[Federal Register: September 13, 2006 (Volume 71, Number 177)]
[Rules and Regulations]
[Page 53984-53989]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13se06-11]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2005-0071; FRL-8080-9]
Epoxiconazole; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
epoxiconazole in or on bananas and coffee. BASF Corporation,
Agricultural Products requested these tolerances under the Federal
Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality
Protection Act of 1996 (FQPA).
DATES: This regulation is effective September 13, 2006. Objections and
requests for hearings must be received on or before November 13, 2006.
ADDRESSES: EPA has established a docket for this action under docket
Identification (ID) number EPA-HQ-2005-0071. All documents in the
docket are listed in the index for the docket. Although listed in the
index, some information is not publicly available, e.g., 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 in the electronic docket at http://www.regulations.gov, or,
if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S–4400, One Potomac Yard (South Building), 2777 S. Crystal
Drive, Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Docket Facility is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Mary L. Waller, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-9354; e-mail address:waller.mary@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 affectedP entities may include, but are not limited to:
Crop production (NAICS 111), e.g., agricultural workers;
greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS 112), e.g., cattle ranchers and
farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
Pesticide manufacturing (NAICS 32532), e.g., agricultural
workers; commercial applicators; farmers; greenhouse, nursery, and
floriculture workers; residential users.
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 Access Electronic Copies of this Document?
In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr
.
C. Can I File an Objection or Hearing Request?
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. You must file your objection or
request a hearing on this regulation in accordance with the
instructions provided in 40 CFR part 178. To ensure proper receipt by
EPA, you must identify docket ID number EPA-HQ-OPP-2005-0071 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 November 13, 2006.
[[Page 53985]]
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2005-0071, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
telephone number for the Docket Facility is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of September 22, 2000, (65 FR 57338) (FRL-
6737-8), and February 15, 2006, (71 FR 7952) (FRL-7759-5), EPA issued
notices pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3),
announcing the filing of pesticide petitions (PP 7E4885 and 0E6128) by
BASF Corporation, Agricultural Products, P.O. Box 13528; Research
Triangle Park, NC 27709-3528. These petitions requested that 40 CFR 180
be amended by establishing tolerances for residues of the fungicide
epoxiconazole, (2RS, 3SR)-3-(2-chlorophenyl)-2-(4-fluorophenyl)-2(1H-
1,2,4-triazol-1-yl)methyl oxirane, in or on bananas at 0.5 parts per
million (ppm) (PP 7E4885) and coffee, bean at 0.05 ppm (PP 0E6128).
These notices included a summary of the petition prepared by BASF, the
registrant. Comments were received on the notices of filing. EPA's
response to these comments is discussed in Unit IV., C below.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of 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.
Section 408(b)(2)(C) of FFDCA requires 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. . .
.''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of FFDCA, for tolerances for residues of epoxiconazole in or
on bananas at 0.5 parts per million (ppm) and coffee, bean at 0.05 ppm.
EPA's assessment of exposures and risks associated with establishing
the tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies 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. Specific information on the studies received and the nature
of the toxic effects caused by epoxiconazole as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov
under the docket ID number EPA-HQ-OPP-2005-0071-
0005.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, the dose at which the NOAEL from the toxicology study
identified as appropriate for use in risk assessment is used to
estimate the toxicological level of concern (LOC). However, the LOAEL
identified is sometimes used for risk assessment if no NOAEL was
achieved in the toxicology study selected. An uncertainty factor (UF)
is applied to reflect uncertainties inherent in the extrapolation from
laboratory animal data to humans and in the variations in sensitivity
among members of the human population as well as other unknowns.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify non-threshold hazards such as
cancer. The Q* approach assumes that any amount of exposure will lead
to some degree of cancer risk and estimates risk in terms of the
probability of occurrence of additional cancer cases. More information
can be found on the general principles EPA uses in risk
characterization at http://www.epa.gov/oppfead1/trac/science/, and
http://www.epa.gov/pesticides/factsheets/riskassess.htm.
Summaries of the toxicological endpoints for epoxiconazole used for
the human risk assessment are shown in the following Table 1.
