Flufenacet (Bayer). June 25, 2003. Pesticide tolerances. Final Rule. Federal Register.

FLUORIDE ACTION NETWORK PESTICIDE PROJECT

Flufenacet (Bayer). June 25, 2003. Pesticide Tolerances. Final Rule. Federal Register.

http://www.epa.gov/fedrgstr/EPA-PEST/2003/June/Day-25/p15905.htm

[Federal Register: June 25, 2003 (Volume 68, Number 122)]
[Rules and Regulations]
[Page 37749-37759]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25jn03-13]

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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2003-0181; FRL-7313-9]

Flufenacet (N-(4-fluorophenyl)-N-(1-methylethyl)-2-[[5-
(trifluoromethyl)-1,3,4-thiadiazol-2-yl]oxy]acetamide; Pesticide
Tolerance

AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.

-----------------------------------------------------------------------
SUMMARY:

This regulation establishes a tolerance for combined residues of
flufenacet (N-(4-fluorophenyl)-N-(1-methylethyl)-2-[[5-
(trifluoromethyl)-1,3,4-thiadiazol-2-yl]oxy]acetamide and its
metabolites containing the 4-fluoro-N-methylethyl benzenamine moiety in
or on corn, field, forage; corn, field, grain; corn, field, stover; and
soybean, seed; and for indirect or inadvertent residues for flufenacet
and its metabolites in or on alfalfa, forage; alfalfa, hay; alfalfa,
seed; clover, forage; clover, hay; grain, cereal, group 15, except
rice; grain, cereal, forage, fodder and straw, group 16, except rice;
and grass, forage, fodder, and hay, group 17. BayerCropScience
requested this tolerance under the Federal Food, Drug, and Cosmetic Act
(FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective June 25, 2003. Objections and
requests for hearings, identified by docket ID number OPP-2003-0181,
must be received on or before August 25, 2003.

ADDRESSES: Written objections and hearing requests may be submitted
electronically, by mail, or through hand delivery/courier. Follow the
detailed instructions as provided in Unit VII. of the SUPPLEMENTARY
INFORMATION.

FOR FURTHER INFORMATION CONTACT: James A. Tompkins, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460-
0001; telephone number: (703) 305-5697; e-mail address:
tompkins.jim@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

B. How Can I Get Copies of this Document and Other Related Information?

1. Docket. EPA has established an official public docket for this
action under docket identification (ID) number OPP-2003-0181. The
official public

[[Page 37750]]

docket consists of the documents specifically referenced in this
action, any public comments received, and other information related to
this action. Although a part of the official docket, the public docket
does not include Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. The official
public docket is the collection of materials that is available for
public viewing at the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The docket telephone
number is (703) 305-5805.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the`` Federal Register''
listings at http://www.epa.gov/fedrgstr/. A frequently updated
electronic version of 40 CFR part 180 is available 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.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in the system, select ``search,'' then key in the
appropriate docket ID number.

II. Background and Statutory Findings

In the Federal Register of March 20, 2003 (68 FR 13703) (FRL-7296-
5), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C.
346a, as amended by FQPA (Public Law 104-170), announcing the filing of
pesticide petitions (PP 6F4631 and 0F6095) by BayerCropScience, P.O.
Box 12014, 2 T. W. Alexander Drive, Research Triangle Park, NC 27709.
That notice included a summary of the petitions prepared by
BayerCropScience, the registrant. One comment was received in response
to this notice of filing by B. Sachau, 15 Elm Str., Florham Park, NJ
07932. Mr. Sachau objected generally to the presence of pesticides in
food and specifically to the presence of flufenacet.
Bayer requested in petition 6F4631 that 40 CFR 180.527 (a) be
amended by making the currently time-limited tolerances for combined
residues of the herbicide flufenacet, N-(4-fluorophenyl)-N-(1-
methylethyl)-2-[[5-(trifluoromethyl)-1,3,4-thiadiazol-2-
yl]oxy]acetamide and its metabolites containing the 4-fluoro-N-
methylethyl benzenamine moiety]
permanent in or on the following
agricultural commodities: Corn, field, forage at 0.4 ppm; corn, field,
grain at 0.05 ppm; corn, field, stover at 0.4 ppm; and soybean, seed at
0.1 ppm.
Bayer requested in petition 0F6095 that the section 18 tolerances
listed below in 40 CFR 180.527 (b) for combined residues of the
herbicide flufenacet, N-(4-fluorophenyl)-N-(1-methylethyl)-2-[[5-
(trifluoromethyl)-1,3,4-thiadiazol-2-yl]oxy]acetamide and it's
metabolites containing 4-fluoro-N-methylethyl benzenamine moiety]
be
made permanent and moved to 40 CFR 180.527 (a), cattle, fat at 0.05
ppm; cattle, kidney at 0.5 ppm; cattle, meat at 0.05 ppm; cattle, meat
byproducts at 0.1 ppm; goat, fat at 0.05 ppm; goat, kidney at 0.5 ppm;
goat, meat at 0.05 ppm; goat, meat byproducts at 0.1 ppm; hog, fat at
0.05 ppm; hog, kidney at 0.5 ppm; hog, meat at 0.05 ppm; hog, meat,
byproducts at 0.1 ppm; horse, fat at 0.05 ppm; horse, kidney at 0.5
ppm; horse, meat at 0.05 ppm; horse, meat byproducts at 0.1 ppm; sheep,
fat at 0.05 ppm; sheep, kidney at 0.5 ppm; sheep, meat at 0.05 ppm;
sheep, meat byproducts at 0.1 ppm; wheat, forage at 10.0 ppm; wheat,
grain at 1.0 ppm; wheat, hay at 2.0 ppm; and wheat, straw at 0.50 ppm.
Bayer requested in petition 0F6095 that the currently time limited
tolerances in 40 CFR 180.527 (d) be amended by establishing permanent
tolerances for indirect or inadvertent residues of the herbicide
flufenacet;N-(4-fluorophenyl)-N-(1-methylethyl)-2- [[5-
(trifluoromethyl)-1,3,4- thiadiazol-2-yl]oxy]acetamide and its
metabolites containing the 4-fluoro-N-methylethyl benzenamine moiety in
or on the following raw agricultural commodities from the application
of this herbicide to the raw agricultural commodities listed in 40 CFR
180.527 (a) and (b) at the levels listed below Table 1:

