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Tolylfluanid (Bayer). September 25,
2002. Classified as Likely to be carcinogenic to humans.
EPA approves Pesticide
Tolerances in
or on imported apple, grape, hop, tomato. Federal
Register. Final
Rule.
http://www.epa.gov/fedrgstr/EPA-PEST/2002/September/Day-25/p24094.htm
[Federal Register: September 25, 2002 (Volume 67, Number 186)]
[Rules and Regulations]
[Page 60130-60142]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25se02-7]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2002-0216; FRL-7200-5]
Tolylfluanid; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes an import tolerance for residues
of tolylfluanid in or on imported apple, grape, hop, and tomato. Bayer
Corporation requested this tolerance under the Federal Food, Drug, and
Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act
(FQPA) of 1996.
DATES: This regulation is effective September 25, 2002. Objections and
requests for hearings, identified by docket ID number OPP-2002-0216,
must be received on or before November 25, 2002.
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 ID number OPP-2002-0216 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-
0001; telephone number: (703) 308-9354; 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/. A frequently updated electronic
version of 40 CFR part 180 is available at http://www.access.gpo.gov/
nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, 
a beta site currently
under development. 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 ID number OPP-2002-0216. 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 August 11, 1997 (62 FR 42980) (FRL-5736-
1), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C.
346a, as amended by FQPA (Public Law 104-170), announcing the filing of
a pesticide petition (PP 7E4825) by Bayer Corporation, 8400 Hawthorn
Rd., Kansas City, MO 64120. This notice included a summary of the
petition prepared by Bayer Corporation, the registrant. There were no
comments received in response to the notice of filing.
The petition requested that 40 CFR 180.584 be amended by
establishing an import tolerance for residues of the fungicide
tolylfluanid, (1,1-dichloro-N-[(dimethylamino)-sulfonyl]-1-fluoro-N-(4-
methylphenyl) methanesulfenamide), in or on apple at 5.0 parts per
million (ppm), grape at 5.0 ppm, hop at 30 ppm, and tomato at 1.0 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) of the FFDCA defines ``safe'' to mean that ``there is
a reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including
[[Page 60131]]
all anticipated dietary exposures and all other exposures for which
there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Section 408(b)(2)(C) of the FFDCA requires EPA
to give special consideration to exposure of infants and children to
the pesticide chemical residue in establishing a tolerance and to
``ensure that there is a reasonable certainty that no harm will result
to infants and children from aggregate exposure to the pesticide
chemical residue....''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see the final rule on
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed
the available scientific data and other relevant information in support
of this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of the FFDCA, for a tolerance for residues of tolylfluanid in
or on apple at 5.0 ppm, grape at 11 ppm, hop at 30 ppm, and tomato at
2.0 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 tolylfluanid are
discussed in Table 1 of this unit 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
------------------------------------------------------------------------
870.3100 90-Day oral NOAEL = 20.1
toxicity rodents milligram/kilogram/
(rat) day (mg/kg/day) male
(M)
LOAEL = 108 mg/kg/
day, based on
changes in clinical
blood chemistry
associated with the
liver and thyroid
(M)
NOAEL = 131 mg/kg/day
female (F)
LOAEL = 736.1 mg/kg/
day, based on
changes in clinical
blood chemistry
associated with the
liver and thyroid
and decreased body
weights (F)
Acceptable/guideline
-------------------------------
870.3150 90-Day oral NOAEL = 23.1/25 mg/kg/
toxicity in day (F/M)
nonrodents (dog) LOAEL = 67.2/69.4 (F/
M) mg/kg/day, based
on decreased body
weight gains and
changes in liver
structure and
function in both
sexes
Unacceptable/
guideline
-------------------------------
870.3700 Prenatal Maternal NOAEL = not
developmental in determined
rodents (rat) LOAEL = 100 mg/kg/
day, based on
decreased body
weight gains and
food consumption.
Developmental NOAEL =
1,000 mg/kg/day
highest dose tested
(HDT)
LOAEL > 1,000 mg/kg/
day
Acceptable/guideline
-------------------------------
870.3700 Prenatal Maternal NOAEL = 100
developmental in mg/kg/day
rodents (rat) LOAEL = 300 mg/kg/
day, based on dose-
related decreased
body weight gains
during the dosing
interval.
Developmental NOAEL >
1,000 mg/kg/day
(HDT)
LOAEL = not
identified
Acceptable/guideline
-------------------------------
870.3700 Prenatal Maternal NOAEL = 25
developmental in mg/kg/day
nonrodents LOAEL = 70 mg/kg/day,
(rabbit) based on evidence of
hepatotoxicity
(increased glutamate
dehydrogenase (GLDH)
and triglyceride
levels and gross and
microscopic liver
pathology) and
decreased food
consumption and
equivocal decreases
in body weight gain.
Developmental NOAEL =
25 mg/kg/day
LOAEL= 70 mg/kg/day,
based on increased
malformations
(arthrogryposis of
front extremities
and small orbital
cavity/folded
retina) and
variations (floating
rib and accelerated
ossification).
