Flumioxazin. Aug 27, 2003. Peticide tolerance for emergency exemption. Federal Register.

FLUORIDE ACTION NETWORK PESTICIDE PROJECT

Flumioxazin. August 27, 2003. Pesticide tolerance for Emergency Exemption. Final Rule. Federal Register.

http://www.epa.gov/fedrgstr/EPA-PEST/2003/August/Day-27/p21662.htm

[Federal Register: August 27, 2003 (Volume 68, Number 166)]
[Rules and Regulations]
[Page 51465-51471]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27au03-13]

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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2003-0253; FRL-7319-4]

Flumioxazin; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance for
residues of flumioxazin in or on sweet potato, roots in connection with
a crisis exemption declared by the State of Louisiana. This regulation
establishes a maximum permissible level for residues of flumioxazin in
this food commodity. The tolerance will expire and is revoked on June
30, 2006.

DATES: This regulation is effective August 27, 2003. Objections and
requests for hearings, identified by docket ID number OPP-2003-0253,
must be received on or before October 27, 2003.

ADDRESSES: Written objections and hearing requests may be submitted
electronically, by mail, or through hand delivery/courier. Follow the
detailed instructions as provided in Unit VII. of the SUPPLEMENTARY
INFORMATION.

FOR FURTHER INFORMATION CONTACT: Libby Pemberton, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-9364; e-mail address:
pemberton.libby@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by this action if you a Federal or
State government agency involved in administration of environmental
quality programs. Potentially affected entities may include, but are
not limited to:
¥ Federal or State Government Entity, (NAICS 9241), i.e.,
Departments of Agriculture, Environment, etc.
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 Get Copies of This Document and Other Related Information?

1. Docket. EPA has established an official public docket for this
action under docket identification (ID) number OPP-2003-0253. The
official public docket consists of the documents specifically
referenced in this action, any public comments received, and other
information related to this action. Although a part of the official
docket, the public docket does not include Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. The official public docket is the collection of materials
that is available for public viewing at the Public Information and
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2,
1921 Jefferson Davis Hwy., 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.
2. Electronic access. 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 http://www.access.
gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html,
a beta site currently under development.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in the system, select ``search,'' then key in the
appropriate docket ID number.

II. Background and Statutory Findings

EPA, on its own initiative, in accordance with sections 408(e) and
408 (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, is establishing a tolerance 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 sweet potato, roots at 0.02 parts per million (ppm). This tolerance
will expire and is revoked on June 30, 2006. EPA will publish a
document in the Federal Register to remove the revoked tolerance from
the Code of Federal Regulations.
Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
section 18 related tolerances to set binding precedents for the
application of section 408 of the FFDCA and the new safety standard to
other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA
to establish a tolerance or an exemption from the requirement of a
tolerance on its own initiative, i.e., without having received any
petition from an outside party.
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 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. . .
.''
Section 18 of the FIFRA authorizes EPA to exempt any Federal or
State agency from any provision of FIFRA, if EPA determines that
``emergency conditions exist which require such exemption.'' This
provision was not amended by the Food Quality Protection Act of 1996
(FQPA). EPA has established regulations governing such emergency
exemptions in 40 CFR part 166.

[[Page 51466]]

III. Emergency Exemption for Flumioxazin on Sweet Potato, Roots and
FFDCA Tolerances

Ineffectiveness of registered alternatives in controlling sedges,
pigweeds, and other broadleaf weeds has allowed these weeds to flourish
and become more problematic each year. Louisiana has declared a crisis
exemption under FIFRA section 18 for the use of flumioxazin on sweet
potato, roots for control of certain broadleaf weeds.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of flumioxazin in or on sweet
potato, roots. In doing so, EPA considered the safety standard in
section 408(b)(2) of the FFDCA, and EPA decided that the necessary
tolerance under section 408(l)(6) of the FFDCA would be consistent with
the safety standard and with FIFRA section 18. Consistent with the need
to move quickly on the emergency exemption in order to address an
urgent non-routine situation and to ensure that the resulting food is
safe and lawful, EPA is issuing this tolerance without notice and
opportunity for public comment as provided in section 408(l)(6) of the
FFDCA. Although this tolerance will expire and is revoked on June 30,
2006, under section 408(l)(5) of the FFDCA, residues of the pesticide
not in excess of the amounts specified in the tolerance remaining in or
on sweet potato, roots after that date will not be unlawful, provided
the pesticide is applied in a manner that was lawful under FIFRA, and
the residues do not exceed a level that was authorized by this
tolerance at the time of that application. EPA will take action to
revoke this tolerance earlier if any experience with, scientific data
on, or other relevant information on this pesticide indicate that the
residues are not safe.
Because this tolerance is being approved under emergency
conditions, EPA has not made any decisions about whether flumioxazin
meets EPA's registration requirements for use on sweet potato, roots or
whether a permanent tolerance for this use would be appropriate. Under
these circumstances, EPA does not believe that this tolerance serves as
a basis for registration of flumioxazin by a State for special local
needs under FIFRA section 24(c). Nor does this tolerance serve as the
basis for any State other than Louisiana to use this pesticide on this
crop under section 18 of FIFRA without following all provisions of
EPA's regulations implementing FIFRA section 18 as identified in 40 CFR
part 166. For additional information regarding the emergency exemption
for flumioxazin, contact the Agency's Registration Division at the
address provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

