Flutolanil; Pesticide Tolerances, 17566-17571 [2010-7624]
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the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply
to this final rule. In addition, this final
rule does not impose any enforceable
duty or contain any unfunded mandate
as described under Title II of the
Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104–4).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note).
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IV. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report to each House of
the Congress and to the Comptroller
General of the United States. EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of this final rule in the
Federal Register. This final rule is not
a ‘‘major rule’’ as defined by 5 U.S.C.
804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
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Dated: March 26, 2010.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
■
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
§ 180.628
[Amended]
2. In § 180.628, amend the table in
paragraph (d) by revising the expiration/
revocation dates ‘‘4/10/10’’ to read ‘‘4/
10/14,’’ each time it appears.
■
[FR Doc. 2010–7744 Filed 4–6–10; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2009–0553; FRL–8817–9]
Flutolanil; Pesticide Tolerances
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes
tolerances for residues of flutolanil in or
on cotton and soybean. Nichino
America, Inc. requested these tolerances
under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective April
7, 2010. Objections and requests for
hearings must be received on or before
June 7, 2010, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2009–0553. All documents in the
docket are listed in the docket index
available at https://www.regulations.gov.
Although listed in the index, some
information is not publicly available,
e.g., Confidential Business Information
(CBI) or other information whose
disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available in the electronic docket at
https://www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S–
ADDRESSES:
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4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The
Docket Facility is open from 8:30 a.m.
to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket
Facility telephone number is (703) 305–
5805.
FOR FURTHER INFORMATION CONTACT: Lisa
Jones, Registration Division, Office of
Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460–
0001; telephone number: (703) 308–
9424; e-mail address:
jones.lisa@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to those engaged in the
following activities:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
This listing is not intended to be
exhaustive, but rather to provide a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Get Electronic Access to
Other Related Information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
cite at https://www.gpoaccess.gov/ecfr.
To access the OPPTS harmonized test
guidelines referenced in this document
electronically, please go https://
www.epa.gov/oppts and select ‘‘Test
Methods and Guidelines.’’
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of FFDCA, 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
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objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2009–0553 in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing, and must be
received by the Hearing Clerk on or
before June 7, 2010. Addresses for mail
and hand delivery of objections and
hearing requests are provided in 40 CFR
178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing that does not
contain any CBI for inclusion in the
public docket that is described in
ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit this copy,
identified by docket ID number EPA–
HQ–OPP–2009–0553, by one of the
following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries
are only accepted during the Docket
Facility’s normal hours of operation
(8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays).
Special arrangements should be made
for deliveries of boxed information. The
Docket Facility telephone number is
(703) 305–5805.
II. Petition for Tolerance
In the Federal Register of September
4, 2009 (74 FR 45848) (FRL–8434–4),
EPA issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition (PP 9F7542) by
Nichino America, Inc., 4550 New
Linden Hill Rd., Suite 501, Wilmington,
DE 19808. The petition requested that
40 CFR 180.484 be amended by
establishing tolerances for residues of
the fungicide flutolanil, (N-(3-(1methylethoxy) phenyl) -2(trifluoromethyl) benzamide) and its
metabolite, M-4, desisopropylflutolanil
(N-(3-hydroxyphenyl)-2-(trifluromethyl)
benzamide), expressed as 2trifluoromethyl benzoic acid and
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calculated as flutolanil, in or on cotton
at 0.05 parts per million (ppm) and in
or on soybean at 0.05 ppm. That notice
referenced a summary of the petition
prepared by Nichino America, Inc., the
registrant, which is available to the
public in the docket, https://
www.regulations.gov. Comments were
received on the notice of filing. EPA’s
response to these comments is
discussed in Unit IV.C.
EPA has modified the proposed
tolerance expression to: ‘‘residues of
flutolanil, (N-(3-(1-methylethoxy)
phenyl)-2-(trifluoromethyl) benzamide),
including its metabolites and
degradates, in or on the commodities in
the table below. Compliance with the
tolerance levels specified below is to be
determined by measuring only flutolanil
and its metabolites converted to 2(trifluoromethyl) benzamide and
calculated as flutolanil.’’ Based on
review of the data supporting the
petition, EPA has also modified the
proposed tolerances to be established
under paragraph (a), General, for
flutolanil at 40 CFR 180.484 as follows:
Soybean, seed, 0.20 ppm; soybean,
forage, 8.0 ppm; soybean, hay, 2.5 ppm;
cotton, undelinted seed, 0.20 ppm and
cotton, gin byproducts, 0.20 ppm.
Additionally, the following tolerances
will be removed from paragraph (d),
Indirect or inadvertent residues, for
flutolanil as redundant: Soybean, seed
0.20 ppm; soybean, forage, 8.0 ppm and
soybean hay, 2.5 ppm. The reasons for
these changes are explained in Unit
IV.D.
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Consistent with section 408(b)(2)(D)
of FFDCA, and the factors specified in
section 408(b)(2)(D) of FFDCA, EPA has
reviewed the available scientific data
and other relevant information in
support of this action. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure for flutolanil
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with flutolanil follows.
