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Fluoxastrobin; Pesticide Tolerances [Federal Register: September
16, 2005 (Volume 70, Number 179)]
[Rules and Regulations]
[Page 54640-54651]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16se05-13]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2003-0129; FRL-7719-9]
Fluoxastrobin; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances
for combined residues
of fluoxastrobin, (1E)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-
pyrimydinyl]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-pyrimydinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone
O-
methyloxime, in or on leaf petioles subgroup 4B; peanut; peanut,
hay;
peanut, refined oil; tomato, paste; vegetable, fruiting, group 8;
and
vegetable, tuberous and corm, subgroup 1C. This
regulation also
establishes tolerances for the indirect or inadvertent combined
residues of fluoxastrobin and its Z isomer, in or on alfalfa,
forage;
alfalfa, hay; cotton, gin byproducts; grain, cereal, forage, fodder
and
straw, group 16; grass, forage; grass, hay; and vegetable, foliage
of
legume, group 7. This regulation additionally
establishes tolerances
for the combined residues of fluoxastrobin, its Z isomer, and its
phenoxy-hydroxypyrimidine metabolite, 6-(2-chlorophenoxy)-5-fluoro-4-
pyrimidinol, expressed as fluoxastrobin, in
or on 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; and sheep, meat byproducts.
Bayer
CropScience requested these tolerances
under the Federal Food, Drug,
and Cosmetic Act (FFDCA), as amended by the Food Quality Protection
Act
of 1996 (FQPA).
DATES: This regulation is effective September 16, 2005. Objections
and
requests for hearings must be received on or before November 15,
2005.
ADDRESSES: To submit a written objection or hearing request follow
the
detailed instructions as provided in Unit VII. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under
. 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.,
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), Rm. 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: Tony Kish, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection
Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-9443; e-mail address: kish.tony@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 111), e.g., agricultural workers;
greenhouse, nursery, and floriculture workers; farmers.
• Animal production (NAICS 112), e.g., cattle ranchers and
farmers, dairy cattle farmers, livestock farmers.
• Food manufacturing (NAICS 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS 32532), e.g., agricultural
workers; commercial applicators; farmers; greenhouse, nursery, and
floriculture workers; residential users.
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 ( http://www.epa.gov/edocket/ ), you
may
access this Federal Register document electronically through the
EPA
Internet under the ``Federal Register'' listings at http://www.epa.gov/
fedrgstr/ . A frequently updated electronic version of 40 CFR part
180
is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/
.
To access the OPPTS Harmonized Guidelines referenced in this
document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm.
II. Background and Statutory Findings
In the Federal Register of April 23, 2003 (68 FR 19991) (FRL-7303-
1), 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
3F6556) by Bayer CropScience, 2 T.W. Alexander Drive, Research Triangle
Park, North Carolina 27709. The petition requests that 40 CFR 180.609
be amended by establishing tolerances for the combined residues
of the
fungicide fluoxastrobin, (1E)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-
pyrimydinyl]-oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone
O-
methyloxime, in or on the raw agricultural commodities (RACs) alfalfa,
forage at 0.05 parts per million (ppm); alfalfa, hay at 1.0 ppm;
cotton, gin byproducts at 0.02 ppm; grain, cereal, forage at 0.10
ppm;
grain, cereal, hay at 0.10 ppm; grain, cereal, stover at 0.10 ppm;
grain, cereal, straw at 0.10 ppm; grass, forage at 0.10 ppm; grass,
hay
at 0.50 ppm; legume, forage at 0.05 ppm; legume, hay at 0.05 ppm;
legume, seed at 0.01 ppm; peanut at 0.01 ppm; peanut, hay at 20
ppm;
peanut, refined oil at 0.10 ppm; tomato, paste at 2.0 ppm; vegetable,
foliage of legume, group 7 at 0.05 ppm; vegetable, fruiting, group
at
1.0 ppm; vegetable, leafy, petioles, except brassica, subgroup at
5.0
ppm; and vegetable, tuberous and corm, subgroup at 0.01 ppm. The
petition also requests that 40 CFR 180.609 be amended by establishing
tolerances for
[[Page 54641]]
the combined residues of fluoxastrobin, (1E)-[2-[[6-(2-chlorophenoxy)-
5-fluoro-4-pyrimydinyl]-oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-
yl)methanone O-methyloxime, and its phenoxy-hydroxypyrimidine
metabolite, 6-(2-chlorophenoxy)-5-fluoro-4-pyrimidinol, in or on
the
RACs cattle, fat at 0.10 ppm; cattle, meat at 0.05 ppm; cattle,
meat
byproducts at 0.20 ppm; milk at 0.01 ppm; and milk, fat at 0.10
ppm.
That notice included a summary of the petition prepared by Bayer
CropScience, the registrant. Several comments
concerning the notice
were received. They are described and discussed in Unit V.
Based on EPA's review, the aforementioned petition was revised by
the petitioner by adjusting some tolerance levels, revising the
tolerance expression, and revising the commodity nomenclature to
reflect the correct commodity definitions. The tolerance expression
was
revised to reflect the fact that fluoxastrobin E-isomer, and not
the
mixture of E- and Z-isomers, is the proposed active ingredient.
