UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES October 15, 2004 Memorandum SUBJECT: Cypermethrin and Zeta Cypermethrin: Occupational and Residential Exposure Assessment for the Reregistration Eligibility Decision Document FROM: Seyed Tadayon, Chemist Reregistration Branch III Health Effects Division ( 7509C)

THROUGH: Danette Drew, Branch Senior Scientist Reregistration Branch III Health Effects Division ( 7509C)

TO: William Donovan, Risk Assessor Reregistration Branch III Health Effects Division ( 7509C)

PC Code: Cypermethrin: 109702; Zeta Cypermethrin: 129064 DP Barcode: Cypermethrin: D289426; Zeta Cypermethrin: 293414 The attached assessment is the occupational and non occupational ( residential) exposure and risk estimates for cypermethrin and zeta cypermethrin to support HED's reregistration eligibility decision ( RED) document. 1 Table of Contents Executive Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 1.0 Occupational and Residential Exposure/ Risk Assessment . . . . . . . . . . . . . . . . . . . . . . . . 8 1.1 Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 1.2 Criteria for Conducting Exposure Assessments . . . . . . . . . . . . . . . . . . . . . . . . . . 8 1.3 Summary of Hazard Concerns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 1.4 Incident Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 1.5 Summary of Use Patterns and Formulations . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 1.5.1 End Use Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 1.5.2 Mode of Action and Targets Controlled . . . . . . . . . . . . . . . . . . . . . . . . 13 1.5.3 Registered Use Categories and Sites . . . . . . . . . . . . . . . . . . . . . . . . . . 13 1.5.4 Application Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 2.0 Occupational Exposures and Risks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 2.1 Occupational Handler Exposures and Risks . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 2.1.1 Handler Exposure Scenarios . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 2.1.2 Data and Assumptions For Handler Exposure Scenarios . . . . . . . . . . . . 22 2.1.3 Occupational Handler Exposure and Risk Estimates . . . . . . . . . . . . . . . 31 2.1.4 Summary of Risk Concerns and Data Gaps for Handlers . . . . . . . . . . . 52 2.1.5 Recommendations For Refining Occupational Handler Risk Assessment 52 2.2. Occupational Postapplication Exposures and Risks . . . . . . . . . . . . . . . . . . . . . . 52 2.3 Occupational Risk Characterization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52 2.3.1 Handler Characterization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52 3.0 Residential and Other Non Occupational Exposures and Risks . . . . . . . . . . . . . . . . . . . 53 3.1 Residential Handler Exposures and Risks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53 3.1.1 Handler Exposure Scenarios . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53 3.1.2 Data and Assumptions For Handler Exposure Scenarios . . . . . . . . . . . . 54 3.1.3 Residential Handler Exposure and Risk Estimates . . . . . . . . . . . . . . . . . 55 3.1.4 Summary of Risk Concerns and Data Gaps for Handlers . . . . . . . . . . . 56 3.1.5 Recommendations For Refining Residential Handler Risk Assessment . . 56 3.2 Residential Postapplication Exposures and Risks . . . . . . . . . . . . . . . . . . . . . . . 56 3.2.1 Residential Postapplication Exposure Scenarios . . . . . . . . . . . . . . . . . . 56 3.2.2 Data & Assumptions for Residential Postapplication Exposure Scenarios . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57 3.2.3 Residential Postapplication Exposure and Risk Estimates . . . . . . . . . . . 58 3.2.4 Recommendations: Refining Residential Postapplication Risk Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65 3.3 Residential Risk Characterization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65 3.3.1 Characterization Of Residential Handler Risks . . . . . . . . . . . . . . . . . . . . 65 3.3.2 Characterization Of Residential Postapplication Risks . . . . . . . . . . . . . . 66 Appendix A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67 Appendix B . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106 2 Executive Summary Cypermethrin [( ± ) " cyano( 3 phenoxyphenylmethyl) ( ± ) cis/ trans 3( 2,2 dichloroethenyl) 2,2 dimethylcyclopropane carboxylate] and zeta cypermethrin [( ± ) S cyano( 3 phenoxyphenyl) methyl) ( ± ) cis/ trans 3( 2,2 dichloroethenyl) 2,2 dimethylcyclopropane carboxylate] are type II pyrethroids. They have a cyano group at the " carbon position of the alcohol moiety and are more effective when the ambient temperature is raised.

While cypermethrin and z cypermethrin are separate active ingredient, each registered in separate end use products, they are included in this assessment due to close similarity of their uses, toxicity, and chemical characteristics.

Cypermethrin and zeta cypermethrin are insecticides used on agricultural crops and animals, residential and commercial lawns, and in and around industrial, commercial, and residential premises. Cypermethrin formulations include liquid concentrates, wettable powders, and ready to use aerosols, foggers, trigger pump sprayers, impregnated wipes, and eartags. Cypermethrin can be used by homeowners on pet horses and in and around residential premises. Zeta cypermethrin formulations include liquid concentrates and ready to use dusts and impregnated tags. Applications to agricultural crops can be made with aircraft, chemigation, groundboom, airblast and various handheld equipment. Applications at industrial, commercial, and residential sites can be made using handheld equipment such as low pressure handwand sprayers, handgun sprayers, paintbrushes, and termiticides injectors, in addition to ready to use ( RTU) aerosol cans, indoor foggers, pump trigger sprayers, impregnated wipes and eartags.

Exposure Data Used In Assessment Occupational and residential handler exposure was addressed using the Pesticide Handlers Exposure Database ( PHED ver. 1.1), data from the Outdoor Residential Exposure Task Force ( ORETF), data from the Chemical Manufacturers Association, and data from a proprietary study. No handler exposure data are available to assess exposures to indoor foggers, therefore, PHED data for applying with an aerosol can are used as a reasonable worse case surrogate. In addition, EPA has no data to assess inhalation exposures during applications of impregnated wipes or eartags to animals. However, these exposures are expected to be less than exposure during applications using a ready to use ( RTU) aerosol can. Therefore, exposure assessments for the RTU aerosol products should provide risk estimates that cover these other uses.

No occupational postapplication assessment for uses on agricultural crops was completed, since no short or intermediate term dermal endpoint was identified and no long term exposures are anticipated.

The residential postapplication assessment was completed using the EPA's draft Standard Operating Procedures for Residential Exposure Assessments ( R SOPs) adopted December 18, 1997 and revised on February 22, 2001. 3 All of the studies used by the Agency to assess occupational and residential risks were considered to be the best source of data available for the scenario where it was used.

Hazard Concerns This risk assessment incorporates the toxicological endpoints of concern for cypermethrin and zeta cypermethrin as presented in the Report of the Hazard Identification Assessment Review Committee ( HIARC) February 19, 2003. The same endpoints were selected for cypermethrin and zeta cypermethrin for each route of exposure. No short or intermediate term occupational or residential dermal endpoint of concern was identified. The long term occupational and residential dermal endpoint of concern ( 6 mg/ kg/ day) is based on an oral chronic feeding study in dogs. The occupational and residential short, intermediate, and long term inhalation endpoint of concern ( 0.01 mg/ L or 2.7 mg/ kg/ day) is based on a 21 day inhalation study in rats. The incidental shortterm oral endpoint ( 10 mg/ kg/ day) is based on an acute mammalian neurotoxicity study. The intermediate term incidental oral endpoint ( 5 mg/ kg/ day) is based on a subchronic developmental neurotoxicity study. No dermal penetration/ absorption studies are available for cypermethrin or zeta cypermethrin. A dermal absorption value of 2.5% may be estimated by comparing the maternal LOAEL of 25 mg/ kg/ day from the developmental study in the rat and the NOAEL ( highest dose tested) of 1000 mg/ kg/ day from the 21 day dermal study in the rat. Since there was no common endpoint because no effects were observed in the 21 day dermal study in the rat, this is considered to be a worst case estimate.

Since the toxicological endpoints of concern for long term exposures are based on similar adverse effects, long term dermal and inhalation risks must be combined for occupational scenarios where long term exposures are anticipated. The target MOEs for long term occupational workers are 100 for dermal risk and 300 inhalation risk. Therefore, the MOEs were combined to identify an aggregate risk index ( ARI). An ARI was used since the target MOE values for inhalation and dermal exposure were different. The target ARI is 1, therefore, ARIs of less than 1 indicate risks of concern.

Cypermethrin has been classified as Category C, possible human carcinogen, based on an increased incidence of lung adenomas and adenomas plus carcinomas combined in female mice. The evidence was not considered strong enough to warrant a quantitative estimation of human risk. Cypermethrin has not been classified under the more current, Proposed Guidelines for Carcinogen Risk Assessment ( April 10, 1996). Zeta Cypermethrin is considered a weak mutagen under the conditions of the Salmonella typhimurium ( Ames) assay; however, z cypermethrin was negative in all mutagenicity studies available to the Agency. Structure activity comparisons with the other pyrethroids reveal indications of lung tumors in mice with 3 other pyrethroids.

The Agency's level of concern for risks ( i. e., target level for MOEs or Margins of Exposure) is defined by the uncertainty factors that are applied to the assessment. The Agency applies a factor of 10 to account for inter species extrapolation to humans from the animal test species and another factor of 10 to account for intra species sensitivity. The total uncertainty factors that have been applied to occupational risk assessments are 100 for long term dermal 4 exposures, and short and intermediate term inhalation exposures. However, the uncertainty factor is 300 for long term inhalation exposures. The additional 3x for long term exposure is for the lack of an alternative study on which to make an endpoint selection.

Based on the requirements of the 1996 Food Quality Protection Act, the Agency must also consider sensitive populations in its non occupational risk assessments. The Agency is applying a safety factor of 10x for non occupational exposures to cypermethrin due to the lack of a developmental neurotoxicity study. The total uncertainty factors that have been applied to nonoccupational risk assessment are 1000 for short and intermediate term incidental oral and inhalation exposures, and long term dermal exposures. An uncertainty factor of 3000 has been applied to long term inhalation exposures. The additional 3x for long term exposure is for the lack of an alternative study on which to make an endpoint selection.

Occupational Handler Risks Cypermethrin When data were available to assess risks, short and intermediate term inhalation risks to occupational handlers are below the Agency's level of concern for risk assessments ( i. e., MOE $

100) at baseline ( i. e., no respirator) for all the formulations, except wettable powder formulations. For several scenarios involving wettable powder formulation, risks are above HED's level of concern ( i. e., MOEs are less than 100) at baseline ( i. e., no respirator). The addition of a dust/ mist filtering respirator reduces the risks to below HED's level of concern for all these scenarios, except mixing/ loading to support aerial or groundboom applications to agricultural uncultivated areas, fencerows, and hedgerows and mixing/ loading to support aerial applications to sodfarms. For these three scenarios, engineering controls ( i. e., water soluble packaging) are necessary to reduce the inhalation risks to below HED's level of concern. EPA has insufficient data to assess exposures to pilots in open cockpits. Inhalation risks to pilots in enclosed cockpits ( engineering control scenario) were not a concern for all agricultural crop scenarios. No data are available to assess inhalation risks during the application of impregnated eartags to horses, however, the risks are expected to be well below the inhalation risks ( MOE= 15,000) from applications using a readyto use aerosol can ( considered to represent a worst case exposure scenario for applications of impregnated eartags to horses).

Short and intermediate term dermal risks were not assessed for occupational handlers, since no short or intermediate term dermal endpoint was identified.

A few occupational handler exposure scenarios may be considered long term, including applications to residential, commercial, and industrial turf by commercial lawn care operators and applications in and around residential, commercial, and industrial premises by commercial pest control operators. Aggregated long term dermal and inhalation risks are below HED's level of concern for all scenarios involving liquid formulations at baseline attire or with the addition of chemical resistant gloves to baseline attire. Aggregated long term dermal and inhalation risks are below HED's level of concern for all scenarios involving wettable powder formulations at baseline 5 attire or with the addition of chemical resistant gloves to baseline attire, except mixing/ loading/ applying wettable powders with a low pressure handwand sprayer. Risks were reduced to below HED's level of concern with the addition of a dust/ mist respirator and chemical resistant gloves to baseline attire for these scenarios, except for applications to residential, commercial and industrial lawns ( 0.6 lb ai/ A). Even with the addition of maximum personal protection equipment ( PPE), combined long term dermal and inhalation risks for mixing/ loading/ applying with low pressure handwand sprayer to residential, commercial and industrial lawns were still above the HED's level of concern ( i. e, ARI < 1).

Zeta Cypermethrin When data were available to assess risks, short and intermediate term inhalation risks to occupational handlers are below the Agency's level of concern for risk assessments ( i. e., MOE $

100) at baseline ( i. e., no respirator). EPA has insufficient data to assess exposures to pilots in open cockpits. Inhalation risks to pilots in enclosed cockpits ( engineering control scenario) were not a concern for all agricultural crop scenarios. No data are available to assess inhalation risks during the application of dusts via a mechanical duster and application of ready to use eartags.

Short and intermediate term dermal risks were not assessed for occupational handlers, since no short or intermediate term dermal endpoint was identified.

A few occupational handler exposure scenarios may be considered long term, including applications to residential, commercial, and industrial turf by commercial lawn care operators and applications by pest control operators. When data were available to assess risks, long term risks to occupational handlers were below the Agency's level of concern for risks ( i. e, ARI < 1) at baseline attire ( i. e., long sleeve shirt, long pants, shoes, socks, and no respirator). For mixing/ loading/ applying liquid concentrates with a handgun sprayer, no data are available to assess dermal exposures at baseline attire. However, the combined long term risks were below HED's level of concern with the addition of chemical resistant gloves to baseline attire.

Occupational Postapplication Risks EPA did not assess occupational postapplication risks to agricultural workers following treatments to agricultural crops, since no short or intermediate term dermal endpoints of concern were identified and long term exposures are not expected for tasks involving any of the registered crop use patterns. In lieu of a postapplication risk assessment, a restricted entry interval of 12 hours is assumed, unless the active ingredient and formulation meet all of the criteria listed in PR Notice 95 3 for low risk pesticides. Due to the lack of a developmental neurotoxicity study, cypermethrin and zeta cypermethrin do not meet the criteria in PR Notice 95 3 for low risk pesticides at this time.

EPA did not assess occupational postapplication exposures and risks following applications of cypermethrin and zeta cypermethrin to residential and commercial lawns, and in and around industrial, commercial, and residential premises, since no short or intermediate term 6 dermal endpoints of concern were identified and long term exposures are not expected for tasks involving any of the registered use patterns.

Residential Handler Risks In residential settings, the Agency does not use personal protective equipment to limit exposures, because they are viewed as impractical and not enforceable. Risk estimates are based on handlers wearing short sleeve shirts, short pants, shoes, and socks.

Cypermethrin No short or intermediate term dermal exposures or risks were assessed for cypermethrin, since no dermal endpoints of concern were identified. EPA does not anticipate that residential handlers would have long term exposures to cypermethrin or zeta cypermethrin. Therefore, no long term dermal or inhalation exposures or risks were assessed. EPA did assess short and intermediate term inhalation exposures and risks to residential handlers. Residential inhalation risks are below HED's level of concern ( i. e., MOE < 1000) for all non occupational handler scenarios.