III. Aggregate Risk Assessment and
Determination of Safety
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 adverse
effects caused by flutolanil as well as
the no-observed-adverse-effect-level
(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies are discussed in the
final rule published in the Federal
Register of June 11, 2008, (73 FR 33013)
(FRL–8365–6). The complete
toxicological profile for flutolanil can be
found at https://www.regulations.gov on
pages 7 through 12 in the document
‘‘Flutolanil, Human Health Risk
Assessment: Requests for Inadvertent or
Indirect Tolerances for Use on Soybean,
Wheat, Corn and Cotton’’ in docket ID
number EPA–HQ–OPP–2007–1021.
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. . . . ’’
B. Toxicological Points of Departure/
Levels of Concern
Once a pesticide’s toxicological
profile is determined, EPA identifies
toxicological points of departure (POD)
and levels of concern to use in
evaluating the risk posed by human
exposure to the pesticide. For hazards
that have a threshold below which there
is no appreciable risk, the toxicological
POD is used as the basis for derivation
of reference values for risk assessment.
PODs are developed based on a careful
analysis of the doses in each
toxicological study to determine the
dose at which no adverse effects are
observed (the NOAEL) and the lowest
dose at which adverse effects of concern
are identified (the LOAEL). Uncertainty/
safety factors are used in conjunction
with the POD to calculate a safe
exposure level-generally referred to as a
population-adjusted dose (PAD) or a
reference dose (RfD) and a safe margin
of exposure (MOE). For non-threshold
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risks, the Agency assumes that any
amount of exposure will lead to some
degree of risk. Thus, the Agency
estimates risk in terms of the probability
of an occurrence of the adverse effect
expected in a lifetime. For more
information on the general principles
EPA uses in risk characterization and a
complete description of the risk
assessment process, see https://
www.epa.gov/pesticides/factsheets/
riskassess.htm.
A summary of the toxicological
endpoints for flutolanil used for human
risk assessment is discussed in Unit III,
Aggregate Risk Assessment and
Determination of Safety, of the final rule
published in the Federal Register of
June 11, 2008 (73 FR 33013) (FRL–
8365–6).
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to flutolanil, EPA considered
exposure under the petitioned-for
tolerances as well as all existing
flutolanil tolerances in 40 CFR 180.484.
EPA assessed dietary exposures from
flutolanil 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 flutolanil;
therefore, a quantitative acute dietary
exposure assessment is unnecessary.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the food consumption data
from the U.S. Department of Agriculture
(USDA) 1994–1996 and 1998
Continuing Survey of Food Intake by
Individuals (CSFII). As to residue levels
in food, the chronic dietary analysis
included tolerance level residues, 100
percent crop treated estimates and
processing factors (default).
iii. Cancer. EPA determines whether
quantitative cancer exposure and risk
assessments are appropriate for a fooduse pesticide based on the weight-ofthe-evidence from cancer studies and
other relevant data. Cancer risk is
quantified using a linear or nonlinear
approach. If sufficient information on
the carcinogenic mode of action is
available, a threshold or non-linear
approach is used and a cancer RfD is
calculated based on an earlier
noncancer key event. If carcinogenic
mode of action data are not available, or
if the mode of action data determines a
mutagenic mode of action, a default
linear cancer slope factor approach is
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utilized. Based on the lack of evidence
of carcinogenicity in two rodent studies
and the lack of evidence of
mutagenicity, flutolanil is not expected
to pose a cancer risk to humans.
Therefore, a dietary exposure
assessment for the purpose of assessing
cancer risk is unnecessary.
iv. Anticipated residue and percent
crop treaded (PCT) information. EPA
did not use anticipated residue and/or
PCT information in the dietary
assessment for flutolanil. Tolerance
level residues and/or 100% CT were
assumed for all food commodities.
2. Dietary exposure from drinking
water. The Agency used screening level
water exposure models in the dietary
exposure analysis and risk assessment
for flutolanil in drinking water. These
simulation models take into account
data on the physical, chemical, and fate/
transport characteristics of flutolanil.
Further information regarding EPA
drinking water models used in pesticide
exposure assessment can be found at
https://www.epa.gov/oppefed1/models/
water/index.htm.
The Agency used the First
Approximation Rice Model (FARM) to
estimate pesticide concentrations in
surface water after applying flutolanil
on rice and Screening Concentrations in
Ground Water (SCI-GROW), which
predicts pesticide concentrations in
ground water. In general, EPA will use
Generic Expected Environmental
Concentrations (GENEEC) (a Tier 1
model) before using Pesticide Root
Zone/Exposure Analysis Modeling
System (PRZM/EXAMS) (a Tier 2
model) for a screening-level assessment
for surface water, but given the unique
hydrological issues arising from
pesticide application to rice paddies,
EPA used the FARM rather than
GENEEC or PRZM/EXAMS for surface
water estimates.
Based on the SCI-GROW model, and
the FARM (to estimate pesticide
concentrations in surface water after
applying flutolanil on rice) the
estimated environmental concentrations
(EECs) of flutolanil for acute exposures
are estimated to be 3.8 parts per billion
(ppb) for surface water and 0.34 ppb for
ground water. The EEC for peak acute
exposure is estimated to be 11.6 ppb for
surface water. The EECs for chronic
exposures are estimated to be 3.8 ppb
for surface water and 0.34 ppb for
ground water.
For chronic dietary risk assessment,
the water concentration of value 3.8 ppb
was used to assess the contribution to
drinking water.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to non-
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occupational, non-dietary exposure
(e.g., for lawn and garden pest control,
indoor pest control, termiticides, and
flea and tick control on pets).
