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**COMPANY FEDERAL REGISTER DOCUMENT SUBMISSION TEMPLATE (7/1/2006)**  **EPA Registration Division contact: [**  **Kable Bo Da vis**  **at 703 -** **30 6**  **- 0415**  **]**

**INSTRUCTIONS: Please utilize this outline in preparing tolerance petition**  **documents. In cases where the outline element does not apply please insert “NA****** **Remove” and maintain the outline. The comment n otes that appear on the left**  **ma rgin represent hidden typesetting codes designed to expedite the processing of the**  **Federal Register document. Please do not remove or alter these comment notes or change the margins, font, or format in your document. Simply**  **replace the instructions that appear in italics and brackets, i.e., “[** **insert company name ],” with**  **the information specific to your action. ]**  **TEMPLATE: [** **BASF Corporation ]**  **[Insert petition number, PP -** **xxxxxx]** 21 U.S.C. 346 EPA has received a pesticide petition **( [Insert petition number,**  **PP -** **xxxxxx ]**  **)** from **[ BASF Corporation**  **] ,**  **[ 26 Davis Drive,**  **Research Triangle Park, NC**  **, 27709**  **]** proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180. 361 by establishing a tolerance for the residues of **[the herbicide pendimethalin, including its**  **metabolites and degradates, in or on animal commodities. Compliance with the tolerance levels specified is to be determined by measuring only pendimethalin**  **, N -**  **(1 -**  **ethylpropyl) -** **3,4 -**  **dimethyl -** **2,6dinitrobenzenamine, and its animal metabolite**  **1 -**  **(1 -**  **ethyl -** **propyl) -**  **5, 6 dimethyl -**  **7 -**  **nitro -**  **1H -** **benzoimidazole ,**  **calculated as the stoichiometric equivalent of pendimethalin**  **]** in or on the raw agricultural animal commodities **[ milk]**  at **[ 0.04**  **]** parts per million (ppm), **[ cattle, goat, horse, and sheep,**  **fat ]**  at **[ 0.30**  **]** parts per million (ppm) , **[ cattle, goat, horse, and sheep, liver]**  at **[ 1.5**  **]** parts per million (ppm), **[ cattle, goat, horse, and sheep, meat]**  at **[ 0.10**  **]** parts per million (ppm), and **[ cattle, goat, horse, and sheep, meat byproduct** **s except liver]**  at **[ 3.0**  **]** parts per million (ppm), and by amending the established tolerances for the combined residues of **[the herbicide pendimethalin, including its metabolites and degradates, in or on**  **fe ed**  **commodities. Compliance with the tolerance levels specified is to be determined by measuring only pendimethalin**  **, N -**  **(1 -**  **ethylpropyl) -** **3,4 -**  **dimethyl****** **2,6dinitrobenzenamine, and its metabolite ,**  **4 -**  **[(1 -**  **ethylpropyl)amino] -** **2 -**  **methyl -** **3,5 -**  **dinitrobenzyl alcohol, calcu lated as the stoichiometric equivalent of pendimethalin**  **]** in or on the raw agricultural commodities of **[ Grass forage, fodder, and hay crop group**  **17, forage ]**  at **[ 1000**  **]** parts per million (ppm) , and **[ Grass forage, fodder, and hay crop** 2