The
petition was also revised, based on extensive field rotational crop
data, to add indirect tolerances for the combined residues of
fluoxastrobin and its Z-isomer in/on rotated crops. As revised,
the
petition seeks the establishment of tolerances for combined residues
of
fluoxastrobin, (1E)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-
pyrimydinyl]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-pyrimydinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone
O-
methyloxime, in or on the RACs leaf petioles subgroup 4B at 4.0
ppm;
peanut at 0.010 ppm; peanut, hay at 20.0 ppm; peanut, refined oil
at
0.030 ppm; tomato, paste at 1.5 ppm; vegetable, fruiting, group
8 at
1.0 ppm; and vegetable, tuberous and corm, subgroup 1C at 0.010
ppm,
the establishment of tolerances for indirect or inadvertent residues
for the combined residues of fluoxastrobin and its Z isomer, in
or on
the RACs alfalfa, forage at 0.050 ppm; alfalfa, hay at 0.10 ppm;
cotton, gin byproducts at 0.020 ppm; grain, cereal, forage, fodder,
and
straw, group 16 at 0.10 ppm; grass, forage at 0.10 ppm; grass, hay
at
0.50 ppm; and vegetable, foliage of legume, group 7 at 0.050 ppm;
and
the establishment of tolerances for the combined residues of
fluoxastrobin, its Z isomer, and its phenoxy-hydroxypyrimidine
metabolite, 6-(2-chlorophenoxy)-5-fluoro-4-pyrimidinol, expressed
as
fluoxastrobin, in or on the RACs cattle, fat at 0.10 ppm; cattle,
meat
at 0.05 ppm; cattle, meat byproducts at 0.10 ppm; goat, fat at 0.10
ppm; goat, meat at 0.05 ppm; goat, meat byproducts at 0.10 ppm;
horse,
fat at 0.10 ppm; horse, meat at 0.05 ppm; horse, meat byproducts
0.10
ppm; milk at 0.02 ppm; milk, fat at 0.50 ppm; sheep, fat at 0.10
ppm;
sheep, meat at 0.05 ppm; and sheep, meat byproducts at 0.10 ppm.
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....''
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).
III. Aggregate Risk Assessment and Determination of Safety
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 and
to
make a determination on aggregate exposure, consistent with section
408(b)(2) of FFDCA, for the fluoxastrobin tolerances described in
Unit
II. EPA's assessment of exposures and risks associated with
establishing these 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. The nature of the toxic effects caused by fluoxastrobin
are
discussed in Table 1. of this unit as well as the no observed adverse
effect level (NOAEL) and the lowest observed adverse effect level
(LOAEL) from the toxicity studies reviewed.
Table
1.--Subchronic, Chronic, and Other Toxicity |
Guideline
No. |
Study
Type |
Results |
870.3100
|
90-Day
oral toxicity-rats |
NOAEL was
70.4
milligrams/kilogram/day (mg/
kg/day) for males;
162.9 mg/kg/day for females.
LOAEL was 580.0 mg/kg/day for males based on reduced
body weight gain and food intake, vacuolation in the zona fasciculate
of the adrenal cortex, calculi in the urethra and kidney, and
histological lesions in kidney, urinary bladder, and urethra;
1416.1 mg/kg/day for females based on increased liver
weight (by 20%). |
870.3100 |
90-Day
oral toxicity-mice |
Neither
a NOAEL nor a LOAEL were assigned. There
was a dose related increase in liver weight in both sexes and
in kidney weight in females, in addition to other effects whose
toxicological relevance was considered uncertain. Among
these effects were increased hepatocellular hypertrophy
with cytoplasmic changes in the high-dose males and minimal
to moderate kidney tubular hypertrophy in mid- and high-dose
females. |
870.3150
|
90-Day
oral toxicity-dogs |
NOAEL was
3.0 mg/kg/day (100 ppm) for both males and females.
LOAEL was 24.8/24.2 mg/kg/day (800 ppm) for both males and females
based on dose-related reductions in net
body weight gain and food efficiency in addition to toxicity
findings in the liver in both sexes (cholestasis) and in kidneys
(increased relative weights in females and degeneration of the
proximal tubular epithelium in males). |
870.3200
|
28-Day
dermal toxicity- |
NOAEL was
1,000 mg/kg/day (the limit dose, rats for both systemic and
dermal effects). No LOAEL was identified. |
870.3700 |
Prenatal
development-rats |
Maternal
NOAEL was greater than or equal to 1,000 milligrams per kilogram
bodyweight per day (mg/kg bw/day; limit dose).
No maternal LOAEL was identified.
Developmental NOAEL was greater than or equal to 1,000 mg/kg
bw/day.
No developmental LOAEL was identified. |
870.3800 |
Reproduction
and fertility |
Parental
systemic NOAEL was 70.0 mg/kg/day effects-rats for males and
84.7 mg/kg/day for females.
Parental systemic LOAEL was 665.0
mg/kg/day for males and 825.4 mg/kg/day
for females based on decreased premating body weight
gain of the P-generation males and females and decreased premating
absolute body weight of the F1 males and females.
Reproductive NOAEL was greater than 665.0 mg/kg/day for males
and greater than 825.4 mg/kg/day for females.
No reproductive LOAEL was identified.
Offspring systemic NOAEL was 70.0 mg/kg/day for males and 84.7
mg/kg/day for females.
Offspring systemic LOAEL was 665.0 mg/kg/
day for males and 825.4 mg/kg/day for females based on decreased
body weights, delayed preputial separation, and incomplete ossification
in the F1 and/or F2 males and females. |
870.4100 |
Chronic
toxicity-dogs |
NOAEL was
1.7 mg/kg/day for males and 1.5 mg/kg/day for females.
LOAEL was 8.1 mg/kg/day for males and
7.7 mg/kg/day for females based on body weight reductions and
hepatocytomegaly and cytoplasmic changes associated with increased
serum liver alkaline phosphatase indicative of cholestasis. |
870.4200
|
Carcinogenicity--mice |
NOAEL was
775.6 mg/kg bw/day for males
and 1265.1 mg/kg bw/day for females. No LOAEL
was identified. There was no evidence of carcinogenicity. |
870.4300
|
Combined
chronic toxicity / carcinogenicity--rats |
NOAEL was 53.0 mg/kg/day for males and 181.3 mg/kg/day for females.
