Trifloxystrobin; Pesticide Tolerances for Emergency Exemptions, 36524-36533 [05-12447]
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Federal Register / Vol. 70, No. 121 / Friday, June 24, 2005 / Rules and Regulations
51735, October 4, 1993), this action is
not a ‘‘significant regulatory action’’ and
is, therefore, not subject to review by the
Office of Management and Budget
(‘‘OMB’’). This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2). The
technical correction does not impose an
information collection burden under the
provisions of the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.).
Because EPA has made a ‘‘good
cause’’ finding that this action is not
subject to notice and comment
requirements under the APA or any
other statute, it is not subject to the
regulatory flexibility provisions of the
Regulatory Flexibility Act (5 U.S.C. 601
et seq.), or to sections 202 and 205 of the
Unfunded Mandates Reform Act of 1995
(Pub. L. 104–4). In addition, this action
does not significantly or uniquely affect
small governments or impose a
significant intergovernmental mandate,
as described in sections 203 and 204 of
the UMRA.
The correction does not have
substantial direct effects on the States,
or 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, Federalism (64
FR 43255, August 10, 1999).
Today’s action also does not
significantly or uniquely affect the
communities of tribal governments, as
specified by Executive Order 13175,
Consultation and Coordination with
Indian Tribal Governments (65 FR
67249, November 9, 2000). The
technical correction also is not subject
to Executive Order 13045, Protection of
Children from Environmental Health
and Safety Risks (62 FR 19885, April 23,
1997) because it is not economically
significant.
The correction is not subject to
Executive Order 13211, Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001) because it is not a significant
regulatory action under Executive Order
12866.
Section 553 of the Administrative
Procedure Act (APA), 5 U.S.C.
553(b)(B), provides that, when an
Agency for good cause finds that notice
and public procedure are impracticable,
unnecessary, or contrary to the public
interest, the Agency may issue a rule
without providing notice and an
opportunity for public comment. We
have determined that there is good
cause for making today’s action final
without prior proposal and opportunity
for comment because the change to the
rule corrects an error, is
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noncontroversial, and is consistent with
the technical basis of the rule. Thus,
notice and public procedure are
unnecessary. We find that this
constitutes good cause under 5 U.S.C.
553(b)(B) (see also the final sentence of
section 307(d)(1) of the CAA, 42 U.S.C.
7607(d)(1), indicating that the good
cause provisions of the APA continue to
apply to rulemaking under section
307(d) of the Clean Air Act (CAA).
Section 553(d)(3) allows an agency,
upon a finding of good cause, to make
a rule effective immediately. Because
today’s changes relieve an unintended
restriction, we find good cause to make
these technical corrections effective
immediately.
The correction action does not
involve changes to the technical
standards related to test methods or
monitoring methods; thus, the
requirements of section 12(d) of the
National Technology Transfer and
Advancement Act of 1995 (15 U.S.C.
272) do not apply.
The correction also does not involve
special consideration of environmental
justice-related issues as required by
Executive Order 12898, Federal Actions
to Address Environmental Justice in
Minority Populations and Low-Income
Populations (59 FR 7629, February 16,
1994).
The Congressional Review Act, 5
U.S.C. 801 et seq., as added by SBREFA
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
U.S. The EPA will submit a report
containing this final action and other
required information to the U.S. Senate,
the U.S. House of Representatives, and
the Comptroller General of the U.S.
prior to publication of today’s action in
the Federal Register. Today’s action is
not a ‘‘major rule’’ as defined by 5
U.S.C. 804(2). The final rule will be
effective on June 24, 2005.
List of Subjects in 40 CFR Part 63
Environmental protection,
Administrative practice and procedure,
Air pollution control, Hazardous
substances, Intergovernmental relations,
Reporting and recordkeeping
requirements.
Dated: June 16, 2005.
Jeffrey R. Holmstead,
Assistant Administrator for Air and
Radiation.
For the reasons set out in the preamble,
title 40, chapter I, part 63 of the Code of
Federal Regulations is amended as
follows:
I
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PART 63—[AMENDED]
1. The authority citation for part 63
continues to read as follows:
I
Authority: 42 U.S.C. 7401 et seq.
Subpart UUUU—[Amended]
2. Section 63.5610 is amended by
revising the following definitions in
paragraph (g) to read as follows:
I
§ 63.5610
subpart?
What definitions apply to this
*
*
*
*
*
(g) * * *
Cellulose ether process change means
a change to the cellulose ether process
that occurred no earlier than January
1991 that allows the recovery of organic
HAP, reduction in organic HAP usage,
or reduction in organic HAP leaving the
reactor. Includes extended cookout.
*
*
*
*
*
Viscose process change means a
change to the viscose process that
occurred no earlier than January 1991
that allows either the recovery of carbon
disulfide or a reduction in carbon
disulfide usage in the process.
*
*
*
*
*
[FR Doc. 05–12576 Filed 6–23–05; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[OPP–2005–0155; FRL–7720–2]
Trifloxystrobin; Pesticide Tolerances
for Emergency Exemptions
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes a
time-limited tolerance for combined
residues of trifloxystrobin in or on
soybean, forage; soybean, hay; and
soybean, seed. This action is in response
to EPA’s granting of an emergency
exemption under section 18 of the
Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) authorizing
use of the pesticide on soybeans. This
regulation establishes a maximum
permissible level for residues of
trifloxystrobin in this food commodity.
The tolerances will expire and are
revoked on December 31, 2009.
DATES: This regulation is effective June
24, 2005. Objections and requests for
hearings must be received on or before
August 23, 2005.
ADDRESSES: To submit a written
objection or hearing request follow the
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detailed instructions as provided in
Unit VII. of the SUPPLEMENTARY
INFORMATION. EPA has established a
docket for this action under docket
identification (ID) number OPP–2005–
0155. All documents in the docket are
listed in the EDOCKET index at http:/
/www.epa.gov/edocket/. Although listed
in the index, some information is not
publicly available, i.e., Confidential
Business Information (CBI) or other
information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
is not placed on the Internet and will be
publicly available only in hard copy
form. Publicly available docket
materials are available either
electronically in EDOCKET or in hard
copy at the Public Information and
Records Integrity Branch (PIRIB), Room
119, Crystal Mall #2, 1801 S. Bell St.,
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.
FOR FURTHER INFORMATION CONTACT:
Carmen Rodia, Registration Division
(7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 306–0327; fax number: (703) 308–
5433; e-mail address:
rodia.carmen@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to:
• 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.
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B. How Can I Access Electronic Copies
of this Document and Other Related
Information?
In addition to using EDOCKET (http:/
/www.epa.gov/edocket/), you may
access this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr/. A
frequently updated electronic version of
40 CFR part 180 is available on E-CFR
Beta Site Two at https://
www.gpoaccess.gov/ecfr/.
II. Background and Statutory Findings
EPA, on its own initiative, in
accordance with sections 408(e) and 408
(l)(6) of the Federal Food, Drug, and
Cosmetic Act (FFDCA), 21 U.S.C. 346a,
is establishing a tolerance for combined
residues of the fungicide trifloxystrobin,
(benzeneacetic acid, (E,E)-[alpha](methoxyimino)-2-[[[[1-[3(trifluoromethyl)phenyl]ethylidene]
amino]oxy]methyl]-,methylester) and
the free form of its acid metabolite
CGA–321113 ((E,E)-methoxyimino-[2-[1(3-trifluoromethylphenyl)
ethylideneaminooxymethyl]-phenyl]
acetic acid) in or on soybean, forage at
4.0 parts per million (ppm); soybean,
hay at 6.5 ppm; and soybean, seed at
0.04 ppm. These tolerances will expire
and are revoked on December 31, 2009.
EPA will publish a document in the
Federal Register to remove the revoked
tolerances from the Code of Federal
Regulations (CFR).
Section 408(l)(6) of FFDCA requires
EPA to establish a time-limited
tolerance or exemption from the
requirement for a tolerance for pesticide
chemical residues in food that will
result from the use of a pesticide under
an emergency exemption granted by
EPA under section 18 of FIFRA. Such
tolerances can be established without
providing notice or period for public
comment. EPA does not intend for its
actions on FIFRA section 18 related
tolerances to set binding precedents for
the application of section 408 of FFDCA
and the new safety standard to other
tolerances and exemptions. Section
408(e) of FFDCA allows EPA to
establish a tolerance or an exemption
from the requirement of a tolerance on
its own initiative, i.e., without having
received any petition from an outside
party.
Section 408(b)(2)(A)(i) of 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 FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
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36525
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 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. . . .’’
Section 18 of FIFRA authorizes EPA
to exempt any Federal or State agency
from any provision of FIFRA, if EPA
determines that ‘‘emergency conditions
exist which require such exemption.’’
This provision was not amended by the
Food Quality Protection Act of 1996
(FQPA). EPA has established regulations
governing such emergency exemptions
in 40 CFR part 166.
