[Federal Register Volume 84, Number 174 (Monday, September 9, 2019)]
[Rules and Regulations]
[Pages 47130-47136]
[FR Doc No: 2019-19400]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0143; FRL-9998-21]

Abamectin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
abamectin in or on multiple commodities which are identified and
discussed later in this document. Interregional Research Project No. 4
(IR-4) and Syngenta Crop Protection, LLC requested these tolerances
under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective September 9, 2019. Objections and
requests for hearings must be received on or before November 8, 2019,
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-2018-0143, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., 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: Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone
number:

(703) 305-7090; 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.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     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
Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/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-2018-0143 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
November 8, 2019. 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 (excluding any Confidential Business Information (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 the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2018-0143, 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 CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (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.html.
    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 July 24, 2018 (83 FR 34968) (FRL-9980-
31), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions by IR-
4, IR-4 Project Headquarters, Rutgers, The State University of New
Jersey, 500 College Road East, Suite 201W, Princeton, NJ 08540 (PP
8E8664) and Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro,
NC 27419-8300 (PP 7F8642). The petitions requested that 40 CFR part 180
be amended by establishing tolerances for residues of the abamectin, in
or on edible podded legume vegetables subgroup 6A at 0.03 parts per
million (ppm), succulent shelled pea and bean subgroup 6B at 0.005 ppm,
dried shelled pea and bean (except soybean) subgroup 6C at 0.005 ppm
(PP 7F8642) and arugula at 0.10 ppm, carrot, roots at 0.03 ppm, celtuce
at 0.10 ppm, fennel, florence at 0.10 ppm, garden cress at 0.10 ppm,
leaf petiole vegetable subgroup 22B at 0.10 ppm, leafy greens subgroup
4-16A at 0.10 ppm, tropical and subtropical, small fruit, inedible
peel, subgroup 24A at 0.01 ppm, and upland cress at 0.10 ppm (PP
8E8664). The petition 8E8664 also proposed to remove the established
tolerances for lychee at 0.01 ppm and vegetable, leafy, except
brassica, group 4 at 0.10 ppm. That document referenced a summary of
the petitions prepared by Syngenta, the registrant, which is available
in the docket, http://www.regulations.gov. There were no comments
received in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has
modified the level at which some of the tolerances are being
established as well as some of the commodity definitions. The reason
for these changes is 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 abamectin including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with abamectin 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.
    A summary of the toxicological effects of abamectin as well as
specific information on the studies received and the nature of the
adverse effects caused by abamectin and the no-observed-adverse-effect-
level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from
the toxicity studies are discussed in the final rule published in the
Federal Register of May 2, 2016 (81 FR 26147) (FRL-9945-29) and its

supporting documents. Because nothing has changed since the publication
of that rule, EPA is incorporating that discussion into this preamble.

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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for abamectin used for
human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of May 2, 2016 (81 FR 26147) (FRL-
9945-29).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to abamectin, EPA considered exposure under the petitioned-for
tolerances as well as all existing abamectin tolerances in 40 CFR
180.449. EPA assessed dietary exposures from abamectin 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 abamectin. In estimating acute
dietary exposure, EPA used food consumption information from the 2003-
2008 United States Department of Agriculture (USDA) National Health and
Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As
to residue levels in food, a refined acute dietary (food and drinking
water) exposure assessment was conducted for all established food uses
of abamectin except for tea leaves and banana where tolerance-level
residues were used. Otherwise, acute anticipated residues derived from
field trial data were used. Empirical and 2018 DEEM default processing
factors and percent crop treated (PCT) estimates were used, as
available. No monitoring data were used.
    ii. Chronic exposure. The Agency selected a point of departure for
chronic effects that is the same as the point of departure for acute
effects and so is relying on the acute assessment to be protective of
chronic effects. The Agency assessed chronic exposure for purposes of
providing background dietary exposure for use in the residential short-
term assessments and to incorporate residues/exposure from the food
handling establishment (FHE) uses. In conducting the chronic dietary
exposure assessment EPA used the food consumption data from the 2003-
2008 USDA NHANES/WWEIA. As to residue levels in food, a refined chronic
dietary (food and drinking water) exposure assessment was conducted for
all established food uses of abamectin except for tea leaves and banana
where tolerance-level residues were used. Otherwise, average residues
from field trials were used. Residues from use in FHE were included.
Empirical and default processing factors and PCT estimates were used,
as available.
    iii. Cancer. Based on the data cited in Unit III.A., EPA has
concluded that abamectin 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 PCT information. 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.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
     Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food
consumption in a particular area, and the exposure estimate does not
understate exposure for the population in such area.
    In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
    The following maximum PCT estimates for abamectin were used in the
acute dietary risk assessment for the following crops: Almond: 80%;
apple: 30%; apricot: 30%; beans (snap, bush, pole, string): 2.5%;
cantaloupe: 40%; celery: 90%; cherry: 30%; corn: 2.5%; cotton: 30%;
cucumber: 5%; dry beans/peas: 2.5%; grapefruit: 90%; grape (raisin,
table): 40%; grape wine: 30%; hazelnut: 2.5%; lemon: 50%; lettuce: 40%;
lima beans: 30%; onion: 20%; orange: 70%; peach: 30%; peanut: 2.5%;
pear: 80%; peas (fresh, green, sweet): 2.5%; pecan: 10%; pepper: 40%;
pistachio: 2.5%; plum/prune: 30%; potato: 20%; pumpkin: 10%; soybean:
2.5%; spinach: 40%; squash: 10%; strawberry: 60%; sweet corn: 2.5%;
tomato: 30%; walnut: 50%; and watermelon: 10%.
    The PCT values that were used to refine the livestock commodities
for the acute assessment were based on: Corn (2.5%) for beef, goat,
horse, and sheep commodities; and the food handling establishment uses
(5%) for hog (fat, meat, and meat byproducts) and poultry meat and meat
byproducts.
    The following average PCT estimates for abamectin were used in the
chronic dietary risk assessment for the following crops: Almond: 70%;
apple: 15%; apricot: 20%; beans (snap, bush, pole, string): 1%;
cantaloupe: 30%; celery: 50%; cherry: 10%; corn: 1%; cotton: 20%;
cucumber: 2.5%; dry beans/peas: 1%; grapefruit: 80%; grape raisin: 30%;
grape table: 20%; grape wine: 20%; hazelnut: 2.5%; lemon: 40%; lettuce:
30%; lima beans: 10%; onion: 10%; orange: 60%; peach: 20%; peanut: 1%;