LOAEL was 271.9 mg/kg/day for
males and
1083.2 mg/kg/day for females was based on decreased
body weight, decreased body weight gain, and decreased food
efficiency in both sexes; decreased spleen
weight in males; and microscopic lesions in the uterus of females.
The apparent increase in tumors in the uterus and thyroid were
addressed and resolved by an Agency committee, which
concluded that no carcinogenic concern exists for fluoxastrobin. |
870.6200
|
Acute neurotoxicity--
screening battery--rats |
Neurotoxicity
NOAEL was greater than or equal to 2,000 mg/kg (limit dose).
No LOAEL was identified. |
870.6200
|
Subchronic
neurotoxicity screening battery--rats |
Systemic
NOAEL (systemic and neurotoxic) was 473.9/582.4 mg/kg/day for
males and females, respectively. No LOAEL was identified. |
870.5100 |
Gene Mutation-in
vitro bacterial reverse gene mutation |
Negative
(considered non-mutagenic in Salmonella typhimurium cultures
treated up to cytotoxic/ precipitating levels). |
870.5100
|
Gene Mutation--in
vitro bacterial reverse gene mutation (the test substance was
HEC 5725N
(E:Z ratio of 90%:10%) |
Negative
(considered non-mutagenic in this Salmonella typhimurium/microsome
test). |
870.5100
|
Gene Mutation--in
vitro bacterial reverse gene mutation (the test substance was
HEC 5725-phenoxy-hydroxy-pyrimidine) |
Negative
(considered non-mutagenic in this Salmonella typhimurium/mammalian
activation gene mutation assay). |
870.5100
|
Gene Mutation--in
vitro bacterial reverse gene mutation (the test substance was
HEC 5725- dihydroxy- pyrimidine) |
Negative
(considered non-mutagenic in this Salmonella typhimurium/mammalian
activation gene mutation assay). |
870.5300
|
Gene mutation-in
vitro mammalian forward gene mutation |
Negative
(considered non-mutagenic in this in vitro forward mutation
V79-HPRT test). |
870.5375
|
Gene Mutation--in
vitro mammalian chromosome aberrations in Chinese hamster lung
(V79) cells |
Negative
(considered to be negative for clastogenicity in this in vitro
mammalian cell test). |
870.5395
|
Cytogenics-in
vivo mammalian cytogenetics - micronucleus assay (mouse) |
Negative
(considered non-clastogenic, as indicated by no increases in
micronuclei in bone marrow). |
870.7485 |
Metabolism
and pharmacokinetics-rat |
Absorption,
distribution, and metabolism were fully characterized in several
rat
metabolism studies using each of the three \14\C-radiolabeled
rings in fluoxastrobin. Absorption was almost complete following
a single oral low dose. Peak plasma concentrations were attained
within 0.5 to 8 hours depending on the dose and label position.
Fecal excretion was the major route of elimination while renal
excretion was a secondary route and elimination via expired
air was negligible. Fluoxastrobin was extensively metabolized
as evidenced by the extensive metabolite profiles from urine,
feces, and bile and the relative absence of parent compound
(except in the feces of rats given the high dose). |
870.7600 |
Dermal
penetration--monkey |
Following
an 8-hour dermal application in a male monkey, absorption was
negligible (1.16% preliminary, 2.16% main). The normalized absorption
value for the main study was 2.31%. |
870.7800 |
Immunotoxicity-mouse
(subacute feeding study) |
No clinical
signs of toxicity or mortality were found and no treatment-related
effects were found on body weight, food intake, or B-cell activated,
T-cell
mediated IgM response to SRBC. Based on these findings, and
findings in the 90-day oral rat study (no difference between
the control and treated animals in spleen cell count, macrophage
activities after PMA stimulation and plaque-forming cell assay
after challenge with sheep erythrocytes), it was concluded that
fluoxastrobin is not immunotoxic. However, the
study is considered unacceptable because of uncertainty in dietary
test material intake, failure to report spleen weight of each
mouse at necropsy, and failure of the laboratory to demonstrate
its capability in performing this type of assay. |
B. Toxicological Endpoints
The highest 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 level of concern
(LOC). However, the lowest dose at which adverse effects of concern
are
identified (the LOAEL) is sometimes used for risk assessment if
no
NOAEL was achieved in the toxicology study selected. An uncertainty
factor (UF) is applied to reflect uncertainties inherent in the
extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population
as well
as other unknowns. An UF of 100 is routinely used, 10X to account
for
interspecies differences and 10X for intraspecies differences.
Three other types of safety or uncertainty factors may be used:
``Traditional uncertainty factors;'' the ``special FQPA safety
factor;'' and the ``default FQPA safety factor.'' By the term
``traditional uncertainty factor,'' EPA is referring to those
additional uncertainty factors used prior to FQPA passage to account
for database deficiencies. These traditional uncertainty factors
have
been incorporated by the FQPA into the additional safety factor
for the
protection of infants and children. The term ``special FQPA safety
factor'' refers to those safety factors that are deemed necessary
for
the protection of infants and children primarily as a result of
the
FQPA. The ``default FQPA safety factor'' is the additional 10X safety
factor that is mandated by the statute unless it is decided that
there
are reliable data to choose a different additional factor
[[Page 54644]]
(potentially a traditional uncertainty factor or a special FQPA
safety
factor).
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 an UF
of
100 to account for interspecies and intraspecies differences and
any
traditional uncertainty factors deemed appropriate (RfD = NOAEL/UF).
