[Federal Register Volume 75, Number 1 (Monday, January 4, 2010)]
[Notices]
[Pages 170-175]
[FR Doc No: E9-31162]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-61236; File No. SR-NYSEArca-2009-113]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
of Proposed Rule Change for the Listing and Trading of Sprott Physical
Gold Trust

December 23, 2009.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on December 15, 2009, NYSE Arca, Inc. (``NYSE Arca'' or the
``Exchange'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C.78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    NYSE Arca, Inc. (``Exchange''), through its wholly-owned subsidiary
NYSE Arca Equities, Inc. (``NYSE Arca Equities''), proposes to list and
trade units \4\ of the Sprott Physical Gold Trust (the ``Trust'')
pursuant to NYSE Arca Equities Rule 8.201. The text of the proposed
rule change is available on the Exchange's Web site at http://www.nyse.com, at the Exchange's principal office and at the
Commission's Public Reference Room.
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    \4\ Each unit represents an equal, fractional, undivided
ownership interest in the net assets of the Trust attributable to
the particular class of units.
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II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

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

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

1. Purpose
    The Exchange proposes to list and trade units (``Units'') of the
Trust under NYSE Arca Equities Rule 8.201. Under NYSE Arca Equities
Rule 8.201, the Exchange may propose to list and/or trade pursuant to
unlisted trading privileges (``UTP'') ``Commodity-Based Trust Shares.''
\5\ The Commission has previously approved listing on the Exchange
under NYSE Arca Equities Rule 5.2(j)(6) and 8.201, respectively, shares
of the streetTRACKS Gold Trust and iShares COMEX Gold Trust.\6\ Prior
to their listing on the Exchange, the Commission approved listing of
the streetTRACKS Gold Trust on the New York Stock Exchange (``NYSE'')
and listing of iShares COMEX Gold Trust on the American Stock Exchange
LLC.\7\ In addition, the Commission has approved trading of the
streetTRACKS Gold Trust and iShares Silver Trust and [sic] on the
Exchange pursuant to UTP.\8\ The Commission also has approved listing
of the iShares Silver Trust on the Exchange \9\ and, previously,
listing of the iShares Silver Trust on the American Stock Exchange LLC
(now known as ``NYSE Amex LLC'').\10\ Further, the Commission has also
approved listing on the Exchange under NYSE Arca Equities Rule 8.201
shares of ETFS Silver Trust \11\ and ETFS Gold Trust.\12\
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    \5\ Commodity-Based Trust Shares are securities issued by a
trust that represent investors' discrete identifiable and undivided
beneficial ownership interest in the commodities deposited into the
Trust.
    \6\ See Securities Exchange Act Release No. 56224 (August 8,
2007), 72 FR 45850 (August 15, 2007) (SR-NYSEArca-2007-76)
(approving listing on the Exchange of the streetTRACKS Gold Trust);
Securities Exchange Act Release No. 56041 (July 11, 2007), 72 FR
39114 (July 17, 2007) (SR-NYSEArca-2007-43) (order approving listing
on the Exchange of iShares COMEX Gold Trust).
    \7\ See Securities Exchange Act Release No. 50603 (October 28,
2004), 69 FR 64614 (November 5, 2004) (SR-NYSE-2004-22) (order
approving listing of streetTRACKS Gold Trust on NYSE); Securities
Exchange Act Release No. 51058 (January 19, 2005), 70 FR 3749
(January 26, 2005) (SR-Amex-2004-38) (order approving listing of
iShares COMEX Gold Trust on the American Stock Exchange LLC).
    \8\ See Securities Exchange Act Release No. 53520 (March 20,
2006), 71 FR 14977 (March 24, 2006) (SR-PCX-2005-117) (approving
trading on the Exchange pursuant to UTP of the iShares Silver
Trust); Securities Exchange Act Release No. 51245 (February 23,
2005), 70 FR 10731 (March 4, 2005) (SR-PCX-2004-117) (approving
trading on the Exchange of the streetTRACKS Gold Trust pursuant to
UTP).
    \9\ See Securities Exchange Act Release No. 58956 (November 14,
2008), 73 FR 71074 (November 24, 2008) (SR-NYSEArca-2008-124)
(approving listing on the Exchange of the iShares Silver Trust).
    \10\ See Securities Exchange Act Release No. 53521 (March 20,
2006), 71 FR 14967 (March 24, 2006) (SR-Amex-2005-72) (approving
listing on the American Stock Exchange LLC of the iShares Silver
Trust).
    \11\ See Securities Exchange Act Release No. 59781 (April 17,
2009), 74 FR 18771 (April 24, 2009) (SR-NYSEArca-2009-28) (approving
listing on the Exchange of the ETFS Silver Trust).
    \12\ See Securities Exchange Act Release No. 59895 (May 8,
2009), 74 FR 22993 (May 15, 2009) (SR-NYSEArca-2009-40) (approving
listing on the Exchange of the ETFS Gold Trust).
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    Sprott Asset Management LP is the sponsor or manager of the Trust
(the ``Sponsor'' or the ``Manager'',\13\ as the case may be), RBC Dexia
Investor Services Trust is the trustee of the Trust

(the ``Trustee''),\14\ the Royal Canadian Mint is the custodian for the
physical gold bullion owned by the Trust (the ``Gold Custodian''),\15\
and RBC Dexia serves as the custodian of the Trust's assets other than
physical gold bullion (the ``Non-Gold Custodian'').\16\
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    \13\ The Manager is a limited partnership existing under the
laws of Ontario, Canada, and acts as manager of the Trust pursuant
to the Trust's trust agreement and the management agreement. The
Manager provides management and advisory services to the Trust.
Additional details regarding the Manager are set forth in the
Registration Statement on Form F-1 for the Sprott Physical Gold
Trust, filed with the Commission on December 9, 2009 (No. 333-
163601) (the ``Registration Statement'').
    \14\ The Trustee holds title to the Trust's assets on behalf of
the Unitholders and has, together with the Manager, exclusive
authority over the assets and affairs of the Trust. The Trustee has
a fiduciary responsibility to act in the best interest of the
Unitholders. Additional details regarding the Trustee are set forth
in the Registration Statement.
    \15\ The Gold Custodian will be responsible for and will bear
all risk of the loss of, and damage to, the Trust's physical gold
bullion that is in its custody, subject to certain limitations based
on events beyond the Gold Custodian's control. The Manager, with the
consent of the Trustee, may determine to change the custodial
arrangements of the Trust. Additional details regarding the Gold
Custodian are set forth in the Registration Statement.
    \16\ The Non-Gold Custodian will be responsible for and will
bear all risk of the loss of, and damage to, the Trust's assets
(other than physical gold bullion) that are in its custody, subject
to certain limitations based on events beyond the Non-Gold
Custodian's control. The Manager, with the consent of the Trustee,
may determine to change the custodial arrangements of the Trust.
Additional details regarding the Non-Gold Custodian are set forth in
the Registration Statement.
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Listing Rules
    Definition. Rule 8.201(c)(1) defines Commodity-Based Trust Shares
as a security (a) that is issued by a trust that holds a specified
commodity deposited with the trust; (b) that is issued by such trust in
a specified aggregate minimum number in return for a deposit of a
quantity of the underlying commodity; and (c) that, when aggregated in
the same specified minimum number, may be redeemed at a holder's
request by such trust which will deliver to the redeeming holder the
quantity of the underlying commodity.
    The Trust will issue Units, each of which represents an equal,
fractional undivided ownership interest in the net assets of the Trust
attributable to the particular class of Units. Except with respect to
cash held by the Trust to pay expenses and anticipated redemptions, the
Trust expects to own only London Good Delivery physical gold bullion.
The investment objective of the Trust is for the Units to reflect the
performance of the price of gold bullion, less the expenses of the
Trust's operations.\17\ The Trust is not actively managed and does not
engage in any activities designed to obtain a profit from, or to
ameliorate losses caused by, changes in the price of gold bullion. The
Trust is neither an investment company registered under the Investment
Company Act of 1940 nor a commodity pool for purposes of the Commodity
Exchange Act.\18\ The Units will be issued in an initial public
offering. The Trust may issue additional Units (i) in future offerings
if the gross proceeds received by the Trust per Unit is not less than
100% of the most recently calculated NAV or (ii) by way of a
distribution in Units in connection with an income distribution. The
Trust will not issue Units on an on-going or daily basis. At the start
of trading the Trust will issue a minimum of 1,000,000 Units to at
least 400 holders (``Unitholders''), as further described below.
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    \17\ The descriptions of the Trust, the Units and the gold
market contained herein are based on the Registration Statement.
    \18\ The Trust does not trade in gold futures contracts. The
Trust takes delivery of physical gold that complies with certain
gold delivery rules. Because the Trust does not trade in gold
futures contracts on any futures exchange, the Trust is not
regulated as a commodity pool, and is not operated by a commodity
pool operator.
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    The Units will be redeemable monthly at the option of the holder.
The redemption process is further described below.
    The Exchange represents that the Units satisfy the remaining
requirements of NYSE Arca Equities Rule 8.201 and thereby qualify for
listing on the Exchange.\19\
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    \19\ With respect to application of Rule 10A-3 (17 CFR 240.10A-
3) under the Securities Exchange [sic] of 1934 (``Act'') (15 U.S.C.
78a), the Trust relies on the exemption contained in Rule 10A-
3(c)(7).
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Operation of the Gold Market
    A detailed description of the gold market is set forth in the
Registration Statement.
Secondary Market Trading and Liquidity
    While the Trust's investment objective is for the Units to reflect
the performance of physical gold bullion, less the expenses of the
Trust, the Units may trade in the secondary market on the NYSE Arca at
prices that are lower or higher relative to their net asset value per
Unit (``NAV''). The NAV is expected to fluctuate with changes in the
market value of the Trust's assets. The trading price of the Units will
fluctuate in accordance with changes in the NAV as well as market
supply and demand. The amount of the discount or premium in the trading
price relative to the NAV may be influenced by non-concurrent trading
hours between the NYSE Arca and the COMEX and other major world gold
markets. While the Units will trade on the NYSE Arca until 4 p.m., New
York time, liquidity in the global gold market will be reduced after
the close of the major world gold markets, including London and of the
COMEX division of the New York Mercantile Exchange at 1:30 p.m., New
York time. As a result, during this time, trading spreads, and the
resulting premium or discount to the NAV may widen.
Trust Expenses
    The fees and expenses of the Trust are set forth in detail in the
Registration Statement.
Initial Public Offering and Redemption of Units
    The Trust will offer at a minimum, 1,000,000 Units in its initial
public offering to a minimum of 400 Unitholders. Each Unit will
represent an equal, fractional, undivided ownership interest in the net
assets of the Trust attributable to the particular class of Units. It
is not currently intended that the Trust will create additional Units.
    Unitholders may redeem their Units on a monthly basis.
Redemption for Physical Gold
    Subject to the terms of the trust agreement and the Manager's right
to suspend redemptions under certain circumstances described in the
registration statement, Units may be redeemed at the option of a
Unitholder for physical gold bullion in any calendar month. Units
redeemed for physical gold will be entitled to a redemption price equal
to 100% of the NAV of the redeemed Units on the last Business Day, as
defined herein, of the calendar month in which the redemption request
is processed, less redemption and delivery expenses. Redemption
requests for gold must be for amounts that are at least equivalent in
value to one London Good Delivery bar or an integral multiple thereof,
plus applicable expenses. A ``London Good Delivery bar'' contains
between 350 and 430 troy ounces of gold. Any fractional amount of
redemption proceeds in excess of one London Good Delivery bar or an
integral multiple thereof will be paid in cash at a rate equal to 100%
of the NAV of such excess amount. The ability of a Unitholder to redeem
Units for physical gold bullion may be limited by the sizes of London
Good Delivery bars held by the Trust at the time of the redemption. A
Unitholder redeeming Units for gold will be responsible for expenses
incurred by the Trust in connection with such redemption and applicable
delivery expenses, including the handling of the notice of redemption,
the delivery of the physical bullion for units that are being redeemed
and the applicable gold storage in-and-out fees.
    A redemption notice to redeem Units for physical gold bullion must
be received by the Trust's transfer agent no later than 4 p.m. Toronto
time, on the

