Pine Oil Occupational/ Residential Exposure Assessment Office of Pesticide Programs Antimicrobials Division U. S. Environmental Protection Agency 1801 South Bell Street Arlington, VA 22202 September 9, 2004 Page 2 of 17 EXPOSURE/ RISK ASSESSMENT AND CHARACTERIZATION EXECUTIVE SUMMARY This document contains the occupational and residential exposure assessment for industrial, commercial, and residential uses of pine oil marketed under a variety of product names. Pine oil containing products include many use sites, such as eating establishments, food processing plants, commercial/ institutional/ industrial premises and equipment, household or domestic dwellings and contents, and medical sites and items. Pine oil is used as a disinfectant, sanitizer, microbicide/ microbistat, virucide, and insecticide. Products can contain a maximum of 80% pine oil, and are generally intended to be diluted with water. Several ready to use products are available for household use in spray bottles, but these products contain < 1% of the active ingredient, pine oil. Products containing 99 to 100% pine oil are available for the manufacturing of germicides and disinfectants. Based on examination of the labels, all formulations are liquid formulations. The application rates used in the assessment are based on the maximum stated application rates on labels.

The endpoints used in this document to assess pine oil risks are the intermediate and long term dermal and short, intermediate, and long term inhalation endpoints. The intermediate and longterm dermal LOAEL is 226 mg/ kg/ day. The dermal NOAEL is based on a 90 day dermal toxicity test performed on rats. The inhalation NOAEL of 50 mg/ kg/ d is based on developmental toxicity in rats.

The scenarios considered in the risk assessment are shown in Table 1. These scenarios were selected based on examination of product labels describing uses for the product.

Several different sources of handler and postapplication exposure data were used to assess occupational and residential pine oil risks. Data from the Standard Operating Procedures ( SOPs) for Residential Exposure Assessments and Chemical Manufacturers Association ( CMA) antimicrobial exposure study were used to assess exposure. In addition, the model EFAST ( Exposure and Fate Assessment Screening Tool) was used to estimate the inhalation exposure to the vapor phase of pine oils.

In summary, the occupational dermal exposure was not of concern for any scenarios ( i. e., MOE greater than the target MOE of 100). For the inhalation exposures, the MOEs for all scenarios were higher than the target MOE of 1000 for short and intermediate term. For the residential uses of pine oil, the handler risks are not of concern except for the short term inhalation MOE for wiping ( inhalation MOE is 500, target MOE is 1000). Refinements to the amount of chemical used for wiping should be submitted by the registrant. In addition, the risks are of concern for the postapplication intermediate term incidental oral for children crawling on treated floors at day care facilities. The estimate intermediate term MOE for hand to mouth activities is 2,000 ( target intermediate term MOE = 3,000). Page 3 of 17 There are a number of uncertainties associated with this assessment ( See Section 4.0). In general, conservative values were used in cases where data were lacking and data should be submitted by the registrant to refine the input parameters.

Table 1. Pine Oil Exposure Scenarios Use Site Category Scenario Commercial/ Institutional Premises and Industrial Areas/ Premises General purpose cleaner Residential and Public Access Premises ( Residential) General purpose cleaner Washing a pet dog with pine oil containing product 1.0 BACKGROUND Purpose In this document, which is for use in EPA's development of the Pine Oil Reregistration Eligibility Decision Document ( RED), EPA presents the results of its review of the potential human health effects of occupational and residential exposure to pine oil.

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

1.1 Summary of Toxicity Concerns Relating to Exposures Endpoints of Concern Toxicological endpoints of concern for pine oil and associated uncertainty factors used in assessing the risks for pine oil are presented in Table 2. Page 4 of 17 Table 2. Pine Oil Hazard Endpoints and Uncertainty Factors Exposure Scenario Dose ( mg/ kg/ day) Endpoint Study Dietary Risk Assessment Acute Dietary ( general population) NOAEL = 50 UF = 100 Acute RfD = 0.05 mg/ kg/ d Maternal LOAEL of 600 mg/ kg/ d based on observed toxicity, decreased body weight, weight gain, food consumption developmental toxicity  rats Acute Dietary ( females 13+) NOAEL = 50 UF = 1000 Developmental toxicity LOAEL of 600 mg/ kg/ d based on decreased fetal weight, fetal malformations, retardation of ossification developmental toxicity  rats Chronic Dietary NOAEL = 50 UF = 3000 Chronic RfD = 0.016 mg/ kg/ d Maternal LOAEL of 600 mg/ kg/ d based on observed toxicity, decreased body weight, weight gain, food consumption developmental toxicity  rats Incidental Oral Short Term ( 1 30 days) NOAEL = 50 UF = 1000 developmental toxicity  rats Incidental Oral Intermediate Term ( 1 6 months) NOAEL = 50 UF = 3000 developmental toxicity  rats Non Dietary Risk Assessment Dermal Short term Endpoint not required Dermal Intermediate and Long Term NOAEL = 226 UF = 100 subchronic dermal toxicity  rats Inhalation All durations NOAEL = 50 UF = 1000 ( ST, IT) UF = 3000 ( LT) developmental toxicity  rats Notes: UF = uncertainty factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level, RfD = reference dose, MOE = margin of exposure Page 5 of 17 1.2 Summary of Use Pattern and Formulations Pine oil is the active ingredient in numerous formulations and is used as a disinfectant, sanitizer, microbicide/ microbistat, virucide, and insecticide. Products containing pine oil are designated for occupational and residential use. The occupational use sites include: eating establishments ( surfaces, equipment, and utensils), food processing plants/ areas, commercial/ institutional/ industrial premises and equipment, commercial transportation facilities, refuse and soil waste transportation and handling equipment, barber and beauty shop equipment and instruments, laundry, and hospitals and related institutions. The residential uses include: bathrooms, toilet bowls, kitchens, non porous surfaces, garbage cans, household items, laundry, and pets. A detailed listing of use sites for pine oil is presented in Appendix A.

