[Federal Register: October 6, 2009 (Volume 74, Number 192)]
[Notices]
[Page 51271]
[DOCID:fr06oc09-38]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EF09-3031-000]

Southwestern Power Administration; Notice of Filing

September 29, 2009.
    Take notice that on September 22, 2009, the Deputy Secretary, U.S.
Department of Energy, pursuant to the authority vested by the
Department of Energy's Delegation Order Nos. 00-001.00C and 00-037.00,
and by section 302(a) of the Department of Energy Organization Act
(Pub. L. 95-91), submitted Rate Order SEPA-51, approved on an interim
basis, effective September 20, 2009, Rate Schedules JW-1-I and JW-2-F
for the sale of power from the Jim Woodruff System, and submitted for
confirmation and approval on a final basis, pursuant to the authority
vested in the Federal Energy Regulatory Commission by Delegation Order
No. 00-037.00, Rate Schedule JW1-I, effective September 20, 2009
through September 19, 2014.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on October 22, 2009.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-23987 Filed 10-5-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 247 (Thursday, December 27, 2018)]
[Notices]
[Page 66704]
[FR Doc No: 2018-28040]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EF19-1-000]

Western Area Power Administration; Notice of Filing

    Take notice that on December 13, 2018, Western Area Power
Administration submitted tariff filing per: Extension of Firm Electric
and Transmission Service Formula Rates for Parker-Davis Project-Western
Area Power Administration-Rate Order No. WAPA-184 to be effective 12/
31/2018.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE, Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the website that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on January 14, 2019.

    Dated: December 19, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-28040 Filed 12-26-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: August 3, 2006 (Volume 71, Number 149)]
[Notices]
[Page 44022]
[DOCID:fr03au06-37]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. CP06-425-000 and CP06-426-000]

Discovery Producer Services LLC, Discovery Gas Transmission LLC;
Notice of Filing

July 27, 2006.
    Take notice that on July 20, 2006, Discovery Producer Services LLC
(DPS) and Discovery Gas Transmission LLC (Discovery) jointly filed an
abbreviated application for the certificates of public convenience and
necessity, pursuant to section 7(c) of the Natural Gas Act (NGA) and
Part 157 of the Commission's Rules and Regulations, authorizing DPS to
provide Discovery the use of capacity on DPS' non-jurisdictional
gathering facilities through a capacity lease, to effectuate the
transportation of natural gas received from Texas Eastern Transmission,
LP (Texas Eastern) for delivery to DPS' Larose processing plant and for
ultimate delivery downstream into the interstate pipeline grid. The
application is on file with the Commission and open for public
inspection. This filing is available for review at the Commission in
the Public Reference Room or may be viewed on the Commission's Web site
at http://www.ferc.gov using the ``eLibrary'' link. Enter the docket

number excluding the last three digits in the docket number field to
access the document. For assistance, please contact FERC Online Support
at<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for
TTY, contact<PHONE_NUMBER>.
    On October 11, 2005, the Commission granted the emergency
authorization allowing DPS to deliver gas supplies received from Texas
Eastern, into its 20-inch non-jurisdictional gathering line to
Discovery's jurisdictional facilities for subsequent delivery to the
Larose processing plant. Because of the threat of potential supply
disruptions due to the storms in the Gulf Coast region remains an
ongoing concern, DPS and Discovery request Commission authorization to
make permanent the limited term emergency transportation service which
will expire on November 30, 2006. DPS will make available capacity, up
to 300,000 Dts per day, on DPS' 20-inch non-jurisdictional gathering
line to Discovery. This proposed capacity will be provided to Discovery
on an interruptible basis through a capacity lease arrangement (Lease
Agreement). The service offered to Discovery through the Lease
Agreement will be strictly ancillary to DPS' primary business of
providing gathering, processing, treating, and compression services in
Louisiana. DPS requests a limited jurisdiction certificate to permit
Discovery's use of DPS' non-jurisdictional facilities without having
DPS' gathering and processing facilities, and operations becoming
subject to the Commission's jurisdiction and the full panoply of the
NGA. The pipeline interconnects and facilities necessary to provide
this transportation service already exist. No new facilities will be
required.
    Any questions regarding the application are to be directed to Kevin
R. Rehm, Vice President, Discovery Producer Services LLC, Discovery Gas
Transmission LLC, 2800 Post Oak Boulevard, Houston, Texas 77056; phone
number<PHONE_NUMBER>.
    Any person wishing to obtain legal status by becoming a party to
the proceedings for this project should, on or before the below listed
comment date, file with the Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426, a motion to intervene in
accordance with the requirements of the Commission's Rules of Practice
and Procedure (18 CFR 385.214 or 385.211) and the Regulations under the
NGA (18 CFR 157.10). A person obtaining party status will be placed on
the service list maintained by the Secretary of the Commission and will
receive copies of all documents filed by the applicant and by all other
parties. A party must submit 14 copies of filings made with the
Commission and must mail a copy to the applicant and to every other
party in the proceeding. Only parties to the proceeding can ask for
court review of Commission orders in the proceeding.
    Motions to intervene, protests and comments may be filed
electronically via the Internet in lieu of paper, see, 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. The Commission strongly encourages
electronic filings.
    Comment Date: August 17, 2006.

Magalie R. Salas,
Secretary.
[FR Doc. E6-12506 Filed 8-2-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 161 (Friday, August 19, 2011)]
[Notices]
[Pages 52034-52037]
[FR Doc No: 2011-21173]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-65134; File No. SR-NYSEArca-2011-23]

Self-Regulatory Organizations; NYSE Arca, Inc.; Order Granting
Approval of Proposed Rule Change To List and Trade Shares of ProShares
Short VIX Short-Term Futures ETF, ProShares Short VIX Mid-Term Futures
ETF, ProShares Ultra VIX Short-Term Futures ETF, ProShares Ultra VIX
Mid-Term Futures ETF, ProShares UltraShort VIX Short-Term Futures ETF,
and ProShares UltraShort VIX Mid-Term Futures ETF Under NYSE Arca
Equities Rule 8.200, Commentary .02

August 15, 2011.

I. Introduction

    On April 28, 2011, NYSE Arca, Inc. (``Exchange'' or ``NYSE Arca'')
filed with the Securities and Exchange Commission (``Commission''),
pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ a proposed rule change to
list and trade shares (``Shares'') of ProShares Short VIX Short-Term
Futures ETF, ProShares Short VIX Mid-Term Futures ETF (``Short
Funds''), ProShares Ultra VIX Short-Term Futures ETF, ProShares Ultra
VIX Mid-Term Futures ETF (``Ultra Funds''), ProShares UltraShort VIX
Short-Term Futures ETF, and ProShares UltraShort VIX Mid-Term Futures
ETF (``UltraShort Funds'' and, together with the Short Funds and Ultra
Funds, the ``Funds'') under NYSE Arca Equities Rule 8.200, Commentary
.02. The proposed rule change was published in the Federal Register on
May 17, 2011.\3\ The Commission received no comments on the proposal.
On July 1, 2011, the Exchange submitted a request to extend the
Commission's action date for the proposed rule change to August 15,
2011. This order grants approval of the proposed rule change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 64470 (May 11,
2011), 76 FR 28493 (``Notice'').
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II. Description of the Proposal

    The Exchange proposes to list and trade the Shares pursuant to NYSE
Arca Equities Rule 8.200, Commentary .02, which permits the trading of
Trust Issued Receipts. ProShare Capital Management LLC (``Sponsor''), a
Maryland limited liability company, serves as the Sponsor of ProShares
Trust II (``Trust'') and is a commodity pool operator and commodity
trading advisor.\4\ Brown Brothers Harriman & Co. serves as the
administrator (``Administrator''), custodian, and transfer agent of the
Funds and their respective Shares. SEI Investments Distribution Co.
serves as Distributor of the Shares. Wilmington Trust Company, a
Delaware banking corporation, is the sole trustee of the Trust.
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    \4\ The Funds have filed a registration statement on Form S-3
under the Securities Act of 1933. See Post-Effective Amendment No. 4
dated April 13, 2011 (File No. 333-163511) to the Trust's
Registration Statement on Form S-3 (``Registration Statement'').
---------------------------------------------------------------------------

    The Funds seek, on a daily basis, to provide investment results
(before fees and expenses) that correspond to the inverse of the daily
performance, a multiple of the daily performance, or an inverse
multiple of the daily performance of a benchmark that seeks to offer
exposure to market volatility through publicly traded futures markets.
The benchmark for ProShares Short VIX Short-Term Futures ETF, ProShares
Ultra VIX Short-Term Futures ETF, and ProShares UltraShort VIX Short-
Term Futures ETF is the S&P 500 VIX Short-Term Futures Index, and the
benchmark for ProShares Short VIX Mid-Term Futures ETF, ProShares Ultra
VIX Mid-Term Futures ETF, and ProShares UltraShort VIX Mid-Term Futures
ETF is the S&P 500 VIX Mid-Term Futures Index (each, an ``Index,'' and,
collectively, the ``Indexes'').\5\ The Funds will take long (in the
case of the Ultra Funds) and short (in the case of the Short and
UltraShort Funds) positions in futures contracts based on the Chicago
Board Options Exchange (``CBOE'') Volatility Index (``VIX'') and, under
limited circumstances, swap agreements (as described below), to pursue
their respective investment objectives. Each Fund also may invest in
cash or cash equivalents such as U.S. Treasury securities or other high
credit quality short-term fixed-income, or similar securities that may
serve as collateral for the futures contracts and swap agreements.
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    \5\ Standard & Poor's Financial Services LLC, the index sponsor
with respect to the Indexes, is not a broker-dealer and has
implemented procedures designed to prevent the use and dissemination
of material, non-public information regarding the Indexes.
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    Specifically, each Fund seeks to achieve its investment objective
by investing under normal market conditions \6\ in VIX futures
contracts traded on the CBOE Futures Exchange (``CFE'') (``VIX Futures
Contracts'') such that each Fund has exposure intended to approximate
the inverse of the daily performance, a multiple of the daily
performance, or an inverse multiple of the daily performance of its
respective Index at the time of the net asset value (``NAV'')
calculation. In the event position accountability rules are reached
with respect to VIX Futures Contracts, the Sponsor may, in its
commercially reasonable judgment, cause such Fund to obtain exposure
through swaps referencing the relevant Index or particular VIX Futures
Contracts, or invest in other futures contracts or swaps not based on
the particular VIX Futures Contracts if such instruments tend to
exhibit trading prices or returns that correlate with the Indexes or
any VIX Futures Contract and will further the investment objective of
such Fund.\7\ The Funds may also invest in swaps if the market for a
specific futures contract experiences emergencies or disruptions that
prevent a Fund from obtaining the appropriate amount of investment
exposure to the

