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Butafenacil (Syngenta). September
19, 2003. Pesticide Tolerance. Final Rule. Federal
Register.
Note from
FAN:
The metabolite, or dimer of butafenacil, is included in the tolerances for
residues for livestock commodoties: CGA-293731 (1-carboxy-1-methylethyl 2-
chloro-5-[3,6-dihydro-3-methyl-2,6-dioxo-4-(trifluoromethyl)-1(2H)- pyrimidinyl]
benzoate)
http://www.epa.gov/fedrgstr/EPA-PEST/2003/September/Day-19/p23853.htm
[Federal Register: September 19, 2003 (Volume 68, Number 182)]
[Rules and Regulations]
[Page 54818-54827]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19se03-11]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2003-0282; FRL-7324-6]
Butafenacil; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a tolerance for residues of
butafenacil (1,1-dimethyl-2-oxo-2-(2-propenyloxy)ethyl 2-chloro-5-[3,6-
dihydro-3-methyl-2,6-dioxo-4-(trifluoromethyl)-1(2H)-pyrimidinyl]
benzoate) in or on cotton and livestock commodities. Syngenta Crop
Protection, Inc. 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 September 19, 2003. Objections and
requests for hearings, identified by docket ID number OPP-2003-0282,
must be received on or before November 18, 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 VI. of the SUPPLEMENTARY
INFORMATION.
FOR FURTHER INFORMATION CONTACT: Jim 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:
[sbull]
Crop production (NAICS 111)
[sbull]
Animal production (NAICS 112)
[sbull]
Food manufacturing (NAICS 311)
[sbull]
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. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in Unit II. 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-2003-0282. The
official public 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 February 26, 2003 (68 FR 8896) (FRL-
7293-9), 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 a pesticide petition (PP 1F6309) by Syngenta Crop Protection,
Inc., P.O. Box 18300, Greensboro, NC 27419-8300. That notice included a
summary of the petition prepared by Syngenta Crop Protection, Inc., the
registrant. There were no comments received in response to the notice
of filing.
The petition requested that 40 CFR part 180 be amended by
establishing a tolerance for residues of the herbicide butafenacil, the
[2+2]
cycloaddition dimer of butafenacil, and CGA-293731 in or on
cotton, undelinted seed at 0.5 parts per million (ppm); and in or on
cotton, gin byproducts at 13.0 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 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
[[Page 54819]]
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 butafenacil and
CGA-293731 on cattle, kidney; goat, kidney; hog, kidney; horse, kidney;
and sheep, kidney at 0.05 parts per million (ppm); in or on cattle,
liver; goat, liver; hog, liver; horse, liver; and sheep, liver at 0.50
ppm; and tolerances for residues of butafenacil in or on cotton,
undelinted seed at 0.50 ppm; and in or on cotton, gin byproducts at 10
ppm. EPA's assessment of exposures and risks associated with
establishing these tolerances 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 butafenacil 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.--Acute Toxicity of Butafenacil
----------------------------------------------------------------------------------------------------------------
Guideline number Study Type Results Toxicity Category
----------------------------------------------------------------------------------------------------------------
870.1100 Acute oral Lethal dose (LD)50 IV
>5,000 milligrams/
kilogram (mg/kg) male
and female (M/F)
-----------------------------------------------------------------------------------------
870.1200 Acute dermal LD50 >2,000 mg/kg M/F III
-----------------------------------------------------------------------------------------
870.1300 Acute inhalation Lethal concentration IV
(LC)50 >5.10
milligrams per Liter
(mg/L)
-----------------------------------------------------------------------------------------
870.2400 Primary eye irritation Ocular irritation III
resolved within 96
