PHMB Occupational/ Residential Exposure Assessment CASE 3122 PC CODE 111801 February 3, 2005 Timothy Leighton, Ph. D.

Cassi Walls, Ph. D.

Office of Pesticide Programs Antimicrobials Division U. S. Environmental Protection Agency 1200 Pennsylvania Avenue, NW Washington, DC 20460 2 EXECUTIVE SUMMARY The Occupational and Residential Exposure Chapter of the poly( hexamethylenebiguanide)

hydrochloride ( PHMB) Reregistration Eligibility Decision ( RED) addresses potential exposures and risks to humans who may be exposed to PHMB in " occupational settings" and the general population in residential settings. In particular, the following exposed populations have been identified: ( 1) handlers ( mixers, loaders, applicators) of PHMB products; and ( 2) individuals who are involved in post application or reentry activities. At this time, EPA does not have available chemical specific handler or postapplication exposure studies to support PHMB. Therefore, inhalation and dermal exposures were addressed for occupational populations using surrogate data from the Chemical Manufacturers Association ( CMA), the Pesticide Handlers Exposure Database ( PHED), and several studies which relate to the use patterns of PHMB. Using surrogate unit exposure data, application rates from labels, and EPA estimates of daily amount handled, exposure and risks to handlers and post application workers were assessed.

The registrant for PHMB has indicated that ~ 95 percent of the use of this chemical is for pools and spas ( PHMB SMART Meeting). However, it should be noted that there are many registered use categories for this chemical in addition to its use in pools and spas. The handler scenarios considered in this assessment are summarized in tabular format to follow. These scenarios were selected based on examination of product labels describing uses for the product.

PHMB Handler Scenarios Category Scenario Material Preservatives Pouring PHMB industrial preservative into vats or tanks of slurry containing leather processing fluids, silicones, adhesives, mineral slurries, etc.

Food Handling/ Storage Establishments Premises and Equipment Pouring PHMB preservative into vats or tanks for tunnel pasteurization.

Industrial Processes and Water Systems Pouring or pumping PHMB preservative into vats or tanks for preservation of oil well injection fluids, mud packer solutions, and workover solutions.

Swimming Pools Pouring PHMB biocide/ sanitizer/ algae control preservatives into pools or spas.

Residential and Public Access Premises PHMB is used as a disinfectant to spray, mop and wipe surfaces throughout the kitchen, bath and other areas of the house. Category Scenario 3 Medical Premises and Equipment PHMB is used in a spray, wipe and mop to sterilize surfaces as a hospital cleaner disinfectant and medical equipment. Disinfectants are applied by spray, mopping and wiping.

Handlers The exposure and risk assessments were conducted using labeled rates with standard useinformation and CMA and/ or PHED unit exposure data. After performing the exposure assessment, EPA determined that the greatest potential for exposure appears to be the dermal scenarios involving: pour liquid for drilling muds ( dermal MOE = 74 and inhalation MOE = 370) and pour liquid for workover fluids ( dermal MOE = 74 and inhalation MOE = 370). In order to achieve MOEs above the target level ( i. e., greater than 100), scenarios involving drilling muds and workover fluid must use mitigation measures such as metering pump systems. Calculated MOEs using the pump liquid scenario are greater than the target MOEs. As the mitigation measure brings the inhalation MOE above 1,000 ( which includes the additional 10x route to route extrapolation), no confirmatory inhalation toxicity study is needed. All of the other occupational uses of PHMB are not of concern using open pouring techniques.

Among the residential and commercial handlers, use of PHMB did not trigger risks of concern for the spray/ mop/ wipe and swimming pool/ spa applications.

Post application Residential post application exposures to children playing on treated floors and swimming in treated pools/ spas ( adults too) are considered in this assessment. MOEs are greater than the target MOE ( 100) for residential post application exposure to adults and children in swimming pools, child hand

tomouth ingestion after crawling on mopped floors, and dermal exposure to children playing on treated floors after mopping. 4 1.0 BACKGROUND Purpose In this document, which is for use in EPA's development of the PHMB Reregistration Eligibility Decision Document ( RED), EPA presents the results of its review of the potential human health effects of occupational and residential exposure to PHMB.

Criteria for Conducting Exposure Assessments An occupational and/ or residential exposure risk 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 PHMB, both criteria are met.

2.0 Summary of Toxicity Concerns Relating to Occupational and Residential Exposures Acute Toxicology Categories The toxicological database for PHMB is adequate and will support re registration eligibility.

Toxicity categories for PHMB are shown in Table 1.

Table 1. Acute Toxicity Categories for 20% PHMB Test Results Toxicity Category Acute Oral Toxicity LD50= 2,747 mg/ kg III Acute Dermal Toxicity LD50 > 5.0 mg/ kg III Acute Inhalation Toxicity None

Primary Eye Irritation Severe Eye Irritant I Primary Dermal Irritation Severe Dermal Irritant I Dermal Sensitization Moderate Sensitization  5 Selection of Toxicological Endpoints The PHMB Hazard Identification Assessment Review Committee ( HIARC) report ( dated April 18, 2001) indicates that there are toxicological endpoints for PHMB ( U. S. EPA, 2001a). Table 2 summarizes these endpoints.

Table 2. Toxicological Endpoints for Assessing Occupational and Residential Exposures/ Risks Exposure Scenario Dose Used in Risk Assessment, UF Special FQPA SF* and Level of Concern for Risk Assessment Study and Toxicological Effects Acute Dietary ( Females 13 50 years of age) NOAEL = 20 mg/ kg/ day UF = 100 Acute RfD = 0.2 mg/ kg/ day FQPA SF = 1 aPAD = acute RfD FQPA SF = 0.2 mg/ kg/ day Rabbit Developmental Study ( MRID 42865901)

LOAEL = 40 mg/ kg/ day based on reduced number of litters and skeletal abnormalities.

Acute Dietary ( General population including infants and children) No Appropriate single dose effects was identified for general population Chronic Dietary ( All populations) NOAEL= 20 mg/ kg/ day UF = 100 Chronic RfD =

0.2 mg/ kg/ day FQPA SF = 1 cPAD =

chronic RfD FQPA SF = 0.2 mg/ kg/ day Rabbit Developmental Study ( MRID #:

42865901)

LOAEL = 40 mg/ kg/ day Based on the increased mortality, reduced food consumption, and clinical toxicity;

Mouse Developmental Study ( Report No.

CTL/ P/ 335, 1977 ( cited in Report No.

003810, 1978. Section C 9))

LOAEL = 40 mg/ kg/ day;

Based on reduced body weight gain; and Rat Developmental Study ( Report No.

CTL/ P/ 1262, 1976 ( cited in Report No.

003810, 1978. Section C 11))

LOAEL = 50 mg/ kg/ day Based on reduced food consumption. Exposure Scenario Dose Used in Risk Assessment, UF Special FQPA SF* and Level of Concern for Risk Assessment Study and Toxicological Effects 6 Short Term Incidental Oral ( 1 30 days) NOAEL= 20 mg/ kg/ day UF = 100 Residential LOC for MOE =

100 Occupational = NA See Chronic RfD Intermediate Term Incidental Oral ( 1 6 months) NOAEL= 20 mg/ kg/ day UF = 100 Residential LOC for MOE =

100 Occupational = NA See Chronic RfD Short Term,

Intermediate Term,

and Long Term Dermal Exposure Dermal ( or oral) study NOAEL= 150 mg/ kg/ day UF = 100 ( Relative dermal absorption rate = 100%) Residential LOC for MOE = 100 Occupational LOC for MOE = 100 80 Week Dermal Painting Study ( MRIDs 00066475 and 00104796)

LOAEL = 750 mg/ kg/ day based on decreased body weight and liver tumors.

Short Term,

Intermediate Term,

and Long Term Inhalation Exposure An appropriate route specific inhalation study is not available. The oral endpoint of 20 mg/ kg/ day with a Target MOE of 100 ( 10x inter species extrapolation, 10x intra species variation) is used. An additional 10x route to route extrapolation is used to determine if a confirmatory inhalation toxicity study is warranted.

Cancer ( oral, dermal) The HED Cancer Assessment Review Committee. ( CARC) classified PHMB as " Suggestive Evidence of Carcinogenicity, but not sufficient to Assess Human Carcinogenic Potential" by the oral and dermal routes.

Quantification of human cancer risk is not required.

UF = uncertainty factor, FQPA SF = FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level, PAD = population adjusted dose ( a = acute, c = chronic) RfD = reference dose, LOC = level of concern, MOE = margin of exposure Dermal Absorption A dermal absorption factor was not needed because the dermal toxicity is based on a dermal study.

3.0 Handler Exposures and Risks EPA has determined that there exists a potential for exposure to mixers, loaders, applicators, or other handlers during usual use patterns associated with PHMB. There are potential exposures from use in industrial settings as well as commercial and residential uses of products. At the PHMB SMART Meeting, the registrant indicated that ~ 95 percent of the use of this chemical is for pools and spas.

However, there are many other registered use categories for this chemical in addition to its use in pools and spas. 7 3.1 Occupational Handlers Based on the use patterns, EPA has identified PHMB products that are used in the following use site categories ( USC):

° Material Preservatives;

° Food Handling/ Storage Establishments Premises and Equipment;

° Industrial Processes and Water Systems;

° Swimming Pools;

° Residential and Public Access Premises; and ° Medical Premises and Equipment.

Table 3 provides a description of exposure scenarios for the general categories of occupational handlers ( e. g., open pour for Material Preservatives).

3.2 Residential Handlers Based on the use patterns, EPA has identified the four major exposure scenarios for residential handlers including:

° Open pouring for swimming pools/ spas;

° Spraying ( aerosol and/ or trigger pump sprays) disinfectants;

° Mopping with disinfectants; and ° Wiping with disinfectants.

Table 3 provides a description of exposure scenarios for the general categories of occupational handlers ( e. g., spray/ mop/ wipe for Residential and Public Access Premises). 8 Table 3. Exposure Scenarios for Occupational Handlers Use Site Categories Scenario Descriptions Data Source Material Preservatives Silicones and Aqueous Industrial Chemicals; Leather Processing Preservation of Fresh Animal Hides and Skins; Preservation of Cellulosic Fibers and Textiles; Aqueous Based Polymer Latices; Aqueous Mineral Slurries; Aqueous Based Adhesives;

Industrial Electrocoats; and Household Consumer Products Scenario encompasses a variety of uses,

including preservatives added to silicones and aqueous industrial chemicals, leather processing, etc. 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. CMA data for general preservatives for pour liquid are used as the most conservative measure of upper bound exposure.*

( CMA, 1992; U. S. EPA 1999).

