Flonicamid - CAS No. 158062-67-0
Pesticide tolerances. Final Rule.
August 31, 2005. Federal Register.
Docket OPP-2005-0217
 
 

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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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