[Federal Register Volume 77, Number 45 (Wednesday, March 7, 2012)]
[Notices]
[Pages 13611-13612]
[FR Doc No: 2012-5487]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]

Arthritis 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: Arthritis 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 May 8, 2012, from 8:30
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 ``Public Meetings at the FDA White Oak
Campus.'' Please note that visitors to the White Oak Campus must enter
through Building 1.
    Contact Person: Philip Bautista, 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-
8533, 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 discuss supplemental biologics license
application 125249, ARCALYST (rilonacept) injection, Regeneron
Pharmaceuticals, Inc., for the following proposed indication:
``ARCALYST (rilonacept) is an interleukin-1 blocker indicated for the
prevention of gout flares during initiation of uric-acid lowering
therapy in adult patients with gout. ARCALYST has not been studied for
longer than 16 weeks in this clinical setting.''
    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
April 24, 2012. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 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 April 16, 2012. 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 April 17, 2012.
    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 Philip Bautista 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: March 2, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-5487 Filed 3-6-12; 8:45 am]
BILLING CODE 4160-01-P


Final, April 19, 2005 Page 1 of 2 Pages White Paper # 2: How Should States Document A Natural Event?

Date/ Status: April 19, 2005 Final Background: When a State believes that a natural event has caused a measured exceedance of the NAAQS, the Natural Events Policy ( NEP) requires the State to establish a clear causal relationship between the measured exceedance and the natural event through the use of filter analysis, meteorological data, modeling/ receptor analysis, video/ photographs or news accounts of the event. The type and amount of documentation required for the event should be sufficient to show that ( 1) the natural event occurred, ( 2) it impacted a monitoring site in such a way as to cause the measured PM10 concentration, and ( 3) absent the event, PM10 concentrations would not have exceeded the NAAQS.

Documentation of a natural event is to be made available to the public for review and comment to allow for discussions about the event, its causes, actions taken and the issue of attainment/ non attainment. The NEP requires the State to submit the data to the EPA Air Quality System ( AQS) within 180 days from the time of the event with a request to flag the data. The NEP requires EPA staff to acknowledge receipt of the documentation and confirm that the request to flag the data as a natural event has taken place within 60 days of receipt of the request.

Discussion: The NEP was written with the understanding that each State is the " expert" on the causes of air pollution episodes within their jurisdiction. The NEP is not clear about what data is necessary to constitute a " clear causal relationship." In the absence of national guidance on necessary data, the regions have not been consistent in how they have treated documentation submitted by the states. Furthermore, if the Region and State disagree on the adequacy of the documentation, there is no mechanism identified other than the courts to resolve the dispute, which may result in a very protracted resolution process.

Recommendations:

The Workgroup recommends that soon after the policy is revised:

a. EPA collaborate with the States to issue guidance on the documentation requirements that is implemented consistently from region to region and State to State. The goal is documentation that is simple, technically sound and, to the extent possible, based on readily available information.

b. As part of the national guidance, EPA and the States work together to establish a mutually acceptable dispute resolution mechanism that relies on a technical evaluation of the documentation versus an administrative evaluation by an independent third party, and will result in a timely resolution of issues as they arise. Final, April 19, 2005 Page 2 of 2 Pages c. EPA regional offices work with the States within their region to develop criteria for appropriate documentation based on the national guidance.

Task Group Members: Gerry Guay, Alaska  author Dave McNeill, Utah  reviewer, editor Doug Schneider, Washington  reviewer, editor


[Federal Register: January 5, 2010 (Volume 75, Number 2)]
[Notices]
[Page 479-482]
[DOCID:fr05ja10-149]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-61244; File No. SR-NYSEAmex-2009-81]

Self-Regulatory Organizations; NYSE Amex LLC; Order Approving the
Proposed Rule Change, as Modified by Amendment No. 1, Amending NYSE
Amex Equities Rule 123C To Modify the Procedures for Its Closing
Process and Make Conforming Changes to NYSE Amex Equities Rule 13 and
Rule 15

December 28, 2009.

I. Introduction

    On November 9, 2009, the NYSE Amex LLC (``NYSE Amex'' 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 modify the procedures for its closing process
in Rule 123C and make conforming changes to NYSE Amex Equities Rules 13
(``Definitions of Orders'') and Rule 15 (``Pre-Opening Indications'').
The proposed rule change was published for comment in the Federal
Register on November 17, 2009.\3\ On November 25, 2009, the Exchange
filed Amendment No. 1 to the proposed rule change.\4\ The Commission
received no comment letters on the proposal; however, the Commission
received one comment letter on the parallel NYSE proposal \5\ which is
germane to this proposal.\6\ This order

approves the proposed rule change as amended.
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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. 60973 (November 9,
2009), 74 FR 59308 (``Notice'').
    \4\ In Amendment No. 1, the Exchange proposes to correct an
erroneous cross-reference in Exhibit 5. Because Amendment No. 1 is
technical in nature, the Commission is not publishing it for
comment.
    \5\ See Securities Exchange Act Release No. 60974 (November 9,
2009), 74 FR 59299 (November 17, 2009) (SR-NYSE-2009-111).
    \6\ See Letter from John F. Neary, Managing Director, Morgan
Stanley, to Elizabeth M. Murphy, Secretary, Commission, dated
December 8, 2009 (``Morgan Stanley Letter''). While the Morgan
Stanley Letter welcomed the incremental progress under the proposal
with regard to transparency, the commenter urged the Exchange to
adopt additional changes to the closing process, including mandating
a final and absolute cutoff time for participation in the closing
process and instituting a more transparent and accurate calculation
of the real time closing imbalance feed.
     On December 18, 2009, the Exchange responded to the Morgan
Stanley letter. See Letter from Janet M. Kissane, Senior Vice
President--Legal & Corporate Secretary, NYSE Euronext, to Elizabeth
M. Murphy, Secretary, Commission (``Response Letter''). In the
Response Letter, the Exchange noted that it took into consideration
input provided by its diverse constituent base, including Morgan
Stanley, in crafting the changes to the closing process, as well as
accommodating the interests of diverse constituencies whose business
models vary widely, and ensuring that changes are implemented in a
way that minimizes the possibility of unintended consequences. The
Exchange stated that, given available development resources and the
complexity of modern markets, it was hesitant to introduce a level
of incremental change that could have broad-ranging and unforeseen
consequences. The Exchange noted further that, as it implements the
changes to the closing process, it will continue to work with its
varied constituency, including Morgan Stanley, to assess the
operation of the closing process, with an eye toward any potential
changes in the behavior of market participants and to identify
further ways to enhance the efficiency and transparency of the
Close.
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II. Description of the Proposal

