Page 1 of 17 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, DC 20460 OFFICE OF PREVENTION, PESTICIDES, AND TOXIC SUBSTANCES March 23, 2006 MEMORANDUM SUBJECT: Residential Exposure Inert 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 Cassi Walls, Ph. D., Chemist, Team III 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: 327733 Case No.: 4006 Chemical Name ( s) CAS # 1 PC CODE1 Sodium dodecylbenzene sulfonate 25155 30 0 790102 Benzenesulfonic acid, C10 16 alkyl derivatives 68584 22 5 790116 Dodecylbenzene sulfonic acid 27176 87 0 790101 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 Preliminary Risk Assessment. Page 2 of 17 RESIDENTIAL EXPOSURE INERT 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 17 Executive Summary/ Background Information:

This document is the Residential Inert Exposure Assessment for the Reregistration Eligibility Decision Document ( RED) for alkylbenzene sulfonates. The currently listed 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 formulated as inert ingredients in approximately 350 registered end use products, which are formulated as soluble concentrates, flowable concentrates, ready to use solutions, or water soluble packaging. The alkylbenzene sulfonate inerts function as a solvent, surfactant, dispersant, detergent, or wetting agent. Products that contain alkylbenzene sulfonates as an inert are designated for use in agricultural settings, food handling premises, medical premises, commercial/ institutional/ industrial settings, and residential settings. Specified use sites for the products include the following: indoor hard non porous surfaces ( e. g. floors, walls etc.), carpets, food contact surfaces ( glasses, dishes, silverware, countertops, etc.), agricultural tools and crops, lawns and turfs, fruits and vegetables ( post harvest), wood preservatives, materials preservatives, metalworking fluids, and pet products. This assessment evaluated representative high end residential exposure scenarios which include: applicators of ready to use liquid turf and garden products, applicators of ready to use liquid hard surface and carpet cleaners, applicators of pet products, and children's post application exposures to turf, hard surface, carpet, and pet products.

For this assessment, the CSFs were examined to determine appropriate formulation rates to use for each scenario evaluated. The percent formulations for most of the products that contain alkylbenzene sulfonates as an inert ingredient range from 0.01% to 5%. However, the majority of the labels in this range contain 2% alkylbenzene sulfonates. Therefore, the risks were assessed at 2% formulation, which represents the formulation that is most likely to be used, and at an appropriate high end formulation, which is dependent upon the product type. It should be noted that a few sanitizing products have inert levels as high as 30% and the highest concentration of alkylbenzene sulfonates are found in wood preservative products up to 65 %.

The durations and routes of exposure that were evaluated in this assessment include short term ( ST) inhalation exposure and short term incidental oral exposure to children. There is no evidence of systemic toxicity via the dermal route therefore, dermal assessments were not conducted. However, it should be noted that alkylbenzene sulfonates are considered to be dermal irritants in formulations generally greater than 20%. The toxicological endpoints used in this assessment are provided in Table 1. Page 4 of 17 Table 1. 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 5 of 17 Table 1. 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 The margins of exposures ( MOEs) that were calculated for the inert uses of alkylbenzene sulfonates in residential products ( i. e., turf/ garden, cleaning products, and pet products) are summarized in Table 2. The MOEs were calculated for each scenario at 2% formulation as well as, the appropriate high end representative rate. The target MOE for this assessment is 100.

Table 2. Summary of the Short Term MOEs for Alkylbenzene Sulfonates used as Inert Ingredients Page 6 of 17 Product Use Exposure Scenario MOE High end formulation MOE 2% formulation Applicator Low pressure handwand; MLAP 20,000 1.1 E+ 05 Applicator Hose end sprayer; MLAP 3,100 1.7 E+ 04 Applicator Backpack; MLAP 20,000 1.1 E+ 05 Ready to Use Liquid turf spot/ gardensa Applicator Sprinkling can; MLAP 63,000 3.4 E+ 05 Ready to Use Liquid, hard surface cleanerb Applicator Low pressure handwand; MLAP 1,000 4,100 Ready to Use Liquid, carpet cleanerc Applicator Low pressure handwand; MLAP 1,400 4,100 Pet productsd Applicator Handler inhalation exposure 87 1,000 Ready to Use Liquid Turf spot/ gardensa Postapplication Incidental ingestion: hand to mouth 4,600 25,000 Ready to Use Liquid, hard surface cleaner b Postapplication Incidental ingestion: hand to mouth 30 120 Ready to Use Liquid, carpet cleanerc Postapplication Incidental ingestion: hand to mouth 40 120 Pet productsd Postapplication Toddler incidental oral ingestion 106 1,300 a: representative high end % formulation for this use scenario = 11% b: representative high end % formulation for this use scenario = 8% c: representative high end % formulation for this use scenario = 6% d: representative high end % formulation for this use scenario = 24%

