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Methyl Esters of Tall-Oil Fatty Acids; Tolerance Exemption
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: May 29, 1996 (Volume 61, Number 104)]
[Proposed Rules]
[Page 26859-26861]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29my96-30]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 6E04666/P660; FRL-5371-6]
RIN 2070-AC18
Methyl Esters of Tall-Oil Fatty Acids; Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: This document proposes that methyl esters of tall-oil fatty
acids be exempted from the requirement of a tolerance when used as an
inert ingredient (adjuvant) in pesticide formulations. This proposed
regulation was requested by Union Camp Corporation pursuant to the
Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: Comments, identified by the docket number [PP 6E04666/P660],
must be received on or before June 28, 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, Crystal
Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
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. The public docket is 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 in 5.1 file format or ASCII file
format. All comments and data in electronic form must be identified by
the docket number, [PP 6E04666/P660]. 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), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location, telephone number, and e-mail address: 2800
Crystal Drive, North Tower, Arlington, VA, (703) 308-8380, e-mail:
gandhi.bipin@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: Union Camp Corporation, P.O.Box 2668,
Savannah, GA. 31402, has submitted pesticide petition (PP) 6E04666 to
EPA requesting that the Administrator, pursuant to section 408(e) of
the FFDCA, 21 U.S.C. 346a(e), propose to amend 40 CFR 180.1001(c) by
establishing an exemption from the requirement of a tolerance for
methyl esters of tall-oil fatty acids when used as an inert ingredient
(adjuvant) in pesticide formulations applied to growing crops or to raw
agricultural commodities after harvest.
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 intended 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 methyl esters of tall-
oil fatty acids will need to be submitted. The rationale for this
decision is described below:
(1) Tall-oil fatty acids are exempted from the requirement of a
tolerance under 40 CFR 180.1001(c) as ``Tall-oil; fatty acids not less
than 58 percent, rosin acids not more than 44 percent, unsaponifiables
not more than 8 percent.''
[[Page 26860]]
(2) Methyl esters of tall-oil fatty acids are prepared from tall-
oil fatty acids. These methyl esters degrade to tall-oil fatty acids
and therefore, are considered no more toxic than the corresponding
tall-oil fatty acids.
(3) Methyl esters (distilled) of tall-oil fatty acids contain 1 to
5 percent rosin acids and 2 percent unsaponifiables and are therefore
expected to be less toxic compared to the maximum permitted levels of
44 percent rosin acids and 8 percent unsaponifiables respectively for
tall-oil fatty acids specified under 40 CFR 180.1001(c).
Based upon 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, which contains any of the
ingredients listed herein, may request within 30 days after publication
of this document in the Federal Register that this proposal be referred
to an Advisory Committee in accordance with section 408(e) of FFDCA.
Interested persons are invited to submit written comments on the
proposed regulation. Comments must bear a notation indicating the
docket number, [PP 6E04666/P660].
A record has been established for this rulemaking under docket
number [PP 6E04666/P660] (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 ``ADDRESSES '' at the
beginning of this document.
The Office of Management and Budget has exempted this proposed rule
from the requirements of section 3 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 requirements of the Regulatory Flexibility Act
(Pub. L. 96-3 54, 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 a significant 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: May 16, 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 to paragraph (c) is amended by
adding alphabetically the inert ingredient ``Methyl esters of tall-oil
fatty acids,'' to read as follows:
Sec. 180.1001 Exemptions from the requirements of a tolerance.
* * * * *
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Ingredients Limits Uses
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* * * * * * *
Methyl esters of tall-oil .............. Adjuvant
fatty acids. (Fatty acids
not less than 58 percent,
rosin acids not less than 44
percent unsaponifiables not
less than 8 percent).
* * * * * * *
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[[Page 26861]]
[FR Doc. 96-13441 Filed 5-28-96; 8:45 am]
BILLING CODE 6560-50-F