[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          
------------------------------------------------------------------------
                                                                        
       *                  *                  *                  *       
                  *                  *                  *               
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