


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 [soybean, forage] at [45] parts per million (ppm) and [soybean, hay] 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 dicamba-tolerant soybean is adequately understood.  The primary route of metabolism of dicamba in dicamba-tolerant soybean is by demethylation to form DCSA and subsequent hydroxylation to form the minor metabolite DCGA (3,6-dichlorogentisic acid).  DCSA and its glucose conjugates are the major metabolites from both pre and postemergence applications of dicamba to dicamba-tolerant soybean.  Parent dicamba comprises a significant portion of the residue in both soybean forage and hay for postemergence applications.  DCGA and its conjugates are present only at low levels in soybean forage and hay.  EPA has previously determined that the dicamba residues of concern for soybean commodities are dicamba, DCSA, and 5-OH dicamba. Based on the results of the dicamba-tolerant soybean metabolism study, the current tolerance expression is adequate for soybean forage and hay.]

	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 soybean forage and hay.]

	3. Magnitude of residues. [Residue data are available for residues of dicamba in dicamba-tolerant soybean.  Residues in soybean forage ranged from 10.0 to 51.2 ppm with a median of 15.2 ppm.  Residues in soybean hay ranged from 12.2 to 61.1 ppm with a median residue of 31.9 ppm.  These data show that residues of dicamba resulting from proposed labeled uses of dicamba in dicamba-tolerant soybean will not exceed the proposed tolerances for soybean, forage at 45 ppm and soybean, hay at 70 ppm. In addition, the proposed tolerances for dicamba in soybean forage and hay will not result in secondary residues in meat and milk above the tolerances already published at 40 CFR 180.227.]


B. Toxicological Profile
[EPA has previously evaluated available toxicology data on dicamba and concluded the data are of sufficient quality and reliability 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 on sweet corn commodities (Federal Register: April 2, 2008, Vol. 73, No. 64, p. 17914-18; Petition No. 0E6209; Decision: 304187; EPA-HQ-OPP-2007-0325).]

	1. Acute toxicity.  [As noted in Dicamba RED, 2006 and Decision 304187.]

	2. Genotoxicity. [As noted in Dicamba RED, 2006 and Decision 304187.]

	3. Reproductive and developmental toxicity. [As noted in Dicamba RED, 2006 and Decision 304187.]

	4. Subchronic toxicity. [As noted in Dicamba RED, 2006 and Decision 304187.]

	5. Chronic toxicity. [As noted in Dicamba RED, 2006 and Decision 304187.]

	6. Animal metabolism. [As noted in Dicamba RED, 2006 and Decision 304187.]

	7. Metabolite toxicology. [Toxicity studies on DCSA and DCGA have been conducted to further characterize their toxicity. Overall, only a few minor quantitative and qualitative differences in toxicity were observed when comparing DCSA, DCGA and dicamba. These data demonstrate that the overall toxicity profiles of dicamba and its metabolites, DCSA and DCGA, are substantially similar and that neither DCSA nor DCGA present any new or unusual toxicity concerns beyond what has already been considered for parent dicamba.  Therefore, existing dicamba toxicity endpoints are sufficient to assess potential health risks from exposure to DCSA and DCGA metabolites.  

	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 tolerances of dicamba in soybean forage and soybean hay. In addition, the proposed new use that supports the soybean forage and hay tolerances does not result in an increase in estimated drinking water exposure beyond what has already been evaluated by EPA. Consequently, no incremental dietary (food plus water) exposure to dicamba is anticipated from the proposed tolerances, and the most recent EPA dietary exposure assessment supporting dicamba tolerances for sweet corn commodities (Federal Register: April 2, 2008, Vol. 73, No. 64, p. 17914-18; Petition No. 0E6209; Decision: 304187) is adequate to support the proposed tolerances on soybean forage and hay.]

	i. Food. [In support of the proposed tolerances for sweet corn commodities, 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.  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 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.]

	ii. Drinking water. [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 exposure from drinking water were combined with 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 (Federal Register: April 2, 2008, Vol. 73, No. 64, p. 17914-18; Petition No. 0E6209; Decision: 304187).  Non-dietary exposure to dicamba did not exceed the Agency's level of concern.]

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 soybean forage and soybean hay do not pose any 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 (Federal Register: April 2, 2008, Vol. 73, No. 64, pages 17914-18; Petition No. 0E6209; Decision No. 304187).  Dietary exposure 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 soybean forage and soybean hay do not pose any 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. 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

	[There currently are no CODEX, Canadian or Mexican maximum residue limits (MRLs) for residues of dicamba on soybean forage or hay.]