affected VIX Futures Contracts directly or to other futures
contracts.\8\
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    \6\ The term ``under normal conditions'' includes, but is not
limited to, the absence of extreme volatility or trading halts in
the futures markets or the financial markets generally; operational
issues causing dissemination of inaccurate market information; or
force majeure type events such as systems failure, natural or man-
made disaster, act of God, armed conflict, act of terrorism, riot or
labor disruption or any similar intervening circumstance.
    \7\ To the extent practicable, the Funds will invest in swaps
cleared through the facilities of a centralized clearing house.
    \8\ The Sponsor will attempt to mitigate the Funds' credit risk
by transacting only with large, well-capitalized institutions using
measures designed to determine the creditworthiness of a
counterparty. The Sponsor will take various steps to limit
counterparty credit risk, as described in the Registration
Statement.
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    If the Short Funds are successful in meeting their objectives,
their values (before fees and expenses) should gain approximately as
much on a percentage basis as their respective Index when it declines
on a given day. Conversely, their values (before fees and expenses)
should lose approximately as much on a percentage basis as their
respective Index when it rises on a given day. If the Ultra Funds are
successful in meeting their objectives, their values (before fees and
expenses) should gain approximately twice as much on a percentage basis
as their respective Index when it rises on a given day. Conversely,
their values (before fees and expenses) should lose approximately twice
as much on a percentage basis as their respective Index when it
declines on a given day. If the UltraShort Funds are successful in
meeting their objectives, their values (before fees and expenses)
should gain approximately twice as much on a percentage basis as their
respective Index when it declines on a given day. Conversely, their
values (before fees and expenses) should lose approximately twice as
much on a percentage basis as their respective Index when it rises on a
given day.
    Each of the Funds uses investment techniques that include the use
of any one or a combination of VIX Futures Contracts and may, if
applicable, include swap agreements. The Funds' investment techniques
may involve a small investment relative to the amount of investment
exposure assumed and may result in losses exceeding the amounts
invested. Such techniques, particularly when used to create leverage,
may expose the Funds to potentially dramatic changes (losses or gains)
in the value of their investments and imperfect correlation between the
value of the investments and the security or Index.
    The Funds do not seek to achieve their stated investment objective
over a period of time greater than one day because mathematical
compounding prevents the Funds from perfectly achieving such results.
Accordingly, results over periods of time greater than one day
typically will not be a simple inverse correlation (-100%), multiple
correlation (+200%), or multiple inverse correlation (-200%) of the
period return of the corresponding Index and may differ significantly.
    Each Fund is not actively managed by traditional methods, which
typically involve effecting changes in the composition of a portfolio
on the basis of judgments relating to economic, financial, and market
considerations with a view toward obtaining positive results under all
market conditions. Rather, the Sponsor will seek to cause the NAV to
track the inverse of the daily performance, a multiple of the daily
performance, or an inverse multiple of the daily performance of an
Index, even during periods in which the benchmark is flat or moving in
a manner which causes the NAV of a Fund to decline. The Sponsor will
use a mathematical approach to determine the type, quantity, and mix of
investment positions that it believes should produce returns consistent
with each Fund's objective. The Sponsor will rely upon a pre-determined
model to generate orders that result in repositioning the Funds'
investments in accordance with their respective investment objectives.

VIX Futures Contracts

    The Indexes are comprised of, and the value of the Funds will be
based on, VIX Futures Contracts. VIX Futures Contracts are measures of
the market's expectation of the level of the VIX at certain points in
the future and will behave differently than current or spot VIX
values.\9\ The Funds are not linked to the VIX, and in many cases the
Indexes, and by extension the Funds, could significantly underperform
or outperform the VIX. While the VIX represents a measure of the
current expected volatility of the S&P 500 over the next 30 days, the
prices of VIX Futures Contracts are based on the current expectation of
what the expected 30-day volatility will be at a particular time in the
future (on the expiration date). The VIX Futures Contracts trade from
8:20 a.m. Eastern Time (``E.T.'') to 4:15 p.m. E.T.
---------------------------------------------------------------------------

    \9\ VIX is the ticker symbol for the CBOE Volatility Index, a
popular measure of implied volatility. According to the Registration
Statement, the goal of the VIX is to estimate the implied volatility
of the S&P 500 over the next 30 days. A relatively high level of the
VIX corresponds to a more volatile U.S. equity market as expressed
by more costly options on the S&P 500 Index. The VIX represents one
measure of the market's expectation of the volatility over the next
30 day period. It is a composite value of options on the S&P 500
Index. The formula used to calculate the composite value utilizes
current market prices for a series of out-of-the-money calls and
puts for the front month and second month expirations.
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The Indexes

    The Indexes act as a measure of volatility as reflected by the
price of certain VIX Futures Contracts (``Index Components''), with the
price of each VIX Futures Contract reflecting the market's expectation
of future volatility. Each Index seeks to reflect the returns that are
potentially available from holding an unleveraged long position in
certain VIX Futures Contracts. Unlike the Indexes, the VIX, which is
not a benchmark for any Fund, is calculated based on the prices of put
and call options on the S&P 500, which are traded on the CBOE.
    The S&P 500 VIX Short-Term Futures Index employs rules for
selecting the Index Components and a formula to calculate a level for
the Index from the prices of these components. Specifically, the Index
Components represent the prices of the two near-term VIX futures
months, replicating a position that rolls the nearest month VIX Futures
Contract to the next month VIX Futures Contract on a daily basis in
equal fractional amounts. This results in a constant weighted average
maturity of one month. The roll period begins on the Tuesday prior to
the monthly VIX Futures Contracts settlement date and runs through the
Tuesday prior to the subsequent month's VIX Futures Contract settlement
date.
    The S&P 500 VIX Mid-Term Futures Index also employs rules for
selecting the Index Components and a formula to calculate the level of
the Index from the prices of these components. Specifically, the Index
Components represent the prices for four contract months of VIX Futures
Contracts, representing a market-based estimation of constant maturity,
five month forward implied VIX values. The S&P 500 VIX Mid-Term Futures
Index measures the return from a rolling long position in the fourth,
fifth, sixth and seventh month VIX Futures Contracts and rolls
continuously throughout each month while maintaining positions in the
fifth and sixth month contracts. This results in a constant weighted
average maturity of five months.
    Because the Indexes incorporate the process of rolling futures
positions on a daily basis, and the Funds, in general, also roll their
positions on a daily basis, the daily roll is not anticipated to be a
significant source of tracking error between a Fund and its respective
Index. The Indexes are based on VIX Futures Contracts and not the VIX,
and as such neither the Funds nor the Indexes are expected to track the
VIX. The level of each Index is calculated in accordance with the
method described

in the Registration Statement and will be published at least every 15
seconds both in real time from 9:30 a.m. to 4:15 p.m. E.T. and at the
close of trading on each Business Day by Bloomberg L.P. and
Reuters.\10\
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    \10\ A ``Business Day'' means any day other than a day when any
of the NYSE, NYSE Arca, CBOE, or CFE or other exchange material to
the valuation or operation of the Funds, or the calculation of the
VIX, options contracts underlying the VIX, VIX Futures Contracts, or
the Indexes is closed for trading.
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    Additional information regarding the Funds and the Shares,
investment strategies, risks, creation and redemption procedures,
Indexes, VIX Futures Contracts, calculation and dissemination of NAV,
fees, portfolio holdings, disclosure policies, distributions and taxes,
availability of information, trading rules and halts, and surveillance
procedures, among other things, can be found in the Notice and
Registration Statement, as applicable.\11\
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    \11\ See Notice and Registration Statement, supra notes 3 and 4,
respectively.
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III. Discussion and Commission's Findings

    The Commission has carefully reviewed the proposed rule change and
finds that it is consistent with the requirements of Section 6 of the
Act \12\ and the rules and regulations thereunder applicable to a
national securities exchange.\13\ In particular, the Commission finds
that the proposal is consistent with Section 6(b)(5) of the Act,\14\
which requires, among other things, that the Exchange's rules be
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. The Commission notes that the Shares must comply with
the requirements of NYSE Arca Equities Rule 8.200 and Commentary .02
thereto to be listed and traded on the Exchange.
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    \12\ 15 U.S.C. 78f.
    \13\ In approving this proposed rule change, the Commission
notes that it has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
    \14\ 15 U.S.C. 78f(b)(5).
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    The Commission finds that the proposal to list and trade the Shares
on the Exchange is consistent with Section 11A(a)(1)(C)(iii) of the
Act,\15\ which sets forth Congress' finding that it is in the public
interest and appropriate for the protection of investors and the
maintenance of fair and orderly markets to assure the availability to
brokers, dealers, and investors of information with respect to
quotations for and transactions in securities. Quotation and last-sale
information regarding the Shares will be disseminated through the
facilities of the Consolidated Tape Association. The level of each
Index will be published at least every 15 seconds both in real time
from 9:30 a.m. to 4:15 p.m. E.T. and at the close of trading on each
Business Day by Bloomberg L.P. and Reuters. In addition, an updated
Indicative Optimized Portfolio Value (``IOPV''), which is an indicator
of the value of the VIX Futures Contracts and cash and/or cash
equivalents less liabilities of a Fund, will be calculated. NYSE Arca
will calculate and disseminate every 15 seconds throughout the NYSE
Arca Core Trading Session (9:30 a.m. to 4 p.m. E.T.) an updated IOPV.
The IOPV will be published on the NYSE Arca's Web site and be available
through on-line information services such as Bloomberg and Reuters.
Further, the Funds will provide Web site disclosure of portfolio
holdings daily and will include, as applicable, the notional value (in
U.S. dollars) of VIX Futures Contracts, other financial instruments, if
any, cash equivalents, and amount of cash held in the portfolio of the
Funds. The intra-day, closing, and settlement prices of the Index
Components are also readily available from the Web sites of the CFE
(http://www.cfe.cboe.com), automated quotation systems, published or
other public sources, or on-line information services such as Bloomberg
or Reuters. The specific contract specifications for component futures
underlying the Indexes are also available on such websites, as well as
other financial informational sources. The CFE also provides delayed
futures information on current and past trading sessions and market
news free of charge on its Web site. The NAV for each Fund will be
calculated by the Administrator once a day at 4:15 p.m. E.T. The
Exchange will make available on its Web site daily trading volume of
each of the Shares, closing prices of such Shares, and number of Shares
outstanding. The Funds' Web site, http://www.proshares.com, will
display the end of day closing Index levels and NAV.
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78k-1(a)(1)(C)(iii).
---------------------------------------------------------------------------