15th day of the calendar month in which the redemption notice will be
processed or, if such day is not a day on which banks located in New
York, New York, are open for the transaction of banking business (a
``Business Day''), then on the immediately following day that is a
Business Day. Any redemption notice received after such time will be
processed in the next month.
    Physical gold bullion received by a Unitholder as a result of a
redemption of Units will be delivered by armored transportation service
carrier pursuant to delivery instructions provided by the Unitholder.
The armored transportation service carrier will be engaged by or on
behalf of the redeeming Unitholder. Such physical gold bullion can be
delivered (i) To an account established by the Unitholder at an
institution located in North America authorized to accept and hold
London Good Delivery bars; (ii) in the United States, to any physical
address (subject to approval by the armored transportation service
carrier); (iii) in Canada, to any business address (subject to approval
by the armored transportation service carrier); and (iv) outside of the
United States and Canada, to any address approved by the armored
transportation service carrier. Physical gold bullion delivered to an
institution located in North America authorized to accept and hold
London Good Delivery bars will likely retain its London Good Delivery
status while in the custody of such institution; physical gold bullion
delivered pursuant to a Unitholder's delivery instruction to a
destination other than an institution located in North America
authorized to accept and hold London Good Delivery bars will no longer
be deemed London Good Delivery once received by the Unitholder. The
armored transportation service carrier will receive gold bullion in
connection with a redemption of Units approximately 10 Business Days
after the end of the month in which the redemption notice is processed.
Any cash to be received by a redeeming Unitholder in connection with a
redemption of Units for physical gold bullion will be delivered to the
Unitholder's brokerage account within 10 Business Days after the
calendar month in which the redemption is processed.
Redemption for Cash
    Subject to the terms of the trust agreement and the Manager's right
to suspend redemptions under certain circumstances described in the
registration statement, Units may be redeemed at the option of a
Unitholder for cash on a monthly basis. Units redeemed for cash will be
entitled to a redemption price equal to 95% of the lesser of (i) the
volume-weighted average trading price of the Units traded on the NYSE
Arca or, if trading has been suspended on NYSE Arca, the trading price
of the units traded on the Toronto Stock Exchange, for the last five
Business Days of the month in which the redemption request is processed
and (ii) the NAV of the redeemed Units as of 4 p.m., Toronto time, on
the last Business Day of such month. Cash redemption proceeds will be
transferred to a redeeming Unitholder approximately three Business Days
after the end of the month in which the redemption notice is processed.
See ``Redemption of Units'' for detailed terms and conditions relating
to the redemption of Units for cash.
    A redemption notice to redeem Units for cash must be received by
the Trust's transfer agent no later than 4 p.m.. Toronto time, on the
15th day of the calendar month in which the redemption notice will be
processed or, if such day is not a Business Day, then on the
immediately following day that is a Business Day. Any redemption notice
to redeem Units for cash received after such time will be processed in
the next month.
Termination Events
    The Trust will be terminated in the event there are no Units
outstanding, the Trustee resigns or is removed and no successor trustee
is appointed by the Manager by the time the resignation or removal
becomes effective, the Manager resigns and no successor manager is
appointed by the Manager and approved by Unitholders by the time the
resignation becomes effective, the Manager is, in the opinion of the
Trustee, in material default of its obligations under the trust
agreement and does not cure such default within a certain time period,
the Manager experiences certain insolvency events or the assets of the
Manager have become subject to seizure or confiscation by any public or
governmental authority. In addition, the Manager may, in its
discretion, terminate the Trust, without Unitholder approval, if, in
the opinion of the Manager, after consulting with the independent
review committee, the value of net assets of the Trust has been reduced
such that it is no longer economically feasible to continue the Trust
and it would be in the best interests of the Unitholders to terminate
the Trust, by giving the Trustee and each holder of Units at the time
at least 90 days' notice. To the extent such termination in the
discretion of the Manager may involve a matter that would be a
``conflict of interest matter'' as set forth in applicable Canadian
regulations, the matter will be referred by the Manager to the
independent review committee established by the Manager for its
recommendation. In connection with the termination of the Trust, the
Trust shall, to the extent possible, convert its assets to cash and,
after paying or making adequate provision for all of the Trust's
liabilities, distribute the net assets of the Trust to Unitholders, on
a pro rata basis, as soon as practicable after the termination date.
    Additional information regarding the Units and the operation of the
Trust, including termination events, risks, and redemption procedures,
is described in the Registration Statement.
Valuation of Gold and Definition of Net Asset Value
    The value of the net assets of the Trust and the NAV will be
determined daily at 4:00 p.m. (Toronto time) on each day that is a
Business Day, by the Trust's valuator, which is RBC Dexia Investor
Services Trust. The value of the net assets of the Trust as of the
valuation time on any such day shall be equal to the aggregate fair
market value of the assets of the Trust as of such date, less an amount
equal to the total liabilities of the Trust (excluding all liabilities
represented by outstanding Units and deferred taxes) as of such date.
The valuator shall calculate the NAV by dividing the value of the net
assets of the Trust on that day by the total number of Units then
outstanding on such day.
    The Units will be book-entry only and individual certificates will
not be issued for the Units (except in connection with a redemption of
Units, during the process of which redeeming Units will be certificated
and presented for cancellation as part of the redemption process).
Availability of Information Regarding Gold Prices
    Currently, the Consolidated Tape Plan does not provide for
dissemination of the spot price of a commodity, such as gold, over the
Consolidated Tape. However, there will be disseminated over the
Consolidated Tape the last sale price for the Units, as is the case for
all equity securities traded on the Exchange (including exchange-traded
funds). In addition, there is a considerable amount of gold price and
gold market information available on public Web sites and through
professional and subscription services.
    Investors may obtain on a 24-hour basis gold pricing information
based on the spot price for an ounce of gold from various financial
information service

