[Federal Register Volume 68, Number 83 (Wednesday, April 30, 2003)]
[Rules and Regulations]
[Pages 23046-23056]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-10264]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0110; FRL-7300-9]


Pyraflufen-ethyl; Pesticide Tolerance

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Final rule.

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SUMMARY:  This regulation establishes a tolerance for combined residues 
of pyraflufen-ethyl in or on field corn, potato, and soybean. Nichino 
America Incorporated requested these tolerances 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 April 30, 2003. Objections and 
requests for hearings, identified by docket ID number OPP-2003-0110, 
must be received on or before June 30, 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, 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 Code 111)
    [sbull] Animal production (NAICS Code 112)
    [sbull] Food manufacturing (NAICS Code 311)
    [sbull] Pesticide manufacturing (NAICS Code 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-2003-0110. 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_40/4 0cfr180--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

[[Page 23047]]

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 field corn forage, field corn grain, and field corn 
stover at 0.01 parts per million (ppm); potato at 0.02 ppm; and soybean 
forage, soybean hay, and soybean seed at 0.01.
    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 field corn forage, field corn grain, and field corn stover at 0.01 
ppm; potato at 0.02 ppm; and soybean forage, soybean hay, and soybean 
seed at 0.01. 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.

                                Table 1.--Subchronic, Chronic, and Other Toxicity
----------------------------------------------------------------------------------------------------------------
            Guideline No.                     Study Type                             Results
----------------------------------------------------------------------------------------------------------------
870.3100                               90-Day oral toxicity in  NOAEL = 5,000 ppm (456-499 milligram/kiligram/
                                        rats                     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.
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870.3150                               90-Day oral toxicity in  NOAEL = 1,000 mg/kg/day.
                                        dogs                    LOAEL not established; no effects observed.
----------------------------------------------------------------------------------------------------------------
870.3200                               28-Day dermal toxicity   NOAEL = 1,000 mg/kg/day.
                                        in rats                 LOAEL not established; no effects observed.
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870.3700                               Prenatal developmental   Maternal NOAEL >=1,000 mg/kg/day.
                                        in 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 developmental   Maternal NOAEL = 20 mg/kg/day.
                                        in 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.
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870.3800                               Reproduction and         Parental NOAEL = 1,000 ppm (70.8-82.3 mg/kg/day
                                        fertility effects        (M); 80.1-91.2 mg/kg/day (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.
----------------------------------------------------------------------------------------------------------------

[[Page 23048]]

 
870.4100                               Chronic toxicity in      NOAEL >1,000 mg/kg/day.
                                        dogs                    LOAEL not determined; no effects observed.
----------------------------------------------------------------------------------------------------------------
870.4200                               Carcino-genicity in      NOAEL = 200 ppm (20.99 mg/kg/day (M); 19.58 mg/
                                        mice                     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 in      NOAEL = 2,000 ppm; 86.7 mg/kg/day (M); 111.5 mg/
                                        rodents/                 kg/day (F).
                                        carcinogenicity in      LOAEL = 10,000 ppm; 468.1 mg/kg/day (M); 578.5
                                        rats                     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 mutation            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, TA1538, and E.coli
                                                                 strain WP2(uvrA). There was no evidence of
                                                                 induced mutant colonies over background.
----------------------------------------------------------------------------------------------------------------
870.5300                               Gene mutation            1. In mammalian cell gene mutation assays at the
                                                                 TK locus, L5178Y mouse lymphoma cells cultured
                                                                 in vitro were exposed to pyraflufen-ethyl in
                                                                 dimethylsulfoxide (DMSO) 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.
                                                                2. In mammalian cell gene mutation assays at the
                                                                 TK locus, L5178Y mouse lymphoma cells cultured
                                                                 in vitro were exposed to pyraflufen-ethyl in
                                                                 dimethylsulfoxide (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 aberration   In a mammalian cell 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 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 Bacillus 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 vitro UDS assay in rat
                                        Synthesis (UDS)          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 limit dose (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 23049]]

 
870.7485                               Metabolism and pharmaco- Pyraflufen-ethyl was 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
                                                                 hours 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 the NOAEL from the toxicology study identified as 
appropriate for use in risk assessment is used to estimate the 
toxicological level of concern (LOC). However, the lowest dose at which 
adverse effects of concern are identified (the LOAEL) is sometimes used 
for risk assessment if no NOAEL was achieved in the toxicology study 
selected. An Uncertainty Factor (UF) is applied to reflect 
uncertainties inherent in the extrapolation from laboratory animal data 
to humans and in the variations in sensitivity among members of the 
human population as well as other unknowns. An UF of 100 is routinely 
used, 10X to account for interspecies differences and 10X for 
intraspecies differences.
    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 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 (MOE cancer = 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.

   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.
--------------------------------------

[[Page 23050]]

 
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)                                 UF = 100...............                            rabbit
Residential only.....................  MOE = 100..............                           LOAEL = 60 mg/kg/day
                                                                                          based on decreases in
                                                                                          bwt and food
                                                                                          consumption, GI
                                                                                          observations, and
                                                                                          abortions
----------------------------------------------------------------------------------------------------------------
Incidental oral intermediate-term (1-  NOAEL = 20               1X                       Mouse Carcinogenicity
 6 months)                             UF = 100...............                           LOAEL = 98 mg/kg/day
Residential only.....................  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 limit dose (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 toxicty
----------------------------------------------------------------------------------------
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.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established, 40 CFR part 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

[[Page 23051]]

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 U.S. Department of Agriculture (USDA) nationwide 
Continuing Surveys of Food Intake by Individuals (CSFII) 1994-1996 and 
1998, 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 percent 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 1994-1996 and 
1998, and accumulated exposure to the chemical for each commodity. The 
following assumptions were made for the cancer assessments: 100% crop 
treated 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 results in a cancer risk of 
10-6 and is not a 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 percent 
crop area factor as an adjustment to account for the maximum percent 
crop coverage within a watershed or drainage basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a coarse screen for sorting out pesticides for 
which it is highly unlikely that drinking water concentrations would 
ever exceed human health levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs) from these models to quantify 
drinking water exposure and risk as a percent reference dose (%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 
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 
post-application 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 Bifenthrin Pesticide Tolerances (62 FR 62961, 
November 26, 1997).

