Page 1 of 36 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, DC 20460 OFFICE OF PREVENTION, PESTICIDES, AND TOXIC SUBSTANCES March 23, 2006 MEMORANDUM SUBJECT: Occupational and Residential Exposure Assessment of Alkylbenzene Sulfonates for the Reregistration Eligibility Decision Document ( RED).

TO: Heather Garvie, Chemical Review Manager, Reregistration Team 36 Regulatory Management Branch II Antimicrobials Division ( 7510C)

And Deborah Smegal, Risk Assessor Reregistration Branch I Health Effects Division ( 7509C)

FROM: Talia Milano, Chemist, Team II Risk Assessment and Science Support Branch ( RASSB) Antimicrobials Division ( 7510C)

THRU: Norm Cook, Branch Chief Risk Assessment and Science Support Branch ( RASSB) Antimicrobials Division ( 7510C)

DP Barcode: 327732 Case No.: 4006 Chemical Name ( s) CAS # 1 PC CODE1 Sodium dodecylbenzene sulfonate 25155 30 0 079010 Benzenesulfonic acid, C10 16 alkyl derivatives 68584 22 5 190116 Dodecylbenzene sulfonic acid 27176 87 0 098002 1: The CAS # and PC Codes listed reflect the current numbering system. However, Dodecylbenzene sulfonic acid is not a pure chemical, and is considered part of the mixture of Benzenesulfonic acid. A discussion of this discrepancy can be found in the text of the chapter along in the Preliminary Risk Assessment. Page 2 of 36 OCCUPATIONAL AND RESIDENTIAL EXPOSURE ASSESSMENT OF ALKYLBENZENE SULFONATES IN SUPPORT OF THE REREGISTRATION ELIGIBILITY DECISION DOCUMENT ( RED)

REREGISTRATION CASE 4006 3/ 23/ 06 Antimicrobials Division Office of Pesticide Programs U. S. Environmental Protection Agency 1200 Pennsylvania Avenue, NW Washington, DC 20460 Page 3 of 36 TABLE OF CONTENTS:

EXECUTIVE SUMMARY................................................................................................ 4 1.0 INTRODUCTION....................................................................................................... 6 1.1 Purpose.............................................................................................................. 6 1.2 Criteria for Conducting Exposure Assessments................................................ 7 1.3 Chemical Identification..................................................................................... 7 1.4 Physical/ Chemical Properties............................................................................ 8 2.0 USE INFORMATION............................................................................................... 8 2.1 Formulation Types and Percent Active Ingredient............................................. 8 2.2 Summary of Use Pattern and Formulations....................................................... 8 3.0 SUMMARY OF TOXICITY DATA.......................................................................... 10 3.1 Acute Toxicity..................................................................................................... 10 3.2 Summary of Toxicity Endpoints.......................................................................... 10 3.3 FQPA Considerations.......................................................................................... 11 4.0 RESIDENTIAL EXPOSURE ASSESSMENT.......................................................... 13 4.1 Residential Exposure...................................................................................... 13 5.0 OCCUPATIONAL EXPOSURE ASSESSMENT................................................. 14 5.1 Occupational Handler Exposures.................................................................... 20 5.2 Occupational Post application Exposures....................................................... 27 5.3 Data Limitations/ Uncertainties........................................................................ 27 6.0 REFERENCES........................................................................................................... .. 29 APPENDIX A ....................................................................................................................... 30 APPENDIX B ........................................................................................................................ 32 Page 4 of 36 EXECUTIVE SUMMARY This document is the Occupational and Residential Exposure Assessment for the Reregistration Eligibility Decision Document ( RED) for alkylbenzene sulfonates. The currently listed active ingredients that are included under this decision are sodium dodecylbenzene sulfonate ( CAS # 25155 30 0), dodecylbenzene sulfonic acid ( CAS # 27176 87 0), and benzenesulfonic acid, C10 C16 alkyl derivatives ( CAS # 68584 22 5). To date, dodecylbenzene sulfonic acid has been listed separately from benzenesulfonic acid, C10 C16 alkyl derivatives, and identified by the CAS # 27176 87 0 on numerous labels and in different databases. Dodecylbenzene sulfonic acid is not considered to be a pure compound, and is included in the mixture of benzenesulfonic acid, C10 16 alkyl derivatives. For future references of this chapter, any conclusions that are made specifically about benzenesulfonic acid, C10 C16 alkyl derivatives will be representative of dodecylbenzene sulfonic acid. For this specific chapter, the chemicals are referred to as they are identified in current databases.

At this time alkylbenzene sulfonates are active ingredients in twenty three registered end use products such as cleaners and sanitizers that are designated for used in agricultural, food handling and commercial/ institutional/ industrial settings ( Use Site Categories I, II, and III respectively). These products have not been identified to have any residential use sites, and therefore a residential assessment was not conducted at this time. In addition, a majority of the currently registered labels require the use of gloves, protective clothing, goggles, and a face shield. Examples of registered uses for alkylbenzene sulfonates include, but are not limited to: application to indoor hard surfaces ( e. g. urinals, shower stalls, toilet bowls, etc.), food dispensing equipment ( e. g. pre mix and post mix vending machines), food contact surfaces ( glasses, dishes, silverware, countertops, etc.), agricultural tools, and fruits and vegetables ( post harvest). This assessment contains the non dietary occupational exposure assessment for alkylbenzene sulfonates when they are listed as active ingredients. The dietary assessment as well as an inert assessment for the uses of the sulfonates will be assessed separately in supporting documents of this RED. The percentage of alkylbenzene sulfonates in various products can range from 0.036% to 25.6%. Products containing alkylbenzene sulfonates are formulated as soluble concentrates, flowable concentrates, ready to use solutions, or water soluble packaging.

The durations and routes of exposure that was evaluated in this assessment include short term ( ST) and intermediate term ( IT) inhalation exposures. There is no evidence of systemic toxicity via the dermal route, and this is why a dermal endpoint was not provided, and thus, no dermal assessment has been conducted at this time. Alkylbenzene sulfonates are considered to be dermal irritants in formulations that have listed amounts of active ingredient generally greater than 20%. The following excerpt is reiterated from the toxicological endpoint Table 4.

Quantification of dermal risk is not required since: 1) the alkylbenzene sulfonates are surfactants that are dermal irritants at concentrations generally greater than 20% solution ( WHO 1996). Thus, dermal exposure would be self limiting to preclude dermal irritation. Most pesticide formulations have less than 5% alkylbenzene sulfonates as an inert ingredient, with the vast majority of household products containing approximately 2%. Additionally, the requirement of the dermal toxicity studies with the end use product will determine whether personal protective clothing would be necessary to protect against irritation during product Page 5 of 36 use; 2) no systemic toxicity was seen following repeated dermal applications to rabbits at 200 mg/ kg/ day ( with an end use product); 3) no developmental toxicity concerns were seen following repeated dermal applications to pregnant mice, rats or rabbits ( developmental effects were seen either in the presence of maternal toxicity or at doses higher than those that caused maternal toxicity); and 4) there is no residential exposure to alkylbenzene sulfonates as an active ingredient, however, residential exposure from its use as an inert ingredient in pesticide formulations is expected to be of an intermittent nature ( i. e, no continuous, constant contact, multi day exposure) from household products.

For the dose calculations, the default inhalation absorption factor was 100%. In addition, the toxicological report is important to review for a more detailed explanation of the endpoints that were calculated.

The use sites and application rates were examined for all of the labels that included the one of the three sulfonates as the active ingredient. From this examination, the representative scenarios were chosen. However, even though the toxicological endpoints selected for all of the chemicals represented by this case number are the same, the labels that listed sodium dodecylbenzene sulfonate still had be assessed individually if they were not chosen to be the representative label. The reason for this is because for each label that lists sodium dodecylbenzene sulfonate as the active ingredient; there was direction for a handler to use the same product for both the cleaning and sanitizing steps via various methods. There is an expected risk to the handler that performs both cleansing and sanitizing in the same time frame, and this risk was evaluated by calculating the total MOE.

To assess the handler risks, the Agency used surrogate unit exposure data from the following proprietary Chemical Manufacturers Association ( CMA) antimicrobial exposure study and the Pesticide Handlers Exposure Database ( PHED).

For the occupational handler inhalation risk assessment, the MOEs were greater than or equal to the target MOE of 100 for all scenarios except the following:

Handler Risk Summary for alkylbenzene sulfonates:

  ST and IT inhalation exposure from cleaning hard surfaces via circulation/ flow/ flushing in the agricultural premises and equipment category, inhalation MOE = 0.27.   ST and IT inhalation exposure from application to hard surfaces via circulation systems/ flow method in the food handling category, inhalation MOE = 0.16.   ST and IT inhalation exposure from cleaning hard surfaces via wiping in the food handling category, inhalation MOE = 93.   ST and IT inhalation exposure from application to hard surfaces via CIP ( Cleaning in Place) in the food handling premises category, inhalation MOE = 0.14.   ST and IT inhalation exposure from cleaning food dispensing equipment via circulation systems/ flow method in the food handling category, inhalation MOE = 0.16.   ST and IT Inhalation exposure from cleaning shower stalls and toilets via a liquid pour application in the commercial/ institutional premises, inhalation MOE = 13.   ST and IT inhalation exposure from cleaning shower stalls and toilets via wiping in the commercial/ institutional premises, inhalation MOE = 0.38. Page 6 of 36 Total Exposure Summary for sodium dodecylbenzene sulfonate ( results from cleaning and sanitizing with the same product in the same time frame)

  ST and IT inhalation exposure from cleaning indoor hard surfaces via wiping and then following with sanitizing via immersion/ flooding in the food handling premises category, inhalation MOE = 93.   ST and IT inhalation exposure from cleaning indoor hard surfaces via wiping and then following with sanitizing via low pressure spray in the food handling premises category, inhalation MOE = 90.   ST and IT inhalation exposure from cleaning indoor hard surfaces via sponge/ mesh/ wiping and then sanitizing via immersion/ flooding in the food handling premises category, inhalation MOE = 90.   ST and IT inhalation exposure from cleaning and sanitizing steps to be conducted through CIP ( Cleaning in Place) in the food handling premises category, inhalation MOE = < 1.

Data Limitations and Uncertainties:

There are a number of uncertainties associated with this assessment and these have been reiterated from Section 6.3.

