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d-Limonene - Proposed Tolerance Exemption 2/94

40 CFR Part 180

[OPP-300320; FRL-4754-6]

RIN 2070-AC18

d-Limonene; Tolerance Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

------------------------------------------------------------
SUMMARY: This document proposes that an exemption from the requirement
of a tolerance be established for residues of d-limonene (CAS
Registry No. 5989-27-5) when used as an inert ingredient (solvent,
fragrance) in pesticide formulations applied to growing crops
or raw agricultural commodities after harvest. This proposed
regulation was requested by Orange Sol, Inc.

DATES: Written comments, identified by the document control
number [OPP-300320], must be received on or before March 25,
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, bring comments
to: Rm. 1128, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA
22202.

   Information submitted as a comment concerning this document
may be claimed confidential by marking any part or 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 may be
disclosed publicly by EPA without prior notice. All written
comments will be available for public inspection in Rm. 1128
at the Virginia address given above, from 8 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: By mail: Connie Welch, Registration
Support Branch, Registration Division (7505W), Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. Office
location and telephone number: 2800 Crystal Drive, North Tower,
Arlington, VA 22202, (703)-308-8320.

SUPPLEMENTARY INFORMATION: Orange Sol, Inc., 955 N. Fiesta Blvd.,
Ste. #1, Gilbert, AZ 85234, submitted pesticide petition (PP)
number 3E4172, requesting that the Administrator, pursuant to
section 408(e) of the Federal Food, Drug, and Cosmetic Act,
21 U.S.C. 346a(e), amend 40 CFR 180.1001(c) by establishing
an exemption from the requirement of a tolerance for residues
of d-limonene (CAS Registry No. 5989-27-5) when used as an inert
ingredient (solvent, fragrance) in pesticide formulations applied
to growing crops or to raw agricultural commodities after harvest.

   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 diatomacous
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.
Where it can be determined that the inert ingredient will present
minimal or no risk, the Agency generally does not need 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 any data, in addition
to that described below, for d-limonene will not need to be
submitted. The rationale for this decision is described below:
   1. d-Limonene is a naturally occurring chemical found in
high concentrations in citrus fruits and spices.
   2. d-Limonene is widely used as a fragrance in products such
as perfumes and soaps.
   3. The probable lethal dose of 3-limonene is estimated at
1 pint.
   4. d-Limonene has been administered orally to successfully
dissolve gall stones with no toxic effects observed after ingesting
1 fluid ounce.
   5. A battery of mutagenicity tests conducted on d-limonene
resulted in no positive effects.
   6. A teratogenicity study in which pregnant rats were fed
d-limonene (20 grams per kilogram) during gestation days 6 to
15 yielded results "not considered teratogenic."
   7. In a 2-year feeding study conducted by the National Toxicology
Program, no carcinogenic activity was noted in female rats and
mice and in male mice. Clear evidence of kidney-associated carcinogenic
activity was noted in male rats. However, the NTP has concluded
that the male rat kidney carcinogenicity is not predictive of
mammalian carcinogenicity. Also, the Agency's position regarding
compounds producing renal tubule tumors in male rats attributable
solely to chemically induced alpha-2u-globuylin accumulation
is that these tumors will not be used for human cancer hazard
identification and that the associated nephropathy is not an
appropriate endpoint for determining noncancer risks in humans.
   8. d-,l-, and dl-Limone are generally regarded as safe by
the Food and Drug Administration when used as direct food additives
(synthetic flavoring substance, adjuvant) under 21 CFR 182.60.
The results of the NTP Bioassay did not change its GRAS status.
   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. Because of the low toxicity of this chemical,
the Agency will consider expanding this exemption to include
additional uses.
   Any person who has registered or submitted an application
for registration of a pesticide under the Federal Insecticide,
Fungicide, and Rodenticide Act, as amended, which contains this
chemical 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-300320]. All written comments
filed in response to this document will be available for public
inspection in the Public Response and Program Resources Branch,
at the Virginia 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 2 of Executive Order 12866.
   Pursuant to the requirements of the Regulatory Flexibility
Act of 1980 (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, Reporting and
recordkeeping requirements.

Dated: February 2, 1994.

Stephen L. Johnson,
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(c) is amended by adding and alphabetically
inserting the inert ingredient, to read as follows:

 180.1001   Exemptions from the requirement of a tolerance.
*     *     *     *     *
   (c) * * *

---------------------------------------+-------------------------+------------
------------------------------
           Inert ingredients           |          Limits         |
Uses
---------------------------------------+-------------------------+------------
------------------------------
                                       |                         |
                                       |                         |
               *              *              *              *              *
*              *
d-Limonene (CAS Reg. No. 5989-27-5)...   .......................   Solvent,
fragrance

               *              *              *              *              *
*              *
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[FR Doc. 94-3760 Filed 2-22-94; 8:45 am]