2 overall persistence in the environment. Due to the very low solubil ity of cyfluthrin and beta -cyfluthrin, there is also concern with resp ect to the results of the batch equilibrium study. There is uncertainty concerning the poten tial for adverse aquatic effects, including benthic environments, for acute, chronic a nd endangered species risk based on fate transport involving drift and run-off, and persis tence. There is uncertainty concerning the potential for adverse terrestrial effects for acute and endange red species risk to birds, terrestrial invertebrates and pl ants based on fate transport, drift, binding to the soil, and persistence. In addition, ther e are ecological data gaps that need to be addressed for cyfluthrin and beta -cyfluthrin. For cyfluthrin, this in cludes acute effects to passerine birds, acute effects to freshwat er fish and estuarine/marine organisms, chronic effects to benthic organisms, and toxicity to terrestria l and aquatic plants. For beta-cyfluthrin, data gaps include chronic effects to aquatic invertebrates and toxici ty to terrestrial and aquatic plants. The potential for advers e effects to pollinators and ot her beneficial insects from use of cyfluthrin and beta -cyfluthrin appears to be high.3 

# Environmental Fate and Ecological Risk Assessment Problem Formulation in

Support of Registration Review for Cyfluthrin and Beta -cyfluthrin

Cyfluthrin Beta -cyfluthrin

Unstated stereochemistry, consists of eight isomers



# July 29, 2010



# Environmental Fate and Effects Division Office of Pesticide Programs US Environmental Protection Agency4 Prepared by: Amanda Solliday, Biologist José L. Meléndez, Chemist

Secondary Review: Keith Sappington, Senior Scientist Mah T. Shamim, Ph.D., Branch Chief

Environmental Risk Branch V5 Table of Contents

1. Purpose..................................................................................................................... ... 9 2. Problem Formulation ............................................................................................... 9 2.1. Nature of Regulatory Action ............................................................................... 10 2.2. Previous Risk Assessments and Scientific Advisory Panels ................................. 10 3.1. Mechanism of Action............................................................................................. 21 3.2. Overview of Pesticide Usage ............................................................................... 22 In addition to the classical agricultural use sites, cyfluthrin and beta-cyfluthrin have multiple o ther uses. Cyfluthrin and beta-cyfluthrin may be used in multiple urban environments. Many of these uses are cl assified as outdoor re sidential such as ornamental lawns and turf, recreation area la wns, ornamental and/ or shade trees, ornamental herbaceous plants, ornamental woody shrubs and vines, paths/ patios, paved areas (private roads/ sidewalks), pet living/ sleepi ng quarters, a nd residential lawns. Tables 3.4a and 3.4b provide a summ ary of the terrestria l nonagricultural use sites for cyfluthrin and beta-cyfluthrin, resp ectively. Application methods vary. Many of these uses could involve substantive exposure to wildlife, specifically, aquatic organisms, and they will be assessed accordingly (e.g., commercial/ industrial lawns, residential lawn, golf course turf, orname ntal lawns and turf, recreation areas and residential lawns). (Note that there are fewer non-food uses for beta-cyfluthrin than for cyfluthrin.) Another use that will be evaluated is wood protection treatment (outdoors)...................................................................................................................... 30 In addition, there are several other indoor non-food or indoor residential use sites for both cyfluthrin and beta-cyfluthrin, like for example, commercial/institutional/industrial prem is es/equipment (indoor), dairies/cheese processing plant premises (nonfood contact), eating establishments, food processing plant premises (nonfood contact), food stor es/ markets/ supermarkets premises, hospitals/ medical institutions premises a nd household/ domestic dwellings. Cyfluthrin and beta-cyfluthrin also have greenhouse uses............................................................. 32 It is important to recognize that the active i ngredient and the synergist have differing fate properties and therefore would be expected to occur in the en vironm ent at different times and at different concentrations than present in the end use product. Consequently, it is necessary to have toxicology da ta which allows the assessment of the level of synergy as the ratio of the pesticide and s ynergist vary in the environment. Datasets which allow the calculation of the ‘pesticide-synergist intera ction’ are often not available. EFED recognizes the limitations inherent in this appr oach and is looking into the acquisition of data that would allow the eval uation of the effect of both s ynergist and active ingredient when present in the ecosystem. Evaluating th e potential toxic effects of the synergist include evaluating ecological e ffects data generated using en d-use products and the active ingredient in the presence of synergists, in addition to data for the active ingredient alone. At this time, EFED typically has data for indi vidual active ingredients, as well as for the synergists alone, but few data are available fr om which to draw conclusions regarding the potential effect of the combination. As stat ed above, the Agency is evaluating its options for obtaining data appropriate for this type of evaluation................................................. 33 3.3. Environmental Fate and Transport......................................................................... 34 4. Receptors ................................................................................................................. 40 4.1. Aquatic and Terrestrial Effects .......................................................................... 406 4.2. Incident Database Review ................................................................................... 48 4.3. Ecosystems Potentially at Risk ........................................................................... 51 6. Conceptual Model ................................................................................................ 53 6.1. Risk Hypothesis .................................................................................................. 53 6.2. Conceptual Diagram .......................................................................................... 54 Indoor uses can result in discha rges of cyfluthrin and beta-cyfluthrin into sewer system s and subsequently into publicly owned tr eatment works (POTWs), and to aquatic ecosystems. These discharges of cyfluthrin and beta-cyfluthrin will be included in the assessment as a possible route of exposure to the environment. Exposure estimates could be used to evaluate potential effects to eco logical entities. The conceptual model for potential risks of cyfluthrin or beta -cyfluthrin to aquatic organi sms due to various indoor uses of the chemical that could potentially end up in a “drain” is depicted in Fig. 6.2

. The stressor is the chemical of concern, cyfluthrin and beta -cyfluthrin. It is noted that the transport pathway is wastewater flow, the expos ure media is the treatment facility, but the exposure point or route, receptor and attribut e changes for aquatic organisms are similar to the conceptual model for agricultural and urban applications (as depicted in Fig. 6.1a ).

............................................................................................................................... ............ 57 7. Analysis Plan ........................................................................................................ 58 7.1. Stressors of Concern .............................................................................................. 59 7.2. Measures of Exposure .......................................................................................... 59 7.3. Measures of Effect ................................................................................................. 61 7.4. Integration of Exposure and Effects ...................................................................... 62 7.5. Deterministic and Probabilistic Assessment Methods........................................... 62 7.6. Endangered Species Assessments.......................................................................... 63 7.7. Drinking Water Assessment .................................................................................. 64 7.8. Endocrine Disruptor Screening Program ......................................................... 64 7.9. Preliminary Identification of Data Gaps .......................................................... 65 7.9.1. Fate ................................................................................................................. 65 7.9.2 Effects .............................................................................................................. 69 Trimble, A.J, D.P. Weston, J.B. Belde n, and M.J. Lydy. 2009. Identification and Evaluation of Pyrethroid Insecticide Mixtures in Urban Sedim ents. Environ Toxicol & Chem 26 (8) pp. 1687–1695. ........................................................................................ 82 9. Fate and Eco-Toxicity Bibliography ....................................................................... 84 Environmental Fate Cyfluthrin ..................................................................................... 84 161-1 Hydrolysis ............................................................................................ 84 161-2 Photodegradation-water ................................................................... 84 161-3 Photodegradation-soil ...................................................................... 84 162-1 Aerobic soil metabolism .................................................................. 85 162-4 Aerobic aquatic metab. ..................................................................... 85 163-1 Leach/adsorp/desorption ................................................................. 85 163-3 Volatility - field .................................................................................... 86 164-1 Terrest rial field dissipation ............................................................. 86 165-2 Fiel d rotational crop .......................................................................... 87 165-4 Bio accum ulation in fish ................................................................... 87 202-1 Dr ift field evaluation .......................................................................... 87 850.7100 Data reporting fo r environmental chemistr y methods ...... 877 Environmental Fate Be ta -Cyfluthrin ............................................................................ 88 162-4 Aerobic aquatic metabolism ........................................................... 88 Ecological Effects Cyfluthrin ......................................................................................... 88 71-1 Avian Si ngle Dose Oral Toxicity ...................................................... 88 71-2 Avia n Dietary Toxicity ......................................................................... 88 71-4 Avian Reproduction ............................................................................. 89 71-5 Simulated or Actual Fie ld Testing ................................................... 89 72-1 Acute Toxic ity to Freshwater Fish ................................................... 89 72-2 Acute Toxicity to Freshw ater Invertebrates .................................. 91 72-3 Acute Toxicity to Estuarine/Marine Organisms ........................... 92 72-4 Fish Early Life Stage/ Aquatic Invertebrate Life Cy cle Study ... 93 72-5 Fish Full Lifecycle Study .......................................................................... 94 72-7 Simulated or Actual Fie ld Testing ................................................... 94 123-2 Aquatic plant growth ......................................................................... 94 141-1 Honey bee acute contact ................................................................. 95 141-2 Honey bee residue on foliage ......................................................... 95 850.1790 Chironomid Sediment Toxicity Test ....................................... 95 Appendix A. PRD data re quest justification tables ................................................... 97 Appendix C. Open Literature Information.................................................................. 118 The following is a cursory search of the ava ilable literature oncyfluthrin, betacyfluthrin and synthetic pyr ethroids in general, mostly about their prevalence/ occurrence, and about their toxicity to a quatic invertebrates and sediment dwelling organisms (which also pertains to Section 4.1). It is not intended to be exhaustive. In the relatively recent past there has been an increased awareness of the prevalence and toxicity of cyfluthrin, and other synthetic pyrethroids, in sediment environments of urban and agricultural sites, particularly in California. .............................................. 118 Cyfluthrin is among the constituents monitored by the National Water Quality Assessm ent (NAWQA), maintained by the U. S. Geological Survey. Two kinds of parameters (types of samples) are reporte d. One is “Cyfluthrin_ water_ filtered_ recoverable_ micrograms per liter,” with a reported percent of samples with this parameter of 9.7 (report units of μ g/L). The other is “Cyfluthrin_ solids_ recoverable_ dry weight_ micrograms per kilogram,” with a reported percent of samples with this parameter of 0.1 (report units of μ g/Kg)..................................................................... 120 Multiple articles from the literature document the presence of synthetic pyrethroids, including cyfluthrin, in both urban and agricultural sedim ents. Weston et al. 2005, studied the presence of synthe tic pyrethroids in Roseville, CA, selected as a typical suburban development. Sediments from creeks that drain subdivisions of single-family homes were found to be toxic to Hyalella azteca. The sediments were tested for several pesticides, including 7 pyrethroids. Bifenthrin was present in all the sediment samples. It was considered to be the primary cause of the toxicity towards the organism, with additional contributions of the pyrethroids cyfluthrin and cypermethrin. The maximum concentration of cyfluthrin was found to be 169 ng/g dry weight, for a tributary of Kaseberg Creek, in sampling si te 11. It was detected in 12 out of 24 sediment samples. The authors indicate that the presence of synt hetic pyrethroids was not likely to be due to agri cultural uses. In Placer County, the use of synthetic pyrethroids for agricultural purposes was reported to amount to around 1%............. 1208 Amweg et al. 2006b also studied synthetic pyre throids in urban areas of California and Tennessee. Bifenthrin w as found to be th e major contributor to the toxicity of sediments sampled in California to Hyal ella azteca, due to its high reported concentrations and toxicity. Cypermethr in, cyfluthrin, deltamethrin and lambdacyhalothrin may have contributed to the toxicity in some of the sites. The concentrations of cypermethrin and cyflut hrin were typically higher than for other synthetic pyrethroids (usually 2-30 ng/g ), but the bifenthrin and permethrin concentrations were the highest. On th e other hand, in Tennessee only a few samples contained synthetic pyrethroids and none of the samples were toxic to Hyalella azteca. The differences between the two sites were at tributed to different climate, types of residential development and pesticide use practices................................................... 120 Holmes et al. 2008 presented the occurrence a nd toxicity of the s ynthetic pyrethroids throughout the state of Californi a’s urban creek sedim ent sa mples. First, 90 samples were screened for toxicity to Hyalella azteca, of which around one third caused significant toxicity to the organism. Later, 30 sample locations were selected for the final study. Of the 30 samples, 25 were to xic to Hyalella azteca at 23oC and all 30 samples were toxic at 15oC (the synthetic pyrethroids often show higher toxicity at lower temperatures, as indicated above). Se ven of eight pyrethroids were detected in the sediment samples. Fenpropathrin was not detected in any of the samples, and deltamethrin and esfenvalerate were detected infrequently; but bifenthrin was present in all the 30 samples (2.19 to 219 ng/g dry we ight). Permethrin was the second most detected pyrethroid and cyfluthrin was de tected in 16 samples, with a highest concentration of 127 ng/g dry weight. The re sults suggested an important role of the synthetic pyrethroids in California’s urba n creeks sediment toxicity. Bifenthrin accounted for around two thirds of the toxicity on an average basis, with cyfluthrin and cypermethrin also playing an important ro le in the pyrethroid toxicity statewide. .... 1219 1. Purpose

The purpose of this problem formulation is to provide the foundation for the ecological risk assessment being conducted for the registered uses of cyfluthrin and beta -cyfluthrin. As such, it articulates the pur pose and objectives of the risk assessment, evaluates the nature of the problem, and provides a plan fo r analyzing the data and characterizing the risk (USEPA, 1998). Additionally, this problem formulation is intended to identify data gaps, uncertainties and potential assumptions needed to address those uncertainties in characterizing the ecological risk associated wi th the registered uses of cyfluthrin and beta -cyfluthrin.

Cyfluthrin is a Type II synthetic pyrethroid in secticide that is registered for numerous agricultural, non-agricultural a nd residential uses, such as (but not limited to) alfalfa, almond, apple, beans, brassica (head and stem) vegetables, carrots, citrus, corn, cotton, cucurbit vegetables, fruiting vegetables, grapes, hops, leafy vegetables, legume vegetables, lettuce, peach, peanuts, peas, pom e fruits, potato, root and tuber vegetables, sorghum, soybeans, stone fruits, sugarcane, sunflower, tomato, tree nuts, wheat, airport/ landing fields, animal kennels/ sleeping quarter s, barns, warehouse premises, industrial lawns, eating establishments, food proce ssing plant premises, golf course turf, greenhouses, domestic dwellings, rights-of- way, ornamental and/ or shade trees, ornamental lawns, tobacco and wood protec tion to buildings. Type II pyrethroids are characterized by the cyano moie ty in their chemical struct ure (Type I pyrethroids do not contain this moiety, see Mechanism of Action for additional distinct ions between the two types). Cyfluthrin is a mixtur e of eight possible isomers.

Beta -cyfluthrin consists of four of the eight possible isom ers of cyfluthrin, which are the more potent isomers of cyfluthrin. Thus, its appl ication rate is usually lower than that for cyfluthrin. The environmental fate and ecolo gical effects properties of cyfluthrin and beta -cyfluthrin are expected to be similar to each other. Although beta -cyfluthrin registrations are separate from cyfluthrin, th e environmental fate and ecological database for beta -cyfluthrin has been largely supplemen ted by available data for cyfluthrin.

Beta -cyfluthrin is registered also on numerous agricu ltural, non-agricultural and residential uses such as (but not limited to) alfalfa, apple, beans, brassica (head and stem) vegetables, broccoli, cabbage, canola, carrot, cashew, citrus, corn, cotton, peas, cucurbit vegetables, fruiting vegetables , grass forage/ fodder/ hay, hop s, leafy vegetables, legume vegetables, lettuce, mustard, pastures, peach, peanuts, pear, pecan, pepper, pome fruits, potato, plum, rangeland, root a nd tuber vegetables, sorghum, soybeans, stone fruits, sugarcane, sunflower, tomato, tree nuts, wh eat, sugarbeets, tobacco, agricultural/ farm premises, animal kennels/ sleeping quarte rs, automobiles, barns, Christmas tree plantations, commercial/ industrial lawns, fencerows/ hedgerows, greenhouse – empty, hospitals/ medical institutions premises, domestic dwellings, ornamental and/ or shade trees, ornamental lawns and turf, paths/ pa tios, paved areas, recreation area lawns, residential lawns and wood prot ection treatment to buildings.

2. Problem Formulation10 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 cyfluthrin and beta -cyfluthrin. Previous risk assessments were completed for the uses of th ese chemicals, which serve as the basis for this assessment.

The Food Quality Protection Act (FQPA) 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 determine whether cyfluthrin and beta -cyfluthrin continue to meet the FIFRA standard for re gistration. This problem formulation for the environmental fate and ecological risk asse ssment chapter in support of the registration review is intended for the in itial docket opening the public ph ase of the review process.

2.2. Previous Risk Assessments an d Scientific Advisory Panels

Previous Assessments Recent risk assessm ents conducted on cyfluthrin and beta -cyfluthrin, indicated risk concerns for freshwater and es tuarine/marine organisms. In addition, there were risk concerns for organisms living in the benthos.

In June and July 2007, EFED issued three in cremental risk assessm ents (an assessment for uses for which the risk for cyfluthrin ar e similar to those previously identified) for proposed new uses of cyfluthrin (D331952+), beta -cyfluthrin (D332314+), and cyfluthrin and beta -cyfluthrin (D340740+). The first new use risk assessment for cyfluthrin, covered its use of the chemical on grasses; the second new use risk assessment for beta

cyfluthrin covered its uses on grasses, Cr op Group #15 (cereal grains except rice) and Crop Group #16 (forage, fodder and straw of cereal grains); finally, th e third new use risk assessment for cyfluthrin and beta -cyfluthrin covered the increased application rate for alfalfa (maximum applicati on rate 0.175 lb a.i./A/season for cyfluthrin and 0.35 lb a.i./A/season for beta -cyfluthrin). All three reviews relied upon previously issued assessments ( e.g. high application rates for sweet corn at a rate of 0.44 lb a.i./A/season,11 and cotton at a rate of 0.5 lb a.i./A/seas on). These assessments concluded that the potential risks associated with newly proposed crops or maximum application rates were within the range of risks identi fied by previously issued risk assessments and overall risks should be similar.

Also in June 2007, the EFED issued an increm ental risk assessment for the proposed new use of PONCHO BETA (EPA Reg. No. 264-1056), a product containing both, chlothianidin and beta -cyfluthrin, for the use for seed treatment on sugar beet seeds (D335254). The single applicati on rate for the chemical beta -cyfluthrin is 0.0125 lb a.i./A, and the risks were based on a previ ously issued assessment for the use of cyfluthrin on tobacco, with a similar applica tion rate. It was indicated that“generally, seed treatments result in less risk to aqua tic organisms due to a lower potential for exposure since the seed is normally covered and th ere is little or no pe sticide drift. Also, application rates per ac re are usually lower than normal spray treatments.” A seed leaching study was required for clothianidin and beta -cyfluthrin.

Prior to this assessment, in 2006, a risk assessm ent was issued for the use of cyfluthrin on tobacco (D316313). The application rate for to bacco is 0.0044 lb a.i./A, with a single application allowed. This is only a small fr action of the applicati on rate on several other crops. Regarding risk to terrestrial and aquatic organisms, it was concluded that there was a potential for non-target aquatic organisms (freshwater and estuarine/ marine, fish and invertebrates) to be exposed to cyfluthrin via off target spray drift and/ or runoff into surface water. The results indicated that chro nic levels of concern (LOCs) were exceeded for estuarine/ marine invertebrates with a risk quotient (RQ) of 1.35. For the proposed maximum application rate on t obacco, the acute or chronic RQ s for benthic invertebrates did not exceed the LOCs. Also, there were no acute or chronic risks to birds or mammals from a single application of cy fluthrin to tobacco. Cyfluthrin is very highly toxic to honey bees on an acute contact basis, therefor e, risk was assumed. Risks to aquatic and terrestrial plants were not asse ssed because data were not av ailable. Nonetheless, due to cyfluthrin’s mode of action and lack of incidents pert aining phytotoxicity for the chemical or other pyrethroid pesticides, there were no phytot oxicity concerns stated in the risk assessment. The environmental fa te and ecological eff ects databases were considered mostly complete, but an aerobi c aquatic metabolism study was required. In addition, it was indicated that acute freshwater and chronic estuarine/ marine sediment studies were received as follows. The studies are currently in review.

MRID 46591507 Cyfluthrin – Toxicity to Midge ( Chironomus tentans ) During a 10-Day Sediment Exposure.

MRID 46591506 Cyfluthrin – Toxicity to Estuarine Amphipods ( Leptocheirus plumulosus ) During a 28-Day Sediment Exposure.

Finally, the tobacco risk assessment also provid ed a fate characterization for cyfluthrin. In short, it w as indicated that cyfluthrin is moderately persistent in the environment (terrestrial field dissipati on half-lives 18 to <32 days; aerobic soil metabolism 73.5-94.8 days; anaerobic soil metabolism of the order of about 30 days), and practically immobile (K d s ranged from 1116 to 1793 mL/g, K OC 's ranged from 73,480 to 124,000 mL/g OC ).12 [Note: According to the currently used mob ility classification (FAO 2000), cyfluthrin is considered immobile to hardly mobile.] It wa s also pointed out that the primary routes of dissipation for cyfluthrin are hydrolysis in alkaline media (half-life 2.1 days), and aqueous and soil photolysis (respective half-l ives of 4.5 and 5.6 days). Cyfluthrin is resistent to hydrolysis in aci dic and neutral media. It bi nds strongly to soil suggesting little potential to leach to subsurfaces and to contaminate ground water. Nonetheless, cyfluthrin appeared to have a high potential to reach surface waters by spray drift or in runoff events accompanied by erosion, with cyfluthrin bound to particulate and organic matter in the water column. It was also indi cated that the chemical has the potential for deposition in the benthos, accumulating with re peated use. Cyfluthrin was not expected to volatilize, based on its moderately low He nry's Law constant, lo w vapor pressure and binding capacity. This chemical bioaccumula tes moderately (854X for total residues, whole fish), with relatively rapid depuration (observed DT 50 for depuration ≤ 3 days). Degradates observed in the studies include d DCVA, FPB-ald and FPB-acid, all of which are product of pyrethr oid ester cleavage.

In 2004, the EFED issued a risk assessment for several proposed new uses as follows: tree nuts, grapes and peanuts, wheat, leafy vegetables, frui ting vegetables, cucurbits, leafy brassica, pome fruit, stone fruit. In addi tion, the registrant seeked to establish IR-4 tolerances for the use of cyfluthrin on tube rous and corm vegetabl es (crop Subgroup 1C), turnip greens, dried shelled peas and beans (except soybeans), grass hay, and grass forage (D274813+). Regarding the risk to terrestrial organisms, it was concluded that there were no acute or chronic risks to bi rds from applications of cyfl uthrin. However, for small 15- 35 g mammals, acute LOCs were slightly exceeded for single and multiple application scenarios. As in the case for the assessm ent for use on tobacco, risk was assumed for nontarget terrestrial insects; and for semi-aqua tic and terrestrial plant, data were not required.

In the 2004 assessment, most acute, chronic, restricted use and endangered species LOCs were exceeded for aquatic organisms (freshwater and estuarine/marine fish and invertebrates). Acute RQs based on rainbow trout ranged from 1.5 to 39 while chronic RQs ranged from 0.45 to 30. For freshwater inve rtebrates, the results indicated that acute RQs for daphnia ranged from 4 to 107 and fo r crayfish ranged from 1.7 to 43. Chronic RQs for daphnia ranged from 1.3 to 61. For estuarine/marine fish, acute RQs based on sheepshead minnow ranged from <0.01 to 0.70 while chronic RQs ranged from 0.10 to 12. For estuarine/marine invertebrates, the results indicated that acute RQs for mysids ranged from 48 to 1214 and for shrimp surrogate crayfish ranged from 1.7 to 43. Chronic RQs for mysids ranged from 45 to 2130. In addi tion, based on the risk of cyfluthrin to fish, exposed amphibians were also assumed to be at risk due to a portion of their lifecycle being spent in aquatic environments, pa rticularly the early life stages that are primarily aquatic and where respiration is de pendent on gills (such as tadpoles) or where later adult stages retain external gill structur es (primitive salamanders). It was indicated that amphibians often inhabit shallow litoral areas where incoming runoff concentrations of cyfluthrin may be the highest.

In 2001, the EFED issued an in cremental risk assessment fo r the use of cyfluthrin on Southern peas (D271494). Conclusions were based on the previously issued assessment13 of the same or similar use in the year 2000 (see below).

In 2000, the EFED also conducted an assessmen t for the use of cyfluthrin on leafy vegetables (lettuce, mustard greens, cauliflo wer and broccoli), soybeans, corn (pop, field, and seed), dry peas, pigeon peas, chick p eas, and lentils (D256960+). The following was stated in the review: “Cyfluthrin poses a risk to freshwa ter and estuarine/marine fishes and invertebrates based on the highest sugge sted application rates for all proposed commodities based on corn (pop, seed, and field), leafy vegetables, and soybeans. Levels of concern (LOCs) for freshwater fishes a nd freshwater invertebrates and estuarine/ marine invertebrates were exceeded on an acute and chronic basis. Chronic data for the freshwater rainbow trout showed LOC exceed ance while chronic data for the fathead minnow did not show an exceedance of LOCs when multiple applications of cyfluthrin was used. Semi-aquatic and terrestrial plant data is not required due to the results of previous phytotoxicity testi ng with a pyrethroid surrogate (cypermethrin) which showed no evidence of phytotoxicity. Based on the re gistrant submitted studies, cyfluthrin appears to be poorly mobile and moderately pe rsistent in the environment. Because of cyfluthrin’s low mobility, it should not reac h ground water in significant quantities, but does have the potential for surface water contam ination through drift and erosion where it will become sorbed mainly on sediment.”

1999 Scientific Advisory Panel A FIFRA Scientific Advisory Panel (SAP) in 1999 examined the sediment toxicity and fate of synthetic pyrethroids. In response to a questi on regarding whether sediment toxicity data on one pyrethroid (cypermethrin) could be used to predict sediment toxicity to all pyrethroids, the panel generally suppor ted the method of using data from a few pyrethroids to extrapolate information on toxi city to other pyrethroids. Also, the new CFR Part 158 requirements include sediment toxicity tests and these studies are considered particularly important for eco logical risk assessment of all synthetic pyrethroids, includi ng cyfluthrin and beta -cyfluthrin.

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 estimates partitioning across a wide variety of soil/ sediment 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.

While the biota-sediment accumulation 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 a ccount for sorption of14 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 cyfluthrin and thr ee other synthetic pyret hroids: cypermethrin, esfenvalerate and bifenthrin (memora ndum dated 12/22/03, Rexrode & Meléndez):

850.1735: 10-day Sediment (freshwater) - Test organism: Hyalella azteca and Chironomus dilutus

. - Duration: 10 days, endpoint is survival.

EPA/600/R01/020: Chronic Estuarin e/Marine Sediment Testing - 28 day test on Leptocheirus plumulosus

. - Percentage of neonates that survive as adults. - Growth rate. - Reproduction (#eggs/ female, etc .). - Behavior.

A chronic 65-day freshwater test was also requested only for cypermethrin.

EPA/600/R-991064: Chronic Freshwater Sediment Testing - 65 day test on Chironomus dilutus

. - Survival. - Growth rate. - Reproduction (# eggs/ female, time to oviposition, proportion of females ovipositing, % hatch).

2009 Scientific Advisory Panel OPP presented a “Proposed Common Mech anism Grouping for the Pyrethrins and Synthetic Pyrethroids to a FIFRA SAP in June 2009. OPP proposed two subgroups based on Type I or Type II effects related to sodium current tails and neurobehavioral impact, with esfenvalerate and fenpropat hrin showing symptoms of both types. Cyfluthrin and beta -cyfluthrin are Type II synthetic py rethroids, which means they are cyano-substituted in the alpha position. The panel indicated th at substances with mixed characteristics could be in cluded in both groups (see p. 18 of SAP minutes, USEPA 2009). This mechanism of action as sessment was performed by HED/OPP and presented to the SAP to determine if a cumulative assessment is required for the synthetic pyrethroids. However, EFED does not curr ently conduct cumulative assessments. EFED does not currently have the methodology to c onduct similar cumulative risk assessments for all of the (non-human) biological enti ties for which EFED has responsibility. Although EFED agrees that an assessment of cumulative risk would be a desirable goal, EFED does not believe the current state of the science can address this issue quantitatively. The ecological risk assessment for cyfluthrin and beta -cyfluthrin will consider open literature, modeling and othe r lines of evidence, as available, to qualitatively address the potential for cumu lative effects in the risk assessment.15 Information on the 2009 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 over cyfluthrin, beta -cyfluthrin and other pyrethroids’ toxic ity towards benthic and other non-target aquatic organisms. Also, the articles illustrate cyfluthrin’s prevalence in the environment. Please, refer to the Appendix C 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 document has not been published for cyfluthrin or beta -cyfluthrin ( 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 cyfluthrin and beta -cyfluthrin, no aquatic life benchmarks have been published ( http://www.epa.gov/oppefed1/ecorisk_ders/a quatic_life_benchm ark.htm#benchm arks ).

Impaired Water Bodies Cyfluthrin and beta -cyfluthrin are not individually identi fied as a cause of impairment for any water bodies listed as impaired under se ction 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, California: Del Puerto Creek, Ingram Creek Site (from confluence with Ho spital Creek to Highw ay 33 crossing) and second Ingram Creek Site (from confluence w ith San Joaquin River to confluence with Hospital Creek).

Nonetheless, no Total Maximum Daily Load (T MDL) criteria have been developed for cyfluthrin or beta -cyfluthrin, based on information provided at http://iaspub.epa.gov/tmdl_waters10/attain s_nation.tm dl_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 thes e pesticides. 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/oppsrrd1/regist ration_review/water_quality_sop.htm ), in order to16 ensure they can be used quantitatively or qualitatively in pesticide risk assessments.

3. Stressor Source and Distribution

Cyfluthrin ( Tables 3.1a ) is a synthetic pyrethroid insecticide 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 cyfluthrin may be dictated by its ester moiety. It would be expected to hydrolyze as the pH increases; this is confir med from the hydrolysis study, where cyfluthrin was stable at pH 5, nearly stable at pH 7 and s howed a half-life of 2.1 days at pH 9. The structure of the molecule has three chiral centers that could result in a total of 2 3 or 8 isomers. Cyfluthrin has 2,2-di chloroethenyl and it is 2,2-dimethyl substituted in the cyclopropane ring.

Beta -cyfluthrin ( Tables 3.1a ) is a mixture of four of the isomers of cyfluthrin. Chemically, it is the (R)-alcohol-(1S)- cis -acid, (R)-alcohol-(1S)- trans -acid, (S)-alcohol- (1R)- cis -acid and (S)-alcohol-(1R)- trans -acid out of eight isomeric esters.