Inert Assessment of Alkylbenzene Sulfonates: Page 7 of 17 The U. S Environmental Protection Agency's ( USEPA) Pesticide Inert Risk Assessment Tool ( PiRat) was used to estimate applicator and post application exposures and risks from the use of alkylbenzene sulfonates as an inert ingredient in representative residential products. Background information and the downloadable executable file for PiRat can be found at http:// www. epa. gov/ opptintr/ exposure/ docs/ pirat. htm. Unless specified, all of PiRat's default values were used in each run. Although PiRat has a module that can estimate exposures to pet products, HED's screening level methodologies have changed since the development of PiRat therefore, PiRat was not used to evaluate the pet product exposures.

Based on the review of Confidential Statements of Formula ( CSFs), the exposures and risks were assessed at 2% formulation, which represents the formulation that is most likely to be used, and at an appropriate high end formulation, which is dependent upon the product type. The percent formulations that were selected as the high end representative are appropriately indicated in the footnotes of the summary tables presented below. It should be noted that even though alkylbenzene sulfonates are used in numerous types of residential and occupational products, only exposures from representative residential, high end scenarios were estimated in this assessment. There was no dermal assessment conducted because of the lack of a dermal toxicological endpoint. In addition, there were no post application inhalation risks anticipated because the vapor pressure of the sulfonates is extremely low, and thus an inhalation post application assessment was not conducted.

The following residential use sites were assumed to be the high end representative scenarios for inert uses of alkylbenzene sulfonates. These include: outdoor residential premises, indoor hard surfaces, indoor carpets, and pet products. For each of the use sites, applicator ( handler) inhalation exposure and toddler post application incidental ingestion exposure were assessed. The applicator exposures and risks are presented in Tables 3 and 4, while the oral ( incidental ingestion) exposures and risks are presented in Table 5. Page 8 of 17 Table 3. Applicator Short term Inhalation Exposures and MOEs for Alkylbenzene Sulfonates used as Inert Ingredients in Outdoor Products Product Use Application Method Area Treateda Inhalation Exposure @ 11% mg/ kg/ dayb Inhalation Exposure @ 2% b mg/ kg/ day Inhalation MOEc @ 11% Inhalation MOEc @ 2%

Low pressure handwand; MLAP 1000 ft2/ day ( spot) 7.07E 06 1.29E 06 2.00. E+ 04 1.1E+ 05 Hose end sprayer; MLAP 2x104 ft2/ day ( full broadcast) 4.48E 05 8.15E 06 3.10. E+ 03 1.7E+ 04 Backpack; MLAP 1000 ft2/ day ( spot) 7.07E 06 1.29E 06 2.00. E+ 04 1.1E+ 05 Ready to Use Liquid turf spot/ gardensd Sprinkling can; MLAP 1000 ft2/ day ( spot)

2.24E 06 4.07E 07 6.30. E+ 04 3.4E+ 05 a: Standard PiRat model input parameters, for complete model output, see Appendix A b: an application rate of 0.00015 lb product/ ft2 was assumed for all scenarios and the body weight = 70kg. c: MOEs = NOAEL / exposure, where inhalation NOAEL = 0.14 mg/ kg/ day and the target MOE = 100 d: percent formulation used = 11%

Table 4. Applicator Short term Inhalation Exposures and MOEs for Alkylbenzene Sulfonates used as Inert Ingredients in Indoor Products Product Use Application Method Amount Usedb Inhalation Exposure @ 8% or 6% mg/ kg/ dayc Inhalation Exposure @ 2% c mg/ kg/ day MOEd @ 8% or 6% MOEd @ 2%

Ready to Use Liquid, hard surface cleaner a, e Low pressure handwand; MLAP 0.5 gallons/ day 1.37x10 4 3.43E 05 1,000 4,100 Ready to Use Liquid, carpet cleaner a, f Low pressure handwand; MLAP 0.5 gallons/ day 1.03x10 4 3.43E 05 1,400 4,100 a: Crack and crevice was used as the representative scenario hard surface cleaners or carpet cleaners. b: Standard PiRat model input parameters, for complete model output, see Appendix B. c: An application rate of 8 lb/ gallon, which is the density of water, was assumed for all scenarios and the body weight = 70kg. d: MOEs = NOAEL / exposure, where inhalation NOAEL = 0.14 mg/ kg/ day and the target MOE = 100 e: % formulation used = 8% f: % formulation used = 6% Page 9 of 17 Table 5. Toddler Short term Post Application Incidental Oral Exposures and MOEs for Alkylbenzene Sulfonates when used as an inerta Product Use Route of Exposure Exposure @ 11%, 8% or 6% mg/ kg/ dayb Exposure @ 2%

