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Pyraflufen-ethyl
(Nichino America). May 21, 2003.
Pesticide Tolerance. Final Rule. Federal Register.
http://www.epa.gov/fedrgstr/EPA-PEST/2003/May/Day-21/p12359.htm
[Federal Register: May 21, 2003 (Volume 68, Number 98)]
[Rules and Regulations]
[Page 27729-27740]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21my03-3]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2003-0163; FRL-7306-1]
Pyraflufen-ethyl; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a tolerance for combined residues
of pyraflufen-ethyl in or on cotton. Nichino America Incorporated
requested this tolerance under the Federal Food, Drug, and Cosmetic Act
(FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA).
DATES: This regulation is effective May 21, 2003. Objections and
requests for hearings, identified by docket ID number OPP-2003-0163,
must be received on or before July 21, 2003.
ADDRESSES: Written objections and hearing requests may be submitted
electronically, by mail, or through hand delivery/courier. Follow the
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION.
FOR FURTHER INFORMATION CONTACT: Joanne I. Miller, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington,
[[Page 27730]]
DC 20460-0001; telephone number: (703) 305-6224; e-mail address:
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 111)
¥ Animal production (NAICS 112)
¥ Food manufacturing (NAICS 311)
¥ Pesticide manufacturing (NAICS 32532)
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Get Copies of this Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under docket identification ID number OPP-2003-0163. The
official public docket consists of the documents specifically
referenced in this action, any public comments received, and other
information related to this action. Although a part of the official
docket, the public docket does not include Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. The official public docket is the collection of materials
that is available for public viewing at the Public Information and
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2,
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The docket telephone number is (703) 305-5805.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/. A frequently updated
electronic version of 40 CFR part 180 is available at
http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html,
a beta site currently under development. To access the OPPTS Harmonized
Guidelines referenced in this document, go directly to the guidelines
at http://www.epa.gov/opptsfrs/home/guidelin.htm.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in the system, select ``search,'' then key in the
appropriate docket ID number.
II. Background and Statutory Findings
In the Federal Register of November 20, 2002 (67 FR 70073) (FRL-
7184-7), EPA issued a notice pursuant to section 408 of FFDCA, 21
U.S.C. 346a, as amended by FQPA (Public Law 104-170), announcing the
filing of a pesticide petition (1F6428) by Nichino America
Incorporated, 4550 New Linden Hill Road, Suite 501, Wilmington, DE
19808. That notice included a summary of the petition prepared by
Nichino America Incorporated, the registrant. There were no comments
received in response to the notice of filing.
The petition requested that 40 CFR 180.585 be amended by
establishing tolerances for combined residues of the herbicide
pyraflufen-ethyl (ethyl 2-chloro-5-(4-chloro-5-difluoromethoxy-1-
methyl-1H-pyrazol-3-yl)-4-fluorophenoxyacetate) and its acid
metabolite, E-1 (2-chloro-5-(4-chloro-5-difluoromethoxy-1-methyl-1H-
pyrazol-3-yl)-4-fluorophenoxyacetic acid), expressed as the ester
equivalent in or on cotton undelinted seed at 0.05 parts per million
(ppm) and cotton gin byproduct at 1.5 ppm.
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of the FFDCA defines ``safe'' to mean that ``there is
a reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of the FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see the final rule on
Bifenthrin Pesticide Tolerances November 26, 1997) (62 FR 62961) (FRL-
5754-7).
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed
the available scientific data and other relevant information in support
of this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of the FFDCA, for tolerances for residues of pyraflufen-ethyl
on cotton undelinted seed at 0.04 ppm and cotton gin byproduct at 1.5
ppm. EPA's assessment of exposures and risks associated with
establishing the tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by pyraflufen-ethyl
are discussed in Table 1 of this unit as well as the no observed
adverse effect level (NOAEL) and the lowest observed adverse effect
level (LOAEL) from the toxicity studies reviewed.
[[Page 27731]]
Table 1.--Subchronic, Chronic, and Other Toxicity
------------------------------------------------------------------------
Guideline No. Study Type Results
------------------------------------------------------------------------
870.3100 90-day oral NOAEL = 5,000 parts
toxicity in rats per million (ppm)
(456-499 milligrams/
kilograms/day (mg/kg/
day)).
LOAEL = 15,000 ppm
(1,489-1,503 mg/kg/
day) based on
clinical signs,
death, effects on
erythrocytes,
changes in clinical
chemicals for liver
function and
splenomegaly.
-------------------------------
870.3150 90-day oral NOAEL = 1,000 mg/kg/
toxicity in dogs day.
LOAEL not
established, no
effects observed.
-------------------------------
870.3200 28-Day dermal NOAEL = 1,000 mg/kg/
toxicity in rats day.
