[Federal Register Volume 77, Number 239 (Wednesday, December 12, 2012)]
[Rules and Regulations]
[Pages 73945-73951]
[FR Doc No: 2012-29900]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0541; FRL-9360-3]

Fenpyroximate; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of the
insecticide fenpyroximate in or on multiple commodities identified and
discussed later in this document. In addition, this regulation removes
established tolerances for certain commodities/groups superseded by
this action. The Interregional Research Project Number 4 (IR-4)
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA).

DATES: This regulation is effective December 12, 2012. Objections and
requests for hearings must be received on or before February 11, 2013,
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: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2011-0541, is available either
electronically through http://www.regulations.gov or in hard copy at
the OPP Docket in the Environmental Protection Agency Docket Center
(EPA/DC), located in EPA West, Rm. 3334, 1301 Constitution Ave. NW.,
Washington, DC 20460-0001. The Public Reading Room is open from 8:30
a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Public Reading Room is<PHONE_NUMBER>, and the
telephone number for the OPP Docket is<PHONE_NUMBER>. Please review
the visitor instructions and additional information about the docket
available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Sidney Jackson, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
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).

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 http://ecfr.gpoaccess.gov/cgi/t/

text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab--02.tpl.

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-2011-0541 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
February 11, 2013. 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-2011-0541, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting
comments. Do not submit electronically any information you consider to
be Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection
Agency Docket Center (EPA/DC), Mail Code: 28221T, 1200 Pennsylvania
Ave. NW., Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for
hand delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.htm.

Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of Wednesday, September 7, 2011 (76 FR
55329) (FRL-8886-7), 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 1E7881) by IR-4, Project Headquarters, 500 College Road
East, Suite 201 W, Princeton, NJ 08540; and on Wednesday, May 2, 2012
(77 FR 25954) (FRL-9346-1) for PP 1F7902 by Nichino America, Inc., 4550
New Linden Hill Road, Suite 501, Wilmington, DE 19808. The petitions
requested that 40 CFR 180.566 be amended by establishing tolerances for
residues of the insecticide fenpyroximate, (E)-1,1-dimethylethyl 4-
[[[[(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-yl)
methyene]amino]oxy]methyl]benzoate and its Z-isomer, (Z)-1,1-
dimethylethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-
yl)methylene]amino]oxy]methyl]benzoate, in or on avocado at 0.2 parts
per million (ppm); bean, snap at 0.4 ppm; canistel at 0.2 ppm; cucumber
at 0.25 ppm; fruit, citrus, group 10-10 at 0.6 ppm; fruit, pome, group
11-10 at 0.4 ppm; mango at 0.2 ppm; papaya 0.2 ppm; sapodilla at 0.2
ppm; sapote, black at 0.2 ppm; sapote, mamey at 0.2 ppm; star apple at
0.2 ppm; tea, plucked leaves at 15 ppm; and vegetable, fruiting, group
8-10 at 0.2 ppm; corn, field, grain at 0.02 ppm; corn, field, forage/
silage at 2.0 ppm; corn, field, stover at 7.0 ppm; corn, field,
aspirated fractions at 2.0 ppm; corn, pop, grain at 0.02 ppm; corn,
pop, forage/silage at 2.0 ppm; corn, pop, stover at 7.0 ppm; and corn,
pop, aspirated fractions at 2.0 ppm. In addition, petition 1E7881
proposed to remove established tolerances in or on the raw agricultural
commodities/groups: Fruit, citrus, group 10 at 0.60 ppm; fruit, pome,
group 11 at 0.40 ppm; and vegetable, fruiting, group 8 at 0.20 ppm. The
notices referenced a summary of the respective petition prepared by
Nichino America, Inc., the registrant, available in the docket, http://www.regulations.gov. There were no comments received in response to
these notices of filing. Based upon review of the data supporting the
petitions, EPA is establishing tolerance levels for certain commodities
other than the proposed level. 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 fenpyroximate including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with fenpyroximate
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their
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.
    Fenpyroximate induced moderate acute oral and inhalation toxicity
in rats. It exhibited low dermal acute toxicity and was neither a skin
nor eye irritant. Fenpyroximate was a slight to moderate sensitizer by
the maximization test method. Subchronic and chronic oral exposures to
fenpyroximate resulted in overall systemic toxicity (no specific target
organ/tissue identified). The most sensitive species tested was the
dog. The effects reported in the dog included slight bradycardia,
deficits in food consumption, body weight, body-weight gain, and an
increased incidence of emesis and diarrhea. Emaciation and torpor
(sluggish inactivity) were reported in female dogs at lower dose levels
than males. The highest dose tested in the dog (50 milligrams/kilogram/
day (mg/kg bw/day)) resulted in first- and second-degree heart block,
increased urea concentration, decreased glucose, and altered plasma
electrolyte levels among other signs of toxicity. In subchronic and
chronic studies with rats, the primary effect was decreased body-weight
gain in both sexes with hematological changes (e.g., higher counts of
red blood cells) at higher doses.