Acceptable/guideline
-------------------------------
[[Page 60132]]
870.3800 2-Generation Parental/systemic
reproduction and NOAEL = 7.9-10.5 mg/
fertility kg/day
effects (rat) LOAEL = 57.5-78.0 mg/
kg/day, based on
decreased body
weights, body weight
gains, and liver
weights in the P
females
Reproductive NOAEL =
7.9-10.5 mg/kg/day
LOAEL = 57.5-78.0 mg/
kg/day, based on
reduced litter size
Offspring NOAEL = 7.9-
10.5 mg/kg/day
LOAEL = 57.5-78.0 mg/
kg/day, based on
decreased pup
weights, increased
pup deaths and
related pup
viability indices
Acceptable/guideline
-------------------------------
870.3800 2-Generation Parental/systemic
reproduction and NOAEL not
fertility established
effects (rat) LOAEL = 15.9-21.5 mg/
kg/day, based on
hardened crania of P
generation animals
Reproductive NOAEL
not established
LOAEL = 15.9-21.5 mg/
kg/day, based on
increased clinical
signs of toxicity
Offspring NOAEL >
15.9-21.5 mg/kg/day
(HDT)
LOAEL not established
Unacceptable/
guideline
-------------------------------
870.3800 2-Generation Parental/Systemic
reproduction and NOAEL = 20.1-26.3 mg/
fertility kg/day
effects (rat) LOAEL = 83.4-109.5 mg/
kg/day, based on
decreased body
weights and body
weight gains
Reproductive NOAEL =
83.4 - 109.5 mg/kg/
day
LOAEL = 335.6-492.4
mg/kg/day, based on
decreased mean
litter size
Offspring NOAEL =
20.1-26.3 mg/kg/day
LOAEL = 83.4-109.5 mg/
kg/day, based on
decreased pup
weights
Acceptable/guideline
-------------------------------
870.3800 2-Generation Parental/Systemic
reproduction and NOAEL = 75 mg/kg/day
fertility LOAEL = 375 mg/kg/
effects (rat) day, based on
decreased body
weights and body
weight gains for
both generations
Reproductive NOAEL >
375 mg/kg/day (HDT)
LOAEL not established
Offspring NOAEL = 75
mg/kg/day
LOAEL = 375 mg/kg/
day, based on
decreased survival
and reduced body
weights during
lactation
Acceptable/guideline
-------------------------------
870.4300 Combined chronic NOAEL = 18.1/21.1 mg/
toxicity/ kg/day (M/F)
carcinogenicity LOAEL = 90.1/105.2 mg/
rodents (rat) kg/day (M/F), based
on skeletal changes
Evidence of thyroid
follicular cell
adenomas and/or
carcinomas in high-
dose males and
females
Acceptable/guideline
-------------------------------
870.4300 Combined chronic NOAEL = 20/20 mg/kg/
toxicity/ day (M/F)
carcinogenicity LOAEL = 80/110 mg/kg/
rodents (rat) day (M/F), based on
bone hyperostosis in
males and females
Evidence of thyroid
follicular cell
adenomas and/or
carcinomas in high-
dose males and
females
Acceptable/guideline
-------------------------------
870.4200 Carcinogenicity NOAEL = 76.3/123.9 mg/
rodents (mouse) kg/day (M/F)
LOAEL = 375.8/610.8
mg/kg/day (M/F),
based on skeletal,
liver, and kidney
changes
No evidence of
carcinogenicity
Acceptable/guideline
-------------------------------
870.4100 Chronic toxicity NOAEL = 12.5 mg/kg/
(dog) day
LOAEL = 62.5 mg/kg/
day (M), based on
decreased body
weight gains
Acceptable/guideline
-------------------------------
870.5100 Bacterial gene Tolylfluanid was
Technical..................... mutation assay cytotoxic to all
strains at = 8 [mu]g/plate +/
- S9 and
precipitated from
solutions in all
strains at 5,000
[mu]g/plate +/- S9.
There were no
reproducible, dose-
related differences
in the number of
revertant colonies
in any strain or
dose over the
background. Positive
controls induced
appropriate
response.
Acceptable/guideline
-------------------------------
[[Page 60133]]
870.5100 Bacterial gene There was no evidence
Metabolite--WAK 5815.......... mutation assay of toxicity or
significant increase
in mutant colonies
over background in
any of strains
tested in either the
initial or repeat
mutagenicity assays.
Positive controls
induced appropriate
response.
Acceptable/guideline
-------------------------------
870.5100 Bacterial gene There were no
Metabolite--WAK 6550.......... mutation assay reproducible, dose-
related differences
in the number of
revertant colonies
in any strain or
dose over the
background. Positive
controls induced
appropriate
response.
Acceptable/guideline
-------------------------------
870.5100 Bacterial gene There was no evidence
Metabolite--WAK 6676.......... mutation assay of toxicity or
significant increase
in the mutant
colonies over
background in any
strain tested.
Positive controls
induced the
appropriate
responses in the
corresponding
strains and in the
solvent controls
were consistent with
the expected ranges
of revertant
colonies for the
strains used.
Acceptable/guideline
-------------------------------
870.5100 Bacterial gene Metabolite was
Metabolite--WAK 6698.......... mutation assay cytotoxic at doses
£=158
[mu]g/plate in the
initial assay and
1,581 [mu]g/plate in
the repeat assay.
There was no
evidence of a
significant increase
in mutant colonies
over background in
any strains tested
in the initial or
repeat mutagenicity
assays. Positive
controls induced
appropriate
response.
Acceptable/guideline
-------------------------------
870.5100 Bacterial gene Tolylfluanid was
Technical..................... mutation assay tested to cytotoxic
concentrations.
Tolylfluanid showed
no evidence of
inducing methionine
revertants in
Saccharomyces
cerevisiae strains +/
- S9. However, one
of the tests
(S211[
]) was inadequate
or inconsistent.
Further, in the S9
activated assays,
the positive
controls did not
elicit an adequate
response, negating
the test with S9 for
both strains.
