 1 U. S. ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, DC 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES PC code: 057001 DP Barcode: D329617 July 14, 2006 MEMORANDUM:

Subject: Revised Screening Ecological Risk Assessment for the Reregistration of MGK 264 Insecticide Synergist To: Cathryn O'Connell, RM 52 Special Review and Reregistration Division From: William P. Eckel, Ph. D. Environmental Fate and Effects Division Environmental Risk Branch II Thru: Tom Bailey, Branch Chief Environmental Fate and Effects Division Environmental Risk Branch II Attached is the Environmental Fate and Effects Division's ( EFED) environmental risk assessment for the reregistration of MGK 264 as a synergist for pyrethrin and pyrethroid insecticides for indoor/ outdoor use. The chapter has been revised to reflect responses to public comments, and also to reflect a reduced maximum outdoor use rate of 0.3 lb ai/ acre.

Major Findings. " Listed" ( endangered and threatened) freshwater fish may be at risk of mortality when twenty weekly applications are made at the new maximum outdoor use rate ( 0.3 lb/ acre). No acute Levels of Concern are exceeded for freshwater fish or invertebrates when only ten weekly applications are made.

Chronic risks ( decreased pup weight gain) in mammals are possible. The dietary based risk quotient for twenty weekly applications is greater than 0.42 (> 0.42) under default assumptions ( 35 day half life), for animals consuming short grass food items. The dose based risk quotients for 15 g and 35 g mammals exceed the chronic LOC for short grass, tall grass, and broadleaf plant/ small insect food categories. For 1000 g mammals, the chronic LOC is exceeded for animals consuming short grass food items only. The dose based RQ values range up to 3.6 for 15 g mammals consuming short grass. The no effect level ( NOAEL) for decreased pup weight gain was not established, so the calculated risk quotients are smaller than they would be if the no effect level was known. 2 Risks to estuarine/ marine species, and terrestrial and aquatic plants, and reproductive effects in birds could not be quantitatively assessed due to lack of data. However, " listed" estuarine/ marine organisms are presumed to be at acute risk due to the exceedence of the Level of Concern in freshwater fish after twenty ( 20) weekly applications. Likewise, birds are presumed to be at risk of reproductive effects, based on the exceedence of the Level of Concern in mammals.

A major uncertainty in this assessment is the lack of information on frequency and timing of application of MGK 264. The Master Label appears to allow daily application. A conservative assessment would therefore assume application on 365 days every year. For the purposes of this assessment, it has been assumed that application is done weekly, and 1 through 20 applications are made ( for aquatic exposure using PRZM EXAMS, or for Hoerger Kenaga terrestrial exposure analysis).

Environmental Fate. MGK 264 has the molecular formula C17H25NO2 and molecular weight 275.38. It is a liquid at room temperature and is slightly soluble in deionized water ( 15 mg/ L). The log octanol water partition coefficient ( Log Kow) is 3.70. Its vapor pressure is 9.5 x 10 5 mm Hg at 25 oC and 2 mm Hg at 150 oC, which puts it in the semi volatile range. The estimated Henry's Law constant is 2.85 x 10 7 atm m3/ mole at 25 oC.

MGK 264 is stable to hydrolysis, direct aqueous photolysis, and soil photolysis. Aerobic and anaerobic soil metabolism are very slow ( mean aerobic half life was 341 days). MGK 264 was moderately mobile in sand and sandy loam soils ( Koc = 636 in sand) and slightly mobile in silt loam and clay loam soils ( Koc = 3106 in clay loam). Adsorption increased with increasing organic matter content, as expected for a neutral organic molecule. MGK 264 aerosols in air are expected to be rapidly degraded ( half life ~ 1.4 hr) by reaction with ozone and hydroxyl radical based on structure activity relationships. Free radical reactions may also degrade MGK 264 in natural waters.

The physical properties and fate characteristics of MGK 264 indicate that it is a persistent compound, and that it will be moderately mobile in coarse soils ( sand and sandy loam). MGK 264 is slightly mobile in clay soils, which may serve as a sink. MGK 264 may partition to particulate matter in water. Volatilization from soil or water is not expected to be important. MGK 264 is expected to be an aerosol rather than in the gas phase ( as a result of spraying). The expected half life in air is short, so long range transport is not expected. The combined persistence and mobility may result in MGK 264 being found in surface and ground water. The log Kow value of 3.70 indicates a potential for bioconcentration in aquatic organisms.

Labeling Requirements. Technical MGK 264 should have a standard label warning of its toxicity to fish and invertebrates. Additional label warnings on end use products are not required at this time, and will likely depend on the toxicity characteristics of the co formulated active ingredients.

Data Needs. Our understanding of the exposure of aquatic and estuarine/ marine organisms would be improved by submission of data on aerobic aquatic metabolism ( guideline 162 4), anaerobic aquatic metabolism ( guideline 162 3), and indirect aqueous photolysis. These three studies would allow refinement of the modeled aquatic EECs, and possibly remove the presumption of risk to aquatic and estuarine/ marine organisms. 3 Potential ecological risks would be clarified by submission of acute toxicity data on estuarine/ marine fish, invertebrates, and mollusks ( guideline 72 3). Presently, we presume that there is a risk to estuarine/ marine species because of the presumed risk to freshwater species after twenty ( 20) applications. The guideline 72 3 studies will either confirm or deny the presumption of risk.

The measured log Kow value ( 3.70) indicates a potential for bioaccumulation in fish. Since we expect fish to be exposed to MGK 264, a fish bioaccumulation study ( guideline 165 4 ) would indicate if there is any potential for food chain effects in fish consumers.

The exposure of birds and mammals would be better understood if data on the dissipation of total foliar residues ( guideline 132 1a) were submitted. Due to lack of this data, a default half life of 35 days on foliage has been assumed. A measured foliar dissipation rate, if shorter than 35 days, might remove the presumption of chronic risk to mammals.

The potential chronic risks to birds would be clearer if a study on avian reproductive effects ( guideline 71 4) was submitted. Presently, we presume a chronic risk to birds because the chronic RQ for mammals exceeds the Level of Concern. The avian reproduction study would allow confirmation or removal of the presumption of risk to birds.

Endocrine Disruption. HED has concluded that MGK 264 shows no evidence of being an endocrine disruptor.

Endangered Species. Federally listed ( endangered and threatened) freshwater aquatic organisms may be at acute risk from exposure to contaminated water bodies receiving run off and spray drift from MGK 264 treated sites ( after twenty weekly applications). Listed mammals are also at chronic risk of reproductive effects if present in treated areas. We presume that estuarine/ marine organisms may also be at acute risk, based on the identified risk to freshwater organisms. We also presume that birds may be at risk of reproductive effects, based on the identified risk to mammals.

EFED cannot determine which species might be affected, because EFED's endangered species data base ( LOCATES) is based on co occurrence of the species with agricultural crops by county. Non agricultural use sites such as lawns and ornamental plants have not been specifically associated with any listed species. Because the lawn and ornamental plants use pattern may be geographically widespread, exposure of listed species cannot be ruled out.

To be meaningful, an endangered species assessment for MGK 264 would have to consider simultaneous exposure to the insecticides it is used to synergize, including pyrethrins, and pyrethroids, as well as the co synergist piperonyl butoxide. 4 Table of Contents Page 1. Problem Formulation 5 1.1. Source and Exposure Characteristics 5 1.2. Exposure Pathways 6 1.3 Analysis Plan 6 1.3.1. a. Terrestrial Organisms 6 1.3.1. b. Aquatic Organisms 7 1.3.1. c. Presumption of Risk 1.3.2 Ecological Effects and Assessment Endpoints 7 1.3.3. Assessment Endpoints 9 1.3.3. a. Aquatic Organisms 9 1.3.3. b. Terrestrial Organisms 9 1.3.4. Conceptual Model 9 2. Exposure and Effects Analysis 11 2.1 Environmental Fate Assessment 11 2.2. Exposure Analysis 11 2.2.1 Food Residues 11 2.2.2 Exposure Analysis ( Aquatic Ecosystems) 11 2.3. Ecological Response Analysis 14 2.4. Stressor Response Profile 15 2.4.1. Fish and Invertebrates 15 2.4.2. Birds 15 2.4.3. Mammals 15 3. Risk Characterization 16 3.1. Risk Estimation 16 3.1.1. Terrestrial Ecosystems 16 3.1.2. Aquatic Ecosystems 16 3.2. Risk Description 17 3.2.1 Endocrine Disruption 18 3.3 Endangered Species 18 4. References 20 Appendices 21 5 1. Problem Formulation 1.1. Source and Exposure Characteristics.

MGK 264 or N( 2 ethylhexyl) 5 norbornene 2,3 dicarboximide ( Figure 1) is an insecticide synergist. Synergists are chemicals that lack pesticidal effects of their own but enhance the pesticidal properties of other chemicals. MGK 264 is usually formulated with natural pyrethrins, piperonyl butoxide ( PBO), or synthetic pyrethroids and is an ingredient in numerous registered pest control products. It has numerous and varied commercial and residential applications, is available in a broad range of formulations, and is applied by wide variety of application methods. Commercial uses include application to non food plants, applications in food and non food handling commercial and agricultural structures and outdoor premises, housing for veterinary use, and direct application to non food animals. MGK 264 is not used on animals intended for human consumption. In addition, MGK 264 is currently registered for use in/ on all food items in food handling establishments where food and food products are held, processed, or prepared to control nuisance and food product contaminating insects such as ants, cockroaches, fleas and ticks. Residentially, it is used to control insects both inside the home, and outside on gardens, lawns and ornamentals, patios, and other outdoor structures, and is directly applied to pets. As a synergist, it inhibits the mixed function oxidase system of insects and reduces the oxidative breakdown of other pesticides like pyrethrum and synthetic pyrethroids. Comprehensive information on use patterns and formulations is provided in the MGK 264 Master Label ( C. Rodia, Use Closure Memo, 11/ 17/ 03) which was submitted to the EPA by MGK Company. This risk assessment for MGK 264 is based on the Master Label, as modified by EPA responses to public comments ( C. O'Connor, SRRD, personal communication 6/ 6/ 06), and a maximum label rate reduction from 2.2 to 0.3 lb ai/ acre.

According to information submitted by the registrant, most of the use of MGK 264 is for indoor/ residential insect control ( ant & roach, crack & crevice, flying insect killer, personal insect repellent, total release aerosol, wasp & hornet, fog), direct application to animals ( barn, horse, pet, poultry), veterinary uses, and disease vector control.

While any of these uses may result in some release to the environment, the outdoor application to lawns and ornamental plants is the most likeliest to result in exposure of non target organisms. 6 Figure 1. Structure of MGK 264 1.2. Exposure Pathways.

Outdoor ground applications of MGK 264 may result in residues at the use site that terrestrial organisms can ingest, inhale or touch ( i. e., dermal exposure). The Master Label ( Table 2) does not list any aerial application equipment; therefore aerial application will not be considered in this assessment. Additionally, MGK 264 may reach offsite terrestrial or aquatic systems through spray drift during application or from surface water run off. Indirect exposure through the food chain may potentially occur in both the terrestrial and aquatic ecosystem.

1.3. Analysis Plan.

Risks to terrestrial and aquatic organisms will be assessed as described below. Applications were assumed to occur either once, or numerous times at weekly intervals, since the Master Label only limits applications to no more than daily. The risk assessment will focus on the toxic effects of MGK 264 alone, rather than any effects caused by its synergistic interaction with other active ingredients ( except where only mixture toxicity data is available). Such effects are best addressed by an assessment of the formulated products of the other active ingredients.

1.3.1. a. Terrestrial Organisms. Onsite exposure of non target birds and mammals to MGK 264 via ingestion will be assessed by assuming 100% of their diet is obtained from onsite sources using the Hoerger Kenaga nomogram for estimating residues on plants, seeds, insects, and other food items and the T REX version 1.2.3 tool ( USEPA 2005). Offsite non target bird and mammal exposures to plant and insect residues will not be quantitatively evaluated in this screening assessment because onsite plant and insect residue levels will be higher than offsite residue levels. Because 100% of the diet is assumed to come from onsite sources, and incidental soil ingestion in contrast represents a minor exposure component, incidental soil ingestion will not be quantitatively evaluated. For the scenario considered, acute and chronic risk quotient C H 3 C H 3 N O C H 2 O 7 ( RQ) values will be calculated by dividing estimated exposure concentrations ( EECs) by the most sensitive toxicity endpoints for acute exposure ( median lethal dose, LD50) and chronic exposure ( no observed adverse effect level, NOAEL), respectively. Due to lack of foliar dissipation data, a default half life of 35 days will be used in calculating EECs. The observed stability of MGK 264 in laboratory fate experiments supports the 35 day assumption. The RQ values will then be compared to standard Levels of Concern ( LOCs).

