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http://www.epa.gov/fedrgstr/EPA-PEST/2005/August/Day-31/p17128.htm
[Federal Register: August 31, 2005 (Volume 70, Number 168)]
[Rules and Regulations]
[Page 51604-51615]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31au05-10]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2005-0217; FRL-7731-6]
Flonicamid; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance for combined residues
of flonicamid and its metabolites in or on certain plant and livestock
commodities. ISK Biosciences requested this
tolerance under the Federal
Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality
Protection Act of 1996 (FQPA).
DATES: This regulation is effective August 31, 2005. Objections
and
requests for hearings must be received on or before October 31,
2005.
ADDRESSES: To submit a written objection or hearing request follow
the
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under
Docket
identification (ID) number OPP-2005-0217. 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: Ann Sibold, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection
Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-6502; e-mail address sibold.ann@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 underFOR 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 May 23, 2003 (68 FR 28218) (FRL-7307-5),
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 3F6552)
by ISK Biosciences, 7470 Auburn Road, suite A, Concord, Ohio 44077.
The
petition requested that 40 CFR part 180 be amended by establishing
a
tolerance for the combined residues of the insecticide flonicamid,
[N-
(cyanomethyl)-4-trifluoromethylnicotinamide] and its metabolites,
TFNA,
(4-trifluoromethylnicotinic acid), TFNA-AM, (4-
trifluoromethylnicotinamide) and TFNG, [N-(4-
trifluoromethylnicotinoyl)glycine] in or on the raw agricultural
commodities: Celery, at 1.2 parts per million (ppm); cotton, at
0.5
ppm; cotton, gin trash, at 6.0 ppm; cotton, hulls, at 1.0 ppm; cotton,
meal, at 1.0 ppm; fruit, pome, group 11, at 0.2 ppm; fruit, stone,
group 12, except plum and fresh prune plum, at 0.7 ppm; lettuce,
head,
at 1.0 ppm; lettuce, leaf, at 4.0 ppm; plum, at 0.1 ppm; potato,
at 0.2
ppm; potato, flakes, at 0.4 ppm; prune, fresh, at 0.1; spinach,
at 9.0
ppm; tomato, paste, at 2.0 ppm; tomato, puree, at 0.5 ppm; vegetable,
[[Page 51605]]
cucurbit, group 9, at 0.4 ppm; vegetable, fruiting, group 8, at
0.4
ppm; by establishing tolerances for the combined residues of the
insecticide flonicamid, [N-(cyanomethyl)-4-trifluoromethylnicotinamide]
and its metabolite TFNA-AM, (4-trifluoromethylnicotinamide) in animal
tissues and poultry meat byproducts:Cattle, fat, at 0.01 ppm; cattle,
meat, at 0.04 ppm; eggs, at 0.02 ppm; goat, fat, at 0.01 ppm; goat,
meat, at 0.04 ppm; hog, fat, at 0.01; hog, meat, at 0.01 ppm; horse,
fat, at 0.01 ppm; horse, meat, at 0.04 ppm; milk, at 0.02 ppm; poultry,
fat, at 0.01 ppm; poultry, meat, at 0.01 ppm; poultry, meat byproducts,
at 0.01 ppm; sheep, fat, at 0.01 ppm; sheep, meat, at 0.04 ppm;
by
establishing tolerances for the combined residues of the insecticide
flonicamid [N-(cyanomethyl)-4-trifluoromethylnicotinamide] and its
metabolites TFNA, (4-trifluoromethylnicotinic acid) and TFNA-AM,
(4-
trifluoromethylnicotinamide) in the animal meat byproducts: cattle,
meat byproducts, at 0.06 ppm; goat, meat byproducts, at 0.06 ppm;
hog,
meat byproducts, at 0.01 ppm; horse, meat byproducts, at 0.06 ppm;
and
sheep, meat byproducts, at 0.06 ppm. That notice included a summary
of
the petition prepared by ISK Biosciences, the registrant. One comment
was received on the notice of filing. EPA's response to this comment
is
discussed in Unit IV.C.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or
on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there
is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and
in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that
there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue.
. .
.''
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 a tolerance for combined residues of flonicamid
and its metabolites on various crop and livestock commodities at
levels
set forth in the list below.
Tolerances for combined residues of flonicamid and its metabolites
in/on crops and livestock commodities.
1. Recommended tolerances for combined residues
of flonicamid and
its metabolites TFNA, TFNG and TFNA-AM in/on crops.