providers, such as Reuters and Bloomberg. Reuters and Bloomberg provide
at no charge on their Web sites delayed information regarding the spot
price of gold and last sale prices of gold futures, as well as
information about news and developments in the gold market. Reuters and
Bloomberg also offer a professional service to subscribers for a fee
that provides information on gold prices directly from market
participants. An organization named EBS provides an electronic trading
platform to institutions such as bullion banks and dealers for the
trading of spot gold, as well as a feed of live streaming prices to
Reuters and Moneyline Telerate subscribers. Complete real-time data for
gold futures and options prices traded on the COMEX are available by
subscription from Reuters and Bloomberg. The NYMEX also provides
delayed futures and options information on current and past trading
sessions and market news free of charge on its Web site. There are a
variety of other public Web sites providing information on gold,
ranging from those specializing in precious metals to sites maintained
by major newspapers, such as The Wall Street Journal. In addition, the
London AM Fix and London PM Fix are publicly available at no charge at
or [sic] http://www.thebulliondesk.com.
    The Trust Web site will provide an intraday indicative value
(``IIV'') per share for the Units, as calculated by a third party
financial data provider during the Exchange's Core Trading Session
(9:30 a.m. to 4 p.m., New York time). The IIV will be calculated based
on a price of gold derived from updated bids and offers indicative of
the spot price of gold.\20\ In addition, the Web site for the Trust
will contain the following information, on a per Unit basis, for the
Trust: (a) The mid-point of the bid-ask price \21\ at the close of
trading in relation to the NAV as of the time the NAV is calculated
(``Bid/Ask Price''), and a calculation of the premium or discount of
such price against such NAV; and (b) data in chart format displaying
the frequency distribution of discounts and premiums of the Bid/Ask
Price against the NAV, within appropriate ranges, for each of the four
previous calendar quarters. The Web site for the Trust will also
provide the Trust's prospectus, as well as the two most recent reports
to stockholders. Finally, the Trust Web site will provide the last sale
price of the Units as traded in the US market. In addition, the
Exchange will make available over the Consolidated Tape quotation
information, trading volume, closing prices and NAV for the Units from
the previous day.
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    \20\ The IIV on a per Unit basis disseminated during the Core
Trading Session should not be viewed as a real-time update of the
NAV, which is calculated once a day.
    \21\ The bid-ask price of the Trust is determined using the
highest bid and lowest offer on the Consolidated Tape as of the time
of calculation of the closing day NAV.
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Criteria for Initial and Continued Listing
    The Trust will be subject to the criteria in NYSE Arca Equities
Rule 8.201(e) for initial and continued listing of the Units.
    A minimum of 1,000,000 \22\ Units will be required to be
outstanding at the start of trading.\23\ The minimum number of Units
required to be outstanding exceeds the requirements that have been
applied to previously listed shares of the streetTRACKS Gold Trust, the
iShares COMEX Gold Trust, the iShares Silver Trust and exchange-traded
funds. A minimum of 400 \24\ Unitholders at the start of trading.\25\
Additionally, it is anticipated that the initial price of a Unit will
be approximately $10.00. The Exchange believes that the anticipated
minimum number of Units outstanding at the start of trading is
sufficient to provide adequate market liquidity. The Trust represented
to the Exchange that, prior to listing, the NAV would be calculated
daily and made available to all market participants at the same time.
The Trust has also represented to the Exchange that, prior to listing,
the IIV will be calculated at least every fifteen seconds and made
available to all market participants at the same time.
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    \22\ The minimum number of Units issued is comparable to the
minimum threshold established for the issuance of equity linked
notes under NYSE Arca Rule 5.2(j)(2).
    \23\ See e-mail, dated December 23, 2009, from Tim Malinowski,
NYSE Arca, to David Liu, Assistant Director, Division of Trading and
Markets, Commission.
    \24\ The minimum number of holders is comparable to the minimum
threshold established for the issuance of equity linked notes under
NYSE Arca Rule 5.2(j)(2).
    \25\ See supra note 23.
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Trading Rules
    The Exchange deems the Units to be equity securities and subject to
the Exchange's existing rules governing the trading of equity
securities. Trading in the Units on the Exchange will occur in
accordance with NYSE Arca Equities Rule 7.34(a). The Exchange has
appropriate rules to facilitate transactions in the Units during all
trading sessions.
    Further, NYSE Arca Equities Rule 8.201 sets forth certain
restrictions on ETP Holders acting as registered Market Makers in the
Units to facilitate surveillance. Pursuant to NYSE Arca Equities Rule
8.201(h), an ETP Holder acting as a registered Market Maker in the
Units is required to provide the Exchange with information relating to
its trading in the underlying gold, related futures or options on
futures, or any other related derivatives. NYSE Arca Equities Rule
8.201(i) prohibits an ETP Holder acting as a registered Market Maker in
the Units from using any material nonpublic information received from
any person associated with an ETP Holder or employee of such person
regarding trading by such person or employee in the underlying gold,
related futures or options on futures or any other related derivative
(including the Units).
    As a general matter, the Exchange has regulatory jurisdiction over
its ETP Holders and their associated persons, which include any person
or entity controlling an ETP Holder, as well as a subsidiary or
affiliate of an ETP Holder that is in the securities business. A
subsidiary or affiliate of an ETP Holder that does business only in
commodities or futures contracts would not be subject to Exchange
jurisdiction, but the Exchange could obtain information regarding the
activities of such subsidiary or affiliate through surveillance sharing
agreements with regulatory organizations of which such subsidiary or
affiliate is a member.
    With respect to trading halts, the Exchange may consider all
relevant factors in exercising its discretion to halt or suspend
trading in the Units. Trading on the Exchange in the Units may be
halted because of market conditions or for reasons that, in the view of
the Exchange, make trading in the Units inadvisable. These may include:
(1) The extent to which conditions in the underlying gold market have
caused disruptions and/or lack of trading, or (2) whether other unusual
conditions or circumstances detrimental to the maintenance of a fair
and orderly market are present. In addition, trading in Units will be
subject to trading halts caused by extraordinary market volatility
pursuant to the Exchange's ``circuit breaker'' rule.\26\
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    \26\ See NYSE Arca Equities Rule 7.12.
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Surveillance
    The Exchange intends to utilize its existing surveillance
procedures applicable to derivative products (including Commodity-Based
Trust Shares) to monitor trading in the Units. The Exchange represents
that these procedures are adequate to properly monitor Exchange trading
of the Units in all trading sessions and to deter and

detect violations of Exchange rules and applicable Federal securities
laws.
    The Exchange's current trading surveillance focuses on detecting
securities trading outside their normal patterns. When such situations
are detected, surveillance analysis follows and investigations are
opened, where appropriate, to review the behavior of all relevant
parties for all relevant trading violations. Also, pursuant to NYSE
Arca Equities Rule 8.201(h), the Exchange is able to obtain information
regarding trading in the Units and the underlying gold, gold futures
contracts, options on gold futures, or any other gold derivative,
through ETP Holders acting as registered Market Makers, in connection
with such ETP Holders' proprietary or customer trades which they effect
on any relevant market. In addition, the Exchange may obtain trading
information via the Intermarket Surveillance Group (``ISG'') from other
exchanges who are members of the ISG.\27\
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    \27\ A list of ISG members is available at http://www.ISGPortal.org. The Exchange notes that the New York Mercantile
Exchange, of which the COMEX is a division, is an ISG member,
however, the TOCOM is not an ISG member and the Exchange does not
have in place a comprehensive surveillance sharing agreement with
such market.
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Information Bulletin
    Prior to the commencement of trading, the Exchange will inform its
ETP Holders in an Information Bulletin of the special characteristics
and risks associated with trading the Units. Specifically, the
Information Bulletin will discuss the following: (1) The procedures for
purchases and redemptions of Units; (2) 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 Units;
(3) how information regarding the IIV is disseminated; (4) the
requirement that ETP Holders deliver a prospectus to investors
purchasing newly issued Units prior to or concurrently with the
confirmation of a transaction; (5) the possibility that trading spreads
and the resulting premium or discount on the Units may widen as a
result of reduced liquidity of gold trading during the Core and Late
Trading Sessions after the close of the major world gold markets; and
(6) trading information. For example, the Information Bulletin will
advise ETP Holders, prior to the commencement of trading, of the
prospectus delivery requirements applicable to the Trust. ETP Holders
purchasing Units from the Trust for resale to investors will deliver a
prospectus to such investors.
    In addition, the Information Bulletin will reference that the Trust
is subject to various fees and expenses described in the Registration
Statement. The Information Bulletin will also reference the fact that
there is no regulated source of last sale information regarding
physical gold, that the Commission has no jurisdiction over the trading
of gold as a physical commodity, and that the CFTC has regulatory
jurisdiction over the trading of gold futures contracts and options on
gold futures contracts.
    The Information Bulletin will also discuss any relief, if granted,
by the Commission or the staff from any rules under the Act.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) \28\ of the Act, in general, and furthers the
objectives of Section 6(b)(5),\29\ in particular, because it is
designed to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in facilitating
transactions in securities, and to remove impediments and perfect the
mechanisms of a free and open market and to protect investors and the
public interest. The Exchange believes that the proposed rule change
will facilitate the listing and trading of an additional type of
commodity-based product that will enhance competition among market
participants, to the benefit of investors and the marketplace.
---------------------------------------------------------------------------

    \28\ 15 U.S.C. 78f(b).
    \29\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

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

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve the proposed rule change, or
    (B) Institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NYSEArca-2009-113 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEArca-2009-113. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Room, 100 F Street,
NE., Washington, DC 20549, on official business days between the hours
of 10 a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at NYSE Arca's principal office and on its
Internet Web site at http://www.nyse.com. All comments received will be
posted without change; the Commission does not edit personal
identifying information from submissions. You should submit only
information that you wish to make available publicly. All submissions

should refer to File Number SR-NYSEArca-2009-113 and should be
submitted on or before January 25, 2010.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\30\
---------------------------------------------------------------------------

