1 DRAFT November 26, 2003 FIFRA SCIENTIFIC ADVISORY PANEL ( SAP) OPEN MEETING DECEMBER 3 5, 2003 FIFRA SAP WEB SITE http:// www. epa. gov/ scipoly/ sap/ OPP Docket Telephone: ( 703) 305 5805 Docket Number: OPP 2003 0316 WEDNESDAY, DECEMBER 3, 2003 SHERATON CRYSTAL CITY HOTEL 1800 JEFFERSON DAVIS HIGHWAY ARLINGTON, VIRGINIA 22202 703 486 1111 Draft Preliminary Probabilistic Exposure and Risk Assessment for Children Who Contact CCA Treated Wood on Playsets and Decks and CCA Containing Soil Around These Structures

8: 30 AM Introduction and Identification of Panel Members  Steven Heeringa, Ph. D. ( FIFRA SAP Session Chair)

8: 45 AM Administrative Procedures by Designated Federal Official  Mr. Paul Lewis

8: 50 AM Welcome  Mr. Joseph J. Merenda ( Director, Office of Science Coordination and Policy, EPA)

8: 55 AM Opening Remarks  Mr. William Jordan ( Office of Pesticide Programs, EPA)

9: 00 AM Introduction, Goals and Objectives of the Session  Mr. William Jordan ( Office of Pesticide Programs, EPA)

9: 10 AM Introduction of the SHEDS Wood Model Assessment for CCA  Halûk Özkaynak, Ph. D. ( Office of Research and Development, EPA)

9: 20 AM Summary of SHEDS Wood Model Methodology and Inputs for the CCA Exposure Assessment  Valerie Zartarian, Ph. D. ( Office of Research and Development, EPA), Jianping Xue, MD, MPH ( Office of Research and Development, EPA), Graham Glen, Ph. D ( ManTech Environmental Technology, Inc.), and Halûk Özkaynak, Ph. D. ( Office of Research and Development, EPA)

10: 15 AM BREAK

10: 45 AM Presentation of SHEDS Wood ADD and LADD Results for CCA Assessment, Including Variability, Sensitivity, and Uncertainty Analysis Results  Valerie Zartarian, Ph. D. ( Office of Research and Development, EPA), Jianping Xue, MD, MPH ( Office of Research and Development, EPA), Graham Glen, Ph. D. 2 ( ManTech Environmental Technology, Inc.), and Halûk Özkaynak, Ph. D. ( Office of Research and Development, EPA)

11: 45 AM Strengths and Limitations of Probabilistic Exposure and Dose Assessment  Halûk Özkaynak, Ph. D. ( Office of Research and Development, EPA)

12: 15 PM LUNCH

1: 15 PM Introduction, Goals and Objectives of the Probabilistic CCA Risk Assessment  Winston Dang, Ph. D. MPH ( Office of Pesticide Programs, EPA)

1: 30 PM CCA Risk Analysis and Results  Winston Dang, Ph. D. MPH ( Office of Pesticide Programs, EPA)

2: 30 PM BREAK

2: 45 PM Strengths and Limitations of Probabilistic Risk Assessment  Winston Dang, Ph. D, MPH ( Office of Pesticide Programs, EPA)

3: 30 PM Public Comments

4: 30 PM ADJOURNMENT 3 THURSDAY, DECEMBER 4, 2003 SHERATON CRYSTAL CITY HOTEL 1800 JEFFERSON DAVIS HIGHWAY ARLINGTON, VIRGINIA 22202 703 486 1111

8: 30 AM Introduction  Steven Heeringa, Ph. D. ( FIFRA SAP Session Chair)

8: 40 AM Administrative procedures by Designated Federal Official  Mr. Paul Lewis

8: 45 AM Follow up from Previous Day's Discussion  Mr. William Jordan ( Office of Pesticide Programs, EPA)

9: 00 AM Public Comments ( continued)

10: 30 AM BREAK

10: 45 AM Public Comments

12: 00 PM LUNCH

1: 00 PM Panel Discussion Issue 1: Documentation, completeness, and clarity of the model source code and the exposure assessment report Both the SHEDS Wood source code and the probabilistic exposure assessment report have been significantly revised since the August 2002 SAP.

Question A: The Source Code Directory on the CD provided to the SAP includes annotated code for the exposure and dose algorithms used in the SHEDS Wood model. Are these algorithms consistent with the descriptions in the SHEDS Wood CCA exposure assessment report? Does the revised SHEDS Wood version 2 code ( i. e., the code submitted for the December 2003 SAP) accurately reflect changes to the version 1 methodology ( i. e., the code and methodology presented to the August 2002 SAP) described in the report?

Question B: The SHEDS Wood CCA exposure assessment report presents the model construct, selected model inputs, model results, and comparison to other CCA model estimates. Please comment on the clarity, completeness and usefulness of this document.

Lead Discussant: Peter Macdonald, D. Phil Associate Discussants: Barry Ryan, Ph. D. and Dale Hattis, Ph. D.

Issue 2. Modifications to SHEDS Wood model code and the exposure scenarios selected A number of modifications to the model code and scenario specific changes have been made to the SHEDS Wood model since the August 2002 SAP. 4 Question A: Considering the limitations of available information and state of the art modeling methods required for the assessment of children's exposures from contacting CCA treated wood residues and CCA containing soil, are the revisions made to the SHEDS Wood code or algorithms scientifically sound and acceptable ?

Question B: The SHEDS Wood model has been modified using feedback from the August 2002 SAP. In particular, the recent assessment, includes: assessment of exposures of children contacting only CCA treated public playsets; sensitivity of results to changing the age group of exposed children to 1 13 years, and; a separate analysis for children exhibiting pica soil ingestion behavior. The Panel is requested to comment on the appropriateness of the new exposure scenarios in the revised probabilistic exposure and dose assessment.

Lead Discussant: Kenneth Portier, Ph. D. Associate Discussants: David MacIntosh, Ph. D. and Natalie Freeman, Ph. D.

3: 00 PM BREAK

3: 15 PM Panel Discussion ( continued)

Issue 3. Key input variables and specification of associated variability distributions Sensitivity and uncertainty analyses of the SHEDS Wood model results identified the following as key input variables influencing the model results: wood surface residue to skin transfer efficiency; wood surface residue levels; fraction of hand surface area mouthed per mouthing event; and GI absorption fraction for residues. In addition to the above variables, sensitivity and uncertainty analyses also indicated the importance of following additional variables: average number of days per year a child plays around CCA treated playsets, frequency of hand washing, daily soil ingestion rate, and average fraction of non residential time a child plays on/ around CCA treated playsets.

Question A. Has the Agency used the best available information for developing input distributions for these variables? If not, are there any other data that EPA should be aware of? Considering the limitations and uncertainties with available information, are the choices made in developing distributions for each of these key variables using the available information reasonable and scientifically sound?

Question B. In some of these instances ( see Table 12, page 58), because of data limitations, the Agency has made simplifying assumptions to represent them as point estimates based on professional judgement. Are the simplifying assumptions presented in the draft exposure assessment for making these decisions adequately supported by relevant scientific data? Are the choices made to quantify these variables ( i. e., selected distributions or point estimates) reasonable and sound? 5 Question C. Are the methods used for fitting variability distributions that are assigned to model input variables for the CCA assessment appropriate?

Question D. The Panel is requested to comment on whether any other model inputs are either key drivers of results or sources of large model uncertainty. Do these model input variables and the distributions assigned to them appropriately reflect available scientific data ? Did EPA appropriately integrate the available data to derive the distributions for these input variables?

Lead Discussant: John Adgate, Ph. D. Associate Discussants: John Kissel, Ph. D., Marcie Francis, Ph. D., and Nu May Ruby Reed, Ph. D Issue 4: Methods and results for sensitivity and uncertainty analyses EPA's draft CCA Exposure Assessment includes a formal sensitivity and uncertainty analysis as well as discussion of various sources of uncertainty in the model analyses.

Question A: The Panel is requested to comment on the utility and suitability of the statistical diagnostic tools used by SHEDS for analyzing model results ( e. g., variability analyses, sensitivity analyses, uncertainty analyses).

Question B: Is the bootstrap approach that is used for fitting uncertainty distributions, which has been revised in response to prior SAP comments, implemented properly, or are there alternative approaches that are recommended?