hours
-----------------------------------------------------------------------------------------
870.2500 Primary skin irritation Not an irritant IV
-----------------------------------------------------------------------------------------
870.2600 Dermal sensitization Not a sensitizer Not Applicable (NA)
----------------------------------------------------------------------------------------------------------------
Table 2.--Subchronic, Chronic, and Other Toxicity
------------------------------------------------------------------------
Guideline number Study Type Results
------------------------------------------------------------------------
870.3100 90-Day oral NOAEL = 300 ppm
(dietary) (18.8/20.6 mg/kg/
toxicity rodents day M/F)
(rat) LOAEL = 1,000 ppm
(62.3/69.3 mg/kg/
day M/F), based on
decreased body
weight gains,
decreased
hemoglobin,
hematocrit, mean
corpuscular
hemoglobin (MCH),
mean corpuscular
volume (MCV),
increased red cell
volume, increased
bone marrow
hypercellularity;
increased bilirubin
and urobilinogen;
increased alanine
aminotransferase;
hepatocyte
necrosis;
inflammatory liver
cell infiltration
------------------------------------------------------------------------
870.3100 90-Day oral NOAEL = 30 ppm (4.11/
(dietary) 5.67 mg/kg/day M/F)
toxicity in LOAEL = 100 ppm
rodents (mouse) (13.8/20.1 mg/kg/
day M/F), based on
hepatic
histopathology:
fatty change,
glycogen
deposition, and
hypertrophy in both
sexes
------------------------------------------------------------------------
870.3150 90-Day oral NOAEL = 200 mg/kg/
(capsule) day M/F
toxicity in non- LOAEL = 1,000 mg/kg/
rodents (dog) day M/F, based on
decreases in MCV
and MCH in males;
increases in RDW,
HDW, platelets and
triglycerides in
males; and
hemosiderosis in
spleen and liver
and extramedullary
hematopoiesis the
spleen in males
------------------------------------------------------------------------
870.3200 28-Day dermal NOAEL = 1,000 mg/kg/
toxicity (rat) day
LOAEL = not
determined
------------------------------------------------------------------------
870.3700 Prenatal Maternal NOAEL =
developmental 1,000 mg/kg/day
toxicity in Maternal LOAEL = not
rodents (rat) determined
Developmental NOAEL
= 1,000 mg/kg/day
Developmental LOAEL
= not determined
------------------------------------------------------------------------
870.3700 Prenatal Maternal NOAEL = 100
developmental mg/kg/day
toxicity in non- Maternal LOAEL =
rodents (rabbit) 1,000 mg/kg/day
based on decreased
body weight gains
and food
consumption during
the treatment
period, and on
blood-stained
vaginal discharge
(related to total
litter loss) in two
doses
Developmental NOAEL
= 100 mg/kg/day
Developmental LOAEL
= 1,000 mg/kg/day
based on increased
early resorptions
and post-
implantation loss
------------------------------------------------------------------------
[[Page 54820]]
870.3800 2-Generation Parental/systemic
reproduction and NOAEL = 30 ppm (2.4/
fertility 2.5 mg/kg/day M/F)
effects Parental/systemic
LOAEL = 300 ppm
(23.8/25.2 mg/kg/
day M/F), based on
decreased body
weights and food
consumption and on
increased
incidences of bile
duct hyperplasia
and liver necrosis
in males and
females of both
generations
Offspring NOAEL =
300 ppm (23.8/25.2
mg/kg/day M/F)
Offspring LOAEL =
1,000 ppm (79.6/
83.8 M/F), based on
decreased pup body
weight and body
weight gain in both
generations
Reproductive NOAEL =
30 ppm (2.4/2.5 mg/
kg/day M/F)
Reproductive LOAEL =
300 ppm (23.8/25.2
mg/kg/day M/F)
based on an
increase in the
number of days to
mating in both
generations
------------------------------------------------------------------------
870.4100 1-Year chronic NOAEL = 500 mg/kg/
oral (capsule) day M/F
toxicity (dog) LOAEL = 1,000 mg/kg/
day M/F, based on
decreased body
weight gain in
males, decreased
MCV, MCH, and mean
corpuscular
hemoglobin
concentration
(MCHC); increased
thrombocytes and
red cell volume
distribution width;
hepatic
histopathology:
glycogen
disposition,
inclusion bodies in
cytoplasm, and
pigment disposition
in both sexes, and
focal vaculolation
in females
------------------------------------------------------------------------