    \30\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-31162 Filed 12-31-09; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 107 (Monday, June 7, 2021)]
[Notices]
[Pages 30313-30314]
[FR Doc No: 2021-11851]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2601-068]

Northbrook Carolina Hydro II, LLC, HydroLand Carolinas I, LLC;
Notice of Application for Transfer of License and Soliciting Comments,
Motions To Intervene, and Protests

    On May 13, 2021, Northbrook Carolina Hydro II, LLC (transferor) and
HydroLand Carolinas I, LLC (transferee) filed jointly an application
for the transfer of license of the Bryson Hydroelectric Project No.
2601. The project is located on the Oconaluftee River, near the City of
Bryson, in Swain County, North Carolina.
    The applicants seek Commission approval to transfer the license for
the Bryson Hydroelectric Project from the transferor to the transferee.
    Applicants Contact: For transferor: Mr. Kyle Kroeger, Northbrook
Carolina Hydro II, LLC, c/o North Sky Capital, LLC, 33 South Sixth
Street, Suite 4646, Minneapolis, MN 55402, Email:
<EMAIL_ADDRESS>and Mr. John C. Ahlrichs, Northbrook
Energy, LLC, 14550 N Frank Lloyd Wright Blvd., Suite 210, Scottsdale,
AZ 85260, Email<EMAIL_ADDRESS>with a copy to: Mr. Curt
Whitaker, c/o Rath, Young and Pignatelli, One Capital Plaza, Box 1500,
Concord, NH 03302, Email<EMAIL_ADDRESS>    For transferee: Mr. Cory Lagerstrom, CEO, HydroLand Carolinas I,
LLC, c/o HydroLand, Inc., 4603 Homestead Drive, Prairie Village, KS
66208, Email<EMAIL_ADDRESS>    FERC Contact: Anumzziatta Purchiaroni,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    Deadline for filing comments, motions to intervene, and protests:
30 days from the date that the Commission issues this notice. The
Commission strongly encourages electronic filing. Please file comments,
motions to intervene, and protests using the Commission's eFiling
system at http://www.ferc.gov/docs-

filing/efiling.asp. Commenters can submit brief comments up to 6,000
characters, without prior registration, using the eComment system at
http://www.ferc.gov/docs-filing/ecomment.asp. You must include your
name and contact information at the end of your comments. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY).
    In lieu of electronic filing, you may submit a paper copy.
Submissions sent via U.S. Postal Service must be addressed to, Kimberly
D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First
Street NE, Room 1A, Washington, DC 20426. Submissions sent via any
other carrier must be addressed to, Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville,
Maryland 20852. The first page of any filing should include docket
number P-2601-068. Comments emailed to Commission staff are not
considered part of the Commission record.

    Dated: June 1, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-11851 Filed 6-4-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 29 (Tuesday, February 12, 2013)]
[Rules and Regulations]
[Pages 9796-9798]
[FR Doc No: 2013-02897]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-1273; Directorate Identifier 2012-CE-045-AD;
Amendment 39-17350; AD 2013-03-15]
RIN 2120-AA64

Airworthiness Directives; Cessna Aircraft Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Cessna Aircraft Company Models 172R and 172S airplanes. This AD was
prompted by reports of chafing of a new configuration of the fuel
return line assembly, which was caused by the fuel return line assembly
rubbing against the right steering tube assembly during rudder pedal
actuation. This AD requires you to install the forward and aft fuel
return line support clamps and brackets; inspect for a minimum
clearance between the fuel return line assembly and the steering tube
assembly and clearance between the fuel return line assembly and the
airplane structure; and, if any damage is found, replace the fuel
return line assembly. We are issuing this AD to correct the unsafe
condition on these products.

DATES: This AD is effective March 19, 2013.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in the AD as of March 19,
2013.

ADDRESSES: For service information identified in this AD, contact
Cessna Aircraft Company, Customer service, P.O. Box 7706, Wichita, KS
67277; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>Internet: http://www.cessnasupport.com. You may review copies of the referenced service
information at the FAA, Small Airplane Directorate, 901 Locust, Kansas
City, MO 64106. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The address for the
Docket Office (phone:<PHONE_NUMBER>) is Document Management Facility,
U.S. Department of Transportation, Docket Operations, M-30, West
Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE.,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Jeff Janusz, Aerospace Engineer,
Wichita

Aircraft Certification Office, FAA, 1801 S. Airport Road, Room 100,
Wichita, Kansas 67209; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM published in the Federal Register on December 5, 2012 (77 FR
72250). That NPRM proposed to require you to install the forward and
aft fuel return line support clamps and brackets; inspect for a minimum
clearance between the fuel return line assembly and the steering tube
assembly and clearance between the fuel return line assembly and the
airplane structure; and, if any damage is found, replace the fuel
return line assembly.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM (77 FR 72250, December 5,
2012) or on the determination of the cost to the public.

Conclusion

    We reviewed the relevant data and determined that air safety and
the public interest require adopting the AD as proposed except for
minor editorial changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM (77 FR 72250, December 5, 2012) for correcting the unsafe
condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (77 FR 72250, December 5, 2012).

Costs of Compliance

    We estimate that this AD affects 80 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
               Action                        Labor cost           Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
Installation of brackets and clamps   2 work-hours x $85 per              $78             $248          $19,840
 and inspection of the fuel return     hour = $170.
 line assembly for chafing and
 clearance.
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any necessary replacements
that would be required based on the results of the proposed inspection.
We have no way of determining the number of aircraft that might need
this replacement:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                    Action                                Labor cost               Parts cost        product
----------------------------------------------------------------------------------------------------------------
Replacement of the fuel return line assembly   2 work-hours x $85 per hour =               $53             $223
 and adjustment of the clearance between the    $170.
 fuel return line assembly and the steering
 tube assembly and the airplane structure.
----------------------------------------------------------------------------------------------------------------

     According to the manufacturer, some of the costs of this AD may be
covered under warranty, thereby reducing the cost impact on affected
individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all costs in our cost
estimate.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2013-03-15 Cessna Aircraft Company: Amendment 39-17350; Docket No.

FAA-2012-1273; Directorate Identifier 2012-CE-045-AD.

(a) Effective Date

    This AD is effective March 19, 2013.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to the following Cessna Aircraft Company
(Cessna) airplanes, certificated in any category:
    (1) Model 172R, serial numbers (S/N) 17281573 through 17281616;
and
    (2) Model 172S, S/N l72S11074 through 172S11193.

(d) Subject

    Joint Aircraft System Component (JASC)/Air Transport Association
(ATA) of America Code 2820, Aircraft Fuel Distribution System.

(e) Unsafe Condition

    This AD was prompted by reports of chafing of a new
configuration of the fuel return line assembly, which was caused by
the fuel return line assembly rubbing against the right steering
tube assembly during rudder pedal actuation. We are issuing this AD
to correct the unsafe condition on these products.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Inspect the Fuel Return Line Assembly

    At whichever of the following compliance times that occurs
later, inspect the fuel return line assembly (Cessna part number (P/
N) 0516031-1) for damage following the Accomplishment Instructions
section of Cessna Aircraft Company Service Bulletin SEB-28-01, dated
September 21, 2012.
    (1) At the next annual inspection after March 19, 2013 (the
effective date of this AD);
    (2) Within the next 100 hours time-in-service (TIS) after March
19, 2013 (the effective date of this AD); or
    (3) Within the next 12 calendar months after March 19, 2013 (the
effective date of this AD).

(h) Replace the Fuel Return Line Assembly

    If you find evidence of damage of the fuel return line assembly
(Cessna P/N 0516031-1) as a result of the inspection required by
paragraph (g) of this AD, before further flight, replace the fuel
return line assembly (Cessna P/N 0516031-1) following the
Accomplishment Instructions section of Cessna Aircraft Company
Service Bulletin SEB-28-01, dated September 21, 2012.

(i) Install the Fuel Return Line Assembly

    If you find no evidence of damage of the fuel return line
assembly (Cessna P/N 0516031-1) as a result of the inspection
required by paragraph (g) of this AD, before further flight,
reinstall the fuel return line assembly (Cessna P/N 0516031-1)
following the Accomplishment Instructions section of Cessna Aircraft
Company Service Bulletin SEB-28-01, dated September 21, 2012.

(j) Install Forward and Aft Fuel Return Line Support Clamps and
Brackets

    After installing the fuel return line assembly as required by
replacement in paragraph (h) of this AD or installation in paragraph
(i) of this AD, before further flight, install the forward and aft
fuel return line support clamps and brackets following the
Accomplishment Instructions section of Cessna Aircraft Company
Service Bulletin SEB-28-01, dated September 21, 2012.

(k) Inspect for a Minimum Clearance Between Certain Parts

    After the installation required by paragraph (j) of this AD,
before further flight, inspect for a minimum clearance between the
following parts throughout the range of copilot pedal travel. The
requirements of this AD take precedence over the actions required in
the Accomplishment Instructions section of Cessna Aircraft Company
Service Bulletin SEB-28-01, dated September 21, 2012:
    (1) A minimum clearance of 0.5 inch between the fuel return line
assembly (Cessna P/N 0516031-1) and the steering tube assembly
(Cessna P/N MC0543022-2C); and
    (2) Visible positive clearance between the fuel return line
assembly (Cessna P/N 0516031-1) and the airplane structure.