[[Page 53986]]
Table 1.--Summary of Toxicological Dose and Endpoints for Epoxiconazole for Use in Human Risk Assessment.
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Dose used in risk
assessment, Special FQPA SF and
Exposure/Scenario interspecies and level of concern for Study and toxicological
intraspecies and any risk assessment effects
traditional UF
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Acute dietary (females 13-49 years of NOAEL = 5 mg/kg/day Special FQPA SF = 1X Developmental toxicity
age). UF = 100............... aPAD = acute RfD/...... rat
Acute RfD = 0.05 mg/kg/ Special FQPA SF = 0.05 LOAEL = 15 mg/kg/day
day. mg/kg/day. based on increased
incidence of skeletal
variations
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Chronic dietary (all populations) NOAEL = 2 mg/kg/day Special FQPA SF = 1X 2-Year rat
UF = 100............... cPAD = chronic RfD/.... carcinogenicity
Chronic RfD = 0.02 mg/ Special FQPA SF = 0.02 LOAEL = 7 mg/kg/day
kg/day. mg/kg/day. based on increased
incidences of ovarian
cysts and adrenal
histopathological
findings in females
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) Classification: Likely human carcinogen with a Q1*(mg/kg/day)-1 of 3.04 x
10-2 by oral route based on the occurrence of liver tumors in male and
female mice
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C. Exposure Assessment
1. Dietary exposure from food and feed uses. This final rule
establishes the first tolerances for residues of epoxiconazole in or on
imported bananas and coffee. There are no registered uses in the United
States, therefore the only expected exposure to epoxiconazole is from
imported bananas and coffee. Risk assessments were conducted by EPA to
assess dietary exposures from epoxiconazole in food as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a one-day or single exposure.
In conducting the acute dietary exposure assessment EPA used the
Dietary Exposure Evaluation Model software with the Food Commodity
Intake Database (DEEM-FCIDTM), which incorporates food
consumption data as reported by respondents in the United States
Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide
Continuing Surveys of Food Intake by Individuals (CSFII), and
accumulated exposure to the chemical for each commodity. The following
assumptions were made for the acute exposure assessments: The acute
analysis was based on the highly conservative assumption of tolerance-
level residues and 100% crop treated (CT).
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the DEEM-FCIDTM, which incorporates food
consumption data as reported by respondents in the USDA 1994-1996 and
1998 Nationwide CSFII, and accumulated exposure to the chemical for
each commodity. The following assumptions were made for the chronic
exposure assessments: The chronic analysis was based on the highly
conservative assumption of tolerance-level residues and 100% CT.
iii. Cancer. The Agency classified epoxiconazole as ``likely to be
carcinogenic to humans'' by the oral route based on the occurrence of
liver tumors in male and female mice. The cancer dietary exposure
estimate for the general U.S. population is 3 x10-5 mg/kg/
day. The cancer dietary exposure assessment was performed for the
general U.S. population using anticipated residues, and 100% CT.
Anticipated residues were calculated for coffee and banana using the
average field trial values from the crop field trial data.
iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide chemicals that have been
measured in food. If EPA relies on such information, EPA must require
that data be provided 5 years after the tolerance is established,
modified, or left in effect, demonstrating that the levels in food are
not above the levels anticipated. Following the initial data
submission, EPA is authorized to require similar data on a time frame
it deems appropriate. As required by section 408(b)(2)(E) of FFDCA, EPA
will issue a Data Call-In for information relating to anticipated
residues to be submitted no later than 5 years from the date of
issuance of this tolerance.
2. Dietary exposure from drinking water. There is no expectation
that epoxiconazole residues would occur in surface water or ground
water sources of drinking water. Epoxiconazole is proposed for use only
on imported coffee and banana commodities, the sole anticipated
exposure route for the U.S. population is via dietary (food) exposure.
