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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

TEMPLATE:

Croda, Inc.

IN‐10658

EPA has received a pesticide petition IN‐10658 from Spring Trading Co., 10805 

W. Timberwagon Cir., Spring, TX 77380-4030, on behalf of Croda, Inc., 315 Cherry

Lane, New Castle DE, 19720, 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 180.960 to

establish an exemption from the requirement of a tolerance for polyoxyalkylated

trimethylopropanes with 20 to 80 moles of ethylene and/or propylene oxide, fatty

acid esters with C8 through C22 aliphatic alkanoic and/or alkenoic fatty acids,

branched or linear, the resulting polyoxyalkylene trimethylopropane esters having a

minimum molecular weight of 1,500 in or on growing crops, pre or post‐harvest or in

products to treat animals. The requested CAS Nos. are: 25765‐36‐0; 29860‐47‐7;

37339‐03‐0; 52624‐57‐4; 58090‐24‐7; 63964‐38‐5; 72939‐62‐9; 74521‐14‐5; 75300‐70‐8;

75300‐90‐2; 84271‐03‐4; 84271‐04‐5; 86850‐92‐2; 107120‐02‐5; 133331‐01‐8; 137587‐

60‐1; 149797‐40‐0; 149797‐41‐1; 150695‐97‐9; 152130‐24‐0; 163349‐94‐8; 163349‐95‐

9; 163349‐96‐0; 163349‐97‐1; 163349‐98‐2; 165467‐70‐9; 183619‐46‐7; 183619‐50‐3;
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185260‐01‐9; 202606‐04‐0; 210420‐84‐1; 233660‐70‐3; 263011‐96‐7; 283602‐94‐8;

701980‐40‐7; 872038‐58‐9; 875709‐44‐7; 875709‐45‐8; 875709‐46‐9; 875709‐47‐0;

879898‐63‐2; 910038‐01‐6; 1190748‐04‐9; 1225384‐02‐0; 1428944‐41‐5; and 1446498‐

15‐2.

   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.

3. Magnitude of residues. Waived under the polymer exemption definition.

B. Toxicological Profile

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 polyoxyalkylated trimethylopropane polymers 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

trimethylopropane polymers are neurotoxic, mutagenic, or clastogenic. Specific

information on the studies evaluated and the nature of the adverse effects findings by

polyoxyalkylated trimethylopropane‐type polymers as well as the no observed‐ 

adverse‐effect‐level (NOAEL) and the lowest‐observed‐adverse‐effect‐level (LOAEL)
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from the toxicity studies can be found at http://www.regulations.gov in 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.

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

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

trimethylopropanes 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

polyoxyalkylated trimethylopropanes 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
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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). 

 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 polyoxyalkylated trimethylopropanes are used 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 polyoxyalkylated 

trimethylopropanes.

D. Cumulative Effects

The Agency has not found a common mechanism of toxicity finding as to 

polyoxyalkylated trimethylopropanes and any other substances. Polyoxyalkylated 

trimethylopropanes do not appear to produce a toxic metabolite produced by other 

substances. For the purposes of this requested tolerance action polyoxyalkylated 

trimethylopropanes do not have a common mechanism of toxicity with 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 or to infants and children from aggregate exposure to residues of the 

polyoxyalkylated trimethylopropanes.
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2. Infants and children. Based on these risk assessments, Croda, Inc. 

concludes that 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 polyoxyalkylated trimethylopropanes.

F. International Tolerances

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

polyoxyalkylated trimethylopropanes nor have any CODEX Maximum Residue 

Levels been established for any food crops at this time.