[Federal Register Volume 61, Number 104 (Wednesday, May 29, 1996)]
[Proposed Rules]
[Pages 26859-26861]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-13441]



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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: [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 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: 
[email protected].

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:
    [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 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