[Federal Register Volume 86, Number 39 (Tuesday, March 2, 2021)]
[Notices]
[Pages 12245-12250]
[FR Doc No: 2021-04222]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-91205; File No. SR-NASDAQ-2020-057]

Self-Regulatory Organizations; The Nasdaq Stock Market LLC;
Notice of Filing of Proposed Rule Change, as Modified by Amendment No.
1, To Allow Companies To List in Connection With a Direct Listing With
a Primary Offering in Which the Company Will Sell Shares Itself in the
Opening Auction on the First Day of Trading on Nasdaq and To Explain
How the Opening Transaction for Such a Listing Will Be Effected

February 24, 2021.
    On September 4, 2020, The Nasdaq Stock Market LLC (``Nasdaq'' or
the ``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to allow companies to list in connection with a
primary offering in which the company will sell shares itself in the
opening auction on the first day of trading on the Exchange and to
explain how the opening transaction for such a listing will be
effected. The proposed rule change was published for comment in the
Federal Register on September 21, 2020.\3\ On November 4, 2020,
pursuant to Section 19(b)(2) of the Act,\4\ the Commission designated a
longer period within which to either approve or disapprove the proposed
rule change, or institute proceedings to determine whether to
disapprove the proposed rule change.\5\ On December 17, 2020, the
Commission instituted proceedings under Section 19(b)(2)(B) of the Act
\6\ to determine whether to approve or disapprove the proposed rule
change.\7\ On February 22, 2021, the Exchange filed Amendment No. 1 to
the proposed rule change, which superseded the proposed rule change as
originally filed, and is described in Items I and II below, which Items
have been prepared by the Exchange. The Commission is publishing this
notice to solicit comments on the proposed rule change, as modified by
Amendment No. 1, from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 89878 (September 15,
2020), 85 FR 59349 (September 21, 2020). Comments received on the
proposal are available on the Commission's website at: https://www.sec.gov/comments/sr-nasdaq-2020-057/srnasdaq2020057.htm.
    \4\ 15 U.S.C. 78s(b)(2).
    \5\ See Securities Exchange Act Release No. 90331 (November 4,
2020), 85 FR 71708 (November 10, 2020).
    \6\ 15 U.S.C. 78s(b)(2)(B).
    \7\ See Securities Exchange Act Release No. 90717 (December 17,
2020), 85 FR 84025 (December 23, 2020).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to allow companies to list in connection with
a primary offering in which the company will sell shares itself in the
opening auction on the first day of trading on Nasdaq and to explain
how the opening transaction for such a listing will be effected.
    The text of the proposed rule change is available on the Exchange's
website at https://listingcenter.nasdaq.com/rulebook/nasdaq/rules, at
the principal office of the Exchange, and at the Commission's Public
Reference Room.

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

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

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

1. Purpose
    Nasdaq is filing this amendment to SR-NASDAQ-2020-057 \8\ in order
to: (i) Require for the security to be released for trading that the
actual price calculated by the cross be at or above the lowest price
and at or below the highest price of the price range established by the
issuer in its effective registration statement; (ii) provide that the
fourth tie-breaker used in calculating the Current Reference Price is
the price that is closest to the lowest price of the price range
disclosed by the issuer in its effective registration statement; (iii)
provide that for purposes of qualifying a security under the Listing
Rules Nasdaq will calculate the value of shares, and determine whether
the company has met the applicable Market Value of Unrestricted
Publicly Held Shares, bid price and market capitalization requirements,
using a price per share equal to the lowest price in the price range
disclosed by the issuer in its effective registration statement; (iv)
provide that notwithstanding the provisions of Rule 4120(c)(8)(A),
Nasdaq, in consultation with the financial advisor to the issuer, will
make the determination of whether the security is ready to trade and
whether to reschedule the offering as described in Rule 4120(c)(8)(A);
and make minor technical changes to improve the clarity of this
proposal. Nasdaq believes that this amendment addresses the issues
raised by the Commission in the OIP.\9\ This amendment supersedes and
replaces the Initial Proposal in its entirety.
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    \8\ Securities Exchange Act Release No. 89878 (September 15,
2020), 85 FR 59349 (September 21, 2020) (the ``Initial Proposal'').
The Commission issued an Order Instituting Proceedings to Determine
Whether To Approve or Disapprove the Initial Proposal. See
Securities Exchange Act Release No. 90717 (December 17, 2020), 85 FR
84025 (December 23, 2020) (the ``OIP'').
    \9\ Following approval of this proposed rule change Nasdaq
intends to file a separate proposal with the Commission that will
seek to modify the process for a Direct Listing with a Capital Raise
so that it would operate in a manner similar to the Initial Proposal
and will seek to address the remaining issues raised in the OIP.
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    Nasdaq proposes to (i) adopt Listing Rule IM-5315-2 to permit a
company to list in connection with a primary offering in which the
company will sell shares itself in the opening auction on the first day
of trading on the Exchange (a ``Direct Listing with a Capital Raise'');
\10\ (ii) amend Rule 4702 to add a new order type (the ``Company Direct
Listing Order''), which will be used during the Nasdaq Halt Cross for
the shares offered by the company in a Direct Listing with a Capital
Raise; and (iii) amend Rules 4120(c)(9), 4753(a)(3) and 4753(b)(2) to
establish requirements for disseminating information, establishing the
opening price and initiating trading through the Nasdaq Halt Cross in a
Direct Listing with a Capital Raise.
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    \10\ A Direct Listing with a Capital Raise includes situations
where either: (i) Only the company itself is selling shares in the
opening auction on the first day of trading; or (ii) the company is
selling shares and selling shareholders may also sell shares in such
opening auction.
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Proposed Listing Rule IM-5315-2
    Listing Rule IM-5315-1 provides additional initial listing
requirements for listing a company that has not previously had its
common equity securities registered under the Act on the Nasdaq Global
Select Market at the time of effectiveness of a registration statement
filed solely for the purpose of allowing existing shareholders to sell
their shares (a ``Direct Listing''). To

