[Federal Register Volume 70, Number 45 (Wednesday, March 9, 2005)]
[Rules and Regulations]
[Pages 11572-11583]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-4474]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0410; FRL-7699-2]


Fenbuconazole; Time-Limited Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance for the 
combined residues of fenbuconazole [alpha-[2-(4-chlorophenyl)-ethyl]-
alpha-phenyl-3-(1H-1,2,4-triazole)-1-propanenitrile] and its 
metabolites cis- andtrans-5-(4-chlorophenyl)-dihydro-3-phenyl-3-(1H-
1,2,4-triazole-1-ylmethyl)-2-3H-furanone, expressed as fenbuconazole in 
or on bananas (whole fruit); pecans; and stone fruit crop group (except 
plums and prunes). Dow AgroSciences, LLC requested this tolerance under 
the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the 
Food Quality Protection Act of 1996 (FQPA). The tolerance will expire 
on December 31, 2008.

DATES: This regulation is effective March 9, 2005. Objections and 
requests for hearings must be received on or before May 9, 2005.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VI. of theSUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under docket 
identification (ID) number OPP-2004-0410. All documents in the docket 
are listed in the EDOCKET index athttp://www.epa.gov/edocket. Although 
listed in the index, some information is not publicly available, i.e., 
CBI or other information whose disclosure is restricted by statute. 
Certain other material, such as copyrighted material, is not placed on 
the Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available either electronically 
in EDOCKET or in hard copy at the Public Information and Records 
Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1801 S. 
Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to 
4 p.m., Monday through Friday, excluding legal holidays. The docket 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: J. R. Tomerlin, Registration Division 
(0705C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-0598; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111)
     Animal production (NAICS code 112)
     Food manufacturing (NAICS code 311)
     Pesticide manufacturing (NAICS code 32532)
    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 underFOR FURTHER INFORMATION CONTACT.

 B. How Can I Access Electronic Copies of this Document and Other 
Related Information?

    In addition to using EDOCKET (http://www.epa.gov/edocket/), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at http://www.epa.gov/
fedrgstr/. A frequently updated electronic version of 40 CFR part 180 
is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/. 
To access the OPPTS Harmonized Guidelines referenced in this document, 
go directly to the guidelines athttp://www.epa.gpo/opptsfrs/home/
guidelin.htm/.

II. Background and Statutory Findings

    In the Federal Register of November 17, 2004 (69 FR 67351) (FRL-
7686-6), EPA issued a notice pursuant to section 408(d)(3) of the 
FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of pesticide 
petitions (PP 1F3989, 1F3995, and 2F4154) by Dow AgroSciences, LLC, 
9330 Zionsville Road, Indianapolis, IN 46268. The petitions requested 
that 40 CFR 180.480 be amended by establishing a tolerance for combined 
residues of the fungicide fenbuconazole [alpha-[2-(4-chlorophenyl)-
ethyl]-alpha-phenyl-3-(1H-1,2,4-triazole)-1-propanenitrile] and its 
metabolites cis- andtrans-5-(4-chlorophenyl)-dihydro-3-phenyl-3-(1H-
1,2,4-triazole-1-ylmethyl)-2-3H-furanone, in or on banana (whole fruit) 
at 0.3 parts per million (ppm) (2F4154); fruit, stone, group 12 (except 
plum, prune) at 2.0 ppm (1F3989); pecan at 0.1 ppm (1F3995). This 
notice included a summary of the petition prepared by Dow AgroSciences, 
LLC, the registrant.
    The tolerances will expire on December 31, 2008.
    Comments were received in response to the notice of filing from one 
individual. These comments are addressed in Unit IV.C.
    Section 408(b)(2)(A)(i) of the 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 the FFDCA defines ``safe'' to mean that ``there is 
a reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of the FFDCA requires EPA to give special 
consideration to

[[Page 11573]]

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 the final rule on 
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed 
the available scientific data and other relevant information in support 
of this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2) of the FFDCA, for a tolerance for combined residues of banana 
(whole fruit) at 0.3 parts per million (ppm); fruit, stone, group 12 
(except plum, prune) at 2.0 ppm; pecan 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. The nature of the toxic effects caused by fenbuconazole are 
discussed in Table 1 of this unit as well as the no observed adverse 
effect level (NOAEL) and the lowest observed adverse effect level 
(LOAEL) from the toxicity studies reviewed.