Zeta Cypermethrin There are no residential handler scenarios for zeta cypermethrin. All registered uses of zeta cypermethrin are for occupational use only.

Residential Postapplication Risks In residential settings, the Agency does not use Restricted Entry Intervals ( REIs) or other mitigation approaches to limit exposures, as it might in commercial settings, because they are viewed as impractical and not enforceable. As such, risk estimates on the day of application are the key concern and the risk estimates are based on persons wearing short sleeve shirts, short pants, shoes, and socks. For cypermethrin and zeta cypermethrin, the Agency considered a number of residential postapplication exposure scenarios for different segments of the population including toddlers, youth aged children, and adults. Risks were calculated for only a few scenarios, since no short or intermediate term dermal endpoint of concern has been identified. In general, postapplication inhalation risks following outdoor applications are considered negligible. However, postapplication inhalation risks following indoor applications at residential sites may pose a concern. EPA assessed postapplication inhalation risks following indoor fogger applications using time weighted averages from the cyfluthrin room fogger study. EPA assessed postapplication inhalation risks following indoor aerosol applications using air concentration estimates from the crack and crevice subset of PHED and a House Model to estimate an emission rate.

EPA assessed postapplication risks to toddlers from incidental ingestion following broadcast applications to lawns and following spot or crack & crevice treatments to indoor 7 surfaces. The Agency aggregates risk values resulting from separate postapplication exposure scenarios when it is likely they can occur simultaneously based on the use pattern and the behavior associated with the exposed population. For cypermethrin and zeta cypermethrin, the Agency combined risk values ( i. e., MOEs) for postapplication oral exposures to toddlers associated with turf applications by combining risks from oral exposures via transfer of residues from turf to hands to mouth with risks from oral exposures via transfer from turf directly to mouth, and risks from oral exposures via incidental soil ingestion.

Cypermethrin EPA assessed postapplication risks to toddlers from incidental oral ingestion using a shortterm incidental oral endpoint ( 10 mg/ kg/ day) for cypermethrin. The results indicate that risks from short term exposures were above HED's level of concern ( i. e., MOE < 1000) for transfer from indoor surfaces to hand to mouth following crack & crevice applications to indoor surfaces ( MOE= 900).

When the postapplication risks to toddlers from incidental oral ingestion following applications to lawns were combined, the results indicate that the combined risks were above HED's level of concern for wettable powder applications at a rate of 0.6 pounds active ingredient per acre. The postapplication oral exposures to toddlers following liquid concentrate applications to lawns were below HED's level of concern at a rate of 0.44 pounds active ingredient per acre.

Zeta Cypermethrin EPA assessed postapplication risks to toddlers from incidental oral ingestion using a shortterm incidental oral endpoint ( 10 mg/ kg/ day) for zeta cypermethrin. For residential postapplication risks, MOEs are not a concern for any of the oral non dietary scenarios, because they are greater than 1000 and do not exceed HED's level of concern ( i. e., MOE < 1000) for risk assessments in nonoccupational settings.

When the postapplication risks to toddlers from incidental oral ingestion following applications to lawns were combined, the results indicate that the combined risks were below HED's level of concern. 8 1.0 Occupational and Residential Exposure/ Risk Assessment 1.1 Purpose This document is the occupational and residential non dietary exposure and risk assessment for cypermethrin and zeta cypermethrin, which will be used in the reregistration process.

1.2 Criteria for Conducting Exposure Assessments An occupational and/ or residential exposure assessment is required for an active ingredient if ( 1) certain toxicological criteria are triggered and ( 2) there is a potential for exposure to handlers ( mixers, loaders, applicators, flaggers, etc.) during use or to persons entering treated sites after application is complete. Toxicological endpoints were selected for long term dermal exposures ( NOAEL is 6.0 mg/ kg/ day); short, intermediate, and long term inhalation exposures ( NOAEL for all is 2.7 mg/ kg/ day); and for incidental ingestion ( NOAEL for short term is 10.0 mg/ kg/ day and NOAEL for intermediate term is 5.0 mg/ kg/ day). Cypermethrin and zetacypermethrin have been classified as Category C possible human carcinogens, based on an increased incidence of lung adenomas and adenomas plus carcinomas combined in female mice. However, this evidence is not considered strong enough to warrant quantitative estimation of human risk. There is a significant potential for exposure in a variety of agricultural, commercial, and residential settings. Therefore, risk assessments are required for occupational and residential handlers and for occupational and residential postapplication exposures that can occur as a result of cypermethrin and zeta cypermethrin use.

1.3 Summary of Hazard Concerns The toxicological endpoints that were used to complete the occupational and residential risk assessments are summarized below and in Table 1, which has been extracted from the latest HIARC document dated February 19, 2003. Adverse effects were identified at different durations of exposure ranging from short term ( up to 30 days) to chronic durations ( every working day). Cancer risks were not calculated for cypermethrin and zeta cypermethrin. Cypermethrin and zetacypermethrin have been classified as Category C possible human carcinogens, based on an increased incidence of lung adenomas and adenomas plus carcinomas combined in female mice. However, the evidence ( common tumor, one species of mice, in females only, plus no increase in the proportion of malignant tumors or decrease in the time to tumor occurrence, and lack of mutagenic activity) was not considered strong enough to warrant a quantitative estimation of human risk Cypermethrin and zeta cypermethrin are type II pyrethroid insecticides where the use patterns can vary widely ranging from shorter term exposures through exposures on nearly every work day. As such, when the HIARC evaluated the cypermethrin and zeta cypermethrin hazard database, endpoints were selected to address each duration of exposure. Exposures can occur to occupational users and the general population, so both were considered in this assessment. 9 No short or intermediate term dermal occupational or residential endpoints of concern were identified. The long term dermal risk assessment for cypermethrin and zeta cypermethrin is based on a NOAEL of 6 mg/ kg/ day which was defined in a chronic feeding study in dogs ( an oral study MRID 44536801). The LOAEL for this study is 20.4 mg/ kg/ day.

The short, intermediate, and long term inhalation risk assessments for cypermethrin and zeta cypermethrin are based on a NOAEL of 2.7 mg/ kg/ day which was defined in a 21 day inhalation study in rats ( MRID 43507101).

The short term incidental oral risk assessments for cypermethrin and zeta cypermethrin are based on a NOAEL of 10 mg/ kg/ day, which was defined in an acute mammalian neurotoxicity study ( MRID 44962201) and the intermediate term incidental oral risk assessments for cypermethrin are based on a NOAEL of 5 mg/ kg/ day, which was defined in a subchronic mammalian neurotoxicity study ( MRID 44962202).

A dermal absorption factor of 2.5 percent was estimated by comparing the maternal LOAEL of 25 mg/ kg/ day from the developmental study in rats and the NOAEL ( highest dose tested) of 1000 mg/ kg/ day from the 21 day dermal study in rats. Since there was no common endpoint, because no effects were observed in the 21 day dermal study in the rat, this is considered to be a worst case estimate ( i. e. the dose level of 1000 mg/ kg/ day was considered to be the NOAEL).

Since the long term toxicological endpoint of concern is based on the same adverse effect, long term dermal and inhalation exposures and risks are combined for occupational scenarios.

The Agency's level of concern for risks ( i. e., target level for MOEs or Margins of Exposure) is defined by the uncertainty factors that are applied to the assessment. The Agency applies a factor of 10 to account for inter species extrapolation to humans from the animal test species and another factor of 10 to account for intra species sensitivity. The total uncertainty factors that have been applied to occupational risk assessments are 100 for short and intermediate term inhalation exposures, 100 for long term dermal exposures, and 300 for longterm inhalation exposures. The additional 3x for long term exposure is for the lack of an alternative study on which to make an endpoint selection.

Based on the requirements of the 1996 Food Quality Protection Act, the Agency must also consider sensitive populations in its non occupational risk assessments. The Agency is applying a safety factor of 10x for non occupational exposures to cypermethrin and zetacypermethrin due to the lack of a developmental neurotoxicity study. The total uncertainly factors that have been applied to non occupational risk assessment are 1000 for short and intermediateterm incidental oral and inhalation exposures, and long term dermal exposures. An uncertainty factor of 3000 has been applied to long term inhalation exposures. The additional 3x for longterm exposure is for the lack of an alternative study on which to make an endpoint selection. 10 Table 1: Summary of Occupational and Residential Toxicology Endpoint Selection for Cypermethrin and Zeta Cypermethrin Exposure Scenario Dose Used in Risk Assessment, UF Special FQPA SF and Level of Concern for Risk Assessment Study and Toxicological Effectsb Short Term Incidental Oral ( 1 to 30 days) NOAEL= 10 mg a. i./ kg/ day Residential LOC for MOE = 1000 Occupational LOC for MOE = N/ A Acute neurotoxicity study in the rat ( zeta cypermethrin). LOAEL = 50 mg/ kg/ day based on clinical signs of neurotoxicity and changes in the FOB Intermediate Term Incidental Oral ( 1  6 months) NOAEL= 5.0 mg a. i./ kg/ day Residential LOC for MOE = 1000 Occupational LOC for MOE = N/ A Subchronic neurotoxicity study in the rat ( zeta cypermethrin). LOAEL = 26.3 mg/ kg/ day based on decreased motor activity, increased landing foot splay, and decreased body weights, body weight gains, and food consumption Short and Intermediate Term Dermal ( 1 day to 6 months None Residential LOC for MOE = N/ A Occupational LOC for MOE = N/ A No systemic effects in 21 day dermal study ( zeta cypermethrin) up to 1000 mg/ kg/ day& no developmental concern. No hazard identified to support quantitation of risk.

Long Term Dermal (> 6 months) Oral NOAEL= 6 mg a. i./ kg/ day ( dermal absorption factor = 2.5%) Residential LOC for MOE = 1000a Occupational LOC for MOE = 100 Chronic feeding study in the dog. LOAEL = 20.4/ 18.1 mg/ kg/ day based on clinical signs of neurotoxicity and mortality in males, and decreased body weights and body weight gains in females.

Short and Intermediate Term Inhalation ( 1 day to 6 months) Inhalation NOAEL= 0.01 mg a. i./ L/ day ( 2.7 mg/ kg/ day) Residential LOC for MOE = 1000 Occupational LOC for MOE = 100 21 day inhalation study in the rat. LOAEL = 0.05 mg/ L/ day ( 13.5 mg/ kg/ day) based on decrease in body weight and salivation.

Long Term Inhalation (> 6 months) Inhalation NOAEL= 0.01 mg a. i./ L ( 2.7 mg/ kg/ day) Residential LOC MOE = 3000 Occupational LOC MOE = 300 for the lack of alternative study. Route toroute estimation would result in less protective endpoint. 21 day inhalation study in the rat. LOAEL = 0.05 mg/ L/ day ( 13.5 mg/ kg/ day) based on decrease in body weight and salivation.

Cancer ( oral, dermal, inhalation) Classification: Category C ( possible human carcinogen). No quantitation required.

( a) Use a 2.5% dermal absorption factor for route to route extrapolation. UF = Uncertainty factor, FQPA SF = Food Quality Protection Act Safety Factor, NOAEL = No observed adverse effect level, LOAEL = Lowest observed adverse effect level, PAD = Population adjusted dose ( a= acute, c= chronic), RfD = reference dose, MOE = margin of exposure, LOC = Level of concern 11 A series of acute toxicity tests were also conducted using cypermethrin and zetacypermethrin   an isomeric enriched technical grade of cypermethrin ( see table 2). The results indicate that cypermethrin is category II for acute oral toxicity, category III for acute dermal toxicity and primary eye irritation effects, and category IV for acute inhalation toxicity and primary skin irritation effects. Results were negative for dermal sensitization. However, the HIARC document notes that cypermethrin and zeta cypermethrin can cause the " pyrethroid reaction" or a local site of contact sensation that is indicated by tingling and other signs and can result in scratching and secondary infections. The only study currently available for zetacypermethrin indicates that it is category II for acute oral toxicity.

Table 2: Acute Toxicity of Cypermethrin and Zeta Cypermethrin Guideline No. Study Type Toxicity Category 870.1000 Acute Oral  zeta Cypermethrin II 870.1000 Acute Oral  Cypermethrin II 870.1100 Acute Dermal Rats  Cypermethrin Rabbits  Cypermethrin III III 870.1200 Acute Inhalation  Cypermethrin IV 870.2400 Primary Eye Irritation  Cypermethrin III 870.2500 Primary Skin Irritation  Cypermethrin IV 870.2600 Dermal Sensitization  Cypermethrin N/ A * Cypermethrin and other type II pyrethroids cause a special type of dermal irritation on contact that is indicated by tingling and other signs.

1.4 Incident Reports Incident reports are addressed in a separate memo.( J. Blondell, August 26, 2003).

1.5 Summary of Use Patterns and Formulations 1.5.1 End Use Products Cypermethrin and zeta cypermethrin are broad spectrum pyrethroid insecticides marketed in a variety of end use products for both occupational and homeowner use.

Table 3 summarizes the technical and manufacturing products with their respective EPA registration numbers. 12 Table 3: Technical and Manufacturing Cypermethrin and zeta Cypermethrin Products Formulation EPA Reg. No. (% active ingredient)

Cypermethrin Technical 100 989 ( 90%); 279 3026 ( 88.00%); 279 3275 ( 88%); 53883 89 ( 96.70%); 70506 10 ( 96.70%); 73049 385 ( 90%); 73049 386 ( 88%)

Cypermethrin Manufacturing Product 100 1018 ( 70.00%); 279 3026 ( 88.00%)

z Cypermethrin Technical 279 3124 ( 88%)

z Cypermethrin Manufacturing Product 279 3250 ( 36%); 279 3256 ( 17.1%); 279 3260 ( 18.1%)

Based on a review by the Office of Pesticide Programs   Pesticide Product Label System ( PPLS) and registrant input, cypermethrin formulations include liquid concentrates, wettable powders, wettable powders in water soluble packaging, ready to use aerosol sprays; ready to use trigger pump sprayers, ready to use indoor foggers, ready to use wipes, and ready to use ear tags. Zeta cypermethrin formulations include liquid concentrates and ready to use dusts and impregnated tags. Tables 4a and 4b outline the formulations and EPA registration numbers for labels of cypermethrin and zeta cypermethrin end use products according to PPLS and the registrant. Many of the products described in Tables 4a and 4b can be used in a variety of settings ranging from agriculture crops to commercial, industrial, and residential premises.