pear: 70%; peas (fresh, green, sweet): 1%; pecan: 5%; pepper: 20%;
pistachio: 1%; plum/prune: 20%; potato: 10%; pumpkin: 5%; soybean: 1%;
spinach: 30%; squash: 10%; strawberry: 30%; sweet corn: 1%; tomato:
20%; walnut: 40%; and watermelon: 10%.
    The PCT values that were used to refine the livestock commodities
for the chronic assessment were based on: Corn (1%) for beef, goat,
horse, sheep meat, fat, and meat byproducts; and the food handling
establishment uses (5%) for hog and poultry meat and meat byproducts.
    In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and California Department of
Pesticide Regulation (CalDPR) Pesticide Use Reporting (PUR) for the
chemical/crop combination for the most recent 10 years. EPA uses an
average PCT for chronic dietary risk analysis and a maximum PCT for
acute dietary risk analysis. The average PCT figures for each existing
use are derived by combining available public and private market survey
data for that use, averaging across all observations, and rounding up
to the nearest 5%, except for those situations in which the average PCT
is less than 1% or less than 2.5%. In those cases, the Agency would use
less than 1% or less than 2.5% as the average PCT value, respectively.
The maximum PCT figure is the highest observed maximum value reported
within the most recent 10 years of available public and private market
survey data for the existing use and rounded up to the nearest multiple
of 5%, except where the maximum PCT is less than 2.5%, in which case,
the Agency uses less than 2.5% as the maximum PCT.
    The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which abamectin may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for abamectin in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of abamectin. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Tier I Pesticide Root Zone Model--Ground Water (PRZM-
GW) and Tier I Screening Concentration in Ground Water (SCI-GROW)
models and the Tier II surface water concentration calculator (SWCC)
computer model, the estimated drinking water concentrations (EDWCs) of
abamectin for acute exposures are estimated to be 3.76 parts per
billion (ppb) for surface water and 0.074 ppb for ground water, and for
chronic exposures are estimated to be 1.21 ppb for surface water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For the acute dietary risk
assessment, the Agency used a residue distribution file for water based
upon the maximum single application rate to ornamentals. For the
chronic dietary risk assessment, the water concentration of value 1.21
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).
    Abamectin is currently registered for the following uses that could
result in residential exposures: Golf course turf, professional and
collegiate sports fields, homeowner bait and bait station products that
include an outdoor granular bait formulation for use on fire ant
mounds, and several indoor ready-to-use baits of both dust and gel
formulations.
    EPA assessed residential exposure using the following assumptions:
For residential handlers, both dermal and inhalation short-term
exposure is expected from the currently registered bait and bait
station uses. Residential post-application exposure for adults and
children (6 to <11 and 11 to <16) is possible for the use of abamectin
on golf courses and collegiate and professional sports fields. Adults
and children (6 to <11 and 11 to <16) performing physical post-
application activities may receive dermal exposure to abamectin
residues. For the indoor liquid spray application as a spot or crack
and crevice treatment, residential post-application exposures are
possible. However, for the outdoor liquid spray application, exposures
are expected to be negligible, and therefore, were not quantitatively
assessed. Adults and children performing physical post-application
activities on carpets and hard surfaces may receive exposure to
abamectin residues.
    The following residential post application scenarios were used in
the aggregate assessment because they result in the lowest MOEs: Adults
(dermal) from exposure to collegiate sports field turf; children 11 to
less than 16 years old (dermal) from exposure to golf course turf;
children 6 to less than 11 years old (dermal) from exposure to golf
course turf; and children 1 to less than 2 years old (dermal,
inhalation, and incidental oral) from exposure to carpets.
    Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    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 determined that abamectin and emamectin share
characteristics to support a testable hypothesis for a common mechanism
of action. Consistent with its guidance, the Agency conducted a
screening-level cumulative risk assessment to determine if cumulative
exposures to these chemicals, including the exposures associated with
these new tolerances, would pose a risk of concern. This screening
assessment indicates that that cumulative dietary and residential
aggregate exposures for abamectin and emamectin are below the Agency's

