Fluoxastrobin; Pesticide Tolerances, 67108-67114 [E9-30039]
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67108
Federal Register / Vol. 74, No. 242 / Friday, December 18, 2009 / Rules and Regulations
modified carrot, roots from 0.7 ppm to
0.45 ppm; celeriac, tops from 0.05 ppm
to 0.20 ppm; cilantro, leaves from 4.0
ppm to 3.5 ppm; coriander, dried leaves
from 15.0 ppm to 9.0 ppm; parsley,
leaves from 0.7 ppm to 0.60 ppm. EPA
revised these tolerance levels based on
analysis of the residue field trial data
using the Agency’s tolerance
spreadsheet in accordance with the
Agency’s Guidance for Setting Pesticide
Tolerances Based on Field Trial Data.
EPA also revised the commodity term
for cilantro dried to coriander, dried
leaves, to be in compliance with correct
commodity definition. Additionally,
EPA determined that a tolerance is
required for parsley, dried leaves at 1.5
ppm. Additionally, the tolerance for
celery is removed since it is included in
the leaf petioles subgroup 4B and the
regional tolerance for parsley leaves is
removed since it is superseded by the
tolerance established in this action.
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V. Conclusion
Therefore, tolerances are established
for residues of prometryn, 2,4bis(isopropylamino)-6-methylthio-striazine, in or on celeriac, roots at 0.05
ppm; celeriac, tops at 0.20 ppm;
cilantro, leaves at 3.5 ppm; coriander,
dried leaves at 9.0 ppm; leaf petioles
subgroup 4B at 0.50 ppm; okra at 0.05
ppm; parsley, leaves at 0.60 ppm;
parsley, dried leaves at 1.5 ppm and
increases the tolerance level for carrot,
root to 0.45 ppm. Additionally, the
tolerance for celery is removed since it
is included in the leafy petioles
subgroup 4B and the regional tolerance
for parsley leaves is removed since it is
superseded by the tolerance established
in this action.
VI. Statutory and Executive Order
Reviews
This final rule establishes tolerances
under section 408(d) of FFDCA in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled Regulatory
Planning and Review (58 FR 51735,
October 4, 1993). Because this final rule
has been exempted from review under
Executive Order 12866, this final rule is
not subject to Executive Order 13211,
entitled Actions Concerning Regulations
That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001) or Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
This final rule does not contain any
information collections subject to OMB
approval under the Paperwork
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Reduction Act (PRA), 44 U.S.C. 3501 et
seq., 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).
Since tolerances and exemptions that
are established on the basis of a petition
under section 408(d) 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.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply
to this final rule. In addition, this final
rule does not 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).
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).
VII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report 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
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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: December 8, 2009.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
■
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.222, in the table to
paragraph (a) by revising the entry for
‘‘carrot, roots’’; by removing footnote 1,
and the entry for ‘‘celery,’’ and by
adding alphabetically entries for
‘‘celeriac, roots’’; ‘‘celeriac, tops’’;
‘‘cilantro, leaves’’; ‘‘coriander, dried
leaves’’; ‘‘leaf petioles subgroup 4B’’;
‘‘okra’’; ‘‘parsley, leaves’’; and ‘‘parsley,
dried leaves’’ to read as follows, and in
the table to paragraph (c) by removing
the entry for ‘‘parsley, leaves.’’
■
§ 180.222 Prometryn; tolerances for
residues.
(a) *
*
*
Commodity
Parts per million
Carrot, roots ....................
Celeriac, roots ................
Celeriac, tops ..................
Cilantro, leaves ...............
Coriander, dried leaves ..
*
*
*
Leaf petioles subgroup
4B ................................
Okra ................................
Parsley, dried leaves ......
Parsley, leaves ...............
*
*
*
*
*
*
*
0.45
0.05
0.20
3.5
9.0
*
*
0.50
0.05
1.5
0.60
*
*
*
[FR Doc. E9–30040 Filed 12–17–09; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2008–0704; FRL–8803–4]
Fluoxastrobin; Pesticide Tolerances
AGENCY: Environmental Protection
Agency (EPA).
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Federal Register / Vol. 74, No. 242 / Friday, December 18, 2009 / Rules and Regulations
ACTION:
Final rule.
SUMMARY: This regulation establishes
tolerances for combined residues of
fluoxastrobin and its Z isomer in or on
berry, low growing, subgroup 13-07G;
corn, field, grain; corn, field, forage;
corn, field, stover; soybean, forage;
soybean, hay; soybean, hulls; soybean,
seed; and aspirated grain fractions.
Arysta LifeScience North America, LLC
requested these tolerances under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
DATES: This regulation is effective
December 18, 2009. Objections and
requests for hearings must be received
on or before February 16, 2010, and
must be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2008–0704. All documents in the
docket are listed in the docket index
available at https://www.regulations.gov.
Although listed in the index, some
information is not publicly available,
e.g., 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 in the electronic docket at
https://www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S–
4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The
Docket Facility is open from 8:30 a.m.
to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket
Facility telephone number is (703) 305–
5805.
FOR FURTHER INFORMATION CONTACT: John
Bazuin, Registration Division, Office of
Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460–
0001; telephone number: (703) 305–
7381; e-mail address:
bazuin.john@epa.gov.
SUPPLEMENTARY INFORMATION:
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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
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not limited to those engaged in the
following activities:
• 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 to provide 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?
In addition to accessing electronically
available documents at https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr. You may
also access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
cite at https://www.gpoaccess.gov/ecfr.
To access the OPPTS harmonized test
guidelines referenced in this document
electronically, please go to https://
www.epa.gov/oppts and select ‘‘Test
Methods & Guidelines’’ on the left-side
navigation menu.
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of FFDCA, 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2008–0704 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
as required by 40 CFR part 178 on or
before February 16, 2010.
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing that does not
contain any CBI for inclusion in the
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public docket that is described in
Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit this copy,
identified by docket ID number EPA–
HQ–OPP–2008–0704, by one of the
following methods:
• Federal eRulemaking Portal https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries
are only accepted during the Docket
Facility’s normal hours of operation
(8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays).
Special arrangements should be made
for deliveries of boxed information. The
Docket Facility telephone number is
(703) 305–5805.
ADDRESSES.