Table 4a: Cypermethrin End Use Product Formulations and EPA Reg. Number Formulation EPA Reg. No. (% active ingredient)

Concentrates 4 427 ( 26.00%); 100 1004 ( 25.30%); 100 1006 ( 25.3%); 100 1109 ( 25.3%) 270 250 ( 0.60%); 279 3027 ( 30.60%); 279 3044 ( 30.60%); 279 3046 ( 30.60%); 279 3081 ( 24.80%); 279 3082 ( 24.80%); 279 3118( 43.20%); 279 3120 ( 27.90%); 279 3209 ( 30.60%); 279 3131 ( 30.60%); 28293 284 ( 26.00%); 45385 94 ( 26.00%) 53883 27 ( 25.30%); 53883 92 ( 25.30%); 53883 104 ( 30.60%); 70506 19 ( 24.8%); 70506 20 ( 30.6%); 70506 21 ( 30.6%); 73049 154 ( 26.00%); 73049 317 ( 24.8%)

Wettable Powders 100 990 ( 40.00%); 279 3070 ( 40.00%); 279 3109 ( 50.00%); 432758 ( 40.00%); 53883 29 ( 40.00%)

Wettable Powders in water soluble Bags 100 1000 ( 40.00%) 279 3084 ( 38.70%); 279 3085 ( 35.60%); 2793117 ( 50.00%); 282 3084 ( 38.70%) 73049 318 ( 35.6%)

Ready to Use 270 251 ( 0.15%); 270 253 ( 0.15%); 270 316 ( 0.50%); 498 190 ( 1.716%); 39039 2 ( 7.0%); 4822 389 ( 0.15%); 4822 436 ( 0.15%); 4822 447 ( 0.10%); 4822 452 ( 1.716%); 9444 182 ( 0.10%); 9444128 ( 0.10%); 39039 21 ( 7.00%) 53883 94 ( 0.15%); 73049 157 ( 0.05%)

Table 4b: Zeta cypermethrin End Use Product Formulations and EPA Reg. Number Formulation EPA Reg. No. (% active ingredient)

Liquid Concentrates 279 3125 ( 18.1%); 279 3126 ( 17.1%); 279 3242 ( 17.1%); 279 3248 ( 9.2%); 279 3249 ( 9.60%)

Ready to Use 39039 4 ( 10%); 39039 9 ( 0.075%); 39039 11 ( 10%) 13 1.5.2 Mode of Action and Targets Controlled Cypermethrin and zeta cypermethrin are type II pyrethroids. The type II pyrethroids produce a characteristic toxicity response in both insects and mammals that is distinct from the type I pyrethroids. The Type II pyrethroids produce responses that include choreoathetosis writhing in mammals.

1.5.3 Registered Use Categories and Sites An analysis of the current labeling and available use information was completed. Cypermethrin is registered for use in a variety of occupational and homeowner/ residential scenarios. Zeta cypermethrin is registered for use in a variety of occupational scenarios. Residential handler use scenarios are not expected for zeta cypermethrin, however, there is a potential for postapplication exposure to treated turf/ lawns. For reasons of clarity in the risk assessment process, the use patterns have been described in a manner that delineates occupational from homeowner/ residential uses. Use sites, maximum applications rates, and area treated are provided in Tables 5a and 5b for cypermethrin. Use sites, maximum applications rates, and area treated are provided in Tables 6a and 6b for zeta cypermethrin.

Cypermethrin Occupational Use Sites Occupational populations are potentially exposed while making cypermethrin applications to the following targets or after contact with the treated targets after previous cypermethrin applications. The following list is a summary of occupational use sites.

Table 5a: Summary of Maximum Application Rates for Registered Cypermethrin Agricultural Crop Uses Crop or Target Maximum Application Rate ( lb ai/ acre) Application Equipment Area Treated or Amount Handled Daily ( acres)

Cotton 0.1 aerial 1200 chemigation 350 groundboom 200 Broccoli, Broccoli Raab, Brussel Sprouts, Bok Choy, Cabbage, Cauliflower, Cavalo Broccolo, Chinese Broccoli, Chinese Cabbage, Collards, Head Lettuce, Kale, kohlrabi Mizuna, Mustard Greens, Mustard Spinach, Pecans, Rape Greens 0.1 aerial 350 chemigation 350 groundboom 80 Pecans 0.1 aerial 350 chemigation 350 Table 5a: Summary of Maximum Application Rates for Registered Cypermethrin Agricultural Crop Uses Crop or Target Maximum Application Rate ( lb ai/ acre) Application Equipment Area Treated or Amount Handled Daily ( acres)

14 airblast 40 Sodfarms 0.74 aerial 350 groundboom 80 Agricultural Uncultivated Areas, Fencerows, Hedgerows 3.4 aerial 350 airblast 80 handgun 5 Ornamental Plants 3.4 groundboom 40 airblast 20 handgun 5 0.008 lb ai/ gal low pressure handwand sprayer 40 gallons Top Soil, Potting Soil 3.4 handgun 5 Table 5b: Summary of Maximum Application Rates for Registered Cypermethrin Occupational ( not Agricultural Crop) Uses Crop or Target Maximum Application Rate Application Equipment Area Treated or Amount Handled Daily Residential, Commercial and Industrial Lawns 0.6 lb ai/ A ( wettable powders) 0.44 lb ai/ A ( liquid concentrate) low pressure handwand sprayer 5 acres handgun sprayer 5 acres Termites applications to soil and sides of buildings near to ground, building perimeters, masonry voids, and standing wood in uninhabited areas at residential, commercial and industrial sites 0.05 lb ai/ gallon low pressure handwand sprayer 40 gallons paint brush 5 gallons Termites applications to preconstruction lumber and logs, and to soil under firewood 0.041 lb ai/ gallon low pressure handwand 40 gallons paint brush 5 gallons Crop or Target Maximum Application Rate Application Equipment Area Treated or Amount Handled Daily 15 Non termite applications to indoor and outdoor surfaces at residential, commercial and industrial sites, animal premises, and greenhouses; 0.017 lb ai/ gallon ( crack & crevice) low pressure handwand 40 gallons paint brush 5 gallons 0.005 lb ai/ 16 oz can aerosol can Two 16 ounce cans 0.0014 lb ai/ fogger ( broadcast) indoor fogger Four 1.5 ounce foggers Termite Applications to standing wood in uninhabited areas at residential, commercial and industrial sites 0.008 lb ai/ gallon low pressure handwand 40 gallons Termites: trees, utility poles, fenceposts, building voids 0.05 lb ai/ gallon termiticide injector 500 gallons Cattle 0.003 lb ai/ 2 ear tags ear tag 100 and 1000 cattle Horses 0.017 lb ai/ gallon low pressure handwand 40 gallons ready to use pump trigger 1 gallon 0.00041 lb ai/ wipe ready to use wipe 50 and 500 horses Table 5b: Summary of Maximum Application Rates for Registered Cypermethrin Residential Uses Crop or Target Maximum Application Rate Application Equipment Area Treated or Amount Handled Daily Indoor Spaces 0.0014 lb ai/ fogger ready to use fogger Two 1.5 ounce foggers Indoor surfaces 0.005 lb ai/ sixteen ounce can aerosol can One 16 ounce can Horses 0.017 lb ai/ gallon low pressure handwand 5 gallons ready to use pump trigger 0.1 gallon mix and wipe 0.1 gallon 0.00041 lb ai/ wipe ready to use wipe 1 horse 16 Zeta Cypermethrin Table 6a: Summary of Maximum Application Rates for Registered Zeta Cypermethrin Agricultural Uses Crop or Target Maximum Application Rate ( lb ai/ acre) Application Equipment Area Treated or Amount Handled Daily ( acres)

Alfalfa, Alfalfa grown for seed, Corn, sweet, field, pop, and field grown for seed; Cotton ( foliar use), Rice, Soybeans, Wheat, and Triticale 0.05 aerial 1200 chemigation 350 groundboom 200 Bulb Vegetables include garlic, great headed garlic, green eschalots, Japanese bunching onions, leeks, dry bulb and green onion, welch onion, dry bulb and green shallots, and scallions; Fruiting Vegetables ( except cucurbits) include eggplant, ground cherry, pepino, tomatillo, tomato, and peppers   bell, chili, cooking, sweet pepper, pimento; Grain Sorghum and Millet; Head/ Stem Brassica Vegetables include broccoli, Chinese broccoli, Brussels sprouts, cauliflower, cavalo broccolo, kohlrabi, cabbage, and Chinese cabbage; Head Lettuce; Leafy Brassica Greens include broccoli raab, bok choy, Chinese mustard cabbage, collards, kale, mizuna, mustard greens, mustard spinach, and rape greens; Leafy Vegetables ( except Brassica) include leafy amaranth, Chinese spinach, tambala roquette, cardoon, celery, Chinese celery, celtuce, chervil, edible leaf and garland chrysanthemum, corn salad, upland & garden cress, dandelion, dock, endive, escarole, fennel, Florence, head and leaf lettuce, orach, parsley, garden and winter purslane, radiccio, rhubarb, spinach, and Swiss chard; Succulent Edible Podded Beans include wax bean, asparagus bean, Chinese longbean, moth bean, yardlong bean, Jackbean, immature soybean seed, sword bean, lima bean, broad been, black eyed pea, southern pea, grain lupin, sweet lupin, white lupin, white sweet lupin, field bean, kidney bean, navy bean, pinto bean, tepary bean, adzuki bean, catjang, crowder pea, moth bean, mung bean rice bean, curd bean, chickpea, guar, and lablab bean; Succulent Edible Podded Peas include dwarf pea, edible pod pea, snow pea, sugar snap pea, pigeon pea, English pea, garden pea, green pea, and lentil; Sugarbeet; Sugarcane 0.05 aerial 350 chemigation 350 groundboom 80 Pecans 0.05 aerial 350 chemigation 350 airblast 40 17 Table 6b: Summary of Maximum Application Rates for Registered Zeta Cypermethrin Commercial Uses Crop or Target Maximum Application Rate Application Equipment Area Treated or Amount Handled Daily Livestock ( beef and dairy cattle, sheep, goats, horses) 0.00094 lb ai/ animal mechanical duster 1000 animals shaker can 100 animals Livestock ( cattle) 0.004 lb ai/ 2 ear tags/ cattle ready to use ear tags 100 and 1000 cattle 0.003 lb ai/ 1 ear tag/ cattle Indoor surfaces 0.003 lb ai/ gallon low pressure handwand 40 gallons Residential lawns and Turfgrass at Commercial Sites 1 lb ai/ acre low pressure handwand 2 acres Residential lawns 1 lb ai/ acre handgun sprayer 5 acres Outdoor surfaces 0.001 lb ai/ gallon low pressure handwand 40 gallons paintbrush 5 gallons Outdoor surfaces ( ant mounds) 0.006 lb ai/ mound watering can 40 mounds Outdoor surfaces: vegetation, refuse dumps, garages, and other outdoor surfaces, Turfgrass: adjacent to or around private homes, duplexes, townhouses, condominiums, house trailers apartment complexes, carports, garages, fence lines, storage sheds, barns, and other residential structures plus commercial, industrial, institutional buildings, Surfaces of buildings: porches, screens, window frames, eaves, patios, lawn area adjacent to or around private homes, duplexes, townhouses, condominiums, house trailers apartment complexes, carports, garages, fence lines, storage sheds, barns, and other residential structures plus commercial, industrial, institutional buildings 0.4356 lb ai/ acre handgun sprayer 5 acres 1.5.4 Application Parameters Application parameters are generally defined by the physical nature of the use site, the physical nature of the formulation ( e. g., formula and packaging), by the equipment required to deliver the chemical to the use site, and by the application rate required to achieve an efficacious dose. 18 2.0 Occupational Exposures and Risks It has been determined there is a potential for occupational exposure from handling cypermethrin and zeta cypermethrin products during the application process ( i. e., mixer/ loaders, applicators, flaggers and mixer/ loader/ applicators) and from entering areas previously treated with cypermethrin and zeta cypermethrin ( e. g., postapplication worker exposure). As a result, risk assessments have been completed for occupational handler and postapplication scenarios.

2.1 Occupational Handler Exposures and Risks There are distinct job functions or tasks related to pesticide applications and exposures that can vary depending on the specifics of each task. Job requirements ( e. g., amount of chemical to be used in an application), formulation, the kinds of equipment used, the target being treated, and the circumstances of the user ( e. g., the level of protection used by an applicator) can cause exposure levels to differ in a manner specific to each application event.

2.1.1 Handler Exposure Scenarios The purpose of this section is to describe the exposure scenarios that were used by the Agency in the assessment for cypermethrin and zeta cypermethrin handlers. Information from the current labels; use and usage information; toxicology data; and exposure data were all key components in developing the exposure scenarios.

Tasks associated with occupational pesticide use ( i. e., for " handlers") can generally be categorized using one of the following terms:

C Occupational Mixers and/ or Loaders: these individuals perform tasks in preparation for an application.

C Occupational Applicators: these individuals operate application equipment during the release of a pesticide product on to the intended target.

C Occupational Mixer/ Loader/ Applicators: these individuals are involved in the entire pesticide application process ( i. e., they do all job functions related to a pesticide application event).

C Occupational Flaggers: these individuals guide aerial applicators during the release of a pesticide product onto an intended target.

The anticipated use patterns and current labeling indicate several occupational exposure scenarios based on the types of equipment and techniques that can potentially be used to make cypermethrin and zeta cypermethrin applications. The quantitative exposure/ risk assessment developed for occupational handlers is based on these scenarios. [ Note: The scenario numbers correspond to the tables of risk calculations included in the occupational risk calculation aspects 19 of the Appendix A.]