Formulation Types and Percent Active Ingredient Concentrations of pine oil in products range from 80% to < 10%, with several ready to use products containing < 1% of the active ingredient. All formulations are in liquid form, and are generally intended to be diluted with water prior to use. Label instructions also indicate that products may be used full strength for heavy duty cleaning jobs or tough stains, but areas/ items should be rinsed with water after use immediately.

The Agency determines potential exposures to handlers of the product by identifying exposure scenarios from the various application methods that are plausible, given the label uses. Based on reviewing product labels, the following use patterns specific to pine oil are representative of the maximum potential exposures to pine oil:

Commercial Uses:

1. General cleansing of premises/ areas.

Residential Uses:

2. Cleansing bathroom/ kitchen areas, and 3. Washing a dog.

Pine oil is also available in a technical grade for reformulation and repackaging use. Products containing 99 to 100% pine oil are available to manufacturers for germicide and disinfectant production. Page 6 of 17 Daily Inhal Exposure mg AI day Inhal Unit Exposure mg AI lb AI Max Appl Rate lb AI Gal Max Volume Treated Gallons Day . . .. .

     =

     2.0 COMMERCIAL/ INSTITUTIONAL PREMISES ( HANDLER AND POSTAPPLICATION)

2.1 Occupational Handlers 2.1.1 Handler Exposures Scenarios Inhalation and dermal handler exposures were addressed for occupational populations using surrogate data from the Chemical Manufacturers Association ( CMA, 1992). Using surrogate unit exposure data, application rates from labels, and EPA estimates of daily amount handled, exposure and risks to handlers were assessed. The following handler exposure scenario has been identified:

° Handling pine oil containing cleaning products through low pressure spray, wipe, and mopping application methods.

While pine oil products have other listed uses, these additional exposure scenarios are not expected to result in higher exposures than the selected scenario. Therefore, exposures to pine oil from cleaning are considered representative of a high end exposure.

The exposure/ risks were calculated using the following equations.

The daily dermal exposures are calculated using the following formula:

Daily Dermal Exposure mg AI day Dermal Unit Exposure mg AI lb AI Max Appl Rate lb AI Gal Max Volume Treated Gallons Day

     =

     . . .

Potential daily inhalation exposures are calculated using the following formula:

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

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

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

( )      1 Page 7 of 17 Daily Inhalation Exposure mg day inhalation absorption inhalation tox study Body Weight kg ( / ) ( )

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

( / / ) Daily Inhalation Dose ( mg/ kg/ day) is calculated as:

Margin of Exposure ( MOE) is calculated by dividing the NOAEL or LOAEL by the daily dose.

The assumptions used in calculating the exposures/ risks are summarized in Table 3.

There are no chemical specific exposure data to assess cleaning product applications. Therefore, dermal and inhalation exposures were assessed for low pressure spray, wipe, and mopping application methods using surrogate data. Specifically, values from the Chemical Manufacturers Association ( CMA) antimicrobial study ( U. S. EPA, 1999) were used. The dermal and inhalation exposures from these techniques have been normalized by the amount of active ingredient handled and reported as unit exposures ( UE) expressed as mg/ lb ai handled. Specifically, it was assumed that occupational handlers will use 1.5 ounces of liquid pine oil containing product ( EPA Reg. No. 4313 9, 80% ai) diluted in 1 gallon of water for low pressure spray, wiping, and mopping application methods. Therefore, the use amount for the application of treated cleaning products is 0.08 lb ai/ gallon for the low pressure spray, wiping, and mopping application methods.