Unacceptable/
guideline
-------------------------------
870.5300 In vitro The compound was
Metabolite-- WAK 6698......... mammalian cell tested up to
gene mutation cytotoxic
assay concentrations in
two independent
assays (+/- S9). In
the initial test
concentrations
ranged from 50 to
1,000 [mu]g/mL +/-
S9. In the repeat
assay concentrations
ranged from 100 to
800 [mu]g/mL -S9 and
200 to 700 [mu]g/mL
+ S9. Tolylfluanid
metabolite was
negative for
inducing forward
mutations at the TK
locus in mouse
L5178Y +/- S9.
Positive control
methyl
methanosulfonate and
3-methylcholanthrene
induced appropriate
responses.
Acceptable/guideline
-------------------------------
870.5300 In vitro These dose levels
Technical..................... mammalian cell were selected based
gene mutation on a preliminary
assay cytotoxicity study
conducted at 0.5 to
250 [mu]g/mL +/- S9.
Tolylfluanid has
been judged to be
non-mutagenic +/-
S9. Positive
controls induced
appropriate response
+/- S9.
Acceptable/guideline
-------------------------------
870.5300 In vitro Cultures were tested
Technical..................... mammalian cell to cytotoxic
gene mutation concentrations.
assay Tolylfluanid has
been judged to be
non-mutagenic +/-
S9. Positive
controls induced
appropriate response
+/- S9.
Acceptable/guideline
-------------------------------
870.5300 In vitro The compound was
Technical..................... mammalian cell tested up to
gene mutation cytotoxic
assay concentrations (+/-
S9). Tolylfluanid
was positive for
inducing forward
mutations at the TK
locus in mouse
L5178Y +/- S9.
Positive control
ethylmethane
sulfonate and 3-
methylcholanthrene
induced appropriate
responses. Colony
sizing was not
performed.
Acceptable/guideline
-------------------------------
Non-Guideline Mouse spot test F1 pups from female
Technical..................... C57B1/6J mice
exposed by oral
gavage to
tolylfluanid (98.4%)
at concentration of
0; 1,750; 3,500; and
7,000 mg/kg did not
show difference in
incidence in
relative spots
between the treated
and controls.
Systemic toxicity
was observed in dams
at all doses.
Mortality was
observed at all
doses; however
treatment did not
affect reproductive
parameters nor there
was difference in
litter size.
Positive controls
showed a clear
increase in spots in
the progeny.
Acceptable/non-
guideline
-------------------------------
[[Page 60134]]
870.5375 In vitro The test was
Technical..................... mammalian cell conducted up to
gene mutation cytotoxic levels +/-
assay S9. Tolylfluanid was
weakly clastogenic
in Chinese hamster
V79 cells in the
presence of S9
activation. Positive
control mitomycin
and cyclophosphamide
induced appropriate
responses.
Acceptable/guideline
-------------------------------
870.5375 In vitro Cytotoxicity was
Technical..................... mammalian cell observed at
gene mutation concentrations 1 to
assay 10 [mu]g/milliliter
(mL) -S9 and 5 to 10
[mu]g/mL +S9. Over
the ranges tested
clastogenic effects
included increased
incidences of
metaphases with
aberrations
including gaps,
metaphases excluding
gaps, metaphases
with exchanges, and
metaphases with
polyploidy were
observed.
Tolyfluanid is
clastogenic both in
the presence and in
the absence of S9
activation. Positive
control mitomycin
and endoxan induced
appropriate
responses.
Acceptable/guideline
-------------------------------
870.5380 In vitro No mortality or
Technical..................... mammalian clinical signs were
spermatogonia observed at either
chromosomal dose. No
aberration test statistically
significant
increases in the
frequency of
chromosomal
aberrations in
spermatogonia were
observed.
Unacceptable/
guideline
-------------------------------
870.5380 In vitro Clinical signs of
Technical..................... mammalian toxicity and
spermatogonia cytotoxicity to
chromosomal target cells were
aberration test seen at 5,000 mg/kg/
day. Tolylfluanid
did not induce
chromosomal
aberrations in
spermatogonia at any
dose. Positive
controls did not
produce strong
positive results.
Therefore,
sensitivity of assay
is questionable and
the findings of the
study are equivocal.
Unacceptable/
guideline
-------------------------------
870.5385 Mammalian bone 3/10 animals died but
Technical..................... marrow exhibited no
chromosomal clinical signs. No
aberration test cytotoxicity was
observed at the dose
tested. Positive
controls induced
appropriate
response. Inadequate
sampling time and no
indication of test
material present at
target site;
therefore, data not
valid for regulatory
purposes.
Unacceptable/
guideline
-------------------------------
870.5385 Mammalian bone 3/10 of 10 animals
Technical..................... marrow died but no clinical
chromosomal signs of toxicity
aberration test were observed at the
dose tested. Test
results were
erratic. Positive
controls induced
appropriate
response. Inadequate
study since test
samples were not
analyzed and doses
were not high enough
to produce toxicity.
Unacceptable/
guideline
-------------------------------
870.5395 Mammalian No clinical signs of
Technical..................... erythrocyte toxicity was
micronucleus observed and was not
assay toxic to the target
tissue. Treatment
with tolylfluanid
did not induce
micronucleated
polychromatic
erythrocytes.
Inadequate methods
and methodology.
Unacceptable/
guideline
-------------------------------
870.5450 Dominant lethal Did not induce
Technical..................... assay (mice) variations in any
dominant lethal
parameters nor any
reduced fertility.
Inadequate study.