1.3.1. b. Aquatic Organisms. EECs of MGK 264 in an aquatic system due to run off and spray drift from a ground application to lawn or ornamentals, the uses most likely to result in the highest aquatic EECs, will be modeled using PRZM EXAMS. These modeled exposure concentrations will then be divided by the most sensitive of 96 h LC50 values for fish and 96 hr LC50 or EC50 ( or 48 h EC50 for daphnids) for aquatic invertebrates, to calculate acute RQs. No chronic data for fish or aquatic invertebrates exist so chronic risks can not be assessed. Additionally, acute and chronic risks to estuarine/ marine fish and invertebrates could not be assessed because no acute or chronic toxicity studies for these organisms were submitted by the registrant, and none were found in the open literature ( ECOTOX 2004).

The PRZM EXAMS analysis will represent the combined exposure in the EFED standard surface water model due to run off and 1% spray drift from ground application. The Florida and Pennsylvania PRZM turf scenarios will be used to represent the effect of application to turf, lawns, and ornamental plants.

1.3.1. c. Presumption of Risk. RQ values will be compared to standard Levels of Concern ( LOCs). LOCs are the Agency's interpretative policy and are used to analyze potential risk to non target organisms and the need to consider regulatory action. If model calculations show that exposures will produce RQ values that exceed the LOCs for endangered or nonendangered species, then modeling refinements or alternative application rates/ scenarios may be investigated to determine if there are alternative application rates or methods that do not result in unacceptable adverse effects for these non target species.

1.3.2. Ecological Effects and Assessment Endpoints.

Assessment endpoints are defined as " explicit expressions of the actual environmental value that is to be protected." Defining an assessment endpoint involves two steps: 1) identifying the valued attributes of the environment that are considered to be at risk, and 2) operationally defining the assessment endpoint in terms of an ecological entity ( e. g., a community of fish and aquatic invertebrates) and its attributes ( i. e., survival and reproduction). Therefore, selection of the assessment endpoints is based on valued entities ( i. e., ecological receptors), the ecosystems potentially at risk, the migration pathways of pesticides, and the routes by which ecological receptors are exposed to pesticide related contamination. The selection of clearly defined assessment endpoints is important because they provide direction and boundaries in the risk assessment for addressing risk management issues of concern.

Ecosystems potentially at risk are expressed in terms of the broad taxa ( e. g., birds, mammals, fish) selected as assessment endpoints. The typical attributes for screening level pesticide ecological risks are survival, reproduction and growth for both aquatic and terrestrial animal species. Aquatic animal species of potential concern include freshwater fish and invertebrates, estuarine/ marine fish and invertebrates, and amphibians. Terrestrial animal species of potential concern include birds, mammals, and beneficial insects. In order to protect threatened and endangered species, all endpoints are measured at the individual level. Although all endpoints are measured at the individual level, they provide insight about risks at higher 8 levels of biological organization ( e. g. populations and communities). For example, pesticide effects on individual survivorship have important implications for both population rates of increase and habitat carrying capacity.

For terrestrial and semi aquatic plants, the screening assessment endpoint is the perpetuation of populations of non target species ( crops and non crop plant species). Existing testing requirements have the capacity to evaluate emergence of seedlings and vegetative vigor. Although it is recognized that the endpoints of seedling emergence and vegetative vigor may not address all terrestrial and semi aquatic plant life cycle components, it is assumed that impacts at emergence and in active growth have the potential to impact individual competitive ability and reproductive success.

For aquatic plants, the assessment endpoint is the maintenance and growth of standing crop or biomass. Measurement endpoints for this assessment endpoint focus on algal and vascular plant ( i. e., duckweed) growth rates and biomass measurements.

The ecological relevance of selecting the above mentioned assessment endpoints is as follows: 1) complete exposure pathways exist for these receptors; 2) the receptors may be potentially sensitive to pesticides in affected media and in residues on plants, seeds, and insects; and 3) the receptors could potentially inhabit areas where pesticides are applied, or areas where runoff and/ or spray drift may impact the sites because suitable habitat is available.

Each assessment endpoint requires one or more " measures of ecological effect," which are defined as changes in the attributes of an assessment endpoint itself or changes in a surrogate entity or attribute in response to exposure to a pesticide. Ecological measurement endpoints for the screening level risk assessment are based at a minimum on a suite of registrant submitted toxicity studies performed on a limited number of organisms in the following broad groupings:

° Birds ( mallard duck and bobwhite quail acute oral, dietary and reproductionguideline tests) which are also used as surrogates for terrestrial phase amphibians and reptiles, ° Mammals ( laboratory rat acute and reproductive guideline tests), ° Freshwater Fish ( bluegill sunfish and rainbow trout acute and early life stage guideline tests) which are also used as a surrogate for aquatic phase amphibians, ° Freshwater invertebrates ( Daphnia magna acute and reproduction guideline tests), ° Estuarine/ marine fish ( Sheepshead Minnow or silversides acute or early life stage guideline tests), ° Estuarine/ marine invertebrates ( Crassostrea virginica shell deposition or embryo/ larval development and Americamysis bahia, gammarid amphipods, or penaeid shrimp acute and reproduction guideline tests), ° Terrestrial plants ( corn, onion, ryegrass, wheat, buckwheat, cucumber, soybean, sunflower, tomato, and turnip vegetative vigor and seedling emergence guideline tests), and ° Algae and aquatic plants ( Lemna gibba and Selenastrum capricornutum).

Within each of these very broad taxonomic groups, the most sensitive acute and chronic endpoint is selected from the available test data, as the data sets allow.

The risk assessment will focus on the toxic effects of MGK 264 alone, rather than any effects caused by its synergistic interaction with other active ingredients ( except where only mixture toxicity data is available). Such effects are best addressed by an assessment of the 9 formulated products of the other active ingredients. The risk assessment will be limited to organisms for which we have toxicity data ( as described below). Risk presumptions may be extended to similar organisms ( e. g., estuarine/ marine organisms may be presumed to be at risk if freshwater aquatic organisms are at risk).

1.3.3. Assessment Endpoints.

1.3.3. a. Aquatic Organisms.

Based on the available data and the ecosystems believed to be at risk, the assessment endpoint is death of the endangered or non endangered non target organism ( fish or invertebrate). The stressor is exposure to MGK 264 alone. Chronic risks to fish or invertebrates cannot be assessed due to lack of toxicity data. Risks to benthic organisms also cannot be assessed due to lack of data.

1.3.3. b. Terrestrial Organisms.

Because MGK 264 was practically non toxic to the mallard, bob white quail and laboratory rat, and no deaths were observed even at the highest doses tested, we presume that there is no acute risk to birds or mammals. Based on the chronic data for the rat, the assessment endpoint is decreased pup weight gain. This effect may lead to adverse outcomes such as reduced survival of young animals.

1.3.4. Conceptual Model.

The conceptual model ( Figure 2) diagrams the relationships between the stressor and the ecological entities potentially exposed. It should be noted that these entities are likely exposed to other chemical and environmental stressors ( e. g., habitat loss) as well, but only the effects of the pesticide are considered in this assessment. Based on the foregoing discussion, the conceptual model for exposure of non target fish and invertebrates involves ground application of MGK 264 ( stressor) to a terrestrial site ( lawn or ornamental plants) resulting in spray drift or run off to the aquatic ecosystem. The non target aquatic organisms are then exposed to MGK 264 in the water column. Exposure to the stressor in sufficient concentration may result in death of the non target fish or invertebrates or reproductive impairment.

Exposure of birds and mammals in terrestrial environments is expected to primarily be via consumption of spray contaminated food items ( foliage, seeds, insects, etc.). Exposure in sufficient concentration is expected to lead to mortality and decreased reproductive success. 10 Figure 2. Conceptual Model for Ground Applications of MGK 264 to Lawn and Ornamental Plants Source: Ground application to lawn and ornamental plant

Stressor: MGK 264TM ( synergist)

Offsite Potential Exposure Pathways:  surface water run off and spray drift Onsite Potential Exposure Pathway: Foliage deposits Non target Receptors: freshwater fish, estuarine/ marine fish, freshwater invertebrates, estuarine/ marine invertebrates, aquatic and terrestrial plants Non target receptors: Birds, mammals, beneficial insects, other terrestrial invertebrates Measurement Endpoints: acute and chronic ( reproductive) effects on birds, reptiles, terrestrial phase amphibians and mammals; acute and chronic effects on aquatic organisms 11 2. Exposure and Effects Analysis 2.1 Environmental Fate Assessment MGK 264 has the molecular formula C17H25NO2 and molecular weight 275.38. It is a liquid at room temperature and is slightly soluble in deionized water ( 15 mg/ L). The log octanolwater partition coefficient ( Log Kow) is 3.70 ( SRC PhysProp database). Its vapor pressure is 9.5 x 10 5 mm Hg at 25 oC and 2 mm Hg at 150 oC, which puts it in the semi volatile range ( The normal boiling point estimated by the MPBPWIN v1.40 program in EPISuite was 443 oC). The estimated Henry's Law constant is 2.85 x 10 7 atm m3/ mole at 25 oC ( SRC PhysProp database). Appendix A provides a summary and evaluation of Subdivision N fate guideline studies submitted by the registrant. The following environmental fate assessment and the inputs used for terrestrial exposure and aquatic exposure models are based on results from these studies.

MGK 264 is stable to hydrolysis, direct aqueous photolysis, and soil photolysis. Aerobic and anaerobic soil metabolism are very slow ( mean aerobic half life was 341 days). MGK 264 was moderately mobile in sand and sandy loam soils ( Koc = 636 in sand) and slightly mobile in silt loam and clay loam soils ( Koc = 3106 in clay loam). Adsorption increased with increasing organic matter content, as expected for a neutral organic molecule. MGK 264 aerosols in air are expected to be rapidly degraded ( half life ~ 1.4 hr) by reaction with ozone and hydroxyl radical based on structure activity relationships ( Hazardous Substances Data Bank monograph for MGK 264, found at toxnet. nlm. nih. gov). Free radical reactions may also degrade MGK 264 in natural waters.

The physical properties and fate characteristics of MGK 264 indicate that it is a persistent compound, and that it will be mobile in coarse soils ( sand and sandy loam). MGK 264 is immobile in clay soils, which may serve as a sink. MGK 264 may partition to particulate matter in water. Volatilization from soil or water is not expected to be important. MGK 264 is expected to be an aerosol rather than in the gas phase ( as a result of spraying). The expected half life in air is short, so long range transport is not expected. The combined persistence and mobility may result in MGK 264 being found in surface and ground water. The Log Kow value of 3.70 ( SRC PhysProp Database) indicates a potential for bioconcentration in aquatic organisms, although the fish bioaccumulation study has previously been waived. This study is now being requested.

2.2. Exposure Analysis. The following sections describe the quantitative assessment of exposure for terrestrial and aquatic organisms as outlined in the Analysis Plan.

2.2.1. Food Residues.

Hoerger and Kenaga ( 1972) as modified by Fletcher et al. ( 1994) empirically derived residue concentrations on avian and mammalian dietary food items immediately following application of any pesticide at 1 pound of active ingredient per acre ( lb ai/ A). These EECs are given in Table 1. 12 Table 1. EECs on Avian and Mammalian Food Items for a 1 lb ai/ A Application of Any Pesticide Food Item EEC ( ppm) Predicted Maximum Residue ( 1) EEC ( ppm) Predicted Mean Residue ( 1) Short grass 240 85 Tall grass 110 36 Broad leaved/ forage plants, and small insects 135 45 Fruits, pods, seeds, and large insects 15 7 Specific residue levels for MGK 264 uses and exposure of birds and mammals were modeled with the T REX model ( USEPA 2005), which adjusts the Hoerger Kenaga nomogram exposure for the MGK 264 application rate, adjusts toxicity results based on allometric body relationships and calculates RQs. It was assumed that MGK 264 was applied once at the maximum outdoor use rate ( 0.3 lb ai/ acre). One, two, three, 10 and 20 weekly applications were modeled because there was no label limit for number of applications. The default assumption for the decay rate on foliage ( 35 day half life) was used. This assumption is supported by the observed stability of MGK 264 in laboratory fate experiments. Table 2 gives the predicted maximum residues of MGK 264 that are expected to occur on selected avian or mammalian dietary food items.

