[Federal Register Volume 66, Number 34 (Tuesday, February 20, 2001)]
[Rules and Regulations]
[Pages 10817-10826]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-2047]


=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301094; FRL-6761-1]
RIN 2070-AB78


Flutolanil, N-(3-(1-methylethoxy)phenyl)-2-
(trifuoromethyl)benzamide; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

[[Page 10818]]


ACTION:  Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of the 
fungicide flutolanil, N-(3-(1-methylethoxy)phenyl)-2-
(trifluoromethyl)benzamide and metabolites converted to 2-
(trifluoromethyl) benzoic acid, calculated as flutolanil in or on rice 
grain, rice straw, rice hulls, rice bran, potatoes, and potato, wet 
peel. Aventis 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 February 20, 2001. Objections and 
requests for hearings, identified by docket control number OPP-301094, 
must be received by EPA on or before April 23, 2001.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please 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-301094 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT By mail: Mary Waller, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460; 
telephone number: (703) 308-9354; 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.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301094. 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 January 24, 2000 (65 FR 3690) (FRL-6486-
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 6F4693 and 4F4380) for tolerances 
by Aventis Crop Science, 2 TW Alexander Drive, Research Triangle Park, 
NC 27709. This notice included a summary of the petition prepared by 
the registrant Aventis, then known as AgrEvo USA Company and located at 
2711 Centerville Rd, Wilmington, DE, 19808. There were no comments 
received in response to the notice of filing.
    The petition requested that 40 CFR 180.484 be amended by 
establishing tolerances for residues of the fungicide flutolanil,  N-
(3-(1-methylethoxy)phenyl)-2-(trifluoromethyl)benzamide and its 
metabolites converted to 2-(trifluoromethyl) benzoic acid, calculated 
as flutolanil, in or on the raw agricultural commodities potatoes at 
0.20 part per million (ppm), potato waste (wet) at 0.4 ppm, rice, grain 
at 2.0 ppm, rice, straw at 12.0 ppm, and in or on the processed food 
commodities rice, hulls at 7.0 ppm, and rice, bran at 3.0 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

[[Page 10819]]

hazards of and to make a determination on aggregate exposure, 
consistent with section 408(b)(2), for a tolerance for residues of 
flutolanil, N-(3-(1-methylethoxy)phenyl)-2-(trifluoromethyl) benzamide 
and its metabolites converted to 2-(trifluoromethyl) benzoic acid, 
calculated as flutolanil in or on the raw agricultural commodities 
potatoes at 0.20 ppm, rice, grain at 7.0 ppm, rice, straw at 10.0 ppm, 
and in or on the processed food commodities potato, wet peel at 0.3 
ppm, rice, hulls at 25.0 ppm, and rice bran at 10.0 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 flutolanil are 
discussed in the following Table 1 as well as the no observed adverse 
effect level (NOAEL) and the lowest observed adverse effect level 
(LOAEL) from the toxicity studies reviewed.