D. Safety Factor for Infants and Children

    1. In general. Section 408 of the FFDCA provides that EPA shall 
apply an additional tenfold margin of safety for infants and children 
in the case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
unless EPA determines that a different margin of safety will be safe 
for infants and children. Margins of safety are incorporated into EPA 
risk assessments either directly through use of a MOE analysis or 
through using uncertainty (safety) factors in calculating a dose

[[Page 23052]]

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 data base 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 potato, field corn and soybean, while some of which may 
be limited in geographic representation, indicate that residues of 
pyraflufen-ethyl are expected to be below the levels of quantitation. 
The likelihood of finite residues to occur in these crops is quite low. 
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 data bases; the dietary food 
exposure assessment is expected to be conservative, tolerance-level 
residues and 100 PCT 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. 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 U.S. EPA 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 (3-5 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
----------------------------------------------------------------------------------------------------------------
Adults (20-49 years)                                    0.20           <1         0.28        0.002        7,000
----------------------------------------------------------------------------------------------------------------
Females (13-49 years)                                   0.20           <1         0.28        0.002        6,000
----------------------------------------------------------------------------------------------------------------
Children (1-2 years)                                    0.20           <1         0.28        0.002        2,000
----------------------------------------------------------------------------------------------------------------
Children (3-5 years)                                    0.20           <1         0.28        0.002        2,000
----------------------------------------------------------------------------------------------------------------
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 (a.i./a)).
3 Chronic DWLOC (ppb) = [maximum chronic water exposure (mg/kg/day) x bwt (kg)] / [water consumption (L) x 10-3
  mg/[mu]g]

    3. Short-term risk. The short-term aggregate risk assessment 
estimates risks likely to result from 1 to 30 day 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)

[[Page 23053]]

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 risk aggregate assessment is not performed for adults 
because no handler exposure is expected and post-application 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 122,000 for children (1-2 years 
old) and 122,000 for children (3-5years 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 water and surface water. After calculating DWLOCs and comparing 
them to the EECs for surface water and ground water, EPA does not 
expect short-term aggregate exposure to exceed the Agency's level of 
concern, as shown in the following 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 (1-2 years)                                122,000           100         0.28        0.002        2,000
----------------------------------------------------------------------------------------------------------------
Children (3-5 years)                                122,000           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).
3 DWLOC (ppb) = [maximum water exposure (mg/kg/day) x bwt (kg)] / [water consumption (L) x 10-3 mg/[mu]g]
*(bwt: Children-10 kg)

    4. Intermediate-term risk. The intermediate-term aggregate risk 
assessment estimates risks likely to result from 1 to 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 risk aggregate assessment is not performed 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 performed 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 ``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 carcinogenic risk is determined for the U.S. 
population (total) only. The aggregate cancer DWLOC (1.6 ppb) is 
greater than EPA's estimates of pyraflufen-ethyl residues in drinking 
water. The estimated exposure to pyraflufen-ethyl is 4 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 10-6. 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
----------------------------------------------------------------------------------------------------------------
                                                                Chronic
                                                  Negligible      Food        Ground      Surface       Cancer
               Q1* (mg/kg/day)-1                 Risk Level1  Exposure mg/  Water EEC2   Water EEC2     DWLOC3
                                                                 kg/day       (ppb)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
0.0332                                                3.0E-6       4.0E-5        0.002         0.28          1.6
----------------------------------------------------------------------------------------------------------------
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). (3 Cancer DWLOC (ppb) = [maximum water exposure (mg/
  kg/day) x bwt (kg)] / [water consumption (L) x 10-3 mg/[mu]g].

    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 Spectrometry (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 field corn, potato, and soybean.
    Adequate enforcement methodology (example--gas chromotography) is 
available to enforce the tolerance expression. The method may be 
requested from: Chief, Analytical Chemistry Branch, Environmental

[[Page 23054]]

Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone 
number: (410) 305-2905; e-mail address: [email protected].

B. International Residue Limits

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

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 field corn forage, field corn grain, and field corn stover at 
0.01 ppm; potato at 0.02 ppm; and soybean forage, soybean hay, and 
soybean seed at 0.01.

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. 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-2003-0110 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 June 30, 
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-2003-0110, 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 part 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

[[Page 23055]]

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: April 16, 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 added to read as follows:


Sec.  180.585  Pyraflufen-ethyl; tolerances for residues.

    (a) General. Tolerances are established for 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), in or on the 
following raw agricultural commodities:

------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
Corn, field, forage............................                     0.01
Corn, field, grain.............................                     0.01
Corn, field, stover............................                     0.01
Potato.........................................                     0.02
Soybean, forage................................                     0.01
Soybean, hay...................................                     0.01
Soybean, seed..................................                     0.01
------------------------------------------------------------------------


[[Page 23056]]

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 03-10264 Filed 4-29-03; 8:45 am]
BILLING CODE 6560-50-S