**group 17, hay ]**  at **[ 2000**  **]** parts per million (ppm) . EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of the FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition. A. Residue Chemistry 1. Plant metabolism. **[ The qualitative nature of the residues of pendimethalin**  **in plants is understood based on adequate studies conducted with 14C**  **pendimethalin on various crops. Pendimethalin and its 3,5**  **- dinitrobenzyl alcohol**  **metabolite (CL202347) are the established**  **residues of concern .]**  2. Analytical method. **[ Section 408 (b)(3) of the amended FDCA requires EPA**  **to det ermine that there is a practical method for detecting and measuring levels of**  **the pesticide chemical residue in or on food and that the tolerance be set at a level at or above of the limit of detection of the designated method.**  **In plants ,**  **the method is aq**  **ueous organic solvent extraction, column clean up, and quantitation by GC. The method has a limit of quantitation (LOQ) of 0.05 ppm for pendimethalin and the**  **alcohol metabolite. I**  **n the**  **animal commodit** **y method**  **D0405 ,**  **pendimethalin and its**  **metabolites (CL 2 02347 and Goat Metabolite 6) are extracted from milk and tissue**  **with acidic aqueous methanol. An aliquot is taken from extract, diluted with water and then cleaned using a solid phase extraction column. The compounds are eluted**  **from the column using methan**  **ol/water. The eluates are diluted with methanol/water for analysis via LC/MS/MS. The results are calculated separately by direct**  **comparison of the sample peak responses to those of external standards .**  **The method has a limit of quantitation (LOQ) of 0.01**  **in milk**  **and 0.05 ppm in tissues**  **for both**  **pendimethalin and the goat metabolite 6 .**  **The method has undergone an**  **independent laboratory validation .**  **]** 3. Magnitude of residues. **[ Fi**  **eld trials in major growing areas were conducted**  **in order to determine the magni tude of residues in**  **forage grass (MRID 47471701)**  **comm odities.**  **Field trials were carried out using the maximum number of applications, the maximum label rate and shortest pre** **- harvest interval (PHI)**  **in forage grass at 0 day** **. Decline data indicated the averag**  **e half -** **li ves on the order of 10**  **days in grass forage**  **and hay**  **. Two dairy cattle feeding studies are available**  **to account for**  **secondary transfer of p**  **endimethalin residues occur from treated feedstuffs to bovine matrices**  **. A**  **recent dairy cattle feeding study**  **was conducted for**  **29 days with**  **a pend** **imethalin concentration of 760 mg/kg** **- feed**  **to cover the proposed use in grasses**  **. This study also included a 10**  **- day depuration phase to observe the**  **withdrawal of the compound from milk and tissues following the last dos ing**  **interval. Observed residue levels of pendimethalin and goat metabolite 6 in milk**  **and animal tissues support the proposed tolerances in animal matrices. A**  **previous feeding study (MRID 46591234)**  **was conducted**  **three levels of 10, 30 and 100 mg/kg** **** **feed; at th**  **ese lower exposure level** **s , no residues in**  **milk or any tissue were noted above the LOQ for pendimethalin, or two metabolite analytes at the highest dose**  **level tested of 100 ppm. EPA has determined that the petition contains data or** 3

**information regardi ng the above aforementioned crops and animal feeding study** 

. **]** B. Toxicological Profile 1. Acute toxicity. **[ Pendimethalin technical demonstrates low acute toxicity via**  **the oral, dermal ,**  **and inhalation routes of exposure. The acute toxicity studies plac e**  **technical pendimethalin in toxicity category III for the acute oral, category IV for acute dermal, and category IV for acute inhalation.**  **The acute reference dose is based on reduced motor activity at Day 0 in the acute neurotoxicity study.**  **Technical pen**  **dimethalin is category IV for skin irritation and category III for eye irritation. Pendimethalin did not cause skin sensitization in guinea pigs. Two formulated end**  **use products are registered for use on crops, an Emulsifiable Concentrate (EC) and an Enca** **psulated Suspension (CS). The EC has an acute oral category of III, acute dermal category of III, an acute inhalation category of III, eye and skin irritation of**  **III, and is not a dermal sensitizer. The CS has an acute oral category of IV, an acute derma** **l category of IV, an acute inhalation category of IV, eye and skin irritation category of IV, and is not a dermal sensitizer.**  **]** 2. Genotoxicty. **[ Extensive**  **mutagenicity studies**  **conducted to**  **investigate point**  **and gene**  **mutations, DNA**  **damage and**  **chromosomal a** **berration, both**  **using in**  **vitro and in vivo test systems demonstrate pendimethalin to be non**  **- genotoxic.**  **Pendimethalin has been classified as a Group C "possible human carcinogen," based on a statistically significantly increased incidence of benign follic** **ular cell adenomas of the thyroid gland in male and female rats at 5000 ppm (250 mg/kg**  **b.w./day) (highest concentration tested). For risk assessment, OPP recommends using the RfD (non**  **- linear) approach for quantification of human risk. The Agency**  **Committe e has determined that the hypothesis, that benign thyroid tumors**  **associated with pendimethalin are due to a thyroid -** **pituitary imbalance, can be supported. Finally, pendimethalin's mechanism of threshold oncogenic activity only**  **occurs at high doses in rats , a mammalian species that is expected to be much more**  **sensitive than humans to the induction of thyroid tumors via conditions which result in hypothyroidism**  **.]** 3. Reproductive and developmental toxicity. **[ Pendimethalin is not a selective**  **developmental to xicant. There is no indication of increased susceptibility following**  **prenatal/postnatal exposure to pendimethalin. In a developmental (teratology) toxicity study in the rat, the results demonstrated**  **that the NOAELs for both maternal toxicity and fetal (prenatal)/developmental**  **toxicity were 500 mg/kg b.w./day (highest dose tested) (HDT). In addition, there were no indications of any teratogenic effects in the rat fetuses at 500 mg/kg**  **b.w./day (HDT). Therefore, pendimethalin is considered to be neither a**  **developmental toxicant nor a teratogenic agent in the rat. In a developmental (teratology) toxicity study in the rabbit, the results**  **demonstrated the NOAEL for maternal toxicity was 30 mg/kg b.w./day, based on**4