            Table 1.--Subchronic, Chronic, and Other Toxicity
------------------------------------------------------------------------
         Guideline No.               Study Type            Results
------------------------------------------------------------------------
870.1100                         Acute Oral          LD50 > 10 g/kg,
                                                      acute toxicity
                                                      category IV
------------------------------------------------------------------------
870.1200                         Acute Dermal        LD50 > 2 g/kg,
                                                      acute toxicity
                                                      category III
------------------------------------------------------------------------
870.1300                         Acute Inhalation    LC50 > 5.98 mg/L (4
                                                      hours), acute
                                                      toxicity category
                                                      IV
------------------------------------------------------------------------
870.2400                         Primary Eye         Minimal irritation,
                                  Irritation          acute toxicity
                                                      category IV
------------------------------------------------------------------------
870.2500                         Primary dermal      Not a dermal
                                  Irritation          irritant, acute
                                                      toxicity category
                                                      IV
------------------------------------------------------------------------
870.2600                         Dermal              Not a dermal
                                  Sensitization       sensitizer
------------------------------------------------------------------------
870.3100                         90-Day oral         NOAEL = 37 mg/kg/
                                  toxicity rats -     day LOAEL = 299 mg/
                                  diet                kg/day based on
                                                      increased absolute
                                                      and relative liver
                                                      weights (males and
                                                      females) and
                                                      slight decrease in
                                                      body weights
                                                      (males).
------------------------------------------------------------------------
870.3150                         90-Day oral         NOAEL = 80 mg/kg/
                                  toxicity in         day, LOAEL = 400
                                  nonrodents (dog)    mg/kg/day based on
                                                      enlarged livers
                                                      and increased
                                                      severity of
                                                      glycogen
                                                      deposition in both
                                                      males and females.
------------------------------------------------------------------------
870.3200                         21-Day dermal       NOAEL = 1,000 mg/kg/
                                  toxicity - rat      day (limit dose)
                                                      LOAEL > 1,000 mg/
                                                      kg/day
------------------------------------------------------------------------
870.3250                         90-Day dermal       Not available
                                  toxicity
------------------------------------------------------------------------
870.3465                         90-Day inhalation   Not available
                                  toxicity
------------------------------------------------------------------------
870.3700a                        Prenatal            Maternal NOAEL  1,000 mg/
                                  rat, oral gavage    kg/day, LOAEL >
                                                      1,000 mg/kg/day,
                                                      Developmental
                                                      NOAEL 
                                                      1,000 mg/kg/day,
                                                      LOAEL > 1,000 mg/
                                                      kg/day.
------------------------------------------------------------------------
870.3700b                        Prenatal            Maternal NOAEL  1,000 mg/
                                  rabbit, oral        kg/day, LOAEL >
                                  gavage              1,000 mg/kg/day,
                                                      Developmental
                                                      NOAEL 
                                                      1,000 mg/kg/day,
                                                      LOAEL > 1,000 mg/
                                                      kg/day.
------------------------------------------------------------------------
870.3800                         Reproduction and    Parental/Systemic
                                  fertility effects   NOAEL 
                                  in rat - 2          1,000 mg/kg/day,
                                  generation - diet   LOAEL > 1,000 mg/
                                                      kg/day,
                                                      Reproductive NOAEL
                                                       1,000
                                                      mg/kg/day, LOAEL >
                                                      1,000 mg/kg/day.
------------------------------------------------------------------------
870.3800                         Reproduction And    Parental/Systemic
                                  Fertility Effects   NOAEL 
                                  In Rat - 3          661 mg/kg/day,
                                  Generation - diet   LOAEL > 661 mg/kg/
                                                      day, Reproductive
                                                      NOAEL 
                                                      661 mg/kg/day,
                                                      LOAEL > 661 mg/kg/
                                                      day.
------------------------------------------------------------------------
870.4100a                        Chronic toxicity    See combined
                                  rodents             chronic/
                                                      carcinogenicity
                                                      study below.
------------------------------------------------------------------------
870.4100b                        Chronic toxicity -  NOAEL = 50 mg/kg/
                                  dogs - gelatin      day, LOAEL = 1250
                                  capsule             mg/kg/day based on
                                                      increase of
                                                      clinical toxic
                                                      signs (emesis,
                                                      salivation, and
                                                      soft stool), lower
                                                      body weight gains
                                                      and decreased food
                                                      consumption.
------------------------------------------------------------------------
870.4100a and 870.4200           Chronic/            Systemic NOAEL = 87
                                  Oncogenicity Rats   mg/kg/day,
                                  - diet              Systemic LOAEL =
                                                      460 mg/kg/day
                                                      based on reduced
                                                      body weight and
                                                      body weight gains
                                                      (males), decreased
                                                      absolute and
                                                      relative liver
                                                      weights (males and
                                                      females).
                                                      Oncogenic NOAEL
                                                       586 mg/
                                                      kg/day, no
                                                      evidence of
                                                      carcinogenicity.
------------------------------------------------------------------------
870.4300                         Carcino-genicity    Systemic NOAEL =
                                  mice - diet         735 (M) and 168
                                                      (F) mg/kg/day,
                                                      Systemic LOAEL =
                                                      3333 (M) and 839
                                                      (F) mg/kg/day
                                                      based on decreased
                                                      body weight gains.
                                                      Oncogenic NOAEL
                                                       3676
                                                      mg/kg/day, no
                                                      evidence of
                                                      carcinogenicity
------------------------------------------------------------------------

[[Page 10820]]