    In a rat prenatal developmental toxicity study, a fenpyroximate
dose level that marginally affected maternal body weight and food
consumption also resulted in an increased litter incidence of increased
thoracic ribs, indicating increased prenatal (qualitative)
susceptibility. In the rabbits, there no developmental effects reported
at the levels tested. In the rat two-generation reproductive toxicity
study, there was no indication of increased pre- or post-natal
susceptibility; maternal toxicity (decreased body-weight) and offspring
toxicity (decreased lactational weight gain in both generations)
occurred at the same dose. Reproductive parameters were not affected.
    Acute and subchronic neurotoxicity studies in the rat show no
evidence that fenpyroximate specifically targets the nervous system. In
the acute neurotoxicity study, neurotoxicity signs such as decreases in
motor activity occurred in the presence of other effects including
decreases in body weight and food consumption, and in the absence of
neuropathology. Similar results were noted in a delayed acute
neurotoxicity study in the hen where no effects (neurotoxic or
otherwise) were reported. The results of the rat subchronic
neurotoxicity study did not indicate any neurotoxicity-specific
effects; deficits in body weight and food consumption were the main
effects reported. Effects reported in a rat immunotoxicity study were
limited to decreased body-weight gain, indicating the fenpyroximate
does not directly target the immune system.There is no evidence of
carcinogenic potential for fenpyroximate based on the results of
carcinogenicity studies via the oral route in either the rats or mice
resulting in the carcinogenicity classification of ``not likely'' to be
carcinogenic to humans. Genotoxicity studies including mutagenicity did
not demonstrate any genotoxic potential resulting from fenpyroximate
exposure.
    Specific information on the studies received and the nature of the
adverse effects caused by fenpyroximate 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 http://www.regulations.gov in document: ``Fenpyroximate. Human-Health Risk
Assessment for (1) Proposed Section 3 Uses on Cucumber, Snap Bean,
Avocado, Black Sapote, Canistel, Mamey Sapote, Mango, Papaya,
Sapodilla, Star Apple, Corn (Field, Pop, Silage, and Grown for Seed);
(2) Updated Tolerances for Citrus Fruit- Group 10-10, Pome Fruit Group
11-10, and Fruiting Vegetable Group 8-10; (4) the Establishment of a
Tolerance on Imported Tea; (3) Increase in Maximum Seasonal Application
Rate on Mint; and (4) Proposed Label Amendment to Include Aerial
Applications to Existing Uses on Citrus in Texas, Melons, Fruiting
Vegetables, and Snap Beans,'' dated April 16, 2012 at p. 32 in docket
ID number EPA-HQ-OPP-2011-0541-0005.

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 http://www.epa.gov/pesticides/factsheets/riskassess.htm. A summary of the toxicological
endpoints for fenpyroximate used for human risk assessment is shown in
the following Table.

