethroid insect icide that is register ed for a variety of agricultural and non-agri cultural uses, includi ng head & stem bra ssica, citrus, cotton, cucurbit & fruiting vegetables, grapes, peanut , tree nut, stone & pome fruits, strawberries, bushberries, caneberries, currant, peas, olives , barley, tropical fruits, agricultural uncultivated areas, deciduous fruit trees, fore st trees, ornamental and/ or shade trees, ornamental herbaceous plants, ornamental non-flowering plants, and ornamental woody
shrubs and vines.

2. Problem Formulation

2.1. Nature of Regulatory Action

This report summarizes the Environmental Fa te and Effects Division’s (EFED) Problem Formulation for the Registration Review of fenpropathrin. Previous risk assessments were completed for the uses of the chemical, which serve as the basis for this assessment.

The Food Quality Protection Act of 1996 mandated the EPA to implement a new

program, i.e ., registration review ( http://www.epa.gov/oppsrrd1/registration_review/ ). All pesticides distributed or sold in the United States generally must be registered by the EPA. The decision to register a pesticide is based on the consideration of scientific data and other factors showing that it will not cause unreasona ble risks to human health, workers, or the environment when used as directed on product labeling. The registration review program is intended to ensure that, as the ability to assess risk evolves and as policies and practices change, all registered pesticides continue to meet the statutory
standard of no unreasonable adverse effect s to human health and the environment. Changes in science, public policy, and pest icide use practices will occur over time. Through the new registration review program , the Agency periodically reevaluates pesticides to make sure that as change o ccurs, products in the marketplace can be used safely.

As part of the implementation of the new Registration Review program pursuant to Section 3(g) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), the Agency is beginning its evaluation to determin e whether fenpropathrin continues to meet the FIFRA standard for regist ration. This problem formulati on for the environmental fate and ecological risk assessment chapter in suppo rt of the registration review is intended for the initial docket opening the pub lic phase of the review process.

62.2. Previous Risk Assessments, Scientif ic Advisory Panels and Background

Previous Assessments In 2008, EFED issued a risk assessment for the Section 3 registration of the new uses of fenpropathrin on bushberries, caneberries (Subgroup 13A), olives, currant, peas, fruiting vegetables, stone fruit, tree nuts and pistachio, certain trop ical fruits, and barley (DP Barcode 301100+). Single appl ication rates ranged from 0.2 to 0.4 lb a.i./A and seasonal application rates were 0.2 to 0.8 lb a.i./A/season. Prior to the assessment, the uses for fenpropathrin included cotton, grapes, peanuts, pome fruits, citrus, and strawberries, among others. The ecological risk assessmen t indicated chronic risk to birds and mammals, and acute and chronic risk to fish and aquatic invertebrate s. In addition, the risk quotients (RQs) exceeded the levels of concern (L OCs) for endangered species, including chronic RQs for bi rds and mammals, and acute and chronic RQs for aquatic organisms that live in the wa ter columns, and organisms living in the benthos. Due to the fact that birds are considered surrogates fo r reptiles and terrestrial phase amphibians and fish are surrogates for aquatic phase amphibi ans, the same risks were assumed for nonendangered and listed reptiles and amphibians. The risk profile was based on available ecotoxicity data and predicted environmental exposures. Fenpropathri n is toxic to bees, therefore, risk to beneficial insects was a ssumed. Toxicity to honeybees from residues on foliage suggested that fenpropathrin is toxi c and produces high mort ality to non-target
insects.

In the assessment, it was also concluded that fenpropathrin is resistan t to degradation in biotic and abiotic processes, but exhibited va riable persistence under field conditions. It had low mobility (hardly mobile, FAO 2000) , and leaching was not expected. Also, based on its vapor pressure and Henry’s Law Constant, volatilization was not considered important. Fenpropathrin and its major degradate, CONH 2 -fenpropathrin were considered likely to remain in the upper laye rs of the soil, but they could reach surface waters bound to soil particles during rain events accompanie d by erosion. Due to its high level of binding, fenpropathrin would gene rally remain bound to the sediment for prolonged periods of time and would be avai lable by slow dissolution into the water column. Organisms that live near or in the se diments were considered to be particularly
at risk.

Prior to that assessment, in 1999, the EFED i ssued an incremental ri sk assessment for the use of fenpropathrin on apples, pears, citrus fruits, grapes, cucurbits & melons, and head & stem brassica (DP Barcode D257858+). The risk assessment was based on a previous
1996 review. Five issues were stressed in the re view. First, it was st ated that there was a potential for acute and chronic toxicity to freshwater and estuarine/ marine fish and aquatic invertebrates. RQs exceeded the LOCs for all aquatic organisms. Due to its potential to move to surface waters, and its binding tendency to soils/ sediments, fenpropathrin could also pose adverse effects to benthic organisms. Secondly, minimal acute risk to avian species was expected, but there may be chronic risk. Third, similar
conclusions were reached for mammalian species (low acute risk, but with the possibility of chronic risk). Fourth, honeybees, expos ed to fenpropathrin could be adversely impacted from the proposed use of the ch emical. And, finally, endangered birds and

7mammals could show chronic effects and enda ngered freshwater and estuarine/ marine organisms could be also at acute and chronic risk.

In the 1996 review, for the use of fenpropathri n on pears, apples, citrus and grapes (DP Barcode D223864), EFED concluded the fo llowing: "The proposed uses of fenpropathrin should pose very minimal acute risks to avian and mammalian species. However, these uses may present chronic risks to endangered and non-endangered birds and mammals. Also, there is a high potential th at freshwater and estuarine/ marine fish
and invertebrates and benefici al insects may be significan tly adversely impacted from acute and chronic exposures of fenpropathri n applied by ground spray equipment. In addition, endangered species can be jeopardized by acute an d chronic exposure to the chemical. Alterations in aquatic invertebrate populations at any time could affect certain fish life stages, as well as bird s that rely on this food base."

In addition to the registered uses, there are new uses pending registration at the time this problem formulation is written that may also need to be re-evaluated. The uses are as follows: additional tropical and subtropical fr uits (like guava, acerola, feijoa, jaboticaba, passion fruit, starfruit, wax jambu, lychee, longan, Spanish lime, pulasan, rambutan, sugar apple, atemoya, biriba, cherimoy a, custard apple, ilama, soursop).

1999 Scientific Advisory Panel A Scientific Advisory Panel (SAP) in 1999 examined the sediment toxicity and fate of synthetic pyrethroids. In response to a quest ion regarding whether se diment toxicity data on one pyrethroid (cypermethrin) could be us ed to predict sediment toxicity to all pyrethroids, the panel generally supporte d the method of using data from a few pyrethroids to extrapolate information on t oxicity to other pyret hroids. The panel recommended testing cypermethrin, “bifenth rin (relatively non-toxic to freshwater aquatic organisms, very insoluble in water, large bioconcentration factor) and possibly tefluthrin (highly toxic to fr eshwater aquatic organisms, st able in water, intermediate solubility in water to cypermethrin an d fenpropathrin)” (USEPA, 1999). Although this agreement was made in 1999, the new CFR Pa rt 158 requirements include sediment toxicity tests and these studies are considered particularly important for ecological risk assessment of all synthetic pyreth roids, including fenpropathrin.

The SAP commented on the use of K d or K OC to estimate concentrations of synthetic pyrethroids in sediments, recommen ding that the Agency reconsider K OC as a measure of the binding potential of synthe tic pyrethroids to sediment and soil because the use of K d alone limits extrapolation to experimental conditions while K OC “allows one to estimate partitioning across a wide variety of soil/se diment types” (USEPA 1999). The Panel expressed concern that standard methods used to measure sorption may not be applicable to highly hydrophobic compounds due to high solid s to water ratio, consideration of the character of the organic matter, presen ce of dissolved organic carbon, use of nonrepresentative soils and sedi ments as sorbents, and improper methods used to measure organic carbon.

8While the biota-sediment-accum ulation-factor is a widely accepted method of assessment of bioaccumulation in sediments, the Panel indicated that the bioconcentration data for Daphnia and Hyalella should be sufficient to predict bioconcentration of pyrethroids. Finally, the Panel indicated that use of a so lid phase microextraction (SPME) method to
determine the dissolved concentration in wate r could be used to account for sorption of pyrethroids to organic car bon and colloids present in the water column in the
measurement of bioconcentration factors.

In 2003 and in response to the comments from the SAP on pyrethroids, EFED requested the following studies on four synthetic pyret hroids (that did not include fenpropathrin) (memorandum dated 12/22/93, Rexrode & Meléndez 1993): 850.1735: Acute Sediment (freshwater), conducted for 10 days with Hyalella azteca and Chironomus dilutus

, endpoint is survival; EPA/600/R-99/064: Ch ronic Freshwater Sediment Testing conducted for 65 days on Chironomus dilutus (survival, growth ra te and reproduction (# eggs/ female, time to oviposition, proporti on of females ovipositing, % hatch); and EPA/600/R01/020: Chronic Estuarine/ Marine Sediment Testing conducted for 28 days

on Leptocheirus plumulosus (percentage of neonates that su rvive as adults, growth rate, reproduction (#eggs/ female, etc .) and behavior.

2009 Scientific Advisory Panel OPP’s Health Effects Division (HED) pr esented a “Proposed Common Mechanism Grouping for the Pyrethrins and Synthetic Pyrethroids to a FI FRA SAP in June 2009. OPP proposed two subgroups based on Type I or Type II effects related to sodium current tails and neurobehavioral impact, w ith esfenvalerate and fenpropathrin showing symptoms of both types. The panel indicated that substances with mixed characteristics could be included in both groups. 1 This mechanism of action assessment was performed by HED to determine if a cumulative assessment is required for the synthetic pyrethroids; however, the EFED does not conduct cumulative assessments. Fenpropathrin is usually considered a Type II synthetic pyrethroid because it is cyano substituted in the alpha position. Information on the SAP is available in the docket (with non- copyright material available at http:// www.regulations.gov ) under EPA-HQ-OPP-2008-0489.

Open Literature Information There are multiple articles in the open liter ature that indicate concern for fenpropathrin and other synthetic pyrethroids ’ toxicity towards benthic and other non-target aquatic organisms. Also, the articles illustrate fe npropathrin’s prevalence in the environment. Please, refer to Section 3.4 for further details.

Aquatic Life Criteria and Aquatic Life Benchmarks The Clean Water Act requires the Agency to pub lish water quality criteria that accurately
reflect the latest scientific knowledge on the kind and extent of all identifiable effects on health and welfare which might be expected from the presence of pollutants in any body of water, including ground water. While these recommended criteria do not, in themselves, impose any requirements, states and authorized tribes can use them to develop water quality standards. An Aqua tic Life Ambient Water Quality Criteria

1 See Page 18 of the SAP meeting minutes (USEPA 2009).

9document has not been published fo r fenpropathrin (refer to url: http://www.epa.gov/waterscience/criteria/ ).

Based on toxicity values revised by the EPA, the OPP publishes aquatic life benchmarks for freshwater species, based on the most sensitive species from the most recent risk assessments. For fenpropathrin, no aquatic life benchmarks have been published (see url: http://www.epa.gov/oppefed1/ecorisk_ders/a quatic_life_benchmark.htm#benchmarks ).

Impaired Water Bodies Fenpropathrin is not identified as a cause of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Act, based on information provided at http://iaspub.epa.gov/tmdl_waters10/attain s_nation_cy.cause_detail_303d?p_cause_grou p_id=885 . However, the pyrethroids as a group have been identified as a cause for impairment for three water bodies in Cent ral Valley, CA: Del Puerto Creek, Ingram Creek Site (confluence with Hospital Creek to Hwy 33 crossing) and second Ingram Creek Site (confluence with San Joaquin Rive r to confluence with Hospital Creek).

Nonetheless, no Total Maximum Daily Load (T MDL) criteria have been developed for fenpropathrin, based on information provided at the following url: http://iaspub.epa.gov/tmdl_waters10/attain s_nation.tmdl_pollutant _detail?p_pollutant_gr oup_id=885&p_pollutant_group_name=PESTICIDES . More information on impaired
water bodies and TMDLs can be found at http://www.epa.gov/owow/tmdl/ . The Agency invites submission of water quality data for this pesticide. To the extent possible, data should conform to the quality standards in Appendix A of the OPP Standard Operating Procedure: Inclusion of Im paired Water Body and Other Water Quality Data in OPP’s Registration Review Risk A ssessment and Management Process (refer to: http://www.epa.gov/oppfead1/cb/ppdc/2006/november06/session1-sop.pdf ), in order to ensure they can be used quantitatively or qualitatively in pesticide risk assessments.

3. Stressor Source and Distribution

Fenpropathrin ( Table 3.1 ) is a synthetic pyrethroid insect icide and acaricide. Its structure has three rings, two phenyl rings attached to each other by an oxygen atom, and a cyclopropyl ring. It is a Type II synthetic pyrethroid (it is cyano-substituted in the alpha position). The chemistry of fenpropathrin may be dictated by its ester moiety. It would be expected to hydrolyze as the pH increas es; this is confirmed by the hydrolysis study
results. The structure of the molecule ha s one chiral center th at could result in 2 stereoisomers. Chemically, it is the r acemic mixture of both stereoisomers. Fenpropathrin is 2,2,3,3-tetramethyl subs tituted in the cyclopropyl ring.

A summary of physicochemical propertie s of fenpropathrin is included in Table 3.1

.

Table 3.1. Summary of physicoch emical properties of fenpropathrin.

PARAMETER VALUE(S) (units) SOURCE

CAS Chemical Name cyano(3-phenoxyphenyl)methyl 2,2,3,3- tetramethylcyclopropanecarboxylate Fenpropathrin data sheet: http://www.alanwood.net/pe

10Table 3.1. Summary of physicoch emical properties of fenpropathrin.

PARAMETER VALUE(S) (units) SOURCE

IUPAC Chemical Name ( RS )- α -cyano-3-phenoxybenzyl 2,2,3,3- tetramethylcyclopropanecarboxylate sticides/fenpropathrin.html
accessed 01/05/10

PC Code 127901 OPP Databases

Chemical Structure (from chemical’s data sheet)

CAS Reg. No. 64257-84-7 Laskowski, 2002 Molecular Weight 349.4 Laskowski, 2002

Appearance Yellowish brown liquid or solid
with faint characteristic odor Melting Point 25-50oC

Boiling Point 377oC Fenpropathrin Chemical
Fact Sheet Available at http://pmep.cce.cornell.edu/profiles/insectmite/fenitrothionmethylpara/fenpropathrin/insect-proffenpropathrin.html

Solubility ( 25 o C) 1.03x10 -2 ppm or 0.0103 ppm or 10.3 ppb ‘Not Soluble’ according to FAO solubility classification. Laskowski, 2002 FAO, 2000

Vapor Pressure (25 o C) 1.39 x 10 -8 mmHg (by extrapolation)
‘Not volatile under field conditions.’ Laskowski, 2002 USEPA, 2008

Henry’s Law Constant 6.2 x 10 -7 atm-m 3 /mol (from vapor pressure and water solubility) Laskowski, 2002

Octanol-Water Partition
Coefficient (log K OW and K OW ) 6.00 and 1.00 x 10 6 Laskowski, 2002

Octanol-Air Partition
Coefficient

K OA (log K OA ) Constant Law sHenry' RTK

K K K OW

AW OW
OA == = 3.9 x 10 10 (10.6) vs.

3.19 x 10 9 (9.505) Calculated Value vs.
EPISuite v.4.0 Estimate

C water /C air ⎟ ⎠ ⎞ ⎜ ⎝ ⎛

×× ×××

= 6
air water 10GMW P 760RT S

C C = 38,752 (unitless)

‘Slightly volatile from a water surface.’ Calculated USEPA, 2008

OH Radical Reaction
Half-life 0.599 days EPISuite v.4.0 Estimate

Biomagnification
Potential Presumption: If log K OA > 5, log K OW >2
and the rate of chemical transformation is low, the chemical may biomagnify in
terrestrial food chains. ** For fenpropathrin, log K OA > 5, log K OW >2

and rate of transformation appears to be

relatively low in the environment and moderate in fish; it appears that fenpropathrin has a potential to biomagnify
in terrestrial food chains. * *Gobas et al. 2003 and Armitage & Gobas, 2007 support

this presumption utilized here only as
a broad reference to
determine the potential for biomagnification.

Fenpropathrin has a moderately high molecular weight of 349.4 g/mol. It shows a small solubility (0.0103 ppm) and a high oc tanol/ water partition coefficient (K OW = 1.00x10 6 ). Based on it octanol/water partition coeffici ent, it appears that fenpropathrin has the

11potential to bioaccumulate/ bioconcentrate. With a relatively low vapor pressure (1.39 x
10 -8 mmHg), combined with its solubility, it s calculated Henry’s Law Constant is relatively low (6.2 x 10 -7 atm-m 3 /mol). In addition, its C water /C air is 38,752, which classifies it at “slightly volatile from a water surface” (USEPA 2008). The potential to volatilize for fenpropathrin may be attenuated by its tendency to bind to organic matter ( e.g. , soils, sediments or organic matter in the water). For fenpropathrin, the log K OA is 9.5 to 10.6 (EPISuite v.4.0 estimate to calculated), the log K OW is 6.00 and the rate of transformation appears to be low in the envir onment and moderate in fish; it appears that fenpropathrin could have a potential to biomagnify in terrestrial food chains, based on the presumption made by Gobas et al. and Armitage & Gobas in articles published in 2003 and 2007, respectively (refer to Table 3.1 ). Even though EFED has not adopted an official reference or guideline to dist inguish chemicals that biomagnify, Gobas et al. and Armitage & Gobas’ presumption was utilized here as a general or broad reference to detect the potential for biomagnifi cation in terrestrial food chains.

Even though various degradates were observed in the laboratory studies ( e.g. 3-PBA and TMPA), it was found that they were the resu lt of the rupture of the ester bond of the parent molecule. It is believed that the resu lting molecules are not as toxic as the parent because they presumably have lost the neur otoxic mode of action. Furthermore, some other degradates were observed in certain laboratory studies at concentrations exceeding 10% of the applied. Table 3.2 shows the chemical stru ctures of fenpropathrin’s degradation products. At this time, they may be considered stressors.

Table 3.2. Major Transformation Products of Fenpropathrin

Common

Name Chemical Name Structure

m-PBA, mPBAc, 3-PBA
or PBA 3-phenoxybenzoic acid (CAS No. 3739-38-6) O

OH

O

TMPA 2,2,3,3-tetramethylcyclopropane carboxylic acid

OH CH 3 CH 3

CH 3 CH 3 O

Desphenylfenpropathrin ( RS )- α -cyano-3-hydroxybenzyl 2,2,3,3-tetramethylcyclopropane carboxylate (CAS No. 96475-59-1) OH

O CH 3 CH 3

CH 3 CH 3 O

N

12Table 3.2. Major Transformation Products of Fenpropathrin
Common

Name Chemical Name Structure

4’OHfenpropathrin α -cyano-3-(4-hydroxy phenoxy)benzyl 2,2,3,3- tetramethylcyclopropane carboxylate (CAS No. 66280-02-2) O

O

N CH 3 CH 3

CH 3 CH 3 O

OH

COOHfenpropathrin α -carboxy-3-phenoxybenzyl2,2,3,3-tetramethylcyclopropane carboxylate O

O CH 3 CH 3

CH 3 CH 3 O

O OH

CONH 2 - fenpropathrin α -carbamoyl-3-phenoxybenzyl 2,2,3,3-tetramethylcyclopropane carboxylate O

O CH 3 CH 3

CH 3 CH 3 O

O NH

2

3.1. Mechanism of Action

Fenpropathrin is a neural toxic insecticide acting through direct c ontact and ingestion. The pyrethroids (including fenpropathrin) share similar modes of action, and are considered axonic poisons that affect both the peripheral and centr al nervous system. The insecticidal effect of pyrethroids is characterized by a rapid “knock down,” or paralysis, of insects. The primary bi ological effects of fenpropathrin and other pyrethroids on insects and vert ebrates reflect an inhibiti on of the correct firing of neurotransmitter deliver signals from one cell to another via nerve membrane inhibition of the voltage-gated Ca 2+ (calcium ion) channels coupled with a stimulatory effect on the voltage-gated Na + (sodium ion) channels. It is now well established that severe neurological symptoms of poisoning with pyr ethroids in mammals and insects are the
result of modification of the Na + channels activity (cellu lar pores through which Na + ions are permitted to enter the axon to cause excitation) (Matsumura, 1985). Advanced electrophysiological experiments using voltage clamp and patch clamp, together with ligand-binding and ionic flux experiments, have unveiled unique actions of pyrethroids of keeping the Na + channel in the open state for an extremely long period, sometimes as long as several seconds. This modification of Na + channel properties leads to

13hyperactivity of the nervous system. This action leads to spontaneous depolarizations, augmented neurotransmitter secretion rate and neuromuscular block, which ultimately results in paralysis of the insect.

Pyrethroids have also been shown to s uppress GABA and glutamate receptor-channel complexes and voltage-activated Ca 2+ channels, but the toxico logical significance of
these actions is uncertain. Relative to physiological responses, researchers have designated two types of pyrethroids, Type I ( e.g. , bifenthrin, resmethr in, permethrin) and Type II ( e.g. , fenpropathrin, cypermethrin, deltamethr in, fenvalerate). Type I pyrethroids action is mainly associated with compounds that cause nerve excitation symptoms typified by the appearance of repetitive firi ng of axons in the peripheral nervous system and a negatively correlated temperature reversible knockdown property (Clark and Matsumura, 1987). Fenpropathrin is classified as a type II syntheti c pyrethroid, with a cyano group at the α -carbon position of the alcohol moie ty, and is more light-stable and persistent in the environment than early pyrethroids like alleth rin, phenothrin (also commonly known as sumithrin) and resmethri n. Fenpropathrin has one optically active center and is composed of 2 isomers, and like all pyrethroids, is a co ntact poison that can quickly penetrate the nervous system a nd have an effective “knockdown” action (induction of temporary paralysi s) for most flying insects.

3.2. Overview of Pesticide Usage

Fenpropathrin has numerous uses. A summ ary of agricultural use patterns for fenpropathrin, based on the label for DANITOL ® 2.4 EC Spray, is shown in Table 3.3

.

Table 3.3. Summary use information for fenprop athrin agricultural uses, based on label for
DANITOL ® 2.4 EC Spray (Reg. No. 59639-35).

USE SINGLE
APP.
RATE (lbs. a.i./A) NUMBER
OF APPS. SEASONAL
APP. RATE (lbs. a.i./A) INTERVAL
BETWEEN APPS. (days) APP.
METHOD PREHARVEST
INTERVAL (days)

Head and stem brassica (broccoli, brussel sprouts, cabbage, cauliflower, cavalo broccolo, Chinese bro ccoli-gal lon, Chinese cabbage-napa, Chinese mustard cabbage-gal choy, Kohlrabi, Brussels sprouts, cauliflower) 0.2-0.3 3-4 0.8 7 G, A 7

Citrus 0.2-0.4 2-4 0.8 10 G, Airblast, A 1

Cotton 0.15-0.3 3-5 0.8 7 G, A 21

Cucurbits (balsam apple, balsam pear, bitter melon, chayote, Chinese cucumber, Chinese waxgourd, citron melon, cucumber, edible gourd, gherkin, honeydew, Momordica spp. , muskmelon, pumpkin, summer squash, watermelon, winter squash) 0.2-0.3 3-4 0.8 7 G, A 7

14Table 3.3. Summary use information for fenprop athrin agricultural uses, based on label for
DANITOL ® 2.4 EC Spray (Reg. No. 59639-35).