Question C: Are the uncertainty distributions assigned to chemical and non chemical specific model input parameters appropriate?

Question D: The Panel is requested to comment on whether the modeling approach and documentation appropriately identify and address critical sources of uncertainty in the model and the resulting exposure estimates. Does EPA's documentation adequately describe the uncertainties inherent in the data used for modeling and the influence of these uncertainties on interpretation of the modeling results?

Question E. Does the Panel recommend performing any additional uncertainty analyses to evaluate the impacts of using alternative input distributions on the modeling results ( e. g., to address uncertainties in various factors determining the frequency of children's exposures to CCAtreated wood in playsets and decks)?

Lead Discussant: David MacIntosh, Ph. D. Associate Discussants: Barry Ryan, Ph. D., Marcie Francis, Ph. D., Dale Hattis, and Kenneth Portier, Ph. D. 6

5: 30 PM ADJOURNMENT 7 FRIDAY, DECEMBER 5, 2003 SHERATON CRYSTAL CITY HOTEL 1800 JEFFERSON DAVIS HIGHWAY ARLINGTON, VIRGINIA 22202 703 486 1111

8: 30 AM Introduction  Steven Heeringa, Ph. D. ( FIFRA SAP Session Chair)

8: 40 AM Administrative procedures by Designated Federal Official  Mr. Paul Lewis

8: 45 AM Follow up from Previous Day's Discussion  Mr. William Jordan ( Office of Pesticide Programs, EPA)

9: 00 AM Panel Discussion ( continued)

Issue 5: Special Model Simulations A number of special simulations with the SHEDS Wood model were conducted in order to examine the importance of specific exposure scenarios or the impact of certain input assumptions. For example, some of these analyses included conducting separate simulations for children exposed to public playsets only, modeling exposures of the 7 13 year old age group, and studying exposures of children exhibiting pica behavior. Additional analyses were also conducted to examine the impacts of using data or assumptions about increased GI absorption, decreased dermal absorption, lowering the transferable wood residue concentrations by sealants, and hand washing after play events. The results from these special analyses were not significantly different than the baseline model results, except for the large impact of assuming the use of sealants would greatly reduce wood residues.

Question A. The Panel is requested to comment on the appropriateness of the justifications made in characterizing the key factors or inputs for each of these special simulations. Did the Agency provide adequate technical rationale and justification for its choices for these alternative exposure scenarios or input distributions? Do the results from these special analyses reflect proper use of available information?

Question B: Do any of the findings from these special analyses necessitate the Agency to consider revising certain scenarios or inputs to the baseline assessment?

Lead Discussant: John Kissel, Ph. D. Associate Discussants: Natalie Freeman, Ph. D., David Stilwell, Ph. D. and Dale Hattis, Ph. D.

Issue 6: Evaluation of the SHEDS Wood model results The Agency has evaluated the probabilistic CCA exposure model results by comparing them to results from other earlier deterministic CCA assessments. In particular, the SHEDS Wood model results were found to compare well to a deterministic CCA assessment performed by the Gradient 8 Corporation, and SHEDS Wood upper percentiles compare well to deterministic Consumer Product Safety Commission estimates.

Question A: Has EPA provided adequate documentation of the overall plausibility of the exposure estimates generated by the SHEDS Wood model for CCA? Are the comparisons with the results of other selected exposure assessments appropriate and appropriately presented? Are there any other types of benchmarking approaches or data to assess the reliability of the overall exposure model or specific model elements?

Lead Discussant: Nu May Ruby Reed, Ph. D. Associate Discussants: Natalie Freeman, Ph. D. and Barry Ryan, Ph. D.

Issue 7: Overall completeness and acceptability of the SHEDS Wood probabilistic CCA exposure assessment EPA has revised the August 2002 SHEDS Wood exposure assessment after carefully considering numerous comments and suggestions that it has received from various parties, including those from the August 2002 FIFRA SAP members, EPA/ ORD and EPA Program Office peer reviewers of the preliminary draft September 2003 report, and from the general public and other external groups.

Question A: In addition to the comments and suggestions already offered by the Panel members under the specific issues raised previously, considering the availability of data and information, does the Panel recognize any critical gaps in information or methodologies that still need to be addressed for the CCA exposure and dose assessment?

Lead Discussant: Dale Hattis, Ph. D. Associate Discussants: Marcie Francis, Ph. D. and Stan Lebow, Ph. D.

10: 30 AM BREAK

10: 45 AM Panel Discussion ( continued)

Issue 8: In the study by Nico et al. ( 2003), X ray absorption spectroscopy ( XAS) was used to determine the chemical and structural state of arsenic and chromium molecules in CCA treated wood residue samples. Based on the results of their analysis, Nico et al. ( 2003) determined that arsenic and chromium formed a " chemical complex bonded to the wood structure." Based on this study, the dominant oxidation state of the two elements is As( V) and Cr( III), and the local chemical environment of the two elements is best represented as a stable Cr/ As cluster consisting of a Cr dimer bridged by an As( V) oxygen ion. Nico et al. ( 2003) also maintained that this chemical complex was quite resistant to leaching.

Question A: The Panel is requested to comment on the Nico et. al. ( 2003) study and particularly on the arsenic and chromium chemical complex from CCA treated wood surface residue, and whether the Panel believes that the chemical complex is 9 formed during the fixation process. What is the meaning of this complex cluster formation to the current risk assessment Lead Discussant: Donald Wauchope, Ph. D. Associate Discussants: Stan Lebow, Ph. D., Michael Bates, Ph. D. Marcie Francis, Ph. D. and David Stilwell, Ph. D.

Issue 9. Casteel et al. ( 2003), reported that the relative bioavailability ( RBA) of dislodgeable wood residue is 27%. This value is significantly lower than the default value of 100% that is usually employed when reliable site specific data are lacking and also lower than the RBA value recommended by the SAP 2001. The result of this study indicates that the arsenic in the dislodgeable arsenic material is not as well absorbed as soluble arsenic.

Question A: Does the Panel agree that, in light of the Casteel study and the Nico study discussed in issue 8, the Agency should use 27% for the RBA to estimate the bioavailable dose.

Lead Discussant: Donald Wauchope, Ph. D. Associate Discussants: Stan Lebow, Ph. D. , David Stilwell, Ph. D. and Miroslav Styblo, Ph. D.

12: 00 PM LUNCH

1: 00 PM Panel Discussion ( continued)

Issue 10: In the 2001 SAP meeting, the Panel cited the research of Wester et al. ( 1993) as a source of the dermal absorption rate of soluble arsenic in water and soil. The Panel recommended using a 2 3 % dermal absorption rate for arsenic residue on the surface of wood. Recently, a preliminary study by Wester et al. ( 2003) has been submitted by the same laboratory compares the dermal absorption of arsenic in CCA treated wood surface residues with arsenic in water solution. Although the Agency has not receive the complete results of this study ( e. g., the recovery of the arsenic in the urine of the animal given IV dose of arsenic), the preliminary results of this study indicate that the dermal absorption of 0.01% from wood surface residue was approximately two order of magnitude lower than the results in water. The dermal absorption from this study was based on urinary arsenic data following application of arsenic in CCA treated wood residue that had been weathered by the environment.

Question A: Taking into consideration the Nico et al. study mentioned in issue 8, the Panel is requested to comment on whether this new study conducted by Wester et al. provides a more appropriate estimate of dermal absorption from contact with CCA treated wood surfaces than the earlier 1993 Wester et al. study.

Lead Discussant: John Kissel, Ph. D. Associate Discussants: Jim Riviere, DVM, Ph. D. and Michael Bates, Ph. D. 10 Issue 11: In the 2001 SAP meeting, the Panel recommended that a biomonitoring study be performed on children who are normally exposed to CCA treated playground equipment and decks. The Panel recommended that the study should be designed according to well accepted epidemiological principles, including adequate sample size, to resolve the issue of whether there are substantial exposures to children from arsenic residues after playing on decks and playsets. The Panel indicated data from such a biomonitoring study could be directly used in the risk assessment and could be used to validate the exposure assessment model. Recently, a proposed protocol for a pilot study was submitted to OPP for peer review; this proposed protocol is an attempt to determine if changes in exposure to arsenic can be assessed by examining changes in the urinary excretion of arsenic. EPA has provided the Panel with a copy of the proposed protocol for the pilot study. In summary, the proposed pilot study will determine whether a significant difference in urinary arsenic can be discerned when a population of children are switched from arsenic containing tap water to an essentially arsenic free source of drinking water.