Where a special FQPA safety factor or the default FQPA safety factor
is
used, 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 safety factor.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the LOC. For example, when 100 is the appropriate UF
(10X
to account for interspecies differences and 10X for intraspecies
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL
to
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated
and
compared to the LOC.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The
Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk). An example of how such a probability risk is expressed
would be to describe the risk as one in one hundred thousand (1
X
10-\5\), one in a million (1 X 10-\6\), or one in
ten million (1 X 10-\7\). 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 fluoxastrobin used
for
human risk assessment is shown in Table 2. of this unit:
Table
2.--Summary of Toxicological Dose and Endpoints for Fluoxastrobin
for Use in Human Risk Assessment |
Exposure
Scenario |
Dose
Used in Risk
Assessment; Interspecies, Intraspecies, and any Traditional
UF |
Special
FQPA SF and Level of Concern for Risk Assessment |
Study
and Toxicological Effects |
Acute Dietary |
NOAEL =
None |
Not applicable
|
There was
no indication of an adverse effect
attributable to a single dose. An aRfD was not established. |
Chronic
Dietary (all populations) |
NOAEL =
1.5 mg/kg/day
UF = 100X.............. |
Special
FQPA SF = 1X
cPAD = 0.015 mg/kg/day. |
Chronic
Toxicology-Dog
LOAEL = 8.1 mg/kg/day
for males and 7.7 mg/
kg/day for females based on body weight
reductions, hepatocytomegaly, and cytoplasmic changes
associated with increased serum liver alkaline phosphatase that
is indicative of cholestasis. |
Incidental
Short-Term Oral (1-30 days) |
NOAEL =
3.0 mg/kg/day
UF = 100X.............. |
Residential
LOC for MOE = 100 |
90-Day
Subchronic Oral Toxicology-Dog
LOAEL = 24.8 mg/kg/day (800 ppm) for males and 24.2 mg/kg/day
(800 ppm) for females based on dose-related
reductions in net body weight gain and food efficiency; toxicity
findings in the liver (cholestasis) in both sexes; and toxicity
findings in the kidneys (increased relative weights in females
and degeneration of the proximal tubular epithelium in males). |
Incidental
Intermediate-Term Oral (1- 6 months) |
NOAEL =
3.0 mg/kg/day
UF = 100X.............. |
Residential
LOC for MOE = 100 |
90-Day
Subchronic Oral Toxicology-Dog
LOAEL = 24.8 mg/kg/day (800 ppm) for males and 24.2 mg/kg/day
(800 ppm) for females based on dose-related
reductions in net body weight gain and food efficiency; toxicity
findings in the liver (cholestasis) in both sexes; and toxicity
findings in the kidneys (increased relative weights in females
and degeneration of the proximal tubular epithelium in males). |
Short-Term
Dermal (1-30 days) |
Not applicable |
None |
None: A
28-day dermal toxicity study in the rat was negative up to the
limit dose and there are no developmental or
neurotoxicity concerns. |
Intermediate-Term
Dermal (1-6 months) |
NOAEL =
3.0 mg/kg/day
UF = 100X.............. |
Residential
LOC for MOE = 100 |
90-Day
Subchronic Oral Toxicology-Dog
Dermal absorption rate LOAEL = 24.8 mg/kg/day = 2.3%. (800 ppm)
for males
and 24.2 mg/kg/day (800 ppm) for females
based on dose-related reductions in net
body weight gain and food efficiency; toxicity findings in the
liver (cholestasis) in both sexes; and toxicity findings in
the kidneys (increased relative weights in
females and degeneration of the
proximal tubular epithelium in males). |
Long-Term
Dermal (greater than 6 months) |
NOAEL =
1.5 mg/kg/day
UF = 100X.............
Dermal absorption rate = 2.3%. |
Residential
LOC for MOE = 100 |
Chronic
Toxicology-Dog LOAEL = 8.1 mg/kg/day for males and 7.7 mg/
kg/day for females based on body weight
reductions, hepatocytomegaly, and cytoplasmic changes associated
with increased serum liver alkaline phosphatase that is indicative
of cholestasis. |
Short-Term
Inhalation (1-30 days) |
NOAEL =
3.0 mg/kg/day
UF = 100X.............. |
Residential
LOC for MOE = 100 |
90-Day
Subchronic Oral Toxicology-Dog
LOAEL = 24.8 mg/kg/day (800 ppm) for males and 24.2 mg/kg/day
(800 ppm) for females based on dose-related
reductions in net body weight gain and food efficiency; toxicity
findings in the liver (cholestasis) in both sexes; and toxicity
findings in the kidneys (increased relative weights in females
and degeneration of the proximal tubular epithelium in males). |
Intermediate-Term Inhalation (1-6 months) |
NOAEL =
3.0 mg/kg/day
UF = 100X.............. |
Residential
LOC for MOE = 100 |
90-Day
Subchronic Oral Toxicology-Dog
LOAEL = 24.8 mg/kg/day (800 ppm) for males and 24.2 mg/kg/day
(800 ppm) for females based on dose-related
reductions in net body weight gain and food efficiency; toxicity
findings in the liver (cholestasis) in both sexes; and toxicity
findings in the kidneys (increased relative weights in females
and degeneration of the proximal tubular epithelium in males). |
Long-Term
Inhalation (greater than 6 months) |
NOAEL =
1.5 mg/kg/day
UF = 100X.............. |
Residential
LOC for MOE = 100 |
Chronic
Toxicology-Dog
LOAEL = 8.1 mg/kg/day for males and 7.7 mg/kg/day for females
based on body weight reductions, hepatocytomegaly,
and
cytoplasmic changes associated with
increased serum liver alkaline phosphatase that is indicative
of cholestasis. |
Cancer
(oral, dermal, inhalation) |
Classification:
Not likely to be carcinogenic to humans. |
C. Exposure Assessment
1. Dietary exposure from food and feed uses. As is described in
Unit II., tolerances for fluoxastrobin are being established on
a
variety of raw agricultural commodities. Risk assessments were
conducted by EPA to assess dietary exposures from fluoxastrobin
in food
as follows:
i. Acute exposure. Acute dietary risk assessments are performed
for
a food-use pesticide, if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a one-day
or single exposure. The toxicological database for fluoxastrobin
identified no adverse effect attributable to a single dose, therefore
an acute dietary exposure assessment was not performed.