Cotton, undelinted seed at 0.50 ppm
Cotton, gin byproducts at 6.0 ppm
Cotton, hulls at 2.0 ppm
Cotton, meal at 1.0 ppm
Fruit, pome, group 11 at 0.20 ppm
Fruit, stone, group at 12 0.60 ppm
Potato 0.20 at ppm
Potato, granular/flakes at 0.40 ppm
Spinach at 9.0 ppm
Tomato, paste at 2.0 ppm
Tomato, puree at 0.50 ppm
Vegetable, cucurbit, group at 0.40 ppm
Vegetable, fruiting, group at 0.40 ppm
Vegetable, leafy except Brassica group 4, except spinach at 4.0
ppm
2. Recommended tolerances for combined residues
of flonicamid and
its metabolites TFNA and TFNA-AM in/on livestock commodities.
Cattle, fat at 0.02 ppm
Cattle, meat at 0.05 ppm
Egg at 0.03 ppm
Goat, fat at 0.02 ppm
Goat, meat at 0.05 ppm
Horse, fat at 0.02 ppm
Horse, meat at 0.05 ppm
Milk at 0.02 ppm
Poultry, fat at 0.02 ppm
Poultry, meat at 0.02 ppm
Poultry, meat byproducts at 0.02 ppm
Sheep, fat at 0.02 ppm
Sheep, meat at 0.05 ppm
Cattle, meat byproducts at 0.08 ppm
Goat, meat byproducts at 0.08 ppm
Horse, meat byproducts at 0.08 ppm
Sheep, meat byproducts at 0.08 ppm
EPA's assessment of exposures and risks associated with
establishing the tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship
of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants
and
children. Specific information on the studies received and the nature
of the toxic effects caused by flonicamid 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 Table 1
of
this unit.
[[Page 51606]]
Table
1.--Subchronic, Chronic and Other Toxicity of Flonicamid |
Guideline
No. |
Study Type
|
Dose Levels
|
Results |
870.3100 |
90-Day
oral toxicity rodents (rats)
28-day range-finding |
0,
50 (males), 200, 1,000,2,000 (males), or 5,000 (females) ppm
(3.08, 12.11,60.0, or 119.4 mg/kg/day, males and 14.52, 72.3,
or 340.1 mg/kg/day,
0, 50 (males), 100, 500, 1,000,5,000 or 10,000 (females) ppm
(3.61, 7.47, 36.45,73.8, or 353.4 mg/kg/day, males and 8.36,
41.24, 81.9,372.6, or 642 mg/kg/day,females). |
NOAEL is
200 ppm (12.11 mg/ kg/day) for males and 1,000 ppm (72.3 mg/kg/day)
for females
LOAELs were 1,000 ppm (60.0 mg/kg/day) for males based on changes
in the kidney (hyaline deposition) and 5,000 ppm (340 mg/kg/day)
for females based on kidney (hyaline deposition)
and liver changes (centrilobular hypertrophy)
NOAEL is 100 ppm (7.47 mg/kg/day) for males and 1,000 ppm (81.9
mg/kg/day) for females.
LOAELs were 500 ppm (36.45 mg/kg/day) for males based on changes
in the kidney (hyaline deposition)
and 5,000 ppm for females (372.6mg/kg/day) based on kidney
(hyaline deposition), liver changes
(centrilobularhypertrophy), hematological effects (anemia)
and clinical chemistry (increased cholesterol) |
870.3100 |
90-Day
oral toxicity rodents (mice) |
0,
100, 1,000 or 7,000 ppm (0, 15.25, 153.9 or 1,069mg/kg bw/day
in males,and 0, 20.10, 191.5, or 1,248 mg/kg bw/day in females)
|
NOAEL is
100 ppm (males: 15.25 mg/kgbw/day, females: 20.10 mg/kg bw/
day)
LOAEL is 1,000 ppm in (males: 153.9 mg/kgbw/day; females: 191.5
mg/kg bw/ day) based on extramedullary
hematopoiesis of the spleen
Many of the tissues/organs recommended
by Guideline 870.3100 were not histologically examined in any
dose group, but this study is not required and serves
as a range-finding study for the mouse carcinogenicity study.Therefore,
it is classified as acceptable, non-guideline study |
870.3150
|
90-Day
oral toxicity (nonrodents- dogs) |
0,
3, 8, 20, or 50 (females) mg/kg bw/ day |
NOAEL is
8 mg/kg/day in males and 20 mg/kg/day for female
LOAEL is 20 mg/kg/day in males and 50 mg/kg/day in females,
based on acute clinical signs in males and females (vomiting,
first observed on Day 1 and last observed on Day 90), clinical
pathology at 7 weeks (increased total
