Dihalodialkylhydantoin Occupational Residential Exposure Assessment Office of Pesticide Programs Antimicrobials Division U. S. Environmental Protection Agency 1801 South Bell St. Arlington, VA 22202 Page 2 of 45 AGRICULTURAL EXPOSURE/ RISK ASSESSMENT AND CHARACTERIZATION EXECUTIVE SUMMARY This document contains the occupational and residential exposure assessment for industrial, commercial, residential, and agricultural uses of a group of brominated compounds marketed as Dantobrom and Dantochlor. Bromochlorodimethylhydantoin, dichlorodimethylhydantoin, and dichloroethylmethylhydantoin are active ingredients used in Dantobrom and Dantochlor formulations used in the control of bacteria, fungi, and algal slimes. In addition, the hydroxymethylhydantoin, formulated as Dantogard, is used as a material preservative. ( For convenience, all formulations are hereafter referred to as ' dihalodialkylhydantoin'.)

Dihalodialkylhydantoin is an antimicrobial used to control slime formation in water systems and as a material preservative. Registered use sites for water systems include cooling water systems, paper and paperboard process water, wastewater treatment, use as an in tank toilet bowl sanitizer, and use in swimming pools. As a material preservative it is used to control bacteria and fungi in various other products such as detergents, fabric softeners, household cleaning products, paints, textiles, etc. Maximum application rates range from 0.000098 lb ai/ gallon for transportation cleaning water systems and up to 0.00122 lb ai/ gallon for spas. Dihalodialkylhydantoin is formulated in the following forms: tablet, pellet, briquette, granular, ready to use solution, wettable powder, soluble concentrate, liquid, and gel. The application rates used in the assessment are based on the maximum stated application rates on labels.

In lieu of toxicity data for dihalodialkylhydantoin, data for dimethylhydantoin, a principle component of dihalodialkylhydantoin, have been used. Acute toxicity categories for the technical grade dimethylhydantoin are toxicity category III for oral, category II for inhalation and category IV for dermal. The endpoints used in this document to assess dimethylhydantoin risks are the short and intermediate term dermal, inhalation, and ingestion. The short and intermediate term dermal and inhalation NOAELs are 390 mg/ kg/ day and 100 mg/ kg/ day, respectively. The dermal NOAEL is based on the highest level of exposure tested, as no systemic effects were noticed in the subchronic dermal toxicity study performed on rats. The inhalation NOAEL is based on skeletal effects observed in maternal rabbits oral study. An uncertainty factor or " target" margin of exposure ( MOE) of 100 is based on 10x for differences among humans ( intra species variability) and 10x for differences between the test animals and humans ( inter species extrapolation). Thus MOEs of greater than 100 do not exceed the Agency's level of concern for occupational uses. Exposures and MOEs for short and intermediate term aggregate exposure risk assessment for oral, dermal, and inhalation exposures cannot be combined due to the lack of a common endpoint of toxicity from the different routes of exposure.

5,5 dimethylhydantoin is classified as ` not likely' to be a carcinogen based upon the negative evidence for carcinogenicity in both the rat and mouse studies as well as the negative evidence of mutagenicity. Page 3 of 45 The scenarios considered in the risk assessment are shown in Table 1. These scenarios were selected based on examination of product labels describing uses for the product. Most of the scenarios fall under the " industrial premises and water systems" category. The material preservative use is assessed for general household cleaning products and paints.

Several different sources of handler exposure data were used to assess occupational and residential dihalodialkylhydantoin risks. Data from the both proprietary Chemical Manufacturers Association ( CMA) antimicrobial exposure study and the Pesticide Handlers Exposure Database ( PHED) were used.

Out of all scenarios considered, an MOE lower than the target MOE was found for only two scenarios: placing solids in a once through cooling water system ( Dermal MOE= 76), and greenhouse and nursery irrigation systems ( MOE = 14 for use of tablets with gloves, MOE = 2 for use of granules without gloves). Additional data are needed to refine the use information for these two scenarios.

There are a number of uncertainties associated with this assessment ( See Section 6.0). In general, conservative values were used in cases where data were lacking. Assessments for these scenarios should be considered as screening level. Page 4 of 45 Table 1. Dihalodialkylhydantoin Scenarios Use Site Category Scenario Industrial Premises and Water Systems ( Industrial) ° Placing the dihalodialkylhydantoin tablets/ pellets into cooling and process water systems ° Pouring dihalodialkylhydantoin granules/ powders into a feeder for cooling and process water systems ° Process water systems includes: recirculating cooling water, once through cooling water, sewage systems, pulp and paper process water, photo processing water, air washers, evaporative coolers, and cannery water Commercial, Institutional and Industrial Premises and Equipment ( Commercial/ Institutional Premises) ° Placing dihalodialkylhydantoin tablets into air conditioner/ humidifier drip pans ° Placing dihalodialkylhydantoin tablets in ornamental fountains ° Placing dihalodialkylhydantoin tablets in transportation cleaning water systems ° Commercial painters using paint preserved with dihalodialkylhydantoin Material Preservatives ° Pouring liquid dihalodialkylhydantoin into paints during manufacturing Swimming Pools ° Placing or pouring dihalodialkylhydantoin tablets/ granules in swimming pools and hot tubs Residential and Public Access Premises ( Residential) ° Handling of liquid general purpose cleaner ° Placing dihalodialkylhydantoin tablets into toilet tank ° Using brush/ roller/ airless sprayer to apply paint to house ° Toddler exposure to residues of carpet shampoo ° Toddler and adult exposure to treated clothing Agricultural Premises and Equipment ° Pouring dihalodialkylhydantoin granules vehicle and foot baths at the entrances to greenhouses Aquatic Areas ° Placing/ pouring dihalodialkylhydantoin tablets/ granules chemigation/ irrigation systems in greenhouses Page 5 of 45 1.0 BACKGROUND Purpose In this document, which is for use in EPA's development of the Dihalodialkylhydantoin Reregistration Eligibility Decision Document ( RED), EPA presents the results of its review of the potential human health effects of occupational and residential exposure to dihalodialkylhydantoin.

Criteria for Conducting Exposure Assessments An occupational exposure assessment is required for an active ingredient if ( 1) certain toxicological criteria are triggered and ( 2) there is potential exposure to handlers ( mixers, loaders, applicators, etc.) during use or to persons entering treated sites after application is complete. For dihalodialkylhydantoin, both criterion are met.

1.1 Summary of Toxicity Concerns Relating to Exposures Acute Toxicology Categories The hydantoins are a group of chemicals composed of several halogenated compounds ( i. e. a central organic hydantoin ring moiety ( either dimethylhydantoin or ethylmethylhydantoin) to which halogen atoms ( bromine and/ or chlorine) can be attached at both the 1 and 3 positions on the hydantoin ring), as well as hydroxymethylhydantoin compounds ( 1,3 bis( hydroxymethyl) 5,5 dimethylhydantoin and 1 hydroxymethyl) 5,5 dimethylhydantoin). These antimicrobial chemicals are used in the control of bacteria, fungi, and algal slimes in recirculating cooling water systems and sewage systems, industrial air washer systems, once through industrial cooling water systems, swimming pool water systems, ornamental ponds, fountains, and aquaria, toilet bowls and urinals, air filters/ air ducts, and various preserved products ( e. g., household cleaners).. The Office of Pesticide Programs has determined that the moieties of toxicological concern are 5,5 dimethylhydantoin ( DMH) and 5 ethyl 5 methyl hydantoin ( EMH), and recognized that it is most appropriate to test these organic moieties as representative of the toxicity of the hydantoins. Therefore, for the purposes of this assessment, the toxicity of dimethylhydantoin is considered as representative of the toxicity of the active ingredient.

Table 2 presents the acute toxicity categories as outlined in the toxicity memorandum dated August 28, 2000 ( USEPA, 2000a). A developmental neurotoxicity study was not required for dimethylhydantoins, since the evidence did not support the need for such a study. Page 6 of 45 Table 2. Acute Toxicity Categories for Dimethylhydantoin Study Type Toxicity Category Acute Oral Toxicity III Acute Dermal Toxicity IV Acute Inhalation Toxicity II Primary Eye Irritation I Primary Dermal Irritation II Dermal Sensitization Positive Sensitizer Acute Neurotoxicity No Study Available Other Endpoints of Concern Dimethylhydantoin  Report of the Hazard Identification Assessment Review Committee ( August 28, 2000) indicates that there are toxicological endpoints of concern for dimethylhydantoin. The endpoints and associated uncertainty factors used in assessing the risks for dihaloalkylhydantoin are presented in Table 3. Page 7 of 45 Table 3. Dimethylhydantoin Hazard Endpoints and Uncertainty Factors EXPOSURE SCENARIO DOSE ( mg/ kg/ day) ENDPOINT STUDY Acute Dietary ( females 13 50) NOAEL = 100 UF = 100 skeletal variations at 500 mg/ kg/ day developmental toxicity  rabbit Acute RfD = 1 mg/ kg Chronic Dietarya ( general population) NOAEL = 300 UF = 100 decreased body weight/ weight gain and lymph node hyperplasia chronic toxicity/ carcinogenicity ( rats)

Chronic RfD ( gen. Pop.) = 3 mg/ kg/ day Chronic Dietarya ( females 13 50) NOAEL = 100 UF = 100 Chronic RfD ( females 13 50) = 1 mg/ kg/ day developmental toxicity  rabbit Incidental Oral, Short Term NOAEL = 500 UF = 100 decreased body weight gain in maternal rabbits at 1000 mg/ kg/ day developmental toxicity  rabbit Incidental Oral, Intermediate Term NOAEL = 300 UF = 100 decreased body weight and liver weight at 1000 mg/ kg/ day subchronic oral toxicity  rats Dermal: Short , Intermediate, and Long Term NOAEL = 390 ( HDT) UF = 100 no systemic toxicity at the highest dose tested. subchronic dermal toxicity  rats Inhalation, Short Termb Oral NOAEL = 100 UF = 100 skeletal effects in offspring at 500 mg/ kg/ day developmental toxicity  rabbit aThe HIARC selected separate chronic RfDs for females 13 50 and the general population because this was an unusual case where the developmental NOAEL was lower than the lowest NOAEL available for chronic toxicity. The rabbit developmental toxicity study was therefore selected to provide adequate protection for the females 13 50 subpopulation. ba 100% inhalation absorption value is used for route to route extrapolation.

1.2 Summary of Use Pattern and Formulations Bromochlorodimethylhydantoin, dichlorodimethylhydantoin, and dichloroethylmethylhydantoin are active ingredients in Dantobrom and Dantochlor formulations used in the control of bacteria, fungi, and algal slimes. In addition, hydroxymethylhydantoin, formulated as Dantogard, is used as a material preservative ( For convenience, all Dantobrom/ Dantochlor/ Dantogard formulations are hereafter referred to as simply ' dihalodialkylhydantoin'.) At this time, products containing Page 8 of 45 dihalodialkylhydantoin are intended for occupational, agricultural, and residential/ commercial use. The occupational uses include: cooling water systems, paper and paperboard process water, wastewater treatment, and air washing systems. The residential/ commercial uses include: in tank toilet bowl sanitizer, antifoulant in swimming pools and ornamental fountains, and transportation cleaning water systems. Agricultural uses includes greenhouse chemigation systems and vehicle and foot baths at entrances to greenhouses. Material preservative uses include household cleaning products, paints, textiles, etc.

