b. Determination of Safety to U. S. Population The Agency has determined that the established tolerance for resmethrin, with amendments and changes as specified in this document, meets the safety standards under the FQPA amendments to section 408( b)( 2)( D) of the FFDCA, as amended by FQPA, and that there is a reasonable certainty no harm will result to the general population or any major identifiable subgroup from the use of resmethrin. In reaching this conclusion, the Agency has considered all available information on the toxicity, use practices, and the environmental behavior of resmethrin. As discussed in Section III, aggregate short, intermediate, and long term risks from food, drinking water, and residential exposures are below the Agency's LOC.

c. Determination of Safety to Infants and Children EPA has determined that the established tolerance for resmethrin, with amendments and changes as specified in this document, meets the safety standards under the FQPA amendments to section 408( b)( 2)( C) of the FFDCA, and that there is a reasonable certainty of no harm for infants and children. The safety determination for infants and children considers factors on the toxicity, use practices and environmental behavior noted above for the general population, but also takes into account the possibility of increased dietary exposure due to the specific consumption patterns of infants and children, as well as the possibility of increased susceptibility to the toxic effects of resmethrin residues in this population subgroup. In determining whether or not infants and children are particularly susceptible to toxic effects from exposure to residues of resmethrin, the Agency considered the completeness of the hazard database for developmental and reproductive effects, the nature of the effects observed, and other information. The FQPA Safety Factor has been retained at 10X. There are no residual uncertainties for pre and/ or post natal toxicity, exposure is not underestimated, and there is no evidence of increased susceptibility. However, an FQPA safety factor due to database uncertainty is retained at 10X to account for lack of a developmental neurotoxicity study.

2. Endocrine Disruptor Effects EPA is required under the FFDCA, as amended by FQPA, to develop a screening program to determine whether certain substances ( including all pesticide active and other ingredients) " may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or other endocrine effects as the Administrator may designate." Following recommendations of its Endocrine Disruptor Screening and Testing Advisory Committee ( EDSTAC), EPA determined that there was a scientific basis for including, as part of the program, the androgen and thyroid hormone systems, in addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation 53 that EPA include evaluations of potential effects in wildlife. For pesticides, EPA will use FIFRA and, to the extent that effects in wildlife may help determine whether a substance may have an effect in humans, FFDCA authority to require the wildlife evaluations. As the science develops and resources allow, screening of additional hormone systems may be added to the Endocrine Disruptor Screening Program ( EDSP). In the available toxicity studies on resmethrin submitted for registration purposes, there was no estrogen, androgen, and/ or thyroid mediated toxicity. When the appropriate screening and/ or testing protocols being considered under the EDSP have been developed, resmethrin may be subject to additional screening and/ or testing.

3. Cumulative Risks Resmethrin is a member of the pyrethroid class of pesticides. Although all pyrethroids alter nerve function by modifying the normal biochemistry and physiology of nerve membrane sodium channels, EPA is not currently following a cumulative risk approach based on a common mechanism of toxicity for the pyrethroids. Although all pyrethroids because there are multiple types of sodium channels, and it is currently unknown whether all pyrethroids have similar effects on all channels. In addition, the Agency does not have a clear understanding of effects on key downstream neuronal function, e. g., nerve excitability, nor do we understand how these key events interact to produce their compound specific patterns of neurotoxicity. There is ongoing research by both EPA's Office of Research and Development and the pyrethroid registrants to evaluate the differential biochemical and physiological actions of pyrethroids in mammals. This research is expected to be completed by 2007. When the results of this research are available, the Agency will make a determination of common mechanism of toxicity as a basis for assessing cumulative risk. For information regarding EPA's procedures for cumulating effects from substances found to have a common mechanism of toxicity, see EPA's website at http:// www. epa. gov/ pesticides/ cumulative/.

C. Tolerance Reassessment Summary Table 23. Tolerance Reassessment Summary for Resmethrin ( 40 CFR § 180.525) Commodity Current Tolerance ( ppm) Range of Residues ( ppm) Tolerance Reassessment ( ppm) Comment/[ Correct Commodity Definition]

Food items 3.0 < 0.003 0.377 1 To be determined Additional information/ data are required to upgrade the existing study supporting the use of resmethrin as a crack and crevice treatment, and new studies are required supporting space treatment uses in food and feed handling establishments. 1 Resmethrin residues in/ on representative food commodities following crack and crevice treatment to representative types of food handling establishments.

There are no dietary or aggregate risk concerns associated with the current tolerance and EPA considers it reassessed at the current tolerance level. However, additional data are necessary to confirm this tolerance level is appropriate for resmethrin. 54 There are currently no Codex or Canadian MRLs for resmethrin.

D. Regulatory Rationale The Agency has determined that resmethrin is eligible for reregistration provided that the risk mitigation measures and label amendments specified in the RED are implemented. The following is a summary of the rationale for managing risks associated with the use of resmethrin.

1. Human Health Risk a. Dietary ( Food + Drinking Water) Risk Non Cancer Dietary Risk There are no resmethrin non cancer dietary ( food + drinking water) risks that exceed the Agency's level of concern. This assessment is protective of the general U. S. population and all population subgroups, including infants and children. Therefore, no mitigation is necessary for these scenarios.

Cancer Dietary Risk A slightly refined cancer dietary risk assessment was conducted for all supported resmethrin food uses. When both detections and non detections are included in the resmethrin cancer dietary analysis, and the percentage of food handling establishment treated is conservatively estimated to be 10%, dietary and drinking water risks are not of concern to the Agency ( lifetime dietary cancer risk for the general U. S. population is 1.6 x 10 6). Food risks are only slightly refined, which results in high end estimates of exposures to residues in food. Additionally, the LOD was used as the residue value for all non detections in a crack and crevice residue study with resmethrin. This also is an overestimation of exposure. Drinking water exposure estimates were developed using the tier 2 model PRZM EXAMs, which also results in high end estimates of potential exposure to resmethrin. No mitigation is necessary for this scenario.

b. Residential Risk Non Cancer Residential Risk Most estimates for residential risk are below EPA's level of concern. All residential risks are below the Agency's level of concern ( MOEs are above 1000), except for post application risk for a child exposed to indoor aerosol space sprays.

The non cancer post application inhalation risk estimate for a child exposed to an indoor aerosol space spray exceeds the Agency's level of concern with an MOE of 900. For the non cancer post application inhalation risk estimate, the Agency assumed that one 16 oz spray can containing 0.2% ai was used per application. This exposure may occur when a child enters a room within 10 minutes after a resmethrin indoor aerosol space spray application. Potential risk is below the Agency's level of concern if a child 55 waits 2 hours before entering a room where resmethrin has been applied as an indoor aerosol space spray. In order to mitigate this inhalation risk, resmethrin products applied as indoor aerosol space sprays must be labeled to instruct users to keep all people and pets out of sprayed rooms for 2 hours after application. When residents stay out of sprayed rooms for 2 hours, the post application MOE for a child is 3500 which is below the Agency's level of concern for residential exposure. No additional mitigation is needed for this scenario.

Cancer Residential Risk There are no residential cancer risks of concern when resmethrin is handled by residents or applied to residential areas. Residential handler risk, bystander risk, and residential post application risk are below the Agency's level of concern for all scenarios. Additionally, the residential handler scenario with the highest exposure and risk ( indoor aerosol space spray) was assumed to occur three times a year for 70 years. No mitigation is necessary for these scenarios.

c. Aggregate ( Food + Drinking Water + Residential) Risk Non Cancer Aggregate Risk Non cancer residential risks cannot be aggregated with the resmethrin non cancer assessment for food and drinking water because the toxicity endpoints for residential dietary, incidental oral, dermal, and inhalation exposures are not based on common effects. Therefore, no non cancer aggregate risk assessment was conducted for resmethrin, other than the previously described aggregate assessment of food and drinking water.

Cancer Aggregate Risk For the cancer aggregate risk analysis, a slightly refined dietary assessment was combined with the residential cancer risk scenario with the highest exposure and risk ( residential indoor aerosol spray application). The slightly refined dietary assessment risk estimate was 1.6 x 10 6, and the residential indoor aerosol spray application risk estimate was 1.0 x 10 6 when residents wait 2 hours before re entering the space that was sprayed. The residential exposure scenario which was aggregated with dietary risks is the one with the highest estimated exposure and risk ( indoor aerosol space spray) of all the residential scenarios assessed. EPA believes the estimated risks for each pathway of exposure ( food, drinking water, and residential) are greater than what people are likely to experience, and the probability of people experiencing all these high end exposures together over the course of a lifetime is low. When these scenarios are combined, the aggregate cancer risk estimate is 2.6 x 10 6, which is within an acceptable range.

Because the residential indoor aerosol spray application risk estimate is dependant upon residents not entering sprayed spaces for 2 hours after application, a statement must be placed on aerosol space spray residential labels indicating that residents must not enter fogged spaces for 2 hours after application. A ventilation requirement will also be required on labels indicating that residents must ventilate the sprayed space for 10 minutes with fresh air before occupying the room. Similar label requirements must also 56 be placed on labels of products used by pest control operators ( PCOs) that they must inform residents to not enter sprayed spaces for 4 hours and ventilate for 20 120 minutes depending on the size of the treated area before occupying the sprayed space. No additional mitigation is necessary for these scenarios.

d. Occupational Risk Non Cancer Occupational Risk Concerns for workers mixing, loading, and applying the liquid formulations of resmethrin can be mitigated with PPE. All mixers, loaders, and appliers using liquid formulations of resmethrin are required to wear gloves for dermal protection. In addition, workers using foggers in indoor spaces are required to wear respirators for protection against potential inhalation risk and coveralls for protection against potential dermal risk. All applicators and other handlers using ready to use aerosol formulations will be required to wear gloves. For products intended only for wide area mosquito abatement programs, chemical resistant gloves are required for all handlers except applicators.

Cancer Occupational Risk There are some concerns for workers when mixing, loading, and applying the liquid formulations of resmethrin. All mixers, loaders, and appliers using liquid formulations of resmethrin are required to wear gloves for dermal protection. In addition, workers using foggers in indoor spaces are required to wear respirators for protection against potential inhalation risk and coveralls for protection against potential dermal risk. All applicators and other handlers using ready to use aerosol formulations will be required to wear gloves. For products intended only for wide area mosquito abatement programs, chemical resistant gloves are required for all handlers except applicators.

Exposure Reduction The Agency incident report recommends appropriate respiratory protective equipment for individuals who are likely to have substantial contact with resmethrin. Because mosquito abatement handlers may be exposed to resmethrin on a regular basis, enclosed cabs are required for ULV truck mounted mosquito abatement spray applications, and enclosed cockpits are required for ULV aerial mosquito abatement spray applications. Additionally, as mentioned above, workers using foggers in indoor spaces must wear respirators for protection from inhalation risk and coveralls for protection from dermal risk.

A 12 hour REI is required for workers re entering treated greenhouses after resmethrin applications. In addition, workers who enter a resmethrin treated greenhouse before the REI has expired must wear coveralls over long sleeve shirt and long pants, chemical resistant gloves made of any waterproof material, and shoes plus socks.

2. Environmental Risk The Agency has conducted a screening level ecological risk assessment for the mosquito control use of resmethrin based on application of resmethrin to Florida turf. 57 Based on the available data, the Agency has identified potential acute and chronic risks of concern to freshwater fish, potential acute risks estuarine/ marine fish, acute risks and potential chronic risks to freshwater and estuarine/ marine invertebrates, and freshwater and estuarine/ marine benthic organisms. Available data show potential acute and chronic risks to birds when a dose based study is used. When a dietary based study is used, acute and chronic risks to birds are considered not likely. There are no acute or chronic effects to mammals, aquatic plants, or terrestrial plants exposed to resmethrin when it is applied as a wide area mosquito abatement spray as modeled in the environmental fate and effects assessment.