Food Handling/ Storage Establishments Premises and Equipment Tunnel Pasteurization Scenario encompasses use of antimicrobial additive in the preservation waters of canned and bottled food and drink. Exposure occurs when pouring or pumping using metering systems by filling of bulk tanks, contact with pipes, or hoses or setup/ maintenance of the automated metering system. CMA data for general preservatives for pour liquid are used as the most conservative measure of upper bound exposure.*

( CMA, 1992; U. S. EPA 1999).

Industrial Processes and Water Systems Oil Well Injection Systems Drilling Muds, and Workover Fluids Drilling muds and preservatives are used to prevent microbial degradation of the starch component of fresh water drilling fluids and to stop the toxic corrosive hydrogen sulfide production. The primary function of a workover fluid is to control formation pressure, transport movable solids and minimize formation damage. Packaging for the liquid is in 55 gallon drums and bulk tanks ranging from 110 to 550 gallons. The products are poured in or fed by chemical pumps specifically designed for this purpose. CMA data for general preservatives for pour liquid and pump liquid is used ( CMA, 1992; U. S. EPA 1999).

Swimming Pools Pools and Spas Spas PHMB can be used as a chlorine free biocide, a sanitizer, and for control of algae in pools. Exposure occurs when pouring or pumping using metering systems. Exposure occurs either via pouring or pumping using automated metering systems. CMA data for general preservatives for pour liquid are used.* ( CMA, 1992; U. S. EPA 1999).

Residential and Public Access Premises All Purpose Cleaner PHMB is used as a cleaner in residential settings via sprays, mopping, and wiping. PHED data for sprays and CMA data for wiping/ mopping ( CMA, 1992; U. S. EPA 1999).

Medical Premises and Equipment Disinfectants ( Sprays, Mopping, and Wipes) PHMB is used in a wipe to sterilize surfaces and medical equipment. Disinfectants are applied by spray, mopping and wiping. PHED data for sprays and CMA data for wiping/ mopping. ( CMA, 1982, U. S. EPA, 1999).

* Pump liquid is not assessed because the calculated MOE for pouring is greater than the target MOE. 9 3.3 Handler Data and Assumptions In the course of development of this Reregistration Eligibility Decision document ( RED), limited handler exposure data were available. In the absence of PHMB chemical specific data, surrogate data from the Chemical Manufacturers Association ( CMA, 1992) were used to estimate unit exposure. PHMB labeling information along with EPA estimates were used to determine the approximate amount handled per day. These data were used to predict handler exposures for the various scenarios.

Chemical Manufacturers Association ( CMA) Data In response to an EPA Data Call In Notice, a study was undertaken by the Institute of Agricultural Medicine and Occupational Health of The University of Iowa under contract to the Chemical Manufacturers Association. In order to meet the requirements of Subdivision U of the Pesticide Assessment Guidelines ( superseded by Series 875.1000 875.1600 of the Pesticide Assessment Guidelines), handler exposure data are required from the chemical manufacturer specifically registering the antimicrobial pesticide. The applicator exposure study must comply with the assessment guidelines for " Applicator Exposure Monitoring" in Subdivision U and the " Occupational and Residential Exposure Test Guidelines" in Series 875. For this purpose, CMA submitted a study on 28 February, 1990, entitled " Antimicrobial Exposure Assessment Study ( amended on December 8, 1992)" which was conducted by William Popendorf, et al. It was evaluated and accepted by Occupational and Residential Exposure Branch ( OREB) of Health Effect Division ( HED), Office of Pesticides Program ( OPP) of EPA in 1990.

The purpose of this CMA study was to characterize exposure to antimicrobial chemicals in order to support pesticide reregistrations ( CMA, 1992). The unit exposures presented in the most recent EPA evaluation of the CMA database ( U. S. EPA, 1999) were used in this assessment.

The Agency determined that the CMA study had fulfilled the basic requirements of Subdivision U  Applicator Exposure Monitoring. The advantages of CMA data over other " surrogate data sets" is that the chemicals and the job functions of mixer/ loader/ applicator were defined based on common application methods used for antimicrobial pesticides. A few of the deficiencies in the CMA data are noted below:

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

° QA/ QC problems including lack of field fortification, laboratory recoveries, and/ or storage stability information.

° Data have an insufficient amount of replicates.

The Pesticide Handlers Exposure Database ( PHED) 10 The Pesticide Handlers Exposure Database ( PHED) has been developed by a Task Force consisting of representatives from Health Canada, the U. S. Environmental Protection Agency ( EPA), and the American Crop Protection Association ( ACPA). PHED provides generic pesticide worker ( i. e.,

mixer/ loader and applicator) exposure estimates. The dermal and inhalation exposure estimates generated by PHED are based on actual field monitoring data, which are reported generically ( i. e., chemical specific names not reported) in PHED. It has been the Agency's policy to use " surrogate" or " generic" exposure data for pesticide applicators in certain circumstances because it is believed that the physical parameters ( e. g., packaging type) or application technique ( e. g., aerosol can), not the chemical properties of the pesticide, attribute to exposure levels. [ Note: Vapor pressures for the chemicals in PHED are in the range of E 5 to E 7 mmHg.] Chemical specific properties are accounted for by correcting the exposure data for study specific field and laboratory recovery values as specified by the PHED grading criteria.

PHED handler exposure data are generally provided on a normalized basis for use in exposure assessments. The most common method for normalizing exposure is by pounds of active ingredient ( ai)

handled per replicate ( i. e., exposure in mg per replicate is divided by the amount of ai handled in that particular replicate). These unit exposures are expressed as mg/ lb ai handled. This normalization method presumes that dermal and inhalation exposures are linear based on the amount of active ingredient handled.

Estimated Amount Handled Table 4 provides the assumptions used to estimate the amount of PHMB handled per day. The estimated amounts handled per day were used in conjunction with data from CMA and PHED to yield exposure estimates for handlers in various scenarios.

It should be noted that according to the registrant ( MRID 440513 01) PHMB is not marketed for use in public swimming pools. Instead, PHMB is assessed using a typical residential swimming pool capacity of 20,000 gallons. In addition, in MRID 440513 01, the registrant estimates that the upper end of the range for amount of pools that a pool maintenance worker can treat in one day is 20 pools.

However, the market share of PHMB in residential pools is not believed to be 100 percent. Therefore,

even if one assumed that the PHMB market share for treating residential pools is 50 percent, the maximum number of pools treated per day would be 10 ( i. e., 10 pools/ day x 20,000 gallons/ pool =

200,000 gallons treated daily, which is also believed to be representative of the volume of a typical public pool).

Table 4. Exposure Estimates/ Assumption for the Daily Amount of Preservative Handled Table 4. Exposure Estimates/ Assumption for the Daily Amount of Preservative Handled ( Continued)

11 Exposure Scenarios Pounds Active Ingredient Used Occupational Handlers ( 1) Open Pour Liquids for Material Preservation Scenario encompasses a variety of uses including preservatives added to silicones and aqueous industrial chemicals, leather processing, etc. Exposure occurs when pouring or using a metering system. Exposure occurs either via loading and filling of bulk tanks, contact with pipes, 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. PHMB can be added as a general preservative in adhesives, caulks, coatings. Assumes 10,000 pounds of slurry ( e. g., adhesives, coatings, emulsions, etc) are treated per day. Labels indicate the following:  Silicones and Aqueous Industrial Products. Dosage is listed as 1 to 50 lb Vantocil ® per 10,000 lb product. Using maximum rate ( 50 lbs) and assuming 1,000 to 10,000 lb of product treated, the total amount of active ingredient ( 20% ai) is 1 to 10 lb.  Leather Processing. Dosage is listed as 1 to 30 lb Vantocil ® per 10,000 lb product. Using the maximum rate ( 30 lb) and assuming 1,000 to 10,000 lb of product treated, the total amount of active ingredient ( 20% ai) is 0.6 to 6 lb.  Aqueous Based Polymer Latices. Dosage is listed as 5 to 50 lb Vantocil ® per 10,000 lb product. Using the maximum rate ( 50 lb) and assuming 1,000 to 10,000 lb of product treated, the total amount of active ingredient ( 20% ai) is 1 to 10 lb.  Animal Skins and Hides. Dosage is listed as 1 to 2.6 lb Vantocil ® per 1,000 lb of hides. Using the maximum rate ( 2.6 lb) and assuming 1,000 to 10,000 lb of hides treated, the total amount of active ingredient ( 20% ai) is 0.52 to 5.2 lb.  Cellulosic Materials and Textiles. Dosage is listed as 0.025 2% based on the dry weight of the product. Using the maximum rate and assuming 1,000 to 10,000 lb of product treated, the total amount of active ingredient ( 20% ai) is 4 to 40 lb.  Aqueous Mineral Slurries. Dosage is listed as 5 to 50 lb Vantocil ® per 10,000 lb product. Using the maximum rate and assuming 1,000 to 10,000 lb of product treated, the total amount of active ingredient ( 20% ai) is 1 to 10 lb.  Aqueous Based Adhesives. Dosage is listed as 5 to 50 lb Vantocil ® per 10,000 lb product. Using the maximum rate and assuming 1,000 to 10,000 lb of product treated, the total amount of active ingredient ( 20% ai) is 1 to 10 lb.  Industrial Electrocoats. Dosage is listed as 5 to 50 lb Vantocil ® per 10,000 lb product. Using the maximum rate and assuming 1,000 to 10,000 lb of product treated, the total amount of active ingredient ( 20% ai) is 1 to 10 lb.  Household Consumer Products. Dosage is listed as 2.5 to 25 lb Vantocil ® per 10,000 lb product ( 250 2,500 ppm). Using the maximum rate and assuming 1,000 to 10,000 lb of product treated, the total amount of active ingredient ( 20% ai) is 0.5 to 5 lb.

