PINE OIL Risk Assessment Office of Pesticide Programs Antimicrobials Division U. S. Environmental Protection Agency 1801 South Bell Street Arlington, VA 22202 September 8, 2004 1.0 EXECUTIVE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 2.0 PHYSICAL/ CHEMICAL PROPERTIES CHARACTERIZATION . . . . . . . . . . . . 9 2.1 Chemical Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 2.2 Physical/ Chemical Properties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 3.0 HAZARD CHARACTERIZATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 3.1 Hazard Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 3.2 FQPA Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 3.3 Dose Response Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 3.4 Endocrine Disruption . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 4.0 EXPOSURE ASSESSMENT AND CHARACTERIZATION . . . . . . . . . . . . . . . . . 15 4.1 Summary of Registered Uses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 4.2 Dietary Exposure/ Risk Pathway . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 4.3 Drinking Water Exposure/ Risk Pathway . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 4.4 Residential Exposure/ Risk Pathway . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 4.4.1 Residential Handler Scenarios . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 <IP_ADDRESS>General Purpose Cleaner Scenario . . . . . . . . . . . . . . . . . . . . . 18 <IP_ADDRESS>Dog Bath . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 4.4.2 Residential Postapplication Exposure . . . . . . . . . . . . . . . . . . . . . . . . 20 5.0 AGGREGATE RISK ASSESSMENTS AND RISK CHARACTERIZATION . . . 24 5.1 Acute and Chronic Dietary Aggregate Risk. . . . . . . . . . . . . . . . . . . . . . . . . . . 24 5.2 Short, Intermediate, and Long Term Aggregate Risk. . . . . . . . . . . . . . . . . .24 5.3 Dermal Aggregate Risk. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 6.0 OCCUPATIONAL EXPOSURE AND RISK . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 6.1 Occupational Handlers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 6.2 Occupational Postapplication Exposure . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 7.0 INCIDENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 8.0 ENVIRONMENTAL FATE ASSESSMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 9.0 ECOTOXICOLOGY ASSESSMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 10.0 REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 Page 3 of 34 Page 4 of 34 1.0 EXECUTIVE SUMMARY Pine Oil is a complex combination of terpenes produced by high temperature distillation of oil of turpentine or by catalytic hydration of terpenes. Pine oil contains a minimum of 60% isomeric secondary and tertiary cyclic terpene alcohols and a maximum of 40% non terpene alcohol components consisting of terpene hydrocarbons, terpene ether, and ketones.

Pine Oil is registered for use as a disinfectant, sanitizer, microbiocide/ microbiostat, virucide, and insecticide for indoor food use, indoor non food use, indoor residential use, indoor medical use, and aquatic non food industrial use. Some of these formulations are allowed for use as hard surface disinfectants in eating establishments where there may be the potential for indirect transfer to food.

Hazard: The acute toxicity of pine oil is relatively low by the oral route ( Toxicity Category III), dermal route ( Toxicity category III), and inhalation route ( Toxicity category IV). Pine oil is a moderate skin irritant ( Toxicity category III), but shows a stronger response as an eye irritant ( Toxicity category II).

Subchronic toxicity testing of pine oil in rats showed no systemic toxicity by the dermal route ( 90 day dermal toxicity study). No studies are available regarding subchronic toxicity by the oral route. The Agency recommends that a subchronic oral toxicity study with neurotoxicity evaluation be performed for adequate evaluation of the hazard from repeated oral exposure.

In a developmental toxicity study in rats, maternal toxicity was observed at doses of 600 and 1,200 mg/ kg/ day. Maternal deaths at the dose level of 1,200 mg/ kg/ day indicated a potential neurotoxic effect. In fetuses, increased fetal and litter incidence of depressed eye bulge were observed at the 1,200 mg/ kg/ day dose. Dilation of the lateral ventricles was present at 1,200 mg/ kg/ day, and increased incidence of micropthalmia was also noted. Increased fetal and litter incidence of non ossified or incompletely ossified skull, vertebrae, manubrium, sternebrae, and pelvis were also reported in the study. The maternal and developmental toxicity NOAEL for this study is 50 mg/ kg/ day. This value is considered somewhat conservative based on the lack of any other studies available for non acute toxicity of pine oil.

Toxicity Endpoints: The toxicity endpoints used in this document to assess potential risks include acute and chronic dietary reference doses ( RfDs), short and intermediate term incidental oral dose, intermediate and long term dermal dose and short, intermediate, and longterm inhalation dose. These endpoints were selected in 2004 by the Antimicrobials Division's Toxicology Endpoint Selection Committee ( ADTC) for use as appropriate in occupational/ residential exposure assessments.

Acute and Chronic RfDs: The aRfD for females of child bearing age ( 13 50 years) and the general population is 0.05 mg/ kg/ day. The female ( 13 50 year) aRfD is based on adverse developmental effects ( decreased fetal weight, fetal malformations, retardation of ossification) at Page 5 of 34 600 mg/ kg/ day in the rat developmental study, while the aRfD for the general population is based on clinical observations of toxicity, decreased body weight, weight gain, food consumption in maternal rats at 600 mg/ kg/ day in the same study. Uncertainty factors were included for interspecies extrapolation ( 10x), intra species variation ( 10x), and lack of an adequate hazard database ( 10x).

The chronic RfD is 0.016 mg/ kg/ day based on adverse maternal effects at 600 mg/ kg/ day in the rat developmental study. Uncertainty factors were included for inter species extrapolation ( 10x), intra species variation ( 10x), lack of an adequate hazard database ( 10x), and lack of a long term study ( 3x).

Incidental oral endpoints: The short term, and intermediate term incidental oral endpoint of 50 mg/ kg/ day is based on clinical observations of toxicity, decreased body weight, weight gain, and food consumption at 600 mg/ kg/ day in maternal animals in the rat developmental study. Uncertainty factors were included for inter species extrapolation ( 10x), intra species variation ( 10x), lack of an adequate hazard database ( 10x), and lack of a long term study ( 3x; intermediate term endpoint only). Thus, the target margin of exposure ( MOE) is 1,000 for shortterm exposures and 3,000 for intermediate term exposures.

Dermal endpoints: A short term dermal endpoint was not needed for pine oil. This conclusion was based on the results of a 14 day dermal toxicity study ( submitted with the 90 day dermal toxicity study) in which no adverse dermal effects were observed at a dose near a limit dose ( 940 mg/ kg/ day). For intermediate and long term dermal exposure, the highest dose tested in the 90 day dermal toxicity study was selected as the endpoint ( NOAEL of 226 mg/ kg/ day). Uncertainty factors were used for inter species extrapolation ( 10x) and intra species variation ( 10x). The target MOE is 100. Although this study is not acceptable by OPP's published guidelines, extra uncertainty factors were not applied to the endpoint based on the conservative nature of the dose level ( i. e. 226 mg/ kg/ day vs. 940 mg/ kg/ day in the 14 day dermal study) and the observation that higher dose levels could not be tested dermally Inhalation endpoints: The inhalation endpoint for all exposure durations is 50 mg/ kg/ day and is based on clinical observations of toxicity, decreased body weight, weight gain, and food consumption at 600 mg/ kg/ day in maternal animals in the rat developmental study. Uncertainty factors were included for inter species extrapolation ( 10x), intra species variation ( 10x), and lack of an adequate hazard database including a route specific inhalation study ( 10x) for the short term inhalation endpoint. For the intermediate and long term endpoint, an additional uncertainty of 3x was applied for the lack of a long term study from which to determine a long term exposure endpoint. Thus, the MOE is 1,000 for short and intermediate term exposures and 3,000 for longterm exposures.