While there are slight estimated exceedances of the LOCs for some terrestrial and aquatic species, based on its use pattern and usage information the ecological risks associated with resmethrin are expected to be limited. Resmethrin is used for wide area ULV mosquito abatement, in and around homes, commercial establishments, industrial areas, and food handling establishments to treat flying and crawling insects, and by pet groomers, veterinarians, and citizens for insect control on livestock and pets. Resmethrin use is estimated at 50,000 lbs per year, with over half of those pounds applied per year used for mosquito control.

Release height restrictions on resmethrin aerial mosquitocide applications will reduce wildlife exposure. RQs were estimated with a 25 foot aerial boom height. The resmethrin registrants have agreed to nozzle heights of no less than 100 feet above ground or canopy for fixed wing applicators and no less than 75 feet above ground or canopy for rotary wing applicators. The higher release heights will reduce wildlife exposure to resmethrin.

The registrants for resmethrin have also agreed to set new application rates for resmethrin. Previously, resmethrin labels had often not specified application rates. The rates listed below will serve as maximum application rates for reregistered resmethrin products.

  Products labeled for use on Livestock, Farm Animals, and Pets ( Direct Application): Product must contain 0.35% ai. or less.

  Products labeled for use in Outdoor Sites ( Commercial, Recreational, Domestic Outdoor Sites, Agricultural Structures, Agricultural Premises, and Agricultural Equipment): 0.25 lb ai per acre.

  Products labeled for use in Space Applications ( Indoor Food Handling/ Processing/ Eating Establishments; Commercial Structure Premises and Equipment; Domestic Structure Premises and Equipment): 0.001 lb ai per 1000 ft2.

  Products labeled for use in Surface Crack and Crevice Application ( Indoor Food Handling/ Processing/ Eating Establishments; Commercial Structure Premises and Equipment; Domestic Structure Premises and Equipment): 0.242 lb ai per 1000 ft2.

Additionally, wide area mosquito control products must contain the following requirements: 58   Products labeled for wide area mosquito abatement must state a maximum application rate of 0.007 lb ai/ acre, and state a maximum yearly application limit of 0.2 lb ai/ acre.   Release height requirement for rotary wing of no less than 75 feet above the ground or canopy, for fixed wing of no less than 100 feet above the ground or canopy.   Must contain environmental hazard statements informing user of toxicity to fish, aquatic invertebrates, and oysters/ shrimp.   Must contain a statement informing user of toxicity to bees visiting treated area.   Must be in compliance with EPA PR Notice 2005 1.

Stewardship Language The Agency cannot currently fully assess the potential risks to aquatic organisms from resmethrin use around the home. Therefore to lessen potential risks the Agency is seeking to reduce the drift and run off of resmethrin into aquatic habits through explicit directions for use on both professional and consumer use products for use in residential settings. These use directions include best management and stewardship practices which are formulation specific, and will serve to reduce the potential run off and drift that can occur from applications of these products. Label statements implementing these measures are listed in the Label Changes Summary Table in Section V of this RED document.

a. Fish and Aquatic Invertebrate Risk The following summary of ecological concerns does not reflect all of the mitigation measures mentioned above. Thus, the actual exposure to resmethrin will be less for all non target species than current estimates reflect.

Acute and Chronic Freshwater and Estuarine/ Marine Fish For freshwater fish, the highest acute RQ value is 2.8 for freshwater fish in water 2 meters deep. This exceeds the acute risk LOC of 0.5 and the acute endangered species LOC of 0.05 and is of concern. The RQ decreases in shallow water because resmethrin is broken down through aqueous photolysis, and more light is available in shallow water. The RQ value for chronic risk to freshwater fish is 1.7 for fish exposed to the TGAI in a water body 2 meters deep at a 3 day application interval. This exceeds the chronic risk LOC of 1. When a release height of 75 feet for aerial applications is considered, the RQs for freshwater fish decrease to an acute RQ of 0.75 and a chronic RQ of 0.51. Thus, when the release height of 75 feet is considered, the acute risk level is still of concern, but the freshwater chronic risk level is no longer of concern.

For estuarine/ marine fish, the RQ value does not exceed the acute risk LOC ( 0.5). However, the acute endangered species LOC ( 0.05) is exceeded for estuarine/ marine fish ( estimated value of 0.48 for formulated resmethrin). When a release height of 75 feet for aerial applications is considered, the acute RQ decreases to 0.13, which is still above the acute endangered species LOC. Chronic risks of concern for estuarine/ marine fish are not likely ( RQs range from 0.02 to 0.29, therefore less than the chronic LOC of 1). 59 Acute and Chronic Freshwater and Estuarine/ Marine Invertebrates For freshwater invertebrates, the acute RQ value exceeds the acute risk LOC ( 0.5) and acute endangered species LOC ( 0.05) for resmethrin formulated products with an estimated RQ value of 6.5. When a release height of 75 feet is considered for aerial applications, the acute RQ decreases to 1.74, which is still above the acute risk and acute endangered species LOCs. Chronic resmethrin exposure to freshwater invertebrate data was not available, but chronic data from a similar pesticide, the pyrethrins, shows reproductive effects in freshwater invertebrates with a NOAEC value of 0.86 ppb. This may indicate potential chronic risk for freshwater invertebrates exposed to resmethrin.

For estuarine/ marine invertebrates, the maximum acute RQ value exceeds the acute risk LOC ( 0.5) and acute endangered species LOC ( 0.05) at 3.4 when estuarine/ marine invertebrates are exposed to formulated resmethrin. When a release height of 75 feet is considered for aerial applications, the acute RQ decreases to 0.91, which is a level that still exceeds the acute risk and acute endangered species LOCs. Chronic resmethrin exposure to esturarine/ marine invertebrates data was not available, but chronic data from a similar pesticide, the pyrethrins, shows reproductive effects in freshwater invertebrates with a NOAEC value of 0.86 ppb. This may indicate potential chronic risk for estuarine/ marine invertebrates exposed to resmethrin.

Acute and Chronic Freshwater and Estuarine/ Marine Benthic Organisms RQs for freshwater benthic organisms were calculated from water column studies in the absence of sediment toxicity data for resmethrin. The maximum acute RQ value does not exceed the acute risk LOC ( 0.5) at 0.11 for technical resmethrin, however this level does exceed the acute endangered species LOC of 0.05. Registrants have agreed to a release height of 75 for aerial mosquito applications. When this is taken into account for aerial applications, the RQ decreases to 0.03, which is below the acute endangered species LOC of 0.05. Therefore, acute risk is not likely to be of concern for freshwater benthic organisms exposed to resmethrin. No chronic freshwater or estuarine/ marine benthic organism data were submitted to the Agency. However, based on the potential for chronic risk to freshwater fish due to exposure to technical resmethrin, chronic invertebrate data from other synthetic pyrethroids, and the affinity of resmethrin to partition to sediment, there is potential for resmethrin to cause chronic effects in benthic organisms.

RQs for estuarine/ marine benthic organisms were calculated from water column studies in the absence of sediment toxicity data for resmethrin. The maximum acute RQ value does not exceed the acute risk LOC ( 0.5) at 0.26 for technical resmethrin. However, the acute RQ does exceed the acute endangered species LOC 0.05. When a release height of 75 feet is considered for aerial applications, the acute RQ decreases to 0.08, which is still slightly above the acute endangered species level of concern. No chronic freshwater or estuarine/ marine benthic organism data were submitted to the Agency. However, based on the potential for chronic risk to freshwater fish due to exposure to technical resmethrin, chronic invertebrate data from other synthetic 60 pyrethroids, and the affinity of resmethrin to partition to sediment, there is potential for resmethrin to cause chronic effects in benthic organisms.

Aquatic Plants No aquatic vascular or non vascular data plant data were submitted for resmethrin. However, the Agency has determined that resmethrin will have no effect on listed plants. It is unlikely that resmethrin poses a phytotoxic concern based on its neurotoxic mode of action, lack of toxic effects when plants are exposed to other pyrethroids, and lack of ecological incident reports for plants.

" Down the Drain" Assessment Acute and chronic RQs for freshwater and estuarine fish and invertebrates are below 0 and are therefore below the Agency's level of concern for acute risk ( 0.5) and chronic risk ( 1.0). Therefore, no mitigation is necessary at this time to address resmethrin risk to aquatic organisms around wastewater plant releases.

b. Avian Risk Terrestrial Birds When mean residues are considered, the acute use LOC ( 0.5) is not exceeded for birds that feed on short grass, tall grass, and broadleaf plants/ small insects when RQs are calculated with a dose based red winged blackbird study. The acute endangered species LOC of 0.1 is exceeded for 20g and 100g birds feed on short grass. The chronic LOC ( 1) is not exceeded for birds feeding on short grass, tall grass, and broadleaf plants/ small insects when the dose based study is used. The highest chronic RQ considering mean residues is 0.8.

When avian RQs are calculated with dietary based toxicity values, no LOCs are exceeded for any acute or chronic scenario.

c. Mammalian Risk Terrestrial Mammals All acute and chronic RQs are below the respective acute and chronic LOCs for mammalian risk. Therefore, resmethrin is not likely to pose an acute or chronic risk to mammals.

d. Terrestrial Plant Risk No terrestrial plant data were submitted to the Agency for resmethrin. However, the Agency has determined that resmethrin will have no effect on listed plants. It is unlikely that resmethrin poses a phytotoxic concern based on its neurotoxic mode of action, lack of toxic effects when plants are exposed to other pyrethroids, and lack of ecological incident reports for plants.

e. Non Target Insect Risk 61 Currently, the Agency does not estimate RQs for terrestrial non target insects. However, based on a single study in honey bees, technical resmethrin is classified as highly toxic on an acute contact basis to non target terrestrial insects ( LD50 = 0.063 ug/ ai per bee). Label statements addressing bee risk are required for all resmethrin occupational and wide area mosquito abatement products used outdoors.

3. Ongoing Work on Pyrethoids One of the risk assessment goals of the Office of Pesticide Programs ( OPP) is to estimate pesticide exposure through all significant routes of exposure from both agricultural and non crop uses. However, the ecological risk assessments for most pyrethroid insecticides focus predominantly on the agricultural uses for these insecticides, because pesticide transport models are available to estimate potential aquatic exposure. Based on laboratory toxicity tests with terrestrial and aquatic animals, aquatic exposure would be more likely to cause adverse effects in the environment.

However, sales data indicate that non crop uses of the pyrethroids comprise a much larger fraction of total use than agricultural uses. The use of pyrethroids in urban and suburban settings has increased since the phase out of these uses of the organophosphate insecticides diazinon and chlorpyrifos. Sales data indicate that the majority of urban use of pyrethroids is for structural pest control, such as for control of termites or ants. Other outdoor non crop uses include landscape maintenance, and homeowner lawn and garden use. Indoor uses include insect control, and treatment of pets and clothing.

The Agency uses a " down the drain" model to perform a screening level aquatic risk assessment for indoor uses of pesticides. In these simulations, waste water containing pesticide residue flows into a building drain and passes through a sanitary sewer and publicly owned treatment works ( POTW) before being discharged to surface water. However, no analogous exposure model has been developed to allow a similar screening level assessment for pesticides applied in an outdoor urban setting. As a result, the Agency has had to take a qualitative approach to characterize the potential aquatic risk from urban and suburban use of pyrethroids.

For outdoor urban uses, it is assumed that runoff water from rain and/ or lawn watering may transport pesticides to storm sewers and then directly to surface water. Conceptually, a greater contribution to pyrethroid loading to surface water bodies would be expected from application to impervious surfaces such as walkways, driveways or the sides of buildings, than to lawns or bare ground, because of the pyrethroids' strong affinity to bind to organic carbon in soils. However, the Agency is unaware of any model which can simulate the different application methods for urban use and the physical representation of the urban landscape, storm sewer and receiving water configuration.

There are models available which can be calibrated to simulate sites and pesticides for which extensive flow and pollutant data have been collected in advance. 62 The HSPF/ NPSM model, for instance, which is included in the Office of Water's BASINS shell, has been used to calibrate stream flow and copper pesticide use data to simulate loading of these pesticides consistent with concentrations measured in surface water monitoring. Risk assessors with the California Department of Environmental Protection confirmed in conversations with the Agency that they also have used watershed models to calibrate to previously collected flow and pesticide monitoring data, but that they did not know of any models capable of predicting concentrations of pyrethroids that might occur because of outdoor urban uses.