Table 1.--Tolerance Levels
------------------------------------------------------------------------
Level in Parts per
Commodity Current level in Million proposed
Parts per Million by Bayer
------------------------------------------------------------------------
Alfalfa, forage 0.1 0.1
------------------------------------------------------------------------
Alfalfa, hay 0.1 0.1
------------------------------------------------------------------------
Alfalfa, seed 0.1 0.1
------------------------------------------------------------------------
Clover, forage 0.1 0.1
------------------------------------------------------------------------
Clover, hay 0.1 0.1
------------------------------------------------------------------------
Grain, cereal, group 15, except 0.1 0.4
rice
------------------------------------------------------------------------
Grain, cereal, forage, fodder, 0.1 10.0
and straw, group 16, except
rice
------------------------------------------------------------------------
Grass, forage, fodder and hay, 0.1 0.1
group 17
------------------------------------------------------------------------

The Agency's current review did not include the data submitted with
petition 0F6095. Therefore, the Agency is leaving the section 18 time
limited tolerances listed in 40 CFR 180.527 (b) unchanged. The time
limited tolerances listed in 40 CFR 180.527 (b) were issued in
connection with a section 18 and were extended to July, 2005 on January
16, 2003 (68 FR 2242)(FRL-7284-8). The section 18 tolerances are not
being modified in this notice but are included in the risk assessments
discussed below. In addition, since the Agency's current review did not
include the data submitted with petition 0F6095 and the risk assessment
outlined below indicated that the risk cup was full, the tolerances for
indirect or inadvertent residues listed in 40 CFR 180.527(d) will be
made permanent but the levels will remain unchanged.
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 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

[[Page 37751]]

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 tolerances for combined residues of
flufenacet, ( N-(4-fluorophenyl)-N-(1-methylethyl)-2-[[5-
(trifluoromethyl)-1,3,4-thiadiazol-2-yl]oxy]acetamide) and its
metabolites containing the 4-fluoro-N-methylethyl benzenamine moiety on
corn, field, forage at 0.4 ppm; corn, field, grain at 0.05 ppm; corn,
field, stover at 0.4 ppm; soybean, seed at 0.1 ppm by establishing
permanent tolerances for indirect or inadvertent residues of the
herbicide flufenacet, (N-(4-fluorophenyl)-N-(1-methylethyl)-2-[[5-
(trifluoromethyl)-1,3,4- thiadiazol-2-yl]oxy]acetamide) and metabolites
containing the 4-fluoro-N-methylethyl benzenamine moiety in or on the
following raw agricultural commodities from the application of this
herbicide to the raw agricultural commodities, listed in 40 CFR 180.527
(a) and (b), alfalfa, forage at 0.1 ppm; alfalfa, hay at 0.1 ppm;
alfalfa, seed at 0.1 ppm; clover, forage at 0.1 ppm; clover, hay at 0.1
ppm; grain, cereal, group 15, except rice at 0.1 ppm; grain, cereal,
forage, fodder, and straw, group 16, except rice at 0.1 ppm; and grass,
forage, fodder, and hay, group 17 at 0.1 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 flufenacet are
discussed in Table 2 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 2.--Subchronic, Chronic, and Other Toxicity
----------------------------------------------------------------------------------------------------------------
Guideline No. Study Type Results
----------------------------------------------------------------------------------------------------------------
870.3100 90-Day oral toxicity NOAEL = <6.0 (male [m], 7.2 (female [f])
rodents - rat milligram/kilogram/day (mg/kg/day)
LOAEL = 6.0(m) mg/kg/day based on decreased
T4; 28.8 mg/kg/day (f) and on hematology
and clinical chemistry findings
----------------------------------------------------------------------------------------------------------------
870.3100 90-day feeding - mouse NOAEL(mg/kg/day)=18.2(m),24.5(f),
LOAEL (mg/kg/day)=64.2 (m), 91.3(f) based
on systemic toxicity and histopathology of
the liver, spleen, and thyroid.
----------------------------------------------------------------------------------------------------------------
870.3150 90-Day oral toxicity in NOAEL (mg/kg/day)= 1.67 (m);1.70 (f).
nonrodents LOAEL (mg/kg/day)= 7.20 (m); 6.90 (f) based
on increases in LDH, globulin, and spleen
pigment in females, decreased T4 and ALT
values in both sexes, decreased albumin in
males, and decreased serum glucose in
females
----------------------------------------------------------------------------------------------------------------
870.3200 21/28-Day dermal toxicity Dermal irritation
NOAEL(mg/kg/day)=1000 (m and f) Systemic
toxicity
NOAEL mg/kg/day) = 20(m); 150(f)
LOAEL(mg/kg/day)= 150(m);1,000(f) based on
decreased T4 and FT4 levels in both sexes
and histopathological findings in females
----------------------------------------------------------------------------------------------------------------
870.3700 Prenatal developmental Maternal NOAEL = 25 mg/kg/day
toxicity in rodents (rat) LOAEL = 125 mg/kg/day based on decreased
BWG initially
Developmental NOAEL = 25 mg/kg/day
LOAEL = 125 mg/kg/day based on decreased
fetal body weight, delayed ossificaition
in skull, vertebrae, sternebrae, and
appendages, and increased extra ribs.
----------------------------------------------------------------------------------------------------------------
870.3700 Prenatal developmental Maternal NOAEL = 5 mg/kg/day
toxicity in nonrodents LOAEL = 25 mg/kg/day based on
(rabbits) histopathological findings in liver.
Developmental NOAEL = 25 mg/kg/day
LOAEL = 125 mg/kg/day based on increased
skeletal variations.
----------------------------------------------------------------------------------------------------------------
870.3800 Reproduction and fertility Parental/Systemic NOAEL = 1.4 (m), 1.5(f)
effects - rat mg/kg/day
LOAEL = 7.4 (m), (8.2 (f) mg/kg/day based
on increased liver weight in F1 females
and hepatocytomegaly in F1 males
Reproductive NOAEL = 1.3 mg/kg/day
LOAEL = 6.9 mg/kg/day based on increased
pup death in early lactation (including
cannibalism) for F1 liters and the same
effects in F1 and F2 pups at 36 mg/kg/day.
----------------------------------------------------------------------------------------------------------------