levels of concern. No further cumulative evaluation is necessary for
abamectin and emamectin.
    The Agency's screening-level cumulative analysis can be found at
http://www.regulations.gov in the document titled ``Avermectin
Macrocyclic Lactones, Abamectin and Emamectin. Cumulative Screening
Risk Assessment'' in docket ID number EPA-HQ-OPP-2018-0143.

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. An increase in qualitative
susceptibility was seen in the rabbit developmental toxicity study,
where decreases in body weight and food consumption were seen in
maternal animals at 2.0 mg/kg/day. In contrast, the fetal effects were
much more severe, consisting of cleft palate, clubbed foot, and death
at 2.0 mg/kg/day. The point of departure (0.25 mg/kg/day) selected from
the dog studies is 8x lower than the dose where rabbit fetal effects
were seen. Therefore, it is protective of fetal effects seen in the
rabbit developmental toxicity study.
    The rat reproduction toxicity and developmental neurotoxicity
studies demonstrated both qualitative and quantitative susceptibility
in the pups to the effects of abamectin (decreased pup weights and
increased postnatal pup mortality). This observation is consistent with
the finding that P-glycoprotein (P-gp) is not fully developed in rat
pups until postnatal day 28. Therefore, during the period from birth to
postnatal day 28, the rat pups are substantially more susceptible to
the effects of abamectin than adult rats. However, in humans, P-gp has
been detected in the fetus at 22 weeks of pregnancy, and the human
newborns have functioning P-gp. Therefore, human infants and children
are not expected to have enhanced sensitivity as seen in rat pups.
    3. Conclusion. Currently, the toxicity endpoints and points of
departure for all exposure scenarios are selected from the subchronic
and chronic oral toxicity studies in the dogs. The points of departure
selected from the dog studies are based on clear NOAELs and protective
of all the adverse effects seen in the studies conducted in human
relevant studies with rats, CD-1 mice, and rabbits. Therefore, EPA has
determined that 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 abamectin is complete.
    ii. The proposed mode of action (MOA) is interaction with GABA
receptors leading to neurotoxicity. The findings of neurotoxic signs
observed in the abamectin database are consistent with the proposed
MOA. Signs of neurotoxicity ranging from decreases in foot splay
reflex, mydriasis (i.e., excessive dilation of the pupil), curvature of
the spine, decreased fore- and hind-limb grip strength, tip-toe gate,
tremors, ataxia, or spastic movements of the limbs are reported in
various studies with different durations of abamectin exposure. In
dogs, mydriasis was the most common finding at doses as low as 0.5 mg/
kg/day at one week of treatment. No neuropathology was observed.
Because the PODs used for assessing aggregate exposure to abamectin and
the PODs for assessing cumulative exposure for abamectin and emamectin
are protective of these neurotoxic effects in the U.S. population, as
well as infants and children, no additional data concerning
neurotoxicity is needed at this time to be protective of potential
neurotoxic effects.
    iii. As explained in Unit III.D.2 ``Prenatal and postnatal
sensitivity'', the enhanced susceptibility seen in the rabbit
developmental toxicity, the rat reproduction, and the rat developmental
neurotoxicity studies do not present a risk concern.
    iv. There are no residual uncertainties identified in the exposure
databases. The chronic and acute dietary food exposure assessment are
refined including use of anticipated residues, default processing
factors, and percent crop treated; however, these refinements are
considered protective because field trials are conducted to represent
use conditions leading to the maximum residues in food when the product
is used in accordance with the label and do not underestimate
exposures. EPA made conservative (protective) assumptions in the ground
and surface water modeling used to assess exposure to abamectin in
drinking water. EPA used similarly conservative assumptions to assess
post-application exposure of children. These assessments will not
underestimate the exposure and risks posed by abamectin.

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 abamectin will occupy 66% 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
abamectin from food and water will utilize 4.9% of the cPAD for all
infants less than one year old, the population group receiving the
greatest exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
abamectin is not expected.
    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).
    Abamectin is currently registered for uses that could result in
short-term residential exposure, and the Agency has determined that it
is appropriate to aggregate chronic exposure through food and water
with short-term residential exposures to abamectin.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 840 for adults,
4,200 for children aged 11 to less than 16 years old, 3,200 for
children aged 6 to less than 11 years old, and 200 for children 1 to 2
years old. Because EPA's level of concern for abamectin is a MOE of 100
or below, these MOEs are not of concern.