    The Exchange seeks to amend NYSE Amex Equities Rule 123C to modify
its closing process.\7\ Specifically, the Exchange proposes to amend
NYSE Amex Equities Rule 123C to: (i) Extend the time for the entry of
Market ``At-The-Close'' (``MOC'') and Limit ``At-The-Close'' (``LOC'')
orders from 3:40 p.m. to 3:45 p.m.; (ii) amend the procedures for the
entry of MOC/LOC orders in response to imbalance publications and
regulatory trading halts; (iii) change to the cancellation time for
MOC/LOC orders to 3:58 p.m.; (iv) require only one mandatory imbalance
publication; (v) rescind the provisions governing Expiration Friday
Auxiliary Procedures for the Opening and Due Diligence Requirements;
(vi) modify the dissemination of Order Imbalance Information pursuant
to NYSE Amex Equities Rule 123C(6) to commence at 3:45 p.m.; (vii)
include additional information in both the pre-opening and pre-closing
Order Imbalance Information data feeds; (viii) amend NYSE Amex Equities
Rule 13 to create a conditional-instruction limit order type called the
Closing Offset Order (``CO order''); (ix) delete the ``At the Close''
order type from NYSE Amex Equities Rule 13 and replace it with the
specific definitions of MOC and LOC orders; and (x) codify the
hierarchy of allocation of interest in the closing transaction in NYSE
Amex Equities Rule 123(C). Similar changes to the rules of the New York
Stock Exchange LLC have recently been approved.\8\
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    \7\ Conforming changes related to the information disseminated
prior to the opening transaction are also proposed.
    \8\ See Securities Exchange Act Release No. 61233 (December 23,
2009) (SR-NYSE-2009-111).
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    The Exchange stated in its filing that it seeks to build on changes
it made earlier this year to simplify its closing procedures in order
to provide customers with a more efficient closing process.\9\ The
closing transaction on the Exchange continues to be a manual auction,
which the Exchange believes facilitates greater price discovery and
allows for the maximum interaction between market participants. While
the Exchange currently provides DMM units with electronic tools to
facilitate an efficient closing process, the Exchange believes that the
proposed changes would maximize the use of those tools and allow for an
even more efficient closing process.
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    \9\ See Notice, supra note 3, at pp. 59308-13 for a detailed
description of the current closing process.
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Order Entry, Cancellation, Mandatory MOC/LOC Imbalance and
Informational Imbalance Publications

    The Exchange proposes to amend NYSE Amex Equities Rule 123C to
require electronic entry of all MOC and LOC orders, including those
entered to offset imbalances.\10\ The Exchange stated that electronic
entry of MOC and LOC interest would obviate the need to have imbalance
publications at both 3:40 p.m. and 3:50 p.m. because the DMM would not
have to manually keep track of the MOC/LOC interest; rather, Exchange
systems would track the electronically entered MOC/LOC interest, which
the Exchange believes would allow its systems to disseminate imbalance
information to all market participants in a more accurate and timely
fashion. In addition, according to the Exchange, its customers have
expressed that in the current trading environment, two imbalance
publications ten minutes apart are not useful. Accordingly, the
Exchange proposes to modify the order information available prior to
the closing transaction and amend NYSE Amex Equities Rule 123C to
provide for a single imbalance publication as soon as practicable after
3:45 p.m., to be referred to as the ``Mandatory MOC/LOC Imbalance
Publication'' (herein ``Mandatory MOC/LOC Imbalance''), when there is
an imbalance: (i) Of 50,000 shares or more; or (ii) of less than 50,000
shares that is deemed to be ``significant'' (i.e., significant in
relation to the average daily volume of the security).\11\ The last
sale price at 3:45 p.m. would serve as the basis for the Mandatory MOC/
LOC Imbalance.
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    \10\ In the event a Floor broker's handheld device malfunctions,
the DMM should assist the Floor broker by entering or cancelling
MOC/LOC orders on the Floor broker's behalf. DMMs perform this
administrative function on a best efforts basis. See NYSE
Information Memos 09-26 (June 18, 2009); NYSE Member Education
Bulletin 05-24 (December 9, 2005).
    \11\ See proposed NYSE Amex Equities Rule 123C(1)(d) and (4).
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    The proposal retains the current ability to publish an
Informational Imbalance of any size. The Exchange seeks to extend the
time for the publication of such imbalance from 3:40 p.m. until 3:45
p.m. in order to provide a mechanism for an imbalance publication prior
to any Mandatory MOC/LOC Imbalance if the DMM, in consultation with a
Floor Official or qualified NYSE Euronext employee as defined in
Supplementary Material .10 of NYSE Amex Equities Rule 46, deems that
such imbalance publication is warranted for the security. In extending
the time to 3:45 p.m., the proposed rule would provide that a Mandatory
MOC/LOC Imbalance or ``no imbalance'' notice must occur as soon as
possible after 3:45 p.m.\12\
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    \12\ See proposed NYSE Amex Equities Rule 123C(1)(b) and (4).
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    The proposed new rule would further explicitly state that the entry
of MOC/LOC orders in response to a Mandatory MOC/LOC Imbalance after
3:45 p.m. may be entered only to offset the published imbalance.\13\ In
the case of a ``no imbalance'' notification, no offsetting MOC/LOC
interest could be entered at all after 3:45 p.m.\14\
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    \13\ See proposed NYSE Amex Equities Rule 123C(2)(b)(i).
    \14\ See proposed NYSE Amex Equities Rule 123C(2)(b)(ii).
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    The Exchange's proposal also allows customers to cancel or reduce
MOC/LOC orders only in cases of legitimate errors \15\ between 3:45
p.m. and 3:58 p.m.\16\ After 3:58 p.m., cancellations or reductions in
the size of MOC/LOC orders, even in the event of legitimate error,
would not be permitted.\17\
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    \15\ Pursuant to proposed NYSE Amex Equities Rule 123C(1)(c), a
legitimate error is defined to be an error in any term of an MOC or
LOC order, such as price, number of shares, side of the transaction
(buy or sell) or identification of the security.
    \16\ See proposed NYSE Amex Equities Rule 123C(3) (Cancellation
of MOC and LOC orders). The Exchange anticipates that DMMs will have
sufficient time to perform the requisite calculations for the
closing transaction while affording customers the ability to cancel
or reduce in size an MOC/LOC order until 3:58 p.m.
    \17\ The Exchange could temporarily suspend the prohibitions on
canceling or reducing an MOC or LOC order if there is an extreme
order imbalance at or near the close. See proposed NYSE Amex
Equities Rule 123C(9).

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    The Exchange further proposes to create a CO order type, which
would provide all market participants an additional method to offset an
order imbalance at the close. The CO order would not be guaranteed to
participate in the closing transaction. CO orders would only be
eligible to participate in the closing transaction when there is an
imbalance of orders to be executed on the opposite side of the market
from the CO order and there is no other interest remaining to trade at
the closing price. CO orders must yield to all other eligible interest.
    Unlike MOC/LOC orders, CO orders could be entered on any side of
the market at anytime prior to the close.\18\ CO orders would not be
included in the calculation of the Mandatory MOC/LOC Imbalance and
Informational Imbalance. Consistent with the cancellation requirements
for MOC and LOC orders, a CO order could be cancelled or reduced for
any reason up to 3:45 p.m. Between 3:45 p.m. and 3:58 p.m., a CO order
could be canceled or reduced only in the case of a legitimate error.
After 3:58 p.m., a CO order, like MOC/LOC orders, could not be
cancelled or reduced for any reason.
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    \18\ See proposed NYSE Amex Equities Rule 123C(2)(b)(iv).
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    CO orders would be eligible to participate in the closing
transaction only to offset an imbalance and could not add to or flip
the imbalance. If there is an imbalance at the close and the price of
the closing transaction is at or within the limit of the CO order, the
CO order would be eligible to participate in the closing transaction,
subject to strict time priority of receipt in Exchange systems among
such eligible CO orders and after yielding to all other interest in the
closing execution, including MOCs, marketable LOCs, ``G'' orders, DMM
interest, and at-priced LOCs. CO orders deemed eligible to participate
in the close would be executed at the price of the closing transaction.
If the number of shares represented by CO orders is larger than the
number of shares required to offset the imbalance, Exchange systems
would execute only those shares of CO orders required to complete the
execution of the imbalance in full based on the time priority of
receipt in Exchange systems of the CO orders. CO orders therefore would
not be allowed to swing an imbalance to the opposite side of the
market.

