Applying Dusts via Shaker Can 100 From label, apply 1 lb/ 50 ft2 for flea control on carpets AR = 1 lb/ 50ft2 0.02 lb ai/ ft2 256c ft2/ day 800 1677 191 Granular Bait Dispersed by Hand 54 Used 1.51 g/ mL as density = 2.51 lb ai/ gal; assume apply ½ container ( 6 oz) AR = ( 1.51 g/ mL)*( 1000 mL/ L)*( 3.785 L/ gal)*( 1 kg/ 1000 g)*( 2.2 lb/ 1 kg)*( 54/ 100)*( 0.0078 gal/ oz)* 6 oz 0.32 lb ai/ day NA NA 2,400 SODIUM TETRABORATE DECAHYDRATE 48369 2 Mixing/ Loading/

Applying Dusts via Shaker Can 100 From label:

package is 1 lb;

assume use ½ ( 0.5 lb) and since percent a. i. is 100,

assume 0.5 lb a. i. AR = 0.5 lb ai/ day 0.5 lb ai/ day NA NA 13,000 SODIUM TETRABORATE PENTAHYDRATE 5185 461 Loading/ Applying Granulars via Spoon or Cup 100 From label, apply 4.5 lbs/ 1000 gal;

assume treat 20,000 gal/ day AR = ( 4.5 lb/ 1000 gal) 0.0045 lb ai/ gal 20000 gal/ day 1,000 5185 492 Applying Ready to Use Formulations via Pour on 100 From label, apply 10 oz/ 200 gal;

assume treat 200 gal/ day AR = ( 10 oz)*( 0.0625 lb/ 1 oz)/( 200 gal) 0.0031 lb ai/ gal 200 gal/ day 5,600,000 Table 6.3a Residential Handler Inhalation Risks Due to Exposure to Boric Acid and its Sodium Salts as Active Ingredients Registration Number Exposure Scenario Percent active ingredient Assumptions for estimating product application rate Calculations of product application rate ( AR) Application Rate Units Area Treated or Amount Handled Dailya Units Baseline Inhalation MOEb Page 46 of 86 SODIUM TETRAHYDRATE 1083 1 Applying Ready to Use Formulations via Trigger Pump Sprayer 0.28 Use density ( 2.56 g/ mL) to determine lb ai/ gal; assume apply 1 pint of solution ( 0.125 gal/ day) AR = ( 2.56 g/ mL)*( 1000 mL/ L)*( 3.785 L/ gal)*( 1 kg/ 1000 g)*( 2.2 lb/ kg)*( 0.28/ 100) 0.06 lb ai/ gal 0.125 gal/ day 3,100,000 DISODIUM OCTABORATE 71653 5 Mixing/ Loading/

Applying Emulsifiable Concentrates with a Paint Brush 18.12 Use density ( 1.8 g/ mL) to determine lb ai/ gal; assume apply 1 liter of solution ( 0.264 gal/ day) AR = ( 1.8 g/ mL)(* 1000 mL/ L)*( 3.785 L/ gal)*( 1 kg/ 1000 g)(* 2.2 lb/ kg)*( 18.12/ 100) 2.72 lb ai/ gal 0.264 gal/ day 12,000 DISODIUM OCTABORATE TETRAHYDRATE 64405 6 Applying Ready to Use Formulations via Trigger Pump Sprayer 8.5 Use density ( 0.32 g/ mL) to determine lb ai/ gal;

assume apply 1 gal/ day AR = ( 0.32 g/ mL)*( 1000 mL/ L)*( 3.785 L/ gal)*( 1 kg/ 1000 g)*( 2.2 lb/ kg)*( 8.5/ 100) 0.23 lb ai/ gal 1 gal/ day 110,000 79628 1 Mixing/ Loading/

Applying Emulsifiable Concentrates with a Paint Brush 99.98 From label, apply 1 lb/ gallon solution;

apply 10 gallons/ day NA 1 lb ai/ gal 10 gal/ day 1,000 79628 1 Mixing/ Loading/ Ap plying Emulsifiable Concentrates with Low Pressure Handwand 99.98 From label, apply 1 lb/ gallon solution;

apply 10 gallons/ day NA 1 lb ai/ gal 10 gal/ day 9,700 79628 1 Applying Ready to Use Formulations via Trigger Pump Sprayer 99.98 From label, apply 1 lb/ gallon solution;

apply 10 gallons/ day NA 1 lb ai/ gal 10 gal/ day 2,400 Page 47 of 86 a Amount handled per day values are either determined from the product label or are EPA estimates of amount treated based on revised Residential SOPs ( 2/ 01). b Baseline Inhalation MOE = NOAEL ( 8.8 mg boron/ kg day) / adjusted inhalation daily dose ( mg/ kg day), where adjusted inhalation dose =[ daily unit exposure ( µ g/ lb ai) x application rate x amount handled per day x conversion factor ( if needed) / body weight ( 70 kg adult)] * percent boron. c Assume area of average household room = 256 ft2.

Residential handler exposures to consumer use ( non pesticidal) products containing boric acid and sodium borate salts are shown below in Table 6.3b. The Consumer Exposure Module ( CEM) ( Versar, 1999) was used to determine the lifetime average daily dose ( LADD), average daily dose ( ADD) and acute potential daily dose rate ( ADR). The CEM is similar to the Agency's MCCEM ( multiple chamber concentration and exposure model). A link providing additional details on CEM is found at: http:// www. epa. gov/ opptintr/ exposure/ docs/ efastman. pdf. Two sodium salts of boric acid are known to be ingredients in consumer use products: sodium tetraborate decahydrate in laundry detergent and general purpose cleaners and sodium tetraborate in laundry detergent. The exposure scenarios examined were the use of a general purpose cleaner, assuming a weight fraction range of 7% to 13%, and laundry detergent, assuming a weight fraction range of 1% to 5%. Table 6.3b provides the CEM inhalation MOE estimates. Exposure output information from the CEM model is provided in Appendix 4.0. Using the oral NOAEL of 8.8 mg boron/ kg day and assuming 100% inhalation absorption, the inhalation MOEs ranged from 400,000 for a general purpose cleaner containing sodium tetraborate decahydrate to 13,000,000 for a laundry detergent containing sodium tetraborate. A MOE of 16,000 was obtained for general purpose cleaner with boric acid as an inert ingredient.

Table 6.3b Summary of Consumer Inhalation Exposure Scenario Weight Fractions Years of Use Surface Area/ Body Weight Ratio ( cm2/ kg) Frequency of Use ( events/ yr) Acute Dose Rate ( mg/ kg day) Percent boron (%) Adjusted Acute Dose Rate ( mg/ kg day) Inhalation MOEa SODIUM TETRABORATE DECAHYDRATE ( Active ingredient)

General Purpose Cleaner 0.07 0.13 57 15.6 300 1.91e 04 11.34 2.2e 05 400,000 Laundry Detergent 0.01 0.05 57 15.6 312 5.96e 06 11.34 6.8e 07 13,000,000 SODIUM TETRABORATE ( Active ingredient)

Laundry Detergent 0.01 0.05 57 15.6 312 3.23e 06 21.49 6.9e 07 13,000,000 BORIC ACID ( Inert Ingredient)

General 0.15 57 15.6 300 3.1e 03 17.5 5.0e 04 16,000 Page 48 of 86 Purpose Cleaner a MOE = NOAEL ( 8.8 mg boron/ kg day)/ Adjusted Acute Dose Rate <IP_ADDRESS> Residential Postapplication Exposure Scenarios  Swimming Pool Incidental Oral Postapplication incidental oral exposure to adults and children may be anticipated from swallowing swimming pool water. Exposure characterization of postapplication exposure to adult and children swimmers is shown below in Table 6.3c. Two products containing sodium tetraborate pentahydrate may be applied to both swimming pools and spas. In order to assess exposures, the SWIMODEL ( Version 2.0) Swimming Screening Tool was used ( Versar, 2001). Oral exposure routes were examined for adults and children. The daily exposures were compared to the oral NOAEL of 8.8 mg boron/ kg day to estimate a level of risk ( MOE) for both adults and children ( assessed separately for ages 7 10 and 11 14). Table 6.3c provides the SWIMODEL oral and inhalation MOE estimates. Exposure output information from the SWIMODEL is provided in Appendix 6.0. The MOEs for incidental oral exposure were 42 for children 7 10 and 68 for children age 11 14 for products containing sodium tetraborate pentahydrate, but were 44,000 for products containing boric acid; the MOE for adults exposed to sodium tetraborate pentahydrate as the active ingredient was 420 ( not calculated for boric acid based on high MOEs in children).

Table 6.3c. Postapplication Exposure to Swimmers Scenario Exposed Swimmer Chemical concentration in water ( µ g/ L) ADDa ( mg/ kg/ day) Percent boron Adjusted ADD ( mg/ kg/ day) MOEb SODIUM TETRABORATE PENTAHYDRATE ( Active ingredient)

Oral exposure Adult non competitive male 54,000 0.14 14.85 0.021 420 Child ( 7 10) non competitive 1.43 14.85 0.212 42 Child ( 11 14) non competitive 0.87 14.85 0.129 68 BORIC ACID ( Inert Ingredient)

Oral exposure Child ( 7 10) non competitive 538 0.0014 17.5 0.0002 44,000 Child ( 11 14) non competitive 0.00087 17.5 0.0002 44,000 a Oral exposure ADD ( mg/ kg/ day) = ( Cw or Chemical concentration in water, µ g/ L)( Exposure time, hr/ event)*( Ingestion rate, L/ hr)*( Exposure frequency, events/ hr)*( Exposure duration, hrs)*( conversion factor, mg/ µ g)/( Body weight, kg). b NOAEL of 8.8 mg boron/ kg day was used. Note: Adult MOE not shown for boric acid as an inert since Children MOEs are above 40,000. Page 49 of 86 <IP_ADDRESS> Residential Postapplication Exposure Scenarios  Children Hand to Mouth Transfer Postapplication incidental oral exposure to boric acid and its sodium salts in dust and ready to use liquid pesticide products via hand to mouth transfer in young children is anticipated to occur from contact with treated indoor surfaces, such as carpets and hard surfaces. Although the endpoint selected is for all durations, a short term exposure assessment was conducted for children because it is the more conservative assessment. Short term assessment uses higher percentile ( 90th) values ( 20 per hour) for the frequency of hand to mouth events than for longer term exposures ( mean 9.5 events per hour). Exposure and risk assessment for these scenarios is presented below in Table 6.3d. In order to estimate the risk to children, application rates were calculated in terms of pounds of active ingredient applied per square foot, based either on product label information or assumptions of application areas. For those dust formulations applied to cracks and crevices ( i. e., around floorboards or under appliances), it was assumed that only 50% of the applied product would be available and of that, only 5% would be dislodgeable. Other assumptions made in the calculations of dose are provided in Table 6.3d, including surface area, number of events, exposure time, and body weight. MOEs ranged from 1 for a dust formulation applied to carpets to 55 for a ready to use flea spray applied to carpets. Page 50 of 86 Table 6.3d. Summary of Representative Postapplication Exposure to Children  Hand to Mouth Transfer from Indoor Surfaces Formulation Application Rate ( lb ai/ sq ft) Percent available Percent active ingredient dislodgeable Surface area ( cm2) Hand to Mouth ( events/ hr) Extraction by Saliva Exposure Time ( hours) Body Weight ( kg) Surface Residue ( µ g/ cm2) e Average Daily Dose ( mg/ kg day) f % Boron Average Daily Dose ( equivalent) g MOEh BORIC ACID ( Active Ingredient)

Dust Carpet 0.02 100% 5% 20 20 50% 8 15 9,806 52.30 17.5 9.16 1 Dust Carpet a 0.01 50% 5% 20 20 50% 8 15 5,061 13.50 17.5 2.36 4 SODIUM TETRABORATE DECAHYDRATE ( Active Ingredient)

