[Federal Register: March 31, 2004 (Volume 69, Number 62)]
[Rules and Regulations]
[Page 16823-16832]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31mr04-23]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2004-0089; FRL-7351-2]
Flumioxazin; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance 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 cottonseed and cotton gin byproducts. Valent U.S.A. Corporation
requested this tolerance under the Federal Food, Drug, and Cosmetic Act
(FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA).
DATES: This regulation is effective March 31, 2004. Objections and
requests
[[Page 16824]]
for hearings, identified by docket ID number OPP-2004-0089, must be
received on or before June 1, 2004.
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 VI. of the SUPPLEMENTARY
INFORMATION.
FOR FURTHER INFORMATION CONTACT: Joanne I. Miller, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460-
0001; telephone number: (703) 305-6224; e-mail address:
Miller.Joanne@epamail.epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS 111), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS 112), e.g., cattle
ranchers and farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS 311), e.g.,
agricultural workers; farmers; greenhouse, nursery, and floriculture
workers; ranchers; pesticide applicators.
Pesticide manufacturing (NAICS 32532), e.g.,
agricultural workers; commercial applicators; farmers; greenhouse,
nursery, and floriculture workers; residential users.
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I 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-2004-0089. 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 on E-CFR Beta Site
Two at http://www.gpoaccess.gov/ecfr/. To access the OPPTS Harmonized
Guidelines referenced in this document, go directly to the guidelines
at http://www.epa.gov/opptsfrs/home/guidelin.htm/.
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
In the Federal Register of December 31, 2002 (67 FR 79918) (FRL-
7285-6), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
1F6296) by Valent U.S.A. Corporation, 1333 North California Boulevard,
Suite 600, Walnut Creek, California 94596-8025. That notice included a
summary of the petition prepared by Valent U.S.A. Corporation, the
registrant. There were no comments received in response to the notice
of filing.
The petition requested that 40 CFR 180.568 be amended by
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 cotton at 0.02
parts per million (ppm) and cotton gin byproducts at 0.60 ppm.
Section 408(b)(2)(A)(i) of 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 FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of FFDCA and a complete
description of the risk assessment process, see the final rule on
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of FFDCA, for a tolerance for residues of flumioxazin on
cottonseed at 0.02 ppm and cotton gin byproducts at 0.60 ppm. EPA's
assessment of exposures and risks associated with establishing the
tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by flumioxazin are
discussed in Table 1 of this unit as well
[[Page 16825]]
as the no observed adverse effect level (NOAEL) and the lowest observed
adverse effect level (LOAEL) from the toxicity studies reviewed.
Table 1.--Acute, Subchronic, Chronic, and Other Toxicity
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Guideline No. Study Type Results
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870.1000 Acute oral toxicity (rat) LD50 > 5,000 milligrams/kilogram (mg/kg);
no clinical signs
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870.1100 Acute dermal (rat) LD50 >2,000 mg/kg; no clinical signs
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870.1200 Acute inhalation (rat) LC50 = 3.93 mg/Liter (L)
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870.2400 Primary eye irritation - No corneal irritation; mild irritation of
rabbit iris cleared by 24 hours; mild irritation
of conjunctiva cleared by 48 hours
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870.2500 Primary skin irritation - No erythema or edema
rabbit
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870.2600 Dermal sensitization - Not a dermal sensitizer
guinea pig
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870.3100 90-Day oral toxicity-- NOAEL males = 69.7 mg/kg/day
rodents (rat) NOAEL females = 71.5 mg/kg/day
LOAEL males = 243.5 mg/kg/day
LOAEL females = 229.6 mg/kg/day based on a
decrease in MCV both sexes; increase in
platelets females only
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870.3100 90-Day oral toxicity-- NOAEL males = 65.0 mg/kg/day
