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EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER EPA Registration Division contact: [insert name and telephone number with area code] 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: Clariant Corporation [Insert petition number] EPA has received a pesticide petition ([insert petition number]) from Clariant Corporation, 4000 Monroe Road, Charlotte, NC 28205 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. (Options (pick one) 1. NA-Remove by establishing a tolerance for residues of 2. to establish an exemption from the requirement of a tolerance for D-Glucitol, 1-deoxy-1-(methylamino)-, N-C8-10 acyl derivs. (CAS Reg. No. 1591782- 62-5) under 40 CFR § 180.910 when used as an inert ingredient (surfactant) not to exceed 40% in pesticide formulations applied pre- and post-harvest to all raw agricultural commodities . 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

. [NA-Remove. No specific plant metabolism data is available, nor is it required for the establishment of a tolerance exemption.] 2. Analytical method. [NA-Remove. An analytical method is not required forenforcement purposes since the Agency is establishing an exemption from the requirement of

a tolerance without any numerical limitation.]

3. Magnitude of residues. [NA-Remove. Information regarding the nature and magnitude of chemical residues resulting from the use of this inert ingredient is not required for the establishment of a tolerance exemption.]
B. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers including infants and children

. 1. Acute toxicity. C 8-10-Glucamide exhibits moderate toxicity by the oral route and no evidence of systemic toxicity via dermal or inhalation exposure under normal use conditions. The compound is severely irritating to the eyes but non-irritating to the skin and non-sensitizing. 2. Genotoxicty. C 8-10 -Glucamide showed no evidence of mutagenicity in bacteria or mammalian cells or induction of micronuclei in mice following oral exposure. 3. Reproductive and developmental toxicity. Oral administration of C 8-10-Glucamide. to rats in a guideline complainant reproductive and developmental screening study was without adverse effects on systemic, reproductive or developmental endpoints up to the highest dose tested (312.5 mg/kg bw/day). In addition, data on a structural analog, C 12-14 - Glucamide, produced no evidence of reproductive and developmental toxicity when examined in a one-generation reproductive study and FDA Segment II teratology study, both in rats, with no observed adverse effect levels (NOAELs) for these endpoints of 344.9 and 363 mg/kg bw/day, respectively. The parental and maternal NOAELs for these two studies were 147.8 and 150 mg/kg bw/day, respectively. 4. Subchronic toxicity. Oral administration of C 8-10-Glucamide to rats for 28-days resulted in a NOAEL of 250 mg/kg bw/day. Subacute and subchronic oral studies on the read-across compounds (C 12-14 -Glucamide) in rats had no observed effect levels (NOELs) of100 and 200 mg/kg bw/day, respectively. Furthermore, the systemic NOAEL from the onegeneration study in rats for the read-across compound was 147.8 mg/kg bw/day. These repeated dose toxicity studies, on either compound, did not indicate a clear target organ with main, consistent effects on body weight and food consumption, stress related findings, and findings related to the irritative nature of the compound/dosing regimen employed (bolus gavage dosing) including clinical findings and effects on the non-human relevant rat forestomach. 5. Chronic toxicity. There is no evidence that the C 8-10 -Glucamide would be a concern for chronic toxicity based on the limited effects observed in the repeated dose studies. In addition, no concern is noted for carcinogenicity based on the observation thatthe compound lack structural alerts for genotoxicity via DNA reactivity (covalent binding)

or non-genotoxic mechanisms. The prediction that the compounds lack of structural alerts is supported by the data (negative findings in genotoxicity assays). The conclusions regarding C 8-10 -Glucamide is further supported by the lack of mutagenicity observed in studies with C 12-14 -Glucamide. Lastly, analysis of the structures using in silico programs indicates a lack of concern for carcinogenicity. 6. Animal metabolism. C 8-10-Glucamide is expected to undergo enzymatic hydrolysis of the amide linkage catalyzed by fatty acid amide hydrolase. The resulting metabolites are meglumine , an amino sugar (normally derived from sorbitol) and fatty acids. Meglumine would be expected to be rapidly excreted in the urine and the fatty acids are metabolized via the general ß-oxidation pathway to generate acetyl-CoA. The projected metabolism was evaluated using accepted in silico programs. In addition, data are available regarding absorption, distribution, metabolism and elimination (ADME) of a surrogate Glucamide (C 12). These data indicate oral absorption of over 80% and dermal absorption of less than 1% of the administered dose; the major route of excretion is via the urine. 7. Metabolite toxicology . No concern is noted for the metabolites of C 8-10-Glucamide. Meglumine itself is acutely practically non-toxic, is not irritant to skin, not a skin sensitizer, is considered non-genotoxic, and is mainly unchanged rapidly excreted from the body while fatty acids are a normal component of the diet. 8. Endocrine disruption . C 8-10-Glucamide was negative for interaction with or binding to estrogen receptors as evaluated in the Estrogen Receptor Binding (Rat Uterine Cytosol, OPPTS 890.1250) assay. In addition, repeated dose studies did not indicate any adverse findings with regard to endocrine related parameters (histopathological or functional observations with regard to gonads, including fertility and maintenance of pregnancy as well as development of offspring). Furthermore, in silico evaluations of the target and source compound using DEREK found no concern for oestrogenicity, thyroid toxicity, and adrenal gland toxicity. As such, endocrine disruptive potential therefore is of low concern for C 8-10 -Glucamide.

C. Aggregate Exposure 1. Dietary exposure. The exposures numbers used to calculate the %cPAD are taken from the EPA review of similar surfactants, the Alkyl Alcohol Alkoxylates (AAA), which have similar use patterns to those covered in this petition.
Exposure (mg/kg/day) 100% Crop Treated, 40% Surfactant cPAD

1.50% cPAD General U.S. Population 0.153207 10 Infants (< 1 year old) 0.317666 21 Children 1-2 years old 0.499204 33 Children 3-5 years old 0.369566 25Children 6-12 years old 0.204248 14 Youth 13-19 years old 0.115298 8 Adults 20-49 years old 0.115521 8 Adults 50+ years old 0.121661 8 Females 13-49 years old 0.116311 8

i. Food. The dietary exposure above is the result of modeling to represent residues on food with 100% crop treated with a maximum concentration of 40% surfactant in the formulation. This is a worst case scenario, since it is expected that these materials will be used at a maximum percent crop treated of 1%. ii. Drinking water. In their review of another group of inerts, the Alkyl Alcohol Alkoxylates, EPA modeled expected drinking water concentrations and considered that the maximum concentration would be 100 parts per billion. This result is included in the exposure estimates in the dietary exposure table.

2. Non-dietary exposure . In examining aggregate exposure, section 408 of the FFDCA directs EPA to consider available information concerning exposures from the pesticide residue in food and all other non-occupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses). Because this petition is for use in pesticide formulations pre- and post-harvest to crops, the only expected exposure will be dietary.
D. Cumulative Effects We have not found a common mechanism of toxicity finding regarding C 8-10 - Glucamide and any other substances.
E. Safety Determination 1. U.S. population. Based on these risk assessments, there is a reasonable certainty that no harm will result to the general population or to infants and children from aggregate exposure to residues of C 8-10 -Glucamide. 2. Infants and children . Based on these risk assessments there is a reasonable certainty that no harm will result to the general population or to infants and children from aggregate exposure to residues of C 8-10-Glucamide.

F. International TolerancesClariant Corporation is not aware of any country requiring a tolerance for the

petitioned substances nor have any CODEX Maximum Residue Levels been established for any food crops at this time.