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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, Inert Ingredient Assessment 

Branch (IIAB) 703-308-8811]

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:

[Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, NC 27419-8300]

[2E7986]

EPA has received a pesticide petition ([2E7986]) from [Syngenta Crop 

Protection, LLC], [, P.O. Box 18300, Greensboro, NC 27419-8300] 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.

(Options 2. (pick one)

To establish an exemption from the requirement of a tolerance for

polymers of one or more diglycidyl ethers of bisphenol A, resorcinol, glycerol, 

cyclohexanedimethanol, neopentyl glycol, or polyethylene glycol with one or more of the 

following: polyoxypropylene diamine, polyoxypropylene triamine, n-aminoethylpiperazine , 

trimethyl-1,6-hexanediamine isophorone diamine, N,N-dimethyl-1,3-diaminopropane, nadic 

methyl anhydride, 1,2-cyclohexanedicarboxylic anhydride and 1,2,3,6-tetrahydrophthalic 

anhydride when used as an inert ingredient (carrier) in pesticide formulations under 40 CFR 

180.960 Syngenta is submitting a petition to EPA under the Federal Food Drug and 

Cosemetic Act [FFDCA], as amended by the Food Quality Protection Act of 1996 

[FQPA] requesting an exemption from the requirement of a tolerance. This petition

requests the elimination of the need to establish a maximum permissible level for

residues of polymers of one or more diglycidyl ethers of bisphenol A, resorcinol, glycerol, 

cyclohexanedimethanol, neopentyl glycol, or polyethylene glycol with one or more of the 

following : polyoxypropylene diamine, polyoxypropylene triamine, n-aminoethylpiperazine , 

trimethyl-1,6-hexanediamine isophorone diamine, N,N-dimethyl-1,3-diaminopropane, nadic 

methyl anhydride, 1,2-cyclohexanedicarboxylic anhydride and 1,2,3,6-tetrahydrophthalic 

anhydride 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.

A. Residue Chemistry
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1. Plant metabolism. [NA-Remove based on fact this information is 

generally not required when all criteria for polymer exemption per 40 CFR 723.250 

are met.]

2. Analytical method. [NA-Remove based on fact this information is generally 

not required when all criteria for polymer exemption per 40 CFR 723.250 are met. In

addition, Syngenta is petitioning for an exemption from the requirement of a 

tolerance without any numerical limitations.]]

3. Magnitude of residues. [NA-Remove based on fact this information is 

generally not required when all criteria for polymer exemption per 40 CFR 723.250 

are met.]]]

B. Toxicological Profile

The EPA has established a set of criteria which identify categories of 

polymers that present low risk. These criteria (codified in 40 CFR 723.250) identify

polymers that are relatively unreactive and stable compared to other chemical substances 

as well as polymers that are not readily absorbed. These properties generally limit a 

polymer’s ability to cause adverse effects. No mammalian toxicity is anticipated from 

dietary, inhalation or dermal exposure for chemical substances meeting the requirement 

for polymers of low risk. Syngenta asserts that polymers meeting this polymer exemption

criteria will present minimal or no risk. Therefore, Syngenta believes an exemption from 

the requirement of a tolerance is justified since in the case of low risk polymers it can be

clearly demonstrated that the risks from aggregate exposure to pesticide chemical 

residues under reasonably foreseeable circumstances will poses no appreciable risks to 

human health. Polymers of one or more diglycidyl ethers of bisphenol A, resorcinol, 

glycerol, cyclohexanedimethanol, neopentyl glycol or polyethylene glycol with one or more 

of the following: polyoxypropylene diamine, polyoxypropylene triamine, naminoethylpiperazine , trimethyl-1,6-hexanediamine isophorone diamine, N,N-dimethyl1,3-diaminopropane, nadic methyl anhydride, 1,2-cyclohexanedicarboxylic anhydride and 

1,2,3,6-tetrahydrophthalic anhydride meet the specific criteria per CFR 40 723.250 as 

described below.

• The polymer is not a cationic polymer, nor is it reasonably anticipated to 

become a cationic polymer in a natural aquatic environment.

• The polymer contains as an integral part of its composition the atomic elements 

carbon and hydrogen.

• The polymer does not contain as an integral part of its composition any

elements other than those listed in 40 CFR 723.250.

• The polymer is not designed, nor is reasonably anticipated to substantially

degrade, decompose, or depolymerize.

• The polymer is manufactured only from monomers and or reactants that are

already included on the TSCA Chemical Substance Inventory.

• The polymer is not a water absorbing polymer.

• The polymer does not contain any group as a reactive functional group.
• The polymer has a minimum number average molecular weight of >

10,000 Daltons.

• The polymer contains less than 2% oligomeric material below molecular

weight of 500 Daltons and less than 5% oligomeric material below molecular weight

1,000 Daltons.]

1. Acute toxicity. [N/A – Remove based upon polymer conforming to all criteria 

for low risk polymers under 40 CFR 723.250.]

2. Genotoxicty. [N/A – Remove based upon polymer conforming to all criteria for

low risk polymers under 40 CFR 723.250. ]

3. Reproductive and developmental toxicity. [N/A – Remove based upon polymer 

conforming to all criteria for low risk polymers under 40 CFR 723.250. ]

4. Subchronic toxicity. [N/A – Remove based upon polymer conforming to all 

criteria for low risk polymers under 40 CFR 723.250. .]

5. Chronic toxicity. [N/A – Remove based upon polymer conforming to all 

criteria for low risk polymers under 40 CFR 723.250. 

6. Animal metabolism. [N/A – Remove based upon polymer conforming to all 

criteria for low risk polymers under 40 CFR 723.250. ]

7. Metabolite toxicology. [N/A – Remove based upon polymer conforming to all 

criteria for low risk polymers under 40 CFR 723.250. .]

8. Endocrine disruption. [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 Exposure

1. Dietary exposure. [N/A – Remove based upon conforming to low risk polymer criteria 

identified in 40 CFR 723.250] 

i. Food. [N/A – Remove based upon polymer conforming to low risk polymer

criteria identified in 40 CFR 723.250]

ii. Drinking water. [N/A – Remove based upon polymer conforming to low risk 
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polymer criteria identified in 40 CFR 723.250]]

2. Non-dietary exposure. [N/A – Remove based upon polymer conforming to low 

risk polymer criteria identified in 40 CFR 723.250]

D. Cumulative Effects [N/A – Remove based upon polymer conforming to low risk 

polymer criteria identified in 40 CFR 723.250], 

E. Safety Determination

1. U.S. population. [Based upon the conformation to the criteria used to identify 

low risk polymers, Syngenta believes there is a reasonable certainty of no harm to the US 

population from aggregate exposure to residues of the polymer.]

2. Infants and children. [. Due to the expected low toxicity of the polymer and its 

conformance to all criteria used to identify a low risk polymer, Syngenta believes that a 

safety factor analysis is not required to assess the risk. For the same reasons Syngenta

believes the additional tenfold safety factor is unnecessary.]

F. International Tolerances

[Syngenta is not aware of any country requiring a tolerance for this polymer 

nor have any CODEX Maximum Residue Levels been established for any food 

crops at this time.]