[Federal Register Volume 61, Number 96 (Thursday, May 16, 1996)]
[Proposed Rules]
[Pages 24738-24740]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-12195]



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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180

[PP-5E04568/P653; FRL-5365-3]
RIN 2070-AB18


2-Propene-1-Sulfonic Acid, Sodium Salt, Polymer With Ethenol and 
Ethenyl Acetate; 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 2-propene-1-sulfonic acid, 
sodium salt, polymer with ethenol and ethenyl acetate (CAS Reg. No. 
107568-10-5) when used as an inert ingredient (binding agent) in 
pesticide formulations applied to growing crops or to raw agricultural 
commodities after harvest, under 40 CFR 180.1001(c) and applied to 
animals under 40 CFR 180.1001(e). This proposed regulation was 
requested by Japan Technical Information Center on behalf of Nippon 
Goshei (U.S.A.) Co., Ltd.
DATES: Written comments, identified by the document control number [PP-
5E04568/P653], must be received on or before June 17, 1996.

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, bring comments to: Rm. 1132 CM #2, 
1921 Jefferson Davis Highway, Arlington, VA 22202.
    Comments and data may also be submitted electronically by sending 
electronic mail (e-mail) to: [email protected]. Electronic 
comments must be submitted as an ASCII file avoiding the use of special 
characters and any form of encryption. Comments and data will also be 
accepted on disks in WordPerfect 5.1 file format or ASCII file format. 
All comments and data in electronic form must be identified by the 
docket number PP-5E04568/P653. No Confidential Business Information 
(CBI) should be submitted through e-mail. Electronic comments on this 
proposed rule may be filed online at many Federal Depository Libraries. 
Additional information on electronic submissions can be found in the 
SUPPLEMENTARY INFORMATION section of this document.
    Information submitted as a comment concerning this notice 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 may be disclosed publicly 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.

FOR FURTHER INFORMATION CONTACT: By mail: Dr. Bipin Gandhi, 
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) 308-8380, e-mail: 
[email protected].
SUPPLEMENTARY INFORMATION: Japan Technical Information Center, 775 
South 23rd Street, Arlington, VA 22202, submitted pesticide petition 
(PP) 5E04568 to EPA requesting that the Administrator, pursuant to 
section 408(e) of the Federal Food Drug, and Cosmetic Act (FFDCA) (21 
U.S.C. 346 a(e)), propose to amend 40 CFR part 180.1001(c) and (e) by 
establishing an exemption from the requirement of tolerance for 
residues of 2-propene-1-sulfonic acid, sodium salt, polymer with 
ethenol and ethenyl acetate when used as an inert ingredient (binding 
agent) in pesticide formulations applied to growing crops or to raw 
agricultural commodities after harvest and applied to animals. 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;

[[Page 24739]]

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 2-propene-1-sulfonic acid, sodium 
salt, polymer with ethenol and ethenyl acetate 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. 2-Propene-1-sulfonic acid, sodium salt, 
polymer with ethenol and ethenyl acetate 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:
    1. 2-Propene-1-sulfonic acid, sodium salt, polymer with ethenol and 
ethenyl acetate is not a cationic polymer, nor is it reasonably 
anticipated to become a cationic polymer in a natural aquatic 
environment.
    2. 2-Propene-1-sulfonic acid, sodium salt, polymer with ethenol and 
ethenyl acetate contains as an integral part of its composition the 
atomic elements carbon, hydrogen, oxygen, sulfur and sodium.
    3. 2-Propene-1-sulfonic acid, sodium salt, polymer with ethenol and 
ethenyl acetate 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. 2-Propene-1-sulfonic acid, sodium salt, polymer with ethenol and 
ethenyl acetate is not designed, nor is it reasonably anticipated to 
substantially degrade, decompose or depolymerize.
    5. 2-Propene-1-sulfonic acid, sodium salt, polymer with ethenol and 
ethenyl acetate 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. 2-Propene-1-sulfonic acid, sodium salt, polymer with ethenol and 
ethenyl acetate is not a water absorbing polymer.
    7. The minimum number-average molecular weight of 2-propene-1- 
sulfonic acid, sodium salt, polymer with ethenol and ethenyl acetate is 
listed as 6,000 to 12,000 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) track. Chemicals 
not absorbed through the skin or GI tract generally are incapable of 
eliciting a toxic response.
    8. 2-Propene-1-sulfonic acid, sodium salt, polymer with ethenol and 
ethenyl acetate has a number average molecular weight of 6,000 to 
12,000 daltons and contains an oligomer content of less than 2 percent 
below, molecular weight (MW) 500 and less than 5 percent MW 1000.
    Based on the above information 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 
docket number, [PP-5E04568/P653]. 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 [PP-5E04568/P653] (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.
    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'' 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 Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Food additives, Pesticides and pests, 
Processed foods, Reporting and recordkeeping requirements.


[[Page 24740]]


    Dated: May 7, 1996.

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. In Sec. 180.1001 the tables in paragraphs (c) and (e) are 
amended by adding alphabetically the inert ingredient, to read as 
follows:


Sec. 180.1001 Exemptions from the requirement of a tolerance.

*      *       *       *       *
    (c) * * *

------------------------------------------------------------------------
        Inert Ingredient                Limits               Uses       
------------------------------------------------------------------------
                                                                        
         *        *        *        *        *        *        *        
2-Propene-1-sulfonic acid,                           Binding Agent      
 sodium salt, polymer with                                              
 ethenol and ethenyl acetate,                                           
 number average molecular                                               
 weight (in amu) 6,000 - 12,000.                                        
                                                                        
         *        *        *        *        *        *        *        
------------------------------------------------------------------------

    (e) *        *        *

------------------------------------------------------------------------
        Inert Ingredient                Limits               Uses       
------------------------------------------------------------------------
                                                                        
         *        *        *        *        *        *        *        
2-Propene-1-sulfonic acid,                           Binding Agent      
 sodium salt, polymer with                                              
 ethenol and ethenyl acetate,                                           
 number average molecular                                               
 weight (in amu) 6,000 - 12,000.                                        
                                                                        
         *        *        *        *        *        *        *        
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[FR Doc. 96-12195 Filed 5-15-96; 8:45 am]
BILLING CODE 6560-50-F