Using the assumptions discussed above, the calculated short and intermediate term aerosol generated inhalation and dermal MOEs, respectively, are 32,000 and 520 for the low pressure spray scenario, 2,500 and 270 for the wiping scenario, and 9,200 and 1,400 for the mopping scenario. The calculated MOEs indicate that the inhalation risks are not of concern for short and intermediate term durations for all uses. For dermal exposure, the calculated short and intermediate term MOEs indicate that the risks are not of concern for all uses.

The aerosol generated inhalation exposure and risk estimates from the CMA data discussed above do not account for the potential vapor inhalation exposure to pine oil ( pine oil has a relatively high vapor pressure). Therefore, the potential vapor inhalation exposure to handlers are addressed by modeling of the air concentrations. Because the occupational handlers use the same weight fraction of pine oil as the residential handlers, the same type of application techniques ( i. e., wipes, sprays, mop), and will clean in various rooms to accommodate the additional amount handled ( e. g., moving room to room in a hotel), the air concentrations and vapor generated inhalation risk estimates will be similar to those experienced by the residents presented in the residential section below. Based on these assumptions, the short and intermediate term vapor derived inhalation risks are not of concern ( i. e., MOE of 1,300 greater than the target MOE of 1000 for the average daily dose). Page 8 of 17 Table 3. Intermediate and Long term Risks Associated with Commercial/ Institutional Uses of Pine Oila Exposure Scenario Dermal Unit Exposure ( mg/ lb ai) b Inhalation Unit Exposure ( mg/ lb ai) c Appl. Rate d ( lb a. i./ gal) Amount of Product Handled Dermal Dose ( mg/ kg/ day) e Dermal MOE f Inhalation Dose ( mg/ kg/ day) g Inhalation MOE h Commercial/ Institutional Premises Cleaning products  Low pressure sprayer 191 0.681 0.08 2 gallons 0.44 520 0.0016 32,000 Cleaning products  Wiping 2870 67.3 0.08 1 liter 0.85 270 0.020 2,500 Cleaning products  Mopping 71.6 2.38 0.08 2 gallons 0.16 1,400 0.0054 9,200 a Handler is assumed to be wearing long pants, and long sleeved shirt. b Dermal unit exposures are from CMA study. c Inhalation unit exposures are from CMA study. d Application rates are based on the pine oil labels. e Dermal dose ( mg/ kg/ day) = [ unit exposure ( mg/ lb ai) * Appl. rate ( lb ai/ gallon) * gallons handled / Body weight ( 71.8 kg)]. f MOE = NOAEL ( mg/ kg/ day) / Daily Dose [ Where intermediate and long term dermal NOAEL = 226 mg/ kg/ day]. Target MOE is 100. g Inhalation dose ( mg/ kg/ day) = [ unit exposure ( mg/ lb ai) * max appl rate ( lb ai/ gal) * gallons handled * 1 inhalation absorption] / Body weight ( 70 kg). h MOE = NOAEL ( mg/ kg/ day) / Daily Dose [ Where short, intermediate, and long term inhalation NOAEL = 50 mg/ kg/ day]. Target MOE is 1000 for short and intermediate term exposure and 3000 for long term exposure.

2.2 Postapplication Exposure Occupational postapplication dermal and aerosol generated inhalation exposures to pine oil are likely to be minimal compared to handler exposure because of dilution with water. Therefore, a screeninglevel assessment was only conducted for the vapor inhalation exposure. The for potential short and intermediate term postapplication exposures to pine oil is based on the relatively high vapor pressure. Postapplication inhalation exposure is expected for bystanders remaining in areas of treatment. At this time, air concentration measurements taken after pine oil treatments are not available. In addition, modeled results for inhalation exposure are not specific for occupational postapplication uses. Therefore, the air concentration for the 80% product ( diluted in water to a weight fraction of 0.01) that was used in the EFAST model estimate listed in the residential handler section below is expected to yield similar results for bystanders. The average daily air concentration is 0.040 mg/ m3. Using an 8 hour workday, the dose is estimated to be 0.0057 mg/ kg/ day ( i. e., 0.040 mg/ m3 x 1.25 m3/ hr breathing rate x 8 hr/ day x ( 1/ 70 kg BW)). The short and intermediate term inhalation MOE is 8,800, and therefore, not of concern ( i. e., NOAEL of 50 mg/ kg/ day / 0.0057 mg/ kg/ day, target MOE = 1,000). Page 9 of 17 3.0 RESIDENTIAL AND PUBLIC ACCESS PREMISES ( HANDLER AND POSTAPPLICATION)

3.1 Residential Handlers Pine oil, found in many residential use products, is used as a cleaner, disinfectant, sanitizer, fungicide, mildewstat, and deodorizer.

