Fluxapyroxad; Pesticide Tolerances, 28270-28276 [2012-11602]
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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
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: May 2, 2012.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.930, the table is amended
by adding alphabetically the following
inert ingredients to read as follows:
■
Therefore, 40 CFR chapter I is
amended as follows:
§ 180.930 Inert ingredients applied to
animals; exemptions from the requirement
of a tolerance.
Environmental protection,
Administrative practice and procedure,
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Inert ingredients
Limits
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Acetone (Cas Reg. No. 67–64–1) .................................................................................................
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[FR Doc. 2012–11623 Filed 5–11–12; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2010–0421; FRL–9346–7]
Fluxapyroxad; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of fluxapyroxad
in or on multiple commodities which
are identified and discussed later in this
document. BASF Corporation requested
these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective May
14, 2012. Objections and requests for
hearings must be received on or before
July 13, 2012, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
SUMMARY:
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2010–0421. 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
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ADDRESSES:
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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: Olga
Odiott, Registration Division (7505P),
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; telephone number:
(703) 308–9369; email address:
odiott.olga@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
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Uses
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solvent or cosolvent.
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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
site at https://ecfr.gpoaccess.gov/cgi/t/
text/text-idx?&c=ecfr&tpl=/ecfrbrowse/
Title40/40tab_02.tpl. To access the
OCSPP test guidelines referenced in this
document electronically, please go
https://www.epa.gov/ocspp and select
‘‘Test Methods and Guidelines.’’
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2010–0421 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 July 13, 2012. Addresses for mail
and hand delivery of objections and
hearing requests are provided in 40 CFR
178.25(b).
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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. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit a copy of
your non-CBI objection or hearing
request, identified by docket ID number
EPA–HQ–OPP–2010–0421, by one of
the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
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.
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II. Summary of Petitioned-For
Tolerance
In the Federal Register of June 23,
2010 (75 FR 35803) (FRL–8831–3), EPA
issued a notice pursuant to FFDCA
section 408(d)(3), 21 U.S.C. 346a(d)(3),
announcing the filing of a pesticide
petition (PP 0F7709) by BASF
Corporation, 26 Davis Drive, Research
Triangle Park, NC 27709–3528. The
petition requested that 40 CFR part 180
be amended by establishing tolerances
for residues of the fungicide
fluxapyroxad, 3-(difluoromethyl)-1methyl-N-(3′,4′,5′-trifluoro[1,1′biphenyl]-2-yl)-1H-pyrazole-4carboxamide, in or on multiple
commodities. That notice referenced a
summary of the petition prepared by
BASF Corporation, the registrant, which
is available in the docket, https://
www.regulations.gov. There were no
comments received in response to the
notice of filing. Based on EPA’s review
of the data supporting the petition,
BASF Company revised their petition
(PP 0F7709) by:
1. Proposing tolerances for corn, pop,
grain; corn, sweet kernels plus cobs
with husks removed; and wheat, grain;
2. Decreasing or increasing the
proposed tolerances for various
commodities;
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3. Deleting the proposed tolerance for
vegetable, root, subgroup 1A and
proposing a tolerance for beet, sugar;
and
4. Proposing a tolerance for oilseeds,
group 20.
The reasons for these changes are
explained in Unit IV.C.
III. Aggregate Risk Assessment and
Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal 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 FFDCA section
408(b)(2)(D), and the factors specified in
FFDCA section 408(b)(2)(D), 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 fluxapyroxad
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with fluxapyroxad 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.
Fluxapyroxad is of low acute toxicity
by the oral, dermal and inhalation
routes, is not irritating to the eyes and
skin, and is not a dermal sensitizer. The
primary target organ for fluxapyroxad
exposure via the oral route is the liver
with secondary toxicity in the thyroid
for rats only. Liver toxicity was
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observed in rats, mice, and dogs, with
rats as the most sensitive species for all
durations of exposure. In rats, adaptive
effects of hepatocellular hypertrophy
and increased liver weights and changes
in liver enzyme activities were first
observed. As the dose or duration of
exposure to fluxapyroxad increased,
clinical chemistry changes related to
liver function also occurred, followed
by hepatocellular necrosis, neoplastic
changes in the liver, and tumors.
Thyroid effects were observed only in
rats. These effects were secondary to
changes in liver enzyme regulation,
which increased metabolism of thyroid
hormone, resulting changes in thyroid
hormones, thyroid follicular
hypertrophy and hyperplasia, and
thyroid tumor formation. Tumors were
not observed in species other than rats
or in organs other than the liver and
thyroid.
In accordance with the EPA’s Final
Guidelines for Carcinogen Risk
Assessment (March, 2005),
fluxapyroxad is classified as ‘‘Not likely
to be Carcinogenic to Humans’’ based on
convincing evidence that carcinogenic
effects are not likely below a defined
dose range:
• No treatment-related tumors were
seen in male or female mice when tested
at doses that were adequate to assess
carcinogenicity (including the Limit
Dose);
• Treatment-related liver tumors were
seen in male rats at doses ≥250 parts per
million (ppm) (11 milligrams/kilogram/
day (mg/kg/day)) and in female rats at
doses ≥1,500 ppm (82 mg/kg/day);
• Treatment-related thyroid follicular
cell tumors were seen in male rats only
at doses ≥1,500 ppm (68 mg/kg/day);
• There is no mutagenicity concern
from in vivo or in vitro assays;
• The hypothesized mode of action
(i.e., a non-genotoxic) for each tumor
type (i.e., the liver and thyroid) was
supported by adequate studies that
clearly identified the sequence of key
events, dose-response concordance and
temporal relationship to the tumor
types. The mode of action met the
criteria established by the Agency.
The Agency has determined that the
chronic population adjusted dose
(cPAD) will adequately account for all
chronic effects, including
carcinogenicity, that could result from
exposure to fluxapyroxad.
No evidence of neurotoxicity was
observed in response to repeated
administration of fluxapyroxad. An
acute neurotoxicity study showed
decreased rearing and motor activity.
