[Federal Register Volume 68, Number 98 (Wednesday, May 21, 2003)]
[Rules and Regulations]
[Pages 27729-27740]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-12359]


=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0163; FRL-7306-1]


Pyraflufen-ethyl; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes a tolerance for combined residues 
of pyraflufen-ethyl in or on cotton. Nichino America Incorporated 
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 May 21, 2003. Objections and 
requests for hearings, identified by docket ID number OPP-2003-0163, 
must be received on or before July 21, 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: Joanne I. Miller, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington,

[[Page 27730]]

DC 20460-0001; telephone number: (703) 305-6224; 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 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. 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-2003-0163. 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 November 20, 2002 (67 FR 70073) (FRL-
7184-7), 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 (1F6428) by Nichino America 
Incorporated, 4550 New Linden Hill Road, Suite 501, Wilmington, DE 
19808. That notice included a summary of the petition prepared by 
Nichino America Incorporated, the registrant. There were no comments 
received in response to the notice of filing.
    The petition requested that 40 CFR 180.585 be amended by 
establishing tolerances for combined residues of the herbicide 
pyraflufen-ethyl (ethyl 2-chloro-5-(4-chloro-5-difluoromethoxy-1-
methyl-1H-pyrazol-3-yl)-4-fluorophenoxyacetate) and its acid 
metabolite, E-1 (2-chloro-5-(4-chloro-5-difluoromethoxy-1-methyl-1H-
pyrazol-3-yl)-4-fluorophenoxyacetic acid), expressed as the ester 
equivalent in or on cotton undelinted seed at 0.05 parts per million 
(ppm) and cotton gin byproduct at 1.5 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 November 26, 1997) (62 FR 62961) (FRL-
5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed 
the available scientific data and other relevant information in support 
of this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2) of the FFDCA, for tolerances for residues of pyraflufen-ethyl 
on cotton undelinted seed at 0.04 ppm and cotton gin byproduct at 1.5 
ppm. EPA's assessment of exposures and risks associated with 
establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by pyraflufen-ethyl 
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.

[[Page 27731]]



            Table 1.--Subchronic, Chronic, and Other Toxicity
------------------------------------------------------------------------
         Guideline No.              Study Type            Results
------------------------------------------------------------------------
870.3100                        90-day oral        NOAEL = 5,000 parts
                                 toxicity in rats   per million (ppm)
                                                    (456-499 milligrams/
                                                    kilograms/day (mg/kg/
                                                    day)).
                                                   LOAEL = 15,000 ppm
                                                    (1,489-1,503 mg/kg/
                                                    day) based on
                                                    clinical signs,
                                                    death, effects on
                                                    erythrocytes,
                                                    changes in clinical
                                                    chemicals for liver
                                                    function and
                                                    splenomegaly.
-------------------------------
870.3150                        90-day oral        NOAEL = 1,000 mg/kg/
                                 toxicity in dogs   day.
                                                   LOAEL not
                                                    established, no
                                                    effects observed.
-------------------------------
870.3200                        28-Day dermal      NOAEL = 1,000 mg/kg/
                                 toxicity in rats   day.
                                                   LOAEL not
                                                    established; no
                                                    effects observed.
-------------------------------
870.3700                        Prenatal           Maternal NOAEL >=
                                 developmental in   1,000 mg/kg/day
                                 rats              Maternal LOAEL not
                                                    determined; no
                                                    effects observed.
                                                   Developmental NOAEL
                                                    >= 1,000 mg/kg/day.
                                                   Developmental LOAEL
                                                    not determined; no
                                                    effects observed.
-------------------------------
870.3700                        Prenatal           Maternal NOAEL = 20
                                 developmental in   mg/kg/day.
                                 rabbits           Maternal LOAEL= 60 mg/
                                                    kg/day based on
                                                    mortality.
                                                   Developmental = 60 mg/
                                                    kg/day.
                                                   Developmental LOAEL =
                                                    150 mg/kg/day based
                                                    on increased
                                                    incidence of
                                                    abortion.
-------------------------------
870.3800                        Reproduction and   Parental NOAEL =
                                 fertility          1,000 ppm (70.8-82.3
                                 effects            mg/kg/day (M); 80.1-
                                                    91.2 (F).
                                                   Parental LOAEL =
                                                    10,000 ppm (721-844
                                                    and 813-901 mg/kg/
                                                    day) based on
                                                    decreased body
                                                    weight (bwt) and bwt
                                                    gains of F0 and
                                                    F1(M) and F1(F),
                                                    gross and
                                                    microscopic liver
                                                    lesions of (M) and
                                                    (F)-both
                                                    generations.
                                                   Reproductive NOAEL >=
                                                    10,000 ppm (721-844
                                                    and 813-901 mg/kg/
                                                    day).
                                                   Reproductive LOAEL
                                                    not determined; no
                                                    effects observed.
                                                   Offspring NOAEL =
                                                    1,000 ppm (70.8-82.3
                                                    mg/kg/day (M); 80.1-
                                                    91.2 (F).
                                                   Offspring LOAEL =
                                                    10,000 ppm (721-844
                                                    and 813-901 mg/kg/
                                                    day) based on
                                                    decreased bwt and
                                                    bwt gains of the F1
                                                    and F2 pups.
-------------------------------
870.4100                        Chronic toxicity   NOAEL >= 1,000 mg/kg/
                                 in dogs            day.
                                                   LOAEL not determined;
                                                    no effects observed.
-------------------------------
870.4200                        Carcinogenicity    NOAEL = 200 ppm
                                 in mice            (20.99 mg/kg/day
                                                    (M); 19.58 mg/kg/day
                                                    (F).
                                                   LOAEL = 1,000 ppm
                                                    (109.7 mg/kg/day
                                                    (M); 98.3 mg/kg/day
                                                    (F) based on liver
                                                    toxicity,
                                                    hepatocellular
                                                    tumors at 5,000 ppm;
                                                    possibly hemangioma/
                                                    hemangioasarcomas.
-------------------------------
870.4300                        Chronic toxicity   NOAEL = 2,000 ppm
                                 in rodents/        (86.7 mg/kg/day (M);
                                 carcinogenicity    111.5 mg/kg/day (F).
                                 in rats           LOAEL = 10,000 ppm
                                                    (468.1 mg/kg/day
                                                    (M); 578.5 mg/kg/day
                                                    (F) based on
                                                    decreased bwt and
                                                    bwt gain in males
                                                    and microcytic
                                                    anemia, liver
                                                    lesions and kidney
                                                    toxicity (both
                                                    sexes); possible
                                                    increase
                                                    pheochromocytomas in
                                                    females.
-------------------------------
870.5100                        Gene nutation      Non-mutagenic when
                                                    tested up to 5,000
                                                    [mu]g/plate, in
                                                    presence and absence
                                                    of metabolic
                                                    activation (S9-mix),
                                                    in S. typhimurium
                                                    strains TA98, TA100,
                                                    TA1535, TA1537 and
                                                    TA1538 and E.coli
                                                    strain WP2(uvrA).
                                                    There was no
                                                    evidence of induced
                                                    mutant colonies over
                                                    background.
-------------------------------