[[Page 37752]]

870.4100 Chronic toxicity dogs NOAEL = 1.29(m), 1.14(f) mg/kg/day
LOAEL = 27.75 (m), 26.82(f) mg/kg/day based
on increased alkaline phosphatase, kidney,
and liver weight in both sexes, increased
cholesterol in males, decreased T3, T4,
and ALT values in both sexes, and
increased incidences of microscopic
lesions in the brain, eye, kidney, spinal
cord, sciatic nerve, and liver.
----------------------------------------------------------------------------------------------------------------
870.4300 Chronic toxicity/ NOAEL =1.2 (m), 1.5 (f) mg/kg/day
oncogenicity in rodents LOAEL = 19.3 (m), 24.4(f) mg/kg/day based
(rat) on methemoglobinemia and multi-organ
effects in blood, kidney, spleen, heart,
brain, eye, liver and uterus.
No evidence of carcinogenicity
----------------------------------------------------------------------------------------------------------------
870.4300 Carcinogenicity mice NOAEL = <7.4 ((m), 9.4 (f) mg/kg/day
LOAEL = 7.4 (m), 38.4 (f) mg/kg/day based
on increased incidence and severity of
cataracts.
No evidence of carcinogenicity
----------------------------------------------------------------------------------------------------------------
870.5100 Gene Mutation Ames Assay S. typhimurium not mutagenic
870.5395 Cytogenetics In vivo mammalian cytogenetics--
micronucleus assay (mouse) not mutagenic.
870.5375 In vitro mammalian cytogenetics- Chinese
hamster lung fibroblasts (V79) cells not
mutagenic.
870.5375 In vitro cytogenetics chromosomal analysis
of cultured CHO cells-not mutagenic.
870.5550 Other Effects Unscheduled DNA synthesis in rat
hepatocytes in vitro-not mutagenic.
----------------------------------------------------------------------------------------------------------------
870.6200 Acute neurotoxicity NOAEL = <75 (m and f) mg/kg/day
screening battery LOAEL = 75 (m and f) mg/kg/day based on
clinical signs in females (uncoordinated
gait and decreased activity) and decreased
motor activity in males.
----------------------------------------------------------------------------------------------------------------
870.6200 Subchronic neurotoxicity NOAEL = 7.30 (m), 8.40 (f) mg/kg/day
screening battery LOAEL = 38.1 (m), 42.6 (f) mg/kg/day based
on microscopic lesions (including axonal
swelling in brain and spinal cord).
----------------------------------------------------------------------------------------------------------------
870.6300 Developmental Maternal NOAEL = 40.8 mg/kg/day
neurotoxicity LOAEL = not determined (no adverse effects
seen). Offspring NOAEL = <1.7 mg/kg/day
LOAEL = 1.7 mg/kg/day based on decreased
pre- weaning body weight and body weight
gain.
----------------------------------------------------------------------------------------------------------------
870.7485 Metabolism and Rapidly absorbed and metabolized following
pharmacokinetics oral exposure to either single or multiple
doses. The urine was the major route of
excretion with small amount excreted via
feces. Significant amounts of radiolabel
were eliminated as CO₂ and CH₄. A maximum
of 7% of the total recovered radiolabel
was found in the tissues and residual
carcass. Twenty-five metabolites arising
from the fluorophenyl portion of the
molecule were detected in excreta, and 17
of these were identified. The total amount
of radiolabel identified ranged from
[Fluorophenyl-UL-\14\C]
FOE 5043 67%-86%;
[Thiadiazole-2-\14\C]
FOE 5043 84%-92%;
and [Thiadiazole-5-\14\C]
FOE 5043 53%-
69%. All unidentified residues in excreta
were characterized .
----------------------------------------------------------------------------------------------------------------
n/a Metabolism/Mechanism Hypothesis of an extrathyroidal mechanism
of action for FOE 5043 (flufenacet)
Hypothesis of an extrathyroidal mechanism
of action for FOE 5043-supplement to
above.
----------------------------------------------------------------------------------------------------------------
n/a Metabolism/Metabolite Evaluated a hypothesis that the
neurotoxicity observed in dogs dosed with
high levels of FOE 5043 was caused by
metabolic limitations.
----------------------------------------------------------------------------------------------------------------

