[Federal Register Volume 66, Number 75 (Wednesday, April 18, 2001)]
[Rules and Regulations]
[Pages 19870-19879]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-9597]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301116; FRL-6778-5]
RIN 2070-AB78


Flumioxazin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerances for residues of 
flumioxazin in or on soybean seed and peanuts. Valent U.S.A. 
Corporation requested this tolerance under the Federal Food, Drug, and 
Cosmetic Act, as amended by the Food Quality Protection Act of 1996.

DATES: This regulation is effective April 18, 2001. Objections and 
requests for hearings, identified by docket control number OPP-301116, 
must be received by EPA on or before June 18, 2001.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please

[[Page 19871]]

follow the detailed instructions for each method as provided in Unit 
VI.. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, 
your objections and hearing requests must identify docket control 
number OPP-301116 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: By mail: Joanne I. Miller, 
Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., 
NW.,Washington, DC 20460; telephone number: (703) 305-6224; and e-mail 
address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                      affected  entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    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 the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
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 Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically.You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/. To access the OPPTS Harmonized 
Guidelines referenced in this document, go directly to the guidelines 
at http://www.epa.gov/opptsfrs/home/guidelin.htm. A frequently updated 
electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180._00.html, a 
beta site currently under development.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301116. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of February 14, 2001 (66 FR 10292) (FRL-
6765-8), EPA issued a notice pursuant to section 408 of the Federal 
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the 
Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170) 
announcing the filing of pesticide petitions (PP 7F4841 and OF6171) for 
tolerances by Valent U.S.A. Corporation, 1333 North California, 
Boulevard, Suite 600, Walnut Creek, CA 94596-8025. This 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 part 180 be amended by 
establishing tolerances for residues of the herbicide flumioxazin, 2-
[7-fluoro-3,4-dihydro-3-oxo-4-(2-propynyl)-2H-1,4-benzoxazin-6-yl]-
4,5,6,7-tetrahydro-1H-isoindole-1,3(2H)-dione, in or on soybean seed 
and peanuts at 0.01 part per million (ppm). Valent U.S.A. Corporation 
subsequently amended the petition to request tolerances in or on 
soybean seed and peanut nutmeat at 0.02 ppm.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) 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) 
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 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), 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), for a tolerances for residues of flumioxazin on soybean seed 
and peanut nutmeat at 0.02 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 the following Table 1 as well as the no observed adverse 
effect level (NOAEL) and the lowest observed

[[Page 19872]]

adverse effect level (LOAEL) from the toxicity studies reviewed.

                               Table 1.-- Subchronic, Chronic, and Other Toxicity
----------------------------------------------------------------------------------------------------------------
             Guideline No.                       Study type                            Results
----------------------------------------------------------------------------------------------------------------
870.1000                                 Acute Oral - rat            LD50>5,000 mg/kg (M and F); 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/L
----------------------------------------------------------------------------------------------------------------
870.2400                                 Primary Eye Irritation -    No corneal irritation; mild irritation of
                                          rabbit                      iris cleared by 24 hours; mild irritation
                                                                      of conjunctival 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 - rat  NOAEL = mg/kg/day: 69.7 (M), 71.5 (F)
 
                                                                     LOAEL = mg/kg/day: 243.5 (M), 229.6 (F)
                                                                      based on a decrease in MCV both sexes;
                                                                      increase in platelets F only
----------------------------------------------------------------------------------------------------------------
870.3100                                 90-Day oral toxicity - rat  NOAEL = mg/kg/day: 65.0 (M), 72.9 (F)
 