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) .
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
flumioxazin and to make a determination on aggregate exposure,
consistent with section 408(b)(2) of the FFDCA, for a time-limited
tolerance for residues of flumioxazin in or on sweet potato, roots at
0.02 ppm. EPA's assessment of the dietary exposures and risks
associated with establishing the tolerance follows.

A. 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 endpoint. 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 SF.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the level of concern (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 as 1 x10-6 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 (MOE_cancer = point of
departure/exposures) is calculated. A summary of the toxicological
endpoints for flumioxazin used for human risk assessment is shown in
the following Table 1:

[[Page 51467]]

Table 1.--Summary of Toxicological Doses and Endpoints for Flumioxazin
----------------------------------------------------------------------------------------------------------------
HIARC/FQPA
Endpoint Dose (mg/kg/day) determination Conclusion
----------------------------------------------------------------------------------------------------------------
Acute Dietary NOAEL = 3.0 Cardiac effects This risk assessment is
UF = 100............... (interventricular required for the
septal defects) were population subgroup
seen in the oral Females 13-50.
developmental and Acute RfD=0.03 mg/kg/
supplemental prenatal day
studies in rats.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary NOAEL = 2 Kidney effects were This risk assessment is
UF = 100............... seen in males and required. Chronic RfD
anemia was seen in =0.02 mg/kg/day.
females in the 2-year
toxicity study in
rats.
----------------------------------------------------------------------------------------------------------------
FQPA Safety Factor NA Safety factor was 10x Safety factor was
retained because (1) retained
there was evidence of aPAD=0.003 mg/kg/dy
increased cPAD=0.002 mg/kg/dy
susceptibility of
fetuses exposed to
flumioxazin by both
the oral and dermal
route in the prenatal
developmental toxicity
studies in rats, (2)
there was evidence of
increased
susceptibility of
young animals exposed
to flumioxazin in the
2-generation
reproduction toxicity
in rats, and (3) there
is concern for the
severity of the
effects in fetuses and
young animals when
compared to the
maternal or parental
animals.
----------------------------------------------------------------------------------------------------------------
Carcinogenicity NA The HIARC determined A cancer risk
that flumioxazin is assessment is not
``not likely'' to be a required.
human carcinogen
(HIARC Memo, In
Review).
----------------------------------------------------------------------------------------------------------------

B. 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
peanuts and soybean seed. 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 one day
or single exposure. The Dietary Exposure Evaluation Model (DEEM[reg])
analysis evaluated the individual food consumption as reported by
respondents in the 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 this acute analysis the
assumption was made that 100% of the crops with flumioxazin tolerances
are treated with flumioxazin. In addition, the assumption was made that
all commodities contain tolerance level residues when consumed, with
the exception of those with default processing factors. Default
processing factors were used for peanuts-butter (1.89x) and for
soybeans-sprouted seeds (0.33x). As the exposure and risk estimates
were low, no further refinements were made to this analysis.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment the DEEM[reg]
analysis evaluated the individual food
consumption 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 this chronic analysis the assumption was made that
100% of the crops with flumioxazin tolerances are treated with
flumioxazin. In addition, the assumption was made that all commodities
contain tolerance level residues when consumed, with the exception of
those with default processing factors. Default processing factors were
used for peanuts-butter (1.89x) and for soybeans-sprouted seeds
(0.33x). As the exposure and risk estimates were low, no further
refinements were made to this analysis.
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 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.
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
Screening Concentration in Ground Water Modeling System (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 percent of the reference dose or
percent of the population adjusted dose (%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

[[Page 51468]]