  Table--Summary of Toxicological Doses and Endpoints for Fenpyroximate 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 (Females 13-50       NOAEL = 5.0 mg/kg bw  aRfD =.............  Prenatal Developmental Toxicity
 years of age).                    UFA = 10x...........  aPAD = 0.05 mg/kg     Study--Rat. LOAEL = 25 mg/kg/day
                                   UFH = 10x...........   bw.                  based on increase in the fetal
                                   FQPA SF = 1x........                        incidence of additional thoracic
                                                                               ribs.
Acute dietary (General population  NOAEL = 37.5 mg/kg    aRfD =.............  Acute Neurotoxicity Study--Rat.
 including infants and children).   bw.                  aPAD = 0.375 mg/kg   LOAEL = 150 mg/kg bw based on
                                   UFA = 10x...........   bw.                  decreased motor activity (total
                                   UFH = 10x...........                        activity counts and total time
                                   FQPA SF = 1x........                        spent in movement) in both sexes,
                                                                               and a reduction in auditory
                                                                               startle response in females at 24
                                                                               hours post dose, and mild
                                                                               dehydration in males.
Chronic dietary (All populations)  NOAEL = 5.0 mg/kg/    cRfD =.............  Chronic toxicity--Dogs.
                                    day.                 cPAD = 0.05 mg/kg/   LOAEL = 15 mg/kg/day based on an
                                   UFA = 10x...........   day.                 increased incidence of
                                   UFH = 10x...........                        bradycardia, diarrhea, and
                                   FQPA SF = 1x........                        decreases in cholesterol, body-
                                                                               weight gain, and food consumption
                                                                               (M); vomiting, diarrhea, excess
                                                                               salivation and decrease
                                                                               cholesterol in females.

Cancer (Oral, dermal, inhalation)                 Classification: ``Not likely to be carcinogen.''
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. mg/kg bw = milligram/kilogram of body weight. 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 fenpyroximate, EPA considered exposure under the
petitioned-for tolerances as well as all existing fenpyroximate
tolerances in 40 CFR 180.566. EPA assessed dietary exposures from
fenpyroximate 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. Such effects were identified
for fenpyroximate. In estimating acute dietary exposure, EPA used food
consumption information from the United States Department of
Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of
Food Intake by Individuals (CSFII). As to residue levels in food, EPA
assumed 100 percent crop treated (PCT), tolerance-level residues for
all commodities, DEEM\TM\ (ver. 7.81) default processing factors for
all commodities except for apple, pear, and grape juice; raisin;
orange, grapefruit, tangerine, lemon and lime juice; tomato paste and
puree; and peppermint and spearmint oil. Chemical-specific data were
used to calculate empirical processing factors for these commodities.
    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, EPA assumed 100 PCT,
tolerance-level residues for all commodities, and DEEM\TM\ (ver. 7.81)
default processing factors for most commodities except for apple, pear,
and grape juice; raisin; orange, grapefruit, tangerine, lemon and lime
juice; tomato paste and puree; and peppermint and spearmint oil.
Chemical-specific data were used to calculate empirical processing
factors for these commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that fenpyroximate does not 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 treated (PCT) information.
EPA did not use anticipated residue or PCT information in the dietary
assessment for fenpyroximate. Tolerance-level residues and 100 PCT 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 fenpyroximate in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of fenpyroximate. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the First Index Reservoir Screening Tool (FIRST), a
Provisional Cranberry Model and Screening Concentration in Ground Water
(SCI-GROW) model, the Agency calculated conservative estimated drinking
water concentrations (EDWCs) of fenpyroximate. Tier 1 EDWCs reflect
exposure in drinking water to the residues of fenpyroximate and its
isomer/degradate, its cis isomer M-1, and its carboxylic acid M-3, all
of which are assumed to have similar toxicity.
    For acute exposures, EDWCs are estimated to be 43 parts per billion
(ppb) for surface water and 0.27 ppb for ground water.
    For chronic exposures, EDWCs are estimated to be 8.6 ppb for
surface water and 0.27 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model.
    For acute dietary risk assessment, the water concentration value of
43 ppb was used to assess the contribution to drinking water.
    For chronic dietary risk assessment, the water concentration of
value 8.6 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). Fenpyroximate 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 fenpyroximate to share a common mechanism of
toxicity with any other substances, and fenpyroximate does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
fenpyroximate 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 Web site at http://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. There is evidence of
increased prenatal (qualitative) susceptibility in a rat prenatal
developmental toxicity study. A dose level that marginally affected
maternal body weight and food consumption also resulted in an increased
litter incidence of increased thoracic ribs. However, concern for pre-
natal and post-natal toxicity to fenpyroximate is low because (1) there
was a clear NOAEL in the rat prenatal developmental toxicity study; (2)
the NOAEL for this developmental study is being used as POD for the
acute dietary risk assessment for the population of concern--females
13-49 years old; (3) in the rabbit, there were no developmental effects
reported at the levels tested, and (4) in the rat two-generation
reproductive toxicity study, there was no indication of increased pre-
or post-natal susceptibility.
    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 for all exposure scenarios. That decision is
based on the following findings:
    i. The toxicity database for fenpyroximate is complete.
    ii. There is no indication that fenpyroximate is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
    iii. There is evidence that fenpyroximate 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. Increased (qualitative) prenatal susceptibility was seen
following oral exposures in the rat developmental toxicity study.
However, for the reasons noted in Unit III.D.2., the concern is low.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessment utilizes tolerance-
level residues (established or recommended) and 100 PCT for all
proposed/established commodities. By using these assumptions, the acute
and chronic exposures/risks will not be underestimated. The dietary
drinking water assessment utilizes water concentration values generated
by models and associated modeling parameters, which are designed to
provide conservative, health-protective, high-end estimates of water
concentrations that will not likely be exceeded. There are no
registered or proposed uses that will result in residential exposure.
These assessments will not underestimate the exposure and risks posed
by fenpyroximate.