**increased clinical signs of toxicity and decreased body weight gain during the**  **treatment period at 60 mg/kg b.w./day (HDT). The NOAEL for fetal (prenatal)/developmental toxicity was 60 mg/kg b.w./day (HDT). In addition, there**  **were no indications of any teratogenic effects in the rabbit fetuses at 60 mg/kg**  **b.w./day. Therefore, pendimethalin is considered to be neither a developmental toxicant nor a teratogenic agent in the rabbit.**  **A two -**  **generation reproductive toxicity study in the rat demonstrated an absence of increased sensitivity for the de** **veloping offspring to pendimethalin. The NOAEL for parental toxicity was 500 ppm (approximately 38.5 mg/kg b.w./day), based on**  **reduced food consumption and decreased body weight/weight gain at 2500 ppm (mid** **- dietary concentration). The NOAEL for pup/offsp**  **ring toxicity was also 500 ppm, based on decreased pup body weight gain at 2500 ppm. Lastly, the NOAEL**  **for reproductive toxicity was 2500 ppm (approximately 194 mg/kg b.w./day), based on reduced mean live litter size at 5000 ppm (highest concentration tes** **ted) (HCT). These reductions in mean live litter size and pup body weight gain were only**  **observed at dietary concentrations that were parentally toxic. As such, there is no evidence that prenatal or postnatal exposure to pendimethalin results in an**  **incre ased sensitivity to developing offspring.**  **]** 4. Sub

- chronic toxicity. **[ Sub**  **- chronic (90**  **- day) feeding studies were conducted**  **in rats and dogs. For the rat, the NOAEL for systemic toxicity was 500 ppm (41 mg/kg b.w./day), based on slightly decreased body wei**  **ght, increased absolute and relative liver weights, and liver histopathology (hepatocellular hypertrophy) in**  **males and females at 5000 ppm (HCT). For the dog, the NOAEL for systemic toxicity was 2500 ppm (62.5 mg/kg b.w./day), based on decreased body weig**  **ht at 10000 ppm (250 mg/kg b.w./day)**  **.]** 5. Chronic toxicity. **[ The chronic Reference Dose (RfD) was established based**  **on the results of sub -**  **chronic special studies demonstrating the thyroid hormone related endpoint in rats. The NOAEL of 10 mg/kg b.w./day**  **was established from the collective results of the sub**  **- chronic oral 92**  **- day thyroid function study, the sub**  **** **chronic oral 56 -**  **day thyroid function study, and the 14 -**  **day intrathyroidal metabolism study. A LOAEL of 31 mg/kg b.w./day was based on hormonal and**  **h istopathological changes in the thyroid gland. The chronic RfD was calculated to**  **be 0.3 mg/kg b.w./day using an Uncertainty Factor (UF) of 30X (3X for interspecies extrapolation and 10X for intraspecies variability)**  **. EPA/HED currently**  **recommends a FQPA S afety Factor of 1X. Therefore, the chronic Population**  **Adjusted Dose (PAD) is 0.3 mg/kg b.w./day. Chronic toxicity studies were conducted in rats, mice, and dogs. For the 2**  **- year rat**  **feeding study, the NOAEL for systemic toxicity was 500 ppm (25 mg/kg b.w ./day),**  **based on decreased body weight gain (approximately 20 -** **30%), increased clinical signs of toxicity, increased relative liver weights, and slight but statistical increase in**  **the incidence of benign follicular cell adenomas of the thyroid gland in male s and**  **females at 5000 ppm (250 mg/kg b.w./day) (HCT). For the 18 -**  **month mouse feeding study, the NOAEL for systemic toxicity was 500 ppm (75 mg/kg b.w./day), based on** 5