Dust Carpet a 0.02 50% 5% 20 20 50% 8 15 9,806 26.15 11.3 2.95 3 DISODIUM OCTABORATE TETRAHYDRATE ( Active Ingredient)

Spray Carpet b 0.0003 100% 5% 20 20 50% 8 15 147 0.78 21.0 0.16 55 Spray Carpet c 0.001 100% 5% 20 20 50% 8 15 490 2.61 21.0 0.54 16 DISODIUM OCTABORATE ( Active Ingredient)

Spray Carpet d 0.01 100% 5% 20 20 50% 8 15 4,903 26.15 25.0 6.54 1 a For granular bait, assumed crack and crevice scenario  assumed room size = 256 ft2 and that only spread product around edges of walls, 0.5 ft wide swath therefore application area = 31 ft2; also assume only 50% of the product is available for exposure.

b From label, apply 0.23 lb ai/ gallon to 750 ft2.

c From label, apply 1 lb ai/ gallon to 1000 ft2.

d From label, apply 1L/ 5 m2 = 0.005 gal/ ft2.

e Surface residue ( µ g/ cm2) = application rate ( lb ai/ sq ft) * ( conversion factor lb/ µ g) * ( conversion factor sq ft/ sq cm).

f Average daily dose ( mg/ kg day) = ( Surface residue * percent active ingredient dislodgeable * surface area * Hand to mouth events * percent extraction by saliva * exposure time)/ body weight.

g Average daily dose ( equivalent) = average daily dose * percent boron.

h MOE = NOAEL ( 8.8 mg boron/ kg day)/ average daily dose ( equivalent). Page 51 of 86 <IP_ADDRESS> Residential Handler Exposure Inerts Inert uses were also identified for boric acid and its sodium salts. One of the uses is in pesticide formulations applied to agricultural crops. The labels for these products specify the use of personal protective equipment and these products were not examined as part of this assessment. Another inert use identified was application of tablets or pellets to swimming pools. Two products were identified, one containing 1% boric acid and one containing 0.5% sodium metaborate. This type of scenario had been examined with products containing 100% of sodium tetraborate pentahydrate as the active ingredient. It was assumed that the handler MOEs from use of products containing either boric acid or sodium metaborate as inert ingredients would be much greater than the use of a product containing 100% of sodium tetraborate pentahydrate. However, since the oral MOEs for children exposed through swimming were below the target MOE of 100 for sodium tetraborate pentahydrate, those scenarios were re examined using the information available for boric acid. The same application rate was assumed and a correction was made for the 1% weight fraction of boric acid in the product. The MOEs for both child exposure scenarios ( 7 10 years and 11 14 years) were above the target MOE ( see Table 6.3c). Since the MOE for the children 11 14 years was 44,000, an adult male assessment was not performed since their exposure would be lower. The third inert use identified was in consumer products, such as general purpose cleaners, which contain boric acid as an inert ingredient ( weight fraction = 15%). It was expected that the MOE would be rather small, considering the results from the examination of general purpose cleaners containing sodium tetraborate decahydrate as an active ingredient. The CEM model was run for boric acid and the inhalation MOE was calculated to be 16,000 ( see Table 6.3a). CEM model outputs are shown in Appendix 5.0.

<IP_ADDRESS> Residential Risk Characterization Uncertainties Associated With Residential Postapplication Exposures Certain postapplication exposure scenarios resulted in MOEs that were less than the target MOE of 100. The MOEs for residential postapplication exposure to dust and spray formulations from hand to mouth activities of young children ranged from 1 to 55 and the oral MOEs for residential postapplication exposure to swimming pools ranged from 42 to 420. Several factors need to be considered when interpreting these MOEs, including:

( 1) For the swimming pool exposure scenarios there is uncertainty associated with the assumption that the pesticide applied will not dissipate.

( 2) For the dust formulations applied as crack and crevice treatments, the area treated is based on an assumption of the size of an average room and that the area treated would be a small swath of carpet along the edges of the room. Most of the product labels recommend that the products be applied liberally to cracks and crevices to make sure that Page 52 of 86 no powder is left visible on indoor surfaces. In the assessment it was assumed that the powder was not removed. If the residues were removed by wiping or vacuuming, the MOE would likely be greater than 100.

( 3) Many of the labels state that children should not be present during application of pesticide products. This would reduce the likelihood of exposure of young children to pesticide residues through hand to mouth behavior, although such exposure could occur post application.

( 4) For liquid products applied directly to carpets, use of a hand transfer efficiency of 5 percent for the hand to mouth pathway is likely to overestimate exposure for the oral route. In a draft letter regarding dislodgeable, disodium octaborate tetrahydrate ( DOT) residues measured with a California roller, transfer efficiencies reported ranged from 0.04 to 0.09 percent. A discussion of the study is presented in Krieger et al., 1996; Human Disodium Octaborate Tetrahydrate Exposure Following Carpet Flea Treatment is Not Associated with Significant Dermal Absorption. Several residue collection devices are available to investigators. In a round robin comparison of indoor residue collection methods, it was suggested that the California roller had similar transfer efficiency as the polyurethane foam roller ( UF). In subsequent testing, the transfer efficiency of the UF roller was also compared to the efficiency of wet hands. ORD determined that the transfer efficiency of wet hands was 1.5 to 3 times higher than the UF roller. The highest percent ( 5) is used in the screening level assessment performed in this assessment. It is likely that the 5 percent transfer efficiency assumption used in the hand to mouth assessment for DOT overestimates the exposure and risk. However, since the DOT findings are reported in a draft letter, and the round robin testing did not include any measurements of DOT, it is recommended that confirmatory hand press data be collected by the registrants to refine the hand to mouth exposure estimates for carpets treated with forms of boric acid.

6.3.2 Other ( Spray Drift, etc.)

Spray drift is always a potential source of exposure to residents nearby to spraying operations. This is particularly the case with aerial application ( there are currently no aerial applications for boric acid or sodium borate salts), but, to a lesser extent, could also be a potential source of exposure from the ground application method employed for boric acid and sodium borate salts. The Agency has been working with the Spray Drift Task Force, EPA Regional Offices and State Lead Agencies for pesticide regulation and other parties to develop the best spray drift management practices. On a chemical by chemical basis, the Agency is now requiring interim mitigation measures for aerial applications that must be placed on product labels/ labeling. The Agency has completed its evaluation of the new data base submitted by the Spray Drift Task Force, a membership of U. S. pesticide registrants, and is developing a policy on how to Page 53 of 86 appropriately apply the data and the AgDRIFT computer model to its risk assessments for pesticides applied by air, orchard airblast and ground hydraulic methods. After the policy is in place, the Agency may impose further refinements in spray drift management practices to reduce off target drift with specific products with significant risks associated with drift.

7.0 Aggregate Risk Assessments and Risk Characterization Aggregate exposure assessments were not performed for boric acid and sodium borate salts. This decision was based on several considerations as discussed below.

An assessment of dietary exposure was not conducted. Boron is a naturally occurring component of food and water and may be a necessary nutrient at trace levels, although no minimum daily requirement has been established. Boric acid and sodium borate salts are exempt from tolerances and therefore residue data were not submitted for the food/ feed uses. The exemption was granted based on the natural occurrence of boron in the diet and on limited residue data ( citrus and cottonseed, submitted to support earlier tolerances that were later revoked) indicating that pesticide residues from these applications would not contribute significantly to total dietary boron. In fact, the levels of boron in commodities treated post harvest ( not a currently registered use) with boric acid were virtually indistinguishable to the levels of boron occurring naturally in untreated commodities. Boric acid and its sodium salts are also used as inert ingredients ( at much smaller concentrations than when used as an active ingredient) in both food and non food use pesticide products. A tolerance exemption for use in products applied to growing crops is currently established.

It is noted that there may be considerable variability in boron consumption from natural dietary sources, depending on the type of diet consumed and natural variations in drinking water levels. In general, vegetarian diets would provide a higher daily intake than omnivorous diets. Some dietary supplements may also contain trace levels of boron. Estimates of daily boron intake vary, ranging in the United States from 0.26 to 7.1 mg/ day with a mean of 1.9 mg/ day ( 0.03 mg/ kg/ day)( Moore, 1997). Other survey data provide average daily dietary boron intake values of 0.5 to 3.1 mg/ day ( 0.007 to 0.044 mg/ kg/ day)( Nielsen, 1991). The FDA determined an average U. S. adult male dietary boron intake of 1.52 mg/ day ( 0.025 mg/ kg/ day)( Iyengar et al., 1988). Dietary exposure to boron is therefore unlikely to exceed the level of concern in most circumstances and the contribution from residues of boric acid/ sodium borate salt pesticides to these levels should not result in a significant increase. It should also be noted that the dose selected as the NOAEL ( 8.8 mg/ kg/ day in dogs) for use in the risk assessment was based on boric acid/ sodium borate added to the animals' diets and did not include background boron intake from naturally occurring levels in the basal diet and drinking water: the actual dietary intake of boron ( and therefore the total boron dose) would be expected to be somewhat higher than 8.8 mg/ kg/ day when the naturally occurring boron levels in the basal diet and drinking water for these Page 54 of 86 animals were added. However, background dietary boron exposure information for the animal studies was unavailable.

Post application exposures to children from two residential uses exceeded the level of concern. Incidental oral exposure from swallowing treated swimming pool water and from handto mouth ingestion of carpet dust treatment in children showed MOEs that were well below 100. Therefore, the exposures to children from these uses filled the risk cup. Therefore, even though the MOEs for residential handlers/ applicators were not of concern (> 36,000); an aggregate exposure is not conducted when risks ( in this case from post application exposures to children) exceed the level of concern.

The Agency also considered exposures from non pesticidal sources of boron ( found in laundry detergent and general purpose cleaners) as well as from inerts in pesticidal products. Inhalation exposures to consumer products containing boric acid or borax were below the level of concern ( MOEs $ 5200). Residential postapplication incidental oral exposure to swimming pool treatment products containing boric acid as an inert rather than an active ingredient also did not exceed the level of concern for either children or adults ( MOEs$ 44,000). Based on the large MOEs for these exposure scenarios, they would not be a significant source of boron internal dosing and would not contribute significantly to total daily boron exposure compared to the diet.

8.0 Cumulative Risk Characterization/ Assessment Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to boric acid and its sodium salts and any other substances and boric acid/ sodium salts do not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that boric acid/ sodium salts have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at http:// www. epa. gov/ pesticides/ cumulative/.

9.0 Occupational Exposure/ Risk Pathway Characterization of nonresidential occupational exposure and risk are not required at this time because this assessment is for a tolerance reassessment only.

10.0 Data Needs and Label Requirements Page 55 of 86 10.1 Toxicology A rat 28 day inhalation study on boric acid is required at this time to better characterize risk from inhalation exposure, based on the available acute inhalation data ( Toxicity Category II) and the potential for inhalation exposure from registered uses.

10.2 Residue Chemistry Boric acid and its salts are currently exempt from tolerances. Tolerances on citrus ( 8 ppm) and cottonseed ( 30 ppm) were revoked upon granting of the exemption. Except for citrus and cottonseed, studies on the magnitude of boron residues have not been submitted for boric acid and sodium borate salts because of the tolerance exemption. However, due to the large number of crops to which these active ingredients may be applied, the Agency is requiring submission of magnitude of residue data on several representative crops as confirmatory data to verify that there is not a significant contribution of pesticide residues to total dietary boron intake. The crops to be tested will be determined following a review of the current uses.

10.3 Occupational and Residential Exposure Additional hand transfer data to better characterize postapplication exposures to young children resulting from hand to mouth ingestion resulting from crack/ crevice and carpet treatment are requested.

References:

MRID NUMBERS ( DATA SUBMISSIONS)

00005592 United States Borax & Chemical Corporation Toxicity Data for Boric acid Esters, Elemental Boron, and Other Borates. ( Unpublished study received Apr 9, 1958 under unknown admin. no.; CDL: 110723 A)

00006719 Hazleton Laboratories, Incorporated ( 1962) Toxicity of Borax and Boric Acid. Received Jun 25, 1969 under 1624 96; submitted by United States Borax & Chemical Corp., Los Angeles, Calif. Unpublished report.

