i

EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS 

PUBLISHED IN THE FEDERAL REGISTER 

EPA Registration Division contact: 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:

Specialty Fertilizer Products LLC

IN-10697

EPA has received a pesticide petition, IN-10697 (from Specialty Fertilizer 

Products LLC, 11550 Ash Street, Suite 220, Leawood KS 66211) 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 180.960 to establish an exemption from the requirement of a 

tolerance for butanedioic acid, 2-methylene-, polymer with 2,5-furandione, sodium and 

ammonium salts, hydrogen peroxide-initiated (CAS Reg. No. 556055-76-6 and 701908-99-8) in 

or on all raw agricultural commodities under 40 CFR 180.960 when used as a suspension 

agent in agricultural formulations. 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.
2

A. Residue Chemistry

1. Plant metabolism. [NA-REMOVE based on the fact that 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 the fact that this information is

generally not required when all criteria for polymer exemption are met and when 

petitioning for an exemption from the requirements of a tolerance without any 

numerical limitations.]

3. Magnitude of residues. [NA-REMOVE based on the fact that this information 

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

are met.]

B. Toxicological Profile

1. Acute toxicity. [EPA has established criteria which identify categories of 

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

identify polymers with properties that make them relatively unreactive and 

stable as well as not readily absorbed as compared to other chemical 

substances. These properties generally limit a polymer’s ability to cause 

adverse toxicological effects. No mammalian toxicity is anticipated from 

dietary, inhalation or dermal exposure for polymers meeting the polymer 

exemption criteria. Therefore Specialty Fertilizer Products believes that 

establishment of an exemption from the requirements of a tolerance is 

justified for butanedioic acid, 2-methylene-, polymer with 2,5-furandione, 

sodium and ammonium salts, hydrogen peroxide-initiated. Furthermore, no 

aggregate risk to human health is expected due to exposure to residues of 

this copolymer under reasonably foreseeable circumstances of use. 

Butanedioic acid, 2-methylene-, polymer with 2,5-furandione, sodium and 

ammonium salts, hydrogen peroxide-initiated meets the definition of a 
3

polymer as well as all of the specific criteria under 40 CFR 723.250 as 

described below:

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

become a cationic polymer in a natural aquatic environment.

b. The polymer contains as an integral part of its composition the elements 

carbon and hydrogen. 

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

elements other than those listed in 40 CFR 723.250.

d. The polymer is not expected to substantially degrade, decompose or 

depolymerize during use.

e. The polymer is manufactured only from monomers and/or reactants that 

are already included on the TSCA Chemical Substances Inventory.

f. The polymer is not a water absorbing polymer.

g. The polymer does not contain any reactive functional groups that can be 

ionized to a cation.

h. The polymer’s number average MW is greater than 2,500 daltons. The 

polymer contains substantially less than 2% oligomeric material below MW 

500 and less than 2% oligomeric material below MW 1000.

2. Genotoxicty. [NA-REMOVE based on the fact that this polymer conforms to 

all criteria for low risk polymers as codified in 40 CFR 723.250. In particular, 

substances with molecular weights greater than 1000 Daltons generally are 

not absorbed through intact skin, nor are they generally absorbed from the 

gastrointestinal tract. Chemicals not absorbed through the skin or through 

the gastrointestinal tract are generally not capable of producing a toxic 

response.]

3. Reproductive and developmental toxicity. [NA-REMOVE based on the fact 

that this polymer conforms to all criteria for low risk polymers as codified 
4

in 40 CFR 723.250. In particular, substances with molecular 

weights greater than 1000 Daltons generally are not absorbed through 

intact skin, nor are they generally absorbed through the intact 

gastrointestinal tract. Chemicals not absorbed through the skin or through 

the gastrointestinal tract are generally not capable of producing a toxic 

response.]

4. Subchronic toxicity. [NA-REMOVE based on the fact that this polymer

conforms to all criteria for low risk polymers as codified in 40 CFR 723.250. In 

particular, substances with molecular weights greater than 1000 Daltons generally are 

not absorbed through intact skin, nor are they generally absorbed from the

gastrointestinal tract. Chemicals not absorbed through the skin or through the 

gastrointestinal tract are generally not capable of producing a toxic response.]

5. Chronic toxicity. [NA-REMOVE based on the fact that this polymer conforms 

to all criteria for low risk polymer exemptions as codified in 40 CFR 723.250. In 

particular, substances with molecular weights greater than 1000 Daltons generally are 

not absorbed through intact skin, nor are they generally absorbed from the 

gastrointestinal tract. Chemicals not absorbed through the skin or through the 

gastrointestinal tract are generally not capable of producing a toxic response.]

6. Animal metabolism. [NA-REMOVE based on the fact that this polymer

conforms to all criteria for low risk polymer exemptions as codified in 40 CFR 723.250. 

In particular, substances with molecular weights greater than 1000 Daltons generally 

are not absorbed through intact skin, nor are they generally absorbed from the 

gastrointestinal tract. An animal metabolism study would therefore not be relevant 

for a material that does not absorb through the skin or the gastrointestinal tract.]

7. Metabolite toxicology. [NA-REMOVE based on the fact that this polymer

conforms to all criteria for low risk polymer exemptions as codified in 40 CFR 723.250. 

In particular, substances with molecular weights greater than 1000 Daltons generally 

are not absorbed through intact skin, nor are they generally absorbed from the 

gastrointestinal tract. Chemicals not absorbed through the skin or through the 

gastrointestinal tract are generally not capable of producing a toxic response.]
5

8. Endocrine disruption. [NA-REMOVE based on the fact that this polymer

conforms to all criteria for low risk polymer exemptions as codified in 40 CFR 723.250. 

In particular, substances with molecular weights greater than 1000 Daltons generally 

are not absorbed through intact skin, nor are they absorbed through the intact 

gastrointestinal tract. Chemicals not absorbed through the skin or from the 

gastrointestinal tract are generally not capable of producing a toxic response, 

including toxicity related to endocrine disruption.]

C. Aggregate Exposure

1. Dietary exposure. [NA-REMOVE based on the fact that this information is 

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

met.]

i. Food. [NA-REMOVE based on the fact that this information is generally not 

required when all criteria for polymer exemption per 40 CFR 723.250 are met.]

ii. Drinking water. [NA-REMOVE based on the fact that this information is 

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

met.]

2. Non-dietary exposure. [NA-REMOVE based on the fact that this information is 

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

met.]

D. Cumulative Effects

[NA-REMOVE based on the fact that this polymer conforms to all criteria for 

low risk polymer exemptions as codified in 40 CFR 173.250. In particular, substances 
6

with molecular weights greater than 1000 Daltons are generally not absorbed 

through intact skin, nor are they absorbed from the gastrointestinal tract. Chemicals 

not absorbed through the skin or through the intestinal tract are generally not capable 

of producing a toxic response.]

E. Safety Determination

1. U.S. population. [Based on the conformity of this polymer to the criteria used 

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

population from aggregate exposure to residues of this polymer.]

2. Infants and children. [Based on the conformity of this polymer to the criteria 

used to identify low risk polymers, there is a reasonable uncertainty of no harm to 

infants and children from aggregate exposures of this polymer. In addition, there is no 

evidence to indicate that infants and children would be more susceptible to adverse 

effects from exposure to this polymer]

F. International Tolerances

[Specialty Fertilizer Products is not aware of any country requiring a tolerance 

for copolymer. In addition, no Codex MRLs have been established for copolymer at 

this time.]