mg/ kg/ day c MOEc @ 11%, 8% or 6% MOEc @ 2%

Ready to Use Liquid Turf spot/ gardensd Incidental ingestion: hand to mouth 1.08E 02 1.96E 03 4,600 25,000 Ready to Use Liquid, hard surface cleaner a, e Incidental ingestion: hand to mouth 1.67 0.42 30 120 Ready to Use Liquid, carpet cleanera, f Incidental ingestion: hand to mouth 1.26 0.42 40 120 a: The representative use sites assessed using PiRAT, For a complete model output, see Appendix C. b: The toddler body weight = 15kg c: MOEs = NOAEL / exposure where incidental oral NOAEL = 50 mg/ kg/ day. Target MOE = 100. d: % formulation used = 11% e: % formulation used = 8% f: % formulation used = 6%

As previously indicated, alkylbenzene sulfonates are also used as inerts in pet flea and tick products. Therefore applicator inhalation exposures as well as toddler incidental oral exposures were evaluated. Although PiRat has a module that can estimate exposures to pet products, it was not used since HED's screening level methodologies have changed since the development of PiRat. The most recent methodologies were utilized to assess exposure pet products residues. In addition, aerosol application was the methodology chosen as the representative worst case scenario for this assessment.

The following equation and assumptions were used to estimate dermal and inhalation residential applicator exposures to pet product residues:

Exposure = UE x AR x N / BW where, AR = Application rate ( lb ai/ can) UE = Unit exposure ( mg/ lb ai) N = Number of cans ( cans/ day) BW = Body weight ( kg)

All of the input parameters are defaults provided in HEDs Residential SOPs ( US EPA, 1997 and 2001). The 24% formulation was used as the representative high end scenario whereas, 2% formulation was used to represent scenarios that are most likely to occur. Table 6 provides the input parameters and resulting exposures and MOEs.

Table 6. Applicator Short term Exposures and MOEs for Alkylbenzene Suflonates used as Inert Ingredients in Aerosol Pet Flea and Tick Products Page 10 of 17 Exposure = UE x AR x N / BW Percent a. i. 24% 2%

Unit Exposure ( mg / lb ai) 1 UE 2.4 Application Rate ( lb ai/ can) 2 AR 0.0938 0.007819 Number of cans/ day 1 N 0.5 Percent Absorption 100%

Body weight ( kg) 1 BW 70 Daily Dose ( mg/ kg/ day) 1.61x10 3 0.000134 Inhalation NOAEL ( mg/ kg/ day) 0.14 Target MOE 100 MOE3 87 1,000 1 US EPA, 1997 and 2001 ( HED= s Residential SOPs) 2 6 oz/ can x % ai x 1gal/ 128oz x 8.34lb/ gal ( assuming density of water) 3 MOEs = NOAEL / exposure, where the NOAEL = 0.14 mg/ kg/ day The following equation and assumptions were used to estimate toddler incidental oral residential post application exposure to pet product residues:

Exposure = AR x T x SA x SE x FQ / BW where, AR = Application rate ( mg/ cm2 animal) T = Transfer fraction from treated pet (%) SA = Surface area of a child =

s hands ( cm2/ event) SE = Saliva extraction (%) FQ = Frequency of contact ( event/ day) BW = Body weight ( kg)

All of the input parameters are defaults provided in HEDs Residential SOPs ( US EPA, 1997 and 2001). The percent formulations of 24% and 2% were also used in this assessment. Table 7 provides the input parameters and resulting exposures and MOEs.

Table 7. Toddler Short term Post application Incidental Oral Exposure and MOE for Alkylbenzene Sulfonates when used as an Inert Ingredient in Aerosol Flea and Tick Pet Products Exposure = AR x T x SA x SE x FQ / BW Page 11 of 17 Percent a. i. 24% 2%

Application Rate ( mg/ cm2 of animal) 1 AR 3.554 0.296 Transferable Fraction2 T 20%