FQPA Safety Factor: On February 24, 2004 , the ADTC reviewed the available toxicology data for pine oil and recommended that the hazard based special FQPA safety factor be reduced ( 1X) when assessing dietary risks resulting from the uses of pine oil. The ADTC also concluded that there is no evidence for susceptibility to exposure to pine oil from the limited data available. Page 6 of 34 1 PAD = Population Adjusted Dose = Acute or Chronic RfD FQPA Safety Factor Based on Agency policy, a RfD modified by a FQPA safety factor is a population adjusted dose ( PAD) 1. The Agency calculated an acute PAD and a chronic PAD, and uses this value to estimate acute and chronic dietary risk. The acute PAD is the acute RfD divided by the FQPA safety factor. The chronic PAD is the chronic RfD divided by the FQPA safety factor.

Dietary Exposure and Risk: AD considered potential dietary exposure to pine oil residues in food. When assessing acute and chronic ( non cancer) dietary risk, AD considered potential dietary exposure to the U. S. population including infants and children as well as to females 13 50 years, based on the developmental toxicity potential of this active ingredient. AD expresses dietary risk estimates as a percentage of the aPAD or chronic PAD. Dietary exposures that are less than 100% of the aPAD or cPAD are below the Agency's level of concern.

Several registered product labels exist in which pine oil is used as a disinfectant in restaurants, kitchens, cafeteria, food storage areas, counter tops, stove tops, drain boards, microwaves, food processing plants, and picnic tables. The Agency did not request nor was any data received on the residue chemistry of pine oil. Therefore, the Agency has relied upon the models developed by the Food and Drug Administration ( FDA) to estimate dietary exposure through the indirect food contact uses of pine oil. The results of the dietary exposure and risk analysis indicated that of the five product formulations registered for indirect food uses, two formulations indicated risks of concern for adults and children where dietary exposure exceeded 100% of the aPAD and cPAD. The acute dietary risk estimates ranged from 7 to 400% of the aPAD, while the chronic dietary risk estimates ranged from 21 to 1,250% of the cPAD. The highest dietary risk estimates are for children.

Water Exposure and Risk: Pine Oil is registered for indoor uses only and it is not likely to contaminate surface or ground water. In an event, however, if Pine oil is released to a waste stream, the three major constituents namely: alpha pinene, beta pinene and alpha terpineol volatilize rapidly from surface water, are highly biodegradable, they have short half lives in water, and have low mobility in soils. Hence there is low probability of surface and ground water contamination.

Residential ( Non Occupational) Exposure and Risk: Pine oil, found in many residential use products, is used as a cleaner, disinfectant, sanitizer, fungicide, mildewstat, and deodorizer. The handler scenarios used in the residential exposure assessment were developed to encompass multiple uses but still represent a high end exposure scenario for all uses represented. The residential handler scenarios considered in this assessment include handling of liquid general purpose cleaner and dog bathing. These scenarios were selected because they are believed to yield the greatest amount of handler exposure to pine oil. Page 7 of 34 For the general purpose cleaner scenario, the calculated dermal MOEs are not of concern for any of the scenarios ( MOE = 530 and 2,800, for wiping and mopping, respectively). The calculated inhalation aerosol MOE for the wiping is of concern because the estimated MOE of 500 is below the target MOE for 1,000. The inhalation aerosol MOE for mopping is not of concern ( MOE = 19,000). Refinements to the amount of wipes handled on a daily basis should be submitted by the registrant. In addition, inhalation MOEs from the vapor of pine oil are not of concern ( MOE 1,300).

Residential exposure to pine oil products used for washing dogs ( i. e., specified on label as a " dog bath") was also evaluated. This scenario is believed to be best represented by the shortterm exposure duration. Because there is no short term dermal endpoint, dermal risks were not evaluated. However, a short term inhalation exposure and risks to pine oil vapors were estimated using 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 as a screening level assessment. 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 for the general purpose cleaner assessment above was higher   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 for vapor exposures) and not of concern.

The residential post application scenario considered in this assessment is exposure to residue from hard surfaces ( i. e., floors) that have been mopped with a product containing pine oil. At this time the Antimicrobials Division has not developed a methodology to assess exposure to pets after treatment. This is considered a data gap that needs to be addressed by the registrant.

Dermal and incidental oral exposures of toddlers crawling on floors treated with pine oil products were assessed as part of the post application exposure and risk assessment. The dermal MOE from this scenario ( 530) does not indicate a risk of concern for toddlers ( target MOE

100). However, the short and intermediate term incidental oral MOEs for toddlers are 1,000 and 2,000, respectively ( target MOE

1000 for short term and 3000 for intermediate term). Therefore, only the intermediate term incidental oral MOE is of concern ( i. e., less than the target MOE of 3000).

In addition, short term postapplication inhalation exposures to vapors are not of concern for adults for cleaning products ( MOE= 1,300 versus target MOE

1000), but are of concern for children ( MOE = 260) for the 80% ai cleaning products. However, the postapplication inhalation ( vapor) MOE for the dog bathing scenario is below the Agency's level of concern ( MOE= 7,400 Page 8 of 34 versus target MOE of

1000).

Aggregate Exposure and Risk: For the short term aggregate assessment, adult exposures from dietary exposure and cleaning could be aggregated. In the case of pine oil, the dietary exposure is aggregated with the inhalation exposures from cleaning. The dermal exposure is not included as the study and endpoint defining the toxicity by the dermal route differ from the oral and inhalation route.

For toddlers, only the short term incidental oral exposure from the floor cleaning ( postapplication) are aggregated with dietary exposure. Dermal exposures are not aggregated for the same reason as stated for adults. In addition, there are no aggregate intermediate term scenarios for toddlers, although there are intermediate term exposure scenarios.

The Aggregate Risk Index ( ARI) method is used to aggregate the above scenarios, as the uncertainty factor from chronic dietary exposure ( 3000) is dissimilar to the uncertainty factors for the short and intermediate term inhalation exposure ( 1000). Based on this approach, the ARI for adult males ranged from 0.21 0.45, for adult females 0.19 0.44, and for children 0.06 0.2, which are below the target ARI of

1, and thus, exceed the Agency's level of concern.

Occupational Exposure and Risk: Worker exposure to pine oil is expected to occur through the use of pine oil containing products in commercial/ institutional settings ( e. g., janitors). Dermal and inhalation exposures from contact with pine oil were assessed for handling pine oilcontaining 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 was considered representative of a high end exposure.

Occupational handler exposures were assessed for low pressure spray, wipe, and mopping application methods using surrogate data obtained from the Chemical Manufacturers Association ( CMA) antimicrobial study ( U. S. EPA, 1999). In addition, product label maximum application rates, related use information, and Agency standard values were used to evaluate occupational handler exposures. The dermal and inhalation risk estimates for all 3 scenarios are not of concern ( dermal MOEs range from 270 to 2,900 and the inhalation MOEs range from 2,500 to 32,000, with target MOEs of 100 and 1,000, respectively).

Occupational postapplication dermal and aerosol and vapor generated inhalation exposures to pine oil are likely to be minimal compared to handler exposure because of dilution with water. ( Note: postapplication exposure from cleaning products are assessed for residents in the residential section.) Therefore, a separate screening level assessment was not conducted for occupational postapplication scenarios.

Environmental Fate: No data are available regarding the fate characteristics of pine oil, which is a complex mixture of terpenes. The fate properties of the major components of pine oil, namely alpha terpineol and alpha and beta pinene, were used instead to assess the environmental fate of this complex blend. Based on alpha and beta pinene's bioconcentration factors of 2,800 Page 9 of 34 and 440, respectively, and high log K ow values, bioaccumulation or bioconcentration in aquatic organisms is possible. Likewise, alpha terpineol's bioconcentration factor of 110 suggests that the potential for bioconcentration is high while a log K ow of 2.98 indicates potential to moderately bioaccumulate. However, alpha and beta pinene are expected to undergo rapid biodegradation and volatilization in water. Alpha terpineol, on the other hand, does not seem to biodegrade and volatilize as rapidly as alpha and beta pinene.