SINGLE PRESEASONAL INTERVAL

USE APP. HARVEST
RATE NUMBER (lbs. a.i./A) OF APPS. APP. RATE (lbs. a.i./A) BETWEEN APP. INTERVAL APPS. (days) METHOD (days)

Fruiting vegetables (bell pepper, chili pepper, cooking pepper, eggplant, ground cherry- Physalis spp. , pepino, pimento, sweet pepper, tomatillo, tomato) 0.15-0.2 4-5 0.8 7 G, A 3

Grape 0.1-0.4 2-8 0.8 7 G, A 21

Peanut 0.1-0.3 3-8 0.8 7 G, A 14

Pome fruit (apple, crabapple, loquat, mayhaw, quince, oriental pear, pear) 0.2-0.4 2-4 0.8 10 Airblast 14

Strawberry 0.2-0.4 2-4 0.8 30 G 2

Pea (English pea, garden pea, green pea, pigeon pea) 0.2 4 0.8 7 G, A 7

Currant 0.2-0.3 3 0.8 7 G 21

Bushberries (blueberry-highbush and lowbush, elderberry, gooseberry, huckleberry, juneberry, lingonberry, rabbiteye, salal) 0.2-0.3 2 0.6 14 G, A 3

Caneberries (blackberry-including bingleberry, boysenberry, dewberry, lowberry, marionberry, olallieberry and youngberry; loganberry; black raspberry; red raspberry) 0.2-0.3 2 0.6 14 G, A 3

Olive 0.2-0.3 3-4 0.8 14 G 7

Stone fruits (such as apricot, cherry, nectarine, peach, plum and prune) 0.2-0.4 2-4 0.8 10 Airblast 14

Tree nut (such as almond, beechnut, cashew, chestnut, chinquapin, filbert (hazelnut), hickory, macadamia, pecan, pistachio, walnut) 0.2-0.4 2-4 0.8 10 Airblast 14

Barley 0.2 1 0.2 N/A G 14

Tropical and subtropical fruits (inedible peel, including but not limited to avocado, canistel, mango, papaya, sapodilla, black and mamey sapote, star apple) 0.3-0.4 2 0.8 14 G 1

In addition to the uses listed in the table, new uses pending registration at the time this problem formulation is written may also need to
be re-evaluated. The uses are as follows: additional tropical and subtropical fruits (guava, acerola, feijoa, jaboticab a, passion fruit, starfruit, wax jambu, lychee, longan, Spanish lime, pulasan, rambutan, suga r apple, atemoya, biriba, cherimoya, custard apple, ilama, sour sop) , the application parameters are the same than for the tropical fruits listed in the row above.

DANITOL ® 2.4EC is an emulsifiable concentrate. The chemical may be applied by

15ground or aerial methods. The uses are for tr eatment of crops at the rate of 0.1-0.4 lb a.i./A/application to be applied at a maximum of 8 times per year at 7-14 day intervals
with a maximum of 0.2-0.8 lb ai/A/season. The labels for fenpropathrin require a buffer zone of 10 ft within certain bodies of water, such as lakes, reservoirs, rivers, permanent streams, marshes or natural ponds, estuaries a nd commercial fish farm ponds, so as to allow growth of a maintained vegetative filter strip. The agricultura l products should not be applied by ground equipment within 25 ft, by aerial equipment within 150 ft, or by
ULV within 450 ft of freshwater or estuarine/ marine bodies of water.

The usage of fenpropathrin, from the Scr eening Level Usage Analysis (SLUA) is provided in Table 3.4 . The table is arranged in alphabetic al order of crops. According to the table, the major agricultural uses for fe npropathrin are apples, grapes and oranges, followed by strawberries, tomatoes and cotton, in that order. For apples and strawberries, the average percent crop treated are the hi ghest, with 10 and 25%, respectively, while for other crops, the average percent crop treated is ≤ 5%. The highest maximum percent crop treated is for strawberries (50%), followed by oranges (30%), and gr apes and pears (with 20%).

Table 3.4. Screening-Level Estimates of Agri cultural Uses of Fenpropathrin (SLUA, dated 08/07/09).

Percent Crop Treated

Crop lb a.i. Avg. Max.

Apples 20,000 10 15

Asparagus + <500 <1 <2.5

Broccoli <500 <1 <2.5
Cabbage <500 <1 <2.5
Cantaloupes <500 <2.5 10

Cauliflower <500 <1 <2.5

Cherries <500 <1 <2.5

Cotton 4,000 <1 <2.5

Cucumbers <500 <1 <2.5

Grapefruit 2,000 5 20

Grapes 20,000 5 10

Lemons <500 <1 <2.5

Oranges 20,000 5 30

Peanuts 1,000 <1 <2.5

Pears 2,000 5 20

Peppers 2,000 5 10
Pumpkins <500 <1 <2.5

Squash <500 <1 <2.5

Strawberries 7,000 25 50

Tomatoes 3,000 5 10

Watermelons <500 <1 <2.5

16Table 3.4. Screening-Level Estimates of Agri cultural Uses of Fenpropathrin (SLUA, dated 08/07/09).

All numbers are rounded. '<500' indicates less than 500 pounds of active ingredient. '<2.5' indicates less than 2.5 percent of crop is treated. '<1' indicates less than 1 percent of crop is treated. ‘+’ Cr ops not known to be listed on active end use product registrations or as Section 18 emergency exemptions when the report was run. The
sources of the SLUA include the USDA-NASS , Private Pesticide Market Research, the National Pesticide Use Database (NPUD 2002) of the CropLife Am erica Foundation and California Department of Pesticide Regulatio n (CDPR) data. The information reflects amalgamated data developed by the Agen cy and are in a releasable format.

The U.S. Geological Survey (USGS) pesticide use maps ( Fig. 3.1 ) show regional scale patterns in use intensity within the United St ates. The USGS pesticide maps are based on State level estimates of pesticide use ra tes for individual crops, which have been compiled by the National Center for Food and Agricultural Policy (NCFAP) for 1999 through 2004, and on the 2002 Census of Agriculture for county crop acreage crop.

According to the USGS map, the crops of highest use for fenpropathrin were apples, grapes and cotton in 2002 (12,961-18,572 lb ap plied nationwide). These crops were followed in importance by citrus fruits, stra wberries, peanuts, tomatoes, and pears (2,104- 6,711 lb applied nationwide). It is noted that there are potential estu arine/ marine areas
of concern in the East and West coast as well as the Gulf. As expected, there is a general agreement between the SLUA and the USGS ma p. The map shows a generalized use of fenpropathrin for agricultural purposes througho ut the country, with highest uses in the east and west coasts, and the Midwest. The map also shows the potential for use in areas near estuarine/ marine environments. Multiple agricultural uses are approved for the chemical, other than the ones in th e map, as indicated above in the Table 3.2

.

17Fig. 3.1. Estimated Use of Fenpropathrin in 2002

Note of Caution: The pesticide use maps available ( http://water.usgs.gov/nawqa/pnsp/usage/maps/compound_listing.php?year=02 ) show the average annual pesticide use intensity expressed as av erage weight (in pounds) of a pesticide applied to each square mile of ag ricultural land in a county. The area of each map is based on state-level estimates of pesticide use rate s for individual crops that were compiled by the CropLife Foundation, Crop Protection Research Institute during based on information collected during 1999 through 2004 and on 2002 Censu s of Agriculture county crop acreage. The maps do not represent a specific year, but rather show typical use patterns over the five year period 1999 through 2004. Use intensity rates are expressed as the pounds applied per square mile of mapped agricultural land in a county. The area of mapped agricultural land for each county was obtained from an enhanced version of the 1992 USGS National Land Cover Data (NLCD) . The key limitations of the data used to produce these maps include the following: (1) state use coefficients represent an average f or the entire state and consequently do not reflect the local variability of pesticide management practices found within states and counties, (2) p esticide use estimates are not for a specific year, but represent typical use patterns for the five year period, (3) state pesticide use coe fficients may not have been available for all states where a pesticide may have been applied to agricultural land, and therefore, are not displayed on the maps, (4) the county crop acreage is based on th e 2002 Census of Agri culture and may not represent all cr op acreage because of Census nondisc losure rules, and (5) agricultural land area used to calculate the pesticide use intensity and display the data was derived from 30-meter sat ellite remote sensing data that may over estimate or underestimate the actual agricultural land area. The maps are not intended for making lo cal-scale estimates of pesticide use, such as estimates at the county level. Please refer to Method for Estimating Pesticide Use for a detailed discussion of how the pesticide use data were developed.

In addition to the classical agricultural use sites, fenpropathrin has various other uses. These uses include food/feed use sites, non-food/ non-feed use sites and greenhouses. Examples of these uses include agricultura l uncultivated areas, deciduous fruit trees, forest trees, ornamental and/ or shade tree s, ornamental herbaceous plants, ornamental non-flowering plants, and ornament al woody shrubs and vines. Table 3.5 provides a summary of the terrestrial nonagricultural us es for fenpropathrin. Application methods vary. Many of these uses could involve subs tantive exposure to wildlife, specifically, aquatic organisms, and they will be assesse d accordingly. The greenhouse uses are not
assessed.

18Table 3.5. Nonagricultural Uses for Fenpropathrin

Use Max. App. Rate/ units Max. No. Apps./
Year Max. App. Rate per

Year Min. App. Int./ days agricultural uncultivated areas 0.4 lb a.i./A NS 0.8 lb a.i./A NS deciduous fruit trees (unspeci fied) 0.3 lb a.i./A; 0.0069 lb 1K sq.ft NS NS 7 forest trees (softwoods, conife rs) 0.3 lb a.i./A NS NS 7
ornamental and/or shade trees 0.3 lb a.i./A; 0.0055 lb 1K sq.ft NS NS NS or 2 ornamental herbaceous plants 0.3 lb a.i./A; 0.0055 lb 1K sq.ft NS NS NS or 2 or 7 ornamental nonflowering plants 0.3 lb a.i./A; 0.0055 lb 1K sq.ft NS NS NS or 2 or 7 ornamental woody shrubs and vines 0.3 lb a.i. /A; 0.0055 lb 1K sq.ft NS NS NS or 2 or 7 NS = Not Specified; AN = As Needed . Data obtained from LUIS Report.

According to the agricultural label for fenpropathrin ( i.e. for DANITOL ® 2.4 EC Insecticide/ Miticide, EPA Reg. No. 59639-35), the product mixes readily with water and
can be tank mixed with Orthene ® 90 S (a product which cont ains the active ingredient acephate, an insecticide for use on cott on only, Reg. No. 5481-8974). There are two coformulated products of fenpropathrin with other active ingredients. One product is coformulated with acephate (Reg. No. 499-441), and it is for indoor uses only on ornamental plants in commercial greenhouses. The spray drift associated with this indoor use will be minimal. The other product (named V-10141 2.8EC) is coformulated with etoxazole (Reg. No. 59639-137), for certain out door uses (apples, cotton, pears and strawberries).

Toxicity data on environmental mixtures of fenpropathrin with other pesticides may be presented, if available, as part of the ecological risk assessment. It is expected that the toxic effect of fenpropathrin, in combinat ion with other pesticides used in the environment, is likely to be a function of many factors including but not necessarily limited to: (1) the exposed species , (2) the co-contaminants in the mixture, (3) the ratio of fenpropathrin and co-contaminant concentra tions, (4) differences in the pattern and duration of exposure among contaminants, a nd (5) the differential effects of other physical/chemical characteristic s of the receiving waters ( e.g. organic matter present in sediment and suspended water). Quantitative ly predicting the combined effects of all
these variables on mixture t oxicity to any given taxa with confidence is beyond the capabilities of the available data and methodologies. Howeve r, a qualitative discussion of implications of the available pesticide mixture effects data rega rding the confidence of
risk assessment conclusions will be addresse d as part of the uncertainty analysis.

Piperonyl butoxide (PBO) and MGK-264 are commonly used in formulations with certain pyrethroids. PBO acts as a potentia tor in both mammals a nd insects because the pyrethroid is not metabolized and excreted as quickly in its presence (Barile 2004; Hodgson & Smart 2001). Exposure to pyrethr oids along with piperonyl butoxicide increases the toxicity of the pyrethroids (Amweg & Weston 2007; Weston & Lydy 2010). MGK-264, another potentiator/s ynergist used with pyrethroi ds, has similar effects as those observed for piperonyl butoxide (Hodgson & Smart 2001).

The Agency routinely assesse s potential exposure to form ulations by examining acute exposure due to spray drift. Acute toxicity data on the formulation is compared to potential exposure to spray dr ift. There are no fenpropathri n registration products that

19contain PBO or MGK-264. However, pipero nyl butoxide and/or MGK-264 from other pyrethroid applications ( e.g. the application of an adul ticide containi ng PBO), could interact with fenpropathrin in the environment. Therefore, potential interactions will be discussed qualitatively in the risk assessment.

3.3. Environmental Fate and Transport

A summary of environmental fate/ transport properties of fenpropathrin is included in
Table 3.6

.

Table 3.6. Summary of environmental fate/ transport properties of fenpropathrin.

PARAMETER VALUE(S) (units) SOURCE (MRID) COMMENT
Hydrolysis Half-life [pH 5, 7, 9; (25 o C)] Relatively stable at pHs 6-8 & 25oC;

vs. pH 5 and pH 7 stable

pH 9 14.3-17.1 days 131438, 141320,
42599901 * Half-lives reported by Laskowski 2002: relatively stable at pH 5 and 7, and 13.8 days at pH 9.

Aqueous Photolysis
Half-life Stable (buffer contained 8% acetonitrile). Samples exposed to sunlight in CA. 43917227 Limited supplemental data (MRID 137769): 16.2 weeks (~113 days) in distilled water containing an emulsifier (PBA, TMPA and decarboxy-fenpropathrin were major). 2-7 weeks in natural river and sea waters fortified with 1 ppm humic acid. 1.6 days in 2% acetone

solution. * Half lives reported by
Laskowski 2002: in unbuffered solution, in the presence of an emulsifier 14.6 and 87.5 days.

Soil Photolysis Halflife Relatively stable in SL ( ≤ 10% degradation in 30 days; samples
were irradiated with natural sunlight in CA) 137769, 42546402 In a supplemental study, 3.8-10.3 days in irradiated samples vs. 36.6- 155 days in dark controls (light clay, SL & SCL). CONH 2 -fenpropathrin
observed in both irradiated and dark

control samples. Samples were irradiated with natural sunlight.

* Half-lives reported by Laskowski 2002: 3.77, 9.16, 9.42 days in air dry soil correspond, presumably, to the same study listed above.

20Table 3.6. Summary of environmental fate/ transport properties of fenpropathrin.

PARAMETER VALUE(S) (units) SOURCE (MRID) COMMENT

Aerobic Soil
Metabolism Half-life 152 days (SiL) 42525902 33-35 days (light clay), 34-39 days (SCL) from MRIDs 126823, 130869, 142547, provide limited supplemental data.
Sakata et al. 1990 11 and 17 days for SCL and light clay from Japan. Half-lives reported by Li et al. 2009:
15.3-16.2 in alkaline loam and 31.1 in acidic loam (soils from China).
See notes below in Section 3.4 ).

* Half-lives reported by Laskowski 2002: 34.1, 32.1, 34.8, 36.5, 39.4, 133, 34.7, 51.3, 221, 186 days for SCL, C, SCL, C, SL, C, SL, SC, SC, L, respectively.

Anaerobic Soil
Metabolism Half-life 186 days (L)
Soil was incubated in aerobic condition for 30 days and made
anaerobic for 2 months. 42546403 Akhtar et al. 2004 relatively persistent in a Pakistan soil.

* Half-lives reported by Laskowski 2002: 283 & 383 days for C & SCL, respectively.

Aerobic Aquatic
Metabolism Half-life Not available N/A Half-lives reported by Gan et al. 2008: 89 and 152, from two sediments (see notes below in
Section 3.4 )

Anaerobic Aquatic
Metabolism Half-life 78 and 67 days in CA loam; formation of PBA and TMPA (data screened and currently in review). 44370003,
44370004 * Half-lives reported by Laskowski 2002: 93.4, 85, 57.8 days for L, L, SL, respectively.

Adsorption/ Desorption - Batch Equilibrium
Soil Partition
Coefficient (K d & K OC ) Soil Type K d K OC sandy loam 267 33746
silt loam 810 85263 clay loam 266 23340
loam 64 13870 aq. sediment 779 34453 Measurements made at a single

concentration; test solutions
contained 0.2% v/v acetonitrile. Screened data from an update/ upgrade of the study (currently in

review), shows the following Freundlich adsorption coefficients:

Soil Type K F K FOC sandy loam 184 23300
silt loam 486 51100 clay loam 252 22100
loam 212 46200 aq. sediment 662 29300 42584101,
44370002 5x10 5 – mean of two sediments (reported by Gan et al. 2008,
refer to Section 3.4 ).

Terrestrial Field Dissipation 144 days WA (apples) 8 days NY (apples) 14 days CA (grapes) 95 days MS (cotton)

17 days CA (bare) 41679601, 41525905, 41525904, 42311401,
42311402 –

21Table 3.6. Summary of environmental fate/ transport properties of fenpropathrin.

PARAMETER VALUE(S) (units) SOURCE (MRID) COMMENT

Bioaccumulation in Fish (BCF) 200x, 830x, 1400x for fillet, whole fish and viscera, respectively. 65 and 5% depurated after 3 days, for viscera and fillet respectively. By day 21, 78-84% of the residues

had been eliminated from fillet. 00153802, 00161672, 00161673,
00163521 Residues were characterized as 42- 81% parent; also present were 3-

PBA, 3-(4-hydroxyphenoxy) benzoic acid, TMPA, α -cyano-3-phenoxybenzyl 2-hydroxymethyl2,3,3-trimethylcyclopropane carboxylate, 2-carboxy-2,3,3- trimethylcyclo propanecarboxylic

acid & 2-hydroxymethyl-2,3,3- trimethylcyclopropanecarboxylic acid. [Study 161773 screened only.]

Studies conducted on fenpropathrin indicate that it is mostly persistent under laboratory conditions but degrades with va rying rates under field conditions . Fenpropathrin is stable to hydrolysis at lower pHs but undergoes degrada tion in alkaline media. It appears to be stable to aqueous and soil photolysis condi tions and degrades sl owly under both aerobic
and anaerobic soil metabolism conditions. Fi eld studies show vary ing degradation rates and relatively low mobility of the chemical in soil. Fenpropathrin shows very low mobility in soils. Based on the available data, the major routes of dissipation for fenpropathrin are likely microbial degradati on and soil binding. Ne w laboratory studies requested in this document, in particular , the photolysis and aerobic soil metabolism studies, will shed more light on the possibl e routes of dissipation for the chemical.

Fenpropathrin can be spray applied by ground or aerially on agricultural settings. A buffer region is label recommended ( e.g. 150 ft. for aerial applic ations that do not use ULV); however, under a high end drift scenario ( e.g. small droplets and/ or high wind speed), substantial amounts of the chemical can reach adjacent bodies of water via spray
drift. Substantial fractions of the chemical may be available in the soils once it is applied
for the first few weeks to several months after application. Due to it s low solubility (10.3 ppb) and high level of binding (K OC values were 13900 to 85300) it appears that fenpropathrin would remain bound to the soils during run-off events and it may reach surface waters if the run-off event is accompanied by erosion. Once fenpropathrin reaches surface waters, the fate of the chemical is of concern since fenpropathrin is very toxic to fish. EFED believes that fenpropa thrin, due to its high level of binding, would generally remain bound to the sediment fo r prolonged periods of time and will be available by slow dissolution into the water column. Organism s that live near or in the sediments may be particularly at risk.

Fenpropathrin has low mobility, and is not like ly to reach subsurface soil environments (with lower microbial activity) or ground waters . Five terrestrial fi eld dissipation studies confirm that fenpropathrin and its degradate CONH 2 -fenpropathrin remain in the upper
soil level.

Degradation and Metabolism Fenpropathrin was stable to hydrolysis in pH 5 and 7 aqueous solutions, but degraded at pH 9 with half-lives of 14.3-17.1 days. Four degradates were pr esent in the pH 9

22solution: TMPA comprised 39.4-42.8% of the applied at 21-30 days; CONH 2

– fenpropathrin was ≤ 8.9% of the applied at all test in tervals; TMPA-carboxamide was 8.8- 13.3% of the applied at 15-30 days; and PB A reached a maximum of 61.2-63.5% of the applied at 30 days.

Fenpropathrin did not degrade under aqueous photolysis conditions and was relatively stable under soil photolysis condition. No major metabolites were identified in the aqueous photolysis study. The metabolite iden tified in the photolysis on soil study in the
irradiated and dark control was CONH 2 –fenpropathrin at 5.9 and 10.9%, respectively.

Fenpropathrin degraded slowly under both aerobic and anaerobic soil metabolism conditions, with calculated half-lives of 152 and 186 days, respectively. In the aerobic soil metabolism study the major degradate was carbon dioxide, which was 59.9% of the applied after one year. Several minor metabolit es were identified (refer to table below). In the anaerobic soil metabolism study, th e major metabolites were PBA and COOH– fenpropathrin (both at ≤ 11.5% of the applied).

Based on the submitted data, most of the laboratory studies indicate that fenpropathrin is highly persistent. In the case of hydrolysis , only under alkaline conditions, two major degradates – TMPA, and PBA – were formed at a maximum of 42.6% and 63.5% of the applied, respectively, in a period of 30 days. These degradates were not only persistent, but appear to be highly mobile in the soil due to the presence of a car boxylic acid moiety. However, both these degradates were not m onitored in any of the terrestrial field dissipation studies.

Although the degradation of fe npropathrin could follow a num ber of parallel degradation pathways, it appears more likely that th e major route of dissipation is microbial dissipation in soil. Aerobic and anaerobi c soil metabolism studies indicate that fenpropathrin is resistant to microbial degr adation; however, a cl oser look at the two
studies reveals that the dose rate in both st udies exceeded the solubility of the chemical (10.3 ppb, see Laskowsky 2002); there is a stro ng possibility that this could have precipitated the chemical on the soil which w ould have erroneously led to the conclusion
that the chemical was stable. The same a ppears to be true for the photodegradation on soil study. Additional aerobic soil metabolis m and anaerobic soil metabolism studies would provide more reliable data that c ould help in defining the major route of dissipation of fenpropathrin in the field. EFED believes that these studies will shed more light on the significance of thes e degradation processes and mo re clearly define the major route of dissipation of fenpr opathrin in the environment.

Transport and Mobility Supplemental data from an Adsorption/ De sorption (batch equilib rium) study indicate that fenpropathrin was adsorbed strongly to soils and was hardly mobile in silt loam sediment, sandy loam, silt loam, and clay loam soils (FAO mobility classification). The adsorption K d values were 64-810, and the K OC values were 13870-85260 (measured at the highest concentration only, which consti tutes an uncertainty). The registrant submitted additional data to upgrade this study (MRID# 44370002). These results have

23not been fully reviewed, but they were sc reened and found to be reviewable. The additional data supports the conclusion that fenpropathrin is strongl y adsorbed to soils and is not expected to leach substa ntially. Results are as follows:

Table 3.7. Freundlich Adsorption and Desorption Constants for Fenpropathrin Soil Type %OC K F (adsorption) K FOC (adsorption) K F (desorption) K FOC (desorption) sandy loam 0.79 184 23300 314 39700

silt loam 0.95 486 51100 283 29800 clay loam 1.14 252 22100 278 24400

loam 0.46 212 46200 381 82800 aquatic sediment 2.26 662 29300 912 40400

Fenpropathrin is relatively insoluble in water (reported solubility 10 ppb) and nonvolatile (vapor pressure 1.39x10 -8 mmHg). It Henry’s Law C onstant is relatively low (6.2 x 10 -7 atm-m 3 /mol). The chemical is unlikely to volatilize substantia lly. The rate of
volatilization is further attenuate d by the high adsorption that the chemical shows to soils, sediment and organic matter.