00064208 Keller, J. G. ( 1962) Acute Oral Administration Dogs: Boric Acid. Received March 5, 1981 under 1624 117; prepared by Hazleton Laboratories, Inc., submitted by United States Borax & Chemical Corp., Los Angeles, CA. Unpublished report. Page 56 of 86 00064209 Estep, C. L. and Teske, R. H. ( 1968) Acute Application of Sample 713 123A to the Eyes of Rabbits: S 152A. Received Mar 5, 1981 under 1624 117; prepared by Hill Top Research, Inc., submitted by United States Borax & Chemical Corp., Los Angeles, Calif. Unpublished report.

00106011 Conine, D., Weiner, A., Kreuzmann, J. et al. ( 1982) Acute Dermal Toxicity Screen in Rabbits: Primary Skin Irritation Study in Rabbits of Boric Acid ( OA 107 3) for U. S. Borax Research Corporation: Hill Top Research Project No. 82 0280 21. Received Jul 12, 1982 under 1624 116; prepared by Hill Top Research, Inc., submitted by United States Borax & Chemical Corp., Los Angeles, CA. Unpublished report.

40692301 Meyding, G. D. ( 1961) Acute Oral Administration  Rats with Sodium Tetraborate Decahydrate. Hazleton Nuclear Science Corp., Palo Alto, CA. No study number provided. January 25, 1961. Unpublished report.

40692302 Meyding, G. D. ( 1961) Acute Oral Administration  Rats with Sodium Tetraborate Decahydrate. Hazleton Laboratories, Inc., Vienna, VA. No study number provided. August 2, 1961. Unpublished report.

40692303 Keller, J. G. ( 1962) Acute Oral Administration  Rats with Borax ( Sodium Tetraborate Decahydrate). Hazleton Laboratories, Inc., Vienna, VA. No study number provided. March 16, 1962. Unpublished report.

40692304 Keller, J. G. ( 1962) Acute Oral Administration  Dogs with Borax ( Sodium Tetraborate Decahydrate). Hazleton Laboratories, Inc., Vienna, VA. No study number provided. March 16, 1962. Unpublished report.

40692305 Paynter, O. E. ( 1962) 90 Day Dietary Administration  Rats with 20 Mule Team Borax ( Sodium Tetraborate Decahydrate). Hazleton Laboratories, Inc., Falls Church, VA. No study no. provided, December 13, 1962. Unpublished report.

40692306 Weir, R. J. ( 1963) 90 Day Dietary Administration  Rats with 20 Mule Team Borax ( Sodium Tetraborate Decahydrate). Hazleton Laboratories Inc., Vienna, VA. No study number provided. February 15, 1963.

40692307 Paynter, O. E. ( 1963) 90 Day Dietary Feeding  Dogs with 20 Mule Team Borax ( Sodium Tetraborate Decahydrate). Hazleton Laboratories, Inc., Falls Church, VA. No study number provided, January 17, 1963. Unpublished report. Page 57 of 86 40692308 Weir, R. J. ( 1967) 38 Week Dietary Feeding  Dogs with 20 Mule Team Borax ( Sodium Tetraborate Decahydrate). Hazleton Laboratories, Inc., Falls Church, VA. No study number provided. February 28, 1967. Unpublished report.

40692309 Weir, R. J. and Crews, L. M. ( 1967) Two Year Dietary Administration  Albino Rats. Borax ( Sodium Tetraborate Decahydrate) and Addendum. Hazleton Laboratories, Inc., Falls Church, VA. Laboratory Project ID 182 104, April 10, 1967 ( original report on July 8, 1966). Unpublished report.

40692310 Weir, R. J. and Crews, L. M. ( 1967) Two Year Dietary Feeding  Dogs. Borax ( Sodium Tetraborate Decahydrate) and Addendum. Hazleton Laboratories, Inc., Falls Church, VA. Laboratory Project ID 182 106, April 10, 1967 ( original study on July 8, 1966). Unpublished report.

40692311 Weir, R. J. and Crews, L. M. ( 1966) Three Generation Reproductive Study  Rats with Borax ( Sodium Tetraborate Decahydrate) and Addendum. Hazleton Laboratories, Inc., Vienna, VA. Study No.: Project 182 105, July 8, 1966. Unpublished report.

41589101 Fail, George, Grizzle et al. ( 1990) Reproductive Toxicity of Boric Acid in CD 1 Swiss Mice. NTP, NIEHS, Research Triangle Park, N. C. Study Number 90 105, April 13, 1990. Unpublished report.

41725401 Field, E. A., Price, C. J., Marr, M. C. et al. ( 1990) Final Report on the Developmental Toxicity of Boric Acid ( CAS No. 10043 35 3) in Sprague Dawley Rats. EPA Reg. No. 1624 117. Research Triangle Institute and National Toxicology Program. Study Number Rt88 BORT, May 1, 1990. Published report.

41725402 Field, E. A., Price, C. J., Marr, M. C. et al. ( 1990) Final Report on the Developmental Toxicity of Boric Acid ( CAS No. 10043 35 3) in CD 1 Swiss Mice. EPA Reg. No. 1624 117. Research Triangle Institute and National Toxicology Program. Study Number M188 BORT, December 14, 1990. Published report.

41861301 Dieter, M., Bishop, J., Eustis, S. Haseman, J. et al. ( 1991) Toxicology and Carcinogenesis of Boric Acid in B6C3F1 Mice, NTP Technical Report Series 324. E. G. and G. Mason Research Institute, Study No. TR324, April, 1991. Published report. Page 58 of 86 42038901 Steward, K. R. ( 1991) Salmonella/ Microsome Plate Incorporation Assay of Boric Acid. SRI International, Inc., Menlo Park, CA. Study No. 2389 A200 91, August 12, 1991. Unpublished report.

42038902 Rudd, C. J. ( 1991) Mouse Lymphoma Cell Mutagenesis Assay ( tk+// tk/) of Boric Acid. SRI International, Menlo Park, CA. Study Number 2389 G300 91, August 23, 1991. Unpublished report.

42038903 Bakke, J. P. ( 1991) Evaluation of the Potential of Boric Acid to Induce Unscheduled DNA Synthesis in In Vitro Hepatocyte DNA Repair Assay Using the Male F 344 Rat. SRI International, Menlo Park, CA. Study Number 2389 V500 91, August 21, 1991. Unpublished report.

42038904 O'Loughlin, K. G. ( 1991) Bone Marrow Erythrocyte Micronucleus Assay of Boric Acid in Swiss Webster Mice. SRI International, Menlo Park, CA. Study Number 2389 C400 91, August 19, 1991. Unpublished report.

42164201 Price, C., Marr, M. and Myers, C. et al. ( 1991) Developmental Toxicity of Boric Acid in New Zealand White Rabbits. NTP and Chemistry and Life Sciences, Research Triangle Park, NC. Study No. Rb90 BPORA, October 30, 1991. Published report.

42164202 Price, C.; Marr, M. and Myers, C.; et al. ( 1991) Laboratory Supplement for Final Report on the Development Toxicity of Boric Acid in New Zealand White Rabbits. National Institute of Environmental Health Science and Research Triangle Institute, Lab Project Number: RB90 BORA. Unpublished report.

43340101 Price, C. J., Marr, M. C. and Myers, C. B. ( 1994) Determination of NOAEL for Developmental Toxicity in Sprague Dawley Rats Exposed to Boric Acid in Feed on Gestation Days 0 20 and Evaluation of Post Natal Recovery Through Post Natal Day 21. Reproduction and Developmental Toxicology Labs, RTI, RTP, North Carolina. Study Number 65C5657 200, August 8, 1994. Unpublished report.

43553201 Reagan, E. and Becci, P. ( 1985) Acute Dermal Toxicity Study of 20 Mule Team, Lot USB 11 84 Sodium Tetraborate Decahydrate in New Zealand White Rabbits. Food and Drug Research Laboratories, Inc., Waverly, NY. Study Report No. FDRL 8403A, February 20, 1985. Unpublished report.

43553202 Reagan, E. and Becci, P. ( 1985) Primary Eye Irritation Study of 20 Mule Team, Page 59 of 86 Lot USB 11 84 Sodium Tetraborate Decahydrate in New Zealand White Rabbits. Food and Drug Research Laboratories, Inc., Waverly, NY. Study Report No. FDRL 8403A, February 8, 1985. Unpublished report.

43553203 Reagan, E. and Becci, P. ( 1985) Primary Dermal Irritation Study of 20 Mule Team, Lot USB 11 84 Sodium Tetraborate Decahydrate in New Zealand White Rabbits. Food and Drug Research Laboratories, Inc., Waverly, NY. Study Report No. FDRL 8403A, January 23, 1985. Unpublished report.

HED/ EPA DOCUMENTS U. S. EPA. ( 1993) Reregistration Eligibility Decision ( RED): Boric Acid and its Sodium Salts. Office of Prevention, Pesticides, and Toxic Substances ( 7508W). EPA 738 R 93 017.

U. S. EPA. ( 2005) Guidelines for Carcinogen Risk Assessment. Risk Assessment Forum, U. S. EPA, March, 2005. EPA 630/ p 03/ 001F.

U. S. EPA IRIS ( 2004) Toxicological Review of Boron and Compounds. June, 2004, EPA 635/ 04/ 052 ( www. epa. gov/ iris).

U. S. EPA Science Advisory Council ( SAC) for Exposure ( 2001) Policy 12: Revised Residential SOP Assumptions ( February 22, 2001).

Versar, Inc. ( 1999) Consumer Exposure Module ( CEM), Version 1.2. Prepared for the Economics, Exposure and Technology Division of the Office of Pollution Prevention and Toxic Substances.

Versar, Inc. ( 2001) SWIMODEL, Version 2.0. Prepared for the Office of Pesticide Programs, Antimicrobial Division.

PUBLISHED CITATIONS Agency for Toxic Substances and Disease Registry ( ATSDR) ( 1992) Toxicological Profile for Boron and Compounds. U. S. Public Health Service.

Anderson, D. L., Cunningham, W. C. and Lindstrom, T. R. ( 1994) Concentrations and Intakes of H, B, S, K, Na, Cl and NaCl in Foods. Journal of Food Comp. and Anal. 7: 59 82. Page 60 of 86 Chapin, R. E. and Ku, W. W. ( 1994) The Reproductive Toxicity of Boric Acid. Environ. Health Perspect. 102( Suppl. 7): 87 91.

ECETOX European Centre for Ecotoxicology and Toxicology of Chemicals. ( 1995) Technical Report No. 63.

Fail, P. A., Chapin, R. E., Price, C. J. et al. ( 1998) General, Reproductive, Developmental and Endocrine Toxicity of Boronated Compounds. Reprod. Toxicol 12: 1 18.

Iyengar, G. V., Clarke, W. B., Downing, R. G. et al. ( 1988) Lithium in biological and dietary materials. Trace Elem. Anal. Chem. Med. Biol. 5: 267 269.

Ku, W. W. and Chapin. R. E. ( 1994) Mechanism of the Testicular Toxicity of Boric Acid in Rats. In Vivo and In Vitro Studies. Environ. Health Perspect. 102( Suppl. 7): 99 105.

Krieger, R. L.; Dinoff, T. M.; and Peterson, J.: ( 1996) Human Disodium Octaborate Tetrahydrate Exposure Following Carpet Flea Treatment is Not Associated with Significant Dermal Exposure. Journal of Exposure Analysis and Environmental Epidemiology, Vol. 6, No. 3, pp. 279 288.

