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

EPA Registration Division contact: [Mr. Mark Dow, 703

- 305
- 5533 ]

H.B. Fuller Company

2E8033

EPA has received a pesticide petition 2E8033 from H.B. Fuller Company , 1200 Willow Lake Boulevard, Saint Paul, MN 55101 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. 9 60 to approve an Inert Ingredient Low Risk Polymer Exemption for 2
- Propenoic Acid, 2

- Ethylhexyl Ester, Polymer with Ethenylbenzene [8900 amu], [CAS # 25153

- 46
- 2] as an approved inert binder for antimicrobial pesticide formulation
. EPA has determined that t he 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. Additi onal data may be needed before EPA rules on the petition.

A. Residue Chemistry
1. Plant metabolism. [N/A

- REMOVE ]
2. Analytical method. [N/A

- REMOVE ]
3. Magnitude of residues. [N/A

- REMOVE ]

B. Toxicological Profile2

a. 2

- Propenoic Acid, 2

- Ethylhexyl Ester, Polymer with Ethenylbenzene is a polymer as defined by 40 CFR 723.250(b) . It is composed of at least 3 monomer units and two other reactant s . In addition, 2

- Propenoic Acid, 2

- Ethylhexyl Ester, Polymer wi th Ethenylbenzene comprises the majority of the polymer molecular weight . The monomer sequences form uninterrupted strings in the polymer and the molecular weight distribution of the polymer is due to the difference in polymer chain lengths.
b. 2

- Propenoic Acid, 2

- Ethylhexyl Ester, Polymer with Ethenylben zene consists of a number average molecular weight greater than 1 000 Da (Daltons).

c. 2

- Propenoic Acid, 2

- Ethylhexyl Ester, Polymer with Ethenylbenzene is not a cationic polymer , nor is it reasonably expected to become a cationic polymer in a natural aquatic environment.
d. The polymer does contain as an integral part of its composition the atomic elements carbon, hydrogen , and oxygen.

e. The polymer does not contain as an integral part of its composition, except as impurities, any elements other than those listed i n 40 CFR 273.250(d)(2)(ii).
f. The polymer is neither designed nor can it be reasonably anticipated to substantially degrade, decompose, or depolymerize.

g. The polymer is manufactured from reactants that are already included in the TSCA Chemical Substances Inventory.
h. The polymer is not a water absorbing polymer with a number average molecular weight (MW) greater than or equal to 10,000 Dalton. Additional, the polymer 2

- Propenoic Acid, 2

- Ethylhexyl Ester, Polymer with Ethenylbenzene, also meets as required the following exemption criteria specified in 40 CFR 723.250(b). The polymer is not designed to be a water absorbing polymer that is capable of absorbing its weight of water.

Thus, 2

- Propenoic Acid, 2

- Ethylhexyl Ester, Polymer with Ethenylbenzene meets a ll the criteria for a polymer to be considered a l ow risk under 40 CFR 273.250. Based on its conformance to all the above criteria, no mammalian toxicity is anticipated from dietary, inhalation, or dermal exposure to 2

- Propenoic Acid, 2

- Ethylhexyl Ester, Polymer with Ethenylbenzene.

C. Aggregate Exposure3

For purposes of assessing potential exposure under this exemption, 2

- Propenoic Acid, 2

- Ethylhexyl Ester, Polymer with Ethenylbenzene could be present in all raw and processed agricultural commodities and drinking water, and that non

- occupational non

- dietary exposure was possible. The number average MW of 2

- Propenoic Acid, 2

- Ethylhexyl Ester, Polymer with Ethenylbenzene is greater than 1000 Daltons. Generally a polymer of this size would be poorly abs orbed through the intact gastrointestinal tract or through intact human skin. Since 2

- Propenoic Acid, 2

- Ethylhexyl Ester, Polymer with Ethenylbenzene conforms to the criteria that identify a low risk polymer there are no concerns with risks associated wit h any potential exposure scenarios that are reasonably foreseeable . Therefore a tolerance is not necessary to protect public health.

D. Cumulative Effects

Section 408 (b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, o r revoke a tolerance or tolerance exemption, “available information” concerning the
c umulative effects of a particular chemical’s residue and “other substances that have a common method of toxicity” must be considered. At this time, available data to dete rmine whether 2

- Propenoic Acid, 2

- Ethylhexyl Ester, Polymer with Ethenylbenzene has common methods of toxicity with other substances is not available. Since it meets the definition of low concern polymer, it is not expected to show any cumulative effects.

E. Safety Determination

1. U.S. population. Based on the conformance to the criteria used to identify a low risk polymer, there is a reasonable certainty of no harm to the US population, including infants and children, from aggregate exposure to residu es of 2

- Propenoic Acid, 2

- Ethylhexyl Ester, Polymer with Ethenylbenzene4