# i

EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER EPA Registration Division contact: William Cutchin, 703 - 305 - 7990 INSTRUCTIONS: Please utilize this outline in prep aring 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: Lamberti USA, Inc . I N - 10 83 6 EPA has received a pesticide petition ( IN - 10 83 6 ) from Spring Trading Company, 203 Dogwood Trail, Magnolia, Texas 77354

- 5201 on behalf of Lam berti USA, Inc., 14622 Exxon Road, Conroe, Texas 77302 , 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 to establish an exemption from the re quirement of a tolerance for the polymer 2 - propenoic acid homopolymer, reaction products with Poly( oxy - 1,2 - ethanediyl), a - (tris(l - phenylethyl)phenyl) - w - hydroxy, Tris(2 - Hydroxyethyl)Amine salt) having an average molecular weight of greater than 10,000 Daltons, used for d ispersants, emulsifiers, surfactants and related adjuvants of surfactants (CAS# 1477613

- 46

- 9) under 40 CFR 180.9 6 0 when used growing crops pre or postharvest or in products to treat animals
. EPA has determined that the petition contains data or informatio n 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 rule s 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 Profile2
Lamberti USA, Inc. 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, Inc. has also considered available information concerning the variabilit y of the sensitivities of major identifiable subgroups of consumers, including infants and child ren for the low risk polymer classification. These polymers are not acutely toxic by the oral and dermal routes of exposure, or via inhalation under normal use conditions. Concentrated materials are generally not corrosive, eye and skin irritants and not d ermal sensitizers. There is no evidence that these polymers are neurotoxic, mutagenic, or clastogenic. Specific information on the studies evaluated and the nature of the adverse effects findings by the agency for the polymers as well as the no

- observed

- adverse

- effect level (NOAEL) and the lowest

- observed

- adverse

- effect

- level (LOAEL) from the toxicit y studies can be found at http://www.regulations.gov in documents allowing the approval of defined low risk polymeric compounds. 1. Acute toxicity
. Waived under the polymer exemption definition. 2. Genotoxicty. Waived under the polymer exemption defini tion. 3. Reproductive and developmental toxicity
. Waived under the polymer exemption definition. 4. Subchronic toxicity. Waived under the polymer exempti on definition. 5. Chronic toxicity. T here is no evidence that 2

- propenoic acid homopolymer, reaction products with Poly(oxy

- l,2

- ethanediyl), a

- (tris(l

- phenylethyl)phenyl)

- w - hydroxy, Tris(2

- Hydroxyethyl)Amine salt) are carcinogenic. 6. Endocrine disrupt ion. 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 occurri ng estrogen, or such other endocrine effect. .EPA has been working with interested stakeholders to develop a screening and testing program as well as a priorit y setting scheme. As the Agency proceeds with implementation of this program, further testing of products containing the polymers of 2

- propenoic acid homopolymer, reaction products with PoIy(oxy

- l,2

- ethanediyl), a - |tris(l

- phenylethyl)phenyl)

- w - hydroxy, Tris(2

- Hydroxyethyl)Amine 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
. C. Aggregate Exposure 1. Dietary exposure
. In examining aggregate exposure, section 408 of the FFDCA directs EPA to consider a vailable information concerning exposures from the pesticide residue in food and all other non

- occupational exposures, including drinking water from3 ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residenti al 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 wi ll 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 ill 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 polymers of 2

- propenoic acid homopolymer, reaction products with Poly(oxy

- l,2

- ethanediyl),a

- [tris(l

- phenylethyl)phenyl)

- w - hy droxy,Tris(2

- Hydroxyethyl)Amine salt) proposed use as 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 aggrega te c hronic exposure through food and water with intermediate

- term residential exposures to the polymers of 2

- propenoic acid homopolymer, r eaction products with Poly(oxy

- 1, 2

- ethanediyl), a

- |tris(l

- phenylethyl)phenyl)

- w - hydroxy, Tris(2

- Hydroxyethyl)Ami ne sal t). 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 safet y finding as to polymers of 2

- propenoic acid homopolymer, rea ction products with Poly(oxy

- l,2

- ethaned iyl), a

- ( tris(l

- phenylet h yl)phenyl)

- w - hydroxy, Tris(2

- Hydroxyethyl)Amine salt) with and any other substances. E. Safety Determination 1. U.S. population. Based on these risk assessments, Lamberti USA, Inc. conclu des 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 polymers of 2

- propenoic acid homopolymer, reaction products with Poly(oxy

- l,2

- ethanediyl), a

- (tris (l

- phenylethyl)phenyl)

- w - hydroxy, Tris(2

- Hydroxyethyl)Amine salt). 2. Infants and children
. Based on these risk assessments, Lamberti USA, Inc. concludes that there is a reasonable certainty that no harm will result to the general population or to i nfants and children from aggregate exposure to residues of polymers of 2

- propenoic acid homopolymer, reaction products with Poly(oxy

- l,2

- ethanediyl), a - (tris(l

- phe nylethyl)phenyl)

- w - hydroxy, Tris(2

- Hydroxyethyl)Amine salt). F. International Tolerances4

Lamberti USA, Inc. is not aware of any country requiring a tolerance for the polymers of 2

- propenoic acid homopolymer, reaction products with Poly(oxy

- l,2

- ethanediyl), a

- (tris( l

- phenylethyl)phenyl)

- w - hydroxy, Tris(2

- Hydroxyethyl)Amine salt) nor have an y CODEX Maximum Residue Levels been established for any food crops at this time.