II. Petition for Tolerance
In the Federal Register of December 3,
2008 (73 FR 73640) (FRL–8390–4), EPA
issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition (PP 8F7437) by Arysta
LifeScience North America, LLC, 15401
Weston Parkway, Suite 150, Cary, NC
27513. The petition requested that 40
CFR 180.609 be amended by
establishing tolerances for combined
residues of the fungicide fluoxastrobin,
(1E)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4pyrimidinyl]oxy]phenyl](5,6-dihydro1,4,2-dioxazin-3-yl)methanone Omethyloxime and its Z isomer, (1Z)-[2[[6-(2-chlorophenoxy)-5-fluoro-4pyrimidinyl]oxy]phenyl](5,6-dihydro1,4,2-dioxazin-3-yl)methanone Omethyloxime, in or on corn, field, grain
at 0.02 parts per million (ppm); corn,
field, aspirated grain fractions at 0.50
ppm; corn, field, forage at 3.0 ppm;
corn, field, fodder/stover at 4.5 ppm;
soybean, seed at 0.05 ppm; soybean,
aspirated grain fractions at 0.40 ppm;
soybean, forage at 9.0 ppm; soybean,
hay at 1.2 ppm; and soybean, hulls at
0.40 ppm.
Also in the Federal Register of
December 3, 2008 (73 FR 73644) (FRL–
8386–9), EPA issued a notice pursuant
to section 408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
another pesticide petition (PP 8F7406)
by Arysta LifeScience North America,
LLC. The petition requested that 40 CFR
180.609 be amended by establishing
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tolerances for the combined residues of
the fungicide fluoxastrobin, (1E)-[2-[[6(2-chlorophenoxy)-5-fluoro-4pyrimidinyl]oxy]phenyl](5,6-dihydro1,4,2-dioxazin-3-yl)methanone Omethyloxime and its Z isomer, (1Z)-[2[[6-(2-chlorophenoxy)-5-fluoro-4pyrimidinyl]oxy]phenyl](5,6-dihydro1,4,2-dioxazin-3-yl)methanone Omethyloxime , in or on low growing
berries (crop subgroup 13-07G) at 1.9
ppm. Each notice referenced a summary
of the appropriate petition which had
been prepared by Arysta LifeScience
North America, LLC, the registrant, and
is available to the public in the docket,
https://www.regulations.gov. There were
no comments received in response to
the notice of filing.
Based upon review of the data
supporting the petition, EPA has
corrected the commodity and subgroup
names, and replaced ‘‘corn, field,
aspirated grain fractions’’ and
‘‘soybeans, aspirated grain fractions’’
with ‘‘aspirated grain fractions.’’ EPA
has also substantially increased the
tolerance for aspirated grain fractions
and decreased the tolerance for soybean,
hulls. The reasons for these changes are
explained in Unit IV.C.
III. Aggregate Risk Assessment and
Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal upper 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....’’
Consistent with section 408(b)(2)(D)
of FFDCA, and the factors specified in
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
and to make a determination on
aggregate exposure for the petitioned-for
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tolerances for the combined residues of
fluoxastrobin and its Z isomer in or on
aspirated grain fractions at 20 ppm;
berry, low growing, subgroup 13-07G at
1.9 ppm; corn, field, forage at 3.0 ppm;
corn, field grain at 0.02 ppm; corn, field,
stover at 4.5 ppm; soybean, forage at 9.0
ppm; soybean, hay at 1.2 ppm; soybean,
hulls at 0.20 ppm; soybean, seed at 0.05
ppm. EPA’s assessment of exposures
and risks associated with establishing
tolerances follows.
A. Toxicological Profile
EPA has evaluated the available
toxicity data and considered its validity,
completeness, and reliability as well as
the relationship of the results of the
studies to human risk. EPA has also
considered available information
concerning the variability of the
sensitivities of major identifiable
subgroups of consumers, including
infants and children. Fluoxastrobin
shows low acute toxicity via the oral,
dermal, and inhalation routes of
exposure; is a moderate eye irritant; and
is neither a dermal irritant nor a
sensitizer. Following repeated
administration, fluoxastrobin has mild
or low toxicity in all tested species other
than the dog which displayed adverse
liver toxicity at considerably lower
doses than those noted for other testing
species. The most common finding
across all testing species is decreased
body weight. In the available toxicity
studies on fluoxastrobin, there is no
estrogen, androgen, and/or thyroid
mediated toxicity. Fluoxastrobin does
not produce developmental toxicity in
rats or rabbits. In the rat and rabbit
developmental toxicity studies and the
two-generation reproduction rat study,
there is no increased susceptibility to
prenatal or postnatal exposure to
fluoxastrobin and no effects on
reproduction. Fluoxastrobin is not
neurotoxic following acute or repeated
dosing in the rat. Fluoxastrobin is not
genotoxic, and it is also not
carcinogenic in rats or mice. Specific
information on the studies received and
the nature of the adverse effects caused
by fluoxastrobin as well as the noobserved-adverse-effect-level (NOAEL)
and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies
are discussed in the final rule published
in the Federal Register of September 16,
2005 (70 FR 54640) (FRL–7719–9).
B. Toxicological Endpoints
For hazards that have a threshold
below which there is no appreciable
risk, a toxicological point of departure
(POD) is identified as the basis for
derivation of reference values for risk
assessment. The POD may be defined as
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the highest dose at which no adverse
effects are observed (the NOAEL) in the
toxicology study identified as
appropriate for use in risk assessment.
However, if a NOAEL cannot be
determined, the lowest dose at which
adverse effects of concern are identified
(the LOAEL) or a Benchmark Dose
(BMD) approach is sometimes used for
risk assessment. Uncertainty/safety
factors (UFs) are used in conjunction
with the POD to take into account
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. Safety is assessed for acute
and chronic dietary risks by comparing
aggregate food and water exposure to
the pesticide to the acute population
adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The
aPAD and cPAD are calculated by
dividing the POD by all applicable UFs.
Aggregate short-, intermediate-, and
chronic-term risks are evaluated by
comparing food, water, and residential
exposure to the POD to ensure that the
margin of exposure (MOE) called for by
the product of all applicable UFs is not
exceeded. This latter value is referred to
as the Level of Concern (LOC).
For non-threshold risks, the Agency
assumes that any amount of exposure
will lead to some degree of risk. Thus,
the Agency estimates risk in terms of the
probability of an occurrence of the
adverse effect greater than that expected
in a lifetime. For more information on
the general principles EPA uses in risk
characterization and a complete
description of the risk assessment
process, see https://www.epa.gov/
pesticides/factsheets/riskassess.htm.
A summary of the toxicological
endpoints for fluoxastrobin used for
human risk assessment can be found at
https://www.regulations.gov in the
document ‘‘Fluoxastrobin. Human
Health Risk Assessment for Proposed
Uses on Field Corn, Soybean, and the
Low-Growing Berry Subgroup 13-07G,’’
at page 20 in docket ID number EPA–
HQ–OPP–2008–0704.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to fluoxastrobin, EPA
considered exposure under the
petitioned-for tolerances as well as all
existing fluoxastrobin tolerances in 40
CFR 180.609. EPA assessed dietary
exposures from fluoxastrobin in food as
follows:
i. Acute exposure. Quantitative acute
dietary exposure and risk assessments
are performed for a food-use pesticide if
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a toxicological study has indicated the
possibility of an effect of concern
occurring as a result of a 1–day or single
exposure. No such effects were
identified in the toxicological studies
for fluoxastrobin; therefore, a
quantitative acute dietary exposure
assessment was not performed.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the food consumption data
from the United States Department of
Agriculture 1994–1996 and 1998 CSFII.
