1 Carbaryl Summary Uses C Carbaryl ( 1 naphthyl methylcarbamate) is a widely used broad spectrum insecticide. Approximately 3.9 million pounds ( 59 percent) of carbaryl is used in agriculture, and approximately 2.2 million pounds ( 34 percent) of carbaryl is used by homeowners in residential settings. The remaining uses ( 7 percent) are in the nursery, landscape and golf course industries.

C Agricultural uses include fruit and nut trees, many types of fruits and vegetables, and grain crops. Homeowners use carbaryl for lawncare, gardening, and petcare. Other uses for carbaryl include greenhouses, sod farms, mosquito adulticide use, and a special local need use of carbaryl on oyster beds in Washington State.

Health Effects C Carbaryl can cause cholinesterase inhibition in humans; that is, it can overstimulate the nervous system causing nausea, dizziness, confusion, and at high exposures, respiratory paralysis, and death.

C Carbaryl has been classified as " likely to be carcinogenic to humans" based on vascular tumors in mice.

Risks Dietary Risks from Food C Acute dietary risk estimates from food are not of concern for the entire U. S. population, including infants and children. Chronic ( cancer and noncancer) dietary risks from food are also not of concern.

Dietary Risks from Drinking Water C Carbaryl is moderately mobile in the environment, and is generally non persistent. EPA used computer modeling to generate screening level estimates of environmental concentrations of carbaryl in surface and ground water sources of drinking water C Acute and chronic ( cancer and noncancer) risks from surface and ground water sources of drinking water are not of concern for all populations when combined with food exposures. 2 Residential Risks C Exposures to homeowner handlers resulted in noncancer risks of concern for 8 out of 17 scenarios assessed. For carbaryl, dermal exposures generally determined the risk levels. Cancer risks for all 17 scenarios were not of concern.

C For postapplication exposure to homeowners, only one scenario ( lawncare) resulted in noncancer risks of concern for adults. For children 10 12, there are no risks of concern; however, postapplication exposures are of concern for toddlers for pet treatment and lawncare. Cancer postapplication risks are low for all scenarios and are not of concern.

Aggregating Dietary and Residential Risk C The Agency does not aggregate ( combine) dietary and residential exposures for residential scenarios that are already of concern by themselves. Therefore, EPA performed an aggregate assessment only for selected residential scenarios that are not already of concern. None of the these selected scenarios had aggregate risks of concern when combined with dietary food and drinking water exposures.

Occupational Exposures C Out of 140 short and intermediate term handler exposure scenario combinations, only 16 had noncancer risks of concern, even when considering the highest level of personal protection practicable ( including engineering controls). Out of 5 long term exposure scenarios, 2 had noncancer risks of concern.

C Occupational handler cancer risks for private growers were of concern for 8 of the 140 handler exposure scenario combinations. For commercial applicators, 21 scenarios had cancer risks of concern.

C Occupational postapplication risks ( noncancer and cancer) are of concern at the current 12 hour re entry interval for most scenarios.

Ecological Risks C Acute risks to birds are unlikely, but chronic risks to birds are of concern.

C There is concern for both acute and chronic risks to mammals.

C There is concern for acute risk to freshwater fish for only one scenario ( citrus use at the maximum application rate); there are no chronic risks of concern for freshwater fish. For estuarine/ marine fish, there are no acute risks of concern; for chronic exposures, risks are not expected to be of concern, however, data are needed to assess these effects. 3 C For all aquatic invertebrates, acute risks are of concern for all scenarios; chronic risks are also of concern for freshwater invertebrates, but data are needed to assess chronic risks for estuarine/ marine invertebrates.

C Risks from the Special Local Need use permit for application of carbaryl to oyster beds in Washington State were evaluated, and a separate detailed assessment of the Agency's risk estimates for this use are contained in the full carbaryl ecological risk assessment.

Endangered Species Risks ° Acute risks for endangered birds are not expected. Chronic levels of concern are exceeded for endangered birds feeding on short grasses for all uses modeled at maximum use rates except on rangeland.

° For mammals, all modeled uses exceed the acute endangered species level of concern for herbivores, and some modeled uses exceed the level of concern for mammals foraging on broadleaf plants and small insects, and for mammals feeding on large insects.

° For freshwater fish, and invertebrates, the endangered species level of concern is exceeded for all of the crops modeled for all scenarios at the maximum label use rate. For estuarine/ marine fish, only carbaryl use on citrus exceeded the acute level of concern even at the lowest rate modeled. Overview of Carbaryl Risk Assessment Introduction This document summarizes the Environmental Protection Agency's ( EPA or the Agency) revised human health and ecological risk findings and conclusions for the carbamate pesticide carbaryl, as presented fully in the revised documents, " Human Health Risk Assessment: Carbaryl" dated March 14, 2003 and " Environmental Fate and Ecological Risk Assessment for the Reregistration of Carbaryl" dated March 18, 2003. The purpose of this overview is to help the reader identify the key features and findings of these risk assessments and better understand EPA's conclusions. We developed this overview in response to comments and requests from the public which indicated that the risk assessments were difficult to understand, that they were too lengthy, and that it was not easy to compare the assessments for different chemicals due to differing formats.

Carbaryl is a carbamate insecticide, and it has been determined that N methyl carbamates share a common mechanism of toxicity: the inhibition of cholinesterase. As required by the Food Quality Protection Act ( FQPA), EPA will consider the cumulative risks from food, water and non occupational exposure resulting from all relevant uses of the group of N methyl carbamates. The risk estimates summarized in this document, however, are for carbaryl alone.

Use Profile Carbaryl ( 1 naphthyl methylcarbamate) is one of the most widely used insecticides in the U. S. Carbaryl provides broad spectrum insect pest control in agriculture, professional turf management, professional ornamental production, and in residential pet, lawn, and garden markets.

Based on information provided by the technical registrant Bayer in September 1998, it appears that approximately 34% of carbaryl is used by homeowners in residential settings, 59% is used in agriculture, and the remaining 7% is used in the nursery, landscape and golf course industries. According to Bayer, this information still reflects current trends.

C Technical Registrants. The technical registrants are Bayer ( formerly Aventis), which provided the primary data for reregistration, and Burlington Scientific Corporation.

C Agricultural Uses. Carbaryl is used in agriculture to control pests on terrestrial food crops, including fruit and nut trees ( e. g., apples, pears, almonds, walnuts, and citrus), many types of fruits and vegetables ( e. g., cucumbers, tomatoes, lettuce, blackberries, and grapes), and grain crops ( e. g., corn, rice, sorghum, and wheat).

Based on the Bayer data cited above, approximately 3.9 million pounds of active ingredient Use Profile...

2 is sold to the agricultural market. Based on available usage information for the years 1992 through 2001, the Agency estimates that total annual domestic usage of carbaryl in agriculture averaged approximately 1.9 million pounds of active ingredient for over 1.3 million acres treated. Its largest agricultural markets ( as the percentage of pounds active ingredient used annually) are Apples ( 13%), Pecans ( 10%), Grapes ( 7%), Alfalfa ( 6%), Oranges ( 6%), and Corn ( 6%). Most of this use was in California, Michigan, Indiana, Illinois, Ohio, Texas, Georgia, Oklahoma, Mississippi, and Arkansas. Crops with a high percentage of the total U. S. planted acres treated include Avocados ( 38%), Asparagus ( 35%), Okra ( 33%), Cranberries ( 32%), Apples ( 24%), Blueberries ( 22%), Sweet Cherries ( 22%), Pumpkins ( 18%), and Strawberries ( 17%).

C Residential Uses. Carbaryl is used by homeowners for lawncare, gardening ( vegetables and ornamentals), and petcare. Apart from petcare, there are no labels for indoor uses. According to recent estimates of pesticide use in residential settings, carbaryl accounted for approximately 9% of the total residential insecticide market and was ranked fourth on the list behind the pyrethroids, chlorpyrifos, and diazinon ( the latter two are now being removed from residential markets). Dust and liquid concentrate formulations account for 65% and 25%, respectively, of carbaryl sales in the residential market, which amounts to approximately 2 million pounds of active ingredient per year.

C Other uses. Carbaryl is used on ornamentals and turf, including production facilities, such as greenhouses and sod farms. It is used on golf courses and on residential sites treated by professional applicators ( e. g., annuals, perennials, and shrubs). Carbaryl is also labeled for use as a mosquito adulticide, and EPA has assessed the risks from this use. Another carbaryl application examined in the risk assessment is a special local need use to control burrowing shrimp on oyster beds in Washington State. EPA has also added a review of a special United States Department of Agriculture ( USDA) application to control grasshoppers on rangelands.

C Formulations. Carbaryl formulations include baits, dusts, aerosol sprays, ready to use pump sprayers, pet collars, pet dips and shampoos, flowable concentrates, emulsifiable concentrates, granulars, soluble concentrates, water dispersible granules, and wettable powders.

C Methods of Application. Typical application methods in agriculture include groundboom, airblast, chemigation, and aerial. Carbaryl can also be applied using handheld equipment such as low and high pressure handwand sprayers, backpack sprayers, compressed air sprayers, and turfguns. Homeowners can apply carbaryl with equipment that includes trigger sprayers, hose end sprayers, ready to use dust packaging, belly grinders, push type spreaders, and outdoor foggers.