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 fenpyroximate will occupy 3.6% of the aPAD for children 1 to 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
fenpyroximate from food and water will utilize 9.0% of the cPAD for
children 1 to 2 years old, the population group receiving the greatest
exposure. There are no residential uses for fenpyroximate.
    3. Short- and intermediate-term risks. Short-term and intermediate-
term aggregate exposure takes into account short-term and intermediate-
term residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
    Short- and intermediate-term adverse effects were identified;
however, fenpyroximate is not registered for any use patterns that
would result in short- and intermediate-term residential exposure.
Short- and intermediate-term risks are assessed based on short- and
intermediate term residential exposures plus chronic dietary exposure.
Because there are no short- and intermediate-term residential exposure
and chronic dietary exposure has already been assessed under the
appropriately protective cPAD (which is at least as protective as the
POD used to assess short- and intermediate-term risks), no further
assessments of short- and intermediate-term risks are necessary. EPA
relies on the chronic dietary risk assessment for evaluating short- and
intermediate-term risks for fenpyroximate.
    4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, fenpyroximate is not expected to pose a cancer risk to humans.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to fenpyroximate residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography with nitrogen/
phosphorus detection (GC/NPD), Method S19, has passed an Agency
validation) and is available to enforce the tolerance expression.
    These methods may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
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.
    Codex MRLs are established for residues of fenpyroximate per se in/
on several crop commodities. Harmonization with the Codex MRLs is not
possible because the U.S. tolerance expressions include both the parent
fenpyroximate and additional metabolites/isomers. However, the Agency
is lowering the pome fruit tolerance from 0.40 ppm to 0.30 ppm in order
to harmonize with the Codex MRL level. Similarly, based on recently

submitted residue data on citrus, EPA is lowering the existing citrus
fruit tolerance from 0.60 ppm to 0.50 ppm in order to harmonize with
the Codex MRL level.