Material Safety Data Sheet for 20 Mule Team ® Tim bor ® Industrial ( 1996) Ecological information providing percent of boron in disodium octaborate tetrahydrate. http:// www. bpbcorp. com/ boratesht. html Moore, J. A. ( 1997) An Assessment of Boric Acid and Borax Using the IEHR Evaluative Process for Assessing Human Developmental and Reproductive Toxicity of Agents. Expert Scientific Committee. Reprod. Toxicol. 11( 1): 123 160.

Murray, F. J. ( 1995) A Human Health Risk Assessment of Boron ( Boric Acid and Borax) in Drinking Water. Res. Tox. Pharm. 22: 221 230.

Naghii, M. R. and Samman, S. ( 1996) The boron content of Selected Foods and the Estimation of its Daily Intake Among Free Living Subjects. J. Am. College Nutr. 15( 6): 614 619.

Narotsky, M. G., Wery, N. and Hamby, B. T. et al. ( 2003) Effects of Boric Acid on Hox Gene Expression and the Axial Skeleton in the Developing Rat. In: Massaro, E. J and Rogers, J. M., eds. The Skeleton: Biochemical, Genetic and Molecular Interactions in Development and Homeostasis. Totowa, NJ, Humana Press.

National Academy of Sciences Dietary ( 2001) Reference Intakes Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium Page 61 of 86 and Zinc. 2001. Food and Nutrition Board, Institute of Medicine, p. 773.

National Institute for Occupational Safety and Health ( NIOSH). ( 2001) International Chemical Safety Cards ( ICSC): Boric Acid  0991; Sodium tetraborate decahydrate  0567; Sodium tetraborate  1229. http:// www. cdc. gov/ niosh/ npg/ npg. html Nielsen, F. H. ( 1991) Nutritional Requirements for Boron, Silicon, Vanadium, Nickel and Arsenic: Current Knowledge and Speculation. FASEB J. 5: 2661 2667.

Wery, N., Narotsky, M. G., Pacico, N. et al. ( 2003) Defects in Cervical Vertebrae in Boric Acid Exposed Rat Embryos are associated with Anterior Shifts of Hox Gene Expression Domains. Birth Defects Res. ( Part A) 67: 59 67.

World Health Organization ( WHO). ( 1998) Environmental Health Criteria 204: Boron. International Programme on Chemical Safety ( IPCS). Geneva, Switzerland. ISBN 92 4 157204 3. http:// www. inchem. org/ documents/ ehc/ ehc/ ehc204. htm Page 62 of 86 Appendices 1.0 TOXICOLOGY DATA REQUIREMENTS The requirements ( 40 CFR 158.340) for food and non food uses of boric acid and its sodium salts are presented below in Table 1. Use of the new guideline numbers does not imply that the new ( 1998) guideline protocols were used.

Test Technical Required Satisfied 870.1100 Acute Oral Toxicity . . . . . . . . . . . . . . . . . . . . . . . . . 870.1200 Acute Dermal Toxicity . . . . . . . . . . . . . . . . . . . . . . 870.1300 Acute Inhalation Toxicity . . . . . . . . . . . . . . . . . . . . 870.2400 Primary Eye Irritation . . . . . . . . . . . . . . . . . . . . . . . 870.2500 Primary Dermal Irritation . . . . . . . . . . . . . . . . . . . . 870.2600 Dermal Sensitization . . . . . . . . . . . . . . . . . . . . . . . . yes yes yes yes yes no yes yes yes yes yes

870.3100 Oral Subchronic ( rodent) . . . . . . . . . . . . . . . . . . . . . 870.3150 Oral Subchronic ( nonrodent) . . . . . . . . . . . . . . . . . . 870.3200 21 Day Dermal . . . . . . . . . . . . . . . . . . . . . . . . . . . . 870.3250 90 Day Dermal . . . . . . . . . . . . . . . . . . . . . . . . . . . . 870.3465 28 Day Inhalation . . . . . . . . . . . . . . . . . . . . . . . . . . yes yes no no yes yes yes

870.3700a Developmental Toxicity ( rodent) . . . . . . . . . . . . . . . 870.3700b Developmental Toxicity ( nonrodent) . . . . . . . . . . . . 870.3800 Reproduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . yes yes yes yes yes yes 870.4100a Chronic Toxicity ( rodent) . . . . . . . . . . . . . . . . . . . . 870.4100b Chronic Toxicity ( nonrodent) . . . . . . . . . . . . . . . . . 870.4200a Oncogenicity ( rat) . . . . . . . . . . . . . . . . . . . . . . . . . . 870.4200b Oncogenicity ( mouse) . . . . . . . . . . . . . . . . . . . . . . . 870.4300 Chronic/ Oncogenicity . . . . . . . . . . . . . . . . . . . . . . . yes yes yes yes yes yes yes yes yes yes 870.5100 Mutagenicity  Gene Mutation  bacterial . . . . . . . . 870.5300 Mutagenicity  Gene Mutation  mammalian . . . . . . 870.5xxx Mutagenicity  Structural Chromosomal Aberrations 870.5xxx Mutagenicity  Other Genotoxic Effects . . . . . . . . . . yes yes yes no yes yes yes

870.6100a Acute Delayed Neurotox. ( hen) . . . . . . . . . . . . . . . . 870.6100b 90 Day Neurotoxicity ( hen) . . . . . . . . . . . . . . . . . . . 870.6200a Acute Neurotox. Screening Battery ( rat) . . . . . . . . . 870.6200b 90 Day Neuro. Screening Battery ( rat) . . . . . . . . . . . 870.6300 Develop. Neuro . . . . . . . . . . . . . . . . . . . . . . . . . . . . no no no no no

870.7485 General Metabolism . . . . . . . . . . . . . . . . . . . . . . . . 870.7600 Dermal Penetration . . . . . . . . . . . . . . . . . . . . . . . . . no no   Test Technical Required Satisfied Page 63 of 86 Special Studies for Ocular Effects Acute Oral ( rat) . . . . . . . . . . . . . . . . . . . . . . . . . . . . Subchronic Oral ( rat) . . . . . . . . . . . . . . . . . . . . . . . . Six month Oral ( dog) . . . . . . . . . . . . . . . . . . . . . . . no no no

2.0 NON CRITICAL TOXICOLOGY STUDIES ( 1) In a subchronic oral toxicity study ( MRID 40692305), sodium tetraborate decahydrate ( borax technical, about 105% of theoretical) was administered to 10 Charles River Sprague Dawley rats/ sex/ dose in the diet at dose levels of 0, 0.0463%, 0.154%, 0.463%, 1.54% or 4.63% ( equivalent to an average daily intake of 0, 34, 113, 339, 1057 or 4610 mg/ kg/ day test material; 0, 4.0, 14, 42, 125 or 544 mg/ kg/ day boron equivalents) for 13 weeks.

At 0.0463%, testicular atrophy in 4/ 10 males was reported, with these animals also showing reduced testicular weights. However, since a dose response was not observed at 0.154% ( 0/ 10) and 0.463% ( 1/ 10), this was not considered a treatment related finding ( further supported by lack of testicular effects at these dose levels in another rat subchronic study, MRID 40692306, and a chronic rat study, MRID 40692309). The incidence of testicular atrophy at the low dose, together with a reduction in body weight gain in the early weeks of the study, but not after week 4 of the study, suggest a possible error in dosage or animal group mixup at the study start. At 1.54%, clinical signs of toxicity ( beginning during the first week of treatment and including rapid respiration, hunched posture, thinness, swollen paws, inflamed eyes, coarse fur/ desquamation; during the later weeks, protruding penis and shrunken scrotum in males and an unsteady gait in 3 females were observed; incidence for most signs not given in report), decreased body weight/ weight gain ( beginning in the first weeks of the study) in males ( 53%/ 67% at termination below controls) and females ( 19%/ 32% below controls at termination), decreased weekly food consumption ( on a g/ animal/ day basis reduced about 40 50% below controls) and testicular atrophy in 10/ 10 males was observed. Testicular and ovary weights were significantly reduced ( 77% and  42%, respectively); relative weights were also reduced ( by  54% and  32%, respectively). At 4.63%, all animals on study died between weeks 1 5 and were reported to be in poor condition, including rapid respiration, swollen paws, coarse fur, hunched position and unsure gait, bloody nasal discharge, inflamed eyes and emaciation. Histopathological examination was not performed on the high dose animals due to autolysis. The LOAEL is 1.54% ( 1057 mg/ kg/ day test material; 125 mg/ kg/ day boron equivalents), based on decreased body weight, clinical signs and testicular atrophy. The NOAEL is 0.463% ( 339 mg/ kg/ day test material; 42 mg/ kg/ day boron equivalents). Page 64 of 86 This 90 day oral toxicity study in the rat is classified as acceptable ( non guideline). Although the study was not conducted according to standard Agency guidelines ( lacking clinical chemistry and hematology data) and the data suggest a possible dosing error or group mixup in low dose males in the first weeks, the data, when taken together with a second 90 day study in the rat ( MRID 40692306) and a two year rat study ( MRID 40692309), are considered adequate for regulatory purposes and satisfy the guideline requirement for a 90 day oral toxicity study ( OPPTS 870.3100; OECD 408) in the rat. A new study is not required at this time.

( 2) In a subchronic oral toxicity study ( MRID 40692306), sodium tetraborate decahydrate ( borax technical, analyzed at about 105% of theoretical) was administered to 10 male Charles River Sprague Dawley rats/ dose in the diet at dose levels of 0, 0.0154%, 0.0463%, 0.154% or 0.463% ( equivalent to 0, 11.7, 35.5, 115 or 362 mg/ kg/ day test material; 0, 1.3, 4.3, 13.1 or 41 mg/ kg/ day boron equivalents) for 13 weeks. Clinical chemistries ( blood, urine), hematology and ophthalmologic evaluations were not performed.

There were no treatment related effects observed on clinical signs, mortality, body weight/ weight gain, food consumption, organ weights or gross/ microscopic pathology at any dose tested. The NOAEL for systemic toxicity in male rats is 0.463% ( 41 mg/ kg/ day elemental boron). A LOAEL was not determined in this study.

This 90 day oral toxicity study in the rat is classified as acceptable ( nonguideline). The study was conducted using only males and numerous parameters were not examined. It does not on its own satisfy the guideline requirement for a 90 day oral toxicity study ( OPPTS 870.3100; OECD 408) in the rat. However, it provides useful information to supplement a second 90 day rat subchronic study on borax ( MRID 40692306) and support selection of a subchronic NOAEL in the rat ( 42 mg/ kg/ day boron equivalents) and may be used for regulatory purposes.

( 3) In two independently performed reverse gene mutation assays ( MRID 42038901), Salmonella typhimurium strains TA 1535, 1536, 1638, 98 and 100 were exposed to boric acid ( tech., > 99% a. i.) at concentrations of 10 to 2500 µ g/ plate in the presence or absence of either 4% or 10% rat liver S9.

There was no evidence of either cytotoxicity or mutagenicity in any of the tested strains under these experimental conditions. The test material should have been tested up to 5000 µ g/ plate since it is sufficiently water soluble; however, the results were in good agreement with the published finding that boric acid, prepared in water up to 1820 µ g/ plate or in DMSO up to 10,000 µ g/ plate, was not cytotoxic or genotoxic in S. typhimurium. The positive controls induced the appropriate responses in the corresponding strains.

This study is classified as acceptable ( guideline) and satisfies the guideline requirement Page 65 of 86 for Test Guideline OPPTS 870.51001; OECD 471 for in vitro mutagenicity ( bacterial reverse gene mutation) data. for a gene mutation study in bacteria.

( 4) In a forward gene mutation assay in cultured mammalian cells ( MRID 42038902), mouse lymphoma L5178Y cells were treated with boric acid ( tech., > 99% a. i.) at concentrations from 1200 to 5000 µ g/ mL in the presence and absence of S9 activation.

Boric acid did not cause an increase in the frequency of mutant colonies under the experimental conditions. Doses of 5000 µ g/ mL  S9 and 3500 and 5000 µ g/ mL + S9 were marginally cytotoxic. The positive controls induced the appropriate responses in this assay.