Question A. The Panel is requested to comment on the strengths and limitations of the approach to be employed in the proposed pilot study to help resolve the issue of whether there are substantial exposures to children from arsenic residues after playing on decks and playsets. In particular, please comment on the feasibility, the potential confounding background sources from the statistical analysis, the sensitivity and accuracy of analytical method for quantitation of arsenic in urine to detect changes, the determination of intraindividual variation and interindividual variation based on the current knowledge of exposure; and any other aspects of the proposed pilot study that might affect its utility.

Question B. The Panel is asked to describe approaches for gathering additional data   e. g., data on the efficiency of transfer of surface residues to the skin surface ( which has been identified as one of most critical model inputs based on the uncertainty analysis)   to improve the estimates of exposure and / or the level of confidence in such estimates, and with respect to these approaches, as well as the proposed pilot study, to comment on the cost of data generation, the amount of time to generate the data, and the degree to which the data will reduce uncertainty about the accuracy of the model estimates.

Lead Discussant: Barry Ryan, Ph. D. Associate Discussant: Jacob Steinberg, M. D., Michael Bates, Ph. D., and Miroslav Styblo, Ph. D.

Issue 12. Prior to the availability of probabilistic models, such as SHEDS, OPP estimated the lifetime average daily dose ( LADD) and corresponding cancer risk to pesticides via a deterministic approach using central tendency input parameters ( median or mean values). Probabilistic models now allow OPP to express input parameters as distributions and subsequently generate a distribution of LADDs and corresponding pesticide cancer risks. In other words, the deterministic approach results in a single cancer risk value and the probabilistic approach results in a distribution of cancer risk values. 11 Question A. The Panel is requested to comment on whether in this probabilistic approach of using the upper bound arsenic cancer slope factor combined with using high end LADDs would result in a significant overestimation of the risk for the more highly exposed percentiles of the population ? If this is an overestimate, what other values would the panel recommended using as replacements, or in addition to the values that were used that would minimize the overestimation of risk without substantially underestimating the risk for such percentiles.

In this assessment, the estimated risks are considered approximations because inaccuracies may occur when exposures are summed across routes at the quartile level especially in the upper percentile. This is due to the way the Monte Carlo simulations were conducted and the outputs summarized.

Question B. The Panel is requested to comment on the range of percentiles, if any, at which there is a significant decrease in the reliability of the estimates of risk.

Lead Discussant: Dale Hattis, Ph. D. Associate Discussants: Peter Macdonald, D. Phil., Kenneth Portier, Ph. D. and Chi Hsin Selene Jen Chou, Ph. D.

4: 00 PM ADJOURNMENT Please be advised that agenda times are approximate. For further information, please contact the Designated Federal Official for this meeting, Mr. Paul Lewis, via telephone: ( 202) 564 8450; fax: ( 202) 564 8382; or email: lewis. paul@ epa. gov


[Federal Register: May 7, 2007 (Volume 72, Number 87)]
[Notices]
[Page 25795-25799]
[DOCID:fr07my07-89]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 27812; 812-13340]

First Trust Exchange-Traded Fund, et al.; Notice of Application

April 30, 2007.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice of an application for an order under section 12(d)(1)(J)
of the Investment Company Act of 1940 (the ``Act'') for exemption from
sections 12(d)(1)(A) and (B) of the Act and under sections 6(c) and
17(b) of the Act for an exemption from section 17(a) of the Act.

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Summary of the Application: The applicants request an order to permit
certain management investment companies and unit investment trusts
registered under the Act to acquire shares of certain open-end
management investment companies registered under the Act that are
outside the same group of investment companies.

Applicants: First Trust Exchange-Traded Fund (``Initial Trust''), First
Trust Exchange-Traded Fund II (``Trust II''), and First Trust Exchange-
Traded AlphaDEX Fund (``AlphaDEX Trust'') (collectively, the ``Existing
Trusts''), First Trust Advisors L.P. (the ``Advisor'') and First Trust
Portfolios L.P. (the ``Distributor'').

Filing Dates: The application was filed on November 7, 2006, and
amended on April 27, 2007.

Hearing or Notification of Hearing: An order granting the application
will be issued unless the Commission orders a hearing. Interested
persons may request a hearing by writing to the Commission's Secretary
and serving applicants with a copy of the request, personally or by
mail. Hearing requests should be received by the Commission by 5:30
p.m. on May 29, 2007, and should be accompanied by proof of service on
applicants, in the form of an affidavit or, for lawyers, a certificate
of service. Hearing requests should state the nature of the writer's
interest, the reason for the request, and the issues contested. Persons
who wish to be notified of a hearing may request notification by
writing to the Commission's Secretary.

ADDRESSES: Secretary, U.S. Securities and Exchange Commission, 100 F
Street, NE., Washington, DC 20549-1090; Applicants, 1001 Warrenville
Road, Lisle, Illinois 60532.

FOR FURTHER INFORMATION CONTACT: Barbara T. Heussler, Senior Counsel,
at<PHONE_NUMBER>, or Mary Kay Frech, Branch Chief, at<PHONE_NUMBER>
(Division of Investment Management, Office of Investment Company
Regulation).

SUPPLEMENTARY INFORMATION: The following is a summary of the
application. The complete application may be obtained for a fee at the
Public Reference Desk, U.S. Securities and Exchange Commission, 100 F
Street, NE., Washington DC 20549-0102 (telephone<PHONE_NUMBER>).

Applicants' Representations

    1. The Existing Trusts, Massachusetts business trusts, are each an
open-end

management investment company registered under the Act and organized as
a series fund.\1\ The Initial Trust currently has twelve series. Trust
II and the AlphaDEX Trust currently do not have series. The Existing
Trusts and their series operate as exchange-traded funds that redeem
their shares in large aggregations (``Creation Units'') in reliance on
an order previously granted by the Commission (``ETF Order'').\2\ The
Advisor is registered as an investment adviser under the Investment
Advisers Act of 1940 (``Advisers Act''). The Advisor or an entity
controlling, controlled by or under common control with the Advisor
will serve as investment adviser to the Index Funds. The Advisor may
enter into sub-advisory agreements with sub-advisors with respect to
particular Index Funds (each, a ``Sub-Advisor''). The Distributor is
registered as a broker-dealer under the Securities Exchange Act of
1934.
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    \1\Applicants request that the order also extend to any other
existing and future series of the Existing Trusts and any other
registered open-end management investment companies and their series
that may be created in the future and are part of the same group of
investment companies within the meaning of section 12(d)(1)(G)(ii)
of the Act, as the Existing Trusts (together with the Existing
Trusts, if they have no series, and any series of an Existing Trust,
the ``Index Funds'').
    \2\In the matter of First Trust Exchange-Traded Fund, et al.,
Investment Company Act Release Nos. 27051 (August 26, 2005) (notice)
and 27068 (September 20, 2005) (order).
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    2. Applicants request relief to: (a) Permit management investment
companies or series thereof (``Investing Management Companies'') and
unit investment trusts or series thereof (``Investing Trusts'' and,
together with Investing Management Companies, ``Investing Funds'')
registered under the Act, that are not part of the same group of
investment companies as an Index Fund within the meaning of section
12(d)(1)(G)(ii) of the Act, to acquire, and such Index Fund to sell,
shares of such Index Fund beyond the limits of sections 12(d)(1)(A) and
(B) of the Act; (b) permit principal underwriters, and any other
brokers or dealers (``Brokers'') to sell shares of any Index Fund to an
Investing Fund in excess of the limits prescribed by section
12(d)(1)(B) of the Act; and (c) exempt such transactions from section
17(a) of the Act.\3\
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    \3\All Index Funds that currently intend to rely on the
requested order are named as applicants. Any other entity that
relies on the order in the future will comply with the terms and
conditions of the application. An Investing Fund may rely on the
requested order only to invest in the Index Funds and not in any
other registered investment company.
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    3. Each Investing Management Company will be advised by an
investment adviser within the meaning of section 2(a)(20)(A) of the Act
(``Investing Fund Adviser'') and may be advised by one or more
investment advisers within the meaning of section 2(a)(20)(B) of the
Act (each an ``Investing Fund Subadviser''). Any Investing Fund Adviser
or Investing Fund Subadviser will be registered as an investment
adviser under the Advisers Act. Each Investing Trust will be sponsored
by a sponsor (``Sponsor'').
    4. Applicants state that the Index Funds will offer the Investing
Funds simple and efficient vehicles to achieve their asset allocation
or diversification objectives. Applicants state that the Index Funds
will also provide high quality and low cost professional investment
program alternatives to Investing Funds that do not have sufficient
assets to operate a comparable fund.