    The Commission further believes that the proposal to list and trade
the Shares is reasonably designed to promote fair disclosure of
information that may be necessary to price the Shares appropriately and
to prevent trading when a reasonable degree of transparency cannot be
assured. The Commission notes that Web site disclosure of the portfolio
composition of the Funds will occur at the same time as the disclosure
by the Funds of the portfolio composition to Authorized Participants so
that all market participants are provided portfolio composition
information at the same time. In addition, if the Exchange becomes
aware that the NAV with respect to the Shares is not disseminated to
all market participants at the same time, the Exchange will halt
trading in the Shares until such time as the NAV is available to all
market participants. Further, the Exchange may halt trading during the
day in which an interruption to the dissemination of the IOPV, the
value of an Index, the VIX, or the value of the underlying VIX Futures
Contracts occurs. If an interruption to the dissemination of the IOPV,
the value of an Index, the VIX, or the value of the underlying VIX
Futures Contracts persists past the trading day in which it occurred,
the Exchange will halt trading no later than the beginning of the
trading day following the interruption.\16\ Trading in the Shares will
be subject to NYSE Arca Equities Rule 8.200, Commentary .02(e), which
sets forth certain restrictions on Equity Trading Permit (``ETP'')
Holders acting as registered Market Makers in Trust Issued Receipts to
facilitate surveillance. The Exchange represents that Standard & Poor's
Financial Services LLC, the index sponsor with respect to the Indexes,
is not a broker-dealer and has implemented procedures designed to
prevent the use and dissemination of material, non-public information
regarding the Indexes.
---------------------------------------------------------------------------

    \16\ Trading may also be halted because of market conditions or
for reasons that, in the view of the Exchange, make trading in the
Shares inadvisable. These may include: (1) The extent to which
trading is not occurring in the underlying futures contracts; or (2)
whether other unusual conditions or circumstances detrimental to the
maintenance of a fair and orderly market are present.
---------------------------------------------------------------------------

    The Exchange further represents that the Shares are deemed to be
equity securities subject to the Exchange's existing rules governing
the trading of equity securities. In support of this proposal, the
Exchange has made additional representations, including:
    (1) The Funds will meet the initial and continued listing
requirements applicable to Trust Issued Receipts in NYSE Arca Equities
Rule 8.200 and Commentary .02 thereto.
    (2) The Exchange has appropriate rules to facilitate transactions
in the Shares during all trading sessions.
    (3) The Exchange's surveillance procedures are adequate to properly
monitor Exchange trading of the Shares in all trading sessions and to
deter and detect violations of Exchange rules and applicable federal
securities laws. In

addition, with respect to any Fund's holdings of futures contracts
traded on exchanges, not more than 10% of the weight of such futures
contracts in the aggregate shall consist of components whose principal
trading market is not a member of the Intermarket Surveillance Group or
is a market with which the Exchange does not have a comprehensive
surveillance sharing agreement.
    (4) Prior to the commencement of trading, the Exchange will inform
its ETP Holders of the suitability requirements of NYSE Arca Equities
Rule 9.2(a) in an Information Bulletin. Specifically, ETP Holders will
be reminded in the Information Bulletin that, in recommending
transactions in the Shares, they must have a reasonable basis to
believe that (a) the recommendation is suitable for a customer given
reasonable inquiry concerning the customer's investment objectives,
financial situation, needs, and any other information known by such
member, and (b) the customer can evaluate the special characteristics,
and is able to bear the financial risks, of an investment in the
Shares. In connection with the suitability obligation, the Information
Bulletin will also provide that members must make reasonable efforts to
obtain the following information: (i) The customer's financial status;
(ii) the customer's tax status; (iii) the customer's investment
objectives; and (iv) such other information used or considered to be
reasonable by such member or registered representative in making
recommendations to the customer. In addition, the Information Bulletin
will reference the FINRA Regulatory Notices regarding sales practice
and customer margin requirements implemented by FINRA, applicable to
FINRA members, with respect to leveraged ETFs (which include the
Shares) and options on leveraged ETFs.\17\ ETP Holders that carry
customer accounts will be required to follow the FINRA guidance set
forth in these notices.
---------------------------------------------------------------------------

    \17\ See FINRA Regulatory Notices 09-31 (June 2009), 09-53
(August 2009) and 09-65 (November 2009) (``FINRA Regulatory
Notices'').
---------------------------------------------------------------------------

    (5) Prior to the commencement of trading, the Exchange also will
inform its ETP Holders in an Information Bulletin of the special
characteristics and risks associated with trading the Shares.
Specifically, the Information Bulletin will discuss the following: (a)
The risks involved in trading the Shares during the Opening and Late
Trading Sessions when an updated IOPV will not be calculated or
publicly disseminated; (b) the procedures for purchases and redemptions
of Shares in Creation Baskets and Redemption Baskets (and that Shares
are not individually redeemable); (c) NYSE Arca Equities Rule 9.2(a),
which imposes a duty of due diligence on its ETP Holders to learn the
essential facts relating to every customer prior to trading the Shares;
(d) the requirement that ETP Holders deliver a prospectus to investors
purchasing newly issued Shares prior to or concurrently with the
confirmation of a transaction; and (e) trading information.\18\
---------------------------------------------------------------------------

    \18\ As noted above, the Information Bulletin will further
advise ETP Holders that FINRA has implemented increased customer
margin requirements applicable to leveraged ETFs (which include the
Shares) and options on leveraged ETFs, as discussed in the FINRA
Regulatory Notices. See supra, note 17.
---------------------------------------------------------------------------

    (6) The Funds must be in compliance with NYSE Arca Equities Rule
5.3 and Rule 10A-3 under the Act.\19\
---------------------------------------------------------------------------

    \19\ 17 CFR 240.10A-3.
---------------------------------------------------------------------------

    (7) A minimum of 100,000 Shares for each Fund will be outstanding
as of the start of trading on the Exchange.
    This approval order is based on the Exchange's representations.\20\
---------------------------------------------------------------------------

    \20\ The Commission notes that it does not regulate the market
for futures in which the Fund plans to take positions, which is the
responsibility of the Commodity Futures Trading Commission
(``CFTC''). The CFTC has the authority to set limits on the
positions that any person may take in futures. These limits may be
directly set by the CFTC or by the markets on which the futures are
traded. The Commission has no role in establishing position limits
on futures, even though such limits could impact an exchange-traded
product that is under the jurisdiction of the Commission.
---------------------------------------------------------------------------

    For the foregoing reasons, the Commission finds that the proposed
rule change is consistent with Section 6(b)(5) of the Act \21\ and the
rules and regulations thereunder applicable to a national securities
exchange.
---------------------------------------------------------------------------

    \21\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

IV. Conclusion

    It is therfore ordered, pursuant to Section 19(b)(2) of the
Act,\22\ that the proposed rule change (SR-NYSEArca-2011-23) be, and it
hereby is, approved.
---------------------------------------------------------------------------

    \22\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\23\
---------------------------------------------------------------------------

    \23\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-21173 Filed 8-18-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: June 19, 2008 (Volume 73, Number 119)]
[Notices]
[Page 34926-34927]
[DOCID:fr19jn08-57]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2008-0150; FRL-8683-1]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; Establishing No-Discharge Zones
Under Clean Water Act Section 312 (Renewal), EPA ICR Number 1791.05,
OMB Control Number 2040-0187

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.), this document announces that an Information Collection
Request (ICR) has been forwarded to the Office of Management and Budget
(OMB) for review and approval. This is a request to renew an existing
approved collection. The ICR, which is abstracted below, describes the
nature of the information collection and its estimated burden and cost.

DATES: Additional comments may be submitted on or before July 21, 2008.

ADDRESSES: Submit your comments, referencing docket ID number EPA-HQ-
OW-2008-0150, to (1) EPA online using http://www.regulations.gov (our
preferred method), or by e-mail to<EMAIL_ADDRESS>or by mail to:
EPA Docket Center, Environmental Protection Agency, Office of Water
Docket, mail code 28221T, 1200 Pennsylvania Ave., NW., Washington,

