[Federal Register: April 28, 2004 (Volume 69, Number 82)]
[Rules and Regulations]
[Page 23142-23146]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28ap04-12]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2004-0067; FRL-7351-6]
Citronellol; Exemption from the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of the citronellol on all food commodity
when applied/used to control Tetranychid mites. Natural Plant
Protection S.A. submitted a petition to EPA under the Federal Food,
Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality
Protection Act of 1996 (FQPA), requesting an exemption from the
requirement of a tolerance. This regulation eliminates the need to
establish a maximum permissible level for residues of citronellol.
DATES: This regulation is effective April 28, 2004. Objections and
requests for hearings, identified by docket ID number OPP-2004-0067,
must be received on or before June 28, 2004.
ADDRESSES: To submit a written objection or hearing request follow the
detailed instructions as provided in Unit VIII. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under docket
ID number OPP-2004-0067. All documents in the docket are listed in the
EDOCKET index at http://www.epa.gov/edocket/. Although listed in the
index, some information is not publicly available, i.e., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically in EDOCKET or in hard copy at the
Public Information and Records Integrity Branch (PIRIB), Rm. 119,
Crystal Mall 2, 1921 Jefferson Davis Hwy., Arlington, VA. This
docket facility is open from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The docket telephone number is (703)
305-5805.
FOR FURTHER INFORMATION CONTACT: Raderrio Wilkins, Biopesticides and
Pollution Prevention Division (7511C), Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-1259; e-mail address: Wilkins.Raderrio@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS 111)
Animal production (NAICS 112)
Pesticide manufacturing (NAICS 32532)
Food manufacturing (NAICS 311)
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
[[Page 23143]]
B. How Can I Access Electronic Copies of this Document and Other
Related Information?
In addition to using EDOCKET (http://www.epa.gov/edocket/), you may
access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/.
A frequently updated electronic version of 40 CFR part 180
is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.
II. Background and Statutory Findings
In the Federal Register of May 23, 2000 (65 FR 33318) (FRL-6557-1),
EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (0F6145) by Natural Plant Protection S.A., 4061 North
156th Drive, Goodyear, AZ 85338. This notice included a
summary of the petition prepared by the petitioner Natural Plant
Protection S.A.There were no comments received in response to the
notice of filing.
The petition requested that 40 CFR part 180 be amended by
establishing a temporary exemption from the requirement of a tolerance
for residues of citronellol.
Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of the FFDCA
defines ``safe'' to mean that ``there is a reasonable certainty that no
harm will result from aggregate exposure to the pesticide chemical
residue, including all anticipated dietary exposures and all other
exposures for which there is reliable information.'' This includes
exposure through drinking water and in residential settings, but does
not include occupational exposure. Pursuant to section 408(c)(2)(B), in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
section 408(b)(2)(C), which require EPA to give special consideration
to exposure of infants and children to the pesticide chemical residue
in establishing a tolerance and to ``ensure that there is a reasonable
certainty that no harm will result to infants and children from
aggregate exposure to the pesticide chemical residue. . . .''
Additionally, section 408(b)(2)(D) of the FFDCA requires that the
Agency consider ``available information concerning the cumulative
effects of a particular pesticide's residues'' and ``other substances
that have a common mechanism of toxicity.''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.
III. Toxicological Profile
Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed
the available scientific data and other relevant information in support
of this action and considered its validity, completeness, and
reliability and the relationship of this information to human risk. EPA
has also considered available information concerning the variability of
the sensitivities of major identifiable subgroups of consumers,
including infants and children.
Citronellol is a monoterpene alcohol found in over 30 essential
oils, and is widely used as a fragrance component in the manufacture of
perfumes, cosmetics, detergents and household cleaners. It is a
naturally occurring substance in black currants, certain other fruits,
wines, beer, and black tea. This chemical is also used as a synthetic
flavoring agent in alcoholic and non-alcoholic beverages, and as a
spice. Citronellol is generally regarded as safe (GRAS) under section
409 of FFDCA (21 CFR 172.515) as a synthetic flavoring agent and
adjuvant which is permitted to be added directly to food for human
consumption. It is also contained in approximately 25 essential oils,
oleoresins and plant extracts that are GRAS under section 409 of FFDCA
(21 CFR 182.20). The toxicity studies submitted in support of this
tolerance exemption are referenced below.