[[Page 27732]]

 
870.5300                        Gene mutation      In mammalian cell
                                                    gene mutation assays
                                                    at the TK locus,
                                                    L5178Y mouse
                                                    lymphoma cells
                                                    cultured in vitro
                                                    were exposed to
                                                    pyraflufen-ethyl in
                                                    dimethylsulfoxide
                                                    (DMOS) in the
                                                    absence of mammalian
                                                    metabolic activation
                                                    (S9-mix) and with S9-
                                                    mix. Concentrations
                                                    160 [mu]g/mL were
                                                    insoluble;
                                                    cytotoxicity was
                                                    seen at 80 [mu]g/mL
                                                    S9 and 160 [mu]g/mL
                                                    +S9. There was no
                                                    increase in the
                                                    number of mutant
                                                    colonies over
                                                    background in the
                                                    absence of S9-mix
                                                    but a non-
                                                    reproducible dose-
                                                    related increase in
                                                    the number of mutant
                                                    colonies was seen in
                                                    the presence of S9-
                                                    mix.
                                                   In mammalian cell
                                                    gene mutation assays
                                                    at the TK locus,
                                                    L5178Y mouse
                                                    lymphoma cells
                                                    cultured in vitro
                                                    were exposed to
                                                    pyraflufen-ethyl in
                                                    DMSO in the absence
                                                    of mammalian
                                                    metabolic activation
                                                    (S9-mix) and with S9-
                                                    mix. There was no
                                                    evidence of induced
                                                    mutant colonies over
                                                    background up to
                                                    cytotoxic
                                                    concentrations (50
                                                    [mu]g/mL-S9; and 350
                                                    [mu]g/mL +S9.
-------------------------------
870.5375                        Chromosomal        In a mammalian cell
                                 aberration         cytogenetics assay,
                                                    human primary
                                                    lymphocyte cultures
                                                    were exposed to
                                                    pyraflufen-ethyl in
                                                    DMSO without
                                                    metabolic activation
                                                    (S9-mix) or with S9-
                                                    mix. Compound
                                                    precipitation
                                                    occurred at 2,600
                                                    [mu]g/mL +/-S9.
                                                    There was no
                                                    evidence of
                                                    chromosomal
                                                    aberration induction
                                                    over background.
-------------------------------
870.5395                        Cytogenetics       In a CD-1 mouse bone
                                                    marrow micronucleus
                                                    assay, five mice/sex/
                                                    dose/harvest time
                                                    were treated via
                                                    oral gavage with
                                                    pyraflufen-ethyl in
                                                    corn oil. ET-751 was
                                                    tested to the limit
                                                    (LTD) dose of 5,000
                                                    mg/kg bwt. Signs of
                                                    compound toxicity
                                                    were limited to
                                                    piloerection,
                                                    hunched posture in
                                                    one female, and
                                                    piloerection and
                                                    hunched posture in
                                                    one male receiving
                                                    5,000 mg/kg. No bone
                                                    marrow cytotoxicity
                                                    was seen at any
                                                    dose. There was no
                                                    statistically
                                                    significant increase
                                                    in the frequency of
                                                    micronucleated
                                                    polychromatic
                                                    erythrocytes in bone
                                                    marrow after any
                                                    dose or treatment
                                                    time.
-------------------------------
870.5500                        Bacillus subtilis  In a differential
                                                    killing/growth
                                                    inhibition assay in
                                                    bacteria, strains
                                                    H17 (rec+) and M45
                                                    (rec-) of B.
                                                    subtilis were
                                                    exposed to
                                                    pyraflufen-ethyl in
                                                    DMSO in the presence
                                                    and absence of
                                                    metabolic activation
                                                    (S9-mix). There was
                                                    no evidence of
                                                    greater growth
                                                    inhibition or cell
                                                    killing in repair-
                                                    defective strains
                                                    compared to repair
                                                    competent strains up
                                                    to the limit of test
                                                    material solubility.
-------------------------------
870.5550                        Unscheduled DNA    In an in vivo/in
                                 synthesis (UDS)    vitro UDS assay in
                                                    rat hepatocytes,
                                                    pyraflufen-ethyl was
                                                    administered to five
                                                    SPF outbred albino
                                                    Hsd/Ola Sprague-
                                                    Dawley male rats per