DC 20460, and (2) OMB at: Office of Information and Regulatory Affairs,
Office of Management and Budget (OMB), Attention: Desk Officer for EPA,
725 17th Street, NW., Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Chris Laabs, Office of Water, 4504T,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number: 202-
566-1546; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On March 25, 2008 (73 FR 15752), EPA sought comments on this
ICR pursuant to 5 CFR 1320.8(d). EPA received no comments. Any
additional comments on this ICR should be submitted to EPA and OMB
within 30 days of this notice.
    EPA has established a public docket for this ICR under Docket ID
No. EPA-HQ-OW-2008-0150, which is available for viewing at the http://
www.regulations.gov, or in person viewing at the Water Docket in the
EPA Docket Center (EPA/DC), 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 Reading Room is (202) 566-
1744, and the telephone number for the Water Docket is<PHONE_NUMBER>.
    Use EPA's electronic docket and comment system at http://
www.regulations.gov, to submit or view public comments, access the
index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above. Please note that EPA's policy is that public
comments, whether submitted electronically or in paper, will be made
available for public viewing at http://www.regulations.gov as EPA
receives them and without change, unless the comment contains
copyrighted material, Confidential Business Information (CBI), or other
information whose public disclosure is restricted by statute. For
further information about the electronic docket, go to http://
www.regulations.gov.
    Title: Establishing No-Discharge Zones Under Clean Water Act
Section 312 (Renewal).
    ICR numbers: EPA ICR No. 1791.05, OMB Control No. 2040-0187.
    ICR Status: This ICR is scheduled to expire on June 30, 2008. Under
OMB regulations, the Agency may continue to conduct or sponsor the
collection of information while this submission is pending at OMB. The
OMB control numbers for EPA's regulations in title 40 of the CFR, after
appearing in the Federal Register when approved, are listed in 40 CFR
part 9, are displayed either by publication in the Federal Register or
by other appropriate means, such as on the related collection
instrument or form, if applicable. The display of OMB control numbers
in certain EPA regulations is consolidated in 40 CFR part 9.
    Abstract: (A) Sewage No-discharge Zones: The need for EPA to obtain
information for the establishment of no-discharge zones (NDZs) for
vessel sewage in State waters stems from CWA Section 312(f)(3),
(f)(4)(A), and (f)(4)(B), and subsequent regulations at 40 CFR 140.4(a-
c). NDZs are established to provide State and local governments with
additional protection of waters from treated or untreated vessel
sewage. There are 3 ways in which NDZs for vessel sewage can be
established. This ICR discusses the information requirements associated
with the establishment of NDZs for vessel sewage. The responses to this
collection of information are required to obtain the benefit of a
sewage NDZ (see 33 U.S.C. 1322). The information collection activities
discussed in this ICR do not require the submission of any confidential
information. (B) UNDS No-discharge Zones: Under section 312(n) of the
Clean Water Act (``Uniform National Discharge Standards for Vessels of
the Armed Forces'' or ``UNDS'') NDZs for discharges from Armed Forces
vessels may be established by either State prohibition or EPA
prohibition following the procedures in 40 CFR Part 1700. UNDS also
provides that the Governor of any State may petition EPA and the
Secretary of Defense to review any determination or standard
promulgated under the UNDS program if there is significant new
information that could reasonably result in a change to the
determination or standard. This ICR discusses the information that will
be required from a State if it decides to establish a NDZ by State
prohibition or apply for a NDZ by EPA prohibition, and the information
that will be required from a State if it decides to submit a petition
for review. The responses to this collection of information are
required to obtain the benefit of an UNDS NDZ or a review of an UNDS
determination or standard (see 33 U.S.C. 1322(n)). The information
collection activities discussed in this ICR do not require the
submission of any confidential information.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 127
hours per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    Respondents/Affected Entities: Entities potentially affected by
this action are state, local, and tribal governments.
    Estimated Number of Respondents: 16.
    Frequency of Response: On occasion.
    Estimated Total Annual Hour Burden: 2,207 hours.
    Estimated Total Annual Cost: $100,820 includes $2,300 annualized
capital or O&M costs and $98,520 labor costs.
    Changes in the Estimates: The total hourly estimated burden
currently identified in the OMB Inventory of Approved ICR Burdens
remains the same; however, the current ICR presents an increase in the
total cost due to normal cost inflation.

    Dated: June 11, 2008.
Sara Hisel-McCoy,
Director, Collection Strategies Division.
 [FR Doc. E8-13889 Filed 6-18-08; 8:45 am]

BILLING CODE 6560-50-P


Baseline 208.4 282.0 260.1 194.9 231.1 T 1 ( 1 hr) 754.6 972.6 874.1 1,698.3 1,980.9 T 2 ( 2 hr) 1,000.6 1,323.5 1,202.4 2,079.4 2,538.5 T 3 ( 3 hr) 1,282.3 1,484.8 1,418.6 2,461.7 2,854.6 T 4 ( 4 hr) 1,543.1 1,628.7 1,691.5 2,397.0 2,952.4 Table 126. Standard Deviations of LDH concentration ( mU/ mg) by Vehicle Concentration No hCG Stimulation Timepoint 0.0% 0.5% 1.0% 5.0% 10.0%

Baseline 30.6 64.3 38.8 95.1 133.0 T 1 ( 1 hr) 305.2 409.8 317.9 811.4 1,612.1 T 2 ( 2 hr) 356.7 532.5 387.8 1,009.3 1,777.8 T 3 ( 3 hr) 323.2 429.9 401.5 1,281.2 1,618.7 T 4 ( 4 hr) 198.5 428.9 406.7 784.9 1,379.3 37 Table 127. Sample sizes of LDH Concentration ( mU/ mg) by Vehicle Concentration No hCG Stimulation Timepoint 0.0% 0.5% 1.0% 5.0% 10.0%

Baseline 3 3 3 3 3 T 1 ( 1 hr) 3 3 3 3 3 T 2 ( 2 hr) 3 3 3 3 3 T 3 ( 3 hr) 3 3 3 3 3 T 4 ( 4 hr) 3 3 3 3 3 Table 128. Coeff of Variation of LDH Concentration ( mU/ mg) by Vehicle Concentration No hCG Stimulation Timepoint 0.0% 0.5% 1.0% 5.0% 10.0%

Baseline 14.7 22.8 14.9 48.8 57.6 T 1 ( 1 hr) 40.4 42.1 36.4 47.8 81.4 T 2 ( 2 hr) 35.7 40.2 32.3 48.5 70.0 T 3 ( 3 hr) 25.2 29.0 28.3 52.0 56.7 T 4 ( 4 hr) 12.9 26.3 24.0 32.7 46.7 38 Table 129. Means of LDH Concentration ( mU/ mg) by Vehicle Type with hCG Stimulation Timepoint DMSO ETOH Tween Baseline 247.1 237.0 169.0 T 1 ( 1 hr) 1,018.8 739.8 1,621.3 T 2 ( 2 hr) 1,414.4 968.4 2,824.4 T 3 ( 3 hr) 1,743.2 1,172.4 3,098.1 T 4 ( 4 hr) 2,058.8 1,368.4 3,226.2 Table 130. Standard Deviations of LDH Concentration ( mU/ mg) by Vehicle Type with hCG Stimulation Timepoint DMSO ETOH Tween Baseline 146.9 56.3 75.4 T 1 ( 1 hr) 257.6 122.6 1,000.8 T 2 ( 2 hr) 170.9 149.3 1,943.9 T 3 ( 3 hr) 354.2 149.5 1,812.5 T 4 ( 4 hr) 541.3 195.9 1,652.0 Section 14.0 VEHICLE EFFECT EXPERIMENT 39 Table 131. Sample sizes of LDH Concentration ( mU/ mg) by Vehicle Type with hCG Stimulation Timepoint DMSO ETOH Tween Baseline 5 5 5 T 1 ( 1 hr) 5 5 5 T 2 ( 2 hr) 5 5 5 T 3 ( 3 hr) 5 5 5 T 4 ( 4 hr) 5 5 5 Table 132. Coeff of Variation of LDH Concentration ( mU/ mg) by Vehicle Type with hCG Stimulation Timepoint DMSO ETOH Tween Baseline 59.5 23.8 44.6 T 1 ( 1 hr) 25.3 16.6 61.7 T 2 ( 2 hr) 12.1 15.4 68.8 T 3 ( 3 hr) 20.3 12.8 58.5 T 4 ( 4 hr) 26.3 14.3 51.2 40 Table 133. Means of LDH Concentration ( mU/ mg) by Vehicle Concentration with hCG Stimulation Timepoint 0.0% 0.5% 1.0% 5.0% 10.0%

Baseline 321.7 178.5 286.8 144.6 156.9 T 1 ( 1 hr) 986.0 928.5 861.9 1,416.7 1,440.3 T 2 ( 2 hr) 1,311.5 1,341.7 1,201.6 2,539.5 2,284.4 T 3 ( 3 hr) 1,614.0 1,564.7 1,402.6 2,777.1 2,664.5 T 4 ( 4 hr) 1,750.5 1,822.9 1,615.5 2,955.0 2,945.3 Table 134. Standard Deviations of LDH Concentration ( mU/ mg) by Vehicle Concentration with hCG Stimulation Timepoint 0.0% 0.5% 1.0% 5.0% 10.0%

Baseline 145.1 35.5 45.3 46.2 64.4 T 1 ( 1 hr) 376.4 66.0 276.8 964.6 1,249.2 T 2 ( 2 hr) 340.2 229.8 395.9 2,534.4 1,803.9 T 3 ( 3 hr) 399.6 258.0 404.3 2,500.2 1,582.9 T 4 ( 4 hr) 389.8 256.9 477.6 2,285.5 1,464.8 Section 14.0 VEHICLE EFFECT EXPERIMENT 41 Table 135. Sample sizes of LDH Concentration ( mU/ mg) by Vehicle Concentration with hCG Stimulation Timepoint 0.0% 0.5% 1.0% 5.0% 10.0%

Baseline 3 3 3 3 3 T 1 ( 1 hr) 3 3 3 3 3 T 2 ( 2 hr) 3 3 3 3 3 T 3 ( 3 hr) 3 3 3 3 3 T 4 ( 4 hr) 3 3 3 3 3 Table 136. Coeff of Variation of LDH Concentration ( mU/ mg) by Vehicle Concentration with hCG Stimulation Timepoint 0.0% 0.5% 1.0% 5.0% 10.0%

Baseline 45.1 19.9 15.8 31.9 41.0 T 1 ( 1 hr) 38.2 7.1 32.1 68.1 86.7 T 2 ( 2 hr) 25.9 17.1 32.9 99.8 79.0 T 3 ( 3 hr) 24.8 16.5 28.8 90.0 59.4 T 4 ( 4 hr) 22.3 14.1 29.6 77.3 49.7 42 Table 137. Means of Testosterone Concentration ( ng/ mg) by Vehicle Type No hCG Stimulation Timepoint DMSO ETOH Tween Baseline 0.0025 0.0025 0.0023 T 1 ( 1 hr) 0.0219 0.0162 0.0346 T 2 ( 2 hr) 0.0257 0.0218 0.0315 T 3 ( 3 hr) 0.0243 0.0262 0.0312 T 4 ( 4 hr) 0.0229 0.0275 0.0226 Table 138. Standard Deviations of Testosterone Concentration ( ng/ mg) by Vehicle Type No hCG Stimulation Timepoint DMSO ETOH Tween Baseline 0.0006 0.0004 0.0003 T 1 ( 1 hr) 0.0024 0.0042 0.0165 T 2 ( 2 hr) 0.0026 0.0106 0.0155 T 3 ( 3 hr) 0.0032 0.0171 0.0163 T 4 ( 4 hr) 0.0045 0.0225 0.0084 Section 14.0 VEHICLE EFFECT EXPERIMENT 43 Table 139. Sample sizes of Testosterone Concentration ( ng/ mg) by Vehicle Type No hCG Stimulation Timepoint DMSO ETOH Tween Baseline 5 5 5 T 1 ( 1 hr) 5 5 5 T 2 ( 2 hr) 5 5 5 T 3 ( 3 hr) 5 5 5 T 4 ( 4 hr) 5 5 5 Table 140. Coeff of Variation of Testosterone Concentration ( ng/ mg) by Vehicle Type No hCG Stimulation Timepoint DMSO ETOH Tween Baseline 25.4 15.9 12.3 T 1 ( 1 hr) 11.0 26.1 47.7 T 2 ( 2 hr) 10.1 48.4 49.3 T 3 ( 3 hr) 13.0 65.0 52.1 T 4 ( 4 hr) 19.7 81.7 37.2 44 Table 141. Means of Testosterone Concentration ( ng/ mg) by Vehicle Concentration No hCG Stimulation Timepoint 0.0% 0.5% 1.0% 5.0% 10.0%