In general, the physicochemical and environm ental fate properties of cyfluthrin and beta

cyfluthrin are expected to be similar to each other. Information about the identification of cyfluthrin and beta -cyfluthrin is provided in Table 3.1a . A summary of physicochemical properties of cyfluthrin and beta -cyfluthrin is included in Table 3.1b

.17 Table 3.1a. Identification information for cyfluthrin and beta -cyfluthrin

CHEMICAL CYFLUTHRIN BETA -CYFLUTHRIN

PARAMETER VALUE(S) (units) SOURCE VALUE(S) (units) SOURCE

CAS Chemical Name cyano(4-fluoro-3- phenoxyphenyl)methyl 3-(2,2- dichloroethenyl)-2,2- dimethylcyclopropanecarboxylate Cyfluthrin data sheet, at: http://www.alanwood.net/pestic ides/cyfluthrin.html (accessed 04/21/10) cyano(4-fluoro-3- phenoxyphenyl)methyl 3-(2,2- dichloroethenyl)-2,2- dimethylcyclopropanecarboxylate Beta -cyfluthrin data sheet, at: http://www.alanwood.net/pestic ides/ beta -cyfluthrin.html

(accessed 04/21/10)

PC Code 128831 OPP Databases 118831 OPP Databases

IUPAC Chemical Name ( RS

)- α -cyano-4-fluoro-3-

phenoxybenzyl (1 RS ,3 RS ;1 RS ,3 SR )-3-(2,2- dichlorovinyl)-2,2- dimethylcyclopropanecarboxylate

or ( RS

)- α -cyano-4-fluoro-3- phenoxybenzyl (1 RS )- cis-trans -3- (2,2-dichlorovinyl)-2,2- dimethylcyclopropanecarboxylate Cyfluthrin data sheet, at: http://www.alanwood.net/pestic ides/cyfluthrin.html reaction mixture comprising the enantiomeric pair ( R )- α -cyano-4- fluoro-3-phenoxybenzyl (1 S ,3 S )-3- (2,2-dichlorovinyl)-2,2- dimethylcyclopropanecarboxylate

and ( S )- α -cyano-4-fluoro-3- phenoxybenzyl (1 R ,3 R )-3-(2,2- dichlorovinyl)-2,2- dimethylcyclopropanecarboxylate in ratio 1:2 with the enantiomeric pair ( R )- α -cyano-4-fluoro-3- phenoxybenzyl (1 S ,3 R )-3-(2,2- dichlorovinyl)-2,2- dimethylcyclopropanecarboxylate

and ( S )- α -cyano-4-fluoro-3- phenoxybenzyl (1 R ,3 S )-3-(2,2- dichlorovinyl)-2,2- dimethylcyclopropanecarboxylate

or reaction mixture comprising the enantiomeric pair ( R )- α -cyano-4- fluoro-3-phenoxybenzyl (1 S )- cis -3- (2,2-dichlorovinyl)-2,2- dimethylcyclopropanecarboxylate

and ( S )- α -cyano-4-fluoro-3- phenoxybenzyl (1 R )- cis -3-(2,2- dichlorovinyl)-2,2- dimethylcyclopropanecarboxylate in ratio 1:2 with the enantiomeric pair ( R )- α -cyano-4-fluoro-3- phenoxybenzyl (1 S )- trans -3-(2,2- dichlorovinyl)-2,2- dimethylcyclopropanecarboxylate

and ( S )- α -cyano-4-fluoro-3- phenoxybenzyl (1 R )- trans -3-(2,2- dichlorovinyl)-2,2- dimethylcyclopropanecarboxylate Beta -cyfluthrin data sheet, at: http://www.alanwood.net/pestic ides/ beta -cyfluthrin.html18 Table 3.1a. Identification information for cyfluthrin and beta -cyfluthrin

CHEMICAL CYFLUTHRIN BETA -CYFLUTHRIN

PARAMETER VALUE(S) (units) SOURCE VALUE(S) (units) SOURCE

Chemical Structure

(from chemical’s data sheet)

Unstated stereochemistry;
It consists of 8 isomers19 Table 3.1b. Summary of physicochemic al properties of cyfluthrin and beta -cyfluthrin

PARAMETER VALUE(S) (units) SOURCES

CAS Reg. No. 68359-37-5 (unstated stereochemistry) Cyfluthrin is a mixture of all possible isomers. 86560-92-1 (diastereoisomer I) 86560-93-2 (diastereoisomer II) 86560-94-3 (diastereoisomer III) 86560-95-4 (diastereoisomer IV) Beta -cyfluthrin is comprised mainly of diastereoisomers II and IV. FAO/WHO Specifications 1 and Cyfluthrin (157)/ Beta

cyfluthrin (228), Draft Review Prepared by Australian Quarantine and Inspection Service 2

Stereochemistry Diastereoisomer I: (1 R ,3 R ,1 R + 1 S ,3 S ,1 S = 1:1; cis ) Diastereoisomer II: (1 R ,3 R ,1 S + 1 S ,3 S ,1 R = 1:1; cis ) Diastereoisomer III: (1 R ,3 S ,1 R + 1 S ,3 R ,1 S = 1:1; trans ) Diastereoisomer IV: (1 R ,3 S ,1 S + 1 S ,3 R ,1 R = 1:1; trans ) FAO/WHO Specifications

Composition Diastereoisomer Cyfluthrin Beta -cyfluthrin I 23-27% ≤ 2.0% II 17-21% 30.0-40.0 III 32-36% ≤ 3.0% IV 21-25% 57.0-67.0 FAO/WHO Specifications

Molecular Formula C 22 H 18 Cl 2 FNO 3 Cyfluthrin’s data sheet

Molecular Weight 434.29 TOXNET/ HSDB 3

Melting Point 60oC; 64.40 diastereoisomer I; 80. 71 diastereoisomer II; 65.04 diastereoisomer III; 106.19 diastereoisomer IV TOXNET/ HSDB FAO/WHO Specifications

Boiling Point ( o C) Not measurable; weight loss above 160°C; decomposition >220°C FAO/WHO Specifications

pKa (20 o C) NA; Dissociation characteristic s: cyfluthrin does not show basic or acidic characteristics in water EC Review Report for the Active Substance Cyfluthrin and Beta -cyfluthrin 4

Solubility ( 20 o C) 2.32 x 10 -3 mg/L or ppm or 2.32 ppb at 20 o C pH 3/pH 5: 2.5/2.2 ug/L diast. I; 2.1/1.9 ug/L diast. II; 3.2/2.2 ug/L diast. III; 4.3/2.9 ug/L diast. IV* *The material used was a defined mixture of four diastereoisomeric enantiomer pairs. ‘Not Soluble’ Bolded value is considered representative for cyfluthrin. Laskowski 2002, FAO/WHO Specifications FAO, 2000

Vapor Pressure (20-25 o C) 1.5 x 10 -8 mmHg at 25°C 2.1 x 10 -9 mmHg at 20°C @20°C 9.6 x 10 -7 Pa diast. I 1.4 x 10 -8 Pa diast II 2.1 x 10 -8 Pa diast. III 8.5 x 10 -8 Pa diast. IV @25°C 2.1 x 10 -6 Pa diast. I 3.4 x 10 -7 Pa diast II 4.7 x 10 -7 Pa diast. III 2.0 x 10 -7 Pa diast. IV ‘Non-volatile under field conditions’ ( ≤ 9.98 x 10 -7 mmHg) Laskowski 2002 FAO/WHO Specifications USEPA, 2008

1 http://www.fao.org/ag/AGP/AGPP/Pestic id/Specs/docs/Pdf/new/cyfluthr.pdf and http://www.fao.org/ag/AGP/AGPP/Pestic id/Specs/docs/Pdf/new/beta_cyf.pdf (accessed 05/05/10).
2 http://www.fao.org/fileadmin/templates/agphome/documents/Pests_Pesticides/JMPR/Evaluation07/Cyflutr hin.pdf (accessed 05/05/10).
3 http://toxnet.nlm.nih.gov/

. 4 http://ec.europa.eu/food/plant/protection/evaluation/existactive/list1-29_en.pdf and http://ec.europa.eu/food/plant/protection/evaluation/existactive/list1-32_en.pdf (accessed 05/05/10).20 Table 3.1b. Summary of physicochemic al properties of cyfluthrin and beta -cyfluthrin

PARAMETER VALUE(S) (units) SOURCES

Henry’s Law Constant 3.7 x 10 -6 atm-m 3 /mol (estimated from vapor pressure at 25°C and water solubility at 20°) Laskowski, 2002

Octanol-Water Partition Coefficient (20 and 22°C) K OW (log K OW ) 9.33 x 10 5 (5.97)* 6.00 diast. I; 5.94 di ast. II; 6.04 diast. III; 5.91 diast. IV* 6.18 diast. II; 6.18 diast IV at 22°C *The material used was a defined mixture of four diastereoisomeric enantiomer pairs. Laskowski, 2002 FAO/WHO Specifications

Octanol-Air Partition Coefficient K OA (log K OA ) Constant Law sHenry' RTK
K K K OW

AW OW OA  = 6.17 x 10 9 (9.79)

Calculated using K OW = 9.33 x 10 5 and HLC = 3.7 x 10 -6

atm-m 3 /mol; the temperature was assumed to be 25°C. EPIWEB est.: 1.47 x 10 10 – 7.52 x 10 11 (10.164-11.876) Calculated Value EPIWEB v.4.0 Estimate

K AW (log K AW ) K AW = C air /C water = HLC/RT = 1.51 x 10 -4 (-3.82) EPIWEB estimate: K AW = 1.18 x 10 -6 (-5.926) ‘Slightly volatile from a water surface’ Calculated EPIWEB v.4.0 USEPA, 2008

C water /C air      

 

 6 air water 10GMW P 760RT S
C C = 6,612 (unitless)

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

OH Radical Reaction Half-life 0.856 days (Assumptions: 12-hr days; 1.5 x 10 6 OH/cm 3 ) EPIWEB 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 cyfluthrin, log K OA > 5, log K OW > 2. However, its rate

of transformation is moderate in the environment and appears to be moderately rapid in fish, with moderate to

rapid depuration indicated. Therefore, it appears that cyfluthrin may have a low 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.

Bolded value is considered representative for cyfluthrin.

Cyfluthrin has a high molecular weight of 434.29 g/mol. It also has a small solubility (only 2.32 ppb) and a high octanol/ water partition coefficient (K OW = 9.33x10 5 ). Based on its octanol/ water partition coefficient, it appears that cyfluthrinhas the potential to bioaccumulate/ bioconcentrate (K OW ≥ 1000) in fish and other aquatic organisms. With a vapor pressure of 1.5 x 10 -8 mmHg, it is considered “non-vol atile under field conditions.” Due to its very small solubility (2.32 ppb) , its calculated Henry’s Law Constant is moderately low (3.7 x 10 -6 atm-m 3 /mol). In addition, its C water /C air is 6612, which classifies it as “slightly volatile from a water surface” (USEPA 2008). Cyfluthrin could have a potential to volatilize slightly from wet surfaces. The potential to volatilize may be greatly attenuated in the environment by its tendency to bind to organic matter ( e.g. , soils, sediments, or organic matter and particul ate in natural water). For cyfluthrin, the log K OA range is 9.79 – 11.88 (calculated and EPIWEB v.4.0 estimates), the log K OW is 5.97 and the rate of transformation is modera te in the environment and appears to be moderate in fish (the majority of the residues observed in fish were the parent compound), with moderately rapid depur ation (observed depuration DT50 of approximately 3 days). Therefore, it appears that cyfluthrin may have a low potential to biomagnify substantially in terrestrial food chains, base d on the presumption made by Gobas et al. and Armitage & Gobas, in 2003 and 2007 articles, respectively.21 Nevertheless, the possibility of biomagnifi cation has not been qua ntified. Even though EFED has not adopted an official reference or guideline to disti nguish chemicals that biomagnify, Gobas et al. and Armitage & Gobas’ presum ption was utilized here as a general or broad reference to detect the poten tial for biomagnificati on in terrestrial food chains for these chemicals.

Even though various degradates were observed in the laboratory studies ( e.g. FPB-acid and DCVA), it was found that they were the re sult of the rupture of the ester bond of the parent molecule. It is believed that the toxici ty of the resulting molecules is substantially reduced compared to the parent because they presumably have lost the neurotoxic mode of action. Table 3.1c shows the chemical structures of cyfluthrin’s major degradation products. At this time, they are not consid ered stressors of concern in this problem formulation. As part of the forthcoming ri sk assessment, available information on the toxicity of these degradat es will be considered to confirm this assumption.

Table 3.1c. Major Transformation Products of Cyfluthrin and Beta -cyfluthrin

Common

Name Chemical Name Structure

DCVA 3-(2,2-dichlorovinyl)-2,2- dimethyl-cyclopropanecarboxylic
acid Cl

Cl O

OH

CH

3 CH 3

FPB-ald 4-fluoro-3-phenoxybenzaldehyde

or 3-phenoxy-4-fluorobenzaldehyde
O F

O

FPB-acid 4-fluoro-3-phenoxybenzoic acid

or 3-phenoxy-4-fluorobenzoic acid O F

O

OH

3.1. Mechanism of Action

Both, cyfluthrin and beta -cyfluthrin are neural toxic in secticides acting through direct contact and ingestion. The inse cticidal effect of pyrethroids is characterized by a rapid “knock down,” or paralysis, of insects. A ll pyrethroids act as a xonic poisons, affecting both the peripheral and central nervous system s, and share similar modes of action. The primary biological eff ects of cyfluthrin, beta -cyfluthrin and other pyrethroids on insects and vertebrates reflect an inhibition of the correct firing of neurotransmitter deliver signals from one cell to another via nerve me mbrane inhibition of the voltage-gated Ca 2+22 (calcium ion) channels coupled with a stimulatory effect on the voltage-gated Na + (sodium ion) channels. The pyrethr oids (including cyfluthrin and beta -cyfluthrin) share similar modes of action, and are considered a xonic poisons that affect both the peripheral and central nervous system.

It is now well established that severe neurological symptoms of poisoning with pyrethroids in mammals a nd insects are the result of modification of the Na + channels activity (cellular 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 l ong as several seconds. This modification of Na + channel properties leads to hyperactivity of the nervous system. This action leads to spontaneous depolarizations, augmented neurotransmitter secretion rate and neuromuscular block, which ultimately re sults 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. , cypermethrin, deltamethrin, fenvalerate, cyfluthrin and beta -cyfluthrin). Type I pyrethroids action is mainly asso ciated with compounds that cause nerve excitation symptoms typified by the appearan ce of repetitive firing of axons in the peripheral nervous system and a negatively co rrelated temperature reversible knockdown property (Clark & Matsumura, 1987). In inse cts, the type II pyrethroids predominantly cause ataxia and uncoordinated movement.

3.2. Overview of Pesticide Usage

Cyfluthrin and beta -cyfluthrin have numerous uses. A summary of agricultural use patterns for cyfluthrin and beta -cyfluthrin, based on a set of labels for cyfluthrin and all labels for beta -cyfluthrin, are shown Tables 3.2a and 3.2b

.

Table 3.2a. Summary use information for cyfluthrin based on BAYTHROID® 2 Emulsifiable Pyrethroid Insecticide (Reg. No. 264-745), RENO UNCE® 20WP Insecticide (Reg. No. 264-784) and LEVERAGE® 2.7 Suspension Emulsion Insecticide (Reg. No. 264-770) labels. For use on corn, labels with Reg. Nos. 264-811, 264-812, 264-813 and 264-839 were also evaluated.

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

Corn (field corn, popcorn, seed corn, teosinte) – foliar applications or Corn – soil applications at plant or Corn – soil applications at plant – granular formulation 0.044

0.044 0.0073 4

1 0.175 7 G, A, ULV, Soil Applications Grain and fodder – 21; green forage – 0

Sweet Corn (Folia rApplications)/ (Soil Application – one application allowed) 0.044 10 0.44 2 G, A, ULV 0

Cotton 0.05 10 0.5 3 G, A, ULV 0 Peanut 0.044 3 0.131 10 G, A, ULV 1423 Table 3.2a. Summary use information for cyfluthrin based on BAYTHROID® 2 Emulsifiable Pyrethroid Insecticide (Reg. No. 264-745), RENO UNCE® 20WP Insecticide (Reg. No. 264-784) and LEVERAGE® 2.7 Suspension Emulsion Insecticide (Reg. No. 264-770) labels. For use on corn, labels with Reg. Nos. 264-811, 264-812, 264-813 and 264-839 were also evaluated.

USE SINGLE APP. RATE (lbs. a.i./A) NUMBER OF APPS. SEASONAL APP. RATE (lbs. a.i./A) INTERVAL BETWEEN APPS. (days) APPLIC. METHOD PHI (days) Sorghum 0.044 3 0.131 10 G, A, ULV 14 Soybean 0.044 4 0.175 7 G, A, ULV 45 Sugarcane 0.044 6 0.263 7 G, A, ULV 15 Sunflower 0.044 3 0.131 7 G, A 30 Tobacco 0.0044 1 0.0044 N/A G Apply up to 7 days following transplanting Wheat 0.038 2 0.076 3 G, A, ULV 30 Brassica (Cole) Leafy Vegetables: broccoli, broccoli raab (rapini), Chinese (gai lon) broccoli, Brussels sprouts, cabbage, Chinese (bok choy) cabbage, Chinese (napa) cabbage, Chinese mustard (gai choi) cabbage, cauliflower, cavalo broccoli, collards, kale, kohlrabi, mizuna, mustard greens, mustard spinach, rape greens, and turnip greens 0.05 4 0.2 7 G, A 0

Cucurbits: balsam apple, balsam pear, bitter melon, chayote, Chinese cucumber, Chinese waxgourd, citron melon, cucumber, gherkin, edible gourd (includes various), muskmelon (includes cantaloupe, honeydew melon and others), pumpkin, summer squash (includes zucchini and others), watermelon, Winter squash (includes calabaza, and others) 0.044 4 0.175 7 G, A 0

Fruiting Vegetables: eggplant, groundcherry, pepino, pe pper (includes bell pepper, chilipepper, cooking pepper, pimento, sweet pepper), tomatillo, tomato 0.044 6 0.263 7 G, A 0 for tomato and 7 for other

crops Leafy Vegetables: amaranth, arugula, cardoon, celery, Chinese celery, celtuce, chervil, Chrysanthemum, corn salad, cress, dandelion, dock, endive, Florence fennel, lettuce (head and leaf), New Zealand spinach, orach, parsley, purslane, radicchio, rhubarb, spinach, Swiss chard, vine spinach 0.05 4 0.2 7 G, A 0

Dried Shelled Le gume Vegetables: adzuki beans, blackey ed pea, broad bean, catjan, chickpea, cowpea, crowder pea, field bean, field pea, guar, kidney bean, lablab bean, lentil, dry lima bean, lupin (various), moth bean, mung bean, navy bean, pigeon pea, pinto bean, rice bean, tepary bean, urd bean 0.05 2 0.1 14 G, A 7

Southern Pea 0.033 5 0.165 5 G, A 3 Potato and Other Tuberous and Corm Vegetables: arracacha, arrowroot, artichoke, edible canna, cassava, chayote root, chufa, dasheen, ginger, leren, potato, sweet potato, tanier, true yam, turmeric, yam bean 0.044 6 0.263 5 G, A 024 Table 3.2a. Summary use information for cyfluthrin based on BAYTHROID® 2 Emulsifiable Pyrethroid Insecticide (Reg. No. 264-745), RENO UNCE® 20WP Insecticide (Reg. No. 264-784) and LEVERAGE® 2.7 Suspension Emulsion Insecticide (Reg. No. 264-770) labels. For use on corn, labels with Reg. Nos. 264-811, 264-812, 264-813 and 264-839 were also evaluated.

USE SINGLE APP. RATE (lbs. a.i./A) NUMBER OF APPS. SEASONAL APP. RATE (lbs. a.i./A) INTERVAL BETWEEN APPS. (days) APPLIC. METHOD PHI (days) Root Vegetables (except sugarbeet): gardenbeet, edible burdock, carrot, celeriac, turnip-rooted chervil, chicory, ginseng, horseradish, turnip-rooted parsley, parsnip, radish, Oriental radish, rutabaga, salsify (various), skirret, turnip 0.044 5 0.22 7 G, A 0

Citrus** calamondin, citrus citron, citrus hybrids (includes chironja, tangelo), grapefruit, kumquat, lemon, lime, mandarin (tangerine), orange, pummelo, satsuma mandarin, white sapote and other cultivars and/or hybrids of these **California and Arizona, only. 0.1 1 0.1 N/A G, A 0

Grape: table grape, raisin, wine and muscadine grape (Product LEVERAGE® 2.7) 0.05

0.07 4 1 0.2

0.07 14 N/A G, A 3

Hop 0.05 5 0.25 14 G, A 7 Pome Fruit: apple, crabapple, loquat, mayhaw, pear, Oriental pear, quince 0.044 1 0.044 N/A G, A 7

Stone Fruit: apricot, cherry, nectarine, peach, plum, plumcot, prune (fresh and dried) 0.044 2 0.088 14 G, A 7

Tree Nut Crops: almond, beechnut, Brazil nut, butternut, cashew, chestnut, chinquapin, filbert, hickory nut, macadamia nut, pecan, pistachio, walnut (black and English) 0.044 1 0.044 N/A G, A 14

Alfalfa, alfalfa grown for seed 0.044, 0.088 per

cutting 8 0.35 5 G, A, ULV 7

Grass (pasture, rangeland, grass for seed, grass for hay, grass in mixed-stands with alfalfa) 0.044 per
app. 4 0.176 5 G, A, ULV Pregrazing interval:

0-7

Table 3.2b. Summary use information for beta -cyfluthrin , based on BAYTHROID® XL (Reg. No. 264-840), LEVERAGE® 360 Insecticide (Reg. No. 264-1104) and PONCHO BETA (Reg. No. 264-1056) labels.

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

Corn (field corn, popcorn, seed corn) ; Corn (soil applications) 0.022 4 0.088 7 G, A, ULV, Soil Applications Grain and fodder – 21; green forage – 0 Sweet Corn (Folia rApplications)/ (Soil Application – at plant) 0.022/ 0.022 10 0.44 2 G, A, ULV 0

Cotton 0.025 10 0.25 3 G, A, ULV 0 Peanut 0.022 3 0.066 10 G, A, ULV 14 Sorghum 0.022 3 0.066 10 G, A, ULV 1425 Table 3.2b. Summary use information for beta -cyfluthrin , based on BAYTHROID® XL (Reg. No. 264-840), LEVERAGE® 360 Insecticide (Reg. No. 264-1104) and PONCHO BETA (Reg. No. 264-1056) labels.

USE SINGLE APP. RATE (lbs. a.i./A) NUMBER OF APPS. SEASONAL APP. RATE (lbs. a.i./A) INTERVAL BETWEEN APPS. (days) APPLIC. METHOD PHI (days) Soybean 0.022 4 0.088 7 G, A, ULV 45 Sugarcane 0.022 6 0.132 7 G, A, ULV 15 Sunflower 0.022 3 0.066 7 G, A 30 Tobacco 0.0022 1 0.0022 N/A G Apply 7 days following transplanting Brassica (Cole) Leafy Vegetables: broccoli, broccoli raab (rapini), Chinese (gai lon) broccoli, Brussels sprouts, cabbage, Chinese (bok choy) cabbage, Chinese (napa) cabbage, Chinese mustard (gai choi) cabbage, cauliflower, cavalo broccoli, collards, kale, kohlrabi, mizuna, mustard greens, mustard spinach, rape greens, and turnip greens 0.025 4 0.1 7 G, A 0

Cucurbits: balsam apple, balsam pear, bitter melon, chayote, Chinese cucumber, Chinese waxgourd, citron melon, cucumber, gherkin, edible gourd (includes various), muskmelon (includes cantaloupe, honeydew melon and others), pumpkin, summer squash (includes zucchini and others), watermelon, Winter squash (includes butternut squash, calabaza, and others) 0.022 4 0.088 7 G, A 0

Fruiting Vegetables: eggplant, groundcherry, pepino, pepper (includes bellpepper, chilipepper, cooking pepper, pimento, sweet pepper), tomatillo, tomato 0.022 6 0.132 7 G, A 0

Leafy Vegetables: amaranth, arugula, cardoon, celery, Chinese celery, celtuce, chervil, Chrysanthemum, corn salad, cress, dandelion, dock, endive, Florence fennel, lettuce (head and leaf), New Zealand spinach, orach, parsley, purslane, radicchio, rhubarb, spinach, Swiss chard, vine spinach 0.025 4 0.1 7 G, A 0

Dried Shelled Le gume Vegetables: adzuki beans, blackey ed pea, broad bean, catjan, chickpea, cowpea, crowder pea, field bean, field pea, guar, kidney bean, lablab bean, lentil, dry lima bean, lupin (various), moth bean, mung bean, navy bean, pigeon pea, pinto bean, rice bean, tepary bean, urd bean 0.025 2 0.05 14 G, A 7

Southern Pea 0.017 5 0.083 5 G, A 3 Potato and Other Tuberous and Corm Vegetables: arracacha, arrowroot, artichoke, edible canna, cassava, chayote root, chufa, dasheen, ginger, leren, potato, sweet potato, tanier, true yam, turmeric, yam bean 0.022 6 0.132 5 G, A 0

Root Vegetables (except sugarbeet): garden beet, edible burdock, carrot, celeriac, turnip-rooted chervil, chicory, ginseng, horseradish, turnip-rooted parsley, parsnip, radish, Oriental radish, rutabaga, salsify (various), skirret, turnip 0.022 5 0.11 7 G, A 026 Table 3.2b. Summary use information for beta -cyfluthrin , based on BAYTHROID® XL (Reg. No. 264-840), LEVERAGE® 360 Insecticide (Reg. No. 264-1104) and PONCHO BETA (Reg. No. 264-1056) labels.

USE SINGLE APP. RATE (lbs. a.i./A) NUMBER OF APPS. SEASONAL APP. RATE (lbs. a.i./A) INTERVAL BETWEEN APPS. (days) APPLIC. METHOD PHI (days)
Citrus** calamondin, citrus citron, citrus hybrids (includes chironja, tangelo), grapefruit, kumquat, lemon, lime, mandarin (tangerine), orange, pummelo, satsuma mandarin, white sapote and other cultivars and/or hybrids of these **California and Arizona, only. 0.05 1 0.05 N/A G, A 0

Grape: table grape, raisin, wine and muscadine grape/ For the product LEVERAGE® 360 0.025

0.05 4

1 0.1

0.05 14 G, A 3

Hop 0.025 5 0.125 14 G, A 7 Pome Fruit: apple, crabapple, loquat, mayhaw, pear, Oriental pear, quince 0.022 1 0.022 N/A G, A 7

Stone Fruit: apricot, cherry, nectarine, peach, plum, plumcot, prune (fresh and dried) 0.022 2 0.044 14 G, A 7

Tree Nut Crops: almond, beechnut, Brazil nut, butternut, cashew, chestnut, chinquapin, filbert, hickory nut, macadamia nut, pecan, pistachio, walnut (black and English) 0.022 1 0.022 N/A G, A 14

Alfalfa 0.022 0.044 per

cutting 8 0.175 5 G, A, ULV 7

Grass (pasture, rangeland, grass for seed, grass for hay, grass in mixed-stands with alfalfa) 0.022/ app. 0.022/ cutting 4 0.089 5 G, A, ULV 0

Sugar beet, seed treatment ~0.0125 1 ~0.0125 N/A Seed Treatment N/A

As mentioned previously at the top of Tables 3.2a and 3.2b, there are several end use agricultural products cont aining cyfluthrin and beta -cufluthrin like BAYTHROID® XL (Reg. No. 264-840), BAYTHROID® 2 Emulsifiable Pyrethroid Insecticide (Reg. No. 264-745), RENOUNCE® 20WP Insecticide (Reg. No. 264-784) and PONCHO BETA (Reg. No. 264-1056)

. In general, for a given crop, the application rate for beta -cyfluthrin is around half that for cyfluthrin. For agricultural products, applicatio n methods include aerial or ground spray (foliar) and ULV. In additi on, soil applications are possible, particularly for corn. The labels for cyfluthrin and beta -cyfluthrin require a buffer zone of 10 ft around certain bodies of water, such as lakes, reservoirs, rivers, permanent streams, marshes or natural ponds, estuaries and commercial fish farm ponds, so as to allow growth of a maintained vegetative filter strip. Th e agricultural products shoul d not be applied by ground equipment within a distance of 25 ft, or by aerial equipment within a distance of 150 ft, or by ULV within a distance of 450 ft from fr eshwater or estuarine/ marine bodies of water ( e.g. lakes, reservoirs, rivers, permanen t streams, marshes or natural ponds, estuaries and commercial fish farm ponds).

For corn, granular formulations are available that may be applied as a band, T-band or in furrow applications, soil incor porated (it appears that the mi nimum incorporation depth is27 1 inch). The buffer zone is 60 ft from adjacent bodies of water. The granular formulations also contai n O-[2-(1,1-Dimethylethyl)-5-p yrimidinyl]-O-ethyl O-(1- methylethyl) phosphorothioate, an organophos phate insecticide, commonly named phostebupirim. Cyfluthrin and beta -cyfluthrin may be co-formulated with imidacloprid, in the products LEVERAGE® 2.7 Suspensi on Emulsifiable Insecticide and LEVERAGE® 360 Insecticide. For beta -cyfluthrin, the product PONCHO® BETA is coformulated with chlothianidin, for the use on sugar beet seeds.

The Label Use Information System (LUIS report) & Usage/Label Use Reports for cyfluthrin (provided by BE AD) was based on a partial listing of labels, due to the large number of labels available for review; use da ta is not based on an exhaustive review of the entire population of labels. Section 3 la bels or major producers’ labels, along with all State and Local Needs (SLNs) labels, are included in the LUIS report. These data represent the major uses of this chemical. For beta -cyfluthrin, all labels were included in the LUIS report.

The usage of cyfluthrin, from the Screening Le vel Usage Analysis (SLU A) is provided in Table 3.3 . The table is arranged in alphabetical order of crops. According to the table, the major agricultural uses for cyfluthri n, crops for which 5000 or more pounds active ingredient are applied, are alfalfa, corn, cotton, soybeans, potatoes, oranges and sweet corn. For cotton and corn, for wh ich the pounds applied are 60,000 and 30,000, respectively, the average percent crop treate d is 5, and maximum percent crop treated are moderately low (10-15%). The crop for which the percent crop treate d is the highest is potatoes, for which these percentages may r each moderately high values (25 and 35%, for the average and maximum, respectively).

Table 3.3. Screening-Level Estimates of Agri cultural Uses of Cyfluthrin (SLUA, dated 09/28/09). Percent Crop Treated Crop lbs a.i. Avg. Max.
Alfalfa 10,000 <2.5 5 Apples <500 <2.5 5

Artichokes <500 <1 <2.5
Beans, Green <500 <2.5 5

Broccoli <500 <2.5 <2.5 Cabbage <500 5 15 Cantaloupes <500 <2.5 <2.5

Carrots <500 10 25

Cauliflower <500 5 10 Celery <500 <2.5 <2.5

Cherries <500 <2.5 <2.5

Corn 30,000 5 10
Cotton 60,000 5 15

Cucumbers <500 <1 <2.528 Table 3.3. Screening-Level Estimates of Agri cultural Uses of Cyfluthrin (SLUA, dated 09/28/09). Percent Crop Treated Crop lbs a.i. Avg. Max. Dry Beans/Peas <500 <1 <2.5 Grapefruit <500 <2.5 5

Grapes <500 <1 <2.5 Hazelnuts (Filberts) <500 20 25

Lemons <500 5 15
Lettuce 1,000 5 10

Onions + <500 <1 <2.5 Oranges 5,000 5 15

Peaches <500 <1 <2.5
Peanuts 1,000 5 10

Pears <500 <2.5 <2.5

Pecans <500 <1 <2.5 Peppers 1,000 15 25

Pistachios <500 5 15
Potatoes 10,000 25 35 Pumpkins <500 <2.5 <2.5

Rice <500 <1 <2.5 Sod (NPUD '02) + <500 5 N/C Sorghum 2,000 <1 <2.5 Soybeans 7,000 <1 <2.5 Spinach <500 5 5 Squash <500 5 10 Sugarcane 1,000 <2.5 5 Sunflowers 1,000 <2.5 5

Sweet Corn 6,000 10 25

Tobacco <500 <1 <2.5
Tomatoes 2,000 5 10

Watermelons <500 <1 <2.5 Wheat 2,000 <1 <2.5 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. ‘+’ Crops 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 America Foundation and California Department of Pesticide Regulation (CDPR) data. Th e information reflects amalgamated data developed by the Agency and are in a releasable format.

There is no similar SLUA for beta -cyfluthrin. According to the LUIS report, no usage29 data was found for this chemical (as of January 2010).

The U.S. Geological Survey (USGS) pesticide agricultural use maps ( Fig. 3.1 ) show regional scale patterns in use intensity w ithin the United States. The USGS pesticide maps are based on State level estimates of pe sticide use rates for i ndividual 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 map, the major agricu ltural use for cyfluthrin is cotton with 46.96% of the use, followed by corn, alfalf a hay and potatoes with 6.72-19.41% of the use. Other crops with >1% of the use in cluded sweet corn, citr us fruits, tomatoes, sorghum and lettuce. One crop, with reported percent of the use <1% is sunflower seed. As expected, there is a general agreemen t between the SLUA and the USGS map. The map shows a generalized use of cyfluthrin for agricultural pur poses throughout the country, with highest uses in th e cornbelt and the cotton belt. It also shows potential uses in estuarine/ marine regions of the US. Multiple agricultural uses are approved for cyfluthrin, other than the ones in the map, as indicated above in the Table 3.2a

. At the present time, there is no similar agricultural map for beta -cyfluthrin.30 Fig. 3.1. Estimated Use of Cyfluthrin 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 agricu ltural use sites, cyfluthrin and beta -cyfluthrin have multiple other uses. Cyfluthrin and beta -cyfluthrin may be used in multiple urban environments. Many of these uses are cl assified as outdoor re sidential such as ornamental lawns and turf, recreation area la wns, ornamental and/ or shade trees, ornamental herbaceous plants, ornamental woo dy shrubs and vines, paths/ patios, paved areas (private roads/ sidewalk s), pet living/ sleeping quarter s, and residential lawns. Tables 3.4a and 3.4b provide a summary of the terrest rial nonagricultural use sites for cyfluthrin and beta -cyfluthrin, respectively. Applica tion methods vary. Many of these uses could involve substantive exposure to wi ldlife, specifically, aquatic organisms, and31 they will be assessed accordingly ( e.g. , commercial/ industrial la wns, residential lawn, golf course turf, ornamental lawns and turf, re creation areas and reside ntial lawns). (Note that there are fewer non-food uses for beta -cyfluthrin than for cyfl uthrin.) Another use that will be evaluated is wood protection treatment (outdoors).

Table 3.4a. Uses Classified as Terrestrial Non-Food or Outdoor for Cyfluthrin

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

Year Min. App. Int./ days agricultural/farm structures/buildings and equipment 0.0044 lb 1K sq.ft NS NS NS

airports/landing fields 0.0100 lb 1K sq ft 0.0042 lb/ mound NS NS AN, NS animal kennels/sleeping quarters 0.0100 lb 1K sq ft NS NS AN animals (laboratory/research) 0.0100 lb 1K sq ft NS NS 7 automobiles, taxis, limousines, recreational ve hicles, & tires 0.0100 lb 1K sq ft NS NS 7 barns/barnyards/auction barns 0.0085 lb 1K sq ft NS NS 10, NS commercial storages/warehouses premises 0.0100 lb 1K sq ft NS NS AN, 7 commercial/industrial lawns 0.0100 lb 1K sq ft NS NS 7, AN commercial/institutional/industrial premises/equipmen t (outdoor) 0.0100 lb 1K sq ft NS NS 7, AN golf course turf 0.0031 lb 1K sq ft 6/ 1 yr NS NS greenhouse-empty 0.0100 lb 1K sq ft NS NS 7

household/domestic dwellings outdoor premises 0.0088 lb 1K sq ft 0.0042 lb/ mound 6/ 1 yr NS 7, AN, NS

industrial areas (outdoor) 0.0088 lb 1K sq ft 0.0042 lb/ mound NS NS 7, NS livestock feed lots 4.579E-06 lb/ sq ft NS NS AN meat processing plant premises (nonfood c ontact) 0.0100 lb 1K sq ft NS NS 7

nonagricultural outdoor buildings/structures 0.0100 lb 1K sq ft 0.0042 lb/ mound NS NS NS, AN, 7 nonagricultural rights-of-way/fencerows/hedgero ws 0.0100 lb 1K sq ft NS NS 7, 30, AN ornamental and/or shade trees 0.0100 lb 1K sq ft NS NS AN, 7, 30 ornamental ground cover 0.0040 lb 1K sq ft NS NS 7, 30 ornamental herbaceous plants 0.0040 lb 1K sq ft NS NS AN, 7, 30 ornamental lawns and turf 0.0100 lb 1K sq ft 6/ 1 yr, NS NS AN, 7, NS ornamental nonflowering plants 0.0100 lb 1K sq ft 6/ 1 yr, NS NS AN, 7, 30, NS ornamental woody shrubs and vines 0.0040 lb 1K sq ft 6/ 1 yr, NS NS AN, 7, 30, NS

paths/patios 0.0100 lb 1K sq ft 0.0042 lb/ mound NS NS NS, 7, AN

paved areas (private roads/sidewalks) 0.0088 lb 1K sq ft 0.0042 lb/ mound NS NS 7, NS pet living/sleeping quarters 0.0100 lb 1K sq ft NS NS 7, AN recreation area lawns 0.0044 lb 1K sq ft 6/ 1 yr, NS NS 7, NS recreational areas 0.0088 lb 1K sq ft NS NS 7, NS residential lawns 0.0042 lb 1K sq ft 6/ 1 yr, NS NS NS

tobacco 0.0044 lb/A 1 0.0044 lb/A/cc 7

wood protection treatment to buildings/products outdoor 0.0085 lb 1K sq ft 0.0011 lb sq ft NS NS NS wood protection treatment to forest products (unseasoned) 0.0088 lb 1K sq ft NS NS 7

zoos 0.0100 lb 1K sq ft NS NS 7, AN NS = Not Specified; AN = As Needed; cc = crop cycle. Data obtained from LUIS Report.

Table 3.4b. Uses Classified as Non-Food or Outdoor for Beta -cyfluthrin

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

Year Min. App. Int./ days agricultural/farm premises 0.0042 lb 1K sq ft NS NS NS, 10 barns/barnyards/auction barns 0. 0042 lb 1K sq ft NS NS NS Christmas tree plantations 0.025 lb/A NS 0.125 lb/cc AN commercial/industrial lawns 0.0022 lb 1K sq ft 6/ 1 yr NS AN commercial/institutional/industrial premises/equipmen t (outdoor) 0.0044 lb 1K sq ft NS NS NS, 7 fencerows/hedgerows 0.0044 lb 1K sq ft NS NS NS, 732 Table 3.4b. Uses Classified as Non-Food or Outdoor for Beta -cyfluthrin

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

Year Min. App. Int./ days household/domestic dwellings outdoor premises 0.0042 lb 1K sq ft NS NS NS, 7

ornamental and/or shade trees 0.0015 lb 1K sq ft NS NS NS, 7, 14, 30, AN ornamental ground cover 0.0015 lb 1K sq ft NS NS NS, 7 ornamental herbaceous plants 0.0015 lb 1K sq ft NS NS NS, 7, 14, AN ornamental lawns and turf 0.0022 lb 1K sq ft 6/ 1 yr NS NS, AN ornamental nonflowering plants 0.0015 lb 1K sq ft NS NS NS, 7, 14 ornamental woody shrubs and vines 0. 0015 lb 1K sq ft NS NS NS, 7, 14 paths/patios 0.0044 lb 1K sq ft NS NS NS, 7

paved areas (private roads/sidewalks) Not specified, RTU formulation NS NS NS recreation area lawns 0.0022 lb 1K sq ft 6/ 1 yr NS AN residential lawns 0.0022 lb 1K sq ft 6/ 1 yr, NS NS 7, NS, AN tobacco 0.0022 lb/A 1/ cc 0.0022 lb/ cc NS

wood protection treatment to buildings/products outdoor NS, various formulations NS NS 7, NS NS = Not Specified; AN = As Needed; cc = crop cycle. Data obtained from LUIS Report.
In addition, there are several other indoor non-food or indoor re sidential use sites for both cyfluthrin and beta -cyfluthrin, like for example, commercial/institutional/industrial premises/equipment (indoor), dairies/cheese processing plant premises (nonfood contact), eating establishments, food processing plan t premises (nonfood c ontact), food stores/ markets/ supermarkets premises, hospitals/ medical institutions premises and household/ domestic dwellings. Cyfluthrin and beta -cyfluthrin also have greenhouse uses.