    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).
    Intermediate-term adverse effects were identified; however,
abamectin is not registered for any use patterns that would result in
intermediate-term residential exposure. Intermediate-term risk is
assessed based on intermediate-term residential exposure plus chronic
dietary exposure. Because there is no 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 intermediate-term risk), no further assessment
of intermediate-term risk is necessary, and EPA relies on the chronic
dietary risk assessment for evaluating intermediate-term risk for
abamectin.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, abamectin is not expected to pose a cancer risk to humans.
    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 abamectin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methods for abamectin in plant and livestock
commodities are available in the Pesticide Analytical Manual, Volume II
(PAM II).

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 U.S. tolerance definition for plants includes avermectin B1a,
avermectin B1b, and the 8,9-Z isomer of avermectin B1a. The tolerance
expression for Codex includes only avermectin B1a. There are Codex
maximum residue limits (MRLs) established on head lettuce, celery, dry
beans, and beans (except broad bean and soybean (immature beans with
pod).
    EPA is establishing tolerances for vegetable, legume, edible
podded, subgroup 6A and vegetable, legume, succulent shelled, subgroup
6B at 0.08 ppm to harmonize with the Codex MRL for beans (except broad
bean and soybean (immature beans with pod)). For the crop group
conversion for leafy greens subgroup 4-16A, the tolerance of 0.1 ppm is
in agreement with the Canadian MRL for a comparable subgroup, so EPA is
not harmonizing with the Codex MRL for only head lettuce at 0.15 ppm.
For leaf petiole vegetables subgroup 22B, harmonization with Codex is
not possible because the residue data underlying the U.S. tolerance
resulted in a tolerance that is higher than the established Codex MRL
on celery (0.1 ppm vs. 0.03 ppm). Harmonizing with the Codex MRL for
celery could result in U.S. growers having violative residues despite
legal use of the pesticide. Finally, EPA is establishing the tolerance
for vegetable, legume, dried shelled, except soybean, subgroup 6C, at
0.01 ppm instead of harmonizing with the Codex MRL of 0.005 ppm for
beans (dry) to be consistent with the Agency's rounding class practice.

C. Revisions to Petitioned-For Tolerances

    EPA modified some of the commodity definitions to be consistent
with Agency nomenclature. Additionally, EPA is establishing several
tolerances at different levels than petitioned for to harmonize with
Codex MRLs or to be consistent with the Agency's rounding class
practice.

V. Conclusion

    Therefore, tolerances are established for residues of abamectin in
or on arugula at 0.1 ppm; carrot, roots at 0.03 ppm; celtuce at 0.1
ppm; fennel, florence, fresh leaves and stalk at 0.1 ppm; garden cress
at 0.1 ppm; leaf petiole vegetable subgroup 22B at 0.1 ppm; leafy
greens subgroup 4-16A at 0.1 ppm; tropical and subtropical, small
fruit, inedible peel, subgroup 24A at 0.01 ppm; upland cress at 0.1
ppm; vegetable, legume, dried shelled, except soybean, subgroup 6C at
0.01 ppm; vegetable, legume, edible podded, subgroup 6A at 0.08 ppm;
and vegetable, legume, succulent shelled, subgroup 6B at 0.08 ppm.
    Additionally, the existing tolerances for lychee and vegetable,
leafy, except brassica group 4 are removed as unnecessary since they
are covered by the newly established tolerances.

VI. Statutory and Executive Order Reviews

    This action establishes and removes 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 action has been
exempted from review under Executive Order 12866, this action 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), nor is it considered a
regulatory action under Executive Order 13771, entitled ``Reducing
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3,
2017). This action 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 tolerances 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 action 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 action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    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 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
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
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: August 28, 2019.
Michael Goodis,
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.  180.449, amend the table in paragraph (a) as follows:
0
a. Add alphabetically the entries ``Arugula''; ``Carrot, roots'';
``Celtuce''; ``Fennel, Florence, fresh leaves and stalk''; ``Garden
cress''; ``Leaf petiole vegetable subgroup 22B''; and ``Leafy greens
subgroup 4-16A'';
0
b. Remove the entry for ``Lychee'';
0
c. Add alphabetically the entries ``Tropical and subtropical, small
fruit, inedible peel, subgroup 24A'' and ``Upland cress'';
0
d. Remove the entry for ``Vegetable, leafy, except brassica group 4'';
and
0
e. Add alphabetically the entries ``Vegetable, legume, dried shelled,
except soybean, subgroup 6C''; ``Vegetable, legume, edible podded,
subgroup 6A''; and ``Vegetable, legume, succulent shelled, subgroup
6B''.
    The additions read as follows:

Sec.  180.449  Avermectin B1 and its delta-8,9-isomer; tolerances for
residues.