Baseline 0.0026 0.0025 0.0025 0.0020 0.0026 T 1 ( 1 hr) 0.0258 0.0191 0.0197 0.0235 0.0332 T 2 ( 2 hr) 0.0334 0.0198 0.0250 0.0221 0.0314 T 3 ( 3 hr) 0.0391 0.0205 0.0237 0.0220 0.0309 T 4 ( 4 hr) 0.0420 0.0192 0.0191 0.0219 0.0195 Table 142. Standard Deviations of Testosterone Concentration ( ng/ mg) by Vehicle Concentration No hCG Stimulation Timepoint 0.0% 0.5% 1.0% 5.0% 10.0%

Baseline 0.0004 0.0007 0.0004 0.0005 0.0003 T 1 ( 1 hr) 0.0033 0.0046 0.0034 0.0111 0.0260 T 2 ( 2 hr) 0.0067 0.0044 0.0025 0.0074 0.0224 T 3 ( 3 hr) 0.0152 0.0034 0.0020 0.0061 0.0235 T 4 ( 4 hr) 0.0221 0.0048 0.0043 0.0084 0.0063 Section 14.0 VEHICLE EFFECT EXPERIMENT 45 Table 143. Sample sizes of Testosterone Concentration ( ng/ mg) by Vehicle Concentration No hCG Stimulation Timepoint 0.0% 0.5% 1.0% 5.0% 10.0%

Baseline 3 3 3 3 3 T 1 ( 1 hr) 3 3 3 3 3 T 2 ( 2 hr) 3 3 3 3 3 T 3 ( 3 hr) 3 3 3 3 3 T 4 ( 4 hr) 3 3 3 3 3 Table 144. Coeff of Variation of Testosterone Concentration ( ng/ mg) by Vehicle Concentration No hCG Stimulation Timepoint 0.0% 0.5% 1.0% 5.0% 10.0%

Baseline 17.4 25.6 14.3 24.4 11.5 T 1 ( 1 hr) 12.8 24.0 17.4 47.3 78.4 T 2 ( 2 hr) 20.1 22.4 10.1 33.6 71.2 T 3 ( 3 hr) 38.9 16.7 8.2 27.7 75.9 T 4 ( 4 hr) 52.6 24.7 22.3 38.3 32.3 46 Table 145. Means of Testosterone Concentration ( ng/ mg) by Vehicle Type with hCG Stimulation Timepoint DMSO ETOH Tween Baseline 0.0032 0.0025 0.0023 T 1 ( 1 hr) 0.0270 0.0189 0.0432 T 2 ( 2 hr) 0.0427 0.0304 0.0585 T 3 ( 3 hr) 0.0581 0.0452 0.0623 T 4 ( 4 hr) 0.0850 0.0633 0.0708 Table 146. Standard Deviations of Testosterone Concentration ( ng/ mg) by Vehicle Type with hCG Stimulation Timepoint DMSO ETOH Tween Baseline 0.0028 0.0005 0.0009 T 1 ( 1 hr) 0.0096 0.0024 0.0305 T 2 ( 2 hr) 0.0278 0.0089 0.0628 T 3 ( 3 hr) 0.0388 0.0172 0.0744 T 4 ( 4 hr) 0.0875 0.0328 0.0908 Section 14.0 VEHICLE EFFECT EXPERIMENT 47 Table 147. Sample sizes of Testosterone Concentration ( ng/ mg) by Vehicle Type with hCG Stimulation Timepoint DMSO ETOH Tween Baseline 5 5 5 T 1 ( 1 hr) 5 5 5 T 2 ( 2 hr) 5 5 5 T 3 ( 3 hr) 5 5 5 T 4 ( 4 hr) 5 5 5 Table 148. Coeff of Variation of Testosterone Concentration ( ng/ mg) by Vehicle Type with hCG Stimulation Timepoint DMSO ETOH Tween Baseline 85.8 21.6 37.2 T 1 ( 1 hr) 35.4 12.9 70.5 T 2 ( 2 hr) 65.1 29.4 107.3 T 3 ( 3 hr) 66.8 38.1 119.6 T 4 ( 4 hr) 103.0 51.9 128.3 48 Table 149. Means of Testosterone Concentration ( ng/ mg) by Vehicle Concentration with hCG Stimulation Timepoint 0.0% 0.5% 1.0% 5.0% 10.0%

Baseline 0.0046 0.0019 0.0026 0.0018 0.0025 T 1 ( 1 hr) 0.0356 0.0183 0.0265 0.0202 0.0478 T 2 ( 2 hr) 0.0734 0.0302 0.0490 0.0331 0.0336 T 3 ( 3 hr) 0.0858 0.0418 0.0657 0.0434 0.0393 T 4 ( 4 hr) 0.0992 0.0540 0.1062 0.0641 0.0416 Table 150. Standard Deviations of Testosterone Concentration ( ng/ mg) by Vehicle Concentration with hCG Stimulation Timepoint 0.0% 0.5% 1.0% 5.0% 10.0%

Baseline 0.0032 0.0002 0.0007 0.0005 0.0002 T 1 ( 1 hr) 0.0254 0.0015 0.0085 0.0034 0.0346 T 2 ( 2 hr) 0.0836 0.0098 0.0372 0.0053 0.0109 T 3 ( 3 hr) 0.0941 0.0206 0.0545 0.0171 0.0112 T 4 ( 4 hr) 0.1153 0.0296 0.1183 0.0384 0.0106 Section 14.0 VEHICLE EFFECT EXPERIMENT 49 Table 151. Sample sizes of Testosterone Concentration ( ng/ mg) by Vehicle Concentration with hCG Stimulation Timepoint 0.0% 0.5% 1.0% 5.0% 10.0%

Baseline 3 3 3 3 3 T 1 ( 1 hr) 3 3 3 3 3 T 2 ( 2 hr) 3 3 3 3 3 T 3 ( 3 hr) 3 3 3 3 3 T 4 ( 4 hr) 3 3 3 3 3 Table 152. Coeff of Variation of Testosterone Concentration ( ng/ mg) by Vehicle Concentration with hCG Stimulation Timepoint 0.0% 0.5% 1.0% 5.0% 10.0%

Baseline 70.1 10.8 27.2 28.7 7.8 T 1 ( 1 hr) 71.3 8.4 32.0 16.6 72.4 T 2 ( 2 hr) 113.8 32.3 76.0 16.0 32.5 T 3 ( 3 hr) 109.6 49.3 83.0 39.3 28.4 T 4 ( 4 hr) 116.2 54.8 111.4 59.9 25.4 Section 14.0 VEHICLE EFFECT EXPERIMENT 50 80 Table 153. Summary of Vehicle Experiment : LDH Concentrations* ( mU/ mg) by Vehicle Type**

Timepoint DMSO ETOH Tween 20 Baseline 237.1 + 58.4 264.0 + 66.4 204.8 + 102.6 1 hr 1,042.5 + 374.2 775.8 + 247.3 1,950.0 + 1,249.2 2 hr 1,399.8 + 568.7 1,075.0 + 312.5 2,411.9 + 1,417.4 3 hr 1,776.5 + 789.3 1,245.5 + 239.4 2,679.3 + 1,368.0 4 hr 2,080.7 + 850.5 1,434.3 + 161.9 2,612.6 + 978.1 * Mean + standard deviation ** No hCG stimulation occurred 81 Table 154. Summary of Vehicle Experiment : LDH Concentrations* ( mU/ mg) by Vehicle Type**

Timepoint DMSO ETOH Tween 20 Baseline 247.1 + 146.9 237.0 + 56.3 169.0 + 75.4 1 hr 1,018.8 + 257.6 739.8 + 122.6 1,621.3 + 1,000.8 2 hr 1,414.4 + 170.9 968.4 + 149.3 2,824.4 + 1,943.9 3 hr 1,743.2 + 354.2 1,172.4 + 149.5 3,098.1 + 1,812.5 4 hr 2,058.8 + 541.3 1,368.4 + 195.9 3,226.2 + 1,652.0 * Mean + standard deviation ** hCG stimulation occurred 82 Table 155. Summary of Vehicle Experiment : LDH Concentrations* ( mU/ mg) by Vehicle Concentration**

Timepoint 0.0% 0.5% 1.0% 5.0% 10.0%

Baseline 208.4 + 30.6 282.0 + 64.3 260.1 + 38.8 194.9 + 95.1 231.1 + 133.0 1 hr 754.5 + 305.2 972.6 + 409.8 874.1 + 317.9 1,698.3 + 811.4 1,980.9 + 1,612.1 2 hr 1,000.6 + 356.7 1,323.5 + 532.5 1,202.4 + 387.8 2,079.4 + 1,009.3 2,538.5 + 1,777.8 3 hr 1,282.3 + 323.2 1,484.8 + 429.9 1,418.6 + 401.5 2,461.7 + 1,281.2 2,854.6 + 1,618.7 4 hr 1,543.1 + 198.5 1,628.7 + 428.9 1,691.5 + 406.7 2,397.0 + 784.9 2,952.4 + 1,379.3 * Mean + standard deviation ** No hCG stimulation occurred 83 Table 156. Summary of Vehicle Experiment : LDH Concentrations* ( mU/ mg) by Vehicle Concentration**