protein levels in males, lower red blood cells and higher reticulocytes
counts in females), increased adrenal
weights in males,
decreased thymus gland weights in males,
and increased kidney tubular vacuolation
in females at study termination |
870.3200
|
28-Day
dermal toxicity (rats) |
0,
20, 150, or 1,000 mg/kg/day |
NOAEL is
1,000 mg/kg/day
LOAEL is >1,000 mg/kg/day |
870.3700
|
Prenatal
developmental toxicity (rats) |
0,
20, 100 or 500 mg/ kg bw/day |
Maternal
NOAEL is 100 mg/kg bw/day
LOAEL is 500 mg/kg bw/day,
based on increased liver weight,
and liver and kidney
pathological changes (hypertrophy of centrilobular
hepatocytes in liver and vacuolation of proximal tubular cell
in kidneys)
Developmental
NOAEL is 100 mg/kg bw/day
LOAEL is 500 mg/kg bw/day,
based on the increased incidence of cervical
rib |
870.3700 |
Prenatal
developmental toxicity (rabbits) |
0,
2.5, 7.5, or 25 mg/ kg/day |
Maternal
NOAEL is 7.5 mg/kg/day
LOAEL is 25 mg/kg, based on
decreased body weights, body weight gains,
and food consumption
Developmental
NOAEL is >= 25 mg/kg/day
LOAEL is not established |
870.3800
|
Reproduction
and fertility effects (rats) |
0,
50, 300, or 1,800 ppm (0/0, 3.7/4.4, 22.3/26.5, and132.9/ 153.4
mg/kg bw/day [M/ F] |
Parental
NOAEL is 50 ppm (equivalent to 3.7/4.4mg/kg/day [M/F]
LOAEL is 300 ppm (equivalent to 22.3/26.5mg/ kg/day [M/F] based
on increased relative kidney weight
and hyaline droplet depositionin
the proximal tubules of the kidneys in the males and increased
blood serum LH levels in the F1 females
Offspring
NOAEL is 300 ppm (equivalent to 22.3/26.5mg/ kg/day [M/F].
LOAEL is 1,800 ppm(equivalent to 132.9/153.4 mg/kg/day [M/ F]
based on decreased absolute and relative to body uterus
weights and delayed sexual maturation
in the F1 females
Reproductive Performance
NOAEL is 1,800 ppm (equivalent to 132.9/ 153.4mg/kg/day [M/F]
LOAEL for reproductive performance was not observed |
870.4100
|
Chronic
toxicity (dogs) |
0,
3, 8, or 20 mg/kg/ day |
NOAEL is
8 mg/kg/day
LOAEL is 20 mg/kg/day,
based on acute clinical signs(vomiting, mostly within the first
week), clinical pathology at 12 months (higher
reticulocytes counts) in males and females |
870.4200
|
Carcinogenicity
(mice) |
0,
250, 750, or 2250 ppm (0/0, 29/38, 88/ 112, or 261/334 mg/kg/day
[M/F] |
NOAEL was
not established
LOAEL is 250 ppm (equivalent to 29/38mg/kg/ day [M/F]), based
on minimal to moderate centrilobular hepatocellular
hypertrophy, minimal to severe
extramedullary hematopoiesis, minimal to moderate pigment
deposition in the sternal bone marrow, and increased
incidence of tissue masses/nodules in the lungs in the males,
and minimal to moderate decreased cellularity
in the femoral bone marrow and hyperplasia/hypertrophy
of the epithelial cells of the terminal bronchioles of the females.
At the doses tested, the carcinogenic potential of IKI-220 (flonicamid)
is positive at 250 ppm in males and females based on the increased
incidence of alveolar/bronchiolar adenomas, carcinomas, and
combined adenomas/carcinomas. Dosing was considered adequate
based on increased incidence of tissue masses/nodules in the
lungs and microscopic findings in the liver, spleen, bone marrow,
and lungs. However, data were provided suggesting this effect
is specific to sensitive strains of mice. Carcinogenic
in mice. |
870.4200 |
Carcinogenicity
(mice) |
0,
10, 25, 80, 250 ppm males: 0, 1.20, 3.14, 10.0,30.3 mg/kg/ day;
females: 0,1.42, 3.67, 11.8, 36.3 mg/ kg/day |
NOAEL is
80 ppm (equivalent to 10/12 mg/kg/day in males/females)
LOAEL is 250 ppm (equivalent to 30/36mg/kg/day in males/females)
based on lung masses and terminal bronchiole
epithelial cellhyperplasia/ hypertrophy in both sexes.