This occurred on the day of dosing only
and in the absence of histopathological
effects or alterations in brain weights.
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This indicated that any neurotoxic
effects of fluxapyroxad are likely to be
transient and reversible due to
alterations in neuropharmacology and
not from neuronal damage. There were
no neurotoxic effects observed in the
subchronic dietary toxicity study. No
evidence of reproductive toxicity was
observed. Developmental effects
observed in both rats and mice (thyroid
follicular hypertrophy and hyperplasia
in rats and decreased defecation, food
consumption, body weight/body weight
gain, and increased litter loss in rabbits)
occurred at the same doses as those that
caused adverse effects in maternal
animals, indicating no quantitative
susceptibility. Since the maternal
toxicities of thyroid hormone
perturbation in rats and systemic
toxicity in rabbits likely contributed to
the observed developmental effects
there is low concern for qualitative
susceptibility. An immunotoxicity study
in mice showed no evidence of
immunotoxic effects from fluxapyroxad.
Subchronic oral toxicity studies in
rats, developmental toxicity studies in
rabbits, and in vitro and in vivo
genotoxicity studies were performed for
fluxapyroxad metabolites F700F001,
M700F002, and M700F048. Like
fluxapyroxad, no genotoxic effects were
observed for any of these metabolites.
All three metabolites displayed lower
subchronic toxicity via the oral route
than fluxapyroxad, with evidence of
non-specific toxicity (decreased body
weight) observed only for M700F0048 at
the limit dose. Only M700F0048
exhibited developmental toxicity at
doses similar to those that caused
developmental effects in rabbits with
fluxapyroxad treatment. However, these
effects (abortions and resorptions) were
of a different nature than for
fluxapyroxad (paw hyperflexion) and
are considered secondary to maternal
toxicity. The Agency considers these
studies sufficient for hazard
identification and characterization and
concludes that these metabolites do not
have hazards that exceed those of
fluxapyroxad in nature, severity, or
potency.
Specific information on the studies
received and the nature of the adverse
effects caused by fluxapyroxad as well
as the no-observed-adverse-effect-level
(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies can be found at https://
www.regulations.gov in document
‘‘Fluxapyroxad: Human Health Risk
Assessment for Use of New Active
Ingredient on Cereal Grains, Legume
Vegetables (Succulent and Dry), Oil
Seed Crops (Canola and Sunflower),
Peanuts, Pome Fruit, Stone Fruit, Root
and Tuber Vegetables (Potatoes and
Sugar Beets), Fruiting Vegetables, and
Cotton,’’ at page 39 in docket ID number
EPA–HQ–OPP–2010–0421–0005.
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
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 fluxapyroxad used for
human risk assessment is shown in the
following Table.
TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FLUXAPYROXAD FOR USE IN HUMAN HEALTH RISK
ASSESSMENT
Point of departure
and uncertainty/
safety factors
RfD, PAD, LOC for
risk assessment
Study and toxicological effects
Acute dietary (General population including infants and children, and Females 13–49 years of age).
NOAEL = 125 mg/
kg/day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
aRfD = 1.25 mg/kg/
day.
aPAD = 1.25 mg/
kg/day
Acute neurotoxicity study in rats.
LOAEL = 500 mg/kg/day based on decreased motor activity (both sexes) and decreased rearing (males only)
Chronic dietary (All populations). ...........
NOAEL= 2.1 mg/
kg/day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
cRfD = 0.021 mg/
kg/day..
cPAD = 0.021 mg/
kg/day
Chronic toxicity/carcinogenicity study in rats.
LOAEL = 11 mg/kg/day based on non-neoplastic changes
in the liver (foci, masses)
Cancer (Oral, dermal, inhalation). ..........
Classification: Not likely to be carcinogenic to humans at doses sufficient to induce liver and/or thyroid
tumors. Quantification of risk using a non-linear approach (i.e., RfD) will adequately account for all
chronic toxicity, including carcinogenicity.
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Exposure/scenario
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day =
milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c =
chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in
sensitivity among members of the human population (intraspecies).
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
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exposure to fluxapyroxad, EPA
considered exposure under the
petitioned-for tolerances. EPA assessed
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dietary exposures from fluxapyroxad in
food as follows:
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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.
Such effects were identified for
fluxapyroxad. In estimating acute
dietary exposure, EPA used food
consumption information from the U.S.
Department of Agriculture (USDA)
1994–1996 and 1998 Nationwide
Continuing Surveys of Food Intake by
Individuals (CSFII). As to residue levels
in food, tolerance level residues
adjusted to account for metabolites of
concern, 100 percent crop treated (PCT)
assumptions, and Dietary Exposure
Evaluation Model (DEEM) default and
empirical processing factors were used.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the food consumption data
from the USDA 1994–1996 and 1998
CSFII. As to residue levels in food, a
moderately refined chronic dietary
exposure analysis was performed. An
assumption of 100 PCT, and DEEM
default and empirical processing factors
were used for the chronic dietary
analysis. Highest average field trial
(HAFT) residues for parent plus
metabolite were used for all plant
commodities. For livestock
commodities, tolerance level residues
adjusted to account for metabolites of
concern were used.
iii. Cancer. EPA determines whether
quantitative cancer exposure and risk
assessments are appropriate for a fooduse 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 nonlinear 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
data summarized in Unit III.A., EPA has
concluded that a nonlinear RfD
approach is appropriate for assessing
cancer risk to fluxapyroxad. Cancer risk
was assessed using the same exposure
estimates as discussed in Unit III.C.1.ii.,
chronic exposure.
iv. Anticipated residue and percent
crop treated (PCT) information. EPA did
not use anticipated residue or PCT
information in the acute dietary
assessment for fluxapyroxad. Tolerance
level residues and 100 PCT information
were assumed for all food commodities.
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For the chronic dietary assessment
tolerance level residues and 100 PCT
information were assumed for livestock
commodities. HAFT residues for parent
plus metabolite were used for all plant
commodities.