Alpha / beta pinene and alpha terpineol have been shown to be readily biodegradable in soil by microorganisms. In addition, the Henry's Law Constants for these chemicals indicate that they will volatilize from most moist soils. However, they are expected to absorb with a high degree to suspended particles and sediments in the water column based on estimated K oc values ( 1,000 for alpha pinene and alpha terpineol and 1,200 for beta pinene).

In general, the rapid volatilization and biodegradation and low half lives in water of alpha / beta pinene and alpha terpineol indicate a low probability for contamination of water systems. Due to their volatilization, biodegradation and low mobility in soils, contamination of ground or surface water systems is not likely.

Ecotoxicology: Ecological effects data indicate that pine oil is practically non toxic to avian species and only slightly toxic to freshwater fish and invertebrates on an acute basis. Chronic toxicity testing for freshwater organisms is not required for pine oil and no information is currently available. Likewise, plant toxicity information on pine oil is not available; however, terrestrial and aquatic plant testing is not required to support the indoor uses of pine oil.

DATA GAPS / REQUIREMENTS For the uses of Pine Oil in the RED, data gaps exist for a two generation reproduction toxicity test, a 90 day oral toxicity test with neurotoxic endpoint evaluation, and a 90 day oral dog study because of the indirect food uses for phenol. These aspects of Pine oil toxicity are not adequately addressed by the current toxicology database, and uncertainty factors have been used in the absence of these data.

In addition, the dermal sensitization assay and the in vitro mammalian cells in culture assay must be repeated. The sensitization assay used an inadequate number of animals to make a determination of sensitization, and the CHO assay had significant problems with the integrity of the cell cultures that compromised the results of the study.

The residential post application scenario considered in this assessment is exposure to residue from hard surfaces ( i. e., floors) that have been mopped with a product containing pine oil. At this time the Antimicrobials Division has not developed a methodology to assess exposure to pets after treatment. This is considered a data gap that needs to be addressed by the registrant Page 10 of 34 2.0 PHYSICAL/ CHEMICAL PROPERTIES CHARACTERIZATION 2.1 Chemical Identification Chemical identification parameters, including chemical and common/ trade names, chemical family, CAS Number, and molecular formula are provided in Table 1.

Table 1. Chemical Identification Chemical Name 1 Methyl 4 isopropyl 1 cyclo hexen 8 ol Common/ Trade Names Pine Oil 80 Chemical Family alpha Terpineol and Terpinolene ( Terpene alcohol)

CAS Number 8002 09 3 Molecular Formula C10H18O 2.2 Physical/ Chemical Properties The physical and chemical properties of Pine oil are shown in Table 2.

Table 2. Physical/ Chemical Properties Parameter Value Molecular Weight 154.0 Color Colorless to pale yellow Physical State Liquid Specific gravity 0.952 at 20 oC Boiling Point ~ 210 o C at 750 mm Hg Dissociation Constant NA ( insoluble in water)

pH NA ( insoluble in water)

Stability 30 day accelerated storage study showed the substance is stable Melting point N/ A Water Solubility Insoluble in water ( immiscible)

Solubility in organic solvents Isopropyl alcohol > 90% Toluene > 90%

Octanol water Partition Coefficient Can not be determined ( insoluble in water)

Vapor Pressure 0.2 mm Hg at 20

C Page 11 of 34 3.0 HAZARD CHARACTERIZATION 3.1 Hazard Profile A detailed hazard assessment for pine oil is presented in the attached appendix ( Toxicology Disciplinary Chapter for the Reregistration Eligibility Decision Document, May 2004).

Acute Toxicity. In acute toxicity studies, pine oil has been shown to have low toxicity by the oral route ( Toxicity Category III), inhalation route ( Toxicity Category IV) and dermal route ( Toxicity Category III). Pine oil is a moderate skin irritant ( Toxicity Category III), but shows a stronger response as an eye irritant ( category II). No dermal sensitization has been observed with pine oil; however, the available dermal sensitization assay is considered unacceptable because an inadequate number of animals was used to make the determination of sensitization. Table 3 presents the acute toxicity data for pine oil. Table 4 highlights results of key toxicological studies with pine oil.

Subchronic Toxicity. The database for subchronic toxicity of pine oil consists of one 14 day dermal toxicity test and one 90 day dermal toxicity test in rats. In the 14 day dermal toxicity test no significant adverse effects were observed up to a dose of 940 mg/ kg/ day. In the 90 day dermal toxicity study, no significant adverse dermal or systemic effects were observed due to treatment. The systemic no observed adverse effect level ( NOAEL) was

226 mg/ kg/ day ( the highest dose tested); a lowest observable adverse effect level ( LOAEL) could not be determined due to a lack of treatment related effects.

Developmental Toxicity. In a prenatal developmental toxicity study in rats, maternal toxicity in the form of excess salivation, alopecia, and ungroomed coat was observed at doses of 600 and 1,200 mg/ kg/ day. In addition, adrenal gland weight was significantly increased in maternal animals at the 1,200 mg/ kg/ day dose level. Maternal deaths were also increased at the 1,200 mg/ kg/ day; animals exhibited ataxia, decreased motor activity, and impaired righting reflex prior to death, raising the possibility of a neurotoxic effect. External examination of fetuses showed an increased fetal and litter incidence of depressed eye bulge at the 1,200 mg/ kg/ day dose. Visceral examination showed dilation of the lateral ventricles at 1,200 mg/ kg/ day, and increased incidence of micropthalmia. Skeletal examination showed increased fetal and litter incidence of non ossified or incompletely ossified skull, vertebrae, manubrium, sternebrae, and pelvis. The maternal and developmental toxicity NOAEL for this study is 50 mg/ kg/ day. This value is considered somewhat conservative based on the lack of any other available studies for non acute toxicity of pine oil.

Reproductive Toxicity. Studies with pine oil were not available to satisfy the data requirements for reproductive toxicity for this chemical. As there are indirect food uses for this chemical, and in accordance with the interim working policy of AD regarding indirect food use data requirements, a reproductive toxicity study is required in order to properly characterize these risks. Page 12 of 34 Carcinogenicity. Pine oil has not been classified as to its carcinogenicity. However, carcinogenicity data are not required at this time.

Mutagenicity. Acceptable mutagenicity studies including Ames Salmonella assay and micronucleus assay were conducted with pine oil. No mutagenic response was observed in these studies. In an unacceptable in vitro cytogenetics assay, a negative mutagenic response was also observed for this chemical. This study was deemed unacceptable due to problems with the integrity of the cell cultures.

Neurotoxicity. Studies with pine oil were not available to satisfy the data requirements for neurotoxicity for this chemical. The Agency recommends that a subchronic oral toxicity study with neurotoxicity evaluation be perform to address the neurotoxicty of pine oil.

Metabolism. Metabolism data are not required at this time.

