[Federal Register Volume 76, Number 96 (Wednesday, May 18, 2011)]
[Rules and Regulations]
[Pages 28675-28682]
[FR Doc No: 2011-11937]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0263; FRL-8865-8]

Spirotetramat; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
spirotetramat, including its metabolites and degradates, in or on
multiple commodities which are identified and discussed later in this
document. Bayer CropScience requested these tolerances under the
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective May 18, 2011. Objections and
requests for hearings must be received on or before July 18, 2011, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2009-0263. All documents in the
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Rita Kumar, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail 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).
    This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.gpoaccess.gov/ecfr. To
access the harmonized test guidelines referenced in this document
electronically, please go to http://www.epa.gov/ocspp and select ``Test
Methods & Guidelines.''

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2009-0263 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
July 18, 2011. 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-2009-0263, by one of the following methods:

     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.

II. Summary of Petitioned-for Tolerance

    In the Federal Register of June 10, 2009 (74 FR 27538) (FRL-8417-
7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
9F7537) by Bayer CropScience LLC, 2 T. W. Alexander Drive, Research
Triangle Park, NC 27709. The petition requested that 40 CFR 180.641 be
amended by establishing tolerances for residues of the insecticide
spirotetramat, (cis-3-(2,5-dimethylphenyl)-8-methoxy-2-oxo-1-
azaspiro[4.5]dec-3-en-4-yl-ethyl carbonate]) and its metabolites BYI
08330-enol (cis-3-(2,5-dimethylphenyl)-4-hydroxy-8-methoxy-1-
azaspiro[4.5]dec-3-en-2-one), BYI 08330-ketohydroxy (cis-3-(2,5-
dimethylphenyl)-3-hydroxy-8-methoxy-1-azaspiro[4.5]decane-2,4-dione),
BYI08330-enol-Glc (cis-3-(2,5-dimethylphenyl)-8-methoxy-2-oxo-1-
azaspiro[4.5]dec-3-en-4-yl beta-D-glucopyranoside), and BYI 08330-mono-
hydroxy (cis-3-(2,5-dimethylphenyl)-4-hydroxy-8-methoxy-1-
azaspiro[4.5]decan-2-one), calculated as spirotetramat equivalents, in
or on pistachio at 0.25 parts per million (ppm); cotton, undelinted
seed at 0.4 ppm; acerola, atemoya, avocado, birida, black sapote,
canistel, cherimoya, custard apple, feijoa, guava, ilama, jaboticaba,
longan, mamey sapote, mango, passionfruit, persimmon, pulasan,
rambutan, sapodilla, soursop, Spanish lime, star apple, starfruit,
sugar apple, wax jambu, and white sapote at 1.5 ppm; vegetables,
legume, group 06 (except soybean) at 4 ppm; plum, prune, dried at 4.5
ppm; vegetables, foliage of legume, except soybean, subgroup 07A at 5
ppm; cotton, gin byproducts at 7 ppm; soybean at 4 ppm; soybean, forage
at 9 ppm; soybean, aspirated grain fractions at 10 ppm; lychee at 12
ppm; and soybean, hay at 16 ppm and okra at 2.5 ppm. That notice
referenced a summary of the petition prepared by Bayer CropScience, the
registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing. A correction notice was published in the Federal
Register on July 23, 2009 (74 FR 36487) (FRL-8425-2), and August 21,
2009 (74 FR 42302) (FRL-8427-1), to add papaya at 1.5 ppm. There were
no comments received in response to the correction notice.
    In the Federal Register of October 26, 2009 (74 FR 54999) (FRL-
8794-2) (docket number EPA-HQ-OPP-2009-0735), EPA also published a
notice pursuant to section 3(c)(4) of the Federal Insecticide,
Rodenticide, and Fungicide Act (FIFRA) as amended, announcing receipt
of an application from Bayer CropScience to register new uses for
Spirotetramat Technical and three end use products (EPA Registration
Numbers 264-1049, 264-1050, 264-1051, 264-1065), on cotton; soybeans;
vegetable, legume, crop group 6; acerola; atemoya; avocado; birida;
black sapote; canistel; cherimoya; custard apple; feijoa; guava; Ilama;
jaboticaba; longan; mamey sapota; mango; papaya; passionfruit;
persimmon; pulasan; rambutan; sapodilla; soursop; Spanish lime; star
apple; starfruit; sugar apple; wax jambu; white sapote; lychee; okra;
pistachio; and dried prune. The Agency provided 30 days for the public
to comment on this notice, and a comment dated November 25, 2009 was
received from the Natural Resources Defense Council (NRDC), expressing
concerns about both human health and environmental effects of
spirotetramat. The heading of those comments referenced the Federal
Register citation of October 26, 2009 (FRL-8794-2) for the Notice of
Receipt (NOR) under FIFRA, but the docket number for this Notice of
Filing (NOF) under the FFDCA (EPA-HQ-OPP-2009-0263). Although that
comment was timely submitted for purposes of the NOR, it was not timely
submitted for purposes of the present NOF. Nevertheless, the Agency has
responded to the human health portion of the comments, which is
relevant to the present NOF. The NRDC comment and the Agency's response
to the human health portion of the comment can be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2009-0263.
    Based upon review of the data supporting the petition, EPA has
revised the tolerance expression; and also revised the proposed
tolerances on most of the commodities. In addition, EPA will be
establishing import only tolerances for cotton, undelinted seed, and
cotton gin byproduct at this time. The reasons for these changes are
explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue.* *
*''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for spirotetramat including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with spirotetramat
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.
    The acute, short-term, and long-term toxicity of spirotetramat is
well understood. Spirotetramat technical demonstrated moderate to low
acute toxicity via the oral, dermal, and inhalation routes.
Spirotetramat is non-irritating to the skin, although it is an irritant
to the eyes and exhibits a skin-sensitization potential in animals and
humans. The thyroid and thymus glands were target organs in oral
subchronic