Section 408(b)(2)(E) of FFDCA
authorizes EPA to use available data and
information on the anticipated residue
levels of pesticide residues in food and
the actual levels of pesticide residues
that have been measured in food. If EPA
relies on such information, EPA must
require pursuant to FFDCA section
408(f)(1) that data be provided 5 years
after the tolerance is established,
modified, or left in effect, demonstrating
that the levels in food are not above the
levels anticipated. For the present
action, EPA will issue such data call-ins
as are required by FFDCA section
408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be
required to be submitted no later than
5 years from the date of issuance of
these tolerances.
2. Dietary exposure from drinking
water. The Agency used screening level
water exposure models in the dietary
exposure analysis and risk assessment
for fluxapyroxad in drinking water.
These simulation models take into
account data on the physical, chemical,
and fate/transport characteristics of
fluxapyroxad. Further information
regarding EPA drinking water models
used in pesticide exposure assessment
can be found at https://www.epa.gov/
oppefed1/models/water/index.htm.
Based on the First Index Reservoir
Screening Tool (FIRST), and the
Screening Concentration in Ground
Water (SCI–GROW) models, the
estimated drinking water concentrations
(EDWCs) of fluxapyroxad for acute
exposures are estimated to be 14.1 parts
per billion (ppb) for surface water and
0.087 ppb for ground water. For chronic
exposures the EDWCs are estimated to
be 6.7 ppb for surface water and 0.087
ppb for ground water. Modeled
estimates of drinking water
concentrations were directly entered
into the dietary exposure model. The
EDWCs of 14.1 ppb for surface water
and 0.087 ppb for ground water were
used for the acute and the chronic
dietary assessments, respectively.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., for lawn and garden pest control,
indoor pest control, termiticides, and
flea and tick control on pets).
Fluxapyroxad is not registered for any
specific use patterns that would result
in residential exposure.
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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 fluxapyroxad to
share a common mechanism of toxicity
with any other substances, and
fluxapyroxad does not appear to
produce a toxic metabolite produced by
other substances. For the purposes of
this tolerance action, therefore, EPA has
assumed that fluxapyroxad 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 Web site 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
additional safety factor when reliable
data available to EPA support the choice
of a different factor.
2. Prenatal and postnatal sensitivity.
No evidence of quantitative
susceptibility was observed in a
reproductive and developmental
toxicity study in rats or in
developmental toxicity studies in rats
and rabbits. Developmental toxicity data
in rats showed decreased body weight
and body weight gain in the offspring at
the same dose levels that caused thyroid
follicular hypertrophy/hyperplasia in
parental animals. Effects in rabbits were
limited to paw hyperflexion, a
malformation that is not considered to
result from a single exposure and that
usually reverses as the animal matures.
Developmental effects observed in both
rats and rabbits occurred at the same
doses as those that caused adverse
effects in maternal animals, indicating
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no quantitative susceptibility. The
Agency has low concern for
developmental toxicity because the
observed effects were of low severity,
were likely secondary to maternal
toxicity, and demonstrated clear
NOAELs. Further, the NOAELs for these
effects were at dose levels higher than
the points of departure selected for risk
assessment for repeat-exposure
scenarios. Therefore, based on the
available data and the selection of risk
assessment endpoints that are protective
of developmental effects, there are no
residual uncertainties with regard to
prenatal and/or postnatal toxicity.
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
fluxapyroxad is complete.
ii. There is no indication that
fluxapyroxad is a neurotoxic chemical
and there is no need for a
developmental neurotoxicity study or
additional UFs to account for
neurotoxicity. Neither the acute or the
subchronic neurotoxicity studies
indicated specific neurotoxicity
responses to fluxapyroxad. Because
fluxapyroxad can disrupt thyroid
hormone levels, the Agency considered
the potential for fluxapyroxad to cause
developmental neurotoxicity as a result
of thyroid hormone disruption, which is
more sensitive endpoint than the
endpoints used in a developmental
neurotoxicity study. Based on its
evaluation of thyroid hormone data
submitted for fluxapyroxad and the
ontogeny of thyroid hormone
metabolism, the Agency has determined
that adverse thyroid hormone
disruptions in the young are unlikely to
occur at dose levels as low as the points
of departure chosen for risk assessment.
The Agency has low concern for
neurotoxic effects of fluxapyroxad at
any life stage.
iii. Based on the developmental and
reproductive toxicity studies discussed
in Unit III.D.2., there are no residual
uncertainties with regard to prenatal
and/or postnatal toxicity.
iv. There are no residual uncertainties
identified in the exposure databases.
The dietary food exposure assessments
were performed based on 100 PCT and
tolerance-level residues or field trial
residue data. The dietary risk
assessment is based on reliable data, is
conservative and will not underestimate
dietary exposure to fluxapyroxad. EPA
made conservative (protective)
assumptions in the ground and surface
water modeling used to assess exposure
VerDate Mar<15>2010
14:45 May 11, 2012
Jkt 226001
to fluxapyroxad in drinking water.
These assessments will not
underestimate the exposure and risks
posed by fluxapyroxad.
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 PAD (aPAD) and
chronic PAD (cPAD). For linear cancer
risks, EPA calculates the lifetime
probability of acquiring cancer given the
estimated aggregate exposure. Short-,
intermediate-, and chronic-term risks
are evaluated by comparing the
estimated aggregate food, water, and
residential exposure to the appropriate
PODs to ensure that an adequate MOE
exists.
1. Acute risk. Using the exposure
assumptions discussed in this unit for
acute exposure, the acute dietary
exposure from food and water to
fluxapyroxad will occupy 6% of the
aPAD for children 1–2 years old, the
population group receiving the greatest
exposure.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that chronic exposure to fluxapyroxad
from food and water will utilize 48% of
the cPAD for children 1–2 years old, the
population group receiving the greatest
exposure. There are no residential uses
for fluxapyroxad.