C Application Rates. Carbaryl rates vary depending on the crop. For most agricultural uses, maximum seasonal rates range from 1 to 20 pounds active ingredient per acre. Examples of high rate applications are citrus crops, olives, and golf courses. Examples of low rate applications are certain field and row crops. Depending on the crop, the maximum number of carbaryl applications per season can range from 1 to 8. The maximum, single application rate for carbaryl is for California citrus only, specified on the label as up to 16 pounds active ingredient/ acre. 3 Human Health Risk Assessment Dietary Risk from Food Changes from the preliminary risk assessment of the dietary risks from food include updated percent crop treated values, use of a water concentration distribution in the acute aggregate assessment, and additional characterization language related to use of the carbamate market basket survey information. The estimated environmental concentrations of carbaryl in drinking water have also been significantly refined. A surface water monitoring study was also completed by Bayer which was used to characterize the most recent water modeling results.

Carbaryl risks from food consumption are summarized in Table 1 below. Risks less than 100% of the Population Adjusted Dose ( PAD), either acute ( aPAD) or chronic ( cPAD), are not of concern to the Agency. The aPAD is the dose at which a person could be exposed on any given day and no adverse health effects would be expected. The cPAD is the dose at which an individual could be exposed over the course of a lifetime and no adverse health effects would be expected. For the cancer dietary assessment, risks less than 1 x 10 6 are not of concern to the Agency.

Table 1. Summary of Dietary Food Exposure and Risk for Carbaryl ( includes Carbamate Market Basket Survey Data for oranges and bananas only)

Population Subgroup Acute ( 99.9 percentile) Chronic Cancer Exposure ( mg/ kg/ day)* % aPAD Exposure ( mg/ kg/ day) % cPAD Risk U. S. Population 0.004294 43 0.000024 < 1 2.14 x 10 8 Infants (< 1 year old) 0.006747 67 0.000055 < 1 NA Children 1 2 0.009390 94 0.000076 < 1 NA Children 3 5 0.008084 81 0.000054 < 1 NA Children 6 12 0.005434 54 0.000029 < 1 NA * mg/ kg/ day= milligrams per kilogram per day.

The acute and chronic ( noncancer) dietary food risks are not of concern to the Agency; risks are less than 100% of both the aPAD and cPAD. Cancer dietary risk is also not of concern to the Agency as the risk to the general population of 2.14 x 10 8 is less than 1 x 10 6. Below is a more detailed discussion of the dietary food risk estimates presented in Table 1. Dietary Risk from Food...

4 Acute Dietary Risk from Food Acute dietary risk from food is calculated considering what is eaten in one day for each population subgroup. In this instance, that includes the full range of consumption values as well as the range of residue values in food.

C For carbaryl, EPA conducted a Tier 3/ 4 dietary risk assessment, which is currently the most highly refined assessment possible. Dietary exposure was determined considering the level of carbaryl residues on food commodities and their potential consumption by multiple subpopulations, including infants and children. Acute dietary risk was then calculated by comparing dietary exposure to the aPAD.

C As shown in Table 1, risk estimates for all commodities are less than 100% of the aPAD for all subpopulations when considering the 99.9th percentile of exposure. The highest exposed subpopulation ( children 1 2 years) is at 94% of the aPAD, and the general population is at 43% of the aPAD. EPA also performed a crop sensitivity analysis for 1 2 year olds, and determined that removing strawberries from the dietary assessment resulted in the greatest reduction in the risk estimate, down to 71% of the aPAD.

C EPA calculated the aPAD and dietary risk levels for carbaryl using the following data:

 For the acute dietary assessment, the acute No Observed Adverse Effect Level ( NOAEL) is 1 mg/ kg/ day from a developmental neurotoxicity study in rats. Increased incidence of neurological ( functional observational battery) changes were observed on the first day of dosing in maternal animals at a Lowest Observed Adverse Effect Level ( LOAEL) of 10 mg/ kg/ day.

 The uncertainty factor ( UF) is 100 for acute dietary risk, based on a 10x for standard uncertainties in applying animal studies to humans ( interspecies extrapolation) and a 10x for varying effects among individuals ( intraspecies variability).

 The acute reference dose ( acute RfD) is 0.01 mg/ kg/ day, calculated by dividing the NOAEL ( 1 mg/ kg/ day) by the UF ( 100).

 The 10x Food Quality Protection Act Safety Factor ( FQPA SF) was removed ( i. e., is reduced to1x) for all population subgroups. The Agency determined that this safety factor is adequate to protect infants and children, because there are no residual uncertainties in the exposure databases, the toxicology database is complete, and the endpoint and NOAELs/ LOAEL for risk assessment were well defined. In the toxicology database, no quantitative or qualitative evidence of increased susceptibility in rat or rabbit fetuses following in utero exposure in the standard developmental studies was observed. There was a low level of concern for evidence of susceptibility seen in the developmental neurotoxicity study, and there was evidence of increased susceptibility in Dietary Risk from Food...

5 offspring in the 2 generation reproduction study. However, the Agency believes that the acute and chronic RfDs would be protective of these effects, so the FQPA SF was reduced to 1x.

 The aPAD is 0.01 mg/ kg/ day, calculated by dividing the acute RfD ( 0.01 mg/ kg/ day) by the FQPA SF. Since the FQPA SF is 1x, the aPAD and the acute RfD are identical.

 The acute dietary exposure analysis is based on the Dietary Exposure Evaluation Model ( DEEM FCID   ) , that uses exposure and consumption data to calculate risk as a percentage of the PAD. The DEEM FCID   analysis evaluated individual food consumption as reported by respondents in the USDA 1994 1996 and 1998 Continuing Surveys for Food Intake by Individual ( CSFII). For acute dietary risk assessments, the entire distribution of consumption events for individuals is multiplied by a randomly selected distribution of residues ( probabilistic analysis, referred to as " Monte Carlo") to obtain a distribution of exposures.

 The anticipated pesticide residues on food are extensively refined for the acute dietary assessment and were derived from: ( 1) monitoring data from USDA's Pesticide Data Program ( PDP); ( 2) FDA's Surveillance Monitoring Program; ( 3) the percentage of the crop treated ( estimated maximum percentage); ( 4) data from crop field trials where there were insufficient PDP or FDA monitoring data; and ( 5) data for oranges and bananas from the Carbamate Market Basket Survey. Field trial data were used for the following commodities: garden beets, turnips, mustards, dried beans, almonds, pecans, walnuts, field corn grain, rice, flax seed, okra, olive, peanuts, pistachio, and sunflower.

 The Agency performed a separate acute dietary exposure assessment using data for more commodities from the Carbamate Market Basket Survey ( CMBS), which is an industrysponsored year long, national survey of carbamate residues on selected food commodities purchased at grocery stores. This survey collected up to 400 single serve samples for 8 different crops ( apple, banana, broccoli, grape, lettuce, orange, peach and tomato). Residue data from a market basket survey are generally considered to provide a close approximation of residues potentially found at the " dinner plate." Survey data are generally considered the most appropriate data source for use in pesticide risk and exposure assessment.

Information from this market basket survey was considered separately from the other assessment ( except for oranges and bananas) because the survey protocol called for rubbing while washing the commodities, and that introduced a degree of uncertainty in the reported survey results for carbaryl, which is a non systemic, surface acting pesticide and thus more susceptible to residue loss from the added mechanical action of rubbing. The degree to which rubbing affected residue levels cannot be quantified. The Agency believes these survey data are useful to the carbaryl dietary risk assessment, as they tend to support PDP monitoring data findings of detectable residues on commodities important Dietary Risk from Food...

6 to the diets of infants and children. If CMBS data for all commodities is used in the assessment, the risks for the highest exposed population, children 1 2, is 86% of the aPAD.

Chronic Dietary Risk from Food Chronic ( noncancer) dietary risk from food is calculated by using the average consumption value for foods and average residue values on those foods over a 70 year lifetime. As previously shown in Table 1, dietary exposure for all populations is less than 1% of the cPAD, and therefore not of concern to the Agency.

C EPA calculated the cPAD and dietary risk levels for carbaryl using the following data:

 EPA used the Lowest Observed Adverse Effect Level ( LOAEL) of 3.1 mg/ kg/ day for the chronic dietary assessment based on a 1 year chronic toxicity feeding study in dogs. Decreases in plasma and brain cholinesterase were observed in females at this dose. Because the LOAEL dose was the lowest dose tested, a NOAEL was not established.

 The uncertainty factor ( UF) is 300, based on a 10x for standard uncertainties in applying animal studies to humans ( interspecies extrapolation) and a 10x for varying effects among individuals ( intraspecies variability), as well as a 3x for the added uncertainty of using a LOAEL instead of a NOAEL.

 The chronic reference dose ( chronic RfD) is 0.01 mg/ kg/ day, calculated by dividing the LOAEL ( 3.1 mg/ kg/ day) by the UF ( 300).

 The 10x Food Quality Protection Act safety factor ( FQPA SF) was removed ( i. e., is reduced to 1x) for all population subgroups, as discussed in the acute dietary section. The Agency determined that this safety factor s adequate to protect infants and children, because there are no residual uncertainties in the exposure databases, the toxicology database is complete, and the endpoint and NOAELs/ LOAEL for risk assessment are well defined.

 The cPAD is 0.01 mg/ kg/ day, calculated by dividing the chronic RfD ( 0.01 mg/ kg/ day) by the FQPA SF. Because the FQPA SF is 1x, the cPAD and the chronic RfD are identical.

 The chronic dietary exposure analysis is based on the Dietary Exposure Evaluation Model ( DEEM FCID   ) , which incorporates exposure and consumption data to calculate risk as a percentage of the cPAD. The DEEM FCID   analysis evaluated individual food consumption as reported by respondents in the USDA 1994 1996 and 1998 Continuing Surveys for Food Intake by Individual ( CSFII). For chronic dietary risk assessments, a 3 day average consumption for each subpopulation is combined with Dietary Risk from Food...

7 average residues in commodities to determine average exposures.