                                                    test group by oral
                                                    gavage (four of the
                                                    five rats were used
                                                    for hepatocyte
                                                    culture). No signs
                                                    of overt toxicity to
                                                    the test animals or
                                                    cytotoxic effects to
                                                    the target cells
                                                    were seen up to the
                                                    LTD (2,000 mg/kg).
                                                    The mean net nuclear
                                                    grain count was
                                                    below zero for both
                                                    doses at both
                                                    treatment times
                                                    indicating no
                                                    induction of UDS as
                                                    tested in this
                                                    study.
-------------------------------

[[Page 27733]]

 
870.7485                        Metabolism and     Pyraflufen-ethyl was
                                 pharmaco-          readily absorbed and
                                 kinetics           excreted within 96
                                                    hours following a
                                                    single or repeated
                                                    oral dose of 5 mg/kg
                                                    (plasma t1/2 of 3-
                                                    3.5 hours). However,
                                                    at a dose of 500 mg/
                                                    kg, absorption was
                                                    saturated as
                                                    indicated by Cmax
                                                    values which did not
                                                    reflect the 100-fold
                                                    dose differential
                                                    (2.7-2.8 Fg eq/g for
                                                    the low-dose group
                                                    and 100-107 Fg eq-hr/
                                                    g for the high-dose
                                                    group). Following
                                                    single or multiple
                                                    oral low doses (5 mg/
                                                    kg) of pyraflufen
                                                    ethyl, urinary
                                                    excretion accounted
                                                    for 27-33% of the
                                                    administered
                                                    radioactivity
                                                    suggesting that a
                                                    multiple exposure
                                                    regimen did not
                                                    affect the
                                                    absorption/excretion
                                                    processes. Urinary
                                                    excretion was
                                                    reduced to only 5-7%
                                                    following a single
                                                    500 mg/kg dose.
                                                    Excretion via the
                                                    feces accounted for
                                                    the remainder of the
                                                    administered
                                                    radioactivity in all
                                                    treatment groups.
                                                    Analysis of biliary
                                                    excretion following
                                                    a single 5 mg/kg
                                                    dose showed that 36%
                                                    of the administered
                                                    dose appeared in the
                                                    bile. Based upon the
                                                    excretion data,
                                                    total
                                                    bioavailability of a
                                                    low dose was
                                                    approximately 56%.
                                                    Biliary excretion
                                                    data were not
                                                    available for a high-
                                                    dose group which
                                                    prevented a
                                                    definitive
                                                    assessment of
                                                    bioavailability.
                                                    Excretory patterns
                                                    did not exhibit
                                                    gender-related
                                                    variability.
                                                    However, plasma and
                                                    blood clearance was
                                                    more rapid in
                                                    females than in
                                                    males as shown by
                                                    plasma/blood
                                                    radioactivity time-
                                                    course and the
                                                    greater AUC values
                                                    for males (32.3 vs
                                                    18.4 Fg eq-hr/g for
                                                    the low-dose group
                                                    and 2,738 vs 1,401
                                                    Fg eq-hr/g for the
                                                    high-dose group).
                                                    Radioactivity
                                                    concentrations
                                                    indicated tissue
                                                    concentrations at or
                                                    near detection
                                                    limits (generally
                                                    <0.01 Fg eq/g and
                                                    never exceeding 0.02
                                                    Fg eq/g) at 96 hrs
                                                    postdose for any
                                                    tissues. Therefore,
                                                    neither pyraflufen-
                                                    ethyl nor its
                                                    metabolites appear
                                                    to undergo
                                                    significant
                                                    sequestration.
                                                    Tissue burden data
                                                    following compound
                                                    administration did
                                                    not suggest a
                                                    specific target
                                                    beyond those
                                                    tissues, namely
                                                    liver and kidney,
                                                    which are associated
                                                    with absorption and
                                                    elimination of
                                                    orally administered
                                                    xenobiotics.
------------------------------------------------------------------------