For the indoor uses, the Division has conducte d environmental risk assessments for a few chemicals for Re-registration Eligibility Deci sions. In an open literature study (Weston and Lydy 2010), several synthetic pyrethroids we re observed in effluents after secondary treatment from POTWs in the Sacramento-San Joaquin Delta. In the study, bifenthrin was the most frequently detected pyrethr oid. Cyfluthrin was found in 6% of the municipal wastewater treatment plant efflue nts (POTWs) tested in the Sacramento-San Joaquin Delta (18 samples), at a maximum c oncentration of 1.7 ng/L, and it exceeded the Hyalella azteca EC 50 of 1.9 ng/L in 0% of the samples. This study indicates there is a potential for synthetic pyrethroids to reach surface waters via exposure from contaminated drains, and even af ter treatment in plants (for further information about this study, see Section 3.4 ). The EFED will evaluate the potential for exposure to aquatic organisms from the various indoor uses of cyfluthrin and beta -cyfluthrin (see also further information below).

Toxicity data on environmental mixtures of cyfluthrin or beta -cyfluthrin with other pesticides may be presented, if available, as part of the ecological risk assessment. It is expected that the toxic ef fect of cyfluthrin or beta -cyfluthrin, in combination with other pesticides used in the environment, is likel y to be a function of many factors including but not necessarily limited to: (1) the expos ed species, (2) the co -contaminants in the mixture, (3) the ratio of cyfluthrin or beta -cyfluthrin and co-contaminant concentrations, (4) differences in the pattern and duration of exposure among cont aminants, and (5) the differential effects of other phys ical/ chemical characteristic s of the receiving waters ( e.g. organic matter present in sediment and susp ended water). Quantitatively predicting the33 combined effects of all these variables on mixture toxicity to any given taxa with confidence is beyond the capabilities of the av ailable data and methodologies. However, a qualitative discussion of implications of the available pesticide mixture effects data regarding the confidence of risk assessment conclusions wi ll be addressed as part of the uncertainty analysis.

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

A total of 4 current product registrations ex ist for cyfluthrin formulations with PBO:

 Cyfluthrin, PBO and Pyrethri ns: # 279-3404, #499-462, #9444-183, #9444-226

Beta -cyfluthrin is not co-formulated with PBO or MGK in any currently active registrations.

The Agency routinely assesse s potential exposure to form ulations by examining acute exposure due to spray drift or direct applications to wate r and comparing the estimated exposure to available acute to xicity data on the formulati on. The spray drift associated with the cyfluthrin uses cont aining synergists will be minimal, as all cyfluthrin products with PBO or MGK are register ed for residential or struct ural uses only. Therefore, a quantitative assessment of the potential aqua tic exposure to the formulation containing MGK synergists will not be conducted. Pipe ronyl butoxide and/or MGK-264 from other pyrethroid applications ( e.g. the application of an adul ticide containi ng PBO), could interact with cyfluthrin and beta -cyfluthrin in the environmen t. Available literature data also suggest the potential for syne rgism in the environment (Amweg et al. 2006, Weston et al. 2006, Amweg & Weston 2007, and Brander et al. 2009). Therefore, potential interactions will be discussed qualitatively in the risk assessment. EPA is currently evaluating options on how to gather data on pyrethroid end use pr oducts co-formulated with a synergist.

It is important to recognize that the active i ngredient and the synergist have differing fate properties and therefore would be expected to occur in the en vironment at different times and at different concentrations than present in the end use product. Consequently, it is necessary to have toxicology da ta which allows the assessment of the level of synergy as the ratio of the pesticide and s ynergist vary in the environment. Datasets which allow the calculation of the ‘pesticide-synergist intera ction’ are often not available. EFED recognizes the limitations inherent in this appr oach and is looking into the acquisition of data that would allow the eval uation of the effect of both s ynergist and active ingredient when present in the ecosystem. Evaluating th e potential toxic effects of the synergist include evaluating ecological e ffects data generated using en d-use products and the active ingredient in the presence of synergists, in addition to data for the active ingredient alone.34 At this time, EFED typically has data for indi vidual active ingredients, as well as for the synergists alone, but few data are available fr om which to draw conclusions regarding the potential effect of the combination. As stat ed above, the Agency is evaluating its options for obtaining data appropriate fo r this type of evaluation.

3.3. Environmental Fate and Transport

The m ajority of the environmental fate stud ies for these chemical s were conducted with cyfluthrin, which comprises all eight isomer s. The environmental fate properties of cyfluthrin and beta -cyfluthrin are expected to be si milar to each other. [Phenyl- 14 C]- radiolabeled compound was utilized in most instances.

A summary of environmental fate/ tran sport properties for cyfluthrin and beta -cyfluthrin is included in Table 3.5

.35 Table 3.5. Summary of the environmental fate and transport properties of cyfluthrin and beta -cyfluthrin.

PARAMETER VALUE(S) (units) SOURCE COMMENT
Hydrolysis Half-life [pH 5, 7, 9; (25 o C)] Stable at pH 5, nearly stable at pH 7,
t 1/2 = 2.1 days at pH 9; major degradation product FPB-ald MRID: 00131493, 00137539, 45022101 Supplemental data shows that the half-life was 9 days in natural waters from the Rhine river. Major product was FPB-acid. Water’s pH was 7.7-8.3. Aqueous Photolysis Half-life (pH 5) t 1/2 = 4.5 days linear;
t 1/2 = 0.7 days nonlinear;

degradation products: FPB-acid and FPB-ald MRID: 00149595, 45022102 Value obtained using natural sunlight

Soil Photolysis Half-life t 1/2 = 5.6 days; degradation product: FPB-ald MRID: 00137543, 00157043 Dark control corrected; using natural sunlightAerobic Soil Metabolism Halflife L t 1/2 = 73.5 days SL t 1/2 = 94.8 days major degradate: FPB-acid MRID: 00131494 –

Anaerobic Soil Metabolism Half-life t 1/2 ~ 30 days; degradate FPB-acid declined MRID: 00131494 Study lasted 60 days.

Aerobic Aquatic Metabolism Half-life t 1/2 = 32.9 and 42.0 days for two German systems. Degradates DCVA, FPB-acid and FPB-ald MRID: 46824101 (20.4 & 22.0 days for two Dutch systems, but the quality of these half-lives was cons idered very low.) Anaerobic Aquatic Metabolism Half-life No Study Available NA Study is required.

Soil Partition Coefficient (K d ) Organic Carbon Partition Coefficient (K OC ) For Cyfluthrin Adsorption: Soil K d K OC German LS 1116 124000 US LS 1244 180300 US CL 1321 118000 German SiL 1793 73500 Desorption: Soil K d K OC German LS 1448 161000 US LS 974 141000 US CL 1307 117000 German SiL 1705 69900

K OC in mL/g OC and K d in mL/g.

Immobile to hardly mobile. There is a linear relationship between the soil organic carbon content and the K d values (r 2 = 0.92). MRID: 00131495, 00137544, 45022103 In supplemental studies, TLC data for cyfluthrin on six different soils were submitted. Using the Helling and Turner mobility classification system, cyfluthrin was classified as

immobile in the six test soils. To help EFED develop a K d input for

modeling, the registrant later submitted a supplemental study to

the Agency which contained a single K d value for one soil of 810 mL/g.

Soil Partition Coefficient (K d ) Organic Carbon Partition Coefficient (K OC ) For trans -DCVA Adsorption: Soil K F K FOC Sand ND ND Silty Clay 0.46 18 Sandy Loam 0.16 19 Sandy Loam 0.54 48 Desorption: Soil K F K FOC Sand ND ND Silty Clay 0.91 36 Sandy Loam 0.36 44 Sandy Loam 0.72 64 ND = Not determined MRID: 43424901 Provides information to partially fulfill the data requirement.

Terrestrial Field Dissipation Half-life NC : t 1/2 (in surface soil) = 18.1 days; was only detected in top 6 in soil layer. CA (Fresno) cotton site : t 1/2 reported to be 4.3 days (using 0-7 day data; or 23.8 days if 0-14 day data are used), cyfluthrin was not detected after day 29 post-treatme nt; residues remained in top 6 in soil layer, except for two individual samples. FPB-acid and DCVA were detected in this study. AZ, FL, KS, GA, OR, MS, Canada : DT 50 < 32 days MRID: AN 259211, 44822901, 42794801 Study 42794801 was screened only and a full review will be provided at a later time.36 Table 3.5. Summary of the environmental fate and transport properties of cyfluthrin and beta -cyfluthrin.

PARAMETER VALUE(S) (units) SOURCE COMMENT

Bioaccumulation in Fish (BCF) Maximum BCF=854X for whole fish, with moderate depuration. The only major residue was the parent. The depuration time appears to be ≤ 3 days. MRID: 00143143 –

Cyfluthrin and beta -cyfluthrin are Type II synthetic pyrethroids (they are cyano substituted in the alpha position. Cyfluthrin and beta -cyfluthrin have a 2,2- dichloroethenyl, and they are 2,2-dimethyl substituted in the cyclopropane ring. The database for cyfluthrin has been used as a surrogate fate database for beta -cyfluthrin since they are structurally related. Even though they are Type II pyrethroids that characteristically show more stability to photolysis, submitted laboratory data suggest that the primary routes of dissipation are aqueous and so il photolysis (4.5 and 5.6 days, respectively) and hydrolysis in alkaline media (2.1 days). Cyfluthrin and beta -cyfluthrin are moderately persistent in the environment and immobile (aerobic soil metabolism 73.5-94.8 days, aerobic aquatic metabolism 32.9-42 days). The terrestrial field dissipation data confirm the pattern observed in the laboratory studies with half-lives and DT 50 ’ s in the range of 18-32 days, which would indicate that the chemical follows mix routes of dissipation in the field. The K OC ’s ranged from ~73,000-180,000 mL/g OC , indicating low mobility. Like other pyrethroids, cyfluthrin and beta -cyfluthrin bind strongly to soils suggesting a low potential to leach to subsurfaces and to contaminate groundwater. The moderate pers istence of the chemical, the high soil affinity and very low solubility indicate that the chemicals have a high potential to reach surface waters in runoff events accompanied by erosion occurring during periods of weeks to months after application. Residues could also reach surface waters via spra y drift. Once the chemicals reach surface waters, there is potential impact to water quality, which appears to be mostly due to parent compound. The fate of cyfluthrin in anaerobic environments is uncertain. Cyfluthrin and beta -cyfluthrin are likely to part ition with sediments in bodies of water. Since cyfluthrin may be applie d repeatedly, the material may build up in sediments and affect benthic communities. Cyfluthrin and beta -cyfluthrin are moderately bioaccumulative with moderately rapid rates of depuration (estimated half-depuration time ≤ 3 days). Major metabolites observed in laboratory studies include cis - and trans

DCVA, FPB-acid and FPB-ald ( Table 3.1c ). These compounds result from the hydrolysis of the ester bond of the parent compounds.

Transport The potential impact to water quality from the use of cyfluthrin appears to be mostly due to the parent compound. Laborator y studies show that cyfluthrin is moderately persistent under most environmental conditions maki ng the compound available for runoff. Although the potential for mobility appears low, the likely means of cyfluthrin movement from a crop site to an adjacent body of water would be runoff accompanied by erosion, as well as spray drift. Laboratory studies pr edict that once the chemical reaches surface waters, it may persist for moderate periods of time (relatively stab le at pH 7). Even though cyfluthrin undergoes photolysis in water, its lypophilicity and affinity with particulate should make it unavailable to phot olysis in a short period. In addition,37 photolysis will be limited only to clear shallow waters or the upper layers of the water column. Cyfluthrin does not seem to be a si gnificant threat to gr ound water quality under most conditions. While laboratory conditions show that cyfluthrin is moderately persistent, the very low mobility observed in the laboratory reduces substantially the concern that there would be a potential of the compound to reach ground water. Some supplemental studies indicate th at the potential degradates cis - and trans -DCVA could leach to ground waters. Conclusions with resp ect to the mobility of these degradates are limited by the available data.

Degradation and Metabolism The hydrolysis of cyfluthrin was pH dependent. It was fast in alka line media (stable, essentially stable and 2.1 days at pH’s 5, 7 and 9 respectively). In a supplemental study conducted on filtered Rhine River water (pH 7.7-8.3), in the dark, cyfluthrin hydrolyzed/ degraded with a half-life of 9 days. An impor tant route of dissipation for this chemical may be aqueous photolysis with a non-linear ha lf-life of 0.7 days/ linear 4.5 days in an aqueous solution under natural sunlight. The major degradates were FPB-acid (4-fluoro3-phenoxybenzoic acid) and FPB-ald (4 -fluoro-3-phenoxybenzaldehyde). Soil photodegradation may also be an important route of dissipation for cyfluthrin and beta

cyfluthrin. In soil, photode gradation followed a half-lif e of 5.6 days (dark control corrected). The only phenyl-labeled degradate was FPB-ald (up to 8% of the applied). It is assumed that the degradate DC VA [3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylic acid] is formed in th e hydrolysis and the aqueous photolysis studies. DCVA is stable to hydrolysis at pH’s 4, 7 and 9 (European Commission, Appendix 2).

The aerobic soil metabolism appears to play a less er role in the dissipa tion of cyfluthrin with half-lives in a loam soil and a sandy loam soil, of 73.5 and 94.8 days, respectively. There was some formation of carbon dioxide and the only fluoro-phenyl degradate detected at appreciable amounts was FPB-acid (7 % of the applied). In an anaerobic soil metabolism study, using aged loam, flooded a nd purged with nitrogen and based on two points, a half-life of around 30 days was obtaine d. Two degradates detected at the end of the initial aerobic incubation, FPB-acid and cyfl uthrin-amide (minor degradate), declined during the anaerobic phase. The degradate DCVA was identified in a 100-day aerobic soil metabolism study at >10% of the applie d, as indicated by the European Commission (Appendix 2). In aerobic soil metabolism studies at 25°C at 40% MWHC, the DT50 range for DCVA was 12-62 days (mean 24 days, me dian 16 days, 2 soils, 4 isomers). It is indicated that DT50 FPBacid < DT50 DCVA
. In aerobic aquatic meta bolism studies, conducted on beta -cyfluthrin, based on first order linear regression analysis, the half-lives of cyfluthrin in the total systems were 32.9 and 42.0 days for two German systems, and 20.4 and 22.0 days for two Dutch systems. The quality of the results of the Dutch systems is regarded as low, and those half-lives should not be used for modeling. Three degradates were identified in the aerobic aquatic systems. In the German systems, DCVA was a maximum of 47.63% at 28 days. In the Dutch systems, FPB acid was a maximum of 44.5% at 11 days, and FPB-ald) was a maximum of 15.7% at 1 day. No anaerobic a quatic metabolism studies are available at38 this time.

Sorption and Mobility Cyfluthrin is hydrophobic and was hardly mobile to immobile in four soils (K d range 1116 to 1793 mL/g; K OC range 73,000 to 180,000 mL/g OC ; measurements made at single concentrations, FAO mobility classifi cation, FAO 2000). The chemical will bind strongly to the soil surfaces. There was a linear relationship between the soil organic carbon content and cyfluthrin K d values (r 2 = 0.92). The soils included German loamy sand and silty loam, and US loamy sand and clay loam. At least, some of the degradates formed from the cleavage of th e carboxylate ester are expected to be more mobile than the parent. Supplemental data available to the Agency, indicates that the degradate DCVA is mobile to moderately mob ile in neutral to alkaline soils (K OC range 14 to 356 mL/g OC , FAO mobility classification).

Even though cyfluthrin may be applied aeria lly, by ground or ULV, and drift is possible, the chemical appears to be relativel y non-volatile (vapor pressure 1.5 x 10 -8 mmHg, Henry’s Law Constant 3.7 x 10 -6 atm-m 3 /mol). Furthermore, cyfluthrin readily binds to soils or partitions with suspended matter a nd sediment. Thus, volatilization would be greatly reduced.

Field Dissipation Cyfluthrin, applied on Fairmont, NC sandy soil (sand 90.8%, depth 0-6 inches, 0.33% OM), cropped with cotton, at a rate of 0.55 lb a.i./A, dissipated from the field with a halflife of 18 days (r 2 = 0.94, n = 8), or with a DT 50 of <32 days. Residues were detected only in the top 6” soil layer. No residues were detected below the top 6” of soil depth (sandy loam, 0.33% OM). There were two single detects of Cl 2 CA ( ≤ 0.012 ug/g), and eight, mostly single detects of FPBA ( ≤ 0.016 ug/g). All values were close to the analytical detection limits. Cyfluthrin dissi pated from a cotton site in Fresno, California with a registrant-reported half-life of 4.3 days (using 0-7 day data; or 23.8 days if 0-14 day data are used, but the data point for 14 da ys was higher than for 7 days). Cyfluthrin was not detected after day 29 post-treatment. The DT 50 was ca. 3 days. Residues remained in top 6 in soil layer, except fo r two individual samples. FPBA and DCVA were detected in this study. This study was screened only, but a full review will be conducted at a later time.

In other terrestrial field di ssipation studies, in AZ, FL, KS, GA, OR, MS and Canada different soils, with different organic matter content showed that cyfluthrin (in the form of Baythroid 24% EC), sprayed at 1 kg a.i./ha dissipated with DT 50 ’s of <32 days. In these studies, soil sampling intervals, spaced by 30-32 days were inadequate and prevented accurate half-life calculations. Besides the parent, residues of DCVA and FPB-acid were detected in some studies. Cyfluthrin was detected in the 6-12” cores at levels less than 0.13 mg/Kg in five out of the seven studies.

Bioaccumulation Based on the octanol/ water partition coeffici ent, cyfluthrin show s a high potential to bioaccumulate (K OW = 9.33 x 10 5 ). The bioconcentration fact or in whole rainbow trout39 was moderate (854x, whole fish). Residues were depurated at moderately rapid rates in untreated water (apparent depura tion half-life of approximately ≤ 3 days). Accumulated residues were found mostly in non-edible tissu es, and the only residue detected at high levels was the parent compound.

Transformation Products The fate and transport characterization is also summarized for th e various degradation products formed by each process for the studies reviewed in Table 3.6

.
Table 3.6. Summary of degradate format ion from degradation of cyfluthrin.

DEGRADATE and MAXIMUM CONCENTRATION STUDY TYPE SOURCE F-PB-acid (% app) F-PB-ald (% app) DCVA (% app) Hydrolysis MRID: 00131493, 00137539, 45022101 – 11% at 35 days at pH 7, 89% at 21 days at pH 9 –

Aqueous Photolysis MRID: 00149595, 45022101, 45022102 37% at day 14 18% at day 7 –
Soil Photolysis MRID: 00137543, 00157043 – 18% at days 5-6 –

Aerobic Soil Metabolism MRID: 00131494 10% at 10 days – >10% in 100-day studies Anaerobic Soil Metabolism MRID: 00131494 10% at 30 days of aerobic incubation (time of flooding) – –

Aerobic Aquatic Metabolism MRID: 46824101 44.5% at 11 days 15.7% at 1 day 47.63% at 28 days Terrestrial Field Dissipation MRID: AN 259211, 42794801, 44822901 <0.07 mg/Kg in the 0- 6” cores – 0.16 mg/Kg at 30 days

Major degradates identified in laborator y studies are FPB-aci d, FPB-ald and DCVA result from the rupture of the ester linkage of the synthetic pyrethroid. FPB-acid was identified in the aqueous photolysis, aer obic soil metabolism, and anaerobic soil metabolism studies at 10-37% of the applied at 10-30 days af ter treatment. FPB-ald was observed at significant amounts in photolysis/ photodegrada tion studies at 18% of the applied of the applied (5-7 days posttreatme nt) and in hydrolysis st udies (up to 89% of the applied at pH 9, but only 11% at pH 7). DCVA was identified in supplemental aerobic soil metabolism studies (>10% of the applied). The degradate DCVA was also identified in field stud ies at up to 0.16 mg/Kg.

There is uncertainty with respect to the av ailable data on the cycl opropane side of the ester linkage and cold analyses were not pe rformed on the possible degradates resulting from the rupture of this linkage. There is evidence of the formation of DCVA, but there is no further information on the possible degradation pathways. There are limited data about the mobility and persistence of FPB -ald, FPB-acid and DCVA. While it appears that DCVA is much more mobile than the pa rent compound and has the potential to reach ground waters in vulnerable site s, there are limited data about its mobility. DCVA has been detected in laboratory st udies at >10% of the applied.

Uncertainties The environmental fate database for parent cyfluthrin and beta -cyfluthrin was previously considered adequate to perform a screening level assessment of the chemical. However, the following uncertainties were noted. There is uncertainty related to the anaerobic soil metabolism study. The half-life was very r oughly estimated, based on two data points.40 Also, the fate of cyfluthrin in anaero bic aquatic environm ents is uncertain.

Studies using radiolabeling on the cyclopropa ne side of the ester linkage were not conducted and cold analyses were not perfor med. Consequently, there were no analyses for potential cyclopropane containing degrad ates that may have originated from the cleavage of the carboxylate ester linkage, such as DCVA. At this time, most of the data available are on the fluorophenyl ring only.

EFED has limited data about the environmental fate (mobility and persistence) of degradates of cyfluthrin, FPB-al d, FPB-acid, cyfluthrin amide, and cis /trans -DCVA. The limited data available indicate that DCVA is mobile to moderately mobile and has the potential to reach ground waters in vulnerabl e sites. However, this potential would be limited by the amounts of DCVA produced in the soils because cyfluthrin degrades slowly. It appears that DC VA is not highly toxic to mammals (communication with Carol Christensen, Health Effects Division, 07/0 1/2004). As part of the risk assessment, the EFED will conduct an ECOTOX search for in formation about the possible toxicity of the degradates of cyfluthrin as it will be further indicated below.

The mobility (batch equilibrium) data available for cyfluthrin was obtained at a single concentration. EFED has available K d and K OC values, but no Freundlich K F and K FOC values (no isotherms available).

4. 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 cyfluthrin and beta -cyfluthrin, the types of receptors that may be exposed include both aquatic and terrestrial receptors, such as birds, reptiles, mammals, amphibians, freshwater and estuarine/mari ne fish, non-target te rrestrial & aquatic invertebrates and terrestrial & a quatic plants. This list may not be comprehensive. Spray drift and runoff exposures are expected for both ground and aerial applications of cyfluthrin. Consistent with the process described in th e Overview Document (USEPA, 2004), this risk assessment uses a surrogate species approach in its evaluation of cyfluthrin. Toxicological data generated from surrogate test species, which are intended to be representative of broad taxonomic gr oups, are used to extr apolate to potential effects on a variety of species (receptors) included 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 cyfluthrin and beta -cyfluthrin, by providing the acute toxicity classifications.

Terrestrial Species41 A summary of sensitive terrestrial toxicity data from registrant-submitted studies is provided in Table 4.1 . Based on the available acute data , cyfluthrin is classified as practically nontoxic to birds, moderately toxic to mammals , and highly toxic to terrestrial invertebrates. Avian reproductive studies indi cate reproductive eff ects at 250 mg/kg diet (NOAEC<250 mg/kg diet). A mammalian repr oduction study with cyfluthrin showed adverse effects on pup body weight at 150 ppm (NOAEL=50 ppm). All endpoints are provided in terms of the active ingred ient (ai) unless otherwise specified.

Mammals Mammalian toxicity data s uggest that this compound is moderately toxic to small mammals on an acute basis (rat LD 50 <100 mg/kg bw and mouse LD 50 = 291 mg/kg bw) (Accession #072008 and 004334). Reproductive eff ects were based on decreased pup bodyweight observed at a LOAEC of 150 ppm (NOAEC = 50 ppm) (Accession #072009). For mammalian toxicity in the final risk assessment, EFED will coordinate with HED to determine the most sensitive e ndpoints for acute and chronic studies. In an acute oral study conducted to examine beta -cyfluthrin effects on rats, the LD 50 =960 mg/kg bw (males) and LD 50 =1150 mg/kg bw (females) (MRID 44251101). Based on the submitted data, beta -cyfluthrin appears to have lower toxicity to mammals than cyfluthrin.42 Birds The available toxicity data suggests that cyfl uthrin appears to be practically non-toxic on an acute basis to avian species based on a bobwhite quail ( Colinus virginianus ) single dose LD 50 of >5000 mg/kg bw (00131498, acceptabl e) and an 8-day dietary LC 50 of >5000 mg/kg diet for the bobwhite quail and mallard duck ( Anas platyrynchos ) (00131500 and 0013501, both acceptable).

Reproductive tests with mallard ducks indica ted effects at 250 mg/kg diet (NOAEC <250 mg/kg diet). In one test conducted with mallard s, a high percentage of eggs cracked were observed at 250 mg/kg diet, the lowest level tested (MRID 00145331, supplemental). This effect was not seen at the higher trea tment levels, however. Other adverse effects shown at the 1000 and 4000 mg/kg diet levels in clude a reduction in the number of eggs laid, eggs set, fertilized e ggs, 3-week viable embryos, hatc hlings and 14-day survivors. Due to low control reproductive performance, including low embryo viability, hatchling number and 14-day survivorship, the results of this study are classified as supplemental. In another one-generation reproductive st udy conducted on mallard ducks, cyfluthrin statistically showed no adverse effects to repr oduction at the highest concentration tested when compared to control bird s (NOAEC = 250 mg/kg diet) (MRID 00158782, supplemental). In this study, no statistical differences in reproductive parameters between the controls and treatments were de termined at any concentration tested (10, 50 and 250 mg/kg diet). Response variables examin ed include eggs lai d, eggs cracked, eggs set, viable embryos, 3-week embryos, ha tchlings and 14-day survivors per hen. Pathological results showed an increase in egg yolk peritonitis and regressing ovary at levels as low as 10 mg/kg diet (lowest le vel tested). In this study, control bird reproduction appeared to be impaired, as indi cated by a low number of eggs laid, embryo viability and hatching rate compared to guideline criteria.

Two studies were submitted for bobwhite quail, yielding less sensitive reproductive endpoints than the mallard studies. Th e NOAEC = 900 and 1000 mg/kg diet, for MRIDs 00152829 (acceptable) and 00145330 (supplemental) , respectively. Effects observed include low body weight gain in males and lo w 14-day survivorship at 4000 mg/kg diet level.

Terrestrial Invertebrates

Cyfluthrin is highly toxic to nontarget terres trial invertebrates. A 48-hour acute contact study on honeybees ( Apis mellifera ) with cyfluthrin technical produced an LD 50 = 0.037 μg/bee (MRID 00153638, acceptable). A 10-day honey bee residual toxicity study with cyfluthrin 2 EC (Baythroid) indicated that th e formulated product is also highly toxic to nontarget terrestrial inve rtebrates, with and EC 50 of 0.045 μg/bee (MRID 00162586).

Terrestrial Plants No terrestrial plant data have been submitted to the Agency for cyfluthrin.43 Table 4.1. Summary of most sensitiv e endpoints from submitted terrestria l toxicity studies for cyfluthrin and beta -cyfluthrin.

Species

(common

name) Taxa Represented Endpoint Concentration Test Substance

(% a.i.) MRID and classification Acute Toxicity Classification

Rattus norvegicus
(Laboratory Rat) LD 50 Cyfluthrin: <100 mg/kg bw

Beta -cyfluthrin : 960

mg/kg bw (male)

1150 mg/kg bw (female) tech Accession #072008 Acceptable

44251101 Acceptable

Mus musculus

(Laboratory

mouse) LD 50 291 mg/kg bw (male) 609 mg/kg bw (female) tech Accession #004334
Acceptable Moderately toxic

NOAEL 50 ppm Rattus norvegicus
(Laboratory Rat) Mammals

LOAEL 150 ppm tech Accession #072009
Acceptable NA

Colinus virginianus (Bobwhite

quail) LD 50 >5000 mg/kg bw 87 00131498 1 Practically non-toxic

Anas platyrynchos (Mallard duck)

and

Colinus virginianus (Bobwhite

quail) LC 50 >5000 mg/kg diet 87 00131500 2

00131501 2 Practically non-toxic

NOAEC <250 mg/kg diet Anas platyrynchos (Mallard duck) Birds, terrestrialphase amphibians, and reptiles

LOAEC 250 mg/kg diet 94% 00145331 3

Supplemental NA

Apis mellifera

(Honey bee) Terrestrial invertebrates LD 50 0.037 μg/bee 93% 00153638
Acceptable Highly toxic

1 Original review classified the study as acceptable, completed in 1983 by W. Faatz. Study not required at this time because a cursory review indicates that the study is acceptable, but may be required pending additional data evaluation.
2 Data need additional review. Origin al reviews classified the study as acceptable, completed in 1984 by W.44 Faatz. Study not required at this time because a cursory review indicates that the study is acceptable, but may be required pending additional data evaluation.
3 This endpoint is based on the most sensitive registrant-submitted study available. However, in this study, the endpoint is non-definitive. Another study co nducted on mallard ducks with lower treatment concentrations (10-250 mg/kg diet) showed no re productive effects at any treatment levels. NA=not applicable

Aquatic Species A summary of sensitive aquatic toxicity da ta from registrant-submitted studies is provided in Table 4.2 . Numerous aquatic studies have been submitted to the Agency, some of which were conducted with beta -cyfluthrin. Appendix B includes a table detailing all aquatic toxicity data submitted to the Agency. Cyfluthrin and beta

cyfluthrin are classified as very highly toxic to aquatic organisms based on data for aquatic vertebrates and invertebrates. Chronic e ffects were also seen in all aquatic taxa at levels ranging from 0.00040 – 0.63 μg a.i./L.

Freshwater Cyfluthrin technical is highly toxic to freshwater fish, with a 96-hour LC 50 = 0.68 μg a.i./L (MRID 00131502). Beta -cyfluthrin technical is also hi ghly toxic to freshwater fish, with a 96-hour LC 50 = 0.068 μg a.i./L in the most sensitive acute test conducted on rainbow trout ( Oncorhynchus mykiss) (MRID 45375002). In an acute test with cyfluthrin EC (2%), the 96-hour LC 50 = 0.295 μg a.i./L for rainbow trout (MRID 41558002, supplemental)

. A freshwater fish early-life stage study for cyfluthrin technical resulted in an NOAEC of 0.010 μg a.i./L and LOAEC of 0. 018 μg a.i./L for rainbow trout based on reduced growth and behavioral effects (MRID 00155898, supplemental). In a fish full life cycle test with cyfluthrin, fathead minnow ( Pimephales promelas ) showed reduced survival and hatching success at 0.25 μg a. i./L, with a NOAEL = 0.14 μg a.i./L (MRID 41450401, acceptable).

Daphnia magna is used as the test species for fres hwater invertebrates for both acute and chronic effects. Acute toxicity values for daphnids suggest th at cyfluthrin technical is very highly toxic to freshwater invertebrates, with a 48-hour EC 50 of 0.141 μg a.i./L (MRID 00131504). An acute 48-hour study examining beta -cyfluthrin technical effects to daphnids produced an EC 50 = 0.29 μg a.i./L (MRID 45426701). A 48-hour study conducted with the formulated product (Tem po, 25% a.i.) showed higher toxicity to daphnids, with an EC 50 of 0.025 (MRID 41558003). Chronic toxi city to invertebrates is represented through Daphnia magna life cycle studies. In a daphnid chronic life-cycle test with cyfluthrin, the NOAEC = 0.00174 μg/L and the LOAEC = 0.0157 μg/L based on adverse effects to growth, survival and # of young (MRID 00151442, acceptable). In this study, cyfluthrin showed significant degrad ation, due to hydrolysis at the high pH (8 to 8.5). Based on results from thin layer ch romatography analysis, it was determined that approximately 37% of the total carbon-l abelled residues were the parent compound. Therefore, the mean-measured concentrations we re adjusted to reflect the percentage of cyfluthrin in the final endpoint calcul ations (endpoints based on mean-measured 14 C concentrations alone were NOAEC=0.020 μg/L and LOAEC=0.041 μg/L).

For freshwater benthic organisms, a 10-day toxicity study with midges ( Chironomus45 tentans ) has been submitted (MRID 46591507, in revi ew). Based on preliminary results from this study, cyfluthrin is very highly toxic to freshwater be nthic organisms and the LC 50 =0.44 μg a.i./L based on mean-measured pore water concentrations and LC 50 =290 μg a.i./kg sediment based on bulk sediment concentrations.

Estuarine/Marine Estuarine/marine fish are repres ented by the sheepshead minnow ( Cyprinodon variegatus ). Acute toxicity studies indicates that cyfluthrin is very highly toxic to estuarine/marine fish, with an LC 50 = 4.05 μg a.i./L for the technical material (MRID 00146485, acceptable). The most sensitive sheepshead minnow early life stage study submitted by the registrant resulted in a 39-day NOAEC = 0.025 μg a.i./L and a LOAEC = 0.084 μg a.i./L, based on reduced juvenile su rvival. Another early life stage study has been submitted, yielding less sensitive endpoi nts based on treatment-related mortality (NOAEC=0.27 μg a.i./L and LOAEC = 0.63 μg a.i./L) (MRID 00158784, this study is currently unreviewed).

Estuarine/marine aquatic invertebrates are represented by the mysid shrimp ( Mysidopsis bahia ) and eastern oyster ( Crassostrea virginica ) with toxicity studies indicating cyfluthrin is very highly toxic to both. Cyfluthrin technical produced an LC50= 0.0024 μg a.i./L in an acute toxicity study w ith mysid shrimp (MRID 40069501). In an acute study with mysid shrimp, the 96-hour LC 50 = 0.0022 μg a.i./L for beta -cyfluthrin technical (MRID 45426709, acceptable). In a stu dy with the eastern oyster, the 96-hour EC 50 was 2.69 μg a.i./L for cyfluthrin technical (MRID 00158783, acceptable). A chronic study with estuarine/marine invertebrates has also been submitted for cyfluthrin technical. In a 28-day life cycle stud y with mysid shrimp, the NOAEC = 0.00017 μg a.i./L and LOAEC = 0.00040 μg a.i./L based on adverse effects to growth and survival (MRID 00158785, supplemental). This study was deemed supplemental due to fluctuations in the test co ncentrations throughout the study.

Aquatic Plants A 96-hour toxicity test with the green algal species Scenedesmus subspicatus was submitted for cyfluthrin, but the test was de termined to be invalid due to low test substance solubility and absence of anal ytically-determined concentrations (MRID 41450402). Another study with green algae ( Pseudokirchneriella subcapitata , formerly known as Selenastrum capricornutum ) has been submitted for cyfluthrin (MRID 43984901). The reported EC 50 > 181 μg a.i./L and NOAEC = 181 μg a.i./L in this study, based on Day 0 soluble measured concentrations. No studies have been submitted for aquatic vascular plants.

Toxicity of Degradates Four aquatic toxicity studies have been submitted for degradates of cyfluthrin, FPB ALD and DCVA. Both degradates appear to be le ss toxic than the pare nt compound based on acute toxicity studies with fr eshwater fish and invertebrate s. Studies with rainbow trout resulted in a 96-hour LC 50 = 792 μg a.i./L for FPB ALD and LC 50 >14.7 mg a.i./L for DCVA (MRIDs 00158554 and 00158557). Acute 48-hour studies with Daphnia magna resulted in an EC 50 =1.3 mg a.i./L for FPB ALD and EC 50 =25 mg a.i./L for DCVA46 (MRIDs 00158555 and 00158556). Therefore, the pare nt compound is expected to be the primary stressor of concern.