Formulation Types and Percent Active Ingredient Concentrations of dihalodialkylhydantoin in products range from 35% to 99%, with the vast majority containing concentrations above 90 percent. Most formulations are in solid form of tablets and pellets. However, dihalodialkylhydantoin is also available as briquettes, granules, powders, gels, and liquids for the material preservative use. Tables A1 to A7 in the appendix show how dihalodialkylhydantoin products are formulated.

1.3 Methods Used for Mixing/ Loading/ Applying The Agency determines potential exposures to handlers of the product by identifying exposure scenarios from the various application methods that are plausible, given the label uses. Based on reviewing product labels, the antimicrobial, residential, and agricultural use patterns specific to dihalodialkylhydantoin are associated with the following application equipment:

Industrial Uses:

° Placing the dihalodialkylhydantoin tablets/ pellets into cooling and process water systems, ° Pouring dihalodialkylhydantoin granules into a feeder for cooling and process water systems,

Material Preservative Uses:

° Liquid pouring dihalodialkylhydantoin into paints as representative of all material preservative uses.

Commercial Uses:

° Placing dihalodialkylhydantoin tablets into air conditioner/ humidifier drip pans ° Placing dihalodialkylhydantoin tablets in ornamental fountains ° Placing dihalodialkylhydantoin tablets in transportation cleaning water systems. ° Commercial painting ( brush/ airless sprayer).

Swimming Pool Uses: Page 9 of 45 ° Placing or pouring dihalodialkylhydantoin tablets/ granules in swimming pools and hot tubs,

Residential Uses:

° Placing dihalodialkylhydantoin tablets into toilet tanks, ° General household cleaning products ( mopping and wiping), ° Painting with brush/ airless sprayer ( material preservative use).

Agricultural Uses:

° Pouring dihalodialkylhydantoin granules in foot baths at the entrances to greenhouses.

Aquatic Area Uses:

° Placing/ pouring dihalodialkylhydantoin tablets/ granules in greenhouse chemigation/ irrigation systems,

2.0 INDUSTRIAL PROCESSES AND WATER SYSTEMS ( HANDLER AND POSTAPPLICATION)

Dihalodialkylhydantoin products are used in a variety of industrial applications, all of which relate to preventing slime formation in water systems. Concentrations of dihalodialkylhydantoin in these products range from 90% to 98%, are generally formulated as tablets, pellets, briquettes, or granules. The remaining formulations are either gels, wettable powders, or ready to use solutions, and all may be considered as solid ( as opposed to liquid) formulations.

2.1 Handler Exposures The handlers were identified as those individuals who use the formulated product in industrial/ commercial water systems to limit microbial growth. Systems in which the formulated product is used include recirculating cooling water, once through cooling water, pulp and paper process water, photo processing water, and transportation cleaning systems. The risks were assessed to the handlers using the dermal and inhalation exposure data for loading powder formulations from the proprietary Chemical Manufacturers Association ( CMA) antimicrobial exposure study ( DP Barcode D247642).

The following two primary handler exposure scenarios have been identified:

° Placing the dihalodialkylhydantoin tablets/ pellets into cooling and process water systems, and ° Pouring dihalodialkylhydantoin granules/ powders into a feeder for cooling and process water systems. Page 10 of 45 Daily Inhal Exposure mg AI day Inhal Unit Exposure mg AI lb AI Max Appl Rate lb AI Gal Max Volume Treated Gallons Day . . .. .

     =

     Daily Inhalation Exposure mg day inhalation absorption inhalation tox study Body Weight kg ( / ) ( )

( )      1 Short and Intermediate Duration Exposure MOE NOAEL mg kg day Daily Dose mg kg day = ( / / )

( / / ) These two types of exposure scenarios were assessed for each of the water systems in question. The methods for applying gels, briquettes, and ready to use solutions are nearly identical to at least one of the two methods described above, based on the directions on the label. Therefore, although the two exposure scenarios considered include only products that are tablets, pellets, granules, or wettable powders, these scenarios should be sufficient to describe the risks associated with all formulations.

The exposure/ risks were calculated using the following equations. Potential daily inhalation exposure is calculated using the following formula:

The daily dermal exposures were calculated using the following formula:

These calculations of potential daily exposure to dihalodialkylhydantoin by handlers are used to calculate the potential doses and total risk to those handlers.

Daily Short and intermediate term Dermal Dose ( mg/ kg/ day) is calculated as:

Daily Dermal Exposure mg day dermal absorption dermal tox study Body Weight kg ( / ) ( )

( )      1 Daily Short and Intermediate term Inhalation Dose ( mg/ kg/ day) is calculated as:

Margin of Exposure ( MOE) is calculated by dividing the NOAEL by the daily dose. Page 11 of 45 The following assumptions were used in calculating the exposures/ risks:

Application rates  The rate at which dihalodialkylhydantoin is applied varies for each type of water system. Table 4 shows the maximum label recommended rates for the various systems. In general, different labels for the same use have the same application rates. However, some labels differ slightly, and only the highest listed concentration for each water system is shown in the table. Table 4 shows both the initial dose needed when the system is noticeably fouled, and the subsequent doses needed to maintain control. Rates in Table 4 are given in terms of weight of formulated product. In order to determine rates in terms of active ingredient, the values must be multiplied by the percent of the active ingredient in the formulation. Most formulations are above 95% active ingredient, with the exception of the gel based products, which have concentrations between 35% and 40%.

Amount handled  Most of the estimates for the amount of water or paper that is handled by each worker have been taken from the report Antimicrobial Pesticides, Uses, Human Exposures, and Risk Assessments that contains use information for selected scenarios related to antimicrobials ( Dang, 1996). The estimates used are shown in Table 5. Data were available for cooling water systems and were used to calculate exposures to recirculating cooling water systems and oncethrough water cooling systems. In the absence of better information, an estimate of 20,000 gallons/ day was used for wastewater treatment, photo processing process water, air washers, evaporative cooler, and cannery water scenarios. Page 12 of 45 Table 4. Maximum Recommended Doses for Industrial Water Systems Water System Maximum Application Rate of Formulated Product ( Initial) a Maximum Application Rate of Formulated Product ( Subsequent) a Percent Active Ingredientb Recirculating Cooling Water 1.0 lbs/ 1000 gallons 0.75 lbs/ 1000 gallons 98 Once Through Cooling Water 1.0 lbs/ 1000 gallons 0.30 lbs/ 1000 gallons 98 Wastewater Treatment 1.0 lbs/ 1000 gallons 0.75 lbs/ 1000 gallons 98 Pulp and Paper Process Water 2 lbs/ 100 tons paper 2 lbs/ 100 tons paper 98 Photo Processing Water 9 g/ 1000 gallons 9 g/ 1000 gallons 98 Air Washer 1.0 lbs/ 1000 gallons 0.75 lbs/ 1000 gallons 98 Evaporative Cooler 0.6 lbs/ 1000 gallons 0.3 lbs/ 1000 gallons 96 Cannery Water 288 mg/ L 216 mg/ L 40 aUnits are given in terms of weight of formulated product, not weight of active ingredient. bThe percentage is the percent active ingredient from the label with the maximum rate of application of active ingredient.

Table 5. Use Information Water System Use Rate Recirculating Cooling Water 8,000 gal water/ day Once Through Cooling Water 100,000 gal water/ day Wastewater Treatment 20,000 gal water/ day Pulp and Paper Process Water 100 tons paper/ day Photo Processing Water 20,000 gal water/ day Air Washer 20,000 gal water/ day Evaporative Cooler 20,000 gal water/ day Cannery Water 20,000 gal water/ day Values for unit exposures come from two sources: the CMA study ( USEPA, 1999) and Dang, 1996.

° Solid Pour  The CMA data for pouring solid formulations for preservatives are based on transferring powder/ flakes from large containers to smaller containers for measuring and pouring. Visible dusts were generated during certain phases of application. Some applicators wore aprons. Page 13 of 45 Ten of 11 test subjects wore protective gloves. These products were applied from 2 to 285 minutes per application.

° Solid Place  The CMA data for placing solid formulations are based on placing water soluble packets, tablets, and permeable " tea" bags onto machines. The time required to apply these packets to 40 machines took between 12 to 20 minutes. In the study, 2 or 3 replicates wore gloves.

° Pulp and Paper  Unit exposures for pulp and paper are taken from Dang, 1996. The value for placing solid formulations in pulp and paper process water is based on five 1 lb test packages that were placed in 3 gallons of water.

The results of the MOE analysis are presented in Table 6. For industrial use, the short and intermediate term dermal and inhalation MOEs for the primary handlers wearing long pants, long sleeved shirts, chemical resistant gloves, goggles, and a face shield ( as required by the label) were determined. Dermal MOEs range from a high of 151,000 for solid pour in photo processing water systems, to 76 for solid place in once through cooling water systems. Except for once through cooling water systems, all MOEs are above the EPA required margin of exposure ( 100). Page 14 of 45 Table 6. Short and Intermediate term Risks Associated with Industrial Uses of Dihalodialkylhydantoin Exposure Scenario Method of Application Clothing Attire Dermal Unit Exposure ( mg/ lb ai) a Inhalation Unit Exposure ( mg/ lb ai) b Appl.

