[Federal Register Volume 60, Number 206 (Wednesday, October 25, 1995)]
[Proposed Rules]
[Pages 54643-54645]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-26060]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300398; FRL-4981-1]
RIN 2070-AB78
Styrene-2-Ethylhexyl Acrylate-Glycidyl Methacrylate-2-Acrylamido-
2-Methylpropanesulfonic Acid Graft Copolymer; Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: This document proposes to establish an exemption from the
requirement of a tolerance for residues of styrene-2-ethylhexyl
acrylate-glycidyl methacrylate-2-acrylamido-2-methylpropanesulfonic
acid graft copolymer when used as an inert ingredient (dispersing
agent/solvent) in pesticide formulations applied to growing crops or to
raw agricultural commodities after harvest. Dow Chemical Co. requested
this proposed regulation pursuant to the Federal Food, Drug and
Cosmetic Act (FFDCA).
DATES: Written comments, identified by the document control number
[OPP-300398], must be received on or before November 24, 1995.
ADDRESSES: By mail, submit written comments to Public Response and
Program Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. In person, deliver comments to: Rm. 1132, CM #2,
1921 Jefferson Davis Hwy., Arlington, VA 22202. Information submitted
as a comment concerning this document may be claimed confidential by
marking any part or all of that information as ``Confidential Business
Information'' (CBI). Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
comment that does not contain CBI must be submitted for inclusion in
the public record. Information not marked confidential will be included
in the public docket by EPA without prior notice. All written comments
will be available for public inspection in Rm. 1132 at the address
given above, from 8 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: opp-docket@epamail.epa.gov. Copies of objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect in 5.1
file format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket number
[OPP-300398]. No Confidential Business Information (CBI) should be
submitted through e-mail. Electronic copies of objections and hearing
requests on this rule may be filed online at many Federal Depository
Libraries. Additional information on electronic submissions can be
found below in this document.
FOR FURTHER INFORMATION CONTACT: By mail: Rita Kumar, Registration
Support Branch, Registration Division (7505W), Environmental Protection
Agency, 401 M St., SW., Washington, DC 20460. Office location and
telephone number: 2800 Crystal Drive, North Tower, 6th Floor,
Arlington, VA 22202, (703)-308-8811; e-mail:
kumar.rita@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: Dow Chemical Co., 1803 Building, Midland, MI
48674-1803, has submitted pesticide petition (PP) 5E04461 to EPA
requesting that the Administrator, pursuant to section 408(e) of the
Federal Food Drug, and Cosmetic Act (FFDCA) (21 U.S.C.
[[Page 54644]]
346a(e)), propose to amend 40 CFR 180.1001(c) by exempting styrene-2-
ethylhexyl acrylate-glycidyl methacrylate-2-acrylamido-2-
methylpropanesulfonic acid graft copolymer when used as an inert
ingredient (dispersing agent/solvent) in pesticide formulations applied
to growing crops or to raw agricultural commodities after harvest,
under 40 CFR 180.1001(c). The inert ingredient meets the definition of
a polymer under 40 CFR section 723.250(b) and the criteria listed in 40
CFR section 723.250(e) that define a chemical substance that poses no
unreasonable risk under section 5 of the Toxic Substance Control Act
(TSCA).
Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125, and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not to imply nontoxicity; the
ingredient may or may not be chemically active.
The data submitted in the petition and other relevant material have
been evaluated. As part of the EPA policy statement on inert
ingredients published in the Federal Register of April 22, 1987 (52 FR
13305), the Agency set forth a list of studies which would generally be
used to evaluate the risks posed by the presence of an inert ingredient
in a pesticide formulation. However, where it can be determined without
that data that the inert ingredient will present minimal or no risk,
the Agency generally does not require some or all of the listed studies
to rule on the proposed tolerance or exemption from the requirement of
a tolerance for an inert ingredient. The Agency has decided that no
data, in addition to that described below, for styrene-2-ethylhexyl
acrylate-glycidyl methacrylate-2-acrylamido-2-methylpropanesulfonic
acid graft copolymer will need to be submitted. The rationale for this
decision is described below.
In the case of certain chemical substances that are defined as
``polymers,'' the Agency has established a set of criteria which
identify categories of polymers that present low risk. These criteria
(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. These properties
generally limit a polymer's ability to cause adverse effects. In
addition, these criteria exclude polymers about which little is known.
The Agency believes that polymers meeting the criteria noted above will
present minimal or no risk.
Styrene-2-ethylhexyl acrylate-glycidyl methacrylate-2-acrylamido-2-
methylpropanesulfonic acid graft copolymer conforms to the definition
of a polymer in 40 CFR 723.250(b) and meets the following criteria that
are used to identify low-risk polymers:
1. Styrene-2-ethylhexyl acrylate-glycidyl methacrylate-2-
acrylamido-2-methylpropanesulfonic acid graft copolymer is not a
cationic polymer, nor is it reasonably anticipated to become a cationic
polymer in a natural aquatic environment.