(l) Adjust Clearance for Fuel Return Line Assembly

    If you find any clearance less than the minimum clearance
required by paragraph (k) of this AD, before further flight, adjust
to the minimum clearance required by paragraph (k) of this AD.

(m) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Wichita Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. In accordance with 14
CFR 39.19, send your request to your principal inspector or local
Flight Standards District Office, as appropriate. If sending
information directly to the manager of the ACO, send it to the
attention of the person identified in the Related Information
section of this AD.
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(l) Related Information

    For more information about this AD, contact Jeff Janusz,
Aerospace Engineer, Wichita ACO, FAA, 1801 S. Airport Road, Room
100, Wichita, Kansas 67209; phone:<PHONE_NUMBER>; fax: (316) 946-
4107; email<EMAIL_ADDRESS>
(m) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Cessna Aircraft Company Service Bulletin SEB-28-01, dated
September 21, 2012.
    (ii) Reserved.
    (3) For Cessna Aircraft Company service information identified
in this AD, contact Cessna Aircraft Company, Customer service, P.O.
Box 7706, Wichita, KS 67277; telephone:<PHONE_NUMBER>; fax: (316)
517-7271<EMAIL_ADDRESS>Internet: http://www.cessnasupport.com.
    (4) You may view this service information at FAA, Small Airplane
Directorate, 901 Locust, Kansas City, MO 64106. For information on
the availability of this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Kansas City, Missouri, on February 4, 2013.
John Colomy,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2013-02897 Filed 2-11-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 239 (Thursday, December 12, 2019)]
[Notices]
[Pages 67939-67940]
[FR Doc No: 2019-26760]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Effectiveness of Exempt Wholesale Generator Status

Thermo Cogeneration Partnership,   EG19-179-000
 L.P.
Peyton Creek Wind Farm, LLC......  EG19-180-000
SR Hazlehurst III, LLC...........  EG19-181-000
Blue Summit III Wind, LLC........  EG19-182-000
Airport Solar LLC................  EG19-183-000
Heart of Texas Wind, LLC.........  EG19-184-000
Isabella Wind, LLC...............  EG19-185-000
224WB 8me LLC....................  EG19-186-000
Bronco Plains Wind, LLC..........  EG19-187-000
Poseidon Wind, LLC...............  EG19-188-000
Bearkat Wind Energy II LLC.......  EG19-189-000
Camilla Solar Energy LLC.........  EG19-190-000
Tenaska Clear Creek Wind, LLC....  EG19-191-000

    Take notice that during the month of November, 2019, the status of
the above-captioned entities as Exempt Wholesale Generators became
effective by operation of the Commission's regulations. 18 CFR 366.7(a)
(2019).

    Dated: December 6, 2019.
Nathaniel J. Davis, Sr.,
 Deputy Secretary.
[FR Doc. 2019-26760 Filed 12-11-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 152 (Wednesday, August 7, 2013)]
[Notices]
[Page 48172]
[FR Doc No: 2013-19053]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0937]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Clinical Laboratory Improvement
Amendments Waiver Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Clinical Laboratory Improvement
Amendments Waiver Applications'' has been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On April 23, 2013, the Agency submitted a
proposed collection of information entitled ``Clinical Laboratory
Improvement Amendments Waiver Applications'' to OMB for review and
clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor,
and a person is not required to respond to, a collection of information
unless it displays a currently valid OMB control number. OMB has now
approved the information collection and has assigned OMB control number
0910-0598. The approval expires on July 31, 2016. A copy of the
supporting statement for this information collection is available on
the Internet at http://www.reginfo.gov/public/do/PRAMain.

    Dated: August 1, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-19053 Filed 8-6-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 83, Number 228 (Tuesday, November 27, 2018)]
[Notices]
[Page 60835]
[FR Doc No: 2018-25808]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL19-18-000]

American Electric Power Service Corporation v. PJM
Interconnection L.L.C.; Notice of Complaint

    Take notice that on November 16, 2018, pursuant to sections 206 and
306 of the Federal Power Act, 16 U.S.C. 824e and 825e, and Rule 206 of
the Federal Energy Regulatory Commission's (Commission) Rules of
Practice and Procedure, 18 CFR 385.206 (2018), American Electric Power
Service Corporation, on behalf of its PJM transmission owners
(Complainant) filed a formal complaint against PJM Interconnection
L.L.C. (PJM or Respondent), alleging that PJM's Open Access
Transmission Tariff is unjust and unreasonable because it does not
include indemnifications provisions that are consistent with the
Commission's pro forma Large Generator Interconnection Agreement, as
more fully explained in the complaint.
    The Complainant certifies that copies of the complaint were served
on the contacts for Respondent, as listed on the Commission's list of
Corporate Officials.
    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. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainant.
    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 electronic 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 protected], or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on December 6, 2018.

    Dated: November 20, 2018.
Kimberly D. Bose,
Secretary.
[FR Doc. 2018-25808 Filed 11-26-18; 8:45 am]
 BILLING CODE 6717-01-P


EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: [PV Shah,<PHONE_NUMBER>]

INSTRUCTIONS:  Please utilize this outline in preparing the pesticide petition.  In cases where the outline element does not apply, please insert "NA-Remove" and maintain the outline. Please do not change the margins, font, or format in your pesticide petition. Simply replace the instructions that appear in green, i.e., "[insert company name]," with the information specific to your action.

TEMPLATE:

Taminco US Inc., a subsidiary of Eastman Chemical Company

IN-10854

	EPA has received a pesticide petition (IN-10854) from SciReg Inc. (12733 Director's Loop, Woodbridge, VA 22192) on behalf of Taminco US Inc., a subsidiary of Eastman Chemical Company, [Two Windsor Plaza, Suite 400, 7450 Windsor Drive, Allentown, PA 18195] proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180.920 to establish an exemption from the requirement of a tolerance for [2-Pyrrolidinone, 1-butyl- (CAS No. 3470-98-2) under 40 CFR 180.920 when used as an inert ingredient (solvent/co-solvent) in pesticide formulations].  EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of  FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

	1. Plant metabolism.

	2. Analytical method. [Taminco is requesting that 2-Pyrrolidinone, 1-butyl- be exempt from the requirement of a tolerance under 40 CFR 180.920. Therefore, Taminco believes that an analytical method to determine residues in treated crops is not relevant.]

	3. Magnitude of residues. [Taminco is requesting that 2-Pyrrolidinone, 1-butyl- be exempt from the requirement of a tolerance under 40 CFR 180.920. Therefore, Taminco believes that data on the magnitude of residues in treated crops is not relevant.]

B. Toxicological Profile

	1. Acute toxicity.  [Acute Oral Toxicity

2-Pyrrolidinone, 1-butyl- was tested for acute oral toxicity in WIST (SPF) rats according to OECD Guideline No. 423 and in compliance with the Swiss Ordinance relating to Good Laboratory Practice which is based on OECD Good Laboratory Practice.

Three female RccHan: WIST (SPF) rats were treated with the test item,  2-Pyrrolidinone, 1-butyl-, by oral gavage at a dose of 2,000 mg/kg body weight and two further groups of three females each were treated with 300 mg/kg body weight of the test item. The test item was formulated in purified water at a concentration of 0.2 g/mL and 0.03 g/mL and administered at a dose volume of 10 mL/kg.

All animals were examined for clinical signs approximately 30 minutes after treatment and again at approximately 1, 2, 3, and 5 hours after treatment on Day 1, and once daily during test Days 2 - 15. Mortality/viability was recorded together with clinical signs twice daily during Days 2 - 15. Body weights were recorded on Day 1 (prior to administration) and on Days 8 and 15. All animals were necropsied and examined macroscopically.

All animals treated with 300 mg/kg of 2-Pyrrolidinone, 1-butyl- survived until the end of the study period. Two females treated with 2,000 mg/kg of the test item died after the administration and one of them was sacrificed in extremis also on the day of treatment. The females treated with 2,000 mg/kg showed shortly after treatment moderate convulsions, tachypnea, prostration, clear lacrimation in both eyes, and were found unconscious; two of them were found dead later. The females treated with 300 mg/kg of the test item had slightly to moderately decreased activity and slightly ruffled fur. The three further females treated with 300 mg/kg had no clinical signs. No clinical signs were observed during Days 2 to 15. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were recorded at necropsy. The median lethal dose of 2-Pyrrolidinone, 1-butyl- after single oral administration to female rats, observed over a period of 14 days is: 300 mg/kg body weight < LD50 (female rat) < 2,000 mg/kg body weight.

Acute Dermal Toxicity

The test item, 2-Pyrrolidinone, 1-butyl-, was tested for acute dermal toxicity in Wistar (RccHan(TM):WIST) rats according to OECD Guideline No. 402 and in compliance with OECD Good Laboratory Practice.

Initially, two animals (one male and one female) were given a single, 24 hour, semi-occluded dermal application of the undiluted test item to intact skin at a dose level of 2,000 mg/kg body weight. Based on the results of the initial test, a further group of eight animals (four males and four females) were similarly treated. Clinical signs and body weight development were monitored during the study. The test sites were examined for evidence of primary irritation once daily for fourteen days. All animals were subjected to gross necropsy.