870.4200 18-Month NOAEL = 10 ppm (1.17/
carcinogenicity 1.20 mg/kg/day M/F)
dietary study LOAEL = 60 ppm (6.96/
(mouse) 6.59 mg/kg/day M/
F), based on
enlarged livers
with increased
weights, and
hepatic microscopic
lesions including
Kupffer cell
hyperplasia,
inflammatory cell
infiltration, and
single cell
necrosis in both
sexes and on
deposits of
lipofuscin in males
No evidence of
carcinogenicity
------------------------------------------------------------------------
870.4300 Combined 2-Year NOAEL = 100 ppm
chronic/ (3.76/4.43 mg/kg/
carcinogenicity day M/F)
dietary study LOAEL = 300 ppm
(rat) (11.4/13.0 mg/kg/
day M/F), based on
minimal hepatic
abnormalities in
the females,
including a fatty
change and
increased mitotic
activity
No evidence of
carcinogenicity
------------------------------------------------------------------------
870.5100 In vitro Negative in a
bacterial gene reverse gene
mutation mutation assay in
strains TA98,
TA100, TA102,
TA1535, TA1537 of
S. typhimurium and
strain WP2(uvrA) of
E. coli in the
presence and
absence of
mammalian metabolic
activation
------------------------------------------------------------------------
870.5300 In vitro Evidence of
mammalian cells borderline
in culture induction of mutant
colonies in
presence of S9 in a
mammalian cell gene
mutation assay at
the hypoxanthine
guanine
phophoribosyl
transferase (HGPRT)
locus of Chinese
hamster V79 cells
------------------------------------------------------------------------
870.5375 In vitro Negative. No
mammalian evidence of
cytogenetics increase in
chromosome
aberrations over
background
------------------------------------------------------------------------
870.5395 In vivo mammalian Negative. No
cytogenetics - increase in
micronucleus frequency of
assay (mouse) micronucleated
polychromatic
erythrocytes
------------------------------------------------------------------------
870.5550 Other Negative. No
genotoxicity - evidence of
unscheduled DNA induction of UDS;
synthesis (UDS)- no indications of
in vivo/in vitro induction of DNA
damage
------------------------------------------------------------------------
870.5550 Other Negative. No
genotoxicity - evidence of
UDS - in vitro induction of UDS;
no indications of
induction of DNA
damage in primary
rat hepatocytes in
culture
------------------------------------------------------------------------
870.6200 Acute NOAEL = 2,000 mg/kg
neurotoxicity LOAEL = Not
screening determined
battery (rat) No evidence of
neurotoxicity
------------------------------------------------------------------------
870.6200 Subchronic NOAEL = 300 ppm 21/
neurotoxicity 24 mg/kg/day M/F
screening LOAEL = 1,000 ppm 72/
battery (rat) 76 mg/kg/day M/F,
based on liver
histopathology and
decreased motor
activity at week 13
in the males
No evidence of
neurotoxicity
------------------------------------------------------------------------
[[Page 54821]]
870.7485 Metabolism and Overall recovery of
pharmacokinetics administered
(rat) radioactivity
exceeded 95%, most
(74-93%) of which
was eliminated in
the feces.
Approximately 4-15%
of the administered
radioactivity was
excreted in the
urine over 168
hours while tissue
residues were
negligible, thereby
implying limited
absorption. No
radioactivity was
detected in expired
air. Excretion of
radioactivity was
>90% complete by 48
hours. Up to six
components were
detected in the
urine of rats from
both dose groups,
the most prevalent
being an hydrolysis
product, CGA-293731
which represented
>90% of urinary
radioactivity.
Urinary elimination
of metabolites was
quantitatively
greater in female
rats than in males.
Only minor amounts
(near detection
limits) of parent
compound were
detected in the
urine of high-dose
males. Based upon
biliary
elimination, -74-
79% of the dose
entered the
hepatobiliary
pathway but was
eliminated via the
feces. An increase
in parent compound
in feces of the
high-dose group was
indicative of
saturated
absorption and/or
saturated
metabolism, but
could not be
definitively
resolved due to the
absence of biliary
elimination studies
at the high dose.