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 the aggregate risk sections below.
The hydrolysis study for flumioxazin indicates that flumioxazin
forms the metabolite 482-HA, which can further hydrolyze to metabolites
APF and THPA. The rates of the two hydrolytic reactions are very pH
dependent, but the parent is not very stable at any likely
environmental pH. Additional data indicated that THPA and APF are
likely to be very mobile. Although THPA can comprise a major portion of
the total residue in water, it does not possess the phenyl ring and is
thus considered significantly less toxic than parent, APF, and 482-HA,
thus THPA needs not be included in the residue of concern for drinking
water. Therefore, parent flumioxazin and the metabolites 482-HA and APF
are the residues of concern in drinking water.
Based on the GENEEC and SCI-GROW models the EECs of flumioxazin for
acute exposures are estimated to be 2.4 parts per billion (ppb) for
surface water and 6.3 ppb for ground water. The EECs for chronic
exposures are estimated to be 0.67 ppb for surface water and 6.3 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 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.''
EPA does not have, at this time, available data to determine
whether flumioxazin has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
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 final rule
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

C. 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. The data for flumioxazin
indicate that there is both quantitative and qualitative evidence of
increased susceptibility to flumioxazin from prenatal or postnatal
exposures. Quantitative susceptibility is observed when the young
respond more than the adults at a given dose, and qualitative
susceptibility is observed when there is a unique biological target,
such as the developing brain, that predisposes the individual. The
quantitative and qualitative evidence of increased susceptibility is
observed with the rat fetuses to in utero exposure to flumioxazin in
the oral and dermal developmental studies. In both studies, there was
an increased incidence in fetal cardiovascular anomalies (especially
ventricular septal defects). In the oral study, no maternal effects
were seen at the highest dose tested (HDT) (30 milligrams/kilograms
(mg/kg/day)); whereas, the effects in the fetuses were observed at 10
mg/kg/day. In the dermal study, no maternal effects were noted at the
HDT (300 mg/kg/day); whereas, the effects in the fetuses were observed
at 100 mg/kg/day. Regarding the 2-generation rat reproduction study,
parental effects (red substance in vagina and increased mortality in
females as well as decreases in male and female body weights, body
weight gains, and food consumption) were noted at 18.9 mg/kg/day in
males HDT and 22.7 mg/kg/day in females HDT. Based on the results of
the study, no apparent reproduction effects were attributed to test
article administration. The effects observed regarding the offspring
were a decrease in both the number of liveborn and pup body weights at
12.7 mg/kg/day for males and 15.1 mg/kg/day for females. Therefore, it
was considered that there was both a quantitative and qualitative
increase in susceptibility.
5. Conclusion. There is a complete toxicity data base for
flumioxazin and exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures. The FQPA safety
factor (as required by the Food Quality Protection Act of August
3,1996) has been retained at 10x for all population subgroups for all
exposure durations (acute and chronic) in assessing the risk posed by
this chemical. The reasons for retaining the 10x safety factor are as
follows. First, there is evidence of increased susceptibility of the
rat fetuses to in utero exposure to flumioxazin by the oral and dermal
route in the prenatal developmental toxicity studies in rats. In
addition, there is evidence of increased susceptibility of young
animals exposed to flumioxazin in the 2-generation reproduction
toxicity study in rats. Finally, there is concern for the severity of
the effects observed in fetuses and young animals when compared to
those observed in the maternal and parental animals (dose- and
treatment-related increase in the incidence of cardiovascular
abnormalities, particularly ventricular septal defect, in the
developmental studies; and decreases in the number of live born pups
and pup body weights in the absence of parental toxicity in the
reproduction study).

D. 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 + chronic non-dietary, non-occupational
exposure)]. This allowable exposure through drinking water is used to
calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water

[[Page 51469]]

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 flumioxazin 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
flumioxazin on 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 6% of the aPAD for females 13 years and older.
In addition, despite the potential for acute dietary exposure to
flumioxazin in drinking water, after calculating DWLOCs and comparing
them to conservative model estimated environmental concentrations of
flumioxazin in surface water and ground water, EPA does not expect the
aggregate exposure to exceed 100% of the aPAD, as shown in the
following Table 2:

Table 2.--Aggregate Risk Assessment for Acute Exposure to Flumioxazin
--------------------------------------------------------------------------------------------------------------------------------------------------------
Surface water EEC Ground water EEC
Population subgroup aPAD (mg/kg) % aPAD (Food) (ppb) (ppb) Acute DWLOC (ppb)\a\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Females (13-50 years old) 0.003 4.6 2.4 6.3 86
--------------------------------------------------------------------------------------------------------------------------------------------------------
\a\ DWLOC = Drinking Water Level of Comparison = (PAD - dietary exposure) x 1,000 [mu]g/mg x body weight / consumption. Standard body weights are 70 kg
adult males, 60 kg adult females, 10 kg infants and children. Standard consumption values are 2 L/day for adults and 1 L/day for infants and children.
DWLOC values are rounded to 2 significant figures.