Applicants' Legal Analysis

A. Section 12(d)(1)

    1. Section 12(d)(1)(A) of the Act, in relevant part, prohibits a
registered investment company from acquiring shares of an investment
company if the securities represent more than 3% of the total
outstanding voting stock of the acquired company, more than 5% of the
total assets of the acquiring company, or, together with the securities
of any other investment companies, more than 10% of the total assets of
the acquiring company. Section 12(d)(1)(B) of the Act prohibits a
registered open-end investment company, its principal underwriter, and
any broker or dealer from selling its shares to another investment
company if the sale will cause the acquiring company to own more than
3% of the acquired company's voting stock, or if the sale will cause
more than 10% of the acquired company's voting stock to be owned by
investment companies generally.
    2. Section 12(d)(1)(J) of the Act provides that the Commission may
exempt any person, security, or transaction, or any class or classes of
persons, securities or transactions, from any provision of section
12(d)(1) if the exemption is consistent with the public interest and
the protection of investors. Applicants seek an exemption under section
12(d)(1)(J) of the Act to permit Investing Funds to acquire shares of
the Index Funds in excess of the limits in section 12(d)(1)(A) of the
Act, and an Index Fund, any principal underwriter for an Index Fund and
any Broker to sell shares of an Index Fund to an Investing Fund in
excess of the limits of section 12(d)(1)(B) of the Act.
    3. Applicants state that the proposed arrangement and conditions
will adequately address the policy concerns underlying sections
12(d)(1)(A) and (B) of the Act, which include concerns about large
scale redemptions of the acquired fund's shares, excessive layering of
fees, and overly complex fund structures. Accordingly, applicants
believe that the requested exemption is consistent with the public
interest and the protection of investors.
    4. Applicants believe that neither the Investing Fund nor an
Investing Fund Affiliate would be able to exert undue influence over
the Index Funds.\4\ To limit the control that an Investing Fund may
have over an Index Fund, applicants propose a condition prohibiting the
Investing Fund Adviser or Sponsor, any person controlling, controlled
by, or under common control with the Investing Fund Adviser or Sponsor,
and any investment company and any issuer that would be an investment
company but for sections 3(c)(1) or 3(c)(7) of the Act that is advised
or sponsored by the Investing Fund Adviser or Sponsor, or any person
controlling, controlled by, or under common control with the Investing
Fund Adviser or Sponsor (``Investing Fund Adviser/ Sponsor Group'')
from controlling (individually or in the aggregate) an Index Fund
within the meaning of section 2(a)(9) of the Act. The same prohibition
would apply to any Investing Fund Subadviser, any person controlling,
controlled by or under common control with the Investing Fund
Subadviser, and any investment company or issuer that would be an
investment company but for section 3(c)(1) or 3(c)(7) of the Act (or
portion of such investment company or issuer) advised or sponsored by
the Investing Fund Subadviser or any person controlling, controlled by
or under common control with the Investing Fund Subadviser
(``Subadviser Group''). Applicants propose other conditions to limit
the potential for undue influence over the Index Funds, including that
no Investing Fund or Investing Fund Affiliate (except to the extent it
is acting in its capacity as an investment adviser to an Index Fund)
will cause an Index Fund to purchase a security in an offering of
securities during the existence of any underwriting or selling
syndicate of

which a principal underwriter is an Underwriting Affiliate
(``Affiliated Underwriting''). An ``Underwriting Affiliate'' is a
principal underwriter in any underwriting or selling syndicate that is
an officer, director, member of an advisory board, Investing Fund
Advisor, Investing Fund Subadviser, Sponsor, or employee of the
Investing Fund, or a person of which any such officer, director, member
of an advisory board, Investing Fund Adviser, Investing Fund
Subadviser, Sponsor or employee is an affiliated person. An
Underwriting Affiliate does not include a person whose relationship to
an Index Fund is covered by section 10(f) of the Act.
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    \4\ An ``Investing Fund Affiliate'' is an Investing Fund
Adviser, Investing Fund Subadviser, Sponsor, promoter, or principal
underwriter of an Investing Fund, and any person controlling,
controlled by, or under common control with any of those entities.
An ``Index Fund Affiliate'' is an investment adviser, investment
subadviser, promoter, or principal underwriter of an Index Fund, and
any person controlling, controlled by, or under common control with
any of those entities.
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    5. Applicants do not believe that the proposed arrangement will
involve excessive layering of fees. The board of directors or trustees
of any Investing Management Company, including a majority of the
directors or trustees who are not ``interested persons'' (within the
meaning of section 2(a)(19) of the Act) (``Disinterested Trustees''),
will find that the advisory fees charged under the advisory contract
are based on services provided that will be in addition to, rather than
duplicative of, the services provided under the advisory contract(s) of
any Index Fund in which the Investing Management Company may invest. In
addition, an Investing Fund Adviser, or trustee or Sponsor of an
Investing Trust will waive fees otherwise payable to it by the
Investing Management Company or Investing Trust in an amount at least
equal to any compensation (including fees received pursuant to any plan
adopted by an Index Fund under rule 12b-1 under the Act) received by
the Investing Fund Adviser or trustee or Sponsor to the Investing Trust
or an affiliated person of the Investing Fund Adviser, trustee or
Sponsor from the Index Funds in connection with the investment by the
Investment Management Company or Investing Trust in the Index Fund.
Applicants state that any sales loads or service fees charged with
respect to shares of the Investing Fund will not exceed the limits
applicable to a fund of funds as set forth in Rule 2830 of the Conduct
Rules of the NASD (``NASD Conduct Rules'').
    6. Applicants submit that the proposed arrangement will not create
an overly complex fund structure. Applicants note that no Index Fund
will acquire securities of any other investment company or company
relying on section 3(c)(1) or 3(c)(7) of the Act in excess of the
limits contained in section 12(d)(1)(A) of the Act, except to the
extent permitted by rule 12d1-1 under the Act or an exemptive order
that allows the Index Fund to purchase shares of an affiliated money
market fund for short-term cash management purposes. Before an
Investing Fund invests in an Index Fund beyond the limits of section
12(d)(1)(A)(i) of the Act, a participation agreement will be entered
into between the Index Fund and the Investing Fund (``Participation
Agreement''). The Participation Agreement will require the Investing
Fund to adhere to the terms and conditions of the requested order. The
Participation Agreement will include an acknowledgment from the
Investing Fund that it may rely on the requested order only to invest
in the Index Funds and not in any other registered investment company.
Applicants represent that each Investing Fund will represent in the
Participation Agreement that if it exceeds the 5% or 10% limitation in
section 12(d)(1)(A)(ii) and (iii) of the Act, it will disclose in its
prospectus that it may invest in the Index Funds, and disclose in
``plain English'' in its prospectus the unique characteristics of doing
so, including but not limited to, the expense structure and any
additional expenses of investing in the Index Funds. Each Investing
Fund will also be required to represent in the Participation Agreement
that it will comply with the disclosure requirements set forth in
Investment Company Act Release No. 27399 (June 20, 2006).
    7. Applicants also note that an Index Fund may choose to reject a
direct purchase by an Investing Fund. To the extent that an Investing
Fund purchases shares of an Index Fund in the secondary market, the
Index Fund would still retain its ability to reject purchases of its
shares through its decision to enter into the Participation Agreement
prior to any investment by an Investing Fund in excess of the limits of
section 12(d)(1)(A)(i).