rodents (rat) NOAEL females = 72.9 mg/kg/day
LOAEL males = 196.7 mg/kg/day
LOAEL females = 218.4 mg/kg/day based on
hematology changes
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870.3100 90-Day oral toxicity-- NOAEL = 429 mg/kg/day
rodents (mouse) LOAEL = 1,429 mg/kg/day based on increased
liver weight in males
----------------------------------------------------------------------------------------------------------------
870.3100 4-Week oral toxicity-- NOAEL males = 151.5 mg/kg/day
rodents (mouse) NOAEL females = 164.5 mg/kg/day
LOAEL males = 419.9 mg/kg/day
LOAEL females = 481.6 mg/kg/day based on
increased absolute and/or relative liver
weights in males and females
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870.3150 90-Day oral toxicity-- NOAEL = 10 mg/kg/day
nonrodents (dog) LOAEL = 100 mg/kg/day based on dose
dependent increase in total cholesterol,
phospholipid and alkalinephosphatase
----------------------------------------------------------------------------------------------------------------
870.3200 21-Day dermal toxicity NOAEL = 1,000 mg/kg/day (limit dose)
(rat) LOAEL = > 1,000 mg/kg/day based on no
effects
----------------------------------------------------------------------------------------------------------------
870.3700 Prenatal developmental-- Maternal NOAEL = 30 mg/kg/day highest dose
rodents (rat oral) tested (HDT)
Maternal LOAEL > 30 mg/kg/day (HDT)
Developmental NOAEL = 3 mg/kg/day
Developmental LOAEL = 10 mg/kg/day based on
cardiovascular effects (especially
ventricular septal defects)
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870.3700 Prenatal developmental-- Maternal NOAEL = 300 mg/kg/day highest dose
rodents (rat dermal) tested (HDT)
Maternal LOAEL > 300 mg/kg/day (HDT)
Developmental NOAEL = 30 mg/kg/day
Developmental LOAEL = 100 mg/kg/day based
on cardiovascular effects (especially
ventricular septal defects)
----------------------------------------------------------------------------------------------------------------
870.3700 Prenatal developmental-- Maternal NOAEL = 1,000 mg/kg/day
nonrodents (rabbit oral) Maternal LOAEL = 3,000 mg/kg/day based on
decrease in body weight and food
consumption during dosing
Developmental NOAEL = 3,000 mg/kg/day (HDT)
Developmental LOAEL mg/kg/day > 3,000 (HDT)
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[[Page 16826]]
870.3800 Reproduction and fertility Parental/Systemic NOAEL males = 12.7 mg/kg/
effects (rat) day
Parental/Systemic NOAEL females = 15.1 mg/
kg/day mg/kg/day
Parental/Systemic LOAEL males = 18.9 mg/kg/
day
Parental/Systemic LOAEL females = 22.7 mg/
kg/day based on increase in clinical signs
(red substance in vagina) and increased
female mortality as well as decreased body
weight, body weight gain and food
consumption
Reproductive NOAEL males = 18.9 mg/kg/day
(HDT)
Reproductive NOAEL females = 22.7 mg/kg/day
(HDT)
Reproductive LOAEL males > 18.9 mg/kg/day
(HDT)
Reproductive LOAEL females > 22.7 mg/kg/day
(HDT)
Offspring NOAEL = 6.3 mg/kg/day
Offspring LOAEL = 7.6 mg/kg/day based on a
decrease in the number of live born and a
decrease in pup body weight
----------------------------------------------------------------------------------------------------------------
870.4100 Chronic toxicity dogs (12- NOAEL = 100 mg/kg/day
month capsule) LOAEL = 1,000 mg/kg/day (limit dose) based
on increased absolute and relative liver
weights and 300% increase in alkaline
phosphatase values
----------------------------------------------------------------------------------------------------------------
870.4300 Combined chronic toxicity NOAEL males = 1.8 mg/kg/day
carcinogenicity--rats NOAEL females = 2.2 mg/kg/day
LOAEL males = 18.0 mg/kg/day based on
increased chronic nephropathy
LOAEL females = 21.8 mg/kg/day based on
decreased hematological parameters (Hgb,
MCV, MCH and MCHC)
No evidence of carcinogenicity
----------------------------------------------------------------------------------------------------------------
870.4300 Carcinogenicity--mice NOAEL males = 754.1 mg/kg/day
NOAEL females = 859.1 mg/kg/day (limit
dose)
LOAEL = no systemic effects at limit dose
No evidence of carcinogenicity
----------------------------------------------------------------------------------------------------------------
870.5100 Gene mutation in S. Neither cytotoxic nor mutagenic up to 2,000
typhimurium and E. coli [mu]g/plate. There were reproducible
increases in revertant colonies of S.
typhimurium strains TA1538 and TA98 in S9
activated phases of the preliminary
cytotoxicity and both mutation assays.