Flutolanil is currently registered for
the following uses that could result in
residential exposures: Turf grass and
ornamental plants. EPA assessed
residential exposure using the following
assumptions: Although residential (nonoccupational) exposure exists, a
quantitative exposure assessment was
not conducted since no toxicological
endpoint attributable to acute, shortterm or intermediate-term exposure
have been identified and the current use
pattern does not indicate chronic or
long-term exposure (6 or more months
of continuous exposure) potential.
Further information regarding EPA
standard assumptions and generic
inputs for residential exposures may be
found at https://www.epa.gov/pesticides/
trac/science/trac6a05.pdf.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance, the Agency consider
‘‘available information’’ concerning the
cumulative effects of a particular
pesticide’s residues and ‘‘other
substances that have a common
mechanism of toxicity.’’
EPA has not found flutolanil to share
a common mechanism of toxicity with
any other substances, and flutolanil
does not appear to produce a toxic
metabolite produced by other
substances. For the purposes of this
tolerance action, therefore, EPA has
assumed that flutolanil does not have a
common mechanism of toxicity with
other substances. For information
regarding EPA’s efforts to determine
which chemicals have a common
mechanism of toxicity and to evaluate
the cumulative effects of such
chemicals, see EPA’s website at https://
www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and
Children
1. In general. Section 408(b)(2)(C) of
FFDCA provides that EPA shall apply
an additional tenfold (10X) margin of
safety for infants and children in the
case of threshold effects to account for
prenatal and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
FQPA Safety Factor (SF). In applying
this provision, EPA either retains the
default value of 10X, or uses a different
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additional safety factor when reliable
data available to EPA support the choice
of a different factor.
2. Prenatal and postnatal sensitivity.
There was no evidence of increased
susceptibility of rat or rabbit fetuses to
in utero exposure or rat pups to postnatal exposure to flutolanil. Flutolanil is
not a developmental or reproductive
toxicant. No maternal, reproductive, or
developmental toxicity was observed at
the limit dose.
3. Conclusion. EPA has determined
that reliable data show the safety of
infants and children would be
adequately protected if the FQPA SF
were reduced to 1X. That decision is
based on the following findings:
i. The toxicity database for flutolanil
is complete except for acute and
subchronic neurotoxicity and
immunotoxicity studies. Recent changes
to 40 CFR part 158 make acute and
subchronic neurotoxicity testing
(OPPTS Test Guideline 870.6200), and
immunotoxicity testing (OPPTS Test
Guideline 870.7800) required for
pesticide registration. However, the
available data for flutolanil do not
suggest that the compound produces
hematological or thymus/spleen organ
effects indicative of immunotoxicity.
Further, there is no evidence of
neurotoxicity in any study in the
toxicity database for flutolanil.
Therefore, EPA does not believe that
conducting neurotoxicity and
immunotoxicity studies will result in a
NOAEL lower than the NOAEL of 50
milligrams/kilogram/day (mg/kg/day)
already established for flutolanil.
Consequently, an additional database
uncertainty factor does not need to be
applied.
ii. There is no indication that
flutolanil is a neurotoxic chemical and
there is no need for a developmental
neurotoxicity study or additional UFs to
account for neurotoxicity.
iii. There is no evidence that
flutolanil results in increased
susceptibility in in utero rats or rabbits
in the prenatal developmental studies or
in young rats in the 2–generation
reproduction study.
iv. There are no residual uncertainties
identified in the exposure databases.
The dietary food exposure assessments
were performed based on 100% CT and
tolerance-level residues. EPA made
conservative (protective) assumptions in
the ground water and surface water
modeling used to assess exposure to
flutolanil in drinking water. Residential
exposure does not pose a concern for
flutolanil because (1) chronic residential
exposure is not expected; and (2)
although short-term or intermediateterm residential exposure may occur, no
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relevant adverse effects were identified
for dermal or incidental oral or
inhalation exposure related to
residential use. These assessments will
not underestimate the exposure and
risks posed by flutolanil.
E. Aggregate Risks and Determination of
Safety
EPA determines whether acute and
chronic dietary pesticide exposures are
safe by comparing aggregate exposure
estimates to the acute population
adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). For
linear cancer risks, EPA calculates the
lifetime probability of acquiring cancer
given the estimated aggregate exposure.
Short-term, intermediate-term, and
chronic-term risks are evaluated by
comparing the estimated aggregate food,
water, and residential exposure to the
appropriate PODs to ensure that an
adequate MOE exists.
1. Acute Risk. An acute aggregate risk
assessment takes into account acute
exposure estimates from dietary
consumption of food and drinking
water. No adverse effect resulting from
a single oral exposure was identified
and no acute dietary endpoint was
selected. Therefore, flutolanil is not
expected to pose an acute risk.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that chronic exposure to flutolanil from
food and water will utilize 2% of the
cPAD for children between 1 to 2 years
old, the population group receiving the
greatest exposure. Based on the
explanation in Unit III.C.3., regarding
residential use patterns, chronic
residential exposure to residues of
flutolanil is not expected.
3. Short-term and intermediate-term
risk. Short-term and intermediate-term
aggregate exposure take into account
short-term and intermediate-term
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level).
Because no short- or intermediateterm adverse effect was identified,
flutolanil is not expected to pose a
short-term or intermediate-term risk.