                                                                     LOAEL = mg/kg/day: 196.7 (M), 218.4 (F)
                                                                      based on hematology changes
----------------------------------------------------------------------------------------------------------------
870.3150                                 90-Day capsule - dog        NOAEL = mg/kg/day: 10 (M and F) LOAEL = mg/
                                                                      kg/day: 100 (M and F) based on dose
                                                                      dependent increase in total cholesterol,
                                                                      phospholipid and alkaline phosphatase
----------------------------------------------------------------------------------------------------------------
870.3100                                 90-Day oral toxicity -      NOAEL = mg/kg/day: 429 (M and F) LOAEL = mg/
                                          mouse                       kg/day: 1429 (M and F) based on increased
                                                                      liver weight in males
----------------------------------------------------------------------------------------------------------------
870.3100                                 4-Week oral toxicity -      NOAEL = mg/kg/day: 151.5 (M), 164.5 (F)
                                          mouse                       LOAEL = mg/kg/day: 419.9 (M), 481.6 (F)
                                                                      based on increased absolute and/or
                                                                      relative liver weights in M and F
----------------------------------------------------------------------------------------------------------------
870.3200                                 21-Day dermal toxicity -    NOAEL = mg/kg/day: 1,000 (LIMIT DOSE) LOAEL
                                          rat                         = mg/kg/day: 1,000 based on no
                                                                      effects
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870.3700a                                Prenatal developmental -    Maternal NOAEL = 30 mg/kg/day (HDT) LOAEL =
                                          rat (oral)                  >30 mg/kg/day (HDT) Developmental NOAEL =
                                                                      3 mg/kg/day LOAEL = 10 mg/kg/day based on
                                                                      cardiovascular effects (especially
                                                                      ventricular septal defects)
----------------------------------------------------------------------------------------------------------------
870.3700a                                Prenatal developmental -    Maternal NOAEL = 300 mg/kg/day (HDT) LOAEL
                                          rat (dermal)                = >300 mg/kg/day (HDT) Developmental NOAEL
                                                                      = 30 mg/kg/day LOAEL = 100 mg/kg/day based
                                                                      on cardiovascular effects (especially
                                                                      ventricular septal defects)
----------------------------------------------------------------------------------------------------------------
870.3700b                                Prenatal developmental -    Maternal NOAEL = 1,000 mg/kg/day LOAEL =
                                          rabbit (oral)               3,000 mg/kg/day (HDT) based on decrease in
                                                                      body weight and food consumption during
                                                                      dosing Developmental NOAEL = 3000 mg/kg/
                                                                      day (HDT) LOAEL = >3,000 mg/kg/day
----------------------------------------------------------------------------------------------------------------
870.3800                                 Reproduction and fertility  Parental/Systemic NOAEL = mg/kg/day: males
                                          effects - rat               = 12.7, females = 15.1 LOAEL = mg/kg/day:
                                                                      males = 18.9, females = 22.7 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 = mg/kg/day: males =
                                                                      18.9 (HDT), females = 22.7 (HDT) LOAEL =
                                                                      mg/kg/day: males = >18.9 (HDT), females =
                                                                      >22.7 (HDT) Offspring NOAEL = mg/kg/day:
                                                                      males = 6.3, females = 7.6 LOAEL = mg/kg/
                                                                      day: males = 12.7, females = 15.1 based on
                                                                      a decrease in the number of liveborn and a
                                                                      decrease in pup body weight
----------------------------------------------------------------------------------------------------------------
870.4100                                 12-Month capsule - dog      NOAEL = 100 mg/kg/day (M and F) LOAEL =
                                                                      1,000 mg/kg/day (M and F), (LIMIT DOSE)
                                                                      based on the following for males and
                                                                      females: increased absolute and relative
                                                                      liver weights; 300% increase in alkaline
                                                                      phosphatase values
----------------------------------------------------------------------------------------------------------------
870.4200                                 Carcinogenicity - mouse     NOAEL = mg/kg/day: males = 754.1, females =
                                                                      859.1 (LIMIT DOSE) LOAEL = no systemic
                                                                      effects at LIMIT DOSE in males or females
 
                                                                     No evidence of carcinogenicity
----------------------------------------------------------------------------------------------------------------

[[Page 19873]]

 
870.4300                                 Combined chronic            NOAEL = mg/kg/day: males = 1.8, females =
                                          carcinogenicity - rat       2.2 LOAEL = mg/kg/day: males = 18.0,
                                                                      females = 21.8 based on increased chronic
                                                                      nephropathy in males and decreased
                                                                      hematological parameters in females (Hgb,
                                                                      MCV, MCH and MCHC)
 
