[Federal Register Volume 68, Number 182 (Friday, September 19, 2003)]
[Rules and Regulations]
[Pages 54818-54827]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-23853]


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

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: [email protected].

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 >= 13 years old. Default body weights = 70 kg for general U.S. population and adult males, 60 kg
  for youth and females >= 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 [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
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: [email protected]. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 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