Modifications To Order Imbalance Information Data Feed Prior to the
Closing and Opening Transaction

    The Exchange further proposes to modify the Order Imbalance data
feed disseminated prior to the closing transaction. Pursuant to
proposed NYSE Amex Equities Rule 123C(6)(a)(iii), the Order Imbalance
data feed would be disseminated approximately every five seconds
between 3:45 p.m. and 4 p.m. Moreover, the Exchange proposes to expand
the order information included in the Order Imbalance Information data
feed. Currently, the pre-closing Order Imbalance Information data feed
includes the: (i) Reference price; (ii) MOC/LOC imbalance and the side
of the market; (iii) d-Quotes and all other e-Quotes containing pegging
instructions eligible to participate in the closing transaction; and
(iv) MOC/LOC paired quantity at reference price. The proposed new data
feed would also additionally include (i) CO orders on the opposite side
of the imbalance and (ii) at-priced LOC interest eligible to offset the
imbalance.
    The proposed Order Imbalance Information data feed prior to the
closing transaction would also make available two new data fields. The
proposed new data fields would provide subscribers with a snap shot of
the prices at which interest eligible to participate in the closing
transaction would be executed in full against contra interest at the
time data feed is disseminated. It would also provide subscribers with
the price at which closing-only interest (i.e., MOC orders, marketable
LOC orders, and CO orders on the opposite side of the imbalance) may be
executed in full and the price at which orders in the Display Book
(e.g., Minimum Display Reserve Orders, Floor broker reserve e-Quotes
not designated to be excluded from the aggregated agency interest
information available to the DMM, d-Quotes pegged e-Quotes,\19\ and
Stop orders) would be executed in full. Only those CO orders on the
opposite side of the imbalance would be included in the calculation of
the new data fields. If the price at which all closing orders in the
Display Book would be executed in full is at or between the quote, then
both data fields indicating imbalance information would publish the
price at which the closing-only interest (i.e., MOC orders, marketable
LOC orders, and CO orders) could be executed in full.
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    \19\ d-Quotes and pegged e-Quotes included in this new data
field of the Order Imbalance Information data feed would be included
at the price indicated on the order as the base price to be used to
calculate the range of discretion and not at prices within their
discretionary pricing instructions.
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    Similarly the Exchange proposes to conform the pre-opening Order
Imbalance Information data feed to provide its market participants with
more information prior to the opening transaction. As such, the pre-
opening Order Imbalance Information data feed would include the price
at which all the interest eligible to participate in the opening
transaction may be executed in full.\20\ The Exchange does not propose
to modify the time periods pursuant to NYSE Amex Equities Rule 15 when
the pre-opening Order Imbalance data feed is disseminated. Moreover,
the calculation of the reference price would also remain the same.
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    \20\ See Proposed NYSE Amex Equities Rule 15.
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Execution of the Closing Transaction

    The Exchange proposes to maintain its current execution logic and
to codify the hierarchy of allocation logic applied to interest
participating in the closing transaction. Proposed NYSE Amex Equities
Rule 123C(7) would list all the interest that must be executed or
cancelled as part of the closing transaction and the hierarchy of the
interest that may be used to offset the closing imbalance. This
codification would now also incorporate the new proposed CO order type
into the closing transaction as the last interest eligible to
participate in the closing transaction to offset an imbalance.

Trading Halts

    The Exchange further proposes to amend NYSE Amex Equities Rule 123C
to define ``trading halt'' as a halt in trading in any security
pursuant to the provisions of NYSE Amex Equities Rule 123D (``Trading
Halt'').\21\ Under the proposal, when a Trading Halt is in effect at
3:45 p.m., a Mandatory MOC/LOC Imbalance would be published as close to
the resumption of trading as possible if the Trading Halt is lifted
prior to the close of trading. In this event, MOC/LOC orders could be
entered to offset the published imbalance. If the Trading Halt is not
lifted, the entry of MOC/LOC interest, including offsetting interest,
would be prohibited.
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    \21\ See proposed NYSE Amex Equities Rule 123C(1)(f).
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    Where a Trading Halt occurs in a security after a Mandatory MOC/LOC
Imbalance is published, MOC/LOC orders could be entered to offset the
published imbalance.\22\ Where a Trading Halt occurs after 3:45 p.m.
and there is no Mandatory MOC/LOC

Imbalance in the security, the entry of MOC/LOC interest would not be
allowed.\23\
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    \22\ See proposed NYSE Amex Equities Rule 123C(2)(c)(i).
    \23\ See proposed NYSE Amex Equities Rule 123C(2)(c)(iii).
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    Unlike MOC/LOC orders, the entry of CO orders on both sides of the
market would be permitted when a Trading Halt occurs in a security, but
is lifted prior to the close of trading in the security. Because CO
orders are the interest of last resort in the closing transaction,
entry of such orders is not restricted to offsetting the Mandatory MOC/
LOC Imbalance.

Rescission of Expiration Friday Auxiliary Procedures for the Opening
and Due Diligence Requirements

    The Exchange proposes to rescind the provisions governing
``Expiration Friday Auxiliary Procedures for the Opening.'' According
to the Exchange, the provisions governing Expiration Friday were
created to facilitate a fair and orderly opening transaction in light
of the additional order flow on Expiration Fridays. Because Exchange
systems now allow the DMM to accommodate for such fluctuations in
volume, the Exchange believes that these provisions are unnecessary.
The order marking provisions were an accommodation to member
organizations whose systems were unable to electronically affix the
designation, and the Exchange states that all of its member
organizations are capable of affixing appropriate order designations.
    The Exchange further seeks to make the provisions of NYSE Amex
Equities Rule 123C govern solely Market and Limit ``on the Close''
Policy. Therefore, the Exchange proposes to delete the ``Due Diligence
Requirements'' from this rule as they are redundant with the provisions
codified in NYSE Amex Equities Rule 405.

III. Discussion and Commission Findings

    The Commission finds that the proposed rule change, as amended, is
consistent with the requirements of the Act and the rules and
regulations thereunder applicable to a national securities
exchange.\24\ In particular, it is consistent with Section 6(b)(5) of
the Act,\25\ which requires, among other things, that the rules of a
national securities exchange be designed to promote just and equitable
principles of trade, to remove impediments to and perfect the mechanism
of a free and open market and a national market system and, in general,
to protect investors and the public interest, and not be designed to
permit unfair discrimination between customers, issuers, brokers, or
dealers. The Commission also finds that the proposed rule change as
amended is consistent with the provisions of Section 6(b)(8) of the
Act,\26\ which requires that the rules of an exchange not impose any
burden on competition not necessary or appropriate in furtherance of
the purposes of the Act.
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    \24\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \25\ 15 U.S.C. 78f(b)(5).
    \26\ 15 U.S.C. 78f(b)(8).
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    The electronic entry of MOC/LOC interest should increase the
efficiency of NYSE Amex's market and permit accurate information to be
disseminated to market participants more quickly. The modification of
the procedures for the entry of MOC/LOC orders in response to imbalance
publications and regulatory trading halts should likewise improve
transparency and efficiency.
    In connection with the change from two imbalance publications to
one, the Commission notes the Exchange's representation that its
customers have expressed that two imbalance publications ten minutes
apart in the current electronic environment are unnecessary. Moving the
cut-off time for the entry of MOC/LOC orders from 3:40 p.m. to 3:45
p.m. should allow Exchange participants additional control of the
handling of their orders to be executed in the closing transaction and
additional participation in active markets.
    In connection with the postponing of the cancellation time for MOC
and LOC orders to 3:58 p.m, the Commission notes the Exchange's
representations that, with the proposed requirement that all MOC/LOC
orders be entered electronically, Exchange systems will keep track of
the available interest thus making it more readily available for the
DMM and that systemic tracking of MOC/LOC interest makes it entirely
feasible for the DMM to review in two minutes the interest eligible to
participate in the closing transaction and facilitate the execution of
the closing transaction.
    The creation of the CO order provides an additional source of
liquidity to offset an imbalance going into the closing transaction,
and thus should increase the greater efficiency of the closing process.
    The Commission believes that these proposed modifications are
consistent with the Act because, taken as a whole, they should enhance
the efficiency and transparency of the closing transaction and provide
customers with a more accurate depiction of market conditions prior to
the closing transaction, and therefore allow them to make better-
informed trading decisions.
    The Commission believes that the remainder of the proposed changes,
including the codification of the hierarchy of the allocation of
interest in the closing, the clarification of the definition of MOC and
LOC orders, the inclusion of additional information in the Order
Imbalance Information data feeds, and the rescission of the provisions
governing Expiration Friday Auxiliary Procedures for the Opening and
Due Diligence Requirements are either non-substantive or non-
controversial in nature, while enhancing the transparency of NYSE
Amex's market at the close, and therefore are consistent with the Act.