LOAEL not
established; no
effects observed.
-------------------------------
870.3700 Prenatal Maternal NOAEL >=
developmental in 1,000 mg/kg/day
rats Maternal LOAEL not
determined; no
effects observed.
Developmental NOAEL
>= 1,000 mg/kg/day.
Developmental LOAEL
not determined; no
effects observed.
-------------------------------
870.3700 Prenatal Maternal NOAEL = 20
developmental in mg/kg/day.
rabbits Maternal LOAEL= 60 mg/
kg/day based on
mortality.
Developmental = 60 mg/
kg/day.
Developmental LOAEL =
150 mg/kg/day based
on increased
incidence of
abortion.
-------------------------------
870.3800 Reproduction and Parental NOAEL =
fertility 1,000 ppm (70.8-82.3
effects mg/kg/day (M); 80.1-
91.2 (F).
Parental LOAEL =
10,000 ppm (721-844
and 813-901 mg/kg/
day) based on
decreased body
weight (bwt) and bwt
gains of F0 and
F1(M) and F1(F),
gross and
microscopic liver
lesions of (M) and
(F)-both
generations.
Reproductive NOAEL >=
10,000 ppm (721-844
and 813-901 mg/kg/
day).
Reproductive LOAEL
not determined; no
effects observed.
Offspring NOAEL =
1,000 ppm (70.8-82.3
mg/kg/day (M); 80.1-
91.2 (F).
Offspring LOAEL =
10,000 ppm (721-844
and 813-901 mg/kg/
day) based on
decreased bwt and
bwt gains of the F1
and F2 pups.
-------------------------------
870.4100 Chronic toxicity NOAEL >= 1,000 mg/kg/
in dogs day.
LOAEL not determined;
no effects observed.
-------------------------------
870.4200 Carcinogenicity NOAEL = 200 ppm
in mice (20.99 mg/kg/day
(M); 19.58 mg/kg/day
(F).
LOAEL = 1,000 ppm
(109.7 mg/kg/day
(M); 98.3 mg/kg/day
(F) based on liver
toxicity,
hepatocellular
tumors at 5,000 ppm;
possibly hemangioma/
hemangioasarcomas.
-------------------------------
870.4300 Chronic toxicity NOAEL = 2,000 ppm
in rodents/ (86.7 mg/kg/day (M);
carcinogenicity 111.5 mg/kg/day (F).
in rats LOAEL = 10,000 ppm
(468.1 mg/kg/day
(M); 578.5 mg/kg/day
(F) based on
decreased bwt and
bwt gain in males
and microcytic
anemia, liver
lesions and kidney
toxicity (both
sexes); possible
increase
pheochromocytomas in
females.
-------------------------------
870.5100 Gene nutation Non-mutagenic when
tested up to 5,000
[mu]g/plate, in
presence and absence
of metabolic
activation (S9-mix),
in S. typhimurium
strains TA98, TA100,
TA1535, TA1537 and
TA1538 and E.coli
strain WP2(uvrA).
There was no
evidence of induced
mutant colonies over
background.
-------------------------------
[[Page 27732]]
870.5300 Gene mutation In mammalian cell
gene mutation assays
at the TK locus,
L5178Y mouse
lymphoma cells
cultured in vitro
were exposed to
pyraflufen-ethyl in
dimethylsulfoxide
(DMOS) in the
absence of mammalian
metabolic activation
(S9-mix) and with S9-
mix. Concentrations
160 [mu]g/mL were
insoluble;
cytotoxicity was
seen at 80 [mu]g/mL
S9 and 160 [mu]g/mL
+S9. There was no
increase in the
number of mutant
colonies over
background in the
absence of S9-mix
but a non-
reproducible dose-
related increase in
the number of mutant
colonies was seen in
the presence of S9-
mix.
In mammalian cell
gene mutation assays
at the TK locus,
L5178Y mouse
lymphoma cells
cultured in vitro
were exposed to
pyraflufen-ethyl in
DMSO in the absence
of mammalian
metabolic activation
(S9-mix) and with S9-
mix. There was no
evidence of induced
mutant colonies over
background up to
cytotoxic
concentrations (50
[mu]g/mL-S9; and 350
[mu]g/mL +S9.
-------------------------------
870.5375 Chromosomal In a mammalian cell
aberration cytogenetics assay,
human primary
lymphocyte cultures
were exposed to
pyraflufen-ethyl in
DMSO without
metabolic activation
(S9-mix) or with S9-
mix. Compound
precipitation
occurred at 2,600
[mu]g/mL +/-S9.
There was no
evidence of
chromosomal
aberration induction
over background.