At the doses tested, the carcinogenic
potential of IKI-220 (flonicamid) is positive in males and females
based on the incidences of alveolar/ bronchiolar adenomas, carcinomas,and
combined adenomas and/or carcinomas. Dosing was considered
adequate based on lung masses and terminal bronchiole epithelialcell
hyperplasia/ hypertrophy in both sexes. Carcinogenic
in mice. |
870.4300 |
Combined
Chronic/ carcinogenicity (rats) |
0,
50 (males), 100 (males), 200, 1,000, or 5,000 (females) ppm
(0/0, 1.84, 3.68, 7.32/8.92, 36.5/44.1, and 219 mg/kg/day [M/
F] |
NOAEL is
200 ppm (equivalent to 7.32/8.92mg/ kg/day in males/females)
LOAEL is 1,000 ppm (equivalent to 36.5/44.1mg/ kg/day in males/females)
based on decreased body weights and body
weight gains,and increased incidences of keratitis
in males and striated muscle fiber
atrophy in females. At the high dose there was an incidence
(12%)of nasolacrimal duct squamous cell
carcinomas slightly outside the historical control range
(0-10%) in male rats. A correlation between the incidence of
inflammation and the fluctuating incidence of nasal tumors was
made across dose groups. EPA did not consider the nasolacrimal
duct tumors to be treatment-related. Female rats had a significant
increasing trend in nasolacrimal duct squamous cell carcinomas
at < 0.05, and at the high dose was slightly above
the historical control mean
(0.8%) and range (0-4%). EPA considered the nasolacrimal duct
squamous cell carcinomas to be possibly treatment related, but
that a clear association with treatment could not be made |
870.5100
|
Bacterial
reverse mutation |
61.7
to 5,000 [mu]g/ plate +/-S9 |
Negative |
870.5100
|
Bacterial
system, mammalian activation gene mutation |
33
to 5,000 [mu]g/ plate +/- S9 |
Negative
for metabolite TFNA |
870.5100 |
Bacterial
system, mammalian activation gene mutation |
33
to 5,000 ug/plate +/ - S9 |
Negative
for metabolite TFNA-AM |
870.5100 |
Bacterial
system, mammalian activation gene mutation |
33
to 5,000 ug/plate +/- S9 |
Negative
for metabolite TFNG-AM |
870.5100 |
Bacterial
system, mammalian activation gene mutation |
33
to 5,000 [mu]g/ plate +/- S9 |
Negative
for metabolite TFNA-OH |
870.5100 |
Bacterial
system, mammalian activation gene mutation |
5
to 5000 ug/plate +/- S9 |
Negative
for metabolite TFNG |
870.5300
|
In
vitro mammalian cell gene mutation |
28.3
to 2,290 [mu]g/mL initial test, and 143 to 2,290[mu]g/mL repeat |
Negative |
870.5375
|
In
vitro Cytogenetics |
573,
1145 and 2290 [mu]g/mL |
Negative |
870.5395
|
In
vivo cytogenetic(micronucleus) test in mice |
Twice
orally by intragastric gavage at doses of 250, 500 and 1,000
mg/kg/day for males and 125, 250 and 500 mg/kg/day for females |
Negative |
Non-guideline |
Other
genotoxicity, in vivo Comet assay |
Single
doses of 375, 750 and 1,500 mg/kg |
Was not
positive for nuclear migration up to 1,500 mg/kg |
Non-guideline |
Unscheduled
DNA synthesis |
Once
orally at 600 and 2,000 mg/kg |
Is not
genotoxic in hepatocytes from treated rats |
870.6200 |
Acute
neurotoxicity screening battery (rats) |
0,
100, 300, 600 (males), or 1,000 mg/ kg/day |
NOAEL is
600 mg/kg in males and 300 mg/kg in females
LOAEL is 1,000 mg/kg based on mortality and signs of toxicity
(decreased motor activity, tremors, impaired respiration, and
impaired gait) in males
This acute neurotoxicity study is unacceptable
because interval motor activity data were not provided as specified
according to guidelines,FOB handling and open-field observations
were incomplete, and positive data providedwere from a lab other
than the performing lab for this study. This
study is not required for this risk assessment and additional
information is not required |
870.6200
|
Subchronic
neurotoxicity screening battery (rats) |
0,
200, 1000, or 10,000 ppm (0/0, 13/ 16, 67/81, or 625/722 mg/kg/day
[M/F] |
NOAEL is
200/1,000 ppm (equivalent to 13/81mg/kg/day [M/F]
LOAEL is 1,000/10,000 ppm (equivalent to 67/722 mg/kg/day [M/F]
based on decreased motor activity, rearing,
and foot splay in males, decreased body weights, body
weight gains, and food consumption in males and females |
870.7485 |
Metabolism
and pharmacokinetics (rats) |
Pilot
excretion study, single oral dose 0.85 or 21 mg/kg and pilot
pharmacokinetic study, single oral dose of 2 or 50 mg/kg |
IKI-220
(flonicamid) was rapidly absorbed and excreted with no apparent
differences between the sexes. By 48 hours after treatment,
93% of the administered dose had been eliminated and by 168
hours ~96% was eliminated. The primary route of elimination
was the urine, accounting for ~90% of the dose. The feces of
treated rats accounted for ~5% of the administered dose, with
no significant amounts of radiolabel detected in expired air
of either sex. After 168 hours of a single high or low dose
of the test material, < 3% of the radioactivity was recovered
in the carcass and < 0.05% in the blood, irrespective of
dose or sex
The pharmacokinetic parameters were also similar between the
dose levels (2 and 50mg/kg) and sexes. The radiolabel was rapidly
absorbed and excreted. The apparent plasma half-life (T[frac1s2])
was 4.8-6.0 hours and the elimination followed first order kinetics.