Table 4.2. Summary of most sensitive endpoin ts from submitted aquatic toxicity studies for cyfluthrin and beta -cyfluthrin

Species

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

(μg a.i./L) MRID
Study Classification Acute Toxicity Classification

LC 50 96 Cyfluthrin: 0.68

Beta

cyfluthrin:

0.068 00131502 Acceptable

45375002 Supplemental Very highly toxic

NOAEC 0.010 Oncorhynchus mykiss (Rainbow trout) Freshwater fish and aquatic-phase

amphibians

LOAEC 58 (days) 0.018 00155898 Supplemental NA

Crassostrea

virginica (Eastern oyster) EC 50 96 2.69 00158783
Acceptable

EC 50 48 Cyfluthrin: 0.025

Beta

cyfluthrin: 0.29 41558003
Acceptable

45426701
Supplemental Very highly toxic

NOAEC 0.0074 Daphnia magna

(Water Flea) Freshwater Invertebrates

LOAEC 21 (days) 0.0157 00151442
Acceptable NA

Chironomus tentans (Midge) Freshwater Benthic Invertebrates LC 50 10 (days) 0.44 (pore water) 290 μg a.i./kg sediment

(bulk sediment) 46591507

In review Very highly toxic

LC 50 96 4.05 00146485
Acceptable Very highly toxic

NOAEC 0.025 Cyprinodon variegatus (Sheepshead

minnow) Estuarine/ Marine Fish

LOAEC 39 (days) 0.084 00158781 Supplemental NA47 Table 4.2. Summary of most sensitive endpoin ts from submitted aquatic toxicity studies for cyfluthrin and beta -cyfluthrin

Species

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

(μg a.i./L) MRID
Study Classification Acute Toxicity Classification

LC 50 96 Cyfluthrin:
0.0024

Beta

cyfluthrin:

0.0022 40069501

Acceptable

45426709
Acceptable Very highly toxic

NOAEC 0.00017 Mysidopsis bahia

(Mysid shrimp) Estuarine/ Marine Invertebrates

LOAEC 28 (days) 0.00040 00158785
Supplemental NA

Leptocheirus plumulosus
(Amphipod) Estuarine/ Marine Benthic Invertebrates LC 50 (survival)

EC 50 (growth) 28 (days) 35

36 46591506

In review Very highly toxic

Green algae
( Pseudokirchneriella subcapita ) Aquatic Plants EC 50 96 >181 43984901
Acceptable Practically nontoxic

ECOTOX Available open literature will be used to evaluate the potential direct effects of cyfluthrin and beta -cyfluthrin to the terrestrial receptors identified in this section. This includes toxicity data on the technical grade active i ngredient, and when av ailable, formulated products.

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 cyfluthrin and beta -cyfluthrin on biotic communities from loss of species that are sens itive to the chemical and from changes in structure and functional characteristics of the affected communities.

Open literature toxicity data for other ‘target’ insect species (not including bees, butterflies, beetles, and non- insect invertebrates including soil arthropods and worms), which include efficacy studies, are not currentl y considered in deriving the most sensitive48 endpoint for terrestrial insects. Efficacy studies do not typically provide endpoint values that are useful for risk assessment ( e.g. , NOAEC, EC 50 , etc.), but rather are intended to identify a dose that maximizes a particular effect ( e.g. , EC 100 ). Therefore, efficacy data 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 May 20, 2010 of the Ecological Incident Information System (EIIS, version 2.1), which is maintained by th e Agency’s Office of Pesticide Programs indicates reported ecological incidents associated with the use of cyfluthrin and beta

cyfluthrin. A search for inci dents involving cyfluthrin and beta -cyfluthrin was also conducted in the American Bird Conserva ncy’s Avian Incident Monitoring System (AIMS). These incidents are summarized in Table 4.3 . This total excludes incidents classified as ‘unlikely’ a nd only includes those incidents with certainty categories of ‘highly probable’, and ‘probable’ and ‘possible’ (for EIIS) an d ‘certain’, ‘highly likely’, ‘likely’, ‘probable’, and ‘possi ble’ (for AIMS). In the E IIS and AIMS databases, the “unlikely” category is used when a chemical is not likely to be responsible for the incident. For example, an ‘unlikely’ classifi cation 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 in cident. Incidents classified as ‘unlikely’ for cyfluthrin and beta -cyfluthrin will not be included in this Problem Formulation or the ecologi cal risk assessment conducted for Registration Review.

A total of eight reported ecologi cal incidents associated with the use of cyfluthrin have been reported to the Agency. No incidents associated with beta -cyfluthrin were found in the EIIS database. This is likely due to the f act that enantio selective methods are required for differentiating cyfluthrin and beta -cyfluthrin. Therefore, cy fluthrin incidents cannot be ruled out as possible beta -cyfluthrin incidents.

Five incidents were reported for aquatic an imals and three are reported for terrestrial plants. All incidents were reported between 1993 and 2005. Four of the incidents were associated with registered uses of cyfluthri n, two were associated with uses where it was undetermined if the use was a registered use, and two incidents we re associated with misuse. The certainty that the incidents were associated with cyfluthrin exposure was considered highly probable for two incidents, probable for f our incidents and possible for two incidents. See Table 4.3 for summary of the incidents.

The AIMS database contains no in cidents involving cyfluthrin and beta -cyfluthrin.

Table 4.3. Wildlife Incidents Associated with Cyfluthrin

Incident Number Taxa Involved Magnitude Year Location (County,

State) Use Legality of Use Certainty Category 1 Residue49 Table 4.3. Wildlife Incidents Associated with Cyfluthrin

Incident Number Taxa Involved Magnitude Year Location (County,

State) Use Legality of Use Certainty Category 1 Residue

I004564-

0011 Koi fish ( Cyprinus

carpio ) 5 1996 CA Building Spray RU Highly Probable No

I003621- 001 Bluegill ( Lepomis macrochirus ) unknown 1996 Not reported Not reported M Probable No

I003351- 021 Crayfish (Decapoda)

and snail (Gastropoda) hundreds 1994 Placer, CA Not reported UN Probable No

I013927- 001 Flathead catfish ( Pylodictis oilvaris ),
grass carp ( Ctenopharyn godon idella ) and largemouth bass ( Micropterus salmoides ) 400 2003 Imperial, CA Agricultural UN Probable 220-390 ppb in

gill tissue,

0.33 ppb in
water

I009427- 006 Crayfish (Decapoda) Unknown 1999 Madison, LA Aerial to
cotton RU Possible No

I016940- 010 Corn ( Zea
mays ) 30 acres 2005 Imperial, CA Aerial M Highly probable 0.15-7.2 ppm in

plant tissue

I001728- 001 Unknown ornamentals Unknown 1993 WA Commercial lawn RU Probable Yes, levels

not reported

I013550- 002 Potatoes 65 acres 2001 Kent , DE Aerial RU Possible No

1 Incidents classified as ‘unlikel y’ are excluded; RU = Registered Use; M = Misuse; UN = Unknown50 Aquatic Incidents In volving Cyfluthrin

 Incident # I004564-001 – A fishkill in two ornamental ponds occurred due to cyfluthrin

use in California in 1996. Cyfluthrin ( TEMPO) dust was sprayed on the side of a building to control wasps. Around five days after application, approximately five koi fish ( Cyprinus carpio ) began to die in ponds 20-30 feet away. Water samples taken 20 days after application contai ned 2 ppb cyfluthrin. No analyses were conducted on the fish tissues. This incident is listed as “highly probable” for a registered use of cyfluthrin.

 Incident # I003621 -001 – After a heavy rainfall, cyfl uthrin (Aztac 2.1%) washed into a

stream where hundreds of bluegill ( Lepomis macrochirus ) were subsequently killed. The incident occurred in 1996. No water or ti ssue samples were taken. This incident is listed as “probable” for an inte ntional misuse of cyfluthrin.

 Incident # I003351-021 – Cyfluthrin was the probable cause of the death of hundreds

of crayfish (Decapoda) and snails (Gastr opoda) in California in 1994. No other data were reported. This incident is listed as “pr obable” for cyfluthrin. It is unknown if the incident was due to a registered use or misuse.

 Incident # I013927-001 – Cyfluthrin was the probable cause of a fish kill in California

in 2003, reported the California Departme nt of Fish & Game. Cyfluthrin and chlorpyrifos were aerially applie d to an agricultural field adja cent to the site of the kill. Approximately 400 fish died, in cluding 320 flathead catfish ( Pylodictis oilvaris ), 60 grass carp ( Ctenopharyngodon idella ) and 20 largemouth bass ( Micropterus salmoides ). Two water samples were analyzed, and chlorpyrifos was found in both water samples (0.08 and 11.7 ppb) and cyflut hrin was found in one sample (0.33 ppb). Analyses of fish gills ranged fr om 220-390 ppb cyfluthrin and 660-2100 ppb chlorpyrifos. The report states that “there was probably some dilution of the water between the time of application of the pest icides and the time of sampling”. This incident is listed as “proba ble” for cyfluthrin. It is unknown if the incident was due to a registered use or misuse.

 Incident # I003351-021 – Cyfluthrin (Baythroid) was th e possible cause of death to an

unknown number of crayfish (Decapoda) in L ousiana in 1999. Both cyfluthrin and profenofos were aerially applied to co tton fields 100 yards from 200 acres of ponds. The Lousiana Department of Agriculture took water samples 8 hours after the application and found neither chemical (LOD= 1.4 ppb for cyfluthrin and LOD=1.48 ppb for profenofos). Bayer Cropscience, the regi strant, said the incident may be due to low dissolved oxygen levels. This incident is listed as “possi ble” for a registered use of cyfluthrin.

Terrestrial Plant Incide nts Involving Cyfluthrin51  Incident # I016940-010 – A crop duster experienced mechanical problems and

discharged cyfluthrin (Bay throid) and dimethoate (Pr okil) onto a corn field ( Zea mays ). A few days later the corn field showed burn symptoms in 30 acres of the crop. Around 7,500 pounds of the crop were sampled for re sidues, and the two chemicals were found in 2,500 pounds (the grower voluntarily disposed of this portion). The analysis showed 0.15 to 7.2 ppm of cyfluthrin and 0.96 to 119.2 ppm of dimethoate. This incident is listed as “highly probable” for a misuse of cyfluthrin.

 Incident # I001728-001 – In Washington state, a co mmercial applicator sprayed

cyfluthrin in a yard, which re sulted in drift to a neighbor’s garden. Damage to unknown species of ornamentals ensued. The type and magnitude of the damage was not reported. Soil samples from the neighbor’s gard en tested positive for cyfluthrin (levels not reported). This incident is listed as “probable” for a re gistered use of cyfluthrin.

 Incident # I013550-002 – A Delaware potato grower aerially applied cyfluthrin

(Baythroid), chlorothalonil (Bravo Ultrex) a nd spinosad (Spin Tor 2SC) to 65 acres of his crop, and damage to the plants occurred within 2 days. The Department of Agriculture investigated and determined there was glyphosate contamination in the containers. This incident is listed as “possible” for a registered use of cyfluthrin.

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, sublethal 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 reductions in state monitoring effort s due to lack of resources.

In the risk assessment, these incidents will be further evaluated to determine if they represent current patterns of use for cyfluthrin and/ or beta -cyfluthrin. Examples of additional considerations are mitigation ( e.g ., reduced application rates), product cancellations, and changes in use patterns th at have occurred since the date of the reported incidents.

As it has been indicated earli er, cyfluthrin is among the constituents monitored by the National Water Quality Assessment Data Wa rehouse, (NAWQA) maintained by the U.S. Geological Survey; furthermore, multiple articles from the literature document the presence of synthetic pyrethro ids like cyfluthrin and/ or beta -cyfluthrin in both urban and agricultural water and sediments (refer to Section 3.4 ).

4.3. Ecosystems Potentially at Risk

Cyfluthrin and beta -cyfluthrin may be applied on a va riety of food crops, including (but not limited to) alfalfa, tree nuts, pome fruits, brassica (head and stem ) vegetables, fruiting52 vegetables, leafy vegetables, legume vegetables and root and tuber vegetables. In addition, they may be used in numerous non-food sites ( e.g. ornamental and/ or shade trees and ornamental lawns). Thus, the ecosyst ems at risk may be extensive in scope, and as a result it may not be possi ble to identify specific ecosystems during the development of a baseline risk assessment. In general term s, terrestrial ecosystems potentially at risk due to the use of cyfluthrin and beta -cyfluthrin, could include th e treated field and areas immediately adjacent to the treated field that may receive drift or runoff. Areas adjacent to the treated field could in clude cultivated fields, fen cerows and hedgerows, meadows, fallow fields or grasslands, woodlands, riparian habitats and other uncultivated areas. Due to the potential persistence of cyfluthrin and beta -cyfluthrin, they are expected to drift and/or runoff due to application to food crops, resulting in possible exposure to aquatic ecosystems. Aquatic ecosystems potentiall y at risk due to th e use of cyfluthrin and beta -cyfluthrin include water bodies adjacent to, or down stream from, the treated field and might include impounded bodies such as ponds, lakes and reservoirs, or flowing waterways such as streams or rivers. For us es in coastal areas, aquatic habitat also includes marine ecosystems, such as 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) identifying 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 cyfluthrin and beta -cyfluthrin.

To estimate exposure concentrations, th e ecological risk assessment considers applications at the maximum application rate to fields that have vulnerable 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.53 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 cyfluthrin and/ or beta -cyfluthrin. More sensitive endpoints from acceptable open literature studies will be in cluded 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 cyfluthrin or beta -cyfluthrin, 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 (USEPA, 1998).

6.1. 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 (U SEPA 1998). For this assessment, the risk is stressor-initiated, where the stresso r is the release of cyfluthrin and beta -cyfluthrin into the environment. The following risk hypothese s are presumed for this screening-level
assessment:

Cyfluthrin and beta-cyfluthrin, 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 cyfluthrin and beta-cyfluthrin have the potential to cause reduc ed survival, growth, and reproduction to non-target terrestrial and/ or aquatic animals and plants.

Cyfluthrin and beta-cyfluthrin, when used indoors, in accordance with current labels, may result in off-site movement of the compound via wash-off into surface waters via drains and treatment plants, leading to exposure of nontarget aquatic animals and plants. This potential exposure pathway may result in adverse effects upon the survival, growth, and/ or reproduction of non-target aquatic animals and plants.

The conceptual model is a generic graphic de piction of the risk hypothesis. It includes54 the potential pesticide or stressor (cyfluthrin, beta -cyfluthrin and possible metabolites), the source of the pesticide and/or trans port pathways, exposure 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 insecticides cyfluthrin and beta -cyfluthrin, which are Type II synthetic pyrethroids, having multiple outdoor agricultu ral and non-agricultural uses, are capable of affecting aquatic and terrestrial animals provided that environmental concentrations are sufficiently elevated as a result of propos ed label uses. Based on an examination of the physicochemical properties of cyfluthrin and beta -cyfluthrin, the fate and disposition in the environment, and mode of applica tion, a conceptual mode l was developed that represents the possible relati onships between the stressors, ecological recept ors, and the assessment endpoints. Through a preliminary iterative process of examining available data, the conceptual model ( i.e ., the representation of the ri sk hypothesis) may be refined to reflect the likely exposure pathways and the organisms that are most relevant and applicable to this assessment (see Figures 6.1a and 6.1b , below). They include the potential pesticide or stre ssor (cyfluthrin and/ or beta -cyfluthrin, but the presence of toxicologically important metabolites cannot be ruled out), the sources and/ or transport pathways, exposure media and exposure point s, 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 feasible 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. 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 cyfluthrin and beta -cyfluthrin, the sources and mechanisms of release of the compound are from ground or aeria l spray or ULV applications. Note that this conceptual model also considers agri cultural applications as well as certain nonagricultural applications. Surface runoff from the areas of application is assumed to depend on factors such as topogr aphy, irrigation, and rainfall events. Direct deposition may result in contamination of food items that may be consumed by terrestrial organisms. Spray drift results in contaminated adjacent ar eas, including bodies of water. Notice that leaching to groundwater is not considered an important source because cyfluthrin and beta -cyfluthrin are relativ ely imm obile. Due to cyfluthrin and beta -cyfluthrin’s potential for volatilization, atmospheric transport cannot be ruled out. Despite the fact that55 cyfluthrin and beta -cyfluthrin show a moderate He nry’s Law Constant, that would suggest some potential for volatilization, and it is moderately persistent in various environmental media, the hydroxyl radical reac tion half-life for the chemical is 0.86 days (EPI Suite v.4.0 estimate). The short (atmos pheric) half-life sugge sts that the potential for atmospheric transport for cyfluthrin and beta -cyfluthrin is relatively low and that this source of the chemical is of low importance, co mpared to spray drift, runoff and/ or direct contact after application.

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 (fish, amphibians and aquatic invertebrates) can also occur through impact to various food chains. It was estab lished earlier in this docu ment that cyfluthrin and beta

cyfluthrin have the potential to bioaccumu late/ bioconcentrate. The representative aquatic receptors are certain fr eshwater and estuarine/ marine fish, invertebrates, and, in certain cases, aquatic plants. The major poi nt of exposure for terrestrial animals is consumption of food contaminated with residues such as grass, foliage, and small insects. For plants, the point of exposure is direct contact or root uptake . The representative terrestrial receptors are mammals, birds and terre strial plants. The attribute changes used to assess risk to terrestrial recep tors depend on the type of test ( e.g. , reduced survival, growth, or reproduction for animals and seed ling emergence and vegetative vigor 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 c onsidered as surrogates for other taxa. For example, fish are considered surrogates for aquatic phase amphibians. Other attribute changes are related to the food chain and ha bitat integrity. Changes in the food chain include, for example, reduction in prey and m odifications in primary constituent elements (PCEs). PCEs are physical and biological feat ures essential to the conservation of the listed species. Changes in habitat integrity include, for example, reduction in primary productivity.

This conceptual model also shows some de tails about biomagnification for a chemical (see piscivorous birds and mammals in Fig. 6.1a ). Cyfluthrin and beta -cyfluthrin have a very high K OW and according to its physicochemical a nd fate properties, there would be a potential for bioaccumulation/bioconcentra tion in aquatic organisms; however, the potential for biomagnification in terrestrial organisms, though at the screen level appears low, is uncertain and has not been quantified.

Cyfluthrin and beta -cyfluthrin show a very low solubility, a very high K OW and also high K OC s. These properties suggest that the chemi cal partitions with the sediments, and with organic matter, suspended in the water bodies. Cyfluthrin and beta -cyfluthrin are likely to concentrate and persist in the sediments, especially after repeated exposures (applications). Such sediments could serve as repositories of the chemical for extended periods of time and could potentially be toxi c to sediment dwelling organisms, affecting the food chain. These issues will also be asse ssed in the risk assessment for cyfluthrin and beta -cyfluthrin.56 Figure 6.1a. Conceptual model depicting stressors, exposure pathways, and potential effects to aquatic organisms from the use of cyfluthrin or beta -cyfluthrin on agricultural and certain non-agricultural sites Dotted lines indicate exposure pathways that have a low likelihood of contributing to ecological risk. PCE=primary constituent element **Route of exposure includes only ingestion of fish and aquatic inverts. 

### Stressor

Source

Receptors

Attribute Change Cyfluthrin or beta -cyfluthrin applied to agricultural or non-agricultural use site

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 

### Exposure Media

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 6.1b57 Figure 6.1b. Conceptual model depicting stressors, exposure pathways, and potential effects to terrestrial organi sms from the use of cyfluthrin or beta

cyfluthrin on agricultural and certain non-agricultural sites Dotted lines indicate exposure pathways that have a low likelihood of contributing to ecological risk. PCE=primary constituent element

Indoor uses can result in discha rges of cyfluthrin and beta-cyfluthrin into sewer systems and subsequently into publicly owned tr eatment works (POTWs), and to aquatic ecosystems. These discharges of cyfluthrin and beta-cyfluthrin will be included in the assessment as a possible route of exposure to the environment. Exposure estimates could be used to evaluate potential effects to eco logical entities. The conceptual model for potential risks of cyfluthrin or beta -cyfluthrin to aquatic organi sms due to various indoor uses of the chemical that could potentially end up in a “drain” is depicted in Fig. 6.2

. The stressor is the chemical of concern, cyfluthrin and beta -cyfluthrin. It is noted that the transport pathway is wastewater flow, the expos ure media is the treatment facility, but the exposure point or route, receptor and attribut e changes for aquatic organisms are similar to the conceptual model for agricultural and urban applications (as depicted in Fig. 6.1a ).

Stressor

Source

Attribute Change Cyfluthrin or beta -cyfluthrin applied to agricultural

or non-a g ricultural use site

Direct application Spray drift

Terrestrial vertebrates Terrestrial invertebrates

Individual organisms 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 Exposure Media & Receptors Soil

Ingestion Ingestion Ingestion Dermal uptake/Ingestion Atmospheric transport

Root uptake/contact Wet/dry deposition

Ingestion Leaching to Groundwater Irrigation

water58 Figure 6.2. Conceptual model for po tential risks of cyfluthrin and beta -cyfluthrin to aquatic organisms for various indoor uses of the chemical that could potentially end up in the “drain.”

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 cyfluthrin and beta -cyfluthrin are characterized and integrated to assess the risks. This is accomplished using a risk quotient (ratio of exposure concentration to effects concentration) approach. Although ri sk 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 Docu ment (USEPA 2004), the likelihood of effects to individual organisms from particular uses of a chemical is estimated using the probit dose-response slope and either the level of concern (discussed below) or the actual calculated risk quotient value.

This analysis plan will be revisited and may be revised de pending on the data available in

Stressor Cyfluthrin and Beta -cyfluthrin Applications that Could Potentiall y End U p “Down-the-drain”

Source/ Transport Pathways Wastewater flow

Source/ Exposure Media Treatment Facility Discharges into Surface Waters

Exposure Route Gill/ Integument

Uptake

Receptors

Attribute Changes Aquatic Invertebrates, Vertebrates

Individual Vertebrates and Invertebrates Reduced survival or reproduction Plant Population Reduced population growth Aquatic Plants Uptake/ Adsorption59 the open literature and the information s ubmitted by the public or the registrant in response to the opening of the Registration Review docket.

7.1. Stressors of Concern

The focus of this assessm ent is on th e parent materials, cyfluthrin and beta -cyfluthrin. However, the Agency will review available studies to identify degradate(s) of potential toxicological concern ( e.g. , DCVA, FPB-acid and FPB-ald).

Toxicity data for environmental mixtures of cyfluthrin and beta -cyfluthrin with other pesticides (those mixtures occurring in the environment following application), if available, may be presented as part of the ecological risk assessment. Cyfluthrin and beta -cyfluthrin may be applied in tank mixtures with other products approved for use on registered crops. It is expected that the toxic effect of cyfluthrin and beta -cyfluthrin, in combination with other pesticides used in the environment, is likely to be a function of many factors including, but not ne cessarily limited to (1) the exposed species, (2) the cocontaminants in the mixture, (3) the ratio of cyfluthrin and/ or beta -cyfluthrin and cocontaminant concentrations, (4) differences in the pattern and duration of exposure among contaminants, and (5) the differentia l effects of other physical/ chemical characteristics of the receiving waters ( e.g. organic matter present in sediment and suspended water). Quantitatively predicting th e combined effects of all these variables on mixture toxicity to any gi ven taxa with confidence is beyond the capabilities of the available data and methodologies. However, a qualitative discussion of implications of the available pesticide mixture effects da ta 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 cyfluthrin and beta -cyfluthrin exposures in aquatic and terrestrial environments, all exposure mode ling and resulting risk conclusions will be made based on maximum application rates for the current use patterns. Measures of exposure are based on aquatic a nd terrestrial models that pr edict estimated environmental concentrations of cyfluthrin and beta -cyfluthrin using maximum labeled application rates and methods, as well as any mitigation measures specifically indicated on the label. The models used to predict aquatic EECs are the Pesticide Root Zone Model coupled with the Exposure Analysis Model System (PRZM/EXAM S). Also, to estimate exposure related to releases of cyfluthrin and beta -cyfluthrin from domestic wa stewater treatment plants, the Exposure and Fate Assessment Screening Tool’s (EFAST2) down-the-drain modulewill be used. The model used to predict terrestrial exposure to birds and mammals is TREX. The model used to derive EECs rele vant to terrestrial and wetland plants is TerrPlant. The potential for bioaccumulati on for the chemical is assessed using the KABAM model, as well the results from bioconcentration in fish studies ( e.g. the bioconcentration factors). 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. All of these models are parameterized using relevant reviewed registrant-submitted60 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 exposures and 1-in-10 year EECs of cyfluthrin and beta -cyfluthrin, that may occur from spray drift and runoff to surface water bodies adjacent to application sites. PRZM simulates pesticide application, movement a nd transformation on an agricultural field 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 resu lting concentrations in the water body. The standard scenario used for ecological pesticide assessments assumes application to a 10-hectare agricultu ral field that drains into an adjacent 1- hectare water body that is 2 meters deep ( 20,000 cubic meters volume) with no outlet. PRZM/ EXAMS is used to estimate screeni ng-level exposure of aquatic organisms to cyfluthrin and/ or beta -cyfluthrin and/ or th eir transformation products, should they be of concern. The measure of exposure for aquatic sp ecies is the 1-in-10 year return peak or rolling mean concentration. 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 assessing chronic exposure to fish and aquatic-phase amphibians. The 1-in-10-year 21-day mean is used for assessing aquatic invertebrate chronic exposure.

Given the aquatic toxici ty of cyfluthrin and beta -cyfluthrin and thei r likelihood to occur in sediment, the Agency will also consider th e potential exposures resulting from benthic/ sediment concentrations (EECs). Pore wa ter concentrations are commonly used to predict toxicity of non-ionic substances in sediments and characterize 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.

To estimate exposure related to releases of cyfluthrin and beta -cyfluthrin from domestic wastewater treatment plants, the Agency will rely on the Office of Pollution Prevention and Toxics (OPPT) model, Exposure and Fa te Assessment Screening Tool (EFAST, version 2.0, or EFAST2, 2007). From this m odel, the Agency will use the “Down-theDrain” module, which is designed for releases to domestic wastewater treatment. It is suitable for all the sources of cyfluthrin and beta -cyfluthrin that c ould potentially be exposed through a “down-the-drain” scenar io. The model provides screening level estimate concentrations of chemicals in su rface water that may result from household uses and the disposal of consumer products into wastewater usi ng a few simple input parameters (production volume and fraction of the chemical removed during wastewater treatment) (please, refer to Section 7.9.1 for data being required for this analysis; a POTW treatability study is being required for these chemicals).

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 cyfluthrin and beta -cyfluthrin, which can be applied as a dust, this includes the amount 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 drift61 (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 , cyfluthrin and beta

cyfluthrin appear to have a potential to bioaccumulate in aq uatic organisms, based on its high K OW (9.33 x 10 5 ) and persistence in water and sediments. Du e to its metabolism and relatively rapid depuration, it a ppears that cyfluthrin and beta -cyfluthrin have a low likelihood to biomagnify in aqua tic and terrestrial organisms ( i.e. , a form of bioaccumulation where concentrations increase from prey to predators due to dietary exposure). However, this potential has not been quantified. The potential for bioaccumulation and biomagnification of cyfluthrin and beta -cyfluthrin in aquatic food webs will be examined in the risk assessment. Because cyfluthrin and beta -cyfluthrin have a fairly high K OW (9.33 x 10 5 ) and the chemical may be persistent in water and sediments, there is a potential for bio accumulation. The maximum bioconcentration factor was 854x for whole fish and depuration rate is moderate (half depuration time of 3 days, MRID 00143143). Bioaccumulation will be assessed using the results from bioaccumulation in fish studies, as well as the (K OW (based) Aquatic BioAccumulation Model (KABAM, v.1.0, 2009), adjusting for biotransformation rates. KABAM is used to estimate potential bioaccumul ation of hydrophobic organic pe sticides in freshwater aquatic ecosystems and risks to mammals and birds consuming aquatic organisms which have bioaccumulated these pesticides. Cu rrently, EFED does not have the modeling capabilities to quantitatively evaluate bioaccu mulation and biomagnification in terrestrial food webs 5 . Therefore, EFED will address these exposure routes qualitatively.

7.3. Measures of Effect

Ecological effects data are used as m easures 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

5 USEPA. 2009a. SAP Minutes No. 2009-01. A Set of Scientific Issues Being Considered by the Environmental Protection Agency Rega rding: Selected Issues Associated with the Risk Assessment Process for Pesticides with Persistent, Bioaccumulative an d Toxic Characteristics October 28 - 31, 2008. FIFRA Scientific Advisory Panel Meeting, Held at the Environmental Protection Agency Conference Center, Arlington, Virginia ( http://epa.gov/oscpmont/sap/meetings/2008/october/minutes.pdf )62 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-listedanimals 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 e ffects of cyfluthrin and beta -cyfluthrin on non-target animals is also collected from the Ecologica l Incident Information System (EIIS). The EIIS is a database containing adverse effect (typically mortality) reports on non-target organisms where such effects have been associated with the use of pesticides. Information on incidents involving avian spec ies is also provided through the Avian Monitoring Information System (AIMS), whic h 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 cyfluthrin and beta -cyfluthrin to birds is similar to terrestrial-phase amphibians and reptiles. The same assump tion is made for fish and aquatic-phase amphibians.

7.4. Integration of Exposure and Effects

Risk characterization is the integration of exposure and ecological e ffects characterization to determ ine 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 cyfluthrin and beta -cyfluthrin’s uses, as directed on the label, have the potential to cause adverse direct or indirect effects to non-targ et organisms. In addition, incident data from the EIIS will be consid ered as part of the risk characterization.

7.5. Deterministic and Probabilistic Assessment Methods63The 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

Consisten t 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 cyfluthrin and beta -cyfluthrin. This assessment will be conducted in accordance with the Overview Document (USEPA 2004), provisions of the ESA, and the Services’ Endangered Species Consultation Handbook (USFWS/NMFS, 1998). No previous endangered species assessme nt has been conducted for cyfluthrin or beta -cyfluthrin.

The assessment of effects associated w ith the registration of cyfluthrin and beta

cyfluthrin is based on an action area. The action area is considered to be the area directly or indirectly affected by the federal acti on, as indicated by the exceedance of Agency Levels of Concern (LOCs) used to evaluate direct or indirect e ffects. The Agency’s approach to defining the action area under th e provisions of the Overview Document (USEPA 2004) considers the results of the risk assessm ent process to establish boundaries for that action area with the understa nding that exposures below the Agency’s defined LOCs constitute a no-effect threshol d. For the purposes of this assessment, attention will be focused on the footprint of the action ( i.e. , the area where cyfluthrin and beta -cyfluthrin applicati on occurs), plus all areas where offsite transport may result in potential exposure that exceeds the Agency’s LOCs. Specific measures of ecological effect that define the action area for listed sp ecies include any direct and indirect effects and/ or potential modification of its critical habitat, in cluding reduction in survival, growth, and reproduction as well as the full suit e of sub-lethal effects available in the effects literature. Therefore, the action area extends to a point where environmental exposures are below any measured lethal or su b-lethal effect threshold for any biological entity at the whole organism, organ, tissue, and/ or cellular level of organization. In situations where it is not possible to determ ine the threshold for an observed effect, the action area is not spatially limited and is assumed to be the entire United States.

Currently, EFED does not assess risk to non-targ et insects. Results of acceptable studies are used for recommending appropriate labe l precautions. Based on the results of a single study in honey bees (LD 50 of 0.037 μ g a.i./bee, MRID 00153638), cyfluthrin is classified as highly toxic on an acute contact basis. This study suggests that the acute toxicity to non-target bene ficial endangered insects may also be of concern should
exposure occur.

Toxicity data are not available for terrestrial plants, and risks associ ated with cyfluthrin and beta-cyfluthrin exposure to terrestrial pl ants cannot be assessed. In the past, it had64 been indicated that a review of cyfluthrin and beta-cyfluthrin’s m ode of action (neural toxin) suggested that direct toxicity to plan ts would not be an issue of concern. However, incidents involving terrestrial plants have b een reported to the Agency. These data are requested, according to the Part 158 data requirements.

7.7. Drinking Water Assessment

A drinking water ass essment will be conducte d to support future human health risk assessments of cyfluthrin and beta -cyfluthrin should it be required and based on the newly submitted environmental fate results. The drinking water assessment will incorporate model estimates of cyfluthrin and/ or beta -cyfluthrin in su rface and ground waters. Concentrations in surface waters wi ll be estimated using FQPA Index Reservoir Screening Tool (FIRST, v.1.1.1, 12/18/07) (or su bsequently using PRZM/ EXAMS, with the Index Reservoir – for description see above – if refinements ar e required). Ground water estimates of concentrations will be obtained 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 P rogram (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, and or thyroid (E, A, or T) hormonal 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.

Cyfluthrin is among the group of 58 pesticide ac tive ingredients on the initial list to be screened under the EDSP. The Agency will review the EDSP Tier 1 data and any “other scientifically relevant information” submitted in response to test orders. Based on this review the Agency will determine the need fo r additional testing. For further information on the status of the EDSP, the policies and pro cedures, the list of 67 chemicals, the test65 guidelines and the Tier 1 sc reening battery, please refer to the following website: http://www.epa.gov/endo/

.

7.9. Preliminary Identification of Data Gaps

7.9.1. Fate

After evaluation of the available data for cyfluthrin and beta

- cyfluthrin, the following data gaps for registration review have been identified.

835.4100 Aerobic Soil Metabolism – The Agency has aerobic soil metabolism studies performed in two soils for fluorophenyl-labeled cyfluthrin; no data are available with cyclopropyl-labeled cyfluthrin. A study perfor med in two soils should be submitted for cyfluthrin (at least, one of which shoul d be conducted with cyclopropyl-labeledcyfluthrin). In addition, a study shou ld be performed in four soils for beta -cyfluthrin. The data requirement is being required for beta -cyfluthrin as per current draft guidance provided in the EFED Interim Policy for Stereoisomeric Pesticides (10/26/00), 6 that indicates that “...an aerobic soil metabolism study (GLN 162-1/835.3300) is required as part of the minimal data set for enantiomeric enriched mixtures.” (Note that the current guideline number for the aerobic soil metabo lism studies is 835.4100.) At this time, these data are not available to the Agency. Furthermore, there is evidence in the literature that the degrad ation of cyfluthrin and beta -cyfluthrin may be enantioselective (Qin et al. 2006, Li et al. 2008). Aerobic soil metabolism 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 Guidel ines – OCSPP (formerly OPPTS) Guideline 835.4100 & 835.4200). For all metabolism studies, domestic soils are preferred.

835.4200 Anaerobic Soil Metabolism – The available supplemental anaerobic soil metabolism study, conducted on cyfluthrin, wa s performed with onl y one soil and for a period of roughly one month of anaerobic incubation. A new study is required. Anaerobic studies with one soil type are ge nerally sufficient for the evaluation of transformation pathways. Rates of transforma tion should be determined in at least three additional soils (from Fate, Transport and Transformation Test Guidelines – OCSPP (formerly OPPTS) Guideline 835.4100 & 835.4200). For all metabolism studies, domestic soils are preferred.

