[Federal Register Volume 59, Number 89 (Tuesday, May 10, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-11194]
[[Page Unknown]]
[Federal Register: May 10, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300320A; FRL-4777-5]
RIN 2070-AB78
d-Limonene; Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This document establishes 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 raw agricultural commodities
after harvest, or to animals.
EFFECTIVE DATE: This regulation becomes effective May 10, 1994.
ADDRESSES: Written objections and hearing requests, identified by the
document control number [OPP-300320A], may be submitted to: Hearing
Clerk (1900), Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. A copy of any objections and hearing request
filed with the Hearing Clerk should be identified by the document
control number and submitted to: Public Response and Program Resources
Branch, Field Opearations Division (7506C), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. In person, bring copy of objections and hearing request to:
Rm. 1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202. Fees
accompanying objections shall be labeled ``Tolerance Petition Fees''
and forwarded to: EPA Headquarters Accounting Operations Branch, OPP
(Tolerance Fees), P.O. Box 360277M, Pittsburgh, PA 15251.
FOR FURTHER INFORMATION CONTACT: Tina Levine, Registration Support
Branch, Registration Division (7505W), Environmental Protection Agency,
401 M St., SW., Washington, DC 20460. Office location and telephone
number: 2800 Crystal Dr., 6th Fl., North Tower, Arlington, VA 22202,
(703)-308-8393.
SUPPLEMENTARY INFORMATION: In the Federal Register of February 23, 1994
(59 FR 8581), EPA issued a proposed rule that gave notice that Orange
Sol, Inc., 955 N. Fiesta Blvd., Suite #1, Gilbert, AZ 85234, had
submitted pesticide petition (PP) 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. 5989-275) when used as an
inert ingredient (solvent, fragrance) in pesticide formulations applied
to growing crops only or 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 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.
Two comments were received in response to the proposed rule. One
commenter noted that d-limonene is toxic by ingestion and that, since
most pesticides do not smell like oranges, special labeling should be
used to warn the public about this special hazard. In addition, this
commenter was concerned about potential kidney toxicity of d-limonene
and did not believe that it should be allowed in unlimited amounts in
pesticides, noting that the American Industrial Hygiene Association
(AIHA) had established an 8-hour time-weighted Workplace Environmental
Exposure Level (WEEL) for d-limonene of 30 parts per million, primarily
on the basis of toxicity to the kidney. The commenter also noted that
the Agency should determine whether d-limonene is functioning as an
active ingredient as well, and that if it is functioning as an active
ingredient, it should be registered. The commenter included a fact
sheet on d-limonene which discussed the concerns noted in the response
letter.
The Agency considered the toxicity data on d-limonene before
proposing the exemption from tolerance. The acute toxicity of d-
limonene (LD50 = 4.4 g/kg in rats and 5.6 g/kg in mice) puts it in
the category of moderately to slightly toxic. The commenter noted that
the acute toxicity of d-limonene would require it to be labeled to
prevent ingestion by children under the Hazardous Substances Act. The
Agency uses the same labeling criteria to label products under FIFRA.
All end-use pesticide products are tested for acute toxicity. Labeling
for the product is based upon the results of this testing. If a product
containing d-limonene is acutely toxic, it will be labeled
appropriately.
The Agency also considered the issue of allowing a food fragrance
in a pesticide before developing this exemption. In 1975, a policy was
established in the Registration Division which essentially prohibited
the use of food or food-like fragrances in certain pesticide
formulations (Standards and Labeling Policy Notice No. 2155.1, November
20, 1975). The policy was based on the premise that food or food-like
fragrances in pesticide formulations ``could be attractive to children
and constitute an unwarranted hazard.'' A review of the benefits of
this policy concluded that there are no scientific data which
demonstrate that the addition of a food or food-like fragrance to a
pesticide formulation increases the likelihood of accidental ingestion.
The Consumer Product Safety Commission (CPSC) was also consulted to
determine if they had addressed the effect of food or food-like
fragrances on the exposure incidence of household products for children
under 5 years of age. The CPSC has taken no regulatory action regarding
the additions of such factors to household products because there is no
evidence that the absence of such factors deters accidental ingestions.
Pesticide product epidemiological data from the 1991 Annual Report of
the American Association of Poison Control Centers National Data
Collection System confirm that the absence of food or food-like
fragrances in pesticide products is not effective in preventing/
reducing the exposure incidence to pesticides for children under 5
years of age. Therefore, the Agency rescinded its 1975 policy.