Rate c ( lb a. i./ gal) Amount Treated d Dermal Dose ( mg/ kg/ day) e Dermal MOE f Inhalation Dose ( mg/ kg/ day) g Inhalation MOE f Recirculating Cooling Water Solid Place Long pants,

long sleeved shirt,

chemical resistant gloves, goggles,

and face mask 11.9 0.257 0.00075 8000 gal 1.0 390 0.0216 4630 Solid Pour 0.466 0.0151 0.00075 8000 gal 0.0391 9960 0.00127 78800 Once Through Cooling Water Solid Place 11.9 0.257 0.0003 100000 gal 5.1 76 0.11 909 Solid Pour 0.466 0.0151 0.0003 100000 gal 0.20 1950 0.0065 15385 Wastewater Treatment Solid Place 11.9 0.257 0.000735 20000 gal 2.5 156 0.054 1850 Solid Pour 0.466 0.0151 0.000735 20000 gal 0.0979 3990 0.00317 31500 Pulp and Paper Process Water Solid Place 11.9 0.257 1.96 lb /

100 tons paper 100 tons paper 0.333 2730 0.00720 32,400 Solid Pour 0.466 0.0151 1.96 lb /

100 tons paper 100 tons paper 0.0130 69,700 0.000423 552,000 Photo Processing Water Solid Place 11.9 0.257 1.94x10 5 20000 gal 0.0661 5900 0.00143 70100 Solid Pour 0.466 0.0151 1.94x10 5 20000 gal 0.00259 151000 0.0000838 1190000 Air Washer Solid Place 11.9 0.257 0.000735 20000 gal 2.5 156 0.054 1850 Solid Pour 0.466 0.0151 0.000735 20000 gal 0.0979 3990 0.00317 31500 Evaporative Cooler Solid Place 11.9 0.257 0.00072 20000 gal 2.45 159 0.0529 1890 Solid Pour 0.466 0.0151 0.00072 20000 gal 0.0959 4070 0.00311 32200 Cannery Water Solid Place 11.9 0.257 0.00072 20000 gal 2.45 159 0.0529 1890 Solid Pour 0.466 0.0151 0.00072 20000 gal 0.0959 4070 0.00311 32200 a, b Dermal and inhalation unit exposures are from CMA study. Solid pour unit exposures are based on values for cooling towers, while solid place values are based on preservatives.

c Application rates are based on the dihalodialkylhydantoin labels.

d Amount treated is based on Dang, 1996.

e Abs. dermal dose ( mg/ kg/ day) = [ unit exposure ( mg/ lb ai) * dermal absorption ( 1.0) * Appl. rate ( lb ai/ gallon) * gallons handled / Body weight ( 70 kg).

f MOE = NOAEL ( mg/ kg/ day) / Daily Dose [ Where short and intermediate term dermal and inhalation NOAEL = 390 mg/ kg/ day and 100 mg/ kg/ day, respectively]. Target MOE is 100.

g Inhalation dose ( mg/ kg/ day) = [ unit exposure ( mg/ lb ai)* max appl rate * amount treated * 1 inhalation absorption] / Body weight ( 70 kg). Page 15 of 45 2.2 Postapplication Exposures Postapplication inhalation exposures may occur in the industrial settings around the water systems via inhalation, and dermal exposures may occur while maintaining industrial equipment. However, occupational postapplication dermal and inhalation exposures to dihalodialkylhydantoin are likely to be minimal compared to handler exposure because of dilution during processing. No postapplication exposure data have been submitted to the agency to determine the extent of postapplication exposures in the industrial settings. Inhalation exposures are expected to be minimal because aerosol generation is not expected and the vapor pressure of dihalodialkylhydantoin is low ( the vapor pressure of a principal component, Bromochloro 5,5 dimethylhydantoin, is 7.01x10 5 mm Hg ( Clearon, 2003).

3.0 MATERIAL PRESERVATIVE, COMMERCIAL/ INSTITUTIONAL PREMISES AND SWIMMING POOLS ( HANDLER AND POSTAPPLICATION)

3.1 Occupational and Residential Handlers 3.1.1 Handler Exposures Scenarios Commercial use of dihalodialkylhydantoin is similar in purpose to industrial useBit is used to prevent slime formation in water systems. In addition, it is used as a material preservative in paints, etc. Six scenarios have been identified to represent the high end exposure potential for these uses:

° Liquid pour of product into paint during manufacturing as a material preservative, ° Solid place of product in air conditioner / humidifier drip pans, ° Solid place of product in ornamental fountains, ° Solid place of product for use in transportation cleaning water systems, ° Commercial painters ( brush/ airless sprayer); ° Solid place/ pour of product in commercial swimming pools and spas; and ° Metal working fluids ( machinist).

The material preservative use assessed for paints is believed to be representative of the other preservative uses on the labels such as detergents, fabric softeners, household cleaning products, surfactants, polymer emulsions, coatings, textiles, adhesives, sealants and caulks, and inks. Therefore, separate commercial general cleaning scenarios ( i. e., mopping and wiping) have not been assessed. Occupational exposure occurs when pouring or pumping using metering systems. Exposure occurs either via loading and filling of bulk tanks, contact with pipes, or hoses or setup/ maintenance of the automated metering system. General preservatives are added to a mechanical system and mixed into slurries in tanks or bins.

There also exist ready to use solutions available for use in air conditioner/ humidifier drip pans, ornamental fountains, and swimming pools/ spas. However, based on the directions given in the labels for these products, application is similar to the placement of tablets. Therefore ready to use solutions are assumed to be applied via solid placement of the product.

The use of dihalodialkylhydantoin in residential scenarios is also possible for air conditioner drip pans and swimming pools. In residential scenarios, handlers are traditionally assessed using baseline Page 16 of 45 conditions only. However, commercial handlers are assessed using both baseline and PPE ( e. g., with gloves). The assumption for residential handlers is that label requirements for PPE for homeowners are not enforceable, so a worst case baseline assumption is used to assess these handlers. The application rates used for both types of scenarios have been assumed to be the typical rates for commercial applications. This will be an overestimate of the typical use rates for residential handlers.

Exposure/ risks were calculated using the same equations as for industrial use scenarios. The following assumptions were made in calculating the exposures/ risks:

° Application rates  The rate at which dihalodialkylhydantoin is applied varies for each use. Table 7 shows the maximum label recommended rates for the various systems. In general, different labels for the same use have the same application rates. However, some labels differ slightly, and only the highest listed concentration for each water system is shown in the table. Table 7 shows both the initial dose needed when the system is noticeably fouled, and the subsequent doses needed to maintain control. For air conditioner/ humidifier drip pans, the labels state that " one or more tablets" should be used as needed. The weight of the tablet is 20 grams. For lack of specific label information, it was assumed that three tablets is a worst case estimate of the amount of tablets needed to disinfect air conditioner/ humidifier drip pans. Rates in Table 7 are given in terms of weight of formulated product. In order to determine rates in terms of active ingredient, the values must be multiplied by the percent of the active ingredient in the formulation.

Table 7. Maximum Recommended Doses for Commercial Uses Use Maximum Application Rate of Formulated Product ( Initial) a Maximum Application Rate of Formulated Product ( Subsequent) a Percent Active Ingredientb Commercial/ Institutional Premises Material Preservative 2 percent by weight of formulated product 52.4 Air Conditioner / Humidifier Drip Pans 3 tablets 3 tablets 98 Ornamental Fountains 6 lbs/ 10,000 gallons 3 lbs/ 10,000 gallons 98 Transportation Cleaning 0.2 lbs/ 1000 gallons 0.10 lbs/ 1000 gallons 98 Commercial Painters 2 percent by weight of formulated product 52.4 Swimming Pools / Spas Swimming Pools 180 g/ 10,000 gallons 180 g/ 10,000 gal 98 Spas 85 g/ 150 gallons 85 g/ 150 gallons 98 aThe rates listed are the maximum rate of application of formulated product, not the maximum rate of application of active ingredient. bThe percentage is the percent active ingredient from the label with the maximum rate of application of active ingredient. Page 17 of 45 $ Amount handled  Estimates for the amount of water that is treated by each worker are shown in Table 8. Very little data could be found regarding typical amounts handled by workers. These values are mostly estimates based on searching for typical values used for each type of equipment. For a worker performing air conditioning maintenance in a large institution, it has been assumed that 3 air conditioner units were maintained. Commercial painters are assumed to handle 5 gallons/ day with a brush/ roller and up to 50 gallons/ day for an airless sprayer. A large ornamental pond was assumed to be the same size as an average residential swimming pool ( the value for average swimming pool size is from Dang, 1996). For an in bay car wash, the average water consumption is 45.7 gallons per vehicle, based on a study by the International Carwash Association ( Brown, 2002). Based on anecdotal evidence, it has been assumed that an in bay car wash services 220 vehicles per day ( Clements, 2003). The EPA also calculated the exposures for workers at a public swimming pool, using the assumption that a public swimming pool is 200,000 gallons. A residential pool is assumed to be 20,000 gallons. A large commercial spa contains about 1000 gallons of water. Tablets in air conditioner drip pans are added once every 6 months, as noted in a label. In the remaining scenarios, workers perform their duties daily during the standard 5 day work week. These values are conservative estimates and used simply for lack of better data.

Table 8. Use Information for Commercial Applications Use Use Rate Commercial/ Institutional Premises Material Preservative 10,000 lbs paint ( 1,000 gallon paint batch)

Air Conditioner / Humidifier Drip Pans 3 air conditioner units Ornamental Fountains 17,000 gallons Transportation Cleaning 9800 gallons / day Commercial Painters 5 gallons/ day brush and 50 gal/ day airless Swimming Pools / Spas Swimming Pools ( Residential) 20,000 gallons Swimming Pools ( Public/ Commercial) 200,000 gallons Spas 1000 gallons The results of the MOE analysis for both baseline ( ungloved) and PPE ( gloved) scenarios are presented in Table 9a and 9b, respectively. For commercial uses, the short and intermediate term dermal MOEs for the handlers wearing PPE range from 140 to 151,000. An MOE lower than the target MOE was found for only one scenarioBplacing tablets into public swimming pools wearing baseline protection ( MOE= 46). However, the product labels state that gloves should be worn when placing tablets into swimming pools. When gloves are used ( see Table 9b) the risks are mitigated for the placing of tablets ( MOE = 7,500). Page 18 of 45 Table 9a. Short and Intermediate term Risks Associated with Commercial, Institutional, and Swimming Pool Uses of Dihalodialkylhydantoin ( Baseline Clothing Scenario) a Exposure Scenario Method of Application Dermal Unit Exposure ( mg/ lb ai) b Inhalation Unit Exposure ( mg/ lb ai) c Appl. Rate d ( lb a. i./ gal) Amount Treated e Dermal Dose ( mg/ kg/ day) f Dermal MOE g Inhalation Dose ( mg/ kg/ day) h Inhalation MOE i Material Preservative and Commercial/ Institutional Premises Material Preservative Pour Liquid 0.135 0.0036 0.1048 1,000 gal 0.20 1,900 0.0054 19,000 Air Conditioner /

Humidifier Drip Pans Solid Place 10.8 0.00138 0.98 lb/ AC Unit 3 AC Units 0.454 860 0.000058 1,730,000 Ornamental Fountains Solid Place 10.8 0.00138 0.000294 17000 gal 0.771 506 0.0000985 1,010,000 Transportation Cleaning Solid Place 10.8 0.00138 0.000098 9800 gal 0.148 2630 0.0000189 5,280,000 Commercial Painters Brush/ roller 180 0.28 0.1048 5 gal 1.3 290 0.0021 48,000 Airless Sprayer 38 0.83 0.1048 50 gal 2.8 140 0.062 1,600 Swimming Pools / Spas Swimming Pools ( Residential,