Table 3. Acute Toxicity of Pine Oil Guideline No./ Study Type MRID No. Results Toxicity Category 870.1100 Acute oral toxicity Rat 40253502 LD50( combined) = 2.7 g/ kg III 870.1200 Acute Dermal toxicity Rat 40253503 LD50 > 2000 mg/ kg III 870.1300 Acute inhalation toxicity Rat 43375208 LC50 > 3.67 mg/ L IV 870.2500 Dermal irritation Rabbit 43375210 Erythema/ edema up to 7 days post dose III 870.2400 Primary Eye Irritation 43375209 Irritation lasting up to 16 days II 870.2600 Skin sensitization Guinea pig Not a sensitizer. Study unacceptable Table 4. Toxicity Profile of Pine Oil Guideline No./ Study Type MRID No. ( year)/ Classification/ Doses Results 870.3250 90 day Dermal Toxicity in Rats 40515401 ( 1988)/ Unacceptable/ Doses: 0, 50, 113, 226 mg/ kg/ day to shaved skin, 6 hrs/ day, 5days/ wk, 13 weeks Systemic Toxicity NOAEL = > 226 mg/ kg/ day Systemic Toxicity LOAEL = > 226 mg/ kg/ day NOAEL can be estimated from a 14 day range finding study that showed a dermal NOAEL of 940 mg/ kg/ day. Page 13 of 34 Table 4. Toxicity Profile of Pine Oil Guideline No./ Study Type MRID No. ( year)/ Classification/ Doses Results 870.3700 Developmental Toxicity in Rats 40515201 ( 1988)/ Acceptable guideline/ Doses: 0, 50, 600, 1200 mg/ kg/ day Maternal/ Developmental Toxicity NOAEL = 50 mg/ kg/ day Maternal/ Developmental Toxicity LOAEL = 600 mg/ kg/ day The dose spacing in this study ( i. e. 50, 600, 1,200 mg/ kg/ day) along with the appearance of effects mainly at 1200 but also at 600 mg/ kg/ day suggests that effects could have arisen at doses lower than 1,200 mg/ kg/ day but greater than 600 mg/ kg/ day. This leads to a conservative assumption of 50 mg/ kg/ day as the NOAEL for maternal and developmental toxicity.

Mutagenicity Gene Mutation 870.5100 Ames Salmonella Assay 43375212 ( 1994)/ Acceptable/ concentrations of 0.1, 1.0, 10, 100, 1,000, 10,000  g/ plate No evidence of an increase in induced mutant colonies over background in the absence or presence of metabolic activation.

In vitro Cytogenetics 870.5300 40341403 ( 1987)/ Unacceptable/ 100, 130, 170, 200, 250 ng/ mL ( S9); 50, 100, 200, 300, 400 nL/ mL (+ S9) No evidence of induction of mutant colonies over background. Study not acceptable and must be repeated. Cells not checked for mycoplasma contamination, and several cultures were lost to contamination during conduct of the assay.

870.5395 Micronucleus Assay 40341403 ( 1987)/ Acceptable/ i. p. doses of 0, 116, 578, 1155 mg/ kg No significant increase in frequency of micronucleated polychromatic erythrocytes in bone marrow at any test concentration or harvest time.

Neurotoxicity 870.6300 Developmental neurotoxicity Not required 3.2 FQPA Considerations Under the Food Quality Protection Act ( FQPA), P. L. 104 170, which was promulgated in 1996 as an amendment to the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) and the Federal Food, Drug and Cosmetic Act ( FFDCA), the Agency was directed to " ensure that there is a reasonable certainty that no harm will result to infants and children" from aggregate exposure to a pesticide chemical residue. The law further states that in the case of threshold effects, for purposes of providing this reasonable certainty of no harm, " an additional tenfold Page 14 of 34 margin of safety for the pesticide chemical residue and other sources of exposure shall be applied for infants and children to take into account potential pre and post natal toxicity and completeness of the data with respect to exposure and toxicity to infants and children. Notwithstanding such requirement for an additional margin of safety, the Administrator may use a different margin of safety for the pesticide residue only if, on the basis of reliable data, such margin will be safe for infants and children."

On February 24, 2004 , the Antimicrobials Division Toxicology Endpoint Selection Committee ( ADTC) reviewed the available toxicology data for pine oil and recommended that the hazard based special FQPA safety factor be removed ( 1x) when assessing dietary risks resulting from the uses of pine oil. This conclusion is based on the use of conservative NOAEL values from the developmental toxicity study for calculation of dietary and non dietary endpoints. The ADTC also concluded that there is no evidence for susceptibility to exposure to pine oil from the limited data available.

3.3 Dose Response Assessment The doses and toxicological endpoints selected for various exposure scenarios are summarized in Table 5.

Table 5. Toxicological Endpoints Exposure Scenario Dose used in risk assessment UF / MOE FQPA SF and Endpoint for Risk Assessment Study and Toxicological Effects Dietary Risk Assessments Acute Dietary ( gen pop) NOAEL of 50 mg/ kg/ day UF= 100 DB= 10X Acute RfD = 0.05 mg/ kg/ day FQPA SF = 1x aPAD= acute RfD FQPA = 0.05 mg/ kg/ day Developmental toxicity study in rats Maternal LOAEL of 600 mg/ kg/ day based on clinical observations of toxicity, decreased body weight, weight gain, food consumption Acute Dietary ( females 13+) NOAEL of 50 mg/ kg/ day UF= 100 DB= 10X Acute RfD = 0.05 mg/ kg/ day FQPA SF = 1x aPAD= acute RfD FQPA = 0.05 mg/ kg/ day Developmental toxicity study in rats Developmental toxicity LOAEL of 600 mg/ kg/ day based on decreased fetal weight, fetal malformations, retardation of ossification. Page 15 of 34 Table 5. Toxicological Endpoints Exposure Scenario Dose used in risk assessment UF / MOE FQPA SF and Endpoint for Risk Assessment Study and Toxicological Effects Chronic Dietary NOAEL= 50 UF= 300 DB= 10X Chronic RfD = 0.016 mg/ kg/ day FQPA SF = 1x cPAD= chronicRfD FQPA = 0.016 mg/ kg/ day Developmental toxicity study in rats Maternal LOAEL of 600 mg/ kg/ day based on clinical observations of toxicity, decreased body weight, weight gain, food consumption Non Dietary Risk Assessments Incidental Oral Short   and Intermediate Term ( 1  30 Days, and 1 6 months) Maternal NOAEL= 50 mg/ kg/ day Target MOE= 1,000 ( short term) 3,000 ( intermediateterm Developmental toxicity study in rats Maternal LOAEL of 600 mg/ kg/ day based on clinical observations of toxicity, decreased body weight, weight gain, food consumption Dermal Short  term Endpoint not required Dermal intermediate and long term Dermal NOAEL > 226 mg/ kg/ day Target MOE= 100 ( residential and occupational) 90 day dermal toxicity study in rats Dermal NOAEL of > 226 mg/ kg/ day ( highest dose tested)

Inhalation All durations NOAEL = 50 mg/ kg/ day ( assume inhalation and oral absorption are equivalent, i. e., 100%) Target MOE = 1,000 ( ST, IT)

= 3,000 ( LT)

( residential and occupational Developmental toxicity in rats Maternal LOAEL of 600 mg/ kg/ day based on clinical observations of toxicity, decreased body weight, weight gain, food consumption.

Notes: UF = uncertainty factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level, RfD = reference dose, MOE = margin of exposure A short term dermal endpoint was not needed for pine oil. This conclusion was based on the results of a 14 day dermal toxicity study ( submitted with the 90 day dermal toxicity study) in which no adverse dermal effects were observed at a dose near a limit dose ( 940 mg/ kg/ day).

Database Uncertainty Factor. Based on the lack of specific neurotoxicity endpoints and a reproductive toxicity study, a database uncertainty factor of 10x applies to pine oil for residents and workers for oral and inhalation exposures. Page 16 of 34 3.4 Endocrine Disruption The Agency is required under the Federal Food, Drug and Cosmetic Act ( FFDCA), as amended by FQPA, to develop a screening program to determine whether certain substances ( including all pesticide active and other ingredients) " may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or other such endocrine effects as the Administrator may designate." Following the recommendations of its Endocrine Disruptor Screening and Testing Advisory Committee ( EDSTAC), EPA determined that there was scientific bases for including, as part of the program, the androgen and thyroid hormone systems, in addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation that the Program include evaluations of potential effects in wildlife. For pesticide chemicals, EPA will use FIFRA and, to the extent that effects in wildlife may help determine whether a substance may have an effect in humans, FFDCA authority to require the wildlife evaluations. As the science develops and resources allow, screening of additional hormone systems may be added to the Endocrine Disruptor Screening Program ( EDSP).