4. Aggregate cancer risk for U.S.
population. EPA has classified flutolanil
as ‘‘not likely’’ to be a human
carcinogen.
5. Determination of safety. Based on
these risk assessments, EPA concludes
that there is a reasonable certainty that
no harm will result to the general
population, or to infants and children
from aggregate exposure to flutolanil
residues.
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17569
IV. Other Considerations
A. Analytical Enforcement Methodology
An adequate enforcement
methodology, (Method AU/95R/04), a
common moiety Gas Chromatography/
Mass Spectrometry (GC/MS) method
which determines residues of flutolanil
and metabolites as 2-trifluoromethyl
benzoic acid (2-TFBA) is available to
enforce the tolerance expression.
The method may be requested from:
Chief, Analytical Chemistry Branch,
Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755–5350;
telephone number: (410) 305–2905; email address: residuemethods@epa.gov.
B. International Residue Limits
Codex maximum residue limits
(MRLs) are established for residues of
flutolanil in rice commodities at 1–10
ppm, and in livestock commodities at
0.05–0.2 ppm. No Canadian or Mexican
MRLs have been established. No Codex
MRLs are established for soybean,
cotton seed, or sugar beet commodities.
C. Response to Comments
One comment was received from a
private citizen objecting to the
establishment of tolerances for
flutolanil. The commenter criticized
EPA’s reliance on toxicology testing on
animals. The Agency has received, and
responded to, similar comments from
this commenter on numerous previous
occasions. Refer to the Federal Register
issues of June 30, 2005 (70 FR 37686),
January 7, 2005 (70 FR 1354), October
28, 2004 (FR 69 63096) for the Agency’s
response to these objections.
D. Revisions to Petitioned-For
Tolerances
The Agency is establishing tolerances
that are greater than the proposed
tolerance for soybean seed and cotton
seed because the enforcement analytical
method has not been validated at a level
below 0.20 ppm, and the greater
tolerance value is needed to
accommodate indirect residues from
soybean rotational crops. Additional
tolerances are established for cotton gin
byproducts, as the radiolabeled seed
treatment study revealed residues on
cotton gin trash, and soybean hay to
accommodate the seed treatment use
and the inadvertent residue from
soybean as a rotational crop.
EPA is revising the tolerance
expression in §180.484 to clarify that, as
provided in FFDCA section 408(a)(3),
the tolerance covers metabolites and
degradates of flutolanil not specifically
mentioned; and that compliance with
the specified tolerance levels is to be
determined by measuring only the
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specific compounds mentioned in the
tolerance expression. The tolerance
definition previously read ‘‘residues of
the fungicide flutolanil, N-(3-(1methylethoxy)phenyl)-2(trifluoromethyl)benzamide, and its
metabolites converted to 2(trifluoromethyl) benzoic acid and
calculated as flutolanil.’’ It is being
changed to ‘‘residues of flutolanil, N-(3(1-methylethoxy)phenyl)-2(trifluoromethyl)benzamide, including
its metabolites and degradates, in or on
the commodities. Compliance with the
tolerance levels is to be determined by
measuring only flutolanil and its
metabolites converted to 2(trifluoromethyl) benzoic acid and
calculated as flutolanil.’’
Finally, the inadvertent residue,
rotational crop tolerances previously
established for soybean forage and
soybean hay encompass the use on
soybean as a seed treatment. Therefore
the tolerances established under
paragraph (d), Indirect or inadvertent
residues, for soybean, seed at 0.20 ppm;
soybean, forage at 8.0 ppm, and soybean
hay at 2.5 ppm are being revoked since
the same tolerance values are being
established under paragraph (a),
General.
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V. Conclusion
Therefore, tolerances are established
for residues of flutolanil, N-(3-(1methylethoxy)phenyl)-2(trifluoromethyl)benzamide, including
its metabolites and degradates, in or on
cotton, undelinted seed at 0.20 ppm;
soybean, seed at 0.20 ppm; soybean,
forage at 8.0 ppm; soybean, hay at 2.5
ppm; cotton, gin byproducts at 0.20
ppm. Compliance with the tolerance
levels is to be determined by measuring
only flutolanil and its metabolites
converted to 2-(trifluoromethyl) benzoic
acid and calculated as flutolanil.
VI. Statutory and Executive Order
Reviews
This final rule establishes tolerances
under section 408(d) of FFDCA in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled Regulatory
Planning and Review (58 FR 51735,
October 4, 1993). Because this final rule
has been exempted from review under
Executive Order 12866, this final rule is
not subject to Executive Order 13211,
entitled Actions Concerning Regulations
That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001) or Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
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15:15 Apr 06, 2010
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Risks (62 FR 19885, April 23, 1997).
This final rule does not contain any
information collections subject to OMB
approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et
seq., nor does it require any special
considerations under Executive Order
12898, entitled Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under section 408(d) of FFDCA, such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply
to this final rule. In addition, this final
rule does not impose any enforceable
duty or contain any unfunded mandate
as described under Title II of the
Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104–4).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note).
VII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report to each House of
the Congress and to the Comptroller
General of the United States. EPA will
submit a report containing this rule and
other required information to the U.S.
PO 00000
Frm 00016
Fmt 4700
Sfmt 4700
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: March 26, 2010.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Prorgams.
