[Federal Register Volume 69, Number 82 (Wednesday, April 28, 2004)]
[Rules and Regulations]
[Pages 23142-23146]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-9618]


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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: [email protected].

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 [email protected], 
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: [email protected]. 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