No positive control
data
Unacceptable but
upgradable with
receipt of positive
control data
-------------------------------
870.5915 In vivo sister Mortality at 500 mg/
Technical..................... chromatid kg and above.
exchange assay Tolylfluanid did not
induce sister
chromatid exchange
at any dose level.
Positive control
cyclophosphamide
responded
appropriately.
Acceptable/guideline
-------------------------------
870.5500 Other genotoxic Tolylfluanid did not
Technical..................... effects induce UDS up to
unscheduled DNA 15.0 [mu]g/mL. The
synthesis (UDS) 17.5 and 20 [mu]g/mL
in mammalian doses were highly
cells toxic. The positive
control 2-
acetylaminofluorene
responded
appropriately.
Acceptable/guideline
-------------------------------
870.6200 Acute NOAEL = 50 mg/kg in
neurotoxicity females
screening LOAEL = 150 mg/kg/day
battery (rat) based on functional
observation battery
(FOB) effects and
decreased motor and
locomotor activity
in females
NOAEL = 2,000 mg/kg/
day (M)--limit dose
LOAEL = not
established (M)
Acceptable/guideline
-------------------------------
[[Page 60135]]
870.6200 Subchronic NOAEL = 25 mg/kg (F)
neurotoxicity LOAEL = 134 mg/kg
screening based on decreased
battery (rat) mean body weights in
females.
No treatment-related
neurotoxicological
effects were
observed at any
treatment level.
Acceptable/guideline
-------------------------------
870.7485 Metabolism and In a metabolism study
pharmacokinetics in rats,
(rat) tolylfluanid was
administered in
single doses of 2 or
100 mg/kg of body
weight, was readily
absorbed and rapidly
hydrolyzed within 48
hours. Absorption
and excretion were
independent of dose,
sex, and
pretreatment. About
86-100% of the dose
was recovered in 48
hours, with 56-80%
of the dose being
excreted in urine,
12-36% in the feces,
and <= 0.48% found
in the carcass.
Urinary metabolite
common to both sexes
were
dimethylaminosulfony
lamino-benzoic acid
(RNH 0166; 46-78%),
and 4-methylamino-
benzoic acid (RNH
0416; 3-6%). Fecal
compounds identified
were unchanged
tolylfluanid (1-
19%),
dimethylaminosulfoto
luidid (DMST; 5-8%),
RNH 0166 (3-12%),
and RNH 0416 (< 1%).
The data indicate
that tolylfluanid
hydrolyzed to DMST,
which is then
transformed to the
major metabolite RNH
0166, which can be
further demethylated
to the minor
metabolite, RNH 0416
(MRID No. 44285805).
Acceptable/guideline
-------------------------------
870.7485 Metabolism and Series of metabolism
pharmacokinetics studies showed that
(rat) metabolic profile
dependent upon label
position. With
[dichlorofluoromethy
l-\14\C]-
tolylfluanid
labeling major
urinary metabolite
was thiazolidine-2-
thione-4carbonic
acid resulting from
cleavage of the side
chain and accounted
for 73-74% and 50-
63%, respectively by
IV and oral routes.
Benzene ring label
resulted in
metabolite 4-
(dimethylamino-
sulfonylamino)
benzoic acid which
accounted for 90% of
urinary metabolic
activity and 70% of
fecal radioactivity.
The study with
single oral dose of
2 or 20 mg/kg/day
also supported the
results of the main
study (MRID No.
44285805).
-------------------------------
Non-guideline Non-guideline Thyroid-stimulating
(rat) thyroid hormone levels
function significantly
increased (168-425%)
in high-dose males
and females.
Slightly increased
T3 levels in males
rats above 119.3 mg/
kg/day
Acceptable/
nonguideline
-------------------------------
Metabolite Non-guideline Tolylfluanid's
(mice)In vitro metabolite TTCA was
investigation of shown to reversibly
TTCA goitrogenic inhibit thyroid
properties peroxidase (TPO)-
mediated reactions
involved with the
initial stages of
thyroid hormone
synthesis. This was
shown by the dose-
dependent decrease
in formation of
reactive iodine; the
interference of the
nonenzymatic and TPO-
mediated iodination
of L-tyrosine, and
by TPO-mediated
metabolism of TTCA.
In the latter
reaction, TTCA did
not interfere with
tyrosine iodination
when the
concentration in the
reaction mixture
fell below a certain
concentration.
Therefore, TTCA,
unlike tolylfluanid,
behaves as a
goitrogenic compound
with a potency
approximately equal
to propylthiouracil
(PTU), a known
thionamide inhibitor
of initial thyroid
hormone synthesis.
Acceptable/
nonguideline
-------------------------------
Non-guideline Non-guideline In a \32\P--post-
(rat) labelling assay for
\32\P--post- detection of adduct
labelling assay. formation in lung,
thyroid, and liver
DNA in rats revealed
that there was no
evidence of DNA
adduct formation in
the liver, lung, or
thyroid of rats
exposed to
tolylfluanid.
Positive control 2-
acetylaminofluorene
(2-AAF) (liver,
lung, and thyroid
DNA adducts),
benzidine (lung DNA
adducts), 2-Thiourea
(lung and thyroid
DNA adducts), and
dibenz[a,h]anthracen
e (DBA) (DNA adducts
in the lungs)
produced appropriate
results.
Acceptable/
nonguideline
------------------------------------------------------------------------
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
[[Page 60136]]
variations in sensitivity among members of the human population as well
as other unknowns. An UF of 100 is routinely used, 10X to account for
interspecies differences and 10X for intra species differences.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor (SF)
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 SF.
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. In this case because it is an import tolerance
only, there is only dietary risk.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk is expressed as 1 x 10-\6\ or one in a million).