Development of a screening model which could simulate the fate and transport of pesticides applied in an urban setting would require a large body of data which is currently unavailable. For instance, an urban landscape cannot be simulated as easily as an agricultural field. The PRZM model simulates runoff from an agricultural field using readily available data describing surface soil characteristics and laboratory data detailing the persistence and mobility of pesticides in these soils. The agricultural field simulated is homogenously planted to a single crop, and soil and water are transported from the field to a receiving water body with dimensions consistent with USDA farm pond construction guidelines.

By contrast, an urban landscape or suburban housing development consists of impervious surfaces such as streets and sidewalks, and pervious surfaces such as lawns and parkland. One could expect much greater mobility for pesticides applied to impervious surfaces, but laboratory soil metabolism studies may not provide an accurate measure of the persistence of pesticides on these surfaces. The path runoff water and eroded sediment might take is less obvious for an urban setting than an agricultural field. First, an urban landscape cannot be considered homogeneous, as the proportion of impervious and pervious surfaces varies for different locations. In addition, the flow path of runoff water and sediment is not necessarily a direct path over land, but can pass below ground through storm sewer networks, or be directed or slowed by pumping stations or temporary holding ponds.

Finally, the timing and magnitude of urban uses is less well defined for urban uses than agricultural uses. While agricultural uses would occur within a predictable window during the growing season, the need for urban uses could occur at different times each year, and might occur at different times within the same watershed. In addition, since records of how and to what extent pyrethroids are applied by homeowners are less well defined than for professional applications, it is harder to estimate the total load to model.

Pyrethroid monitoring data The Agency considers surface water monitoring data in addition to modeling results when they are available. However, surface water monitoring for pyrethroids has been limited, perhaps because the pyrethroids would more likely be associated with aquatic sediment than the water column. The USGS NAWQA program included permethrin as the only pyrethroid among its pesticide analytes, and detected it in 0.15% of 1185 agricultural stream samples from 78 sample locations. Permethrin was not 63 detected in 803 urban stream samples taken from 33 sample locations. The NAWQA program also analyzed for cis permethrin in bed sediments, and had similar detection rates in between the agricultural ( 1.5%) and urban ( 1.0%) land use sites; trans permethrin was detected in 0.8% of bed sediment samples. Resmethrin was not detected in the USGS NAWQA survey.

More recently, researchers from the University of California Berkeley have published studies which reported transport of pyrethroids to stream bed sediment as a result of urban uses. In 2004, Weston, et al. collected sediment from creeks draining a residential area in Rosedale, California. The sediments were analyzed for 7 pyrethroids ( including permethrin and cypermethrin, which are currently in the reregistration process), as well as for other insecticides. The sediments were not analyzed for resmethrin. All of the pyrethroids were detected in the bed sediment from at least one sampling location. The researchers exposed the aquatic amphipod Hyalella azteca to the 21 sediment samples they collected; pesticide concentrations in 9 of these samples was sufficient to cause 90% mortality in the amphipods after a 10 day exposure. The concentrations of pyrethroids detected in the sediments were above the level expected to cause 50% mortality in H. azteca, suggesting that the pyrethroids were responsible for the observed toxicity.

In a subsequent study, Weston, et al. collected samples from 15 urban creeks in California and 12 in Tennessee. Toxicity to H. azteca was observed at least once with sediments taken from 12 of the 15 California sampling sites. In most cases, the toxicity could be accounted for by the concentrations of pyrethroids detected in the sediment. Pyrethroids were rarely detected in the Tennessee sediment samples, and exposure to the Tennessee sediments did not prove to be toxic to H. azteca.

Future steps The results of the Weston, et al. studies has led a number of organizations, such as the California State Water Resources Control Board ( SWRCB) to submit comments to the Agency during the reregistration process of several pyrethroid insecticides, calling for mitigation measures to prevent pyrethroid surface water contamination. However, the lack of knowledge which makes it difficult to develop an urban pesticide transport model also makes it difficult to identify meaningful mitigation at this time. The Agency has developed some initial mitigation options during the reregistration process, and intends to identify steps which can be taken to allow a greater understanding of potential ecological risk from urban pyrethroid uses.

One reason that broad mitigation measures cannot be adopted during reregistration is that only three pyrethroid insecticides are required to be reviewed for reregistration in accoradance with FQPA. If use restrictions were placed on one of these three pesticides, one of the other pyrethroids would likely replace it for that use. It is important, as some commenters have suggested, to perform a risk assessment for all of the pyrethroids at the same time. The Weston papers indicated that the sediments which proved toxic to the tested aquatic invertebrate were contaminated not only with the 64 pyrethroids undergoing reregistration, but also other pyrethroids such as bifenthrin and lambda cyhalothrin.

The next opportunity to assess the pyrethroids as a group will occur during the Registration Review program, for which the Agency issued a proposed rule in July 2005 and plans to issue the final rule and implement the program in 2006. The purpose of Registration Review is to ensure the periodic review of all pesticides to make sure they continue to meet current scientific and regulatory requirements, with the goal of reviewing each pesticide every fifteen years. The pyethroids are tentatively scheduled for re evaluation under the proposed Registration Review program in 2010.

A number of steps are planned for the intervening years which should improve the Agency's ability to assess the level of aquatic exposure to pyrethroids from urban use. One step is to better identify what conditions in an urban setting might lead to greater vulnerability to transport to urban water bodies. Although the Weston papers reported sediment toxicity from samples from California but not Tennesse, the authors could only speculate what differences in use or geography made an area more vulnerable to exposure than the other.

Further investigation into the dominant urban uses and application practices of pyrethroids around the country would help provide a clearer picture of relative vulnerability. The SWRCB commented that structural pest control is likely a major source of pyrethroids in urban runoff, and suggested best management practices ( BMP). The Pyrethroid Working Group ( PWG) indicated that irrigation of lawns in areas of California with little rainfall during the application season could be a major contributor, and has contacted organizations such as Responsible Industry for a Sound Environment ( RISE) and the Coalition for Urban/ Residential Environmental Stewardship ( CURES) to develop BMPs as part of their product stewardship plan. As further sediment monitoring studies are published describing parts of the country with different weather and pest pressures, more detailed usage data will make it easier to correlate the causes of pyrethroid use practices.

The Agency will also continue in its efforts to develop a screening level model for urban pesticide uses. Advances in the resolution of GIS databases may allow better representation of the impervious and pervious portions of a typical urban landscape. As it becomes clearer which uses are most likely to lead to transport of pyrethroids to surface water, the conceptual model of how urban transport should be simulated will be more focused.

Finally, the Agency will evaluate available published literature and call in data to resolve data gaps to ensure a robust comparison of the potential ecological risk of all the pyrethroids during Registration Review. Toxicity data cited by several commenters from published literature are included in the Agency's ECOTOX database. The Agency will evaluate the quality of studies to identify those to be included in the risk assessments during Registration Review. The PWG is currently performing specific toxicity studies identified by the Agency as data gaps, such as sediment invertebrate toxicity tests. 65 66 V. What Registrants Need to Do The Agency has determined that resmethrin is eligible for reregistration provided that the mitigation measures and label changes identified in this RED are implemented. Registrants will need to amend their product labeling to incorporate the label statements set forth in the Label Changes Summary Table ( table XX). The Agency intends to issue Data Call Ins ( DCIs) requiring generic and product specific data. Generally, the registrant will have 90 days from receipt of a DCI to complete and submit response forms or request time extensions and/ or waivers with a full written justification. For productspecific data, the registrant will have eight months to submit data and amended labels.

A. Manufacturing Use Products 1. Additional Generic Data Requirements The generic data base supporting the reregistration of resmethrin for currently registered uses has been reviewed and determined to be substantially complete. However, the data listed below are necessary to confirm the reregistration eligibility decision documented in this RED.

Table 24. Guideline Requirements for Resmethrin Data Requirement Old Guideline No. New OPPTS Guideline No.

Environmental Fate and Ecological Effects Data Requirements Photodegradation of parent and degradates in soil ( Photodegradation in Soil of Resmethrin) 161 3 835.2410 Aquatic invertebrate life cycle ( freshwater and estuarine/ marine invertebrates) 72 4 850.1350 850.1300 Acute sediment testing ( freshwater and estuarine/ marine) ( Freshwater held in reserve) 74 1 850.1735 850.1740 Chronic sediment testing ( freshwater and estuarine/ marine) EPA/ 600/ R 99/ 064 EPA/ 600/ R01/ 020 Avian reproduction test ( with bobwhite quail) 71 4 850.2300 Fish early life stage toxicity test ( freshwater and estuarine/ marine) 72 4 850.1400 Fish acute toxicity test ( freshwater and marine) 72 1 72 3 850.1075 Aquatic invertebrate acute toxicity test, freshwater daphnids 72 2 850.1010 Mysid acute toxicity test 72 3 850.1035 Bivalve acute toxicity test ( embryo larval) 72 3 850.1055 Oyster acute toxicity test ( shell deposition) 72 3 850.1025 Human Health Effects Data Requirements 90 Day neurotoxicity screening battery 870.6200b 67 Developmental neurotoxicity study 83 6 870.6300 Nature of the residue  plants 171 4 860.1300 Multiresidue Method 171 4 860.1360 Storage Stability Data 171 4 860.1380 Magnitude of the Residue   food handling   food items 171 4 860.1460 Magnitude of the Residue   meat, milk, poultry, eggs 171 4 860.1480 B. End Use Products 1. Additional Product Specific Data Requirements Section 4( g)( 2)( B) of FIFRA calls for the Agency to obtain any needed productspecific data regarding the pesticide after a determination of eligibility has been made. The registrant must review previous data submissions to ensure that they meet current EPA acceptance criteria and if not, commit to conduct new studies. If a registrant believes that previously submitted data meet current testing standards, then the study MRID numbers should be cited according to the instructions in the Requirement Status and Registrants Response Form provided for each product. The Agency intends to issue a separate product specific data call in ( PDCI) outlining specific data requirements.

2. Labeling for End Use Products To be eligible for reregistration, labeling changes are necessary to implement measures outlined in Section IV above. Specific language to incorporate these changes is specified in Table 25. Generally, conditions for the distribution and sale of products bearing old labels/ labeling will be established when the label changes are approved. However, specific existing stocks time frames will be established case by case, depending on the number of products involved, the number of label changes, and other factors. 68 69 Labeling Changes Summary Table In order to be eligible for reregistration, amend all product labels to incorporate the risk mitigation measures outlined in Section IV.

The following table describes how language on the labels should be amended.

Table 25: Summary of Labeling Changes for Resmethrin Description Manufacturing Use Products Placement on Label Formulation instructions required on all manufacturing use products " Only for formulation into an insecticide for the following use( s) [ fill blank only with those uses that are being supported by MP registrant]."

" Not for formulation into end use products for use in indoor metered spray systems."

" Not for formulation into end use products for use in outdoor misting systems." Directions for Use One of these statements may be added to a label to allow reformulation of the product for a specific use or all additional uses supported by a formulator or user group " This product may be used to formulate products for specific use( s) not listed on the MP label if the formulator, user group, or grower has complied with U. S. EPA submission requirements regarding support of such use( s)."

" This product may be used to formulate products for any additional use( s) not listed on the MP label if the formulator, user group, or grower has complied with U. S. EPA submission requirements regarding support of such use( s)." Directions for Use Environmental Hazards Statements Required by the RED and Agency Label Policies " Environmental Hazards This product is toxic to fish, aquatic invertebrates, and oysters/ shrimp. Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans, or other waters unless in accordance with the requirements of a National Pollution Discharge Elimination System ( NPDES) permit and the permitting authority has been notified in writing prior to discharge. Do not discharge effluent containing this product to sewer systems without previously notifying the local sewage treatment plant authority. For guidance contact your State Water Board or Regional Office of the EPA." Precautionary Statements 70 End Use Products Intended for Occupational Use Excludes Products Intended for Use in Wide Area Mosquito Abatement Programs ( See below requirements)

PPE Requirements Established by the RED1 for Liquid Formulations ( excludes formulations applied via ready to use aerosols) " Personal Protective Equipment ( PPE)

Some materials that are chemical resistant to this product are @ ( registrant inserts correct chemical resistant material). If you want more options, follow the instructions for category [ registrant inserts A, B, C, D, E, F, G, or H] on an EPA chemical resistance category selection chart.