III. Emergency Exemption for
Trifloxystrobin on Soybeans and
FFDCA Tolerances
Multiple States throughout the United
States have petitioned the Agency
requesting an emergency exemption for
use of trifloxystrobin to control soybean
rust under the provisions of section 18
of FIFRA. The soybean rust pathogen
(Phakopsora pachyrhizi) was recently
identified in the continental United
States. Soybean rust has been
designated as a biosecurity threat by
action of the U.S. Congress and;
therefore, it is important that control
measures be available to soybean
growers in the United States.
Accordingly, EPA has expedited review
under section 18 of FIFRA to authorize
the use of trifloxystrobin on soybeans
for control of soybean rust for requesting
states in the United States, having
concluded that emergency conditions
exist regarding this chemical use.
As part of its assessment of this
emergency exemption, EPA assessed the
potential risks presented by residues of
trifloxystrobin in or on soybeans. In
doing so, EPA considered the safety
standard in section 408(b)(2) of FFDCA,
and EPA decided that the necessary
tolerance under section 408(l)(6) of
FFDCA would be consistent with the
safety standard and with section 18 of
FIFRA. Consistent with the need to
move quickly on the emergency
exemption in order to address an urgent
non-routine situation and to ensure that
the resulting food is safe and lawful,
EPA is issuing this tolerance without
notice and opportunity for public
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comment as provided in section
408(l)(6) of FFDCA. Although these
tolerances will expire and are revoked
on December 13, 2009, under section
408(l)(5) of FFDCA, residues of the
pesticide not in excess of the amounts
specified in the tolerance remaining in
or on poultry, soybeans, or swine after
that date will not be unlawful, provided
the pesticide is applied in a manner that
was lawful under FIFRA, and the
residues do not exceed a level that was
authorized by these tolerances at the
time of that application. EPA will take
action to revoke these tolerances earlier
if any experience with, scientific data
on, or other relevant information on this
pesticide indicate that the residues are
not safe.
Because these tolerances are being
approved under emergency conditions,
EPA has not made any decisions about
whether trifloxystrobin meets EPA’s
registration requirements for use on
soybeans or whether a permanent
tolerance for this use would be
appropriate. Under these circumstances,
EPA does not believe that these
tolerances serve as a basis for
registration of trifloxystrobin by a State
for special local needs under section
24(c) of FIFRA. Nor do these tolerances
serve as the basis for any State that has
not been specifically authorized by EPA
to use this pesticide on this crop under
section 18 of FIFRA without following
all provisions of EPA’s regulations
implementing section 18 of FIFRA as
identified in 40 CFR part 166. For
additional information regarding the
emergency exemption for
trifloxystrobin, contact the Agency’s
Registration Division at the address
provided under FOR FURTHER
INFORMATION CONTACT.
IV. Aggregate Risk Assessment and
Determination of Safety
EPA performs a number of analyses to
determine the risks from aggregate
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exposure to pesticide residues. For
further discussion of the regulatory
requirements of section 408 of FFDCA
and a complete description of the risk
assessment process, see the final rule on
Bifenthrin Pesticide Tolerances (62 FR
62961, November 26, 1997) (FRL–5754–
7).
Consistent with section 408(b)(2)(D)
of 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 trifloxystrobin and to
make a determination on aggregate
exposure, consistent with section
408(b)(2) of FFDCA, for a time-limited
tolerance for combined residues of
trifloxystrobin in or on soybean, forage
at 4.0 ppm; soybean, hay at 6.5 ppm;
and soybean, seed at 0.04 ppm. EPA’s
assessment of the dietary exposures and
risks associated with establishing the
tolerance follows.
A. Toxicological Endpoints
The dose at which no adverse effects
are observed (the NOAEL) from the
toxicology study identified as
appropriate for use in risk assessment is
used to estimate the toxicological
endpoint. 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
intra species differences.
For dietary risk assessment (other
than cancer) the Agency uses the UF to
calculate an acute or chronic reference
dose (acute RfD or chronic RfD) where
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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 over risk to
children’s health, 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
Safety Factor (SF).
For non-dietary risk assessments
(other than cancer) the UF is used to
determine the level of concern (LOC).
For example, when 100 is the
appropriate UF (10x to account for
interspecies differences and 10x for
intraspecies differences) the LOC is 100.
To estimate risk, a ratio of the NOAEL
to exposures (margin of exposure (MOE)
= NOAEL/exposure) is calculated and
compared to the LOC.
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 x10-6 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 trifloxystrobin used for human risk
assessment is shown in Table 1 of this
unit:
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TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR TRIFLOXYSTROBIN FOR USE IN HUMAN RISK
ASSESSMENT
Dose used in risk assessment,
UF
FQPA SF* and level of concern
for risk assessment
Study and toxicological effects
Acute dietary
(Females 13–49 years of
age)
NOAEL = 250 milligram/kilogram/
day (mg/kg/day)
UF = 100
Acute RfD = 2.5 mg/kg/day
FQPA SF = 1x
aPAD = acute RfD/FQPA SF =
2.5 mg/kg/day
Developmental toxicity—rat
LOAEL = 500 mg/kg/day based on increased fetal skeletal anomalies.
Acute Dietary
(General U.S. population,
including infants and children).
There were no appropriate toxicological effects attributable to a single exposure (dose) observed in oral toxicity
studies including maternal effects in developmental studies in rats and rabbits. Therefore, a dose and endpoint were not identified for this risk assessment.
Chronic dietary
(All populations)
Parental NOAEL = 3.8 mg/kg/day
UF = 100
Chronic RfD = 0.038 mg/kg/day
FQPA SF = 1x
cPAD = chronic RfD/FQPA SF =
0.038 mg/kg/day
2-Generation reproduction study—rat
LOAEL = 55.3 mg/kg/day based on decreases in body weight, body weight
gains, reduced food consumption, and
histopathological lesions in the liver,
kidneys, and spleen.
Short- (1 to 30 days) and
intermediate-term (1–6
months)
Oral
Offspring NOAEL = 3.8 mg/kg/
day
LOC for MOE = 100
(residential, includes FQPA SF)
2-Generation reproduction study—rat
LOAEL = 55.3 mg/kg/day based on reduced pup body weights during lactation.
Short- (1 to 30 days) and
intermediate-term (1–6
months)
Dermal
Dermal study NOAEL = 100 mg/
kg/day
LOC for MOE = 100
(occupational)
LOC for MOE = 100
(residential, includes FQPA SF)
28-Day dermal toxicity study—rat
LOAEL = 1,000 mg/kg/day based on increases in mean absolute and relative
liver and kidney weights.
Long-term (> 6 months)
Dermal
Oral study NOAEL = 3.8 mg/kg/
day
(dermal absorption rate = 33%)
LOC for MOE = 100
(occupational)
LOC for MOE = 100
(residential, includes FQPA SF)
2-Generation reproduction study—rat
LOAEL = 55.3 mg/kg/day based on decreases in body weight, body weight
gains, reduced food consumption, and
histopathological lesions in the liver,
kidneys, and spleen.
Short- (1 to 30 days),
intermediate- (1–6
months), and long-term
(> 6 months)
Inhalation
Oral study NOAEL = 3.8 mg/kg/
day
(inhalation absorption rate =
100%)
LOC for MOE = 100
(occupational)
LOC for MOE = 100
(residential, includes FQPA SF)
2-Generation reproduction study—rat
LOAEL = 55.3 mg/kg/day based on decreases in body weight, body weight
gains, reduced food consumption, and
histopathological lesions in the liver,
kidneys, and spleen.
Exposure/scenario
Cancer
(Oral, dermal, and inhalation)
Classification: ‘‘Not Likely Human Carcinogen,’’ based on the lack of evidence of carcinogenicity in mouse and
rat cancer studies.
* The reference to the FQPA SF refers to any additional SF retained due to concerns unique to FQPA.
B. Exposure Assessment
1. Dietary exposure from food and
feed uses. Tolerances have been
established (40 CFR 180.555) for the
combined residues of trifloxystrobin, in
or on a variety of raw agricultural
commodities (RACs). Specifically,
tolerances for almonds, barley, carrots,
celery, citrus, field corn, fruiting
vegetables, hops, pecans, potatoes, rice,
stone fruits, sugar beets, and wheat. Risk
assessments were conducted by EPA to
assess dietary exposures from
trifloxystrobin in food as follows:
i. Acute exposure. Acute dietary (food
only) exposure 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
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exposure. The Dietary Exposure
Evaluation Model software with the
Food Commodity Intake Database
(DEEM-FCIDTM), Version 1.3, which
incorporates the individual food
consumption data as reported by
respondents in the United States
Department of Agriculture (USDA)
1994–1996 and 1998 nationwide
Continuing Surveys of Food Intake by
Individuals (CSFII) and accumulated
exposure to the chemical for each
commodity. The acute dietary (food
only) exposure analysis for
trifloxystrobin is unrefined, assuming
100% crop treated and tolerance level
residues. No additional data were used
to refine the analysis. The acute dietary
endpoint is applicable to the population
subgroup females, 13–49 years only. An
acute dietary endpoint for the general
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U.S. population, including infants and
children, was not identified. The
estimated dietary (food only) exposure
for females, 13–49 years old occupies
less than 1% of the aPAD and does not
exceed EPA’s level of concern.
ii. Chronic exposure. In conducting
this chronic dietary (food only)
exposure assessment, EPA used the
DEEM-FCIDTM software, incorporating
the individual food consumption data as
reported by respondents in the USDA
1994–1996 and 1998 CSFII and
accumulated exposure to the chemical
for each commodity. The chronic
dietary (food only) exposure analysis for
trifloxystrobin is unrefined, assuming
100% crop treated and tolerance level
residues. The chronic dietary endpoint
applies to all population subgroups,
including infants and children. Risk
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estimates for all population subgroups
are below EPA’s level of concern (100%
of the cPAD).
iii. Cancer. EPA’s previous reviews of
data (May 1999) related to
trifloxystrobin have determined that
trifloxystrobin should be classified as a
‘‘Not Likely Human Carcinogen.’’