toxicity studies in the dog; whereas, the testes-epididymides were the
target organs following subchronic oral treatment of rats. Long-term
toxicity studies reflected the short-term toxicological profile of
spirotetramat with the thymus and thyroid as target organs following 1-
year oral exposure of dogs. Chronic exposure of rats to spirotetramat
also reflected the subchronic pattern of testicular toxicity. No
evidence of tumor formation was found following long-term studies of
rodents, and spirotetramat was also negative for mutagenicity and
clastogenicity in several standard in vivo and in vitro assays.
    The reproductive and developmental toxicity potential of
spirotetramat was tested in rats and rabbits. In addition to testicular
histopathology observed following subchronic and chronic exposure of
rats to spirotetramat, male reproductive toxicity was recorded in a 2-
generation reproductive toxicity study. However, development of the
sexual organs of offspring (balano-preputial separation, vaginal
opening) was unaffected. In an investigative study designed to explore
the time of onset of testicular toxicity in rats, decreased epididymal
sperm counts were noted after 10 days of exposure. Similar effects were
observed after repeated dosing with the enol metabolite of
spirotetramat. Developmental toxicity was not observed with
spirotetramat in the absence of maternal toxicity in either the rat or
rabbit.
    Specific information on the studies received and the nature of the
adverse effects caused by spirotetramat 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 ``Spirotetramat. Human-Health Risk
Assessment for Proposed Uses in/on Cotton, Legume Vegetables including
Soybean (Crop Groups 6 and 7a), and Tropical Fruit''; Appendix A pp 39-
47 in docket ID number EPA-HQ-OPP-2009-0263.

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 (LOC) 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 the NOAEL and the LOAEL of concern are
identified. 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) (a = acute or c = chronic) 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.

 Table 1--Summary of Toxicological Doses and Endpoints for Spirotetramat for Use in Human Health Risk Assessment
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                                        Point of departure and
          Exposure/scenario               uncertainty/safety     RfD, PAD, LOC for risk  Study and toxicological
                                               factors                 assessment                effects
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Acute dietary........................  NOAEL = 100 milligrams/  Acute RfD = 1.0 mg/kg/   Acute neurotoxicity
(General population including infants   kilogram/day (mg/kg/     day.                     (rat; gavage) LOAEL =
 and children).                         day).                   aPAD = 1.0 mg/kg/day...   200 mg/kg/day based on
                                       UFA = 10x..............                            clinical signs male
                                       UFH = 10x..............                            and female (M&F) and
                                       FQPA SF = 1x...........                            decreased motor
                                                                                activity (M).
Chronic dietary......................  NOAEL= 5 mg/kg/day.....  Chronic RfD = 0.05 mg/   Chronic toxicity (dog;
(All populations)....................  UFA = 10x..............   kg/day.                  dietary) LOAEL = 20 mg/
                                       UFH = 10x..............  cPAD = 0.05 mg/kg/day..   kg/day based on thymus
                                       FQPA SF = 1x...........                            involution.
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Cancer (Oral, dermal, inhalation)....  Classification: ``Not Likely to be Carcinogenic to Humans'' based on lack
                                            of evidence of carcinogenicity in two oral rodent carcinogenicity
                                                                        studies.
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UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
  of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term
  study for long-term risk assessment. UFDB = to account for the absence of data or other data deficiency. FQPA
  SF = Food Quality Protection Act Safety Factor.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to spirotetramat, EPA considered exposure under the
petitioned-for tolerances as well as all existing spirotetramat
tolerances in 40 CFR 180.641. EPA assessed dietary exposures from
spirotetramat 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 spirotetramat. In estimating acute
dietary exposure, EPA used food consumption information from the U.S.
Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue
levels in food, EPA assumed 100 percent crop treated (PCT) and
tolerance-level residues for all foods. Empirical and Dietary Exposure
Evaluation Model (DEEMTM) (ver. 7.81) default processing
factors were used for processed commodities. Drinking water was
incorporated directly in the dietary assessment using the acute
concentrations for surface water generated by the First Index Reservoir
Screening Tool (FIRST) model.
    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 conducted a
conservative chronic dietary assessment assuming average field-trial
residues, empirical and

DEEMTM (ver. 7.81) default processing factors, and 100 PCT.
Drinking water was incorporated directly in the dietary assessment
using the chronic concentrations for surface water generated by the
FIRST model.
    iii. Cancer. No evidence of carcinogenicity was seen in the cancer
studies performed with spirotetramat on rats and mice, and EPA has
classified spirotetramat as ``not likely'' to be a human carcinogen by
any relevant route of exposure. Therefore, an exposure assessment to
evaluate cancer risk was not conducted.
    iv. Anticipated residue and percent crop treated (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. Tolerance-
level residues and 100 PCT were assumed for all food commodities. The
chronic dietary assessment assumed average field-trial residues and 100
PCT.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for spirotetramat in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of spirotetramat. 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, and Screening Concentration in Ground Water
(SCI-GROW) models, the estimated drinking water concentrations (EDWCs)
of spirotetramat for acute exposures are estimated to be 0.212 parts
per billion (ppb) for surface water and 3.96 x 10-4 ppb for
ground water.
    For chronic exposures, non-cancer assessments are estimated to be
1.37 x 10-3 ppb for surface water and 3.96 x 10-4
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
0.212 ppb was used to assess the contribution to drinking water.
    For chronic dietary risk assessment, the water concentration of
value 1.37 x 10-3 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).
    Spirotetramat 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 spirotetramat to share a common mechanism of
toxicity with any other substances, and spirotetramat does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
spirotetramat does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at 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 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 was no evidence of
increased susceptibility of rat or rabbit to prenatal or postnatal
exposure to spirotetramat. In the rat developmental toxicity study,
toxicity to offspring was observed at the same dose as maternal
toxicity, which was also the limit dose. In the developmental toxicity
study in the rabbit, only maternal toxicity was observed. In both
reproductive toxicity studies, toxicity to offspring (decreased body
weight) was observed at the same dose as parental toxicity. Therefore,
no evidence of increased susceptibility of offspring was found across
four relevant toxicity studies with spirotetramat.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for spirotetramat is complete except for
an immunotoxicity study and a subchronic neurotoxicity study which are
required due to recent amendments to the data requirements in 40 CFR
part 158. Despite the absence of these studies, EPA has reliable data
showing an additional safety factor is not necessary to protect infants
and children. Although the toxicology database for spirotetramat shows
effects in the thymus gland, an organ of the immune system, this
finding does not raise uncertainty given the lack of an immunotoxicity
study. The endpoint selected for risk assessment was based on
accelerated thymus involution and decreased thyroid hormone levels in
the dog. Thymus involution has been demonstrated to occur in animals
when the thyroid is induced to decrease hormone levels, so it is
reasonable to conclude that the thymus involution in these dogs was
secondary to the thyroid effects, rather than a direct effect on the
immune system. The dose at which these effects were observed was chosen
as a point of departure because there was some consistency of dose and
effect seen across the subchronic and chronic toxicity studies.
However, the effects occurred in relatively few animals and thus
selection of this endpoint is considered a very protective point of
departure; it is at least tenfold lower than any other potential point
of departure. With respect to immunotoxicity, no immunotoxic effects
were seen in rats or mice, the species in which immunotoxicity studies
are conducted. Thus, the Agency does not believe that conducting a
functional immunotoxicity study in any rodent species will result in a
lower POD than that currently used for overall risk assessment. For
this reason and because the current POD is considered extremely
protective, a UFDB is not

