FLUORIDE ACTION NETWORK PESTICIDE PROJECT
Return to FAN's Pesticide Homepage
Return to Flutolanil Index Page
Flutolanil (Aventis). February 20, 2001, Pesticde Tolerances. Final Rule. Federal Register.
http://www.epa.gov/fedrgstr/EPA-PEST/2001/February/Day-20/p2047.htm
[Federal Register: February 20, 2001 (Volume 66, Number 34)]
[Rules and Regulations]
[Page 10817-10826]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20fe01-10]
=======================================================================
-----------------------------------------------------------------------
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:
waller.mary@epa.gov.
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 ³ 1,000 mg/
rat, oral gavage kg/day, LOAEL >
1,000 mg/kg/day,
Developmental
NOAEL ³
1,000 mg/kg/day,
LOAEL > 1,000 mg/
kg/day.
------------------------------------------------------------------------
870.3700b Prenatal Maternal NOAEL ³ 1,000 mg/
rabbit, oral kg/day, LOAEL >
gavage 1,000 mg/kg/day,
Developmental
NOAEL ³
1,000 mg/kg/day,
LOAEL > 1,000 mg/
kg/day.
------------------------------------------------------------------------
870.3800 Reproduction and Parental/Systemic
fertility effects NOAEL ³
in rat - 2 1,000 mg/kg/day,
generation - diet LOAEL > 1,000 mg/
kg/day,
Reproductive NOAEL
³ 1,000
mg/kg/day, LOAEL >
1,000 mg/kg/day.
------------------------------------------------------------------------
870.3800 Reproduction And Parental/Systemic
Fertility Effects NOAEL ³
In Rat - 3 661 mg/kg/day,
Generation - diet LOAEL > 661 mg/kg/
day, Reproductive
NOAEL ³
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
³ 586 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
³ 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 ³ 100 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: furlow.calvin@epa.gov.
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 tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
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: opp-docket@epa.gov. Please use an ASCII file
format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 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