The time of maximum plasma concentration(Tmax) for individual
animals ranged from 0.25 to 1 hour after treatment (with a mean
for each group of 0.3-0.6 hours) |
870.7485 |
Metabolism
and pharmacokinetics (rats) |
2
or 400 mg/kg |
Appears
that the overall pharmacokinetics recovery of radioactive (rats)
dose from all group was 94-99% by 168 hours post-dose.
Absorption was rapid and extensive, detected in plasma within
10 minutes of dosing, with maximum plasma concentrations within
24-54 minutes. By
168 hours post-dose, total urinary excretion was 72-78%, cage
rinse was 10-21%, and fecal excretion was 4-7% dose. Parent
(IKI-220) (flonicamid) and 9 metabolites accounted for 80-94%
of the dose for all groups. Parent was detected primarily in
the urine, 46-73% of the dose in excreta in all groups. The
primary metabolite was 4-trifluoromethylnicotinamid e(TFNA-AM),
18-27% dose in all dose groups, along with minor amounts of
TFNA-AM N- oxide (1-4% dose). Other metabolites in urine and
feces were detected at less than or equal to 2.5% of the dose.IKI-220
(flonicamid) was excreted primarily unchanged in the urine,
but biotransformation of IKI- 220 (flonicamid) in rats included
nitrile hydrolysis,N-oxidation, hydroxylation of the pyridine
ring and amidehydrolysis |
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, the dose at which no adverse effects are observed
(the NOAEL) from the toxicology study identified as appropriate
for use
in risk assessment is used to estimate the toxicological 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 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 (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 safety 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
exposure (margin of exposure (MOE) = NOAEL/exposure) is calculated
and
compared to the LOC.
A summary of the toxicological dose and endpoints for flonicamid
used for human risk assessment is shown in Table 2 of this unit:
Table
2.--Toxicological Doses and Endpoints for Flonicamid Human Health
Risk Assessments |
Exposure
Scenario |
Dose Used
in Risk Assessment, UF |
Special
FQPA SF* and
Level of Concern for Risk Assessment |
Study and
Toxicological Effects |
Acute dietary |
None |
FQPA SF
= NA
aPAD = NA............. |
Quantitative
risk assessment is not required since there are no acute dietary
toxicity concerns |
Chronic
dietary |
NOAEL =
3.7 mg/kg/day
UF = 100..............
Chronic RfD = 0.04mg/ kg/day. |
FQPA SF
= 1
aPAD = chronic RfD/
FQPA SF= 0.04 mg/kg/ day. |
2-Generation
Reproduction rat
Parental
LOAEL = 22 mg/kg/day based on increased kidney
weights, kidney hyaline deposition,
increased blood serum LH (F1 females)
|
Cancer
|
Suggestive
evidence of carcinogenic potential |
UF
= uncertainty factor, FQPA SF = Special FQPA safety factor,
NOAEL = no observed adverse effect level, LOAEL = lowest observed
adverse effect level, PAD = population adjusted dose (a = acute,
c = chronic) RfD = reference dose, MOE = margin of exposure,
LOC = level of concern, NA = Not Applicable |
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances are being
proposed for the combined residues of flonicamid and its metabolites,
in or on a variety of raw agricultural commodities. Risk assessments
were conducted by EPA to assess dietary exposures from flonicamid
and
its metabolites in food as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. No such effects were
identified in the toxicological studies for flonicamid; therefore,
a
quantitative acute dietary exposure assessment is unnecessary.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the Dietary Exposure Evaluation Model software
with
the Food Commodity Intake Database (DEEM-FCID\TM\ Version 2), which
incorporates food consumption data as reported by respondents in
the
USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake
by
Individuals (CSFII), and accumulated exposure to the chemical for
each
commodity. The following assumptions were made for the chronic exposure
assessments: 100% crop treated, tolerance level residues, and drinking
water estimated concentration of 0.94 parts per billion (ppb).