ii. Chronic exposure. In conducting the chronic dietary risk
assessment EPA used the Dietary Exposure Evaluation Model software
with
the Food Commodity Intake Database (DEEM-FCID\TM\ version 2.0) and
the
Lifeline\TM\ model, version 2.0, both of which incorporate food
consumption data as reported by respondents in the USDA 1994-1996
and
1998 Nationwide Continuing Surveys of Food Intake by Individuals
(CSFII). The assumptions made for the chronic dietary exposure
assessments were that residues, for all commodities, were present
at
100% of the tolerance levels and fluoxastrobin was applied to 100%
of
each crop to which it may be applied.
[[Page 54646]]
2. Dietary exposure from drinking water. The Agency does not have
drinking water monitoring exposure data to use in a comprehensive
dietary exposure analysis and risk assessment for fluoxastrobin,
a new
pesticidal chemical. Because of this the Agency made drinking water
concentration estimates by use of simulation or modeling, which
takes
into account data on the physical and chemical characteristics of
fluoxastrobin.
The Agency used the Pesticide Root Zone Model/Exposure Analysis
Modeling System (PRZM/EXAMS (PRZM version 3.12 beta and EXAMS version
2.98.04)), to produce estimates of pesticide concentrations in an
index
reservoir (the surface water concentration estimates). The Screening
Concentrations in Ground Water (SCI-GROW) model was used to predict
pesticide concentrations in shallow ground water (the ground water
concentration estimates). The surface water concentration analysis
was
based on the turf use, which has the highest labeled annual application
rate and assumes the highest default value of 87% percentage cropped
area (PCA) land use around the index reservoir. The assumptions
in this
analysis are therefore also conservative. The ground water
concentration analysis was based on the maximum pesticide use rate
(the
turf use again), the persistence of fluoxastrobin in soil, and the
ability of fluoxastrobin to leach.
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 screen for sorting out pesticides for which
it is
unlikely that drinking water concentrations would exceed human health
levels of concern.
Estimated drinking water concentrations (EDWCs) derived from these
models are used to calculate drinking water levels of comparison
(DWLOCs). The DWLOCs are used as points of comparison against the
EDWCs. DWLOCs are theoretical upper limits on the concentration
of a
pesticide that could occur in drinking water without exceeding the
size
of the risk cup, considering the aggregate exposure to that pesticide
in food and from residential uses. Since DWLOCs represent maximum
allowable exposure to fluoxastrobin in drinking water, they are
further
discussed in the aggregate risk sections in Unit III.E.
Based on the PRZM/EXAMS and SCI-GROW models, the EDWCs of
fluoxastrobin for acute exposures are 28 parts per billion (ppb)
for
surface water and less than 1 ppb for ground water. The EDWCs for
chronic exposures are 14 ppb for surface water and less than 1 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).
There is potential for homeowner exposure
to fluoxastrobin in
residential settings by entry to turf areas where this fungicide
has
previously been applied, such as lawns where children might play
or
golf courses that adults might be active on. Therefore, risk
assessments have been performed for residential postapplication
scenarios. However, only professional pest control operators will
be
allowed to make the turf applications so residential handler exposure
was not evaluated.
Since chemical-specific data were unavailable, the Agency used
general current approaches for non-occupational assessment and believes
that the calculated risks represent screening level estimates. Maximum
application rates have been used for all scenarios, and the risk
estimates assume no dissipation of residues after day zero and do
not
consider removal of residues as a result of periodic cutting of
the
grass. Additionally, the intermediate-term endpoint was used for
dermal
risk estimates, even though the non-occupational exposure duration
is
believed to mostly be short-term (as a result of the use pattern),
because no short-term dermal toxicity endpoint was identified.
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 fluoxastrobin and 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 not assumed that fluoxastrobin
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 web site
at
http://www.epa.gov/pesticides/cumulative/.
D. Safety Factor for Infants and Children
1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional tenfold margin of safety for infants and children
in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines based on reliable data that a different margin
of
safety will be safe for infants and children. Margins of safety
are
incorporated into EPA risk assessments either directly through use
of a
MOE analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans.
In
applying this provision, EPA either retains the default value of
10X
when reliable data do not support the choice of a different factor,
or,
if reliable data are available, EPA uses a different additional
safety
factor value based on the use of traditional uncertainty factors
and/or
special FQPA safety factors, as appropriate.
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 post-natal sensitivity.\
3. Conclusion. There is a complete toxicity data base for
fluoxastrobin and exposure data are complete or are estimated based
on
data that reasonably accounts for potential exposures. The
Agency
therefore has recommended reducing the special FQPA SF to 1X,
based on
the following additional considerations. First, there are no low
risk
concerns indicated by the various hazard studies. The study data
are of
high quality, and there are no residual uncertainties with regard
to
the pre- and/or postnatal toxicity of this chemical. Second, the
dietary food exposure assessment utilizes proposed tolerance level
or
higher residues and 100% crop treated information for all commodities.
