[Federal Register Volume 69, Number 164 (Wednesday, August 25, 2004)]
[Rules and Regulations]
[Pages 52192-52198]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-19034]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0212; FRL-7369-9]


Flumioxazin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
flumioxazin in or on almond, garlic, grape, onion, peppermint, 
pistachio, shallot, spearmint, sugarcane, and tuberous/corm vegetables 
(Subgroup 1C). Valent U.S.A. Corporation requested this tolerance under 
the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the 
Food Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective August 25, 2004. Objections and 
requests for hearings must be received on or before October 25, 2004.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
Identification (ID) number OPP-2004-0212. All documents in the docket 
are listed in the EDOCKET index at http://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 South 
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: Joanne I. Miller, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-6224; 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 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 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

[[Page 52193]]

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/.

II. Background and Statutory Findings

    In the Federal Register of December 31, 2002 (67 FR 79918) (FRL-
7285-6), and March 17, 2004 (69 FR 12683) (FRL-7346-8), 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 1F6296 and 0F6171) by 
Valent U.S.A. Corporation, 1333 North California Boulevard, Suite 600, 
Walnut Creek, CA 94596-8025 and pesticide petitions (PP 3E6777, 3E6788 
and 3E6779) by Interregional Research Project Number 4 (IR-4), 681 U.S. 
Highway 1 South, North Brunswick, NJ 08902-3390. The notices 
included a summary of the petitions prepared by Valent U.S.A. 
Corporation, the registrant, and IR-4. There were no comments received 
in response to the notices of filing.
    The petitions requested that 40 CFR 180.568 be amended by 
establishing tolerances for residues of the herbicide flumioxazin, 2-
[7-fluoro-3,4-dihydro-3-oxo-4-(2-propynyl)-2H-1,4-benzoxazin-6-yl]-
4,5,6,7-tetrahydro-1H-isoindole-1,3(2H)-dione, in or on the raw 
agricultural commodities grape at 0.02 parts per million (ppm), almonds 
at 0.02 ppm, pistachios at 0.02, almond, hulls at 0.70 ppm (1F6296), 
sugarcane at 0.20 ppm (0F6171), peppermint, tops; and spearmint, tops 
at 0.04 ppm (3E6777), onion, dry bulb; garlic, bulb; and shallot, bulb 
at 0.02 ppm (3E6788), vegetable, tuberous and corm subgroup 1C at 0.02 
ppm (3E6779). The proposed tolerances were corrected to conform to the 
Food and Feed Commodity Vocabulary database (http://www.epa.gov/pesticides/foodfeed/) to read as follows: Grape at 0.02 ppm, almond 
(nutmeat) at 0.02 ppm, almond (hulls) at 0.70 ppm, pistachio at 0.02 
ppm, onion (dry bulb) at 0.02 ppm, garlic (bulb) at 0.02 ppm, shallot 
(bulb) at 0.02 ppm, tuberous/corm vegetables (Subgroup 1C) at 0.02 ppm, 
sugarcane (cane) at 0.20 ppm, peppermint (tops) at 0.04 ppm, and 
spearmint (tops) at 0.04 ppm.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish tolerances 
(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 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 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 flumioxazin, 2-[7-
fluoro-3,4-dihydro-3-oxo-4-(2-propynyl)-2H-1,4-benzoxazin-6-yl]-
4,5,6,7-tetrahydro-1H-isoindole-1,3(2H)-dione on grape at 0.02 ppm, 
almond (nutmeat) at 0.02 ppm, almond (hulls) at 0.70 ppm, pistachio at 
0.02 ppm, onion (dry bulb) at 0.02 ppm, garlic (bulb) at 0.02 ppm, 
shallot (bulb) at 0.02 ppm, tuberous/corm vegetables (Subgroup 1C) at 
0.02 ppm, sugarcane (cane) at 0.20 ppm, peppermint (tops) at 0.04 ppm, 
and spearmint (tops) at 0.04 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 flumioxazin are 
discussed in a March 31, 2004 Federal Register document (69 FR 16823) 
(FRL-7351-2).