 
870.5375                         Gene Mutation In    Positive finding,
                                  vitro Chromosomal   flutolanil induced
                                  Aberration Assay    chromosomal
                                  in Cultured         aberrations in
                                  Mammalian Cell      cultured Chinese
                                                      hamster lung cells
                                                      in the presence of
                                                      metabolic
                                                      activation (S9).
------------------------------------------------------------------------
870.5100                         Gene Mutation,      Negative (with and
                                  Reverse Mutation    without S-9
                                  Assay               metabolic
                                                      activator) at
                                                      doses up to 25 mg/
                                                      plate in the
                                                      increase in
                                                      revertant colonies
                                                      using Salmonella
                                                      strains TA98,
                                                      TA10, TA1535,
                                                      TA1537, and TA1538
                                                      and in the E. Coli
                                                      WP2 uvrA strain.
------------------------------------------------------------------------
870.5375                         Gene Mutation in    Negative (either in
                                  Cultured            the presence or
                                  Mammalian Cells     absence of S9
                                  (Mouse Lymphoma     activation) for
                                  Cells)              the induction of
                                                      forward mutations
                                                      at the TK+/- locus
                                                      in L5178Y mouse
                                                      lymphoma cells.
------------------------------------------------------------------------
 870.5385                        Cytogenetics        Negative in the
                                  Mammalian Cells     structural
                                  in Culture          chromosome assay.
                                  Cytogenetics        There was no
                                  Assay in Human      significant
                                  Lymphocytes         increase in the
                                                      frequency of
                                                      aberrations with
                                                      any treatment
                                                      levels, either
                                                      with or without
                                                      activation.
------------------------------------------------------------------------
870.5395                         Cytogenetics Mouse  Negative in the
                                  Micronucleus        induction of
                                                      micronuclei in the
                                                      bone marrow
                                                      erythrocytes of
                                                      male and female
                                                      mice.
------------------------------------------------------------------------
870.5550                         Other Genotoxicity  Negative in the
                                  Effects, In Vitro   induction of
                                  Unscheduled DNA     unscheduled DNA
                                  Synthesis Assays    synthesis in
                                  in Primary Rat      primary rat
                                  Hepatocytes         hepatocytes.
------------------------------------------------------------------------
870.6200a                        Acute               Not available
                                  neurotoxicity
                                  screening battery
------------------------------------------------------------------------
870.6200b                        Subchronic          Not available
                                  neurotoxicity
                                  screening battery
------------------------------------------------------------------------
870.6300                         Developmental       Not available
                                  neurotoxicity
------------------------------------------------------------------------
870.7485                         Metabolism and      Treatment was oral
                                  pharmacokinetics -  doses of 20 mg/kg/
                                   rat                day for 14 days,
                                                      and a single high
                                                      dose of 1,000 mg/
                                                      kg. The majority
                                                      of the
                                                      radioactivity
                                                      excreted in urine
                                                      had been excreted
                                                      by 24 hours post-
                                                      dose in all dose
                                                      groups. There were
                                                      no appreciable
                                                      tissue levels of
                                                      flutolanil at
                                                      study termination
                                                      (72 hours post-
                                                      dose).
------------------------------------------------------------------------
870.7600                         Dermal penetration  Not available
------------------------------------------------------------------------

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.
    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, as shown in following Table 2:

      Table 2.--Summary of Toxicological Dose and Endpoints for Flutolanil 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 general population       None                     No appropriate endpoint  None
 including infants and children                                  was identified in the
                                                                 oral toxicity studies
                                                                 including
                                                                 developmental toxicity
                                                                 studies in rats and
                                                                 rabbits.
----------------------------------------------------------------------------------------------------------------

[[Page 10821]]

