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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:**
**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 commodit ies under 40 CFR 180.960 when used as a suspe nsion 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 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 t he 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 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**  **stabl e 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 a**  **nd 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**  **- f** **urandione, 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. 25**  **0 as described below:** 

a. **The polymer**  **is not a cationic p**  **o lymer, 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 li sted 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 pol**  **ymer 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 m aterial below MW**  **500 and less than 2**  **% 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**  **from the**  **gastrointestinal tract**  **. Chemicals not absorbed through the skin or through the gastroi**  **ntestinal 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. 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 gastr** **ointestinal tract are generally not capable of producing a toxic response.**  **]**

4. Subchronic toxicity. **[ NA** **- REMOVE**  **based on the fact that this p**  **o 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 from**  **the gastrointestinal tract. Chemicals not absorbed through the skin**  **or through the gastroi**  **ntestinal 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.**  **2 50. In**  **particular, substanc es 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 cri teria 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**  **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 r isk 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**  **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 .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 ga**  **strointestinal 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 p**  **olymer 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 ex** **emptions 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 s**  **kin 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**  **u sed 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. ]**