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.
    Three other types of safety or uncertainty factors may be used: 
``Traditional UFs''; the ``special FQPA safety factor''; and the 
``default FQPA safety factor.'' By the term ``traditional uncertainty 
factor,'' EPA is referring to those additional UFs used prior to FQPA 
passage to account for database deficiencies. These traditional UFs 
have been incorporated by the FQPA into the additional safety factor 
(SF) for the protection of infants and children. The term ``special 
FQPA SF'' refers to those safety factors that are deemed necessary for 
the protection of infants and children primarily as a result of the 
FQPA. The ``default FQPA SF'' is the additional 10X SF that is mandated 
by the statute unless it is decided that there are reliable data to 
choose a different additional factor (potentially a traditional UF or a 
special FQPA SF).
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (aRfD or cRfD) where 
the RfD is equal to the NOAEL divided by an UF of 100 to account for 
interspecies and intraspecies differences and any traditional UFs 
deemed appropriate (RfD = NOAEL/UF). Where a special FQPA SF or the 
default FQPA SF is used, 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 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

[[Page 52194]]

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). An example of how such a probability risk is expressed 
would be to describe the risk as one in one hundred thousand (1 x 
10-\5\), one in a million (1 x 10-\6\), or one in 
ten million (1 x 10-\7\). 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 flumioxazin used for 
human risk assessment is shown in Table 1 of this unit:

     Table 1.--Summary of Toxicological Dose and Endpoints for flumioxazin for Use in Human Risk Assessment
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                                          Dose Used in Risk
                                             Assessment,
          Exposure Scenario                Interspecies and     Special FQPA SF and LOC  Study and Toxicological
                                         Intraspecies and any     for Risk Assessment            Effects
                                            Traditional UF
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Acute dietary                          NOAEL = 3 milligrams/    Special FQPA SF = 1      Oral developmental and
(Females 13-49 years of age).........   kilogram (mg/kg)/day    aPAD = aRfD / FQPA SF..   supplemental prenatal
                                       aRfD = 0.03 mg/kg/day..  = 0.03 mg/kg/day.......   studies (rat)
                                                                                         LOAEL = 10 mg/kg/day
                                                                                          based on
                                                                                          cardiovascular effects
                                                                                          (especially
                                                                                          ventricular septal
                                                                                          defects in fetuses)
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Acute dietary                           An endpoint attributable to a single dose (exposure) was not identified
(General population including infants   from the available studies, including the developmental toxicity studies
 and children).                                                   in rats and rabbits.
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Chronic dietary (All populations)      NOAEL= 2 mg/kg/day       Special FQPA SF = 1      2-year chronic/
                                       UF = 100...............  cPAD =.................   carcinogenicity study
                                       cRfD = 0.02 mg/kg/day..  cRfD / FQPA SF.........   (rat)
                                                                = 0.02 mg/kg/day.......  LOAEL = 18 mg/kg/day
                                                                                          based on increased
                                                                                          chronic nephropathy in
                                                                                          males and decreased
                                                                                          hematological
                                                                                          parameters in females
                                                                                          (Hgb, MCV, MCH and
                                                                                          MCHC)
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Cancer                                       Not likely to be a carcinogen for humans based on the lack of
(Oral, dermal, inhalation)...........     carcinogenicity in a 2-year rat study, an 18-month mouse study and a
                                                              battery of mutagenic studies.
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C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.568) for the residues of flumioxazin, in or on 
cotton, peanuts and soybean seed. No secondary residues are expected in 
meat, milk, poultry or eggs. Risk assessments were conducted by EPA to 
assess dietary exposures from flumioxazin 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.
    In conducting the acute dietary risk assessment, EPA used the 
Dietary Exposure Evaluation Model software with the Food Commodity 
Intake Database (DEEM-FCID\TM\), 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: For the acute analyses, tolerance-level 
residues were assumed for all food commodities with current or proposed 
flumioxazin tolerances, and it was assumed that all of the crops 
included in the analysis were treated. Percent Crop Treated (PCT) and/
or anticipated residues were not used in the acute risk assessment.
    ii. Chronic exposure. In conducting the chronic dietary risk 
assessment, EPA used the DEEM-FCID\TM\, 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: For the chronic analyses, tolerance-level residues were 
assumed for all food commodities with current or proposed flumioxazin 
tolerances, and it was assumed that all of the crops included in the 
analysis were treated. PCT and/or anticipated residues were not used in 
the chronic risk assessment.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for flumioxazin and its 
degradates (482-HA and APF) 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 flumioxazin and its 
degradates (482-HA and APF).
    The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) or 
the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS), to produce estimates of pesticide concentrations in an index 
reservoir. The screening concentration in ground water (SCI-GROW) model 
is used to predict pesticide concentrations in shallow ground water. 
For a screening-level assessment for surface water EPA will use FIRST 
(a Tier 1 model) before using PRZM/EXAMS (a Tier 2 model). The FIRST 
model is a subset of the PRZM/EXAMS model that uses a specific high-end 
runoff scenario for pesticides. Both FIRST and PRZM/EXAMS incorporate 
an index reservoir environment, and both models include a percent crop 
area factor as an adjustment to account for the maximum

