[Federal Register Volume 59, Number 119 (Wednesday, June 22, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-15078]


[[Page Unknown]]

[Federal Register: June 22, 1994]



-----------------------------------------------------------------------


ENVIRONMENTAL PROTECTION AGENCY
 

40 CFR Part 180

[OPP-300345; FRL-4868-6]
RIN 2070-AC18

Ethyl Oleate; Tolerance Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: This document proposes that ethyl oleate (ethyl esters of 
fatty acids derived from edible fats and oils) be exempted from the 
requirement of a tolerance when used as an inert ingredient (solvent, 
cosolvent) in pesticide formulations applied to growing crops or raw 
agricultural commodities after harvest. This proposed regulation was 
requested by Victorian Chemicals.

DATES: Written comments, identified by the document control number 
[OPP-300345], must be received on or before July 22, 1994.

ADDRESSES: By mail, submit written comments to: Public Response 
Section, Field Operations Division (7506C), Office of Pesticide 
Programs, Environmental Protection Agency, 401 M St., SW., Washington, 
DC 20460. In person, bring comments to: Rm. 1128, 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 may be disclosed publicly by EPA without prior notice. All 
written comments will be available for public inspection in Rm. 1128 at 
the Virginia address given above, from 8 a.m. to 4 p.m., Monday through 
Friday, excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: By mail: Tina Levine, Registration 
Support Branch, Registration Division (7505C), Environmental Protection 
Agency, 401 M St., SW., Washington, DC 20460. Office location and 
telephone number: 2800 Crystal Drive, North Tower, Arlington, VA 22202, 
(703)-308-5971.

SUPPLEMENTARY INFORMATION: Victorian Chemical Co. Pty. Ltd., 37-49 
Appleton St., P.O. Box 71, Richmond, Victoria, 3121 Australia, 
submitted pesticide petition (PP) 4E4303 to EPA requesting that the 
Administrator, pursuant to section 408(e) of the Federal Food, Drug, 
and Cosmetic Act, 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 ethyl oleate (ethyl esters of fatty acids derived from 
edible fats and oils) when used as a solvent or cosolvent in pesticide 
formulations applied to growing crops or 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 statment 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 ethyl oleate will need to be 
submitted. The rationale for this decision is described below.
    1. Ethyl oleate, as defined, is expected to be metabolized to ethyl 
alcohol and edible fatty acids, rendering it of minimal toxicological 
concern.
    2. There is no significant difference between ethyl oleate and 
methyl oleate, which is approved under 40 CFR 180.1001(c). In fact, as 
noted by the FDA (57 FR 12709, Apr. 13, 1992), on an equal basis, 
methyl esters of fatty acids have more toxic potential than the ethyl 
esters because of the potential for the release of methyl alcohol.
    3. The FDA has approved ethyl oleate as a direct food additive in 
aqueous emulsions for dehydrating grapes to produce raisins under 21 
CFR 172.225.
    Based upon the above information and review of its use, EPA has 
found that, when used in accordance with good agricultural practice, 
this ingredeint 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, 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 rulemaking proposal be 
referred to an Advisory Committee in accordance with section 408(e) of 
the Federal Food, Drug, and Cosmetic Act.
    Interested persons are invited to submit written comments on the 
proposed regulation. Comments must bear a notation indicating the 
document control number, [OPP-300345]. All written comments filed in 
response to this document will be available for public inspection in 
the Public Response and Program Resources Branch, at the Virginia 
address given above, from 8 a.m. to 4 p.m., Monday through Friday, 
except legal holidays.
    The Office of Management and Budget has exempted this rule from the 
requirements of Executive Order 12866.
    Pursuant to the requirements 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 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, Food additives, Pesticides and pests, 
Reporting and recordkeeping requirements.

Dated: June 7, 1994.

Stephen L. Johnson,
Acting Director, Registration Divison, 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. Section 180.1001(c) is amended in the table therein by adding 
and alphabetically inserting the inert ingredient, to read as follows:


Sec. 180.1001   Exemptions from the requirement of a tolerance.

*      *      *    *      *
    (c) *  *  *

------------------------------------------------------------------------
               Inert ingredients                   Limits        Uses   
------------------------------------------------------------------------
                                                                        
                                 *******                                
Ethyl esters of fatty acids derived from                                
 edible fats and oils.........................                  Solvent,
                                                               cosolvent
                                                                        
                                 *******                                
------------------------------------------------------------------------

*    *    *    *    *

[FR Doc. 94-15078 Filed 6-21-94; 8:45 am]
BILLING CODE 6560-50-F