 The anticipated pesticide residues on food are extensively refined for the chronic dietary assessment for food and derived from: ( 1) monitoring data from USDA's Pesticide Data Program ( PDP); ( 2) FDA's Surveillance Monitoring Program; ( 3) the percentage of the crop treated ( weighted average); and ( 4) data from crop field trials where there were insufficient PDP or FDA monitoring data. Field trial data were used for the following commodities: garden beets, turnips, mustards, dried beans, almonds, pecans, walnuts, field corn grain, rice, flax seed, okra, olive, peanuts, pistachio, and sunflower. Carbamate Market Basket Survey data are not used for chronic dietary assessment because they reflect single serving residue values.

Cancer Dietary ( Food) Risk Cancer dietary risk from food is also calculated by using the average consumption values for food and average residue values for those foods over a 70 year lifetime. The chronic exposure value is multiplied by a linear low dose response factor ( Q1*), based on animal studies, to determine the lifetime cancer risk estimate. For cancer dietary exposure, risk estimates less than 1 x 10 6 ( 1 in 1 million) are not of concern to the Agency.

C Carbaryl is classified as " likely to be carcinogenic to humans," based on vascular tumors in mice ( males). The unit risk, or Q1* value, is 8.75 x 10 4 ( mg/ kg/ day) 1.

C The maximum estimated lifetime cancer dietary ( food) risk of 2.14 X 10 8 for the general US population is not of concern.

Drinking Water Estimated Environmental Concentrations Drinking water exposure to pesticides can occur through surface and ground water contamination. EPA considers both acute ( one day) and chronic ( lifetime) drinking water risks and uses either modeling or actual monitoring data, if available and of sufficient quality, to estimate those risks. This section describes the estimated environmental concentrations of carbaryl in the environment. Risks from exposure to these concentrations are discussed later in the section titled " Aggregating Risks from Food, Drinking Water, and Residential Exposures."

Carbaryl is fairly mobile, but is not likely to persist or accumulate in the environment. As such, it is difficult for monitoring studies to detect peak concentrations that can occur. EPA determined that currently available monitoring studies for carbaryl are limited in this regard, and did not use them to define peak values for carbaryl. Instead, EPA used screening level computer modeling to estimate drinking water estimated environmental concentrations ( drinking water Drinking Water Estimated Environmental Concentrations...

8 EECs) from ground and surface water that could be expected from normal agricultural use. Modeling is designed to provide a high end estimate of exposure.

Model Estimates C Drinking water estimated environmental concentrations for surface water were estimated using computer modeling with PRZM/ EXAMS software, scenarios using an Index Reservoir, and a Percent Crop Area factor. Drinking water EECs from modeling vary depending on different scenarios for geographic location, crop, and pesticide application rates.

C Drinking water EECs for surface water were estimated using five crop scenarios: ( 1) Ohio Sweet Corn, ( 2) Ohio Field Corn, ( 3) Pennsylvania Apples, ( 4) Minnesota Sugar Beets, and ( 5) Florida Citrus. These scenarios were selected to represent the range of crops and use rates likely to result in higher environmental concentrations. These scenarios were also modeled at different application rates: label maximum application rate, average application rate ( based on EPA's data review), and reported maximum application rate ( from DOANE survey data). Table 2 presents the EECs for drinking water from surface water sources.

Table 2. Drinking Water EECs for Surface Water based on Maximum Use Patterns for Carbaryl on Selected Agricultural Crops Crop Acute EEC Chronic EEC  : g L 1or ppb carbaryl equivalents

Apples 63 2 Citrus 316 14 Field Corn 51 3 Sweet Corn 57 6 Sugar Beets 48 2 C The drinking water EEC for groundwater ( 0.8 ppb) was estimated using the SCI GROW computer model based on the upper end agricultural application rate for carbaryl use on citrus. SCI GROW provides a screening value to use in determining exposure and the potential risk to human health from pesticide residues in groundwater.

C A primary degradate of carbaryl is 1 naphthol. The Agency is not, however, concerned about levels of 1 naphthol in drinking water for this assessment. Due to the limited persistence of 1 naphthol, it is not expected to be found in significant concentrations resulting from carbaryl applications, and even if found, it is not a cholinesterase inhibitor nor is it expected to be carcinogenic. Drinking Water Estimated Environmental Concentrations...

9 Monitoring Data Monitoring data for groundwater and surface water are available, but are of limited utility for quantitative assessment. In surface water, based on the United States Geological Survey ( USGS) National Ambient Water Quality Assessment ( NAWQA) database, carbaryl is the second most widely detected insecticide, with a significant portion apparently transported to streams. Out of 5220 surface water samples analyzed, about 21% ( 1082) had detections greater than the minimum detection limit ( 63 parts per trillion). The maximum observed concentration for carbaryl in surface water from the non targeted USGS NAWQA study is 5.5 ppb. Another finding in the NAWQA data is that streams draining urban areas showed more frequent detections and higher concentrations than streams draining agricultural or mixed land use areas. EPA has limited tools for assessing the effects of pesticide use in urban and suburban settings on surface water and groundwater quality, and may need additional data to provide estimates of the distribution of possible exposures.

Bayer also submitted results of an on going surface water monitoring study of carbaryl residues in drinking water in areas with high agricultural and residential use. In this drinking water study, raw water was collected at 16 sites in agricultural areas and four in areas draining suburban areas. Samples at municipal water treatment facilities were collected for 3 years. When raw water showed positive detections for carbaryl, finished water samples collected at the same time were analyzed. This study provides useful information on measured concentrations of carbaryl in selected surface waters of the United States, and will be used with other monitoring data to evaluate conservatism in modeling estimates of carbaryl exposure from surface drinking water sources. EPA is not using the data quantitatively for several reasons outlined in the risk assessment related to the selected carbaryl usage sites ( how representative and vulnerable they were), and the monitoring intervals necessary to capture peak concentrations for estimating acute dietary risk.

In groundwater, US EPA's Pesticides in Groundwater Database reports carbaryl detections in 0.4% of wells sampled. The EPA STORET database contains 9389 records showing analysis for carbaryl. Of these, only four reported concentrations above the detection limits, all from one well in Oklahoma, with concentrations between 0.8 and 1 ppb. In the USGS NAWQA program, 1.1% of groundwater samples recorded results above the detection limit, with a maximum concentration of 0.021 ppb. Detections were mainly from wheat, orchard and vineyard, and urban use areas. 10 Residential Risks C Residents can receive nondietary exposures to carbaryl by mixing, loading, or applying pesticides ( residential handler exposure), or by re entering an area after treatment ( residential post application exposure) by homeowners or commercial pest control applicators. Residential exposures are broadly defined to include all non dietary, nonoccupational exposures, including recreational activities like golfing, and any other exposures that can occur in the general population.

C Carbaryl has a wide variety of residential uses, including lawns, gardens, ornamentals, and pets. Other than pet treatment, there are no registered indoor uses. Carbaryl is used on golf courses, and may be used in outdoor public areas, such as schools or parks. Although EPA is not aware of public health uses of carbaryl in state or local mosquito control programs, it is labeled as a mosquito adulticide, which EPA did consider in the risk assessment. There is also potential exposure from carbaryl used in Washington State to control burrowing shrimp in oyster beds ( such as recreational activities). EPA considered this special local need use on oyster beds in the risk assessment.

C Both homeowners ( and professional applicators) can apply carbaryl by many methods, including trigger sprayers, hose end sprayers, granular spreaders, ready to use dust packaging, low pressure handwand sprayers, backpack sprayers, and turfguns.

C Residential handlers may be exposed to carbaryl residues via the dermal ( skin) and inhalation routes. Post application exposures to carbaryl for adults are most likely through the skin, whereas children may also receive oral exposures from mouthing behaviors ( i. e., hand tomouth object to mouth, and soil ingestion).

C Significant changes to the preliminary risk assessments for residential uses include the Agency's review and consideration of: a biomonitoring study of suburban residential carbaryl users and their families; pharmacokinetics and metabolism data supporting the biomonitoring study; an analysis of use and usage survey information from the Residential Exposure Joint Venture; preliminary review of a probabilistic risk assessment submitted by Bayer; and a pet collar residue dissipation study. The methods to calculate exposures to treated pets and exposures from mosquito control applications were also updated to reflect the most current approaches.

Noncancer Toxicity Summary C To estimate noncancer residential risks, the Agency calculates the ratio of the NOAEL selected for risk assessment to the exposure. This margin of exposure ( MOE= NOAEL/ exposure) is compared to a target MOE. The target MOE is the same value as the uncertainty factor ( UF) applied to the relevant toxicity study. The standard uncertainty factor is 100x ( 10x to account for interspecies extrapolation and 10x to account for intraspecies variations), plus any additional safety factor retained due to concerns unique to Residential Risk...

11 the protection of infants and children under FQPA. A MOE less than the target MOE is generally of concern to the Agency.

C For carbaryl, the 10x FQPA SF has been removed ( i. e., is 1x), for reasons explained above in the acute dietary section. Therefore, the target MOE for short and intermediate term exposures is 100. For long term exposures, the target MOE is 300, because the lowest dose tested in the long term study was a LOAEL, and a 3x uncertainty factor was added to account for uncertainties from using a LOAEL in place of a NOAEL. The only residential long term assessment for residential use is the postapplication exposure of toddlers to pet collars.

C The NOAELs and LOAELs used in the residential risk assessment are summarized below:

 Short and intermediate term dermal risk assessments for carbaryl are based on a NOAEL of 20 mg/ kg/ day from a 28 day dermal toxicity study in rats using technical grade carbaryl. Decreases in red blood cell cholinesterase in males and females, and decreases in brain cholinesterase in males, were observed at the systemic LOAEL of 50 mg/ kg/ day.