    (a) * * *

------------------------------------------------------------------------
                                                                  Parts
                           Commodity                               per
                                                                 million
------------------------------------------------------------------------

                                * * * * *
Arugula.......................................................       0.1

                                * * * * *
Carrot, roots.................................................      0.03

                                * * * * *
Celtuce.......................................................       0.1

                                * * * * *
Fennel, Florence, fresh leaves and stalk......................       0.1

                                * * * * *
Garden cress..................................................       0.1

                                * * * * *
Leaf petiole vegetable subgroup 22B...........................       0.1
Leafy greens subgroup 4-16A...................................       0.1

                                * * * * *
Tropical and subtropical, small fruit, inedible peel, subgroup      0.01
 24A..........................................................
Upland cress..................................................       0.1

                                * * * * *
Vegetable, legume, dried shelled, except soybean, subgroup 6C.      0.01
Vegetable, legume, edible podded, subgroup 6A.................      0.08
Vegetable, legume, succulent shelled, subgroup 6B.............      0.08

                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2019-19400 Filed 9-6-19; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: May 12, 2010 (Volume 75, Number 91)]
[Notices]
[Page 26830-26832]
[DOCID:fr12my10-128]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-62048; File No. SR-ISE-2010-43]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule
Change Relating to Fees and Rebates for Adding and Removing Liquidity

May 6, 2010.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on May 3, 2010, International Securities Exchange, LLC (``ISE'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the Exchange. ISE has
designated this proposal as one establishing or changing a member due,
fee, or other charge imposed under Section 19(b)(3)(A)(ii) of the Act
\3\ and Rule 19b-4(f)(2) thereunder,\4\ which renders the proposal
effective upon filing with the Commission. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The ISE is proposing to amend its Schedule of Fees in order to (i)
increase the number of options classes to be included in the Exchange's
current schedule of transaction fees and rebates for adding and
removing liquidity; and (ii) adopt a rebate for certain orders executed
in the Exchange's Price Improvement Mechanism. The text of the proposed
rule change is available on the Exchange's Web site (http://
www.ise.com), at the principal office of the Exchange, at the
Commission's Public Reference Room, and on the Commission's Web site at
http://www.sec.gov.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of these statements may be examined at
the places specified in Item IV below. The self-regulatory organization
has prepared summaries, set forth in sections A, B and C below, of the
most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to increase liquidity and attract order flow
by amending its transaction fees and rebates for adding and removing

liquidity (``maker/taker fees'').\5\ The Exchange's maker/taker fees
apply to the following categories of market participants: (i) Market
Maker; (ii) Market Maker Plus; \6\ (iii) Non-ISE Market Maker; \7\ (iv)
Firm Proprietary; (v) Customer (Professional); \8\ (vi) Priority
Customer,\9\ 100 or more contracts; and (vii) Priority Customer, less
than 100 contracts.\10\
---------------------------------------------------------------------------

    \5\ These fees are similar to the ``maker/taker'' fees currently
assessed by NASDAQ OMX PHLX (``PHLX''). PHLX currently charges a fee
for removing liquidity to the following class of market
participants: (i) Customer, (ii) Directed Participant, (iii)
Specialist, ROT, SQT and RSQT, (iv) Firm, (v) Broker-Dealer, and
(vi) Professional. PHLX also provides a rebate for adding liquidity
to the following class of market participants: (i) Customer, (ii)
Directed Participant, (iii) Specialist, ROT, SQT and RSQT, and (iv)
Professional. See Securities Exchange Act Release Nos. 61684 (March
10, 2010), 75 FR 13189 (March 18, 2010); 61932 (April 16, 2010), 75
FR 21375 (April 23, 2010); and 61961 (April 22, 2010), 75 FR 22881
(April 30, 2010). See e-mail from Samir M. Patel, Assistant General
Counsel, ISE, to Andrew Madar, Special Counsel, Commission, dated
May 5, 2010.
    \6\ A Market Maker Plus is a market maker who is on the National
Best Bid or National Best Offer 80% of the time in that symbol
during the current trading month for series trading between $0.03
and $5.00 in premium. The Exchange will determine whether a market
maker qualifies as a Market Maker Plus at the end of each month by
looking back at each market maker's quoting statistics during that
month. If at the end of the month, a market maker meets the 80%
criteria, the Exchange will rebate $0.10 per contract for
transactions executed by that market maker during that month. The
Exchange will provide market makers a report on a daily basis with
quoting statistics so that market makers can determine whether or
not they are meeting the 80% criteria.
    \7\ A Non-ISE Market Maker, or Far Away Market Maker
(``FARMM''), is a market maker as defined in Section 3(a)(38) of the
Securities Exchange Act of 1934, as amended (``Exchange Act''),
registered in the same options class on another options exchange.
    \8\ A Customer (Professional) is a person who is not a broker/
dealer and is not a Priority Customer.
    \9\ A Priority Customer is defined in ISE Rule 100(a)(37A) as a
person or entity that is not a broker/dealer in securities, and does
not place more than 390 orders in listed options per day on average
during a calendar month for its own beneficial account(s).
    \10\ The Chicago Board Options Exchange (``CBOE'') currently
makes a similar distinction between large size customer orders that
are fee liable and small size customer orders whose fees are waived.
CBOE currently waives fees for customer orders of 99 contracts or
less in options on exchange-traded funds (``ETFs'') and Holding
Company Depositary Receipts (``HOLDRs'') and charges a transaction
fee for customer orders that exceed 99 contracts. See Securities
Exchange Act Release No. 59892 (May 8, 2009), 74 FR 22790 (May 14,
2009).
---------------------------------------------------------------------------