2. Styrene-2-ethylhexyl acrylate-glycidyl methacrylate-2-
acrylamido-2-methylpropanesulfonic acid graft copolymer contains as an
integral part of its composition the atomic elements carbon, hydrogen,
oxygen, nitrogen, and sulfur.
3. Styrene-2-ethylhexyl acrylate-glycidyl methacrylate-2-
acrylamido-2-methylpropanesulfonic acid graft copolymer 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).
4. Styrene-2-ethylhexyl acrylate-glycidyl methacrylate-2-
acrylamido-2-methylpropanesulfonic acid graft copolymer is not
designed, nor is it reasonably anticipated to substantially degrade,
decompose, or depolymerize.
5. Styrene-2-ethylhexyl acrylate-glycidyl methacrylate-2-
acrylamido-2-methylpropanesulfonic acid graft copolymer is not
manufactured or imported from monomers and/or other reactants that are
not already included on the TSCA Chemical Substance Inventory or
manufactured under an applicable TSCA section 5 exemption.
6. Styrene-2-ethylhexyl acrylate-glycidyl methacrylate-2-
acrylamido-2-methylpropanesulfonic acid graft copolymer is not a water-
absorbing polymer.
7. The minimum number-average molecular weight of styrene-2-
ethylhexyl acrylate-glycidyl methacrylate-2-acrylamido-2-
methylpropanesulfonic acid graft copolymer is 12,500 daltons.
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 intact
gastrointestinal (GI) tract. Chemicals not absorbed through skin or GI
tract generally are incapable of eliciting a toxic response.
8. Styrene-2-ethylhexyl acrylate-glycidyl methacrylate-2-
acrylamido-2-methylpropanesulfonic acid graft copolymer has a number
average molecular weight of 12,500, and contains oligormeric content
less than 2 percent below MW 500 and less than 5 percent below MW
1,000.
9. Styrene-2-ethylhexyl acrylate-glycidyl methacrylate-2-
acrylamido-2-methylpropanesulfonic acid graft copolymer does not
contain reactive functional groups that are intended or reasonably
anticipated to undergo further reaction.
Based on the information above and review of its use, EPA has found
that, when used in accordance with good agricultural practice, this
ingredient is useful, and a tolerance is not necessary to protect the
public health. Therefore, EPA proposes that the exemption from the
requirement of a tolerance be established as set forth below.
Any person who has registered or submitted an application for
registration of a pesticide, under the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA) as amended, that contains any of the
ingredients listed herein, may request within 30 days after the
publication of this document in the Federal Register that this
rulemaking proposal be referred to an Advisory Committee in accordance
with section 408(e) of the FFDCA.
Interested persons are invited to submit written comments on the
proposed regulation. Comments must bear a notation indicating the
document control number, [OPP-300398]. All written comments filed in
response to this petition will be available in the Public Response and
Program Resources Branch, at the address given above, from 8 a.m. to
4:30 p.m., Monday through Friday, except legal holidays.
A record has been established for this rulemaking under docket
number [OPP-300398] (including comments and data submitted
electronically as described below). A public version of this record,
including printed paper versions of electronic comments, which does not
include any information claimed as CBI, is available for inspection
from 8 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The public record is located in Room 1132 of the Public
Response and Program Resources Branch, Field Operations Division
(7506C), Office of Pesticide Programs, Environmental Protection Agency,
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
[[Page 54645]]
Electronic comments can be sent directly to EPA at:
opp-Docket@epamail.epa.gov
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer all comments received electronically into printed,
paper form as they are received and will be placed in the paper copies
of the official rulemaking record which also will include all comments
submitted directly in writing. The official rulemaking record is the
paper record maintained at the address in the ``ADDRESSES'' section at
the beginning of this document.
The Office of Management and Budget has exempted this rule from the
requirements of section 2 of Executive Order 12866.
Pursuant to the requirement of the Regulatory Flexibility Act (Pub.
L. 96-354, 94 Stat. 1164, 5 U.S.C. 601-612), the Administrator has
determined that regulations establishing new tolerances or raising
tolerance levels or establishing exemptions from tolerance requirements
do not have an economic impact on a substantial number of small
entities. A certification statement to this effect was published in the
Federal Register of May 4, 1981 (46 FR 24950).
List of Subject in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: September 27, 1995.
Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR part 180 be amended as
follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. Section 180.1001(c) is amended in the table therein by adding
and alphabetically inserting the inert ingredient, to read as follows:
Sec. 180.1001 Exemptions from the requirement of a tolerance.
* * * * *
(c) * * *
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Inert ingredients Limits Uses
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* * * * * * *
Styrene-2-ethylhexyl acrylate- .............. Dispersing agent/
glycidyl methacrylate-2- solvent.
acrylamido-2-
methylpropanesulfonic acid
graft copolymer, minimum
number-average molecular
weight 12,500.
* * * * * * *
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[FR Doc. 95-26060 Filed 10-24-95; 8:45 am]
BILLING CODE 6560-50-F