needed to account for the lack of this study. Data regarding
neurotoxicity is discussed in Unit III. D.3.ii.
    ii. EPA has concluded that spirotetramat is not a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity. Although a subchronic
neurotoxicity study is now required as part of the revisions to 40 CFR
part 158, the existing toxicological database indicates that
spirotetramat is not a neurotoxic chemical in mammals. The only
clinical signs at any dose in the acute neurotoxicity study were
staining of the fur or perianal region with urine and decreased motor
activity. The urine staining that was identified is not considered a
neurotoxic effect and was likely due to a colored metabolite that was
excreted into the urine or feces or to a change in the pH of the urine
due to an excreted metabolite. The decreased motor activity observed is
not considered evidence of neurotoxicity because there were no effects
on movement or gait and there were no confirmatory findings of
neurological pathology. Thus, both of these effects are considered
signs of general toxicity (malaise). Further, the effects seen in the
acute neurotoxicity study are not corroborated by any other study in
the database. Although brain dilation was found in one dog in the 1-
year dog study, EPA concluded that this effect was most likely not
caused by administration of spirotetramat given evidence showing this
to be a congenital anomaly in the test species, and because there is no
other evidence of brain pathology in the database. Finally, the
conclusion that spirotetramat is not a neurotoxic chemical is supported
by the fact that the acute, subchronic and developmental neurotoxcity
studies available for structurally-related compounds (spirodiclofen and
spiromesifen) do not show evidence of neurotoxicity in adults or young.
    iii. There is no evidence that spirotetramat results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level or average field-trial residues. The
submitted residue data for tropical fruit is not appropriate for the
proposed use pattern as the trials were conducted at 2X use rate. The
Agency is thus requesting that the petitioner conduct bridging studies
with lychee and guava (one trial each with four samples per treatment
regimen) in order to determine the relationship between residues
resulting from the labeled use pattern and that used in the submitted
field trials. Based on this relationship, the submitted residue data
will be adjusted and the appropriate tolerances determined. As the
recommended tolerances are based on exaggerated-rate field trial data,
it is likely that any future adjustment of these tolerances will be to
a lower level. This risk assessment is thus likely to over-estimate the
dietary risk from spirotetramat residues in/on tropical fruit. Use of
tolerance levels based on exaggerated application rates in a risk
assessment will tend to overstate exposure even more than the
overestimate usually supplied by use of the assumption of tolerance
level residues. EPA made conservative (protective) assumptions in the
ground water and surface water modeling used to assess exposure to
spirotetramat in drinking water. These assessments will not
underestimate the exposure and risks posed by spirotetramat.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute population adjusted dose (aPAD) and chronic population adjusted
dose (cPAD). For linear cancer risks, EPA calculates the lifetime
probability of acquiring cancer given the estimated aggregate exposure.
Short-, 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 spirotetramat will occupy 11% of the aPAD for children 1-2 years
old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
spirotetramat from food and water will utilize 93% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. There are no residential uses for spirotetramat.
    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).
    Spirotetramat is not registered for any use patterns that would
result in short-term residential exposure. Therefore, the short-term
aggregate risk is the sum of the risk from exposure to spirotetramat
through food and water, which has already been addressed, and will not
be greater than the chronic aggregate risk.
    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).
    Spirotetramat is not registered for any use patterns that would
result in intermediate-term residential exposure. Therefore, the
intermediate-term aggregate risk is the sum of the risk from exposure
to spirotetramat through food and water, which has already been
addressed, and will not be greater than the chronic aggregate risk.
    5. Aggregate cancer risk for U.S. population. No evidence of tumor
formation was found following long-term studies of rodents, and
spirotetramat was also negative for mutagenicity and clastogenicity in
several standard in vivo and in vitro assays. Spirotetramat has been
classified as ``not likely'' to be a human carcinogen by any relevant
route of exposure and is not expected to pose a cancer risk.
    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 spirotetramat residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high performance liquid
chromatography with tandem mass spectrometry (HPLC-MS/MS) is available
to enforce the tolerance expression.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; e-mail 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.
    The Codex has not established a MRL for spirotetramat. Canadian
MRLs have been established and are harmonized with the United States.

C. Response to Comments

    There were no timely comments received in response to the notice of
filing. However, as described in Unit II, the NRDC did submit comments
well after the close of the comment period on the notice of filing that
pertain, in part, to the risk determinations made in this rulemaking.
Both the comment and the Agency's response to the human health portion
of the comment can be found at http://www.regulations.gov in docket ID
number EPA-HQ-OPP-2009-0263.
    In brief, NRDC challenged EPA's determination to remove the
children's safety factor on two grounds. First, NRDC questioned whether
EPA had accurately determined, based on several developmental studies,
that the young did not demonstrate any quantitative sensitivity
compared to adults. NRDC did not assert that the studies showed
quantitative sensitivity but suggested that, given the wide dose
spacing in the studies, if the studies had used a tighter dose spacing,
they might have shown that maternal and fetal effects did not occur at
the same dose. While NRDC makes an interesting theoretical point, the
fact of the matter is that the best data available showed no
sensitivity in the young and, more importantly, these data identify a
clear NOAEL for the effects seen in the young. Thus, EPA has a reliable
basis for choosing a safe dose that is protective of the safety of
infants and children. A finding on the sensitivity of the young is not
determinative by itself on the safety of the pesticide or on the
applicability of the children's safety factor; rather, the fundamental
question is whether there are reliable data on safety. Moreover, the
impact of use of the wide dose spacing here compared to a narrower
spacing of doses is likely to provide a larger margin of safety for
infants and children. A tighter dose spacing may provide greater
precision with regard to the level at which effects occur and do not
occur in the maternal compared to the juvenile animals; however, to the
extent these revised dose levels provide more precise information on
the NOAEL, that NOAEL could only be higher (and potentially
significantly higher given the wide dose spacing). Thus, the wide dose
spacing may very well provide a lower POD (by overstating the NOAEL),
and thus a more conservative basis, for assessing risk.
    Second, NRDC argued that EPA did not adequately take into account
the severity of the effects relating to the young seen in the
spirotetramat database. NRDC cites malformations and skeletal defects
in the rat developmental study, thyroid effects in the chronic dog
study, neurotoxicity (staining of the fur with urine) in a rat study,
and the potential that spirotetramat ``may impair the synthesis of
lipids that are necessary for the formation of cell membranes--
including those of brain cells--and for hormone synthesis.'' EPA
adequately considered each of these effects. As to the malformations
and skeletal defects, EPA notes that while these effects are serious
they occurred at a dose level 10,000 to 20,000 times higher than the
safe dose level chosen by EPA. With regard to the thyroid effects, EPA
believes that it took a very conservative approach to even treating the
observed decrease in thyroid levels as an adverse effect given the
absence of any corroborating signs of thyroid toxicity in the relevant
studies. Notably, these studies show no decreases in thyroid weight, no
thyroid histopathology, no compensatory increases in thyroid
stimulating hormone (TSH), no effect on UDP-glucuronosyltransferase
activity, and no clinical signs of toxicity or changes in body weight
that might result from decreased thyroid output. In any event, there
was a clear NOAEL for these minimal thyroid effects and EPA reduced
this NOAEL by a 100X SF in deriving a safe dose for spirotetramat.
Next, EPA disputes NRDC's claim that spirotetramat has neurotoxic
effects. The staining of the fur seen in one study is not a neurotoxic
effect but likely the result of the use of a colored metabolite in the
study that was excreted in the urine. No other effects in the database
could be corroborated as neurotoxic. Finally, NRDC's speculation that
spirotetramat may interfere with the synthesis of lipids necessary to
cell growth is not supported by the spirotetramat mammalian toxicity
database. While spirotetramat does interfere with lipid biosynthesis in
insects, the mammalian database shows no effects on plasma lipid
parameters such as plasma triglycerides and plasma cholesterol which
would be indicative of disruption of lipid biosynthesis in mammals.