1. Acute oral toxicity (OPPTS Harmonized Guideline 870.1100; 152-
10; MRID 45262003). Male and female Sprague-Dawley rats were tested
with a single exposure to a pesticide product containing an active
ingredient, citronellol, at 0.42% of the product. The pesticide was
tested at doses ranging from 2,500 to 5,500 milligrams/kilogram/body
weight (mg/kg/bwt) and observed for 14 days. The oral lethal dose
(LD)50 for males and females were 5,242 mg/kg and 3,573 mg/
kg, respectively. Classification: Acceptable. Toxicity Category III,
based on the LD50 of female Sprague-Dawley rats.
2. Acute dermal toxicity (OPPTS Harmonized Guideline 870.1200; 152-
11; MRID 45262004). Male and female New Zealand white rabbits were
given 5,050 mg/kg of a pesticide product containing an active
ingredient, citronellol, at 0.42% of the product, and observed for 14
days. Classification: Acceptable. Toxicity Category: IV.
3. Acute inhalation toxicity (OPPTS Harmonized Guideline 870.1300;
152-12; MRID 45262005). Male and female Sprague-Dawley rats were
exposed for 4 hours to an atomospheric concentration of 2.64 mg/L of a
pesticide product containing citronellol as an active ingredient and
observed for 14 days. The acute inhalation LC50 was > 2.64
mg/L. Classification: Acceptable. Toxicity Category: IV.
4. Primary eye irritation (OPPTS Harmonized Guideline 870.2400;
152-13; MRID 45262006). An acute eye irritation study was conducted in
male and female albino New Zealand white rabbits using a pesticide
product containing an active ingredient, citronellol, at 0.42% of the
product. The test substance was moderately irritating to the eyes of
the test animals, causing corneal opacitiy (cloudiness) and
conjunctivitis (redness) that cleared within 10 days following this
exposure. Classification: Acceptable. Toxicity: Category II.
5. Primary dermal irritation (OPPTS Harmonized Guideline 870.2500;
152-14; MRID 45262007). The shaved skin of male and female New Zealand
White rabbits was exposed to a single 0.5 mL dose of a pesticide
product containing the active ingredient, citronellol, at 0.42% of the
product. for 4 hours and observed for 14 days for signs of skin
irritation. The test substance was moderately irritating to the skin of
the test animals, causing very slight to well-defined erythema (skin
redness) that cleared within 14 days following exposure.
Classification: Acceptable. Toxicity Category: III.
6. Hypersensitivity (OPPTS Harmonized Guideline 870.2500; 152-15;
MRID 45262008). The shaved skin of male and female Hartley guinea pigs
was treated once weekly for 3 weeks with a pesticide product containing
the active ingredient, citronellol, at 0.42% of the product. Skin
redness (irritation) followed each treatment cleared within 48 hours. A
challenge dose was given to an untreated site, and the animals observed
for signs of allergic reaction (hypersensitiity) to the test material.
The treated test and naive control animals showed no allergenicity
(swelling, redness) at 24 and 48 hours after this challenge dose. The
pesticide product was not a dermal sensitizer in Hartley guinea pigs.
Classification: Acceptable.