B. Toxicological Endpoints

    The dose at which no observed adverse effects levels are (the 
NOAEL) from the toxicology study identified as appropriate for use in 
risk assessment is used to estimate the toxicological level of concern 
(LOC). However, the lowest dose at which observed adverse effects of 
levels concern are identified (the LOAEL) is sometimes used for risk 
assessment if no NOAEL was achieved in the toxicology study selected. 
An uncertainty factor (UF) is applied to reflect uncertainties inherent 
in the extrapolation from laboratory animal data to humans and in the 
variations in sensitivity among members of the human population as well 
as other unknowns. An UF of 100 is routinely used, 10X to account for 
interspecies differences and 10X for intraspecies differences.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (aRfD or cRfD) where 
the RfD is equal to the NOAEL divided by the appropriate UF (RfD = 
NOAEL/UF). Where an additional safety factor (SF) is retained due to 
concerns unique to the FQPA, this additional factor is applied to the 
RfD by dividing the RfD by such additional factor. The acute or chronic 
Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to 
accommodate this type of FQPA SF.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the LOC. For example, when 100 is the appropriate UF (10X 
to account for interspecies differences and 10X for intraspecies 
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to 
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and 
compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk is expressed as 1 x 10-6 or one in a million). 
Under certain specific circumstances, MOE calculations will be used for 
the carcinogenic risk assessment. In this non-linear approach, a 
``point of departure'' is identified below which carcinogenic effects 
are not expected. The point of departure is typically a NOAEL based on 
an endpoint related to cancer effects though it may be a different 
value derived from the dose response curve. To estimate risk, a ratio 
of the point of departure to exposure (MOEcancer = point of 
departure/exposures) is calculated. A summary of the toxicological 
endpoints for pyraflufen-ethyl used for human risk assessment is shown 
in Table 2:

[[Page 27734]]