This study is classified as acceptable ( guideline) and satisfies the guideline requirement for Test Guideline OPPTS 870.5300, OECD 476 for in vitro mutagenicity ( mammalian forward gene mutation) data.

( 5) In an unscheduled DNA synthesis assay in cultured primary rat hepatocytes ( MRID 42038903), cell cultures were incubated with boric acid ( tech., > 99% a. i.) at concentrations from 5 to 5000 µ g/ mL.

No definitive conclusions could be reached from the two independently performed primary rat hepatocyte UDS assays. Although the net nuclear grain counts from the test material were negative values, the extremely low background counts ( 12.6 and  15.7 net nuclear grain counts in Trials 1 and 2, respectively) for the solvent control cultures ( Williams Medium E) confounded interpretation of the findings. The study author claimed that the apparent increases in net nuclear grains and percentage of cells in repair was due to decreased cytoplasmic grain counts, which was considered to be due to cytotoxicity and not increased DNA repair. The positive control induced an increase in net nuclear grain counts and percent cells with $ 5 net nuclear counts in both trials.

This study is classified as unacceptable ( guideline) upgradable and does not satisfy the guideline requirement for Test Guideline OPPTS 870.5550; OECD 482/ 486 for other genotoxic mutagenicity data. The primary data ( cytoplasmic and gross nuclear grain counts) necessary to support the conclusions of the study author were not provided in the study report. The study may be upgraded to Acceptable ( guideline) upon submission of primary data and determination that it supports the conclusions of the study author.

( 6) In an in vivo mammalian cell micronucleus assay, boric acid ( tech., > 99% a. i.) was administered twice, separated by 24 hrs, by gavage in distilled water to 10 Swiss Webster mice/ sex/ dose at 0, 900, 1800 or 3500 mg/ kg. Animals ( 5/ sex/ dose) were sacrificed at 24 or 48 hrs following the second dosing. There were no signs of toxicity observed during the study and no evidence of cytotoxicity Page 66 of 86 to the target organ. Boric acid was tested at an adequate dose based on the combined dose over 24 hrs ( 7000 mg/ kg) exceeding the limit dose of 5000 mg/ kg for this assay ( daily dose of 3500 mg/ kg/ day was limited by physical properties of the test material). The positive control induced the appropriate response. There was not a significant increase in the frequency of micronucleated polychromatic erythrocytes in bone marrow after any treatment time.

This study is classified as acceptable ( guideline) and satisfies the guideline requirement for Test Guideline OPPTS 870.5395; OECD 474 for in vivo cytogenetic mutagenicity data. Page 67 of 86 3.0 ACTIVE INGREDIENT RESIDENTIAL HANDLER EXPOSURE Residential Handler Inhalation Risks Exposure Scenario Application Rate Application Rate Units Area Treated Daily Units Inhalation Unit Exposure ( µ g/ lb ai) Inhalation Exposurea ( mg/ day) Inhalation Doseb ( mg/ kgday % boron Inhalation Doseequivalentc ( mg/ kg day) Inhalation MOEd Mixer/ Loader/ Applicator BORIC ACID Mixing/ Loading/ Applying Dusts via Shaker Can 0.02 lb ai/ ft2 256 ft2/ day 870 4.5 0.064 17.5 0.011 36,000 Applying Ready to Use Formulations with Aerosol Cans 0.27 lb ai/ day 1 NA 2400 0.65 0.0093 17.5 0.0016 250,000 Granular Bait Dispersed by Hand 0.32 lb ai/ day 1 NA 467 0.15 0.0021 17.5 0.00037 1,100,000 SODIUM TETRABORATE DECAHYDRATE Mixing/ Loading/ Applying Dusts via Shaker Can 0.5 lb ai/ day 1 NA 870 0.44 0.0062 11.34 0.0007 570,000 SODIUM TETRABORATE PENTAHYDRATE Loading/ Applying Granulars via Spoon or Cup 0.0045 lb ai/ gallon 20,000 gallons 45 4.1 0.058 14.85 0.0086 47,000 Applying Ready to Use Formulations via Pour on ( using PHED liquid mixer/ loader data) 0.0031 lb ai/ gallon 200 gallons 1.2 0.00074 0.000011 14.85 0.0000016 250,000,000 SODIUM TETRABORATE Applying Ready to Use Formulations via Trigger

Pump Sprayer 0.06 lb ai/ gallon 0.125 gallons 123 0.00092 0.000013 21.49 0.0000028 140,000,000 Exposure Scenario Application Rate Application Rate Units Area Treated Daily Units Inhalation Unit Exposure ( µ g/ lb ai) Inhalation Exposurea ( mg/ day) Inhalation Doseb ( mg/ kgday % boron Inhalation Doseequivalentc ( mg/ kg day) Inhalation MOEd Page 68 of 86 DISODIUM OCTABORATE Mixing/ Loading/ Applying Emulsifiable Concentrates with a Paint Brush 2.72 lb ai/ gallon 0.264 gallons 284 0.2 0.0029 25.00 0.00073 550,000 DISODIUM OCTABORATE TETRAHYDRATE Mixing/ Loading/ Applying Emulsifiable Concentrates with Low Pressure Handwand 1 lb ai/ gallon 10 gallons 30 0.3 0.0043 20.96 0.0009 440,000 Mixing/ Loading/ Applying Emulsifiable Concentrates with a Paint Brush 1 lb ai/ gallon 10 gallons 284 2.8 0.041 20.96 0.0086 47,000 Applying Ready to Use Formulations via Trigger

Pump Sprayer 0.23 lb ai/ gallon 1 gallons 123 0.028 0.0004 20.96 0.000084 4,800,000 Applying Ready to Use Formulations via Trigger

Pump Sprayer 1 lb ai/ gallon 10 gallons 123 1.2 0.018 20.96 0.0038 110,000 a Inhalation Exposure = ( Application rate)*( Area treated daily)*( Inhalation unit exposure)/( 1000).

b Inhalation Dose = ( Inhalation exposure)/( Adult body weight).

c Inhalation Dose equivalent = ( Inhalation dose) * ( percent boron).

d MOE = NOAEL ( 8.8 mg/ kg day)/ Inhalation dose equivalent. Page 69 of 86 4.0 ACTIVE INGREDIENT CONSUMER USE RESIDENTIAL EXPOSURE CEM Inputs ID Number: Unknown Product: Sodium tetraborate decahydrate Chemical Name: sodium tetraborate decahydrate Scenario: General Purpose Cleaner Population: Adult Molecular Weight ( g/ mole): 381.9 Vapor Pressure ( torr): 1e 06 Weight Fraction  Median ( unitless): 0.07 Weight Fraction  90% ( unitless): 0.13 Inhalation Inputs Frequency of Use ( events/ yr): 300 Years of Use: 57 Mass of Product Used per Event  Median ( g): 61.5 Mass of Product Used per Event  90% ( g): 123 Inhalation Rate During Use ( m3/ hr): 0.55 Duration of Use  Median ( hours/ event): 0.667 Inhalation Rate After Use ( m3/ hr): 0.55 Duration of Use  90% ( hours/ event): 1.42 Zone 1 Volume ( m3): 20 Whole House Volume ( m3): 369 Air Exchange Rate ( air exchanges/ hr): 0.45 Body Weight ( kg): 71.8 Activity Patterns User: 1111111221542467422744411 Start Time: 7 Non User: Room of Use: 2. Kitchen Hour: 0 6 12 18 Dermal Inputs Frequency of Use  Body ( events/ yr): 300 SA/ BW  Body ( cm2/ kg): 15.6 Amount Retained / Absorbed to Skin ( g/ cm2 event): 3.6e 05 Avg. Time, LADDpot, LADCpot ( days): 2.74e+ 04 Avg. Time, ADDpot, ADCpot ( days): 2.08e+ 04 Avg. Time, ADRpot, Cppot ( days): 1.00e+ 00 Page 70 of 86 CEM Inhalation Exposure Estimates ID Number: sodium tetraborate decahydrate Scenario: General Purpose Cleaner Population: Adult Inhalation Rate ( m3/ day): 0.55 Years of Use ( years): 57 Body Weight ( kg): 71.8 Frequency of Use ( events/ year): 300 Exposure Units Result AT ( days)

Chronic Cancer LADDpot ( mg/ kg day) 1.44e 03 2.74e+ 04 LADCpot ( mg/ m3) 7.84e 03 2.74e+ 04 Chronic Non Cancer ADDpot ( mg/ kg day) 1.90e 03 2.08e+ 04 ADCpot ( mg/ m3) 1.03e 02 2.08e+ 04 Acute ADRpot ( mg/ kg day) 1.91e 04 1.00e+ 00 Cppot ( mg/ m3) 2.21e 03 1.00e+ 00 LADD  Lifetime Average Daily Dose ( mg/ kg day) LADC  Lifetime Average Daily Concentration ( mg/ m3)

ADD  Average Daily Dose ( mg/ kg day) ADC  Average Daily Concentration ( mug/ m3)

ADR  Acute Dose Rate ( mg/ kg day) Cp  Peak Concentration ( mg/ m3)

Note: 75 years = 2.738e+ 04 days pot  potential dose Note: The general Agency guidance for assessing short term, infrequent events ( for most chemicals, an exposure of less than 24 hours that occurs no more frequently than monthly) is to treat such events as independent, acute exposures rather than as chronic exposure. Thus, estimates of long term average exposure like ADD or ADC may not be appropriate for use in assessing risks associated with this type of exposure pattern. ( Methods for Exposure Response Analysis for Acute Inhalation Exposure to Chemicals ( External Review Draft). EPA/ 600/ R 98/ 051. April 1998 Page 71 of 86 CEM Inputs ID Number: Unknown Product: sodium tetraborate decahydrate Chemical Name: sodium tetraborate decahydrate Scenario: Laundry Detergent Population: Adult Molecular Weight ( g/ mole): 381.9 Vapor Pressure ( torr): 1e 06 Weight Fraction  Median ( unitless): 0.01 Weight Fraction  90% ( unitless): 0.05 Inhalation Inputs Frequency of Use ( events/ yr): 312 Years of Use: 57 Mass of Product Used per Event  Median ( g): 200 Mass of Product Used per Event  90% ( g): 400 Inhalation Rate During Use ( m3/ hr): 0.55 Duration of Use  Median ( hours/ event): 0.333 Inhalation Rate After Use ( m3/ hr): 0.55 Duration of Use  90% ( hours/ event): 0.667 Zone 1 Volume ( m3): 20 Whole House Volume ( m3): 369 Air Exchange Rate ( air exchanges/ hr): 0.45 Body Weight ( kg): 71.8 Activity Patterns User: 1111111235542467422744411 Start Time: 9 Non User: Room of Use: 5. Utility Room Hour: 0 6 12 18 Dermal Inputs Frequency of Use  Body ( events/ yr): 52 SA/ BW  Body ( cm2/ kg): 15.6 Amount Retained / Absorbed to Skin ( g/ cm2 event): 1.13e 05 Avg. Time, LADDpot, LADCpot ( days): 2.74e+ 04 Avg. Time, ADDpot, ADCpot ( days): 2.08e+ 04 Avg. Time, ADRpot, Cppot ( days): 1.00e+ 00 Page 72 of 86 CEM Inhalation Exposure Estimates ID Number: sodium tetraborate decahydrate Scenario: Laundry Detergent Population: Adult Inhalation Rate ( m3/ day): 0.55 Years of Use ( years): 57 Body Weight ( kg): 71.8 Frequency of Use ( events/ year): 312 Exposure Units Result AT ( days)

Chronic Cancer LADDpot ( mg/ kg day) 1.91e 07 2.74e+ 04 LADCpot ( mg/ m3) 1.04e 06 2.74e+ 04 Chronic Non Cancer ADDpot ( mg/ kg day) 2.52e 07 2.08e+ 04 ADCpot ( mg/ m3) 1.37e 06 2.08e+ 04 Acute ADRpot ( mg/ kg day) 5.96e 06 1.00e+ 00 Cppot ( mg/ m3) 8.33e 04 1.00e+ 00 LADD  Lifetime Average Daily Dose ( mg/ kg day) LADC  Lifetime Average Daily Concentration ( mg/ m3)