D. Revisions to Petitioned-for Tolerances

    Based on residue data submitted with this petition, several
petitioned-for tolerances were revised. Additionally, as a result of
the potential for increased dietary exposure to livestock, it was
considered necessary to establish a tolerance for eggs and for meat
byproducts of hog and poultry, and revise the tolerances on meat
byproducts of cattle, goat, horse, and sheep. The proposed tolerance on
dried prunes was not required as residues in the processed commodity
are not expected to exceed the tolerance established for the raw
agricultural commodity. A crop group tolerance on tropical fruits was
not established because this is not a recognized crop group. Instead,
tolerances on several individual tropical fruit commodities were
established. Tolerances on sugar apple, atemoya, custard apple,
cherimoya, ilama, soursop, and birida were not established, because
field trial residue data were not submitted. A chart listing the
petitioned-for tolerances and EPA recommended tolerances can be found
at http://www.regulations.gov in document ``Spirotetramat. Human-Health
Risk Assessment for Proposed Uses in/on Cotton, Legume Vegetables
including Soybean (Crop Groups 6 and 7a), and Tropical Fruits'' at page
47 in docket ID number EPA-HQ-OPP-2009-0263.
    EPA has also revised the tolerance expression in paragraphs (a)(1)
and (a)(2) to clarify that, as provided in FFDCA section 408(a)(3), the
tolerance covers metabolites and degradates of spirotetramat not
specifically mentioned; and that compliance with the specified
tolerance levels is to be determined by measuring only the specific
compounds mentioned in the tolerance expression.
    EPA has also added a footnote to currently established tolerances
for onion, bulb, subgroup 3A-07 and strawberry to indicate that
currently there are no U.S. registrations for these commodities. Use on
these two commodities was assessed for import tolerances only.
    EPA is establishing import only tolerances for cotton, undelinted
seed, and cotton gin byproducts at this time, because the use on cotton
under FIFRA, 7 U.S.C. 136 et seq., has not been approved. The Agency
has concerns with potential hazard of toxicity to bees, and use on
cotton cannot be approved

until these concerns have been addressed.

 V. Conclusion

    Therefore, tolerances are established for residues of
spirotetramat, including its metabolites and degradates, in or on the
commodities listed in the regulatory text. Compliance with the
tolerance levels is to be determined by measuring only the sum of
spirotetramat and its metabolites calculated as the stoichiometric
equivalent of spirotetramat, in or on the commodities.
    In addition, the proposed uses and the submitted data also support
permanent tolerances for residues of the insecticide spirotetramat,
including its metabolites and degradates, in or on the commodities
listed in the regulatory text. Compliance with the tolerance levels is
to be determined by measuring only the sum of spirotetramat and its
metabolite, calculated as the stoichiometric equivalent of
spirotetramat, in or on the commodities.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the 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 final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
Tribal governments, on the relationship between the national government
and the States or Tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian Tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Pub. L. 104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: May 2, 2011.
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. Section 180.641 is amended by revising paragraph (a) to read as
follows:

Sec.  180.641  Spirotetramat; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the
insecticide spirotetramat, including its metabolites and degradates, in
or on the commodities in the table below. Compliance with the tolerance
levels specified below is to be determined by measuring only the sum of
spirotetramat (cis-3-(2,5-dimethlyphenyl)-8-methoxy-2-oxo-1-
azaspiro[4.5]dec-3-en-4-yl-ethyl carbonate) and its metabolites cis-3-
(2,5-dimethylphenyl)-4-hydroxy-8-methoxy-1-azaspiro[4.5]dec-3-en-2-one,
cis-3-(2,5-dimethylphenyl)-3-hydroxy-8-methoxy-1-azaspiro[4.5]decane-
2,4-dione, cis-3-(2,5-dimethylphenyl)-8-methoxy-2-oxo-1-
azaspiro[4.5]dec-3-en-4-yl beta-D-glucopyranoside, and cis-3-(2,5-
dimethylphenyl)-4-hydroxy-8-methoxy-1-azaspiro[4.5]decan-2-one,
calculated as the stoichiometric equivalent of spirotetramat, in or on
the following commodities.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Acerola.....................................................        2.5
Almond, hulls...............................................        9.0
Aspirated grain fractions...................................       10.0
Avocado.....................................................        0.60
Black sapote................................................        0.60
Brassica, head and stem, subgroup 5A........................        2.5
Brassica, leafy, subgroup 5B................................        8.0
Canistel....................................................        0.60
Citrus, oil.................................................        6.0
Cotton gin byproducts\1\....................................       10.0
Cotton, undelinted seed\1\..................................        0.30
Feijoa......................................................        0.30
Fruit, citrus, group 10.....................................        0.60
Fruit, pome, group 11.......................................        0.70
Fruit, stone, group 12......................................        4.5
Grape, raisin...............................................        3.0
Guava.......................................................        2.5
Hop, dried cones............................................       10.0
Jaboticaba..................................................        2.5
Longan......................................................       13.0
Lychee......................................................       13.0
Mamey sapote................................................        0.60
Mango.......................................................        0.60
Nut, tree, group 14.........................................        0.25
Okra........................................................        2.5
Onion, bulb, subgroup 3A-07\1\..............................        0.30
Papaya......................................................        2.5
Passionfruit................................................        2.5
Pistachio...................................................        0.25
Potato, flakes..............................................        1.6
Pulasan.....................................................       13.0
Rambutan....................................................       13.0
Sapodilla...................................................        0.60