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive
dietary
exposure analysis and risk assessment for flonicamid and its
metabolites in drinking water. Because the Agency does not have
comprehensive monitoring data, drinking water concentration estimates
are made by reliance on simulation or modeling taking into account
data
on the physical characteristics of flonicamid and its metabolites.
The Agency uses the Generic Estimated Environmental Concentration
(GENEEC) or the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) to estimate pesticide concentrations in surface
water and Screening Concentrations in Groundwater (SCI-GROW), which
predicts pesticide concentrations in ground water. In general, EPA
will
use GENEEC (a Tier 1 model) before using PRZM/EXAMS to estimate
pesticide concentrations (a Tier 2 model) for a screening-level
assessment for surface water. The GENEEC model is a subset of the
PRZM/
EXAMS model that uses a specific high-end runoff scenario for
pesticides. GENEEC incorporates a farm pond scenario, while PRZM/EXAMS
incorporate an index reservoir environment in place of the previous
pond scenario. The PRZM/EXAMS model includes a percent crop area
factor
as an adjustment to account for the maximum percent crop coverage
within a watershed or drainage basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from
the
source water. The primary use of these models by the Agency at this
stage is to provide a screen for sorting out pesticides for which
it is
unlikely that drinking water concentrations would exceed human health
levels of concern.
In order to fully implement the requirements of FQPA, EPA
determined that chronic estimated drinking water concentrations
(EDWCs)
can be used directly in chronic dietary exposure assessments to
calculate aggregate dietary (food + water) risk. This is done by
using
the relevant PRZM-EXAMS value as a residue for water (all sources)
in
the dietary exposure assessment. The principal advantage of this
approach is that the actual individual body weight and water
consumption data from the CSFII are used, rather than assumed weights
and consumption for broad age groups. This refinement has been used
for
the flonicamid chronic aggregate risk assessment for surface water.
Based on the PRZM/EXAMS and SCI-GROW models, the EDWCs of combined
residues of flonicamid and its metabolites for chronic exposures
are
estimated to be 0.94 ppb for surface water and 0.00137 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).
Flonicamid is not registered for use on any sites that would result
in residential exposure.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance,
the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
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 flonicamid and any
other
substances, and flonicamid does not appear to produce a toxic
metabolite produced by other substances. EPA considered that there
might be a common mechanism among flonicamid and other pesticides.
EPA
concluded that the evidence did not support a finding of common
mechanism for flonicamid and other pesticides. For the purposes
of this
tolerance action, therefore, EPA has not assumed that flonicamid
has a
common mechanism of toxicity with other
[[Page 51612]]
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 Office of Pesticide Programs concerning common
mechanism determinations and procedures for cumulating effects from
substances found to have a common mechanism on EPA's website 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. There was no evidence for
quantitative or qualitative susceptibility following oral or dermal
exposures to rats in utero or oral exposure to rabbits in utero.
Following oral exposures to rats, developmental effects were seen
only
in the presence of maternal toxicity. No developmental effects were
seen in rabbits.
The degree of concern for prenatal and/or postnatal susceptibility
is low due to the lack of evidence of qualitative and quantitative
susceptibility. This is because developmental effects were only
seen in
one species, only at the maternal toxicity dose, and effects seen
in
offspring were not more severe than those seen in the maternal
toxicity. Thus, neither qualitative nor quantitative susceptibility
issues are of concern for flonicamid. The database for required
developmental and reproductive studies is complete, thus there are
no
residual uncertainties.
3. Conclusion. The FQPA Safety Factor is
reduced to 1X because:
i. There is a complete toxicity database;
ii. There is a lack of susceptibility evidence in the developmental
studies and reproductive study (The effects seen in offspring were
mild
and occurred only in one species.);
iii. The dietary food exposure assessment utilizes proposed
tolerance level or higher residues and 100% CT information for all
commodities; and
iv. The dietary drinking water assessment (Tier 1 estimates)
utilizes values generated by model and associated modeling parameters
which are designed to provide conservative, health protective, high-end
estimates of water concentrations.
E. Aggregate Risks and Determination of Safety
1. Acute risk. No acute risk is expected for the following reasons:
No acute toxicity endpoint was identified. There was no endpoint
noted
in the database from a single dose exposure that could be used for
risk
assessment. This included the acute neurotoxicity and developmental
toxicity studies as well as other short- and long-term studies.