[[Page 52195]]

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 screen for sorting out pesticides for which it is 
unlikely that drinking water concentrations would exceed human health 
LOC.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs), which are the model estimates of a 
pesticide's concentration in water. EECs derived from these models are 
used to quantify drinking water exposure and risk as a %RfD or %PAD. 
Instead drinking water levels of comparison (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 flumioxazin they are 
further discussed in Unit III.E.
    Based on the FIRST and SCI-GROW models, the EECs of flumioxazin and 
its degradates (482-HA and APF) for acute exposures are estimated to be 
a total of 34 parts per billion (ppb) for surface water and 48 ppb for 
ground water. The EECs for chronic exposures are estimated to be a 
total of 18 ppb for surface water and 48 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).
    Flumioxazin is not registered for use on any sites that would 
result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of 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, EPA has not made 
a common mechanism of toxicity finding as to flumioxazin and any other 
substances. Flumioxazin 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 flumioxazin 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 the cumulative effects of such chemicals, see 
the policy statements released by EPA's Office of Pesticide Programs 
concerning common mechanism determinations and procedures for 
cumulating effects from substances found to have a common mechanism on 
EPA's web site at http://www.epa.gov/pesticides/cumulative/.

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 database 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 SF 
value based on the use of traditional UFs and/or special FQPA SFs, as 
appropriate.
    2. Prenatal and postnatal sensitivity. Although increased prenatal 
and postnatal quantitative susceptibility was seen in rats, it was 
concluded that there is low concern and no residual uncertainties for 
prenatal and/or postnatal toxicity because:
    i. Developmental toxicity NOAELs/LOAELs are well characterized 
after oral and dermal exposure.
    ii. Offspring toxicity NOAEL/LOAEL are well characterized.
    iii. There is a well-defined dose-response curve for the 
cardiovascular effects seen following oral exposure (i.e. critical 
period).
    iv. The endpoints of concern are used for overall risk assessments 
for appropriate route and population subgroups.
    3. Conclusion. There is a complete toxicity database for 
flumioxazin and exposure data are complete or are estimated based on 
data that reasonably accounts for potential exposures. EPA determined 
that the special 10X SF to protect infants and children should be 
removed. The FQPA factor is removed because developmental toxicity and 
offspring toxicity NOAELs/LOAELs are well characterized; there is a 
well-defined dose-response curve for the cardiovascular effects and the 
endpoints of concern are used for overall risk assessments are 
appropriate for the route of exposure and population subgroups.