As to residue levels in food, EPA
performed an unrefined dietary (food
and drinking water) exposure
assessment. The assumptions of this
dietary assessment included tolerance
level residues and 100% crop treated.
Experimentally derived processing
factors were applied for tomato puree,
potato chips, dry potato granules/flakes,
and potato flour. For all other processed
commodities, DEEM version 7.81
default processing factors were
assumed.
iii. Cancer. The Agency has
concluded that fluoxastrobin is not
likely to be carcinogenic to humans.
Therefore cancer risk is not of concern
for this chemical.
iv. Anticipated residue and percent
crop treated (PCT) information. EPA did
not use anticipated residue or less than
100% crop treated information in the
dietary assessment for fluoxastrobin.
Tolerance level residues and 100% CT
were assumed for all food commodities.
2. Dietary exposure from drinking
water. The Agency used screening level
water exposure models in the dietary
exposure analysis and risk assessment
for fluoxastrobin in drinking water.
These simulation models take into
account data on the physical, chemical,
and fate/transport characteristics of
fluoxastrobin. Further information
regarding EPA drinking water models
used in pesticide exposure assessment
can be found at https://www.epa.gov/
oppefed1/models/water/index.htm.
Based on the FQPA Index Reservoir
Screening Tool (FIRST) and Screening
Concentration in Ground Water (SCIGROW) models, the estimated drinking
water concentrations (EDWCs) of
fluoxastrobin for chronic exposures for
non-cancer assessments are estimated to
be 28 parts per billion (ppb) for surface
water and less than 1 ppb for ground
water. The modeled estimate of surface
drinking water concentration was
directly entered into the dietary
exposure model. For chronic dietary
risk assessment, a water concentration
value of 28 ppb was used to assess the
contribution of drinking water.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
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this document to refer to nonoccupational, non-dietary exposure
(e.g., for lawn and garden pest control,
indoor pest control, termite control, and
flea and tick control on pets).
Fluoxastrobin is currently registered
for the following uses that could result
in postapplication residential
exposures: Turf, including lawns and
golf courses. No residential handler
exposure uses have been registered
because all applications to residential
turf must be made by a certified pest
control operator. EPA assessed
residential exposure using the following
assumptions: Maximum application
rates, no dissipation of residues after the
day of application, and no dissipation of
residues because of periodic growth and
recutting of the grass. The Agency
believes that the calculated risks
represent screening level estimates.
Principal potential routes of exposure
include dermal and incidental oral
ingestion. The Agency has assumed that
most residential use will result in shortterm exposures but that intermediateterm exposures are also possible. It
should be noted that the new
fluoxastrobin uses assessed for this final
rule do not include any residential uses.
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.’’
EPA has not found fluoxastrobin to
share a common mechanism of toxicity
with any other substances, and
fluoxastrobin does not appear to
produce a toxic metabolite produced by
other substances. For the purposes of
this tolerance action, therefore, EPA has
assumed that fluoxastrobin does not
have 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 EPA’s website at https://
www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and
Children
1. In general. Section 408(b)(2)(C) of
FFDCA provides that EPA shall apply
an additional tenfold (10X) margin of
safety for infants and children in the
case of threshold effects to account for
prenatal and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
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based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
FQPA SF. In applying this provision,
EPA either retains the default value of
10X, or uses a different additional safety
factor when reliable data available to
EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity.
The toxicity database for fluoxastrobin,
including acceptable developmental
toxicity studies in rats and rabbits, as
well as a two-generation reproduction
toxicity study, provides no indication of
prenatal and/or postnatal sensitivity.
3. Conclusion. EPA has determined
that reliable data show the safety of
infants and children would be
adequately protected if the FQPA SF
were reduced to 1X. That decision is
based on the following findings:
i. The toxicity database for
fluoxastrobin is considered adequate to
support endpoint selection for risk
assessment and FQPA evaluation. The
submitted studies are of good quality
and provide sufficient information to
determine whether fluoxastrobin poses
a human health hazard. The only data
deficiency that exists is the requirement
for additional information concerning
the mouse subchronic immunotoxicity
study, for potential upgrade of the
study. To address the immunotoxicity
data requirement as presented in 40 CFR
part 158 the Agency has examined the
entire toxicity database for fluoxastrobin
and drawn the following conclusion:
There is no evidence of biologically
relevant effects on the immune system
that are related to fluoxastrobin and the
overall weight of the evidence indicates
that this chemical does not directly
target the immune system.
ii. There is no indication that
fluoxastrobin is a neurotoxic chemical
and there is no need for a
developmental neurotoxicity study or
additional UFs to account for
neurotoxicity.
iii. There is no indication of increased
quantitative or qualitative susceptibility
in rats or rabbits following in utero and/
or postnatal exposure to fluoxastrobin.
iv. There are no residual uncertainties
identified in the exposure database. The
chronic dietary food exposure
assessment utilizes proposed tolerancelevel residues and 100% crop treated
information for all commodities. Use of
these screening-level assessment values
helps ensure that chronic exposures and
risks will not be underestimated. EPA
additionally made conservative
(protective) assumptions in the ground
and surface water modeling used to
assess exposure to fluoxastrobin in
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drinking water. EPA used similarly
conservative assumptions to assess
residential post-application exposure of
children as well as incidental oral
exposure of toddlers to fluoxastrobin.
These assessments will not
underestimate the exposure and risks
posed by fluoxastrobin.
E. Aggregate Risks and Determination of
Safety
EPA determines whether acute and
chronic pesticide exposures are safe by
comparing aggregate exposure estimates
to the aPAD and cPAD. The aPAD and
cPAD represent the highest safe
exposures, taking into account all
appropriate SFs. EPA calculates the
aPAD and cPAD by dividing the POD by
all applicable UFs. For linear cancer
risks, EPA calculates the probability of
additional cancer cases given the
estimated aggregate exposure. Short-,
intermediate-, and chronic-term risks
are evaluated by comparing the
estimated aggregate food, water, and
residential exposure to the POD to
ensure that the MOE called for by the
product of all applicable UFs is not
exceeded.