For the purposes of this screening level assessment, handler scenarios have been developed that encompass multiple uses but still represent the high end scenario for all uses represented. Table 4 presents the residential handler scenarios considered in this assessment. Of the products containing pine oil, household cleaning products, which should yield the greatest amount of handler exposure to the chemical, was selected for analysis. Also, dog washing would be expected to be another use that may result in a high handler exposure.

Table 4. Residential Handler Scenarios Handler Scenario Products Represented Handling of liquid general purpose cleaner Household cleaning products Dog washing Household cleaning products with dog bathing applications 3.1.1 General Purpose Cleaner Scenario The following scenarios were considered for residential handlers of pine oil containing products:

° Use of cleaner/ disinfectant/ deodorizing wipe on hard non porous surfaces, ° Use of cleaner/ disinfectant/ deodorizing mopping on hard non porous surfaces, and ° Use of deodorizing dog wash.

These potential exposures from a general purpose cleaner are expected to be best represented by the short term duration. However, because no dermal endpoint has been identified for the pine oil shortterm duration ( i. e., not of concern) the risks for the intermediate term duration have been presented to bracket the potential risks. The dermal portion of the risks presented ( as opposed to short term inhalation) should not be included into the aggregate risk because they are not believed to be representative of the pine oil use pattern.

Inhalation and dermal exposures were addressed for residential handlers using surrogate data from the Chemical Manufacturers Association ( CMA, 1992). Using surrogate unit exposure data, application rates from labels, and EPA estimates of daily amount handled, exposure and risks to residential handlers were assessed. In addition, pine oil has a relatively high vapor pressure ( 0.2 mmHg @ 20 C), and therefore, also presents a concern for potential vapor inhalation exposure. To determine the Page 10 of 17 potential inhalation exposure resulting from the vapor of pine oil, the model EFAST ( Exposure and Fate Assessment Screening Tool) was used to estimate the air concentration. OPPT/ EETD has developed the model, EFAST, to estimate air concentrations. More information and access to the EFAST model is available at http:// www. epa. gov/ opptintr/ exposure/. In summary, EFAST Version 1.0 bases its air concentration estimates on physical/ chemical properties. The air concentration estimates for the pine oils are based on the model's standard input parameters. The following information is presented in the EFAST model:

".... it is assumed to contact the target surface, and to subsequently volatilize at a rate that depends upon the chemical's molecular weight and vapor pressure."

EFAST presents a peak air concentration as well as a daily air concentration. The peak air concentration estimate "... is the highest instantaneous air concentration that is modeled during the exposure event." This peak air concentration is not expected for any appreciable length of time.

As previously discussed, 1.5 ounces of liquid pine oil containing product ( 80% ai EPA Reg. No. 4313 9) diluted in 1 gallon of water has been identified for wiping, and mopping application methods. Therefore, the use amount for the application of treated cleaning products is 0.08 lb ai/ gallon for the wiping and mopping application methods. CMA data were used to determine the unit dermal and inhalation exposures. The no gloved CMA unit exposure data for wiping and mopping were used to determine the dermal and inhalation exposure. It was assumed that 0.5 liter is used for wiping and 1 gallon for mopping. The 0.5 liter assumption for the wipes is a screening level estimate and should be refined by the registrant.