3. Short-term risk. Short-term
aggregate exposure takes into account
short-term residential exposure plus
chronic exposure to food and water
(considered to be a background
exposure level). Fluxapyroxad is not
registered for any use patterns that
would result in short-term residential
exposure and chronic dietary exposure
has already been assessed under the
appropriately protective cPAD.
4. Intermediate-term risk.
Intermediate-term aggregate exposure
takes into account intermediate-term
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level).
Fluxapyroxad is not registered for any
use patterns that would result in
intermediate-term residential exposure
and chronic dietary exposure has
already been assessed under the
appropriately protective cPAD.
5. Aggregate cancer risk for U.S.
population. In accordance with the
EPA’s Final Guidelines for Carcinogen
Risk Assessment (March 2005), EPA
classified fluxapyroxad as ‘‘Not likely to
be Carcinogenic to Humans’’ based on
convincing evidence that carcinogenic
effects are not likely below a defined
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Fmt 4700
Sfmt 4700
dose range. The Agency has determined
that the quantification of risk using the
cPAD for fluxapyroxad will adequately
account for all chronic toxicity,
including carcinogenicity, that could
result from exposure to fluxapyroxad.
As noted above, chronic exposure to
fluxapyroxad from food and water will
utilize 48% of the cPAD for children 1–
2 years old, the population group
receiving the greatest exposure.
6. 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 fluxapyroxad
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
A Liquid Chromatography-Mass
Spectrometer/Mass Spectrometer (LC/
MS/MS) method is available as an
enforcement method. This method uses
reversed-phase High Pressure Liquid
Chromatography (HPLC) with gradient
elution, and includes 2 ion transitions
to be monitored for the parent and the
metabolites M700F008 and M700F048,
so the method also serves as the
confirmatory method.
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
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue limits
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
The Codex Alimentarius is a joint
United Nations Food and Agriculture
Organization/World Health
Organization food standards program,
and it is recognized as an international
food safety standards-setting
organization in trade agreements to
which the United States is a party. EPA
may establish a tolerance that is
different from a Codex MRL; however,
FFDCA section 408(b)(4) requires that
EPA explain the reasons for departing
from the Codex level.
The Codex has not established MRLs
for fluxapyroxad.
E:\FR\FM\14MYR1.SGM
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Federal Register / Vol. 77, No. 93 / Monday, May 14, 2012 / Rules and Regulations
C. Revisions to Petitioned-For
Tolerances
Based on EPA’s review, BASF
Company revised their petition (PP
0F7709) by:
1. Proposing tolerances for corn, pop,
grain; corn, sweet kernels plus cobs
with husks removed; and wheat, grain.
Tolerances for these commodities were
originally proposed as part of the
respective crop group tolerances, but the
Agency determined that separate
tolerances are needed because of
differences between the needed
tolerances and the proposed crop group
tolerances.
2. Decreasing or increasing the
proposed tolerances for various
commodities.
3. Deleting the proposed tolerance for
vegetable, root, subgroup 1A and
proposing a tolerance for beet, sugar.
The submitted data are not sufficient to
support a tolerance for the proposed
subgroup 1A, but it supports a tolerance
for beet, sugar.
4. Deleting tolerances that the Agency
determined are not needed and/or are
covered by other proposed tolerances.
5. Proposing a tolerance for oilseeds,
group 20. The registrant had proposed
tolerances for all the representative
commodities for crop group 20 and the
submitted data supports establishment
of the group tolerance.
The Agency concluded that based on
the residue data these changes are
required to support the proposed uses.
The Agency analyzed the field trial data
for the respective commodities using the
Organization for Economic Cooperation
and Development tolerance calculation
procedures to determine the appropriate
tolerances.
V. Conclusion
Therefore, tolerances are established
for residues of fluxapyroxad, 3(difluoromethyl)-1-methyl-N-(3′,4′,5′trifluoro[1,1′-biphenyl]-2-yl)-1Hpyrazole-4-carboxamide, as requested in
the revised petition.
emcdonald on DSK29S0YB1PROD with RULES
VI. Statutory and Executive Order
Reviews
This final rule establishes tolerances
under FFDCA section 408(d) 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
VerDate Mar<15>2010
14:45 May 11, 2012
Jkt 226001
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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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) (Pub. L. 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
PO 00000
Frm 00039
Fmt 4700
Sfmt 4700
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: May 2, 2012.
Steven Bradbury,
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. Add § 180.666 to subpart C to read
as follows:
■
§ 180.666 Fluxapyroxad; tolerances for
residues.
(a) General. Tolerances are
established for residues of the fungicide
fluxapyroxad, including its metabolites
and degradates, in or on the
commodities listed in the table below.
Compliance with the tolerance levels
specified below is to be determined by
measuring only fluxapyroxad, 3(difluoromethyl)-1-methyl-N-(3′,4′,5′trifluoro[1,1′-biphenyl]-2-yl)-1Hpyrazole-4-carboxamide in or on the
commodity.
Commodity
Apple, wet pomace ...................
Beet, sugar ...............................
Beet, sugar, dried pulp .............
Beet, sugar, tops ......................
Cattle, fat ..................................
Cattle, meat ..............................
Cattle, meat byproducts ...........
Corn, field, grain .......................
Corn, oil ....................................
Corn, pop, grain ........................
Corn, sweet, kernels plus cobs
with husks removed ..............
Cotton, gin byproducts .............
Cotton, undelinted seed ...........
Egg ...........................................
Fruit, pome, group 11 ...............
Fruit, stone, group 12 ...............
Goat, fat ....................................
E:\FR\FM\14MYR1.SGM
14MYR1
Parts per
million
2.0
0.1
0.1
7.0
0.05
0.01
0.03
0.01
0.03
0.01
0.15
0.01
0.01
0.002
0.8
2.0
0.05
28276
Federal Register / Vol. 77, No. 93 / Monday, May 14, 2012 / Rules and Regulations
Commodity
Parts per
million
Goat, meat ................................