4.0 EXPOSURE ASSESSMENT AND CHARACTERIZATION 4.1 Summary of Registered Uses 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 locations include: bathrooms, toilet bowls, kitchens, non porous surfaces, garbage cans, household items, laundry, and pets.

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 immediately.

4.2 Dietary Exposure/ Risk Pathway Several registered product labels exist in which pine oil is used as a disinfectant in restaurants, kitchens, cafeteria, food storage areas, counter tops, stove tops, drain boards, microwaves, food processing plants, and picnic tables. The Agency did not request nor was any data received on the Page 17 of 34 residue chemistry of pine oil. Therefore, the Agency has relied upon the models developed by the Food and Drug Administration ( FDA) to estimate dietary exposure through the indirect food contact uses of pine oil. In estimating the dietary exposure from the disinfectant use of pine oil, the Agency has made the following assumptions:

1. Residual solution of the formulation on Surface: 1 mg/ cm2 ( FDA's worst Case scenario and EPA also has used this assumption)

2. Area of treated surface: 2000 cm2 ( 50% of the FDA worst case assumption, and EPA also has used this assumption)

3. EPA is making the assumption that in all scenarios listed for the product labels, the maximum exposure of food ( indirect contact) is 2000 cm2, including drain boards.

4. The Agency recognizes that as a disinfectant use, there will be a potable water rinse following application of the disinfectant. Although there are quantitative approaches to measuring the reduction in residue, the Agency has assumed a 90% reduction in residue level as reasonable. Hence the dietary exposure risk assessment is carried out based on the 90% reduction scenario.

Estimation of dietary exposure for the registered pine oil formulation taking into account the above assumptions yielded exposure estimates from 0.0034 0.0448 mg/ kg/ day for adult males, 0.0039 0.0523 mg/ kg/ day for adult females, and 0.0158 0.2 mg/ kg/ day for children ( 15kg). The exposure estimates and resulting dietary risk are summarized in the following table:

Dietary Exposure and Risk Formulation Exposure ( mg/ kg/ day) ( males) % aPAD % cPAD Lonza P 13 0.007 14 44 Lonza P 6 0.0035 7.0 22 Lonza P 39 0.0034 7.0 21 El Pinol 60 0.0448 90 280 El Pinol 19.9 0.0175 35 109 Formulation Exposure ( mg/ kg/ day) ( females) % aPAD % cPAD Lonza P 13 0.0081 16 50 Lonza P 6 0.0041 8.2 25 Lonza P 39 0.0039 8.0 24 Page 18 of 34 El Pinol 60 0.0523 104 326 El Pinol 19.9 0.0205 41 128 Page 19 of 34 Formulation Exposure ( mg/ kg/ day) ( child) % aPAD % cPAD Lonza P 13 0.032 64 200 Lonza P 6 0.0164 33 102 Lonza P 39 0.0158 32 99 El Pinol 60 0.2 400 1250 El Pinol 19.9 0.082 164 512 As is observed from the above calculations, three of the formulas do not present any dietary risk to adults or children, but two of the formulations ( El Pinol 60 and El Pinol 19.9) present a risk of concern to all populations studied. The acute dietary risk estimates ranged from 7 to 400% of the aPAD, while the chronic dietary risk estimates ranged from 21 to 1,250% of the cPAD. The highest dietary risk estimates are for children.

4.3 Drinking Water Exposure/ Risk Pathway Pine Oil is registered for indoor uses only and it is not likely to contaminate surface or ground water. In an event, however, if Pine oil is released to a waste stream, the three major constituents namely: alpha pinene, beta pinene and alpha terpineol volatilize rapidly from surface water, are highly biodegradable, they have short half lives in water, and have low mobility in soils. Hence there is low probability of surface and ground water contamination.

4.4 Residential Exposure/ Risk Pathway A detailed residential and occupational risk assessment for pine oils is provided in the attached Appendix. A summary of the exposures and risks to residential handlers is provided below.

4.4.1 Residential Handler Scenarios Pine oil, found in many residential use products, is used as a cleaner, disinfectant, sanitizer, fungicide, mildewstat, and deodorizer. The handler scenarios used in the residential exposure assessment were developed to encompass multiple uses but still represent a high end exposure scenario for all uses represented. The residential handler scenarios considered in this assessment include handling of liquid general purpose cleaner and dog washing. These scenarios were selected because they are believed to yield the greatest amount of handler exposure to pine oil. Page 20 of 34 <IP_ADDRESS> General Purpose Cleaner Scenario The following two scenarios were considered for residential handlers of pine oil containing cleaning products:

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

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 short term duration ( i. e., short term dermal risks are not of concern) the risks for the intermediate term duration have been presented to bracket the potential risks for the regulatory managers. 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.

An application rate of 1.5 ounces of liquid pine oil containing product diluted in 1 gallon of water has been identified for wiping, and mopping application methods ( EPA Reg. No. 4313 9). The 80% ai product is the highest percent ai formulation found, there are, however, many other labels with lower ai percentages. The dilution rate 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 inhalation portion of the exposure from CMA is not the vapor phase but rather resulting from aerosols/ splashing of liquid. 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.

Because pine oil has a relatively high vapor pressure ( 0.2 mmHg @ 20 C), there is also the concern for potential vapor inhalation exposure. To determine the 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. 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.

EFAST was used to model the air concentration from general purpose cleaners using a weight fraction of 0.01 for the pine oil cleaning solution/ water ( 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 a short term toxicological Page 21 of 34 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 MOE analysis for these scenarios are presented in Table 6. 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 short term inhalation MOEs from the CMA data for the wiping is of concern because the estimated MOE of 500 is below the target MOE for 1,000. This estimate is based on the 80 percent active ingredient. The risks for the lower percent active ingredient formulations of pine oil will be proportional to the percent active ingredient. The inhalation MOE from the CMA data for mopping is not of concern ( MOE = 19,000). The results of the EFAST model exposure of 0.040 mg/ kg/ day indicate an inhalation MOE ( all exposure durations) 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).

Table 6. Calculation of Dermal and Inhalation MOEs based on CMA Data for Residential Handlers a Exposure Scenario Method of Applicati on 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 ( aerosol) ( mg/ kg/ day) ( h Inhalatio n ( aerosol) 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 gallon 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 Intermediate term Dermal MOE = NOAEL ( mg/ kg/ day) / Daily Dose [ Where intermediate term dermal NOAEL = 226 mg/ kg/ day]. Target MOE is 100. Note: Short term not of 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 = LOAEL ( mg/ kg/ day) / Daily Dose [ LOAEL for all durations = 50 mg/ kg/ day]. Target MOE is 1000 for short and intermediate term. Page 22 of 34 <IP_ADDRESS> 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 as a screening level assessment. 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 for the general purpose cleaner assessment above was higher   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.

4.4.2 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 short term dermal endpoints of concern). In addition, both the short and intermediate term incidental oral endpoints are provided to assess the potential risks. The shortand 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 intermediate term dermal exposure to toddlers crawling on the floors where cleaning occurs more often than in a residence, such as at day care facilities. To determine toddler exposure to residues on treated floor, the following equation was used: Page 23 of 34 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. ° 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 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 Page 24 of 34 Table 7. Intermediate term Risks Associated with Postapplication Dermal Exposure on Treated Floors.

Parameter Value Rationale 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:

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 hand to mouth exposure events per hour ( 90th percentile) for the short term duration and 9.5 events per hour for the 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 the short term exposure is 0.05 mg/ kg/ day and 0.025 mg/ kg/ day for the intermediate term, resulting in a hand to mouth short term MOE for toddlers of 1,000 and 2,000 for the intermediate term. Therefore, the Page 25 of 34 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 Post application inhalation exposure to adults and toddlers after pine oil use ( as a general cleaner and/ or dog bath) is of 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 with the same target MOE of 1,000. The exposure pattern is believed to be of a short term duration. The post application 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 ( vapors) from general purpose cleaners using a weight fraction of 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 vapor 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 inhalation vapor 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).