Cypermethrin Short and Intermediate term Scenarios ( Inhalation Exposure only):

Mixer/ Loader:

( 1a) Liquid Formulations: Mixing/ Loading to support Aerial Applications ( 1b) Liquid Formulations: Mixing/ Loading to support Chemigation Applications ( 1c) Liquid Formulations: Mixing/ Loading to support Groundboom Applications ( 1d) Liquid Formulations: Mixing/ Loading to support Airblast Applications ( 2a) Wettable Powder Formulations: Mixing/ Loading to support Aerial Applications ( 2b) Wettable Powder Formulations: Mixing/ Loading to support Chemigation Applications ( 2c) Wettable Powder Formulations: Mixing/ Loading to support Groundboom Applications ( 2d) Wettable Powder Formulations: Mixing/ Loading to support Airblast Applications Applicator: ( 3) Applying with Sprays with Aircraft ( 4) Applying with Groundboom Equipment ( 5) Applying with Airblast Equipment Flagger: ( 6) Flagging to support Aerial Spray Applications Mixer/ Loader/ Applicator:

( 7) Liquid Formulations: Low Pressure Handwand Sprayer ( 8) Liquid Formulations: Paint Brush ( 9) Liquid Formulations: Low Pressure/ High Volume Turf/ Handgun Sprayer ( 10) Liquid Formulations: Termiticide Injector ( 11) Wettable Powder Formulations: Low Pressure Handwand Sprayer ( 12) Wettable Powder Formulations: Paint Brush ( 13) Wettable Powder Formulations: Low Pressure/ High Volume Turf/ Handgun Sprayer ( 14) Water Soluble Bag Formulations: Low Pressure/ High Volume Turf/ Handgun Sprayer ( 15) Ready to Use Ear Tag ( 16) Ready to Use Trigger Pump Sprayer ( 17) Ready to Use Wipes ( 18) Ready to Use Aerosol Can ( 19) Ready to Use Fogger 20 Cypermethrin Long term Scenarios ( Dermal and Inhalation Exposure):

Mixer/ Loader/ Applicator:

( 1) Liquid Formulations: Low Pressure Handwand Sprayer ( 2) Liquid Formulations: Paint Brush ( 3) Liquid Formulations: Low Pressure/ High Volume Turf/ Handgun Sprayer ( 4) Wettable Powder Formulations: Low Pressure Handwand Sprayer ( 5) Wettable Powder Formulations: Paint Brush ( 6) Wettable Powder Formulations: Low Pressure/ High Volume Turf/ Handgun Sprayer ( 7) Water Soluble Bag Formulations: Low Pressure/ High Volume Turf/ Handgun Sprayer Zeta Cypermethrin Short and Intermediate term Scenarios ( Inhalation Exposure only):

Mixer/ Loader:

( 1a) Liquid Formulations: Mixing/ Loading to support Aerial Applications ( 1b) Liquid Formulations: Mixing/ Loading to support Chemigation Applications ( 1c) Liquid Formulations: Mixing/ Loading to support Groundboom Applications ( 1d) Liquid Formulations: Mixing/ Loading to support Airblast Applications ( 2) Loading Dusts into Mechanical Duster ( using PHED wettable powders data)

Applicator: ( 3) Applying with Sprays with Aircraft ( 4) Applying with Groundboom Equipment ( 5) Applying with Airblast Equipment ( 6) Applying Dusts via Mechanical Duster Flagger: ( 7) Flagging to support Aerial Spray Applications Mixer/ Loader/ Applicator: ( 8) Liquid Formulations: Low Pressure Handwand Sprayer ( 9) Mixing/ Loading/ Applying Liquid Concentrates with a Handgun Sprayer ( LCO ORETF data) ( 10) Applying Dusts via Shaker Can ( MRID 444598 01) ( 11) Mixing/ Loading/ Applying Liquid Concentrates with a Watering Can ( using ORETF residential hose end data) ( 12) Mixing/ Loading/ Applying Liquid Concentrates with a Paint Brush ( 13) Applying Ready to Use Ear Tags ( 14) Loading Dusts into Self Applying Dust Bags ( using PHED mixing/ loading wettable powders data) 21 Zeta Cypermethrin Long term Scenarios ( Dermal and Inhalation Exposure):

Mixer/ Loader/ Applicator:

( 1) Mixing/ Loading/ Applying Liquid Concentrates with Low Pressure Handwand ( PHED) ( 2) Mixing/ Loading/ Applying Liquid Concentrates with a Handgun Sprayer ( LCO ORETF data) ( 3) Mixing/ Loading/ Applying Liquid Concentrates with a Watering Can ( using ORETF residential hose end data) ( 4) Mixing/ Loading/ Applying Liquid Concentrates with a Paint Brush 2.1.2 Data and Assumptions For Handler Exposure Scenarios A series of assumptions and exposure factors served as the basis for completing the occupational handler risk assessments. Each assumption and factor is detailed below on an individual basis. The assumptions and factors used in the risk calculations include:

C Average body weight of an adult handler is 70 kg.

C Handler assessments were completed using PHED, ORETF, and proprietary data. Some of the PHED data were " low quality" but were used because of the lack of a more acceptable dataset. The PHED unit exposure values range between the geometric mean and the median of the available exposure data. The ORETF data were high quality and geometric mean values were used. Proprietary data were used to assess the pump trigger sprayer scenario. No chemical specific or reasonable surrogate data were available to assess the ready to use wipe and eartag scenarios. This represents a data gap. However, it is assumed that short and intermediate term inhalation exposures and risks to handlers in these scenarios would be lower than exposures and risks from applying with a ready touse aerosol can.

C Short term, intermediate term, and long term risk assessments were completed based on the toxicity endpoints that were identified. HED only anticipates a limited number of scenarios that are long term in nature, including pest control operators and lawn care operators.

C For risk assessments, HED always considers the maximum application rates allowed by labels in its risk assessments in order to be able to consider what is legally possible based on the label. The maximum application rates for cypermethrin are listed in Tables 5a and 5b and those for zeta cypermethrin are listed in Tables 6a and 6b.

C The average occupational workday is assumed to be 8 hours. 22 C The daily areas to be treated were defined for each handler scenario ( in appropriate units) by determining the amount that can be reasonably treated in a single day ( e. g. acres, square feet, cubic feet, gallons, animals). When possible, the assumptions for daily areas treated is taken from the Health Effects Division Science Advisory Committee on Exposure Policy 9: Standard Values for Daily Acres Treated in Agriculture which was revised on July 5, 2000. However, no standard values are available for scenarios involving livestock treatments, or applications using aerosol cans, ready to use foggers, or termiticide injection equipment. Assumptions for these scenarios are based on Health Effects Division estimates and could be further refined from input from affected sectors. The daily areas treated for cypermethrin are listed in Tables 5a and 5b and those for zetacypermethrin are listed in Tables 6a and 6b.

C Unit exposure values were used to estimate exposures to handlers. These unit exposure values were from the Pesticide Handlers Exposure Database ( PHED), the Outdoor Residential Exposure Task Force ( ORETF), the Chemical Manufacturers Association studies, and a proprietary study.

Pesticide Handler Exposure Database ( PHED) Version 1.1 ( August 1998):

Chemical specific data for assessing human exposures during pesticide handling activities were submitted to the Agency in support of one occupational exposure scenario for the reregistration of cypermethrin. It is the policy of HED to combine submitted chemical specific data with that from the Pesticide Handlers Exposure Database ( PHED) Version 1.1 when appropriate to assess handler exposures for regulatory actions. The scenario/ chemical specific study submitted has no corresponding scenario in PHED, therefore, unit exposure values from the study are used to calculate exposure and risk for the use pattern. For all other remaining scenarios, data from PHED were used to complete the assessment.

PHED was designed by a task force of representatives from the U. S. EPA, Health Canada, the California Department of Pesticide regulation, and member companies of the American Crop Protection Association. PHED is a software system consisting of two parts  a database of measured exposure values for workers involved in the handling of pesticides under actual field conditions and a set of computer algorithms used to subset and statistically summarize the selected data. Currently, the database contains values for over 1,700 monitored individuals ( i. e., replicates)

Users select criteria to subset the PHED database to reflect the exposure scenario being evaluated. The subsetting algorithms in PHED are based on the central assumption that the magnitude of handler exposures to pesticides are primarily a function of activity ( e. g., mixing/ loading, applying), formulation type ( e. g., wettable powders, granulars), application method ( e. g., aerial, groundboom), and clothing scenarios ( e. g., gloves, double layer clothing).

Once the data for a given exposure scenario have been selected, the data are normalized ( i. e., divided by) by the amount of pesticide handled resulting in standard unit exposures 23 ( milligrams of exposure per pound of active ingredient handled). Following normalization, the data are statistically summarized. The distribution of exposure values for each body part ( e. g., chest upper arm) is categorized as normal, lognormal, or " other" ( i. e., neither normal nor lognormal). A central tendency value is then selected from the distribution of the exposure values for each body part. These values are the arithmetic mean for normal distributions, the geometric mean for lognormal distributions, and the median for all " other" distributions. Once selected, the central tendency values for each body part are composited into a " best fit" exposure value representing the entire body.

The unit exposure values calculated by PHED generally range from the geometric mean to the median of the selected data set. To add consistency and quality control to the values produced from this system, the PHED Task Force has evaluated all data within the system and has developed a set of grading criteria to characterize the quality of the original study data. The assessment of data quality is based on the number of observations and the available quality control data. These evaluation criteria and the caveats specific to each exposure scenario are summarized in Appendix A. While data from PHED provide the best available information on handler exposures, it should be noted that some aspects of the included studies ( e. g., duration, acres treated, pounds of active ingredient handled) may not accurately represent labeled uses in all cases. HED has developed a series of tables of standard unit exposure values for many occupational scenarios that can be utilized to ensure consistency in exposure assessments. Unit exposures are used which represent different levels of personal protection as described above. Protection factors were used to calculate unit exposure values for varying levels of personal protection if data were not available.

ORETF Handler Studies ( EPA MRID 449722 01)

A report was submitted by the ORETF ( Outdoor Residential Exposure Task Force) that presented exposure data in which the application of various products used on turf by homeowners and lawncare operators ( LCOs) was monitored.

Handgun Studies ( OMA002): A mixer/ loader/ applicator study was performed by the Outdoor Residential Exposure Task Force ( ORETF) using Dacthal as a surrogate compound to determine " generic" exposures to individuals applying a pesticide to turf with a low pressure " nozzle gun" or " handgun" sprayer. Dermal and inhalation exposures were estimated using whole body passive dosimeters and breathing zone air samples on OVS tubes. Inhalation exposure was calculated using an assumed respiratory rate of 17 liters per minute for light work ( NAFTA, 1999), the actual sampling time for each individual, and the pump flow rate. All results were normalized for pounds active ingredient handled. A total of 90 replicates were monitored using 17 different subjects. Four different formulations of dacthal [ 75% wettable powder ( packaged in 4 and 24 pound bags), 75% wettable powder in water soluble bags ( 3 pound bag), 75% water dispersable granules ( 2 pound bag) and 55% liquid flowable ( 2.5 gallon container)] were applied by five different LCOs to actual residential lawns at each site in three different locations ( Ohio, Maryland, and Georgia) for a total of fifteen replicates per formulation. 24 An additional ten replicates at each site were monitored while they performed spray application only using the 75 percent wettable powder formulation. A target application rate of 2 pounds active ingredient was used for all replicates ( actual rate achieved was about 2.2 pounds active ingredient per acre). Each replicate treated a varying number of actual client lawns to attain a representative target of 2.5 acres ( 1 hectare) of turf. The exposure periods averaged five hours twenty one minutes, five hours thirty nine minutes, and six hours twenty four minutes, in Ohio, Maryland and Georgia, respectively. Average time spent spraying at all sites was about two hours. All mixing, loading, application, adjusting, calibrating, and spill clean up procedures were monitored, except for typical end of day clean up activities, e. g. rinsing of spray tank, etc. Dermal exposure was measured using inner and outer whole body dosimeters, hand washes, face/ neck washes, and personal air monitoring devices. All test subjects wore one piece, 100 percent cotton inner dosimeters beneath 100 percent cotton long sleeved shirt and long pants, rubber boots and nitrile gloves. Gloves are typically worn by most LCOs, and required by many pesticide labels for mixing and loading. Overall, residues were highest on the upper and lower leg portions of the dosimeters In general, concurrent lab spikes produced mean recoveries in the range of 78 120 percent, with the exception of OVS sorbent tube sections which produced mean recoveries as low as 65.8 percent. Adjustment for recoveries from field fortifications were performed on each dosimeter section or sample matrix for each study participant, using the mean recovery for the closest field spike level for each matrix and correcting the value to 100 percent. The unit exposure values are presented below. [ Note the data were found to be lognormally distributed. As a result, all exposure values are geometric means.]

Table 7: ORETF LCO Exposure Study Data ( MRID 449722 01): Handgun Sprayer Application Method/ Job Function Study Number Statistic Total Dermal Unit Exposure ( mg/ lb ai)

Statistic Inhalation Unit Exposure ( µ g/ lb ai) 1 Single Layer, No Gloves Single Layer, Gloves Double Layer, Gloves 2 LCO Handgun Spray Mixer/ Loader Applicator OMA002 Liquid Flowable3 [ 15 replicates] Geomean No Data 0.45 0.25 Arithmetic 1.8 LCO Handgun Spray Mixer/ Loader Applicator OMA002 Wettable Powder 3 [ 15 replicates] Geomean No Data 0.80 0.43 Geomean 64 Table 7: ORETF LCO Exposure Study Data ( MRID 449722 01): Handgun Sprayer Application Method/ Job Function Study Number Statistic Total Dermal Unit Exposure ( mg/ lb ai)

Statistic Inhalation Unit Exposure ( µ g/ lb ai) 1 Single Layer, No Gloves Single Layer, Gloves Double Layer, Gloves 2 25 LCO Handgun Spray Mixer/ Loader Applicator OMA002 Wettable Powder in Water Soluble Bags 3 [ 15 replicates] Median No Data 0.64 0.37 Geomean 7.2 1Air concentration ( mg/ m3/ lb ai) calculated using NAFTA ` 99 standard breathing rate of 17 lpm ( 1 m3/ hr) 2Exposure calculated using OPP/ HED 50% protection factor ( PF) for cotton coveralls on torso, arms, legs. 3All commercial handlers wore long pants, long sleeved shirt, nitrile gloves and shoes.

Hose End Sprayer Study ( OMA004): A mixer/ loader/ applicator study was performed by the Outdoor Residential Exposure Task Force ( ORETF) using Diazinon as a surrogate compound to determine " generic" exposures to individuals applying a pesticide to turf with a dial type hose end sprayer. Dermal and inhalation exposures were estimated using whole body passive dosimeters and breathing zone air samples on OVS tubes. Inhalation exposure was calculated using an assumed respiratory rate of 17 liters per minute for light work ( NAFTA, 1999), the actual sampling time for each individual, and the pump flow rate. All results were normalized for pounds active ingredient handled. A total of 30 replicates were monitored throughout the study. Diazinon ( 25% emulsifiable concentrate) was applied by homeowners to actual residential lawns at a site in Maryland. A target application rate of 4 pounds active ingredient was used for all replicates. Each replicate monitored the test subject treating 5,000 ft2 of turf and handling a total of 0.5 lb ai/ replicate. The exposure periods ( mixing/ loading/ applying) averaged seventy five minutes. Dermal exposure was measured using inner and outer whole body dosimeters, hand washes, face/ neck washes, and personal air monitoring devices. In general, concurrent lab spikes produced mean recoveries in the range of 87 103 percent. Adjustment for recoveries from field fortifications ( 79 104 %) were performed on each dosimeter section or sample matrix for each study participant, using the mean recovery for the closest field spike level for each matrix and correcting the value to 100 percent. The unit exposure values are presented below. [ Note the data were found to be lognormally distributed. As a result, all exposure values are geometric means.]

Table 8 reports the dermal unit exposures for the various clothing scenarios and the inhalation unit exposure at baseline ( no respirator). 26 Table 8: ORETF Resident Applicator Exposure Study Data ( MRID 449722 01)

Application Method/ Job Function Study Number Statistic Total Dermal Unit Exposure ( mg/ lb ai)

Statistic Inhalation Unit Exposure ( µ g/ lb ai) 1 Short Pants, Short Sleeves Long Pants, Short Sleeves Long Pants, Long Sleeves Resident Mixer/ loader/ applicator Hose end Sprayer: " Mix your own" 3 OMA004 [ 30 replicates] Geomean 11 6.2 5.6 Geomean 17 1Air concentration ( mg/ m3/ lb ai) calculated using NAFTA ` 99 standard breathing rate of 17 lpm ( 1 m3/ hr). 2 Shorts and short sleeved shirt worn. 3 Long pants, long sleeve shirt, no gloves worn. Short sleeves calculated from dosimeter.

Low Pressure Handwand Study ( OMA005): Applications of Sevin Liquid ® Carbaryl insecticide [ RP 2 liquid ( 21%)] were made by volunteers to two young citrus trees and two shrubs in each replicate that was monitored in the study. The test field was located only in Florida. Twenty ( 20) replicates were monitored using handheld pump sprayers ( low pressure handwands).