Surface area of a child= s hand ( cm2) 2 SA 20 Saliva Extraction2 SE 50%

Frequency ( events/ day) 3 FQ 1 Body weight ( kg) 2 BW 15 Daily Dose ( mg/ kg/ day) 0.4739 0.0395 Oral NOAEL ( mg/ kg/ day) 50 Target MOE 100 MOE4 106 1,300 1 3 oz x % ai/ 6000cm2 x 1gal/ 128oz x 8.34lb/ gal x 1kg/ 2.2lb x 1000g/ kg x 1000mg/ g where it was assumed that 2 of 6 oz spray container is applied to a 30 lb animal having a surface area of 6000cm2 2 US EPA, 1997 and 2001 ( HED= s Residential SOPs) 3 frequency was modified to reflect transferable residue assumptions which is based on a 5 minute heavy rubbing/ petting technique that would lead to significantly higher hand concentrations than would result from a single contact 4 MOE = NOAEL / exposure Page 12 of 17 Appendix A: PiRat Model Output for Inhalation Risks to Handlers Using Outdoor Products PiRat Handler Report for Formulation Type Emulsifiable Concentrate Functional Use: Surfactant ( surfactant, detergent) Toxicity Value: .14 Body Weight: 70.0 kg Weight Fraction: 0.110 Duration: Short Term Absorption Value: 100.0 % Page 13 of 17 PiRat Handler Report for Formulation Type Emulsifiable Concentrate Scenario # 1 Scenario # 2 Scenario # 3 Scenario # 4 Product Use: turf turf turf turf Application Method: low pressure handwand; MLAP hose end sprayer; MLAP backpack: MLAP sprinkling can; MLAP Dermal PDR ( mg/ kg/ day): N/ A N/ A N/ A N/ A Inhalation PDR ( mg/ kg/ day) 7.07E 06 4.48E 05 7.07E 06 2.24E 06 Dermal Unit Exposure ( mg/ lb): N/ A N/ A N/ A N/ A Inhalation Unit Exposure ( mg/ lb): 3.00E 02 Medium 80 reps 9.50E 03 Low 8 reps 3.00E 02 Low 11 reps 9.50E 03 Low 8 reps Application Rate: 1.50E 04* lb/ ft2 1.50E 04* lb/ ft2 1.50E 04* mg/ kg/ day 1.50E 04* lb/ ft2 Fraction Exposed: N/ A N/ A N/ A N/ A Amount used: 1000.00 ft2/ day ( spot) 2.00E+ 04 ft2/ day ( full broadcast) 1000.00 ft2/ day ( spot) 1000.00 ft2/ day ( spot)

Density ( lb/ gal): N/ A N/ A N/ A N/ A MOE: 20000 3100 20000 63000 Exposure Frequency ( yrs) N/ A N/ A N/ A N/ A Exposure Duration ( yrs) N/ A N/ A N/ A N/ A Averaging Time ( yrs) N/ A N/ A N/ A N/ A LADD N/ A N/ A N/ A N/ A Cancer Risk N/ A N/ A N/ A N/ A Dose Calculation: Scenario # 1 4 PDR=( UE* AR* WF* A)/ BW Assumptions: Scenario # 1 1,000 ft2/ day assumed to be equivalent to 5 gal/ day; SAC Policy 11 Scenario # 2 upper percentile lawn size ( SAC Policy 11)

Scenario # 3 1,000 ft2/ day assumed to be equivalent to 5 gal/ day; SAC Policy 11 Scenario # 4 assumed based on hose end; SOPs * Modified by user Page 14 of 17 Appendix B: PiRat Model Output for Inhalation Risks to Handlers Using Indoor Products Page 15 of 17 PiRat Handler Report for Formulation Type Soluble Concentrate Functional Use: Surfactant ( surfactant, sirfactant, detergent) Toxicity Value: .14 Body Weight: 70.0 kg Weight Fraction: 8.00E 02 ( hard surface), 6.00E 02 ( carpet) Duration: Short Term Absorption Value: 100.0 %

Scenario # 1 ( hard surface) Scenario # 2 ( carpet)

Product Use: crack & crevice crack & crevice Application Method: low pressure handwand; MLAP low pressure handwand; MLAP Dermal PDR ( mg/ kg/ day): N/ A N/ A Inhalation PDR ( mg/ kg/ day) 1.37E 04 1.03E 04 Dermal Unit Exposure ( mg/ lb): N/ A N/ A Inhalation Unit Exposure ( mg/ lb): 3.00E 02 Medium 80 reps 3.00E 02 Medium 80 reps Application Rate: 8.00* lb/ gal 8.00* lb/ gal Fraction Exposed: N/ A N/ A Amount used: 0.50 gal/ day 0.50 gal/ day Density ( lb/ gal): N/ A N/ A MOE: 1000 1400 Exposure Frequency ( yrs) N/ A N/ A Exposure Duration ( yrs) N/ A N/ A Averaging Time ( yrs) N/ A N/ A LADD N/ A N/ A Cancer Risk N/ A N/ A Dose Calculation: Scenario # 1 and 2 PDR=( UE* AR* WF* A)/ BW Assumptions: Scenario # 1 and 2 SAC Policy 11 * Modified by user Page 16 of 17 Appendix C: PiRat Model Output for Toddler Postapplication Incidental Oral Esposure to Outdoor and Indoor Products Page 17 of 17 PIRAT Post Application Report for Formulation Type Soluble Concentrate Functional Use: Surfactant ( surfactant, sirfactant, detergent) Toxicity Value: 50 Body Weight: 15 kg Weight Fraction: 0.110 ( turf), 8.00E 02 ( hard surface), 6.00E 02 ( carpet) Duration: Short Term Absorption Value: 100.00 %