Table 2. Maximum EECs on Avian and Mammalian Food Items for MGK 264 Application at the Maximum Outdoor Use Rate ( 0.3 lb ai/ acre) No. of applications Short Grass ( ppm) Tall Grass ( ppm) Broad leaved / forage plants, small insects ( ppm) Fruits/ pods/ seeds/ large insects ( ppm) 1 72 33 41 4.5 2 135 62 76 8.4 3 189 87 106 12 10 417 191 235 26 20 521 239 283 33 2.2.2. Exposure Analysis ( Aquatic Ecosystems).

Exposure due to terrestrial application ( lawns and ornamental plants) was assessed using the standard farm pond scenario in the PRZM EXAMS models. The Pennsylvania and Florida turf scenarios were used to represent use on turf or ornamental plants in the northeast and southeast, respectively. All exposure analyses were done at maximum application rates with assumed intervals and number of applications.

The following input parameters ( Table 3) were used for the linked PRZM and EXAMS models. The values were selected in accordance with the EFED Input Parameter Guidance dated February 28, 2002. The Pennsylvania and Florida turf scenarios were chosen to represent use on lawns and ornamental plants. The standard surface water scenario was used. 13 Table 3. PRZM EXAMS Input Parameters Input Parameter Value Reference/ Comment Application Rate ( max.) 0.3 lb ai/ acre Post RED negotiation with registrant Application Interval 7 days Assumed: Master Label allows daily application Number of Applications 1, 2, 3, 10, 20 Because Master Label does not limit number of applications assessed a number of alternatives Organic Carbon Partition Coefficient ( Koc) 899 mL/ g MRID 426225 01, 426225 02 ( used lowest non sand Koc; studies ranged from 636 to 3106 mL/ g) Solubility in Water 150 mg/ L EFED Input parameter Guidance ( Feb. 28 2002) requires use of 10x solubility ( 15 mg/ L) in PRZMEXAMS modeling Soil Metabolism Half Life 430 days MRID 431945 01 ( 90th percentile upper bound, per Input Parameter Guidance, on values of 294 and 388 days) Benthic Metabolism Half Life Stable No data Aquatic Metabolism Half Life 860 days No study submitted: value is 2x soil metabolism half life input value Hydrolysis Half Life Stable MRID 422226 01, 423550 01 Aqueous Photolysis Half Life Stable MRID 422226 02, 423550 02 Molecular Weight ( g/ mole) 275.39 From molecular formula Henry's Law Constant 2.85 E 7 atm m3/ mol Calculated from vapor pressure and solubility Vapor Pressure 1.8 E 5 torr From EPISuite experimental database Chemical Application Method ( CAM) 2 Implies linear foliar application based on crop canopy Incorporation Depth 0 cm Assumed no incorporation; no information on Master Label Application Efficiency 0.99 Value for ground application Spray Drift Fraction 0.01 Value for ground application Application Date April 1 Assumed: no information on Master Label The results of the PRZM EXAMS modeling are given in Table 4. These water column concentrations will be used as the measures of exposure for aquatic organisms such as fish and invertebrates. The Florida peak EECs ( 4 to 77 ppb) were slightly higher than the Pennsylvania EECs ( 2.7 to 70 ppb), depending on the number of applications. The differences are likely due to environmental factors ( soil and rainfall) encoded in the scenarios. 14 Table 4. PRZM EXAMS Results ( EECs) for Surface Water Scenario ( in ppb) No. of applications Peak 96 hour 21 days 60 days 90 days Yearly Avg. of Yearly Florida Turf Scenario 1 4.0 4.0 3.8 3.5 3.5 3.1 2.5 2 8.0 7.9 7.5 7.0 6.9 6.2 4.9 3 11.9 11.7 11.1 10.5 10.2 9.3 7.4 10 41.2 40.7 39.2 37.0 36.3 32.1 25.9 20 77.3 76.2 74.0 71.2 70.3 63.2 53.7 Pennsylvania Turf Scenario 1 2.7 2.6 2.5 2.4 2.3 2.2 1.6 2 5.4 5.3 5.2 4.9 4.9 4.6 3.3 3 8.4 8.3 8.0 7.7 7.7 7.2 5.1 10 32.6 32.4 31.3 29.5 29.1 26.4 19.7 20 70.4 69.7 67.5 64.4 63.0 58.2 43.1 2.3. Ecological Response Analysis.

Appendix B summarizes and evaluates the registrant submitted ecotoxicity studies. The following effects analysis and selection of endpoints for use in the screeing analysis are based on these studies. The registrant has submitted the basic freshwater acute fish and daphnid toxicity studies but no data for estuarine/ marine species. Two bird subacute dietary toxicity studies and acute oral toxicity studies were provided. No aquatic or avian chronic studies were conducted. Both rat acute oral and multi generation reproduction studies from HED are also listed. The toxicity values selected for use in calculating RQs, their toxicity categories, and MRIDs are provided in Table 5.

Table 5. Acute MGK 264 Toxicities to Fish, Daphnids, and Birds, and Acute and Chronic Toxicity to Mammals Taxonomic Group Animal ( guideline) Toxicity Endpoint Effect Toxcity Category MRID and Classification Freshwater fish Rainbow Trout ( 72 1) 96 h LC50 = 1.4 ppm Mortality Moderately toxic 41911501 Core Bluegill Sunfish ( 72 1) 96 h LC50 = 2.4 ppm Mortality Moderately toxic 41819701 Core Freshwater invertebrate Daphnid ( 72 2) 48 h EC50 = 2.3 ppm Immobilization ( as surrogate for mortality) Moderately toxic 41526102 Core Bird ( dietary) Bobwhite Quail ( 71 2a) 5 day LC50 > 5620 ppm ( no deaths) Practically nontoxic 41687301 Core Mallard Duck ( 71 2b) 5 day LC50 > 5620 ppm ( no deaths) Practically nontoxic 41526102 Core Bird ( acute oral) Bobwhite Quail Single dose LD50 > 2250 mg/ kg bw ( no deaths) Practically nontoxic 41821501 Core Mallard Duck Single dose LD50 > 2250 mg/ kg bw ( no deaths) Practically nontoxic 41821502 Core Mammal Rat ( acute) LD50 > 20,000 mg/ kg bw* ( no deaths) Practically nontoxic 42155701 Core Rat ( chronic) LOAEL = 1250 mg/ kg diet** ( most sensitive reproduction endpoint was reduced body weight gain in pups)  41752305 * Contains multiple active ingredients ** The lowest concentration tested 15 2.4. Stressor Response Profile 2.4.1 Fish and Invertebrates. The available studies show that MGK 264 is moderately toxic to rainbow trout, bluegill sunfish, and daphnids ( LC50 and EC50 values ranged from 1.4 to 2.4 ppm).

2.4.2. Birds. MGK 264 is practically nontoxic to bobwhite quail and mallard duck on an acute basis ( single dose LD50s > 2250 mg/ kg bw) and dietary basis ( 5 day LC50s > 5620 ppm). No mortality was observed at any dose level, thus there is no toxicity endpoint with which to conduct a risk assessment.

2.4.3. Mammals. MGK 264 is practically nontoxic on an acute basis to the laboratory rat ( LD50 > 20,000 mg/ kg body weight or 400,000 ppm in diet). No mortality was observed at any dose level, thus there is no toxicity endpoint with which to conduct an acute risk assessment.

The multi generation reproduction study yielded a LOAEL of 1250 mg/ kg diet, with an endpoint of reduced body weight gain in the pups. A NOAEL was not observed in the study. 16 3. Risk Characterization 3.1 Risk Estimation.

3.1.1. Terrestrial Ecosystems.

Chronic risk quotients for mammals ( as represented by rats) are given in Table 6a and 6b. The RQ values are based on a value of < 62.5 mg/ kg body weight since the chronic LOAEL value for rats was 1250 mg/ kg diet and no NOAEL was observed ( see Table 5), and the maximum estimated exposure concentrations given in Table 2. The Level of Concern ( dietary based RQ = 1.0) is not exceeded for any number of applications, however chronic ( reproductive) risk in mammals cannot be precluded because a no effect level ( NOAEL) was not obtained experimentally. The dose based RQ values for 20 applications, however, exceeded the LOC for 15 g and 35 g mammals ( short grass, tall grass and broadleaf plant/ small insects foods) and 1000 g mammals ( short grass). Until a definitive NOAEL is established, there is a presumption of reproductive risk to mammals.

Table 6a. Dietary Based Chronic Risk Quotients for Mammals ( Rat) ( Assessment Endpoint: Reduced Weight Gain in Pups) Diets Frequency of Applications ( 1250 mg/ kg diet) 1 2 3 10 20 Short grass > 0.06 > 0.11 > 0.15 > 0.33 > 0.42 Tall grass > 0.03 > 0.05 > 0.07 > 0.15 > 0.19 Broadleaf plants/ sm insects > 0.03 > 0.06 > 0.09 > 0.19 > 0.23 Fruits/ pod/ lg insects > 0.00 > 0.01 > 0.01 > 0.02 > 0.03 Note: Bold RQ indicates that the chronic Level of Concern ( RQ = 1) is exceeded .

Table 6b. Dose Based Risk Quotients for 15 g, 35 g and 1000 g Mammals ( 20 applications)

Diets 15 gram 35 gram 1000 gram Short grass > 3.6 > 3.1 > 1.7 Tall grass > 1.7 > 1.4 > 0.8 Broadleaf plants/ sm insects > 2.0 > 1.7 > 0.9 Fruits/ pod/ lg insects > 0.23 > 0.19 > 0.1 Note: Bold RQ indicates that the chronic Level of Concern ( RQ = 1) is exceeded .

3.1.2. Aquatic Ecosystems.

RQs for freshwater fish ( as represented by the rainbow trout and bluegill sunfish) and freshwater invertebrates ( as represented by Daphnia magna) are given in Table 7. The RQ values are based on the LC50 and EC50 values given in Table 5 and the peak estimated exposure concentrations given in Table 4. 17 Table 7. Acute Risk Quotients for Freshwater Organisms ( Assessment Endpoint: Death or Immobilization) Test Species 1 appl. 2 appl. 3 appl. 10 appl. 20 appl. PRAM EXAMS Florida Turf Scenario rainbow trout < 0.05 < 0.05 < 0.05 < 0.05 0.055 bluegill sunfish < 0.05 < 0.05 < 0.05 < 0.05 < 0.05 Daphnia < 0.05 < 0.05 < 0.05 < 0.05 < 0.05 PRZM EXAMS Pennsylvania Turf Scenario rainbow trout < 0.05 < 0.05 < 0.05 < 0.05 0.050 bluegill sunfish < 0.05 < 0.05 < 0.05 < 0.05 < 0.05 Daphnia < 0.05 < 0.05 < 0.05 < 0.05 < 0.05 Note: Bold RQs exceed endangered species Level of Concern.

No acute aquatic LOC ( RQ = 0.5) is exceeded for rainbow trout, bluegill sunfish, and daphnid at up to 20 applications of MGK 264. Endangered (" listed") species LOC ( RQ = 0.05) is exceeded only for rainbow trout with > 10 applications ( Florida) or > 10 applications ( Pennsylvania).

3.2. Risk Description.

MGK 264 is a synergist for pyrethrin, and pyrethroid insecticides. It is often used in combination with another synergist, piperonyl butoxide. This enables the same degree of insect pest control to be achieved with a lower application rate of the synergized insecticide.