The results of the MOE analysis from the CMA data for these scenarios are presented in Table 5. The calculated dermal MOEs ( intermediate term) are not of concern for any of the scenarios ( MOE = 530 and 2,800, for wiping and mopping, respectively). The intermediate term dermal risks are presented to bracket the potential risks as there are no short term dermal toxicological concerns The calculated inhalation MOEs ( all durations) for the wiping is of concern using the CMA data because the estimated MOE of 500 is below the target MOE for 1,000. The inhalation MOE ( all durations) for mopping from the CMA data is not of concern ( MOE = 19,000). Refinements to the amount of wipes handled on a daily basis should be submitted by the registrant. EFAST indicates a peak concentration of 4.38 mg/ m3 from this activity. Because the peak concentration does not represent a daily inhalation exposure, the daily dose rather than the peak estimate from EFAST is used to compare to the inhalation toxicological endpoint, representing all durations. If a short term toxicological endpoint of less than one day were to be generated it should be compared to the peak air concentration estimate. However, because the toxicological endpoint of concern is based on greater than one day of exposure, the daily dose rate of 0.040 mg/ kg/ day from EFAST is used in this assessment. The daily dose rate is based on the average daily concentration of 0.22 mg/ m3. The results of the EFAST model indicate a short term inhalation MOE from the vapor of pine oil to be 1,300. Therefore, the vapor inhalation portion of pine oil is not of concern ( i. e., above the target MOE of 1,000). Page 11 of 17 Table 5. Calculation of Dermal and Inhalation MOE for Residential Handlers a Exposure Scenario Method of Applicatio n Dermal Unit Exposure ( mg/ lb ai) b Inhalation Unit Exposure ( mg/ lb ai) c Appl. Rate d ( lb a. i./ gal) Amount Treated Absorbed Dermal Dose ( mg/ kg/ day ) f Dermal MOE g Inhalation Dose ( mg/ kg/ day) h Inhalatio n MOE i Hard Surface Disinfection Wipes 2870 ( CMA no glove) 67.3 ( CMA) 0.08 0.5 liter of product ( 0.13 gal) 0.43 530 0.10 500 Mopping 71.6 2.38 0.08 1 gallons 0.08 2,800 0.0027 19,000 a MOEs rounded to 2 significant figures. b Dermal unit exposures are from CMA. c Inhalation unit exposures are from CMA. d Application rates are based on the pine oil labels. f Dermal dose ( mg/ kg/ day) = [ unit exposure ( mg/ lb ai) * Appl. rate ( lb ai/ gallon) * gallons handled / Body weight ( 70 kg). g Dermal MOE = NOAEL ( mg/ kg/ day) / Daily Dose [ Where intermediate term dermal NOAEL = 226 mg/ kg/ day]. Target MOE is 100. Note: No short term toxicological concern. h Inhalation dose ( mg/ kg/ day) = [ unit exposure ( mg/ lb ai) * max appl rate ( lb ai/ gal) * gallons handled * 1 inhalation absorption] / Body weight ( 70 kg). i Inhalation MOE = NOAEL ( mg/ kg/ day) / Daily Dose [ NOAEL for all durations = 50 mg/ kg/ day]. Target MOE is 1000 for short and intermediate term.

3.1.2 Dog Bath Residential exposure to pine oil products used for washing dogs ( i. e., specified on label as a " dog bath") is believed to be best represented by the short term exposure duration. Therefore, because a short term dermal endpoint was not identified ( i. e., determined not to be of concern) no estimates are presented for the dermal exposure to homeowners bathing a dog ( dog shampoo exposure estimates are very crude and therefore not presented to bracket the risks for the intermediate term duration). However, a short term inhalation endpoint has been identified for pine oil. The methodology outlined in the Standard Operating Procedures ( SOPs) for Residential Exposure Assessments ( U. S. EPA 2000) for calculating handler inhalation doses from treating pets with shampoo is based on a percentage of the application rate. Because pine oils have a relatively high vapor pressure, the model EFAST was used. However, EFAST does not contain an exposure scenario for bathing a dog. Therefore, to determine the potential inhalation exposure to pine oil when used to bath a dog, the air concentration estimate for general purpose cleaners was used. The application rate for a dog bath ( EPA Reg. No. 62644 1) is 3 teaspoons of a 19.9 % ai formulation per gallon of water. Therefore, the weight fraction is determined to be 0.00078 ( i. e., 3 tsp/ 768 tsp per gallon x 8 lb/ gal x 0.199 = 0.0062 lb ai per gallon of dog bath. Weight fraction is 0.0062 lb ai per gallon / 8 lb per gallon wash solution density = 0.00078). The weight fraction used in the general purpose cleaner assessment above was 0.01. Therefore, the estimated inhalation risk for the dog bath is less than that posed by the cleaner use ( i. e., higher MOE than the 1,300 estimated above) and not of concern. Page 12 of 17 3.2 Residential Postapplication Exposure Post application exposures can occur to toddlers from the dermal, oral ( incidental) and inhalation routes from floors that have been mopped with a product containing pine oil. Additionally, adults may be exposed to inhalation exposures after this use Although residential floors are believed to be washed/ moped on an intermittent basis ( perhaps weekly), facilities such as day care centers may clean the floors more often. Therefore, the intermediate term dermal risks have been presented ( no shortterm dermal endpoints of concern). In addition, both the short and intermediate term incidental oral endpoints are provided to assess the potential risks. The short and intermediate term inhalation exposure to vapors of pine oil after treatment are also of potential concern. Finally, there is also the potential exposure to toddlers playing/ sleeping with treated dogs. The duration of exposure is expected to be short term because of the intermittent bathing of dogs and the relatively high vapor pressure of pine oil. Although there is no dermal endpoint of concern for the short term duration, inhalation exposure and risks are presented.

