[Federal Register Volume 60, Number 21 (Wednesday, February 1, 1995)]
[Proposed Rules]
[Pages 6052-6054]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-2442]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300376; FRL-4928-4]
RIN 2070-AC18
Isopropyl Myristate; Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: This document proposes that isopropyl myristate be exempted
from the requirement of a tolerance when used as a solvent in pesticide
formulations. Technology Sciences Group, Inc., on behalf of Sumitomo
Chemical Co., Ltd., requested this proposed rule.
DATES: Comments, identified by the document control number, [OPP-
300376], must be received on or before March 3, 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 #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.
SUPPLEMENTARY INFORMATION: Technology Sciences Group, Inc., Pesticide
Division, Steuart Street Tower 2700, One Market Plaza, San Francisco,
CA 94105-1475, submitted pesticide petition (PP) 3E04245 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) and (e) by establishing exemptions from the
requirement of a tolerance for isopropyl myristate when used as a
solvent in pesticide formulations applied to growing crops, raw
agricultural commodities, and animals.
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 [[Page 6053]] 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 isopropyl myristate will
need to be submitted. The rationale for this decision is described
below:
1. An acute oral toxicity study with an acute oral LD50 of
greater than 42,400 mg/kg in mice and 14,000 mg/kg in rats.
2. The intraperitoneal acute toxicity studies with LD50 of
greater than 67,800 mg/kg in rats and greater than 42,800 mg/kg in
mice.
3. An acute dermal study with LD50 of greater than 67,829 mg/
kg in rats and greater than 5,000 mg/kg in rabbits.
4. A rabbit primary eye irritation study using isopropyl myristate
produced minimal irritation and cleared within 7 days.
5. A rabbit primary dermal irritation study showing minimal
irritation.
6. A guinea pig dermal sensitization study producing no evidence of
dermal sensitization.
7. A rat acute inhalation toxicity study with LC50 greater
than 33-41 mg/liter in rats indicating that isopropyl myristate is of
minimal concern.
8. A 4-week rabbit dermal subchronic study with applications of 16
to 47 percent isopropyl myristate in rabbits at 1,700 and 2,000 mg/kg
did not produce any systemic toxicity.
9. A 12-week intramascular injection of 25 percent isopropyl
myristate at 256 mg/kg in rats, 119 mg/kg in dogs, and 128-282 mg/kg in
monkeys produced minor local skin effects and no systemic toxicity
effects.
10. A 13-week inhalation study using 16 to 20 percent isopropyl
myristate showed lung enlargements in guinea pigs at 224 mg/m3 and
monkeys at 5.3 to 37 mg/m3.
11. Rabbit and mice dermal carcinogenicity studies showed that
isopropyl myristate is not carcinogenic when applied chronically on the
skin of mice at 3.4 mg/kg for 18 months and for 110 weeks and on
rabbits at 68, 340, and 680 mg/kg for 160 weeks. A mixture of isopropyl
myristate and isopropyl alcohol accelerated the carcinogenic activity
of benzo-pyrene when applied on the skin of mice.
12. A metabolism study showed that isopropyl myristate is
hydrolyzed to normal metabolic products, namely isopropyl alcohol and
myristic acid.
13. Isopropyl myristate Ames Assay produced a negative result.
The Agency does not have data from two subchronic developmental
toxicity and two mutagenicity studies which are part of the toxicology
data typically required to be submitted in support of a tolerance
exemption request. However, based upon isopropyl myristate's lack of
carcinogenicity, mutagenicity (Ames Test) and low acute toxicity from
oral, dermal, inhalation, or parenteral toxicity studies, the Agency
does not believe that isopropyl myristate poses significant risks under
the proposed conditions of use. No further studies are required. In
addition, isopropyl myristate is likely metabolized to isopropyl
alcohol, which is exempt from tolerance requirements under 40 CFR
180.1001 (c), (d), and (e), and myristic acid, which is an edible fatty
acid.
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-300376]. 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, 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 23, 1995.
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. Section 180.1001 is amended in paragraphs (c) and (e) in the
tables therein by adding and alphabetically inserting the inert
ingredient, to read as follows:
Sec. 180.1001 Exemptions from the requirement of a tolerance.
* * * * *
(c) * * *
[[Page 6054]]
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Inert ingredients Limits Uses
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Isopropyl myristate, CAS ................ Solvent
Reg. No. 110-27-0.
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(e) * * *
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Inert ingredients Limits Uses
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* * * *
* * *
Isopropyl myristate, CAS ................ Solvent
Reg. No. 110-27-0.
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[FR Doc. 95-2442 Filed 1-31-95; 8:45 am]
BILLING CODE 6560-50-F