Goat, meat byproducts .............
Grain, aspirated fractions .........
Grain, cereal, group 15, (except
corn, field, grain; except
corn, pop, grain; except corn,
kernels plus cobs with husks
removed; except wheat) .......
Grain, cereal, forage, fodder
and straw, group 16 ..............
Horse, fat ..................................
Horse, meat ..............................
Horse, meat byproducts ...........
Milk ...........................................
Oilseeds, group 20 ...................
Pea and bean, dried shelled
except soybean, subgroup
6C ..........................................
Pea and bean, succulent
shelled, subgroup 6B ............
Peanut ......................................
Peanut, refined oil ....................
Plum, prune ..............................
Potato, wet peel ........................
Rice, bran .................................
Rice, hulls .................................
Sheep, fat .................................
Sheep, meat .............................
Sheep, meat byproducts ..........
Soybean, hulls ..........................
Soybean, seed ..........................
Vegetable, foliage of legume,
group 7 ..................................
Vegetables, fruiting, group 8 ....
Vegetable, legume, edible podded, subgroup 6A .................
Vegetable, tuberous and corm,
subgroup 1C .........................
Wheat, bran ..............................
Wheat, grain .............................
0.01
0.03
20.0
This regulation is effective May
14, 2012. Objections and requests for
hearings must be received on or before
July 13, 2012, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
DATES:
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
20
OPP–2010–0425. All documents in the
0.05
docket are listed in the docket index
0.01
available at https://www.regulations.gov.
0.03
0.005 Although listed in the index, some
0.9
information is not publicly available,
e.g., Confidential Business Information
(CBI) or other information whose
0.4
disclosure is restricted by statute.
Certain other material, such as
0.5
copyrighted material, is not placed on
0.01
the Internet and will be publicly
0.02
available only in hard copy form.
3.0
Publicly available docket materials are
0.1
4.5
available in the electronic docket at
8.0
https://www.regulations.gov, or, if only
0.05
available in hard copy, at the OPP
0.01
Regulatory Public Docket in Rm. S–
0.03
4400, One Potomac Yard (South Bldg.),
0.3
2777 S. Crystal Dr., Arlington, VA. The
0.15
Docket Facility is open from 8:30 a.m.
to 4 p.m., Monday through Friday,
30
excluding legal holidays. The Docket
0.7
Facility telephone number is (703) 305–
2.0
5805.
FOR FURTHER INFORMATION CONTACT:
0.02
Marianne Lewis, Registration Division
0.6
(7505P), Office of Pesticide Programs,
0.3
Environmental Protection Agency, 1200
(b) Section 18 emergency exemptions. Pennsylvania Ave. NW., Washington,
DC 20460–0001; telephone number:
[Reserved]
(703) 308–8043; email address:
(c) Tolerances with regional
lewis.marianne@epa.gov.
registrations. [Reserved]
(d) Indirect or inadvertent residues.
SUPPLEMENTARY INFORMATION:
[Reserved]
I. General Information
[FR Doc. 2012–11602 Filed 5–11–12; 8:45 am]
3.0
A. Does this action apply to me?
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2010–0425; FRL–9341–8]
Penflufen; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
emcdonald on DSK29S0YB1PROD with RULES
AGENCY:
This regulation establishes
tolerances for residues of penflufen in or
on multiple commodities which are
identified and discussed later in this
document. Bayer CropScience requested
these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
SUMMARY:
VerDate Mar<15>2010
14:45 May 11, 2012
ADDRESSES:
Jkt 226001
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
PO 00000
Frm 00040
Fmt 4700
Sfmt 4700
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
site at https://ecfr.gpoaccess.gov/cgi/t/
text/text-idx?&c=ecfr&tpl=/ecfrbrowse/
Title40/40tab_02.tpl. To access the
OCSPP test guidelines referenced in this
document electronically, please go
https://www.epa.gov/ocspp and select
‘‘Test Methods and Guidelines.’’
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2010–0425 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 July 13, 2012. 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. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit a copy of
your non-CBI objection or hearing
request, identified by docket ID number
EPA–HQ–OPP–2010–0425, 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
E:\FR\FM\14MYR1.SGM
14MYR1
Agencies
[Federal Register Volume 77, Number 93 (Monday, May 14, 2012)]
[Rules and Regulations]
[Pages 28270-28276]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-11602]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2010-0421; FRL-9346-7]
Fluxapyroxad; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
fluxapyroxad in or on multiple commodities which are identified and
discussed later in this document. BASF Corporation requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective May 14, 2012. Objections and
requests for hearings must be received on or before July 13, 2012, 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-2010-0421. 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: Olga Odiott, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number: (703) 308-9369; email address: odiott.olga@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 site at https://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the
OCSPP test guidelines referenced in this document electronically,
please go https://www.epa.gov/ocspp and select ``Test Methods and
Guidelines.''
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2010-0421 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
July 13, 2012. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
[[Page 28271]]
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. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2010-0421, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online 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. Summary of Petitioned-For Tolerance
In the Federal Register of June 23, 2010 (75 FR 35803) (FRL-8831-
3), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide petition (PP 0F7709)
by BASF Corporation, 26 Davis Drive, Research Triangle Park, NC 27709-
3528. The petition requested that 40 CFR part 180 be amended by
establishing tolerances for residues of the fungicide fluxapyroxad, 3-
(difluoromethyl)-1-methyl-N-(3',4',5'-trifluoro[1,1'-biphenyl]-2-yl)-
1H-pyrazole-4-carboxamide, in or on multiple commodities. That notice
referenced a summary of the petition prepared by BASF Corporation, the
registrant, which is available in the docket, https://www.regulations.gov. There were no comments received in response to the
notice of filing. Based on EPA's review of the data supporting the
petition, BASF Company revised their petition (PP 0F7709) by:
1. Proposing tolerances for corn, pop, grain; corn, sweet kernels
plus cobs with husks removed; and wheat, grain;
2. Decreasing or increasing the proposed tolerances for various
commodities;
3. Deleting the proposed tolerance for vegetable, root, subgroup 1A
and proposing a tolerance for beet, sugar; and
4. Proposing a tolerance for oilseeds, group 20.
The reasons for these changes are explained in Unit IV.C.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal 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 FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), 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 fluxapyroxad including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with fluxapyroxad 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.
