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**EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER**  **EPA Registration**  **Division contact: [**  **Kathryn Montague, 703 -** **305 -**  **1243 ]**  **INSTRUCTIONS: Please utilize this outline in preparing the pesticide petition. In**  **cases where the outline element does not apply, please insert “NA -** **Remove” and maintain the outline. Please do not change the margins, font, or format in your**  **pesticide petition. Simply re place the instructions that appear in**  **green , i.e., “**  **[ insert**  **company name ]**  **,” with the information specific to your action. TEMPLATE:**  **[ Monsanto Company**  **] [Insert petition number]**  EPA has received a pesticide petition **( [insert**  **petition number] )**  from **[ Monsanto Company**  **, EPA Company Number 524 ]**  **, [**  **1300 I St., NW., Suite 450 East, Washington DC 20052**  **]** 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 by establishing a tolerance for residues of **[ dicamba (3,6**  **- dichloro**  **- o**  **- anisic and its**  **metab o**  **lites 3,6 -**  **dichloro -**  **5 -**  **hydroxy -**  **o -**  **anisic acid (5**  **- OH dicamba)**  **and 3,6 -**  **dichloro**   ** 2** **- hydroxybenzoic acid**  **(DCSA) ]**  in or on the raw agricultural commodity **[ Cotton**  **, undelinted seed**  **]** at **[ 3**  **]** parts per million (ppm) and **[ Cotton**  **, gin by products**  **]** at **[ 70**  **]** 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 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 nature of dicamba residues in MON 88701**  **cotton is**  **adequately understood. The primary route of metabolism of dicamba in MON**  **88701 cotton**  **is by demethylation to form (** **3,6 -**  **dichloro -**  **salicylic acid (** **DCSA )**  **and subsequent glycosidation**  **to form conjugates . DCSA**  **and its conjugates are**  **ma jor**  **metabolite s**  **from both pre and postemergence applications of dicamba to MON**  **88701 cotton**  **, in addition to dicamba .**  **The current dicamba**  **residue definition as listed in 40 CFR part 180.227**  **(a)(1) for**  **undelinted cottonseed**  **includes dicamba and 5**  **- hydroxydicamba, expressed as dicamba equivalents**  **. Based on residue and**  **metabolism data, the proposed residue definition for dicamba in cotton** 2

**commodities , including dicamba**  **- tolerant cotton,**  **is: dicamba, DCSA and 5**  **- h**  **ydroxydicamba, expressed as dicamba equivalents.** 

2. Analytical method. **[ Adequate enforcement methods are available**  **for the analysis of residues of dicamba and its relevant metabolites in or on plant and**  **livestock commodities. Pesticide Analytical Manual (PAM) Vol. II lists appropriate**  **analytical methods, based on gas chromatography (GC) with electron capture**  **detection (GC/ECD), that are sufficient to provide for**  **the enforcement of proposed dicamba tolerances in**  **cotton seed**  **and cotton gin by -** **products .**  **]** 3. Magnitude of residues. **[ Residue data are available for residues of dicamba**  **in MON 88701**  **cotton .**  **The magnitude of dicamba, 5 -**  **hydroxydicamba, and**  **DCSA ,**  **combined in undelinted**  **cottonseed in dicamba acid equivalents**  **ranged from 0. 1**  **7 to**  **1. 7**  **2 ppm**  **, with a median of 0.54 ppm .**  **Cotton g in by** **- products samples**  **had residues of dicamba**  **ranging from**  **5.06 to 29 .**  **6 ppm**  **, with a median of 19.7 ppm.**

B. Toxicological Profile **[EPA has**  **previously evaluated available toxicology data on dicamba and concluded the data are sufficient**  **to merit reregistration. EPA also found the available data to be**  **adequate to characterize the toxicity of dicamba as it relates to human health including variability and sensitivity of major subgroups of consumers including**  **infants and children. The nature of dicamba toxicity is discussed in the 2006 Registration Eligi** **bility Decision (RED) and as part of a recent action to establish tolerances**  **76 FR 55804.** 1. Acute toxicity. **[ NA** **- remove**  **]** 2. Genotoxic i ty. **[ NA** **- remove**  **]** 3. Reproductive and developmental toxicity. **[ NA** **- remove**  **]** 4. Subchronic toxicity. **[ NA** **- remove**  **]** 5. Chronic toxicity. **[ NA** **- remove**  **]** 6. Animal metabolism. **[ NA** **- remove**  **]** 7. Metabolite toxicology

. **[ Toxicity**  **studies on**  **DCSA have**  **been conducted**  **to further**  **characterize its**  **toxicity. T**  **hese data**  **demonstrate that**  **the overall**  **toxicity profiles**  **of dicamba**  **and its**  **DCSA metabolite**  **are substantially**  **similar and**  **that DCSA**  **does not**  **present any**  **new or**  **unusual toxicity**  **concerns beyond**  **what has**  **already been**  **considered for**  **parent dicamba.**  **T herefore,**  **the established**  **dicamba t**  **oxicity endpoints**  **are sufficient**  **to assess**  **potential health**  **risks from**  **dietary exposure to DCSA metabolite.**  **}**3