B. Section 17(a)

    1. Section 17(a) of the Act generally prohibits sales or purchases
of securities between a registered investment company and any
affiliated person of the company. Section 2(a)(3) of the Act defines an
``affiliated person'' of another person to include any person 5% or
more of whose outstanding voting securities are directly or indirectly
owned, controlled, or held with power to vote by the other person.
    2. Applicants seek relief from section 17(a) to permit an Index
Fund that is an affiliated person of an Investing Fund because the
Investing Fund holds 5% or more of the Index Fund's shares to sell its
shares to and redeem its shares from an Investing Fund.\5\ Applicants
believe that any proposed transactions directly between an Index Fund
and an Investing Fund will be consistent with the policies of each
Index Fund and Investing Fund. The Participation Agreement will require
any Investing Fund that purchases shares from an Index Fund to
represent that the purchase of shares from the Index Fund by the
Investing Fund will be accomplished in compliance with the investment
restrictions of the Investing Fund and will be consistent with the
investment policies set forth in the Investing Funds' registration
statement.\6\
---------------------------------------------------------------------------

    \5\ Applicants acknowledge that receipt of any compensation by
(a) an affiliated person of an Investing Fund, or an affiliated
person of such person, for the purchase by the Investing Fund of
shares of an Index Fund or (b) an affiliated person of an Index
Fund, or an affiliated person of such person, for the sale by the
Index Fund of its shares to an Investing Fund is subject to section
17(e) of the Act. The Participation Agreement also will include this
acknowledgment.
    \6\ To the extent that purchases and sales of shares of an Index
Fund occur in the secondary market and not through principal
transactions directly between an Investing Fund and an Index Fund,
relief from section 17(a) would not be necessary. However, the
requested relief would apply to direct sales of shares in Creation
Units by an Index Fund to an Investing Fund and redemptions of those
shares. The requested relief is also intended to cover the in-kind
transactions that would accompany such sales and redemptions, as
described in the application for the ETF Order.
---------------------------------------------------------------------------

    3. Section 17(b) of the Act authorizes the Commission to grant an
order permitting a transaction otherwise prohibited by section 17(a) if
it finds that: (i) The terms of the proposed transaction are fair and
reasonable and do not involve overreaching on the part of any person
concerned; (ii) the proposed transaction is consistent with the
policies of each registered investment company involved; and (iii) the
proposed transaction is consistent with the general purposes of the
Act. Section 6(c) of the Act permits the Commission to exempt any
person or transaction from any provision of the Act if such exemption
is necessary or appropriate in the public interest and consistent with
the protection of investors and the purposes fairly intended by the
policy and provisions of the Act.
    4. Applicants submit that the proposed transactions satisfy the
standards for relief under sections 17(b) and 6(c) of the Act.
Applicants state that the terms of the transactions are fair and
reasonable and do not involve overreaching. Applicants note that any
consideration paid by an Investing Fund for the purchase or redemption
of shares directly from an Index Fund will be based on the net asset
value of the Index Fund. Applicants state that the

proposed transactions will be consistent with the policies of each
Index Fund and Investing Fund and with the general purposes of the Act.

Applicants' Conditions

    Applicants agree that any order granting the requested relief will
be subject to the following conditions:
    1. The members of the Investing Fund Adviser/Sponsor Group will not
control (individually or in the aggregate) an Index Fund within the
meaning of section 2(a)(9) of the Act. The members of the Subadviser
Group will not control (individually or in the aggregate) an Index Fund
within the meaning of section 2(a)(9) of the Act. If, as a result of a
decrease in the outstanding voting securities of an Index Fund, the
Investing Fund Adviser/Sponsor Group or the Subadviser Group, each in
the aggregate, becomes a holder of more than 25% of the outstanding
voting securities of the Index Fund, it will vote its shares of the
Index Fund in the same proportion as the vote of all other holders of
the Index Fund's shares. This condition does not apply to the
Subadviser Group with respect to an Index Fund for which the Investing
Fund Subadviser or a person controlling, controlled by, or under common
control with the Investing Fund Subadviser acts as the investment
adviser within the meaning of section 2(a)(20)(A) of the Act.
    2. No Investing Fund or Investing Fund Affiliate will cause any
existing or potential investment by the Investing Fund in an Index Fund
to influence the terms of any services or transactions between the
Investing Fund or an Investing Fund Affiliate and the Index Fund or
Index Fund Affiliate.
    3. The board of directors or trustees of an Investing Management
Company, including a majority of the Disinterested Trustees, will adopt
procedures reasonably designed to assure that the Investing Fund
Adviser and any Investing Fund Subadviser are conducting the investment
program of the Investing Management Company without taking into account
any consideration received by the Investing Management Company or an
Investing Fund Affiliate from an Index Fund or an Index Fund Affiliate
in connection with any services or transactions.
    4. Once an investment by an Investing Fund in the securities of an
Index Fund exceeds the limit in section 12(d)(1)(A)(i) of the Act, the
board of trustees of the Index Fund, including a majority of the
Disinterested Trustees, will determine that any consideration paid by
the Index Fund to the Investing Fund or an Investing Fund Affiliate in
connection with any services or transactions: (a) Is fair and
reasonable in relation to the nature and quality of the services and
benefits received by the Index Fund; (b) is within the range of
consideration that the Index Fund would be required to pay to another
unaffiliated entity in connection with the same services or
transactions; and (c) does not involve overreaching on the part of any
person concerned. This condition does not apply with respect to any
services or transactions between an Index Fund and its investment
adviser(s), or any person controlling, controlled by, or under common
control with such investment adviser(s).
    5. No Investing Fund or Investing Fund Affiliate (except to the
extent it is acting in its capacity as an investment adviser to an
Index Fund) will cause an Index Fund to purchase a security in any
Affiliated Underwriting.
    6. The board of trustees of the Index Fund, including a majority of
the Disinterested Trustees, will adopt procedures reasonably designed
to monitor any purchases of securities by an Index Fund in an
Affiliated Underwriting once an investment by an Investing Fund in
Shares of the Index Fund exceeds the limit in section 12(d)(1)(A)(i) of
the Act, including any purchases made directly from an Underwriting
Affiliate. The board will review these purchases periodically, but no
less frequently than annually, to determine whether the purchases were
influenced by the investment by the Investing Fund in the Index Fund.
The board will consider, among other things: (i) Whether the purchases
were consistent with the investment objectives and policies of the
Index Fund; (ii) how the performance of securities purchased in an
Affiliated Underwriting compares to the performance of comparable
securities purchased during a comparable period of time in
underwritings other than Affiliated Underwritings or to a benchmark
such as a comparable market index; and (iii) whether the amount of
securities purchased by the Index Fund in Affiliated Underwritings and
the amount purchased directly from an Underwriting Affiliate have
changed significantly from prior years. The board shall take any
appropriate actions based on its review, including, if appropriate, the
institution of procedures designed to assure that purchases of
securities in Affiliated Underwritings are in the best interest of
shareholders.
    7. Each Index Fund shall maintain and preserve permanently in an
easily accessible place a written copy of the procedures described in
the preceding condition, and any modifications, and shall maintain and
preserve for a period of not less than six years from the end of the
fiscal year in which any purchase in an Affiliated Underwriting
occurred, the first two years in an easily accessible place, a written
record of each purchase of securities in Affiliated Underwritings once
an investment by an Investing Fund in the Shares of the Index Fund
exceeds the limit in section 12(d)(1)(A)(i) setting forth from whom the
securities were acquired, the identity of the underwriting syndicate's
members, the terms of the purchase, and the information or materials
upon which the board's determinations were made.
    8. Prior to investing in an Index Fund in excess of the limits in
section 12(d)(1)(A)(i), each Investing Fund and the Index Fund will
execute a Participation Agreement stating, without limitation, that
their boards of directors/trustees and their investment advisers, or
their Sponsors and trustees, as applicable, understand the terms and
conditions of the order and agree to fulfill their responsibilities
under the order. At the time of its investment in shares of an Index
Fund in excess of the limit in section 12(d)(1)(A)(i), an Investing
Fund will notify the Index Fund of the investment. At such time, the
Investing Fund will also transmit to the Index Fund a list of the names
of each Investing Fund Affiliate and Underwriting Affiliate. The
Investing Fund will notify the Index Fund of any changes to the list of
the names as soon as reasonably practicable after a change occurs. The
Index Fund and the Investing Fund will maintain and preserve a copy of
the order, the Participation Agreement, and the list with any updated
information for the duration of the investment and for a period of not
less than six years thereafter, the first two years in an easily
accessible place.
    9. Prior to approving any advisory contract under section 15 of the
Act, the board of directors/trustees of each Investing Management
Company, including a majority of the Disinterested Trustees, will find
that the advisory fees charged under such advisory contract are based
on services provided that will be in addition to, rather than
duplicative of, the services provided under the advisory contract(s) of
any Index Fund in which the Investing Management Company may invest.
These findings and their basis will be recorded fully in the minute
books of the appropriate Investing Management Company.
    10. An Investing Fund Adviser, or trustee or Sponsor of an
Investing Trust will waive fees otherwise payable to it