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 4% of the cPAD for the U.S.
population, 12% of the cPAD for children 3-5 years old, the
subpopulation at greatest exposure and 11% of the cPAD for children 1-2
years old. There are no residential uses for flumioxazin that result in
chronic residential exposure to flumioxazin. In addition, despite the
potential for chronic dietary exposure to flumioxazin in drinking
water, after calculating DWLOCs and comparing them to conservative
model estimated environmental concentrations of flumioxazin in surface
and ground water, EPA does not expect the aggregate exposure to exceed
100% of the cPAD, as shown in the following Table 3:

Table 3.--Aggregate Risk Assessment for Chronic Exposure to Flumioxazin
--------------------------------------------------------------------------------------------------------------------------------------------------------
Surface water EEC Ground water EEC
Population subgroup cPAD (mg/kg) % cPAD (Food) (ppb) (ppb) Chronic DWLOC (ppb)a
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. Population 0.002 4 2.4 6.3 68
--------------------------------------------------------------------------------------------------------------------------------------------------------
All Infants (<1 year old) 0.00 6 2.4 6.3 18
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children (1-2 years old) 0.002 11 2.4 6.3 19
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children (3-5 years old) 0.002 12 2.4 6.3 19
--------------------------------------------------------------------------------------------------------------------------------------------------------
Females (13-49 years old) 0.002 3 2.4 6.3 58
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children (6-12 years old) 0.002 9 2.4 6.3 67
--------------------------------------------------------------------------------------------------------------------------------------------------------
Youths (13-19years old) 0.002 4 2.4 6.3 68
--------------------------------------------------------------------------------------------------------------------------------------------------------
Adults (50+ ) 0.002 3 2.4 6.3 69
--------------------------------------------------------------------------------------------------------------------------------------------------------
\a\ DWLOC = Drinking Water Level of Comparison = (PAD - dietary exposure) x 1000 [mu]g/mg x body weight / consumption. Standard body weights are 70 kg
adult males, 60 kg adult females, 10 kg infants and children. Standard consumption values are 2 L/day for adults and 1 L/day for infants and children.
DWLOC values are rounded to 2 significant figures.

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 were previously addressed.
4. 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.

V. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology is available to enforce the
tolerance

[[Page 51470]]

expression. The method may be requested from: Calvin Furlow, PIRIB,
IRSD (7502C), Office of Pesticide Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460; telephone
number: (703) 305-5229; e-mail address:furlow.calvin@epa.gov.
B. International Residue Limits

There are no Codex, Canadian or Mexican maximum residue limits
established on soybeans or peanuts.

VI. 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 sweet potato, roots at 0.02 ppm.

VII. 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)
of the FFDCA, 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-2003-0253 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
27, 2003.
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 (1900C),
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 Rm. 104, Crystal Mall #2, 1921
Jefferson Davis Hwy., Arlington, VA. 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
(703) 603-0061.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VII.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.1. Mail your
copies, identified by the docket ID number OPP-2003-0253, 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 Unit I.B.1. 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).

VIII. Statutory and Executive Order Reviews

This final rule establishes a time-limited tolerance under section
408 of the FFDCA. 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

[[Page 51471]]

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 FIFRA section 18
exemption under section 408 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, 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 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 (59 FR 22951, 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.

IX. 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 19, 2003.
Debra Edwards,
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), 346(a) and 371.

¥ 2. Section 180.568 is amended by adding text to paragraph (b) to read
as follows:

Sec. 180.568 Flumioxazin; tolerances for residues.

* * * * *
(b) Section 18 emergency exemptions. Time-limited tolerances are
established for residues of the herbicide flumioxazin in connection
with the use of the pesticides under section 18 emergency exemptions
granted by EPA. The tolerances will expire and are revoked on the dates
specified in the following table.

------------------------------------------------------------------------
Parts
Commodity per Expiration/
million Revocation date
------------------------------------------------------------------------
Sweet potato, roots......................... 0.02 06/30/05
------------------------------------------------------------------------

* * * * *

[FR Doc. 03-21662 Filed 8-26-03; 8:45 am]
BILLING CODE 6560-50-S