ADD  Average Daily Dose ( mg/ kg day) ADC  Average Daily Concentration ( mug/ m3)

ADR  Acute Dose Rate ( mg/ kg day) Cp  Peak Concentration ( mg/ m3)

Note: 75 years = 2.738e+ 04 days pot  potential dose Note: The general Agency guidance for assessing short term, infrequent events ( for most chemicals, an exposure of less than 24 hours that occurs no more frequently than monthly) is to treat such events as independent, acute exposures rather than as chronic exposure. Thus, estimates of long term average exposure like ADD or ADC may not be appropriate for use in assessing risks associated with this type of exposure pattern. ( Methods for Exposure Response Analysis for Acute Inhalation Exposure to Chemicals ( External Review Draft). EPA/ 600/ R 98/ 051. April 1998 Page 73 of 86 CEM Inputs ID Number: Unknown Product: sodium tetraborate Chemical Name: sodium tetraborate Scenario: Laundry Detergent Population: Adult Molecular Weight ( g/ mole): 201.3 Vapor Pressure ( torr): 1e 06 Weight Fraction  Median ( unitless): 0.01 Weight Fraction  90% ( unitless): 0.05 Inhalation Inputs Frequency of Use ( events/ yr): 312 Years of Use: 57 Mass of Product Used per Event  Median ( g): 200 Mass of Product Used per Event  90% ( g): 400 Inhalation Rate During Use ( m3/ hr): 0.55 Duration of Use  Median ( hours/ event): 0.333 Inhalation Rate After Use ( m3/ hr): 0.55 Duration of Use  90% ( hours/ event): 0.667 Zone 1 Volume ( m3): 20 Whole House Volume ( m3): 369 Air Exchange Rate ( air exchanges/ hr): 0.45 Body Weight ( kg): 71.8 Activity Patterns User: 1111111235542467422744411 Start Time: 9 Non User: Room of Use: 5. Utility Room Hour: 0 6 12 18 Dermal Inputs Frequency of Use  Body ( events/ yr): 52 SA/ BW  Body ( cm2/ kg): 15.6 Amount Retained / Absorbed to Skin ( g/ cm2 event): 1.13e 05 Avg. Time, LADDpot, LADCpot ( days): 2.74e+ 04 Avg. Time, ADDpot, ADCpot ( days): 2.08e+ 04 Avg. Time, ADRpot, Cppot ( days): 1.00e+ 00 Page 74 of 86 CEM Inhalation Exposure Estimates ID Number: sodium tetraborate Scenario: Laundry Detergent Population: Adult Inhalation Rate ( m3/ day): 0.55 Years of Use ( years): 57 Body Weight ( kg): 71.8 Frequency of Use ( events/ year): 312 Exposure Units Result AT ( days)

Chronic Cancer LADDpot ( mg/ kg day) 1.04e 07 2.74e+ 04 LADCpot ( mg/ m3) 5.65e 07 2.74e+ 04 Chronic Non Cancer ADDpot ( mg/ kg day) 1.37e 07 2.08e+ 04 ADCpot ( mg/ m3) 7.43e 07 2.08e+ 04 Acute ADRpot ( mg/ kg day) 3.23e 06 1.00e+ 00 Cppot ( mg/ m3) 4.52e 04 1.00e+ 00 LADD  Lifetime Average Daily Dose ( mg/ kg day) LADC  Lifetime Average Daily Concentration ( mg/ m3)

ADD  Average Daily Dose ( mg/ kg day) ADC  Average Daily Concentration ( mug/ m3)

ADR  Acute Dose Rate ( mg/ kg day) Cp  Peak Concentration ( mg/ m3)

Note: 75 years = 2.738e+ 04 days pot  potential dose Note: The general Agency guidance for assessing short term, infrequent events ( for most chemicals, an exposure of less than 24 hours that occurs no more frequently than monthly) is to treat such events as independent, acute exposures rather than as chronic exposure. Thus, estimates of long term average exposure like ADD or ADC may not be appropriate for use in assessing risks associated with this type of exposure pattern. ( Methods for Exposure Response Analysis for Acute Inhalation Exposure to Chemicals ( External Review Draft). EPA/ 600/ R 98/ 051. April 1998. Page 75 of 86 5.0 INERT INGREDIENT CONSUMER USE RESIDENTIAL EXPOSURE CEM Inputs ID Number: Unknown Product: Boric Acid ( inert ingredient) Chemical Name: Boric Acid Scenario: General Purpose Cleaner Population: Adult Molecular Weight ( g/ mole): 61.9 Vapor Pressure ( torr): 0.0001 Weight Fraction  Median ( unitless): 0.15 Weight Fraction  90% ( unitless): 0.15 Inhalation Inputs Frequency of Use ( events/ yr): 300 Years of Use: 57 Mass of Product Used per Event  Median ( g): 61.5 Mass of Product Used per Event  90% ( g): 123 Inhalation Rate During Use ( m3/ hr): 0.55 Duration of Use  Median ( hours/ event): 0.667 Inhalation Rate After Use ( m3/ hr): 0.55 Duration of Use  90% ( hours/ event): 1.42 Zone 1 Volume ( m3): 20 Whole House Volume ( m3): 369 Air Exchange Rate ( air exchanges/ hr): 0.45 Body Weight ( kg): 71.8 Activity Patterns User: 1111111221542467422744411 Start Time: 7 Non User: Room of Use: 2. Kitchen Hour: 0 6 12 18 Dermal Inputs Frequency of Use  Body ( events/ yr): 300 SA/ BW  Body ( cm2/ kg): 15.6 Amount Retained / Absorbed to Skin ( g/ cm2 event): 3.6e 05 Avg. Time, LADDpot, LADCpot ( days): 2.74e+ 04 Avg. Time, ADDpot, ADCpot ( days): 2.08e+ 04 Avg. Time, ADRpot, Cppot ( days): 1.00e+ 00 Page 76 of 86 CEM Inhalation Exposure Estimates ID Number: Unknown Scenario: General Purpose Cleaner Population: Adult Inhalation Rate ( m3/ day): 0.55 Years of Use ( years): 57 Body Weight ( kg): 71.8 Frequency of Use ( events/ year): 300 Exposure Units Result AT ( days)

Chronic Cancer LADDpot ( mg/ kg day) 4.08e 02 2.74e+ 04 LADCpot ( mg/ m3) 2.22e 01 2.74e+ 04 Chronic Non Cancer ADDpot ( mg/ kg day) 5.36e 02 2.08e+ 04 ADCpot ( mg/ m3) 2.92e 01 2.08e+ 04 Acute ADRpot ( mg/ kg day) 3.10e 03 1.00e+ 00 Cppot ( mg/ m3) 3.63e 02 1.00e+ 00 LADD  Lifetime Average Daily Dose ( mg/ kg day) LADC  Lifetime Average Daily Concentration ( mg/ m3)

ADD  Average Daily Dose ( mg/ kg day) ADC  Average Daily Concentration ( mug/ m3)

ADR  Acute Dose Rate ( mg/ kg day) Cp  Peak Concentration ( mg/ m3) Page 77 of 86 6.0 ACTIVE INGREDIENT SWIMMER POSTAPPLICATION EXPOSURE SWIMODEL ORAL EXPOSURE RESULTS FOR Adult Non Competitive Male SWIMMER EXPOSED TO Sodium tetraborate pentahydrate Toral Tdermal Tinhale Texp ADD LADD 13.50 0.00 0.00 13.50 0.14 1.49E 03 Where:

Toral = Total oral exposure per event ( mg/ event) Tdermal = Total dermal exposure per event ( mg/ event) Tinhale = Total inhalation exposure per event ( mg/ event) Texp = Total exposure ( all routes) ( mg/ event) ADD = Average daily dose ( mg/ kg day) LADD = Lifetime Average daily dose ( mg/ kg day)

SWIMODEL INPUTS Chemical concentration in water ( Cw): 5.40E+ 05 µ g/ liter Exposure time ( period over which exposure is averaged) ( ET): 1.00 hours/ event ( 90% ile value used)

Contact rate ( water ingested) ( CR): 2.50E 02 liters/ hour Surface area of whole body ( SA): 3.02 m2 ( 90% ile value used)

Henry's Law Constant ( unitless) 0.10 Inhalation rate ( IR): 1.00 m3/ hr Exposure frequency ( EF): 9.00 events/ year Exposure duration ( ED): 30.00 years Body weight ( BW): 95.70 kg ( 90% ile value used)

Averaging time ( AT): 70.00 years Permeability coefficient ( Kp) 1.00E 03 cm/ hr Ambient air temperature N/ A degrees C Henry's Law Constant N/ A atm m3/ mol Solubility N/ A N/ A Molecular weight N/ A g/ mole Vapor pressure N/ A torr Vapor concentration 0.00 ug/ m3 Page 78 of 86 SWIMODEL ORAL EXPOSURE RESULTS FOR Adult Non Competitive Female SWIMMER EXPOSED TO Sodium tetraborate pentahydrate Toral Tdermal Tinhale Texp ADD LADD 13.50 0.00 0.00 13.50 0.16 1.69E 03 Where:

Toral = Total oral exposure per event ( mg/ event)

Tdermal = Total dermal exposure per event ( mg/ event) Tinhale = Total inhalation exposure per event ( mg/ event) Texp = Total exposure ( all routes) ( mg/ event) ADD = Average daily dose ( mg/ kg day) LADD = Lifetime Average daily dose ( mg/ kg day)

SWIMODEL INPUTS Chemical concentration in water ( Cw): 5.40E+ 05 µ g/ liter Exposure time ( period over which exposure is averaged) ( ET): 1.00 hours/ event ( 90% ile value used)

Contact rate ( water ingested) ( CR): 2.50E 02 liters/ hour Surface area of whole body ( SA): 2.67 m2 ( 90% ile value used)

Henry's Law Constant ( unitless) 0.10 Inhalation rate ( IR): 1.00 m3/ hr Exposure frequency ( EF): 9.00 events/ year Exposure duration ( ED): 30.00 years Body weight ( BW): 84.40 kg ( 90% ile value used)

Averaging time ( AT): 70.00 years Permeability coefficient ( Kp) 1.00E 03 cm/ hr Ambient air temperature N/ A degrees C Henry's Law Constant N/ A atm m3/ mol Solubility N/ A N/ A Molecular weight N/ A g/ mole Vapor pressure N/ A torr Vapor concentration 0.00 ug/ m3 Page 79 of 86 SWIMODEL ORAL EXPOSURE RESULTS FOR Child ( 7 10) Non Competitive SWIMMER EXPOSED TO Sodium tetraborate pentahydrate Toral Tdermal Tinhale Texp ADD LADD 54.00 0.00 0.00 54.00 1.43 2.01E 03 Where:

Toral = Total oral exposure per event ( mg/ event)

Tdermal = Total dermal exposure per event ( mg/ event) Tinhale = Total inhalation exposure per event ( mg/ event) Texp = Total exposure ( all routes) ( mg/ event) ADD = Average daily dose ( mg/ kg day) LADD = Lifetime Average daily dose ( mg/ kg day)

SWIMODEL INPUTS Chemical concentration in water ( Cw): 5.40E+ 05 µ g/ liter Exposure time ( period over which exposure is averaged) ( ET): 2.00 hours/ event ( 90% ile value used)

Contact rate ( water ingested) ( CR): 5.00E 02 liters/ hour Surface area of whole body ( SA): 1.89 m2 ( 90% ile value used)

Henry's Law Constant ( unitless) 0.10 Inhalation rate ( IR): 1.00 m3/ hr Exposure frequency ( EF): 9.00 events/ year Exposure duration ( ED): 4.00 years Body weight ( BW): 37.80 kg ( 90% ile value used)