 Short term inhalation and incidental, nondietary ingestion risk assessments for carbaryl are based on a NOAEL of 1 mg/ kg/ day from a developmental neurotoxicity study in rats. Increased incidence of neurological ( functional observational battery) changes and cholinesterase inhibition ( red blood cell, plasma, whole blood, and brain) were observed at the LOAEL of 10 mg/ kg/ day. Since an oral study was used for these risk assessments, a default 100% absorption factor was applied to extrapolate for the inhalation assessments.

 Intermediate term inhalation risk assessments for carbaryl are based on a NOAEL of 1 mg/ kg/ day from a subchronic neurotoxicity study in rats. Increased incidence of neurological function changes and cholinesterase inhibition ( red blood cell, plasma, whole blood, and brain) were observed at the LOAEL of 10 mg/ kg/ day. Since an oral study was used for these risk assessments, a default 100% absorption factor was applied to extrapolate for the inhalation assessments.

 The long term ( greater than 6 month) exposure assessment for pet collars is based on a 3.1 mg/ kg/ day LOAEL from a 1 year chronic toxicity feeding study in dogs. Decreases in plasma and brain cholinesterase in females were observed at this dose. Because the LOAEL dose was the lowest dose tested, a NOAEL was not determined. Therefore, for long term exposure, the target MOE is 300 ( which includes a 3x uncertainty factor for use of a LOAEL in place of a NOAEL). Since an oral study was used for these risk assessments, a 12.7% dermal absorption factor, based on studies in the rat, was used to extrapolate for the dermal assessments. Residential Risk...

12 Noncancer Risks for Residential Handlers C EPA assessed only short term ( 1 to 30 day) exposures for residential handlers. Intermediate term exposures ( 30 days to several months) are unlikely because of the sporadic nature of applications by homeowners.

C Maximum label application rates and use information specific to residential products served as the basis for the risk calculations. If additional information was available, such as average or typical rates, EPA used these values to allow for a more informed risk management decision. In most cases, these rates differed from maximum application rates by about a factor of two.

C Exposure values in this assessment were based on three carbaryl specific residential handler studies. EPA also used two other sources of surrogate information: a study from the Outdoor Residential Exposure Task Force, of which Bayer is a member, and the Pesticide Handlers Exposure Database ( PHED).

C EPA assessed 17 major residential handler exposure scenarios, based on anticipated use patterns and current labeling for carbaryl, as well as the types of equipment and techniques used by homeowners to apply carbaryl. Most of the 17 scenarios include more than one site/ area/ rate combination. Table 3 presents the scenarios EPA considered and their associated risk estimates. Of these scenarios, 8 are of concern ( MOEs are less 100), and these scenarios and MOEs are shown in bold. In all cases, dermal exposure is the primary contributor to risk.

Table 3. Carbaryl MOEs for Combined Short term Residential Handler Dermal and Inhalation Exposures # Scenario Descriptor Use Site Amount of Carbaryl Used ( lb ai/ event) Combined Dermal and Inhalation MOEs 1 Garden: Ready to Use Trigger Sprayer Vegetables/ Ornamentals 0.012 to 0.00075 2,108 to 33,730 2 Garden/ Ornamental Dust Vegetables/ Ornamentals 0.4 to 0.1 21 to 85 0.079* 107 3 Garden: Hose End Sprayer General Use ( 2% soln) 2 21 Fire Ants 0.75 55 Other Uses: Perimeter Nuisance Pests, Vegetables, Vegetables/ Ornamentals, 0.26 to 0.012 158 to 3,427 4 Garden: Low Pressure Handwand General Use ( 2% soln), Perimeter Nuisance Pests, Vegetables, Ornamentals, Fire Ant 0.19 to 0.012 193 to 3,056 5 Trees/ Ornamentals: Low Pressure Handwand Ornamentals, Pome Fruits, Nuts/ Stone Fruits, Citrus 0.176 to 0.023 142 to 1,084 6 Trees/ Ornamentals: Hose End Sprayer Ornamentals, Pome Fruits, Nuts/ Stone Fruits, Citrus 0.5* 72 0.176 to 0.023 204 to 1,559 Residential Risk...

# Scenario Descriptor Use Site Amount of Carbaryl Used ( lb ai/ event) Combined Dermal and Inhalation MOEs 13 7 Garden: Backpack Sprayer General Use ( 2% soln), Perimeter Nuisance Pests, Vegetables, Vegetables/ Ornamentals, Fire Ants 0.19 to 0.012 1293 to 20,468 8 Lawn Care: Hose End Sprayer Lawn ( broadcast) 5 25 Lawn ( spot) 0.25 495 9 Dogs: Dusting Dog 0.0026* 142 0.1 4 0.05 7 10 Dogs: Liquid Application Dog 0.001 14,000,000**

11 Granular & Baits Lawn Care: Belly Grinder Lawn ( spot) 0.21 60 0.1 126 12 Granular & Baits Lawn Care: Push Type Spreader Lawn ( broadcast) 4.2 to 2 477 to 1,003 13 Granulars & Baits By Hand Ornamentals and Gardens 0.21 15 14 Aerosol Various 0.08 65 15 Collars: Pet Dog 0.013 10,800,000**

16 Sprinkler Can ( Source: Scenario 6) Ornamentals ( 2% solution) 0.1 359 17 Ornamental Paint On Ornamentals ( 2% solution) 0.02 297 * Average use rate based on exposure study data. ** These scenarios reflect dermal MOEs only, and are based on EPA's SOPs for Residential Exposure Assessment as opposed to monitoring data.

Noncancer Risks for Residential Postapplication Exposures Several carbaryl specific studies were used in developing this assessment, including a turf transferable residue study conducted in California, Georgia, and Pennsylvania at approximately 8 lb ai/ acre. This study was conducted using the standard protocol from the Outdoor Residential Exposure Task Force. The Agricultural Reentry Task Force conducted several dislodgeable foliar residue studies with carbaryl. The olive pruning and cabbage weeding studies were used in the home garden risk assessments.

EPA assessed the risks from postapplication exposure to carbaryl residues for the following populations: Adult Residential ( homeowner); Youth aged children ( 10 12 years old); and Toddlers ( 3 year olds). EPA considered short ( 1 to 30 days) and intermediate term ( 30 days to several months) exposures. The only long term exposure considered ( greater than 6 months) is for pet collar uses. Residential Risk...

14 Adult Residential Postapplication C EPA assessed the following 5 scenarios for adult residential postapplication exposures: residential turf for lawncare and after mosquito control; recreational swimming and beach activity ( following oyster bed treatments); golfing; home garden exposure to deciduous trees; and home garden exposure to fruiting vegetables. Within each scenario, ranges of exposure were evaluated for different application rates, duration of exposure, and postapplication activities ( e. g., weeding, harvesting). Of the 5 scenarios, only 1 is of concern: short term risks from lawncare ( i. e., heavy yardwork).

C On the day of application, the short term MOE for lawncare is 43 at an application rate of 8 lb ai/ acre. After about 5 days, residues dissipate below the level of concern. At a lower application rate of 4 lb ai/ acre, the MOE on the day of application is 88, and it takes about 1 day for residues to dissipate below the level of concern. All the remaining MOEs are greater than 500, with most in the thousands to tens of thousands. Similarly, all intermediate term exposures for residential turf are greater than 400. Table 4 presents only the MOEs associated with the scenario that exceeds the Agency's level of concern for adults.

Youth aged Children ( 10 to 12 year olds) C Children of this age can help with garden maintenance, and therefore are considered for postapplication activities related to fruiting vegetables and fruit trees ( such as weeding and harvesting). The MOEs for these activities, both short and intermediate term, were all greater than 100 on the day of application, and therefore not of concern. The lowest MOEs are approximately 650 for high exposures from deciduous trees and 980 for high exposures from fruiting vegetables; the rest of the MOEs are significantly greater than 1000.

Toddlers ( 3 year olds) C Toddlers were selected as a representative population for turf and companion animal risk assessments to provide the most conservative risk estimates. Exposures from turf were evaluated separately for lawncare uses and after mosquito control. Beach activity following oyster bed treatment was also evaluated. The assessment is based on combined risk estimates for several routes of exposure: dermal, hand to mouth, object to mouth, and soil ingestion. Table 4 presents only the MOEs associated with the scenarios that exceed the Agency's level of concern for toddlers.

C Pet treatments result in short term risks of concern for toddlers, ( MOE less than 100) even 30 days after application, regardless of whether the formulation used was a dust, liquid or collar. Hand to mouth and dermal exposures are approximately equal contributors to the overall estimates for each product type. Intermediate term risk concerns for pet treatments are similar to the short term risk concerns. One use, pet collars, is assessed as a long term exposure, and is also of concern for toddlers ( MOE= 110 compared to target MOE of 300). Pet collars are assumed to be worn by pets all of the time so long term exposures to toddlers may occur.

C Treated turf exposures ( from products labeled for direct application to turf) also result in short term risks of concern for toddlers. The MOEs are less than 100 on the day of application for both rates considered, 4 lb ai/ acre ( MOE= 11) and 8 lb ai/ acre ( MOE= 5). Residential Risk...

15 These applications required 14 days and 18 days, respectively, to reach the target MOE. Intermediate term risks to toddlers improve, based on 30 day average exposures and the dissipation rate for carbaryl, but the MOEs ( 91 and 45 for the respective use rates) are still of concern. Dermal and hand to mouth exposures are the key contributors, while soil ingestion and object to mouth exposures were minor contributors to the total risk estimates.

C Turf exposures following application of carbaryl as a mosquito adulticide are not of concern, regardless of how applications are made ( i. e., by ground or air). Both short term ( on the day of application) and intermediate term MOEs are equal to or greater than the target MOE of 100. The lowest MOEs are approximately 450 for aerial application and 850 for ground application, with the remaining MOEs ranging from the thousands to more than one hundred thousand.

