[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: [email protected]. 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: 
[email protected].

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-D[email protected]
    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