Fluxapyroxad is of low acute toxicity by the oral, dermal and
inhalation routes, is not irritating to the eyes and skin, and is not a
dermal sensitizer. The primary target organ for fluxapyroxad exposure
via the oral route is the liver with secondary toxicity in the thyroid
for rats only. Liver toxicity was observed in rats, mice, and dogs,
with rats as the most sensitive species for all durations of exposure.
In rats, adaptive effects of hepatocellular hypertrophy and increased
liver weights and changes in liver enzyme activities were first
observed. As the dose or duration of exposure to fluxapyroxad
increased, clinical chemistry changes related to liver function also
occurred, followed by hepatocellular necrosis, neoplastic changes in
the liver, and tumors. Thyroid effects were observed only in rats.
These effects were secondary to changes in liver enzyme regulation,
which increased metabolism of thyroid hormone, resulting changes in
thyroid hormones, thyroid follicular hypertrophy and hyperplasia, and
thyroid tumor formation. Tumors were not observed in species other than
rats or in organs other than the liver and thyroid.
In accordance with the EPA's Final Guidelines for Carcinogen Risk
Assessment (March, 2005), fluxapyroxad is classified as ``Not likely to
be Carcinogenic to Humans'' based on convincing evidence that
carcinogenic effects are not likely below a defined dose range:
No treatment-related tumors were seen in male or female
mice when tested at doses that were adequate to assess carcinogenicity
(including the Limit Dose);
Treatment-related liver tumors were seen in male rats at
doses >=250 parts per million (ppm) (11 milligrams/kilogram/day (mg/kg/
day)) and in female rats at doses >=1,500 ppm (82 mg/kg/day);
Treatment-related thyroid follicular cell tumors were seen
in male rats only at doses >=1,500 ppm (68 mg/kg/day);
There is no mutagenicity concern from in vivo or in vitro
assays;
The hypothesized mode of action (i.e., a non-genotoxic)
for each tumor type (i.e., the liver and thyroid) was supported by
adequate studies that clearly identified the sequence of key events,
dose-response concordance and temporal relationship to the tumor types.
The mode of action met the criteria established by the Agency.
The Agency has determined that the chronic population adjusted dose
(cPAD) will adequately account for all chronic effects, including
carcinogenicity, that could result from exposure to fluxapyroxad.
No evidence of neurotoxicity was observed in response to repeated
administration of fluxapyroxad. An acute neurotoxicity study showed
decreased rearing and motor activity. This occurred on the day of
dosing only and in the absence of histopathological effects or
alterations in brain weights.
[[Page 28272]]
This indicated that any neurotoxic effects of fluxapyroxad are likely
to be transient and reversible due to alterations in neuropharmacology
and not from neuronal damage. There were no neurotoxic effects observed
in the subchronic dietary toxicity study. No evidence of reproductive
toxicity was observed. Developmental effects observed in both rats and
mice (thyroid follicular hypertrophy and hyperplasia in rats and
decreased defecation, food consumption, body weight/body weight gain,
and increased litter loss in rabbits) occurred at the same doses as
those that caused adverse effects in maternal animals, indicating no
quantitative susceptibility. Since the maternal toxicities of thyroid
hormone perturbation in rats and systemic toxicity in rabbits likely
contributed to the observed developmental effects there is low concern
for qualitative susceptibility. An immunotoxicity study in mice showed
no evidence of immunotoxic effects from fluxapyroxad.
Subchronic oral toxicity studies in rats, developmental toxicity
studies in rabbits, and in vitro and in vivo genotoxicity studies were
performed for fluxapyroxad metabolites F700F001, M700F002, and
M700F048. Like fluxapyroxad, no genotoxic effects were observed for any
of these metabolites. All three metabolites displayed lower subchronic
toxicity via the oral route than fluxapyroxad, with evidence of non-
specific toxicity (decreased body weight) observed only for M700F0048
at the limit dose. Only M700F0048 exhibited developmental toxicity at
doses similar to those that caused developmental effects in rabbits
with fluxapyroxad treatment. However, these effects (abortions and
resorptions) were of a different nature than for fluxapyroxad (paw
hyperflexion) and are considered secondary to maternal toxicity. The
Agency considers these studies sufficient for hazard identification and
characterization and concludes that these metabolites do not have
hazards that exceed those of fluxapyroxad in nature, severity, or
potency.
Specific information on the studies received and the nature of the
adverse effects caused by fluxapyroxad as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at https://www.regulations.gov in document ``Fluxapyroxad: Human Health Risk
Assessment for Use of New Active Ingredient on Cereal Grains, Legume
Vegetables (Succulent and Dry), Oil Seed Crops (Canola and Sunflower),
Peanuts, Pome Fruit, Stone Fruit, Root and Tuber Vegetables (Potatoes
and Sugar Beets), Fruiting Vegetables, and Cotton,'' at page 39 in
docket ID number EPA-HQ-OPP-2010-0421-0005.
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 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 fluxapyroxad used for
human risk assessment is shown in the following Table.
Table--Summary of Toxicological Doses and Endpoints for Fluxapyroxad for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population NOAEL = 125 mg/kg/ aRfD = 1.25 mg/kg/ Acute neurotoxicity study in rats.
including infants and children, day. day. LOAEL = 500 mg/kg/day based on
and Females 13-49 years of age). UFA = 10x........... aPAD = 1.25 mg/kg/ decreased motor activity (both
UFH = 10x........... day. sexes) and decreased rearing
FQPA SF = 1x........ (males only)
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All NOAEL= 2.1 mg/kg/day cRfD = 0.021 mg/kg/ Chronic toxicity/carcinogenicity
populations).. UFA = 10x........... day.. study in rats.
