[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