-------------------------------
870.5395 Cytogenetics In a CD-1 mouse bone
marrow micronucleus
assay, five mice/sex/
dose/harvest time
were treated via
oral gavage with
pyraflufen-ethyl in
corn oil. ET-751 was
tested to the limit
(LTD) dose of 5,000
mg/kg bwt. Signs of
compound toxicity
were limited to
piloerection,
hunched posture in
one female, and
piloerection and
hunched posture in
one male receiving
5,000 mg/kg. No bone
marrow cytotoxicity
was seen at any
dose. There was no
statistically
significant increase
in the frequency of
micronucleated
polychromatic
erythrocytes in bone
marrow after any
dose or treatment
time.
-------------------------------
870.5500 Bacillus subtilis In a differential
killing/growth
inhibition assay in
bacteria, strains
H17 (rec+) and M45
(rec-) of B.
subtilis were
exposed to
pyraflufen-ethyl in
DMSO in the presence
and absence of
metabolic activation
(S9-mix). There was
no evidence of
greater growth
inhibition or cell
killing in repair-
defective strains
compared to repair
competent strains up
to the limit of test
material solubility.
-------------------------------
870.5550 Unscheduled DNA In an in vivo/in
synthesis (UDS) vitro UDS assay in
rat hepatocytes,
pyraflufen-ethyl was
administered to five
SPF outbred albino
Hsd/Ola Sprague-
Dawley male rats per
test group by oral
gavage (four of the
five rats were used
for hepatocyte
culture). No signs
of overt toxicity to
the test animals or
cytotoxic effects to
the target cells
were seen up to the
LTD (2,000 mg/kg).
The mean net nuclear
grain count was
below zero for both
doses at both
treatment times
indicating no
induction of UDS as
tested in this
study.
-------------------------------
[[Page 27733]]
870.7485 Metabolism and Pyraflufen-ethyl was
pharmaco- readily absorbed and
kinetics excreted within 96
hours following a
single or repeated
oral dose of 5 mg/kg
(plasma t1/2 of 3-
3.5 hours). However,
at a dose of 500 mg/
kg, absorption was
saturated as
indicated by Cmax
values which did not
reflect the 100-fold
dose differential
(2.7-2.8 Fg eq/g for
the low-dose group
and 100-107 Fg eq-hr/
g for the high-dose
group). Following
single or multiple
oral low doses (5 mg/
kg) of pyraflufen
ethyl, urinary
excretion accounted
for 27-33% of the
administered
radioactivity
suggesting that a
multiple exposure
regimen did not
affect the
absorption/excretion
processes. Urinary
excretion was
reduced to only 5-7%
following a single
500 mg/kg dose.
Excretion via the
feces accounted for
the remainder of the
administered
radioactivity in all
treatment groups.
Analysis of biliary
excretion following
a single 5 mg/kg
dose showed that 36%
of the administered
dose appeared in the
bile. Based upon the
excretion data,
total
bioavailability of a
low dose was
approximately 56%.
Biliary excretion
data were not
available for a high-
dose group which
prevented a
definitive
assessment of
bioavailability.
Excretory patterns
did not exhibit
gender-related
variability.
However, plasma and
blood clearance was
more rapid in
females than in
males as shown by
plasma/blood
radioactivity time-
course and the
greater AUC values
for males (32.3 vs
18.4 Fg eq-hr/g for
the low-dose group
and 2,738 vs 1,401
Fg eq-hr/g for the
high-dose group).
Radioactivity
concentrations
indicated tissue
concentrations at or
near detection
limits (generally
<0.01 Fg eq/g and
never exceeding 0.02
Fg eq/g) at 96 hrs
postdose for any
tissues. Therefore,
neither pyraflufen-
ethyl nor its
metabolites appear
to undergo
significant
sequestration.
Tissue burden data
following compound
administration did
not suggest a
specific target
beyond those
tissues, namely
liver and kidney,
which are associated
with absorption and
elimination of
orally administered
xenobiotics.
------------------------------------------------------------------------
B. Toxicological Endpoints
The dose at which no observed adverse effects levels are (the
NOAEL) from the toxicology study identified as appropriate for use in
risk assessment is used to estimate the toxicological level of concern
(LOC). However, the lowest dose at which observed adverse effects of
levels concern are identified (the LOAEL) is sometimes used for risk
assessment if no NOAEL was achieved in the toxicology study selected.
An uncertainty factor (UF) is applied to reflect uncertainties inherent
in the extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns. An UF of 100 is routinely used, 10X to account for
interspecies differences and 10X for intraspecies differences.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (aRfD or cRfD) where
the RfD is equal to the NOAEL divided by the appropriate UF (RfD =
NOAEL/UF). Where an additional safety factor (SF) is retained due to
concerns unique to the FQPA, this additional factor is applied to the
RfD by dividing the RfD by such additional factor. The acute or chronic
Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to
accommodate this type of FQPA SF.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the LOC. For example, when 100 is the appropriate UF (10X
to account for interspecies differences and 10X for intraspecies
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and
compared to the LOC.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk is expressed as 1 x 10-6 or one in a million).
