[Federal Register Volume 68, Number 166 (Wednesday, August 27, 2003)]
[Rules and Regulations]
[Pages 51465-51471]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-21662]


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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: 
[email protected].

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:
    [sbull] 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 (MOEcancer = 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:[email protected].

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 [email protected], 
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: [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).

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 (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

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.

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), 346(a) and 371.

0
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