C Postapplication risk estimates for toddlers playing on the beach following the Washington State Special Local Need use of carbaryl on oyster beds are not of concern to the Agency. Short term MOEs are greater than 100, even if the highest monitored sediment concentration value from any study available to the Agency was used as the basis for the calculations. The intermediate term results were similar. The lowest MOE is in the tens of thousands.

Table 4. Summary of Carbaryl Postapplication Residential Aggregate MOEs that Exceed Levels of Concern for Adults and Toddlers Population Subgroup Scenario Descriptor Results Short term MOE on Day 0 Days For Short term MOE$ 100 Intermediateterm MOE Chronic MOE Adults Residential Turf ( Lawncare) Max Rate at 4 lb ai/ A 88 1 842 NA Max Rate at 8 lb ai/ A 43 5 412 NA Toddlers Pet Treatments Liquids 9.5 + 30 18.6 NA Dusts 0.10 + 30 0.19 NA Collars 84.5 + 30 84.5 110 ( need 300)

Liquids* ( 2.6% transferability based on collars) 73.2 7 143 NA Dusts* ( 2.6% transferability based on collars) 0.73 + 30 1.43 NA Residential Turf ( High Activity) Max Rate at 4 lb ai/ A 11 14 91 NA Max Rate at 8 lb ai/ A 5 18 45 NA Inhalation MOE for children mosquito control calculated using a ground concentration of 40 ng/ L calculated with AgDrift, a respiration rate for light activity, and a 20 minute duration to allow for dissipation of the spray. The MOE for inhalation is 1609. * Alternate MOE based on data from submitted studies of marginal quality, displayed to provide a comparison to the Agency's MOEs based on standard assumptions. Residential Risk...

16 Cancer Risks for Residential Handlers C Carbaryl is classified as " likely to be carcinogenic to humans," based on increased incidence of vascular tumors in mice. Cancer risks are calculated by multiplying the Lifetime Average Daily Dose ( LADD), which represents dermal and inhalation exposure amortized over a lifetime, by the Q1* or unit risk, which is a quantitative dose response factor. The Q1* for carbaryl is 8.75 x 10 4 ( mg/ kg/ day) 1.

C For the 17 handler scenarios considered in EPA's residential handler assessment, cancer risks are not of concern to the Agency; the risks are equal to or less than 1x10 6 ( most are in the 10 8 or 10 10 range) when evaluating a single application per year.

C EPA also calculated, for each scenario, the maximum number of days a person could be exposed to carbaryl, while still not incurring risks greater than the 1 x 10 6 level of concern. All scenarios allow for exposures greater than five days, except for five scenarios, where multiple days of exposure ( five days or fewer) could result in risks of concern.

Cancer Risks for Residential Postapplication Exposures C Postapplication cancer risks were calculated only for adults and considered the same scenarios used for assessing noncancer risks.

C For all scenarios on turf, cancer risks are not of concern to the Agency; risks were in the 10 8 range or less on the day of application when evaluating a single reentry event per year during lawncare activities. Risks from home gardening, golfing, mosquito control, or oyster bed treatment, are also not of concern; they were in the 10 9 to 10 12 range when evaluating a single reentry event per year on the day of application.

C The Agency calculated, for each scenario, the maximum number of days of exposure per year which could occur and risks would be at or below 1 x 10 6 ( i. e., not of concern). Values range from 20 to over 365.

Residential Risks Calculated Based on Suburban Resident Biological Monitoring Study C Bayer submitted to the Agency a residential biological monitoring study for carbaryl, which the Agency has used to examine the exposure patterns and associated risks that can occur in households where the lawn and gardens or ornamentals have been treated.

C The biomonitoring study quantified absorbed dose levels of carbaryl in 106 people in 23 households in California and Missouri. Lawns were treated at each residence. Additionally gardens or ornamental plants were also treated at each residence.

C This study confirms the existence of risks of concern at the upper bounds of exposure ( 95th percentile and greater) similar to those modeled by the Agency for applicators, and for children exposed post application to lawn broadcast treatments with carbaryl. Depending on Residential Risk....

17 the dose calculation method used, there are also concerns at the central tendency ( mean or average) of exposure.

Refinements of Residential Risk and Characterization: Probabilistic Assessment Bayer has also submitted a probabilistic aggregate assessment using CARES, a software model which has been reviewed by the FIFRA Science Advisory Panel. This assessment includes a residential probabilistic component, which provides additional data for characterizing residential risks. The probabilistic aggregate assessment and its residential component are described in more detail in the next section on aggregating risks from food, drinking water and residential exposures.

Aggregating Risks from Food, Drinking Water and Residential Exposures Aggregate ( combined) risks for acute and chronic dietary exposures from food and drinking water are described below.

Acute Dietary Risk Estimates for Food and Drinking Water The acute dietary aggregate risk assessment in the revised human health risk assessment for carbaryl is a probabilistic aggregate assessment combining potential food and drinking water exposures. This analysis included the highest distribution of drinking water concentrations modeled using PRZM/ EXAMs ( Florida citrus, see Table 2), and incorporated this distribution, along with food residues, into DEEM FCIDTM. The results of this assessment are presented in Table 5.

Table 5. Results of Acute Dietary Risk Estimates for Combined Food and Drinking Water Exposures Population Subgroup aPAD ( mg/ kg/ day) 99.9th Percentile Exposure ( mg/ kg/ day) % aPAD General U. S. Population 0.01 0.004297 43 All Infants (< 1 year old) 0.01 0.006766 68 Children 1 2 years old 0.01 0.009257 93*

Children 3 5 years old 0.01 0.008058 81 Children 6 12 years old 0.01 0.005506 55 ( Market Basket Survey Data Not Included except for citrus and bananas) * Slight lowering ( by 1%) of the risk estimates for food alone is a result of the DEEM FDIC model making a large number of exposure calculations and rounding small numbers. Such small decreases are considered insignificant. Aggregating Risks...

18 The results from this analysis were also compared to DEEM FCIDTM results without drinking water concentrations in order to determine how much drinking water contributes to overall dietary exposure. Comparing the results presented in Table 5 with the results in Table 1 indicate that the addition of drinking water had no significant impact on the food dietary results, which essentially remained unchanged for the highest exposed population, children 1 2, and for the general population. Therefore, the acute dietary risk estimates for food and drinking water combined were not of concern.

Chronic Dietary Risk Estimates for Food and Drinking Water Combined To calculate risks from chronic drinking water exposures, the Agency used the Drinking Water Level of Comparison ( DWLOC) approach, the same approach used in the Agency's preliminary risk assessment. The DWLOC is the amount of allowable risk left for drinking water after considering how much risk is contributed by food alone. The DWLOC is compared to the estimated environmental concentration of a chemical in drinking water ( a drinking water EEC). If the DWLOC is greater than the drinking water EEC, then the risk is not of concern to the Agency. The results of this assessment are presented below in Table 6.

Table 6. DWLOCs for Chronic Dietary Food and Drinking Water Exposure Combined, and Highest Chronic Drinking Water EECs for Carbaryl at the Maximum Label Application Rate Population Subgroup Chronic DWLOC ( ug/ L or ppb) EECs Surface Water ( PRZM/ EXAMS) Ground Water ( SCI GROW) ( ppb) FL Citrus ( ppb) All Commodities Using 1994 1998 CFSII Consumption Data General Population 350 14.2 0.8 All Infants 100 14.2 0.8 Children ( 1 2 yrs) 99 14.2 0.8 Children ( 3 5 yrs) 99 14.2 0.8 Children ( 6 12 yrs) 99 14.2 0.8 For carbaryl, the chronic dietary risks for food and drinking water combined were not of concern for any subpopulation, regardless of the source of drinking water, even considering the Florida surface water EECs, which of all of the scenarios assessed, resulted in the highest drinking water EECs.

Risks from Combined Food, Drinking Water, and Residential Exposures This section describes the aggregate ( combined) risk from food, drinking water and residential exposures. The purpose of the aggregate assessment is to identify risks that become a concern when the exposure pathways are combined. Therefore, residential risks already known to be of concern alone are not part of this aggregate assessment for carbaryl. Instead, EPA selected representative scenarios where residential risks alone are not of concern.

The type of residential exposures considered for the aggregate assessment include both postapplication and handler exposures. Postapplication exposure scenarios include: mosquito control; swimming/ beach activity ( after oyster bed treatments); golfing; garden harvest; and some handler scenarios that were not of concern at a lower application rate. The handler scenarios selected include: application of dusts to gardens and pets; hose end sprayer; liquid Aggregating Risks...

19 spray spot lawn treatments; and broadcast application of granulars to lawns.

C After aggregating the dietary ( food) and residential exposures not already of concern, EPA determined, for each assessed activity, the DWLOC ( i. e., the allowable room left in the risk cup for drinking water exposure).

C EPA compared the calculated DWLOCs to the chronic drinking water EEC model estimates for both surface water and ground water. For drinking water EECs from surface water, results from carbaryl use on Florida citrus and Pennsylvania apples were used for comparison with the DWLOC, because they result in the two highest drinking water EECs for carbaryl ( see Table 2).

Short term Aggregate Risks C For those short term residential exposure scenarios that are not of concern alone, all DWLOCs are greater than the chronic drinking water EECs; therefore, aggregate risks from these scenarios are not of concern.

Intermediate term Aggregate Risks C EPA did not calculate separate intermediate term aggregate risk estimates. The results would essentially be the same as the short term aggregate risk estimates because the hazard inputs are numerically identical. Intermediate term postapplication exposures, though, would be lower, because they represent a 30 day average rather than the single day higher exposure estimate used for short term exposures.

