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EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: William Cutchin (703) 305 - 7990

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: Spring Trading Company

I N - 10674 EPA has received a pesticide petition IN - 10674 from Spring Trading Company, 10805 W est T i mberwagon Circle , Sprin g , TX 77380 - 4030 , on behalf of Croda, Inc. , 315 Cherry Lane, New Castle, DE 1 9720 request ing, 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. to establish an exemption from the requirement of a tolerance f or residues of the pol y mers polyoxyalkylated sorbitan fatty acid esters with C6 through C22 aliphatic alkanoic and/or alkenoic fatty acids, branched or linear, the resulting polyoxyalkylene sorbitan esters having a minimum molecular weight of 1000, used as dispersants, emulsifiers, surfactants, and related adjuvants of surfactants in or on the raw2

agricultural commodity growing crops pre - or post - harvest or in products to treat animals under 40 CFR 180.960 to include the following Chemic al Abstracts Services Registry N umbers:

CAS No.s CAS Name 81776 - 11 - 6 Sorbitan, monooctadecanoate. poly(oxy - 1,2 - ethanediyl)

poly[oxy(methyl - 1 ,2 - ethanediyl)] derivs. 87090 - 31 - 1 Sorbitan, monododecanoate, poly( oxy - 1,2 - ethanediyl)

poly[oxy(methyl - 1 ,2 - ethanediyl)] derivs. 88895 - 72 - 1 Sorbitan Mono - (9Z) - 9 - octadecenoate, poly(oxy - 1,2 - ethanediyl)

poly[oxy(methyl - 1 ,2 - ethanediyl)] derivs. 1472661 - 05 - 4 Sorbitan, (9Z) -- 9 - octadecenoate (2:3), poly(oxy - 1,2 - ethanediyl)

poly[oxy(methyl - 1,2 - ethanediyl)] derivs. 161026 - 53 - 5 Sorbitan monohexadecanoate, poly(oxy - 1,2 - ethanediyl)

poly[oxy(methyl - 1 ,2 - ethanediyl)] derivs. 103171 - 31 - 9 Sorbitan, tri - (9Z) -- 9 - octadecenoate, poly(oxy - 1,2 - ethanediyl)

poly[oxy(methyl - 1,2 - ethanediyl)] derivs 1472661 - 17 - 8 Sorbitan, trioctadecanoate, poly(oxy - 1 ,2 - ethanediyl)

poly[oxy(methyl - 1 ,2 - ethanediyl)] derivs. 1472668 - 03 - 3 Sorbitan, di - (9Z) -- 9 - octadecenoate, poly(oxy - 1,2 - ethanediyl)

poly[oxy(methyl - 1,2 - ethanediyl)] derivs 1472655 - 32 - 5 Oxirane, 2 - methyl - , polymer with oxirane, ether with 1,4 - anhydro D - glucitol (4:1), monooctadecanoate 1472663 - 59 - 4 Sorbitan monoisooctadecanoate, poly(oxy - 1,2 - ethanediyl)

poly[oxy(methyl - 1 ,2 - ethanediyl)] derivs 1472663 - 64 - 1 Sorbitan tri isooctadecanoate, poly(oxy - 1,2 - e thanediyl)

poly[oxy(methyl - 1,2 - ethanediyl)] derivs. 1472663 - 66 - 3 Sorbitan diisooctadecanoate, poly(oxy - 1,2 - ethanediyl)

poly(oxy(methyl - 1,2 - ethanediyl) ] derivs.3

1472663 - 92 - 5 Sorbitan isooctadecanoate, poly( oxy - 1,2 - ethanediyl)

poly[oxy(methyl - 1 ,2 - ethanediyl)] derivs. 1472654 - 83 - 3 Oxirane, 2 - methyl - , polymer with oxirane, ether with 1,4 - anhydro D - glucitol (4:1), monooctadecanoate 1472644 - 84 - 0 Fatty acids, C 6 - 10 , tetraesters with sorbitan, ethoxylated,

prop oxylated 1472644 - 85 - 1 Fatty acids, castor - oil, esters with sorbitan, ethoxylated ,

propoxylated 1472644 - 87 - 3 Fatty acids, castor - oil, hydrogenated, esters with sorbitan,

ethoxylated , propoxylated 1472644 - 88 - 4 Fatty acids, tall - oil, esters with sorbitan, ethoxylated , propoxylated 1472644 - 80 - 6 Fatty acids, tall - oil, monoesters with sorbitan, ethoxylated ,

propoxylated 1472644 - 81 - 7 Fatty acids, coco, monoesters with sorbitan, ethoxylated ,

propoxylated 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 befo re EPA rules on the petition. A. Residue Chemistry

