Document ID: EPA-HQ-OPP-2016-0283-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2016-07-20T04:00Z

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

EPA Registration Division contact: Mark Dow  (703) 305-5533

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:

OMC Ag Consulting

 

IN-10935

	EPA has received a pesticide petition (IN-10935) from OMC Ag Consulting
(828 Tanglewood Lane, East Lansing, MI 48823) on behalf of  Vive Crop
Protection, Inc. (700 Bay Street, Suite 1100, Toronto, Ontario, Canada,
M5G-1Z6) 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  to establish an exemption from the requirement of a tolerance for
acrylic polymers (CAS Reg. No.2156-97-0) and acrylamidopropyl (CAS Reg.
No. 15214-89-8) when used in pesticide formulations applied to growing
crops under 40 CFR 180.960. 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 to revise an existing exemption from the
requirement of a tolerance for modified acrylic polymers located in 40
CFR part 180.960

The existing tolerance exemption reads as follows: Acrylic polymers
composed of one or more of the following monomers: Acrylic acid, methyl
acrylate, ethyl acrylate, butyl acrylate, hydroxyethyl acrylate,
hydroxypropyl acrylate, hydroxybutyl acrylate, carboxyethyl acrylate,
methacrylic acid, methyl methacrylate, ethyl methacrylate, butyl
methacrylate, isobutyl methacrylate, hydroxyethyl methacrylate,
hydroxypropyl methacrylate, hydroxybutyl methacrylate, lauryl
methacrylate, and stearyl methacrylate; with none and/or one or more of
the following monomers: Acrylamide, N-methyl acrylamide, N,N-dimethyl
acrylamide, N-octylacrylamide, maleic anhydride, maleic acid, monoethyl
maleate, diethyl maleate, monooctyl maleate, dioctyl maleate; and their
corresponding sodium, potassium, ammonium, isopropylamine,
triethylamine, monoethanolamine, and/or triethanolamine salts; the
resulting polymer having a minimum number average molecular weight (in
amu), 1,200.  No CAS registry number is associated with the exemption.

Vive Crop Protection, Inc. is requesting that the exemption be revised
to include lauryl acrylate by inserting lauryl acrylate between
hydroxybutyl methacrylate and lauryl methacrylate, and by inserting
acrylamidopropyl methyl sulfonic acid after dioctyl maleate.

A. Residue Chemistry

	1. Plant metabolism. NA-Remove

	2. Analytical method. NA-Remove

	3. Magnitude of residues. Vive Crop Protection, Inc. is petitioning for
an exemption from the requirement of a tolerance based upon the
polymer’s compliance with the Low Risk Polymer criteria per 40 CFR
723.250.  Therefore, an analytical method to determine residues in raw
agricultural commodities has not been proposed.  No residue chemistry
data or environmental fate data are presented in the petition as the
Agency does not generally requires some or all of the listed studies to
rule on the exemption from the requirement of a tolerance for a low risk
polymer inert ingredient.

B. Toxicological Profile

1. Acute toxicity.

The Agency has established a set of criteria which identifies categories
of polymers that present low risk.  These criterial (described in 40 CFR
723.250) identify polymers that are relatively unreactive and stable
compared to other chemical substances, as well as, polymers that
typically are not readily absorbed.  Vive Crop Protection, Inc.,
believes that lauryl acrylate polymers and acrylamidopropyl methyl
sulfonic acid polymers conform to the definition of a polymer given in
40 CFR 723.250 and meets the criteria used to identify a low risk
polymer.  Vive Crop Protection, Inc., also believes that based on these
substances conformance to the above mentioned criteria, no mammalian
toxicity is anticipated from dietary, inhalation or dermal exposure to
polymers and that these polymers will present minimal or no risk.

1. These polymers are not cationic polymers.

2. They contain as an integral part of their composition the atomic
elements carbon, hydrogen, and oxygen.

3. They do not contain as an integral part of their composition, except
as impurities, any elements other than those listed in   HYPERLINK
"https://www.federalregister.gov/select-citation/2001/06/20/40-CFR-723.2
50"  40 CFR 723.250 (d)(2)(ii).

4. These polymers are not designed or reasonably anticipated to
substantially degrade, decompose, or depolymerize.

5. These polymers are not manufactured or imported from monomers and/or
other reactants that are not already on the TSCA Chemical Substance
Inventory or manufactured under an applicable TSCA section 5 exemption.

6. They are not water absorbing polymers.

7. The minimum average molecular weight of the above-mentioned polymers
is greater than 1,000. Substances with molecular weights greater than
400 are generally not readily absorbed through the intact skin, and
substances with molecular weights greater than 1,000 are generally not
absorbed through the intact gastrointestinal (GI) tract. Chemicals not
absorbed through the GI tract are generally incapable of eliciting a
toxic response. These polymers have an oligomer content less than 10%
below molecular weight 500 and less than 25% molecular weight 1,000.

Vive Crop Protection, Inc. believes sufficient information was submitted
in the petition to assess the hazards of modified acrylic polymers. No
toxicology data were presented in the petition as the Agency does not
generally require that polymers conform to   HYPERLINK
"https://www.federalregister.gov/select-citation/2001/06/20/40-CFR-723.2
50"  40 CFR 723.250 . Based on these polymers conforming to the
definition of a polymer and meeting the criteria of a low risk polymer
under   HYPERLINK
"https://www.federalregister.gov/select-citation/2001/06/20/40-CFR-723.2
50"  40 CFR 723.250 , Vive Crop Protection, Inc. believes there are no
concerns for risks associated with toxicity.

	

	2. Genotoxicty. NA-Remove

	3. Reproductive and developmental toxicity. NA-Remove

	4. Subchronic toxicity. NA-Remove

	5. Chronic toxicity. NA-Remove

	6. Animal metabolism. NA-Remove

	7. Metabolite toxicology. NA-Remove

	8. Endocrine disruption. 

Endocrine disrupter. There is no evidence that modified acrylic polymers
are endocrine disrupters. Substances with molecular weights greater than
400 generally are not absorbed through the intact skin, and substances
with molecular weights greater than 1,000 generally are not absorbed
through the GI tract. Chemicals not absorbed through the skin or GI
tract generally are incapable of eliciting a toxic response.

C. Aggregate Exposure

	1. Dietary exposure. Some modified acrylic polymers may be used in
contact with food as components of containers used to manufacture,
process, or store food when regulated for such use under the Federal
Food, Drug, and Cosmetic Act.  Modified acrylic polymers with a
molecular weight greater than 1,000 daltons are not readily absorbed
through the intact gastrointestinal track and are considered incapable
of eliciting a toxic response.

	i. Food. NA-Remove

	ii. Drinking water. NA-Remove

	2. Non-dietary exposure. NA-Remove

D. Cumulative Effects

	There is data to support a conclusion of negligible cumulative risk for
modified acrylic polymers.  Polymers with molecular weights greater than
400 generally are not absorbed through the intact skin, and substances
with molecular weights greater than 1,000 generally are not absorbed
through the intact gastrointestinal (GI) track.  Chemicals not absorbed
through the skin or GI track generally are incapable of eliciting a
toxic response.  Therefore, there is no reasonable expectation of
increased risk due to cumulative exposure.  Based on how these polymers
conform to the definition of a polymer and meeting the criteria of low
risk polymers under 40 CFR 723.250, Vive Crop Protection, Inc. believes
there are no concerns for risk associated with cumulative effects.

E. Safety Determination

	1. U.S. population. NA-Remove

	2. Infants and children. NA-Remove

F. International Tolerances

	NA-Remove

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