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 180.484 is amended as
follows:
a. Revise the section heading.
b. Revise the introductory text of
paragraph (a).
c. Add alphabetically entries to the
table in paragraph (a) for cotton, gin
byproducts; cotton, undelinted seed;
soybean forage; soybean, hay; and
soybean, seed.
d. Revise paragraph (d).
■
§ 180.484 Flutolanil; tolerances for
residues.
(a) General. Tolerances are
established for residues of flutolanil, N(3-(1-methylethoxy) phenyl)-2(trifluoromethyl)benzamide, including
its metabolites and degradates, in or on
the commodities in the table below.
Compliance with the tolerance levels
specified below is to be determined by
measuring only flutolanil and its
metabolites converted to 2(trifluoromethyl) benzoic acid and
calculated as flutolanil, in or on the
following commodities:
Commodity
*
*
Parts per million
*
Cotton, gin byproducts ...
Cotton, undelinted seed
*
*
*
Soybean, forage .............
Soybean, hay ..................
Soybean, seed ................
*
*
*
0.20
0.20
*
*
8.0
2.5
0.20
*
*
*
*
(d) Indirect or inadvertent residues.
Tolerances are established for the
indirect or inadvertent residues of
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Publicly available docket materials are
available in the electronic docket at
https://www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S–
4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The
Docket Facility is open from 8:30 a.m.
to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket
Facility telephone number is (703) 305–
5805.
FOR FURTHER INFORMATION CONTACT: Jim
Commodity
Parts per million
Tompkins, Registration Division
Wheat, bran ....................
0.20 (7505P), Office of Pesticide Programs,
Wheat, forage .................
2.5 Environmental Protection Agency, 1200
Wheat, grain ...................
0.05 Pennsylvania Ave., NW., Washington,
Wheat, hay .....................
1.2 DC 20460–0001; telephone number:
Wheat, straw ...................
0.20 (703) 305–5697; e-mail address:
tompkins.jim@epa.gov.
*
*
*
*
*
SUPPLEMENTARY INFORMATION:
[FR Doc. 2010–7624 Filed 4–6–10; 8:45 am]
flutolanil, N-(3-(1methylethoxy)phenyl)-2(trifluoromethyl)benzamide, including
its metabolites and degradates, in or on
the commodities in the table below.
Compliance with the tolerance levels
specified below is to be determined by
measuring only flutolanil and its
metabolites converted to 2(trifluoromethyl) benzoic acid and
calculated as flutolanil, in or on the
following commodities.
I. General Information
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2009–0673; FRL–8817–4]
Pendimethalin; Pesticide Tolerances
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation amends the
current tolerance for combined residues
of pendimethalin and its metabolite,
expressed as pendimethalin equivalents,
in or on alfalfa forage. BASF
Corporation requested this tolerance
amendment under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective April
7, 2010. Objections and requests for
hearings must be received on or before
June 7, 2010, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2009– 0673. All documents in the
docket are listed in the docket index
available at https://www.regulations.gov.
Although listed in the index, some
information is not publicly available,
e.g., Confidential Business Information
(CBI) or other information whose
disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
WReier-Aviles on DSKGBLS3C1PROD with RULES
ADDRESSES:
VerDate Nov<24>2008
15:15 Apr 06, 2010
Jkt 220001
A. Does this Action Apply to Me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to those engaged in the
following activities:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
This listing is not intended to be
exhaustive, but rather to provide a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Get Electronic Access to
Other Related Information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
cite at https://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of FFDCA, 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
PO 00000
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Fmt 4700
Sfmt 4700
17571
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2009–0673 in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing, and must be
received by the Hearing Clerk on or
before June 7, 2010. Addresses for mail
and hand delivery of objections and
hearing requests are provided in 40 CFR
178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing that does not
contain any CBI for inclusion in the
public docket that is described in
ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit this copy,
identified by docket ID number EPA–
HQ–OPP–2009–0673, by one of the
following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries
are only accepted during the Docket
Facility’s normal hours of operation
(8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays).
Special arrangements should be made
for deliveries of boxed information. The
Docket Facility telephone number is
(703) 305–5805.
II. Petition for Tolerance
In the Federal Register of January 6,
2010 (75 FR 864) (FRL–8801–5), 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 9F7576) by BASF
Corporation, 26 Davis Drive, Research
Triangle Park, NC 27709. The petition
requested that 40 CFR 180.361 be
amended by increasing the tolerance for
the combined residues of the herbicide
pendimethalin, [N-(1-ethylpropyl)-3,4dimethyl-2,6-dinitrobenzenamine], and
its metabolite 4-[(1-ethylpropyl)amino]2-methyl-3,5-dinitrobenzyl alcohol, in
or on alfalfa, forage from 3.0 parts per
million (ppm) to 3.5 (ppm). That notice
referenced a summary of the petition
E:\FR\FM\07APR1.SGM
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Agencies
[Federal Register Volume 75, Number 66 (Wednesday, April 7, 2010)]
[Rules and Regulations]
[Pages 17566-17571]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-7624]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2009-0553; FRL-8817-9]
Flutolanil; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
flutolanil in or on cotton and soybean. Nichino America, Inc. requested
these tolerances under the Federal Food, Drug, and Cosmetic Act
(FFDCA).
DATES: This regulation is effective April 7, 2010. Objections and
requests for hearings must be received on or before June 7, 2010, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2009-0553. All documents in the
docket are listed in the docket index available at https://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at https://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.