allow a company to also sell shares on its own behalf in connection
with its initial listing upon effectiveness of a registration
statement, without a traditional underwritten public offering, the
Exchange proposes to adopt Listing Rule IM-5315-2.\11\ This proposed
rule would allow a company that has not previously had its common
equity securities registered under the Act to list its common equity
securities on the Nasdaq Global Select Market at the time of
effectiveness of a registration statement pursuant to which the company
itself will sell shares in the opening auction on the first day of
trading on the Exchange.
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    \11\ The Commission did not identify any concerns with proposed
Listing Rule IM-5315-2 in the OIP. Accordingly, the only change to
proposed IM-5315-2 in this amendment is to reflect that the minimum
price at which the company can sell shares is the lowest price in
the price range disclosed by the issuer in its effective
registration statement. In the Initial Proposal, Nasdaq proposed to
allow the company to sell shares at up to a 20% discount to the
lowest price in the price range disclosed in the effective
registration statement and therefore also to calculate compliance
with the listing requirements based on that same price.
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    In considering the initial listing of a company in connection with
a Direct Listing on the Nasdaq Global Select Market, Listing Rule IM-
5315-1 currently provides that the Exchange will determine that such
company has met the applicable Market Value of Unrestricted Publicly
Held Shares requirements based on the lesser of: (i) An independent
third-party valuation of the company (a ``Valuation''); \12\ and (ii)
the most recent trading price for the company's common stock in a
Private Placement Market where there has been sustained recent trading.
For a security that has not had sustained recent trading in a Private
Placement Market \13\ prior to listing, Nasdaq will determine that such
Company has met the Market Value of Unrestricted Publicly Held Shares
requirement if the Company satisfies the applicable Market Value of
Unrestricted Publicly Held Shares requirement and provides a Valuation
evidencing a Market Value of Publicly Held Shares of at least
$250,000,000.
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    \12\ IM-5315-1 describes the requirement for a Valuation,
including the experience and independence of the entity providing
the Valuation.
    \13\ Nasdaq defines ``Private Placement Market'' in Listing Rule
5005(a)(34) as a trading system for unregistered securities operated
by a national securities exchange or a registered broker-dealer.
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    In contrast, when applying this requirement to a Direct Listing
with a Capital Raise, the Exchange and investors know the minimum price
at which the company can sell shares in the offering because it is
included in the company's registration statement, and therefore Nasdaq
is proposing the following:
     Nasdaq will calculate the value of shares, including those
being sold by the company and those held by public shareholders
immediately prior to the listing, using a price per share equal to the
lowest price in the price range disclosed by the issuer in its
registration statement.\14\ Nasdaq also will determine whether the
company has met the applicable bid price and market capitalization
requirements based on the same per share price.
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    \14\ As described below, the Nasdaq Halt Cross would not execute
at a price that is below the bottom of the disclosed range. Thus,
this is the minimum price at which the company could list in
connection with a Direct Listing with a Capital Raise.
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     In determining whether the company satisfies the Market
Value of Unrestricted Publicly Held Shares for initial listing on the
Nasdaq Global Select Market, the Exchange will deem such Company to
have met the applicable requirement if the amount of the Company's
Unrestricted Publicly Held Shares before the offering, along with the
market value of the shares to be sold by the company in the Direct
Listing with a Capital Raise is at least $110 million (or $100 million,
if the Company has stockholders' equity of at least $110 million).\15\
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    \15\ See Listing Rules 5315(f)(2)(A) and (B) that require the
Market Value of Unrestricted Publicly Held Shares for initial
listing on the Nasdaq Global Select Market, not in connection with
an IPO, of at least $110 million; or at least $100 million, if the
company has stockholders' equity of at least $110 million,
respectively. For example, if the company is selling five million
shares in the opening auction and there are 45 million shares issued
and outstanding immediately prior to the listing that are eligible
for inclusion as unrestricted publicly-held shares based on
disclosure in the company's registration statement, then the Market
Value of Unrestricted Publicly Held Shares will be calculated based
on a combined total of 50 million shares. If the lowest price of the
price range disclosed in the company's registration statement is $10
per share, the Exchange will attribute to the company a Market Value
of Unrestricted Publicly Held Shares of $500 million, based on a $10
price per share.
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    Officers, directors or owners of more than 10% of the company's
common stock prior to the opening auction may purchase shares sold by
the company in the opening auction, provided that such purchases are
not inconsistent with general anti-manipulation provisions, Regulation
M, and other applicable securities laws. In addition, in the same way
as for shares of a company listing following a traditional underwritten
IPO, such an insider owner may purchase shares sold by other
shareholders or sell its own shares in the opening auction and in
trading after the opening auction, to the extent not inconsistent with
general anti-manipulation provisions, Regulation M, and other
applicable securities laws. Shares held by these types of inside
investors are not included in calculations of Publicly Held Shares for
purposes of Exchange listing rules except that, as proposed with
respect to a Direct Listing with a Capital Raise, all shares sold by
the company in the offering and all shares held by Public Holders prior
to the offering will be included in the calculation of Publicly Held
Shares, even if some of these shares are purchased by inside
investors.\16\ The Exchange notes that such investors may also acquire
in secondary market trades shares sold by the issuer in a Direct
Listing with a Capital Raise that were included when calculating
whether the issuer meets the Market Value of Unrestricted Publicly Held
Shares requirement for initial listing. However, the Exchange notes
that a company listing in conjunction with a Direct Listing with a
Capital Raise will be required to have a Market Value of Unrestricted
Publicly Held Shares much higher than the Exchange's minimum $45
million Market Value of Unrestricted Publicly Held Shares requirement
for a traditional underwritten IPO.\17\ This heightened requirement,
along with the ability of all investors to purchase shares in the
opening process on the Exchange, should result in companies using a
Direct Listing with a Capital Raise having adequate public float and a
liquid trading market after the completion of the opening auction.
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    \16\ Rule 5005(a)(35).
    \17\ See Listing Rules 5315(f)(2)(C) that requires the Market
Value of Unrestricted Publicly Held Shares for initial listing on
the Nasdaq Global Select Market, in connection with an IPO, of at
least $45 million.
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    Any company listing in connection with a Direct Listing with a
Capital Raise would continue to be subject to, and required to meet,
all other applicable initial listing requirements, including the
requirements to have the applicable number of shareholders and at least
1,250,000 Unrestricted Publicly Held Shares outstanding at the time of
initial listing, and the requirement to have a price per share of at
least $4.00 at the time of initial listing.\18\
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    \18\ See Listing Rules 5315(f)(1), (e)(1) and (2), respectively.
Rule 5315(f)(1) requires a security to have: (A) At least 550 total
holders and an average monthly trading volume over the prior 12
months of at least 1,100,000 shares per month; or (B) at least 2,200
total holders; or (C) a minimum of 450 round lot holders and at
least 50% of such round lot holders must each hold unrestricted
securities with a market value of at least $2,500.
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    Proposed Listing Rule IM-5315-2 also requires that securities
listing in connection with a Direct Listing with a

Capital Raise must begin trading on Nasdaq following the initial
pricing through the Nasdaq Halt Cross, which is described in Rules
4120(c)(8) and 4753. To allow such initial pricing, the company must,
in accordance with Rule 4120(c)(9), have a broker-dealer serving in the
role of financial advisor to the issuer of the securities being listed,
who is willing to perform the functions under Rule 4120(c)(8) that are
performed by an underwriter with respect to an initial public
offering.\19\ However, as described in detail below, Nasdaq proposes to
modify Rule 4120(c)(9), in part related to certain functions that are
performed by an underwriter in an IPO or a financial advisor in a
Direct Listing, to require that in the case of a Direct Listing with a
Capital Raise, Nasdaq, in consultation with the financial advisor to
the issuer, will make the determination of whether the security is
ready to trade and whether to postpone and reschedule the offering as
described in Rule 4120(c)(8)(A).
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    \19\ As noted below, the Exchange also proposes to amend Rule
4120(c)(9) to specify that any services provided by such financial
advisor to the issuer of a security, including a company listing in
connection with a Direct Listing with a Capital Raise, must provide
such services in a manner that is consistent with all federal
securities laws, including Regulation M and other anti-manipulation
requirements.
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Amendment to Rule 4702
    The Exchange proposes to amend Rule 4702 to add a new order type,
the ``Company Direct Listing Order'' or ``CDL Order'', which will be
used for the company's order in a Direct Listing with a Capital Raise.
This will be a market order entered for the quantity of shares offered
by the issuer, as disclosed in an effective registration statement for
the offering that will execute at the price determined in the Nasdaq
Halt Cross. A CDL Order may be entered only on behalf of the issuer and
the CDL Order may not be cancelled or modified. Only one Nasdaq member,
representing the issuer, may enter a CDL Order during a Direct Listing
with a Capital Raise. The price of the CDL Order will be set in
accordance with Rule 4120(c)(9)(B) that requires, among other things,
that the CDL Order is executed at or above the lowest price and at or
below the highest price of the price range established by the issuer in
its effective registration statement.
    Under Nasdaq rules, a market order, such as the CDL Order, must be
executed in full at the price determined in the Nasdaq Halt Cross. In
addition, all orders priced better than the price determined in the
Nasdaq Halt Cross also would need to be satisfied.\20\
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    \20\ The Commission did not identify any concerns with the
proposed changes to Rule 4702 in the OIP. Accordingly, no changes to
that proposed rule are proposed in this amendment. Nasdaq notes that
the proposed CDL Order is similar in some respects to a limit order
because it cannot execute at a price less than the lowest price in
the price range disclosed by the issuer in its effective
registration statement. As a market order, the CDL Order is
guaranteed to execute in the Nasdaq Halt Cross.
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Amendments to Rules 4120(c)(9), 4753(a)(3) and 4753(b)(2)
    Nasdaq proposes to amend Rules 4120(c)(9), 4753(a)(3) and
4753(b)(2) to establish requirements for disseminating information,
establishing the opening price and initiating trading through the
Nasdaq Halt Cross in a Direct Listing with a Capital Raise.
    Under the proposal, in the case of the Direct Listing with a
Capital Raise, a security shall not be released for trading by Nasdaq
unless the actual price calculated by the cross is at or above the
lowest price and at or below the highest price of the price range
established by the issuer in its effective registration statement.\21\
This requirement would be in addition to the existing conditions
described in Rule 4120(c)(8)(A)(i), (ii), and (iii), which would
continue to apply, as modified by the proposed changes to Rule
4120(c)(9), as described below.\22\
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    \21\ See Proposed Rule 4120(c)(9)(B).
    \22\ Rule 4120(c)(8)(A) provides that a security will not be
released for trading until Nasdaq receives notice from the
underwriter of the IPO or financial advisor in the case of a Direct
Listing that the security is ready to trade, the system verifies
that all market orders will be executed in the Cross, and the price
determined in the Cross satisfies a price validation test.
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    Rules 4120(c)(8) and (9) provide that the underwriter of the IPO,
or the financial advisor in a Direct Listing, respectively, provide
notice to Nasdaq that the security subject to the Nasdaq Halt Cross is
``ready to trade.'' \23\ These rules also provide that the underwriter
of the IPO, or the financial advisor in a Direct Listing, with
concurrence of Nasdaq, may determine at any point during the Halt Cross
process up through the conclusion of the pre-launch period to postpone
and reschedule the pricing of the security subject to the Nasdaq Halt
Cross.
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    \23\ Rule 4120(c)(8)(A)(i) provides that Nasdaq receives notice
from the underwriter of the IPO that the security is ready to trade.
The Nasdaq system will calculate the Current Reference Price at that
time and display it to the underwriter. If the underwriter then
approves proceeding, the Nasdaq system will conduct certain
validation checks. Under this proposal, Nasdaq will take over these
functions of the underwriter, as described in detail below.
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    However, Nasdaq proposes to require that in the case of a Direct
Listing with a Capital Raise, Nasdaq, in consultation with the
financial advisor to the issuer, will make the determination of whether
the security is ready to trade and whether to postpone and reschedule
the offering as described in Rule 4120(c)(8)(A). Specifically, Nasdaq
auction technology displays the Current Reference Price, which is the
price at which the auction can cross the largest number of securities
subject to the Nasdaq Halt Cross. If the auction cannot match all the
entered orders at the Current Reference Price, an imbalance on the buy
or sell side is displayed and provided via Nasdaq data feeds. Nasdaq
would determine that the security is ready to trade when Nasdaq
believes, based on the displayed information referenced above, that a
reasonable volume of securities will cross on the initial trade to
minimize the immediate price volatility following the initial
pricing.\24\ Nasdaq may consult with the financial advisor to the
issuer as to the reasonableness of such volume but can determine that
the security is ready to trade without such consultation. Once Nasdaq
has determined that the security is ready to trade, which will satisfy
the requirement of Rule 4120(c)(8)(A)(i), Nasdaq shall release the
security for trading if the conditions described in Rules
4120(c)(8)(A)(ii) and (iii) are met and the actual price calculated by
the Cross is at or above the lowest price and at or below the highest
price of the price range established by the issuer in its effective
registration statement.
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    \24\ Rules 4120(c)(8)(B) and (c)(9) provide that the financial
advisor selects certain price bands for purposes of applying a price
validation test that occurs once the financial advisor notifies
Nasdaq that the security is ready to trade. Given that Nasdaq
proposes that in connection with a Direct Listing with a Capital
Raise Nasdaq, rather than the financial advisor, determines that the
security is ready to trade, the financial advisor will have no
purpose in setting the bands. Accordingly, because Nasdaq determines
when the security is ready to trade, it is appropriate for Nasdaq to
set the price bands. Nasdaq intends to set the price bands at zero.
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    If there is insufficient buy interest to satisfy the CDL Order, and
all other market orders, as required by this proposed rule, or if the
actual price calculated by the Cross is outside the price range
established by the issuer in its effective registration statement, the
Cross would not proceed and such security would not begin trading. In
such event, because the Cross cannot be conducted, the Exchange would
postpone and reschedule the offering and notify market participants via
a Trader Update that the Direct Listing with a Capital Raise scheduled
for that date has been cancelled and any orders for that security that
have been entered