There are no registered uses of epoxiconazole in the United States.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Epoxiconazole is not registered for use on any sites that would
result in residential exposure and a non-dietary risk assessment is not
required.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the mulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
Epoxiconazole is a member of the triazole-containing class of
pesticides. Although conazoles act similarly in plants (fungi) by
inhibiting ergosterol biosynthesis, there is not necessarily a
relationship between this pesticidal activity and their mechanism of
toxicity in mammals. Structural similarities do not constitute a common
mechanism of toxicity. Evidence is needed to establish that the
chemicals operate by the same, or essentially the same sequence of
major biochemical events (EPA, 2002). A variable pattern of
toxicological responses are found for conazoles. Some are hepatotoxic
and hepatocarcinogenic in mice. Some induce thyroid tumors in rats.
Some induce developmental, reproductive, and neurological effects in
[[Page 53987]]
rodents. Furthermore, the conazoles have a diverse range of biochemical
events including altered cholesterol levels, stress responses, and
altered DNA methylation. It is not clearly understood whether these
biochemical events are directly connected to the toxicological
outcomes. Thus, there is currently no evidence to indicate that
conazoles share common mechanisms of toxicity and EPA is not following
a cumulative risk approach based on a common mechanism of toxicity for
the conazoles. For information regarding EPA's procedures for
cumulating effects from substances found to have a common mechanism of
toxicity, see EPA's website at http://www.epa.gov/pesticides/cumulative.
The Agency's risk assessment for the common metabolites is
available in the prothioconazole reregistration docket at http://www.regulations.gov
, docket ID number EPA-HQ-OPP-2005-0497.
D. Safety Factor for Infants and Children
1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. Margins of safety are
incorporated into EPA risk assessments either directly through use of a
MOE analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans. In
applying this provision, EPA either retains the default value of 10X
when reliable data do not support the choice of a different factor, or,
if reliable data are available, EPA uses a different additional safety
factor value based on the use of traditional uncertainty factors and/or
special FQPA safety factors, as appropriate.
2. Prenatal and postnatal sensitivity.-a. There is no evidence of
susceptibility following in utero exposure in the rabbit developmental
toxicity and both in utero and postnatal exposure in the 2-generation
rat reproduction study.
b. There is low concern for the susceptibility seen in the rat
developmental toxicity study because the effects observed were
relatively mild for both the pregnant dams (decrease in body weight
gain/food consumption) and the rat pups (increased incidence of minor
skeletal variations - rudimentary cervical ribs and accessory
14th rib).
c. There does not appear to be any enhanced susceptibility in the
young to endocrine effects based on the results of the two-generation
study (parental male reduced adrenal weights were not observed in
offspring).
d. Although there is some uncertainty associated with the acute and
subchronic neurotoxicity data, it is unlikely that the information
requested to upgrade these studies will alter the NOAELs used for the
dietary endpoints. This is because the positive findings in the acute
neurotoxicity study were mild and at high doses (1,000 mg/kg in males
and 2,000 mg/kg in females). Also, the piloerection observed in the
females in the acute neurotoxicity study would likely have been noted
or recorded during the subchronic and chronic rodent studies as part of
the daily cageside observations for clinical signs. Clinical
observations were made, but no signs were noted in any of the studies.
This suggests that chronic exposure up to 80 mg/kg/day in rats (rat
carcinogenicity study) does not lead to readily observable clinical
signs such as piloerection.
e. The non-cancer dietary food exposure assessment utilizes
proposed tolerance level residues and 100% CT information for all
commodities. By using these screening-level assessments, acute and
chronic exposures/risks will not be underestimated.
f. Drinking water and residential exposure are not expected.
3. Conclusion. There is a complete toxicity data base for
epoxiconazole and exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures. There is no
evidence of susceptibility following in utero and/or postnatal exposure
in the rabbit developmental toxicity and in the 2-generation rat
reproduction study. There is low concern for the susceptibility seen in
the rat developmental toxicity study and no residual uncertainty for
prenatal and/or postnatal toxicity. There is no evidence of significant
neurotoxicity, as indicated by both the acute and subchronic
neurotoxicity studies. Acute and chronic dietary food exposure
estimates are based on conservative (Tier 1) assumptions, and will not
underestimate exposure/risk. There is no potential for drinking water
or residential exposure. Based on these data and conclusions, there are
no FQPA UFs and the FQPA Safety Factor can be reduced to 1x.