Averaging time ( AT): 70.00 years Permeability coefficient ( Kp) 1.00E 03 cm/ hr Ambient air temperature N/ A degrees C Henry's Law Constant N/ A atm m3/ mol Solubility N/ A N/ A Molecular weight N/ A g/ mole Vapor pressure N/ A torr Vapor concentration 0.00 ug/ m3 Page 80 of 86 SWIMODEL ORAL EXPOSURE RESULTS FOR Child ( 11 14) Non Competitive SWIMMER EXPOSED TO Sodium tetraborate pentahydrate Toral Tdermal Tinhale Texp ADD LADD 54.00 0.00 0.00 54.00 0.87 1.23E 03 Where:

Toral = Total oral exposure per event ( mg/ event)

Tdermal = Total dermal exposure per event ( mg/ event) Tinhale = Total inhalation exposure per event ( mg/ event) Texp = Total exposure ( all routes) ( mg/ event) ADD = Average daily dose ( mg/ kg day) LADD = Lifetime Average daily dose ( mg/ kg day)

SWIMODEL INPUTS Chemical concentration in water ( Cw): 5.40E+ 05 µ g/ liter Exposure time ( period over which exposure is averaged) ( ET): 2.00 hours/ event ( 90% ile value used)

Contact rate ( water ingested) ( CR): 5.00E 02 liters/ hour Surface area of whole body ( SA): 3.11 m2 ( 90% ile value used)

Henry's Law Constant ( unitless) 0.10 Inhalation rate ( IR): 1.00 m3/ hr Exposure frequency ( EF): 9.00 events/ year Exposure duration ( ED): 4.00 years Body weight ( BW): 62.00 kg ( 90% ile value used)

Averaging time ( AT): 70.00 years Permeability coefficient ( Kp) 1.00E 03 cm/ hr Ambient air temperature N/ A degrees C Henry's Law Constant N/ A atm m3/ mol Solubility N/ A N/ A Molecular weight N/ A g/ mole Vapor pressure N/ A torr Vapor concentration 0.00 ug/ m3 Page 81 of 86 SWIMODEL INHALATION EXPOSURE RESULTS FOR Adult Non Competitive Male SWIMMER EXPOSED TO Sodium tetraborate pentahydrate Toral Tdermal Tinhale Texp ADD LADD N/ A 0.00 0.24 0.24 2.52E 03 2.66E 05 Where:

Toral = Total oral exposure per event ( mg/ event)

Tdermal = Total dermal exposure per event ( mg/ event) Tinhale = Total inhalation exposure per event ( mg/ event) Texp = Total exposure ( all routes) ( mg/ event) ADD = Average daily dose ( mg/ kg day) LADD = Lifetime Average daily dose ( mg/ kg day)

SWIMODEL INPUTS Chemical concentration in water ( Cw): 5.40E+ 05 µ g/ liter Exposure time ( period over which exposure is averaged) ( ET): 1.00 hours/ event ( 90% ile value used)

Contact rate ( water ingested) ( CR): 2.50E 02 liters/ hour Surface area of whole body ( SA): 3.02 m2 ( 90% ile value used)

Henry's Law Constant ( unitless) 4.47E 07 Inhalation rate ( IR): 1.00 m3/ hr Exposure frequency ( EF): 9.00 events/ year Exposure duration ( ED): 30.00 years Body weight ( BW): 95.70 kg ( 90% ile value used)

Averaging time ( AT): 70.00 years Permeability coefficient ( Kp) 1.00E 03 cm/ hr Ambient air temperature 20.00 degrees C Henry's Law Constant N/ A atm m3/ mol Solubility 5.55E 306 N/ A Molecular weight N/ A g/ mole Vapor pressure 1.00E 06 torr Vapor concentration 241.24 ug/ m3 Page 82 of 86 SWIMODEL INHALATION EXPOSURE RESULTS FOR Adult Non Competitive Female SWIMMER EXPOSED TO Sodium tetraborate pentahydrate Toral Tdermal Tinhale Texp ADD LADD N/ A 0.00 0.24 0.24 2.81E 03 2.97E 05 Where:

Toral = Total oral exposure per event ( mg/ event)

Tdermal = Total dermal exposure per event ( mg/ event) Tinhale = Total inhalation exposure per event ( mg/ event) Texp = Total exposure ( all routes) ( mg/ event) ADD = Average daily dose ( mg/ kg day) LADD = Lifetime Average daily dose ( mg/ kg day)

SWIMODEL INPUTS Chemical concentration in water ( Cw): 5.40E+ 05 µ g/ liter Exposure time ( period over which exposure is averaged) ( ET): 1.00 hours/ event ( 90% ile value used)

Contact rate ( water ingested) ( CR): 2.50E 02 liters/ hour Surface area of whole body ( SA): 2.67 m2 ( 90% ile value used)

Henry's Law Constant ( unitless) 4.47E 07 Inhalation rate ( IR): 1.00 m3/ hr Exposure frequency ( EF): 9.00 events/ year Exposure duration ( ED): 30.00 years Body weight ( BW): 84.40 kg ( 90% ile value used)

Averaging time ( AT): 70.00 years Permeability coefficient ( Kp) 1.00E 03 cm/ hr Ambient air temperature 20.00 degrees C Henry's Law Constant N/ A atm m3/ mol Solubility 5.55E 306 N/ A Molecular weight N/ A g/ mole Vapor pressure 1.00E 06 torr Vapor concentration 237.20 ug/ m3 Page 83 of 86 SWIMODEL INHALATION EXPOSURE RESULTS FOR Child ( 7 10) Non Competitive SWIMMER EXPOSED TO Sodium tetraborate pentahydrate Toral Tdermal Tinhale Texp ADD LADD N/ A 0.00 0.47 0.47 1.26E 02 1.77E 05 Where:

Toral = Total oral exposure per event ( mg/ event) Tdermal = Total dermal exposure per event ( mg/ event) Tinhale = Total inhalation exposure per event ( mg/ event) Texp = Total exposure ( all routes) ( mg/ event) ADD = Average daily dose ( mg/ kg day) LADD = Lifetime Average daily dose ( mg/ kg day)

SWIMODEL INPUTS Chemical concentration in water ( Cw): 5.40E+ 05 µ g/ liter Exposure time ( period over which exposure is averaged) ( ET): 2.00 hours/ event ( 90% ile value used)

Contact rate ( water ingested) ( CR): 5.00E 02 liters/ hour Surface area of whole body ( SA): 1.89 m2 ( 90% ile value used)

Henry's Law Constant ( unitless) 4.47E 07 Inhalation rate ( IR): 1.00 m3/ hr Exposure frequency ( EF): 9.00 events/ year Exposure duration ( ED): 4.00 years Body weight ( BW): 37.80 kg ( 90% ile value used)

Averaging time ( AT): 70.00 years Permeability coefficient ( Kp) 1.00E 03 cm/ hr Ambient air temperature 20.00 degrees C Henry's Law Constant N/ A atm m3/ mol Solubility 5.55E 306 N/ A Molecular weight N/ A g/ mole Vapor pressure 1.00E 06 torr Vapor concentration 237.20 ug/ m3 Page 84 of 86 SWIMODEL INHALATION EXPOSURE RESULTS FOR Child ( 11 14) Non Competitive SWIMMER EXPOSED TO Sodium tetraborate pentahydrate Toral Tdermal Tinhale Texp ADD LADD N/ A 0.00 0.47 0.47 7.65E 03 1.08E 05 Where:

Toral = Total oral exposure per event ( mg/ event)

Tdermal = Total dermal exposure per event ( mg/ event) Tinhale = Total inhalation exposure per event ( mg/ event) Texp = Total exposure ( all routes) ( mg/ event) ADD = Average daily dose ( mg/ kg day) LADD = Lifetime Average daily dose ( mg/ kg day)

SWIMODEL INPUTS Chemical concentration in water ( Cw): 5.40E+ 05 µ g/ liter Exposure time ( period over which exposure is averaged) ( ET): 2.00 hours/ event ( 90% ile value used)

Contact rate ( water ingested) ( CR): 5.00E 02 liters/ hour Surface area of whole body ( SA): 3.11 m2 ( 90% ile value used)

Henry's Law Constant ( unitless) 4.47E 07 Inhalation rate ( IR): 1.00 m3/ hr Exposure frequency ( EF): 9.00 events/ year Exposure duration ( ED): 4.00 years Body weight ( BW): 62.00 kg ( 90% ile value used)

Averaging time ( AT): 70.00 years Permeability coefficient ( Kp) 1.00E 03 cm/ hr Ambient air temperature 20.00 degrees C Henry's Law Constant N/ A atm m3/ mol Solubility 5.55E 306 N/ A Molecular weight N/ A g/ mole Vapor pressure 1.00E 06 torr Vapor concentration 237.20 ug/ m3 Page 85 of 86 6.0 INERT INGREDIENT SWIMMER POSTAPPLICATION EXPOSURE SWIMODEL ORAL RESULTS FOR Child ( 7 10) Non Competitive SWIMMER EXPOSED TO Boric Acid Toral Tdermal Tinhale Texp ADD LADD 5.38E 02 0.00 0.00 5.38E 02 1.42E 03 2.01E 06 Where:

Toral = Total oral exposure per event ( mg/ event) Tdermal = Total dermal exposure per event ( mg/ event) Tinhale = Total inhalation exposure per event ( mg/ event)

Texp = Total exposure ( all routes) ( mg/ event) ADD = Average daily dose ( mg/ kg day) LADD = Lifetime Average daily dose ( mg/ kg day)

SWIMODEL INPUTS Chemical concentration in water ( Cw): 538.00 µ g/ liter Exposure time ( period over which exposure is averaged) ( ET): 2.00 hours/ event ( 90% ile value used)

Contact rate ( water ingested) ( CR): 5.00E 02 liters/ hour Surface area of whole body ( SA): 1.89 m2 ( 90% ile value used)

Henry's Law Constant ( unitless) 0.10 Inhalation rate ( IR): 1.00 m3/ hr Exposure frequency ( EF): 9.00 events/ year Exposure duration ( ED): 4.00 years Body weight ( BW): 37.80 kg ( 90% ile value used)

Averaging time ( AT): 70.00 years Permeability coefficient ( Kp) 1.00E 03 cm/ hr Ambient air temperature N/ A degrees C Henry's Law Constant N/ A atm m3/ mol Solubility N/ A N/ A Molecular weight N/ A g/ mole Vapor pressure N/ A torr Vapor concentration 0.00 ug/ m3 Page 86 of 86 SWIMODEL ORAL RESULTS FOR Child ( 11 14) Non Competitive SWIMMER EXPOSED TO Boric Acid Toral Tdermal Tinhale Texp ADD LADD 5.38E 02 0.00 0.00 5.38E 02 8.68E 04 1.22E 06 Where:

Toral = Total oral exposure per event ( mg/ event)

Tdermal = Total dermal exposure per event ( mg/ event) Tinhale = Total inhalation exposure per event ( mg/ event) Texp = Total exposure ( all routes) ( mg/ event) ADD = Average daily dose ( mg/ kg day) LADD = Lifetime Average daily dose ( mg/ kg day)

SWIMODEL INPUTS Chemical concentration in water ( Cw): 538.00 µ g/ liter Exposure time ( period over which exposure is averaged) ( ET): 2.00 hours/ event ( 90% ile value used)

Contact rate ( water ingested) ( CR): 5.00E 02 liters/ hour Surface area of whole body ( SA): 3.11 m2 ( 90% ile value used)

Henry's Law Constant ( unitless) 0.10 Inhalation rate ( IR): 1.00 m3/ hr Exposure frequency ( EF): 9.00 events/ year Exposure duration ( ED): 4.00 years Body weight ( BW): 62.00 kg ( 90% ile value used)

Averaging time ( AT): 70.00 years Permeability coefficient ( Kp) 1.00E 03 cm/ hr Ambient air temperature N/ A degrees C Henry's Law Constant N/ A atm m3/ mol Solubility N/ A N/ A Molecular weight N/ A g/ mole Vapor pressure N/ A torr Vapor concentration 0.00 ug/ m3


[Federal Register Volume 83, Number 63 (Monday, April 2, 2018)]
[Notices]
[Pages 13979-13980]
[FR Doc No: 2018-06626]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER18-1174-000]

Imperial Valley Solar 2, 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 proceeding of
Imperial

Valley Solar 2, 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 April 16, 2018.
    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 should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street, NE, Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the website that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
[email protected]. or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: March 27, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-06626 Filed 3-30-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: December 20, 2010 (Volume 75, Number 243)]
[Notices]
[Page 79361-79362]
[DOCID:fr20de10-925]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

December 7, 2010.
    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER10-1820-001.
    Applicants: Northern States Power Company, a Wisconsin corporation.
    Description: Northern States Power Company, a Wisconsin corporation
submits tariff filing per 35: 20100929 Compliance Filing Revising
Baseline to be effective 7/20/2010.
    Filed Date: 09/29/2010.
    Accession Number: 20100929-5240.
    Comment Date: 5 p.m. Eastern Time on Tuesday, December 28, 2010.