( 2) Open Pour Liquids for Food Handling/ Storage Equipment Premises Biocides are added to preserve the water used in tunnel pasteurization and tunnel cooling of sealed packages of canned and bottled foodstuffs. The Agency typically assumes 1000 to 10,000 ( 3,785 37,850 liters) gallons of tunnel pasteurization water are produced per day. Labels indicate that 100 1000 ppm active ingredient are added in the diluted fluid. Using the maximum dose rate on the label, approximately 3,785 to 37,850 grams of ai are used per day ( 8.34 83.4 lb ai per day). Exposure Scenarios Pounds Active Ingredient Used 12 ( 3) Open Pour Liquids and Pump Liquids for Industrial Processes and Water Systems Biocides are added to preserve oil well injection water, drilling muds, and workover fluids. The Agency typically assumes 1,000 barrels ( 42,000 gallons or 158,987 liters) handled per day for oil well injection systems, drilling muds, and workover fluids. The maximum slug treatment to oil injection waters is 4 gallons of Vantocil ® per 1,000 barrels or 95 ppm. Using the maximum dose on the label, this means that approximately 15,103 grams of ai are used per day ( 3.3 lb ai per day). For drilling muds and workover fluids, the maximum dose on the label is 126 gallons of Vantocil ® per 1,000 barrels or 3,000 ppm. Using the maximum dose on the label, approximately 476,961 grams of are used per day ( 1,052 lb ai per day).

Commercial and Residential Handlers ( 1) Open Pour Liquids for Swimming Pools ( Commercial treaters) Biocide added to multiple residential pools by a commercial swimming pool company. The Agency assumes that a typical residential swimming pools capacity is 20,000 gallons. The pool is treated at a maximum rate of 50 ppm. Using the maximum dose on the label, approximately 1,000 grams are used per day ( 2.2 lb ai per day). For commercial treaters of residential pools ( i. e., pool company), an upper bound estimate of the amount of PHMB used is estimated as 22 lb ai per day ( i. e., 10 residential pools treated per day).

( 2) Open Pour Liquids for Swimming Pools ( Residential pools) Biocide added to a single residential pool by a homeowner. The Agency assumes that a typical swimming pools capacity is 20,000 gallons. The pool is treated at a maximum rate of 50 ppm. Using the maximum dose on the label, approximately 1,000 grams are used per day ( 2.2 lb ai per day) for a single pool.

( 3) Pump Spray Disinfectant ( Residential and Medical Premises) PHMB is used as a general purpose cleaner ( e. g EPA Reg 71661 1). EPA Reg 71661 1 indicates a concentration of 0.56%. It is assumed that 1 liter is sprayed per day for the medical applications and that the product has a density of 1 gm/ mL. Therefore the amount handled would be 5.6 gm ai or 0.012 lb ai per day. For the residential use, it is assumed that the maximum used would be 0.5 liters or 0.006 lb ai/ day.

( 4) Disinfectant Mopping ( Residential and Medical Premises) EPA Reg. 71661 1 indicates a concentration of 0.56% and the density is assumed to be 1 gm/ mL. Assuming that 2 gallon ( 3.78 L) mop bucket is used per day in medical premises, the amount handled would be 21.2 gm ai or 0.047 lb ai per day. One gallon is assumed for residential uses ( 0.023 lb ai/ day).

( 5) Disinfectant Wiping ( Residential and Medical Premises) A specific label for the wipes was not used, instead it is assumed that the application rate is similar to that of EPA Reg. 71661 1. Assuming that 1 liter is used per day in medical premises for wiping, the amount handled would be 5.6 gm ai or 0.012 lb ai per day. ½ liter is assumed for residential uses ( 0.006 lb ai/ day).

3.4 Handler Risk Assessment and Characterization Exposure estimates for occupational handlers are presented in Table 5. The CMA study data are considered to be the most appropriate estimates for the unit exposures associated with the antimicrobial uses of PHMB. The CMA study reports two risk mitigation methods ( open pouring of liquid/ solids and 13 pump metering liquid). These two risk mitigation methods are both reported in Table 5. This assessment traditionally assumes that the body weight of adults is 70 kg. CMA and PHED data were used to assess dose calculations. PHED estimates are limited to the aerosol can spray.

Dermal Daily Dose The dermal daily dose in Tables 5 and 6 was calculated using the following formula:

where:

Unit Exposure ( mg ai/ lb ai) = Values obtained from CMA ( CMA, 1992), PHED ( PHED, 1997), or Residential SOPs ( U. S. EPA,

1997a)

Use Rate = Values from Table 4 Amount Handled ( lb/ day or gal/ day) = Values from Table 4 Body weight ( kg) = 70 kg 14 Table 5. Short, Intermediate, and Long Term Exposures and Risks to Occupational Handlers from PHMB Uses Dermal Exposurea ( mg/ lb ai) Baseline Inhalation Unit Exposurea ( mg/ lb ai) App. Rateb ( lb ai) Dermal c Dermal d Inhalation c OCCUPATIONAL Use Site Daily Daily Daily Inhalation d Inhalation Dermal PRIMARY USES Category Description Exposure Dose Exposure Daily Dose MOE MOE e Application Method ( mg/ day) ( mg/ kg/ day) ( mg/ day) ( mg/ kg/ day)

Material Preservatives Liquid pour Silicons and Aqueous Industrial Products 0.135 0.00361 1 0.135 0.00193 0.00361 0.0000516 390,000 77,700 0.135 0.00361 10 1.35 0.0193 0.0361 0.000516 39,000 7,770 Leather Processing 0.135 0.00361 0.6 0.0810 0.00116 0.00217 0.0000310 650,000 129,000 0.135 0.00361 6 0.810 0.0116 0.0217 0.000310 65,000 12,900 Aqueous Based Polymer Latices 0.135 0.00361 1 0.135 0.00193 0.00361 0.0000516 390,000 77,700 0.135 0.00361 10 1.35 0.0193 0.0361 0.000516 39,000 7,770 Animal Skins and Hides 0.135 0.00361 0.52 0.0702 0.00100 0.00188 0.0000268 750,000 150,000 0.135 0.00361 5.20 0.702 0.0100 0.0188 0.000268 75,000 15,000 Cellulosic Materials and Textiles 0.135 0.00361 4 0.54 0.00771 0.0144 0.000206 97,000 19,500 0.135 0.00361 40 5.40 0.0771 0.144 0.00206 9,700 1,950 Aqueous Mineral Slurries 0.135 0.00361 1 0.135 0.00193 0.00361 0.0000516 390,000 77,700 0.135 0.00361 10 1.35 0.0193 0.0361 0.000516 39,000 7,770 Aqueous Based Adhesives 0.135 0.00361 1 0.135 0.00193 0.00361 0.0000516 390,000 77,700 0.135 0.00361 10 1.35 0.0193 0.0361 0.000516 39,000 7,770 Industrial Electrocoats 0.135 0.00361 1 0.135 0.00193 0.00361 0.0000516 390,000 77,700 0.135 0.00361 10 1.35 0.0193 0.0361 0.000516 39,000 7,770 Household Consumer Products 0.135 0.00361 0.5 0.0675 0.000964 0.00181 0.0000258 750,000 156,000 0.135 0.00361 5 0.675 0.00964 0.0181 0.000258 75,000 15,600 Food Handling/ Storage Premises and Equipment Liquid Pour Tunnel Pasteurization 0.135 0.00361 8.34 1.13 0.0161 0.0301 0.000430 47,000 9,320 0.135 0.00361 83.4 11.3 0.161 0.301 0.00430 4,700 932 Industrial Processes and Water Systems Liquid Pour Oil Injection Waters 0.135 0.00361 3.3 0.446 0.00637 0.0119 0.000170 120,000 23,500 Drilling Muds 0.135 0.00361 1052 142 2.03 3.80 0.0543 370 74 Workover Fluids 0.135 0.00361 1052 142 2.03 3.80 0.0543 370 74 Liquid Pump Drilling Muds 0.00629 0.000403 1052 6.62 0.0946 0.424 0.00606 3,300 1,590 Workover Fluids 0.00629 0.000403 1052 6.62 0.0946 0.424 0.00606 3,300 1,590 a Unit exposures based on CMA data for inhalation and dermal exposure. Data represent single layer clothing and no gloves.

b Application Rate based on label information and assumptions on daily amounts handled.

c Dermal/ Inhalation Exposure ( mg/ day)= Unit Exposure ( mg/ lb ai) * Application Rate ( lb ai).

d Dermal/ Inhalation Dose ( mg/ kg/ day)= Dermal or Inhalation Exposure ( mg/ day)/ Body Weight ( 70 kg).

e Dermal MOE= Dermal NOAEL ( 150 mg/ kg/ day)/ Dermal Dose ( mg/ kg/ day). Target MOE = 100. 15 Table 6. Short, Intermediate, and Long Term Exposures and Risks to Residential and Commercial Handlers from PHMB Uses RESIDENTIAL HANDLERS/ SECONDARY OCCUPATIONAL USES Dermal Unit Exposure ( mg/ lb ai) Baseline Inhalation Unit Exposure ( mg/ lb ai) App.

Rate ( lb ai) Dermal Daily Exposure ( mg/ day) Dermal Daily Dose ( mg/ kg/ day) Inhalation Daily Exposure ( mg/ day) Inhalation Daily Dose ( mg/ kg/ day) Dermal MOE Inhalation MOE Use Site Application Method Category Description Liquid Pour Swimming Pools ( commercial treater) 0.135 0.00361 22 2.97 0.0424 0.0794 0.00113 3,535 18,000 Liquid Pour Swimming Pools ( residential) 0.135 0.00361 2.2 0.297 0.00424 0.00794 0.000113 35,000 180,000 Medical Premises and Equipment Spray Disinfectant ( Consumer Product) 190 1.3 0.012 see dose 0.033 see dose 2.2E 4 4,600 91,000 Mopping Disinfectant ( Consumer Product) 71.6 2.38 0.047 see dose 0.048 see dose 0.0016 3,100 13,000 Wiping Disinfectant ( Consumer Product) 2870 67.3 0.012 see dose 0.492 see dose 0.012 300 1,700 Residential and Public Access Spray Disinfectant ( Consumer Product) 220 ( shorts) 1.3 0.006 see dose 0.019 see dose 1.1E 4 8,000 180,000 Mopping Disinfectant ( Consumer Product) 71.6 2.38 0.023 see dose 0.024 see dose 0.00078 6,400 26,000 Wiping Disinfectant ( Consumer Product) 2870 67.3 0.006 see dose 0.25 see dose 0.0058 610 3,400 Footnotes:

a Unit exposures based on PHED and CMA data for inhalation and dermal exposure. Data represent single layer clothing and no gloves ( residential spray based on short pants and short sleeved shirt   PHED and HED's Residential SOPs) .

b Application Rate based on label information and assumptions on daily amounts handled.

c Dermal/ Inhalation Exposure ( mg/ day)= Unit Exposure ( mg/ lb ai) * Application Rate ( lb ai).

d Dermal/ Inhalation Dose ( mg/ kg/ day)= Dermal or Inhalation Exposure ( mg/ day)/ Body Weight ( 70 kg).

e Dermal MOE= Dermal NOAEL ( 150 mg/ kg/ day)/ Dermal Dose ( mg/ kg/ day). Target MOE = 100 16 Inhalation Daily Dose Potential daily inhalation dose was calculated using the following formula:

where:

Unit Exposure ( mg ai/ lb ai) = Values obtained from CMA ( CMA, 1992),

PHED ( PHED, 1997), or Residential SOPs ( U. S. EPA, 1997a).