In this assessment, a revised maximum application rate of 0.3 lbs a. i./ A for lawn insect control is used. Because of nonspecific application instructions on the label ( apply whenever it is necessary) an arbitrary application frequency of up to 20 applications at 7 day intervals for lawn and ornamental scenarios is used. The assumptions of a seven day application interval and the number of applications are both arbitrary, and a major source of uncertainty in the assessment.

Only outdoor uses of MGK 264 were assessed in this document, because indoor uses are considered unlikely to result in exposures to wildlife. However, the large majority of MGK 264 use in indoors. Thus, the risks described here should be considered in that light.

The risks deemed to be of concern in this assessment include acute toxicity ( death, or immobilization followed by predation) in " listed" freshwater fish and invertebrates ( assuming 20 weekly applications), and chronic toxicity ( reduced weight gain of pups) in mammals. By extension, we would expect adverse acute effects in " listed" estuarine/ marine animals, and adverse reproductive effects in birds because of the effects seen in freshwater fish and mammals, respectively.

The presumption of acute risk to " listed" freshwater and estuarine/ marine organisms could be removed if the number of applications was limited to 10 ( ten) with an interval of 7 days.

Because MGK 264 is never used alone, its adverse effects must be considered in light of the other active ingredients used. Generally speaking, MGK 264 is less toxic to the species of concern for pyrethrins and pyrethroids ( aquatic invertebrates). However, the effect of MGK 264 ( blocking de toxifying enzymes in invertebrates) makes a given dose of pyrethrin/ pyrethroid more toxic. This synergistic effect, by the same token, allows less pyrethrin/ pyrethroid to be used to achieve a desired level of insect pest control. Thus, should the MGK 264 and 18 pyrethrin/ pyrethroid become separated by fate processes ( such as their widely different solubilities), then the lower amount of pyrethrin/ pyrethroid used may cause fewer adverse effects. If, however, invertebrates are exposed to both active ingredients ( MGK 264 and pyrethrin/ pyrethroid) simultaneously, then there is a potential for greater adverse effects than if exposure was to the pyrethrin/ pyrethroid alone. This might occur also if the pyrethroid or pyrethrin is present in the sediment of a water body, and MGK 264 is introduced into the system at a later time.

The synergistic effect of MGK 264 combined with the synthetic pyrethroids deltamethrin and fenvalerate on the aquatic snail Lymnaea acuminata was studied. The results show significant decreases in the LC10, LC50, and LC90 values of both pyrethroids. With a 1: 5 mixture of pyrethroid + MGK 264, the synergist ratios for LC50 at 48 hrs were 25x and 6.13x for deltamethrin and fenvalerate, respectively ( Sahay and Agarwal, 1997). In a separate experiment, the synergist effect of MGK 264 on fenvalerate resistant German cockroaches was studied. The results showed that MGK 264 reduced the fenvalerate LC50 resistance ratio by 55 fold from the original 825 fold level ( Danxia Wu et al. 1998). These studies illustrate the increase in toxicity that may be expected from simultaneous exposure to MGK 264 and representative pyrethroid insecticides.

Terrestrial mammals may be risk of reduced pup weight gain application of MGK 264 to food items. This is uncertain because the no effect level for this toxic endpoint is not known. The risk quotients given in Tables 6a and 6b are minimums because they were calculated using a lowest adverse effect level ( LOAEL). Low weight gain in pups may lead to a lower survival rate. This may result in food chain disruptions, with lower populations of the affected mammals for predators, and overpopulation of animals or plants that the affected mammal consumes.

This assessment has considered exposure to MGK 264 itself, and not to any possible degradates. While eight degradates were noted in the aerobic soil metabolism study, at up to 15% or the applied radiation, none of them were specifically identified by chemical formula or structure. It is likely that reaction would occur at the double bond of the norbornene ring ( epoxidation) or that there would be a ring opening of the carboximide ring.

3.2.1. Endocrine Disruption. The Health Effects Division has determined that MGK 264 has no apparent effects on the endocrine system.

3.3. Endangered Species 3.3.1 Direct Effects Federally listed ( endangered and threatened) freshwater fish may be at acute risk from exposure to contaminated water bodies receiving run off and spray drift from MGK 264 treated sites after twenty weekly applications. . We presume that estuarine/ marine organisms may also be at acute risk, based on the identified risk to freshwater organisms.

Listed mammals may be at chronic risk of reproductive effects if present in treated areas We presume that birds may be at risk of reproductive effects, based on the identified risk to mammals.

EFED has no data on the toxicity to insects of MGK 264 by itself. There are no registered products that contain only MGK 264 as an active ingredient, because of its use as a synergist for other insecticides. Thus, we are unable to determine if there are potential direct effects on Listed insect species, where MGK 264 is the sole stressor. 19 EFED cannot determine which species might be exposed, because EFED's endangered species data bases are based on co occurrence of the species with agricultural crops by county. Because the lawn and ornamental plants use pattern may be geographically widespread, exposure of listed species cannot be ruled out.

3.3.2 Indirect Effects Based on the potential direct effects, taxa reliant on freshwater or estuarine fish, birds or mammals, may be at indirect risk of adverse effects.

To be meaningful, an endangered species assessment for MGK 264 would have to consider simultaneous exposure to the insecticides it is used to synergize, including pyrethrins, pyrethroids, and the co synergist piperonyl butoxide. 20 4. References Danxia Wu et al., 1998, Pesticide Biochemistry and Physiology 61, pp. 53 62.

EFED Input Parameter Guidance, February 28, 2002.

EFED interim standard Rice Paddy Model ( 10/ 29/ 2002)

Fletcher, J. S., J. E. Nellesson and T. G. Pfleeger. 1994. Literature review and evaluation of the EPA food chain ( Kenaga) nomogram, an instrument for estimating pesticide residues on plants. Environ. Tox. And Chem. 13( 9): 1383 1391.

Hazardous Substances Data Bank monograph for MGK 264. National Library of Medicine. ( toxnet. nlm. nih. gov)

Hoerger, F. D. and E. E. Kenaga. 1972. Pesticide residues on plants: Correlation of representative data as a basis for estimation of their magnitude in the environment. in, Environmental Quality. F. Coulston and F. Korte, Eds. Academic Press, New York. Vol. I, pp. 9 28.

Master Label for MGK 264 ( 4/ 21/ 2003), 30 pp.

MPBPWIN v1.40 program in EPISuite program. Syracuse Research Corporation ( http:// www. epa. gov/ oppt/ exposure/ docs/ episuitedl. htm)

Sahay, N. and R. A. Agarwal, 1997, Chemosphere, Vol. 35, No. 5, pp. 1011 1021.

Syracuse Research Corporation ( SRC) PhysProp Database. ( http:// www. syrres. com/ esc/ physprop. htm)

United States Environmental Protection Agency ( USEPA). 2005. User's Guide, T REX Version 1.2.3 ( Terrestrial Residue Exposure Model). Environmental Fate and Effects Division, Office of Pesticides Program. August 8.

Use Closure Memo, 11/ 17/ 03. C. Rodia, USEPA Office of Pesticide Programs, Special Review and Reregistration Division. 21 APPENDICES Appendix A: Summary of Subdivision N Fate Guideline Studies i. Degradation Hydrolysis ( 161 1)

N Octyl bicycloheptene dicarboximide was stable to hydrolysis in pH 5, 7, and 9 aqueous buffer solutions that were incubated in darkness at 25 oC for 30 days. MRID 42222601 Photolysis in Water ( 161 2)

N Octyl bicycloheptene dicarboximide was stable in aqueous buffered pH 7 solutions that were continuously irradiated with a xenon arc lamp at 25 oC for 30 days. MRID 42222602 Photodegradation on Soil ( 161 3)

MGK 264 [ N( 2 ethylhexyl 5 norbornene 2,3 dicarboximide)] photodegraded slowly, declining from 98.39 to 80.14% of the applied on sandy loam soil during 31 days ( 737 hours) of irradiation using a xenon lamp at 26 oC. The spectral irradiance and intensity of the xenon lamp was similar to sunlight at wavelengths between 290 and 750 nm. In the dark control during the same period, MGK 264 declined from an average 98.39 to 86.13% of the applied. No degradates were recovered from either the irradiated or dark control soils at > 1% of the applied. MRID 42807501 Aerobic Soil Metabolism ( 162 1)

MGK 264 [ N( 2 ethylhexyl 5 norbornene 2,3 dicarboximide)] degraded with a calculated half life of 388 days in sandy loam soil that was treated at 8.7 9.6 µ g/ g with MGK 264 and incubated in darkness at 25 oC and 70 75% of field moisture capacity for 365 days. Eight degradates, each at maximums of 1.1 15.3% of the applied ( 0.09 1.46 µ g/ g), were isolated from the soil but were not identified. At 365 days posttreatment, uncharacterized volatile residues totaled 7 12% of the applied ( 0.6 1.2 µ g/ g), and CO2 totaled 0.3 0.7% ( 0.03 0.07 µ g/ g). MRID 43194501 Anaerobic Soil Metabolism ( 162 2)

MGK 264 [ N( 2 ethylhexyl 5 norbornene 2,3 dicarboximide)] declined from 8.05 to 6.91 µ g/ g during 60 days of anaerobic ( flooded plus nitrogen atmosphere) incubation in sandy loam soil that was treated with MGK 264 at 9 10 µ g/ g and incubated under anaerobic conditions in darkness at 25 oC for 60 days following 30 days of aerobic incubation. Four degradates, each at maximums of 0.40 8.6% of the applied ( 0.04 0.88 µ g/ g), were isolated from the floodwater and soil but were not identified. At 90 days posttreatment, uncharacterized volatile residues collected in ethylene glycol trapping solutions totaled 3.7 5.2% of the applied ( 0.3 0.5 µ g/ g), and CO2 totaled < 0.01%. MRID 43194502 Anaerobic Aquatic Metabolism ( 162 3)

Waived 2/ 4/ 1994.

Aerobic Aquatic Metabolism ( 162 4)

Waived 2/ 4/ 1994.

Terrestrial Field Dissipation ( 164 1)

Waiver requested ( date).

Long Term Soil Dissipation ( 164 5)

Waived 2/ 4/ 1994. 22 ii. Mobility Leaching and Adsorption/ Desorption ( 163 1)

MGK 264 was very mobile to moderately mobile in sand and sandy loam soils and relatively immobile in silt loam and clay loam soils. Freundlich Kads values were 1.6 for the Tiffany sand soil ( 0.5 % OM), 2.7 for the San Joaquin sandy loam ( 0.5 % OM), 5.4 for the Anthony sandy loam soil ( 0.7 % OM), 20 for the Dundee clay loam soil ( 1.3 % OM), and 33 for the Gardena silt loam soil ( 4.2 % OM). Adsorption increased with increasing soil organic matter content. Freundlich Kdes values ranged from 9.1 to 10.2 for the above soils. Kocads values were 636 for Tiffany sand, 899 for San Joaquin sandy loam, 1,555 for Anthony sandy loam, 1,588 for Gardena silt loam, and 3,106 for Dundee clay loam soil. Kocdes values were 4,099 for Tiffany sand, 3,049 for San Joaquin sandy loam, 2,797 for Anthony sandy loam, 441 for Gardena silt loam, and 1,419 for Dundee clay loam soil. MRID 42622501 Aged Leaching Adsorption Desorption ( 163 1)

Reserved.

Fish Bioaccumulation ( 165 4)

Waived 2/ 4/ 1994. 23 Appendix B. Summary of Ecotoxicity Data 1. Ecological Toxicity Data a. Toxicity to Terrestrial Animals i. Birds, Acute and Subacute An acute oral toxicity study using the technical grade of the active ingredient ( TGAI) is required to establish the toxicity of MGK 264 to birds. The preferred test species is either mallard duck ( a waterfowl) or bobwhite quail ( an upland gamebird). The registrant submitted one study of each ( MRID 418215 01, 418215 02) and because both satisfied guideline testing requirements, the guideline 71 1 requirement is fulfilled. Results of these tests are tabulated below.

