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d-Limonene - Tolerance Exemption 4/94

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. 5989-27-5)...  .......................  Solvent, fragrance.

               *              *              *              *              *              *

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*     *     *     *     *

   (e) * * *

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           Inert ingredients                     Limits                           Uses

---------------------------------------------------------------------------------------------------------

               *              *              *              *              *              *

d-Limonene (CAS Reg. No. 5989-27-5)...  .......................  Solvent, fragrance.

               *              *              *              *              *              *

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[FR Doc. 94-11194 Filed 5-9-94; 8:45 am]