Use Rate ( lb ai) = Values from Table 4 Amount Handled ( lb/ day or gal/ day) = Values from Table 4 Body weight ( kg) = 70 kg ( adults)

The calculations of the daily dermal and inhalation doses of PHMB received by handlers are used to assess the dermal risk to handlers. The MOEs were calculated using a dermal NOAEL of 150 mg/ kg/ day and an oral NOAEL of 20 mg/ kg/ day for inhalation ( route to route extrapolation). The following formula describes the calculation of an MOE:

MOE = NOAEL mg kg / day Daily Dose ( mg / kg / day)

Handler Non Cancer Risks from Dermal and Inhalation Exposures to PHMB For PHMB, a MOE greater than the target MOE ( 100) is an indication that there is no risk concern for short term, intermediate term, and chronic exposures.

The exposure and risk assessments were conducted using the maximum use rates stated on the labels with standard use information and CMA and/ or PHED unit exposure data. After performing the exposure assessment, EPA determined that the greatest potential for exposures appears to be in scenarios involving: pour liquid for drilling muds ( dermal MOE = 74 and inhalation MOE = 370); and pour liquid for workover fluids ( dermal MOE = 74 and inhalation MOE = 370). In order to achieve MOEs above the target level ( i. e., dermal greater than 100), scenarios involving drilling muds and workover fluid must use 17 mitigation measures such as using metering pump systems. Calculated dermal MOEs using the pump liquid scenario are greater than the target MOE ( i. e., dermal MOE= 1,600 and inhalation MOE = 3,300).

As the mitigation measure brings the inhalation MOE above 1,000 ( which includes the additional 10x route to route extrapolation), no confirmatory inhalation toxicity study is needed. MOEs for workers in medical premises using PHMB as a disinfectant for spraying, mopping, and wiping do not present risks of concern ( dermal MOEs = 4,600, 3,100, and 300 while inhalation MOEs = 91,000, 13,000, and 1,700,

respectively). MOEs for scenarios involving pouring PHMB liquid into swimming pools and spas for a commercial treater treating 10 residential pools per day are greater than the target MOEs ( dermal MOE =

3,500 and inhalation MOE = 18,000).

The calculations of short, intermediate, and long term inhalation and dermal risk for residential handlers using the disinfectant cleaners indicate no risks of concern ( for dermal: spraying MOE = 8,000,

mopping MOE = 6,400, and wiping MOE = 610; and for inhalation spraying = 180,000, mopping MOE =

26,000, and wiping MOE = 3,400). Finally, a homeowner pouring PHMB into a single swimming pool does not pose a risk of concern ( dermal MOE= 35,000 and inhalation MOE = 180,000). All calculated MOEs for these scenarios were greater then the target MOE.

4.0 Post Application Assessment In the course of development of this exposure chapter for the Reregistration Eligibility Decision ( RED), limited residential exposure data were available. Most of the information provided for this part of the risk assessment were provided by studies performed by the registrant. These studies focus largely on the potential of increased susceptibility of infants and children from exposure to PHMB, as required by the Food Quality Protection Act ( 1996). FQPA sets an explicit standard for assessing risks from potential exposures to children. EPA must determine whether exposures to pesticides are safe for children and includes an additional safety factor for children, considering special sensitivities and exposures to pesticide chemicals. Specifically, FQPA requires EPA to give special consideration to exposure to " ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue."

Based on the use patterns, EPA has identified residential post application exposure scenarios for the swimming pool/ spa use along with the hard surface cleaners. The exposure scenarios that are considered representative of the high end exposures associated with PHMB include:

° Dermal exposure and ingestion of PHMB via swimming in treated pools for adults and children.

° Dermal contact and incidental ingestion ( i. e., hand to mouth residue transfer) resulting from toddlers crawling on floors after mopping. 18 Descriptions of these scenarios are presented in Table 7.

Table 7. Residential Exposure Scenarios Use Site Categories Scenario Descriptions Data Source Swimming Pools Pools are treated with PHMB ( biocide/ sanitizer/ control growth of algae) Adults and children are exposed via dermal contact to swimming pool water and ingestion. Risk calculations have been performed for both competitive swimmers and non competitive swimmers. SWIMODEL 3.0 Residential and Public Access Disinfectant is applied on counter tops and floors Toddlers may have dermal contact with floors and incidentally ingest disinfectants after mopping. Residential SOP assumptions Potential occupational post application exposures to workers using liquid pumps for drilling muds and handling workover fluids for industrial process and wastewater systems outdoors are expected to be minimal. Neither of these activities has any known associated post application exposures.

4.1 Swimming Pool Use 4.1.1 Dermal Exposure to PHMB through Swimming Pool Use The SWIMODEL 3.0 was developed by EPA as a screening tool to conduct exposure assessments of pesticides found in swimming pools and spas. The SWIMODEL uses well accepted screening exposure assessment equations to calculate the total worst case exposure for swimmers expressed as a mass based intake value ( mg/ event). The model focuses on potential chemical intakes only and does not take into account metabolism or excretion of the chemical of concern. Detailed information and the downloadable executable file are available at http:// www. epa. gov/ oppad001/ swimodel. htm.

Although, the actual model was not used in this assessment, the same equations and default parameters as provided in the SWIMODEL User's Manual ( version 3.0) were used in a spreadsheet format to estimate postapplication dermal and incidental oral exposures.

The following equation was used to develop dermal doses: 19 where:

Dose = Daily dose for pools, ( mg/ kg/ day),

Cw = Chemical concentration in pool water ( mg/ L),

Kp = Permeability constant ( cm/ hr),

SA = Surface area ( cm2),

ET = Exposure time ( hrs/ day),

CF = Conversion factor ( 0.001 L/ cm3)

BW = Body weight ( kg).

The Cw and Kp parameters are chemical specific values whereas, the remaining parameters are based on the default values provided in the SWIMODEL 3.0. The PHMB pool water concentration of 10.4 mg/ L is based on information provided by the registrant ( MRID 44051301) and the permeability constant of 5x10 6 cm/ hr is a measured value also determined by the registrant ( MRID 44046301). It should be noted that since the permeability constant provides estimates of an internal dose from the dermal route of exposure, the oral toxicity endpoint rather than the dermal toxicity endpoint is used to assess the risks from the dermal swimming route. The assumed surface area presented in the SWIMODEL is 1.82 m2 for adults, 1.42 m2 for children ( age 11 14 years), and 1.04 m2 for children ( age 7 10 years). The assumed body weight is 70 kg for adults, 48 kg for children ( age 11 14 years), and 30 kg for children ( age 7 10 years). Exposure time for non competitive swimmers is based on data provided in EPA's Exposure Factors Handbook ( 1997) whereas competitive swimmer exposure time data are based on the Agency's review of the American Chemistry Council ( ACC) study ( ACC, 2002).

It should be noted that this exposure assessment identifies short term ( 1 30 days) and intermediate term ( 1 6 month) noncancer exposure doses based on the reported toxicology endpoints for PHMB. Because of the shorter exposure durations of these toxicological endpoints, conservative eventbased exposure assumptions are used to calculate upper bound daily dose estimates. The noncancer doses are not amortized over a lifetime. For longer term chronic and cancer doses, exposure times and frequencies generated by ACC will likely be considered and adjusted in the SWIMODEL in the future.

The dermal doses for competitive and non competitive adults, children 7 10 yrs, and children 11

14 yrs are presented in Table 8. The parameters used to calculate the dermal exposure are also included in this table. 20 Table 8. Parameters for Dermal Swimming Exposure and Dose Estimate Dermal Adult Adult Child ( 7 10 yrs) Child ( 7 10 yrs) Child ( 11 14 yrs) Child ( 11 14 yrs)

Type of Swimmer Comp. Non

Comp. Comp. Non

Comp. Comp. Non

Comp.

Cw ( mg/ L) 10.4 10.4 10.4 10.4 10.4 10.4 Kp ( cm/ hr) 5E 6 5E 6 5E 6 5E 6 5E 6 5E 6 ET ( hr/ day) 3 5 1 5 2 3 SA ( cm2) 1.82E4 1.82E4 1.04E4 1.04E4 1.42E4 1.42E4 BW ( kg) 70 70 30 30 48 48 CF ( L/ cm3) 0.001 0.001 0.001 0.001 0.001 0.001 Dose ( mg/ kg/ day) 4.06E 5 6.76E 5 1.80E 5 9.01E 5 3.08E 5 4.62E 5 The dermal swimming route is assessed using the oral NOAEL of 20 mg/ kg/ day because the SWIMODEL estimates an internal dose resulting from the dermal route. The target MOE is 100. The equation for calculating the MOE based on the dermal route of exposure is presented below:

Table 9 presents the estimated dose from the dermal route of exposure and the corresponding MOEs based on the oral endpoint for the swimming scenarios for each age group. 21 Table 9. Dermal Dose and MOE for Residential Post Application Swimming Exposure Use Type Scenario Description Dose ( mg/ kg/ day) Dermal MOEa Swimming Pool Adult Competitive 4.06E 5 490,000 Adult Non Competitive 6.76E 5 300,000 Child ( 7 10 yrs)

Competitive 1.80E 5 1,100,000 Child ( 7 10 yrs)

Non Competitive 9.01E 5 220,000 Child ( 11 14 yrs)

Competitive 3.08E 5 650,000 Child ( 11 14 yrs)

Non Competitive 4.62E 5 430,000 aMOE = NOAEL ( mg/ kg/ day)/ Dose ( mg/ kg/ day). Dermal dose for swimmers is an internal dose based on the SWIMODEL results, and therefore, the oral NOAEL of 20 mg/ kg/ day is used.