Avian Acute Oral Toxicity Species % ai LD50 ( mg/ kg bw) Toxicity Category MRID No. Author/ Year Study classification ( 1)

Northern bobwhite quail ( Colinus virginianus) 93.1 > 2250 ( no mortality at any treatment level) Practically nontoxic 418215 01 Campbell 1991 Acceptable Mallard duck ( Anas platyrhynchos) 92.9 > 2250 ( no mortality at any treatment level) Practically nontoxic 418215 02 Campbell 1991 Acceptable ( 1) Acceptable ( study satisfies guideline). Supplemental ( study is scientifically sound, but does not satisfy guideline)

Since the acute oral LD50 values are greater than 2250 mg/ kg bw, MGK 264 is classified as practically non toxic to avian species on an acute oral basis.

Two subacute dietary studies using the TGAI are required to establish the toxicity of MGK 264 to birds. The preferred test species are mallard duck and bobwhite quail. The registrant submitted one study of each ( MRID 416873 01, 416873 02) and because both satisfied guideline testing requirements, the guideline 71 2 requirement is fulfilled. Results of these tests are tabulated below.

Avian Subacute Dietary Toxicity Species % ai 5 Day LC50 ( ppm) ( 1) Toxicity Category MRID No. Author/ Year Study Classification ( 2)

Northern bobwhite quail ( Colinus virginianus) 92.9 > 5620 ( no mortality at any treatment level) Practically nontoxic 416873 01 Campbell 1990 Acceptable Mallard duck ( Anas platyrhynchos) 92.9 > 5620 ( no mortality at any treatment level) Practically nontoxic 416873 02 Campbell 1990 Acceptable 1) Test organisms observed an additional three days while on untreated feed. ( 2) Acceptable ( study satisfies guideline). Supplemental ( study is scientifically sound, but does not satisfy guideline)

Since the 5 day LC50 values are greater than 5620 ppm, MGK 264 is classified as practically non toxic to avian species on a subacute dietary basis. 24 ii. Birds, Chronic Because MGK 264 is relatively persistent and timing of use may coincide with all portions or some portions of reproduction in birds reproductive testing in at least one bird species is required. No study was submitted by the registrant and none were found in ECOTOX.

iii. Mammals, Acute and Chronic Wild mammal testing is required on a case by case basis, depending on the results of lower tier laboratory mammalian studies, intended use pattern and pertinent environmental fate characteristics. In most cases, rat, mouse, rabbit, or dog toxicity values obtained from the Agency's Health Effects Division ( HED) substitute for wild mammal testing. Toxicity studies submitted to HED and their values are reported below.

Mammalian Toxicity Species/ Study Duration % ai Test type Toxicity value Affected endpoints MRID No.

laboratory rat ( Rattus norvegicus) Formulated product ( mixed ai) Acute oral LD50 > 20 g/ kg Mortality 417523 05 Laboratory rat ( Rattus norvegicus) Multiple generation reproduction study NOEL < 62.5 mg/ kg body weight Pup weight gain 421557 01 The results indicate that MGK 264 is classified as Toxicity Category IV chemical to small mammals on an acute oral basis. Examination of HED's DER on the rat multiple generation reproductive study ( MRID 41752305 ) provides details on MGK 264 dietary effects on F1 and F2 reproductive, offspring survival, and pup body weight parameters. These are summarized below.

Reproductive Effects in Laboratory Rats from Chronic Dietary Exposure to MGK 264 PARAMETER SIGNIFICANT DIETARY LEVEL F1 F2 Reproductive Parameter No. mating ( F0) Fertility index Pregnancy index Gestation index Gestation length ( day) No effect No effect Offspring Survival Total no. live pups No effect Mean no. live pups/ litter No effect Mean no. dead pups/ litter   2500 ppm Live birth index (%) 10000 ( highest dose) Viability index (%) No effect Lactate index (%) No effect No effect Mean pup body weight ( g)   1250 ppm ( lowest dose)   1250 ppm Although the mean number of dead pups per litter was significantly different from the control at   2500 ppm, there is no dose response relationship established ( there was no effect for 25 the highest dose of 10,000 ppm). For the live birth index (%) parameter with the highest dosage, the effect is significantly different from the second control, but it was within the error term ( i. e., less than the difference between the two controls). The only parameter showing constant significant effects in both the F1 and F2 generations was the mean pup body weight parameter.

iv. Insects A honey bee acute contact study using the TGAI is required for MGK 264 because its use ( lawn/ turf/ ornamental plants) will result in honey bee exposure. No study was submitted.

b. Toxicity to Freshwater Aquatic Animals i. Freshwater Fish, Acute Two freshwater fish toxicity studies, one with a warmwater and one with a coldwater species, using the TGAI are required to establish the toxicity of MGK 264 to fish. The preferred test species are rainbow trout ( a coldwater fish) and bluegill sunfish ( a warmwater fish). The registrant submitted one study of each ( MRID 419115 01, 418197 01) and because both satisfied guideline testing requirements, the guideline 72 1 requirement is fulfilled Results of these tests are tabulated below. Since the 96 h LC50 values fall in the range of 1.4 to 2.4 ppm, MGK 264 is classified as moderately toxic to freshwater fish on an acute basis.

Freshwater Fish Acute Toxicity Species/ ( Flow through or Static) % ai 96 hour LC50 ( ppm)) Toxicity category MRID No. Author/ Year Study Classification( 1)

Rainbow trout ( Oncorhynchus mykiss static 92.9 1.4 Moderately toxic 419115 01 Bowman 1991 Acceptable Bluegill sunfish ( Lepomis macrochirus) 92.9 2.4 Moderately toxic 418197 01 Bowman 1991 Acceptable ( 1) Acceptable ( study satisfies guideline). Supplemental ( study is scientifically sound, but does not satisfy guideline)

Since the LC50 falls in the range of 1.4 to 2.4 ppm, MGK 264 is moderately toxic to freshwater fish on an acute basis. The guideline ( 72 1) is fulfilled ( MRID 419115 01, 418197 01).

ii. Freshwater Fish, Chronic No study was submitted and none were found in ECOTOX.

iii. Freshwater Invertebrates, Acute A freshwater aquatic invertebrate toxicity test using the TGAI is required to establish the toxicity of MGK 264 to aquatic invertebrates. The preferred test species is Daphnia magna. Results of this test are tabulated below.

Freshwater Invertebrate Toxicity Species/( Static or Flow through) % ai 48 hour LC50/ EC50 ( ppm) ( measured/ nomin al) Toxicity Category MRID No. Author/ Year Study Classification 26 Waterflea ( Daphnia magna) 92.9 2.3 Moderately toxic 415261 02 Bowman/ Bir gess 1991 core Since theEC50 is 2.3 ppm, MGK 264 is moderately toxic to aquatic invertebrates on an acute basis. The guideline ( 72 2) is fulfilled ( MRID 415261 02 ).

c. Toxicity to Estuarine and Marine Animals No study was submitted. 27 Appendix C. TREX output for twenty ( 20) applications Acute and Chronic RQs are based on the Upper Bound Upper Bound Kenaga Residues For RQ Calculation Kenaga Residues.

Chemical Name: MGK 264 The maximum single day residue estimation is used for Use Ornamentals and lawns both the acute and reproduction RQs.

Formulation 0 Application Rate 0.3 lbs a. i./ acre RQs reported as " 0.00" in the RQ tables below should be noted as Half life 35 days < 0.01 in your assessment. This is due to rounding and significant Application Interval 7 days figure issues in Excel.

Maximum # Apps./ Year 20 Length of Simulation 1 year Endpoints Bobwhite quail LD50 ( mg/ kgbw 2250.00 Bobwhite quail LC50 ( mg/ kgdiet 5620.00 0 NOAEL( m g/ kg bw) 0.00 Avian Bobwhite quail NOAEC ( mg/ kgdiet 0.00 LD50 ( mg/ kg bw) 20000.00 LC50 ( mg/ kg diet) 0.00 NOAEL ( mg/ kg bw) 62.50 Mammals NOAEC ( mg/ kg diet) 1250.00 Kenaga Dietary based EECs ( ppm) Values Short Grass 521.44 Tall Grass 238.99 Broadleaf plants/ sm Insects 293.31 Fruits/ pods/ seeds/ lg insects 32.59 Avian Results Avian Body Ingestion ( Fdry) Ingestion ( Fwet) % body wgt FI Class Weight ( g) ( g bw/ day) ( g/ day) consum ed ( kgdiet day)

Small 20 5 23 114 2.28E 02 Mid 100 13 65 65 6.49E 02 Large 1000 58 291 29 2.91E 01 28 Avian Body Adjusted LD50 Weight ( g) ( mg/ kgbw 20 1620.97 100 2063.57 1000 2914.87 Avian Classes and Body Weights small mid large Dose based EECs ( mg/ kg bw)

20 g 100 g 1000 g Short Grass 593.87 338.65 151.62 Tall Grass 272.19 155.21 69.49 Broadleaf plants/ sm Insects 334.05 190.49 85.28 Fruits/ pods/ seeds/ lg insects 37.12 21.17 9.48 Avian Acute RQs Dose based RQs ( Dose based EEC/ adjusted LD50) 20 g 100 g 1000 g Short Grass 0.37 0.16 0.05 Tall Grass 0.17 0.08 0.02 Broadleaf plants/ sm insects 0.21 0.09 0.03 Fruits/ pods/ seeds/ lg insects 0.02 0.01 0.00 RQs Dietary based RQs ( Dietary based EEC/ LC50 or NOAEC)

Acute Chronic Short Grass 0.09 # DIV/ 0!

Tall Grass 0.04 # DIV/ 0!

Broadleaf plants/ sm Insects 0.05 # DIV/ 0!

Fruits/ pods/ seeds/ lg insects 0.01 # DIV/ 0!

Note: To provide risk management with the maximum possible information, it is recommended that both the dosebased and concentration based RQs be calculated when data are available MGK 264 Ornamental s and lawns Upper bound Kenaga Residues Mammalian Results Mammalian Body Ingestion ( Fdry) Ingestion ( Fwet) % body wgt FI 29 Class Weight ( g bwt/ day) ( g/ day) consum ed ( kgdiet day)

15 3 14 95 1.43E 02 Herbivores/ 35 5 23 66 2.31E 02 insectivores 1000 31 153 15 1.53E 01 15 3 3 21 3.18E 03 Grainvores 35 5 5 15 5.13E 03 1000 31 34 3 3.40E 02 Mammalian Body Adjusted Adjusted Class Weight LD50 NOAEL 15 43956.61 137.36 Herbivores/ 35 35565.59 111.14 insectivores 1000 15383.21 48.07 15 43956.61 137.36 Grainvores 35 35565.59 111.14 1000 15383.21 48.07 Mammalian Classes and Body weight Herbivores/ insectivores Granivores Dose Based EECs ( mg/ kg bw) 15 g 35 g 1000 g 15 g 35 g 1000 g Short Grass 497.15 343.60 79.66 Tall Grass 227.86 157.48 36.51 Broadleaf plants/ sm Insects 279.65 193.27 44.81 Fruits/ pods/ seeds/ lg insects 31.07 21.47 4.98 6.90 4.77 1.11 15 g mammal 35 g mammal 1000 g mammal Dose based RQs ( Dose based EEC/ LD50 or NOAEL)

Acute Chronic Acute Chronic Acute Chronic Short Grass 0.01 3.62 0.01 3.09 0.01 1.66 Tall Grass 0.01 1.66 0.00 1.42 0.00 0.76 Broadleaf plants/ sm insects 0.01 2.04 0.01 1.74 0.00 0.93 Fruits/ pods/ lg insects 0.00 0.23 0.00 0.19 0.00 0.10 Seeds ( granivore) 0.00 0.05 0.00 0.04 0.00 0.02 Mammal RQs Dietary based RQs ( Dietary based EEC/ LC50 or NOAEC)

Acute Chronic Short Grass # DIV/ 0! 0.42 Tall Grass # DIV/ 0! 0.19 Broadleaf plants/ sm insects # DIV/ 0! 0.23 Fruits/ pods/ seeds/ lg insects # DIV/ 0! 0.03 Note: To provide risk management with the maximum possible information, it is recommended that both the dosebased and concentration based RQs be calculated when data are available 30 MGK 264 Ornamental s and lawns Upper bound Kenaga Residues Terrestrial Residues Graph 31 32 Appendix D: PRZM EXAMS Oput for twenty ( 20) applications 1. Florida Turf stored as 03lb20x. out Chemical: MGK 264 PRZM environment: FLturfC. txt modified Monday, 16 June 2003 at 13: 48: 06 EXAMS environment: pond298. exv modified Thuday, 29 August 2002 at 16: 33: 30 Metfile: w12834. dvf modified Wedday, 3 July 2002 at 09: 04: 28 Water segment concentrations ( ppb)