by the Investing Management Company or Investing Trust in an amount at
least equal to any compensation (including fees received pursuant to
any plan adopted by an Index Fund under rule 12-1 under the Act)
received from an Index Fund by the Investing Fund Adviser, trustee, or
Sponsor to the Investing Trust or an affiliated person of the Investing
Fund Adviser, trustee or Sponsor, other than any advisory fees paid to
the Investing Fund Adviser, trustee or Sponsor or an affiliated person
of the Investing Fund Adviser, trustee or Sponsor by the Index Fund, in
connection with the investment by the Investing Management Company or
Investing Trust in the Index Fund. Any Investing Fund Subadviser will
waive fees otherwise payable to the Investing Fund Subadviser, directly
or indirectly, by the Investing Management Company in an amount at
least equal to any compensation received from an Index Fund by the
Investing Fund Subadviser, or an affiliated person of the Investing
Fund Subadviser, other than any advisory fees paid to the Investing
Fund Subadviser or its affiliated person by the Index Fund in
connection with the investment by the Investing Management Company in
the Index Fund made at the direction of the Investing Fund Subadviser.
In the event that the Investing Fund Subadviser waives fees, the
benefit of the waiver will be passed through to the Investing
Management Company.
    11. Any sales charges and/or service fees charged with respect to
shares of an Investing Fund will not exceed the limits applicable to a
fund of funds as set forth in Rule 2830 of the NASD Conduct Rules.
    12. No Index Fund will acquire securities of any investment company
or company relying on section 3(c)(1) or 3(c)(7) of the Act in excess
of the limits contained in section 12(d)(1)(A) of the Act, except to
the extent permitted by rule 12d1-1 under the Act or an exemptive order
that allows the Index Fund to purchase shares of an affiliated money
market fund for short-term cash management purposes.

    For the Commission, by the Division of Investment Management,
pursuant to delegated authority.
Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-8595 Filed 5-4-07; 8:45 am]

BILLING CODE 8010-01-P


Comment Info: =================

General Comment:Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved the lives of my sons.  They were heavy smokers and had tried everything available to quit smoking cigarettes.  My youngest son would get up every morning and cough for 1/2 hour before he could do anything else.  He has been using e-cigarettes for about 3 years.  He no longer coughs in the morning.  He has a lot more energy.  He told me the other day, he can now taste food for the first time in many years.  As a mother, I am very concerned about the health of my adult children.  I know the science is still out on e-cigs but I do feel better about them using the e-cig compared to smoking the combustible cigarettes.

Thank you for reading my personal story. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I appreciate your consideration of my request and am happy to discuss this issue with you further.

Concerned mother,

Laurel


[Federal Register Volume 84, Number 33 (Tuesday, February 19, 2019)]
[Notices]
[Pages 4883-4885]
[FR Doc No: 2019-02608]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-85111; File No. SR-NASDAQ-2019-005]

Self-Regulatory Organizations; The Nasdaq Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Amend Certain Rules of the Rule 7000A Series Concerning the Order Audit
Trail System

February 12, 2019.
    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 February 1, 2019, The Nasdaq Stock Market LLC (``Nasdaq'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by the Exchange. The
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 Substance
of the Proposed Rule Change

    The Exchange proposes to amend certain rules of the Rule 7000A
Series concerning the Order Audit Trail System to make conforming and
technical changes. The text of the proposed rule change is available on
the Exchange's website at http://nasdaq.cchwallstreet.com, at the
principal office of the Exchange, and at the Commission's Public
Reference Room.

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

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant 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 is proposing to amend certain rules of the Rule 7000A
Series concerning FINRA's Order Audit Trail System (``OATS'') to make
conforming and technical changes. The Exchange's Rule 7000A Series
imposes an obligation on Exchange members to record in electronic form
and report to FINRA on a daily basis certain information with respect
to orders originated, received, transmitted, modified, canceled, or
executed by members in Nasdaq-listed stocks. OATS captures this order
information and integrates it with quote and transaction information to
create a time-sequenced record of orders, quotes, and transactions.
This information is used by FINRA staff to conduct surveillance and
investigations of members for potential violation of Exchange rules,
federal securities laws, and FINRA rules. As such, the Exchange and its
sister exchanges, Nasdaq BX, Inc. (``BX'') and Nasdaq PHLX LLC
(``PHLX''), endeavor to keep their OATS rules consistent with FINRA's
OATS rules, as well as with each other's.
    BX and PHLX recently updated and harmonized their respective OATS
rules with those of the Exchange and FINRA. Through this process,
several technical issues were identified with the Exchange's OATS rules
that require a rule change. This proposed rule change makes those
changes.\3\
---------------------------------------------------------------------------

    \3\ The Exchange is making a technical change to the rule
numbering under the Rule 7000A Series to add a period after the
individual rule numbers under the Series.
---------------------------------------------------------------------------

    First, the Exchange is proposing to amend Rule 7410A, which defines
terms used in the OATS rules. The Exchange is proposing to change the
reference to the Rule 7400A Series immediately under the title of the
Rule to instead reference the Rule 7000A Series, which is the correct
citation. The Exchange is also proposing to amend the definition of
``Nasdaq Market Center'' under Rule 7410A(d). Nasdaq has a more
comprehensive definition of the ``Nasdaq Market Center'' under Rule
4701(a). As a consequence, the Exchange is proposing to amend Rule
7410A(d) to note that the term ``Nasdaq Market Center'' has the same
meaning as that term has under Rule 4701(a). The Exchange is adding an
omitted hyphen to the term ``over-the-counter'' within the definition
of ``Electronic Communication Network.'' The Exchange is also proposing
to delete the defined term ``NMS stock'' from paragraph (j) of the
rule, and re-letter the remaining rules accordingly. The term ``NMS
stock'' is not used in Nasdaq's OATS rules. The term is used in FINRA
Rule 7410(k), defining ``Order Audit Trail System, whereas the Exchange
instead references Nasdaq listed securities under Rule 7410A(l).
Moreover, neither BX nor PHLX defines the term in its respective OATS
rules. Thus, the Exchange believes that the defined term is not needed
for purposes of its OATS rules, and is accordingly deleting the
definition and re-lettering the subparagraphs that follow. The Exchange
is proposing to apply lower case letters to the term bona fide hedge
transaction within the definition of ``Order'' under re-lettered
paragraph (j). The Exchange notes that it currently capitalizes the
term ``Bona Fide Hedge Transaction'' under the rule, although the term
is not defined in Nasdaq's rules. The Exchange believes that
capitalizing the term was an error and is therefore not capitalizing
the term in Rule 7410A(j). The Exchange notes that neither BX nor PHLX
chose to capitalize the term for purposes of their [sic] OATS rules.
The Exchange is proposing to move text within the definition of
``Reporting Member'' to conform it to how BX and PHLX present the
subparagraphs within their definition of ``Reporting Member'' and
``Reporting Member Organization,'' respectively. Last, the Exchange is
proposing to amend Rule 7410A(o) to cross-reference the definition of
[sic] term ``customer'' under Rule 7410A(c) instead of cross-
referencing the definition under Rule 0120(g), which is equivalent to
the definition under Rule 7410A(c).
    Second, the Exchange is proposing to amend Rule 7440A to delete a
sentence from Rule 7440A(a), which notes that members are complying
with these rules by complying with the related FINRA rules 7440(a). The
Exchange believes these sentences are duplicative of the

first sentence of Rule 7440A(a), which states that Nasdaq members and
persons associated with a member shall comply with FINRA Rule 7440 as
if such Rule were part of Nasdaq's rules. The Exchange notes that
neither BX nor PHLX chose to incorporate that sentence into their [sic]
related OATS rules.
    Third, the Exchange is proposing to amend Rule 7450A(b) to include
the term ``associated persons.'' Rule 7450A concerns order data
transmission requirements, and paragraph (b) thereunder provides the
requirements applicable to proprietary trading firms. Both BX and PHLX
apply their related rules to both proprietary trading firms and their
associated persons. The Exchange believes that it was an omission to
not include associated persons under the rule and is therefore
including associated persons thereunder.
    Last, the Exchange is proposing to clarify under Rules 7440A and
7450A that certain rules cited thereunder are FINRA rules. The Exchange
is also clarifying under Rules 7440A(a) and 7450A(a) that the
regulatory services contract noted under the rule is an agreement with
FINRA. These clarifying changes will also harmonize the pertinent parts
of Rules 7440A and 7450A with the respective rules of BX and PHLX.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\4\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\5\ in particular, in that it is designed to promote
just and equitable principles of trade, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general to protect investors and the public interest,
by harmonizing the Exchange's OATS rules with those of BX and PHLX,
with which they should materially match. Consequently, the proposed
change will promote consistent regulatory standards with respect to
rules that FINRA enforces pursuant to its Regulatory Services
Agreements with the Exchange, BX and PHLX. With respect to the proposed
technical corrections to the rules, the Exchange believes that these
changes are consistent with the Act because they will prevent investor
confusion that may be caused by inconsistencies and vagueness in the
Rules.
---------------------------------------------------------------------------