on the Exchange, including the CDL Order, would be cancelled back to
the entering firms.
    Because the CDL Order will be a market order, if the Halt Cross
proceeds, that order will execute in full in the Halt Cross, along with
orders priced at or better than the price determined in the Halt Cross.
As noted above, the Halt Cross would not be allowed to proceed if the
actual price calculated by the Cross is below the lowest price or above
the highest price of the price range disclosed by the company in its
effective registration statement.
    Nasdaq also proposes changes to Rules 4753(a)(3) and 4753(b)(2) to
make adjustments to the calculation of the Current Reference Price,
which is disseminated in the Nasdaq Order Imbalance Indicator, in the
case of a Direct Listing with a Capital Raise and for how the price at
which the Nasdaq Halt Cross will execute. In each case, where there are
multiple prices that would satisfy the conditions for determining a
price, Nasdaq proposes to modify the fourth tie-breaker for a Direct
Listing with a Capital Raise, to use the lowest price of the price
range disclosed by the issuer in its effective registration statement.
    In this Amendment No. 1, Nasdaq also proposes changes to address
concerns raised by the Commission in the OIP relating to Rule 4120.
Specifically, consistent with Nasdaq's original intent, as revised, the
price bands established by Rule 4120(c)(8) cannot act to cause the Halt
Cross to occur outside of the price range disclosed by the issuer in
its effective registration statement because the actual price
calculated by the Cross is required to be at or above the lowest price
and at or below the highest price of the price range established by the
issuer in its effective registration statement.\25\
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    \25\ In addition, in the OIP the Commission expressed concern
that the financial advisor could, in effect, cancel the non-
cancellable CDL Order by rescheduling the offering. To address this
concern, this amendment modifies the rules to provide that Nasdaq,
in consultation with the financial advisor to the issuer, will make
the determination of whether the security is ready to trade and
whether to postpone and reschedule the offering as described in Rule
4120(c)(8)(A). Finally, the proposed changes to Rule 4753 have been
modified to reflect that the lowest price at which the Nasdaq Halt
Cross can occur is the lowest price of the price range disclosed by
the issuer in its effective registration statement.
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    Finally, Nasdaq proposes to amend Rule 4120(c)(9) to specify that
the activities performed by a financial advisor under Rule 4120(c)(8)
must be conducted in a manner that is consistent with all federal
securities laws, including Regulation M and other anti-manipulation
requirements.\26\ This change will apply to traditional Direct
Listings, as described under IM-5315-1, IM-5405-1 and IM-5505-1, as
well as to Direct Listings with a Capital Raise, as described under
proposed IM-5315-2.
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    \26\ Rule 4120(c)(8) describes the activities performed by an
underwriter in an IPO and by a financial advisor in a Direct
Listing.
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2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\27\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\28\ in particular, in that it is designed to
promote just and equitable principles of trade, to remove impediments
to and perfect the mechanism of a free and open market and a national
market system, and, in general to protect investors and the public
interest.
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    \27\ 15 U.S.C. 78f(b).
    \28\ 15 U.S.C. 78f(b)(5).
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    Nasdaq believes that the proposed amendment to the listing
requirements is consistent with the protection of investors. The
proposal would require that a company completing a Direct Listing with
a Capital Raise have an aggregate market value of unrestricted
publicly-held shares immediately prior to listing together with the
market value of shares the company sells in the opening auction total
at least $110 million (or $100 million, if the Company has
stockholders' equity of at least $110 million), with such market value
calculated using a price per share equal to the lowest price of the
price range established by the issuer in its effective registration
statement. While officers, directors or owners of more than 10% of the
company's common stock prior to the opening auction may purchase shares
sold by the company or other shareholders in the opening transaction on
Nasdaq, in the event that such purchases are not inconsistent with
general anti-manipulation provisions, Regulation M, and other
applicable securities laws, Nasdaq expects that a company expecting to
sell a significant portion of its shares to officers, directors and
existing significant shareholders would not undertake a public listing
through a Direct Listing with a Capital Raise but would raise capital
in a private placement or a similar transaction instead. Nasdaq also
notes that a company may list on the Global Select Market in connection
with its initial public offering with a market value of unrestricted
publicly held shares of $45 million and that unlike a company listing
in connection with a Direct Listing that could qualify for the price-
based initial listing requirements based on a Valuation, a company
listing in connection with a Direct Listing with a Capital Raise, like
an IPO, must qualify for such requirements based on the minimum price
at which it could sell shares in the offering. The higher requirement,
along with the ability of all investors to purchase shares in the
opening process on the Exchange, should result in companies using a
Direct Listing with a Capital Raise having adequate public float and a
liquid trading market after the completion of the opening auction.
    Nasdaq also believes that it is consistent with the protection of
investors to calculate the security's bid price and values derived from
the security's price using a price per share equal to the lowest price
of the price range disclosed by the issuer in its effective
registration statement. Nasdaq will allow the Halt Cross to take place
as low as this price, but no lower, and so this is the minimum price at
which the company could be listed.
    The proposed requirement that a company that lists on the Nasdaq
Global Select Markets through a Direct Listing with a Capital Raise
must begin trading of the company's securities following the initial
pricing through the Halt Cross will promote fair and orderly markets by
protecting against volatility in the pricing and initial trading of
securities covered by the proposed rule change because a substantial
number of buy and sell orders is expected to be executed in the Halt
Cross at a single price rather than in the secondary trading at
fluctuating prices. Accordingly, Nasdaq believes these changes, as
required by Section 6(b)(5) of the Exchange Act, are reasonably
designed to protect investors and the public interest and promote just
and equitable principles of trade for the opening of securities listing
in connection with a Direct Listing with a Capital Raise on the Nasdaq
Global Select Market.
    Nasdaq also believes that the proposed adoption of the CDL Order
type in Rule 4702 and the addition of requirements to the operation of
the Nasdaq Halt Cross in Rule 4120(c)(9) will remove impediments to and
perfect the mechanism of a free and open market and a national market
system because it would guarantee that the Nasdaq Halt Cross would only
occur within the specified price range, as described above, and, if the
Halt Cross occurs, all shares offered by the company would be sold at
such price. Unlike an IPO, a company listing through a Direct Listing
with a Capital Raise would not have an underwriter to