FOR FURTHER INFORMATION CONTACT: Lisa Jones, Registration Division,
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703) 308-9424; e-mail address: jones.lisa@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Get Electronic Access to Other Related Information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR cite at https://www.gpoaccess.gov/ecfr. To
access the OPPTS harmonized test guidelines referenced in this document
electronically, please go https://www.epa.gov/oppts and select ``Test
Methods and Guidelines.''
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file
an objection to any aspect of this regulation and may also request a
hearing on those
[[Page 17567]]
objections. You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in 40 CFR part
178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2009-0553 in the subject line on the first page of
your submission. All objections and requests for a hearing must be in
writing, and must be received by the Hearing Clerk on or before June 7,
2010. Addresses for mail and hand delivery of objections and hearing
requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2009-0553, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
II. Petition for Tolerance
In the Federal Register of September 4, 2009 (74 FR 45848) (FRL-
8434-4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
9F7542) by Nichino America, Inc., 4550 New Linden Hill Rd., Suite 501,
Wilmington, DE 19808. The petition requested that 40 CFR 180.484 be
amended by establishing tolerances for residues of the fungicide
flutolanil, (N-(3-(1-methylethoxy) phenyl) -2-(trifluoromethyl)
benzamide) and its metabolite, M-4, desisopropylflutolanil (N-(3-
hydroxyphenyl)-2-(trifluromethyl) benzamide), expressed as 2-
trifluoromethyl benzoic acid and calculated as flutolanil, in or on
cotton at 0.05 parts per million (ppm) and in or on soybean at 0.05
ppm. That notice referenced a summary of the petition prepared by
Nichino America, Inc., the registrant, which is available to the public
in the docket, https://www.regulations.gov. Comments were received on
the notice of filing. EPA's response to these comments is discussed in
Unit IV.C.
EPA has modified the proposed tolerance expression to: ``residues
of flutolanil, (N-(3-(1-methylethoxy) phenyl)-2-(trifluoromethyl)
benzamide), including its metabolites and degradates, in or on the
commodities in the table below. Compliance with the tolerance levels
specified below is to be determined by measuring only flutolanil and
its metabolites converted to 2-(trifluoromethyl) benzamide and
calculated as flutolanil.'' Based on review of the data supporting the
petition, EPA has also modified the proposed tolerances to be
established under paragraph (a), General, for flutolanil at 40 CFR
180.484 as follows: Soybean, seed, 0.20 ppm; soybean, forage, 8.0 ppm;
soybean, hay, 2.5 ppm; cotton, undelinted seed, 0.20 ppm and cotton,
gin byproducts, 0.20 ppm. Additionally, the following tolerances will
be removed from paragraph (d), Indirect or inadvertent residues, for
flutolanil as redundant: Soybean, seed 0.20 ppm; soybean, forage, 8.0
ppm and soybean hay, 2.5 ppm. The reasons for these changes are
explained in Unit IV.D.
III. Aggregate Risk Assessment and Determination of Safety
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. . .
. ''
Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for flutolanil including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with flutolanil
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
adverse effects caused by flutolanil as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies are discussed in the final rule
published in the Federal Register of June 11, 2008, (73 FR 33013) (FRL-
8365-6). The complete toxicological profile for flutolanil can be found
at https://www.regulations.gov on pages 7 through 12 in the document
``Flutolanil, Human Health Risk Assessment: Requests for Inadvertent or
Indirect Tolerances for Use on Soybean, Wheat, Corn and Cotton'' in
docket ID number EPA-HQ-OPP-2007-1021.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level-generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD) and a safe
margin of exposure (MOE). For non-threshold
[[Page 17568]]
risks, the Agency assumes that any amount of exposure will lead to some
degree of risk. Thus, the Agency estimates risk in terms of the
probability of an occurrence of the adverse effect expected in a
lifetime. For more information on the general principles EPA uses in
risk characterization and a complete description of the risk assessment
process, see https://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for flutolanil used for
human risk assessment is discussed in Unit III, Aggregate Risk
Assessment and Determination of Safety, of the final rule published in
the Federal Register of June 11, 2008 (73 FR 33013) (FRL-8365-6).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to flutolanil, EPA considered exposure under the petitioned-
for tolerances as well as all existing flutolanil tolerances in 40 CFR
180.484. EPA assessed dietary exposures from flutolanil 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
flutolanil; therefore, a quantitative acute dietary exposure assessment
is unnecessary.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the U.S. Department
of Agriculture (USDA) 1994-1996 and 1998 Continuing Survey of Food
Intake by Individuals (CSFII). As to residue levels in food, the
chronic dietary analysis included tolerance level residues, 100 percent
crop treated estimates and processing factors (default).
iii. Cancer. EPA determines whether quantitative cancer exposure
and risk assessments are appropriate for a food-use pesticide based on
the weight-of-the-evidence from cancer studies and other relevant data.
Cancer risk is quantified using a linear or nonlinear approach. If
sufficient information on the carcinogenic mode of action is available,
a threshold or non-linear approach is used and a cancer RfD is
calculated based on an earlier noncancer key event. If carcinogenic
mode of action data are not available, or if the mode of action data
determines a mutagenic mode of action, a default linear cancer slope
factor approach is utilized. Based on the lack of evidence of
carcinogenicity in two rodent studies and the lack of evidence of
mutagenicity, flutolanil is not expected to pose a cancer risk to
humans. Therefore, a dietary exposure assessment for the purpose of
assessing cancer risk is unnecessary.
iv. Anticipated residue and percent crop treaded (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for flutolanil. Tolerance level residues and/or 100%
CT were assumed for all food commodities.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for flutolanil in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of flutolanil. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at https://www.epa.gov/oppefed1/models/water/index.htm.