Under certain specific circumstances, MOE calculations will be used for
the carcinogenic risk assessment. In this non-linear approach, a
``point of departure'' is identified below which carcinogenic effects
are not expected. The point of departure is typically a NOAEL based on
an endpoint related to cancer effects though it may be a different
value derived from the dose-response curve. To estimate risk, a ratio
of the point of departure to exposure (MOEcancer = point of
departure/exposures) is calculated. A summary of the toxicological
endpoints for tolylfluanid used for human risk assessment is shown in
Table 2 of this unit:
Table 2.--Summary of Toxicological Dose and Endpoints for Tolylfluanid 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 NOAEL = 25 1x Prenatal developmental
females 13-50 years of age......... UF\1\ = 300........... toxicity/rabbit
Acute RfD = aPAD = LOAEL = 70 mg/kg/day based
0.083 mg/kg/day. on increased malformations
(arthrogryposis of front
extremities and small
orbital cavity/folded
retina) and variations
(floating ribs and
accelerated ossification).
------------------------------------
Acute dietary NOAEL = 50 1x Acute oral neurotoxicity/
general population including UF\1\ = 300........... rat
infants and children. Acute RfD = aPAD = LOAEL = 150 mg/kg/day based
0.17 mg/kg/day. on FOB effects
(pilorection, decreased
activity, gait
abnormalities, decreased
body temperature, and/or
decreased rearing).
------------------------------------
Chronic dietary NOAEL= 7.9 1x 2-Generation reproduction/
all populations.................... UF\1\ = 300........... rat
Chronic RfD = cPAD = LOAEL = 57.5 mg/kg/day
0.026 mg/kg/day. based on decreased body
weights, body weight
gains, and liver weights.
------------------------------------
Cancer Classification: ``Likely to be carcinogenic to humans'' by the oral route,
based on thyroid tumors in high-dose male and female rats. The FQPA SF
Committee further recommended a linear low-dose extrapolation approach for
the quantification of human cancer risk based on the thyroid tumors in
rats. Q1* = 1.59 x 10-\3\ based upon male rat thyroid adenomas and/or
carcinomas combined.
----------------------------------------------------------------------------------------------------------------
\1\ UF (uncertainty factor), FQPA Safety Factor (SF), no-observed-adverse-effect-level (NOAEL), lowest-observed-
adverse-effect-level (LOAEL), acute Population Adjusted Dose (aPAD), chronic Population Adjusted Dose (cPAD),
reference dose (RfD).
* The reference to the FQPA SF refers to any additional SF retained due to concerns unique to the FQPA.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. This activity reflects
the establishment of the first U.S. import tolerance for tolylfluanid
on apple, grape, hop, and tomato without a U.S. registration. Since
there are no other food or feed uses in the United States, the only
exposure to occur is dietary.
Risk assessments were conducted by EPA to assess dietary exposures
from tolylfluanid in food as follows:
i. Acute exposure. Acute dietary risk assessments are performed for
a food-use pesticide if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a one day
or single exposure. The Dietary Exposure Evaluation Model
(DEEM\TM\7.76) analysis evaluated the individual food consumption as
reported by respondents in the United States Department of Agriculture
(USDA) 1989-1992 nationwide Continuing Surveys of Food Intake by
Individuals (CSFII) and accumulated exposure to the chemical for each
commodity. The following assumptions were made for the acute Tier 2
(partially refined analysis) exposure assessments: An aPAD of 0.083 mg/
kg/day was used for females between 13 and 50 years of age based on
developmental toxicity in rabbits. An aPAD of 0.17 was used for the
general U.S. population (including infants and children) based on acute
neurotoxicity in rats. Anticipated residues were calculated based upon
submitted field trial and livestock metabolism data for all proposed
uses of tolylfluanid.
The resulting acute dietary exposure estimates do not exceed EPA's
level of concern (<100% aPAD) at the 95\th\ exposure percentile for
females 13-50 years old (42% aPAD), the general U.S. population (31% of
the aPAD) and all other population subgroups. The most
[[Page 60137]]
highly exposed population subgroup is infants (<1 year old, at 100% of
the aPAD).
Table 3.--Acute Dietary Exposure to Tolylfluanid
------------------------------------------------------------------------
Acute Dietary\1\
---------------------------------------
Population Subgroup Dietary Exposure
(mg/kg/day) % aPAD
------------------------------------------------------------------------
U.S. Population (total) 0.051973 31
---------------------------------
All Infants 0.169772 100
(< 1 year old)..................
---------------------------------
Children 0.159553 94
1-6 years old...................
---------------------------------
Children 0.063237 37
7-12 years old..................
---------------------------------
Females 0.034529 20
13-50 years old.................
---------------------------------
Males 0.023476 14
13-19 years old.................
---------------------------------
Males 0.030744 18
20+ years old...................
---------------------------------
Seniors 0.033375 20
55+ years old...................
------------------------------------------------------------------------
\1\Acute dietary endpoint of 0.083 mg/kg/day applies to females 13-50
years old only; acute dietary endpoint of 0.17 mg/kg/day applies to
the general U.S. population (including infants and children).
The assessment of acute dietary exposure used the following
conservative assumptions likely to generate upper-end estimates of the
quantity of tolylfluanid and tolylfluanid residues ingested:
[sbull]
No import consumption data were used in the assessment
(i.e., the assessment assumes that all acute dietary exposure from the
proposed commodities is from imported commodities).
[sbull]
100% crop treated (CT) was assumed for these imported
commodities: All imported grape, apple, hop, and tomato were assumed to
have been treated with tolylfluanid and to have tolylfluanid residues
at the level of the tolerance.
