[Federal Register Volume 59, Number 38 (Friday, February 25, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-4378]
[[Page Unknown]]
[Federal Register: February 25, 1994]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300324; FRL-4760-7]
RIN 2070-AC18
Cetyl Alcohol; Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: This document proposes that an exemption from the requirement
of a tolerance be established for residues of cetyl alcohol (CAS Reg.
No. 36653-82-4) when used as an inert ingredient (evaporation
retardant) in pesticide formulations applied to growing crops or to raw
agricultural commodities after harvest. This proposed regulation was
requested by Roussel Uclaf Corp.
DATES: Comments, identified by the document control number [OPP-
300324], must be received on or before March 28, 1994.
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. 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 will be included in the public docket by the EPA without
prior notice. The public docket is available for public inspection in
Rm. 1128 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: Rosalind L. Gross,
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: 6th Floor,
CS #1, 2800 Crystal Drive, North Tower, Arlington, VA 22202, (703)-308-
8354.
SUPPLEMENTARY INFORMATION: Roussel Uclaf Corp., 95 Chestnut Ridge Rd.,
P.O. Box 30, Montvale, NJ 07645, submitted pesticide petition (PP)
3E4207 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) to exempt from the requirement of a
tolerance residues of cetyl alcohol (CAS Reg. No. 36653-82-4) when used
as an inert ingredient (evaporation retardant) 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. Where it can be determined that the inert
ingredient will present minimal or no risk, the Agency may waive some
or all of the listed studies. The Agency has decided that no additional
data will need to be submitted to support the proposed tolerance
exemption for cetyl alcohol. The rationale for this decision is
described below.
1. Cetyl alcohol is approved for use as a direct food additive
under 21 CFR 172.515 (synthetic flavoring substances and adjuvants).
2. Cetyl alcohol is contained in a drug recently approved by the
Food and Drug Administration for use as a direct spray into the lungs
of newborns in order to prevent and/or treat idopathic respiratory
distress syndrome.
3. Cetyl alcohol is approved for use as an indirect food additive
under 21 CFR 175.105, 21 CFR 175.300 (indirect food additives:
adhesives and components of coatings), 21 CFR 176.200, 21 CFR 176.210
(indirect food additives: paper and paperboard components), 21 CFR
177.1200, 21 CFR 177.1210, 21 CFR 177.1350, 21 CFR 177.1400, and 21 CFR
177.2800 (indirect food additives: polymers), and 21 CFR 178.3910
(indirect food additives: adjuvants, production aids, and sanitizers).
The Agency has reviewed the supporting literature for the
aforementioned FDA clearances on cetyl alcohol. This review supports
the use of cetyl alcohol as an evaporation retardant in pesticide
formulations applied to growing crops or to raw agricultural
commodities after harvest, at concentrations of not more than 5.0
percent of the pesticide formulation. Based upon the above information
and review of its use, EPA has found that, when used in accordance with
good agricultural practices, 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-300324]. 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 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
Administrative practice and procedure, Agricultural commodities,
Pesticides and pests, Recording and recordkeeping requirements.
Dated: February 14, 1994.
Stephanie R. Irene,
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 entry for cetyl alcohol, to read as
follows:
Sec. 180.1001 Exemptions from the requirement of a tolerance.
* * * * *
(c) * * *
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
Cetyl alcohol (CAS Reg. Not more than 5.0% Evaporation retardant
No. 36653-82-4). of pesticide
formulation.
* * * * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 94-4378 Filed 2-24-94; 8:45 am]
BILLING CODE 6560-50-F