Target MOE = 100 The calculated results for short, intermediate, and long term exposures and risks indicate that the risks from the dermal route of exposure are not of concern ( MOE> 100) for the post application scenarios developed in this assessment.

4.1.2 Ingestion of PHMB through Swimming Pool Use The following equation was used to develop ingestion doses:

where:

Dose = Daily dose for pools, ( mg/ kg/ day),

Cw = Chemical concentration in pool water ( mg/ L),

IR = Ingestion rate of pool water ( L/ hr),

ET = Exposure time ( hrs/ day),

BW = Body weight ( kg), 22 The PHMB concentration in pool water is based on information provided by the registrant ( MRID 440513 01). The ingestion rates used in the SWIMODEL 3.0 are based on the values used in EPAs Residential SOPs ( USEPA, 2000) and an EPA pilot study as discussed in ACC's swimmer survey ( ACC,

2002). The rest of the assumptions used in calculating the ingestion dose for competitive and non competitive adults and children ( 7 10 yrs and 11 14 yrs) are presented in Table 10 and are consistent with the assumptions used in the dermal assessment.

Table 10. Parameters for Swimming Ingestion Exposure and Dose Estimate Age Adult Adult Child 7 10 yrs Child 7 10 yrs Child 11 14 yrs Child 11 14 yrs Type of Swimmer Comp. Non

Comp. Comp. Non

Comp. Comp. Non Comp.

Cw ( mg/ L) 10.4 10.4 10.4 10.4 10.4 10.4 IR ( L/ hr) 0.0125 0.0125 0.05 0.05 0.025 0.05 ET( hr/ day) 3 5 1 5 2 3 BW( kg) 70 70 30 30 48 48 Dose ( mg/ kg/ day) 0.0056 0.019 0.017 0.087 0.011 0.033 The equation for calculating the oral MOE is presented below:

MOE values calculated for ingestion of PHMB in swimming pool water are presented in Table 11. 23 Table 11. Ingestion Dose and MOE for Residential Swimming Post Application Use Type Scenario Description Dose ( mg/ kg/ day) Ingestion MOE a Swimming Pool Adult, Competitive 0.0056 3600 Adult, Non Competitive 0.019 1100 Child ( 7 10 yrs), Competitive 0.017 1200 Child ( 7 10 yrs), Non Competitive 0.087 230 Child ( 11 14 yrs), Competitive 0.011 1800 Child ( 11 14 yrs), Non Competitive 0.033 620 aMOE = NOAEL mg/ kg/ day/ Dose ( mg/ kg/ day). Oral NOAEL is 20 mg/ kg/ day.

Target MOE = 100 The calculations for intermediate incidental ingestion of PHMB indicate no risk concern for the non competitive or competitive swimming pool scenarios ( i. e., MOE> 100).

4.2 General Purpose Cleaner ( Floor Treatments)

4.2.1 Dermal Contact From Toddlers Crawling On Floors After Mopping There is the potential for dermal exposure to toddlers crawling on treated floors after mopping with PHMB. To determine toddler exposure to residues on treated floors, 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)

The following conservative assumptions were made in calculating the exposures/ risks due to limited data: 24 ° 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.

° The label did not provide information on the volume of disinfectant to be used for cleaning surfaces such as floors. It was assumed that the diluted treatment solution is applied at a rate of 1000 sq. ft. per gallon.

° No data could be found regarding the quantity of solution/ residue left on the floor after treatment. As a conservative measure, it has been assumed that 25% of the mop solution remains after the final mop.

° No leaching data were available that could be used to estimate a flux rate of the chemical from the floor/ hard surface. Therefore, the Residential SOPs estimate of 10% of the amount on the floor/ hard surface available for dermal transfer is used.

According to label information ( EPA Reg 71661 1), this product can be used as a floor cleaner and contains 0.56% active ingredient. Assuming that 1 gallon of solution treats 1000 ft2 and the density is equivalent to water ( 1 g/ mL), the applied amount would be 227 mg/ m2. The SOPs assume that an average of 10% of the application rate is available on the hard surfaces as dislodgeable residues. Additionally, it was assumed that 25% of the formulation remains on the hard surface. Therefore, the indoor surface residue at time zero would be 5.68 mg/ m2. The SOPs also conservatively assume that post application exposure occurs immediately after application.

The calculation of the dermal dose and the dermal MOE are shown in Table 14 . The dermal MOE calculated is above the target MOE of 100 and, therefore, not of concern. 25 Table 12. Short and Intermediate Term Risks Associated with Post Application Dermal Exposure to Disinfectant on Treated Floors.

Parameter Value Rationale Application Rate 1gallon of solution/ 1000 ft2 USEPA Assumption % A. I. in Formulated Product 0.56% Maximum rate listed on label ( 71661 1)

Density of Cleaning Solution 1.0 g/ mL Assumed to be similar to density of water Flux Rate of Chemical from Hard Surface Flooring 5.68 mg/ m2/ day ( App. Rate) *( Density) *

(% A. I.) * ( 25% remaining)*

( 10% transfer) * ( Conversion Factors)

Surface Area of Body in Contact with Hard Surface Flooring 0.657 m2 Median surface area of toddler Body Weight 15 kg Median body weight of toddler Potential Dermal Exposure 0.25 mg/ kg/ day FR * SA * DA/ BW Dermal NOAEL 150 mg/ kg/ day Dermal MOE 600 ( Derm. NOAEL) / ( Daily Derm. Dose). Target MOE = 100.

4.2.2 Incidental Ingestion of PHMB Resulting From Floor Treatments ( Hand to Mouth)

In addition to dermal exposure, infants crawling on treated floors will also be exposed to PHMB via incidental oral exposure. To calculate incidental ingestion exposure to PHMB 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 PHMB from toddlers crawling on floors after mopping.

These assumptions level to an estimate of 0.565 : g PHMB/ cm2 being available for dislodging from the floor. The estimated potential dose rate immediately after application would be calculated as follows:

PDRnorm= ISRt x SA x FQ x SE x ET x 0.001 mg/: g BW where: 26 PDRnorm = Potential dose rate ( mg/ kg/ day);

ISRt = Indoor surface residue (: 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 ( 50%);

ET = Exposure time ( 4 hrs/ day); and 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) for the short term and 9.5 events/ hour ( mean) for the intermediate term duration. The PDR generated in this assessment is an acute estimate of exposure to wet surfaces only. In order to calculate the short term and intermediate term dermal exposure for post application dermal exposures, the proposed data presented by the Hazard Identification Assessment Review Committee ( HIARC) suggests that an oral NOAEL of 20 mg/ kg/ day should be used as the toxicity endpoint for both short and intermediate term incidental ingestion exposures ( U. S. EPA, 2001a). The calculation of the potential dose rate ( PDR) is 0.031 mg/ kg/ day for the short term and 0.014 mg/ kg/ day for the intermediate term duration. The resulting MOEs for toddlers are 660 for the short term and 1,400 for the intermediate term, which are above the target MOE of 100.

5.0 Uncertainties 5.1 Occupational Handler Scenarios Currently, PHMB chemical specific handler or post application exposure studies that meet Agency guidelines have not been identified. Surrogate dermal and inhalation data from the 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 are at grades A, B, C).

° Grade C, D, E data frequently may have QA/ QC problems including lack of field fortification, laboratory recoveries, and/ or storage stability information. 27 ° Grade C, D, E data have an insufficient amount of replicates.

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

5.2 Post Application Scenarios Calculations 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 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 rate limiting 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.

6.0 REFERENCES ACC. 2002. American Chemistry Council ( ACC). An Analysis of the Training Patterns and Practices of Competitive Swimmers. Prepared by Richard Reiss. Sciences International, Inc. Alexandria, Virginia. December 19, 2002.

CMA. 1992. Chemical Manufacturers Association Antimicrobial Exposure Assessment Study. Popendorf, W, Selim, M., Kross, B. The University of Iowa. MRID 425875 01. December 8, 1992.

IT Environmental Programs, Inc., 1991 Chemical Engineering Branch Manual for the Preparation of Engineering Assessments. Contract No. 68 D8 0112. Work Assignment P3 7. U. S. Environmental Protection Agency. Office of Toxic Substances. February 28, 1991.

MRID 440463 01. 14C Polyhexamethylene Biguanide ( PHMB): Absorption Through Human Epidermis and Rat Skin In Vitro. Sponsor Facility: Zeneca Inc. October 15, 1982.

MRID 440513 01. Assessment of Worker and Postapplication Exposure to PHMB Used in Pools and Spas. Sponsor Facility: Zeneca Specialties. Subcontractor: Jellinek, Schwartz, and Connolly, Inc. June 27, 1996. 28 MRID 451877 01. A Health Risk Assessment for PHMB ( Vantocil IB) Used on 100% Cotton Textile Application Systemic Toxicity by an Infant Sucking Textile. Sponsor Facility: Avecia, Inc. August 10, 2001.

PHED. 1997. Surrogate Exposure Guide. Estimates of Worker Exposure from the Pesticide Handler Exposure Database Version 1.1 May 1997.

U. S. EPA. 1997a. Standard Operating Procedures ( SOPs) for Residential Exposure Assessments. Contract No. 68 W6 0030. Prepared by the Residential Exposure Assessment Work Group. Office of Pesticide Programs, Health Effects Division and Versar. July 1997.

U. S. EPA. 1997b. Exposure Factors Handbook. National Center for Environmental Assessment, Office of Research and Development.

U. S. EPA. 2000. Standard Operating Procedures ( SOPs) for Residential Exposure Assessments. Office of Pesticide Programs, Health Effects Division. April 2000.

U. S. EPA. 1999. Evaluation of the Chemical Manufacturers Association Antimicrobial Exposure Assessment Study ( Amended on December 8, 1992). Memorandum from Siroos Mostaghimi, Ph. D., Environmental Engineer to Julie Fairfax, PM # 36. November 4, 1999.