Inclusion of additional data, such as %CT/import consumption data
and/or monitoring data (including metabolites of concern), could be
made in order to refine the acute dietary exposure assessment.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment the DEEM\TM\ analysis evaluated the individual food
consumption as reported by respondents in the USDA 1989-1992 nationwide
CSFII and accumulated exposure to the chemical for each commodity. The
following assumptions were made for the chronic exposure assessments:
A cPAD of 0.026 mg/kg/day was used based on the 2-generation rat
reproduction study. All dietary exposure from the proposed commodities
is from imported commodities. Import share data generated within the
Agency were used in the assessment to estimate what proportion of the
grape, apple, hop, and tomato consumed in the United States are
imported. Modified DEEM\TM\ processing factors based on the results of
processing studies were used for raisins and apple and grape juice/
juice concentrates. Default DEEM\TM\ processing factors were used for
all other processed commodities. Anticipated residues calculations were
used based upon submitted field trial and livestock metabolism data.
Table 4.--Chronic Exposure to Tolylfluanid
------------------------------------------------------------------------
Chronic Dietary\1\
---------------------------------------
Population Subgroup Dietary Exposure
(mg/kg/day) % aPAD
------------------------------------------------------------------------
U.S. Population (total) 0.000780 3
---------------------------------
All Infants 0.003397 13
(< 1 year old)..................
---------------------------------
Children 0.003638 14
1-6 years old...................
---------------------------------
Children 0.001029 4
7-12 years old..................
---------------------------------
Females 0.000399 2
13-50 years old.................
---------------------------------
Males 0.000342 1
13-19 years old.................
---------------------------------
Males 0.000340 1
20+ years old...................
---------------------------------
Seniors 0.000333 1
55+ years old...................
------------------------------------------------------------------------
\1\Chronic dietary endpoint of 0.026 mg/kg/day applies to general U.S.
population and all population subgroups.
The assessment of chronic dietary exposure for the general U.S.
population and all population subgroups (including infants and
children) used the following conservative assumptions to generate
upper-end estimates of the quantity of tolylfluanid and tolylfluanid
residues ingested:
100% CT was assumed for these imported commodities: All
imported grape, apple, hop, and tomato were assumed to have been
treated with tolylfluanid and to have tolylfluanid residues at the
level of the tolerance.
The calculated ARs (parent and additional metabolites of
concern not in tolerance expression) are based on field trial data,
submitted by the registrant to support tolerances. Field trial residue
data are generally considered by the Agency as an upper-end or a worst
case scenario of possible residues and are more suited to the
requirements of tolerance setting, because it requires highest rates of
application and shortest PHI, than to the requirements of dietary
exposure assessment (when a more realistic estimate is desired).
The chronic dietary exposure estimates do not exceed EPA's level of
concern (<100% cPAD) for the general U.S. population (3% cPAD) and all
population subgroups. The most highly exposed population subgroup is
children 1-6 years old at 14% of the cPAD.
iii. Cancer. A partially refined, cancer dietary exposure
assessment was conducted for the general U.S. population using the same
assumptions as were used in the chronic risk assessment (listed in the
preceding section). Import share data generated within the Agency were
used in the assessment to estimate what proportion of the grape, apple,
hop, and tomato consumed in the United States are imported. Modified
DEEM\TM\ processing factors based on the results of processing studies
were used for raisins and apple and grape juice/juice concentrates.
Default DEEM\TM\ processing factors were used for all other processed
commodities The cancer risk estimate is 1.2 x 10-\6\ for the
general U.S. population.
For cancer dietary risk estimates, the Agency is generally
concerned with cancer risks that exceed the range of 1 x
10-\6\. The following conservative assumptions were used in
the cancer dietary exposure assessment:
The percent import consumption information used for apple,
grape and tomato commodities assume that 100% of these imported
commodities are treated with tolylfluanid.
The calculated ARs are based on field trial data, submitted
by the registrant to support tolerances. Field trial residue data are
generally considered by the Agency as providing an upper-end scenario
of possible residues and are more suited to the requirements of
tolerance setting, because it requires highest rates of application and
shortest PHI, than to the requirements of dietary exposure
[[Page 60138]]
assessment (when a more realistic estimate is desired).
With additional refinements to the dietary exposure assessment
(i.e., country-specific percent import consumption data and/or
monitoring data (including metabolites of concern) the Agency expects
the estimated cancer risk to be significantly lower.
iv. Anticipated residue and %CT.
Section 408(b)(2)(E) of the FFDCA authorizes EPA to use available
data and information on the anticipated residue levels of pesticide
residues in food and the actual levels of pesticide chemicals that have
been measured in food. Adequate reliable information was not available
on the fraction of imported grape, apple, hop, and tomato which were
treated with tolylfluanid, therefore the Agency assumed that all these
commodities were treated (100% CT). In addition, the Agency must
provide for periodic evaluation of any estimates used. As required by
section 408(b)(2)(E) of the FFDCA, EPA will issue a data call-in for
information relating to anticipated residues to be submitted no later
than 5 years from the date of issuance of this tolerance.