Under certain specific circumstances, MOE calculations will be used for
the carcinogenic risk assessment. In this non-linear approach, a
``point of departure'' is identified below which carcinogenic effects
are not expected. The point of departure is typically a NOAEL based on
an endpoint related to cancer effects though it may be a different
value derived from the dose response curve. To estimate risk, a ratio
of the point of departure to exposure (MOEcancer = point of
departure/exposures) is calculated. A summary of the toxicological
endpoints for pyraflufen-ethyl used for human risk assessment is shown
in Table 2:
[[Page 27734]]
Table 2.--Summary of Toxicological Dose and Endpoints for pyraflufen-ethyl for use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
Hazard Based Special Endpoint for Risk
Exposure Scenario Dose (mg/kg/day) UF/MOE FQPA Safety Factor Assessment
----------------------------------------------------------------------------------------------------------------
Dietary Risk Assessments
----------------------------------------------------------------------------------------------------------------
Acute dietary Not applicable Not applicable No adverse effect
attributable to a
single exposure (dose)
was observed in oral
toxicity studies,
including the
developmental toxicity
studies in rats and
rabbits.
--------------------------------------
Chronic dietary NOAEL= 20 1X Mouse carcinogenicity.
UF = 100............... LOAEL = 98 mg/kg/day
Chronic RfD = 0.20 mg/ based on liver
kg/day. toxicity.
--------------------------------------
Incidental oral short-term (1-30 NOAEL= 20 1X Developmental toxicity-
days) residential only UF = 100............... rabbit.
MOE=100................ LOAEL = 60 mg/kg/day
based on decreases in
body weight and food
consumption, GI
observations, and
abortions.
--------------------------------------
Incidental oral intermediate-term (1- NOAEL= 20 1X Mouse carcinogenicity.
6 months) residential only UF = 100............... LOAEL = 98 mg/kg/day
MOE=100................ based on liver
toxicity at interim
sacrifice.
--------------------------------------
Non-Dietary Risk Assessments
----------------------------------------------------------------------------------------------------------------
Dermal short-term and intermediate- Not applicable Not applicable In a 28-dermal toxicity
term study in rats, no
dermal or systemic
toxicity was seen at
the LTD (1,000 mg/kg/
day). The physical and
chemical
characteristics (e.g.,
Kow is low) indicate
that dermal absorption
is not expected to
occur to any
appreciable extent.
There is no concern
for prenatal and/or
postnatal toxicity.
Therefore, no hazard
was identified and
quantification of
dermal risk is not
required.
--------------------------------------
Residential MOE = not applicable Not applicable
--------------------------------------
Occupational MOE = not applicable Not applicable
--------------------------------------
Inhalation1 short-term (1-30 days) Oral NOAEL= 20 1X Developmental toxicity-
rabbit.
LOAEL = 60 mg/kg/day
based on decreases in
bwt and food
consumption, GI
observations, and
abortions.
--------------------------------------
Residential MOE = 100
--------------------------------------
Occupational MOE= 100
--------------------------------------
Inhalation1 intermediate-term (1-6 Oral NOAEL= 20 1X Mouse carcinogenicity.
months) LOAEL = 98 mg/kg/day
based on liver
toxicity at interim
sacrifice.
--------------------------------------
Residential MOE = 100
--------------------------------------
Occupational MOE= 100
--------------------------------------
Inhalation1 long-term (< 6 months) Oral NOAEL= 20 1X Mouse carcinogenicity.
LOAEL = 98 mg/kg/day
based on liver
toxicity.
--------------------------------------
Residential MOE =100
--------------------------------------
Occupational MOE= 100
--------------------------------------
Cancer Classification: ``Likely to be Carcinogenic to Humans'' by the oral route
Q1* = 3.32 x 10-2 (mg/kg/day)-1
----------------------------------------------------------------------------------------------------------------
1-Oral endpoints were selected because inhalation studies were unavailable. Absorption via the inhalation route
is presumed to be equivalent to oral absorption.
* The reference to the FQPA SF refers to any additional SF retained due to concerns unique to the FQPA.
[[Page 27735]]
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.585) for the combined residues of pyraflufen-
ethyl (ethyl 2-chloro-5-(4-chloro-5-difluoromethoxy-1-methyl-1H-
pyrazol-3-yl)-4-fluorophenoxyacetate) and its acid metabolite, E-1 (2-
chloro-5-(4-chloro-5-difluoromethoxy-1-methyl-1H-pyrazol-3-yl)-4-
fluorophenoxyacetic acid), expressed as the ester equivalent in or on a
variety of raw agricultural commodities. Risk assessments were
conducted by EPA to assess dietary exposures from pyraflufen-ethyl in
food as follows:
i. Acute exposure. Acute dietary risk assessments are performed for
a food-use pesticide if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a 1-day or
single exposure. No adverse effect attributable to a single exposure
(dose) of pyraflufen-ethyl was observed in the oral toxicity studies,
including the developmental toxicity studies in rats and rabbits.
