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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 replace the instructions that appear in green, i.e., “[insert company 

name],” with the information specific to your action.

TEMPLATE:

Spring Trading Company

IN-10674

EPA has received a pesticide petition IN-10674 from Spring Trading Company, 

10805 West Timberwagon Circle, Spring, TX 77380-4030, on behalf of Croda, Inc., 315 

Cherry Lane, New Castle, DE 19720 requesting, 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 for residues of the 

polymers 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 raw 
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agricultural commodity growing crops pre- or post-harvest or in products to treat 

animals under 40 CFR 180.960 to include the following Chemical Abstracts Services 

Registry Numbers:

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-anhydroD-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 triisooctadecanoate, poly(oxy-1,2-ethanediyl) 

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

1472663-66-3 Sorbitan diisooctadecanoate, poly(oxy-1,2-ethanediyl) 

poly(oxy(methyl-1,2-ethanediyl)] derivs.
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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-anhydroD-glucitol (4:1), monooctadecanoate

1472644-84-0 Fatty acids, C 6-10, tetraesters with sorbitan, ethoxylated, 

propoxylated

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 before 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.
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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 infants and 

children for the low risk polymer classification.

These polymers of polyoxyalkylated sorbitan fatty acid esters are not acutely 

toxic by the oral and dermal routes of exposure, or via inhalation under normal use 

conditions. Concentrated materials are generally not corrosive, eye and skin irritants 

and not dermal sensitizers. There is no evidence .that these polyoxyalkylated sorbitan 

fatty acid esters arc neurotoxic, mutagenic, or clastogenic.

Specific information on the studies evaluated and the nature of the adverse 

effects findings by the Agency for the polymers of polyoxyalkylated sorbitan fatty acid 

esters as well as the no observed-adverse-effect-level (NOAEL) and the lowest observedadverse-effect-level (LOAEL) from the toxicity studies can be found at

http://www.regulations.gov documents allowing the approval of defined low risk 

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.
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4. Subchronic toxicity. Waived under the polymer exemption definition.

5. Chronic toxicity. There is no evidence that the polymers of polyoxyalkylated 

sorbitan fatty acid esters are carcinogenic. There was little concern about any of the 

postulated metabolites having greater toxicity than the parent compounds.)

6. Animal metabolism. Waived under the polymer exemption definition.

7. Metabolite toxicology. Waived 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 an 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 Agency proceeds with implementation of this 

program, further testing of products containing the polymers of polyoxyalkylated 

sorbitan fatty acid esters for endocrine effects may be required. This class of chemistry 

does not belong to a class of chemicals known 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 

(residential and other indoor uses).
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EPA establishes exemptions from the requirement of a tolerance only in those 

cases where it can be demonstrated that the risks from aggregate exposure to pesticide 

chemical residues under reasonably foreseeable circumstances will pose no appreciable 

risks to human health. In order to determine the risks from aggregate exposure to 

pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction 

with possible exposure to residues of the inert ingredient through food, drinking water, 

and through other exposures that occur as a result of pesticide use in residential 

settings. If EPA is able to determine that a finite tolerance is not necessary to ensure 

that there is a reasonable certainty that no harm will result from aggregate exposure to 

the inert ingredient, an exemption from the requirement of a tolerance may be 

established.

The polymers of polyoxyalkylated 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 intermediateterm 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 polyoxyalkylated sorbitan fatty acid esters with and any 

other substances. The polymers of polyoxyalkylated 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 from 
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aggregate exposure to residues of the polymers of polyoxyalkylated sorbitan fatty acid 

esters.

2. Infants and children. Based 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 polyoxyalkylated sorbitan fatty acid 

esters.

F. International Tolerances

Croda, Inc. is not aware of any country requiring a tolerance for the polymers

polyoxyalkylated sorbitan fatty acid esters nor have any CODEX Maximum Residue 

Levels been established for any food crops at this time.