Each replicate opened the end use product, added it to the hand held pump and then applied it to the trees and shrubs. After application to two trees and two shrubs dosimeters were collected. Inhalation exposure was monitored with personal air sampling pumps with OVS tubes attached to the shirt collar in the breathing zone. Dermal exposure was assessed by extraction of carbaryl from inner and outer 100 percent cotton dosimeters. The inner and outer dosimeters were segmented into: lower and upper arms, lower and upper legs, front and back torso. No gloves were worn therefore hand exposure was assessed with 400 ml handwash with 0.01 percent Aerosol OT 75 sodium dioctyl sulfosuccinate ( OTS). One hundred percent cotton handkerchiefs wetted with 25 ml OTS were used to wipe face and neck to determine exposure.

Field fortification recoveries for passive dosimeters averaged 88.3 percent for inner and 76.2 percent for outer dosimeters. Face and neck wipe fortifications average 82.5 percent. Handwash and inhalation OVS tube field fortification averaged > 90 percent. Inner and outer dosimeter and face and neck wipe residues were adjusted for field fortification results. Handwash and inhalation residues were not adjusted.

Laboratory method validation for each matrix fell within the acceptable range of 70 to 120 percent. The limit of quantitation ( LOQ) was 1.0 µ g/ sample for all media except the inhalation monitors where the LOQ was 0.01 µ g/ sample. The limit of detection ( LOD) was 0.5 µ g/ sample for all media except the inhalation monitors where the LOQ was 0.005 27 µ g/ sample.

For use in reregistration documents, the dermal exposure was calculated by adding the values from the hand rinses, face/ neck wipes to the outer dosimeter lower legs and lower arms plus the inner dosimeter front and rear torso, upper legs and upper arms. This accounts for the residential handler wearing short sleeved shirt and short pants. The results for the low pressure handwand are summarized in Table 9 below.

Table 9: Unit Exposure Values From ORETF Homeowner Low Pressure Handwand Studies ( MRID 445185 01)

Type Dermal: Long Pants, Long Sleeves ( mg ai/ lb handled) Inhalation ( µ g ai/ lb handled)

Low Pressure Handwand 30.0 3.8 All unit exposure values are geometric means.

Dust Study ( OMA007): The data collected reflect the dermal and respiratory exposure of homeowners mixing, loading and applying Sevin ® 10 Dust, a carbaryl end use product. Applications were made by volunteers to two 18 foot rows of tomatoes and one 18 foot row of cucumber. The only test field was located in Florida. Exposure for each was monitored using 20 replicates which consisted of loading the dusters and applying the dust without gloves.

Each replicate opened the end use product, added it to the application implement, adjusted the setting and applied it to the vegetable rows. After application to the vegetable rows, dosimeters were collected. Inhalation exposure was monitored with personal air sampling pumps with OVS tubes attached to the shirt collar in the breathing zone. Dermal exposure was assessed by extraction of carbaryl from inner and outer 100 percent cotton dosimeters, face/ neck wipes, and glove and hand washes. The inner and outer dosimeters were segmented into: lower and upper arms, lower and upper legs, front and back torso.

Field fortification recoveries for passive dosimeters averaged 84.3 percent for inner and 77.7 percent for outer dosimeters. Face and neck wipe fortifications average 84.8 percent. Handwash and Inhalation OVS tube field fortification averaged > 90 percent. Inner and outer dosimeter and face and neck wipe residues were adjusted for field fortification results. Handwash and inhalation residues were not adjusted.

Laboratory method validation for each matrix fell within the acceptable range of 70 to 120 percent. The limit of quantitation ( LOQ) was 1.0 µ g/ sample for all media except the inhalation monitors where the LOQ was 0.01 µ g/ sample. The limit of detection ( LOD) was 0.5 µ g/ sample for all media except the inhalation monitors where the LOQ was 0.005 µ g/ sample.

Dermal exposure was determined by adding the values from the bare hand rinses, 28 face/ neck wipes to the outer dosimeter lower legs and lower arms plus the inner dosimeter front and rear torso, upper legs, lower legs, lower arms, and upper arms. This accounts for the residential handlers with bare hands wearing short sleeved shirt and short pants. Unit exposures for this scenario are presented below in Table 10. [ Note: The geometric mean values were used for risk assessment purposes.]

Table 10: Unit Exposure Values Obtained From ORETF Homeowner Duster Studies ( MRID 444598 01)

Type Dermal: Long Pants, Long Sleeves ( mg ai/ lb handled) Inhalation ( µ g ai/ lb handled)

Duster 76 620 All unit exposure values are geometric means.

Chemical Manufacturers Association ( CMA) Antimicrobial Exposure Assessment Study:

The CMA exposure study ( December 1992) was a response to March 4, 1987 data call in notice by EPA.

CMA is a generic biocide exposure assessment protocol used to assess potential dermal and/ or inhalation exposure from the application of antimicrobial pesticide products in multiple settings using various application methods. The study examined nine separate antimicrobial pesticides and variety of application methods for a total number of 88 replicates. Dermal exposure was measured with the use of pads attached to the inside and the outside of the applicators clothing. Inhalation exposure was monitored continuously by chemical specific collection media using a personal sampling pump.

The CMA exposure study assessed exposures to individuals who used wipes to apply antimicrobial pesticides. There were six wipe replicates ( no gloves) in the study. Unit exposures for this scenario are presented below in Table 11. While the wipe data from CMA provide the best available information on handler exposures for the wipe and sponge scenarios, it should be noted that some aspects of the study are issues such as: good labor practices were not closely followed, extraction efficiencies were below the minimum level suggested in the guidelines, calibration of the air monitoring equipment resulted in much of the data being less than detection, and the limited number of replicates ( the guidelines recommend 15 replicates).

Table 11: Unit Exposure Values Obtained From CMA Exposure Assessment Study Type Dermal: No gloves ( mg ai/ lb handled) Inhalation ( µ g ai/ lb handled)

Wipe 2870 0.067 All unit exposure values are arithmetic means. 29 Proprietary Data Trigger Sprayer Study ( EPA MRID 410547 01) A total of 15 applicator events during residential applications using a hand operated trigger pump sprayer, attached with an 18 inch hose to half gallon cans containing 0.95 percent propoxur, were completed in this study. The study was completed between October 26 and November 1, 1988 in the Kansas City Missouri metro area. Each person monitored in the study was a Bayer ( the sponsor corporation) employee. Three employees were used to complete all replicates. In each replicate, " each applicator used a separate one half gallon can of Raid for each house. The cap was removed from the top of the can and the hose sprayer was attached by inserting the dip tube into the can and tightening the screw cap. The sprayer was primed by pumping the trigger. The applicator treated the outside of the home in areas where pests were likely to be found, such as screens, door and window frames, foundation walls, patios, porches, stoops, and decks. When the application was completed, the hose sprayer was secured under the handle of the can." The data included in the study indicate that exposure durations ranged from 9 to 21 minutes per replicate and the amount of active ingredient handled ranged from 0.16 to 0.4 oz ( i. e., 0.01 to 0.025 lb ai). Dermal ( nonhand) exposure monitoring during each replicate was completed using gauze sponges held in " aluminized paper holders" with an open sampling surface area of 24.6 cm2 while hand exposures were quantified with the handwash technique ( 2  200 mL aliquots of ethanol per hand for a total volume of 800 mL per person). Inhalation exposures were monitored using standard personal sampling pumps operating a 1 liter per minute with quartz microfiber filters. Samples were collected in this study to represent exposures when a person was wearing normal work clothing ( i. e., long pants and long sleeved shirts) and chemical resistant gloves.

Analysis of propoxur residues was completed with high performance liquid chromatography, post column derivatization, and fluorescence detection. The limits of quantification ( LOQ) were 10 µ g per sample for the handwash solutions, 0.1 µ g/ sample for the inhalation filters, and 0.03 µ g/ cm2 for the dermal patch samples. Field and laboratory recovery data were generated for all media. This study was reviewed in September 1989 under EPA contract 68 02 4254 by Versar. The values used for regulatory purposes have been excerpted from that review ( including recovery results). Average laboratory recovery for all media ranged from 99.2 to 109 percent while the coefficients of variation for each media were generally less than 5 ( i. e., for the patches, the CV = 16.5). Patches and filters were fortified at 1 µ g/ sample while hand rinses were fortified at either 200 or 1000 µ g/ sample. Average field recovery results ranged from 90.3 to 102.2 percent while coefficients of variation also were generally less than 5 ( i. e., inside patch CV= 6.9). Patches were fortified at levels from 1 to 50 µ g/ sample, hand rinses were fortified at 200 µ g/ sample, and filters were fortified at 0.2 µ g/ sample. Unit exposures for this scenario in each are presented below in Table 12. 30 Table 12: Unit Exposure Values Obtained From Propoxur Trigger Pump Sprayer Study ( MRID 410547 01)

Type Dermal ( mg ai/ lb handled) Inhalation ( µ g ai/ lb handled)

Trigger Pump Sprayer 76 1.9 2.1.3 Occupational Handler Exposure and Risk Estimates The occupational handler exposure and risk calculations are presented in this section. Risks were calculated using the Margin of Exposure ( MOE), which is a ratio of the body burden to the toxicological endpoint of concern. Body burden values are calculated by first calculating exposures by considering application parameters ( i. e., rate and area treated) along with unit exposure levels. Exposures were then normalized by body weight and adjusted for absorption factors as appropriate to calculate dose levels ( i. e., body burdens). MOEs were then calculated.

Daily Exposure: The daily exposure, daily dose and hence the risks to handlers were calculated as described below. The first step was to calculate daily exposure ( dermal or inhalation) using the following formula:

Daily Exposure ( mg ai/ day) =

Unit Exposure x Application Rate x Daily amount Treated Where:

Daily Exposure = Amount deposited on the surface of the skin that is available for dermal absorption or amount that is inhaled, also referred to as potential dose ( mg ai/ day); Unit Exposure = Normalized exposure value derived from August 1998 PHED Surrogate Exposure Table and various referenced exposure studies noted above ( mg/ lb ai or : g/ lb ai); Application Rate = Normalized application rate based on a logical unit treatment, such as acres, square feet, gallons, or cubic feet. Maximum values are generally used ( lb ai/ A, lb ai/ sq ft, lb ai/ gal, lb ai/ cu ft); and Daily Area Treated = Normalized application area based on a logical unit treatment such as acres ( A/ day), square feet ( sq ft/ day), gallons per day ( gal/ day), or cubic feet ( cu ft/ day).

Daily Dose: Daily dose ( inhalation or dermal) was calculated by normalizing the daily dermal or inhalation exposure value by body weight and accounting for an inhalation or dermal absorption ( i. e., a biologically available dose resulting from dermal or inhalation exposure was then calculated). For adult handlers using cypermethrin or zeta cypermethrin, an average adult body weight of 70 kg was used for all exposure scenarios because the endpoints were not sexspecific No dermal penetration/ absorption studies are available for cypermethrin or zetacypermethrin A dermal absorption value of 2.5% may be estimated by comparing the maternal 31 LOAEL of 25 mg/ kg/ day from the developmental study in the rat and the NOAEL ( highest dose tested) of 1000 mg/ kg/ day from the 21 day dermal study in the rat. Since there was no common endpoint because no effects were observed in the 21 day dermal study in the rat, this is considered to be a worst case estimate. No inhalation absorption factor is necessary, since the inhalation endpoints are based on an inhalation study. Daily dose was calculated using the following formula:

Daily dermal or inhalation dose ( mg/ kg/ day) =

daily exposure / body weight x absorption factor ( if needed)

Where:

Average Daily Dose = The amount as absorbed dose received from exposure to a pesticide in a given scenario ( mg pesticide active ingredient per kg body weight per day, also referred to as ADD); Daily Exposure = Amount deposited on the surface of the skin that is available for dermal absorption or amount that is inhaled, also referred to as potential dose ( mg ai/ day); Absorption Factor = A measure of the flux or amount of chemical that crosses a biological boundary such as the skin or lungs (% of the total available absorbed); and Body Weight = Body weight determined to represent the population of interest in a risk assessment ( kg).

Margins of Exposure: Finally, the calculations of daily dermal dose and daily inhalation dose received by handlers were then compared to the appropriate endpoint ( i. e., NOAEL) to assess the total risk to handlers for each exposure route within the scenarios. Long term dermal MOEs were calculated using a NOAEL of 6 mg/ kg/ day and inhalation MOEs for all durations were calculated using a NOAEL of 2.7 mg/ kg/ day ( Table 1). All MOE values were calculated separately for dermal and inhalation exposure levels using the formula below:

Dermal or Inhalation MOE = Daily Dose ( mg/ kg/ day) / NOAEL( mg/ kg/ day)

Where:

MOE = Margin of exposure, value used by the Agency to represent risk or how close a chemical exposure is to being a concern ( unitless); ADD = ( Average Daily Dose) or the amount as absorbed dose received from exposure to a pesticide in a given scenario ( mg pesticide active ingredient per kg body weight per day); and NOAEL = Dose level in a toxicity study, where no observed adverse effects occurred ( NOAEL) in the study or the lowest dose level where an adverse effect occurred.

The target MOEs for long term occupational workers are 100 for dermal and 300 for inhalation risk. The adverse effects seen in both the dermal and inhalation studies were loss of body weight; therefore, the MOEs were combined to identify a total aggregated risk index ( ARI). 32 An ARI was used since the target MOE values for inhalation and dermal exposure were different. The target ARI is 1, therefore, ARIs of less than 1 are risks of concern.

Long term aggregate risk index ( ARI) = 1/(( 1/( calculated dermal MOE/ target MOE ( 100)) + ( 1/( calculated inhalation MOE/ target MOE ( 300))). The target level is 1.

Risk Summary:

All of the risk calculations for occupational cypermethrin and zeta cypermethrin handlers completed in this assessment are included in Appendix A.

Occupational Risk Summary:

Short and Intermediate term Risk Summary Short and intermediate term dermal exposures and risks were not assessed for cypermethrin and zeta cypermethrin, since no short or intermediate term dermal endpoint was identified.

Cypermethrin Cypermethrin inhalation risks are summarized in Table 13 below.

When data were available to assess risks, short and intermediate term inhalation risks to occupational handlers are below the Agency's level of concern for risk assessments ( i. e., MOE $

100) at baseline ( i. e., no respirator) for all the formulations, except wettable powder formulations. For several scenarios involving wettable powder formulation, risks are above HED's level of concern ( i. e., MOEs are less than 100) at baseline ( i. e., no respirator). The addition of a dust/ mist filtering respirator reduces the risks to below HED's level of concern for all these scenarios, except mixing/ loading to support aerial or groundboom applications to agricultural uncultivated areas, fencerows, and hedgerows and mixing/ loading to support aerial applications to sodfarms. For these three scenarios, engineering controls ( i. e., water soluble packaging) are necessary to reduce the inhalation risks to below HED's level of concern. EPA has insufficient data to assess exposures to pilots in open cockpits. Inhalation risks to pilots in enclosed cockpits ( engineering control scenario) were not a concern for all agricultural crop scenarios. No data are available to assess inhalation risks during the application of impregnated eartags to horses, however, the risks are expected to be well below the inhalation risks ( MOE = 15,000) from applications using a ready to use aerosol can ( considered to represent a worst case exposure scenario for applications of impregnated eartags to horses).