1. Acute risk. An acute aggregate risk
assessment takes into account exposure
estimates from acute dietary
consumption of food and drinking
water. No adverse effect resulting from
a single-oral exposure was identified
and no acute dietary endpoint was
selected. Therefore, fluoxastrobin is not
expected to pose an acute risk.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that chronic exposure to fluoxastrobin
from food and water will utilize 38% of
the cPAD for children 1 to 2 years old,
the population group receiving the
greatest exposure. Based on the
explanation in Unit III.C.3., regarding
residential use patterns, chronic
residential exposure to residues of
fluoxastrobin is not expected.
3. Short- and intermediate-term risk.
Fluoxastrobin is currently registered for
uses that could result in both short- and
intermediate-term residential exposure
and the Agency has determined that it
is appropriate to aggregate chronic
exposure through food and water with
short- and intermediate-term residential
exposures to fluoxastrobin. Short- and
intermediate-term aggregate exposure
assessments take into account short- and
intermediate-term residential exposure,
respectively, plus chronic exposure to
food and water (considered to be a
background exposure level). Because all
short- and intermediate-term
quantitative hazard estimates (via the
dermal and incidental oral routes) for
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fluoxastrobin are based on the same
endpoint, a screening-level,
conservative aggregate risk assessment
was conducted that combined the shortterm incidental oral and intermediateterm exposure estimates (i.e., the
highest exposure estimates). The
Agency believes that most residential
exposure will be short-term, based on
the use pattern.
Using the exposure assumptions
described in this unit for short-term
exposures, EPA has concluded that the
combined short- and intermediate-term
food, water, and residential exposures
aggregated result in aggregate MOEs of
750 for adult males, 840 for adult
females, and 160 for children 1 to 2
years old. For adult males and adult
females, residential exposure is via the
oral (background) and dermal (primary)
routes. For children 1 to 2 years old,
residential exposure is via the oral
(background) and incidental oral and
dermal (primary) routes.
4. Aggregate cancer risk for the U.S.
population. The Agency has concluded
that fluoxastrobin is not likely to be
carcinogenic to humans. Therefore
cancer risk is not of concern for this
chemical.
5. Determination of safety. Based on
these risk assessments, EPA concludes
that there is a reasonable certainty that
no harm will result to the general
population, or to infants and children,
from aggregate exposure to fluoxastrobin
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(liquid chromatography/mass
spectrometry/mass spectrometry
method) is available to enforce the
tolerance expression. Method No. 00604
is available for plant commodities and
Method No. 00691, Modification 001, is
available for animal commodities. The
methods may be requested from: Chief,
Analytical Chemistry Branch,
Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755–5350;
telephone number: (410) 305–2905; email address: residuemethods@epa.gov.
B. International Residue Limits
There are currently no established
Codex, Canadian, or Mexican Maximum
Residue Levels (MRLs) for fluoxastrobin
for the low-growing berry subgroup 1307G, soybean, or field corn
commodities.
C. Revisions to Petitioned-For
Tolerances
EPA converted ‘‘corn, field, fodder/
stover’’ to ‘‘corn, field, stover’’ to
PO 00000
Frm 00062
Fmt 4700
Sfmt 4700
conform to the terminology in the
current pesticide commodity
vocabulary. The Agency also replaced
‘‘corn, field, aspirated grain fractions’’
and ‘‘soybean, aspirated grain fractions’’
with ‘‘aspirated grain fractions’’ to
conform to the terminology in the
current pesticide commodity
vocabulary. The proposed tolerances of
0.50 ppm in or on corn, field, aspirated
grain fractions and 0.40 ppm in or on
soybean, aspirated grain fractions were
changed to a tolerance of 20 ppm in or
on aspirated grain fractions based on
current guidance, which recommends
that the established tolerance be based
on the aspirated grain fraction that has
the highest residues. In this case it is
soybean. The soybean highest available
field trial (HAFT) residue of 0.031 ppm
multiplied by the expected processing
factor for aspirated grain fractions of
611x produces calculated expected
residues in aspirated grain fractions of
18.9 ppm. The fluoxastrobin tolerance
in/on aspirated grain fractions was
therefore set at 20 ppm. The proposed
tolerance of 0.40 ppm in/on soybean
hulls was reduced to 0.20 ppm because
the HAFT residue for soybean of 0.031
ppm is expected to concentrate 4x in
soybean hulls. This produces a
calculated residue of 0.124 ppm and a
decision that a tolerance of 0.20 ppm is
appropriate. In addition, the
establishment of tolerances on field corn
commodities requires that the tolerance
for indirect and inadvertent residues for
fluoxastrobin and its Z isomer in/on
grain, cereal, forage, fodder, and straw,
group 16, be modified to apply to grain,
cereal, forage, fodder, and straw, group
16, except corn instead. The tolerance
expressions in 40 CFR 180.609 are also
being modified to conform to new
Agency guidance on the language
tolerance expressions should conform
to, but this change does not have any
other effect on the existing fluoxastrobin
tolerances.
V. Conclusion
Therefore, tolerances are established
for the combined residues of
fluoxastrobin, (1E)-[2-[[6-(2chlorophenoxy)-5-fluoro-4-pyrimidinyl
]oxy]phenyl](5,6-dihydro-1,4,2dioxazin-3-yl)methanone Omethyloxime and its Z isomer, (1Z)-[2[[6-(2-chlorophenoxy)-5-fluoro-4pyrimidinyl]oxy]phenyl](5,6-dihydro1,4,2-dioxazin-3-yl)methanone Omethyloxime, in or on aspirated grain
fractions at 20 ppm; berry, low growing,
subgroup 13-07G at 1.9 ppm; corn, field,
forage at 3.0 ppm; corn, field, grain at
0.02 ppm; corn, field, stover at 4.5 ppm;
soybean, forage at 9.0 ppm; soybean,
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hay at 1.2 ppm; soybean, hulls at 0.20
ppm; and soybean, seed at 0.05 ppm.
VI. Statutory and Executive Order
Reviews
This final rule establishes tolerances
under section 408(d) of FFDCA in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled Regulatory
Planning and Review (58 FR 51735,
October 4, 1993). Because this final rule
has been exempted from review under
Executive Order 12866, this final rule is
not subject to Executive Order 13211,
entitled Actions Concerning Regulations
That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001) or Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
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., 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).
Since tolerances and exemptions that
are established on the basis of a petition
under section 408(d) 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.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply
to this final rule. In addition, this final
rule does not impose any enforceable
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14:11 Dec 17, 2009
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duty or contain any unfunded mandate
as described under Title II of the
Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104–4).
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).
VII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report 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: December 8, 2009.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
■
O-methyloxime, calculated as the
stoichiometric equivalent of
fluoxastrobin.
Commodity
Aspirated grain fractions .......
Berry, low growing, subgroup
13-07G ..............................
Corn, field, forage .................
Corn, field, grain ...................
Corn, field, stover .................
Leaf petioles subgroup 4B ...
Peanut ..................................
Peanut, hay ..........................