Accordingly, no additional cancer risk
assessment was performed for
trifloxystrobin.
iv. Anticipated residue and percent
crop treated (PCT) information.
Established and recommended
tolerances were used in the acute and
chronic dietary (food only) exposure
assessments for trifloxystrobin. The
metabolite L7a (taurine conjugate of
trifloxystrobin) was also included in the
exposure assessment for liver, based on
the amount found in the ruminant
metabolism study. EPA did not apply
PCT data for this assessment. DEEMFCIDTM default concentration factors
were used except for tomato juice,
puree, paste, and catsup. Processing
data show no concentration in these
fractions.
2. Dietary exposure from drinking
water. The Agency lacks sufficient
monitoring exposure data to complete a
comprehensive dietary exposure
analysis and risk assessment for
trifloxystrobin in drinking water.
Because the Agency does not have
comprehensive monitoring data,
drinking water concentration estimates
are made by reliance on simulation or
modeling taking into account data on
the physical characteristics of
trifloxystrobin.
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 modeling system (SCI-GROW) is
used to predict pesticide concentrations
in shallow ground water. For a
screening-level assessment for surface
water, EPA will generally use FIRST (a
tier 2 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
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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 %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
trifloxystrobin, they are further
discussed in Unit IV.D., aggregate risk.
Based on the PRZM/EXAMS and SCIGROW models, the EECs of
trifloxystrobin for acute exposures are
estimated to be 48 parts per billion
(ppb) for surface water and 3.4 ppb for
ground water. The EECs for chronic
exposures are estimated to be 140 ppb
for surface water and 3.4 ppb for ground
water.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., for lawn and garden pest control,
indoor pest control, termiticides, and
flea and tick control on pets).
Trifloxystrobin is currently registered
for use in turf grass and ornamentals. No
new residential uses are proposed in
this action. Because FQPA requires
consideration of aggregate exposure to
all likely non-occupational uses, this
assessment uses non-occupational postapplication contact with trifloxystrobin
following potential use on turf grass as
the most common and worst case
contributor to such exposures. The
current registered use of trifloxystrobin
on turf grass and ornamentals may only
be applied by a Certified Pest Control
Operator (PCO); therefore, an
assessment of dermal or inhalation
exposure for residential handlers is not
required and was not performed.
EPA calculated MOEs for exposure
scenarios involving potential residential
exposure resulting from the currently
registered uses of the chemical. The
lowest MOE was 800 for children
resulting from direct dermal contact
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with treated lawns (this represents the
exposure scenario with the highest
exposure; conversely, the adult dermal
MOE was 1,300). The highest MOE for
children was 220,000 from ingestion of
soil from treated lawns. All calculated
non-occupational post-application
MOEs are greater than 100 on the day
of application and; therefore, did not
exceed EPA’s level of concern.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of 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.’’
Unlike other pesticides for which EPA
has followed a cumulative risk approach
based on a common mechanism of
toxicity, EPA has not made a common
mechanism of toxicity finding as to
trifloxystrobin and any other substances
and trifloxystrobin 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 trifloxystrobin has a
common mechanism of toxicity with
other substances. For information
regarding EPA’s efforts to determine
which chemicals have a common
mechanism of toxicity and to evaluate
the cumulative effects of such
chemicals, see the policy statements
released by EPA’s OPP concerning
common mechanism determinations
and procedures for cumulating effects
from substances found to have a
common mechanism on EPA’s website
at https://www.epa.gov/pesticides/
cumulative/.
C. Safety Factor for Infants and Children
1. In general. Section 408 of FFDCA
provides that EPA shall apply an
additional ten-fold margin of safety for
infants and children in the case of
threshold effects to account for prenatal
and post-natal 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 an MOE
analysis or through using UFs in
calculating a dose level that poses no
appreciable risk to humans.
2. Discussion. There is no indication
of an increased susceptibility of rat or
rabbit fetuses/pups to pre- and/or postnatal exposure to trifloxystrobin. In the
developmental and reproduction
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toxicity studies, effects in the fetuses/
pups were observed only at or above
treatment levels, which resulted in
evidence of parental toxicity. As a
result, the Agency determined that a
developmental neurotoxicity (DNT)
study in rats is not required.
The acute and chronic dietary (food
only) exposure assessments utilize
existing and proposed tolerance level
residues and 100% crop treated
information for all commodities. By
using these screening-level assessments,
actual exposures/risks will not be
underestimated. Additionally, the
exposure assessments will not
underestimate the potential dietary
(food and drinking water) or non-dietary
exposures for infants and children from
the use of trifloxystrobin.
The dietary drinking water
assessment utilizes water concentration
values generated by model and
associated modeling parameters, which
are designed to provide conservative,
health protective, high-end estimates of
water concentrations, which are not
likely to be exceeded. The residential
post-application assessment is based
upon the residential standard operating
procedures (SOPs) and is based upon
surrogate study data. These data are
reliable and are not expected to
underestimate risk to adults or children.
The residential SOPs are based upon
reasonable ‘‘worst-case’’ assumptions
and are not expected to underestimate
risk.
3. Conclusion. EPA has evaluated the
potential for increased susceptibility of
infants and children from exposure to
trifloxystrobin. There is a complete
toxicity data base for trifloxystrobin and
exposure data are complete or are
estimated based on data that reasonably
accounts for potential exposures. The
Agency has concluded that there are no
residual uncertainties for pre- and/or
post-natal toxicity. Further, based on
existing hazard data and the quality of
exposure data for trifloxystrobin, EPA
has determined that traditional 10x
safety factors are adequately protective
for all populations, and the special
FQPA SF need not be applied (e.g., it
has been reduced from 10x to 1x).
D. Aggregate Risks and Determination of
Safety
1. General discussion. 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
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(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 + chronic non-dietary, nonoccupational exposure)]. This allowable
exposure through drinking water is used
to calculate a DWLOC.
A DWLOC will vary depending on the
toxic endpoint, drinking water
consumption, and body weights. Default
body weights and consumption values
as used by the EPA’s 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
body weights and drinking water
consumption values vary on an
individual basis. This variation will be
taken into account in more refined
screening-level and quantitative
drinking water exposure assessments.
Different populations will have different
DWLOCs. Generally, a DWLOC is
calculated for each type of risk
assessment used: Acute, short-term,
intermediate-term, chronic, and cancer.
When EECs for surface water and
ground water are less than the
calculated DWLOCs, EPA concludes
with reasonable certainty that exposures
to trifloxystrobin 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
trifloxystrobin on drinking water as a
part of the aggregate risk assessment
process.
2. Summary of aggregate risk analysis.
Acute and chronic aggregate risk
estimates were calculated in this risk
assessment. Acute aggregate risk was
calculated by comparing acute DWLOCs
to potential drinking water exposure to
trifloxystrobin. Similarly, chronic
aggregate risk was calculated by
comparing chronic DWLOCs to
potential drinking water exposure. The
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surface and ground water EECs were
used to compare against back-calculated
DWLOCs for aggregate risk assessments.
Short-term risk is based on exposures
occurring over 1 to 30 days. Short-term
aggregate risk was calculated by
combining risk estimates for high-end
residential oral and/or dermal exposures
with chronic food and drinking water
risks. Intermediate-term exposure (1 to 6
months) to the parent trifloxystrobin is
not expected to occur in residential
settings due to its short half-life (about
2 days based on soil and aquatic
metabolism studies). Therefore, an
intermediate-term aggregate risk
assessment was not performed. Chronic
non-dietary aggregate risk was not
calculated as chronic dermal and oral
exposures (from residential treatment)
are not expected. Cancer aggregate risk
was not calculated because
trifloxystrobin has been classified as a
‘‘not likely human carcinogen.’’
Acute, short-term and chronic
aggregate risk estimates resulting from
aggregate exposure to trifloxystrobin in
food and drinking water were assessed,
and are below EPA’s level of concern.
3. Acute risk. The acute aggregate risk
assessment takes into account exposure
estimates from dietary consumption of
trifloxystrobin from food and drinking
water sources. Acute aggregate risk was
not calculated for the general U.S.
population (including infants and
children or other population subgroups)
as hazard endpoints have not been
identified for those groups.
