[Federal Register Volume 60, Number 70 (Wednesday, April 12, 1995)]
[Proposed Rules]
[Pages 18557-18558]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-8730]



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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180

[OPP-300384; FRL-4945-7]
RIN 2070-AC18


Oleyl Alcohol; Tolerance Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: This document proposes that oleyl alcohol (CAS Reg. No. 143-
28-2) be exempted from the requirement of a tolerance when used as a 
cosolvent in pesticide formulations applied to growing crops or to raw 
agricultural commodities after harvest. Henckel Corp., Emery Group, 
requested this proposed regulation.

DATES: Comments, identified by the document control number [OPP-
300384], must be received on or before May 12, 1995.

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, Building #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202.
    Information submitted as a comment concerning this document may be 
claimed confidential by marking any part of 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 the 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 p.m., Monday 
through Friday, excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: By mail: Amelia M. Acierto, 
Registration Support Branch, Registration Division (7505W), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460. Office location and telephone number: 2800 
Crystal Drive, North Tower, Arlington, VA 22202, (703)-308-8375; e-
mail: Acierto.A[email protected].

SUPPLEMENTARY INFORMATION: Henkel Corp., Emery Group, 4900 Este Ave., 
Cincinnati, OH 45232-1491, submitted pesticide petition (PP) 4E4335 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 oleyl alcohol when used as a cosolvent 
in pesticide formulations applied to growing crops and 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 established data requirements which will be used to 
evaluate the risks posed by the presence of an inert ingredient in a 
pesticide formulation. Exemptions from some or all of the requirements 
may be granted if it can be determined that the inert ingredient will 
present minimal or no risk. The Agency has decided that the data 
normally required to support the proposed tolerance exemption for oleyl 
alcohol will not need to be submitted. The rationale for this decision 
is described below: [[Page 18558]] 
    1. Available data demonstrate that oleyl alcohol is no more than 
slightly toxic to mammals, fish, and aquatic invertebrates.
    2. Oleyl alcohol is found in fish oils and one of its uses is as a 
carrier for medicaments. Anticipated residues of oleyl alcohol at the 
proposed level of use are expected to be of little or no toxicological 
significance.
    3. Oleyl alcohol is approved by the Food and Drug Administration 
for use as a component of paper and paperboard under 21 CFR 176.170, as 
defoaming agent under 21 CFR 176.210, and as a component of animal glue 
under 21 CFR 178.3120.
    Based upon the above information and review of its use, the Agency 
does not believe that a potential for significant hazard exists when 
used in accordance with good agricultural practice. The Agency believes 
and that 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 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-300384]. All written comments filed in 
response to this petition will be available in the Public Response and 
Program Resources Branch, at the 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 section 3 of Executive Order 12866.
    Pursuant to the requirements of the Regulatory Flexibility Act 
(Pub. L. 96-354 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: March 29, 1995.

James J. Jones,
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. 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 requirements of a tolerance.

* * * * *
    (c) *  *  *

------------------------------------------------------------------------
    Inert ingredients            Limits                   Uses          
------------------------------------------------------------------------
                                                                        
  *                *                *                *                * 
                          *                *                            
Oleyl alcohol (CAS Reg.    15%...............  Cosolvent                
 No 143-28-2).                                                          
                                                                        
  *                 *                *                *                *
                           *                *                           
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* * * * *

[FR Doc. 95-8730 Filed 4-11-95; 8:45 am]
BILLING CODE 6560-50-F