Peanut, refined oil ................
Soybean, forage ...................
Soybean, hay ........................
Soybean, hulls ......................
Soybean, seed ......................
Tomato, paste .......................
Vegetable, fruiting, group 8 ..
Vegetable, tuberous and
corm, subgroup 1C ...........
Commodity
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.609 is revised to read
as follows:
■
§ 180.609 Fluoxastrobin; tolerances for
residues.
(a) General. (1) Tolerances are
established for residues of fluoxastrobin,
including its metabolites and
degradates, in or on the commodities in
the table below. Compliance with the
tolerance levels specified below is to be
determined by measuring only
fluoxastrobin, (1E)-[2-[[6-(2-chloro
phenoxy)-5-fluoro-4-pyrimidinyl]
oxy]phenyl](5,6-dihydro-1,4,2-dioxazin3-yl)methanone O-methyloxime and its
Z isomer, (1Z)-[2-[[6-(2-chlorophenoxy)5-fluoro-4-pyrimidinyl]oxy]phenyl](5,6dihydro-1,4,2-dioxazin-3-yl)methanone
PO 00000
Frm 00063
Fmt 4700
Sfmt 4700
Parts per million
20
1.9
3.0
0.02
4.5
4.0
0.010
20.0
0.030
9.0
1.2
0.20
0.05
1.5
1.0
0.010
(2) Tolerances are established for
residues of fluoxastrobin, including its
metabolites and degradates, in or on the
commodities in the table below.
Compliance with the tolerance levels
specified below is to be determined by
measuring only fluoxastrobin, (1E)-[2[[6-(2-chlorophenoxy)-5-fluoro-4pyrimidinyl]oxy]phenyl](5,6-dihydro1,4,2-dioxazin-3-yl)methanone Omethyloxime, its Z isomer, (1Z)-[2-[[6-(2
-chlorophenoxy)-5-fluoro-4pyrimidinyl]oxy]phenyl](5,6-dihydro1,4,2-dioxazin-3-yl)methanone Omethyloxime, and its phenoxy-hydroxy
pyrimidine, 6-(2-chlorophenoxy)-5fluoro-4-pyrimidinol, calculated as the
stoichiometric equivalent of
fluoxastrobin.
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
67113
Cattle, fat ..............................
Cattle, meat ..........................
Cattle, meat byproducts .......
Goat, fat ................................
Goat, meat ............................
Goat, meat byproducts .........
Horse, fat ..............................
Horse, meat ..........................
Horse, meat, byproducts ......
Milk .......................................
Milk, fat .................................
Sheep, fat .............................
Sheep, meat .........................
Sheep, meat byproducts ......
Parts per million
0.10
0.05
0.10
0.10
0.05
0.10
0.10
0.05
0.10
0.02
0.50
0.10
0.05
0.10
(b) Section 18 emergency exemptions.
[Reserved]
(c) Tolerances with regional
registrations. [Reserved]
(d) Indirect or inadvertent residues.
Tolerances are established for the
indirect or inadvertent residues of
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fluoxastrobin, including its metabolites
and degradates, in or on the
commodities in the table below, when
present therein as a result of the
application of fluoxastrobin to the
growing crops listed in paragraph (a)(1)
of this section. Compliance with the
tolerance levels specified below is to be
determined by measuring only
fluoxastrobin, (1E)-[2-[[6-(2chlorophenoxy)-5-fluoro-4-pyrimidinyl]
oxy]phenyl](5,6-dihydro-1,4,2-dioxazin3-yl)methanone O-methyloxime and its
Z isomer, (1Z)-[2-[[6-(2-chlorophenoxy)5-fluoro-4-pyrimidinyl]oxy]phenyl](5,6dihydro-1,4,2-dioxazin-3-yl)methanone
O-methyloxime, calculated as the
stoichiometric equivalent of
fluoxastrobin.
Commodity
Parts per million
Alfalfa, forage .......................
Alfalfa, hay ............................
Cotton, gin byproducts .........
Grain, cereal, forage, fodder,
and straw, group 16, except corn ...........................
Grass, forage ........................
Grass, hay ............................
Vegetable, foliage of legume,
group 7 ..............................
0.050
0.10
0.020
0.10
0.10
0.50
0.050
[FR Doc. E9–30039 Filed 12–17–09; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2008–0276; FRL–8800–8]
Prosulfuron; Pesticide Tolerances
erowe on DSK5CLS3C1PROD with RULES
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes
tolerances for residues of prosulfuron
and its metabolites and degradates in or
on cereal grain commodities. Syngenta
Crop Protection, Inc. requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective
December 18, 2009. Objections and
requests for hearings must be received
on or before February 16, 2010, and
must be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2008–0276. All documents in the
docket are listed in the docket index
VerDate Nov<24>2008
14:11 Dec 17, 2009
Jkt 220001
available at https://www.regulations.gov.
Although listed in the index, some
information is not publicly available,
e.g., 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 in the electronic docket at
https://www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S–
4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The
Docket Facility is open from 8:30 a.m.
to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket
Facility telephone number is (703) 305–
5805.
FOR FURTHER INFORMATION CONTACT:
Susan Stanton, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–5218; e-mail address:
stanton.susan@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 those engaged in the
following activities:
• 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 to provide a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Get Electronic Access to
Other Related Information?
You may access a frequently updated
electronic version of EPA’s tolerance
PO 00000
Frm 00064
Fmt 4700
Sfmt 4700
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
cite at https://www.gpoaccess.gov/ecfr.
To access the OPPTS harmonized test
guidelines referenced in this document
electronically, please go to https://
www.epa.gov/oppts and select ‘‘Test
Methods & Guidelines’’ on the left-side
navigation menu.
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of FFDCA, 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2008–0276 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
as required by 40 CFR part 178 on or
before February 16, 2010.
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing that does not
contain any CBI for inclusion in the
public docket that is described in
ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit this copy,
identified by docket ID number EPA–
HQ–OPP–2008–0276, by one of the
following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries
are only accepted during the Docket
Facility’s normal hours of operation
(8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays).
Special arrangements should be made
for deliveries of boxed information. The
Docket Facility telephone number is
(703) 305–5805.
II. Petition for Tolerance
In the Federal Register of August 13,
2008 (73 FR 47186) (FRL–8375–8), EPA
issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
E:\FR\FM\18DER1.SGM
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]]>Agencies
[Federal Register Volume 74, Number 242 (Friday, December 18, 2009)]
[Rules and Regulations]
[Pages 67108-67114]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-30039]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2008-0704; FRL-8803-4]
Fluoxastrobin; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
[[Page 67109]]
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for combined residues
of fluoxastrobin and its Z isomer in or on berry, low growing, subgroup
13-07G; corn, field, grain; corn, field, forage; corn, field, stover;
soybean, forage; soybean, hay; soybean, hulls; soybean, seed; and
aspirated grain fractions. Arysta LifeScience North America, LLC
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA).
