Document ID: EPA-HQ-OPP-2019-0610-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2020-02-11T05:00Z

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

EPA Registration Division contact: [Kerry Leifer, Branch Chief Chemistry, Inerts, Toxicology Assessment Branch (CITAB) 703-308-8811]

TEMPLATE:

[Lamberti USA, Incorporated]

[IN-11339]

	EPA has received a pesticide petition ([IN-11339]) from [Lamberti USA, Incorporated], [P.O. Box 1000, Hungerford TX 77448] 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

This tolerance petition requests to establish an exemption from the requirement of a tolerance for  [the polymer of 2-Propenoic acid, homopolymer, ester with α-methyl-ω-hydroxypoly(oxy-1,2-ethanediyl) and α-[2,4,6-tris(1-phenylethyl)phenyl]-ω-hydroxypoly(oxy-1,2-ethanediyl), graft, sodium salt having a number average molecular weight greater than 1,000 Daltons, used for dispersants, emulsifiers, surfactants and related adjuvants of surfactants] in or on the raw agricultural commodity [growing crops pre or post-harvest or in products to treat animals] at [under 40 CFR 180.960] to include the following Chemical Abstracts Services Registry numbers:

                                     CAS#
                                 CHEMICAL NAME
                                 2221936-17-8
2-Propenoic acid, homopolymer, ester with α-methyl-ω-hydroxypoly(oxy-1,2-ethanediyl) and α-[2,4,6-tris(1-phenylethyl)phenyl]-ω-hydroxypoly(oxy-1,2-ethanediyl), graft, sodium salt

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

[Waived under the polymer exemption definition.]

	1. Analytical method. [An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation.]

	2. Magnitude of residues. [Waived under the polymer exemption definition.]

B. Toxicological Profile

Lamberti USA, Incorporated has reviewed the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk.  Lamberti USA, Incorporated has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children for the low risk polymer classification.

	1. Acute toxicity.  [Waived under the polymer exemption definition.]

	2. Genotoxicty. [Waived under the polymer exemption definition.]

	3. Reproductive and developmental toxicity. [Waived under the polymer exemption definition.]

	4. Subchronic toxicity. [Waived under the polymer exemption definition.]

	5. Chronic toxicity. [There is no evidence that 2-Propenoic acid, homopolymer, ester with α-methyl-ω-hydroxypoly(oxy-1,2-ethanediyl) and α-[2,4,6-tris(1-phenylethyl)phenyl]-ω-hydroxypoly(oxy-1,2-ethanediyl), graft, sodium salt is carcinogenic.]

	6. Endocrine disruption. [FQPA requires EPA to develop a screening program to determine whether certain substances, including all pesticide chemicals (both inert and active ingredients), "may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or such other endocrine effect..."  EPA has been working with interested stakeholders to develop a screening and testing program as well as a priority setting scheme.  As the Agency proceeds with implementation of the program, further testing of products containing the polymer of 2-Propenoic acid, homopolymer, ester with α-methyl-ω-hydroxypoly(oxy-1,2-ethanediyl) and α-[2,4,6-tris(1-phenylethyl)phenyl]-ω-hydroxypoly(oxy-1,2-ethanediyl), graft, sodium salt for endocrine effects may be required.  This class of chemistry does not belong to a class of chemicals known or suspected of having adverse effects on the estrogen receptor or endocrine system.]
	
      7. Low Risk Polymer. [Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability and the relationship of this information to human risk, EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers 
      
      In the case of certain chemical substances that are defined as polymers, the Agency has established a set of criteria to identify categories of polymers expected to present minimal or no risk.  The definition of a polymer is given in 40 CFR 723.250(b) and the exclusion criteria for identifying these low-risk polymers are described in 40 CFR 723.250(d).  2-Propenoic acid, homopolymer, ester with α-methyl-ω-hydroxypoly(oxy-1,2-ethanediyl) and α-[2,4,6-tris(1-phenylethyl)phenyl]-ω-hydroxypoly(oxy-1,2-ethanediyl), graft, sodium salt conforms to the definition of a polymer given in 40 CFR 723.250(b) and meets the following criteria that are used to identify low-risk polymers.
      