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\27\ that the proposed rule change, as amended (SR-NYSEAmex-2009-
81), be, and it hereby is, approved.
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    \27\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\28\
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    \28\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-31272 Filed 1-4-10; 8:45 am]

BILLING CODE 8011-01-P


Three metabolites of 1‐bromopropane (1‐BP) were measured in urine samples collected from 30 workers exposed to 1‐BP at two facilities making furniture seat cushions and evaluated for use as biomarkers of exposure. The mercapturic acid metabolite, N‐acetyl‐S‐(n‐propyl)‐l‐cysteine (AcPrCys), 3‐bromopropionic acid (3‐BPA), and bromide ion levels (Br(‐)) were quantitated for this evaluation. The high exposure group consisted of 13 workers employed as adhesive sprayers who assembled foam cushions using 1‐BP containing spray adhesives and the low exposure group consisted of 17 non‐sprayers, who worked in various jobs without spraying adhesives. All workers' urine voids were collected over the same 48 h period at work, and at home before bedtime, and upon awakening. Urinary AcPrCys and Br(‐) levels were elevated in the sprayers compared to that of non‐sprayers. Following HPLC‐MS/MS analysis of mercapturic acid metabolite levels, 50 urine samples having the highest levels of AcPrCys were analyzed for 3‐BPA. No 3‐BPA was detected in any of the samples. The data collected from this study demonstrate that AcPrCys and Br(‐) are effective biomarkers of 1‐BP exposure, but 3‐BPA is not.
Valentine, H., et al. (2007). "Globin s‐propyl cysteine and urinary N‐acetyl‐S‐propylcysteine as internal biomarkers of 1‐bromopropane exposure." Toxicol Sci 98(2): 427‐435.
1‐Bromopropane (1‐BP), an alternative to ozone‐depleting solvents, is a neuro and reproductive toxicant in animals and humans. In this study, the dose responses for urinary AcPrCys and S‐propylcysteine (PrCys) adducts on globin and neurofilaments were determined as a function of 1‐BP exposure level and duration in the rat; and globin PrCys adducts and urinary AcPrCys were quantified in samples obtained from workers in a 1‐BP production facility. Rats were exposed to 1‐BP by inhalation for 2 weeks at 0, 50, 200, or 800 ppm and to 1‐BP at 0 or 50 ppm for 4 weeks. After the 4‐week exposures ended, half of the animals were euthanized immediately and half euthanized 8 days later. Urinary AcPrCys was measured using liquid chromatography‐tandem mass spectrometry (LC/MS/MS) and gas chromatograph‐mass spectrometry (GC/MS); and PrCys adducts were determined on globin and neurofilaments using LC/MS/MS. In rats, PrCys adduct and urinary AcPrCys levels demonstrated a linear dose response relative to exposure level. PrCys globin adducts demonstrated a linear cumulative dose response over the 4‐week exposure period. Elimination of AcPrCys appeared biphasic with detectable levels still present in urine up to 8 days postexposure. A significant increase in globin PrCys adducts was observed in the 1‐BP workers relative to control workers; and urinary AcPrCys increased with increasing 1‐BP ambient exposure levels. The results of these studies demonstrate the ability of 1‐BP to covalently modify proteins in vivo and support the potential of urinary AcPrCys and globin PrCys adducts to serve as biomarkers of 1‐BP exposure in humans.


[Federal Register Volume 77, Number 177 (Wednesday, September 12, 2012)]
[Rules and Regulations]
[Pages 56133-56138]
[FR Doc No: 2012-22205]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0433; FRL-9359-6]

Dinotefuran; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
dinotefuran in or on multiple commodities which are identified and
discussed later in this document. Also, due to the tolerances
established by this document, the Agency is removing the existing
tolerances for grape and potato as unnecessary. Interregional Research
Project Number 4 (IR-4) requested these tolerances under the Federal
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective September 12, 2012. Objections and
requests for hearings must be received on or before November 13, 2012,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2011-0433, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Andrew Ertman, Registration Division,
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703) 308-9367; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2011-0433 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
November 13, 2012. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2011-0433, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.htm.

Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of September 7, 2011 (76 FR 55329) (FRL-
8886-7), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
1E7863) by IR-4, 500 College Rd. East, Suite 201 W, Princeton, NJ
08540. The petition requested that 40 CFR 180.603 be amended by
establishing tolerances for residues of the insecticide dinotefuran,
(RS)-1-methyl-2-nitro-3-((tetrahydro-3-furyl)methyl)guanidine,
including its metabolites and degradates, in or on berry, low growing,
except strawberry, subgroup 13-07H at 0.2 parts per million (ppm);
watercress at 5.0 ppm; onion, green, subgroup 3-07B at 6.0 ppm; onion,
bulb, subgroup 3-07A at 0.07 ppm; peach at 0.9 ppm; vegetable, tuberous
and corm, subgroup 1C at 0.05 ppm; fruit, small, vine climbing, except
fuzzy kiwifruit, subgroup 13-07F at 0.9 ppm; and tea, plucked leaves at
25.0 ppm. That notice referenced a summary of the petition prepared by
Mitsui Chemicals Agro, Inc., the registrant, which is available in the
docket, http://www.regulations.gov. There were no comments received in
response to the notice of filing.
    Also, due to the tolerances established by this document, the
following existing tolerances are being removed as unnecessary: Grape
and potato.
    Based upon review of the data supporting the petition, EPA has