Year Peak 96 hr 21 Day60 Day90 DayYearly 1961 21.46 20.91 19.06 16.79 15.71 7.213 1962 29.09 28.51 27.4 26.1 26.17 18.77 1963 46.53 45.66 43.11 40.6 38.92 30.21 1964 62.82 61.99 59.31 55.86 54.63 43.12 1965 57.99 57.42 55.55 53.09 51.83 47.62 1966 77.33 76.22 72.08 70.07 68.1 54.71 1967 66.26 65.68 64.76 62.17 62.08 57.12 1968 76.6 76.18 74.18 71.31 70.44 62.48 1969 84.03 83.18 81.19 77.26 76.13 66.54 1970 70.19 70.12 69.64 68.65 67.94 62.84 1971 66.79 66.31 65.17 64.19 63.54 59.4 1972 81.22 80.3 77.01 72.27 71.63 62.92 1973 68.15 67.99 67.42 66.33 65.55 63.27 1974 69.34 68.89 67.25 66.49 65.56 60.28 1975 60.4 60.13 59.77 59.02 58.43 56.85 1976 66.91 66.27 64.22 61.17 59.73 56.41 1977 70.79 70.14 68.22 65.89 64.41 57.9 1978 66.84 66.35 64.61 62.51 62.13 58.73 1979 73.28 72.59 71.32 69.32 69.13 61.69 1980 63.01 62.93 62.64 61.96 61.38 58.85 1981 70.39 69.66 67.38 64.46 62.63 55.48 1982 69.17 68.54 66.95 66.1 65.39 59.29 1983 69.67 69.25 67.8 67.02 66.68 60.81 1984 70.75 70.2 68.51 67.17 66.27 63.4 1985 63.69 63.38 62.56 61.74 61.14 59.98 1986 75.21 74.43 72.79 68.79 67.05 59.35 1987 59.21 59.14 58.87 58.35 57.89 55.36 1988 53.39 53.12 52.18 51.24 50.83 49.68 1989 69.66 68.77 66.32 61.58 58.71 50.84 1990 54.7 54.57 54.08 53.17 52.64 50.57 Sorted results Prob. Peak 96 hr 21 Day 60 Day 90 Day Yearly 0.032258064516129 84.03 83.18 81.19 77.26 76.13 66.54 0.0645161290322581 81.22 80.3 77.01 72.27 71.63 63.4 0.0967741935483871 77.33 76.22 74.18 71.31 70.44 63.27 0.129032258064516 76.6 76.18 72.79 70.07 69.13 62.92 0.161290322580645 75.21 74.43 72.08 69.32 68.1 62.84 0.193548387096774 73.28 72.59 71.32 68.79 67.94 62.48 0.225806451612903 70.79 70.2 69.64 68.65 67.05 61.69 0.258064516129032 70.75 70.14 68.51 67.17 66.68 60.81 0.290322580645161 70.39 70.12 68.22 67.02 66.27 60.28 0.32258064516129 70.19 69.66 67.8 66.49 65.56 59.98 0.354838709677419 69.67 69.25 67.42 66.33 65.55 59.4 0.387096774193548 69.66 68.89 67.38 66.1 65.39 59.35 0.419354838709677 69.34 68.77 67.25 65.89 64.41 59.29 0.451612903225806 69.17 68.54 66.95 64.46 63.54 58.85 0.483870967741936 68.15 67.99 66.32 64.19 62.63 58.73 0.516129032258065 66.91 66.35 65.17 62.51 62.13 57.9 0.548387096774194 66.84 66.31 64.76 62.17 62.08 57.12 0.580645161290323 66.79 66.27 64.61 61.96 61.38 56.85 0.612903225806452 66.26 65.68 64.22 61.74 61.14 56.41 0.645161290322581 63.69 63.38 62.64 61.58 59.73 55.48 0.67741935483871 63.01 62.93 62.56 61.17 58.71 55.36 0.709677419354839 62.82 61.99 59.77 59.02 58.43 54.71 0.741935483870968 60.4 60.13 59.31 58.35 57.89 50.84 33 0.774193548387097 59.21 59.14 58.87 55.86 54.63 50.57 0.806451612903226 57.99 57.42 55.55 53.17 52.64 49.68 0.838709677419355 54.7 54.57 54.08 53.09 51.83 47.62 0.870967741935484 53.39 53.12 52.18 51.24 50.83 43.12 0.903225806451613 46.53 45.66 43.11 40.6 38.92 30.21 0.935483870967742 29.09 28.51 27.4 26.1 26.17 18.77 0.967741935483871 21.46 20.91 19.06 16.79 15.71 7.213 0.1 77.257 76.216 74.041 71.186 70.309 63.235 Average of yearly averages: 53.7227666666667 Inputs generated by pe4. pl  8 August 2003 Data used for this run: Output File: 03lb20x Metfile: w12834. dvf PRZM scenario: FLturfC. txt EXAMS environment file: pond298. exv Chemical Name: MGK 264 Description Variable Name Value Units Comments Molecular weight mwt 275.39 g/ mol Henry's Law Const. henry 2.85e 7 atm m^ 3/ mol Vapor Pressure vapr 1.8e 5 torr Solubility sol 150 mg/ L Kd Kd mg/ L Koc Koc 899 mg/ L Photolysis half life kdp 0 days Half life Aerobic Aquatic Metabolism kbacw 860 days Halfife Anaerobic Aquatic Metabolism kbacs 0 days Halfife Aerobic Soil Metabolism asm 430 days Halfife Hydrolysis: pH 5 0 days Half life Hydrolysis: pH 7 0 days Half life Hydrolysis: pH 9 0 days Half life Method: CAM 2 integer See PRZM manual Incorporation Depth: DEPI 0 cm Application Rate: TAPP 0.336 kg/ ha Application Efficiency: APPEFF 0.99 fraction Spray Drift DRFT 0.01 fraction of application rate applied to pond Application Date Date 01 04 dd/ mm or dd/ mmm or dd mm or dd mmm Interval 1 interval 7 days Set to 0 or delete line for single app. Interval 2 interval 7 days Set to 0 or delete line for single app. Interval 3 interval 7 days Set to 0 or delete line for single app. Interval 4 interval 7 days Set to 0 or delete line for single app. Interval 5 interval 7 days Set to 0 or delete line for single app. Interval 6 interval 7 days Set to 0 or delete line for single app. Interval 7 interval 7 days Set to 0 or delete line for single app. Interval 8 interval 7 days Set to 0 or delete line for single app. Interval 9 interval 7 days Set to 0 or delete line for single app. Interval 10 interval 7 days Set to 0 or delete line for single app. Interval 11 interval 7 days Set to 0 or delete line for single app. Interval 12 interval 7 days Set to 0 or delete line for single app. Interval 13 interval 7 days Set to 0 or delete line for single app. Interval 14 interval 7 days Set to 0 or delete line for single app. Interval 15 interval 7 days Set to 0 or delete line for single app. Interval 16 interval 7 days Set to 0 or delete line for single app. Interval 17 interval 7 days Set to 0 or delete line for single app. Interval 18 interval 7 days Set to 0 or delete line for single app. Interval 19 interval 7 days Set to 0 or delete line for single app. Record 17: FILTRA IPSCND 1 UPTKF 0 Record 18: PLVKRT 0 PLDKRT 0 FEXTRC 0.5 Flag for Index Res. Run IR Pond Flag for runoff calc. RUNOFF none none, monthly or total( average of entire run) 34 2. Pennsylvania Turf stored as 03lb20x. out Chemical: MGK 264 PRZM environment: PAturfC. txt modified Satday, 12 October 2002 at 16: 27: 02 EXAMS environment: pond298. exv modified Thuday, 29 August 2002 at 16: 33: 30 Metfile: w14737. dvf modified Wedday, 3 July 2002 at 09: 06: 12 Water segment concentrations ( ppb)