   Table 2.--Summary of Toxicological Dose and Endpoints for pyraflufen-ethyl for use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                  Hazard Based Special      Endpoint for Risk
          Exposure Scenario            Dose (mg/kg/day) UF/MOE     FQPA Safety Factor           Assessment
----------------------------------------------------------------------------------------------------------------
                                            Dietary Risk Assessments
----------------------------------------------------------------------------------------------------------------
Acute dietary                          Not applicable           Not applicable           No adverse effect
                                                                                          attributable to a
                                                                                          single exposure (dose)
                                                                                          was observed in oral
                                                                                          toxicity studies,
                                                                                          including the
                                                                                          developmental toxicity
                                                                                          studies in rats and
                                                                                          rabbits.
--------------------------------------
Chronic dietary                        NOAEL= 20                1X                       Mouse carcinogenicity.
                                       UF = 100...............                           LOAEL = 98 mg/kg/day
                                       Chronic RfD = 0.20 mg/                             based on liver
                                        kg/day.                                           toxicity.
--------------------------------------
Incidental oral short-term (1-30       NOAEL= 20                1X                       Developmental toxicity-
 days) residential only                UF = 100...............                            rabbit.
                                       MOE=100................                           LOAEL = 60 mg/kg/day
                                                                                          based on decreases in
                                                                                          body weight and food
                                                                                          consumption, GI
                                                                                          observations, and
                                                                                          abortions.
--------------------------------------
Incidental oral intermediate-term (1-  NOAEL= 20                1X                       Mouse carcinogenicity.
 6 months) residential only            UF = 100...............                           LOAEL = 98 mg/kg/day
                                       MOE=100................                            based on liver
                                                                                          toxicity at interim
                                                                                          sacrifice.
--------------------------------------
                                          Non-Dietary Risk Assessments
----------------------------------------------------------------------------------------------------------------
Dermal short-term and intermediate-    Not applicable           Not applicable           In a 28-dermal toxicity
 term                                                                                     study in rats, no
                                                                                          dermal or systemic
                                                                                          toxicity was seen at
                                                                                          the LTD (1,000 mg/kg/
                                                                                          day). The physical and
                                                                                          chemical
                                                                                          characteristics (e.g.,
                                                                                          Kow is low) indicate
                                                                                          that dermal absorption
                                                                                          is not expected to
                                                                                          occur to any
                                                                                          appreciable extent.
                                                                                          There is no concern
                                                                                          for prenatal and/or
                                                                                          postnatal toxicity.
                                                                                          Therefore, no hazard
                                                                                          was identified and
                                                                                          quantification of
                                                                                          dermal risk is not
                                                                                          required.
--------------------------------------
Residential                            MOE = not applicable     Not applicable
--------------------------------------
Occupational                           MOE = not applicable     Not applicable
--------------------------------------
Inhalation1 short-term (1-30 days)     Oral NOAEL= 20           1X                       Developmental toxicity-
                                                                                          rabbit.
                                                                                         LOAEL = 60 mg/kg/day
                                                                                          based on decreases in
                                                                                          bwt and food
                                                                                          consumption, GI
                                                                                          observations, and
                                                                                          abortions.
--------------------------------------
Residential                            MOE = 100
--------------------------------------
Occupational                           MOE= 100
--------------------------------------
Inhalation1 intermediate-term (1-6     Oral NOAEL= 20           1X                       Mouse carcinogenicity.
 months)                                                                                 LOAEL = 98 mg/kg/day
                                                                                          based on liver
                                                                                          toxicity at interim
                                                                                          sacrifice.
--------------------------------------
Residential                            MOE = 100
--------------------------------------
Occupational                           MOE= 100
--------------------------------------
Inhalation1 long-term (< 6 months)     Oral NOAEL= 20           1X                       Mouse carcinogenicity.
                                                                                         LOAEL = 98 mg/kg/day
                                                                                          based on liver
                                                                                          toxicity.
--------------------------------------
Residential                            MOE =100
--------------------------------------
Occupational                           MOE= 100
--------------------------------------
Cancer                                 Classification: ``Likely to be Carcinogenic to Humans'' by the oral route
                                                             Q1* = 3.32 x 10-2 (mg/kg/day)-1
----------------------------------------------------------------------------------------------------------------
1-Oral endpoints were selected because inhalation studies were unavailable. Absorption via the inhalation route
  is presumed to be equivalent to oral absorption.
* The reference to the FQPA SF refers to any additional SF retained due to concerns unique to the FQPA.


[[Page 27735]]