**slightly decreased mean body weights and reduced survival at 5000 ppm (750 mg/kg b.w./day** **) (HCT). There were no oncogenic effects up to 5000 ppm (750 mg/kg b.w./day) (HCT). Lastly, for the 1**  **- year oral (via gelatin capsules) chronic dog study,**  **the NOAEL for systemic toxicity was 200 mg/kg b.w./day, the highest dose tested .]**  6. Animal metabo lism. **[ Adequate goat and poultry metabolism studies are**  **available for pendimethalin. In the rat, pendimethalin is metabolized mainly through oxidation of the 4**  **- methyl group attached to the benzene ring as well as**  **oxidation of the alkyl side chain of the N -**  **substituted dinitroaniline compound. When C14**  **- pendimethalin is administered to rats, about 70% of the**  **administered radioactivity is excreted**  **via feces and 20%**  **via urine within 24 hours. Within 96**  **hours, the total radioactive residues (TRR)**  **found in the t issues was 0.3 ppm, except**  **fat which was**  **0.9 ppm. The major portion of the radioactivity that was excreted in the feces was identified as the**  **unchanged parent compound. In the goat metabolism**  **study following administration of radiolabeled pendimethalin e quivalent to 15.35**  **ppm in the diet for 5 consecutive days, approximately 94% of the administered radioactivity was recovered in feces, urine and tissues. Among the edible tissues,**  **only liver (0.32 ppm) and kidney (0.042 ppm) contained residues >0.01 ppm. With**  **the exception of Metabolite 6 (13% TRR), no other component exceeded 10% of the TRR in liver. The major metabolite (Metabolite 6) was identified in feces, bile and**  **urine by LC/MS and high resolution mass spectrometry. Only trace levels of unchanged**  **parent were**  **detected. ]**  7. Metabolite toxicology

. **[ The main pendimethalin plant metabolite, CL**  **202347, has been tested for acute oral toxicity in the mouse,**  **as well as genotoxicity (Ames assay). The acute oral**  **LD50 in**  **the mouse was determined to be 2140**  **mg/kg bw,**  **which is considered to be “slightly toxic**  **by ingestion in single doses.” An Ames**  **assay demonstrated that the plant metabolite is non -**  **mutagenic. In addition, since**  **goat Metabolite 6 was observed in a recent rat metabolism study, it is considere d to**  **have been evaluated in the existing mammalian toxicity database for the active ingredient.**  **]** 8. Endocrine disruption

. **[ It is known that pendimethalin affects the**  **hypothalamus -** **pituitary -** **thyroid axis. However, as the chronic RfD (0.3 mg/kg b.w./day) i**  **s based on the thyroid hormone related endpoint in rats, as noted in the sub**  **- chronic special studies in Section 5 above, which additionally demonstrated**  **reversibility of the thyroid effects in the oral 56 -**  **day thyroid function study, these effects are alrea**  **dy taken into consideration in the characterization of potential risks to humans.**  **]** C. Aggregate Exposure **[ Pendimethalin is a pre** **- emergent herbicide used to control**  **broadleaf and grass weeds in food and non -** **food crops, as well as non -**  **agricultural use sites**  **including residential lawns. In examining aggregate exposure, FQPA directs EPA to consider available information concerning exposures from the**  **pesticide residue in food and water (dietary) and all other non -**  **occupational exposures. The primary non**  **- food sou**  **rces of exposure are through pesticide use in gardens, lawns, or buildings (residential and other indoor uses). The potential for** 6