Scenario # 1 ( turf) Scenario # 2 ( hard surface) Scenario # 3 ( carpet)

Product Use: turf crack & crevice crack & crevice Activity: hand to mouth transfer hand to mouth transfer of surface residues hand to mouth transfer of surface residues Population: toddlers ( 3 years) toddlers ( 3 years) toddlers ( 3 years)

PDR ( mg/ kg/ day) 1.08E 02 1.67 1.26 Ingestion Rate: 0.50 ( saliva extraction factor) 0.50 ( saliva extraction factor) 0.50 ( saliva extraction factor)

T ( or Tc) N/ A N/ A N/ A Application Rate: 1.50E 04* lb/ ft2 8.00* lb/ gal 8.00* lb/ gal Weight Fraction: 0.110 8.00E 02 6.00E 02 Fraction Exposed: 5.00E 02 0.10 5.00E 02 Surface Area ( cm2/ event): 20.00 20.00 20.00 Exposure Time ( hrs/ day): 2.00 4.00 8.00 Frequency ( ev/ hr) 20.00 20.00 20.00 Kp ( cm/ hr) N/ A N/ A N/ A Vp ( torr) N/ A N/ A N/ A Molecular Weight ( g/ mole) N/ A N/ A N/ A Room Volume ( m3) N/ A N/ A N/ A MOE: 4600 30 40 Exposure Frequency ( days/ yr) 0.00 0.00 0.00 Exposure Duration ( yrs) 0.00 0.00 0.00 Averaging Time ( yrs) 70.00 70.00 70.00 LADD ( mg/ kg/ day) N/ A N/ A N/ A Cancer Risk N/ A N/ A N/ A Density ( lbs/ gal) N/ A N/ A N/ A Body Wt ( postapp) ( kg) 15.00 15.00 15.00 Treated area N/ A 1000.00* 1000.00* Page 18 of 17 Dose Calculation: PDR={( AR/ TA)* WF* F* 4.54e5 mg/ lb* 1.08e 3 ft2/ cm2* SA* IgR* FQ* ET}/ BW* ABS * Modified by user


[Federal Register: January 8, 2008 (Volume 73, Number 5)]
[Notices]
[Page 1395-1397]
[DOCID:fr08ja08-102]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2007-0017]

Qualification of Drivers; Exemption Applications; Vision

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of final disposition.

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SUMMARY: FMCSA announces its decision to exempt 28 individuals from the
vision requirement in the Federal Motor Carrier Safety Regulations
(FMCSRs). The exemptions will enable these individuals to operate
commercial motor vehicles (CMVs) in interstate commerce without meeting
the prescribed vision standard. The Agency has concluded that granting
these exemptions will provide a level of safety that is equivalent to,
or greater than, the level of safety maintained without the exemptions
for these CMV drivers.

DATES: The exemptions are effective January 8, 2008. The exemptions
expire on January 8, 2010.

FOR FURTHER INFORMATION CONTACT: Dr. Mary D. Gunnels, Director, Medical
Programs,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA, Department of
Transportation, 1200 New Jersey Avenue, SE., Room W64-224, Washington,
DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m. Monday through
Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Electronic Access

    You may see all the comments online through the Federal Document
Management System (FDMS) at http://www.regulations.gov.

    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140

on the ground level of the West Building, 1200 New Jersey Avenue, SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The FDMS is available 24 hours each day, 365
days each year. If you want acknowledgment that we received your
comments, please include a self-addressed, stamped envelope or postcard
or print the acknowledgement page that appears after submitting
comments on-line.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, etc.).
You may review the DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000 (65 FR 19477-78; Apr. 11, 2000).
This information is also available at http://Docketinfo.dot.gov.

Background

    On November 28, 2007, FMCSA published a notice of receipt of
exemption applications from certain individuals, and requested comments
from the public (72 FR 67341). That notice listed 28 applicants' case
histories. The 28 individuals applied for exemptions from the vision
requirement in 49 CFR 391.41(b)(10), for drivers who operate CMVs in
interstate commerce.
    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
for a 2-year period if it finds ``such exemption would likely achieve a
level of safety that is equivalent to, or greater than, the level that
would be achieved absent such exemption.'' The statute also allows the
Agency to renew exemptions at the end of the 2-year period.
Accordingly, FMCSA has evaluated the 28 applications on their merits
and made a determination to grant exemptions to all of them. The
comment period closed on December 28, 2007.