The acute risk estimate for females,
13–49 years, resulting from aggregate
exposure to trifloxystrobin in food and
drinking water, is below EPA’s level of
concern. DWLOCs were calculated for
females 13–49 years, the only subgroup
to which the acute dietary endpoint
applies. Surface and ground water EECs
were used to compare against backcalculated DWLOCs for aggregate risk
assessments. To calculate the DWLOC
for acute exposure relative to an acute
toxicity endpoint, the acute dietary food
exposure (from DEEM-FCIDTM) was
subtracted from the aPAD to obtain the
acceptable acute exposure to
trifloxystrobin in drinking water.
The DWLOC was 75,000 ppb for
females, 13–49 years, a value that is
well above the EECs for drinking water.
Therefore, acute aggregate risk is below
EPA’s level of concern. EPA does not
expect the aggregate exposure to exceed
100% of the aPAD, as shown in Table
2 of this unit:
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TABLE 2.—AGGREGATE RISK ASSESSMENT FOR ACUTE EXPOSURE TO TRIFLOXYSTROBIN
aPAD
(mg/kg/day)
Population subgroup
Females 13–49 years
<1
2.5
4. Chronic risk. For the chronic
aggregate risk scenario, potential food
and drinking water exposures were
analyzed. Chronic exposure in
residential settings is not expected. The
surface and ground water EECs were
used to compare against back-calculated
DWLOCs for aggregate risk assessments.
To calculate DWLOCs for chronic
Surface
Water EEC
(ppb)
% aPAD
(Food)
Ground
Water EEC
(ppb)
92 (turf)
48 (rice)
Acute
DWLOC
(ppb)
3.4
75,000
DWLOCs ranged from 170 ppb for
children to 1,200 ppb for adults aged 50
years and older. These values are above
the EECs for drinking water. Therefore,
chronic aggregate risk is below EPA’s
level of concern. EPA does not expect
the aggregate exposure to exceed 100%
of the cPAD, as shown in Table 3 of this
unit:
exposure relative to an chronic toxicity
endpoint, the chronic dietary food
exposure (from DEEM-FCIDTM) was
subtracted from the cPAD to obtain the
acceptable chronic exposure to
trifloxystrobin in drinking water.
DWLOCs were calculated for the
general U.S. population, children aged
1–2 years, females aged 13–49 years and
adults aged 50 years and older.
TABLE 3.—AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON-CANCER) EXPOSURE TO TRIFLOXYSTROBIN
cPAD
(mg/kg/day)
Population subgroup
General U.S. population
Surface
Water EEC
(ppb)
% cPAD
(Food)
0.038
15
Children 1–2 years
Ground
Water EEC
(ppb)
140 (rice)
50 (turf)
3.4
54
5. Short-term risk. Short-term
aggregate exposure takes into account
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level).
Though residential exposure could
occur with the use of trifloxystrobin, the
potential short-term exposures were not
aggregated with chronic dietary food
and water exposures because the toxic
effects are different. Different endpoints
have been identified for short-term
incidental oral and dermal risk
assessment (the basis for the oral
endpoint is reduced pup body weights
and the dermal endpoint is based on
increases in liver and kidney weights).
Therefore, based on the best available
data and current policies, potential risks
do not exceed EPA’s level of concern.
A short-term risk assessment was not
required for adults, because no
incidental oral exposure is expected for
adults. A short-term risk assessment was
performed for infants and children
because of residential post-application
oral exposure scenarios. Incidental oral
exposure for toddlers is assumed to
include hand-to-mouth exposure,
object-to-mouth exposure and exposure
through incidental ingestion of soil.
DWLOCs were calculated for the
general U.S. population, children aged
1–2 years, females aged 13–49 years and
adults 50 years and older. DWLOCs
Chronic
DWLOC
(ppb)
1,100
170
ranged from 130 ppb for children to
1,200 ppb for adults aged 50 years and
older. Although the surface water EEC
for rice (140 ppb) exceeds the DWLOC
for children (130 ppb), EPA does not
believe this is a cause for concern,
because the surface water estimate for
rice is considered to be a gross
overestimate of the true value found in
the environment. EPA’s careful analysis
indicates that the turf grass estimate (50
ppb) is a more realistic estimate of
drinking water residues. Thus, EPA
does not consider short-term aggregate
risk for children to exceed the Agency’s
level of concern, as shown in Table 4 of
this unit:
TABLE 4.—AGGREGATE RISK ASSESSMENT FOR SHORT-TERM EXPOSURE TO TRIFLOXYSTROBIN
Population subgroup
Aggregate MOE
(Food + Residential)
General U.S. population
690
All infants < 1 year
190
180
Children 1–2 years
150
130
Females 13–49
years
970
1,000
Adults > 50 years
950
1,200
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Concern (LOC)
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50 (turf)
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(ppb)
3.4
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6. Intermediate-term risk.
Intermediate-term aggregate exposure
takes into account non-dietary, nonoccupational exposure plus chronic
exposure to food and water (considered
to be a background exposure level). An
intermediate-term aggregate risk
assessment (1 to 6 months of exposure
to trifloxystrobin residues from food,
drinking water, and residential pesticide
uses) is not expected to occur based on
the short soil half-life of trifloxystrobin
(about 2 days). Therefore, EPA did not
perform an intermediate-term aggregate
risk assessment.
7. Aggregate cancer risk for U.S.
population. EPA has concluded that
trifloxystrobin should be classified as a
‘‘Not Likely Human Carcinogen.’’ Due to
the classification, an aggregate cancer
risk assessment was not performed.
8. Determination of safety. Based on
these risk assessments, EPA concludes
that there is a reasonable certainty that
no harm will result to the general U.S.
population, and to infants and children
from aggregate exposure to
trifloxystrobin residues.
V. Other Considerations
A. Analytical Enforcement Methodology
EPA has completed a method
validation trial of AG–659A on apples,
cow liver, cow milk, grapes, peanut hay,
peanuts, raisins, summer squash, and
wet apple pomace and concluded that
AG–659A is suitable for enforcement of
trifloxystrobin and the free form of its
acid metabolite in plant and livestock
commodities. The analytical methods,
AG–659A or AG–659A/REM 177.04, are
adequate for collecting data for residues
of trifloxystrobin and its acid metabolite
CGA–321113 in or on soybeans.
The regulable residue was tested in
accordance with the Pesticide
Analytical Manual (PAM), Volume I,
Appendix II. Trifloxystrobin gave
adequate responses through protocol C,
and was completely recovered from
fortified apple samples when analyzed
through protocols D and E. Acid
metabolite CGA–321113 was
recoverable through protocol B and
residues from apples fortified with
CGA–321113 were completely
recovered through Section 402 E2/C1
(extraction with methylene chloride).
The enforcement method has been
forwarded to the Food and Drug
Administration (FDA) for inclusion in
the PAM II.
Adequate enforcement methodology
(example—gas chromatography) is
available to enforce the tolerance
expression. The method may be
requested from: Chief, Analytical
Chemistry Branch, Environmental
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Science Center, 701 Mapes Road, Ft.
Meade, MD 20755–5350; telephone
number: (410) 305–2905; e-mail address:
residuemethods@epa.gov.
B. International Residue Limits
There are no Codex, Canadian, or
Mexican maximum residue limits
(MRLs) established for trifloxystrobin.
Harmonization is thus not an issue at
this time.
C. Conditions
There are no conditions for
registration placed on these time-limited
tolerances.
VI. Conclusion
Therefore, tolerances are established
for combined residues of trifloxystrobin,
(benzeneacetic acid, (E,E)-[alpha](methoxyimino)-2-[[[[1-[3(trifluoromethyl)
phenyl]ethylidene]amino]oxy]methyl],methylester) and the free form of its
acid metabolite CGA–321113 ((E,E)methoxyimino-[2-[1-(3trifluoromethylphenyl)
ethylideneaminooxymethyl]phenyl]acetic acid) in or on soybean,
forage at 4.0 ppm, soybean, hay at 6.5
ppm; and soybean, seed at 0.04 ppm.
VII. Objections and Hearing Requests
Under section 408(g) of FFDCA, as
amended by 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 FQPA, EPA will continue to
use those procedures, with appropriate
adjustments, until the necessary
modifications can be made. The new
section 408(g) of 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 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–2005–0155 in the subject line on
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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 August 23, 2005.
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 part
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 part 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 (1900L),
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 Suite 350, 1099 14th St., NW.,
Washington, DC 20005. 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 (202) 564–6255.
2. Copies for the Docket. In addition
to filing an objection or hearing request
with the Hearing Clerk as described in
Unit VII.A., you should also send a copy
of your request to the PIRIB for its
inclusion in the official record that is
described in ADDRESSES. Mail your
copies, identified by the docket ID
number OPP–2005–0155, 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 ADDRESSES. 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
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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).
VIII. Statutory and Executive Order
Reviews
This final rule establishes a timelimited tolerance under section 408 of
FFDCA. 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 FIFRA
section 18 exemption under section 408
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of 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.
PO 00000
Frm 00066
Fmt 4700
Sfmt 4700
Thus, Executive Order 13175 does not
apply to this rule.
IX. 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: June 17, 2005.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.555 is amended by
adding text to paragraph (b) to read as
follows:
I
§ 180.555 Trifloxystrobin; tolerances for
residues.