Current Transaction Charges for Adding and Removing Liquidity

    The Exchange currently assesses a per contract transaction charge
to market participants that remove, or ``take,'' liquidity from the
Exchange in the following three options classes: PowerShares QQQ trust
(``QQQQ''), Bank of America Corporation (``BAC'') and Citigroup, Inc.
(``C''). The per contract transaction charge depends on the category of
market participant submitting an order or quote to the Exchange that
removes liquidity.\11\ Priority Customer Complex orders, regardless of
size, are not assessed a fee for removing liquidity.
---------------------------------------------------------------------------

    \11\ Although these options classes will no longer be subject to
the tiered market maker transaction fees, the volume from these
options classes will continue to be used in the calculation of the
tiers so that this new pricing does not affect a market maker's fee
in all other names.
---------------------------------------------------------------------------

    The Exchange also currently assesses transaction charges for adding
liquidity in options on QQQQ, BAC and C. Priority Customer orders,
regardless of size, and Market Maker Plus orders are not assessed a fee
for adding liquidity.

Current Rebates

    In order to promote and encourage liquidity in options classes that
are subject to maker/taker fees, the Exchange currently offers a $0.10
per contract rebate for Market Maker Plus orders sent to the
Exchange.\12\ Additionally, the Exchange's Facilitation Mechanism has
an auction which allows for participation in a trade by members other
than the member who entered the trade. To incentivize members, the
Exchange currently offers a rebate of $0.15 per contract to contracts
that do not trade with the contra order in the Facilitation Mechanism.
---------------------------------------------------------------------------

    \12\ The concept of incenting market makers with a rebate is not
novel. In 2008, the CBOE established a program for its Hybrid Agency
Liaison whereby it provides a $0.20 per contact rebate to its market
makers provided that at least 80% of the market maker's quotes in a
class during a month are on one side of the national best bid or
offer. Market makers not meeting CBOE's criteria are not eligible to
receive a rebate. See Securities Exchange Act Release No. 57231
(January 30, 2008), 73 FR 6752 (February 5, 2008). The CBOE has
since lowered the criteria from 80% to 60%. See Securities Exchange
Act Release No. 57470 (March 11, 2008), 73 FR 14514 (March 18,
2008).
---------------------------------------------------------------------------

Fee Changes

    The Exchange proposes to add the following 17 options classes to be
included in the Exchange's maker/taker fee schedule: Standard and
Poor's Depositary Receipts/SPDRs (``SPY''), iShares Russell 2000
(``IWM''), Financial Select Sector SPDR (``XLF''), Apple, Inc.
(``AAPL''), General Electric Company (``GE''), JPMorgan Chase & Co.
(``JPM''), Intel Corporation (``INTC''), Goldman Sachs Group, Inc.
(``GS''), Research in Motion Limited (``RIMM''), AT&T, Inc. (``T''),
Verizon Communications, Inc. (``VZ''), United States Natural Gas Fund
(``UNG''), Freeport-McMoRan Copper & Gold, Inc. (``FCX''), Cisco
Systems, Inc. (``CSCO''), Diamonds Trust, Series 1 (``DIA''),
Amazon.com, Inc. (``AMZN'') and United States Steel Corporation
(``X'').
    Additionally, as noted above, to incentivize members, the Exchange
currently offers a rebate of $0.15 per contract to contracts that do
not trade with the contra order in the Exchange's Facilitation
Mechanism. The Exchange proposes to extend that $0.15 per contract
rebate to contracts that do not trade with the contra order in the
Exchange's Price Improvement Mechanism.

Other Fees

     Fees for orders executed in the Exchange's Facilitation,
Solicited Order, Price Improvement and Block Order Mechanisms are for
contracts that are part of the originating or contra order.
     Complex orders executed in the Facilitation and Solicited
Order Mechanisms are charged fees only for the leg of the trade
consisting of the most contracts.
     Payment for Order Flow fees will not be collected on
transactions on QQQQ, BAC, C, SPY, IWM, XLF, AAPL, GE, JPM, INTC, GS,
RIMM, T, VZ, UNG, FCX, CSCO, DIA, AMZN and X options.\13\
---------------------------------------------------------------------------

    \13\ ISE currently has a payment-for-order-flow (``PFOF'')
program that helps the Exchange's market makers establish PFOF
arrangements with an Electronic Access Member (``EAM'') in exchange
for that EAM preferencing some or all of its order flow to that
market maker. This program is funded through a fee paid by Exchange
market makers for each customer contract they execute, and is
administered by both Primary Market Makers (``PMM'') and Competitive
Market Makers (``CMM''), depending to whom the order is preferenced.
---------------------------------------------------------------------------

     The Cancellation Fee will continue to apply in QQQQ, BAC,
C, SPY, IWM, XLF, AAPL, GE, JPM, INTC, GS, RIMM, T, VZ, UNG, FCX, CSCO,
DIA, AMZN and X options.\14\
---------------------------------------------------------------------------

