[Federal Register Volume 78, Number 208 (Monday, October 28, 2013)]
[Notices]
[Pages 64258-64259]
[FR Doc No: 2013-25293]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-70735; File No. SR-BOX-2013-49]

Self-Regulatory Organizations; BOX Options Exchange LLC; Notice
of Filing and Immediate Effectiveness of a Proposed Rule Change To
Amend the Fee Schedule To Include the Series 56 Examination Fee
Information

October 22, 2013.
    Pursuant to Section 19(b)(1) under the Securities Exchange Act of
1934 (the ``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby
given that on October 16, 2013, BOX Options Exchange LLC (the
``Exchange'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II
and III below, which Items have been prepared by the Exchange. The
Exchange filed the proposed rule change pursuant to 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.
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    \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).
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The Exchange is filing with the Securities and Exchange Commission
(``Commission'') a proposed rule change to amend the Fee Schedule on
the BOX Market LLC (``BOX'') options facility to include the Series 56
examination fee information. The text of the proposed rule change is
available from the principal office of the Exchange, at the
Commission's Public Reference Room and also on the Exchange's Internet
Web site at http://boxexchange.com.

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
    The Exchange recently amended the Fee Schedule for trading on BOX
to establish fees for the Proprietary Trader Program (S501) Continuing
Education Regulatory Element Session.\5\ The Exchange now proposes to
make a clarifying change to specify the fee for the corresponding
Proprietary Trader Qualification Examination (``Series 56'') on the Fee
Schedule.
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    \5\ See Securities Exchange Act Release No. 70255 (August 26,
2013), 78 FR 53812 (August 30, 2013) (Notice of Filing and Immediate
Effectiveness of SR-BOX-2013-42).
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    Specifically, the Exchange proposes to add the $195.00 fee per
person, per Series 56 examination to the Fee Schedule. This fee
reflects both the cost of the examination and the costs incurred in
maintaining and developing the examination and continuing education
program to ensure their content is and continues to be adequate in
testing the competence and knowledge generally applicable to
proprietary trading. The $60.00 per person, per session fee for the
S501 continuing education requirement is already contained within the
Fee Schedule and the Exchange believes including both fees in the Fee
Schedule would clarify the full cost of the exam to Participants. The
Series 56 examination is administered by the Financial Industry
Regulatory Authority (``FINRA'') on behalf of the Exchange.\6\
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    \6\ Participants would continue to submit the exam fee, as well
as the fee for continuing education, to FINRA; the Exchange will not
invoice or collect these fees.
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    The Exchange permits each person associated with a Participant who
is included within the definition of Representative to register as a
Limited Representative--Proprietary Trader if his activities in the
investment banking or securities business are limited solely to
proprietary trading; and he passes the appropriate Qualification
Examination for Limited Representative--Proprietary Trader, the Series
56; and he is an associated person of a proprietary trading firm.\7\
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    \7\ See Exchange Rule 2020(b)(2)(i). Under Exchange Rule
2020(e)(2) a proprietary trading firm is a Participant that trades
its own capital, that does not have customers, and that is not a
member of the Financial Industry Regulatory Authority. In addition,
to qualify for this definition, the funds used by a proprietary
trading firm must be exclusively firm funds, all trading must be in
the firm's accounts, and traders must be owners of, employees of, or
contractors to the firm.
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    The Exchange's Fee Schedule does not currently set forth the fees
applicable for the Series 7 and its continuing education program (S101)
as these programs are within FINRA's jurisdiction and collected by
FINRA from its members. On the contrary, the Series 56 and its
continuing education requirements apply to Participants that are not
required by Section 15(b)(8) of the Act \8\ to become a FINRA member.
Therefore, the Exchange believes including these fees in the Fee
Schedule will clarify the costs related to this exam and its continuing
education.
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    \8\ 15 U.S.C. 78o(b)(8).
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    Additionally, the Exchange proposes to make clarifying changes to
the fee schedule to make certain that the differences between these two
related fees, the Series 56 examination fee and the S501 continuing
education fee, are clear.
2. Statutory Basis
    The Exchange believes that the proposal is consistent with the
requirements of Section 6(b) of the Act, in general, and Section
6(b)(4) and 6(b)(5)of the Act,\9\ in particular, in that it provides
for the equitable allocation of reasonable dues, fees, and other
charges among BOX Participants and other persons using its facilities
and does not unfairly discriminate between customers, issuers, brokers
or dealers.
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    \9\ 15 U.S.C. 78f(b)(4) and (5).
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    The Exchange is proposing to include additional information about a
relevant fee for the sake of clarity. On behalf of the exchanges, FINRA
incurs costs in maintaining and developing the examination and
continuing education program to ensure their content is and continues
to be adequate in testing the competence and knowledge generally
applicable to proprietary trading. The Exchange believes the Series 56
examination fee is reasonable as it is designed to allow FINRA to cover
its cost of administering the Series 56 exam program on behalf of the
Exchange. The fee for the Series 56 exam is greater than the fee for
continuing education because the exam fee is also designed to cover the
costs associated with developing not just the Series 56 exam, but also
the related S501 continuing education program. The Exchange also
believes this fee is reasonable because it understands that other
exchanges will be assessing an identical fee to be collected by FINRA
for the Series 56 exam. In addition, the Exchange believes this fee is
equitably allocated and not unfairly discriminatory as it will apply
uniformly to all Participants