*
*
*
*
*
(b) *
* * Time-limited
tolerances are established for combined
residues of the fungicide trifloxystrobin,
(benzeneacetic acid, (E,E)-[alpha](methoxyimino)-2-[[[[1-[3(trifluoromethyl)phenyl]
ethylidene]amino]oxy]methyl],methylester) and the free form of its
acid metabolite CGA–321113 ((E,E)methoxyimino-[2-[1-(3trifluoromethylphenyl)
ethylideneaminooxymethyl]phenyl]acetic acid) in connection with
the use of the pesticide under FIFRA
section 18 emergency exemptions
granted by EPA. The tolerances will
expire and are revoked on the date
specified in the table in this unit.
E:\FR\FM\24JNR1.SGM
24JNR1
Federal Register / Vol. 70, No. 121 / Friday, June 24, 2005 / Rules and Regulations
On page 23752, there are three CPT
codes erroneously included in the list of
ASC covered procedures. These CPT
codes are not on the ASC list because
Soybean, forage
4.0
12/31/09
Soybean, hay ....
6.5
12/31/09 they were discontinued for 2005.
Soybean, seed ..
0.04
12/31/09 Therefore on page 23752, remove CPT
codes 50559, Renal endoscopy/
radiotracer, 50959, Ureter endoscopy
*
*
*
*
*
and tracer, and 50978, Ureter endoscopy
[FR Doc. 05–12447 Filed 6–23–05; 8:45 am]
and tracer.
BILLING CODE 6560–50–S
The final error is one of omission.
One public comment and the response
were not included in the May 4, 2005
DEPARTMENT OF HEALTH AND
interim final rule. That comment and
HUMAN SERVICES
response are as follows:
Centers for Medicare & Medicaid
Comment: We received one comment
Services
requesting that we add CPT code 55873,
Cryosurgical ablation of the prostate, to
42 CFR Part 416
the ASC list. The commenter also asked
that we assign the procedure to a newly
[CMS–1478–CN]
created payment group with a higher
RIN 0938–AN23
rate than current payment group 9. The
commenter believes that the procedure
Medicare Program; Update of
meets the criteria for inclusion on the
Ambulatory Surgical Center List of
ASC list and that adding it to the list
Covered Procedures; Correction
will permit reasonable site-of-service
AGENCY: Centers for Medicare &
flexibility for physicians.
Medicaid Services (CMS), HHS.
Response: We agree with the
ACTION: Correction of interim final rule
commenter that the procedure meets the
with comment period.
criteria for inclusion on the ASC list.
Utilization data show that the service is
SUMMARY: This document corrects
performed most of the time in the
technical errors that appeared in the
hospital outpatient setting and our
interim final rule with comment period
medical staff agreed that it is
published in the Federal Register on
appropriate for the ASC setting. We
May 4, 2005 entitled ‘‘Medicare
cannot however, create a new, higher
Program; Update of Ambulatory
payment level for this procedure
Surgical Center List of Covered
because we do not have data upon
Procedures.’’
which to base new payment rates and
DATES: Effective July 1, 2005.
because the Congress has relieved us of
FOR FURTHER INFORMATION CONTACT:
performing a new survey and has,
Dana Burley, (410) 786–0378.
instead, mandated development of a
SUPPLEMENTARY INFORMATION:
new payment system. Therefore, we
assigned the procedure to Group 9, the
I. Background
highest paying of the existing payment
In FR Doc. 05–8875 of May 4, 2005
groups under which payments for ASC
(70 FR 23690), there were several
facility services are currently made.
technical errors that are identified and
III. Waiver of Proposed Rulemaking
corrected in the Correction of Errors
section below. The provisions in this
We ordinarily publish a notice of
correction notice are effective as if they
proposed rulemaking in the Federal
had been included in the document
Register to provide a period for public
published May 4, 2005. Accordingly,
comment before the provisions of a
the corrections are effective July 1, 2005. notice take effect. We can waive this
Commodity
Parts per
million
Expiration/
revocation
date
II. Correction of Errors
In FR Doc. 05–8875 of May 4, 2005
(70 FR 23690), make the following
corrections:
On page 23690, in the first column, in
the ‘‘Effective Date’’ section, the
effective date of July 5, 2005 is an error.
Remove ‘‘July 5, 2005’’ and add in its
place ‘‘July 1, 2005.’’
On page 23710, in section IV, Waiver
of Proposed Rulemaking, in column 2,
in lines 1 and 8, remove ‘‘July 5, 2005’’
and add in its place ‘‘July 1, 2005.’’
VerDate jul<14>2003
16:42 Jun 23, 2005
Jkt 205001
procedure, however, if we find good
cause that notice and comment
procedure is impracticable,
unnecessary, or contrary to the public
interest and incorporate a statement of
the finding and the reasons for it into
the notice issued.
We find it unnecessary to undertake
notice and comment rulemaking
because this notice merely provides
technical corrections to the regulations.
Therefore, we find good cause to waive
notice and comment procedures.
PO 00000
Frm 00067
Fmt 4700
Sfmt 4700
36533
(Catalog of Federal Domestic Assistance
Program No. 93.774, Medicare—
Supplementary Medical Insurance Program)
Dated: June 20, 2005.
Ann C. Agnew,
Executive Secretary to the Department.
[FR Doc. 05–12522 Filed 6–23–05; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
50 CFR Part 300
[Docket No. 050125016–5097–02; I.D.
061605B]
Pacific Halibut Fisheries; Oregon Sport
Fisheries
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Temporary rule; inseason
adjustment; request for comments.
AGENCY:
SUMMARY: NMFS announces changes to
the regulations for the Area 2A sport
halibut fisheries off the central coast of
Oregon. This action would clarify the
halibut regulations for the central
Oregon coast sport fishery sub-area to
specify that halibut may be onboard
recreational fishing vessels trolling for
salmon within the Oregon yelloweye
rockfish conservation area (YRCA). The
purpose of this action is to allow
recreational salmon vessels to retain
halibut caught legally outside of the
YRCA while those vessels are legally
fishing for salmon within the YRCA.
DATES: Effective June 24, 2005, through
the 2006 annual management measures
which will publish in a later Federal
Register document. Comments must be
received no later than 5 p.m., local time,
on July 11, 2005.
ADDRESSES: You may submit comments,
identified by I.D. 061605B by any of the
following methods:
• E-mail:
Halibut2005inseason.nwr@noaa.gov:
Include 061605B in the subject line of
the message.
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Fax: 206–526–6736, Attn: Yvonne
deReynier
• Mail: D. Robert Lohn,
Administrator, Northwest Region,
NMFS, 7600 Sand Point Way NE,
Seattle, WA 98115–0070, Attn: Yvonne
deReynier.
E:\FR\FM\24JNR1.SGM
24JNR1
]]>Agencies
[Federal Register Volume 70, Number 121 (Friday, June 24, 2005)]
[Rules and Regulations]
[Pages 36524-36533]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-12447]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2005-0155; FRL-7720-2]
Trifloxystrobin; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a time-limited tolerance for
combined residues of trifloxystrobin in or on soybean, forage; soybean,
hay; and soybean, seed. This action is in response to EPA's granting of
an emergency exemption under section 18 of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide
on soybeans. This regulation establishes a maximum permissible level
for residues of trifloxystrobin in this food commodity. The tolerances
will expire and are revoked on December 31, 2009.
DATES: This regulation is effective June 24, 2005. Objections and
requests for hearings must be received on or before August 23, 2005.
ADDRESSES: To submit a written objection or hearing request follow the
[[Page 36525]]
detailed instructions as provided in Unit VII. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under docket
identification (ID) number OPP-2005-0155. All documents in the docket
are listed in the EDOCKET index at https://www.epa.gov/edocket/.
Although listed in the index, some information is not publicly
available, i.e., Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either electronically in
EDOCKET or in hard copy at the Public Information and Records Integrity
Branch (PIRIB), Room 119, Crystal Mall 2, 1801 S. Bell St.,
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.
FOR FURTHER INFORMATION CONTACT: Carmen Rodia, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 306-0327; fax number: (703) 308-5433; e-mail address:
rodia.carmen@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
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 Access Electronic Copies of this Document and Other
Related Information?
In addition to using EDOCKET (https://www.epa.gov/edocket/), you may
access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at https://www.epa.gov/
fedrgstr/. A frequently updated electronic version of 40 CFR part 180
is available on E-CFR Beta Site Two at https://www.gpoaccess.gov/ecfr/.
II. Background and Statutory Findings
EPA, on its own initiative, in accordance with sections 408(e) and
408 (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, is establishing a tolerance for combined residues of the
fungicide trifloxystrobin, (benzeneacetic acid, (E,E)-[alpha]-
(methoxyimino)-2-[[[[1-[3-(trifluoromethyl)phenyl] ethylidene]
amino]oxy]methyl]-,methylester) and the free form of its acid
metabolite CGA-321113 ((E,E)-methoxyimino-[2-[1-(3-
trifluoromethylphenyl) ethylideneaminooxymethyl]-phenyl] acetic acid)
in or on soybean, forage at 4.0 parts per million (ppm); soybean, hay
at 6.5 ppm; and soybean, seed at 0.04 ppm. These tolerances will expire
and are revoked on December 31, 2009. EPA will publish a document in
the Federal Register to remove the revoked tolerances from the Code of
Federal Regulations (CFR).