Small fruit vine climbing subgroup, except fuzzy kiwifruit,         1.3
 subgroup 13-07F............................................
Soybean forage..............................................        8.0
Soybean hay.................................................       16.0
Soybean seed................................................        5.0
Spanish lime................................................        0.60
Star apple..................................................        0.60
Starfruit...................................................        2.5
Strawberry\1\...............................................        0.40
Vegetable, cucurbit, group 9................................        0.30
Vegetable, foliage of legume, except soybean, subgroup 07A..        7.0
Vegetable, fruiting, group 8................................        2.5
Vegetable, legume, group 06, except soybean.................        2.5
Vegetable, leafy, except brassica, group 4..................        9.0
Vegetable, tuberous and corm, subgroup 1C...................        0.60
Wax jambu...................................................        2.5
White sapote................................................        0.60
------------------------------------------------------------------------
\1\ Import tolerance only. There are no U.S. registrations for cotton,
  onion or strawberry.

    (2) Tolerances are also established for residues of the insecticide
spirotetramat, including its metabolites and degradates, in or on the
commodities in the table below. Compliance with the tolerance levels
specified below is to be determined by measuring only the sum of
spirotetramat (cis-3-(2,5-dimethlyphenyl)-8-methoxy-2-oxo-1-
azaspiro[4.5]dec-3-en-4-yl-ethyl carbonate]) and its metabolite cis-3-
(2,5-dimethylphenyl)-4-hydroxy-8-methoxy-1-azaspiro[4.5]dec-3-en-2-one,
calculated as the stoichiometric equivalent of spirotetramat, in or on
the following commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat..................................................       0.02
Cattle, meat.................................................       0.02
Cattle, meat byproducts......................................       0.20
Eggs.........................................................       0.02
Goat, fat....................................................       0.02
Goat, meat...................................................       0.02
Goat, meat byproducts........................................       0.20
Hog, meat byproducts.........................................       0.02
Horse, fat...................................................       0.02
Horse, meat..................................................       0.02
Horse, meat byproducts.......................................       0.20
Milk.........................................................       0.01
Poultry, meat byproducts.....................................       0.02
Sheep, fat...................................................       0.02
Sheep, meat..................................................       0.02
Sheep, meat byproducts.......................................       0.20
------------------------------------------------------------------------

* * * * *
[FR Doc. 2011-11937 Filed 5-17-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 154 (Friday, August 9, 2013)]
[Notices]
[Pages 48732-48734]
[FR Doc No: 2013-19262]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-70115; File No. SR-Phlx-2013-80]

Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of
Filing of Proposed Rule Changes to Its Excess Order Fee

August 5, 2013.
    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 July 26, 2013, NASDAQ OMX PHLX LLC (``Phlx'' or ``Exchange'')
filed with the Securities and Exchange Commission (``SEC'' or
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the Exchange. 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.
---------------------------------------------------------------------------

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

    The Exchange proposes changes to its Excess Order Fee under Section
VIII of the Phlx Fee Schedule. Phlx proposes to implement the proposed
rule change on August 1, 2013. The text of the proposed rule change is
available on the Exchange's Web site at http://nasdaqomxphlx.cchwallstreet.com/nasdaqomxphlx/phlx, 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 aspects of such
statements.

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

1. Purpose
    In 2012, Phlx introduced an Excess Order Fee, imposed on NASDAQ OMX
PSX (``PSX'') market participant identifiers (``MPIDs'') that have
characteristics indicative of inefficient order entry practices.\3\ As
Phlx explained at the time, inefficient order entry practices may place
excessive burdens on the systems of Phlx and its member organizations
and may negatively impact the usefulness and life cycle cost of market
data.\4\ Market participants that flood the market with orders that are
rapidly cancelled or that are priced away from the inside market do
little to support meaningful price discovery.
---------------------------------------------------------------------------

    \3\ Securities Exchange Act Release Nos. 67004 (May 17, 2012),
77 FR 30581 (May 23, 2012) (SR-Phlx-2012-64) (establishing fee);
67271 (June 27, 2012), 77 FR 39537 (July 3, 2012) (SR-Phlx-2012-85)
(modifying terms and conditions of fee).
    \4\ See generally Recommendations Regarding Regulatory Reponses
to the Market Events of May 6, 2010, Joint CFTC-SEC Advisory
Committee on Emerging Regulatory Issues, at 11 (February 18, 2011)
(``The SEC and CFTC should also consider addressing the
disproportionate impact that [high frequency trading] has on
Exchange message traffic and market surveillance costs. . . . The
Committee recognizes that there are valid reasons for algorithmic
strategies to drive high cancellation rates, but we believe that
this is an area that deserves further study. At a minimum, we
believe that the participants of those strategies should properly
absorb the externalized costs of their activity.'').
---------------------------------------------------------------------------

    In general, the determination of whether to impose the fee on a
particular MPID has been made by calculating the ratio between (i)
entered orders, weighted by the distance of the order from the national
best bid or offer (``NBBO''), and (ii) orders that execute in whole or
in part. The fee has been imposed on MPIDs with an ``Order Entry
Ratio'' of more than 100. The Order Entry Ratio is calculated, and the
Excess Order Fee imposed, on a monthly basis. Phlx is now proposing to
modify the fee, such that it will be calculated and assessed on the
basis of all of a member organization's trading activity on PSX, rather
than on an MPID basis. The purpose of this change is to ensure that
member organizations do not act in a manner inconsistent with the
intent of the fee by spreading inefficient order activity across
multiple MPIDs in a manner that allows the MPIDs to avoid a charge that
would not be avoided if all of the member organization's activity were
aggregated. Thus, the change replaces the term ``MPID'' with the term
``member organization'' throughout the text of Rule 7018(d). The rule,
as amended, will operate as follows:
    For each member organization, the Order Entry Ratio will be the
ratio of (i) the member organization's ``Weighted Order Total'' to (ii)
the greater of one (1) or the number of displayed, non-marketable
orders \5\ sent to PSX by the member organization during the month that
execute in full or in part.\6\ The Weighted Order Total is the number
of displayed, non-marketable orders sent to PSX by the member
organization, as adjusted by a ``Weighting Factor.'' The applicable
Weighting Factor is applied to each order based on its price in
comparison to the NBBO at the time of order entry:
---------------------------------------------------------------------------

    \5\ The fee focuses on displayed orders since they have the most
significant impact on investor confusion and the quality of market
data.
    \6\ Thus, in an extreme case where no orders entered by the
member organization executed, this component of the ratio would be
assumed to be 1, so as to avoid the impossibility of dividing by
zero.