guarantee that a specified number of shares would be sold by the
company at a price consistent with disclosure in the company's
effective registration statement. This certainty would be effected in
two ways. First, the proposed CDL Order would be required to be equal
to the total number of shares disclosed as being offered by the company
in the prospectus included in the effective registration statement
filed in connection with its listing. The Nasdaq Halt Cross would only
occur if all of the shares in this market order could be executed.
Second, the Nasdaq Halt Cross would be required to occur at a price per
share that is within the price range disclosed by the issuer in its
effective registration statement. Nasdaq further believes that these
proposed changes would remove impediments to and perfect the mechanism
of a free and open market and a national market system because they are
designed to function seamlessly with the existing process for the
Nasdaq Halt Cross, including dissemination of information about the
expected price.
    Nasdaq believes that the CDL Order and related clarifications will
clearly define the method by which the issuer participates in the
opening auction, to prevent the issuer from being in a position to
improperly influence the price discovery process, and to design an
auction that is otherwise consistent with the disclosures in the
registration statement. Specifically, the CDL Order entered on the
company's behalf could not be executed at a price below the low end or
above the high end of the price range in the company's effective
registration statement and, as a market order, the full quantity of
shares in the CDL Order would have to be executed in the opening
auction. In addition, the CDL Order cannot be modified and the
financial advisor to the company will be unable to reschedule the
offering once it begins. As such, Nasdaq believes that the proposed
process provides reasonable assurance that the opening auction and
subsequent trading promote fair and orderly markets and that the
proposed rules are designed to prevent manipulative acts and practices,
and protect investors and the public interest in accordance with
Section 6(b)(5) of the Exchange Act.
    Nasdaq believes that it is consistent with the protection of
investors and the public interest to require that in the case of a
Direct Listing with a Capital Raise, Nasdaq, in consultation with the
financial advisor to the issuer, will make the determination of whether
the security is ready to trade and whether to postpone and reschedule
the offering as described in Rule 4120(c)(8)(A) because Nasdaq would
determine that the security is ready to trade when Nasdaq believes,
based on the available information, that a reasonable volume of
securities will cross on the initial trade to minimize the immediate
price volatility following the initial pricing. Nasdaq also believes
that its ability to consult the financial advisor to the issuer is
consistent with the protection of investors because the financial
advisor would be expected to gather relevant information in connection
with the Direct Listing with a Capital Raise by engaging in certain
price discovery activities with potential buyers and sellers and such
information could be shared with Nasdaq. Nasdaq believes that as part
of their regular activities as full-service broker-dealer, such firm's
capital markets and sales and trading desk personnel may contact or be
contacted by potential investors and current holders of the securities
subject to the Nasdaq Halt Cross in the normal course of their
activities and may, in that capacity, inform and educate interested
persons regarding the company and obtain information regarding pre-
listing buying and selling interest in such securities (including with
regard to price, volume and timing expectations), which information may
also be provided to Nasdaq in order to support an effective price
discovery process by Nasdaq.
    Nasdaq notes that, as described above, Nasdaq will be able to
postpone and reschedule the offering only if there is insufficient buy
interest to satisfy the CDL Order, and all other market orders, as
required by this proposed rule, or if the actual price calculated by
the Cross is outside the price range established by the issuer in its
effective registration statement.
    Nasdaq also believes that it is consistent with the protection of
investors and the public interest to remind financial advisors in a
Direct Listing, including Direct Listings with a Capital Raise, that
activities in connection with the listing must be conducted in a manner
that is consistent with the federal securities laws, including
Regulation M and other anti-manipulation requirements.
    Nasdaq believes that the proposed rule change to modify the fourth
tie-breaker used in calculating the Current Reference Price
disseminated in the Nasdaq Order Imbalance Indicator and the price at
which the Nasdaq Halt Cross will occur, protects investors and the
public interest. For a Direct Listing, in using the Halt Cross to
initiate the initial trading in the company's securities, the Current
Reference Price and price at which the Nasdaq Halt Cross will occur may
be based on the most recent transaction price in a Private Placement
Market where the security has had recent sustained trading in such a
market over several months; otherwise the price will be determined by
the Exchange in consultation with a financial advisor to the issuer.
For an IPO, however, the fourth tie-breaker used in calculating the
Current Reference Price, is the price that is closest to the Issuer's
Initial Public Offering Price. Because a Direct Listing with a Capital
Raise is similar to an IPO in that the company sells securities in the
offering, the proposed rule change provides that the forth tie-breaker
in calculating the Current Reference Price for such security is the
lowest price of the price range disclosed by the issuer in its
effective registration statement, which is the minimum price at which
the Halt Cross will occur.
    Finally, while a commenter expressed concerns that that the
expansion of direct listings would compound problems that shareholders
face in tracing their share purchases to a registration statement,\29\
the Commission has previously considered and rejected these
concerns.\30\ In that regard, the Commission has determined that
investor protection concerns relating to tracing challenges are not
unique to direct listings, including where the company itself would
sell shares in the opening auction on the first day of trading on the
Exchange in addition to, or instead of, facilitating sales by selling
shareholders (``Primary Direct Floor Listing''), and stated that it did
not expect ``any such tracing challenges in this context to be of such
magnitude as to render the proposal inconsistent with the Act.'' \31\
On the other hand, the Commission found that allowing a Primary Direct
Floor Listing ``will provide benefits to existing and potential
investors relative to firm

commitment underwritten offerings'' \32\ because the structure ``has
the potential to broaden the scope of investors that are able to
purchase securities in an initial public offering, at the initial
public offering price, rather than in aftermarket trading'' and ``may
allow for efficiencies in IPO pricing and allocation.'' \33\ Similarly,
while the commenter expressed concern that that the expansion of direct
listings may lead to a decline in effective governance at U.S. public
companies, presumably because of the lack of an underwriter in the
offering, Nasdaq believes that this concern is unsubstantiated and
challenges in this context are not of such magnitude as to render the
proposal inconsistent with the Act. Moreover, in approving the Primary
Direct Floor Listing proposal the Commission concluded that it ``does
not view a firm commitment underwriting as necessary to provide
adequate investor protection in the context of a registered offering.''
\34\ As a result, consistent with the purposes of the Act, the proposed
rule change may provide investors with additional investment
opportunities and companies with more options for becoming publicly
traded.
---------------------------------------------------------------------------

    \29\ See Letter from Jeffrey P. Mahoney, General Counsel,
Council of Institutional Investors to Secretary, Securities and
Exchange Commission (October 8, 2020), available at https://www.sec.gov/comments/sr-nasdaq-2020-057/srnasdaq2020057-7888884-224228.pdf. See also Letter from Jeffrey P. Mahoney, General
Counsel, Council of Institutional Investors to Secretary, Securities
and Exchange Commission (January 13, 2021), available at https://www.sec.gov/comments/sr-nasdaq-2020-057/srnasdaq2020057-8241868-227781.pdf.
    \30\ Securities Exchange Act Release No. 89684 (August 26,
2020), 85 FR 54454 (September 1, 2020) (approval by delegated
authority of SR-NYSE-2019-67). On December 22, 2020, the Commission
issued an order setting aside the action by delegated authority and
approving the proposed rule change. Securities Exchange Act Release
No. 90768 (December 22, 2020), 85 FR 85807 (December 29, 2020) (the
``NYSE Approval'').
    \31\ NYSE Approval at 85816.
    \32\ Id.
    \33\ Id.
    \34\ Id. at 85815.
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. The proposed amendments would
not impose any burden on competition, but would rather increase
competition. In that regard, the Commission recently approved a similar
proposal to allow a Primary Direct Floor Listing on the New York Stock
Exchange.\35\ Allowing Nasdaq to have similar rules will give issuers
interested in this pathway to access the capital markets a choice of
listing venues, which will enhance competition among exchanges.
---------------------------------------------------------------------------

    \35\ See NYSE Approval, above footnote 30.
---------------------------------------------------------------------------

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

    No written comments were either solicited or received.

III. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change, as modified by Amendment No. 1, is consistent with the Act.
Comments may be submitted by any of the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2020-057 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2020-057. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of such filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-NASDAQ-2020-057, and should be submitted
on or before March 23, 2021 .

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\36\
---------------------------------------------------------------------------

    \36\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-04222 Filed 3-1-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 97 (Friday, May 18, 2012)]
[Notices]
[Pages 29630-29631]
[FR Doc No: 2012-12068]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13843-001]

Qualified Hydro 24, LLC; Notice of Scoping Meetings and
Environmental Site Review and Soliciting Scoping Comments

    a. Type of Filing: Notice of Intent to file license application and
pre-application document.
    b. Project No.: 13843-001.
    c. Date filed: January 3, 2012.
    d. Applicant: Qualified Hydro 24, LLC.

    e. Name of Project: Cle Elum Project.
    f. Location: On the Cle Elum River, in Kittitas County, Washington.
A portion of the project occupies United States lands administered by
U.S. Forest Service.
    g. Filed Pursuant to: 18 CFR 5.5 and 5.6 of the Commission's
regulations.
    h. Potential Applicant Contact: Ramya Swaminathan, Qualified Hydro
24, LLC, 239 Causeway Street, Suite 300, Boston, MA 02114; (978) 283-
2822.
    i. FERC Contact: Jim Hastreiter at<PHONE_NUMBER>; or email at
<EMAIL_ADDRESS>    j. Deadline for filing information, study requests, and scoping
comments: July 13, 2012.
    All documents may be filed electronically via the Internet. See 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site 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>or toll free at 1-866-208-3676,
or for TTY,<PHONE_NUMBER>. Although the Commission strongly encourages
electronic filing, documents may also be paper-filed. To paper-file,
mail an original and seven copies to: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426.
    k. The proposed project would use the existing dam, intake
structure, discharge conduit, and outlet conduit to generate power by
using flow releases from Reclamation's existing Cle Elum Dam. The
proposed project would consist of following new structures: (1) A 25-
foot-long, steel lined bifurcation; (2) a steel 100-foot-long, 12-foot-
diameter penstock; (3) a steel 50-foot-diameter, 140-foot-tall surge
tank; (4) a 50- by 80-foot concrete powerhouse with associated control
equipment; (5) two vertical Francis turbines and two 3.7 MW generators;
(6) a 70- by 160-foot-long concrete tailrace; a 35- by 40-foot
substation; a 1,000-foot-long, 12.5 kilovolt transmission line; a 1000-
foot-long access road; and appurtenant facilities.
    l. A copy of the NOI and PAD is available for review at the
Commission in the Public Reference Room or may be viewed on the
Commission's Web site at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. For assistance, contact
FERC Online Support. A copy is also available for inspection and
reproduction at the address in item h above.
    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
m. Scoping Process
    The Commission intends to prepare an Environmental assessment (EA)
on the project in accordance with the National Environmental Policy
Act. The EA will consider both site-specific and cumulative
environmental impacts and reasonable alternatives to the proposed
action.

