### EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR

PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: PV Shah, Branch Chief; 703

- 308

- 1846

INSTRUCTIONS: Please utilize this outline in preparing the pest icide 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:

[Itaconix Corporation]

[ IN

- 10818 ]

EPA has received a pesticide petition ( IN

- 10818 ) from [Itaconix Corporation] , [2 Marin Way, Stratham, NH 03885] proposing, pur suant 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

[Butanedioic acid, 2

- methylene

- , h omopolymer, sodium salt, 4000 amu, CAS # 26099

- 89

- 8] in or on the raw agricultural commodity [under 40 CFR 180.960 when used as an inert ingredient in pesticides as a water conditioner for chelating calcium and magnesium so that pesticides can be used at a lower concentration in formulation and during application] at 1,000

- 10,000 parts per million (ppm). 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 f ully 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.

2. Analytical meth od. [NA

- Remove]

3. Magnitude of residues. [NA

- Remove]2



### B. Toxicological Profile

1. Acute toxicity. LD50>2000 mg/Kg

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]

This polymer meets all the criteria listed in 40 CFR 723.250 to qualify as a low risk polymer as described below.



### Meets the criteria for definition of a polymer under section 40 CFR 723.250 (b). Butanedioic acid, 2

- methylene

- , homopolymer, sodium salt is a polymer of sodium itaconate with a degree of polymerization of ~26 all covalently bonded. Mo lecular weight distribution dispersity is illustrated in GPC Slice Data with Mw/Mn=9995/3936=2.54. Proposed polymer meets the criteria for definition of a polymer under section (b).



### Meets the criteria for low risk polymer under 40 CFR 723.250 (d). Polyme r not a cationic polymer nor is it reasonably anticipated to become a cationic polymer in a natural aquatic environment. Butanedioic acid, 2

- methylene

- , homopolymer, sodium salt is an anionic polymer. Polymer contains as an integral part of its compositi on at least two of the elements carbon, hydrogen, nitrogen, oxygen, silicon, and sulfur. Butanedioic acid, 2

- methylene

- , homopolymer, sodium salt contains carbon, hydrogen, oxygen and sulfur. Polymer does not contain as an integral part of its compositio n, except as impurities, any elements other than those listed in 40 CFR 723.250 (d)(2)(ii). Butanedioic acid, 2

- methylene

- , homopolymer, sodium salt contains carbon, hydrogen, oxygen, sulfur and sodium. Polymer is not designed to substantially degrade, d ecompose, or depolymerize. Butanedioic acid,
2

- methylene

- , homopolymer, sodium salt is based on a carbon

- carbon backbone made by free

- radical polymerization of a vinyl bond. These polymeric structures are notoriously stable under normal use conditions foun d in agriculture. Polymer is not anticipated to substantially degrade, decompose, or depolymerize. Carbon

- carbon polymer backbones such as the one present in Butanedioic acid, 2

- methylene

- , homopolymer, sodium salt do not biodegrade at short time scale b y either oxidation, hydrolysis, attack by solvents, heat, light or microbial action conditions encountered in commonly practiced agriculture. Polymer is manufactured from monomer and reactants already listed on TSCA Chemical Substance Inventory. The mono mers and reactants used to manufacture Butanedioic acid, 2

-3

methylene

- , homopolymer, sodium salt are all listed on TSCA Chemical Substance Inventory. Polymer is not a water

- absorbing polymer with average molecular weight greater than 10,000 daltons. Butane dioic acid, 2

- methylene

- , homopolymer, sodium salt number average molecular weight is 3.936 x 10 3 grams/mole. Polymer does not contain, as an integral part of its composition, except as impurities, one or more perfluoroalkyl moieties. Butanedioic acid, 2

- methylene

- , homopolymer, sodium salt composition does not contain fluorine.



### Meets the criteria for low risk polymer under 40 CFR 723.250 (e). (i) Polymer meets the exception criteria listed in 40 CFR 723.250 (e) Option 1 as number average MW greater than 1000 and less than 10,000 daltons (and oligomer content less than 10% below MW 500 and less than 25% below MW 1000).

 Average molecular weight = 3926 grams/mole

 Wt % Oligomer < 1000 MW= 3.53%

 Wt % Oligomer < 500 MW= 0.37% (ii) Polymer does not contain any reactive functional groups except carboxylic acid, which is acceptable under 40 CFR 723.250 (e)(1)(ii)(A).



### C. Aggregate Exposure

1. Dietary exposure. [NA

- Remove]

i. Food. [NA

- Remove]

ii. Drinking water. [NA

- Remove]

2. Non

- dietary exposur e

. [NA

- Remove]

D. Cumulative Effects

[NA

- Remove]

E. Safety Determination

1. U.S. population. [NA

- Remove]

2. Infants and children

. [NA

- Remove]

F. International Tolerances

[NA

- Remove]