U. S. EPA. 2001a. PHMB  Report of the Hazard Identification Assessment Review Committee. Memorandum from Jonathan Chen, Ph. D., to Norm Cook. April 18, 2001.

U. S. EPA 2001b. Review of a Health Risk Assessment for PHMB ( Vantocil IB) used on 100% Cotton Textile Application  Systemic Toxicity by an Infant Sucking Textile. Memorandum for Siroos Mostaghimi, Ph. D., to Adam Heyward, January 3, 2001.

Versar. 2003. User's Manual Swimmer Exposure Assessment Model ( SWIMODEL) Version 3.0. Prepared for US EPA Antimicrobials Division. November 2003.


[Federal Register Volume 82, Number 144 (Friday, July 28, 2017)]
[Notices]
[Pages 35214-35216]
[FR Doc No: 2017-15900]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-2562]

Drug Products That Present Demonstrable Difficulties for
Compounding Under the Federal Food, Drug, and Cosmetic Act;
Establishment of a Public Docket

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of public docket.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is developing
a list of drug products and categories of drug products that present
demonstrable difficulties for compounding (the Difficult to Compound
List). The Agency previously solicited nominations for this list and
received approximately 71 unique nominations. FDA is establishing a new
public docket so that interested parties can nominate drug products or
categories of drug products that were not previously nominated for
inclusion on the Difficult to Compound List, resubmit previous
nominations with additional supporting information, or submit comments.

DATES: Nominations for the Difficult to Compound List and comments may
be submitted to this docket at any time.

ADDRESSES: You may submit nominations or comments as follows:

Electronic Submissions

    Submit electronic nominations or comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting nominations or comments.
Nominations or comments submitted electronically, including
attachments, to https://www.regulations.gov will be posted to the
docket unchanged. Because your nomination or comment will be made
public, you are solely responsible for ensuring that your nomination or
comment does not include any confidential information that you or a
third party may not wish to be posted, such as medical information,
your or anyone else's Social Security number, or confidential business
information, such as a manufacturing process. Please note that if you
include your name, contact information, or other information that
identifies you in the body of your nomination or comments, that
information will be posted on https://www.regulations.gov.
     If you want to submit a nomination or comment with
confidential information that you do not wish to be made available to
the public, submit the nomination or comment as a written/paper
submission and in the manner detailed (see ``Written/Paper
Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper nominations or comments submitted to the
Division of Dockets Management, FDA will post your nomination or
comment, as well as any attachments, except for information submitted,
marked and identified, as confidential, if submitted as detailed in
``Instructions.''
    Instructions: All submissions received must include the Docket No.
[Docket No. FDA-2017-N-2562] for ``Drug Products That Present
Demonstrable Difficulties for Compounding Under Sections 503A and 503B
of the Federal Food, Drug, and Cosmetic Act; Establishment of a Public
Docket.'' Received nominations and comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a nomination or
comment with confidential information that you do not wish to be made
publicly available, submit your nomination or comments only as a
written/paper submission. You should submit two copies total. One copy
will include the information you claim to be confidential with a
heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL
INFORMATION.'' The Agency will review this copy, including the claimed
confidential information, in its consideration of nominations or
comments. The second copy, which will have the claimed confidential
information redacted/blacked out, will be available for public viewing
and posted on https://www.regulations.gov. Submit both copies to the
Division of Dockets Management. If you do not wish your name and
contact information to be made publicly available, you can provide this
information on the cover sheet and not in the body of your nomination
or comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper nominations and comments received, go
to https://www.regulations.gov and insert the docket number, found in
brackets in the heading of this document, into the ``Search'' box and
follow the prompts and/or go to the Division of Dockets Management,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Pawanprit Singh, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 5206, Silver Spring, MD 20993-0002, 240-
402-8866.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 353a) describes the conditions under which a human drug
product compounded for an identified individual patient based on a
prescription qualifies for exemption from three sections of the FD&C
Act: (1) Section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) (concerning
current good manufacturing practice for drugs); (2) section 502(f)(1)
(21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate
directions for use); and (3) section 505 (21 U.S.C. 355) (concerning
the approval of human drug products under new drug applications or
abbreviated new drug applications). One of the conditions for these
exemptions is that the compounded drug product is not ``a drug product
identified by the Secretary by regulation as a drug product that
presents demonstrable difficulties for compounding that reasonably
demonstrate an adverse effect on the safety or effectiveness of that
drug product'' (section 503A(b)(3)(A) of the FD&C Act). Section
503A(c)(1) of the FD&C Act requires that, before issuing regulations to
implement section 503A(b)(3)(A) of the FD&C Act, an advisory committee
on compounding be convened and consulted ``unless the Secretary
determines that the issuance of such

regulations before consultation is necessary to protect the public
health.''
    Section 503B of the FD&C Act (21 U.S.C. 353b) describes the
conditions that must be met for human drugs compounded by or under the
direct supervision of a licensed pharmacist in an outsourcing facility
to qualify for exemptions from three sections of the FD&C Act: (1)
Section 502(f)(1) (21 U.S.C. 352(f)(1)); (2) section 505 (21 U.S.C.
355); and section 582 (21 U.S.C. 360eee-1) (concerning drug supply
chain security requirements). Section 503B does not provide an
exemption from section 501(a)(2)(B).
    One of the conditions in section 503B that must be satisfied for a
compounded drug to qualify for the exemptions in that section is that
the drug either (1) is not identified (directly or as part of a
category of drugs) on a list published by the Secretary, of drugs or
categories of drugs that present demonstrable difficulties for
compounding that are reasonably likely to lead to an adverse effect on
the safety or effectiveness of the drug or category of drugs, taking
into account the risks and benefits to patients, or (2) is compounded
in accordance with all applicable conditions identified on the list as
conditions that are necessary to prevent the drug or category of drugs
from presenting such demonstrable difficulties (see section
503B(a)(6)(A) and (a)(6)(B) of the FD&C Act). Section 503B(c)(2) of the
FD&C Act requires that before issuing regulations to implement section
503B(a)(6) of the FD&C Act, an advisory committee on compounding be
convened and consulted.
    At a meeting on July 13 and 14, 2000, an advisory committee on
compounding (specifically, the Pharmacy Compounding Advisory Committee
(PCAC)) discussed and provided FDA with advice about the Agency's
efforts to develop a list of drugs that present demonstrable
difficulties for compounding under section 503A of the FD&C Act. FDA
published a notice of that meeting in the Federal Register on June 29,
2000 (65 FR 40104). In the Federal Register of December 4, 2013 (78 FR
72840), FDA invited all interested persons to nominate drug products or
categories of drug products for inclusion on the Difficult to Compound
List. Nominators were asked to include the name of the drug product or
category of drug products being nominated, as well as the reason the
drug product or category of drug products should be included on the
list, taking into account the risks and benefits to patients. The
notice also included a list of factors that may be relevant to
determining whether or not a drug product or category of drug products
should or should not be included on the Difficult to Compound List.
Approximately 71 unique drug products or categories of drug products
were nominated for this list.
    On June 18, 2015, the PCAC reviewed and discussed FDA's proposed
criteria for evaluating whether drug products or categories of drug
products are demonstrably difficult to compound under sections 503A and
503B of the FD&C Act. After considering the PCAC's discussion, FDA
refined the criteria and presented the changes to the PCAC on March 9,
2016. The six criteria presented to the PCAC for evaluating whether a
drug product or category of drug products is demonstrably difficult to
compound are the following: (1) The complexity of the formulation; (2)
the complexity of the drug delivery mechanism; (3) the complexity of
the dosage form; (4) the complexity of achieving bioavailability; (5)
the complexity of the compounding process; and (6) the complexity of
physicochemical or analytical testing. Additional information regarding
these criteria can be found in the briefing package for the March 2016
PCAC meeting. See http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PharmacyCompoundingAdvisoryCommittee/UCM486146.pdf.

II. Establishment of a Public Docket

    FDA is establishing a public docket so that interested parties can
nominate drug products or categories of drug products for inclusion on
the Difficult to Compound List, resubmit previous nominations with
additional supporting information, or submit comments.
    Nominations should include the following two items for each drug
product or category of drug products nominated, and any other relevant
additional information available:
     The name of the drug product or drug product category;
     The reason the drug product or drug product category
should be included on the list, taking into account any risks and
benefits to patients.
    To facilitate FDA's review, nominations may include responses to
the following six questions, which are related to the criteria FDA
presented to the PCAC for evaluating whether drug products and
categories of drug products are difficult to compound under sections
503A and 503B of the FD&C Act:
    1. Does the drug product or category of drug products have a
complex formulation that presents a demonstrable difficulty for
compounding that is reasonably likely to lead to an adverse effect on
the safety or effectiveness of the drug product?
    2. Does the drug product or category of drug products have a
complex drug delivery mechanism that presents a demonstrable difficulty
for compounding that is reasonably likely to lead to an adverse effect
on the safety or effectiveness of the drug product?
    3. Does the drug product or category of drug products involve a
complex dosage form that presents a demonstrable difficulty for
compounding that is reasonably likely to lead to an adverse effect on
the safety or effectiveness of the drug product?
    4. Does the drug product or category of drug products involve
complexities in achieving and/or assessing bioavailability that present
a demonstrable difficulty for compounding that is reasonably likely to
lead to an adverse effect on the safety or effectiveness of the drug
product?
    5. Does compounding the drug product or category of drug products
involve a complex compounding process that presents a demonstrable
difficulty for compounding that is reasonably likely to lead to an
adverse effect on the safety or effectiveness of the drug product?
    6. Does compounding the drug product or category of drug products
necessitate complex physicochemical or analytical testing that presents
a demonstrable difficulty for compounding that is reasonably likely to
lead to an adverse effect on the safety or effectiveness of the drug
product?
    It is not necessary for a previously nominated drug product or
category of drug products to be renominated to this docket. Previously
nominated drug products or categories of drug products may be
renominated to this docket if the nominator wants to provide additional
supporting information, e.g., information specific to the six questions
listed above related to FDA's proposed evaluation criteria. Interested
parties can also submit comments on nominated drug products or
categories of drug products, or on this document, via this docket.
    Previous nominations to the Difficult to Compound List or comments
submitted in response to the December 4, 2013 Federal Register notice
can be viewed on https://www.regulations.gov under docket number FDA-
2013-N-1523, or by going to the Division of Dockets Management between
9 a.m. and 4 p.m., Monday through Friday.

