[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) *  *  *

------------------------------------------------------------------------
    Inert ingredients            Limits                   Uses          
------------------------------------------------------------------------
                                                                        
                                 *******                                
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]
BILLING CODE 6560-50-F