C. Revisions to Petitioned-For Tolerances

    EPA modified/revised certain IR-4 proposed tolerances based on
results from the Organization for Economic Co-operation and Development
(OECD) tolerance calculation procedures in order to determine
appropriate tolerance levels from available U.S. residue data. The
proposed tolerance at 0.20 ppm for avocado, black sapote, mamey sapote,
canistel, mango, papaya, sapodilla, and star apple was lowered to 0.15
ppm. Similarly, proposed tolerances for cucumber and tea, dried were
increased from 0.25 ppm to 0.40 ppm, and from 15 ppm to 20 ppm,
respectively. The submitted residue data for corn grain were not
entered into the tolerance spreadsheet for OECD calculations because
all treated samples showed combined fenpyroximate residues below the
level of quantitation (LOQ) of 0.02 ppm. However, based on available
residue data, EPA established a tolerance for grain, aspirated
fractions at 0.40 ppm to replace proposed tolerances for corn, field
aspirated fractions at 2.0 ppm and corn, pop aspirated fractions at 2.0
ppm. In addition, EPA established a tolerance for corn, refined oil at
0.05 ppm. Also, tolerances for fruit, citrus crop group 10-10 and
fruit, pome, group 11-10 were reduced to 0.50 ppm and 0.30 ppm,
respectively, in order to harmonize with Codex MRL.
    The Agency is deleting the existing tolerance for okra at 0.20 ppm
since it is included in vegetable, fruiting group 8-10 established by
this action. In addition, EPA corrected commodity definitions to comply
with current EPA policy as follows: ``corn, field, forage/silage'' and
``corn, pop, forage/silage'' were corrected to ``corn, field, forage''
and ``corn, pop, forage,'' respectively, and ``tea, plucked leaves''
was corrected to ``tea, dried.''
    Finally, EPA has revised the tolerance expression to clarify (1)
that, as provided in FFDCA section 408(a)(3), the tolerance covers
metabolites and degradates of fenpyroximate not specifically mentioned;
and (2) that compliance with the specified tolerance levels is to be
determined by measuring only the specific compounds mentioned in the
tolerance expression.

V. Conclusion

    Therefore, tolerances are established for residues of the
insecticide fenpyroximate, (E)-1,1-dimethylethyl 4-[[[[(1,3-dimethyl-5-
phenoxy-1H-pyrazol-4-yl)methyene]amino]oxy]methyl]benzoate and its Z-
isomer, (Z)-1,1-dimethylethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1H-pyrazol-
4-yl)methylene]amino]oxy]methyl]benzoate, including its metabolites and
degradates in or on avocado at 0.15 ppm, bean, snap, succulent at 0.40
ppm, canistel at 0.15 ppm, corn, field, grain at 0.02 ppm, corn, field,
forage at 2.0 ppm, corn, field, stover at 7.0 ppm, corn, pop, grain at
0.02 ppm, corn, pop, forage at 2.0 ppm, corn, pop, stover at 7.0 ppm,
corn, field, refined oil at 0.05 ppm, grain, aspirated fractions at
0.40 ppm, cucumber at 0.4 ppm, fruit, citrus, group 10-10 at 0.50 ppm,
fruit, pome, group 11-10 at 0.30 ppm, mango at 0.15 ppm, papaya 0.15
ppm, sapodilla at 0.15 ppm, sapote, black at 0.15 ppm, sapote, mamey at
0.15 ppm, star apple at 0.15 ppm, tea, dried at 20 ppm, and vegetable,
fruiting, group 8-10 at 0.20 ppm.
    Lastly, EPA is removing the entries for ``fruit, citrus, group
10,'' ``fruit, pome, group 11,'' ``okra'' and ``vegetable, fruiting,
group 8'' from the table at 40 CFR 180.566(a)(1) since ``new
tolerances'' established by this action will supersede the existing
tolerances.

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: December 4, 2012.
Lois Rossi,
Director, Registration Division, 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. In Sec.  180.566 revise paragraph (a)(1), and the introductory texts
of paragraphs (a)(2), (a)(3) and (b) to read as follows:

Sec.  180.566  Fenpyroximate; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the
insecticide fenpyroximate, including its metabolites and degradates, in
or on the commodities in the table below. Compliance with the tolerance
levels specified in the table is to be determined by measuring only the
sum of fenpyroximate, (E)-1,1-dimethylethyl 4-[[[[(1,3-dimethyl-5-
phenoxy-1H-pyrazol-4-yl)methylene]amino]oxy]methyl]benzoate and its Z-
isomer, (Z)-1,1-dimethylethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1H-pyrazol-
4-yl)methylene]amino]oxy]methyl]benzoate, calculated as the
stoichiometric equivalent of fenpyroximate.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Almond, hulls..............................................         3.0
Avocado....................................................         0.15
Bean, snap, succulent......................................         0.40
Berry, low growing, subgroup 13-07G........................         1.0
Canistel...................................................         0.15
Citrus, dried pulp.........................................         2.5
Citrus, oil................................................        10
Corn, field, forage........................................         2.0
Corn, field, grain.........................................         0.02
Corn, field, refined oil...................................         0.05
Corn, field, stover........................................         7.0
Corn, pop, forage..........................................         2.0
Corn, pop, grain...........................................         0.02
Corn, pop, stover..........................................         7.0
Cotton, gin byproducts.....................................        10
Cotton, undelinted seed....................................         0.10
Cucumber...................................................         0.40
Fruit, citrus, group 10-10.................................         0.50
Fruit, pome, group 11-10...................................         0.30
Grain, aspirated fractions.................................         0.40
Grape......................................................         1.0
Hop, dried cones...........................................        10
Mango......................................................         0.15
Melon subgroup 9A..........................................         0.10
Nut, tree, group 14........................................         0.10
Papaya.....................................................         0.15
Peppermint, tops...........................................         7.0
Pistachio..................................................         0.10
Sapodilla..................................................         0.15
Sapote, black..............................................         0.15
Sapote, mamey..............................................         0.15
Spearmint, tops............................................         7.0
Star, apple................................................         0.15
Tea, dried \1\.............................................        20
Vegetable, fruiting, group 8-10............................         0.20
------------------------------------------------------------------------
\1\ There are no U.S. Registrations.

