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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 re place 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 **St yrene**  **- ethylene**  **- propylene block copolymer**  **( CAS No.**  **108388 -** **87 -** **0 )** **, number average mo**  **lecular weight greater than 100 ,000 daltons**  in or on all raw agricultural commodit ies under 40 CFR 180.960 when used as a suspension agent in agri cultural 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 d a ta at this time or whether the data supports grantin g 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 wh**  **e n**  **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 absorbe d 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 exe mption 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 f or**  **styrene**   ** ethylene** **- propylene block copolymer** **] . Furthermore, no aggregate risk to**  **human health is expected due to exposure to residues of styrene**  **- ethylene**  **** **propylene block copolymer under reasonably**  **foreseeable circumstances of** 3 **use. Styrene**  **- ethylene**  **- propy**  **lene block copolymer meets**  **the definition of a polymer as well as all of the**  **specific criteria under 40 CFR**  **723. 25**  **0 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 in tegral 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 include**  **d 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% oligo meric material below MW 500 and less**  **than 5% oligomeric material below MW 1000.**

2. Genotoxicty. **[ NA** **- REMOVE**  **b ased on the fact that this**  **po lymer**  **conforms to all criteria for low risk polymers as codified in 40 CFR 723.**  **2 50. 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 genera**  **lly not capable of producing a toxic response.**  **]**4 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. 2**  **50. 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 genera lly 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. 2**  **50. 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 produc ing 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.**  **2 50. 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 respon se.**  **]**

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. 2**  **50. 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. 2**  **50. In particular, substances with molecular weights greater than 1000 Daltons generally**  **are not a bsorbed through intact skin, nor are they generally absorbed through the** 5

**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 .2**  **50. 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 endo crine 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 Effects6 **[ 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 confor**  **mity 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 mor e susceptible**  **to adverse effects from**  **exposure to this polymer** **]**
F. International Tolerances **[ AgroFresh Inc. is not aware of any country requiring a tolerance for**  **styrene**   ** ethylene** **- propylene block copolymer**  **. In addition, no Codex MRLs have been establish**  **ed for styrene**  **- ethylene**  **- propylene block copolymer**  **at this time. ]**