[Federal Register Volume 59, Number 36 (Wednesday, February 23, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-3760]
[[Page Unknown]]
[Federal Register: February 23, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300320; FRL-4754-6]
RIN 2070-AC18
d-Limonene; Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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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:
Sec. 180.1001 Exemptions from the requirement of a tolerance.
* * * * *
(c) * * *
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Inert ingredients Limits Uses
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d-Limonene (CAS Reg. No. .................. Solvent, fragrance
5989-27-5).
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* * * * *
[FR Doc. 94-3760 Filed 2-22-94; 8:45 am]
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