The Agency used the First Approximation Rice Model (FARM) to
estimate pesticide concentrations in surface water after applying
flutolanil on rice and Screening Concentrations in Ground Water (SCI-
GROW), which predicts pesticide concentrations in ground water. In
general, EPA will use Generic Expected Environmental Concentrations
(GENEEC) (a Tier 1 model) before using Pesticide Root Zone/Exposure
Analysis Modeling System (PRZM/EXAMS) (a Tier 2 model) for a screening-
level assessment for surface water, but given the unique hydrological
issues arising from pesticide application to rice paddies, EPA used the
FARM rather than GENEEC or PRZM/EXAMS for surface water estimates.
Based on the SCI-GROW model, and the FARM (to estimate pesticide
concentrations in surface water after applying flutolanil on rice) the
estimated environmental concentrations (EECs) of flutolanil for acute
exposures are estimated to be 3.8 parts per billion (ppb) for surface
water and 0.34 ppb for ground water. The EEC for peak acute exposure is
estimated to be 11.6 ppb for surface water. The EECs for chronic
exposures are estimated to be 3.8 ppb for surface water and 0.34 ppb
for ground water.
For chronic dietary risk assessment, the water concentration of
value 3.8 ppb was used to assess the contribution to drinking water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Flutolanil is currently registered for the following uses that
could result in residential exposures: Turf grass and ornamental
plants. EPA assessed residential exposure using the following
assumptions: Although residential (non-occupational) exposure exists, a
quantitative exposure assessment was not conducted since no
toxicological endpoint attributable to acute, short-term or
intermediate-term exposure have been identified and the current use
pattern does not indicate chronic or long-term exposure (6 or more
months of continuous exposure) potential. Further information regarding
EPA standard assumptions and generic inputs for residential exposures
may be found at https://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA has not found flutolanil to share a common mechanism of
toxicity with any other substances, and flutolanil does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
flutolanil does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at https://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different
[[Page 17569]]
additional safety factor when reliable data available to EPA support
the choice of a different factor.
2. Prenatal and postnatal sensitivity. There was no evidence of
increased susceptibility of rat or rabbit fetuses to in utero exposure
or rat pups to post-natal exposure to flutolanil. Flutolanil is not a
developmental or reproductive toxicant. No maternal, reproductive, or
developmental toxicity was observed at the limit dose.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
i. The toxicity database for flutolanil is complete except for
acute and subchronic neurotoxicity and immunotoxicity studies. Recent
changes to 40 CFR part 158 make acute and subchronic neurotoxicity
testing (OPPTS Test Guideline 870.6200), and immunotoxicity testing
(OPPTS Test Guideline 870.7800) required for pesticide registration.
However, the available data for flutolanil do not suggest that the
compound produces hematological or thymus/spleen organ effects
indicative of immunotoxicity. Further, there is no evidence of
neurotoxicity in any study in the toxicity database for flutolanil.
Therefore, EPA does not believe that conducting neurotoxicity and
immunotoxicity studies will result in a NOAEL lower than the NOAEL of
50 milligrams/kilogram/day (mg/kg/day) already established for
flutolanil. Consequently, an additional database uncertainty factor
does not need to be applied.
ii. There is no indication that flutolanil is a neurotoxic chemical
and there is no need for a developmental neurotoxicity study or
additional UFs to account for neurotoxicity.
iii. There is no evidence that flutolanil results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100% CT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground water and surface water modeling
used to assess exposure to flutolanil in drinking water. Residential
exposure does not pose a concern for flutolanil because (1) chronic
residential exposure is not expected; and (2) although short-term or
intermediate-term residential exposure may occur, no relevant adverse
effects were identified for dermal or incidental oral or inhalation
exposure related to residential use. These assessments will not
underestimate the exposure and risks posed by flutolanil.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute population adjusted dose (aPAD) and chronic population adjusted
dose (cPAD). For linear cancer risks, EPA calculates the lifetime
probability of acquiring cancer given the estimated aggregate exposure.
Short-term, intermediate-term, and chronic-term risks are evaluated by
comparing the estimated aggregate food, water, and residential exposure
to the appropriate PODs to ensure that an adequate MOE exists.
1. Acute Risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
flutolanil is not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
flutolanil from food and water will utilize 2% of the cPAD for children
between 1 to 2 years old, the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
flutolanil is not expected.
3. Short-term and intermediate-term risk. Short-term and
intermediate-term aggregate exposure take into account short-term and
intermediate-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Because no short- or intermediate-term adverse effect was
identified, flutolanil is not expected to pose a short-term or
intermediate-term risk.
4. Aggregate cancer risk for U.S. population. EPA has classified
flutolanil as ``not likely'' to be a human carcinogen.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to flutolanil residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
An adequate enforcement methodology, (Method AU/95R/04), a common
moiety Gas Chromatography/Mass Spectrometry (GC/MS) method which
determines residues of flutolanil and metabolites as 2-trifluoromethyl
benzoic acid (2-TFBA) is available to enforce the tolerance expression.