Scoping Meetings

    FERC staff will conduct one agency scoping meeting and one public
meeting. The agency scoping meeting will focus on resource agency and
non-governmental organization (NGO) concerns, while the public scoping
meeting is primarily for public input. All interested individuals,
organizations, and agencies are invited to attend one or both of the
meetings, and to assist the staff in identifying the scope of the
environmental issues that should be analyzed in the EA. The times and
locations of these meetings are as follows:

Agency Scoping Meeting

Date: Wednesday, June 13, 2012
Time: 2:00 p.m.
Place: Suncadia Lodge
Address: 3600 Suncadia Trail, Cle Elum, Washington 98922

Public Scoping Meeting

Date: Wednesday, June 13, 2012
Time: 7:00 p.m..
Place: Suncadia Lodge
Address: 3600 Suncadia Trail, Cle Elum, Washington 98922

    Copies of the Scoping Document (SD1) outlining the subject areas to
be addressed in the EIS were distributed to the parties on the
Commission's mailing list. Copies of the SD1 will be available at the
scoping meeting or may be viewed on the Web at http://www.ferc.gov
using the ``eLibrary'' link (see item l above).

Environmental Site Review

    The Applicant, Bureau of Reclamation, and FERC staff will conduct a
project Environmental Site Review beginning at 9:00 a.m. on June 13,
2012. All interested individuals, organizations, and agencies are
invited to attend. All participants should meet at the Cle Elum dam.
All participants are responsible for their own transportation to the
site. Anyone with questions about the Environmental Site Review should
contact Mr. Alan Topalian of Qualified Hydro 24, LLC at<PHONE_NUMBER>,
ext. 122.

Objectives

    At the scoping meetings, the staff will: (1) Summarize the
environmental issues tentatively identified for analysis in the EA; (2)
solicit from the meeting participants all available information,
especially quantifiable data, on the resources at issue; (3) encourage
statements from experts and the public on issues that should be
analyzed in the EA, including viewpoints in opposition to, or in
support of, the staff's preliminary views; (4) determine the resource
issues to be addressed in the EA; and (5) identify those issues that
require a detailed analysis, as well as those issues that do not
require a detailed analysis.

Procedures

    The meetings are recorded by a stenographer and become part of the
formal record of the Commission proceeding on the project.
    Individuals, organizations, and agencies with environmental
expertise and concerns are encouraged to attend the meeting and to
assist the staff in defining and clarifying the issues to be addressed
in the EA.

    Dated: May 14, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-12068 Filed 5-17-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 90 (Thursday, May 11, 2017)]
[Notices]
[Page 21990]
[FR Doc No: 2017-09591]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[EPA-R07-OW-2017-0097; FRL-9960-75-Region 7]

Notice of Approval of Underground Injection Control Program;
Occidental Chemical Corporation, Wichita, Kansas

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of approval of modification of existing no migration
petition.

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

SUMMARY: Environmental Protection Agency (EPA) is hereby giving notice
of approval of the modification of an existing no migration petition
(petition) by Occidental Chemical Corporation (Occidental) under the
1984 Hazardous and Solid Waste Amendments to the Resource Conservation
and Recovery Act.

DATES: This action is effective June 12, 2017.

ADDRESSES: Copies of the petition and all pertinent information
relating thereto are on file at Environmental Protection Agency, Region
7, Regional Records Center, 11201 Renner Boulevard, Lenexa, Kansas
66219.

FOR FURTHER INFORMATION CONTACT: Mary Tietjen Mindrup, Chief, Drinking
Water Management Branch, EPA Region 7, 11201 Renner Boulevard, Lenexa,
Kansas 66219, telephone<PHONE_NUMBER>, or email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA is hereby giving notice of approval of
the modification of an existing no migration petition (petition) for
exemption from hazardous waste disposal restrictions of the Resource
Conservation and Recovery Act Class I Hazardous Waste Injection for
Occidental Chemical Corporation (Occidental) under the 1984 Hazardous
and Solid Waste Amendments Occidental has adequately demonstrated to
the satisfaction of EPA by the petition modification application and
supporting documentation that, to a reasonable degree of certainty,
there will be no migration of hazardous constituents from the injection
zone for as long as the waste remains hazardous.
    The existing petition allows for the subsurface disposal by
Occidental of specific restricted wastes via Class I injection wells at
Occidental's Wichita, Kansas facility and was approved by EPA with an
effective date of October 24, 2008. In its modification application,
Occidental requested that the existing petition include Well Number 11,
a new well, as a replacement for Well Number 4, which was permanently
plugged in 2008. This action results in no change to the volume of
fluids to be injected.
    This final decision allows the underground injection by Occidental
of the specific restricted wastes identified in the modified petition
into injection well Number 11 at the Wichita, Kansas facility until
December 31, 2020, unless EPA moves to terminate this exemption.
Included in this approval is the stipulation that Occidental acquires
and continues to maintain an approved permit from the Kansas Department
of Health and Environment.
    A public notice concerning the Agency's proposed action was issued
on December 12, 2016, and the public comment period closed on January
25, 2017. In addition to soliciting written comments regarding the
Agency's proposed approval, EPA conducted a public availability session
and a formal public hearing on January 11, 2017, at the Haysville
Learning Center in Haysville, Kansas. No comments were received during
the comment period. This decision constitutes a final Agency action.
There is no further administrative process to appeal this decision.

    Dated: March 20, 2017.
Edward H. Chu,
Acting Regional Administrator, Region 7.
[FR Doc. 2017-09591 Filed 5-10-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 5 (Friday, January 7, 2011)]
[Notices]
[Pages 1181-1182]
[FR Doc No: 2011-32]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]

Oncologic Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Oncologic Drugs Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on February 8, 2011, from 8
a.m. to 5 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building
31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD
20993-0002. Information regarding special accommodations due to a
disability, visitor parking and transportation may be accessed at:
http://www.fda.gov/AdvisoryCommittees/default.htm; under the heading
``Resources for You'', click on ``White Oak Conference Center Parking
and Transportation Information for FDA Advisory Committee Meetings''.
Please note that visitors to the White Oak Campus must enter through
Building 1.
    Contact Person: Nicole Vesely, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, rm. 2417, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, FAX: 301-847-
8532, email<EMAIL_ADDRESS>or FDA

Advisory Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in
the Washington, DC area), and follow the prompts to the desired center
or product area. Please call the Information Line for up-to-date
information on this meeting. A notice in the Federal Register about
last minute modifications that impact a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check the Agency's Web site
and call the appropriate advisory committee hot line/phone line to
learn about possible modifications before coming to the meeting.
    Agenda: The committee will hear updates on new drug applications
(NDAs) and biologics license applications (BLAs) approved under 21 CFR
314.500 and 601.40 (subpart H and subpart E, respectively, accelerated
approval regulations) prior to January 1, 2009. These updates will
provide information related to the status of phase IV clinical studies
and to difficulties associated with completion of phase IV commitments.
Phase IV studies are postmarketing studies to confirm clinical benefit
of a drug after it receives accelerated approval.
    Specifically, the committee will receive updates on the following
products: (1) BLA 125084, trade name ERBITUX (cetuximab), application
submitted by Imclone Systems Inc., used in combination with the
anticancer agent irinotecan and indicated for the treatment of
epidermal growth factor receptor (EGFR)-expressing colorectal cancer
that has metastasized (spread beyond the colon or rectum) in patients
for whom chemotherapy using irinotecan alone is ineffective or less
effective; (2) supplemental BLA (sBLA) 125011/24, trade name BEXXAR
(tositumomab and Iodine I 131 tositumomab), application submitted by
SmithKline Beecham Corp. doing business as (d/b/a) GlaxoSmithKline,
indicated for the treatment of patients with varieties of non-Hodgkin's
lymphoma known as CD20 antigen-expressing relapsed or refractory, low
grade, follicular, or transformed non-Hodgkin's lymphoma, who have not
received the drug Rituximab; (3) NDA 21-673, tradename CLOLAR
(clofarabine) for intravenous infusion, application submitted by
Genzyme Corp., indicated for the treatment of pediatric patients 1 to
21 years old with acute lymphoblastic leukemia (ALL) whose disease has
not responded to or has relapsed following treatment with at least two
prior chemotherapy regimens; (4) NDA 21-877, tradename ARRANON
(nelarabine) Injection, application submitted by GlaxoSmithKline,
indicated for the treatment of patients with types of leukemia or
lymphoma known as T-cell acute lymphoblastic leukemia and T-cell
lymphoblastic lymphoma whose disease has not responded to or has
relapsed following treatment with at least two chemotherapy regimens;
(5) BLA 125147, tradename VECTIBIX (panitumumab), application submitted
by Amgen Inc., indicated for the treatment of EGFR-expressing,
metastatic colorectal carcinoma with disease progression on or
following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing
chemotherapy regimens; and (6) sNDA 21-588/025, tradename GLEEVEC
(imatinib mesylate) tablets, application submitted by Novartis
Pharmaceuticals Corp., indicated for the adjuvant (additional)
treatment of adult patients following complete gross resection
(removal) of a form of cancer known as Kit (CD117) positive
gastrointestinal stromal tumors (GIST).
    Based on the updates provided, the committee will have a general
discussion centering on possible ways to improve the planning and
conduct of trials to confirm clinical benefit (post marketing
requirements). The overall goal will be the optimization of the
accelerated approval process with a focus on decreasing the amount of
time to confirm (or fail to confirm) clinical benefit while continuing
to provide early availability of promising oncology products.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
January 25, 2011. Oral presentations from the public will be scheduled
between approximately 1:30 p.m. and 2:30 p.m. Those individuals
interested in making formal oral presentations should notify the
contact person and submit a brief statement of the general nature of
the evidence or arguments they wish to present, the names and addresses
of proposed participants, and an indication of the approximate time
requested to make their presentation on or before January 14, 2011.
Time allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by January 18, 2011.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Nicole Vesely at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: January 3, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-32 Filed 1-6-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 79, Number 219 (Thursday, November 13, 2014)]
[Notices]
[Page 67535]
[FR Doc No: 2014-26879]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2014-119]

Petition for Exemption; Summary of Petition Received

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of petition for exemption received.