Body
weight decreases were consider inappropriate for this acute endpoint
since in these studies they occur later then the acute time interval.
The observed vomiting in either the acute or subchronic dog studies
occurred without manifestations of any other acute clinical signs
or
related pathology. Thus acute clinical effects seen in the dog studies
were considered not appropriate. The acute neurotoxicity study was
also
not appropriate for the general population since the effects observed
only occurred in the high doses tested where mortality was also
observed, and therefore the neurotoxicity signs were probably part
of
the death response. While death can be an acute response, the dose
at
which death occurred was in EPA's judgement, so high that it is
unlikely to happen. In addition, the acute neurotoxicity study did
not
have all the required observations. The effects observed in the
developmental studies were not attributable to an acute response,
and
therefore the developmental studies were not used for an acute endpoint
for females of reproductive age. Thus, an acute dietary endpoint
was
not considered appropriate.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
flonicamid and its metabolites from food and drinking water will
utilize 11% of the cPAD for the U.S. population, 15% of the cPAD
for
all infants < 1 year old, and 25% of the cPAD for children 1-2
years
old. There are no residential uses for flonicamid that result in
chronic residential exposure to flonicamid.
3. Short-term and intermediate term risk. Short-term aggregate
exposure takes into account residential exposure plus chronic exposure
to food and water (considered to be a background exposure level).
Intermediate-term aggregate exposure takes into account residential
exposure plus chronic exposure to food and water (considered to
be a
background exposure level). Flonicamid is not registered for use
on any
sites that would result in residential exposure. Therefore, the
aggregate risk is the sum of the risk from food and water, which
do not
exceed the Agency's level of concern.
4. Aggregate cancer risk for U.S. population.
In assessing the
carcinogenic potential of flonicamid, EPA took into account the
following weight-of-the-evidence considerations:
i. Flonicamid is not mutagenic.
ii. The treatment-related CD-1 mouse lung
tumors (benign and
malignant) which occurred in both sexes were due to an established
mitogenic mode of action that occurred in a susceptible mouse strain
with a high background. A clear species difference was observed
between
mice and rats in the incidence of lung tumors and the BrdU Index
studies. (Bromodeoxyuridine (BrdU) Index studies are used to quantify
rates of cell proliferation). No tumors were seen in the lungs of
rats.
The flonicamid induced increase in the BrdU Index appears to be
related
to the different sensitivity of strains of mice, with the CD-1 mice
being a relatively sensitive strain.
iii. The only other tumor response was nasolacrimal duct tumors
which occurred in female rats at the high dose which were considered
to
be possibly treatment-related, but a clear association with treatment
could not be made.
Unlike male rats, the nasal tumor response in females could not
be
clearly associated with spontaneous inflammation related to
malocclusion of incisor teeth, due
to the low incidence of both the
neoplastic and non-neoplastic lesions. Given these findings in the
cancer and mutagenicity studies, EPA regards the carcinogenic potential
of flonicamid as very low and concludes that it poses no greater
than a
negligible cancer risk to humans.
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, and to infants and children from aggregate
exposure to flonicamid residues.
[[Page 51613]]
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methods are available to enforce the proposed
tolerances of flonicamid and the major metabolites in plants and
livestock. The proposed method for plants uses a LC/MS/MS (FMC No.
P-
3561M) to determine the residues of flonicamid and its major
metabolites, TFNA-AM (4-trifluoromethylnicotinamide), TFNA (4-
trifluoromethylnicotinic acid), and TFNG [N-(4-
trifluoromethylnicotinoyl)glycine]. The reported LOQ was 0.01 ppm
and
the reported LOD was 0.005 ppm for peach, potato, processed commodities
of apples, plums, potatoes, and tomatoes. The reported LOQ was 0.02
ppm
and the LOD was 0.01 ppm for each analyte in/on wheat; cotton seed,
hulls, and refined oil. The method was adequately validated by an
independent laboratory.
For livestock, three methods were proposed: LC/MS/MS method (RCC
No. 844743) for residues in eggs and livestock tissues, LC/MS method
(RCC No. 842993) for residues in milk, and LC/MS/MS method (FMC
P3580)
which include an acid hydrolysis step for residues in cattle muscle,
kidney and liver. The three livestock methods recommend the use
of
calibration standards, prepared by using control matrix extracts
for
all or some of the analyze/matrix combinations to remove matrix
enhancement effects. The methods were adequately validated by an
independent laboratory. These methods may be used for the determination
of residues of flonicamid and its metabolites TFNA-AM, TFNG, and
TFNA.