Year Peak 96 hr 21 Day60 Day90 DayYearly 1961 15.52 15.05 13.63 11.94 10.94 4.887 1962 16.56 16.43 15.87 14.88 14.44 11.81 1963 23.91 23.54 22.76 21.58 21.43 16.14 1964 21.42 21.33 20.86 20.53 20.46 20.19 1965 22.42 22.37 22.13 21.59 21.46 21.1 1966 27.32 27.07 26.67 25.65 25.17 22.29 1967 35.66 35.19 34.38 33.13 32.46 27.77 1968 35.19 34.92 34.15 33 32.45 30.31 1969 52.88 52.1 49.3 44.99 43.07 34.24 1970 39.94 39.76 39.25 38.9 38.41 37.64 1971 54.82 54.19 52.66 50.69 49.71 41.96 1972 62.81 62.17 59.82 57.72 56.32 50.64 1973 64.88 64.4 62.56 59.96 59.6 56.18 1974 63.4 62.99 61.71 60.28 59.35 56.78 1975 57.95 57.65 56.57 55.65 54.88 53.9 1976 64.81 64.34 62.17 60.3 59.76 53.56 1977 56.35 56.34 56.29 56.22 55.93 53.3 1978 64.24 63.63 61.54 58.65 57.31 52.41 1979 62.41 61.97 60.56 58.67 57.7 53.93 1980 54.25 54.25 54.24 54.16 53.9 51 1981 49.13 49 48.94 48.76 48.32 46.35 1982 69.66 68.78 65.72 61.3 59.25 49.93 1983 52.78 52.78 52.64 52.29 51.77 50.29 1984 57.58 57.27 56.41 55.13 54.84 50.95 1985 72.95 72.05 68.98 64.88 63.42 53.26 1986 59.87 59.83 59.7 59.52 59.1 56.47 1987 77.36 76.44 73.36 68.81 66.67 56.78 1988 66.58 66.31 65.04 62.97 62.85 60.81 1989 62.34 62.04 61.03 59.84 59.32 58.74 1990 70.49 69.85 67.72 64.51 63.07 58.4 Sorted results Prob. Peak 96 hr 21 Day 60 Day 90 Day Yearly 0.032258064516129 77.36 76.44 73.36 68.81 66.67 60.81 0.0645161290322581 72.95 72.05 68.98 64.88 63.42 58.74 0.0967741935483871 70.49 69.85 67.72 64.51 63.07 58.4 0.129032258064516 69.66 68.78 65.72 62.97 62.85 56.78 0.161290322580645 66.58 66.31 65.04 61.3 59.76 56.78 0.193548387096774 64.88 64.4 62.56 60.3 59.6 56.47 0.225806451612903 64.81 64.34 62.17 60.28 59.35 56.18 0.258064516129032 64.24 63.63 61.71 59.96 59.32 53.93 0.290322580645161 63.4 62.99 61.54 59.84 59.25 53.9 0.32258064516129 62.81 62.17 61.03 59.52 59.1 53.56 0.354838709677419 62.41 62.04 60.56 58.67 57.7 53.3 0.387096774193548 62.34 61.97 59.82 58.65 57.31 53.26 0.419354838709677 59.87 59.83 59.7 57.72 56.32 52.41 0.451612903225806 57.95 57.65 56.57 56.22 55.93 51 0.483870967741936 57.58 57.27 56.41 55.65 54.88 50.95 0.516129032258065 56.35 56.34 56.29 55.13 54.84 50.64 0.548387096774194 54.82 54.25 54.24 54.16 53.9 50.29 0.580645161290323 54.25 54.19 52.66 52.29 51.77 49.93 0.612903225806452 52.88 52.78 52.64 50.69 49.71 46.35 0.645161290322581 52.78 52.1 49.3 48.76 48.32 41.96 0.67741935483871 49.13 49 48.94 44.99 43.07 37.64 0.709677419354839 39.94 39.76 39.25 38.9 38.41 34.24 0.741935483870968 35.66 35.19 34.38 33.13 32.46 30.31 0.774193548387097 35.19 34.92 34.15 33 32.45 27.77 0.806451612903226 27.32 27.07 26.67 25.65 25.17 22.29 0.838709677419355 23.91 23.54 22.76 21.59 21.46 21.1 35 0.870967741935484 22.42 22.37 22.13 21.58 21.43 20.19 0.903225806451613 21.42 21.33 20.86 20.53 20.46 16.14 0.935483870967742 16.56 16.43 15.87 14.88 14.44 11.81 0.967741935483871 15.52 15.05 13.63 11.94 10.94 4.887 0.1 70.407 69.743 67.52 64.356 63.048 58.238 Average of yearly averages: 43.0672333333333 Inputs generated by pe4. pl  8 August 2003 Data used for this run: Output File: 03lb20x Metfile: w14737. dvf PRZM scenario: PAturfC. txt EXAMS environment file: pond298. exv Chemical Name: MGK 264 Description Variable Name Value Units Comments Molecular weight mwt 275.39 g/ mol Henry's Law Const. henry 2.85e 7 atm m^ 3/ mol Vapor Pressure vapr 1.8e 5 torr Solubility sol 150 mg/ L Kd Kd mg/ L Koc Koc 899 mg/ L Photolysis half life kdp 0 days Half life Aerobic Aquatic Metabolism kbacw 860 days Halfife Anaerobic Aquatic Metabolism kbacs 0 days Halfife Aerobic Soil Metabolism asm 430 days Halfife Hydrolysis: pH 5 0 days Half life Hydrolysis: pH 7 0 days Half life Hydrolysis: pH 9 0 days Half life Method: CAM 2 integer See PRZM manual Incorporation Depth: DEPI 0 cm Application Rate: TAPP 0.336 kg/ ha Application Efficiency: APPEFF 0.99 fraction Spray Drift DRFT 0.01 fraction of application rate applied to pond Application Date Date 01 04 dd/ mm or dd/ mmm or dd mm or dd mmm Interval 1 interval 7 days Set to 0 or delete line for single app. Interval 2 interval 7 days Set to 0 or delete line for single app. Interval 3 interval 7 days Set to 0 or delete line for single app. Interval 4 interval 7 days Set to 0 or delete line for single app. Interval 5 interval 7 days Set to 0 or delete line for single app. Interval 6 interval 7 days Set to 0 or delete line for single app. Interval 7 interval 7 days Set to 0 or delete line for single app. Interval 8 interval 7 days Set to 0 or delete line for single app. Interval 9 interval 7 days Set to 0 or delete line for single app. Interval 10 interval 7 days Set to 0 or delete line for single app. Interval 11 interval 7 days Set to 0 or delete line for single app. Interval 12 interval 7 days Set to 0 or delete line for single app. Interval 13 interval 7 days Set to 0 or delete line for single app. Interval 14 interval 7 days Set to 0 or delete line for single app. Interval 15 interval 7 days Set to 0 or delete line for single app. Interval 16 interval 7 days Set to 0 or delete line for single app. Interval 17 interval 7 days Set to 0 or delete line for single app. Interval 18 interval 7 days Set to 0 or delete line for single app. Interval 19 interval 7 days Set to 0 or delete line for single app. Record 17: FILTRA IPSCND 1 UPTKF 0 Record 18: PLVKRT 0 PLDKRT 0 FEXTRC 0.5 Flag for Index Res. Run IR Pond Flag for runoff calc. RUNOFF none none, monthly or total( average of entire run) 36 Appendix E: Environmental Fate and Ecological Effects Data Requirements for MGK 264 Guideline # Data Requirement Is Data requirement satisfied? MRID No. Study Classification 161 1 835.2120 Hydrolysis Yes 42222601 Acceptable 161 2 835.2240 Photodegradation in water Yes 42222602 Acceptable 161 3 835.2410 Photodegradation on soil Yes 42807501 Acceptable 161 4 835.2370 Photodegradation in air    162 1 835.4100 Aerobic soil metabolism Yes 43194501 Supplemental, upgradeable 162 2 835.4200 Anaerobic soil metabolism Yes 43194502 Acceptable 162 3 835.4400 Anaerobic aquatic metabolism Waived 02/ 04/ 1994   162 4 835.4300 Aerobic aquatic metabolism Waived 02/ 04/ 1994   163 1 835.1240835.12 30 Leaching adsorption/ desorption Yes 42622501 Acceptable ( unaged portion) 163 2 835.1410 Laboratory volatility    163 3 835.8100 Field volatility    164 1 835.6100 Terrestrial field dissipation    164 2 835.6200 Aquatic field dissipation    164 3 835.6300 Forestry dissipation    164 4 835.6400 Combination products and tank mixtures dissipation

165 4 850.1730 Accumulation in fish Requested   165 5 850.1950 Accumulation aquatic nontarget    166 1 835.7100 Ground water   small prospective    201 1 840.1100 Droplet size spectrum    202 1 840.1200 Drift field evaluation

Table A2. Status of ecological effect data needs for MGK 264 Guideline # Data requirement Are data adequate for risk assessment? MRID No. Study classification 71 1a Bobwhite quail acute oral DR NS  71 1b Mallard duck acute oral ND NS  71 2a Bobwhite quail subacute dietary Yes 41687301 Core 71 2b Mallard duck subacute dietary Yes 41687302 Core 71 3 Wild mammal toxicity ND NS  71 4a Bobwhite quail reproduction DR NS  71 4b Mallard duck reproduction ND NS  71 5a Simulated terrestrial field study ND NS  71 5b Actual terrestrial field study ND NS  72 1a Freshwater fish ( bluegill sunfish0 acute Yes 41819701 core 72 1b Freshwater fish acute ND NS  72 1c Freshwater fish ( rainbow trout) acute Yes 42202201 Core 72 1d Freshwater fish ( acute) ND NS  72 2a Freshwater invertebrate ( wateflea) acute yes 41526101 core 72 2b Freshwater invertebrate ( wateflea) acute ND NS  72 3a Estuarine/ marine fish ( sheepshead minnow) acute DR NS

72 3b Estuarine/ marine invertebrate ( eastern oyster) acute DR NS

72 3c Estuarine/ marine invertebrate ( mysid shrimp) acute DR NS

72 4a Freshwater fish early life stage ( fathead minnow) DR NS

72 4b Freshwater invertebrate life cycle ( waterflea) ND NS

72 4c Estuarine/ marine invertebrate life cycle ( mysid shrimp) ND NS

72 4 Estuarine/ marine fish early life stage ND NS  37 72 5 Freshwater fish life cycle ND NS  72 6 Aquatic organism accumulation ND NS  72 7a Simulated aquatic field study ND NS  72 7b Actual aquatic field study ND NS  122 1a Seed germination/ seedling emergence ( tier 1) ND NS

122 1b Vegetative vigor ( tier 1) ND NS  122 2 Aquatic plant growth ( tier 1) ND NS  122 2 Aquatic plant algal growth 9tier 1) ND NS  123 1a Seed germination/ seedling emergence ( tier 2) ND NS

123 1b Vegetative vigor ( tier 2) ND NS  123 2 Aquatic plant growth ( tier 2) ND NS  124 1 Terrestrial field study ND NS  124 2 Aquatic field study ND NS  141 1 Honey bee acute contact ND NS  141 2 Honey bee residue on foliage ND NS  141 5 Field test for pollinatoris ND NS  DR = Data required; ND = No data to evaluate; NS = No data submitted. 38 APPENDIX F Toxicity Data Toxicity testing reported in this section does not represent all species of bird, mammal, or aquatic organism. Only two surrogate species for both freshwater fish and birds are used to represent all freshwater fish ( 2000+) and bird ( 680+) species in the United States. For mammals, acute studies are usually limited to Norway rat or the house mouse. Estuarine/ marine testing is usually limited to a crustacean, a mollusk, and a fish. Also, neither reptiles nor amphibians are tested. The assessment of risk or hazard makes the assumption that avian and reptilian toxicity are similar. The same assumption is used for fish and amphibians.

Ecological Effects Characterization Risk assessment of a pesticide's ecological effects integrates the results of exposure and toxicity data to evaluate the likelihood of adverse ecological effects on a non target species. The means of integrating these exposure factors is the risk quotient ( RQ) method. Risk quotients are calculated by dividing estimated environmental concentrations ( EECs) of the pesticide by acute and chronic toxicity values. EECs are based on the maximum application rates for that pesticide.

Risk quotients are then compared to the Agency's levels of concern ( LOCs). These LOCs are used to analyze potential risk to non target organisms and the need to consider regulatory action. The criteria are used to indicate when a pesticide used as directed has the potential to cause adverse effects on non target organisms. LOCs currently address the following risk presumption categories: ( 1) acute high: high potential for acute risk for all nontarget organisms which may warrant regulatory action in addition to restricted use classification; ( 2) acute restricted use: potential for acute risk for all nontarget organisms, but may be mitigated through restricted use classification; ( 3) acute endangered species: endangered species may be adversely affected by use; and ( 4) chronic risk: potential for chronic risk may warrant regulatory action. Currently, the Agency does not perform assessments for chronic risk to plants, acute chronic risks to non target insects, or chronic risk from granular/ bait formulations to birds or mammals. In addition, the Agency considers any incident data that is submitted concerning adverse effects on non target species.

Spray Applications to Foliage The estimated environmental concentration ( EEC) values used for foliar terrestrial exposure are derived from the Kenega nomograph, as modified by Fletcher et al. ( 1994), based on a large set of actual field residue data. The upper limit values from the nomograph represent the 95th percentile of residue values from actual field measurements ( Hoerger and Kenega, 1972). The Fletcher et al. ( 1994) modifications to the Kenaga nomograph are based on measured field residues from 249 published research papers, including information on 118 species of plants, 121 pesticides, and 17 chemical classes. These modifications represent the 95th percentile of the expanded data set. Risk quotients are based on the most sensitive LC50 and NOAEC for birds and the derived dietary value for mammals ( based on acute LD50 lab rat studies). EFED uses the FATE model for multiple applications, incorporating the appropriate dissipation half life to generate EECs. For single application EECs, day zero maximum Fletcher residue values are used ( lbs ai/ A x 240, 110, 135, and 15 ppm). 39 RQ Calculations, LOCs, and Risk Presumptions for Terrestrial Animals Risk Presumption RQ LOC Birds Acute Risk EEC1/ LC50, LD50/ sq ft2, or LD50/ day3 0.5 Acute Restricted Use EEC/ LC50, LD50/ sq ft, or LD50/ day ( or LD50 < 50 mg/ kg) 0.2 Acute Endangered Species EEC/ LC50, LD50/ sq ft, or LD50/ day 0.1 Chronic Risk EEC/ NOAEC 1 Mammals Acute Risk EEC/ LC50, LD50/ sq ft, or LD50/ day 0.5 Acute Restricted use EEC/ LC50, LD50/ sq ft, or LD50/ day ( or LD50 < 50 mg/ kg) 0.2 Acute Endangered Species EEC/ LC50, LD50/ sq ft, or LD50/ day 0.1 Chronic Risk EEC/ NOAEC 1 ( 1) EEC: Estimated Environmental Concentration ( ppm) on avian/ mammalian food items. ( 2) mg/ sq ft/ LD50* wt. of bird. ( 3) ( mg of toxicant consumed/ day)/ LD50* wt. of bird.

RQ Calculations, LOCs, and Risk Presumptions for Aquatic Animals Risk Presumption RQ LOC Acute Risk EEC/( LC50 or EC50) 0.5 Acute Restricted Use EEC/( LC50 or EC50) 0.1 Acute Endangered Species EEC/( LC50 or EC50) 0.05 Chronic Risk EEC/( NOAEC) 1 RQ Calculations, LOCs, and Risk Presumptions for Plants Risk Presumption RQ LOC Terrestrial and Semi aquatic Plants Acute Risk EEC1/ EC25 1 Acute Endangered Species EEC/( EC05 or NOAEC) 1 Aquatic Plants Acute Risk EEC2/ EC50 1 Acute Endangered Species EEC/( EC05 or NOAEC) 1 ( 1) EEC = lbs a. i./ acre. ( 2) EEC = ppb or ppm in water


[Federal Register Volume 76, Number 246 (Thursday, December 22, 2011)]
[Rules and Regulations]
[Pages 79544-79545]
[FR Doc No: 2011-32852]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

46 CFR Parts 10, 11, 12, and 15

[Docket No. USCG-2011-0465]

Processing of Merchant Mariner Credentials for Those Mariners Not
Requiring a Transportation Worker Identification Credential

AGENCY: Coast Guard, DHS.