Biliary elimination
studies revealed
that approximately
60-64% of the
administered low
dose was detected
in 0-4 hour pooled
bile samples and
that the majority
of fecal
radioactivity could
be attributed to
biliary metabolites
------------------------------------------------------------------------
870.7485 Mechanistic Effects on enzymes
studies of cultured mouse,
rat, and/or human
hepatocytes
involved with heme
biosynthesis
------------------------------------------------------------------------
870.7485 Mechanistic Effects on liver
studies microsomal and
plasma protox
activity and its
metabolic
conversion
------------------------------------------------------------------------
870.7485 Mechanistic Effects on porphyrin
studies profile in rats;
treatment induced
porphyria,
consisting of
accumulation of
selected porphyrins
in the liver,
spleen, and plasma
and increased
excretion in urine
and feces
------------------------------------------------------------------------
870.7485 Mechanistic Test substance
studies interferes with
heme biosynthesis
in rats, as
evidenced by dose-
dependent,
pronounced
porphyria in the
liver, spleen, and
plasma; increased
porphyrin
excretion, and
decreased activity
of various
isoenzymes of the
hepatic microsomal
cytochrome P450
system
------------------------------------------------------------------------
870.7485 Mechanistic Test substance
studies interferes with
heme biosynthesis
in mice, as
evidenced by dose-
dependent,
pronounced
porphyria in the
liver, spleen, and
plasma; increased
porphyrin
excretion, and
decreased activity
of various
isoenzymes of the
hepatic microsomal
cytochrome P450
system
------------------------------------------------------------------------
870.7485 Mechanistic Effects on porphyrin
studies profile in mice;
treatment induced
porphyria,
consisting of
accumulation of
selected porphyrins
in the tissue and
plasma, and
increased excretion
of heme precursors
------------------------------------------------------------------------
B. Toxicological Endpoints
The dose at which the NOAEL from the toxicology study identified as
appropriate for use in risk assessment is used to estimate the margin
of exposure (MOE). 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. A UF of 100 is routinely
used, 10X to account for interspecies differences and 10X for
intraspecies differences.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). Where an additional safety factors
(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 level of concern (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.
A summary of the toxicological endpoints for butafenacil used for
human risk assessment is shown in Table 3 of this unit:
[[Page 54822]]
Table 3.--Toxicological Dose and Endpoints for Butafenacil
----------------------------------------------------------------------------------------------------------------
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 None NA An endpoint
including infants and children) attributable to a
single dose is not
available in the data
base
-----------------------------------------------------------------------------------------
Chronic dietary (All populations) NOAEL= 1.2 mg/kg/day UF Special FQPA SF = 1 Mouse oncogenicity
= 100 cPAD = chronic RfD..... study
Chronic RfD = 0.012 mg/ Special FQPA SF = 0.012 The LOAEL is 6.96 mg/kg/
kg/day. mg/kg/day. day, based on enlarged
livers with increased
weights, and hepatic
microscopic lesions
including Kupffer cell
hyperplasia,
inflammatory cell
infiltration, and
single cell necrosis
in both sexes and on
deposits of lipofuscin
in males
-----------------------------------------------------------------------------------------
Short-term inhalation (1 to 30 days) Oral NOAEL = 18.8 mg/kg/ Residential LOC for MOE 90-day rat feeding
day = 100 study
Occupational = 100..... The LOAEL for this
study is 62.3 mg/kg/
day based on decreased
hemoglobin,
hematocrit, mean
corpuscular
hemoglobin, mean
corpuscular volume,
increased red cell
volume distribution
width, and increased
incidence of bone
marrow
hypercellularity
-----------------------------------------------------------------------------------------
Short-term incidental oral (1 to 30 NOAEL = 18.8 mg/kg/day Residential LOC for MOE 90-day rat feeding
days) = 100 study
Occupational = NA...... The LOAEL for this
study is 62.3 mg/kg/
day, based on
decreased hemoglobin,
hematocrit, mean
corpuscular
hemoglobin, mean
corpuscular volume,
increased red cell
volume distribution
width, and increased
incidence of bone
marrow
hypercellularity
-----------------------------------------------------------------------------------------
Intermediate-term incidental oral (1- NOAEL = 18.8 mg/kg/day Residential LOC for MOE 90-day rat feeding
6 months) = 100 study
Occupational = NA...... The LOAEL for this
study is 62.3 mg/kg/
day, based on
decreased hemoglobin,
hematocrit, mean
corpuscular
hemoglobin, mean
corpuscular volume,
increased red cell
volume distribution
width, and increased
incidence of bone
marrow
hypercellularity
-----------------------------------------------------------------------------------------
Dermal (All durations) NA NA Quantification of
dermal risk assessment
is not required due to
lack of concern for
dermal, systemic or
developmental toxicity