The validated LOQ was 0.01 ppm and LOD was 0.005 ppm for methods
844743
and 842993; the reported validated LOQ was 0.025 ppm and the LOD
was
0.005 ppm for method FMC P3580.
Enforcement methodology 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
No Codex, Mexican or Canadian MRLs or tolerances have been established.
Therefore no compatibility questions exist with respect to Codex.
C. Response to Comments
EPA received one comment from the National
Cotton Council, which
stated that it supports ISK Bioscience's request for the establishment
of tolerances in the listed food and feed items. In today's
action, EPA
is responding affirmatively to this comment.
V. Conclusion
Therefore, tolerances are established for the combined residues
of
flonicamid [N-(cyanomethyl)-4-trifluoromethyl)-3-pyridinecarboxamide],
and its metabolites TFNA [4-trifluoromethylnicotinic acid], TFNA-AM
[4-
trifluoromethylnicotinamide] and TFNG [N-(4-
trifluoromethylnicotinoyl)glycine] in or on the crops at tolerance
levels listed in Unit III.
Tolerances are established for the combined residues of flonicamid
[N-(cyanomethyl)-4-(trifluoromethyl)-3-pyridinecarboxamide], and
its
metabolites TFNA [4-trifluoromethylnicotinic acid] and TFNA-AM [4-
trifluoromethylnicotinamide] in or on the livestock commodities
at
tolerance levels listed in Unit III.
VI. 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-2005-0217 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 October
31, 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 issue(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 VI.A.,
you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in ADDRESSES. Mail your
copies, identified by docket ID number OPP-2005-0217, to: Public
Information and Records Integrity Branch, Information Resources
and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the
PIRIB described in ADDRESSES. You may also send an electronic copy
of
your request via e-mail to: opp-docket@epa.gov. Please use an ASCII
file format and avoid the use of special characters and any form
of
encryption. Copies of electronic objections and hearing requests
will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit
an
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 51614]]
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).
VII. Statutory and Executive Order Reviews
This final rule establishes a tolerance 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.
VIII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by
the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the
rule,
to each House of the Congress and to the Comptroller General of
the
United States. EPA will submit a report containing this rule and
other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States
prior
to publication of this final rule in the Federal Register. This
final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: August 19, 2005.
Lois A. Rossi,
Acting Director, 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. Section 180.613 is added to read as follows:
Sec. 180.613 Flonicamid; tolerances for residues.
(a) General. (1) Tolerances are established for the combined
residues of flonicamid [N-(cyanomethyl)-4-(trifluoromethyl)-3-
pyridinecarboxamide]
and its metabolites TFNA [4-
trifluoromethylnicotinic acid], TFNA-AM [4-trifluoromethylnicotinamide]
TFNG [N-(4-trifluoromethylnicotinoyl)glycine]
in or on the following
raw agricultural commodities:
Commodity
|
Parts
per million |
Cotton,
gin byproducts |
6.0 |
Cotton,
hulls |
2.0 |
Cotton,
meal |
1.0 |
Cotton,
undelinted seed |
0.50 |
Fruit,
pome, group 11 |
0.20 |
Fruit,
stone, group 12 |
0.60 |
Potato |
0.20 |
Potato,
granular/flakes |
0.40 |
Spinach
|
9.0 |
Tomato,
paste |
2.0 |
Tomato,
puree |
0.50 |
Vegetable,
cucurbit, group |
0.40 |
Vegetable,
fruiting, group\ |
0.40 |
Vegetable,
leafy except Brassica group 4,
except spinach |
4.0 |
(2) Tolerances are established for combined residues of flonicamid
[N-(cyanomethyl)-4-(trifluoromethyl)-3-pyridinecarboxamide], and
its
metabolites TFNA [4-trifluoromethylnicotinic acid], TFNA-AM [4-
trifluoromethylnicotinamide]
in or on the following raw agricultural
commodities:
Commodity
|
Parts
per million |
Cattle,
fat |
0.02 |
Cattle,
meat |
0.05 |
Cattle,
meat byproducts |
0.08 |
Egg |
0.03 |
Goat, fat |
0.02 |
Goat, meat |
0.05 |
Goat, meat
byproducts |
0.08 |
Horse,
fat |
0.02 |
Horse,
meat |
0.05 |
Horse,
meat byproducts |
0.08 |
Milk |
0.02 |
Poultry,
fat |
0.02 |
Poultry,
meat byproducts |
0.02 |
Sheep,
fat |
0.02 |
Sheep,
meat |
0.05 |
Sheep,
meat by products |
0.08 |
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 05-17128 Filed 8-30-05; 8:45 am]
BILLING CODE 6560-50-S
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