------------------------------------------------------------------------
                                                              Weighting
             Order's price versus NBBO at entry                 factor
------------------------------------------------------------------------
Less than 0.20% away.......................................           0x
0.20% to 0.99% away........................................           1x
1.00% to 1.99% away........................................           2x
2.00% or more away.........................................           3x
------------------------------------------------------------------------

    Thus, in calculating the Weighted Order Total, an order that was
more than 2.0% away from the NBBO would be equivalent to three orders
that were 0.50% away. Due to the applicable Weighting Factor of 0x,
orders entered less than 0.20% away from the NBBO would not be included
in the Weighted Order Total, but would be included in the ``executed''
orders component of the Order Entry Ratio if they execute in full or
part.\7\ In addition, member

organizations with a daily average Weighted Order Total of less than
100,000 during the month will not be subject to the Excess Order Fee.
Finally, the fee is based on orders received by Phlx during regular
market hours (generally, 9:30 a.m. to 4:00 p.m.),\8\ and will exclude
orders received at other times, even if they execute during regular
market hours.
---------------------------------------------------------------------------

    \7\ An analogous fee of The NASDAQ Stock Market LLC (``NASDAQ'')
includes an exclusion from both components of the ratio for orders
sent by market makers in securities in which they are registered,
through the MPID applicable to the registration. Although Phlx
recently adopted rules to allow market maker registration on PSX,
the extent of market making to date has been limited. Accordingly,
Phlx has not deemed it necessary to adopt a comparable exclusion. In
the event that market maker participation in PSX increases, Phlx
will evaluate the advisability of adopting an exclusion.
    \8\ Regular market hours may be different in some circumstances,
such as on the day after Thanksgiving, when regular market hours on
all exchanges traditionally end at 1:00 p.m.
---------------------------------------------------------------------------

    The following example illustrates the calculation of the Order
Entry Ratio:
     A member organization enters 15,000,000 displayed,
liquidity-providing orders:
     10,000,000 orders are entered at the NBBO. The Weighting
Factor for these orders is 0x.
     5,000,000 orders are entered at a price that is 1.50% away
from the NBBO. The Weighting Factor for these orders is 2x.
     Of the 15,000,000 orders included in the calculation,
90,000 are executed.
     The Weighted Order Total is (10,000,000 x 0) + (5,000,000
x 2) = 10,000,000. The Order Entry Ratio is 10,000,000/90,000 = 111.
    If a member organization has an Order Entry Ratio of more than 100,
the amount of the Order Entry Fee will be calculated by determining the
member organization's ``Excess Weighted Orders.'' Excess Weighted
Orders are calculated by subtracting (i) the Weighted Order Total that
would result in the member organization having an Order Entry Ratio of
100 from (ii) the member organization's actual Weighted Order Total. In
the example above, the Weighted Order Total that would result in an
Order Entry Ratio of 100 is 9,000,000, since 9,000,000/90,000 = 100.
Accordingly, the Excess Weighted Orders would be 10,000,000-9,000,000 =
1,000,000.
    The Excess Order Fee charged to the member organization will then
be determined by multiplying the ``Applicable Rate'' by the number of
Excess Weighted Orders. The Applicable Rate is determined based on the
member organization's Order Entry Ratio:

------------------------------------------------------------------------
                                                              Applicable
                     Order entry ratio                           rate
------------------------------------------------------------------------
101-1,000..................................................       $0.005
More than 1,000............................................        0.01
------------------------------------------------------------------------

    In the example above, the Applicable Rate would be $0.005, based on
the member organization's Order Entry Ratio of 111. Accordingly, the
monthly Excess Order Fee would be 1,000,000 x $0.005 = $5,000.
    Phlx continues to expect that the impact of the fee, as modified,
will be narrow because the change will encourage potentially affected
market participants to modify their order entry practices in order to
avoid the fee, thereby improving the market for all participants.
Accordingly, Phlx does not expect to earn significant revenues from the
modified fee.
2. Statutory Basis
    Phlx believes that the proposed rule change is consistent with the
provisions of Section 6 of the Act,\9\ in general, and with Sections
6(b)(4) and 6(b)(5) of the Act,\10\ in particular, in that it provides
for the equitable allocation of reasonable dues, fees and other charges
among members and issuers and other persons using any facility or
system which Phlx operates or controls, and is not designed to permit
unfair discrimination between customers, issuers, brokers, or dealers.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78f.
    \10\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

    With respect to the Excess Order Fee, Phlx stated in its original
filing to institute the fee that it is reasonable because it is
designed to achieve improvements in the quality of displayed liquidity
and market data that will benefit all market participants. In addition,
although the level of the fee may theoretically be very high, the fee
is reasonable because market participants may readily avoid the fee by
making improvements in their order entry practices that reduce the
number of orders they enter, bring the prices of their orders closer to
the NBBO, and/or increase the percentage of their orders that execute.
Similarly, the change proposed herein is reasonable because it will
provide further incentive to member organizations to improve order
entry practices by insuring that they cannot evade the fee by spreading
activity across multiple MPIDs.
    For similar reasons, the fee is consistent with an equitable
allocation of fees, because although the fee may apply to only a small
number of market participants, the fee would be applied to them in
order to encourage better order entry practices that will benefit all
market participants. The change is also equitable because it will
further encourage better order entry practices across a wider group of
market participants. Finally, Phlx believes that the fee is not
unfairly discriminatory. Although the fee may apply to only a small
number of market participants, it will be imposed because of the
negative externalities that such market participants impose on others
through inefficient order entry practices. Accordingly, Phlx believes
that it is fair to impose the fee on these market participants in order
to incentivize them to modify their behavior and thereby benefit the
market. The change is likewise not unfairly discriminatory because it
will negatively affect member organizations only if they have been
evading the incentives to improve order entry practices provided by the
fee.