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SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of 14 CFR. The purpose of this notice is to
improve the public's awareness of, and participation in, this aspect of
FAA's regulatory activities. Neither publication of this notice nor the
inclusion or omission of information in the summary is intended to
affect the legal status of the petition or its final disposition.

DATES: Comments on this petition must identify the petition docket
number and must be received on or before December 3, 2014.

ADDRESSES: You may send comments identified by Docket Number FAA-2014-
0845 using any of the following methods:
     Government-wide rulemaking Web site: Go to http://www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Send comments to the Docket Management Facility;
U.S. Department of Transportation, 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590.
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    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on November 6, 2014.
James M. Crotty,
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Petition for Exemption

    Docket No.: FAA-2014-0845.
    Petitioner: Perfect View Aerial Media, LLC.
    Section of 14 CFR Affected: Part 21, Subpart H, part 27, 45.23(b),
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training and maintenance purposes in a sterile area free from hazards
and persons, by using an unmanned aircraft system, the DJI S-1000.

[FR Doc. 2014-26879 Filed 11-12-14; 8:45 am]
BILLING CODE 4910-13-P


Imazaquin Dietary Exposure Assessment DP Barcode: D302943 PC Code: 128848 Page 1 of 13 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES MEMORANDUM DATE: 10/ 20/ 2005 SUBJECT: Imazaquin Chronic Dietary Exposure Assessment for the Tolerance Reassessment Eligibility Decision ( TRED)

PC Code: 128848 DP Barcode: D302943 REVIEWER: Susan Stanton, Environmental Scientist Reregistration Branch III/ Health Effects Division ( 7509C)

THROUGH: Christina Swartz, Chief, RAB2 Thurston Morton, Chemist Dietary Exposure Science Advisory Council ( DESAC) Health Effects Division ( 7509C)

and William Donovan, Branch Senior Scientist Branch/ Health Effects Division ( 7509C)

TO: Craig Doty, Chemical Review Manager Special Review Branch/ Special Review and Reregistration Division ( 7508C)

Executive Summary A chronic dietary risk assessment was conducted for the herbicide, imazaquin, using the Dietary Exposure Evaluation Model ( DEEM FCID, Version 2.03), which uses food consumption data from the USDA's Continuing Surveys of Food Intakes by Individuals ( CSFII) from 1994 1996 and 1998. The analysis was performed to support the imazaquin Tolerance Reassessment Eligibility Decision ( TRED). Imazaquin Dietary Exposure Assessment DP Barcode: D302943 PC Code: 128848 Page 2 of 13 No toxic effects attributable to a single ( i. e., acute) exposure have been identified; therefore, an acute Reference Dose ( RfD) has not been established for imazaquin and an acute dietary exposure assessment has not been conducted. Also, since there is no evidence that imazaquin is carcinogenic to humans, a dietary cancer assessment was not conducted.

Chronic Dietary Exposure Results and Characterization Imazaquin is registered for a single food use on soybeans. The tier 1 chronic assessment assumed that 100% of the soybean crop is treated and that residues of imazaquin are present at the tolerance level of 0.05 ppm in all soybean commodities, including processed commodities. Drinking water was incorporated directly into the dietary assessment using the tier 1 estimated drinking water concentration ( EDWC) for ground water generated by the SCI GROW model.

The resulting dietary exposure estimates are well below HED's level of concern ( i. e., < 100% of the cPAD) for the overall U. S. population and all population subgroups. Using the DEEM FCID software, dietary exposure is estimated at 0.000677 mg/ kg/ day for the U. S. population ( 0.3% of the cPAD) and 0.002208 mg/ kg/ day ( 0.9% of the cPAD) for infants less than 1 year old, the population subgroup with the highest estimated chronic dietary exposure to imazaquin.

More than 95% of the total estimated dietary exposure is from drinking water.

I. Introduction Dietary risk assessment incorporates both exposure and toxicity of a given pesticide. For chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose ( i. e., the dose which HED has concluded will result in no unreasonable adverse health effects). This dose is referred to as the chronic population adjusted dose ( cPAD). The cPAD is equivalent to the Reference Dose ( RfD) divided by the special FQPA Safety Factor.

For chronic exposures, HED is concerned when estimated dietary risk exceeds 100% of the cPAD. References which discuss the chronic risk assessment in more detail are available on the EPA/ pesticides web site: " Available Information on Assessing Exposure from Pesticides, A User's Guide," 6/ 21/ 2000, web link: http:// www. epa. gov/ fedrgstr/ EPA PEST/ 2000/ July/ Day 12/ 6061. pdf ; or see SOP 99.6 ( 8/ 20/ 99).

The only previous dietary assessment for imazaquin that is available in HED's records is an assessment ( dated 3/ 9/ 94) without an accompanying memorandum which was done using the Dietary Risk Evaluation System ( DRES) model. This assessment estimated chronic exposure and risk from tolerance level residues of 0.05 ppm in/ on soybean commodities, and was based on an Imazaquin Dietary Exposure Assessment DP Barcode: D302943 PC Code: 128848 Page 3 of 13 RfD of 0.25 mg/ kg/ day ( same as in the current assessment). Estimated exposures for the U. S. population and all population subgroups were less than 0.01% of the RfD.

II. Residue Information Residues of Concern: The imazaquin review team has determined that for tolerance enforcement and risk assessment purposes, the residues of concern in plants, livestock and drinking water are as follows:

Plants: The nature of the residue in plants is adequately understood for the use of imazaquin on soybeans. Based on the trace levels of radioactivity found in the soybean seed from an exaggerated application rate, the apparent extensive degradation of imazaquin into plant constituents, and the livestock grazing/ feeding prohibition of forage, straw and hay on current labels, the residue of concern for the use of imazaquin on soybeans is imazaquin, per se. There are no other food uses of imazaquin.

Livestock: Tolerances for imazaquin residues in livestock commodities are not required as a result of the use on soybeans. This determination is based on the absence of detectable residues in eggs, milk, and livestock tissues from the available animal metabolism studies and the absence of detectable residues in the submitted magnitude of residue studies for livestock feedstuffs. Additionally, label restrictions prohibit the grazing or feeding of soybean forage, hay or straw to livestock. Residue data have not been submitted for the animal feedstuff, aspirated grain fractions; however, they are not required since imazaquin is applied early in the growing season ( before the reproduction stage begins) and detectable residues are not expected in the seed. If additional uses or additional field studies result in detectable residues in feedstuffs, then additional animal metabolism studies may be required. The residue of concern in livestock commodities will be determined if/ when tolerances for secondary residues in livestock commodities are deemed necessary.

Drinking Water: Aqueous photolysis is the only significant degradation pathway for imazaquin and leads to four major degradates of greater than 10% of the applied amount ( 3 quinolinecarboxylic acid; 2,3 quinolinedicarboxylic acid imide; 2,3 dihydro 3 imino 1H pyrrolo[ 3,4 b] quinoline 1 one; and 2,3 quinolinedicarboxylic acid). These degradates are expected to form in surface water only. They are not expected to form in groundwater, since the parent compound is not exposed to light and aqueous photolysis does not occur.

HED has determined that the surface water degradates of imazaquin have the potential to be toxicologically equivalent to the parent compound; therefore, the residues of concern for risk assessment purposes in surface water include imazaquin, 3 quinolinecarboxylic acid; 2,3 Imazaquin Dietary Exposure Assessment DP Barcode: D302943 PC Code: 128848 Page 4 of 13 quinolinedicarboxylic acid imide; 2,3 dihydro 3 imino 1H pyrrolo[ 3,4 b] quinoline 1 one; and 2,3 quinolinedicarboxylic acid. The residues of concern in ground water include parent imazaquin only.

Tolerances: A tolerance of 0.05 ppm has been established under 40 CFR § 180.426 for residues of imazaquin, 2[ 4,5 dihydro 4 methyl 4( 1 methylethyl) 5 oxo 1Himidazol 2 yl] 3 quinoline carboxylic acid, in or on soybeans. HED has reassessed the tolerance and determined that it should be maintained at its current level. Residues in livestock commodities may be classified under 40 CFR § 180.6( a)( 3); i. e., no expectation of finite residues. Thus, tolerances for livestock commodities are not needed at this time.

Residue Data used for the Chronic Assessment:

Food: The tier 1 chronic assessment assumed that 100% of the soybean crop is treated and that residues of imazaquin are present at the tolerance level of 0.05 ppm in all soybean commodities, including processed commodities.

Drinking Water: Reference: Drinking Water Assessment for Imazaquin and its Salts; K. Moore; June 21, 2005, as amended on September 27, 2005.

Potential concentrations of imazaquin and its monoammonium and monosodium salts in drinking water were assessed by the Environmental Fate and Effects Division ( EFED) through an evaluation of surface water and groundwater monitoring data and modeling. Because all three compounds dissociate in water to form the carboxylate anion, they were treated concurrently in the assessment.