All mixers, loaders, applicators, and other handlers must wear:

 long sleeved shirt and long pants,

 socks plus shoes, and  chemical resistant gloves.

Applicators using handheld fog equipment must wear:

 coveralls over long sleeved shirt and long pants,

 chemical resistant gloves,

 chemical resistant footwear plus socks,

 chemical resistant headgear, if overhead exposure,

 chemical resistant apron when mixing, loading, and cleaning equipment or spills, and  A NIOSH approved respriator with  a dust/ mist filter with MSHA/ NIOSH approval number prefix TC 21C or  any N* R, P, or He filter."

* Instruction to Registrant: Drop the " N" type prefilter from the respirator statement, if the pesticide product contains, or is used with, oil. Immediately following/ below Precautionary Statements:

Hazards to Humans and Domestic Animals PPE Requirements Established by the RED1 for Ready to use Aerosol Products " Personal Protective Equipment ( PPE)

Some materials that are chemical resistant to this product are @ ( registrant inserts correct chemical resistant material). If you want more options, follow the instructions for category [ registrant inserts A, B, C, D, E, F, G, or H] on an EPA chemical resistance category selection chart.

All applicators and other handlers must wear:

 long sleeved shirt, long pants, and  socks plus shoes, and Immediately following/ below Precautionary Statements:

Hazards to Humans and Domestic Animals 71  chemical resistant gloves."

User Safety Requirements " Follow manufacturer's instructions for cleaning/ maintaining PPE. If no such instructions for washables exist, use detergent and hot water. Keep and wash PPE separately from other laundry." Precautionary Statements:

Hazards to Humans and Domestic Animals immediately following the PPE requirements User Safety Recommendations " User Safety Recommendations Users should wash hands before eating, drinking, chewing gum, using tobacco, or using the toilet.

Users should remove clothing/ PPE immediately if pesticide gets inside. Then wash thoroughly and put on clean clothing.

Users should remove PPE immediately after handling this product. Wash the outside of gloves before removing. As soon as possible, wash thoroughly and change into clean clothing.@ Precautionary Statements under:

Hazards to Humans and Domestic Animals immediately following Engineering Controls ( Must be placed in a box.)

Environmental Hazards for All Products that have outdoor use sites Note: Products with indoor uses only see below " Environmental Hazards This pesticide is toxic to fish, aquatic invertebrates, and oysters/ shrimp. Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water mark. Do not contaminate water when disposing of equipment washwater or rinsate.

Drift and runoff may be hazardous to aquatic organisms in water adjacent to treated areas.

This product may contaminate water through runoff. This product has a potential for runoff for several days after application. Poorly draining soils and soils with shallow water tables are more prone to produce runoff that contains this product. A level, well maintained vegetative buffer strip between areas to which this product is applied and surface water features such as ponds, steams, and springs will reduce the potential for contamination of water from rainfallrunoff Runoff of this product will be reduced by avoiding applications when rainfall is forecasted to occur within 48 hours. Sound erosion control practices will reduce this product's contribution to surface water contamination." Precautionary Statements immediately following the User Safety Recommendations Environmental Hazards for products that only contain indoor use sites Note to registrant:

Products labeled solely for indoor use except as noted below may omit the Environmental Hazards statements. Such products must have the following statement in the Directions for Use: Precautionary Statements immediately following the User Safety Recommendations 72 " For indoor use only."

Environmental Hazards for Indoor Use Products packaged in containers equal to or greater than 5 gallons or 50 lbs " This pesticide is toxic to fish, aquatic invertebrates, and oysters/ shrimp. Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans, or other waters unless in accordance with the requirements of a National Pollution Discharge Elimination System ( NPDES) permit and the permitting authority has been notified in writing prior to discharge. Do not discharge effluent containing this product to sewer systems without previously notifying the local sewage treatment plant authority. For guidance contact your State Water Board or Regional Office of the EPA." Precautionary Statements Restricted Entry Interval for products with directions for use within the scope of the Worker Protection Standard for Agricultural Pesticides ( WPS) " Do not enter or allow worker entry into treated areas during the restricted entry interval ( REI)

of 12 hours." Directions for Use, Under Agricultural Use Requirements Box Entry Restrictions for all products with indoor use sites AND directions for use outside the scope of the WPS. For products applied as crack and crevice and surface sprays:

" Do not enter or allow other people ( or pets) to enter the treated area until sprays have dried."

For products applied as space sprays or fogs:

" Close doors, windows and shut off all ventilation equipment before application. Leave the treated area. Post signs on entrances stating that the area has been treated with resmethrin and that it is to remain closed for at least 4 hours after application. Do not re enter and do not allow anyone else to re enter the site for 4 hours. Ventilate thoroughly before anyone is allowed to re enter.

 Ventilate thoroughly for 20 minutes for treatment of less than 10,000 cubic feet of space.

 Ventilate thoroughly for 60 minutes for treatment of less than 50,000 cubic feet of space.

 Ventilate thoroughly for 120 minutes for treatment of greater than 50,000 cubic feet of space." If no WPS uses on the product,

place the appropriate statement in the Directions for Use Under General Precautions and Restrictions If the product also contains WPS uses, then create a NonAgricultural Use Requirements box as directed in PR Notice 93 7 and place the appropriate statement inside that box.

Early Entry Personal Protective Equipment for products with directions for use within the scope of the WPS " PPE required for early entry to treated areas that is permitted under the Worker Protection Standard and that involves contact with anything that has been treated, such as plants, soil, or water, is:

 coveralls,

 shoes plus socks  chemical resistant gloves made of any waterproof material." Directions for Use Inside the Agricultural Use Requirements Box General Application " Do not apply this product in a way that will contact workers or other persons, either directly or Place in the Direction for Use 73 Restrictions through drift. Only protected handlers may be in the area during application." directly above the Agricultural Use Box.

Use Specific Application Restrictions Labeling required on all products:

" Do not use in indoor metered spray systems."

" Do not use in automatic misting systems."

Note: Registrants must amend the label to include the maximum allowable application rate and maximum allowable rate per year must be listed as pounds or gallons of formulated products per acre or 1000 ft2, not just as pounds active ingredient per acre or 1000 ft2.

Products labeled for use on Livestock, Farm Animals, and Pets ( Direct Application):

" Do not apply with product containing more than 0.35% ai."

Products labeled for use in Outdoor Sites ( Commercial, Recreational, Domestic Outdoor Sites,

Agricultural Structures, Agricultural Premises, and Agricultural Equipment):

" Do not apply more than 0.25 lb ai per acre."

OR For ready to use products, registrants must amend their labels to specify use rates that result in no more than 0.25 lb ai per acre.

Products labeled for use in Space Applications ( Greenhouses; Indoor Food Handling/ Processing/ Eating Establishments; Commercial Structure Premises and Equipment;

Domestic Structure Premises and Equipment):

" Do not apply more than 0.001 lb ai per 1000 ft2."

OR For ready to use products, registrants must amend their labels to specify use rates that result in no more than 0.001 lb ai per 1000 ft2.

Products labeled for use in Surface Crack and Crevice Application ( Greenhouses; Indoor Food Handling/ Processing/ Eating Establishments; Commercial Structure Premises and Equipment; Directions for Use 74 Domestic Structure Premises and Equipment):

" Do not apply more than 0.242 lb ai per 1000 ft2."

OR For ready to use products, registrants must amend their labels to specify use rates that result in no more than 0.242 lb ai per 1000 ft2 Products labeled for indoor use sites:

" Remove pets, birds, and cover aquariums and turn off air pumps before application.

In food processing operations, homes, or any other location where food is prepared or served,

do not apply this product while food is exposed or being processed. Cover or remove all exposed food, packaging material, and food contact surfaces. Do not apply directly to food,

packaging material, or any food contact surfaces.

Remove or cover dishes, utensils, food processing equipment and food preparation surfaces before use of this product. All food processing surfaces and equipment in the treatment area must be covered or washed with an effective cleaning compound followed by a potable water rinse after use of this product."

For End Use Products Intended for Wide Area Mosquito Abatement Programs Only Restricted Use Pesticide " Restricted Use Pesticide. Due to Acute Fish Toxicity. For retail sale to and use only by certified applicators or persons under their direct supervision and only for those uses covered by the certified applicator's certification. Direct supervision for this product is defined as the certified applicator being physically present during mixing, loading, equipment repair and equipment cleaning. Certified applicators must ensure that all persons involved in these activities under their direct supervision are informed of the precautionary statements." Top front panel PPE Requirements Established by the RED1 " Personal Protective Equipment ( PPE)

Some materials that are chemical resistant to this product are @ ( registrant inserts correct chemical resistant material). If you want more options, follow the instructions for category [ registrant inserts A, B, C, D, E, F, G, or H] on an EPA chemical resistance category selection chart. Immediately following/ below Precautionary Statements:

Hazards to Humans and Domestic Animals 75 All mixers, loaders, applicators, and other handlers must wear:

 long sleeved shirt and long pants,

 socks plus shoes, and  chemical resistant gloves for all handlers except applicators.

See engineering controls for additional requirements."

User Safety Requirements " Follow manufacturer's instructions for cleaning/ maintaining PPE. If no such instructions for washables exist, use detergent and hot water. Keep and wash PPE separately from other laundry." Precautionary Statements:

Hazards to Humans and Domestic Animals immediately following the PPE requirements Engineering Controls Engineering Controls:

" Applicators using ground mechanical application equipment must use an enclosed cab that has a nonporous barrier that totally surrounds the occupants and prevents contact with pesticides outside the cab. Must be provided and have immediately available for use upon exiting the cab chemical resistant gloves."

" Pilots must use an enclosed cockpit. The cockpit must have a nonporous barrier that totally surrounds the occupants and prevents contact with pesticides outside the cab. Pilots must wear the PPE specified in this label for applicators." Precautionary Statements:

Hazards to Humans and Domestic Animals ( Immediately following PPE and User Safety Requirements.)

User Safety Recommendations " User Safety Recommendations Users should wash hands before eating, drinking, chewing gum, using tobacco, or using the toilet.

Users should remove clothing/ PPE immediately if pesticide gets inside. Then wash thoroughly and put on clean clothing.

Users should remove PPE immediately after handling this product. Wash the outside of gloves before removing. As soon as possible, wash thoroughly and change into clean clothing.@ Precautionary Statements under:

Hazards to Humans and Domestic Animals immediately following Engineering Controls ( Must be placed in a box.) 76 Environmental Hazards " This pesticide is toxic to aquatic organisms, including fish, crustaceans, and oysters. Runoff from treated areas or deposition of spray droplets into a body of water may be hazardous to fish, crustaceans, and oysters."

" Do not apply when bees are visiting the treatment area, except when applications are made to prevent or control a threat to public and/ or animal health determined by a state, tribal, or local health or vector control agency on the basis of documented evidence of disease causing agents in vector mosquitoes or the occurrence of mosquito borne disease in animal or human populations, or if specifically approved by the state or tribe during a natural disaster recovery effort."

" Before making the first application in a season, it is advisable to consult with the state or tribal agency with primary responsibility for pesticide regulation to determine if other regulatory requirements exist."

" Do not apply over bodies of water ( lakes, rivers, permanent streams, natural ponds,

commercial fish ponds, swamps, marshes or estuaries), except when necessary to target areas where adult mosquitoes are present, and weather conditions will facilitate movement of applied material away from the water in order to minimize incidental deposition into the water body.

Do not contaminate bodies of water when disposing of equipment rinsate or washwaters." Precautionary Statements immediately following the User Safety Recommendations Application Restrictions " Do not apply more than 0.007 lb ai/ acre per application."