modified the levels for which tolerances are being established for the
bulb onion subgroup 3-07A, the green onion subgroup 3-07B, peach, tea,
and watercress. The reason for these changes is explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. * *
*''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for dinotefuran including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with dinotefuran follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Dinotefuran has low acute toxicity by oral, dermal, and
inhalation exposure routes. It is not a dermal sensitizer, but causes a
low level of skin irritation. The main target of toxicity is the
nervous system but effects on the nervous system were only observed at
high doses. Nervous system toxicity was manifested as clinical signs
and decreased motor activity seen after acute dosing (in both rats and
rabbits) and changes in motor activity which are consistent with
effects on the nicotinic cholinergic nervous system seen after repeated
dosing. Typically, low to moderate levels of neonicotinoids, such as
dinotefuran, activate the nicotinic acetylcholine receptors causing
stimulation of the peripheral nervous system (PNS). High levels of
neonicotinoids can over stimulate the PNS, maintaining cation channels
in the open state which blocks the action potential and leads to
paralysis.
    Dinotefuran was well tolerated at high doses following dietary
administration for ninety days to mice, rats, and dogs. The most
sensitive effects were decreases in body weight and/or body weight gain
but even these effects occurred at or near the limit dose. Changes in
spleen and thymus weights were seen in mice, rats and dogs following
subchronic and chronic dietary exposures. However, these weight changes
were not corroborated with alterations in hematology parameters,
histopathological lesions in these organs, or toxicity to the
hematopoietic system. Furthermore, the toxicology data base contains
immunotoxicity studies in mice and rats and a developmental
immunotoxicity study in rats. In the immunotoxicity studies there were
no effect on T-cell dependent antibody response (TDAR) when tested up
to the limit dose in male and female mice and in male and female rats.
There were no changes in spleen and thymus weight and there were no
histopathological lesions in these organs in those studies. In the
developmental immunotoxicity study, there was no evidence of an effect
on the functionality of the immune system in rats that were exposed to
dinotefuran at the limit dose during the prenatal, postnatal, and post-
weaning periods. Consequently, the thymus weight changes seen in dogs
and the spleen weight changes seen in mice and rats were not considered
to be toxicologically relevant.
    No systemic or neurotoxicity was seen following repeated dermal
applications at the limit dose to rats for 28 days. No systemic or
portal of entry effects were seen following repeated inhalation
exposure at the maximum obtainable concentrations to rats for 28 days.
    In the pre-natal studies, no maternal or developmental toxicity was
seen at the limit dose in rats. In rabbits, maternal toxicity
manifested as clinical signs of neurotoxicity but no developmental
toxicity was seen. In the reproduction study, parental, offspring, and
reproductive toxicity was seen at the limit dose. Parental toxicity
included decreased body weight gain, transient decrease in food
consumption, and decreased thyroid weights. Offspring toxicity was
characterized as decreased forelimb grip strength or hindlimb grip
strength in the F1 pups. There was no adverse effect on reproductive
performance at any dose. In the developmental neurotoxicity study, no
maternal or offspring toxicity was seen at any dose including the limit
dose.
    There was no evidence of carcinogenicity in male and female mice
and in male and female rats fed diets containing dinotefuran at the
limit dose for 78 weeks to mice and 104 weeks to rats. Dinotefuran was
non-mutagenic in both in vivo and in vitro assays.
    Specific information on the studies received and the nature of the
adverse effects caused by dinotefuran as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov on pages 39-44 of the document titled ``Revised:
Dinotefuran: Human Health Risk Assessment for Proposed Section 3 Uses
on Tuberous and Corm Vegetables Subgroup 1C, Onion Subgroup 3-07A,
Onion Subgroup 3-07B, Small Fruit Subgroup 13-07F, Berry Subgroup 13-
07H, Peach, and Watercress, And a Tolerance on Imported Tea'' in docket
ID number EPA-HQ-OPP-2011-0433.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles

EPA uses in risk characterization and a complete description of the
risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for dinotefuran used for
human risk assessment is shown in the Table of this unit. EPA notes
that in the last final rule for dinotefuran, published in the Federal
Register of December 18, 2009 (74 FR 67098) (FRL-8803-1), the points of
departure for many exposure scenarios differ than what is reported in
this document. Since the last risk assessment, the Agency has re-
evaluated the dinotefuran toxicological database and updated the hazard
characterization and dose response assessment. This toxicology database
reevaluation has resulted in changes to the toxicity endpoints, points
of departure, and safety factors for several routes of exposure from
those presented in previous EPA risk assessments for dinotefuran. For a
more detailed discussion of the endpoint selection and reasons for the
changes, refer to Appendix A.3 on pages 44-47 in the document titled
``Dinotefuran: Human Health Risk Assessment for Proposed Section 3 Uses
on Tuberous and Corm Vegetables Subgroup 1C, Onion Subgroup 3-07A,
Onion Subgroup 3-07B, Small Fruit Subgroup 13-07F, Berry Subgroup 13-
07H, Peach, and Watercress, And a Tolerance on Imported Tea'' in docket
ID number EPA-HQ-OPP-2011-0433.

   Table--Summary of Toxicological Doses and Endpoints for Dinotefuran for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and  uncertainty/    RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population  NOAEL = 125 mg/kg/    Acute RfD = 1.25 mg/ Developmental Toxicity Study in
 including infants and children).   day.                  kg/day.              Rabbits
                                   UFA = 10X...........  aPAD = 1.25 mg/kg/   LOAEL = 300 mg/kg/day based on
                                   UFH = 10X...........   day.                 clinical signs in does (prone
                                   FQPA SF = 1X........                        position, panting, tremor and
                                                                               erythema) seen following the
                                                                               first dose on Gestation Day 6.
Chronic dietary (All populations)  NOAEL= 99.7 mg/kg/    Chronic RfD = 1.0    Chronic Toxicity/Carcinogenicity
                                    day.                  mg/kg/day.           Study in Rats LOAEL = 991 mg/kg/
                                   UFA = 10X...........  cPAD = 1.0 mg/kg/     day based on decreased body
                                   UFH = 10X...........   day.                 weight gain and nephrotoxicity.
                                   FQPA SF = 1X........
Incidental Oral Short-Term (1-30   NOAEL= 99.7 mg/kg/    LOC for MOE = 100..  Chronic Toxicity/Carcinogenicity
 days).                             day.                                       Study in Rats LOAEL = 991 mg/kg/
                                   UFA = 10X...........                        day based on decreased body
                                   UFH = 10X...........                        weight gain and nephrotoxicity.
                                   FQPA SF = 1X........
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to dinotefuran, EPA considered exposure under the petitioned-
for tolerances as well as all existing dinotefuran tolerances in 40 CFR
180.603. EPA assessed dietary exposures from dinotefuran in food as
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    Such effects were identified for dinotefuran. In estimating acute
dietary exposure, EPA used food consumption information from the United
States Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue
levels in food, EPA assumed 100 percent crop treated (PCT) and
tolerance-level residues for all current and proposed crops.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA assumed 100 PCT and
tolerance-level residues for all current and proposed crops.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that dinotefuran does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use
anticipated residue or PCT information in the dietary assessment for
dinotefuran. Tolerance level residues and 100 PCT were assumed for all
food commodities.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for dinotefuran in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of dinotefuran. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the First Index Reservoir Screening Tool (FIRST), and
Screening Concentration in Ground Water (SCI-GROW) models, the
estimated drinking water concentrations (EDWCs) of dinotefuran for
acute exposures are estimated to be 91.31 parts per billion (ppb) for
surface water and 3.5 ppb for ground water and for chronic exposures
for non-cancer assessments are estimated to be 25.16 ppb for surface
water and 3.5 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 91.31 ppb was used to
assess the contribution to drinking water. For chronic dietary risk

