[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
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* * * * * * *
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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* * * * *
(e) * * *
[[Page 37435]]
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Inert ingredients Limits Uses
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* * * * * * *
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