Imazaquin's primary use is as a broad spectrum herbicide on soybeans. The turf and ornamental use patterns were also considered in EFED's assessment. Surface and groundwater monitoring data were available from the United States Geological Survey ( USGS) National Water Quality Assessment ( NAWQA) Program and from an additional USGS study on pesticide concentrations in high use areas in the Midwest. Maximum concentrations of imazaquin in the monitoring data reviewed were 4.89 : g ae/ L in surface water and 0.098 : g ae/ L in groundwater. Because the monitoring studies reviewed are short term or not targeted to detect imazaquin, they are not likely to capture peak concentrations. Modeling was used, therefore, to predict the most conservative concentrations, with monitoring data used to confirm that modeling results are reasonable. EECs in surface water were modeled using PRZM 3.12/ EXAMS 2.98.04, and ground water concentrations were modeled using SCIGROW ( version 2.3).

At the time of EFED's original assessment, no degradates of concern had been identified and only the parent compounds ( imazaquin and its monoammonium and sodium salts) were assessed. Imazaquin Dietary Exposure Assessment DP Barcode: D302943 PC Code: 128848 Page 5 of 13 HED subsequently determined that the major surface water degradates should also be considered in the risk assessment ( See above). Therefore, EFED repeated the surface water modeling for the most vulnerable scenario, turf, with an updated photolysis half life that incorporated these degradates. The updated, total residue half life was calculated by performing first order linear regression on the log transformed sum total of imazaquin plus each of the four major degradates at each sampling point. The surface and ground water modeling results are presented in Table 1. Note that all concentrations reported in this assessment are in acid equivalents ( ae) unless otherwise specified.

Table 1. Imazaquin EECs 1 Surface water ( PRZM / EXAMS) Groundwater ( SCIGROW)

Acute ( Peak) Chronic ( Annual average) Acute & Chronic Soybeans 1.8 µ g ae/ L 0.4 µ g ae/ L 3.8 µ g ae/ L Ornamental 1.9 µ g ae/ L 1.0 µ g ae/ L 15.6 µ g ae/ L Turf  1 app. 15.2 µ g ae/ L 5.0 µ g ae/ L 15.6 µ g ae/ L Turf  1 app. 2 16.0 µ g ae/ L 6.7 µ g ae/ L 15.6 µ g ae/ L Turf  2 app. 20.0 µ g ae/ L 7.6 µ g ae/ L 31.1 µ g ae/ L Turf  2 app. 2 21.8 µ g ae/ L 11.6 µ g ae/ L 31.1 µ g ae/ L 1 All EECs are for parent compound only, unless otherwise specified. 2 The surface water EECs include parent imazaquin and its major degradates. The ground water EECs include parent compound only.

The highest imazaquin concentration was estimated for groundwater, based on 2 applications to turf at 0.5 lbs. ae/ acre. This value ( 31.1 ppb/ 0.031 ppm) was used as a point estimate to assess exposure to imazaquin from drinking water in the dietary assessment.

III. DEEM FCID   Program and Consumption Information A chronic dietary exposure assessment for imazaquin was conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database ( DEEM FCID   , Version 2.03), which incorporates consumption data from USDA's Continuing Surveys of Food Intakes by Individuals ( CSFII), 1994 1996 and 1998. The 1994 96/ 98 data are based on the reported consumption of more than 20,000 individuals over two non consecutive survey days. Foods " as consumed" ( e. g., apple pie) are linked to EPA defined food commodities ( e. g. apples, peeled fruit  cooked; fresh or N/ S; baked; or wheat flour  cooked; fresh or N/ S, baked) using publicly available recipe translation files developed jointly by USDA/ ARS and EPA. For chronic exposure assessment, consumption data are averaged for the entire U. S. population and within population Imazaquin Dietary Exposure Assessment DP Barcode: D302943 PC Code: 128848 Page 6 of 13 subgroups. Based on analysis of the 1994 96, 98 CSFII consumption data, which took into account dietary patterns and survey respondents, HED concluded that it is most appropriate to report risk for the following population subgroups: the general U. S. population, all infants (< 1 year old), children 1 2, children 3 5, children 6 12, youth 13 19, adults 20 49, females 13 49, and adults 50+ years old.

For chronic dietary exposure assessment, an estimate of the residue level in each food or foodform ( e. g., orange or orange juice) on the food commodity residue list is multiplied by the average daily consumption estimate for that food/ food form. The resulting residue consumption estimate for each food/ food form is summed with the residue consumption estimates for all other food/ food forms on the commodity residue list to arrive at the total average estimated exposure. Exposure is expressed in mg/ kg body weight/ day and as a percent of the cPAD. This procedure is performed for each population subgroup.

IV. Toxicological Information Imazaquin has relatively low toxicity, with a chronic RfD ( and cPAD) of 0.25 mg/ kg/ day. The RfD is based on the NOAEL of 25 mg/ kg from a chronic toxicity feeding study in the dog and a 100 fold inter/ intra species uncertainty factor. The FQPA safety factor has been reduced to 1x, based on the lack of evidence of pre and/ or postnatal susceptibility resulting following exposure to imazaquin and considering the lack of residual uncertainties for pre and/ or postnatal toxicity.

An endpoint of concern attributable to a single dose was not identified for imazaquin; therefore, an acute RfD was not established and an acute dietary assessment was not conducted. In addition, no evidence of carcinogenicity was seen in studies in mice or rats. Therefore, a cancer dietary exposure assessment was not conducted.

Table 2. Summary of Toxicological Doses and Endpoints for Imazaquin for Use in Dietary Exposure Assessment Exposure Scenario Dose Used in Risk Assessment, UF Hazard and Exposure Based Special FQPA Safety Factor Study and Toxicological Effects Acute Dietary ( females 13 49) None selected. No evidence of relevant toxicity following a single dose.

Acute Dietary ( general population) Imazaquin Dietary Exposure Assessment DP Barcode: D302943 PC Code: 128848 Table 2. Summary of Toxicological Doses and Endpoints for Imazaquin for Use in Dietary Exposure Assessment Exposure Scenario Dose Used in Risk Assessment, UF Hazard and Exposure Based Special FQPA Safety Factor Study and Toxicological Effects Page 7 of 13 Chronic Dietary ( all populations) NOAEL = 25 mg/ kg/ day UF = 100 Chronic RfD = 0.25 mg/ kg/ day FQPA SF = 1 cPAD = chronicRfD FQPA SF = 0.25 mg/ kg/ day Chronic toxicity  dog LOAEL = 125 mg/ kg/ day based on weight loss, slight anemia, evidence of skeletal muscle myopathy and supporting hematology/ clinical chemistry differences Cancer Classification: no evidence of carcinogenicity in mice or rats. " Not Likely To Be Carcinogenic To Humans".

V. Results/ Discussion As stated above, for a chronic assessment, HED is concerned when dietary risk exceeds 100% of the cPAD. The DEEM FCID   analysis estimates the dietary exposure of the U. S. population and various population subgroups. The results reported in Table 3 are for the general U. S. population, all infants (< 1 year old), children 1 2, children 3 5, children 6 12, youth 13 19, females 13 49, adults 20 49, and adults 50+ years. Imazaquin chronic dietary exposure ( food + water) estimates using the DEEM FCID   software were less than 1.0% of the cPAD for the U. S. population and each of the population subgroups. Dietary exposure was estimated at 0.000677 mg/ kg/ day for the U. S. population ( 0.3% of the cPAD) and 0.002208 mg/ kg/ day ( 0.9% of the cPAD) for the most highly exposed population subgroup ( infants, less than 1 year old). More than 95% of the total estimated dietary exposure is from drinking water.

Table 3. Summary of Chronic Dietary Exposure and Risk for Imazaquin1 Population Subgroup Food Only Drinking Water Only Total Exposure ( mg/ kg/ day) % cPAD Exposure ( mg/ kg/ day) % cPAD Exposure ( mg/ kg/ day) % cPAD General U. S. Population 0.000024 0.01 0.000653 0.3 0.000677 0.3 All Infants (< 1 year old) 0.000066 0.03 0.002142 0.9 0.002208 0.9 Children 1 2 years old 0.000053 0.02 0.000970 0.4 0.001023 0.4 Children 3 5 years old 0.000052 0.02 0.000908 0.4 0.000960 0.4 Imazaquin Dietary Exposure Assessment DP Barcode: D302943 PC Code: 128848 Table 3. Summary of Chronic Dietary Exposure and Risk for Imazaquin1 Population Subgroup Food Only Drinking Water Only Total Exposure ( mg/ kg/ day) % cPAD Exposure ( mg/ kg/ day) % cPAD Exposure ( mg/ kg/ day) % cPAD Page 8 of 13 Children 6 12 years old 0.000036 0.01 0.000627 0.3 0.000663 0.3 Youth 13 19 years old 0.000023 0.01 0.000472 0.2 0.000496 0.2 Adults 20 49 years old 0.000019 0.01 0.000610 0.2 0.000629 0.3 Adults 50+ years old 0.000015 0.01 0.000642 0.3 0.000657 0.3 Females 13 49 years old 0.000018 0.01 0.000608 0.2 0.000626 0.3 1The population subgroup with the highest estimated chronic exposure and risk is indicated by bold text..

VI. Characterization of Inputs/ Outputs These chronic dietary exposure and risk estimates are conservative since they assumed 100% crop treated and tolerance level residues and were based on screening level estimates of drinking water concentrations generated by the SCI GROW model. They could be further refined through the use of anticipated residues and percent crop treated data, as well as refined drinking water estimates. However, since estimated exposures and risks using conservative assumptions are well below HED's level of concern, such refinement is not warranted.