Results considered to be equivocal
----------------------------------------------------------------------------------------------------------------
870.5375 Gene mutation in chinese Precipitation at =200 [mu]M.
hamster ovary cells Cytotoxicity at 500 [mu]M. Positive +S9
=100 [mu]M and negative at 30-
500 [mu]M -S9. Aberrations were chromatid
breaks and exchanges
----------------------------------------------------------------------------------------------------------------
870.5395 In vivo rat bone marrow Negative in male (up to 5,000 mg/kg) and
female rats (up to 4,400 mg/kg) when
tested orally
----------------------------------------------------------------------------------------------------------------
870.5550 UDS assay Negative up to 5,000 mg/kg
----------------------------------------------------------------------------------------------------------------
870.7485 Metabolism and Gastrointestinal tract absorption >90% at 1
pharmacokinetics mg/kg and up to 50% at 100 mg/kg. At least
97% recovery in feces and urine 7 days
after dosing. Highest levels of residues
(36-49 ppb) in blood cells at low dose and
2,800-3,000 ppm at high dose (RBC levels >
plasma). In addition to untransformed
parent, 7 metabolites identified in urine
and feces (38-46% for low dose and about
71% at high dose)
----------------------------------------------------------------------------------------------------------------
870.7600 Dermal penetration - rat Males dosed with suspension of 50 WDG
formulation in water at 0.02, 0.20 or 1.0
mg/rat (0.002, 0.020 or 0.100 cm2. At 0.02
mg/rat, absorption ranged from 0.48% at
0.5 hours to 5.46% at 24 hours. At 0.2 mg/
rat, absorption ranged from 0.007% at 0.5
hours to 0.74% at 24 hours. At 1.0 mg/rat,
absorption ranged from 0.004% at 0.5 hours
to 10.47% at 24 hours
----------------------------------------------------------------------------------------------------------------
870.7600 Dermal penetration - rat Females dosed with 200 or 800 mg/kg body
weight (bw). Dermalabsorption for 200 and
800 mg/kg was 3.9 and 8.0% by 48 hours
after initiation of treatment for 6 hours.
Blood levels at 6-24 hours after dermal
dosing with 200 mg/kg were similar to
those obtained at 2-6 hours after oral
dosing with 1 mg/kg. Blood levels at 6-24
hours after dermal dosing with 800 mg/kg
were similar to those obtained at 2-6
hours after oral dosing with 30 mg/kg
----------------------------------------------------------------------------------------------------------------
Special studies rat Pregnant females were administered 400 mg/
developmental: Critical kg by gavage on gestation day 11 or 12 or
time for defects 13 or 14 or 15. Day 12 administration
showed: Largest incidence of embryonic
death, lowest fetal body weights and
greatest incidence of ventricular spetal
defect
----------------------------------------------------------------------------------------------------------------
[[Page 16827]]
B. Toxicological Endpoints
The dose at which no adverse effects are observed (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological level of concern
(LOC). However, the lowest dose at which adverse effects of concern are
identified (the LOAEL) is sometimes used for risk assessment if no
NOAEL was achieved in the toxicology study selected. An uncertainty
factor (UF) is applied to reflect uncertainties inherent in the
extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns. An UF of 100 is routinely used, 10x to account for
interspecies differences and 10x for intraspecies differences.
Three other types of safety or uncertainty factors may be used:
``Traditional uncertainty factors''; the ``special FQPA safety
factor''; and the ``default FQPA safety factor.'' By the term
``traditional uncertainty factor,'' EPA is referring to those
additional uncertainty factors used prior to FQPA passage to account
for database deficiencies. These traditional uncertainty factors have
been incorporated by the FQPA into the additional safety factor for the
protection of infants and children. The term ``special FQPA safety
factor'' refers to those safety factors that are deemed necessary for
the protection of infants and children primarily as a result of the
FQPA. The ``default FQPA safety factor'' is the additional 10x safety
factor that is mandated by the statute unless it is decided that there
are reliable data to choose a different additional factor (potentially
a traditional uncertainty factor or a special FQPA safety factor).
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 an UF of
100 to account for interspecies and intraspecies differences and any
traditional uncertainty factors deemed appropriate (RfD = NOAEL/UF).