  Surrogate inhalation unit exposure values were taken from the proprietary Chemical Manufacturers Association ( CMA) antimicrobial exposure study ( USEPA, 1999: DP Barcode D247642) or from the Pesticide Handler Exposure Database ( USEPA, 1998) ( See Appendix A for summaries of these data sources). Most of the CMA data are of poor quality; therefore, AD requests that confirmatory monitoring data be generated to support the values used in these assessments.   The quantity handled/ treated were estimated based on information from various sources, and in certain cases, no standard values were available for some scenarios. Assumptions and groupings for these scenarios were based on Agency estimates and could be further refined with input from registrants.   The quantity handled for cleaning in place systems was estimated based on the size of tunnel pasteurization systems. The labels for CIP systems indicate that small amounts of the product could be introduced into the system for cleansing whereas other labels direct for the system to be filled to its maximum capacity. This maximum capacity was not listed on the label, so this is why the value for tunnel pasteurization was used as a conservative size estimate. This can be further refined with input from the registrants. Page 7 of 36 1.0 INTRODUCTION 1.1 Purpose In this document, the Agency presents the results of its review of the potential effects of occupational exposure to the alkylbenzene sulfonates when they are listed as active ingredients in registered products. This information is for use in EPA's development of the alkylbenzene sulfonates Reregistration Eligibility Decision Document ( RED).

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

Using surrogate unit exposure data, maximum application rates from labels, and EPA estimates of daily amount handled, exposures and risks to handlers were calculated and assessed. Appendix A includes all of the equations utilized and is supplemented with some definitions. Also, in lieu of registrant submitted data, the proprietary unit exposure data that was used for this assessment are discussed in Appendix B.

In addition to the target MOEs from Section 3.2 that were used for the analysis, a series of assumptions and exposure factors served as the basis for completing the handler risk assessment. Each general assumption and factor for the occupational assessment is detailed below. Assumptions specific to the use site category are listed in each separate section of this document. The general assumptions and factors include:

  The Agency has patterned this risk assessment on a series of likely representative scenarios for each use site that are believed by the Agency to represent the vast majority of alkylbenzene sulfonate uses.   Based on the adverse effects for the endpoints, the average body weight of an adult handler of 70 kg was used to complete the non cancer risk assessment.   Exposure factors used to calculate daily exposures to handlers were based on applicable data, if available. When appropriate data were lacking, values from a scenario deemed similar were used.   The maximum application rates allowed by labels were assumed.

1.3 Chemical Identification Three chemical names are considered in this document: 1) sodium dodecylbenzene sulfonate, 2) dodecylbenzene sulfonic acid, and 3) benzenesulfonic acid, C10 C16 alkyl derivatives. Dodecylbenzene sulfonic acid is not a pure compound, and for future references will be addressed jointly with benzenesulfonic acid, C10 C16 alkyl derivatives. However, as previously stated, this document follows the current nomenclature that is found in databases, in which dodecylbenzene sulfonic acid is listed and identified separately. These chemical properties have been extracted from the " Product Chemistry Science Chapter" of this RED. Page 8 of 36 Table 1 Chemical Identification Information for Alkylbenzene Sulfonates Parameter Sodium Dodecylbenzene Sulfonate Benzene Sulfonic Acid, C10 16 alkyl derivatives Dodecylbenzene Sulfonic Acid CAS Number 25155 30 0 68584 22 5 27176 87 0 Molecular Formula C18H29O3S Na C16H26O3S C18H30O3S 1.4 Physical/ Chemical Properties Table 2 displays the physical/ chemical characteristics that have been reported for the alkylbenzene sulfonates. As previously stated, the product chemistry chapter provides a comprehensive list of the different physical/ chemical properties.

Table 2 Physical/ Chemical Properties of Alkylbenzene Sulfonates Parameter Sodium Dodecylbenzene Sulfonate Benzene Sulfonic Acid, C10 16 alkyl derivatives Dodecylbenzene Sulfonic Acid Molecular Weight 348.48 g/ mol 298.44 g/ mol 326.50 g/ mol Henry Law Constant 6.02 x 10 17 atm. m3/ mol 2.8 x 10 11 atm m3/ mol 4.8 x 10 11 atm m3/ mol Melting Point 287.6OC 167.7 O C 178 OC Boiling Point 660OC 437 OC 460 OC Water Solubility 800 mg/ L 7.1 mg/ L ( 25 O C) 0.7 mg/ L log Kow 1.96 3.80 4.78 Vapor Pressure 6.02 x 10 15 mm Hg 5.1 x 10 10 mm Hg ( 25o C) 7.9 x 10 11 mm Hg ( 25o C)

2.0 USE INFORMATION 2.1 Formulation Types and Percent Active Ingredient The twenty three EPA registered products that contain alkylbenzene sulfonates as the active ingredients ( a. i.) are formulated as soluble concentrates, flowable concentrates, readyto use solutions, and water soluble packaging. Concentrations of alkylbenzene sulfonates in these products range from 0.036% to 25.6%.

2.2 Summary of Use Pattern and Formulations Alkylbenzene sulfonates are active ingredients in numerous sanitizing and cleaning products. The Agency recognizes that the alkylbenzene sulfonates are also used extensively as inerts in several products such as formulated detergents, cleaners, and other consumer products. The inert uses will be assessed under a separate review document as a part of the RED process. The Agency determines potential exposures to handlers of the product by identifying exposure scenarios from the various application methods that are plausible, given the label uses. These scenarios are identified in Table 3, and are listed separately by each active ingredient that is currently listed on the labels and in databases. Based on a review of labels, products containing alkylbenzene sulfonates are intended for use in agricultural, food handling and commercial/ institutional/ industrial settings ( Use Site Categories I, II, and III respectively). Page 9 of 36 Examples of registered uses for alkylbenzene sulfonates include application to indoor hard surfaces ( e. g. urinals, shower stalls, toilet bowls, equipment, etc.), food dispensing equipment ( e. g. pre mix and post mix vending machines), food contact surfaces ( glasses, dishes, silverware, countertops, etc.), agricultural tools, and fruits and vegetables ( post harvest). As previously stated, the dietary assessment will also be conducted in a separate review document as a part of the RED process.

Table 3 Potential Use Scenarios Based on Product Labels for Alkylbenzene Sulfonates Use Site Category Example Use Sites Scenarios Sodium dodecylbenzene sulfonate ( CAS No. 25155 30 0)

Use Site Category II Food Handling/ Storage Establishments Premises and Equipment Dairy and food processing plants; meat and poultry plants; and other eating establishments   Application to hard surfaces and equipment through brush, low pressure spray, high pressure spray, mopping, wiping, foam, flooding, immersion, CIP.

  Application to dishes and silverware by brush, foam, wiping, low pressure spray, and immersion.

  Application to fruits and vegetables by immersion and spray.

  Application to food dispensing equipment through circulation cleaning system.

Dodecylbenzene Sulfonic Acid ( CAS No. 68584 22 5)

Use Site Category I Agricultural Premises and Equipment Dairy Farms   Application to hard surfaces and equipment through brush, low pressure spray, high pressure spray, foam, flooding, circulation/ recirculation systems, flushing, immersion, flow method, CIP. Use Site Category II Food Handling/ Storage Establishments Premises and Equipment Dairy and food processing plants; food service industry; carbonated beverage industry; meat and poultry plants; food service areas of public eating places, schools, and bars   Application to hard surfaces and equipment through brush, low pressure spray, high pressure sprayer, foam, pump or trigger sprayer, circulation/ recirculation systems, flushing, flooding, immersion, mopping, wiping, CIP, flow method.

  Application to glasses, dishes, stoves, countertops, and silverware by brush, foam, wiping, low pressure spray, trigger sprayer, and immersion.

  Application to fruits and vegetables by immersion.

  Application to food dispensing equipment through circulation cleaning system. Use Site Category III Commercial/ Institutional and Industrial Premises and Equipment Toilet bowls, urinals, shower stalls; institutional premises1,2   Application to hard surfaces through cloth, sponge, bowl mop, liquid pour, or immersion.

Benzenesulfonic Acid, C10 C16 alkyl derivatives ( CAS No. 68584 22 5)

Use Site Category I Agricultural Premises and Equipment Dairy farms   Application to hard surfaces through foam, brush, immersion, low pressure spray. Page 10 of 36 Table 3 Potential Use Scenarios Based on Product Labels for Alkylbenzene Sulfonates Use Site Category Example Use Sites Scenarios Use Site Category II Food Handling/ Storage Establishments Premises and Equipment Dairy and food processing plants; restaurants; beverage plants; meat and poultry plants   Application to hard surfaces and equipment through brush, immersion, low pressure spray, foam, and CIP.

  Application to glasses, stoves, countertops, dishes and silverware by brush, foam, wiping, low pressure spray, trigger sprayer, and immersion.

  Application to food dispensing equipment through circulation cleaning system. Use Site Category III Commercial/ Institutional and Industrial Premises and Equipment Institutional establishments2   Application to hard surfaces and equipment through brush, immersion, low pressure spray, and foam.

1: These bathroom sites, on label Reg. # 3635 279, are assumed to be in industrial, institutional, and commercial premises, not residential. A complete discussion of the label terminology leading to the Agency's decision not to assess residential exposure is included in Section 4.1, Residential Exposure. 2: Institutional premises can include daycare centers in which there is potential exposure to children. However, hard surfaces that are treated with this product do not include floors. For example, Reg. # 74210 1 lists, " plates, utensils, cups, [ and] glasses," as the use sites for institutional premises. As mentioned in footnote number 1, a more elaborate discussion on label terminology leading to the conclusion that a residential exposure assessment is not warranted ( handler or post application) is included in Section 4.1.

From Table 3, the Agency selected representative exposure scenarios to assess for the occupational inhalation exposure assessment. The selections were based on the product usage patterns and are believed to provide high end degrees of dermal, inhalation, or incidental ingestion exposure. The representative scenarios assessed in this document are shown in Table 5.

3.0 SUMMARY OF TOXICITY DATA 3.1 Acute Toxicity The acute toxicity is also presented in the toxicological chapter of this RED. The data base for acute toxicity is considered complete. No additional studies are required at this time. The acute toxicity data on the Linear alkylbenzene Sulfonate ( LAS) Technical is summarized below in Table 3.1. Page 11 of 36 Table 3.1. Acute Toxicity Data on Linear alkylbenzene Sulfonate ( LAS):

Guideline No./ Study Type MRID No. Results Toxicity Category 870.1100 Acute oral toxicity Multiple LD50 = range from 404 to over 5000 mg/ kg III IV 870.1200 Acute dermal toxicity 94032006 LD50 = 1200 mg/ kg II 870.1300 Acute inhalation toxicity 003442* LC50 = 200 mg/ L IV 870.2400 Acute eye irritation 0033443* Corneal opacity not reversed at 72 hours. I 870.2500 Acute dermal irritation 003444* Severe irritation at 72 hours II 870.2600 Skin sensitization Open Literature { Nusair TL, PJ Danneman, J Stotte, PHS Bay ( 1988) Consumer Products: Risk Assessment Process for Contact Sensitization, Toxicologist 8: 258. ( HERA)} Weak to moderate sensitization * Tox record No.