" Do not apply more than 0.2 lb ai/ acre per year in any treated area. More frequent treatments may be made to prevent or control a threat to public and/ or animal health determined by a state,

tribal, or local health or vector control agency on the basis of documented evidence of disease causing agents in vector mosquitoes or the occurrence of mosquito borne disease in animal or human populations, or if specifically approved by the state or tribe during a natural disaster recovery effort."

" Products must comply with EPA PR Notice 2005 1." Directions for Use Spray Drift Label Language for ALL Products Intended for SPRAY DRIFT MANAGEMENT Directions for Use under General Precautions and Restrictions 77 ULV Mosquito Abatement Programs Only " A variety of factors including weather conditions ( e. g., wind direction, wind speed,

temperature, relative humidity) and method of application ( e. g., ground, aerial, airblast,

chemigation) can influence pesticide drift. The applicator must evaluate all factors and make appropriate adjustments when applying this product."

WIND SPEED:

" Do not apply when wind speed is 0 mph."

DROPLET SIZE:

" Ground based application:

Spray equipment must be adjusted so that the volume median diameter is less than microns ( Dv 0.5 < 8 30 um) and that 90% of the spray is contained in droplets smaller than microns ( Dv 0.9 < 50 um). Directions from the equipment manufacturer or vendor, pesticide registrant or a test facility using a laxer based measurement instrument must be used to adjust equipment to produce acceptable droplet size spectra. Application equipment must be tested at least annually to confirm that pressure at the nozzle and nozzle flow rate( s) are properly calibrated."

" Aerial Application:

Spray equipment must be adjusted so that the volume median diameter produced is less than microns ( Dv 0.5 < 60 um) and that 90% of the spray is contained in droplets smaller than microns ( Dv 0.9 < 80 um). The effects of flight speed, and for non rotary nozzles, nozzle angle on the droplet size spectrum must be considered. Directions from the equipment manufacturer or vendor, pesticide registrant or a test facility using a wind tunnel and laser based measurement instrument must be used to adjust equipment to produce acceptable droplet size spectra. EQUIPMENT CALIBRATION:

Application equipment must be tested at least annually to confirm that pressure at the nozzle and nozzle flow rate( s) are properly calibrated."

RELEASE HEIGHT:

Fixed wing:

" Apply using a nozzle height of no less than 100 feet above the ground or canopy." 78 Rotary wing:

" Apply using a nozzle height of no less than 75 feet above the ground or canopy."

BOOM LENGTH:

" The boom length must not exceed 75% of the wingspan or 90% of the rotor blade diameter."

End Use Products Intended for Residential Use Application Restrictions " Do not apply this product in a way that will contact any person or pet, either directly or through drift. Keep people and pets out of the area during application." Directions for Use under General Precautions and Restrictions Entry Restrictions For products applied as crack and crevice and surface sprays:

" Do not enter or allow other people ( or pets) to enter the treated area until sprays have dried."

For products applied as space sprays or fogs:

" Close doors, windows and shut off all ventilation equipment before application. Leave treated area closed for at least 2 hours after application. Do not remain in treated area( s). Ventilate thoroughly for 20 minutes with fresh air before re occupying treated area( s)." Directions for use under General Precautions and Restrictions Environmental Hazards . For products that have outdoor uses:

" This product is extremely toxic to fish, aquatic invertebrates, and oysters/ shrimp. Do not apply directly to or near water. Drift and run off may be hazardous to fish in water adjacent to treated areas. Do not contaminate water when disposing of equipment, washwater, or rinsate.

See Directions for Use for additional precautions and requirements." Precautionary Statements immediately following the User Safety Recommendations Use Specific Application Restrictions Labeling required on all products applied as sprays:

" Do not use in indoor metered spray systems."

" Do not use in automatic misting systems."

APPLICATION RATE RESTRICTIONS: Directions for Use 79 Products containing greater than 0.35% ai must not be labeled for use on pets.

Note: Registrants must amend the label to reflect the below maximum allowable application rate per year. The rate must be listed as pounds or gallons of formulated product per acre or 1000 ft2, not just as pounds active ingredient per acre or 1000 ft2. For ready to use products,

registrants must amend their labels to specify use rates that will result in the below maximum application rates.

Products labeled for use in Outdoor Sites ( Backyard, patios, and ornamentals):

Maximum application rate 0.25 lb ai per acre.

Products labeled for Space Application ( domestic dwellings):

Maximum application rate 0.001 lb ai per 1000 ft2.

" Do not use more than 3 times a year."

Products labeled for Surface Crack and Crevice Application ( domestic dwellings):

Maximum application rate 0.242 lb ai per 1000 ft2.

OTHER RESTRICTIONS:

Products labeled for use in indoor use sites:

" Remove pets, birds, and cover aquariums and turn off air pumps before application."

" In homes or any other location where food is prepared or served, do not apply this product while food is exposed or being processed. Cover or remove all exposed food and food contact surfaces. Do not apply directly to food, packaging material, or any food contact surfaces."

" Remove or cover dishes, utensils, food processing equipment and food preparation surfaces before use of this product. All food processing surfaces and equipment in the treatment area should be covered or washed with an effective cleaning compound followed by a potable water rinse after use of this product."

Products labeled for use in outdoor use sites except for Ready to Use Formulations: 80 " Do not apply directly to or near water, storm drains, or drainage ditches. Do not apply when windy. To prevent product run off, do not over water the treated area( s) or apply when heavy rain is expected. Rinse application equipment over lawn or garden area only."

Ready to use products labeled for outdoor use sites:

" Do not apply directly to or near water, storm drains, or drainage ditches. Do not apply when windy. To prevent product run off, do not over water the treated area( s) or apply when heavy rain is expected."

1 PPE that is established on the basis of Acute Toxicity of the end use product must be compared to the active ingredient PPE in this document. The more protective PPE must be placed in the product labeling. For guidance on which PPE is considered more protective, see PR Notice 93 7. 81 Appendix A Use Patterns Subject for Reregistration of Resmethrin Site Form Code Max. App Rate/ App Unit ( ai) Use Pattern/ Limitations DIRECT APPLICATION TO LIVESTOCK, FARM ANIMALS, AND PETS RTU 0.35% N/ A OUTDOOR USE SITES ( COMMERCIAL, RECREATIONAL, DOMESTIC OUTDOOR SITES, AGRICULTURAL STRUCTURES, AGRICULTURAL PREMISES, AND AGRICULTURAL EQUIPMENT) EC, PRL, RTU, SC/ L 0.25 lb/ acre For ready to use products, registrants must amend their labels to specify use rates that result in no more than 0.25 lb ai per acre.

SPACE APPLICATIONS ( GREENHOUSES; INDOOR FOOD HANDLING/ PROCESSING/ EATING ESTABLISHMENTS; COMMERCIAL STRUCTURE PREMISES AND EQUIPMENT; DOMESTIC STRUCTURE PREMISES AND EQUIPMENT) EC, PRL, RTU 0.001 lb/ 1000ft2 For ready to use products, registrants must amend their labels to specify use rates that result in no more than 0.001 lb ai per 1000ft2.

SURFACE CRACK AND CREVICE APPLICATION ( GREENHOUSES; INDOOR FOOD HANDLING/ PROCESSING/ EATING ESTABLISHMENTS; COMMERCIAL STRUCTURE PREMISES AND EQUIPMENT; DOMESTIC STRUCTURE PREMISES AND EQUIPMENT) EC, PRL, RTU 0.242 lb/ 1000ft2 For ready to use products, registrants must amend their labels to specify use rates that result in no more than 0.242 lb ai per 1000ft2. 82 Site Form Code Max. App Rate/ App Unit ( ai) Use Pattern/ Limitations END USE PRODUCTS INTENDED FOR WIDE AREA MOSQUITO ABATEMENT PROGRAMS EC, EC* RTU 0.007 lb/ acre " Restricted Use Pesticide. Due to Acute Fish Toxicity. For retail sale to and use only by certified applicators or persons under their direct supervision and only for those uses covered by the certified applicator's certification. Direct supervision for this product is defined as the certified applicator being physically present during mixing, loading, equipment repair and equipment cleaning. Certified applicators must ensure that all persons involved in these activities under their direct supervision are informed of the precautionary statements."

" Do not apply more than 0.007 lb ai/ acre per application."

" Do not apply more than 0.2 lb ai/ acre per year in any treated area. More frequent treatments may be made to prevent or control a threat to public and/ or animal health determined by a state, tribal, or local health or vector control agency on the basis of documented evidence of disease causing agents in vector mosquitoes or the occurrence of mosquito borne disease in animal or human populations, or if specifically approved by the state or tribe during a natural disaster recovery effort."

" Products must comply with EPA PR Notice 2005 1." 83 Appendix B GUIDE TO APPENDIX B Appendix B contains listings of data requirements which support the reregistration for active ingredients within the case 2510 covered by this Reregistration Eligibility Decision Document. It contains generic data requirements that apply to 2510 in all products, including data requirements for which a " typical formulation" is the test substance.

The data table is organized in the following format:

1. Data Requirement ( Column 1). The data requirements are listed in the order in which they appear in 40 CFR Part 158. The reference numbers accompanying each test refer to the test protocols set in the Pesticide Assessment Guidelines, which are available from the National Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 ( 703) 487 4650.

2. Use Pattern ( Column 2). This column indicates the use patterns for which the data requirements apply. The following letter designations are used for the given use patterns:

A Terrestrial food B Terrestrial feed C Terrestrial non food D Aquatic food E Aquatic non food outdoor F Aquatic non food industrial G Aquatic non food residential H Greenhouse food I Greenhouse non food J Forestry K Residential L Indoor food M Indoor non food N Indoor medical O Indoor residential 3. Bibliographic citation ( Column 3). If the Agency has acceptable data in its files, this column lists the identifying number of each study. This normally is the Master Record Identification ( MRID) number, but may be a " GS" number if no MRID number has been assigned. Refer to the Bibliography appendix for a complete citation of the study. 84 APPENDIX B Data Supporting Guideline Requirements for the Reregistration of Resmethrin REQUIREMENT USE PATTERN CITATION( S)

PRODUCT CHEMISTRY New Guideline Number Old Guideline Number 830.1550 61 1 Product Identity and Composition All 42085701,43184901 830.1600 830.1620 830.1650 61 2A Start. Mat. & Mnfg. Process All 42085701,43184901,43392201,43090801 830.1670 61 2B Formation of Impurities All 42085701,43184901,4309081 830.1700 62 1 Preliminary Analysis All 42085702 830.1750 62 2 Certification of limits All 830.1800 62 3 Analytical Method All 42085702, 43184901,43090802 830.6302 63 2 Color All 43241602, 42085703, 43259801,43184901,43435701, 85 Data Supporting Guideline Requirements for the Reregistration of Resmethrin REQUIREMENT USE PATTERN CITATION( S) 43330101,43090803 830.6303 63 3 Physical State All 43241602, 42085703, 43259801,

43184901,43435701, 43330101, 43090803 830.6304 63 4 Odor All 43241602, 42085703, 43259801, 43184901,

43435701, 43330101,43090803 830.6314 63 14 Oxidation/ reduction: chemical incompatability 43241602, 42085703, 43259801, 43184901,

43435701, 43330101, 43090803 830.6315 63 15 Flammability 43241602, 43259801, 43184901, 43435701,

43330101, 43090803 830.6316 63 16 Explodability 43241602, 42085703, 43259801, 43184901,

43435701, 43330101, 43090803 830.6317 63 17 Storage Stability 42085703,43184901,43993701,43993601,43090 803, 40766101 830.6319 63 19 Miscibility 43241602, 43259801,43184901, 43435701,

43330101, 43090803 830.6320 63 20 Corrosion Characteristics 42085703, 43259801, 43184901, 43993701,

43993601, 43090803 830.7100 63 18 Viscosity 43241602,43259801, 43184901, 43435701,

