[Federal Register Volume 61, Number 31 (Wednesday, February 14, 1996)]
[Proposed Rules]
[Pages 5728-5730]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-3018]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300412; FRL-4995-3]
RIN 2070-AC18
Oxo-Alkyl Acetates; Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: This document proposes that residues of a group of chemicals
known as oxo-alkyl acetates [oxo-hexylacetate (CAS Reg. No. 88230-35-
7), oxo-heptyl acetate (CAS Reg. No. 90438-79-2), oxo-octyl acetate
(CAS Reg. No. 108419-32-5), oxo-nonyl acetate (CAS Reg. No.108419-34-
7), oxo-decyl acetate (CAS Reg. No. 108419-33-6), and oxo-tridecyl
acetate (CAS Reg. No. 108419-35-8)] be exempted from the requirement of
a tolerance when used as a solvent in pesticide formulations. This
proposed regulation was requested by Exxon Chemical Co., Performance
Products Group.
DATES: Comments, identified by the docket control number [OPP-300412],
must be received on or before March 15, 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, D.C. 20460. In person deliver comments to: Rm. 1132,
Crystal Mall Building #2, 1921 Jefferson Davis Highway, Arlington, VA.
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 4:30 p.m., Monday
through Friday, excluding legal holidays.
Comments and data may also be submitted electronically by sending
electronic mail (e-mail) to: opp-docket@epamail.epa.gov. 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, [OPP-300412]. 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: 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, telephone number, and e-mail
address: 2800 Crystal Drive, North Tower, Arlington, VA, (703)-308-
8375; e-mail: acierto.amelia@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: Exxon Chemical Co., Performance Products
Group, Linden, NJ 07036, submitted pesticide petition (PP) 3E04267 to
EPA requesting that the Administrator, pursuant to section 408(e) of
the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e),
propose to amend 40 CFR 180.1001(d) by establishing an exemption from
the requirement of a tolerance for oxo-alkyl acetates [oxo-hexyl
acetate (CAS Reg. No. 88230-35-7), oxo-heptyl acetate (CAS Reg. No.
90438-79-2), oxo-octyl acetate (CAS Reg. No. 108419-32-5), oxo-nonyl
acetate (CAS Reg. No. 108419-34-7), oxo-decyl acetate (CAS Reg. No.
108419-33-6), and oxo-tridecyl acetate (CAS Reg. No. 108419-35-8)] when
used as solvents in pesticide formulations applied to growing crops
only.
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
[[Page 5729]]
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 data submitted for this petition are primarily for the oxo-
octyl acetate and oxo-tridecyl acetate for which the Agency has decided
are representative of the entire class of oxo-alkyl acetates having the
general structure CH3COOR where R is a branched alkyl group having
carbon numbers in the range of C6 through C14 and that no
data, in addition to that described below will need to be submitted.
The rationale for this decision is described below:
1. A subchronic oral toxicity study using oxo-octyl acetate in rats
with a No Observed Effect Level (NOEL) of 100 mg/kg/day and a Lowest
Effect Level (LEL) of 500 mg/kg/day based on increased liver weight in
both sexes which indicate an overall low degree of systemic toxicity
when administered orally to rats for 13 weeks.
2. A subchronic oral toxicity study using oxo-tridecyl acetate in
rats with a NOEL of 100 mg/kg and a LEL of 500 mg/kg based on increased
incidence of tubular nephropathy in the males and increased kidney and
liver weights in both sexes indicating an overall low degree of
systemic toxicity following subchronic oral administration of oxo-
tridecyl acetate in rats.
3. The microbial mutagenesis study including Salmonella mammalian
microsome plate incorporation assays showed no evidence that oxo-octyl
acetate or oxo-tridecyl acetate produces any mutagenic effects at any
dose tested, either with or without exogenous metabolic activation.
4. An in vivo mammalian bone marrow micronucleus assay oral gavage
dosing method did not significantly increase the frequency of
micronucleated polychromatic erythrocytes in mouse bone marrow at any
dose of oxo-octyl acetate or oxo-tridecyl acetate (625, 1,250 or 2,500
mg/kg body weight) or sampling time (24, 48, and 72 hours post-
treatment).
5. A developmental toxicity study with oxo-octyl acetate and oxo-
tridecyl acetate in rats with the maternal systemic NOEL of 100 mg/kg/
day and the maternal LOEL of 500 mg/kg based on decreased body weight
and the developmental toxicity NOEL of 500 mg/kg/day and the
developmental LOEL of 1,000 mg/kg based on increased incidence of
various types of vertebral malformations.
6. An acute oral toxicity study with an acute oral LD50 of
5,000 mg/kg in rats indicating that oxo-octyl acetate or oxo-tridecyl
acetate has little or no potential for hazard to rats.
7. An acute oral toxicity study with an acute oral LD50 of
greater than 2,250 mg/kg in bobwhite quail indicating that oxo-octyl
acetate or oxo-tridecyl acetate has little or no potential for hazard
to avian species.
8. A dietary study with LC50 of greater than 5,620 ppm in
bobwhite quail indicating that oxo-octyl acetate or oxo-tridecyl
acetate are practically nontoxic to avian species.
Based upon the above evaluation of the toxicological data which
shows no evidence of mutagenicity (Ames Test), and no significant acute
and subchronic or developmental toxicity of the branched alkyl acetates
in this molecular weight range (C8-C13 alkyl acetates), the
Agency concludes that this chemical poses no significant risks under
the proposed conditions of use and that no further data are required.
Based upon the toxicological data evaluated above, the physico-
chemical properties of oxo-alkyl acetates and information regarding
their use, the Agency has found that, when used in accordance with good
agricultural practice, these ingredients are 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 the
FFDCA.
Interested persons are invited to submit written comments on the
proposed regulation. Comments must bear a notation indicating the
docket control number, [OPP-300412]. 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.
A record has been established for this proposal under docket
number [OPP-300412] (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:
opp-docket@epamail.epa.gov
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 proposal, 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 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.
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, Pesticides and pests, Recording and
recordkeeping requirements.
Dated: January 31, 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. Section 180.1001(d) is amended by adding and alphabetically
inserting the
[[Page 5730]]
following inert ingredients, to read as follows:
Sec. 180.1001 Exemptions from the requirement of a tolerance.
* * * * *
(d) * * *
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Inert ingredients Limits Uses
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* * * * * * *
Oxo-decyl acetate (CAS reg. .............. Solvent
No. 108419-33-6).
Oxo-heptyl acetate (CAS Reg. .............. Solvent
No. 90438-79-2).
Oxo-hexyl acetate (CAS Reg. .............. Solvent
No. 88230-35-7).
Oxo-nonyl acetate (CAS Reg. .............. Solvent
No. 108419-34-7).
Oxo-octyl acetate (CAS Reg. .............. Solvent
No. 108419-32-5).
Oxo-tridecyl acetate (CAS .............. Solvent
Reg. No. 108419-35-8).
* * * * * * *
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[FR Doc. 96-3018 Filed 2-13-96; 8:45 am]
BILLING CODE 6560-50-F