                                                                     No evidence of carcinogenicity
----------------------------------------------------------------------------------------------------------------
870.5100                                 Gene mutation in S.         Neither cytotoxic nor mutagenic up to 2,000
                                          typhimurium and E. coli     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 M.
                                          hamster ovary cells         Cytotoxicity at 500 M. Positive
                                                                      +S9 100 M and negative
                                                                      at 30-500 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 - rat      mg/kg and up to 50% at 100 mg/kg. At least
                                          (oral)                      97% recovery in feces and urine 7 days
                                                                      after dosing. Highest levels of residues
                                                                      (36-49 ppb) in blood cells at low dose and
                                                                      2800-3000 ppg 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 b.w.
                                                                      Dermal absorption 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 Study - 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
                                                                      defects.
----------------------------------------------------------------------------------------------------------------

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 intra species differences.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by the 
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is 
retained due to concerns unique to the FQPA, this additional factor is 
applied to the RfD by dividing the RfD by such additional factor. The 
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a 
modification of the RfD to accommodate this type of FQPA 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 is expressed as 1 x 10-6 or one in a million). 
Under certain specific circumstances, MOE calculations will be used for 
the carcinogenic risk assessment. In this non-linear approach, a 
``point of departure'' is identified below which carcinogenic effects 
are not expected. The point of departure is typically a NOAEL based on 
an endpoint related to cancer effects though it may be a different 
value derived from the dose response curve. To estimate risk, a ratio 
of the point of departure to exposure (MOE cancer = point of 
departure/exposures) is calculated. A summary of the toxicological 
endpoints for flumioxazin used for human risk assessment is shown in 
the following Table 2:

[[Page 19874]]