Timepoint 0.0% 0.5% 1.0% 5.0% 10.0%

Baseline 321.7 + 145.1 178.5 + 35.5 286.8 + 45.3 144.6 + 46.2 156.9 + 64.4 1 hr 986.0 + 376.4 928.5 + 66.0 861.9 + 276.8 1,416.7 + 964.6 1,440.3 + 1,249.2 2 hr 1,311.5 + 340.2 1,341.7 + 229.8 1,201.6 + 395.9 2,539.5 + 2,534.4 2,284.4 + 1,803.9 3 hr 1,614.0 + 399.6 1,564.7 + 258.0 1,402.6 + 404.3 2,777.1 + 2,500.2 2,664.5 + 1,582.9 4 hr 1,750.5 + 389.8 1,822.9 + 256.9 1,615.5 + 477.6 2,955.0 + 2,285.5 2,945.3 + 1,464.8 * Mean + standard deviation ** hCG stimulation occurred 84 Table 157. Summary of Vehicle Experiment : Testosterone Concentrations* ( ng/ mg) by Vehicle Type**

Timepoint DMSO ETOH Tween 20 Baseline 0.0025 + 0.0006 0.0025 + 0.0004 0.0023 + 0.0003 1 hr 0.0219 + 0.0024 0.0162 + 0.0042 0.0346 + 0.0165 2 hr 0.0257 + 0.0026 0.0218 + 0.0106 0.0315 + 0.0155 3 hr 0.0243 + 0.0032 0.0262 + 0.0171 0.0312 + 0.0163 4 hr 0.0229 + 0.0045 0.0275 + 0.0225 0.0226 + 0.0084 * Mean + standard deviation ** No hCG stimulation occurred 85 Table 158. Summary of Vehicle Experiment : Testosterone Concentrations* ( ng/ mg) by Vehicle Type**

Timepoint DMSO ETOH Tween 20 Baseline 0.0032 + 0.0028 0.0025 + 0.0005 0.0023 + 0.0009 1 hr 0.0270 + 0.0096 0.0189 + 0.0024 0.0432 + 0.0305 2 hr 0.0427 + 0.0278 0.0304 + 0.0089 0.0585 + 0.0628 3 hr 0.0581 + 0.0388 0.0452 + 0.0172 0.0623 + 0.0744 4 hr 0.0850 + 0.0875 0.0633 + 0.0328 0.0708 + 0.0908 * Mean + standard deviation ** hCG stimulation occurred 86 Table 159. Summary of Vehicle Experiment : Testosterone Concentrations* ( ng/ mg) by Vehicle Concentration**

Timepoint 0.0% 0.5% 1.0% 5.0% 10.0%

Baseline 0.0026 + 0.0004 0.0025 + 0.0007 0.0025 + 0.0004 0.0020 + 0.0005 0.0026 + 0.0003 1 hr 0.0258 + 0.0033 0.0191 + 0.0046 0.0197 + 0.0034 0.0235 + 0.0111 0.0332 + 0.0260 2 hr 0.0334 + 0.0067 0.0198 + 0.0044 0.0250 + 0.0025 0.0221 + 0.0074 0.0314 + 0.0224 3 hr 0.0391 + 0.0152 0.0205 + 0.0034 0.0237 + 0.0020 0.0220 + 0.0061 0.0309 + 0.0235 4 hr 0.0420 + 0.0221 0.0192 + 0.0048 0.0191 + 0.0043 0.0219 + 0.0084 0.0195 + 0.0063 * Mean + standard deviation ** No hCG stimulation occurred 87 Table 160. Summary of Vehicle Experiment : Testosterone Concentrations* ( ng/ mg) by Vehicle Concentration**

Timepoint 0.0% 0.5% 1.0% 5.0% 10.0%

Baseline 0.0046 + 0.0032 0.0019 + 0.0002 0.0026 + 0.0007 0.0018 + 0.0005 0.0025 + 0.0002 1 hr 0.0356 + 0.0254 0.0189 + 0.0015 0.0265 + 0.0085 0.0202 + 0.0034 0.0478 + 0.0346 2 hr 0.0734 + 0.0836 0.0302 + 0.0098 0.0490 + 0.0372 0.0331 + 0.0053 0.0336 + 0.0109 3 hr 0.0858 + 0.0941 0.0418 + 0.0206 0.0657 + 0.0545 0.0434 + 0.0171 0.0393 + 0.0112 4 hr 0.0992 + 0.1153 0.0540 + 0.0296 0.1062 + 0.1183 0.0641 + 0.0384 0.0416 + 0.0106 * Mean + standard deviation ** hCG stimulation occurred 88 15.0 DISCUSSION 15.1. Incubation Factors Experiments The test tube results had smaller root mean squared errors ( RMSEs) than vial results both with and without hCG. This may be the result of the tissue not breaking up as much since there is less space for tissue: media interaction than in the vial. For the cases with no hCG, the shaker speed was the dominant factor. However, for situations with hCG, incubation volume and fragment size were important for the incubations in vials but shaker speed and incubation temperature also became important for test tubes.

Vials consistently resulted in higher testosterone levels than test tubes. The optimum values occurred at the extremes of the experimental regions in all cases. The optimum fragment size generally fell in the middle portion of its range. For vials, the optimal fragment size with no hCG was around 80 mg, while with hCG the optimal size was approximately 200 mg. Therefore it is felt that 100 175 mg of testicular tissue is a range that would be appropriate to use in the slice testis assay when vials are used. The fragment size for test tubes appeared to be optimal at 130 170 mg.

The optimal hCG concentration fell in the middle of the range of tested concentrations. Although that range was 0.05 0.08 for some cases, it was felt that the 0.1 concentration would be the most easily adapted for a screening assay. The concentration for hCG concentration in the assay has to be calculated for the final concentration in the volume of media to be used in each vial and the 0.1 concentration is more easily calculated and weighed for a general assay.

The optimal temperature fell between 34 and 37 ° C and was approximately 36 ° C . When shaker speed was treated as a continuous factor, the optimal speed was low ( 135 rpm) with vials with no hCG, but high ( 200 rpm) with the other cases. It is felt that the overall optimal speed is around 175 rpm based on our studies and those of others. We found that 200 rpm is difficult to maintain in the incubator, especially over the 24 hour period without movement of the shaker itself and results in dissociation of the testicular fragments.

The optimal volume of the media for test tubes was at the lower extreme of 2.5 ml but in all other cases it was approximately 4 ml. Therefore we kept the incubation volume at 5.0 ml for ease of the other technical operations that had to be performed in later assays. This included larger aliquots for LDH determinations than had originally been planned.

15.2 Organ Preparation Factors Experiments In the organ preparation series of experiments, the use of warm and cold Delbecco's Phosphate Buffered Saline ( DPBS) as well as cold media was evaluated as well as the time the tissue spent in these solutions , the aliquot volume and the hCG concentration. In the cases with 89 hCG, there were very small degrees of freedom for error, resulting in difficulty in testing for the significance of factors. In the cases with no hCG, there were somewhat smaller RMSEs for cold media than for cold or warm buffered saline. For the cold solutions, time delay ( the time from placing the tissue in the holding solution until placing it in the media to start the incubations) was the dominant factor as would be expected. Baseline was important for the buffered saline cases.

Cold buffered saline cases yielded slightly higher testosterone values than cold media and the cold media values were slightly higher than the warm buffered saline. The time delays were inconsistent when considered across time points. Aliquot volumes were also inconsistent and often at the extremes of the regions. The LDH experiments performed with the optimized factors appeared to confirm that the time delay should not be more than one hour before the starting assay incubation. These data combined with the results from the previous experiments to determine the hCG concentration to be used in the optimized assay. The cold DPBS appeared to be the best solution to collect the testes in prior to the initial assay incubation. 90 16.0 CONCLUSIONS Based upon the incubation experiments, the optimized assay factors that yielded the maximum testosterone concentrations were the use of scintillation vials with testicular fragments of 100 to 175 mg. This fragment size should allow for at least 8 10 fragments per testis for use in the pre validation of the sliced testis assay. The volume of incubation media should be 4 5 ml.

It was difficult to determine the optimal factors from the testis preparation experiments. There should have been more determinations using hCG. The small number used made the degrees of freedom for error very small. The cases without hCG however showed that cold buffered saline with no more than one hour of delay before the first assay incubation in media 199 was optimal. The aliquot volume can be less than 0.5 ml ( the optimal appeared to be around 0.3ml) but the larger volume is necessary if more than one determination is to be made from the aliquot. When smaller aliquots were used, there was not enough sample if repeat determinations for testosterone were necessary.

Therefore, the optimal assay was run using Delbecco's PBS for collection of testes for a period less than one hour. The testis fragment was then placed in a scintillation vial with 5 ml of media 199 and incubated at 36 ° C for one hour. The media was then replaced with fresh media and the baseline samples were taken. Then media removed was replaced with the same volume of media or media plus hCG. The sample was then re incubated and hourly samples were taken. The optimal assay was run as part of the 24 hour sampling assay also and the sampling after 4 hours was not optimal in terms of the rise in both testosterone and LDH concentration. This probably is an indication of cell death and release of testosterone.

The injury experiment showed the differences in LDH and testosterone concentration with the different types of injury. Chemical injury with Triton X 100 caused the cell to lyse resulting in high LDH values and the cellular testosterone was released at the one hour time point. Heat ( 42 ° C) caused the LDH to continually rise but the testosterone remained low indicating that the cellular testosterone production was minimal ( probably due to denaturation of enzymatic proteins) during incubation. The trauma of mincing the tissue resulted in both the testosterone and LDH concentrations maximal at the 1 hour time point. Only the heated sample showed no additional testosterone release after hCG stimulation.

The vehicle experiment should help us to determine the influence of vehicle concentration influence on the assay system. The testosterone assays for these experiments need to also include vehicle blanks to determine if the vehicle itself is affecting the assay.

It should be noted that all of these optimization experiments were performed on control testicular fragments ( albeit + hCG) . There is no guarantee that the same optimized conditions established in this work would necessarily hold for testicular tissue incubated with LH, FSH or an anti androgen with the mechanism of action of inhibition of testosterone biosynthesis. 91 APPENDIX 1 LDH Validation and Verification with Media 199 without Phenol Red ( See Draft Letter Report for Phase I)


[Federal Register Volume 85, Number 143 (Friday, July 24, 2020)]
[Notices]
[Page 44881]
[FR Doc No: 2020-16077]

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[FR Doc. 2020-16077 Filed 7-23-20; 8:45 am]
BILLING CODE 6717-01-P


APPENDIX D STUDY PROTOCOLS FOR ETHYLENE DICHLORIDE This Appendix contains detailed study protocols for the toxicity studies to be conducted for ethylene dichloride, and is organized into the following sections:

D. 1 Combined Acute Toxicity with BAL and Histopathology and Acute Neurotoxicity ( Inhalation)

D. 2 Subchronic Neurotoxicity ( Oral)

D. 3 Reproductive Toxicity ( Oral)

G:\ Proj ect\ HAPs EDC\ master\ reports\ edc AppD. wpd10/ 01/ 01 1 RECEIVED OPPT NCIC 2003 MAR11 5: 03PM OPPT 2003 0010 0010 D. 1 Combined Acute Inhalation Toxicity with BAL and Histopathology and Acute Neurotoxicity ( Inhalation)

Proposed Test Parameters All proposed test parameters ( except test concentrations) are per TSCA guidelines for acute inhalation toxicity requirements ( 40 CFR 799.9135, provided in Appendix B), and are to be conducted in compliance with good laboratory practice standards ( 40 CFR 792). For testing and reporting schedule, see Appendix A.