By using these screening-level assessments, chronic exposures and
risks
will not be underestimated.
[[Page 54647]]
Third, the dietary drinking water assessments utilize values generated
by models and associated modeling parameters which are designed
to
provide conservative, health protective, high-end estimates of water
concentrations. Fourth, the residential exposure assessment utilizes
activity-specific transfer coefficients and turf transferable residues
(TTR), as well as maximum application rates for the postapplication
scenario. The residential assessment is based on reliable data and
is
unlikely to underestimate exposure/risk.
E. Aggregate Risks and Determination of Safety
To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against EDWCs. DWLOC values
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, not regulatory standards for drinking water .
In
calculating a DWLOC, the Agency determines how much of the acceptable
exposure (i.e., the PAD) is available for exposure through drinking
water [e.g., allowable chronic water exposure (mg/kg/day) = cPAD
-
(average food + residential exposure)]. This allowable exposure
through
drinking water is the source of the 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 EDWCs for surface water and ground water are less than the
calculated DWLOCs, OPP concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which OPP has reliable data)
would
not result in unacceptable levels of aggregate human health risk
at
this time. Because OPP 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, OPP will reassess the potential impacts
of residues of the pesticide in drinking water as a part of the
aggregate risk assessment process.
1. Acute risk. The toxicological database for fluoxastrobin
identified no adverse effect attributable to a single dose, therefore
fluoxastrobin is not expected to pose an acute dietary risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
fluoxastrobin from food will utilize 10% of the cPAD for the U.S.
population, 6% of the cPAD for all infants less than 1 year old,
and
25% of the cPAD for children 1 to 2 years old, the children
subpopulation with the greatest exposure. Based on the use pattern,
chronic residential exposure to residues of fluoxastrobin is not
expected. However, there is the potential for chronic dietary exposure
to fluoxastrobin in drinking water. After calculating DWLOCs and
comparing them to the EDWCs for surface and ground water, 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 Fluoxastrobin |
Population
Subgroup |
cPAD mg/kg/day
|
% cPAD
(Food) |
Surface
Water EDWC (ppb) |
Ground\
Water EDWC (ppb) |
Chronic
DWLOC (ppb) |
U.S. population |
0.015 |
10 |
14 |
< 1 |
470 |
3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposures both take into account residential exposure
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 dermal exposure
estimates (i.e., the highest exposure estimates).
Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that food and
residential exposures aggregated result in aggregate MOEs of 1,000
for
the U.S. population, 1,100 for females 13-49 years old, and 180
for
children 1-2 years old. These aggregate MOEs do not exceed the Agency's
level of concern for aggregate exposure to food and residential
uses.
In addition, short- and intermediate-term DWLOCs were calculated
and
compared to the EDWCs for chronic exposure to fluoxastrobin in ground
and surface water. After calculating DWLOCs and comparing them to
the
EDWCs for surface and ground water, EPA does not expect short- and
intermediate-term aggregate exposure to exceed the Agency's level
of
concern, as shown in Table 4. of this unit:
[[Page 54648]]
Table
4.--Aggregate Risk Assessment for Short- and Intermediate-Term
Exposure to Fluoxastrobin |
Population
Subgroup |
Aggregate
MOE (Food + Residential) |
Aggregate
Level of Concern (LOC) |
Surface
Water EDWC (ppb) |
Ground
Water EDWC (ppb) |
Short-
and
Intermediate- Term DWLOC (ppb) |
U.S. population |
1,000 |
100 |
28 |
< 1 |
940 |
4. Determination of safety. Based on these risk assessments,
EPA
concludes that there is a reasonable certainty that no harm will
result
to the general population, and to infants and children from aggregate
exposure to fluoxastrobin residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (liquid chromatography/mass
spectrometry/mass spectrometry methods) is available to enforce
the
tolerance expression. The methods are LC/MS/MS Method No. 00604,
entitled ``Analytical Determination of Residues of the Fungicide
HEC
5725 In/On Cereals, Cereal Processed Products and Vegetables by
HPLC-
MS/MS [high-pressure liquid chromatography--mass spectrometry/mass
spectrometry],'' and LC/MS/MS Method No. 00649, entitled ``Analytical
Method 00649 for the Determination of Residues of HEC 5725 In/On
Matrices of Plant Origin by HPLC-MS/MS.'' 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 Mexican, Canadian, nor CODEX maximum residue
limits established for fluoxastrobin.
C. Conditions
The following conditions are being imposed
on Bayer CropScience
(the petitioner) for the registration of fluoxastrobin.
1. Submit additional information concerning weather conditions,
confirmatory raw data, and soil characteristics data for the crop
field
trial and field rotational crop studies.
2. Submit additional data concerning the chromatograms and
chromatography in the goat metabolism study.
3. The enforcement methods must be rewritten to include
instructions for the analysis of all crops, and to specify the
additional ions to be monitored for quantitation.
4. A new peanut processing study must be submitted.
5. Submit reference standard materials for fluoxastrobin and
several molecules related to it, including isotopically labeled
internal standard reference materials, to the EPA National Pesticide
Standards Repository.
6. Submit additional information concerning the grass forage and
hay rotational crop field trials.
7. Submit confirmatory data and additional information concerning
the storage stability data.
8. Submit additional information concerning the mouse
immunotoxicity subacute feeding study.
V. Comments
In response to the notice of filing one communication was received
from Susie Wilcher in the role of private citizen and one
communication, undersigned by Ellen Connett, was received from the
Fluoride Action Network (FAN). The communications objected to
establishment of the proposed tolerances for several reasons, some
of
them specific and others involving generalized and unsubstantiated
disagreement with EPA's risk assessment methodologies or safety
findings.
