Metconazole; Pesticide Tolerance

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

[Federal Register: September 27, 2006 (Volume 71, Number 187)]
[Rules and Regulations]
[Page 56383-56388]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27se06-15]

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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2005-0016; FRL-8085-2]

AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of
metconazole in or on bananas. BASF Agricultural Products requested this
tolerance 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 27, 2006. Objections and
requests for hearings must be received on or before November 27, 2006,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2005-0016. 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.

[[Page 56384]]

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 Docket telephone number 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 affected 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.
To access the OPPTS Harmonized Guidelines referenced in this document,
go directly to the guidelines at
http://www.epa.gov/opptsfrs/home/guidelin.htm

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-2005-0016 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 27, 2006.
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-2005-0016, 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
Docket telephone number is (703) 305-5805.

II. Background and Statutory Findings

In the Federal Register of April 8, 2005, (67 FR 18008) (FRL-7703-
7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
9E5052) by BASF Agricultural Products, 26 Davis Drive, P.O. Box 13528,
Research Triangle Park, NC 27709-3528 agent for Kureha Corporation, 3-
3-2 Nihonbashi-Hamacho, Chuo-ku, Tokyo 103-8552, Japan. The petition
requested that 40 CFR be amended by establishing a tolerance for
residues of the fungicide metconazole, 5-[(4-chlorophenyl)methyl]-2,2-
dimethyl-1-(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol, in or on bananas
at 0.05 parts per million (ppm). That notice included a summary of the
petition prepared by BASF Agricultural Products, the agent for the
petitioner. Comments were received on the notice 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.

[[Page 56385]]

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 a tolerance for residues of metconazole on
banana at 0.1 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 metconazole 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-2005-0016.

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
of concern are 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, 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.
A summary of the toxicological endpoints for metconazole used for
human risk assessment is shown in Table 1 of this unit:

Table 1.--Summary of Toxicological Dose and Endpoints for metconazole for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Acute Dietary (Females 13-49 years of NOAEL = 12 mg/kg/day Special FQPA SF = 1X Developmental toxicity
age) UF = 100............... aPAD = acute RfD/FQPA.. rats
Acute RfD = 0.12 mg/kg/ SF = 0.12 mg/kg/day.... LOAEL = 30 mg/kg/day
day. based on increases in
skeletal variations
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Chronic Dietary (All populations) NOAEL = 4.3 mg/kg/day Special FQPA SF = 1X Chronic oral toxicity -
UF = 100............... cPAD = chronic RfD/ rats
Chronic RfD = 0.04 mg/ Special FQPA. LOAEL = 13.1 mg/kg/day
kg/day. SF = 0.04 mg/kg/day.... based on increased
liver (M) weights and
associated
hepatocellular lipid
vacuolation (M) and
centrilobular
hypertrophy (M). Same
effects seen (F) at 54
mg/kg/day, plus
increased speen weight
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) Classification: ``Not Likely to be Carcinogenic to Humans''
----------------------------------------------------------------------------------------------------------------

C. Exposure Assessment

1. Dietary exposure from food and feed uses. There are currently no
tolerances established (40 CFR 180) for the residues of metconazole.
Use of metconazole on soybeans has been authorized under Section 18 of
FIFRA. Risk assessments were conducted by EPA to assess dietary
exposures from metconazole in/on imported bananas and soybeans 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 1-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, version 2.03), 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 assessment:
Tolerance level residues and 100% crop treated were assumed for bananas
and soybeans.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the software with the (DEEM-FCIDTM,
version 2.03), 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: Tolerance
level residues and 100% crop treated were assumed for bananas and soybeans.
iii. Cancer. Metconazole is classified as ``Not Likely to be
Carcinogenic to Humans'' based on convincing evidence that carcinogenic
effects are not likely below a defined dose range. A non-genotoxic mode
of action for mouse liver tumors was established. An exposure
assessment is not necessary.
2. Dietary exposure from drinking water. There is no expectation that

[[Page 56386]]

residues from metconazole use on imported banana would occur in surface
or ground water sources of drinking water. Because the Agency does not
have comprehensive monitoring data, drinking water concentration
estimates are made by reliance on simulation or modeling taking into
account data on the physical characteristics of metconazole. Further
information regarding EPA drinking water models used in pesticide
exposure assessment can be found at
http://www.epa.gov/oppefed1/models/water/models4.htm.
Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentration in Groundwater (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of
metconazole, resulting from use on soybeans for acute exposures are
estimated to be 1.57 parts per billion (ppb) for surface water and 0.04
ppb for ground water. The EDWCs for chronic exposures are estimated to
be 0.48 ppb for surface water and 0.04 ppb for ground water. Use on
imported bananas will not contribute to residues in water 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).
Metconazole is not registered for use on any sites that would
result in residential exposure.
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 cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
Metconazole 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. 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 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.
Metconazole is a triazole-derived pesticide. This class of
compounds can form the common metabolite 1,2,4-triazole and two
triazole conjugates (triazole alanine and triazole acetic acid). To
support existing tolerances and to establish new tolerances for
triazole-derivative pesticides, including metconazole, U.S. EPA
conducted a human health risk assessment for exposure to 1,2,4-
triazole, triazole alanine, and triazole acetic acid resulting from the
use of all current and pending uses of any triazole-derived fungicide.
The risk assessment is a highly conservative, screening-level
evaluation in terms of hazards associated with common metabolites
(e.g., use of a maximum combination of uncertainty factors) and
potential dietary and non-dietary exposures (i.e., high end estimates
of both dietary and non-dietary exposures). In addition, the Agency
retained the additional 10X FQPA safety factor for the protection of
infants and children. The assessment includes evaluations of risks for
various subgroups, including those comprised of infants and children.
The Agency's complete risk assessment is found in the propiconazole
reregistration docket at http://www.regulations.gov, Docket
Identification (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
Margin of Exposure (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 FQPA safety factors, as appropriate.
2. Prenatal and postnatal sensitivity. The database for metconazole
is adequate for FQPA consideration. The two-generation reproduction
study was performed with cis-only metconazole (not cis/trans
metconazole). However, the database contains a sufficient number of
subchronic and developmental toxicity studies with cis/trans
metconazole to adequately assess cis/trans metconazole toxicity and to
bridge the data gap. In addition, acceptable development toxicity
studies are available in both rats and rabbits. The effect seen in
these studies do not indicate that pups are more susceptible: pup
effects were only seen in the presence of maternal toxicity and, in
general, were of comparable or less severity to the effects observed in
adults. Metconazole did not exhibit neurotoxicity in any of the
submitted data.
3. Conclusion. There is a complete toxicity data base for
metconazole 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 developmental toxicity studies in rats or rabbits, and in the 2-
generation rat reproduction study. There are no residual uncertainties
concerning prenatal and postnatal toxicity and no neurotoxicity
concerns. The acute and chronic dietary (food + drinking water)
exposure assessments are conservative assessments that are based on
reliable data and will not underestimate exposure/risk. There is no
potential for drinking water exposure from the proposed use on imported
bananas. Additionally, there is no potential for residential exposure.
Based on these data and conclusions, the FQPA Safety Factor is reduced
to 1X.