Therefore, EPA did not identify an acute dietary endpoint and an acute
dietary assessment was not performed because no acute risk is expected.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment the Dietary Exposure Evaluation Model (DEEMTM)
analysis evaluated the individual food consumption as reported by
respondents in the United State Department of Agriculture (USDA)
nationwide Continuing Surveys of Food Intake by Individuals (CSFII)
1989-1992 and accumulated exposure to the chemical for each commodity.
The following assumptions were made for the chronic exposure
assessments: 100% crop treated (PCT) and tolerance-level residues for
pyraflufen-ethyl on all treated crops. This assessment was Tier I
analysis. The exposure from pyraflufen-ethyl residues in food occupies
less than 1% of the chronic population adjusted dose (cPAD) for all
population subgroups and is not a concern.
iii. Cancer. The cancer dietary exposure assessment was conducted
using the DEEM analysis evaluated the individual food consumption as
reported by respondents in the USDA nationwide CSFII 1989-1992 and
accumulated exposure to the chemical for each commodity. The following
assumptions were made for the cancer assessments: 100% PCT and
tolerance-level residues for pyraflufen-ethyl on all treated crops. The
estimated exposure to the U.S. population (total) to pyraflufen-ethyl
is 2 x 10-5 mg/kg/day. Applying the Q1* of 0.0332
(mg/kg/day)-1 to the exposure value results in a cancer risk
estimate of 6.6 x 10-7. Therefore, the lifetime cancer risk
to the U.S. population is below EPA's level of concern.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for pyraflufen-ethyl in drinking
water. Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the chemical and
physical characteristics of pyraflufen-ethyl.
The Agency uses the First Index Reservoir Screening Tool (FIRST) or
the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS),
to produce estimates of pesticide concentrations in an index reservoir.
The Screening Concentration in Ground Water (SCI-GROW) model is used to
predict pesticide concentrations in shallow ground water. For a
screening-level assessment for surface water EPA will use FIRST (a tier
1 model) before using PRZM/EXAMS (a tier 2 model). The FIRST model is a
subset of the PRZM/EXAMS model that uses a specific high-end runoff
scenario for pesticides. While both FIRST and PRZM/EXAMS incorporate an
index reservoir environment, the PRZM/EXAMS model includes a PCT crop
area factor as an adjustment to account for the maximum PCT crop
coverage within a watershed or drainage basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever exceed human health levels of concern.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs) from these models to quantify
drinking water exposure and risk as a percent referance dose (%RfD) or
percent population adjusted dose (%PAD). Instead, drinking water levels
of comparison (DWLOCs) are calculated and used as a point of comparison
against the model estimates of a pesticide's concentration in water.
DWLOCs are theoretical upper limits on a pesticide's concentration in
drinking water in light of total aggregate exposure to a pesticide in
food, and from residential uses. Since DWLOCs address total aggregate
exposure to pyraflufen-ethyl they are further discussed in the
aggregate risk sections below.
Based on the FIRST and SCI-GROW models the EECs of pyraflufen-ethyl
for acute exposures are estimated to be 1.25 parts per billion (ppb)
for surface water and 0.002 ppb for ground water. The EECs for chronic
exposures are estimated to be 0.28 ppb for surface water and 0.002 ppb
for ground water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Pyraflufen-ethyl is currently registered for use on the following
residential non-dietary sites: Airports, nurseries, ornamental turf,
golf courses, roadsides, and railroads. The risk assessment was
conducted using the following residential exposure assumptions: adults
and children may be exposed to residues of pyraflufen-ethyl through
postapplication contact with treated areas which may include
residential/recreational areas.
4. Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA does not have, at this time, available data to determine
whether pyraflufen-ethyl has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
pyraflufen-ethyl does not appear to produce a toxic metabolite produced
by other substances. For the purposes of this tolerance action,
therefore, EPA has not assumed that pyraflufen-ethyl has a common
mechanism of toxicity with other substances. For information regarding
EPA's efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
the final rule for
[[Page 27736]]
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).
D. Safety Factor for Infants and Children
1. In general. Section 408 of the FFDCA provides that EPA shall
apply an additional tenfold margin of safety (MOS) for infants and
children in the case of threshold effects to account for prenatal and
postnatal toxicity and the completeness of the database on toxicity and
exposure unless EPA determines that a different MOS will be safe for
infants and children. MOS are incorporated into EPA risk assessments
either directly through use of a MOE analysis or through using
uncertainty (safety) factors in calculating a dose level that poses no
appreciable risk to humans.