Ms. Wilcher's comments contained general objections to the use of
pesticides on food and to the use of animal testing to determine
the
safety of pesticides. The Agency understands the commentor's concerns
and recognizes that some individuals believe that pesticides should
be
banned completely. However, under the existing legal framework provided
by section 408 of the FFDCA EPA is authorized to establish pesticide
tolerances or exemptions where persons seeking such tolerances or
exemptions have demonstrated that the pesticide meets the safety
standard imposed by that statute.
The Agency disagrees with the commenter's objections to animal
testing. Since humans and animals have complex organ systems and
mechanisms for the distribution of chemicals in the body, as well
as
processes for eliminating toxic substances from their systems, EPA
relies on laboratory animals such as rats and mice to mimic the
complexity of human and higher-order animal physiological responses
when exposed to a pesticide. EPA is committed, however, to reducing
the
use of animals whenever possible. EPA-required studies include animals
only when the requirements of sound toxicological science make the
use
of an animal absolutely necessary. The Agency's goal is to be able
to
predict the potential of pesticides to cause harmful effects to
humans
and wildlife by using fewer laboratory animals as models and have
been
accepting data from alternative (to animals) test methods for several
years. As progress is made on finding or developing non-animal test
models that reliably predict the potential for harm to humans or
the
environment, EPA expects that it will need fewer animal studies
to make
safety determinations.
FAN submitted a number of different comments. First,
FAN asked
whether fluoxastrobin was already registered in the United States
and
what are the names of the fluoxastrobin products used on residential
turf and golf courses. Fluoxastrobin is not currently registered
but
with the completion of this tolerance regulation that registration
should be granted shortly. To the best of EPA's knowledge,
the product
name under which fluoxastrobin is marketed for turf and golf course
use
is HEC 480 SC Fungicide.
Second, FAN suggested
that a 14-week feeding study using dogs
showed an effect on the thyroid, which seems to conflict with the
statement that ``...There is no evidence to suggest that fluoxastrobin
has any primary
[[Page 54649]]
endocrine disruptive potential.'' FAN stated
that a ``discussion or
rationale'' addressing this should have been provided. EPA does
believe
that the thyroid effects seen in the dog study indicated that
fluoxastrobin is an endocrine disruptor. An effect on the thyroid
gland, even though this gland is part of the endocrine system, does
not
necessarily mean that endocrine disruption has or will occur. In
this
case, the effects observed in the thyroid gland were induced by
effects
fluoxastrobin had on liver enzymes and are therefore considered
secondary.
Third, FAN claimed that a ``fuller
discussion and description of
the metabolites of fluoxastrobin should have been presented.'' The
notice states: ``The residue of concern is parent fluoxastrobin
(sum of
E and Z isomers).'' According to the Compendium of Pesticide Common
Names, Fluoxastrobin ``was provisionally approved for the (EZ)-isomer
[193740-76-0] in April 2002. The definition was changed to the (E)-
isomer in January 2003 at the request of the sponsor...Because of
this
change it is not clear from the information supplied in this notice
what isomer/metabolite are of concern.''
Fluoxastrobin is the accepted common name
for the pesticidally
active E-isomer of (2-[6-(2-chlorophenoxy)-5-fluoro-4-pyrimidinyl]oxy
phenyl)-5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-methyloxime.
The Z-
isomer of fluoxastrobin is typically present at much lower levels
(E:Z
ratio of approximately 90:10). Additionally, the Z-isomer of
fluoxastrobin is considered to be a metabolite (photo-degradate)
of
fluoxastrobin. The CAS Number Bayer CropScience initially obtained
for
fluoxastrobin pertained to both isomers combined. After consultation
with the Agency, the petitioner requested that fluoxastrobin (the
pesticidally active E-isomer only) be designated as the active
ingredient. The tolerances that are being established today include
both fluoxastrobin (i.e. the E-isomer) and the Z-isomer and the
risk
assessment for these tolerances was based on exposures resulting
from
both isomers.
Fourth, FAN requested that the Agency
begin to incorporate the
Chemical Abstract Service (CAS) numbers for ``every chemical, and
its
metabolite(s)'' in ``all future reports, especially those published
in
the Federal Register.'' EPA is evaluating the feasibility of such
a
step. EPA would note, however, that not every molecule or substance
has
a CAS number. Many metabolites do not have a CAS number, for example,
because no application for a CAS number was made or is required.
CAS is
also often not willing to assign CAS numbers to substances it believes
are not able to be characterized well enough (some petroleum
distillates, for example). In addition, CAS numbers may be
inappropriate in some types of reports. However, the CAS number
could
be a useful identifier in certain documents for molecules which
have one.
FAN also commented that the data references cited in the notice
of
filing were not available in the docket, and that without this
information, it was not possible to comment on the findings presented.
In response, the Agency transmitted to FAN the human health risk
assessment and the toxicological studies used in that risk assessment.
VI. Conclusion
Therefore, tolerances requested for fluoxastrobin in the revised
petition are established.
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 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-2003-0129 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 November
15, 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 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on
which a
hearing is requested, the requestor's contentions on such issues,
and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of
that
information as CBI. Information so marked will not be disclosed
except
in accordance with procedures set forth in 40 CFR part 2. A copy
of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (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 docket ID number OPP-2003-0129, 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 he
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
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:
[[Page 54650]]
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 issue(s) in the manner sought
by the requestor would be adequate to justify the action requested
(40
CFR 178.32).
VIII. 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 rule has been
exempted from review under Executive Order 12866 due to its lack
of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy
Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule
does
not contain any information collections subject to OMB approval
under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described
under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public
Law
104-4). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental
Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action
does
not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act of
1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).