Dermal Exposure There is the potential for dermal exposure to toddlers crawling on the floor. To determine toddler exposure to residues on treated floor, the following equation was used:

PDD FR x SA BW =

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

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

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

$ 1.5 ounces of liquid pine oil containing product diluted in 1 gallon of water is used for mopping. Additionally, based on the label for EPA Registration Nos. 4313 9, it is assumed that products containing 80% a. i. are used per gallon of water. Therefore, the use amount for the application of treated cleaning products is 0.08 lb ai/ gallon, and that the resulting solution is applied at a rate of 1000 sq. ft. per gallon. ° No data could be found regarding the quantity of solution residue left on the floor after treatment. As a conservative measure, it has been assumed that 25% of the cleaner remains after the final mopping. Page 13 of 17 ° No transferable residue data were available that could be used to estimate the skin transfer of pine oil from the floor. Therefore, Residential SOPs estimate of 10% of the amount on the hard surface is available for dermal transfer.

The calculation of the dermal dose and the dermal MOE are presented in Table 7. The dermal MOE is estimated to be 530 which is above the target MOE of 100, and therefore not of concern.

Table 7. Intermediate term Dermal Risks Associated with Postapplication Dermal Exposure on Treated Floors.

Parameter Value Rationale Application Rate 1000 ft2/ gallon of solution USEPA Assumption Cleaning Solution 0.08 lb ai/ gallon Maximum rate listed on label ( EPA Reg. No. 4313 9)

Transferable Residues ( TR) 9.8 mg/ m2/ day (( 0.08 lb ai/ gal)/( 1000ft2 per gallon)) * ( 25% remaining)* ( 10% transfer) * ( Conversion Factors)

Surface Area of Body in Contact with Carpet 0.657 m2 Median surface area of toddler Body Weight 15 kg Median body weight of toddler Potential Dermal Exposure 0.43 mg/ kg/ day TR * SA/ BW Dermal NOAEL 226 mg/ kg/ day Dermal MOE 530 ( Derm. NOAEL) / ( Daily Derm. Dose). Target MOE = 100.

TR = [(( 0.08 lb ai/ gal / 1000ft2) x ( 454 gr/ lb) x ( 1000 mg/ gr) x ( 1 ft2 / 0.093 m2)) x ( 0.25 remaining) x ( 0.1 transferable)]

Incidental Ingestion In addition to dermal exposure, infants crawling on treated floors will also be exposed to pine oils via incidental oral exposure. To calculate incidental ingestion exposure to pine oils due to hand to mouth transfer, the scenarios established in the Standard Operating Procedures ( SOPs) for Residential Exposure Assessments were used. These scenarios use assumptions that are similar to those used in calculating exposures due to dermal contact of pine oils from toddlers crawling on treated floors. The assumptions above in the dermal assessment ( Table 7) estimates the transferable residues as 0.98 µ g/ cm2 ( equivalent to 9.8 mg/ m2). The estimated potential ingestion dose rate immediately after application would be calculated as follows:

PDR norm= ISR t x SA x FQ x SE x ET x 0.001 mg/ µ g BW where: Page 14 of 17 PDR norm = Potential dose rate ( mg/ kg/ day); ISR t = Indoor Surface Residue ( µ g/ cm2) at time 0; SA = Surface area of the hands that contact both the treated area, and the individuals mouth ( cm2/ event); FQ = Frequency of hand to mouth events ( events/ hr); SE = Saliva extraction efficiency of 50%; and, ET = Exposure Time ( 4 hrs/ day) BW = Body weight ( 15 kg)

The surface area used for each hand to mouth event is 20 cm2. It is assumed that there are 20 handto mouth exposure events per hour ( 90th percentile) for short term duration and 9.5 events per hour for intermediate term duration ( mean). The short term incidental oral NOAEL of 50 mg/ kg/ day ( target MOE = 1,000) is believed to best represent the homeowner uses because of the intermittent nature of cleaning the floor and the intermediate term duration best represents uses in day care centers. The intermediate term incidental oral NOAEL is the same but the target MOE is 3,000. The potential dose rate ( PDR) using this equation for short term exposure is 0.05 mg/ kg/ day and 0.025 mg/ kg/ day for intermediate term exposure, resulting in a hand to mouth short term MOE for toddlers of 1,000 and an intermediate term MOE of 2000. Therefore, the incidental oral exposure is only of concern for the intermediate term duration ( i. e., below the target MOE of 3,000 for intermediate term).

Inhalation Exposure Postapplication inhalation exposure to adults and toddlers after pine oil use ( as a general cleaner and/ or dog bath) is concern because of the relatively high vapor pressure of pine oil ( i. e., 0.2 mm Hg @ 20C). No postapplication air concentration data have been submitted to determine potential inhalation risk. Therefore, EFAST was used to present a screening level estimate of the potential inhalation risk. The inhalation toxicological endpoint represents both the short and intermediate term exposure durations. The postapplication estimates are based on the EFAST results for the air concentration and inhalation dose from the adult handlers. The toddler risk estimates are corrected for the lower body weight ( i. e., 15 kg).