Section 408(l)(6) of FFDCA requires EPA to establish a time-limited
tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
FIFRA section 18 related tolerances to set binding precedents for the
application of section 408 of FFDCA and the new safety standard to
other tolerances and exemptions. Section 408(e) of FFDCA allows EPA to
establish a tolerance or an exemption from the requirement of a
tolerance on its own initiative, i.e., without having received any
petition from an outside party.
Section 408(b)(2)(A)(i) of 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 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 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. . .
.''
Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' This provision was not
amended by the Food Quality Protection Act of 1996 (FQPA). EPA has
established regulations governing such emergency exemptions in 40 CFR
part 166.
III. Emergency Exemption for Trifloxystrobin on Soybeans and FFDCA
Tolerances
Multiple States throughout the United States have petitioned the
Agency requesting an emergency exemption for use of trifloxystrobin to
control soybean rust under the provisions of section 18 of FIFRA. The
soybean rust pathogen (Phakopsora pachyrhizi) was recently identified
in the continental United States. Soybean rust has been designated as a
biosecurity threat by action of the U.S. Congress and; therefore, it is
important that control measures be available to soybean growers in the
United States. Accordingly, EPA has expedited review under section 18
of FIFRA to authorize the use of trifloxystrobin on soybeans for
control of soybean rust for requesting states in the United States,
having concluded that emergency conditions exist regarding this
chemical use.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of trifloxystrobin in or on
soybeans. In doing so, EPA considered the safety standard in section
408(b)(2) of FFDCA, and EPA decided that the necessary tolerance under
section 408(l)(6) of FFDCA would be consistent with the safety standard
and with section 18 of FIFRA. Consistent with the need to move quickly
on the emergency exemption in order to address an urgent non-routine
situation and to ensure that the resulting food is safe and lawful, EPA
is issuing this tolerance without notice and opportunity for public
[[Page 36526]]
comment as provided in section 408(l)(6) of FFDCA. Although these
tolerances will expire and are revoked on December 13, 2009, under
section 408(l)(5) of FFDCA, residues of the pesticide not in excess of
the amounts specified in the tolerance remaining in or on poultry,
soybeans, or swine after that date will not be unlawful, provided the
pesticide is applied in a manner that was lawful under FIFRA, and the
residues do not exceed a level that was authorized by these tolerances
at the time of that application. EPA will take action to revoke these
tolerances earlier if any experience with, scientific data on, or other
relevant information on this pesticide indicate that the residues are
not safe.
Because these tolerances are being approved under emergency
conditions, EPA has not made any decisions about whether
trifloxystrobin meets EPA's registration requirements for use on
soybeans or whether a permanent tolerance for this use would be
appropriate. Under these circumstances, EPA does not believe that these
tolerances serve as a basis for registration of trifloxystrobin by a
State for special local needs under section 24(c) of FIFRA. Nor do
these tolerances serve as the basis for any State that has not been
specifically authorized by EPA to use this pesticide on this crop under
section 18 of FIFRA without following all provisions of EPA's
regulations implementing section 18 of FIFRA as identified in 40 CFR
part 166. For additional information regarding the emergency exemption
for trifloxystrobin, contact the Agency's Registration Division at the
address provided under FOR FURTHER INFORMATION CONTACT.
IV. Aggregate Risk Assessment and Determination of Safety
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 FFDCA and a complete
description of the risk assessment process, see the final rule on
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).
Consistent with section 408(b)(2)(D) of 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
trifloxystrobin and to make a determination on aggregate exposure,
consistent with section 408(b)(2) of FFDCA, for a time-limited
tolerance for combined residues of trifloxystrobin in or on soybean,
forage at 4.0 ppm; soybean, hay at 6.5 ppm; and soybean, seed at 0.04
ppm. EPA's assessment of the dietary exposures and risks associated
with establishing the tolerance follows.
A. Toxicological Endpoints
The dose at which no adverse effects are observed (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological endpoint. 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 intra species differences.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is
retained due to concerns over risk to children's health, 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
Safety Factor (SF).
For non-dietary risk assessments (other than cancer) the UF is used
to determine the level of concern (LOC). For example, when 100 is the
appropriate UF (10x to account for interspecies differences and 10x for
intraspecies differences) the LOC is 100. To estimate risk, a ratio of
the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is
calculated and compared to the LOC.
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 x10-\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 trifloxystrobin used for human risk assessment is shown
in Table 1 of this unit:
[[Page 36527]]
Table 1.--Summary of Toxicological Dose and Endpoints for Trifloxystrobin for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
FQPA SF* and level of
Exposure/scenario Dose used in risk concern for risk Study and toxicological
assessment, UF assessment effects
----------------------------------------------------------------------------------------------------------------
Acute dietary NOAEL = 250 milligram/ FQPA SF = 1x Developmental toxicity--
(Females 13-49 years of age)......... kilogram/day (mg/kg/ aPAD = acute RfD/FQPA rat
day) SF = 2.5 mg/kg/day. LOAEL = 500 mg/kg/day
UF = 100.............. based on increased
Acute RfD = 2.5 mg/kg/ fetal skeletal
day. anomalies.
----------------------------------------------------------------------------------------------------------------
Acute Dietary There were no appropriate toxicological effects attributable to a single
(General U.S. population, including exposure (dose) observed in oral toxicity studies including maternal
infants and children). effects in developmental studies in rats and rabbits. Therefore, a dose
and endpoint were not identified for this risk assessment.
----------------------------------------------------------------------------------------------------------------
Chronic dietary Parental NOAEL = 3.8 mg/ FQPA SF = 1x 2-Generation
(All populations).................... kg/day cPAD = chronic RfD/FQPA reproduction study--
UF = 100.............. SF = 0.038 mg/kg/day. rat
Chronic RfD = 0.038 mg/ LOAEL = 55.3 mg/kg/day
kg/day. based on decreases in
body weight, body
weight gains, reduced
food consumption, and
histopathological
lesions in the liver,
kidneys, and spleen.
----------------------------------------------------------------------------------------------------------------
Short- (1 to 30 days) and Offspring NOAEL = 3.8 LOC for MOE = 100 2-Generation
intermediate-term (1-6 months) mg/kg/day (residential, includes reproduction study--
Oral................................. FQPA SF). rat
LOAEL = 55.3 mg/kg/day
based on reduced pup
body weights during
lactation.
----------------------------------------------------------------------------------------------------------------
Short- (1 to 30 days) and Dermal study NOAEL = LOC for MOE = 100 28-Day dermal toxicity
intermediate-term (1-6 months) 100 mg/kg/day (occupational)......... study--rat
Dermal............................... LOC for MOE = 100...... LOAEL = 1,000 mg/kg/day
(residential, includes based on increases in
FQPA SF). mean absolute and
relative liver and
kidney weights.
----------------------------------------------------------------------------------------------------------------
Long-term (> 6 months) Oral study NOAEL = 3.8 LOC for MOE = 100 2-Generation
Dermal............................... mg/kg/day (occupational)......... reproduction study--
(dermal absorption rate LOC for MOE = 100...... rat
= 33%). (residential, includes LOAEL = 55.3 mg/kg/day
FQPA SF). based on decreases in
body weight, body
weight gains, reduced
food consumption, and
histopathological
lesions in the liver,
kidneys, and spleen.
----------------------------------------------------------------------------------------------------------------
Short- (1 to 30 days), intermediate- Oral study NOAEL = 3.8 LOC for MOE = 100 2-Generation
(1-6 months), and long-term (> 6 mg/kg/day (occupational)......... reproduction study--
months) (inhalation absorption LOC for MOE = 100...... rat
Inhalation........................... rate = 100%). (residential, includes LOAEL = 55.3 mg/kg/day
FQPA SF). based on decreases in
body weight, body
weight gains, reduced
food consumption, and
histopathological
lesions in the liver,
kidneys, and spleen.
----------------------------------------------------------------------------------------------------------------
Cancer Classification: ``Not Likely Human Carcinogen,'' based on the lack of
(Oral, dermal, and inhalation)....... evidence of carcinogenicity in mouse and rat cancer studies.
----------------------------------------------------------------------------------------------------------------
* The reference to the FQPA SF refers to any additional SF retained due to concerns unique to FQPA.
B. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.555) for the combined residues of
trifloxystrobin, in or on a variety of raw agricultural commodities
(RACs). Specifically, tolerances for almonds, barley, carrots, celery,
citrus, field corn, fruiting vegetables, hops, pecans, potatoes, rice,
stone fruits, sugar beets, and wheat. Risk assessments were conducted
by EPA to assess dietary exposures from trifloxystrobin in food as
follows:
i. Acute exposure. Acute dietary (food only) exposure 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. The Dietary Exposure Evaluation Model
software with the Food Commodity Intake Database (DEEM-FCID\TM\),
Version 1.3, which incorporates the individual food consumption data as
reported by respondents in the United States Department of Agriculture
(USDA) 1994-1996 and 1998 nationwide Continuing Surveys of Food Intake
by Individuals (CSFII) and accumulated exposure to the chemical for
each commodity. The acute dietary (food only) exposure analysis for
trifloxystrobin is unrefined, assuming 100% crop treated and tolerance
level residues. No additional data were used to refine the analysis.