1. Plant metabolism. Waived under the polymer exemption definition . 2. Analytical method. An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation.4

3. Magnitude of residues. Waived under the polymer exemption definition . B. Toxicological Profile The agency has reviewed 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 inf ants and children for the low risk polymer classification. These polymers of p olyoxyalkylat e d sorbitan fatty acid esters are not acutely toxic by the oral and dermal routes of exposure, or via inhalation under normal us e c onditions. Concentrated material s ar e generally not corrosive, eye and sk in irritants and not dermal sensiti z ers. There is no evidence .t h at the s e p olyoxyalkylated sorbitan fatty acid esters arc neurotoxic, m utagenic , or clastogenic. Specific information on the studies evaluated and th e nature of the ad verse e ffec ts findings by the Agency for the polymers of p olyoxyalkylated sorbitan fatty a cid esters as well as the no obs e rved - adv e rse - eff e ct - level (NOAEL) and the lowe s t observed adverse - e ffect - level (LOAEL) from th e toxicity studies ca n be found at http://www.re gulations.gov documents allowing the approval of defined low ris k polymeric compounds.

1. Acute toxicity. Waived under the polymer exemption definition . 2. Genotoxicty. Waived under the polymer exemption definition . 3. Reproductive and developmental toxicity. Waived under the polymer exemption definition .5

4. Subchronic toxicity. Waived under the polymer exemption definition . 5. Chronic toxicity. There is no evidence that the polymers of p olyoxyalkylated sorbitan fatty acid esters are carcinogenic. There was little concern about any of the postulated metabolites having greater toxici t y than the parent compounds.)

6. Animal metabolism. Waived under the polymer exemption definition . 7. Metabolite toxicology . Wai ved under the polymer exemption definition . 8. Endocrine disruption . FQPA requires EPA to develop a screening program to determine whether certain substances, including all pesticide chemicals (both inert and active ingredients), "may have an effect in humans that is similar to a n effect produced by a naturally occurring estrogen, or such other endocrine effect..." EPA has been working with interested stakeholders to develop a screening and testing program as well as a priority setting scheme. As the Age ncy proceeds with implementation of this program, further testing of products containing the polymers of p o l yoxyalkylated sorbitan fatty acid esters for endocrine effects may be required. This class of chemistry does not belong to a class of chemicals know n or suspected of having adverse effects on the estrogen receptor or endocrine system . C. Aggregate 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 (resi dential and other indoor uses).6 EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be demonstrated that the risks from aggr e gate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In or der to det ermine the risks from aggregat e exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient t hrough food, drinking water, and through other exposures that occur as a result of p esticide use in residential settings. If EPA is able to determi ne that a finite tolerance is no t necessary to ensure that there is a reasonable certainty that no harm will resu lt from aggregate exposure to the inert ingredient, an ex emption from the requirement of a tolerance may be established. The polymers of p o l yoxyalkylated sorbitan fatty acid esters proposed use as inert ingredients in pesticide products that are currently registered for uses that could result in intermediate - term residential exposure and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with intermediate term residential exposures to the polymers of Poiyoxyalkylated sorbitan fatty acid esters 

### . D . Cumulative Effects Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of safety finding as to polymers of pol yoxyalkylated sorbitan fatty acid ester s with and any other substances. The polymers of pol yoxyalkylated sorbitan fatty acid esters appear to produce no toxic metabolites produced by other substances. E. Safety Determination

1. U.S. population. Based on these risk assessments, Croda, Inc. concludes that there is a reasonable certainty that no harm will result to the general population from7

aggregate exposure to residues of the polymers of p olyoxyalkyla ted sorbitan fatty acid esters.

2. Infants and children . B ased on these risk assessments , Croda, Inc. concludes that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to residues of polymers of p olyoxyalkylated sorbitan fatty acid esters. F. International Tolerances Croda, Inc. is not aware of any country requiring a tolerance for the polymers p olyoxyalkylated sorbitan fatty acid esters nor have any CODEX Maximum Residue Levels been established for any food crops at this time.