


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 replace 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 metabolites 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 major metabolites 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 commodities, including dicamba-tolerant cotton,  is: dicamba, DCSA and 5-hydroxydicamba, 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 cottonseed 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 0.17 to 1.72 ppm, with a median of 0.54 ppm.  Cotton gin 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 Eligibility Decision (RED) and as part of a recent action to establish tolerances 76 FR 55804. 

	1. Acute toxicity.  [NA-remove]

	2. Genotoxicity. [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. These 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.  Therefore, the established dicamba toxicity endpoints are sufficient to assess potential health risks from dietary exposure to DCSA metabolite.}  

	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 increases for dicamba in cottonseed and gin by-products. In addition, the proposed new use on MON 88701 cotton does not result in an increase in estimated drinking water exposure beyond that 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 proposed 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 subpopulation 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 exposure levels.]

	ii. Drinking water. [In support of the proposed 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 exposures 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 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

	[EPA 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 considered by EPA as part of previous regulatory actions.  A conservative dietary exposure analysis (food plus water) was conducted for dicamba in support of the proposed tolerances for sweet corn commodities (73 FR 17914).  In that assessment, dietary 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 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.]

	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 considered by EPA.  A conservative dietary exposure analysis (food plus water) showed that exposure from all registered dicamba uses contributes 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.]