43330101, 43090803 830.7200 63 5 Melting Point All 42085703 830.7300 63 7 Density All 43241602,42085703,43259801, 86 Data Supporting Guideline Requirements for the Reregistration of Resmethrin REQUIREMENT USE PATTERN CITATION( S) 43184901,43435701, 43330101 830.7840 830.7860 63 8 Solubility All 42085703 830.7950 63 9 Vapor Pressure All 42085703 830.7370 63 10 Dissociation Constant All 42085703,42143701 830.7550 63 11 Octanol/ Water Partition Coefficient All 830.7000 63 12 pH All 43241602, 42085703, 43184901, 43435701,

43330101, 43090803 830.6313 63 13 Stability All 42085703 ECOLOGICAL EFFECTS 850.2100 71 1A Avian Acute Oral Toxicity  Quail ABCIKM 850.2200 71 2A Avian Dietary Toxicity  Quail ABCIKM 850.2200 71 2B Avian Dietary Toxicity  Duck ABCK 850.1075 72 1A Fish Acute Toxicity Bluegill ABCK 850.1075 72 1C Fish Acute Toxicity Rainbow Trout ABCIKM 850.1010 72 2 Invertebrate Toxicity ABCIKM None 72 3A Estuarine/ Marine Toxicity  Fish ABCK 87 Data Supporting Guideline Requirements for the Reregistration of Resmethrin REQUIREMENT USE PATTERN CITATION( S)

None 72 3C Estuarine/ Marine Toxicity  Shrimp ABCK None 72 4B Estuarine/ Marine Invertebrate Life Cycle ABCK 122 2 Aquatic plant growth 850.4225 123 1A Seed germ/ seedling emergence ABCK 850.4250 123 1B Vegetative vigor ABCK 850.4400 123 2B Aquatic Plant Growth, Tier 2 ABCK TOXICOLOGY 870.1100 81 1 Acute Oral Toxicity Rat ABCIKM 42076201 870.1200 81 2 Acute Dermal Toxicity Rabbit ABCIKM 42076202 870.1300 81 3 Acute Inhalation Toxicity Rat ABCIKM 42153701 870.2400 81 4 Primary Eye Irritation Rabbit ABCIKM 42076203 870.2500 81 5 Primary Skin Irritation ABCIKM 42076204 870.2600 81 6 Dermal Sensitization ABCIKM 42153702 870.3100 82 1A 90 Day Feeding  Rodent ABCIKM 43338601, 43838101 870.3200 82 2 21 Day Dermal  Rabbit/ Rat ABCHIK 42066901 870.3465 82 4 90 Day Inhalation 00158476 88 Data Supporting Guideline Requirements for the Reregistration of Resmethrin REQUIREMENT USE PATTERN CITATION( S)

870.4100 83 1A Chronic Feeding Toxicity  Rodent ABCIKM 00157961,43601601 870.4100 83 1B Chronic Feeding Toxicity  Non

Rodent ABCIKM 43062601 870.4200 83 2A Oncogenicity  Rat ABCIKM 0083319 870.4200 83 2B Oncogenicity  Mouse ABCIKM 43052101 870.4300 83 5 Chronic/ Oncogenicity 00041402,00085870,00108628,43271701,

43601601,00041402,00108828 870.3700 83 3A Developmental Toxicity  Rat ABCIKM 00028453,

870.3700 83 3B Developmental Toxicity Non Rodent 46582601,00029002 870.3800 83 4A 2 Generation Reproduction  Rat ABCIKM 43189101,

870.3800 83 4B Reproduction 00081276, 124308 870.5140 84 2A Gene Mutation ( Ames Test) ABCIKM 870.5265 41068010 870.5375 84 2B Structural Chromosomal Aberration ABCIKM 41068011,

870.5550 84 2 870.6200 82 7A Acute Neurotox. Screening Battery ( rat) 00025552,00025553,00025554 870.6200 82 7B 90 Day Neuro. Screening Battery ( rat) 89 Data Supporting Guideline Requirements for the Reregistration of Resmethrin REQUIREMENT USE PATTERN CITATION( S)

None 84 4 Other Genotoxic Effects ABCIKM 870.7485 85 1 General Metabolism ABCIKM 42133801,42136101 870.7600 85 3 Dermal Penetration 46382501 OCCUPATIONAL/ RESIDENTIAL EXPOSURE 875.2100 132 1A Foliar Residue Dissipation ABCIK ENVIRONMENTAL FATE 835.2120 161 1 Hydrolysis ABCIK 470077046 835.2240 161 2 Photodegradation  Water ABCK 00153059,

835.2410 161 3 Photodegradation  Soil ABC 161 4 835.4100 162 1 Aerobic Soil Metabolism ABCIK 41913601, 41913601 162 2 Anaerobic soil Metabolism 835.4400 162 3 Anaerobic Aquatic Metabolism ABC 42298401 162 4 Aerobic Aquatic Metabolism 42043003 835.1240 163 1 Leaching/ Adsorption/ Desorption ABCIK 163 2 163 3 90 Data Supporting Guideline Requirements for the Reregistration of Resmethrin REQUIREMENT USE PATTERN CITATION( S)

835.6100 164 1 Terrestrial Field Dissipation ABCK 164 2 164 3 165 4 165 5 166 1 166 2 201 1 202 1 RESIDUE CHEMISTRY 860.1300 171 4A Nature of Residue  Plants ABK 860.1300 171 4B Nature of Residue  Livestock AB 860.1340 171 4C Residue Analytical Method

Plants/ Animals ABK 860.1340 171 4D Residue Analytical Method Animal 860.1360 171 4M Multiresidue Method 860.1380 171 4E Storage Stability ABK 91 Data Supporting Guideline Requirements for the Reregistration of Resmethrin REQUIREMENT USE PATTERN CITATION( S)

860.1480 171 4J Magnitude of Residues

Meat/ Milk/ Poultry / Egg ABK 860.1500 171 4K Crop Field Trials ( Potatoes) ABK OTHER 860.1850 165 1 Confined Accumulation in Rotational ABC 810.1900 165 2 Field Accumulation in Rotational ABC 840.1200 202 1 Drift field evaluation a TGAI is a solid at room temperature.

b Data used to support carbendazim.

c Additional data is needed. The registrant has proposed two HPLC/ UV methods for enforcing tolerances of thiophenate methyl in plant ( Method BR 93 28) and animal ( Method KP 100 04) commodities. Prior to validation by the Agency, the method should be radiovalidated using samples from animal and plant metabolism studies.

d Multiresidue method ( MRM) recovery data are required for thiophenate methyl and MBC through FDA protocols A through G.

e Data are required depicting the frozen storage stability of thiophenate methyl and MBC in representative raw and processed plant commodities held in frozen storage for up to five years.

f Additional field trial in CA is required ( see residue chemistry chapter).

g Data are required depicting residues of thiophenate methyl and MBC in/ on green onions harvested at the minimum interval following a broadcast application at planting of thiophenate methyl ( WP/ WDG/ FIC) at 1.4 lb ai/ A. A minimum of three field trials should be conducted; two in Region 10 and one in Region 6.

h If the registrant intends to support a use on dry peas and lentils, additional residue data for dried peas need to be submitted. 92 i To support this group crop tolerance, the registrant has submitted representative field trials for the following representative crops:

cucumbers, melon, pumpkin and squash.

j The available residue data are inadequate because of deficiencies in analytical method.

N/ A not applicable. 93 Appendix C TECHNICAL SUPPORT DOCUMENTS Additional documentation in support of this RED is maintained in the OPP docket, located in Room S 4400, One Potomac Yard ( South Building), 1777 S. Crystal Drive, Arlington, VA. It is open Monday through Friday, excluding legal holidays, from 8: 30 am to 4 pm.

The preliminary risk assessments for permethrin are available in the public docket and in e dockets under docket number OPP 2004 0385. This contains risk assessments and related documents as of August 2005. During the comment period, the registrant submitted additional data for permethrin. EPA reviewed these data and incorporated them into the revised risk assessments for permethrin. These revised risk assessments form the basis of the regulatory decision described in this RED. These risk assessment and related documents are available under docket number OPP 2004 0385.

Technical support documents for the Permethrin RED include the following:

Human Health Risk Assessment Documents; 1. Resmethrin HED Revised Risk Assessment for Reregistration Eligibility Document ( RED) PC Code 097801; DP Barcode 326088, dated February 23, 2006. 2. Resmethrin: Response to Public Comments on the HED Risk Assessment for Resmethrin RED Chapter; PC Code 097801; DP Barcode 291445, dated February 23, 2006. 3. Resmethrin and Bioresmethrin. Revised Product and Residue Chemistry Considerations for Reregistration Eligibility Decisions, dated February 16, 2006. 4. Revised Occupational and Residential Exposure Assessment and Recommendations for the Reregistration Eligibility Decision ( RED) for Resmethrin, dated February 23, 2006. 5. Resmethrin Revised Chronic and Cancer Dietary Exposure Assessments for the Reregistration Eligibility Decision PC Code 097801 DP Barcode 326090, dated February 22, 2006.

Environmental Fate and Effects Documents; 1. EFED RED Chapter for Resmethrin, Revision Phase 3, dated March 8, 2006. 2. Response to Comments of the Phase 3 Period for the Revised Draft EFED RED Chapter for Resmethrin, dated March 8, 2006. 3. Revised Tier II Estimated Drinking Water Concentrations for Resmethrin, dated February 13, 2006. 4. Preliminary Environmental Fate and Effects Division Risk Assessment Chapter for the Reregistration Eligibility Decision ( RED) Document for: Resmethrin, dated March 8, 2006. 94 5. Appendicies to the EFED Risk Assessment Chapter for the RED Document for Resmethrin, dated March 8, 2006 95 Appendix D Bibilography MRID Citation Reference Human Health Studies 43338601 Kangas, L. ( 1989) A 4 Week Dietary Toxicity Study of SBP 1382 in the Albino Mouse: Lab Project Number: 83753. Unpublished study prepared by Bio Research Lab. Ltd. 241 p. 42066901 Meyers, L. ( 1991) 21 Day Percutaneous Toxicity Study of Resmethrin in Rabbits: Lab Project Number: HWA 2623 100: RBT 90 217. Un published study prepared by Hazleton Washington, Inc. 312 p. 00025552 Schwartz, C. S.; Becci, P. J.; Parent, R. A.; et al. ( 1979) Report: Evaluation of the Neurotoxic Effects of SBP 1382 in Albino Rats Phase 1: FDRL Study # 6067. Includes method dated Jul 2, 1979. ( Unpublished study including letter dated Nov 28, 1979 from R. W. Fogleman to B. B. Brown and Maarten devries, received Dec 19, 1979 under 432 487; prepared by Food and Drug Research Laboratories, Inc., submitted by Penick Corp., Lyndhurst, N. J.; CDL: 241501 B) 00025553 Cox, G. E.; Becci, P. J.; Parent, R. A.; et al. ( 1979) Supplementary Report for Evaluation of the Neurotoxic Effects of SBP 1382 in Albino Rats Phase I: FDRL Study # 6362. ( Unpublished study in cluding letter dated Nov 28, 1979 from R. W. Fogleman to B. B. Brown and Maarten L. derVies, prepared by Food and Drug Research Laboratories, Inc., received Dec 19, 1979 under 432 487; submit ted by Penick Corp., Lyndhurst, N. J.; CDL: 241502 B) 00025554 Schwartz, C. S.; Becci, P. J.; Parent, R. A.; et al. ( 1979) Report: Evaluation of the Neurotoxic Effects of SBP 1382 in Albino Rats: Phase II: FDRL Study # 6068. ( Unpublished study including let ter dated Nov 28, 1979 from R. W. Fogleman to B. B. Brown and Maarten L. deVries, received Dec 19, 1979 under 432 487; pre pared by Food and Drug Research Laboratories, Inc., submitted by Penick Corp., Lyndhurst, N. J.; CDL: 241503 B) 00157961 Gephart, L.; Johnson, W.; Becci, P.; et al. ( 1980) 180 Day Sub chronic Oral Dosing Study with Resmethrin ( SBP 1382) in Beagle Dogs: Laboratory No. 6289. Unpublished study prepared by Food and Drug Research Laboratories, Inc. 553 p. 43062601 Dalgard, D. ( 1993) 52 Week oral Toxicity Study of SBP 1382 ( Resmethrin) Technical in Dogs: Final Report: Lab Project Number: HWA 2623 105: RBT 92 100. Unpublished study prepared by Hazleton Washington, Inc. 375 p. 42133801 Ruzo, L.; Krautter, G.; Marsh, J.; et al. ( 1991) Absorption, Dist ribution, Elimination and Metabolism of Carbon 14 alcohol| d trans Resmethrin in the Rat: Lab Project Number: 411E/ 239W. Un published study prepared by PTRL West, Inc. and PTRLEast Inc. 370 p. 42136101 Ruzo, L.; Krautter, G.; Jiang, J. ( 1991) Absorption, Distribution, Elimination, and Metabolism of ?? Carbon 14| acid| d trans Resme thrin in the Rat: Lab Project Number: 410E/ 238W. Unpublished study prepared by Pharmacology and Toxicology Research Lab West and East, Incs. 371 p. 42076201 Catez, D. ( 1991) Acute Oral Toxicity Study of Bioresmethrin ( Techn ical) in the Rat: Lab Project Number: 90/ 2172/ TX. Unpublished Study prepared by Roussel Uclaf. 93 p. 42076202 Catez, D. ( 1991) Acute Dermal toxicity study of Bioresmethrin ( technical) in the rabbit. Lab Project No. 90/ 2177/ TX. Unpublished study prepared by Roussel Uclaf. 42p. 42153701 Hardy, C., Jackson, G., Suttie, A. et. al. ( 1989) Acute inhalation toxicity study of Bioresmethrin ( technical) in the rat. 4 hour exposure. Lab Project No. 801/ 189712 RBT 89 137. Unpublished study prepared by Huntington Research Center, Ltd. 54p.

