[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.Amelia@epamail.epa.gov.
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) * * *
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Inert ingredients Limits Uses
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* * * * *
* *
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