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.
The Agency imposed an additional 10X safety factor to account for
uncertainties arising because available data support the possibility of
decreases in thyroid hormones at dose levels similar to those used in
the submitted rat developmental neurotoxicity study (DNT) as well as
the lack of a NOAEL in the rat developmental neurotoxicity study. To
address these concerns the Agency will require a special comparative
assay on thyroid hormone levels in neonatal and adult rats as a
condition of registration. The Agency also had a concern for a lack of
a NOAEL in the rat developmental neurotoxicity study and for the
decrease in morphometric measurements in adult females which were not
measured at the lowest dose. The doses and endpoints for various risk
assessments and the uncertainty factors applied are expected to
adequately address uncertainties

[[Page 37753]]

arising from the missing data and a lack of a NOEL in the DNT study.
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
flufenacet, the Agency concluded that the Special FQPA Safety Factor
could be reduced to 1X, based on the low degree of concern and lack of
residual uncertainties for pre- and post-natal toxicity as outlined in
Unit III.D.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the LOC. For example, when 100 is the appropriate UF (10X
to account for interspecies differences and 10X for intraspecies
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and
compared to the LOC.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk is expressed as 1 x 10-\6\ or one in a million).
Under certain specific circumstances, MOE calculations will be used for
the carcinogenicity risk assessment. In this non-linear approach, a
``point of departure'' is identified below which carcinogenic effects
are not expected. The point of departure is typically a NOAEL based on
an endpoint related to cancer effects though it may be a different
value derived from the dose response curve. To estimate risk, a ratio
of the point of departure to exposure (MOE_cancer = point of
departure/exposures) is calculated.
A summary of the toxicological endpoints for flufenacet used for
human risk assessment is shown in Table 3 of this unit:

Table 3.--Summary of Toxicological Dose and Endpoints for Flufenacet for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
Special FQPA SF* and
Exposure Scenario Dose Used in Risk Level of Concern for Study and Toxicological
Assessment, UF Risk Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (General population LOAEL = 1.7 mg/kg/day FQPA SF = 1X Developmental
including infants and children) UF = 1,000X............ aPAD = acute RfD/FQPA Neurotoxicity study in
Acute RfD =............ SF. rats.
LOAEL/UF = 0.0017 mg/kg/ = 0.0017 mg/kg/day..... LOAEL = 1.7 mg/kg/day
day. based on decreased
body weight/body
weight gain, and
missing morphometric
measurements in
caudate/putamen, in
pups.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary (All populations) LOAEL= 1.7 mg/kg/day FQPA SF = 1X Developmental
UF = 1,000............. cPAD = chronic RfD/ Neurotoxicity study in
Chronic RfD =.......... FQPA SF. rats.
LOAEL/UF = 0.0017 mg/kg/ = 0.0017 mg/kg/day..... LOAEL = 1.7 mg/kg/day
day. based on decreased
body weight/body
weight gain in pups.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) Classifed as 'Not Likely' to be a carcinogen.
----------------------------------------------------------------------------------------------------------------
UF = uncertainty factor, FQPA SF = Special FQPA safety factor, NOAEL = no-observed-adverse-effect- level, LOAEL
= lowest-observed-adverse-effect-level, PAD = population-adjusted dose (a = acute, c = chronic) RfD =
reference dose, MOE = margin of exposure, LOC = level of concern, NA = Not Applicable/Not Required.
* 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. Tolerances have been
established (40 CFR 180.527) for the combined residues of flufenacet,
N-(4-fluorophenyl)-N-(1-methylethyl)-2-[[5-(trifluoromethyl)-1,3,4-
thiadiazol-2-yl]oxy]acetamide]
and its metabolites containing the 4-
fluoro-N-methylethyl benzenamine moiety, in or on a variety of raw
agricultural commodities. Tolerances have been established on meat,
fat, kidney, and meat byproducts of cattle, goats, hogs, horses, and
sheep, wheat grain, forage, hay, and straw in connection with a section
18. These tolerances expire July, 2005 and have been included in the
risk assessments. Risk assessments were conducted by EPA to assess
dietary exposures from flufenacet in food as follows:
i. Acute exposure. Acute dietary risk assessments are performed for
a food-use pesticide if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a one day
or single exposure. The Dietary Exposure Evaluation Model (DEEM\ \)
analysis evaluated the individual food consumption as reported by
respondents in the USDA [1994-1996 and 1998]
nationwide Continuing
Surveys of Food Intake by Individuals (CSFII) and accumulated expoure
to the chemical for each commodity. The following assumptions were made
for the acute exposure assessments:
a. Anticipated-residue estimates were assumed for some commodities
(field corn, soybeans, and wheat);
b. Tolerance-level residues were assumed for some crops (cereal
grains); and
c. Percent crop-treated estimates were utilized for all crops.
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 [- 1994--1996 and 1998]
nationwide Continuing Surveys of Food
Intake by Individuals (CSFII) and accumulated exposure to the chemical
for each commodity. The following assumptions were made for the chronic
exposure assessments:
a. Anticipated-residue estimates were assumed for some commodities
(field corn, soybeans, and wheat);
b. Tolerance-level residues were assumed for some crops (cereal
grains); and
c. Percent crop-treated estimates were utilized for all crops.
iii. Cancer. Flufenacet is not carcinogenic, therefore a
quantitative cancer risk assessment was not performed.