who chose to take the Series 56 examination.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. The proposed change is designed
to provide greater specificity and clarity within the Fee Schedule with
respect to the fees related to the Series 56 exam and does not impose
any burden on intermarket competition because other exchanges will be
assessing an identical fee for the Series 56 exam.

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 Effectiveness

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Exchange Act \10\ and Rule 19b-4(f)(2)
thereunder,\11\ because it establishes or changes a due, or fee.
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    \10\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \11\ 17 CFR 240.19b-4(f)(2).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend the rule
change if it appears to the Commission that the action is necessary or
appropriate in the public interest, for the protection of investors, or
would otherwise further the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

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-BOX-2013-49 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-BOX-2013-49. 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
10:00 a.m. and 3:00 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 available publicly. All
submissions should refer to File Number SR-BOX-2013-49 and should be
submitted on or before November 18, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
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    \12\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-25293 Filed 10-25-13; 8:45 am]
BILLING CODE 8011-01-P


Human Health Risk Assessment Overview Michael S. Metzger Michael S. Metzger U. S. EPA U. S. EPA Office of Pesticide Programs Office of Pesticide Programs ( 703) 305 ( 703) 305 5883 5883 Metzger. michael@ epa. gov Metzger. michael@ epa. gov April 4, 2006 April 4, 2006 2 Risk Assessment Paradigm Risk Assessment Paradigm Hazard Identification Dose Response Assessment Exposure Assessment Risk Characterization * From the National Research Council's Risk Assessment in the Federal Government: Managing the Process, 1983. 3 Hazard Assessment: Hazard vs. Risk Hazard Assessment: Hazard vs. Risk

Risk = f ( hazard, exposure)

Hazard = Toxicity 4 Standard Guideline Toxicity Study Requirements Standard Guideline Toxicity Study Requirements   Acute toxicity battery   Subchronic oral toxicity in rats   Subchronic dermal toxicity in rats and rabbits   Subchronic inhalation toxicity in rats   Developmental toxicity in rats and rabbits   2 Generation reproduction in rats   Chronic / carcinogenicity in rats, dogs, and mice   Acute ( ACN) and subchronic ( SCN) neurotoxicity in rats   Delayed neurotoxicity in hens   Mutagenicity testing battery ( in vitro)

  Developmental neurotoxicity ( DNT) in rats   Dermal absorption   Rat metabolism 5 Hazard Characterization Hazard Characterization

Important toxicological effects including developmental /

fetal, reproductive, endocrine, carcinogenic, and others

Any critical exposure periods and routes

Metabolism and potential for bioaccumulation

Quality of the data and uncertainties

Toxicity data available for related chemicals

Pertinence of the observed toxicity to humans

Availability of related epidemiological data

Toxic mode of action information 6 Dose Dose response Assessment and Endpoint response Assessment and Endpoint Selection: Definitions Selection: Definitions