Cancer Aggregate Risks C Aggregate cancer risks are not of concern for any subpopulation regardless of the source of drinking water, even considering the high end drinking water EECs for Florida citrus. To assess cancer risks, EPA evaluated the same adult scenarios as the short term risk assessment.

Refinement of Aggregate Assessments: Probabilistic Aggregate Assessments C Bayer has recently submitted a population based probabilistic assessment using the Cumulative and Aggregate Risk Evaluation System ( CARES) model to aggregate dietary and residential exposure from registered uses of carbaryl. The Agency has been informed that Bayer plans to submit a revised CARES assessment for carbaryl that will include drinking water along with the dietary and residential pathways. The CARES model has been reviewed by the FIFRA Science Advisory Panel.

C The Agency has begun evaluating the inputs and analysis for the CARES assessment. Because of the timing of this submission, the Agency has completed only a preliminary analysis and review of the assessment.

C Results of the submission suggest that aggregate risks are not of concern for the general population at the 99.9th percentile of exposure for the highest exposure activity ( lawn broadcast treatment). However, only a very small percentage of the general population ( approximately 0.4%) treat their lawns in this way, based on recently submitted data from the 20 Residential Exposure Joint Venture use survey. Therefore, EPA developed a " user only" analysis of the data, which suggests risk estimates of concern similar to data from the residential biomonitoring study and EPA's deterministic assessment.

Occupational Risk C The occupational risk assessment addresses on the job risks to pesticide workers who may be exposed to carbaryl when mixing, loading, or applying a pesticide ( i. e., handlers), and when entering treated sites for routine tasks ( postapplication).

C Occupational noncancer risk is being measured using the same MOE approach, and the same NOAELs and LOAELs, as are used in the residential assessment ( see the Noncancer Toxicity Summary heading in the residential section). However, the occupational assessment does not consider a FQPA SF for sensitive populations ( infants or children).

C Specific changes to the preliminary risk assessments include a reduced transfer coefficient for tree crop harvesters, from 3000 to 1500 cm2/ hr; protective headgear considered for open cab airblast applicators; and additional characterization developed for large acreage applications.

Noncancer Risks for Occupational Handlers Use Scenarios C The Agency identified 28 major occupational exposure scenarios based on the equipment and techniques that could be used for carbaryl applications, and within these scenarios there are 140 different crop/ rate/ acres combinations. These scenarios represent short term ( 1 to 30 days) and intermediate term ( 30 days to several months) exposures. A few scenarios were also assessed for long term exposures ( more than 180 days), mostly in the greenhouse and floriculture industry where long term exposures could be expected. All scenarios present the combined risk from dermal and inhalation exposures.

C Occupational handler risk assessments were conducted considering eight levels of personal protection based on different combinations of the following: ( 1) baseline protection ( typical work clothing or a long sleeved shirt and long pants, no respiratory protection and no chemical resistant gloves); ( 2) minimum personal protective equipment ( baseline scenario with the use of chemicalresistant gloves and a dust/ mist respirator with a protection factor of 5); ( 3) maximum personal protective equipment ( baseline scenario with the use of an additional layer of clothing ( e. g., a pair of coveralls), chemical resistant gloves, and an air purifying respirator with a protection factor of 10); and ( 4) engineering controls ( e. g., closed tractor cab or closed loading system for granulars or liquids). Current labels mostly specify single layer clothing, chemical resistant gloves, and no respirator.

C The maximum application rates allowed by labels were used in the risk assessments. If additional information was available, such as average or typical rates, these values were used Occupational Risk...

21 as well for a better understanding of the overall risks.

C The unit exposure values ( mg ai exposure/ lb ai handled) used in this assessment were predominantly based on the Pesticide Handlers Exposure Database ( PHED). In addition to PHED, five exposure studies were used by the Agency to estimate exposures for: ( 1) professional dog groomers; ( 2) granular products using a backpack application device ( two studies); ( 3) a ready to use trigger sprayer; and ( 4) professional lawncare operators using granular and liquid products.

Risk Summary Short term and Intermediate term risks. The risk assessment for short and intermediate term occupational exposures are similar because the toxicity endpoints ( NOAELs) are numerically the same, and the target MOE of 100 is the same for both durations.

C Out of the total of 140 crop/ rate/ area combinations assessed, 110 crop/ rate/ area combinations resulted in MOEs that meet or exceed the target MOE of 100 at some level of personal protective equipment ( PPE) or engineering controls, but usually at a higher level than that specified on the current label.

C The remaining crop/ rate/ acreage combinations resulted in MOEs that are less than the target MOE, even at the highest practical levels of PPE and engineering controls. Of these, 8 are aerial uses; 2 are wide area ground uses; 3 are granulars and baits applied by spoon, hand, or bellygrinder; 2 are for hand held devices; and 1 is for an animal groomer using a liquid application. Also, 2 crop/ rate/ area combinations for poultry use were assessed; however, Bayer has since submitted a letter to EPA requesting voluntary cancellation of the poultry use, and a Federal Register notice has been published announcing the voluntary cancellation.

C Table 7 below summarizes the noncancer risks of concern for occupational handlers for short and intermediate term exposure durations that do not meet the target MOE, even after considering the highest level of PPE and engineering controls.

Table 7. Noncancer Risks of Concern for Occupational Handlers, Short and Intermediate Term Durations at Highest Level of PPE or Engineering Controls Practical Scenario Rate ( lb ai/ acre) [ unless noted] Area Treated ( acres/ day) [ unless noted] Risk Summary / MOEs Mixer/ Loaders 1f Dry Flowable: Wide area aerial 2 ( rangeland/ forestry) 7500 58 3a Liquid: Aerial/ Chemigation 1.5 2 ( wheat, max corn) 5 ( stone fruit) 1200 350 57 76 78 3f Liquid: Wide area aerial 2 ( Range/ Forestry) 1 ( Mosquito adulticide) APHIS Grasshopper 7500 7500 6000 9 18 46 61 3g Liquid: Wide area ground 1 ( Mosquito adulticide) 3000 45 Occupational Risk...

Scenario Rate ( lb ai/ acre) [ unless noted] Area Treated ( acres/ day) [ unless noted] Risk Summary / MOEs 22 4a Wettable Powders: Aerial 1 2 ( Wheat/ corn) 5 ( stone fruit) 1200 350 40 80 55 4f Wettable Powders: Wide area aerial 2 ( Range/ Forestry) 7500 6 Applicators 5a Aerial: Agricultural uses, liquid sprays 2 ( max corn) 1200 85 5b Aerial: Wide area uses, liquid sprays 2 ( Range/ Forestry) 1 ( Mosquito adulticide max rate) APHIS Grasshopper 7500 7500 6000 14 27 68 91 5c Aerial: Agricultural uses, granular applications 2 ( corn) 2 ( corn) 1200 350 21 72 6b Airblast: Wide area uses, liquid sprays 1 ( Mosquito adulticide  max rate) 3000 22 12 High pressure handwand 4 lb ai/ 100 gallons 1000 gallons 66 13 Animal groomer, liquid application 0.01 lb ai/ dog 8 dogs 9.7 15 Granulars & baits applied by hand 9 ( Ornamentals & gardens) 1 3.8 16 Granulars & baits applied by spoon 9 ( Ornamentals & gardens) 1 75 Mixer/ Loader/ Applicators 17 Low pressure, high volume turfgun ( ORETF Data) 8 ( LCO Use on turf) 5 94 20 Granular, bellygrinder 9 ( Turf) 1 27 Note: The risk assessment also addressed poultry house uses, which the registrant has since voluntarily cancelled.

Long term risks. Only a few occupational uses are expected to result in long term exposures. Of 5 scenarios assessed, 3 meet or exceed the target MOE of 300 at some level of personal protection. The two scenarios that fail to meet or exceed the target MOE are scenario 15: granulars & baits applied by hand; and scenario 16: granulars and baits applied by spoon. Both were assessed at the maximum application rate of 9 lb ai/ acre.

Noncancer Risks for Occupational Postapplication Exposures C For postapplication exposures, EPA calculates the minimum length of time required following an application before residues have dissipated to the level where the calculated MOE reaches the target MOE. EPA uses this information to determine restricted entry intervals ( REIs), the time period after which workers are allowed to reenter a treated area. For carbaryl, the current label specifies a 12 hour REI. Occupational Risk...

23 C At the current REI, short term MOEs are of concern ( i. e., less than 100) for all but the lowest exposure scenarios in some crops. Table 8 summarizes the crop groups that result in risks of concern during short, intermediate and long term postapplication exposures, and at different levels of exposure depending on the activity and contact with treated surfaces.

Table 8. Noncancer Risks of Concern for Occupational Postapplication Exposures Low Exposure ( e. g., irrigation) Medium Exposure ( e. g., scouting) High Very High Exposure ( e. g., hand harvesting)

Short term Exposure Duration ( 1 to 30 days) Crop and # of days to reach target MOE Cut Flowers: 7 Evergreen Fruit Trees: 6 Brassica: 6 Crop and # of days to reach target MOE Cut Flowers: 9 Evergreen Fruit Trees: 17 Brassica: 9 Bunch/ Bundle Group: 6 Low/ Medium Field/ Row Crops: 3 Tall Field/ Row Crops: 4 Sugarcane: 3 Root vegetables: 4 Curbit Vegetables: 4 Leafy Vegetables: 4 Stem/ stalk Vegetables: 1 Vine/ Trellis Group: 2 Crop and # of days to reach target MOE Cut Flowers: 12 Decid Fruit Trees: 8 Brassica: 11 Bunch/ Bundle Group: 8 Low/ Medium Field/ Row Crops: 5 Tall Field/ Row Crops: 11 30 Sugarcane: 7 Root vegetables: 7 Curbit Vegetables: 7 Leafy Vegetables: 7 Stem/ stalk Vegetables: 5 Vine/ Trellis Group: 11 14 Low Berry: 4 Fruiting Vegetable: 2 Nut Trees: 11 Turf/ Sod: 14 Intermediateterm Exposure Duration ( 30 days to several months) None None Crop ( calculated MOE)

Cut Flowers ( MOE= 57) Evergreen Fruit Trees ( MOE= 59) Brassica ( MOE= 79) Turf/ Sod ( MOE= 46) Tall Field Row Crops ( MOE= 97 6) Vine/ Trellis ( MOE= 79 40)

Long Term Exposure Duration ( greater than six months) None None Crop ( calculated MOE)

Cut flower industry ( MOE= 69). Occupational Risk...