E. Aggregate Risks and Determination of Safety

To assess aggregate risk, drinking water estimates were
incorporated directly into the dietary analysis, rather than using
back-calculated drinking water levels of comparison (DWLOCs).

[[Page 56387]]

To better evaluate aggregate risk associated with exposure through
food and drinking water, EPA is no longer comparing Estimated Drinking
Water Concentrations (EDWCs) generated by water quality models with
DWLOC. Instead, EPA is now directly incorporating the actual water
quality model output concentrations into the risk assessment. This
method of incorporating water concentration into our aggregate
assessments relies on actual CSFII reported drinking water consumptions
and more appropriately reflects the full distribution of drinking water
concentrations.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to metconazole will occupy < 1% of the aPAD for females 13 years and
older, the only population subgroup of concern. EPA does not expect the
aggregate exposure to exceed 100% of the aPAD, and therefore is below
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
metconazole from food and water will utilize 2% of the cPAD for the
U.S. population, 5% of the cPAD for children 1-2 years old, the most
highly exposed population subgroup. There are no residential uses for
metconazole that result in chronic residential exposure to metconazole.
EPA does not expect the aggregate exposure to exceed 100% of the cPAD,
and therefore is below 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).
Metconazole is not registered for use on any sites that would
result in residential exposure. Therefore, the aggregate risk is the
sum of the risk from food and water, which do 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).
Metconazole is not registered for use on any sites that would
result in residential exposure. Therefore, the aggregate risk is the
sum of the risk from food and water, which do not exceed the Agency's
level of concern.
5. Aggregate cancer risk for U.S. population. The Agency has
classified metconazole as ``Not Likely to be Carcinogenic to Humans''
based on convincing evidence that carcinogenic effects are not likely
below a defined dose range and that carcinogenic effects were seen in
animals only at higher doses. A non-genotoxic mode of action for mouse
liver tumors was established. Given that metconazole's cancer effects
are a threshold effect and that the threshold is well above other
chronic effects, the chronic RfD is protective against any cancer risk.
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 metconazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology (gas chromatography/nitrogen
phosphorus detection (GC/NPD) method (American Cyanamid Method M 2722))
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 20755-5350; telephone
number: (410) 305-2905; e-mail address: residuemethods@epa.gov.

B. International Residue Limits

There are currently no Canadian, Mexican or Codex MRL or tolerances
for metconazole.

C. Response to Comments

A private citizen responded to PP 9E5052. Comments were received on
April 17, 2005 objecting to the use and sale of this product, animal
testing, profiteering and lack of satisfactory combined and long-term
testing. The Agency response is as follows: The Agency has a toxicity
data base and it is considered sufficient to adequately assess
metconazole, which includes several long-term or chronic studies. The
commenter submitted no scientific information or data to support their
claims. EPA has responded to such generalized comments on numerous
previous occasions, for example, on January 7, 2005 (70 FR 1354) (FRL-
7681-9) and on October 29, 2004 (69 FR 63083) (FRL-7691-4).

V. Conclusion

Therefore, a tolerance is established for residues of metconazole,
5-[(4-chlorophenyl)methyl]-2,2-dimethyl-1-(1H-1,2,4-triazol-1-
ylmethyl)cyclopentanol, in or on banana at 0.1 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-). 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 104-13, 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

[[Page 56388]]

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 (59 FR 22951, 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 and pests, Reporting and
recordkeeping requirements.

Dated: September 18, 2006.
James Jones,
Director, Office of Pesticide Programs.

? Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

? 1. The authority citation for part 180 continues to read as follows:

Authority: 21 U.S.C. 321(q), 346a and 371.

? 2. Section 180.617 is added to read as follows:

Sec. 180.617 Metconazole; tolerances for residues.

(a) General. Tolerances are established for the residue of the
fungicide metconazole (5-[(4-chlorophenyl)methyl]-2,2-dimethyl-1-(1H-
1,2,4-triazol-1-ylmethyl)cyclopentanol) in or on the following commodity:

------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Banana1........................................ 0.1
------------------------------------------------------------------------
\1\ No U.S. registration as of August 30, 2006.

(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 06-8256 Filed 9-26-06; 8:45 am]
BILLING CODE 6560-50-S

Notices For
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Metconazole; Pesticide Tolerance

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