[Federal Register Volume 61, Number 133 (Wednesday, July 10, 1996)]
[Proposed Rules]
[Pages 36329-36331]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17575]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300425; FRL-5374-3]
RIN 2070-AC18
Maleic Anhydride-Diisobutylene Copolymer, Sodium Salt; 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 maleic anhydride-
diisobutylene copolymer, sodium salt when used as an inert ingredient
(suspending agent and dispersing agent) in pesticide formulations
applied to growing crops, raw agricultural commodities after harvest,
and applied to animals. This proposed regulation was requested by
Rhone-Poulenc North America Chemicals, Inc.
DATES: Written comments, identified by the docket number [OPP-300425],
must be received on or before August 9, 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 Virginia
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-300425]. 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 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: Rhone-Poulenc North America Chemicals, Inc.,
CN 5255, Princeton, NJ 08543-5255 submitted pesticide petition (PP)
6E04665 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), (d) and (e) by
establishing an exemption from the requirement of a tolerance without
limitation for residues of maleic anhydride-diisobutylene copolymer,
sodium salt (CAS Reg. No. 37199-81-1), when used as an inert ingredient
(suspending agent and dispersing 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), and deleting the current exemption from the requirement of
a tolerance with a use limitation of 3 percent under 40 CFR 1001(d) for
application to growing crops only.
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 maleic anhydride-
diisobutylene copolymer, sodium salt 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. Maleic anhydride-diisobutylene copolymer,
sodium salt conforms to the definition of polymer given in 40 CFR
723.250(b) and meets the following
[[Page 36330]]
criteria that are used to identify low risk polymers:
1. Maleic anhydride-diisobutylene copolymer, sodium salt is not a
cationic polymer, nor is it reasonably anticipated to become a cationic
polymer in a natural aquatic environment.
2. Maleic anhydride-diisobutylene copolymer, sodium salt contains
as an integral part of its composition the atomic elements carbon,
hydrogen, oxygen, and sodium.
3. Maleic anhydride-diisobutylene copolymer, sodium salt 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. Maleic anhydride-diisobutylene copolymer, sodium salt is not
designed, nor it is reasonably anticipated to substantially degrade,
decompose or depolymerize.
5. Maleic anhydride-diisobutylene copolymer, sodium salt 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. Maleic anhydride-diisobutylene copolymer, sodium salt is not
water absorbing polymer.
7. The minimum number-average molecular weight of maleic anhydride-
diisobutylene copolymer, sodium salt is 20,900 daltons. Substances with
molecular weights (MW) greater than 400 generally are not absorbed
through the intact skin, and substances with MW 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. Maleic anhydride-diisobutylene copolymer, sodium salt has a
number average molecular weight of 20,900 and an oligomer content less
than 2 percent below 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 tolerance is not necessary to protect the
public health. Therefore, EPA proposes that the exemptions from the
requirement of a tolerance be established for this polymer 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-300425].
A record has been established for this rulemaking under docket
number [OPP-300425] (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 place the paper copies in the
official rulemaking record which will also 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 (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, Food additives, Pesticides and pests,
Processed foods, Reporting and recordkeeping requirements.
Dated: July 1, 1996.
Peter Caulkins,
Acting 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, paragraphs (c) and (e), the table in each
paragraph is amended by adding alphabetically the inert ingredient
``Maleic anhydride-dissobutylene copolymer, sodium salt (CAS Reg. No.
37199-81-8), average molecular weight (in amu) 18,000,'' to read as set
forth below, and the table in paragraph (d) is amended by removing the
entry for ``Maleic anhydride dissobutylene copolymer, sodium salt.''
Sec. 180.1001 Exemptions from the requirement of a tolerance.
* * * * *
(c) * * *
[[Page 36331]]
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Inert Ingredient Limits Uses
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* * * * * * *
Maleic anhydride-dissobutylene Suspending agent and
copolymer, sodium salt (CAS Reg. dispersing agent.
No. 37199-81-8), average
molecular weight (in amu) 18,000..
* * * * * * *
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* * * * *
(e) * * *
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Inert Ingredient Limits Uses
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* * * * * * *
Maleic anhydride-dissobutylene Suspending agent and
copolymer, sodium salt (CAS Reg. dispersing agent.
No. 37199-81-8), average
molecular weight (in amu) 18,000.
* * * * * * *
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[FR Doc. 96-17575 Filed 7-9-96; 8:45 am]
BILLING CODE 6560-50-F