24 Cancer Risks for Occupational Handlers Occupational cancer risks equal to or less than 1 x 10 6 ( 1 in 1 million) are not of concern to the Agency. The Agency also carefully examines uses with estimated risks in the 10 6 to 10 4 range to seek cost effective ways of reducing risks. If carcinogenic risks are in this range for occupational handlers, increased levels of personal protective equipment ( PPE) or engineering controls are added to the extent practical. The Agency considered two distinct populations for the carbaryl cancer risk assessment: private growers, at 10 applications per year, and commercial applicators at 30 applications per year.

Private growers ( 10 applications per year). C Of the 140 scenario combinations considered for private growers, all scenarios have risks less than 1 x 10 6 at some level of PPE or engineering controls, except for 8 scenarios that have risks between 1 x10 4 and 10 6. Of these 8 scenarios, only 1 needed a higher level of PPE than specified on the current label to have risks in this range.

Commercial applicators ( 30 applications per year) C Of the140 scenario combinations considered for commercial applicators, all have risks less than 1 x 10 6 at some level of PPE or engineering controls, except for 21 scenarios that have risks between 1 x 10 4 and 10 6. Of these 21 scenarios, only 1 needed a higher level of PPE than specified on the current label to have risks in this range.

Cancer Risks for Occupational Postapplication Exposures Based on a 1 x 10 6 risk concern, the current REI appears adequate to address cancer risks for many crop/ activity combinations. But for higher exposure situations, longer duration REIs are necessary for risks to cease to be of concern (< 1 x 10 6). In all cases, REIs based on cancer risks are less restrictive or similar ( i. e., within a day or two of application for commercial farmworkers) than those based on the noncancer effects of carbaryl. In no cases do cancer risks indicate more restrictive REIs than for noncancer risks calculated for the corresponding exposure scenario.

Private growers ( 10 applications per year). C All scenarios have risks in the 10 6 range, except for one scenario ( very high exposure for tall field/ row crops), which was in the 10 5 range. All risks in the 10 6 range ( that is, risks greater than 1 x 10 6, such 4.4 x 10 6) take up to approximately 5 days to fall below 1 x 10 6. The risk in the 10 5 range takes 23 days to fall below 1 x 10 6.

Commercial farmworkers ( 30 applications per year). C All scenarios had cancer risks in the 10 6 range or less on the day of application at the current REI, except for two very high exposure activities ( hand harvesting). All risks in the 10 6 range take approximately 8 days to fall below 1 x 10 6. The two very high exposure activities, for tall field/ row crops and vine/ trellis crop groups, have risks in the 10 5 range on the day of application, and take 31 and 13 days, respectively, to fall below 1 x 10 6. 25 Human and Domestic Animal Incidents C The Agency evaluated reports of human carbaryl poisonings and adverse reactions associated with its use from the following sources: OPP Incident Data System ( IDS); Poison Control Centers' Toxic Exposure Surveillance System; California Department of Pesticide Regulation; the National Pesticide Telecommunications Network, now the National Pesticide Information Center ( NPIC); open literature; and an unpublished study submitted by the registrant.

C The data from IDS indicated that a majority of incidents associated with carbaryl exposure involved dermal reactions. A number of other cases involved asthmatics and people who experienced hives and other allergic type reactions. According to California data, about half of the cases involved skin and eye effects in handlers. About a quarter of the skin reactions were due to workers who were exposed to residues on crops. Reports from the literature are very limited but tend to support the finding that carbaryl has irritant properties.

C The Poison Control Center cases involving nonoccupational adult exposure and exposures of older children showed an increased risk in five of the six measures used for comparing carbaryl incidents to all other pesticides. The carbaryl cases were almost twice as likely to require serious health care ( hospitalization or treatment in a critical care unit) and were two and a half times more likely to experience major medical outcome ( life threatening effects or significant residual disability) than other pesticides. This pattern of increased risk was not seen among occupational reports or in young children, which may mean that careless handling by non professionals is a particular hazard. In addition, five case report studies suggested that carbaryl may be a cause of chronic neurological or psychological problems.

C The incident reports on domestic animals in IDS were evaluated. Based on limited data, there is some evidence that young kittens may be susceptible to adverse reactions to carbaryl. 26 Ecological Risk Assessment To estimate potential ecological risk, EPA integrates the results of exposure and ecotoxicity using the quotient method. Risk quotients ( RQs) are calculated by dividing acute and chronic exposure estimates by ecotoxicity values for various wildlife species. RQs are then compared to levels of concern ( LOCs); the higher the RQ, the greater the potential risk.

Environmental Fate Information Carbaryl dissipates in the environment by abiotic and microbially mediated degradation. The major degradation product is 1 naphthol, which is further degraded to CO2. Carbaryl is stable to hydrolysis in acidic conditions, but hydrolyzes in neutral ( half life= 12 days) and alkaline environments ( pH 9 half life= 3.2 hours). Under aerobic conditions the compound degrades rapidly by microbial metabolism, with half lives of 4 to 5 days in soil and aquatic environments. In anaerobic environments metabolism is much slower, with half lives on the order of 2 to 3 months. Carbaryl is moderately mobile in the environment. Open literature information suggests that its major degradate, 1 naphthol, is less persistent and less mobile than carbaryl. Carbaryl is not expected to bioaccumulate.

Changes to the preliminary eoological risk assessment include updated inputs for modeling estimated environmental concentrations, including new foliar dissipation values. In the risk assessment, EPA also added characterization for its assessment of Washington State's special local need use for carbaryl to control ghost or mud shrimp on oyster beds. EPA also assessed a USDA use of carbaryl to control grasshoppers and Mormon cricket on rangelands.

Nontarget Terrestrial Animal Risk Risks to Birds C Acute risks of mortality are unlikely for birds, since carbaryl is practically nontoxic to birds on both an acute and subacute dietary exposure basis. There is some uncertainty, however, regarding the sensitivity of smaller birds.

C Chronic risks of concern to birds, however, exist for the majority of uses modeled. The highest exceedance of the chronic LOC of 1 is for birds feeding on short grasses after maximum applications to turf ( RQ= 8).

Risks to Mammals C Based on estimated environmental concentrations, over 75% of the registered uses modeled are likely to represent a risk of acute mortality and chronic growth/ reproductive effects in mammals. As with most chemicals, smaller sized animals that consume a larger percentage of their body weight are more vulnerable than larger sized animals.

C The acute LOC for mammals is 0.5. Small animals are the most impacted, with a range of Ecological Risk...

27 RQs from 0.76 to 12, calculated for the maximum label use rate on citrus. Turf use resulted in the next highest RQ, at approximately 8. RQs for intermediate and large sized animals were proportionately lower, with some below the LOC.

C Acute risks from granular products were assessed separately, considering exposures from ingestion or from walking on exposed granules. Based on this analysis, small and intermediate sized animals experience acute LOC exceedances for all 40 registered granular uses ( RQs range from 0.99 to 21), while for large mammals, acute endangered species LOC ( 0.1) is exceeded for applications to trees/ ornamentals, turfgrass, and tick control ( RQ= 0.32).

C The chronic LOC for mammals is 1.0. The highest chronic risk ( RQs from 3 to 51) is for mammals feeding on short grasses following application at the maximum label rates for citrus. Turf uses again were the next highest risk quotient, at approximately 31.

Nontarget Aquatic Animal Risk C Risks from the Special Local Need use permit for application of carbaryl to oyster beds in Washington State were evaluated, and a separate, detailed assessment of the Agency's risk estimates for this use are contained in the full carbaryl ecological risk assessment.

C Acute risks to birds are low, but chronic risks to birds are of concern.

C The acute LOC for aquatic animals is 0.5, and the endangered species LOC is 0.05. For estuarine/ marine fish, no acute risk LOCs are exceeded, except for a minimal exceedance of the endangered species RQ at 0.06 for maximum label rates on citrus. For freshwater fish, only the citrus use at maximum label rates exceeds the acute risk LOC with an RQ of approximately 0.6. However, the endangered species LOC of 0.05 is exceeded for freshwater fish on all the crops modeled.

C The chronic LOC for aquatic animals is 1.0. For freshwater fish, none of the modeled uses exceeded the chronic LOC. For estuarine/ marine fish, data has not been provided to assess these risks; however, carbaryl is not likely to represent risks of chronic exposure due to its rapid degradation potential under most conditions. Data is needed for chronic effects on estuarine/ marine fish.

C Acute risks for aquatic invertebrates, both freshwater and estuarine/ marine, exceed the LOC for all scenarios at maximum label rates ( RQs from 4 to 30), and even at average application rates ( RQs from 1 to 20). Chronic risk quotients for freshwater invertebrates range from 8.7 to 55 at maximum label rates, and 2 to 34 at average rates. Data is also needed to assess chronic effects on estuarine/ marine invertebrates.