VII. Conclusions This Tier 1 chronic dietary exposure analysis using DEEM FCID   indicates that chronic dietary exposure to imazaquin from food and drinking water is well below HED's level of concern for this pesticide. Estimated chronic dietary exposures are less than 1% of the cPAD for the general U. S. population and all population subgroups.

VIII. List of Attachments ° Chronic Food Residue Input file. ° Chronic Results file. ° Commodity Contribution Reports for U. S. Population and Infants Imazaquin Dietary Exposure Assessment DP Barcode: D302943 PC Code: 128848 Page 9 of 13 U. S. Environmental Protection Agency Ver. 2.00 DEEM FCID Chronic analysis for IMAZAQUIN 1994 98 data Residue file: C:\ DEEMFCID\ Imazaquin\ ImazaquinChronicFood+ Water. R98 Adjust. # 2 NOT used Analysis Date 09 21 2005 Residue file dated: 09 21 2005/ 10: 09: 34/ 8 Reference dose ( RfD) = 0.25 mg/ kg bw/ day Comment: Chronic Food ( soybean) plus Water; cPAD = 0.25 mg/ kg/ day  Food Crop Residue Adj. Factors Comment EPA Code Grp Food Name ( ppm) # 1 # 2        06003470 6 Soybean, seed 0.050000 1.000 1.000 06003480 6 Soybean, flour 0.050000 1.000 1.000 06003481 6 Soybean, flour babyfood 0.050000 1.000 1.000 06003490 6 Soybean, soy milk 0.050000 1.000 1.000 06003491 6 Soybean, soy milk babyfood or in 0.050000 1.000 1.000 06003500 6 Soybean, oil 0.050000 1.000 1.000 06003501 6 Soybean, oil babyfood 0.050000 1.000 1.000 86010000 O Water, direct, all sources 0.031000 1.000 1.000 86020000 O Water, indirect, all sources 0.031000 1.000 1.000 Imazaquin Dietary Exposure Assessment DP Barcode: D302943 PC Code: 128848 Page 10 of 13 U. S. Environmental Protection Agency Ver. 2.00 DEEM FCID Chronic analysis for IMAZAQUIN ( 1994 98 data) Residue file name: C:\ DEEMFCID\ Imazaquin\ ImazaquinChronicFood+ Water. R98 Adjustment factor # 2 NOT used. Analysis Date 09 21 2005/ 10: 11: 33 Residue file dated: 09 21 2005/ 10: 09: 34/ 8 Reference dose ( RfD, Chronic) = .25 mg/ kg bw/ day COMMENT 1: Chronic Food ( soybean) plus Water; cPAD = 0.25 mg/ kg/ day =============================================================================== Total exposure by population subgroup  Total Exposure  Population mg/ kg Percent of Subgroup body wt/ day Rfd    U. S. Population ( total) 0.000677 0.3%

U. S. Population ( spring season) 0.000671 0.3% U. S. Population ( summer season) 0.000725 0.3% U. S. Population ( autumn season) 0.000655 0.3% U. S. Population ( winter season) 0.000656 0.3%

Northeast region 0.000618 0.2% Midwest region 0.000685 0.3% Southern region 0.000644 0.3% Western region 0.000774 0.3%

Hispanics 0.000766 0.3% Non hispanic whites 0.000660 0.3% Non hispanic blacks 0.000645 0.3% Non hisp/ non white/ non black 0.000832 0.3%

All infants (< 1 year) 0.002208 0.9% Nursing infants 0.000815 0.3% Non nursing infants 0.002737 1.1% Children 1 6 yrs 0.000964 0.4% Children 7 12 yrs 0.000628 0.3%

Females 13 19 ( not preg or nursing) 0.000480 0.2% Females 20+ ( not preg or nursing) 0.000668 0.3% Females 13 50 yrs 0.000651 0.3% Females 13+ ( preg/ not nursing) 0.000657 0.3% Females 13+ ( nursing) 0.000927 0.4%

Males 13 19 yrs 0.000507 0.2% Males 20+ yrs 0.000605 0.2% Seniors 55+ 0.000656 0.3%

Children 1 2 yrs 0.001023 0.4% Children 3 5 yrs 0.000960 0.4% Children 6 12 yrs 0.000663 0.3% Youth 13 19 yrs 0.000496 0.2% Adults 20 49 yrs 0.000629 0.3% Adults 50+ yrs 0.000657 0.3% Imazaquin Dietary Exposure Assessment DP Barcode: D302943 PC Code: 128848 Page 11 of 13 Females 13 49 yrs 0.000626 0.3%

U. S. Environmental Protection Agency Ver. 2.00 DEEM FCID Chronic analysis for IMAZAQUIN ( 1994 98 data) Residue file name: C:\ DEEMFCID\ Imazaquin\ ImazaquinChronicFood+ Water. R98 Adjustment factor # 2 NOT used. Analysis Date 09 21 2005/ 10: 11: 38 Residue file dated: 09 21 2005/ 10: 09: 34/ 8 Reference dose ( RfD, Chronic) = .25 mg/ kg bw/ day COMMENT 1: Chronic Food ( soybean) plus Water; cPAD = 0.25 mg/ kg/ day =============================================================================== Complete commodity contribution analysis for U. S. Population ( total)

Crop Group = ( O) Other Exposure Analysis  Residue Adjustment mg/ kg Percent of Food Name ( ppm) Factors body wt/ day RfD      Water, direct, all sources ( 86010000): FoodForm N/ S 0.031000 1.000 1.000 0.0003762 0.2% Water, indirect, all sources ( 86020000): FoodForm N/ S 0.031000 1.000 1.000 0.0002772 0.1%   Crop group subtotal 0.0006534 0.3%

Crop Group = ( 6) Legume Vegetables ( Succulent or Dried) Exposure Analysis  Residue Adjustment mg/ kg Percent of Food Name ( ppm) Factors body wt/ day RfD      Soybean, seed ( 06003470): FoodForm N/ S 0.050000 1.000 1.000 0.0000002 0.0% Soybean, flour ( 06003480): FoodForm N/ S 0.050000 1.000 1.000 0.0000006 0.0% Soybean, flour babyfood ( 06003481): FoodForm N/ S 0.050000 1.000 1.000 0.0000002 0.0% Soybean, soy milk ( 06003490): FoodForm N/ S 0.050000 1.000 1.000 0.0000011 0.0% Soybean, soy milk babyfood or infant fo ( 06003491): FoodForm N/ S 0.050000 1.000 1.000 no exposure Soybean, oil ( 06003500): FoodForm N/ S 0.050000 1.000 1.000 0.0000208 0.0% Soybean, oil babyfood ( 06003501): FoodForm N/ S 0.050000 1.000 1.000 0.0000007 0.0%   Crop group subtotal 0.0000236 0.0%

Population subgroup total 0.0006770 0.3%  Imazaquin Dietary Exposure Assessment DP Barcode: D302943 PC Code: 128848 Page 12 of 13 1 U. S. Environmental Protection Agency Ver. 2.00 DEEM FCID Chronic analysis for IMAZAQUIN ( 1994 98 data) Residue file name: C:\ DEEMFCID\ Imazaquin\ ImazaquinChronicFood+ Water. R98 Adjustment factor # 2 NOT used. Analysis Date 09 21 2005/ 10: 11: 38 Residue file dated: 09 21 2005/ 10: 09: 34/ 8 Reference dose ( RfD, Chronic) = .25 mg/ kg bw/ day COMMENT 1: Chronic Food ( soybean) plus Water; cPAD = 0.25 mg/ kg/ day =============================================================================== Complete commodity contribution analysis for All infants (< 1 year)

Crop Group = ( O) Other Exposure Analysis  Residue Adjustment mg/ kg Percent of Food Name ( ppm) Factors body wt/ day RfD      Water, direct, all sources ( 86010000): FoodForm N/ S 0.031000 1.000 1.000 0.0002854 0.1% Water, indirect, all sources ( 86020000): FoodForm N/ S 0.031000 1.000 1.000 0.0018568 0.7%   Crop group subtotal 0.0021422 0.9%

Crop Group = ( 6) Legume Vegetables ( Succulent or Dried) Exposure Analysis  Residue Adjustment mg/ kg Percent of Food Name ( ppm) Factors body wt/ day RfD      Soybean, seed ( 06003470): FoodForm N/ S 0.050000 1.000 1.000 0.0000000 0.0% Soybean, flour ( 06003480): FoodForm N/ S 0.050000 1.000 1.000 0.0000002 0.0% Soybean, flour babyfood ( 06003481): FoodForm N/ S 0.050000 1.000 1.000 0.0000149 0.0% Soybean, soy milk ( 06003490): FoodForm N/ S 0.050000 1.000 1.000 no exposure Soybean, soy milk babyfood or infant fo ( 06003491): FoodForm N/ S 0.050000 1.000 1.000 no exposure Soybean, oil ( 06003500): FoodForm N/ S 0.050000 1.000 1.000 0.0000058 0.0% Soybean, oil babyfood ( 06003501): FoodForm N/ S 0.050000 1.000 1.000 0.0000451 0.0%   Crop group subtotal 0.0000660 0.0% Imazaquin Dietary Exposure Assessment DP Barcode: D302943 PC Code: 128848 Page 13 of 13 Population subgroup total 0.0022082 0.9%