The pesticide registrant requested waivers of required studies on
the technical grade of the active ingredient
[[Page 23144]]
for acute toxicity, genotoxicity, reproductive toxicity, developmental
toxicity, subchronic toxicity in mammalian species, and acute toxicity
to non-target species. The waivers were based on the ubiquity of
citronellol in nature; the long history of its use in cosmetics,
fragrances, detergents, and household cleaners; the natural occurrence
in fruits and beverages; the widespread use as a synthetic flavoring
agent and adjuvant; and the low anticipated exposure to humans and the
environment due to the very low concentration of citronellol in the
pesticide product. In addition, data on the toxicity of citronellol
from publicly available technical literature was presented to the
Agency (MRID 452620-10) for acute oral toxicity in the rat (Toxicity
Category III), acute dermal toxicity (Toxicity Category IV, no species
indicated), dermal irritation (moderate in humans), and mutagenicity/
genotoxicity (negative in Ames assay in three Salmonella typhimurium
strains tested at 100 g). Toxicity data were also submitted for
citronellyl acetate (and other esters of citronellol), which is widely
used as a flavoring agent. According to the World Health Organization
(WHO), dietary intake of citronellol is estimated, based on the
quantity of citronellyl acetate consumed in the diet (Food Additives
Series 40; 49th meeting of the Joint FAO/WHO Expert Committee on Food
Additives (JEFCA), 1998). The rationale for the use of citronellyl
acetate toxicity data to estimate the dietary toxicity of citronellol
is based on data demonstrating that citronellyl acetate is readily
hydrolyzed to citronellol in the intestines of mammals, and that
citronellol is further metabolized to non-toxic, polar compounds that
are excreted in the urine (JEFCA 1998). Data obtained from toxicity
studies using citronellyl acetate as the test substance demonstrated an
acute oral Toxicity Category IV in rat; no adverse effects with an oral
dose of 290 mg/kg/day for 14 days and 13 weeks in mice, and no adverse
effects in a chronic dietary/carcinogenicity study in rats fed 290 mg/
kg/day for 103 weeks. Further, based on the data submitted by the
registrant for the pesticide product, data on citronellol from the
public literature, and the data on citronellyl acetate form the public
literature, the no adverse effects to humans would be anticipated via
acute, subchronic, or chronic dietary exposures to citronellol,
particularly at the low levels of citronellol in the pesticide product
under consideration for registration by the Agency.
IV. Aggregate Exposures
In examining aggregate exposure, section 408 of the FFDCA directs
EPA to consider available information concerning exposures from the
pesticide residue in food and all other non-occupational exposures,
including drinking water from ground water or surface water and
exposure through pesticide use in gardens, lawns, or buildings
(residential and other indoor uses).
A. Dietary Exposure
1. Food. Dietary exposure is expected to occur for most, if not all
individuals to citronellol primarily from the consumption of fruits,
beverages, food seasonings and use as a flavoring agent/adjuvant in a
wide variety of foods. The end-use product contains a low concentration
of citronellol (0.42%) which is further reduced by dilution with water
(no less than approximately 1:156 v/v) prior to application. Based on
the extremely low application rate required to achieve the desired
pesticidal effects, the Agency concluded that dietary exposure
resulting from the proposed use on agricultural and green house crops
will be minimal and lower than levels of citronellol currently consumed
in foods where it is naturally occurring and/or present as a food
additive.
2. Drinking water exposure. Citronellol residues in drinking water
are expected to be minimal from its use as a pesticide. The pesticide
product has a low use rate and the concentration of citronellol in the
pesticide product is 0.42%. The product is not intended for aquatic
use. Citronellol is insoluble in water and biodegrades rapidly in the
soil, precluding its entry into the ground water and/or surface water.
Therefore, the Agency has concluded that it is highly unlikely that any
residues resulting from the pesticidal use of citronellol would migrate
into drinking water from natural sources.
B. Other Non-Occupational Exposure
1. Dermal exposure. Non-occupational dermal exposures to
citronellol from its pesticidal use are expected to be minimal to non-
existent. Human dermal exposures to citronellol occur primarily from
its use as a fragrance in cosmetics, soaps, detergents, creams,
lotions, and dermallyapplied insect repellents, not from an
agricultural use as a pesticide.
2. Inhalation exposure. Non-occupational inhalation exposures to
citronellol from its pesticidal use are expected to be minimal to non-
existent. The main sources of human exposure to citronellol by this
route are from its use as a fragrance in cosmetics, soaps, detergents,
creams, lotions, and dermally applied insect repellents.
V. Cumulative Effects
Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider the ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA does not have, at this time, available data to determine
whether citronellol has a common mechanism of toxicity with any other
substances. It's mode of action is as a repellent, which is considered
by the Agency as a non-toxic mode of action on target pest species.
Further, citronellol does not appear to produce a toxic metabolite
produced by other substances. Therefore, for the purpose of this
tolerance exemption action, EPA has not assumed that citronellol has a
common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see the policy statements released by EPA's Office of
Pesticide Programs concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a
common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/
.