Point of Departure ( POD): Any dose level used to quantify risk ( generic)

Endpoint: Toxic Effect upon which the risk assessment is based

Lowest Observed Adverse Effect Level ( LOAEL):

Lowest dose from a study at which adverse toxic effects were observed

No Observed Adverse Effect Level ( NOAEL): The dose below the LOAEL at which no adverse toxic effects are observed 7 Benchmark Dose ( BMD) Approach Benchmark Dose ( BMD) Approach BMD: The dose associated with a specified measure or change of a biological effect, generally in the range of 1% to 10%.

BMDL: A lower one sided confidence limit on the BMD.

  Uses all data points from one or more toxicity studies to statistically derive a dose response curve   Improved estimate of the dose response relative to using NOAELs/ LOAELs  POD less dependent on dose spacing   Used for some single chemical, and all cumulative risk assessments 8 Dose Dose response Assessment and Endpoint Selection response Assessment and Endpoint Selection Endpoints selected for risk assessment must be the most sensitive endpoint for each population,

and relevant to humans.

Most sensitive ( protective)   Most protective POD ( e. g. lowest NOAEL, highest q*)

Relevant   Toxicity seen in animal studies could also occur in humans 9

3 Major routes: oral, dermal, inhalation

Toxic effects seen and severity of toxic effects can vary by route  Of particular concern for portal of entry effects

Must assure that route of dosing in animal study matches human exposure route   or characterize any mismatch Dose Dose response Assessment and Endpoint Selection:

response Assessment and Endpoint Selection:

Route Route 10 Dose Dose response Assessment and Endpoint Selection:

response Assessment and Endpoint Selection:

Duration Duration Chemical specific Cancer 6 months  lifetime Chronic 1 6 months Intermediate term ( IT) 1 30 days Short term ( ST) 1 day Acute Duration of Continuous Exposure Scenario 11 Uncertainty and Safety Factors Uncertainty and Safety Factors ° " One of several, generally 10 fold factors, used in operationally deriving the RfD and RfC from experimental data" ( http:// www. epa. gov/ iris/ gloss8. htm)

° Intraspecies   variability among humans ° Interspecies   extrapolating animal data to humans ° Extrapolating from less than lifetime to lifetime exposures ° LOAEL to NOAEL ° Incomplete data base ° FQPA 12 Expressing Risks Expressing Risks % Reference Dose (% RfD):

RfD = NOAEL UFs ( all except FQPA SF)

% RfD = Exposure x 100 RfD Margin of Exposure ( MOE)

MOE = NOAEL Exposure 13 Expressing Risks Expressing Risks % PAD = Exposure x 100 PAD % Population Adjusted Dose (% PAD):

PAD = NOAEL UFs ( all including FQPA SF) 14 Aggregate Risk Assessment Aggregate Risk Assessment Aggregate risk includes combined exposure from:

 Food  Drinking water  Other non occupational exposures ( e. g.

residential, playing golf)

Aggregate assessments done for all durations of exposure Oral, dermal and inhalation routes aggregated if common toxic effects are expected from the different routes 15 Cumulative Risk Assessment Cumulative Risk Assessment Total risk aggregated for:

all potential exposure scenarios

all routes of exposure

across chemicals which have a common mechanism endpoint Chemical A

Chemical B

Chemical C  Food, drinking water,

residential exp Food, drinking water,

residential exp Food, drinking water,

residential exp Cumulative Risk } 16 Cumulative Risk Assessment Cumulative Risk Assessment

Uses the BMD approach

Utilizes Relative Potency Factors ( RPFs; index chemical = 1) which correct exposure estimates for comparison to a common POD  POD for index chemical which has highest quality toxicity data base among chemicals in Common Mechanism Group ( CMG)

http:// www. epa. gov/ oppfead1/ trac/ science/# common 17 Questions