[Federal Register Volume 69, Number 62 (Wednesday, March 31, 2004)]
[Rules and Regulations]
[Pages 16823-16832]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-7198]


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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: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS 111), e.g., agricultural 
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle 
ranchers and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., 
agricultural workers; farmers; greenhouse, nursery, and floriculture 
workers; ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 32532), e.g., 
agricultural workers; commercial applicators; farmers; greenhouse, 
nursery, and floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I 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
----------------------------------------------------------------------------------------------------------------
             Guideline No.                       Study Type                            Results
----------------------------------------------------------------------------------------------------------------
870.1000                                 Acute oral toxicity (rat)   LD50 > 5,000 milligrams/kilogram (mg/kg);
                                                                      no clinical signs
----------------------------------------------------------------------------------------------------------------
870.1100                                 Acute dermal (rat)          LD50 >2,000 mg/kg; no clinical signs
----------------------------------------------------------------------------------------------------------------
870.1200                                 Acute inhalation (rat)      LC50 = 3.93 mg/Liter (L)
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
870.2500                                 Primary skin irritation -   No erythema or edema
                                          rabbit
----------------------------------------------------------------------------------------------------------------
870.2600                                 Dermal sensitization -      Not a dermal sensitizer
                                          guinea pig
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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)
----------------------------------------------------------------------------------------------------------------
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)
----------------------------------------------------------------------------------------------------------------

[[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
----------------------------------------------------------------------------------------------------------------
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)
-----------------------------------------------------------------------------------------
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
-----------------------------------------------------------------------------------------
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)
-----------------------------------------------------------------------------------------
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: [email protected].

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 [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 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:  [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).

[[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