[[Page 37754]]

iv. Anticipated residue and percent crop treated (PCT) information.
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. If EPA relies on such information, EPA must require
that data be provided 5 years after the tolerance is established,
modified, or left in effect, demonstrating that the levels in food are
not above the levels anticipated. Following the initial data
submission, EPA is authorized to require similar data on a time frame
it deems appropriate. 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 PCT as required
by section 408(b)(2)(F) of the FFDCA, EPA may require registrants to
submit data on PCT.
The Agency used PCT information as follows.
Based on current use, the Agency used the following percent crop
treated estimates: Field corn 2%, soybeans1%, and wheat 1%,. For crops
planted in rotation (cereal grains), 2% crop treated was assumed as
this is the highest estimate for the primary crops. For livestock
commodities, a percent crop treated estimate of 1%, corresponding to
the use on wheat, was utilized. The Agency has previously concluded
that secondary residues of flufenacet in livestock commodities would
not result from the use of flufenacet on corn or soybeans but would
result from the section 18 use on wheat.
The Agency believes that the three conditions listed above have
been met. With respect to Condition 1, PCT estimates are derived from
Federal and private market survey data, which are reliable and have a
valid basis. EPA uses a weighted average PCT for chronic dietary
exposure estimates. This weighted average PCT figure is derived by
averaging State-level data for a period of up to 10 years, and
weighting for the more robust and recent data. A weighted average of
the PCT reasonably represents a person's dietary exposure over a
lifetime, and is unlikely to underestimate exposure to an individual
because of the fact that pesticide use patterns (both regionally and
nationally) tend to change continuously over time, such that an
individual is unlikely to be exposed to more than the average PCT over
a lifetime. For acute dietary exposure estimates, EPA uses an estimated
maximum PCT. The exposure estimates resulting from this approach
reasonably represent the highest levels to which an individual could be
exposed, and are unlikely to underestimate an individual's acute
dietary exposure. The Agency is reasonably certain that the percentage
of the food treated is not likely to be an underestimation. 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. Other than the data available
through national food consumption surveys, EPA does not have available
information on the regional consumption of food to which flufenacet may
be applied in a particular area.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for flufenacet 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 flufenacet.
The Agency uses the First Index Reservoir Screening Tool (FIRST) or
the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS),
to produce estimates of pesticide concentrations in an index reservoir.
The SCI-GROW model is used to predict pesticide concentrations in
shallow groundwater. For a screening-level assessment for surface water
EPA will use FIRST (a tier 1 model) before using PRZM/EXAMS (a tier 2
model). The FIRST model is a subset of the PRZM/EXAMS model that uses a
specific high-end runoff scenario for pesticides. While both FIRST and
PRZM/EXAMS incorporate an index reservoir environment, the PRZM/EXAMS
model includes a percent crop area factor as an adjustment to account
for the maximum percent crop coverage within a watershed or drainage
basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever exceed human health levels of concern.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs) from these models to quantify
drinking water exposure and risk as a %RfD or %PAD. Instead drinking
water levels of comparison (DWLOCs) are calculated and used as a point
of comparison against the model estimates of a pesticide's
concentration in water. DWLOCs are theoretical upper limits on a
pesticide's concentration in drinking water in light of total aggregate
exposure to a pesticide in food, and from residential uses. Since
DWLOCs address total aggregate exposure to flufenacet they are further
discussed in the aggregate risk section in Unit III.E.
Based on the PRZM/EXAMS and SCI-GROW models the estimated
environmental concentrations (EECs) of flufenacet for acute exposures
are estimated to be 9.9 parts per billion (ppb) for surface water and
0.21 ppb for ground water. The EECs for chronic exposures are estimated
to be 1.3 ppb for surface water and 0.21 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).