**aggregate exposure from all registered and proposed uses is discussed below .]**  1. Dietary exposure. **[The updated dietary asse**  **ssments employed the EPA posted**  **Dietary Exposure Evaluation Model -**  **Fo od Consumption Intake Database**  **( DEEM** **- FCID)**  **version 3.18 and the residue input files from their July 2012 dietary**  **assessment DP 401100**  **for any concentration factors as a starting point.**  **]** i. Food. **[ An**  **assessment was**  **conducted to**  **evaluate the**  **potential risk**  **due to**  **dietary exposure**  **of the**  **U.S. population**  **to residues**  **of pendimethalin.**  **T he**  **current tolerance**  **values are**  **listed in**  **the U.S.**  **40 CFR**  **§ 180.**  **361. The**  **Tier 1**  **dietary exposure**  **estimates were**  **based on**  **established and**  **proposed tolerance**  **values, and**  **100% CT**  **values. An**  **updated analysis**  **included all**  **the crops**  **with esta** **blished tolerance**  **values as**  **of March**  **201 4**  **and: the**  **proposed t** **olerances for**  **hops, dried**  **cones at**  **1 .0 ppm**  **(pending EPA review, submitted October 2013)**  **; the**  **proposed crop group**  **expansion tolerances**  **to replace**  **current existing**  **pendimethalin tolerances**  **including onion**  **- bulb**  **subgroup 3**  **- 07A**  **= 0.10**  **ppm, onion**  **- green**  **subgroup 3**  **- 07B**  **= 0.20 ppm, low growing berry subgroup 13**  **- 07G = 0.10 ppm,**  **vegetable -**  **fr uiting group**  **8 -**  **10 = 0.10 ppm, fruit -**  **citrus group 10 -**  **10, fruit -** **pome group 1**  **1 -**  **10 = 0.10 ppm, fruit****** **stone group 12**  **- 12 = 0.10 ppm** **, sunflower subgroup = 0.1 ppm (pending**  **EPA review,**  **submitted October**  **2013) ;**  **the proposed**  **amended tolerances**  **for alfalf**  **a forage**  **a n**  **d hay**  **(pending EPA**  **review, submitted**  **February 2014);**  **and the**  **proposed new**  **tolerances on**  **animal commodities**  **which support**  **the newly**  **proposed am** **ended tolerances**  **on forage grasses**  **. Acute Dietary**  **(food + drinking water) Exposure Assessment**  **No speci**  **al dietary**  **assessment for**  **females age**  **13**

**– 49**  **years old**  **is required**  **by EPA**  **because no**  **endpoint was**  **identified for**  **sensitive populations**  **. EPA**  **has determined**  **that an acute dietary assessment is required for the general populations which cover**  **infants and**  **ch ildren**  **. The**  **acute population**  **adjusted dos**  **e (aPAD)**  **is 1**  **mg ai/kg**  **bw/day based**  **on a**  **NOAEL =**  **100 mg/kg**  **bw/day and**  **a total**  **safety factor**  **of 100.**  **The acute**  **dietary exposure**  **to pendimethalin**  **residues was**  **low for**  **all populations.**  **At the**  **95 th**  **percentile, t** **he mos**  **t highly**  **expos ed**  **valid sub**  **- population**  **was “I** **nfants (<1 year old)**  **” and**  **this group utilized**  **only 1.8**  **% aPAD.**  **Chronic Dietary (food + water)**  **Exposure Assessment Dietary**  **exposure estimates**  **were compared**  **against the**  **chronic Population**  **Adjusted Dose**  **(cPAD) of**  **0. 3**  **mg/kg b.w./day**  **for all**  **populations subgroups.**  **Results of**  **the chronic**  **dietary assessments**  **are listed**  **in T**  **able 1**  **below. The**  **estimated chronic**  **dietary exposure**  **from crops**  **and animals**  **(both established**  **and proposed**  **tolerances) was**  **< 2.**  **2 %**  **of the**  **cPAD for**  **all s**  **ubpopulations. Additional**  **refinements such**  **as the**  **use of**  **anticipated residues**  **, PDP**  **data and**  **percent crop**  **treated values**  **for the**  **established crop**  **uses would**  **further reduce**  **the estimated**  **chronic dietary**  **exposure. The**  **results in**  **Table 1**  **below demonstrate**  **the re**  **are no**  **risk concerns**  **for any**  **subpopulation based**  **on established**  **and new**  **uses, and**  **that the**  **results clearly**  **meet the FQPA standard of reasonable certainty of no harm.**7 **Table 1. Summary of Chronic D**  **ietary Ex** **posure (food + drinking water)**  **A ssessment consi**  **dering crops with established and proposed tolerances**  **for pendimethalin. Population**  **Subgroups Exposure Estimate**  **(mg/kg b.w./day) %cPAD**  **US Population 0.0019**  **28 0.6**  **Al l infants (< 1 year)**  **0.0036 16**  **1. 2**  **Children 1 -** **2 0.006**  **486 2.**  **2 Children 3**  **- 5**  **0.004922 1.6**  **Children 6 -**  **12 0.002923**  **1.0 Youth 13**  **- 19**  **0.001635 0.5**  **Ad ults 20**  **- 49**  **0.001500 0.5**  **Ad ults 50+ yrs**  **0.001395 0.5**  **Females 13 -**  **49 yrs 0.001463**  **0.5 %cPAD = percent of chronic population adjusted dose**  **Exposure estim ates based on tolerance values and 100 % CT v**  **alues ]**  ii. Drinking Wa ter. **[ The**  **drinking water**  **exposure values**  **used in**  **this assessment**  **were obtained**  **from the**  **most recent**  **pendimethalin assessment**  **conducted by**  **EPA published**  **on July**  **25, 2012**  **. The**  **estimated acute**  **and chronic**  **surface water**  **concentrations from**  **EP A**  **models were**  **80.5 μg/L**  **and 6.**  **2 μ**  **g/L, respectively.**  **The estimated**  **g roundwater**  **concentration was**  **0.0 36**  **μ g/L.**  **The se**  **estimated drinking**  **water exposure**  **s were**  **inclu ded**  **directly in**  **the dietary**  **assessment s**  **. The DEEM critical exposure**  **contribution analysi s calculates**  **estimated model**  **water contributions**  **(indirect and**  **direct) makeup**  **over 60%**  **of the**  **potential exposure**  **of pendimethalin**  **for infants**  **within the**  **acute assessment**  **; the**  **modelled water estimates are understood to be conservative.**  **]** 2. Non