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

    Phlx does not believe that the proposed rule change will result in
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act, as amended.\11\ Phlx notes that
it operates in a highly competitive market in which market participants
can readily favor competing venues if they deem fee levels at a
particular venue to be excessive, or rebate opportunities available at
other venues to be more favorable. In such an environment, Phlx must
continually adjust its fees to remain competitive with other exchanges
and with alternative trading systems that have been exempted from
compliance with the statutory standards applicable to exchanges, while
also seeking to earn a reasonable profit from its trading and routing
services. Because competitors are free to modify their own fees in
response, and because market participants may readily adjust their
order routing practices, Phlx believes that the degree to which fee
changes in this market may impose any burden on competition is
extremely limited. With respect to the change to the Excess Order Fee,
Phlx believes that the change, like the original fee, will constrain
market participants from pursuing certain inefficient and potentially
abusive trading strategies. To the extent that this change may be
construed as a burden on competition, Phlx believes that it is
appropriate in order to allow Phlx to better achieve this purpose.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78f(b)(8).
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C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were either solicited or received.

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)(A) of the Act \12\ and paragraph (f) of Rule 19b-4
thereunder.\13\ 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.
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    \12\ 15 U.S.C. 78s(b)(3)(A).
    \13\ 17 CFR 240.19b-4(f).
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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-Phlx-2013-80 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-Phlx-2013-80. 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 on official business
days between the hours of 10:00 a.m. and 3:00 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-Phlx-2013-80, and should be submitted on or before
August 30, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
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    \14\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-19262 Filed 8-8-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 251 (Tuesday, December 31, 2013)]
[Notices]
[Pages 79714-79715]
[FR Doc No: 2013-31242]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension:
    Rule 17f-5 OMB Control No.: 3235-0269, SEC File No. 270-259

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 350l-3520), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collection of
information summarized below. The Commission plans to submit the
existing collection of information to the Office of

Management and Budget for extension and approval.
    Rule 17f-5 (17 CFR 270.17f-5) under the Investment Company Act of
1940 [15 U.S.C. 80a] (the ``Act'') governs the custody of the assets of
registered management investment companies (``funds'') with custodians
outside the United States. Under rule 17f-5, a fund or its foreign
custody manager (as delegated by the fund's board) may maintain the
fund's foreign assets in the care of an eligible fund custodian under
certain conditions. If the fund's board delegates to a foreign custody
manager authority to place foreign assets, the fund's board must find
that it is reasonable to rely on each delegate the board selects to act
as the fund's foreign custody manager. The delegate must agree to
provide written reports that notify the board when the fund's assets
are placed with a foreign custodian and when any material change occurs
in the fund's custody arrangements. The delegate must agree to exercise
reasonable care, prudence, and diligence, or to adhere to a higher
standard of care. When the foreign custody manager selects an eligible
foreign custodian, it must determine that the fund's assets will be
subject to reasonable care if maintained with that custodian, and that
the written contract that governs each custody arrangement will provide
reasonable care for fund assets. The contract must contain certain
specified provisions or others that provide at least equivalent care.
The foreign custody manager must establish a system to monitor the
performance of the contract and the appropriateness of continuing to
maintain assets with the eligible foreign custodian.
    The collection of information requirements in rule 17f-5 are
intended to provide protection for fund assets maintained with a
foreign bank custodian whose use is not authorized by statutory
provisions that govern fund custody arrangements,\1\ and that is not
subject to regulation and examination by U.S. regulators. The
requirement that the fund board determine that it is reasonable to rely
on each delegate is intended to ensure that the board carefully
considers each delegate's qualifications to perform its
responsibilities. The requirement that the delegate provide written
reports to the board is intended to ensure that the delegate notifies
the board of important developments concerning custody arrangements so
that the board may exercise effective oversight. The requirement that
the delegate agree to exercise reasonable care is intended to provide
assurances to the fund that the delegate will properly perform its
duties.
---------------------------------------------------------------------------

    \1\ See section 17(f) of the Act. 15 U.S.C. 80a-17(f).
---------------------------------------------------------------------------

    The requirements that the foreign custody manager determine that
fund assets will be subject to reasonable care with the eligible
foreign custodian and under the custody contract, and that each
contract contain specified provisions or equivalent provisions, are
intended to ensure that the delegate has evaluated the level of care
provided by the custodian, that it weighs the adequacy of contractual
provisions, and that fund assets are protected by minimal contractual
safeguards. The requirement that the foreign custody manager establish
a monitoring system is intended to ensure that the manager periodically
reviews each custody arrangement and takes appropriate action if
developing custody risks may threaten fund assets.\2\
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    \2\ The staff believes that subcustodian monitoring does not
involve ``collection of information'' within the meaning of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501--3520) (``Paperwork
Reduction Act'').
---------------------------------------------------------------------------

    Commission staff estimates that each year, approximately 130
registrants \3\ could be required to make an average of one response
per registrant under rule 17f-5, requiring approximately 2.5 hours of
board of director time per response, to make the necessary findings
concerning foreign custody managers. The total annual burden associated
with these requirements of the rule is up to approximately 325 hours
(130 registrants x 2.5 hours per registrant). The staff further
estimates that during each year, approximately 15 global custodians \4\
are required to make an average of 4 responses per custodian concerning
the use of foreign custodians other than depositories. The staff
estimates that each response will take approximately 270 hours,
requiring approximately 1080 total hours annually per custodian. The
total annual burden associated with these requirements of the rule is
approximately 16,200 hours (15 global custodians x 1080 hours per
custodian). Therefore, the total annual burden of all collection of
information requirements of rule 17f-5 is estimated to be up to 16,525
hours (325 + 16,200). The total annual cost of burden hours is
estimated to be $5,609,200 (325 hours x $4000/hour for board of
director's time, plus 16,200 hours x $266/hour for a trust
administrator's time).\5\ Compliance with the collection of information
requirements of the rule is necessary to obtain the benefit of relying
on the rule's permission for funds to maintain their assets in foreign
custodians.
---------------------------------------------------------------------------