Section 408(b)(2)(F) of the FFDCA states that the Agency may use
data on the actual percent of food treated for assessing chronic
dietary risk only if the Agency can make the following findings:
Condition 1, that the data used are reliable and provide a valid basis
to show what percentage of the food derived from such crop is likely to
contain such pesticide residue; Condition 2, that the exposure estimate
does not underestimate exposure for any significant subpopulation
group; and Condition 3, if data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area. In addition, the
Agency must provide for periodic evaluation of any estimates used. To
provide for the periodic evaluation of the estimate of %CT as required
by section 408(b)(2)(F) of the FFDCA, EPA may require registrants to
submit data on %CT. The Agency used %CT information as follows:
Since the tolerances being established are for imported commodities
only and a petition for domestic use of tolyfluanid is not currently
pending with EPA, the Agency analyzed the amount of imported apple,
grape, hop, and tomato, relative to domestic production, and derived a
``percent crop imported'' figure for each commodity. The Agency based
this analysis on import and domestic production data available from the
USDA for the years 1995 through 1999. The proportion of imports
relative to domestic production for each of the commodities are as
follows: Fresh apple--5.6%; apple juice--56.4%; canned apple--0.1%;
fresh grape--0.2%, grape juice--43.4%; fresh tomato--16.4%; and
processed tomato--4.1%. The Agency's analysis assumed 100% for hop.
Tolylfluanid is currently only registered for use in a small number of
European countries, however, the estimates stated in this unit reflect
total imports of these commodities into the United States, not just
imports from Europe. Therefore, the values used in the Agency's risk
assessment assume that all imported commodities contain residues of
tolyfluanid. These assumptions fulfill Condition 1 by overestimating
the portion of imported apple, grape, hop, and tomato with tolylfluanid
residues. As to Conditions 2 and 3, regional consumption information
and consumption information for significant subpopulations is taken
into account through EPA's computer-based model for evaluating the
exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency.
2. Dietary exposure from drinking water. Residues in drinking water
are not expected to result as a consequence of establishing an import
tolerance for tolylfluanid residues in or on apple, grape, hop, and
tomato. Tolylfluanid is not registered for use in the United States.
Therefore, exposure through drinking water is unlikely.
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). Tolylfluanid is not
registered for use on any sites that would result in residential
exposure.
4. Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA does not have, at this time, available data to determine
whether tolylfluanid 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,
tolylfluanid 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 tolylfluanid 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. Section 408 of the FFDCA provides that EPA shall
apply an additional 10-fold 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 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. There is no quantitative or
qualitative evidence of increased susceptibility following in utero
exposure in the prenatal developmental study in rats. Although there is
qualitative evidence of increased susceptibility in the prenatal
developmental study in rabbits and in the 2-generation reproduction
study in rats, the Agency did not identify any residual uncertainties
after establishing toxicity endpoints and traditional UFs to be used in
the risk assessment of tolylfluanid.
3. Conclusion. There is a complete toxicity data base for
tolylfluanid and exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures. The RfDs
established are protective of pre-/post-natal toxicity following acute
and chronic exposures. The Agency therefore concluded that no Special
FQPA FS is necessary to protect the safety of infants and children in
assessing tolylfluanid exposure and
[[Page 60139]]
risks. However, a FQPA factor in the form of data base UF
(UFDB) of 3x was applied to the acute RfDs and chronic RfDs
to account for the comparative thyroid assay (adult versus young
animals) data requirement. 3X is adequate in this case since the
observed thyroid hormone changes that necessitated the additional study
occurred at a dose level more than three-fold higher than the dose
levels (based on developmental and reproductive toxicity) used as the
basis for endpoints for risk assessment. Thus, use of an additional 3X
FQPA SF will provide at least a 10X margin of safety regarding the
effects for which there is some uncertainty and for which additional
data is required.
Table 5.--Additional FQPA Safety Factor
----------------------------------------------------------------------------------------------------------------
Special FQPA
LOAEL to NOAEL Subchronic to Incomplete Data Safety Factor
(UFL) Chronic (UFS) base (UFDB) (Hazard and
Exposure)
----------------------------------------------------------------------------------------------------------------
Magnitude of factor 1X 1X 3X 1X
---------------------------------
Rationale for the factor No LOAEL to NOAEL No subchronic to Lack of No residual
extrapolations chronic comparative uncertainties
performed extrapolations thyroid assay regarding pre- or
performed (adult versus post-natal
young animals). toxicity or
completeness of
the toxicity or
exposure data
bases
---------------------------------
Endpoints to which the factor is Not applicable NA All dietary NA
applied (NA) exposure
scenarios
----------------------------------------------------------------------------------------------------------------
E. Aggregate Risks and Determination of Safety
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food to
tolylfluanid will occupy 31% of the aPAD for the U.S. population, 20%
of the aPAD for females 13 years and older, 100% of the aPAD for
infants < 1year old, and 94% of the aPAD for children between 7 and 12
years old. In addition, there is no potential for acute dietary
exposure to tolylfluanid in drinking water. Although this risk
assessment projects that infants under 1 year of age will receive the
maximum safe exposure, for the reasons detailed in this unit, this
assessment is likely to substantially overstate risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
tolylfluanid from food will utilize 3% of the cPAD for the U.S.
population, 13% of the cPAD for infants < 1 year old, and 14% of the
cPAD for children between 1 and 6 years old. There are no residential
uses for tolylfluanid that result in chronic residential exposure to
tolylfluanid.
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). Tolylfluanid is not
registered for use on any sites that would result in residential
exposure. Therefore, a short-term aggregate risk was not performed.
4. Intermediate-term risk. Tolylfluanid is not registered for use
on any sites that would result in residential exposure. Therefore, an
intermediate-term aggregate risk was not performed.