-dietary exp osure . **[ The**  **post -**  **application short** **- term**  **dermal and**  **incidental oral**  **exposure and**  **risk assessment**  **was determined**  **for pendimethalin**  **use on**  **residential turf,**  **residential gardens,**  **and golf**  **course turf.**  **The residential**  **exposure shown**  **in the**  **Table 2**  **reflects the**  **most recent**  **EP A**  **human health**  **risk assessment**  **published on**  **July 25,**  **2012. No**  **new uses**  **would impact**  **reuse of**  **this assessment.**  **The residential**  **assessment was**  **conducted using**  **the updated**  **Standard Operating**  **Procedures for**  **Residential Pesticide**  **Exposure Assess**  **ment. T**  **he calculated**  **MOEs are**  **all greater**  **than the**  **MOE level**  **of concern**  **, which**  **is a**  **value of**  **30 .**  **Table 2**  **. Pendimethalin**  **R esidential**  **Exposure after**  **the use**  **o n**  **Residential Turf,** 

**Residential Gardens, and Golf Course Turf. Population**  **Scenario -**  **Route Expos**  **ure MOE**  **Adult Turf** **** **residential Dermal**  **0.032 3**  **20 Child 1**  **- 2**  **Turf -**  **Dermal 0.06**  **1 70** 8 **residential Hand to mouth**  **0.042 2**  **40**