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), 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). Page 26 of 34 5.0 AGGREGATE RISK ASSESSMENTS AND RISK CHARACTERIZATION In order for a pesticide registration to continue, it must be shown that the use does not result in " unreasonable adverse effects on the environment". Section 2 ( bb) of FIFRA defines this term to include " a human dietary risk from residues that result from a use of a pesticide in or on any food inconsistent with standard under section 408..." of FFDCA. Consequently, even though no pesticide tolerances have been established for pine oils, the standards of FQPA must still be met, including " that there is reasonable certainty that no harm will result from aggregate exposure to pesticide chemical residue, including all anticipated dietary exposures and other exposures for which there are reliable information." Aggregate exposure is the total exposure to a single chemical ( or its residues) that may occur from dietary ( i. e., food and drinking water), residential, and other non occupational sources, and from all known or plausible exposure routes ( oral, dermal, and inhalation).

5.1 Acute and Chronic Dietary Aggregate Risk Aggregate dietary risk includes exposure from food and drinking water. Pine oil is used as a hard surface disinfectant, and dietary exposures from the use of the five products have been noted above in the dietary exposure and risk section. Pine oil is not expected to impact drinking water from the registered uses as noted above. With respect to the five pine oil formulations noted in the dietary exposure and risk section of this chapter, only the El Pinol 19.9 and El Pinol 60 formulations show a dietary risk of concern for chronic exposure in adults and children. One other formulation ( Lonza P 6) shows some risk of concern for children ( 102% of the cPAD) but this value is close to 100% of the cPAD and thus is in actuality not interpreted as a risk of concern. The other estimations of dietary risk are interpreted as conservative and would likely be lower with additional data on residue levels after use of these formulations.

5.2 Short, Intermediate, and Long Term Aggregate Risk In accordance with the policy of the Office of Pesticide Programs, short, intermediate, and long term risk typically involves exposure from dietary sources ( food and water) in combination with residential scenarios that have a reasonable chance of co occurrence. In the case of pine oil, residential scenarios are not felt to be long term exposures, only short term and sometimes intermediate term. Thus, there is no long term aggregate risk assessment.

For the short term aggregate assessment, adult exposures from diet and cleaning could be aggregated. In the case of pine oil, the dietary exposure is aggregated with the inhalation exposures from cleaning as the study and endpoint describing the effects from these two routes of exposure was the same. The dermal exposure is not included as the study and endpoint defining the toxicity by the dermal route differ from the oral and inhalation route.

For toddlers, dietary exposure is aggregated with the incidental oral exposure from the floor cleaning. Dermal exposures are not aggregated for the same reason as stated for adults. In addition, there are no aggregate intermediate term scenarios for toddlers, although there are intermediate term exposure scenarios. Page 27 of 34 The Aggregate Risk Index method is used to aggregate the above scenarios, as the uncertainty factor for the chronic dietary endpoint ( 3000) is dissimilar to the uncertainty factor for the short and intermediate term inhalation exposure ( 1000). Thus, ratios of MOE/ UF are calculated to yield a risk index ( RI) for each scenario aggregated, which can then be inserted into the equation:

ARI = 1 1 + 1 + .... 1 RI 1 RI 2 RI n The result is compared against the number 1. ARIs greater than 1 indicate no risk of concern while values less than 1 indicate the potential for risk. Using the results of the dietary exposure estimations for the five pine oil formulations in combination with the inhalation exposures as noted above for adults and toddlers, the following results are obtained:

Aggregate Short term Risks for Adult Males Dietary exposure Diet MOE1 Diet MOE/ UF2 Inhalation exposure3 ( mg/ kg/ day) Inhalation MOE Inhalation MOE/ UF ARI 0.007 7142 2.4 0.1 500 0.5 0.41 0.0035 14285 4.7 0.45 0.0034 14705 4.9 0.45 0.0448 1116 0.37 0.21 0.0175 2857 0.95 0.33 1Diet MOE = short term incidental oral NOAEL / food exposure 2MOE/ UF = calculated MOE / chronic dietary UF [ 3000] 3inhalation exposure from cleaning product ( wiping).

Aggregate Short term Risks for Adult Females Dietary exposure ( mg/ kg/ day) Diet MOE1 Diet MOE/ UF2 Inhalation exposure3 ( mg/ kg/ day) Inhalation MOE Inhalation MOE/ UF ARI 0.0081 6172 2.0 0.1 500 0.5 0.40 0.0041 12195 4.0 0.44 0.0039 12820 4.3 0.44 Page 28 of 34 Aggregate Short term Risks for Adult Females Dietary exposure ( mg/ kg/ day) Diet MOE1 Diet MOE/ UF2 Inhalation exposure3 ( mg/ kg/ day) Inhalation MOE Inhalation MOE/ UF ARI 0.0523 956 0.32 0.19 0.0205 2439 0.81 0.31 1Diet MOE = short term incidental oral NOAEL / food exposure 2MOE/ UF = calculated MOE / chronic dietary UF [ 3000] 3inhalation exposure from a cleaning product ( wiping)

Aggregate Short term Risks for Children/ toddlers Dietary exposure Diet MOE1 Diet MOE/ UF2 Inhalation exposure3 ( mg/ kg/ day) ( MOE) MOE/ UF Incidental Oral exposure4 ( mg/ kg/ day) , ( MOE), MOE/ UF ARI 0.032 1562 0.52 0.19 260 0.26 0.05 1000 1.0 0.17 0.0164 3048 1.0 0.2 0.0158 3164 1.0 0.2 0.2 250 0.08 0.06 0.082 609 0.2 0.11 1Diet MOE = short term incidental oral NOAEL / food exposure 2MOE/ UF = calculated MOE / chronic dietary UF [ 3000] 3inhalation post application exposure from cleaning product 4Incidental oral exposure from treated floors The above calculations show ARIs of less than 1 for adults and children/ toddlers. As shown, the ARI for adult males ranged from 0.21 0.45, for adult females 0.19 0.44, and for children 0.06 0.2, which are below the target ARI of

1, and thus, exceed the Agency's level of concern. For adult residential handlers, the inhalation exposures during cleaning are a significant contributor to the aggregate risks of concern. This is because, this scenario alone, also exceeds the Agency's level of concern ( MOE= 500, versus target MOE

1000). In addition, the dietary risk estimates for two of the disinfectant products also contribute significantly to the aggregate risk estimates, since these risks are also of concern alone (% cPAD 109 326%).

Children's/ toddlers calculated ARI values are lower than the adult values. The postapplication exposure from the 80% ai cleaning product is a primary driver for the risk estimate Page 29 of 34 derived here, except when the dietary estimate from the El Pinol formulations contributes significantly to the ARI value.

5.3 Dermal Aggregate Risk Dermal exposures are considered short term only except for the toddler dermal scenario from crawling on treated floors. For pine oil, no short term dermal endpoint was identified in the available toxicology database. As there is only one quantified dermal scenario, no aggregation of dermal exposure is performed for pine oil.

6.0 OCCUPATIONAL EXPOSURE AND RISK A detailed residential and occupational risk assessment for pine oils is provided in the attached Appendix. A summary of the exposures and risks to occupational handlers is provided below.

6.1 Occupational Handlers The handlers were identified as those individuals who use pine oil containing products in commercial/ institutional setting ( including industrial and medical uses). The following short and intermediate term handler exposure scenario was evaluated for pine oil:

° 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 would be considered representative of a high end exposure.

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. In addition, product label maximum application rates, related use information, and Agency standard values were used to assess occupational handler exposures. Specifically, it was assumed that occupational handlers will use 1.5 ounces of liquid pine oil containing 80% product 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. For spraying and mopping it is assumed that 2 gallons ( each) are used for daily cleaning and that 1 liter is used for wiping.