Bioaccumulation in Fish Fenpropathrin residues accumulated in bluegill sunfish, with bioconcentration factors of 200x, 830x, and 1400x in fillet, whole fish and viscera, respectively. Accumulated residues depurated rapidly from the viscera, but relatively slowly from the fillet (65 and 5% depurated after 3 days, respectively).

In the tissue, [ 14 C]-residues were 42-81% fenpropathrin, 3.6-6.5% α -cyano-3- phenoxybenzyl-2-hydroxymethyl-2,3,3-trim ethylcyclo-propanecarboxylate, 0.9-13.4% PBA, 0.8-7.8% 3-(4-hydroxyphenoxy)be nzoic acid, 2.9-15.4% TMPA, 2.2-12.6% 2- carboxy-2,3,3-trimethylcyclopropanecarboxylic acid, and 0.3-2.5% 2-hydroxymethyl2,3,3-trimethylcyclopropanecarboxylic acid.

Field Dissipation Results from five terrestrial field dissipat ion studies conducted in Washington, California, New York and Mississippi showed that fenpropa thrin remains in the upper layers of soil (upper 7.5 or 15 cm). However, reported half-lives showed a wide range from 8 to 144 days. The registrant has provide d no valid reason for the diffe rences in the persistence of fenpropathrin under laboratory and field conditio ns or between similar terrestrial field dissipation studies. Detailed comparison of two apple orchard studies conducted in Washington and New York did not provide conclusive evidence for the differences in reported half-lives. The different half-lives for the field dissipati on studies might be due
to different environmental c onditions that affect dissipati on or degradation mechanisms such as soil photolysis or aerobic soil metabolism.

Although the major route of dissipation of fenpropathrin in the field remained unidentified, terrestria l field dissipation studies indicat e that fenpropathrin dissipates at moderate rates in the field; fairly quickly in some instances (half-lives 8, 14 and 17 days, for studies conducted on cropped apple orchar d, grapes and bareground, respectively) and more slowly in other inst ances (95 and 144 days in tw o other studies, on cotton and

24apples, respectively). The observed differences in the rate of dissipation of fenpropathrin
in the field could be due to a number of vari ables such as geographi cal location, climatic conditions, and microbial population of the soil at different test si tes; these variables affect the dissipation processes (such as photolysis, microbial degradation, and irreversible binding to the soil ) some or all of which could be involved in the dissipation
of the chemical in the field.

The data from the field studies clearly i ndicate that fenpropath rin and its degradate
CONH 2 -fenpropathrin are likely to remain in the upper layers of the soil and show no potential to leach in ground waters due to their high adsorption and low mobility in soil. However, residues of fenpropathrin and its major degradate may reach surface waters bound to soil particles during rain events accompanied by erosion.

Degradate Formation
Table 3.8 is a summary of degradate formation fo r fenpropathrin. Note that, despite the fact that fenpropathrin is pers istent under various conditions, or dissipates very slowly in all studies, various transformation products comprised ≥ 10% of the applied.

Table 3.8. Summary of degradate formatio n from degradation of fenpropathrin.

DEGRADATE and MAXIMUM CONCENTRATION STUDY TYPE SOURCE

DEG1 (% applied) DEG2 (% applied) DEG3 (% applied)

Hydrolysis 131438, 141320,
42599901 At pH 9, PBA at a maximum of 63.5% at 30 days; CONH 2 - fenpropathrin, was ≤ 12.6% of the applied at all test intervals.
TMPA-carboxamide increased to 8.8-13.3% of the applied at 15-30 days.

Aqueous Photolysis 43917227 NO aqueous photolysis product exceeded 10% of the applied during the study. Unidentified [ 14 C] compounds totaled ≤ 4.4% of the applied in all solutions at all sampling intervals.

Soil Photolysis 137769, 42546402 CONH 2 -fenpropathrin was a maximum of 5.6 and 10.9% of the applied.

Aerobic Soil
Metabolism 126823, 130869, 142547, 42525902 PBA (maximum 1.25% of the applied), CONH 2 -fenpropathrin(0.21%), desphenylfenpropathrin (0.55%), and 4'-OHfenpropathrin (0.039%).

Anaerobic Soil
Metabolism 42546403 PB-acid to 11.5% by day 60 postflooding; COOH-fenpropathrinincreased to 6.36% at 60 days postflooding; 4'-OHfenpropathrin comprised ≤ 0.35% through the study; and,
CONH 2 -fenpropathrin was ≤ 0.67% during the anaerobic phase.

Aerobic Aquatic
Metabolism N/A Not available

Anaerobic Aquatic
Metabolism 44370003, 44370004 (screened and in review) Based on screened data, TMPA and PBA are the major degradates.

25Table 3.8. Summary of degradate formatio n from degradation of fenpropathrin.

DEGRADATE and MAXIMUM CONCENTRATION STUDY TYPE SOURCE

DEG1 (% applied) DEG2 (% applied) DEG3 (% applied)

Terrestrial Field Dissipation 41679601, 41525905, 41525904, 42311401,
42311402 4’-OH-fenpropathrin, CONH 2 -fenpropathrin and desphenylfenpropathrin detected in certain studies.

Degradation products observed in the laborat ory studies or in th e field included 4’-OHfenpropathrin, CONH 2 -fenpropathrin and desphenyl-fenpr opathrin (which preserve the basic structure profile of the parent mol ecule (the ester bond), and PBA and TMPA, which are the product of r upture of the ester bond.

Uncertainties The major uncertainties with respect to th e environmental fate studies on fenpropathrin are related to the extremely low solubility of fenpropathrin and th e problems found when the registrant performed these studies. Th e aqueous photolysis study was performed in unusually high concentrations of acetonitrile. However, no substantial photolysis was observed. The cosolvent may have had an eff ect on the results. Furthermore, the batch equilibrium studies were performed at a sing le concentration (a Freundlich isotherm was not developed). EFED has had to rely on sing le point results. An additional source of uncertainty is the absence of aerobic and an aerobic (only one soil available) aquatic metabolism studies. The persis tence of fenpropathrin in aquatic environments is
uncertain.

Another source of uncertainty for this chemi cal is the difference observed in laboratory studies, compared to the field. Results from five terrestr ial field dissipation studies showed that fenpropathrin remains in the uppe r layers of soil, but reported half-lives showed a wide range from 8 to 144 days. Th e registrant has provi ded no valid reason for the differences in the persistence of fenpr opathrin under laboratory and field conditions or between similar terrestrial field dissipati on studies. The observed differences in the rate of dissipation of fenpropathrin in the fiel d could be due to a num ber of variables such as geographical location, c limatic conditions, and microbi al population of the soil at different test sites; these va riables affect the dissipation processes (such as photolysis, microbial degradation, and irreve rsible binding to th e soil) some or all of which could be involved in the dissipation of the chemical in the field. Although the degradation of fenpropathrin could follow a number of paralle l degradation pathways, it appears more likely that the major route of dissipation is microbial dissipation in soil. However, the
aerobic and anaerobic soil metabo lism studies indicate that fe npropathrin is resistant to microbial degradation. EFED believes that the metabolism studies required in this document will shed more light on the significance of these degradation processes and more clearly define the major routes of dissi pation of fenpropathrin in the environment.

263.4. Open Literature Information

The following is a cursory search of the available literature on fenpropathrin and synthetic pyrethroids in gene ral, mostly about their prev alence/occurrence, and about their toxicity to aquatic invertebrates and sediment dwelling organisms (which also pertains to Section 4.1 ). It is not intended to be exhaustive. In th e relatively recent past
there has been an increased awareness of th e prevalence and toxic ity of fenpropathrin, and other synthetic pyrethroids, in sediment environments of urban and agricultural sites, particularly in California.

Two major factors affect the to xicity of the synthetic pyreth roids: the presence of the synergist piperonyl butoxi de (PBO) and the temperature. Amweg and Weston, 2007, documented the effects of the presence of PB O in sediments containing the representative synthetic pyrethroid, bifenthrin and other chemicals [cadmium (a metal), chlorpyrifos (an organophosphate), DDT (an organochlorine), and flouranthene (a polycyclic aromatic hydrocarbon)]. The 10-day Hyalella azteca LC50 was 0.26 μg/g OC vs. 0.12 μg/g OC in the presence of PBO in the overlying water at 25 μg/L (increased toxicity by a factor of 2.2). For the other chemicals, the factor was ar ound or less than 1 (implicating no synergism) with no statistical difference in toxicity for all but chlorpyrifos. Eight field collected sediments, containing a variet y of synthetic pyrethroids, or synthetic pyrethroids and chlorpyrifos (except for one sediment that contained only chlorpyrifos), that were previously tested and found to be toxic to Hyalella azteca , were examined with and without the presence of PBO. All the sediments exhibited higher toxicity in the presence of PBO except for the sediment th at contained only chlorpyrifos.

The effect of temperature was documented by Weston et al. , 2009a. In an effort to identify factors affecting the toxicity iden tification evaluation (TIE) of the synthetic pyrethroids ( i.e. “manipulating a sample in a manner that alters the toxicity of some toxicants but not others”), they performed sediment toxicity tests at various temperatures (13, 18, 23, or 28oC). 10-day LC50’s to Hyalella azteca were determined for four pyrethroids (not including fe npropathrin), also for chlorpyrifos, cadmium and DDT (which were representative of other classes of pesticides). For the four pyrethroids, the toxicity approximately doubled when the te mperature was decreased from 23 to 18oC, and approximately tripled when the temperat ure was further decreased to 13oC. The results at 28oC were mixed, but for some of the control samples, survival was low, which could indicate that the test species was not to lerant of the changes to high temperature. DDT presented a similar response profile with temperature, but not as pronounced as for the synthetic pyrethroids. For chlorpyrifos and cadmium, the responses with temperature were nearly independent of temperature, a nd opposite to the one for the pyrethroids, respectively. Various field samples with known amounts of pyrethroids also showed similar responses to those of the tested pyr ethroids (as indicated above), with a few exceptions. The authors discussed the po ssible repercussions of the temperature dependence of the synthetic py rethroids during the winter se ason, when the temperatures
of the waters and sediments are lower. Even though these studies did not include fenpropathrin, they illustrate the effects of the presence of PBO and temperature on certain synthetic pyrethroids and, by extrapol ation, may apply to fenpropathrin as well.

27In a recent study (Stout II, et al. 2009), conducted by the US Department of Housing and Urban Development, in collaboration with th e Agency, several chemicals were surveyed on floors of occupied homes. The survey included fenpropathrin and several other synthetic pyrethroids. Fenpropathrin was de tected with a frequency of 4% (mean and
standard deviation not calcul ated, maximum value = 1.1 ng/cm 2 ), illustrating that this chemical is detected and present in homes. The synthetic pyrethroids more frequently
detected were cis- and trans- permethrin (88-89% frequenc y). Fenpropathrin is not among the constituents monitored by the National Water Quality Assessment (NAWQA), maintained by the U.S. Geological Survey.

Holmes et al. 2008 presented the occurrence and toxi city of the synthetic pyrethroids throughout the state of Californi a’s urban creek sediment sa mples. First, 90 samples were screened for toxicity to Hyalella azteca , of which around one third caused significant toxicity to the organisms. Later, 30 sample locations were selected for the final study. Of the 30 samples, 25 were toxic to Hyalella azteca at 23oC and all 30 samples were toxic at 15oC (the synthetic py rethroids often show hi gher toxicity at lower temperatures, see above). Seven of eight py rethroids were detected in the sediment samples. Fenpropathrin was not detected in any of the samples, but bifenthrin was present in all the 30 samples (2.19 to 219 ng/g dry weight). Permethrin was the second most detected pyrethroid. The results s uggest an important role of the synthetic pyrethroids in California’s ur ban creeks sediment toxicit y. Bifenthrin accounted for around two thirds of the toxicity on an average basis. These are just a few examples that illustrate the high use of synthetic pyrethroid s in urban settings and potential ecological
ramifications.

Budd et al. 2007 sampled sediments in mixed land (u rban and agricultural) in the San Diego Creek in Newport Bay Watershed in southern California. Bifenthrin and fenpropathrin were among the most frequently detected synthetic pyrethroids, with bifenthrin found in 95-100% of the sample s. According to the study...“Fenpropathrin was the second most frequently detected pyrethroid, found in 68% of the dry season samples and 90% of the wet season samples.” The highest concentrations were
associated with commercial nurseries. The authors found in this case that the concentration of synthetic pyrethroids was ge nerally lower in residential or commercial areas as opposed to agricultural sites. Als o, the frequency of detections of pyrethroids was higher during the wet season but the total co ncentration was not statistically different between the wet and dry seasons.

In addition, Weston et al. 2004 studied the presence of 26 pesticides, including five pyrethroids (but not includi ng fenpropathrin), in 70 sediment samples taken from the agriculture dominated Central Valley in Ca lifornia. Ten-day sediment tests were
conducted for Hyalella azteca and Chironomus dilutus (formerly known as Chironomus

tentans ), for some of the samples. Synthetic pyrethroids were found in 75% of the sediment samples; also they were found, based on a toxicity unit basis, to be sufficiently high to cause toxicity in 40% of the samples toxic to C. dilutus and around 70% of the samples toxic to H. azteca . The most commonly found pyrethroids were permethrin >

28esfenvalerate > bifenthrin > lambda-cyha lothrin. This study illustrates the high frequency of detections of synthetic pyrethro ids in sediments from agriculture dominated regions.

In a study, Gan et al. 2005 monitored the spa tial distribution and en richment (enrichment ratio, ER, or ratio of the con centration of a substance in eroded sediment to that of the source matrix) of the synthetic pyrethroids permethrin and bife nthrin, along a 260-m runoff path. A sedimentation pond was used as the source point for the study (permethrin and bifenthrin had been used extensively at the site, for ant control, in a nursery environment). It was observed that, in genera l, the sediment concentration of permethrin and bifenthrin increased with distance (dow nstream from the source). Using the source as the reference value, ERs were calculate d for these chemicals. The ER reached 25.7- 32.2 for bifenthrin at 145 m and beyond, and they were lower for permethrin. This article illustrates the possibility of enrichment of synthetic pyrethroids in sediment samples
downstream from the source.

Ding et al. 2010 conducted monitoring for 29 pes ticides, including pyrethroids like bifenthrin and fenpropathrin, from both ur ban and agricultural sites in central and
southern counties in the state of Illinois in 2008. Most of the urban samples were from constructed storm drains, while the agricultural samples were from small waterways between farmlands in areas where mostly corn and soybeans were grown and the major pesticides used were tefluthrin and atrazine. Furthermore, se diment toxicity tests towards Hyalella azteca were performed. In the urban samp les, the synthetic pyrethroids were detected in 95% of the samples. Bifenthrin was detected in 80% of the samples, while permethrin, lambda-cyhalothrin and fenpropathrin were also frequently detected. In the agricultural samples, bifenthrin, permethrin, cypermethrin and tefluthrin were detected (frequency of detection 47%), while fenpr opathrin and lambda-cyhalothrin were not detected. Ten of 17 urban sediment samples tested, were significantly more toxic to H.

azteca than the controls. Only one of the agri cultural sediment samples was significantly more toxic than the control. The major source of toxicity units (TUs) were the pyrethroids (in partic ular, bifenthrin). It was indi cated that the detections of fenpropathrin in the urban samples was unexpect ed because it is a pesticide primarily used in agriculture.

In a very recent article, Weston & Lydy 2010 studied the possible sources of pyrethroids in California’s Sacramento – San Joaquin Ri ver Delta, including urban runoff, municipal wastewater treatment plants (or Public ly Owned Treatment Works, POTWs), and agricultural discharges , in a study that focused on water samples (as opposed to most of
the studies above that are rela ted to sediments). Samples were taken during the wet and dry seasons. Urban runoff samples were take n from concrete sumps, from which pumps lift waters to adjacent rivers over levees . POTWs with secondary treatment were sampled just prior to discharge to surface wate rs. Agricultural discharges were collected at pump stations, where the runoff is lifted ove r the levees. Samples were tested for 8 pyrethroids and chlorpyrifos (LOQ around 1 ng/L for most samples). Tests to Hyalella

azteca were also performed at the temperature measured in the rive rs. Fenpropathrin was found in 3, 0 and 5% of the samples of urban runoff, POTWs and agricultural drains,

29respectively. The H. azteca EC50 for fenpropathrin was not available for comparison
with the concentrations. The maximum m easured fenpropathrin concentration was 6.1 ng/L, for an urban runoff sample. Through TIE, it was found that the toxicity was increased for most samples in the presence of PBO. A similar effect was observed when the temperature of the samples was decreased. In the presence of the enzyme E3, which is capable to degrade the pyrethroids, the effect was a decreased toxicity of the samples
towards H. azteca . In the presence of bovine seru m albumin (BSA), no effect on the toxicity of the samples towards H. azteca , was observed. The pyrethroid presence in POTWs was unexpected because the effluent s had low suspended material and the possible partitioning with biosolids within the plants. The authors indicated that possible sources of pyrethroids are sewer disposal of household insecticides, lice control shampoos, pet products and pe rmethrin treated clothing.

Sakata et al. 1990 studied the aerobic and anaerobi c metabolism of fenpropathrin in two Japanese soils for 24 weeks at 25oC in the dark. The reported half -lives were 11 and 17 days for the SCL and the light clay. In contrast, fenpropath rin was relatively stable in anaerobic and in sterile (autoclave) conditi ons. The degradates COOH-fenpropathrin and
CONH 2 –fenpropathrin were observed. It appears that sampling occurred only at 4, 8 and 24 weeks. Katagi 1993 studied the effect of soil moisture on soil surfaces containing the
chemical and irradiated with a xenon la mp (wavelengths above 290 nm, simulating natural sunlight), using three soils (CL, L a nd L), at 25oC for 14 da ys. Similar products were observed. The light appeared to enhance the rate of reaction. Akhtar et al. 2004 studied the persistence of ch lorpyrifos and fenpropathrin alone and in combination with various fertilizers at 28-30oC using soils from Pakistan in the dark and in flooded condition. Fenpropathrin was persis tent under the testing conditions.

Gan et al. 2008, calculated half-liv es of fenpropathrin and three other synthetic pyrethroids in two sediments unde r aerobic conditions. The half -lives for the total system were 89 and 152 days (for the SDC and BM sediments). 2 Furthermore, they provided

K OC ’s for several synthetic pyrethroids obtai ned using the solid phase microextraction sampling technique (SPME). For fenpropathrin, the mean corrected K OC , using the SPME was 12 times higher than the one published by Laskowski 2002. The mean
corrected K OC is 0.5x10 6 ( vs. 0.4x10 5 from Laskowski 2002). Li et al. 2009 studied the degradation of fenpropathrin a nd fenvalerate in an alkaline and in an acidic sterile (autoclave) and viable loam soils from Chin a at 22oC in the dark, using enantioselective HPLC. The degradation of fenpropathrin was slightly enantioselective. S-fenpropathrin degraded slightly faster under alkaline conditions. The calculated half-lives were 15.3 days and 16.2 days for S-fenpropathrin and R- fenpropathrin, respectively. In contrast, in the control, fenpropathrin dissipated very slowly ( ≤ 10% after 55 days). One experiment used the S-fenpropathrin enantiomer only. The analysis showed formation of Rfenpropathrin (racemization of the alpha carbon). This occurred both in the sterile and
viable alkaline soils. In th e acidic soils, the half-life for S-fenpropathrin was 31.1 days, with almost no degradation in the sterile so ils. No racemization was observed in the
acidic soils.

2 SDC is a sediment from the San Diego Creek (OC=1.4%) and BM is a sediment from a pond in Black Mountains in Paso Robles (Central CA) (OC=5.0%).

304. Receptors

4.1. Aquatic and Terrestrial Effects

The receptor is the biological entity th at is exposed to the stressor (EPA, 1998). Due to the outdoor uses of fenpropathrin, the types of receptors that may be exposed include both aquatic and terrestrial receptors, such as birds, reptiles, mammals, amphibians, freshwater and estuarine/ marine fish, non-ta rget terrestrial & aqua tic invertebrates and terrestrial & aquatic plants. This list may not be comprehensive. Spray drift and runoff exposures are expected for both ground a nd aerial applications of fenpropathrin. Consistent with the process described in the Overview Document (EPA, 2004), this risk assessment uses a surrogate species appro ach in its evaluation of fenpropathrin. Toxicological data generated from surrogate test species, which are intended to be representative of broad taxonomic groups, are us ed to extrapolate to potential effects on a variety of species (receptors) include d under these taxonomic groupings.

Tables 4.1 and 4.2 provide a summary of the taxonomi c groups and the surrogate species tested to help understand potential acute eco logical effects of pesticides to these nontarget taxonomic groups. In addition, the ta bles provide a preliminary overview of the potential acute toxicity of fenpropathrin by providing the ac ute toxicity classifications.

Terrestrial Species

In general, fenpropathrin appears to be sligh tly toxic to avian speci es but highly toxic to mammalian species on an acute level (LD 50 = 1089 mg/kg for avian species and 48.5 mg/kg for mammals) and also practically non -toxic to birds on a subacute level (LC 50s >5000 ppm). Chronic toxicity data show that exposure can result in reproductive effects (NOAEC/LOAEC = 25/125 ppm for Quail and 125/500 ppm for Mallard duck). Reproductive effects to mammals were noted with an LOAEL of 250 ppm and a NOAEL of 25 ppm. Toxicity to honeybees from resi dues on foliage suggests that fenpropathrin is toxic and produces high mortality to non-target insects (at 0.2 lbs ai/A mortality was >80% within the first 8-24 hrs of exposure).

Table 4.1 Summary of most sensitive endpoints fr om submitted terrestria l toxicity studies for fenpropathrin.

Species

(common

name) Taxa Represented Endpoint Mean
Concentration Test
Substance

(% a.i.) Citation

MRID Acute Toxicity
Classification

Mouse LD 50 48.5 mg/kg/bw Tech 127345 Highly Toxic

NOAEL 25 ppm Rattus norvegicus

(Laboratory Rat) Mammals

LOAEL 250 ppm Tech HED N/A

31Table 4.1 Summary of most sensitive endpoints fr om submitted terrestria l toxicity studies for fenpropathrin.

Citation Species Acute Test Taxa End- Mean (common

name) Represented point Concentration Substance (% a.i.) MRID Toxicity
Classification

Anas platyrynchos (Mallard duck) LD 50 1089 mg/kg bw 89 249939 Slightly toxic

Anas platyrynchos (Mallard duck) LC 50 9026 mg/kg diet 89 249939

NOAEC 25 mg/kg diet Colinus virginianus (Bobwhite

quail) Birds, terrestrialphase amphibians, and reptiles

LOAEC 125 mg/kg diet Tech 265374 Practically
nontoxic

Apis mellifera

(Honey bee) Terrestrial
invertebrates Residue Extended residual toxicity 30 133103 High mortality

Aquatic Species

In general, fenpropathrin is considered to be very highly toxic to fish and invertebrates (freshwater and estuarine/marine) on an acute basis. Acute toxicity studies on freshwater fish (LC 50s of 2.2 ppb for Bluegill and 5.5 ppb fo r Catfish) and invertebrates (EC 50 = 0.53 ppb) show that this compound is acutely very highly toxic to these organisms. In acute tests with estuarine fish and invertebrates, fe npropathrin was also considered very highly toxic to sheepshead (LC 50 = 3.1 ppb) and to mysid (LC 50 = 21 pptr) and fiddler crabs (EC 50 = 5.2 ppb). Chronic effects were noted in mysids (NOAEC = 0.012 ppb) as well as in fathead minnow (MATC = 0.091 ppb). A st udy (Pan and Liang 1993) using bog frog tadpoles ( Rana limnocharis ) found fenpropathrin to be very highly toxic on a subacute basis (LC 50 = 2.2 ppb). Studies using 2.4 EC spray (30% ai) resulted in very highly toxic LC50s of 7.7 ppb for Sunfish, 10 ppb for Ra inbow trout, 22 ppb for Catfish, 2.9 ppb for Daphnia, 15 ppb for Sheepshead minnow and 0.33 ppb for Mysid shrimp. All submitted aquatic TEP toxicity studies were less toxic than the parent TGAI.