Shortterm only) Solid Place 10.8 0.00138 3.89x10 5 20,000 gal 0.12 3200 1.5E 5 6,500,000 Solid Pour 76.2 0.0412 3.89x10 5 20,000 gal 0.85 460 0.00046 220,000 Swimming Pools ( Public/ Commercial) Solid Place 10.8 0.00138 3.89x10 5 200,000 gal 1.2 325 0.000153 653,000 Solid Pour 76.2 0.0412 3.89x10 5 200,000 gal 8.46 46.1 0.00457 21,900 Spas Solid Place 10.8 0.00138 0.00122 1000 gal 0.396 984 0.0000506 1,970,000 Solid Pour 76.2 0.0412 0.00122 1000 gal 2.8 139 0.00151 66,500 a In baseline scenarios, it is assumed that handler is wearing long pants, and long sleeved shirt.

b Dermal unit exposures are from CMA study.

c Inhalation unit exposures are from CMA study.

d Application rates are based on the dihalodialkylhydantoin labels.

e See Table 8 for more information regarding use rates.

f Dermal dose ( mg/ kg/ day) = [ unit exposure ( mg/ lb ai) * Appl. rate ( lb ai/ gallon) * gallons handled / Body weight ( 70 kg).

g MOE = NOAEL ( mg/ kg/ day) / Daily Dose [ Where short and intermediate term dermal NOAEL = 390 mg/ kg/ day]. Target MOE is 100.

h Inhalation dose ( mg/ kg/ day) = [ unit exposure (

g/ lb ai) * 0.001 mg/

g unit conversion * max appl rate ( lb ai/ gal) * gallons handled * 1 inhalation absorption] / Body weight ( 70 kg).

i MOE = NOAEL ( mg/ kg/ day) / Daily Dose [ Where short and intermediate term inhalation NOAEL = 100 mg/ kg/ day]. Target MOE is 100. Page 19 of 45 Table 9b. Short and Intermediate term Risks Associated with Commercial, Institutional, and Swimming Pool Uses of Dihalodialkylhydantoin ( with gloves only) a Exposure Scenario Method of Application Dermal Unit Exposure ( mg/ lb ai) b Inhalation Unit Exposure ( mg/ lb ai) c Appl. Rate d ( lb a. i./ gal) Amount Treated e Dermal Dose ( mg/ kg/ day) f Dermal MOE g Inhalation Dose ( mg/ kg/ day) h Inhalation MOE i Commercial/ Institutional Premises Air Conditioner /

Humidifier Drip Pans Solid Place 0.412 0.00138 0.98 lb/ AC Unit 3 AC Units 0.017 22,940 0.000058 1,730,000 Ornamental Fountains Solid Place 0.412 0.00138 0.000294 17000 gal 0.029 13,450 0.0000985 1,010,000 Transportation Cleaning Solid Place 0.412 0.00138 0.000098 9800 gal 0.0057 68,420 0.0000189 5,280,000 Swimming Pools / Spas Swimming Pools ( Public/ Commercial) Solid Place 0.412 0.00138 3.89x10 5 200,000 gal 0.046 8,480 0.000153 653,000 Solid Pour 0.466 0.0412 3.89x10 5 200,000 gal 0.0517 7,538 0.00457 21,900 Spas Solid Place 0.412 0.00138 0.00122 1000 gal 0.0072 5,420 0.0000506 1,970,000 Solid Pour 0.466 0.0412 0.00122 1000 gal 0.00814 47,900 0.00151 66,500 a In PPE scenarios, it is assumed that handler is wearing long pants, long sleeved shirt, chemical resistant gloves, and respirator.

b Dermal unit exposures are from CMA study.

c Inhalation unit exposures are from CMA study.

d Application rates are based on the dihalodialkylhydantoin labels.

e See Table 8 for more information regarding use rates.

f Dermal dose ( mg/ kg/ day) = [ unit exposure ( mg/ lb ai) * Appl. rate ( lb ai/ gallon) * gallons handled / Body weight ( 70 kg).

g MOE = NOAEL ( mg/ kg/ day) / Daily Dose [ Where short and intermediate term dermal NOAEL = 390 mg/ kg/ day]. Target MOE is 100.

h Inhalation dose ( mg/ kg/ day) = [ unit exposure ( mg/ lb ai) * max appl rate ( lb ai/ gal) * gallons handled * 1 inhalation absorption] / Body weight ( 70 kg).

i MOE = NOAEL ( mg/ kg/ day) / Daily Dose [ Where short and intermediate term inhalation NOAEL = 100 mg/ kg/ day]. Target MOE is 100. Page 20 of 45 Metal Working Fluids: The potential inhalation and dermal exposure may exist when using treated metal working fluid. A screening level long term inhalation exposure estimate for treated metal working fluids has been developed using the OSHA PEL for oil mist. The Agency conducted the screening level assessment for metal working fluids using the Chemical Engineering Branch ( CEB) model ( U. S. EPA, 1991). Exposure assumptions used in the model are presented in Dang, 1997. The CEB model uses measured and/ or assumed airborne oil mist concentrations for metal working operations. Since no measured concentrations are available for hydantooins, the high end oil mist concentration is based on the OSHA's Permissible Exposure Limit ( PEL) of 5 mg/ m3 ( NIOSH, 1998). The label indicates that 0.45% ( i. e., 0.0045) of the product is added to metal working fluids and of that, only 52.4% is the active ingredient. Therefore, the upper bound air concentration of hydantoin that a worker is exposed to is 5 mg/ m3 x 0.0045 x 0.524 or an air concentration of 0.012 mg/ m3. Additionally, the following assumption were made in the assessment: the inhalation rate for adults is 1.25 m3 / hr; the exposure duration is 8 hours; and body weight is 70 kg. Using these assumptions, the long term dose was calculated to be 0.0017 mg/ kg/ day, resulting in a long term MOE of 59,000. Therefore, the calculated MOE indicates that the inhalation risks do not exceed the Agency's level of concern for machinist exposures to metal working fluid.

A screening level long term dermal exposure estimate was derived from the 2 Hand Dermal Immersion in Liquid Model in ChemSTEER ( EPA/ OPPT). The model is available at www. epa. gov/ opptintr/ exposure/ docs/ chemsteer. htm . The weight fraction of hydantoin in metal working fluids is 0.0024 ( 0.0045 formulated product added to oil x 0.524 ai in formulated product = 0.0024). Based on the model for emersion of hands in metal working fluids, the long term dermal dose is estimated at 0.3 mg/ kg/ day. The long term dermal MOE is 1,300 ( i. e., dermal NOAEL of 390 mg/ kg/ day / potential dose of 0.3 mg/ kg/ day). The dermal MOE is above the target MOE of 100, and therefore, the risk is not of concern. 3.2 Postapplication Exposure There are postapplication exposures to dihalodialkylhydantoin associated with use of swimming pools and spas. Because the amount of exposure will most likely be much greater for swimming pools than for spas, only swimming pool scenarios have been considered.

To calculate exposure to the chemical due to swimming, the SWIMODEL was employed ( Dang, 1996). The model requires information regarding the water concentration, the nature of the chemical in question, and exposure information. The water concentration in pool water is based on information from the labels. The body surface area is 22,200 cm2 for adults and 9,000 cm2 for children ( age 6 years) ( EPA, 1997). Exposure time and exposure frequency are based on SWIMODEL. An octanol partition coefficient of 0.22, a molecular weight of 197 g/ mol, and a Henry's Law Constant of 1.27x10 7 atm m3/ mol were used in the model. Other parameters used in the model are shown in Table 10. Table 11 shows dermal, inhalation, and ingestion MOE values based on the results of the SWIMODEL. MOE values for all scenarios are much greater than the required 100. Page 21 of 45 Table 10. Parameters for Ingestion Exposure and Dose Estimate for Males Age Adult Adult Child 7 10 yr Child 7 10 yr Type of Swimmer Competitive Non Competitive Competitive Non competitive Water Concentration ( ppb) 3000 3000 3000 3000 Exposure Time ( hrs/ event) 3 1 1 2 Body Weight ( kg) 70 70 29.1 29.1 Dermal Dose ( mg/ event) 0.00816 ( 0.00012 mkd) 0.00272 ( 0.000039 mkd) 0.00151 ( 0.000052 mkd) 3.02x10 3 ( 0.0001 mkd)

Inhalation Dose ( mg/ event) 0.15 1.56x10 2 0.0297 3.12x10 2 Ingestion Dose ( mg/ event) 0.45 0.075 0.15 0.30 Table 11. Margins of Exposure for Swimming Poola Age Type of Swimmer Dermal MOE Inhalation MOE Ingestion MOE Adult Competitive 2,500,000 52,100 47,000 Adult Non competitive 7,700,000 501,000 280,000 Child 7 10 yr Competitive 5,800,000 98,000 58,000 Child 7 10 yr Non competitive 3,000,000 93,300 29,000 aMOE = NOAEL ( mg/ kg/ day)/ Dose( mg/ kg/ day). Dermal route is based on an absorbed dose, and therefore, the oral endpoint is used to estimate risk. The inhalation and ingestion NOAELs are 100 mg/ kg/ day and 300 mg/ kg/ day ( intermediate term), respectively. Target MOE = 100.

4.0 RESIDENTIAL AND PUBLIC ACCESS PREMISES ( HANDLER AND POSTAPPLICATION)

4.1 Residential Handlers Dihalodialkylhydantoin may be added to residential use products as a material preservative to control bacteria and fungicide. A number of such products have been identified, including general household cleaning products, paint, adhesives, and deodorizers. For the purposes of this screening level assessment, handler scenarios have been developed that encompass multiple products but still Page 22 of 45 represent the high end exposure scenario for all products represented. Table 12 shows the handler scenarios considered in this assessment. Household cleaning products and carpet shampoo have been grouped together. Of these products, household cleaning products, which should yield the greatest amount of handler exposure to the chemical, was selected for analysis. In tank toilet tablets, which are placed into toilet tanks, differ from the other household cleaning products in that they are not liquid. These tablets were evaluated in a separate scenario. Adhesives, caulks, and paints have been grouped together for evaluation. Of the these three scenarios, the painting scenario, which should yield the greatest amount of handler exposure to the chemical, was selected for analysis. [ Note: The residential handlers for swimming pool applications are presented in Section 3.0 ( results are presented in Table 9a)].

Table 12. Residential Handler Scenarios Handler Scenario Products Represented Handling of liquid general purpose cleaner Household cleaning products ( e. g., wiping and mopping), carpet shampoo, deodorizer Solid placement of in tank toilet cleaner In tank toilet tablet Painting of a house using brush, roller, or airless sprayer Paint, adhesives, caulk 4.1.1 General Purpose Cleaner Scenario EPA has estimated dermal and inhalation exposure while wiping and mopping to represent the material preservative use for household cleaning products. The following two scenarios were considered for residential handlers of household cleaning products preserved with dihalodialkylhydantoins:

° Use of household cleaning products by wiping on hard non porous surfaces, and ° Use of household cleaning products by mopping on floors.