     Table 2.--Summary of Toxicological Dose and Endpoints for Flumioxazin for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                 FQPA SF* and level of
          Exposure scenario               Dose used in risk         concern for risk     Study and toxicological
                                            assessment, UF             assessment                effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary Females 13-50            NOAEL = 3 mg/kg/day      FQPA SF = 10 aPAD =      Oral developmental and
                                        Acute RfD = 0.03 mg/kg/  acute RfD FQPA SF =      supplemental prenatal
                                        day                      0.003 mg/kg/day          studies in the 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
                                        from the available studies, including the developmental toxicity studies
                                                                  in rats and rabbits.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary all populations        NOAEL = 2 mg/kg/day UF   FQPA SF = 10 cPAD =      2-Year Chronic/
                                        = 100 Chronic RfD =      chronic RfD FQPA SF =    Carcinogenicity Study
                                        0.02 mg/kg/day           0.002 mg/kg/day          in the rat LOAEL = 18
                                                                                          mg/kg/day based on
                                                                                          increased chronic
                                                                                          nephropathy in males
                                                                                          and decreased
                                                                                          hematological
                                                                                          parameters in females
                                                                                          (Hgb, MCV, MCH and
                                                                                          MCHC)
----------------------------------------------------------------------------------------------------------------
Incidental Oral (short and              NOAEL = 65 mg/kg/day    Target MOE = 1,000       90-Day Toxicity Studies
 intermediate term)                                              (Residential)            in the rat LOAEL =
                                                                                          196.7 mg/kg/day based
                                                                                          on hematology changes
                                                                                          (decrease in MCV and
                                                                                          increase in female
                                                                                          platelets)
----------------------------------------------------------------------------------------------------------------
Dermal (all durations)                 NOAEL = 30 mg/kg/day     Target MOE = 1,000       Dermal Developmental
                                                                 (Residential)            Study in the rat LOAEL
                                                                                          = 100 mg/kg/day based
                                                                                          on cardiovascular
                                                                                          effects (especially
                                                                                          ventricular septal
                                                                                          defects in fetuses)
----------------------------------------------------------------------------------------------------------------
Short-term Inhalation                  NOAEL = 3 mg/kg/day      Target MOE = 1,000       Oral Developmental
                                                                 (Residential)            Study in the rat LOAEL
                                                                                          = 10 mg/kg/day based
                                                                                          on cardiovascular
                                                                                          effects (especially
                                                                                          ventricular septal
                                                                                          defects in fetuses)
----------------------------------------------------------------------------------------------------------------
Intermediate- and Long-term            NOAEL = 2 mg/kg/day      Target MOE = 1,000       2-Year Chronic/
 Inhalation                                                      (Residential)            Carcinogenicity Study
                                                                                          in the rat LOAEL = 18
                                                                                          mg/kg/day based on
                                                                                          increased chronic
                                                                                          nephropathy in males
                                                                                          and decreased
                                                                                          hematological
                                                                                          parameters in females
                                                                                          (Hgb, MCV, MCH and
                                                                                          MCHC)
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)            Not likely to be a carcinogen for humans based on the lack of
                                          carcinogenicity in a 2-year rat study, an 18-month mouse study and a
                                                              battery of mutagenic studies.
----------------------------------------------------------------------------------------------------------------
*The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique
  to the FQPA.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. No previous tolerances 
have been established for the residues of flumioxazin. Risk assessments 
were conducted by EPA to assess dietary exposures from flumioxazin in 
food as follows:
    i. Acute exposure. Acute dietary risk assessments are performed for 
a food-use pesticide if a toxicological study has indicated the 
possibility of an effect of concern occurring as a result of a one day 
or single exposure. The Dietary Exposure Evaluation Model (DEEM) 
analysis evaluated the individual food consumption as reported by 
respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food 
Intake by Individuals (CSFII) and accumulated exposure to the chemical 
for each commodity. The following assumptions were made for the acute 
exposure assessments: For this acute analysis the assumption was made 
that 100% of the crops with flumioxazin tolerances are treated with 
flumioxazin. In addition, the assumption was made that all commodities 
contain tolerance level residues when consumed, with the exception of 
those with default processing factors. Default processing factors were 
used for peanuts-butter (1.89x) and for soybeans-sprouted seeds 
(0.33x). As the exposure and risk estimates were low, no further 
refinements were made to this analysis.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the DEEM analysis evaluated the individual food consumption 
as reported by respondents in the USDA 1989-1992 nationwide CSFII and 
accumulated exposure to the chemical for each commodity. The following 
assumptions were made for the chronic exposure assessments: For this 
chronic analysis the assumption was made that 100% of the crops with 
flumioxazin tolerances are treated with flumioxazin. In addition, the 
assumption was made that all commodities contain tolerance level 
residues when consumed, with the exception of those with default 
processing factors. Default processing factors were used for peanuts-
butter (1.89x) and for soybeans-sprouted seeds (0.33x). As the exposure 
and risk estimates were low, no further refinements were made to this 
analysis.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for flumioxazin in drinking 
water. Because the Agency does not have comprehensive monitoring data, 
drinking water concentration estimates are made by reliance on 
simulation or modeling taking into account data on the physical 
characteristics of flumioxazin.
    The Agency uses the Generic Estimated Environmental Concentration 
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System 
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and 
Screening Concentrations in Ground

[[Page 19875]]

Water (SCI-GROW), which predicts pesticide concentrations in 
groundwater. In general, EPA will use GENEEC (a tier 1 model) before 
using PRZM/EXAMS (a tier 2 model) for a screening-level assessment for 
surface water. The GENEEC model is a subset of the PRZM/EXAMS model 
that uses a specific high-end runoff scenario for pesticides. GENEEC 
incorporates a farm pond scenario, while PRZM/EXAMS incorporate an 
index reservoir environment in place of the previous pond scenario. The 
PRZM/EXAMS model includes a percent crop area factor as an adjustment 
to account for the maximum percent crop coverage within a watershed or 
drainage basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a coarse screen for sorting out pesticides for 
which it is highly unlikely that drinking water concentrations would 
ever exceed human health levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs) from these models to quantify 
drinking water exposure and risk as a %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 the aggregate risk sections below.
    The hydrolysis study for flumioxazin indicates that flumioxazin 
forms the metabolite 482-HA, which can further hydrolyze to metabolites 
APF and THPA. The rates of the two hydrolytic reactions are very pH 
dependent, but the parent is not very stable at any likely 
environmental pH. Additional data indicated that THPA and APF are 
likely to be very mobile. Although THPA can comprise a major portion of 
the total residue in water, it does not possess the phenyl ring and is 
thus considered significantly less toxic than parent, APF, and 482-HA, 
thus THPA needs not be included in the residue of concern for drinking 
water. Therefore, parent flumioxazin and the metabolites 482-HA and APF 
are the residues of concern in drinking water.
    Based on the GENEEC and SCI-GROW models the estimated environmental 
concentrations (EECs) of flumioxazin and its metabolites of concern in 
water for acute exposures are estimated to be 2.4 parts per billion 
(ppb) for surface water and 6.3 ppb for ground water. The EECs for 
chronic exposures are estimated to be 0.67 ppb for surface water and 
6.3 ppb for ground water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Flumioxazin is not registered for use on any sites that would 
result in residential exposure.
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) requires that, when considering 
whether to establish, modify, or revoke a tolerance, the Agency 
consider ``available information'' concerning the cumulative effects of 
a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether flumioxazin has a common mechanism of toxicity with other 
substances or how to include this pesticide in a cumulative risk 
assessment. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, 
flumioxazin does not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this tolerance action, therefore, 
EPA has not assumed that flumioxazin has a common mechanism of toxicity 
with other substances. For information regarding EPA's efforts to 
determine which chemicals have a common mechanism of toxicity and to 
evaluate the cumulative effects of such chemicals, see the final rule 
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