Parameter Proposed Test species Rat Strain F344 Age Young adult Sex Male and Female Health Status Evaluate initially Number ofanimals 5/ sex/ dose for acute toxicity ( with BAL and histopathology) plus 10/ sex/ dose for acute neurotoxicity testing Control Groups Concurrent sham control Positive Controls ( behavioral and neuropathology) Acceptable historical control data from testing laboratory Concentration level and selection Control + 3 exposure concentrations Limit dose To be determined from range finding study andlor existing studies 8 hr study If triggered ( 3 dose groups) Exposure Whole body Environmental conditions c22 ° C; 40  60% humidity, 12 15 air changes/ hr Exposure periodicity 4 hr ( 8 hr if triggered) Physical measurements Environmental conditions monitored Observation period 24 hr for acute toxicity; 14 days for acute neurotoxicity Gross pathology Full necropsy, organ weights Histopathology Respiratory tract, liver, and kidney of controls and high dose group Bronchoalveolar lavage Provide indicators oflung damage Equipment and test methods reporting Adequately defined Results reporting Tabular results, per animal, statistics Time ofneurotoxicity testing 0, 4 hr, 7d, 14d Functional observational battery Standard evaluations for appearance, behavior, and functional integrity List of neurotoxicity measures Autonomic function, abnormal motor movements, response to general and sensory stimuli, alertness, grip strength, landing foot splay, body weight,

G:\ Project\ HAPs EDC\ master\ reports\ edc AppD. wpd 10/ 01/ 01 2 behavioral changes Motor activity Individually assessed, automated Neuropathology Neuropathological examinations ( CNS and peripheral) Results Tabular, per animal, statistics Evaluation Adequately described Study Design and Conduct: Acute Toxicity with BAL and Histopathology The test species will consist of young adult male and female ( nulliparous and nonpregnant) F344 rats. At least five males and five females shall be used in each concentrationlduration and control group. Animals shall be randomly assigned to treatment and control groups. The control group shall be a sham treated group. Except for treatment with the test substance, animals in the control group shall be handled in a manner identical to the test group animals.

Test animals will be exposed to the substance using a whole body exposure chamber. The laboratory shall measure the following: chemical purity, rate of airflow, actual concentrations of the test substance in the breathing zone, temperature and humidity. Food and water shall be withheld during exposure.

The bronchoalveolar lavage and respiratory pathology shall be conducted 24 hrs following exposure to allow expression of signs of toxicity. Animals will be subjected to a full gross necropsy. Lungs, liver, kidneys, adrenals, brain, and gonads shall be weighed wet, as soon as possible after dissection. The following organs and tissues, or representative samples thereof, shall be preserved in a suitable medium for possible future histopathological examination: All gross lesions; brain including sections of medullalpons; cerebellar cortex and cerebral cortex; pituitary; thyroidlparathyroid; thymus; heart; sternum with bone marrow; salivary glands; liver; spleen; kidneys; adrenals; pancreas; gonads; accessory genital organs; aorta; skin; gall bladder; esophagus; stomach; duodenum; jejunum; ileum; cecum; colon; rectum; urinary bladder; representative lymph nodes; thigh musculature; peripheral nerve; spinal cord at three levels cervical, midthoracic, and lumbar; and eyes. Respiratory tract tissues shall also be preserved in a suitable medium.

Full histopathology shall be performed on the respiratory tract, liver and kidney of all animals in the control and high concentration groups, on all gross lesions which differ from controls in frequency, distribution, type, or severity in all concentration groups and on target organs in all animals, as indicated by the observations in the high concentration group in this study. Archived organs identified as targets of toxicity from results of the 90 day study. The lungs will be lavaged using physiological saline, consisting oftwo washes of approximately 80% of the total lung volume. The following parameters shall be determined in the lavage fluid as indicators of cellular damage in the lungs: total protein, cell count, and percent leukocytes. In addition, a phagocytosis assay shall be performed to determine macrophage activity.

If no adverse effects are seen in the 4 hr study as compared with controls, no further testing is necessary. If the 4 hr study shows positive effects in histopathology or the bronchoalveolar lavage, an 8 hr study shall be conducted. This will be determined by the study director following G:\ Project\ HAPs EDC\ master\ reports\ edc AppD. wpd 10/ 01/ 01 3 consultation with the HAP Task Force and USEPA. Only those tissues showing positive results in the 4 hr study must be pursued in the follow up 8 hr study.

The final test report shall include the following information: a description of equipment and test methods, a description of exposure apparatus, and a description of the measuring/ monitoring equipment. Exposure data shall be tabulated and presented with mean values and measure of variability ( e. g., standard deviation) and should include: chemical purity, airflow rates, temperature and humidity, nominal concentration, actual concentration.

The following information shall be tabulated by test group exposure level to indicate: number of animals exposed, number of animals dying, number of animals showing overt signs of toxicity, pre and post exposure body weight change in animals, counts and incidence of gross and histopathological alterations, amount of administered lavage fluid and recovered lavage fluid for each test animal, magnitude ofchange ofbiochemical and cytologic indices in lavage fluids.

Study Design and Conduct: Acute Neurotoxicity An additional 10 animals/ sex/ dose group shall be exposed as described above for the Acute Toxicity study. At least five males and five females should be used in each dose and control group for terminal neuropathology.

All animals shall be weighed on each test day and at least weekly during the observation period. At a minimum, observations and activity testing shall be made before the initiation ofexposure, at the estimated time ofpeak effect at the end ofthe exposure, and at 7 and 14 days after dosing.

The functional observational battery shall include the following: ranking of the degree of lacrimation and salivation, with a range of severity scores from none to severe, presence or absence of piloerection and exophthalmus, ranking or count of urination and defecation, including polyuria and diarrhea, pupillary function such as constriction of the pupil in response to light or a measure of pupil size, degree ofpalpebral closure, description of any convulsions, tremors, or abnormal motor movements, ranking of the subject's reactivity to general stimuli such as removal from the cage or handling, ranking of the subject's general level of activity during observations of the unperturbed subject in the open field, descriptions ofposture and gait abnormalities, forelimb and hindlimb gripstrength, a quantitative measure of landing foot splay, sensorimotor responses to stimuli of different modalities, body weight, description of any unusual or abnormal behaviors and apearances. Further information on the neurobehavioral integrity ofthe subject may be provided by: count of rearing activity on the open field, ranking of righting ability, body temperature, excessive or spontaneous vocalizations, alterations in rate and ease of respiration, sensorimotor responses to visual or proprioceptive stimuli. Motor activity shall be monitored by an automated activity recording apparatus. Each animal shall be tested individually. Positive historical control data for functional tests will be provided by the testing laboratory.

Any gross abnormalities should be noted. Tissue samples taken should adequately represent all major regions of the nervous system. Representative histological sections from the tissue samples should be examined microscopically by an appropriately trained pathologist for evidence of neuropathological alterations. If no neuropathological alterations are observed in G:\ Project\ HAPs EDC\ master\ reports\ edc AppD. wpd 10/ 01/ 01 4 samples from the high dose group, subsequent analysis is not required. If any evidence of neuropathological alterations is found in the qualitative examination, then a subjective diagnosis shall be performed for the purpose ofevaluating dose response relationships. All regions ofthe nervous system exhibiting any evidence of neuropathological changes should be included in this analysis. For each type ofdose related lesion observed, examples ofdifferent degrees of severity should be described. Photomicrographs of typical examples of treatment related regions are recommended to augment these descriptions. Positive historical control data for neuropathological testing methodology will be provided by the testing laboratory.

The final test report shall include the following information: description of equipment and test methods, a short justification explaining any decisions involving professional judgment, a detailed description of the procedures used to standardize observations, positive control data ( historical data preferred). The following information shall be arranged by test group dose level: identification number, body weight, score on each sign at each observation time, the time and cause of death ( if appropriate), total session activity counts, and intrasession subtotals for each day measured, the number of animals at the start ofthe test, the number ofanimals showing each observation score at each observation time, mean and standard deviation for each continuous endpoint at each observation, results of statistical analyses for each measure ( where appropriate). Neuropathological observations may be presented in the following recommended format: description of lesions for each animal, a list of structures examined as well as the locations, nature, frequency, and severity oflesions.

G:\ Project\ HAPs EDC\ master\ reports\ edc AppDwpd 10/ 01/ 01 5 D. 2 Subchronic Neurotoxicity ( Oral Route)

Proposed Test Parameters All proposed test parameters ( except dose selections) are per TSCA requirements ( 40 CFR 799.9620, provided in Appendix B), and in compliance with good laboratory practice standards ( 40 CFR 792). For testing and reporting schedule, see Appendix A.

Parameter Proposed Test species Rat Strain F344 Age Young adult (> 42 d) Sex Male and Female Number ofanimals 10/ sex/ dose Control Groups Concurrent vehicle control Positive controls for behavioral and neuropathology Acceptable historical control data from testing laboratory Concentration level and selection Control + 3 doses in drinking water Dose selection Concentration to be determined based on acute inhalation findings and PBPK modeling Administration ofthe substance In drinking water for subchronic testing Time of testing Subchronic ( 0, 4 wk, 8 wk, 13 wk) Functional observational battery Standard evaluations for appearance, behavior, and functional integrity List of measures Autonomic function, abnormal motor movements, response to general and sensory stimuli, alertness, grip strength, landing foot splay, body weight, behavioral changes Motor activity Individually assessed, automated Neuropathology Neuropathological examinations Results Tabular, per animal, statistics Evaluation Adequately described Dose Selection The preliminary PBPK model and results ofthe acute studies will be used to select doses for the oral studies based on expected parent blood concentrations and amount metabolized below, slightly above, and well above saturation of the P 450 enzymes. The dose levels for the subchronic study may be modified pending the results of the acute study. Study Design and Conduct For the subchronic neurotoxicity studies, the test species will consist of young adult male and female ( nulliparous and nonpregnant) F344 rats. At least 10 males and 10 females shall be used in each concentrationlduration and control group. At least five males and five females should be used in each dose and control group for terminal neuropathology.