42076203 Catez, D. ( 1991) Primary eye irritation toxicity study of Bioresmethrin ( technical) in the rabbit. Lab Project No. 90/ 2178/ TX. Unpublished study prepared by Roussel Uclaf. 96 MRID Citation Reference 33p. 42076204 Catez, D. ( 1991) Primary dermal irritation toxicity study of Bioresmethrin ( technical) in the rabbit. Lab Project No. 90/ 2170/ TX. Unpublished study prepared by Roussel Uclaf. 33p.

42153702 Khun, J.. ( 1990) Dermal sensitization study of Bioresmethrin ( technical) in the guinea pig. Lab Project No. 6674 89 Unpublished study prepared by Stillmeadow, Inc. 17p. 43338601 Kangas, L. ( 1989) A 4 Week Dietary Toxicity Study of SBP 1382 in the Albino Mouse: Lab Project Number: 83753. Unpublished study prepared by Bio Research Lab. Ltd. 241 p. 46382501 Selmin, S. ( 2004) A single dose, open label study to investigate the absorption and excretion of orally administered or dermally applied ( C14) labeled pyrethrins I ( PI) to heathy male volunteers. Charles River Labs ( CRL), Bayer AG, Pharma Bio Research Clinics. SEL study no. SEL 0204, CRL study no. BTAZ 103, pharma Bio Research Code PBR 013911. 10/ 08/ 04. MRID 46382501. unpublished. 00157961 Gephart, L.; Johnson, W.; Becci, P.; et al. ( 1980) 180 Day Subchronic Oral Dosing Study with Resmethrin ( SBP 1382) in Beagle Dogs: Laboratory No. 6289. Unpublished study prepared by Food and Drug Research Laboratories, Inc. 553 p. 43838101 Serabian, M. ( 1993) Subchronic Toxicity Study in Rats with SBP 1382 ( Resmethrin) Technical: Final Report: Lab Project Number: HWA 2623 101: RBT 91 125. Unpublished study prepared by Hazleton Washington, Inc. 1221 p. 42066901 Meyers, L. ( 1991) 21 Day Percutaneous Toxicity Study of Resmethrin in Rabbits: Lab Project Number: HWA 2623 100: RBT 90 217. Unpublished study prepared by Hazleton Washington, Inc. 312 p. 00158476 Coombs, D.; Hardy, C.; Clark, G.; et al. ( 1985) 90 Day Inhalation Toxicity Study in the Rat: Resmethrin: ( SBP  1382 Technical): SBP 6/ 84997. Unpublished study prepared by Huntingdon Research Centre. 333 p. 00041402 Knickerbocker, M.; Becci, P. J.; Cox, G. E.; et al. ( 1980) Final Report: A Lifetime Evaluation of the Dietary Administration of SBP 1382 to Wistar Albino Rats: Laboratory No. 5271. ( Unpublished study received Jul 8, 1980 under 432 487; prepared by Food and Drug Research Laboratories, Inc. and Cornell Univ., submitted by Penick Corp., Lyndhurst, N. J.; CDL: 242782 A; 242786; 242785; 242783; 242784) 00085870 Thompson, S. W. ( 1981) A Lifetime Evaluation of the Dietary Administration of SBP 1382 to Wistar Albino Rats: Laboratory No. 5271. ( Unpublished study, including letters dated Mar 26, 1980 from E. F. Mace to Maarten De Vries, May 13, 1981 from F. D. R. Gee to Maarten L. De Vries, Aug 17, 1981 from M. A. Gallo to Emily F. Hedal and Nov 9, 1981 from M. L. De Vries to Franklin D. R. Gee, received Nov 10, 1981 under 432 487; prepared by Food and Drug Research Laboratories, Inc., submitted by Penick Corp., Lyndhurst, N. J.; CDL: 246214 A) 00108828 Becci, P.; Hess, F.; Thompson, S. ( 1982) A Lifetime Evaluation of the Dietary Administration of SBP 1382 to Wistar Albino Rats: FDRL Study No. 5271. ( Unpublished study received May 27, 1982 under 432 487; prepared by Food and Drug Research Laboratories, Inc., submitted by Penick Corp., Lyndhurst, NJ; CDL: 247579 A) 43271701 Vandernerghe, J. ( 1990) Life Span Data and Historical Data in Carcinogenicity Testing in Wistar Rats Crl: ( WI) BR: Supplemental. Unpublished study prepared by Janssen Research Foundation. 210 p. 43062601 Dalgard, D. ( 1993) 52 Week oral Toxicity Study of SBP 1382 ( Resmethrin) Technical in Dogs: Final Report: Lab Project Number: HWA 2623 105: RBT 92 100. Unpublished study prepared by Hazleton Washington, Inc. 375 p. 43601601 Trutter, J. ( 1994) Combined Chronic Toxicity and Oncogenicity Study in Rats with SBP 1382 ( Resmethrin) Technical: Final Report: Lab Project Number: HWA 2623 104. Unpublished study prepared by Hazleton Washington, Inc. 2518 p. 00083319 Knickerbocker, M.; Cox, G. E.; Parent, R. A. ( 1979) Evaluation of Dietary 97 MRID Citation Reference Administration of SBP 1382 in CD 1 Outbred Albino Mice over an 85 Week Period: Laboratory No. 5270. Final rept. ( Un published study received Aug 14, 1979 under 432 487; prepared by Food and Drug Research Laboratories, Inc., submitted by Penick Corp., Lynhurst, N. J.; CDL: 239853 A; 238954; 238955; 238956; 238957) 43052101 Kangas, L. ( 1992) A Dietary Oncogenicity Study of SBP 1382 in the Albino Mouse: Lab Project Number: RBT 92 111: 83754: F2216. Unpublished study prepared by Bioresearch Labs., Ltd. 2173 p. 00028453 Machi, R. A.; Kam, C.; Gallo, M. A.; et al. ( 1979) Teratologic Evaluation of SBP 1382 Technical in the Albino Rat: Snell Project # 2054 066. ( Unpublished study received Jan 23, 1980 under 432 487; prepared by Booz, Allen & Hamilton, Inc., submitted by Penick Corp., Lyndhurst, N. J.; CDL: 241765 A; 241766; 241768; 241769; 241770) 00029002 Becci, P. J.; Knickerbocker, M.; Parent, R. A. ( 1979) Teratologic Evaluation of SBP 1382 Technical in Albino Rabbits: FDRL Laboratory No. 6288. ( Unpublished study including letter dated Jan 14, 1980 from R. W. Fogleman to Maarten L. deVries, received Jan 23, 1980 under 432 487; prepared by Food and Drug Research Laboratories, Inc., submitted by Penick Corp., Lyndhurst, N. J.; CDL: 241800 A) 00081276 Schwartz, C. S.; Gephart, L.; Becci, P. J.; et al. ( 1979) The Evaluation of the Effects of SBP 1382 following Dietary Administration through Three Generations in Sprague Dawley Rats: Labora tory No. 5739. ( Unpublished study received Aug 30, 1979 under 432 487; prepared by Food and Drug Research Laboratories, Inc., submitted by Penick Corp., Lyndhurst, N. J.; CDL: 240984 A) 00124308 Norwood, T. ( 1981) A Statistical Analysis of the Effects of Dietary SBP 1382 on Three Generations of Sprague Dawley Rats. ( Unpublished study received Aug 3, 1981 under 432 487; submitted by Penick Corp., Lyndhurst, NJ; CDL: 245845 A; 245846; 245847; 245848) 43189101 Hoberman, A. ( 1994) Reproductive Effects of SBP 1382 ( Resmethrin) Technical Administered Orally via the Diet to Crl: CD BR VAF/ Plus Rats for Two Generations with Two Litters per Generation: Lab Project Number: 718 004: RBT 92 102. Unpublished study prepared by Argus Research Laboratories. 1533 p. 41068010 Lawlor, T.; Wagner, V. ( 1987) Salmonella/ Mammalian Microsome Plate Incorporation Mutagenicity Assay ( Ames Test) with a Confirmatory Assay: Laboratory ID T5747.501014. Unpublished study prepared by Microbiological Associates, Inc. 62 p. 41068011 Putman, D. ( 1988) Chromosome Aberrations in Chinese Hamster Ovary ( CHO) Cells: Resmethrin NDRC 104: Laboratory ID T5747.337003. Unpublished study prepared by Microbiological Associates, Inc. 30 p. 41068012 Curren, R. ( 1988) Unscheduled DNA Synthesis in Rat Primary Hepatocytes: Resemethrin NDRC 104: Laboratory ID T5747.380. Unpublished study prepared by Microbiological Associates, Inc. 27 p. 42133801 Ruzo, L.; Krautter, G.; Marsh, J.; et al. ( 1991) Absorption, Distribution, Elimination and Metabolism of Carbon 14 alcohol| d trans Resmethrin in the Rat: Lab Project Number: 411E/ 239W. Unpublished study prepared by PTRL West, Inc. and PTRL East, Inc. 370 p. 42136101 Ruzo, L.; Krautter, G.; Jiang, J. ( 1991) Absorption, Distribution, Elimination and Metabolism of C14 acid d trans resmethrin in the rat. Project No. 410E/ 238W. Unpublished study prepared by PTRL West and PTRL East, Inc.. 371 p. Chemistry Studies 40766101 Brill, J. ( 1988) Storage Stability Study: Tetralate 16.67 7.065. Unpublished study prepared by Fairfield American Corp. 4 p. 42085701 Giudicelli, J. ( 1991) Product Identity and Composition of Resmethrin Technical: Lab Project Number: STE 256 A 08 1/ 61. Unpublished study prepared by Roussel Uclaf. 28 p. 42085702 Giudicelli, J. ( 1991) Analysis and Certification of Resmethrin Technical: Lab Project Number: STE 256 A 08 1/ 62. Unpublished study prepared by Roussel Uclaf. 41 p. 42085703 Giudicelli, J. ( 1991) Physical and Chemical Properties of Resmethrin Technical: Lab 98 MRID Citation Reference Project Number: STE 256 A 08 1/ 63. Unpublished study prepared by Roussel Uclaf. 9 p. 43090801 Johnston, S. ( 1994) Product Identity and Composition of Tetralate Butacide ( 15 7.5 15) W B Concentrate. Unpublished study prepared by Roussel Uclaf Corp. 25 p. 43090802 Johnston, S. ( 1994) Analysis and Certification of Product Ingredients of Tetralate Butacide ( 15 7.5 15) W B Concentrate. Unpublished study prepared by Roussel Uclaf Corp. 19 p. 43090803 Johnson, D. ( 1993) Tetralate Butacide 15 7.5 15 W B Concentrate: Determination of Product Chemistry: Lab Project Number: 152. Unpublished study prepared by Roussel Uclaf Corp. 15 p. 43241602 Vera, I. ( 1994) SBP 1382 Insecticide Concentrate 40 % Formula I Determination of Product Chemistry: Lab Project Number: 184. Unpublished study prepared by Roussel Uclaf Corp. 15 p. 43184901 Johnson, D.; Puchalski, R. ( 1991) Product Chemistry: SBP 1382 Insecticide Concentrate 12% Formula I. Unpublished study prepared by Roussel Bio Corp. 36 p. 43259801 Girard, M. ( 1994) SBP 1382 Concentrate 15% F1: Determination of Product Chemistry: Lab Project Number: 179. Unpublished study prepared by Roussel Uclaf Corp. 14 p. 43330101 Vera, I. ( 1994) SBP 1382/ Bioallethrin 10 7.5 FI: Determination of Product Chemistry: Lab Project Number: 202. Unpublished study prepared by Roussel Uclaf Corp. 16 p. 43392201 Johnston, S. ( 1994) Product Identity and Composition of SBP 1382 Insecticide Concentrate 12% Formula I: Supplemental to MRID 43184901. Unpublished study prepared by AgrEvo Environmental Health. 