Document ID: EPA-HQ-OPP-2016-0201-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2016-05-19T04:00Z

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

EPA Registration Division contact: Kerry Leifer 703-308-8811

TEMPLATE:

Trinseo LLC

[IN-10907]

	EPA has received a pesticide petition (IN-10907) from Trinseo LLC, c/o
Keller and Heckman LLP, 1001 G Street, NW, Suite 500 West, Washington,
DC 20001 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
butanedioic acid, 2-methylene-, polymer with 1,3-butadiene,
ethenylbenzene and 2-hydroxyethyl 2-propenoate with an average molecular
weight of greater than 10,000 daltons (CAS Reg. No. 36089-06-2) under 40
CFR §180.960 in or on raw agricultural commodities when used as a
pesticide inert ingredient in pesticide formulations without limitation.
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. NA-Remove. No specific plant metabolism data is
available, nor is it required for the establishment of a tolerance
exemption.

	2. Analytical method. NA-Remove. 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. NA-Remove. Information regarding the nature
and magnitude of chemical residues resulting from the use of this inert
ingredient is not required for the establishment of a tolerance
exemption.

B. Toxicological Profile

Butanedioic acid, 2-methylene-, polymer with 1,3-butadiene,
ethenylbenzene and 2-hydroxyethyl 2-propenoate is a polymer as defined
by 40 CFR 723.250(b).

Butanedioic acid, 2-methylene-, polymer with 1,3-butadiene,
ethenylbenzene and 2-hydroxyethyl 2-propenoate will not become cationic
in an aquatic environment.

Butanedioic acid, 2-methylene-, polymer with 1,3-butadiene,
ethenylbenzene and 2-hydroxyethyl 2-propenoate is composed of hydrogen,
oxygen, and carbon: therefore, it meets the criteria of elemental
composition.

Butanedioic acid, 2-methylene-, polymer with 1,3-butadiene,
ethenylbenzene and 2-hydroxyethyl 2-propenoate does not contain as an
integral part of its composition, except as impurities, any element
other than those listed in 40 CFR 723.250(d)(2)(ii).

Butanedioic acid, 2-methylene-, polymer with 1,3-butadiene,
ethenylbenzene and 2-hydroxyethyl 2-propenoate is not designed nor
reasonably expected to degrade, decompose, or depolymerize under normal
conditions of manufacture, use and disposal. 

Butanedioic acid, 2-methylene-, polymer with 1,3-butadiene,
ethenylbenzene and 2-hydroxyethyl 2-propenoate is composed of molecules
that are listed on the TSCA Inventory or manufactured under an
applicable TSCA section 5 exemption.

Butanedioic acid, 2-methylene-, polymer with 1,3-butadiene,
ethenylbenzene and 2-hydroxyethyl 2-propenoate is not a water absorbing
polymer and cannot absorb its own weight in water.

Butanedioic acid, 2-methylene-, polymer with 1,3-butadiene,
ethenylbenzene and 2-hydroxyethyl 2-propenoate does not contain any
perfluoroalkyl moieties consisting of a CF3- or longer chain length as
specified in 40 CFR 723.250(d)(6). 

Butanedioic acid, 2-methylene-, polymer with 1,3-butadiene,
ethenylbenzene and 2-hydroxyethyl 2-propenoate consists of a number
average molecular weight of greater than 10,000 daltons.

	1. Acute toxicity.  NA-Remove

	2. Genotoxicty. NA-Remove

	3. Reproductive and developmental toxicity. NA-Remove

	4. Subchronic toxicity. NA-Remove

	5. Chronic toxicity. NA-Remove

	6. Animal metabolism. NA-Remove

	7. Metabolite toxicology. NA-Remove

	8. Endocrine disruption. NA-Remove

C. Aggregate Exposure

	1. Dietary exposure. The physical-chemical characteristics of
butanedioic acid, 2-methylene-, polymer with 1,3-butadiene,
ethenylbenzene and 2-hydroxyethyl 2-propenoate leads to the conclusion
that there is a reasonably certainty of no harm from exposure to the
polymer from food or drinking water nor from an aggregate exposure. 

	i. Food. NA-Remove

	ii. Drinking water. NA-Remove

	2. Non-dietary exposure. The physical-chemical characteristics of
butanedioic acid, 2-methylene-, polymer with 1,3-butadiene,
ethenylbenzene and 2-hydroxyethyl 2-propenoate lead to the conclusion
that there is a reasonable certainty of no harm from exposure to the
polymer from non-dietary means. 

D. Cumulative Effects

	At this time there is no information to indicate that any toxic effects
produced by butanedioic acid, 2-methylene-, polymer with 1,3-butadiene,
ethenylbenzene and 2-hydroxyethyl 2-propenoate would by cumulative with
any other chemical. Given the compound’s categorization as a low risk
polymer, and its proposed use in pesticide formulations, there is no
expectation of increased risk due to cumulative exposure.

E. Safety Determination

	1. U.S. population. Based on the polymer’s physical-chemical
properties, and that it meets or exceeds the polymer exemption criteria
at 40 CFR 723.250 for low-risk polymers, adverse effects are not
expected.

	2. Infants and children. Based on the polymer’s physical-chemical
properties, and that it meets or exceeds the polymer exemption criteria
at 40 CFR 723.250 for low-risk polymers, adverse effects are not
expected.

F. International Tolerances

The Codex Alimentarius Commission (Codex) has not established a MRL for
butanedioic acid, 2-methylene-, polymer with 1,3-butadiene,
ethenylbenzene and 2-hydroxyethyl 2-propenoate and there are no maximum
residue limits established for butanedioic acid, 2-methylene-, polymer
with 1,3-butadiene, ethenylbenzene and 2-hydroxyethyl 2-propenoate in or
on crops or commodities of which the petitioner is aware.

4819-9536-0301, v.  1

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