Risks to Honeybees C Technical grade carbaryl is highly toxic to honey bees on an acute contact basis. Bees are less sensitive to the formulated product, based on testing of carbaryl soluble concentrate. In Ecological Risk...

28 a field study to examine the effects of carbaryl on bees when the soluble concentrate is used to thin fruit, carbaryl application to apple orchards at a rate of 0.8 lb ai/ acre did not have a significant effect on bee mortality or behavior. Of five bee incidents reported for carbaryl, one reported acute mortality at a specific residue level ( 0.8 ppm).

Nontarget Plant Risk C For both aquatic and terrestrial plants, the likelihood of adverse effects from maximum label use rates appears to be low; however, there were limited data on which to evaluate the effects of carbaryl on a range of plants. Some phytotoxicity incidents on terrestrial plants have been reported; however, reconciling this information laboratory data represents an uncertainty.

C For aquatic plants, based on the single core green alga study available, the acute risk LOC is not exceeded for any of the five scenarios modeled, even at maximum label rates. However, toxicity testing for other plant species would be needed to fully assess carbaryl risk to aquatic plants.

Risks to Endangered Species C Acute endangered species LOCs for terrestrial animals ( birds and mammals) is 0.1; for aquatic animals ( freshwater or marine/ estuarine fish and invertebrates) it is 0.05.

C Birds. As stated earlier, acute risks for birds are not expected from carbaryl use. Chronic LOCs are exceeded for birds feeding on short grasses for all uses modeled at the maximum label rate, except rangeland. Birds feeding on other sources have LOC exceedances for about half of the scenarios modeled.

C Mammals. For mammals, all modeled uses exceed the acute endangered species LOC for herbivores, and some modeled uses exceed the LOCs for mammals foraging on broadleaf plants and small insects, and for mammals feeding on large insects. In a few modeled scenarios, granivores are affected. Again, effects vary by size of the mammal, with smaller animals most affected. For large sized animals ( 1,000g), only the carbaryl use on citrus exceeded the endangered species LOC. Granular products were again assessed separately, and represented an acute risk to both small and intermediate sized mammals on all of the uses modeled. Granules were only a risk concern to large sized mammals for trees, ornamental, turfgrass and tick control uses.

C Aquatic animals. For freshwater fish the endangered species LOC is exceeded for all of the crops modeled for all scenarios at the maximum label use rate. For freshwater invertebrates, both acute and chronic endangered species LOCs are exceeded for all of the uses modeled. For estuarine/ marine fish, only carbaryl use on citrus exceeded the acute LOC even at the lowest rate modeled. For estuarine/ marine invertebrates, the acute endangered species LOC is exceeded for all of the use and rates modeled; however, there currently are no federally listed estuarine invertebrates.


[Federal Register Volume 83, Number 199 (Monday, October 15, 2018)]
[Proposed Rules]
[Pages 51897-51898]
[FR Doc No: 2018-22264]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2015-2892; Airspace Docket No. 15-ANE-2]
RIN-2120-AA66

Proposed Amendment of Class E Airspace; Jackman, ME, and
Revocation of Class E Airspace; Newton Field, ME

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to amend Class E airspace extending
upward from 700 feet above the surface at Newton Field, Jackman, ME, to
accommodate new area navigation (RNAV) global positioning system (GPS)
standard instrument approach procedures serving the airport. Also, this
action would remove duplicative Class E airspace for Newton Field, ME.
Controlled airspace is necessary for the safety and management of
instrument flight rules (IFR) operations at this airport. This action
also would update the geographic coordinates of this airport.

DATES: Comments must be received on or before November 29, 2018.

ADDRESSES: Send comments on this rule to: U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE, West
Bldg. Ground Floor, Rm. W12-140, Washington, DC 20590; Telephone: 1-
800-647-5527, or<PHONE_NUMBER>. You must identify the Docket No. FAA-
2015-2892; Airspace Docket No. 15-ANE-2, at the beginning of your
comments. You may also submit and review received comments through the
internet at http://www.regulations.gov. You may review the public
docket containing the proposal, any comments received, and any final
disposition in person in the Dockets Office between 9:00 a.m. and 5:00
p.m., Monday through Friday, except federal holidays.
    FAA Order 7400.11C, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed on line at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11C at NARA, call<PHONE_NUMBER>, or go
to https://www.archives.gov/federal-register/cfr/ibr-locations.html.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, 1701
Columbia Ave., College Park, GA 30337; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This proposed rulemaking is promulgated under the authority
described in Subtitle VII, Part A, Subpart I, Section 40103. Under that
section, the FAA is charged with prescribing regulations to assign the
use of airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This regulation is within the scope of that
authority as it would amend Class E airspace extending upward from 700
feet above the surface at Newton Field, Jackman, ME, and remove
duplicative Newton Field, ME, information to support standard
instrument approach procedures for IFR operations at this airport.

Comments Invited

    Interested persons are invited to comment on this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
    Communications should identify both docket numbers (Docket No. FAA-
2015-2892 and Airspace Docket No. 15-ANE-2) and be submitted in
triplicate to DOT Docket Operations (see ADDRESSES section for the
address and phone number). You may also submit comments through the
internet at http://www.regulations.gov.
    Persons wishing the FAA to acknowledge receipt of their comments on
this action must submit with those comments a self-addressed stamped
postcard on which the following statement is made: ``Comments to FAA
Docket No. FAA-2015-2892; Airspace Docket No. 15-ANE-2.'' The postcard
will be date/time stamped and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this document may be changed in light of the
comments received. All comments submitted will be available for
examination in the public docket both before and after the comment
closing date. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket. All communications received on or before the specified closing
date for comments will be considered before taking action on the
proposed rule. The proposal contained in this notice may be changed in
light of the comments received. A report summarizing each substantive
public contact with FAA personnel concerned with this rulemaking will
be filed in the docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at http://www.faa.gov/air_traffic/publications/airspace_amendments/.

    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Office (see the ADDRESSES section for address and phone number) between
9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined between 8:00 a.m. and
4:30 p.m., Monday through Friday, except federal holidays at the office
of the Eastern Service Center, Federal Aviation Administration, Room
350, 1701 Columbia Avenue, College Park, GA 30337.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11C, Airspace
Designations and Reporting Points, dated August 13, 2018, and effective
September 15, 2018. FAA Order 7400.11C is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11C lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Proposal

    The FAA is considering an amendment to Title 14 Code of Federal
Regulations (14 CFR) part 71 to amend Class E airspace extending upward
from 700 feet above the surface to within a 12.4-mile (increased from a
6-mile) radius of Newton Field, Jackman, ME, providing the controlled
airspace required to support the new RNAV (GPS) standard instrument
approach procedures for IFR operations at this airport.
    This action would also make an editorial correction to remove the
duplicate airspace published in the Order under the designation Newton
Field, ME.
    The geographic coordinates of the airport also would be adjusted to
coincide with the FAAs aeronautical database.
    Class E airspace designations are published in Paragraph 6005 of
FAA Order 7400.11C, dated August 13, 2018, and effective September 15,
2018, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designations listed in this document will be published
subsequently in the Order.

Regulatory Notices and Analyses

    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this proposed rule, when promulgated, will not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

    This proposal would be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

    Authority:  49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1   [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation
Administration Order 7400.11C, Airspace Designations and Reporting
Points, dated August 13, 2018, and effective September 15, 2018, is
amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ANE ME E5 Jackman, ME [Amended]

Newton Field, ME
    (Lat. 45[deg]37'58'' N, long. 70[deg]14'56'' W)

    That airspace extending upward from 700 feet above the surface
within a 12.4-mile radius of Newton Field, excluding that airspace
outside the United States.

ANE ME E5 Newton Field, ME [Removed]

    Issued in College Park, Georgia, on October 3, 2018.
Ryan W. Almasy,
Manager, Operations Support Group, Eastern Service Center, Air Traffic
Organization.
[FR Doc. 2018-22264 Filed 10-12-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 93 (Wednesday, May 14, 2014)]
[Proposed Rules]
[Pages 27546-27547]
[FR Doc No: 2014-10990]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 170

[EPA-HQ-OPP-2011-0184; FRL-9910-56]
RIN 2070-AJ22

Pesticides; Agricultural Worker Protection Standard Revisions;
Extension of Comment Period

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; extension of comment period.

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SUMMARY: EPA issued a proposed rule in the Federal Register issue of
March 19, 2014, concerning protections from pesticides for agricultural
workers. This document extends the comment period for 60 days, from
June 17, 2014, to August 18, 2014. The comment period is being extended
to provide additional time for commenters to prepare their responses.

DATES: Comments, identified by docket identification (ID) number EPA-
HQ-OPP-2011-0184, must be received on or before August 18, 2014.

ADDRESSES: Follow the detailed instructions as provided under ADDRESSES
in the Federal Register document of March 19, 2014.

FOR FURTHER INFORMATION CONTACT: Kathy Davis, Field and External
Affairs Division (7506P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This document extends the public comment
period established in the Federal Register issue of March 19, 2014 (79
FR 15444) (FRL-9395-8). In that document, public comments were required
to be submitted on or before June 17, 2014. EPA is hereby extending
that comment period to August 18, 2014.
    To submit comments, or access the docket, please follow the
detailed instructions as provided under ADDRESSES in the March 19, 2014
Federal Register document. If you have questions, consult the person
listed under FOR FURTHER INFORMATION CONTACT.

List of Subjects in 40 CFR Part 170

    Environmental protection, Agricultural worker, Farms, Pesticides
and pests, Worker protection standards.

    Dated: May 6, 2014.
Louise P. Wise,
Acting Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2014-10990 Filed 5-13-14; 8:45 am]
BILLING CODE 6560-50-P