Where a special FQPA safety factor or the default FQPA safety factor is
used, this additional factor is applied to the RfD by dividing the RfD
by such additional factor. The acute or chronic Population Adjusted
Dose (aPAD or cPAD) is a modification of the RfD to accommodate this
type of safety factor.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the LOC. For example, when 100 is the appropriate UF (10x
to account for interspecies differences and 10x for intraspecies
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and
compared to the LOC.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk). An example of how such a probability risk is expressed
would be to describe the risk as one in one hundred thousand (1 x
10-5), one in a million (1 x 10-6), or one in 10
million (1 x 10-7). Under certain specific circumstances,
MOE calculations will be used for the carcinogenic risk assessment. In
this non-linear approach, a ``point of departure'' is identified below
which carcinogenic effects are not expected. The point of departure is
typically a NOAEL based on an endpoint related to cancer effects though
it may be a different value derived from the dose response curve. To
estimate risk, a ratio of the point of departure to exposure
(MOEcancer = point of departure/exposures) is calculated.
A summary of the toxicological endpoints for flumioxazin used for
human risk assessment is shown in Table 2 of this unit:
Table 2.--Summary of Toxicological Dose and Endpoints for Flumioxazin for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
Dose Used in Risk
Assessment, Special FQPA SF and
Exposure Scenario Interspecies and Level of Concern for Study and Toxicological
Intraspecies and any Risk Assessment Effects
Traditional UF
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Acute dietary (females 13-49 years of NOAEL = 3 mg/kg/day Special FQPA SF = 1 Oral developmental and
age) Acute RfD = 0.03 mg/kg/ aPAD = acute RfD/FQPA supplemental prenatal
day. SF = 0.03 mg/kg/day. studies (rat)
LOAEL = 10 mg/kg/day
based on
cardiovascular effects
(especially
ventricular septal
defects in fetuses)
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Acute dietary (general population An endpoint attributable to a single dose (exposure) was not identified
including infants and children) from the available studies, including the developmental toxicity studies
in rats and rabbits
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Chronic dietary (all populations) NOAEL = 2 mg/kg/day Special FQPA SF = 1 2-Year chronic/
UF = 100............... cPAD = chronic RfD/FQPA carcinogenicity study
Chronic RfD = 0.02 mg/ SF = 0.02 mg/kg/day. (rat)
kg/day. LOAEL = 18 mg/kg/day
based on increased
chronic nephropathy in
males and decreased
hematological
parameters in females
(Hgb, MCV, MCH and
MCHC)
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Cancer (oral, dermal, inhalation) Not likely to be a carcinogen for humans based on the lack of
carcinogenicity in a 2-year rat study, an 18-month mouse study and a
battery of mutagenic studies.
----------------------------------------------------------------------------------------------------------------
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.568) for the residues of flumioxazin, in or on
peanuts and soybean seed. No secondary residues are expected in meat,
milk, poultry or eggs. Risk assessments were conducted by EPA to assess
dietary exposures from flumioxazin in food as follows:
i. Acute exposure. Acute dietary risk assessments are performed for
a food-use pesticide, if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a 1-day or
single exposure.
[[Page 16828]]
In conducting the acute dietary risk assessment EPA used the
Dietary Exposure Evaluation Model software with the Food Commodity
Intake Database (DEEM-FCIDTM), which incorporates food
consumption data 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 the acute analyses, tolerance-level residues were assumed for all
food commodities with current or proposed flumioxazin tolerances, and
it was assumed that all of the crops included in the analysis were
treated. Percent crop treated (PCT) and/or anticipated residues were
not used in the acute risk assessment.
ii. Chronic exposure. In conducting the chronic dietary risk
assessment, EPA used the DEEM-FCIDTM software, which
incorporates food consumption data as reported by respondents in the
USDA 1994-1996 and 1998 Nationwide CSFII, and accumulated exposure to
the chemical for each commodity. The following assumptions were made
for the chronic exposure assessments: For the chronic analyses,
tolerance-level residues were assumed for all food commodities with
current or proposed flumioxazin tolerances, and it was assumed that all
of the crops included in the analysis were treated. PCT and/or
anticipated residues were not used in the chronic risk assessment.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for flumioxazin and its
degradates (482-HA and APF) in drinking water. Because the Agency does
not have comprehensive monitoring data, drinking water concentration
estimates are made by reliance on simulation or modeling taking into
account data on the physical characteristics of flumioxazin and its
degradates (482-HA and APF).