Since
tolerances and exemptions that are established on the basis of a
petition under section 408(d) of 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 FFDCA. For these same reasons,
the
Agency has determined that this rule does not have any ``tribal
implications'' as described in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (59
FR 22951,
November 6, 2000). Executive Order 13175, requires EPA to
develop an accountable process to ensure ``meaningful and timely
input
by tribal officials in the development of regulatory policies that
have
tribal implications.'' ``Policies that have tribal implications''
is
defined in the Executive order to include regulations that have
``substantial direct effects on one or more Indian tribes, on the
relationship between the Federal Government and the Indian tribes,
or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes.'' This rule will not have substantial
direct effects on tribal governments, on the relationship between
the
Federal Government and Indian tribes, or on the distribution of
power
and responsibilities between the Federal Government and Indian tribes,
as specified in Executive Order 13175. Thus, Executive Order 13175
does
not apply to this rule.
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: September 2, 2005.
James Jones,
Director, Office of Pesticide Programs.
• Therefore, 40 CFR part 180 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. Section 180.609 is added to read as follows:
Sec. 180.609 Fluoxastrobin; tolerances for residues.
(a) General. (1) Tolerances are established
for the combined
residues of fluoxastrobin, (1E)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-
pyrimydinyl]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-pyrimydinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone
O-
methyloxime, in or on the following raw agricultural commodities:
Commodity |
Parts
per million |
Leaf
petioles subgroup 4B
This
subgroup includes 8 commodities:
amaranth, leafy • cardoon • celery • celery,
chinese • celtuce • fennel, florence •
rhubarb • swiss chard
|
4.0 |
Peanut |
0.010 |
Peanut,
hay |
20.0 |
Peanut,
refined oil |
0.030 |
Tomato,
paste |
1.5 |
Vegetable,
fruiting, group 8
This
group includes 17 commodities:
chili, postharvest • eggplant • groundcherry
• pepino • pepper • pepper, bell •
pepper, nonbell • pepper, nonbell, sweet • tomatillo
• tomato • tomato, concentrated products •
tomato, dried pomace • tomato, paste • tomato,
puree • tomato, wet pomace • vegetable, fruiting
• vegetable, fruiting, group
|
1.0 |
Vegetable,
tuberous and corm, subgroup 1C
This
subgroup includes 22 commodities:
arracacha • arrowroot • artichoke, chinese •
artichoke, jerusalem • canna, edible • cassava
• chayote root • chufa • dasheen •
ginger • leren • potato • potato culls
• potato granules flakes • potato peel, wet
• potato processed potato waste • potato, specialty
• sweet potato • tanier • turmeric •
yam bean • yam, true
|
0.010 |
(2) Tolerances are established for the combined
residues of
fluoxastrobin, (1E)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-
pyrimydinyl]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-
pyrimydinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone
O-
methyloxime, and its phenoxy-
[[Page 54651]]
hydroxypyrimidine metabolite, 6-(2-chlorophenoxy)-5-fluoro-4-
pyrimidinol, in or on the following raw agricultural commodities:
Commodity |
Parts
per 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 combined residues
of fluoxastrobin,
(1E)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-pyrimydinyl]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-pyrimydinyl]oxy]phenyl](5,6-
dihydro-1,4,2-dioxazin-3-yl)methanone O-methyloxime, in or on the
following raw agricultural commodities when present therein as a
result
of the application of fluoxastrobin to the growing crops listed
in
paragraph (a)(1) of this section:
Commodity |
Parts
per million |
Alfalfa,
forage |
0.050 |
Alfalfa,
hay |
0.10 |
Cotton,
gin byproducts |
0.020 |
Grain,
cereal, forage, fodder, and straw, group
16
This
group includes 50 commodities:
barley, hay • barley, straw • corn, field •
corn, field, aspirated grain fractions • corn, field,
forage • corn, field, hay • corn, field, stover
• corn, pod • corn, pod, stover • corn,
pop • corn, pop, stover • corn, sweet, cannery
waste • corn, sweet, forage • corn, sweet, stover
• grain, cereal, forage, fodder and straw, group,
for forage, except sweet corn, forage • grain. cereal,
group • grass, hay • millet, forage •
millet, hay • millet, pearl, forage • millet,
pearl, hay • millet, pearl, straw • millet,
proso, forage • millet, proso, hay • millet,
proso, straw • millet, straw • oat • oat,
forage • oat, hay • oat, straw • rice,
forage • rice, hulls • rice, straw • rice,
wild • ricegrass, indian • rye, forage •
rye, straw • sorghum, forage • sorghum, forage,
forage • sorghum, forage, hay • sorghum, forage,
silage • sorghum, grain • sorghum, grain, forage
• sorghum, grain, stover • wheat, forage •
wheat, hay • wheat, straw • wheat, vavilovi,
straw • wheat, wild einkorn, straw • wheat,
wild emmer, straw
|
0.10 |
Grass,
forage |
0.10 |
Grass,
hay |
0.50 |
Vegetable,
foliage of legume, group 7
This
group includes 21 commodities:
bean, dry, forage • bean, dry, hay • bean, forage
• bean, hay • bean, lima, forage • bean,
lima, hay • bean, snap, forage • bean, straw
• cowpea, forage • cowpea, hay • legume,
forage • legume, forage, except soybean and peanut
• lupin, grain, forage • lupin, grain, hay •
pea, field, hay • pea, field, silage • pea,
field, vines • pea, pigeon, forage • vegetable,
seed and pod, fodder • vegetable, seed and pod, forage
• vegetable, seed and pod, hay
|
0.050 |
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[FR Doc. 05-18421 Filed 9-15-05; 8:45 am]
BILLING CODE 6560-50-S
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