EFAST was used to model the air concentration from general purpose cleaners using a weight fraction of 0.01 ( i. e., 1 percent). EFAST indicates a peak concentration of 4.38 mg/ m3 from this activity. Because the peak concentration does not represent a daily inhalation exposure, the daily dose rather than the peak estimate from EFAST is used to compare to the short term inhalation toxicological endpoint. If an acute ( less than one day) toxicological endpoint were to be generated it should be compared to the peak air concentration estimate. However, because the toxicological endpoint of concern is based on greater than one day of exposure, the daily dose rate of 0.040 mg/ kg/ day from EFAST is used in this assessment for adults and 0.19 mg/ kg/ day for toddlers ( i. e., 0.04 mg/ kg/ day x 71.8 kg adult BW x ( 1/ 15 kg toddler BW). The daily dose rate is based on the average daily concentration of 0.22 mg/ m3. The inhalation MOE for adults is not of concern ( i. e., MOE = NOAEL of 50 mg/ kg/ day / 0.04 mg/ kg/ day = 1,300, target MOE of 1,000). However, based on the same scenario, the toddler short term inhalation risk is of concern because of the difference in body weight ( i. e., MOE = NOAEL of 50 mg/ kg/ day / 0.19 mg/ kg/ day = 260, target MOE of 1,000). The risks for the toddlers were scaled by body weight but not breathing rate. The breathing rate of a toddler is lower than that of an adult, and therefore, the MOEs would be slightly higher, but not above Page 15 of 17 the target MOE of 1,000. EFAST was also used to estimate the potential inhalation risks resulting from the treatment of dogs. Although EFAST does not provide a scenario for pets, it does provide a screening level assessment for cleaning products. Based on the cleaning product scenario and a weight fraction of 0.00078 ( pine oil dog wash solution concentration), the acute dose rate is 0.0068 mg/ kg/ day. The short term inhalation MOE is 7,400 which is not of concern ( short term target MOE is 1,000).

4.0 LIMITATIONS AND UNCERTAINTIES There are a number of uncertainties associated with this assessment. In general, extremely conservative values were used in cases where data were lacking. Assessments for these scenarios should be considered as screening assessments, and not indicative of the true risk associated with these scenarios.

° Surrogate dermal and inhalation data from the limited data available in the Chemical Manufacturers Association ( CMA) database were used to assess handler exposure.

° Very little data could be found regarding typical amounts handled by workers in commercial/ institutional premises or by residential applicators. Refinements to the amount handled should be submitted by the registrant. Page 16 of 17 5.0 REFERENCES USEPA. 1997. Exposure Factors Handbook. Volume I II. Office of Research and Development. Washington, D. C. EPA/ 600/ P 95/ 002Fa.

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

USEPA. 2000. Residential SOPs. EPA Office of Pesticide Programs   Human Health Division. Dated April 5, 2000. Page 17 of 17 APPENDIX: Use Sites for Pine Oil in Product Indoor Food Eating Establishments ( Food Contact) Eating Establishments Equipment and Utensils ( Food Contact) Food Processing, Handling and Storage Plants/ Areas Meat Processing Plants Poultry Meat Processing Plants Indoor Non Food Eating Establishments ( Non Food Contact) Commercial, Institutional and Industrial Areas/ Premises Commercial, Institutional and Industrial Equipment Commercial Transportation Facilities ( Non Food Contact) Laundry Equipment Diapers ( Commercial Laundry) Refuse and Solid Waste Transportation and Handling Equipment Hard Non Porous Surface Treatments Farm Animals ( All or Unspecified) Automobiles and Ships Indoor Residential Household or Domestic Dwellings Household or Domestic Dwelling Contents Bathroom Premises Human Bedding Human Grooming Instruments Laundry ( Household/ Coin Operated) Refuse and Solid Waste Containers ( Garbage Cans) Refuse and Solid Waste Sites Refuse and Solid Waste Transportation and Handling Equipment Hard Non Porous Surface Treatments Toilet Bowls and Urinals Pets ( All or Unspecified)


[Federal Register Volume 83, Number 150 (Friday, August 3, 2018)]
[Rules and Regulations]
[Page 38036]
[FR Doc No: C1-2018-15718]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 63

[EPA-HQ-OAR-2016-0442; FRL-9981-06-OAR]
RIN 2060-AS92

National Emission Standards for Hazardous Air Pollutants From the
Portland Cement Manufacturing Industry Residual Risk and Technology
Review

Correction

    In rule document 2018-15718 beginning on page 35122 in the issue of
Wednesday, July 25, 2018, make the following correction:

Table 1 to Subpart LLL of Part 63 [Corrected]

0
On page 35135, the table should read as set forth below:

                     Table 1 to Subpart LLL of Part 63--Applicability of General Provisions
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                Citation                       Requirement        Applies to subpart LLL        Explanation
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                                                  * * * * * * *
63.10(e)(3)(v).........................  Due Dates for Excess                         No   Sec.   63.1354(b)(9)
                                          Emissions and CMS                                 specifies due date.
                                          Performance Reports.