-----------------------------------------------------------------------------------------
Short-term inhalation (1 to 30 days) Oral NOAEL = 18.8 mg/kg/ Residential LOC for MOE 90-day rat feeding
day = 100 study
Occupational = 100..... The LOAEL for this
study is 62.3 mg/kg/
day based on decreased
hemoglobin,
hematocrit, mean
corpuscular
hemoglobin, mean
corpuscular volume,
increased red cell
volume distribution
width, and increased
incidence of bone
marrow
hypercellularity
-----------------------------------------------------------------------------------------
Intermediate-term inhalation (1 to 6 Oral NOAEL = 18.8 mg/kg/ Residential LOC for MOE 90-day rat feeding
months) day = 100 study
Occupational = 100..... The LOAEL for this
study is 62.3 mg/kg/
day, based on
decreased hemoglobin,
hematocrit, mean
corpuscular
hemoglobin, mean
corpuscular volume,
increased red cell
volume distribution
width, and increased
incidence of bone
marrow
hypercellularity
-----------------------------------------------------------------------------------------
[[Page 54823]]
Long-term inhalation (>6 months) Oral NOAEL = 1.2 mg/kg/ Residential LOC for MOE Mouse oncogenicity
day = 100 study
Occupational = 100..... The LOAEL is 6.96 mg/kg/
day, based on enlarged
livers with increased
weights, and hepatic
microscopic lesions
including Kupffer cell
hyperplasia,
inflammatory cell
infiltration, and
single cell necrosis
in both sexes and on
deposits of lipofuscin
in males
-----------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) NA NA Classified as ``not
likely to be
carcinogenic to
humans''
----------------------------------------------------------------------------------------------------------------
* The reference to the Special 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. No tolerances have
previously been established for butafenacil. Risk assessments were
conducted by EPA to assess dietary exposures from butafenacil in food
as follows:
i. Acute exposure. Quantitative 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 1-day or single exposure. No appropriate endpoint attributable to
a single exposure was identified for butafenacil in either the general
population or to the subpopulation of females 13-50 years old,
therefore no acute exposure assessment was performed.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment, the Dietary Exposure Evaluation Model Food Commodity Intake
Database (DEEM-FCID[reg]) 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: The dietary
exposure analysis assumed 100% crop treated and tolerance level
residues or maximum field trial residues. Based on total food exposure
for butafenacil, all population subgroups are below 1% cPAD.
iii. Cancer. Butafenacil showed no evidence of carcinogenicity in
animal tests in two different species, and therefore, a quantitative
cancer risk assessment was not performed.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for butafenacil 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 butafenacil.
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 screening concentration in ground water (SCI-GROW) model is used to
predict pesticide concentrations in shallow ground water. For a
screening-level assessment for surface water EPA will use FIRST (a Tier
I model) before using PRZM/EXAMS (a Tier II 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 LOC.
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 butafenacil they are further
discussed in Unit III.E.
Based on the FIRST and SCI-GROW models, the EECs of butafenacil for
chronic exposures are estimated to be 0.049 parts per billion (ppb) for
surface water and 0.00095 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). Butafenacil is not
proposed for registration for use on any sites that would result in
residential exposure.
4. Cumulative effects from 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 butafenacil has a common mechanism of toxicity with other
substances. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity, EPA
has not made a common mechanism of toxicity finding as to butafenacil
and any other substances
[[Page 54824]]
and butafenacil 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 butafenacil 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 policy statements released by EPA's Office of Pesticide Programs
concerning common mechanism determinations and procedures for
cumulating effects from substances found to have a common mechanism on
EPA's website at http://www.epa.gov/pesticides/cumulative/.
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. There are no residual
concerns regarding prenatal or postnatal toxicity or completeness of
the toxicity or exposure data base.
3. Conclusion. There is a complete toxicity data base for
butafenacil and exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures. EPA determined
that the 10X SF to protect infants and children could be reduced to 1X.
The FQPA factor was reduced because:
[sbull]
There is no quantitative or qualitative evidence of
increased susceptibility of rat and rabbit fetuses to in utero exposure
in developmental studies or to in utero and postnatal exposure to rats
in the 2-generation reproduction study.
[sbull]
There are no residential uncertainties for prenatal or
postnatal toxicity.