[[Page 37755]]

Flufenacet 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 flufenacet 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,
flufenacet 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 flufenacet 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 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 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. No increase in
susceptibility was seen in rat and rabbit developmental studies, but
qualitative and/or quantitative increases in susceptibility were seen
in the rat reproduction study and in the rat developmental
neurotoxicity studies.
3. Conclusion. The toxicology data base for flufenacet is complete
except for a special comparative assay on thyroid hormone levels in
neonatal and adult rats and a 28-day inhalation toxicity study in rats.
The exposure data are complete or are estimated based on data that
reasonably accounts for potential exposures.
The Agency evaluated the potential for increased susceptibility of
infants and children from exposure to flufenacet. The Agency concluded
that there is a low degree of concern and lack of residual
uncertainties for pre- and post-natal toxicity in the rat reproduction
study and the rat and rabbit developmental toxicity studies. The Agency
determined that the concern is also low for susceptibility seen in the
developmental neurotoxicity (DNT) study. Multiple offspring effects
were seen at the mid- and high doses, and no adverse maternal effects
were seen at any dose. However, the only effect seen at the lowest dose
in offspring was a transient decrease in body weight. The concern for
the decrease in the offspring weights was reduced because no decrease
in body weight was seen in the offspring in the reproduction study .
The Agency considered the lack of comparative data for thyroid
hormone levels in adult and neonatal animals. Available data support
the possibility of decreases in thyroid hormones in adult animals
(decreases were observed in several studies conducted in rats, mice,
rabbits, and dogs) at dose levels similar to those used in the
submitted DNT study. Because of the above concern, a special
comparative study on thyroid hormone levels in neonatal and adult rats
is being requested by the Agency as a condition of registration. The
Agency also noted that morphometric measurements could be incorporated
into the comparative thyroid assay to confirm the findings observed in
adult female offspring in the DNT (data for this endpoint were not
available at the low dose).
Due to the concerns regarding the possibility of decreases in
thyroid hormones and the need for comparative susceptibility data on
this issue as well as the lack of a NOAEL in the DNT, EPA found no
basis to remove the 10X FQPA safety for the protection of infants and
children. EPA considers this additional 10X factor to be an uncertainty
factor to address the deficiencies in the database.

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: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and
1L/10 kg (child). Default body weights and drinking water consumption
values vary on an individual basis. This variation will be taken into
account in more refined screening-level and quantitative drinking water
exposure assessments. Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
Acute, short-term, intermediate-term, chronic, and cancer.
When EECs for surface water and groundwater are less than the
calculated DWLOCs, OPP concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which OPP has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because OPP considers the aggregate risk resulting from
multiple exposure pathways associated with a pesticide's uses, levels
of comparison in drinking water may vary as those uses change. If new
uses are added in the future, OPP will reassess the potential impacts
of residues of the pesticide in drinking water as a part of the
aggregate risk assessment process.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food to
flufenacet will occupy 23% of the aPAD for the U.S. population, 17 % of
the aPAD for females 13 years and older, 23% of the aPAD for all
infants and 48% of the aPAD for children 1-2 years. In addition, there
is potential for acute dietary exposure to flufenacet in drinking
water. Table 4 of this unit presents the EECs and DWLOCs for the major
populations subgroups.

[[Page 37756]]

Table 4.--Aggregate Risk Assessment for Acute Exposure to Flufenacet
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup aPAD (mg/ % aPAD Water EEC Water EEC Acute DWLOC
kg) (Food) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population 0.0017 23 9.9 0.21 46
----------------------------------------------------------------------------------------------------------------
All Infants 0.0017 23 9.9 0.21 13
----------------------------------------------------------------------------------------------------------------
Children (1-2 yrs) 0.0017 48 9.9 0.21 9
----------------------------------------------------------------------------------------------------------------
Children (3-5 yrs) 0.0017 42 9.9 0.21 10
----------------------------------------------------------------------------------------------------------------
Children (6-12 yrs)]
0.0017 29 9.9 0.21 12
----------------------------------------------------------------------------------------------------------------
Youth (13-19 yrs) 0.0017 21 9.9 0.21 41
----------------------------------------------------------------------------------------------------------------
Adults (20-49 years) 0.0017 20 9.9 0.21 47
----------------------------------------------------------------------------------------------------------------
Females (13-19 years) 0.0017 17 9.9 0.21 42
----------------------------------------------------------------------------------------------------------------