assessment, the water concentration of value 25.16 ppb was used to
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Dinotefuran is currently registered for the following uses that
could result in residential exposures: Turf, ornamentals, vegetable
gardens, pets, indoor aerosol sprays, and crack and crevice sprays. EPA
assessed residential exposure using the following assumptions:
Residential handler exposures were not assessed because no dermal or
inhalation hazards were identified. For this same reason, post-
application residential dermal and inhalation exposure scenarios were
not assessed. The Agency only considered post-application scenarios in
which incidental oral exposures to children are expected. The oral
exposures assessed included incidental oral exposures from turf, ant
bait, ready to use garden trigger sprayers, dog and cat spot on
treatment, indoor broadcast, and indoor crack and crevice uses. Of all
these scenarios, treated turf was determined to result in the highest
levels of exposure.
    In assessing risks from residential exposures, EPA combines
different residential sources of exposure that could reasonably be
expected to occur on the same day. While it is possible for children to
be exposed to indoor broadcast sprays on hard surfaces/carpets and to
spot-on treatment to cats or dogs on the same day, these exposures have
not been combined in this assessment because incidental oral hand-to-
mouth exposure from treated turf is higher and still results in an MOE
that does not exceed the Agency's LOC.
    Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found dinotefuran to share a common mechanism of
toxicity with any other substances, and dinotefuran does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
dinotefuran does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. In the pre-natal studies, no
maternal or developmental toxicity was seen at the limit dose in rats.
In rabbits, maternal toxicity manifested as clinical signs of
neurotoxicity but no developmental toxicity was seen. In the
reproduction study, parental, offspring, and reproductive toxicity was
seen at the limit dose. Parental toxicity included decreased body
weight gain, transient decrease in food consumption, and decreased
thyroid weights. Offspring toxicity was characterized as decreased
forelimb grip strength or hindlimb grip strength in the F1 pups. There
was no adverse effect on reproductive performance at any dose. In the
developmental neurotoxicity study, no maternal or offspring toxicity
was seen at any dose including the limit dose.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for dinotefuran is complete.
    ii. The neurotoxic potential of dinotefuran has been adequately
considered. Dinotefuran is a neonicotinoid and has a neurotoxic mode of
pesticidal action. Consistent with the mode of action, changes in motor
activity were seen in repeat-dose studies, including the subchronic
neurotoxicity study. Additionally, decreased grip strength and brain
weight was observed in the offspring of a multi-generation reproduction
study albeit at doses close to the limit dose. For these reasons, a
developmental neurotoxicity study was required. Upon review of the
developmental neurotoxicity study, it was concluded that there is no
evidence of a unique sensitivity to the developing nervous system since
no effects on neurobehavioral parameters were seen in the offspring at
doses that approached or exceeded the limit dose.
    iii. There is no evidence that dinotefuran results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to dinotefuran in drinking water. EPA used similarly
conservative assumptions to assess postapplication exposure of children
for incidental oral exposures. These assessments will not underestimate
the exposure and risks posed by dinotefuran.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to dinotefuran will occupy 5.8% of the aPAD for children 1-2 years old,
the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
dinotefuran from food and water will utilize 2.6% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. Based on the explanation in

Unit III.C.3., regarding residential use patterns, chronic residential
exposure to residues of dinotefuran is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    Dinotefuran is currently registered for uses that could result in
short-term residential exposure, and the Agency has determined that it
is appropriate to aggregate chronic exposure through food and water
with short-term residential exposures to dinotefuran.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in an aggregate MOE of 3,000 for
children 1-2 years old from hand to mouth exposure from treated turf,
the scenario with the highest exposure. Because EPA's level of concern
for dinotefuran is a MOE of 100 or below, this MOE is not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
    Intermediate-term exposure is not expected for the adult
residential exposure pathway. Therefore, the intermediate-term
aggregate risk would be equivalent to the chronic dietary exposure
estimate. For children, intermediate-term incidental oral exposures
could potentially occur from indoor uses. However, while it is possible
for children to be exposed for longer durations, the magnitude of
residues is expected to be lower due to dissipation or other
activities. Since incidental oral short- and intermediate-term toxicity
endpoints and points of departure are the same, the short-term
aggregate risk estimate, which includes the highest residential
exposure estimate (from turf), is protective of any intermediate-term
exposures.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, dinotefuran is not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population or to infants and children from aggregate
exposure to dinotefuran residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (a high performance liquid
chromatography/tandem mass spectrometry (HPLC/MS/MS) method for the
determination of residues of dinotefuran, and the metabolites DN, and
UF; an HPLC/ultraviolet (UV) detection method for the determination of
residues of dinotefuran; and HPLC/MS and HPLC/MS/MS methods for the
determination of DN and UF) is available to enforce the tolerance
expression.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established a MRL for dinotefuran for any of the
commodities in this Notice.

C. Revisions to Petitioned-For Tolerances

    Use of the Organization of Economic and Cooperation and Development
tolerance calculation procedures indicates that the tolerances for
residues in/on the onion subgroup 3-07A, onion subgroup 3-07B, peach,
tea, and watercress should be established at 0.15 ppm, 5.0 ppm, 1.0
ppm, 50 ppm, and 8.0 ppm, respectively, instead of those values
proposed.

V. Conclusion

    Therefore, tolerances are established for residues of dinotefuran,
(RS)-1-methyl-2-nitro-3-((tetrahydro-3-furyl)methyl)guanidine,
including its metabolites and degradates, in or on berry, low growing,
except strawberry, subgroup 13-07H at 0.2 ppm; watercress at 8.0 ppm;
onion, green, subgroup 3-07B at 5.0 ppm; onion, bulb, subgroup 3-07A at
0.15 ppm; peach at 1.0 ppm; vegetable, tuberous and corm, subgroup 1C
at 0.05 ppm; fruit, small, vine climbing, except fuzzy kiwifruit,
subgroup 13-07F at 0.9 ppm; and tea, dried at 50 ppm.
    Also, the following existing tolerances are removed as unnecessary:
Grape and potato. These commodities are covered by the new crop group
tolerances for fruit, small, vine climbing, except fuzzy kiwifruit,
subgroup 13-07F, and vegetable, tuberous and corm, subgroup 1C.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this final rule has
been exempted from review under Executive Order 12866, this final rule
is not subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions

of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: August 28, 2012.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

0
2. Section Sec.  180.603 is amended by removing the entries for
``Grape'' and ``Potato'' and alphabetically adding the following
entries and a footnote to the table in paragraph (a)(1) to read as
follows:

Sec.  180.603  Dinotefuran; tolerances for residues.

    (a) * * *
    (1) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Berry, low growing, except strawberry, subgroup 13-07H....          0.2

                              * * * * * * *
Fruit, small vine climbing, except fuzzy kiwifruit,                 0.9
 subgroup 13-07F..........................................

                              * * * * * * *
Onion, bulb, subgroup 3-07A...............................          0.15
Onion, green, subgroup 3-07B..............................          5.0
Peach.....................................................          1.0

                              * * * * * * *
Tea, dried\1\.............................................         50

                              * * * * * * *
Vegetable, tuberous and corm, subgroup 1C.................          0.05
Watercress................................................          8.0
------------------------------------------------------------------------
\1\ There are no U.S. registrations for tea.