3.2 Summary of Toxicity Endpoints Table 4 indicates the toxicological endpoints that were developed for the assessment of the alkylbenzene sulfonates. The complete discussion is included in the toxicological chapter of the alkylbenzene sulfonate RED. Page 12 of 36 Table 4. Summary of Toxicological Dose and Endpoints for Alkylbenzene Sulfonates Exposure Scenario Dose Used in Risk Assessment, UF Special FQPA SF*, endpoint and Level of Concern for Risk Assessment Study and Toxicological Effects Acute Dietary ( All populations) No endpoint was selected. No effects are attributable to a single dose.

Chronic Dietary ( All populations) Systemic/ Reproductive NOAEL= 50 mg/ kg/ day UF = 100 Chronic RfD = 0.5 mg/ kg/ day FQPA SF = 1X cPAD = chronic RfD FQPA SF = 0.5 mg/ kg/ day Systemic/ Reproductive LOAEL = 250 mg/ kg/ day based on decreased Day 21 female pup body weight ( Buehler, E. et al. 1971. Tox. Appl. Pharmacol. 18: 83 91)

plus LOAEL= 145 mg/ kg/ day from 9 month drinking water rat study based on decreased body weight gain, and serum/ biochemical and enzymatic changes in the liver and kidney ( Yoneyama et al. 1976 Ann. Rep. Tokyo Metrop. Res. Lab. Public Health 27( 2): 105 112)

plus LOAEL= 114 mg/ kg/ day ( 0.2%) based on increased caecum weight and slight kidney damage in a 6 month rat dietary study ( Yoneyama et al 1972 Ann. Rep. Tokyo Metrop. Res. Lab. Public Health 24: 409 440)

Short Term Incidental Oral ( 1 30 days) Oral NOAEL= 50 mg/ kg/ day Residential LOC for MOE = 100 Systemic/ Reproductive LOAEL = 250 mg/ kg/ day based on decreased Day 21 female pup body weight ( Buehler, E. et al. 1971. Tox. Appl. Pharmacol. 18: 83 91)

plus LOAEL= 145 mg/ kg/ day from 9 month drinking water rat study based on decreased body weight gain, and serum/ biochemical and enzymatic changes in the liver and kidney ( Yoneyama et al. 1976 Ann. Rep. Tokyo Metrop. Res. Lab. Public Health 27( 2): 105 112)

plus LOAEL= 114 mg/ kg/ day ( 0.2%) based on increased caecum weight and slight kidney damage in a 6 month rat dietary study ( Yoneyama et al 1972 Ann. Rep. Tokyo Metrop. Res. Lab. Public Health 24: 409 440) Page 13 of 36 Table 4. Summary of Toxicological Dose and Endpoints for Alkylbenzene Sulfonates Exposure Scenario Dose Used in Risk Assessment, UF Special FQPA SF*, endpoint and Level of Concern for Risk Assessment Study and Toxicological Effects Short, intermediateand Long Term Inhalation ( 1 to 30 days, 1 6 months, > 6 months) Inhalation study NOAEL= 1mg/ m3 detergent dust combined with up to 0.1 mg/ m3 enzyme dust Equivalent to approximately 0.14 mg/ kg/ day ( a) ( inhalation absorption rate = 100%) purity= 13% active ingredient Residential LOC for MOE = 100 Occupational LOC for MOE = 100 Subchronic Inhalation Monkey Study LOAEL = 10 mg/ m3 detergent combined with 0.1 mg/ m3 enzyme dust based on weight loss and decreased weight gain ( W. Coates, et al 1978. Tox. Appl. Pharmacol. 45: 477 496) This air concentration is equivalent to approximately 1.4 mg/ kg/ day ( a)

Dermal Endpoint Quantification of dermal risk is not required since: 1) the alkylbenzene sulfonates are surfactants that are dermal irritants at concentrations generally greater than 20% solution ( WHO 1996). Thus, dermal exposure would be self limiting to preclude dermal irritation. Most pesticide formulations have less than 5% alkylbenzene sulfonates as an inert ingredient, with the vast majority of household products containing approximately 2%. Additionally, the requirement of the dermal toxicity studies with the end use product will determine whether personal protective clothing would be necessary to protect against irritation during product use; 2) no systemic toxicity was seen following repeated dermal applications to rabbits at 200 mg/ kg/ day ( with an end use product); 3) no developmental toxicity concerns were seen following repeated dermal applications to pregnant mice, rats or rabbits ( developmental effects were seen either in the presence of maternal toxicity or at doses higher than those that caused maternal toxicity); and 4) there is no residential exposure to alkylbenzene sulfonates as an active ingredient, however, residential exposure from its use as an inert ingredient in pesticide formulations is expected to be of an intermittent nature ( i. e, no continuous, constant contact, multi day exposure) from household products.

Cancer ( oral, dermal, inhalation) No evidence of carcinogenicity in reported studies in rats done before 1980 GLPs UF = uncertainty factor, FQPA SF = Special 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, MOE = margin of exposure, LOC = level of concern, NA = Not Applicable NOTE: No Special FQPA Safety Factor recommended because it is assumed that the exposure databases ( dietary food, drinking water, and residential) are complete and that the risk assessment for each potential exposure scenario includes all metabolites and/ or degradates of concern and does not underestimate the potential risk for infants and children. ( a) Equation used to convert inhalation air concentration to a dose= mg/ L* absorption* respiratory volume ( L/ hr)* duration ( hrs) * activity factor / body weight. Thus, 0.001 mg/ L * 1* 67.94 L/ hr ( based on default respiratory volumes for a New Zealand Rabbit which is used as a surrogate for a cynomolgus monkey) * 6 hrs * 1 / 2.98 kg ( body weight for New Zealand Rabbit used as a surrogate for cynomolgus monkey, study reports monkey body weight ranges from 1.6 to 3.7 kg). Page 14 of 36 3.3 FQPA Considerations These considerations are also presented in the toxicological chapter for this RED.

Special Sensitivity to Infants and Children Based on the available hazard data, it doesn't appear that LAS exposure in laboratory animal studies results in any special sensitivity to the young. Therefore, the FQPA factor may be reduced to 1X.

Several reproduction and many developmental studies have been performed with LAS in a number of animal species. In the developmental studies, whenever toxicity was observed in adults, it was generally for mild effects ( slight body weight changes, intestinal disturbances) except for severe dermal irritation effects in dermal developmental studies. Any developmental toxicity observed in these same studies included minor increases in visceral/ skeletal anomalies and some fetal losses; but only at maternally toxic doses.

In one reproduction study ( Buehler et al., 1971), there were slight changes in hematology and histopathology ( both within historical control ranges) and slight decreases in body weight in the offspring at the highest dose of 250 mg/ kg/ d ( at which there were no effects on the parental generation). There were no effects in either the parental or offspring in the other two reproductive toxicity studies ( see Toxicity Profile Table)   high doses of 70 or 170 mg/ kg/ d.

There's no evidence in the literature to indicate any neurotoxic effects of LAS in humans or laboratory animal.

There is no need for a special FQPA factor because the mid dose level of 50 mg/ kg/ d ( NOAEL for offspring effects) in the Buehler study is the basis for the chronic RfD of 50 mg/ kg/ d. Thus, the chronic hazard value is based on slight pup effects and is protective of laboratory animals of all ages in this hazard assessment.

Recommendation for a Developmental Neurotoxicity Study A DNT is not required because there is no evidence of either neurotoxicity or susceptibility to the young following LAS exposure to laboratory animals.

4.0 RESIDENTIAL EXPOSURE ASSESSMENT 4.1 Residential Exposure Based on the Agency's professional judgment, there is no residential exposure to assess at this time for products that contain the alkylbenzene sulfonates as the active ingredient. The Agency acknowledges that there are labels with language which initially appear to warrant a residential assessment, and these specific labels are discussed below along with justification for not conducting the residential risk assessment. Again, to reiterate, there is a separate dietary chapter that will be provided for the dietary risks that stem from the use of products containing alkylbenzene sulfonates. There will also be a separate inert chapter to assess the exposure to products that contain alkylbenzene sulfonates as the inert ingredient. Page 15 of 36   Reg. # 71094 1 ( PRO SAN), and # 71094 2 ( PRO SAN L) direct use on but not limited to the following food preparation areas: countertops, cutting boards, dishes and utensils that are found in kitchens, restaurants, and other eating establishments along with dairies and food processing plants. The method of application for these surfaces includes brush, wiping, foam, sponge, or low pressure spray. These labels also include directions for fruit and vegetable washing via immersion, spraying, scrubbing ( with a mesh pad, brush, or by mechanical agitation). There is also a use for circulation cleaning and sanitizing of equipment ( such as soft ice cream, juice, and vending machines).

Based on the titles of these products indicating " professional sanitation" along with the use patterns and use rates on these labels, it is assumed that these products are distributed to commercial or industrial users, and not to residential handlers. There is no indication that excludes residential use sites, and it is suggested that language is included on these labels to restrict the use sites so that there is no risk of these products ending up in the hands of residential homeowners.

Several of the labels also restrict label use to industry only but there are some exceptions in which a label was not exclusive to industrial applications. In these cases, label language and use sites were used to justify that a residential risk assessment is not warranted at this time.