    Dated: July 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-15900 Filed 7-27-17; 8:45 am]
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[Federal Register: April 9, 2008 (Volume 73, Number 69)]
[Notices]
[Page 19205]
[DOCID:fr09ap08-36]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL08-50-000]

Louisiana Public Service Commission: Complainant, v. System
Energy Resources, Inc., and Entergy Services, Inc.: Respondents; Notice
of Complaint

April 2, 2008.
    Take notice that on March 31, 2008, the Louisiana Public Service
Commission filed a formal complaint against System Energy Resources,
Inc. (SERI), and Entergy Services, Inc., pursuant to section 206 of the
Federal Power Act, 16 U.S.C. 824e and 18 CFR 386.206, alleging that
depreciation and decommissioning expenses should be calculated for the
Grand Gulf Nuclear Unit and the Unit Power Sales Agreement using the
current estimated useful life of that unit and that the return on
equity allowed to SERI under the Unit Power Sales Agreement should be
lowered.
    The Louisiana Public Service Commission certifies that copies of
the complaint were served on the contacts for System Energy Resources,
Inc., and Entergy Services, Inc. as listed on the Commission's list of
Corporate Officials.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 pm Eastern Time on April 21, 2008.

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-7420 Filed 4-8-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 53 (Monday, March 22, 2021)]
[Rules and Regulations]
[Pages 15101-15104]
[FR Doc No: 2021-05361]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R06-OAR-2015-0189; FRL-10019-83-Region 6]

Air Plan Approval; Arkansas; Regional Haze and Interstate
Visibility Transport Federal Implementation Plan; Withdrawal of Federal
Implementation Plan Provisions for the Domtar Ashdown Mill

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking final
action to withdraw the remaining portion of a Federal Implementation
Plan (FIP) for Arkansas that was published in the Federal Register on
September 27, 2016, which addressed certain regional haze obligations
for the first implementation period for the Domtar Ashdown Mill.
Specifically, this remaining portion of the FIP we are withdrawing
contains best available retrofit technology (BART) requirements for
sulfur dioxide (SO2) and nitrogen oxide (NOX) for
Domtar Ashdown Mill Power Boiler No. 1; and SO2,
NOX, and particulate matter (PM) BART requirements for Power
Boiler No. 2. These portions of the FIP are being replaced by a
revision to the Arkansas State Implementation Plan (SIP) containing
SO2, NOX, and PM10 BART alternative
emission limitations that we are taking final action to approve in a
separate rulemaking that is also being published in this issue of the
Federal Register.

DATES: This final rule will be effective April 21, 2021.

ADDRESSES: The EPA has established a docket for this action under
Docket No. EPA-R06-OAR-2015-0189. All documents in the docket are
listed at the http://www.regulations.gov website. Although listed in
the index, some information is not publicly available, e.g.,
confidential business information or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, is not placed on the internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through http://www.regulations.gov or
in hard copy at the EPA Region 6, 1201 Elm Street, Suite 500, Dallas,
Texas 75270-2102.

FOR FURTHER INFORMATION CONTACT: James E. Grady, Air and Radiation
Division, Environmental Protection

Agency, Region 6, 1201 Elm Street, Suite 500, Dallas, Texas 75270,
telephone<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document ``we,'' ``us,'' or
``our'' mean ``the EPA.''

Table of Contents

I. Background
II. Final Action
III. Responses to Comments
IV. Statutory and Executive Order Reviews

I. Background

    Arkansas submitted a SIP revision on September 9, 2008, to address
the requirements of the first regional haze implementation period. On
August 3, 2010, Arkansas submitted a SIP revision with mostly non-
substantive revisions to Arkansas Pollution Control and Ecology
Commission (APCEC) Regulation 19, Chapter 15.\1\ On September 27, 2011,
the State submitted supplemental information to clarify several aspects
of the September 9, 2008 submittal. Hereafter we refer to these
regional haze submittals collectively as the ``2008 Arkansas Regional
Haze SIP.'' On March 12, 2012, we partially approved and partially
disapproved the 2008 Arkansas Regional Haze SIP.\2\ On September 27,
2016, in accordance with section 110(c)(1) of the CAA, we promulgated a
FIP (the Arkansas Regional Haze FIP) addressing the disapproved
portions of the 2008 Arkansas Regional Haze SIP.\3\ Among other things,
the FIP established SO2, nitrogen oxide (NOX),
and PM emission limits under the BART requirements for nine units at
six facilities: Arkansas Electric Cooperative Corporation (AECC) Bailey
Plant Unit 1; AECC McClellan Plant Unit 1; the American Electric Power/
Southwestern Electric Power Company (AEP/SWEPCO) Flint Creek Plant
Boiler No. 1; Entergy Arkansas, Inc. (Entergy) Lake Catherine Plant
Unit 4; Entergy White Bluff Plant Units 1 and 2; Entergy White Bluff
Auxiliary Boiler; and the Domtar Ashdown Mill Power Boilers No. 1 and
2. The FIP also established SO2 and NOX emission
limits under the reasonable progress requirements for Entergy
Independence Units 1 and 2.
---------------------------------------------------------------------------

    \1\ The September 9, 2008 SIP submittal included APCEC
Regulation 19, Chapter 15, which is the state regulation that
identified the BART-eligible and subject-to-BART sources in Arkansas
and established BART emission limits for subject-to-BART sources.
The August 3, 2010 SIP revision did not revise Arkansas' list of
BART-eligible and subject-to-BART sources or revise any of the BART
requirements for affected sources. Instead, it included mostly non-
substantive revisions to the state regulation.
    \2\ 77 FR 14604.
    \3\ 81 FR 66332; see also 81 FR 68319 (October 4, 2016)
(correction).
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    Following the issuance of the Arkansas Regional Haze FIP, the State
of Arkansas and several industry parties filed petitions for
reconsideration and a motion for an administrative stay of the final
rule.\4\ On April 14, 2017, we announced our decision to reconsider
several elements of the FIP, as follows: Appropriate compliance dates
for the NOX emission limits for Flint Creek Boiler No. 1,
White Bluff Units 1 and 2, and Independence Units 1 and 2; the low-load
NOX emission limits applicable to White Bluff Units 1 and 2
and Independence Units 1 and 2 during periods of operation at less than
fifty percent of the units' maximum heat input rating; the
SO2 emission limits for White Bluff Units 1 and 2; and the
compliance dates for the SO2 emission limits for
Independence Units 1 and 2.\5\
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    \4\ See the docket associated with this proposed rulemaking for
a copy of the petitions for reconsideration and administrative stay
submitted by the State of Arkansas; Entergy Arkansas Inc., Entergy
Mississippi Inc., and Entergy Power LLC (collectively ``Entergy'');
AECC; and the Energy and Environmental Alliance of Arkansas (EEAA).
    \5\ Letter from E. Scott Pruitt, Administrator, EPA, to Nicholas
Jacob Bronni and Jamie Leigh Ewing, Arkansas Attorney General's
Office (April 14, 2017). A copy of this letter is included in the
docket no. EPA-R06-OAR-2015-0189-0240 at https://www.regulations.gov.
---------------------------------------------------------------------------

    EPA also published a document in the Federal Register on April 25,
2017, which administratively stayed the effectiveness of the
NOX compliance dates in the FIP for the Flint Creek, White
Bluff, and Independence units, as well as the compliance dates for the
SO2 emission limits for the White Bluff and Independence
units for a period of ninety days.\6\ On July 13, 2017, the EPA
published a document proposing to extend the NOX compliance
dates for Flint Creek Boiler No. 1, White Bluff Units 1 and 2, and
Independence Units 1 and 2, by 21 months, to January 27, 2020.\7\
However, EPA did not take final action on the July 13, 2017 proposed
rule because on July 12, 2017, Arkansas submitted a proposed SIP
revision with a request for parallel processing (Arkansas Regional Haze
NOX SIP revision or Arkansas NOX SIP revision).
The State's proposed revision addressed the NOX BART
requirements for Bailey Unit 1, McClellan Unit 1, Flint Creek Boiler
No. 1, Lake Catherine Unit 4, White Bluff Units 1 and 2, and White
Bluff Auxiliary Boiler, as well as the reasonable progress requirements
with respect to NOX. We processed this proposed SIP revision
in parallel with the state's SIP approval process and, in a proposed
rule published in the Federal Register on September 11, 2017, we
proposed approval of the Arkansas Regional Haze NOX SIP
revision and withdrawal of the corresponding parts of the Arkansas
Regional Haze FIP.\8\ On October 31, 2017, we received Arkansas' final
Regional Haze NOX SIP revision addressing NOX
BART for EGUs and the reasonable progress requirements with respect to
NOX for the first implementation period. On February 12,
2018, we finalized our approval of the Arkansas Regional Haze
NOX SIP revision and our withdrawal of the corresponding
parts of the FIP.\9\
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    \6\ 82 FR 18994.
    \7\ 82 FR 32284.
    \8\ 82 FR 42627.
    \9\ 83 FR 5927 and 83 FR 5915 (February 12, 2018).
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    On August 8, 2018, Arkansas submitted another SIP revision
(Arkansas Regional Haze SO2 and PM SIP revision or Phase II
SIP revision) addressing all remaining disapproved parts of the 2008
Regional Haze SIP, with the exception of the BART and associated long-
term strategy requirements for the Domtar Ashdown Mill Power Boilers
No. 1 and 2. In a proposed rule published in the Federal Register on
November 30, 2018, we proposed approval of a portion of the SIP
revision and we also proposed to withdraw the parts of the FIP
corresponding to our proposed approvals.\10\ The Phase II SIP revision
included a discussion of Arkansas' interstate visibility transport
requirements, and we stated in our proposed rule that we intended to
propose action on this portion of the SIP revision in a future proposed
rulemaking. On September 27, 2019, we took final action to approve a
portion of the Arkansas Regional Haze SO2 and PM SIP
revision and to withdraw the corresponding parts of the FIP.\11\
---------------------------------------------------------------------------

    \10\ 83 FR 62204 (November 30, 2018).
    \11\ 84 FR 51033 and 84 FR 51056 (Sept. 27, 2019).
---------------------------------------------------------------------------