    (2) Tolerances are established for residues of the insecticide
fenpyroximate, including its metabolites and degradates, in or on the
commodities in the table below. Compliance with the tolerance levels
specified in the table is to be determined by measuring only the sum of
fenpyroximate, (E)-1,1-dimethylethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1H-
pyrazol-4-yl)methylene]amino]oxy]methyl]benzoate and its metabolites
(E)-4-[(1,3-dimethyl-5-phenoxypyrazol-4-yl)-
methyleneaminooxymethyl]benzoic acid and (E)-1,1-dimethylethyl-2-
hydroxyethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-
yl)methylene]amino]oxy]methyl]benzoate, calculated as the
stoichiometric equivalent of fenpyroximate.
* * * * *
    (3) Tolerances are established for residues of the insecticide
fenpyroximate, including its metabolites and degradates, in or on the
commodities in the table below. Compliance with the tolerance levels
specified in the table is to be determined by measuring only the sum of
fenpyroximate, (E)-1,1-dimethylethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1H-
pyrazol-4-yl)methylene]amino]oxy]methyl]benzoate and its metabolite
(E)-4-[(1,3-dimethyl-5-phenoxypyrazol-4-yl)-
methyleneaminooxymethyl]benzoic acid, calculated as the stoichiometric
equivalent of fenpyroximate.
* * * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances are
established for residues of the insecticide fenpyroximate, including
its metabolites and degradates in or on the commodities in the table
below. Compliance with the tolerance levels specified in the table is
to be determined by measuring only the sum of fenpyroximate, (E)-1,1-
dimethylethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-yl)
methylene]amino]oxy]methyl]benzoate and its Z-isomer, (Z)-1,1-
dimethylethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-
yl)methylene]amino]oxy]methyl]benzoate, calculated as the
stoichiometric equivalent of fenpyroximate.
* * * * *

[FR Doc. 2012-29900 Filed 12-11-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 7 (Tuesday, January 12, 2016)]
[Notices]
[Pages 1454-1455]
[FR Doc No: 2016-00494]

-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange

Commission will hold a Closed Meeting on Thursday, January 14, 2016 at
2 p.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meeting.
Certain staff members who have an interest in the matters also may be
present.
    The General Counsel of the Commission, or her designee, has
certified that, in her opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (7), 9(B) and (10) and 17 CFR
200.402(a)(3), (a)(5), (a)(7), (a)(9)(ii), and (a)(10), permit
consideration of the scheduled matter at the Closed Meeting.
    Commissioner Stein, as duty officer, voted to consider the items
listed for the Closed Meeting in closed session.
    The subject matter of the Closed Meeting will be:
    Institution and settlement of injunctive actions;
    Institution and settlement of administrative proceedings;
    Resolution of litigation claims; and
    Other matters relating to enforcement proceedings.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact the Office of the
Secretary at<PHONE_NUMBER>.

     Dated: January 7, 2016.
Brent J. Fields,
Secretary.
[FR Doc. 2016-00494 Filed 1-8-16; 11:15 am]
BILLING CODE 8011-01-P