835.4300 Aerobic Aquatic Metabolism – Two soil/ sediment systems are available that were conducted with cyclopropyl-labeled cyflut hrin. The studies available that were conducted with fluorophenyl-labeled cyfluthrin provide only a minimum supplemental information. 7 A study should be conducted utilizing fluoroph enyl-labeled beta -cyfluthrin

6 Available at url http://www.epa.gov/oppefed1/ecoris k_ders/stereoisomer_policy.htm

. 7 The following problems were observed in the studies: the amount of parent material at the first sampling interval was too low, studies were conducted at abov e the solubility limit, and the study was not performed in accordance with FIFRA GLP standa rds. When conducting the new st udy, the registrant should avoid these problems.66 on one sediment system of marine origin. According to the OCSPP (formerly OPPTS) Fate, Transport and Transf ormation Test Guidelines (835.4300 & 835.4400)...“At least two sediments and their associated waters ar e used for both the aerobic and the anaerobic studies respectively...However , there may be cases where more than two aquatic sediments should be used, for example, for a ch emical that may be present in freshwater and/or marine environments. Sediments should be representative of intended use sites.” Since both cyfluthrin and beta -cyfluthrin have the potential for use near estuarine/ marine areas, the required sediment system should be from estuarine/ marine environment. For the metabolism studies, domestic sediments are preferred.

835.4400 Anaerobic Aquatic Metabolism – No study has been submitted. The study is required, and it should be conducted on beta -cyfluthrin. Three sediment systems are required, one of which should be of marine or igin (see guideline requirement above). For the metabolism studies, domestic sediments are preferred.

835.1230 Mobility Adsorption/ Desorption – The available study was performed at a single concentration and no Fre undlich correlations or isotherms are available. A new study is required. According to OCSPP (formerly OPPTS) Fate, Transport and Transformation Test Guideline (835.1230), the main portion of the adsorption/ desorption study is for the “Determination of Freundlic h adsorption isotherms to determine the influence of concentration on the extent of adsorption on soils.” The available study indicated that cyfluthrin is relatively immobile in the various soils tested (K OC ≥ 73,500).

Environmental 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 cyfluthrin and beta -cyfluthrin indicate that there is high concern for acute and chronic toxicity to aquatic animals. Certain scen arios may have triggered acute and chronic levels of concern for freshwat er and/ or estuarine/ marine aquatic invertebrates and/ or for fish and/ or organisms living in the benthos. Therefore, ECMs for water and sediment are required in a ddition to the ECM for soil. The ECMs should include parent and those resi dues found in the laboratory st udies that exceeded 10% of the applied. Based on the available data at this time, the following appear to be the residues of concern for each media, but this could change, based upon the results of new environmental fate studies: Soil, Water and Sediment – cyfluthrin, beta -cyfluthrin, FPB-acid, FPB-ald and DCVA 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 (MRID 41511301, published in the Agency’s ECM website), 8 that could quantify cyfluthrin in water and sediment. In

8 Available at url: http://www.epa.gov/oppbea d1/methods/ecm index.htm67 addition, there is one ECM and ILV that quant ifies cyfluthrin and other pyrethroids in sediments (MRID 47053001 and 47053002). The Agency will verify the suitability of these methods and the appropriateness of their levels of quantization. At this time, no methods have been identifi ed for the analysis of beta -cyfluthrin. A full description of the method validation procedures performed by an independent laborat ory should also be submitted. It should include the following information (Corbin et al. 2006): (a) Recovery level(s) of the test compound(s) from the so il, water and sediment (substrates) at various relevant fortification level(s) using the re sidue analytical met hodology; (b) a validated method sensitivity level; (c) results of the st udy and statistical test applied, including a stepwise presentation of the procedure for cal culating percent recovery from the raw data; (d) all the data/ information necessary to inde pendently verify the results; (e) summary of the results; and, (f) discussion and conclusi ons of the results.

Other data needs:

Leachability from Treated Wood – A study is required. It should be conducted according to the American Wood Preserve rs Association Standard Method of Determining the Leachability of Wood Preserva tives (E11-06). It is strongly preferred that the registrant provided a protocol to be evaluated by the Agency prio r to conducting the study.

POTW Effluent Monitoring – Request any existing or ongoing POTW effluent monitoring data for the pyrethroids be submitted to the Agency.

POTW Treatability Study – The Agency is anticipating requiring a bench scale study of waste water treatment, to assess the percentage removed in the biosolids by the treatment, the amount that would degrade during treatmen t, and the amount that would remain in the waste water. These data would be used to inform removal percentages by waste water treatment, which is an input to the Exposure and Fate Asse ssment Screening Tool’s (EFAST) down-the-drain module. The Office of Pesticide Program s will continue to confer with the Office of Water with the goa l of refining our down-the-drain assessment for registration review.

Table 7.1 lists the status of the environmental fa te data requirements for cyfluthrin and beta -cyfluthrin.

Table 7.1. Summary of Envi ronmental Fate Data Requi rements for Cyfluthrin and Beta -cyfluthrin

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 00131493, 00137539, 45022101 No68 Table 7.1. Summary of Envi ronmental Fate Data Requi rements for Cyfluthrin and Beta -cyfluthrin

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)?

835.2240 Photodegradation in Water 1,2 Yes 00149595, 45022102 No

835.2410 Photodegradation on Soil 1,2 Yes 00137543, 00157043 No

835.2370 Photodegradation in Air 1,2 No Not Available No

Metabolism Studies-Lab :
835.4100 Aerobic Soil 1,2 Yes 00131494 Yes 2

835.4200 Anaerobic Soil 1,2 Yes 00131494 Yes 3

835.4300 Aerobic Aquatic 1,2 No 46824101 Yes 4

835.4400 Anaerobic Aquatic 1,2 No Not Available Yes 5

Mobility Studies :
835.1230 Leaching – Adsorption/ Desorption 1,2 Yes 00131495, 00137544, 43424901, 45022103 Yes 6

835.1410 Volatility (Lab) 1,2 No Not Available No
835.8100 Volatility (Field) 1,2 No Not Available No

Dissipation Studies-Field :

835.6100 Terrestrial Field Dissipation 1,2 Yes AN 259211, 44822901, 42794801 No 7

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

§158.1100 SPRAY DRIFT 201-1 Droplet Size Spectrum 1,2 Yes AN 255336 No 8

202-1 Drift Field Evaluation 1,2 Yes AN 255336 No 8

Other Studies :69 Table 7.1. Summary of Envi ronmental Fate Data Requi rements for Cyfluthrin and Beta -cyfluthrin

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)?

Environmental Chemistry Methods (ECMs) and Independent Laboratory Validations (ILVs) 1,2 Yes 41511301, 47053001, 47053002 Yes 9

Leachability from Treated Wood 1.2 No Not Available Yes 10

POTW Effluent Monitoring and POTW Treatability Study 1.2 No Not Available Yes 11

1. Use Patterns: 1=Terrestrial/Food; 2=Terrestrial/Feed. 2. A study performed in two soils should be submitted for cyfl uthrin. In addition, a study should be performed on four soils for beta -cyfluthrin. The data requirement is being required for beta -cyfluthrin as per current draft guidance provided in the EFED Interim Policy for Stereoisomeric Pesticides. 3. Data are required for cyfluthrin on four soils utilizing fluorophenyl- and cyclopropyl-labeled cyfluthrin, as per current guidance. 4. A study should be conducted utilizing fluorophenyl-labeled beta -cyfluthrin on one sediment system of estuarine/ marine origin. 5. A study is required for beta -cyfluthrin. 6. The available study was conducted at only one concentration and a Freundlich isotherm could not be drawn. A new study is required. 7. One of the studies is currently in review. 8. Data requirement covered by submission of the Spray Drift Task Force. 9. The data requirement remains unfulfilled for cyfluthrin, pending evaluation of three available studies. No data have been identified for beta -cyfluthrin. 10. It is strongly preferred that the registrant provided a protocol to be evaluated by the Agency prior to conducting the study. 11. Request any existing or ongoing POTW effluent monitoring data. Further, the Agency is anticipating requiring a bench scale study of waste water treatment, to assess the percentage removed in the biosolids by the treatment, the amount that would degrade during treatment, and the amount that would remain in the waste water.

7.9.2 Effects

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

Cyfluthrin is part of the E ndocrine Disruptor Screening Prog ram; certain data has been required for the chemical under the program (DCI issued on 11/19/ 09; 90-day response by 02/27/10; order due date 11/19/11).

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 to70 identify the potential of a chemical substan ce to interact with th e estrogen, androgen, and or thyroid (E, A, or T) hormonal 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.

Cyfluthrin is among the group of 58 pesticide ac tive ingredients on the initial list to be screened under the EDSP. The Agency will review the EDSP Tier 1 data and any “other scientifically relevant information” submitted in response to test orders. Based on this review the Agency will determine the need fo r additional testing. For further information on the status of the EDSP, the policies and pro cedures, the list of 67 chemicals, the test guidelines and the Tier 1 sc reening battery, please refer to the following website: http://www.epa.gov/endo/

.

Guideline Number: 850.2100 Study Title: Passerine Acute Avian Oral An acute avian oral study was received fo r bobwhite quail. The Agency updated its data requirements in 40 CFR Part 158 (October 26, 20 07) to include an acute oral toxicity study for both a passerine species and either a waterfowl or an upland game species. Prior to starting toxicity tes ting, a protocol will need to be provided for review. Many passerine species utilize agricultural fields, forests, re sidential areas and surrounding areas, and, therefore, have the potential to be exposed to pes ticides used in agricultural, forest, and residential settings. It is likely that, for most pe sticide use patterns, passerines are more likely to be exposed to pesticides than upland game species and waterfowl. Passerines are smaller in size and generally 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: 850.2300 Study Title: Avian Reproduction Study (Mallard duck only) No acceptable data on reproductive toxicity to the most sensitive bird species has been submitted (mallard duck). The most sensitive study resulted in a nondefinitive NOAEC (<250 ppm) and both submitted studies had issues with control performance. A chronic risk assessment for birds is needed based on cy fluthrin’s use patterns and potential impact on birds. The avian reproduction toxicity study is justified for cyfluthrin because 1) the avian reproduction studies for both waterfowl and upland game bird species are standard data requirements for all outdoor terrestrial us e patterns, 2) evidence of chronic toxicity71 to mammals indicates possible ch ronic toxicity in birds, a nd 3) cyfluthrin use pattern indicates that chroni c exposure is likely.

Guideline Number: 850.1025 Study Title: Oyster Acute Toxicity (saltwater, cyfluthrin TEP only) Guideline Number: 850.1035 Study Title: Mysid Acute Toxicity (saltwater, cyfluthrin TEP only) Cyfluthrin and beta-cyfluthrin have the poten tial to enter estuarin e/marine water bodies based on current usage patterns that include coastal areas (see Fig. 3.1 ). Cyfluthrin technical is very highly toxic to estuarine/marine fish and invertebrates on an acute basis, but no information is available for cyfluthrin TEP effects on estuarine/marine species.

Testing on Typical e nd-use products (TEP) According to the Part 158 data requirement s, testing on the typical end-use product may be required for aquatic toxicity tests when any of the following conditions exist:

1. The end-use product will be introduced directly into the a quatic environment. 2. The maximum expected environm ental concentration or estimated environmental concentration in the aquatic environment is greater than or equal to one-half the LC 50 or EC 50 of the TGAI. 3. An ingredient in the end-use formula tion other than the active ingredient is expected to enhance the toxicity of the active ingredient or cause toxicity to aquatic organisms.

Previous assessments on cyfluthrin indi cate that the expected environmental concentrations in aquatic environments are well above acute 50% mortality levels for all estuarine/marine invertebrate species test ed. Based on preliminary calculations (see Appendix D ), the peak aquatic EEC is 1.62 μg ai/L using the PRZM/EXAMS MS cotton scenario. In estuarine/marine tests conducted with cyfluthr in technical, the lowest 96- hour LC 50 was 4.05 μg/L for sheepshead minnow, 0.0022 μg/L for mysid shrimp and 2.69 μg/L for the eastern oyster. Therefore, cyfluthrin fulfills the second requirement (above) for TEP studies with all tested estuar ine/marine invertebrate species, but not estuarine/marine fish.

A Typical End-Use Product is defined in the Pesticide Assessment Guidelines Subdivision J Hazard Evaluation: Nontarget plants on Part 120-2(1) on Page 18 as “a pesticide product that is representati ve of a major formulation category ( e.g ., emulsifiable concentrate, granular product, we ttable powder) and pesticide group ( e.g ., herbicide, fungicide, insecticide etc .) and contains the active ingredie nt of the applicant’s product.” (Holst and Ellwanger, 1982)

Page 5 of the Pesticide Assessment Guidelines S ubdivision J Hazard Evaluation: Nontarget plants

, provides additional information on what TEP data should be tested for toxicity testing in the following excerpt.

“The Agency seeks to avoid imposi ng a burden of dupli cative testing on72 applicants for registration. Therefore, where 40 CFR Part 158 specifies that the test substance should be a representa tive end-use product, testing may be performed using the formulation in questi on (end-use product be ing registered) or similar, yet representative, end-use product. It is not necessary to repeat the test using other similar products.” (Holst and Ellwanger, 1982).

When TEP data are requested, data should be submitted for the different formulations,
e.g ., wettable powder, emulsifiable concentrate, granular, along with a rationale as to why the TEP is representative of other similar e nd-use products. Acute aqua tic toxicity studies conducted with the Typical End-Use Product (TEP ) may be used to assess effects as a result of exposure to spray dr ift only and reflect potential e ffects from a brief exposure to the formulation. Therefore, appropriate TEPs s hould be selected from formulations that are registered for agricult ural uses, not residential.

Guideline Numbers: Non-guideline Study Title: Aquatic Invertebrate Acute Toxicity ( Hyalella azteca ) Available information in the Agency ECOTOX database indicates that the freshwater amphipod, Hyalella azteca , is substantially more sensitive to pyrethroids than Daphnia
magna , the commonly tested freshwater inverteb rate. Information on the acute toxicity of cyfluthrin to Hyalella azteca was not identified in this problem formulation. Therefore, in order to ensure that risk to sensitive aquatic inverteb rates are appropriately quantified, additional acute toxicity testing of Hyalella azteca is needed (water column exposure, not sediment-spiked)

. Guideline Number: Non-guideline Study Title: Whole sediment: chroni c 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 cyfluthrin, available information indicates that benthic organisms may be exposed via run-off or spra y drift applications used in agricultural, forest, and residential settings. Ba sed on preliminary calculations (see Appendix D ), the peak sediment porewater EECs predicted for cyfluthrin (0.048 μg a.i./L) exceeds 0.1 of the most sensitive acute LC/EC 50 (0.0022 μg/L for mysid shrimp), which satisfies one of the criteria for requiring chronic whole sedime nt toxicity testing under 40 CFR Part 158. Further, the expected half-life of cyflut hrin in sediment (73.5-94.8 for aerobic soil metabolism and 32.9-42 days for aerobic aquatic me tabolism) is substantially greater than 40 CFR Part 158 criterion of 10 days. The th ird set of trigger cr iteria for requiring chronic testing (K d > 50, or log K OW >3 or K OC > 1000) is also met for cyfluthrin ( e.g. , K d values are 974-1793, log K OW is 6, and K OC values are 69900-180300). In addition, chronic effects were also seen in all aquati c taxa tested at leve ls ranging from 0.00040 – 0.63 μg a.i./L. Finally, the potential for pers istent exposure from cyfluthrin in sediment is also indicated by open literatur e studies on pyrethroids (Weston et al. 2005, Amweg et al. 2006 and Ding et al . 2009).

For sediment studies involving pyrethroids, chronic whole sediment tests on Hyalella
azteca , Chironomus tentans , and Leptocheirus plumulosus are requested. Although both are freshwater species, Hyalella and Chironomus differ substantially in their ecological73 niche ( i.e. , epibenthic v. infaunal species), phy siology, and there is some evidence suggesting Hyalella is among the more sensitive invert ebrates to some pyrethroids based on water column tests (Anderson et al. 2006, Maund et al. 2002). Cyfluthrin has the potential to enter estuarine/marine water bodies based on current usuage patterns that include coastal areas. Therefore, testing is required for Leptocheirus plumulosus , an estuarine/marine sediment-dwelling invertebrate species. The previously-submitted 28- day sediment test for cyfluthrin with Leptocheirus plumulosus (MRID 46591506) does not include reproductive endpoi nts, and does not fulfill this data requirement for estuarine/marine benthic invertebrates.

Guideline Numbers: 850.4100 and 850.4150 Study Title: Vegetative vigor and Seedling emergence, Tier I/ Tier II No acceptable toxicity data are currently available to assess the risk of cyfluthrin to nontarget terrestrial plants. Since cyfluthrin ha s residential outdoor uses , vegetative vigor and seedling emergence studies are re quired. Additionally, three in cidents have been reported to the Agency where cyfluthrin was identifie d as the possible – highl y probable cause of phytotoxic damage. Phytotoxicity data are need ed to evaluate the level of pesticide exposure to non-target terrestrial and aquatic plants and to as sess the impact of pesticides on endangered and threatened plants.

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

In addition to the above mentioned data requirements for cyfluthrin, the following are required for beta -cyfluthrin as per the EFED Interim Policy for Stereoisomeric Pesticides, 9 which says the following:

“OPP requires the following minimal data set using species and conditions (including testing laboratories) that are identical to those for the data submitted for the previous racemic mixture. If the toxicity values are substantially similar for the racemic and enantiomeric enriched mixture and do not result in significantly greater potential risk, then no additional ecotoxicity data are needed. If, however, the toxicity data for the racemic and enantiomeric enriched mixture differ significantly and suggests that the enriched mixture poses a significantly greater risk, then additional ecotoxicity data may be required on a case-by-case basis.”

The data required in the interim policy is as follows:

Avian

9 Available at http://www.epa.gov/oppefed1/ecorisk _ders/stereoisomer_policy.htm

.74  Guideline 850.2100 - Acute Avian Oral -Inspection of the available results for cyfluthrin shows that the acute endpoint (LD 50 ) was >5000 mg/kg bw for both mallard duck and bobwhite quail (p ractically non-toxic).

o Since cyfluthrin shows low toxicity towards bobwhite quail and mallard species, EFED is not requiring the data for beta -cyfluthrin at this time.

 Guideline 850.2300 - Avian Reproduction - required if birds are more sensitive than mammals.

o Preliminary inspection of available data for cyfluthrin indicates that birds are less sensitive to the chemical compared to mammals. Studies examining beta -cyfluthrin reproductive eff ects to mammals have been submitted. Therefore, at this time, no additional data are required for beta

cyfluthrin.

Aquatic

 Guideline 850.1075 or 850.1010 – Acute Fres hwater Fish Toxicity or Acute Freshwater Invertebrate Toxicity - Several tests with beta -cyfluthrin technical were submitted for freshwater fish, freshwater invertebrates and estuarine/marine invertebrates. Two studies with mysids were determined to be acceptable. All other aquatic studies with beta -cyfluthrin were deemed supplemental.

o The most sensitive species based on registrant-submitted data is Mysidopsis bahia . At this time, no additional data are required for beta

cyfluthrin effects on mysids.

 Guideline 850.1400 or 850.1300/ 850.1350 - Fish Early Life Stage or Invertebrate Life Cycle - test most sensitive species from previous studies with cyfluthrin.

o Required for beta -cyfluthrin. Preliminary inspection of the results indicates that the most sensitive species is Mysidopsis bahia

.
Nontarget Plant

 Guideline 850.4100 or 850.4150 - Seedling Emergence or Vegetative Vigor Test most sensitive monocotyledon and dicotyledon based on results of cyfluthrin terrestrial plant toxicity tests. No data is available for cyfluthrin.

o Required for beta -cyfluthrin.

 Guideline 850.4400 - Aquatic Plant Growth, Lemna gibba No data is available for cyfluthrin.

o Required for beta -cyfluthrin.

 Guideline 850.5400 - Aquatic Plant Growth, algae –The available acceptable study conducted on cyfluthrin shows that the EC 50 was non-definitive (>181 μg a.i./L).

o Since the highest level tested is much greater than the preliminary peak aquatic estimated exposure concentra tion (EEC) (1.62 μg a.i./L based on the PRZM/ EXAMS MS cotton scenario), no additional nonvascular aquatic plant data are re quired at this time for beta -cyfluthrin.75 Table 7.2 lists the status of the ecological eff ects data requirements for cyfluthrin and beta -cyfluthrin. All additi onal data requests are for cyfluthr in only, with the exception of invertebrate life cycle, seed ling emergence, vegetative vigor and vascular aquatic plant growth studies required for beta -cyfluthrin (see footnote section of table for each of these data requests).

Table 7.2. Ecological Effects Data Requirements for Cyfluthrin and Beta -cyfluthrin

Data Requirement Use Pattern 1 Does EPA Have Data To Satisfy This Requirement?

(Yes, No, or

Partially) Bibliographic Citation (MRID) Must Additional

Data Be Submitted Under FIFRA

3(c)(2)(B)?

§158.490 WILDLIFE AND AQUATIC ORGANISMS

71-1(a) Acute Avian Oral, Quail/Duck/Passerine 1, 2 Partially 00073629 Yes, passerine study
71-2(a) Acute Avian Diet, Quail 1, 2 Yes 00131500 No 2

71-2(b) Acute Avian Diet, Duck 1, 2 Yes 00131501 No 2

71-3 Wild Mammal Toxicity 1, 2 NA

71-4(a) Avian Reproduction Quail 1, 2 Yes 00152829, 00152830 No

71-4(b) Avian Reproduction Duck 1, 2 No 00015782, 00014533 Yes 3

71-5(a) Simulated Terrestrial Field Study 1, 2 NA
71-5(b) Actual Terrestrial Field Study 1, 2 NA
72-1(a) Acute Fish Toxicity Bluegill 1, 2 Yes 00131503, 45426707 No

72-1(b) Acute Fish Toxicity Bluegill (TEP) 1, 2 Yes 41558001 No 4

72-1(c) Acute Fish Toxicity Rainbow Trout 1, 2 Yes 00131502, 45426705 No

72-1(d) Acute Fish Toxicity Rainbow Trout (TEP) 1, 2 Yes 41558002 No

72-2(a) Acute Aquatic Invertebrate 1, 2 Yes 00131504, 45426701, 42605801 No

72-2(b) Acute Aquatic Invertebrate (TEP) 1, 2 Yes 41558003 No
72-3(a) Acute Est/Mar Toxicity Fish 1, 2 Yes 00146485 No
72-3(b) Acute Est/Mar Toxicity Mollusk 1, 2 Yes 00158783 No
72-3(c) Acute Est/Mar Toxicity Shrimp 1, 2 Yes 00149598, 40069501, 45426704, 45426709 No

72-3(d) Acute Est/Mar Toxicity Fish (TEP) 1, 2 No NA No 576 Table 7.2. Ecological Effects Data Requirements for Cyfluthrin and Beta -cyfluthrin

Data Requirement Use Pattern 1 Does EPA Have Data To Satisfy This Requirement?

(Yes, No, or

Partially) Bibliographic Citation (MRID) Must Additional

Data Be Submitted Under FIFRA

3(c)(2)(B)?

72-3(e) Acute Est/Mar Toxicity Mollusk (TEP) 1, 2 No NA Yes 5

72-3(f) Acute Est/Mar Toxicity Shrimp (TEP) 1, 2 No NA Yes 5

72-4(a) Early Life Stage Fish 1, 2 Yes 41450401 No

72-4(b) Life Cycle Aquatic Invertebrate 1, 2 Yes 00132761, 00162969 Yes 6

72-5 Life Cycle Fish 1, 2 Yes 00151442 No
72-6 Aquatic Organism Accumulation 1, 2 No NA No
72-7(1) Simulated Aquatic Field Study 1, 2 No NA No
72-7(b) Actual Aquatic Field Study 1, 2 No NA No

Whole sediment: acute freshwater invertebrates 1, 2 Yes 46591507 No 7

Whole sediment: acute marine invertebrates 1, 2 Yes 46591506 No 7

Whole sediment: chronic invertebrates freshwater & marine 1, 2 No NA Yes 8

Non-guideline Aquatic Invertebrate Acute Toxicity ( Hyalella ) 1, 2 No NA Yes

§158.540 PLANT PROTECTION

122-1(a) Seed Germ, Seedling Emergence 1,2 No NA Yes 9

122-1(b) Vegetative Vigor 1, 2 No NA Yes 9

122-2 Aquatic Plant Growth 1, 2 No 43984901 Yes 10

124-1 Terrestrial Field Study 1, 2 No NA No

124-2 Aquatic Field Study 1, 2 No NA No

§158.490 NONTARGET INSECT TESTING

141-1 Honey Bee Acute Contact 1, 2 Yes 00153638 No
141-2 Honey Bee Residue on Foliage 1, 2 No NA No

141-5 Field Test for Pollinators 1, 2 No NA No

§158.630 AQUATIC ORGANISMS TESTING

850.1730 Bioaccumulation in Fish 1, 2 Yes 00143143 No77 Table 7.2. Ecological Effects Data Requirements for Cyfluthrin and Beta -cyfluthrin

Data Requirement Use Pattern 1 Does EPA Have Data To Satisfy This Requirement?

(Yes, No, or

Partially) Bibliographic Citation (MRID) Must Additional

Data Be Submitted Under FIFRA

3(c)(2)(B)?

1 Use Patterns: (1=Terrestrial/Food; 2=Terrestrial/Feed).
2 Original review classified the study as acceptable, completed in 1983 by W. Faatz. Study not required at this time as the study is acceptable based on a cursory review, but may be required pending additional evaluation of the data.
3 A bluegill toxicity test with an end-use product has been submitted for cyfluthrin, but the study was classified as supplemental. However, TEP data has been submitted for the mo st acutely sensitive fish species, rainbow trout so the data requirement is waived.
3 Both submitted chronic studies for mallard duck are classified as supplemental. Therefore, a new study is requested.
4 Based on preliminary calculations (see Appendix D ), the peak aquatic EEC is 1.62 μg a.i./L using the PRZM/ EXAMS MS cotton scenario. In estuarine/marine tests conduc ted with cyfluthrin technical, the lowest 96-hour LC 50 was 4.05 μg/L for sheepshead minnow, 0.0022 μg/L for mysid shrimp and 2.69 μg/L for the eastern oyster. Therefore, cyfluthrin fulfills the requirements for requesting TEP studies with all tested es tuarine/marine invertebrate species, but not estuarine/marine fish (According to Part 158, for TEP data requests, the maximum expected environmental concentration or estimated environmental concentration in the aquatic environment is greater than or equal to one-half the LC 50 or EC 50 of the TGAI).

5 Data are required for beta -cyfluthrin.
6 Data in review. According to current Part 158 guidelines, only chronic sediment studies would be requested for cyfluthrin.

7 Data required for chironomids, Hyalella azteca and Leptocheirus plumulosus

. 8 Studies are required for cyfluthrin and beta -cyfluthrin. For beta -cyfluthrin, the most sensitive monocotyledon and dicotyledon should be tested from tests with cyfluthrin.
9 Aquatic toxicity tests are required for aquatic vascular plant species. A test has been submitted for green algae (acceptable), but the EC 50 was non-definitive (>181 μg a.i./L ). Because the highest level tested is much greater than the preliminary peak aquatic estimated exposure concentration (EEC) (1.62 μg ai/L based on the PRZM/EXAMS MS cotton scenario), no additional nonvascular aquatic plant data is re quested at this time. A study should be conducted on beta

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Rexrode, M. and J.L. Meléndez. 2003. EF ED’s rationale for choosing Cypermethrin, Esfenvalerate, Bifenthrin, and Cyfluthrin for sediment testing as discussed with the Pyrethroid Working Group (PWG). Memorandum to M. Johnson & G. LaRocca dated 12/22/03. Environmental Fate and Eff ects Division, OPP, OPPTS, USEPA.

Shehata, A., Abdell-All, A. Farag, M. Samaan and Y. Mohareb. 1987. Some factors influencing persistence, hydrolysis, downward movement and leachability of cyfluthrin in Egyptian soils. Annals Agricu ltural Science, 32(3): 1677-1687.

Smith, S., G.H. Willis, and C.M. Cooper. 1995. Cy fluthrin Persistence in Soil as Affected by Moisture, Organic Matter, and Redox Pote ntial. Bull. Environ. Contam. Toxicol. (1995) 55:142-148.

Stout II, D.M., K Bradham, P.P. Egeghy, P. Jones, C.W. Croghan, P.A. Ashley, E. Pinzer, W. Friedman, M.C. Brinkman, M.G. Nishioka and D.C. Cox. 2009. American Healthy Homes Survey: A National Study of Resi dential Pesticides Me asured from Floor Wipes. Environ. Sci. Technol., 2009 , 43, 4294–4300.82 Trimble, A.J, D.P. Weston, J.B. Belde n, and M.J. Lydy. 2009. Identification and Evaluation of Pyrethroid Insecticide Mixtures in Urban Sediments. Environ Toxicol & Chem 26 (8) pp. 1687–1695.

Ureda, N. 2004. Sediment LC 50 Analyses of the Pyrethroid Pesticides Cyfluthrin, Deltamethrin, and Lambda-Cyhalothrin. [Available at url: http://nature.berkeley.edu/classes/es196/projects/2004final/U reda.pdf accessed 04/16/10].

U.S. Environmental Protection Agency. 1998. Guidelines for Ecological Risk Assessment. Risk Assessment Forum, Office of Research and Development, Washington, D.C. EPA/ 630/R-95/002F. April 1998.

U.S. Environmental Protection Agency. 1999. FIFRA Scientific Advisory Panel Meeting, February 23, 1999 held at the Holiday Inn Hotel, Arlington, VA

. SAP Report No. 99- 03A. March 25, 1999. Office of Pesticid e Programs. Available at url: http://www.epa.gov/scipoly/sap/m eetings/1999/022399_ mtg.htm#materials (Accessed December 15, 2009)

U.S. Environmental Protection Agency. 2000. Risk Characterization Handbook. Science Policy Council, U.S. Environmenta l Protection Agency, Washington, D.C. 20460. EPA 100-B-00-002. December 2000.

U.S. Environmental Protection Agency. 2002. Technical Basis for the derivation of Equilibrium Partitioning Sediment Guidelin es (ESGs) for the Protection of Benthic Organisms: Nonionic Organics [Draft]. EPA Document No. 822R02041. October 2002.

U.S. Environmental Protection Agency. 2004. Overview of the Ecological Risk Assessment Process in the Office of Pesticid e Programs, U.S. Environmental Protection Agency. Endangered and Threatened Speci es Effects Determinations. Office of Prevention, Pesticides and Toxic Substances , Office of Pesticide Programs, Washington, D.C. January 23, 2004.

U.S. Environmental Protection Agency. 2005. Generic Format and Guidance for the Level I Screening Ecological Risk Assessm ents Conducted in the Environmental Fate and Effects Division. Office of Pesticide Programs, Washington, D.C. January 24, 2005.

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U.S. Environmental Protection Agency. 2009. A Set of Scientific Issues Being Considered by the EPA Regarding: Evaluati on of the Common Mechanism of Action of Pyrethroid Pesticides. SAP Minutes No. 2009-07. FIFRA SAP Meeting held 6/16/09 in Arlington, VA. Meeting Minutes dated 9/9/09.83 U.S. Fish and Wildlife Service (USFWS) and National Marine Fisheries Service (NMFS). 1998. Endangered Species Cons ultation Handbook: Procedures for Conducting Consultation and Conference Activ ities Under Section 7 of the Endangered Species Act. Final Draft. March 1998.

Weston, D.P., J. You and M.J. Lydy. 2004. Di stribution and Toxicity of SedimentAssociated Pesticides in Agriculture-Domi nated Water Bodies of California’s Central Valley. Environ. Sci. Technol. 2004 , 38, 2752-2759.

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### Environmental Fate Cyfluthrin

161-1 Hydrolysis

MRID Citation Reference

131492 Mobay Chemical Corp. (1983) Synopsi s of Baythroid: The Effects on the Environment--Environmental Chemistry: ?Summary|. (Unpub- lished study received Oct 12, 1983 under 3125-EX-188; CDL: 072003-A)
131493 Sandie, F.; Thornton, J. (1983) Hydr olysis of Baythroid in Sterile, Aqueous Buffered Solutions: 86051. (Unpublished study received Oct 12, 1983 under 3125-EX-188; submitted by Mobay Ch emical Corp., Kansas City, MO; CDL:072003-B)
137539 Sandie, F.; Thornton, J. (1983) Hydr olysis of Baythroid in Sterile, Aqueous Buffered Solutions: 86051. (Unpublished study received Feb 13, 1984 under 3125-351; submitted by Mobay Chemical Corp., Kansas City, MO; CDL:072361-B)
137543 Puhl, R.; Hurley, J.; Dime, R. (1983) Photodecomposition of Bayth- roid-14C in Aqueous Solution and on Soil: 86182. (Unpublished study received Feb 13, 1984 under 3125-351; submitted by Mobay Chemical Corp., Kansas City, MO; CDL:072362-B) 

### 161-2 Photodegradation-water

MRID Citation Reference

149596 Mobay Chemical Corp. (1984) Baythroid: Addition No. 1, January 6, 1984, Brochure No. 1239 to Brochure Entitled: Baythroid: The Effects on the Environment (Dated September 16, 1983):[Attached: 1. Studies on Environmental Fate in Soil; 2. A ccumulation Study in Bluegill Sunfish]. Unpublished study. 171 p.
45022101 Anderson, C. (1986) Degradation Behav ior of (carbon-14)-Cyfluthrin in Natural Water: Lab Project Number: M 113 045-7: 93044. Unpublished study prepared by Bayer AG. 31 p.
45022102 Gronberg, R. (1984) Photodecomposi tion of (Phenyl-UL-(carbon-14))-Baythroid in Aqueous Solution by Sunlight: Lab Project Number: 83R-195: 88598. Unpublished study prepared by Bayer Corporation. 19 p. 

### 161-3 Photodegradation-soil

MRID Citation Reference

137543 Puhl, R.; Hurley, J.; Dime, R. (1983) Photodecomposition of Baythroid-14C in Aqueous Solution and on Soil: 86182. (Unpublished study received Feb 13,85 1984 under 3125-351; submitted by Mobay Chemical Corp., Kansas City, MO; CDL:072362-B)
157043 Chopade, H. (1986) Photodecomposi tion of [Carbon 14] Baythroid on Soil: 88981. Unpublished study prepared by Mobay Chemical Corp. 25 p.


### 162-1 Aerobic soil metabolism

MRID Citation Reference

131492 Mobay Chemical Corp. (1983) Synopsi s of Baythroid: The Effects on the Environment--Environmental Chemistry: ?Summary|. (Unpub- lished study received Oct 12, 1983 under 3125-EX-188; CDL: 072003-A)
131494 Wagner, K.; Neitzel, H.; Oehlmann, L. (1983) Decomposition of Baythroid in Soil under Aerobic and Anaerobic Conditions: ?Sub- mitter| 86052. (Unpublished study received Oct 12, 1983 under 3125-EX-188; prepared by Bayer AG, W. Ger., submitted by Mobay Chemical Corp., Kansas City, MO; CDL:072003-C) 

### 162-4 Aerobic aquatic metab.

MRID Citation Reference

46824101 Dyer, D.; Sabbagh, G. (2006) Cyfluthrin - Aerobic Aquatic Metabolism Overview. Project Number: MEBDP001, M/151/0985/9, SVJ/002. Unpublished study prepared by Bayer Corp. 143 p. 