* * * * *
[FR Doc. 2012-22205 Filed 9-11-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: August 18, 2008 (Volume 73, Number 160)]
[Notices]
[Page 48209-48210]
[DOCID:fr18au08-49]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP08-449-000]

Texas Gas Transmission, LLC; Notice of Request Under Blanket
Authorization

August 8, 2008.
    Take notice that on August 1, 2008, Texas Gas Transmission, LLC
(Texas Gas), 3800 Frederica Street, Owensboro, Kentucky 42301, filed in
Docket No. CP08-449-000, a prior notice request pursuant to sections
157.205, 157.208, and 157.212 of the Federal Energy Regulatory
Commission's regulations under the Natural Gas Act for authorization to
construct, own, and operate a new interconnect on Texas Gas' Eunice
Thibodaux system, located in Acadia Parish, Louisiana, in order to
receive revaporized liquefied natural gas (LNG) from Kinder Morgan
Louisiana Pipeline LLC (KMLP), all as more fully set forth in the
application, which is on file with the Commission and open to public
inspection. The filing may also be viewed on the web 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 at

<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or TTY,
(202) 502-8659.
    Specifically, Texas Gas proposes to construct two sixteen-inch side
valves, approximately fifty feet of connecting 20-inch piping,
overpressure protection equipment with bypass, electronic flow
measurement equipment, communication equipment, and other appurtenant
auxiliary facilities in order to receive 600 MMcf/d of revaporized LNG
from KMLP, which will directly connect to the Cheniere Sabine Pass LNG
import terminal, located in Cameron Parish, Louisiana. Texas Gas
estimates the cost of construction to be $712,113, with all costs
associated with such facilities to be reimbursed by KMLP. Texas Gas
states that addition of the proposed receipt point will have no
significant impact on Texas Gas' peak day or annual deliveries.
    Any questions regarding the application should be directed to Kathy
D. Fort, Manager of Certificates and Tariffs, Texas Gas Transmission,
LLC, 3800 Frederica Street, Owensboro, Kentucky 42301, or call (270)
688-6825, fax<PHONE_NUMBER>, or e-mail<EMAIL_ADDRESS>    Any person may, within 60 days after the issuance of the instant
notice by the Commission, file pursuant to Rule 214 of the Commission's
Procedural Rules (18 CFR 385.214) a motion to intervene or notice of
intervention. Any person filing to intervene or the Commission's staff
may, pursuant to section 157.205 of the Commission's Regulations under
the Natural Gas Act (NGA) (18 CFR 157.205) file a protest to the
request. If no protest is filed within the time allowed therefore, the
proposed activity shall be deemed to be authorized effective the day
after the time allowed for protest. If a protest is filed and not
withdrawn within 30 days after the time allowed for filing a protest,
the instant request shall be treated as an application for
authorization pursuant to section 7 of the NGA.
    The Commission strongly encourages electronic filings of comments,
protests, and interventions via the internet in lieu of paper. See 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site (www.ferc.gov) under the ``e-Filing'' link.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-18995 Filed 8-15-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 75, Number 78 (Friday, April 23, 2010)]
[Notices]
[Page 21385]
[FR Doc No: 2010-9297]

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

DEPARTMENT OF TRANSPORTATION

Office of the Secretary

Applications of Atlas Air, Inc. for Certificate Authority

AGENCY: Department of Transportation.

ACTION: Notice of Order to Show Cause (Order 2010-X-X), Dockets DOT-
OST-2009-0267 and DOT-OST-2009-0268.

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

SUMMARY: The Department of Transportation is directing all interested
persons to show cause why it should not issue an order finding Atlas
Air, Inc., fit, willing, and able, and awarding it a certificate of
public convenience and necessity to engage in foreign charter air
transportation of persons, property, and mail.

DATES: Persons wishing to file objections should do so no later than
April 25, 2010.

ADDRESSES: Objections and answers to objections should be filed in
Dockets DOT-OST-2009-0267 and DOT-OST-2009-0268 and addressed to U.S.
Department of Transportation Dockets, 1200 New Jersey Avenue, SE., West
Building Ground Floor, Rm. W12-140, Washington, DC 20590, and should be
served upon the parties listed in Attachment A to the order.

FOR FURTHER INFORMATION CONTACT: Mr. Scott Faulk, Air Carrier Fitness
Division (X-56, Room W86-487), U.S. Department of Transportation, 1200
New Jersey Avenue, SE., West Building, Washington, DC 20590, (202) 366-
9721.

    Dated: April 15, 2010.
Christa Fornaratto,
Deputy Assistant Secretary, for Aviation and International Affairs.
[FR Doc. 2010-9297 Filed 4-22-10; 8:45 am]
BILLING CODE P


[Federal Register Volume 84, Number 152 (Wednesday, August 7, 2019)]
[Notices]
[Page 38704]
[FR Doc No: 2019-16854]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-86545; File No. SR-NASDAQ-2019-049]

Self-Regulatory Organizations; The Nasdaq Stock Market LLC;
Notice of Designation of Longer Period for Commission Action on a
Proposed Rule Change To Amend the Definition of Family Member in
Listing Rule 5605(a)(2) for Purposes of the Definition of Independent
Director

August 1, 2019.
    On May 29, 2019, 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
proposal to modify the definition of a ``Family Member'', for purposes
of the independence of directors, under Nasdaq Rule 5605(a)(2). The
proposed rule change was published for comment in the Federal Register
on June 18, 2019.\3\ The Commission has received no comments on the
proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 86095 (June 12,
2019), 84 FR 28379.
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \4\ provides that, within 45 days of
the publication of the notice of the filing of a proposed rule change,
or within such longer period up to 90 days as the Commission may
designate if it finds such longer period to be appropriate and
publishes its reasons for so finding or as to which the self-regulatory
organization consents, the Commission shall either approve the proposed
rule change, disapprove the proposed rule change, or institute
proceedings to determine whether the proposed rule change should be
disapproved. The 45th day after publication of the notice for this
proposed rule change is August 2, 2019.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    The Commission is extending the 45-day time period for Commission
action on the proposed rule change. The Commission finds that it is
appropriate to designate a longer period within which to take action on
the proposed rule change so that it has sufficient time to consider the
proposed rule change. Accordingly, pursuant to Section 19(b)(2) of the
Act,\5\ the Commission designates September 16, 2019 as the date by
which the Commission shall either approve, disapprove, or institute
proceedings to determine whether to disapprove, the proposed rule
change (File No. SR-NASDAQ-2019-049).
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78s(b)(2)(A)(ii)(I).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
---------------------------------------------------------------------------

    \6\ 17 CFR 200.30-3(a)(31).
---------------------------------------------------------------------------

Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2019-16854 Filed 8-6-19; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 121 (Thursday, June 23, 2011)]
[Notices]
[Pages 36943-36945]
[FR Doc No: 2011-15659]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-64697; File No. SR-OCC-2011-07]

Self-Regulatory Organizations; The Options Clearing Corporation;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Provide an Interpretation to Rule 401 To Allow Clearing Members To Use
OCC Systems To Update Certain Non-critical Trade Data With Respect to
Exchange Transactions Involving Securities Options

June 17, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ notice is hereby given that on June 7, 2011, The Options
Clearing Corporation (``OCC'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change described in Items
I, II, and III below, which Items have been prepared primarily by OCC.
OCC filed the proposal pursuant to Section 19(b)(3)(A)(iii) of the Act
\2\ and Rule 19b-4(f)(4) \3\ thereunder so that the proposal was
effective upon filing with the Commission. The Commission is publishing
this notice to solicit comments on the rule change from interested
parties.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \3\ 17 CFR 240.19b-4(f)(4).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The proposed rule change will provide an interpretation to Rule 401
to allow clearing members to use OCC systems to update certain non-
critical trade data with respect to exchange transactions involving
securities options provided such updates do not contravene any rule of
the exchange on which such transactions were effected.