Vision and Driving Experience of the Applicants

    The vision requirement in the FMCSRs provides:
    A person is physically qualified to drive a commercial motor
vehicle if that person has distant visual acuity of at least 20/40
(Snellen) in each eye without corrective lenses or visual acuity
separately corrected to 20/40 (Snellen) or better with corrective
lenses, distant binocular acuity of a least 20/40 (Snellen) in both
eyes with or without corrective lenses, field of vision of at least 70
[deg] in the horizontal meridian in each eye, and the ability to
recognize the colors of traffic signals and devices showing standard
red, green, and amber (49 CFR 391.41(b)(10)).
    FMCSA recognizes that some drivers do not meet the vision standard,
but have adapted their driving to accommodate their vision limitation
and demonstrated their ability to drive safely. The 28 exemption
applicants listed in this notice are in this category. They are unable
to meet the vision standard in one eye for various reasons, including
amblyopia, retinal detachment, macular scar, macular degeneration,
cataract, retinal scar, alternating exotropia, and loss of vision due
to trauma. In most cases, their eye conditions were not recently
developed. All but seven of the applicants were either born with their
vision impairments or have had them since childhood. The seven
individuals who sustained their vision conditions as adults have had
them for periods ranging from 4 to 25 years.
    Although each applicant has one eye which does not meet the vision
standard in 49 CFR 391.41(b)(10), each has at least 20/40 corrected
vision in the other eye, and in a doctor's opinion, has sufficient
vision to perform all the tasks necessary to operate a CMV. Doctors'
opinions are supported by the applicants' possession of valid
commercial driver's licenses (CDLs) or non-CDLs to operate CMVs. Before
issuing CDLs, States subject drivers to knowledge and skills tests
designed to evaluate their qualifications to operate a CMV. All these
applicants satisfied the testing standards for their State of
residence. By meeting State licensing requirements, the applicants
demonstrated their ability to operate a commercial vehicle, with their
limited vision, to the satisfaction of the State.
    While possessing a valid CDL or non-CDL, these 28 drivers have been
authorized to drive a CMV in intrastate commerce, even though their
vision disqualified them from driving in interstate commerce. They have
driven CMVs with their limited vision for careers ranging from 3 to 42
years. In the past 3 years, four of the drivers had convictions for
traffic violations and three of them were involved in crashes.
    The qualifications, experience, and medical condition of each
applicant were stated and discussed in detail in the November 28, 2007
notice (72 FR 67341).

Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the vision standard in 49 CFR 391.41(b)(10) if the exemption is
likely to achieve an equivalent or greater level of safety than would
be achieved without the exemption. Without the exemption, applicants
will continue to be restricted to intrastate driving. With the
exemption, applicants can drive in interstate commerce. Thus, our
analysis focuses on whether an equal or greater level of safety is
likely to be achieved by permitting each of these drivers to drive in
interstate commerce as opposed to restricting him or her to driving in
intrastate commerce.
    To evaluate the effect of these exemptions on safety, FMCSA
considered not only the medical reports about the applicants' vision,
but also