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

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 rule change align
[sic] the Exchange's rules with those of BX and PHLX, which will assist
FINRA in its oversight work done pursuant to a regulatory services
agreement with the Exchange. The proposed changes also provide uniform
standards with which market participants must comply. Consequently, the
Exchange does not believe that the proposed changes implicate
competition at all.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \6\ and Rule 19b-
4(f)(6) thereunder.\7\
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78s(b)(3)(A).
    \7\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the
Act \8\ normally does not become operative for 30 days after the date
of its filing. However, Rule 19b-4(f)(6)(iii) \9\ permits the
Commission to designate a shorter time if such action is consistent
with the protection of investors and the public interest. The Exchange
has requested that the Commission waive the 30-day operative delay so
that the proposed rule change may become operative upon filing. Waiver
of the operative delay would allow the Exchange to update its rules
without delay to make technical changes that would improve clarity and
simplify FINRA's work under the Regulatory Services Agreements with the
Exchange, BX, and PHLX. Therefore, the Commission believes that waiver
of the 30-day operative delay is consistent with the protection of
investors and the public interest. Accordingly, the Commission hereby
waives the operative delay and designates the proposed rule change
operative upon filing.\10\
---------------------------------------------------------------------------

    \8\ 17 CFR 240.19b-4(f)(6).
    \9\ 17 CFR 240.19b-4(f)(6)(iii).
    \10\ For purposes only of waiving the 30-day operative delay,
the Commission also has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule change 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-NASDAQ-2019-005 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2019-005. 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 website (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 website 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
the filing also will be available for inspection and copying at the
principal office of the Exchange. All comments received will be posted
without change. Persons submitting comments are cautioned that we do
not redact or edit personal identifying information from comment
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-
NASDAQ-2019-005 and should be submitted on or before March 12, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
---------------------------------------------------------------------------

    \11\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-02608 Filed 2-15-19; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 75, Number 224 (Monday, November 22, 2010)]
[Notices]
[Pages 71126-71127]
[FR Doc No: 2010-29399]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9229-8]

Proposed Consent Decree, Clean Air Act Citizen Suit

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of Proposed Consent Decree; Request for Public Comment.

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SUMMARY: In accordance with section 113(g) of the Clean Air Act, as
amended (``CAA'' or the ``Act''), 42 U.S.C. 7413(g), notice is hereby
given of a proposed consent decree to address a lawsuit filed by Sierra
Club and Medical Advocates for Healthy Air (collectively
``Plaintiffs'') in the United States District Court for the Northern
District of California: Sierra Club, et al. v. Jackson, No. 10-cv-01954
VRW (N.D. CAO.). On May 6, 2010, Plaintiffs filed a complaint alleging
that EPA failed to perform a mandatory duty under section 110(k)(2) of
the CAA, 42 U.S.C. 7410(k)(2) to take timely final action to approve,
disapprove, or partially approve/disapprove the San Joaquin Valley Air
Pollution Control District's 8-Hour Ozone Plan, which was submitted to
EPA on November 16, 2007. The proposed consent decree establishes a
deadline for EPA to take action.

DATES: Written comments on the proposed consent decree must be received
by December 22, 2010.

ADDRESSES: Submit your comments, identified by Docket ID number EPA-HQ-
OGC-2010-0942, online at http://www.regulations.gov (EPA's preferred
method); by e-mail to<EMAIL_ADDRESS>by mail to EPA Docket Center,
Environmental Protection Agency, Mailcode: 2822T, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001; or by hand delivery or courier to
EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave., NW.,
Washington, DC, between 8:30 a.m. and 4:30 p.m. Monday through Friday,
excluding legal holidays. Comments on a disk or CD-ROM should be
formatted in Word or ASCII file, avoiding the use of special characters
and any form of encryption, and may be mailed to the mailing address
above.

FOR FURTHER INFORMATION CONTACT: Jan Tierney, Air and Radiation Law
Office (2344A), Office of General Counsel, U.S. Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone:<PHONE_NUMBER>; fax number<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Additional Information About the Proposed Consent Decree

    The proposed consent decree would resolve a lawsuit seeking to
compel the Administrator to take timely final action under section
110(k) of the CAA to approve, disapprove, or partially approve/
disapprove the San Joaquin Valley Air Pollution Control District's 8-
Hour Ozone Plan, which was submitted to EPA on November 16, 2007 (8-
Hour Ozone Plan). The proposed consent decree requires that no later
than December 15, 2011, EPA shall sign a notice of the Agency's final
action on the 8-Hour Ozone Plan pursuant to section 110(k) of the CAA,
and thereafter send the notice to the Office of the Federal Register
for publication. After EPA fulfills its obligations under the decree,
the parties shall file a joint request to the Court to dismiss this
matter with prejudice.
    For a period of thirty (30) days following the date of publication
of this notice, the Agency will accept written comments relating to the
proposed consent decree from persons who were not named as parties or
intervenors to the litigation in question. EPA or the Department of
Justice may withdraw or withhold consent to the proposed consent decree
if the comments disclose facts or considerations that indicate that
such consent is inappropriate, improper, inadequate, or inconsistent
with the requirements of the Act. Unless EPA or the Department of
Justice determines that consent to this consent decree should be
withdrawn, the terms of the decree will be affirmed.

II. Additional Information About Commenting on the Proposed Consent
Decree

A. How can I get a copy of the consent decree?

    The official public docket for this action (identified by Docket ID
No. EPA-HQ-OGC-2010-0942) contains a copy of the proposed consent
decree. The official public docket is available for public viewing at
the Office of Environmental Information (OEI) Docket in the EPA Docket
Center, EPA West, Room 3334, 1301 Constitution Ave., NW., Washington,
DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to
4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Public Reading Room is<PHONE_NUMBER>, and the
telephone number for the OEI Docket is<PHONE_NUMBER>.
    An electronic version of the public docket is available through
http://www.regulations.gov. You may use http://www.regulations.gov to
submit or view public comments, access the index listing of the
contents of the official public docket, and to access those documents
in the public docket that are available electronically. Once in the
system, key in the appropriate docket identification number then select
``search''.
    It is important to note that EPA's policy is that public comments,
whether submitted electronically or in paper, will be made available
for public viewing online at http://www.regulations.gov without change,
unless the comment contains copyrighted material, CBI, or other
information whose disclosure is restricted by statute. Information
claimed as CBI and other information whose disclosure is restricted by
statute is not included in the official public docket or in the
electronic public docket. EPA's policy is that copyrighted material,
including copyrighted material contained in a public comment, will not
be placed in EPA's electronic public docket but will be available only
in printed, paper form in the official public docket. Although not all
docket materials may be available electronically, you may still access
any of the publicly available docket materials through the EPA Docket
Center.