32 p. 43435701 Girard, M. ( 1994) SBP 1382 Concentrate 12% F1: Determination of Product Chemistry: Lab Project Number: 215. Unpublished study prepared by Roussel Uclaf Corp. 14 p. 43993601 Essig, K. ( 1996) SBP 1382/ Bioallethrin 10% 7.5% FI, Determination of Storage Stability and Corrosion Characteristics: Lab Project Number: 180: AR95 0101: AR94 0300. Unpublished study prepared by AgrEvo Environmental Health. 34 p. 43993701 Girard Andis, M. ( 1996) SBP 1382 Concentrate 12% F1 ( sic): Determination of Storage Stability and Corrosion Characteristics: Lab Project Number: 212: AR95 0242: AR95 0082. Unpublished study prepared by AgrEvo Environmental Health. 32 p. 00077182 Furmauer, D. ( 1980) GLC Procedure for the Determination of Resmethrin ( SBP 1382) Residues in Food Products. Procedure no. 1047 dated Nov 14, 1980. ( Unpublished study received Jun 29, 1981 under 432 547; submitted by Penick Corp., Lyndhurst, N. J.; CDL: 245420 A) 00123575 Penick Corp. ( 1979) Method and Test Results: SBP 1382. ( Compilation; unpublished study received Feb 28, 1979 under 432 547; CDL: 237712 A) 00128626 Mumma, R.; Vallejo, R.; Pitts, C. ( 1982) Persistence of Metabolism of 14C resmethrin on Greenhouse Grown Tomato Fruit, Lettuce and Field Grown Wheat. ( Unpublished study received May 25, 1983 under 432 487; prepared by Pennsylvania State Univ., Dept. of Entomology, Pesticide Research Laboratory and Graduate Study Center, submitted by Penick Corp., Lyndhurst, NJ; CDL: 250385 A) 00129282 Furmanec, D. ( 1982) Residue Studies on Various Commodities Exposed to 3% SBP 1382 in . . . Distillate During U. L. V. Spraying Tests in a Warehouse. ( Unpublished study received Oct 14, 1982 under 9H5210; submitted by Penick Corp., Lyndhurst, NJ; CDL: 248552 A); 89 p. 00159388 DeVries, M. ( 1986) Letter sent to A. Castillo dated May 15, 1986: Resmethrin and/ or metabolite determination in cattle resulting from treatment with SBP 1382, 3% Multipurpose Spray Formula III, EPA No. 432 635 for premise use of Resmethrin. Prepared by Penick Bio UCLAF Corp. 134 p. 40695812 Christopher, R. ( 1986) Distribution and Metabolism of cis and trans Resmethrin ( 5 Benzyl 3 furyl) methyl 2,2 dimethyl 3( 2 methyl propenyl) cyclopropanecarboxylate in Laying Hens. Unpublished study prepared by Texas A& M University. 181 p. 41239901 Frishman, A.; deVries, M.; Kwiatkowski, J.; et al. ( 1986) Resmethrin Food Handling Establishments Residue Study .... Unpublished study prepared by United States Testing 99 MRID Citation Reference Co., Inc. 627 p. 41239902 Frishman, A.; Kim, O.; deVries, M. ( 1986) Resmethrin Filter Paper Residue Deposit Study .... Unpublished study prepared by OK Analytical Laboratories. 40 p. 42009801 Meinen, V.; Bergman, J. ( 1991) Residue Study of Pyrethrins, Piperonyl Butoxide, and MGK 264 in Certain Food Commodities Resulting From Use as a Space in a Simulated Feed and Food Processing Situation: Lab Project Number: GLP 078. Unpublished study prepared by MGK Co. 145 p. 42009802 Meinen, V.; Bergman, J. ( 1991) Residue Study of Pyrethrins, Piperonyl Butoxide, and MGK 264 in Certain Food Commodities Resulting From Use as a Contact Spray in a Simulated Feed and Food Processing Situation: Lab Project Number: GLP 075. Unpublished study prepared by MGK Co. 146 p. 42009803 Meinen, V. ( 1991) Residue Study of Pyrethrins, Piperonyl Butoxide, and MGK 264 in Certain Food Commodities Resulting From Use as a Space Spray in a Warehouse Situation: Lab Project Number: GLP 077. Unpublished study prepared by MGK Co. 116 p. 42009804 Meinen, V. ( 1991) Residue Study of Pyrethrins, Piperonyl Butoxide, and MGK 264 in Certain Food Commodities Resulting From Use as a Contact Spray in a Warehouse Situation: Lab Project Number: GLP 076. Unpublished study prepared by MGK Co. 114 p. 42009805 Meinen, V.; Bergman, J. ( 1991) Residue Study of Pyrethrins, Piperonyl Butoxide, and MGK 264 in Certain Food Commodities and Surfaces Resulting From Use as an Intermediate Aerosol Spray in a Simulated Restaurant Situation: Lab Project Number: GLP 193. Unpublished study prepared by MGK Co. 199 p. 42992001 Jalali, K.; Krautter, G.; Ruzo, L. ( 1993) The Metabolism of ( 14C Alcohol) d trans Resmethrin in the Laying Hens Following Oral Administration for 3 Consecutive Days: Lab Project Number: 701E/ 380W: 701E/ 380W 1. Unpublished study prepared by PTRL East, Inc. and PTRL West, Inc. 203 p. 42992002 Jalali, K.; Krautter, G.; Ruzo, L. ( 1993) The Metabolism of ( 14C Alcohol) d trans Resmethrin in the Lactating Goat Following Oral Administration for 3 Consecutive Days: Lab Project Number: 700E/ 379W: 700E/ 379W 1. Unpublished study prepared by PTRL East, Inc. and PTRL West, Inc. 235 p. 44048401 Toia, R.; Kimmel, E.; Ruzo, L. ( 1996) Metabolism of ( 14C alcohol) d trans Resmethrin in Wheat, Lettuce and Tomato Plants: Lab Project Number: 298W/ 299W/ 300W 1: 298W/ 299W/ 300W: 300W. Unpublished study prepared by PTRL West, Inc. 1021 p. Environmental Fate and Effects Studies 00153058 Battelle Columbus Laboratories ( 1984) [ Hydrolysis of SBP 1382 Resmethrin]. Unpublished study. 216 p. 00153059 Battelle Columbus Laboratories ( 1984) [ Photolysis of SBP 1382 Resmethrin: Final Report]. Unpublished study. 77 p. 42639002 Jalali Araghi, K.; Ruzo, L.; Shepler, K. ( 1992) Sunlight Photodegradation of ( carbon 14) alcohol d trans Resmethrin in Sea Water by Natural Sunlight: Lab Project Number: 333W 1: 333W. Unpublished study prepared by PTRL West, Inc. 81 p. 41913601 Ross, M.; Ewing, A.; Ruzo, L. ( 1990) Aerobic Metabolism of ? Carbon 14 alcohol| dtrans Resmethrin in Sandy Loam Soil: Lab Project Number: 236W 1: 236W. Unpublished study prepared by Pharmocology and Toxicology Research Laboratory. 98 p. 42298401 Ross, M.; Ewing, A.; Ruzo, L. ( 1992) Anaerobic Aquatic Metabolism of carbon 14 alcohol| d trans Resmethrin: Lab Project Number: 293W 1: 293W. Unpublished study prepared by PTRL West, Inc. 144 p. 420443003 Ross, M.; Ewing, A.; Ruzo, L. ( 1991) Aerobic Aquatic Metabolism of ? carbon 14 alcohol| d trans Resmethrin: Lab Project No: 292W 1: 292W. Unpublished study prepared by PRTL West, Inc. 107 p. 42143701 Wang, W. ( 1991) Adsorption and Desorption of carbon 14 Resmethrin| in Four Soils: Lab Project Number: XBL 91066: RPT0081. Unpublished study prepared by 100 MRID Citation Reference XenoBiotic Labs., Inc. 74 p. 43157901 Estigoy, L.; Shepler, K.; Skinner, W. ( 1993) Aged Leaching of (( carbon 14) alc) dtrans Resmethrin in Sandy Loam Soil: Lab Project Number: 404W 1: 404W. Unpublished study prepared by PTRL West, Inc. and Roussel Uclaf Corp. 77 p. 00153022 Kaufman, D. ( 1985) Degradation and Movement of Cis and Trans resmethrin in Soil. Unpublished study prepared by US Dept. of Agriculture, Beltsville Agricultural Research Center West, Pesticide Degradation Laboratory. 37 p. 42639001 Blakemore, G.; Stuerman, L.; Jalali Araghi, K.; et al. ( 1992) Uptake, Depuration and Bioconcentration of ( carbon 14) alcohol d trans Resmethrin by Bluegill Sunfish: Lab Project Number: 347W: 347W 1: ABC 39720. Unpublished study prepared by PTRLWest Inc. and ABC Labs. 156 p. 0160000 Hudson, R.; Tucker, R.; Haegele, M. ( 1984) Handbook of toxicity of pesticides to wildlife: Second edition. US Fish and Wildlife Service: Resource Publication 153. 91 p. 0008885 Ross, D. B.; Roberts, N. L.; Phillips, C. N. K. ( 1979) The Acute Oral Toxicity ( LDI50^) of Resmethrin to the Ring necked Pheasant: MCT 42WL/ 7997. ( Unpublished study received Dec 2, 1981 under 432 487; prepared by Huntingdon Research Centre, England, submitted by Penwick Corp., Lyndhurst, N. J.; CDL: 246395 F) 0008886 Ross, D. B.; Roberts, N. L.; Phillips, C. N. K. ( 1979) The Acute Oral Toxicity ( LDI50^) of Resmethrin to the Mallard Duck: MCT 41 WL/ 7993. ( Unpublished study received Dec 2, 1981 under 432 487; prepared by Huntingdon Research Centre, England, submitted by Penwick Corp., Lyndhurst, N. J.; CDL: 246395 G) 00143653 Schafer, E.; Bowles, W.; Hurlbut, J. ( 1983) The acute oral tox icity, repellency, and hazard potential of 998 chemicals to one or more species of wild and domestic birds. Arch. Environm. Contam. Toxicol. 12: 355 382. 41653601 Pederson, C. ( 1990) Resmethrin Technical: 8 Day Acute Dietary LC50 Study in Bobwhite Quail: Lab Project Number: BLAL 90 QC 153: RBT 90 106. 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