  Some of the labels that did not restrict product usage to industrial applications. These labels include but are not limited to the following use sites: food processing equipment in dairies, beverage, and food processing plants ( Reg. Numbers associated with this statement include: # 1670 150, # 1270 254, # 4959 29, # 9152 18, # 150 61, and # 2686 10). Due to the use sites that were directed on these labels, there appears to be no residential risk.   This group of labels does not restrict product use to industrial applications and there is the use site category of, " institutional premises." The Agency includes daycares as a potential facility included in the institutional category. Based on the language of these labels, there appears to be no risk to children in daycares ( post application exposure to treated floors) because of the specific surfaces that the products are applied to. These include but are not limited to food serving equipment, dishes, utensils, pots, and pans ( Reg. Numbers associated with this statement include: # 74210 1, # 875 85, # 875 185, # 1677 56, # 5389 12, # 5174 11, # 65001 1).   Label Reg. # 3635 279 includes the cleaning of toilets and shower stalls, but the label restricts the use of the product to industrial, institutional, and commercial premises. In addition, the surfaces to be cleaned are restricted to toilets and shower stalls so that there is no expected post application exposure risk for children's exposure to treated floors in daycares.   Label Reg. # 7546 4 has language that specifies that institutional and commercial premises are the use sites, but does restrict use of the product to: food service areas of public eating places, healthcare facilities, schools, and bars for the purpose of sanitizing glassware and other utensils. Again, it is assumed that there is no post application exposure risk for children on treated floors in daycares. Page 16 of 36 5.0 OCCUPATIONAL EXPOSURE ASSESSMENT The exposure scenarios that are assessed in this document for the representative uses for sodium dodecylbenzene sulfonate, dodecylbenzene sulfonic acid, and benzenesulfonic acid, C10 C16 alkyl derivatives are shown in Tables 5. The table shows the maximum application rate associated with the representative use and the appropriate EPA Registration number for the product label. Potential occupational handler exposure can occur in various use sites, which include; agricultural premises, food handling premises, and commercial/ institutional/ industrial premises. It should be noted that for the calculation of application rates in which 8.34 lb a. i./ gal is noted, the product is assumed to have the density of water because it is diluted with water.

However, it will be apparent that throughout Table 5, that some of the application methods are repeated. This is because when the labels that contain sodium dodecylbenzene sulfonate as the active ingredient were not chosen to be the representative label for all of the sulfonates ( e. g. highest application rate), they still had to be included so that the total MOE assessment could be conducted. This was necessary because all of the products that contain sodium dodecylbenzene sulfonate as the active ingredient have label direction for the product to be used for both cleaning and sanitizing in the same time frame. For this reason, the risks resulting from the use of the products that contain sodium dodecylbenzene sulfonate were assessed individually, even if they were not chosen as the representative scenarios. Subsequently, these handful of labels were then assessed jointly to generate a total exposure assessment ( combined scenarios are identified in Table 6).

There are also some application methods that are assumed to be similar, but are only different in wording. The CIP ( Cleaning in Place), circulation, flow method, and flushing methods are all assumed to be the same in terms of quantity handled and unit exposure values. For example, label Reg. # 5389 12 states, " For closed CIP systems, fill the system with fresh sanitizer solution and allow the solution to stay in contact with internal parts for 10 minutes before draining the system. For circulating CIP dairy dispensing systems, circulate a fresh sanitizer solution through the dairy dispensing machine for 10 minutes before draining the machine." Label Reg. # 9152 18 states, " To sanitize by flow method: add 1oz. [ product] to 2 gallons water. Pump through the system..." These specific examples support that these methods can be assessed as one group when they are applied to the same use site. Also, these methods of application are via closed systems. So any potential human exposure is expected to occur when the solution to be placed in the system is prepared or for the process of loading the solution into the system to be cleaned. Page 17 of 36 Table 5: Representative Exposure Scenarios Associated with Occupational Exposures to Alkylbenzene Sulfonates Representative Use Method of Application Exposure Scenario Registration # Application Rate1 Agricultural Premises and Equipment ( Use Site Category I)

  Brush   Mechanical Foam ST and IT Handler: inhalation 74210 12 0.0667 lb ai/ gal ( 25.6% ai x 4 oz product/ gal water x 1 gal/ 128 oz x 8.34 lb/ gal)

  Flooding ST and IT Handler: inhalation 875 185 0.00183 lb ai/ gal ( 4.5% ai x 2.5 oz product/ 4 gal water x 1 gal/ 128 oz x 8.34 lb/ gal)

  Flushing3   Circulation/ recirculation system3   Flow method3 ST and IT Handler: inhalation 4959 29 0.00195 lb ai/ gal ( 15% ai x 1 oz product/ 5 gal water x 1 gal/ 128 oz x 8.34 lb/ gal)

  High pressure spray4 ST and IT Handler: inhalation 875 85 0.00326 lb ai/ gal ( 5% ai x 2 oz product/ 2 gal water x 1 gal/ 128 oz x 8.34 lb/ gal) Indoor Hard Surfaces ( includes stainless steel, plastic, tiles)

  Immersion   Low pressure spray   Trigger pump spray ST and IT Handler: inhalation 74210 12 0.00334 lb ai/ gal ( 25.6% ai x 2 oz product/ 10 gal water x 1 gal/ 128 oz x 8.34 lb/ gal)

Food Handling ( Use Site Category II)

  Brush5   Mechanical foam6 ST and IT Handler: inhalation 74210 12 0.0667 lb ai/ gal ( 25.6% ai x 4 oz product/ gal water x 1 gal/ 128 oz x 8.34 lb/ gal)

  Brush ( sanitize) ST and IT Handler: inhalation 0.0115 lb ai/ gal ( 2.75% ai x 5% solution x 8.34 lb/ gal)

  Brush ( cleaning) ST and IT Handler: inhalation 1020 132,7 0.0018 lb ai/ gal ( 2.75% ai x 1oz. product/ gal water x 1 gal/ 128 oz x 8.34 lb/ gal)

  Brush ( cleaning) ST and IT Handler: inhalation 71094 12,8 ( WSP) 9 0.00603 lb ai/ gal ( 3.6% ai x 0.67 lb product/ 4 gal water)

  Brush ( cleaning) ST and IT Handler: inhalation 71094 22,10 ( RTU) 9 0.00300 lb ai/ gal ( 0.036% ai x 8.34 lb/ gal) Indoor Hard Surfaces ( includes dishes and silverware)

  Foaming ( cleaning) ST and IT Handler: inhalation 71094 12,8 ( WSP) 9 0.00603 lb ai/ gal ( 3.6% ai x 0.67 lb product/ 4 gal water) Page 18 of 36 Table 5: Representative Exposure Scenarios Associated with Occupational Exposures to Alkylbenzene Sulfonates Representative Use Method of Application Exposure Scenario Registration # Application Rate1   Circulation system11   Flushing11   Flow method11   Immersion   Trigger pump sprayer ST and IT Handler: inhalation 74210 12 0.00334 lb ai/ gal ( 25.6% ai x 2 oz product/ 10 gal water x 1 gal/ 128 oz x 8.34 lb/ gal)

  Low pressure spray ( cleaning) 0.00603 lb ai/ gal ( 3.6% ai x 0.67 lb product/ 4 gal water)

  Low pressure spray ( sanitizing) ST and IT Handler: inhalation 71094 12,8 ( WSP) 9 0.00302 lb ai/ gal ( 3.6% ai x 0.67 lb product/ 8 gal water)

  Low Pressure Spray ( cleaning)

  Trigger pump ( sanitize) ST and IT Handler: inhalation 71094 22,10 ( RTU) 9 0.00300 lb ai/ gal ( 0.036% ai x 8.34 lb/ gal)

  High pressure spray ( sanitize) 12 0.0115 lb ai/ gal ( 2.75% ai x 5% solution x 8.34 lb/ gal)

  High pressure spray ( cleaning) ST and IT Handler: inhalation 1020 132,7 0.0018 lb ai/ gal ( 2.75% ai x 1oz. product/ gal water x 1 gal/ 128 oz x 8.34 lb/ gal)

  Immersion ( sanitizing)

  Flooding ( sanitizing) ST and IT Handler: inhalation 71094 12,8 ( WSP) 9 0.00302 lb ai/ gal ( 3.6% ai x 0.67 lb product/ 8 gal water)

  Immersion ( sanitizing)

  Flooding ( sanitizing) ST and IT Handler: inhalation 71094 22,10 ( RTU) 9 0.00300 lb ai/ gal ( 0.036% ai x 8.34 lb/ gal)

  Mop ST and IT Handler: inhalation 65001 113 0.00244 lb ai/ gal ( 15% ai x 1 oz/ 4 gal water x 1 gal/ 128 oz x 8.34 lb/ gal)

  Wiping surfaces ( cleaning) ST and IT Handler: inhalation 71094 12,8 ( WSP) 9 0.00603 lb ai/ gal ( 3.6% ai x 0.67 lb product/ 4 gal water)

  Sponge/ Mesh/ Wiping ( cleaning) ST and IT Handler: inhalation 71094 22,10 ( RTU) 9 0.00300 lb ai/ gal ( 0.036% ai x 8.34 lb/ gal)

CIP ( cleaning) 14 ST and IT Handler: inhalation 1020 13 0.00358 lb ai/ gal ( 2.75% ai x 2 oz product/ gal water x 1 gal/ 128 oz x 8.34 lb/ gal) Page 19 of 36 Table 5: Representative Exposure Scenarios Associated with Occupational Exposures to Alkylbenzene Sulfonates Representative Use Method of Application Exposure Scenario Registration # Application Rate1   Circulation systems/ flow method ST and IT Handler: inhalation 74210 1 0.00334 lb a. i./ gal ( 25.6% a. i. x 2 oz product/ 10 gal water x 1 gal/ 128 oz x 8.34 lb/ gal)

  Circulations systems ( cleaning) 0.00603 lb ai/ gal ( 3.6% ai x 0.67 lb product/ 4 gal water) Food dispensing equipment   Circulations systems ( sanitize) ST and IT Handler: inhalation 71094 1 0.00302 lb ai/ gal ( 3.6% ai x 0.67 lb product/ 8 gal water)

  Immersion ST and IT Handler: inhalation 71695 1 0.00455 lb a. i./ gal ( 17.46 % a. i. x 2 oz/ 5 gal water x 1 gal/ 128 oz x 8.34 lb/ gal)

  Immersion ST and IT Handler: inhalation 71094 1 0.00603 lb ai/ gal ( 3.6% ai x 0.67 lb product/ 4 gal water) Fruit and Vegetable washing   Trigger pump spray ST and IT Handler: inhalation 71094 2 0.00300 lb ai/ gal ( 0.036% ai x 8.34 lb/ gal) Commercial/ Institutional and Industrial Premises and Equipment ( Use Site Category III)

  Brush   Mechanical foam6 ST and IT Handler: inhalation 74210 12 0.0667 lb ai/ gal ( 25.6% ai x 4 oz product/ gal water x 1 gal/ 128 oz x 8.34 lb/ gal) Indoor Hard Surfaces ( includes dishes and silverware)