The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) or
the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS), to produce estimates of pesticide concentrations in an index
reservoir. The Screening Concentrations in Ground Water (SCI-GROW)
model is used to predict pesticide concentrations in shallow ground
water. For a screening-level assessment for surface water EPA will use
FIRST (a Tier 1 model) before using PRZM/EXAMS (a Tier 2 model). The
FIRST model is a subset of the PRZM/EXAMS model that uses a specific
high-end runoff scenario for pesticides. Both FIRST and PRZM/EXAMS
incorporate an index reservoir environment, and both models include a
percent crop area factor as an adjustment to account for the maximum
percent crop coverage within a watershed or drainage basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a screen for sorting out pesticides for which it is
unlikely that drinking water concentrations would exceed human health
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), which are the model estimates of a
pesticide's concentration in water. EECs derived from these models are
used to quantify drinking water exposure and risk as a %RfD or %PAD.
Instead drinking water levels of comparison (DWLOCs) are calculated and
used as a point of comparison against the model estimates of a
pesticide's concentration in water. DWLOCs are theoretical upper limits
on a pesticide's concentration in drinking water in light of total
aggregate exposure to a pesticide in food, and from residential uses.
Since DWLOCs address total aggregate exposure to flumioxazin, they are
further discussed in Unit III.E.
Based on the FIRST and SCI-GROW models, the EECs of flumioxazin and
its degradates (482-HA and APF) for acute exposures are estimated to be
a total of 34 parts per billion (ppb) for surface water and 48 ppb for
ground water. The EECs for chronic exposures are estimated to be a
total of 18 ppb for surface water and 48 ppb for ground water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Flumioxazin is not registered for use on any sites that would
result in residential exposure.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to flumioxazin and any other
substances and flumioxazin does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has not assumed that flumioxazin has a
common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see the policy statements released by EPA's Office of
Pesticide Programs (OPP) concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a
common mechanism on EPA's web site at http://www.epa.gov/pesticides/cumulative/
.
D. Safety Factor for Infants and Children
1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. Margins of safety are
incorporated into EPA risk assessments either directly through use of a
MOE analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans. In
applying this provision, EPA either retains the default value of 10X
when reliable data do not support the choice of a different factor, or,
if reliable data are available, EPA uses a different additional safety
factor value based on the use of traditional uncertainty factors and/or
special FQPA safety factors, as appropriate.
2. Prenatal and postnatal sensitivity. Although increased prenatal
and postnatal quantitative susceptibility was seen in rats, it was
concluded that there is low concern and no residual uncertainties for
prenatal and/or postnatal toxicity because:
i. Developmental toxicity NOAELs/LOAELs are well characterized
after oral and dermal exposure.
ii. Offspring toxicity NOAEL/LOAEL are well characterized.
[[Page 16829]]
iii. There is a well-defined dose-response curve for the
cardiovascular effects seen following oral exposure (i.e. critical
period).
iv. The endpoints of concern are used for overall risk assessments
for appropriate route and population subgroups.
3. Conclusion. There is a complete toxicity data base for
flumioxazin and exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures. EPA determined
that the special 10x SF to protect infants and children should be
removed. The FQPA factor is removed because developmental toxicity and
offspring toxicity NOAELs/LOAELs are well characterized; there is a
well-defined dose-response curve for the cardiovascular effects and the
endpoints of concern are used for overall risk assessments are
appropriate for the route of exposure and population subgroups.
E. Aggregate Risks and Determination of Safety
To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against EECs. DWLOC values are
not regulatory standards for drinking water. DWLOCs are theoretical
upper limits on a pesticide's concentration in drinking water in light
of total aggregate exposure to a pesticide in food and residential
uses. In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water (e.g., allowable chronic water exposure (mg/kg/day)) =
cPAD - (average food + residential exposure). This allowable exposure
through drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by EPA's Office of Water are used to calculate DWLOCs: 2
liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg
(child). Default body weights and drinking water consumption values
vary on an individual basis. This variation will be taken into account
in more refined screening-level and quantitative drinking water
exposure assessments. Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
Acute, short-term, intermediate-term, chronic, and cancer.