An application rate could not be determined from the labels. Therefore, the maximum concentration listed on the label ( i. e., EPA Reg. No. 6836 271) is used along with assumptions on the amount of cleaning product diluted in water. EPA Reg. No. 6836 271 indicates that the product, Dantogard Plus Liquid, can be added to household cleaning products at a rate of 0.2 to 2.0 percent by weight. Given that EPA Reg. No. 6836 271 contains 52.4 percent active ingredient associated with this RED case ( i. e., 26.9% 1,3 Bis( hydroxymethyl) 5,5 dimethylhydantoin plus 25.5% 1( Hydroxymethyl) 5,5 dimethylhydantoin) and an assumption that the product has the density of water, yields an estimate of 0.084 lb ai/ gallon of a generic household cleaning product ( i. e., 8 lb/ gal cleaner x 0.02 Dantogard x 0.524 ai). Additionally, it is assumed that 4 ounces of a generic household cleaning product is mixed per gallon of water or 0.0026 lb ai/ gallon of diluted cleaning solution for both mopping and wiping ( i. e., 0.084 lb ai/ gal cleaning product x ( 1/ 128 ounce per gallon conversion) x 4 ounces cleaning product per gallon water).

CMA data were used to determine the unit dermal and inhalation exposures. The no gloved CMA unit Page 23 of 45 exposure data for wiping and mopping were used to determine the dermal and inhalation exposure. It was assumed that 0.5 liter ( 0.132 gallons) is used for wiping and 1 gallon is used for mopping. The 0.5 liter assumption for the wipes is a screening level estimate and should be refined by the registrant.

The results of the MOE analysis for these scenarios are presented in Table 13. Although the dermal endpoint represents short, intermediate, and long term durations, the exposure duration of most homeowner applications of cleaning products is believed to be best represented by the short term duration. The inhalation endpoint used in the assessment represents the short term duration. The calculated dermal and inhalation MOEs are not of concern for any of the scenarios ( MOE greater than 10,000 for all scenarios). However, as formaldehyde is a metabolite of dihalodialkylhydantoins, there may be risk associated with this exposure, particularly for use of products that produce a greater chance of inhalation exposure to formaldehyde, such as air fresheners. Risks associated with formaldehyde will be assessed at a later date.

Table 13. Calculation of Short term Dermal and Inhalation MOE for Residential Handlers of Cleaning Products a Exposure Scenario Method of Applicatio n Dermal Unit Exposure ( mg/ lb ai) b Inhalation Unit Exposure ( mg/ lb ai) c Appl. Rate d ( lb a. i./ gal) Amount Treated Dermal Dose ( mg/ kg/ day) f Dermal MOE g Inhalation Dose ( mg/ kg/ day) h Inhalatio n MOE i Household Cleaning Products Wipes 2870 ( CMA no glove) 67.3 ( CMA) 0.0026 0.5 liter of product ( 0.13 gal) 0.014 28,000 0.00033 300,000 Mopping 71.6 2.38 0.0026 1 gallon 0.0053 73,000 0.00018 570,000 a MOEs rounded to 2 significant figures. b Dermal unit exposures are from CMA. c Inhalation unit exposures are from CMA. d Application rates are based on EPA Reg. No. 6836 271. f Dermal dose ( mg/ kg/ day) = [ unit exposure ( mg/ lb ai) * Appl. rate ( lb ai/ gallon) * gallons handled / Body weight ( 70 kg). g Dermal MOE = NOAEL ( mg/ kg/ day) / Daily Dose [ Where short term dermal NOAEL = 390 mg/ kg/ day]. Target MOE is 100. h Inhalation dose ( mg/ kg/ day) = [ unit exposure ( mg/ lb ai) * max appl rate ( lb ai/ gal) * gallons handled * 1 inhalation absorption] / Body weight ( 70 kg). i Inhalation MOE = NOAEL ( mg/ kg/ day) / Daily Dose [ where short term inhalation NOAEL is 100 mg/ kg/ day]. Target MOE is 100. Page 24 of 45 4.1.2 In Tank Toilet Cleaner Scenario All products available for use of dihalodialkylhydantoin as a toilet cleaner are in tablet form. Calculation of the MOE for this scenario is shown in Table 14. Based on the size of available retail toilet tank tablets, the weight of a toilet tank tablet was estimated at 0.08 lb/ tablet ( e. g., 12 tablets per 1 lb box). It has also been assumed that the person maintains a house containing three toilets. The clothing attire is assumed to be short pants and short sleeved shirt. The unit exposure values, which are the same as those used for previous solid place scenarios, are taken from CMA data. However, the ungloved scenario solid place unit exposure value from the CMA data is for workers wearing longsleeved shirts and long pants. Lacking better data for this task, this value has been used. The calculated short term dermal and inhalation MOEs for this task are 11,000 and 110,000 respectively   greater than the target MOE value of 100. Page 25 of 45 Table 14. Calculation of Short term Dermal Dose from Handling of Toilet Bowl Tablets Parameter Value Rationale Maximum Application Rate 0.08 lb/ tablet EPA Assumption % a. i. in Formulated Product 98 Maximum concentration listed on product label Quantity Used Daily 3 tablets EPA Assumption Dermal Absorption Factor 100 EPA Assumption Inhalation Absorption Factor 100 EPA Assumption Dermal Unit Exposure 10.8 mg/ lb a. i. CMA surrogate data for solid placement of tablets Inhalation Unit Exposure 0.257 mg/ lb a. i. CMA surrogate data for solid placement of tablets Dermal NOAEL 390 mg/ kg/ day Inhalation NOAEL 100 mg/ kg/ day Daily Dermal Exposure 2.58 mg a. i./ day ( Appl. Rate) * (% a. i. / 100) * ( Qty) * ( Derm. Abs. Factor / 100) * ( Dermal UE)

Daily Dermal Dose 0.036 mg/ kg/ day ( Daily Derm. Exp.) / 70 kg Dermal MOE 10,830 ( Derm. NOAEL) / ( Daily Derm. Dose). Target MOE = 100.

Daily Inhalation Exposure 0.064 mg a. i./ day ( Appl. Rate) * (% a. i. / 100) * ( Qty) * ( Inhal. Abs. Factor / 100) * ( Inhal UE)

Daily Inhalation Dose 0.00091 mg/ kg/ day ( Daily Inhal. Exp.) / 70 kg Page 26 of 45 Inhalation MOE 110,000 ( Inhal. NOAEL) / ( Daily Inhal. Dose). Target MOE = 100.

4.1.3 Painting Scenario Two painting scenarios have been analyzed in this assessment: a homeowner using a brush or roller to paint a house, and a homeowner using an airless sprayer to paint a house. The exposures associated with both of these painting scenarios were determined using procedures described in the Residential SOPs ( USEPA, 2000b). In following these procedures, a number of assumptions have been made.

° For paints used with a brush or roller, the amount of paint used is 2 gallons. This is based on a 90th percentile value of 8 gallons of latex paint used per year divided by the mean frequency of 4 painting events per year ( USEPA, 1997). ° Weight fraction of ai in paint is based on EPA Reg. No. 6836 271. Maximum of 2 percent by weight of product is added to paint of which 52.4 percent is active ingredient attributed to dihalodialkylhydantoin. ° For painting with an airless sprayer, a homeowner is assumed to use three 5 gallon cans of readyto use product ( i. e., 15 gallons). This is based on a coverage rate of 200 ft2/ gallon and a house size of 40x30x20 ft ( surface area of 2,800 ft2) ( USEPA, 2000b). ° Surrogate data from PHED were used for the dermal and inhalation unit exposures. ° The density of the paint was assumed to be 1.24 g/ mL or 10 lbs/ gallon.

The assumptions used and the calculation of potential short term dermal dose and dermal MOE are shown in Table 15. All MOEs calculated for painting scenarios are greater than the target MOE of 100. Page 27 of 45 Table 15. Short term Risks Associated with Residential Use of Dihalodialkylhydantoin ( in Painting Scenarios)

Parameter Brush/ Roller Airless Sprayer Rationale Maximum Application Rate 2 gallons/ day 15 gallons/ day EPA Assumption Weight fraction of a. i. in product 0.01048 0.01048 Maximum concentration listed on 6836 271 Paint Density 1.24 g/ mL 1.24 g/ mL EPA Assumption Dermal Unit Exposure 230 mg/ lb a. i. 79 mg/ lb a. i. PHED surrogate data Inhalation Unit Exposure 0.28 mg/ lb a. i. 0.83 mg/ lb a. i. PHED surrogate data Dermal NOAEL 390 mg/ kg/ day 390 mg/ kg/ day Inhalation NOAEL 100 mg/ kg/ day 100 mg/ kg/ day Daily Dermal Dose 0.69 mg/ kg/ day 1.8 mg/ kg/ day ( Appl. Rate) * ( Wt. Fraction) * ( Density) * ( Dermal UE) * ( 1/ 70)* ( Conversion Factors)

Dermal MOE 570 220 ( Derm. NOAEL) / ( Daily Derm. Dose). Target MOE = 100.

Daily Inhalation Dose 0.00084 mg/ kg/ day 0.019 mg/ kg/ day ( Appl. Rate) * ( Wt. Fraction) * ( Density) * ( Inhal. UE) * ( 1/ 70)* ( Conversion Factors)

Inhalation MOE 120,000 5,400 ( Inhal. NOAEL) / ( Daily Inhal. Dose). Target MOE = 100.

4.2 Residential Postapplication Exposure Typically, most products used in a residential setting result in exposures occurring over a short term time duration ( 1   30 days). If the products are used on a routine basis ( i. e., once a week) and the active ingredient has a long indoor half life, exposures may occur over an intermediate term time duration ( 30 days   6 months). However, AD does not have residue dissipation data or reliable use pattern data including the frequency and duration of use of antimicrobial products used in the residential setting. Therefore, even though AD does not believe that the use patterns of many Page 28 of 45 residential products result in intermediate term exposure, they are assessed to provide an upper bound estimate of exposure ( e. g., day care centers). It should be noted that data resulting from the work of industry based task forces such as AEJV should provide reliable use pattern estimates. These data will help determine the necessity of continuing to assess intermediate term exposures for residential products.

For the purposes of this screening level assessment, postapplication scenarios have been developed that encompass multiple products but still represent a high end scenario for all products represented. Table 16 shows the postapplication scenarios considered in this assessment. Two scenarios have been considered: exposed to residue from hard floors that have been cleaned/ mopped with a generic cleaner containing dihalodialkylhydantoin, and exposure to residue on clothing that has been treated with dihalodialkylhydantoin during textile processing. For this screening level assessment, fabric softeners has been grouped with textile processing chemicals for calculating exposure.

Table 16. Residential Postapplication Scenarios Handler Scenario Products Represented Toddler exposed to residue from a hard floor Hard surface cleaner/ floor Adult and toddler exposed to residue on clothing Textile processing chemicals, fabric softener 4.2.1 Hard Surface/ Floor Dermal Exposure:

There is the potential for dermal exposure to toddlers crawling on hard floor surfaces. To determine toddler exposure to floor residues ( mopping), the following equation was used:

PDD FR x SA BW =

where: PDD = Potential daily dose FR = Flux rate of chemical from material ( mg/ m2/ day) SA = Surface area of the body which is in contact with the floor ( m2) BW = Body weight ( kg)

Due to limited data, a number of conservative assumptions have been made:

$ Toddlers ( 3 years old) are used to represent the 1 to 6 year old age group and are assumed to weigh 15 kg, the median for male and female toddlers ( USEPA, 2000b). A body surface area of 0.657 m2 has been assumed, which is the median value.