  Immersion   Low pressure sprayer   Trigger pump sprayer ST and IT Handler: inhalation 74210 12 0.00334 lb ai/ gal ( 25.6% ai x 2 oz product/ 10 gal water x 1 gal/ 128 oz x 8.34 lb/ gal)

  Mopping ST and IT Handler: inhalation 3635 279 0.0177 lb ai/ gal ( 15.52% ai x 1.75 oz/ gal water x 1 gal/ 128 oz x 8.34 lb/ gal) Shower Stalls/ toilets   Liquid pour   Wiping ST and IT Handler: inhalation 3635 279 1.49 lb ai/ gal ( 15.52% ai x 9.61 lb/ gal) 15 1. All application rates for the soluble concentrate and ready to use liquid products were calculated assuming the product has the same density as water ( 8.34 lb/ gal). 2. This product can be used on food contact surfaces in industrial premises. 3. Flushing, circulation and flow method are considered to be the same application method. Flow method, as described on label # 9152 18 is "  pump[ ing] through system until full flow is obtained  close drain valves  drain solution, and air dry." 4. High pressure spray is assumed to be representative of a " coarse droplet spray" per label # 833 75 and # 875 184 which both state " high pressure spray cleaning using a coarse droplet". 5. Label Reg. # 74210 1 has language that states for manual cleaning ( brush or scrub), 1 2 ounces of product should be diluted with a gallon of water. The label also has a general direction that the product is to be used on all hard nonporous surfaces in industrial use sites. The label also has the direction for mechanical foam application listed as 4 ounces product/ gallon of water is to be applied, " to surfaces by manual procedures or by mechanical foam." It is assumed Page 20 of 36 that " manual procedures" is indicative of brush applications. 6. Mechanical foam is listed for mineral film removal and regular foaming is listed as a general cleaning instruction. These methods are listed on the same label with application specific use rates, which is why they are both listed in the table. However, for assessment purposes, mechanical foam and regular foaming share the same unit exposure values. Also, the application rate for mechanical foam is higher than that for regular foaming, so the mechanical foaming application is assumed representative for the foaming application. 7. Label Reg. # 1020 13 states that there is a cleaning step and a sanitizing step, and there are different application rates for each of these steps. The label does not specify which method of application for cleaning and sanitizing should follow each other ( i. e. coarse spray sanitizing followed by either coarse spray rinse or brush rinse). Because the cleaning and sanitizing step occur in the same time frame, a total exposure effect will result. 8. Label Reg. # 71094 1 states that there is a cleaning step and a sanitizing step. According to label # 71094 1, the cleaning step involves application of the product through brush, foam, wipe or low pressure spray and the sanitizing step involves application of the product through immersion, flooding, or spraying. The label does not specify which methods of cleaning and sanitizing steps should be used jointly. Because the cleaning and sanitizing step occur in the same time frame, a total exposure effect will result. 9. Exposure to both the water soluble packing and ready to use formulation were assessed. Even though the water soluble packaging ( 0.67 lbs) has a higher application rate, the unit exposure values for ready to use products ( liquid pour data) are higher. 10. Label Reg. # 71094 2 states that there is a cleaning step and a sanitizing step. According to label # 71094 2, the cleaning step involves application of the product through sponge, brush, mesh, wipe or low pressure spray and the sanitizing step involves application of the product through immersion, flooding, or spraying. The label does not specify which methods of cleaning and sanitizing steps should be used jointly. Because the cleaning and sanitizing step occur in the same time frame, a total exposure effect will result. 11. CIP, circulation system, flushing and flow method are all considered to be the same application method in terms of potential exposure. 12. Coarse spraying, as directed on label # 1020 13 is assumed to be analogous with " coarse droplet spray" per labels # 833 75 and# 875 184 which states " high pressure spray cleaning using a coarse droplet". As a result, unit exposures for this scenario use those developed for high pressure spray. 13. The label Reg. # 65001 1 lists 1 ounce per 4 gallons of water for the directed dilution. This is equivalent to 200ppm. The label states the ppm concentration that can be allowed for the product to be 300 ppm. This value is equivalent to 1 ounce of product per 4 gallons of water dilution, and this is the value that was used in the assessment. 14. CIP = cleaning in place; metered/ closed system application 15. Because the product is applied directly as a concentrate to clean and disinfect, the density of the product itself, not water, was used in the calculation Page 21 of 36 Table 6 Representative Exposure Scenarios Assessed for the Products that Contain Sodium Dodecylbenzene Sulfonate as the Active Ingredient Representative Use Registration # Method of CLEANING Application Method of SANITIZING Application Groups assessed 1 Food Handling/ Storage Establishments Premises and Equipment ( Use Site Category II)

1020 13 High Pressure spray Brush High Pressure spray Brush High pressure spray with high pressure spray or brush Brush with high pressure spray or brush 71094 1 Low pressure spray Wiping Foam Brush Immersion Flooding Low pressure spray Low pressure spray with immersion/ flooding, or low pressure spray Wiping with immersion/ flooding, or low pressure spray Foam with immersion/ flooding, or low pressure spray Brush with immersion/ flooding, or low pressure spray 71094 2 Sponge/ Mesh/ Wip ing Low Pressure Spray Brush Immersion Flooding Trigger Pump Sponge with immersion/ flooding, or spraying Low pressure spray with immersion/ flooding, or spraying Brush with immersion/ flooding, or spraying Indoor Hard Surfaces ( includes dishes and silverware)

1020 13 CIP ( liquid pour) CIP ( liquid pour) Liquid pour for both the cleaning and sanitizing steps Food dispensing equipment 71094 1 Circulation system ( solid place) Circulation system ( solid place ) Solid place for both the cleaning and sanitizing steps Fruit and Vegetable Washing There are no separate steps for cleaning and sanitizing for this use site, it only involves cleaning.

1: The groups that are listed are the different combinations of cleaning and sanitizing methodologies that can subsequently occur. These are the combinations that are assessed in Table 8. Page 22 of 36 5.1 Occupational Handler Exposures The occupational handler scenarios included in Tables 5 and 6 were assessed to determine baseline inhalation exposures. The general assumptions and equations that were used to calculate occupational handler risks are provided in Appendix A. The majority of the scenarios were assessed using CMA data and Equations 1 3 in Appendix A. However, for the occupational scenarios in which CMA data were insufficient, other data and methods were applied. The majority of the labels assessed for this chapter indicate that PPE ( gloves, protective clothing, and goggles/ face shield) are to be used. At this time, there is no dermal endpoint that has been calculated for this chemical. Because of this, there was no dermal assessment conducted.

There are also total MOEs that are presented in Table 8, which were calculated because of the use direction found on the labels that contain sodium dodecylbenzene sulfonate as the active ingredient. The scenarios that are assessed in this table were extracted from Table 6. The total MOE was calculated using the following equation:

Total MOE = 1 / (( 1/ MOEsanitizing) + ( 1/ MOEcleaning))

Unit Exposure Values ( UE): Inhalation unit exposure values were taken from the proprietary Chemical Manufacturers Association ( CMA) antimicrobial exposure study ( USEPA, 1999: DP Barcode D247642) or from the Pesticide Handler Exposure Database ( USEPA, 1998).

  For the low pressure handwand scenarios, the CMA inhalation unit exposure value for the use of a low pressure spray was used, 0.681 mg/ lb a. i. This value is based on data collected from eight replicates in which the applicator hand sprayed carpet using 200 psi, then used a push broom rake to raise the carpet nap.   For the high pressure spray scenario, the occupational PHED inhalation unit exposure value for liquid/ open pour/ high pressure spray were used. The inhalation unit exposure value is 0.12 mg/ lb a. i.   For the mopping scenarios, the CMA inhalation unit exposure value for mopping was used, 2.38 mg/ lb a. i. This value is based on data collected from six replicates in which the applicator mopped the floor and received exposure via contact with the mop or with the bucket.   For the wiping scenario, the CMA inhalation unit exposure value for wiping was used, 67.3 mg/ lb a. i. This value is based on data collected from six replicates ( dental technicians) who used a finger pump sprayer to apply the product and then wiped the surfaces with a paper towel.   For the liquid pour scenario CMA disinfectant liquid pour inhalation unit exposure value was used. The inhalation unit exposure value is 1.89 mg/ lb a. i. This value is based on data collected from two replicates involving pouring a disinfectant product from a jug into sterilization trays designed for dental instruments, adding water and instruments to the tray, removing the instruments, and discarding the old solution.   For the brush scenario, the occupational PHED inhalation unit exposure value for paintbrush applications was used. The inhalation exposure value is 0.28 mg/ lb a. i.   For the trigger pump spray, foam, and mechanical foam scenarios, the PHED inhalation unit exposure value for aerosol applications ( PHED scenario 10) was used. The inhalation unit exposure is 1.3 mg/ lb a. i. Page 23 of 36   For CIP ( Cleaning in Place), immersion, and flooding for the label that indicates that the product is a water soluble packaging ( Reg. # 71094 1), the PHED data for use of a wettable powder/ water soluble bag was used, and the value is, 0.00024 mg/ lb a. i.   For CIP ( Cleaning in Place), immersion, flooding, flow method, circulation, and flushing, in which soluble concentrate formulations were used, For soluble concentrate formulations, the CMA disinfectant liquid pour for disinfectants inhalation unit exposure value was used. The inhalation unit exposure value is 1.89 mg/ lb a. i. This value is based on data collected from two replicates pouring a disinfectant product from a jug into sterilization trays designed for dental instruments, adding water and instruments to the tray, removing the instruments, and discarding the old solution.

Quantity handled/ treated: The quantity handled/ treated values were estimated based on information from various sources. The following assumptions were made:

  For the low pressure handwand scenario, 10 gallons of solution are used for agricultural uses ( Exposure Policy # 009) and AD's standard assumption is that 2 gallons are used in all other applications.   For the high pressure spray scenario, it was assumed that 40 gallons of solution are used ( Exposure Policy # 009).   For the mopping scenario, AD's standard assumption is that 2 gallons of solution are used in the food handling and commercial/ institutional/ industrial setting.   For the wiping, brush, trigger pump spray, liquid pour, foam and mechanical foam scenarios AD's standard assumption is that 1 L ( 0.26 gallons) is used.   For the immersion and flooding scenarios, the quantities listed on the label range from 1 gallon ( i. e. label Reg. # 5389 12) up to 10 gallons and appear to be either for fruit or vegetable cleaning/ sanitizing These application methods are used interchangeably, such as on Reg. # 875 185, " To sanitize [ e. g.: utensils]... by immersion, flooding, or spraying..." AD's standard assumption is that 10 gallons is the amount used, and assumes that the quantities handled for immersion and flooding are the same. The way that the term " flooding" is used on labels does not appear to indicate the flooding of large hard surfaces in industrial plants.   For the CIP, circulation/ recirculation, flow method, and flushing scenarios, the labels indicate that CIP lines can be filled to its capacity so the product can circulate/ flush the system and then be drained. However, labels do not specify the size of a CIP system. AD's standard assumption is that that 10,000 gallons is the capacity of the CIP line, and 10,000 gallons is the value that was used for conducting the assessment.