There were no deaths and no signs of systemic toxicity. Very slight erythema was noted at the test sites of two females. Small superficial scattered scabs and glossy skin were also noted at the test site of one female. No other signs of dermal irritation were noted. Animals showed expected gains in body weight except for two females which showed no gain in body weight or body weight loss during the first week with expected gain in body weight during the second week. No abnormalities were noted at necropsy. Therefore, the acute dermal LD50 for 2-Pyrrolidinone, 1-butyl- was greater than 2,000 mg/kg body weight.

Primary Eye Irritation

2-Pyrrolidinone, 1-butyl- was tested for acute ocular irritation in three male New Zealand White rabbits according to EPA Guideline OPPTS 870.2400 and in compliance with EPA (40 CFR Parts 160 and 792) and OECD Good Laboratory Practice.

Each of three rabbits received a single 0.1 mL dose of the test substance, 2-Pyrrolidinone, 1-butyl-, in the conjunctival sac of the right eye. The contralateral eye of each animal remained untreated and served as a control. Test and control eyes were examined for signs of irritation for up to 10 days following dosing. Animals were observed for general health/mortality and moribundity twice daily throughout the study.

Exposure to the test article produced corneal opacity in 1/3 test eyes by the 24 hour scoring interval and complete resolution occurred by the Day 7 scoring interval. Iritis was observed in 1/3 test eyes by the 1 hour scoring interval and in 2/3 test eyes by the 24 hour scoring interval. Complete resolution of the iritis occurred in 1/3 test eyes by the Day 7 scoring interval and in 2/3 test eyes by the Day 10 scoring interval. Conjunctivitis (redness, swelling, and/or discharge) occurred in 3/3 test eyes by the 1 hour scoring interval and complete resolution occurred in 1/3 test eyes by the Day 7 scoring interval and in 2/3 test eyes by the Day 10 scoring interval. An additional ocular finding of neovascularization (2/3 test eyes) was noted during the study. Decreased fecal output was observed in all animals. This observation, which is a known pharmacological effect of opioids, was likely due to the buprenorphine treatment that the animals received from Days 0 to 5. According to the Kay and Calandra Evaluation Criteria, 2-Pyrrolidinone, 1-butyl- is considered to be a moderate irritant to the ocular tissue of the rabbit.

Primary Dermal Irritation

2-Pyrrolidinone, 1-butyl- was tested for acute skin irritation in three male New Zealand White rabbits according to EPA Guideline OPPTS 870.2500 and in compliance with EPA (40 CFR Parts 160 and 792) and OECD Good Laboratory Practice.

Each of three rabbits received a 0.5 mL dose of the test substance, 2-Pyrrolidinone, 1-butyl-, as a single dermal application. The dose was held in contact with the skin under a semi-occlusive binder for exposure periods of 3 minutes, 1 hour, and 4 hours for one animal and an exposure period of 4 hours for two animals. Following the completion of each exposure period, the binder was removed and the remaining test substance was wiped from the skin using gauze moistened with deionized water followed by dry gauze. Test sites were subsequently examined and scored for dermal irritation for up to 21 days following patch removal.

Three-Minute Exposure: Exposure to the test substance produced no erythema or edema through 72 hours postdose; however, very slight erythema was noted at the single test site on Day 14, which subsequently resolved by Day 21.

One-Hour Exposure: Exposure to the test substance produced very slight erythema at the single test site immediately after patch removal. The dermal irritation was not observed at the 1-hour scoring interval, but was present again at the 24-, 48-, and 72-hour scoring intervals. The dermal irritation was not observed on Day 7, but was observed again on Day 14. Day 21 scoring revealed no irritation. Additional dermal findings included desquamation.

Four-Hour Exposure: Exposure to the test substance produced very slight erythema at 3/3 test sites and very slight edema at 1/3 test sites by the 1-hour scoring interval. Well-defined erythema was observed in 1/3 test sites at the 24-, 48-, and 72-hour scoring intervals. The dermal irritation was not observed in 1/3 test sites on Day 7, but was again observed in that animal on Day 10. Dermal irritation did not resolve completely in the remaining two test sites. Additional dermal findings included blanching (focal and/or pinpoint areas up to 10% of the test site) in 1/3 test sites and desquamation in 3/3 test sites. Under the conditions of the test (4-hour exposure), 2-Pyrrolidinone, 1-butyl- is considered to be a slight irritant to the skin of the rabbit. The calculated Primary Irritation Index (P.I.I.) for the test substance was 1.33.

Dermal Sensitization

Two dermal sensitization studies were conducted with 2-Pyrrolidinone, 1-butyl-. Taminco is relying on the second study for the following reasons. A local lymph node assay in mice was previously conducted at LPT Laboratory of Pharmacology and Toxicology GmbH & Co. KG ("LPT") in April 2013.  Subsequent review of this study revealed significant deviations from the OECD Guideline 429, as well as significant concerns with the quality of the work. Per the Guideline, a laboratory may deviate from a requirement when there is a valid reason which should be stated and supported in the final report. In the case of the LPT Study, there were a number of significant deviations from the Guideline that were not supported in the final report including, but not limited to the following:

    Use of lymph node weight as the metric for cellular proliferation instead of more sensitive metrics such as radiolabeled thymidine as prescribed by the Guideline or flow cytometric analysis of isolated cells.     Use of a customized Stimulation Index instead of the index specified by the Guideline.     Study duration of four days instead of six days as specified by the Guideline.

Each of these deviations from the Guideline is significant and was not justified by the laboratory. Moreover, Taminco does not believe that any of these deviations were necessary and that the test article could have been accurately assessed within the requirements of the Guideline.

Taminco also has significant concerns with the quality of the work performed by LBT. The most conspicuous example involves the reproducibility of the results wherein certain concentrations of the test article that were not irritating in the range finder were subsequently found to be irritating in the actual study. The inability of the laboratory to reproduce findings for a simple endpoint raises significant concerns regarding the quality of work done in performance of this study.

Given the significant deviations from the Guideline and the concerns regarding the quality of the work, Taminco conducted another local lymph node assay in the mouse in accordance with the Guideline OECD 429, and wishes to rely on the results of this study to support the tolerance exemption for 2-Pyrrolidinone, 1-butyl-. Both dermal sensitization studies are summarized below.

Dermal Sensitization Study #1

The test item, 2-Pyrrolidinone, 1-butyl-, was assessed for skin sensitization potential in female NMRI mice, using the local lymph node assay.

This study did not employ the use of radioactive labelling to measure cell proliferation.  An alternative method was used employing lymph node weight and lymph node cell count. This method was established by a European interlaboratory validation exercise. In addition, the acute inflammatory skin reaction was measured by ear weight determination of circular biopsies of the ears and ear thickness measurements on test day one and test day four to identify skin irritation properties of the test item. Values above 1.4 (lymph node cell count to identify sensitisation) or 1.1 (ear weight to identify irritation) were considered positive.

Five concentrations of the test item (1%, 5%, 10%, 25%, and 50% w/w) diluted with acetone/olive oil (3+1 v/v) were tested in six female NMRI mice per group and compared to a vehicle control group. In addition, a positive control group [25% solution v/v of α-hexyl cinnamic aldehyde in acetone/olive oil (3+1 v/v)] was tested.

The positive control group caused the expected increases in lymph node cell count and lymph node weight (statistically significant at p <= 0.01). Therefore, the study was regarded as valid.

Treatment with 2-Pyrrolidinone, 1-butyl- at concentrations of 1% and 5% did not reveal statistically significant increased values for lymph node cell count and lymph node weight. The stimulation indices of the lymph node cell count did not exceed the threshold level of 1.4. Therefore, the test item was classified as not sensitizing. The threshold level for the ear weight of 1.1 was not exceeded and no increase of ear thickness was observed.

Treatment with 2-Pyrrolidinone, 1-butyl- at concentrations of 10, 25, and 50% (w/w) revealed statistically significant increased values (p <= 0.01 or p <= 0.05) for lymph node cell count and lymph node weight. However, ear weights were also significantly increased at these concentrations pointing to strongly irritating properties on the mouse ear. The stimulation indices of the lymph node cell count (sensitizing properties) and ear weight (irritation properties) exceeded the threshold levels of 1.4 or 1.1.

No signs of local or systemic intolerance were recorded. Body weight was not affected by the treatment.

2-Pyrrolidinone, 1-butyl- did not reveal any sensitizing properties in the local lymph node assay at concentrations of 1% or 5% (w/w) in acetone/olive oil (3 + 1 v/v). Concentrations of 10% or higher did not permit an evaluation due to the irritating properties of the test item shown through increased ear weight and an increase in ear thickness.

Dermal Sensitization Study #2

The test item, 2-Pyrrolidinone, 1-butyl-, was assessed for skin sensitization potential in CBA/Ca strain mice using the local lymph node assay according to OECD Guideline 429 and in compliance with OECD Good Laboratory Practice.

Following a preliminary screening test in which no clinical signs of toxicity were noted at a concentration of 50% v/v, this concentration was selected as the highest dose investigated in the main test of the local lymph node assay. Three groups, each of five animals, were treated with 50 μL (25 μL per ear) of the test item as a solution in acetone/olive oil 4:1 at concentrations of 50%, 25% or 10% v/v. A further group of five animals was treated with acetone/olive oil 4:1 alone. A concurrent positive control test, using a group of five animals, was also performed with the known sensitizer, a-Hexylcinnamaldehyde tech., 85%, at a concentration of 25% v/v in acetone/olive oil 4:1. The test item was applied topically to the dorsal surface of the ear.