$ Generic household cleaners are commercially available in a large range of concentrations. It is assumed that one gallon of treatment solution ( 0.0026 lb ai/ gallon mopping solution   see handler section above for determination of concentration) can treat 1000 ft2 of floor. Page 29 of 45 ° No data could be found regarding the quantity of treatment solution residue left on the floor after treatment. It has been assumed that 25% of the solution remains after the final mop. ° No leaching data were available that could be used to estimate the residue transfer from the hard surface ( i. e., floor). Therefore, the Residential SOP estimate of 10 percent of the amount on the floor is available for dermal transfer.

The calculation of the short and intermidate term dermal dose and the dermal MOE are shown in Table 17. The dermal MOE ( short and intermediate term dermal endpoint is the same) is not of concern ( MOE = 700). Page 30 of 45 Table 17. Short and Intermediate term Dermal Risks Associated with Postapplication Exposure to a General Household Cleaner ( Floor Mop).

Parameter Value Rationale Application Rate 1,000 ft2/ gallon of mop solution USEPA Assumption % a. i. in Formulated Product 52.4% Maximum rate listed on label (# 6836 271)

% Formulated Product in Generic Household Cleaner 2% Maximum rate listed on label (# 6836 271)

Density of Moping Solution 1.0 g/ mL Assumed to be similar to density of water Dermal Transfer Rate ( TR) of Chemical from Floor 12.7 mg/ m2/ day ( Equivalent to 1.27

g/ cm2) ( Density 8 lb/ gal) * ( 52.4% a. i.) * ( 2% Formulated Product) * 25% remaining after mop * 10% transfer / ( App. Rate) * ( Conversion Factors)

Surface Area of Body in Contact with Carpet 0.657 m2 Median surface area of toddler Body Weight 15 kg Median body weight of toddler Potential Dermal Exposure 0.56 mg/ kg/ day TR * SA / BW Dermal NOAEL 390 mg/ kg/ day Dermal MOE 700 ( Derm. NOAEL) / ( Daily Derm. Dose). Target MOE = 100.

Hand to Mouth Transfer:

In addition to dermal exposure, toddlers crawling on treated floors will also be exposed to dihalodialkylhydantoins via incidental oral exposure through the hand to mouth activity. To calculate incidental ingestion exposure to dihalodialkylhydantoins due to hand to mouth transfer, the scenarios established in the Standard Operating Procedures ( SOPs) for Residential Exposure Assessments were used. These scenarios use assumptions that are similar to those used in calculating exposures due to dermal contact of dihalodialkylhydantoins from toddlers crawling on treated floors. The assumptions above in the dermal assessment ( Table 17) estimates the transferable residues as 1.27 µ g/ cm2 . The estimated potential ingestion dose rate immediately after application would be calculated as follows: Page 31 of 45 PDR norm= ISR t x SA x FQ x SE x ET x 0.001 mg/ µ g BW where:

PDR norm = Potential dose rate ( mg/ kg/ day); ISR t = Indoor Surface Residue ( µ g/ cm2) at time 0; SA = Surface area of the hands that contact both the treated area, and the individuals mouth ( cm2/ event); FQ = Frequency of hand to mouth events ( events/ hr); SE = Saliva extraction efficiency of 50 percent, and, ET = Exposure Time ( 4 hrs/ day) BW = Body weight ( 15 kg)

The surface area used for each hand to mouth event is 20 cm2 . It is assumed that there are 20 hand to mouth exposure events per hour ( 90th percentile). The short term incidental oral NOAEL is 500 mg/ kg/ day and the intermediate term NOAEL is 300. The potential dose rate ( PDR) using this equation is 0.07 mg/ kg/ day resulting in a hand to mouth MOEs for toddlers of 7,100 ( short term) and 4,300 ( intermediate term).

4.2.1 Clothing/ Textile Although dihalodialkylhydantoins has been listed for use in textile processing, it is unclear in what capacity the chemical is to be used. It has been assumed, for this risk assessment, that the chemical is impregnated into the material in the same manner as a dye would impregnated. To determine dermal and/ or incidental oral exposure to impregnated clothing, the following equation was used:

PDD FR x SA BW =

where PDD = Potential daily dose FR = Flux rate of chemical from material ( mg/ m2/ day) SA = Surface area of the body which is in contact with clothing or mouthed ( m2) BW = Body weight ( kg)

Data on which these calculations could be based were generally unavailable; therefore, a number of conservative assumptions have been made:

° Toddlers ( 3 years old) are used to represent the 1 to 6 year old age group and are assumed to weigh 15 kg, the median for male and female toddlers ( USEPA, 2000b). The median surface area for a 3 year old, minus the head, is 0.657 m2. Median values for body weights and surface areas for adults have been used ( 70 kg and 1.69 m2, not including head surface area). ° Based on rough estimates provided by the American Association of Textile Chemists and Colorists ( AATCC), dyes are used on fabric at a rate of about 4% by weight ( AATCC, 2003). A mediumsized polo cotton shirt of regular knit construction weighs about 250 g. Assuming that the shirt Page 32 of 45 covers 0.659 m2 of the body's surface area ( based on the mean adult surface area for the torso, including the neck ( USEPA, 1997)), the cloth weight to surface area ratio is 379 g/ m2. If an adult wears clothing of a similar weight over all parts of the body, minus the head ( 1.69 m2 ( USEPA, 1997)), then the weight of clothing worn by an adult is 641 g. Using the same cloth weight to surface area ratio, the weight of clothing worn by a toddler is 214 g. Area mouthed, for lack of data, is assumed to be equivalent to the area of fingers used in the hand to mouth exposure estimates ( i. e., 20 cm2 or 20 cm2 / 10,000 = 0.002 m2).

$ No leaching data were available that could be used to estimate a flux rate of the chemical from clothing. It has been conservatively assumed that, over the course of a day, the amount of chemical transferred is the full quantity of chemical present in the clothing. This is a conservative assumption and should not be considered as representative of the true rate at which the chemical would be transferred. However, as a screening level assessment the risks are not of concern.

The calculation of the dermal dose and the dermal MOE are shown in Table 18. The dermal MOEs calculated for both toddler and adult scenarios are not of concern ( MOEs = 119 and 185 for toddlers and adults, respectively). The short term incidental oral MOE, as a result of mouthing treated fabric, is not of concern ( MOE = 45,000). The short term incidental oral NOAEL was used instead of the intermediate term NOAEL because all of the residues were assumed to be available for exposure in one day ( for lack of any residue data). Page 33 of 45 Table 18. Short and Intermediate term Risks Associated with Postapplication Exposure to Impregnated Clothing Parameter 3 yr old Toddler Adult Rationale Body Weight 15 kg 70 kg Median body weight Surface area, minus head 0.567 m2 1.69 m2 Median surface area Surface area of cloth mouthed 0.002 m2 NA No data, hand to mouth assumption Cloth weight to surface area ratio 379 g/ m2 Based on regular knit cotton fabric Weight of clothing worn 214 g 641 g ( CW to SA ratio) * SA worn Weight of clothing mouthed 0.76 g NA ( CW to SA ratio) * SA mouthed % dye used in fabric 4% by weight AATCC estimate % a. i. in Formulated Product 57.3% Maximum rate listed on label (# 6836 306)

% Formulated Product in Dye 1.00% Maximum rate listed on label (# 6836 306)

Density of dye 1.0 g/ mL Assumed to be similar to density of water Quantity of a. i. Transferred to Individual ( dermal) 49.0 mg/ day 147 mg/ day ( Clothing weight worn) * (% Dye) * (% Form. Prod.) * (% a. i.) * ( Conv. Factor)

Daily Dermal Dose 3.27 mg/ kg/ day 2.10 mg/ kg/ day ( Qty. a. i.) / ( Body Weight, 15 kg or 70 kg)

Quantity of a. i. Orally Transferred to Individual ( incidental oral) 0.17 NA ( cloth weight mouthed) * (% dye)*(% product in dye)*(% ai in product)*( 1000 mg/ g unit conversion)

Incidental Oral Ingestion dose ( mouthing) 0.011 mg/ kg/ day NA ( Qty. a. i.) / ( 15 kg BW)

Dermal NOAEL 390 mg/ kg/ day Oral NOAEL 500 mg/ kg/ day Dermal MOE 119 185 ( NOAEL) / ( Dose). Target MOE = 100.

Incidental Oral MOE ( mouthing) 45,000 NA ( NOAEL) / ( Dose). Target MOE = 100. Page 34 of 45 5.0 AGRICULTURAL PREMISES AND AQUATIC AREA USES ( HANDLER AND POSTAPPLICATION)

One agricultural premise use and one aquatic area use have been identified.

° Solid pour/ place of product into chemigation systems, ° Solid pour of product into vehicle and foot baths at greenhouse entrances.

The chemical can also be applied via irrigation systems on ornamental plants grown in greenhouses of nurseries for the control of algal and microbial slimes ( EPA Registration Number 5785 70). Irrigation systems include misted fog overhead sprinkler systems, flood, hydroponics, and capillary mat systems. Use of dihalodialkylhydantoin in chemigation systems is via loading of a brominator feed system, through which the product is dispensed via dissolution as feed water is passed through the tank. For irrigation systems, the label states that 1 ounce of granules should be added per 100 gallons, but that additional dihalodialkylhydantoin should be added until there is a residual of 10 to 35 ppm bromine initially, and 5 to 15 ppm bromine after the system is clean. The dosage for vehicle and foot baths, according to the label, is " 1 oz. per 100 gallons of water to maintain a bromine level of 15 to 50 ppm." For lack of better data, an application rate of 1 oz/ 100 gallons per day has been assumed for both scenarios. The percent active ingredient for all products for use in these scenarios is 96 percent.

The amount of dihalodialkylhydantoin that will be used in the irrigation systems will depend greatly on the size of the greenhouse/ nursery and the amount of irrigation necessary for the particular crop/ climatic conditions. The amount of footbaths that should be used for the assessment is also in question. From anecdotal evidence, 1 gal of water is used for each footbath, and 1" of water use for irrigation can be assumed. It has also been assumed that, for chemigation, the product will be used on 10 acres of crop. From these assumptions, a use rate of 270,000 gallons has been calculated.

The calculated MOEs are shown in Table 19. All MOEs calculated are above the Agency's level of concern ( MOEs< 100). No postapplication exposures were considered. Page 35 of 45 Table 19. Short and Intermediate term Risks Associated with Agricultural Premises and Aquatic Areas Uses Exposure Scenario Method of Application Clothing Attire Dermal Unit Exposure ( mg/ lb ai) a Inhalation Unit Exposure ( mg/ lb ai) b Appl.