The EECs are less than calculated DWLOCs for acute exposure to
flufenacet in drinking water, except for the population subgroup,
children 1-2 years old, where the EEC marginally exceeds the DWLOC.
In evaluating the acceptability of these estimated risks, EPA has
taken into account that the risk assessment was performed by estimating
exposure at the 99.9th percentile of exposure. As EPA has explained in
its policy regarding use of population percentiles in estimating
exposure, EPA generally uses the 95th percentile when conducting an
exposure assessment with unrefined residue values (i.e. assuming all
covered food contains tolerance level residues) and the 99.9th
percentile when using highly refined residue values (i.e. monitoring
values). See U.S. EPA, Office of Pesticide Programs, Choosing A
Percentile of Acute Dietary Exposure as a Threshold of Regulatory
Concern 17 (March 16, 2000) (http://www.epa.gov/pesticides/trac/
science/trac2b054.pdf). The residue values used in the flufenacet risk
assessment fall somewhere between highly refined and unrefined.
Although the Agency did use data bearing on percent crop treated, three
other aspects of the assessment made it not particularly refined, and
therefore, somewhat conservative (i.e. tending to overstate exposure).
First, EPA assumed tolerance level residues for all crops covered by
tolerances designed to address the possibility of flufenacet residues
being present in crops grown at a later date in the same field as the
treated crop. These rotational crop tolerances include rice and
sorghum. Further, compounding this conservative assumption, EPA assumed
that two percent of all of the crops covered by rotational crop
tolerances would contain flufenacet residues even though the treatment
rate for wheat and soybeans was at a one percent level (only corn was
at the two percent level) and it is unlikely, in any event, that the
crops covered by the rotational crop tolerances would, in their
entirety, be grown in a rotational program.
Second, and probably most important, for those crops for which EPA
did not assume tolerance level residues (corn, wheat, and soybeans) EPA
did not use monitoring data (i.e. data collected from food as it moves
in the channels of trade) but data from crop field trials. Crop field
trials are studies conducted to determine the maximum residue levels
that can occur under the limits imposed by the pesticide's label.
Accordingly, such studies involve applying the pesticide, pursuant to
its label, the maximum number of times at the maximum application rate
and harvesting the crop as promptly as soon as permitted following the
last pesticide treatment. These studies overstate the residue levels
that consumers are exposed to for two reasons. First, in crop field
studies, residue levels are measured at harvest and thus do not reflect
the degradation that generally occurs during the production, shipping,
and storage of food prior to sale to the consumer. Second, farmers are
not required to apply pesticides in the manner used in crop field
trials but generally may use lower amounts than those specified on the
label, apply the pesticide less frequently than the number of
applications permitted by the label, and wait longer to harvest the
crop than the minimum pre-harvest interval prescribed by the label. See
7 U.S.C. 136a(ee). Such practices reduce residue values, normally by
significant amounts. With flufenacet, the decrease will be even more
significant than usual because some of the field trial data are based
upon an application rate of 0.9 lbs. a.i. acre per season v.s. the
label rate of 0.79 lbs. a.i. acre per season for field corn and 0.9
lbs. a.i. acre per season v.s. the label rate of 0.45 lbs. a.i. per
acre per season for soybeans.
A third aspect of the flufenacet exposure assessment that
overstated residue levels was the fact that EPA did not use processing
reduction factors. Processing studies are performed in order to show
whether or not residues concentrate in processed commodities of the
RAC. For example wheat grain, may be processed into bran, flour,
middlings, shorts and germ. Processing studies frequently show residues
decreasing in the processed commodities. If the residues decrease in
the processed commodity, we may be able to determine a reduction
factor. The concentration and/or reduction factors are directly applied
to the residue level used in the dietary exposure assessment for that
commodity. The processing studies for flufenacet treated corn and
soybeans showed no detectable residues. However, the Agency for this
risk assessment assumed the residues in the raw agricultural commodity
were carried through undiminished to the processed commodities.
As EPA has made clear, even when an exposure assessment is based
on highly refined data, an indication that exposure at the 99.9th
percentile poses a risk of concern is merely the starting point for
assessing the ultimate safety of the pesticide. EPA has detailed a
number of steps that are important to assess the accuracy of any 99.9th
percentile estimate including sensitivity analyses and scrutiny of data
inputs. When an assessment does not rely on highly refined exposure
data there is an even greater need for close examination of

[[Page 37757]]

any risk estimates. As outlined above, there are several aspects of the
flufenacet exposure assessment that are likely to significantly inflate
exposure, and thus risk, estimates. Taking this into account as well as
the fact that a risk analysis using a 99.8th population percentile
raises the DWLOC for children between 1 and 2 years old to 12 ppb and
thus above the EEC of 9.9 ppb, EPA concludes that flufenacet does not
show a acute risk of concern.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
flufenacet from food will utilize <1 % of the cPAD for the U.S.
population, <1 % of the cPAD for all infants and 1.0 % of the cPAD for
children (1-2 yrs). In addition, there is potential for chronic dietary
exposure to flufenacet in drinking water. There are no residential uses
for flufenacet and therefore, no chronic residential exposure to
flufenacet. 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 Table 5 of this unit:

Table 5.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Flufenacet
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD mg/kg/ % cPAD Water EEC Water EEC Chronic
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population 0.0017 <1.0 1.3 0.21 59
----------------------------------------------------------------------------------------------------------------
All Infants 0.0017 <1.0 1.3 0.21 17
----------------------------------------------------------------------------------------------------------------
Children (1-2 yrs) 0.0017 1.0 1.3 0.21 17
----------------------------------------------------------------------------------------------------------------
Youth (13-19 yrs) 0.0017 <1.0 1.3 0.21 51
----------------------------------------------------------------------------------------------------------------
Adults (20-49 yrs) 0.0017 <1.0 1.3 0.21 59
----------------------------------------------------------------------------------------------------------------

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).
Flufenacet is not registered for use on any sites that would
result in residential exposure. Therefore, the aggregate risk is the
sum of the risk from food and water, which do not exceed the Agency's
level of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Flufenacet is not registered for use on any sites that would result
in residential exposure. Therefore, the aggregate risk is the sum of
the risk from food and water, which do not exceed the Agency's level of
concern.
5. Aggregate cancer risk for U.S. population. Flufenacet is not
carcinogenic, therefore no aggregate cancer risk is expected.
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 flufenacet residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology (gas chromotography /mass
spectrometry with selected ion monitoring) is available to enforce the
tolerance expression. The method may be requested from: Chief,
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail
address: residuemethods@epa.gov.
B. International Residue Limits

There are no Codex, Canadian, or Mexican tolerances for flufenacet
on corn, soybeans, wheat or livestock commodities.