Duration of Exposure: Potential doses were calculated for the short and intermediate term durations for occupational handlers. The alkylbenzene sulfonates have a low vapor pressure as indicated in Table 2, Physical/ Chemical Properties of Alkylbenzene Sulfonates ( less than 10 9), so that any standing solutions that may result in post application exposure were deemed negligible. Page 24 of 36 Exposure Calculations and Results The calculated baseline inhalation doses and baseline MOEs for the alkylbenzene sulfonates are shown in Table 7, and the total MOE calculations for the labels that contain sodium dodecylbenzene sulfonate are listed in Table 8. The reason that a baseline inhalation assessment was conducted was because of the use sites of the labels. The Agency believes it is not practicable, based on the product usage, that a respirator can be required on the handler ( e. g. janitorial services). In addition, engineering controls are not feasible for the current use patterns on the labels. All of MOEs in the occupational setting were above the target MOE of 100 for inhalation and total exposures, except for the following scenarios:

Handler Risk Summary for alkylbenzene sulfonates:

  ST and IT inhalation exposure from cleaning hard surfaces via circulation/ flow/ flushing in the agricultural premises and equipment category, inhalation MOE = 0.27.   ST and IT inhalation exposure from application to hard surfaces via circulation systems/ flow method in the food handling category, inhalation MOE = 0.16.   ST and IT inhalation exposure from cleaning hard surfaces via wiping in the food handling category, inhalation MOE = 93.   ST and IT inhalation exposure from application to hard surfaces via CIP ( Cleaning in Place) in the food handling premises category, inhalation MOE = 0.14.   ST and IT inhalation exposure from cleaning food dispensing equipment via circulation systems/ flow method in the food handling category, inhalation MOE = 0.16.   ST and IT Inhalation exposure from cleaning shower stalls and toilets via a liquid pour application in the commercial/ institutional premises, inhalation MOE = 13.   ST and IT inhalation exposure from cleaning shower stalls and toilets via wiping in the commercial/ institutional premises, inhalation MOE = 0.38.

Total Exposure Summary for sodium dodecylbenzene sulfonate ( results from cleaning and sanitizing with the same product in the same time frame)

  ST and IT inhalation exposure from cleaning indoor hard surfaces via wiping and then following with sanitizing via immersion/ flooding in the food handling premises category, inhalation MOE = 93.   ST and IT inhalation exposure from cleaning indoor hard surfaces via wiping and then following with sanitizing via low pressure spray in the food handling premises category, inhalation MOE = 90.   ST and IT inhalation exposure from cleaning indoor hard surfaces via sponge/ mesh/ wiping and then sanitizing via immersion/ flooding in the food handling premises category, inhalation MOE = 90.   ST and IT inhalation exposure from cleaning and sanitizing steps to be conducted through CIP ( Cleaning in Place) in the food handling premises category, inhalation MOE = < 1. Page 25 of 36 Table 7: Short and Intermediate Term Risks Associated with Occupational Handlers Using Products Containing Alkylbenzene Sulfonates Unit Exposure ( mg/ lb a. i.) Daily Dose ( mg/ kg/ day) a Baseline MOEb Exposure Scenario Method of Application Inhalation App. Rate ( lb ai/ gal) Quantity Handled/

Treated per day ( gal) Inhalation Inhalation ( Target MOE = 100)

Agricultural Premises and Equipment ( Use Site Category I)

Brush 0.28 0.0667 0.26 6.9x10 5 2,000 Mechanical Foamc 1.3 0.0667 0.26 0.00032 430 Flooding 1.89 0.00183 10 0.00049 280 Circulation, flow,

flushing 1.89 0.00195 10,000 0.53 0.27j High Pressure spray 0.12 0.00326 40 0.00022 630 Immersion 1.89 0.00334 10 0.0009 160 Low pressure spray 0.681 0.00334 10 0.00032 430 Application to hard surfaces Trigger Pump Spray 1.3 0.00334 0.26 1.6x10 5 8,700 Food Handling ( Use Site Category II)

Brush 0.28 0.0667 0.26 6.9x10 5 2,000 Mechanical Foam c 1.3 0.0667 0.26 0.00032 430 Brush ( sanitize) d 0.28 0.0115 0.26 1.2x10 5 12,000 Brush ( Clean) d 0.28 0.0018 0.26 1.8x10 6 75,000 Brush ( clean) e 0.28 0.00603 0.26 6.3x10 6 22,000 Brush ( clean) f 0.28 0.003 0.26 3.1x10 6 45,000 Foam ( clean) e 1.3 0.00603 0.26 2.9x10 5 4,800 circulation, flushing,

flow method 1.89 0.00334 10,000 0.9 0.16j Immersion 1.89 0.00334 10 0.0009 160 Trigger Pump Spray 1.3 0.00334 0.26 1.6x10 5 8,700 Application to hard surfaces Low pressure handwand( clean) e 0.681 0.00603 2 0.00012 1,200 Page 26 of 36 Table 7: Short and Intermediate Term Risks Associated with Occupational Handlers Using Products Containing Alkylbenzene Sulfonates Unit Exposure ( mg/ lb a. i.) Daily Dose ( mg/ kg/ day) a Baseline MOEb Exposure Scenario Method of Application Inhalation App. Rate ( lb ai/ gal) Quantity Handled/

Treated per day ( gal) Inhalation Inhalation ( Target MOE = 100)

Low pressure handwand ( sanitize) e 0.681 0.00302 2 5.9x10  5 2,400 Low pressure spray ( clean) f 0.681 0.003 2 5.8x10 5 2,400 Trigger pump ( sanitize) f 1.3 0.003 0.26 1.4x10 5 9,700 High pressure spray ( sanitize) d 0.12 0.0115 40 0.00079 180 High pressure spray ( Clean) d 0.12 0.0018 40 0.00012 1,100 Immersion, flooding for WSP ( sanitize) e, g 0.00024 0.00302 10 1.0x10 7 1.4x106 Immersion, flooding for RTU ( sanitize) f, g 1.89 0.0030 10 0.00081 170 Mopping 2.38 0.00244 2 0.00017 840 Wiping ( clean) e 67.3 0.00603 0.26 0.0015 93 Sponge/ mesh wipe ( clean) f 67.3 0.003 0.26 0.00075 190 CIP ( clean and sanitize) d, h 1.89 0.00358 10,000 0.97 0.14j Circulation systems,

Flow method 1.89 0.00334 10,000 0.9 0.16j Circulation system ( clean) e 0.00024 0.00603 10,000 0.00021 680 Food dispensing equipment Circulation system ( santiize) e 0.00024 0.00302 10,000 0.0001 1,400 Immersion 1.89 0.00455 10 0.0012 110 Fruits and vegetables Immersion ( clean) i 0.00024 0.00603 10 2.0x10 7 6.8x105 Page 27 of 36 Table 7: Short and Intermediate Term Risks Associated with Occupational Handlers Using Products Containing Alkylbenzene Sulfonates Unit Exposure ( mg/ lb a. i.) Daily Dose ( mg/ kg/ day) a Baseline MOEb Exposure Scenario Method of Application Inhalation App. Rate ( lb ai/ gal) Quantity Handled/

Treated per day ( gal) Inhalation Inhalation ( Target MOE = 100)

Trigger pump spray ( clean) i 1.3 0.003 0.26 1.4x10 5 9,700 Commercial/ Institutional Premises ( Use Site Category III )

Brush 0.28 0.0667 0.26 6.9x10 5 2,000 Mechanical Foamc 1.3 0.0667 0.26 0.00032 430 Immersion 1.89 0.00334 10 0.0009 160 Low Pressure Handwand 0.681 0.00334 2 6.5x10  5 2,200 Application to hard surfaces ( includes utensils and silverware) Trigger Pump Spray 1.3 0.00334 0.26 1.6x10 5 8,700 Mopping 2.38 0.0177 2 0.0012 120 Liquid pour 1.89 1.49 0.26 0.01 13 Shower stalls and toilets Wiping 67.3 1.49 0.26 0.37 0.38 ST = short term, IT = intermediate term a Daily dose ( mg/ kg/ day) = [ unit exposure ( mg/ lb ai) * absorption ( 1.0 for ST/ IT inhalation) * application rate ( lb ai/ gal) * quantity treated ( gal) / Body weight ( 70 kg).

b MOE = NOAEL ( mg/ kg/ day) / Daily Dose, where NOAEL = 0.14 mg/ kg/ day.

c Represents foam and mechanical foam because it has the highest application rate of the two. Foam and mechanical foaming are assumed to share the same unit exposure values.

d These uses are assessed based on the rates found on label Reg. # 1020 13, and the active ingredient is sodium dodecylbenzene sulfonate.

e These uses are assessed based on the rates found on label Reg. # 71094 1 ( WSP), and the active ingredient is sodium dodecylbenzene sulfonate.

f These uses are assessed based on the rates found on label Reg. # 71094 2 and the active ingredient is sodium dodecylbenzene sulfonate.

g Exposure to both the water soluble packing ( WSP) and ready to use ( RTU) formulation were assessed. Even though the water soluble packaging has a higher application rate, the unit exposure values for ready to use, which is represented by liquid pour, are higher.

h This method is done twice in a row, so this CIP method is carried out twice, and each step is considered a cleaning and then sanitizing step.

i These methods of application at these use sites only involve cleaning steps and no other subsequent sanitizing steps.

j The daily doses are most likely over calculated due to the assumption that such a large quantity is being handled for CIP systems, and as a result, the MOEs are extremely low.