The acute dietary endpoint is applicable to the population subgroup
females, 13-49 years only. An acute dietary endpoint for the general
U.S. population, including infants and children, was not identified.
The estimated dietary (food only) exposure for females, 13-49 years old
occupies less than 1% of the aPAD and does not exceed EPA's level of
concern.
ii. Chronic exposure. In conducting this chronic dietary (food
only) exposure assessment, EPA used the DEEM-FCID\TM\ software,
incorporating the individual food consumption data as reported by
respondents in the USDA 1994-1996 and 1998 CSFII and accumulated
exposure to the chemical for each commodity. The chronic dietary (food
only) exposure analysis for trifloxystrobin is unrefined, assuming 100%
crop treated and tolerance level residues. The chronic dietary endpoint
applies to all population subgroups, including infants and children.
Risk
[[Page 36528]]
estimates for all population subgroups are below EPA's level of concern
(100% of the cPAD).
iii. Cancer. EPA's previous reviews of data (May 1999) related to
trifloxystrobin have determined that trifloxystrobin should be
classified as a ``Not Likely Human Carcinogen.'' Accordingly, no
additional cancer risk assessment was performed for trifloxystrobin.
iv. Anticipated residue and percent crop treated (PCT) information.
Established and recommended tolerances were used in the acute and
chronic dietary (food only) exposure assessments for trifloxystrobin.
The metabolite L7a (taurine conjugate of trifloxystrobin) was also
included in the exposure assessment for liver, based on the amount
found in the ruminant metabolism study. EPA did not apply PCT data for
this assessment. DEEM-FCID\TM\ default concentration factors were used
except for tomato juice, puree, paste, and catsup. Processing data show
no concentration in these fractions.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for trifloxystrobin in drinking
water. Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the physical
characteristics of trifloxystrobin.
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 modeling system (SCI-GROW)
is used to predict pesticide concentrations in shallow ground water.
For a screening-level assessment for surface water, EPA will generally
use FIRST (a tier 2 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 %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 trifloxystrobin, they are
further discussed in Unit IV.D., aggregate risk.
Based on the PRZM/EXAMS and SCI-GROW models, the EECs of
trifloxystrobin for acute exposures are estimated to be 48 parts per
billion (ppb) for surface water and 3.4 ppb for ground water. The EECs
for chronic exposures are estimated to be 140 ppb for surface water and
3.4 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).
Trifloxystrobin is currently registered for use in turf grass and
ornamentals. No new residential uses are proposed in this action.
Because FQPA requires consideration of aggregate exposure to all likely
non-occupational uses, this assessment uses non-occupational post-
application contact with trifloxystrobin following potential use on
turf grass as the most common and worst case contributor to such
exposures. The current registered use of trifloxystrobin on turf grass
and ornamentals may only be applied by a Certified Pest Control
Operator (PCO); therefore, an assessment of dermal or inhalation
exposure for residential handlers is not required and was not
performed.
EPA calculated MOEs for exposure scenarios involving potential
residential exposure resulting from the currently registered uses of
the chemical. The lowest MOE was 800 for children resulting from direct
dermal contact with treated lawns (this represents the exposure
scenario with the highest exposure; conversely, the adult dermal MOE
was 1,300). The highest MOE for children was 220,000 from ingestion of
soil from treated lawns. All calculated non-occupational post-
application MOEs are greater than 100 on the day of application and;
therefore, did not exceed EPA's level of concern.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of 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.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to trifloxystrobin and any
other substances and trifloxystrobin 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 trifloxystrobin
has a common mechanism of toxicity with other substances. For
information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see the policy statements released by EPA's OPP
concerning common mechanism determinations and procedures for
cumulating effects from substances found to have a common mechanism on
EPA's website at https://www.epa.gov/pesticides/cumulative/.
C. Safety Factor for Infants and Children
1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional ten-fold margin of safety for infants and children in the
case of threshold effects to account for prenatal and post-natal
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 an MOE
analysis or through using UFs in calculating a dose level that poses no
appreciable risk to humans.
2. Discussion. There is no indication of an increased
susceptibility of rat or rabbit fetuses/pups to pre- and/or post-natal
exposure to trifloxystrobin. In the developmental and reproduction
[[Page 36529]]
toxicity studies, effects in the fetuses/pups were observed only at or
above treatment levels, which resulted in evidence of parental
toxicity. As a result, the Agency determined that a developmental
neurotoxicity (DNT) study in rats is not required.
The acute and chronic dietary (food only) exposure assessments
utilize existing and proposed tolerance level residues and 100% crop
treated information for all commodities. By using these screening-level
assessments, actual exposures/risks will not be underestimated.
Additionally, the exposure assessments will not underestimate the
potential dietary (food and drinking water) or non-dietary exposures
for infants and children from the use of trifloxystrobin.
The dietary drinking water assessment utilizes water concentration
values generated by model and associated modeling parameters, which are
designed to provide conservative, health protective, high-end estimates
of water concentrations, which are not likely to be exceeded. The
residential post-application assessment is based upon the residential
standard operating procedures (SOPs) and is based upon surrogate study
data. These data are reliable and are not expected to underestimate
risk to adults or children. The residential SOPs are based upon
reasonable ``worst-case'' assumptions and are not expected to
underestimate risk.
3. Conclusion. EPA has evaluated the potential for increased
susceptibility of infants and children from exposure to
trifloxystrobin. There is a complete toxicity data base for
trifloxystrobin and exposure data are complete or are estimated based
on data that reasonably accounts for potential exposures. The Agency
has concluded that there are no residual uncertainties for pre- and/or
post-natal toxicity. Further, based on existing hazard data and the
quality of exposure data for trifloxystrobin, EPA has determined that
traditional 10x safety factors are adequately protective for all
populations, and the special FQPA SF need not be applied (e.g., it has
been reduced from 10x to 1x).
D. Aggregate Risks and Determination of Safety
1. General discussion. 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 + chronic non-dietary, non-
occupational exposure)]. This allowable exposure through drinking water
is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the EPA's 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 body weights and drinking water consumption
values vary on an individual basis. This variation will be taken into
account in more refined screening-level and quantitative drinking water
exposure assessments. Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
Acute, short-term, intermediate-term, chronic, and cancer.
When EECs for surface water and ground water are less than the
calculated DWLOCs, EPA concludes with reasonable certainty that
exposures to trifloxystrobin 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 trifloxystrobin on drinking water as a part of the aggregate risk
assessment process.
2. Summary of aggregate risk analysis. Acute and chronic aggregate
risk estimates were calculated in this risk assessment. Acute aggregate
risk was calculated by comparing acute DWLOCs to potential drinking
water exposure to trifloxystrobin. Similarly, chronic aggregate risk
was calculated by comparing chronic DWLOCs to potential drinking water
exposure. The surface and ground water EECs were used to compare
against back-calculated DWLOCs for aggregate risk assessments.
Short-term risk is based on exposures occurring over 1 to 30 days.
Short-term aggregate risk was calculated by combining risk estimates
for high-end residential oral and/or dermal exposures with chronic food
and drinking water risks. Intermediate-term exposure (1 to 6 months) to
the parent trifloxystrobin is not expected to occur in residential
settings due to its short half-life (about 2 days based on soil and
aquatic metabolism studies). Therefore, an intermediate-term aggregate
risk assessment was not performed. Chronic non-dietary aggregate risk
was not calculated as chronic dermal and oral exposures (from
residential treatment) are not expected. Cancer aggregate risk was not
calculated because trifloxystrobin has been classified as a ``not
likely human carcinogen.''
Acute, short-term and chronic aggregate risk estimates resulting
from aggregate exposure to trifloxystrobin in food and drinking water
were assessed, and are below EPA's level of concern.
3. Acute risk. The acute aggregate risk assessment takes into
account exposure estimates from dietary consumption of trifloxystrobin
from food and drinking water sources. Acute aggregate risk was not
calculated for the general U.S. population (including infants and
children or other population subgroups) as hazard endpoints have not
been identified for those groups.
The acute risk estimate for females, 13-49 years, resulting from
aggregate exposure to trifloxystrobin in food and drinking water, is
below EPA's level of concern. DWLOCs were calculated for females 13-49
years, the only subgroup to which the acute dietary endpoint applies.
Surface and ground water EECs were used to compare against back-
calculated DWLOCs for aggregate risk assessments. To calculate the
DWLOC for acute exposure relative to an acute toxicity endpoint, the
acute dietary food exposure (from DEEM-FCID\TM\) was subtracted from
the aPAD to obtain the acceptable acute exposure to trifloxystrobin in
drinking water.