DATES: This regulation is effective December 18, 2009. Objections and
requests for hearings must be received on or before February 16, 2010,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2008-0704. All documents in the
docket are listed in the docket index available at https://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., 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 in the electronic
docket at https://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.
FOR FURTHER INFORMATION CONTACT: John Bazuin, Registration Division,
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703) 305-7381; e-mail address: bazuin.john@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 those
engaged in the following activities:
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 to
provide 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?
In addition to accessing electronically available documents at
https://www.regulations.gov, you may access this Federal Register
document electronically through the EPA Internet under the ``Federal
Register'' listings at https://www.epa.gov/fedrgstr. You may also access
a frequently updated electronic version of EPA's tolerance regulations
at 40 CFR part 180 through the Government Printing Office's e-CFR cite
at https://www.gpoaccess.gov/ecfr. To access the OPPTS harmonized test
guidelines referenced in this document electronically, please go to
https://www.epa.gov/oppts and select ``Test Methods & Guidelines'' on
the left-side navigation menu.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2008-0704 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 as required by 40 CFR part 178
on or before February 16, 2010.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2008-0704, by one of the following methods:
Federal eRulemaking Portal https://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
II. Petition for Tolerance
In the Federal Register of December 3, 2008 (73 FR 73640) (FRL-
8390-4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
8F7437) by Arysta LifeScience North America, LLC, 15401 Weston Parkway,
Suite 150, Cary, NC 27513. The petition requested that 40 CFR 180.609
be amended by establishing tolerances for combined residues of the
fungicide fluoxastrobin, (1E)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-
pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-
methyloxime and its Z isomer, (1Z)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-
pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-
methyloxime, in or on corn, field, grain at 0.02 parts per million
(ppm); corn, field, aspirated grain fractions at 0.50 ppm; corn, field,
forage at 3.0 ppm; corn, field, fodder/stover at 4.5 ppm; soybean, seed
at 0.05 ppm; soybean, aspirated grain fractions at 0.40 ppm; soybean,
forage at 9.0 ppm; soybean, hay at 1.2 ppm; and soybean, hulls at 0.40
ppm.
Also in the Federal Register of December 3, 2008 (73 FR 73644)
(FRL-8386-9), EPA issued a notice pursuant to section 408(d)(3) of
FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a another
pesticide petition (PP 8F7406) by Arysta LifeScience North America,
LLC. The petition requested that 40 CFR 180.609 be amended by
establishing
[[Page 67110]]
tolerances for the combined residues of the fungicide fluoxastrobin,
(1E)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-pyrimidinyl]oxy]phenyl](5,6-
dihydro-1,4,2-dioxazin-3-yl)methanone O-methyloxime and its Z isomer,
(1Z)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-pyrimidinyl]oxy]phenyl](5,6-
dihydro-1,4,2-dioxazin-3-yl)methanone O-methyloxime , in or on low
growing berries (crop subgroup 13-07G) at 1.9 ppm. Each notice
referenced a summary of the appropriate petition which had been
prepared by Arysta LifeScience North America, LLC, the registrant, and
is available to the public in the docket, https://www.regulations.gov.
There were no comments received in response to the notice of filing.
Based upon review of the data supporting the petition, EPA has
corrected the commodity and subgroup names, and replaced ``corn, field,
aspirated grain fractions'' and ``soybeans, aspirated grain fractions''
with ``aspirated grain fractions.'' EPA has also substantially
increased the tolerance for aspirated grain fractions and decreased the
tolerance for soybean, hulls. The reasons for these changes are
explained in Unit IV.C.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal upper 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....''
Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in 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 and to
make a determination on aggregate exposure for the petitioned-for
tolerances for the combined residues of fluoxastrobin and its Z isomer
in or on aspirated grain fractions at 20 ppm; berry, low growing,
subgroup 13-07G at 1.9 ppm; corn, field, forage at 3.0 ppm; corn, field
grain at 0.02 ppm; corn, field, stover at 4.5 ppm; soybean, forage at
9.0 ppm; soybean, hay at 1.2 ppm; soybean, hulls at 0.20 ppm; soybean,
seed at 0.05 ppm. EPA's assessment of exposures and risks associated
with establishing tolerances follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Fluoxastrobin shows low acute toxicity via the oral, dermal,
and inhalation routes of exposure; is a moderate eye irritant; and is
neither a dermal irritant nor a sensitizer. Following repeated
administration, fluoxastrobin has mild or low toxicity in all tested
species other than the dog which displayed adverse liver toxicity at
considerably lower doses than those noted for other testing species.
The most common finding across all testing species is decreased body
weight. In the available toxicity studies on fluoxastrobin, there is no
estrogen, androgen, and/or thyroid mediated toxicity. Fluoxastrobin
does not produce developmental toxicity in rats or rabbits. In the rat
and rabbit developmental toxicity studies and the two-generation
reproduction rat study, there is no increased susceptibility to
prenatal or postnatal exposure to fluoxastrobin and no effects on
reproduction. Fluoxastrobin is not neurotoxic following acute or
repeated dosing in the rat. Fluoxastrobin is not genotoxic, and it is
also not carcinogenic in rats or mice. Specific information on the
studies received and the nature of the adverse effects caused by
fluoxastrobin as well as the no-observed-adverse-effect-level (NOAEL)
and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity
studies are discussed in the final rule published in the Federal
Register of September 16, 2005 (70 FR 54640) (FRL-7719-9).
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse effects are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which adverse effects of
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the POD to take into account 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. Safety is assessed for acute and chronic
dietary risks by comparing aggregate food and water exposure to the
pesticide to the acute population adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The aPAD and cPAD are calculated by
dividing the POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and
residential exposure to the POD to ensure that the margin of exposure
(MOE) called for by the product of all applicable UFs is not exceeded.
This latter value is referred to as the Level of Concern (LOC).