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 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 EPA's 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

[[Page 52196]]

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 
flumioxazin will occupy less than (<) 1% of the aPAD for females 13 to 
49 years old. In addition, there is potential for acute dietary 
exposure to flumioxazin in drinking water. 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 2 of this unit:

                      Table 2.--Aggregate Risk Assessment for Acute Exposure to flumioxazin
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                 aPAD (mg/      % aPAD     Water EEC/   Water EEC/  Acute DWLOC/
                                                     kg)         (Food)       (ppb)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
Females (13-49 years)                                   0.03           <1           34           48          890
----------------------------------------------------------------------------------------------------------------

    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
flumioxazin from food will utilize < 1% of the cPAD for the U.S. 
population, < 1% of the cPAD for all infant and children 
subpopulations. There are no residential uses for flumioxazin that 
result in chronic residential exposure to flumioxazin. In addition, 
there is potential for chronic dietary exposure to flumioxazin in 
drinking water. 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 3 of this unit:

              Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to flumioxazin
----------------------------------------------------------------------------------------------------------------
                                                               % cPAD/mg/    Surface       Ground
              Population Subgroup                cPAD (mg/kg/   kg//day/    Water EEC/   Water EEC/    Chronic
                                                     day)        (Food)       (ppb)        (ppb)     DWLOC/(ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                         0.02           <1           18           48          700
--------------------------------------------------------------
All infants (<1 year)                                   0.02           <1           18           48          200
--------------------------------------------------------------
Children (1-2 years)                                    0.02            2           18           48          200
--------------------------------------------------------------
Children (3-5 years)                                    0.02            2           18           48          200
--------------------------------------------------------------
Females (13-49 years)                                   0.02           <1           18           48          600
----------------------------------------------------------------------------------------------------------------

    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).
    Flumioxazin 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 
LOC.
    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).
    Flumioxazin 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 
LOC.
    5. 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 flumioxazin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (example--gas chromotography) is 
available to enforce the tolerance expression. The method may be 
requested from: Chief, Analytical Chemistry Branch, Environmental 
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone 
number: (410) 305-2905; e-mail address: [email protected].

B. International Residue Limits

    There are no Codex, Canadian or Mexican maximum residue limits 
established for flumioxazin on grape, almond, pistachio, onion, garlic, 
shallot, tuberous/corm vegetables (Subgroup 1C), sugarcane, peppermint, 
or spearmint.

V. Conclusion

    Therefore, the tolerance is established for residues of 
flumioxazin, (2-[7-fluoro-3,4-dihydro-3-oxo-4-(2-propynyl)-2H-1,4-
benzoxazin-6-yl]-4,5,6,7-tetrahydro-1H-isoindole-1,3(2H)-dione) in or 
on grape at 0.02 ppm, almond (nutmeat) at 0.02 ppm, almond (hulls) at 
0.70 ppm, pistachio at 0.02 ppm, onion (dry bulb) at 0.02 ppm, garlic 
(bulb) at 0.02 ppm, shallot (bulb) at 0.02 ppm, tuberous/corm 
vegetables (Subgroup 1C) at 0.02 ppm, sugarcane (cane) at 0.20 ppm, 
peppermint (tops) at 0.04 ppm, and spearmint (tops) at 0.04 ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of FFDCA, as amended by 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

[[Page 52197]]

reflect the amendments made to FFDCA by FQPA, EPA will continue to use 
those procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) of 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) of FFDCA, as was provided in the old sections 
408 and 409 of 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-2004-0212 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 October 
25, 2004.
    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), 
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 14\th\ St., 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-2004-0212, 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 
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

[[Page 52198]]

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.

    Dated: August 5, 2004.
Lois Rossi,
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 180.568 is amended by alphabetically adding commodities to 
the table in paragraph (a) to read as follows:


Sec.  180.568  Flumioxazin; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Almond (hulls).............................................         0.70
Almond (nutmeat)...........................................         0.02
                                * * * * *
Garlic (bulb)..............................................         0.02
Grape......................................................         0.02
Onion (dry bulb)...........................................         0.02
                                * * * * *
Peppermint (tops)..........................................         0.04
Pistachio..................................................         0.02
Shallot (bulb).............................................         0.02
                                * * * * *
Spearmint (tops)...........................................         0.04
Sugarcane (cane)...........................................         0.20
Tuberous/corm vegetables (Subgroup 1C).....................         0.02
------------------------------------------------------------------------

* * * * *
[FR Doc. 04-19034 Filed 8-24-04; 8:45 am]
BILLING CODE 6560-50-S