The DWLOC was 75,000 ppb for females, 13-49 years, a value that is
well above the EECs for drinking water. Therefore, acute aggregate risk
is below EPA's level of concern. EPA does not expect the aggregate
exposure to exceed 100% of the aPAD, as shown in Table 2 of this unit:
[[Page 36530]]
Table 2.--Aggregate Risk Assessment for Acute Exposure to Trifloxystrobin
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population subgroup aPAD (mg/ % aPAD Water EEC Water EEC Acute DWLOC
kg/day) (Food) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
Females 13-49 years 2.5 < 1 92 (turf) 3.4 75,000
48 (rice)
----------------------------------------------------------------------------------------------------------------
4. Chronic risk. For the chronic aggregate risk scenario, potential
food and drinking water exposures were analyzed. Chronic exposure in
residential settings is not expected. The surface and ground water EECs
were used to compare against back-calculated DWLOCs for aggregate risk
assessments. To calculate DWLOCs for chronic exposure relative to an
chronic toxicity endpoint, the chronic dietary food exposure (from
DEEM-FCID\TM\) was subtracted from the cPAD to obtain the acceptable
chronic exposure to trifloxystrobin in drinking water.
DWLOCs were calculated for the general U.S. population, children
aged 1-2 years, females aged 13-49 years and adults aged 50 years and
older. DWLOCs ranged from 170 ppb for children to 1,200 ppb for adults
aged 50 years and older. These values are above the EECs for drinking
water. Therefore, chronic aggregate risk is below EPA's level of
concern. EPA does not expect the aggregate exposure to exceed 100% of
the cPAD, as shown in Table 3 of this unit:
Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Trifloxystrobin
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population subgroup cPAD (mg/ % cPAD Water EEC Water EEC Chronic
kg/day) (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
General U.S. population 0.038 15 140 (rice) 3.4 1,100
50 (turf)
------------------------------------------------ ------------- ------------
Children 1-2 years 54 170
----------------------------------------------------------------------------------------------------------------
5. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Though residential
exposure could occur with the use of trifloxystrobin, the potential
short-term exposures were not aggregated with chronic dietary food and
water exposures because the toxic effects are different. Different
endpoints have been identified for short-term incidental oral and
dermal risk assessment (the basis for the oral endpoint is reduced pup
body weights and the dermal endpoint is based on increases in liver and
kidney weights). Therefore, based on the best available data and
current policies, potential risks do not exceed EPA's level of concern.
A short-term risk assessment was not required for adults, because
no incidental oral exposure is expected for adults. A short-term risk
assessment was performed for infants and children because of
residential post-application oral exposure scenarios. Incidental oral
exposure for toddlers is assumed to include hand-to-mouth exposure,
object-to-mouth exposure and exposure through incidental ingestion of
soil.
DWLOCs were calculated for the general U.S. population, children
aged 1-2 years, females aged 13-49 years and adults 50 years and older.
DWLOCs ranged from 130 ppb for children to 1,200 ppb for adults aged 50
years and older. Although the surface water EEC for rice (140 ppb)
exceeds the DWLOC for children (130 ppb), EPA does not believe this is
a cause for concern, because the surface water estimate for rice is
considered to be a gross overestimate of the true value found in the
environment. EPA's careful analysis indicates that the turf grass
estimate (50 ppb) is a more realistic estimate of drinking water
residues. Thus, EPA does not consider short-term aggregate risk for
children to exceed the Agency's level of concern, as shown in Table 4
of this unit:
Table 4.--Aggregate Risk Assessment for Short-Term Exposure to Trifloxystrobin
--------------------------------------------------------------------------------------------------------------------------------------------------------
Aggregate MOE (Food + Aggregate Level of Surface Water EEC Ground Water EEC Short-Term DWLOC
Population subgroup Residential) Concern (LOC) (ppb) (ppb) (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
General U.S. population 690 100 140 (rice) 3.4 1,100
50 (turf)............
------------------------------------------------------------ ----------------------
All infants < 1 year 190 180
------------------------------------------------------------ ----------------------
Children 1-2 years 150 130
------------------------------------------------------------ ----------------------
Females 13-49 years 970 1,000
------------------------------------------------------------ ----------------------
Adults > 50 years 950 1,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 36531]]
6. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account non-dietary, non-occupational exposure plus chronic
exposure to food and water (considered to be a background exposure
level). An intermediate-term aggregate risk assessment (1 to 6 months
of exposure to trifloxystrobin residues from food, drinking water, and
residential pesticide uses) is not expected to occur based on the short
soil half-life of trifloxystrobin (about 2 days). Therefore, EPA did
not perform an intermediate-term aggregate risk assessment.
7. Aggregate cancer risk for U.S. population. EPA has concluded
that trifloxystrobin should be classified as a ``Not Likely Human
Carcinogen.'' Due to the classification, an aggregate cancer risk
assessment was not performed.
8. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general U.S. population, and to infants and children from
aggregate exposure to trifloxystrobin residues.
V. Other Considerations
A. Analytical Enforcement Methodology
EPA has completed a method validation trial of AG-659A on apples,
cow liver, cow milk, grapes, peanut hay, peanuts, raisins, summer
squash, and wet apple pomace and concluded that AG-659A is suitable for
enforcement of trifloxystrobin and the free form of its acid metabolite
in plant and livestock commodities. The analytical methods, AG-659A or
AG-659A/REM 177.04, are adequate for collecting data for residues of
trifloxystrobin and its acid metabolite CGA-321113 in or on soybeans.
The regulable residue was tested in accordance with the Pesticide
Analytical Manual (PAM), Volume I, Appendix II. Trifloxystrobin gave
adequate responses through protocol C, and was completely recovered
from fortified apple samples when analyzed through protocols D and E.
Acid metabolite CGA-321113 was recoverable through protocol B and
residues from apples fortified with CGA-321113 were completely
recovered through Section 402 E2/C1 (extraction with methylene
chloride). The enforcement method has been forwarded to the Food and
Drug Administration (FDA) for inclusion in the PAM II.
Adequate enforcement methodology (example--gas chromatography) is
available to enforce the tolerance expression. The method may be
requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Road, Ft. Meade, MD 20755-5350; telephone
number: (410) 305-2905; e-mail address: residuemethods@epa.gov.
B. International Residue Limits
There are no Codex, Canadian, or Mexican maximum residue limits
(MRLs) established for trifloxystrobin. Harmonization is thus not an
issue at this time.
C. Conditions
There are no conditions for registration placed on these time-
limited tolerances.
VI. Conclusion
Therefore, tolerances are established for combined residues of
trifloxystrobin, (benzeneacetic acid, (E,E)-[alpha]-(methoxyimino)-2-
[[[[1-[3-(trifluoromethyl) phenyl]ethylidene]amino]oxy]methyl]-
,methylester) and the free form of its acid metabolite CGA-321113
((E,E)-methoxyimino-[2-[1-(3-trifluoromethylphenyl)
ethylideneaminooxymethyl]-phenyl]acetic acid) in or on soybean, forage
at 4.0 ppm, soybean, hay at 6.5 ppm; and soybean, seed at 0.04 ppm.
VII. Objections and Hearing Requests
Under section 408(g) of FFDCA, as amended by 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 FQPA,
EPA will continue to use those procedures, with appropriate
adjustments, until the necessary modifications can be made. The new
section 408(g) of 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 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-2005-0155 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 August
23, 2005.
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 part 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 part
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 (1900L),
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 Suite 350, 1099 14\th\ St., NW.,
Washington, DC 20005. 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 (202) 564-6255.
2. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VII.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in ADDRESSES. Mail your
copies, identified by the docket ID number OPP-2005-0155, 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 ADDRESSES. 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
[[Page 36532]]
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).
VIII. Statutory and Executive Order Reviews
This final rule establishes a time-limited tolerance under section
408 of FFDCA. 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 FIFRA
section 18 exemption under section 408 of 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.
IX. 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: June 17, 2005.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.555 is amended by adding text to paragraph (b) to read
as follows:
Sec. 180.555 Trifloxystrobin; tolerances for residues.
* * * * *
(b) * * * Time-limited tolerances are established for combined
residues of the fungicide trifloxystrobin, (benzeneacetic acid, (E,E)-
[alpha]-(methoxyimino)-2-[[[[1-[3- (trifluoromethyl)phenyl]
ethylidene]amino] oxy]methyl]-,methylester) and the free form of its
acid metabolite CGA-321113 ((E,E)-methoxyimino-[2-[1-(3-
trifluoromethylphenyl) ethylideneaminooxymethyl]-phenyl]acetic acid) in
connection with the use of the pesticide under FIFRA section 18
emergency exemptions granted by EPA. The tolerances will expire and are
revoked on the date specified in the table in this unit.
[[Page 36533]]
------------------------------------------------------------------------
Expiration/
Commodity Parts per revocation
million date
------------------------------------------------------------------------
Soybean, forage............................... 4.0 12/31/09
Soybean, hay.................................. 6.5 12/31/09
Soybean, seed................................. 0.04 12/31/09
------------------------------------------------------------------------
* * * * *
[FR Doc. 05-12447 Filed 6-23-05; 8:45 am]
BILLING CODE 6560-50-S
