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EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER EPA Registration Division contact: PV Shah, 703 - 308 - 1846 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: Ecolab, Inc. [Insert petition number] EPA has received a pesticide petition ( [insert petition number] ) from Ecolab, Inc., EPA Company Number 1677, 370 N. Wabasha Street, St. Paul, MN 55102 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) 2. to establish an exempt ion from the requirement of a tolerance for Sorbitan, mono - 9 - octadecenoate, poly(oxy - 1,2 - ethanediyl) derivs., (Z) - , CAS No. 9005

- 65

- 6 for use as an inert ingredient in antimicrobial pesticide formulations applied to food

- contact surfaces in public eating places, dairy processing equipment and food processing equipment and utensils in accordance with 40 CFR §180.940(a) . EPA has determin ed 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 befo re EPA rules on the petition. A. Residue Chemistry 1. Plant metabolism. Not applicable to this inert ingredient petition 2. Analytical method. Not applicable to this inert ingredient petition 3. Magnitude of residues. Not applicable to this inert ingredient petition2 B. Toxicological Profile 1. Acute toxicity. Sorbitan, mono - 9 - octadecenoate, poly(oxy - 1,2 - ethanediyl) derivs., (Z) - , is shown to be of low acute toxicity
. Acute o ral LD 50 values are greater than 25 ,000 mg/kg. Due to its large molecular size, dermal absorption is not expected and due to low volatility, in h alation exposure is also expected to be minimal. It is not irritating to skin or eyes. 2. Genotoxic i ty. I n previous reassessment of polysorbate tolerance exemptions, the Agency cited a report from the Cosmetic Ingredient Review (CIR) that stated that the polysorbates were nonmutagenic or genotoxic in a number of bacterial and mammalian systems
. 3. Reproduct ive and developmental toxicity. I n previous reassessment of polysorbate tolerance exemptions, the Agency’s review of developmental and reproductive toxicity of the polysorbates noted there were no harmful effects on prenatal development and no adverse repr oductive effects. 4. Subchronic toxicity. I n pr evious reassessment of polysorbate tolerance exemptions, the Agency’s review of feeding studies with polysorbates indicated no adverse effects, except at high levels where diarrhea was observed due to the indigestibility of the material. Dermal and inhalation are not exposures of concern. 5. Chronic toxicity. I n previous reassessment of polysorbate tolerance exemptions, the Agency’s review of feeding studies with polysorbates indicated no adverse effects, except at high levels where diarrhea was observed due to the indigestibility of the material. Dermal and inhalation are not exposures of concern
. A variety of oral studie s conducted on multiple animal species showed no evidence of carcinogenicity. 6. Animal metabolism. Polysorbates are hydrolyzed to a fatty acid moiety and a polyoxyethylene moiety. The fatty acid moiety is rapidly absorbed and oxidized, the majority bei ng expired as carbon dioxide. The polyoxyethylene moiety is poorly absorbed in the gastrointestinal track and is primarily (90%) excreted in the feces. 7. Metabolite toxicology
. The re are no metabolites of toxicological concern. 8. Endocrine disruption
. EPA did not report having any available information to suggest that polysorbates, including s orbitan, mono - 9 - octadecenoate, poly(oxy - 1,2 - ethanediyl) derivs., (Z) - , would have any endocrine effects. When the appropriate screening and/or testing protocols under the EDSP have b een developed, s orbitan, mono - 9 - octadecenoate, poly(oxy - 1,2 - ethanediyl) derivs., (Z) - may be subject to additional screening and/or testing to better characterize effects related to endocrine disruption. This does not impact the current regulatory status of s orbitan, mono - 9 - octadecenoate, poly(oxy - 1,2 - ethanediyl) derivs., (Z) - .3