VI. Determination of Safety for U.S. Population, Infants and Children
1. U.S. population. The Agency has determined that there is
reasonable certainty that no harm will result from aggregate exposure
to residues of citronellol to the U.S. population. This includes all
anticipated dietary exposures and other exposures for which there is
reliable information. The Agency arrived at this conclusion based on
the anticipated low acute exposure estimates from its pesticidal use,
the low mammalian toxicity of citronellol, the widespread use of
citronellol in the human diet, cosmetics, and fragrances found in a
variety of food products and beverages, and in insect repellents, and
that citronellol is considered GRAS under 21 CFR 172.515 as a synthetic
flavoring and adjuvant permitted to be added directly to food for human
consumption.
2. Infants and children. FFDCA section 408 provides that EPA shall
apply an additional tenfold margin of
[[Page 23145]]
exposure for infants and children in the case of threshold effects. In
this instance, based on all the available information, including a lack
of threshold effects, the Agency concluded that citronellol is
practically non-toxic to mammals, including infants and children. Since
there are no effects of concern, the application of an additional
margin of safety does not apply.
VII. Other Considerations
A. Endocrine Disruptors
Based on available data, no endocrine system-related effects have
been identified with consumption of citronellol. It is a naturally
occurring substance and a food additive in a variety of food products,
is widely used as a fragrance in the cosmetic industry, and is a
component of several dermally applied insect repellents. In addition,
there is no evidence to suggest that citronellol affects the immune
system's function in any manner.
B. Analytical Method(s)
The Agency proposed to establish an exemption from the requirement
of a tolerance without any numerical limitation for the reasons stated
above, including citronellol's low toxicity. For the same reasons, the
Agency concludes that an analytical method is not required for
enforcement purposes for citronellol.
C. Codex Maximum Residue Level
There are no codex maximum residue levels established for residues
of citronellol.
VIII. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. EPA procedural regulations
which govern the submission of objections and requests for hearings
appear in 40 CFR part 178. Although the procedures in those regulations
require some modification to reflect the amendments made to the FFDCA
by the FQPA, EPA will continue to use those procedures, with
appropriate adjustments, until the necessary modifications can be made.
The new section 408(g) of the FFDCA provides essentially the same
process for persons to ``object'' to a regulation for an exemption from
the requirement of a tolerance issued by EPA under new section 408(d)
of the FFDCA, as was provided in the old sections 408 and 409 of the
FFDCA. However, the period for filing objections is now 60 days, rather
than 30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number OPP-2004-0067 in the subject line on the
first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before June 28,
2004.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(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).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information 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.
Mail your written request to: Office of the Hearing Clerk (1900C),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Rm. 104, Crystal Mall 2, 1921
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Office of the Hearing Clerk is
(703) 603-0061.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VIII.A.,
you should also send a copy of your request to the PIRIB for its
inclusion in the official record that is described in ADDRESSES. Mail
your copies, identified by docket ID number OPP-2004-0067, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the
PIRIB described in ADDRESSES. You may also send an electronic copy of
your request via e-mail to: opp-docket@epa.gov. Please use an ASCII
file format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
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 issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
IX. Statutory and Executive Order Reviews
This final rule establishes an exemption from the tolerance
[[Page 23146]]
requirement on all food commodities under section 408(d) of the FFDCA
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does
not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under section 408(d) of the FFDCA, such as the exemption in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications '' is defined in the Executive Order to include
regulations that have ``substantial direct effects on the States, on
the relationship between the national government and the States, or on
the distribution of power and responsibilities among the various levels
of government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of the FFDCA. For these same reasons, the Agency
has determined that this rule does not have any``tribal implications''
as described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
Order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.
X. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: April 19, 2004.
James Jones,
Director, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.1248 is added to subpart D to read as follows:
Sec. 180.1248 Exemption of citronellol from the requirement of a
tolerance.
An exemption from the requirement of a tolerance is established for
residues of the biochemical pesticide citronellol in or on all food
commodities.
[FR Doc. 04-9618 Filed 4-27-04; 8:45 am]
BILLING CODE 6560-50-S