Document ID: EPA-HQ-OPP-2005-0016-0003
Agency: epa
Document Type: Rule
Title: Metconazole; Pesticide Tolerance
Posted Date: 2006-09-27T13:18:37Z

[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]

 
Metconazole; Pesticide Tolerance

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 athttp://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.gpo/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
----------------------------------------------------------------------------------------------------------------
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/[fxsp0]oppefed1/

models/water/[fxsp0]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 (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 and pests, Reporting and 
recordkeeping requirements.

    Dated: September 18, 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 180.617 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]

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