For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk. Thus, the Agency estimates
risk in terms of the probability of an occurrence of the adverse effect
greater than that expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see https://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for fluoxastrobin used for
human risk assessment can be found at https://www.regulations.gov in the
document ``Fluoxastrobin. Human Health Risk Assessment for Proposed
Uses on Field Corn, Soybean, and the Low-Growing Berry Subgroup 13-
07G,'' at page 20 in docket ID number EPA-HQ-OPP-2008-0704.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to fluoxastrobin, EPA considered exposure under the
petitioned-for tolerances as well as all existing fluoxastrobin
tolerances in 40 CFR 180.609. EPA assessed dietary exposures from
fluoxastrobin in food as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide if
[[Page 67111]]
a toxicological study has indicated the possibility of an effect of
concern occurring as a result of a 1-day or single exposure. No such
effects were identified in the toxicological studies for fluoxastrobin;
therefore, a quantitative acute dietary exposure assessment was not
performed.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the United States
Department of Agriculture 1994-1996 and 1998 CSFII. As to residue
levels in food, EPA performed an unrefined dietary (food and drinking
water) exposure assessment. The assumptions of this dietary assessment
included tolerance level residues and 100% crop treated. Experimentally
derived processing factors were applied for tomato puree, potato chips,
dry potato granules/flakes, and potato flour. For all other processed
commodities, DEEM version 7.81 default processing factors were assumed.
iii. Cancer. The Agency has concluded that fluoxastrobin is not
likely to be carcinogenic to humans. Therefore cancer risk is not of
concern for this chemical.
iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue or less than 100% crop treated
information in the dietary assessment for fluoxastrobin. Tolerance
level residues and 100% CT were assumed for all food commodities.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for fluoxastrobin in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of fluoxastrobin. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at https://www.epa.gov/oppefed1/models/water/index.htm.
Based on the FQPA Index Reservoir Screening Tool (FIRST) and
Screening Concentration in Ground Water (SCI-GROW) models, the
estimated drinking water concentrations (EDWCs) of fluoxastrobin for
chronic exposures for non-cancer assessments are estimated to be 28
parts per billion (ppb) for surface water and less than 1 ppb for
ground water. The modeled estimate of surface drinking water
concentration was directly entered into the dietary exposure model. For
chronic dietary risk assessment, a water concentration value of 28 ppb
was used to assess the contribution of drinking 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,
termite control, and flea and tick control on pets).
Fluoxastrobin is currently registered for the following uses that
could result in postapplication residential exposures: Turf, including
lawns and golf courses. No residential handler exposure uses have been
registered because all applications to residential turf must be made by
a certified pest control operator. EPA assessed residential exposure
using the following assumptions: Maximum application rates, no
dissipation of residues after the day of application, and no
dissipation of residues because of periodic growth and recutting of the
grass. The Agency believes that the calculated risks represent
screening level estimates. Principal potential routes of exposure
include dermal and incidental oral ingestion. The Agency has assumed
that most residential use will result in short-term exposures but that
intermediate-term exposures are also possible. It should be noted that
the new fluoxastrobin uses assessed for this final rule do not include
any residential uses.
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.''
EPA has not found fluoxastrobin to share a common mechanism of
toxicity with any other substances, and fluoxastrobin does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
fluoxastrobin does not have 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 EPA's website at https://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA SF. In
applying this provision, EPA either retains the default value of 10X,
or uses a different additional safety factor when reliable data
available to EPA support the choice of a different factor.
2. Prenatal and postnatal sensitivity. The toxicity database for
fluoxastrobin, including acceptable developmental toxicity studies in
rats and rabbits, as well as a two-generation reproduction toxicity
study, provides no indication of prenatal and/or postnatal sensitivity.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
i. The toxicity database for fluoxastrobin is considered adequate
to support endpoint selection for risk assessment and FQPA evaluation.
The submitted studies are of good quality and provide sufficient
information to determine whether fluoxastrobin poses a human health
hazard. The only data deficiency that exists is the requirement for
additional information concerning the mouse subchronic immunotoxicity
study, for potential upgrade of the study. To address the
immunotoxicity data requirement as presented in 40 CFR part 158 the
Agency has examined the entire toxicity database for fluoxastrobin and
drawn the following conclusion: There is no evidence of biologically
relevant effects on the immune system that are related to fluoxastrobin
and the overall weight of the evidence indicates that this chemical
does not directly target the immune system.
ii. There is no indication that fluoxastrobin is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
iii. There is no indication of increased quantitative or
qualitative susceptibility in rats or rabbits following in utero and/or
postnatal exposure to fluoxastrobin.
iv. There are no residual uncertainties identified in the exposure
database. The chronic dietary food exposure assessment utilizes
proposed tolerance-level residues and 100% crop treated information for
all commodities. Use of these screening-level assessment values helps
ensure that chronic exposures and risks will not be underestimated. EPA
additionally made conservative (protective) assumptions in the ground
and surface water modeling used to assess exposure to fluoxastrobin in
[[Page 67112]]
drinking water. EPA used similarly conservative assumptions to assess
residential post-application exposure of children as well as incidental
oral exposure of toddlers to fluoxastrobin. These assessments will not
underestimate the exposure and risks posed by fluoxastrobin.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the POD to ensure that the MOE called for
by the product of all applicable UFs is not exceeded.
1. Acute risk. An acute aggregate risk assessment takes into
account exposure estimates from acute dietary consumption of food and
drinking water. No adverse effect resulting from a single-oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
fluoxastrobin is not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
fluoxastrobin from food and water will utilize 38% of the cPAD for
children 1 to 2 years old, the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
fluoxastrobin is not expected.
3. Short- and intermediate-term risk. Fluoxastrobin is currently
registered for uses that could result in both short- and intermediate-
term residential exposure and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short- and intermediate-term residential exposures to fluoxastrobin.
Short- and intermediate-term aggregate exposure assessments take into
account short- and intermediate-term residential exposure,
respectively, plus chronic exposure to food and water (considered to be
a background exposure level). Because all short- and intermediate-term
quantitative hazard estimates (via the dermal and incidental oral
routes) for fluoxastrobin are based on the same endpoint, a screening-
level, conservative aggregate risk assessment was conducted that
combined the short-term incidental oral and intermediate-term exposure
estimates (i.e., the highest exposure estimates). The Agency believes
that most residential exposure will be short-term, based on the use
pattern.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that the combined short- and
intermediate-term food, water, and residential exposures aggregated
result in aggregate MOEs of 750 for adult males, 840 for adult females,
and 160 for children 1 to 2 years old. For adult males and adult
females, residential exposure is via the oral (background) and dermal
(primary) routes. For children 1 to 2 years old, residential exposure
is via the oral (background) and incidental oral and dermal (primary)
routes.
4. Aggregate cancer risk for the U.S. population. The Agency has
concluded that fluoxastrobin is not likely to be carcinogenic to
humans. Therefore cancer risk is not of concern for this chemical.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children, from aggregate
exposure to fluoxastrobin residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (liquid chromatography/mass
spectrometry/mass spectrometry method) is available to enforce the
tolerance expression. Method No. 00604 is available for plant
commodities and Method No. 00691, Modification 001, is available for
animal commodities. The methods may be requested from: Chief,
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail
address: residuemethods@epa.gov.
B. International Residue Limits
There are currently no established Codex, Canadian, or Mexican
Maximum Residue Levels (MRLs) for fluoxastrobin for the low-growing
berry subgroup 13-07G, soybean, or field corn commodities.