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.585) for the combined residues of pyraflufen-
ethyl (ethyl 2-chloro-5-(4-chloro-5-difluoromethoxy-1-methyl-1H-
pyrazol-3-yl)-4-fluorophenoxyacetate) and its acid metabolite, E-1 (2-
chloro-5-(4-chloro-5-difluoromethoxy-1-methyl-1H-pyrazol-3-yl)-4-
fluorophenoxyacetic acid), expressed as the ester equivalent in or on a 
variety of raw agricultural commodities. Risk assessments were 
conducted by EPA to assess dietary exposures from pyraflufen-ethyl in 
food as follows:
    i. Acute exposure. Acute dietary risk assessments are performed for 
a food-use pesticide if a toxicological study has indicated the 
possibility of an effect of concern occurring as a result of a 1-day or 
single exposure. No adverse effect attributable to a single exposure 
(dose) of pyraflufen-ethyl was observed in the oral toxicity studies, 
including the developmental toxicity studies in rats and rabbits. 
Therefore, EPA did not identify an acute dietary endpoint and an acute 
dietary assessment was not performed because no acute risk is expected.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the Dietary Exposure Evaluation Model (DEEMTM) 
analysis evaluated the individual food consumption as reported by 
respondents in the United State Department of Agriculture (USDA) 
nationwide Continuing Surveys of Food Intake by Individuals (CSFII) 
1989-1992 and accumulated exposure to the chemical for each commodity. 
The following assumptions were made for the chronic exposure 
assessments: 100% crop treated (PCT) and tolerance-level residues for 
pyraflufen-ethyl on all treated crops. This assessment was Tier I 
analysis. The exposure from pyraflufen-ethyl residues in food occupies 
less than 1% of the chronic population adjusted dose (cPAD) for all 
population subgroups and is not a concern.
    iii. Cancer. The cancer dietary exposure assessment was conducted 
using the DEEM analysis evaluated the individual food consumption as 
reported by respondents in the USDA nationwide CSFII 1989-1992 and 
accumulated exposure to the chemical for each commodity. The following 
assumptions were made for the cancer assessments: 100% PCT and 
tolerance-level residues for pyraflufen-ethyl on all treated crops. The 
estimated exposure to the U.S. population (total) to pyraflufen-ethyl 
is 2 x 10-5 mg/kg/day. Applying the Q1* of 0.0332 
(mg/kg/day)-1 to the exposure value results in a cancer risk 
estimate of 6.6 x 10-7. Therefore, the lifetime cancer risk 
to the U.S. population is below EPA's level of concern.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for pyraflufen-ethyl 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 chemical and 
physical characteristics of pyraflufen-ethyl.
    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 
1 model) before using PRZM/EXAMS (a tier 2 model). The FIRST model is a 
subset of the PRZM/EXAMS model that uses a specific high-end runoff 
scenario for pesticides. While both FIRST and PRZM/EXAMS incorporate an 
index reservoir environment, the PRZM/EXAMS model includes a PCT crop 
area factor as an adjustment to account for the maximum PCT crop 
coverage within a watershed or drainage basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a coarse screen for sorting out pesticides for 
which it is highly unlikely that drinking water concentrations would 
ever exceed human health levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs) from these models to quantify 
drinking water exposure and risk as a percent referance dose (%RfD) or 
percent population adjusted dose (%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 pyraflufen-ethyl they are further discussed in the 
aggregate risk sections below.
    Based on the FIRST and SCI-GROW models the EECs of pyraflufen-ethyl 
for acute exposures are estimated to be 1.25 parts per billion (ppb) 
for surface water and 0.002 ppb for ground water. The EECs for chronic 
exposures are estimated to be 0.28 ppb for surface water and 0.002 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).
    Pyraflufen-ethyl is currently registered for use on the following 
residential non-dietary sites: Airports, nurseries, ornamental turf, 
golf courses, roadsides, and railroads. The risk assessment was 
conducted using the following residential exposure assumptions: adults 
and children may be exposed to residues of pyraflufen-ethyl through 
postapplication contact with treated areas which may include 
residential/recreational areas.
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether pyraflufen-ethyl has a common mechanism of toxicity with other 
substances or how to include this pesticide in a cumulative risk 
assessment. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, 
pyraflufen-ethyl 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 pyraflufen-ethyl has a common 
mechanism of toxicity with other substances. For information regarding 
EPA's efforts to determine which chemicals have a common mechanism of 
toxicity and to evaluate the cumulative effects of such chemicals, see 
the final rule for

[[Page 27736]]

Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

D. Safety Factor for Infants and Children

    1. In general. Section 408 of the FFDCA provides that EPA shall 
apply an additional tenfold margin of safety (MOS) for infants and 
children in the case of threshold effects to account for prenatal and 
postnatal toxicity and the completeness of the database on toxicity and 
exposure unless EPA determines that a different MOS will be safe for 
infants and children. MOS are incorporated into EPA risk assessments 
either directly through use of a MOE analysis or through using 
uncertainty (safety) factors in calculating a dose level that poses no 
appreciable risk to humans.
    2. Prenatal and postnatal sensitivity. There is no evidence of 
increased susceptibility of rat or rabbit fetuses following in utero 
exposure in the developmental studies with pyraflufen-ethyl. There is 
no evidence of increased susceptibility of young rats in the 
reproduction study with pyraflufen-ethyl. EPA concluded there are no 
residual uncertainties for prenatal and/or postnatal exposure.
    3. Conclusion. There is a complete toxicity database for 
pyraflufen-ethyl and exposure data are complete or are estimated based 
on data that reasonably accounts for potential exposures. The field 
trial data on cotton, while some of which may be limited in geographic 
representation or lack of early season application, indicate that 
residues of pyraflufen-ethyl are expected to be finite. EPA determined 
that the 10X SF to protect infants and children should be removed and 
instead, a different additional safety factor of 1X should be used. The 
FQPA factor is removed because: There is no evidence of increased 
susceptibility of rat or rabbit fetuses following in utero exposure in 
the developmental studies with pyraflufen-ethyl; there is no evidence 
of increased susceptibility of young rats in the reproduction study 
with pyraflufen-ethyl; there are no residual uncertainties identified 
in the exposure databases; the dietary food exposure assessment is 
expected to be conservative, tolerance-level residues and 100% crop 
treated information were used; and dietary drinking water exposure is 
based on conservative modeling estimates.