32Table 4.2. Summary of most sensitive endpoints from submitted aquatic toxicity studies for fenpropathrin.

Species

(common name) Taxa Represented Endpoint Duration (hours) Mean
concentration

(μg a.i./L) Citation

MRID Acute Toxicity
Classification

Lepomis
macrochirus (Bluegill sunfish) LC 50 96 2.2 249939 Very highly
toxic

NOAEC 0.06 Pimephales promelas

(Fathead Minnow) Freshwater fishand aquaticphase amphibians

MATC 28 (days) 0.091 415259-01 N/A

EC 50 48 0.53 249939 Very highly
toxic

NOAEC 0.064 Daphnia magna

(Water Flea) Freshwater
Invertebrates

LOAEC 21 (days) 0.35 259678 N/A

Cyprinodon variegatus (Sheepshead

minnow) Estuarine/
Marine Fish LC 50 96 3.1 249939 Very highly
toxic

LC 50 96 0.021 409744-04 Very highly
toxic

NOAEC 0.012 Mysidopsis bahia

(Mysid shrimp) Estuarine/
Marine
Invertebrates

LOAEC 28 (days) 0.024 409744-07 N/A

Plants No aquatic or terrestrial plant data are available to the Agency for fenpropathrin.

ECOTOX Available open literature will be used to evaluate the potential direct effects of fenpropathrin to the terrestrial receptors identif ied in this section. This includes toxicity data on the technical grade active ingredient , and when available, formulated products ( e.g. “Six-Pack” studies).

At this time, a full and complete ECOTOX search has not been performed, but will be conducted prior to issuance of any Data Call-i n. The open literature studies will be identified through EPA’s ECOTOX database ( http://cfpub.epa.gov/ecotox/ ), which employs a literature search engine for locating chemical toxicity data for aquatic life, terrestrial plants, and wildlife. The evaluati on of data can also pr ovide insight into the direct and indirect effects of fenpropathrin on biotic communities from loss of species that are sensitive to the chemical and from changes in structure and functional characteristics of the affected communities. Open literature toxicity da ta for other ‘target’

33insect species (not includi ng bees, butterflies, beetles, and non-insect invertebrates including soil arthropods and worms), which include efficacy studies, are not currently considered in deriving the most sensitive endpoint for terrestrial insects. Efficacy studies do not typically provide endpoi nt values that are useful for risk assessment ( e.g. , NOAEC, EC50, etc.), but rather are intende d to identify a dose that maximizes a particular effect ( e.g. , EC100). Therefore, efficacy da ta and non-efficacy toxicological target insect data will not be included in the ECOTOX open literature search.

4.2. Incident Database Review

A preliminary review on January 27, 2010 of th e Ecological Incident Information System (EIIS, version 2.1), which is maintained by th e Agency’s Office of Pesticide Programs, and the Avian Monitoring Information System (AIMS), which is maintained by the American Bird Conservancy, indicates one repo rted ecological incide nt associated with the use of fenpropathrin. These incidents are summarized in Table 4.3. This total
excludes incidents classified as ‘unlikely’ and only includes those incidents with certainty categories of ‘highly probable’, and ‘probable’ and ‘possible’ (for EIIS) and ‘certain’, ‘highly likely’, ‘likely’, ‘proba ble’, and ‘possible’ (for AIMS). In the EIIS and AIMS databases, the “unlikely” category is used when a chemical is not lik ely to be responsible for the incident. For example, an ‘unlikely’ classification might be applied in situations where a given chemical is practically nontoxic to the category of organism killed and/or there is evidence that another pesticide or stressor likely caused the incident. Incidents classified as ‘unlikely’ for fe npropathrin will not be included in this Problem Formulation or the ecological risk assessment conducted for Registration Review.

One incident was reported for fenpropathrin (Danitol 2.4 EC) that occurred in Imperial
CA in 1996 and involved a fish kill. The inci dent (I004215-006 was classified as “highly probable”) involved hundreds of fish mortalities (shad, catfish and carp) after application of Fenpropathrin to cotton. Re sidue data were collected.

Table 4.3 Wildlife Incidents Associated with Fenpropathrin

Chemical

Name Incident
Number (Source) Taxa
Involved Magnitude Year Location (County,

State) Use Legality
of Use Certainty Category 1 Residues

Fenpropathrin EIIS
I004215-
006 Fish (Shad,
Catfish &

Carp) 200 1996 Imperial,
CA Cotton Registered

use Highly
Probable 36 ppb in gills 68 ppb in

tissue 1300 ppb

in soil sample
from bank

1 Incidents classified as ‘unlikely’ are excluded.

Although only a total of one incident for fenpr opathrin has been reported to the Agency, the absence of reported incident s should not be construed as the absence of incidents. Incident reports for non-target organisms t ypically provide information only on mortality events and plant damage incidents. Except for phytotoxic effects in terrestrial plants,

34sublethal effects for organisms such as re duced growth or impaired reproduction are rarely reported. EPA’s changes in the registrant reporting re quirements for incidents in 1998 may account for a reduced number of reporte d incidents. Registrants are now only required to submit detailed information on ‘maj or’ fish, wildlife, and plant incidents. Minor fish, wildlife, and plant incidents, as well as all other nont arget incidents, are generally reported aggregately a nd are not included in EIIS. In addition, there have been changes in state monitoring efforts due to lack of resources.

In the risk assessment, the incident will be fu rther evaluated to determine if it represents current patterns of use for fenpropathrin. Examples of additional considerations are mitigation ( e.g ., reduced application rates), product cancellations, and changes in use patterns that have occurred since th e date of the reported incidents.

As it has been indicated earli er, fenpropathrin is not among the constituents monitored by the National Water Quality Assessment Data Warehouse, (NAWQA) maintained by the U.S. Geological Survey; however, multiple ar ticles from the literature document the presence of synthetic pyreth roids like fenpropathri n in both urban and agricultural sediments (refer to Section 3.4 ).

4.3. Ecosystems Potentially at Risk

Fenpropathrin may be applied on a variety of food crops, including head & stem brassica, citrus, cotton, cucurbit & fr uiting vegetables, grapes, peanut, tree nut, stone & pome fruits, strawberries, bushberries, caneberries, currant, peas, olives, barley and tropical fruits. In addition, it may be used in various non-food sites ( e.g. agricultural uncultivated areas, deciduous fruit trees, fo rest trees, ornamental and/ or shade trees, ornamental herbaceous plants, ornamental non-flowering plants, and ornamental woody shrubs and vines). Thus, the ecosystems at risk may be ex tensive in scope, and as a result it may not be possible to identify specific ecosystems during the development of a baseline risk assessment. In general terms, terrestrial eco systems potentially at risk due to the use of fenpropathrin, could include the treated fiel d and areas immediately adjacent to the treated field that may receive drift or runoff. Areas adjacen t to the treated field could include cultivated fields, fencerows a nd hedgerows, meadows, fallow fields or grasslands, woodlands, riparian habi tats and other uncultivated areas.

Due to the persistence of fenpropathrin, it is expected to drift and/ or runoff due to application to food crops, resu lting in possible exposure to aquatic ecosystems. Aquatic ecosystems potentially at risk due to th e use of fenpropathrin include water bodies adjacent to, or down stream from, the trea ted field and might include impounded bodies such as ponds, lakes and reservoirs, or flowi ng waterways such as streams or rivers. For uses in coastal areas, aquatic habitat also in cludes marine ecosystems, including estuaries.

5. Assessment Endpoints

Assessment endpoints are defined as “explicit expressions of the ac tual environmental value that is to be protected.” Defining an assessment endpoint involves two steps: 1)

35identifying the valued attributes of the envir onment that are considered to be at risk; and 2) operationally defining the assessment endpoi nt in terms of an ecological entity ( i.e. , a community of fish and aquatic inve rtebrates) and its attributes ( i.e. , survival and reproduction). Therefore, selection of th e assessment endpoints is based on valued entities ( i.e. , ecological receptors), th e ecosystems potentially at risk, the migration pathways of pesticides, and the routes by which ecological receptors are exposed to pesticide-related contamination. The selecti on of clearly defined assessment endpoints is important because they provide direction a nd boundaries in the ri sk assessment for addressing risk management issues of c oncern. Changes to assessment endpoints are typically estimated from the available toxicity studies, which are used as the measures of effects to characterize potentia l ecological risks associated with exposure to pesticides, such as fenpropathrin.

To estimate exposure concentra tions, the ecological risk as sessment considers a single application at the maximum application rate to fields that have vul nerable soils. The most sensitive toxicity endpoints are used from surrogate test species to estimate
treatment-related direct eff ects on acute mortality and chr onic reproductive, growth and survival assessment endpoints. Toxicity te sts are intended to determine effects of pesticide exposure on birds, mammals, fish, te rrestrial and aquatic invertebrates, and plants. These tests include short-term acu te, sub-acute, and repr oduction studies and are typically arranged in a hierarchical or tiered system that progresse s from basic laboratory tests to applied field studies. The toxicity st udies are used to evaluate the potential of a pesticide to cause adverse effects, to determ ine whether further tes ting is required, and to determine the need for precautionary label st atements to minimize the potential adverse effects to non-target animals and plants.

An open literature search will be conducted to determine any relevant endpoints. The search will focus on survival, growth and repr oductive effects for a quatic and terrestrial effects of fenpropathrin. More sensitive endpoi nts from acceptable open literature studies
will be included in this risk assessment.

6. Conceptual Model

For a pesticide to pose an ecological 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 pathway to be complete, 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.

A conceptual model provides a written desc ription and visual re presentation of the predicted relationships between fenpropathri n, potential routes of exposure, and the predicted effects for the assessment endpoint. A conceptual model consists of two major components: risk hypothesis and a conceptual diagram (EPA, 1998).

366.1. Risk Hypothesis

Risk hypotheses are specific assumptions about potential adverse effects ( i.e. , changes in assessment endpoints) and may be based on theory and logic, empirical data, mathematical models, or probability models (E PA 1998). For this assessment, the risk is stressor-initiated, where the stressor is the re lease of fenpropathrin into the environment. The following risk hypothesis is presumed for this screening-level assessment:

Fenpropathrin and its residues, when used in accordance with registered labels, will likely lead to off-site movement of the compound via runoff, spray drift, and eroded soil leading to exposure of nont arget plants and animals Based on information on the environm ental fate, mode of action, direct toxicity and potential indirect effects, EFED assumes that registered us es of fenpropathrin have the potential to cause reduced survival, growth, and reproduction to nontarget terrestrial and/ or aquatic animals and plants.

The conceptual model is a generic graphic de piction of the risk hypothesis. It includes the potential pesticide or stressor (fenpropath rin and its possible resi dues of concern), the source of the pesticide and/ or transport pathways, expos ure media, exposure point, biological receptor types, and attribute changes.

6.2. Conceptual Diagram

The conceptual site model is a generic gr aphic depiction of the risk hypothesis, and assumes that the insecticide fenpropathri n, a Type II syntheti c pyrethroid, having multiple agricultural and non-agricultural us es, is capable of affecting aquatic and terrestrial animals provided that environmental concentrations are sufficiently elevated as a result of proposed label uses. Based on an examination of the physicochemical properties of fenpropathrin, the fate and dis position in the environment, and mode of application, a conceptual mode l was developed that represen ts the possible relationships between the stressors, ecological receptor s, and the assessment endpoints. Through a preliminary iterative process of examining available data, the conceptual model ( i.e ., the representation of the risk hypothesis) may be refined to reflect the likely exposure pathways and the organisms that are most rele vant and applicable to this assessment (see Figures 6.1a and 6.1b , below). They include the pot ential pesticide or stressor (fenpropathrin, but the presence of toxicologi cally important metabolites cannot be ruled out), the sources and/ or transport path ways, exposure media and exposure points, biological receptor types and attribute changes.

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 complete, it must have a source, a release mechanism, an environmental transport medium, a point of exposure for ecologi cal receptors, and a

37feasible route of exposure. In addition, the potential m echanisms of degradation/ transformation ( i.e. , which degradation/ transformation products may form in the environment, in which media, and how much ) must be understood, especially if for the chemical, its metabolites/ tran sformation products are of gr eater toxicological concern than the parent compound (note, that for fe npropathrin, at this time, no major metabolites have been identified). The assessment of ecological exposure pathways, therefore, includes an examination of the source and pot ential migration pathways for constituents, and the determination of potential exposure routes.

Under the possible uses of fenpropathrin, the sources and mechanisms of release of the compound are from ground or aerial spray applic ations (note that this conceptual model considers agricultural applica tions as well as certain non-ag ricultural applications). Surface runoff from the areas of application is assumed to depend on factors such as topography, irrigation, and rainfall events. Direct deposition may result in contamination of food items that may be consumed by terres trial organisms. Spray drift results in contaminated adjacent areas, including bodies of water. Leaching to groundwater is not considered an important source because fenpropathrin is highly immobile. Due to fenpropathrin’s physicochemical properties (vap or pressure and Henry’s Law constant), atmospheric transport appears unlikely. Fu rthermore, the estimated hydroxyl radical
reaction half-life es timated by EpiSuite v.4.0 is only 0.599 days. It appears that fenpropathrin would not persist in the e nvironment for extended periods of time.

For aquatic receptors, the major point of expos ure is through direct contact with the water column, sediment, and pore water (gill/ integum ent) contaminated with spray drift (from spray application) and/ or runoff from treated areas. Indirect effects to aquatic organisms (both fish and aquatic inverteb rates) can also occur through impact to various food chains (it was established earlier in this document that fenpropathrin has the potential to bioaccumulate/bioconcentrate). The repres entative aquatic receptors are certain freshwater and estuarine/ marine fish, inverteb rates, and, in certain cases, aquatic plants. The major point of exposure fo r terrestrial animals is cons umption of food contaminated with residues such as grass, foliage, and sma ll insects. For plants, the point of exposure is direct contact or root uptake. The repr esentative terrestrial receptors are mammals, birds and terrestrial plants. The attribute changes used to assess risk to terrestrial receptors depend on the type of test ( e.g. , reduced survival, growth, or reproduction for animals and seedling emergence and vegetative vi gor for plants). It should be noted, that these species do not cover all the possible species in the animal and plant kingdoms; certain taxa are considered as surrogates for other taxa. For example, fish are considered surrogates for aquatic phase amphibians.

This conceptual model also shows details about biomagnification for a chemical (see piscivorous birds and mammals in Fig. 6.1a ). Fenpropathrin has a very high K OW and according to its physicochemical and fate properties, there is a potential for bioaccumulation/ bioconcentration in aqua tic organisms, and biomagnification in terrestrial organisms.

Fenpropathrin shows a very low solubility, a very high K OW and also high K OC ’s. These

38properties suggest that the chemical partitions with sediments, and with organic matter suspended in the water bodies. Fenpropathrin is likely to concentrate in the sediments, where it could persist. Such sediments coul d serve as repositories of the chemical for extended periods of time and could potentially be toxic to sediment dwelling organisms, affecting the food chain. This potential for toxicity will also be assessed in the risk assessment for fenpropathrin.

**Route of exposure includes only ingestion of fish and aquatic inverts. 

### Stressor

Source

Receptors

Attribute Change Fenpropathrin applied to agricultural or non-agricultural use sites

Spra y drift

Aquatic animals
Invertebrates
Vertebrates
**Piscivorous mammals
and birds

Individual organisms
Reduced survival Reduced growth Food chain Reduction in algae and vascular plants Reduction in prey Modification of PCEs related to prey availability Habitat integrity Reduction in primary productivity
Reduced cover Community change Modification of PCEs related to
habitat Surface water/ Sediment Runoff

Aquatic Animals
Invertebrates
Vertebrates Uptake/gills or integument

In g estion Ingestion Atmospheric transport

Wet/dry deposition Soil Leaching to Groundwater

Uptake/gills or integument

Aquatic Plants
Non-vascular
Vascular Uptake/cell, roots, leaves Riparian plants
terrestrial

exposure pathways; see

Figure 6.1b 

### Exposure
Media

Figure 6.1a. Conceptual model depicting stressors, exposure pathways, and potential effects to aquatic organisms from the use of fenpropathrin on agricultural and certain non-agricultural sites Dotted lines indicate exposure pathways that have a low likelihood of contributing to ecological risk.

39Stressor

Source

Attribute Change Fenpropathrin applied to agricultural or non-agricultural use sites

Direct application Spray drift

Terrestrial
vertebrates Terrestrial
invertebrates

Individual organisms Exposure Media & Receptors

Reduced survival Reduced growth Reduced reproduction Food chain Reduction in prey and food Modification of PCEs related to prey availability Habitat integrity Reduction in primary productivity
Reduced cover Community change Modification of PCEs related
to habitat Terrestrial plants grasses/ forbs, fruit, seeds (trees, shrubs) Runoff

Terrestrial
vertebrates Soil

Ingestion Ingestion Ingestion Dermal uptake/Ingestion Atmospheric transport

Root uptake/contact

Wet/dry deposition

Ingestion Leaching to Groundwater Irrigation

water

Figure 6.1b. Conceptual model depicting stressors, exposure pathways, and potential effects to terrestrial organi sms from the use of fenpropathrin on agricultural and certain non-agricultural sites Dotted lines indicate exposure pathways that have a low likelihood of contributing to ecological risk.

7. Analysis Plan

In order to address the ri sk hypothesis, the potential for adverse effects on the environment is estimated. Usage, environm ental fate and trans port, and ecological effects of fenpropathrin are char acterized and integrated to assess the risks. This is accomplished using a risk quotient (ratio of exposure concentration to effects concentration) approach. Although risk is often defined as the likelihood and magnitude of adverse ecological effects, the risk quotient-based approach does not provide a quantitative estimate of likelihood and/ or magnitude of an adverse effect. However, as outlined in the Overview Document (USE PA 2004), the likelihood of effects to individual organisms (i.e., for assessing risks to listed species) from particular uses of a chemical is estimated using the probit dose-resp onse slope and either the level of concern (discussed below) or the actual cal culated risk quotient value.

40This analysis plan will be revisited and may be revised de pending on the data available in the open literature and the information submitted by the public in response to the opening of the Registration Review docket.

7.1. Stressors of Concern

The focus of this assessment is on the pa rent material, fenpropathrin. However, the Agency will review open literature to identi fy degradate(s) of potential toxicological concern ( e.g. 4’-OH-fenpropathrin and other transf ormation products were observed in certain terrestrial field dissipa tion studies). If degradates of toxicological concern are identified, they will also be considered as part of the stressor of concern.

Toxicity data for environmental mixtures of fenpropathrin with other pesticides (those mixtures occurring in the environment followi ng application), if available, may be presented as part of the ecological risk asse ssment. Fenpropathrin may be applied in tank mixtures with other products approved for use on registered crops. It is expected that the toxic effect of fenpropathrin, in combinat ion with other pesticides used in the environment, is likely to be a function of many factors including, but not necessarily limited to: (1) the exposed species , (2) the co-contaminants in the mixture, (3) the ratio of fenpropathrin and co-contaminant concentra tions, (4) differences in the pattern and duration of exposure among contaminants, a nd (5) the differential effects of other physical/ chemical characteristic s of the receiving waters ( e.g. organic matter present in sediment and suspended water). Quantitative ly predicting the combined effects of all
these variables on mixture t oxicity to any given taxa with confidence is beyond the capabilities of the available data and methodologies. Howeve r, a qualitative discussion of implications of the available pesticide mixture effects data on the confidence of risk assessment conclusions will be addressed as part of the uncertainty analysis.

7.2. Measures of Exposure

In order to estimate risks of fenpropathri n exposures in aquatic and terrestrial environments, all exposure modeling and resul ting risk conclusions will be made based on maximum application rates fo r the current use patterns. Measures of exposure are based on aquatic and terrestrial models that predict estimated environmental concentrations of fenpropathrin using maximu m labeled application rates and methods, as well as any mitigation measures specifically in dicated on the label. The models used to predict aquatic EECs are the Pesticide Root Zone Model coupled with the Exposure Analysis Model System (PRZM/EXAMS). The model used to predict terrestrial exposure is T-REX. The model used to deri ve EECs relevant to terrestrial and wetland plants is TerrPlant. The pot ential for bioaccumulation for the chemical is assessed using the KABAM model, as well the results from bioconcentration in fish studies (the bioconcentration factors). These models ar e parameterized using relevant reviewed registrant-submitted environmental fate and transport data.

PRZM (v.3.12.2, May 2005) and EXAMS (v.2.98.4.6, April 2005) are screening simulation models coupled with the input sh ell PE5.pl (August, 2007) to generate daily

41exposures and 1-in-10 year EECs of fenpropath rin, that may occur from spray drift and runoff to surface water bodies adjacent to app lication sites. PRZM simulates pesticide application, movement and transformation on an agricultural fiel d and the resultant pesticide loadings to a recei ving water body via runoff, erosion and spray drift. The EXAMS model simulates the fate of the pesticide and resulting concentrations in the water body. The standard scenario used fo r ecological pesticide assessments assumes application to a 10-hectare agri cultural field that drains in to an adjacent 1-hectare water body that is 2 meters deep (20,000 m 3 volume) with no outlet. PRZM/ EXAMS is used to estimate screening-level exposure of aqua tic organisms to fenpropathrin and/ or its transformation products, should they be of c oncern. The measure of exposure for aquatic species is the 1-in-10 year re turn peak or rolling mean c oncentration. The 1-in-10 year peak is used for estimating acute exposures of direct effects to aquatic organisms. The 1- in-10-year 60-day mean is used for assessi ng chronic exposure to fi sh and aquatic-phase amphibians. The 1-in-10-year 21-day mean is used for assessing aquatic invertebrate chronic exposure.

Given the aquatic toxicity of fenpropathrin and its likeli hood to occur in sediment, the Agency will also consider the potential exposures resulting fro m benthic/ sediment concentrations (EECs). Pore water concentrations are commonly used to predict toxicity
of non-ionic substances in sediments and ch aracterize exposure to organisms that spend time in or near sediments (Di Toro et al. 1991; US EPA 2002). PRZM/ EXAMS estimates 1-in-10-year peak and 21-day mean EECs for pore water.

Exposure estimates for terrestrial animals assumed to be in the targ et area are derived using the T-REX model (version 1.3.1, 12/ 07/2006). For pesticides such as fenpropathrin, which can be applied as a dust, this includes the am ount of pesticide per square foot, used in LD 50 per square foot risk assessment calculations. EECs for terrestrial plants inhabiting dry and wetland areas are derived usi ng TerrPlant (version 1.2.2, 12/26/2006). This model uses estimates of pesticides in runoff and in spray drift (assumed to be 0% for granulars) to calc ulate EECs. EECs are based upon solubility, application rate and mini mum incorporation depth.

As indicated in Table 3.1 , and its associated text in Section 3 , fenpropathrin appears to have a potential to bioconcentr ate in aquatic organisms & biomagnify in aquatic and terrestrial organisms. The potential for bioaccumulation of fenpropathrin will also be examined in the risk assessment. Because fenpropathrin has a fairly high K OW (1.00 x
10 6 ) and the chemical may be persistent in wa ter and sediments, there is a potential for
bioaccumulation. The bioconcentration factors ranged from 200x (fillet) to 1400 (viscera) and depuration rate is moderate (by day 21 of depuration, 78-84% of the residues had been
eliminated from th e fillet, MRID 1616 72, 163521). Bio accumulation will be assessed using the results from bioaccumulation in fish studies, as well as the KABAM model (KOW (based) Aquatic BioAccumulation Mo del, version 1.0, 2009), adjusting for
biotransformation rates. KABAM is used to estimate potential bioaccumulation of hydrophobic organic pesticides in freshwater aquatic ecosystems and risks to mammals and birds consuming aquatic organisms which have bioaccumulated these pesticides.