 
Chronic Dietary all population         NOAEL= 87 mg/kg/day UF   FQPA SF = 1 x            2-year Chronic/
 subgroups                              = 100 Chronic RfD =      cPAD = chronic RfD       Oncogenicity study in
                                        0.87 mg/kg/day           FQPA SF = 0.87 mg/kg/    rats. LOAEL = 460 mg/
                                                                 day.                     kg/day based on
                                                                                          decreases in body
                                                                                          weight and body weight
                                                                                          gain and increases in
                                                                                          absolute and relative
                                                                                          liver weights.
----------------------------------------------------------------------------------------------------------------
Short (1 to 7 days) -and Intermediate- None                     No appropriate endpoint  None
 (1 week to several months)- Term                                was identified. No
 Dermal (Residential)                                            dermal or systemic
                                                                 toxicity was observed
                                                                 in a 21-day dermal
                                                                 study in rats. No
                                                                 maternal toxicity was
                                                                 observed in rats or
                                                                 rabbits in
                                                                 developmental toxicity
                                                                 studies.
----------------------------------------------------------------------------------------------------------------
Long-Term Dermal (several months to    None                     The current use pattern  None
 lifetime)                                                       does not indicate long-
                                                                 term dermal exposure
                                                                 potential.
----------------------------------------------------------------------------------------------------------------
Inhalation (any time period)           Oral NOAEL= 87 mg/kg/    LOC  100      2-year Chronic/
                                        day (inhalation                                   Oncogenicity study in
                                        absorption rate =                                 rats. LOAEL = 460 mg/
                                        100%)                                             kg/day based on
                                                                                          decreases in body
                                                                                          weight and body weight
                                                                                          gain and increases in
                                                                                          absolute and relative
                                                                                          liver weights
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      None                     Based on the lack of     None
                                                                 evidence of
                                                                 carcinogenicity and
                                                                 mutagenicity in mouse
                                                                 and rat studies,
                                                                 flutolanil is
                                                                 classified as not
                                                                 likely to cause
                                                                 cancer.
----------------------------------------------------------------------------------------------------------------
* 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. Tolerances have been 
established (40 CFR 180.484) for the residues of flutolanil, N-(3-(1-
methylethoxy)phenyl)-2-(trifluoromethyl)benzamide and metabolites 
converted to 2-(trifluoromethyl) benzoic acid, calculated as flutolanil 
and its metabolites in or on the raw agricultural commodities peanuts, 
peanut meal, peanut hay; milk; fat; kidney; liver; meat and meat-by-
product (mbyp) of cattle, goats, hogs, horses, and sheep; eggs; fat; 
meat; and mbyp of poultry. Time-limited tolerances, made permanent by 
today's rule, are established for residues of flutolanil and its 
metabolites in/on rice RACs.
    Risk assessments were conducted by EPA to assess dietary exposures 
from flutolanil and its metabolites 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. A toxicological endoint for acute dietary toxicity 
was not selected for flutolanil. Therefore, a risk assessment for 
dietary food exposure was not conducted.
    ii. Chronic exposure.In conducting this chronic dietary risk 
assessment 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 chronic exposure 
assessments: that residues would be present in or on treated crops at 
tolerance levels and that 100% of proposed and currently registered 
crops would be treated.
    iii. Cancer. Flutolanil is unlikely to pose a carcinogenic hazard 
to humans. Therefore a cancer risk assessment was not conducted.
    2. Dietary exposure from drinking water. Flutolanil resists all 
modes of abiotic and biotic degradation. Flutolanil is mobile in soil 
but was found in aquatic field dissipation studies to accumulate in the 
sediment fraction. Because flutolanil adsorbs at low rates onto soil 
and exhibits a long half-life, the most important means of dissipation 
in surface water and also in ground water will most likely be dilution.
    The Agency lacks sufficient monitoring exposure data to complete a 
comprehensive dietary exposure analysis and risk assessment for 
flutolanil 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 flutolanil.
    The Agency used the First Approximation Rice Model to estimate 
pesticide concentrations in surface water after applying flutolanil on 
rice and Screening Concentrations in Ground Water (SCI-GROW), which 
predicts pesticide concentrations in groundwater. In general, EPA will 
use Generic Expected Environmental Concentrations (GENEEC) (a tier 1 
model) before using Pesticide Root Zone/Exposure Analysis Modeling 
System (PRZM/EXAMS) (a tier 2 model) for a screening-level assessment 
for surface water, but given the unique

[[Page 10822]]

hydrological issues arising from pesticide application to rice paddies, 
EPA used the First Approximation Rice Model rather than GENEEC or PRZM/
EXAMS for surface water estimates.
    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 flutolanil they are further 
discussed in the aggregate risk sections below.
    Based on the First Approximation Rice Model and SCI-GROW model, the 
estimated environmental concentrations (EECs) of flutolanil for acute 
exposures are 3.8 parts per billion (ppb) for surface water and 0.34 
ppb for ground water. The EECs for chronic exposures are 3.8 ppb for 
surface water and 0.34 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).
    Flutolanil is currently registered for use on the following 
residential non-dietary sites: Turf grass. The risk assessment was 
conducted using the following residential exposure assumptions: There 
are non-occupational uses associated with flutolanil. Non-occupational 
handlers may mix, load and apply flutolanil products on turf grass. 
These exposures were assessed for inhalation risk. The MOEs for these 
scenarios range from 1.4 x 103 to 4.4x 104 for 
handlers. Postapplication inhalation exposure following turf grass 
treatment is considered negligible and was not assessed. Because 
certain flutolanil products are registered for use on residential 
lawns, postapplication exposure to infants may result from their hand-
to-mouth activities on treated turf. The MOE's for these scenarios 
ranged from 6.7 x 102 to 1.4 x 103. These MOEs 
are greater than the LOC of 100 and lie above the Agency's level of 
concern.
    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 flutolanil 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, 
flutolanil 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 flutolanil 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. Developmental toxicity 
studies in rat and rabbit and multigeneration reproductive studies in 
rat did not indicate any basis for concern about prenatal and postnatal 
effects in infants and children.
    3. Conclusion. There is a complete toxicity data base for 
flutolanil and exposure data are complete or are estimated based on 
data that reasonably accounts for potential exposures and the 
developmental and reproductive toxicity studies indicate no increased 
susceptibility of rat or rabbit fetuses to in utero or post-natal 
exposure. Accordingly, EPA determined that the 10X safety factor to 
protect infants and children should be removed.