                               Table 1.-- Subchronic, Chronic, and Other Toxicity
----------------------------------------------------------------------------------------------------------------
             Guideline No.                       Study Type                            Results
----------------------------------------------------------------------------------------------------------------
870.3100                                 90-Day oral toxicity        NOAEL = 1.3/1.5 mg/kg/day (M/F)
                                          rodents - rats             LOAEL = 5.1/6.3 mg/kg/day (M/F) based on
                                                                      liver histopathology
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870.3100                                 90-Day oral toxicity        NOAEL = 3.8/5.7 mg/kg/day (M/F)
                                          rodents - mice             LOAEL = 11.1/17.6 mg/kg/day (M/F) based on
                                                                      liver histopathology
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870.3150                                 90-Day oral toxicity in     NOAEL = 3.3/3.5 mg/kg/day (M/F)
                                          nonrodents - dogs          LOAEL = 13.3/14.0 mg/kg/day (M/F) based on
                                                                      liver histopathology
----------------------------------------------------------------------------------------------------------------
870.3200                                 21/28-Day dermal toxicity - NOAEL = 1,000 mg/kg/day (HDT)
                                           rats                      LOAEL = > 1,000 mg/kg/day
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870.3250                                 90-Day dermal toxicity      Not performed
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870.3465                                 90-Day inhalation toxicity  Not performed
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870.3700                                 Prenatal developmental in   Maternal NOAEL = 30 mg/kg/day
                                          rodents - rats             Maternal LOAEL = 75 mg/kg/day based on
                                                                      decreased body weight and body weight gain
                                                                     Developmental NOAEL = 30 mg/kg/day
                                                                     Developmental LOAEL = 75 mg/kg/day based on
                                                                      increased post-implantation loss and a
                                                                      decrease in the number of live fetuses/dam
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870.3700                                 Prenatal developmental in   Maternal NOAEL = 10 mg/kg/day
                                          nonrodents - rabbits       Maternal LOAEL = 30 mg/kg/day based on
                                                                      decreased food consumption and increased
                                                                      incidence of clinical signs (soft/scant/no
                                                                      feces and red discharge)
                                                                     Developmental NOAEL = 30 mg/kg/day
                                                                     Developmental LOAEL = 60 mg/kg/day based on
                                                                      increased early resorptions
----------------------------------------------------------------------------------------------------------------
870.3800                                 Reproduction and fertility  Parental systemic NOAEL = 4 mg/kg/day
                                          effects - rats             Parental systemic LOAEL = 40 mg/kg/day
                                                                      based on maternal death during delivery,
                                                                      decreased body weight and food
                                                                      consumption, increased number of dams not
                                                                      delivering viable or delivering nonviable
                                                                      offspring, and increased adrenal and
                                                                      thyroid/parathyroid weights
                                                                     Reproductive NOAEL = 40 mg/kg/day (HDT)
                                                                     Reproductive LOAEL = greater than 40 mg/kg/
                                                                      day
                                                                     Offspring systemic NOAEL: 4 mg/kg/day
                                                                     Offspring systemic LOAEL: 40 mg/kg/day
                                                                      based on decreased pup body weight,
                                                                      increased number of stillborn pups,
                                                                      decreased number of total offspring
                                                                      delivered and decreased viability indes
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870.4100                                 Chronic toxicity - rodents  Requirements met by submission of studies
                                                                      according to OPPTS Harmonized Guideline
                                                                      870.4300
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[[Page 11574]]

 
870.4100                                 Chronic toxicity - dogs     NOAEL = 3.75/0.38 mg/kg/day (M/F)
                                                                     LOAEL = 30/3.75 mg/kg/day (M/F) based on
                                                                      decreased body weight gain
                                                                     Note: Dose-related adaptive liver changes
                                                                      were observed in high-dose males and
                                                                      females
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870.4200                                 Carcinogenicity - rats      Requirements met by submission of studies
                                                                      according to OPPTS Harmonized Guideline
                                                                      870.4300
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870.4200                                 Carcinogenicity - mice      NOAEL = 1.43 mg/kg/day (both M and F)
                                                                     LOAEL = 28.6/92.9 mg/kg/day (M/F) based on
                                                                      decreased body weight, increased relative
                                                                      and absolute liver weight, and
                                                                      hepatocellular hypertrophy and
                                                                      vacuolization
                                                                     Evidence of carcinogenicity
----------------------------------------------------------------------------------------------------------------
870.4300                                 Combined chronic toxicity/  NOAEL = 3.0/4.0 mg/kg/day (M/F)
                                          carcinogenicity - rat      LOAEL = 30.6/43.1 mg/kg/day (M/F) based on
                                                                      decreased body weight gain (F),
                                                                      hepatocellular enlargement and
                                                                      vacuolization (F), increased thyroid
                                                                      weight (M and F), and histopathological
                                                                      lesions in the thyroid gland (M)
                                                                     Evidence of carcinogenicity
----------------------------------------------------------------------------------------------------------------
870.4300                                 Combined chronic toxicity/  NOAEL = Not established
                                          carcinogenicity - rat      LOAEL = 30.4 mg/kg/day (M) based on
                                                                      decreased body weight gain, increased
                                                                      liver weight, and increased thyroid and
                                                                      parathyroid weights
                                                                     Note: Only males were used in this study.
                                                                      Insufficient evidence of carcinogenicity
----------------------------------------------------------------------------------------------------------------
870.5100                                 Gene mutation - bacterial   No mutagenic activity in bacteria
                                          reverse mutation assay      (Salmonella typhimurium) under conditions
                                                                      of this assay.
                                                                     Note: Only TA1535, TA1537, TA98, and TA100
                                                                      were tested. This study is classified
                                                                      unacceptable.
----------------------------------------------------------------------------------------------------------------
870.5100                                 Gene mutation - bacterial   No mutagenic activity in bacteria
                                          reverse mutation assay      (Salmonella typhimurium) under conditions
                                                                      of this assay.
                                                                     Note: Only TA1535, TA1537, TA98, and TA100
                                                                      were tested. This study is classified
                                                                      unacceptable.
----------------------------------------------------------------------------------------------------------------
870.5300                                 Cytogenetics -  in vitro    No increase in mutant frequency at the
                                          mammalian cell gene         HGPRT locus, in the presence or absence of
                                          mutation test (CHO Cells)   S9 activation.
----------------------------------------------------------------------------------------------------------------
870.5385                                 Cytogenetics - mammalian    No increase in number of cells with
                                          bone marrow chromosomal     aberrations or in aberrations per cell.
                                          aberration test (rats)
----------------------------------------------------------------------------------------------------------------
870.5550                                 Other effects -             No evidence (or a dose related positive
                                          unscheduled DNA synthesis   response) that unscheduled DNA synthesis
                                          in mammalian cells in       was induced.
                                          culture (rats)
----------------------------------------------------------------------------------------------------------------
870.7485                                 Metabolism and              The mean recovery of radioactivity 4 days
                                          pharmacokinetics - rat      after exposure was 82.6-93.0% following
                                                                      single or repeated oral doses and 88.2-
                                                                      99.2% following single i.v. doses,
                                                                      indicating rapid absorption, distribution,
                                                                      and elimination. Rapid elimination and low
                                                                      tissue levels indicate low bioaccumulation
                                                                      of the parent and metabolites.
                                                                     Elimination occurred primarily by biliary
                                                                      excretion because recovery of
                                                                      radioactivity was mostly in the feces:
                                                                      75.6-83.7% following oral exposure and
                                                                      77.2-91.4% following i.v. exposure. In
                                                                      urine, radioactivity recovery was 5.5-
                                                                      12.6% for all dose scenarios. Peak
                                                                      radioactivity in the blood occurred 3
                                                                      hours following a single low dose and 3-6
                                                                      hours after a single high dose, indicating
                                                                      biphasic elimination.
                                                                     Only 8.5-14.8% and 0.0-2.7% of the parent
                                                                      compound was recovered in the feces and
                                                                      urine, respectively, indicating extensive
                                                                      metabolism. A number of major metabolites
                                                                      were identified; however, 50% and 20% of
                                                                      metabolites in the feces and urine,
                                                                      respectively, were not identified. Sex-
                                                                      related differences include a greater
                                                                      number of sulfate metabolites in female
                                                                      excreta compared to males, and a greater
                                                                      number of ketoacid metabolites in male
                                                                      urine compared to females.
----------------------------------------------------------------------------------------------------------------