427.3. Measures of Effect

Ecological effects data are used as measures of direct and indirect effects to biological receptors. Data are typically obtained from registrant-submitted studies or from literature studies identified by ECOTOX. The ECOTOX da tabase provides more ecological effects data in an attempt to bridge existing data gaps. ECOTOX is a source for locating single chemical toxicity data and potential chemi cal mixture toxicity data for aquatic life, terrestrial plants, and wildlife. ECOTOX wa s created and is maintained by the USEPA,
Office of Research and Devel opment, and the National Health and Environmental Effects Research Laboratory's Mid- Continent Ecology Division.

The acute measures of effect used fo r animals in this assessment are the LD 50 , LC 50 and
EC 50 . LD stands for "Lethal Dose", and LD 50 is the amount of a material, given all at once, that is estimated to cause the death of 50% of the test organisms. LC stands for
“Lethal Concentration” and LC 50 is the concentration of a chemical that is estimated to kill 50% of the test organisms. EC stands for “Effective Concentration” and the EC 50 is
the concentration of a chemical that is estim ated to produce a specific effect in 50% of the test organisms. Endpoints for chronic measures of exposure for listed and non-listed
animals are the NOAEL/NOAEC and NOEC. NOAEL stands for “No ObservedAdverse-Effect-Level” and refers to the highest tested dose of a subs tance that has been reported to have no harmful (adverse) e ffects on test organisms. The NOAEC ( i.e. , “NoObserved-Adverse-Effect-Concentration”) is the highest test concentr ation at which none of the observed effects were statistically diffe rent from the control. The NOEC is the NoObserved-Effects-Concentration. For non-li sted plants, only acute exposures are assessed ( i.e. , EC 25 for terrestrial plants and EC 50 for aquatic plants); for listed plants
either the NOAEC or EC 05 is used.

Information on the potential effects of fe npropathrin on non-target animals is also collected from the Ecological Incident Informa tion System (EIIS). The EIIS is a database containing adverse effect (typ ically mortality) reports on non-target organisms where
such effects have been associated with th e use of pesticides. Information on incidents involving avian species is al so provided through the Av ian Monitoring Information System (AIMS), which is maintained by the American Bird Conservancy.

Where available, sub-lethal effects observed in both registrant-submitted and open literature studies will be evaluated qualitat ively. Such effects may include behavioral changes ( e.g. , lethargy and changes in coloration). Quantitative assessments of risks, though, are limited to those endpoints that ca n be directly linked to the Agency’s assessment endpoints of impaired survival, growth and reproduction.

The assessment of risk for direct effects to non-target organisms makes the assumption that the toxicity of fenpropathrin to birds is similar to terrestrial-phase amphibians and reptiles. The same assumption is made for fish and aquatic-phase amphibians.

437.4. Integration of Exposure and Effects

Risk characterization is the integration of exposure and ecological e ffects characterization to determine the potential ecologi cal risk from the use of pe sticides and the likelihood of
direct and indirect effects to non-target organisms in aquatic and terrestrial habitats. The exposure and toxicity effects data are integrated in order to evaluate the risks of adverse ecological effects on non-target species. For the assessment of risks, the risk quotient (RQ) method is used to compare exposure and measured toxicity values. EECs are divided by acute and chronic toxicity values. The resulting RQs are then compared to the Agency’s Levels of Concern (LOCs) (USEPA 2004). These criteria will be used to indicate when fenpropathrin’s us es, as directed on the label, have the potential to cause
adverse direct or indirect eff ects to non-target organisms. In addition, incident data from the EIIS will be considered as part of the risk characterization.

7.5. Deterministic and Probabilistic Assessment Methods

The quantitative assessment of risk will primarily depend on the deterministic pointestimate based approach described in the risk a ssessment. An effort may also be made to further qualitatively describe ri sk using probabilistic tools th at the Agency has developed. These tools have been reviewed by FIFRA Scientific Advisory Panels ( http://www.epa.gov/sc ipoly/sap/index.htm ) and have been deemed as appropriate means of refining assessments where deterministic approaches have identified risks.

7.6. Endangered Species Assessments

Consistent with the Agency’s responsibility under the Endangered Species Act (ESA), the Agency will evaluate risks to Federally-listed threatened and/or endangered (listed) species from registered uses of fenpropathrin. This assessment will be conducted in accordance with the Overview Document (USE PA 2004), provisions of the ESA, and the
Services’ Endangered Species C onsultation Handbook (USFWS/NMFS, 1998).

The assessment of effects associ ated with the registration of fenpropathrin is based on an
action area. The action area is considered to be the area directly or indirectly affected by the federal action, as indicated by the exceedan ce of Agency Levels of Concern (LOCs)
used to evaluate direct or indirect effects. The Agency’s approach to defining the action area under the provisions of the Overview Do cument (USEPA 2004) considers the results of the risk assessment process to estab lish boundaries for that action area with the understanding that exposures below the Agency’s defined LOCs constitute a no-effect threshold. For the purposes of this assessmen t, attention will be focused on the footprint of the action ( i.e. , the area where fenpropathrin applica tion occurs), plus all areas where offsite transport may result in potential e xposure that exceeds the Agency’s LOCs. Specific measures of ecological effect that de fine the action area for listed species include any direct and indirect effects and/ or pot ential modification of its critical habitat, including reduction in survival, growth, and reproduction as well as the full suite of sublethal effects available in the effects literature. Therefore, the action area extends to a point where environmental exposures are below any measured lethal or sub-lethal effect

44threshold for any biological entity at the w hole organism, organ, tissue, and/or cellular level of organization. In situa tions where it is not possible to determine the threshold for an observed effect, the action ar ea is not spatially limited and is assumed to be the entire
United States.

Probit Slope Analysis The probit slope response relationship is ev aluated to calculate the chance of an individual event corresponding to the listed species acute LOCs. If information is unavailable to estimate a slope for a partic ular study, a default slope assumption of 4.5 is used as per original Agency assumptions of typical slope cited in Urban and Cook (1986).

a. Terrestrial Species Terrestrial acute toxicity studies for fenpropa thrin did provide raw da ta and estimates of slopes for avian species. Analysis of raw data provided a slope of 2.0 from an acute toxicity study using the Mallard Duck. Ba sed on this slope, the corresponding estimate chance of individual mortality following exposure is 1 in 44.

b. Aquatic Species Acute toxicity studies for fenpropathrin did pr ovide raw data and estimates of slopes for fish and aquatic invertebrate sp ecies. Analysis of raw data fr om the aquatic acute toxicity studies provided slopes of 3.1 for freshwater fish, 2.75 for freshwater invertebrates (daphnia) and 2.69 for estuarine/marine inverteb rates (mysid). Based on these slopes, the corresponding estimate chance of indi vidual mortality following exposure is 1 in 3.63 x
10 4 for freshwater fish, 1 in 5.77 x 10 3 for freshwater inverteb rates, and 1 in 4.24 x 10 3

for estuarine/marine invertebrates.

7.7. Drinking Water Assessment

A drinking water assessment will be conducte d to support future human health risk assessments of fenpropathrin should it be re quired. The drinking water assessment will incorporate model estimates of fenpr opathrin in surface and ground waters.
Concentrations in surface waters will be estimated using FQPA Index Reservoir Screening Tool (FIRST, v.1.1.1, 12/18/07) (or subsequently using PRZM/EXAMS, with the Index Reservoir - see description above, if refinements are re quired). Ground water
estimates of concentrations will be estimat ed using the Screening Concentration in Ground Water (SCI-GROW) model (v.2.3, July 2003). The drinking water assessment will also include a summary of availabl e surface and ground water monitoring data.

7.8. Endocrine Disruptor Screening Program

As required under FFDCA section 408(p), EP A has developed the Endocrine Disruptor Screening Program (EDSP) to determine whet her certain substances (including pesticide active and other ingredients) may have an effect in humans or wildlife similar to an effect produced by a “naturally occurring estrogen, or other such endocrine effects as the Administrator may designate.” The EDSP em ploys a two-tiered approach to making the

45statutorily required determinations. Tier 1 cons ists of a battery of 11 screening assays to identify the potential of a chemical substan ce to interact with th e estrogen, androgen, or thyroid (E, A, or T) hormona l systems. Chemicals that go through Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA will determine which, if any, of the Tier 2 tests are necessary based on the available data. Ti er 2 testing is designed to identify any adverse endocrine related effects caused by th e substance, and esta blish a dose-response relationship between the dose a nd the E, A, or T effect.

Between October 2009 and February 2010, EPA issu ed test orders/data call-ins for the first group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. This list of chemicals was selected based on the potential for human exposure through pathways such as food and wa ter, residential activity, and certain postapplication agricultural s cenarios. This list should not be construed as a list of known or likely endocrine disruptors.

Fenpropathrin is not among the group of 58 pestic ide active ingredients on the initial list
to be screened under the EDSP. Under FFDCA sec. 408(p) the Agency must screen all pesticide chemicals. Accordingly, EPA anticip ates issuing future EDSP test orders/data call-ins for all pesticide active ingredients.

For further information on the status of the ED SP, the policies and procedures, the list of 67 chemicals, the test guidelines and the Tier 1 screening battery, please visit our
website: http://www.epa.gov/endo/

.

7.9. Preliminary Identification of Data Gaps

7.9.1. Fate

After evaluation of the available data for fenpropathrin, the following are the data gaps for registration review:

835.2240 Aqueous Photolysis – The available study was performed in the presence of high levels of cosolvent acet onitrile (around 8%). The study indicated that fenpropathrin
was stable under the testi ng conditions. Supplemental da ta from other previously reported studies, indicated half-lives rangi ng from 1.6 to around 113 days (data reported by Laskowski 2002, half-lives ranging from 14.6 to 87.5 days). There is a high level of uncertainty with respect to the levels of photol ysis and there are no re liable data related to the possible transformation products. A ne w study is required to clarify these
uncertainties.

835.4100 Aerobic Soil Metabolism – At this time the Agency has studies performed in one soil (152 days, SiL). Further supplemental data indicated the following estimates of half-lives: 33-35 days (light clay) and 34-39 days (SCL). This early study was conducted for only 30 days (required 365 days). Hi gh variability in the results from the

46supplemental study conducted earl ier (with shorte r half-lives) vs. the most recent study brings uncertainty to the environmental fate assessment. Furthermore, aerobic soil metabolism half-lives, reported by Laskowski 2002, are 34.1, 32.1, 34.8, 36.5, 39.4, 133, 34.7, 51.3, 221 & 186 days for SCL, C, SCL, C, SL , C, SL, SC, SC & L soils. Rates of transformation should be determined in four soils. The registrant should submit a study conducted in three soils; a sandy loam soil should be included.

835.4200 Anaerobic Soil Metabolism – The available study was performed with only one soil and for a period of roughly 2 months of anaerobic incubation (with a reported half-life of 186 days, for a L soil). Other half-lives, reported by Laskowski 2002, are 283 & 383 days for C & SCL, respectively. Anaer obic studies with one soil type are generally sufficient for the evaluation of transformation pathways. Rates of
transformation should be determined in at least three additional soils (from Fate, Transport and Transformation Test Guidelines – OPPTS Guideline 835.4100 &
835.4200 ). The study indicates that after the soil was flooded (converted to anaerobic), the metabolism was very low. Data perfor med for a longer period of time will help the Agency to determine rates of transformation and presence of possible metabolites.

835.4300 Aerobic Aquatic Metabolism – No study has been submitted. Gan et al. 2008, calculated half-lives of fenpropathrin and three other synthetic pyrethroids in two
sediments under aerobic conditions. The half- lives for the total system were 89 and 152 days (for the San Diego Creek – SDC, and a pond in Black Mountains – BM, sediments). According to OPPTS Guideline 835.4300 and 835.4400 , “At least two sediments and
their associated waters are used for both the aerobic and the anaerobic studies respectively (see paragraph (h)(1 0) of this guideline). However, there may be cases where more than two aquatic sediments should be used, for example, for a chemical that may be present in freshwater and/or ma rine environments. Sediments should be representative of intended us e sites.” As discussed in Section 3.2 , on pesticide use and usage, there is the potential for use of fenpropa thrin near estuarine/ marine environments. The study is required.

835.4400 Anaerobic Aquatic Metabolism – Two studies are available, performed in only one soil type (yielding half-liv es of 78 and 67 days in a CA L). These studies are currently in review. Other half-lives , reported by Laskowski 2002, are 93.4, 85 & 57.8 days for L, L & SL, respectively. According to OPPTS Guideline 835.4300 and
835.4400 , “For the strictly anaerobic study, two sediments (including their associated waters) should be sampled from the anaerobic zones of surface water bodies...” A study is available in only one soil system. A study conducted in at least one additional sediment type is required.

835.1230 Mobility Adsorption/ Desorption – The available study was performed at a single concentration and no Fre undlich correlations are available. An update or upgrade of the study is currently in review; it contains data on one additional soil (a loam). This data requirement is considered unfulfilled unt il the update/ upgrade study is reviewed and deemed acceptable.

47Environmental Chemistry Methods (ECMs), and Independent Laboratory Validations (ILVs), for Soil, Water and Sediment . ECMs associated with the Terrestrial Field Dissipation study (Field dissipation §158.1300; OPPTS guidelines 835.6100, 835.6200, and 835.6300), along with successful confirmatory method trials (validation) by an inde pendent laboratory ( i.e. ILVs), are required. If there is risk concern for a given taxon, ECMs should be av ailable for the environmental media in which organisms of the taxon reside. These ECMs should have limits of quantization for
the residues of concern that are lower than the relevant toxico logical levels of concern. Previous reviews on fenpropathrin indicate th at there is high concern for acute and chronic aquatic toxicity. Certain scenarios may have triggered acute and chronic levels
of concern for freshwater and/ or estuarine/ marine aquatic in vertebrates and/ or for fish. In addition, the latter risk assessments conducted on fenpropathri n, indicated risk concerns for organisms living in the benthos . Therefore, ECMs for water and sediment are required in addition to the ECM for soil. The ECMs should include parent and those residues found in the laboratory studies that exceeded 10% of the applied. Based on the available data, the following appear to be the residues of concern for each media, but this could change, based upon the results of the other environmental fate studies: Soil – parent, PBA, CONH 2 -fenpropathrin and COOH-fenpropathrin Water – parent, PBA, CONH 2 -fenpropathrin Sediment – parent and possible metabolites The registrant is encouraged to submit stat e-of-the-art environmental chemistry methods; further, multi-residue methods (MRMs) for so il, water and sediment are preferred, if applicable. The registrant submitted one method for soil (MRID 41679601, LOD 0.01 ppm, published in the Agency’s ECM website) 3 is available, that could quantify fenpropathrin and its metabolites 4’-OH-fenpropathrin and desphenylfenpropathrin in soil, using GC with a nitrogen/ phosphorous fl ame ionization detector. These levels of quantization may not be appropriate. Furthermore, the following studies have been
located and are curre ntly in review: MRIDs 71368 & 100138, 126817, 126818, 43958802 and 43958803 (the latter two studies ar e ILVs), and 47053001 and 47053002 (ECM and ILV). A full description of the method validation procedures performed by an independent laboratory should also be submitted. These reports will be evaluated by EFED. According to NAFTA Guidance (Corbin et al. 2006), they should include the following information: (a) Recovery level(s) of the test compound(s) from the soil, water and sediment (substrates) at various relevant fortificati on level(s) using the residue analytical methodology; (b) a va lidated method sensitivity leve l; (c) results of the study and statistical test applied, including a st epwise presentation of the procedure for calculating percent recovery from the raw data; (d) all the data/ information necessary to independently verify the resu lts; (e) summary of the resu lts; and, (f) discussion and
conclusions of the results. This data re quirement is considered unfulfilled until the
studies mentioned above are reviewed.

3 Available at url: http://www.epa.gov/oppbead1/methods/ecmindex.htm

48Table 7.1 lists the status of the environmental fate data requirements for fenpropathrin.

Table 7.1. Summary of Environmental Fate Data Requirements for Fenpropathrin

Study Identification Use
Pattern 1 Does EPA Have Data To Satisfy This Requirement? Bibliographic Citation Must Additional
Data Be Submitted
Under FIFRA

3(c)(2)(B)?

§158.1300 ENVIRONMENTAL FATE

Degradation Studies-Lab :

835.2120 Hydrolysis 1,2 Yes 131438, 141320,
42599901 No

835.2240 Photodegradation in

Water 1,2 Yes 43917227 Yes 2

835.2410 Photodegradation on
Soil 1,2 Yes 137769, 42546402 No

835.2370 Photodegradation in
Air 1,2 No Not Available Waived 3

Metabolism Studies-Lab :

835.4100 Aerobic Soil 1,2 Yes 126823, 130869, 142547, 42525902 Yes 4

835.4200 Anaerobic Soil 1,2 Yes 42546403 Yes 5

835.4300 Aerobic Aquatic 1,2 No N/A Yes 6

835.4400 Anaerobic Aquatic 1,2 Yes 44370003, 44370004 Yes 7

Mobility Studies :

835.1230 Leaching – Adsorption/ Desorption 1,2 Yes 42584101, 44370002 In review 8

835.1410 Volatility (Lab) 1,2 Yes Not Available Waived 3

835.8100 Volatility (Field) 1,2 No Not Available Waived 3

Dissipation Studies-Field :

835.6100 Terrestrial Field Dissipation 1,2 Yes 41679601, 41525905, 41525904, 42311401,
42311402 No

835.6200 Aquatic Field Dissipation 1,2 No Not Applicable N/A

835.6300 Forestry Dissipation 1,2 No Not Applicable N/A

Ground Water Monitoring Studies :

835.7100 Ground Water Monitoring 1,2 No NA Reserved

49Table 7.1. Summary of Environmental Fate Data Requirements for Fenpropathrin

Must Additional
Data Be Submitted Does EPA Have

Study Identification Use Under FIFRA Data To Satisfy Pattern 1 Bibliographic Citation 3(c)(2)(B)? This Requirement?

§158.1100 SPRAY DRIFT

201-1 Droplet Size Spectrum 1,2 Yes 40024621 No 9

202-1 Drift Field Evaluation 1,2 No Not Available No 10

Other Studies :

Environmental Chemistry Methods (ECMs) and Independent Laboratory Validations (ILVs) 1,2 Partially 71368 & 100138, 126817, 126818, 41673103, 43958802, 43958803, 47053001,
47053002 In review 9

1. Use Patterns: 1=Terrestrial/Food; 2=Terrestrial/Feed. 2. The available study was performed in the presence of ar ound 8% acetonitrile. A new study is required to clarify uncertainties related to the rate of the proc ess and the possible transformation products. 3. Waived, based on the low vapor pressure and Henry’s Law Constant for fenpropathrin. 4. High variability in the results from the st udy conducted earlier (with shorter half-lives) vs. the most recent study brings uncertainty to the environmental fate assessment. The registrant should submit a study conducted in three additional soils; a sandy loam soil should be included. 5. The available study was performed with only one soil and for a period of only 2 months of anaerobic incubation. Data performed for a longer period of time will help the Agency to determine rates of transfor mation and presence of possible metabolites. Three additional soils are also requi red, for rate of transformation determination. 6. No study has been submitted. The study is required.
7. Two studies are availa ble, performed in only one soil type (yielding half-lives of 78 and 67 days in a CA L). These studies are currently in review. A study conducted in one additional sediment type is required. 8. There are available studies currently in review. The data requirement is considered unfulfilled until the study (studies) is (are) reviewed and deemed acceptable. 9. Data requirement covered by submission of the Spray Drift Task Force.

507.9.2 Effects

For registration review, the follo wing studies are being requeste d to fulfill any data gaps:

Guideline Number: Non-Guideline Study Title: Endocrine Disruptor Screening Program As required under FFDCA section 408(p), EP A has developed the Endocrine Disruptor Screening Program (EDSP) to determine whet her certain substances (including pesticide active and other ingredients) may have an effect in humans or wildlife similar to an effect produced by a “naturally occurring estrogen, or other such endocrine effects as the Administrator may designate.” The EDSP em ploys a two-tiered approach to making the statutorily required determinations. Tier 1 cons ists of a battery of 11 screening assays to identify the potential of a chemical substan ce to interact with th e estrogen, androgen, or thyroid (E, A, or T) hormona l systems. Chemicals that go through Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA will determine which, if any, of the Tier 2 tests are necessary based on the available data. Ti er 2 testing is designed to identify any adverse endocrine related effects caused by th e substance, and esta blish a dose-response relationship between the dose a nd the E, A, or T effect.

Between October 2009 and February 2010, EPA issu ed test orders/data call-ins for the first group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. This list of chemicals was selected based on the potential for human exposure through pathways such as food and wa ter, residential activity, and certain postapplication agricultural s cenarios. This list should not be construed as a list of known or likely endocrine disruptors.

Fenpropathrin is not among the group of 58 pestic ide active ingredients on the initial list
to be screened under the EDSP. Under FFDCA sec. 408(p) the Agency must screen all pesticide chemicals. Accordingly, EPA anticip ates issuing future EDSP test orders/data call-ins for all pesticide active ingredients.

For further information on the status of the ED SP, the policies and procedures, the list of 67 chemicals, the test guidelines and the Tier 1 screening battery, please visit our
website: http://www.epa.gov/endo/

.

Guideline Number: 850-2100 Study Title: Passerine Acute Avian Oral Although an acute avian oral study was rece ived for the mallard duck, the Agency updated its data requirements in 40 CFR Part 158 (October 26, 2007) to include an acute oral toxicity study for both a pa sserine species and either a waterfowl or an upland game species. Prior to starting toxicity testing, a pr otocol will need to be provided for review. Many passerine species utili ze agricultural fields, fore sts, residential areas and surrounding areas, and, therefore, have the potential to be exposed to pesticides used in agricultural, forest, and residential settings. It is likely that, for most pesticide use patterns, passerines are more likely to be e xposed to pesticides than upland game species

51and waterfowl. Passerines are smaller and ha ve faster metabolisms than the waterfowl and upland game bird species tr aditionally used in avian toxi city tests which could impact their sensitivity to chemicals.

Guideline Number: 850-1400 Study Title: Fish Early Life Stage (Saltwater) No acceptable chronic studies for fenpropathrin have been submitted for marine fish. The acute toxicity of fenpropathrin to estuarine/marine fish a nd environmental fate properties indicates the potential for ch ronic exposure and effects to animals in this taxon, per 40 CFR Part 158 data requirements (October 26, 2007). For example, the acute LC 50 for freshwater fish (2.2 μ g ai/L) is well below the 1.0 mg/L criterion specified in 40 CFR Part 158 for conditionally requiring this st udy. Furthermore, th e persistence of fenpropathrin in water is expected to substa ntially exceed the 4-da y half life criterion. Without this study, the Agency would have to presume chronic risk to listed and nonlisted estuarine/marine fish, but would not be able to quantify the risk.