Rate ( lb a. i./

gal) c Amount Treated ( gallons) Absorbed Dermal Dose ( mg/ kg/ day) d Dermal MOE e Inhalation Dose ( mg/ kg/ day) f Inhalation MOE g Aquatic Areas Greenhouse and Nursery Irrigation Systems Solid Place Long pants,

long sleeved shirt,

chemical resistant gloves 11.9 0.257 0.000625 270,000 27.5 14.2 0.595 168 Solid Pour 0.466 0.0125 0.000625 270,000 1.08 362 0.0289 3460 Solid Place Long pants,

longsleeved shirt, no gloves NA 0.257 0.000625 270,000 NA NA 0.595 168 Solid Pour 76.2 0.0412 0.000625 270,000 176 2.21 0.0953 1050 Agricultural Premises Greenhouse Foot Bath Solid Pour Long pants,

long sleeved shirt,

chemical resistant gloves 0.466 0.0125 0.000625 5 0.00002 19,500,000 0.000000536 187000000 Long pants,

longsleeved shirt, no gloves 76.2 0.0412 0.000625 5 0.00327 119000 0.00000177 56600000 a, b Dermal and inhalation unit exposures are from CMA study. Cooling tower scenario is used for the ` solid place' scenarios to be conservative. Because inhalation unit exposure values were not available for the ungloved scenario ( solid place), the inhalation unit exposure values for the gloved scenario were used.

c Application rates are based on the dihalodialkylhydantoin labels.

d Abs. dermal dose ( mg/ kg/ day) = [ unit exposure ( mg/ lb ai) * dermal absorption ( 1.0) * Appl. rate ( lb ai/ gallon) * gallons handled / Body weight ( 70 kg).

e MOE = NOAEL ( mg/ kg/ day) / Daily Dose [ Where short and intermediate term dermal NOAEL = 390 mg/ kg/ day]. Target MOE is 100.

f Inhalation dose ( mg/ kg/ day) = [ unit exposure (

g/ lb ai) * 0.001 mg/

g unit conversion * max appl rate ( lb ai/ gal) * gallons handled * 1 inhalation absorption]

/ Body weight ( 70 kg).

g MOE = NOAEL ( mg/ kg/ day) / Inhalation Dose [ Where short and intermediate term inhalation NOAEL = 100 mg/ kg/ day]. Target MOE is 100. Page 36 of 45 6.0 Limitations and Uncertainties There are a number of uncertainties associated with this assessment. In general, conservative values were used in cases where data were lacking to develop screening level assessments.

Industrial Processes and Water Systems ° Surrogate dermal and inhalation data from Chemical Manufacturers Association ( CMA) database were used to assess handler exposure. Note that CMA surrogate data have the following deficiencies:

The inhalation concentrations were typically below the detection limits, so the unit exposures for the inhalation exposure route could not be accurately calculated.

The quality of the CMA data were assessed using the same grading criteria as PHED and the grades were all at C, D, E lower than PHED standards ( e. g., most of PHED is at grades A, B, C).

Grade C, D, E data frequently may have QA/ QC problems including lack of either/ or field fortification, laboratory recoveries, and storage stability information.

Grade C, D, E data have an insufficient amount of replicates.

Grade C, D, E data may have higher variabilities ( e. g., high CVs).

° The estimates used for the amount of water maintained by workers for cooling water systems and pulp and paper process systems comes from Dang, 1996. It is unclear from the study what method was used to calculate the values. The estimate for once through cooling water systems was used as a surrogate for all other industrial processes/ water systems.

Material Preservatives and Commercial/ Institutional Premises ° Very little data could be found regarding typical amounts handled by workers in manufacturing settings for material preservatives and workers in commercial/ institutional premises. It is unclear whether the values used reflect typical amounts handled by workers.

Swimming Pools / Spas $ Surrogate dermal and inhalation data from Chemical Manufacturers Association ( CMA) database were used to assess handler exposure. These data were not originally meant for use in calculating risks for swimming pool handlers.

$ Calculation for the swimming pool scenarios rely on the use of SWIMODEL, a model which has the following limitations:

SWIMODEL focuses on potential chemical intakes only. It does not account for metabolism or Page 37 of 45 excretion of the chemical of concern.

SWIMODEL does not predict or calculate chemical concentration values in exhaled air or blood. Therefore, biological monitoring results cannot be directly compared or related to SWIMODEL outputs.

SWIMODEL uses the following absorption factors for each route of exposure:

 Ingestion: 100% absorption of ingested chemical assumed  Dermal: Uses a chemical specific dermal permeability coefficient ° Dermal exposure estimates are predicated on a one compartment model of the skin. The ratelimiting step is penetration of the stratum corneum. The model uses Fick's Law of Diffusion to calculate a general exposure value, without regard for differences in the skin permeability of specific body parts.

Residential and Public Access Premises $ Surrogate dermal and inhalation data from Chemical Manufacturers Association ( CMA) database were used to assess handler exposure. These data were not originally meant for use in calculating risks for residential scenarios. Clothing scenarios differ significantly between the CMA study ( long sleeved shirt, long pants) and the residential exposure scenario ( short sleeved shirt, short pants).

Agricultural Premises and Aquatic Areas ° There is considerable uncertainty as to the use rates used in the agricultural / aquatic area scenarios. The values used are based on anecdotal evidence. Page 38 of 45 7.0 REFERENCES American Association of Textile Chemists and Colorists. 2003. Phone conversation with Tricia Day, Technical Assistant, July 2003.

Brown, C. 2002. Water Use in the Professional Car Wash Industry. Published by International Carwash Association, Inc.

Clearon Corp. Material Safety Data Sheet for Halogene G. http:// www. dsbg. com/ Brome/ brome. nsf/ 0a03dde88bb2d9c7422567760036799d/ c1a588a37cc806a942 256c2a003ea436/$ FILE/ 8424GU_ EN MTR CLRR. pdf, last accessed March, 2003.

Clements, JB. 2003. The In Bay Automatic: An Additional Profit Center. http:// www. wonderwash wonderlube. com/ aln_ nov96. doc, last accessed February, 2003.

Dang, W. 1996. Antimicrobial Pesticides, Uses, Human Exposures, and Risk Assessments. March, 1996. Draft.

USEPA. 1997. Exposure Factors Handbook. Volume I II. Office of Research and Development. Washington, D. C. EPA/ 600/ P 95/ 002Fa.

USEPA. 1999. Evaluation of Chemical Manufacturers Association Antimicrobial Exposure Assessment Study. Memorandum from Siroos Mostaghimi, Ph. D., USEPA, to Julie Fairfax, USEPA. Dated November 4, 1999. DP Barcode D247642.

USEPA. 2000a. Dihalodialkylhydantoin  2nd Report of the Hazard Identification Assessment Review Committee. Dated August 28, 2000. HED Doc. No. 014298.

USEPA. 2000b. Residential SOPs. EPA Office of Pesticide Programs   Human Health Division. Dated April 5, 2000.

USEPA, 2002. Pesticide Product Information System. http:// www. epa. gov/ opppmsd1/ PPISdata/ index. html, last accessed September 2002. Page 39 of 45 APPENDIX: EPA Registration Numbers for Dihalodialkylhydantoin Products Page 40 of 45 Table A1. EPA Registration Numbers for Dihalodialkylhydantoin Products, Grouped by Industrial Uses Use Category Formulation EPA Registration Numbers Recirculating Cooling Water Tablet / Briquette 1448 356,  420 3576 150, 5785 62,  63,  100 6836 113,  115,  210,  237 66397 1 5185 42 Gel 5185 487 Granular 6836 280 8622 29 5785 65 5785 70 Wettable Powder 8622 28 Ready to Use Solution 3377 71,  62 5185 483 6836  120,  121,  122,  123,  124 8622 30 5785 57 Once Through Cooling Water Tablet / Briquette 1448 356,  420 3576 150, 5785 62,  63, 6836 115,  210,  237 5185 420 Gel 5185 487 Granular 6836 280 8622 29 5785 65 Wettable Powder 8622 28 Ready to Use Solution 3377 71 5185 483 8622 30 5785 57 Page 41 of 45 Table A1. EPA Registration Numbers for Dihalodialkylhydantoin Products, Grouped by Industrial Uses Use Category Formulation EPA Registration Numbers Wastewater Treatment Tablet / Briquette 1448 356 5785 63, 6836 113,  115,  237 5185 420 Granular 5785 65 Ready to Use Solution 5185 483 3377 71 Air Washer Tablet / Briquette 6836 113,  115,  210,  237 Granular 6836 280 Ready to Use Solution 3377 71 Photo Processing Wash Water Tablet / Briquette 6836 115,  237 5185 420 Granular Pulp and Paper Process Water Tablet 5785 63, 6836 113,  115,  282,  297,  237 5185 420 Granular 2836 280, 6836 281,  296 5785 65 Ready to Use 3377 71 5785 57 6836 307 47371 190 Cannery Water Systems Gel 5185 487 Ready to Use Solution 5185 483 Page 42 of 45 Table A1. EPA Registration Numbers for Dihalodialkylhydantoin Products, Grouped by Industrial Uses Use Category Formulation EPA Registration Numbers Evaporative Cooler Gel 5185 487 Tablet / Briquette 1448 356 5785 63,  100 5185 420 Ready to Use Solution 5185 483 Table A2. EPA Registration Numbers for Dihalodialkylhydantoin Products, Grouped by Commercial/ Institutional Premises Uses Use Category Formulation EPA Registration Numbers Air Conditioner / Humidifier Drip Pans Tablet / Briquette 1448 420 5785 63,  100 5185 420 8622 29 Ready to Use Solution 8622 30 Ornamental Fountains Tablet / Briquette 1448 420 Ready to Use Solution 3377 71 8622 30 Transportation Cleaning Tablet / Briquette 6836 210 Page 43 of 45 Table A3. EPA Registration Numbers for Dihalodialkylhydantoin Products, Grouped by Swimming Pool Uses Use Category Formulation EPA Registration Numbers Swimming Pool Granular 6836 250 Tablet / Briquette 5185 378,  420 7616 66 1729 132 7124 104 6836 118 66397 2,  3 57787 24 8622 41 Ready to Use Solution 67262 23 3377 61,  72 Soluble Concentrate 6836 211 Spas and Hot Tubs Granular 6836 251 Tablet / Briquette 66397 1,  2 5185 377,  420,  421 7124 103 7616 66 1729 104,  153,  132, 6836 116 57787 24 8622 41 Ready to Use Solution 3377 61,  72 53735 10 67262 23 5185 480,  433,  480,  483 6836 243 Soluble Concentrate 6836 211 Page 44 of 45 Table A4. EPA Registration Numbers for Dihalodialkylhydantoin Products, Grouped by Residential Uses Use Category Formulation EPA Registration Numbers Detergent and Soap Soluble / Flowable Concentrate 6836 119,  200,  207, 271 ,  306 47371 189 Ready to Use 6836 111,  199,  200 Adhesives Soluble / Flowable Concentrate 6836 119,  271 47371 188 Carpet Shampoo Soluble / Flowable Concentrate 6836 306 Caulk Soluble / Flowable Concentrate 6836 119,  271 47371 188 Ready to Use 6836 200 Household Cleaning Products Soluble / Flowable Concentrate 6836 271 Ready to Use 6836 199,  200 Textile Processing Chemicals Soluble / Flowable Concentrate 6836 119, 271,  306 Fabric Softener Soluble / Flowable Concentrate 6836 119,  271,  306 Ready to Use 6836 199,  200 Deodorizer Soluble / Flowable Concentrate 6836 119,  207, 271,  306 47371 189 Ready to Use 6836 199,  200 Water based gels for household and industrial products Soluble / Flowable Concentrate 6836 119,  207,  306 47371 189 Ready to Use 6836 199,  200 Paint Soluble / Flowable Concentrate 6836 119,  207,  271 47371 188 Ready to Use 6836 200 In Tank Sanitizer Tablet / Briquette 5185 446,  469 5813 66,  65 6836 251,  256,  255,  263,  264,  265,  279,  272, Page 45 of 45 Table A5. EPA Registration Numbers for Dihalodialkylhydantoin Products, Grouped by Agricultural Uses Use Category Formulation EPA Registration Numbers Foot Baths Granular 5785 70 Table A6. EPA Registration Numbers for Dihalodialkylhydantoin Products, Grouped by Aquatic Area Uses Use Category Formulation EPA Registration Numbers Chemigation Granular 5785 70 Tablet 5785 69 Table A7. EPA Registration Numbers for Dihalodialkylhydantoin Products used for Reformulation and Repackaging Use Category Formulation EPA Registration Numbers Reformulation Formulation Intermediate 8622 26,  27 Granular 1729 128,  129 Powder 6836 109,  110,  114,  117 Liquid 6836 112,  208 Tablet 1729 130 Technical Chemical 5185 452,  454,  455,  456,  457 8622 25 3377B63