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

[[Page 10823]]

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. Acute aggregate risk is based upon the estimated 
risks from the combined exposures of food and drinking water sources. 
EPA did not recommend an acute dietary endpoint for flutolanil, 
therefore no acute aggregate risk assessment was conducted and there is 
no expectation of acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
flutolanil from food will utilize < 1.0% of the cPAD for the U.S. 
population, 1.0% of the cPAD for infants less than one year old and < 
1.0% of the cPAD for all other population subgroups.
    Based on the use pattern, chronic residential exposure to residues 
of flutolanil is not expected. In addition, there is potential for 
chronic dietary exposure to flutolanil 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 3:

               Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to flutolanil
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/     % cPAD     Water EEC    Water EEC       DWLOC
                                                     day         (Food)       (ppb)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population                                         0.87      < 1.0 %          3.8         0.34    3.0 x 104
----------------------------------------------------------------------------------------------------------------
Infants less than one year old                          0.87         1.0%          3.8         0.34    8.6 x 103
----------------------------------------------------------------------------------------------------------------
Non-hispanic/non-white/non-black                        0.87      < 1.0 %          3.8         0.34    3.0 x 104
----------------------------------------------------------------------------------------------------------------
Females 13-50 (nursing)                                 0.87      < 1.0 %          3.8         0.34    2.6 x 104
----------------------------------------------------------------------------------------------------------------

    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).
    Though residential exposure could occur with the use of flutolanil 
no toxicological effects have been identified for short-term dermal 
toxicity. Incidental oral exposure to adult residential handlers is 
expected to be insignificant and is therefore not assessed. Incidental 
oral exposure to infants eating treated turf is assessed below under 
intermediate-term aggregate risk.
    4. Intermediate-term risk. Flutolanil is currently registered for 
use(s) that could result in intermediate-term residential exposure and 
the Agency has determined that it is appropriate to aggregate chronic 
food and water and intermediate-term exposures for flutolanil.
    Using the exposure assumptions described in this unit for 
intermediate-term exposures, EPA has concluded that food and 
residential exposures aggregated result in aggregate MOEs of 1.3 x 
103 for the hand-to-mouth exposure of an infant following 
application of turf with a granular formulation of flutolanil and 6.4 X 
102 for the hand-to-mouth exposure of an infant following 
application with a wettable powder. These aggregate MOEs exceed 100, 
the Agency's maximum level of concern for aggregate exposure to food 
and residential uses. In addition, intermediate-term DWLOCs were 
calculated and compared to the EECs for chronic exposure of flutolanil 
in ground and surface water. After calculating DWLOCs and comparing 
them to the EECs for surface and ground water, EPA does not expect 
intermediate-term aggregate exposure to exceed the Agency's level of 
concern, as shown in the following Table 4:

           Table 4.--Aggregate Aggregate Risk Assessment for Intermediate-Term Exposure to Flutolanil
----------------------------------------------------------------------------------------------------------------
                                                         Aggregate
                                       Aggregate MOE      Level of     Surface       Ground    Intermediate-Term
        Population Subgroup               (Food +         Concern     Water EEC    Water EEC      DWLOC (ppb)
                                        Residential)       (LOC)        (ppb)        (ppb)        ground water
----------------------------------------------------------------------------------------------------------------
Infants < 1 year old, hand-to-mouth          1.3 x 103          100         0.34          3.8          8.0 x 103
 exposure to granular
----------------------------------------------------------------------------------------------------------------
Infants < 1 year old, hand-to-mouth          6.4 x 102          100         0.34          3.8          7.3 x 103
 exposure to wettable powder
----------------------------------------------------------------------------------------------------------------