### 163-1 Leach/adsorp/desorption

MRID Citation Reference

131492 Mobay Chemical Corp. (1983) Synopsi s of Baythroid: The Effects on the Environment--Environmental Chemistry: ?Summary|. (Unpub- lished study received Oct 12, 1983 under 3125-EX-188; CDL: 072003-A)
131495 Obrist, J.; Thornton, J. (1982) Soil Thin-layer Mobility of Bay FCR 1272, Bay SIR 8514, and Bay SSH 0860: 82232. (Unpublished study received Oct 12, 1983 under 3125-EX-188; submitted by Mobay Chemical Corp., Kansas City, MO; CDL:072003-D)
137540 Obrist, J.; Thorton, J. (1982) Soil Thin-layer Mobility of Bay FCR 1272, Bay Sir 8514, and Bay SSH 0860: 82232. (Unpublished study received Feb 13, 1984 under 3125-351; submitted by Mobay Chemi- cal Corp., Kansas City, MO; CDL:072361-D)
137544 Whitfield, S.; Obrist, J. (1983) Soil Th in-layer Mobility of Aged Extracts of Soil Treated with Amethydione, Baythroid, Alsystin, and BAY SLJ 0312: 86158. (Unpublished study received Feb 13, 1984 under 3125-351; submitted by Mobay Chemical Corp., Kansas City, MO; CDL:072362-C)
149596 Mobay Chemical Corp. (1984) Baythroid: Addition No. 1, January 6, 1984, Brochure No. 1239 to Brochure Entitled: Baythroid: The Effects on the Environment (Dated September 16, 1983):[Attached: 1. Studies on86 Environmental Fate in Soil; 2. A ccumulation Study in Bluegill Sunfish]. Unpublished study. 171 p.
40223402 Gronberg, R. (1987) Adsorption of Baythroid to Sandy Loam: Report No. 94541. Unpublished study prepared by Mobay Corp. 13 p.
45022103 Burhenne, J. (1996) Adsorption/Desorp tion of Cyfluthrin on Soils: Lab Project Number: 1310003-8: 107397. Unpublished study prepared by Bayer Corporation. 34 p. 

### 163-3 Volatility - field

MRID Citation Reference

149596 Mobay Chemical Corp. (1984) Baythroid: Addition No. 1, January 6, 1984, Brochure No. 1239 to Brochure Entitled: Baythroid: The Effects on the Environment (Dated September 16, 1983):[Attached: 1. Studies on Environmental Fate in Soil; 2. A ccumulation Study in Bluegill Sunfish]. Unpublished study. 171 p. 

### 164-1 Terrestrial field dissipation

MRID Citation Reference

42794801 Grace, T.; Cain, K. (1990) Dissipati on of Cyfluthrin in California Soils: Lab Project Number: BD830089R01: 100152: ML022101. Unpublished study prepared by Siemer and Associates, Inc. and Net Atlantic, Inc. 389 p.
44822901 Lam, C.; Dehart, B.; Barney, W. (1995) Te rrestrial Field Dissipation of Cyfluthrin on North Carolina Soil, 1992: Lab Project Number: 106949: BD022101. Unpublished study prepared by Bayer Corporation and ABC Laboratories, Inc. 247 p.
42752901 Lin, J. (1993) Field Measurement of Cyfluthrin Fate and Runoff from a Cotton Field in Southern Georgia: Lab Project Number: 103919: BD882303. Unpublished study prepared by Miles Inc. 61 p.
42752902 Lin, J. (1992) Field Measurement of Cyfluthrin Fate and Runoff from a Cotton Field in Benoit, Mississippi: Lab Project Number: 103918. Unpublished study prepared by Miles Inc. 66 p.
ACC 259111 Ash, C.R. 1983 Residues in Arizona soil
ACC 259111 McMullen, P.W. 1983 Residues in Ontario Soil
ACC 259111 Warren, J.W. 1983 Residues in Oregon soil
Acc 259111 Meriweather, B.K. 1983 Residues in Mississppi soil
ACC 259111 Robertson, R.E., 1983 Residues in Kansas soil
ACC 259111 Rogers, W.D. 1983 Residues in Georgia soil
ACC 259111 Fleming, M.O. 1983 Residues in Florida soil
ACC 259111 Price, D.A. 1983 Residues in Florida soil87 

### 165-2 Field rotational crop

MRID Citation Reference

40942701 Leslie, W. (1988) Baythroid--Residues in Field Rotational Cereal Crops: Project ID; BD850086R01: Mobay Project ID: Objective No. 8500. Unpublished study prepared by Cambridge Analytical Assoc- iates, Inc. 136 p.
41190202 Leslie, W. (1989) Baythroid--Residues in Field Rotational Cereal Crops-- Addendum No. 1: Mobay Project ID: Baythroid Objective No. 8500: Report No. 98429-1. Unpublished study prepared by Mobay Corp. 20 p.


### 165-4 Bioaccumulation in fish

MRID Citation Reference

143143 Carlisle, J.; Roney, D. (1984) Bioconcentration of Cyfluthrin (Baythroid) by Bluegill Sunfish: Study Number 83-766- 01. Unpub- lished study prepared by Mobay Chemical Corp. 14 p.
149596 Mobay Chemical Corp. (1984) Baythroid: Addition No. 1, January 6, 1984, Brochure No. 1239 to Brochure Entitled: Baythroid: The Effects on the Environment (Dated September 16, 1983):[Attached: 1. Studies on Environmental Fate in Soil; 2. A ccumulation Study in Bluegill Sunfish]. Unpublished study. 171 p.


### 202-1 Drift field evaluation

MRID Citation Reference

143144 Olson, T. (1984) Evaluation of Spray Drift Following Aerial ULV Applications of Baythroid 2. Unpublished study prepared by Mobay Chemical Corp. in cooperation with Chemonics Industries. 147 p.
Not Available McDaniel, S.G. 

### 850.7100 Data reporti ng for environmental chemistry methods

MRID Citation Reference

47053001 Robinson, N. (2007) Residue Analyt ical Method for the Determination of Residues of Bifenthrin, Cypermethrin, Cy fluthrin, Deltamethrin, Esfenvalerate, Fenpropathrin, Lambda-cyhalothrin and Permethrin in Sediment. Unpublished study prepared by Syngenta Jealotts Hill International. 185 p.
47053002 Reed, R. (2006) Laboratory Validation: Validation of the Residue Analytical Method: Residue Analytical Method for the Determination of Residues of Bifenthrin, Cypermethrin, Cyfluthr in, Deltamethrin, Esfenvalerate, Fenpropathrin, Lambda-Cyhalothrin and Permethrin in Sediment: Final Report. Project Number: MLI/06/02, ML06/1286/PWG. Unpublished study prepared by88 Morse Laboratories Inc. 418 p.



### Environmental Fate Beta -Cyfluthrin

162-4 Aerobic aquatic metabolism

MRID Citation Reference

46824101 Dyer, D.; Sabbagh, G. (2006) Cyfluthrin - Aerobic Aquatic Metabolism Overview. Project Number: MEBDP001, M/151/0985/9, SVJ/002. Unpublished study prepared by Bayer Corp. 143 p.



### Non Guideline Selections
47647801 Hanzas, J.; Stone, C.; Toth, B.; et al. (2008) Bifenthrin and Beta -Cyfluthrin: Quantification of Pyrethroid Runoff Loss es from Treated Turfgrass Under OverIrrigation Conditions and Simulated Rainfall: Final Report. Project Number: 082018, SEI001. Unpublished study prepared by Stone Environmental, Inc., CRG Marine Laboratories, Inc. and Agvise Laboratories. 280 p.



### Ecological Effects Cyfluthrin

71-1 Avian Singl e Dose Oral Toxicity

MRID Citation Reference

131498 Carlisle, J.; Carsel, M.; Lamb, D. (1983) Acute Oral LD50 of Tech- nical Cyfluthrin to Bobwhite Quail: Study No. 83-015-02; 85941. (Unpublished study received Oct 12, 1983 under 3125-EX-188; submitted by Mobay Chemical Corp., Kansas City, MO; CDL: 072004-B)
143142 Thyssen, J. (1980) Acute Oral Toxi city to Quails: FCR 1272: Study No. 1272/048. Unpublished Mobay study no. 82347 prepared by Bayer Institute of Toxicology. 6 p.
42005407 Toll, P. (1991) Aztec 2.1 percent Granul ar: An Acute Oral LD50 with Bobwhite Quail (Colinus virginianus): Lab Project No: M4711701: 101219. Unpublished study prepared by Mobay Corp. 33 p.
42005408 Toll, P. (1990) Aztec 2.1 (percent) Granular: An Acute Oral LD50 with House Sparrows (Passer domesticus): Lab Project Number: M4711401: 100346. Unpublished study prepared by Mobay Corp. 2 p.


### 71-2 Avia n Dietary Toxicity89 MRID Citation Reference

131497 Mobay Chemical Corp. (1983) Synopsis of Environmental Toxicology of FCR 1272 (Cyfluthrin): (Summary). (Unpublished study re- ceived Oct 12, 1983 under 3125-EX-188; CDL:072004-A)
131500 Carlisle, J.; Toll, P.; Lamb, D.; et al. (1983) Acute Dietary LC50 of Cyfluthrin Technical to Mallard Ducks: Study No. 83-175-02; 85937. (Unpublished study received Oct 12, 1983 under 3125-EX- 188; submitted by Mobay Chemical Corp., Kansas City, MO; CDL: 072004-D)
131501 Carlisle, J.; Carsel, M.; Lamb, D.; et al . (1983) Acute Dietary LC50 of Cyfluthrin Technical to Bobwhite Quail: Study No. 83- 175-05; 85943. (Unpublished study received Oct 12, 1983 under 3125-EX-188; submitted by Mobay Chemical Corp., Kansas City, MO; CDL:072004-E) 

### 71-4 Avian Reproduction

MRID Citation Reference

145330 Carlisle, J. (1984) Effect of Cyfluthrin (Baythroid Technical) on Bobwhite Quail Reproduction: Study Number 83-675-08. Unpub- lished study prepared by Mobay Chemical Corp. 94 p.
145331 Carlisle, J. (1984) Effect of Cyfluthr in (Technical Baythroid) on Mallard Duck Reproduction: Study Number 83-675-06. Unpublished study prepared by Mobay Chemical Corp. 85 p.
152829 Carlisle, J. (1985) Effects of Cyfluthrin (Baythroid Technical) on Bobwhite Quail Eggshells: Study No. 85-675-04: Mobay Report No. 90275. Unpublished study prepared by Mobay Chemical Corp. 52 p.
158782 Beavers, J. (1986) Bayt hroid Technical: A One-generation Reproduc- tion Study with the Mallard (Anas platyrhynchos): Final Report: Project No.: 149-117. Unpublished Mobay Report No. 91888 pre- pa red by Wildlife International Ltd. 118 p. 

### 71-5 Simulated or Actual Field Testing

MRID Citation Reference

42005415 Fischer, D. (1991) Simulated Field Study of Acute Hazard to House Sparrows and Juvenile Northern Bobwhite Posed by Applications of Aztec 2. 1% Granular Insecticide to Cornfields: Lab Project Num- ber: M4752302: 101313. Unpublished study prepared by Mobay Corp. 78 p.
42752601 Idema, P.; Kolaszar, T.; Perritt, J.; et al. (1993) Aztec 2.1% Granular Insecticide: An Evaluation of its Effe cts Upon Avian Species in and around Corn Fields in Central Iowa: Lab Project Number: M4752303: 105013: 149-170. Unpublished study prepared by Wildlife International Ltd. 534 p. Mixture Phostebuprim/Cyfluthrin 

### 72-1 Acute Toxicity to Freshwater Fish90 MRID Citation Reference

131497 Mobay Chemical Corp. (1983) Synopsis of Environmental Toxicology of FCR 1272 (Cyfluthrin): (Summary). (Unpublished study re- ceived Oct 12, 1983 under 3125-EX-188; CDL:072004-A)
131502 Carlisle, J.; Carsel, M.; Lamb, D. (1983) Acute Toxicity of Cyflu- thrin Technical to Rainbow Trout: Study No. 83-066-02; 85701. (Unpublished study received Oct 12, 1983 under 3125-EX-188; submitted by Mobay Chemical Corp., Kansas City, MO; CDL: 072004-F)
131503 Carlisle, J.; Roney, D.; Lamb, D. (1983) Acute Toxicity of Cyflu- thrin Technical to Bluegill Sunfish: Study No. 83-066-0 5; 85809. (Unpublished study received Oct 12, 1983 under 3125-EX-188; submitted by Mobay Chemical Corp., Kansas City, MO; CDL: 072004-G)

145332 ACC 72004 Carlisle, J. (1984) Acute Toxicity of Cy fluthrin to Rainbow Trout: Study No. 84- 066-05. Unpublished study prepared by Mobay Chem- ical Corp. 10 p.
158554 Carlisle, J. (1984) Acute Toxicity of Fluorphenoxybenzaldehyde to Rainbow Trout: 86696: Study No. 84-066-07. Unpublished study prepared by Mobay Chemical Corp. 11 p.
158557 Carlisle, J. (1984) Acute Toxicity of Dichlorvinylcarboxylic Acid to Rainbow Trout: 87452: Study No. 84-066-08. Unpublished study prepared by Mobay Chemical Corp. 11 p.
41558001 Bowman, J. (1989) Acute Flow-through Toxicity of Tempo 2 EC to Blue gill (Lepomis macrochirus): Lab Project Number: 38341: 99787. Un published study prepared by Analytical Bio-Chemistry Labora- tories, Inc. 30 p.
42005425 Bowman, J.; Leak, T. (1991) Acute Fl ow-through Toxicity of (Carbon 14) Aztec to Bluegill (Lepomis macrochirus): Lab Project Num- ber: 38624: 101217. Unpublished study prepared by Analytical Bio-Chemistry Labs, Inc. 39 p.

45375001 Beta -Cyfluthrin PC Code 118831 Bowers, L. (1994) Acute Toxicity of (carbon 14)- FCR 4545 to the Rainbow Trout (Oncorhynchus mykiss) Under Fl ow-Through Conditions: Lab Project Number: F5812202: 106656. Unpublished study prepared by Miles Inc. 34 p.

45375002 Beta- Cyfluthrin PC Code 118831 Surprenant, D. (1991) Acute Toxicity of FCR 4545 Technical to Rainbow Trout (Oncorhynchus mykiss) Under Flow-Through Conditions: Lab Project Number: 103231: 274.0387.6121.108: 89-6-2998. Unpublished study prepared by Springborn Labs., Inc. 58 p.

45375003 Beta -Cyfluthrin PC Code 118831 Surprenant, D. (1991) Acute Toxicity of FCR 4545 Technical to Bluegill (Lepomis macrochirus) Under Flow-Through Conditions: Lab Project Number: 103232: 274.0387.6121.105: 89-5-2985. Unpublished study prepared by Springborn Labs., Inc. 57 p.

45426703 Beta -Cyfluthrin PC Code 118831 Grau, R.; Kollbach, R.; Kohler, J. (1 988) The Acute Toxicity of FCR 4545 (Techn.) to Rainbow Trout (Salmo gairdneri) in a Flow-Through Test: Lab Project Number: E 2810061-8: 99197. Unpublished study prepared by Bayer AG. 19 p.
41558002 Bowman, J. (1989) Acute Flow-thro ugh Toxicity of ?carbon 14|-Tempo 2 EC To Rainbow Trout (Oncorhynchus my kiss): Lab Project Number: 38342: 99843. Unpublished study prepared by Anal ytical Bio- Chemistry Laboratories.91 31 p.

45426707 Beta -Cyfluthrin Gagliano, G. (1994) Acute Toxicity of (Carbon 14)-Cyflut hrin to the Bluegill (Lepomis macrochirus) Under Flow-Through Conditions: Lab Project Number: BD810301: 106774. Unpublished study prep ared by Miles Incorporated. 34 p.

45426706 Beta -Cyfluthrin Bowers, L. (1994) Acute Toxicity of (Carbon 14)-FCR 4545 to the Bluegill (Lepomis macrochirus) Under Flow-Through Conditions: Lab Project Number: F5810302: 106655. Unpublished study prep ared by Miles Incorporated. 34 p.

45426705 Beta -Cyfluthrin Bowers, L. (1994) Acute Toxicity of (Carbon 14)-Cyfluthrin to the Rainbow Trout (Oncorhynchus mykiss) Under Fl ow-Through Conditions: Lab Project Number: BD812202: 106652. Unpublished study prepared by Miles Incorporated. 35 p

45426708 Beta -Cyfluthrin Gagliano, G.; Bowers, L. (1994) Acute Toxi city of (Carbon 14)-Cyfluthrin to the Rainbow trout (Oncorhynchus mykiss) Under Flow-Through Conditions: Lab Project Number: BD812201: 106778. Unpublished study prepared by Miles Incorporated. 33 p.


### 72-2 Acute Toxici ty to Freshwater Invertebrates

MRID Citation Reference

131497 Mobay Chemical Corp. (1983) Synopsis of Environmental Toxicology of FCR 1272 (Cyfluthrin): (Summary). (Unpublished study re- ceived Oct 12, 1983 under 3125-EX-188; CDL:072004-A)
131504 Carlisle, J.; Carsel, M.; Lamb, D. (1983) Acute Toxicity of Techni- cal Cyfluthrin (Baythroid) to Daphnia magna: Study No. 83-067- 05; 85944. (Unpublished study received Oct 12, 1983 under 3125-EX-188; submitted by Mobay Chemical Corp., Kansas City, MO; CDL:072004-H)
158555 Forbis, A.; Burgess, D. (1984) Acute Toxicity of FPB ALD to Daphnia magna: Report 31761. Unpublished study prepared by Analytical Bio-Chemistry Labs, Inc. 35 p.
158556 Forbis, A.; Burgess, D. (1984) Acute Toxicity of DCVA to Daphnia magna: Report 31762. Unpublished study prepared by Analytical Bio-Chemistry Labs, Inc. 35 p.
41494001 Suprenant, D. (1990) Acute Toxicity of (Carbon 14)-Baythroid to Crayfish (Procambus clarkii) under Flow-through Conditions: Lab Project I.D. 87-7- 2434: Mobay Report No. 100108. Unpublished study prepared by Mobay Corp., Agricultural Chemicals Div. 58 p.

41558003 Burgess, D. (1989) Acute Flow-t hrough Toxicity of ?carbon 14|-Tempo (Cyfluthrin) to Daphnia magna: Lab Project Number: 37593: 99848. Unpublished study prepared by Analytic al Bio-Chemistry Labora- tories, Inc. 30 p.
42005429 Blakemore, G.; Hicks, S.; Burgess, D. (1991) Acute Toxicity of ?carbon 14| Aztec to Daphnia magna under Flow-through Conditions :Lab Project Number: 38625: 101218. Unpublished study prep ared by Analytical Bio-Chemistry Labs, Inc. 34 p.92 42705801 Burgess, D. (1990) Acute Flow-through Toxicity of (carbon 14)-Cyfluthrin to Daphnia magna: Lab Project Number: 37684: 100321. Unpublished study prepared by ABC Labs, Inc. 29 p.

45426701 Beta -Cyfluthrin 118831 Forbis, A. (1988) Acute Toxicity of FCR 4545 -1 Technical to Daphnia Magna under Flow-Through Conditions: Lab Project Number: 34561: 98515. Unpublished study prepared by ABC Laboratories, Inc. 30 p.

45426702 Beta -Cyfluthrin Heimbach, F. (1988) Acute Toxicity of FCR 4545 (Techn.) to Water Fleas: Lab Project Number: 98561. Unpublished study prepared by Bayer AG. 13 p.

45375003 Beta -cyfluthrin PC Code 118831 Surprenant, D. (1991) Acute Toxicity of FCR 4545 Technical to Bluegill (Lepomis macrochirus) Under Flow-Through Conditions: Lab Project Number: 103232: 274.0387.6121.105: 89-5-2985. Unpublished study prepared by Springborn Labs., Inc. 57 p.

42605801 Wrong MRID May be same study as 41558003


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

MRID Citation Reference

146118 Barrows, B. (1984) Shell Deposition in Eastern Oyster (Crassostrea virginica) Exposed to Cyfluthrin Technical in a Static Test System: Project No. 84E060CV. Unpublished study prepared by Biospherics, Inc. 10 p.
146485 Barrows, B. (1984) The Static Acute To xicity of Cyfluthrin Technical to the Sheepshead Minnow, Cyprinodon vari eqatus: Project No. 84E-060SHM: Report No. 88914. Unpublished study pr epared by Biospherics Incorporated. 14 p.
149598 Ward, G. (1985) Toxicity Test Repor t: Acute Toxicity of Cyfluthrin to the Saltwater Mysid, Mysidopsis bahia: ESE No. 85-317-0200- 2130: Mobay Report No. 90274. Unpublished study pr epared by Environmental Science and Engineering, Inc. 19 p.
158783 Carr, R. (1986) The Oyster Shell Depo sition Test To Assess the Acute Effects of Baythroid on the Eastern Oyster, (C rassostrea virginica): Final Report: Project No. N 07780100. Unpublished Mobay Report No. 91889 prepared by Battelle New England Marine Research Laboratory. 95 p.
40069501 Surprenant, D. (1987) Acute Toxicity of Baythroid to Mysid Shrimp (Mysidopsis bahia) under Flow-through Conditions : Bionomics Report #BW-87-1-2277: Bionomics Study #274.1286.6115.515. Un- published Mobay report 94220 prepared by Springborn Bionomics, Inc. 218 p.
44815301 Cunningham, F. (1996) MAT 7484 : Acute Effect on New Shell Growth of the Eastern Oyster (Crassostrea virginica): Lab Project Number: J9604005D: 107660: 107370. Unpublished study pr epared by Toxikon Environmental Sciences. 64 p.
44815302 Cunningham, F. (1996) MAT 7484 : Acute Toxicity to Mysid Shrimp (Mysidopsis bahia) Under Flow-Through Conditions: Lab Project Number: J9604005C: 107524: 107527. Unpublis hed study prepared by Toxikon Environmental Sciences. 74 p.
44815303 Cunningham, F. (1996) MAT 7484 : Acute Toxicity to the Sheepshead Minnow93 (Cyprinodon variegatus) Under Flow-Through Conditions: Lab Project Number: J9608008: 107666: 107527. Unpublished study prepared by Toxikon Environmental Sciences. 73 p.
46591506 Putt, A. (2005) Cyfluthrin - Toxicity to Estuarine Amphipods (Leptocheirus plumulosus) During a 28-Day Sediment Exposure. Project Number: 13656/6116. Unpublished study prepared by Springborn Smithers Laboratories. 85 p.

45426704 Beta- cyfluthrin = PC Code 118831 Machado, M. (1994) Acute Toxicity of FCR 4545 to Mysid Shrimp (Mysidopsis bahia) Under Flow-Through Conditions: Lab Project Number: 13507.1293.6105.515: 106588. Unpublished study prepared by Springborn Laboratories Incorporated. 72 p.

45426709 Beta -cyfluthrin = PC Code 118831 Machado, M. (1994) Acute Toxicity of FCR 4545 to the Mysid Shrimp (Mysidopsis bahia) Under Flow-Through Conditions: Lab Project Number: 106797: 13507.0894.6108.515. Unpublished study prepared by Springborn Laboratories Incorporated. 72 p.


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

MRID Citation Reference

145333 Carlisle, J. (1984) Toxicity of Cyfluthrin (Baythroid) to Rainbow Trout Early Life Stages: Study No. 83-666-05. Unpublished study prepared by Mobay Chemical Corp. 13 p.
151442 Forbis, A.; Burgess, D.; Franklin, L.; et al. (1984) Chronic Toxi- city of [Carbon 14]-Cyfluthrin to Daphnia magna under Flow- through Test Conditions: Final Report #31763. Unpublished Mobay Report No. 88690 and Toxicology Report No. 557 prepared by Ana- lytical Bio-Chemistry Laboratories, Inc. 255 p.
155898 Carlisle, J. (1985) Toxicity of Cyfluthrin (Baythroid) Technical to Early Life Stages of Rainbow Trout: Study No. 85- 666-01. Unpub- lished study prepared by Mobay Chemical Corp. 20 p.
158781 Ward, G. (1986) Effects of Cyfluthrin on Survival, Growth, and Development of Sheepshead Minnow (Cyp rinodon variegatus): ESE No. 85-317-0830-2130. Unpublished Mobay Report No. 91887 prepared by Environmental Science and Engineering, Inc. 29 p.
158784 Carr, R. (1986) Chronic Toxicity of Baythroid to the Sheepshead Minnow, Cyprinodon variegatus: Final Report: Project No. N 0778-0100. Unpublished Mobay Report No. 91890 prepared by Battelle New England Marine Research Lab. 115 p.
158785 Hoberg, J.; Breteler, R. (1986) Chronic Toxicity of Baythroid to Opossum Shrimp (Mysidopsis bahia): Report # BW-86-3-1964 ; Study #274-0286-6106- 530. Unpublished Mobay Report No. 91891 prepared by Springborn Bionomics, Inc. 59 p.
164499 Brussell, G. (1986) Letter sent to G. LaRocca dated Oct 29, 1986: Baythroid 2 on cotton: [Including Page 9 of Mobay report no. 91890 and supporting raw data for Mobay report no. 91890, 91887 and 91891]. Prepared by Mobay Chemical Corp. 2307 p.94 40047301 Breteler, R. (1987) Chronic Toxicity of Baythroid to Opossum Shrimp (Mysidopsis bahia): Report #BW-86-3-1964 : Study #274-0286-6106- 530. Unpublished Mobay report #91891 prepared by Springborn Bionomics, Inc. 148 p.
41450401 Rhodes, J.; McAllister, W.; Leak, T.; et al. (1990) Full Life-cycle Toxicity of ?Carbon 14|-Cyfluthrin (Baythroid) to the Fathead Minnow (Pimephales promelas) under Flow-through Conditions: Final Report #33821: Mobay Report No. 100097. Unpublished study prepared by Analytical Bio-Chemistry Laboratories, Inc. 905 p.
40359001 Breteler, R. (1986) Chronic Toxicity of Baythroid to Opussum Shrimp (Mysidopsis bahia ): Supplemental Submission to Mrid No. 158785 : Addendum to Mobay Report No. 91891: Study No.: 274-0286-6106- 530. Unpublished study prepared by Springborn Bionomics, Inc. 12 p.
40359002 Carlisle, J. (1985) Toxicity of Cyfluthrin (Baythroid) Technical to Early Life Stages of Rainbow Trout: Supplemental Submission to Mrid No. 155898: Addendum to Mobay Report No. 90801: Study No.: 85-66601. Unpublished study prepared by Mobay Corp. 22 p. 

### 72-5 Fish Full Lifecycle Study

41450401 Rhodes, J.; McAllister, W.; Leak, T.; et al. (1990) Full Life-cycle Toxicity of ?Carbon 14|-Cyfluthrin (Baythroid) to the Fathead Minnow (Pimephales promelas) under Flow-through Conditions: Final Report #33821: Mobay Report No. 100097. Unpublished study prepared by Analytical Bio-Chemistry Laboratories, Inc. 905 p. 

### 72-7 Simulated or Actual Field Testing

MRID Citation Reference

41511301 Kennedy, J.; Johnson, P.; Montandon, R. (1990) Assessment of the Potential Ecological/Biological Effects of BAYTHROID (Cyfluthrin) utilizing Artificial Pond Systems: Lab Project Number: 100147. Unpublished study prepared by University of North Texas. 1600 p.
42005434 Graney, R.; Giddings, J. (1991) Aztec: Aquatic Microcosm Test for Environmental Fate and Ecological Effects: Lab Project Number: M4882401: 101293. Unpublished study prepared by ABC Labs, Inc. in coop. with Mobay Corp. and Springborn Labs. 321 p. Mixture 2 ais
42734801 Graney, R.; Gagliano, G. (1993) Response to EPA Review of: Assessment of the Potential Ecological / Biological Effects of BAYTHROID (Cyfluthrin) Utilizing Artificial Pond Systems: S upplemental Report: Lab Project Number: 100147-1. Unpublished study prepared by Un iversity of North Texas. 632 p. 

### 123-2 Aquatic plant growth

MRID Citation Reference

41450402 or 158558 Heimbach, F. (1984) Growth Inhibition of Green Algae (Scenedesmus subspicatus) caused by FCR 1272 (Technical): Report No. 99836. Unpublished study prepared by Bayer AG, Institute for Environmental Biology.95 14 p.
43984901 Dobbs, M. (1996) Toxicity of Cyfl uthrin to the Green Alga, Selenastrum capricornutum: Lab Project Number: 1 07333: BD883501. Unpublished study prepared by Bayer Corp. 36 p.
158558 Heimbach, F. (1984) Growth Inhibition of Green Algae (Scenedesmus subspicatus) by FCR 1272 (Technica l): Report HBF/A102: Study No. A1 04/84. Unpublished study prepared by Bayer AG. 15 p. 

### 141-1 Honey bee acute contact

MRID Citation Reference

153638 Atkins, E. (1984) Letter sent to C. Engle dated Nov 21, 1984: Honey bee adult worker (BATDT) laboratory LD/50 toxicity study with cyfluthrin, Bathroid] (sic). Prepared by Univ. of California, Rivers ide, Dept. of Entomology. 32 p.
47775501 Chauzat, M.; Carpentier, P.; Martel, A. ; et al. (2009) Influence of Pesticide Residues on Honey Bee (Hymenoptera: Apidae) Colony Health in France. Environmental Entomology 38(3): 514-523.
47796306 Marletto, F.; Patetta, A.; Manino, A. (2003) Laboratory Assessment of Pesticide Toxicity to Bumblebees. Bulletin of Insectology 56(1): 155-158.
162586 Schmidt, H. (1985) [Bee Toxicity of Baythroid Sprayed on Alfalfa]: Report No. VAZ 16/85. Unpublished study prepared by Bayer AG. 18 p. 

### 141-2 Honey bee residue on foliage

MRID Citation Reference

158786 Bayer AG (1986) Letter sent to Mobay Chemical Corp. dated March 10, 1986: Honey bee residue testing/Baythroid: [Foliar residues in Alfalfa]: Mobay Report No. 91915. 39 p.
47800530 Chauzat, M.; Carpentier, P.; Martel, A. ; et al. (2009) Influence of Pesticide Residues on Honey Bee (Hymenoptera: Apidae) Colony Health in France. Environ. Entomol. 38(3):514-523.
47796308 Gels, J.; Held, D.; Potter, D. (2002) Hazards of Insecticides of the Bumble Bees Bombus impatiens (Hymenoptera: Apidae) Foraging on Flowering White Clover in Turf. J. Econ. Entomol. 95(4): 722-728.


### 850.1790 Chironom id Sediment Toxicity Test

MRID Citation Reference

46871501 Giddings, J. (2006) Overview of Sedi ment Toxicity Studies with Synthetic Pyrethroids. Project Number: 06723, 06273. Unpublished study prepared by Compliance Services International. 62 p.
46591507 Putt, A. (2005) Cyfluthrin - Toxicity to Midge (Chironomus tentans) During a 10-Day Sediment Exposure. Project Number: 13656/6115. Unpublished study96 prepared by Springborn Smit hers Laboratories. 89 p.



### Non Guideline Selections
157786 Machemer, L.; Eben, A.; Thyssen, J. (1983) Toxicity of Pyrethroids in Warmblooded Animals with Special Reference to Cyfluthrin. Unpublished paper presented at the International Conference on Environmental Hazards of Agrochemicals in Developing Countries; Vol. 1; Nov 8-12, 1983, Alexandria, Egypt. 20 p.

42005416 Aztec = 129086 + 128831 mixture Fischer, D. ; Toll, P. (1991) Measurement of Whole Blood and Brain Cholinesterase Activity in House Sparrows Given a Sub-lethal Dose of Aztec 2.1% Granular Insecticide: Lab Project Number: M4761401: 101312. Unpublished study prepared by Mobay Corp. 21 p.

42005418 Fischer, D.; Best, L. (1991) Oral Expos ure of Birds to Silica Gran- ules Applied at-Planting to Cornfields: Lab Project Number: GE761402: 101315. Unpublished study prepared by Mobay Corp. 32 p.
42005419 Best, L.; Gionfriddo, J. (1990) Literature Review of Grit Use by Birds: Lab Project Number: 99846. Unpublished study prep ared by Iowa State Univ., Dept. of Animal Ecology and Agrobirds. 69 p.
42005420 Best, L.; Gionfriddo, J. (1990) Characterization of Natural Grit Use in House Sparrows: Lab Project Number: 99847. Unpublished study prepared by Iowa State Univ., Dept. of Animal Ecology and Agrobirds. 29 p.
42005421 Best, L.; Gionfriddo, J. (1990) Charac terization of Grit Use by 22 Species of Birds Using Cornfields During the Breeding Season: Lab Project Number: 100129. Unpublished study prepared by Iowa State University, Dept. of Animal Ecology and Mobay Corp. 31 p.
42005422 Best, L.; Gionfriddo. J. (1991) Integrity of Five Granular Insecti- cide Carriers in the Gizzards and Intestines of House Sparrows: Lab Project Number: 1000130. Unpublished study prepared by Iowa State Univ., Dept. of Ecology and Agrobirds. 29 p.
42385001 Morris, R. (1991) Pyrethroid Inse cticide Effects on Bluegill Sunfish (Lepomis Macrochirus) and the Impacts of Bluegill Predation on Invertebrates in Microcosms: Lab Project Number: 101953. Unpublished study prepared by Mobay Corp. 111 p.
42725601 Johnson, P. (1992) Impacts of the Pyrethroid Insecticide Cyfluthrin on Aquatic Invertebrate Populations in Outdoor Ex perimental Tanks: Lab Project Number: 105036. Unpublished study prepared by Un iversity of North Texas. 5 p.
45245501 Soderlund, D.; Clark, J.; Mullin, L. et al. (2000) Pyrethroid Insecticides: Is there a Common Mechanism of Mammalian Toxicity?: Lab Project Number: PWG FQPA 2000-01. Unpublished study prepared by Pyrethroid Working Group. 144 p.
47506603 Hall, L.; Killen, W.; Anderson, R.; et. al. (2008) An Assessment of Benthic Communities with Concurrent Physical H abitat, Pyrethroid, and Metals Analysis in an Urban and Residential Stream in California in 2006 and 2007-Pyrethroid: Assessment. Project Number: T001523/08. Unpublished study prepared by Wye Research and Education Center and No rthern Illinois University. 229 p.97 Appendix 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: 835.4100 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.

The Agency has aerobic soil metabolism studies performed in two so ils, with flurophenyl labeled cyfluthrin; no data are available with cyclopropyl-l abeled cyfluthrin. A study performed in two soils should be submitted for cyfluthrin (at least one of which should be conducted with cyclopropyl-labeled cyflut hrin, for the identification of possible cyclopropyl labeled metabolites, such as DCVA). In addition, a study should be performed in four soils for beta -cyfluthrin. The data require ment is being required for beta -cyfluthrin too as pe r current draft guidance provided in the EFED Interim Policy for Stereoisomeric Pesticides, that indicates that “...an aerobic soil metabolism study (GLN 162-1/835.3300) is required as part of the mi nimal data set for enantiomeric enriched mixtures.” (Current guideline 835.4100) Furthe rmore, there is eviden ce in the literature that the degradation of cyfluthrin and beta -cyfluthrin may be enantioselective (Qin et al. 2006, Li et al. 2008). Aerobic soil metabolism studies with one soil type are generally sufficient for the evaluation of transformation pathways. Rates of transformation should be determined in at least th ree additional soils (from Fate , Transport and Transformation Test Guidelines – OCSPP Guideline 835.4100 & 835.4200).