D. Safety Factor for Infants and Children

    1. In general. FFDCA section 408 provides that EPA shall apply an 
additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
unless EPA determines that a different margin of safety will be safe 
for infants and children. Margins of safety are incorporated into EPA 
risk assessments either directly through use of a margin of exposure 
(MOE) analysis or through using uncertainty (safety) factors in 
calculating a dose level that poses no appreciable risk to humans.
    2. Prenatal and postnatal sensitivity. The data for flumioxazin 
indicate that there is both quantitative and qualitative evidence of 
increased susceptibility to flumioxazin from prenatal or postnatal 
exposures. Quantitative susceptibility is observed when the young 
respond more than the adults at a given dose, and qualitative 
susceptibility is observed when there is a unique biological target, 
such as the developing brain, that predisposes the individual.
    The quantitative and qualitative evidence of increased 
susceptibility is observed with the rat fetuses to in utero exposure to 
flumioxazin in the oral and dermal developmental studies. In both 
studies, there was an increased incidence in fetal cardiovascular 
anomalies (especially ventricular septal defects). In the oral study, 
no maternal effects were seen at the highest dose tested (HDT) (30 
milligrams/kilograms (mg/kg/day)); whereas, the effects in the fetuses 
were observed at 10 mg/kg/day. In the dermal study, no maternal effects 
were noted at the HDT (300 mg/kg/day); whereas, the effects in the 
fetuses were observed at 100 mg/kg/day. Regarding the 2-generation rat 
reproduction study, parental effects (red substance in vagina and 
increased mortality in females as well as decreases in male and female 
body weights, body weight gains, and food consumption) were noted at 
18.9 mg/kg/day in males HDT and 22.7 mg/kg/day in females HDT. Based on 
the results of the study, no apparent reproduction effects were 
attributed to test article administration. The effects observed 
regarding the offspring were a decrease in both the number of liveborn 
and pup body weights at 12.7 mg/kg/day for males and 15.1 mg/kg/day for 
females. Therefore, it was considered that there was both a 
quantitative and qualitative increase in susceptibility.
    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. The FQPA safety 
factor (as required by the Food Quality Protection Act of August 3, 
1996) has been retained at 10x for all population subgroups for all 
exposure durations (acute and chronic) in assessing the risk posed by 
this chemical. The reasons for retaining the 10x safety factor are as 
follows. First, there is evidence of increased susceptibility of the 
rat fetuses to in utero exposure to flumioxazin by the

[[Page 19876]]

oral and dermal route in the prenatal developmental toxicity studies in 
rats. In addition, there is evidence of increased susceptibility of 
young animals exposed to flumioxazin in the 2-generation reproduction 
toxicity study in rats. Finally, there is concern for the severity of 
the effects observed in fetuses and young animals when compared to 
those observed in the maternal and parental animals (dose- and 
treatment-related increase in the incidence of cardiovascular 
abnormalities, particularly ventricular septal defect, in the 
developmental studies; and decreases in the number of live born pups 
and pup body weights in the absence of parental toxicity in the 
reproduction study).