Short and intermediate term dermal risks were not assessed for occupational handlers, since no short or intermediate term dermal endpoint was identified.

Zeta Cypermethrin 33 Zeta cypermethrin inhalation risks are summarized in Table 14 below.

When data were available to assess risks, short and intermediate term inhalation risks to occupational handlers are below the Agency's level of concern for risk assessments ( i. e., MOE $

100) at baseline ( i. e., no respirator). EPA has insufficient data to assess exposures to pilots in open cockpits. Inhalation risks to pilots in enclosed cockpits ( engineering control scenario) were not a concern for all agricultural crop scenarios. No data are available to assess inhalation risks during the application of dusts via a mechanical duster and application of ready to use eartags.

Short and intermediate term dermal risks were not assessed for occupational handlers, since no short or intermediate term dermal endpoint was identified. 34 Table 13: Cypermethrin Occupational Handler Short and Intermediate Term Inhalation Risks Exposure Scenario Crop or Target Application Ratea ( lb ai/ unit) Amount Handled Dailyb Baseline Inhalation MOEc Dust/ Mist Respirator Inhalation MOEd Engineering Control Inhalation MOEe Mixer/ Loader Mixing/ Loading Liquid Concentrates for Aerial Application ( 1a) agricultural uncultivated areas; fencerows, hedgerows 3.4 lb ai/ acre 350 acres 130 660 1,900 cotton 0.1 lb ai/ acre 1200 acres 1,300 6,600 19,000 broccoli, broccoli raab, brussel sprouts, bok choy, cabbage,

cauliflower, cavalo broccolo, Chinese broccoli, Chinese cabbage,

collards, head lettuce, kale, kohlrabi mizuna, mustard greens,

mustard spinach, pecans, rape greens 0.1 lb ai/ acre 350 acres 4,500 23,000 65,000 Mixing/ Loading Liquid Concentrates for Chemigation Application ( 1b) broccoli, broccoli raab, brussel sprouts, bok choy, cabbage,

cauliflower, cavalo broccolo, Chinese broccoli, Chinese cabbage,

collards, cotton, head lettuce, kale, kohlrabi mizuna, mustard greens, mustard spinach, pecans, rape greens 0.1 lb ai/ acre 350 acres 4,500 23,000 65,000 Mixing/ Loading Liquid Concentrates for Groundboom Application ( 1c) agricultural uncultivated areas; fencerows, hedgerows 3.4 lb ai/ acre 80 acres 580 2,900 8,400 ornamental plants 3.4 lb ai/ acre 40 acres 1,200 5,800 17,000 cotton 0.1 lb ai/ acre 200 acres 7,900 39,000 110,000 broccoli, broccoli raab, brussel sprouts, bok choy, cabbage,

cauliflower, cavalo broccolo, Chinese broccoli, Chinese cabbage,

collards, head lettuce, kale, kohlrabi mizuna, mustard greens,

mustard spinach, pecans, rape greens 0.1 lb ai/ acre 80 acres 20,000 98,000 280,000 Mixing/ Loading Liquid Concentrates for Airblast Application ( 1d) pecans 0.1 lb ai/ acre 40 acres 39,000 200,000 570,000 ornamental plants 3.4 lb ai/ acre 20 acres 2,300 12,000 33,000 Mixing/ Loading Wettable Powders for Aerial Application ( 2a) agricultural uncultivated areas; fencerows, hedgerows 3.4 lb ai/ acre 350 acres 4 18 660 sodfarms 0.74 lb ai/ acre 350 acres 17 85 3,000 cotton 0.1 lb ai/ acre 1200 acres 37 180 6,600 Table 13: Cypermethrin Occupational Handler Short and Intermediate Term Inhalation Risks Exposure Scenario Crop or Target Application Ratea ( lb ai/ unit) Amount Handled Dailyb Baseline Inhalation MOEc Dust/ Mist Respirator Inhalation MOEd Engineering Control Inhalation MOEe 35 Mixing/ Loading Wettable Powders for Aerial Application ( 2a) ( cont.) broccoli, broccoli raab, brussel sprouts, bok choy, cabbage,

cauliflower, cavalo broccolo, Chinese broccoli, Chinese cabbage,

collards, head lettuce, kale, kohlrabi mizuna, mustard greens,

mustard spinach, pecans, rape greens, 0.1 lb ai/ acre 350 acres 130 630 23,000 Mixing/ Loading Wettable Powders for Chemigation Application ( 2b) broccoli, broccoli raab, brussel sprouts, bok choy, cabbage,

cauliflower, cavalo broccolo, Chinese broccoli, Chinese cabbage,

collards, cotton, head lettuce, kale, kohlrabi mizuna, mustard greens, mustard spinach, pecans, rape greens, 0.1 lb ai/ acre 350 acres 130 630 23,000 Mixing/ Loading Wettable Powders for Groundboom Application ( 2c) agricultural uncultivated areas; fencerows, hedgerows 3.4 lb ai/ acre 80 acres 16 81 2,900 ornamental plants 3.4 lb ai/ acre 40 acres 32 160 5,800 sodfarms 0.74 lb ai/ acre 80 acres 74 370 13,000 cotton 0.1 lb ai/ acre 200 acres 220 1,100 39,000 broccoli, broccoli raab, brussel sprouts, bok choy, cabbage,

cauliflower, cavalo broccolo, Chinese broccoli, Chinese cabbage,

collards, head lettuce, kale, kohlrabi mizuna, mustard greens,

mustard spinach, rape greens 0.1 lb ai/ acre 80 acres 550 2,700 98,000 Mixing/ Loading Wettable Powders for Airblast Application ( 2d) ornamental plants 3.4 lb ai/ acre 20 acres 65 320 12,000 pecans 0.1 lb ai/ acre 40 acres 1,100 5,500 200,000 Applicator Applying Sprays with an Airplane ( 3) agricultural uncultivated areas; fencerows, hedgerows 3.4 lb ai/ acre 350 acres see Eng. Controls see Eng. Controls 2,300 sodfarms 0.74 lb ai/ acre 350 acres see Eng. Controls see Eng. Controls 11,000 cotton 0.1 lb ai/ acre 1200 acres see Eng. Controls see Eng. Controls 23,000 Table 13: Cypermethrin Occupational Handler Short and Intermediate Term Inhalation Risks Exposure Scenario Crop or Target Application Ratea ( lb ai/ unit) Amount Handled Dailyb Baseline Inhalation MOEc Dust/ Mist Respirator Inhalation MOEd Engineering Control Inhalation MOEe 36 Applying Sprays with an Airplane ( 3)

( cont.) broccoli, broccoli raab, brussel sprouts, bok choy, cabbage,

cauliflower, cavalo broccolo, Chinese broccoli, Chinese cabbage,

collards, head lettuce, kale, kohlrabi mizuna, mustard greens,

mustard spinach, pecans, rape greens 0.1 lb ai/ acre 350 acres see Eng. Controls see Eng. Controls 79,000 Applying Sprays with Groundboom Application ( 4) agricultural uncultivated areas; fencerows, hedgerows 3.4 lb ai/ acre 80 acres 940 4,600 16,000 ornamental plants 3.4 lb ai/ acre 40 acres 1,900 9,300 32,000 sodfarms 0.74 lb ai/ acre 80 acres 4,300 21,000 74,000 cotton 0.1 lb ai/ acre 200 acres 13,000 63,000 220,000 broccoli, broccoli raab, brussel sprouts, bok choy, cabbage,

cauliflower, cavalo broccolo, Chinese broccoli, Chinese cabbage,

collards, head lettuce, kale, kohlrabi mizuna, mustard greens,

mustard spinach, rape greens 0.1 lb ai/ acre 80 acres 32,000 160,000 550,000 Applying Sprays with an Airblast ( 5) ornamental plants 3.4 lb ai/ acre 20 acres 620 3,100 6,200 pecans 0.1 lb ai/ acre 40 acres 11,000 53,000 110,000 Flagger Flagging for Aerial Sprays ( 6) agricultural uncultivated areas; fencerows, hedgerows 3.4 lb ai/ acre 350 acres 450 2,300 23,000 sodfarms 0.74 lb ai/ acre 350 acres 2,100 10,000 100,000 broccoli, broccoli raab, brussel sprouts, bok choy, cabbage,

cauliflower, cavalo broccolo, Chinese broccoli, Chinese cabbage,

collards, cotton, head lettuce, kale, kohlrabi mizuna, mustard greens, mustard spinach, pecans, rape greens 0.1 lb ai/ acre 350 acres 15,000 77,000 770,000 Mixer/ Loader/ Applicator Mixing/ Loading/ Applying Liquid Concentrates with a Low Pressure Handwand ( 7) residential, commercial and industrial lawns 0.44 lb ai/ acre 5 acres 2,900 14,000 Not Feasible Table 13: Cypermethrin Occupational Handler Short and Intermediate Term Inhalation Risks Exposure Scenario Crop or Target Application Ratea ( lb ai/ unit) Amount Handled Dailyb Baseline Inhalation MOEc Dust/ Mist Respirator Inhalation MOEd Engineering Control Inhalation MOEe 37 Mixing/ Loading/ Applying Liquid Concentrates with a Low Pressure Handwand ( 7) ( cont.) Termites applications to soil and sides of buildings near to ground,

building perimeters, masonry voids, and standing wood in uninhabited areas at residential, commercial and industrial sites 0.05 lb ai/ gallon 40 gallons 3,200 16,000 Not Feasible Termites applications to preconstruction lumber and logs, and to soil under firewood 0.041 lb ai/ gallon 40 gallons 3,800 19,000 Not Feasible Non termite applications to indoor and outdoor surfaces at residential, commercial and industrial sites, animal premises, and greenhouses; applications to horses 0.017 lb ai/ gallon 40 gallons 9,300 46,000 Not Feasible ornamental plants; termite applications to standing wood in uninhabited areas at residential, commercial and industrial sites 0.008 lb ai/ gallon 40 gallons 20,000 98,000 Not Feasible Mixing/ Loading/ Applying Liquid Concentrates with a Paintbrush ( 8) Termites applications to soil and sides of buildings near to ground,

building perimeters, masonry voids, and standing wood in uninhabited areas at residential, commercial and industrial sites 0.05 lb ai/ gallon 5 gallons 2,700 14,000 Not Feasible Termites applications to preconstruction lumber and logs, and to soil under firewood 0.041 lb ai/ gallon 5 gallons 3,300 16,000 Not Feasible Non termite applications to indoor and outdoor surfaces at residential, commercial and industrial sites, animal premises, and greenhouses; 0.017 lb ai/ gallon 5 gallons 7,900 40,000 Not Feasible Mixing/ Loading/ Applying Liquid Concentrates with a Handheld Handgun ( ORETF) ( 9) agricultural uncultivated areas; fencerows, hedgerows; ornamental plants; potting soil, topsoil 3.4 lb ai/ acre 5 acres 6,200 31,000 Not Feasible residential, commercial and industrial lawns 0.44 lb ai/ acre 5 acres 48,000 240,000 Not Feasible Mixing/ Loading/ Applying Liquid Concentrates with an Termiticide Injector ( 10) Termites: trees, utility poles, fenceposts, building voids 0.05 lb ai/ gallon 500 gallons 3,400 17,000 Not Feasible Mixing/ Loading/ Applying Wettable Powders with a Low Pressure Handwand ( 11) residential, commercial and industrial lawns 0.6 lb ai/ acre 5 acres 57 290 Not Feasible Termites applications to soil and sides of buildings near to ground,

building perimeters, masonry voids, and standing wood in uninhabited areas at residential, commercial and industrial sites 0.05 lb ai/ gallon 40 gallons 86 430 Not Feasible fire ant mounds 0.033 lb ai/ gallon 40 gallons 130 650 Not Feasible Table 13: Cypermethrin Occupational Handler Short and Intermediate Term Inhalation Risks Exposure Scenario Crop or Target Application Ratea ( lb ai/ unit) Amount Handled Dailyb Baseline Inhalation MOEc Dust/ Mist Respirator Inhalation MOEd Engineering Control Inhalation MOEe 38 Mixing/ Loading/ Applying Wettable Powders with a Low Pressure Handwand ( 11) ( cont.) Non termite applications to indoor and outdoor surfaces at residential, commercial and industrial sites, animal premises, and greenhouses; applications to horses 0.017 lb ai/ gallon 40 gallons 250 1,300 Not Feasible ornamental plants; termite applications to standing wood in uninhabited areas at residential, commercial and industrial sites 0.008 lb ai/ gallon 40 gallons 540 2,700 Not Feasible Mixing/ Loading/ Applying Wettable Powders with a Paintbrush ( using PHED liquid paintbrush) ( 12) Termites applications to soil and sides of buildings near to ground,

building perimeters, masonry voids, and standing wood in uninhabited areas at residential, commercial and industrial sites 0.05 lb ai/ gallon 5 gallons 2,700 14,000 Not Feasible Termites applications to preconstruction lumber and logs, and to soil under firewood 0.041 lb ai/ gallon 5 gallons 3,300 16,000 Not Feasible Non termite applications to indoor and outdoor surfaces at residential, commercial and industrial sites, animal premises, and greenhouses; 0.017 lb ai/ gallon 5 gallons 7,900 40,000 Not Feasible Mixing/ Loading/ Applying Wettable Powders Formulations with a Handheld Handgun ( ORETF) ( 13) agricultural uncultivated areas; fencerows, hedgerows; ornamental plants; potting soil, topsoil 3.4 lb ai/ acre 5 acres 170 870 Not Feasible residential, commercial and industrial lawns 0.6 lb ai/ acre 5 acres 980 4,900 Not Feasible Mixing/ Loading/ Applying Wettable Powders in Water Soluble Packaging with a Handheld Handgun ( ORETF) ( 14) agricultural uncultivated areas; fencerows, hedgerows; ornamental plants; potting soil, topsoil 3.4 lb ai/ acre 5 acres 1,500 7,700 Not Feasible residential, commercial and industrial lawns 0.6 lb ai/ acre 5 acres 8,800 44,000 Not Feasible Applying Ready to Use Formulations via RTU Tag ( 15) cattle 0.003 lb ai/ 2 ear tags 100 and 1000 cattle No Data No Data Not Feasible Applying Ready to Use Formulations with Pump Trigger Sprayers ( 16) horses 0.017 lb ai/ gallon 1 gallon 90,000 450,000 Not Feasible Applying Ready to Use Formulations with Wipes ( 17) horses 0.00041 lb ai/ wipe 500 horses 14,000,000 69,000,000 Not Feasible 50 horses 140,000,00 0 690,000,000 Not Feasible Applying Ready to Use Formulations with Aerosol Cans ( 18) Non termite applications to indoor and outdoor surfaces at residential, commercial and industrial sites, animal premises, and greenhouses; 0.005 lb ai/ 16 oz can 2 cans 15,000 73,000 Not Feasible Table 13: Cypermethrin Occupational Handler Short and Intermediate Term Inhalation Risks Exposure Scenario Crop or Target Application Ratea ( lb ai/ unit) Amount Handled Dailyb Baseline Inhalation MOEc Dust/ Mist Respirator Inhalation MOEd Engineering Control Inhalation MOEe 39 Applying Ready to Use Formulations with Fogger ( 19) Non termite applications to indoor spaces at residential, commercial and industrial sites, animal premises, and greenhouses 0.0014 lb ai/ fogger 4 foggers 26,000 130,000 Not Feasible Footnotes a Application rates are the maximum application rates determined from EPA registered labels for cypermethrin.

b Amount handled per day values are EPA estimates of acreage treated or gallons applied based on Exposure SAC Policy # 9 " Standard Values for Daily Acres Treated in Agriculture".

c Baseline inhalation MOE = short and intermediate term NOAEL ( 2.7 mg/ kg/ day) / baseline inhalation dose ( mg/ kg/ day) and represents no respiratory protection.

d 80% PPE R inhalation MOE = short and intermediate term NOAEL ( 2.7 mg/ kg/ day) / 80 percent PPE R inhalation dose ( mg/ kg/ day) and represents use of a dust mist respirator.

