[Federal Register Volume 59, Number 159 (Thursday, August 18, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-20326]
[[Page Unknown]]
[Federal Register: August 18, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300354; FRL-4904-8]
RIN 2070-AC18
Methyl-1-Alkylamido Ethyl-2-Alkyl-2-Imidazolinium Methyl Sulfate;
Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: This document proposes that methyl-1-alkylamido ethyl-2-alkyl-
imidazolinium methyl sulfate, where the alkyl group (C8-C18)
is derived from coconut, cottonseed, soya, tallow, or hogfat fatty
acids, be exempted from the requirement of a tolerance when used as an
inert ingredient (metal corrosion inhibitor, spreader-sticker) in
propionic acid formulations applied to various grains, grasses, and
hays. This proposed regulation was requested by the Witco Corp.
DATES: Comments, identified by the document control number [OPP-
300354], must be received on or before September 19, 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. 1132, Crystal
Mall, Bldg. #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: Tina Levine, 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)-308-8393.
SUPPLEMENTARY INFORMATION: The Witco Corp., 3200 Brookfield St.,
Houston, TX 77045, has submitted pesticide petition (PP) 2E4123 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 methyl-1-alkylamido ethyl-2-alkyl-
imidazolinium methyl sulfate, where the alkyl group (C8-C18)
is derived from coconut, cottonseed, soya, tallow, or hogfat fatty
acids, when used as an inert ingredient (metal corrosion inhibitor,
spreader-sticker) in propionic acid formulations applied to various
grains, grasses and hays, as specified in 40 CFR 180.1023.
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 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 methyl-2-alkylamido
ethyl-2-alkyl-imidazolinium methyl sulfate will need to be submitted.
The rationale for this decision is described below:
1. A 90-day feeding study in rats resulted in a no-observed-effect
level (NOEL) of 100 mg/kg/day and a lowest-observed-effect level (LOEL)
of 1,000 mg/kg/day based upon a decreased liver to body weight ratio.
There were no other effects and no liver histopathology.
2. A 90-day feeding study in dogs showed a decrease in cholesterol
values at dose levels greater than 4,000 ppm. However, this effect was
considered an artifact of decreased food consumption. Therefore, the
NOEL for systemic toxicity in this study is considered to be greater
than 12,000 ppm (366 and 632 mg/kg/day for males and females,
respectively.
3. A rat developmental toxicity study indicates a NOEL of 300 mg/
kg/day and a LOEL of 1,000 mg/kg/day. However, at the LOEL there was
only a very slight increase in the total number of litters with any
kind of malformation (14% in control and 20% in the 1,000 mg/kg/day
dose group) and no significant increase in the incidences of individual
malformations. Thus, the true NOEL appears to lie closer to 1,000 mg/
kg/day.
Based upon the above information and review of its use, EPA has
found that, when used in accordance with good agricultural practice,
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-300354]. 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 12291.
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: August 9, 1994.
Lois Rossi,
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. In subpart D, by adding new Sec. 180.1133, to read as follows:
Sec. 180.1133 Methyl-1-alkylamido ethyl-2-alkyl-imidazolinium methyl
sulfate; exemption from the requirement of a tolerance.
Methyl-1-alkylamido ethyl-2-alkyl-imidazolinium methyl sulfate,
where the alkyl group (C8-C18) is derived from coconut,
cottonseed, soya, tallow, or hogfat fatty acids, is exempted from the
requirement of a tolerance when used as an inert ingredient (metal
corrosion inhibitor, spreader-sticker) in propionic acid formulations
applied to various grains, grasses, and hays, as specified in 40 CFR
180.1023.
[FR Doc. 94-20326 Filed 8-17-94; 8:45 am]
BILLING CODE 6560-50-F
