Document ID: EPA-HQ-OPP-2016-0606-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2016-12-20T05:00Z

EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER  

EPA Registration Division contact: Robert Larkin, 2152845702

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.

Tolerance Petition No. XXX

	EPA has received a pesticide petition Tolerance Petition XXX from AgroFresh Inc., 400 Arcola Road, PO Box 7000(RC3356), Collegeville, PA 19426 requesting, 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 (pick one)
   
   	

	to establish an exemption from the requirement of a tolerance for

	polyglycerol polyricinoleic acid (PGPR), CAS No.2984-35-7, with a number average molecular weight of greater than 2000 daltons  in or on all agricultural commodities under 40 CFR 180.960 when used as an emulsifying 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.

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

B. Toxicological Profile

 Acute toxicity.  [NA-Remove based on the fact that PGPR meets all of the criteria that EPA has established to 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 also been demonstrated for PGPR through the conduct of extensive toxicological testing that resulted in the establishment of four GRAS affirmations by FDA between 1999 and 2013.  Therefore AgroFresh believes that establishment of an exemption from the requirements of a tolerance is justified for PGPR.  Further, no aggregate risk to human health is expected due to exposure to residues of PGPR under reasonably foreseeable circumstances of use.  
         
         PGPR meets the definition of a polymer as well as all of the specific criteria under 40 CFR 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 elements carbon, oxygen and hydrogen.
 The polymer does not contain as an integral part of its composition, except as impurities, any elements other than those listed in 40 CFR 723.250(d)(2)(ii).
 The polymer is neither designed nor can it be reasonably anticipated to substantially degrade, decompose or depolymerize.
 The polymer is manufactured or imported from monomers and/or reactants that are already included on the TSCA Chemical Substance Inventory.
 The polymer is not a water absorbing polymer with a number average molecular weight greater than or equal to 10,000 daltons
  The polymer does not contain as an integral part of its composition, except as impurities, any perfluoroalkyl moieties.
 The polymer has a number average molecular weight greater than 1,000 and less than 10,000 daltons.  The polymer contains less than 10% oligomeric material below molecular weight 500 and less than 25% oligomeric material below molecular weight 1,000, and the polymer does not contain any reactive functional groups.   
               

	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.]

	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]

	4. Subchronic toxicity. [NA-Remove based on the fact that this polymer conforms to all criteria as codified in 40 CFR 723.250]

	5. Chronic toxicity. [NA-Remove based on the fact that this polymer conforms to all criteria as codified in 40 CFR 723.250.

	6. Animal metabolism. [NA-Remove based on the fact that this polymer conforms to all criteria as codified in 40 CFR 723.250.]

	7. Metabolite toxicology. [NA-Remove based on the fact that this polymer conforms to all criteria as codified in 40 CFR 723.250.]

	8. Endocrine disruption. [NA-Remove based on the fact that this polymer conforms to all criteria as codified in 40 CFR 723.250.]

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.]

E. Safety Determination

	1. U.S. population. [Based on the conformity of this polymer to the criteria used to identify low risk polymers and on the results of extensive toxicological testing that resulting in four GRAS affirmations for this polymer, 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 and on the results of extensive toxicological testing that resulted in four GRAS affirmations for this polymer, there is a reasonable certainty of no harm to infants and children from aggregate exposure 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 PGPR   In addition, no Codex MRLs have been established for PGPR at this time.]