                                                  * * * * * * *
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[FR Doc. C1-2018-15718 Filed 8-2-18; 8:45 am]
 BILLING CODE 1301-00-D


[Federal Register Volume 88, Number 29 (Monday, February 13, 2023)]
[Notices]
[Pages 9312-9313]
[FR Doc No: 2023-02985]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Docket No. FAA-2022-1605]

Agency Information Collection Activities: Requests for Comments;
Clearance of a New Approval of Information Collection: International
Role of the Federal Aviation Administration

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval for a new information collection.
The collection involves questioning, via email, telephone or other
means, foreign entities to determine what collaborative opportunities
exist. The information to be collected is necessary to accomplish the
statutory requirements to ``provide technical assistance on any other
aspect of aviation safety that the Administrator determines is likely
to enhance international aviation safety.'' The information collection
will also inform the FAA's International Strategy, which is the
agency's mechanism for fulfilling its international role. The
information collection directly supports the International Strategy by
enabling the FAA to reshape and further strengthen its longstanding
international contributions.

DATES: Written comments should be submitted by April 11, 2023.

ADDRESSES: Please send written comments:
    By Electronic Docket: www.regulations.gov (Enter docket number into
search field).

    By Mail: Nicholas DeLotell, Office of International Affairs, 800
Independence Ave. SW, Washington, DC 20591.
    By Fax:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Nicholas DeLotell by email at:
[email protected]; phone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.
    OMB Control Number: 2120-XXXX.
    Title: Agency Information Collection Activities: Requests for
Comments; Clearance of a New Approval of Information Collection:
International Role of the Federal Aviation Administration.
    Form Numbers: None.
    Type of Review: Clearance of a new information collection.
    Background: 49 U.S.C. 40104 requires ``the Administrator to promote
and achieve global improvements in the safety, efficiency, and
environmental effect of air travel by engaging with foreign
counterparts, in the International Civil Aviation Organization (ICAO)
and its subsidiary organizations, and other international organizations
and fora, and with the private sector.'' The statute further requires
the Administrator to engage bilaterally and multilaterally on an
ongoing basis to bolster international collaboration and to harmonize
international aviation safety requirements, and to expand the technical
assistance provided by the FAA in support of enhancing international
aviation safety.
    This information collection specifically facilitates work and
training arrangements with foreign counterparts, ICAO and its
subsidiary organizations, other international organizations and fora,
and with private entities around the world; it identifies opportunities
and unexpected changes; and it ultimately contributes to the
fulfillment of the FAA's mission to provide the safest, most efficient
aerospace system in the world.
    Foreign affairs specialists assigned to the FAA Office of
International Affairs will collect information from respondents
(foreign counterparts, ICAO and its subsidiary organizations, other
international organizations and fora, or from private foreign entities)
verbally, in-person or telephonically, or in writing via letter, email,
or other electronic means.
    Respondents: You are asked to comment on any aspect of this
information collection, including (a) whether the proposed collection
of information is necessary for FAA's performance; (b) the accuracy of
the estimated burden; (c) ways for FAA to enhance the quality, utility
and clarity of the information collection; and (d) ways that the burden
could be minimized without reducing the quality of the collected
information. The agency will summarize and/or include your comments in
the request for OMB's clearance of this information collection.
    Frequency: The FAA estimates this collection of information would
result in approximately twenty instances of international technical
assistance per year.
    Estimated Average Burden per Response: Given unique requirements
the FAA and respondents may have, and the ongoing dialog necessary to
conduct work with foreign entities, the FAA estimates a cumulative
burden of approximately 4 hours per response.
    Estimated Total Annual Burden: We estimate 20 responses per year at
an average of 4 hours per response, for a total annual hourly burden of
80 hours. We found that these activities are typically performed by the
respondents' equivalent to a FAA foreign affairs specialist, for which
the FAA assumes a mid-grade GS-13 salary, Rest of USA locality. Annual
salary is $106,955, divided by 2,080 hours for an hourly rate of
$51.42. The FAA uses a fringe benefits and overhead cost, for FAA
employees, of 100%. This results in a fully loaded wage of $102.84 per
hour. The total hourly burden of 80 multiplied by the fully loaded
hourly rate of $102.84 results in an annual economic burden of
$8,227.20.

    Issued in Washington, DC, on February 7, 2023.
India Pinkney,
Executive Director, Office of International Affairs.
[FR Doc. 2023-02985 Filed 2-10-23; 8:45 am]
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