The results of the MOE analysis are presented in Table 9. The calculated MOEs indicate that aerosol generated inhalation exposure risks are not of concern ( i. e., MOEs

1,000) for short Page 30 of 34 and intermediate term exposures under all scenarios assessed. For dermal exposure, the calculated MOEs indicate that risks do not exceed the Agency's level of concern for the low pressure spray and mopping scenarios ( i. e., MOE > 100), but exceed the level of concern for wiping.

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. 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).

Table 9. Estimates of Exposure and Risks to Primary Occupational Handlers of Pine Oil Exposure Scenario Dermal Dose ( mg/ kg/ day) a Inhalation Dose ( mg/ kg/ day) b Dermal MOE c Inhalation MOE d Cleaning products  Low pressure sprayer 0.44 0.0016 520 32,000 Cleaning products  Wiping 0.85 0.020 270 2,500 Cleaning products  Mopping 0.16 0.0054 2,900 9,200 a Abs. Dermal Dose ( mg/ kg/ day) = [ Appl. rate ( lb ai/ gallon) * Gallons handled * Unit Exposure ( mg/ lb ai)] / Body Weight ( 70 kg)]. Clothing attire is long pants, long sleeved shirts, and no gloves. b Inhalation Dose ( mg/ kg/ day) = [ Appl. rate ( lb ai/ gallon) * Gallons handled * Unit Exposure ( mg/ lb ai) * 1 Inhalation Absorption] / Body Weight ( 70 kg). c Dermal MOE= Dermal NOAEL ( 226 mg/ kg/ day)/ Dermal Dose ( mg/ kg/ day). Target MOE is 100. d Inhalation MOE= Inhalation NOAEL ( 50 mg/ kg/ day)/ Inhalation Dose ( mg/ kg/ day). Target MOE is 1,000 for shortand intermediate term exposure.

6.2 Occupational 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 screening level assessment was not conducted for these occupational postapplication scenarios. Any residential postapplication exposure resulting from the occupational/ commercial treatments ( e. g., cleaning of day care centers) are assessed in the residential section above.

There is, however, the for potential short and intermediate term postapplication exposures to pine oils based on the relatively high vapor pressure. Postapplication inhalation exposure is expected for bystanders remaining in areas of treatment. At this time, air concentration Page 31 of 34 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 above 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., LOAEL of 50 mg/ kg/ day / 0.0057 mg/ kg/ day, target MOE = 1,000).

7.0 INCIDENTS The main routes of exposure reported in incident reports are oral, dermal, and inhalation. Ingestion incidents have occurred due to: people have mistaking a container of pine oil as something drinkable, people trying to commit suicide, or people using a product for its alcohol content. Thirty one cases of ingestion were found in the databases, 7 of which resulted in death. Dermal exposure causes irritation, rash, and allergic reaction. Inhalation exposures cause respiratory symptoms   shortness of breath, etc. Ocular exposure causes imitation and blurred vision. There was nothing in the databases regarding chronic effects, and no evidence of delayed toxicity. Only a small fraction of the cases involved something serious enough to involve medical attention.

8.0 ENVIRONMENTAL FATE ASSESSMENT No submitted data or open literature are available regarding the fate characteristics of pine oil, which is a complex mixture of terpenes produced by high temperature distillation of oil of turpentine or by catalytic hydration of terpenes. The fate properties of the major components of pine oil, namely alpha terpineol and alpha and beta pinene, were used instead to assess the environmental fate of this complex blend. Environmental fate properties of these three components are shown in Table 9. Alpha and beta pinene's bioconcentration factors of 2,800 and 440, respectively, and high log K ow values suggest that bioaccumulation or bioconcentration in aquatic organisms is possible. Likewise, alpha terpineol's bioconcentration factor of 110 suggests that the potential for bioconcentration is high while a log K ow of 2.98 indicates potential to moderately bioaccumulate. However, a recent paper by the National Park Service of Colorado and Colorado State University indicates that turpentine oil ( of which alpha/ beta pinenes constitute up to 90%) does not appear to bioaccumulate possibly due to the fact that turpentine oil is highly biodegradable ( Roy Erwin, National Park Service, Water Resource Division, Fort Collins, Colorado, July 1997). Both, alpha and beta pinene undergo rapid biodegradation in water as indicated by aqueous aerobic degradation studies. Estimated volatilization half lives for alpha and beta pinene are 4 hours and 1.2 hours, respectively, in a model river. Alpha terpineol, on the other hand, does not seem to biodegrade as rapidly as alpha/ beta pinene. Estimated half life for alphaterpineol is 4 days in a model river.

Alpha / beta pinene and alpha terpineol have been shown to be readily biodegradable in soil by microorganisms. In addition, the Henry's Law Constants for these chemicals indicate that they will volatilize from most moist soils. However, they are expected to absorb with a high degree to Page 32 of 34 suspended particles and sediments in the water column based on estimated K oc values ( 1,000 for alpha pinene and alpha terpineol and 1,200 for beta pinene).

In general, the rapid volatilization and biodegradation and low half lives in water of alpha / beta pinene and alpha terpineol indicate a low probability for contamination of water systems. Due to their volatilization, biodegradation and low mobility in soils, contamination of ground or surface water systems is not likely.

Table 10. Environmental Fate Properties of Alpha and Beta Pinene and Alpha Terpineol Parameter Alpha Pinene Beta Pinene Alpha Terpineol Vapor Pressure @ 25C ( mm Hg) 4.75 2.93 0.0423 Henry's Law Constant ( air/ water partition coefficient) ( atm cu m/ mole) 0.107 0.16 1.2x10 5 KOC ( organic carbon ratio in soil) 1000 1200 1000 Log KOW ( octanol/ water partition coefficient 4.83 4.35 2.98 BCF 2800 440 110 9.0 ECOTOXICOLOGY ASSESSMENT Environmental Modeling/ Exposure Environmental exposure modeling was not conducted for the indoor uses of Pine Oil considered in this RED. Environmental exposure is not expected to result when registered products are used according to label directions.

Ecological Hazard and Risk Results of an acute oral toxicity study with northern bobwhite quail indicate that pine oil is practically non toxic to avian species on an acute oral basis. In an subacute avian dietary study, pine oil was also found to be practically non toxic to avian species. The acute toxicity of pine oils to mammals is defined by rat toxicity values obtained from studies conducted to support data requirements for human health risk assessment. Toxicity data for pine oils are presented in Tables 10 12. Acute toxicity testing with estuarine and marine organisms is not required for pine oil.

Pine oil is slightly toxic to freshwater fish and invertebrates on an acute basis. Chronic toxicity testing for freshwater organisms is not required for pine oils and no information is currently available. Likewise, plant toxicity information on pine oil is not available; however, terrestrial and aquatic plant testing is not required to support the indoor uses of pine oil.