 The polymer is not a cationic polymer not it is reasonably anticipated to become a cationic polymer in a natural aquatic environment.
 The polymer does contain as an integral part of its composition the atomic elements carbon, hydrogen, and oxygen.
 The polymer does not contain as an integral part of its composition, except as impurities, any element 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 or manufactured in an applicable TSCA section 5 exemption.  
 The polymer is not a water absorbing polymer with a number average molecular weight (MW) greater than or equal to 10,000 daltons.
 The polymer does not contain certain perflouoroalkyl moieties consisting of a CF3- or longer chain length as specified in 40 CFR 723.250(d)(6).  
         
Additionally, the polymer also meets as required the following exemption credited specified in 40 CFR 723.250(e).  
 The polymer's minimum number average MW is greater than or equal to 1,000 daltons.  The polymer contains less than 2% oligomeric material below MW 500 and less than 5% oligomeric material below MW 1000.  

Thus 2-Propenoic acid, homopolymer, ester with α-methyl-ω-hydroxypoly(oxy-1,2-ethanediyl) and α-[2,4,6-tris(1-phenylethyl)phenyl]-ω-hydroxypoly(oxy-1,2-ethanediyl), graft, sodium salt meets the criteria for a polymer to be considered low risk under 40 CFR 723.250.  Based on its conformance to the criteria in this unit, no mammalian toxicity is anticipated from dietary, inhalation, or dermal exposure to 2-Propenoic acid, homopolymer, ester with α-methyl-ω-hydroxypoly(oxy-1,2-ethanediyl) and α-[2,4,6-tris(1-phenylethyl)phenyl]-ω-hydroxypoly(oxy-1,2-ethanediyl), graft, sodium salt.]

C. Aggregate Exposure

	1. Dietary exposure. [In examining aggregate exposure, section 408 of the FFDCA directs EPA to consider available information concerning exposures from the pesticide residue in food and all other non-occupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses).

	EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health.  In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings.  If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.

	The polymer of 2-Propenoic acid, homopolymer, ester with α-methyl-ω-hydroxypoly(oxy-1,2-ethanediyl) and α-[2,4,6-tris(1-phenylethyl)phenyl]-ω-hydroxypoly(oxy-1,2-ethanediyl), graft, sodium salt proposed use as an inert ingredients in pesticide products that are currently registered for uses that could result in intermediate-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with intermediate-term residential exposures to the polymer 2-Propenoic acid, homopolymer, ester with α-methyl-ω-hydroxypoly(oxy-1,2-ethanediyl) and α-[2,4,6-tris(1-phenylethyl)phenyl]-ω-hydroxypoly(oxy-1,2-ethanediyl), graft, sodium salt.]

D. Cumulative Effects

	[Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of safety finding as to the polymer of 2-Propenoic acid, homopolymer, ester with α-methyl-ω-hydroxypoly(oxy-1,2-ethanediyl) and α-[2,4,6-tris(1-phenylethyl)phenyl]-ω-hydroxypoly(oxy-1,2-ethanediyl), graft, sodium salt.]

E. Safety Determination

	1. U.S. population. [Based on these risk assessments, Lamberti USA, Incorporated concludes that there is a reasonable certainty that no harm will result to the general population or to infants and children from aggregate exposure to residues of the polymer 2-Propenoic acid, homopolymer, ester with α-methyl-ω-hydroxypoly(oxy-1,2-ethanediyl) and α-[2,4,6-tris(1-phenylethyl)phenyl]-ω-hydroxypoly(oxy-1,2-ethanediyl), graft, sodium salt.  ]

	2. Infants and children. [Based on these risk assessments, Lamberti USA, Incorporated concludes that there is a reasonable certainty that no harm will result to the general population or to infants and children from aggregate exposure to the residues of the polymer 2-Propenoic acid, homopolymer, ester with α-methyl-ω-hydroxypoly(oxy-1,2-ethanediyl) and α-[2,4,6-tris(1-phenylethyl)phenyl]-ω-hydroxypoly(oxy-1,2-ethanediyl), graft, sodium salt.]

F. International Tolerances

	[Lamberti USA, Incorporated is not aware of any country requiring a tolerance for the polymer of 2-Propenoic acid, homopolymer, ester with α-methyl-ω-hydroxypoly(oxy-1,2-ethanediyl) and α-[2,4,6-tris(1-phenylethyl)phenyl]-ω-hydroxypoly(oxy-1,2-ethanediyl), graft, sodium salt nor have any CODEX Maximum Residue Levels been established for any food crops at this time.]