C. Aggregate Exposure 1. Dietary exposure. I n previous reassessment of polysorbate tolerance exemptions , including s orbitan, mono - 9 - octadecenoate, poly(oxy - 1,2 - ethanediyl) derivs., (Z) - , the Agency determined that dietary exposure to polysorbates occurs primarily from foods where it is used as an additive. Additional exposure could also come from s orbitan, mono - 9 - octadecenoate, poly( oxy 1,2 - ethanediyl) derivs., (Z) - use in food packaging and drugs. Because the potential dietary exposures from use of polysorbates as inert ingredients in pesticide formulations is expected to be so much less than from direct and indirect food additive u ses, the Agency concluded no further dietary assessment was necessary. i. Food. Primary sources for exposure to s orbitan, mono - 9 - octadecenoate, poly(oxy - 1,2 - ethanediyl) derivs., (Z) - from food will come from its use as a direct food additive. Additional sources of exposure, including use as an inert ingredient in pesticide formulations will be relatively minimal. ii. Drinking water . In the previous reassessment of polysorbate tolerance exemptions, including s orbitan, mono - 9 - octadecenoate, poly(oxy - 1,2 - ethanediyl) derivs., (Z) - , the Agency concluded that polysorbates were unlikely to be present in the environment at any appreciable levels whe n used as a pesticide inert ingredient. Any contribution to exposure from drinking water would be unlikely. 2. Non

- dietary exposure
. Residential exposure could come from use of s orbitan, mono - 9 - octadecenoate, poly(oxy - 1,2 - ethanediyl) derivs., (Z) - in consumer products, including pesticide products and from cosmetics and personal care products. Inhalation is very unlikely route of exposure due to the low volatility. The most likely residential exposure to s orbitan, mono - 9 - octadecenoate, poly(oxy - 1 ,2 - ethanediyl) derivs., (Z) - from use in pesticide formulations is dermal, but there is little concern for human health, based on lack of dermal absorption or irritation. D. Cumulative Effects EPA has not made a common mechanism of toxicity finding for p olysorbates, including s orbitan, mono - 9 - octadecenoate, poly(oxy - 1,2 - ethanediyl) derivs., (Z) - , and they do not produce toxic metabolites for consideration with other substances. E. Safety Determination 1. U.S. population. As part of the FQPA tolerance reassessment process, EPA concluded that taking into consideration all available information on s orbitan, mono - 9 - octadecenoate, poly(oxy - 1,2 - ethanediyl) derivs., (Z) - , including its long history of use in food, cosmetics and p ersonal care products, that there was reasonable certainty of no harm to all population subgroups as a result of aggregate exposure to polysorbates from dietary and other non

occupational sources of exposure from use in pesticide products.4 The Agency also determined that the established exemptions from the requirement for a tolerance for the polysorbates for current uses met the safety standards under the FQPA amendments to section 408(b)(2)(D) of the FFDCA. The inclusion of the uses supported by expa nding the tolerance exemption to include uses cited at 40 CFR § 180.940(a) would not change this determination. 2. Infants and children
. EPA previously determined that the established exemptions from a requirement for a tolerance for polysorbates met the safety standards under the FQPA amendments to section 408(b)(2)(C) of the FFDCA, and that there was a reasonable certainty of no harm for infants and children. The safety determination for infants and children considers factors of the toxicity, use pract ices, and environmental behavior noted above for the general population, but also takes into account the possibility of increased dietary exposure due to the specific consumption patterns of infants and children, as well as the possibility of increased sus ceptibility to the toxic effects of polysorbate residues in this population subgroup. The Agency concluded in their assessment of the polysorbates that there was no concern for increased sensitivity to infants and children. In addition, a safety factor an alysis was not employed to assess risk, and therefore a 10X FQPA Safety Factor is unnecessary. The inclusion of the uses supported by expanding the tolerance exemption to include uses cited at 40 CFR § 180.940(a) would not change this determination. F. International Tolerances Currently , there are no Codex MRLs established for s orbitan, mono - 9 - octadecenoate, poly(oxy - 1,2 - ethanediyl) derivs., (Z) - .