The available supplemental anaerobic soil metabolism study, conducted on cyfluthrin, was performed with only one soil, for a period of only one month of anaerobic incubation, and sampling was insufficient to de termine a suitable half-life. A new study is required. Anaerobic studies with one soil type are generally sufficient for the evaluation of transformation pathways, but fo r cyfluthrin, cyclopropy l and phenyl-labeled studies are needed. Rates of transformation should be dete rmined in at least three additional soils (from Fate, Transport and Transformation Test Guidelines – OCSPP Guideline 835.4100 & 835.4200). Practical Utility of the Data How will the data be used? Cyfluthrin and beta -cyfluthrin are synthetic pyrethroi ds with high toxicity towards aquatic organisms, including those living in th e benthos. Knowledge of their persistence in terrestrial and aquatic environments is impor tant. The results of this study will be used98 in the environmental fate assessment, and late r 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 to determine exposure concentrations , for ecological risk estimation, and to determine surface drinking water concentrations, for 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. calculate the upperbound value derived fr om only two soils, for the aerobic soil metabolism input value). These conservative assumptions could lead to higher predicted concentrations (EECs or EDWCs), according to the models, and consequently, higher risk quotients or drinking water exposures. 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 cyfluthrin and beta -cyfluthrin that may be unnecessary.99 Guideline 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.

Two aerobic aquatic metabolism studies (soil/ se diment systems) are available that were conducted with cyclopropyl-labeled beta -cyfluthrin. The studies available that were conducted with fluorophenyl-labeled beta -cyfluthrin were considered of low quality because major deficiencies were detecte d. A study should be conducted utilizing fluorophenyl-labeled beta -cyfluthrin on one sediment sy stem of marine origin. According to the OCSPP Fate, Transport a nd Transformation Test Guidelines (835.4300 & 835.4400)...“At least two sediments and their a ssociated waters are used for both the aerobic and the anaerobic studies respectiv ely...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 marine environm ents. Sediments should be representative of intended use sites.” Since both cyfluthrin and beta -cyfluthrin have th e potential for use near estuarine/ marine areas, the required sediment system should be from estuarine/ marine environment.

There is no anaerobic aquatic metabolism st udy available for review. It should be conducted on beta -cyfluthrin. Three sediment system s are required, one of which should be of marine origin (see above). Practical Utility of the Data How will the data be used? Cyfluthrin and beta -cyfluthrin are synthetic pyrethroi ds with high toxicity towards aquatic organisms, including those living in th e benthos. Knowledge of their persistence 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 ri sk characterization.

In addition, the data will be used to derive th e rate of reaction input parameter 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 the upperboud value derived from only two supplemental values for the aerobic aquatic metabolism or two times the aerobic aquatic metabolism half-life input for the anaerobic aquatic metabolism). These conser vative assumptions could lead to higher predicted concentrations (EEC s), according to the models, an d consequently, higher risk100 quotients. Also, there would be a higher degree of uncertaintyin the environmental fate assessment. At this time, the anaerobi c aquatic metabolism of cyfluthrin and beta

cyfluthrin is uncertain. Knowle dge of these dissipation pathways in detail is essential to perform a better and accurate environmenta l 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 cyfluthrin and beta -cyfluthrin that may be unnecessary.101 Guideline Number: 835.1230 Study Title: Mobility – Adsorption/ Desorption Rationale for Requiring the Data According to 40 CFR Part 158, Subpart N (Environmental Fate) §158.1300 (Environmental fate data requirements table), this data is required for all terrestrial use patterns.

The available study was performed at a single concentrati on and no Freundlich correlations or isotherms are available. According to OCSPP Fate, Transport and Transformation Test Guideline (835.1230), the pu rpose of the main part of the study in Batch Equilibrium studies is the “Determina tion of Freundlich adsorption isotherms to determine the influence of c oncentration on the extent of adsorption on soils.” The available study indicated that cyfluthrin is re latively immobile in the various soils tested (K OC ≥ 73,500). The mobility of this chemical may be greatly under or overestimated and is uncertain. A new study is required. Practical Utility of the Data How will the data be used? Cyfluthrin and beta -cyfluthrin are synthetic pyrethroi ds with high toxicity towards aquatic organisms, including those living in th e benthos. Knowledge of their mobility in soil environments and its organic carbon normali zed Freundlich adsorption coefficient 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 mobility input paramete r to be used in the aquatic models GENEEC2, PRZM/ EXAMS, FIRST and SCI-GROW. The results from these models are used for 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 uncertain assumptions ( e.g. use the adsorption constants derived at the hi ghest concentration for the mobility input parameter in the aquatic models ). These uncertain assumptions could lead to higher or lower predicted concentrations (EECs), acco rding to the models, and consequently, higher or lower risk quotients. The K OC input parameter has a major effect in the determination of the EECs for benthic organism s. Also, there would be a higher degree of uncertainty in the environmental fate asse ssment. Knowledge of the mobility of this chemical in detail is essentia l to perform a better and accurate environmental fate 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 these chemicals that may be unnecessary.102 Guideline Number: Non-guideline Study Title: Wood Leachability Rationale for Requiring the Data A study is required. It should be conducted according to the Amer ican Wood Preservers Association Standard Method of Determini ng the Leachability of Wood Preservatives (E11-06). It is strongly suggested that the registrant provide a protocol to be evaluated by the Agency prior to performing the study. Practical Utility of the Data How will the data be used? Cyfluthrin and beta -cyfluthrin are synthetic pyrethroi ds with high toxicity towards aquatic organisms, including those living in the benthos. They are used for wood protection treatment to bu ildings/products indoor and outdoor and wood protection treatment to forest products (unseasoned). Th e results of this study will be used in the ecological risk characterization, and in particular, for aquatic assessments. At the present time, the EFED believes that cyfluthrin and beta -cyfluthrin bind strongly to the wood material, but there are uncertainties as to th e degree to which this occurs. Knowledge of the leachability from treated wood for these chemicals is important.

In addition, the data will be used to derive th e application rate to be used in the aquatic models GENEEC2 and PRZM/ EXAMS. The results from these models are used for exposure assessment and ecological risk estimation.

How could the data impact the Agency’s future decision-making? Without these data, the Agency would have to make certain uncertain assumptions ( e.g. assume that 100% of the cyfluthrin and/ or the beta -cyfluthrin leaches instantaneously from the wood, to estimate the applicati on rate in GENEEC and PRZM/ EXAMS). These uncertain assumptions could lead to higher predicted con centrations (EECs), according to the models, and consequently, higher risk quotients. The application rate input parameter has a major effect in the determination of the aquatic EECs. Also, there would be a higher degree of uncertainty in the overall transport assessment for ecological effects. Knowledge of the leachability from treated wood of this ch emical in detail is essential to perform a bette r and accurate environmental fate/ transport 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 this chemical that may be unnecessary.103 Guideline 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 two methods and one independent laboratory validation (MRID 41511301, 47053001 and 47053002), that could quantify cyfluthrin in water and sediment. The Agency will verify the suitabi lity of these methods and the appropriateness of their levels of qua ntization. At this time, no methods have been identified for the analysis of beta -cyfluthrin. In addition to the method for soil, at this time, methods are required for water and sediment. The results of previous assessments indicate that there is risk fo r freshwater and estuarine/ marine fish, invertebrates and benthic organisms. Th erefore, 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 laborato ry studies that exceed 10% of the applied. Acceptable ECMs for the residues of concern (parent and its transformation products, DCVA, FPBacid and FPB-ald) should have levels of quan tization that are adequate to address risk concerns or that are at levels below the t oxicological endpoints for the relevant aquatic organisms. 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 th e case of drinking wate rs), 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 cyfluthrin, beta -cyfluthrin and transformation products (DCVA, FPB-acid and FPB-ald) in soil, water a nd sediment is restricted. The lack of these data will limit the flexibility the Agen cy and registrants have in coming into compliance with the Endangered Species Act, and could result in us e restrictions for cyfluthrin and beta -cyfluthrin which may otherwis e be avoided, or which are unnecessarily severe.104 Guideline Number: None Study Title: POTW Effluent Monitoring and POTW Treatability Study Rationale for Requiring the Data POTW Effluent Monitoring – Request any existing or ongoing POTW effluent monitoring data for the pyrethroids be submitted to the Agency.

POTW Treatability Study – In addition, the Agency is anticipating requiring a bench scale study of waste water treatment, to assess the percentage removed in the biosolids by the treatment, the amount that would degrad e during treatment, and the amount that would remain in the waste water. Practical Utility of the Data How will the data be used? These data would be used to inform rem oval percentages by waste water treatment, which is an input to the E xposure and Fate Assessment Screening Tool’s (E-FAST) down-the-drain module.

How could the data impact the Agency’s future decision-making? Without these data, the Agency will have to make assumptions regarding the level of removal of cyfluthrin and beta-cyfluthrin ( e.g. , results of modeling from the EPIWEB v.4.0 may be used). These assumptions are likely to be crude and conservative. 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 cyfluthrin and beta -cyfluthrin which may otherwis e be avoided, or which are unnecessarily severe.105 Guideline Number: 850.2100 Study Title: Passerine Acute Avian Oral Rationale for Requiring the Data An acute avian oral study was received fo r bobwhite quail. The Agency updated its data requirements in 40 CFR Part 158 (October 26, 20 07) to include an acute oral toxicity study for both a passerine species and either a waterfowl or an upland game species. Prior to starting toxicity tes ting, a protocol will need to be provided for review. Many passerine species utilize agricultural fields, forests, re sidential areas and surrounding areas, and, therefore, have the potential to be exposed to pes ticides used in agricultural, forest, and residential settings. It is likely that, for most pe sticide use patterns, passerines are more likely to be exposed to pesticides than upland game species and waterfowl. Passerines are smaller in size and generally 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.

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 cyfluthrin. The data will reduce uncertainties associated with the current risk assessment for passerine speci es and will improve our understanding of the potential effects of cyfluthrin.

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 accep table data for cyfluthrin, the Agency cannot determine the level of exposure that resu lt in effects to passe rine 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 coming into compliance w ith the Endangered Species Act, and could result in use restrictions fo r cyfluthrin which may otherw ise be avoided, or which are unnecessarily severe.106 Guideline Number: 850.2300 Chronic Toxicity for Avian Species Study Title: Avian Reproduction St udy (Waterfowl with cyfluthrin TGAI)

Rationale for Requiring the Data No acceptable data on reproductive toxicity to the most sensitive bird species has been submitted (mallard duck). A chronic risk assessment for birds is needed based on cyfluthrin’s use patterns and potential impact on birds. Th e avian reproduction toxicity study is justified for cyfluthrin because 1) the avian reproduction studies for both waterfowl and upland game bird species are standard data requirements for all outdoor terrestrial use patterns, 2) evidence of chronic toxicity to mammals indicates possible chronic toxicity in birds, and 3) cyfluthrin use pattern indi cates that chronic exposure is likely. Practical Utility of the Data How will the data be used? The avian reproduction studies are needed for future regulatory decisions and for an endangered species assessment in particular . The data would allow the Agency to quantify the potential for chronic risk, as measured by effects on reproduction and hatchling survival, from the us e of cyfluthrin. Results of this study would be used to calculate risks to avian repr oduction from dietary exposure to cyfluthrin at labeled use rates and to identify what, if any, label langu age is needed to mitigate identified risks.

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 cyfluthrin "may affect" birds directly (and endangered species from other taxa indirec tly), and use of cyfluthrin might need to be restricted in areas where endangered species could be expose d. The lack of these data will limit the flexibility the Agency and registrants ha ve in coming into compliance with the Endangered Species Act and could result in us e restrictions for cyfluthrin which are unnecessarily severe.107 Guideline Number: 850.1075 Study Title: Fish Acute Toxicity (saltwater, cyfluthrin TEP only) Guideline Number: 850.1025 Study Title: Oyster Acute Toxicity (saltwater, cyfluthrin TEP only) Guideline Number: 850.1035 Study Title: Mysid Acute Toxicity (saltwater, cyfluthrin TEP only)

Rationale for Requiring the Data

Cyfluthrin and beta-cyfluthrin have the potential to enter estuarine/mari ne water bodies based on current usage patterns that include coastal areas (see Fig. 3.1). Cyflut hrin technical is very highly toxic to estuarine/marine fish a nd invertebrates on an acute basis, but no information is available for cyfluthrin TEP effects on estuarine/marine species.

According to the Part 158 data requirements, testing on the typical end-use product may be required for aquatic toxicity tests when any of the following conditions exist: 1. The end-use product will be introduced directly into the a quatic environment. 2. The maximum expected environmental c oncentration or estimated environmental concentration in the aquatic environment is greater than or equal to one-half the LC 50 or EC 50 of the TGAI. 3. An ingredient in the end-us e formulation other than the activ e ingredient is expected to enhance the toxicity of the active ingredient or cause toxicity to aquatic organisms.

Previous assessments on cyfluthrin indicate that the expected e nvironmental concentrations in aquatic environments are well above acute 50% mortality levels for all species tested. For example, the maximum peak aquatic EEC was 2.67 μg ai/L based on the PRZM/EXAMS MS cotton scenario in the cyfluthrin new use 2004 as sessment for a variety of crops, including tree nuts, grapes and leafy vegetables (DP 274813, 290926, 290922, 291313, 291923, 294835 and 294488). In estuarine/marine test s conducted with cyfluthrin t echnical, the lowest 96-hour LC 50 was 4.05 μg/L for sheepshead minnow, 0.0022 μg/L for mysid shrimp and 2.69 μg/L for the eastern oyster. Therefore, cyfluthrin fulfills th e second requirement (above) for TEP studies with all tested estuarine/marine species.

Practical Utility of the Data How will the data be used? These data are needed for a registration revi ew decision and for an endangered species assessment, which will be conducted as part of th at decision. The data would allow the Agency to determine acute and chronic risk to estuarine/ marine organisms from exposure to cyfluthrin. The effects data would be used to determine the likelihood that exposure to cyfluthrin can potentially impact aquatic communities, either by direct effects or by indirect effects on other organisms by reducing their food sources.

How could the data impact the Agency’s future decision-making?108 If future endangered species risk assessments are performed without th ese data, the Agency would have to assume that cyfluthrin “may affect" endangered invertebrates directly (and endangered species from other taxa indirectly), and use of cyfluthrin might need to be restricted in areas where endangered species could be expo sed. 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 use restrictions for cyfluthrin which ar e unnecessarily severe.109 Guideline Number: 850.1010 and 850.1300 Study Title: Aquatic Invertebra te Acute and Life Cycle studies ( Beta -cyfluthrin only) Rationale for Requiring the Data

Required for beta -cyfluthrin as per the EFED Interim Po licy for Stereoisomeric Pesticides. According to the interim policy, certain studies are required for stereoisomeric pesticides to identify the possibility that the chemical may be more, equally or less toxic than the previously assessed chemical (in this case, cyfluthrin).

Practical Utility of the Data How will the data be used? The aquatic invertebrate chronic toxicity study would allow the Ag ency to analyze chronic toxic effects to one of the most sensitive species of fr eshwater and marine aqua tic invertebrates. The effects data would be used to determine the lik elihood that chronic risks can potentially impact aquatic communities, either by direct effects on i nvertebrates 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 toxi city concerns with beta -cyfluthrin.

How could the data impact the Agency’s future decision-making? If future risk assessments are performed without these data, the Agency would have to account for the potential increased sensitivity of water flea and mysid to beta-cyfluthrin, as compared to cyfluthrin, using other means which may include using an extrapolation factor based on sensitivity differences with cyfluthrin. Since th is extrapolation factor would involve uncertainty, it is likely that a conservative factor would be applied. This may impinge on the Agency’s flexibility in coming into compliance with the Endangered Species Act and could result in use restrictions for beta -cyfluthrin which are unnecessarily severe.110 Guideline Number: Non-guideline Study Title: Aquatic Invertebrate Acute Toxicity ( Hyalella ) Rationale for Requiring the Data

Available information in the Agency ECOTOX da tabase indicates that the freshwater amphipod, Hyalella azteca , is substantially more sensitive to pyrethroids than Daphnia magna , the commonly tested freshwater invert ebrate. Information on the acute toxicity of cyfluthrin to H.
azteca was not identified in this problem formulation. Therefore, in order to ensure that risk to sensitive aquatic 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 used to determine the likelihood that acute risks can pot entially impact aquatic communities, either by direct effects on inverteb rates or by indirect effects by reducing the food source for their predators (e.g., fish). By refini ng the assessment, the Agency would be able to determine whether the mitigation imposed as pa rt of the registration review process was appropriate due to toxicity c oncerns with cyfluthrin.

How could the data impact the Agency’s future decision-making? If future risk assessments are performed without these data, the Agency would have to account for the potential increased sensitivity of Hyalella to cyfluthrin using other means which may include using an extrapolation factor based on sensitivity differences with other pyrethroids. Since this extrapolation factor would involve uncertain ty, it is likely that a conservative factor would be applied. This may impinge on the Agency ’s flexibility in coming into compliance with the Endangered Species Act and could result in use restrictions for cyfluthrin which are unnecessarily severe.111 Guideline Numbers: 850.1735 & 850.1740 Study Title: Whole sediment: Fr eshwater and marine invertebrates Rationale for Requiring the Data No chronic sediment toxicity tests for fres hwater or marine inve rtebrates have been submitted to satisfy the Agency’s updated data requirements for outdoor uses in 40 CFR Part 158 (October 26, 2007). For cyfluthrin, available information indicates that benthic organisms may be exposed via run-off or spra y drift applications used in agricultural, forest, and residential settings. Specifically,

o Based on preliminary calcutions, the peak sediment porewater EECs predicted for cyfluthrin (0.048 μg ai/L) exceeds 0.1 of the most sensitive acute LC/EC 50 (0.0022 μg ai/L for mysid shrimp), which satisfies one of the criteria for requiring chronic whole sediment toxicity testing under 40 CFR Part 158.

o The expected half-life of cyfluthrin in sediment (73.5-94.8 for aerobic soil metabolism and 32.9-42 days for aerobic a quatic metabolism) is substantially greater than 40 CFR Part 158 criterion of 10 days.

o The third set of trigger criteria for requ iring chronic testing (Kd > 50, or log Kow >3 or Koc > 1000) is also met for cyfl uthrin (e.g., Kd values are 974-1793, log Kow is 6, and K OC values are 69900-180300).

o Chronic effects were also seen in all aqua tic taxa tested at levels ranging from 0.00040 – 0.63 μg a.i./L.

o There is a potential for persistent exposur e from cyfluthrin 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). Cyfluthrin ha s the potential to enter estuarine/marine water bodies based on cu rrent usuage patterns that include coastal areas. Therefore, testing is required for Leptocheirus plumulosus , an estuarine/marine sediment-dwelling 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 cyfluthrin. The data will reduce uncertainties associated with the current risk assessme nt for benthic species and will improve our understanding of the potential effects of cyfluthrin.

How could the data impact the Agency’s future decision-making? Although there was uncertainty in estimating the effect of cyfluthrin on benthic organisms in previous assessments, there was a potential risk associated with adverse effects identified for other aquatic organisms. Acceptable data for benthic organisms will reduce the uncertainty from the previous assessmen t If the data indicates that registered112 cyfluthrin usage may pose a risk of adverse effects to non-target be nthic organisms above the Agency Level of Concern, the Agency ma y 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 use restrictions for cyfluthrin which may otherwise be avoide d, or which are unnecessarily

severe.113 Guideline Numbers: 850.4100 and 850.4150 Study Title: Vegetative vigor and Seedling emergence, Tier I/ Tier II (Cyfluthrin and Beta -cyfluthrin)

Rationale for Requiring the Data

No acceptable toxicity data are currently available to assess the risk of cyfluthrin to nontarget terrestrial plants. Since cyfluthrin ha s residential outdoor uses , vegetative vigor and seedling emergence studies are re quired. Additionally, three in cidents have been reported to the Agency where cyfluthrin was identifie d as the possible – highl y probable cause of phytotoxic damage. Phytotoxicity data are need ed to evaluate the level of pesticide exposure to non-target terrestrial and aquatic plants and to as sess the impact of pesticides on endangered and threatened plants. In addi tion to the studies required for cyfluthrin, tests conducted on beta -cyfluthrin are required for the most sensitive monocotyledon and dicotyledon as per requirements of the EFED Interim Policy for Stereoisomeric Pesticides.

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 cyfluthrin and beta -cyfluthrin. The data will reduce uncertainties associated with the current risk assessment for terrestrial plants and will improve our understanding of the potential eff ects of cyfluthrin 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 cyfluthrin and beta -cyfluthrin, the Agency ca nnot determine the levels of cyfluthrin that result in effects to terrestrial plants. If the data indicates that registered usage may pose a risk of adverse effects to non- target terrestrial pl ants 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 resu lt in use restrictions for cyfluthrin which may otherwise be avoided, or which are unnecessarily severe.114 Guideline Number: 850.4400 Study Title: Aquatic Vascular Plant Growth- Lemna spp. Tiers I/II (Cyfluthrin and Beta -cyfluthrin)

Rationale for Requiring the Data

No studies for cyfluthrin have been submitted for vascular aquatic plants. The Agency has finalized its update to the data re quirements in 40 CFR Part 158, which were promulgated on October 26, 2007. In these upda ted data requirements, vascular plant testing is required for pesticid es with outdoor uses, such as cy fluthrin. In addition to the study on cyfluthrin, a study is required for beta -cyfluthrin, as per the EFED Interim Policy for Stereisomeric Pesticides. 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 cyfluthrin and beta -cyfluthrin. The data will reduce uncertainties associated with the current risk assessment for aquatic plants and will improve our understanding of the potential effects 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 cyfluthrin, the Agency cannot determine the leve ls of cyfluthrin that result in effects to vascular aquatic plants. If the data indicates that regist ered usage may pose a risk of adverse effects to non-target aquatic vasc ular plants above the Agency Level of Concern, the Agency may explore 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 cyfluthrin and beta -cyfluthrin "may affect" endangered plants and use might need to be restricted in areas where endangered species could be exposed. 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 use restrictions for cyflut hrin that may be unnecessarily severe.115 

### Appendix B. Summary of registrant-s ubmitted aquatic toxicity studies for cyfluthrin and beta -cyfluthrin

Species

(common name) Test Substance % a.i. Endpoint Duration (hours) Mean concentration

(μg a.i./L) MRID and study classification Oncorhynchus mykiss (Rainbow trout) 87% LC 50 96 0.68 00131502 Acceptable

Lepomis Macrochirus (Bluegill sunfish) 87% LC 50 96 1.50 00131503 Acceptable

Lepomis Macrochirus (Bluegill sunfish) Cyfluthrin (TEMPO

2EC) 2% LC 50 96 0.647 41558001 Supplemental

Oncorhynchus mykiss (Rainbow trout) Cyfluthrin (TEMPO

2EC) 2% LC 50 96 0.295 41558002 Acceptable

Oncorhynchus mykiss (Rainbow trout) Beta

cyfluthrin, FCR-4545 98% LC 50 96 0.111 45375001 Supplemental

Oncorhynchus mykiss (Rainbow trout) Beta

cyfluthrin, FCR-4545 99.4% LC 50 96 0.068 45375002 Supplemental

Lepomis Macrochirus (Bluegill sunfish) Beta

cyfluthrin, FCR-4545 99.4% LC 50 96 0.28 45375003 Supplemental

Oncorhynchus mykiss (Rainbow trout) Beta

cyfluthrin, FCR-4545 98.1% LC 50 96 0.085 45426703 Supplemental

Oncorhynchus mykiss (Rainbow trout) Cyfluthrin 97.6% LC 50 96 0.302 45426705 Acceptable

Lepomis Macrochirus (Bluegill sunfish) Beta

cyfluthrin, FCR-4545 98% LC 50 96 0.566 45426706 Supplemental

Lepomis Macrochirus (Bluegill sunfish) Cyfluthrin 97.6% LC 50 96 0.998 45426707 Acceptable

Oncorhynchus mykiss (Rainbow trout) Cyfluthrin 97.6% LC 50 96 0.209 45426708 Supplemental116 Species

(common name) Test Substance % a.i. Endpoint Duration (hours) Mean concentration

(μg a.i./L) MRID and study classification
Oncorhynchus mykiss
(Rainbow trout) 96% NOAEC

LOAEC 58 (days) 0.010

0.018 00155898

Supplemental

Pimephales promelas (Fathead Minnow) Cyfluthrin 99% NOAEC

LOAEC 60 (days) 0.14

0.25 41450401

Acceptable

Daphnia magna

(Water Flea) Tech LC 50 48 0.141 00131504

Acceptable

Daphnia magna

(Water Flea) Beta

cyfluthrin, FCR-4545 Tech EC 50 48 0.29 45426701

Supplemental

Daphnia magna

(Water Flea) Cyfluthrin 98.6% LC 50 48 0.16 42705801

Unreviewed

Daphnia magna

(Water Flea) Cyfluthrin (TEMPO

2EC) 2% EC 50 48 0.025 41558003

Acceptable

Daphnia magna

(Water Flea) 94.7% NOAEC

LOAEC 21 (days) 0.0074

0.0157 00151442

Acceptable

Chironomus

tentans
(Midge) Cyfluthrin 99% LC 50 10 (days) 0.44 (pore water)

290 μg a.i./kg sediment
(bulk sediment) 46591507

In review

Cyprinodon variegatus (Sheepshead

minnow) 87% LC 50 96 4.05 00146485
Acceptable117 Species

(common name) Test Substance % a.i. Endpoint Duration (hours) Mean concentration

(μg a.i./L) MRID and study classification

Cyprinodon variegatus (Sheepshead

minnow) 90.5% NOAEC

LOAEC 39 (days) 0.025

0.084 00158781

Supplemental

Cyprinodon variegatus (Sheepshead

minnow) 90.5% NOAEC

LOAEC 28 (days) 0.27

0.63 00158784

Not reviewed

Mysidopsis bahia

(Mysid shrimp) 90.5% LC 50 96 0.0064 00149598

Acceptable

Mysidopsis bahia

(Mysid shrimp) 92% LC 50 96 0.0024 40069501

Acceptable

Mysidopsis bahia

(Mysid shrimp) Beta

cyfluthrin, FCR-4545 >98% LC 50 96 0.0023 45426704

Acceptable

Mysidopsis bahia

(Mysid shrimp) Beta

cyfluthrin, FCR-4545 >98% LC 50 96 0.0022 45426709

Acceptable

Crassostrea

virginica
(Eastern oyster) 93% EC 50 96 2.69 00158783

Acceptable

Leptocheirus plumulosus
(Amphipod) 99% LC 50 (survival)

EC 50 (growth) 28 (days) 35

36 46591506

In review

Mysidopsis bahia

(Mysid shrimp) 97% NOAEC

LOAEC 28 (days) 0.00017

0.00040 00158785

Supplemental118 

### Appendix C. Open Literature Information

The following is a cursory search of th e available literature on cyfluthrin, beta -cyfluthrin and synthetic pyrethroids in general, mostly about their prevalence/ occurrence, and about their toxicity to aquatic invertebrates and sediment dw elling 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 toxicity of cyfluthrin, and other synthetic pyrethroids, in sediment e nvironments of urban and agricultural sites, particularly in California.

In a 3-year field te st studying honey bee ( Apis mellifera ) colony health, Chauzat et al. (2009) found no residues of cyfluthrin at levels of 0.7 μg/bee (MRID 47775501) (Note that the acute contact LD 50 for honeybees is 0.037 μg/bee according to registrantsubmitted studies). Although no statistical si gnificant relationships were found between colony mortality and the presence of pesticides overall, the authors state that “more work is needed to determine the role these residues play in affec ting colony health”. In another study, Dai et al. (2010) examined the sublethal eff ects of two pyrethroids, deltamethrin and bifenthrin, on bee colony health. The authors concluded th at both chemicals adversely impacted bees by reducing bee f ecundity and decreasi ng the rate of bee development into adulthood.

Ureda (2004) determined the LC 50 s for deltamethrin, lambda-c yhalothrin and cyfluthrin, using the test species Hyalella azteca . Also, sediment samples from two locations in Central Valley, California were tested. They found that there was a linear relationship between the LC 50 and the total organic carbon for cyfluthrin, but not for lambdacyhalothrin or for deltamethrin. Th ey found that for cyfluthrin, the LC 50 s ranged from 0.34 to 1.07 μ g/g OC . The LOEC for cyfluthrin were 0.17-0.77 μ g/g OC . In addition, Amweg, et al. , 2005 determined the toxicity of six pyrethroids in three Central Valley, CA sediments towards Hyalella azteca . They found that of a ll the synthetic pyrethroids tested, bifenthrin exhibited th e highest toxicity, while for cy fluthrin the average sediment 10-day median LC 50 was roughly an order of magnitude higher (or less toxic) than for bifenthrin. The actual value was 1.08 μg/g OC , which is of the same order of magnitude reported in the Ureda 2004 study.

Two major factors that affect the toxicity of the pyrethroids include the presence of a synergist, such as piperonyl butoxide (PBO) and the temperature. Amweg et al. 2006a documented the effect of PBO on the pyret hroid permethrin’s toxicity towards Hyalella

azteca in sediment samples. It was found th at PBO could increase the toxicity of permethrin in sediment up to seven-fo ld. Also, Amweg and Weston 2007, documented the effects of the presence of PBO in se diments containing the synthetic pyrethroid bifenthrin and other repres entative chemicals, which included cadmium (a metal), chlorpyrifos (an organophosphate), DDT (a n organochlorine), and flouranthene (a polycyclic aromatic hydrocarbon). The presen ce of PBO was considered as a Toxicity Identification Evaluation (TIE) tool. The 10-day Hyalella azteca LC 50 was 0.26 μg/g OC , compared to 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 around or119 less than 1 with no statistical difference in to xicity for all but chlorpyrifos. Eight field collected sediments, containing a variety of synthetic pyrethroids, or synthetic pyrethroids and chlorpyrifos (except for one se diment 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 that 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 (TIE refers to “man ipulating a sample in a manner that alters the toxicity of some toxicants but not others”), they perf ormed sediment toxicity tests at various temperatures (13, 18, 23 and 28oC). 10-day LC 50 ’s to Hyalella azteca were determined for four pyrethroids, (permethrin, bifenthri n, esfenvalerate and cyhalothrin), also for chlorpyrifos, cadmium and DDT (which were representative of other classes of chemicals). For the four pyrethroids, the toxicity a pproximately doubled when the temperature was decreased from 23 to 18o C, and approximately tripled when the temperature was further decrease d 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 tolerant of the change to high temperat ure. For DDT, there was a similar response profile with temperature, but not as pronoun ced as for the synthetic pyrethroids. For chlorpyrifos and cadmium, the responses with temperature were either nearly independent of temperature or opposite to the one for the pyrethroids (increasing toxicity with increasing temperature), respectively. Various field samples with known amounts of pyrethroids (some of which contained cyfl uthrin), also showed similar responses to those of the tested pyrethroids (as indicated above), with a few exceptions. The authors discussed the possible reperc ussions of the temperature dependence of the synthetic pyrethroids during the wi nter season, when the temperatur es of the waters and sediments are lower.

Yang et al. 2007 observed the effect of dissolv ed organic matter (DOM) on the bioavailability of the pyrethroi ds cyfluthrin and permethri n, and their toxicity towards Daphnia magna and Ceriodaphnia dubia . A total of 15 surface water samples from southern California were utilized. The di ssolved organic content (DOC) ranged from 3.3- 20.2% and the pH ranged from 6.67-7.76. Various indicators were also characterized in the waters like an indicator of the level of aromaticity, the carboxyl group capacity and the phenol group capacity. They also obtai ned bioconcentration factors (BCFs) for D.
magna . Using polydimethylsiloxane (PDMS) act ivated fiber, a measure of the freely dissolved pesticide concentration was obtai ned (the PDMS fibers were placed in scintillation vials and measur ed via LSC). Based on their low absortivity at 254 nm, it was suggested that the water samples had lo w DOM aromaticity. Th e E4/E6 (a ratio of absorbance at two specified wavelengths) of <5 suggested humic acid dominated composition and lesser fulvic acids. Finall y, the molar content of carboxylic acid and phenolic acid, normalized for DOC varied wide ly. The DOM did not affect the freely available permethrin, but for cyfluthrin, the fr eely available cyfluthrin was less than for the control samples in all instances. The K DOC were less for cyfluthrin than for permethrin by about twice, suggesting a ffinity of cyfluthrin towards the DOM.120 K DOC = (C w – C free ) / (DOC x C free ) The cyfluthrin D. magna body residues were lower than in the control in 14 of the 15 samples (for 9 samples, the difference was significant). There was a significant correlation between the cyfl uthrin body residue and C free , but not for permethrin. In 96- hour static expos ure tests with C. dubia neonates, the cyfluthrin LC 50 s were greater than the controls in every case (for 7 samples, the difference was signifi cant). These findings suggest high affinity of cyfluthrin with organic carbon and organic matter, and lower bioavailability in natural wate rs than in control waters.

In a recent study (Stout II, et al. 2009), c onducted 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 several synthetic pyrethroids like cyfluthrin. The most frequently detected pes ticide was permethrin (89% of the samples). Cyfluthrin was detected with a frequency of 17% (n = 480 samples; mean not reported for chemicals with detection frequency below 30%; maximum value = 129 ng/cm 2 ), illustrating that this chemical is commonl y applied, detected and present in homes. Cyfluthrin is among the constituents monitored by the National Water Quality Assessment (NAWQA), maintained by the U. S. Geological Survey. Two kinds of parameters (types of samples) are reporte d. One is “Cyfluthrin_ water_ filtered_ recoverable_ micrograms per liter,” with a reported percent of samples with this parameter of 9.7 (report units of μ g/L). The other is “Cyfluthrin_ solids_ recoverable_ dry weight_ micrograms per kilogram,” with a reported percent of samples with this parameter of 0.1 (report units of μ g/Kg).

Multiple articles from the literature document the presence of synthetic pyrethroids, including cyfluthrin, in both urban and agricu ltu ral sediments. Weston et al. 2005, studied the presence of synthe tic pyrethroids in Roseville, CA, selected as a typical suburban development. Sediments from creeks that drain subdivisions of single-family homes were found to be toxic to Hyalella azteca . The sediments were tested for several pesticides, including 7 pyrethroid s. Bifenthrin was present in all the sediment samples. It was considered to be the primary cause of the toxicity towards the organism, with additional contributions of th e pyrethroids cyfluthrin and cypermethrin. The maximum concentration of cyfluthrin was found to be 169 ng/g dry weight, for a tributary of Kaseberg Creek, in sampling site 11. It was de tected in 12 out of 24 sediment samples. The authors indicate that the pr esence of synthetic pyrethroids was not likely to be due to agricultural uses. In Placer County, the use of synthe tic pyrethroids for agricultural purposes was reported to amount to around 1%.

Amweg et al. 2006b also studied synthetic pyrethroids in urban areas of California and Tennessee. Bifenthrin w as found to be the majo r contributor to the t oxicity of sediments sampled in California to Hyalella azteca , due to its high reporte d concentrations and toxicity. Cypermethrin, cy fluthrin, deltamethrin and la mbda-cyhalothrin may have contributed to the toxicity in some of the si tes. The concentrations of cypermethrin and cyfluthrin were typically higher than for ot her synthetic pyrethroids (usually 2-30 ng/g), but the bifenthrin and permethrin concentratio ns were the highest. On the other hand, in Tennessee only a few samples contained synthetic pyrethroids and none of the samples121 were toxic to Hyalella azteca . The differences between the two sites were attributed to different climate, types of residential development and pesticide use practices.