    \14\ The Exchange assesses a Cancellation Fee of $2.00 to EAMs
that cancel at least 500 orders in a month, for each order
cancellation in excess of the total number of orders such member
executed that month. All orders from the same clearing EAM executed
in the same underlying symbol at the same price within a 300 second
period are aggregated and counted as one executed order for purposes
of this fee. This fee is charged only to customer orders.
---------------------------------------------------------------------------

     The Exchange has a $0.20 per contract fee credit for
members who, pursuant to Supplementary Material .02 to Rule 803,
execute a transaction in the Exchange's flash auction as a response to
orders from persons who are not broker/dealers and who are not Priority
Customers.\15\ For QQQQ, BAC, C, SPY, IWM, XLF, AAPL, GE, JPM, INTC,
GS, RIMM, T, VZ, UNG, FCX, CSCO, DIA, AMZN and X options, the Exchange
proposes to lower the per contract fee credit for members who execute a

transaction in the Exchange's flash auction as a response to orders
from persons who are not broker/dealers and who are not Priority
Customers to $0.10 per contract.
---------------------------------------------------------------------------

    \15\ See Securities Exchange Act Release No. 61731 (March 18,
2010), 75 FR 14233 (March 24, 2010).
---------------------------------------------------------------------------

     The Exchange has a $0.20 per contract fee for market maker
orders sent to the Exchange by EAMs.\16\ Market maker orders sent to
the Exchange by EAMs will be assessed a fee of $0.25 per contract for
removing liquidity in QQQQ, BAC, C, SPY, IWM, XLF, AAPL, GE, JPM, INTC,
GS, RIMM, T, VZ, UNG, FCX, CSCO, DIA, AMZN and X options and $0.10 per
contract for adding liquidity in QQQQ, BAC, C, SPY, IWM, XLF, AAPL, GE,
JPM, INTC, GS, RIMM, T, VZ, UNG, FCX, CSCO, DIA, AMZN and X options.
---------------------------------------------------------------------------

    \16\ See Securities Exchange Act Release No. 60817 (October 13,
2009), 74 FR 54111 (October 21, 2009).
---------------------------------------------------------------------------

    The Exchange has designated this proposal to be operative on May 3,
2010.
2. Statutory Basis
    The basis under the Exchange Act for this proposed rule change is
the requirement under Section 6(b)(4) that an exchange have an
equitable allocation of reasonable dues, fees and other charges among
its members and other persons using its facilities. The impact of the
proposal upon the net fees paid by a particular market participant will
depend on a number of variables, most important of which will be its
propensity to add or remove liquidity in QQQQ, BAC, C, SPY, IWM, XLF,
AAPL, GE, JPM, INTC, GS, RIMM, T, VZ, UNG, FCX, CSCO, DIA, AMZN and X
options. The Exchange operates in a highly competitive market in which
market participants can readily direct order flow to another exchange
if they deem fee levels at a particular exchange to be excessive. The
Exchange believes that the proposed fees it charges for options
overlying QQQQ, BAC, C, SPY, IWM, XLF, AAPL, GE, JPM, INTC, GS, RIMM,
T, VZ, UNG, FCX, CSCO, DIA, AMZN and X remain competitive with fees
charged by other exchanges and therefore continue to be reasonable and
equitably allocated to those members that opt to direct orders to the
Exchange rather than to a competing exchange.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The proposed rule change does not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change has become effective pursuant to Section
19(b)(3) of the Act \17\ and Rule 19b-4(f)(2) \18\ thereunder. At any
time within 60 days of the filing of such proposed rule change, the
Commission may summarily abrogate such rule change if it appears to the
Commission that such action is necessary or appropriate in the public
interest, for the protection of investors, or otherwise in furtherance
of the purposes of the Act.
---------------------------------------------------------------------------

    \17\ 15 U.S.C. 78s(b)(3)(A).
    \18\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-ISE-2010-43 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, Station Place, 100 F Street, NE., Washington,
DC 20549-1090.

All submissions should refer to File Number SR-ISE-2010-43. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make publicly available. All
submissions should refer to File Number SR-ISE-2010-43 and should be
submitted on or before June 2, 2010.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\19\
---------------------------------------------------------------------------

    \19\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-11254 Filed 5-11-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 217 (Wednesday, November 9, 2011)]
[Notices]
[Pages 69779-69780]
[FR Doc No: 2011-28995]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-65676; File No. SR-BATS-2011-045]

Self-Regulatory Organizations; BATS Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To Modify
the Market Opening Procedures of BATS Options

November 3, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that, on October 25, 2011, BATS Exchange, Inc. (``Exchange'' or
``BATS'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by the Exchange. The Exchange
has designated the proposed rule change as constituting a non-
controversial rule change under Rule 19b-4(f)(6) under the Act,\3\
which renders the proposal effective upon filing with the Commission.
The Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange is filing with the Commission a proposal to amend the
Rules applicable to the BATS options market (``BATS Options'') in order
to modify the opening procedures for BATS Options. The text of the
proposed rule change is available at the Exchange's Web site at http://www.batstrading.com, at the principal office of the Exchange, and at
the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
Sections A, B, and C below, of the most significant parts of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    BATS Options currently opens options, other than index options,\4\
for trading based on the first transaction after 9:30 a.m. Eastern Time
in the securities underlying the options as reported on the first print
disseminated pursuant to an effective national market system plan. The
Exchange proposes to modify this procedure to wait for the first
transaction on the primary listing market for each underlying security
prior to opening trading in the related options. The Exchange believes
this change is appropriate because on the primary listing market a
security typically opens through an auction mechanism that provides for
additional price discovery as compared to non-listing markets.\5\
Accordingly, the Exchange believes the proposed change will help to
improve the opening process of BATS Options by ensuring that an
underlying security has been opened pursuant to a robust price
discovery process before opening the overlying options for trading.
---------------------------------------------------------------------------