The method 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
Codex maximum residue limits (MRLs) are established for residues of
flutolanil in rice commodities at 1-10 ppm, and in livestock
commodities at 0.05-0.2 ppm. No Canadian or Mexican MRLs have been
established. No Codex MRLs are established for soybean, cotton seed, or
sugar beet commodities.
C. Response to Comments
One comment was received from a private citizen objecting to the
establishment of tolerances for flutolanil. The commenter criticized
EPA's reliance on toxicology testing on animals. The Agency has
received, and responded to, similar comments from this commenter on
numerous previous occasions. Refer to the Federal Register issues of
June 30, 2005 (70 FR 37686), January 7, 2005 (70 FR 1354), October 28,
2004 (FR 69 63096) for the Agency's response to these objections.
D. Revisions to Petitioned-For Tolerances
The Agency is establishing tolerances that are greater than the
proposed tolerance for soybean seed and cotton seed because the
enforcement analytical method has not been validated at a level below
0.20 ppm, and the greater tolerance value is needed to accommodate
indirect residues from soybean rotational crops. Additional tolerances
are established for cotton gin byproducts, as the radiolabeled seed
treatment study revealed residues on cotton gin trash, and soybean hay
to accommodate the seed treatment use and the inadvertent residue from
soybean as a rotational crop.
EPA is revising the tolerance expression in Sec. 180.484 to clarify
that, as provided in FFDCA section 408(a)(3), the tolerance covers
metabolites and degradates of flutolanil not specifically mentioned;
and that compliance with the specified tolerance levels is to be
determined by measuring only the
[[Page 17570]]
specific compounds mentioned in the tolerance expression. The tolerance
definition previously read ``residues of the fungicide flutolanil, N-
(3-(1-methylethoxy)phenyl)-2-(trifluoromethyl)benzamide, and its
metabolites converted to 2-(trifluoromethyl) benzoic acid and
calculated as flutolanil.'' It is being changed to ``residues of
flutolanil, N-(3-(1-methylethoxy)phenyl)-2-(trifluoromethyl)benzamide,
including its metabolites and degradates, in or on the commodities.
Compliance with the tolerance levels is to be determined by measuring
only flutolanil and its metabolites converted to 2-(trifluoromethyl)
benzoic acid and calculated as flutolanil.''
Finally, the inadvertent residue, rotational crop tolerances
previously established for soybean forage and soybean hay encompass the
use on soybean as a seed treatment. Therefore the tolerances
established under paragraph (d), Indirect or inadvertent residues, for
soybean, seed at 0.20 ppm; soybean, forage at 8.0 ppm, and soybean hay
at 2.5 ppm are being revoked since the same tolerance values are being
established under paragraph (a), General.
V. Conclusion
Therefore, tolerances are established for residues of flutolanil,
N-(3-(1-methylethoxy)phenyl)-2-(trifluoromethyl)benzamide, including
its metabolites and degradates, in or on cotton, undelinted seed at
0.20 ppm; soybean, seed at 0.20 ppm; soybean, forage at 8.0 ppm;
soybean, hay at 2.5 ppm; cotton, gin byproducts at 0.20 ppm. Compliance
with the tolerance levels is to be determined by measuring only
flutolanil and its metabolites converted to 2-(trifluoromethyl) benzoic
acid and calculated as flutolanil.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: March 26, 2010.
Lois Rossi,
Director, Registration Division, Office of Pesticide Prorgams.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.484 is amended as follows:
a. Revise the section heading.
b. Revise the introductory text of paragraph (a).
c. Add alphabetically entries to the table in paragraph (a) for
cotton, gin byproducts; cotton, undelinted seed; soybean forage;
soybean, hay; and soybean, seed.
d. Revise paragraph (d).
Sec. 180.484 Flutolanil; tolerances for residues.
(a) General. Tolerances are established for residues of flutolanil,
N-(3-(1-methylethoxy) phenyl)-2-(trifluoromethyl)benzamide, including
its metabolites and degradates, in or on the commodities in the table
below. Compliance with the tolerance levels specified below is to be
determined by measuring only flutolanil and its metabolites converted
to 2-(trifluoromethyl) benzoic acid and calculated as flutolanil, in or
on the following commodities:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * *
Cotton, gin byproducts............................... 0.20
Cotton, undelinted seed.............................. 0.20
* * * * *
Soybean, forage...................................... 8.0
Soybean, hay......................................... 2.5
Soybean, seed........................................ 0.20
------------------------------------------------------------------------
* * * * *
(d) Indirect or inadvertent residues. Tolerances are established
for the indirect or inadvertent residues of
[[Page 17571]]
flutolanil, N-(3-(1-methylethoxy)phenyl)-2-(trifluoromethyl)benzamide,
including its metabolites and degradates, in or on the commodities in
the table below. Compliance with the tolerance levels specified below
is to be determined by measuring only flutolanil and its metabolites
converted to 2-(trifluoromethyl) benzoic acid and calculated as
flutolanil, in or on the following commodities.
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Wheat, bran.......................................... 0.20
Wheat, forage........................................ 2.5
Wheat, grain......................................... 0.05
Wheat, hay........................................... 1.2
Wheat, straw......................................... 0.20
------------------------------------------------------------------------
* * * * *
[FR Doc. 2010-7624 Filed 4-6-10; 8:45 am]
BILLING CODE 6560-50-S