Guideline Numbers: Non-Guideline Study Title: Whole sediment chronic toxicity: invertebrates freshwater and marine No chronic sediment toxicity tests for fres hwater or marine invertebrates have been submitted to satisfy the Agency’s updated data requirements for outdoor uses in 40 CFR Part 158 (October 26, 2007). For fenpropathri n, available information indicates that benthic organisms may be exposed via run-o ff or spray drift applications used in agricultural, forest, and residential settings . Specifically, the peak sediment porewater EECs predicted for fenpropathrin (0.06 – 0.76 ppb) all exceed 0.1 of the acute LC/EC50 (0.021 ppb for M. bahia ), which satisfies one of the cr iteria for requiring chronic whole sediment toxicity testing under 40 CFR Part 158. Further, the expected half-life of fenpropathrin in sediment (67-78 days for anaer obic aquatic metabolism) is substantially greater than 40 CFR Part 158 crit erion of 10 days. The third set of trigger criteria for requiring chronic testing (K d > 50, or log K OW >3 or K OC > 1000) is also met for fenpropathrin (e.g., K d values are 64-810, log K OW is 6, and K OC values are 13870- 85260). Finally, there the potential for pe rsistent exposure from fenpropathrin in sediment is also indicated by open lite rature studies on pyrethroids (Weston et al. 2005, Amweg et al. 2006 and Ding et al . 2009).

For sediment studies involving pyrethroids, tests on Hyalella azteca

, Chironomus

tentans , and Leptocheirus plumulosus are requested. Although both are freshwater species, Hyalella and Chironomus differ substantially in their ecological niche (i.e., epibenthic vs. infaunal species), physiology, and there is some evidence suggesting Hyalella is among the more sensitive invertebra tes to some pyrethroids based on water column tests (Anderson et al. 2006, Maund et al., 2002). Fenpropathrin has the potential
to enter estuarine/marine water bodies base d on current usuage pa tterns that include coastal areas. Therefore, testing is required for Leptocheirus plumulosus , an estuarine/marine sediment-dwe lling invertebrate species.

52Guideline Numbers: 850.4150 and 850.4250 Study Title: Vegetative vigor and Seedling emergence, Tier I/Tier II No acceptable toxicity data are currently ava ilable to assess the risk of fenpropathrin to non-target terrestrial plants. Since fenpropathrin has reside ntial outdoor uses, vegetative vigor and seedling emergence studies ar e required (40 CFR Part 158). These phytotoxicity data are needed to evaluate the level of pesticide exposure to non-target terrestrial and aquatic plants and to assess the impact of pesticides on endangered and threatened plants.

Guideline Number: 850.4400 Study Title: Aquatic Vascular Plant Growth- Lemna spp. Tier I/Tier II No acceptable studies for fenpropathrin have been submitted for vascular aquatic plants. The Agency has finalized its update to the data requirements in 40 CFR Part 158. In these updated data requirements, which were promulgated on October 26, 2007, vascular plant testing is required for pesticides such as fenpropathrin with outdoor uses.

Guideline Number: 850.5400 Study Title: Algal toxicity test

, Tier I/Tier II No toxicity data are currently available to assess the risk of fenpropathrin to aquatic nonvascular plants. Since fenpr opathrin has residential outdoor uses, Tier I/II aquatic nonvascular plant studies are required (40 CFR Part 158). These phytotoxicity data are
needed to evaluate the level of pesticide exposure to non-target aquatic plants and to assess the impact of pesticides on en dangered and threatened plants.

Guideline Numbers: 850.1010 Study Title: Aquatic Invertebrate Acute Toxicity ( Hyalella )
Available information in the ECOTOX databa se indicates that the freshwater amphipod, Hyalella azteca , is substantially more sensitive to pyrethroids than Daphnia magna , the commonly tested freshwater invertebrate. Information on the acute toxicity of fenpropathrin to H. azteca was not identified in this probl em formulation. Therefore, in order to ensure that risk to sensitive aqua tic invertebrates are appropriately quantified, additional acute toxicity testing of H. azteca is needed (water column exposure, not sediment-spiked)

.

53Table 7.2 lists the status of the ecological eff ects data requirements for fenpropathrin.

Table 7.2. Ecological Effects Data Requirements for Fenpropathrin

Data Requirement Use
Pattern Does EPA Have Data To Satisfy
This Requirement?

(Yes, No, or

Partially) Bibliographic
Citation Must
Additional

Data Be
Submitted
Under FIFRA

3(c)(2)(B)?

§158.490 TERRESTRIAL ORGANISMS

71-1(a) Acute Avian Oral, Duck 1,2 Partially 249939 Yes 1

71-2(a) Acute Avian Diet, Quail 1,2 Yes 249939 No

71-2(b) Acute Avian Diet, Duck 1,2 Yes 249939 No

71-3 Wild Mammal Toxicity 1,2 N/A

71-4(a) Avian Reproduction Quail 1,2 Yes 425140-04, 265374 No

71-4(b) Avian Reproduction Duck 1,2 Yes 265373 No

71-5(a) Simulated Terrestrial Field Study 1,2 N/A

71-5(b) Actual Terrestrial Field Study 1,2 N/A

§158.630 AQUATIC ORGANISMS TESTING

72-1(a) Acute Fish Toxicity Bluegill

Acute Fish Toxicity Catfish 1,2

1,2 Yes

Yes 249939

249939 No

No

72-1(b) Acute Fish Toxicity (TEP) * 1,2 Yes 250159 No

72-1(c) Acute Fish Toxicity Rainbow

Trout 1,2 Yes 249939 No

72-2(a) Acute Aquatic Invertebrate 1,2 Yes 249939 No

72-2(b) Acute Aquatic Invertebrate (TEP) * 1,2 Yes 250159 No

72-3(a) Acute Est/Mar Toxicity Fish 1,2 Yes 249939 No

72-3(b) Acute Est/Mar Toxicity Mollusk 1,2 Yes 409744-05 No

72-3(c) Acute Est/Mar Toxicity Shrimp 1,2 Yes 409744-04 No

72-3(d) Acute Est/Mar Toxicity Fish (TEP)* 1,2 Yes 409744-06 No

72-3(e) Acute Est/Mar Toxicity Mollusk (TEP) 1,2 Yes 412952-01 No

72-3(f) Acute Est/Mar Toxicity Shrimp (TEP) 1,2 Yes 409744-05 No

54Table 7.2. Ecological Effects Data Requirements for Fenpropathrin

Does EPA Have Must

Data Requirement Use
Pattern Data To Satisfy Additional
This Data Be Requirement? Submitted

(Yes, No, or

Partially) Bibliographic Under FIFRA
Citation 3(c)(2)(B)?

72-4(a) Early Life Stage Fish 1,2 Yes (freshwater)

No (saltwater) 415259-01

N/A No

Yes

72-4(b) Life Cycle Aquatic Invertebrate (freshwater) 1,2 Yes 259678 No

850.1350 Life Cycle Aquatic Invertebrate (saltwater) 1,2 Yes 409744-07 No

72-5 Life Cycle Fish 1,2 N/A N/A No

72-6 Aquatic Organism Accumulation 1,2 NA

72-7(1) Simulated Aquatic Field Study 1,2 NA

72-7(b) Actual Aquatic Field Study 1,2 NA

850.1730 Bioaccumulation in Fish 1,2 Yes 00153802, 00161672, 00161673, 00163521 No

850.1950 Accumulation in Aquatic Nontarget Organisms 1,2 No NA No

850.1010 Aquatic Invertebrate Acute Toxicity ( Hyalella azteca ) 1, 2 No NA Yes

850.1735 Whole sedimen t: acute freshwater
invertebrates 1, 2 Yes 470838-01 No

850.1740 Whole sediment: acute marine
invertebrates 1, 2 No NA Held in reserve

Whole sediment: chronic invertebrates
freshwater (Hyalella azteca ) 1, 2 No NA Yes

Whole sediment: chronic invertebrates
freshwater (Chironomus dilutus ) 1, 2 No NA Yes

Whole sediment: chronic invertebrates freshwater & marine ( L. plumulosus ) 1, 2 No NA Yes

§158.540 PLANT PROTECTION

122-1(a) Seed Germ, Seedling Emergence 1,2 No NA Yes

122-2 Aquatic Plant Growth 1,2 No NA Yes

122-1(b) Vegetative Vigor 1,2 No NA Yes

123-1(a) Seed Germ./Seedling Emerg. 1,2 NA NA No 2

55Table 7.2. Ecological Effects Data Requirements for Fenpropathrin

Does EPA Have Must

Data Requirement Use
Pattern Data To Satisfy Additional
This Data Be Requirement? Submitted

(Yes, No, or

Partially) Bibliographic Under FIFRA
Citation 3(c)(2)(B)?

123-1(b) Vegetative Vigor 1,2 NA NA No 2

123-2 Aquatic Plant Growth 1,2 NA NA No 3

124-1 Terrestrial Field Study 1,2 NA

124-2 Aquatic Field Study 1,2 NA

§158.490 NONTARGET INSECT TESTING

141-1 Honey Bee Acute Contact 1,2 Yes Atkins 1984 No

141-2 Honey Bee Residue on Foliage (TEP) 1,2 Yes 133103 No

141-5 Field Test for Pollinators 1,2 NA

1 Data are required for one passerine species and either on waterfowl or one upland ga me bird species. At this time, only an acute oral test for a waterfowl species has been submitted.

2 Required if a tested terrestrial species exhibits a 25 pe rcent or greater detrimental e ffect in the Tier I study.

3 Required if a tested aquatic species exhibits a 50 per cent or greater detrimental e ffect in a Tier I study.

*Note: No further aquatic toxicity formul ation (TEP) testing is required because sufficient data has been submitted and no outdoor use formulations contain known synergists.

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619. Bibliography



### 161-1 Hydrolysis

MRID Citation Reference

131438 Takahashi, N.; Mikami, N.; Yamada, H.; et al. (1983) Hydrolysis of Fenpropathrin in Aqueous Media: Doc. Code FM-30-0010. (Unpublished study received Oct 3, 1983 under 39398-16; prepared by Sumitomo Chemical Co., Ltd., Japan, submitted by Sumitomo Chemical America, Inc., New York, NY; CDL:251415-B)
141320 Takahashi, N.; Mikami, N. (1984) The Response to EPA's Requirement Concerning Hydrolysis Studies of Fenpropathrin in aqueous Media. Ref. No. FM-30-0010. Unpublished study prepared by Sumitomo Chemical Co., Ltd. 32 p.
42599901 Concha, M.; Shepler, K.; Ruzo, L. (1992) Hydrolysis of (Carbon 14- acid) and (Carbon 14-alcohol) Fenpropathrin at pH 5, 7 and 9: Lab Project Number: 334W. Unpublished study prepared by PTRL-West, Inc. 130 p. 

### 161-2 Photodegradation-water

MRID Citation Reference

42546401 Jalai-Araghi, K.; Ruzo, L.; Shepler, K. (1992) Photodegradation of carbon 14|-acid and carbon 14|-alcohol Fenpropathrin in a Buffered Aqueous Solution at pH 5 by Natural Sunlight: Lab Project Number: 336W-1: 336W. Unpublished study prepared by PTRL-West, Inc. 103 p.
137769 Takahashi, N.; Mikami, N.; Yamada, H.; et al. (1983) Photodegradation of Fenpropathrin in Water, and on Soil and Plant Foliage: Doc. Code Fm-30; Ref. No. -0011. (Unpublished study received Jan 15, 1984 under 39398- 17; prepared by Sumitomo Chemical Co., Ltd., Japan, submitted by Sumitomo Chemical America, Inc., New York, NY; CDL:252780-B) 

### 161-3 Photodegradation-soil

MRID Citation Reference

137769 Takahashi, N.; Mikami, N.; Yamada, H.; et al. (1983) Photodegradation of Fenpropathrin in Water, and on Soil and Plant Foliage: Doc. Code Fm-30; Ref. No. -0011. (Unpublished study received Jan 15, 1984 under 39398- 17; prepared by Sumitomo Chemical Co., Ltd., Japan, submitted by Sumitomo Chemical America, Inc., New York, NY; CDL:252780-B)
42546402 Concha, M.; Ruzo, L.; Shepler, K. (1992) Photodegradation of carbon 14|- acid and carbon 14|-alcohol Fenpropathrin in/on Soil by Natural Sunlight: Lab Project Number: P344W-1: P344W . Unpublished study prepared by PTRL-West, Inc. 117 p.


### 162-1 Aerobic soil metabolism

MRID Citation Reference

126821 or
130867 Noble, A.; Loveridge, D. (1976) Soil Percolation and Aqueous Die- away Studies with WL 41706: Group Research Report WKGR.0127.76. (Unpublished study received Apr 8, 1983 under 39398-16; prepared by Shell Research Ltd., Eng., submitted by Sumitomo Chemical American, Inc., New York, NY; CDL:249936-F)

62126822 Roberts, T.; Standen, M.; Dutton, A. (1976) The Degradation of the Insecticide WL 41706 in Soil under Laboratory Conditions: Group Research Report WKGR.0061.76; Doc. Code FR-61-0014. (Unpublished study received Apr 8, 1983 under 393 98-16; prepared by Shell Research Ltd., Eng., submitted by Sumitomo Chemical America, Inc., New York, NY; CDL:249936-G)
126823 Mikami, N.; Sakata, S.; Yamada, H.; et al. (1983) Degradation of Fenpropathrin in Soil: Doc. Code FM-30-0008. (Unpublished study received Apr 8, 1983 under 39398-16; prepared by Sumitomo Chemical Co., Ltd., Japan, submitted by Sumi tomo Chemical America, Inc., New York, NY; CDL:249936-H)
129015 Roberts, T.; Standen, M. (1977) Degrad ation of the pyrethroid insecticide WL 41706 (~+?)-alpha-cyano-3-phenoxybenz yl 2,2,3,3- tetramethylcyclopropanecarboxylate, in soils. Pestic. Sci. 8: 600-610

. (Also In unpublished submission received Jun 8, 1983 under 20954-EX-19; submitted by Zoecon Corp., Palo Alto, CA; CDL:250536-B)
130868 Roberts, T.; Standen, M.; Dutton, A. (1980) The Degradation of the Insecticide WL 41706 in Soil under Laboratory Conditions: WKGR.0061.76. (Unpublished study received Sep 21, 1983 under 39398- 16; prepared by Shell Research, Lt d., Eng., submitted by Sumitomo Chemical America, Inc., New York, NY: CDL:251317-F)
130869 Mikami, N.; Sakata, S.; Yamada, H.; et al. (1983) Degradation of Fenpropathrin in Soil: Doc. Code FM-30. (Unpublished study received Sep 21, 1983 under 39398-16; prepared by Sumitomo Chemical Co., Ltd., Japan, submitted by Sumitomo Chemical America, Inc., New York, NY; CDL:251317-G)
142547 Mikami, N; Sakata, S.; Yamada, H. (1984) The Re sponse to EPA's Requirement Concerning Soil Studies of Fenpropathrin (Danitol): Data on Degradation in Soils under Aerobic Conditions at Shorter Time Points: FM-40-0014 Unpublished study prepared by Sumitomo Chemical Co., LTD. 5 p.
41525902 Cranor, W. (1990) Aerobic Soil Metabolism of Benzyl-(Carbon 14)|-- Fenpropathrin: Lab Project I.D.: 34586. Unpublished study pre- pared by Analytical Bio-Chemistry Laboratories, Inc. 98 p.


### 162-2 Anaerobic soil metabolism

MRID Citation Reference

42546403 Daly, D.; Williams, M. (1990) Anaerobic Soil Metabolism of carbon 14|- Fenpropathrin: Lab Project Number: 38182. Unpublished study prepared by Analytical Bio-Chemistry Labs, Inc. 687 p. 

### 162-3 Anaerobic aquatic metab.

MRID Citation Reference

126821 Noble, A.; Loveridge, D. (1976) Soil Percolation and Aqueous Die- away Studies with WL 41706: Group Research Report WKGR.0127.76. (Unpublished study received Apr 8, 1983 under 39398-16; prepared by Shell Research Ltd., Eng., submitted by Sumitomo Chemical American, Inc., New York, NY; CDL:249936-F)
44370003 Kaman, R. (1995) An Anaerobic Aquatic Soil Metabolism Study with (Phenoxyphenyl-(carbon 14))-Fenpropathrin: Lab Project Number: 92-0010: 5164-92-0010-EF-001: 5164-92-0010-EF-000. Unpublished study prepared by Ricerca, Inc. 191 p.
44370004 Kaman, R. (1994) An Anaerobic Aquatic Soil Metabolism Study with

63(Cyclopropyl-1-(carbon 14))-Fenpropa thrin: Lab Project Number: 92-0011: 5164-92-0011-EF-002: 5164-92-0011-EF-000. Unpublished study prepared by Ricerca, Inc. 232 p. 

### 163-1 Leach/adsorp/desorption

MRID Citation Reference

126819 Roberts, T.; Hitchings, E.; Jackson, C. (1976) The Leaching Behaviour of WL 41706 in Laboratory Soil Columns: Group Research Re- port WKGR.0070.76; Doc. Code FR-61-0012. (Unpublished study received Apr 8, 1983 under 39398-16; prepared by Shell Research Ltd., Eng. submitted by Sumitomo Chemical America, Inc., New York, NY; CDL:249936-D)
126820 Mikami, N.; Yoshimura, J.; Yamada, H.; et al. (1983) Leaching Behaviour of Fenpropathrin in Soil: Doc. Code FM-30-0007. (Unpublished study received Apr 8, 1983 under 39398-16; prepared by Sumitomo Chemical Co., Ltd., Japan, submitted by Sumitomo Chemi- cal America, Inc., New York, NY; CDL:249936-E)
126821 or
130867 Noble, A.; Loveridge, D. (1976) Soil Percolation and Aqueous Die- away Studies with WL 41706: Group Research Report WKGR.0127.76. (Unpublished study received Apr 8, 198 3 under 39398-16; prepared by Shell Research Ltd., Eng., submitted by Sumitomo Chemical American, Inc., New York, NY; CDL:249936-F)
130866 Roberts, T.; Hitchings, E.; Jackson, C.; et al. (1980) The Leadhing Behavior of WL 41706 in Laboratory Soil Columns: WKGR.0070.76. (Unpublished study received Sep 21, 1983 under 3 9398-16; prepared by Shell Research Ltd., Eng., submitted by Sumitomo Chemical America, Inc., New York, NY; CDL:251317-C)
42584101 Lee, D. (1992) Adsorption and Desorption of Fenpropathrin to Soils: Lab Project Number: 5057-91-0317-EF-001. Unpublished study prepared by Ricerca, Inc. 108 p.
44370002 Shelby, D. (1996) Report Amendment to: Adsorption and Desorption of Fenpropathrin to Soils MRID #42584101: Lab Project Number: 5057-91- 0317-EF-001-001: 91-0317. Unpublished study prepared by Ricerca, Inc. 89

p. 

### 164-1 Terrestrial field dissipation

MRID Citation Reference

151204 Fujie, G. (1985) Fenpropathrin Dissipation in Citrus Orchard Soil. Unpublished study prepared by Chevron Chemical Co. 32 p.
163828 Fujie, G.; Leary, J.; Abell, J. (1985) Fenpropathrin Dissipation in Citrus Orchard Soil. Unpublished study prepared by Chevron Chemical Co. 35 p.
163829 Fujie, G.; Leary, J.; Abell, J. (1986) Field Dissipation of Fenpropathrin in Michigan, Mississippi, and New York Soils. Unpublished study prepared by Chevron Chemical Co. 204 p.
41525904 Fujie, G. (1990) Field Dissipation Study with Fenpropathrin on Grapes in California: Lab Project I.D.: 1641-88-7 209. Unpublished study prepared by Chevron Chemical Co., Agricultural Chemical Div. 481 p.
41525905 Fujie, G. (1990) Field Dissipation Study with Fenpropathrin on Apples in New York: Lab Project I.D.: 1641-88-7208. Unpublished study prepared by Chevron Chemical Co., Agricultural Chemicals Div. 342 p.
41679601 Fujie, G. (1990) Field Dissipation Study with Fenpropathrin on Apples in Washington: Lab Project Number: 1641/88/7207. Un- published study prepared by Chevron Chemical Co. 455 p.
42311401 Fujie, G. (1992) Field Dissipation Study with Fenpropathrin on Cotton in

64Mississippi: Lab Project Number: 1641/89/7341. Unpublished study prepared by Chevron Chemical Co. 587 p.
42311402 Fujie, G. (1991) Field Dissipation Study with Fenproppathrin on Bare Ground in California: Lab Project Number: 1641/89/7340. Unpublished study prepared by Chevron Chemical Co. 411 p.
42311403 Fujie, G. (1992) Discussion on Dississipation of Fenpropathrin in Soil Under Field Conditions: Lab Project Num ber: 1641/10435. Unpublished study prepared by Chevron Chemical Co. 13 p. Dissipation on vineyard soils, citrus orchard soils


### 165-4 Bioaccumulation in fish

MRID Citation Reference

153802 Forbis, A.; Shaffer, S. (1985) Uptake, Depuration and Bioconcentration of [Cyclopropyl-1-(Carbon-14)] and [Benzyl -1-(Carbon-14)] Fenpropathrin by Bluegill Sunfish (Lepomis macrochirus): ABC Final Report #32007. Unpublished study prepared by Analytical Bio-Chemistry Laboratories, Inc. 65

p. 161672 Forbis, A.; Shaffer, S. (1986) Uptake, Depuration and Bioconcentra- tion of [Cyclopropyl-1-[carbon 14]] and [Benzyl-1-[carbon 14]] Fenpropathrin by Bluegill Sunfish (Lepomis macrochirus): ABC Final Report # 32007 : [Includes Comments of Sumitomo Chemical Co. and Revised Residue Data by Chevron Chemical Co.]. Unpub- lished study pr epared by Analytical Bio-Chemistry Laboratories, Inc. 72 p.
161673 Takimoto, Y.; Ohshima, M.; Matsuda, T.; et al (1985) Accumulation and Metabolism of [Benzyl-1-[carbon 14]]-fenpropathrin in Carp (Cyprinus carpio). Unpublished study prepared by Sumitomo Chemical Ltd., Laboratory of Biochemistry and Toxicology. 20 p.
163521 Cheng, H. (1986) Characterization of [Carbon 14] Residues in Blue- gill Sunfish Treated with [Carbon 14]-Fenpropathrin (Revised). Unpublished study prepared by Chevron Chemical Co. 15 p. 

### 201-1 Droplet size spectrum

MRID Citation Reference

40024621 Akesson, N. (1986) Danitol 2.4 EC Spray Drift Determination Droplet Size Spectrum Study: Laboratory Project Iden tification 8613397. Unpublished study prepared by Univ. of California, Davis. 35 p.