[[Page 11575]]

 
870.7485                                 Metabolism and              The mean recovery of radioactivity 3-4 days
                                          pharmacokinetics - rat      after exposure was 90.4-104.5% following
                                                                      single or repeated oral doses, indicating
                                                                      rapid absorption, distribution, and
                                                                      elimination. Bioaccumulation of the parent
                                                                      compound and metabolites is low. There
                                                                      were no major sex- or dose-related
                                                                      differences in absorption, distribution,
                                                                      or elimination.
                                                                     Elimination occurred primarily by biliary
                                                                      excretion: Recovery of the administered
                                                                      dose occurred mainly in the bile (79.1-
                                                                      87.1%) 3 days after exposure and mostly in
                                                                      the feces (78.7-94.4%) 4 days after
                                                                      exposure. In contrast, radioactivity
                                                                      recovery in the urine was 3.2-11.5% at 3
                                                                      and 4 days after exposure.
                                                                     Extensive metabolism occurred; numerous
                                                                      metabolites were found in the feces and
                                                                      urine. There is a dose-related difference
                                                                      in metabolism. A higher amount of parent
                                                                      compound was found in the feces following
                                                                      the single high dose compared to the
                                                                      single or repeated low dose(s), which
                                                                      suggests that saturation may be occurring
                                                                      at the high dose.
----------------------------------------------------------------------------------------------------------------
870.7600                                 Dermal penetration - rat    The highest dermal absorption was found in
                                                                      animals having the longest exposure dose.
                                                                     Mean % of the dose absorbed (sum of urine,
                                                                      feces, carcass, and skin) after 10 hours
                                                                      of exposure:
                                                                     Dose (mg/kg) Percent Dermal Absorption
                                                                     0.125 4.25
                                                                     1.25 2.08
                                                                     125 0.45
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B. Toxicological Endpoints

    The dose at which no adverse effects are observed (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 lowest dose at which adverse effects of concern are 
identified (the LOAEL) 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. An UF of 100 is routinely used, 10X to account for 
interspecies differences and 10X for intraspecies differences.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by the 
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is 
retained due to concerns unique to the FQPA, this additional factor is 
applied to the RfD by dividing the RfD by such additional factor. The 
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a 
modification of the RfD to accommodate this type of FQPA Safety Factor 
(SF).
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the LOC. For example, when 100 is the appropriate UF (10X 
to account for interspecies differences and 10X for intraspecies 
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to 
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and 
compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk is expressed as1 x 10-\6\ or one in a million). 
Under certain specific circumstances, MOE calculations will be used for 
the carcinogenic risk assessment. In this non-linear approach, a 
``point of departure'' is identified below which carcinogenic effects 
are not expected. The point of departure is typically a NOAEL based on 
an endpoint related to cancer effects though it may be a different 
value derived from the dose response curve. To estimate risk, a ratio 
of the point of departure to exposure(MOEcancer = point of 
departure/exposures) is calculated. A summary of the toxicological 
endpoints for fenbuconazole used for human risk assessment is shown in 
Table 2 of this unit:

    Table 2.--Summary of Toxicological Dose and Endpoints for Fenbuconaozle for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                  Special FQPA SF* and
          Exposure Scenario               Dose Used in Risk       Level of Concern for   Study and Toxicological
                                            Assessment, UF          Risk Assessment              Effects
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Acute dietary (females 13-49 years of  NOAEL = 30 mg/kg/day     Special FQPA SF = 1      Developmental rat study
 age)                                  UF = 100a..............   aPAD = acute RfD /      Developmental LOAEL =
                                       Acute RfD = 0.3 mg/kg..   FQPA SF = 0.3 mg/kg      75 mg/kg/day based on
                                                                                          increased resorptions
                                                                                          and decreased live
                                                                                          fetuses per dam
----------------------------------------------------------------------------------------------------------------

[[Page 11576]]