Dose is calculated using an 80 percent protection factor applied to baseline inhalation exposure values found in the PHED Surrogate Exposure Guide.

e Engineering control inhalation MOE = short and intermediate term NOAEL ( 2.7 mg/ kg/ day) / engineering control inhalation dose ( mg/ kg/ day) and represents:

1a, 1b, 1c, 1d: closed mixing and loading 2a, 2b, 2c, 2d: water soluble packaging 3: enclosed cockpit 4, 5, 6: enclosed cab 40 Table 14: Zeta Cypermethrin Occupational Handler Short and Intermediate Term Risks Exposure Scenario Crop or Target Application Ratea Area Treated Dailyb Baseline Inhalation MOEc Dust/ Mist Respirator Inhalation MOEd Engineering Control Inhalation MOEe Mixer/ Loader Mixing/ Loading Liquid Concentrates for Aerial Applications ( 1a) Alfalfa, Alfalfa grown for seed, Corn, sweet, field, pop, and field grown for seed; Cotton ( foliar use), Rice, Soybeans,

Wheat, and Triticale 0.05 lb ai/ acre 1200 acres 2,600 13,000 38,000 Leafy Brassica Greens, Head and Stem Brassica Vegetables,

Bulb Vegetables, Fruiting Vegetables ( except cucurbits), Leafy Vegetables ( except Brassica), Succulent Edible Podded Peas,

Succulent Edible Podded Beans, Head Lettuce, Pecans, Grain Sorghum and Millet, Sugarbeets, Sugarcane 0.05 lb ai/ acre 350 acres 9,000 45,000 130,000 Mixing/ Loading Liquid Concentrates for Chemigation Applications ( 1b) Alfalfa, Alfalfa grown for seed, Corn, sweet, field, pop, and field grown for seed; Cotton ( foliar use), Rice, Soybeans,

Wheat, and Triticale 0.05 lb ai/ acre 350 acres 9,000 45,000 130,000 Leafy Brassica Greens, Head and Stem Brassica Vegetables,

Bulb Vegetables, Fruiting Vegetables ( except cucurbits), Leafy Vegetables ( except Brassica), Succulent Edible Podded Peas,

Succulent Edible Podded Beans, Head Lettuce, Pecans, Grain Sorghum and Millet, Sugarbeets, Sugarcane 0.05 lb ai/ acre 350 acres 9,000 45,000 130,000 Mixing/ Loading Liquid Concentrates for Groundboom Applications ( 1c) Alfalfa, Alfalfa grown for seed, Corn, sweet, field, pop, and field grown for seed; Cotton ( foliar use), Rice, Soybeans,

Wheat, and Triticale 0.05 lb ai/ acre 200 acres 16,000 79,000 230,000 Leafy Brassica Greens, Head and Stem Brassica Vegetables,

Bulb Vegetables, Fruiting Vegetables ( except cucurbits), Leafy Vegetables ( except Brassica), Succulent Edible Podded Peas,

Succulent Edible Podded Beans, Head Lettuce, Grain Sorghum and Millet, Sugarbeet, Sugarcane 0.05 lb ai/ acre 80 acres 39,000 200,000 570,000 Mixing/ Loading Liquid Concentrates for Airblast Applications ( 1d) Pecans 0.05 lb ai/ acre 40 acres 79,000 390,000 1,100,000 Table 14: Zeta Cypermethrin Occupational Handler Short and Intermediate Term Risks Exposure Scenario Crop or Target Application Ratea Area Treated Dailyb Baseline Inhalation MOEc Dust/ Mist Respirator Inhalation MOEd Engineering Control Inhalation MOEe 41 Loading Dusts into Mechanical Duster or Dust Bags ( using PHED mixing/ loading wettable powders data) ( 2) Livestock ( beef & dairy cattle, sheep, goats, horses) 0.00094 lb ai/ animal 1000 animals 4,700 23,000 Not Feasible Applicator Applying Sprays via Aerial Equipment ( 3) Alfalfa, Alfalfa grown for seed, Corn, sweet, field, pop, and field grown for seed; Cotton ( foliar use), Rice, Soybeans,

Wheat, and Triticale 0.05 lb ai/ acre 1200 acres No Data No Data 46,000 Leafy Brassica Greens, Head and Stem Brassica Vegetables,

Bulb Vegetables, Fruiting Vegetables ( except cucurbits), Leafy Vegetables ( except Brassica), Succulent Edible Podded Peas,

Succulent Edible Podded Beans, Head Lettuce, Pecans, Grain Sorghum and Millet, Sugarbeet, Sugarcane 0.05 lb ai/ acre 350 acres No Data No Data 160,000 Applying Sprays via Groundboom Equipment ( 4) Alfalfa, Alfalfa grown for seed, Corn, sweet, field, pop, and field grown for seed; Cotton ( foliar use), Rice, Soybeans,

Wheat, and Triticale 0.05 lb ai/ acre 200 acres 26,000 130,000 440,000 Leafy Brassica Greens, Head and Stem Brassica Vegetables,

Bulb Vegetables, Fruiting Vegetables ( except cucurbits), Leafy Vegetables ( except Brassica), Succulent Edible Podded Peas,

Succulent Edible Podded Beans, Head Lettuce, Grain Sorghum and Millet, Sugarbeet, Sugarcane 0.05 lb ai/ acre 80 acres 64,000 320,000 1,100,000 Applying Sprays via Airblast Equipment ( 5) Pecans 0.05 lb ai/ acre 40 acres 21,000 110,000 210,000 Applying Dusts via Mechanical Duster ( 6) Livestock ( beef & dairy cattle, sheep, goats, horses) 0.00094 lb ai/ animal 1000 animals No Data No Data No Data Table 14: Zeta Cypermethrin Occupational Handler Short and Intermediate Term Risks Exposure Scenario Crop or Target Application Ratea Area Treated Dailyb Baseline Inhalation MOEc Dust/ Mist Respirator Inhalation MOEd Engineering Control Inhalation MOEe 42 Flagger Flagging for Aerial Spray Applications ( 7) Alfalfa, Alfalfa grown for seed, Corn, sweet, field, pop, and field grown for seed; Cotton ( foliar use), Rice, Soybeans,

Wheat, Triticale, Leafy Brassica Greens, Head and Stem Brassica Vegetables, Bulb Vegetables, Fruiting Vegetables ( except cucurbits), Leafy Vegetables ( except Brassica),

Succulent Edible Podded Peas, Succulent Edible Podded Beans,

Head Lettuce, Pecans, Grain Sorghum and Millet, Sugarbeet,

Sugarcane 0.05 lb ai/ acre 350 acres 31,000 150,000 1,500,000 Mixer/ Loader/ Applicator Mixing/ Loading/ Applying Liquid Concentrates with Low Pressure Handwand ( PHED) ( 8) Indoor surfaces 0.0044 lb ai/ gallon 40 gallons 36,000 180,000 Not Feasible Residential Lawns and Turfgrass at Commercial Sites 0.3 lb ai/ acre 5 acres 4,200 21,000 Not Feasible Outdoor surfaces 0.001 lb ai/ gallon 40 gallons 160,000 790,000 Not Feasible Mixing/ Loading/ Applying Liquid Concentrates with a Handgun Sprayer ( LCO ORETF data) ( 9) residential lawns 0.3 lb ai/ acre 5 acres 70,000 350,000 Not Feasible outdoor surfaces, surfaces of buildings, porches, screens,

window frames, eaves, patios, lawn area adjacent to or around private homes, duplexes, townhouses, condominiums, house trailers apartment complexes, carports, garages, fence lines,

storage sheds, barns, and other residential structures plus commercial, industrial, institutional buildings, vegetation,

refuse dumps, garages, and other outdoor surfaces 0.4356 lb ai/ acre 5 acres 48,000 240,000 Not Feasible Applying Dusts via Shaker Can ( MRID 444598 01) ( 10) Livestock ( beef & dairy cattle, sheep, goats, horses) 0.00094 lb ai/ animal 100 animals 3,200 16,000 Not Feasible Table 14: Zeta Cypermethrin Occupational Handler Short and Intermediate Term Risks Exposure Scenario Crop or Target Application Ratea Area Treated Dailyb Baseline Inhalation MOEc Dust/ Mist Respirator Inhalation MOEd Engineering Control Inhalation MOEe 43 Mixing/ Loading/ Applying Liquid Concentrates with a Watering Can ( using ORETF residential hose end data) ( 12) outdoor surfaces ( ant mounds) 0.006 lb ai/ mound 40 mounds 46,000 230,000 Not Feasible Mixing/ Loading/ Applying Liquid Concentrates with a Paint Brush ( 13) outdoor surfaces ( general) 0.001 lb ai/ gallon 5 gallons 140,000 680,000 Not Feasible Applying Ready to Use Ear Tags ( 14) livestock ( cattle) 0.004 lb ai/ 2 ear tags/ cattle 100 &

1000 cattle No Data No Data Not Feasible livestock ( cattle) 0.003 lb ai/ 1 ear tag/ cattle 100 &

1000 cattle No Data No Data Not Feasible Loading Dusts into Self

Applying Dust Bags ( using PHED mixing/ loading wettable powders data) ( 15) Livestock ( beef & dairy cattle, sheep, goats, horses) 0.00094 lb ai/ animal 1000 animals 4,700 23,000 Not Feasible Footnotes a Application rates are the maximum application rates determined from EPA registered labels for Zeta Cypermethrin.

b Amount handled per day values are HED estimates of acres, square feet, or cubic feet treated or gallons applied based on Exposure SAC SOP # 9 " Standard Values for Daily Acres Treated in Agriculture," industry sources, and HED estimates.

c Baseline inhalation: no respirator.

d PPE inhalation: assumes a dust/ mist removing quarter face style respirator providing an 80% protection factor ( PF5)

e Eng Controls Inhalation: Closed mixing/ loading system, enclosed cab, or enclosed cockpit. 44 Chronic Risk Summary Cypermethrin A few occupational handler exposure scenarios may be considered long term, including applications to residential, commercial, and industrial turf by commercial lawn care operators and applications in and around residential, commercial, and industrial premises by commercial pest control operators. Aggregated long term dermal and inhalation risks are below HED's level of concern for all scenarios involving liquid formulations at baseline attire or with the addition of chemical resistant gloves to baseline attire. Aggregated long term dermal and inhalation risks are below HED's level of concern for all scenarios involving wettable powder formulations at baseline attire or with the addition of chemical resistant gloves to baseline attire, except mixing/ loading/ applying wettable powders with a low pressure handwand sprayer. Risks were reduced to below HED's level of concern with the addition of a dust/ mist respirator and chemical resistant gloves to baseline attire for these scenarios, except for applications to residential, commercial and industrial lawns ( 0.6 lb ai/ A). Even with the addition of maximum personal protection equipment ( PPE), combined long term dermal and inhalation risks for mixing/ loading/ applying with low pressure handwand sprayer to residential, commercial and industrial lawns were still above the HED's level of concern ( i. e, ARI < 1).

Zeta Cypermethrin A few occupational handler exposure scenarios may be considered long term, including applications to residential, commercial, and industrial turf by commercial lawn care operators and applications by pest control operators. When data were available to assess risks, long term risks to occupational handlers were below the Agency's level of concern for risks ( i. e, ARI < 1) at baseline attire ( i. e., long sleeve shirt, long pants, shoes, socks, and no respirator). For mixing/ loading/ applying liquid concentrates with a handgun sprayer, no data are available to assess dermal exposures at baseline attire. However, the combined long term risks were below HED's level of concern with the addition of chemical resistant gloves to baseline attire. 45 Table 15: Cypermethrin Long Term Occupational Handler Summary Exposure Scenario Crop or Target Application Ratea ( lb ai/ unit) Amount Handled Dailyb Long Term Baseline Dermal +

Baseline Inhalation ARIc Long Term PPEGloves Dermal +

Baseline Inhalation ARId Long Term PPEGloves Dermal +

Dust/ Mist Respirator Inhalation ARIe Mixer/ Loader/ Applicator Mixing/ Loading/ Applying Liquid Concentrates with a Low Pressure Handwand ( 1) residential, commercial and industrial lawns 0.44 lb ai/ acre 5 acre 0.71 9.1 38 Termites applications to soil and sides of buildings near to ground, building perimeters, masonry voids,

and standing wood in uninhabited areas at residential,

commercial and industrial sites 0.05 lb ai/ gallon 40 gallons 0.78 10 41 Termites applications to preconstruction lumber and logs, and to soil under firewood 0.041 lb ai/ gallon 40 gallons 0.95 12 50 Non termite applications to indoor and outdoor surfaces at residential, commercial and industrial sites,

animal premises, and greenhouses; 0.017 lb ai/ gallon 40 gallons 2.3 29 120 ornamental plants; termite applications to standing wood in uninhabited areas at residential, commercial and industrial sites 0.008 lb ai/ gallon 40 gallons 4.9 62 260 Mixing/ Loading/ Applying Liquid Concentrates with a Paintbrush ( 2) Termites applications to soil and sides of buildings near to ground, building perimeters, masonry voids,

and standing wood in uninhabited areas at residential,

commercial and industrial sites 0.05 lb ai/ gallon 5 gallons 2.6 6.8 17 Termites: preconstruction lumber and logs, soil under firewood 0.041 lb ai/ gallon 5 gallons 3.2 8.3 21 Non termite applications to indoor and outdoor surfaces at residential, commercial and industrial sites,

animal premises, and greenhouses; 0.017 lb ai/ gallon 5 gallons 7.8 20 51 Mixing/ Loading/ Applying Liquid Concentrates with a Handheld Handgun ( ORETF)

