September 17, 2015

Notice of Filing

EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE 

PETITIONS PUBLISHED IN THE FEDERAL REGISTER 

EPA Registration Division contact: Dr. P.V. Shah, 703-308-1846

INSTRUCTIONS: Please utilize this outline in preparing the pesticide 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:

Michelman, Inc.

[Insert petition number]

EPA has received a pesticide petition ([insert petition number]) from Michelman, 9080 Shell 

Road, Cincinnati, OH, 45236 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. to establish an exemption from 

the requirement of a tolerance for Ethylene Acrylic Acid Copolymer, minimum number average 

molecular weight (in amu), 5619; CAS Reg. No. 9010-77-9 for use as a pesticide inert 

ingredient under 40 CFR 180.960 as a coating for seeds to prevent dust off and improve flow 

through a planter in or on all raw agricultural commodities. 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.
Notice of Filing

Sept 17, 2015

A. Residue Chemistry

1. Plant metabolism. NA- Remove – based on the fact that this information is generally 

not required for the establishment of a tolerance exemption

2. Analytical method. NA- Remove – based on the fact that this information is 

generally not required for the establishment of a tolerance exemption

3. Magnitude of residues. NA – remove. The petition proposes to establish exemption 

from the requirement of a tolerance and no analytical method is generally required for 

establishment of a tolerance exemption

B. Toxicological Profile

1. Acute toxicity. Ethylene Acrylic Acid Copolymer conforms to the definition of a 

polymer given in 40 CFR 723.250(b) and meets the following 40 CFR 723.250 criteria that 

are used to identify low-risk polymers.

1. The polymer is not cationic nor is it reasonably anticipate to become a cationic 

polymer in a natural aquatic environment

2. The polymer contains carbon and hydrogen as an integral part of its composition 

3. The polymer 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) including, 

inter alia, the monatomic counter ions Na+, Mg+2, Al+3, K+, Ca+2, Cl-

, Br-, or I. 

4. The polymer is neither designed nor can it be reasonably anticipate to substantially 

degrade, decompose or depolymerize

5. The polymer is manufactured or imported from monomers and/or reactants that are 

already included on the TSCA Chemical Substance Inventory including Acrylic acit 

CAS 79-10-7 and ethylene CAS 74-85-1. 

6. The polymer is not a water-absorbing polymer with a number average molecular 

weight greater than or equal to 10,000 daltons
Notice of Filing

Sept 17, 2015

7. The polymer does not contain, as an integral part of its composition, except as 

impurities, any of the following perfluoroalkyl moieties consisting of a CF3- or longer 

chain length: (1) Perfluoroalkyl sulfonates (PFAS), (2) Perfluoroalkyl carboxyalates 

(PFAC), (3)Fluorotelomers, and (4) Perfluoroalkyl moieties that are covalently bound 

to either a carbon or sulfur atom where the carbon or sulfur atom is an integral part 

of the polymer molecule. 

Additionally, the Polymer mees meets the following exemption criteria specified in 40 

CFR 723.250(e)(1). The polymer’s number average MW of 5619 is greater than 1,000 and 

less than 10,000 daltons. The polymer contains less than 10% oligomeric material below MW 

500 and less than 25% oligomeric material below MW 1,000. This polymer does not contain 

any reactive functional groups. 

2. Genotoxicty. NA-Remove based on the fact that this polymer meets the 40 CRF 

723.250 criteria that are used to identify low-risk polymers. 

3. Reproductive and developmental toxicity. NA-Remove based on the fact that this 

polymer meets the 40 CRF 723.250 criteria that are used to identify low-risk polymers.

4. Subchronic toxicity. NA-Remove based on the fact that this polymer meets the 40 

CRF 723.250 criteria that are used to identify low-risk polymers.

5. Chronic toxicity. NA-Remove based on the fact that this polymer meets the 40 CRF 

723.250 criteria that are used to identify low-risk polymers.

6. Animal metabolism. NA-Remove based on the fact that this polymer meets the 40 

CRF 723.250 criteria that are used to identify low-risk polymers.

7. Metabolite toxicology. NA-Remove based on the fact that this polymer meets the 40 

CRF 723.250 criteria that are used to identify low-risk polymers.

8. Endocrine disruption. NA-Remove based on the fact that this polymer meets the 40 

CRF 723.250 criteria that are used to identify low-risk polymers.
Notice of Filing

Sept 17, 2015

C. Aggregate Exposure

1. Dietary exposure. NA-Remove based on the fact that this polymer meets the 40 CRF 

723.250 criteria that are used to identify low-risk polymers.

i. Food. NA-Remove based on the fact that this polymer meets the 40 CRF 723.250 

criteria that are used to identify low-risk polymers.

ii. Drinking water. NA-Remove based on the fact that this polymer meets the 40 CRF 

723.250 criteria that are used to identify low-risk polymers.

2. Non-dietary exposure. NA-Remove based on the fact that this polymer meets the 40 

CRF 723.250 criteria that are used to identify low-risk polymers.

D. Cumulative Effects

NA-Remove based on the fact that this polymer meets the 40 CRF 723.250 criteria 

that are used to identify low-risk polymers.

E. Safety Determination

1. U.S. population. NA-Remove based on the fact that this polymer meets the 40 CRF 

723.250 criteria that are used to identify low-risk polymers.Insert text.]

2. Infants and children. NA-Remove based on the fact that this polymer meets the 40 

CRF 723.250 criteria that are used to identify low-risk polymers.

F. International Tolerances
Notice of Filing

Sept 17, 2015

NA-Remove based on the fact that this polymer meets the 40 CRF 723.250 criteria 

that are used to identify low-risk polymers.

Sincerely,

Charles G. Lewis

Regional Regulatory Affairs Mgr, Americas

Michelman, Inc.