2. Prenatal and postnatal sensitivity. There is no evidence of
increased susceptibility of rat or rabbit fetuses following in utero
exposure in the developmental studies with pyraflufen-ethyl. There is
no evidence of increased susceptibility of young rats in the
reproduction study with pyraflufen-ethyl. EPA concluded there are no
residual uncertainties for prenatal and/or postnatal exposure.
3. Conclusion. There is a complete toxicity database for
pyraflufen-ethyl and exposure data are complete or are estimated based
on data that reasonably accounts for potential exposures. The field
trial data on cotton, while some of which may be limited in geographic
representation or lack of early season application, indicate that
residues of pyraflufen-ethyl are expected to be finite. EPA determined
that the 10X SF to protect infants and children should be removed and
instead, a different additional safety factor of 1X should be used. The
FQPA factor is removed because: There is no evidence of increased
susceptibility of rat or rabbit fetuses following in utero exposure in
the developmental studies with pyraflufen-ethyl; there is no evidence
of increased susceptibility of young rats in the reproduction study
with pyraflufen-ethyl; there are no residual uncertainties identified
in the exposure databases; the dietary food exposure assessment is
expected to be conservative, tolerance-level residues and 100% crop
treated information were used; and dietary drinking water exposure is
based on conservative modeling estimates.
E. Aggregate Risks and Determination of Safety
To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against the model estimates of
a pesticide's concentration in water (EECs). DWLOC values are not
regulatory standards for drinking water. DWLOCs are theoretical upper
limits on a pesticide's concentration in drinking water in light of
total aggregate exposure to a pesticide in food and residential uses.
In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water e.g., allowable chronic water exposure (mg/kg/day) =
cPAD - (average food + residential exposure). This allowable exposure
through drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and bwts. Default bwts and consumption values as used by
the United States Environmental Protection Agency Office of Water are
used to calculate DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg
(adult female), and 1L/10 kg (child). Default bwts and drinking water
consumption values vary on an individual basis. This variation will be
taken into account in more refined screening-level and quantitative
drinking water exposure assessments. Different populations will have
different DWLOCs. Generally, a DWLOC is calculated for each type of
risk assessment used: Acute, short-term, intermediate-term, chronic,
and cancer.
When EECs for surface water and ground water are less than the
calculated DWLOCs, EPA concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which EPA has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because EPA considers the aggregate risk resulting from
multiple exposure pathways associated with a pesticide's uses, levels
of comparison in drinking water may vary as those uses change. If new
uses are added in the future, EPA will reassess the potential impacts
of residues of the pesticide in drinking water as a part of the
aggregate risk assessment process.
1. Acute risk. No adverse effect attributable to a single exposure
(dose) of pyraflufen-ethyl was observed in the oral toxicity studies,
including the developmental toxicity studies in rats and rabbits.
Therefore, an acute RfD was not established and no acute risk is
expected.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
pyraflufen-ethyl from food will utilize <1% of the cPAD for the U.S.
population and <1% of the cPAD for children (1-6 years). Based on the
use pattern, chronic residential exposure to residues of pyraflufen-
ethyl is not expected. In addition, there is potential for chronic
dietary exposure to pyraflufen-ethyl in drinking water. After
calculating DWLOCs and comparing them to the EECs for surface and
ground water, EPA does not expect the aggregate exposure to exceed 100%
of the cPAD, as shown in the following Table 3:
Table 3.--Aggregate Risk Assessment for Chronic (Non- Cancer) Exposure to Pyraflufen-ethyl
----------------------------------------------------------------------------------------------------------------
Surface Ground Chronic
Population Subgroup1 cPAD mg/kg/ % cPAD Water EEC Water EEC DWLOC
day (Food) (ppb)2 (ppb)2 (ppb)3
----------------------------------------------------------------------------------------------------------------
U.S population 0.20 <1 0.28 0.002 7,000
------------------------------------------------
Males (20+ years old) 0.20 <1 0.28 0.002 7,000
------------------------------------------------
Females (13-50 years old) 0.20 <1 0.28 0.002 6,000
------------------------------------------------
Children (1-6 years old) 0.20 <1 0.28 0.002 2,000
------------------------------------------------
Males (13-19 years old) 0.20 <1 0.28 0.002 7,000
----------------------------------------------------------------------------------------------------------------
1 Subgroups with the highest food-source dietary exposure were selected for adult males, adult females and
children. The following bwts were used (70 kg adult male; 60 kg adult females; 10 kg child).