their driving records and experience with the vision deficiency. To
qualify for an exemption from the vision standard, FMCSA requires a
person to present verifiable evidence that he/she has driven a
commercial vehicle safely with the vision deficiency for the past 3
years. Recent driving performance is especially important in evaluating
future safety, according to several research studies designed to
correlate past and future driving performance. Results of these studies
support the principle that the best predictor of future performance by
a driver is his/her past record of crashes and traffic violations.
Copies of the studies may be found at docket number FMCSA-98-3637.
    We believe we can properly apply the principle to monocular
drivers, because data from the Federal Highway Administration's (FHWA)
former waiver study program clearly demonstrate the driving performance
of experienced monocular drivers in the program is better than that of
all CMV drivers collectively. (See 61 FR 13338, 13345, March 26, 1996).
The fact that experienced monocular drivers demonstrated safe driving
records in the waiver program supports a conclusion that other
monocular drivers, meeting the same qualifying conditions as those
required by the waiver program, are also likely to have adapted to
their vision deficiency and will continue to operate safely.
    The first major research correlating past and future performance
was done in England by Greenwood and Yule in 1920. Subsequent studies,
building on that model, concluded that crash rates for the same
individual exposed to certain risks for two different time periods vary
only slightly. (See Bates and Neyman, University of California
Publications in Statistics, April 1952.) Other studies demonstrated
theories of predicting crash proneness from crash history coupled with
other factors. These factors--such as age, sex, geographic location,
mileage driven and conviction history--are used every day by insurance
companies and motor vehicle bureaus to predict the probability of an
individual experiencing future crashes. (See Weber, Donald C.,
``Accident Rate Potential: An Application of Multiple Regression
Analysis of a Poisson Process,'' Journal of American Statistical
Association, June 1971) A 1964 California Driver Record Study prepared
by the California Department of Motor Vehicles concluded that the best
overall crash predictor for both concurrent and nonconcurrent events is
the number of single convictions. This study used 3 consecutive years
of data, comparing the experiences of drivers in the first 2 years with
their experiences in the final year.
    Applying principles from these studies to the past 3-year record of
the 28 applicants, three of the applicants had a traffic violation for
speeding, one of the applicants had a traffic violation for passing in
a wrong lane, and three applicants were involved in crashes. The
applicants achieved this record of safety while driving with their
vision impairment, demonstrating the likelihood that they have adapted
their driving skills to accommodate their condition. As the applicants'
ample driving histories with their vision deficiencies are good
predictors of future performance, FMCSA concludes their ability to
drive safely can be projected into the future.
    We believe the applicants' intrastate driving experience and
history provide an adequate basis for predicting their ability to drive
safely in interstate commerce. Intrastate driving, like interstate
operations, involves substantial driving on highways on the interstate
system and on other roads built to interstate standards. Moreover,
driving in congested urban areas exposes the driver to more pedestrian
and vehicular traffic than exists on interstate highways. Faster
reaction to traffic and traffic signals is generally required because
distances between them are more compact. These conditions tax visual
capacity and driver response just as intensely as interstate driving
conditions. The veteran drivers in this proceeding have operated CMVs
safely under those conditions for at least 3 years, most for much
longer. Their experience and driving records lead us to believe that
each applicant is capable of operating in interstate commerce as safely
as he/she has been performing in intrastate commerce. Consequently,
FMCSA finds that exempting these applicants from the vision standard in
49 CFR 391.41(b)(10) is likely to achieve a level of safety equal to
that existing without the exemption. For this reason, the Agency is
granting the exemptions for the 2-year period allowed by 49 U.S.C.
31136(e) and 31315 to the 28 applicants listed in the notice of
November 28, 2007 (72 FR 67341).
    We recognize that the vision of an applicant may change and affect
his/her ability to operate a CMV as safely as in the past. As a
condition of the exemption, therefore, FMCSA will impose requirements
on the 28 individuals consistent with the grandfathering provisions
applied to drivers who participated in the Agency's vision waiver
program.
    Those requirements are found at 49 CFR 391.64(b) and include the
following: (1) That each individual be physically examined every year
(a) by an ophthalmologist or optometrist who attests that the vision in
the better eye continues to meet the standard in 49 CFR 391.41(b)(10),
and (b) by a medical examiner who attests that the individual is
otherwise physically qualified under 49 CFR 391.41; (2) that each
individual provide a copy of the ophthalmologist's or optometrist's
report to the medical examiner at the time of the annual medical
examination; and (3) that each individual provide a copy of the annual
medical certification to the employer for retention in the driver's
qualification file, or keep a copy in his/her driver's qualification
file if he/she is self-employed. The driver must also have a copy of
the certification when driving, for presentation to a duly authorized
Federal, State, or local enforcement official.

Discussion of Comments

    FMCSA received two comments in this proceeding. The comments were
considered and discussed below.
    Advocates for Highway and Auto Safety (Advocates) expressed
opposition to FMCSA's policy to grant exemptions from the FMCSRs,
including the driver qualification standards. Specifically, Advocates:
(1) Objects to the manner in which FMCSA presents driver information to
the public and makes safety determinations; (2) objects to the Agency's
reliance on conclusions drawn from the vision waiver program; (3)
claims the Agency has misinterpreted statutory language on the granting
of exemptions (49 U.S.C. 31136(e) and 31315); and finally (4) suggests
that a 1999 Supreme Court decision affects the legal validity of vision
exemptions.
    The issues raised by Advocates were addressed at length in 64 FR
51568 (September 23, 1999), 64 FR 66962 (November 30, 1999), 64 FR
69586 (December 13, 1999), 65 FR 159 (January 3, 2000), 65 FR 57230
(September 21, 2000), and 66 FR 13825 (March 7, 2001). We will not
address these points again here, but refer interested parties to those
earlier discussions.
    One individual opposes the granting of vision exemptions to vision
impaired drivers. She believes that granting vision exemptions to
drivers makes the roads more dangerous. This individual also believes
that the Agency's policies are too lax.
    In regard to this comment, the discussion under the heading,
``Basis for Exemption Determination,'' explains in detail the
evaluation methods the Agency utilizes prior to granting an