This is further elaborated on in the Data Uncertainties. Page 28 of 36 Table 8 ( derived from the combinations of cleaning and sanitizing steps outlined in Table 6) presents the total baseline MOE calculations, which presents the risk to occupational handlers that use products that contain sodium dodecylbenzene sulfonate as the active ingredient. These handful of labels that contain this active ingredient are unique to this RED because they direct the user to both clean and sanitize in the same time frame with the same product. The parenthetical numbers are a reiteration of the MOEs calculated and then presented in Table 7, and then the total MOE was calculated using the following equation:

Total MOE = 1 / (( 1/ MOEsanitizing) + ( 1/ MOEcleaning))

Table 8 Short and Intermediate Term Inhalation Risks to Occupational Handlers Cleaning and Sanitizing with Products That Contain Sodium Dodecylbenzene Sulfonate Representative Use Registration # Method of CLEANING Application Method of SANITIZING Application Total Baseline Inhalation MOE ( Target MOE = 100)

Food Handling/ Storage Establishments Premises and Equipment ( Use Site Category II)

High pressure spray ( 180) 150 High pressure spray ( 1,100)

Brush ( 12,000) 1,000 High pressure spray ( 180) 180 1020 13 Brush ( 75,000)

Brush ( 12,000) 10,000 Immersion/ Flooding ( 1.4X106) 1,200 Low pressure spray ( 1,200)

Low pressure spray ( 2,400) 800 Immersion/ Flooding ( 1.4X106) 93 Wiping ( 93)

Low pressure spray ( 2,400) 90 Immersion/ Flooding ( 1.4X106) 4,800 Foam ( 4,800)

Low pressure spray ( 2,400) 1,600 Immersion/ Flooding ( 1.4X106) 22,000 71094 1 Brush ( 22,000)

Low pressure spray ( 2,400) 2,200 Immersion/ Flooding ( 170) 90 Sponge/ Mesh/ Wiping ( 190)

Trigger Pump ( 9,700) 190 Immersion/ Flooding ( 170) 160 Low Pressure Spray ( 2,400) Trigger Pump ( 9,700) 1,900 Indoor Hard Surfaces ( includes dishes and silverware)

71094 2 Brush ( 45,000) Immersion/ Flooding ( 170) 170 Page 29 of 36 Table 8 Short and Intermediate Term Inhalation Risks to Occupational Handlers Cleaning and Sanitizing with Products That Contain Sodium Dodecylbenzene Sulfonate Representative Use Registration # Method of CLEANING Application Method of SANITIZING Application Total Baseline Inhalation MOE ( Target MOE = 100)

Trigger Pump ( 9,700) 8,000 1020 13 CIP ( 0.14) CIP ( 0.14) < 1 Food dispensing equipment 71094 1 Circulation system ( 680) Circulation system ( 1,400) 450 5.2 Occupational Post application Exposures Occupational inhalation post application exposures are presumed to be negligible because of the low vapor pressure of the alkylbenzene sulfonates.

5.3 Data Limitations/ Uncertainties There are several data limitations and uncertainties associated with the occupational handler exposure assessment. These include:

  Surrogate dermal and inhalation unit exposure values were taken from the proprietary Chemical Manufacturers Association ( CMA) antimicrobial exposure study ( USEPA, 1999: DP Barcode D247642) or from the Pesticide Handler Exposure Database ( USEPA, 1998) ( See Appendix A for summaries of these data sources). Since the CMA data are of poor quality, the Agency requests that confirmatory data be submitted to support the occupational scenarios assessed in this document.   The quantities handled/ treated were estimated based on information from various sources, including HED's Standard Operating Procedures ( SOPs) for Residential Exposure Assessments ( USEPA 2000, and 2001) and the AD Draft SOP use table. In certain cases, no standard values were available for some scenarios. Assumptions for these scenarios were based on AD estimates and could be further refined with input from registrants.   The aerosol can unit exposure data from PHED were used to assess application to hard surfaces by foam. The aerosol can scenario may not be representative of foam application, however, for lack of better data, these values were used.   It was assumed that most of the exposure to the handler stemming from the use of the product for CIP ( Cleaning in Place), immersion, flooding, flow method, circulation, and flushing, will result from preparation of the treatment solution and then pouring it into the corresponding system to be treated. It is also assumed that there is minimal contact with the solution during the treatment process.   It was assumed that for the CIP systems, that the quantity handled is the same what is assumed for food pasteurization systems since CIP systems can be filled to its capacity so the product can circulate/ flush the system and then be drained. However, labels do not specify the size of a CIP system. The Agency assessed the scenario with the assumption that 10,000 gallons is the capacity of the CIP line. This is most probable the reason for the extremely low MOEs for this use site. This value can be further refined with input from the registrants. Page 30 of 36 Page 31 of 36 6.0 REFERENCES USEPA. 1997. Standard Operating Procedures ( SOPs) for Residential Exposure Assessments. EPA Office of Pesticide ProgramsBHuman Health Effects Division ( HED). Dated December 18, 1997.

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

USEPA. 1998. PHED Surrogate Exposure Guide. Estimates of Worker Exposure from the Pesticide Handler Exposure Database Version 1.1. Washington, DC: U. S. Environmental Protection Agency.

USEPA. 1999. Evaluation of Chemical Manufacturers Association Antimicrobial Exposure Assessment Study. Memorandum from Siroos Mostaghimi, Ph. D., USEPA, to Julie Fairfax,

USEPA. 2000. Residential SOPs. EPA Office of Pesticide ProgramsBHuman Health Effects Division. Dated April 5, 2000.

USEPA. 2001. HED Science Advisory Council for Exposure. Policy Update, November 12. Recommended Revisions to the Standard Operating Procedures ( SOPs) for Residential Exposure Assessment, February 22, 2001. Page 32 of 36 APPENDIX A: EQUATIONS AND DEFNITIONS FOR CALCULATING MOES Page 33 of 36 Daily Exposure: Daily dermal or inhalation handler exposures are estimated for each applicable handler task with the application rate, quantity treated/ handled in a day, and the applicable dermal or inhalation unit exposure using the following formula:

Daily Exposure: E = UE x AR x AT ( Eq. 1)

Where: E = Amount ( mg ai/ day) deposited on the surface of the skin that is available for dermal absorption or amount inhaled that is available for inhalation absorption; UE = Unit exposure value ( mg ai/ lb ai) derived from August 1998 PHED data or from 1992 CMA data; AR = Maximum application rate based on a logical unit treatment, such as acres ( A), square feet ( sq. ft.), gallons ( gal), or cubic feet ( cu. ft). Maximum values are generally used ( lb ai/ A, lb ai/ sq ft, lb ai/ gal, lb ai/ cu ft); and AT = Normalized application area based on a logical unit treatment such as acres ( A/ day), square feet ( sq ft/ day), gallons ( gal/ day), or cubic feet ( cu ft/ day).

Daily Dose: The daily dermal or inhalation dose is calculated by normalizing the daily exposure by body weight and adjusting, if necessary, with an appropriate absorption factor. An absorption factor of 100% was used for both dermal and inhalation exposures. Daily dose was calculated using the following formula:

Daily Dose: ADD = E x ABS ( Eq. 2) BW Where: ADD = Absorbed dose received from exposure to a chemical in a given scenario ( mg active ingredient/ kg body weight/ day); E = Amount ( mg ai/ day) deposited on the surface of the skin that is available for dermal absorption or amount inhaled that is available for inhalation absorption; ABS = A measure of the amount of chemical that crosses a biological boundary such as lungs (% of the total available absorbed); and BW = Body weight determined to represent the population of interest in a risk assessment ( kg).

Margins of Exposure: Non cancer inhalation and dermal risks for each applicable handler scenario are calculated using a Margin of Exposure ( MOE), which is a ratio of the daily dose to the toxicological endpoint of concern.

Margins of Exposure: MOE = NOAEL or LOAEL ( Eq. 3) ADD Where: MOE = Margin of exposure, value used to represent risk or how close a chemical exposure is to being a concern ( unitless); NOAEL or LOAEL = Dose level in a toxicity study, where no observed adverse effects ( NOAEL) or where the lowest observed adverse effects ( LOAEL) occurred in the study; and ADD = Average daily dose or the absorbed dose received from exposure to a chemical in a given scenario ( mg ai/ kg body weight/ day). Page 34 of 36 APPENDIX B: Summary of CMA and PHED Data Page 35 of 36 The scenarios were assessed by using unit exposure data to estimate occupational handlers' exposures. Unit exposures are estimates of the amount of exposure to an active ingredient a handler receives while performing various handler tasks and are expressed in terms of micrograms or milligrams ( 1mg = 1,000 µ g) of active ingredient per pounds of active ingredient handled. A series of unit exposures have been developed that are unique for each scenario typically considered in assessments ( i. e., there are different unit exposures for different types of application equipment, job functions, and levels of protection). The unit exposure concept has been established in the scientific literature and also through various exposure monitoring guidelines published by the USEPA and international organizations such as Health Canada and OECD ( Organization for Economic Cooperation and Development).

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 AApplicator Exposure Monitoring@ in Subdivision U and the AOccupational 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 ( USEPA, 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 Asurrogate 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 either/ or field fortification, laboratory recoveries, and storage stability information.   Data have an insufficient amount of replicates.

The Pesticide Handlers Exposure Database ( PHED): 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 Page 36 of 36 been the Agency= s policy to use Asurrogate@ or Ageneric@ 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 mm Hg.] 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.


[Federal Register Volume 85, Number 90 (Friday, May 8, 2020)]
[Notices]
[Page 27409]
[FR Doc No: 2020-09868]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER20-1747-000]

 South Fork Wind, LLC; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced South Fork
Wind, LLC's application for market-based rate authority, with an
accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is May 25, 2020.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://ferc.gov) using the
eLibrary link. Enter the docket number excluding the last three digits
in the docket number field to access the document. At this time, the
Commission has suspended access to the Commission's Public Reference
Room, due to the proclamation declaring a National Emergency concerning
the Novel Coronavirus Disease (COVID-19), issued by the President on
March 13, 2020. For assistance, contact the Federal Energy Regulatory
Commission at<EMAIL_ADDRESS>or call toll-free, (886) 208-
3676 or TYY,<PHONE_NUMBER>.

    Dated: May 4, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-09868 Filed 5-7-20; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 96 (Thursday, May 17, 2012)]
[Proposed Rules]
[Pages 29250-29251]
[FR Doc No: 2012-11988]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

Federal Register / Vol. 77, No. 96 / Thursday, May 17, 2012 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 16

[Docket No. FAA-2012-0176]
RIN 2120-AJ97

Rules of Practice for Federally-Assisted Airport Enforcement
Proceedings (Retrospective Regulatory Review); Reopening of Comment
Period

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM); Reopening of comment
period.