UFH = 10x........... cPAD = 0.021 mg/kg/ LOAEL = 11 mg/kg/day based on non-
FQPA SF = 1x........ day. neoplastic changes in the liver
(foci, masses)
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, Classification: Not likely to be carcinogenic to humans at doses sufficient
inhalation).. to induce liver and/or thyroid tumors. Quantification of risk using a non-
linear approach (i.e., RfD) will adequately account for all chronic
toxicity, including carcinogenicity.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
members of the human population (intraspecies).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to fluxapyroxad, EPA considered exposure under the petitioned-
for tolerances. EPA assessed dietary exposures from fluxapyroxad in
food as follows:
[[Page 28273]]
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.
Such effects were identified for fluxapyroxad. In estimating acute
dietary exposure, EPA used food consumption information from the U.S.
Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue
levels in food, tolerance level residues adjusted to account for
metabolites of concern, 100 percent crop treated (PCT) assumptions, and
Dietary Exposure Evaluation Model (DEEM) default and empirical
processing factors were used.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, a moderately refined
chronic dietary exposure analysis was performed. An assumption of 100
PCT, and DEEM default and empirical processing factors were used for
the chronic dietary analysis. Highest average field trial (HAFT)
residues for parent plus metabolite were used for all plant
commodities. For livestock commodities, tolerance level residues
adjusted to account for metabolites of concern were used.
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 nonlinear 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 data summarized in Unit
III.A., EPA has concluded that a nonlinear RfD approach is appropriate
for assessing cancer risk to fluxapyroxad. Cancer risk was assessed
using the same exposure estimates as discussed in Unit III.C.1.ii.,
chronic exposure.
iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue or PCT information in the acute
dietary assessment for fluxapyroxad. Tolerance level residues and 100
PCT information were assumed for all food commodities. For the chronic
dietary assessment tolerance level residues and 100 PCT information
were assumed for livestock commodities. HAFT residues for parent plus
metabolite were used for all plant commodities.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data
and information on the anticipated residue levels of pesticide residues
in food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for fluxapyroxad in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of fluxapyroxad. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at https://www.epa.gov/oppefed1/models/water/index.htm.
Based on the First Index Reservoir Screening Tool (FIRST), and the
Screening Concentration in Ground Water (SCI-GROW) models, the
estimated drinking water concentrations (EDWCs) of fluxapyroxad for
acute exposures are estimated to be 14.1 parts per billion (ppb) for
surface water and 0.087 ppb for ground water. For chronic exposures the
EDWCs are estimated to be 6.7 ppb for surface water and 0.087 ppb for
ground water. Modeled estimates of drinking water concentrations were
directly entered into the dietary exposure model. The EDWCs of 14.1 ppb
for surface water and 0.087 ppb for ground water were used for the
acute and the chronic dietary assessments, respectively.
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). Fluxapyroxad is not
registered for any specific use patterns that would result in
residential exposure.
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 fluxapyroxad to share a common mechanism of
toxicity with any other substances, and fluxapyroxad does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
fluxapyroxad 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 Web site 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 additional safety factor when
reliable data available to EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity. No evidence of quantitative
susceptibility was observed in a reproductive and developmental
toxicity study in rats or in developmental toxicity studies in rats and
rabbits. Developmental toxicity data in rats showed decreased body
weight and body weight gain in the offspring at the same dose levels
that caused thyroid follicular hypertrophy/hyperplasia in parental
animals. Effects in rabbits were limited to paw hyperflexion, a
malformation that is not considered to result from a single exposure
and that usually reverses as the animal matures. Developmental effects
observed in both rats and rabbits occurred at the same doses as those
that caused adverse effects in maternal animals, indicating
[[Page 28274]]
no quantitative susceptibility. The Agency has low concern for
developmental toxicity because the observed effects were of low
severity, were likely secondary to maternal toxicity, and demonstrated
clear NOAELs. Further, the NOAELs for these effects were at dose levels
higher than the points of departure selected for risk assessment for
repeat-exposure scenarios. Therefore, based on the available data and
the selection of risk assessment endpoints that are protective of
developmental effects, there are no residual uncertainties with regard
to prenatal and/or postnatal toxicity.
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 fluxapyroxad is complete.
ii. There is no indication that fluxapyroxad is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity. Neither the acute or
the subchronic neurotoxicity studies indicated specific neurotoxicity
responses to fluxapyroxad. Because fluxapyroxad can disrupt thyroid
hormone levels, the Agency considered the potential for fluxapyroxad to
cause developmental neurotoxicity as a result of thyroid hormone
disruption, which is more sensitive endpoint than the endpoints used in
a developmental neurotoxicity study. Based on its evaluation of thyroid
hormone data submitted for fluxapyroxad and the ontogeny of thyroid
hormone metabolism, the Agency has determined that adverse thyroid
hormone disruptions in the young are unlikely to occur at dose levels
as low as the points of departure chosen for risk assessment. The
Agency has low concern for neurotoxic effects of fluxapyroxad at any
life stage.
iii. Based on the developmental and reproductive toxicity studies
discussed in Unit III.D.2., there are no residual uncertainties with
regard to prenatal and/or postnatal toxicity.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues or field trial residue data.
The dietary risk assessment is based on reliable data, is conservative
and will not underestimate dietary exposure to fluxapyroxad. EPA made
conservative (protective) assumptions in the ground and surface water
modeling used to assess exposure to fluxapyroxad in drinking water.
These assessments will not underestimate the exposure and risks posed
by fluxapyroxad.
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 PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to fluxapyroxad will occupy 6% of the aPAD for children 1-2 years old,
the population group receiving the greatest exposure.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
fluxapyroxad from food and water will utilize 48% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. There are no residential uses for fluxapyroxad.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Fluxapyroxad
is not registered for any use patterns that would result in short-term
residential exposure and chronic dietary exposure has already been
assessed under the appropriately protective cPAD.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Fluxapyroxad is not registered for any use patterns that would
result in intermediate-term residential exposure and chronic dietary
exposure has already been assessed under the appropriately protective
cPAD.