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 the model estimates of 
a pesticide's concentration in water (EECs). DWLOC values are not 
regulatory standards for drinking water. DWLOCs are theoretical upper 
limits on a pesticide's concentration in drinking water in light of 
total aggregate exposure to a pesticide in food and residential uses. 
In calculating a DWLOC, the Agency determines how much of the 
acceptable exposure (i.e., the PAD) is available for exposure through 
drinking water e.g., allowable chronic water exposure (mg/kg/day) = 
cPAD - (average food + residential exposure). This allowable exposure 
through drinking water is used to calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the USEPA Office of Water are used to calculate 
DWLOCs: 2L/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 groundwater are less than the 
calculated DWLOCs, OPP concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which OPP has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because OPP 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, OPP 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 to the subgroup of concern, the acute dietary 
exposure from food to flumioxazin will occupy 0.72% of the aPAD for 
females 13 years and older. 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 and ground water, EPA 
does not expect the aggregate exposure to exceed 100% of the aPAD, as 
shown in the following Table 3:

                      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+ years)                                    0.003         0.72          2.4          6.3           90
----------------------------------------------------------------------------------------------------------------

    2. Chronic risk. Using the exposure assumptions described inthis 
unit for chronic exposure, EPA has concluded that exposure to 
flumioxazin from food will utilize 0.5% of the cPAD for the U.S. 
population, 2.3% of the cPAD for all infants (< 1 year) and 1.2% of the 
cPAD for children (1-6 years). 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 and ground water, EPA does not expect the 
aggregate exposure to exceed 100% of the cPAD, as shown in the 
following Table 4:

              Table 4.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to flumioxazin
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
            U.S population subgroup              cPAD mg/kg/     % cPAD     water EEC    water EEC     Chronic
                                                     day         (food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population                                        0.002          0.5         0.67          6.3           70
----------------------------------------------------------------------------------------------------------------
Infants (< 1 year)                                     0.002          2.3         0.67          6.3           20
----------------------------------------------------------------------------------------------------------------
Females (13+ years)                                    0.002          0.4         0.67          6.3           60
----------------------------------------------------------------------------------------------------------------
Males (13 - 19 years)                                  0.002          0.6         0.67          6.3           70
----------------------------------------------------------------------------------------------------------------

    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 19877]]

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.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to flumioxazin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography) is available 
to enforce the tolerance expression. The method may be requested from: 
Calvin Furlow, PIRIB, IRSD (7502C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW, 
Washington, DC 20460; telephone number: (703) 305-5229; e-mail address: 
[email protected].

B. International Residue Limits

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

V. Conclusion

    Therefore, the tolerances are 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 soybean seed and peanuts at 0.02 ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) 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), as was provided in the old FFDCA sections 408 and 409. 
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 control number OPP-301116 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 18, 
2001.
    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 (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
    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.
    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.
    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.2. Mail your 
copies, identified by docket control number OPP-301116, 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. 
In person or by courier, bring a copy to the location of the PIRIB 
described in Unit I.B.2. 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).

VII. Regulatory Assessment Requirements

    This final rule establishes a tolerance under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and

[[Page 19878]]

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). 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 FFDCA section 408(d), such as the exemption 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 FFDCA section 408(n)(4). 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. Submission to Congress and the Comptroller General

    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: April 7, 2001.
Joseph J. Merenda,
Acting Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180-- [AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:

    Authority: 21 U.S.C. 321(q), 346(a) and 371.

    2. Section 180.568 is added to read as follows:


Sec. 180.568  Flumioxazin; tolerances for residues.

    (a) General. Tolerances are 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 the following raw agricultural commodities:

------------------------------------------------------------------------
                                                                  Parts
                           Commodity                               per
                                                                 million
------------------------------------------------------------------------
Peanuts                                                          0.02
Soybean seed                                                     0.02
------------------------------------------------------------------------


[[Page 19879]]

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 01-9597 Filed 4-17-01; 8:45 am]
BILLING CODE 6560-50-S