( 3) agricultural uncultivated areas; fencerows, hedgerows;

ornamental plants; potting soil, topsoil 3.4 lb ai/ acre 5 acres no baseline dermal data 11 18 residential, commercial and industrial lawns 0.44 lb ai/ acre 5 acres no baseline dermal data 82 140 Table 15: Cypermethrin Long Term Occupational Handler Summary Exposure Scenario Crop or Target Application Ratea ( lb ai/ unit) Amount Handled Dailyb Long Term Baseline Dermal +

Baseline Inhalation ARIc Long Term PPEGloves Dermal +

Baseline Inhalation ARId Long Term PPEGloves Dermal +

Dust/ Mist Respirator Inhalation ARIe 46 Mixing/ Loading/ Applying Liquid Concentrates with a Termiticide Injector ( 4) Termites: trees, utility poles, fenceposts, building voids 0.05 lb ai/ gallon 500 gallons no baseline dermal data 7.1 18 Mixing/ Loading/ Applying Wettable Powders with a Low Pressure Handwand ( 5) residential, commercial and industrial lawns 0.6 lb ai/ acre 5 acres no baseline dermal data 0.19 0.83 Termites applications to soil and sides of buildings near to ground, building perimeters, masonry voids,

and standing wood in uninhabited areas at residential,

commercial and industrial sites 0.05 lb ai/ gallon 40 gallons no baseline dermal data 0.28 1.2 fire ant mounds 0.033 lb ai/ gallon 40 gallons no baseline dermal data 0.42 1.9 Non termite applications to indoor and outdoor surfaces at residential, commercial and industrial sites,

animal premises, and greenhouses; applications to horses 0.017 lb ai/ gallon 40 gallons no baseline dermal data 0.82 3.7 ornamental plants; termite applications to standing wood in uninhabited areas at residential, commercial and industrial sites 0.008 lb ai/ gallon 40 gallons no baseline dermal data 1.7 7.8 Mixing/ Loading/ Applying Wettable Powders with a Paintbrush ( using PHED liquid paintbrush data) ( 6) Termites applications to soil and sides of buildings near to ground, building perimeters, masonry voids,

and standing wood in uninhabited areas at residential,

commercial and industrial sites 0.05 lb ai/ gallon 5 gallons 2.6 6.8 17 Termites: preconstruction lumber and logs, soil under firewood 0.041 lb ai/ gallon 5 gallons 3.2 8.3 21 Non termite applications to indoor and outdoor surfaces at residential, commercial and industrial sites,

animal premises, and greenhouses; 0.017 lb ai/ gallon 5 gallons 7.8 20 51 Table 15: Cypermethrin Long Term Occupational Handler Summary Exposure Scenario Crop or Target Application Ratea ( lb ai/ unit) Amount Handled Dailyb Long Term Baseline Dermal +

Baseline Inhalation ARIc Long Term PPEGloves Dermal +

Baseline Inhalation ARId Long Term PPEGloves Dermal +

Dust/ Mist Respirator Inhalation ARIe 47 Mixing/ Loading/ Applying Wettable Powders with a Handheld Handgun ( ORETF) ( 7) agricultural uncultivated areas; fencerows, hedgerows;

ornamental plants; potting soil, topsoil 3.4 lb ai/ acre 5 acres no baseline dermal data 0.55 2.3 residential, commercial and industrial lawns 0.6 lb ai/ acre 5 acres no baseline dermal data 3.1 13 Mixing/ Loading/ Applying WSB Formulations with a Handheld Handgun ( ORETF) ( 8) agricultural uncultivated areas; fencerows, hedgerows;

ornamental plants; potting soil, topsoil 3.4 lb ai/ acre 5 acres no baseline dermal data 3.9 9.7 residential, commercial and industrial lawns 0.6 lb ai/ acre 5 acres no baseline dermal data 22 55 Footnotes a Application rates are the maximum application rates determined from EPA registered labels for Cypermethrin.

b Amount handled per day values are EPA estimates of acreage treated or gallons applied based on Exposure SAC Policy # 9 " Standard Values for Daily Acres Treated in Agriculture".

c Aggregate Risk Index = 1/{[ 1/( Baseline Dermal MOE/ Dermal UF 100)] + [ 1/( Baseline Inhalation MOE/ Inhalation UF 300)]} where an ARI greater than 1 is considered acceptable d Aggregate Risk Index = 1/{[ 1/( PPE gloves Dermal MOE/ Dermal UF 100)] + [ 1/( Baseline Inhalation MOE/ Inhalation UF 300)]} where an ARI greater than 1 is considered acceptable.

e Aggregate Risk Index = 1/{[ 1/( PPE gloves Dermal MOE/ Dermal UF 100)] + [ 1/( Dust/ Mist Respirator Inhalation MOE/ Inhalation UF  300)]} where an ARI greater than 1 is considered acceptable. 48 Table 16: Z cypermethrin Long Term Occupational Handler Summary Exposure Scenario Crop or Target Application Ratea Area Treated Dailyb Long term Baseline Dermal +

Baseline Inhalation ARIc Long term PPE Gloves Dermal +

Baseline Inhalation ARId Long term PPEGloves Dermal +

Dust/ Mist Respirator Inhalation ARIe Mixer/ Loader/ Applicator Mixing/ Loading/ Applying Liquid Concentrates with Low Pressure Handwand ( PHED) Indoor surfaces and Outdoor surfaces ( outdoor rate supplied by Registrant) 0.0044 lb ai/ gallon 40 gallons 0.095 110 470 Residential Lawns and Turfgrass at Commercial Sites ( Rate supplied by Registrant) 0.3 lb ai/ acre 5 acres 0.011 13 55 Outdoor surfaces ( rate from label) 0.001 lb ai/ gallon 40 gallons 0.42 500 2100 Mixing/ Loading/ Applying Liquid Concentrates with a Handgun Sprayer ( LCO ORETF data) residential lawns 0.3 lb ai/ acre 5 acres No Baseline Dermal Data 120 210 outdoor surfaces, surfaces of buildings, porches,

screens, window frames, eaves, patios, lawn area adjacent to or around private homes, duplexes,

townhouses, condominiums, house trailers apartment complexes, carports, garages, fence lines, storage sheds, barns, and other residential structures plus commercial, industrial, institutional buildings,

vegetation, refuse dumps, garages, and other outdoor surfaces 0.4356 lb ai/ acre 5 acres No Baseline Dermal Data 83 140 Mixing/ Loading/ Applying Liquid Concentrates with a Watering Can ( using ORETF residential hose end data) outdoor surfaces ( ant mounds) 0.006 lb ai/ mound 40 mounds 1.2 No PPE Dermal Data No PPE Dermal Data Table 16: Z cypermethrin Long Term Occupational Handler Summary Exposure Scenario Crop or Target Application Ratea Area Treated Dailyb Long term Baseline Dermal +

Baseline Inhalation ARIc Long term PPE Gloves Dermal +

Baseline Inhalation ARId Long term PPEGloves Dermal +

Dust/ Mist Respirator Inhalation ARIe 49 Mixing/ Loading/ Applying Liquid Concentrates with a Paint Brush outdoor surfaces ( general) ( rate from label) 0.001 lb ai/ gallon 5 gallons 1.9 340 860 Footnotes a Application rates are the maximum application rates determined from EPA registered labels for zeta cypermethrin.

b Amount handled per day values are HED estimates of acres, square feet, or cubic feet treated or gallons applied based on Exposure SAC SOP # 9 " Standard Values for Daily Acres Treated in Agriculture," industry sources, and HED estimates.

c Baseline inhalation: no respirator.

d PPE inhalation: assumes a dust/ mist removing quarter face style respirator providing an 80% protection factor e Eng Controls Inhalation: Closed mixing/ loading system, enclosed cab, or enclosed cockpit. 50 2.1.4 Summary of Risk Concerns and Data Gaps for Handlers Most occupational handler scenarios have risks associated with them that are below the Agency's level of concern at some level of risk mitigation. There are data gaps for evaluating exposures and risks for the following scenarios:

° applying cypermethrin or zeta cypermethrin using ready to use ear tags, and ° for applying zeta cypermethrin dust formulation using mechanical dusters.

No reasonable surrogate data are available to evaluate risks from these exposures.

2.1.5 Recommendations For Refining Occupational Handler Risk Assessment To refine this occupational risk assessment, data on actual use patterns including rates, timing, and area treated would better characterize cypermethrin and zeta cypermethrin risks. Exposure studies for many equipment types that lack data or that are not well represented in PHED ( e. g., because of low replicate numbers or data quality) should also be considered based on the data gaps identified above and based on a review of the quality of the data used in this assessment.

2.2. Occupational Postapplication Exposures and Risks EPA did not assess occupational postapplication risks to agricultural workers following treatments to agricultural crops, since no short or intermediate term dermal endpoints of concern were identified and long term exposures are not expected for tasks involving any of the registered crop use patterns. In lieu of a postapplication risk assessment, a restricted entry interval of 12 hours is assumed, unless the active ingredient and formulation meet all of the criteria listed in PR Notice 95 3 for low risk pesticides. Due to the lack of a developmental neurotoxicity study, cypermethrin and zeta cypermethrin do not meet the criteria in PR Notice 95 3 for low risk pesticides at this time.

EPA did not assess occupational postapplication exposures and risks following applications of cypermethrin and zeta cypermethrin to residential and commercial lawns, and in and around industrial, commercial, and residential premises, since no short or intermediate term dermal endpoints of concern were identified and long term exposures are not expected for tasks involving any of the registered use patterns.

2.3 Occupational Risk Characterization 2.3.1 Handler Characterization HED believes that the risk values presented in this occupational assessment represent the best quality results that could be produced given the exposure, use, and toxicology data that are available. HED also believes that the risks represent reasonable worse case estimates of exposure because maximum application rates are coupled with medium to high end estimates of area treated daily to define risk estimates that likely fall in the upper percentiles of the actual 51 exposure distributions.

3.0 Residential and Other Non Occupational Exposures and Risks There is a potential for exposure in residential settings during the application process for homeowners who use products containing cypermethrin. There are no products registered for homeowner use containing zeta cypermethrin as the active ingredient. There is a potential for exposure in residential settings from entering areas treated with cypermethrin and zetacypermethrin such as residential lawns, indoor surfaces and spaces, outdoor surfaces, and animal premises that could lead to nonoccupational exposures to adults and children. As a result, risk assessments have been completed for residential handler scenarios only for cypermethrin, and have been completed for postapplication scenarios for cypermethrin and zeta cypermethrin.

3.1 Residential Handler Exposures and Risks The Agency uses the term " handlers" to describe those individuals who are involved in the pesticide application process. The agency believes that there are distinct tasks related to applications and that exposures can vary depending on the specifics of each task as was described above for occupational handlers. Residential handlers are addressed somewhat differently by the Agency as homeowners are assumed to complete all elements of an application without the use of protective equipment.

3.1.1 Handler Exposure Scenarios The purpose of this section is to describe how the exposure scenarios are defined. Much of the process for residential uses is identical to that considered for the occupational assessment with a few notable exceptions that include:

° Residential handler exposure scenarios are only considered to be short term in nature due to the episodic uses associated with homeowner products;

° Homeowner handler assessments are completed based on individuals wearing shorts and short sleeved shirts;

° Homeowner handlers are expected to complete all tasks associated with the use of a pesticide product including mixing/ loading if needed as well as the application;

° Label use rates and use information specific to residential products serve as the basis for the risk calculations as opposed to the rates used in the occupational assessment; and ° Area/ volumes of spray or chemical used in the risk assessment are based on HED guidance specific to residential use patterns.

Exposure to pesticide handlers is likely during the residential use of cypermethrin in a variety of environments including on animals, animal premises, and treatments in and around homes. The anticipated use patterns and current labeling indicate several major residential exposure scenarios based on the types of equipment and techniques that can potentially be used to 52 make cypermethrin applications. The quantitative exposure/ risk assessment developed for residential handlers is based on these scenarios. [ Note: The scenario numbers correspond to the tables of risk calculations included in the occupational risk calculation aspects of the appendices.]

( 1) Liquid concentrates: mixing/ loading/ applying with low pressure handwand sprayer, ( 2) Liquid concentrates: mixing/ loading/ applying with wipe, ( 3) Liquid ready to use: applying with trigger pump sprayer, ( 4) Liquid ready to use: applying with aerosol can, ( 5) Liquid ready to use: indoor fogger, and ( 6) Liquid ready to use: applying with wipe.

3.1.2 Data and Assumptions For Handler Exposure Scenarios A series of assumptions and exposure factors served as the basis for completing the residential handler risk assessments. Each assumption and factor is detailed below. In addition to these factors, unit exposure values were used to calculate risk estimates. These unit exposure values were taken from the Pesticide Handlers Exposure Database ( PHED) or from Outdoor Residential Exposure Task Force ( ORETF) data.

The assumptions and factors used in the risk calculations include:

C Exposure factors used to calculate daily exposures to handlers were based on applicable data if available. For lack of appropriate data, values from a scenario deemed similar enough by the assessor might be used. In this assessment PHED mixer/ loader/ applicator data for aerosol can application is used to assess indoor fogger applications. The nature of these application methods are believed to be similar enough to bridge the data.

C The Agency always considers the maximum application rates allowed by labels in its risk assessments to consider what is legally possible based on the label.

C Residential risk assessments were not based on what could be applied in a typical workday like with the occupational risk assessments presented above. Instead, the HED based calculations on what would reasonably be treated by homeowners such as the size of a lawn, or the size of a garden. This information was used by the HED to define chemical use values for handlers which in turn were coupled with unit exposure values to calculate risks. The factors used for the cypermethrin assessment were those presented in the Health Effects Division Science Advisory Committee Policy 12: Recommended Revisions To The Standard Operating Procedures For Residential Exposure Assessment which was completed on February 22, 2001. The following daily volumes handled and area treated, excerpted from the policy and used in each residential scenario, include:

° 1 sixteen ounce ready to use aerosol can; ° 2 foggers; ° 1 one gallon pump trigger sprayer container; ° 5 gallons when mixing/ loading/ applying liquids outdoors with a low pressure handwand sprayer; and ° 1 animal when applying applications to pet horses. 53 Residential Handler Exposure Studies: The unit exposure values that were used in this assessment were based on studies included in the Pesticide Handler Exposure Database ( PHED, Version 1.1 August 1998), data provided by the Outdoor Residential Exposure Task Force, and data from the Chemical Manufacturers Association ( CMA) Antimicrobial Exposure Assessment Study. See the discussion in 2.1.2 for details.

3.1.3 Residential Handler Exposure and Risk Estimates The residential handler exposure and risk calculations are presented in this section. Risks were calculated using the Margin of Exposure ( MOE) as described in Section 2.1.3. Much of the process for residential uses is identical to that considered for the occupational assessment with a few notable exceptions as described above in Section 3.1.1 ( e. g., all are short term exposures and people wear shorts and short sleeved shirts with no gloves). The other major difference with residential risk assessments is that the uncertainty factor which defines the level of risk concern also has the additional FQPA safety factor applied. In the case of cypermethrin, the overall uncertainty factor applied to residential handler risk assessments is 1000, due to the lack of a developmental neurotoxicity study with a special protocol for pyrethroids.

Summary: The risk calculations for residential cypermethrin handlers are included in Appendix A ( Table A6) and summarized below.