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

SUMMARY: This action reopens the comment period for an NPRM that was
published on March 5, 2012. In that document, the FAA proposed to
update, simplify, and streamline rules of practice and procedure for
filing and adjudicating complaints against federally-assisted airports.
The Airports Council International-North America (ACI-NA), an
association representing the local, regional and state governing bodies
that own and operate the principal airports served by scheduled air
carriers in North America, has requested additional time to complete
its review and coordinate comments received from members that would be
impacted by the proposed changes.

DATES: The comment period for the NPRM published on March 5, 2012 (77
FR 13027) closed May 4, 2012, and is reopened until June 7, 2012.

ADDRESSES: You may send comments identified by docket number FAA-2012-
0176 using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE., Room
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: The FAA will post all comments it receives, without
change, to http://www.regulations.gov, including any personal
information the commenter provides. Using the search function of the
docket Web site, anyone can find and read the electronic form of all
comments received into any FAA docket, including the name of the
individual sending the comment (or signing the comment for an
association, business, labor union, etc.). DOT's complete Privacy Act
Statement can be found in the Federal Register published on April 11,
2000 (65 FR 19477-19478), as well as at http://DocketsInfo.dot.gov.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to Docket Operations in Room W12-140 of
the West Building Ground Floor at 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Melissa Loughlin, ARM-204, Office of
Rulemaking, Federal Aviation Administration, 800 Independence Avenue
SW., Washington, DC 20591, telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: See the ``Additional Information'' section
for information on how to comment on this proposal and how the FAA will
handle comments received. The ``Additional Information'' section also
contains related information about the docket, privacy, the handling of
proprietary or confidential business information. In addition, there is
information on obtaining copies of related rulemaking documents.

Background

    On March 5, 2012, the FAA issued Notice No. 12-02, entitled ``Rules
of Practice for Federally-Assisted Airport Enforcement Proceedings
(Retrospective Regulatory Review)'' (77 FR 13027). The FAA requested
that comments on that proposal be received on or before May 4, 2012.
    By petition dated May 4, 2012, ACI-NA, an association representing
the local, regional and state governing bodies that own and operate the
principal airports served by scheduled air carriers in North America,
requested that the FAA extend the comment period for Notice No. 12-02
for three weeks. The petitioner stated that additional time would allow
it to coordinate comments with representative airports, and contribute
to meaningful input on the proposed rule.

Reopening of Comment Period

    The FAA has reviewed the request made by ACI-NA for additional time
to comment on Notice No. 12-02. The petitioner has shown a substantive
interest in the proposed rule and good cause for the additional time to
comment. The FAA has determined that reopening the comment period is
consistent with the public interest, and that good cause exists for
taking this action.
    Accordingly, the comment period for Notice No. 12-02 is reopened
until June 7, 2012.

Additional Information

A. Comments Invited

    The FAA invites interested persons to participate in this
rulemaking by submitting written comments, data, or views. The agency
also invites comments relating to the economic, environmental, energy,
or federalism impacts that might result from adopting the proposals in
this document. The most helpful comments reference a specific portion
of the proposal, explain the reason for any recommended change, and
include supporting data. To ensure the docket does not contain
duplicate comments, commenters should send only one copy of written
comments, or if comments are filed electronically, commenters should
submit only one time.
    The FAA will file in the docket all comments it receives, as well
as a report summarizing each substantive public contact with FAA
personnel concerning this proposed rulemaking. Before acting on this
proposal, the FAA will consider all comments it receives on or before
the

closing date for comments. The FAA will consider comments filed after
the comment period has closed if it is possible to do so without
incurring expense or delay. The agency may change this proposal in
light of the comments it receives.

B. Availability of Rulemaking Documents

    An electronic copy of rulemaking documents may be obtained from the
Internet by--
    1. Searching the Federal eRulemaking Portal (http://www.regulations.gov);
    2. Visiting the FAA's Regulations and Policies Web page at http://www.faa.gov/regulations_policies or
    3. Accessing the Government Printing Office's Web page at http://www.gpo.gov/fdsys/.
    Copies may also be obtained by sending a request to the Federal
Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence
Avenue SW., Washington, DC 20591, or by calling<PHONE_NUMBER>.
Commenters must identify the docket or notice number of this
rulemaking.
    All documents the FAA considered in developing this proposed rule,
including economic analyses and technical reports, may be accessed from
the Internet through the Federal eRulemaking Portal referenced in item
(1) above.

    Issued in Washington, DC, on May 11, 2012.
Lirio Liu,
Acting Director, Office of Rulemaking.
[FR Doc. 2012-11988 Filed 5-16-12; 8:45 am]
BILLING CODE 4910-13-P


Comment Info: =================

General Comment:Plasma methylphenidate levels in youths with attention deficit hyperactivity disorder treated with OROS formulation.


[Federal Register Volume 87, Number 160 (Friday, August 19, 2022)]
[Notices]
[Pages 51086-51087]
[FR Doc No: 2022-17905]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC22-103-000.
    Applicants: Sonny Solar, LLC, PGR 2021 Lessee 13, LLC.
    Description: Joint Application for Authorization Under Section 203
of the Federal Power Act of Sonny Solar, LLC, et al.
    Filed Date: 8/12/22.
    Accession Number: 20220812-5217.
    Comment Date: 5 p.m. ET 9/2/22.

    Docket Numbers: EC22-104-000.
    Applicants: Allora Solar, LLC, PGR 2021 Lessee 19, LLC.
    Description: Joint Application for Authorization Under Section 203
of the Federal Power Act of Allora Solar, LLC, LLC, et al.
    Filed Date: 8/12/22.
    Accession Number: 20220812-5219.
    Comment Date: 5 p.m. ET 9/2/22.

    Docket Numbers: EC22-105-000.
    Applicants: Gunsight Solar, LLC, PGR 2021 Lessee 15, LLC.
    Description: Joint Application for Authorization Under Section 203
of the Federal Power Act of Gunsight Solar, LLC, et al.
    Filed Date: 8/12/22.
    Accession Number: 20220812-5222.
    Comment Date: 5 p.m. ET 9/2/22.

    Docket Numbers: EC22-106-000.
    Applicants: Cabin Creek Solar, LLC, PGR 2021 Lessee 12, LLC.
    Description: Joint Application for Authorization Under Section 203
of the Federal Power Act of Cabin Creek Solar, LLC, et al.
    Filed Date: 8/12/22.
    Accession Number: 20220812-5224.
    Comment Date: 5 p.m. ET 9/2/22.

    Docket Numbers: EC22-107-000.
    Applicants: Bulldog Solar, LLC, PGR 2021 Lessee 9, LLC.
    Description: Joint Application for Authorization Under Section 203
of the Federal Power Act of Bulldog Solar, LLC, et al.
    Filed Date: 8/12/22.
    Accession Number: 20220812-5227.
    Comment Date: 5 p.m. ET 9/2/22.
    Docket Numbers: EC22-108-000.
    Applicants: Northern States Power Company, a Minnesota Corporation,
Northern Wind Energy Redevelopment, LLC.
    Description: Joint Application for Authorization Under Section 203
of the Federal Power Act of Northern States Power Company, et al.
    Filed Date: 8/15/22.
    Accession Number: 20220815-5113.
    Comment Date: 5 p.m. ET 9/6/22.

    Docket Numbers: EC22-109-000.
    Applicants: Northern States Power Company, a Minnesota Corporation,
Rock Aetna Power Partners, LLC.
    Description: Joint Application for Authorization Under Section 203
of the Federal Power Act of Northern States Power Company, a Minnesota
Corporation, et al.
    Filed Date: 8/15/22.
    Accession Number: 20220815-5124.
    Comment Date: 5 p.m. ET 9/6/22.

    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER21-2455-003.
    Applicants: California Independent System Operator Corporation.
    Description: Compliance filing: 2022-08-15 Compliance Filing--FERC
Order No. 2222 to be effective 6/16/2022.
    Filed Date: 8/15/22.
    Accession Number: 20220815-5078.
    Comment Date: 5 p.m. ET 9/6/22.

    Docket Numbers: ER22-2494-000.
    Applicants: FirstEnergy Service Company.
    Description: FirstEnergy Service Company Submits Request for
Limited Waiver of Affiliate Rules.
    Filed Date: 7/25/22.
    Accession Number: 20220725-5180.
    Comment Date: 5 p.m. ET 8/19/22.

    Docket Numbers: ER22-2656-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original ISA/ICSA Nos. 6555
and 6556; Queue No. AC1-086 to be effective 7/14/2022.
    Filed Date: 8/15/22.
    Accession Number: 20220815-5036.
    Comment Date: 5 p.m. ET 9/6/22.

    Docket Numbers: ER22-2657-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Cost Responsibility
Agreement, SA No. 6557; Non-Queue No. NQ-173 to be effective 7/19/2022.
    Filed Date: 8/15/22.
    Accession Number: 20220815-5080.
    Comment Date: 5 p.m. ET 9/6/22.

    Docket Numbers: ER22-2659-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2022-08-15_SA 2927 Duke
Energy-Duke Energy 2nd Rev GIA (J453 J1189) to be effective 8/5/2022.
    Filed Date: 8/15/22.
    Accession Number: 20220815-5131.
    Comment Date: 5 p.m. ET 9/6/22.

    Docket Numbers: ER22-2660-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: SPS Formula Rate Revisions
to Incorporate Changes Accepted in ER22-201 to be effective 5/19/2021.
    Filed Date: 8/15/22.
    Accession Number: 20220815-5151.
    Comment Date: 5 p.m. ET 9/6/22.

    Docket Numbers: ER22-2661-000.
    Applicants: California Independent System Operator Corporation
    Description: Sec.  205(d) Rate Filing: 2022-08-15 Flexible Ramping
Product Enhancements to be effective 12/31/9998.
    Filed Date: 8/15/22.
    Accession Number: 20220815-5159.
    Comment Date: 5 p.m. ET 9/6/22.

    Docket Numbers: ER22-2662-000.
    Applicants: Aron Energy Prepay 14 LLC.
    Description: Baseline eTariff Filing: Market-Based Rate Application
to be effective 10/15/2022.
    Filed Date: 8/15/22.
    Accession Number: 20220815-5167.
    Comment Date: 5 p.m. ET 9/6/22.

    Take notice that the Commission received the following qualifying
facility filings:

    Docket Numbers: QF22-854-000.
    Applicants: Radford University.
    Description: Form 556 of Radford University.
    Filed Date: 8/15/22.
    Accession Number: 20220815-5033.
    Comment Date: 5 p.m. ET 9/6/22.
    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: August 15, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-17905 Filed 8-18-22; 8:45 am]
BILLING CODE 6717-01-P