[Federal Register: April 28, 2004 (Volume 69, Number 82)]
[Rules and Regulations]
[Page 23146-23151]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28ap04-13]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2004-0068; FRL-7351-1]
Geraniol; 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 geraniol 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 geraniol.
DATES: This regulation is effective April 28, 2004. Objections and
requests for hearings, identified by docket ID number OPP-2004-0068,
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
[[Page 23147]]
docket for this action under Docket ID number OPP-2004-0068. 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., 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)
Food manufacturing (NAICS 311)
Pesticide manufacturing (NAICS 32532)
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.
B. How Can I Get Copies of this Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under docket identification (ID) number OPP-2004-0068. The
official public docket consists of the documents specifically
referenced in this action, any public comments received, and other
information related to this action. Although a part of the official
docket, the public docket does not include Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. The official public docket is the collection of materials
that is available for public viewing 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.
2. Electronic access. 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/, a beta site currently under
development. The OPPTS harmonized test guidelines referenced in this
document are available at http://www.epa. gov/opptsfrs/ home/
guidelin.htm/.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Once in the system, select ``search,''
then key in the appropriate docket ID number.
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 (PP 0F6073) 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 geraniol. 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.
Geraniol is a monoterpene alcohol found in over 250 essential oils,
and is widely used as a fragrance component in the manufacture of
detergents, soaps, creams, lotions, cosmetics, and aromatherapy
products. This chemical is also used as a synthetic flavoring agent in
beverages, ice cream, and candies, and is generally regarded as safe
(GRAS) under section 409 of the FFDCA (21 CFR 182.60). The toxicity
[[Page 23148]]
studies submitted in support of this tolerance exemption are referenced
below.
1. Acute oral toxicity (OPPTS 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, geraniol, at
0.42% of the product. The pesticide was tested at doses ranging from
2,500 to 5,500 mg/kg of body weight and observed for 14 days. The oral
LD50 for males and females were 5,242 mg/kg and 3573 mg/kg,
respectively. Classification: Acceptable. Toxicity Category III, based
on the LD50 of female Sprague-Dawley rats.
2. Acute dermal toxicity (OPPTS 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, geraniol, at 0.42%
of the product, and observed for 14 days. Classification: Acceptable.
Toxicity Category: IV.
3. Acute inhalation toxicity (OPPTS 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 geraniol 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 870.2400; 152-13; MRID 45262006).
An acute eye irritation study was conducted in male and female albino
New Zealand white rabbits using a a pesticide product containing an
active ingredient, geraniol, 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 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, geraniol, 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 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, geraniol, 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 the required studies
on the technical grade of the active ingredient 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 geraniol in
nature; the long history of use in cosmetics, fragrances, detergents,
and household cleaners; the natural occurrence in fruits and beverages;
the wide 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 geraniol (0.42%) in the pesticide product. In
addition, data on the toxicity of geraniol 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 (severe in humans), dermal sensitization (weak senistizaer,
variable response, species not indicated), subchronic oral toxicity in
the rat (no effects at 10,000 ppm in the diet for 16 weeks, no effects
at 1,000 ppm for 26 weeks), and mutagenicity/genotoxicity (negative in
the Ames assay in Salmonella typhimurium strains tested at 100 [mu]g).
Data for geranyl acetate (and other esters of geranyl), which is used
as a flavoring agent and is readily hydrolyzed to geraniol in the
intestines of mammals, were also submitted. This data demonstrated an
acute oral Toxicity category IV; no adverse effects at 1,000 mg/kg/day
fo r 14 days and 13 weeks in mice, and no adverse effects in a chronic
dietary/carcinogenicity study in rats fed 1,000 mg/kg/day for 103
weeks. Further, according to the World Health Organizations (WHO),
dietary intake of geraniol is estimated based on the quantity of
geranyl acetate conumed in the diet (Food Additives Series 40; 49\th\
meeting of the Joint FAO/WHO Expert Committee on Food Additives
(JEFCA), 1998). Based on the data from the pesticide product submitted,
the Agency, the data on geraniol from the public literature, and the
data from geranyl acetate, the no adverse effects to humans would be
anticipated via acute, subchronic, or chronic dietary exposures to
geranyl acetate, particularly at the low levels of geraniol 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 geraniol primarily from the consumption of fruits,
beverages, food seasonings and its 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
greenhouse 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. Geraniol 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 only 0.42%. The product is not intended for
aquatic uses. Geraniol is insoluble in water and biodegrades rapidly in
the soil, precluding its entry into ground and/or surface waters.
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.
[[Page 23149]]
B. Other Non-Occupational Exposure
1. Dermal exposure. Non-occupational dermal exposures to geraniol
from its pesticidal use are expected to be minimal to non-existent.
Human dermal exposures to geraniol occur primarily from its use as a
fragrance in cosmetics, soaps, detergents, creams, and lotions, not
from the agricultural use as a pesticide.
2. Inhalation exposure. Non-occupational inhalation exposures to
geraniol from its pesticidal use are expected to be minimal to non-
existent. The main sources of human exposure to geraniol by this route
are from its use as a fragrance in cosmetics, soaps, detergents, creams
and lotions.
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 geraniol 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, geraniol 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 geraniol has a
common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanisms 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 geraniol 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 geraniol and the widespread use of
geraniol in the human diet, cosmetics and fragrances found in a variety
of food products and beverages, and that geraniol 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. Section 408 of the FFDCA provides that EPA
shall apply an additional tenfold margin of exposure for infants and
children in the case of threshold effects. Margins of exposure are
often referred to as uncertainty or safety factors, and are used to
account for potential prenatal and postnatal toxicity and any lack of
completeness of the data base Based on available data and other
information, EPA may determine that a different margin of exposure will
be safe for infants and children or that a margin of exposure approach
is not appropriate. Based on all the available information the Agency
reviewed on geraniol, including a lack of threshold effects, the Agency
concluded that geraniol is practically non-toxic to mammals, including
infants and children. Since there are no effects of concern, the
provision requiring 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 geraniol. It is naturally occurring
and a food additive in a variety of food products, and is widely used
as a fragrance in the cosmetic industry. In addition, there is no
evidence to suggest that geraniol 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 geraniol low toxicity. For the same reasons, the
Agency concludes that an analytical method is not required for
enforcement purposes for geraniol.
C. Codex Maximum Residue Level
There are no codex maximum residue levels established for residues
of geraniol.
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. The 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-2004-0068 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
[[Page 23150]]
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-2004-0068, 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
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.
[[Page 23151]]
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 record
keeping 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 180.1251 is added to subpart D to read as follows:
Sec. 180.1251 Geraniol; exemption from the requirement of a
tolerance.
An exemption from the requirement of a tolerance is established for
residues of the biochemical pesticide geraniol in or on all food
commodities.
[FR Doc. 04-9577 Filed 4-27-04; 8:45 am]
BILLING CODE 6560-50-S