Holmes et al. 2008 presented the occurrence and toxi city of the synthetic pyrethroids throughout the state of Californi a’s urban creek sedim ent sa mples. First, 90 samples were screened for toxicity to Hyalella azteca , of which around one third caused significant toxicity to the organism. 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 synt hetic pyrethroids often show higher toxicity at lower temperatures, as indicated above). Seven of eight pyrethroids were detected in the sediment samples. Fenpropathrin was not detected in any of the samples, and deltamethrin and esfenvalerate were detected infrequently; but bifenthrin was present in all the 30 samples (2.19 to 219 ng/g dry wei ght). Permethrin was the second most detected pyrethroid and cyfluthrin was de tected in 16 samples, with a highest concentration of 127 ng/g dry weight. The re sults suggested an important role of the synthetic pyrethroids in California’s urba n creeks sediment toxicity. Bifenthrin accounted for around two thirds of the toxicity on an average basis, with cyfluthrin and cypermethrin also playing an important ro le in the pyrethroid toxicity statewide.

Trimble et al. 2009 screened a previously referenced database of 24 pesticides and 94 urban sediment samples, with minimal agricu ltural or industrial contribution, collected from creeks and streams throughout central and northern California. The seven synthetic pyrethroids tested and chlor pyrifos were the pesticides most commonly occurring in toxicologically significant mi xtures. Bifenthrin, permethr in and DDT were observed in greater than 90% of the samp les. After normalizing the chemical concentrations for organic carbon “to provide be tter estimates of the biologically available chemical fractions,” all the seven pyrethroids monitore d had levels exceeding the established level of interest, LOI (defined as 0.005 toxic uni ts, 0.005 TU) for at least one sample. Cyfluthrin was detected in ar ound 70% of the samples (Fig. 1 of the report). Bifenthrin, cypermethrin and cyfluthrin exceeded 0.5 TU (100x the initially established LOI) in greater than 30% of the samples. It was st ated that... “The three pesticides with the highest average TU values were bifenthr in (2.4 TU), cypermethrin (1.2 TU), and cyfluthrin (0.5 TU).” These are just a few examples that illustra te the high use of synthetic pyrethroids in urban settings and potentia l 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 samples. Cyfluthrin was observed less frequently, at a highest concentration of 2.48 ug/kg. The high est concentrations were associated with commercial nurseries. The authors found in this case that the concentration of synthetic pyrethroids was generally lower in reside ntial or commercial areas as opposed to agricultural sites. Also, the frequency of detections of pyr ethroids was higher during the wet season ( e.g. , cyfluthrin 33% vs. 5%), but the tota l concentration was not statistically different between the wet and dry seasons.122 Weston et al. 2004 studied the presence of 26 pesticid es, including five pyrethroids, in 70 sediment samples taken from the agriculture dominated Central Valley in California. Ten-day sediment tests were conducted for Hyalella azteca and Chironomus dilutus (formerly known as Chironomus tentans ), for some of the sample s. 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 > esfenvalerat e > bifenthrin > lambda-cyhalothrin. Even though this study did not in clude cyfluthrin or beta -cyfluthrin, the presence of several synthetic pyrethroids illustrat ed the possibility of high le vels of several synthetic pyrethroids in agricultural zones.

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 pe rmethrin and bifenthrin, along a 260 meters 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 calculated for these chemicals. The ERs reached 25.7- 32.2 for bifenthrin at 145 m and beyond, and they were lower for permethrin. Also, the persistence of the test su bstances was assessed, both, in aerobic and anaerobic environments. Despite the fact that this study was not conducted with cyfluthrin or beta

cyfluthrin, this study illustrate d the possibility of enrichment through a runoff path for the synthetic pyrethroids.

Woudneh & Oros 2006 presented a multi-chemi cal analytical method that included among others cyfluthrin and pi peronyl butoxide (PBO). Analysis of the San Francisco Bay tributary sediment samples (six samples from five sites) revealed that cyfluthrin was detected in one of the sediments, at 17.6 ng/g and was less than the detection limit in the other samples. PBO was detected in all the samples at 0.010-0.215 ng/g.

Weston et al. 2009b, found that bifenthrin was the mo st frequently detected pyrethroid from runoff waters from Roseville and Elk Gr ove urban sites. Cyfl uthrin, cypermethrin and permethrin were also detected frequen tly. During the dry season, cyfluthrin was detected with a frequency of 50%, while during the wet season, it was found with a frequency of detection of 100% (maximum c oncentration 26.6 ng/L). It was noted that stormwater runoff (which occurs mostly around the winter) was responsible for more transport than irrigation runoff (which o ccurs mostly around the summer), towards surface waters. It was suggested that mitigati on of the effects of the synthetic pyrethroids would need to target both sources of runoff. It was reported that the use of bifenthrin (for retail and for professional use) was higher approximately in the months around the

summer.

Most of the studies related to the synthetic pyrethroids were conducted in California, but other studies document the presence of synthetic pyrethroids elsewhere.123 Hintzen et al. 2009 monitored for 12 insecticides a nd degradation products, including synthetic pyrethroids and fipronyl in Texas stream sediments from urban sites in 2006, as a model to evaluate their potential impact in Southern US. Bifent hrin was the pyrethroid found with the highest frequency. Cyfluthrin ’s frequency of detection was 9.8% (mean = 0.27 μ g/g OC ; maximum = 0.40 μ g/g OC ; compared to 10-day LC 50 to Hyalella azteca of 1.1
μ g/g OC ). Lamda-cyhalothrin and permethrin were also frequently detected; the detections of lamda-cyhalothrin occurred frequently at concentrations of concern, but the concentrations of permethrin were below the LC 50 for H. azteca . Bifenthrin was the greater contributor to the TUs, followed by lambda-cyhalothrin. The TUs generally correlated well with the toxici ty of the samples, although so me discrepancies between the TUs and toxicity were noted (even after norma lization for organic carbon). There were no seasonal variations of the TUs.

Ding et al. 2010 conducted monitoring for 29 pes ticides, including pyrethroids like bifenthrin, fenpropathrin and cy fluthrin, from both urban and agricultural sites in central and southern counties in the st ate of Illinois in 2008. Most of the urban samples were from constructed storm drains, while the agri cultural 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 fenpropa thrin were also frequently detected; cyfluthrin was not detected. In the agri cultural samples, bifenthrin, permethrin, cypermethrin and tefluthrin we re detected (frequency of de tection 47%), while cyfluthrin, fenpropathrin 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 agricultural sediment samples was signifi cantly more toxic than the controls. The major source of TUs were the pyrethroids (in particular, bifenthrin). It was indicated that the detections of fenpropathrin in the urba n samples was unexpected because it is a pesticide primarily used in agriculture.

LeBlanc & Perkins, 2009, documented the pres ence of synthetic py rethroids in Maine sediments. Of five synthe tic pyrethroids monitored, only bifenthrin was detected, at levels of 1.26 – 16.68 ng/g (means). The other synthetic pyrethroids monitored were lambda-cyhalothrin, permethrin, cyfluthrin and cypermethrin. Four sediments were monitored: Mill Creek Lower Intertidal, Mi ll Creek Upper Intertidal, Back Cove and Payson Park.

In an article, Weston & Lydy 2010 studied th e possible sources of pyrethroids in California’s Sacramento – San Joaquin River Delt a, including three type s of samples: (a). urban runoff, (b). municipal wastewater trea tment plants (or Publicly Owned Treatment Works, POTWs), and (c). agricultural disc harges, in a study that focused on water samples (as opposed to most of the studies abov e that are related to sediments). Samples were taken during the wet and dry seasons. Fi rst, urban runoff samples were taken from concrete sumps, from which pumps lift wate rs to adjacent rivers over levees. Second,124 POTW effluents with secondary (and in one case, tertiary) treatment were sampled just prior to discharge to surface waters. And finally, third, ag ricultural discharges were collected at pump stations, where the runoff is lifted over the levees. Samples were tested for 8 pyrethroids and chlorpyrifos (L OQ around 1 ng/L for most samples). Tests to Hyalella azteca were also performed on the water samples. Cyfluthrin was found in 55, 6 and 0% of the samples of urban runoff, PO TWs and agricultural drains, respectively. Also, 55, 0 and 0% of the samples, respectively, exceeded the EC 50 = 1.9 ng/L for H.
azteca . The maximum measured cyfluthrin c oncentration was 17.8 ng/L. Through TIE, it was found that the toxicity of most samples was increased in the presence of PBO. A similar effect was observed when the temperat ure 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 serum albumin (BSA), no effect on the to xicity of the samples towards H. azteca , was observed. The pyrethroid presence in POTWs was une xpected because the effluents had low suspended material and for the possible partitio ning with biosolids within the plants. The authors indicated that possibl e sources of pyrethroids are sewer disposal of household insecticides, lice control shampoos, pet products and pe rmethrin treated clothing.

Weston 2007 said that, “Contrary to popular perception, non-agr icultural use of pyrethroids far exceeds agricultural use, at leas t in California, one of the few areas where data are available. A similar situation is likely elsewhere where there is substantial urban development. Whereas agricultural use of pyrethroids in California is about 300,000 lb/yr, non-agricultural commercial use (mos tly applications done by professional pest control firms) is currently about 700,000 lb/y r. Retail sales to homeowners are not included in this non-agricultu ral figure, but are probably about another 100,000 lb/yr. Some of the major urban uses of pyrethroids include cypermethrin and permethrin for termite control, permethrin to maintain la ndscaping, and bifenthrin and cyfluthrin for a variety of pests around homes.”

Various studies provide additional environmental fate characterization of cyfluthrin and beta -cyfluthrin. It appears that cyfluthrin degrades slowly under normal conditions of aerobicity and organic matter, but degrades faster under anaerobic environments or in soils with higher organic matter. The moisture level does not appear to have a significant effect on the rate of degradation (Smith, et.al. , 1995). The degradation of cyfluthrin appeared to be faster in soils with higher pH’s (Shehata, et.al. , 1987), which would be expected based upon the results of the availabl e hydrolysis study. In a study performed by Fernández-Alvarez et al. 2007, the photolytic behavior of cyfluthrin and various other synthetic pyrethroids was studi ed under artificial and natura l light. The detection was performed using solid phase micro-extraction (SPME). After 20 minutes of exposure to UV light, cyfluthrin was almo st completely degraded, w ith 8 photoproducts tentatively identified. However, under natural light for 2 days, there was no decrease in the analytical signal of cyfluthrin, indicating that the half-life is much larger than 2 days. Additional studies, using SPME were sa id to be conducted in the future.

Gupta and Gajbhibe conducted two studies on the fate of beta -cyfluthrin. In a 2002 study, they determined the persistence and effect of moisture in alluvial soil from India.125 The half-lives ranged from 7.8 to 41.8 days. With an increased a pplication rate, the dissipation rate decreased when the soil was at field capacity or flooded, but the effect was the opposite (but not pronounc ed) in air-dried soil. The persistence was greater in air-dried soils and lower in floode d soils. In a soil column study, beta -cyfluthrin was considered to be “highly immobile” in alluvial soil with greater than 99% of the residues in the upper 0-5 cm depth. The soil was cl assified as a sandy loam and it was an inceptisol with a pH of 7.7. In 2005, the same researchers studied the fate of beta

cyfluthrin in water, and the effect of pH, temperature and presence of sediments (approximately 20 mL water plus 1 g of ai r-dried soil-sediment). They used a formulation containing 2.5% a.i. named Bull dock 025 SC. At application rates of 0.01 to 0.1 μ g/mL 10 the half-lives in wate r (pH not specified) were 8.4 – 10.5 days. At pHs 4.0, 7.0 and 9.2, and 0.1 μ g/mL, the half-lives of formulated beta -cyfluthrin were 125.4, 23.9 and 13.4 days, respectively in studies conducte d for a period of 30 days. At 5, 25 and 40°C, the half-lives were 15.1-16.4, 8.5-10.5 a nd 5.8-4.7 days respectively. In the presence of sediment, the dissipation of beta -cyfluthrin formulation from the water followed a biphasic pattern, with initial half- lives in the water of 0.75-0.81 days (initial 0- 5 day period), while the dissipation from th e soil-sediment was reported to be slower (initial 3.0-4.3 days and 13.5-13.9 during the 10-30 day period).

Qin et al. 2006 observed enantioselec tivity in the degradation of cyfluthrin and other selected pyrethroids. No substantive differe nce was observed in sterile soils, indicating preferential biological tran sformation. One soil (pH 6.7), and one sediment (pH 7.9) from California were used for incubation in this study. The incubations were performed with viable and sterile soils/ sediments. The incubations were performed with cis

bifenthrin, cis -permethrin and cypermethrin (however , they did not use cyfluthrin of beta -cyfluthrin in this part of the study). Also, duplicate se diments were collected from diverse areas of Orange County, CA and anal yzed. Analysis of the field samples indicated that for cyfluthrin for the diastere omeric pairs that follow, the stereoisomer fraction (SF) were as indicated. 1R- trans

- α R + 1S- trans

- α S, consistently <0.25, and 1R- trans

- α S + 1S- trans

- α R, consistently >0.25. They indicated that, “Of the cis enantiomers, the SF remained around 0.125 for some samples but clearly increased or decreased in the other samples...When enantioselective degradation was observed, the di rection of enantioselectivity also appeared to depend on the sampling location and environmental conditions.”

Li et al. 2008 demonstrated that for beta -cyfluthrin, the trans -diastereomer degraded faster in a loam Tianjin alkaline soil from North China (pH of 8.2). The half-lives for the cis -isomers were 17.16-28.41 days, and for the trans -isomers, they were 8.74-12.67 days. A similar enantioselective behavior was observed for beta -cypermethrin, but beta

cyfluthrin degradation was generally faster.

Moore et al. 2007 examined the use of constructe d wetlands in Leflore County, MS to mitigate exposure and ecological impacts in runoff from agricultural fields. The synthetic pyrethroids cyfluthrin and la mbda-cyhalothrin were used as model

10 It was noted that these concentrations exceed the solubility limit for beta -cyfluthrin of near 2 ppb.126 contaminants. Testing with Hyalella azteca was performed to determine the efficiency of the system. There was spatial and tem poral variation of the two pyrethroids’ concentrations in water, sediment and leaf li tter in all three wetland constructed cells. By 61 days, there were little or no pyrethroids in water or leaf-litter. The concentration of the pyrethroids decreased with distance fr om the application point, but there was no decrease in the H. azteca toxicity in water during th e 61-day observation period even though the pyrethroids’ concentrations decr eased significantly. The authors concluded that the pyrethroids can m ove, affecting non-target aqua tic organisms for weeks to months after entering a constructed wetland.

In 2009, Moore et al. also used cyfluthrin and la mbda-cyhalothrin in constructed wetlands (comprised of a sediment retenti on basin, and two treatment cells) in a study lasting 55 days. A high percentage of the measured cyfluthrin was associated with vegetation while for lambda-cyha lothrin, it was associated w ith the sediment. It was determined that wetlands lengths of 210-217 m were required to mitigate inflow of both chemicals from a 14 ha contributing field.127 

### Appendix D. Test Run for Cyfluthrin Representing the Cotton Use

Modeling Results

Table 1. Estimated Environmental Co ncentrations (EECs) for Cyfluthrin MS cotton a Peak (ppb) 21-day (ppb) 60-day (ppb) Water column 1.62 0.219 0.133

Pore water 0.0476 0.0442 0.0379

a. A chosen representative scenario for ag ricultural applications of cyfluthrin.

Table 2. Previously Generated a EECs for Cyfluthrin MS cotton b Peak (ppb) 21-day (ppb) 60-day (ppb) Water column 2.67 0.366 0.240 Sediment 85.7 Not Available Not Available

a. At the time there was no aerobic aquatic metabolism study for cyfluthrin and the v. 2 (instead of 2.1) of the input parameter guidance was used. Also, the date of application was different. b. A chosen representative scenario for agricultural applications of cyfluthrin.

Table 3. Input Parameters Utilized in Test Run in PRZM/EXAMS for Cyfluthrin 1 Parameter (units) Value(s) Sources Comments Output File Name CYFLUTHRIN --- --- Chemical Name Cyfluthrin Label e.g. , label BAYTHROID® 2 Emulsifiable Pyrethroid Insecticide (Reg. No. 264-745) Crop Names MS cotton Label Vulnerable s cenario, located in Yazoo, MS. Application Rate 0.056 Kg a.i./ha Label 0.05 lb a.i./ADay of Application (daymonth) 01-07 Label and metadata file ---

Number of Applications Allowed 10 Label Maximum allowed by the label.

Interval between Applications (days) 3 Label Minimum allowed by the label.

K OC (ml/g OC ) K OC = 123,950 MRID: 43424901 Mean of 4 values available (124000, 180300, 118000, 73500). The K OC model was utilized as per the 1999 SAP recommendation. Aerobic Soil Metabolism (days) t t t s

n input n    1 2 90 1
/ , ( )

t input = 116.9 days MRID: 00131494 Represents the 90 th percentile of the upper confidence bound on the mean of two half-life values: [values: 73.5, 94.8 days, mean = 84.15 days; std. dev. = 15.06 days,
t 90,n-1 = 3.078 for n=2] Method of Application Aerial Label --- Buffer Zone (ft.) 150 Label --- Application Efficiency (fraction) 0.95 Value for aerial applications ---

Spray Drift (fraction) 0.039 AgDRIFT, Tier II, default values Appropriate for a buffer zone of 150 ft. Solubility in Water (ppm) 2.32 x 10 -3 Laskowsky 2002 --- Aerobic Aquatic Metabolism (days) t t t s

n input n    1 2 90 1
/ , ( )

t input = 51.5 days MRID: 00131494 Represents the 90 th percentile of the upper confidence bound on the mean of two half-life values: [values: 32.9, 42.0 days, mean = 37.45 days; std. dev. = 6.435 days,
t 90,n-1 = 3.078 for n=2]. The value available is for beta -cyfluthrin.128 Table 3. Input Parameters Utilized in Test Run in PRZM/EXAMS for Cyfluthrin 1 Parameter (units) Value(s) Sources Comments Anaerobic Aquatic Metabolism (days) 60 MRID: 00131494 2x the anaerobic soil metabolism input value of ~30 days since there are no anaerobic aquatic studies Hydrolysis at pH 7 0 MRID: 00131493, 00137539, 45022101 Relatively stable at pH 7

Aqueous Photolysis (days) 4.5 MRID: 00149595, 45022102 Linear half-life

Molecular Weight (g/mole) 434.29 TOXNET/ HSDB --- Vapor Pressure (torr) 1.5 x 10 -8 Laskowsky 2002 --- Henry’s Law Constant (atm-m 3 /mol) 3.7 x 10 -6 Laskowsky 2002 ---

Environment pond298.exv --- Field Size EPA Pond --- Default for pond scenario, as opposed to index reservoir.

Runoff None --- --- PRZM Scenario MScottonSTD.txt --- --- Metfile w03940.dvf Meteorological file located in Jackson, MS. As suggested by the shell (PE5).

CAM (Chemical Application Method) 2 Foliar applied, linear application ---

Incorporation Depth (cm) 0 Label. Appropriate for foliar applications IPSCND, Condition for disposition of pesticide remaining on foliage after harvest 1 Surface applied ---

FEXTRC, Foliar extraction 0.5 Default value --- PLDKRT, Decay rate on foliage 0 --- ---

PLVKRT, Volatilization rate from foliage 0 --- ---

UPTKF, Uptake factor 0 --- --- Write benthic pore water concentrations? Yes --- ---

1 Data were selected according to EFED Guidance on Input Parameters v.2.1, dated October 22, 2009.

Output Files

stored as CYFLUTHRIN.out Chemical: Cyfluthrin PRZM environment: MScottonSTD.txt modified Tueday, 29 May 2007 at 13:57:52 EXAMS environment: pond298.exv modified Tueday, 26 August 2008 at 06:14:07 Metfile: w03940.dvf modified Tueday, 26 August 2008 at 06:14:14 Water segment concentrations (ppb)

Year Peak 96 hr 21 Day 60 Day 90 Day Yearly 1961 0.6178 0.3094 0.162 0.102 0.08218 0.0343 1962 0.6591 0.2084 0.07601 0.05536 0.05195 0.03778 1963 0.911 0.3007 0.1155 0.06369 0.04963 0.03501 1964 0.9171 0.3038 0.1429 0.09722 0.09244 0.0557 1965 1.632 0.7632 0.22 0.1224 0.1003 0.05414 1966 1.524 0.4941 0.1858 0.111 0.0928 0.0549 1967 0.9011 0.2868 0.1062 0.06934 0.06358 0.04478 1968 0.6025 0.2256 0.07806 0.0558 0.04871 0.04057 1969 1.259 0.3897 0.1171 0.07503 0.06445 0.04211 1970 0.9071 0.2927 0.1268 0.09624 0.08772 0.05173 1971 0.9291 0.4225 0.1755 0.1144 0.09702 0.05525 1972 0.2607 0.1029 0.07317 0.04625 0.0406 0.03489 1973 0.5963 0.1876 0.06612 0.0571 0.04712 0.03802 1974 0.5758 0.253 0.1194 0.08554 0.07335 0.04889 1975 2.713 0.8339 0.3188 0.1766 0.1442 0.06754 1976 0.9399 0.3433 0.1508 0.09414 0.08522 0.05163 1977 0.9897 0.3348 0.1175 0.08002 0.07362 0.05088129 1978 0.5457 0.1733 0.08854 0.05528 0.05214 0.04083 1979 1.099 0.4613 0.2091 0.1606 0.1375 0.0712 1980 0.2746 0.1082 0.06339 0.04832 0.04594 0.03503 1981 0.8641 0.2717 0.08954 0.0681 0.06028 0.04152 1982 1.34 0.4465 0.224 0.1337 0.1095 0.05912 1983 1.225 0.3769 0.114 0.06972 0.06131 0.04518 1984 1.067 0.4438 0.1449 0.09657 0.08231 0.05545 1985 2.131 0.6539 0.195 0.1105 0.09557 0.05404 1986 0.8161 0.2788 0.1054 0.06535 0.05894 0.04367 1987 0.5517 0.178 0.08578 0.05896 0.04898 0.03776 1988 0.8348 0.2619 0.08565 0.06797 0.06376 0.04412 1989 0.6678 0.2332 0.0939 0.07086 0.0664 0.04639 1990 0.7366 0.2281 0.1023 0.05905 0.05797 0.04412

Sorted results Prob. Peak 96 hr 21 Day 60 Day 90 Day Yearly 0.032258064516129 2.713 0.8339 0.3188 0.1766 0.1442 0.0712 0.0645161290322581 2.131 0.7632 0.224 0.1606 0.1375 0.06754 0.0967741935483871 1.632 0.6539 0.22 0.1337 0.1095 0.05912 0.129032258064516 1.524 0.4941 0.2091 0.1224 0.1003 0.0557 0.161290322580645 1.34 0.4613 0.195 0.1144 0.09702 0.05545 0.193548387096774 1.259 0.4465 0.1858 0.111 0.09557 0.05525 0.225806451612903 1.225 0.4438 0.1755 0.1105 0.0928 0.0549 0.258064516129032 1.099 0.4225 0.162 0.102 0.09244 0.05414 0.290322580645161 1.067 0.3897 0.1508 0.09722 0.08772 0.05404 0.32258064516129 0.9897 0.3769 0.1449 0.09657 0.08522 0.05173 0.354838709677419 0.9399 0.3433 0.1429 0.09624 0.08231 0.05163 0.387096774193548 0.9291 0.3348 0.1268 0.09414 0.08218 0.05088 0.419354838709677 0.9171 0.3094 0.1194 0.08554 0.07362 0.04889 0.451612903225806 0.911 0.3038 0.1175 0.08002 0.07335 0.04639 0.483870967741936 0.9071 0.3007 0.1171 0.07503 0.0664 0.04518 0.516129032258065 0.9011 0.2927 0.1155 0.07086 0.06445 0.04478 0.548387096774194 0.8641 0.2868 0.114 0.06972 0.06376 0.04412 0.580645161290323 0.8348 0.2788 0.1062 0.06934 0.06358 0.04412 0.612903225806452 0.8161 0.2717 0.1054 0.0681 0.06131 0.04367 0.645161290322581 0.7366 0.2619 0.1023 0.06797 0.06028 0.04211 0.67741935483871 0.6678 0.253 0.0939 0.06535 0.05894 0.04152 0.709677419354839 0.6591 0.2332 0.08954 0.06369 0.05797 0.04083 0.741935483870968 0.6178 0.2281 0.08854 0.05905 0.05214 0.04057 0.774193548387097 0.6025 0.2256 0.08578 0.05896 0.05195 0.03802 0.806451612903226 0.5963 0.2084 0.08565 0.0571 0.04963 0.03778 0.838709677419355 0.5758 0.1876 0.07806 0.0558 0.04898 0.03776 0.870967741935484 0.5517 0.178 0.07601 0.05536 0.04871 0.03503 0.903225806451613 0.5457 0.1733 0.07317 0.05528 0.04712 0.03501 0.935483870967742 0.2746 0.1082 0.06612 0.04832 0.04594 0.03489 0.967741935483871 0.2607 0.1029 0.06339 0.04625 0.0406 0.0343

0.1 1.6212 0.63792 0.21891 0.13257 0.10858 0.058778 Average of yearly averages: 0.0472183333333333

Inputs generated by pe5.pl - Novemeber 2006

Data used for this run: Output File: CYFLUTHRIN Metfile: w03940.dvf PRZM scenario: MScottonSTD.txt EXAMS environment file: pond298.exv Chemical Name: Cyfluthrin Description Variable Name Value Units Comments Molecular weight mwt 434.29 g/mol Henry's Law Const. henry 3.7e-6 atm-m^3/mol Vapor Pressure vapr 1.5e-8 torr Solubility sol 2.32e-3 mg/L Kd Kd mg/L Koc Koc 123950 mg/L Photolysis half-life kdp 4.5 days Half-life Aerobic Aquatic Metabolism kbacw 51.5 days Halfife Anaerobic Aquatic Metabolism kbacs 60 days Halfife Aerobic Soil Metabolism asm 116.9 days Halfife Hydrolysis: pH 7 0 days Half-life Method: CAM 2 integer See PRZM manual130 Incorporation Depth: DEPI 0 cm Application Rate: TAPP 0.056 kg/ha Application Efficiency: APPEFF 0.95 fraction Spray Drift DRFT 0.039 fraction of application rate applied to pond Application Date Date 01-07 dd/mm or dd/mmm or dd-mm or dd-mmm Interval 1 interval 3 days Set to 0 or delete line for single app. app. rate 1 apprate 0.056 kg/ha Interval 2 interval 3 days Set to 0 or delete line for single app. app. rate 2 apprate 0.056 kg/ha Interval 3 interval 3 days Set to 0 or delete line for single app. app. rate 3 apprate 0.056 kg/ha Interval 4 interval 3 days Set to 0 or delete line for single app. app. rate 4 apprate 0.056 kg/ha Interval 5 interval 3 days Set to 0 or delete line for single app. app. rate 5 apprate 0.056 kg/ha Interval 6 interval 3 days Set to 0 or delete line for single app. app. rate 6 apprate 0.056 kg/ha Interval 7 interval 3 days Set to 0 or delete line for single app. app. rate 7 apprate 0.056 kg/ha Interval 8 interval 3 days Set to 0 or delete line for single app. app. rate 8 apprate 0.056 kg/ha Interval 9 interval 3 days Set to 0 or delete line for single app. app. rate 9 apprate 0.056 kg/ha Record 17: FILTRA IPSCND 1
UPTKF Record 18: PLVKRT
PLDKRT FEXTRC 0.5 Flag for Index Res. Run IR EPA Pond Flag for runoff calc. RUNOFF none none, monthly or total(average of entire run)

stored as CYFLUTHRINben.out Chemical: Cyfluthrin PRZM environment: MScottonSTD.txt modified Tueday, 29 May 2007 at 13:57:52 EXAMS environment: pond298.exv modified Tueday, 26 August 2008 at 06:14:07 Metfile: w03940.dvf modified Tueday, 26 August 2008 at 06:14:14 Benthic segment concentrations (ppb)

Year Peak 96 hr 21 Day 60 Day 90 Day Yearly 1961 0.02832 0.02808 0.02701 0.02551 0.0234 0.01068 1962 0.02547 0.02532 0.02486 0.02336 0.02192 0.01519 1963 0.01997 0.01986 0.01957 0.01728 0.01656 0.01296 1964 0.03422 0.03396 0.03246 0.02953 0.02897 0.02055 1965 0.04702 0.0467 0.04351 0.03803 0.03485 0.02125 1966 0.04231 0.04202 0.03923 0.03371 0.03075 0.02171 1967 0.02597 0.02581 0.02514 0.02282 0.02185 0.01734 1968 0.02561 0.02556 0.02514 0.02428 0.0233 0.01637 1969 0.02866 0.02845 0.0262 0.02191 0.01978 0.01568 1970 0.03352 0.03334 0.03227 0.03062 0.02962 0.01984 1971 0.03635 0.03606 0.0345 0.03061 0.02967 0.02113 1972 0.02342 0.02327 0.02281 0.02125 0.02001 0.01347 1973 0.02372 0.02365 0.02156 0.02087 0.01984 0.01441 1974 0.02815 0.02798 0.02708 0.02636 0.02508 0.01878 1975 0.06133 0.06089 0.05683 0.04914 0.04446 0.02577 1976 0.03603 0.03578 0.03391 0.03084 0.0291 0.02021 1977 0.02684 0.02663 0.02549 0.02428 0.02319 0.01951 1978 0.0246 0.0244 0.02382 0.02237 0.0215 0.01576 1979 0.05109 0.05071 0.04708 0.04272 0.04085 0.02729 1980 0.0263 0.02611 0.02545 0.02399 0.02275 0.01437 1981 0.02452 0.02442 0.02343 0.02178 0.02051 0.01534 1982 0.04762 0.04716 0.04426 0.0366 0.03338 0.02212 1983 0.02793 0.02788 0.02756 0.02305 0.02068 0.01711 1984 0.03618 0.03592 0.03307 0.02787 0.02693 0.02169 1985 0.04408 0.04378 0.0404 0.0344 0.03183 0.02087 1986 0.02392 0.02383 0.02344 0.02223 0.02061 0.01662 1987 0.02255 0.02242 0.02202 0.02125 0.02038 0.01492 1988 0.02533 0.02522 0.02476 0.02377 0.02301 0.01637131 1989 0.02732 0.02723 0.02686 0.02588 0.0241 0.01798 1990 0.02777 0.02769 0.02723 0.02639 0.0249 0.01726

Sorted results Prob. Peak 96 hr 21 Day 60 Day 90 Day Yearly 0.032258064516129 0.06133 0.06089 0.05683 0.04914 0.04446 0.02729 0.0645161290322581 0.05109 0.05071 0.04708 0.04272 0.04085 0.02577 0.0967741935483871 0.04762 0.04716 0.04426 0.03803 0.03485 0.02212 0.129032258064516 0.04702 0.0467 0.04351 0.0366 0.03338 0.02171 0.161290322580645 0.04408 0.04378 0.0404 0.0344 0.03183 0.02169 0.193548387096774 0.04231 0.04202 0.03923 0.03371 0.03075 0.02125 0.225806451612903 0.03635 0.03606 0.0345 0.03084 0.02967 0.02113 0.258064516129032 0.03618 0.03592 0.03391 0.03062 0.02962 0.02087 0.290322580645161 0.03603 0.03578 0.03307 0.03061 0.0291 0.02055 0.32258064516129 0.03422 0.03396 0.03246 0.02953 0.02897 0.02021 0.354838709677419 0.03352 0.03334 0.03227 0.02787 0.02693 0.01984 0.387096774193548 0.02866 0.02845 0.02756 0.02639 0.02508 0.01951 0.419354838709677 0.02832 0.02808 0.02723 0.02636 0.0249 0.01878 0.451612903225806 0.02815 0.02798 0.02708 0.02588 0.0241 0.01798 0.483870967741936 0.02793 0.02788 0.02701 0.02551 0.0234 0.01734 0.516129032258065 0.02777 0.02769 0.02686 0.02428 0.0233 0.01726 0.548387096774194 0.02732 0.02723 0.0262 0.02428 0.02319 0.01711 0.580645161290323 0.02684 0.02663 0.02549 0.02399 0.02301 0.01662 0.612903225806452 0.0263 0.02611 0.02545 0.02377 0.02275 0.01637 0.645161290322581 0.02597 0.02581 0.02514 0.02336 0.02192 0.01637 0.67741935483871 0.02561 0.02556 0.02514 0.02305 0.02185 0.01576 0.709677419354839 0.02547 0.02532 0.02486 0.02282 0.0215 0.01568 0.741935483870968 0.02533 0.02522 0.02476 0.02237 0.02068 0.01534 0.774193548387097 0.0246 0.02442 0.02382 0.02223 0.02061 0.01519 0.806451612903226 0.02452 0.0244 0.02344 0.02191 0.02051 0.01492 0.838709677419355 0.02392 0.02383 0.02343 0.02178 0.02038 0.01441 0.870967741935484 0.02372 0.02365 0.02281 0.02125 0.02001 0.01437 0.903225806451613 0.02342 0.02327 0.02202 0.02125 0.01984 0.01347 0.935483870967742 0.02255 0.02242 0.02156 0.02087 0.01978 0.01296 0.967741935483871 0.01997 0.01986 0.01957 0.01728 0.01656 0.01068

0.1 0.04756 0.047114 0.044185 0.037887 0.034703 0.022079 Average of yearly averages: 0.018085

Inputs generated by pe5.pl - Novemeber 2006

Data used for this run: Output File: CYFLUTHRIN Metfile: w03940.dvf PRZM scenario: MScottonSTD.txt EXAMS environment file: pond298.exv Chemical Name: Cyfluthrin Description Variable Name Value Units Comments Molecular weight mwt 434.29 g/mol Henry's Law Const. henry 3.7e-6 atm-m^3/mol Vapor Pressure vapr 1.5e-8 torr Solubility sol 2.32e-3 mg/L Kd Kd mg/L Koc Koc 123950 mg/L Photolysis half-life kdp 4.5 days Half-life Aerobic Aquatic Metabolism kbacw 51.5 days Halfife Anaerobic Aquatic Metabolism kbacs 60 days Halfife Aerobic Soil Metabolism asm 116.9 days Halfife Hydrolysis: pH 7 0 days Half-life Method: CAM 2 integer See PRZM manual Incorporation Depth: DEPI 0 cm Application Rate: TAPP 0.056 kg/ha Application Efficiency: APPEFF 0.95 fraction Spray Drift DRFT 0.039 fraction of application rate applied to pond Application Date Date 01-07 dd/mm or dd/mmm or dd-mm or dd-mmm Interval 1 interval 3 days Set to 0 or delete line for single app. app. rate 1 apprate 0.056 kg/ha Interval 2 interval 3 days Set to 0 or delete line for single app. app. rate 2 apprate 0.056 kg/ha Interval 3 interval 3 days Set to 0 or delete line for single app. app. rate 3 apprate 0.056 kg/ha132 Interval 4 interval 3 days Set to 0 or delete line for single app. app. rate 4 apprate 0.056 kg/ha Interval 5 interval 3 days Set to 0 or delete line for single app. app. rate 5 apprate 0.056 kg/ha Interval 6 interval 3 days Set to 0 or delete line for single app. app. rate 6 apprate 0.056 kg/ha Interval 7 interval 3 days Set to 0 or delete line for single app. app. rate 7 apprate 0.056 kg/ha Interval 8 interval 3 days Set to 0 or delete line for single app. app. rate 8 apprate 0.056 kg/ha Interval 9 interval 3 days Set to 0 or delete line for single app. app. rate 9 apprate 0.056 kg/ha Record 17: FILTRA IPSCND 1
UPTKF Record 18: PLVKRT
PLDKRT FEXTRC 0.5 Flag for Index Res. Run IR EPA Pond Flag for runoff calc. RUNOFF none none, monthly or total(average of entire run)