All animals shall be weighed on each test day and at least weekly during the exposure period. For the subchronic study, observations and activity measurements shall be made before the G:\ Project\ HAPs EDC\ master\ reports\ edc AppD. wpd 10/ 01/ 01 6 initiation of exposure and before the daily exposure, and during the 4th, 8th, and 13 th weeks of exposure.

The functional observational battery shall include the same observations as noted for the acute neurotoxicity studies. Notation of any gross abnormalities, tissue sampling, and histopathology shall also be as described for acute neurotoxicity testing and final report requirements will also be the same as for acute neurotoxicity testing.

G:\ Project\ HAPs EDC\ master\ reports\ edc AppD. wpd 10/ 01/ 01 7 D. 3 Reproductive Toxicity ( Oral Route)

Proposed Test Parameters All proposed test parameters ( except dose selections) are per TSCA requirements for reproductive toxicity testing ( 40 CFR 799.9380, provided in Appendix B), and in compliance with good laboratory practice standards ( 40 CFR 792). For testing and reporting schedule, see Appendix A.

Parameter Proposed Species Rat Strain F344 Age Young adult Number of animals 20 pregnant females/ dose Doses Control + 3 concentrations in drinking water. Highest dose to be determined from acute inhalation study and PBPKmodeling Route Drinking water Exposure Frequency Daily Design Multigenerational; exposure > 10 wk prior to mating Mating Random Control Vehicle control Observations ( adult) Daily/ weekly Observations ( litter) PND 0, 4, 7, 14, 21 Endpoints Fertility index, gestation index, sperm morphology, age at vaginal opening or preputial separation, gross necropsy, organ weight, histopathology Data reporting Tabular Evaluation Statistics described Study Design and Conduct Reproductive toxicity testing shall be conducted using young, healthy F344 rats. Parental animals shall be 5 to 9 weeks old at the start of dosing. The females shall be nulliparous and nonpregnant. Each group shall colltain a sufficient number of mating pairs to yield approximately 20 pregnant females. The animals should be dosed with the test substance on a 7 days a week basis. For both sexes ( P and F1), dosing shall be continued for at least 10 weeks before the mating period, and shall continue until termination. For each mating, each female shall be placed with a single randomly selected male from the same dose level ( 1: 1 mating) until evidence of copulation is observed or either 3 estrous periods or 2 weeks has elapsed. For mating the Fl offspring, at least one male and one female should be randomly selected from each litter for mating with another pup of the same dose level but different litter, to produce the F2 generation. Throughout the test period, each parental animal shall be observed at least once daily, considering the peak period of anticipated effects after dosing. Mortality, moribundity, pertinent behavioral changes, signs of difficult or prolonged parturition, and all signs of overt toxicity shall be recorded at this cageside examination. In addition, thorough physical examinations should be conducted weekly on each animal. Parental animals ( P and Fl) shall be weighed on the first day of dosing and weekly thereafter. Parental females ( P and F1) should be weighed at a minimum on approximately gestation days 0, 7, 14, and 21, and during lactation on the same days as the weighing of litters. During the premating and gestation periods, food and G:\ Project\ HAPs EDC\ master\ reports\ edc AppD. wpd 10/ 01/ 01 8 water consumption shall be measured weekly at a minimum. Estrous cycle length and normality should be evaluated by vaginal smears for all P and Fl females during a minimum of 3 weeks prior to mating and throughout cohabitation; care should be taken to prevent the induction of pseudopregnancy.

For all P and Fl males at termination, sperm from one testis and one epididymis shall be collected for enumeration of homogenization resistant spermatids and cauda epididymal sperm reserves, respectively. In addition, sperm from the cauda epididymis ( or vas deferens) should be collected for evaluation of sperm motility and sperm morphology. The total number of homogenization resistant testicular sperm and cauda epididymal sperm should be enumerated. Cauda sperm reserves can be derived from the concentration and volume of sperm in the suspension used to complete the qualitative evaluations, and the number of sperm recovered by subsequent mincing and/ or homogenizing of the remaining cauda tissue. Enumeration in only control and high dose P and Fl males may be performed unless treatment related effects are observed; in that case, the lower dose groups should also be evaluated. An evaluation of epididymal ( or vas deferens) sperm motility should be performed. Sperm should be recovered while minimizing damage, and the percentage of progressively motile sperm should be determined. For objective evaluations, an acceptable counting chamber of sufficient depth can be used to effectively combine the assessment ofmotility with sperm count and sperm morphology. When computer assisted motion analysis is performed, the derivation of progressive motility relies on user defined thresholds for average path velocity and straightness or linear index. If samples are videotaped, or images otherwise recorded, at the time of necropsy, subsequent analysis of only control and high dose P and Fl males may be performed unless treatmentrelated effects are observed; in that case, the lower dose groups should also be evaluated. In the absence of a video or digital image, all samples in all treatment groups should be analyzed at necropsy. A morphological evaluation of an epididymal ( or vas deferens) sperm sample shall be performed. Sperm ( at least 200 per sample) should be examined as fixed, wet preparations and classified as either normal ( both head and midpiece/ tail appear normal) or abnormal. Examples of morphologic sperm abnormalities would include fusion, isolated heads, and misshapen heads andlor tails. Evaluation of only control and high dose P and Fl males may be performed unless treatment related effects are observed; in that case, the lower dose groups should also be evaluated.

Each litter should be examined as soon as possible after delivery ( lactation day 0) to establish the number and sex ofpups, stillbirths, live births, and the presence of gross anomalies. Pups found dead on day 0 should be examined for possible defects and cause of death. Live pups should be counted, sexed, and weighed individually at birth, or soon thereafter, at least on days 4, 7, 14, and 21 of lactation, at the time of vaginal patency or balanopreputial separation, and at termination. The age of vaginal opening and preputial separation should be determined for Fl weanlings selected for mating. If there is a treatment related effect in Fl sex ratio or sexual maturation, anogenital distance should be measured on day 0 for all F2 pups. All P and Fl adult males and females should be terminated when they are no longer needed for assessment of reproductive effects. Fl offspring not selected for mating and all F2 offspring should be terminated at comparable ages after weaning. At the time of termination or death during the study, all parental animals ( P and Fl) and when litter size permits at least three pups per sex per litter from the unselected Fl weanlings and the F2 weanlings shall be examined macroscopically for any structural abnormalities or pathological changes. Special attention shall be paid to the G:\ Project\ HAPs EDC\ master\ reports\ edc AppD. wpd 10/ 01/ 01 9 organs of the reproductive system. Dead pups or pups that are terminated in a moribund condition should be examined for possible defects and/ or cause of death. ( iii) At the time of necropsy, a vaginal smear should be examined to determine the stage of the estrous cycle. The uteri of all cohabited females should be examined, in a manner which does not compromise histopathological evaluation, for the presence and number of implantation sites. At the time of termination, the following organs of all P and Fl parental animals shall be weighed: uterus ( with oviducts and cervix), ovaries, testes, epididymides ( total weights for both and cauda weight for either one or both), seminal vesicles ( with coagulating glands and their fluids), prostate, brain, pituitary, liver, kidneys, adrenal glands, spleen, and known target organs. For Fl and F2 weanlings that are examined macroscopically, the following organs shall be weighed for one randomly selected pup per sex per litter: brain, spleen and thymus. The following organs and tissues, or representative samples thereof, shall be fixed and stored in a suitable medium for histopathological examination. For the parental ( P and Fl) animals: vagina, uterus with oviducts, cervix, and ovaries, one testis ( preserved in Bouins fixative or comparable preservative), one epididymis, seminal vesicles, prostate, coagulating gland, pituitary, adrenal glands, any target organs identified upon gross necropsy. For Fl and P2 weanlings selected for macroscopic examination: grossly abnormal tissue and target organs ( if known). Full histopathology of the organs listed above shall be performed for ten randomly chosen high dose and control P and Fl animals per sex, for those animals that were selected for mating. Organs demonstrating treatment related changes shall also be examined for the remainder of the highdose and control animals and for all parental animals in the low and mid dose groups. Additionally, reproductive organs of the low and mid dose animals suspected of reduced fertility. Besides gross lesions such as atrophy or tumors, testicular histopathological examination should be conducted in order to identify treatment related effects such as retained spermatids, missing germ cell layers or types, multinucleated giant cells, or sloughing of spermatogenic cells into the lumen. Examination of the intact epididymis should include the caput, corpus, and cauda, which can be accomplished by evaluation ofa longitudinal section, and should be conducted in order to identify such lesions as sperm granulomas, leukocytic infiltration ( inflammation), aberrant cell types within the lumen, or the absence of clear cells in the cauda epididymal epithelium. The postlactational ovary should contain primordial and growing follicles as well as the large corpora lutea of lactation. A quantitative evaluation ofprimordial follicles should be conducted for all Fl females if any of the following treatment related findings were observed: reductions in ovarian weight and abnormal ovarian histopathology findings, abnormal estrous cyclicity and female infertility, depletion of testicular spermatid counts in Fl males and evidence of germ cell depletion in testicular histopathology evaluations.

Data shall be reported individually and summarized in tabular form, showing for each test group the types ofchange and the number ofanimals displaying each type ofchange. An evaluation of test results, including the statistical analysis, shall be provided. This should include an evaluation of the relationship, or lack thereof, between the exposure of the animals to the test substance and the incidence and severity ofall abnormalities. When appropriate, historical control data should be used to enhance interpretation ofstudy results. Historical data, when used, should be compiled, presented, and analyzed in an appropriate and relevant manner. In order to justify its use as an analytical tool, information such as the dates ofstudy conduct, the strain and source of the animals, and the vehicle and route ofadministration should be included. Statistical analysis of the study findings should include sufficient information on the method ofanalysis, so that an independent reviewer/ statistician can reevaluate and reconstruct the analysis.

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