[Federal Register Volume 61, Number 139 (Thursday, July 18, 1996)]
[Proposed Rules]
[Pages 37432-37435]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17925]


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[[Page 37433]]


ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180

[OPP-300429; FRL-5376-4]
RIN 2070-AC18


Vinyl Alcohol-Vinyl Acetate Copolymer, Benzaldehyde-o-Sodium 
Sulfonate Condensate; 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 vinyl alcohol-vinyl acetate 
copolymer, benzaldehyde-o-sodium sulfonate condensate when used as an 
inert ingredient (water soluble resin) in pesticide formulations 
applied to growing crops or to raw agricultural commodities after 
harvest and when applied to animals. This proposed regulation was 
requested by Mitsui Plastics, Inc.
DATES: Written comments, identified by the docket number [OPP-300429], 
must be received on or before August 19, 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, 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.
    Comments and data may also be submitted electronically by sending 
electronic mail (e-mail) to: 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. 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 [OPP-300429]. No 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 below in this document.

FOR FURTHER INFORMATION CONTACT: By mail: 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: 
gandhi.bipin@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: Mitsui Plastics, Inc., 11 Martine Ave, White 
Plains, NY 10606, submitted pesticide petition (PP) 6E4718 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 180.1001(c) and (e) by establishing an 
exemption from the requirement of a tolerance for residues of vinyl 
alcohol-vinyl acetate copolymer, benzaldehyde-o-sodium sulfonate 
condensate when used as an inert ingredient (water soluble resin) 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; 
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 vinyl alcohol-vinyl 
acetate copolymer, benzaldehyde-o-sodium sulfonate condensate 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. Vinyl alcohol-vinyl acetate copolymer, 
benzaldehyde-o-sodium sulfonate condensate 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. Vinyl alcohol-vinyl acetate copolymer, benzaldehyde-o-sodium 
sulfonate condensate is not a cationic polymer, nor is it reasonably 
anticipated to become a cationic polymer in a natural aquatic 
environment.
    2. Vinyl alcohol-vinyl acetate copolymer, benzaldehyde-o-sodium 
sulfonate condensate contains as an integral part of its composition 
the atomic elements carbon, hydrogen, oxygen, sodium and sulfur.
    3. Vinyl alcohol-vinyl acetate copolymer, benzaldehyde-o-sodium 
sulfonate condensate 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. Vinyl alcohol-vinyl acetate copolymer, benzaldehyde-o-sodium 
sulfonate condensate is not designed, nor is it reasonably anticipated 
to substantially degrade, decompose or depolymerize.
    5. Vinyl alcohol-vinyl acetate copolymer, benzaldehyde-o-sodium 
sulfonate condensate 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.

[[Page 37434]]

    6. Vinyl alcohol-vinyl acetate copolymer, benzaldehyde-o-sodium 
sulfonate condensate is not a water absorbing polymer with a number 
average molecular weight greater than or equal to 10,000 daltons.
    7. The minimum number-average molecular weight of vinyl alcohol-
vinyl acetate copolymer, benzaldehyde-o-sodium sulfonate condensate is 
20,000 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) tract. Chemicals not absorbed through 
the skin or GI tract generally are incapable of eliciting a toxic 
response.
    8. Vinyl alcohol-vinyl acetate copolymer, benzaldehyde-o-sodium 
sulfonate condensate has a minimum number average molecular weight of 
20,000 and contains less than 2 percent oligomeric material below 
molecular weight 500 and less than 5 percent oligomeric material below 
1,000 molecular weight.
    9. Vinyl alcohol-vinyl acetate copolymer, benzaldehyde-o-sodium 
sulfonate condensate does contain aliphatic hydroxy groups, aliphatic 
ester groups, diacetal groups and sodium sulfonate groups as reactive 
functional groups. However, these reactive groups are not intended or 
reasonably anticipated to undergo further reactions.
    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, [OPP-300429].
    A record has been established for this rulemaking under docket 
number [OPP-300429] (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-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'' 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.
    This action does not impose any enforceable duty, or contain any 
``unfunded mandates'' as described in Title II of the Unfunded Mandates 
Reform Act of 1995 (Pub. L. 104-4), or require prior consultation as 
specified by Executive Order 12875 (58 FR 58093, October 28, 1993), 
entitled Enhancing the Intergovernmental Partnership, or special 
consideration as required by Executive Order 12898 (59 FR 7629, 
February 16, 1994).
    Pursuant to the requirement of the Regulatory Flexibility Act (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, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: June 25, 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 table in paragraphs (c) and (e), is 
amended by adding alphabetically the inert ingredient ``Vinyl alcohol-
vinyl acetate copolymer, benzaldehyde-o-sodium sulfonate condensate, 
minimum number average molecular weight (in amu) 20,000,'' to read as 
follows:


Sec. 180.1001  Exemptions from the requirement of a tolerance.

* * * * *

    (c) *       *       *

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      Inert ingredients             Limits                 Uses         
------------------------------------------------------------------------
                                                                        
         *        *        *        *        *        *        *        
Vinyl alcohol-vinyl acetate                       Water soluble resin   
 copolymer,benzaldehyde-o-                                              
 sodium sulfonate condensate,                                           
 minimum number average                                                 
 molecular weight (in amu)                                              
 20,000.                                                                
                                                                        
         *        *        *        *        *        *        *        
------------------------------------------------------------------------

*      *      *      *      *
    (e) *      *       *

[[Page 37435]]



------------------------------------------------------------------------
      Inert ingredients             Limits                 Uses         
------------------------------------------------------------------------
                                                                        
         *        *        *        *        *        *        *        
Vinyl alcohol-vinyl acetate                       Water soluble resin   
 copolymer,benzaldehyde-o-                                              
 sodium sulfonate condensate,                                           
 minimum number average                                                 
 molecular weight (in amu)                                              
 20,000.                                                                
                                                                        
         *        *        *        *        *        *        *        
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[FR Doc. 96-17925 Filed 7-17-96; 8:45 am]
BILLING CODE 6560-50-F