    On August 13, 2019, Arkansas submitted the Arkansas Regional Haze
Phase III SIP (Phase III SIP revision). This SIP revision contains a
BART alternative to address BART and the associated long-term strategy
requirements for two subject-to-BART sources (Power Boilers No. 1 and
2) at the Domtar Ashdown Mill located in Ashdown, Arkansas. The BART
alternative addresses SO2, PM, and NOX BART for
Power Boilers No. 1 and 2. On March 16, 2020, we proposed to approve
the Phase III SIP revision.\12\ Our proposed rule included proposed
approval of the BART alternative for SO2, PM, and
NOX at Power Boilers No. 1 and 2 and elements that relate to
the BART requirements at this facility;

proposed approval of Arkansas' request to withdraw from the approved
SIP the previously approved PM10 BART limit for Power Boiler
No. 1; and proposed withdrawal of the remaining portion of the Arkansas
FIP, which consists of provisions addressing the regional haze
requirements for the Domtar Ashdown Mill. The EPA also proposed to
approve the portions of the August 8, 2018 Arkansas Regional Haze Phase
II SIP revision and the October 4, 2019 Arkansas 2015 Ozone
(O3) NAAQS Interstate Transport SIP revision addressing the
visibility transport provisions required under CAA section
110(a)(2)(D)(i)(II) for the following NAAQS: The 2006 24-hour
PM2.5 NAAQS; the 2012 annual PM2.5 NAAQS; the
2008 and 2015 eight-hour O3 NAAQS; the 2010 one-hour
NO2 NAAQS; and the 2010 one-hour SO2 NAAQS. In a
final action being published separately in this issue of the Federal
Register, we are taking final action to approve the Arkansas Regional
Phase III SIP revision and the visibility transport portions of the
Arkansas Regional Haze Phase II SIP revision and the Arkansas 2015
O3 NAAQS Interstate Transport SIP revision.
---------------------------------------------------------------------------

    \12\ 85 FR 14847 (March 16, 2020).
---------------------------------------------------------------------------

    The background for this final rule and the separate final action
also being published in this issue of the Federal Register that
approves the Arkansas Regional Haze Phase III SIP revision and portions
of the Arkansas Regional Haze Phase II SIP revision and the Arkansas
2015 O3 NAAQS Interstate Transport SIP revision is also
discussed in detail in our March 16, 2020 proposed approval.\13\ The
comment period was open for thirty days and closed on April 15, 2020.
We received a total of two sets of public comments concerning our
proposed action. The comments are included in the publicly posted
docket associated with the rulemaking (EPA-R06-OAR-2015-0189),
available at https://www.regulations.gov.
---------------------------------------------------------------------------

    \13\ 85 FR 14847.
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II. Final Action

    We are withdrawing the remaining portion of the Arkansas Regional
Haze FIP that we promulgated on September 27, 2016, found at 40 CFR
52.173(c). Specifically, we are withdrawing provisions addressing
applicability and definitions of the FIP; SO2 and
NOX emission limits for Power Boiler No. 1; SO2,
NOX, and PM emission limits for Power Boiler No. 2; BART
compliance dates; compliance determination requirements and reporting
and recordkeeping requirements associated with the BART emission
limits; and provisions addressing equipment operations and enforcement.
We are removing these SO2, NOX, and PM emission
limitations and associated requirements for Power Boilers No. 1 and 2
found at 40 CFR 52.173(c), and as of the effective date of this final
rule these requirements will no longer apply to these units. Since we
are withdrawing the text from paragraph (c) under 40 CFR 52.173, we are
also reserving paragraph (c) so as to not disturb the numbering of
existing paragraphs (d) through (g) under 40 CFR 52.173.
    As explained in our March 16, 2020 proposal,\14\ this action is
based on our separate action being published in this issue of the
Federal Register approving the Arkansas Regional Haze Phase III SIP
revision submitted to us on August 13, 2019. In that separate action,
EPA is making the determination that the Arkansas Regional Haze Phase
III SIP revision is approvable because the plan's provisions meet the
applicable requirements of the CAA and EPA implementing regulations.
EPA is finalizing this action under section 110 and part C of the Act.
---------------------------------------------------------------------------

    \14\ 85 FR 14847.
---------------------------------------------------------------------------

III. Response to Comments

    We received two comment letters concerning our proposed action,
which included our proposed approval of the Phase III SIP revision,
proposed approval of the visibility transport portions of the Arkansas
Regional Haze Phase II SIP revision and the Arkansas 2015 O3
NAAQS Interstate Transport SIP revision, and proposed withdrawal of the
remaining FIP provisions. EPA did not receive any comments specifically
addressing our proposed withdrawal of the remaining FIP provisions;
rather, the comments addressed EPA's proposed approval of the SIP
provisions that would replace the FIP. Therefore, we have responded to
all relevant comments in response to our proposed action in the
separate, final notice being published in this issue of the Federal
Register that approves the Arkansas Regional Haze Phase III SIP
revision.\15\
---------------------------------------------------------------------------

    \15\ Please see Docket No. EPA-R06-OAR-2015-0189 at https://www.regulations.gov.
---------------------------------------------------------------------------

IV. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders
can be found at http://www2.epa.gov/lawsregulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review 13563

    This action is exempt from review by the Office of Management and
Budget (OMB) because it will withdraw a FIP containing source-specific
SO2, NOX, and PM emission limits for two
individually identified units at one facility in Arkansas and is
therefore not a rule of general applicability and not a significant
regulatory action.

B. Paperwork Reduction Act

    This action does not impose an information collection burden under
the provisions of the PRA. Burden is defined at 5 CFR 1320.3(b). This
final rule withdraws a FIP containing source-specific SO2,
NOX, and PM emission limits for two individually identified
units at one facility in Arkansas.

C. Regulatory Flexibility Act

    I certify that this final action will not have a significant
economic impact on a substantial number of small entities under the
RFA. This final action will not impose any requirements on small
entities. This final action withdraws a FIP containing source-specific
SO2, NOX, and PM emission limits that apply to
two individually identified units at one facility in Arkansas.

D. Unfunded Mandates Reform Act

    This action does not contain any unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. This action does not impose additional requirements
beyond those imposed by state law. Accordingly, no additional costs to
State, local, or tribal governments, or to the private sector, will
result from this action.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have
substantial direct effects on the states, on the relationship between
the national government and the states, or on the distribution of power
and responsibilities among the various levels of government.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications, as specified in
Executive Order 13175, because the FIP we are withdrawing does not
apply on any Indian reservation land or in any other area where the EPA
or an Indian tribe has demonstrated that a tribe has

jurisdiction, and will not impose substantial direct costs on tribal
governments or preempt tribal law. This final action withdraws a FIP
that applies to two individually identified units at one facility in
Arkansas. There are no Indian reservation lands in Arkansas. Thus,
Executive Order 13175 does not apply to this action.

G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks \16\ applies to any rule that: (1) Is
determined to be economically significant as defined under Executive
Order 12866; and (2) concerns an environmental health or safety risk
that we have reason to believe may have a disproportionate effect on
children. EPA interprets E.O. 13045 as applying only to those
regulatory actions that concern health or safety risks, such that the
analysis required under Section 5-501 of the E.O. has the potential to
influence the regulation. This action is not subject to Executive Order
13045 because it is not economically significant as defined in
Executive Order 12866, and because the EPA does not believe the
environmental health or safety risks addressed by this action present a
disproportionate risk to children. This action is not subject to E.O.
13045 because it implements specific standards established by Congress
in statutes.
---------------------------------------------------------------------------

    \16\ 62 FR 19885 (Apr. 23, 1997).
---------------------------------------------------------------------------

H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use

    This action is not subject to Executive Order 13211 (66 FR 28355
(May 22, 2001)), because it is not a significant regulatory action
under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

    This rulemaking does not involve technical standards.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    The EPA believes that this action does not have disproportionately
high and adverse human health or environmental effects on minority
populations, low-income populations and/or indigenous peoples, as
specified in Executive Order 12898 (59 FR 7629, February 16, 1994).

K. Determination Under Section 307(d)

    Pursuant to CAA section 307(d)(1)(B), this action is subject to the
requirements of CAA section 307(d), as it revises a FIP under CAA
section 110(c).

L. Congressional Review Act (CRA)

    This rule is exempt from the CRA because it is a rule of particular
applicably. EPA is not required to submit a rule report regarding this
action under section 801 because this is a rule of particular
applicability that only affects one individually identified facility in
Arkansas.

M. Petitions for Judicial Review

    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by May 21, 2021. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this rule for the purposes of judicial
review nor does it extend the time within which a petition for judicial
review may be filed, and shall not postpone the effectiveness of such
rule or action. This action may not be challenged later in proceedings
to enforce its requirements (see section 307(b)(2)).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Best available
retrofit technology, Incorporation by reference, Intergovernmental
relations, Nitrogen dioxide, Ozone, Particulate Matter, Regional haze,
Reporting and recordkeeping requirements, Sulfur Dioxide, Visibility.

Jane Nishida,
Acting Administrator.
    Title 40, chapter I, of the Code of Federal Regulations is amended
as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart E--Arkansas

Sec.  52. 173  [Amended]

    2. In Sec.  52.173, remove and reserve paragraph (c).
[FR Doc. 2021-05361 Filed 3-19-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 218 (Friday, November 9, 2012)]
[Notices]
[Page 67408]
[FR Doc No: 2012-27529]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold a Closed Meeting on Friday, November
9, 2012 at 9:00 a.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meeting.
Certain staff members who have an interest in the matters also may be
present.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(5), (7), 9(B) and (10) and 17 CFR 200.402(a)(5),
(7), 9(ii) and (10), permit consideration of the scheduled matters at
the Closed Meeting.
    Commissioner Aguilar, as duty officer, voted to consider the items
listed for the Closed Meeting in a closed session and determined that
no earlier notice thereof was possible.
    The subject matter of the Closed Meeting scheduled for Thursday,
November 8, 2012 will be:

    Institution and settlement of injunctive actions;
    Institution and settlement of administrative proceedings;

    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact: The Office of the
Secretary at<PHONE_NUMBER>.

    Dated: November 7, 2012.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2012-27529 Filed 11-7-12; 4:15 pm]
BILLING CODE 8011-01-P