The Agency also discussed the data it considered on kidney toxicity
and tumor formation in the proposed rule. The demonstrated nephropathy
and tumor formation produced by d-limonene has been related to alpha-
2u-globulin accumulation specifically in the male rat. The Agency's
position regarding compounds producing renal tubule tumors (in male
rats) attributable solely to chemically induced alpha-2u-globulin
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. This
position was described in the proposed rule.
AIHA decided to develop a WEEL for d-limonene because of its
widespread use and in order to peer review the positive National
Toxicology Program (NTP) tumor results in male rat kidney. In fact, the
30 ppm, 8-hour time-weighted WEEL developed by the AIHA was not based
on kidney toxicity for the same reason that the Agency has decided not
to use the male rat kidney data. The WEEL value was developed based on
no-observed-effect levels (NOELs) in the 2-year NTP study where liver
effects were noted in male mice at 500 mg/kg and reduced survival was
noted in female rats at 600 mg/kg. The NOELs for these effects were 250
mg/kg and 300 mg/kg, respectively (AIHA, WEEL, d-Limonene, 1993). As
discussed in the proposal, EPA considered these data in concluding that
a tolerance was not necessary to protect the public health.
The Agency agrees with the commenter that when d-limonene functions
as an active ingredient in a product, it should be regulated as such.
The exemption from tolerance for d-limonene applies to its use as an
inert ingredient only. If it is determined that d-limonene is acting as
an active ingredient, it will be regulated as an active ingredient.
The other commenter endorsed the proposed rule and requested that
it be expanded to include the use of d-limonene as an inert ingredient
in pesticide formulations applied to animals. The data submitted in the
proposal and other relevant material have been evaluated and discussed
in the proposed rule. As stated in the proposed rule, the Agency
believes that the data on d-limonene demonstrate low toxicity. For this
reason, the Agency will expand the exemption for d-limonene to include
its use as a fragrance or solvent in pesticide formulations applied to
animals. Based on the data and information considered, the Agency
concludes that the tolerance exemption will protect the public health.
Therefore, the tolerance exemption is established as set forth below.
Any person adversely affected by this regulation may, within 30
days after publication of this document in the Federal Register, file
written objections and/or request a hearing with the Hearing Clerk, at
the address given above (40 CFR 178.20). A copy of the objections and/
or hearing requests filed with the Hearing Clerk should be submitted to
the OPP docket for this rulemaking. The objections submitted must
specify the provisions of the regulation deemed objectionable and the
grounds for the objections (40 CFR 178.25). Each objection must be
accompanied by the fee prescribed by 40 CFR 180.33(i). If a hearing is
requested, the objections must include a statement of the factual
issue(s) on which a hearing is requested, the requestor's contentions
on such issues, and a summary of any evidence relied upon by the
objector (40 CFR 178.27). A request for a hearing will be granted if
the Administrator determines that the material submitted shows the
following: There is a genuine and substantial issue of fact; there is a
reasonable possibility that available evidence identified by the
requestor would, if established, resolve one or more of such issues in
favor of the requestor, taking into account uncontested claims or facts
to the contrary; and resolution of the factual issue(s) in the manner
sought by the requestor would be adequate to justify the action
requested (40 CFR 178.32).
Under Executive Order 12866 (58 FR 51735, Oct. 4, 1993) the Agency
must determine whether the regulatory action is ``significant'' and
therefore subject to review by the Office of Management and Budget
(OMB) and the requirements of the Executive Order. Under section 3(f),
the order defines a ``significant regulatory action'' as an action that
is likely to result in a rule (1) having an annual effect on the
economy of $100 million or more, or adversely and materially affecting
a sector of the economy, productivity, competition, jobs, the
environment, public health or safety, or State, local, or tribal
governments or communities (also referred to as ``economically
significant''); (2) creating serious inconsistency or otherwise
interfering with an action taken or planned by another agency; (3)
materially altering the budgetary impacts of entitlement, grants, user
fees, or loan programs or the rights and obligations or recipients
thereof; or (4) raising novel legal or policy issues arising out of
legal mandates, the President's priorities, or the principles set forth
in this Executive order. Pursuant to the terms of the Executive Order,
EPA has determined that this rule is not ``significant'' and is
therefore not subject to OMB review.
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: April 26, 1994.
Douglas D. Campt,
Director, Office of Pesticide Programs.
Therefore, 40 CFR part 180 is 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) 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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* * * * *
(e) * * *
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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. 94-11194 Filed 5-9-94; 8:45 am]
BILLING CODE 6560-50-F