5. Aggregate cancer risk for U.S. population. The cancer risk
estimate for the general U.S. population from tolylfluanid is 1.2 x
10-\6\. In general, the Agency's level of concern for cancer
exposure is for risks in the range of 1 x 10-\6\ and this
risk estimate is comfortably with this range. Moreover, several
conservative assumptions were included in the assessment (enumerated in
Unit III.C.1., Dietary exposure from food and feed uses). With
additional refinements to the dietary exposure assessment (i.e.,
country-specific percent import consumption data and/or monitoring data
(including metabolites of concern), the Agency expects the cancer risk
to be substantially lower.
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 tolylfluanid residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
For tolylfluanid in/on apple, grape, hop, and tomato, the submitted
independent laboratory validation (ILV) using a gas chromatograph (GC)/
thermal ionization detector (TID) procedure designated as Method 00441
and entitled Determination of Tolylfluanid in/on Various Raw
Agricultural and Processed Commodities has been received and the method
has been forwarded to the Agency's laboratory for validation. The
petitioner will be required to make any modifications or revisions to
the proposed method resulting from EPA's validation.
The petitioners submitted the multiresidue data concerning the
recovery of tolylfluanid residues using the Food and Drug
Administration (FDA) MRM protocols (PAM Vol. I) and following modified
cleanup procedures. These results indicate that tolylfluanid is likely
to be recovered through FDA MRM Protocols D and E. The results have
been forwarded to the FDA for inclusion in the Pesticide Analytical
Method Volume I.
Prior to publication and upon request, the method will be available
from the Analytical Chemistry Branch (ACB), BEAD (75053), Environmental
Science Center, 701 Mapes Rd., Ft. George C. Meade, MD 20755-5350.
Contact Francis D. Griffith, Jr., telephone number: (410) 305-2905; e-
mail address: griffith.francis@epa.gov. The analytical standards are
also available from the EPA National Standard Repository at the same
location.
Based on the proposed uses, a residue enforcement method for
livestock commodities is not necessary at this time.
B. International Residue Limits
There are no Canadian or Mexican MRLs established for tolylfluanid
residues in/on crop commodities. The Codex Alimentarius Commission has
established MRLs for tolylfluanid residues in/on various commodities,
including currant at 5 ppm, gherkin at 2 ppm, lettuce head at 1 ppm,
pome
[[Page 60140]]
fruits at 5 ppm, strawberry at 3 ppm, and tomato at 2 ppm. The Codex
MRLs are expressed in terms of tolylfluanid per se. Although the
submitted residue data support the proposed tolerance of 1.0 ppm on
tomato, the Agency is establishing this tolerance at 2.0 ppm in order
to harmonize with the current Codex MRL.
V. Conclusion
Therefore, the tolerance is established for residues of
tolylfluanid, (1,1-dichloro-N-[(dimethylamino)-sulfonyl]-1-fluoro-N-(4-
methylphenyl)methanesulfenamide), in or on apple at 5 ppm, grape at 11
ppm, hop at 30 ppm, and tomato at 2 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, EPA will continue to use those procedures, with
appropriate adjustments, until the necessary modifications can be made.
The new section 408(g) of the FFDCA provides essentially the same
process for persons to ``object'' to a regulation for an exemption from
the requirement of a tolerance issued by EPA under new section 408(d)
of the FFDCA, as was provided in the old sections 408 and 409 of the
FFDCA. However, the period for filing objections is now 60 days, rather
than 30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number OPP-2002-0216 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 November
25, 2002.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900C),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Rm.104, Crystal Mall i
2, 1921
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Office of the Hearing Clerk is
(703) 603-0061.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.2. Mail your
copies, identified by docket ID number OPP-2002-0216, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the
PIRIB described in Unit I.B.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 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 section 408(d) of the
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any
[[Page 60141]]
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review
or any Agency action under Executive Order 13045, entitled Protection
of Children from Environmental Health Risks and Safety Risks (62 FR
19885, April 23, 1997). This action does not involve any technical
standards that would require Agency consideration of voluntary
consensus standards pursuant to section 12(d) of the National
Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law
104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and
exemptions that are established on the basis of a petition under
section 408(d) of the FFDCA, such as the tolerance in this final rule,
do not require the issuance of a proposed rule, the requirements of the
Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply.
In addition, the Agency has determined that this action will not have a
substantial direct effect on States, on the relationship between the
national government and the States, or on the distribution of power and
responsibilities among the various levels of government, as specified
in Executive Order 13132, entitled Federalism (64 FR 43255, August 10,
1999). Executive Order 13132 requires EPA to develop an accountable
process to ensure ``meaningful and timely input by State and local
officials in the development of regulatory policies that have
federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers, and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of the FFDCA. For these same reasons, the Agency
has determined that this rule does not have any ``tribal implications''
as described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (59 FR 22951, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.
VIII. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: September 13, 2002.
James Jones,
Acting Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), 346(a) and 371.
2. Section 180.584 is added to subpart C to read as follows:
Sec. 180.584 Tolylfluanid, tolerances for residues.
(a) General. Tolerances are established for residues of
tolylfluanid, 1,1-dichloro-N-[(dimethylamino)-sulfonyl]-1-fluoro-N-(4-
methylphenyl)methanesulfenamide in or on the following commodities.
----------------------------------------------------------------------------------------------------------------
Commodity Parts per million
----------------------------------------------------------------------------------------------------------------
Apple\1\............................................. 5.0
Grape\1\.............................................. 11
Hop\1\................................................ 30
Tomato\1\............................................. 2.0
----------------------------------------------------------------------------------------------------------------
\1\ No U.S. registration as of August 31, 2002.
[[Page 60142]]
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 02-24094 Filed 9-24-02; 8:45 am]
BILLING CODE 6560-50-S