Document ID: EPA-HQ-OPP-2005-0071-0005
Agency: epa
Document Type: Rule
Title: Epoxiconazole; Pesticide Tolerance
Posted Date: 2006-09-13T13:12:59Z

[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.
----------------------------------------------------------------------------------------------------------------
                                          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 = 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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------

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]

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

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

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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
------------------------------------------------------------------------
*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]

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