 
Acute dietary (general population      None                     None                     Not selected
 including infants and children)                                                         No appropriate dose and
                                                                                          endpoint could be
                                                                                          identified for these
                                                                                          population groups.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (all populations)      NOAEL = 3 mg/kg/day      Special FQPA SF = 1      Combined chronic
                                       UF = 100a..............  cPAD = chronic RfD /      toxicity/
                                       Chronic RfD = 0.03 mg/    FQPA SF = 0.03 mg/kg/    carcinogenicity - rat
                                        kg/day.                  day.                    LOAEL = 30.6/43.1 (M/F)
                                                                                          mg/kg/day based on
                                                                                          decreased body weight
                                                                                          gain, increased
                                                                                          thyroid weight, and
                                                                                          histopathological
                                                                                          lesions in the liver
                                                                                          and thyroid gland
----------------------------------------------------------------------------------------------------------------
Incidental oral (all durations)        None                     None                     Not selected
                                                                                         No registered uses
                                                                                          would result in
                                                                                          residential exposure
-----------------------------------------------------------------------------------------
Short-term (1 to 30 days) and          None                     None                     Not selected
 intermediate-term (1 to 6 months)                                                       No dermal or systemic
Dermal...............................                                                     toxicity was seen in a
                                                                                          21-day dermal toxicity
                                                                                          study; poor absorption
                                                                                          was seen in the dermal
                                                                                          absorption study
-----------------------------------------------------------------------------------------
Long-term dermal (several months to    Oral study NOAEL = 3 mg/ Residential LOC for MOE  Combined chronic
 lifetime)                              kg/day                   = Not applicable         toxicity/
                                       (dermal absorption rate  Occupational LOC for      carcinogenicity - rat
                                        = 4.25%).                MOE = 100\a\.           LOAEL = 30.6/43.1 (M/F)
                                                                                          mg/kg/day based on
                                                                                          decreased body weight
                                                                                          gain, increased
                                                                                          thyroid weight, and
                                                                                          histopathological
                                                                                          lesions in the liver
                                                                                          and thyroid gland
-----------------------------------------------------------------------------------------
Inhalation (all durations)             None                     None                     Not selected
                                                                                         Low toxicity and use
                                                                                          pattern does not
                                                                                          indicate a need for
                                                                                          risk assessment via
                                                                                          inhalation.
-----------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)             Classification: Under the 1986 cancer classification scheme,
                                         fenbuconazole was classified as a Group C - Possible Human Carcinogen,
                                         with a low dose extrapolation model applied to the animal data for the
                                             quantification of human risk (Q1*). This was based on increased
                                         incidence of hepatocellular adenomas and carcinomas in male and female
                                        mice and of thyroid follicular adenomas and combined adenomas/carcinomas
                                           in male rats. Based on mechanistic data, quantification of risk was
                                           derived using combined hepatocellular adenomas/carcinomas in female
                                        mice. The upper bound estimate of unit risk, Q1* (mg/kg/day)-\1\ is 3.59
                                                             x 10-\3\ in human equivalents.
----------------------------------------------------------------------------------------------------------------
*Database uncertainty factor reduced to 1X.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.480) for the combined residues of 
fenbuconazole, in or on a variety of raw agricultural commodities. Risk 
assessments were conducted by EPA to assess dietary exposures from 
fenbuconazole in food as follows:
     i. Acute exposure. Acute dietary 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. The Dietary Exposure Evaluation Model (DEEM\TM\) 
analysis evaluated the individual food consumption as reported by 
respondents in the U.S. 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: 
Tolerance level residues were used for all food commodities, 100% of 
all commodities were assumed to be treated, and default processing 
factors were used for processed commodities.
     ii. Chronic exposure. In conducting this chronic dietary risk 
assessment, the DEEM\TM\ analysis evaluated the food consumption as 
reported by respondents in the USDA 1994-1996 and 1998 CSFII and 
accumulated exposure to the chemical for each commodity. The following 
assumptions were made for the chronic exposure assessments: The chronic 
analysis is slightly refined in that it incorporates estimates of 
average percent crop treated (PCT), although it does use tolerance 
value residues for most commodities and default processing factors. 
Anticipated residues from USDA Pesticide Data Program monitoring data 
were used only for banana in the chronic dietary exposure analysis and 
risk assessment.
    iii. Cancer. Chronic cancer risk for the overall U.S. population 
was estimated by multiplying the chronic exposure

[[Page 11577]]

estimate by the carcinogenic potential (Q*) of 0.0359 (mg/kg/
day)-\1\.
    Section 408(b)(2)(E) of the 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 the 
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.
    Section 408(b)(2)(F) of the FFDCA states that the Agency may use 
data on the actual percent of food treated for assessing chronic 
dietary risk only if the Agency can make the following findings: 
Condition 1, that the data used are reliable and provide a valid basis 
to show what percentage of the food derived from such crop is likely to 
contain such pesticide residue; Condition 2, that the exposure estimate 
does not underestimate exposure for any significant subpopulation 
group; and Condition 3, if data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area. In addition, the 
Agency must provide for periodic evaluation of any estimates used. To 
provide for the periodic evaluation of the estimate of percent crop 
treated (PCT) as required by section 408(b)(2)(F) of the FFDCA, EPA may 
require registrants to submit data on PCT.
    The Agency used PCT information as follows:
    A routine chronic dietary exposure analysis for the fungicide 
fenbuconazole and itscis and trans metabolites was based on 10% of 
apricot crop treated, 25% of blueberry crop treated, 25% of cherry crop 
treated, 30% of grapefruit crop treated, 15% of nectarine crop treated, 
15% of peach crop treated, and 10% of pecan crop treated.
    The Agency believes that the three conditions previously discussed 
have been met. With respect to Condition 1, EPA finds that the PCT 
information for fenbuconazole is reliable and has a valid basis. Time-
limited tolerances have existed for all crop commodities included in 
the risk assessment, and the Agency obtained estimates of fenbuconazole 
use from recognized pesticide use data bases. As to Conditions 2 and 3, 
regional consumption information and consumption information for 
significant subpopulations is taken into account through EPA's 
computer-based model for evaluating the exposure of significant 
subpopulations including several regional groups. Use of this 
consumption information in EPA's risk assessment process ensures that 
EPA's exposure estimate does not understate exposure for any 
significant subpopulation group and allows the Agency to be reasonably 
certain that no regional population is exposed to residue levels higher 
than those estimated by the Agency. Other than the data available 
through national food consumption surveys, EPA does not have available 
information on the regional consumption of food to which fenbuconazole 
may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for fenbuconazole in 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 fenbuconazole.
    The Agency uses the Generic Estimated Environmental Concentration 
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System 
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and 
SCI-GROW, which predicts pesticide concentrations in ground water. In 
general, EPA will use GENEEC (a Tier 1 model) before using PRZM/EXAMS 
(a Tier 2 model) for a screening-level assessment for surface water. 
The GENEEC model is a subset of the PRZM/EXAMS model that uses a 
specific high-end runoff scenario for pesticides. GENEEC incorporates a 
farm pond scenario, while PRZM/EXAMS incorporate an index reservoir 
environment in place of the previous pond scenario. The PRZM/EXAMS 
model includes a percent crop area factor as an adjustment to account 
for the maximum percent crop coverage within a watershed or drainage 
basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a coarse screen for sorting out pesticides for 
which it is highly unlikely that drinking water concentrations would 
ever exceed human health levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs) from these models to quantify 
drinking water exposure and risk as a %RfD or %PAD. Instead drinking 
water levels of comparisons (DWLOCs) are calculated and used as a point 
of comparison against the model estimates of a pesticide's 
concentration in water. DWLOCs are theoretical upper limits on a 
pesticide's concentration in drinking water in light of total aggregate 
exposure to a pesticide in food, and from residential uses. Since 
DWLOCs address total aggregate exposure to fenbuconaozle, they are 
further discussed in the aggregate risk sections in Unit III.E.
    Based on the PRZM/EXAMS and SCI-GROW models, the estimated EECs of 
fenbuconazole for acute exposures are estimated to be 14.1 parts per 
billion (ppb) for surface water and 0.005 ppb for ground water. The 
EECs for chronic exposures are estimated to be 7.3 ppb (peak annual) 
and 5.9 ppb (30-year average) for surface water and 0.005 ppb for 
ground water.
    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).
    Fenbuconazole is not registered for use on any sites that would 
result in residential exposure.
    4. Cumulative exposure to 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.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, fenbuconazole 
does not appear to produce a toxic metabolite produced by other 
substances. For the purposes of this tolerance action, therefore, EPA 
has not assumed that fenbuconazole has a common mechanism of toxicity 
with other substances. For information regarding EPA's efforts to 
determine which chemicals have a common mechanism of toxicity and to 
evaluate