### Non Guideline Selections

71368 Shell Development Company (1975) Determination of Individual or Combined Residues of the Cyano Pyrethroids on Soil: GLC-Alkali Flame Ionization Detector. Method MMS-R-425-1 dated Ap r 1975. (Unpublished study received Feb 1, 1976 under 6G1755; CDL: 099958-I)
97456 Tu, C.M. (1980) Influence of five pyrethroid insecticides on microbial populations and activities in soil. Microbial Ecology 5:321-327

. (Also In unpublished submission received Mar 17, 1982 under 59-200; submitted by Burroughs Wellcome Co., Research Triangle Park, N.C.; CDL:247048-D)
100138 Shell Development Co. (1975) Determination of Individual or Combined Residues of the Cyano Pyrethroids on Soil: GLC-alkal: Flame Ionization Detector: MMS-R-425-1. (Unpublished study re- ceived May 9, 1978 under 201- 401; CDL:097083-L)
126817 Akutu, S.; Matsuo, M.; Miyamoto, J. (1980) Method of Analysis of S- 3206 in Water: Doc. Code FA-00-0008. (Unpublished study re- ceived Apr 8, 1983 under

6539398-16; prepared by Sumitomo Chemic al Co., Ltd., Japan, submitted by Sumitomo Chemical America, Inc., New York, NY; CDL:249936-B)
126818 Shell Research Ltd. (19??) Determinat ion of Residues of WL 41706 in Soil: WAMS 228-1. (Unpublished study received Apr 8, 1983 under 39398-16; submitted by Sumitomo Chemical Amer ica, Inc., New York, NY; CDL:249936-C)
126824 Miyamoto, J. (1980) Comments on the Metabolic Fate of 3-Phenoxybenzoic Acid and 2,2,3,3-Tetramethylcyclopropanecarboxy lic Acid in the Soil: Doc. Code FM00-0006. (Unpublished study received Apr 8, 1983 under 39398-16; prepared by Sumitomo Chemical Co., Ltd., Japan, submitted by Sumitomo Chemical America, Inc., New York, NY; CDL:249936-I)
130870 Miyamoto, J. (19??) Comments on the Metabolic Fate of 3-Phenoxybenzoic Acid and 2,2,3,3-Tetramethylcyclopropanecarboxy lic Acid in Soil. (Unpublished study received Sep 21, 1983 under 39398-16; submitted by Sumitomo Chemical America, Inc., New York, NY; CDL: 251317-H)
43958802 Wiens, A. (1995) Independent Lab Valid ation of the Methods for Quantitation of Fenproprathrin (sic) in Hydrosoil and Pond Water: Lab Project Number: 1466-B: 1466-B-1: RM-22S-5. Unpublished study prepared by Analytical Development Corp. 115 p.
43958803 Wiens, A. (1995) Independent Lab Valid ation of the Method for Quantitation of Fenproprathrin (sic) in Soil: Lab Project Number: 1466-A: 1466-A-1: RM-22S-4. Unpublished study prepared by Analytical Development Corp. 57 p.
126816 Sumitomo Chemical America, Inc. (1983) Physico-chemical Proper- ties, Stability, Decomposition Rate in Alkaline Solution, Active Ingredient, Manufacturing Process, GLC Determination and Analytical Method for the Determination of Impurities: S-3206|. (C ompilation; unpublished study received Apr 8, 1983 under 39398-16; CDL:249936-A)
130865 Sumitomo Chemical America, Inc. (1983 ) Physico-chemical Properties of S-3206 T.G. (Compilation; unpublished study received Sep 21, 1983 under 39398-16; CDL:251317-A)
131437 Sumitomo Chemical Co., Ltd. (1983) Pa rtition Coefficient (n-Octanol/Water) of Fenpropathrin: Doc. Code FP-30-0016. (Unpublished study received Oct 3, 1983 under 39398-16; submitted by Sumitomo C hemical America, Inc., New York, NY; CDL:251415-A)
137768 Mikami, N.; Miyamoto, J. (1983) The Response to EPA's Requirement Concerning Soil Studies of Fenpropathrin (Danitol): Data on the Half-life and Kd Calculations, and 0.33 Bar Soil Moisture: Doc. Code FM-30; Ref. No. -0013. (Unpublished study received Jan 15, 1984 under 39398-17; prepared by Sumitomo Chemical Co., Ltd., Japan, submitted by Sumitomo Chemical America, Inc., New York, NY; CDL:252780-A)



### 71-1 Avian Singl e Dose Oral Toxicity

MRID Citation Reference

127370 Fink, R. (1975) Acute Oral LD50: Mallard Ducks: SD 41706: Project No. 109- 110; Doc. Code FW-51-0003. Final rep t. (Unpublished study received Apr 8, 1983 under 39398-16; prepared by Truslow Farms, Inc., submitted by Sumitomo Chemical America, Inc., New York, NY; CDL:249939-D)



### 71-2 Avia n Dietary Toxicity

MRID Citation Reference

127371 Fink, R. (1975) Eight-day Dietary LC50: Mallard Ducks: SD 41706: Project No.

66109-109; Doc. Code FW-51-0001. Final rep t. (Un- published study received Apr 8, 1983 under 39398-16; prepared by Tr uslow Farms, Inc., submitted by Sumitomo Chemical America, Inc., New York, NY; CDL:249939-E)
127787 Fink, R. (1975) Eight-day Dietary LD 50: Bobwhite Quail: SD 41706: Project No. 109-108; Doc. Code FW-51-0002. Final rep t. (Un- published study received Apr 8, 1983 under 39398-16; prepared by Tr uslow Farms, Inc., submitted by Sumitomo Chemical America, Inc., New York, NY; CDL:249939-F) 

### 71-4 Avian Reproduction

MRID Citation Reference

127788 Fink, R. (1975) One-generation Reproduction Study: Mallard Duck: SD 41706: Project No. 109-116; FW-51-0004. Final rept. (Un- published study received Apr 8, 1983 under 39398-16; prepared by Truslow Farms, Inc., submitted by Sumitomo Chemical America, Inc., New York, NY; CDL:249939-G)
127789 Fink, R. (1975) One-generation Reproduction Study: Bobwhite Quail: SD 41706: Project No. 109-115; FW-51-0005. Final rept. (Unpublished study received Apr 8, 1983 under 39398-16; pr epared by Truslow Farms, Inc., submitted by Sumitomo Chemical America, Inc., New York, NY; CDL:249939- H)
163810 Beavers, J. (1986) Fenp ropathrin Technical: A One-generation Reproduction Study with the Mallard (Anas platyrhyrc hos) Final Report: Laboratory Project Id. 162-158. Unpublished study prepared by Wildlife International Ltd. in cooperation with Chevron Chemical Co. 121 p.
163811 Beavers, J. (1986) Fenp ropathrin Technical: A One-generation Re- production Study with the Bobwhite (Colinus Virgin ianus) Final Report: Laboratory Project Id. 162-157. Unpublished study prepared by Wildlife International Ltd. in cooperation with Chevron Chemical Co. 140 p.
42514001 Beavers, J.; Lattin, A.; Smith, G. et al. (1990) Fenpropathrin: A One-generation Reproduction Study with the Northern B obwhite (Colinus virginianus) Danitol 2.4 EC Spray|: Lab Project Number: 203 -102. Unpublished study prepared by Wildlife Int'l Ltd. 110 p. 

### 71-5 Simulated or Actual Field Testing

MRID Citation Reference

42514002 Johnson, G.; Krueger, H.; Jaber, M. (1987) Danitol 2. 4 EC Spray: A Residue Monitoring Study in Apple Orchards in the Hudson River Valley of New York State to Assess Exposure to Avian S pecies under Standard Agricultural Use Conditions: Lab Project Number: 162-178. Unpublished study prepared by Wildlife Int'l Ltd. 105 p.
42514003 Johnson, G.; Krueger, H.; Jaber, M. (1987) Danitol 2. 4 EC Spray: A Residue Monitoring Study in Apple Orchards in the Yakima Valley of Washington State to Assess Exposure to Avian Specie s under Standard Agricultural Use Conditions: Lab Project Number: 162-179. Unpublished study prepared by Wildlife Int'l Ltd. 93 p.

67

### 72-1 Acute Toxicity to Freshwater Fish

MRID Citation Reference

71642 Shell Chemical Company (1975) Toxicity of the Pyrethroid Insecticides, SD 43775 and SD 41706, to Fish. (Unpublished study received Apr 9, 1981 under 6G1755; CDL:099983-S)
74131 Shell Chemical Company (1975) Toxicity of the Pyrethroid Insecticides, SD 43775 and SD 41706, to Fish. (Compilation; unpublished study received Jan 15, 1979 under 201-401; CDL:099947-E)
100108 Shell Oil Co. (1975) SD 43775: Toxicity in Fish|. (Compilation; unpublished study received Jan 15, 1979 under 201-401; CDL: 097755-C)
109833 Shell Chemical Co. (1975) Toxicity of the Pyrethroid Insecticides, SD 43775 and SD 41706, to Fish. (Compilation; unpublished study received Mar 8, 1976 under 201-EX-50; CDL:095407-P)
121829 Shell Chemical Co. (1975) Toxicity of SD 43775 and SD 41706 to Fish|. (Compilation; unpublished study received Oct 6, 1977 under 201-401; CDL:096385-Y)
127790 LeBlanc, G.; Sousa, J. (1981) Acute Toxicity of S-3206 TG to Rainbow Trout (Salmo gairdneri): Report #BW-81-8-987; Doc. Code FW- 11-0017. (Unpublished study received Apr 8, 198 3 under 39398- 16; prepared by EG & G, Bionomics, submitted by Sumitomo C hemical America, Inc., New York, NY; CDL:249939-I)
127791 LeBlanc, G.; Sousa, J. (1981) Acute Toxicity of S-3206 TG to Bluegill (Lepomis macrochirus): Report #BW-81-8-988; Doc. Code FW- 11-0020. (Unpublished study received Apr 8, 1983 under 39398- 16; prepared by EG & G, Bionomics, submitted by Sumitomo Chemi- cal Am erica, Inc., New Yo rk, NY; CDL:249939- J)
127792 LeBlanc, G.; Sousa, J. (1981) Acute Toxicity of S-3206 TG to Channel Catfish (Ictalurus punctatus): Report #B W-81-8-989; Doc. Code FW-11-0018. (Unpublished study received Apr 8, 1983 under 39398-16; prepared by EG & G, Bionomics, submitted by Sumitomo C hemical America, Inc., New York, NY; CDL:249939-K)
128349 LeBlanc, G.; Sousa, J. (1981) Acute Toxicity of S-3206 2.4 Lb/G EC to Bluegill ...: Report #BW-81-8-9 85; Doc. Code FW-11- 0019. (Unpublished study received May 11, 1983 under 39398-16; pre- pared by EG & G, Bionomics, submitted by Sumitomo Chemical Amer ica, Inc., New York, NY; CDL:250159-L)
128350 LeBlanc, G.; Sousa, J. (1981) Acute Toxicity of S-3206 2.4 Lb/G EC to Channel Catfish .Report #BW-81-8- 979; Doc. Code FW-11- 0022. (Unpublished study received May 11, 1983 under 39398-16; prepared by EG & G, Bionomics, submitted by Sumitomo Chemical America, Inc., New York, NY; CDL:250159- M)
128471 LeBlanc, G.; Sousa, J. (1981) Acute Toxicity of S-3206 2.4 Lb/G EC to Rainbow Trout . Report #BW-81-8-984; Doc. Code FW-11-0021. (Unpublished study received May 11, 1983 under 39398-16; pre- pared by EG & G, Bionomics, submitted by Sumitomo Chemical America, Inc., New York, NY; CDL:250159-K)
41068002 Coats, J.; O'Donnell-Jeffery, N. (1979) Toxicity of four synthetic pyrethroid insecticides to rainbow trout. Bulletin of Environmental Contamination and Toxicology 23:250-255.

68

### 72-2 Acute Toxicity to Freshwater Invertebrates

MRID Citation Reference

127795 LeBlanc, G.; Surprenant, D. (1981) Acute Toxicity of S-3206 TG to the Water Flea (Daphnia magna): Report #BW-81-8-996; Doc. Code FW-11-0015. (Unpublished study received Apr 18, 1983 under 39398-16; prepared by EG & G, Bionomics, submitted by Sumitomo C hemical America, Inc., New York, NY; CDL:249939-N)
128472 LeBlanc, G.; Surprenant, D. (1981) Acute Toxicity of S-3206 2.4 Lb/ G EC to the Water Flea ...: Report #BW-81-8-997; Doc. Code FW- 11-0016. (Unpublished study received May 11, 1983 under 39398- 16; prepared by EG & G, Bionomics, submitted by Sumitomo C hemical America, Inc., New York, NY; CDL:250159-N) 

### 72-3 Acute Toxicity to Estuarine/Marine Organisms

MRID Citation Reference

127793 Ward, G. (1981) Acute Toxicity of S-3206 T.G. to Sheepshead Minnows (Cyprinodon variegatus): Report No. BP -81-7-114; Doc. Code FW- 11-0013. (Unpublished study received Apr 8, 198 3 under 39398- 16; prepared by EG & G Bionomics, submitted by Sumitomo Chemical America, Inc., New York, NY; CDL:249939-L)
127796 Ward, G. (1981) Acute Toxicity of S-3206 T.G. to Pink Shrimp (Penaeus duorarum): Report No. BP-81-7-124; Do c. Code FW-11-0012. (Unpublished study received Apr 8, 1983 under 393 98-16; prepared by EG & G Bionomics, submitted by Sumitomo Chemical America, Inc., New York, NY; CDL:249949- O)
127797 Ward, G. (1981) Acute Toxicity of S-3206 T.G. to Fiddler Crabs (Uca pugilator): Report No: BP-81-7-112; Doc. Code FW-11-0014. (Un- published study received Apr 8, 1983 under 39398-16; prepared by EG & G Bionomics, submitted by Sumitomo Chemical America, Inc., New York, NY; CDL:249939- P)
40974403 Dionne, E. (1988) Acute Toxicity of Danitol Technical to Eastern Oysters (Crassostrea virginica): Study # 981.0287.6119.504; Rept. #87-9-2465. Unpublished study prepared by Springborn Life Sciences, Inc. 54 p.
40974404 Hoberg, J. (1987) Acute Toxicity of Carbon 14|-Danitol Technical to Mysid Shrimp (Mysidopsis bahia): Study #981.0287.6117.510; Rept. #87-8-2470. Unpublished study prepared by Springborn Life Sciences, Inc. 53 p.
40974405 Hoberg, J. (1987) Acute Toxicity of Danitol 2.4 EC to Mysid Shrimp (Mysidopsis bahia): Study #981.0287.6116.510: Re pt. #87-7-2522. Unpublished study prepared by Springborn Life Sciences, Inc. 48 p.
40974406 Nicholson, R. (1987) Acute Toxicity of Danitol 2.4 EC to Sheepshead Minnow (Cyprinodon variegatus): Study #981.0287.6115.500; Rept. # 87-7-2447. Unpublished study prepared by Springborn Life Sciences, Inc. 45 p.
41295201 Dionne, E. (1988) Acute Toxicity of Danitol 2.4 EC to Eastern Oysters (Crassostrea virginica) under Flow-t hrough Conditions: Lab Project Number: 981-0278-6118-504. Unpublished study pr epared by Chevron Chemical Co. 63

p.

69

### 72-4 Fish Early Life Stag e/Aquatic Invertebrate Life Cycle Study

MRID Citation Reference

153801 Forbis, A.; Burgess, D.; Bunch, B. ( 1985) Chronic Toxicity of [Cyclopropyl-1- (Carbon-14)] Fenpropathrin to Daphnia magna under Flow-through Test Conditions: Final Report #32547. Unpubl ished study prepared by Analytical Bio-Chemistry Laboratories, Inc. 26 P.
40974407 Hoberg, J.; Surprenant, D. (1988) Chronic Toxicity of Carbon 14|- Danitol Technical to Mysid Shrimp (Mysidopsis bahia): Study # 981.0287.6120.530; Rept. #87-11-2544. Unpublished study pre- pared by Springborn Life Sciences, Inc. 74 p. 

### 72-5 Life cycle fish

MRID Citation Reference

41525901 Dionne, E.;Surprenant, D. (1990) The Ch ronic Toxicity of Fenpropathrin to the Fathead Minnow (Pimephales promelas ): Lab Study No.: 981-0687-6122-122: CEHC Reference No. 87-155. Unpubl ished study prepared by Springborn Laboratories, Inc., Environmental Sciences Div. 158 p.
42360001 Dionne, E.; Suprenant, D. (1992) The Ch ronic Toxicity of Fenpropathrin to the Fathead minnow (Pimephales promelas): Supplement to: Lab Project Number: 89-1-2913. Unpublished study prepared by Springborn Labs., Inc. 328 p.
43605301 Dionne, E. (1995) The Chronic Toxi city of Fenpropathrin to the Fathead Minnow (Pimephales promelas): Supplem ent II: Raw Data for "Fish Length and Reproduction, Diluter Calibration, and Control Solutions Analytical Measurements": Lab Project Numbers: 981.0687.6122.122: 981-6122: 981- 6122-122. Unpublished study prepared by Springborn Labs., Inc. 72 p.
43605302 Ginevan, M. (1995) The Chronic Toxi city of Fenpropathrin to the Fathead Minnow (Pimephales promelas): Supplement III: A Statistical Reevaluation of Data From the Study: Lab Project Number: V-11106. Unpublished study prepared by M.E. Ginevan & Associates. 61 p. 

### 72-7 Simulated or Actual Field Testing

MRID Citation Reference

71642 Shell Chemical Company (1975) Toxicity of the Pyrethroid Insecticides, SD 43775 and SD 41706, to Fish. (Unpublished study received Apr 9, 1981 under 6G1755; CDL:099983-S)
42378701 Flanagan, J. (1992) Letter Sent to Office of Pesticide Programs, dated June 24, 1992: Regarding an Ongoing Study Indicating Fenpropathrin may have Caused Effects on Aquatic Organisms in a Simula ted Aquatic Field Study (Mesocosm). Prepared by Valent. 9 p.
42800101 Springer, T. (1993) Simulated Aquatic Field Study Guideline Reference No. 72- 2 Preliminary Summary Biological Data: Fenpropathrin: Lab Project Number: 263-125. Unpublished study prepared by W ildlife International, Ltd. 111 p.
43958801 Springer, T.; Anderson, D.; Krueger, H. (1996) An Evaluation of the Impact of Fenpropathrin Insecticide Exposure on Aquatic Mesocosm Ecosystems: Amended Report: Lab Project Number: 263-125: VP-10056: 263/031292/DT2A/CYA9. Unpublished study prepared by Wildlife International Ltd. 2169 p.

70

### 81-1 Acute oral toxicity in rats

MRID Citation Reference

127342 Hiromori, T.; Misaki, Y.; Seki, T.; et al. (1983) Acute Oral Toxicity of S-3206 (91.8%) in Rats: Doc. Code FT-30-00 81. (Unpublished study received Apr 8, 1983 under 39398-16; prepared by Sumitomo Chemical Co., Ltd., Japan, submitted by Sumitomo Chemical America, Inc., New York, NY; CDL:249937- A)
127343 Kohda, H.; Miyamoto, J. (1975) Acute Oral Toxicity of S-3206 in Rats: Doc. Code FT-50-0018. (Unpublished study received Apr 8, 1983 under 39398-16; prepared by Sumitomo Chemical Co., Ltd., Japan, submitted by Sumitomo Chemical America, Inc., New York, NY; CDL:249937-B)
127344 Hiromori, T.; Misaki, Y.; Ito, S.; et al . (1982) Acute Oral Toxicity of S-3206 in Rats: Doc. Code FT-20-0076. (Unpublished study received Apr 8, 1983 under 39398-16; prepared by Sumitomo Chemical Co., Ltd., submitted by Sumitomo Chemical America, Inc., New York, NY; CDL:249937-C)
127345 Kohda, H.; Kadota, T.; Miyamoto, J. (1980) Acute Oral Toxicity of S-3206 Technical in Mice: Doc. Code FT-50-0035. (Unpublished study received Apr 8, 1983 under 39398-16; prepared by Sumitomo Chemical Co., Ltd., Japan, submitted by Sumitomo Chemical America, Inc., New York, NY; CDL:249937- D)
127346 Hara, S.; Suzuki, T.; Miyamoto, J. ( 1980) Acute Oral Toxicity of S-3206 in Rabbits: Doc. Code FT-00-0039. (Unpublished study received Apr 8, 1983 under 39398-16; prepared by Sumitomo C hemical Co., Ltd., Japan, submitted by Sumitomo Chemical America, Inc., New York, NY; CDL:249937-E)
127347 Pence, D.; Cameron, J.; Weatherhol tz, W. (1979) Oral Dose Range Finding Study in Dogs: S-3206: Project No. 343-123; Doc. Code FT-91-0025. Final rept. (Unpublished study received Apr 8, 1983 under 39398-16; prepared by Hazleton Laboratories America, Inc., submitted by Sumitomo Chemical America, Inc., New York, NY; CDL:249937-F)
127348 Misaki, Y.; Kohda, H.; Suzuki, T.; et al. (1981) Acute Oral Toxicity of Two Impurities of S-3206 (Technical) in Mice: Doc. Code FT-00-0044. (Unpublished study received Apr 8, 1983 under 39398- 16; prepared by Sumitomo Chemical Co., Ltd., Japan, sub- mitted by Sumito mo Chemical America, Inc., New York, NY; CDL: 249937-G)
127349 Misaki, Y.; Kohda, H.; Suzuki, T.; etal. (1981) Acute Oral Toxicity of 2,2,3,3- Tetramethylcyclopropane Carboxylic A nhydride in Mice: Doc. Code FT-90- 0045. (Unpublished study received Ap r 8, 1983 under 39398-16; prepared by Sumitomo Chemical Co., Ltd., Japan, submitted by Sumitomo Chemical America, New York, NY; CDL: 249937-H)
127353 Kohda, H.; Miyamoto, J. (1979) Acute Oral Toxicity of S-3206 10% Emulsifiable Concentrate in Mice: Doc. Code FT-80-0020. (Unpublished study received Apr 8, 1983 under 39398-16; prepared by Sumitomo Chemical Co., Ltd., Japan, submitted by Sumitomo Chemical Amer ica, Inc., New York, NY; CDL:249937-L)
127361 Stevenson, D.; Hend, R.; Butterworth , S. (1976) Toxicity Studies on the Insecticide WL 41706: A Short-term Feeding Study in Rats: TLGR.0041.76. (Unpublished study received Apr 8, 198 3 under 39398-16; prepared by Shell Research Ltd., Eng., submitted by Sumitomo Chemical America, Inc., New York, NY; CDL:249937-T)
128341 Johnson, D.; Myer, J.; Moxon, P.; et al . (1981) Acute Oral (LD50) Toxicity Study in Rats (EPA 8/78): (S-3206 2.4 Lb/G EC): IRDC Study No . 491-003; Doc. Code FT-11-0052. (Unpublished study received May 11, 1983 under 39398-16; prepared by International Research and Development Corp., submitted by Sumitomo Chemical America, Inc., New York, NY; CDL:250159-C)
42799801 Kiplinger, G. (1992) Acute Oral Toxici ty Study in Albino Rats with Danitol 2.4

71EC (Formulation CC-17228): Lab Project Number: WIL-194002. Unpublished study prepared by WIL Research Labs., Inc. 114 p.
43758602 Gabriel, D. (1995) Acute Oral Toxicity, LD50--Rats: TC-136 (Danitol/Orthene GH TR) Concentrate: Formula #147-043: Lab Project Numbers: 94-8126A: AOT-200. Unpublished study prepared by Biosearch Inc. 24 p.



### 141-1 Honey bee acute contact

MRID Citation Reference

164240 Atkins, E. (1984) Honey Bee Bioassays of Valencia Orange Foliage Residues of Fenpropathrin, Danitol, Sprays on Citrus. Unpublished study prepared by University of California. 4 p. 

### 141-2 Honey bee residue on foliage

MRID Citation Reference

164240 Atkins, E. (1984) Honey Bee Bioassays of Valencia Orange Foliage Residues of Fenpropathrin, Danitol, Sprays on Citrus. Unpublished study prepared by University of California. 4 p. 

### 142-3 Simulated or Actual Field Testing

MRID Citation Reference

71647 Johansen, C. (1975) Cooperator Pe rformance Report|. (Unpublished study received Apr 9, 1981 under 6G1755; submitted by Shell Chemical Co., Washington, D.C.; CDL:099983-Y)
127368 Harris, C.; Turnbull, S. (1978) Labora tory studies on the contact toxicity and activity in soil of four pyrethroid insecticides. Canadian Entomologist 110(Mar):285-288. (Submitter AW-81-00 99; also In unpublished submission received Apr 8, 1983 under 39398- 16; submitted by Sumitomo Chemical America, Inc., New York, NY; CDL:249939-B) 

### 143-2 Toxicity to Predators and Parasites in Fruit and Nut Crops

MRID Citation Reference

40024620 Whitehead, C. (1986) The Effect of Danitol 2.4 EC on Several Beneficial Insects and Mites in Various Crops: La boratory Project Identification 8613400. Unpublished study prepared by Chevron Chemical Co. 104 p.