[sbull]
The toxicological data base is complete for the assessment
of toxicity and susceptibility following prenatal and/or postnatal
exposures. No clinical signs of neurotoxicity or neuropathology were
observed in the data base, and the developmental neurotoxicity study
was not required.
[sbull]
There are no residual concerns regarding prenatal or
postnatal toxicity or completeness of the toxicity or exposure data
base.
[sbull]
The dietary food exposure assessment is Tier I, screening
level, which is based on tolerance level residues or maximum field
trial residues and assumes 100% of all crops will be treated with
chemical. By using these screening level assessments, actual exposures/
risks will not be underestimated.
[sbull]
The dietary drinking water assessment utilizes water
concentration values generated by health protective, high-end estimates
of water concentrations which will not likely be exceeded.
[sbull]
There are currently no registered residential uses of
butafenacil.
[sbull]
These assessments will not underestimate the exposure/risks
posed by current or proposed uses of butafenacil.
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 EPA's Office of Water are used to calculate DWLOCs: 2
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 ground water are less than the
calculated DWLOCs, EPA concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which EPA has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because EPA 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, EPA 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. No acute risk from exposure to butafenacil is
expected because there were no toxic effects of concern attributable to
a single dose identified in available data.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
butafenacil from food will utilize <1% of the cPAD for the U.S.
population, <1% of the cPAD for infants ages 1-2, and <1% of the cPAD
for children ages 3-5. There are no proposed residential uses for
butafenacil that result in chronic residential exposure to butafenacil.
In addition, there is potential for chronic dietary exposure to
butafenacil in drinking water. After calculating DWLOCs and comparing
them to the EECs for surface water and ground water, EPA does not
expect the aggregate exposure to exceed 100% of the cPAD, as shown in
Table 4 of this unit:
[[Page 54825]]
Table 4.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Butafenacil
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chronic Food
Population cPAD (mg/kg/day) % cPAD (mg/kg/day) Exposure1 (mg/kg/ Ground Water EEC2 Surface Water EEC2 Chronic DWLOC3
day) (ppb) (ppb) (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
General U.S. population 0.012 <1% 0.000041 0.00095 0.049 420
--------------------------------------------------------------------------
All infants (< 1 year old) 0.012 <1% 0.000014 0.00095 0.049 120
--------------------------------------------------------------------------
Children (1-2 years old) 0.012 <1% 0.000097 0.00095 0.049 120
--------------------------------------------------------------------------
Children (3-5 years old) 0.012 <1% 0.000104 0.00095 0.049 120
--------------------------------------------------------------------------
Children (6-12 years old) 0.012 <1% 0.000069 0.00095 0.049 120
--------------------------------------------------------------------------
Youth (13-19 years old) 0.012 <1% 0.000036 0.00095 0.049 360
--------------------------------------------------------------------------
Adults (20-49 years old) 0.012 <1% 0.000033 0.00095 0.049 420
--------------------------------------------------------------------------
Females (13-49 years old) 0.012 <1% 0.000030 0.00095 0.049 360
--------------------------------------------------------------------------
Adults (50+ years old) 0.012 <1% 0.000031 0.00095 0.049 420
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Maximum chronic water exposure (mg/kg/day) = cPAD (mg/kg/day) - chronic food exposure from DEEM (mg/kg/day); no res. exp.
\2\ Parent plus CGA-293731; cotton application scenario - 1 x 0.141 lb ai/acre; maximum proposed rate
\3\ DWLOC([mu]g/L) = (allowable water exposure (mg/kg/day) x body weight (kg) x 1,000 [mu]g/mg) / (water consumption (liters)) Consumption = 1 L/day for
populations <13 years old and 2 L/day for populations 3 13 years old. Default body weights = 70 kg for general U.S. population and adult males, 60 kg
for youth and females 3 13 years old, and 10 kg for all others.
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). Butafenacil is not
proposed for registrations 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 LOC.
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). Butafenacil
is not proposed for registrations 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
LOC.
5. Aggregate cancer risk for U.S. population. Butafenacil is not
expected to pose a cancer risk because no evidence of carcinogenicity
was found in adequate animal tests in two different species, therefore
no aggregate cancer risk assessment was performed.