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 bwts. Default bwts and consumption values as used by 
the United States Environmental Protection Agency Office of Water are 
used to calculate DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg 
(adult female), and 1L/10 kg (child). Default bwts 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 adverse effect attributable to a single exposure 
(dose) of pyraflufen-ethyl was observed in the oral toxicity studies, 
including the developmental toxicity studies in rats and rabbits. 
Therefore, an acute RfD was not established and no acute risk is 
expected.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
pyraflufen-ethyl from food will utilize <1% of the cPAD for the U.S. 
population and <1% of the cPAD for children (1-6 years). Based on the 
use pattern, chronic residential exposure to residues of pyraflufen-
ethyl is not expected. In addition, there is potential for chronic 
dietary exposure to pyraflufen-ethyl in drinking water. After 
calculating DWLOCs and comparing them to the EECs for surface and 
ground water, EPA does not expect the aggregate exposure to exceed 100% 
of the cPAD, as shown in the following Table 3:

           Table 3.--Aggregate Risk Assessment for Chronic (Non- Cancer) Exposure to Pyraflufen-ethyl
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground      Chronic
              Population Subgroup1               cPAD mg/kg/     % cPAD     Water EEC    Water EEC      DWLOC
                                                     day         (Food)       (ppb)2       (ppb)2       (ppb)3
----------------------------------------------------------------------------------------------------------------
U.S population                                          0.20           <1         0.28        0.002        7,000
------------------------------------------------
Males (20+ years old)                                   0.20           <1         0.28        0.002        7,000
------------------------------------------------
Females (13-50 years old)                               0.20           <1         0.28        0.002        6,000
------------------------------------------------
Children (1-6 years old)                                0.20           <1         0.28        0.002        2,000
------------------------------------------------
Males (13-19 years old)                                 0.20           <1         0.28        0.002        7,000
----------------------------------------------------------------------------------------------------------------
1 Subgroups with the highest food-source dietary exposure were selected for adult males, adult females and
  children. The following bwts were used (70 kg adult male; 60 kg adult females; 10 kg child).
2 The crop producing the highest level was used (potatoes, 0.009 lb active ingredient/acre).
3 Chronic DWLOC (ppb) = [maximum chronic water exposure (mg/kg/day) x bwt (kg)] / [water consumption (L) x 10-3
  mg/kg]).


[[Page 27737]]

    3. Short-term risk. The short-term aggregate risk assessment 
estimates risks likely to result from 1-30 days exposure to pyraflufen-
ethyl residues from food, drinking water, and residential pesticide 
uses. High-end estimates of residential exposure are used in the short-
term aggregate assessment, while average (chronic) values are used to 
account for dietary (food only) exposure. The short-term aggregate risk 
assessment is considered conservative because food-source dietary 
exposure is based on a Tier 1 DEEM assessment (tolerance level residues 
and 100% crop treated information were used).
    A short-term aggregate risk assessment is not performed for adults 
because no handler exposure is expected and postapplication inhalation 
exposure is expected to be negligible. A short-term aggregate risk 
assessment is required for infants and children because there is a 
potential for oral post-application exposure resulting from residential 
uses.
    Pyraflufen-ethyl is currently registered for use that could result 
in short-term residential exposure and the Agency has determined that 
it is appropriate to aggregate chronic food and water and short-term 
exposures for pyraflufen-ethyl.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food and residential exposures 
aggregated result in aggregate MOEs of 170,000 for children (1-6 years 
old). These aggregate MOEs do not exceed the Agency's level of concern 
for aggregate exposure to food and residential uses. In addition, 
short-term DWLOCs were calculated and compared to the EECs for chronic 
exposure of pyraflufen-ethyl in ground and surface water. After 
calculating DWLOCs and comparing them to the EECs for surface and 
ground water, EPA does not expect short-term aggregate exposure to 
exceed the Agency's level of concern, as shown in Table 4:

                 Table 4.--Aggregate Risk Assessment for Short-Term Exposure to Pyraflufen-ethyl
----------------------------------------------------------------------------------------------------------------
                                                               Aggregate
                                               Aggregate MOE    Level of     Surface       Ground     Short-Term
             Population Subgroup                  (Food +       Concern     Water EEC    Water EEC      DWLOC
                                               Residential)1     (LOC)        (ppb)2       (ppb)2       (ppb)3
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old)                            170,000           100         0.28        0.002        2,000
----------------------------------------------------------------------------------------------------------------
1 Aggregate MOE = NOAEL (Avg Food Exposure + Residential Exposure).
2 The crop producing the highest level was used (potatoes, 0.009 lb ai/acre).
3DWLOC(ppb) = [maximum water exposure (mg/kg/day) x bwt (kg)] / [water consumption (L) x 10-3 mg/kg]
*(bwt: Children-10 kg).