[Federal Register Volume 76, Number 60 (Tuesday, March 29, 2011)]
[Notices]
[Pages 17462-17463]
[FR Doc No: 2011-7265]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-64112; File No. SR-ISE-2011-14]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change Relating to Fees for Qualified Contingent Cross Orders

March 23, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on March 14, 2011, the International Securities Exchange, LLC (the
``Exchange'' or the ``ISE'') filed with the Securities and Exchange
Commission the proposed rule change, as described in Items I, II, and
III below, which items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The ISE is proposing to amend its fee schedule to establish fees
for a new order type called Qualified Contingent Cross. The text of the
proposed rule change is available on the Exchange's Web site (http://www.ise.com), at the principal office of the Exchange, and at the
Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of these statements may be examined at
the places specified in Item IV below. The self-regulatory organization
has prepared summaries, set forth in sections A, B and C below, of the
most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The purpose of the proposed rule change is to establish fees for a
new order type called Qualified Contingent Cross (``QCC''). The QCC
order type was recently approved by the Commission.\3\ The Exchange now
proposes to adopt fees related to this new order type. Specifically,
the Exchange proposes to extend the same pricing that currently applies
to orders entered into the facilitation, solicitation and price
improvement mechanism on behalf of firm proprietary, Non-ISE Market
Makers \4\ and Professional Order participants,\5\ which amounts to
$0.20 per contract for QCC orders in all option classes traded on the
Exchange.
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    \3\ See Securities Exchange Act Release No. 63955 (February 24,
2011) (SR-ISE 2010-73).
    \4\ The term ``Non-ISE Market Maker'' means a market maker as
defined in Section 3(a)(38) of the Securities Exchange Act of 1934
registered in the same options class on another options exchange.
See ISE's Schedule of Fees.
    \5\ The term ``Professional Order'' means an order that is for
the account of a person or entity that is not a Priority Customer.
See ISE Rule 100(37C).
---------------------------------------------------------------------------

    The fee for ISE Market Makers that participate in a QCC order will
be charged either $.18 \6\ or $.20, \7\ depending upon the product.\8\
---------------------------------------------------------------------------

    \6\ The rate of $.18 remains unchanged for ISE Market Makers
participating in all symbols other than those set forth in footnote
5 [sic].
    \7\ ISE Market Makers and Market Maker Plus are charged a higher
rate of $.20 when participating in a QCC order in these select
symbols: QQQQ, C, BAC, SPY, IWM, XLF, GE, JPM, INTC, RIMM, T, VZ,
UNG, FCX, CSCO, DIA, AMZN, X, AA, AIG, AXP, BBY, CAT, CHK, DNDN,
EEM, EFA, EWZ, F, FAS, FAZ, FSLR, GDX, GLD, IYR, MGM, MS, MSFT, MU,
PBR, PG, POT, RIG, SDS, SLV, XLE, XOM, ABX, BMY, BP, COP, DELL, FXI,
HAL, IBM, KO, LVS, MCD, MO, MON, NOK, ORCL, PFE, QCOM, S, SLB, SMH,
SNDK, TBT, USO, V, VALE, WFT, XLI, XRT, YHOO, AKAM, AMD, AMR, APC,
BA, BRCM, GG, HPQ, LCC, MOT, NEM, NFLX, NVDA, QID, SSO, TEVA, TLT,
TZA, UAL, WFC, XLB, SIRI, SBUX and VVUS.
    \8\ Priority Customers are currently not charged when
participating in orders executed in the facilitation, solicitation
and price improvement mechanism. Consistent with the Exchange's
approach, this will be extended to Priority Customers when
participating in QCC orders.
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2. Statutory Basis
    The Exchange believes that its proposal to amend its Schedule of
Fees is consistent with Section 6(b) of the Act \9\ in general, and
furthers the objectives of Section 6(b)(4) of the Act \10\ in
particular, in that it is an equitable allocation of reasonable dues,
fees and other charges among Exchange members. The Exchange believes
that the fees proposed for QCC orders are reasonable because QCC orders
are similar to facilitation and solicitation orders in that the members
have both sides of the order and are entering the order onto the
exchange for execution. Members are currently charged $.20 for
executions of facilitation and solicitation orders and because QCC
orders have a similar composition, it is reasonable that the Exchange
is proposing to extend the same fee to QCC orders. The Exchange
believes that the proposed fee is equitable in that this fee is applied
consistently across all memberships and client categories, except for
ISE Market Makers in certain circumstances. The Exchange believes that
it is equitable to allow ISE Market Makers a lower transaction fee in
certain circumstances because ISE Market Makers are differentiated from
other members in that they have negative and affirmative obligations to
the market place.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78f(b).
    \10\ 15 U.S.C. 78f(b)(4).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The proposed rule change does not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\11\ At any time within 60 days of the
filing of such proposed rule change, the Commission summarily may
temporarily suspend such rule change if it appears to the Commission
that such action is necessary or appropriate in the public interest,
for the protection of investors, or otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or disapproved.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(3)(A)(ii).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-ISE-2011-014 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-ISE-2011-014. This file
number should be included on the subject line if e-mail is used.
    To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for website
viewing and printing in the Commission's Public Reference Room on
official business days between the hours of 10 a.m. and 3 p.m. Copies
of such filing also will be available for inspection and copying at the
principal offices of the Exchange. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-ISE-2011-014, and should be submitted on or before April
19, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
---------------------------------------------------------------------------

    \12\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Cathy H. Ahn,
Deputy Secretary.
[FR Doc. 2011-7265 Filed 3-28-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 49 (Wednesday, March 13, 2013)]
[Notices]
[Pages 15955-15956]
[FR Doc No: 2013-05721]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0221]

Draft Guidance for Industry and Review Staff on Formal Dispute
Resolution: Appeals Above the Division Level; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry and review staff entitled
``Formal Dispute Resolution: Appeals Above the Division Level.'' This
guidance is intended to provide recommendations for industry on the
procedures in the Center for Drug Evaluation and Research (CDER) and
the Center for Biologics Evaluation and Research (CBER) for resolving
scientific and procedural disputes that cannot be resolved at the
division level. This guidance describes procedures for formally
appealing such disputes to the office or center level and providing
information to assist FDA officials in resolving the issue(s)
presented. This guidance revises the guidance of the same name issued
in February 2000.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by June 11, 2013.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002, or
the Office of Communication, Outreach and Development (HFM-40), Center
for Biologics Evaluation and Research, Food and Drug Administration,
1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448. Send one
self-addressed adhesive label to assist that office in processing your
requests. The draft guidance may also be obtained by mail by calling
CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Amy Bertha, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 6469, Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or,
Sheryl Lard-Whiteford, Center for Biologics Evaluation and Research
(HFM-4), Food and Drug Administration, 1401 Rockville Pike, Rockville,
MD 20852-1448,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
and review staff entitled ``Formal Dispute Resolution: Appeals Above
the Division Level.'' In the course of drug review, CDER and CBER make
a wide variety of scientific and procedural decisions that are critical
to a sponsor's drug development program. Sometimes, a

sponsor may disagree with one of these decisions, and a dispute arises.
Because these disputes often involve complex scientific or procedural
matters and also may be precedent setting, it is critical that there be
procedures in place to encourage open, prompt discussion of such
disputes. The procedures and policies described in this guidance are
intended to promote rapid resolution of scientific and procedural
disputes between sponsors and FDA. This draft guidance is a revision of
the guidance of the same name that published in February 2000. The
procedures and policies have been updated to reflect the current
practices.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on formal
dispute resolution regarding appeals above the division level. It does
not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternative approach may be used
if such approach satisfies the requirements of the applicable statutes
and regulations.

II. The Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in this draft guidance have been approved
under OMB control number 0910-0430. This draft guidance is a revision
of an earlier version of the guidance. The revised version contains no
additional information collections; therefore, it continues to be
covered under OMB control number 0910-0430.

III. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov.

    Dated: March 7, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-05721 Filed 3-12-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 86, Number 83 (Monday, May 3, 2021)]
[Notices]
[Page 23397]
[FR Doc No: 2021-09178]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4592-DR; Docket ID FEMA-2021-0001]

Kentucky; Amendment No. 1 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the Commonwealth of Kentucky (FEMA-4592-DR), dated March 31, 2021,
and related determinations.

DATES: This amendment was issued April 8, 2021.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the Commonwealth of Kentucky is hereby amended to include the
following area among those areas determined to have been adversely
affected by the event declared a major disaster by the President in his
declaration of March 31, 2021.

    Taylor County for Public Assistance.

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050 Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.)

Robert J. Fenton,
Senior Official Performing the Duties of the Administrator, Federal
Emergency Management Agency.
[FR Doc. 2021-09178 Filed 4-30-21; 8:45 am]
BILLING CODE 9111-23-P