When EECs for surface water and ground water are less than the
calculated DWLOCs, EPA concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which EPA has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because EPA considers the aggregate risk resulting from
multiple exposure pathways associated with a pesticide's uses, levels
of comparison in drinking water may vary as those uses change. If new
uses are added in the future, EPA will reassess the potential impacts
of residues of the pesticide in drinking water as a part of the
aggregate risk assessment process.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food to
flumioxazin will occupy < 1% of the aPAD for females 13 to 49 years
old. In addition, there is potential for acute dietary exposure to
flumioxazin in drinking water. After calculating DWLOCs and comparing
them to the EECs for surface water and ground water, EPA does not
expect the aggregate exposure to exceed 100% of the aPAD, as shown in
Table 3 of this unit:
Table 3.-- Aggregate Risk Assessment for Acute Exposure to Flumioxazin
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup aPAD (mg/ % aPAD Water EEC Water EEC Acute DWLOC
kg) (Food) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
Females 13-49 years 0.03 <1 34 48 900
----------------------------------------------------------------------------------------------------------------
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
flumioxazin from food will utilize <1% of the cPAD for the U.S.
population, <1% of the cPAD for all infant and children subpopulations.
There are no residential uses for flumioxazin that result in chronic
residential exposure to flumioxazin. In addition, there is potential
for chronic dietary exposure to flumioxazin in drinking water. After
calculating DWLOCs and comparing them to the EECs for surface water and
ground water, EPA does not expect the aggregate exposure to exceed 100%
of the cPAD, as shown in Table 4 of this unit:
Table 4.--Aggregate Risk Assessment for Chronic (Non- Cancer) Exposure to flumioxazin
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD (mg/kg/ % cPAD Water EEC Water EEC Chronic
day) (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 0.02 <1 18 48 700
---------------------------------------------------------------------------
All infants (<1 year) 0.02 <1 18 48 200
---------------------------------------------------------------------------
Females 13-49 years 0.02 <1 18 48 600
----------------------------------------------------------------------------------------------------------------
3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
Flumioxazin is not registered for use on any sites that would
result in residential exposure. Therefore, the aggregate risk is the
sum of the risk from food and water, which do not exceed the Agency's
level of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure
[[Page 16830]]
plus chronic exposure to food and water (considered to be a background
exposure level).
Flumioxazin is not registered for use on any sites that would
result in residential exposure. Therefore, the aggregate risk is the
sum of the risk from food and water, which do not exceed the Agency's
level of concern.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to flumioxazin residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (example--gas chromatography) is
available to enforce the tolerance expression. The method may be
requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone
number: (410) 305-2905; e-mail address: residuemethods@epa.gov.
B. International Residue Limits
There are no Codex, Canadian or Mexican maximum residue limits
established on cotton.
V. Conclusion
Therefore, the tolerance is established for residues of
flumioxazin, (2-[7-fluoro-3,4-dihydro-3-oxo-4-(2-propynyl)-2H-1,4-
benzoxazin-6-yl]-4,5,6,7-tetrahydro-1H-isoindole-1,3(2H)-dione) in or
on cottonseed at 0.02 ppm and cotton gin byproducts at 0.60 ppm
VI. Objections and Hearing Requests
Under section 408(g) of FFDCA, as amended by FQPA, any person may
file an objection to any aspect of this regulation and may also request
a hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. Although the procedures in those regulations require
some modification to reflect the amendments made to FFDCA by FQPA, EPA
will continue to use those procedures, with appropriate adjustments,
until the necessary modifications can be made. The new section 408(g)
of FFDCA provides essentially the same process for persons to
``object'' to a regulation for an exemption from the requirement of a
tolerance issued by EPA under new section 408(d) of FFDCA, as was
provided in the old sections 408 and 409 of FFDCA. However, the period
for filing objections is now 60 days, rather than 30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number OPP-2004-0089 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 June 1,
2004.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (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 VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.1. Mail your
copies, identified by docket ID number OPP-2004-0089, 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).
[[Page 16831]]
VII. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does
not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under section 408(d) of FFDCA, such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has
determined that this rule does not have any ``tribal implications'' as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
Order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.
VIII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: March 22, 2004.
Betty Shackleford,
Acting Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.568 is amended by alphabetically adding the following
commodities to the table in paragraph (a) to read as follows:
Sec. 180.568 Flumioxazin; tolerances for residues.
(a) * * *
----------------------------------------------------------------------------------------------------------------
Commodity Parts per million
----------------------------------------------------------------------------------------------------------------
Cotton, gin byproducts................................ 0.60
Cottonseed............................................ 0.02
* * * * *
----------------------------------------------------------------------------------------------------------------
[[Page 16832]]
* * * * *
[FR Doc. 04-7198 Filed 3-30-04; 8:45 am]
BILLING CODE 6560-50-S