Table 11. Acute Oral Toxicity of Pine Oil Species Endpoint Toxicity Category Bird Page 33 of 34 Table 11. Acute Oral Toxicity of Pine Oil Species Endpoint Toxicity Category Bobwhite quail ( Colinus virginianus) LD50 > 2,250 mg/ kg NOEL = 486 mg/ kg Practically non toxic Mammal Rat LD50 = 2.7 g/ kg ( combined)

Table 12. Acute Ecotoxicity of Pine Oil Species Endpoints Toxicity Category Freshwater Fish Rainbow trout ( Oncorhynchus mykiss) LC50 = 18.4 ppm NOEC = 10 ppm Slightly toxic Bluegill ( Lepomis macrochirus) LC50 = 54.8 ppm NOEC = 36 ppm Slightly toxic Freshwater Invertebrate Water flea ( Daphnia magna) EC50 = 24.5 ppm NOEC = 11 ppm Slightly toxic Table 13. Other Toxicity Studies of Pine Oil Species Endpoint Toxicity Category Subacute Dietary Toxicity Mallard ( Anas platyrhynchos) LC50 > 5,620 ppm Practically non toxic Acute Dermal Toxicity Rat > 2,000 mg/ kg

Developmental Toxicity Rat NOAEL= 50 mg/ kg/ day ( maternal and developmental)

LOAEL = 600 mg/ kg/ day ( maternal and developmental)   The indoor uses of Pine Oil considered in this RED make it unlikely that any appreciable exposure to terrestrial or aquatic organisms would occur when it is used according to label directions. The low toxicity to birds, mammals, and aquatic organisms makes it even more unlikely that the indoor uses of this chemical pose a risk to these species. Risk to plants cannot be Page 34 of 34 addressed due to a lack of phytotoxicity data; however, exposure to plants is unlikely from the indoor uses of this chemical.

Endangered Species Consideration The Agency has developed the Endangered Species Protection Program to identify pesticides whose use may cause adverse impacts on endangered and threatened species, and to implement mitigation measures that address these impacts. The Endangered Species Act requires federal agencies to ensure that their actions are not likely to jeopardize listed species or adversely modify designated critical habitat. To analyze the potential of registered pesticide uses to affect any particular species, EPA puts basic toxicity and exposure data developed for risk assessments into context for individual listed species and their locations by evaluating important ecological parameters, pesticide use information, the geographic relationship between specific pesticide uses and species locations, and biological requirements and behavioral aspects of the particular species. A determination that there is a likelihood of potential impact to a listed species may result in limitations on use of the pesticide, other measures to mitigate any potential impact, or consultations with the Fish and Wildlife Service and/ or the National Marine Fisheries Service as necessary.

Based on the low likelihood of environmental exposure from the registered indoor uses, coupled with the low toxicity of pine oil to fish, aquatic invertebrates, mammals, and birds, adverse impacts to endangered birds, fish and aquatic invertebrate species are not expected from the registered uses of pine oil. Risk to endangered plants cannot be addressed due to a lack of phytotoxicity data; however, exposure to endangered plants is unlikely from the indoor uses of this chemical.

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

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.


[Federal Register Volume 78, Number 223 (Tuesday, November 19, 2013)]
[Notices]
[Pages 69404-69405]
[FR Doc No: 2013-27605]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CD14-8-000]

 Massachusetts Water Resources Authority; Notice of Preliminary
Determination of a Qualifying Conduit Hydropower Facility and
Soliciting Comments and Motions To Intervene

    On November 5, 2013, the Massachusetts Water Resources Authority
filed a notice of intent to construct a qualifying conduit hydropower
facility, pursuant to section 30 of the Federal Power Act, as amended
by section 4 of the Hydropower Regulatory Efficiency Act of 2013
(HREA). The Chicopee Valley Aqueduct--Fish Hatchery Pipeline Project
would be located along the proposed McLaughlin Fish Hatchery Pipeline
at the Massachusetts Water Resources Authority's Ware Disinfection
Facility in Hampshire County, Massachusetts.
    Applicant Contact: Pamela Heidell, Massachusetts Water Resources
Authority, 100 First Avenue, Charlestown Navy Yard, Boston, MA 02129,
Phone No.<PHONE_NUMBER>.
    FERC Contact: Christopher Chaney, Phone No.<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>    Qualifying Conduit Hydropower Facility Description: The proposed
project would consist of: (1) An approximately 21-feet-wide by 38-feet-
long underground powerhouse vault, containing one 59-kilowatt turbine/
generating unit in line with the proposed 20-inch-diameter McLaughlin
Fish Hatchery Pipeline; and (2) appurtenant facilities. The proposed
project would have an estimated annual generating capacity of 447
megawatt-hours.
    A qualifying conduit hydropower facility is one that is determined
or

deemed to meet all of the criteria shown in the table below.

                          Table 1--Criteria for Qualifying Conduit Hydropower Facility
----------------------------------------------------------------------------------------------------------------
                                                                                Satisfies (Y/
              Statutory provision                                   Description                          N)
----------------------------------------------------------------------------------------------------------------
FPA 30(a)(3)(A), as amended by HREA............  The conduit the facility uses is a tunnel, canal,            Y
                                                  pipeline, aqueduct, flume, ditch, or similar
                                                  manmade water conveyance that is operated for
                                                  the distribution of water for agricultural,
                                                  municipal, or industrial consumption and not
                                                  primarily for the generation of electricity.
FPA 30(a)(3)(C)(i), as amended by HREA.........  The facility is constructed, operated, or                    Y
                                                  maintained for the generation of electric power
                                                  and uses for such generation only the
                                                  hydroelectric potential of a non-federally owned
                                                  conduit.
FPA 30(a)(3)(C)(ii), as amended by HREA........  The facility has an installed capacity that does             Y
                                                  not exceed 5 megawatts.
FPA 30(a)(3)(C)(iii), as amended by HREA.......  On or before August 9, 2013, the facility is not             Y
                                                  licensed, or exempted from the licensing
                                                  requirements of Part I of the FPA.
----------------------------------------------------------------------------------------------------------------

    Preliminary Determination: Based upon the above criteria,
Commission staff preliminarily determines that the proposal satisfies
the requirements for a qualifying conduit hydropower facility not
required to be licensed or exempted from licensing.
    Comments and Motions To Intervene: Deadline for filing comments
contesting whether the facility meets the qualifying criteria is 45
days from the issuance date of this notice.
    Deadline for filing motions to intervene is 30 days from the
issuance date of this notice.
    Anyone may submit comments or a motion to intervene in accordance
with the requirements of Rules of Practice and Procedure, 18 CFR
385.210 and 385.214. Any motions to intervene must be received on or
before the specified deadline date for the particular proceeding.
    Filing and Service of Responsive Documents: All filings must (1)
bear in all capital letters the ``COMMENTS CONTESTING QUALIFICATION FOR
A CONDUIT HYDROPOWER FACILITY'' or ``MOTION TO INTERVENE,'' as
applicable; (2) state in the heading the name of the applicant and the
project number of the application to which the filing responds; (3)
state the name, address, and telephone number of the person filing; and
(4) otherwise comply with the requirements of sections 385.2001 through
385.2005 of the Commission's regulations.\1\ All comments contesting
Commission staff's preliminary determination that the facility meets
the qualifying criteria must set forth their evidentiary basis.
---------------------------------------------------------------------------

    \1\ 18 CFR 385.2001-2005 (2013).
---------------------------------------------------------------------------

    The Commission strongly encourages electronic filing. Please file
motions to intervene and comments using the Commission's eFiling system
at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit
brief comments up to 6,000 characters, without prior registration,
using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the
end of your comments. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>(866) 208-3676 (toll free), or
(202) 502-8659 (TTY). In lieu of electronic filing, please send a paper
copy to: Secretary, Federal Energy Regulatory Commission, 888 First
Street NE., Washington, DC 20426. A copy of all other filings in
reference to this application must be accompanied by proof of service
on all persons listed in the service list prepared by the Commission in
this proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.
    Locations of Notice of Intent: Copies of the notice of intent can
be obtained directly from the applicant or such copies can be viewed
and reproduced at the Commission in its Public Reference Room, Room 2A,
888 First Street NE., Washington, DC 20426. The filing may also be
viewed on the Web at http://www.ferc.gov/docs-filing/elibrary.asp using
the ``eLibrary'' link. Enter the docket number (e.g., CD14-8) in the
docket number field to access the document. For assistance, call toll-
free 1-866-208-3676 or email<EMAIL_ADDRESS>For TTY, call
(202) 502-8659.

    Dated: November 12, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-27605 Filed 11-18-13; 8:45 am]
BILLING CODE 6717-01-P