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 butafenacil residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Syngenta Crop Protection, Inc. proposed Syngenta Method 131-99 for
enforcement of the proposed cotton tolerances (adequate validation,
independent laboratory validation (ILV), and radiovalidation data have
been submitted). The petitioner did not propose ruminant liver and
kidney tolerances and therefore did not propose a method for
enforcement of the recommended ruminant liver and kidney tolerances.
The petitioner has and will submit an enforcement method, adequate
validation, ILV, and radiovalidation for enforcement of the ruminant
liver and kidney tolerances as a condition of registration.
B. International Residue Limits
Canada, Codex, and Mexico do not have maximum residue limits for
residues of butafenacil in/on cotton. Therefore, harmonization is not
an issue.
C. Conditions
As a condition of registration, the petitioner must submit:
1. A ruminant liver and kidney enforcement method and submit
adequate validation, ILV, and radiovalidation data.
2. Submit confirmatory data on the frozen storage stability of
residues of butafenacil in or on cottonseed, cotton gin byproduct,
cotton hull, cotton meal, and cotton oil.
3. Submit a ruminant feeding study to confirm the Agency's estimate
of maximum residues of butafenacil from the goat metabolism study.
V. Conclusion
Therefore, the tolerance is established for residues of
butafenacil, in or on cattle, kidney; goat, kidney; hog, kidney; horse,
kidney; and sheep, kidney at 0.05 ppm; in or on cattle, liver; goat,
liver; hog, liver; horse, liver; and sheep, liver at 0.50 ppm; in or on
cotton, undelinted seed at 0.50 ppm; and in or on cotton, gin
byproducts at 10 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 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.
[[Page 54826]]
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-2003-0282 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
18, 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 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.1. Mail your
copies, identified by docket ID number OPP-2003-0282, 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).
VII. 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 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
[[Page 54827]]
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 (65 FR
67249, November 6, 2000). Executive Order 13175, requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by tribal officials in the development of regulatory policies that have
tribal implications.'' ``Policies that have tribal implications'' is
defined in the Executive Order to include regulations that have
``substantial direct effects on one or more Indian tribes, on the
relationship between the Federal Government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes.'' This rule will not have substantial
direct effects on tribal governments, on the relationship between the
Federal Government and Indian tribes, or on the distribution of power
and responsibilities between the Federal Government and Indian tribes,
as specified in Executive Order 13175. Thus, Executive Order 13175 does
not apply to this rule.
VIII. 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
recordkeeping requirements.
Dated: September 10, 2003.
James Jones,
Director, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346(a) and 371.
0
2. Section 180.592 is added to read as follows:
Sec. 180.592 Butafenacil; tolerances for residues.
(a) General. (1) Tolerances are established for residues of the
herbicide butafenacil, (1,1-dimethyl-2-oxo-2-(2-propenyloxy)ethyl 2-
chloro-5-[3,6-dihydro-3-methyl-2,6-dioxo-4-(trifluoromethyl)-1(2H)-
pyrimidinyl]
benzoate) in or on the following raw agricultural
commodities:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Cotton, gin byproducts............................... 10
Cotton, undelinted seed.............................. 0.50
------------------------------------------------------------------------
(2) Tolerances are established for residues of the herbicide
butafenacil, (1,1-dimethyl-2-oxo-2-(2-propenyloxy)ethyl 2-chloro-5-
[3,6-dihydro-3-methyl-2,6-dioxo-4-(trifluoromethyl)-1(2H)-pyrimidinyl]
benzoate) and its metabolite CGA-293731 (1-carboxy-1-methylethyl 2-
chloro-5-[3,6-dihydro-3-methyl-2,6-dioxo-4-(trifluoromethyl)-1(2H)-
pyrimidinyl]
benzoate), in or on the following livestock commodities:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Cattle, kidney....................................... 0.05
Cattle, liver........................................ 0.50
Goats, kidney........................................ 0.05
Goats, liver......................................... 0.50
Hog, kidney.......................................... 0.05
Hog, liver........................................... 0.50
Horse, kidney........................................ 0.05
Horse, liver......................................... 0.50
Sheep, kidney........................................ 0.05
Sheep, liver......................................... 0.50
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect and inadvertant residues. [Reserved]
[FR Doc. 03-23853 Filed 9-18-03; 8:45 am]
BILLING CODE 6560-50-S