    4. Intermediate-term risk. The intermediate-term aggregate risk 
assessment estimates risks likely to result from 1-6 months of exposure 
to pyraflufen-ethyl residues from food, drinking water, and residential 
pesticide uses. High-end estimates of residential exposure are used in 
the intermediate-term assessment, while average values are used for 
food and drinking water exposure.
    An intermediate-term aggregate risk assessment is not preformed for 
adults because no handler exposure is expected and postapplication 
inhalation exposure is expected to be negligible. Also, an 
intermediate-term aggregate risk assessment is not preformed for 
infants and children because postapplication exposure over the 
intermediate-term duration is not likely based on the use pattern.
    5. Aggregate cancer risk for U.S. population. Pyraflufen-ethyl has 
been classified as a ``Likely to be Carcinogenic to Humans'' by the 
oral route of exposure (Q1* of 3.32 x 10-2 (mg/
kg/day)-1). Using the exposure assumptions discussed in this 
unit for cancer, the cancinogenic risk is determined for the U.S. 
population (total) only. The aggregate cancer DWLOC (2.3 ppb) is 
greater than EPA's estimates of pyraflufen-ethyl residues in drinking 
water. Therefore, the aggregate cancer risk from residues of 
pyraflufen-ethyl in food and drinking water does not exceed EPA's level 
of concern as shown in the following Table 5:

                           Table 5.--Cancer DWLOC Calculations for the U.S. Population
----------------------------------------------------------------------------------------------------------------
                                                               Aggregate
                                                  Negligible  cancer risk     Ground      Surface       Cancer
                Q1* mg/kg/day)-1                 Risk Level1   (food and    Water EEC2   Water EEC2     DWLOC3
                                                              residential     (ppb)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
0.0332                                                3.0E-6       8.3E-7        0.002         0.28          2.3
----------------------------------------------------------------------------------------------------------------
1 Negligible risk is that below 10-6. 3.0E-6 is statistically within the range that EPA generally accepts as
  ``negligible risk''.
2 The crop producing the highest level was used (potatoes).
3Cancer DWLOC (ppb) = [maximum water exposure (mg/kg/day) x bwt (kg)] / [water consumption (L) x 10-3 mg/kg]

    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 pyraflufen-ethyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Nichino America, Inc. has submitted a petition method validation 
(PMV) and an independent laboratory validation for a Gas 
Chromatography/Mass Spectometry (GC/MS) method proposed for the 
enforcement of tolerances for residues of pyraflufen ethyl and its acid 
metabolite, E-1. The proposed plant method is adequate for enforcement 
of tolerances in/on cotton.
    Adequate enforcement methodology (example--GC) is available to 
enforce the tolerance expression. The method may be requested from: 
Chief, Analytical Chemistry Branch, Environmental Science Center, 701 
Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; 
e-mail address: [email protected].

[[Page 27738]]

B. International Residue Limits

    There is neither a Codex proposal, nor Canadian or Mexican limits, 
for residues of pyraflufen-ethyl in/on cotton. Harmonization is not an 
issue for this petition.

C. Conditions

    A risk assessment for human health has been conducted for this 
proposed use. Using the proposed or recommended tolerances, the chronic 
estimates are well below the Agency's level of concern and the cancer 
risk estimate is also within Agency's level of concern. The following 
data are being required by the Agency to complete the database 
requirements prior to approval of an unconditional registration of 
pyraflufen-ethyl on cotton:
    [sbull] Product label contain a statement limiting use to 
commercial applicators only so that possible use by homeowners on 
residential turf would be minimized and/or include a restriction 
prohibiting use by homeowners for the turf and ornamental use sites.
    [sbull] Proposed uses in farmyards, farm buildings, fence lines, 
dry ditches and ditch banks be removed from the label due to the 
potential for residues to contact food sources in these use sites.
    [sbull] The label for pyraflufen ethyl should clearly state the 
allowable number of applications per season.

V. Conclusion

    Therefore, tolerances are established for combined residues of 
pyraflufen-ethyl (ethyl 2-chloro-5-(4-chloro-5-difluoromethoxy-1-
methyl-1H-pyrazol-3-yl)-4-fluorophenoxyacetate) and its acid 
metabolite, E-1 (2-chloro-5-(4-chloro-5-difluoromethoxy-1-methyl-1H-
pyrazol-3-yl)-4-fluorophenoxyacetic acid), expressed pyraflufen-ethyl 
in or on cotton undelinted seed at 0.04 ppm and cotton gin byproduct at 
1.5 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.

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-2003-0163 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 July 21, 
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-2003-0163, 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

[[Page 27739]]

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 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: May 7, 2003.
Debra Edwards,
Director, Registration Division, 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 180.585 is amended by alphabetically adding commodities in 
the table in paragraph (a) to read as follows:


Sec.  180.585  Pyraflufen-ethyl; tolerances for residues.

    (a) * * *

----------------------------------------------------------------------------------------------------------------
                            Commodity                                            Parts per million
----------------------------------------------------------------------------------------------------------------
Cotton, gin byproduct............................................                                            1.5
Cotton, undelinted seed..........................................                                           0.04
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[[Page 27740]]

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[FR Doc. 03-12359 Filed 5-20-03; 8:45 am]
BILLING CODE 6560-50-S