5. Aggregate cancer risk for U.S. population. In accordance with
the EPA's Final Guidelines for Carcinogen Risk Assessment (March 2005),
EPA classified fluxapyroxad as ``Not likely to be Carcinogenic to
Humans'' based on convincing evidence that carcinogenic effects are not
likely below a defined dose range. The Agency has determined that the
quantification of risk using the cPAD for fluxapyroxad will adequately
account for all chronic toxicity, including carcinogenicity, that could
result from exposure to fluxapyroxad. As noted above, chronic exposure
to fluxapyroxad from food and water will utilize 48% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure.
6. 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 fluxapyroxad residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
A Liquid Chromatography-Mass Spectrometer/Mass Spectrometer (LC/MS/
MS) method is available as an enforcement method. This method uses
reversed-phase High Pressure Liquid Chromatography (HPLC) with gradient
elution, and includes 2 ion transitions to be monitored for the parent
and the metabolites M700F008 and M700F048, so the method also serves as
the confirmatory method.
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
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has not established MRLs for fluxapyroxad.
[[Page 28275]]
C. Revisions to Petitioned-For Tolerances
Based on EPA's review, BASF Company revised their petition (PP
0F7709) by:
1. Proposing tolerances for corn, pop, grain; corn, sweet kernels
plus cobs with husks removed; and wheat, grain. Tolerances for these
commodities were originally proposed as part of the respective crop
group tolerances, but the Agency determined that separate tolerances
are needed because of differences between the needed tolerances and the
proposed crop group tolerances.
2. Decreasing or increasing the proposed tolerances for various
commodities.
3. Deleting the proposed tolerance for vegetable, root, subgroup 1A
and proposing a tolerance for beet, sugar. The submitted data are not
sufficient to support a tolerance for the proposed subgroup 1A, but it
supports a tolerance for beet, sugar.
4. Deleting tolerances that the Agency determined are not needed
and/or are covered by other proposed tolerances.
5. Proposing a tolerance for oilseeds, group 20. The registrant had
proposed tolerances for all the representative commodities for crop
group 20 and the submitted data supports establishment of the group
tolerance.
The Agency concluded that based on the residue data these changes
are required to support the proposed uses. The Agency analyzed the
field trial data for the respective commodities using the Organization
for Economic Cooperation and Development tolerance calculation
procedures to determine the appropriate tolerances.
V. Conclusion
Therefore, tolerances are established for residues of fluxapyroxad,
3-(difluoromethyl)-1-methyl-N-(3',4',5'-trifluoro[1,1'-biphenyl]-2-yl)-
1H-pyrazole-4-carboxamide, as requested in the revised petition.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under FFDCA section 408(d)
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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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) (Pub. L. 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: May 2, 2012.
Steven Bradbury,
Director, Office of Pesticide Programs.
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. Add Sec. 180.666 to subpart C to read as follows:
Sec. 180.666 Fluxapyroxad; tolerances for residues.
(a) General. Tolerances are established for residues of the
fungicide fluxapyroxad, including its metabolites and degradates, in or
on the commodities listed in the table below. Compliance with the
tolerance levels specified below is to be determined by measuring only
fluxapyroxad, 3-(difluoromethyl)-1-methyl-N-(3',4',5'-trifluoro[1,1'-
biphenyl]-2-yl)-1H-pyrazole-4-carboxamide in or on the commodity.
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Apple, wet pomace.......................................... 2.0
Beet, sugar................................................ 0.1
Beet, sugar, dried pulp.................................... 0.1
Beet, sugar, tops.......................................... 7.0
Cattle, fat................................................ 0.05
Cattle, meat............................................... 0.01
Cattle, meat byproducts.................................... 0.03
Corn, field, grain......................................... 0.01
Corn, oil.................................................. 0.03
Corn, pop, grain........................................... 0.01
Corn, sweet, kernels plus cobs with husks removed.......... 0.15
Cotton, gin byproducts..................................... 0.01
Cotton, undelinted seed.................................... 0.01
Egg........................................................ 0.002
Fruit, pome, group 11...................................... 0.8
Fruit, stone, group 12..................................... 2.0
Goat, fat.................................................. 0.05
[[Page 28276]]
Goat, meat................................................. 0.01
Goat, meat byproducts...................................... 0.03
Grain, aspirated fractions................................. 20.0
Grain, cereal, group 15, (except corn, field, grain; except 3.0
corn, pop, grain; except corn, kernels plus cobs with
husks removed; except wheat)..............................
Grain, cereal, forage, fodder and straw, group 16.......... 20
Horse, fat................................................. 0.05
Horse, meat................................................ 0.01
Horse, meat byproducts..................................... 0.03
Milk....................................................... 0.005
Oilseeds, group 20......................................... 0.9
Pea and bean, dried shelled except soybean, subgroup 6C.... 0.4
Pea and bean, succulent shelled, subgroup 6B............... 0.5
Peanut..................................................... 0.01
Peanut, refined oil........................................ 0.02
Plum, prune................................................ 3.0
Potato, wet peel........................................... 0.1
Rice, bran................................................. 4.5
Rice, hulls................................................ 8.0
Sheep, fat................................................. 0.05
Sheep, meat................................................ 0.01
Sheep, meat byproducts..................................... 0.03
Soybean, hulls............................................. 0.3
Soybean, seed.............................................. 0.15
Vegetable, foliage of legume, group 7...................... 30
Vegetables, fruiting, group 8.............................. 0.7
Vegetable, legume, edible podded, subgroup 6A.............. 2.0
Vegetable, tuberous and corm, subgroup 1C.................. 0.02
Wheat, bran................................................ 0.6
Wheat, grain............................................... 0.3
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(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 2012-11602 Filed 5-11-12; 8:45 am]
BILLING CODE 6560-50-P