C. Conditions

The following studies are required as a condition of registration.
1. A special comparative sensitivity study on thyroid hormone
levels in neonatal and adult rats.
2. 28-day inhalation toxicity study in rats.

V. Comments

One comment was received in response to the notice of filing from
B. Sachau, 15 Elm St., Florham Park, NJ 07932. Mr. Sachau objected
generally to the presence of pesticides in food and specifically to the
presence of flufenacet. Mr. Sachau also proposed that the U.S.
establish testing on humans instead of dogs and rats.
Mr. Sachau comment contained no scientific data or evidence to
rebut the Agency's conclusion that there is a reasonable certainty that
no harm will result from aggregate exposure to flufenacet, including
all anticipated dietary exposures and all other exposures for which
there is reliable information.

VI. Conclusion

Therefore, the tolerance is established for combined residues of
flufenacet, ( N-(4-fluorophenyl)-N-(1-methylethyl)-2-[[5-
(trifluoromethyl)-1,3,4-thiadiazol-2-yl]oxy]acetamide) and its
metabolites containing the 4-fluoro-N-methylethyl benzenamine moiety]
on corn, field, forage at 0.4 ppm; corn, field, grain at 0.05 ppm;
corn, field, stover at 0.4 ppm; soybean, seed at 0.1 ppm by
establishing permanent tolerances for indirect or inadvertent residues
of the herbicide flufenacet, (N-(4-fluorophenyl)-N-(1-methylethyl)-2-
[[5-(trifluoromethyl)-1,3,4- thiadiazol-2-yl]oxy]acetamide) and its
metabolites containing the 4-fluoro-N-methylethyl benzenamine moiety in
or on the following raw agricultural commodities from the application
of this herbicide to the raw agricultural commodities, listed in 40 CFR
180.527 (a) and (b), alfalfa, forage at 0.1 ppm; alfalfa, hay at 0.1
ppm; alfalfa, seed at 0.1 ppm; clover, forage at 0.1 ppm; clover, hay
at 0.1 ppm; grain, cereal, group 15, except rice at 0.1 ppm; grain,
cereal, forage, fodder, and straw, group 16, except rice, at 0.1 ppm;
and grass, forage, fodder and hay, group 17 at 0.1 ppm. These
tolerances replaced currently expiring tolerances in Sec. 180.527 (a)
and (d).

VII. 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

[[Page 37758]]

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 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-2003-0181 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 August
25, 2003.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900C),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Rm.104, Crystal Mall #2, 1921
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Office of the Hearing Clerk is
(703) 603-0061.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at 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 VII.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.1. Mail your
copies, identified by docket ID number OPP-2003-0181, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the
PIRIB described in Unit I.B.1. You may also send an electronic copy of
your request via e-mail to: 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).

VIII. Statutory and Executive Order Reviews

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 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

[[Page 37759]]

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.

IX. Congressional Review Act

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and record
keeping requirements.

Dated: June 12, 2003.
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), 346(a) and 371.

¥ 2. Section 180.527 is amended by revising paragraphs (a) and (d) to
read as follows:

Sec. 180.527 N-(4-fluorophenyl)-N-(1-methylethyl)-2-[(5-
(trifluoromethyl)-1,3,4-thiadiazol-2-yl)oxy]acetamide; tolerances for
residues.

(a) General. Tolerances are established for the combined residues
of the herbicide N-(4-fluorophenyl)-N-(1-methylethyl)-2-[(5-
(trifluoromethyl)-1,3,4-thiadiazol-2-yl)oxy]acetamide and its
metabolites containing the 4-fluoro-N-methylethyl benzenamine moiety in
or on the following raw agricultural commodities:

* * * * *
(d) Indirect or inadvertent residues. Tolerances are established
for indirect or inadvertent residues of the herbicide N-(4-
fluroophenyl)-N-(1-methylethyl)-2-[(5-(trifluoromethyl)-1,3,4-
thiadiazol-2-yl)oxy]acetamide and its metabolites containing the 4-
fluoro-N-methylethyl benzenamine moiety in or on the raw agricultural
commodities listed in paragraph (a) of this section.

------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Alfalfa, forage................................ 0.1
Alfalfa, hay................................... 0.1
Alfalfa, seed.................................. 0.1
Clover, forage................................. 0.1
Clover, hay.................................... 0.1
Grain, cereal, group 15, except rice........... 0.1
Grain, cereal, forage, fodder, and straw, group 0.1
16, except rice...............................
Grass, forage, fodder, and hay, group 17....... 0.1
------------------------------------------------------------------------

[FR Doc. 03-15905 Filed 6-24-03; 8:45 am]
BILLING CODE 6560-50-S