    5. Aggregate cancer risk for U.S. population. Flutolanil is 
classified as a ``not likely'' to be a human carcinogen considering the 
Proposed EPA Weight-of-the-Evidence Categories (August, 1999), based on 
the lack of evidence of carcinogenicity in male and female rats and 
mice up to the guideline limit dose and on the lack of mutagenicity in 
an acceptable battery of mutagenicity studies.
    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 flutolanil residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The petitioner has proposed a residue analytical method for 
tolerance enforcement involving the transformation of flutolanil and 
its metabolites to 2-trifluoromethyl benzoic acid (2-TFBA). The organic 
extracts containing 2-TFBA are methylated with methyl iodide and 
residues are

[[Page 10824]]

quantified by gas chromatography utilizing a mass selective detector. 
The analytical method designated AU-9SR-04 has been independently 
validated. EPA review of the validation determined it to be adequate 
for enforcement purposes. Upon successful completion of the EPA 
validation process, this method will be forwarded to FDA for 
publication in a future version of the Pesticide Analytical Manual, Vol 
II (PAM II).
    The method may be requested from: Calvin Furlow, PRRIB, 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 established or proposed Codex, Canadian or Mexican 
limits for residues of flutolanil in/on plant or animal commodities. 
Therefore, no compatibility issues exist with regard to the proposed 
U.S. tolerances discussed in this petition review.

C. Conditions

    Flutolanil will be conditionally registered for these uses subject 
to the following conditions:
    1. Modification of the proposed enforcement method as directed by 
the Agency once the validation is completed.
    2. Fortification recovery data for flutolanil and its metabolites 
from potato and radiovalidation data from all previously submitted 
metabolism studies.
    3. Confirmatory method which is able to confirm that the residues 
determined in the primary method (proposed enforcement method (Method 
No. AU/95R/05), a common moiety method and determining all residues 
(parent plus metabolites) containing the 2-(trifluoromethyl) benzoic 
acid moiety) were derived from flutolanil.
    4. Storage stability data for residues of flutolanil and 
representative metabolites in/on potatoes and potato processed 
commodities during frozen storage.
    5. Storage stability data related to an already-submitted study 
concerning the uptake of residues in crops irrigated with water drained 
from treated rice fields, specifically for residues of flutolanil and 
representative metabolites in/on irrigated cotton, turnips, and 
soybeans for a period of up to 426 days.
    6. An additional poultry feeding study in which the dose levels 
exceed those used in previously submitted studies.

V. Conclusion

    Therefore, the tolerance is established for residues of flutolanil, 
N-(3-(1-methylethoxy)phenyl)-2-(trifluoromethyl)benzamide and 
metabolites converted to 2-(trifluoromethyl) benzoic acid, calculated 
as flutolanil, in or on the raw agricultural commodities potatoes at 
0.20 part per million ppm, rice, grain at 7.0 ppm, rice, straw at 10.0 
ppm, and in or on the processed food commodities potato, wet peel at 
0.3 ppm, rice, hulls at 25.0 ppm, and rice bran at 10.0 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-301094 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 April 23, 
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-301094, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental

[[Page 10825]]

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 file format 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 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 prior consultation as specified by Executive Order 
13084, entitled Consultation and Coordination with Indian Tribal 
Governments (63 FR 27655, May 19, 1998); special considerations as 
required by Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994); or require 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 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 FFDCA section 408(n)(4).

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: December 15, 2000.

Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--AMENDED]

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

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

    2. Section 180.484 is amended by alphabetically adding commodities 
to the table in paragraph (a)(1) to read as follows:


Sec. 180.484   Flutolanil, N-(3-(1-methylethoxy)phenyl)-2-
(trifluoromethyl) benzamide; tolerances for residues.

    (a)(1) General. *  *  *  

[[Page 10826]]



----------------------------------------------------------------------------------------------------------------
                            Commodity                                            Parts per million
----------------------------------------------------------------------------------------------------------------
 *                  *                  *                  *                  *                  *
                                                         *
 
Potato...........................................................                                           0.20
Potato, wet peel.................................................                                           0.30
 
 *                  *                  *                  *                  *                  *
                                                         *
 
Rice, bran.......................................................                                           10.0
Rice, grain......................................................                                            7.0
Rice, hulls......................................................                                           25.0
Rice, straw......................................................                                           10.0
 *                  *                  *                  *                  *                  *
                                                         *
----------------------------------------------------------------------------------------------------------------

* * * * *

[FR Doc. 01-2047 Filed 2-16-01; 8:45 am]
BILLING CODE 6560-50-S