Flumioxazin (Valent). Aug 25, 2004. Pesticide tolerances. Final Rule. Federal Register.

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Flumioxazin (Valent). August 25, 2004. Pesticide Tolerances. Final Rule. Federal Register.

http://www.epa.gov/fedrgstr/EPA-PEST/2004/August/Day-25/p19034.htm

[Federal Register: August 25, 2004 (Volume 69, Number 164)]
[Rules and Regulations]
[Page 52192-52198]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25au04-11]
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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:
Miller.Joanne@epamail.epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
• Crop production (NAICS 111), e.g., agricultural workers;
greenhouse, nursery, and floriculture workers; farmers.
• Animal production (NAICS 112), e.g., cattle ranchers and
farmers, dairy cattle farmers, livestock farmers.
• Food manufacturing (NAICS 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS 32532), e.g., agricultural
workers; commercial applicators; farmers; greenhouse, nursery, and
floriculture workers; residential users.
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Access Electronic Copies of this Document 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 part180 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

Exposure Scenario Dose Used in Risk Assessment, Interspecies and Intraspecies and any Traditional UF Special FQPA SF and LOC for Risk Assessment Study and Toxicological Effects

Acute dietary (Females 13-49 years of age) NOAEL = 3 milligrams/ kilogram (mg/kg)/day
aRfD = 0.03 mg/kg/day Special FQPA SF = 1
aPAD = aRfD / FQPA SF .= 0.03 mg/kg/day Oral developmental and supplemental prenatal studies (rat) LOAEL = 10 mg/kg/day
based on cardiovascular effects (especially ventricular septal defects in fetuses)

Acute dietary
(General population including infants
and children) An endpoint attributable to a single dose (exposure) was not identified
from the available studies, including the developmental toxicity studies
in rats and rabbits.

Chronic dietary (All populations) NOAEL= 2 mg/kg/day
UF = 100
cRfD = 0.02 mg/kg/day Special FQPA SF = 1
cPAD =.cRfD / FQPA SF = 0.02 mg/kg/day 2-year chronic/ carcinogenicity study (rat)
LOAEL = 18 mg/kg/day based on increased chronic nephropathy in males and decreased hematological
parameters in females
(Hgb, MCV, MCH and
MCHC)

Cancer
(Oral, dermal, inhalation) Not likely to be a carcinogen for humans based on the lack of
carcinogenicity in a 2-year rat study, an 18-month mouse study and a
battery of mutagenic studies.

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

Population Subgroup aPAD (mg/kg) % aPAD (Food) Surface Water EEC / (ppb) Ground Water EEC / (ppb) Acute DWLOC / (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

Population Subgroup cPAD (mg/kg/day) cPAD/mg/ kg//day/ (Food) Surface Water EEC / (ppb) Ground Water EEC / (ppb) Chronic 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: residuemethods@epa.gov.
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: opp-docket@epa.gov. 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.
• Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
• 1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
• 2. Section 180.568 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

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

Population Subgroup	aPAD (mg/kg)	% aPAD (Food)	Surface Water EEC / (ppb)	Ground Water EEC / (ppb)	Acute DWLOC / (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:

Population Subgroup	cPAD (mg/kg/day)	cPAD/mg/ kg//day/ (Food)	Surface Water EEC / (ppb)	Ground Water EEC / (ppb)	Chronic 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