**Object to mouth 0.0013**  **7 ,700**  **soil ingestion 0.000065**  **15 0,000**  **Granular injestion**  **0.071 140**  **Adult Turf**  **- golf**  **Dermal 0.**  **0037 2,700**  **Children 11 -**  **16 Turf**  **- Golf**  **Dermal 0.0043**  **2 ,** **3 00**  **Children 6 -**  **11 Turf**  **- Golf**  **Dermal 0.0051**  **2,000 Adult**  **Gardening Dermal**  **0.078 1**  **30 Children 6**  **- 11**  **Gardening Dermal**  **0.053 1**  **90 Acute Aggregate Exposure and Risk (Food and water)**  **It has**  **been previously**  **d etermined**  **by EP** **A that**  **the acute**  **aggregate assessments**  **includes only**  **food and**  **drinking water**  **exposure (DP390457).**  **R esidential**  **exposure is**  **not included**  **in the**  **acute or**  **chronic aggregate**  **assessment. T**  **he results**  **showed that**  **the acute**  **aggregate exposure**  **from pendimethalin**  **residues does**  **not exceed**  **the level of concern for any population.**  **Short -**  **and Intermediate** **- Term**  **Aggregate Exposure**  **and Risk**  **(food, water,**  **and residential)**  **Short -** **term aggregate**  **risk from**  **pendimethalin takes**  **into account**  **exposures from**  **dietar y**  **consumption (food**  **and water)**  **and residential**  **exposure from**  **turf use.**  **P ost**  **application exposure**  **fr om**  **the turf**  **use is**  **considered short** **- term.**  **T he**  **residential exposure**  **used in**  **this assessment**  **is from**  **the most**  **recent EP** **A human**  **health risk**  **assessment publish**  **ed July 25, 2012, no new residential uses impact the aggregate, so only an update to the dietary components is needed. The residential assessment was**  **conducted using**  **the updated**  **Standard Operating**  **Procedures for**  **Residential Pesticide**  **Exposure Assessment.**  **The post** **- application**  **residential exposure**  **was determined**  **for the**  **use on**  **residential turf,**  **residential gardens,**  **and golf**  **course turf.**  **The highest**  **post -**  **application exposure**  **from adults**  **was from**  **the garden**  **use and**  **residential turf**  **use for**  **children 1**  **- 2**  **years old.**  **T he**  **children exposure**  **included dermal**  **and hand** **- to**  **- mouth**  **exposure. T**  **he aggregate**  **MOE from**  **food, water,**  **and residential**  **exposure for**  **children 1**  **- 2**  **years old**  **was 92**  **and for**  **adults 125.**  **T hese**  **MOEs are**  **greater than**  **the target**  **MOE of**  **30, which**  **indicates there**  **is no**  **risk concern**  **from the**  **aggregate exposure**  **from pendimethalin.**  **T he**  **results of**  **the analysis are shown in Tables**  **3 .**  **Table 3**  **. Estimated short/intermediate term aggregate exposure and risk of** 

**pendimethalin .**  **Population NOAEL** 

**(mg/kg/day) Target** 

**MO E**  **1 Food**  **+ Drinking Water**

**Exposure (mg/kg/day)**  **Residential**

**Exposure (mg/kg/day)**  **Total**

**Exposure (mg/kg/day)**  **MOE 2** 

**Adult 10**  **30 0.0019**  **28 0.078**  **0.0799 28**  **125**9

**Child 1**  **- 2 yr old**  **10 30**  **0.006 486**  **0.102 0.108**  **486 92** 
**1 HED’s LOC for the**  **MOE is 30. 2**  **Ag gregate MOE = (NOAEL / (Food + Water + Residential Exposure)**  **Chronic Aggregate Exposure and Risk (food and water) It has been previously determined by EPA that the chronic aggregate assessments**  **includes only food and drinking water exposure (Table 1), b ecause exposure is not**  **expected for residential (dermal and inhalation) exposure pathway (DP390457). Exposures from residential uses are not included in the chronic aggregate**  **assessment. The re sults demonstrate there are no risk**  **concerns for any subpopula** **tion ba sed on established and new uses.**  **]** D. Cumulative Effects **[ Exposure to Substances with Common Mechanism of Toxicity. The Agency**  **has not yet published guidelines to determine whether pendimethalin has a common mechanism of toxicity with other subs**  **tances or how to include this pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA has followed a**  **cumulative risk approach based on a common mechanism of toxicity, pendimethalin does not appear to produce a toxic metabolite pro**  **duced by other substances. For the purposes of this tolerance action, therefore, it is assumed that pendimethalin**  **does not have a common mechanism of toxicity with other substances. ]**  E. Safety Determination 1. U.S. population. **[ Based on these risk asse**  **ssments, there is a reasonable certainty that**  **the aggregate exposure to the general population or any**  **subpopulation from pendimethalin residues does not result in an unacceptable risk.**  **]** 2. Infants and children

. **[ EPA has previously recommende**  **d the 10X FQP** **A safety factor be remove**  **d (reduced to 1X) based on reliable data.**  **Based on these risk assessments, there is a reasonable certainty that**  **the aggregate exposure to infants or**  **children, or any subpopulation from pendimethalin residues**  **does not result in an unacceptable risk** **.]** F. International Tolerances **[ There are no CODEX, Canadian or Mexican International Maximum**  **Residue Levels (MRL's) established for residues of pendimethalin in these crops at this time**  **.]**