8. Endocrine disruption

. **[ Dicamba does not belong to a class of chemicals**  **known for having adverse effects on the endocrine system. No effects indicative of**  **endocrine disruption have been observed in the various short -**  **and long -** **term studies conducted with various mammalian species**  **.]** C. Aggregate Exposure 1. Dietary exposure. **[Existing tolerances for dicamba residues in meat and milk are adequate to support the**  **proposed tolerance increase**  **s for**  **dicamba in cottonseed**  **and gin by -** **products . In addition, the proposed new use**  **on MON**  **88701 cotton**  **does not result in a n**  **increase in estim ated drinking water exposure beyond**  **t hat**  **already evaluated by EPA. Consequently, no**  **significant incremental dietary**  **(food plus water) exposure to dicamba residue**  **is anticipated from the proposed tolerances**  **. ]**  i. Food. **[ In support of the p**  **roposed tolerances for sweet corn commodities**  **(73 FR 17914)**  **, a highly conservative acute dietary assessment was conducted for all dicamba food exposures assuming 100% of crop and livestock food commodities**  **contain tolerance level residues. Drinking water values**  **were incorporated directly into the assessment.**  **Acute dietary (food plus water)**  **exposure (95 th**  **percentile) was conservatively estimated to be 0.044 mg/kg bw/day for the general population and**  **0.109 mg/kg bw/day for the most highly exposed sub population of**  **infants < 1year old. A Tier I chronic dietary assessment**  **was also conducted**  **, using 100% crop**  **treated and tolerance level residue**  **assumptions ,**  **and chronic dietary exposure was conservatively estimated to be 0.012 mg/kg bw/day for the general population and**  **0.030 mg/kg bw/day for the most highly exposed subpopulation of children**  **aged 1 -**  **2 years old**  **. The proposed changes in cotton commodity tolerances are not expected to**  **measurably increase these ex posure levels.**  **]** ii. Drinking water

. **[ In support of the p**  **roposed tolerances for sweet corn commodities (73**  **FR 17914), EPA estimated concentrations of dicamba and DCSA in**  **groundwater and surface water using the Pesticide Root Zone Model/Exposure**  **Analysis Modeling System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI**  **- GROW) models. Combined estimated environmental**  **concentrations (EECs) of dicamba and DCSA for acute exposures are estimated to be 367 parts per billion (ppb) for surface water and 0.016 ppb for ground water.**  **The combined EECs for chronic exposures are estimated to be 13.8 ppb for surface**  **water and 0.016 ppb for ground water .**  **Estimates of dietary**  **exposure from drinking water were**  **included in the food e**  **x posures reported above.**  **]** 2. Non

- dietary exposure

. **[ Dicamba is currently registered**  **for use on residential sites, including home lawns and golf courses. Residential handlers are**  **likely to be exposed to dicamba residues via dermal and inhalation routes during handling, mixing, loading and applying activities. Post application exposure to**  **dicamba also exists for adults and children who reenter a treated area. EPA**4

**assessed non -**  **dietary exposure (residential handler and residential post application) to dicamba in support of the proposed tolerances**  **for sweet corn commodities (**  **73 FR**  **17914 )**  **. Non**  **- dietary exposure to dicamba did**  **not exceed the Agency’s level of concern**  **. The proposed tolerances for cotton will not change the magnitude of non**  **** **dietary residential exposures. ]**  D. Cumulative Effects **[ EP** **A has not made a common mechanism of**  **toxicity finding for dicamba .]**  E. Safety Determination 1. U.S. population. **[ The proposed dicamba tolerances for**  **cotton undelinted seed and gin by** **- products**  **do not contribute**  **a significant**  **incremental dietary exposure to the general US population beyond that which has been previously**  **consider ed**  **by EPA as part of previous regulatory actions. A conservative dietary exposure analysis (food plus water) was conducted for dicamba in support of t**  **he proposed tolerances for sweet corn commodities (**  **73 FR 17914**  **). In that assessment,**  **d ietary exposure**  **as detailed above from all registered uses of dicamba combined**  **utilized only 4.4% aPAD and 2.6% cPAD for the general US population.**  **Considering the compl eteness of the overall toxicity database supporting this**  **petition, there is reasonable certainty that no harm will result from aggregate exposure arising from current and proposed dicamba uses including all anticipated**  **dietary and non -**  **occupational exposure s.**  **]** 2. Infants and children

. **[ The proposed dicamba tolerances for**  **cotton undelinted seed and gin by** **- products**  **do not contribute**  **a significant**  **incremental dietary exposure to infants and children beyond that which has been previously**  **consider ed**  **by EPA. A conservative dietary exposure analysis (food plus water)**  **showed that exposure from all registered dicamba uses contribute**  **s only 11% aPAD**  **for the most highly exposed**  **population subgroup of infants less than one year old for acute exposure**  **, and**  **6. 7**  **% cPAD for**  **the most highly exposed population subgroup of**  **children 1 -**  **2 years old for chronic exposure (73FR 17914)**  **. Considering**  **the completeness of the overall toxicity database supporting this petition, there is reasonable certainty that no harm will result from**  **aggregate exposure arising from current and proposed dicamba uses including all anticipated dietary and non**  **** **occupational exposures .]**  F. International Tolerances **[ The current maximum residue limit (MRL) for cottonseed in Mexico is 0.2**  **ppm and 0.04 ppm at CODEX. There is no MRL for cottonseed in Canada. There**  **currently are no CODEX, Canadian, or Mexican MRLs for cotton gin by** **- products.**  **]**