[[Page 11578]]

the cumulative effects of such chemicals, see the final rule for 
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).
    However, the Agency does have concern about potential toxicity to 
1,2,4-triazole and two conjugates, triazolylalanine and triazolyl 
acetic acid, metabolites common to most of the triazole fungicides. To 
support the extension of existing parent triazole-derivative fungicide 
tolerances, EPA conducted an interim human health assessment for 
aggregate exposure to 1,2,4-triazole. The exposure and risk estimates 
presented in this assessment are overestimates of actual likely 
exposures and therefore, should be considered to be highly 
conservative. Based on this assessment, EPA concluded that for all 
exposure durations and population subgroups, aggregate exposures to 
1,2,4-triazole are not expected to exceed its level of concern. This 
assessment should be considered interim due to the ongoing series of 
studies being conducted by the U.S. Triazole Task Force (USTTF). Those 
studies are designed to provide the Agency with more complete 
toxicological and residue information for free triazole and are 
expected to be submitted to the Agency in late 2004 and early 2005. 
Upon completion of review of these data, EPA will prepare a more 
sophisticated assessment based on the revised toxicological and 
exposure data bases.
    i. Toxicology. The toxicological data base for 1,2,4-triazole is 
incomplete. Preliminary summary data presented by the USTTF to EPA 
indicate that the most conservative endpoint currently available for 
use in a risk assessment for 1,2,4-triazole is a LOAEL of 15 mg/kg/day, 
based on body weight decreases in male rats in the reproductive 
toxicity study (currently underway). This endpoint, with an uncertainty 
factor of 1,000 was used for both acute and chronic dietary risk, 
resulting in an RfD of 0.015 mg/kg/day. The uncertainty factor of 1,000 
includes an additional 10X safety factor for the protection of infants 
and children. The resulting PAD is 0.015 mg/kg/day.
    ii. Dietary exposure. The USTTF conducted an acute dietary exposure 
assessment based on the highest triazole-derivative fungicide tolerance 
level combined with worst-case molecular weight and plant/livestock 
metabolic conversion factors. This approach provides a conservative 
estimate of all sources for 1,2,4-triazole except the in vivo 
conversion of parent compounds to free-triazole following dietary 
exposure. The degree of animal in vivo conversion is dependent on the 
identity of the parent fungicide. In rats, this conversion ranges from 
0% to 77%, thein vivo conversion for fenbuconaozle is 2.5%. For 
purposes of this interim assessment, EPA used the dietary exposure 
estimates provided by the USTTF adjusted based on the highest rate of 
conversion observed for any of the parent triazole-derivative 
fungicides to account for this metabolic conversion. The assessment 
includes residue estimates for all food commodities with either 
existing or pending triazole-derivative fungicide registrations. The 
resulting acute dietary exposure estimates are extremely conservative 
and range from 0.0032 mg/kg/day for males 20+ years old to 0.014 mg/kg/
day for children 1 to 6 years old. Estimated risks range from 22% to 
93% of the PAD. In order to estimate chronic exposures via food, EPA 
used the 70th percentile of exposures from the acute assessment. The 
70th percentile is a common statistic used to estimate central tendency 
from a distribution and its use to estimate chronic exposures is 
appropriate. Estimated risks range from 10% to 47% of the PAD. It is 
emphasized that the use of both highest tolerance level residues and 
the highest in vivo conversion factor results in dietary risk estimates 
that far exceed the likely actual risk.
    iii. Non-dietary exposure. Triazole-derivative fungicides are 
registered for use on turf, resulting in the potential for residues of 
free triazole in grass and/or soil. Thus dermal and incidental oral 
exposures to children may occur. It is believed that residues of free 
triazole occur within the plant matrices and are not available as 
surface residues. Therefore, direct dermal exposure to 1,2,4-triazole 
due to contact with plants is not likely to occur. However, dermal 
exposure to parent fungicide and subsequent in vivo conversion to 
1,2,4-triazole may occur. In order to account for this indirect 
exposure to free triazole, EPA used a conversion factor of 10%, which 
is the highest rate of  in vivo conversion observed in rats for any of 
the triazole-derivative fungicides with registrations on turf. 
Incidental oral exposure may occur by direct and indirect routes. To 
assess direct exposure, EPA used a conversion factor of 17%, which is 
the highest rate of conversion to free triazole observed in any of the 
plant metabolism studies. As with indirect dermal exposure, EPA used a 
conversion factor of 10% in its assessment of indirect oral exposure. 
Based on residential exposure values estimated for propiconazole 
(0.0005 mg/kg/day via the dermal route and 0.03 mg/kg/day via the oral 
route) and the conversion factors described above, combined direct and 
indirect dermal exposures are estimated to be less than 0.0001 mg/kg/
day and combined oral exposures are estimated to be less than 0.0019 
mg/kg/day. The overall residential exposure is likely to be less than 
0.0020 mg/kg/day. Relative to the 15 mg/kg/day point of departure, this 
gives an MOE of approximately 7,500 for children. Based on the current 
set of uncertainty factors, the target MOE is 1,000, indicating that 
the risk associated with residential exposure to 1,2,4-triazole for 
children is below EPA's level of concern. The adult dermal exposure 
estimate is slightly less than that of children. Incidental oral 
exposure is not expected to occur with adults.
    iv. Drinking water. Modeled estimates of 1,2,4-triazole residues in 
surface water and ground water, as reported by the USTTF, and the DWLOC 
approach were used to address exposure to free triazole in drinking 
water. EECs of free triazole in ground water were obtained from the 
SCI-GROW model and range from 0.0 to 0.026 ppb, with the higher 
concentrations associated with uses on turf. Surface water EECs were 
obtained using the FIRST model. Acute surface water EECs ranged from 
0.29 to 4.64 ppb for agricultural uses and up to 32.1 ppb from use on 
golf course turf. EPA notes that ground water monitoring studies in New 
Jersey and California showed maximum residues of 16.7 and 0.46 ppb, 
respectively, which exceed the SCI-GROW estimates significantly. 
Contrariwise, preliminary monitoring data from USDA's Pesticide Data 
Program for 2004 show no detectable residues of 1,2,4-triazole in any 
drinking water samples, either treated or untreated (maximum LOD = 0.73 
ppb, n = 40 each).
    v. Aggregate exposure. In estimating aggregate exposure, EPA 
combined potential dietary and non-dietary sources of 1,2,4-triazole. 
To account for the drinking water component of dietary exposure, EPA 
used the DWLOC approach, as noted above. The DWLOC represents a maximum 
concentration of a chemical in drinking water at or below which 
aggregate exposure will not exceed EPA's level of concern. In 
considering non-dietary exposure, EPA used the residential exposure 
estimate for children and applied it to all population subgroups. As 
previously noted, this estimate is considered to be highly conservative 
for children. Since adults are not expected to have non-dietary oral 
exposure to 1,2,4-triazole and that pathway makes up the majority of 
the residential exposure estimate for