2 The crop producing the highest level was used (potatoes, 0.009 lb active ingredient/acre).
3 Chronic DWLOC (ppb) = [maximum chronic water exposure (mg/kg/day) x bwt (kg)]
/ [water consumption (L) x 10-3
mg/kg]).
[[Page 27737]]
3. Short-term risk. The short-term aggregate risk assessment
estimates risks likely to result from 1-30 days exposure to pyraflufen-
ethyl residues from food, drinking water, and residential pesticide
uses. High-end estimates of residential exposure are used in the short-
term aggregate assessment, while average (chronic) values are used to
account for dietary (food only) exposure. The short-term aggregate risk
assessment is considered conservative because food-source dietary
exposure is based on a Tier 1 DEEM assessment (tolerance level residues
and 100% crop treated information were used).
A short-term aggregate risk assessment is not performed for adults
because no handler exposure is expected and postapplication inhalation
exposure is expected to be negligible. A short-term aggregate risk
assessment is required for infants and children because there is a
potential for oral post-application exposure resulting from residential
uses.
Pyraflufen-ethyl is currently registered for use that could result
in short-term residential exposure and the Agency has determined that
it is appropriate to aggregate chronic food and water and short-term
exposures for pyraflufen-ethyl.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food and residential exposures
aggregated result in aggregate MOEs of 170,000 for children (1-6 years
old). These aggregate MOEs do not exceed the Agency's level of concern
for aggregate exposure to food and residential uses. In addition,
short-term DWLOCs were calculated and compared to the EECs for chronic
exposure of pyraflufen-ethyl in ground and surface water. After
calculating DWLOCs and comparing them to the EECs for surface and
ground water, EPA does not expect short-term aggregate exposure to
exceed the Agency's level of concern, as shown in Table 4:
Table 4.--Aggregate Risk Assessment for Short-Term Exposure to Pyraflufen-ethyl
----------------------------------------------------------------------------------------------------------------
Aggregate
Aggregate MOE Level of Surface Ground Short-Term
Population Subgroup (Food + Concern Water EEC Water EEC DWLOC
Residential)1 (LOC) (ppb)2 (ppb)2 (ppb)3
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old) 170,000 100 0.28 0.002 2,000
----------------------------------------------------------------------------------------------------------------
1 Aggregate MOE = NOAEL (Avg Food Exposure + Residential Exposure).
2 The crop producing the highest level was used (potatoes, 0.009 lb ai/acre).
3DWLOC(ppb) = [maximum water exposure (mg/kg/day) x bwt (kg)]
/ [water consumption (L) x 10-3 mg/kg]
*(bwt: Children-10 kg).
4. Intermediate-term risk. The intermediate-term aggregate risk
assessment estimates risks likely to result from 1-6 months of exposure
to pyraflufen-ethyl residues from food, drinking water, and residential
pesticide uses. High-end estimates of residential exposure are used in
the intermediate-term assessment, while average values are used for
food and drinking water exposure.
An intermediate-term aggregate risk assessment is not preformed for
adults because no handler exposure is expected and postapplication
inhalation exposure is expected to be negligible. Also, an
intermediate-term aggregate risk assessment is not preformed for
infants and children because postapplication exposure over the
intermediate-term duration is not likely based on the use pattern.
5. Aggregate cancer risk for U.S. population. Pyraflufen-ethyl has
been classified as a ``Likely to be Carcinogenic to Humans'' by the
oral route of exposure (Q1* of 3.32 x 10-2 (mg/
kg/day)-1). Using the exposure assumptions discussed in this
unit for cancer, the cancinogenic risk is determined for the U.S.
population (total) only. The aggregate cancer DWLOC (2.3 ppb) is
greater than EPA's estimates of pyraflufen-ethyl residues in drinking
water. Therefore, the aggregate cancer risk from residues of
pyraflufen-ethyl in food and drinking water does not exceed EPA's level
of concern as shown in the following Table 5:
Table 5.--Cancer DWLOC Calculations for the U.S. Population
----------------------------------------------------------------------------------------------------------------
Aggregate
Negligible cancer risk Ground Surface Cancer
Q1* mg/kg/day)-1 Risk Level1 (food and Water EEC2 Water EEC2 DWLOC3
residential (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
0.0332 3.0E-6 8.3E-7 0.002 0.28 2.3
----------------------------------------------------------------------------------------------------------------
1 Negligible risk is that below 10-6. 3.0E-6 is statistically within the range that EPA generally accepts as
``negligible risk''.
2 The crop producing the highest level was used (potatoes).
3Cancer DWLOC (ppb) = [maximum water exposure (mg/kg/day) x bwt (kg)]
/ [water consumption (L) x 10-3 mg/kg]
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to pyraflufen-ethyl residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Nichino America, Inc. has submitted a petition method validation
(PMV) and an independent laboratory validation for a Gas
Chromatography/Mass Spectometry (GC/MS) method proposed for the
enforcement of tolerances for residues of pyraflufen ethyl and its acid
metabolite, E-1. The proposed plant method is adequate for enforcement
of tolerances in/on cotton.