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

    In its filing with the Commission, OCC 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. OCC has prepared summaries, set forth in sections (A),
(B), and (C) below, of the most significant aspects of these
statements.\4\
---------------------------------------------------------------------------

    \4\ The Commission has modified the text of the summaries
prepared by OCC.
---------------------------------------------------------------------------

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

    The purpose of this proposed rule change is to provide an
interpretation to Rule 401 to allow clearing members to use OCC systems
to update certain non-critical trade data with respect to exchange
transactions involving securities options provided such updates do not
contravene any rule of the exchange on which such transactions were
effected. Examples of non-critical option trade data that would
eligible for updating by clearing members include: open/close
indicators, account type, account numbers, Clearing Member Trade
Assignment clearing member numbers, and optional data field remarks.
    Rule 401 concerns the reporting of matching trade information by
exchanges to OCC. An interpretation to Rule 401 allows clearing members
to use OCC systems to update certain non-critical trade data with
respect to exchange transactions involving futures provided such
updates do not contravene any rule of the exchange on which such
transaction was effected. Clearing members recently have asked that OCC
expand this to cover options transactions. The request was processed
through the OCC Roundtable, an advisory group comprised of clearing
members, options exchanges, and service bureaus, which assesses
operational improvements that may be implemented at OCC to increase
efficiencies and lower costs to industry participants.
    As in exchange transactions involving futures, OCC's systems would
be configured to ``bust'' the submitted trade and to add a new trade
that includes the change. This provides an audit trail for OCC and the
affected exchange. OCC also would provide functionality to allow an
exchange to prevent such updates from happening at OCC for trades
executed on its market.
    To accommodate this request, a minor change will be made to
Interpretation and Policy .02 to Rule 401. The change will allow
clearing members to use OCC's systems to update non-critical trade
information with respect to all exchange transactions involving
securities options with the restriction that such updates may not be in
contravention of any rule of the exchange on which the transaction was
effected. The proposed rule change is not inconsistent with the By-Laws
and Rules of OCC.

(B) Self-Regulatory Organization's Statement on Burden on Competition

    OCC does not believe that the proposed rule change will have any
impact or impose any burden on competition.

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

    Written comments relating to the proposed rule change have not been
solicited or received. OCC will notify the Commission of any written
comments received by OCC.

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

    The foregoing proposed rule change has become effective upon filing
pursuant to Section 19(b)(3)(A)(iii) of the Act \5\ and Rule 19b-
4(f)(4) \6\ thereunder because the proposed rule change affects a
change in an existing service of OCC that: (i) does not adversely
affect the safeguarding of securities or funds within the custody or
control of OCC or for which OCC is responsible; and (ii) does not
significantly affect the respective rights or obligations of clearing
members which would use the service or of OCC. At any time within 60
days of the filing of the proposed rule change, the Commission
summarily may temporarily suspend such rule change if it appears to the
Commission that such action is necessary or appropriate in the public
interest, for the protection of investors, or otherwise in furtherance
of the purposes of the Act.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \6\ 17 CFR 240.19b-4(f)(4).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-OCC-2011-07 on the subject line.

Paper Comments

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

    All submissions should refer to File Number SR-OCC-2011-07. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for 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 a.m. and 3 p.m. Copies of such filings also will be
available for inspection and copying at the principal office of OCC and
on OCC's Web site at http://www.optionsclearing.com/components/docs/legal/rules_and_bylaws/sr_occ_11_07.pdf.
    All comments received will be posted without change; the Commission
does not edit personal identifying information from submissions. You
should submit only information that you wish to make available
publicly. All submissions should refer to File Number SR-OCC-2011-07
and should be submitted on or before July 14, 2011.

    For the Commission by the Division of Trading and Markets,
pursuant to delegated authority.\7\
---------------------------------------------------------------------------

    \7\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Cathy H. Ahn,
Deputy Secretary .
[FR Doc. 2011-15659 Filed 6-22-11; 8:45 am]
BILLING CODE 8011-01-P


To:   DSW Rulemaking Record

From:  Marilyn Goode

Subject:  DSW Supplemental Proposal of March 26, 2007

On April 2, 3, and 4, 2007, I had several phone conversations with Neil King of Wilmer Cutler Pickering, who represents Inmetco.  He made the following suggestions for changes he would like to see in the final rule:

1.  On p. 162 and other places in the economic analysis (Case Study #2),

we refer to Inmetco recovering nickel and cadmium from EAF dust.  That

should be nickel and chromium.  They recover cadmium mainly from batteries.

2.  260.10, definition of hazardous secondary material generated and reclaimed

under the control of the generator - part 3 says " such material is

generated pursuant to a written contract between a tolling contractor and

batch manufacturer and are reclaimed by the tolling contractor.... ".

This should read  "......... and is reclaimed by the tolling

contractor........".

3.  261.4(a)(23)(iv).  Regarding reclaimer notifications, we say that the

reclaimer must identify "when the material will begin to be managed in

accordance with this conditional exclusion.  Since elsewhere we say that

the (a)(23) exclusion has no conditions, it would be better to drop the

word "conditional" here.

4. 261.2(g)(1).  We say that hazardous secondary material that is not

legitimately recycled is discarded and is a waste.  We then say that

"persons who recycle such materials.... must be able to demonstrate that

the recycling is legitimate. In order to avoid people thinking that "such

materials" refers back to discarded stuff, we should replace this phrase

with "persons who recycle hazardous secondary materials....must be able to

demonstrate....".

5.  261.2(g)(2)(ii)(B).  We say that a product or intermediate is valuable

if it is ..... "used by the recycler or the generator as an effective

substitute for a commercial product or as an ingredient or intermediate in

an industrial process" . We should clarify that the word "generator"

refers to the generator of the hazardous secondary material, not the

generator of the product.  The steel people generate the K061, Inmetco reclaims the metals, sends them back to the steel people who use it to make steel products.  So the "valuable product" here is the K061 reclaimed by Inmetco that the steel people (the generators of the

original hazardous secondary material) use as an ingredient to make steel

products.

6..  261.4(a)(23) - Introductory paragraph and 261.4(a)(23(i) - replace

current language with "hazardous secondary material generated and

reclaimed within the U.S. or its territories is not a solid waste provided

that (i) while it is managed in a land-based unit as defined in 260.10,

the material is contained; and............ ".  This change would make the

structure of (i) parallel with (ii) and (iii).

7.     261.4(a)(24)(v) - need to clarify whether these conditions apply to

reclaimers who have a permit because of non-excluded waste that they also

handle.

8.  261.4(a)(24(v)(C) - the first sentence about managing residuals in a

manner that is protective of hh&e - is it meant to illustrate the second

sentence about managing characteristic/listed wastes under Subtitle C, or

does it set up a separate and additional standard?

9. 261.4(a)(24)(vi) - We say that a reclamation facililty which manages

materials under this exclusion may also accept fully regulated waste.

Then we say that "such materials are not solid waste"  - we mean the

excluded material and not the fully regulated stuff, right?  We should

rephrase this to make it clear.  Then we say that "the RCRA regulatory

status of the reclamation facility will not be affected, provided that the

reclamation facility complies with....."  This sentence is confusing, and

we need to spell out what we mean exactly.

Substantive comments:

1.  Our idea that a tolling contractor (rather than the batch

manufacturer) is in essence the "generator" of a hazardous secondary

material is really a fiction. Our regs say that the tolling contractor

must retain responsibility for the hazardous secondary material.

Inmetco's contracts work the other way - they reclaim EAF and send it back

to the steel people and the contracts specify that Inmetco retains

responsibility for the material. They don't think the steel people will

want the responsibility, and would prefer not to change the form of their

contracts.

2.  If we prohibit the use of brokers or intermediaries for the (a)(24)

exclusion, we may discourage the recycling of F006, because sometimes F006

is aggregated by middlemen to take advantage of economies of scale in

transportation.  Sometimes electroplaters would find it too expensive to

ship their stuff all by itself to a reclaimer.

3.  We should clarify whether destination facilities handling universal waste can

choose to be excluded under 261.4(a)(24) even when the generator prefers

to stay classified as a universal waste handler.