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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:

AgroFresh Inc., a Rohm and Haas Company

IN-10540

EPA has received a pesticide petition (IN-10540) from AgroFresh Inc., 727 

Norristown Road, Spring House, PA 19477-0904 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

Styrene-ethylene-propylene block copolymer (CAS No. 108388-87-0), number average 

molecular weight greater than 100,000 daltons 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.
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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 a set of 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. This lack of toxicity has been demonstrated for 

polymeric materials similar to styrene-ethylene-propylene block 

copolymer. Therefore AgroFresh believes that establishment of an 

exemption from the requirements of a tolerance is justified for styreneethylene-propylene block copolymer]. Furthermore, no aggregate risk to 

human health is expected due to exposure to residues of styrene-ethylenepropylene block copolymer under reasonably foreseeable circumstances of 
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use. Styrene-ethylene- propylene block copolymer meets the 

definition of a 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.

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.

h. The polymer’s number average MW is greater than 10,000 daltons. The 

polymer contains less than 2% oligomeric material below MW 500 and less 

than 5% 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 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.]
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3. Reproductive and developmental 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 

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 p0lymer

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 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.]

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 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.]

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 through the 

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

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

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 through 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
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[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 with molecular weights greater than 1000 Daltons are generally not 

absorbed through intact skin, nor are they absorbed through the intact 

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

[AgroFresh Inc. is not aware of any country requiring a tolerance for styreneethylene-propylene block copolymer. In addition, no Codex MRLs have been 

established for styrene-ethylene-propylene block copolymer at this time.]