The Stimulation Index expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group was as follows: 0.70, 0.91, and 1.22 for the 10%, 25%, and 50% treatment groups, respectively. The Stimulation Index for the positive control was 5.39.

Therefore, the test item was considered to be a non-sensitizer under the conditions of the test. a-Hexylcinnamaldehyde, tech., 85% gave a Stimulation Index of greater than 3 when tested at a concentration of 25% v/v in acetone/olive oil 4:1.]

	2. Genotoxicty. [Bacterial Reverse Mutation Test

The mutagenic potential of 2-Pyrrolidinone, 1-butyl- was assessed in the Salmonella typhimurium reverse mutation assay according to OECD Guideline 471 and in compliance with OECD Good Laboratory Practice.

Salmonella typhimurium strains TA98, TA100, TA102, TA1535, and TA1537 were tested in the presence and absence of metabolic activation from a microsomal preparation derived from Aroclor 1254-induced rat liver. The first experiment was carried out as a plate incorporation test and the second as a preincubation test. Doses ranged from 31.6 to 5,000 ug 2-Pyrrolidinone, 1-butyl-/plate.

2-Pyrrolidinone, 1-butyl- up to 5,000 ug/plate caused no mutagenic effects in the plate incorporation and preincubation tests, with or without metabolic activation.

In Vitro Mammalian Cell Gene Mutation Test

The mutagenic potential of the test item, 2-Pyrrolidinone, 1-butyl-, was assessed on the thymidine kinase, TK+/- locus of the L5178Y mouse lymphoma cell line according to OECD Guideline 476 and in compliance with OECD Good Laboratory Practice.

Two independent experiments were performed. In Experiment 1, L5178Y TK +/- 3.7.2c mouse lymphoma cells (heterozygous at the thymidine kinase locus) were treated with the test item at six dose levels, in duplicate, together with vehicle (solvent) and positive controls using 4-hour exposure groups, both in the absence and presence of metabolic activation (2% S9). In Experiment 2, the cells were treated with the test item at six dose levels using a 4-hour exposure group in the presence of metabolic activation (1% S9) and a 24-hour exposure group in the absence of metabolic activation. The doses of test item used in both tests (44.1, 88.2, 176.4, 352.8, 705.6, and 1,411.2 ug/mL) were selected following the results of a preliminary toxicity test.

The maximum dose level used in the main test was the 10 mM Maximum Recommended Dose level. No precipitate of test item was observed. Negative (vehicle) and positive controls responded adequately. The study was, therefore, considered valid.

2-Pyrrolidinone, 1-butyl- did not induce any toxicologically significant or dose-related (linear-trend) increases in the mutant frequency at any of the dose levels, either with or without metabolic activation, in either the first or the second experiment. Therefore, 2-Pyrrolidinone, 1-butyl- is considered to be non-mutagenic under the conditions of the test.

In Vitro Mammalian Cell Micronucleus Test

The clastogenic and aneugenic potential of the test item, 2-Pyrrolidinone, 1-butyl-, was tested on the nuclei of normal human lymphocytes according to OPPTS Guideline 870.5300 and in compliance with OECD Good Laboratory Practice.

Duplicate cultures of human lymphocytes, treated with the test item, were evaluated for micronuclei in binucleate cells at multiple dose levels, together with vehicle and positive controls. The dose levels (44.1, 88.2, 176.4, 352.8, 705.6, 1,411.2 ug/mL) were selected using data from a preliminary toxicity test. Experiment 1 used a 4-hour exposure in the presence and absence of a standard metabolizing system (2% S9). Experiment 2 used a 24-hour exposure in the absence of metabolic activation and was performed concurrently with the exposure groups of Experiment 1. At the end of the exposure period, the cell cultures were washed and then incubated for a further 28 hours in the presence of Cytochalasin B.

Negative (solvent) and positive controls responded adequately. The study was, therefore, considered valid.

2-Pyrrolidinone, 1-butyl- did not induce any statistically significant increases in the frequency of cells with micronuclei, in either of the two experiments, using a dose range that included the maximum recommended dose level. 2-Pyrrolidinone, 1-butyl- was considered to be non-clastogenic and non-aneugenic to human lymphocytes in vitro.]

	3. Reproductive and developmental toxicity. [Prenatal Development

Prenatal development was evaluated with the test item, 2-Pyrrolidinone, 1-butyl-, in accordance with OECD Guideline 414 and in compliance with OECD Good Laboratory Practice.

Pregnant Crl:CD(SD) rats were exposed to the test item or vehicle control (tap water) at concentrations of 0, 5, 50, or 500 mg/kg bw/day by oral gavage on Days 6 to 19 of gestation.

Animals were observed daily for mortality and clinical signs. Body weights were recorded on Day 0 of gestation and daily thereafter. Food consumption was measured daily. On Day 20 of gestation, rats were sacrificed and examined macroscopically. The gravid uterus weight was determined. The placenta was observed for focal indurations, number of fetuses (alive and dead), and number and size of resorptions. Corpora lutea in the ovaries, and implantations and location of fetuses in the uterus were determined. Sex and viability of fetuses were also determined. Fetus weights and weights of the placentae were taken. Fetuses were examined for skeletal and soft tissue retardations, variations, or malformations.

No mortality was observed and no signs of toxicity were noted in dams treated with 2-Pyrrolidinone, 1-butyl- up to 500 mg/kg bw/day. At 500 mg/kg bw/day, a slight, but statistically significant reduction in body weight was noted from gestation Day 7 to gestation Day 20. Body weight gain was statistically significantly reduced in dams treated with 500 mg/kg bw/day between gestation Days 6 and 9. A statistically significant reduction in the net body weight change and absolute body weight change was noted for dams treated with 500 mg/kg bw/day from gestation Day 6 until the day of necropsy. A reduction in food consumption was noted after the start of treatment on gestation Day 7 and on gestation Day 8 in dams treated with 500 mg/kg bw/day. Thereafter, a normal level of food intake was reached. No macroscopic findings were noted. A reduced gravid uterus weight and carcass weight were noted at necropsy for dams treated with 500 mg/kg bw/day. No test item-related changes were noted for the number of corpora lutea, implantation sites, resorptions, and live and dead fetuses. The percentages of pre- and post-implantation loss were also not influenced by the test item. No dead fetuses and no test item-related influence on sex distribution were noted. No test item-related influence was noted on the mean placental weights or mean fetal weights per dam. No test item-related malformations, variations, or retardations were noted in the fetuses during external/internal examination, skeletal examination, and/or soft tissue evaluation.

Therefore, the NOAEL for administration of 2-Pyrrolidinone, 1-butyl- was determined to be 50 mg/kg bw/day for the dams and greater than 500 mg/kg bw/day for the fetuses.

Benchmark Dose (BMD) Modeling Support for n-Butylpyrrolidone

Toxicology Excellence for Risk Assessment (TERA) evaluated the critical effects of  2-Pyrrolidinone, 1-butyl- in a range-finding and a prenatal developmental study in CD rats to 1) determine the key study with data appropriate for conducting benchmark dose (BMD) modeling, 2) identify the data for modeling, and 3) conduct the modeling.

Initial modeling was conducted using the continuous models in U.S. EPA's BMD modeling software (BMDS version 2.5.0) for the mean and individual data for fetal body weights and gravid uterine weights. A benchmark response (BMR) of 5%, the standard BMR for developmental toxicity studies was modeled along with one standard deviation for comparison. Several of the models for the BMR of 5% and 1 standard deviation model runs fit the data well, and criteria for all of these models were comparable. The ranges of BMDs and benchmark dose model lower confidence limits (BMDLs) varied from 196 to 308 mg/kg-day. An average within these ranges would be an acceptable choice for a point of departure. For a BMR of one standard deviation, the average BMD is 394 mg/kg-day and the average BMDL is 250 mg/kg-day. For a BMR of 5%, the average BMD is 306 mg/kg-day and the average BMDL is 201 mg/kg-day. In this case, the BMDL of 201 mg/kg-day for a 5% response is recommended because the modeling was based on a BMR of 5% decreased fetal body weight, which is more biologically appropriate than the use of 1 standard deviation.]

	4. Subchronic toxicity. [90-day Oral  -  rat

A subchronic oral toxicity study was conducted with the test item, 2-Pyrrolidinone, 1-butyl-, according to OECD Guideline 408 and in compliance with OECD Good Laboratory Practice.

Ten male and ten female Wistar Han(TM):RccHan(TM):WIST strain rats were assigned to each dose level (0, 10, 100, and 500 mg/kg bw/day) and were administered vehicle (distilled water) or test item daily by oral gavage for ninety days. Animals were observed daily, and body weight, food consumption, and functional observations were recorded weekly for all animals. Estrous cycle was evaluated for all females during the last three weeks of the study. After 13 weeks of treatment, ophthalmoscopic exams were conducted on the control and high dose animals, and hematology and chemistry, were analyzed for all animals. At termination, all animals were sacrificed and necropsied. All animals were subject to macroscopic examination and select organ weights were taken. Males were also subject to sperm assessment. Microscopic examination was performed on select tissues from all animals in the control and high does groups. Also, the liver and thymus were examined from all animals in the low and intermediate dose groups, and the kidney was examined from males only in the low and intermediate dose groups.