    Docket Numbers: ER11-2281-000.
    Applicants: ISO New England Inc.
    Description: Filing of ICR-Related Values for 2011/2012 and 2012/
2013 Annual Reconfiguration Auctions.
    Filed Date: 12/01/2010.
    Accession Number: 20101201-5279.
    Comment Date: 5 p.m. Eastern Time on Wednesday, December 22, 2010.

    Docket Numbers: ER11-2304-000.
    Applicants: City of Banning, California.
    Description: City of Banning, California submits tariff filing per
35.1: Baseline TO Tariff to be effective 12/7/2010.
    Filed Date: 12/07/2010.
    Accession Number: 20101207-5035.
    Comment Date: 5 p.m. Eastern Time on Tuesday, December 28, 2010.

    Docket Numbers: ER11-2305-000.
    Applicants: City of Anaheim, California.
    Description: City of Anaheim, California submits tariff filing per
35.1: Baseline TO Tariff to be effective 12/7/2010.
    Filed Date: 12/07/2010.
    Accession Number: 20101207-5044.
    Comment Date: 5 p.m. Eastern Time on Tuesday, December 28, 2010.

    Docket Numbers: ER11-2306-000.
    Applicants: Southern California Edison Company.
    Description: Southern California Edison Company submits tariff
filing per 35.13(a)(2)(iii): SGIA & Service Agreement with Lucerne
Solar to be effective 2/6/2011.
    Filed Date: 12/07/2010.
    Accession Number: 20101207-5112.
    Comment Date: 5 p.m. Eastern Time on Tuesday, December 28, 2010.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    As it relates to any qualifying facility filings, the notices of
self-certification [or self-recertification] listed above, do not
institute a proceeding regarding qualifying facility status. A notice
of self-certification [or self-recertification] simply provides
notification that the entity making the filing has determined the
facility named in the notice meets the applicable criteria to be a
qualifying facility. Intervention and/or protest do not lie in dockets
that are qualifying facility self-certifications or self-
recertifications. Any person seeking to challenge such qualifying
facility status may do so by filing a motion pursuant to 18 CFR
292.207(d)(iii). Intervention and protests may be filed in response to
notices of qualifying facility dockets other than self-certifications
and self-recertifications.
    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 should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.

    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2010-31838 Filed 12-17-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 33 (Tuesday, February 19, 2013)]
[Notices]
[Pages 11636-11637]
[FR Doc No: 2013-03711]

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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: EC13-74-000.
    Applicants: Pasco Cogen, Ltd., Lake Investment, LP, NCP Lake Power,
LLC, Teton New Lake, LLC, Auburndale LP, LLC, Auburndale GP, LLC, Dade
Investment, LP, NCP Dade Power, LLC.
    Description: Application for Approval under Section 203 of the
Federal Power Act and Requests for Expedited Consideration and
Confidential Treatment of Pasco Cogen, Ltd., et al.
    Filed Date: 2/8/13.
    Accession Number: 20130208-5162.
    Comments Due: 5 p.m. ET 3/1/13.

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

    Docket Numbers: ER13-692-002.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest Independent Transmission System Operator, Inc.
submits tariff filing per 35.17(b): 2012-02-08--OASIS Replacement--2 to
be effective 4/15/2013.
    Filed Date: 2/8/13.
    Accession Number: 20130208-5161.
    Comments Due: 5 p.m. ET 3/1/13.

    Docket Numbers: ER13-912-000.
    Applicants: Southwest Power Pool, Inc.
    Description: 2522 Tres Amigas Interconnection Agreement to be
effective 1/25/2013.
    Filed Date: 2/8/13.
    Accession Number: 20130208-5131.
    Comments Due: 5 p.m. ET 3/1/13.

    Docket Numbers: ER13-913-000.
    Applicants: Ohio Valley Electric Corporation.
    Description: OATT Order No. 1000. Compliance Filing to be effective
12/31/9998.
    Filed Date: 2/8/13.
    Accession Number: 20130208-5137.

    Comments Due: 5 p.m. ET 3/25/13.

    Docket Numbers: ER13-914-000.
    Applicants: Green Mountain Power Corporation.
    Description: Green Mountain Power filing of Rate Schedule No. 73 to
be effective 2/8/2013.
    Filed Date: 2/8/13.
    Accession Number: 20130208-5149.
    Comments Due: 5 p.m. ET 3/1/13.

    Docket Numbers: ER13-915-000.
    Applicants: Pinpoint Power, LLC.
    Description: Pinpoint Power, LLC submits Pinpoint Cancellation to
be effective 4/9/2013.
    Filed Date: 2/8/13.
    Accession Number: 20130208-5160.
    Comments Due: 5 p.m. ET 3/1/13.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or 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: February 11, 2013.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2013-03711 Filed 2-15-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: March 5, 2008 (Volume 73, Number 44)]
[Proposed Rules]
[Page 11845-11846]
[DOCID:fr05mr08-14]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2007-1188; FRL-8537-5]

Approval and Promulgation of Air Quality Implementation Plans;
Delaware; Control of Stationary Generator Emissions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to approve a State Implementation Plan (SIP)
revision submitted by the State of Delaware. This SIP revision contains
provisions to control emissions from stationary generators. This action
is being taken under the Clean Air Act (CAA).

DATES: Written comments must be received on or before April 4, 2008.

ADDRESSES: Submit your comments, identified by Docket ID Number EPA-
R03-OAR-2007-1188 by one of the following methods:
    A. www.regulations.gov. Follow the on-line instructions for
submitting comments.
    B. E-mail<EMAIL_ADDRESS>    C. Mail: EPA-R03-OAR-2007-1188, Cristina Fernandez, Chief, Air
Quality Planning Branch, Mailcode 3AP21, U.S. Environmental Protection
Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103.
    D. Hand Delivery: At the previously-listed EPA Region III address.
Such deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-R03-OAR-
2007-1188. EPA's policy is that all comments received will be included
in the public docket without change, and may be made available online
at www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through www.regulations.gov or e-mail.
The www.regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through www.regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the public docket and made available
on the Internet. If you submit an electronic comment, EPA recommends
that you include your name and other contact information in the body of
your comment and with any disk or CD-ROM you submit. If EPA cannot read
your comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the electronic docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in www.regulations.gov or
in hard copy during normal business hours at the Air Protection
Division, U.S. Environmental Protection Agency, Region III, 1650 Arch
Street, Philadelphia, Pennsylvania 19103.

Copies of the State submittal are available at the Delaware Department
of Natural Resources & Environmental Control, 89 Kings Highway, P.O.
Box 1401, Dover, Delaware 19901.

FOR FURTHER INFORMATION CONTACT: Rose Quinto,<PHONE_NUMBER>, or by e-
mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On November 1, 2007, the Delaware Department of Natural Resources
and Environmental Control (DNREC) submitted a SIP revision for
Regulation No. 1144--Control of Stationary Generator Emissions. The SIP
revision applies to new, existing, emergency, and distributed
stationary generators.

II. Summary of SIP Revision

    Regulation No. 1144 will impact any owner of a stationary
generator, except the owner of any of the following: mobile generator;
residential generator for emergency power use only; certain generators
whose emissions are already controlled; or generators with a standby
power rating of 10 kilowatts or less. Regulation No. 1144 establishes
operating requirements, fuel sulfur content limits, and recordkeeping
requirements for stationary generators. The regulation will also
require stationary generators which operate at times other than during
emergencies for testing or for maintenance to meet certain emission
standards to reduce their emissions.

III. Proposed Action

    EPA is proposing to approve the Delaware SIP revision for
Regulation No. 1144--Control of Stationary Generator Emissions
submitted on November 1, 2007. This regulation will help ensure that
the air emissions from new and existing stationary generators do not
cause or contribute to the existing air quality problems with regard to
ground-level ozone and fine particulate matter, thereby adversely
impacting public health, safety and welfare. EPA is soliciting public
comments on the issues discussed in this document. These comments will
be considered before taking final action.

IV. Statutory and Executive Order Reviews

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
proposed action is not a ``significant regulatory action'' and
therefore is not subject to review by the Office of Management and
Budget. For this reason, this action is also not subject to Executive
Order 13211, ``Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use'' (66 FR 28355 (May 22, 2001)).
This action merely proposes to approve state law as meeting Federal
requirements and imposes no additional requirements beyond those
imposed by state law. Accordingly, the Administrator certifies that
this proposed rule will not have a significant economic impact on a
substantial number of small entities under the Regulatory Flexibility
Act (5 U.S.C. 601 et seq.). Because this rule proposes to approve pre-
existing requirements under state law and does not impose any
additional enforceable duty beyond that required by state law, it does
not contain any unfunded mandate or significantly or uniquely affect
small governments, as described in the Unfunded Mandates Reform Act of
1995 (Pub. L. 104-4). This proposed rule also does not have a
substantial direct effect on one or more Indian tribes, on the
relationship between the Federal Government and Indian tribes, or on
the distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified by Executive Order 13175 (65
FR 67249, November 9, 2000), nor will it have substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government, as specified
in Executive Order 13132 (64 FR 43255, August 10, 1999), because it
merely proposes to approve a state rule implementing a Federal
requirement, and does not alter the relationship or the distribution of
power and responsibilities established in the Clean Air Act. This
proposed rule also is not subject to Executive Order 13045 (62 FR
19885, April 23, 1997), because it approves a state rule implementing a
Federal standard.
    In reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act. In
this context, in the absence of a prior existing requirement for the
State to use voluntary consensus standards (VCS), EPA has no authority
to disapprove a SIP submission for failure to use VCS. It would thus be
inconsistent with applicable law for EPA, when it reviews a SIP
submission, to use VCS in place of a SIP submission that otherwise
satisfies the provisions of the Clean Air Act. Thus, the requirements
of section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272 note) do not apply.
    As required by section 3 of Executive Order 12988 (61 FR 4729,
February 7, 1996), in issuing this proposed rule, EPA has taken the
necessary steps to eliminate drafting errors and ambiguity, minimize
potential litigation, and provide a clear legal standard for affected
conduct. EPA has complied with Executive Order 12630 (53 FR 8859, March
15, 1988) by examining the takings implications of the rule in
accordance with the ``Attorney General's Supplemental Guidelines for
the Evaluation of Risk and Avoidance of Unanticipated Takings'' issued
under the executive order. This proposed rule pertaining to Delaware's
control of stationary generator emissions, does not impose an
information collection burden under the provisions of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Nitrogen dioxide,
Ozone, Reporting and recordkeeping requirements, Volatile organic
compounds.

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

    Dated: February 25, 2008.
Donald S. Welsh,
Regional Administrator, Region III.
 [FR Doc. E8-4256 Filed 3-4-08; 8:45 am]

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