exemption to ensure that the granting of an exemption is likely to
achieve an equivalent or greater level of safety than would be achieved
without the exemption. To evaluate the effect of these exemptions on
safety, FMCSA considered not only the medical reports about the
applicants' vision, but also their driving records and experience with
the vision deficiency. To qualify for an exemption from the vision
standard, FMCSA requires a person to present verifiable evidence that
he or she has driven a commercial vehicle safely with the vision
deficiency for 3 years. Recent driving performance is especially
important in evaluating future safety, according to several research
studies designed to correlate past and future driving performance.
Results of these studies support the principle that the best predictor
of future performance by a driver is his/her past record of crashes and
traffic violations. Copies of the studies may be found at docket number
FMCSA-98-3637.

Conclusion

    Based upon its evaluation of the 28 exemption applications, FMCSA
exempts Thomas E. Anderson, Garry A. Baker, Richard D. Becotte, Timothy
W. Bickford, James E. Blazer, Terry S. Brookshire, Jr., Wayne A.
Burnett, Theodore W. Cozat, Zibbie L. Dawsey, Alex G. Dlugolenski,
Karen Y. Duvall, Gordon R. Fritz, John A. Graham, Jimmy D. Gregory,
Taras G. Hamilton, Larry K. Lentz, Boleslaw Makowski, Joseph W.
Meacham, Charles M. Moore, Anthony D. Ovitt, John R. Parsons, III,
Steven S. Reinsvold, Michael J. Richard, Glenn T. Riley, George E.
Todd, Gary S. Warren, Bradley A. Weiser, and Eddie L. Williams, from
the vision requirement in 49 CFR 391.41(b)(10), subject to the
requirements cited above (49 CFR 391.64(b)).
    In accordance with 49 U.S.C. 31136(e) and 31315, each exemption
will be valid for 2 years unless revoked earlier by FMCSA. The
exemption will be revoked if: (1) The person fails to comply with the
terms and conditions of the exemption; (2) the exemption has resulted
in a lower level of safety than was maintained before it was granted;
or (3) continuation of the exemption would not be consistent with the
goals and objectives of 49 U.S.C. 31136 and 31315.
    If the exemption is still effective at the end of the 2-year
period, the person may apply to FMCSA for a renewal under procedures in
effect at that time.

    Issued on: December 31, 2007.
Larry W. Minor,
Associate Administrator for Policy and Program Development.
[FR Doc. E8-106 Filed 1-7-08; 8:45 am]

BILLING CODE 4910-EX-P


[Federal Register Volume 81, Number 1 (Monday, January 4, 2016)]
[Notices]
[Page 118]
[FR Doc No: 2015-33029]

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SECURITIES AND EXCHANGE COMMISSION

[File No. 500-1]

In the Matter of Changda International Holdings, Inc.: Order of
Suspension of Trading

December 29, 2015.
    It appears to the Securities and Exchange Commission
(``Commission'') that there is a lack of current and accurate
information concerning the securities of Changda International
Holdings, Inc. (``CIHD \1\'') (CIK No. 1417624), a revoked Nevada
corporation whose principal place of business is listed as Weifang,
Shandong, China because it is delinquent in its periodic filings with
the Commission, having not filed any periodic reports since it filed a
Form 10-Q for the period ended June 30, 2012. On April 28, 2015, the
Commission's Division of Corporation Finance sent a delinquency letter
to CIHD at the address shown in its then-most recent filing in the
Commission's EDGAR system requesting compliance with its periodic
filing requirements, . To date, CIHD has failed to cure its
delinquencies. As of December 15, 2015, the common stock of CIHD was
quoted on OTC Link operated by OTC Markets Group, Inc. (formerly ``Pink
Sheets'') had seven market makers and was eligible for the
``piggyback'' exception of Exchange Act Rule 15c2-11(f)(3).
---------------------------------------------------------------------------

    \1\ The short form of the issuer's name is also its ticker
symbol.
---------------------------------------------------------------------------

    The Commission is of the opinion that the public interest and the
protection of investors require a suspension of trading in the
securities of the above-listed company. Therefore, it is ordered,
pursuant to Section 12(k) of the Securities Exchange Act of 1934, that
trading in the securities of the above-listed company is suspended for
the period from 9:30 a.m. EST on December 29, 2015, through 11:59 p.m.
EST on January 12, 2016.

    By the Commission.
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2015-33029 Filed 12-31-15; 8:45 am]
 BILLING CODE 8011-01-P