    \3\ This figure is an estimate of the number of new funds each
year, based on data reported by funds in 2012 on Forms N-1A, N-2, N-
4, N-6, and S-6. In practice, not all funds will use foreign custody
managers, and the actual figure may be smaller.
    \4\ This estimate is based on staff research.
    \5\ The board hourly rate is based on fund industry
representations. The $266/hour figure for a trust administrator is
from SIFMA's Management & Professional Earnings in the Securities
Industry 2012, modified by Commission staff to account for an 1800-
hour work-year and multiplied by 5.35 to account for bonuses, firm
size, employee benefits, and overhead.
---------------------------------------------------------------------------

    The estimate of average burden hours is made solely for the
purposes of the Paperwork Reduction Act. The estimate is not derived
from a comprehensive or even a representative survey or study of the
costs of Commission rules and forms.
    Written comments are invited on: (a) Whether the collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information has practical
utility; (b) the accuracy of the Commission's estimate of the burden of
the collection of information; (c) ways to enhance the quality,
utility, and clarity of the information collected; and (d) ways to
minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology. Consideration will be given to
comments and suggestions submitted in writing within 60 days of this
publication.
    Please direct your written comments to Thomas Bayer, Chief
Information Officer, Securities and Exchange Commission, C/O Remi
Pavlik-Simon, 100 F Street NE., Washington, DC 20549; or send an email
to<EMAIL_ADDRESS>
    Dated: December 24, 2013.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2013-31242 Filed 12-30-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 65 (Friday, April 3, 2020)]
[Notices]
[Pages 18949-18950]
[FR Doc No: 2020-07021]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL20-35-000]

Energy Harbor LLC; Notice of Institution of Section 206
Proceeding and Refund Effective Date

    On March 30, 2020, the Commission issued an order in Docket No.
EL20-35-000 pursuant to section 206 of the Federal Power Act (FPA), 16
U.S.C. 824e (2018), instituting an investigation into Energy Harbor
LLC's proposed rejection in bankruptcy of certain contracts that are
subject to the Commission's jurisdiction. Energy Harbor LLC, 170 FERC ]
61,278 (2020).
    The refund effective date in Docket No. EL20-35-000, established
pursuant to section 206(b) of the FPA, will be the date of publication
of this notice in the Federal Register.
    Any interested person desiring to be heard in Docket No. EL20-35-
000 must file a notice of intervention or motion to intervene, as
appropriate, with the Federal Energy Regulatory Commission, 888 First
Street NE, Washington, DC 20426, in accordance with Rule 214 of the
Commission's Rules of Practice and Procedure, 18 CFR 385.214 (2019),
within 21 days of the date of issuance of the order.

    Dated: March 30, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-07021 Filed 4-2-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: December 28, 2005 (Volume 70, Number 248)]
[Notices]
[Page 76811-76812]
[DOCID:fr28de05-102]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Application for Non-Project Use of Project Lands and
Waters and Soliciting Comments, Motions To Intervene, and Protests

December 16, 2005.
    Take notice that the following application has been filed with the
Commission and is available for public inspection:
    a. Application Type: Non-Project Use of Project Lands and Waters.
    b. Project No.: 2145-069.
    c. Date Filed: December 1, 2005.
    d. Applicant: Public Utility District No. 1 of Chelan County.
    e. Name of Project: Rocky Reach Hydroelectric Project.
    f. Location: The proposed action would take place near river mile
493 on the Douglas County (east) shoreline of the project reservoir.
The project is located on the Columbia River in Douglas and Chelan
Counties, Washington.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791 (a) 825(r)
and 799 and 801.
    h. Applicant Contact: Ms. Michelle Smith, Licensing and Compliance
Manager; Public Utility District No. 1 of Chelan County; P.O. Box 1231;
Wenatchee, WA; 98807-1231;<PHONE_NUMBER>, Ext. 4180.
    i. FERC Contact: Any questions on this notice should be addressed
to Isis Johnson at<PHONE_NUMBER>, or by e-mail<EMAIL_ADDRESS>    j. Deadline for filing comments and or motions: January 17, 2006.
    All documents (original and eight copies) should be filed with: Ms.
Magalie R. Salas, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington DC 20426. Please include the project
number (P-2145-069) on any comments or motions filed. Comments,
protests, and interventions may be filed electronically via the
Internet in lieu of paper. See, 18 CFR 385.2001(a)(1)(iii) and the
instructions on the Commission's Web site under the ``e-Filing'' link.
The Commission strongly encourages e-filings.
    k. Description of Request: Public Utility District No. 1 of Chelan
County, licensee for the Rocky Reach Hydroelectric Project, has
requested Commission approval to permit Lake Entiat Lodge Associated
(applicant) to expand the number of docks at the Lake Entiat Estates
Marina (also known as Sun Cove Marina). The existing marina can
accommodate 62 watercrafts, and was built in the mid-1960s within three
small adjoining basins connected to the project reservoir. The
applicant proposes a multi-year development plan designed to improve
the marina for recreational use by the Lake Entiat Estates residential
community. The development plan includes: (1) The installation of 12
new boat slips to accommodate a total of 24 boats; (2) dredging of fine
sediment accumulation within the three existing basins; (3) extending
two existing boat ramps; and (4) the expansion/replacement of certain
existing marina float facilities.
    l. Location of the Application: This filing is available for review
at the Commission or may be viewed on the Commission's Web site at
http://www.ferc.gov, using the ``eLibrary'' link. Enter the docket

number excluding the last three digits in the docket number field to
access the document. For assistance, contact FERC Online Support at
<EMAIL_ADDRESS>or toll-free at<PHONE_NUMBER>, or for TTY,

contact<PHONE_NUMBER>.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit

comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210,
385.211, 385.214. In determining the appropriate action to take, the
Commission will consider all protests or other comments filed, but only
those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any comments,
protests, or motions to intervene must be received on or before the
specified comment date for the particular application.
    o. Filing and Service of Responsive Documents: Any filings must
bear in all capital letters the title ``COMMENTS'', ``RECOMMENDATIONS
FOR TERMS AND CONDITIONS'', ``PROTEST'', or ``MOTION TO INTERVENE'', as
applicable, and the Project Number of the particular application to
which the filing refers. A copy of any motion to intervene must also be
served upon each representative of the Applicant specified in the
particular application.
    p. Agency Comments: Federal, state, and local agencies are invited
to file comments on the described applications. A copy of the
applications may be obtained by agencies directly from the Applicant.
If an agency does not file comments within the time specified for
filing comments, it will be presumed to have no comments. One copy of
an agency's comments must also be sent to the Applicant's
representatives.

Magalie R. Salas,
Secretary.
[FR Doc. E5-7910 Filed 12-27-05; 8:45 am]

BILLING CODE 6717-01-P