Adequate enforcement methodology (example--GC) is available to
enforce the tolerance expression. The method may be requested from:
Chief, Analytical Chemistry Branch, Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905;
e-mail address: residuemethods@epa.gov.
[[Page 27738]]
B. International Residue Limits
There is neither a Codex proposal, nor Canadian or Mexican limits,
for residues of pyraflufen-ethyl in/on cotton. Harmonization is not an
issue for this petition.
C. Conditions
A risk assessment for human health has been conducted for this
proposed use. Using the proposed or recommended tolerances, the chronic
estimates are well below the Agency's level of concern and the cancer
risk estimate is also within Agency's level of concern. The following
data are being required by the Agency to complete the database
requirements prior to approval of an unconditional registration of
pyraflufen-ethyl on cotton:
¥ Product label contain a statement limiting use to
commercial applicators only so that possible use by homeowners on
residential turf would be minimized and/or include a restriction
prohibiting use by homeowners for the turf and ornamental use sites.
¥ Proposed uses in farmyards, farm buildings, fence lines,
dry ditches and ditch banks be removed from the label due to the
potential for residues to contact food sources in these use sites.
¥ The label for pyraflufen ethyl should clearly state the
allowable number of applications per season.
V. Conclusion
Therefore, tolerances are established for combined residues of
pyraflufen-ethyl (ethyl 2-chloro-5-(4-chloro-5-difluoromethoxy-1-
methyl-1H-pyrazol-3-yl)-4-fluorophenoxyacetate) and its acid
metabolite, E-1 (2-chloro-5-(4-chloro-5-difluoromethoxy-1-methyl-1H-
pyrazol-3-yl)-4-fluorophenoxyacetic acid), expressed pyraflufen-ethyl
in or on cotton undelinted seed at 0.04 ppm and cotton gin byproduct at
1.5 ppm.
VI. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA, EPA will continue to use those procedures, with
appropriate adjustments, until the necessary modifications can be made.
The new section 408(g) of the FFDCA provides essentially the same
process for persons to ``object'' to a regulation for an exemption from
the requirement of a tolerance issued by EPA under new section 408(d)
of FFDCA, as was provided in the old sections 408 and 409 of the FFDCA.
However, the period for filing objections is now 60 days, rather than
30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number OPP-2003-0163 in the subject line on the
first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before July 21,
2003.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900C),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Rm.104, Crystal Mall #2, 1921
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Office of the Hearing Clerk is
(703) 603-0061.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at 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-2003-0163, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the
PIRIB described in Unit I.B.1. You may also send an electronic copy of
your request via e-mail to: 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
[[Page 27739]]
issues(s) in the manner sought by the requestor would be adequate to
justify the action requested (40 CFR 178.32).
VII. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of the
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does
not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under section 408(d) of the FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled
Federalism(64 FR 43255, August 10, 1999). Executive Order 13132
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by State and local officials in the development of
regulatory policies that have federalism implications.'' ``Policies
that have federalism implications'' is defined in the Executive Order
to include regulations that have ``substantial direct effects on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government.'' This final rule directly regulates
growers, food processors, food handlers and food retailers, not States.
This action does not alter the relationships or distribution of power
and responsibilities established by Congress in the preemption
provisions of section 408(n)(4) of the FFDCA. For these same reasons,
the Agency has determined that this rule does not have any ``tribal
implications'' as described in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments
(65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by tribal officials in the development of regulatory policies that have
tribal implications.'' ``Policies that have tribal implications'' is
defined in the Executive Order to include regulations that have
``substantial direct effects on one or more Indian tribes, on the
relationship between the Federal Government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes.'' This rule will not have substantial
direct effects on tribal governments, on the relationship between the
Federal Government and Indian tribes, or on the distribution of power
and responsibilities between the Federal Government and Indian tribes,
as specified in Executive Order 13175. Thus, Executive Order 13175 does
not apply to this rule.
VIII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: May 7, 2003.
Debra Edwards,
Director, Registration Division, Office of Pesticide Programs.
¥ 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 amended by alphabetically adding commodities in
the table in paragraph (a) to read as follows:
Sec. 180.585 Pyraflufen-ethyl; tolerances for residues.
(a) * * *
----------------------------------------------------------------------
Commodity Parts per million
----------------------------------------------------------------------
Cotton, gin byproduct............ 1.5
Cotton, undelinted seed.......... 0.04
----------------------------------------------------------------------
[[Page 27740]]
* * * * *
[FR Doc. 03-12359 Filed 5-20-03; 8:45 am]
BILLING CODE 6560-50-S