[[Page 11579]]

children, application of that exposure estimate to adults is considered 
to be extremely conservative. Residential exposure is expected to occur 
for short-term and/or intermediate-term durations, and therefore is not 
a component in the acute or chronic aggregate exposure assessment. In 
order to assess aggregate short-term and intermediate-term exposure, 
EPA combined the residential exposure estimate and the background level 
of exposure to free triazole via food. Less than 1% of lawns in the 
U.S. are expected to be treated with triazole fungicides, so the 
likelihood of co-occurring dietary and residential exposures is very 
low.
    With the exception of the acute DWLOCs for infants and children 1-6 
years, all DWLOCs are greater than the largest EEC (surface water 
estimate from use on turf), indicating that aggregate exposures are not 
likely to exceed EPA's level of concern. Although the acute DWLOCs for 
infants and children 1-6 years indicate that aggregate exposure may 
exceed the aPAD of 0.015 mg/kg/day, EPA does not believe this to be the 
case due to the extremely conservative nature of the overall assessment 
(highest-tolerance level residues, 100% crop treated, 77% in vivo 
conversion factor). Furthermore, the drinking water monitoring data 
from the Pesticide Data Program found no detectable residues of either 
free triazole or parent triazole-derivative fungicide in its 
preliminary 2004 dataset, indicating that neither parent compounds nor 
1,2,4-triazole are likely to occur in drinking water. For all exposure 
durations and population subgroups, EPA does not expect aggregate 
exposures to 1,2,4-triazole to exceed its level of concern.
    The Agency is planning to conduct a more sophisticated human health 
assessment in early 2005 following submission and review of the ongoing 
toxicology and residue chemistry studies for 1,2,4-triazole.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of the 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 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.
    2. Prenatal and postnatal sensitivity. There are no data gaps for 
the assessment of the effects of fenbuconazole following in utero and/
or postnatal exposure; a developmental neurotoxicity study is not 
required. There is no indication of quantitative or qualitative 
increased susceptibility of rats or rabbits to in utero and/or 
postnatal exposure to fenbuconazole.
    3. Conclusion. There is a complete toxicity data base for 
fenbuconazole and exposure data are complete or are estimated based on 
data that reasonably accounts for potential exposures. The FQPA Safety 
Factor (SF) could be removed (i.e., reduced to 1X) in assessing the 
risk posed by fenbuconazole for several reasons:
    (i) There are no data gaps for the assessment of the effects of 
fenbuconazole following in utero and/or postnatal exposure; a 
developmental neurotoxicity study is not required.
    (ii) There is no indication of quantitative or qualitative 
increased susceptibility of rats or rabbits to in utero and/or 
postnatal exposure to fenbuconazole.
    (iii) The dietary food exposure assessment utilizes conservative 
assumptions (tolerance level residues) with respect to residues in 
food. Although some %CT information was used for the chronic dietary 
food exposure assessment, 100% CT was assumed for the acute assessment. 
Together, these assumptions result in high-end estimates of dietary 
exposure and risk.
    (iv) The dietary drinking water assessment (Tier 1 estimates) 
utilizes values generated by model and associated modeling parameters 
which are designed to provide conservative, health protective, high-end 
estimates of water concentrations;
    (v) At this time, there are no registered residential uses for 
fenbuconazole; therefore, this type of exposure to infants and children 
is not expected.

E. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates DWLOCs 
which are used as a point of comparison against the model estimates of 
a pesticide's concentration in water (EECs). DWLOC values are not 
regulatory standards for drinking water. DWLOCs are theoretical upper 
limits on a pesticide's concentration in drinking water in light of 
total aggregate exposure to a pesticide in food and residential uses. 
In calculating a DWLOC, the Agency determines how much of the 
acceptable exposure (i.e., the PAD) is available for exposure through 
drinking water (e.g., allowable chronic water exposure (mg/kg/day) = 
cPAD - (average food + residential exposure). This allowable exposure 
through drinking water is used to calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the USEPA Office of Water are used to calculate 
DWLOCs: 2 Liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 
1L/10 kg (child). Default body weights and drinking water consumption 
values vary on an individual basis. This variation will be taken into 
account in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
Acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and ground water are less than the 
calculated DWLOCs, EPA concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which EPA has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because EPA considers the aggregate risk resulting from 
multiple exposure pathways associated with a pesticide's uses, levels 
of comparison in drinking water may vary as those uses change. If new 
uses are added in the future, EPA will reassess the potential impacts 
of residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food to 
fenbuconazole will occupy 0.9% of the aPAD for females 13 years and 
older, the only population subgroup for which an acute endpoint was 
identified. After calculating DWLOCs and comparing them to the EECs for 
surface water and ground water, EPA does not expect the aggregate 
exposure to exceed 100% of the aPAD, as shown in Table 3 of this unit:

[[Page 11580]]



                     Table 3.--Aggregate Risk Assessment for Acute Exposure to Fenbuconazole
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                 aPAD (mg/      % aPAD     Water EEC    Water EEC   Acute DWLOC
                                                     kg)         (Food)       (ppb)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
Females 13 - 49 years old                                0.3          0.9         14.1        0.005        8,900
----------------------------------------------------------------------------------------------------------------

    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
fenbuconazole from food will utilize 0.3% of the cPAD for the U.S. 
population, 1.3% of the cPAD for all infants, and 1.0% of the cPAD for 
children 1 to 2 years old. There are no residential uses for 
fenbuconazole that result in chronic residential exposure to 
fenbuconazole. After calculating DWLOCs and comparing them to the EECs 
for surface water and ground water, EPA does not expect the aggregate 
exposure to exceed 100% of the cPAD, as shown in Table 4 of this unit:

             Table 4.-- Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Fenbuconazole
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/     %cPAD      Water EEC    Water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                         0.03          0.3          7.3        0.005        1,000
----------------------------------------------------------------------------------------
All infants                                             0.03          1.3          7.3        0.005          300
----------------------------------------------------------------------------------------
Children 1 - 2 years old                                0.03          1.0          7.3        0.005          300
----------------------------------------------------------------------------------------------------------------

    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).
    Fenbuconazole 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).
    Fenbuconazole 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. Based on the chronic 
dietary (food) exposure and using default body weights and water 
consumption figures, DWLOC for cancer risk were calculated. To 
calculate the DWLOC, the chronic dietary food exposure for the overall 
U.S. population was subtracted from the exposure required to achieve a 
one in one million cancer risk (1 x 10-\6\). Under FFDCA 
section 408, pesticides posing a negligible cancer risk can qualify as 
meeting section 408's reasonable certainty of no harm safety standard. 
EPA has traditionally interpreted a negligible cancer risk as a cancer 
risk in the range of a one in one million risk. Risks as high as three 
in one million have been regarded as in the range of one in one 
million. A value of 1 x 10-\6\ was used in calculating the 
DWLOC for fenbuconazole as a conservative, first-tier cancer risk 
assessment. The exposure required to achieve negligible risk is 
calculatedas 1 x 10-\6\ / Q1* 0.00359 (mg/kg/
day)-\1\. For cancer risk exposure, based on an adult body 
weight of 70 kg and 2L consumption of water per day, the estimated 
cancer DWLOC is 6.3 ppb for the U.S. population. EFED's 30-year average 
EEC of 5.9 ppb is lower than the cancer DWLOCs for the U.S. population. 
Therefore, the Agency concludes with reasonable certainty that, the 
aggregate cancer risk for fenbuconazole does not exceed the negligible 
risk standard (i.e., will not result in a cancer risk of greater than 
the range of 1 x 10-\6\). The process is illustrated in 
Table 5.

               Table 5.--Aggregate Risk Assessment for Chronic (Cancer) Exposure to Fenbuconazole
----------------------------------------------------------------------------------------------------------------
                                                                                          Chronic
                                                  Negligible                 Surface       Ground      Chronic
              Population Subgroup                Exposure mg/ %PAD (Food)   Water EEC    Water EEC   DWLOC (ppb)
                                                    kg/day                    (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                     0.000279          0.3          5.9        0.005          6.3
----------------------------------------------------------------------------------------------------------------

    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 fenbuconazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate analytical method for fenbuconazole in or on plants was 
submitted for inclusion in the Pesticide Analytical Manual Vol. 2 (PAM 
II).

B. International Residue Limits

    There are Codex maximum residues levels (MRLs) expressed as 
fenbuconazole (fat-soluble) in milk, cattle meat, liver, kidney, and 
fat, all at 0.05 ppm (limit of quantitation, LOQ). Since the MRLs 
levels are based on different residue definitions and LOQs

[[Page 11581]]

than that of U.S. registrations, international harmonization is not 
feasible.