    \4\ BATS Rule 21.7 states that index options will open for
trading at 9:30 a.m. Eastern Time, without requiring an execution in
any underlying security. The Exchange notes that BATS Options does
not currently offer trading of index options.
    \5\ See, e.g., NYSE and NASDAQ.
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2. Statutory Basis
    The Exchange believes that its proposal is consistent with the
requirements of the Act and the rules and regulations thereunder that
are applicable to a national securities exchange, and, in particular,
with the requirements of Section 6(b) of the Act.\6\ In particular, the
proposal is consistent with Section 6(b)(5) of the Act,\7\ because it
would promote just and equitable principles of trade, remove
impediments to, and perfect the mechanism of, a free and open market
and a national market system, and, in general, protect investors and
the public interest. In particular, the proposed rule change will allow
the Exchange to protect investors and the public interest by waiting to
open options for trading until the primary listing market for the
applicable underlying security has opened such security, which should
lead to more accurate prices on BATS Options at the market open.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change imposes
any burden on competition.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    The Exchange has neither solicited nor received written comments on
the proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
by its terms, become operative for 30 days from the date on which it
was filed, or such shorter time as the Commission may designate, it has
become effective

pursuant to Section 19(b)(3)(A) of the Act \8\ and Rule 19b-4(f)(6)
thereunder.\9\
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    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires the self-regulatory organization to submit to the
Commission written notice of its intent to file the proposed rule
change, along with a brief description and text of the proposed rule
change, or such shorter time as designated by the Commission. The
Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    The Exchange has requested that the Commission waive the 30-day
operative delay so that the proposal may become operative immediately
upon filing. The Commission believes that waiver of the 30-day
operative delay would allow the Exchange to immediately implement the
proposed modifications to its market opening procedures, which are
designed to protect investors and other market participants by ensuring
that an underlying security has opened pursuant to a robust price
discovery process before opening of the overlying options for trading.
The Exchange represents that the proposed change will not require a
significant programming effort by Users \10\ of BATS Options or other
market participants and that it expects to have operational and
technological changes in place to support the proposed rule change on
or about November 4, 2011.\11\ As such, the Commission believes that
waiving the 30-day operative delay is consistent with the protection of
investors and the public interest and designates the proposal operative
upon filing.\12\
---------------------------------------------------------------------------

    \10\ As defined in BATS Rule 16.1(a)(62), a ``User'' on BATS
Options is either a member of BATS Options (``Options Member'') or a
sponsored participant who is authorized to obtain access to the
Exchange's system pursuant to BATS Rule 11.3 (``Sponsored
Participant'').
    \11\ See SR-BATS-2011-045, Item 7.
    \12\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-BATS-2011-045 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-BATS-2011-045. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal offices of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-BATS-2011-045, and should be
submitted on or before November 30, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
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    \13\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2011-28995 Filed 11-8-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 143 (Wednesday, July 25, 2012)]
[Notices]
[Page 43592]
[FR Doc No: 2012-18161]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL12-52-001]

System Energy Resources, Inc.; Notice of Filing

    Take notice that on July 18, 2012, System Energy Resources, Inc.
(System Energy Resources), submitted a supplement to its petition filed
on March 28, 2012 (March 28 petition) requesting the Federal Energy
Regulatory Commission issue a declaratory order determining that System
Energy Resources' payment of distributions out of common stock or paid-
in capital to its parent and sole shareholder, Entergy Corporation,
under the circumstances and conditions identified in the petition, will
not violate section 305(a) of the Federal Power Act. In its supplement,
System Energy Resources supplements its March 28 petition to provide
additional information and clarification.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on July 30, 2012.

    Dated: July 19, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-18161 Filed 7-24-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: May 16, 2008 (Volume 73, Number 96)]
[Notices]
[Page 28449]
[DOCID:fr16my08-56]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ID-5703-000]

Wagoner, Gregory E.; Notice of Filing

May 8, 2008.
    Take notice that on April 30, 2008, Gregory E. Wagoner filed an
application to hold an interlocking positions pursuant to section
305(b) of the Federal Power Act, 16 U.S.C. 825d(b) (2000), Part 45 of
the Commission's Regulations, 18 CFR Part 45 (2005) and the
Commission's Order No. 664, 112 FERC ] 61,298 (2005).
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on May 21, 2008.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-10962 Filed 5-15-08; 8:45 am]

BILLING CODE 6717-01-P