No mortality was observed with treatment of 2-Pyrrolidinone, 1-butyl- up to 500 mg/kg bw/day. Neither the type, incidence or distribution of clinical signs apparent indicated an adverse effect of treatment at 10, 100, or 500 mg/kg bw/day. There were no toxicologically significant changes in the behavioral parameters measured, functional performance or sensory reactivity at 10, 100, or 500 mg/kg bw/day. There were no adverse effects of treatment on body weight development, food consumption or food efficiency, or water consumption at 10, 100, or 500 mg/kg bw/day. There were no treatment-related ocular effects and no adverse effects were detected during the estrous cycle assessments or in sperm concentration, morphological assessments, or in homogenization-resistant spermatid counts. There were no toxicologically significant effects of treatment on the hematology parameters measured. Males treated with 500 mg/kg bw/day showed a statistically significant increase in total protein, calcium, creatinine, and bile acid, and a statistically significant reduction in albumin/globulin ratio. Females treated with 500 mg/kg bw/day showed a statistically significant reduction in albumin/globulin ratio, chloride, and alkaline phosphatase and a statistically significant increase in cholesterol, bilirubin, and bile acid. Males treated with 100 mg/kg bw/day showed a statistically significant increase in chloride. Eight males treated with 500 mg/kg bw/day had enlarged livers at necropsy. No toxicologically significant macroscopic findings were evident in females treated with 500 mg/kg bw/day or in animals of either sex treated with 10 or 100 mg/kg bw/day. Animals of either sex treated with 500 mg/kg bw/day and males treated with 100 mg/kg bw/day had a statistically significant increase in kidney and liver weights, both absolute and relative to terminal body weight. No such effects were evident in females treated with 100 mg/kg bw/day or animals of either sex treated with 10 mg/kg bw/day. Liver hypertrophy or centrilobular hypertrophy was observed in males and females treated with 500 mg/kg bw/day and in males treated with 100 mg/kg bw/day.  An increase in incidence and severity of hyaline droplet accumulation, multifocal basophilic tubules (degenerating/regenerating), and the presence of proteinaceous casts in the tubules of kidneys of males were observed at 100 mg/kg bw/day and above. Minimal atrophy in the thymus was noted in males and females treated with 500 mg/kg bw/day and in males treated with 100 mg/kg bw/day. Vacuolation in the adrenal cortex was present in males only at an increased incidence and severity at 100 mg/kg bw/day and above. One male treated with 10 mg/kg bw/day had vacuolation above the expected level; however, the toxicological significance of this in only one male is equivocal.

Oral administration of 2-Pyrrolidinone, 1-butyl- to rats by gavage for a period of ninety consecutive days at dose levels of 10, 100, and 500 mg/kg bw/day resulted in treatment related effects in animals of either sex treated with 500 mg/kg bw/day and males treated with 100 mg/kg bw/day. The NOEL was considered to be 10 mg/kg bw/day for males and 100 mg/kg bw/day for females. The following effects were considered to be treatment-related and adaptive in nature and, therefore, not adverse: 1) the microscopic liver changes in animals of either sex treated with 500 mg/kg bw/day and males treated with 100 mg/kg bw/day, and the associated blood chemistry changes identified in animals of either sex treated with 500 mg/kg bw/day were likely a represent an adaptive response to treatment and, therefore, considered not to represent a serious risk to health, 2) the microscopic changes in the adrenals of males treated with 500 and 100 mg/kg bw/day and the microscopic thymus changes are likely the result of the adaptive changes apparent in the liver or a secondary stress related response. In terms of extrapolation to man, and risk assessment calculations, the effects relating to renal changes in the male rat are species- and sex-specific and, therefore, are not relevant. For these reasons, the NOAEL was considered to be 500 mg/kg bw/day for animals of either sex.]

	5. Chronic toxicity. [Carcinogenicity

The 90-day toxicity study in rats (Harlan Laboratories Ltd. Study No. 41303953; Volume 19) provided a basis for evaluation of the carcinogenic potential of 2-Pyrrolidinone, 1-butyl-. In that study, the liver, kidney, thymus, and adrenals were target organs for toxicity. Evaluation of the database for n-methylpyrrolidone (NMP) shows similar target organ toxicity as 2-Pyrrolidinone, 1-butyl- and 1-ethylpyrrolidin-2-one (NEP), as both chemicals are considered suitable surrogates for evaluation. Neither 2-Pyrrolidinone, 1-butyl-, n-methylpyrrolidone, nor 1-ethylpyrrolidin-2-one was found to be genotoxic or mutagenic in a number of assays. In carcinogenicity studies, n-methylpyrrolidone was not carcinogenic in two year rat studies by the inhalation dietary routes. An increased incidence of liver adenomas and carcinomas were seen in mice exposed to a dietary level of n-methylpyrrolidone exceeding 1,000 mg/kg/day for 18 months. No tumors were seen at lower concentrations. Liver tumor induction in mice and its relevance to humans has been an area of great debate for decades. A mode of action study with n-methylpyrrolidone at the high dose used in the mouse oncogenicity study strongly suggests that exposure to n-methylpyrrolidone at high concentrations leads to a mitogenic burst in the mouse liver that ultimately may lead to a tumorigenic response in the liver. This mode of action has been proposed for phenobarbital. Based on the lack of mutagenicity or genotoxicity and the similarity of 2-Pyrrolidinone, 1-butyl- to n-methylpyrrolidone, it can be concluded that  2-Pyrrolidinone, 1-butyl- should not be considered as potentially carcinogenic. Further, liver changes seen in the studies were considered as adaptive, nonadverse findings. Kidney pathological lesions were consistent with hydrocarbon nephropathy in male rats induced by α-2-microglobulin accumulation, a finding that is considered as not relevant to humans. The only evidence of a tumorigenic response was seen at an exceedingly high dose in mice treated with  n-methylpyrrolidone.]

	6. Animal metabolism. [NA-Remove.]

	7. Metabolite toxicology. [NA-Remove.]

	8. Endocrine disruption. [There is no available evidence demonstrating that  2-Pyrrolidinone, 1-butyl- is an endocrine disruptor in humans.]

C. Aggregate Exposure

	1. Dietary exposure. [In examining aggregate exposure, section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA) directs EPA to consider available information concerning exposures from the pesticide residue in food and all other nonoccupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses).

It is anticipated that 2-Pyrrolidinone, 1-butyl- will be used as a solvent/co-solvent in pesticide formulations at a concentration no higher than 75% with a potential end-use pesticide rate up to 4 pints/acre. 2-Pyrrolidinone, 1-butyl- is not expected to be persistent in the environment. Further, 2-Pyrrolidinone, 1-butyl- has a low toxicity profile as demonstrated through acute, subchronic, reproductive, developmental, and mutagenicity testing, and evaluation of its carcinogenicity potential. Therefore, dietary exposure to 2-Pyrrolidinone, 1-butyl- should not be of concern.

2-Pyrrolidinone, 1-butyl- is not intended for direction application to water. Agricultural practices minimize spray drift and typical end-use product labels prohibit direct application to water. 2-Pyrrolidinone, 1-butyl- is ultimately biodegradable and is not expected to be persistent in the environment. Therefore, use of 2-Pyrrolidinone, 1-butyl- as a solvent/co-solvent in pesticide formulations does not pose a risk to drinking water.

Overall, 2-Pyrrolidinone, 1-butyl- is considered to be a low toxicity substance with a reasonable certainty of no harm from dietary exposure and all other nonoccupational sources of exposure.]

	i. Food. [NA-Remove.]

	ii. Drinking water. [NA-Remove.]

	2. Non-dietary exposure. [NA-Remove.]

D. Cumulative Effects

	[Section 408(b)(2)(D)(v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider available information concerning the cumulative effects of the particular pesticide's residues and other substances that have a common mechanism of toxicity.

Taminco has not found 2-Pyrrolidinone, 1-butyl- to share a common mechanism of toxicity with any other substances, and 2-Pyrrolidinone, 1-butyl- does not appear to produce a toxic metabolite produced by other substances.

Resultant risks, separately and/or combined with other substances that may have a common mechanism of toxicity, should be low for 2-Pyrrolidinone, 1-butyl-. Taminco does not expect any adverse cumulative effects associated with the use of 2-Pyrrolidinone, 1-butyl-.]

E. Safety Determination

	1. U.S. population. [2-Pyrrolidinone, 1-butyl- exhibits a low toxicity profile,  as demonstrated by the acute, mutagenicity, subchronic, reproductive, and developmental studies summarized above, as well as the evaluation of its carcinogenetic potential.

When 2-Pyrrolidinone, 1-butyl- is used on raw agricultural commodities in accordance with good agricultural practice, it is expected to meet EPA's reasonable certainty of no harm requirement. Based on the low toxicity profile of 2-Pyrrolidinone, 1-butyl-, there is no reason to believe that adverse effects on the U.S. population will result from the use of this inert ingredient in pesticide formulations. In addition, there is no information or data to suggest that infants and children will be disproportionately at risk to the use of 2-Pyrrolidinone, 1-butyl- in pesticide formulations.]

	2. Infants and children. [NA-Remove.]

F. International Tolerances

	[There are no known U.S. or international tolerances or tolerance exemptions for 2-Pyrrolidinone, 1-butyl-.

The similar substance, n-methylpyrrolidone (NMP), is exempt from the requirement of a tolerance under 40 CFR 180.920 when used as solvent or cosolvent in pesticide formulations.]