ACTION: Notice of availability.

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SUMMARY: The Coast Guard announces the availability of Policy Letter
11-15, which describes steps the Coast Guard is taking to implement a
statutory change in mariner credentialing requirements. This policy
letter details how the Coast Guard is relaxing its Transportation
Worker Identification Credential (TWIC) enforcement posture for
mariners who serve on board vessels that are not required to have a
vessel security plan. It also describes policy changes to allow these
mariners to acquire and renew a Merchant Mariner Credential (MMC)
without holding a valid TWIC.

DATES: This policy is effective upon publication of this notice.

ADDRESSES: This notice and the policy are available in the docket and
can be viewed by going to http://www.regulations.gov, inserting USCG-
2011-0465 in the ``Keyword'' box, and then clicking ``Search.'' This
material is also available for inspection or copying at the Docket
management Facility (M-30), U.S. Department of Transportation, West
Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays. This policy is also available at http://homeport.uscg.mil by clicking the ``Library'' tab > Policy > Policy
letters (inspection); CG-543 Policy Letter 11-15.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
call or email Mr. Luke Harden, Office of Vessel Activities (CG-543),
(202) 372-1206, email<EMAIL_ADDRESS>If you have questions on
viewing or submitting material to the docket, call Renee V. Wright,
Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Background and Purpose

    Coast Guard regulations require every applicant for an original or
renewal of a Merchant Mariner Credential (MMC) obtain a Transportation
Worker Identification Credential (TWIC) (see 46 CFR part 10). These
Coast Guard regulations implement 46 U.S.C. 70105(b)(2)(B) and (D),
which originally mandated that all mariners required to hold an MMC
also obtain and hold a valid TWIC. On October 15, 2010, the President
signed into law the Coast Guard Authorization Act of 2010 (the Act)
(Pub. L. 111-281), which amended Sec. 70105(b)(2) by exempting certain
mariners from the requirement to obtain and hold a valid TWIC (See
Section 809 of the Act).
    While Section 809 did not exclude any specific group of
credentialed mariners from the requirement to possess a TWIC, it gave
the Coast Guard discretion to exclude any mariner, who does not require
unescorted access to a secure area of a vessel or facility, from that
requirement (see 46 U.S.C. 70105). The Coast Guard has determined that,
under Section 809 of the Act, mariners who do not need unescorted
access to a secure area designated by a vessel security plan in
accordance with reference (c), no longer require a TWIC.
    Although full implementation of Section 809 of the Act may require
regulatory changes, the Coast Guard is issuing Policy Letter 11-15 to
implement two policy mechanisms that uses Coast Guard resources and
capabilities to lessen the impact while working on a regulatory
solution that will address the full scope of Section 809. First,
because the Coast Guard enforces its regulations by checking the
validity of TWICs while conducting inspections of vessels where the
credentials of mariners are checked, the Coast Guard is altering its
enforcement posture: excluded mariners will not be required to present
a valid TWIC during Coast Guard inspections. Second, we are
implementing policies that would make it easier for certain excluded
mariners to renew or acquire an MMC, without having to show proof of
holding a valid TWIC. Policy Letter 11-15 details procedures by which
excluded mariners do not need to obtain a physical TWIC in order to
receive an MMC, and mariners can renew an existing MMC even if their
TWIC has expired.
    We recognize that even after these policy changes many excluded
mariners will continue to need or choose to go through the TWIC
enrollment process. This is because the current MMC credentialing
process requires inputs from the TWIC enrollment process. The Coast
Guard relies on biometric and biographic information collected as part
of the TWIC enrollment process, in the security, safety, and
suitability evaluation component of Coast Guard's MMC credentialing
process. It is not possible, at this time, to issue new MMCs without
mariners going through the TWIC enrollment process. Separating the two
processes would require a significant credentialing process and
administration restructuring that is not feasible on a short timeline.
    These policy changes, however, will help to reduce the fees
mariners pay to obtain or renew a MMC, as well as reduce the burden of
having to make multiple trips to a TWIC enrollment center to apply for
and collect a TWIC. While we recognize that some mariners, particularly
those applying for their original MMC, will still have to pay the TWIC
enrollment fee, we believe that these policy changes will substantially
reduce the regulatory burden on excluded mariners. The Coast Guard is
exploring the possibility of a regulatory change to waive some fees
associated with the MMC for excluded mariners, to further reduce the
burdens in the future.

List of Excluded Mariners

    The list of excluded mariners subject to the adjusted enforcement
and credentialing policies detailed in Policy Letter 11-15 is limited
to those mariners who function solely in the following roles:
    1. Mariners serving on uninspected passenger vessels of less than
100 gross register tons (GRT);
    2. Mariners serving on vessels inspected under subchapter T of
Title 46 Code of Federal Regulations, except those on international
voyages;
    3. Mariners serving on towing vessels not involved in towing barges
inspected under 46 CFR subchapters D, I or O;
    4. Mariners serving on towing vessels involved in fleeting,
docking, or ship assist as excepted in Title 33 CFR, Section
104.105(a)(11); and
    5. Mariners who are inactive, or not operating under the authority
of their credential for long periods of time.
    This notice is issued under authority of 46 U.S.C. 70105, 33 CFR
parts 104 and 105, 46 CFR parts 10, 11, and 15, 5 U.S.C. 552(a).

    Dated: December 19, 2011.
Paul F. Thomas,
Captain, U.S. Coast Guard, Acting Director of Prevention Policy.
[FR Doc. 2011-32852 Filed 12-20-11; 11:15 am]
BILLING CODE 9110-04-P


[Federal Register Volume 82, Number 90 (Thursday, May 11, 2017)]
[Notices]
[Pages 21990-21991]
[FR Doc No: 2017-09537]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9961-51-Region 10]

Public Water Supply Supervision Program; Program Revision for the
State of Idaho

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of tentative approval.

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SUMMARY: Notice is hereby given that the State of Idaho has revised its
approved State Public Water Supply Supervision Primacy Program. Idaho
has adopted regulations analogous to the Environmental Protection
Agency's Revised Total Coliform Rule. The Environmental Protection
Agency (EPA) has determined that these revisions are no less stringent
than the corresponding federal regulations. Therefore, EPA intends to
approve these State program revisions. By approving these rules, EPA
does not intend to affect the rights of federally recognized Indian
tribes nor does it intend to limit existing rights of the State of
Idaho.

DATES: All interested parties may request a public hearing. A request
for a public hearing must be submitted by June 12, 2017 to the Acting
Regional Administrator at the EPA address shown below. Frivolous or
insubstantial requests for a hearing may be denied by the Acting
Regional Administrator. However, if a substantial request for a public
hearing is made by June 12, 2017, a public hearing will be held. If no
timely and appropriate request for a hearing is received and the Acting
Regional Administrator does not elect to hold a hearing on her own
motion, this determination shall become final and effective on June 12,
2017. Any request for a public hearing shall include the following
information: (1) The name, address, and telephone number of the
individual, organization, or other entity requesting a hearing; (2) a
brief statement of the requesting person's interest in the Acting
Regional Administrator's determination and a brief statement of the
information that the requesting person intends to submit at such
hearing; (3) the signature of the individual making the request, or, if
the request is made on behalf of an organization or other entity, the
signature of a responsible official of the organization or other
entity.

ADDRESSES: All documents relating to this determination are available
for inspection between the hours of 9:00 a.m. and 4:00 p.m., Monday
through Friday, at the Idaho Department of Environmental Quality,
Drinking Water

Program, 1410 North Hilton, Boise, Idaho 83706 and between the hours of
9:00 a.m. to 12:00 p.m. and 1:00 to 4:00 p.m. at the EPA Region 10
Library, 1200 Sixth Avenue, Seattle, Washington 98101. Copies of the
documents which explain the rule can also be obtained at EPA's Web site
at: https://www.federalregister.gov/articles/2013/02/13/2012-31205/national-primary-drinking-water-regulations-revisions-to-the-total-coliform-rule and https://www.federalregister.gov/articles/2014/02/26/2014-04173/national-primary-drinking-water-regulations-minor-corrections-to-the-revisions-to-the-total-coliform, or by writing or
calling Ricardi Duvil, Ph.D. at the address below.

FOR FURTHER INFORMATION CONTACT: Ricardi Duvil, Ph.D., EPA Region 10,
Drinking Water Unit, 1200 Sixth Avenue, Suite 900, OWW-193, Seattle,
Washington 98101, telephone<PHONE_NUMBER>, email at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

    Authority: Section 1413 of the Safe Drinking Water Act, as
amended (1996), and 40 CFR part 142 of the National Primary Drinking
Water Regulations.

    Dated: April 3, 2017.
Daniel D. Opalski,
Acting Deputy Regional Administrator, Region 10.
[FR Doc. 2017-09537 Filed 5-10-17; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 14 (Thursday, January 22, 2015)]
[Notices]
[Pages 3301-3302]
[FR Doc No: 2015-01025]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

First Meeting: RTCA Special Committee 233, Addressing Human
Factors/Pilot Interface Issues for Avionics

AGENCY: Federal Aviation Administration (FAA), U.S. Department of
Transportation (DOT).

ACTION: Meeting Notice of RTCA Special Committee 233, Addressing Human
Factors/Pilot Interface Issues for Avionics.

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SUMMARY: The FAA is issuing this notice to advise the public of the
first meeting of the RTCA Special Committee 233, Addressing Human
Factors/Pilot Interface Issues for Avionics.

DATES: The meeting will be held February 18-19th 2015 from 9:00 a.m.-
5:00 p.m.

ADDRESSES: RTCA Headquarters, 1150 18th Street NW., Suite 910,
Washington, DC 20036.

FOR FURTHER INFORMATION CONTACT: The RTCA Secretariat, 1150 18th Street
NW., Suite 910, Washington, DC 20036, or by telephone at<PHONE_NUMBER>
or<PHONE_NUMBER>, fax at<PHONE_NUMBER>, or Web site at http://www.rtca.org. In addition, Jennifer Iversen may be contacted directly
at email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal

Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is
hereby given for a meeting of Special Committee 227. The agenda will
include the following:

Tuesday, February 18th

 Welcome/Introductions/Administrative Remarks
    Chairs--Susan Taylor (Gulfstream) & Trish Ververs (Honeywell)
    Program Director--Jennifer Iversen (RTCA)
    Designated Federal Officer--Michelle Yeh (FAA)
    Secretary--Cathy Swider (FAA)
    All participants/members
 Agenda Overview--Susan Taylor & Trish Ververs
 RTCA Functional Overview--Jennifer Iversen
 Current Committee Scope, Terms of Reference Overview
Presentation, Discussion, Recommendations
 Review of Notice 8110.98, Addressing Human Factors/Pilot
Interface Issues of Complex, Integrated Avionics as Part of the
Technical Standard Order (TSO) Process
 Review of Human Factors Considerations in the Design and
Evaluation of Flight Deck Displays and Controls, Version 1.0
 Identify topic areas for deliverable
     Assign group members
 Determine/request participation of other members/groups
 Establish/review major milestones and deliverables
 Organization of Work, Assign Tasks and Workgroups
     Presentation, Discussion, Recommendations
     Assignment of Responsibilities

Wednesday February 19th

 Review Agenda, other actions
 Working Groups meeting
 Working Group report, review progress and actions
 Other Business
 Establish Agenda for Next Meeting
 Date and Place of Next Meeting

    Attendance is open to the interested public but limited to space
availability. With the approval of the chairman, members of the public
may present oral statements at the meeting. Persons wishing to present
statements or obtain information should contact the person listed in
the FOR FURTHER INFORMATION CONTACT section. Members of the public may
present a written statement to the committee at any time.

    Issued in Washington, DC, on January 15, 2015.
Mohannad Dawoud,
Management Analyst, NextGen, Program Oversight and Administration,
Federal Aviation Administration.
[FR Doc. 2015-01025 Filed 1-21-15; 8:45 am]
BILLING CODE 4910-13-P