### 850.1735 Whole sediment: acute freshwater invertebrates

MRID Citation Reference

47083801 Pearson, F. (2007) Pyrethroid Worki ng Group (PWG) Summary of Results from California Sediment Samples Analyzed for Pyrethroids. Project Number: PWG/2007/001. Unpublished study prepared by Morse Laboratories. 10 p.

72Appendix A. PRD data reque st justification tables

The following proposed Data Call-in tables include rationales for requiring the data requested in this problem formulation, expl anations of the util ity of the data, and explanations for how the data might impact risk assessment, following the format provided by PRD.

Guideline Number 835.2240 Study Title: Aqueous Photolysis

Rationale for Requiring the Data According to 40 CFR Part 158, Subpart N (Environmental Fate) §158.1300 (Environmental fate data requirements table), th ese data are required for all terrestrial use
patterns.

The available study was performed in the presen ce of high levels of cosolvent acetonitrile (around 8%). The study indicated that fe npropathrin was stable under the testing conditions. Supplemental data from other pr eviously reported st udies, indicated halflives ranging from 1.6 to around 113 days (further data repo rted by Laskowski 2002, half-lives 14.6 to 87.5 days). There is a high level of uncer tainty with respect to the levels of photolysis and there are no reliable data related to the possible transformation products. A new study is required to clarify these uncertainties.

Practical Utility of the Data
How will the data be used? Fenpropathrin is a synthetic pyrethroid with high toxicity towards aquatic organisms, including those living in th e benthos. Knowledge of its persistence in aquatic environments is important. The results of this study will be used in the environmental fate assessment, and later on, in the ecological risk characterization.

The latter studies submitted for fenpropathrin indicate relative stability for the compound, when compared to relatively small half-lives in other studies available, and in the field. Knowledge of the routes of dissipation w ith detail is essential for an accurate
environmental fate assessment.

In addition, the aqueous photolysis data will be used to derive the rate of reaction input parameters to be used in the aquatic models GENEEC2, PRZM/EXAMS and FIRST.
The results from these models are used fo r ecological risk estimation and in drinking
water exposure assessments.

How could the data impact the Agency’s future decision-making? Without these data, the Agency would have to make certain conservative assumptions (assume that fenpropathrin is stable to these processes, including the environmental fate assessment and the aquatic models). These conservative assumpti ons could lead to higher predicted concentrations (EECs), acco rding to the models, and consequently,

73Guideline Number 835.2240 Study Title: Aqueous Photolysis

higher risk quotients. Also, there would be a higher degree of uncertainty in the environmental fate assessment. Knowledge of these dissipation pathways in detail is essential to perform a bette r and accurate environmental fate assessment and risk

assessment.

The lack of these data will limit the flexibi lity the Agency and registrants have in coming into compliance with the Endangered Species Ac t and could result in use restrictions for fenpropathrin that may be unnecessary.

74Guideline Number: 835.4100 Study Title: Aerobic Soil Metabolism

Guideline Number: 835.4200 Study Title: Anaerobic Soil Metabolism Rationale for Requiring the Data According to 40 CFR Part 158, Subpart N (Environmental Fate) §158.1300 (Environmental fate data requirements table), th ese data are required for all terrestrial use
patterns.

At this time the Agency has one aerobic soil metabolism study, performed in one soil (152 days, SiL). Further supplemental data that has not been used in recent risk assessments, but that provides some compar ative information, indicated the following estimates of half-lives: 33-35 days (light clay) and 34-39 days (SCL). The problem with this early study was that it was conducted for only 30 days (required 365 days). High variability in the results fr om the supplemental study conducte d earlier (with shorter halflives) vs. the most recent study brings uncertainty to the environmental fate assessment. Aerobic soil metabolism half-lives, re ported by Laskowski 2002, are 34.1, 32.1, 34.8, 36.5, 39.4, 133, 34.7, 51.3, 221 & 186 days for SCL, C, SCL, C, SL, C, SL, SC, SC & L
soils. Rates of transformation should be determined in four soils. The registrant should submit a study conducted in three soils; a sandy loam soil should be included.

The available anaerobic study was performed wi th only one soil and for a period of only roughly 2 months of anaerobic incubation (with a reported half-life of 186 days, for a L soil). By way of comparison, other half -lives, reported by Laskowski 2002, are 283 & 383 days for C & SCL, respectively. Anaerobic studies with one soil type are generally
sufficient for the evaluation of transformati on pathways. Rates of transformation should
be determined in at least th ree additional soils (from Fate , Transport and Transformation
Test Guidelines – OPPTS Guideline 835.4100 & 835.4200 ). The study indicates that after the soil was flooded (converted to anaerob ic), the metabolism was very low. Data performed for a longer period of time will he lp the Agency to determine rates of transformation and presence of possible metabol ites. Studies should be conducted in four
soils. Practical Utility of the Data
How will the data be used? Fenpropathrin is a synthetic pyrethroid with high toxicity towards aquatic organisms, including those living in the be nthos. Knowledge of its pers istence in soil and aquatic environments is important. The results of this study will be used in the environmental fate assessment, and later on, in the ecological risk characterization.

In addition, the data will be used to derive th e rate of reaction input parameter to be used in the aquatic models GENEEC2, PRZM/ EX AMS, FIRST and SCI-GROW. The results from these models are used for ecological risk estimation and in drinking water exposure

assessments.

75Guideline Number: 835.4100 Study Title: Aerobic Soil Metabolism

Guideline Number: 835.4200 Study Title: Anaerobic Soil Metabolism How could the data impact the Agency’s future decision-making? Without these data, the Agency would have to make certain conservative assumptions ( e.g. use three times the single available aerobic soil metabol ism study half-life as the input for the aerobic soil metabolism in various of the models). These conservative assumptions could lead to higher predicte d concentrations (EECs), according to the models, and consequently, higher risk quotients. Also, there would be a higher degree of uncertainty in the environmental fate asse ssment. Knowledge of these dissipation pathways in detail is esse ntial to perform a better and accurate environmental fate
assessment and risk assessment.

The lack of these data will limit the flexibi lity the Agency and registrants have in coming into compliance with the Endangered Species Ac t and could result in use restrictions for fenpropathrin that may be unnecessary.

76Guideline Number: 835.4300 Study Title: Aerobic Aquatic Metabolism

Guideline Number: 835.4400 Study Title: Anaerobic Aquatic Metabolism Rationale for Requiring the Data According to 40 CFR Part 158, Subpart N (Environmental Fate) §158.1300 (Environmental fate data requirements table), th ese data are required for all terrestrial use
patterns.

No aerobic aquatic metabolism study has been submitted. The study is required and it
should be conducted in at least two sediments.

Two studies are available, performed in only one soil type (currently in review). These studies are currently in review. According to OPPTS Guideline 835.4300 and 835.4400

, “For the strictly anaerobic study, two sediments (includi ng their associated waters) should be sampled from the anaerobic zones of surface water bodies...” A study
conducted in one additional se diment type is required. Practical Utility of the Data
How will the data be used? Fenpropathrin is a synthetic pyrethroid with high toxicity towards aquatic organisms, including those living in th e benthos. Knowledge of its persistence in aquatic environments is important. The results of this study will be used in the environmental fate assessment, and later on, in the ecological risk characterization.

In addition, the data will be used to derive th e rate of reaction input parameters to be used in the aquatic models GEN EEC2, PRZM/ EXAMS and FIRST. The results from these models are used for ecological risk estim ation and in drinking water exposure

assessments.

How could the data impact the Agency’s future decision-making? Without these data, the Agency would have to make certain conservative assumptions ( e.g. use two times the aerobic soil metabolism half-life input value for the aerobic aquatic metabolism or two times the anaerobic soil metabolism half-life for the anaerobic aquatic metabolism in the aquatic models). These conservative assumptions could lead to higher predicted concentrations (EECs), acco rding to the models, and consequently, higher risk quotients. Also, there would be a higher degree of uncertainty in the environmental fate assessment. Knowledge of these dissipation pathways in detail is essential to perform a bette r and accurate environmental fate assessment and risk

assessment.

The lack of these data will limit the flexibi lity the Agency and registrants have in coming into compliance with the Endangered Species Ac t and could result in use restrictions for fenpropathrin that may be unnecessary.

77Guideline Number: None Study Title: Environmental Chemistry Methods (ECM) and Independent Laboratory Validation (ILV) for Soil, Water and Sediment Rationale for Requiring the Data According to the data requirements in 40 CFR Part 158, ECMs are currently required along with successful confirmatory method trials (validation) by an independent laboratory ( i.e. ILVs). The registrant submitted one method for soil (MRID 41679601, LOD 0.01 ppm, published in the Agency’s ECM website) 4 , that could quantify fenpropathrin and its metabolites 4’-OH-fenpropathrin and desphenylfenpropathrin in soil, using GC with a nitrogen/ phosphorous fl ame ionization detector. These levels of quantization may not be appropriate. Furthermore, the following studies have been
located and are curre ntly in review: MRIDs 71368 & 100138, 126817, 126818, 43958802 and 43958803 (the latter two studies ar e ILVs), and 47053001 and 47053002 (ECM and ILV). The Agency will verify the suitability of these methods and the appropriateness of their levels of quantization. In addition to the method for so il, at this time, methods are required for water and sediment. The results of previous assessments indicate that there
is risk for freshwater and estuarine/ marine fish, invertebrates and benthic organisms. Therefore, ECMs for water and sediment are required in addition to the ECM for soil. The ECMs should include parent and those resi dues found in the laboratory studies that exceed 10% of the applied (PBA, CONH 2 -fenpropathrin and COOH-fenpropathrin). The registrant is encouraged to submit state- of-the-art environmental chemistry methods; further, multi-residue methods (MRMs) for soil, water and sediment are preferred. Practical Utility of the Data
How will the data be used? The data will be used to verify the suitabili ty of the methods. Subsequently the methods could be used by states or other enforcement agencies, departments or entities, to monitor
concentrations of the residues of concern. Va lidated analytical methods in environmental media ( a.k.a. , ECMs) are useful for conducting and evaluating submitted environmental fate and toxicity field and monitoring studi es and for addressing pot ential risks to the environment posed by the use and/or accidental release of pesticides.

How could the data impact the Agency’s future decision-making? If monitoring of the chemical is required or performed, the Agency could be able to determine if the chemical is present in th e environment at concentrations that are threatening to wildlife (or to humans, in the case of drinking waters ), according to the levels of concern (LOCs). If that is the case, measures to prevent these concentrations to occur could be taken. The data could also be used by enforcement entities like the states or government agencies or departments. Without these data, the potential for the determination of residues of fenpropathri n and transformation products (PBA, CONH 2 - fenpropathrin and COOH-fenpropathrin) in soil , water and sediment is restricted. The lack of these data will limit the flexibility the Agency and registrants have in coming into compliance with the Endangered Species Act, and could result in us e restrictions for fenpropathrin which may otherwise be avoi ded, or which are unnecessarily severe.

4 Available at url: http://www.epa.gov/oppbead1/methods/ecmindex.htm

78Guideline Number: 850-2100 Study Title: Passerine Acute Avian Oral Rationale for Requiring the Data Although an acute avian oral study was rece ived for the Mallard duck, the Agency updated its data requirements in 40 CFR Part 158 (October 26, 2007) to include an acute oral toxicity study for both a pa sserine species and either a waterfowl or an upland game species. Prior to starting toxicity testing, a pr otocol will need to be provided for review.

o Many passerine species utili ze agricultural fields, fo rests, residential areas and surrounding areas, and, therefore, ha ve the potential to be exposed to pesticides used in agricultural, forest, and residential settings

 It is likely that, for most pesticid e use patterns, passerines are more likely to be exposed to pesticid es than upland game species and
waterfowl

o Passerines are smaller and have faster metabolisms than the waterfowl and upland game bird species traditionally used in avian toxicity tests which could impact their sensitivity to chemicals.

Practical Utility of the Data
How will the data be used? Data from passerine toxicity studies will be used to estimate potential risks to birds associated with uses of fenpropathrin. The data will reduce uncertainties associated with the current risk assessment for passerine species and will improve our understanding of the potential effects of fenpropathrin.

How could the data impact the Agency’s future decision-making? Because birds significantly contribute to overall environmental quality, a solid understanding of the potential risks to birds, including passerine specie s, is essential for sound environmental management. Without acceptable data for fenpropathrin, the Agency cannot determine the levels of fenpropa thrin that result in effects to passerine species. If the data indicates that registered usage may pose a risk of adverse effects to non-target birds above the Agency Level of Concern, the Agency may explore decision options to mitigate this risk. The lack of these data will limit the flexibility the Agency and registrants have in comi ng into compliance with the Endangered Species Act, and could result in use restrictions for fenpropa thrin which may otherwise be avoided, or which are unnecessarily severe.

79Guideline Number: 850.1400 Study Title: Aquatic Fish Early Life Stage (saltwater) Rationale for Requiring the Data

The acute toxicity of fenpropathrin to estu arine/marine fish and environmental fate properties indicates the potentia l for chronic exposure and eff ects to animals in this taxon, per 40 CFR Part 158 data requirements (O ctober 26, 2007). For example, the acute LC 50 for freshwater fish (2.2 μ g ai/L) is well below the 1.0 mg/L criterion specified in 40 CFR Part 158 for conditionally requiring this st udy. Furthermore, th e persistence of fenpropathrin in water is expected to subs tantially exceed the 4- d half life criterion specified in 40 CFR Part 158.

The Agency had conditionally required aquatic life stage studies for terrestrial food and nonfood, aquatic food and nonfood, forestr y, and domestic outdoor uses.

Practical Utility of the Data
How will the data be used? The estuarine/marine fish early life stag e study would allow the Agency to analyze chronic effects, including effects on reproductiv e success and growth, to saltwater species.
The effects data would be used to determ ine the likelihood that the chronic risks can potentially impact aquatic communities, either by direct effects on fish or by indirect effects by reducing their food sources. By refi ning the assessment, the Agency would be able to determine whether the mitigation imposed as part of the registration review process was appropriate due to toxici ty concerns with fenpropathrin.

How could the data impact the Agency’s future decision-making? If future endangered species risk assessmen ts are performed wit hout these data, the Agency would have to assume that fenpr opathrin "may affect" estuarine/marine endangered fish directly (and endangered specie s from other taxa indirectly), and use of fenpropathrin might need to be restricted in areas where endangered species could be exposed. The lack of these data will limit th e flexibility the Agency and registrants have in coming into compliance with the Endange red Species Act and could result in use restrictions for fenpropathrin which are unnecessarily severe.

80Guideline Numbers: Non-Guideline Study Title: Chronic whole sediment: Freshwater and marine invertebrates Rationale for Requiring the Data No chronic sediment toxicity tests for fres hwater or marine invertebrates have been submitted to satisfy the Agency’s updated data requirements for outdoor uses in 40 CFR Part 158 (October 26, 2007). For fenpropathri n, available information indicates that benthic organisms may be exposed via run-o ff or spray drift applications used in agricultural, forest, and residential settings. Specifically:

• The peak sediment porewater EECs pred icted for fenpropathrin (0.06 – 0.76 ppb) all exceed 0.1 of the acute LC/EC50 (0.021 ppb for M. bahia ), which satisfies one of the criteria for requiring chronic whol e sediment toxicity testing under 40 CFR
Part 158.

• The expected half-life of fenpropathrin in sediment (67-78 days for anaerobic aquatic metabolism) is substantially great er than 40 CFR Part 158 criterion of 10 days.

• The Kd values range from 64-810, the log Kow is 6, and K OC values range from 13870-85260, all of which exceed the third set of trigger criteria for requiring chronic testing (Kd > 50, or log Kow >3 or Koc > 1000)

• Finally, the potential for pe rsistent exposure from fenpropathrin in sediment is also indicated by open literature studies on pyrethroids (Weston et al. 2005, Amweg et al. 2006 and Ding et al. 2009).
For sediment studies involvi ng pyrethroids, chronic tests on Hyalella azteca

, Chironomus

tentans , and Leptocheirus plumulosus are requested. Although both are freshwater species, Hyalella and Chironomus differ substantially in their ecological niche (i.e., epibenthic vs. infaunal species), physiology, and potential sensitivities to pyrethroid exposure (e.g., Anderson et al. 2006; Maund et al., 2002). Fenpropathri n has the potential
to enter estuarine/marine water bodies base d on current usuage pa tterns that include coastal areas. Therefore, testing is required for Leptocheirus plumulosus , an estuarine/marine sediment-dwe lling invertebrate species. Practical Utility of the Data
How will the data be used? Data from sediment toxicity studies will be used to estimate potential risks to benthic organisms associated with uses of fenpropathrin. The data will reduce uncertainties
associated with the current risk assessme nt for benthic species and will improve our understanding of the potentia l effects of fenpropathrin.

How could the data impact the Agency’s future decision-making? Although there was uncertainty in estimating the effect of fenpropathrin on benthic organisms in previous assessments, there was a potential risk associated with adverse
effects identified for estuarine/marine acute and chronic organisms. Acceptable data for benthic organisms will reduce the uncertainty from the previous assessment If the data indicates that registered fe npropathrin usage may pose a risk of adverse effects to nontarget benthic organisms above the Agency Level of Concern, the Agency may explore decision options to mitigate this risk. The l ack of these data will limit the flexibility the Agency and registrants have in coming into compliance with the Endangered Species

81Act, and could result in use restrictions for fenpropathrin which may otherwise be avoided, or which are unnecessarily severe.

.

Guideline Numbers: 850.4150 and 850.4250 Study Title: Vegetative vigor and Seedling emergence, Tier I/Tier II Rationale for Requiring the Data No acceptable toxicity data are currently ava ilable to assess the risk of fenpropathrin to terrestrial plants.

Since fenpropathrin has outdoor uses, vegetativ e vigor and seedling emergence studies are required. These phytotoxicity data are needed to evaluate th e level of pesticide exposure to non-target terrestrial and aquatic plants and to assess the impact of pesticides on endangered and threatened plants. Practical Utility of the Data

How will the data be used? Data from terrestrial plant toxicity studies will be used to estimate potential risks to plants associated with uses of fenpropathrin. The data will reduce uncertainties associated with the current risk assessment for terrestrial plants and will improve our understanding of the potential effects of fenpropathrin on plants.

How could the data impact the Agency’s future decision-making? Because plants form the basis of most ha bitats and significantly contribute to overall environmental quality, a solid unde rstanding of the potential risk s to terrestrial plants is essential for sound environmental management. Without acceptable plant growth data for fenpropathrin, the Agency cannot determine th e levels of fenpropathrin that result in effects to terrestrial plants. If the data i ndicates that registered fenpropathrin usage may pose a risk of adverse effects to non-target terrestrial plants plants above the Agency Level of Concern, the Agency may explore decision options to mitigate this risk. The lack of these data will limit the flexibility the Agency and registrants have in coming into compliance with the Endangered Species Act, and could result in us e restrictions for fenpropathrin which may otherwise be avoi ded, or which are unnecessarily severe.

82Guideline Number: 850.4400 Study Title: Aquatic Vascular Plant Growth- Lemna spp. Tiers I/II

Rationale for Requiring the Data No acceptable studies for fenpropathrin have been submitted for vascular aquatic plants. The Agency has finalized its update to the data requirements in 40 CFR Part 158. In these updated data requirements, which were promulgated on October 26, 2007, vascular plant testing is requi red for pesticides such as fe npropathrin with outdoor uses.

Practical Utility of the Data

How will the data be used? Data from aquatic plant toxicity studies will be used to estim ate potential risks to plants associated with uses of fenpropathrin. The data will reduce uncertainties associated with the current risk assessment for aquatic plants and will improve our understanding of the potential effects of fenpropa thrin on vascular aquatic plants.

How could the data change the Agency’s d ecision, or impact the Agency’s future decision-making? Because plants form the basis of most ha bitats and significantly contribute to overall environmental quality, a solid understanding of the potential ri sks to aquatic plants is essential for sound environmental management. Without plant growth data for fenpropathrin, the Agency cannot determine th e levels of fenpropathrin that result in effects to vascular aquatic plants. If the data indicates that re gistered fenpropathrin usage may pose a risk of adverse effects to non-target aquatic vascul ar plants above the Agency Level of Concern, the Agency may e xplore decision options to mitigate this
risk.

If future endangered species risk assessmen ts are performed wit hout these data, the Agency would have to assume that fenpropa thrin "may affect" endangered plants and use of fenpropathrin might need to be restrict ed 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 compliance with the E ndangered Species Act and could result in use restrictions for fenpropathrin that may be unnecessarily severe.

83Guideline Number: 850.5400 Study Title: Algal toxicity test

, Tier I/II Rationale for Requiring the Data

No toxicity data are currently available to assess the risk of fenpropathrin to aquatic nonvascular plants. Since fenpr opathrin has outdoor uses, Ti er I/II aquatic nonvascular plant studies are required. These phytotoxicity data are needed to evaluate the level of pesticide exposure to non-target aquatic plants and to assess the impact of pesticides on endangered and threatened plants. Practical Utility of the Data

How will the data be used? Data from Tier I/II nonvascular aquatic plant toxicity studies will be used to estimate potential risks to plants associated with uses of fenpropathrin. The data will reduce
uncertainties associated with the current ri sk assessment for nonvascular aquatic plants and will improve our understanding of the potential effects of fenpropathrin.

How could the data impact the Agency’s future decision-making? Because plants form the basis of most ha bitats and significantly contribute to overall environmental quality, a solid understanding of the potential risks to nonvascular aquatic plants is essential for sound environmental ma nagement. Without plant growth data for fenpropathrin, the Agency cannot determine th e levels of fenpropathrin that result in effects to aquatic plants. If the data indicates that register ed usage may pose a risk of adverse effects to non-target aquatic nonvasc ular plants above the Agency Level of Concern, the Agency may explore decision options to mitigate this risk. The lack of these data will limit the flexibility the Agency a nd registrants have in coming into compliance with the Endangered Species Act, and could result in use restric tions for fenpropathrin which may otherwise be avoided, or which are unnece ssarily severe.

84Guideline Number: 850.1010 Study Title: Aquatic Invertebrate Acute Toxicity ( Hyalella Azteca ) Rationale for Requiring the Data

Available information in the ECOTOX databa se indicates that the freshwater amphipod, Hyalella azteca , is substantially more sensitive to pyrethroids than Daphnia magna , the commonly tested freshwater invertebrate. Information on the acute toxicity of fenpropathrin to H. azteca was not identified in this probl em formulation. Therefore, in order to ensure that risk to sensitive aqua tic invertebrates are appropriately quantified, additional acute toxicity testing of H. azteca is needed (water column exposure, not sediment-spiked)

.

Practical Utility of the Data
How will the data be used? The freshwater acute toxicity study with Hyalella would allow the Agency to analyze acutely toxic effects to one of the most sensitive species of freshwater aquatic
invertebrates. The effects data would be us ed to determine the lik elihood that acute risks can potentially impact aquatic communities, either by direct effects on invertebrates or by indirect effects by reducing the food source for their predators (e.g., fish ). By refining the assessment, the Agency would be able to determine whether the mitigation imposed as part of the registration review process was appropriate due to toxicity concerns with fenpropathrin.

How could the data impact the Agency’s future decision-making? If future risk assessments are performed w ithout these data, the Agency would have to account for the potential increased sensitivity of Hyalella to fenpropathrin using other means which may include using an extrapolat ion factor based on sensitivity differences with other pyrethroids. Sin ce this extrapolation factor w ould involve uncertainty, it is likely that a conservative factor would be a pplied. This may impinge on the Agency’s flexibility in coming into compliance with th e Endangered Species Act and could result in use restrictions for fenpropathrin which are unnecessarily severe.

85