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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 

replace 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 exemption 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 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. 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 petition
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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 oral LD50 values are greater than 25,000 mg/kg. Due 

to its large molecular size, dermal absorption is not expected and due to low volatility, inhalation 

exposure is also expected to be minimal. It is not irritating to skin or eyes.

2. Genotoxicity. In 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. Reproductive and developmental toxicity. In 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 

reproductive effects.

4. Subchronic toxicity. In 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.

5. Chronic toxicity. In 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 studies 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 

being 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. There are no metabolites of toxicological concern.

8. Endocrine disruption. EPA did not report having any available information to suggest 

that polysorbates, including sorbitan, 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 been developed, sorbitan, 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 sorbitan, mono-9-

octadecenoate, poly(oxy-1,2-ethanediyl) derivs., (Z)-.
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C. Aggregate Exposure

1. Dietary exposure. In previous reassessment of polysorbate tolerance exemptions,

including sorbitan, 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 sorbitan, mono-9-octadecenoate, poly(oxy1,2-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 uses, the Agency concluded no 

further dietary assessment was necessary.

i. Food. Primary sources for exposure to sorbitan, 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 sorbitan, 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 when 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 sorbitan, 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 sorbitan, 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 polysorbates, including sorbitan, 

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 sorbitan, mono-9-octadecenoate, 

poly(oxy-1,2-ethanediyl) derivs., (Z)-, including its long history of use in food, cosmetics and 

personal 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 nonoccupational sources of exposure from use in pesticide products. 
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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 

expanding 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 practices, 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 

susceptibility 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 analysis 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 sorbitan, mono-9-octadecenoate, poly(oxy-1,2-

ethanediyl) derivs., (Z)-.