B. How and to whom do I submit comments?

    You may submit comments as provided in the ADDRESSES section.
Please ensure that your comments are submitted within the specified
comment period. Comments received after the close of the comment period
will be marked ``late.'' EPA is not required to consider these late
comments.
    If you submit an electronic comment, EPA recommends that you
include your name, mailing address, and an e-mail address or other
contact information in the body of your comment and with any disk or
CD-ROM you submit. This ensures that you can be identified as the
submitter of the comment and allows EPA to contact you in case EPA
cannot read your comment due to technical difficulties or needs further
information on the substance of your comment. Any identifying or
contact information provided in the body of a comment will be included
as part of the comment that is placed in the official public docket,
and made available in EPA's electronic public docket. If EPA cannot
read your comment due to technical difficulties and cannot contact you
for clarification, EPA may not be able to consider your comment.
    Use of the http://www.regulations.gov website to submit comments to
EPA electronically is EPA's preferred method for receiving comments.
The electronic public docket system is an ``anonymous access'' system,
which means EPA will not know your identity, e-mail address, or other
contact information unless you provide it in the body of your comment.
In contrast to EPA's electronic public docket, EPA's electronic mail
(e-mail) system is not an ``anonymous access'' system. If you send an
e-mail comment directly to the Docket without going through http://www.regulations.gov, your e-mail address is automatically captured and
included as part of the comment that is placed in the official public
docket, and made available in EPA's electronic public docket.

    Dated: November 12, 2010.
Richard B. Ossias,
Associate General Counsel.
[FR Doc. 2010-29399 Filed 11-19-10; 8:45 am]
BILLING CODE 6560-50-P


1 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON D. C., 20460 MEMORANDUM PC Code: 109901 DP Barcode: D325054 SUBJECT: Environmental Fate and Effects Division Error only corrections and revised Triadimefon RED FROM: Michelle Rau Embry, Ph. D. Jonathan Angier, Ph. D. Environmental Risk Branch II Environmental Fate and Effects Division ( 7507C)

TO: John Pates, Jr. Chemical Review Manager Reregistration Division ( 7508C)

THROUGH: Dana Spatz, RAPL Tom Bailey, Ph. D., Branch Chief Environmental Risk Branch II Environmental Fate and Effects Division ( 7507C)

DATE: January 19, 2006 The following are the Environmental Fate and Effects Division ( EFED) responses to Bayer's Error Correction Comments dated December 28, 2005.

13. Triadimefon Ecological Risk Assessment, Page 12, Paragraph 3, Lines 22 23 EPA Statement: " Although another triadimefon degradate is formed, triazole, no toxicity data are available and therefore it is not considered in this assessment"

Bayer's response: " Data is available for the triazole metabolite and has been submitted to the Agency under the US Triazole Task Force. The triazole risk assessment is being performed under a separate analysis. BCS recommends the Agency to revise the statement to accurately reflect the status of the triazole data and assessment." 2 EPA response: The statement has been changed to read, " 1,2,4 triazole is also formed as a degradate of triadimefon; however, this compound is not addressed in this risk assessment and will be examined in a future separate risk assessment by the Agency."

14. Triadimefon Ecological Risk Assessment, Page 12, Paragraph 4, Lines 2 4 EPA statement: " Additionally, aquatic environment exposure is a major focus, due to the large runoff potential resulting from triadimefon use on golf courses, residential lawns, and other turf area "

Bayer's response: " The assessment appears to be quite comprehensive, with equal weighting given to both terrestrial and aquatic risks."

EPA response: Although this assessment does give equal focus to both terrestrial and aquatic risks, the aforementioned paragraph is simply discussing the triadimefon use ( turf) that contributed most heavily to the overall triadimefon risk picture.

15. Triadimefon Ecological Risk Assessment, Page 19, Paragraph 4, Lines 3 6 EPA statement: " EPA re iterates that there is no data available for the triazole metabolite."

Bayer response: " As mentioned above, this statement should be corrected to accurately reflect the status of the triazole data and assessment."

EPA response: The wording of the aforementioned paragraph was changed to, " 1,2,4 triazole is also formed as a degradate of triadimefon; however, this compound is not addressed in this risk assessment and will be examined in a future separate risk assessment by the Agency."

16. Triadimefon Ecological Risk Assessment, Page 19, Paragraph 4, Lines 3 6 EPA statement: " The fathead minnow study demonstrated a NOAEL of 1700 ppb based on adult survival ( MRID 41922103)

Bayer's response: " The NOAEL from the cited study should be 170 ppb ( 0.170 ppm)

EPA response: The correction was made to the text. All tables and RQ calculations in the original document were made using the correct ( 170 ppb) value.

17. Triadimefon Ecological Risk Assessment, Page 49, Paragraph 5, Lines 1 2 3 EPA statement: " The acute oral toxicity of triadimefon ( TGAI) to 14 day old mallard ducks ( Anas platyrhynchos) was assessed over 8 days ( MRID 50070)."

Bayer response: " There is no avian study listed in Appendix C with this MRID number. The number provided in Appendix C ( page 170) may be the CDL number ( see citation below). Either the text on page 49 or Appendix C needs to be corrected. The correct MRID according to NPIRS is 00050070.

EPA response: Both Appendix C and the text MRID numbers were corrected to 00050070 ( Lamb, 1977).

18. Triadimefon Ecological Risk Assessment, Page 49, Paragraph 5, Lines 2 3 EPA statement: " The 8 day acute oral LD50 exceeded the highest does tested (> 5000 mg ai/ kg bw)."

Bayer response: " As noted in Appendix C ( page 172), the acute oral LD50 for mallard ducks is > 4000 mg ai/ kg bw.

EPA response: The text was corrected to reflect an acute oral LD50 value of > 4000 mg ai/ kg bw for mallard ducks.

19. Triadimefon Ecological Risk Assessment, Page 50, Paragraph 1, Line 3 EPA statement: EPA provides the MRID number for the northern bobwhite quail study as 50067.

Bayer response: " The MRID number for the northern bobwhite quail study is 00050066."

EPA response: The MRID number was corrected to 00050066.

20. Triadimefon Ecological Risk Assessment, Page 50, Paragraph 2, Line 2 EPA statement: " The acute oral ( LC50) toxicity of triadimenol "

Bayer response: " The parenthetical statement should read ( LD50)."

EPA response: The parenthetical statement was corrected to read ( LD50).

21. Triadimefon Ecological Risk Assessment, Page 60, Table 23 Heading 4 EPA statement: EPA provided the endpoint used in the acute risk characterization, but not the chronic.

Bayer response: " BCS recommends that the chronic endpoint of interest be added to the heading table."

EPA response: The chronic endpoint ( NOAEC of 50mg/ kg diet) was added to the table heading.

22. Triadimefon Ecological Risk Assessment, Page 170, Table Toxicity of the degradate, triadimenol, to birds  acute EPA statement: Second study listed   Mallard duck LD50> 5000 MRID 071469 Lamb Bayer response: " BCS believes the study being cited is an avian dietary subacute ( LC50) for the triadimenol metabolite. In the study, the LC50 values for both bobwhite quail and mallard duck were > 5000 ppm ( see citation below). The table should be corrected, a new table for LC50 values prepared. Additionally, earlier in the document ( e. g., page 46 ( Table 18), page 50 ( 2nd paragraph), and perhaps elsewhere) the chapter notes that dietary data is not available for the metabolite. These statements should be corrected.

00126277 Lamb D.; Toll, P.; Mallicoat, D.; et al. ( 1981) Acute Dietary LC50 of Techinical Triadimenol ( Baytan) to Mallard Ducks and Bobwhite Quail: Study No. 80 175 09 and 80 175 05. ( Unpublished study received Mar 11, 1983 under 3125 346; submitted by Mobay Chemical Corp., Kansas City, MO; CDL: 071469 F)

EPA response: The subacute dietary study ( MRID 00126277) was added to the toxicity tables in Appendix C, as well as page 46, Table 2. It is noted throughout the chapter that dietary data is available for the triadimefon metabolite, triadimenol.

23. Triadimefon Ecological Risk Assessment, Page 171, Table Toxicity of triadimefon to birds   subacute dietary EPA statement: Fourth study listed   Mallard duck LC50> 4650 MRID 00050067 Fink/ 1977 Bayer response: " In the study with the MRID 00050067, no birds died at the highest level tested ( 10,000 ppm). Therefore the LC50 should be > 10,000 ppm EPA response: The LC50 was corrected to > 10,000ppm.

24. Triadimefon Ecological Risk Assessment, Page 171, Table Mammalian Toxicity of Triadimenol 5 Bayer comment: " The table has no entries. Bayer recommends that the table be completed."

EPA response: The table has been completed.

25. Triadimefon Ecological Risk Assessment, Page 57, Last line EPA statement: " No RQ values were calculated for estuarine/ marine fish and invertebrates because to toxicity "

Bayer response: " The statement should read,   because no

EPA response: The sentence was corrected.