C. Revisions to Petitioned-For Tolerances
EPA converted ``corn, field, fodder/stover'' to ``corn, field,
stover'' to conform to the terminology in the current pesticide
commodity vocabulary. The Agency also replaced ``corn, field, aspirated
grain fractions'' and ``soybean, aspirated grain fractions'' with
``aspirated grain fractions'' to conform to the terminology in the
current pesticide commodity vocabulary. The proposed tolerances of 0.50
ppm in or on corn, field, aspirated grain fractions and 0.40 ppm in or
on soybean, aspirated grain fractions were changed to a tolerance of 20
ppm in or on aspirated grain fractions based on current guidance, which
recommends that the established tolerance be based on the aspirated
grain fraction that has the highest residues. In this case it is
soybean. The soybean highest available field trial (HAFT) residue of
0.031 ppm multiplied by the expected processing factor for aspirated
grain fractions of 611x produces calculated expected residues in
aspirated grain fractions of 18.9 ppm. The fluoxastrobin tolerance in/
on aspirated grain fractions was therefore set at 20 ppm. The proposed
tolerance of 0.40 ppm in/on soybean hulls was reduced to 0.20 ppm
because the HAFT residue for soybean of 0.031 ppm is expected to
concentrate 4x in soybean hulls. This produces a calculated residue of
0.124 ppm and a decision that a tolerance of 0.20 ppm is appropriate.
In addition, the establishment of tolerances on field corn commodities
requires that the tolerance for indirect and inadvertent residues for
fluoxastrobin and its Z isomer in/on grain, cereal, forage, fodder, and
straw, group 16, be modified to apply to grain, cereal, forage, fodder,
and straw, group 16, except corn instead. The tolerance expressions in
40 CFR 180.609 are also being modified to conform to new Agency
guidance on the language tolerance expressions should conform to, but
this change does not have any other effect on the existing
fluoxastrobin tolerances.
V. Conclusion
Therefore, tolerances are established for the combined residues of
fluoxastrobin, (1E)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-
pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-
methyloxime and its Z isomer, (1Z)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-
pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-
methyloxime, in or on aspirated grain fractions at 20 ppm; berry, low
growing, subgroup 13-07G at 1.9 ppm; corn, field, forage at 3.0 ppm;
corn, field, grain at 0.02 ppm; corn, field, stover at 4.5 ppm;
soybean, forage at 9.0 ppm; soybean,
[[Page 67113]]
hay at 1.2 ppm; soybean, hulls at 0.20 ppm; and soybean, seed at 0.05
ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). 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., 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).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) 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.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not 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).
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).
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report 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: December 8, 2009.
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 180.609 is revised to read as follows:
Sec. 180.609 Fluoxastrobin; tolerances for residues.
(a) General. (1) Tolerances are established for residues of
fluoxastrobin, including its metabolites and degradates, in or on the
commodities in the table below. Compliance with the tolerance levels
specified below is to be determined by measuring only fluoxastrobin,
(1E)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-pyrimidinyl]oxy]phenyl](5,6-
dihydro-1,4,2-dioxazin-3-yl)methanone O-methyloxime and its Z isomer,
(1Z)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-pyrimidinyl]oxy]phenyl](5,6-
dihydro-1,4,2-dioxazin-3-yl)methanone O-methyloxime, calculated as the
stoichiometric equivalent of fluoxastrobin.
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Aspirated grain fractions............................... 20
Berry, low growing, subgroup 13-07G..................... 1.9
Corn, field, forage..................................... 3.0
Corn, field, grain...................................... 0.02
Corn, field, stover..................................... 4.5
Leaf petioles subgroup 4B............................... 4.0
Peanut.................................................. 0.010
Peanut, hay............................................. 20.0
Peanut, refined oil..................................... 0.030
Soybean, forage......................................... 9.0
Soybean, hay............................................ 1.2
Soybean, hulls.......................................... 0.20
Soybean, seed........................................... 0.05
Tomato, paste........................................... 1.5
Vegetable, fruiting, group 8............................ 1.0
Vegetable, tuberous and corm, subgroup 1C............... 0.010
------------------------------------------------------------------------
(2) Tolerances are established for residues of fluoxastrobin,
including its metabolites and degradates, in or on the commodities in
the table below. Compliance with the tolerance levels specified below
is to be determined by measuring only fluoxastrobin, (1E)-[2-[[6-(2-
chlorophenoxy)-5-fluoro-4-pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-
dioxazin-3-yl)methanone O-methyloxime, its Z isomer, (1Z)-[2-[[6-(2-
chlorophenoxy)-5-fluoro-4-pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-
dioxazin-3-yl)methanone O-methyloxime, and its phenoxy-
hydroxypyrimidine, 6-(2-chlorophenoxy)-5-fluoro-4-pyrimidinol,
calculated as the stoichiometric equivalent of fluoxastrobin.
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Cattle, fat............................................. 0.10
Cattle, meat............................................ 0.05
Cattle, meat byproducts................................. 0.10
Goat, fat............................................... 0.10
Goat, meat.............................................. 0.05
Goat, meat byproducts................................... 0.10
Horse, fat.............................................. 0.10
Horse, meat............................................. 0.05
Horse, meat, byproducts................................. 0.10
Milk.................................................... 0.02
Milk, fat............................................... 0.50
Sheep, fat.............................................. 0.10
Sheep, meat............................................. 0.05
Sheep, meat byproducts.................................. 0.10
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. Tolerances are established
for the indirect or inadvertent residues of
[[Page 67114]]
fluoxastrobin, including its metabolites and degradates, in or on the
commodities in the table below, when present therein as a result of the
application of fluoxastrobin to the growing crops listed in paragraph
(a)(1) of this section. Compliance with the tolerance levels specified
below is to be determined by measuring only fluoxastrobin, (1E)-[2-[[6-
(2-chlorophenoxy)-5-fluoro-4-pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-
dioxazin-3-yl)methanone O-methyloxime and its Z isomer, (1Z)-[2-[[6-(2-
chlorophenoxy)-5-fluoro-4-pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-
dioxazin-3-yl)methanone O-methyloxime, calculated as the stoichiometric
equivalent of fluoxastrobin.
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Alfalfa, forage......................................... 0.050
Alfalfa, hay............................................ 0.10
Cotton, gin byproducts.................................. 0.020
Grain, cereal, forage, fodder, and straw, group 16, 0.10
except corn............................................
Grass, forage........................................... 0.10
Grass, hay.............................................. 0.50
Vegetable, foliage of legume, group 7................... 0.050
------------------------------------------------------------------------
[FR Doc. E9-30039 Filed 12-17-09; 8:45 am]
BILLING CODE 6560-50-S
