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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;2

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)3

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 Exposure4

In examining aggregate exposure, s ection 408 of the FFDCA directs EPA to

consider available information concerning ex posures from the pesticide residue in

food and all other non-occupational expo sures, including drinking water from

ground water or surface water and expo sure 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 or der to determine the risks from aggregate

exposure to pesticide inert ingr edients, the Agency consider s the toxicity of the inert

in conjunction with possible exposure to residues of the inert ingredient through

food, drinking water, and through other expo sures 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 reaso nable certainty that no harm will result

from aggregate exposure to the inert ingred ient, 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 regis tered 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 ex posures 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 reque sted tolerance acti on polyoxyalkylated

trimethylopropanes do not have a commo n mechanism of toxicity with other

substances

.

E. Safety Determination

1. U.S. population. 

### Based on these risk assessme nts, Croda, Inc. concludes

that there is a reasonable certainty that no harm w ill result to the general

population or to infants and children from aggregate exposure to residues of the

polyoxyalkylated trimethylopropanes.5

2. Infants and children

. 

### Based on these risk assessments, Croda, Inc.

concludes that there is a reasonable cert ainty that no harm will result to the

general population or to infants a nd children from aggregate exposure to

residues of polyoxyalkylated trimethylopropanes.

F. International Tolerances



### Croda, Inc. is not aware of any co untry requiring a tolerance for the

polyoxyalkylated trimethylopropanes no r have any CODEX Maximum Residue

Levels been established for an y food crops at this time.