Pyraflufen-ethyl (Nichino America). April 30, 2003. Pesticide tolerances. Final Rule. Federal Register.

FLUORIDE ACTION NETWORK PESTICIDE PROJECT

Pyraflufen-ethyl (Nichino America). April 30, 2003.
Pesticide Tolerance. Final Rule. Federal Register.

http://www.epa.gov/fedrgstr/EPA-PEST/2003/April/Day-30/p10264.htm

[Federal Register: April 30, 2003 (Volume 68, Number 83)]
[Rules and Regulations]
[Page 23046-23056]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30ap03-8]

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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:
miller.joanne@epa.gov.

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:
¥ Crop production (NAICS Code 111)
¥ Animal production (NAICS Code 112)
¥ Food manufacturing (NAICS Code 311)
¥ 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_40/40cfr180_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

[[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.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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 t_1/2 of 3-
3.5 hours). However, at a dose of 500 mg/kg,
absorption was saturated as indicated by C_max
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: residuemethods@epa.gov.
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 tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.1. Mail your
copies, identified by docket ID number OPP-2003-0110, 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: opp-docket@epa.gov. Please use an ASCII
file format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 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 (59 FR 22951, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.

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.

¥ Therefore, 40 CFR chapter I is amended as follows:

PART 180-- [AMENDED]

¥ 1. The authority citation for part 180 continues to read as follows:

Authority: 21 U.S.C. 321(q), 346(a) and 371.

¥ 2. Section 180.585 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