E. Aggregate Risks and Determination of Safety
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food to
epoxiconazole will occupy 2% of the aPAD for females 13-49 years, the
only population subgroup of concern. There are no proposed or existing
residential uses for epoxiconazole. The proposed uses are limited to
imported bananas and coffee. Since there are no registered uses
associated with epoxiconazole in the U.S., the only route of exposure
is dietary (food only). Aggregate risk is limited to dietary exposure
(food only) and does not exceed the Agency's level of concern.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
epoxiconazole from food will utilize 1.0% of the cPAD for the U.S.
population, 3.7% of the cPAD for all infants < 1 year, and 4.6% of the
cPAD for children 1-2 years, the most highly exposed population
subgroup. There are no residential uses for epoxiconazole that result
in chronic residential exposure to epoxiconazole, and no exposure is
expected from drinking water. Therefore, aggregate risk does not exceed
the Agency's level of concern.
3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
Epoxiconazole is not registered for use on any sites that would
result in residential exposure and there is no expectation that
epoxiconazole residues would occur via drinking water consumption.
Therefore, the aggregate risk is the sum of the risk from food, which
does not exceed the Agency's level of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Epoxiconazole is not registered for use on any sites that would
result in residential exposure and there is no expectation that
epoxiconazole residues would occur via drinking water consumption.
Therefore, the aggregate risk is the sum of the risk from food, which
does not exceed the Agency's level of concern.
5. Aggregate cancer risk for U.S. population. The Agency classified
epoxiconazole as ``likely to be carcinogenic to humans''by the oral
route based on the occurrence of liver tumors in male and female mice.
The estimated unit risk, Q1* is 3.04 x 10-2. The
cancer dietary exposure estimate for the general U.S. population is
9.03 x
[[Page 53988]]
10-7 which is below the Agency's level of concern (generally
in the range of 1x 10-6).
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to epoxiconazole residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (gas chromatography/electron
capture detector (GC/ECD) method - BASF method 309/1) is available to
enforce the tolerance expression. The method may be requested from:
Chief, Analytical Chemistry Branch, Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 0755-5350; telephone number: (410) 305-2905;
e-mail address: residuemethods@epa.gov.
B. International Residue Limits
Codex Alimentarius and Canada have not established or proposed any
MRLs for epoxiconazole. As there are no established or proposed MRLs
for either banana or coffee, harmonization with international
tolerances is not an issue for the current petitions.
C. Response to Comments
A private citizen responded to PP 0E6128. Comments were received on
February 15, 2006 objecting to the use, manufacturing and sale of this
product. The comments further stated that not enough tests have been
completed (long term or combined tests), that there is little
indication of safety and questioned the validity of animal testing.
The Agency response is as follows: The Agency has a complete
toxicity database on epoxiconazole, including several long-term or
chronic studies. The commenter submitted no scientific information or
data to support their claims. For additional in-depth response, refer
to docket EPA-HQ-OPP-2004-0325, 69 FR 63083 at http://www.regulations.gov
.
V. Conclusion
Therefore, tolerances are established for residues of
epoxiconazole, [rel-1-[[(2R,3S)-3-(2-chlorophenyl)-2-(4-
fluorophenyl)oxiranyl]methyl]-1H-1,2,4-triazole], in or on bananas at
0.5 ppm and coffee at 0.05 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
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 FFDCA, such as the tolerance 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 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.
VII. 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
[[Page 53989]]
and pests, Reporting and recordkeeping requirements.
Dated: August 28, 2006.
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 180.619 is added to read as follows:
Sec. 180.619 Epoxiconazole; tolerances for residues.
(a) General. Tolerances are established for the residues of the
fungicide epoxiconazole [(rel-1-[[(2R,3S)-3-(2-chlorophenyl)-2-(4-
fluorophenyl)oxiranyl]methyl]-1H-1,2,4-triazole]) in or on the
following commodities:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Banana*.................................................... 0.5
Coffee* 0.05
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*No U.S. Registration as of August 4, 2006
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional Registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. E6-14994 Filed 9-12-06; 8:45 am]
BILLING CODE 6560-50-S