C. Response to Comments

    A commenter raised several objections to the extension of time-
limited tolerances for fenbuconzaole: (1) Complete data should be in 
before any approval is given by EPA; further, the Agency should not 
rely on limited evidence; (2) a 4-hour toxicity test is not a fair 
amount of time to test anything; (3) testing conducted on animals has 
absolutely no validity and is cruel to the test animals; and (4) the 
DEEM\TM\ software is not suitable for evaluating risk.
    These points will be addressed in turn.
    1. Missing data/limited evidence. The commenter's mention of 
limited evidence appears to be a reference to the cancer potential for 
febuconazole. The carcinogenicity testing performed on fenbuconazole is 
complete and meets Agency scientific standards; however, the results of 
these tests are limited in that fenbuconazole does not appear to be a 
strong carcinogen. This evidence was taken into account in EPA's risk 
assessment and in making the safety determination. To the extent the 
commenter is concerned with the fact that there is limited information 
regarding 1,2,4-triazole, EPA would note that it more than compensated 
for the data limitations with regard to that chemical by making 
extremely conservative (i.e., health-protective) assumptions in 
assessing its risk.
    2. 4-Hour toxicity test. The Agency does not agree that the 
toxicity of pesticides can be judged by some undefined 4-hour toxicity 
test. Testing requirements for pesticides have been developed over many 
years following extensive review by the FIFRA Science Advisory Panel 
and many other scientific experts and groups, as well as exhaustive 
notice and comment rulemaking procedures. This comment is frivolous.
    3. Animal testing. This commenter's objections to animal testing 
have been addressed in prior rulemaking documents. See 69 FR 63083, 
October 29, 2004.
    4. DEEM\TM\ software. The commenter provides no basis for claiming 
that the DEEM\TM\ is unsuitable for risk assessment. For this reason 
alone, the comment is insignificant. EPA would note, however, that the 
DEEM\TM\ software has been thoroughly tested by the Agency and has been 
reviewed by an independent body of technical experts, the FIFRA 
Scientific Advisory Panel, and found to be suitable for evaluating 
risks to pesticide residues on food. The results of that review may be 
found athttp://www.epa.gov/scipoly/sap/2000/ february/
partialfinalreport06292000.pdf.

D. Conditions

    Time-limited tolerances were originally proposed for fenbuconazole 
because of several conditions of registration, namely the submission of 
the following items. Five additional studies had to be submitted: (1) 
Fish life cycle, (2) growth and reproduction of aquatic plants, (3) 
droplet size spectrum, (4) drift field evaluation, and (5) 49-month 
storage stability study. Several corrections to the labels were 
required. Mitigation measures to address chronic non-target organism 
toxicity concerns had to be identified and submitted. Production of the 
Indar 75 WSP product could not exceed 38,000 lb (28,500 lb active 
ingredient) for each year of conditional registration and information 
on its production had to be submitted for the first federal fiscal year 
during which fenbuconazole was registered for use on stone fruits and 
pecans. Production information had to be submitted for the Enable 2F 
product (EPA Registration Number 62719-416) for the first federal 
fiscal year during which this product was registered for use on pecans. 
The company has subsequently submitted studies, information, and 
corrected labels, and participated in task forces, intended to satisfy 
all these condition-of-registration requirements. All such submissions 
that have been reviewed have been found to satisfy the appropriate 
registration condition. However, the establishment of permanent 
tolerances for fenbuconazole depends upon the resolution of recent 
questions the Agency has raised regarding the toxicity of 1,2,4-
triazole, triazolylalanine, and triazolyl acetic acid, metabolites 
common to the triazole class of fungicides. New data to address the 
Agency's questions about these compounds is being generated and will be 
reviewed by the Agency. However, the Agency has decided to extend the 
time-limited tolerances until such data are reviewed and the questions 
about 1,2,4-triazole, triazolylalanine, and triazolyl acetic acid have 
been resolved.

V. Conclusion

    Therefore, the tolerance is established for the combined residues 
of fenbuconazole, [alpha-[2-(4-chlorophenyl)-ethyl]-alpha-phenyl-3-(1H-
1,2,4-triazole)-1-propanenitrile] and its metabolites cis- andtrans-5-
(4-chlorophenyl)-dihydro-3-phenyl-3-(1H-1,2,4-triazole-1-ylmethyl)-2-
3H-furanone, in or on banana (whole fruit) at 0.3 ppm; fruit, stone, 
group 12 (except plum, prune) at 2.0 ppm; pecan at 0.1 ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made. 
The new section 408(g) of the FFDCA provides essentially the same 
process for persons to ``object'' to a regulation for an exemption from 
the requirement of a tolerance issued by EPA under new section 408(d), 
as was provided in the old sections 408 and 409 of the FFDCA. However, 
the period for filing objections is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2004-0410 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 May 9, 
2005.
     1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900L),

[[Page 11582]]

Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Suite 350, 1099 14th St., NW., 
Washington, DC 20005. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
    2. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in ADDRESSES. Mail your 
copies, identified by docket ID number OPP-2004-0410, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in ADDRESSES. You may also send an electronic copy of 
your request via e-mail to: [email protected]. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of the 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does 
not contain any information collections subject to OMB approval under 
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose 
any enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 
104--4). Nor does it require any special considerations under Executive 
Order 12898, entitled Federal Actions to Address Environmental Justice 
in Minority Populations and Low-Income Populations (59 FR 7629, 
February 16, 1994); or OMB review or any Agency action under Executive 
Order 13045, entitled Protection of Children from Environmental Health 
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does 
not involve any technical standards that would require Agency 
consideration of voluntary consensus standards pursuant to section 
12(d) of the National Technology Transfer and Advancement Act of 1995 
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under section 408(d) of the FFDCA, such as the 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, entitledFederalism 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the development of regulatory policies 
that have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of the FFDCA. For these same reasons, the Agency 
has determined that this rule does not have any ``tribal implications'' 
as described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
Order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

VIII. 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.



[[Page 11583]]


    Dated:February 18, 2005
Betty Shackleford,
Acting Director, Registration Division, 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 180.480 is amended by revising the table in paragraph (a)(1) 
to read as follows:


Sec.  180.480   Fenbuconaozle; tolerances for residues.

    (a) General. * * *

------------------------------------------------------------------------
                                                             Expiration/
                   Commodity                     Parts per    revocation
                                                  million        date
------------------------------------------------------------------------
Banana (whole fruit)..........................          0.3     12/31/08
Fruit, stone, group 12, except plums and                2.0     12/31/08
 prunes.......................................
Pecans........................................          0.1     12/31/08
------------------------------------------------------------------------

* * * * *

FR Doc. 05-4474 Filed 3-8-05; 8:45 am
BILLING CODE 6560-50-S